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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Extreme heat events can cause serious health problems, particularly for people living in communities with limited access to cooling, transportation, or social support. This research evaluates the HEATwise program, a heat preparedness initiative aimed at helping older adults, Tribal members, and people facing housing or economic challenges in Lake County, California. The study includes a pilot phase to test the program's feasibility and a larger trial to measure its effects on heat-related symptoms and resilience over time. The HEATwise program lasts 12 weeks and includes group workshops about heat risks and preparedness, personalized resource navigation, a community celebration, and distribution of cooling and emergency supply kits. In the pilot phase, about 60 participants at three community sites will take part. The full trial will randomly assign eight sites to start the program immediately or after a delay, focusing on increasing protective behaviors and reducing heat-related symptoms over 12 months. Participants will be adults living in Lake County who can communicate by phone and provide a secondary contact. The study will track changes in heat-related symptoms three months after the program, along with other protective behaviors and resilience measures. Researchers will monitor participation, collect feedback, and follow participants for a full year to understand the program's impact and safety.
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.