Effect of RNS60 in amyotrophic lateral sclerosis: a phase II multicentre, randomized, double-blind, placebo-controlled trial.

Background And Purpose: Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease with limited treatment options. RNS60 is an immunomodulatory and neuroprotective investigational product that has shown efficacy in animal models of ALS and other neurodegenerative diseases. Its administration has been safe and well tolerated in ALS subjects in previous early phase trials.

Off-Adherence Keeping (OAK) observational study: intentional off-adherence immunomodulatory multiple sclerosis treatment.

To evaluate how improved treatment adherence with a lower-frequency regimen/treatment of intramuscular (IM) IFNβ-1a impacts therapeutic effectiveness in relapsing-remitting multiple sclerosis (MS) patients switching from a higher-frequency injectable regimen/treatment. Italian patients with relapsing-remitting MS and prior poor adherence to high-frequency injectable treatments (n = 181) were followed for 24 months after starting IM IFNβ-1a. During the study, 97.

Early Spondyloarthritis Clinic: Organizational Improvements in the Patient Journey.

Spondyloarthritis are chronic inflammatory diseases affecting spine, peripheral joints and enthesis, as well as extra-articular sites (bowel, eyes, skin). Diagnosis of spondyloarthritis often is slow and requires a multidisciplinary approach. The "Early SpA Clinic" project aimed at improving the patient care and journeys, by solving some organizational issues existing in Rheumatology Clinics.

Evaluation of Alpha-Synuclein Cerebrospinal Fluid Levels in Several Neurological Disorders.

(1) Background: Alpha-synuclein (α-syn) is a presynaptic neuronal protein that regulates several neuronal functions. In recent decades, the role of α-syn as a biomarker of neurodegenerative diseases has been explored, especially in synucleinopathies. However, only a few studies have assessed its role as biomarker in other neurological disorders.

Longitudinal analysis of anti-SARS-CoV-2 S-RBD IgG antibodies before and after the third dose of the BNT162b2 vaccine.

Immunosurveillance by evaluating anti-spike protein receptor-binding domain (S-RBD) antibodies represents a useful tool to estimate the long immunity against Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) infection. The aim of this study was to evaluate the kinetics of antibody response in vaccine recipients. We measured anti-S-RBD IgG levels by indirect chemiluminescence immunoassay on Maglumi 800 (SNIBE, California) in 1013 healthy individuals naïve to SARS-CoV2 infection after two and three COVID-19 vaccine doses.

Excimer laser technology in percutaneous coronary interventions: Cardiovascular laser society's position paper.

Excimer Laser Coronary Atherectomy (ELCA) is a well-established therapy that emerged for the treatment of peripheral vascular atherosclerosis in the late 1980s, at a time when catheters and materials were rudimentary and associated with the most serious complications. Refinements in catheter technology and the introduction of improved laser techniques have led to their effective use for the treatment of a wide spectrum of complex coronary lesions, such as thrombotic lesions, severe calcific lesions, non-crossable or non-expandable lesions, chronic occlusions, and stent under-expansion. The gradual introduction of high-energy strategies combined with the contrast infusion technique has enabled us to treat an increasing number of complex cases with a low rate of periprocedural complications.

Neurogranin as a Reliable Biomarker for Synaptic Dysfunction in Alzheimer's Disease.

(1) Background: Neurogranin is a post-synaptic protein expressed in the neurons of the hippocampus and cerebral cortex. It has been recently proposed as a promising biomarker of synaptic dysfunction, especially in Alzheimer's disease (AD). However, more efforts are needed before introducing it in clinical practice, including the definition of its reference interval (RI).

Infodemiology of flu: Google trends-based analysis of Italians' digital behavior and a focus on SARS-CoV-2, Italy.

Introduction: The aim of the current study was to assess if the frequency of internet searches for influenza are aligned with Italian National Institute of Health (ISS) cases and deaths. Also, we evaluate the distribution over time and the correlation between search volume of flu and flu symptoms with reported new cases of SARS-CoV-2.

Materials And Methods: The reported cases and deaths of flu and the reported cases of SARS-CoV-2 were selected from the reports of ISS, the data have been aggregated by week.

Comparative Analysis of BIOCHIP Mosaic-Based Indirect Immunofluorescence with Enzyme-Linked Immunosorbent Assay for Diagnosing Myasthenia Gravis.

Background: The detection of anti-acetylcholine receptor (AChR) and anti-muscle-specific tyrosine kinase (MuSK) antibodies is useful in myasthenia gravis (MG) diagnosis and management. BIOCHIP mosaic-based indirect immunofluorescence is a novel analytical method, which employs the simultaneous detection of anti-AChR and anti-MuSK antibodies in a single miniature incubation field. In this study, we compare, for the first time, the BIOCHIP MG mosaic with conventional enzyme-linked immunosorbent assay (ELISA) in the diagnosis of MG.

