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NCT ID: NCT06281301 Recruiting - Macrosomia, Fetal Clinical Trials

Improving Patient Understanding of Macrosomia

Start date: January 30, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of a graphic based education tool on patient knowledge of macrosomia through the use of a survey and to evaluate knowledge at 1-2 weeks after initial review of the education tool.

NCT ID: NCT06281249 Not yet recruiting - Labor Pain Clinical Trials

Neuraxial Ultrasound Device Study

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

The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method.

NCT ID: NCT06281171 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Evaluation of SkillTalk for Autistic Young Adults

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

The goal of this clinical trial is to evaluate the effectiveness of using a Microskills video training library for young adults, aged 18-28, with autism spectrum disorder (ASD) to enhance their skills in developing and maintaining healthy relationships. The main questions it aims to answer are: - Does using SkillTalk increase autistic young adults skills in the communications skills that are demonstrated in the video curriculum (skills: resolve conflict, compromise, give feedback)? - Does using SkillTalk increase reported confidence and satisfaction in communication and relationship skills? - Does using SkillTalk increase interpersonal competence? - Does using SkillTalk increase ability to cope with rejection? - Does using SkillTalk improve mental health and wellbeing? Participants will be asked to: - Take a survey at the beginning of the study, after one month the end of the study, and at 3-month follow up - Participate in recorded video calls with projects staff, comprised of 2-3 brief roleplay scenarios of relationship skills at the beginning of the study, after one month the end of the study, and at 3-month follow up - Watch a minimum of 85% of the 60 minutes of video assigned

NCT ID: NCT06281158 Completed - Healthy Volunteers Clinical Trials

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants

Start date: March 1, 2024
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343.

NCT ID: NCT06280976 Recruiting - Clinical trials for Coronary Artery Disease

Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)

ARTCAP
Start date: March 1, 2024
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the role of coronary CT angiogram (CCTA) as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions. The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes. Participants aged 18-80 years, at intermediate or high-risk for coronary artery disease, with non-obstructive plaque on initial CCTA, will be enrolled in this study. They will be randomized into Standard of Care (SOC) vs. Aggressive Therapy (AT) groups. Both groups will undergo dietary and lifestyle interventions. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. The second CCTA will be performed at 18 months to assess the change in plaque burden, characteristics, ischemia and pericoronary/epicardial fat.

NCT ID: NCT06280950 Not yet recruiting - Liver Transplant Clinical Trials

Expanding Liver Transplant Immunosuppression Minimization Via Everolimus

ELIMINATE
Start date: June 30, 2024
Phase: Phase 2
Study type: Interventional

This is a study to determine the safety, efficacy, and tolerability of taking away the anti-rejection medicine, tacrolimus, in liver transplant recipients in conjunction with everolimus monotherapy to preserve renal function. Two hundred - seventy (270) subjects will be randomized 2:1 into one of two groups between 2-3 months post-transplant. Seventy participants will be placed into an observational group and will remain on their current post-transplant medications. The duration of the study from time of enrollment is 18-20 months.

NCT ID: NCT06280859 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Hoosier Sport: Developing and Implementing a Sustainable Campus-Community Partnership in Rural Indiana

Start date: February 20, 2024
Phase: N/A
Study type: Interventional

The clinical trial aims to develop and pilot test a multilevel physical activity (PA) intervention called the Hoosier Sport program. The study follows a participatory co-design protocol involving youth, parents, and community leaders to provide direct input into the intervention's design. The ultimate goal is to contribute to health equity in the community by promoting sustainable physical activity. Hoosier Sport involves delivering enhanced physical education classes, teaching about nutrition and exercise, as well as developing leadership skills in middle school rural students.The intervention will last for 8-weeks with PE classes occur twice a week. Additionally, Hoosier Sport will create more opportunities for students to be active at school (e.g., in home room) through providing virtual classes and other activities.

