Mendrisio

Researchers are evaluating whether survodutide can help adults with liver diseases called non-alcoholic steatohepatitis NASH or metabolic-associated steatohepatitis MASH who have cirrhosis and a body mass index BMI of 27 kgm2 or higher 25 kgm2 for Asian participants. The study compares survodutide to a placebo to see if it improves liver function and related health outcomes over time. This is a Phase III trial with participants randomly assigned to groups, and it is double-blind, meaning neither participants nor doctors know who gets the medicine or placebo. Participants receive weekly injections of survodutide or placebo under the skin and get regular counseling on diet and exercise. The study lasts up to four and a half years, with visits either in person or via video call every 2, 4, or 6 weeks for about 17 months, then every 3 months thereafter until the study ends. The study collects health data including body weight, liver imaging results, and symptom questionnaires to assess the treatment effects. During the study, doctors monitor participants health and record any side effects. Liver health is checked using imaging methods at certain visits, and participants fill out questionnaires about their symptoms. The primary outcome measures include time to serious liver-related events and overall survival. Secondary outcomes look at changes in liver fibrosis, body weight, blood sugar control, liver stiffness, and other blood markers. The study aims to provide detailed long-term information on survodutides impact on liver disease and safety.

Researchers are evaluating survodutide, a medicine given by weekly injection, in adults aged 18 and older who have obesity and a liver disease called non-alcoholic steatohepatitis NASH or metabolic associated steatohepatitis MASH with moderate or advanced liver fibrosis. The study aims to see if survodutide can improve liver function and slow disease progression. This Phase III trial compares survodutide to a placebo, with participants randomly assigned to one of the two groups, and neither participants nor doctors know who receives which treatment. Participants inject survodutide or placebo under their skin once a week, with doses gradually increasing to a target level. All participants also receive counseling to encourage diet changes and regular exercise. The study has two parts the first focuses on the effect of survodutide on liver fibrosis and MASH over 52 weeks, and the second assesses long-term safety and effectiveness up to 7 years. Participants are involved for up to 7 years, with visits to the study site or remote video calls starting every 2 weeks, then every 4 and 6 weeks, and eventually alternating every 3 months. During visits, doctors monitor health, weight, and digestive effects, perform liver imaging, and collect liver tissue samples at select times. Participants complete questionnaires about symptoms and quality of life. Researchers measure changes in liver disease markers, body weight, blood tests, and monitor safety and serious outcomes like progression to cirrhosis or liver-related events.

Researchers are evaluating the performance of the Gynecare TVT ABBREVO4 Continence System in women undergoing mid-urethral sling surgery to treat Stress Urinary Incontinence SUI. This observational, post-market clinical study focuses on long-term follow-up to assess the systems impact on continence over approximately 5 to 10 years after surgery. Participants undergo surgical treatment for SUI using the Gynecare TVT ABBREVO4 device as part of standard care. There is no additional intervention in the study beyond the usual surgical procedure and clinical care. The study follows participants from the time of surgery through long-term follow-up lasting about 10 years. During the study, participants will be monitored with assessments including the Cough Stress Test CST to evaluate continence status, patient-reported improvement measures, urinary incontinence questionnaires, sexual function questionnaires, and pain rating scales. Follow-up involves regular evaluations through the study completion date to track outcomes and safety over the long term.

This research aims to understand how thyroidectomy removal of the thyroid gland complications may differ depending on the thyroid hormone levels before surgery in patients with Graves disease or Amiodarone-induced thyrotoxicosis AIT. It focuses on whether patients with different thyroid metabolic statescontrolled normal hormone levels or uncontrolled elevated hormone levelshave similar rates of complications such as nerve damage, hypoparathyroidism, bleeding, or severe heart events during and after surgery. The study is observational and uses data collected in the EUROCRINE registry from multiple centers in Europe. Patients who undergo thyroidectomy for Graves disease or AIT are grouped based on their hormone levels before surgery, using free triiodothyronine fT3 and free thyroxine fT4 tests taken within one week prior to surgery. The study does not alter the surgery or treatment methods. Data are collected prospectively through the EUROCRINE registry and an additional module for study-specific routine data. The study plans to include about 25 centers over two years and will record details such as surgery duration, blood loss, medications, monitoring techniques, hospital stay, and any complications. Participants will provide informed consent, and their usual surgical care is not changed. Researchers will track outcomes from the day of surgery through an average of two years, including complications and recovery. Data include clinical information, operative details, and postoperative follow-up. The study aims to help refine surgical guidelines and determine if waiting for normal thyroid levels before surgery is necessary, potentially speeding up treatment and reducing risks and costs for patients.

Researchers are conducting a first-in-human Phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BAR502 in healthy adults aged 18 to 55 years. This study includes two parts Part A is a randomized, double-blind, placebo-controlled trial with single ascending doses, while Part B is an open-label study with multiple ascending doses based on safety information from Part A. The study is designed to understand how BAR502 behaves in the body and its effects at different doses. In Part A, participants will receive a single oral dose of BAR502 or a matching placebo in one of four dose levels. Part B involves two cohorts receiving multiple daily doses of BAR502 for 14 days, with dose levels chosen from Part As results. BAR502 tablets will be taken in the morning after fasting, and placebo tablets will be given similarly in Part A. The study uses a dose-escalation approach to assess increasing doses safely. Participants will be monitored closely with assessments including vital signs, physical exams, laboratory tests, and electrocardiograms. Blood and urine samples will be collected at specified time points to measure drug levels and biomarkers. Safety will be tracked through adverse event reporting and changes in heart rate, blood pressure, and liver function tests. The study duration includes dosing days and follow-up visits up to Day 30 to ensure thorough evaluation of safety and drug effects.