Dover

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.

Researchers are investigating how well standard systemic therapy, with or without additional definitive treatment such as prostate removal surgery or radiation therapy, works in treating men with prostate cancer that has spread to other parts of the body. This phase III trial aims to compare overall survival and progression outcomes between patients receiving systemic therapy alone and those receiving systemic therapy plus definitive treatment of the primary tumor. The study also examines quality of life factors, including urinary function, pain, and physical functioning. Participants first receive one of six acceptable forms of standard systemic therapy for 22 to 28 weeks, which may include hormonal therapies, oral medications, injections, or chemotherapy drugs like docetaxel. After this induction period, participants are randomly assigned to continue standard systemic therapy alone or to receive systemic therapy plus prostatectomy or radiation therapy within a specific timeframe. Following treatment, participants are monitored and followed up for up to eight years. During the study, participants undergo various assessments including physical exams, laboratory tests for prostate-specific antigen PSA and testosterone levels, and imaging scans to monitor disease progression. Patient-reported outcomes related to urinary symptoms, pain, and quality of life are collected at multiple time points up to three years. The main outcome measured is overall survival over an eight-year period. Researchers also bank tissue and blood samples for future studies and observe safety and disease progression throughout the follow-up period.