30 research outputs found

    Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trial.

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    BACKGROUND Major depressive disorder (MDD) is prevalent and disabling among older adults. Standing on its tolerability profile, vortioxetine might be a promising alternative to selective serotonin reuptake inhibitors (SSRIs) in such a vulnerable population. METHODS We conducted a randomised, assessor- and statistician-blinded, superiority trial including older adults with MDD. The study was conducted between 02/02/2019 and 02/22/2023 in 11 Italian Psychiatric Services. Participants were randomised to vortioxetine or one of the SSRIs, selected according to common practice. Treatment discontinuation due to adverse events after six months was the primary outcome, for which we aimed to detect a 12% difference in favour of vortioxetine. The study was registered in the online repository clinicaltrials.gov (NCT03779789). FINDINGS The intention-to-treat population included 179 individuals randomised to vortioxetine and 178 to SSRIs. Mean age was 73.7 years (standard deviation 6.1), and 264 participants (69%) were female. Of those on vortioxetine, 78 (44%) discontinued the treatment due to adverse events at six months, compared to 59 (33%) of those on SSRIs (odds ratio 1.56; 95% confidence interval 1.01-2.39). Adjusted and per-protocol analyses confirmed point estimates in favour of SSRIs, but without a significant difference. With the exception of the unadjusted survival analysis showing SSRIs to outperform vortioxetine, secondary outcomes provided results consistent with a lack of substantial safety and tolerability differences between the two arms. Overall, no significant differences emerged in terms of response rates, depressive symptoms and quality of life, while SSRIs outperformed vortioxetine in terms of cognitive performance. INTERPRETATION As opposed to what was previously hypothesised, vortioxetine did not show a better tolerability profile compared to SSRIs in older adults with MDD in this study. Additionally, hypothetical advantages of vortioxetine on depression-related cognitive symptoms might be questioned. The study's statistical power and highly pragmatic design allow for generalisability to real-world practice. FUNDING The study was funded by the Italian Medicines Agency within the "2016 Call for Independent Drug Research"

    Enhanced Recovery After Surgery e assistenza infermieristica in urologia: utopia o futura pietra miliare? Una revisione della letteratura

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    BACKGROUND: Enhanced Recovery After Surgery (ERAS) is a multidisciplinary program of evidence-based interventions that minimizes physical response to surgical stress, allows patients to achieve better outcomes, early and safe discharge, and reduces costs. Despite the presence of evidence on the usefulness of the ERAS program in major surgery, the implementation of this multidisciplinary pathway has not yet achieved consensus in urologic surgery. AIMS: The purpose of this paper is to analyze the ERAS elements implemented in urological surgery for each stage of the surgical process, evaluate their outcomes, and investigate nursing perspectives. METHODS: After identifying the scope and research question, the PIO (Population, Intervention, Outcome) was formulated. In August and September 2022, the literature search was conducted by searching the main biomedical databases: PubMed, Cinahl, Embase. RESULTS: Fourteen papers were included. 1 qualitative design and 13 quantitative design. Several topics areas were identified, divided into the different stages of the operative process. CONCLUSIONS: The contributions analyzed in this paper add to the increasing number of evidence supporting the value of ERAS to improve outcomes in the population undergoing urologic surgery, with particular reference to patients undergoing radical cystectomy, which is a highly demolitive procedure.BACKGROUND: Enhanced Recovery After Surgery (ERAS) è un programma multidisciplinare volto a ridurre al minimo la risposta del corpo allo stress chirurgico, consente agli assistiti di ottenere outcome migliori, dimissioni precoci e sicure nonché la riduzione dei costi. Nonostante la presenza di numerose evidenze clinico-scientifiche in letteratura sull'utilità del programma ERAS nella chirurgia maggiore, l'implementazione di questo percorso multidisciplinare non ha ancora raggiunto consenso unanime nella chirurgia urologica. OBIETTIVI: Obiettivo del presente lavoro è analizzare per ogni fase del processo chirurgico gli item ERAS messi in atto in chirurgia urologica, valutarne gli esiti e indagare le prospettive infermieristiche. METODI: Dopo aver identificato l’ambito e il quesito di ricerca è stato formulato il PIO (Popolazione, Intervento, Esito). Nei mesi di agosto e settembre 2022 è stata condotta la ricerca bibliografica attraverso la consultazione delle principali banche dati biomediche: PubMed, Cinahl, Embase. RISULTATI: Sono stati ritenuti validi 14 articoli per la stesura dell’elaborato. 1 con disegno qualitativo e 13 con disegno quantitativo. Sono state identificate diverse aree tematiche, idealmente suddivise nelle diverse fasi del processo operatorio.  CONCLUSIONI: I contributi analizzati in questo elaborato assumono un significato clinico importante, aggiungendosi al crescente numero di evidenze che supportano il valore di ERAS negli sforzi messi in atto per migliorare gli esiti clinici nella popolazione sottoposta a chirurgia urologica, con particolare riferimento ai pazienti sottoposti a cistectomia radicale, procedura altamente demolitiva

