Hoorn

Researchers are evaluating a "wait-and-see" approach for patients with rectal cancer who respond completely to neoadjuvant chemoradiotherapy. This study aims to provide both short-term and long-term data on cancer control and patient function when surgery is avoided in good responders. The research also seeks to establish a national network of expert centers to improve organ-preserving care and create a registry to gather more evidence about this treatment strategy. The standard treatment for locally advanced rectal cancer typically involves chemoradiotherapy followed by surgery. In this study, patients who show a complete clinical response after treatment will be observed without immediate surgery under a "wait-and-see" policy. The study is a multicenter prospective observational cohort and implementation study, focusing on patients aged 18 or older who have had a long course of chemoradiotherapy or a short course with a long waiting interval. The main goal is to track disease-free survival without tumor regrowth over two years. Participants will be closely monitored using clinical exams, endoscopy, and advanced MRI scans to confirm their response and detect any regrowth early. Researchers will measure outcomes such as two-year disease-free survival, regrowth rate, local control, overall survival, quality of life, and the ability of centers to provide high-quality organ preservation care. Patients will undergo intensive follow-up to ensure safety and gather comprehensive data on the effects of this less invasive approach over time.

Researchers are evaluating the safety and effectiveness of the Supera Vascular Mimetic Implant, a special stent designed to treat narrowed or blocked areas in the common femoral artery, compared to traditional surgical removal of artery plaque (endarterectomy). This study focuses on patients with Peripheral Arterial Disease classified as Rutherford category 2, 3, or 4. The goal is to see if the implant is at least as effective as surgery and possibly safer for patients. Participants are randomly assigned to one of two groups: one receiving the Supera stent through a minimally invasive procedure involving balloon dilation and stent placement, and the other undergoing standard surgical endarterectomy. The procedure involves crossing the lesion with a guidewire, angiographic assessment, and optional post-dilation for the stent group. The surgery group receives treatment according to standard care. Follow-up visits are scheduled at 1, 6, 12, 24, and 36 months after the procedure. Throughout the study, patients will undergo assessments including physical exams, walking ability questionnaires, blood tests, ankle and toe blood pressure measurements, and ultrasound imaging to check blood flow. Researchers will monitor for outcomes such as artery openness (patency), need for additional treatments, wound healing, and any adverse events up to 36 months. Primary outcomes focus on artery openness at 12 months and safety within 30 days post-procedure.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

This research aims to optimize the implant position in reverse shoulder arthroplasty by comparing Exactech Guided Personalized Surgery (GPS) technology with conventional instrumentation techniques. The study also evaluates how the implant position affects range of motion (ROM) and patient-reported outcomes. Patients will be followed for a minimum of 2 years, with long-term follow-up extending up to 10 years. Participants will undergo reverse shoulder arthroplasty using either the GPS system or conventional surgical tools. All patients must have a preoperative CT scan within 3 months before surgery. The study involves multiple centers and uses a randomized design to compare the two surgical approaches. During the study, participants will be assessed on several outcome measures including SST-12, SPADI, Constant, ASES, and UCLA scores, with these assessments occurring about once per year throughout the study. Patients must comply with all pre- and postoperative visits and follow-up requirements. The research team will monitor patient progress and implant function over the study duration to understand the impact of implant positioning on shoulder function and quality of life.

Researchers are evaluating the (cost)effectiveness of the Occupational Therapy at Home E-Rehabilitation (OTHER) intervention compared to usual occupational therapy care in older adults recovering from stroke. The study focuses on community-dwelling persons aged 60 and older in geriatric rehabilitation, aiming to improve self-perceived performance in daily activities, satisfaction with performance, physical activity, and self-management over 26 weeks. It also explores participant and therapist experiences with the intervention and investigates factors affecting its delivery and benefits. The OTHER intervention involves occupational therapists using activity monitoring, coaching, and videoconferencing to support the transition from clinical care to home. Participants receive this treatment over a 24-week period, with assessments at weeks 4, 13, and 26. The study compares this approach to standard occupational therapy to determine differences in outcomes such as daily functioning and quality-adjusted life years. Participants will be involved in regular evaluations including the Canadian Occupational Performance measure at three time points to track changes in daily activity performance. Researchers will monitor treatment fidelity, barriers, facilitators, and cost-effectiveness. The study includes qualitative assessments to understand experiences of stroke survivors and therapists and their reflections on the intervention. Total participation lasts for about 26 weeks with ongoing monitoring.

