Ligelizumab in adolescents with chronic spontaneous urticaria: Results of a dedicated phase 2b randomized clinical trial supported with pharmacometric analysis.

Background: Chronic spontaneous urticaria (CSU), a long-lasting disease in children, impacts their quality of life. We report the results of a phase 2b dose-finding trial of ligelizumab (NCT03437278) and a high-affinity humanized monoclonal anti-IgE antibody, in adolescents with CSU, supported by modeling and simulation analyses, mitigating challenges in pediatric drug development.

Methods: This multicenter, double-blind, placebo-controlled trial, randomized H1-antihistamine-refractory adolescent CSU patients (12-18 years) 2:1:1 to ligelizumab 24 mg, 120 mg, or placebo every 4 weeks for 24 weeks.

Sliding tracheoplasty of complete tracheal cartilage rings in children.

Introduction: Complete tracheal rings are a rare malformation that occurs in 1 out of 100,000 live births. It is rare, isolated tracheal or tracheobronchial anomaly developed due to abnormal cartilage growth with formation of complete ring and often resulting in airway stenosis. Slide tracheoplasty, as it was originally described by Tsang et al.

Modelling Decline in Cognition to Decline in Function in Alzheimer's Disease.

Objectives: The study aimed to evaluate and quantify the temporal link between cognitive and functional decline, and assess the impact of the apolipoprotein E4 (APOE-e4) genotype on Alzheimer's disease (AD) progression.

Methods: A nonlinear mixed-effects Emax model was developed using longitudinal data from 659 patients with dementia due to AD sourced from the Alzheimer's disease neuroimaging initiative (ADNI) database. A cognitive decline model was first built using a cognitive subscale of the AD assessment scale (delayed word recall) as the endpoint, followed by a functional decline model, using the functional assessment questionnaire (FAQ) as the endpoint.

[Minimally Invasive Technologies in Surgery of the Chest Wall in Children].

Today, in our country, as well as throughout the world, there is no single approach to the tactics of managing patients with deformations of the anterior chest wall. These patients constitute a large and heterogeneous group. The team acquired great experience in treating children with pectus excavatum and pectus carinatum, as well as a unique experience in the surgical treatment of pediatric thoracic outlet syndrome and sternum clefts.