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Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial
University of Washington
Diverticulitis
The COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is
a pragmatic, patient-level randomized superiority trial of elective colectomy vs. best
medical management for patients with quality of life (QoL) limiting diverticular disease.
A parallel observational cohort w1 expand
The COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is a pragmatic, patient-level randomized superiority trial of elective colectomy vs. best medical management for patients with quality of life (QoL) limiting diverticular disease. A parallel observational cohort will include those who are disinclined to have their treatment choice randomized, but are willing to contribute information about their outcomes. The goal of the COSMID trial is to answer the question: For patients with QoL-limiting diverticular disease, is elective colectomy more effective than best medical management? The hypothesis being tested in the COSMID trial is that patient-reported outcomes (PROs) among patients in the surgery arm will be superior to those in the best medical management arm. Type: Interventional Start Date: Oct 2019 |
Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli
National Institute of Neurological Disorders and Stroke (NINDS)
Normal Physiology
Background:
An electroencephalogram (EEG) measures the brain s electrical activity. EEG shows that
the louder the sound needed to wake a person, the deeper the person s sleep. Researchers
are using functional magnetic resonance imaging (fMRI) to study people during sleep so
they can view brain act1 expand
Background: An electroencephalogram (EEG) measures the brain s electrical activity. EEG shows that the louder the sound needed to wake a person, the deeper the person s sleep. Researchers are using functional magnetic resonance imaging (fMRI) to study people during sleep so they can view brain activity in 3D. But they still need to correlate fMRI with sound thresholds, like the EEG. Objective: To measure brain activity during sleep using fMRI and EEG. Eligibility: Healthy people ages 18 34 who can sleep on their back for several hours. Design: Participants will be screened online about their sleep and general health. At a screening visit, participants will have: Physical exam Hearing exam MRI scan. A strong magnetic field and radio waves take pictures of the brain. Participants will lie down on a bed that slides into the scanner, which is shaped like a cylinder. Participants will wear an actigraph on their wrist that records their motor activity. Participants will follow a 2-week routine. This includes regular in-to-bed and out-of-bed times and limits on alcohol, caffeine, and nicotine. During the overnight visits, participants will have: Female subjects will have a urine pregnancy test. fMRI. A coil will be placed over the head. Participants will do tasks shown on a computer screen inside the scanner. EEG. Small electrodes on the scalp will record brain waves while sleeping or doing a task in the scanner. Participants will be asked to try to sleep while researchers collect fMRI and EEG data. Participants eyes will be monitored with a video camera. Headphones will deliver sounds to wake them up throughout the night. ... Type: Observational Start Date: Jan 2016 |
Rutgers University Study of the Genetics of Pulmonary Hypertension
Rutgers, The State University of New Jersey
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
Pulmonary Arterial Hypertension Associated With Connective Tissue Disease
Pulmonary Arterial Hypertension Associated With Connective Tissue Disease (Disorder)
The goal of this observational study is to learn more about how genes impact the risk of
pulmonary hypertension. Anyone 18 or older living in the US is eligible, and a diagnosis
of PH is NOT required. Study participation is online, and it takes about 20 minutes to
complete health surveys and reques1 expand
The goal of this observational study is to learn more about how genes impact the risk of pulmonary hypertension. Anyone 18 or older living in the US is eligible, and a diagnosis of PH is NOT required. Study participation is online, and it takes about 20 minutes to complete health surveys and request a saliva collection kit sent through US mail. In return, study participants may opt to receive information about their genetic ancestry at no cost. Type: Observational Start Date: Aug 2025 |
The MIND-BC Study: MIND Diet for Breast Cancer Cognition
H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer
This fully, powered efficacy RCT, the MIND diet for Breast Cancer Cognition (MIND-BC),
will evaluate the MIND diet in a rigorous, highly controlled academic cancer center. We
will recruit breast cancer survivors reporting CRCI with a MIND diet score < 8, based on
a previously devised 14-item diet q1 expand
This fully, powered efficacy RCT, the MIND diet for Breast Cancer Cognition (MIND-BC), will evaluate the MIND diet in a rigorous, highly controlled academic cancer center. We will recruit breast cancer survivors reporting CRCI with a MIND diet score < 8, based on a previously devised 14-item diet questionnaire designed to detect inadequate diet with respect to brain health (scores range from 0 to 14, with lower scores indicating a less adequate diet).14 Breast cancer survivors will have recently completed adjuvant treatment (i.e., 6 months to three years previously), to ensure that perceived cognitive impairment is likely chronic and due to cancer. To achieve maximal effect, the study consists of two 12-week phases 1) intervention phase, 2) maintenance phase. Type: Interventional Start Date: Jul 2025 |
