Trials Today

The purpose of this study is to test the effect of virtual reality (VR) food marketing exposure (versus VR non-food control) on snack consumption, purchase intention, hunger, and arousal in black and white young adults. Participants will be randomized to either the VR food marketing condition or VR non-food control. Study participation duration will be 2 hours during a one-time, single visit.

Type: Interventional

Start Date: Nov 2025

open study

The purpose of this study is to find out what combination of components, if any, offers the best support for keeping weight off after someone loses weight. Long term weight loss maintenance is a challenge for many people who lose weight. There are many strategies, or components, people may use to avoid regain, but investigators do not know if there is a best, or optimal, combination of such components that can be done without adding a lot of cost or other burdens for people. - The primary goal of this clinical trial is to identify the optimal package that maximizes weight loss maintenance. - The study also wants to understand the reasons why these components may work and if certain components help specific sub-groups of people. Participants will engage in a 16-week Phase 1 Weight Loss Program. Participants who lose 5% or more of their weight during that program will continue to Phase 2 Extended Care and be randomly assigned to 0, 1, 2, 3, or all of four methods of weight loss maintenance. They will use their assigned package for 12 months. Researchers will compare 16 different possible combinations of components and learn which of the 16 packages offers the best support for keeping weight off. The four components participants could be assigned to in Phase 2 are: 1. Reduced Food Variety: Limiting the variety of foods participants eat by having them choose a few high-calorie, low nutrient foods to eat regularly 2. Home-based Resistance Training: Engaging in exercises that build strength from the comfort of the participant's own home 3. Buddy Training and Support: Having a friend or "buddy" get trained to support the participant 4. Acceptance and Commitment (ACT) Workshops: Having participants learn skills to handle tough thoughts and feelings about weight control in a healthy way Participants will have their weight measured and complete surveys 4 times if they complete both Phase 1 and Phase 2. During Phase 1, participants will attend weekly group sessions and be in touch with a study staff member investigators call a Wellness Coach. During Phase 2, participants will stay in touch with their Wellness Coach, use their assigned package, and answer questions about their experience periodically.

Type: Interventional

Start Date: Dec 2025

open study

The investigators will conduct a 2-arm 6-month randomized clinical controlled trial to evaluate the effectiveness of an oral Telehealth Intervention (THI) in preventing cancer-related oral complications, improving oral health maintenance and oral health related quality of life, and reducing systemic inflammation compared to Usual Care (UC) among unselected cancer survivors.

Type: Interventional

Start Date: Aug 2024

open study

The goal of this clinical trial is to see if 12 sessions of a Parent Management Training program can treat irritability in children aged 10-14 years old. The main question it aims to answer are: - Can a Parent Management Training for parents reduce anger outbursts and cranky moods in their children? - Can Parent Management Training be done in an outpatient clinic and do parents like it? Up to 18 families can join this study. This study will be used to set up a larger study in the Fall of 2025. Parent participants will complete 12 sessions of Parent Management Training for Irritability. Each session will be 45-55 minutes weekly. They will also participate in the assessments of their child before, during and after treatment. Child participants will do assessments before, during and after the Parent Management Training treatment.

Type: Interventional

Start Date: Jun 2025

open study

This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial). The study contains of 5 arms: NYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data. - Treatment Arm (Group 1) - Active Control Arm (Group 2) - Crossover Arm (Group 3) NYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy.

Type: Interventional

Start Date: Nov 2023

open study

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from F8 coil or active rTMS from H coil for smoking cessation. Smoking and brain functional connectivity changes will be assessed at baseline, different stages of rTMS and/or follow-ups.

Type: Interventional

Start Date: Jun 2022

open study

This study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of weight monitoring and physical activity in adults with heart failure (HF). Half of the participants will receive the SCDG app and weight monitoring and physical activity sensors and the other half will receive only the weight monitoring and physical activity sensors.

Type: Interventional

Start Date: Nov 2022

open study

The primary goal of this project is to describe the clinical and physiologic characteristics of Spontaneous Coronary Artery Dissections (SCAD) in order to increase awareness, understanding, treatment and prevention of a potentially fatal cardiovascular event. This study will be a retrospective and prospective review of medical course and current health of men and women with SCAD.

