Zaandam

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

Researchers are investigating the impact of psychological guidance on patients with neuroticism who have undergone surgery for proximal humerus fractures. The study focuses on whether adding focused cognitive behavioral therapy to standard care can improve functional outcomes, reduce pain and anxiety, and enhance overall health. Mental vulnerability related to neuroticism has been linked to poorer health outcomes, and this trial aims to address this gap by providing psychological support. Participants are randomly assigned to one of two groups one receiving standard postoperative care including surgery, pain management, outpatient visits, and physical therapy the other receiving the same standard care plus eight sessions of psychological guidance over six months. The therapy sessions include psychoeducation, relaxation techniques, coping strategies, and are delivered by licensed psychologists either in-person or via videocall. During the study, participants will be assessed at 3, 6, and 12 months after surgery using various measures including the Constant Shoulder Score, Oxford Shoulder Score, pain levels, range of motion, psychological factors like anxiety and resilience, and general health. Safety monitoring includes tracking adverse events throughout the follow-up period. The total participation duration spans one year with multiple evaluations to monitor recovery and psychological changes.

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 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 comparing robot-assisted radical prostatectomy RARP and external beam radiotherapy EBRT, sometimes combined with androgen deprivation therapy ADT, for men with high-risk non-metastatic prostate cancer. The study aims to understand differences in quality of life, functional outcomes, cost-effectiveness, progression-free survival, and distant metastasis-free survival. There is currently no clear consensus on which treatment is better, leading to variation in hospital practices. Participants will receive either RARP, which may include pelvic lymph node dissection and possibly adjuvant radiotherapy or androgen deprivation therapy, or EBRT delivered at an effective radiation dose, possibly combined with a brachytherapy boost and pelvic lymph node dissection. Positive lymph node findings will not exclude participants and may be treated with lymph node irradiation. Treatment details vary based on clinical decisions. During the study, participants will be followed for up to five years, with key assessments at three years including health-related quality of life and functional outcomes. Cost-effectiveness will also be evaluated at three years, while progression-free and distant metastasis-free survival will be tracked up to five years. The study involves regular monitoring to gather these outcomes and support shared decision-making for future patients.

Pelvic fragility fractures in elderly patients often lead to serious health problems and high death rates. Currently, treatment approaches vary widely due to the lack of a standard protocol. This trial evaluates a new clinical pathway based on evidence and expert experience, aiming to improve outcomes for this vulnerable group who face multiple risks for poor recovery. The study compares the usual care with an evidence-based clinical pathway designed to guide diagnosis and treatment strategies. Patients will be randomly assigned to either continue with standard care or follow this best-practice clinical pathway. The pathway focuses on early diagnosis and minimally invasive treatments tailored for fragile patients. Participants will be monitored over time to assess their mobility, daily function, quality of life, pain levels, medication use, complication rates, and mortality. Assessments use tools like the Parker mobility score, Elderly mobility scale, Katz Index, EuroQol quality of life questionnaire, and pain rating scales. Follow-ups occur at multiple intervals up to two years, with careful tracking of recovery and any additional injuries or complications.

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 investigating how various factors beyond tumor stage, such as biochemical, histopathological, genomic, environmental, and clinical characteristics, affect the outcomes of patients diagnosed with colorectal cancer CRC, small bowel cancer, and anal cancer. This observational study aims to collect detailed information from diagnosis through long-term follow-up to better understand prognosis and treatment effects in both early and late-stage cancers. The study addresses the gap between clinical trial populations and real-world patients by including a broader patient group treated in general practice. Participants will be followed prospectively from their initial diagnosis until death. Data collection includes medical history, clinical parameters, imaging, pathology, tumor details, treatments, hospital stays, interventions, and adverse events. With separate consent, patient-reported quality of life and work ability information will also be gathered. Additionally, biological samples obtained during routine care may be collected for further observational and molecular research. This cohort serves as a platform for evaluating new interventions through a Trials within Cohorts TwiCs design. Throughout up to ten years of follow-up, participants will undergo assessments of progression-free survival, disease-free survival, overall survival, and serious adverse events. Quality of life and work ability are assessed at intervals of 3, 6, 12, 24, 36, and 48 months. This extensive data collection supports a wide range of research aims including prognostic studies, molecular analyses, comparisons of new treatments, and health policy evaluations. The study provides a comprehensive view of treatment outcomes and patient experiences in everyday clinical settings.

This research investigates a treatment approach for low-risk breast cancer in female patients aged 50 and above. The study evaluates the effects of a single-dose preoperative partial breast radiotherapy guided by MRI, aiming to measure the rate of complete tumor disappearance at the time of surgery, which occurs between six and twelve months after radiotherapy. Researchers will also monitor tumor response through MRI scans and blood and tumor tissue markers to predict this outcome. Patients receive a single dose of radiotherapy targeting the tumor area, with doses of 20Gy to the gross tumor volume and 15Gy to the clinical tumor volume. Surgery to conserve the breast is planned around 12 months after radiotherapy if MRI shows a complete response. If MRI indicates an incomplete response or disease progression, surgery may be moved earlier, around six months or sooner. During the months between radiotherapy and surgery, MRI scans occur every three months to monitor tumor response. Participants will be assessed regularly using MRI scans and various blood and tissue tests to follow tumor changes and treatment effects. After surgery, patients will be followed for up to 10 years to evaluate cancer outcomes, side effects, cosmetic results, and quality of life. The primary measure is the complete pathological response at 12 months post-radiotherapy, with secondary measures including radiologic response, adverse events, quality of life, cosmetic outcomes, recurrence rates, survival, and biomarkers related to radiotherapy effects.

Researchers are evaluating the impact of a combined exercise and nutrition program on quality of life in patients with incurable gastroesophageal adenocarcinoma, particularly after their first-line cancer treatment has failed. This study focuses on patients with metastatic or recurrent disease, aiming to address declines in muscle mass, physical ability, and nutritional health, which can worsen quality of life. The trial seeks to understand whether improving physical capacity and nutrition can benefit patients in this challenging condition. Participants will be randomly assigned to one of two groups one receiving standard medical care, including nutritional support and general advice on physical activity the other receiving this usual care plus a 12-week intervention involving supervised exercise sessions twice weekly with an oncology physiotherapist and biweekly nutritional assessments by a dietician. The exercise includes aerobic and resistance training tailored to individual fitness, alongside education to increase daily activity, supported by activity trackers. Nutritional guidance follows established cancer-related nutrition guidelines, emphasizing protein intake post-exercise. Throughout the study, participants will complete questionnaires on quality of life at baseline, 6 weeks, and every 12 weeks up to one year. Measures such as aerobic capacity, muscle strength, body composition, nutritional status, physical activity levels, and treatment effects will be regularly assessed. The trial also monitors treatment toxicity, progression-free and overall survival, and performance status. The full observation period extends up to one year after the intervention, ensuring comprehensive evaluation of outcomes and safety.