Helmond

Physical restraints are still frequently used in about 20-25% of adult ICU patients in the Netherlands who are agitated or expected to become agitated, despite their harmful short- and long-term effects. This research evaluates the effectiveness of a person-centered multicomponent intervention (MCI) program that combines non-drug approaches with goal-directed light sedation using dexmedetomidine. The study compares this new approach with the traditional standard care that includes physical restraints, aiming to improve patient safety and outcomes during ICU stays. The intervention group will receive the MCI program, which involves non-pharmacological strategies and light sedation with dexmedetomidine as needed to manage agitation. This is compared against the current standard care involving physical restraints. The study focuses on adult ICU patients expected to stay longer than 24 hours and who show or are expected to show agitation within the first 14 days of ICU admission. The trial monitors short- and long-term outcomes as well as healthcare costs. Participants' involvement includes monitoring ICU-free days over 28 days as a primary outcome. Researchers will assess agitation levels, sedation needs, and the use of physical restraints. Safety and long-term effects will be tracked, with consent required for extended follow-up in related studies. The study excludes patients with certain neurological conditions, substance intoxication, or other risks, and requires participants or their relatives to understand Dutch for follow-up communication.

Researchers are evaluating chemotherapy dosing strategies for older patients aged 70 years and above who have metastatic colorectal cancer and are candidates for palliative chemotherapy. This phase III, open-label, randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy to see if the reduced dose is not worse in terms of progression-free survival (PFS). The study also examines secondary outcomes including severe toxicity, quality of life, physical function, overall survival, treatment cycles, dose reductions, hospital admissions, cumulative dosage, and cost-effectiveness. Participants are classified based on their risk of chemotherapy toxicity using the Geriatric 8 (G8) questionnaire. Those at low risk are randomized to receive either full-dose or 25% dose-reduced doublet chemotherapy (a fluoropyrimidine combined with oxaliplatin). Patients at high risk receive either full-dose or dose-reduced monotherapy with a fluoropyrimidine. Targeted treatments like bevacizumab or EGFR inhibitors may be added. Dose adjustments are made for moderate kidney impairment. Treatments are given on schedules involving oral and intravenous chemotherapy drugs administered every 2 to 3 weeks. During the study, participants undergo assessments including clinical evaluations, laboratory tests to monitor blood counts and organ function, and questionnaires for quality of life and physical functioning. Progression-free survival is tracked for at least one year after randomization. Researchers closely monitor treatment toxicity, hospitalizations, dose modifications, and survival. The total planned enrollment is 587 patients, with follow-up for safety and effectiveness throughout the treatment period.

This research evaluates the effectiveness of the RISE blended behavior change intervention in people who have experienced their first stroke. The study aims to prevent major adverse cardiovascular events such as recurrent stroke, transient ischemic attacks, acute coronary events, and cardiovascular death over a one-year follow-up period compared to standard care. It also investigates the intervention's impact on reducing sedentary behavior after hospital discharge in community-dwelling stroke survivors with sedentary movement patterns. Approximately 950 to 1000 participants are expected to be enrolled to account for loss to follow-up. Participants are randomly assigned to an experimental group receiving the 15-week RISE intervention alongside usual care or to a control group receiving only usual care. The RISE intervention involves coaching by a primary care physiotherapist who supports participants in balancing their 24-hour activity pattern, focusing on reducing and interrupting sedentary time to increase physical activity. This coaching includes the use of an activity monitor, a smartphone application with real-time feedback and e-learning modules, and a dashboard for the physiotherapist. Support from someone in the participant's social network is also included. Control group participants receive hospital-specific standard care. Participants will undergo assessments at baseline, immediately post-treatment (four months), and at six, nine, and twelve months after randomization. These assessments include wearing activity monitors, completing questionnaires, and performing physical tests, all of which are non-invasive and conducted either online or at home. Researchers monitor the occurrence of major adverse cardiovascular events as the primary outcome. The study's burden and risks are considered low, with physiotherapist visits conducted at home or online, and participants are physically capable of completing the required activities.

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.

Researchers are evaluating the use of a Bayesian network model called ENDORISK to improve preoperative risk assessment of lymph node metastasis in patients with early stage endometrial cancer. The study aims to see if using ENDORISK in daily clinical practice enhances risk stratification compared to standard care. This includes assessing patient decisions about lymph node evaluation and shared decision-making between patients and doctors. Participants receive personalized risk assessments for lymph node metastases using the ENDORISK model. Treatment plans, including hysterectomy with bilateral salpingo-oophorectomy and possible lymph node surgery, are tailored based on this risk. The study is conducted in two oncology regions using a stepped wedge design with one-year intervals between implementation phases. During the study, patients complete digital or paper questionnaires to evaluate preoperative information and shared decision-making outcomes. Researchers track the proportion of patients undergoing lymph node staging, positive predictive value for lymph node metastases, survival rates, quality of life, experiences with the ENDORISK model, and regional care costs. Follow-up continues up to 12 weeks post-operation to assess these outcomes.

Researchers are studying patients diagnosed with colorectal cancer, small bowel cancer, and anal cancer to better understand factors that affect treatment outcomes and survival. This study looks beyond tumor stage to explore how biochemical, genetic, environmental, and clinical factors may influence tumor recurrence and patient survival. It aims to address the gap in knowledge caused by most cancer patients not participating in clinical trials, and to validate trial results in a broader patient population. This is a prospective observational cohort study where data is collected from patients starting at their primary diagnosis and continuing until death. After informed consent, researchers gather detailed information on medical history, clinical status, imaging, pathology, tumor characteristics, treatments, hospital stays, side effects, and adverse events. Additional consent allows collection of patient-reported outcomes on quality of life and work ability, as well as biological materials like blood and tumor tissue for research and biobanking. Participants will be closely followed over time with ongoing data collection on treatment effects, clinical outcomes, and patient experiences. The study aims to provide accurate real-world data on various treatments and outcomes and to serve as a resource for future research into prognostic markers, new therapies, molecular studies, and health care policy. The main outcome measured is progression-free survival, tracked for up to 10 years, to better understand long-term treatment impact.

Researchers are investigating whether a generalist treatment approach called Guideline-Informed Treatment for Personality Disorders (GIT-PD) is as effective as specialist treatments, specifically Mentalization-Based Treatment (MBT) and Schema Therapy (ST), in improving personality functioning in patients with severe personality disorders. The study also aims to identify patient characteristics that predict who benefits more from each type of treatment. This is a pragmatic randomized controlled non-inferiority trial comparing generalist and specialist therapies for severe personality disorders. Participants are randomly assigned to receive either specialist treatment (MBT or ST) or generalist treatment (GIT-PD). MBT and ST are manualized, specialist psychotherapies lasting 12 to 24 months with at least 40 sessions, focusing on different therapeutic approaches. GIT-PD is a flexible, principle-driven treatment lasting 12 to 18 months and includes assessment, modular treatment (group or individual), and a follow-up phase focused on relapse prevention. Generalist treatment is designed to be less intensive than specialist therapies at the same site. During the trial, participants complete various questionnaires and semi-structured interviews at eight time points from enrollment through 30 months after treatment start. The study measures personality functioning using the Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0) and the Semi-structured Interview for Personality Functioning (STiP-5.1). These assessments help evaluate treatment effects and predict patient outcomes. Participants engage in their assigned therapy while researchers collect data before, during, and after treatment to monitor progress and safety.