Leiderdorp

Researchers are investigating the safety, tolerability, and effectiveness of two dosing regimens of itepekimab compared to placebo as an add-on to intranasal corticosteroids in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) that is not well controlled. This multinational Phase 3, randomized, double-blind, placebo-controlled trial involves male and female participants aged 18 years and older living with CRSwNP. Participants are randomly assigned to one of three groups receiving either itepekimab injections or placebo injections, both administered subcutaneously, alongside mometasone furoate nasal spray delivered intranasally. The study includes a 4-week screening period, followed by a 52-week treatment phase, and a 20-week safety follow-up, totaling up to 76 weeks. Participants transitioning to an extension study (LTS18420) will have a total duration of 56 weeks. Study visits include nine site visits and 20 phone or home visits. During the trial, participants will undergo assessments including endoscopic Nasal Polyp Scores (NPS) and Nasal Congestion Scores (NCS) measured from baseline to week 24 to evaluate changes. Researchers will monitor safety and tolerability throughout, with regular evaluations involving symptom severity, treatment adherence, and adverse events. The study aims to understand how well itepekimab works and is tolerated as an additional treatment for CRSwNP over the study duration.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

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 chemotherapy dosing strategies for older patients aged 70 years and above who have metastatic colorectal cancer and are candidates for palliative chemotherapy. This phase III, open-label, randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy to see if the reduced dose is not worse in terms of progression-free survival (PFS). The study also examines secondary outcomes including severe toxicity, quality of life, physical function, overall survival, treatment cycles, dose reductions, hospital admissions, cumulative dosage, and cost-effectiveness. Participants are classified based on their risk of chemotherapy toxicity using the Geriatric 8 (G8) questionnaire. Those at low risk are randomized to receive either full-dose or 25% dose-reduced doublet chemotherapy (a fluoropyrimidine combined with oxaliplatin). Patients at high risk receive either full-dose or dose-reduced monotherapy with a fluoropyrimidine. Targeted treatments like bevacizumab or EGFR inhibitors may be added. Dose adjustments are made for moderate kidney impairment. Treatments are given on schedules involving oral and intravenous chemotherapy drugs administered every 2 to 3 weeks. During the study, participants undergo assessments including clinical evaluations, laboratory tests to monitor blood counts and organ function, and questionnaires for quality of life and physical functioning. Progression-free survival is tracked for at least one year after randomization. Researchers closely monitor treatment toxicity, hospitalizations, dose modifications, and survival. The total planned enrollment is 587 patients, with follow-up for safety and effectiveness throughout the treatment period.

Acute urinary retention (AUR) is a sudden and painful condition where a man cannot urinate, often caused by an enlarged prostate known as benign prostatic hyperplasia (BPH). This condition is typically treated by inserting a catheter to empty the bladder and starting medication that relaxes the prostate. The study evaluates the safety and effectiveness of removing the catheter at different times after insertion, aiming to find the optimal duration before attempting to urinate without the catheter, called a Trial Without Catheter (TWOC). Men in this study will all receive a catheter and begin or continue alpha-blocker medication. Participants are randomly assigned to one of two groups: one will have their catheter removed after three days, and the other after fourteen days. This randomized controlled trial compares these two timelines to see if a shorter catheter duration is as successful as a longer one in allowing normal urination without needing the catheter replaced. During the study, researchers will monitor whether participants need to be re-catheterized either three or fourteen days after catheter removal. They will also assess complications, patient comfort with the catheter, quality of life, and healthcare costs. The results aim to improve care for men with AUR by reducing unnecessary catheterization time, discomfort, and complications, helping doctors decide the best time to remove the catheter.

