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A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for...
Arcus Biosciences, Inc.
Advanced Upper Gastrointestinal Tract Adenocarcinoma
This randomized Phase 3 open-label study will compare the efficacy of the T-cell
immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT)
monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal
antibody zimberelimab,... expand
This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma. Type: Interventional Start Date: Nov 2022 |
Sleep for Stroke Management and Recovery Trial
University of Michigan
Ischemic Stroke
Sleep Apnea
Sleep Apnea, Obstructive
TIA
Stroke
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA)
with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA
(1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after... expand
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke. Type: Interventional Start Date: May 2019 |
Mobile Mental Health Stigma Reduction Intervention Among Black Adults
Massachusetts General Hospital
Anxiety
Depression
Health Knowledge, Attitudes, Practice
Stigmatization
Mobile Phone Use
Major depressive and anxiety disorders are highly prevalent in the general population and are
a leading cause of disability. Black adults have a high burden of depression and anxiety.
This study aims to assess a self- administered video-based intervention to reduce mental... expand
Major depressive and anxiety disorders are highly prevalent in the general population and are a leading cause of disability. Black adults have a high burden of depression and anxiety. This study aims to assess a self- administered video-based intervention to reduce mental illness stigma and medical mistrust among Black adults with moderate to severe depression or anxiety. Type: Interventional Start Date: Mar 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).... 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 |
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.
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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 |
PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer
Lantheus Medical Imaging
Prostate Cancer
The purpose of this study is to learn whether PYLARIFY PET imaging (study scan) can safely
and accurately detect the presence or absence of prostate cancer growing beyond the prostate
gland in men with favorable intermediate risk prostate cancer.
Participants will receive... expand
The purpose of this study is to learn whether PYLARIFY PET imaging (study scan) can safely and accurately detect the presence or absence of prostate cancer growing beyond the prostate gland in men with favorable intermediate risk prostate cancer. Participants will receive a single dose of PYLARIFY injection followed by a single whole-body PET/CT or PET/MRI scan acquired at 1 to 2 hours after PYLARIFY injection. Participants with positive study scan results that are suspicious for prostate cancer outside of the prostate gland may be asked to undergo additional diagnostic test(s) and/or recommend certain treatment(s) for prostate cancer within 2 to 90 days after the study scan. Participants will be monitored for up to 12 months to collecting information about treatment they receive for prostate cancer and results of regular PSA blood draws if ordered by doctors for up to 12 months after the study scan. Type: Interventional Start Date: Feb 2024 |
GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
Massachusetts General Hospital
Genetic Predisposition
Metabolic Diseases
Type 2 Diabetes
The goal of this research study is to evaluate the pathophysiologic mechanisms by which
genetic variation impacts response to an FDA-approved medication commonly used to treat type
2 diabetes called oral semaglutide (Rybelsus) and to characterize the physiological response... expand
The goal of this research study is to evaluate the pathophysiologic mechanisms by which genetic variation impacts response to an FDA-approved medication commonly used to treat type 2 diabetes called oral semaglutide (Rybelsus) and to characterize the physiological response to a mixed meal tolerance test (MMTT) before and after a 14-day treatment with oral semaglutide. The investigators will do this by measuring factors in the blood, such as sugars, fats, metabolites, and proteins, after eating a standardized breakfast meal at the first visit and after taking 14 doses of oral semaglutide over two weeks before the second study visit. The food (mixed meal breakfast) we will be studying is specially prepared to contain a set amount of protein, carbohydrates, and fat. The investigators hypothesize that understanding how the acute biochemical response to oral semaglutide differs by genetic variation will generate insight into drug mechanisms and type 2 diabetes pathophysiology. Type: Interventional Start Date: Mar 2024 |
Hyperbaric Oxygen Therapy for Ulcerative Colitis
Northwestern University
Ulcerative Colitis
Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative
colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased
atmospheric pressure to increase tissue oxygenation. Two small prospective randomized... expand
Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased atmospheric pressure to increase tissue oxygenation. Two small prospective randomized controlled trials have demonstrated that the delivery of HBOT to UC patients hospitalized for acute moderate to severe flares results in improved remission rates and avoidance of in-hospital progression to biologics, small molecules, or colectomy. In this larger trial the study aims to confirm the treatment benefits of HBOT for hospitalized UC patients and study the immune-microbe mechanisms underpinning treatment response. Type: Interventional Start Date: Jan 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,... 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 |
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus...
Genentech, Inc.
Adenocarcinoma, Pancreatic Ductal
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene
cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and
oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic
ductal... expand
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery. Type: Interventional Start Date: Oct 2023 |
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Shockwave Medical, Inc.
Coronary Artery Disease
Post-market, prospective, multi-center, single-arm observational study to generate real-world
clinical evidence associated with coronary IVL in a population of female subjects with
calcified coronary artery disease.
