Quetzaltenango

Traumatic brain injury (TBI) is a major cause of death and disability among children worldwide, especially severe TBI in children and adolescents. This trial focuses on whether treatment guided by invasive intracranial pressure (ICP) monitoring improves outcomes compared to treatment based on imaging and clinical exams alone. Conducted in eight Latin American pediatric intensive care units, the study also aims to build research skills among pediatric intensivists in the region and inform global clinical practice for managing severe pediatric TBI. The study compares two management protocols for children aged 1 to 12 years with severe TBI. One group receives care guided by ICP monitoring, while the other group's treatment is based on imaging and clinical assessments without ICP monitoring. Children must be enrolled within 24 hours of injury or deterioration and meet specific neurological criteria. The trial is a randomized controlled design with 428 participants, conducted in hospitals equipped to provide high-quality trauma care. Participants will be followed for at least six months, during which researchers will measure quality of life using the Pediatric Quality of Life Inventory (PedsQL) as the primary outcome. Other assessments include mortality, global outcomes, complications, ICU length of stay, and brain-specific treatments. The study involves close monitoring of neurological status and treatment effects to understand the benefits and risks of ICP monitoring in severe pediatric TBI care.

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab given every 4 weeks or every 12 weeks compared to placebo, all combined with standard-of-care therapy, in adults with active lupus nephritis. This phase 3 trial focuses on participants with specific classes of lupus nephritis confirmed by recent kidney biopsy and meeting established diagnostic criteria. Participants will receive either ianalumab every 4 weeks, ianalumab every 12 weeks, or a placebo, all given by subcutaneous injection alongside standard lupus nephritis treatment. Standard-of-care includes induction therapy with high-dose corticosteroids and mycophenolic acid (MPA). Treatment schedules and doses are carefully monitored throughout the study. Participants will be involved in regular assessments including kidney function tests, urine protein measurements, and clinical evaluations up to week 72 to monitor treatment response and safety. The primary outcome is the frequency of participants achieving stable complete renal response by week 72. Safety and tolerability are also closely tracked during the trial period.