Type: Observational

Start Date: Jul 2011

open study

Background: Most drugs that treat mood disorders take a long time to work. Ketamine works within hours. A dose can last for a week or more. Certain receptors in the brain might help ketamine work. A drug that blocks these receptors might affect how it works. Objective: To see if the antidepressant response of ketamine is linked to AMPA receptors. Eligibility: Adults ages 18-70 with major depression disorder without psychotic features Design: Participants will be screened under protocol 01-M-0254. They will have blood tests and a physical exam. Participants will stay at the NIH Clinical Center for 5 weeks. Phase 1 lasts 4 weeks. For 2 weeks, participants will taper off their psychiatric medicine. Then they will have the following tests: - Blood draws - Psychological tests - MRI: Participants will lie in a machine that takes pictures of their brain. - MEG: Participants will lie down and do tasks. A cone lowered on their head will record brain activity. - Optional sleep tests: Electrodes on the scalp and body and belts around the body will monitor participants while they sleep. - Optional TMS: Participants will do tasks while a wire coil is held on their scalp. An electrical current will pass through the coil that affects brain activity. For phase 2, on day 0 participants will take the study drug or a placebo orally. While having a MEG, they will get ketamine infused into a vein in one arm while blood is drawn from a vein in the other arm. On day 1, participants will again take the study drug or a placebo orally. On days 3-7, they will repeat many of the phase 1 tests. Days 8 and 9 are optional and include an open label ketamine treatment and many of the phase 1 tests.

Type: Interventional

Start Date: Jan 2020

open study

Study will utilize an app, Matter Neuroscience, designed to help users with depression understand positive emotions and the neurotransmitters that create them. We hope to learn the safety and efficacy of neurofeedback for treating depression and lay the groundwork for a pivotal clinical trial.

Type: Interventional

Start Date: Aug 2025

open study

The goal of this study is to learn about how the hormone insulin controls blood sugar in a variety of people. The main question it aims to answer is about how much insulin the body actually needs to maintain a normal blood sugar level. Participants will be asked to come in for a one-day study visit in which they will undergo a "graded insulin suppression test" ("GIST"). The GIST involves intravenous (into the vein) infusions of octreotide, a medication that turns off the body's own production of insulin, as well as replacement of insulin at two different levels (low and high), with or without replacement of glucagon, and glucose (sugar). The study investigators will check blood sugar levels every few minutes during the procedure to determine the effect of the two different insulin levels. This study will evaluate the GIST in both healthy volunteers and those at higher risk for type 2 diabetes.

Type: Interventional

Start Date: Sep 2024

open study

The aim of this study is to characterize the microbiome and assess fatigue and cognition of patients with cancer undergoing standard of care treatment.

Type: Observational

Start Date: Mar 2024

open study

This early feasibility study is intended to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Type: Interventional

Start Date: Feb 2024

open study

The goal of this clinical trials is to learn if healthy young African American (AA) adults have a larger change in their kidney blood flow during exercise compared to White (W) adults. The main questions that this study aims to answer are: - Do healthy young AA adults have a larger decrease in kidney blood flow during exercise compared to W adults? - Do healthy young AA adults have a larger decrease in kidney blood flow during other types of stress compared to W adults? During two visits in the research lab, participants will: - Perform a fitness test - Perform cycling exercise while lying down - Undergo a cold hand test - Perform a mental math test Completing this clinical trial will help researchers to understand more about why many AA adults have heart and kidney problems, so future research can study ways to reduce the number of AA adults who have these health issues.

Type: Interventional

Start Date: Sep 2024

open study

This study aims to examine the effects of a game-like program called cognitive control training (CT) for children with obsessive compulsive disorder (OCD). Children enrolled in this study will receive 4 weeks of the at-home computerized cognitive training program (AKL-T01) delivered on iPad (25 minutes/day, 5 days/week). Styled as a child-friendly video game, AKL-T01 CT taps focused attention, response inhibition, and working memory using a series of games to engage cognitive control processes. Children will complete the NIH Toolbox prior to, mid (2-weeks), and post-CT (4-weeks). Participants will complete MRI scans pre- and post-CT and then be offered a 12-week course of gold-standard Cognitive behavioral therapy with exposure and response prevention (or community referrals) after CT. The long-term goal of this study is to test how this CT intervention may enhance cognitive control capacity to reduce symptoms and improve response to cognitive behavioral therapy with exposure and response prevention in children with OCD.

