Helmond

Researchers are evaluating a person-centered multicomponent intervention program to prevent and reduce agitation and the use of physical restraints in adult patients in intensive care units ICUs. This program combines non-drug approaches with light sedation guided by the drug dexmedetomidine. The study aims to compare this approach with the usual care that includes physical restraints, focusing on both short- and long-term patient outcomes and healthcare costs. The study involves two groups one receiving the multicomponent intervention program, which uses non-pharmacological methods combined with goal-directed light sedation using dexmedetomidine when needed, and the other receiving standard care that may include physical restraints. The intervention is designed for adult ICU patients who are agitated or expected to become agitated during their ICU stay. Participants will be monitored for various outcomes including ICU-free days within 28 days, rates of device removal, reintubations, days with delirium or coma, use of physical restraints and sedative drugs, duration of mechanical ventilation, hospital stay length, mortality at multiple time points, as well as physical, mental, cognitive outcomes and quality of life up to 24 months. Safety and cost-effectiveness will also be evaluated. The total follow-up may extend up to one year or more, with detailed assessments at several time points.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

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 effectiveness of the RISE blended behavioral intervention in people who have had a first stroke. The study aims to prevent major adverse cardiovascular events such as recurrent stroke, transient ischemic attack TIA, acute coronary events, and cardiovascular death over a one-year follow-up, compared to standard care. The study also examines the cost-effectiveness of the intervention and its impact on reducing sedentary behavior in community-dwelling stroke survivors with sedentary movement patterns. Participants are randomly assigned to either the experimental group receiving the 15-week RISE intervention alongside usual care or the control group receiving usual care only. The RISE intervention involves coaching by a primary care physiotherapist using behavior change techniques and the RISE eCoaching system, which includes an activity monitor, smartphone app with real-time feedback and e-learning modules, and a monitoring dashboard for the physiotherapist. Participants also receive support from someone in their social network. Usual care follows hospital-specific guidelines. Participants will be involved in baseline, post-treatment four months, and follow-up assessments at six, nine, and twelve months after randomization. These include wearing an activity monitor, completing questionnaires, and performing physical tests. Researchers measure major adverse cardiovascular events, 24-hour activity patterns including sedentary behavior, physical activity, and sleep, as well as cost-effectiveness, quality of life, healthcare utilization, and productivity losses. The study is designed to minimize burden with home or online sessions and non-invasive assessments, lasting approximately 3.5 hours per measurement period.

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.

Researchers are evaluating the use of the ENDORISK Bayesian network model to improve preoperative risk assessment for lymph node metastasis in patients with early stage endometrial cancer. This study aims to see if implementing ENDORISK in everyday clinical practice enhances risk stratification compared to the current standard care. The study also looks at patient information sharing, treatment decisions, survival outcomes, quality of life, clinician experiences, and healthcare costs. Participants are divided into two groups a control group receiving standard care based on prior data, and an intervention group using the ENDORISK model to receive personalized risk assessments and treatment plans including hysterectomy with or without lymph node surgery. The model is applied during preoperative counseling to guide treatment decisions. The study is conducted over several years in two oncology regions, with the intervention introduced sequentially. During the study, participants will undergo lymph node staging if indicated, and complete questionnaires about information provision and shared decision-making up to 12 weeks after surgery. Researchers will monitor the proportion of patients choosing lymph node assessment, positive predictive value of detected metastases, survival rates over 5 years, health-related quality of life at 12 weeks and 12 months, treatment-related morbidity, clinician feedback, and regional care costs. The study starts in October 2025 and continues through October 2032.

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.

Researchers are evaluating whether generalist treatment GIT-PD is not less effective than specialist treatments like Mentalization-Based Treatment MBT or Schema Therapy ST in improving the level of personality functioning in adults with severe personality disorders. The study also aims to find out which patient characteristics predict better responses to either specialist or generalist treatment. This pragmatic randomized controlled trial compares these approaches to help understand treatment options for severe personality disorders. Participants will be randomly assigned to receive either specialist treatmentMBT or ST, depending on availability and patient needsor generalist treatment following the Guideline-Informed Treatment for Personality Disorders GIT-PD. Specialist treatments require a minimum of 40 sessions or 12 to 24 months duration, while GIT-PD is a flexible, principle-driven approach lasting 12 to 18 months with assessment, modular treatment, and relapse prevention phases. Each site must offer both treatments, with GIT-PD being less intensive than the specialist therapies at that location. During the study, participants will complete various questionnaires and interviews at eight time points from enrollment through 30 months after starting treatment. Measurements include the Level of Personality Functioning Scale and the Semi-structured Interview for Personality Functioning, among others. Researchers will monitor symptoms, disability, quality of life, and treatment costs. This long-term follow-up allows detailed analysis of how each treatment affects personality functioning over time.