Wayne

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 evaluating the effectiveness and safety of Dabogratinib TYRA-300 in people with low grade upper tract urothelial carcinoma, a type of cancer affecting the urinary tract. This Phase 2AB open-label study focuses on patients with FGFR3-positive tumors and aims to understand how well the drug works in reducing tumor presence within six months. Participants will receive daily oral doses of Dabogratinib at different strengths60mg, 80mg, or a dose to be determined. The study is randomized and involves multiple centers, with participants assigned to one of three dose groups to assess the drugs impact and safety. During the trial, participants will be monitored for response to treatment, including complete tumor response within six months and duration of response up to 36 months. Safety and kidney function will be observed for up to two years, alongside other measures like tumor resectability and renal preservation. The total participation duration spans until the studys completion in November 2030.