The researchers are investigating a new treatment for white matter injury, which is a common type of brain injury in premature babies. The drug, clemastine, is experimental. This means that the drug is not approved by the Food and Drug Administration (FDA) for the treatment of white matter injury. The main purpose of this study is to learn whether clemastine is safe to give to infants with white matter injury. The researchers also want to understand how much clemastine gets into an infant's body when the medication is taken by mouth, and how long it stays in the body.

Type: Interventional

Start Date: Jul 2026

open study

This is an interventional study that will test whether a breathing exercise called Inspiratory Muscle Strength Training (IMST) can safely and effectively lower blood pressure during late pregnancy. The goal is to see if a home-based breathing training can help prevent or reduce high blood pressure disorders in pregnancy. The main objectives are to make sure the training is safe and tolerable for pregnant women and to examine blood pressure and blood vessel health. Participants in their third trimester will be randomly assigned to either do moderate resistance IMST or a minimal resistance sham IMST, for 5 to 8 minutes a day over six weeks.

Type: Interventional

Start Date: Jun 2026

open study

Background: Trisomy 8 mosaicism is a genetic disorder that can increase inflammation in the body. Symptoms include fevers; sores or ulcers in the mouth, digestive tract, or genital area; skin rashes; problems in organs or tissues; and changes in bone marrow cells. Researchers want to conduct a natural history study to learn more about these symptoms and what causes them. Objective: To gather data and samples from people with and without the trisomy 8 mosaicism. Eligibility: People of any age with the trisomy 8 gene mosaicism. Their healthy relatives are also needed. Design: Affected participants will have visits every 1 to 2 years for 30 years at NIH. Each visit will take 1 to 5 days and may be in-person or remote. With remote visits, participants may have a video call with the study team and samples may be sent to researchers by mail. Participants may have these procedures: Physical exam, with blood tests. Tests of brain function and motor skills. Sensory tests. Researchers will see how participants respond to sensations such as pinpricks, heat, cold, and pressure. Magnetic resonance imaging (MRI) scan of the brain and/or spine. X-ray of the spine. Ultrasound test of heart function (echocardiogram). Tissues samples (biopsies) collected from the skin, inside of the mouth, and bone marrow. Swabs to collect cells from the mouth, skin, and vagina. Collection of blood, stool, urine, saliva, hair, and fingernail samples. X-rays, MRI, and heart tests will be done only once. Other procedures may be repeated at each visit. All tests and procedures are voluntary. Healthy relatives who enroll will have a baseline visit and then follow-up visits as needed. They will have a physical exam. The inside of their mouth may be swabbed. Samples of blood, stool, urine, and saliva may be taken.

Type: Observational

Start Date: Aug 2026

open study

This study is being conducted to look at the effect YB-101 has on thyroid function. This study will also evaluate how safe and well tolerated YB-101 is and how it is distributed through the body. The study consists of a part 1, blinded treatment period, and a part 2 double-blinded treatment period. Participants will receive YB-101 or Placebo subcutaneously. Participants who participate in Part 1 can not participate in Part 2. Participants will complete 34-39 in-clinic visits in Part 1 or Part 2 over an approximate 40 week period.

Type: Interventional

Start Date: Jun 2026

open study

The purpose of this project is to determine the feasibility and preliminary efficacy of a mental health skill-building and empowerment program (MH-POWER) for college students on the autism spectrum facing stress, anxiety, and depression. The program, grounded in cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT), and habit formation, will be implemented through weekly sessions and daily practice over 8 weeks. To evaluate the program's preliminary efficacy, we will measure mental health symptoms at baseline, mid-point, post-intervention, and one-month follow-up. Positive outcomes could lead to scalable interventions.

Type: Interventional

Start Date: Jul 2026

open study

Dystrophin associated heart dysfunction is a leading cause of death in patients with Duchenne and Becker Muscular dystrophy (DMD/BMD) and Duchenne and Becker muscular dystrophy carriers (MDC); however, the evolution of heart dysfunction is not well-understood. The central objectives of this proposal are to elucidate this evolution of heart dysfunction and identify measures from cardiac MRI images that can predict death or significant heart disease in patients with DMD/BMD/MDC. This study will create a large clinical and cardiac MRI registry of dystrophin associated heart dysfunction, will utilize advanced image analysis techniques, including deep learning neural networks, to comprehensively evaluate every patient, and will create a risk toolkit accessible to clinicians around the world; this proposal has the potential to improve the quality of life in patients with dystrophin associated heart dysfunction by allowing for earlier and more intensive therapy in patients with severe disease and by identifying surrogate outcome measures for use in therapeutic trials.

Type: Observational [Patient Registry]

Start Date: Jan 2025

open study

The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.

Type: Interventional

Start Date: Jul 2026

open study

The main purpose of this study is to assess the concentrations of nipocalimab (pharmacokinetics [PK]) in the breast milk after administration of a single dose of nipocalimab into the vein, in healthy lactating women.

