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A Study of JNJ-55308942 in the Treatment of Bipolar Depression
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Janssen Pharmaceutica N.V., Belgium
Bipolar Disorder
The purpose of this study is to evaluate the efficacy of JNJ-55308942 compared to placebo on
symptoms of depression in participants with bipolar disorder (BD) in a major depressive
episode (MDE) at Week 6.
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The purpose of this study is to evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorder (BD) in a major depressive episode (MDE) at Week 6. Type: Interventional Start Date: Jun 2022 |
A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation...
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Bristol-Myers Squibb
Heart Failure With Preserved Ejection Fraction
This is a Phase 2a proof-of-concept study to assess safety, tolerability, and preliminary
efficacy of mavacamten treatment on biomarker levels in participants with heart failure with
preserved ejection fraction (HFpEF) and elevation of NT-proBNP with or without elevation of... expand
This is a Phase 2a proof-of-concept study to assess safety, tolerability, and preliminary efficacy of mavacamten treatment on biomarker levels in participants with heart failure with preserved ejection fraction (HFpEF) and elevation of NT-proBNP with or without elevation of cTnT. Data from this study will inform future study designs of mavacamten in patients with HFpEF. Type: Interventional Start Date: Mar 2021 |
Feasibility of the First Known Adaptive Intervention for People With SCI
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University of Alabama at Birmingham
Spinal Cord Injuries
The overall goal of the proposed research is to conduct a pilot study to test the feasibility
and acceptability of a home-based exercise intervention (SMART-HEALTH). The primary purpose
of the pilot study is to assess the feasibility of intervention delivery (Aim 1), the
acceptability... expand
The overall goal of the proposed research is to conduct a pilot study to test the feasibility and acceptability of a home-based exercise intervention (SMART-HEALTH). The primary purpose of the pilot study is to assess the feasibility of intervention delivery (Aim 1), the acceptability of the intervention by participants (Aim 2) and estimate effect sizes for a future trial (Aim 3). Type: Interventional Start Date: Jun 2022 |
AIM's Writing for Healing: A Workshop for Individuals Living With Paralysis
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University of Alabama at Birmingham
Spinal Cord Injuries
The UAB Institute for Arts In Medicine (AIM) is currently implementing an expressive
emotional writing pilot project for adults with paralysis caused by neurological conditions
such as traumatic head or spinal cord injury.
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The UAB Institute for Arts In Medicine (AIM) is currently implementing an expressive emotional writing pilot project for adults with paralysis caused by neurological conditions such as traumatic head or spinal cord injury. Type: Observational Start Date: Sep 2020 |
The Electronic Medical Records and GEnomics (eMERGE) Network Genomic Risk Assessment
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Vanderbilt University Medical Center
Genetic Disease
The eMERGE Network embraces the opportunity to use new methods in genomic medicine,
information science, and research participant engagement to identify people at very high risk
for specific diseases and recommend individualized approaches to prevention and care. The
investigators... expand
The eMERGE Network embraces the opportunity to use new methods in genomic medicine, information science, and research participant engagement to identify people at very high risk for specific diseases and recommend individualized approaches to prevention and care. The investigators will conduct a prospective study, with diverse and underserved participants, across ten eMERGE study sites to evaluate clinical implementation of a Genome Informed Risk Assessment (GIRA) tool that combines genetic, family history, and clinical risk information from participants. Type: Interventional Start Date: Feb 2022 |
A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
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Reata Pharmaceuticals, Inc.
Autosomal Dominant Polycystic Kidney
ADPKD
This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial
will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients
with ADPKD. Approximately 850 patients will be enrolled.
