Lorain

Researchers are evaluating the effectiveness, safety, and drug levels of Deucravacitinib BMS-986165 in adolescents aged 12 to less than 18 years who have moderate to severe plaque psoriasis. This phase 3 study is randomized, double-blind, and placebo-controlled to thoroughly assess the treatments impact on this skin condition. The study is sponsored by Bristol-Myers Squibb and aims to provide detailed information on how Deucravacitinib works in this younger population. Participants will receive either Deucravacitinib or a placebo, with doses given on specified days as part of the treatment. The study groups include an active drug group and a placebo group, and the design is parallel to compare these treatments directly. The treatment period includes monitoring drug levels and observing the participants responses over time. During the study, participants will be regularly assessed for improvements in their psoriasis using measures such as the Psoriasis Area and Severity Index PASI and the static Physicians Global Assessment sPGA at week 16. Additional evaluations include body surface area involvement, itch severity, quality of life, and antibody protection. Safety is closely monitored through laboratory tests, physical exams, vital signs, and adverse event tracking for up to five years, with ongoing measurement of growth and sexual maturation during this time.

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.