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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.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

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 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 evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.

Researchers are investigating whether dexrazoxane can prevent anthracycline-induced cardiac dysfunction (AICD) in adult patients with diffuse large B-cell lymphoma (DLBCL) receiving first-line treatment. Patients treated for DLBCL have a higher risk of developing heart damage and heart failure due to anthracycline chemotherapy, with a reported cumulative incidence of 5-10% within five years and even higher rates in elderly patients. The study aims to identify those at highest risk of AICD while ensuring that dexrazoxane does not reduce the effectiveness of cancer treatment. This phase III national trial will enroll 324 patients across 25 Dutch hospitals who are planned to receive six cycles of R-CHOP chemotherapy, including doxorubicin. Participants will be randomly assigned to receive either intravenous dexrazoxane before each doxorubicin infusion or no cardioprotective treatment. Dexrazoxane will be given at a 10:1 ratio to doxorubicin and infused 30 minutes prior to the chemotherapy. Additional drugs given as part of R-CHOP include rituximab, cyclophosphamide, vincristine, and prednisolone. Some patients with double hit lymphoma may also receive lenalidomide. Supportive treatment with pegfilgrastim will be provided if needed. Participants will have their heart function assessed by echocardiography before starting chemotherapy and at 4 and 12 months after randomization. The main outcome is the incidence of AICD, defined by a significant decline in heart pumping ability. Researchers will also measure complete metabolic remission to confirm that dexrazoxane does not interfere with cancer treatment. The study includes detailed monitoring of patient and treatment factors to better predict AICD risk. Total participation lasts at least 12 months post-treatment initiation.

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 the safety and effectiveness of a reduced dose of thrombolytic therapy combined with low-molecular-weight heparin in patients who have intermediate-high-risk acute pulmonary embolism. This Phase 3, randomized, placebo-controlled, double-blind, multinational trial aims to determine whether the lower dose of thrombolytic treatment can reduce risks while minimizing serious bleeding events compared to standard care. The study focuses on patients diagnosed within 24 hours who have a higher risk of death or hemodynamic collapse. Participants will be randomly assigned to receive either alteplase or a placebo. The treatment involves a single intravenous infusion given over 15 minutes at a dose of 0.6 mg per kilogram of body weight, not exceeding 50 mg. All patients will also receive parenteral anticoagulation with low molecular weight heparin, unfractionated heparin, or fondaparinux. The infusion is administered within 30 minutes of randomization, which occurs within 6 hours after confirming diagnosis and risk criteria. During the study, participants will be monitored for 30 days to assess outcomes including death, hemodynamic decompensation, and recurrent pulmonary embolism. Additional evaluations will include safety, clinical benefits, mortality rates at 30 days, and longer-term effects on functional impairment, heart function, and chronic pulmonary hypertension at 6 months and 2 years. The study will also track healthcare resource use over 30 and 180 days. Safety assessments, informed consent, and regular follow-up are part of the participant involvement throughout the study period.