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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating letrozole treatment in women newly diagnosed with uterine leiomyosarcoma, a type of cancer limited to the uterus. This randomized phase II study compares daily letrozole to observation to see if letrozole can extend the time patients remain free from disease progression. The main goal is to measure progression-free survival up to three years from randomization. Participants will be randomly assigned to receive either 2.5 mg of letrozole orally once daily or no treatment observation. The study includes patients with early-stage disease FIGO 2009 Stage I who have completed surgery with hysterectomy and bilateral salpingo-oophorectomy within 12 weeks before enrollment. The study uses adaptive randomization to assign patients to either group. During the trial, participants will be monitored regularly to detect any disease progression or death. The main measurement is the time from enrollment until progression or death. Participants must meet specific health criteria, including no measurable disease at enrollment and adequate organ function. The study will continue until July 2029, with primary outcome data collected up to three years after randomization.

Age: 18Years +FEMALEPhase 2
34 locations
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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