Heerlen

Researchers are evaluating tulisokibart as a potential treatment for radiographic axial spondyloarthritis (r-axSpA), a type of arthritis causing pain, stiffness, and inflammation in the spine and pelvis joints, visible on X-rays. This Phase 2b study aims to determine if different doses of tulisokibart improve symptoms better than a placebo, which looks like the study medicine but contains no active drug. The study has two main parts: a 16-week placebo-controlled period where participants receive either tulisokibart or placebo through subcutaneous injections, followed by a 124-week long-term extension divided into a 40-week main extension and an 84-week optional extension. This allows researchers to assess both the short-term and longer-term effects and safety of tulisokibart. Participants will be monitored for their response using the Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Throughout the study, researchers will evaluate disease activity and safety while tracking symptoms and any side effects. The total involvement spans up to 140 weeks, including both initial treatment and extension phases.

Research on personality disorders (PDs) in older adults is limited despite their common occurrence and significant impact on treatment due to coexisting mental and physical disorders. This study focuses on examining a new dimensional approach to diagnosing PDs, combining the Alternative Model for Personality Disorders (AMPD) and the ICD-11 criteria, which consider overall personality functioning and pathological personality traits. The aim is to evaluate whether this approach is suitable and clinically relevant for older adults compared to younger adults. Participants will complete two main self-report questionnaires, the PID-5-BF+M and the LPFS-BF 2.0, which assess maladaptive personality traits and personality functioning, respectively. The study will assess these questionnaires in both general and clinical populations, looking at validity, age-neutrality, and clinical utility. Additional clinical ratings and informant questionnaires will be collected for some patients using structured interviews. Several secondary questionnaires covering various psychological symptoms will also be analyzed retrospectively. During the study, participants will fill out the questionnaires and may be asked to have an informant complete an informant version. Researchers will evaluate personality disorder measures, their ability to differentiate PDs, and their relationship with other psychopathology symptoms. The study includes clinical ratings by trained students and retrospective analysis of test batteries. The primary outcomes include responses to the PID-5-BF+M and LPFS-BF 2.0 questionnaires within about one month of admission, with ongoing assessments to understand PD characteristics in older adults.

Researchers are investigating how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure with reduced or mildly reduced ejection fraction and left ventricular hypertrophy. This Phase 2 study compares CDR132L to a placebo, where participants receive either treatment randomly. The study aims to evaluate changes in a specific biomarker, microRNA-132-3p, over 24 weeks, with the total study duration lasting about 60 weeks. Participants will receive either CDR132L or a placebo through an intravenous infusion once every 4 weeks for a total of 48 weeks. The treatments are given under a double-blind design, meaning neither the participants nor the researchers know who receives which treatment until the study ends. This allows for a fair comparison of the effects of CDR132L versus placebo on heart structure and function. During the study, participants will undergo regular assessments including laboratory tests to measure heart-related biomarkers and imaging tests such as echocardiography to monitor heart structure and function. Researchers will track changes from baseline to week 24 in microRNA-132 levels and continue monitoring participants through the 60-week study period to evaluate safety and treatment effects. Ongoing clinical evaluations and safety checks will help ensure participant well-being throughout the trial.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are comparing the effectiveness of two treatments for participants with stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC) who have PD-L1 expression of 1% or higher. This phase 3, randomized, open-label study focuses on first-line treatment options and aims to evaluate overall survival over up to five years for participants with PD-L1 levels between 1% and 49%. The trial involves participants with measurable disease and good performance status who have not received prior systemic therapy for advanced disease. The study compares a combination of Nivolumab and Relatlimab plus chemotherapy against Pembrolizumab plus chemotherapy. Chemotherapy drugs include Carboplatin, Pemetrexed, and Cisplatin, administered at specified doses on scheduled days. Participants are randomly assigned to receive either the Nivolumab and Relatlimab combination with chemotherapy or Pembrolizumab with chemotherapy as their initial treatment. Treatment schedules and doses are defined but not detailed here. Participants will be closely monitored throughout the study, which may last up to five years. Researchers will assess overall survival as the primary outcome, along with regular imaging tests like CT or MRI to measure disease status. Eligibility screening includes assessing PD-L1 levels, performance status, and other health factors. Safety monitoring and follow-up will continue to evaluate treatment effects and participant well-being during and after treatment.

