Roermond

This trial studies men with low-volume, hormone-sensitive metastatic prostate cancer to evaluate if a shorter treatment duration with androgen receptor pathway inhibitors (ARPIs) like Apalutamide or Enzalutamide is as effective as continuous therapy. The purpose is to see if stopping ARPI treatment after 12 months, with the option to restart if the cancer progresses, can reduce side effects and costs without worsening outcomes. This is a Phase 3 randomized nationwide study focusing on patients with low-volume metastatic disease confirmed by imaging and clinical assessment. Participants will receive androgen deprivation therapy (ADT) combined with either continuous ARPI treatment or ARPI treatment stopped at 12 months. Those who stop ARPI after 12 months may restart treatment if their PSA levels rise, confirmed by a second test at least 4 weeks later. The study compares these two approaches to understand if shorter ARPI use is non-inferior to continuous use, aiming to reduce treatment toxicity while maintaining disease control. Participants will be followed for up to 6 years, with clinical progression-free survival as the main outcome. Researchers will monitor time from study inclusion to disease progression or treatment end. Patients will undergo regular assessments including PSA testing and clinical evaluations to track disease status. Safety and treatment effects will be closely observed throughout the study period, which includes up to 5 years of active follow-up after randomization.

Researchers are investigating treatment options for Crohn's disease (CD), a chronic condition with varied symptoms, relapse rates, and responses to therapy. This study compares the long-term effectiveness and safety of periodic adalimumab as an initial treatment against the standard step-up care that begins with corticosteroids. The goal is to prevent overtreatment in low-risk patients while improving outcomes and reducing side effects for those newly diagnosed with CD. Participants will receive either episodic subcutaneous adalimumab treatment for six months or the conventional step-up care starting with corticosteroids and progressing to other treatments if needed. The study monitors the impact of these approaches in newly diagnosed CD patients or those experiencing a flare, aiming to evaluate how well each treatment controls inflammation and maintains remission. Throughout the study, participants will be closely followed to assess treatment efficacy by measuring the number of yearly quarters of corticosteroid-free remission at week 96. They will use tools like myIBDcoach and have regular assessments including ileo-colonoscopy and small bowel imaging. Safety, disease control, and side effects will be monitored to understand the benefits and risks of these treatment strategies over time.

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 whether voice recordings or capnometry measurements, alone or combined with other non-invasive markers, can help detect emphysema on chest CT scans in people with chronic obstructive pulmonary disease (COPD). The study aims to develop a machine-learning algorithm that classifies the extent of emphysema based on voice and capnometry data. This is a cross-sectional, single-center study involving patients with COPD who have undergone routine clinical tests including pulmonary function tests and chest CT scans. Participants will perform various voice-related tasks such as paced reading, sustained vowels, coughing, and quiet breathing. They will also undergo capnometry measurements before and after a light exercise test called the 5-sit-to-stand (5-STS) test. These tests will be repeated after the exercise. The study will analyze speech features and capnometry data to build classification models to detect emphysema greater than 25% on CT scans. During the study visit, participants will complete voice tasks and capnometry measurements at rest and following exercise. Clinical data from previous pulmonary function tests and CT scans will be used. Researchers will also collect blood samples through venipuncture. The main outcomes include voice and capnometry measures and the presence of moderate to severe emphysema on CT. The total participation involves one visit for measurements and data collection with no long-term follow-up.

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 a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

Researchers are investigating how a combined exercise and nutritional program affects quality of life in patients with incurable cancer of the esophagus or stomach. These patients often face declining quality of life due to reduced muscle mass, physical ability, and nutritional health. The study aims to see if improving physical fitness and nutrition can help maintain or enhance their quality of life after first-line treatment has failed. This trial includes 196 patients with metastatic gastroesophageal cancer, who will be randomly assigned to receive either standard care or standard care plus the combined intervention. The intervention group participates in supervised exercise sessions twice a week for 12 weeks with a trained physiotherapist, focusing on aerobic and resistance training tailored to their fitness level. They also get guidance on increasing daily activity and receive an activity tracker to monitor movement. Every two weeks, a dietician assesses their nutritional status and provides personalized dietary advice based on cancer nutrition guidelines. Participants are encouraged to consume 15-25 grams of protein within 1-2 hours after exercise to support muscle health. The control group receives standard care without these additional interventions. Participants will be involved in the study for up to one year, with quality of life evaluated at the start, after 6 weeks, and then every 12 weeks. Assessments include questionnaires related to their physical and nutritional status, tracking of daily activity, and ongoing monitoring of their well-being. Safety and adherence are carefully observed, with the study designed to understand both the benefits and any risks of this combined approach in this vulnerable patient group.