Westmount

Researchers are studying children and adolescents with acute lymphoblastic leukemia ALL who are in complete remission and require allogeneic hematopoietic stem cell transplantation HSCT. This multinational phase III trial aims to optimize therapy by comparing chemotherapy-based conditioning regimens to total body irradiation TBI combined with chemotherapy. The study focuses on evaluating overall survival and event-free survival, considering the risks of late side effects like organ dysfunction, growth issues, hormonal problems, and secondary cancers from TBI. Participants receive one of several conditioning regimens before HSCT. These include TBI with etoposide VP16 for patients older than 4 years, or chemotherapy combinations such as fludarabine, thiotepa, treosulfan, intravenous busulfan, or busulfan with VP16 and cyclophosphamide, depending on age and donor compatibility. Some patients receive additional medications like ATG Thymoglobulin or Grafalon. The study also stratifies patients by donor type, including matched sibling, matched unrelated, and mismatched donors, to assess outcomes across these groups. During the study, participants undergo regular follow-up for up to 10 years to monitor overall survival, event-free survival, relapse, toxicity, and transplant-related mortality. Data are collected annually starting 18 months after the first patient enrollment. The trial includes assessments of acute and late side effects, with ongoing observation to understand the long-term impact of different conditioning regimens in pediatric ALL patients undergoing HSCT.

Researchers are evaluating the performance and safety of the GT Metabolic Magnet System, a device designed to create side-to-side compression anastomosis in the stomach andor small bowel. The study focuses on adults with gastrointestinal disorders such as partial small bowel obstruction, superior mesenteric artery syndrome SMAS, or gastric outlet obstruction GOO, conditions that involve physical or mechanical blockage of the gastrointestinal tract. These similarities make the Magnet System a potential surgical tool to address these issues as part of clinical treatment. Participants will receive treatment using the GT Metabolic Magnet System, which aims to form a magnetic compression anastomosis for intestinal diversion. The procedure involves placing magnets to create the anastomosis without the immediate need for lumen patency. The study includes monitoring the placement of the magnet on the first day, observing natural magnet passage, and assessing anastomosis patency over a 90-day period. This interventional study does not use blinding or randomization and focuses on the single experimental device. During the study, participants will be closely monitored through evaluations measuring magnet placement and passage, as well as the condition of the anastomosis up to 90 days post-procedure. Researchers will assess safety and device performance. Participants must follow study requirements, including surgical clearance and contraception use if applicable. The total duration includes the initial procedure and follow-up assessments to ensure proper device function and participant safety.

This clinical trial focuses on extremely premature infants born between 25 and 28 weeks of gestation who require immediate breathing support after birth. Researchers aim to compare two methods of providing positive pressure ventilation PPV during the first 10 minutes after birth the manual T-piece resuscitator and a ventilator-delivered PPV V-PPV using nasal intermittent positive pressure ventilation NIPPV. The study seeks to evaluate the impact of these methods on major health complications or death, providing insights to improve care during this critical transition period for these vulnerable newborns. Participants will receive PPV either by a T-piece resuscitator connected to a face mask or by a neonatal ventilator in NIPPV mode connected to a nasal mask or prongs. Both methods will have adjustable settings standardized across study sites. The ventilation support is provided during the first 10 minutes after birth, with each site randomized to use one of the PPV methods. This approach may refine respiratory support and potentially reduce the need for invasive procedures like intubation. During the study, infants will be monitored from enrollment through study completion, up to 50 weeks postmenstrual age. Researchers will assess outcomes including pre-discharge mortality, major neuro-injury, and moderate to severe bronchopulmonary dysplasia BPD. Additional measurements include advanced resuscitation needs, duration of mechanical ventilation, and discharge on home oxygen. The study will track these health outcomes and safety measures to better understand the effects of the PPV methods over time.

This trial investigates adults with obesity and type 2 diabetes, comparing two treatments to improve diabetes control. It evaluates the functional improvement of type 2 diabetes by using the Magnet System in a side-to-side duodeno-ileostomy surgery versus semaglutide medication. Participants have a body mass index between 30 and 40 kgm2 and a hemoglobin A1c level of at least 6.5%. The study is sponsored by GT Metabolic Solutions, Inc. and aims to assess how each treatment affects diabetes over time. Participants are randomly assigned to one of two groups one group receives the Magnet System device to create a duodeno-ileostomy through magnetic compression anastomosis, and the other group receives semaglutide medication as a weekly subcutaneous injection up to 2.4 mg or a dose tolerated based on side effects. The study prohibits additional metabolic or bariatric surgeries and the use of other GLP-1 receptor agonists during the study period. The treatment phase lasts up to one year with assessments scheduled accordingly. Throughout the study, participants will undergo evaluations including measurement of their hemoglobin A1c levels at day 360 to determine functional improvement in diabetes control. Researchers will monitor adherence to treatment, safety, and any side effects. Participants will provide informed consent and comply with follow-up visits and assessments for the full duration of the study, which extends to June 2028.