Tiel

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 evaluating the effects and safety of different doses of AP31969, an oral medication, compared to a placebo for controlling the rhythm of atrial fibrillation (AF). This randomized Phase 2 clinical trial focuses on adults diagnosed with paroxysmal or persistent AF, aiming to reduce AF burden — the percentage of time a person has AF — over the course of the study. Participants will be randomly assigned to receive AP31969 in doses of 100 mg, 200 mg, 350 mg, or later 500 mg, or a placebo. All treatments are taken orally twice daily. The study consists of three main periods: a screening phase lasting up to 4 weeks, a 12-week treatment phase, and a 30-day follow-up. During the trial, participants will have a loop recorder implanted to continuously monitor heart rhythm. Throughout the study, participants will attend scheduled visits for assessments including blood and urine tests and electrocardiograms to monitor heart activity. The primary measurement is the burden of atrial fibrillation from week 2 to week 12. The total participation time is about 20 weeks, during which safety and effectiveness of AP31969 will be closely observed.

Researchers are evaluating the (cost)effectiveness of the Occupational Therapy at Home E-Rehabilitation (OTHER) intervention compared to usual occupational therapy care in older adults recovering from stroke. The study focuses on community-dwelling persons aged 60 and older in geriatric rehabilitation, aiming to improve self-perceived performance in daily activities, satisfaction with performance, physical activity, and self-management over 26 weeks. It also explores participant and therapist experiences with the intervention and investigates factors affecting its delivery and benefits. The OTHER intervention involves occupational therapists using activity monitoring, coaching, and videoconferencing to support the transition from clinical care to home. Participants receive this treatment over a 24-week period, with assessments at weeks 4, 13, and 26. The study compares this approach to standard occupational therapy to determine differences in outcomes such as daily functioning and quality-adjusted life years. Participants will be involved in regular evaluations including the Canadian Occupational Performance measure at three time points to track changes in daily activity performance. Researchers will monitor treatment fidelity, barriers, facilitators, and cost-effectiveness. The study includes qualitative assessments to understand experiences of stroke survivors and therapists and their reflections on the intervention. Total participation lasts for about 26 weeks with ongoing monitoring.

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.

Acute coronary syndrome (ACS) is a leading cause of death worldwide. Researchers aim to improve cardiovascular care by creating a detailed, ongoing registry of patients with ACS to study the long-term effects of diagnostics, treatments, and devices used in everyday clinical practice. This approach addresses limitations of randomized controlled trials (RCTs) by capturing real-world patient data and outcomes for better evaluation and quality improvement, especially in the Dutch healthcare system. The study collects clinical and possibly genetic information from patients presenting with ACS in a prospective manner. It uses electronic patient records to gather data uniformly, allowing researchers to assess medication, devices, diagnostic tools, and follow-up care. The registry supports evaluating risk scores, comparing treatments, and enhancing adherence to guidelines to improve patient outcomes and secondary prevention. Participants are followed over time with regular data collection on mortality, recurrent ischemic events, hospital admissions, and quality of life. The study evaluates health-care pathways, treatment effectiveness, and safety in routine practice compared to clinical trials. The registry's ongoing nature helps monitor long-term impacts and supports personalized medicine efforts, focusing on improving care coordination between cardiologists and general practitioners.

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 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.