Almelo

Researchers are studying a new type of scan called FAPI-PETCT to see how well it detects metastases in patients with advanced gastric cancer. The study aims to find out if this scan can better identify cancer spread, leading to changes in treatment plans such as avoiding unnecessary surgeries or shifting to comfort-focused care. It also evaluates whether the scan causes less burden for patients compared to current methods. Participants will receive the standard care for gastric cancer and undergo one additional FAPI-PETCT scan, where a small amount of 18F-FAPI-74 is given intravenously about 60 minutes before a PETCT scan lasting around 20 minutes. The results from this scan will help doctors decide on further tests or surgery needed. The study monitors changes in diagnosis and treatment decisions based on the scan. During the study, participants will complete questionnaires taking about 4 hours total and spend approximately 2 hours for the extra scan. Researchers will measure outcomes such as changes in treatment intent, diagnostic work-up, scan accuracy, incidental findings, patient burden, quality of life, and safety over about one year. Follow-up includes quality of life assessments and cost evaluations at multiple time points after staging.

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.

This research aims to compare the effects of oral anticoagulation versus no anticoagulation in patients aged 55 and older who have had recent episodes of transient atrial fibrillation triggered by stress and have additional factors that increase their risk of stroke. The study is a multinational, investigator-initiated, prospective, randomized, open-label trial evaluating the impact of non-vitamin K oral anticoagulants NOACs on preventing stroke and other serious cardiovascular events. Participants will be randomly assigned to either receive one of several NOACs, such as edoxaban, apixaban, dabigatran, or rivaroxaban, prescribed by their physician for the duration of the follow-up, or to a control group that will not receive anticoagulants unless medically indicated during the study. The choice of specific NOAC and dose adjustments are determined by the prescribing doctor. The study excludes patients with certain conditions like chronic atrial fibrillation, severe kidney or liver disease, recent cardiac surgery, or bleeding risks. During the study, participants will be monitored for up to 24 months to assess the occurrence of non-hemorrhagic stroke, systemic embolism, vascular mortality, myocardial infarction, peripheral arterial thrombosis, amputation, and venous thromboembolism. Regular follow-up will include evaluation of these outcomes to measure the effectiveness and safety of anticoagulation compared to no anticoagulation. Participants will provide informed consent and remain under medical supervision throughout the trial.

Researchers are studying patients with non-metastatic stage II colon cancer who are part of the Dutch ColoRectal Cancer cohort PLCRC and who consented to additional blood samples. The study aims to evaluate how many patients with detectable circulating tumor DNA ctDNA after surgery begin adjuvant chemotherapy. This observational and interventional trial includes patients who do not have a standard indication for chemotherapy and involves a randomized design to compare ctDNA-guided treatment with standard care. Patients are randomly assigned to one of two groups the ctDNA-based treatment group or the standard care group. In the ctDNA group, blood samples taken after surgery are analyzed for ctDNA. Those with detectable ctDNA are offered 3 months of adjuvant chemotherapy using CAPOX a combination of fluoropyrimidine and oxaliplatin. Patients without detectable ctDNA receive routine follow-up care. The standard care group receives routine follow-up without knowledge of their ctDNA results. Participants will have blood collected before surgery, after surgery, and during follow-up. Researchers will monitor who starts chemotherapy within 8 to 12 weeks after surgery and will track recurrence rates, disease-free survival, overall survival, time to recurrence, quality of life, and cost-effectiveness over several years. Follow-up assessments occur up to 10 years, allowing detailed long-term evaluation of treatment impact and patient outcomes.

Researchers are studying whether adjuvant chemotherapy can prevent disease recurrence in adults with high-risk rectal cancer who have detectable circulating tumor DNA ctDNA after surgery. The study aims to determine if this chemotherapy improves disease-free survival compared to standard care. Rectal cancer remains a significant cause of mortality, and while current treatments reduce local recurrence, distant recurrence rates stay high. Identifying patients with residual disease through ctDNA may help target those who might benefit from additional chemotherapy. Participants with detectable ctDNA after surgery will be randomly assigned to receive either standard care or adjuvant chemotherapy consisting of 6 cycles of FOLFOX 5FUfolinic acid and oxaliplatin every 2 weeks or 4 cycles of CAPOX capecitabine and oxaliplatin within 8 to 12 weeks after surgery. The chemotherapy treatment lasts about 3 months. The study is conducted within a prospective colorectal cancer cohort using a randomized controlled design. During the study, participants will have blood samples taken and visits with their physicians before each chemotherapy cycle if assigned to treatment. Researchers will monitor disease-free survival, overall survival, and quality of life using questionnaires over several years. They will also assess the clearance of ctDNA after chemotherapy and study its presence at recurrence. The total follow-up includes up to 2 years for disease recurrence and up to 5 years for survival outcomes.

