Geldrop

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 the use of liquid biopsy (LB) techniques, including circulating tumor DNA (ctDNA), tumor markers (TMs), and circulating tumor cells (CTCs), for the diagnosis and monitoring of lung cancer (LC). The study aims to implement up-front ctDNA analysis as a routine part of diagnosing advanced-stage lung cancer patients in the Southeast Netherlands. This approach seeks to increase the molecular information available about tumors, reduce the number of tissue-based genetic tests, and shorten the time to treatment decisions. The study also focuses on developing decision support models that use ctDNA and other data to assist diagnosis, predict imaging results, and estimate survival. Additionally, a super-resolution microscopy test to detect PD-L1 expression on CTCs is being developed. This multicenter, prospective cohort study involves patients suspected of lung cancer. At diagnosis, participants have an extra 10 mL of blood drawn during routine venipuncture, with advanced-stage patients undergoing an additional 40 mL draw. Follow-up can last up to 36 months with up to 20 blood draws ranging from 10 to 40 mL each. The study integrates ctDNA analysis early in the diagnostic process and tracks its impact on identifying driver mutations, reducing tissue testing, and speeding therapeutic decisions. The study also develops and validates multiparametric decision support algorithms for lung cancer diagnosis and monitoring. Participants provide blood samples for genetic and biomarker analysis, and researchers collect data over up to three years. Outcome measures include the implementation of ctDNA analysis into routine care, the number of driver mutations identified compared to tumor tissue testing, and the development of decision support models for diagnosis and monitoring. Safety risks from blood draws are minimal. The study emphasizes improving personalized lung cancer care by using liquid biopsy data and advanced diagnostic tools over a long-term follow-up period.

Researchers are evaluating personalized blood thinner treatments after hip or knee replacement surgeries to reduce the risks of blood clots (venous thromboembolism or VTE) and bleeding. Currently, all patients receive the same standard blood thinner treatment, but some still develop blood clots while others experience bleeding. This study aims to see if adjusting the blood thinner dose and duration based on each patient's risk can lower these complications. Participants are divided into three groups based on their predicted risk of blood clots using a scoring system. Patients with low risk receive blood thinners only during their hospital stay. Those with intermediate risk are observed without changes to standard care. Patients with high risk get a higher dose and longer duration of blood thinners for six weeks. The blood thinners used include types such as LMWH or DOACs, given according to local guidelines and timing specified after surgery. Participants complete four questionnaires: one before surgery and three after surgery at 2 weeks, 6 weeks, and 3 months, to report any blood clots or bleeding events. If a participant experiences a clot, major bleed, or infection, an additional questionnaire about quality of life and joint function is sent one year later. No extra hospital visits are required. The main outcomes measured are blood clot and major bleeding events within 90 days after surgery.

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 evaluating AGN1 LOEP, a local osteo-enhancement procedure, to prevent secondary hip fractures in women with osteoporosis who have recently had a hip fracture repaired. This randomized controlled trial involves up to 2400 postmenopausal women aged 65 to 91 years who have experienced a low-energy fragility hip fracture and are undergoing surgical repair. The study aims to reduce the incidence of new fractures on the opposite hip, which is at risk during recovery. Participants are randomly assigned to one of two groups: the treated group receives standard hip fracture repair plus the AGN1 LOEP treatment on the unfractured opposite hip, while the control group receives only the standard repair without the AGN1 procedure. The AGN1 LOEP treatment involves injecting the implant material at the treatment site immediately after hip surgery. Follow-up visits are scheduled at 6 weeks, 6 months, and then every 6 months for at least 5 years to monitor outcomes. During the study, participants will undergo assessments to track the occurrence of secondary hip fractures and any adverse events, including serious complications. Researchers will collect data at multiple visits to evaluate the procedure's safety and effectiveness over time. The main outcomes measured include the cumulative incidence of new hip fractures and adverse events approximately 30 months after treatment, with long-term follow-up continuing for a minimum of five years.

Hip dysplasia is a common orthopedic problem where the shape or orientation of the hip joint bones is abnormal, often causing groin pain, difficulty walking, reduced strength, and early joint wear. The usual surgical treatment for adults is a peri-acetabular osteotomy (PAO), which is complex and has a high risk of serious complications, along with a long recovery. There is a need for safer, less invasive treatments that improve quality of life for these patients. This research is evaluating a new 3-dimensional shelf procedure using a custom-made 3D printed implant called the 3D-Shelf device. This implant aims to better fit and contain the hip joint compared to older techniques and be simpler and less invasive than the PAO surgery. The study focuses on the safety and early performance of this implant in adults with symptomatic hip dysplasia. Participants will be followed for 12 months with assessments of patient-reported outcomes at the start, 3, 6, and 12 months after surgery. The study will monitor clinical results, safety, and complication rates to compare whether the 3D-Shelf device is a safe alternative with similar or better outcomes than the standard PAO treatment.