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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Long-term data on the clinical effectiveness of cochlear implants are limited, and comparing results across different clinics is difficult due to variations in methods. This research collects observational data from children and adults who receive cochlear implants, focusing on systematic and consistent data gathering over time. The study aims to improve understanding by using a standardized approach to track hearing outcomes longitudinally. Participants implanted or to be implanted with a MED-EL cochlear implant system will be included. This is a non-interventional study where each participant receives routine clinical care, and data are collected without changing treatment. The MED-EL CI system includes the cochlear implant and external audio processor used in this study. Participants will have their hearing thresholds, quality of hearing, and auditory development assessed regularly over five years. Data are collected at consistent intervals through a secure cloud-based platform as anonymized records, enabling comparison of hearing progress over time. This long-term monitoring helps researchers evaluate hearing outcomes and auditory development in both adults and children using cochlear implants.
Actively Recruiting
Researchers are conducting an international multicenter prospective observational study to evaluate treatment decisions for patients with symptomatic thoracolumbar fractures caused by primary osteoporosis. The study focuses on postmenopausal women aged 50 and older and men over 60 with radiologically confirmed, single or multilevel contiguous fractures from T1 to L5. These fractures include insufficiency fractures confirmed by MRI and low-energy traumatic fractures confirmed by CT or MRI. The Osteoporotic Fracture (OF) classification system is used to categorize fracture severity from OF 1 to OF 5 to help guide treatment decisions. Patients will be grouped based on whether their initial treatment matches the OF score recommendations: the Accordance group if treatment aligns with the score and the Discordance group if it does not. Treatment options include nonsurgical care or various surgical procedures such as posterior stabilization using pedicle screws, sometimes combined with kyphoplasty, vertebroplasty, screw augmentation, vertebral osteotomy, or anterior stabilization. The initial treatment decision is marked as Day 0, and follow-up treatments may be adjusted based on ongoing OF score assessments. Participants will be followed clinically at hospital discharge, 6 weeks, 3 months, 6 months, and 12 months after treatment begins. The primary outcome is the time it takes for patients to return to their mobility level before the fracture or symptom onset, measured up to 3 months. Secondary outcomes focus on longer-term recovery up to 12 months. Data collected includes clinical evaluations and imaging studies to monitor fracture healing and treatment effects over time.