Apeldoorn

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.

Researchers are evaluating treatments for people with newly diagnosed multiple myeloma who are not candidates for or do not plan to have autologous stem cell transplant as initial therapy. The study compares the effectiveness of two new combination treatments: teclistamab with daratumumab and lenalidomide (Tec-DR), and talquetamab with daratumumab and lenalidomide (Tal-DR), against the standard treatment of daratumumab, lenalidomide, and dexamethasone (DRd). This is a Phase 3 randomized study designed to assess which treatment better controls the disease. Teclistamab, talquetamab, and daratumumab are given as subcutaneous injections, while lenalidomide is taken orally. Dexamethasone can be given either orally or by intravenous injection. Participants receive one of the three treatment combinations as assigned by the study. The treatments are administered regularly over the study period, with close monitoring and follow-up to evaluate outcomes. The study includes up to 9 years of follow-up to track disease progression and survival. Participants will undergo regular assessments including monitoring for disease progression and treatment response. Key measures include progression-free survival from the time of randomization and the presence of minimal residual disease-negative complete response at 12 months. Safety and tolerability are also tracked throughout the study. Total participation time includes treatment and extended observation to assess long-term outcomes and side effects.

Carpal Tunnel Syndrome is a common condition causing numbness, pain, and weakness in the hand. Surgical decompression is the most effective treatment for this condition. After surgery, about 1.8% of patients develop wound infections, and this study evaluates whether the type of sutures used—absorbable versus non-absorbable—affects the risk of infection. This is a randomized controlled trial investigating infection rates related to suture type in carpal tunnel release surgery. Participants will undergo carpal tunnel release surgery, which involves cutting the flexor retinaculum to relieve pressure on the median nerve. The study compares the use of absorbable sutures, which dissolve over time, with non-absorbable sutures, which are later removed. Both suture types are commonly used in current clinical practice, but the study aims to determine if one leads to fewer wound infections. The primary outcome measured is the ASEPSIS wound score assessed 10 to 14 days after surgery. During the study, independent investigators will evaluate wound healing and infection signs using the ASEPSIS score. Researchers will also track antibiotic use, hand therapy, and extra outpatient visits. Patients are asked to record their pain scores for the first three weeks after surgery to monitor recovery. This study helps understand the impact of suture choice on wound healing and infection after carpal tunnel release surgery.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

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 accuracy of functional cine magnetic resonance imaging (MRI) in detecting and mapping internal abdominal adhesions. Adhesions commonly form after abdominal surgery as part of healing but can cause complications like chronic pain, bowel obstruction, and difficulties during repeat surgeries. Currently, no validated imaging method exists to reliably map these adhesions before surgery. The study uses a CineMRI scan of the abdomen performed at 1.5 Tesla to identify adhesions. The main goal is to measure how sensitive and specific this imaging technique is at detecting adhesions between the abdominal wall and other tissues. The trial is designed as a prospective multicenter observational study involving patients undergoing reoperation, focusing on both adhesion presence and location. Participants will receive the CineMRI scan, and researchers will compare imaging results to surgical findings to evaluate accuracy. The primary measurement is sensitivity and specificity after 2 weeks. Approximately 100 patients are expected to enroll, with the study completing by December 2019. The trial monitors how well the MRI detects adhesions to the abdominal wall and between organs without additional interventions or treatments.

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.

Researchers are investigating the treatment of multiple myeloma using a combination of medicines called daratumumab-lenalidomide-dexamethasone (Dara-Rd). This standard treatment in the Netherlands often suppresses the disease for a long time and continues until it stops being effective. The study aims to find out if stopping treatment temporarily, compared to continuing it without breaks, can improve quality of life by reducing side effects and allowing recovery from toxicity, without reducing survival time. The study involves patients who have completed 12 cycles of Dara-Rd treatment and have responded with at least a partial response without biochemical progression. These patients will be randomly assigned to either continue Dara-Rd treatment continuously or take a treatment-free interval. The medications involved include daratumumab injections, lenalidomide capsules, and dexamethasone. Reduced dosing of lenalidomide is allowed but not below 5 mg, and prior dexamethasone dose changes are permitted. The trial is a nationwide, open-label, randomized Phase III study. Participants will be followed for up to approximately 57 months to compare event-free survival and up to 69 months to compare progression-free survival after randomization. Researchers will monitor disease status, side effects, and overall health during this time. Patients must provide informed consent and will undergo regular assessments to evaluate the impact of continuous versus interrupted therapy on their disease and quality of life.

Acute coronary syndrome (ACS) is a leading cause of death worldwide. Researchers aim to improve cardiovascular care by creating a detailed, ongoing registry of patients with ACS to study the long-term effects of diagnostics, treatments, and devices used in everyday clinical practice. This approach addresses limitations of randomized controlled trials (RCTs) by capturing real-world patient data and outcomes for better evaluation and quality improvement, especially in the Dutch healthcare system. The study collects clinical and possibly genetic information from patients presenting with ACS in a prospective manner. It uses electronic patient records to gather data uniformly, allowing researchers to assess medication, devices, diagnostic tools, and follow-up care. The registry supports evaluating risk scores, comparing treatments, and enhancing adherence to guidelines to improve patient outcomes and secondary prevention. Participants are followed over time with regular data collection on mortality, recurrent ischemic events, hospital admissions, and quality of life. The study evaluates health-care pathways, treatment effectiveness, and safety in routine practice compared to clinical trials. The registry's ongoing nature helps monitor long-term impacts and supports personalized medicine efforts, focusing on improving care coordination between cardiologists and general practitioners.

This research aims to study healthcare use among patients with liver cirrhosis, including both compensated and decompensated cases. The study looks at the course of the disease and factors like psychosocial elements that may influence how often patients use healthcare services. It is a multicenter, retrospective cohort study, meaning it reviews past patient data from multiple centers to understand these patterns. The study involves no active treatment or intervention. It analyzes medical records to count how many times patients had outpatient visits, radiographic imaging, esophagogastroscopies, and elastographies related to liver cirrhosis. These counts cover the two years before any liver cirrhosis complications, death, or loss to follow-up. Participants' past healthcare use is examined through their medical records. Researchers measure the number of liver cirrhosis-related outpatient contacts and specific procedures over time. The study includes adult patients aged 18 years and older diagnosed with liver cirrhosis. There is no maximum age limit, and data collection is retrospective, so participant involvement is through their existing records rather than active visits or treatments.