Trials with a site in Gainesville, Florida

Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies.

NCT02418442 · Official ClinicalTrials.gov record · Duke University

This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries.

NCT04251052 · Official ClinicalTrials.gov record · NRG Oncology

This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT04267848 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or unmethylated in adults only) and (Stratum 2) in pediatric patients with newly diagnosed HGG (pHGG).

NCT04573140 · Official ClinicalTrials.gov record · University of Florida

This study wants to test the safety and how well it works of BHV-3000 versus dummy treatment (placebo) in the acute treatment of moderate or severe migraine in children and adolescents.

NCT04649242 · Official ClinicalTrials.gov record · Pfizer

This study will measure the how well it works and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.

NCT04781140 · Official ClinicalTrials.gov record · Supernus Pharmaceuticals, Inc.

To find out if eptinezumab is better than dummy treatment (placebo) (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

NCT04965675 · Official ClinicalTrials.gov record · H. Lundbeck A/S

The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

NCT05164172 · Official ClinicalTrials.gov record · H. Lundbeck A/S

This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials.

NCT05564377 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates.

NCT05675410 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with or without nivolumab to the effect of modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with or without nivolumab for the treatment of patients with advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, or gastric adenocarcinoma. The usual approach for patients who are not in a study is treatment with FOLFOX with some receiving an immunotherapy drug, either nivolumab or pembrolizumab, in addition to FOLFOX chemotherapy.

NCT05677490 · Official ClinicalTrials.gov record · Alliance for Clinical Trials in Oncology

This study is researching an experimental drug called linvoseltamab, also called REGN5458. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed.

NCT05730036 · Official ClinicalTrials.gov record · Regeneron Pharmaceuticals

REACT-AF is a multicenter prospective, randomly assigned, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.

NCT05836987 · Official ClinicalTrials.gov record · Johns Hopkins University

This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans.

NCT05987241 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This is a multi-center evaluation of efruxifermin (EFX) in a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

NCT06215716 · Official ClinicalTrials.gov record · Akero Therapeutics, Inc

This is a multicenter, global, 26-week, open-label study to assess the whether it is safe and how hard side effects are to live with of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.

NCT06229210 · Official ClinicalTrials.gov record · Intra-Cellular Therapies, Inc.

Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications. LIVER-R is a multi-country, multi-center, watch-and-measure (no experimental treatment required) study of patients with a confirmed diagnosis of hepatobiliary cancer treated with or without a durvalumab-based regimen as part of routine clinical practice or early access program (EAP).

NCT06252753 · Official ClinicalTrials.gov record · AstraZeneca

This is a Phase III, international, multi-centre, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to measure the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.

NCT06307652 · Official ClinicalTrials.gov record · AstraZeneca

This phase II ADC MATCH screening and multi-sub-study treatment trial is evaluating whether biomarker-directed treatment with one of three antibody-drug conjugates (ADCs) (sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan) works in treating patients with solid tumor cancers that have high expression of the Trop-2, nectin-4, or HER2 proteins and that may have spread from where they first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or to other places in the body (metastatic). Precision medicine is a form of medicine that uses information about a person's genes, proteins, and environment to prevent, diagnose, or treat disease in a way that is tailored to the patient.

NCT06311214 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

The study will assess the how well it works and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .

NCT06419374 · Official ClinicalTrials.gov record · Hoffmann-La Roche

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more.

NCT06424288 · Official ClinicalTrials.gov record · Boehringer Ingelheim

The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.

NCT06526195 · Official ClinicalTrials.gov record · Abbott Medical Devices

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss.

NCT06548542 · Official ClinicalTrials.gov record · AbbVie

This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT06580314 · Official ClinicalTrials.gov record · NRG Oncology

This study wants to measure the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.

NCT06617325 · Official ClinicalTrials.gov record · UCB Biopharma SRL

The overarching goal of this study is to determine if baricitinib, as compared to dummy treatment (placebo), will improve neurocognitive function, along with measures of physical function, quality of life, post-exertional malaise, effect of breathlessness on daily activities, post-COVID-19 symptom burden, and biomarkers of inflammation and viral measures, in participants with Long COVID.

NCT06631287 · Official ClinicalTrials.gov record · Wes Ely

The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYS™ hip navigation system with CUPTIMIZE™ Advanced Hip-Spine Analysis software. Data collected in this study will be compared with data collected from implantations using different cup positioning instrumentation and techniques to assess performance.

NCT06631638 · Official ClinicalTrials.gov record · DePuy Orthopaedics

This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. this study wants to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.

NCT06632444 · Official ClinicalTrials.gov record · Boehringer Ingelheim

This study wants to assess the long-term whether it is safe and how hard side effects are to live with after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

NCT06635148 · Official ClinicalTrials.gov record · Janssen Research & Development, LLC

This study is an open-label, randomly assigned, multicenter trial that incorporates a multi-arm design comparing each of 3 non-TNFi (Tumor Necrosis Factor inhibitor) medications to a second TNFi (active control) within a sequential multiple assignment randomly assigned trial design with 2 randomization stages corresponding with clinical decision points. The first randomization addresses whether each of the 3 non-TNFi medications is superior to treatment with a second TNFi.

NCT06654882 · Official ClinicalTrials.gov record · Duke University

This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT06661720 · Official ClinicalTrials.gov record · Alliance for Clinical Trials in Oncology

Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments.

NCT06677060 · Official ClinicalTrials.gov record · AstraZeneca

This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to assess the how well it works, safety, and tolerability of ITI-1284 as this drug alone treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.

NCT06701903 · Official ClinicalTrials.gov record · Intra-Cellular Therapies, Inc.

