Mendrisio

Researchers are evaluating the effects of survodutide in adults aged 18 years and older who have a confirmed liver condition called non-alcoholic steatohepatitis (NASH) or metabolic-associated steatohepatitis (MASH). Eligible participants must have a body mass index (BMI) of 27 kg/m2 or higher, or at least 25 kg/m2 if they are Asian. The study excludes those with other chronic liver diseases or a history of significant alcohol use. The main goal is to see if survodutide can improve liver function and delay progression of liver damage over time. Participants are randomly assigned to receive either survodutide or a placebo, with twice the chance of receiving survodutide. Both treatments are given as weekly injections under the skin using a pre-filled syringe. Alongside treatment, all participants receive regular counseling to encourage healthy diet and exercise habits. The study lasts up to four and a half years, with frequent visits or remote video calls during the first year and five months, then quarterly visits thereafter. During the study, doctors monitor participants' health, including body weight and liver function using imaging tests at certain visits. Participants complete symptom questionnaires to help assess their condition. Researchers track outcomes such as survival, need for liver transplant, worsening liver disease, and liver-related complications. Safety and any side effects are closely watched throughout the study period to understand the treatment's impact.

Researchers are evaluating the effects of survodutide on adults living with obesity who have a liver disease called non-alcoholic steatohepatitis (NASH) or metabolic associated steatohepatitis (MASH), along with moderate or advanced liver fibrosis. The study focuses on whether survodutide can improve liver function and reduce liver damage in these participants. This Phase III trial aims to assess both the effectiveness and safety of survodutide over a long-term period. Participants are randomly assigned to one of two groups: one receiving weekly injections of survodutide and the other receiving placebo injections that look like the medicine but contain no active drug. The doses of survodutide are gradually increased until the target dose is reached. All participants receive counseling to support healthy diet changes and regular exercise throughout the study. The study lasts up to 7 years, with frequent visits to the study site or remote video calls. In the first year, visits occur every 2 weeks, then every 4 to 6 weeks, and later every 3 months alternating between in-person and remote. Throughout the study, researchers monitor participants' health, liver condition through imaging and biopsies, body weight, digestive system effects, and questionnaires about symptoms and quality of life. The main outcomes include liver fibrosis improvement, resolution of MASH without worsening fibrosis, and long-term safety and efficacy measures.

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 post-market clinical study focuses on women diagnosed with SUI confirmed by a positive cough stress test. The study aims to assess the long-term outcomes and safety of this continence device for surgical correction of SUI. Participants will undergo surgery using synthetic sub-urethral vaginal slings, which is the standard of care for treating primary stress urinary incontinence without additional prolapse surgery. There is no experimental intervention beyond the usual surgical procedure and clinical care. The study is designed as a single-arm follow-up to observe the device's performance over time. During the study, women will be monitored from post-surgery through follow-up visits spanning approximately 5 to 10 years. Researchers will assess changes using the Cough Stress Test (CST) to evaluate improvements in urinary incontinence. Participants will complete questionnaires and attend regular visits to track their condition and any safety concerns. The study emphasizes long-term observation to understand the continence system's sustained effectiveness and safety.

Researchers are investigating the differences in complications during and after thyroid removal surgery (thyroidectomy) in patients with thyroid overactivity caused by Graves' disease or Amiodarone-induced thyrotoxicosis (AIT). The study aims to determine whether patients undergoing surgery have similar complication rates depending on their thyroid hormone levels before or during the operation. This prospective observational trial uses data collected in the EUROCRINE registry to better understand risks and potentially improve treatment guidelines for these conditions. Participants will undergo thyroidectomy as part of their usual clinical care without changes to their treatment before or after surgery. Patients are grouped based on whether their thyroid hormone levels are controlled (normal) or uncontrolled (elevated) prior to surgery, assessed using free triiodothyronine (fT3) and free thyroxine (fT4) tests done within one week before the procedure. The study will include approximately 25 centers across Europe, with data collected securely online through the EUROCRINE registry and an add-on module for study-specific information. During the study, researchers will collect detailed information on surgical complications such as nerve injury, low calcium levels, bleeding, and severe heart events, along with surgery duration and hospital stay length. Data on preoperative medications and monitoring techniques will also be recorded. Participants will be followed for an average of two years after surgery to observe any complications. The findings aim to clarify if surgery can proceed safely without waiting for thyroid hormone levels to normalize, potentially reducing wait times and risks from prolonged hormone imbalance.

Researchers are conducting a Phase I clinical trial to study the safety, tolerability, pharmacokinetics, and pharmacodynamics of BAR502 in healthy adults aged 18 to 55 years. This first-in-human, single-center study is divided into two parts: Part A is a randomized, double-blind, placebo-controlled, single ascending dose study, and Part B is an open-label, multiple ascending dose study. The trial aims to carefully evaluate how BAR502 is processed in the body and its effects at different dose levels. In Part A, participants receive single oral doses of BAR502 or placebo as film-coated tablets after overnight fasting, with doses planned at 3, 10, 30, and 60 mg. Part B involves administering two multiple ascending doses of BAR502, selected based on Part A results, once daily for 14 days to two groups of 10 subjects each. All treatments are given orally in the morning with water, following strict timing and dosing schedules. Participants will undergo regular safety assessments including monitoring for adverse events, vital signs such as blood pressure and heart rate, and clinical laboratory tests. Measurements occur at multiple time points including before, during, and after dosing periods in both study parts. Researchers will also check for drug tolerance and bodily responses throughout the study. The total participation involves close observation to assess both single and repeated doses of BAR502 in healthy volunteers.