Enschede

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are investigating a new treatment called BAY 3389934 for people who have sepsis-induced coagulopathy, a condition where an infection causes excessive blood clotting that can damage blood vessels and organs. This Phase 1 study aims to understand how safe BAY 3389934 is, determine the right dose, and observe its effects on patients being treated for sepsis-induced coagulopathy in an intensive care unit (ICU). Participants will receive BAY 3389934 as an intravenous infusion. They will be divided into two groups: the first group receives the lowest starting dose, and based on safety and tolerance, the dose may be adjusted. If no serious side effects occur, the second group will receive a higher dose. Each participant will be involved in the study for about 28 days. During the study, doctors will monitor participants closely by taking blood and urine samples, performing physical exams, checking vital signs like body temperature and heart rate, and examining heart health with electrocardiograms (ECG). Researchers will track any medical problems that arise during and after treatment, called adverse events, to evaluate safety. The main outcomes measured include the number and severity of treatment-emergent adverse events from the first dose up to 97 hours after stopping the treatment.

Researchers are investigating a treatment approach for older adults with acute myeloid leukemia (AML) who are not fit for intensive chemotherapy. The study focuses on combining venetoclax with hypomethylating agents (HMAs) like azacitidine, which have milder side effects suitable for older or medically fragile patients. The addition of cobicistat, a CYP3A4 inhibitor, aims to boost venetoclax exposure, potentially reducing the venetoclax dose and lowering treatment costs while maintaining effectiveness. This is a Phase II trial targeting newly diagnosed AML patients who are unable or unwilling to undergo intensive chemotherapy. Participants will receive azacitidine and venetoclax starting at Cycle 1 and continuing until disease relapse. Cobicistat will be introduced from Cycle 2 during the run-in phase and from Cycle 1 in the extension phase, continuing until relapse. This design evaluates the pharmacokinetic equivalence of cobicistat-boosted venetoclax compared to unboosted venetoclax and monitors overall survival up to 48 months. The trial is single-arm, assessing the combined treatment's safety and effectiveness in the specified patient group. During the study, patients will undergo regular monitoring including pharmacokinetic assessments in early cycles and survival follow-up for up to four years. Researchers will evaluate venetoclax blood levels, overall survival, and treatment safety. Participants must provide informed consent and agree to contraception measures if applicable. The trial excludes patients with certain medical conditions or prior treatments that could interfere with the study. This careful follow-up ensures comprehensive evaluation of treatment impact and patient health throughout the trial.

Anastomotic leakage (AL) is a serious complication after colon surgery, linked to higher mortality, lower quality of life, and increased healthcare costs. This research evaluates whether preventive endovascular stenting of a narrowed superior mesenteric artery (SMA) can reduce the risk of AL in patients aged 40 and older undergoing elective colon resection with primary anastomosis. The study is a nationwide multicenter randomized controlled trial involving patients with over 50% SMA stenosis, aiming to improve surgical outcomes and survival. Participants are randomly assigned to either receive preventive percutaneous transluminal angioplasty with a covered stent placed in the SMA before colon surgery or to undergo colon surgery without this stenting. Both groups receive mono antiplatelet therapy with daily Ascal (carbasalate calcium) to reduce atherosclerotic risks and maintain stent patency. The stenting procedure is ideally done within two weeks before surgery. Colon surgery follows standard protocols, and some centers use intraoperative fluorescence angiography to assess blood flow. During the 12-month follow-up, researchers monitor the occurrence of clinically relevant AL within 90 days after surgery as the primary outcome. They also assess AL severity, delayed leakage, surgical complications, hospital stays, readmissions, mortality, quality of life, and health economic impacts. Patient-reported outcomes are collected at multiple points post-surgery through questionnaires. Safety and stent performance are closely observed, with comprehensive data collected to evaluate the intervention's effectiveness and cost implications.

