T-cell malignancies following CAR T-Cell therapy: insights from the FDA Adverse Event Reporting System (FAERS).

Background: Concern about post-CAR T-cell lymphomas has recently emerged. Analysis of pharmacovigilance data contributes to continuous safety monitoring, especially for newly authorized medicines, like CAR-T therapies.

Research Design And Methods: Individual case safety reports (ICSRs) reporting at least one CAR T-cell therapy as a suspect drug were extracted from the Food and Drug Administration Adverse Event Reporting System database up to 6 February 2024.

Real-World Safety Data of the Orphan Drug Onasemnogene Abeparvovec (Zolgensma) for the SMA Rare Disease: A Pharmacovigilance Study Based on the EMA Adverse Event Reporting System.

The recent introduction of the innovative therapy, onasemnogene abeparvovec (Zolgensma), has revolutionized the spinal muscular atrophy (SMA) therapeutic landscape. Although Zolgensma therapy has proven to lead to functional improvements in SMA children, some gaps in its safety profile still need to be investigated. To better characterize the Zolgensma safety profile, we conducted a retrospective observational study, analyzing all the Individual Case Safety Reports (ICSRs) referred to it and collected in the European pharmacovigilance database between 1 January 2019 and 22 September 2023.

Ultrasound findings in early congenital syphilis: Two case reports and literature review.

Syphilis is caused by treponema pallidum. If untreated, or inadequately treated, during pregnancy, it can result in congenital syphilis (CS), which is classified as early and late. Early CS displays before 2 years of age.

Perceptions and Expectations of Youth Regarding the Respect for Their Rights in the Hospital.

Information obtained from children themselves regarding the characteristics of the ideal hospital that ensure well-being during a hospital stay is scarce. Here, we report the opinions, perceptions, and expectations of 700 children and adolescents about their experiences, assessed through a mixed-method research approach with age-appropriate questionnaires, three open-ended questions, and an analysis of optional pictorial and textual narratives. Most children indicated that, while they acknowledged the expertise of hospital staff, they also noted several shortcomings, e.

Simple febrile seizures: new cut off for the duration of the crises.

Background: Our study aimed to identify a new cut-off for febrile seizure (FS) with a good prognosis, thereby replacing the 15 min described in the standard definition of simple febrile seizure (SFS).

Methods: Our study was a retrospective observational study (from January 2018 to December 2018) on children admitted to the Pediatric emergency room of the Santobono-Pausilipon Hospital, Naples, Italy, Pediatric Unit of Latina, Rome, Italy, and Policlinico-Vittorio-Emanuele University Hospital, Catania, Italy, for fever, which developed SFS during the hospitalization. All included patients had their seizures classified as SFS according to the international criteria for epilepsy.

Static cutoffs or tables for the diagnosis of hypertension? Effect on identification of organ damage in youths with obesity.

Background And Aim: Recently, the European Society of Cardiology task force released a Consensus document (ESC-CD) on pediatric hypertension (HTN) supporting the use of normative tables (age range 6-16 years) for the diagnosis of HTN, while the Hypertension Canada Guidelines (HTN-CGs) proposed static cutoffs. We aimed to assess the prevalence of HTN by ESC-CD or HTN-CGs and their association with glomerular function and left ventricular (LV) geometry in youths with overweight/obesity (OW/OB).

Methods And Results: Data of 3446 youths were analyzed.

Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study.

Introduction: Although the European Medicines Agency (EMA) encourage coronavirus disease 2019 (COVID-19) vaccination in pregnant women, the scientific evidence supporting the use of COVID-19 vaccines during pregnancy is still limited.

Aim: We aimed to investigate adverse events following immunization (AEFI) with COVID-19 vaccines during pregnancy.

Methods: We retrieved Individual Case Safety Reports (ICSRs) related to the use of COVID-19 vaccines during pregnancy from the EudraVigilance database for the year 2021.

Acute ischemic stroke secondary to ventriculoperitoneal shunt dysfunction in a child with Moyamoya syndrome.

Background: Patients with brain vascular disease and hydrocephalus may be predisposed to acute ischemic stroke in case of shunt dysfunction and subsequent increased intracranial pression. Patients with brain tumor may develop hydrocephalus as a consequence of obstruction of cerebrospinal fluid pathways and radiation-induced moyamoya syndrome secondary (RIMS) to radiotherapy (RT).

Case Description: A 15-year-old male patient, affected by hydrocephalus and RIMS, presented acute cerebral ischemia after an episode of shunt malfunction.

Skin Manifestations and Coeliac Disease in Paediatric Population.

Celiac disease (CD) is an immune-mediated enteropathy caused by gluten ingestion, affecting approximately 1% of the worldwide population. Extraintestinal symptoms may be present as the first signs of CD, years before the CD diagnosis is made. A great variety of extraintestinal manifestations may be associated with CD.

Infection control strategy and primary care assistance in Campania region during the national lockdown due to COVID-19 outbreak: the experience of two tertiary emergency centers.

Background: COVID-19 pandemic has markedly affected emergency care, due to sudden limitation of health care capacity by general practitioners (GP) and urgent need for infection control strategies. We evaluated the activity of the Emergency Department (ED) during the national lockdown (March 8-April 30), as well as the outcomes of our infection control strategy.

Results: Despite a reduction in access by one fifth, a proportion of febrile patients comparable to 2019 was seen (829/2492, 33.

Neonatal teeth: Importance of histological findings in management update.

Background: Presence of teeth in a newborn represents a rare finding and a disturbance of biological chronology of teeth. The aim of this paper is to report two cases with neonatal teeth histologically examined.

Case Report: In this paper two cases of patients with neonatal teeth are reported and histological examinations of three extracted teeth are described.

Effect of Population Lockdown on Pediatric Emergency Room Demands in the Era of COVID-19.

The aim of this study was to assess the impact of the COVID-19 pandemic and population lockdown on pediatric ED consultations. A cross-sectional study on pediatric emergency department consultations before and during the current COVID-19 pandemic (March-May 2019 vs. March-May 2020) was performed in two hospitals in the Campania region (Southern Italy) [i.

An alternative to plaster cast treatment in a pediatric trauma center using the CAD/CAM technology to manufacture customized three-dimensional-printed orthoses in a totally hospital context: a feasibility study.

The aim of this study is to implement the clinical use of the three-dimensional (3D) design and printing technology in pediatric pathologies requiring immobilization. We describe the manufacturing process of the 3D device in place of the plaster cast usually applied to a child 48/72 h after the access to the Trauma Center Traumatology Hub. This procedure had already been performed at Level II, Trauma Center, Campania Region, Orthopaedic Division of Santobono Children's Hospital, Naples, Italy.