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Found 2 Actively Recruiting clinical trials
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
Researchers are studying VE303, a live biotherapeutic product made of nonpathogenic bacteria strains, to evaluate its safety and effectiveness in preventing recurrent Clostridioides difficile infection CDI. This Phase 3 trial compares VE303 to a placebo in participants who recently completed standard antibiotic treatment for CDI. The study focuses on two groups those with recurrent CDI and individuals at high risk for primary CDI recurrence. Participants will receive either VE303 or a matching placebo capsule three times daily for 14 days, following 10 to 21 days of standard antibiotic therapy for CDI. VE303 capsules contain the study bacteria, while placebo capsules contain a non-active substance identical in appearance. Both groups complete this treatment regimen as part of the trial. During the study, participants are monitored for safety and CDI recurrence up to 8 weeks after treatment starts. Researchers collect stool samples and track symptoms to assess recurrence rates. The study uses a randomized, double-blind design to ensure unbiased results, and participants are followed closely through the treatment and observation periods, which last several weeks.