Englewood

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months 4 years, followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry DXA. Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

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 collecting data on patients with Epidermal Growth Factor Receptor EGFR-mutant Non-Small Cell Lung Cancer NSCLC who are treated outside of a clinical trial with standard care using osimertinib alone or combined with chemotherapy. The goal is to better understand the safety and effectiveness of these treatments as they are used in routine clinical practice. This is an observational study recruiting about 250 patients per treatment group, including those receiving osimertinib alone or osimertinib plus chemotherapy. Patients are treated according to standard medical care as determined by their doctors. One group receives osimertinib by mouth once daily, while the other group receives osimertinib plus chemotherapy, with chemotherapy type chosen by the treating physician. Treatment dosing and administration follow standard guidelines. The study records planned treatments at registration and observes outcomes without altering the care given. Participants will have clinical and imaging assessments as part of their usual care, with data collected on their health and treatment progress. Researchers will measure real-world progression-free survival, overall survival, and time to stopping osimertinib for up to three years. The study follows participants over time to monitor how they respond to therapy and to gather safety information.