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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating whether ataciguat can slow the progression of moderate calcific aortic valve stenosis CAVS in adults aged 50 and older. This study is conducted in two parts Part A focuses on whether ataciguat reduces calcium buildup in the aortic valve over 24 weeks, while Part B examines if the drug slows narrowing of the valve area and improves peak oxygen consumption over 48 weeks. Safety, tolerability, and how the body processes ataciguat are also assessed. Participants receive either ataciguat or a placebo daily for up to 156 weeks. Part A enrolls about 132 participants, and Part B will begin after Part A completes, enrolling around 1144 participants. Part B includes additional evaluation of heart function and ability to exercise. The study uses a randomized, double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. During the study, participants undergo imaging tests like CT scans and echocardiograms to measure valve calcium and valve area. Cardiopulmonary exercise testing CPET is used to assess peak oxygen consumption. Researchers also monitor heart function, symptoms, and quality of life using questionnaires. Assessments occur mainly at baseline, Week 24, and Week 48, with long-term follow-up to 156 weeks for safety and efficacy. The studys total duration extends to 2030.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the TeamBirth quality improvement training program aimed at improving shared decision-making during labor and delivery. This study focuses on reducing cesarean births among first-time mothers with term, singleton, vertex pregnancies, especially Black birthing people. It also aims to enhance patient experience and promote respectful care through patient participation in decision-making on labor units. The study compares the TeamBirth intervention, which uses a train-the-trainer model to support shared decision-making huddles, against usual care practices. Participants will be randomly assigned to either the TeamBirth program or usual care. The evaluation measures outcomes before and after TeamBirth implementation over specific timeframes. Participants will be monitored for cesarean birth rates and shared decision-making levels six months before and three months after the intervention starts. Patient experience is also assessed during these periods. The study includes English or Spanish speaking individuals aged 18 or older who gave birth after laboring. Outcomes focus on both overall and Black birthing people, with follow-up planned until July 2029.
Actively Recruiting
Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.