Groceries for Residents of Southeastern USA to Stop Hypertension
Beth Israel Deaconess Medical Center
Hypertension
Elevated Blood Pressure
Cardiovascular Diseases
Dietary Intervention
GoFreshSE is a randomized control trial, testing the effects of a home-delivered,
dietitian-assisted, DASH-patterned grocery intervention on blood pressure in adults with
high blood pressure in Florida, Georgia, and Tennessee. expand
GoFreshSE is a randomized control trial, testing the effects of a home-delivered, dietitian-assisted, DASH-patterned grocery intervention on blood pressure in adults with high blood pressure in Florida, Georgia, and Tennessee. Type: Interventional Start Date: Oct 2025 |
SAGE LEAF 2: An Online Program to Reduce Dementia Caregiver Burden
Northwestern University
Caregiving Stress
Caregiver Burden
The goal of this clinical trial is to learn if the SAGE LEAF (Social Augmentation of
self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers)
online positive emotion skill-building program delivered through Caregiver Serving
Organizations can help family caregivers of1 expand
The goal of this clinical trial is to learn if the SAGE LEAF (Social Augmentation of self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers) online positive emotion skill-building program delivered through Caregiver Serving Organizations can help family caregivers of individuals with dementia cope with stress. The main questions it aims to answer are: - How does SAGE LEAF affect positive emotion, caregiver burden, loneliness, and depression for family caregivers? - What are the challenges and successes when rolling out an online program in partnership with Caregiver Serving Organizations? Participants will complete the 8-week online SAGE LEAF intervention as well as two survey assessments, one before the intervention and one after. Type: Interventional Start Date: Jul 2025 |
Addiction Potential of Very Low Nicotine Filtered Little Cigars
Ohio State University Comprehensive Cancer Center
Smoking (Tobacco) Addiction
The goal of this clinical trial is to learn how reducing the nicotine content in filtered
little cigars can affect the the use of these cigars and lung health in current adult
filtered little cigar users. The main question[s] it aims to answer are:
Are puffing behaviors, appeal/satisfaction, cravi1 expand
The goal of this clinical trial is to learn how reducing the nicotine content in filtered little cigars can affect the the use of these cigars and lung health in current adult filtered little cigar users. The main question[s] it aims to answer are: Are puffing behaviors, appeal/satisfaction, craving suppression, pharmacokinetic effects, and demand similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars? Are health effects and toxicant exposure similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars? Participants will attend three study visits at OSU. Each visit would last up to 4 hours. During visits, they will - fill several surveys - provide blood samples - perform breathing tests - complete smoking sessions using either their own cigars or the study cigars. Type: Interventional Start Date: Feb 2025 |
Registry for Stage 2 Type 1 Diabetes
Sanofi
Type 1 Diabetes
Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but
not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical
T1D), leads to overt hyperglycemia requiring eventually exogenous insulin.
TZIELD® (teplizumab-mzwv) has been approved to de1 expand
Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin. TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D. The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care. Type: Observational Start Date: Sep 2024 |
Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promo1
University of Kansas Medical Center
Multiple Sclerosis
Insomnia
The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I
(tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve
sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection
(Exploratory Aim 3), and to explore the c1 expand
The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions. Type: Interventional Start Date: Oct 2024 |
Living Well With Lymphoma
University of Michigan Rogel Cancer Center
Lymphoma
In this study the investigators are proposing to evaluate the efficacy, sustainability,
and mechanisms of 3 months of individualized counseling of the FRD delivered by
registered dietitians, over 8 sessions by phone/video conferencing on fatigue, quality of
life, and associated symptoms in persiste1 expand
In this study the investigators are proposing to evaluate the efficacy, sustainability, and mechanisms of 3 months of individualized counseling of the FRD delivered by registered dietitians, over 8 sessions by phone/video conferencing on fatigue, quality of life, and associated symptoms in persistently fatigued lymphoma cancer survivors compared to 3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC). The investigators will randomize and follow 68 lymphoma cancer survivors; accounting for a ~10% drop out rate to achieve a target of 60 patients that will complete the study. The investigators hypothesize that persistently fatigued lymphoma cancer survivors will experience improvements in fatigue, quality of life, and symptoms commonly associated with fatigue, which are then maintained at 15-months post-enrollment; and decreased CRP and alterations in inflammation-associated DNA methylation consistent with reduced inflammation from following the FRD as compared to the GHC. Type: Interventional Start Date: Mar 2024 |
Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intest1
Icahn School of Medicine at Mount Sinai
Crohns Disease
Pregnancy
Inflammatory Bowel Disease
The PLANET Study aims to determine the impact of microplastics on intestinal inflammation
and gut microbiome in order to understand the role of this pollutant on the risk of
developing inflammatory bowel disease (IBD) as well as other diseases. With this
information, the researchers hope to charact1 expand
The PLANET Study aims to determine the impact of microplastics on intestinal inflammation and gut microbiome in order to understand the role of this pollutant on the risk of developing inflammatory bowel disease (IBD) as well as other diseases. With this information, the researchers hope to characterize better the role of environmental pollutants on IBD and develop novel strategies towards prevention. Type: Observational Start Date: Aug 2023 |
AWARE: Management of ADHD in Autism Spectrum Disorder
Daniel Coury
ADHD
Autism Spectrum Disorder
This study is a pragmatic clinical trial examining the comparative effectiveness of two
stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in
children and adolescents with autism. Using a sequential, multiple assignment
randomization trial (SMART) design the study will1 expand
This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care. Type: Interventional Start Date: Oct 2023 |
Mixed Methods Study of Health-Related Social Needs in African American Adults With Chronic Kidney D1
Medical College of Wisconsin
Diabetic Nephropathy Type 2 - Uncontrolled
Diabetes Mellitus, Type 2
Chronic Kidney Diseases
The overarching goal of this study is to understand facilitators and barriers to
self-care, develop and refine a culturally tailored intervention to improve clinical
outcomes, quality of life (QOL), and self-care behaviors in African American adults with
diabetic kidney disease (DKD) experiencing h1 expand
The overarching goal of this study is to understand facilitators and barriers to self-care, develop and refine a culturally tailored intervention to improve clinical outcomes, quality of life (QOL), and self-care behaviors in African American adults with diabetic kidney disease (DKD) experiencing health-related social needs (HRSN). Type: Observational Start Date: Jan 2023 |
Mapping and Quantifying Lymphatic Drainage of the Arm's Alternate Pathway
Beth Israel Deaconess Medical Center
Lymphatic System
Using indocyanine green (ICG) lymphography and lymphoscintigraphy with SPECT/CT imaging,
the aim is to evaluate the anatomy of the lymphatic system pathway in two separate
populations: healthy female volunteers and women with a history of breast cancer who did
not develop lymphedema. expand
Using indocyanine green (ICG) lymphography and lymphoscintigraphy with SPECT/CT imaging, the aim is to evaluate the anatomy of the lymphatic system pathway in two separate populations: healthy female volunteers and women with a history of breast cancer who did not develop lymphedema. Type: Observational Start Date: Apr 2022 |
Cognition and Motor Learning Post-stroke
University of Southern California
Stroke
CVA (Cerebrovascular Accident)
This project seeks to determine how post-stroke cognitive impairment moderates motor
learning during walking in older adults with chronic stroke and identify brain structural
markers that mediate this relationship. The chosen experimental design integrates
biomechanical analyses, neuropsychological1 expand
This project seeks to determine how post-stroke cognitive impairment moderates motor learning during walking in older adults with chronic stroke and identify brain structural markers that mediate this relationship. The chosen experimental design integrates biomechanical analyses, neuropsychological assessments, and brain imaging techniques to determine the impact of post-stroke cognitive impairment severity on two forms of motor learning (explicit and implicit) and examine the role of the dorsolateral prefrontal cortex in the relationship between cognition and explicit motor learning. Ultimately, this work may lead to the development of a more comprehensive, effective treatment approach to improve walking dysfunction in older adults post-stroke. Type: Interventional Start Date: Jan 2023 |
Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)
Montefiore Medical Center
Autism Spectrum Disorder
This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children
with ASD. expand
This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD. Type: Interventional Start Date: Apr 2019 |
Understanding Decentralized Trial Engagement and Clinical Impediments Through Digital Efforts (UDEC1
University of Miami
Heart Diseases
The objective of the UDECIDE study is to demonstrate adherence to decentralized clinical
trials among underrepresented groups with cardiometabolic conditions . expand
The objective of the UDECIDE study is to demonstrate adherence to decentralized clinical trials among underrepresented groups with cardiometabolic conditions . Type: Interventional Start Date: Sep 2025 |
Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
Women and Infants Hospital of Rhode Island
Urgency Urinary Incontinence
The goal of this clinical trial is to compare treatment outcomes between an oral
medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency
urinary incontinence (UUI).