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

This trial studies adults aged 18 years and older with lung fibrosis caused by systemic autoimmune rheumatic diseases who have not shown lung function improvement after standard immunosuppressant treatment. It evaluates how the medicine nerandomilast affects lung disease associated with these conditions. The study is a phase 3, double-blind, randomized, placebo-controlled trial designed to test nerandomilast's safety and efficacy over at least 26 weeks. Participants are randomly assigned to receive either nerandomilast tablets or placebo tablets twice daily for a period of at least 26 weeks and up to 1 year. Alongside this, participants continue their ongoing immunosuppressant treatments for their rheumatic disease. The study involves two groups receiving either the active drug or placebo to compare outcomes between them. During the 7.5 to 13 months of participation, individuals visit the study site about 9 to 10 times for lung function tests, chest imaging at select visits, and to complete questionnaires about symptoms and quality of life. Researchers monitor changes in lung disease using high-resolution CT scans and assess safety by recording any side effects. The main outcome is the change in lung fibrosis score after 26 weeks of treatment.

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.

Anastomotic leakage (AL) is a serious complication after colon surgery, linked to higher mortality, lower quality of life, and increased healthcare costs. This research evaluates whether preventive endovascular stenting of a narrowed superior mesenteric artery (SMA) can reduce the risk of AL in patients aged 40 and older undergoing elective colon resection with primary anastomosis. The study is a nationwide multicenter randomized controlled trial involving patients with over 50% SMA stenosis, aiming to improve surgical outcomes and survival. Participants are randomly assigned to either receive preventive percutaneous transluminal angioplasty with a covered stent placed in the SMA before colon surgery or to undergo colon surgery without this stenting. Both groups receive mono antiplatelet therapy with daily Ascal (carbasalate calcium) to reduce atherosclerotic risks and maintain stent patency. The stenting procedure is ideally done within two weeks before surgery. Colon surgery follows standard protocols, and some centers use intraoperative fluorescence angiography to assess blood flow. During the 12-month follow-up, researchers monitor the occurrence of clinically relevant AL within 90 days after surgery as the primary outcome. They also assess AL severity, delayed leakage, surgical complications, hospital stays, readmissions, mortality, quality of life, and health economic impacts. Patient-reported outcomes are collected at multiple points post-surgery through questionnaires. Safety and stent performance are closely observed, with comprehensive data collected to evaluate the intervention's effectiveness and cost implications.

Researchers are studying actinic keratoses (AK), a skin condition, to compare two topical treatments. The purpose is to see if a shorter treatment combining 5-fluorouracil (5FU) and calcipotriol (CAL) is as effective as the standard 4-week 5FU treatment alone. The study addresses the challenge that 5FU, while effective, can cause side effects like redness, itching, burning, and crusting, and requires a long dosing schedule that may lead to poor patient adherence and treatment refusal. Combining CAL with 5FU may shorten treatment and improve tolerability by enhancing the immune response. Participants will receive one of two treatments: either the combination of 5FU and CAL applied topically twice daily for 4 or 6 consecutive days depending on the treatment location, or standard 5FU cream applied twice daily for 4 weeks. The trial is a phase 4 multicenter randomized controlled clinical trial comparing these regimens to evaluate treatment success at one year after treatment. This study focuses on maintaining the effectiveness of 5FU while reducing side effects and treatment duration. During the study, participants will be monitored for treatment success 12 months after finishing treatment. The researchers will assess the effectiveness and tolerability of the regimens, focusing on the long-term results. Participants must meet specified eligibility criteria, including confirmed AK diagnosis and lesion count, and will be followed to measure outcomes such as lesion clearance and side effects. The study aims to improve AK treatment adherence by offering a shorter, more tolerable option.