Enschede

Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.

Researchers are investigating a new drug called BAY 3389934 to find a better way to treat people with sepsis-induced coagulopathy, a serious condition where an active immune response causes uncontrolled blood clotting, damaging blood vessels and organs. This early-phase study aims to learn about the safety, appropriate dose, and effects of BAY 3389934 in patients receiving treatment for this condition in intensive care units. The research is focused on monitoring medical problems, called adverse events, that occur during and after treatment. Participants will receive BAY 3389934 as a continuous intravenous infusion for up to 96 hours. They will be divided into two groups the first group will receive a low starting dose, and their response will be closely monitored to adjust the dose if needed. If there are no serious side effects, the second group will receive a higher dose. This dose escalation approach helps determine the best dose for future studies. During the approximately 28-day study, participants will have blood and urine samples taken, physical exams, vital signs checked, and heart health monitored with electrocardiograms. Researchers will track the number and severity of any treatment-emergent adverse events within about four days after starting the infusion. They will also measure blood clotting times over the first six days to assess effects on coagulation. The study is designed to carefully observe safety and drug effects while patients receive intensive care.

This trial investigates adults aged 45 to 80 with elevated Lipoproteina Lpa levels, who either have existing cardiovascular disease or are at risk for a first cardiovascular event. The study aims to evaluate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the coronary arteries using Coronary Computed Tomography Angiography CCTA. Lipoproteina is a protein carrying cholesterol and is linked to higher heart disease risk. Participants are randomly assigned to receive either lepodisiran or a placebo through subcutaneous injections. The study lasts about 120 weeks, with primary evaluation of changes in noncalcified plaque volume at baseline and at week 104. Secondary measures include changes in fat attenuation index scores, Lpa levels over time, participant feedback on drug administration, and pharmacokinetic analysis. Throughout the study, participants will undergo imaging assessments, blood tests to monitor Lpa levels, and questionnaires regarding treatment experience. The main outcome is the percent change in noncalcified plaque volume in heart vessels. The study includes safety monitoring and continues follow-up to assess effects comprehensively over the study period.

Researchers are studying a treatment approach for older adults with acute myeloid leukemia AML who are not suitable for intensive chemotherapy. The study focuses on combining the drug venetoclax with azacitidine, and investigates whether adding cobicistat, a drug that increases venetoclax exposure, can allow for lower venetoclax doses to reduce treatment costs. This is a Phase II trial led by Stichting Hemato-Oncologie voor Volwassenen Nederland, addressing the challenge of treating older, unfit AML patients with fewer side effects and financial burden. Participants receive azacitidine and venetoclax from the first treatment cycle until relapse. Cobicistat is introduced during the run-in phase starting from cycle 2 and during the extension phase starting from cycle 1, aiming to boost venetoclax levels. The study includes a run-in phase with 20 patients and an extension phase, both following this treatment scheme. The trial is single-arm and non-randomized, designed to evaluate pharmacokinetic equivalence and overall survival among other outcomes. Throughout the study, participants will undergo regular monitoring to assess drug levels, treatment response, safety, and side effects for up to 48 months. Researchers will measure remission rates, survival rates, genetic changes, adverse events, and medication adherence. Data on cost savings and treatment effects will also be collected. Patients will be assessed for kidney and liver function, and their progress will be carefully followed to understand the impact of the cobicistat-boosted venetoclax treatment combined with azacitidine.

This research aims to evaluate whether preventive endovascular stenting of a significant narrowing over 50% in the superior mesenteric artery SMA can reduce the risk of anastomotic leakage AL after elective colon surgery. AL is a serious complication linked to higher mortality, lower quality of life, and increased healthcare costs. A prior study showed that having more than 50% SMA stenosis raises the risk of AL sixfold, and this trial investigates if stenting this artery before surgery can help prevent AL. Participants are randomly assigned to one of two groups the intervention group will receive preventive angioplasty and placement of a covered stent in the SMA before their colon surgery, while the control group will proceed with colon surgery without stenting. Both groups receive daily mono antiplatelet therapy with carbasalate calcium, lifelong for the intervention group and at least 12 months for the control group. The stenting procedure is minimally invasive and performed preferably within two weeks before surgery at specialized centers. Colon surgery is done according to standard local guidelines. Some centers will use intraoperative fluorescence angiography to assess blood flow during surgery. During the 12 months of follow-up after surgery, participants will be monitored for anastomotic leakage within the first 90 days, as well as delayed leakage and surgical complications up to one year. Researchers will collect data on hospital stays, reinterventions, mortality, quality of life, healthcare costs, and stent function. Patient-reported outcomes will be gathered through questionnaires at multiple time points. The study also includes imaging assessments and cost-effectiveness analyses to understand the broader impact of preventive stenting.

