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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 18Years +All Genders
2368 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating Engaging Together for Healthy Relationships ETHR Version 2.0, a program designed to prevent dating violence between caregivers and adolescents. This pilot trial is conducted in pediatric primary care settings across multiple sites and aims to assess how acceptable and feasible the ETHR program is for families and providers. The study explores preliminary changes in behaviors and attitudes related to adolescent relationship abuse before and after the intervention. The ETHR program includes training for clinicians, provider scripts, resource guides, a take-home box for families, post-visit text messages, a comprehensive website, and warm referral processes. All participants receive this intervention during well-child visits. The trial has one study arm and focuses on delivering the program within routine pediatric care to both providers and families. Participants include adolescents aged 12 to 16 attending well-child visits with a participating provider, along with their caregivers. Throughout the study, researchers track recruitment and consent rates, survey completions at baseline, immediately after the intervention, and at 1 and 3 months post-intervention. They also assess how often families use the provided resources, attitudes and knowledge about adolescent relationship abuse, communication between parents and adolescents, motivation to prevent dating violence, and reports of abuse victimization or perpetration. The study lasts several months, with ongoing surveys and follow-up to monitor program acceptability and impact.

Age: 12Years +All GendersPhase Not Applicable
1 location