Heerenveen

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are studying the gut microbiome in adults with metastasized or irresectable colorectal cancer CRC who are receiving chemotherapy. The study aims to understand how the gut microbiome changes during treatment and how these changes relate to the effects of chemotherapy. This research is important because even though treatments are improving, survival rates remain low and side effects are common, so better tools to predict treatment response are needed. Participants in this observational study will provide fecal samples at home before starting treatment and again three months after treatment begins, coinciding with their response evaluation. They will also fill out questionnaires about factors that may affect the microbiome, such as the use of antibiotics or proton pump inhibitors. Additionally, blood samples will be collected before treatment and three months later for storage and analysis. During the study, researchers will track participants response to chemotherapy and any serious side effects over two years. They will use various tests, including stool sample analysis, questionnaires, and blood tests, to gather data. The total duration of participation and follow-up extends for at least two years to help predict treatment outcomes and side effects based on microbiome changes.

Researchers are evaluating the effectiveness of two different doses of Atropine eye drops 0.05% and 0.5% in slowing the progression of axial length growth in European children aged 6 to 11 years with progressive myopia. The study aims to compare how well these doses prevent worsening of myopia, assess safety, adherence to treatment, and reasons why some children might not respond to the treatment. Progressive myopia can lead to serious eye problems, so preventing its advancement in childhood is important to reduce risks of vision loss later in life. Participants in this study will be randomly assigned to receive either Atropine 0.05% or Atropine 0.5% eye drops. They will administer one drop in each eye once daily at bedtime for 3 years. After this treatment phase, participants will be observed for an additional 2 years without treatment to monitor long-term effects. This design helps compare the two doses in terms of controlling eye growth and side effects over time. During the study, children will have their eye measurements taken to track axial length progression, visual function tests, and assessments of their response to treatment and any side effects. Researchers will also monitor adherence to the eye drop regimen and evaluate quality of life changes over 5 years. The primary outcome is the change in axial length after 3 years of treatment, with additional follow-up to 5 years. Safety and vision tests will be performed regularly to ensure participant well-being throughout the trial.

Researchers are evaluating the implementation of three evidence-based antibiotic stewardship strategies to improve treatment for neonates suspected of early-onset sepsis in Dutch hospitals. These strategies include the early-onset sepsis EOS calculator, procalcitonin PCT-guided therapy, and intravenous-to-oral switch therapy. While effective and safe, these practices are not yet used in all hospitals, leading to differences in clinical care. The study aims to assess the impact of actively implementing this bundle of interventions using a multicomponent approach across multiple centers. The study uses a prospective, multicenter, non-randomized pre-post design to compare clinical outcomes before and after implementing the stewardship strategies. Hospitals will collect retrospective clinical data on neonates from 12 months before and 12 months after the implementation period. Qualitative data will also be gathered through focus groups, interviews, and surveys to understand the effectiveness of the implementation methods. Participants are neonates born at 34 weeks gestation or later who are 0 to 3 days old at enrollment. Clinical data will be anonymized and analyzed to measure outcomes such as days on antibiotic therapy. The research team will monitor both clinical and implementation results to evaluate how the stewardship strategies affect care. The study is expected to run through June 2026 with ongoing observation of treatment practices and outcomes.

Researchers are investigating how various factors beyond tumor stage, such as biochemical, histopathological, genomic, environmental, and clinical characteristics, affect the outcomes of patients diagnosed with colorectal cancer CRC, small bowel cancer, and anal cancer. This observational study aims to collect detailed information from diagnosis through long-term follow-up to better understand prognosis and treatment effects in both early and late-stage cancers. The study addresses the gap between clinical trial populations and real-world patients by including a broader patient group treated in general practice. Participants will be followed prospectively from their initial diagnosis until death. Data collection includes medical history, clinical parameters, imaging, pathology, tumor details, treatments, hospital stays, interventions, and adverse events. With separate consent, patient-reported quality of life and work ability information will also be gathered. Additionally, biological samples obtained during routine care may be collected for further observational and molecular research. This cohort serves as a platform for evaluating new interventions through a Trials within Cohorts TwiCs design. Throughout up to ten years of follow-up, participants will undergo assessments of progression-free survival, disease-free survival, overall survival, and serious adverse events. Quality of life and work ability are assessed at intervals of 3, 6, 12, 24, 36, and 48 months. This extensive data collection supports a wide range of research aims including prognostic studies, molecular analyses, comparisons of new treatments, and health policy evaluations. The study provides a comprehensive view of treatment outcomes and patient experiences in everyday clinical settings.

Researchers are evaluating the follow-up care for patients with stage III non-small cell lung cancer NSCLC. The study compares overall survival over three years between patients who receive follow-up surveillance using 18F-Fluorodeoxyglucose Positron Emission TomographyComputerized Tomography 18F FDG PETCT and those who undergo conventional CT scan surveillance. This is to determine if the addition of 18F FDG PETCT scans improves early detection of cancer recurrence and impacts survival and quality of life. Participants are randomly assigned to two groups the intervention group receives usual care plus additional whole-body 18F FDG PETCT scans at 6, 12, 18, 24, and 36 months during follow-up, while the control group receives regular follow-up with physical exams and CT scans at least every six months for two years, then yearly until three years. After the 36-month period, all patients continue usual care with CT scans. The PETCT scans follow a specific low-dose protocol covering the skull to the mid-femoral region. During the study, participants complete quality of life questionnaires at each visit and may optionally participate in interviews and blood sample collection to assess secondary outcomes. Researchers measure overall survival at three years, recurrence detection, event-free survival, cost-effectiveness, and health-related quality of life. The study involves monitoring medical resource use and patient experiences, with results analyzed using survival curves and statistical tests over the three-year follow-up period.