Researchers are evaluating two methods of delivering spinal cord stimulation (SCS) electrical charge for patients with Persistent Spinal Pain Syndrome Type 2 (PSPS Type 2), also known as Failed Back Surgery Syndrome. This trial compares active recharge burst stimulation with passive recharge burst stimulation to see if there are differences in pain relief and motivational-emotional aspects of pain. This multicenter randomized clinical trial is conducted in six Dutch hospitals and aims to assess which burst stimulation waveform might better affect patient outcomes. Participants will be randomly assigned to receive either active recharge burst or passive recharge burst spinal cord stimulation. After a successful trial period, patients will be permanently implanted with the assigned neurostimulation device. Active recharge burst uses negative pulses to directly compensate for charge differences, while passive recharge burst uses a recharge pattern that passively balances charge differences. The study involves 96 patients and follows them up at multiple time points over a year after implantation. During the study, patients will complete several assessments including the Pain Catastrophizing Scale (primary outcome measured at 6 months), Numeric Pain Rating Scale, Patient Vigilance and Awareness Questionnaire, Hospital Anxiety and Depression Scale, quality of life questionnaires, Oswestry Disability Index, Patient Global Impression of Change, and painDETECT questionnaires. These are completed at baseline, after the trial period, and at 1, 3, 6, and 12 months post-implantation. The study monitors pain experience, emotional and motivational aspects of pain, and overall quality of life throughout the participation period.

Researchers are investigating the treatment of multiple myeloma using a combination of medicines called daratumumab-lenalidomide-dexamethasone (Dara-Rd). This standard treatment in the Netherlands often suppresses the disease for a long time and continues until it stops being effective. The study aims to find out if stopping treatment temporarily, compared to continuing it without breaks, can improve quality of life by reducing side effects and allowing recovery from toxicity, without reducing survival time. The study involves patients who have completed 12 cycles of Dara-Rd treatment and have responded with at least a partial response without biochemical progression. These patients will be randomly assigned to either continue Dara-Rd treatment continuously or take a treatment-free interval. The medications involved include daratumumab injections, lenalidomide capsules, and dexamethasone. Reduced dosing of lenalidomide is allowed but not below 5 mg, and prior dexamethasone dose changes are permitted. The trial is a nationwide, open-label, randomized Phase III study. Participants will be followed for up to approximately 57 months to compare event-free survival and up to 69 months to compare progression-free survival after randomization. Researchers will monitor disease status, side effects, and overall health during this time. Patients must provide informed consent and will undergo regular assessments to evaluate the impact of continuous versus interrupted therapy on their disease and quality of life.

Researchers are evaluating personalized blood thinner treatments after hip or knee replacement surgeries to reduce the risks of blood clots (venous thromboembolism or VTE) and bleeding. Currently, all patients receive the same standard blood thinner treatment, but some still develop blood clots while others experience bleeding. This study aims to see if adjusting the blood thinner dose and duration based on each patient's risk can lower these complications. Participants are divided into three groups based on their predicted risk of blood clots using a scoring system. Patients with low risk receive blood thinners only during their hospital stay. Those with intermediate risk are observed without changes to standard care. Patients with high risk get a higher dose and longer duration of blood thinners for six weeks. The blood thinners used include types such as LMWH or DOACs, given according to local guidelines and timing specified after surgery. Participants complete four questionnaires: one before surgery and three after surgery at 2 weeks, 6 weeks, and 3 months, to report any blood clots or bleeding events. If a participant experiences a clot, major bleed, or infection, an additional questionnaire about quality of life and joint function is sent one year later. No extra hospital visits are required. The main outcomes measured are blood clot and major bleeding events within 90 days after surgery.

Researchers are studying breast cancer patients who have cancer that has spread to lymph nodes and are treated with neoadjuvant systemic therapy (NST), which includes chemotherapy and sometimes immunotherapy. The study focuses on how to best check and treat the lymph nodes after NST, comparing less invasive methods to the traditional axillary lymph node dissection (ALND). The goal is to see if less invasive techniques can offer similar cancer control and quality of life benefits. This multicenter observational study includes patients with positive lymph nodes who receive NST followed by breast and axillary treatment. Data on patient characteristics, tumor details, staging before and after NST, and treatments will be collected into a national database. Patients will complete quality of life questionnaires at diagnosis, and then 1 and 5 years later to understand the impact of different axillary treatment strategies. Participants will be followed for 5 years to evaluate disease-free survival, breast cancer-specific survival, overall survival, and rates of cancer returning in the lymph nodes. Quality of life will be measured using multiple questionnaires over time. The study aims to provide evidence to improve national guidelines and support shared decision-making about axillary treatment options for node positive breast cancer patients.