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Global Prospective, Observational Cohort of Adult Patients with Primary Sclerosing Cholangitis (WIND-PSC...
PSC Partners Seeking a Cure
PSC
Develop an appropriate real-world data comparator cohort to support the design,
execution, and serve as an external control for interventional clinical trials in PSC. expand
Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC. Type: Observational Start Date: May 2024 |
A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors
Eli Lilly and Company
Metastatic Solid Tumor
Recurrent Solid Tumor
Advanced Solid Tumor
Urinary Bladder Neoplasm
Triple Negative Breast Cancer
The purpose of this study is to find out whether the study drug, LY4101174, is safe,
tolerable and effective in participants with advanced, or metastatic solid tumors. The
study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase
Ib (dose-expansion). The study will... expand
The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years. Type: Interventional Start Date: Mar 2024 |
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Vedanta Biosciences, Inc.
Clostridium Difficile
Clostridium Difficile Infections
Clostridium Difficile Infection Recurrence
Clostridioides Difficile Infection
Clostridioides Difficile Infection Recurrence
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the
Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who
receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are
identical for Stage 1 (recurrent CDI) and... expand
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI). Type: Interventional Start Date: May 2024 |
A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors
Immuneering Corporation
Advanced Solid Tumor (Phase 1)
Pancreas Adenocarcinoma
Non-small Cell Lung Cancer
Malignant Melanoma (Cutaneous)
This is a FIH, ascending dose study to characterize the safety, tolerability, optimal
dose and preliminary anti-tumor activity of IMM-6-415 in participants with advanced or
metastatic solid tumors harboring RAS or RAF oncogenic mutations. expand
This is a FIH, ascending dose study to characterize the safety, tolerability, optimal dose and preliminary anti-tumor activity of IMM-6-415 in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic mutations. Type: Interventional Start Date: Feb 2024 |
A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine...
Bristol-Myers Squibb
Carcinoma, Non-Small-Cell Lung
The purpose of this study is to evaluate the efficacy and safety of repotrectinib and
crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive
non-small cell lung cancer (NSCLC). expand
The purpose of this study is to evaluate the efficacy and safety of repotrectinib and crizotinib in participants with locally advanced or metastatic TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC). Type: Interventional Start Date: Dec 2023 |
A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer
Memorial Sloan Kettering Cancer Center
Esophageal Cancer
Gastric Adenocarcinoma
HER2 Gene Mutation
The purpose of this study to find out whether adding trastuzumab and pembrolizumab to
standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric
cancer. expand
The purpose of this study to find out whether adding trastuzumab and pembrolizumab to standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric cancer. Type: Interventional Start Date: Feb 2024 |
IDE196 (Darovasertib) in Combination with Crizotinib As First-line Therapy in Metastatic Uveal Melanoma
IDEAYA Biosciences
Metastatic Uveal Melanoma
This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen
(HLA)-A*02:01 negative participants with metastatic uveal melanoma (MUM) who will be
randomized to receive either IDE196 + crizotinib or investigator's choice of treatment
(pembrolizumab, ipilimumab + nivolumab,... expand
This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine). Type: Interventional Start Date: Oct 2023 |
Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
Massachusetts General Hospital
Electronic Cigarette Use
The goal of this study is to conduct a pilot randomized waitlist-controlled trial to
assess the feasibility, acceptability, and preliminary effects of substituting the NIDA
standardized research e-cigarette (SREC) for combusted cigarettes in MOUD-TUD who are not
ready to quit smoking. A waitlist controlled... expand
The goal of this study is to conduct a pilot randomized waitlist-controlled trial to assess the feasibility, acceptability, and preliminary effects of substituting the NIDA standardized research e-cigarette (SREC) for combusted cigarettes in MOUD-TUD who are not ready to quit smoking. A waitlist controlled RCT using a mixed-methods sequential explanatory design will investigate the impact of SREC provision on: 1) tobacco use behavior (e.g., cigarettes per day [primary outcome], SREC use), 2) biomarkers (e.g., carbon monoxide, anabasine), 3) cigarette dependence and withdrawal, and 4) short-term health effects and tolerability (e.g., respiratory symptoms, substance use). In the proposed RCT, N=40 adults stable on MOUD with buprenorphine who report daily smoking recruited from MGH primary care practices will be randomly assigned to receive the SREC for 8 weeks, either immediately (iSREC), or after an 8-week delay (waitlist control [WLC]). They will be followed an additional 4 weeks after SREC provision ends (to 12 weeks in iSREC and 20 weeks in WLC). Type: Interventional Start Date: Jun 2024 |
Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation...
