Search

Right-to-left shunt may be a cause of paradoxical embolization (and cryptogenic cerebral ischemic events). Patent foramen ovale and pulmonary arterio-venous malformations are the most common cause of paradoxical embolization; however, some rare cardiovascular lesions may cause a right-to-left shunt with consequent paradoxical embolization. We describe a case of a young child with superior sinus venosus atrial septal defect who underwent surgical closure and developed a cryptogenic cerebral ischemic attack due to a rare cause of paradoxical embolization, during a long-term follow-up. This case report cautions us to consider some rare causes of parodixal embolization such as systemic-pulmonary venous connections. The diagnosis should be always suspected in patients with paradoxical embolization without a patent foramen ovale and/or arterio-venous pulmonary malformations. [ABSTRACT FROM AUTHOR]

The problem of executing machine learning algorithms over data while complying with data privacy is highly relevant in many application areas, including medicine in general and Precision Medicine in particular. In this paper, an innovative framework for Federated Learning is proposed that allows performing machine learning and effectively tackling the issue of data privacy while taking a step towards security during communication. Unlike the standard federated approaches where models should travel on the communication networks and would be subject to possible cyberattacks, the models proposed by our framework do not need to travel, thus moving in the direction of security improvement. Another very appealing feature is that it can be used with any machine learning algorithm provided that, during the learning phase, the model updating does not depend on the input data. To show its effectiveness, the learning process is here accomplished by an Evolutionary Algorithm, namely Grammatical Evolution, thus also obtaining explicit knowledge that can be provided to the domain experts to justify the decisions made. As a test case, glucose values prediction for a number of patients with type 1 diabetes is considered and is tackled as a classification problem, the goal being to predict for any future value a possible range. Finally, a comparison of the performance of the proposed framework is performed against that of a non-Federated Learning approach. [Display omitted] Model-Free-Communication Federated Learning framework: the performance communication step. The top pane of the figure sketches the dispatch from the clients to the server of the solution's local performance ( ϕ i (M) represents the performance value of the current solution M computed on the local data present on the i th client), while the bottom one traces the dispatch from the server to the clients of the solution's global performance. • An innovative Model-Free-Communication Federated Learning framework is proposed. • It may improve security in communication because models do not travel on the network. • This framework is applied to Precision Medicine by using Grammatical Evolution. • As a test case, future glucose values prediction is faced for T1DM diabetic subjects. • The global model found allows effectively predicting over twelve diabetes patients. [ABSTRACT FROM AUTHOR]

The dynamical reconfiguration of photovoltaic panels is a useful approach for fighting the detrimental effects of mismatching on their power production. The practical implementation of the method has been recently optimized by means of efficient and reliable relays. However, two problems remain still open. The first is to determine the optimal electrical connection among the panels that ensures the maximum power produced at the actual irradiance conditions, while the latter is to constrain the computation time of such optimal configuration to fit the need of real time applications. We present an evolutionary approach to the first problem. It is designed for allowing a straightforward porting to an embedded system and it is aimed at reconfiguring photovoltaic panels, thus not modules like some other approaches do in literature. Simulation results confirm the reliability and convergence capabilities of the proposed method and encourage further work for the adoption of the algorithm in real time applications. The problem of minimizing the computation time is also addressed. [ABSTRACT FROM AUTHOR]

The purpose of this paper is to conduct a systematic review of cyberbullying intervention programs that are either in current practice and/or have been well documented. There are negative effects associated with cyberbullying including, poor academic, social, and mental health outcomes. Consequently, there is a need to develop evidence-based interventions. Critical content and evaluation elements of traditional bullying interventions provided a framework, due to the limited evidence on effective features for addressing cyberbullying. The review is based on a set of criteria for traditional bullying by Craig, Pepler, and Shelley (2004), which emphasizes scientific merit and ease of implementation. Results suggest that most studies are lacking in scientific merit, with most studies meeting less than half of the criteria. The average ease of implementation score was higher than that of scientific merit, however only 3 programs provided maintenance after implementation. Recommendations are made for best practices for cyberbullying interventions. [ABSTRACT FROM AUTHOR]

Abstract: Young children are at increased risk for influenza infections and related complications. The protection offered to children by conventional trivalent inactivated influenza vaccines (TIV) is suboptimal, due to poor immunogenicity and a higher exposure to infection and complications in this age group, particularly from influenza B strains. In this dose-ranging, factorial design trial, we report the safety and immunogenicity of different combinations of adjuvanted (ATIV) and non-adjuvanted trivalent (TIV) and quadrivalent (QIV) influenza vaccines in 480 healthy children 6 to <36 months of age. The results show that the second B strain added to TIV was immunogenic and did not affect immunogenicity of the other strains. The addition of the MF59® adjuvant promoted robust immune responses with notable elevations in antibodies observed even after one dose. A dose–response relationship was observed between the antibody response and MF59 adjuvant. No patterns in safety and tolerability emerged with different adjuvant and antigen doses nor with the addition of a second B strain. MF59-adjuvanted QIV offers potential advantages to young children. [Copyright &y& Elsevier]

