Den Haag

This research aims to evaluate whether creating dedicated HIV teams in hospitals across ten European countries can increase HIV testing rates among patients showing signs of HIV-related conditions. The study uses a stepped-wedge design, where hospitals switch from routine care to the new intervention in sequence. This approach compares outcomes before and after the teams are in place, helping to understand the impact of the intervention across various locations and medical specialties. The intervention involves establishing local HIV teams led by specialists and supported by nurses and data experts. These teams identify patients needing HIV tests through electronic health records, provide feedback to doctors to encourage testing, offer education to healthcare staff about HIV, reduce stigma, and improve connections to prevention and care services. This program integrates smoothly into regular hospital routines and aims to close gaps in HIV diagnosis. Participants HIV testing rates will be monitored by reviewing records before and after the intervention. Researchers will also assess new HIV diagnoses, changes in testing patterns by country and specialty, and healthcare professionals knowledge and attitudes toward HIV. The study includes ongoing evaluation of how well the teams operate, resource use, and cost-effectiveness. Data collection extends up to several years to observe long-term effects, with continuous monitoring of care access and prevention services.

Researchers are evaluating new treatments for advanced renal cell carcinoma RCC, a type of kidney cancer. This study compares the effects of combining two targeted therapies, belzutifan and zanzalintinib, against belzutifan with a placebo. The goal is to see if the combination can help people live longer and prevent the cancer from getting worse after other treatments have failed. Participants will take 120 mg of belzutifan orally and either 60 mg of zanzalintinib or a matching placebo once daily for about 24 months. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active combination or placebo. Two groups are compared belzutifan plus zanzalintinib and belzutifan plus placebo. During the study, participants will be monitored for progression-free survival and overall survival, with assessments up to around 30 to 50 months. Researchers will also evaluate tumor response, duration of response, quality of life, and side effects. Safety and tolerability will be tracked throughout treatment and follow-up periods. The study is sponsored by Merck Sharp & Dohme LLC and aims to provide important information on treating advanced RCC.

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Primary immune thrombocytopenia ITP is a condition where the immune system mistakenly destroys platelets, leading to a lower number of platelets and increased risk of bruising or bleeding. This Phase 3 study evaluates the long-term safety, tolerability, and effectiveness of mezagitamab in adults with chronic primary ITP. The study also investigates how the body processes mezagitamab over an extended period. Participants who completed previous mezagitamab studies TAK-079-3002 or TAK-079-1004 will be invited to join this continuation trial. Eligible participants may receive mezagitamab injections on demand, with treatment courses repeated as needed based on specific criteria and the investigators clinical judgment. The treatment is administered subcutaneously. During the study, participants will visit the clinic several times for assessments. Researchers will monitor safety by tracking treatment-emergent adverse events, and evaluate effectiveness through platelet response and remission rates. Measurements of drug levels and antibodies will also be taken. The study may last up to approximately 108 weeks, allowing detailed long-term follow-up.

Researchers are evaluating the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

Researchers are evaluating how well JNJ-79635322 works compared with an anti-B-cell maturation antigen BCMAxCD3 bispecific antibody in adults with relapsed or refractory multiple myeloma. This phase 3 study includes participants who have received at least three prior therapies and have progressive disease or insufficient response to their last treatment. The study aims to assess treatment outcomes including overall response and progression-free survival over a period of up to 5 years and 7 months. Participants are randomly assigned to receive either JNJ-79635322 or teclistamab, both given as subcutaneous injections. Treatment continues until disease progression or intolerable side effects occur. These two groups allow comparison of the effects of each drug on disease control and patient well-being during the study. During the study, participants undergo regular assessments to monitor their response to treatment, including laboratory tests to measure disease markers and evaluations of symptoms, functioning, and quality of life. Researchers will track adverse events, immune responses to the drugs, and long-term outcomes such as duration of response and overall survival. The total participation time can extend up to nearly 6 years, with ongoing monitoring of symptoms and quality of life throughout this period.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Primary immune thrombocytopenia ITP is a condition where the immune system mistakenly destroys platelets, the cells responsible for blood clotting, resulting in increased bleeding and bruising. This trial evaluates whether mezagitamab given as a subcutaneous injection can effectively maintain stable platelet counts in adults with chronic ITP compared to a placebo. The study is a phase 3, randomized, double-blind, placebo-controlled trial designed to assess both the efficacy and safety of mezagitamab in this population. Participants are randomly assigned to receive either mezagitamab or a matching placebo by subcutaneous injection once weekly. The treatment schedule consists of 8 weekly doses followed by an 8-week break, then another 8 weekly doses, totaling up to 6 months of treatment. Those who finish this trial or do not respond to treatment by week 16 may have the option to join a continuation study to receive open-label mezagitamab if eligible and if the site is open. During the study, participants will visit the clinic multiple times for treatment and monitoring. Researchers will measure platelet responses, symptom changes using patient questionnaires, bleeding events, and blood concentrations of mezagitamab. Safety assessments include monitoring for anti-drug antibodies and adverse events. The primary outcome is the percentage of participants with a durable platelet response up to week 24. The trial is expected to complete in March 2028.

Researchers are evaluating the safety and effectiveness of atogepant, a medicine approved for preventing migraine in adults, in young participants aged 12 to 17 years who experience chronic migraine. The study aims to compare atogepant with a placebo, which looks like the medicine but contains no active drug. It focuses on monitoring side effects and changes in migraine frequency in this pediatric population. Participants will be randomly assigned to receive either atogepant or placebo tablets once daily for 12 weeks in a double-blind design, meaning neither participants nor doctors know who receives which treatment. After the treatment period, participants will be followed for an additional 4 weeks to observe ongoing effects. The study plans to enroll about 420 adolescents across approximately 70 sites worldwide. During the study, participants will attend regular clinic visits where researchers will assess treatment effects through daily diaries, medical exams, blood tests, side effect monitoring, and questionnaires. The main outcomes include the number of participants experiencing adverse events and changes in the average monthly number of migraine days. Secondary measures cover headache days, medication use, quality of life, and migraine-related disability. Total participation lasts about 16 weeks.

The trial investigates the use of left ventricular LV unloading via intra-aortic balloon pumping IABP to improve weaning success from venoarterial extracorporeal membrane oxygenation VA ECMO in patients with cardiogenic shock. The study is part of the REMAP ECMO platform, which embeds multiple response adaptive randomized trials within a patient registry. This research aims to fill knowledge gaps about managing ECMO and related therapies, as current practices rely mostly on observational data and expert opinion. Patients are randomized to receive either VA ECMO support with LV unloading through IABP or VA ECMO alone without an unloading device. The IABP must be placed within 8 hours of ECMO initiation for those in the unloading arm. The study also includes a nested physiological substudy assessing the effects of IABP on respiratory and hemodynamic parameters, including microcirculation, macrocirculation, and the impact of positive end-expiratory pressure PEEP as an unloading method during decremental PEEP trials. Participants undergo a range of assessments including evaluation of ECMO weaning success at 30 days, mortality rates at 30 days, 90 days, and 1 year, and various clinical parameters during ECMO support such as bleeding events, mechanical ventilation duration, heart function, and quality of life at one year. The physiological substudy collects detailed measurements like heart rate, pulmonary artery catheter data, echocardiography, microcirculation, respiratory parameters, and biomarkers at 24 and 48 hours after ECMO initiation. The study involves long-term follow-up up to one year and tracks health care costs and hospital readmissions.