Type: Interventional

Start Date: Jun 2024

open study

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin on bone health in children with autism spectrum disorder, ages 6-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (30 IU, 2 times daily) for 12 months in the double-blind phase, followed by a 6-month open label phase during which all study subjects will receive intranasal oxytocin (30 IU, 2 times daily). Study visits include screening to determine eligibility, followed by study visits at baseline, week 2, and months 6, 12, 18 and phone calls every two weeks for the first two months and monthly thereafter for the duration of the study. Study assessments include history and physical examinations, anthropometric measurements, electrocardiogram (EKG), adverse event monitoring, laboratory tests for chemistries, hormones and biomarkers for bone metabolism, questionnaires regarding diet and exercise, and imaging to assess body composition, bone density and structure.

Type: Interventional

Start Date: Aug 2023

open study

This is a single-center, parallel-arm, blind, sham-controlled, feasibility randomized controlled trial (RCT) to be conducted in healthy cesarean-born children. Eligible children will be randomized 1:1 to have their nose swabbed with either maternal vaginal secretions or a sterile swab (intervention vs. control group, respectively). The main hypothesis is that conducting an RCT assessing the utility of vaginal seeding in modifying the early-life upper respiratory tract (URT) microbiome of children born by cesarean section (C-section) is feasible and that the intervention is safe.

Type: Interventional

Start Date: Nov 2022

open study

The goal of this clinical trial is to test whether our dietary intervention can prevent or lessen the negative health effects of night shift work in healthy participants. Participants will: - complete 2 inpatient stays - be provided with identical meals - have frequent blood draws - provide urine, saliva, stool and rectal swab samples

Type: Interventional

Start Date: Mar 2023

open study

The purpose of this study is to obtain biologic materials from the blood, airways and/or urine of normal individuals and individuals with lung disease. The normal are used to establish a set of normal ranges for various parameters. These provide control information when compared to individuals with various pulmonary diseases, and will help in understanding of the etiology and pathogenesis of various lung diseases. The underlying hypothesis is that the pathologic morphological changes in the airway epithelium must be preceded by changes in the gene expression pattern of the airway epithelium and potentially in macrophages.

Type: Observational

Start Date: Aug 2012

open study

The goal of this observational study is to learn more about how genes impact the risk of breast cancer. Anyone 18 or older living in the US is eligible, and a diagnosis of cancer 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: Apr 2024

open study

This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D). Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose). Participants will be asked to complete assessments of pain, depressive symptoms, and more general questionnaires regarding the participants experiences during the experimental sessions and the associated enduring effects.

Type: Interventional

Start Date: Apr 2024

open study

Eating disorders (EDs) are serious mental illness: someone dies of an ED every 52 minutes. EDs are highly related to a host of negative outcomes, including public health and individual disease burden, medical and psychological comorbidities, and social determinants of health (SDOH). Treatment response for EDs are suboptimal; there are no evidence-based treatment for adults with anorexia nervosa (AN) or Other Specified Feeding or Eating Disorder (OSFED) and only 50% of adults respond to current evidence based treatments. There are no precision treatments, nor any treatments that consider social context, in existence. Personalized treatments for EDs, that consider social contexts, are urgently needed to improve treatment response and minimize the suffering associated with these illnesses. The investigators' overall goal, extending upon their past work, is to create a treatment personalized based on idiographic (or one person) models (termed Transdiagnostic Network Informed Personalized Treatment for EDs; T-NIPT-ED). The investigators will carry out a two-phase study to systematically characterize individual mechanisms of treatment (Phase I: N=900) and then test the efficacy of each treatment module (Phase II: N=240 drawn from Phase I) compared to the current gold-standard treatment (Cognitive Behavioral Therapy Enhanced: CBT-E). The study goals are to (1) characterize the prevalence of T-NIPT-ED precision treatment mechanisms and medical and psychological comorbidities (e.g., obesity; depression), individual disease burden (e.g., disability), SDOH (e.g., food insecurity), and public health outcomes (e.g., service utilization) specific to these mechanisms, (2) identify if personalized target mechanisms improve when matched to evidence-based treatment modules of T-NIPT-ED and (3) test if change in T-NIPT-ED is associated with improved outcomes (vs CBT-E), including ED outcomes, comorbidities, disease burden, and public health outcomes and if these outcomes are moderated by SDOH. These goals will ultimately lead to the very first precision treatment for ED and can be extended to additional psychiatric illnesses. The proposed research uses highly innovative methods; intensive longitudinal data collected with mobile technology is combined with state-of-the art idiographic modeling methods to deliver a virtual, personalized treatment. This proposal integrates assessment of broad (e.g., SDOH; public health burden) and specific (e.g., ED symptoms) outcomes, to ensure that social context can be integrated into personalization. The proposed research has high clinical impact. Ultimately, this proposal will lead directly to the creation and dissemination of an evidence-based individually-personalized treatment for EDs, as well as will serve as an exemplar for precision treatment development across the entire field of psychiatry.

