Conway

Researchers are evaluating the effects of MELT-300 on procedural sedation in adults undergoing cataract extraction with lens replacement CELR. This Phase 3 clinical trial aims to compare MELT-300 with a placebo and an active comparator, sublingual midazolam, to assess the contribution of ketamine in the combined drug product. The study focuses on the effectiveness and safety of MELT-300 during and after cataract surgery. Participants will be randomly assigned to one of three groups MELT-300 a sublingual tablet containing 3 mg midazolam and 50 mg ketamine, midazolam alone 3 mg sublingual tablet, or a placebo tablet. They will receive a single dose of the assigned medication approximately 30 minutes before surgery without food or water. The surgery will be performed under topical anesthesia, and the study medication effects will be assessed before, during, and after the procedure. Participants will be admitted on the day of surgery and monitored throughout. Researchers will assess sedation levels, the need for additional sedation or pain medication, and the ability to complete surgery. Safety will be tracked through adverse event monitoring, vital signs, and physical exams at baseline, during surgery, and up to three days after medication. The primary outcome measured is the percentage of participants achieving successful procedural sedation at various time points on the day of surgery.

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 aims to evaluate whether switching completely to e-cigarettes can help people who smoke and are undergoing treatment for substance use disorders SUD quit smoking, compared to using FDA-approved nicotine replacement therapy NRT such as patches and lozenges. Tobacco use remains high among those with SUD despite declines in the general population, and quitting smoking during SUD treatment is challenging but important for better health outcomes. The study also seeks to understand implementation barriers and how these treatments affect SUD progress over 12 weeks. Participants will be randomly assigned to one of two groups one group will receive twelve weeks of e-cigarette products with instructions to switch completely from cigarettes, while the other group will receive twelve weeks of combination NRT patches plus nicotine lozenges to support quitting smoking. Both groups will also receive brief weekly counseling to support their quit or switch attempts. The study period includes 12 weeks of treatment with follow-up assessments. Participants will be involved for six months, including five in-person visits and eleven virtual assessments. They will complete a daily diary on their phones for the first twelve weeks. Researchers will monitor smoking abstinence verified biologically at the end of treatment, evaluate how acceptable the treatments are, and assess substance use outcomes through urine drug screens. Safety and participant engagement will also be tracked throughout the study.