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Found 2 Actively Recruiting clinical trials

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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.

Age: 18Years +All Genders
2368 locations
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Actively Recruiting

Researchers are evaluating a twice-weekly, moderate intensity exercise and coaching program for adults with mild to moderate cognitive impairment living in South Carolina. The study aims to determine whether the program is practical, acceptable, and enjoyable, and whether participants show changes in endurance, mobility, cognitive function, and perception of cognition at 3, 6, 9, and 12 months. The study is led by the University of South Carolina and focuses on maintaining or improving cognitive and physical abilities. Participants join either an in-person exercise group in Columbia, SC, or a distance exercise group in Sumter, SC. The in-person group attends twice weekly sessions at a fitness center with real-time coaching and feedback, including endurance, strength, balance, and mobility exercises. The distance group receives personalized exercise plans, attends up to seven initial visits with a fitness trainer, and completes the rest of the exercise sessions independently, logging their activity and intensity with support from coaches via phone, text, or email. Throughout the study, participants wear heart rate monitors and have their exercise sessions tracked for intensity, duration, and adherence. Assessments of cognitive function, endurance, mobility, balance, grip strength, and perception of cognition are conducted at baseline and at 3, 6, 9, and 12 months. The main outcomes include feasibility measures like recruitment and adherence, as well as exploratory measures of cognitive and physical function changes over the year-long study.

Age: 18Years +All GendersPhase Not Applicable
2 locations