This study wants to determine the PK, whether it is safe and how hard side effects are to live with of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA

NCT06751238 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT06770582 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) followed by glofitamab this drug alone treatment regimen (Cohort A), and for glofitamab this drug alone (Cohort B) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.

NCT06806033 · Official ClinicalTrials.gov record · Hoffmann-La Roche

The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans. Until recently, the only medical treatment options available for patients with CRSwNP were corticosteroids, with surgery reserved for medical failure.

NCT06824649 · Official ClinicalTrials.gov record · Medical University of South Carolina

The purpose of this Phase 3b study is to assess the how well it works, whether it is safe and how hard side effects are to live with of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).

NCT06846281 · Official ClinicalTrials.gov record · Novartis Pharmaceuticals

A Multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, Parallel Group, Phase 3 Study to measure the how well it works and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT06883305 · Official ClinicalTrials.gov record · AstraZeneca

This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study.

NCT06935370 · Official ClinicalTrials.gov record · Boehringer Ingelheim

Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent. * EC is a type of cancer that starts in the tissues inside the uterus (womb) * pMMR indicates that certain normal proteins are present in the cancer cells * Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery * Recurrent means the cancer came back after surgery Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines.

NCT06952504 · Official ClinicalTrials.gov record · Merck Sharp & Dohme LLC

This multi-center randomly assigned controlled trial will assess the safety and how well it works of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \<21 with recent-onset stage 3 T1D.

NCT07061574 · Official ClinicalTrials.gov record · City of Hope Medical Center

A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy

NCT07100080 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

This study will explore the use of glucagon-like peptide 1 receptor agonist (GLP-1RA) used concurrently with levonorgestrel intrauterine device in patients with poor surgical candidacy for a hysterectomy or patients who are pursuing fertility sparing. GLP-1RA are a class of medications that mimic the natural hormone glucagon-like peptide-1.

NCT07107334 · Official ClinicalTrials.gov record · University of Florida

This study wants to measure the how well it works, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.

NCT07144163 · Official ClinicalTrials.gov record · Crinetics Pharmaceuticals Inc.

The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO.

NCT07165028 · Official ClinicalTrials.gov record · Eli Lilly and Company

This is a sequential Phase 1/2, two-part, multicenter study on safety, tolerability, and how well it works of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). The core phase duration will be approximately 2 years for each participant.

NCT07215234 · Official ClinicalTrials.gov record · Sanofi

The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 90 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.

NCT07227246 · Official ClinicalTrials.gov record · Joseph Broderick, MD

The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. Additional information is available at www.SOLAIRIA.com.

NCT07276724 · Official ClinicalTrials.gov record · Generate Biomedicines

This study wants to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

NCT07284745 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

This study wants to measure the how well it works and safety of AZD5148 for prevention of recurrence of Clostridioides difficile infection in Individuals 18 years of age and above.

NCT07285213 · Official ClinicalTrials.gov record · AstraZeneca

This study wants to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

NCT07285798 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

This pilot mixed-method study will measure the feasibility, preliminary how well it works, and user experience of a home-based wearable Focal Vibration Therapy (FVT) intervention for improving upper extremity (UEx) function in people with multiple sclerosis (MS). Fifteen adults with relapsing-remitting MS (PRMS) and self-reported UEx impairments will participate in a 4-week FVT program using MyovoltTM wearable FVT devices applied to arm muscles.

NCT07376772 · Official ClinicalTrials.gov record · University of Florida

This study wants to measure the long-term whether it is safe and how hard side effects are to live with of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents

NCT07424404 · Official ClinicalTrials.gov record · Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Researchers are looking for new ways to treat high-risk, localized non-small cell lung cancer (NSCLC) that has been removed with surgery. People with high-risk, localized NSCLC are often treated with surgery.

NCT07513376 · Official ClinicalTrials.gov record · Merck Sharp & Dohme LLC

The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.

NCT07589595 · Official ClinicalTrials.gov record · Eli Lilly and Company

This study wants to measure the how well it works of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to dummy treatment (placebo) in combination with chemotherapy.

NCT07621718 · Official ClinicalTrials.gov record · Revolution Medicines, Inc.

This study wants to measure the how well it works, whether it is safe and how hard side effects are to live with of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to \< 45 mL/min/1.73 m2) administered orally once daily in addition to SoC. This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from treatment trials.

NCT07624305 · Official ClinicalTrials.gov record · AstraZeneca

Researchers are looking for new ways to treat diabetic macular edema (DME). In this trial, researchers want to learn if a trial medicine called MK-8748 can treat DME.

NCT07705555 · Official ClinicalTrials.gov record · Merck Sharp & Dohme LLC

This study is a Phase 3, multi-center, randomly assigned, 6-week, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial to assess the how well it works and safety of solriamfetol in children aged 6 to \<12 years with ADHD.

NCT07717879 · Official ClinicalTrials.gov record · Axsome Therapeutics, Inc.

This study is a Phase 3, multi-center, randomly assigned, 6-week, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial to assess the how well it works and safety of solriamfetol in adolescents aged 12 to \<18 years with ADHD.

NCT07717892 · Official ClinicalTrials.gov record · Axsome Therapeutics, Inc.

This is a global, phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, 3-arm, compared with a dummy treatment, multicenter study designed to compare the how well it works, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \[mg/day\]) to dummy treatment (placebo) in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.

NCT07759128 · Official ClinicalTrials.gov record · Otsuka Pharmaceutical Development & Commercialization, Inc.

The primary purpose of this study is to measure the how well it works of centanafadine once daily (QD) extended-release (XR) capsules in adults with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED).

NCT07759154 · Official ClinicalTrials.gov record · Otsuka Pharmaceutical Development & Commercialization, Inc.