Sumy

Researchers are evaluating sodium zirconium cyclosilicate SZC to treat hyperkalaemia in children under 18 years old. This Phase 3, international, open-label study aims to assess the effectiveness, safety, and tolerability of SZC. The study enrolls about 140 children from multiple countries, starting with age groups 6 to under 12 years and 12 to under 18 years. Later, younger age groups may be included based on data reviews. The goal is to see how well SZC controls potassium levels in children with this condition. The study includes three treatment phases Correction Phase CP, Maintenance Phase MP, and Long-Term Maintenance Phase LTMP. In the CP, participants receive fixed doses of SZC orally three times daily for up to 3 days until potassium levels normalize. Doses are adjusted based on body weight and age groups, with possible dose increases after safety reviews. Those who achieve normal potassium enter the 28-day MP with once daily SZC, where doses can be adjusted to maintain potassium levels. Participants may continue in the LTMP using the same dosing approach with monthly visits. Participants undergo regular monitoring including blood tests, urine tests, and ECGs to assess potassium levels, electrolytes, and heart rhythm. Researchers track safety, tolerability, potassium control, and other biochemical changes throughout the phases. The study lasts about 28 weeks, including treatment and a safety follow-up visit one week after the last dose. Data collected will help evaluate SZCs role in managing hyperkalaemia in children.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are evaluating the impact of repetitive tactile stimulation compared to selective stimulation on the oxygen levels of preterm infants born before 32 weeks of gestation. This study uses a stepped-wedge cluster randomized controlled design, where entire centers switch from selective to repetitive stimulation over time. The goal is to see if repetitive stimulation improves oxygenation at 5 minutes after birth, based on prior evidence suggesting it may enhance respiratory effort and reduce the need for invasive support. Initially, participating centers will apply selective tactile stimulation by gently rubbing the infants back, chest, limbs, or soles only if breathing seems insufficient. Later, centers are randomly assigned to switch to repetitive stimulation, involving 10-second gentle rubbing followed by 10 seconds of rest, repeated for the first 5 minutes after birth or longer if needed. All other care procedures in the delivery room and neonatal intensive care unit follow standard guidelines throughout the study. During the trial, infants will be monitored closely with measures including oxygen saturation at 5 minutes after birth, heart rate, and respiratory support interventions such as CPAP and mechanical ventilation during the first minutes and week after birth. Additional assessments include cranial ultrasound and recording of interventions like surfactant administration. The study aims to understand how different tactile stimulation methods affect early oxygenation and respiratory outcomes in very preterm infants, with participation lasting through the first week after birth.