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IntroductionThrombotic events in neonates and children represent a rare although severe occurrence in view of the associated risk of mortality and sequelae. Quality evidence is limited in this field, and registry studies provide an essential base for research. The aim of this paper is to present the new Italian Registry of Infantile Thrombosis (RITI), set it into the scene of international thrombosis and stroke registries, and provide some insight on the challenges associated with registry management.MethodsWe present the detailed structure and content of the new RITI registry, a brief overview of its main data, and a reflection on its features, pitfalls and the main challenges related to its management.ResultsThe RITI, initially started in 2007 and officially re-launched in 2017 after structural modifications, is a non-interventional retrospective and prospective registry study collecting data on neonatal and pediatric patients (0–18 years) who experienced a systemic or cerebral thrombotic event in Italy. The RITI is managed by a multidisciplinary team with expertise in pediatric thrombosis, and participation is open to all Italian physicians, on a voluntary basis. The overall aim of the registry is to acquire new evidence to better characterize the population of children with thrombotic events and improve their management and outcome. 48 Italian pediatric and intensive care units are actively involved in the RITI, including 85 medical doctors from 16 Italian regions. A total of 1,001 neonates and children affected by cerebral or systemic thrombosis have been enrolled.DiscussionThe RITI is one of the largest available European registries of neonatal and pediatric thrombosis. National registries like the RITI represent a model for the study of rare conditions based on multidisciplinary and multicenter collaboration, aimed at overcoming the limitations due to small populations of patients, and creating a network of experts for patient referral and continuous education. Moreover, registry studies have a pivotal role in the research on pediatric thrombosis, due to the limited feasibility of high-quality studies. In our experience, the main critical stages, pitfalls and challenges in registry management include adequate registry designing, diffusion, data completeness and quality control.

Alessandra Fantauzzi,1 Marco Floridia,2 Fabrizio Ceci,3 Francesco Cacciatore,4 Vincenzo Vullo,5 Ivano Mezzaroma1 1Department of Clinical Medicine, Sapienza – University of Rome, 2Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità (ISS), 3Department of Cellular Biotechnologies and Hematology, Sapienza University of Rome, Rome, 4U.O. of Cardiac Rehabilitation, Fondazione Salvatore Maugeri, IRCCS, Istituto di Telese Terme, Benevento, 5Department of Public Health and Infectious Diseases, Sapienza – University of Rome, Rome, Italy Objectives: With the development of effective treatments and the resulting increase in life expectancy, bone mineral density (BMD) alteration has emerged as an important comorbidity in human immunodeficiency virus type-1 (HIV-1)-infected individuals. The potential contributors to the pathogenesis of osteopenia/osteoporosis include a higher prevalence of risk factors, combined antiretroviral therapy (cART)-exposure, HIV-1 itself and chronic immune activation/inflammation. Dual-energy X-ray absorptiometry (DXA) is the “gold standard” technique for assessing bone status in HIV-1 population. Methods: We conducted a cross-sectional study to investigate bone mineral status in a group of 158 HIV-1-infected subjects. The primary endpoint was the feasibility of calcaneal quantitative ultrasound (QUS) as a screening tool for BMD. All subjects were receiving stable cART and were virologically suppressed (HIV-RNA

Alessandra Fantauzzi,1 Ombretta Turriziani,2 Ivano Mezzaroma11Department of Clinical Medicine, 2Department of Molecular Medicine, Sapienza, University of Rome, Rome, ItalyAbstract: The viral integrase enzyme has recently emerged as a primary alternative target to block HIV-1 replication, and integrase inhibitors are considered a pivotal new class of antiretroviral drugs. Dolutegravir is an investigational next-generation integrase inhibitor showing some novel and intriguing characteristics, ie, it has a favorable pharmacokinetic profile with a prolonged intracellular half-life, rendering feasible once-daily dosing without the need for ritonavir boosting and without regard to meals. Moreover, dolutegravir is primarily metabolized via uridine diphosphate glucuronosyltranferase 1A1, with a minor component of the cytochrome P450 3A4 isoform, thereby limiting drug–drug interactions. Furthermore, its metabolic profile enables coadministration with most of the other available antiretroviral agents without dose adjustment. Recent findings also demonstrate that dolutegravir has significant activity against HIV-1 isolates with resistance mutations associated with raltegravir and/or elvitegravir. The attributes of once-daily administration and the potential to treat integrase inhibitor-resistant viruses make dolutegravir an interesting and promising investigational drug. In this review, the main concerns about the efficacy and safety of dolutegravir as well as its resistance profile are explored by analysis of currently available data from preclinical and clinical studies.Keywords: antiretroviral drugs, HIV-1 integrase, integrase inhibitors, dolutegravir, once daily

