3 research outputs found

    Adempimenti ed obblighi che ogni app deve rispettare

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    L'obiettivo di questa tesi è quello di esaminare il ruolo del GDPR nella protezione dei dati personali, con particolare attenzione alla sua applicazione nello sviluppo di un'applicazione, e di analizzare l'emergenza sanitaria del COVID-19 e il ruolo dell'app Immuni nel rispetto della privacy e nella protezione dei dati personali. Il primo capitolo descrive il GDPR e le sue definizioni fondamentali, nonché i principi applicabili al trattamento dei dati personali. Inoltre, vengono esaminati i soggetti del trattamento dei dati personali e le condizioni di liceità del trattamento. Nel secondo capitolo, viene analizzato il processo di sviluppo di un'applicazione e le leggi applicabili alla protezione dei diritti di proprietà intellettuale e sulla concorrenza e il mercato. Infine, il terzo capitolo si concentra sull'emergenza sanitaria del COVID-19 e l'utilizzo dell'app Immuni, esaminando le implicazioni per la privacy e la protezione dei dati personali. L'elaborato evidenzia l'importanza del rispetto della privacy e della protezione dei dati personali nella società digitale attuale e come il GDPR possa contribuire a garantirli. Inoltre, fornisce linee guida per lo sviluppo di applicazioni mobili che rispettino le leggi e le normative applicabili, tra cui il GDPR, la protezione dei diritti di proprietà intellettuale e le norme sulla concorrenza e il mercato

    Efficacy of ketamine in refractory convulsive status epilepticus in children: A protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01)

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    Introduction: Status epilepticus (SE) is a lifethreatening neurological emergency. SE lasting longer than 120 min and not responding to first-line and second-line antiepileptic drugs is defined as 'refractory' (RCSE) and requires intensive care unit treatment. There is currently neither evidence nor consensus to guide either the optimal choice of therapy or treatment goals for RCSE, which is generally treated with coma induction using conventional anaesthetics (high dose midazolam, thiopental and/or propofol). Increasing evidence indicates that ketamine (KE), a strong N-methyl-D-aspartate glutamate receptor antagonist, may be effective in treating RCSE. We hypothesised that intravenous KE is more efficacious and safer than conventional anaesthetics in treating RCSE. Methods and analysis: A multicentre, randomised, controlled, open-label, non-profit, sequentially designed study will be conducted to assess the efficacy of KE compared with conventional anaesthetics in the treatment of RCSE in children. 10 Italian centres/ hospitals are involved in enrolling 57 patients aged 1 month to 18 years with RCSE. Primary outcome is the resolution of SE up to 24 hours after withdrawal of therapy and is updated for each patient treated according to the sequential method. Ethics and dissemination: The study received ethical approval from the Tuscan Paediatric Ethics Committee (12/2015). The results of this study will be published in peer-reviewed journals and presented at international conferences

    Comparative efficacy of antiepileptic drugs in children and adolescents: A network meta-analysis

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    Objective: To estimate the comparative efficacy among antiepileptic drugs in the pediatric population (0-18 years). Methods: Using the Embase and MEDLINE databases, we updated to February 2017 the search strategy of the National Institute for Health and Care Excellence guidelines for epilepsy. We only included randomized clinical trials conducted in children and mixed-age populations. According to the PRISMA network meta-analysis guideline, the study-level quality assessment was made with the Cochrane risk-of-bias tool. Three investigators independently selected articles. The efficacy outcome was considered to be seizure freedom or â\u89¥50% seizure reduction. Results: We selected 46 randomized clinical trials. A total of 5652 individuals were randomized to 22 antiepileptic drugs and placebo. The point estimates of carbamazepine and lamotrigine efficacy showed their superiority with respect to all comparator antiepileptic drugs for the treatment of newly diagnosed focal epilepsy. In refractory focal epilepsy, levetiracetam (odds ratio [OR] = 3.3, 95% credible interval [CrI] = 1.3-7.6) and perampanel (OR = 2.5, 95% CrI = 1.1-5.8) were more effective compared to placebo. Ethosuximide and valproic acid were both superior to lamotrigine against absence seizures. The OR point estimate showed the superiority of adrenocorticotropic hormone over all comparators in infantile spasms. A wide heterogeneity in the length of follow-up was observed among the studies. Significance: This network meta-analysis suggests that the quality of studies should be improved through the use of comparative designs, relevant outcomes, appropriate follow-up length, and more reliable inclusion criteria
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