Minden

This research aims to evaluate the effectiveness of a multi-level weight loss intervention called LA-CEAL CONNECT in adults living with obesity in Louisiana. The study will compare this intervention with enhanced usual care to determine if it leads to greater weight loss at 6 months and sustained weight loss at 12 months. It also aims to assess improvements in waist size, diet quality, physical activity, quality of life, and blood pressure, as well as the feasibility of implementing the program in community settings. Participants in the study will be randomly assigned to either the LA-CEAL CONNECT intervention or enhanced usual care. Those in the intervention group will receive culturally tailored educational materials, health coaching from community health workers over 6 months, tools for self-monitoring weight and physical activity using digital devices like a Fitbit and digital scale, and group meetings to connect with community health resources. Both groups will receive educational materials and their healthcare providers will get training and toolkits to support obesity management. During the study, participants will visit clinic sites at the start, 6 months, and 12 months to have clinical measurements and surveys collected. Researchers will monitor weight change as the main outcome at 6 months, along with changes in waist circumference, blood pressure, diet, physical activity, and quality of life. The study will last up to 12 months, with ongoing support and tracking of health behaviors through coaching and digital monitoring devices.

The trial investigates the effectiveness of NeoThelium FT combined with standard care compared to standard care alone in treating diabetic foot ulcers. This open-label randomized controlled crossover study is conducted across multiple medical centers and aims to evaluate wound healing outcomes and pain relief in patients with chronic diabetic foot ulcers. The study includes adult participants with diabetes mellitus who have ulcers that meet specific criteria. Participants are randomly assigned to receive either standard care alone or standard care plus NeoThelium FT, a wound covering made from human placental tissue. Those initially receiving standard care who do not achieve complete wound closure by about 84 days may cross over to the NeoThelium FT treatment arm, receiving weekly applications for up to 12 visits. All participants undergo a two-week screening before randomization. During the study, participants have regular assessments including wound measurements and pain evaluations at specific intervals over 12 weeks. Researchers monitor the percentage of ulcers achieving full closure, wound area reduction, time to closure, and pain levels. The trial supports gathering data for insurance reimbursement decisions and tracks participants through follow-up visits according to the study schedule.

Researchers are evaluating the effectiveness of NeoThelium FT combined with standard wound care compared to standard care alone in treating chronic open wounds. This randomized controlled crossover trial involves patients with chronic open wounds that have not healed sufficiently, aiming to assess wound closure rates within 12 weeks. The study is open label and conducted at multiple medical centers, supporting post-marketing evaluation and insurance reimbursement decisions. Participants will be randomly assigned to receive either standard care alone or standard care plus weekly NeoThelium FT applications. Those initially receiving standard care who do not achieve complete wound closure by about 84 days may cross over to receive NeoThelium FT with standard care for up to 12 additional weekly treatments. Standard care includes wound cleansing, debridement, moisture-balancing dressings, and offloading. Before randomization, participants undergo a two-week screening phase. Throughout the study, wound healing progress and pain levels are regularly assessed, including wound area measurements and pain evaluations at specified time points. The primary measurement is the rate of complete wound closure within 12 weeks, with secondary outcomes assessing wound size reduction and pain. The study duration extends through treatment and follow-up visits, concluding by October 2026.

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.