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Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating the safety and performance of the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR in patients with coronary artery disease (CAD). This prospective, observational registry includes patients who have undergone percutaneous coronary intervention (PCI) using this stent and are planned for a short dual antiplatelet therapy (DAPT) regimen lasting up to 3 months. The aim is to assess clinical outcomes in a real-world population across multiple countries and centers. Participants receive the Vivo ISAR stent and follow standard care with a short DAPT treatment of no more than 3 months after PCI. The study does not influence the choice of device or treatment beyond routine care. After the procedure, patients who meet eligibility criteria and provide consent are enrolled and observed over time without additional interventions. Participants will be followed up through routine clinical practice and telephone calls at 30 days, 3 months, and 12 months after PCI. These follow-ups collect information on ongoing medications, any lab tests performed, adverse events, and any further interventions. The main outcomes measured at 12 months include ischemic events and bleeding events related to the treatment and stent use.

Physical restraints are still frequently used in about 20-25% of adult ICU patients in the Netherlands who are agitated or expected to become agitated, despite their harmful short- and long-term effects. This research evaluates the effectiveness of a person-centered multicomponent intervention (MCI) program that combines non-drug approaches with goal-directed light sedation using dexmedetomidine. The study compares this new approach with the traditional standard care that includes physical restraints, aiming to improve patient safety and outcomes during ICU stays. The intervention group will receive the MCI program, which involves non-pharmacological strategies and light sedation with dexmedetomidine as needed to manage agitation. This is compared against the current standard care involving physical restraints. The study focuses on adult ICU patients expected to stay longer than 24 hours and who show or are expected to show agitation within the first 14 days of ICU admission. The trial monitors short- and long-term outcomes as well as healthcare costs. Participants' involvement includes monitoring ICU-free days over 28 days as a primary outcome. Researchers will assess agitation levels, sedation needs, and the use of physical restraints. Safety and long-term effects will be tracked, with consent required for extended follow-up in related studies. The study excludes patients with certain neurological conditions, substance intoxication, or other risks, and requires participants or their relatives to understand Dutch for follow-up communication.

Researchers are investigating how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure with reduced or mildly reduced ejection fraction and left ventricular hypertrophy. This Phase 2 study compares CDR132L to a placebo, where participants receive either treatment randomly. The study aims to evaluate changes in a specific biomarker, microRNA-132-3p, over 24 weeks, with the total study duration lasting about 60 weeks. Participants will receive either CDR132L or a placebo through an intravenous infusion once every 4 weeks for a total of 48 weeks. The treatments are given under a double-blind design, meaning neither the participants nor the researchers know who receives which treatment until the study ends. This allows for a fair comparison of the effects of CDR132L versus placebo on heart structure and function. During the study, participants will undergo regular assessments including laboratory tests to measure heart-related biomarkers and imaging tests such as echocardiography to monitor heart structure and function. Researchers will track changes from baseline to week 24 in microRNA-132 levels and continue monitoring participants through the 60-week study period to evaluate safety and treatment effects. Ongoing clinical evaluations and safety checks will help ensure participant well-being throughout the trial.

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 evaluating whether tucatinib combined with trastuzumab and mFOLFOX6 works better than the standard treatments for people with HER2 positive metastatic colorectal cancer, which is cancer that has spread or cannot be removed by surgery. This phase 3 study also aims to identify the side effects that may occur with this drug combination. Participants must have HER2 positive disease confirmed by testing and measurable cancer according to specific criteria. Participants will be randomly assigned to one of two groups. One group will receive tucatinib taken orally twice daily along with intravenous trastuzumab and the mFOLFOX6 chemotherapy regimen, which includes oxaliplatin, leucovorin or levoleucovorin, and fluorouracil given by IV every two weeks. The other group will receive standard care, which could be mFOLFOX6 alone or combined with either bevacizumab or cetuximab, both given by IV on specific schedules. Treatment continues as per the study protocol. During the study, participants will be monitored for progression-free survival up to about three years using imaging reviewed by independent experts. Researchers will assess side effects and disease response. Participants must be able to provide tumor tissue samples for testing and have a good performance status. The study includes brain imaging to check for metastases and monitors safety closely throughout the treatment period.

Researchers are evaluating the use of Autologous Fat Transfer (AFT) with pre-expansion as a full breast reconstruction method for female breast cancer patients who have undergone or will undergo mastectomy. This multicenter prospective cohort study aims to monitor the quality of life, aesthetic outcomes, complications, oncological safety, and cost-effectiveness of AFT. The study builds on the previous BREAST trial that compared AFT with implant-based reconstruction, but here all patients receive AFT. Participants in this study will undergo full breast reconstruction using AFT combined with an external expansion device. This procedure is offered to women who have had or are candidates for mastectomy, including those undergoing preventive mastectomy. The external expansion device must be worn by participants to assist the reconstruction process. There is no comparator group in this study as all patients receive the AFT treatment. During the study, participants will be followed for at least two years to evaluate breast-related quality of life and other outcomes. Researchers will monitor safety, aesthetic results, and complications throughout this period. Patients will be assessed regularly to track their progress and any adverse effects related to the treatment, with particular attention to oncological safety and overall well-being after reconstruction.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

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.

Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design). Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.