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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

This prospective, interventional trial is intended to determine the safety and effectiveness of the Variable Compression System (VCS) device for Irritable Bowel Syndrome (IBS). This pilot study will enroll 20 subjects who will be required to wear the VCS device for a minimum of 6 hours a day and follow up at 21 days, 8 weeks, and 6 months post-device administration.

Age: 18Years - 60YearsAll GendersPhase Not Applicable
3 locations
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Actively Recruiting

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Age: 18Years +All Genders
2284 locations
M

Actively Recruiting

Researchers are evaluating a mindful walking intervention designed for older South Asian family caregivers aged 45 and older who care for people with cognitive disabilities and experience psychological stress and limited physical activity. This pilot randomized controlled trial aims to address the lack of studies combining physical activity and cognitive training for this underserved and growing population in the US. The study is driven by a Community Advisory Committee and conducted in partnership with UIC's Cognition Behavior and Mindfulness Clinic. The intervention includes a 12-week mindful walking program that begins with training, followed by a prescribed walking regimen. Participants will self-report adherence through activity logbooks and use a Fitbit tracker for daily step counts. They will also receive personalized text messages with reminders and motivational support, plus a weekly check-in call or text for accountability. The study will enroll 50 participants, randomly assigning 25 to the intervention and 25 to a control group. Participants will be assessed at baseline, after 12 weeks, and at a 20-week follow-up. Researchers will measure perceived stress using the Acceptance and Action Questionnaire-II, visuospatial inhibitory attention with the NIH Toolbox Flanker Test, and executive functioning using the NIH Toolbox Dimensional Change Card Sort Test. The study will monitor physical activity levels, adherence, and self-efficacy related to stress coping and physical activity. The primary goal is to evaluate feasibility and acceptability, with secondary aims assessing preliminary efficacy in reducing stress and improving cognitive function.

Age: 45Years +All GendersPhase Not Applicable
8 locations