Maryville

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential effectiveness of the investigational drug ENV-294 in adults with moderate to severe asthma who are already using inhaled corticosteroids and long-acting beta2-agonists. This phase 2, randomized, double-blind, placebo-controlled study aims to better understand how ENV-294 works and how safe it is for this population. The study is sponsored by Enveda Therapeutics and involves adult participants aged 18 to 75 years with a physician diagnosis of moderate to severe asthma for at least one year. Participants will be randomly assigned to receive either oral ENV-294 tablets or matching placebo tablets once daily for 12 weeks. Prior to starting treatment, there is a screening period of up to 28 days to confirm eligibility based on lung function, asthma control, and medical history. Those in the treatment arm will take ENV-294 under supervision, while those in the placebo arm will take a similar-looking tablet without active drug. All participants continue their background asthma treatment with inhaled corticosteroids and long-acting beta2-agonists. Throughout the study, participants will attend scheduled visits for monitoring safety, measuring drug levels in the blood, and evaluating asthma control and lung function. Assessments include tracking adverse events, lung function tests, asthma control questionnaires, and monitoring for asthma exacerbations. The primary outcome is the incidence and severity of adverse events from the first dose through approximately 16 weeks. Participants are observed closely to understand how ENV-294 affects asthma symptoms and overall health during and shortly after the 12-week treatment period.

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.