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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 drug called cemiplimab for treating early-stage Cutaneous Squamous Cell Carcinoma CSCC, a type of skin cancer. Cemiplimab helps the immune system attack cancer cells by targeting a protein called PD-1 on immune cells. The studys main goal is to compare how well cemiplimab works when injected directly into the lesion versus standard surgery. Participants will be randomly assigned to receive either cemiplimab injected into the lesion or undergo primary surgery using techniques like Mohs surgery or other complete margin assessment methods. The study will assess side effects and how well cemiplimab performs compared to surgery in treating the cancer. During the study, participants will be monitored for event-free survival up to 3 years. Researchers will also evaluate lesion response, treatment-related adverse events, and sizes of surgical or biopsy defects. The total participation period extends up to 3 years, with regular assessments to track safety and treatment effectiveness.

Age: 18Years +All GendersPhase 3
52 locations