Poria Neve Oved

Researchers are evaluating the efficacy and safety of belimumab compared to a placebo, alongside standard therapy, for adults with systemic sclerosis associated interstitial lung disease (SSc-ILD). This Phase 2/3 randomized, double-blind study aims to assess how belimumab affects lung function and other disease symptoms such as skin thickening and fatigue, which impact quality of life. Participants will receive either belimumab or placebo administered subcutaneously. The study focuses on those diagnosed with diffuse cutaneous systemic sclerosis and active or progressive disease. Treatment is given under blinded conditions, and participants must be capable of self-administering the medication or have a caregiver to assist. During the study, lung function will be monitored by measuring changes in forced vital capacity (FVC) from baseline to Week 52. Researchers will also assess skin involvement and general symptoms. Safety and tolerability will be closely followed throughout the trial, which includes screening and regular assessments to evaluate treatment effects and participant well-being.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

Researchers are conducting a prospective, multi-center, open-label Phase 2 clinical study to evaluate the feasibility, initial safety, and performance of the Vsling17 device in patients with heart failure who have reduced left ventricular ejection fraction and ventricular dilation. The study focuses on patients with cardiomyopathy of ischemic or non-ischemic origins and mild or less functional mitral regurgitation. The device is designed to help repair the ventricle in this specific group of heart failure patients. Participants will receive the Vsling17, an implantable ventricular repair device intended to improve heart function. The study includes patients aged 18 years or older who meet specific heart function and anatomical criteria. The procedure involves implanting the Vsling17 device via catheter, with careful assessment to ensure safe passage. The study does not mention comparator groups or additional treatments. During the study, participants will be closely monitored for device-related serious adverse events within 30 days. Various assessments including echocardiography and clinical evaluations will be performed to track heart function and safety. Participants will provide informed consent and be followed to assess the device's performance and safety over time, with attention to any complications or impacts on heart failure symptoms and overall health.