Destin

Researchers are evaluating the effectiveness and long-term safety of dupilumab treatment in children aged 2 to less than 6 years who have uncontrolled asthma or recurrent severe asthmatic wheeze. This Phase 3, two-arm study includes a randomized, double-blind, placebo-controlled design to compare dupilumab with placebo in this young population. The study aims to better understand how dupilumab may affect severe asthma flare-ups and monitor safety over an extended period. The study is divided into two parts. Part A lasts up to 68 weeks and includes a 4-week screening period, a 52-week treatment phase where participants receive either dupilumab or placebo by subcutaneous injection, and a 12-week follow-up after treatment ends. After Part A, eligible participants have the option to join Part B, an open-label extension lasting an additional 52 weeks of dupilumab treatment followed by another 12-week post-treatment follow-up. This structure allows researchers to assess both short-term and longer-term effects of dupilumab. Participants will attend clinic visits for assessments throughout the study, where researchers will monitor the number of severe asthma exacerbations during the first 52 weeks and track any adverse events from Week 52 to Week 116. Evaluations include safety checks, questionnaires, and other study procedures to understand treatment impact and tolerability. The total participation duration for each child can be up to 120 weeks, providing comprehensive data on dupilumab's use in young children with asthma or severe wheezing.

Researchers are evaluating the effects of two inhalers, budesonide/albuterol metered-dose inhaler (BDA MDI) and albuterol sulfate metered-dose inhaler (AS MDI), both taken as needed, on reducing severe asthma attacks in adolescents aged 12 to under 18 years who have a clinical diagnosis of asthma and have experienced at least one severe asthma exacerbation in the past year. This is a Phase IIIb randomized, double-blind, multicenter study lasting 52 weeks with a safety follow-up period after treatment. Participants will be randomly assigned to receive either BDA MDI 160/180 micrograms (two puffs of 80/90 micrograms) or AS MDI 180 micrograms (two puffs of 90 micrograms) as needed, alongside their usual asthma maintenance therapy, for 52 weeks. The study includes a 7 to 28-day screening period before treatment and a safety follow-up visit 7 to 14 days after the end of treatment. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered after the safety follow-up. During the study, participants will be monitored for the annual rate of severe asthma exacerbations from randomization to week 52. Assessments include evaluating inhaler technique, peak expiratory flow measurements, and adherence to contraception methods for participants of childbearing potential. Safety will be monitored throughout the treatment and follow-up periods. The total study duration includes screening, 52 weeks of treatment, and safety follow-up.

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.

Researchers are evaluating the post-operative complications and hernia recurrence in people with ventral or inguinal hernias treated using a robotic surgical approach with the OviTex Reinforced Tissue Matrix. This study involves up to 160 participants across about 20 sites and aims to understand the outcomes after surgery using this specific surgical mesh designed to repair or reinforce weakened or missing soft tissue. All participants will receive the OviTex mesh during their robotic hernia repair surgery. Different types of OviTex implants may be used depending on the hernia size, with size limits specified for certain implant types. This is a single-arm study where every subject gets the OviTex device to support the hernia repair. Participants will be involved in the study through surgery and follow-up visits to monitor for early surgical site problems and other post-operative complications occurring within the first three months after surgery. They will complete quality of life and pain questionnaires, and researchers will track wound healing and possible hernia recurrence. The study requires participants to be at least 21 years old and able to comply with all study requirements, including follow-up for up to two years.