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Found 3 Actively Recruiting clinical trials
Actively Recruiting
This research is evaluating a one-year version of the Parent-Child Assistance Program (PCAP-1), a home visitation and case management program designed to support parents who have used substances during pregnancy or postpartum. The study aims to assess PCAP-1's effectiveness in preventing the need for foster care, promoting reunification of children with their parents, supporting parent recovery, and connecting parents with community resources. The project is supported by public and private partners including the Oklahoma Department of Human Services and focuses on serving low-income families with high child welfare involvement. The intervention involves case managers working closely with parents over one year, meeting biweekly in homes or community settings. These case managers help parents set and achieve personal goals, provide emotional support, and connect them to recovery services and community resources tailored to their needs. The study will recruit 40 participants for the one-year PCAP-1 program, while a control group will be formed using administrative data from the Oklahoma Department of Human Services. Case managers will maintain caseloads of about 20 participants each to provide individualized support. Participants will be monitored through surveys administered at baseline, 12 months, and 18 months to collect data on behavior, social support, mental health, and parenting. Case managers will complete regular reports on substance use, child custody, family planning, and related social factors every 6 months and monthly. The study will also use child welfare administrative data to track child removals, foster care placements, and reunifications. The primary outcomes measured after one year include the proportion of children not placed in foster care, parent custody status, and reductions in costs to state agencies.
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.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of two treatments for head lice infestation: Elimax Green Lotion Emogreen and Walgreens Lice Killing Shampoo. This study involves individuals aged 6 months and older, of all genders, who have a confirmed diagnosis of head lice. The trial aims to confirm the clinical performance and safety of Elimax Green Lotion with Emogreen, a product that works by physically suffocating and dehydrating lice and their eggs using a bio-alkane and beeswax. Both treatments will be compared to see how well they work and how safe they are for participants. Participants will be randomly assigned to receive either Elimax Green Lotion with Emogreen or Walgreens Lice Killing Shampoo. For Elimax Green Lotion, the lotion is applied to dry hair, saturating the scalp and hair, left for 10 minutes, then washed out with shampoo before combing out lice and eggs. This process can be repeated for 7 to 10 days if lice remain. For Walgreens Lice Killing Shampoo, the shampoo is applied thoroughly to dry hair, left for 10 minutes, then rinsed and combed to remove lice and eggs. Both treatments include combing with a lice comb and instructions to prevent re-infestation. During the study, participants will have their head lice infestation monitored from enrollment through day 10, when the treatment period ends. Researchers will assess cure rates, monitor local and global tolerability, check for skin and eye irritation, and record any adverse events. Participants will be required to attend all follow-up visits and comply with study instructions, including avoiding other lice treatments and hair alterations. Safety and effectiveness data will be collected to help determine the best lice treatment option.