Hyde Park

Researchers are studying dulaglutide, a medication given by injection under the skin, to explore new dosing options for children and teenagers aged 10 to under 18 years with Type 2 Diabetes. This phase 3 trial focuses on evaluating the safety of dulaglutide doses 3.0 mg and 4.5 mg in pediatric participants who have Type 2 Diabetes managed with diet, exercise, and stable doses of metformin andor basal insulin. The study is sponsored by Eli Lilly and Company and aims to better understand how dulaglutide works in this younger population. Participants will receive dulaglutide subcutaneously, with no placebo group as this is a single-group study. The study treatment will be administered over a period of about eight months. Throughout the study, researchers will closely monitor the number of serious side effects that might be related to the drug. Additional evaluations will include measuring dulaglutide levels in the blood over time, changes in blood sugar control Hemoglobin A1c, body weight, cholesterol levels, quality of life assessments, and beta cell function. During the study, participants will attend visits where blood samples and other health assessments will be performed at specific times including baseline, week 26, and week 30. Researchers will use these assessments to track the medications impact and monitor for safety. Participation involves regular monitoring over approximately eight months, allowing researchers to collect important data on how dulaglutide affects young people living with Type 2 Diabetes.

The trial investigates the safety and effectiveness of Voyager Biomedicals Access Device designed to help patients undergoing routine hemodialysis by facilitating the cannulation of arteriovenous fistulas AVFs. This pivotal, interventional, single-arm, open-label study aims to support FDA clearance of the device by assessing its ability to improve access during dialysis and ensure patient safety. The study addresses challenges where AVFs are difficult to cannulate due to depth or accessibility issues and evaluates the device as a potential alternative to other surgical methods. Participants will have the VenaSure device surgically implanted at the dialysis access site, tailored to their clinical needs. Depending on vascular access conditions, one or two devices may be implanted to assist arterial andor venous cannulation. After implantation, patients will be observed for 6 weeks to allow healing. Following this, they will be monitored for 36 months while undergoing routine hemodialysis to assess the devices long-term performance and safety. During the study, participants will have regular follow-up visits to monitor healing, device function, and any adverse effects. Researchers will collect data on the devices ability to facilitate cannulation at 6 months and evaluate safety outcomes at 12 months and beyond. The study lasts approximately 48 to 60 months from enrollment until data collection is complete. Patients exit the study after the final visit with no ongoing device-related safety concerns.

Researchers are conducting a long-term observational study called ATHN Transcends to better understand non-cancerous blood disorders. This study follows participants with various hematologic conditions, including hemophilia, von Willebrand Disease, congenital platelet disorders, rare bleeding disorders, thrombosis, and other related conditions. The aim is to collect uniform and high-quality data on the safety, effectiveness, and treatment practices of new and existing therapies over many years, addressing gaps beyond initial clinical trials and real-world treatment outcomes. Participants are assigned to specific cohorts based on their diagnosis, such as Hemophilia, Congenital Platelet Disorders, and others. Within these cohorts, there are multiple study arms and modules focusing on different therapies or disease aspects, including gene therapy outcomes and product-specific data collection. Data is gathered through scheduled assessments at enrollment, every six months, annually, and as needed, with follow-up planned for a minimum of 15 years. The study also includes a biorepository for collecting biological samples to support current and future research. Throughout the study, participants provide information during regular visits, and data is collected about their medication use, bleeding events, and treatment effectiveness. Researchers monitor safety and treatment outcomes continuously to better understand long-term effects. The study involves comprehensive evaluations but does not involve administering treatments instead, it observes participants receiving usual care. Participants may remain in the study for many years, contributing to a valuable resource that helps improve understanding of blood disorders and their management.