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NCT ID: NCT06406465 Not yet recruiting - Clinical trials for Carcinoma, Neuroendocrine

A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity

Start date: June 26, 2024
Phase: Phase 2
Study type: Interventional

Background: High-grade neuroendocrine carcinomas (HGNEC) are cancers that develop in different parts of the body, including the digestive tract, genitals, neck, and head. One drug (belinostat), combined with 2 other drugs (etoposide and cisplatin), is approved to treat HGNEC. But some people may have a gene variant that affects how quickly their body gets rid of the drug; these people may do better with different dosages of belinostat. Objective: To test higher or lower doses of belinostat based on gene variants in people with HGNEC. Eligibility: People aged 18 years and older with HGNEC. Design: Participants will be screened. They will have a physical exam with blood tests. Some blood will be used for genetic testing. They will have imaging scans and a test of their heart function. Samples of tumor tissue may be collected. All 3 study drugs (belinostat, etoposide, cisplatin) are given through a tube attached to a needle inserted into a vein. Treatment will be given in 21-day cycles. For cycles 1 through 6: Participants will come to the clinic for the first 4 days. They will be given all 3 drugs. Imaging scans and other tests will be repeated. Each visit will last 4 to 8 hours. After cycle 6: Participants may continue treatment with belinostat alone. They will come to the clinic for the first 3 days of each cycle. They may continue treatment for up to 5 years if the drug is helping them. Participants will have a follow-up visit 30 days after their last dose of belinostat. Then they will receive follow-up visits by phone or email every 3 to 6 months.

NCT ID: NCT06406452 Not yet recruiting - Clinical trials for Tracheobronchomalacia

Bioresorbable Airway Splint Pivotal Clinical Trial

Start date: May 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to learn if a three-dimensional (3D) printed airway splint device made to hold open a collapsing airway is a safe and effective treatment of Tracheobronchomalacia (TBM) in children. The airway splint is bioresorbable, meaning the child's body will absorb the splint over about five years.

NCT ID: NCT06406114 Not yet recruiting - Clinical trials for Drug Hypersensitivity

Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing

DACAT
Start date: August 1, 2024
Phase: Phase 2
Study type: Interventional

Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.

NCT ID: NCT06406049 Not yet recruiting - Hiv Clinical Trials

Finishing HIV Project

Start date: December 15, 2024
Phase: N/A
Study type: Interventional

This study aims to learn how to help enable healthy behaviors and lower the risk of HIV among Latinx Men.

NCT ID: NCT06405503 Not yet recruiting - Clinical trials for Inflammatory Bowel Disease

Impact of Primary Language on Treatment and Outcomes in Inflammatory Bowel Disease

Start date: June 1, 2024
Phase:
Study type: Observational

A thorough discussion of treatment options to manage inflammatory bowel disease (IBD), including the risks and benefits of each class of medication, can be a complex discussion and time consuming. Having to use a translator adds an additional layer of time and complexity to these discussions as well as potential misunderstanding. Further, in addition to language, cultural differences can also play into treatment acceptance. This study aims to determine the impact of primary language on the selection of treatment for IBD and on disease outcomes.

NCT ID: NCT06405386 Not yet recruiting - Diabetes Mellitus Clinical Trials

Pilot of Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes

ChargeUp
Start date: May 2024
Phase: N/A
Study type: Interventional

This study is designed to test the feasibility and acceptability of behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. This is a pilot study, which will enroll a small group of participants to enroll and give feedback on their experience. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the intervention, participants will attend focus groups and fill out anonymous qualitative surveys to give feedback on their experience. Results of the pilot will inform and improve an upcoming research study of the same design.

NCT ID: NCT06405373 Not yet recruiting - Diabetes Mellitus Clinical Trials

Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes

ChargeUp
Start date: May 2024
Phase: N/A
Study type: Interventional

This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the initial intervention, participants will complete surveys to assess their response to the material. Participants who are determined to be "non-responders" (i.e., the Primary intervention was not effective) will be re-randomized to one of two "Supplementary" interventions, which will include individualized sessions to learn and/or practice strategies related to either the psychological or problem-solving approach.

NCT ID: NCT06405334 Not yet recruiting - Parkinson's Disease Clinical Trials

Kinematic and Neural Dynamics of Postural Instability in Parkinson's Disease

Start date: July 1, 2024
Phase:
Study type: Observational

Balance problems and falls are among the most common complaints in Veterans with Parkinson's Disease (PD), but there are no effective treatments and the ability to measure balance and falls remains quite poor. This study uses wearable sensors to measure balance and uses deep brain stimulation electrodes to measure electric signals from the brain in Veterans with PD. The investigators hope to use this data to better understand the brain pathways underlying balance problems in PD so that new treatments to improve balance and reduce falls in Veterans with PD can be designed.

NCT ID: NCT06404970 Not yet recruiting - Frailty Clinical Trials

A Partnered Evaluation to Improve the Identification and Management of Functional Impairment and Frailty Among Older Veterans in Primary Care Settings

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Maintaining functional status, or the ability to perform daily activities, is central to older adults' quality of life, health, and ability to remain independent. Identifying functional impairments is essential for clinicians to provide optimal care to older adults, and on a population level, understanding function can help anticipate service needs. Yet uptake of standardized measurement of functional status into patient care has been slow and inconsistent due to the burden posed by current tools. The purpose of the proposed QUERI Partnered Evaluation Initiative is to implement and evaluate a patient-centered, low-burden intervention to improve measurement of functional status in VA primary care settings nationally. The investigators hypothesize that implementing this intervention will increase identification and improve management of functional impairment among older Veterans while providing key data to inform VHA strategic planning related to long-term services and supports.

NCT ID: NCT06404515 Not yet recruiting - Clinical trials for Coronary Artery Disease

Telehealth Group Counseling and Preventive Care for Women

Start date: May 24, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to utilize an innovative healthcare delivery strategy via telehealth group counseling sessions to improve engagement, adherence, and ultimately outcomes in female patients with atherosclerotic cardiovascular disease (ASCVD).