Postmarketing observational study on the safety of 2021/2022 and 2022/2023 influenza vaccination campaigns in Italy: TheShinISS-Vax|Flu study protocol.

Introduction: The purpose of TheShinISS-Vax|Flu study is to examine the association between influenza vaccines and adverse events requiring hospital admission or emergency care during the influenza vaccination campaigns 2021/2022 and 2022/2023 in Italy.

Methods And Analysis: This is a Self-Controlled Case Series multiregional study using linked routinely collected data from regional healthcare databases of the participating regions. Study participants will be persons aged ≥6 months, unvaccinated or who have received influenza vaccine during the influenza vaccination campaigns in the seasons 2021/2022 and 2022/2023 in Italy and who have experienced the outcome of interest for the first time during the study period (1 September 2021-30 June 2022 and 1 September 2022-30 June 2023 for the first and second vaccination campaigns, respectively).

Is PEGylation of Drugs Associated with Hypersensitivity Reactions? An Analysis of the Italian National Spontaneous Adverse Drug Reaction Reporting System.

Background And Objective: Evidence highlights the allergenic potential of PEGylated drugs because of the production of anti-polyethylene glycol immunoglobulins. We investigated the risk of hypersensitivity reactions of PEGylated drugs using the Italian spontaneous adverse drug reaction reporting system database.

Methods: We selected adverse drug reaction reports attributed to medicinal products containing PEGylated active substances and/or PEGylated liposomes from the Italian Spontaneous Reporting System in the period between its inception and March 2021.

Postmarketing active surveillance of myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines in persons aged 12 to 39 years in Italy: A multi-database, self-controlled case series study.

Background: Myocarditis and pericarditis following the Coronavirus Disease 2019 (COVID-19) mRNA vaccines administration have been reported, but their frequency is still uncertain in the younger population. This study investigated the association between Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA vaccines, BNT162b2, and mRNA-1273 and myocarditis/pericarditis in the population of vaccinated persons aged 12 to 39 years in Italy.

Methods And Findings: We conducted a self-controlled case series study (SCCS) using national data on COVID-19 vaccination linked to emergency care/hospital discharge databases.

Vaccines for measles, mumps, rubella, and varicella in children.

Background: Measles, mumps, rubella, and varicella (chickenpox) are serious diseases that can lead to serious complications, disability, and death. However, public debate over the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists, despite its almost universal use and accepted effectiveness. This is an update of a review published in 2005 and updated in 2012.

Pediatric adverse reactions to antiseizure medications - An analysis of data from the Italian spontaneous reporting system (2001-2019).

Introduction: Spontaneous reports of adverse drug reactions (ADRs) are a valuable supplement to clinical studies in informing about the safety of medications. This is especially relevant for pediatric populations, which are not often included in large-scale clinical trials.

Objectives: To evaluate patterns of pediatric ADRs to antiseizure medications (ASMs) reported to the Italian Spontaneous Reporting System (SRS) database during the period November 1, 2001─May 31, 2019.

Vaccines for measles, mumps, rubella, and varicella in children.

Background: Measles, mumps, rubella, and varicella (chickenpox) are serious diseases that can lead to serious complications, disability, and death. However, public debate over the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists, despite its almost universal use and accepted effectiveness. This is an update of a review published in 2005 and updated in 2012.

Radiation-induced anaplastic ependymoma mimicking a skull base meningioma: A case report.

The present study describes the case of a 63-year-old woman presenting with headache, dizziness and vomiting due to a an ovoid mass in the left pre-bulbar cistern, apparently arising from the lower clivus and the foramen magnum. The clinical history revealed the subtotal removal of a right cerebellar low-grade glioma 15 years previously and subsequent conventional 60-Gy radiotherapy. Notably, following gross total resection, histopathological examination showed microscopic features that resulted in a diagnosis of anaplastic ependymoma.

Early versus delayed rehabilitation treatment in hemiplegic patients with ischemic stroke: proprioceptive or cognitive approach?

Background: Early/intensive mobilization may improve functional recovery after stroke but it is not clear which kind of "mobilization" is more effective. Proprioceptive neuromuscular facilitation (PNF) and cognitive therapeutic exercise (CTE) are widespread applied in post-stroke rehabilitation but their efficacy and safety have not been systematically investigated.

Aim: To compare PNF and CTE methods in a two different time setting (early versus standard approach) in order to evaluate different role of time and techniques in functional recovery after acute ischemic stroke.

Intracranial hemodynamic changes in primary Sjögren syndrome: a transcranial Doppler case-control study.

The aim of this case-control study is to evaluate the cerebral hemodynamic parameters in primary Sjögren syndrome patients by means of transcranial Doppler and the possible relationship with neuroimaging structural alteration, immunological markers and subclinical neurological involvement. 87 consecutive treatment-naïve outpatients with primary Sjögren syndrome and 86 age- and sex-matched healthy controls underwent transcranial Doppler for bilateral measurement of mean flow velocities, pulsatility index and systolic-diastolic ratio, brain magnetic resonance imaging, clinical evaluation with neuropsychological test and serological assessment. 28 patients and 4 controls (32 vs.

Atorvastatin treatment and carotid plaque morphology in first-ever atherosclerotic transient ischemic attack/stroke: a case-control study.

Background: A relationship between echolucency of carotid plaques and the consequent risk of ipsilateral ischemic stroke has been observed. An aggressive lipid-lowering therapy may increase the echogenicity of carotid plaque in patients with elevated low-density lipoprotein cholesterol levels. The aim of this study is to prospectively evaluate the long-term effect of high-dose atorvastatin on carotid plaque morphology in patients with first-ever transient ischemic attack or stroke.

Ultrasonographic evaluation of cerebral arterial and venous haemodynamics in multiple sclerosis: a case-control study.

Objective: Although recent studies excluded an association between Chronic Cerebrospinal Venous Insufficiency and Multiple Sclerosis (MS), controversial results account for some cerebrovascular haemodynamic impairment suggesting a dysfunction of cerebral autoregulation mechanisms. The aim of this cross-sectional, case-control study is to evaluate cerebral arterial inflow and venous outflow by means of a non-invasive ultrasound procedure in Relapsing Remitting (RR), Primary Progressive (PP) Multiple Sclerosis and age and sex-matched controls subjects.

Material And Methods: All subjects underwent a complete extra-intracranial arterial and venous ultrasound assessment with a color-coded duplex sonography scanner and a transcranial doppler equipment, in both supine and sitting position by means of a tilting chair.

Reversible Pisa syndrome associated to subdural haematoma: case-report.

Background: Pisa Syndrome or Pleurothotonus is a relatively rare truncal dystonia, characterized by tonic flexion of the trunk and head to one side with slight rotation of the body. Since frequently associated to specific drugs such as antipsychotics and cholinesterase inhibitors or to Parkinson Disease, a pathophysiological role of cholinergic-dopaminergic imbalance has been suggested. We report here the first case of Pisa Syndrome due to an extracerebral pathology as subdural haematoma.

Neurological involvement in primary Sjögren syndrome: a focus on central nervous system.

Objectives: Sjögren syndrome is an autoimmune disease involving mainly salivary and lacrimal glands. Beyond widely described PNS involvement, high variable prevalence of CNS manifestations ranging from 2.5 and 60% of all pSS patients has been reported, without specific syndrome definition.

Clinical implications of patent foramen ovale in migraine with aura.

The high incidence of patent foramen ovale (PFO) in migraine with aura (MWA) is well known. In this study we evaluated the relationship between PFO and aura features, and the relative impact of this association on stroke risk. We recruited patients with a diagnosis of MWA.