Researchers are evaluating a shorter treatment duration with androgen receptor pathway inhibitors ARPIs, specifically Apalutamide or Enzalutamide, in patients with low-volume hormone-sensitive metastatic prostate cancer. This phase 3 clinical trial aims to determine if stopping ARPI therapy after 12 months, with the option to restart if the cancer progresses, is not worse than continuing ARPI treatment. The goal is to reduce side effects and costs while maintaining effective disease control. Participants will be randomly assigned after completing 12 months of ARPI treatment to one of two groups one group will continue androgen deprivation therapy ADT combined with ARPI, while the other will stop ARPI after 12 months but may restart it if a confirmed rise in prostate-specific antigen PSA occurs. The PSA confirmation sample must be taken at least four weeks after the initial rise. Treatment will be monitored closely according to these protocols. During the study, participants will be followed for up to 6 years, including 5 years after randomization to track clinical progression-free survival. Researchers will regularly assess disease status, treatment effects, and possible side effects. The study includes regular visits and monitoring to evaluate how long patients remain free from disease progression while comparing the two treatment approaches.

Researchers are studying how using a supportive soft-robotic glove affects real arm and hand use during daily life for people with hand function limitations caused by trauma-related injuries or neurological conditions. This study follows up on earlier research with previous versions of the robotic glove Carbonhand to better understand its therapeutic effects. The study involves 3 to 5 participants and uses a single-case experimental design to observe changes over time. Participants will use the Carbonhand soft-robotic glove at home for six weeks during daily activities that are important to them, supporting the grip of their most affected hand. They can choose which activities and when to use the glove but are encouraged to use it at least 180 minutes per week. The study includes three phases a baseline phase without the glove, the intervention phase using the glove, and a retention phase without the glove again. Throughout the 12 to 14 weeks of the study, participants will complete about 15 home assessments spread across the three phases. These assessments include wearing activity meters on both wrists during waking hours, performing hand grip strength tests via video calls, and answering questions on hand function and well-being. Additional evaluations involve questionnaires, hand function tests, pain ratings, and interviews. The glove also collects usage data and participants keep a diary during the intervention phase. This thorough monitoring helps researchers measure actual arm activity and other outcomes related to hand use and quality of life.

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 investigating the best approach to treat low-risk patients with isolated subsegmental pulmonary embolism SSPE, a type of blood clot in small lung arteries. The study aims to determine whether monitoring patients without anticoagulation is as safe and effective as giving anticoagulant medication. This is important because many patients currently receive anticoagulants that carry a risk of bleeding, but it is unclear if all patients with isolated SSPE need this treatment. Patients in the trial are randomly assigned to one of two groups. One group receives the anticoagulant drug rivaroxaban, starting with 15 mg twice daily for 21 days, then 20 mg once daily for a total of 90 days. The other group receives a placebo matching the same schedule. The trial compares clinical surveillance without anticoagulation to anticoagulation treatment to assess safety and effectiveness. Participants will be followed for 90 days after randomization to monitor for recurrent venous thromboembolism, significant bleeding events, and overall survival. Researchers will track these outcomes through clinical assessments and safety monitoring. This study is designed to evaluate if careful monitoring alone is a safe alternative to anticoagulation in selected patients with isolated SSPE, potentially reducing bleeding risks from treatment.

Researchers are evaluating the effectiveness of endoscopic Coeliac Artery Release eCAR compared to a sham operation in patients suspected of Median Arcuate Ligament Syndrome MALS. MALS involves significant external compression of the coeliac artery causing chronic disabling abdominal pain, weight loss, and related symptoms. The study aims to resolve ongoing debates about this condition by providing evidence on whether surgical release improves symptoms and quality of life. Participants are randomly assigned to either the eCAR procedure or a sham operation, both involving similar incisions to maintain blinding. The eCAR involves cleaving the median arcuate ligament via an endoscopic retroperitoneal approach using a specific four-trocar technique. The sham group undergoes incisions and anesthesia for a similar duration without ligament release. Procedures are performed by experienced surgeons, and patients and observers remain blinded to treatment allocation. During the study, participants are followed up for two years with assessments of abdominal pain, symptom relief using VAS and PGI-I scales, quality of life, productivity loss, healthcare use, and anatomical success measured by imaging. Safety is monitored through complication classification and additional treatments recorded. The primary outcome is symptom reduction measured six months after randomization. This comprehensive monitoring helps determine the value of eCAR for managing MALS and its impact on patient wellbeing and healthcare costs.