Almelo

Researchers are evaluating a new scan called FAPI-PET/CT to detect metastases in patients with advanced gastric cancer. The study aims to find out how well this scan identifies metastases and whether it reduces the burden on patients compared to current methods. Key questions include how often the scan changes treatment plans, such as avoiding unnecessary surgeries or switching to palliative care, and how it affects the diagnostic process with additional biopsies or surgery adjustments. Participants will receive the intravenous drug [18F]-FAPI-74 one hour before undergoing the FAPI-PET/CT scan. This scan is done after initial staging with gastroscopy and a contrast-enhanced CT but before a staging laparoscopy. Based on the scan results, the medical team will decide the next steps, which may include biopsy confirmation of suspect lesions or performing diagnostic laparoscopy if the scan is negative. During the study, participants will have one additional scan lasting about two hours (excluding travel) and complete several questionnaires totaling around four hours. Researchers will track changes in treatment intent for about one year and monitor changes in diagnostic work-up immediately after clinical staging involving FAPI-PET/CT and other diagnostic procedures. Safety and treatment decisions will be closely followed throughout the study period.

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.

Researchers are evaluating the use of non-vitamin K oral anticoagulants (NOACs) compared to no anticoagulation in people who have experienced transient atrial fibrillation episodes triggered by stress and have additional risk factors for stroke. This multinational, investigator-initiated Phase 4 trial aims to prevent stroke and other serious cardiovascular events in this group by assessing the effects of NOACs on two main outcomes: the occurrence of non-hemorrhagic stroke or systemic embolism, and a combination of vascular death and other major cardiovascular problems, over a follow-up period lasting until the last participant reaches 24 months of observation. Participants in the study are randomly assigned to either receive one of several NOAC medications—edoxaban, apixaban, dabigatran, or rivaroxaban—with dosing adjusted as needed and chosen by their prescribing doctor, or to receive no oral anticoagulation. The treatment continues throughout the follow-up period. The trial is open-label, meaning both researchers and participants know which treatment is given. The study specifically focuses on patients who had transient atrial fibrillation related to stress, such as after certain surgeries or acute medical illness. During the study, participants undergo regular monitoring to track the incidence of stroke, embolism, vascular death, heart attacks, blood clots, and other cardiovascular events. Researchers collect information over up to two years to evaluate these outcomes. Safety and adherence to treatment are also monitored. This thorough follow-up helps determine the impact of NOAC treatment compared to no anticoagulation in this particular patient population.

Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design). Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.

Researchers are collecting real world data from medical devices and clinical outcomes in patients with diabetes mellitus to build a registry. This registry aims to provide insights that can help improve personalized care for individuals living with type 1 or type 2 diabetes. The study includes patients who are receiving outpatient care at the ZGT Hospital. Participants include adults aged 18 years or older who visit the internal medicine outpatient clinic. There are no specific interventions or treatments assigned as part of this study; rather, it focuses on gathering data from existing medical devices and clinical records. The study does not specify an end age limit for participation. During the study, patients will provide written informed consent and their medical data will be collected and entered into the diabetes registry. The main outcome measure is the analysis of real world data from medical devices alongside clinical outcomes over a period of up to 30 years. This long-term data collection will support improved understanding and care for diabetes patients.

Researchers are studying the pattern of lymph node metastases in patients with esophageal carcinoma who have undergone transthoracic esophagectomy with at least a 2-field lymphadenectomy. This multinational observational cohort study aims to understand how lymph node involvement varies by tumor location, histology, invasion depth, and neoadjuvant therapy. The study will include patients with resectable esophageal or gastro-esophageal junction cancers and will help guide patient-specific treatment strategies such as radiation field design and lymphadenectomy extent. The study will enroll about 5000 patients over 2 years and follow them for 5 years. All lymph node stations removed during surgery will be separately examined pathologically using standard staining and additional tests if micro-metastases are suspected. Patients will receive standard care according to national guidelines, including neoadjuvant chemotherapy or chemoradiation when indicated. The study will analyze lymph node metastasis distribution and compare groups based on tumor characteristics and treatment. Participants will be followed up regularly for 5 years after surgery with visits every three months in the first year, every six months in years two to four, and annually in the fifth year. Researchers will collect data on lymph node metastases, survival, recurrence patterns, diagnostic accuracy of imaging tests, and treatment outcomes. Statistical analyses will identify metastasis patterns and assess prognostic factors to improve personalized treatment approaches for esophageal cancer patients.