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This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 850 patients will be enrolled. Type: Interventional Start Date: May 2019 |
Improving Thinking in Everyday Life After Covid-19
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University of Alabama at Birmingham
Covid-19
Cognitive Impairment
The purpose of this initial study is to evaluate a new form of cognitive rehabilitation
therapy for improving your ability to think, particularly how rapidly you process information
that you receive from your senses, e.g., sight, hearing, and smell. The study will also test... expand
The purpose of this initial study is to evaluate a new form of cognitive rehabilitation therapy for improving your ability to think, particularly how rapidly you process information that you receive from your senses, e.g., sight, hearing, and smell. The study will also test how often and how well you carry out tasks that rely on thinking in your daily life. You will be randomly assigned to receive the new therapy soon or about three months later. In other words, your treatment schedule will be determined by chance. The new therapy involves intensive, repetitive cognitive exercises (up to 3.5hr/day for 10 consecutive weekdays) with rest periods interspersed as needed. Type: Interventional Start Date: Nov 2020 |
A Ten-Week Online Acceptance and Commitment Therapy Intervention for Family Caregivers of People With...
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University of Alabama at Birmingham
Psychological Distress
The randomized controlled trial aims to assess effects of a coach-guided ten-week online
acceptance and commitment therapy (ACT) intervention on distressed family caregivers of
people with dementia (PwD) compared to the control group. A total of 64 family caregivers of
PwD... expand
The randomized controlled trial aims to assess effects of a coach-guided ten-week online acceptance and commitment therapy (ACT) intervention on distressed family caregivers of people with dementia (PwD) compared to the control group. A total of 64 family caregivers of PwD who meet the inclusion criteria will be recruited and randomized to either the intervention group or the control group. Exploratory hypotheses are that the ACT group will show decreases in caregivers' psychological distress and burden and improvements in psychological quality of life and engagement in meaningful activities at posttest and 3-month follow-up, compared to the control group. Type: Interventional Start Date: Mar 2022 |
Acceptance and Commitment Therapy for Depressed Individuals Living With Spinal Cord Injury Sustained...
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University of Alabama at Birmingham
Depression
Spinal Cord Injuries
This randomized controlled trial aims to assess effects of videoconferencing acceptance and
commitment therapy (ACT) on mental health outcomes in individuals living with spinal cord
injuries (SCI). A total of 40 individuals living with SCI sustained within 5 years and
experiencing... expand
This randomized controlled trial aims to assess effects of videoconferencing acceptance and commitment therapy (ACT) on mental health outcomes in individuals living with spinal cord injuries (SCI). A total of 40 individuals living with SCI sustained within 5 years and experiencing depressive symptoms will be recruited and randomly assigned to either the ACT group or the wait-list control group. The ACT group will receive 8 weekly individual ACT sessions guided by a coach through videoconferencing. The wait-list group will receive ACT sessions after the study period ends. We will provide psychoeducation materials related to SCI as supplemental resources to both groups. Mental health outcomes using self-reported questionnaires will be collected at pretest, posttest, and 2-month follow-up. Exploratory hypotheses are that the group undergoing the ACT intervention supplemented with psychoeducation will show improvements in mental health outcomes (e.g., depression) and ACT processes (e.g., psychological flexibility) at posttest and 2-month follow-up, compared to the wait-list control group provided with psychoeducation materials alone. Interviews will be conducted at posttest to explore the participants' experiences in ACT. Type: Interventional Start Date: Mar 2023 |
Circadian Mechanisms Underlying Non-Dipping Blood Pressure in Blacks
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University of Alabama at Birmingham
Circadian Rhythm
Blood Pressure
This study seeks to examine central and peripheral circadian mechanisms in Blacks with
appropriately dipping systolic blood pressure (blood pressure that dips by at least 10%)
compared with non-dipping systolic blood pressure (blood pressure that dips by less than 10%)
using... expand
This study seeks to examine central and peripheral circadian mechanisms in Blacks with appropriately dipping systolic blood pressure (blood pressure that dips by at least 10%) compared with non-dipping systolic blood pressure (blood pressure that dips by less than 10%) using a constant routine protocol. Constant routine protocols are commonly used in the field of circadian biology to examine rhythms in biological processes while controlling the entraining effects of light, activity, and diet. Type: Interventional Start Date: Jan 2020 |
Transcranial Direct Current Stimulation for Post-stroke Motor Recovery
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Duke University
Stroke, Ischemic
Motor Activity
Upper Extremity Paralysis
This research study is to find out if brain stimulation at different dosage level combined
