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.

Possible clinical and radiological predictors of haemorrhagic transformation in acute stroke patients undergoing dual antiplatelet therapy: a clinical study.

Background: The predictors of intracranial haemorrhagic transformation (HT) in acute ischaemic stroke (AIS) patients undergoing dual antiplatelet therapy (DAPT) are not well known.

Objectives: The aim of this study is to identify the possible clinical and radiological predictors of HT in patients, irrespective of clinical indication for this treatment.

Design: This study is a monocentric cohort retrospective study.

Safety of dapagliflozin and empagliflozin in cases with diabetes mellitus or/and heart failure: a retrospective pharmacovigilance study conducted on the eudravigilance database.

Introduction: Dapagliflozin and empagliflozin are sodium-glucose cotransporter-2 (SGLT2) inhibitors initially approved for the treatment of type 2 diabetes mellitus (DM), and later for heart failure (HF). Considering this differential therapeutic use, we decided to evaluate cases related to these agents by comparing those with DM, HF, or both (DM and HF).

Methods: A retrospective, pharmacovigilance study was conducted by using data contained in the EudraVigilance from January 1st, 2021, to December 31st, 2023.

Safety and efficacy of bridging intravenous thrombolysis plus mechanical thrombectomy versus direct mechanical thrombectomy in different age groups of acute ischemic stroke patients.

Objective: To evaluate the safety and efficacy of bridging intravenous thrombolysis plus mechanical thrombectomy (MT) versus direct MT in different age groups of patients with acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO) of the anterior circulation.

Methods: Consecutive patients from the prospective endovascular stroke registry of the Comprehensive Stroke Center, University of Rome Tor Vergata, Italy, between January 2015 and June 2021 were retrospectively analyzed. Patients were divided into age groups (≤ 80 years old and > 80 years old); for each age group, they were further divided in the bridging therapy group and the direct MT group.

Risk of Rhabdomyolysis Associated with Dexmedetomidine Use over the Past 10 Years: Insights from the EudraVigilance Database.

Dexmedetomidine, a selective α2-adrenergic agonist, is favoured in intensive care for its minimal respiratory depression. This study evaluated the reporting frequency of rhabdomyolysis with dexmedetomidine compared to midazolam and propofol using the European pharmacovigilance database Eudravigilance. We conducted an observational, retrospective analysis of Individual Case Safety Reports (ICSRs) from 1 January 2013, to 31 December 2023.

Safety profile of trastuzumab originator vs biosimilars: a systematic review and meta-analysis of randomized clinical trials.

Purpose: In the last decade trastuzumab biosimilars became more and more frequent. Among their uses, from several years, they have been available in Europe for the treatment of HER2-positive metastatic breast cancer, as an alternative to Herceptin®.

Methods/patients: This meta-analysis aimed to analyze the available literature with particular focus on phase 3 randomized clinical trials (RCTs) comparing adverse events between trastuzumab biosimilar and originator.

The Early Access and the Potential Cost Savings by the Compassionate Use of Onco-haematological Drugs: Results from the Italian Study Compass-O.

Background: Compassionate drug use (CDU) provides early access to not yet authorised medicines and is funded by pharmaceutical companies. The observational retrospective study Compass-O monitored the CDU of onco-haematological drugs, managed by seven Italian units for cytotoxic drug preparations (Unità Farmaci Antiblastici [UFA]), between 1 January, 2016 and 31 December, 2021.

Objective: We aimed to evaluate the CDU of onco-haematological drugs managed by seven Italian UFA, between 2016 and 2021.

Intersectionality informed and narrative-shifting whole school approaches for LGBTQ+ secondary school student mental health: A UK qualitative study.

School is a key site for prevention and early intervention in public mental health, with sexual and gender minority students being a priority group for action. Context is important in understanding how school inclusion of sexual and gender minorities shapes mental health and well-being, with rapidly changing social and political forces necessitating ongoing research. This coproduced UK secondary school-based study aimed to understand (a) key components of mentally, socially and emotionally healthy school environments for LGBTQ+ students considerate of intersecting minoritised identities; (b) staff information, skills and capacity needs and (c) factors influencing uptake and implementation.

Comprehensive analysis of clinical outcomes, infectious complications and microbiological data in newly diagnosed multiple myeloma patients: a retrospective observational study of 92 subjects.

Patients with multiple myeloma (MM) have an increased risk of sepsis due to underlying disease- and treatment-related immunosuppression. However, data on sepsis incidence, causative pathogens, and impact on outcomes in newly diagnosed MM (NDMM) are limited. We conducted a retrospective observational study of 92 NDMM patients who developed sepsis between 2022 and 2023 at a tertiary care center in Italy.

Association between procedural time and outcome in unsuccessful mechanical thrombectomy for acute ischemic stroke: analysis from the Italian Registry of Endovascular Treatment in Acute Stroke.

Background: We aim to assess the association between procedural time and outcomes in patients in unsuccessful mechanical thrombectomy (MT) for anterior circulation acute stroke.

Methods: We conducted a cohort study on prospectively collected data from patients with M1 and/or M2 segment of middle cerebral artery occlusion with a thrombolysis in cerebral infarction 0-1 at the end of procedure. Primary outcome was 90-day poor outcome.

Coupling Different Road Traffic Noise Models with a Multilinear Regressive Model: A Measurements-Independent Technique for Urban Road Traffic Noise Prediction.

Road traffic noise is a severe environmental hazard, to which a growing number of dwellers are exposed in urban areas. The possibility to accurately assess traffic noise levels in a given area is thus, nowadays, quite important and, on many occasions, compelled by law. Such a procedure can be performed by measurements or by applying predictive Road Traffic Noise Models (RTNMs).

