Terneuzen

Researchers are evaluating the safety and effectiveness of low-dose and high-dose atogepant in children and adolescents aged 6 to 17 who experience episodic migraine. Migraines are moderate to severe headaches often accompanied by symptoms such as throbbing pain, nausea, and sensitivity to light and sound. While several treatments exist for adults, options for younger patients are limited, making this Phase 3 study important to understand how atogepant works in this younger population. Participants aged 6 to 17 will be randomly assigned to one of six groups to receive either placebo, low-dose atogepant, or high-dose atogepant tablets taken once daily by mouth for 12 weeks. The exact doses for children aged 6 to 11 will be decided after a pharmacokinetic substudy. After 12 weeks, participants may either have a follow-up visit 4 weeks after stopping the treatment or join an extension study to continue taking atogepant for an additional 52 weeks. During the study, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and to monitor for any side effects. They will also complete questionnaires to evaluate how treatment affects their migraines. The main outcomes measured are changes in the number of monthly migraine days over 12 weeks and the number of participants experiencing adverse events during the first 16 weeks. About 450 participants will be enrolled across roughly 100 sites worldwide.

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.

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 follow-up care schedules after total hip or knee replacement surgery in adults aged 50 and older. The study aims to determine if reducing routine follow-up visits, specifically the 1-year appointment, is safe and effective compared to standard care. The goal is to potentially lower the number of unnecessary hospital visits and reduce the burden on patients, caregivers, and healthcare professionals, while revising current clinical guidelines accordingly. Participants receive one of two follow-up care plans: Routine Follow-Up (RFU), which includes scheduled X-rays and clinical visits at 3 months and 1 year after surgery; or Check-Up on Demand (COD), which involves a scheduled visit at 3 months and an additional 1-year visit only if requested by the patient or healthcare provider. This study is part of a larger trial consisting of three work packages, with this segment focusing on follow-up during the first year after surgery. During the study, participants' physical function is assessed using PROMIS Physical Function measures before surgery and at 3, 12, 15, 18, and 24 months post-surgery. Researchers also track the number of clinical visits and X-rays from surgery until 24 months later. Patients complete questionnaires and clinical evaluations, with ongoing monitoring to ensure safety and capture any additional follow-up visits as needed.

Researchers are studying breast cancer patients who have cancer that has spread to lymph nodes and are treated with neoadjuvant systemic therapy (NST), which includes chemotherapy and sometimes immunotherapy. The study focuses on how to best check and treat the lymph nodes after NST, comparing less invasive methods to the traditional axillary lymph node dissection (ALND). The goal is to see if less invasive techniques can offer similar cancer control and quality of life benefits. This multicenter observational study includes patients with positive lymph nodes who receive NST followed by breast and axillary treatment. Data on patient characteristics, tumor details, staging before and after NST, and treatments will be collected into a national database. Patients will complete quality of life questionnaires at diagnosis, and then 1 and 5 years later to understand the impact of different axillary treatment strategies. Participants will be followed for 5 years to evaluate disease-free survival, breast cancer-specific survival, overall survival, and rates of cancer returning in the lymph nodes. Quality of life will be measured using multiple questionnaires over time. The study aims to provide evidence to improve national guidelines and support shared decision-making about axillary treatment options for node positive breast cancer patients.

This research focuses on patients with borderline resectable (BR) and locally advanced pancreatic ductal adenocarcinoma (LAPDA) undergoing neoadjuvant chemotherapy with FOLFIRINOX. The study aims to assess whether combining diffusion-weighted magnetic resonance imaging (DW-MRI), radiomics, and multi-omics profiling from liquid biopsies can better predict successful surgical removal of the tumor. It addresses the challenge that standard CT imaging and tumor marker CA 19-9 lack accuracy in predicting if surgery will be successful, potentially leading to unnecessary operations or missed treatment opportunities. Participants will receive standard care, including chemotherapy and routine CT imaging, along with additional DW-MRI scans and blood samples for advanced genetic and molecular analysis before and after chemotherapy. The study includes one treatment arm and uses specialized imaging and genetic tests to analyze tumor response and progression. If no tumor progression is detected and tumor markers decrease, patients will be considered for surgery, during which further blood samples will be collected to study circulating tumor cells. Throughout the study, participants will undergo imaging, blood tests, and complete questionnaires about their health and quality of life. Researchers will measure outcomes such as surgical resectability, cancer recurrence, and survival over two years. The study aims to refine surgical decision-making, reducing unnecessary surgeries and improving patient outcomes while monitoring safety and treatment responses for up to five years.

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 the safety and effectiveness of the Supraflex Family sirolimus-eluting coronary stent system in patients with coronary artery disease. This study focuses on a 'real-world' population requiring stent implantation, aiming to understand the performance of this new generation biodegradable polymer stent that uses a cobalt-chromium platform for better flexibility and deliverability compared to earlier stainless steel models. The study involves patients who receive at least one Supraflex Family sirolimus-eluting stent as part of their planned clinical care. The stent's design includes a biodegradable polymer coating on a cobalt-chromium platform, intended to improve long-term safety and ease of use during procedures. Participants will be monitored to measure outcomes such as Target Lesion Failure over 12 months. The study includes follow-up visits to assess participant health and stent performance, with data collected on safety and efficacy. The total duration of monitoring is at least 12 months after stent implantation to evaluate the long-term results.