with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation
technique is called transcranial direct current stimulation (tDCS). The treatment uses direct... expand
This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one. Type: Interventional Start Date: Sep 2019 |
Using Interactive Virtual Presence to Remotely Assist Parents With Child Restraint Installations
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University of Alabama at Birmingham
Car Seat Installation
Motor vehicle crashes cause the death of an American child every 3 hours, more than any other
cause. When installed correctly, car seats reduce risk of serious injury and death to infants
and young children. Unfortunately, a large portion of child restraints is installed
incorrectly.... expand
Motor vehicle crashes cause the death of an American child every 3 hours, more than any other cause. When installed correctly, car seats reduce risk of serious injury and death to infants and young children. Unfortunately, a large portion of child restraints is installed incorrectly. A network of trained technicians work across the country to assist parents in achieving correct use of child restraints through scheduled "car seat checks," where technicians work with parents to install restraints in their vehicles. Car seat checks are effective in reducing errors in child restraint installations. However, the services are highly underutilized. The present study evaluates use of interactive virtual presence technology (also called interactive merged reality) to remotely assist parents to install child restraints correctly into their vehicles. Building from small pilot studies on the topic, the investigators will conduct a randomized non-inferiority trial to evaluate whether parents who install child restraints while communicating with a remote expert technician via interactive virtual presence achieve installations and learning that are not inferior in their safety to parents who install restraints live with a remote technician onsite. The investigators will recruit 1476 parents at 7 locations nationwide and randomly assign consenting parents to install their child restraint either via interactive virtual presence or with a live technician. The correctness of installation safety will be assessed using objective checklists, both following installation and again four months later. The investigators aim to demonstrate that child restraint installation is accurate (>90% correct) when conducted remotely via interactive virtual presence, that such installations are not inferior to the accuracy of installation with a live on-site expert, and that parents learn and retain information about correct child restraint installation. Type: Interventional Start Date: Jan 2020 |
Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)
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University of Florida
Osteoarthritis of Knee
This mechanistic clinical trial proposes to test whether a five-day course of mindfulness
meditation training (MMT) and tDCS, and their combination, can enhance pain modulatory
balance and pain-related brain function, reduce clinical pain, among African Americans and
non-Hispanic... expand
This mechanistic clinical trial proposes to test whether a five-day course of mindfulness meditation training (MMT) and tDCS, and their combination, can enhance pain modulatory balance and pain-related brain function, reduce clinical pain, among African Americans and non-Hispanic whites with knee osteoarthritis (OA). This approach will provide evidence that targeting stress and pain-related brain function will reduce OA-related pain and ethnic group differences therein. Type: Interventional Start Date: Mar 2020 |
Doravirine for Persons With Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide
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AIDS Clinical Trials Group
HIV Infections
The primary purpose of this study is to see if people with HIV who had a significant weight
gain after starting INSTI (integrase strand transfer inhibitor)+TAF/FTC (tenofovir
alafenamide/emtricitabine) (TAF/3TC (lamivudine)) regimen could either slow their rate of
weight gain... expand
The primary purpose of this study is to see if people with HIV who had a significant weight gain after starting INSTI (integrase strand transfer inhibitor)+TAF/FTC (tenofovir alafenamide/emtricitabine) (TAF/3TC (lamivudine)) regimen could either slow their rate of weight gain or lose weight within about 1 year if they switch to a regimen containing doravirine (DOR; a newer, non-nucleoside reverse transcriptase inhibitor medication). The study will also try to see if participants changing from TAF/FTC (or TAF/3TC) to TDF/FTC (or TDF/3TC) will experience less additional weight gain or a reduction in overall body weight at 48 weeks compared to persons continued on an INSTI + TAF/FTC (or TAF/3TC) combination. INSTINs assessed in A5391 include bictegravir (BIC), dolutegravir (DTG), or raltegravir (RAL). Additionally, the study will see whether a change in ART can affect things like waist circumference, metabolic and cardiovascular health, fat and lean mass body composition, bone health, and maintenance of virologic suppression. Finally, the study will look at the safety and tolerability of DOR plus either TAF/FTC (or TAF/3TC) versus TDF/FTC (or TDF/3TC). Type: Interventional Start Date: May 2021 |
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial
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Joseph Broderick, MD
Intracerebral Hemorrhage
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... expand