Researchers are evaluating the feasibility and safety of permissive lung-protective ventilation in critically ill adults who require invasive mechanical ventilation due to acute hypoxemic respiratory failure. This pilot study aims to inform the design of a future larger randomized clinical trial. The study compares a lower respiratory rate ventilation strategy that allows mild hypercapnia with a conventional lung-protective ventilation approach maintaining normal blood gas levels. Both strategies are considered standard care in intensive care units, and the study focuses on patients expected to be ventilated for more than 24 hours. Participants are randomly assigned to one of two groups. The intervention group receives permissive lung-protective ventilation, where the respiratory rate is gradually reduced stepwise, guided by arterial blood gas analysis and continuous carbon dioxide monitoring, targeting a partial pressure of carbon dioxide up to 8.5 kPa and arterial pH above 7.20. The respiratory rate is decreased every 10 minutes until reaching a minimum of 4 breaths per minute, continuing until spontaneous breathing begins. The control group follows conventional lung-protective ventilation with respiratory rates adjusted to maintain normal carbon dioxide and pH levels. Blood gas analyses are performed hourly for six hours after randomization and then every eight hours during nursing shifts. During the study, patients are monitored from the start of mechanical ventilation until the first extubation for up to 28 days. Researchers collect demographic, ventilation, and outcome data without additional harm beyond standard care. Safety is assessed by monitoring for unacceptable hypercapnia, hypoxemia, and ventilator-associated complications. The primary outcome is the feasibility of the intervention, measured by the difference in respiratory rates between groups. Secondary measures include protocol compliance and data collection feasibility. The total participation duration depends on ventilation length and clinical progress.

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 treatments for men with high-risk non-metastatic prostate cancer to compare robot-assisted radical prostatectomy (RARP) and external beam radiotherapy (EBRT), which may be combined with androgen deprivation therapy (ADT). This study aims to understand which treatment better supports health-related quality of life, functional outcomes, cost-effectiveness, progression-free survival, and distant metastasis-free survival. Currently, there is no clear consensus on the optimal treatment, leading to varied use of these options across hospitals. The study examines these two common treatment methods for high-risk prostate cancer. Both RARP and EBRT (with or without ADT) have side effects that can affect patients' quality of life. By collecting detailed data on outcomes and costs, the study seeks to provide evidence to guide treatment choices and improve shared decision-making between patients and healthcare providers. Participants will be followed for at least three years after starting treatment. During this time, researchers will assess functional outcomes and health-related quality of life. These long-term measures will help determine how each treatment impacts patients over time, supporting better personalized care and informing national guidelines.

Patients with pelvic fragility fractures often face serious health risks and complications. This research focuses on implementing a clinical treatment pathway based on evidence and expert opinions to improve care for elderly patients with these fractures. The study aims to address the current lack of standardized treatment protocols and reduce the poor outcomes seen in this vulnerable group. The study evaluates a clinical pathway that guides diagnosis and treatment strategies for pelvic fragility fractures caused by low-energy trauma. This pathway is designed to standardize care across multiple centers involved in the trial. The intervention involves applying this newly developed clinical protocol during patient care to assess its impact on outcomes. Participants will be monitored using the Parker Mobility Score to track changes in mobility from the start of the study through 2 weeks, 3 months, 6 months, and 1 year after treatment. The study includes patients presenting at emergency rooms or outpatient clinics in participating hospitals. Researchers will assess improvements in mobility and overall patient outcomes following the implementation of the clinical pathway.

Researchers are evaluating how to introduce a new method using indocyanine green (ICG) dye and a special camera to locate the sentinel lymph node during breast cancer surgery. The sentinel lymph node is the first node where cancer may spread. The current standard uses a radioactive tracer called technetium-99m (99mTc), which requires extra hospital visits and exposes patients to radiation. ICG offers advantages like no radiation, no extra visits, and lower costs but is not yet widely used in the Netherlands due to unfamiliarity and uncertainty about switching methods. The study involves three phases across several Dutch hospitals: Phase I uses the current 99mTc method only; Phase II uses both 99mTc and ICG together; and Phase III uses ICG only. During surgery, ICG is injected after anesthesia and before the lymph node is removed, with imaging to guide the procedure. In Phase II, the surgeon confirms findings with the radioactive tracer, while Phase III fully relies on ICG. The hospitals will implement these phases step-by-step following a planned schedule. Participants undergo the sentinel lymph node biopsy as part of their planned breast cancer surgery, with no extra hospital visits. After surgery, they complete a short 10-15 minute questionnaire about their experience. Researchers will collect data from hospital records and surveys to measure how well ICG is adopted, patient satisfaction, safety, and effectiveness. The study aims to create a standardized protocol and educational materials to support nationwide adoption of ICG for sentinel lymph node biopsy.