Type: Interventional

Start Date: Jun 2026

open study

In this study, researchers will learn how the body processes a study drug called BIIB144. This is a "first-in-human" study. This means that this study drug will be given to people for the first very time in this study. These studies are important because they help researchers learn about the safety of the study drug, how the body processes it, and what dose might be appropriate before testing it in larger groups. The main goal of this study is to learn more about the safety of a single dose of BIIB144 compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug. The main question researchers want to answer in this study is: How many participants have adverse events (AEs) and serious adverse events (SAEs)? An AE is a health problem that may or may not be caused by the study drug. Researchers will also learn more about: - How the body processes BIIB144 compared to placebo. This study will be done as follows: - Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which eligible participants will check into their study research center. - Participants will stay at their study research center for about 8 days. Afterwards, they will have up to 13 visits to their study research center. - This will be a "dose escalation" study. In this kind of study, increasing amounts of study drug are given to different groups of participants. Usually, this is done until researchers find the highest dose that does not cause harmful effects. In this study, the number of dose groups and maximum dose are planned in advance. The dose escalation will stop once these planned groups are done or if safety concerns arise. - There will be a total of 6 groups. In each group, participants will receive a single dose of either BIIB144 or the placebo through an intravenous (IV) needle. - Throughout the study, participants will give blood and urine samples. Participants will also have physical exams and answer questions about how they are feeling. - Each participant will be in the study for up to 44 weeks.

Type: Interventional

Start Date: Jul 2026

open study

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

Type: Interventional

Start Date: Jul 2026

open study

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

Type: Interventional

Start Date: Jul 2026

open study

This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Non-Small Cell Lung Cancer

Type: Interventional

Start Date: Jul 2026

open study

The purpose of this study is to assess the impact of artificial intelligence on proximal caries detection and subsequent treatment decisions of early learners and compare those with outcomes of experienced learners.

Type: Interventional

Start Date: Jul 2026

open study

The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26. The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.

Type: Interventional

Start Date: Jun 2026

open study

The goal of this non-interventional, observational study is to describe the natural history, clinical course, and management patterns of subjects with limbal stem cell deficiency (LSCD).

Type: Observational

Start Date: May 2026

open study

This study will address the gap in coblator wands by comparing the performance of reprocessed coblator wands with new wands in terms of efficiency and technical issues. As part of the evaluation, the investigator team will conduct the technical performance of the life cycle assessment of reprocessed versus new coblation wands based on the methodology described in the literature (see References) in studies of laryngoscopes.

Type: Interventional

Start Date: Aug 2026

open study

The primary purpose of this study is to evaluate the safety and tolerability of Zunveyl® over 12 weeks of routine clinical use in adults with mild to moderate Alzheimer's disease.

Type: Interventional

Start Date: May 2026

open study

kTMP, kilohertz transcutaneous magnetic perturbations, is a low intensity transcranial magnetic stimulation technique that will be used in this study to promote arm/hand rehabilitation in patients who have been disabled by stroke.

Type: Interventional

Start Date: Jul 2026

open study

The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV/hMPV combination vaccine and investigational hMPV vaccine in younger and older adults.

Type: Interventional

Start Date: Jun 2026

open study

This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed. In this study, surgeons will use the CLiKX device to place an ear tube in the patient's ear. The study will check if the surgeon can place the tube correctly in the right position. The procedure will first be attempted with no anesthesia or with local anesthesia. If needed, the surgeon may then use mild sedation or general anesthesia. The study will also look at how well patients tolerate the procedure by checking for side affects during the procedure. Finally, the study will look at how the device affects the procedure and patient safety. Researchers will review how the procedure is performed and will follow patients for up to 30 days after the procedure to continue to check for any side effects..

Type: Interventional

Start Date: Jun 2026

open study

We hypothesize that promoting a fasting state will strengthen the anti-cancer effects of PI3K inhibitors in metastatic breast cancer (MBC) treatment. The primary objective of this study is to assess acceptability of prolonged fasting in this population.

Type: Interventional

Start Date: May 2026

open study

The goal of this study is to find out if it is safe for women with endometrial cancer who are going to have surgery to fast (not eat) overnight. Studies have shown that women with endometrial cancer often have problems with metabolism, like high blood sugar. These problems can cause inflammation and may help cancer grow or make treatment less effective. Early research shows that fasting overnight might help improve these problems.

Type: Interventional

Start Date: Feb 2026

open study

The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.

Type: Interventional

Start Date: Jul 2026

open study

The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response or intolerance to tumor necrosis factor (TNF) and/or Janus kinase (JAK) inhibitors, and who were previously treated with Afimkibart.

Type: Interventional

Start Date: Jun 2026

open study

The goal of this study is to learn what happens to a single dose of enlicitide over time in a healthy participant's body when the participant is given a single dose of MK-7262 and what happens to a single dose of MK-7262 over time in a healthy participant's body when the participant is given a single dose of enlicitide.

Type: Interventional

Start Date: Jul 2026

open study