Endovascular treatment of acute arteriosclerotic vertebrobasilar occlusion: A single center experience.

Objectives: Few experiences on vertebrobasilar occlusion over underlying intracranial atherosclerotic disease have been reported in literature and the optimal strategy on how to perform a mechanical thrombectomy is unclear. The aim of this paper is to bring our experience based on patients admitted with acute vertebrobasilar occlusion with underlying atheromatous lesions.

Materials And Methods: Several data were collected from August 2009 to October 2022 including clinical history, pre- and post-treatment neurological objectivity, diagnostic images and angiographic procedural images, and clinical outcome at 6 months.

Disease-Modifying Therapies (DMTs) in Pregnant and Lactating Women with Multiple Sclerosis: Analysis of Real-World Data from EudraVigilance Database.

(1) Background: The purpose of study was to compare the safety profile of glatiramer with natalizumab, alemtuzumab and ocrelizumab in pregnant and lactating women affected by multiple sclerosis (MS). (2) Methods: Individual case safety reports (ICSRs) were retrieved from the European spontaneous reporting system database (EudraVigilance). The reporting odds ratios (RORs) were computed to compare the reporting probability of events between natalizumab, alemtuzumab and ocrelizumab vs.

COVID-19 outbreak in Italy: an opportunity to evaluate extended interval dosing of ocrelizumab in MS patients.

Introduction: During the COVID-19 pandemic, ocrelizumab (OCR) infusions for MS patients were often re-scheduled because of MS center's disruption and concerns regarding immunosuppression. The aim of the present study was to assess changes in OCR schedule during the first wave of pandemic in Italy and to evaluate the effect of delayed infusion on clinical/radiological endpoints.

Methods: Data were extracted from the Italian MS Register database.

Thromboembolic Events after COVID-19 Vaccination: An Italian Retrospective Real-World Safety Study.

Introduction: Real-world safety studies can provide important evidence on the thromboembolic risk associated with COVID-19 vaccines, considering that millions of people have been already vaccinated against COVID-19. In this study, we aimed to estimate the incidence of thromboembolic events after COVID-19 vaccination and to compare the Oxford-AstraZeneca vaccine with other COVID-19 vaccines.

Methods: We conducted a retrospective real-world safety study using data from two different data sources: the Italian Pharmacovigilance database (Rete Nazionale di Farmacovigilanza, RNF) and the Campania Region Health system (Sistema INFOrmativo saNità CampanIA, SINFONIA).

Retrospective Analysis of a Real-Life Use of Tixagevimab-Cilgavimab plus SARS-CoV-2 Antivirals for Treatment of COVID-19.

Tixagevimab-cilgavimab is effective for the treatment of early COVID-19 in outpatients with risk factors for progression to severe illness, as well as for primary prevention and post-exposure prophylaxis. We aimed to retrospectively evaluate the hospital stay (expressed in days), prognosis, and negativity rate for COVID-19 in patients after treatment with tixagevimab-cilgavimab. We enrolled 42 patients who were nasal swab-positive for SARS-CoV-2 (antigenic and molecular)-both vaccinated and not vaccinated for COVID-19-hospitalized at the first division of the Cotugno Hospital in Naples who had received a single intramuscular dose of tixagevimab-cilgavimab (300 mg/300 mg).

Venous thromboembolism with use of hormonal contraception and non-steroidal anti-inflammatory drugs: nationwide cohort study.

Objective: To study the influence of concomitant use of hormonal contraception and non-steroidal anti-inflammatory drugs (NSAIDs) on the risk of venous thromboembolism.

Design: Nationwide cohort study.

Setting: Denmark through national registries.

Which is the top player for the cardiovascular safety? ibrutinib vs. obinutuzumab in CLL.

Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, is authorized for the treatment of chronic lymphocytic leukemia (CLL). This study aims to explore the cardiac safety profile of ibrutinib in comparison with obinutuzumab. A retrospective pharmacovigilance study was conducted on data retrieved from the European pharmacovigilance database (Eudravigilance) from 1 January 2014 to 30 September 2022.

Aspiration thrombectomy of M2 segment in acute ischemic stroke: The clinical reality in a neurovascular reference center.

Objective: Our study aimed to evaluate safety, efficacy and clinical outcomes in patients with acute ischemic stroke with occlusion of M2 segment treated with thromboaspiration.

Materials And Methods: A retrospective study was conducted in patients with ischemic stroke of M2 segment undergoing endovascular thromboaspiration. The time period analyzed was from October 2015 until February 2021.

What Is the Role of Nutraceutical Products in Cancer Patients? A Systematic Review of Randomized Clinical Trials.

Chemotherapy represents the main pharmacological cancer treatment. Recently, positive effects emerged with the combination of anticancer therapy and nutraceutical products. The aim of this systematic review is to collect and synthesize the available scientific evidence regarding the potential effects of nutraceuticals on cancer cells.

Comparison between different referral strategies for acute ischemic stroke patients in a hub-spoke emergency stroke network: a real-world experience in south-east Lazio.

Aim: To describe different referral strategies for acute ischemic stroke (AIS) patients in a Hub-Spoke emergency stroke network with their incidence, time metrics and related outcomes.

Methods: Referral paradigms were defined as follows: primary transfer to the comprehensive stroke center (CSC) from a remote region, called mothership (MS); secondary transfer to the CSC from a primary stroke center where intravenous thrombolysis was available, called drip and ship (DS); secondary transfer to the CSC from a community hospital where no reperfusion therapy was available, called ship and drip (SD); primary transfer to the CSC from its catchment area, called direct CSC (dCSC).

Results: Among 517 anterior circulation AIS patients treated with mechanical thrombectomy between 2015 and 2020, 16.