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 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. Type: Interventional Start Date: Dec 2021 |
PRECISION-BP: Precision Chronopharamacotherapy Targeting NP-RAAS-BP Rhythm Axis
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University of Alabama at Birmingham
Obesity
Cardiovascular Diseases
Hypertension
Nocturnal Blood Pressure
Natriuretic Peptides
Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping blood
pressure (BP). These conditions are associated with an increased risk of cardiovascular (CV)
events and death. Natriuretic Peptides (NPs) are hormones produced by the heart which
directly... expand
Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping blood pressure (BP). These conditions are associated with an increased risk of cardiovascular (CV) events and death. Natriuretic Peptides (NPs) are hormones produced by the heart which directly regulate BP by causing dilation of blood vessels and by removing sodium and water from the body. NPs have a 24-hour day-night rhythm and this controls the day-night rhythm of BP as well. The NP-BP rhythm relationship is broken down in obese individuals. Obese individuals also have lower circulating NP levels. Lower circulating levels of NPs and elevated renin hormone (a part of the Renin-Angiotensin-Aldosterone System [RAAS]) at nighttime may contribute to the high nocturnal blood pressure in obese individuals which puts them at a higher risk of developing CV events. This current study seeks to determine the biological implications of chronopharmacology for synchronizing NP-RAAS-based blood pressure therapy with the physiological diurnal rhythms to restore the normal diurnal rhythm of blood pressure in obese individuals. Type: Interventional Start Date: Feb 2022 |
Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
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Duke University
Cognitive Impairment, Mild
Dementia
Cardiovascular Diseases
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority
study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study
conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia... expand
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events. Type: Interventional Start Date: Sep 2020 |
Race, Natriuretic Peptides and Physiological Perturbations
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University of Alabama at Birmingham
Healthy
Pre Hypertension
The purpose of the study is to understand the origins of differential response to
beta-blockers in African-Americans and may provide insight regarding racial differences in
cardiovascular risk.
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The purpose of the study is to understand the origins of differential response to beta-blockers in African-Americans and may provide insight regarding racial differences in cardiovascular risk. Type: Interventional Start Date: Apr 2017 |
Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
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Gilead Sciences
Pre-Exposure Prophylaxis of HIV Infection
The goal of this clinical study is to test how well the study drug, lenacapavir (LEN), works
in preventing the risk of HIV.
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The goal of this clinical study is to test how well the study drug, lenacapavir (LEN), works in preventing the risk of HIV. Type: Interventional Start Date: Jun 2021 |
Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity
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University of Alabama at Birmingham
CVA (Cerebrovascular Accident)
Stroke
Upper Extremity Paresis
CI therapy is a family of techniques that has systematically applied intensive treatment
daily over consecutive days, supervised motor training using a technique called shaping,
behavioral strategies to improve the use of the more- affected limb in real life situations
called... expand
CI therapy is a family of techniques that has systematically applied intensive treatment daily over consecutive days, supervised motor training using a technique called shaping, behavioral strategies to improve the use of the more- affected limb in real life situations called a Transfer Package (TP), and strategies to remind participants to use the more-affected extremity; including restraint of the less-affected arm in the upper extremity (UE) protocol. Numerous studies examining use of CI therapy with UE rehabilitation have demonstrated robust evidence for increasing the amount and the quality of the paretic UE functional use in daily situations of individuals recovering from stroke. Previous studies have explored the barriers for clinical implementation of the approach, including the amount of time needed by therapists, other resources required and lack of payment for the services. With regards to therapists' time/resources, in the signature CI therapy protocol, therapists supervised movement training for 3 hours daily (except for weekends) for a 12 consecutive-day period. This level of supervision in highly unusual for traditional rehabilitation clinical settings. The treatment schedule is also incompatible with most insurance reimbursement policies in the US. As such, most CI therapy clinics require patients to pay privately with little or no insurance reimbursement. Such practices severely limit the number of patients who can afford to receive CI therapy. Two lines of evidence have suggested that an alternative CI therapy protocol may allow for the essential (or "Key") CI therapy elements to be delivered in a schedule that better utilizes