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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

This research aims to evaluate the safety, effectiveness, and how the body processes ferumoxytol for treating iron deficiency anemia IDA in children aged 2 to under 18 years. The study includes male and female pediatric subjects with IDA or those considered at risk of developing IDA by their clinician, regardless of cause, except for those with chronic kidney disease CKD, who are studied separately. Participants will be randomly assigned in a 21 ratio to receive either ferumoxytol or iron sucrose. Ferumoxytol is given as two intravenous doses of 7 mg iron per kg, with a maximum of 510 mg per dose the first dose is on Day 1 and the second dose is 2 to 8 days later. Iron sucrose is given as five intravenous doses of 4 mg iron per kg, with a maximum of 200 mg per dose the first dose is on Day 1 and the remaining doses are given at least once per week and up to three times per week. Participants are monitored for one hour after each infusion. Throughout the study, which lasts up to 5 weeks, researchers will assess hemoglobin levels, check for side effects or adverse events, and perform other safety tests. The main outcome measured is the change in hemoglobin from the start to Week 5. Additional safety assessments include tracking any new or special adverse events up to 49 days after treatment begins.

Age: 2Years - 17YearsAll GendersPhase 3
15 locations
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Actively Recruiting

This study aims to collect prospective safety and effectiveness data for the C-Brace System, a microprocessor-controlled knee ankle foot orthosis, following standard care practices. The research focuses on patients with lower extremity pareses who are fitted with the C-Brace device. The goal is to better understand how the C-Brace influences walking speed, balance, risk of falling, and confidence in balance over time. The C-Brace is a custom-made device with thigh, calf, and foot components connected by an ankle joint or spring element. It uses sensors to continuously monitor knee joint movement and walking phases, adjusting hydraulic resistance and knee motion accordingly. Patients enrolled in the registry will undergo baseline evaluation, fitting, training or therapy sessions, and follow-up visits at 6, 12, 24, and 36 months after fitting. Participants will be assessed through various tests including timed walk tests, balance confidence scores, and mobility assessments at different intervals. The study also tracks falls related to device use and changes in activity levels with an activity tracker. Data collected will help characterize the safety and functional impact of the C-Brace over three years of follow-up.

All Genders
76 locations
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Actively Recruiting

Researchers are studying the long-term effects of aleniglipron, taken once daily, in adults with obesity or overweight who also have weight-related health problems. This Phase 3 global, randomized, placebo-controlled, and double-blind trial aims to evaluate how well aleniglipron works, how safe it is, and how well patients tolerate it over at least 76 weeks. The study also compares aleniglipron with placebo in terms of body weight changes, blood pressure, lipid levels, and patient-reported outcomes. Participants will be randomly assigned to receive one of three doses of aleniglipron or a placebo, all taken orally once daily. Along with the medication, all participants will follow a reduced-calorie diet and increase physical activity. The treatment phase lasts at least 76 weeks, during which effects on weight and other health measures will be assessed. During the study, participants will undergo assessments of body weight, waist size, blood pressure, cholesterol, blood sugar, and quality of life measures from the start through week 76. Researchers will monitor safety and tolerability throughout the treatment period. This long-term study will help understand the impact of aleniglipron on weight management and related health factors over more than a year of treatment.

Age: 18Years - 79YearsAll GendersPhase 3
71 locations