This trial studies men with low-volume, hormone-sensitive metastatic prostate cancer to evaluate if a shorter treatment duration with androgen receptor pathway inhibitors (ARPIs) like Apalutamide or Enzalutamide is as effective as continuous therapy. The purpose is to see if stopping ARPI treatment after 12 months, with the option to restart if the cancer progresses, can reduce side effects and costs without worsening outcomes. This is a Phase 3 randomized nationwide study focusing on patients with low-volume metastatic disease confirmed by imaging and clinical assessment. Participants will receive androgen deprivation therapy (ADT) combined with either continuous ARPI treatment or ARPI treatment stopped at 12 months. Those who stop ARPI after 12 months may restart treatment if their PSA levels rise, confirmed by a second test at least 4 weeks later. The study compares these two approaches to understand if shorter ARPI use is non-inferior to continuous use, aiming to reduce treatment toxicity while maintaining disease control. Participants will be followed for up to 6 years, with clinical progression-free survival as the main outcome. Researchers will monitor time from study inclusion to disease progression or treatment end. Patients will undergo regular assessments including PSA testing and clinical evaluations to track disease status. Safety and treatment effects will be closely observed throughout the study period, which includes up to 5 years of active follow-up after randomization.

Researchers are investigating how using a supportive soft-robotic glove affects the real-life use of arm and hand function in daily activities. This study involves 3 to 5 patients who have hand function limitations caused by trauma-related injuries or neurological conditions. It is designed as a single-case experimental study and builds upon previous research with earlier versions of the Carbonhand robotic glove to better understand its therapeutic effects. Participants will use the Carbonhand soft-robotic glove at home for six weeks during daily activities that matter most to them. The glove supports the grip of their most affected hand, and participants can choose which activities to perform with it, aiming to use it at least 180 minutes per week for common tasks such as household chores, dressing, eating, cooking, or leisure. The study includes phases before, during, and after the glove use period. Over 12 to 14 weeks, participants will complete short tests about 15 times, which include wearing activity meters on both wrists during waking hours to track arm movement and performing hand squeeze tests supervised via video calls. They will also answer questions about their perceived hand function and well-being. Researchers will closely monitor arm activity, hand function, and safety throughout the study to evaluate the glove's impact and participant experience.

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.

This research investigates the best approach for treating low-risk patients with isolated subsegmental pulmonary embolism (SSPE), a condition where small blood clots block tiny arteries in the lungs. The study aims to clarify whether SSPE truly requires anticoagulant treatment or if careful monitoring without medication is a safe option. Currently, many patients receive anticoagulants, which can increase bleeding risk, but some evidence suggests that avoiding these drugs might be safe in selected patients without other complications. Participants are randomly assigned to receive either the anticoagulant drug rivaroxaban or a placebo, allowing comparison between clinical surveillance without anticoagulation and standard anticoagulation treatment. This phase 4, multicenter trial evaluates outcomes over a 90-day period following randomization. During the study, researchers monitor participants for recurrent venous thromboembolism and assess safety outcomes related to bleeding. Participants provide informed consent and are followed closely to observe any clots returning or adverse events. The total follow-up is at least 90 days to determine the efficacy and safety of withholding anticoagulation in this specific patient group.

Researchers are investigating treatments for patients with Median Arcuate Ligament Syndrome (MALS), a condition where the median arcuate ligament compresses the coeliac artery, leading to chronic disabling abdominal pain after eating, weight loss, and reduced quality of life. Many patients endure a long journey before diagnosis, and while surgery has shown symptom relief and quality of life improvement, there is no international consensus on diagnosis or treatment. This trial aims to provide clear evidence by comparing surgical coeliac artery release with a sham operation in a randomized, blinded study. The study compares two procedures: an endoscopic coeliac artery release (eCAR) performed through a retroperitoneal approach using four trocars by experienced surgeons, and a sham operation involving four incisions without actual artery release but under the same anesthesia duration. This design maintains blinding of patients and observers. After six months, patients who received the sham operation and still have symptoms may choose to undergo eCAR. The trial includes a two-year follow-up to assess lasting effects and rule out placebo influences. Participants will be assessed using symptom relief scales such as VAS and PGI-I at six months post-randomization. The study involves multidisciplinary diagnosis confirmation, imaging to measure artery stenosis, and regular monitoring of symptoms and quality of life. Safety is closely watched, and those in the sham group have access to surgery if needed after unblinding. The total study duration includes initial treatment and extended follow-up to measure outcomes and ensure participant safety.