Delft

Researchers are evaluating pasritamig JNJ-78278343 combined with best supportive care BSC compared to placebo with BSC in men with metastatic castration-resistant prostate cancer mCRPC, a form of prostate cancer that has spread and no longer responds to hormone therapies. This Phase 3 randomized, double-blind study aims to assess overall survival, measuring how long participants live from the start of the study until death from any cause. Participants will be randomly assigned to receive either pasritamig or placebo through intravenous infusion. The dosing starts with step-up doses on Cycle 1 Day 1 and Day 8, followed by a target dose on Day 15. Subsequent cycles of treatment occur every 6 weeks, with Cycle 1 lasting 8 weeks and later cycles lasting 6 weeks each. All participants may also receive best supportive care, which includes treatments like radiation, steroids, pain medication, and other palliative procedures, at the physicians discretion. Treatment continues until disease progression, intolerable side effects, withdrawal, death, or end of study. During the study, participants will have regular assessments to monitor overall survival and other outcomes such as progression-free survival, symptomatic progression, skeletal-related events, and time to pain or fatigue worsening. Laboratory tests and monitoring for adverse events will occur up to 2 years and 8 months. Participants will receive ongoing evaluation to track treatment effects and safety throughout the trial duration, which spans until August 2028.

This trial studies newly diagnosed multiple myeloma in participants who are not candidates for stem cell transplant. It compares the effects of two drug combinations teclistamab with daratumumab and lenalidomide Tec-DR, and talquetamab with daratumumab and lenalidomide Tal-DR, against the standard treatment of daratumumab, lenalidomide, and dexamethasone DRd. The goal is to assess how these combinations affect disease progression and treatment response. Participants are randomly assigned to one of three groups receiving either Tec-DR, Tal-DR, or DRd. Teclistamab and talquetamab are given as subcutaneous injections, daratumumab is given subcutaneously, lenalidomide is taken orally, and dexamethasone can be given orally or intravenously. Treatments are administered according to the study protocol over an extended period, with follow-up lasting up to nine years to monitor outcomes. During the study, participants undergo regular evaluations including disease progression monitoring, minimal residual disease status at 12 months, and assessments of response levels. Researchers also track survival, adverse events, laboratory and vital sign changes, quality of life, and drug concentrations. The study involves multiple visits for treatment and assessment to carefully evaluate the long-term impact of these drug combinations on patient health and disease control.

Researchers are evaluating the effect of PKN605, an oral medication, on atrial fibrillation, a condition affecting heart rhythm. This Phase 2 study is designed as a randomized, double-blind, placebo-controlled trial to assess how well PKN605 reduces the time participants spend in atrial fibrillation, as well as its safety, tolerability, and how the body processes the drug. The study is sponsored by Novartis Pharmaceuticals and aims to provide detailed information about the treatments impact on this heart condition. Participants will first undergo a screening period of up to 90 days to confirm eligibility. Those who qualify will be randomly assigned to receive one of two doses of PKN605 or a matching placebo. The treatment phase lasts 24 weeks, during which participants take the oral study drug and attend clinic visits about once a month. Their heart rhythm will be monitored using ECG devices throughout the study. After completing treatment, participants will have a final safety follow-up visit approximately one month later. During the study, participants will have regular ECG monitoring to measure atrial fibrillation burden and check for recurrence. Additional assessments include pharmacokinetic sampling to measure drug concentration at specific times after dosing. Researchers will evaluate the primary outcome of atrial fibrillation burden over 24 weeks and secondary outcomes related to recurrence and drug levels. Safety and tolerability are closely monitored, and participants usual heart care continues alongside study participation.

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.

This trial investigates treatment options for adults aged 16 to 69 with early-stage classical Hodgkin lymphoma, specifically stage I or II supradiaphragmatic disease without mediastinal bulk or B symptoms. The study compares two chemotherapy regimens ABVD and A2VD, using a PET response-adapted design to adjust therapy based on treatment response. It is a phase III, randomized, open-label trial conducted internationally and sponsored by University College London and Canadian Cancer Trials Group. Participants will be randomly assigned to receive either ABVD chemotherapy doxorubicin, bleomycin, vinblastine, and dacarbazine or A2VD chemotherapy doxorubicin, brentuximab vedotin, vinblastine, and dacarbazine with growth factor support. After two 28-day cycles, a PET-CT scan will assess response using the Deauville score to guide further treatment. Patients with scores 1-3 receive one more cycle those with score 4 receive two more cycles followed by involved site radiotherapy patients with score 5 discontinue trial treatment and receive alternative therapy as determined by their clinician. Throughout the study, participants undergo PET-CT scans and clinical assessments to monitor treatment response and safety. They will be followed for at least five years post-treatment to evaluate progression-free survival and other outcomes such as event-free survival, overall survival, and incidence of second cancers or cardiovascular disease. Safety and toxicity are monitored from treatment start until 30 days after completion. The overall study period extends until 2032.

