Apeldoorn

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

This trial studies newly diagnosed multiple myeloma in participants who are not candidates for stem cell transplant. It compares the effects of two drug combinations 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. The goal is to assess how these combinations affect disease progression and treatment response. Participants are randomly assigned to one of three groups receiving either Tec-DR, Tal-DR, or DRd. Teclistamab and talquetamab are given as subcutaneous injections, daratumumab is given subcutaneously, lenalidomide is taken orally, and dexamethasone can be given orally or intravenously. Treatments are administered according to the study protocol over an extended period, with follow-up lasting up to nine years to monitor outcomes. During the study, participants undergo regular evaluations including disease progression monitoring, minimal residual disease status at 12 months, and assessments of response levels. Researchers also track survival, adverse events, laboratory and vital sign changes, quality of life, and drug concentrations. The study involves multiple visits for treatment and assessment to carefully evaluate the long-term impact of these drug combinations on patient health and disease control.

Carpal Tunnel Syndrome is a common condition that causes symptoms like tingling, pain, numbness, and weakness. Surgery called carpal tunnel release is the most effective treatment. This research compares two types of sutures used to close wounds after surgery absorbable and non-absorbable to see if one type affects the chance of wound infection. The study is a randomized controlled trial investigating how sutures influence infections after surgery. Participants will receive carpal tunnel release surgery where the flexor retinaculum is cut to relieve pressure. After surgery, wounds will be closed using either absorbable sutures Vicryl rapide or Safil quick or non-absorbable sutures Ethilon or Flexocrin. Both suture types are commonly used, but this study aims to find if one leads to fewer infections. The trial does not use masking, and participants are randomly assigned to one of the two suture groups. During the study, researchers will assess wound healing using the ASEPSIS wound score between 10 and 14 days after surgery. Patients will also record their pain using a Numeric Rating Scale for up to three weeks after surgery. Use of antibiotics, hand therapy, and any extra doctor visits will be recorded. The study is sponsored by Gelre Hospitals and includes adult participants aged 18 and older. Participation may last several weeks for follow-up and assessments.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

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.

Adhesions are common after abdominal surgery and can cause serious problems like chronic pain, bowel obstruction, or complications during repeat surgeries. Researchers are studying how well functional cine magnetic resonance imaging MRI can detect and map these adhesions in patients who have had previous abdominal surgery. This observational study aims to determine the accuracy of cineMRI in identifying adhesions to the abdominal wall and between organs. Participants will undergo a cineMRI scan of the abdomen using a 1.5 Tesla MRI machine. The study will observe patients who have a history of laparotomy with a median abdominal scar of at least 10 cm. There are no treatment interventions the focus is on imaging and diagnostic evaluation. During the study, participants will be assessed by comparing cineMRI results with surgical findings to measure the sensitivity and specificity of the MRI in detecting adhesions. The primary outcome is evaluated within two weeks. The study is conducted at multiple centers and is sponsored by Radboud University Medical Center.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

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.

Researchers are investigating whether taking breaks from the standard combination therapy of daratumumab, lenalidomide, and dexamethasone Dara-Rd for newly diagnosed multiple myeloma patients affects survival and quality of life. This study aims to compare continuous treatment versus planned treatment-free intervals to see if stopping therapy temporarily may reduce side effects, allow recovery from toxicity, and improve overall well-being while controlling the disease. Participants who have completed 12 cycles of Dara-Rd with at least a partial response and no signs of disease progression will be randomly assigned to one of two groups. One group will continue Dara-Rd therapy without interruption until disease progression, while the other group will stop treatment temporarily and restart it at biochemical progression, continuing until disease progression. The trial is open-label and will follow patients for several years to assess outcomes. Throughout the study, researchers will monitor participants event-free survival and progression-free survival for up to about 57 and 69 months, respectively. Additional assessments include side effect burden, patient-reported quality of life, treatment costs, treatment-free interval length, response times, and survival after second-line therapy. Regular evaluations will help determine how treatment interruption affects toxicity, dose intensity, and overall treatment outcomes over the long term.

This research focuses on patients with acute coronary syndrome ACS, a leading cause of death worldwide. It aims to create an ongoing registry to evaluate the long-term effects of diagnostics, treatments, and devices used for ACS in real-world clinical practice. The study addresses gaps left by traditional randomized controlled trials by capturing data from routine care and broader patient populations to improve cardiovascular care and quality of life. The study uses a nonrandomized observational design to collect detailed clinical and possibly genetic information from patients with ACS. This registry allows evaluation of various therapies, devices, and diagnostic tools used in daily practice. It also examines follow-up care pathways, risk score usage for medication duration, and adherence to treatment guidelines, aiming to enhance personalized medicine and secondary prevention. Participants provide information during routine clinical visits, with data collected prospectively and followed over time. Researchers monitor outcomes such as mortality, recurrent ischemic events, hospital admissions, and quality of life. The main measure is the number of participants tracked at three years. This long-term observation helps evaluate the effectiveness and safety of treatments in everyday clinical settings and supports ongoing improvements in ACS care.