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Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease. Type: Observational Start Date: May 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... 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 |
Tau PET/CT Imaging in the Mismatch Prospective Cohort Study (MPC-TAU)
University of Pennsylvania
Alzheimer's Disease
To collect Tau PET/CT imaging in older adults diagnosed with Mild Cognitive Impairment (MCI)
or Alzheimer's Disease (AD) in the Mismatch Prospective Cohort Study (MPC-Tau) study to
determine relationship to clinical, cognitive, and other biomarker data. Findings from this... expand
To collect Tau PET/CT imaging in older adults diagnosed with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) in the Mismatch Prospective Cohort Study (MPC-Tau) study to determine relationship to clinical, cognitive, and other biomarker data. Findings from this study will likely provide insight into the phenotypic variability of Alzheimer's Disease and other related pathologies. Type: Observational Start Date: Mar 2023 |
A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy
Bristol-Myers Squibb
Cardiomyopathy, Hypertrophic
The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten
compared with placebo in participants with symptomatic non-obstructive hypertrophic
cardiomyopathy (nHCM).
expand
The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). Type: Interventional Start Date: Dec 2022 |
A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe...
Eli Lilly and Company
Atopic Dermatitis
Eczema
The main purpose of this study is to measure the effect, safety and how well the body absorbs
lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe
atopic dermatitis (AD).
expand
The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD). Type: Interventional Start Date: Oct 2022 |
A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal...
Bristol-Myers Squibb
Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the safety of mavacamten in patients with
symptomatic obstructive hypertrophic cardiomyopathy (HCM) treated in the real-world setting.
The registry study also provide a real-world understanding of the current obstructive HCM
patient... expand
The purpose of this study is to evaluate the safety of mavacamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) treated in the real-world setting. The registry study also provide a real-world understanding of the current obstructive HCM patient population, treatment patterns, and clinical relevant outcomes for patients with symptomatic obstructive HCM in the US. Type: Observational [Patient Registry] Start Date: Aug 2022 |
A Study to Investigate the Safety and Tolerability of Intravenous QEQ278 in Patients With Advanced Solid...
Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Esophageal Squamous Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary
anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung
cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus... expand
To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell carcinoma. Type: Interventional Start Date: Apr 2023 |
Boosting Emotional Well-being and Happiness in Outpatients Living With Diabetes
Massachusetts General Hospital
Diabetes Mellitus, Type 2
The focus of this study is to test the efficacy of an 8-week, remotely delivered,
positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice
weekly text messages for a total of 16 weeks (with interactive, algorithm-driven,
goal-focused text messages... expand
The focus of this study is to test the efficacy of an 8-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 16 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 8 weeks), compared to MI-alone, in a randomized trial of 280 individuals with type 2 diabetes and low baseline physical activity. Type: Interventional Start Date: Oct 2022 |
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... 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 |
EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction
Amgen
Cardiovascular Disease
Myocardial Infarction
Stroke
Coronary Revascularization
The primary objective of this study is to evaluate the effectiveness of early treatment with
evolocumab plus routine lipid management vs routine lipid management alone when administered
in the acute setting to reduce myocardial infarction, ischemic stroke, arterial
revascularization,... expand
The primary objective of this study is to evaluate the effectiveness of early treatment with evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction [NSTEMI] and ST-segment elevation myocardial infarction [STEMI]). Type: Interventional Start Date: Oct 2022 |
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis...
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Diffuse Cutaneous Systemic Sclerosis
Interstitial Lung Disease
The purpose of this study is to assess the safety and efficacy of tulisokibart in
participants with SSc-ILD.
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The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD. Type: Interventional Start Date: Jul 2022 |
A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Janssen Research & Development, LLC
Multiple Myeloma
The purpose of this study is to collect long-term follow-up data on delayed adverse events
after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and
understand the long-term safety profile of cilta-cel.
expand
The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel. Type: Interventional Start Date: Mar 2022 |
ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)
MapLight Therapeutics
Autism Spectrum Disorder
ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled
study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary
objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of... expand
ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits in subjects with ASD. Type: Interventional Start Date: Sep 2022 |
ASPIRED-XT: ASPirin Intervention for the REDuction of Colorectal Cancer Risk -EXTension
Massachusetts General Hospital
Colorectal Cancer
This research study is studying a drug intervention as a possible chemoprevention strategy
for colorectal cancer.
The name of the study intervention involved in this study is:
- Low Dose Aspirin
expand
This research study is studying a drug intervention as a possible chemoprevention strategy for colorectal cancer. The name of the study intervention involved in this study is: - Low Dose Aspirin Type: Interventional Start Date: Jun 2022 |
Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy
Massachusetts General Hospital
Adrenoleukodystrophy
Restless Legs Syndrome
The investigators recently observed that up to 25% of women with X-linked
adrenoleukodystrophy (ALD) have moderate to severe Restless Leg Syndrome (RLS). In this
study, the investigators aim to estimate the prevalence of RLS among women with ALD and to
assess whether pramipexole... expand
The investigators recently observed that up to 25% of women with X-linked adrenoleukodystrophy (ALD) have moderate to severe Restless Leg Syndrome (RLS). In this study, the investigators aim to estimate the prevalence of RLS among women with ALD and to assess whether pramipexole improves RLS symptoms as well as sleep and gait measures in women with ALD. Type: Interventional Start Date: Apr 2023 |
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