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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Age: 18Years +All Genders
2270 locations
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Actively Recruiting

Healthy Volunteer

This research aims to evaluate a family-based intervention called Linking Exercise for Advancing Daily Stress (LEADS) Management designed for overweight African American adolescents aged 11 to 16. It addresses the impact of chronic stress on physical activity levels and obesity risk in this group by building coping skills, self-esteem, and positive parenting practices. The study explores how these protective factors may improve engagement in physical activity and overall well-being. The trial compares two groups: one receiving the LEADS intervention, which includes training in mindfulness, deep breathing, active coping, cognitive reframing, self-affirmation, and supportive parenting; and an attention control group receiving comprehensive health education on topics like hypertension, diabetes, cancer, sleep, social media advocacy, metabolism, and financial literacy. The intervention lasts for 10 weeks with group sessions. Participants will be assessed at baseline, after the 10-week sessions, and at a 6-month follow-up. Researchers will measure daily minutes of moderate to vigorous physical activity as the primary outcome. Secondary outcomes include light physical activity, dietary intake, body mass index, waist circumference, blood pressure, adolescent self-regulation, well-being, and coping with stress. The study also evaluates parent outcomes and factors that may influence changes in physical activity.

Age: 11Years - 16YearsAll GendersPhase Not Applicable
2 locations
T

Actively Recruiting

Researchers are evaluating a twice-weekly, moderate intensity exercise and coaching program for adults with mild to moderate cognitive impairment living in South Carolina. The study aims to determine whether the program is practical, acceptable, and enjoyable, and whether participants show changes in endurance, mobility, cognitive function, and perception of cognition at 3, 6, 9, and 12 months. The study is led by the University of South Carolina and focuses on maintaining or improving cognitive and physical abilities. Participants join either an in-person exercise group in Columbia, SC, or a distance exercise group in Sumter, SC. The in-person group attends twice weekly sessions at a fitness center with real-time coaching and feedback, including endurance, strength, balance, and mobility exercises. The distance group receives personalized exercise plans, attends up to seven initial visits with a fitness trainer, and completes the rest of the exercise sessions independently, logging their activity and intensity with support from coaches via phone, text, or email. Throughout the study, participants wear heart rate monitors and have their exercise sessions tracked for intensity, duration, and adherence. Assessments of cognitive function, endurance, mobility, balance, grip strength, and perception of cognition are conducted at baseline and at 3, 6, 9, and 12 months. The main outcomes include feasibility measures like recruitment and adherence, as well as exploratory measures of cognitive and physical function changes over the year-long study.

Age: 18Years +All GendersPhase Not Applicable
2 locations