University of Minnesota
COVID-19
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that
immune modulation can improve outcomes in hospitalized patients. This trial is designed
to determine whether intensification of immune modulation early in the course of the
disease (while patients are on low... expand
COVID-19 can trigger a dysregulated immune response, and previous studies have shown that immune modulation can improve outcomes in hospitalized patients. This trial is designed to determine whether intensification of immune modulation early in the course of the disease (while patients are on low flow oxygen) with abatacept (active arm) combined with standard of care (SOC) improves recovery as compared with placebo + SOC (placebo arm). For both groups, intensification of immunomodulation will be provided as part of SOC in case of signs of disease progression (patient requires high flow nasal oxygen (HFNO) or more support) and/or if the patient has rapidly increasing oxygen requirement. Type: Interventional Start Date: Jul 2023 |
Nutrition for Precision Health, Powered by the All of Us
RTI International
Nutrition
Health
Dietary Habits
The goal of this investigational study is to develop algorithms that predict human
response to foods. The main question it aims to answer are:
- How does varying foods and eating patterns impact one's biological and physiological
responses?
- In what ways can novel dietary assessment... expand
The goal of this investigational study is to develop algorithms that predict human response to foods. The main question it aims to answer are: - How does varying foods and eating patterns impact one's biological and physiological responses? - In what ways can novel dietary assessment measures be used to improve dietary assessments and to prescribe assessments to people in future research with increased precision? - Can artificial intelligence and machine learning techniques be combined to prescribe foods and eating patterns to individuals for optimization of their health? There are 3 Modules participants may take part in: - Module 1- A participant's dietary intake and accompanying nutritional status, biological and other measures will be observed over 10 days, as well as physiological responses to a liquid mixed meal tolerance test will be measured. - Module 2- Participants will undergo three controlled dietary interventions provided for 14-days each and separated by washout periods of at least 14 days. Physiological responses following a diet-specific meal test will be measured. - Module 3- Participants will undergo the same three dietary interventions during the same 14 day periods as Module 2 while being studied in-residence. Physiological responses following a liquid mixed meal tolerance test and a diet-specific meal test will be measured. Type: Interventional Start Date: Apr 2023 |
A Study of GV20-0251 Monotherapy and GV20-0251 in Combination with Pembrolizumab in Participants with...
GV20 Therapeutics
Solid Tumor, Adult
Refractory Cancer
Endometrial Carcinoma (EC)
Squamous Head and Neck Carcinoma
PMMR/MSS Adenocarcinoma of the Colon or Rectum
This is a Phase 1/2A study of GV20-0251 being developed for the treatment of participants
with advanced solid tumors, who are refractory to approved therapies or other standard of
care. expand
This is a Phase 1/2A study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care. Type: Interventional Start Date: Mar 2023 |
A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal...
Bristol-Myers Squibb
Obstructive Hypertrophic Cardiomyopathy
This registry evaluates patient characteristics, real-world treatment patterns, and
short- and long-term outcomes in a population of patients in the United States and Europe
with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving
mavacamten, receiving other treatment for obstructive... expand
This registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving mavacamten, receiving other treatment for obstructive HCM, or not receiving treatment for obstructive HCM due to intolerance or failure of prior treatment. United States Sub-Study: The purpose of this study is to evaluate the safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting. Europe Sub-Study: The purpose of this study is to evaluate the effectiveness and safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting. Type: Observational [Patient Registry] Start Date: Aug 2022 |
Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal...
Kardium Inc.
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System
for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF). expand
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF). Type: Interventional Start Date: Mar 2023 |
A Study to Assess the Safety of BIIB122 Tablets and if it Can Slow the Worsening of Early-Stage Parkinson's...
Biogen
Parkinson Disease
In this study, researchers will learn more about a study drug called BIIB122 in
participants with early-stage Parkinson's disease (PD). In this study:
- Participants will take 225 milligrams (mg) of BIIB122 or a placebo as tablets by
mouth. A placebo looks like the study drug but has no... expand
In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). In this study: - Participants will take 225 milligrams (mg) of BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but has no real medicine in it. - Participants will take BIIB122 or placebo 1 time a day for up to a minimum of 48 weeks and a maximum of 144 weeks. - Certain medications for PD will be allowed at enrollment for a subset of participants. - Participants will have to visit at 2-week intervals between baseline and week 12 and at 4-week intervals between week 12 and week 48 and at 12 week intervals between week 48 and week 144. The main question researchers are trying to answer is if taking BIIB122 slows the worsening of symptoms more than placebo in the early stages of PD. To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS. Researchers will use the MDS-UPDRS to learn about participant PD symptoms and how they affect their daily life. Researchers will also learn more about the safety of BIIB122. Type: Interventional Start Date: Apr 2022 |
Study of MGY825 in Patients With Advanced Non-small Cell Lung Cancer
Novartis Pharmaceuticals
Non-small Cell Lung Cancer
Study of MGY825 single agent in adult patients with advanced non-small cell lung cancer. expand
Study of MGY825 single agent in adult patients with advanced non-small cell lung cancer. Type: Interventional Start Date: Oct 2022 |
Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
Center for International Blood and Marrow Transplant Research
Acute Myeloid Leukemia in Remission
Prospective determination of the clinical utility of measurable residual disease (MRD)
testing for relapse and survival of patients with acute myeloid leukemia (AML) undergoing
allogeneic hematopoietic cell transplantation (alloHCT). expand
Prospective determination of the clinical utility of measurable residual disease (MRD) testing for relapse and survival of patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (alloHCT). Type: Observational Start Date: Aug 2022 |
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, As a Single Agent in Advanced Solid...
