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Actively Recruiting

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.

Age: 18Years +All Genders
2284 locations
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Actively Recruiting

Healthy Volunteer

This research investigates Engaging Together for Healthy Relationships (ETHR) Version 2.0, a program aimed at preventing dating violence among adolescents and their caregivers. The study is a one-arm pilot trial conducted at multiple sites within pediatric primary care settings. It focuses on assessing how acceptable and feasible the ETHR program is when integrated into routine care, as well as exploring potential changes in outcomes before and after the intervention. The intervention includes clinician training and in-clinic resources designed to support caregiver-adolescent relationships. Additionally, families receive follow-up text messages and resources after their pediatric well visits. This program is delivered during these routine healthcare visits, and the trial is expanding to include all providers at two new sites, building on previous pilot work. Participants are involved over several months, with researchers tracking recruitment, consent, and completion rates for surveys and well visits up to three months post-intervention. The study gathers data on participants' views of the program's acceptability, usage of intervention resources after visits, and overall feasibility of delivering this program in pediatric primary care. The total participation period includes baseline assessments, immediate post-intervention surveys, and follow-up surveys at one and three months.

Age: 12Years +All GendersPhase Not Applicable
1 location