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.

Researchers are studying whether adjuvant chemotherapy can prevent disease recurrence in adults with high-risk rectal cancer who have detectable circulating tumor DNA ctDNA after surgery. The study aims to determine if this chemotherapy improves disease-free survival compared to standard care. Rectal cancer remains a significant cause of mortality, and while current treatments reduce local recurrence, distant recurrence rates stay high. Identifying patients with residual disease through ctDNA may help target those who might benefit from additional chemotherapy. Participants with detectable ctDNA after surgery will be randomly assigned to receive either standard care or adjuvant chemotherapy consisting of 6 cycles of FOLFOX 5FUfolinic acid and oxaliplatin every 2 weeks or 4 cycles of CAPOX capecitabine and oxaliplatin within 8 to 12 weeks after surgery. The chemotherapy treatment lasts about 3 months. The study is conducted within a prospective colorectal cancer cohort using a randomized controlled design. During the study, participants will have blood samples taken and visits with their physicians before each chemotherapy cycle if assigned to treatment. Researchers will monitor disease-free survival, overall survival, and quality of life using questionnaires over several years. They will also assess the clearance of ctDNA after chemotherapy and study its presence at recurrence. The total follow-up includes up to 2 years for disease recurrence and up to 5 years for survival outcomes.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating the feasibility and safety of a ventilation strategy called permissive lung-protective ventilation in adult critically ill patients who require invasive mechanical ventilation due to acute hypoxemic respiratory failure. This pilot trial aims to inform the design of a future larger randomized clinical trial by comparing permissive lung-protective ventilation with conventional lung-protective ventilation. The study focuses on how lowering the respiratory rate may reduce ventilation intensity while managing carbon dioxide levels safely. Participants are randomly assigned to one of two groups one group receives permissive lung-protective ventilation where the respiratory rate is gradually reduced based on blood gas analysis and continuous monitoring, allowing mild increases in carbon dioxide levels within safe limits. The other group receives conventional lung-protective ventilation with standard respiratory rates targeting normal carbon dioxide and pH levels. Blood gas analyses are performed frequently to monitor patient status until ventilator weaning or extubation. Throughout the study, participants undergo regular assessments including arterial blood gas tests, continuous end-tidal CO2 monitoring, and data collection on ventilation parameters and outcomes. Researchers measure the feasibility of reducing respiratory rate, adherence to the protocol, safety indicators such as hypercapnia and hypoxemia, and ventilator-associated complications. Data collection continues up to 90 days for follow-up, with the primary evaluation lasting from ventilation start until first extubation, up to 28 days.

The trial investigates chronic pelvic pain caused by endometriosis, a chronic inflammatory condition affecting about 10% of women of reproductive age. This disease often leads to severe pain, reduced quality of life, depression, and economic impact. The study aims to assess how esketamine, a drug with pain-relieving, anti-inflammatory, and antidepressant properties, compares to placebo in treating this chronic pain through a randomized controlled design. Participants will receive either an esketamine infusion or a placebo saline infusion. The esketamine dosing begins at 0.1 mgkgh and may be increased gradually every few hours over an 8-hour period up to a maximum of 0.5 mgkgh based on monitored vital signs and side effects. The placebo group will receive an 8-hour saline infusion. This treatment phase is followed by scheduled assessments to evaluate the effects. Participants will be monitored for pain levels, side effects, quality of life, depressive symptoms, and pain coping ability before and after treatment. Assessments occur at baseline and at multiple time points up to 12 weeks after infusion, including evaluations of pelvic pain, menstrual pain, urinary and bowel pain, depressive symptoms, and overall quality of life. Safety and treatment experiences are also recorded during and immediately after infusion. The total study duration includes follow-up visits to track ongoing effects and costs related to productivity and medical care.