Relay Therapeutics, Inc.
PIK3CA Mutation
Solid Tumor, Adult
HER2-negative Breast Cancer
Breast Cancer
Metastatic Breast Cancer
This is an open-label, FIH study designed to evaluate the maximum tolerated dose,
recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary
antineoplastic activity of RLY-2608, in advanced solid tumor patients with a
Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic... expand
This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha (PIK3CA) mutation in blood and/or tumor per local assessment. The study will evaluate RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors, RLY-2608 + fulvestrant and RLY-2608 + fulvestrant + CDK4/6 inhibitor (palbociclib or ribociclib) combination arms for patients with HR+ HER2- locally advanced or metastatic breast cancer. The RLY-2608 single agent arm, RLY-2608 + fulvestrant combination arm, and triple combination arms will have 2 parts: a dose escalation (Part 1) and a dose expansion (Part 2). Type: Interventional Start Date: Dec 2021 |
A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease...
Agios Pharmaceuticals, Inc.
Sickle Cell Disease
This clinical trial is a Phase 2/3 study that will determine the recommended dose of
mitapivat and evaluate the efficacy and safety of mitapivat in sickle cell disease by
testing how well mitapivat works compared to placebo to increase the amount of hemoglobin
in the blood and to reduce or prevent... expand
This clinical trial is a Phase 2/3 study that will determine the recommended dose of mitapivat and evaluate the efficacy and safety of mitapivat in sickle cell disease by testing how well mitapivat works compared to placebo to increase the amount of hemoglobin in the blood and to reduce or prevent the occurrence of sickle cell pain crises. In addition, the long-term effect of mitapivat on efficacy and safety will be explored in an open-label extension portion. Type: Interventional Start Date: Feb 2022 |
Pancreatic Cancer Early Detection Consortium
Arbor Research Collaborative for Health
Pancreas Cancer
Pancreas Cyst
Pancreatic Ductal Adenocarcinoma
Genetic Predisposition
The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct
research on multiple aspects of early detection and prevention of pancreatic ductal
adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family
history of PDAC and/or individuals carrying... expand
The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up. Type: Observational Start Date: Sep 2020 |
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
PMV Pharmaceuticals, Inc
Advanced Solid Tumor
Advanced Malignant Neoplasm
Metastatic Cancer
Metastatic Solid Tumor
Lung Cancer
This Phase 1/2 study will assess the safety, tolerability, and efficacy of multiple dose
levels of PC14586 (INN: rezatapopt) alone (monotherapy) and in combination with
pembrolizumab in participants with advanced solid tumors containing a TP53 Y220C
mutation. expand
This Phase 1/2 study will assess the safety, tolerability, and efficacy of multiple dose levels of PC14586 (INN: rezatapopt) alone (monotherapy) and in combination with pembrolizumab in participants with advanced solid tumors containing a TP53 Y220C mutation. Type: Interventional Start Date: Oct 2020 |
TRISCEND II Pivotal Trial
Edwards Lifesciences
Tricuspid Valve Regurgitation
Tricuspid Valve Insufficiency
Tricuspid Valve Disease
Heart Valve Diseases
Cardiovascular Diseases
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid
valve replacement system expand
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system Type: Interventional Start Date: Apr 2021 |
Study of Safety, Pharmacokinetics, and Antitumor Activity of BGB-3245 in Participants With Advanced or...
MapKure, LLC
Solid Tumor
B-Raf Mutation-Related Tumors
The purpose of this study is to evaluate the safety, tolerability, and antitumor activity
of BGB-3245 in participants with advanced or refractory solid tumors expand
The purpose of this study is to evaluate the safety, tolerability, and antitumor activity of BGB-3245 in participants with advanced or refractory solid tumors Type: Interventional Start Date: Feb 2020 |
Trial of Parkinson's and Zoledronic Acid
California Pacific Medical Center Research Institute
Parkinson Disease
Osteoporosis
Parkinsonism
Parkinson's Disease and Parkinsonism
Atypical Parkinsonism
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion
of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60
years and older with Parkinson's disease and parkinsonism with at least 2 years of
follow-up. A total of 3500 participants... expand
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60 years and older with Parkinson's disease and parkinsonism with at least 2 years of follow-up. A total of 3500 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging. Type: Interventional Start Date: Nov 2019 |
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Edwards Lifesciences
Degenerative Mitral Valve Disease
Mitral Regurgitation
Mitral Insufficiency
Functional Mitral Regurgitation
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve
Repair System in patients with degenerative mitral regurgitation (DMR) who have been
determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in
patients with functional mitral regurgitation... expand
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT) Type: Interventional Start Date: Nov 2018 |
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe...
Medtronic Cardiovascular
Mitral Valve Regurgitation
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All
subjects enrolled with receive the study device. expand
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. Type: Interventional Start Date: Oct 2017 |
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