Emmen

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 evaluating chemotherapy dosing strategies in older patients aged 70 years and above who have metastatic colorectal cancer and are eligible for first-line palliative chemotherapy. This phase III randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy, focusing on progression-free survival PFS. Patients are assessed using the Geriatric 8 G8 questionnaire to determine their risk of chemotherapy toxicity, which guides treatment assignment. The study seeks to balance treatment effectiveness with minimizing toxicity, hospital admissions, and maintaining quality of life QoL and physical functioning. Participants classified as low risk for toxicity G8 score 15 or higher are randomized to receive either doublet chemotherapy a fluoropyrimidine combined with oxaliplatin at full dose or with a 25% dose reduction upfront. Those at high risk G8 score 14 or lower or judged high risk by their oncologist receive fluoropyrimidine monotherapy either at full dose or with a 25% dose reduction. The study also allows the addition of targeted treatments like bevacizumab or EGFR inhibitors. Dose adjustments are made for patients with moderate kidney impairment. Chemotherapy is given orally or intravenously on schedules varying between every two and three weeks, depending on the regimen. Participants will be closely monitored throughout treatment, with assessments including radiological or clinical evaluations for disease progression, quality of life and physical functioning questionnaires at 1, 3, 6, and 12 months, and tracking of chemotherapy toxicity, overall survival, treatment cycles, dose changes, hospital admissions, and cumulative drug dosage. Safety and cost-effectiveness will also be evaluated over an average study duration of eight months and up to one year for some outcomes. The study plans to include 587 patients and will continue until December 2028.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

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.

Researchers are studying the gut microbiome in adults with metastasized or irresectable colorectal cancer CRC who are receiving chemotherapy. The study aims to understand how the gut microbiome changes during treatment and how these changes relate to the effects of chemotherapy. This research is important because even though treatments are improving, survival rates remain low and side effects are common, so better tools to predict treatment response are needed. Participants in this observational study will provide fecal samples at home before starting treatment and again three months after treatment begins, coinciding with their response evaluation. They will also fill out questionnaires about factors that may affect the microbiome, such as the use of antibiotics or proton pump inhibitors. Additionally, blood samples will be collected before treatment and three months later for storage and analysis. During the study, researchers will track participants response to chemotherapy and any serious side effects over two years. They will use various tests, including stool sample analysis, questionnaires, and blood tests, to gather data. The total duration of participation and follow-up extends for at least two years to help predict treatment outcomes and side effects based on microbiome changes.

Sexual dysfunction often occurs after radical prostatectomy RP for prostate cancer and can significantly affect quality of life. Testosterone levels naturally decline with age, and about 30% of men over 70 have testosterone deficiency TD. This study evaluates the effects of testosterone replacement therapy TRT on sexual function and cancer outcomes in men with TD after RP for prostate cancer. Participants are randomly assigned to receive either a daily topical testosterone gel or a placebo gel starting within 8 weeks after RP. The treatment lasts for one year, with dosage adjustments possible based on clinical response. This phase 3 trial includes a one-year monitoring period for functional outcomes and an additional four years of follow-up to assess five-year biochemical recurrence-free survival. During the study, participants will have regular blood tests and complete online questionnaires over 24 months to assess sexual, urinary, and hormonal function. Researchers will measure changes in sexual function scores using the EPIC-26 questionnaire at 3, 12, and 24 months after RP, as well as urinary incontinence, hormonal function, and cancer recurrence rates over five years. Side effects and safety will be monitored throughout the study period.

Researchers are investigating the effectiveness of adding liothyronine LT3 to levothyroxine LT4 treatment in patients with autoimmune hypothyroidism who continue to experience severe tiredness despite having normalized thyroid hormone levels on LT4 alone. This study addresses the problem that LT4 monotherapy may not fully replicate the natural balance of thyroid hormones, as healthy individuals produce some T3 directly. The trial also explores whether certain genetic factors influence response to combination therapy. The study begins with a run-in period where all participants switch to a standardized generic LT4 to stabilize thyroid hormone levels. After confirming normal TSH levels and persistent tiredness, participants enter a one-year randomized, double-blind trial comparing LT4LT3 combination therapy to LT4 with placebo. The LT4LT3 group takes LT4 once daily and LT3 twice daily at a set ratio. Visits occur at baseline and multiple times over the year to adjust doses and monitor health. Participants undergo physical exams, ECGs, blood tests, and complete questionnaires about tiredness, quality of life, and medical resource use throughout the study. Additional measures include bone markers, scans, cardiovascular and metabolic assessments, and neurocognitive tests in subgroups. The main outcome is the change in tiredness scores over 52 weeks, with safety and genetic factors also evaluated. The total study duration includes the run-in and treatment phases, lasting several months to over a year.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.

Researchers are evaluating two diagnostic approaches for patients suspected of having muscle-invasive bladder cancer MIBC. This trial compares the standard care method, Transurethral Resection of the Bladder Tumor TURBT, with a newer approach using multiparametric MRI mpMRI followed by a same-day cystoscopic bladder biopsy. The study aims to assess progression-free survival, time to definitive treatment, and cost-effectiveness over two years. Participants will be randomly assigned to one of two groups one undergoing mpMRI plus same-day cystoscopic bladder biopsy, and the other receiving TURBT with blood samples taken shortly before and after the procedure. Both groups will be monitored and compared for their diagnostic outcomes and related healthcare costs. Throughout the study, participants will have regular evaluations including assessments of progression-free survival, quality of life, healthcare costs, and circulating tumor cells before and after TURBT. The main outcome measure is progression-free survival at two years. The study involves multiple centers and aims to provide detailed information on the effectiveness and cost implications of these diagnostic strategies.