Destin

Researchers are evaluating the effects of dupilumab treatment on children aged 2 to under 6 years with uncontrolled asthma andor recurrent severe asthmatic wheeze. This Phase 3 study aims to assess both the efficacy and long-term safety of dupilumab compared to a placebo. The study is conducted in two parts to thoroughly evaluate treatment outcomes and safety over an extended period. In Part A, children will be randomly assigned to receive either dupilumab or a matching placebo through subcutaneous injections over a 52-week treatment period following a 4-week screening phase. After this, there is a 12-week follow-up to monitor any ongoing effects. Participants who qualify may choose to enter Part B, an optional open-label extension where all receive dupilumab for an additional 52 weeks, followed by another 12-week safety follow-up. Throughout the study, participants will be regularly assessed for asthma exacerbations, medication use, symptom control, quality of life, and medication safety. Caregivers will complete diaries and questionnaires about asthma symptoms and control. Blood tests will monitor eosinophil levels, immune responses, and drug concentrations. The total time in the study can be up to 120 weeks, allowing researchers to observe long-term treatment effects and safety.

This research aims to compare the effects of two inhalers, budesonidealbuterol metered-dose inhaler BDA MDI and albuterol sulfate metered-dose inhaler AS MDI, both used as needed, in adolescents aged 12 to 17 years with asthma. The study focuses on their impact on the annual rate of severe asthma attacks in participants who have a documented diagnosis of asthma and at least one severe exacerbation in the past year. This is a randomized, double-blind, multicenter Phase IIIb trial. Participants are randomly assigned in equal numbers to receive either BDA MDI 160180 micrograms 2 puffs of 8090 micrograms or AS MDI 180 micrograms 2 puffs of 90 micrograms as needed, alongside their usual maintenance asthma therapy. The study includes a 7 to 28-day screening period, a 52-week treatment period, and a safety follow-up lasting 7 to 14 days after treatment ends. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered at a separate visit after safety follow-up. During the study, participants will be monitored through regular assessments including lung function tests such as peak expiratory flow, evaluation of asthma exacerbations, and safety checks for adverse events. The main outcome measured is the annualized rate of severe asthma exacerbations over the 52-week treatment. Safety follow-up and pharmacokinetic evaluations will further assess drug concentrations and participant well-being. Overall participation lasts from screening through safety monitoring after treatment completion.

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.

Researchers are evaluating the post-operative complications and the recurrence of hernias in patients undergoing robotic repair of ventral or inguinal hernias using the OviTex reinforced tissue matrix. This single-arm study focuses on understanding the outcomes following this specific surgical mesh treatment. Up to 160 participants will be enrolled across multiple sites to gather comprehensive data on these surgical procedures. All participants will receive the OviTex reinforced tissue matrix as part of their hernia repair surgery using a robotic approach. Different types of OviTex implants may be used depending on the hernia, including OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR. The size of the implant varies by type, with some size limits for certain products. The study does not include a comparison group and focuses solely on patients treated with OviTex. Participants will be monitored for early and late surgical site occurrences and wound-related events, as well as post-operative complications within the first three months and beyond. Patient-reported outcomes such as quality of life and pain will be assessed up to 24 months after surgery. Hernia recurrence will also be evaluated at 90 days and at 12 and 24 months post-operation. The study involves follow-up visits and questionnaires to track these outcomes over time, with participation lasting up to two years.