Haarlem

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

This research aims to evaluate whether the ADHD&me ADHD&ik intervention can improve self-esteem in youth aged 16 to 25 years with Attention Deficit Hyperactivity Disorder ADHD. ADHD is a neurodevelopmental disorder characterized by attention, impulsivity, and hyperactivity challenges, which often persist into adulthood and can impact many life areas. The study also investigates if the intervention affects related issues like masking ADHD behaviors and mental health symptoms such as anxiety, depression, and stress. The ADHD&me intervention is a cognitive behavioral therapy CBT-based program consisting of seven weekly individual sessions lasting 45 to 60 minutes each. Participants are randomly assigned to either an immediate treatment group or a waitlist control group that receives the intervention after an eight-week delay. The therapy includes exercises, goal setting, and homework assignments designed to improve self-esteem by addressing negative self-beliefs and coping behaviors related to ADHD. Participants complete questionnaires on self-esteem, ADHD symptoms, and mental health at baseline, post-treatment, and two-month follow-up. They also complete short daily assessments during one week at the start and after the intervention or waitlist period to capture momentary feelings and activities. Researchers monitor therapeutic quality and participant experiences throughout the study, with the primary outcome being self-esteem measured by the Rosenberg Self-Esteem Scale.

This research aims to evaluate whether preventive endovascular stenting of a significant narrowing over 50% in the superior mesenteric artery SMA can reduce the risk of anastomotic leakage AL after elective colon surgery. AL is a serious complication linked to higher mortality, lower quality of life, and increased healthcare costs. A prior study showed that having more than 50% SMA stenosis raises the risk of AL sixfold, and this trial investigates if stenting this artery before surgery can help prevent AL. Participants are randomly assigned to one of two groups the intervention group will receive preventive angioplasty and placement of a covered stent in the SMA before their colon surgery, while the control group will proceed with colon surgery without stenting. Both groups receive daily mono antiplatelet therapy with carbasalate calcium, lifelong for the intervention group and at least 12 months for the control group. The stenting procedure is minimally invasive and performed preferably within two weeks before surgery at specialized centers. Colon surgery is done according to standard local guidelines. Some centers will use intraoperative fluorescence angiography to assess blood flow during surgery. During the 12 months of follow-up after surgery, participants will be monitored for anastomotic leakage within the first 90 days, as well as delayed leakage and surgical complications up to one year. Researchers will collect data on hospital stays, reinterventions, mortality, quality of life, healthcare costs, and stent function. Patient-reported outcomes will be gathered through questionnaires at multiple time points. The study also includes imaging assessments and cost-effectiveness analyses to understand the broader impact of preventive stenting.

Researchers are evaluating a shorter treatment duration with androgen receptor pathway inhibitors ARPIs, specifically Apalutamide or Enzalutamide, in patients with low-volume hormone-sensitive metastatic prostate cancer. This phase 3 clinical trial aims to determine if stopping ARPI therapy after 12 months, with the option to restart if the cancer progresses, is not worse than continuing ARPI treatment. The goal is to reduce side effects and costs while maintaining effective disease control. Participants will be randomly assigned after completing 12 months of ARPI treatment to one of two groups one group will continue androgen deprivation therapy ADT combined with ARPI, while the other will stop ARPI after 12 months but may restart it if a confirmed rise in prostate-specific antigen PSA occurs. The PSA confirmation sample must be taken at least four weeks after the initial rise. Treatment will be monitored closely according to these protocols. During the study, participants will be followed for up to 6 years, including 5 years after randomization to track clinical progression-free survival. Researchers will regularly assess disease status, treatment effects, and possible side effects. The study includes regular visits and monitoring to evaluate how long patients remain free from disease progression while comparing the two treatment approaches.

Researchers are collecting real-world data to evaluate the effectiveness and safety of new systemic treatments such as biologics and Janus kinase inhibitors in patients with atopic dermatitis. The BioDay Registry also studies the impact of these treatments on related allergic conditions like food allergies, asthma, and conjunctivitis. This observational registry gathers information from multiple centers to better understand treatment outcomes in daily clinical practice. Participants include both adults and children receiving new systemic therapies for their atopic dermatitis. There is no assigned treatment in the study since it is observational instead, data is collected as patients receive their prescribed medications. The registry includes modules for atopic comorbidities and monitors patients over time to capture the effects of treatment in routine care. Participants will provide data through questionnaires and clinical assessments at multiple timepoints, including baseline, 16 weeks, 1 year, 2 years, and annually up to 5 years. Researchers track changes in disease symptoms, side effects, drug continuation rates, laboratory results, comorbid conditions, and any dose adjustments. This long-term follow-up aims to improve understanding of treatment safety and effectiveness in everyday settings.

