Zaporizhzhia

This research aims to assess the physical impact of Multiple Sclerosis MS from the participants perspective. It also provides participants continued access to the medication ocrelizumab while evaluating its safety and tolerability. The study is an open-label extension phase 3 trial sponsored by Hoffmann-La Roche, focusing on patients previously enrolled in related studies who currently lack local access to ocrelizumab treatment. Participants will receive ocrelizumab either as a 600 mg intravenous infusion or a 920 mg subcutaneous injection, following the dosing schedule established in their prior parent study. Treatment will continue until local access to the drug becomes available, if safety concerns arise, if the participant withdraws consent, or in the event of death. During the study, participants will be monitored for changes in physical functioning using patient-reported outcome measures over up to five years. Researchers will also track the number of participants receiving ocrelizumab and monitor adverse events, including serious or special interest events that may lead to discontinuation. Safety and tolerability assessments will continue throughout the study duration, which may last up to five years.

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.

Researchers are evaluating a cervical cancer screening program using self-sampling for human papillomavirus HPV detection among women aged 30 to 60 years in the Zaporizhzhia region of Ukraine. This area has faced disruption due to armed conflict, which has affected traditional access to preventive services. The study aims to improve screening access, assess the feasibility of self-sampling in conflict conditions, and support the development of a sustainable cervical cancer control model applicable to similar challenging settings. The project is a collaboration between local Ukrainian institutions and Karolinska Institutet in Sweden, supported by an international cancer control organization. Participants receive an HPV self-sampling kit distributed through primary care providers, community outreach, or partner organizations. Women collect a vaginal sample themselves using the provided FLOQSwab device and return it to clinics or volunteers free of charge. Samples undergo testing for high-risk HPV types in accredited molecular laboratories with quality assurance processes. HPV-positive women receive follow-up care according to national guidelines, including referral for further examination and treatment if needed. HPV-negative women are reassured and advised on future screening intervals. The study also includes training for healthcare providers and uses a secure digital platform to manage registrations, results, and follow-up coordination. During the study, participants will be evaluated on their acceptance of self-sampling and follow-up procedures. Data will be collected on participation rates, test results, and adherence to follow-up care. Surveys and interviews with both participants and healthcare providers will assess the programs feasibility, acceptability, and sustainability amid ongoing conflict challenges such as migration and disrupted health services. The primary outcome is the uptake of HPV self-sampling within 12 weeks, with additional outcomes measuring provider adoption, test performance, and follow-up completion. The study is expected to last up to 24 months, aiming to reach about 1,000 eligible women.

This research aims to collect real-world data on the characteristics, management, healthcare use, and outcomes of patients living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It is an international observational registry that includes patients from many countries to better understand how these conditions are treated in everyday clinical practice. Participants in this registry are observed without receiving experimental treatments. Data are collected both retrospectively and prospectively using a cloud-based electronic case report form accessible to investigators and a scientific committee. The registry includes groups of patients with type 2 diabetes, hypertension, chronic kidney disease, or heart failure, either as their primary condition or as a coexisting condition. Patients provide information about their health status, treatments, and outcomes over time. Researchers collect data on demographics, disease characteristics, laboratory tests, treatments, healthcare visits, hospitalizations, and lifestyle factors. The study measures many outcomes such as blood sugar levels, kidney function, heart function, medication use, and health events over an average of three years. Participation is voluntary and ongoing, with data collection continuing until the study end date in 2030.

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 use of the Abdominal Aortic and Junctional Tourniquet - Stabilized AAJT-S device as a temporary treatment for severe postpartum hemorrhage PPH caused by uterine atony that does not respond to standard therapies like uterotonics and balloon tamponade. This multicenter, prospective study focuses on women experiencing heavy bleeding after childbirth in settings where surgical care and blood products may be delayed, such as conflict-affected regions in Ukraine. Participants will receive standard care for PPH initially. If bleeding continues uncontrolled, the AAJT-S device will be applied to the upper abdomen and inflated to 250 mmHg to temporarily block blood flow through the abdominal aorta and inferior vena cava. This device will be used for up to 60 minutes to reduce bleeding and provide time to prepare for surgery and blood transfusion. During the study, women will be closely monitored from device application until six weeks postpartum. Researchers will measure how quickly bleeding is controlled after device use and watch for any device-related side effects. Blood loss will also be estimated visually from delivery until the device is placed. This monitoring aims to assess the devices feasibility, safety, and effectiveness as a temporary intervention for severe PPH.