Gouda

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating the safety and effectiveness of BGB-16673 compared to pirtobrutinib in adults with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who have previously been treated with a covalent Bruton tyrosine kinase inhibitor cBTKi. The study is a phase 3, open-label, randomized trial sponsored by BeOne Medicines, aiming to assess treatment options for these patients. Participants are randomly assigned to receive either BGB-16673 or pirtobrutinib, both taken orally. This parallel assignment design compares these two drugs directly. The treatments continue with monitoring up to approximately three years to observe progression-free survival and other outcomes. The study began in September 2025 and is expected to complete in April 2028. During the trial, participants will undergo regular assessments including imaging scans to measure disease status, quality of life questionnaires, and monitoring for adverse events. Outcomes such as overall survival, response rates, duration of response, and time to next treatment are tracked. Safety and quality of life will be evaluated throughout the study period, which may last up to about three years for each participant.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating two surgical methods of distal gastric bypass DGB as revisional surgery for patients who have had insufficient weight loss or weight regain after Roux-en-Y gastric bypass RYGB. This multicenter randomized controlled trial aims to determine which DGB technique is better for total weight loss and managing protein calorie malnutrition. The study involves morbidly obese patients eligible for distalisation surgery, addressing a gap in consensus for optimal surgical approaches after failed RYGB. Participants will be randomly assigned to one of two groups DGB type I, which involves lengthening the biliopancreatic limb by modifying the Roux limb and reattaching it further along the intestine, or DGB type II, which lengthens the alimentary limb by dividing and reattaching the biliopancreatic limb. Both procedures are performed laparoscopically. The trial includes follow-up visits at 1.5, 3, 6, 12, 18, 24, and 36 months after surgery to monitor outcomes. During the study, participants will undergo regular clinical and outpatient assessments including weight measurements, evaluation of protein calorie malnutrition, defecation patterns, nutritional deficiencies, and quality of life questionnaires. Researchers will track weight loss and malnutrition treatment needs primarily at one year post-surgery, with additional secondary outcomes assessed up to three years. Patient satisfaction and eating behavior will also be evaluated throughout the follow-up period. The total participation spans up to three years to thoroughly assess long-term effects and safety.

Researchers are evaluating chemotherapy dosing strategies in older patients aged 70 years and above who have metastatic colorectal cancer and are eligible for first-line palliative chemotherapy. This phase III randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy, focusing on progression-free survival PFS. Patients are assessed using the Geriatric 8 G8 questionnaire to determine their risk of chemotherapy toxicity, which guides treatment assignment. The study seeks to balance treatment effectiveness with minimizing toxicity, hospital admissions, and maintaining quality of life QoL and physical functioning. Participants classified as low risk for toxicity G8 score 15 or higher are randomized to receive either doublet chemotherapy a fluoropyrimidine combined with oxaliplatin at full dose or with a 25% dose reduction upfront. Those at high risk G8 score 14 or lower or judged high risk by their oncologist receive fluoropyrimidine monotherapy either at full dose or with a 25% dose reduction. The study also allows the addition of targeted treatments like bevacizumab or EGFR inhibitors. Dose adjustments are made for patients with moderate kidney impairment. Chemotherapy is given orally or intravenously on schedules varying between every two and three weeks, depending on the regimen. Participants will be closely monitored throughout treatment, with assessments including radiological or clinical evaluations for disease progression, quality of life and physical functioning questionnaires at 1, 3, 6, and 12 months, and tracking of chemotherapy toxicity, overall survival, treatment cycles, dose changes, hospital admissions, and cumulative drug dosage. Safety and cost-effectiveness will also be evaluated over an average study duration of eight months and up to one year for some outcomes. The study plans to include 587 patients and will continue until December 2028.

Researchers are investigating whether skipping the usual follow-up surgery called re-excision after removing primary cutaneous melanoma affects patient outcomes. This large, phase III trial involves 1,749 patients with melanoma stages pT1b to pT4b who have no signs of metastases. The study compares relapse-free survival between those who receive standard re-excision and those who do not, while also examining overall survival, recurrence rates, surgical side effects, quality of life, and economic impact. Participants are randomly assigned to either undergo re-excision surgery with margins of 1 to 2 centimeters according to local guidelines or to receive no further surgery after the initial tumor removal. Sentinel lymph node biopsy and additional systemic treatments are given as needed in both groups. Re-excision, if performed, occurs within 12 weeks of the first surgery and follows standardized procedures to ensure clear margins. Patients will be monitored for up to five years to track recurrence and other outcomes. During the study, patients will have regular follow-ups including assessments of cancer recurrence, surgical complications, and quality of life using validated questionnaires at various time points up to two years. Health economic data will also be collected to evaluate cost-effectiveness. The main measure is relapse-free survival over five years, with additional measures including overall survival and different types of melanoma recurrence. Safety and quality of life are carefully tracked, with management of recurrences left to treating physicians throughout the study period.

Researchers are evaluating the best rehabilitation method for patients who have suffered Displaced Intra-articular Calcaneal Fractures DIACFs, which are fractures involving the heel bone often requiring surgery. This study aims to compare two rehabilitation protocols Permissive Weight Bearing PWB and Restricted Weight Bearing RWB, focusing on functional outcomes, quality of life, radiographic differences, cost-effectiveness, and complications. The trial is a multi-center randomized controlled study involving patients aged 18 to 67 years who have undergone surgical fixation for DIACFs. Participants are randomly assigned to one of two rehabilitation groups. The PWB group starts weight bearing about two weeks post-surgery after wound healing, progressing according to patient comfort and pain with guidance from therapists and physicians. They follow milestones such as walking with crutches or canes with recordings of progress. The RWB group follows standard AO guidelines with 8 to 12 weeks of minimal weight bearing 0-10%, gradually increasing weight bearing by 25% weekly after 8 weeks. Both protocols include detailed records of weight bearing advice throughout treatment. During the study, participants will be assessed at 0, 2, 6, 12 weeks, and 6 months after surgery. Researchers will measure functional outcomes using the AOFAS questionnaire, foot function scores, daily living activities, quality of life surveys, and radiographic parameters like Bhlers angle. Costs and complications will also be tracked. Follow-up visits align with current trauma guidelines and include clinical evaluations and imaging, with radiation exposure consistent with standard care. The total study duration allows for comprehensive monitoring of recovery and rehabilitation effects.