Abstract Background The optimal therapeutic strategies for patients presenting with advanced disease at HIV-1 diagnosis are as yet incompletely defined. Methods All patients presenting at two outpatient clinics in 2000-2009 with an AIDS-defining clinical condition or a CD4+ T cell count < 200/μL at HIV-1 diagnosis were analyzed for the presence of combined immunovirological response, defined by the concomitant presence of an absolute number of CD4+ T cells > 200 cells/μL and a plasma HIV-1 RNA copy number < 50/mL after 12 months of HAART. Results Among 102 evaluable patients, first-line regimens were protease inhibitors [PI]-based in 78 cases (77%) and efavirenz-based in 24 cases (23%). The overall response rate was 65% (95% CI: 55-74), with no differences by gender, age, nationality, route of transmission, hepatitis virus coinfections, presence of AIDS-defining clinical events, baseline HIV-1 viral load, or type of regimen (response rates with PI-based and efavirenz-based therapy: 63% and 71%, respectively, p = 0.474). Response rate was significantly better with higher baseline CD4+ T cell counts (78% with CD4+ ≥ 100/μL, compared to 50% with CD4+ < 100/μL; odds ratio: 3.5; 95% CI: 1.49-8.23, p = 0.003). Median time on first-line antiretroviral therapy was 24 months (interquartile range: 12-48). Switch to a second line treatment occurred in 57% of patients, mainly for simplification (57%), and was significantly more common with PI-based regimens [adjusted hazard ratios (AHR) with respect to efavirenz-based regimens: 3.88 for unboosted PIs (95% CI: 1.40-10.7, p = 0.009) and 4.21 for ritonavir-boosted PI (95%CI 1.7-10.4, p = 0.002)] and in older subjects (≥ 50 years) (AHR: 1.83; 95% CI: 1.02-3.31, p = 0.044). Overall mortality was low (3% after a median follow up of 48 months). Conclusions Our data indicate that a favorable immunovirological response is possible in the majority of naive patients presenting at HIV-1 diagnosis with AIDS or low CD4+ T cell counts, and confirm that starting HAART with a more compromised immune system may be associated with a delayed and sometimes partial immune recovery. Simpler regimens may be preferable in this particular population.

Abstract In HIV-1 infected patients, increase of liver enzymes may be mainly due to viral coinfections, alcohol intake, hepatotoxic drugs or autoimmune diseases. Three cases of aminotransferase elevation occurred during a phase of uncontrolled viral replication combined with a severe immunodeficiency and resolved by an effective HAART are described, focusing on the etio-pathogenetic role possibly played by HIV-1 infection.

Abstract Background Breastfeeding has a major impact on CMV epidemiology. Postnatal CMV reactivation's incidence during lactation is nearby the maternal seroprevalence. Although perinatal CMV infection has practically no consequences in term newborn, it may cause, in some cases, a severe symptomatic disease in preterm newborns. The aims of the present study are to evaluate the rate and clinical expression of CMV infection breast milk transmitted in preterm infants and to check the safety of the freezing treated breast milk. Methods The study included fifty-seven preterm infants and their CMV seropositive mothers. Fresh breast milk samples have been collected from 1st to 9th postpartum week. Both fresh breast milk and 72, 96, 120 hours frozen samples have been examined, checking the presence of CMV; urine samples have been tested too. Results 70.2% of tested mothers showed reactivation of the infection, and CMV-positive breast milk during the six weeks postpartum has been found. However, only one infant was infected by CMV, developing hepatic affection concomitantly with a multi-system involvement, as shown CMV DNA detection in urine, saliva, blood, gastric aspirate, and stools. Conclusion Freezing breast milk at -20°C and pasteurization may respectively reduce or eliminate the viral load.

