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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 |
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 |
AIM's Writing for Healing: A Workshop for Individuals Living With Paralysis
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University of Alabama at Birmingham
Spinal Cord Injuries
Multiple Sclerosis
Transverse Myelitis
Amyotrophic Lateral Sclerosis
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 |
A Ten-Week Online Acceptance and Commitment Therapy Intervention for Family Caregivers of People With...
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University of Alabama at Birmingham
Depressive Symptoms
This randomized controlled trial aims to assess the effects of a coach-guided ten-week
videoconferencing acceptance and commitment therapy (ACT) program on mental health outcomes
in depressed family caregivers of people with dementia (PwD) compared to the control group. A... expand
This randomized controlled trial aims to assess the effects of a coach-guided ten-week videoconferencing acceptance and commitment therapy (ACT) program on mental health outcomes in depressed family caregivers of people with dementia (PwD) compared to the control group. A total of 64 family caregivers of PwD who meet the eligibility criteria will be recruited and randomized to either the intervention group or the control group. The hypotheses are that the ACT group will show improvements in depressive symptoms, other mental health outcomes, and ACT process measures at posttest and 3-month follow-up, compared to the control group. Type: Interventional Start Date: Mar 2022 |
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 |
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 |
Low-GI Diet vs High-GI Diet in Individuals With SCI
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Ohio State University
Spinal Cord Injuries
Postprandial Hypotension
Glucose Metabolism Disorders
The purpose of this pilot research project is to examine the impact of a low-glycemic index
(GI) diet on postprandial hypotension and glucose control in individuals with chronic spinal
cord injury. The objectives are: 1) To evaluate the effect of the low-GI diet on the
magnitude... expand
The purpose of this pilot research project is to examine the impact of a low-glycemic index (GI) diet on postprandial hypotension and glucose control in individuals with chronic spinal cord injury. The objectives are: 1) To evaluate the effect of the low-GI diet on the magnitude of postprandial systolic blood pressure drop compared to a high-GI control diet. 2)To evaluate the effect of a low-GI diet on postprandial glucose and insulin responses compared to a high-GI control diet. Type: Interventional Start Date: May 2022 |
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 |
Immunization With BCG Vaccine to Prevent Tuberculosis Infection
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Henry M. Jackson Foundation for the Advancement of Military Medicine
Tuberculosis Infection
The purpose of this research is to find out if a single dose of pre-travel vaccination with
BCG can lessen tuberculosis (TB) infection by producing an immune response when given to
adults traveling to countries with a high burden of TB. BCG will be compared with a placebo... expand
The purpose of this research is to find out if a single dose of pre-travel vaccination with BCG can lessen tuberculosis (TB) infection by producing an immune response when given to adults traveling to countries with a high burden of TB. BCG will be compared with a placebo (an inactive vaccine). BCG (Japan) is used globally but is not approved for use in the United States, therefore it is considered experimental. Participants choosing to take part in this research study, will be randomly assigned (this is like a coin flip) to BCG or placebo. 2000 eligible volunteers will be enrolled. Type: Interventional Start Date: Dec 2021 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and...
Takeda
Alpha1-Antitrypsin Deficiency
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis)
compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening
in the liver, to get information on how fazirsiran affects the body (called
pharmacodynamics),... expand
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo. Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study. Type: Interventional 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).
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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 |
Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis
University of Alabama at Birmingham
Amyotrophic Lateral Sclerosis
The aim of this study is to understand how well a 6-week virtual yogic breathing exercise
program (YBEP) will improve breathing, speech, and emotional well-being in people with
amyotrophic lateral sclerosis (ALS).
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The aim of this study is to understand how well a 6-week virtual yogic breathing exercise program (YBEP) will improve breathing, speech, and emotional well-being in people with amyotrophic lateral sclerosis (ALS). Type: Interventional Start Date: Nov 2023 |
Cold Agglutinin Disease Real World Evidence Registry
Sanofi
Cold Agglutinin Disease (CAD)
Cold Agglutinin Syndrome (CAS)
This is a multinational, multi-center, observational, prospective, longitudinal disease
registry designed to collect data on participants with cold agglutinin disease (CAD) or cold
agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with
sutimlimab... expand
This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 [NCT02502903,CAD patients], BIVV009-03/EFC16215 [NCT03347396], and BIVV009-04/EFC16216 [NCT03347422]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry. Type: Observational [Patient Registry] Start Date: Dec 2019 |
A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin...
Amgen
Atopic Dermatitis
The coprimary objectives of the study are to:
- evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or
topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with
TCS/TCI at Week 24, assessed using Validated... expand
The coprimary objectives of the study are to: - evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™). - evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI). Type: Interventional Start Date: Feb 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... 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 2 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 |