therapist time/resources and is compatible with payment policies of many US insurance companies. One line of evidence comes from findings that indicate that the original 6-hour supervised training schedule could be shortened to as little as 2-hours/daily without a reduction in outcomes. Additional evidence comes from a study exploring the systematic addition and deletion of the signature CI therapy protocol elements indicated that when the transfer package was omitted, outcomes related to functional use were reduced by 50%. These findings were also verified by brain imaging studies conducted concurrently that revealed a much-reduced level of brain remodeling in those not receiving the transfer package. These findings highlight the potential effectiveness of the transfer package and continued movement training by the patient while away from clinical supervision. The hypothesis of this study is that the amount of supervised training could be reduced further and delivered in a distributed schedule (1 to 4 times/ week over an 8-week period) instead of consecutively over a 12-day treatment period. This modification could be possible by adapting and strengthening the transfer package component of the protocol. In order to investigate if all of the Keys intervention protocol is necessary for producing optimal outcomes, the delivery of specific protocol elements will be also explored. Additionally, another round of testing at the 4-week point of the 8-week intervention will be administered to investigate the need for the final 4 weeks of the intervention. Type: Interventional Start Date: Apr 2022 |
American Lung Association (ALA) Lung Health Cohort
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Johns Hopkins University
Lung Diseases
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000
young adults between the ages of 25-35 who do not have severe lung disease. The overarching
objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of... expand
The ALA-LHC is a longitudinal, multi-center cohort study that will enroll approximately 4,000 young adults between the ages of 25-35 who do not have severe lung disease. The overarching objective of the ALA-LHC is to establish a national cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages. Type: Observational Start Date: Oct 2021 |
Accessible and Inclusive Diabetes Telecoaching Self-Management Program
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University of Alabama at Birmingham
Diabete Type 2
Disability Physical
The purpose of this study is to develop and pilot test an accessible and inclusive Artificial
Intelligence (AI)-assisted, individualized, family-focused lifestyle modification
intervention (AI4DM) for glycemic control in people with disabilities.
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The purpose of this study is to develop and pilot test an accessible and inclusive Artificial Intelligence (AI)-assisted, individualized, family-focused lifestyle modification intervention (AI4DM) for glycemic control in people with disabilities. Type: Interventional Start Date: Oct 2022 |
NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
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University of Alabama at Birmingham
Diabetes Mellitus
Cardiovascular Diseases
Insulin Sensitivity/Resistance
Metabolic Disease
Natriuretic Peptides
Black individuals are more likely to have decreased insulin sensitivity which results in a
high risk for the development of cardiometabolic disease. The reasons for this are
incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart that
play a... expand
Black individuals are more likely to have decreased insulin sensitivity which results in a high risk for the development of cardiometabolic disease. The reasons for this are incompletely understood. Natriuretic peptides (NPs) are hormones produced by the heart that play a role in regulating the metabolic health of an individual. Low circulating level of NPs is an important contributor to increased risk for diabetes. The NP levels are relatively lower among Black individuals thus affecting their metabolic health and putting them at a higher risk for diabetes. This study aims to test the hypothesis that by augmenting NP levels using sacubitril/valsartan, among Black Individuals one can improve their metabolic health (as measured by insulin sensitivity & energy expenditure) and help establish the role of NPs in the underlying mechanism behind increased risk for cardiometabolic disease in these population. Type: Interventional Start Date: Aug 2020 |
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis
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Zydus Therapeutics Inc.
Nonalcoholic Steatohepatitis
Fibrosis
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis
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Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis Type: Interventional Start Date: Aug 2021 |
Optimizing Protein Patterns for Skeletal Muscle Preservation and Sleep in the Medical Management of Parkinson...
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University of Alabama at Birmingham
Parkinson Disease
The purpose of this pilot study is to generate preliminary data on the impact of the dietary
protein pattern on markers of skeletal muscle health and drug efficacy in Parkinson disease.
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The purpose of this pilot study is to generate preliminary data on the impact of the dietary protein pattern on markers of skeletal muscle health and drug efficacy in Parkinson disease. Type: Interventional Start Date: Oct 2022 |