Frankfort

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.

This research study focuses on individuals, including both adults and children, diagnosed with Chronic Granulomatous Disease (CGD). The study aims to understand how common certain antibodies against adenovirus and inflammatory proteins called cytokines are in people with CGD by measuring their levels in the blood. Blood samples will be collected from participants to measure the amount of adenovirus-specific antibodies and inflammatory cytokines circulating in their bodies. This is an observational study, meaning participants will not receive any treatments as part of the research; instead, their blood markers will be analyzed to learn more about their immune response. Participants will provide blood samples during the study, and the researchers will analyze these samples for total adenoviral-specific antibody levels and adenoviral-specific neutralizing antibody levels. The study also involves measuring inflammatory cytokines. The results will help characterize the prevalence of these markers in people with CGD. Participants or their guardians must provide informed consent and be able to follow study procedures.