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Found 5 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the physical impact of multiple sclerosis (MS) from the participant's perspective while providing continued access to the drug ocrelizumab. This Phase 3 extension study focuses on assessing the safety and tolerability of ocrelizumab, a treatment for MS, at approved doses. The study includes participants who were already receiving ocrelizumab in previous Genentech and/or F. Hoffmann-La Roche Ltd sponsored studies and do not have local access to this treatment through other means. Participants will receive ocrelizumab either by intravenous (IV) infusion at 600 milligrams or by subcutaneous (SC) injection at 920 milligrams, following the dosing schedule from their previous parent study. Treatment will begin no earlier than five months after their last dose in the parent study. This open-label, multicenter extension provides ongoing access to ocrelizumab for up to five years. Throughout the study, participants will be monitored for changes in their physical functioning using the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure for Multiple Sclerosis (PROMISnq PFMS-15a). Researchers will also track the number of participants receiving ocrelizumab during the study and assess safety and tolerability over the long term. Monitoring includes regular evaluations to ensure participant well-being during the extended treatment period.
Actively Recruiting
Researchers are evaluating the safety, effectiveness, and tolerability of sodium zirconium cyclosilicate (SZC) for treating high potassium levels (hyperkalaemia) in children under 18 years old. This Phase 3, open-label international study will enroll about 140 children across roughly 46 sites in Europe, North America, and other locations. Enrollment begins with children aged 6 to under 12 years and 12 to under 18 years, with plans to include younger age groups based on data review. The study aims to assess whether SZC can help children achieve and maintain normal potassium levels safely. Treatment involves three phases: a Correction Phase (CP) where all participants receive SZC three times daily for up to 3 days to reach normal potassium levels; a 28-day Maintenance Phase (MP) where SZC is taken once daily with dose adjustments to keep potassium normal; and an optional Long-Term Maintenance Phase (LTMP) for continued treatment with monthly visits. Younger children receive doses based on body weight equivalent to adult dosing, with dose levels adjusted after safety reviews by an independent committee. During the study, participants will have blood tests, ECGs, and other assessments to monitor potassium levels, electrolyte balance, and safety. Researchers will evaluate the ability to achieve normokalaemia during the CP and maintain it during the MP and LTMP. The study lasts about 28 weeks, including safety follow-up, and will also assess SZC's acceptability and palatability for children.
Actively Recruiting
This research aims to collect real world data on patient characteristics, disease management, healthcare use, and outcomes for people living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It focuses on understanding how these conditions are managed and the quality of care patients receive in everyday clinical practice across many countries. The registry is observational and voluntary, designed to fill gaps in knowledge about these diseases globally. The study uses a multinational, observational registry with a cloud-based electronic case report form (eCRF) to gather both prospective and retrospective data. This system is accessible to doctors managing patients with type 2 diabetes, hypertension, heart failure, or chronic kidney disease worldwide. There are no specific treatments or interventions given as part of this study since it is a data collection registry. Participants provide information for an average of 3 years during the study. Researchers will collect data on patient characteristics, disease management, healthcare use, quality of care indicators, cardiovascular outcomes, kidney outcomes, and other related complications. The registry allows ongoing data entry and monitoring to better understand real world outcomes and care quality for these conditions.
Actively Recruiting
Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.
Actively Recruiting
Researchers are evaluating the use of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device as a temporary treatment for severe postpartum hemorrhage caused by uterine atony that does not respond to standard therapies like uterotonics and balloon tamponade. This multicenter study is conducted in Ukraine, including regions affected by conflict where surgical care and blood products may be limited or delayed. The AAJT-S device is a non-invasive tool applied horizontally over the upper abdomen and inflated to 250 mmHg to temporarily block blood flow through the abdominal aorta and inferior vena cava. This aims to control bleeding and provide time to prepare for surgery, blood transfusion, and anesthesia. The device will be used for up to 60 minutes following confirmation that standard treatments have failed. Participants are postpartum women aged 18 to 50 years with significant blood loss exceeding 1300 mL despite initial treatments. Researchers will measure how quickly bleeding is controlled within 5 minutes of device application and monitor safety by tracking any device-related adverse events throughout the treatment and up to six weeks after delivery. The study includes informed consent and follow-up visits to assess outcomes and safety over time.