Purpose: This study aims, first of all, to analyze the extent to which Italian higher education institutions declare their mission statements in their official documents; then, to examine their content; and finally, to investigate whether mission statements include considerations on sustainability dimensions. Design/methodology/approach: After a theoretical background on the new strategic approach adopted by higher education institutions and the related disclosure of their mission statements, the study deepens their sustainable perspective presenting the concepts of social engagement and knowledge transfer from a literary point of view. Then, a documentary analysis on the content of Italian universities' official mission declarations will be conducted, to understand the role they play in society, by individuating their actual interest in sustainable dimensions. Findings: Findings suggest that 36% of the 98 Italian universities state their engagement in societal issues, but only 3 of them mention sustainability targets in their mission declarations. Research limitations/implications: The study is limited, exclusively based on what higher education institutions share and, in terms of future perspective, the aim can be to investigate further official documents, especially for what concerns sustainability reports. Practical implications: Practical implications regard the denounce of weak attention paid by Italian universities to sustainability, with the aim to foster them to increase connections with the external world, aware of the centrality of their role within society. Originality/value: In a context that is not yet completely investigated, the originality of the paper regards the intent to study the sustainable propensity that characterizes the Italian higher education system.

Our study aims to evaluate clinical predictors of menstrual cycle disorders in female athletes who compete in running disciplines. This is a prospective observational study. Women were recruited between January and May 2022. Fifty-three patients were enrolled and completed a questionnaire about menstrual cycle, physical activity, and food habit characteristics. Of the women in our population, 39.6% had menstrual irregularities and reported a significantly higher number of kilometers run per week (67 vs. 35, p:0.02). The number of kilometers run per week was associated with menstrual irregularities (for 10 km, OR 1.35; IC95% 1.05–1.73; p: 0.02) after adjusting for BMI, age, level of sport and caloric intake. The variable of "km run per week" appeared as a diagnostic indicator of irregular menstrual cycle with statistical significance (AUC ROC curve 0.71, IC95% 0.54–0.86, p-value=0.01) and the cut-off of 65 km run per week is a good indicator of the presence of irregular menstrual cycle (sensitivity (SE) and specificity (SP) of 55% and 81.48%). Menstrual cycle disorders are very frequent in female athletes, and the variable of km run per week may play a role in screening endurance athletes at high risk for these disorders. [ABSTRACT FROM AUTHOR]

The physico-chemical investigation of superparamagnetic MCM41 like materials prepared by the novel combination of high energy ball milling and a liquid crystal templating method is presented. Structural, morphological, textural, thermal, and preliminary magnetic characterization demonstrated the successful combination of the two synthesis techniques, avoiding the problems associated with the current methods used for the preparation of magnetic ordered mesoporous silica. MCM41 like materials with high specific surface area values (625-720 m2 g-1) and high mesopore volumes in the range 1-0.7 cm³ g-1 were obtained. The ordered mesoporous structure and accessible pores were maintained after the inclusion of increasing amounts of the magnetic component in the silica structure. All the samples showed superparamagnetic behaviour. [ABSTRACT FROM AUTHOR]

X-ray photoelectron spectroscopy (XPS) and angle-resolved XPS (ARXPS) characterization of surface layers resulting from the functionalization of polymers such as polyvinylchloride (PVC) modified with 3(mercaptopropyl)-trimethoxysilane (MPTMS) and (3-aminopropyl) triethoxysilane (APTES) is challenging due to the overlap in signals, deriving both from the substrate and the functionalized layers. In this work, a freshly cleaved, ideally flat gold surface was used as carbon-free model substrate functionalized with MPTMS and subsequently grafted with APTES. Avoiding the overlap of signals from carbon atoms present in the substrate, the signals in the C1s, O1s, Si2p, S2p and N1s high-resolution spectra could be assigned to the MPTMS/APTES functionalized layer only and the curve-fitting parameters could be determined. Quantitative analysis was in very good agreement with the expected stoichiometry of the functionalized layer, confirming the adopted curve-fitting procedure. In addition, it was found that one molecule of APTES grafted two MPTMS via silane groups. ARXPS allowed for determining the thickness of the functionalized layers: MPTMS thickness was found to be 0.5 (0.2) nm, whereas MPTMS + APTES thickness 1.0 (0.2) nm was in good agreement with Avogadro model calculations. This approach can be considered a powerful tool for characterizing functionalized surfaces of more complex systems by XPS. [ABSTRACT FROM AUTHOR]