Gouda

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

This research aims to evaluate 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. The goal is to better understand treatment options for patients whose disease has returned or did not respond to earlier therapies involving cBTKi. Participants will receive either BGB-16673 or pirtobrutinib, both given orally. The study compares these two treatments to assess their safety and efficacy. The treatment period and dosing details are managed as per the trial protocol to evaluate the outcomes of each drug. The study includes ongoing monitoring and assessments to observe treatment effects over time. During the study, participants will be closely followed for up to approximately 3 years to measure progression-free survival, as assessed by an independent review committee. Researchers will conduct regular evaluations including imaging and laboratory tests to track disease status and safety. Participants' health will be monitored throughout the study to identify any side effects or changes in condition.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

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 compare DGB with lengthening of the biliopancreatic limb (BPL) and DGB with extension of the alimentary limb (AL) to find the optimal surgical technique for additional weight loss and to assess the need for treatment of protein calorie malnutrition (PCM). The study involves morbidly obese adults aged 18 to 65 years who have failed to achieve sufficient weight loss following primary RYGB. Participants will be randomly assigned in equal numbers to one of the two surgical groups: DGB type I with lengthening of the BPL, or DGB type II with extended AL. The trial will be conducted across multiple bariatric centers with procedures performed in both clinical and outpatient settings. Follow-up visits will occur at 1.5, 3, 6, 12, 18, 24, and 36 months after surgery to monitor outcomes. During the study, participants will undergo regular assessments including weight measurements and monitoring for protein calorie malnutrition. Researchers will evaluate total weight loss one year after the surgery and the development of PCM requiring treatment. Additional outcomes include weight loss over time, remission of obesity-related conditions, nutritional deficiencies, quality of life, patient satisfaction, morbidity, and mortality. Participants must agree to a follow-up program and complete questionnaires throughout the study period.

Researchers are evaluating chemotherapy dosing strategies for older patients aged 70 years and above who have metastatic colorectal cancer and are candidates for palliative chemotherapy. This phase III, open-label, randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy to see if the reduced dose is not worse in terms of progression-free survival (PFS). The study also examines secondary outcomes including severe toxicity, quality of life, physical function, overall survival, treatment cycles, dose reductions, hospital admissions, cumulative dosage, and cost-effectiveness. Participants are classified based on their risk of chemotherapy toxicity using the Geriatric 8 (G8) questionnaire. Those at low risk are randomized to receive either full-dose or 25% dose-reduced doublet chemotherapy (a fluoropyrimidine combined with oxaliplatin). Patients at high risk receive either full-dose or dose-reduced monotherapy with a fluoropyrimidine. Targeted treatments like bevacizumab or EGFR inhibitors may be added. Dose adjustments are made for moderate kidney impairment. Treatments are given on schedules involving oral and intravenous chemotherapy drugs administered every 2 to 3 weeks. During the study, participants undergo assessments including clinical evaluations, laboratory tests to monitor blood counts and organ function, and questionnaires for quality of life and physical functioning. Progression-free survival is tracked for at least one year after randomization. Researchers closely monitor treatment toxicity, hospitalizations, dose modifications, and survival. The total planned enrollment is 587 patients, with follow-up for safety and effectiveness throughout the treatment period.

Researchers are evaluating whether skipping re-excision surgery after complete removal of primary cutaneous melanoma affects patient outcomes. This phase III randomized controlled trial includes 1,749 patients with pT1b-pT4b melanoma who show no signs of metastases. The study aims to compare relapse-free survival between patients who receive standard re-excision according to guidelines and those who do not undergo re-excision, while also assessing overall survival, recurrence rates, surgical complications, quality of life, and health economic impacts. Participants will be randomly assigned to either the re-excision group, where additional surgery is performed within 12 weeks of initial excision following standardized procedures, or the no re-excision group, where no further surgery is done on the primary tumor site. Sentinel lymph node biopsy and adjuvant systemic therapies may be given as recommended in both groups. Surgical details, including margin measurements and pathological assessments, are carefully documented for those undergoing re-excision. During the study, patients will be followed for up to 5 years with regular monitoring for melanoma recurrence and survival. Researchers will collect data on local, in-transit, nodal, and distant recurrences, surgical complications graded by a standard system, patient-reported quality of life and scar outcomes, and healthcare costs. Outcomes will be analyzed using statistical methods to compare the groups, with an interim analysis planned to evaluate study progress and safety.