Abstract: We reviewed the safety of MF59-adjuvanted versus non-adjuvanted influenza vaccines in children and adolescents (aged 6 months–18 years) in an integrated analysis of all pediatric trials evaluating MF59-containing influenza vaccines completed to date (5 trials). In the MF59-adjuvanted group (n =1181) versus the non-adjuvanted group (n =545) there was no increase in the incidence of unsolicited adverse events and serious adverse events. As expected, solicited local or systemic reactions occurred more frequently in MF59-adjuvanted subjects; however, a majority of reactions were mild and transient. These data support the safety of MF59-adjuvanted influenza vaccines in the pediatric population. [ABSTRACT FROM AUTHOR]

This paper presents a learning system that uses genetic programming as a tool for automatically inferring the set of classification rules to be used during a preclassification stage by a hierarchical handwritten character recognition system. Starting from a structural description of the character shape, the aim of the learning system is that of producing a set of classification rules able to capture the similarities among those shapes, independently of whether they represent characters belonging to the same class or to different ones. In particular, the paper illustrates the structure of the classification rules, the grammar used to generate them and the genetic operators devised to manipulate the set of rules, as well as the fitness function used to drive the inference process. The experimental results obtained by using a set of 10,000 digits extracted from the NIST database show that the proposed preclassification is efficient and accurate, because it provides at most 6 classes for more than 87% of the samples, and the error rate almost equals the intrinsic confusion found in the data set. [Copyright &y& Elsevier]

In this paper we propose a method for evaluating the performance of an evolutionary learning system aimed at producing the optimal set of prototypes to be used by a handwriting recognition system. The trade-off between generalization and specialization embedded into any learning process is managed by iteratively estimating both consistency and completeness of the prototypes, and by using such an estimate for tuning the learning parameters in order to achieve the best performance with the smallest set of prototypes. Such estimation is based on a characterization of the behavior of the learning system, and is accomplished by means of three performance indices. Both the characterization and the indices do not depend on either the system implementation or the application, and therefore allow for a truly black–box approach to the performance evaluation of any evolutionary learning system. [Copyright &y& Elsevier]

A three-step approach to the early development of adjuvanted vaccine candidates is proposed, the goal of which is to allow ample space for exploratory and hypothesis-generating human experiments and to select dose(s) and dosing schedule(s) to bring into full development. Although the proposed approach is more extensive than the traditional early development program, the authors suggest that by addressing key questions upfront the overall time, size and cost of development will be reduced and the probability of public health advancement enhanced. The immunogenicity end-points chosen for early development should be critically selected: an established immunological parameter with a well characterized assay should be selected as primary end-point for dose and schedule finding; exploratory information-rich end-points should be limited in number and based on pre-defined hypothesis generating plans, including system biology and pathway analyses. Building a pharmacodynamic profile is an important aspect of early development: to this end, multiple early (within 24 h) and late (up to one year) sampling is necessary, which can be accomplished by sampling subgroups of subjects at different time points. In most cases the final target population, even if vulnerable, should be considered for inclusion in early development. In order to obtain the multiple formulations necessary for the dose and schedule finding, “bed-side mixing” of various components of the vaccine is often necessary: this is a complex and underestimated area that deserves serious research and logistical support. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The 2009-2010 A/H1N1 pandemic provided a unique setting to study the safety of MF59-adjuvanted vaccination in pregnancy. STUDY DESIGN: This was an observational cohort study of the safety of an MF59-adjuvanted A/H1N1 vaccine (Focetria) conducted among 4508 pregnant women (2295 vaccinated vs 2213 unvaccinated), with 3 month follow-up of neonates. RESULTS: No maternal deaths or abortions occurred among the vaccinated women. No differences between the vaccinated and unvaccinated cohorts were observed for gestational diabetes, preeclampsia, stillbirth, low birthweight, neonatal deaths, or congenital malformations. The risk of premature birth was significantly decreased among the vaccinated women (adjusted proportional hazard, 0.69; 95% confidence interval, 0.51-0.92). No differences were observed in rates of congenital malformations after vaccination in the first (2.1%), second (2.7%), or third (2.1%) trimesters. CONCLUSION: There was no evidence of a safety risk for MF59-adjuvanted A/H1N1 vaccination in pregnant women; protection was observed against premature birth. [ABSTRACT FROM AUTHOR]

