Sumy

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.

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.

Researchers are evaluating how repetitive tactile stimulation compared to selective stimulation affects oxygen levels in premature infants born before 32 weeks of gestation. This stepped-wedge cluster randomized controlled trial focuses on the behavioral aspect of tactile stimulation performed by clinicians at birth. The goal is to see if repetitive stroking of the feet and back improves the baby's breathing and oxygenation shortly after birth. At the beginning of the study, each participating center will use selective tactile stimulation, gently rubbing the infant only if breathing seems insufficient. Later, centers will switch to repetitive stimulation, where clinicians gently rub the baby's back, chest, extremities, or soles of the feet for 10 seconds followed by 10 seconds of rest. This pattern will continue for the first 5 minutes of life or longer if needed. The study compares these two approaches to see which better supports oxygen levels. During the study, researchers will monitor the infant's oxygen saturation to check if it reaches 80% or higher at 5 minutes after birth. They will track respiratory effort and other clinical outcomes related to breathing support. Participation involves careful observation of the infant's response to tactile stimulation during these early minutes, with continued monitoring as needed to ensure safety and effectiveness.