Be Er Sheva

Researchers are evaluating the safety and effectiveness of once-weekly Somatrogon compared to daily Growth Hormone Genotropin for treating children born Small for Gestational Age SGA or with Idiopathic Short Stature ISS. This randomized, open-label study involves pre-pubertal children who have not previously received growth hormone treatment. The study is planned to last 12 months, including a screening period of up to 30 days, and aims to measure growth outcomes in these children. The study includes two groups one with 140 children with SGA and another with 114 children with ISS. Both groups will be randomly assigned to receive either Somatrogon once weekly via a subcutaneous disposable prefilled pen or Genotropin daily subcutaneous injections using commercial growth hormone delivery devices. Treatment will continue for 12 months for all participants. Participants will be involved in regular visits to assess growth through measurements such as annual height velocity, height standard deviation scores, bone maturation, and levels of Insulin-like Growth Factor-1 IGF-1. Quality of life related to health will also be evaluated before and after treatment. Monitoring includes laboratory tests and maintaining stable hormone levels. The total participation duration includes the screening and 12 months of treatment, with assessments at multiple time points throughout the study.

Mycobacterium abscessus MABS is a group of rapidly growing bacteria resistant to many drugs, causing lung infections that can lead to serious health problems, decreased lung function, and higher risk during lung transplants. The prevalence of MABS infections is increasing globally despite the relatively small number of affected people. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment FORMaT trial aims to identify the best treatment combinations to improve health outcomes while reducing side effects and treatment burden. It also seeks to develop biomarkers to guide treatment decisions and assess disease severity in patients with MABS pulmonary disease MABS-PD. The trial is an ongoing, adaptive study designed to test and improve combinations of therapies for both children and adults with MABS-PD. Participants receive various drug treatments including intravenous therapies such as amikacin, tigecycline, cefoxitin or imipenem combined with oral antibiotics like azithromycin, clarithromycin, and clofazimine. The study includes phases of intensive intravenous therapy followed by consolidation therapy with oral andor inhaled antibiotics. Treatments can be adjusted based on tolerance and microbiological response, with new therapies added or removed as evidence evolves. Participants are involved in screening, treatment, and follow-up visits extending up to 62 weeks. The study monitors microbiological clearance of infection alongside treatment tolerance. Assessments include lung function tests, chest CT scans, quality of life questionnaires, six-minute walk tests, and evaluation of treatment safety and resistance. Researchers also study health costs and reasons for early withdrawal. This comprehensive monitoring helps understand how treatments affect disease control, lung health, and patient well-being over time.