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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 |
A Study of JNJ-55308942 in the Treatment of Bipolar Depression
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 |
The Electronic Medical Records and GEnomics (eMERGE) Network Genomic Risk Assessment
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 |
Improving Thinking in Everyday Life After Covid-19
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 |
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.... 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. Type: Interventional Start Date: Jun 2023 |
AIM's Writing for Healing: A Workshop for Individuals Living With Paralysis
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...
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 |
Acceptance and Commitment Therapy for Depressed Individuals Living With Spinal Cord Injury Sustained...
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 |
Doravirine for Persons With Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide
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 |
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
University of Alabama at Birmingham
Stroke
Cognitive Dysfunction
This study will compare two approaches to cognitive rehabilitation in adults with stroke with
persistent, mild to moderate, cognitive impairment. Both approaches will feature a web-based
computer "game" that trains cognitive processing speed, i.e., how quickly individuals process... expand
This study will compare two approaches to cognitive rehabilitation in adults with stroke with persistent, mild to moderate, cognitive impairment. Both approaches will feature a web-based computer "game" that trains cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. This training is termed Speed of Processing Training (SOPT). One approach will add (A) in-lab training on everyday activities with important cognitive components and (B) procedures designed to transfer improvements in cognition from the treatment setting to everyday life. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will add (A) in-lab training on relaxation, healthy nutrition, and healthy sleep and (B) procedures designed to promote integration of these lifestyle changes into everyday life. This approach is termed Brain Fitness-Heath Education Lifestyle Program (BF-HELP). Both CICT and BF-HELP will involve 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life; The set of the latter procedures is termed the Transfer Package. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. Family caregivers in both groups will also receive training on how to best support participants in their therapeutic program. The study will also test if there is an advantage to placing follow-up phone calls after treatment ends. The purpose of the calls will be to support transition of any behavioral changes achieved during treatment into everyday life on a long-term basis. Participants will be randomly assigned to the interventions. Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6- and 12-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life. Type: Interventional Start Date: Jun 2022 |
Pain Relief for OsteoArthritis Through Combined Treatment (PROACT)
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
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 |
Immunization With BCG Vaccine to Prevent Tuberculosis Infection
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 |
Optimizing Protein Patterns for Skeletal Muscle Preservation and Sleep in the Medical Management of Parkinson...
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 |
NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
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 |
American Lung Association (ALA) Lung Health Cohort
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 |
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis
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
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 |
PRECISION-BP: Precision Chronopharamacotherapy Targeting NP-RAAS-BP Rhythm Axis
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 |
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial
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 |
Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
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 |
Gut Oxalate Absorption in Calcium Oxalate Stone Disease
University of Alabama at Birmingham
Kidney Stone
Kidney Calculi
Urolithiasis
Urolithiasis, Calcium Oxalate
Nephrolithiasis
The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate
kidney stones have an increased absorption of dietary oxalate, which would lead to increased
urinary excretion of oxalate.
The study will recruit adult patients with a history of... expand
The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased absorption of dietary oxalate, which would lead to increased urinary excretion of oxalate. The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones. Participants will - ingest fixed diets containing low and moderately high amounts of oxalate for 5 days at a time - ingest a soluble form of oxalate and sugar preparations to test gut permeability - collect urine, blood, stool and breath sample during the fixed diets and the soluble oxalate test Type: Interventional Start Date: May 2024 |
O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease
University of Alabama at Birmingham
Kidney Stone
Kidney Calculi
Urolithiasis
Urolithiasis, Calcium Oxalate
Nephrolithiasis
The goal of this trial is to test if colonization with the gut bacteria Oxalobacter
formigenes leads to a reduction in urinary oxalate excretion in patients with calcium oxalate
kidney stone disease.
The study will recruit adult participants with a history of calcium oxalate... expand
The goal of this trial is to test if colonization with the gut bacteria Oxalobacter formigenes leads to a reduction in urinary oxalate excretion in patients with calcium oxalate kidney stone disease. The study will recruit adult participants with a history of calcium oxalate kidney stones who are not colonized with Oxalobacter formigenes. Participants will - ingest fixed diets containing low and moderately high amounts of oxalate for 4 days at a time - collect urine, blood and stool samples during the fixed diets - ingest a preparation of live Oxalobacter formigenes to induce colonization with Oxalobacter formigenes Type: Interventional Start Date: May 2024 |
Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation
University of Alabama at Birmingham
Parathyroid Dysfunction
Adenoma
The aim of this study is to determine if fluorescence with or without indocyanine green can
facilitate safe and accurate thyroid and parathyroid surgery.
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The aim of this study is to determine if fluorescence with or without indocyanine green can facilitate safe and accurate thyroid and parathyroid surgery. Type: Interventional Start Date: Apr 2024 |
Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart...
Bristol-Myers Squibb
Heart Failure
The purpose of this study is to evaluate the safety, tolerability, and exposure-response
(E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved
Ejection Fraction (HFpEF).
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The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF). Type: Interventional Start Date: Nov 2023 |