Hemithyroidectomy versus total thyroidectomy in the intermediate-risk differentiated thyroid cancer: the Italian Societies of Endocrine Surgeons and Surgical Oncology Multicentric Study.

The surgical treatment of the intermediate-risk DTC (1-4 cm) remains still controversial. We analyzed the current practice in Italy regarding the surgical management of intermediate-risk unilateral DTC to evaluate risk factors for recurrence and to identify a group of patients to whom propose a total thyroidectomy (TT) vs. hemithyroidectomy (HT).

SIRM-SIC appropriateness criteria for the use of Cardiac Computed Tomography. Part 1: Congenital heart diseases, primary prevention, risk assessment before surgery, suspected CAD in symptomatic patients, plaque and epicardial adipose tissue characterization, and functional assessment of stenosis.

In the past 20 years, Cardiac Computed Tomography (CCT) has become a pivotal technique for the noninvasive diagnostic work-up of coronary and cardiac diseases. Continuous technical and methodological improvements, combined with fast growing scientific evidence, have progressively expanded the clinical role of CCT. Recent large multicenter randomized clinical trials documented the high prognostic value of CCT and its capability to increase the cost-effectiveness of the management of patients with suspected CAD.

Morbidity and mortality after anaesthesia in early life: results of the European prospective multicentre observational study, neonate and children audit of anaesthesia practice in Europe (NECTARINE).

Background: Neonates and infants requiring anaesthesia are at risk of physiological instability and complications, but triggers for peri-anaesthetic interventions and associations with subsequent outcome are unknown.

Methods: This prospective, observational study recruited patients up to 60 weeks' postmenstrual age undergoing anaesthesia for surgical or diagnostic procedures from 165 centres in 31 European countries between March 2016 and January 2017. The primary aim was to identify thresholds of pre-determined physiological variables that triggered a medical intervention.

FOXP3 and GATA3 Polymorphisms, Vitamin D3 and Multiple Sclerosis.

Background: Regulatory T cells (Tregs) alterations have been implicated in the pathogenesis of Multiple Sclerosis (MS). Recently, a crucial role of the X-Linked Forkhead Box P3 (FoxP3) for the development and the stability of Tregs has emerged, and FOXP3 gene polymorphisms have been associated with the susceptibility to autoimmune diseases. The expression of Foxp3 in Tregs is regulated by the transcription factor GATA binding-protein 3 (GATA3) and vitamin D.

Catheter-based closure of a large atrial septal defect with inferior rim deficiency using pulmonary vein slide-out assisted implantation technique: a case report.

Background: Transcatheter approach for large and complex atrial septal defects may represent a therapeutic challenge, particularly when the postero-inferior rim is deficient and floppy.

Case Summary: Here, we describe a successful catheter-based closure of a large (>30 mm) secundum atrial septal defect associated with postero-inferior rim deficiency in a 35-year-old female with congestive heart failure using pulmonary vein slide-out assisted implantation technique.

Discussion: Inferior-posterior rim deficiency is a well-known risk factor for device instability or embolization.

Insight the data: Wikipedia's researches and real cases of arboviruses in Italy.

Objectives: The primary aim of this study was to evaluate the temporal correlation between Wikitrends and conventional surveillance data generated for Chikungunya, Dengue, Zika, and West Nile Virus infection reported by bulletin of Italian National Institute of Health (Istituto Superiore di Sanità in italian, ISS).

Study Design: A cross-sectional study design was used.

Methods: The reported cases of Dengue and Chikungunya were selected from July 2015 to December 2019.

Ropeginterferon alfa-2b versus phlebotomy in low-risk patients with polycythaemia vera (Low-PV study): a multicentre, randomised phase 2 trial.

Background: There is no evidence that phlebotomy alone is sufficient to steadily maintain haematocrit on target level in low-risk patients with polycythaemia vera. This study aimed to compare the efficacy and safety of ropeginterferon alfa-2b on top of the standard phlebotomy regimen with phlebotomy alone.

Methods: In 2017, we launched the Low-PV study, a multicentre, open-label, two-arm, parallel-group, investigator-initiated, phase 2 randomised trial with a group-sequential adaptive design.

Blood and body fluids exposure of healthcare workers in a university hospital of Palermo, Italy: a fourteen years long surveillance.

Background: Healthcare workers are habitually in direct contact with patients, possible carriers of infectious diseases and with potentially infectious biological materials; therefore, the implementation of standard precautions and good working practices represent an intervention strongly recommended by the Centers for Disease Control and Prevention, and required by Italian law, for the prevention of professional cut wounds. The study focused on assessing the exposure frequency and factors related to biological injuries among healthcare workers in a teaching hospital in Palermo, Italy.

Methods: We performed a 14-years retrospective descriptive analysis on blood and body fluids exposures in healthcare workers, documented by questionnaires administered at the time of injury and by data collected during the follow-up period.

Effectiveness and safety of glecaprevir/pibrentasvir in chronic hepatitis C patients: Results of the Italian cohort of a post-marketing observational study.