Participants will be randomly selected to receive one of the two treatments. The primary
outcome measure1 expand
The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI). Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months. Based on patient expert input, there are 2 primary outcomes: Treatment satisfaction and urinary symptom severity. The study will also have a long-term follow-up component (prospective cohort) including 346 participants from the parent trial to describe treatment continuation, treatment efficacy, patient direct costs and other secondary outcomes up to 5 years after treatment. Type: Interventional Start Date: Jun 2023 |
A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
BioNTech SE
SARS-CoV-2 Virus
Severe Acute Respiratory Syndrome Coronavirus 2
COVID-19
The purpose of this clinical trial is to learn about the safety, extent of the side
effects, and immune responses of the study vaccine (called variant-adapted BNT162b2
RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or
substudies based on age group and prior h1 expand
The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 5 sub-studies will receive study vaccine as a shot depending on what group they are in. - Substudy A design: Phase 1 includes participants 6 months through less than 4 years 3 months of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial series, followed by a fourth dose of study vaccine. Phase 2/3 includes participants 6 months through less than 5 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive 1, 2, or 3 doses of study vaccine, depending on what group they are in. - Substudy B design: includes participants 6 months through less than 5 years of age who have either received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. - Substudy C design: Phase 1 includes participants 6 months through less than 5 years of age who have received 3 prior doses of BNT162b2 and will receive study vaccine as their fourth dose. - Substudy D design: includes participants 5 through less than12 years of age who have received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. - Substudy E design: includes participants 5 through less than 12 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive a single dose of study vaccine. Type: Interventional Start Date: Sep 2022 |
Low-dose Buprenorphine Initiation for Opioid Use Disorder
Montefiore Medical Center
Opioid Use Disorder
The purpose of this study is to test whether low-dose buprenorphine initiation for
treatment of opioid use disorder is safe and effective. expand
The purpose of this study is to test whether low-dose buprenorphine initiation for treatment of opioid use disorder is safe and effective. Type: Interventional Start Date: Nov 2024 |
Assessment of the Ocular Microbiome in Health and Disease
Vanderbilt University Medical Center
Microbial Colonization
Eye Diseases
Ophthalmopathy
The objective of this application is to illustrate the core constituents of the ocular
surface microbiome, describe factors that promote colonization, and assess the ocular
microbiome's role in the health of the anterior segment. We will conduct a prospective,
observational cohort study, including1 expand
The objective of this application is to illustrate the core constituents of the ocular surface microbiome, describe factors that promote colonization, and assess the ocular microbiome's role in the health of the anterior segment. We will conduct a prospective, observational cohort study, including a longitudinal analysis of the ocular microbiome in adults. Type: Observational Start Date: Sep 2023 |
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Massachusetts General Hospital
Gout
The TRUST study is a randomized, controlled multicenter study to evaluate the management
of gout by comparing two commonly used treatment strategies for gout (TTT vs TTASx) to
determine the most beneficial for a patient-centered gout outcomes, as well as relevant
cardiovascular-metabolic-renal endp1 expand
The TRUST study is a randomized, controlled multicenter study to evaluate the management of gout by comparing two commonly used treatment strategies for gout (TTT vs TTASx) to determine the most beneficial for a patient-centered gout outcomes, as well as relevant cardiovascular-metabolic-renal endpoints. Type: Interventional Start Date: Feb 2024 |
Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy
Joshua M Hare
Non-ischemic Dilated Cardiomyopathy
The purpose of this study is to evaluate the safety and effectiveness of an experimental
drug called human allogeneic mesenchymal stem cell therapy. expand
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy. Type: Interventional Start Date: May 2021 |
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
Vanderbilt University Medical Center
Tremor
Essential Tremor
Parkinson Disease
Radiosurgery
Quality of Life
The purpose of this study is to determine the changes in quality of life and degree of
tremor for patients with essential tremor or Parkinsonian tremor who are treated by
stereotactic radiosurgery (SRS). This is a questionnaire-based study. Please see Detailed
Description below for more information. expand
The purpose of this study is to determine the changes in quality of life and degree of tremor for patients with essential tremor or Parkinsonian tremor who are treated by stereotactic radiosurgery (SRS). This is a questionnaire-based study. Please see Detailed Description below for more information. Type: Observational Start Date: Feb 2013 |
Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids
Wayne State University
Adolescence
Anxiety disorders commonly begin during adolescence, and are characterized by deficits in
the ability to inhibit or extinguish pathological fear. Recent research has provided new
understanding of how fear is learned and can be regulated in the adolescent brain, and
how the endocannabinoid system sh1 expand
Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth. Type: Interventional Start Date: May 2024 |

