Haarlem

Researchers are investigating new treatments for children with different types of advanced, relapsed, or refractory melanoma, solid tumors, and lymphomas that cannot be cured by surgery or have not responded well to previous therapies. This study focuses on evaluating pembrolizumab, an immunotherapy drug that helps the immune system fight cancer. The study is a Phase I/II trial that includes children from 6 months to under 18 years old, but some enrollment groups have closed based on recent amendments. Participants will receive pembrolizumab through an intravenous infusion. The study includes multiple groups based on cancer type, including melanoma, classical Hodgkin lymphoma, and solid tumors with specific genetic markers. The treatment aims to assess different doses of pembrolizumab to see if it can shrink or eliminate tumors. Enrollment for some groups, such as children under 12 with melanoma and certain tumor types, has been closed as the trial progresses. During the study, participants will be evaluated for tumor response using established criteria and monitored for side effects and toxicities for up to two years. Researchers will collect tissue samples and conduct regular assessments including scans, laboratory tests, and physical exams. The study tracks safety, treatment discontinuations due to adverse events, and overall response rates to understand the drug’s effects in these pediatric cancers.

This research aims to evaluate whether the ADHD&me (ADHD&ik) intervention can improve self-esteem in young people aged 16 to 25 years who have Attention Deficit Hyperactivity Disorder (ADHD) and low self-esteem. ADHD is a condition characterized by difficulties with attention, impulsivity, and hyperactivity, often continuing into adulthood and affecting education, work, and social life. The study also explores whether improving self-esteem can help reduce related issues like anxiety, depression, stress, and the masking of ADHD behaviors. This trial uses a randomized controlled design to compare immediate treatment with a waitlist control group. The ADHD&me intervention consists of seven individual cognitive behavioral therapy (CBT) sessions lasting 45-60 minutes each, led by trained therapists. These sessions focus on helping participants recognize and change negative self-beliefs and masking behaviors, build positive self-images using personal strengths, and improve how they interact with their environment. Participants in the waitlist group receive the same intervention after an eight-week delay. The program includes structured exercises, goal setting, and practice assignments between sessions to support lasting changes. Participants will complete questionnaires about self-esteem and mental health symptoms at the start, after the intervention or waitlist period, and two months later to measure lasting effects. They will also complete short daily assessments during one week at the beginning and one week after treatment to track momentary feelings and activities. Researchers will monitor treatment quality, participant satisfaction, and changes in ADHD symptoms, stress, and quality of life throughout the study.

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.

The BioDay Registry collects real-world data on the safety and effectiveness of new systemic treatments such as biologics and Janus kinase inhibitors in patients with atopic dermatitis. It also investigates how these treatments affect other related allergic conditions like food allergies, asthma, and conjunctivitis. This multicenter registry aims to provide valuable information for daily clinical practice. The registry includes several modules focused on different atopic comorbidities to capture comprehensive patient data during biologic treatment. It observes patients treated with new systemic therapies over time in a real-world setting without assigning specific interventions. Participants provide information through questionnaires and regular assessments to track treatment effects and side effects. Researchers monitor changes from baseline at several time points, including 16 weeks, 1 year, and 2 years, and analyze how long patients continue their prescribed treatments. The study includes both adults and children and follows them prospectively to gather long-term safety and effectiveness data.

Researchers are evaluating two types of cognitive-behavioral therapy (CBT) for adults aged 18 and older with anxiety-related disorders, including panic disorder, agoraphobia, generalized anxiety disorder, social anxiety disorder, posttraumatic stress disorder, obsessive-compulsive disorder, and health anxiety disorder. The study aims to determine whether brief-intensive CBT leads to faster and better improvement in daily functioning such as work and family life compared to regular weekly CBT. This is a parallel-group randomized controlled trial conducted in multiple centers. Participants will receive either brief-intensive CBT, consisting of 16 exposure therapy sessions delivered over 4 half-days within 2 weeks plus 4 follow-up sessions within 3 months, or regular CBT consisting of 20 weekly sessions over 6 months. Both treatment approaches include 20 sessions of 45 minutes each and can be personalized to focus on improving work or family functioning. This trial compares the effects and feasibility of these two treatment schedules. During the 1-year study, participants will complete seven assessments lasting about 5 hours total, including online questionnaires and telephone interviews. These will evaluate health, disability, quality of life, anxiety and depression symptoms, coping strategies, and therapy expectations. The main outcome is the change in health and disability over 6 months. Additional measures include treatment effectiveness after 1 year, cost-effectiveness, and participants' preferences and drop-out rates.

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.

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 treatments for infrarenal abdominal aortic aneurysms (AAA) with wide proximal aortic neck diameters between 28mm and 32mm. The goal is to compare clinical outcomes between standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system and endosuture aneurysm repair (ESAR) which combines the Endurant II/IIs stent graft with the Heli-FX EndoAnchor system. This prospective, randomized controlled trial involves up to 300 subjects across about 40 sites in Europe and the US, focusing on gathering clinical evidence specific to this patient population where current comparative data are lacking. Participants will be randomly assigned in a 1:1 ratio to receive either EVAR alone or EVAR combined with the EndoAnchor system (ESAR). Treatments will follow the instructions for use of the Endurant II/IIs and Heli-FX EndoAnchor devices. Follow-up assessments will occur at baseline, the time of the procedure, 1 month, and then annually for up to 5 years. The trial aims to assess the superiority of ESAR over EVAR in terms of clinical outcomes related to the wide proximal neck anatomy. During the study, participants will undergo clinical evaluations and CT imaging according to local guidelines and device recommendations. Researchers will monitor treatment success, focusing on proximal seal outcomes over a one-year period as the primary measure. Safety and long-term effectiveness will also be tracked through yearly follow-ups for up to five years, providing comprehensive data on the performance of these treatments in managing infrarenal AAA with wide proximal necks.

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 evaluating whether an intensive trauma-focused treatment program can effectively reduce symptoms of post-traumatic stress disorder (PTSD) in adults receiving their first treatment, while also assessing the societal costs compared to standard weekly treatment. This randomized controlled trial focuses on adults diagnosed with PTSD from multiple traumatic events who have had little or no prior treatment for PTSD. The study aims to determine if the intensive program can improve PTSD symptoms and be more cost-effective than typical weekly therapy. Participants are assigned to either an intensive treatment group or a standard weekly treatment group. The intensive treatment includes two weekly preparatory sessions, followed by five days of twice-daily therapy sessions consisting of prolonged exposure (PE) and eye movement desensitization and reprocessing (EMDR), and ends with two closing sessions focused on integration and prevention planning. This total treatment lasts six weeks and involves 800 minutes of therapy. The standard treatment group receives 800 minutes of weekly therapy over 13 to 16 weeks, using evidence-based methods such as PE, EMDR, brief eclectic psychotherapy, narrative exposure therapy, or imaginary rescripting. During the study, participants complete questionnaires and interviews at five different times over nine months: at baseline, after intensive treatment (7 weeks), after weekly treatment (17 weeks), and at 6 and 9 months follow-up. Researchers will monitor treatment adherence, symptom changes using the Clinician Administered PTSD Scale, and cost-effectiveness through quality of life and cost inventories. Continuous monitoring ensures safety and data collection throughout the study period.