Objectives This study was designed to identify the optimal dose of an MF59 ® -adjuvanted, monovalent, A/H1N1 influenza vaccine in healthy paediatric subjects. Methods Subjects aged 3–8 years ( n = 194) and 9–17 years ( n = 160) were randomized to receive two primary doses of A/H1N1 vaccine containing either 3.75 μg antigen with half a standard dose of MF59 adjuvant, 7.5 μg antigen with a full dose of MF59, or (children 3–8 years only), a non-adjuvanted 15 μg formulation. A booster dose of MF59-adjuvanted seasonal influenza vaccine including homologous A/H1N1 strain was given one year after priming. Immunogenicity was assessed by haemagglutination inhibition (HI) and microneutralization assays. Vaccine safety was assessed throughout the study (up to 18 months). Results A single priming dose of either MF59-adjuvanted formulation was sufficient to meet the European licensure criteria for pandemic influenza vaccines (HI titres ≥1:40 > 70%; seroconversion > 40%; and GMR > 2.5). Two non-adjuvanted vaccine doses were required to meet the same licensure criteria. After first and second doses, percentage of subjects with HI titres ≥1:40 were between 97% and 100% in the adjuvanted vaccine groups compared with 68% and 91% in the non-adjuvanted group, respectively. Postvaccination seroconversion rates ranged from 91% to 98% in adjuvanted groups and were 68% (first dose) and 98% (second dose) in the non-adjuvanted group. HI titres ≥1:330 after primary doses were achieved in 69% to 90% in adjuvanted groups compared with 41% in the non-adjuvanted group. Long-term antibody persistence after priming and a robust antibody response to booster immunization were observed in all vaccination groups. All A/H1N1 vaccine formulations were generally well tolerated. No vaccine-related serious adverse events occurred, and no subjects were withdrawn from the study due to an adverse event. Conclusions An MF59-adjuvanted influenza vaccine containing 3.75 μg of A/H1N1 antigen was well tolerated and sufficiently immunogenic to meet all the European licensure criteria after a single dose in healthy children 3–17 years old. [ABSTRACT FROM AUTHOR]

Abstract: Background: Adding adjuvants such as MF59® to influenza vaccines can enhance the immune response. This analysis evaluated the safety profile of MF59-adjuvanted [(+)MF59] compared with non-adjuvanted [(−)MF59] vaccines in a large clinical database. Methods: Safety data were pooled from 64 clinical trials involving (+)MF59 seasonal and pandemic influenza vaccines. Safety outcomes were analysed in the overall population and in subjects aged ≥65 years, in all clinical trials and in controlled trials only. Findings: Data from 20,447 (+)MF59 and 7526 (−)MF59 subjects were analysed. Overall, (+)MF59 subjects had lower risks than (−)MF59 subjects of experiencing any unsolicited adverse event (AE) (26.8% vs 39.2%; adjusted risk ratio [ARR] 0.65; 95% CI 0.60–0.70), cardiovascular AEs (1.9% vs 5.6%; ARR 0.44; 95% CI 0.35–0.55), new onset chronic diseases (1.3% vs 1.9%; ARR 0.71; 95% CI 0.57–0.87) and death (0.8% vs 1.2%; ARR 0.67; 95% CI 0.51–0.87). Few AEs of potential autoimmune origin were reported: 0.71 and 0.67 per 1000 with (+)MF59 and (−)MF59, respectively. As expected, (+)MF59 subjects had a higher risk of solicited local or systemic reactions within 3 days of vaccination (58.5% vs 46.9%, weighted RR 1.34; 95% CI 1.28–1.40). Safety outcomes were consistent between total and elderly populations, and between all trials and controlled trials, although statistical significance was lost for some of the outcomes in the subgroups. Interpretation: This large-scale analysis supports the good safety profile of (+)MF59 seasonal and pandemic influenza vaccines and suggests a clinical benefit over (−)MF59 influenza vaccines. [Copyright &y& Elsevier]

BACKGROUND: Inhaled short-acting beta(2)-adrenoceptor agonists are the most commonly used treatment for the prevention of exercise-induced bronchoconstriction (EIB). Formoterol, a long-acting beta(2)-adrenoceptor agonist, has been demonstrated to provide protection from EIB, although the onset and duration of this protection have not been defined. OBJECTIVE: The purpose of this study was to determine the onset and duration of the protective effect of a single dose of inhaled formoterol powder against EIB, comparing them with the effect of a single dose of placebo and albuterol administered via metered-dose inhaler (MDI). METHODS: In this double-dummy, 4-way crossover study, patients received single doses of formoterol (12 and 24 microg) via a powder inhaler, albuterol by MDI (180 microg), and placebo. Exercise challenge tests (ECTs) were conducted at 15 minutes and at 4, 8, and 12 hours postdose. Pulmonary function studies (forced expiratory volume in 1 second [FEV(1)] and peak expiratory flow rate) were performed before and after each exercise challenge. RESULTS: Twenty adolescent and adult patients (mean age, 23.8 years; range, 13-41 years; 9 male, 11 female) with asthma were enrolled in the study, and 17 completed all 4 treatment sequences. Compared with placebo, both doses of formoterol produced significantly greater inhibition of FEV(1) decreases at all time points (P < 0.01). There were no significant differences in efficacy measures between the 2 formoterol doses throughout the study. The exercise-induced decrease in FEV(1) after albuterol treatment was significantly reduced compared with placebo only at 15 minutes after dosing (P < 0.05). Formoterol and albuterol exhibited a similar rapid onset of action (<15 minutes), but formoterol continued to protect patients against EIB for at least 12 hours (P < 0.01), whereas albuterol was no longer clinically effective by the 4-hour ECT. CONCLUSIONS: Formoterol and albuterol, given as single-dose inhalations, both provided protection from EIB within 15 minutes in this group of patients. The bronchoprotection afforded by formoterol lasted up to 12 hours, whereas that of albuterol was no longer significant by 4 hours. [ABSTRACT FROM AUTHOR]