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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.
Actively Recruiting
This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.
Actively Recruiting
Researchers are evaluating the safety and tolerability of meropenem-vaborbactam administered by intravenous infusion in children aged 3 months to less than 12 years who have complicated urinary tract infections, including acute pyelonephritis. This phase 2, multi-center, open-label study focuses on children requiring hospitalization and intravenous antibiotic treatment for these infections. The study aims to assess how well this medication is tolerated and to understand its pharmacokinetics in this young population. Participants will receive meropenem-vaborbactam as specified in the treatment arm. In addition, antibiotics may be administered as prescribed by the study physician according to local guidelines and regulations. The treatment period involves at least 7 to 14 days of antibacterial therapy during hospitalization. The study is designed as a single-arm trial, so all participants receive the investigational drug without a comparison group. During the study, researchers will collect urine specimens for culture and monitor participants closely for adverse events up to 28 days. The study includes baseline urine testing before starting treatment and requires confirmation of infection through clinical and laboratory evidence. Safety is the primary outcome, and participants will be evaluated through clinical assessments, laboratory tests, and monitoring of any side effects during and after the treatment period.
Actively Recruiting
Researchers are evaluating the effectiveness of antigravity treadmill training and body weight-supported treadmill training compared to conventional rehabilitation for elderly patients aged 60 to 75 years who have recently undergone hip or knee replacement surgery. The goal is to improve recovery and walking ability after these joint surgeries. The study is a randomized controlled trial conducted at the Rehabilitation Unit of St. Jadwiga Hospital in Trzebnica, involving 60 participants within 3 months after their surgery. Participants will be randomly assigned to one of three groups: antigravity treadmill training, body weight-supported treadmill training, or conventional gait training. The antigravity treadmill uses air pressure to reduce body weight during walking, with gradually decreasing support over 6 weeks, five times per week within a 120-minute daily therapy program. The body weight-supported treadmill uses a harness system to partially unload weight, also for 6 weeks with five weekly sessions. Conventional rehabilitation includes gait training in hospital corridors with assistive devices as needed, plus general exercises, ergotherapy, and physical therapy procedures tailored individually. Participants will be involved in daily therapy sessions for 6 weeks, receiving comprehensive care including kinesitherapy, ergotherapy, and physical therapy under professional supervision. Researchers will measure outcomes using the Western Ontario and McMaster Universities Osteoarthritis Index at the start and after 6 weeks of intervention to assess improvement. Safety and adherence will be monitored throughout the study period.