Researchers are evaluating the feasibility and safety of permissive lung-protective ventilation in critically ill adults who require invasive mechanical ventilation due to acute hypoxemic respiratory failure. This pilot study aims to inform the design of a future larger randomized clinical trial. The study compares a lower respiratory rate ventilation strategy that allows mild hypercapnia with a conventional lung-protective ventilation approach maintaining normal blood gas levels. Both strategies are considered standard care in intensive care units, and the study focuses on patients expected to be ventilated for more than 24 hours. Participants are randomly assigned to one of two groups. The intervention group receives permissive lung-protective ventilation, where the respiratory rate is gradually reduced stepwise, guided by arterial blood gas analysis and continuous carbon dioxide monitoring, targeting a partial pressure of carbon dioxide up to 8.5 kPa and arterial pH above 7.20. The respiratory rate is decreased every 10 minutes until reaching a minimum of 4 breaths per minute, continuing until spontaneous breathing begins. The control group follows conventional lung-protective ventilation with respiratory rates adjusted to maintain normal carbon dioxide and pH levels. Blood gas analyses are performed hourly for six hours after randomization and then every eight hours during nursing shifts. During the study, patients are monitored from the start of mechanical ventilation until the first extubation for up to 28 days. Researchers collect demographic, ventilation, and outcome data without additional harm beyond standard care. Safety is assessed by monitoring for unacceptable hypercapnia, hypoxemia, and ventilator-associated complications. The primary outcome is the feasibility of the intervention, measured by the difference in respiratory rates between groups. Secondary measures include protocol compliance and data collection feasibility. The total participation duration depends on ventilation length and clinical progress.

Researchers are evaluating the use of mifepristone 50 mg taken once a week as a contraceptive for women aged 18 to 35. This phase III study aims to confirm that the chance of pregnancy while using this contraceptive is very low and to demonstrate that mifepristone is safe. Since mifepristone does not contain hormones like estrogens or progestogens, it is expected to have fewer side effects than common hormonal contraceptives and to be better tolerated by users. Participants will take one oral tablet of mifepristone 50 mg once a week for 12 months. This study is open-label and multi-center, focusing on safety, effectiveness, and user acceptability of this weekly pill. The research will assess outcomes such as the overall pregnancy rate measured by the Pearl Index over 12 months and method failure rates, along with safety evaluations at 3, 6, and 12 months. During the study, participants will attend scheduled visits and are asked to maintain a daily diary via smartphone or computer and complete five online questionnaires. Researchers will monitor contraceptive adherence, side effects, and health status through these diaries and visits. The study will also collect medical data if complications or pregnancy occur, aiming to provide a comprehensive understanding of the contraceptive's performance and user experience over one year.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

This research evaluates patients with hip fractures who are taking direct oral anticoagulants (DOACs), a type of blood thinner. Surgery for these patients is often delayed due to bleeding concerns, but waiting longer may increase risks like complications and longer hospital stays. The study aims to determine if operating within 24 hours of emergency department presentation is as safe as delaying surgery beyond 24 hours, focusing on the need for blood transfusions after surgery. The study compares outcomes between two groups: patients having hip fracture surgery within 24 hours (early surgery) and those having surgery after 24 hours (delayed surgery). It uses existing clinical data recorded routinely in electronic health records from multiple hospitals. No extra procedures are performed on participants. Data quality is ensured by standardized documentation practices and regular monitoring. The study aims to include 374 patients, split evenly between the two timing groups, based on hospital protocols. Participants' data, including surgical timing, blood transfusions, hemoglobin changes, complications, length of hospital stay, mortality, and functional recovery at three months, are collected and analyzed. The primary outcome is the number of participants needing a postoperative blood transfusion up to 30 days after surgery. Secondary outcomes include complications like infections or delirium and hospital length of stay. Data management follows privacy regulations and quality checks to ensure accurate and complete information throughout the study period.