Search Bar & Filters
Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety and effectiveness of the Variable Compression System VCS device for adults with moderate to severe Irritable Bowel Syndrome IBS, including constipation-predominant, diarrhea-predominant, or mixed types based on Rome Criteria. This pilot, interventional trial aims to understand how well this wearable device works in managing IBS symptoms and its potential side effects. The study involves wearing the VCS device, which provides compression to the lower abdomen, torso support, and emits Far Infrared Radiation FIR over the torso. Participants will wear the device for at least 6 hours daily. Follow-up visits are scheduled at 21 days, 8 weeks, and 6 months after starting to use the device to monitor progress and gather data. During the study, participants will be assessed for any treatment-related side effects, including intolerable and emergent adverse events within 21 days. Researchers will also track changes in IBS symptoms. The total participation includes monitoring over several months, with evaluations at multiple time points to understand both safety and symptom changes over time.
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.
Actively Recruiting
Older South Asian family caregivers who provide care for people with cognitive disabilities often face high psychological stress and limited physical activity due to caregiving duties and barriers like cultural, linguistic, and service access challenges. This research aims to study a combined mindful walking intervention that merges physical activity with cognitive training, addressing a gap in support for this underserved and growing community. The study is a randomized controlled pilot trial designed to assess this new approach. The study will enroll fifty participants aged 45 and older who identify as South Asian family caregivers. Participants will be randomly assigned to one of two groups an intervention group that receives a 12-week mindful walking program involving training, a prescribed walking regimen, use of Fitbit trackers to monitor step counts, self-reporting adherence via logbooks, personalized motivational text messages, and weekly check-ins and a control group that receives educational materials about walking benefits without mindfulness components and neutral text messages. At study end, the control group will also access recorded mindful walking training. Participants will be evaluated at baseline, after 12 weeks, and at a 20-week follow-up. Assessments will include measures of perceived psychological stress, cognitive function tests focusing on attention and executive function, physical activity levels using questionnaires and accelerometers, and self-efficacy scales related to stress coping and physical activity. The study aims to determine the feasibility and acceptability of the intervention and gather preliminary data on its effects, with the total participation spanning at least 20 weeks.