Frankfort

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.

This research study focuses on participants of all ages diagnosed with Chronic Granulomatous Disease CGD, a condition characterized by defective NADPH oxidase activity or specific genetic mutations. The study aims to understand how common certain adenovirus antibodies and inflammatory cytokines are in this group by measuring their levels in the blood. This observational study is sponsored by Ensoma and seeks to provide insight into immune markers in CGD patients. Participants will provide blood samples to allow researchers to measure total adenoviral-specific antibody titers, adenoviral-specific neutralizing antibody titers, and circulating inflammatory cytokine levels. These measurements will be taken once during the study to characterize the prevalence of these immune markers in both adult and pediatric CGD patients. During the study, participants will have blood collected for analysis of the specified antibodies and cytokines. Researchers will evaluate the levels of these markers to better understand immune responses in CGD. The study requires only a single visit for sample collection and assessment. Safety and compliance will be monitored through the ability to complete the sample collection procedure, and the total participation time is limited to this one-day visit.