Researchers are collecting real world data from medical devices and clinical outcomes in patients with diabetes mellitus to better understand the disease and improve care. This observational study focuses on adults with type 1 or type 2 diabetes who attend the outpatient internal medicine clinic at Ziekenhuisgroep Twente. The goal is to build a detailed registry capturing important health information over time. Participants are followed through routine clinical visits where medical device data and health outcomes are gathered and recorded in the registry. There are no experimental treatments involved, and the study relies on information obtained during standard care visits. The study started in September 2020 and plans to collect data for up to 30 years. During their participation, patients will have their device data and clinical results regularly collected and monitored. Researchers will evaluate this information to understand patient health trends and outcomes. Participation involves giving informed consent and allowing access to medical records and device data. The study continues until December 2060, with ongoing data collection and review.

Researchers are evaluating the distribution of lymph node metastases in patients with esophageal or gastro-esophageal junction carcinoma who undergo transthoracic esophagectomy with at least a two-field lymphadenectomy. This multinational observational study aims to better understand how lymph node spread varies by tumor location, histology, invasion depth, and use of neoadjuvant therapy. By studying these patterns in a large patient group, the research seeks to inform more tailored treatments, such as optimal radiation fields and surgical approaches. This study includes all patients with resectable esophageal carcinoma undergoing transthoracic esophagectomy with two- or three-field lymphadenectomy in participating centers across 18 countries. All lymph node stations removed during surgery are examined separately. The study will analyze patterns of metastases in relation to tumor characteristics and treatment history, including the use of neoadjuvant chemoradiotherapy. No additional procedures are performed beyond standard care. Participants will be followed for five years after surgery according to national guidelines, with regular follow-up visits scheduled every three months in the first year, every six months during years two to four, and annually in the fifth year. Researchers will collect data on lymph node involvement, recurrence patterns, survival outcomes, and diagnostic accuracy. This information will help identify subgroups of patients with different metastasis patterns and assess long-term disease-free and overall survival.

Researchers are evaluating the feasibility and safety of a ventilation strategy called permissive lung-protective ventilation in adult critically ill patients who require invasive mechanical ventilation due to acute hypoxemic respiratory failure. This pilot trial aims to inform the design of a future larger randomized clinical trial by comparing permissive lung-protective ventilation with conventional lung-protective ventilation. The study focuses on how lowering the respiratory rate may reduce ventilation intensity while managing carbon dioxide levels safely. Participants are randomly assigned to one of two groups one group receives permissive lung-protective ventilation where the respiratory rate is gradually reduced based on blood gas analysis and continuous monitoring, allowing mild increases in carbon dioxide levels within safe limits. The other group receives conventional lung-protective ventilation with standard respiratory rates targeting normal carbon dioxide and pH levels. Blood gas analyses are performed frequently to monitor patient status until ventilator weaning or extubation. Throughout the study, participants undergo regular assessments including arterial blood gas tests, continuous end-tidal CO2 monitoring, and data collection on ventilation parameters and outcomes. Researchers measure the feasibility of reducing respiratory rate, adherence to the protocol, safety indicators such as hypercapnia and hypoxemia, and ventilator-associated complications. Data collection continues up to 90 days for follow-up, with the primary evaluation lasting from ventilation start until first extubation, up to 28 days.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.

This research investigates patients with hip fractures who are taking direct oral anticoagulants DOACs, a type of blood thinner. The study aims to determine whether performing surgery within 24 hours of hospital admission is as safe as delaying surgery beyond 24 hours. This is important because surgery delays may reduce bleeding risks but can also increase complications, longer hospital stays, and mortality. The study is designed as a natural experiment comparing these two timing strategies across multiple hospitals in the Netherlands. The study compares outcomes between patients who receive hip fracture surgery within 24 hours of emergency department arrival early surgery and those who have surgery after 24 hours delayed surgery. No additional procedures are performed beyond routine care, and the timing of surgery is based on hospital protocols. Data on blood transfusions, hemoglobin levels, complications, hospital stay, and functional recovery at three months are collected from electronic health records. Participants are monitored through information routinely recorded during hospital care, including blood transfusion needs after surgery and various postoperative complications. Data quality is ensured by standardized documentation and regular checks. The main measurement is whether patients require blood transfusions after surgery, observed until hospital discharge or up to 30 days. The total participation involves hospital stay from emergency presentation until discharge, with outcomes also assessed up to three months after surgery.