Researchers are studying patients with non-metastatic stage II colon cancer who are part of the Dutch ColoRectal Cancer cohort PLCRC and who consented to additional blood samples. The study aims to evaluate how many patients with detectable circulating tumor DNA ctDNA after surgery begin adjuvant chemotherapy. This observational and interventional trial includes patients who do not have a standard indication for chemotherapy and involves a randomized design to compare ctDNA-guided treatment with standard care. Patients are randomly assigned to one of two groups the ctDNA-based treatment group or the standard care group. In the ctDNA group, blood samples taken after surgery are analyzed for ctDNA. Those with detectable ctDNA are offered 3 months of adjuvant chemotherapy using CAPOX a combination of fluoropyrimidine and oxaliplatin. Patients without detectable ctDNA receive routine follow-up care. The standard care group receives routine follow-up without knowledge of their ctDNA results. Participants will have blood collected before surgery, after surgery, and during follow-up. Researchers will monitor who starts chemotherapy within 8 to 12 weeks after surgery and will track recurrence rates, disease-free survival, overall survival, time to recurrence, quality of life, and cost-effectiveness over several years. Follow-up assessments occur up to 10 years, allowing detailed long-term evaluation of treatment impact and patient outcomes.

This trial evaluates different doses of the drug AP31969 to control the rhythm of atrial fibrillation AF and to determine its safety. The study is a randomized Phase 2 trial comparing AP31969 to a placebo in adults diagnosed with paroxysmal or persistent AF who have a measurable AF burden. The study aims to reduce AF burden and improve quality of life using oral medication. Participants are assigned randomly to receive one of several doses of AP31969 100 mg, 200 mg, 350 mg, or later 500 mg or a placebo. All treatments are given as tablets taken orally twice daily for 12 weeks. The study includes three periods screening up to 4 weeks, treatment 12 weeks, and a follow-up period of 30 days. Participants will have an implantable loop recorder to monitor heart rhythm continuously. During the study, participants will attend scheduled visits where blood and urine tests, electrocardiograms, and other assessments will be performed. Researchers will track AF burden, the number of AF episodes, quality of life changes, and episodes of ventricular tachycardia. The total participation time is about 20 weeks, including all study periods, with safety and treatment effects monitored carefully.

Researchers are evaluating treatments for infrarenal abdominal aortic aneurysm AAA with wide proximal aortic neck diameters 28mm to 32mm. The trial compares clinical outcomes of two methods endosuture aneurysm repair ESAR and standard endovascular aneurysm repair EVAR. This randomized controlled trial aims to provide clinical evidence about the effectiveness of these approaches in patients with this specific aneurysm anatomy, addressing a current lack of comparative data. The study involves two groups one receiving EVAR using the Endurant IIIIs stent graft system alone, and the other receiving ESAR with the Endurant IIIIs stent graft plus the Heli-FX EndoAnchor system. Up to 300 participants will be enrolled across multiple sites in Europe and the US. Participants will be followed according to recommended guidelines and device instructions, with assessments at baseline, the procedure, 1 month, and annually for up to 5 years. During the study, participants will undergo clinical evaluations including CT imaging and other assessments at scheduled visits. Researchers will measure outcomes such as the composite proximal seal success at 1 year, freedom from type IA endoleak, migration, aneurysm sac growth, and neck dilatation. Safety and long-term effectiveness will be monitored through these follow-ups, providing detailed information about the treatments over time.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.

Researchers are investigating whether an intensive treatment program can effectively reduce symptoms of post-traumatic stress disorder PTSD in adults receiving treatment for the first time, while also assessing its societal cost compared to standard weekly treatment. The study focuses on adults diagnosed with PTSD stemming from multiple traumatic events and aims to understand if the intensive approach offers advantages in symptom reduction and cost-effectiveness. Participants will be randomly assigned to one of two groups an intensive treatment group or a standard weekly treatment group. The intensive program includes two preparatory weekly sessions followed by five days of twice-daily sessions over one or two weeks, combining prolonged exposure and eye movement desensitization and reprocessing therapies, with two closing sessions for integration and prevention planning. The standard treatment involves weekly sessions over 13 to 16 weeks using various evidence-based therapies recommended by Dutch guidelines. Both treatments total 800 minutes of therapy, with adherence closely monitored. Throughout the study, participants will complete questionnaires and interviews at five points over nine months to assess PTSD symptoms, quality of life, mental health, treatment satisfaction, and potential harms. Key outcome measures include the Clinician Administered PTSD Scale for DSM-5 and assessments of cost-effectiveness. The study will also evaluate secondary outcomes such as anxiety, depression, moral injury, dissociative symptoms, and cognitive function. The follow-up schedule allows researchers to monitor both immediate and longer-term effects of the treatments.