Batavia

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating whether adding stereotactic body radiation therapy (SBRT) to the usual treatment improves outcomes for patients with locally advanced, inoperable non-small cell lung cancer that has spread to nearby tissues or lymph nodes. This phase III trial compares SBRT combined with conventional image guided radiation therapy (IGRT), chemotherapy, and immunotherapy or targeted therapy versus the usual treatment alone. The usual chemotherapy involves drugs like cisplatin, carboplatin, paclitaxel, nab-paclitaxel, pemetrexed, and etoposide. Immunotherapy with durvalumab or targeted therapy with osimertinib is also given after chemotherapy, aiming to interfere with tumor growth and spread. Patients are randomly assigned to one of two treatment groups. In the control group, patients receive conventional IGRT with weekly or every-3-week chemotherapy followed by immunotherapy with durvalumab or targeted therapy with osimertinib. In the experimental group, patients receive SBRT to the primary tumor plus conventional IGRT to nodal metastases, combined with the same chemotherapy and consolidation therapies as the control group. Radiation therapies are delivered with precision to minimize damage to healthy tissue. Follow-up imaging with CT and/or PET/CT scans are performed during and after treatment. Participants undergo physical exams, imaging scans, pulmonary function tests, and quality of life assessments before, during, and after treatment. Researchers monitor overall survival and progression-free survival for up to eight years. They also track tumor response, local control, treatment side effects, lung function changes, and patient-reported outcomes. Follow-up visits occur every three months for one year, every six months for years two and three, and yearly thereafter to assess long-term effects and safety.