Researchers are evaluating the best rehabilitation approach for patients with displaced intra-articular calcaneal fractures (DIACFs), a rare type of heel bone fracture often requiring surgery. This study compares two rehabilitation protocols: Permissive Weight Bearing (PWB) and Restricted Weight Bearing (RWB), to see which leads to better functional outcomes, quality of life, fewer complications, and cost-effectiveness. The trial focuses on adults aged 18 to 67 who have had surgical treatment for specific types of DIACFs. Participants are randomly assigned to either the PWB or RWB group. The PWB group begins weight bearing about two weeks after surgery once the wound has healed, increasing weight bearing as tolerated based on pain and comfort, guided by milestones like walking with crutches or canes. The RWB group follows a stricter protocol with 8 to 12 weeks of minimal weight bearing, gradually increasing weight bearing by 25% weekly after 8 weeks following current guidelines. Therapists and physicians record the patients' progress and advice throughout treatment. During the study, patients will be monitored at 2, 6, 12 weeks, and 6 months after surgery using functional outcome questionnaires (AOFAS score) and other assessments. Researchers will measure recovery progress, quality of life, differences seen in X-rays, complications, and treatment costs. Follow-up visits align with standard trauma care, and radiation exposure matches usual care, making the study burden minimal and safe for participants.

Researchers are studying metastatic castration-resistant prostate cancer to see if taking hormone drugs abiraterone or enzalutamide in a pause-and-restart way works better than taking them continuously every day. These drugs are commonly used to treat advanced prostate cancer, but over time, their effectiveness often declines as resistant cancer cells grow. The study is based on the idea that temporarily stopping treatment might keep some treatment-sensitive cancer cells alive, which could slow the growth of resistant cells and prolong the time the cancer stays under control. Participants will be randomly assigned to two groups. One group will take abiraterone or enzalutamide daily without stopping until the cancer no longer responds. The other group will start daily treatment until their PSA (a blood marker) drops by more than 50%, then pause treatment while monthly PSA tests are done. Treatment will restart if PSA rises back to the initial level and will continue until PSA drops again by over 50%. This pause-and-restart cycle repeats until treatment failure, defined by cancer progression or death. During the study, patients will have regular PSA blood tests every 4 weeks and imaging scans every 12 weeks to monitor cancer progression. Researchers will track time until treatment failure, which includes death or signs that the cancer is no longer responding. Safety and side effects will be monitored throughout. The total study duration includes ongoing assessments for up to three years after randomization, helping to understand how these treatment approaches affect disease control and patient well-being.

Obesity is a complex condition influenced by genetics, environment, nutrition, psychology, and physical activity. It increases the risk of metabolic disorders like dyslipidemia, hypertension, and high blood sugar, as well as certain cancers. Bariatric surgery is the most effective long-term treatment for severe obesity, leading to weight loss and improved quality of life, but results can vary between individuals. This study aims to identify factors before surgery that predict improvements in weight loss and metabolic health, such as inflammation, insulin sensitivity, glucose regulation, psychological traits, eating behaviors, and fitness levels. Participants scheduled for primary bariatric surgery, specifically Roux-en-Y gastric bypass or sleeve gastrectomy, will be studied. A subgroup of patients undergoing Roux-en-Y gastric bypass who are insulin resistant and postmenopausal women will receive additional evaluation. The study will track these participants from before surgery and follow them for up to five years after the procedure, focusing on metabolic health and weight loss outcomes. During the study, researchers will assess various predictors of metabolic health improvements, including insulin sensitivity, glucose control, insulin levels, lipid profiles, and inflammation. These measures will be evaluated from baseline up to five years post-surgery. Participants will undergo regular assessments to monitor these outcomes, and the study will collect data on their weight loss and metabolic changes over time to better understand who benefits most from bariatric surgery.