Background And Aims: The MARS post-marketing, observational study evaluates glecaprevir/pibrentasvir in a large population of Italian patients who are infected with HCV.

Patients And Methods: Achievement of SVR12 was the primary endpoint in the overall population and by subpopulations of interest (treatment-naïve and treatment-experienced patients, subjects infected with different HCV genotype/sub-genotype, cirrhotic and non-cirrhotic patients, patients with different severity of fibrosis, patients with an APRI score ≥1, subjects with comorbidities, HIV-coinfected patients, elderly patients and people who use drugs). Safety and quality of life (assessed by SF-36 and Work Productivity and Activity Impairment) were also evaluated.

Changes in life expectancy for cancer patients over time since diagnosis.

The aims of this study were to provide life expectancy (LE) estimates of cancer patients at diagnosis and LE changes over time since diagnosis to describe the impact of cancer during patients' entire lives. Cancer patients' LE was calculated by standard period life table methodology using the relative survival of Italian patients diagnosed in population-based cancer registries in 1985-2011 with follow-up to 2013. Data were smoothed using a polynomial model and years of life lost (YLL) were calculated as the difference between patients' LE and that of the age- and sex-matched general population.

Doubling-Times and Halving-Times May Predict CML Response to Tyrosine Kinase Inhibitors.

In Chronic Myeloid Leukemia (CML), successful treatment requires accurate molecular monitoring to evaluate disease response and provide timely interventions for patients failing to achieve the desired outcomes. We wanted to determine whether measuring mRNA doubling-times (DTs) could distinguish inconsequential rises in the oncogene's expression from resistance to tyrosine kinase inhibitors (TKIs). Thus, we retrospectively examined evolution in 305 chronic-phase CML patients receiving imatinib mesylate (IM) as a first line treatment.

Medication-related osteonecrosis of the jaw in a cancer patient receiving lenvatinib.

Medication-related osteonecrosis of the jaw (MRONJ) is an adverse drug reaction that affects the mandible and maxilla of patients exposed to bone-targeting agents such as anti-resorptive and anti-angiogenic agents. Several MRONJ cases have been reported after dental extractions in patients under treatment with anti-angiogenic agents, including receptor activator of nuclear factor κB ligand (RANKL) inhibitor, anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody, mammalian target of rapamycin (mTOR) inhibitors, and tyrosine kinase inhibitors (TKIs). The aim of this article was to describe an original case of lenvatinib-related osteonecrosis of the jaw in a patient affected by thyroid cancer.

Association between night-time surgery and occurrence of intraoperative adverse events and postoperative pulmonary complications.

Background: The aim of this post hoc analysis of a large cohort study was to evaluate the association between night-time surgery and the occurrence of intraoperative adverse events (AEs) and postoperative pulmonary complications (PPCs).

Methods: LAS VEGAS (Local Assessment of Ventilatory Management During General Anesthesia for Surgery) was a prospective international 1-week study that enrolled adult patients undergoing surgical procedures with general anaesthesia and mechanical ventilation in 146 hospitals across 29 countries. Surgeries were defined as occurring during 'daytime' when induction of anaesthesia was between 8:00 AM and 7:59 PM, and as 'night-time' when induction was between 8:00 PM and 7:59 AM.

Discontinuation of teriflunomide and dimethyl fumarate in a large Italian multicentre population: a 24-month real-world experience.

Background: Teriflunomide (TRF) and Dimethyl fumarate (DMF) are licensed drugs for relapsing-remitting Multiple Sclerosis (RRMS).

Objectives: We aimed to compare the rate and the time to discontinuation among persons with RRMS (pwRRMS), newly treated with TRF and DMF.

Materials And Methods: A retrospective study on prospectively collected data was performed in nine tertiary MS centers, in Italy.

Efficacy of bendamustine and rituximab in splenic marginal zone lymphoma: results from the phase II BRISMA/IELSG36 study.

Splenectomy in addition to immunotherapy with rituximab can provide quick and sometimes durable disease control in patients with splenic marginal zone lymphoma (SMZL). However, systemic chemotherapy is ultimately required in many cases. The BRISMA (Bendamustine-rituximab as first-line treatment of splenic marginal zone lymphoma)/IELSG (International Extranodal Lymphoma Study Group)36 trial is an open-label, single arm phase II study designed by the IELSG in cooperation with the Fondazione Italiana Linfomi and the lymphoma Study Association according to Simon's two-stage method.

Downregulation of miRNA17-92 cluster marks Vγ9Vδ2 T cells from patients with rheumatoid arthritis.

Background: We aimed to evaluate the phenotype, function, and microRNA (miRNA)17-92 cluster expression in Vγ9Vδ2 T-cell subsets and the correlation with immune response in rheumatoid arthritis (RA) patients.

Methods: Peripheral blood from 10 early RA untreated patients and 10 healthy donors (HD) was obtained. Polyclonal Vγ9Vδ2 T-cell lines were generated and analysed by flow cytometry.