Poria Neve Oved

Researchers are evaluating the efficacy and safety of belimumab compared to a placebo, both given alongside standard therapy, for adults with systemic sclerosis associated interstitial lung disease SSc-ILD. The study aims to assess how belimumab affects lung function, skin thickening, and symptoms like fatigue that influence quality of life in these patients. This is a Phase 23 randomized, double-blind, placebo-controlled trial sponsored by GlaxoSmithKline. Participants will be randomly assigned to receive either belimumab or a placebo, both administered subcutaneously along with standard therapy. The treatment period lasts 52 weeks, during which the effects on lung function and skin symptoms will be closely monitored. The study involves two groups one receiving belimumab plus standard care and the other receiving placebo plus standard care. During the study, participants will undergo assessments including lung function tests such as Forced Vital Capacity FVC, skin thickness scoring, fatigue evaluations, and quality of life questionnaires at baseline and Week 52. Researchers will also track any adverse events and serious side effects. The main outcome measured is the change in lung function after 52 weeks. Participants will be monitored regularly throughout the 52-week treatment period to evaluate treatment effects and safety.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

Researchers are evaluating the feasibility, initial safety, and performance of the Vsling device in patients with heart failure who have a reduced left ventricular ejection fraction and ventricular dilation. This Phase 2, multi-center, open-label clinical study focuses on patients with heart failure and aims to assess how well the Vsling device works for ventricular repair. The study is sponsored by Cardiac Success and targets adults aged 18 years and older. Participants will receive the Vsling device implantation, an implantable ventricular repair device designed to support heart function. The study does not involve a control group or placebo. The treatment is delivered through the implantation procedure, and the trial will monitor participants primarily for serious adverse events related to the device within 30 days of implantation. During the study, participants will be closely monitored for safety and device performance. Assessments will include heart function evaluations and clinical status according to various heart failure classifications. Researchers will track device-related serious adverse events for 30 days post-implantation. The study will continue until April 2031, with participant involvement including follow-up visits to ensure safety and gather performance data.