NCT ID: NCT06280833 Recruiting - Genetic Counselor Clinical Trials

Care Choreographies and the Making of the Psychosocial in Genetic Counseling

Start date: June 26, 2024
Phase:
Study type: Observational

Background: Genetic counselors play a new and evolving role in medical care. Recent advances in genetic testing are changing many health care treatments, and genetic counselors play a key role in teaching people how their genes may affect both health and treatments. Genetic counselors may also help guide people through complex talks about their treatment risks; their chances for recovery; and their social and emotional health and wellbeing. Researchers want to learn more about the role genetic counselors play in health care. Objective: To observe how genetic counselors at NIH manage the social and psychological aspects of patient care. Eligibility: Genetic counselors who work at NIH. People aged 18 years or older who are scheduled to meet with one of these counselors are also needed. Design: An investigator will sit in on the session between the counselor and the participant. The investigator will take notes. The session will not be recorded. The investigator will leave at any point if asked. The investigator will focus on talk about social and psychological care. That person will also listen to talk about risk; diagnosis; odds of recovery; and hope, grief, and loss. That person will note strategies that help the participant manage their emotions and how they perceive their risks. Counselors may later have a 1-hour interview with the investigator. They will answer questions about their experiences as a care provider at NIH. Participants will have only 1 session with the investigator. Counselors may have 4 to 10 sessions with an investigator over 8 months.

NCT ID: NCT06280820 Not yet recruiting - Heart Failure Clinical Trials

Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)

Start date: June 26, 2024
Phase:
Study type: Observational

Background: More than 6.5 million people in the United States live with heart failure (HF), and more than a million new cases are diagnosed each year. Treatments have improved in recent years, but researchers want to understand more about how HF develops. To do this, they need to compare blood and other samples from many people with HF. Objective: To collect blood and other samples from people with HF. These samples will be used to identify and study proteins and other factors that may lead to decreased heart function over time. Eligibility: People aged 18 years and older with heart failure. Design: Participants will be asked to join the study based on a review of their medical records. They will have 1 study visit. They will provide a blood sample: About 3 tablespoons will be collected from a needle inserted into a vein. Other tests are optional: Participants may provide urine and stool samples. They may have a cotton swab rubbed on the inside of the mouth to collect DNA. Participants may also take 3 questionnaires. They will answer questions about dietary, social, and other factors that affect their health. Participants will receive compensation. Researchers will follow the participants health by monitoring their medical records for up to 5 years.

NCT ID: NCT06280807 Recruiting - Hypogonadism Clinical Trials

Observation of Environment and Reproductive-Endocrine Effects

Start date: June 26, 2024
Phase:
Study type: Observational

Background: Endocrine disorders occur when the glands that make hormones do not work properly. Hormones levels that are too high or too low can cause problems such as late or early puberty, irregular periods, and infertility. Environmental factors - including pollution; chemical exposure at home and work; foods; medicines; and sleep habits - may cause problems with the endocrine and reproductive systems. Objective: To learn how environmental factors may affect the endocrine and reproductive systems. Eligibility: Males or females, referring to sex assigned at birth, aged 8 years and older; they must have hypogonadism, infertility, or other reproductive disorders. Design: Adult participants will have 4 to 5 visits in 5 years. Children may have up to 12 visits; they may remain in the study up to the age of 23. Most visits will be less than 3 hours. Participants will be screened. They will have a physical exam. They will have blood and urine tests. They will complete questionnaires; they will answer questions about their diet, health, and other topics. Some may be referred for additional tests, such as imaging scans and semen analysis. Specific tests conducted during study visits will vary, depending on the participant s diagnosis. In addition to repeated blood and urine tests, these may include: Body composition measure: Participants will sit in a pod-shaped machine for about 6 minutes. The machines measures the air inside the capsule to record body fat and breathing volume. Resting energy expenditure test: Participants will lie down with a clear dome placed over their head. They will breathe quietly for 30 minutes. This test measures the number of calories their body burns at rest. ...