Type: Interventional

Start Date: Jan 2024

open study

Hypertensive disorders of pregnancy (including preeclampsia) are among the leading causes of pregnancy complications and maternal deaths worldwide. They also increase the risks to the babies. Numerous interventions have been suggested in order to reduce the rate of preeclampsia. Low-dose aspirin is the most beneficial prophylactic approach in this regard. Nevertheless, aspirin failure is not uncommon. The genetic, laboratory, and clinical factors associated with low-dose aspirin failure in the prevention of preeclampsia are largely unknown. The presence of a genetic variant in PAR4 receptor expressed on platelets, is associated with increased platelet function and possibly with aspirin failure.

Type: Interventional

Start Date: Apr 2023

open study

This is a first-in-human clinical trial to test whether a protein administered into the brain continuously by gene therapy, Brain-Derived Neurotrophic Factor (BDNF), will slow or prevent cell loss in the brains of people affected by Alzheimer's disease and Mild Cognitive Impairment. The protein may also activate cells in the brain that have not yet deteriorated. Gene therapy refers to the use of a harmless virus to have brain cells make the potentially protective protein, BDNF.

Type: Interventional

Start Date: Feb 2022

open study

Approximately 30% of children will experience an anxiety disorder, making anxiety the most common mental health problem among children in the United States. However, few children receive treatment and even our most effective anxiety treatments leave up to half of children in need of additional intervention. Despite the well-established role of parent anxiety in transmitting and maintaining child anxiety, the lack of data on specific parent mechanisms underlying the intergenerational transmission of anxiety is a critical barrier to informing novel targets of personalized treatments. Consistent with NIMH's Strategic Plan, Objective 2.2 to understand risk factors and behavioral indicators of mental illness across the lifespan and to identify novel intervention targets based on knowledge of psychological mechanisms, the current study focuses on interpretation bias, the tendency to perceive threat in ambiguous situations. The overall objective of this project is to empirically test a theoretical model of the intergenerational transmission of anxiety focused on parent interpretation bias as a root cause. Our specific aims are to test theorized effects of parent interpretation bias on (1) parent behavior and (2) child interpretation bias and (3) evaluate potential moderators to refine theories of intergenerational transmission of anxiety and inform future personalized interventions. Our central hypothesis is that parent interpretation bias influences child interpretation bias through its effects on maladaptive, anxiety-promoting parenting behaviors, such as accommodation and modeling of avoidant coping. To test this hypothesis, we will randomize 300 parents of children ages 7-12 to complete four weeks of a smartphone delivered interpretation bias manipulation vs. a self-assessment smartphone app condition. The interpretation bias intervention teaches parents to interpret ambiguous situations in a non-threatening manner via quick, repeated practice and corrective feedback. Before and after completing their randomly assigned condition, parent-child dyads will complete self-report and behavioral tasks designed to elicit anxiety-promoting behaviors from parents depending upon their interpretation of the ambiguous situation (speech and puzzle tasks). Parents will also complete Ecological Momentary Assessment (EMA) of parenting behaviors to capture the time course of effects. Finally, we will examine downstream effects of the interpretation manipulation on child interpretation bias at pre- and post- visits. We will test moderators (e.g., parent anxiety and gender) to refine theories of intergenerational transmission of anxiety and inform future personalized interventions. The long-term goal of this work is to inform personalized, mechanism-focused interventions to improve mental health outcomes for anxious children and their parents. Future studies will translate knowledge gained from this project into a scalable treatment that can be implemented entirely remotely via smartphone thereby increasing access to care

Type: Interventional

Start Date: Jul 2023

open study