Heerenveen

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are studying the changes and characteristics of the gut microbiome during chemotherapy in patients with metastatic or irresectable colorectal cancer (CRC). The study aims to explore how the gut microbiome relates to the effects of chemotherapy, as current treatments have limited overall survival and significant side effects. Understanding the microbiome could help improve treatment selection and effectiveness for CRC patients undergoing systemic anti-tumor therapy. Participants will collect fecal samples at home before starting treatment and three months after treatment begins, coinciding with response evaluations. They will also fill out questionnaires about factors that might affect the microbiome, such as antibiotic or proton pump inhibitor use. Additionally, blood samples will be collected before treatment and three months later for storage and analysis. Treatments include any combination of chemotherapy with or without anti-VEGF or anti-EGFR therapy. During the study, researchers will monitor changes in the gut microbiome and evaluate the patients' response to chemotherapy over two years. Outcome measures include prediction of response to conventional systemic anti-tumor therapy. Participants must provide informed consent and comply with study procedures, including sample collection and questionnaires. The study focuses on improving understanding of the microbiome's role in treatment outcomes and safety in metastatic or irresectable CRC.

Researchers are investigating the effectiveness of two different concentrations of Atropine eye drops, 0.05% and 0.5%, in slowing the progression of axial length in European children aged 6 to 11 years with progressive myopia. Progressive myopia is increasing worldwide and can lead to serious complications such as myopic macular degeneration, retinal detachment, and glaucoma, which may cause low vision or blindness. The study aims to compare the safety, adherence, and reasons for nonresponse to these treatments over a long period. Participants will receive either Atropine 0.05% or Atropine 0.5% eye drops daily for three years. After this treatment phase, there will be a two-year observational follow-up period without study medication to monitor the longer-term effects. The study is double-masked and randomized, meaning neither the participants nor the researchers know which treatment is being given, to ensure unbiased results. During the study, children will undergo regular assessments including measurements of axial length to track eye growth, vision tests, and monitoring for side effects or adherence to the treatment. The main outcome measured is the change in axial length from the start of the study to 36 months. Researchers will also evaluate safety and reasons why some children might not respond to the treatment. The total participation lasts five years, including treatment and observation.

Researchers are evaluating treatments for patients with resectable pancreatic cancer in the PREOPANC-3 study, a randomized, multicenter, phase 3 clinical trial. The trial aims to compare whether giving mFOLFIRINOX chemotherapy before and after surgery (perioperative) improves overall survival compared to giving mFOLFIRINOX only after surgery (adjuvant). Pancreatic ductal adenocarcinoma patients eligible have tumors that can be surgically removed without metastasis and meet specific health criteria. Participants are randomly assigned to one of two groups. One group receives 8 cycles of neoadjuvant mFOLFIRINOX chemotherapy followed by pancreatic surgery (either open or minimally invasive pancreatectomy) and then 4 cycles of adjuvant mFOLFIRINOX. The other group undergoes upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX chemotherapy. The chemotherapy drugs used include leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, all administered intravenously. During the study, participants will be closely monitored for overall survival up to 5 years after randomization. Assessments include eligibility screening, surgery, chemotherapy cycles, and follow-up visits to track health status and treatment effects. The trial focuses on determining if the timing of mFOLFIRINOX around surgery affects patient survival and safety over the long term.

This research aims to assess the impact of implementing a set of antibiotic stewardship strategies in Dutch hospitals for newborns suspected of early-onset sepsis (EOS). The study focuses on introducing three proven methods: the EOS calculator, procalcitonin (PCT)-guided therapy, and intravenous-to-oral switch therapy. These approaches have demonstrated safety and effectiveness and are already in use in some hospitals, but not all, leading to varied clinical practices. The goal is to actively implement these strategies to improve treatment consistency and outcomes. The study uses a prospective, multicenter, non-randomized pre-post design to evaluate the effects of introducing these antibiotic stewardship interventions. The implementation includes a combination of methods to support adoption across hospitals. The study compares data from 12 months before and 12 months after the new strategies are put into practice, focusing on clinical and implementation results. Participants' clinical information will be collected retrospectively and anonymized by hospital data units before being shared with the research team. Additionally, qualitative data will be gathered using focus groups, interviews, and surveys to understand the experiences and challenges related to the implementation. The main outcome being measured is the number of days newborns receive therapy during the specified periods.

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 whether adding 18F-Fluorodeoxyglucose Positron Emission Tomography/Computerized Tomography (18F FDG PET/CT) scans during follow-up improves the 3-year overall survival of patients with stage III non-small cell lung cancer (NSCLC) compared to conventional CT scan surveillance. This study focuses on early detection of tumor recurrence to potentially allow curative treatments and improve survival and quality of life. It also examines secondary outcomes such as recurrence detection rates, event-free survival, cost-effectiveness, and patient experiences with additional PET/CT scans. Participants are divided into two groups: the control group receives usual care with conventional CT scans of the thoracic region at 6, 12, 18, 24, and 36 months after treatment. The intervention group receives these same CT scans plus additional whole-body 18F FDG PET/CT scans at the same follow-up visits. All participants may also receive adjuvant treatments during follow-up. Optional activities include completing quality of life questionnaires at each time point, participating in interviews about the PET/CT scans, and giving blood samples for research purposes. During the study, participants will be monitored with scheduled imaging visits at 6-month intervals up to 3 years post-treatment. Researchers will assess overall survival, detect both symptomatic and asymptomatic recurrences, evaluate quality of life, and analyze cost-effectiveness. The study includes intention-to-treat and per-protocol analyses, with survival compared using Kaplan-Meier curves. Optional interviews and blood collections provide additional data on patient experience and recurrence detection. Participants provide informed consent and their progress is carefully followed to understand the impact of additional PET/CT surveillance.