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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying subpopulations of patients with Autism Spectrum Disorder (ASD) to identify biological and clinical markers that may help determine the best responders to a specific medication. This observational study is conducted internationally across multiple centers and focuses on characterizing different groups within the ASD population. The study aims to improve understanding of ASD subtypes through detailed clinical and molecular analysis. Participants include individuals aged 12 to 65 years who have been previously diagnosed with ASD according to DSM-5 criteria. The study requires access to well-documented health records from the first two years of life and participation involves providing information through parents or reliable caregivers. There are no specific interventions or treatments administered as part of this observational study. During the study, researchers will perform clinical and molecular characterizations of the ASD subpopulations on Day 0. Participants must be free from fever or significant illness within 10 days before assessments. The study observes participants to collect information that can differentiate ASD subgroups, and it monitors for any medical or behavioral conditions that could interfere with study completion.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the Hintermann Series H3 Total Ankle Replacement System, a mobile bearing total ankle replacement device approved by the FDA in 2019. This prosthesis is intended to replace painful arthritic ankle joints caused by primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory diseases such as rheumatoid arthritis and hemochromatosis. The study aims to provide ongoing assurance of the device's safety and effectiveness through required post-approval data submission to the FDA. Participants will receive the FDA-approved Hintermann Series H3 Total Ankle Replacement System, which includes a tibial component, a polyethylene inlay, and a talar component. The device is non-cemented and designed for mobile bearing total ankle replacement. This post-approval study collects data to monitor the device's performance over time. During the study, participants will undergo follow-up visits to assess the device's safety and effectiveness up to five years after implantation. Researchers will monitor primary safety and effectiveness outcomes during this period. Participants will provide health data for evaluation, and the study includes assessments to ensure ongoing suitability and monitor any complications or changes related to the ankle replacement.
Actively Recruiting
Researchers are evaluating whether behavior therapy led by parents can be equally effective when delivered either in person or through telehealth for children with autism spectrum disorder (ASD) who show challenging behaviors. This study focuses on children aged 2 to 7 years old with documented ASD and frequent self-injurious or aggressive behaviors. The goal is to compare the impact of parent-mediated behavioral treatment delivered in two different ways. Caregivers will be coached to provide behavior therapy in weekly 1-hour sessions for 12 weeks. One group will receive coaching in person at home, while the other group will be coached remotely through telehealth technology. In addition, caregivers will complete online psychoeducation modules weekly for 12 weeks. The study involves consistent participation from the same caregiver during scheduled times on weekdays. During the study, researchers will monitor the frequency of challenging behaviors and assess parenting stress every four weeks. Participants will be asked to engage in the therapy sessions and education modules, with clinicians supporting the process either in person or remotely. The total participation time includes these 12 weeks of intervention with regular assessments to understand the effects of the treatment delivery method on child behavior and caregiver stress.