    A practical identification procedure for unmanned underwater vehicles - From modeling to experiments

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    The need of defining suitable dynamical models for Unmanned Underwater Vehicles (UUVs) is of absolute importance for the sake of a precise motion estimation (needed due the slow rate and low precision measurement usually provided by acoustic devices) and guidance & control system design, where regulation scheme and parameter setting have to be defined and evaluated on the basis of a reliable dynamical model

    Addressing Cetacean–Fishery Interactions to Inform a Deep-Sea Ecosystem-Based Management in the Gulf of Taranto (Northern Ionian Sea, Central Mediterranean Sea)

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    Understanding of cetaceans’ trophic role and the quantification of their impacts on the food web is a critical task, especially when data on their prey are linked to deep-sea ecosystems, which are often exposed to excessive exploitation of fishery resources due to poor management. This aspect represents one of the major issues in marine resource management, and trade-offs are needed to simultaneously support the conservation of cetaceans and their irreplaceable ecological role, together with sustainable fishing yield. In that regard, food web models can represent useful tools to support decision-making processes according to an ecosystem-based management (EBM) approach. This study provides a focus on the feeding activity occurrence and the trophic interactions between odontocetes and the fishery in the marine food web of the Gulf of Taranto (Northern Ionian Sea, Central Mediterranean Sea), by zooming in on cetaceans’ prey of commercial interest. In particular, the quantification of trophic impacts is estimated using a food web mass-balance model that integrates information on the bathymetric displacement of both cetaceans’ prey and fishing activity. The results are discussed from a management perspective to guide future research and knowledge enhancement activities as well as support the implementation of an EBM approach

    Clinical and audiological follow up of a family with the 8363G > A mutation in the mitochondrial DNA

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    Hearing loss is relatively common in mtDNA-related disorders. While auditory function has been assessed folly in the syndrome of mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes, few studies have investigated the degree of progressive hearing deficit in individuals bearing other mtDNA mutations. We performed a 4-year clinical and audiological follow LIP in a family carrying the 8363G > A mutation in the mitochondrial transfer ribonucleic acid lysine (tRNA(Lys)) gone who displayed a progressive neuro-muscular disease. In addition to Pore tone audiometry, we considered distortion products of otoacoustic emissions, a sensitive indicator of cochlear dysfunction, as well as brainstem auditory evoked responses. A generalized increase in the auditory threshold at follow LIP, indicating a cochlear impairment in three cases, was noted. Distortion products Of otoacoustic emissions may reveal sub-clinical cochlear dysfunction, even in oligosymptomatic patients. A complete and periodical assessment of the hearing function Should be encouraged in asymptomatic relatives of patients carrying the tRNA(Lys), 8363G > A Mutation. (C) 2009 Elsevier B.V. All rights reserved

    Prion strain characterization of a novel subtype of Creutzfeldt-Jakob disease

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    In 2007, we reported a patient with an atypical form of Creutzfeldt-Jakob disease (CJD), heterozygous for methionine-valine (MV) at codon 129, who showed a novel pathological prion protein (PrP(TSE)) conformation with an atypical glycoform (AG) profile and an intraneuronal PrP deposition. In the present study, we further characterized the conformational properties of this pathological prion protein (PrP(TSE) MV(AG)) showing that PrP(TSE) MV(AG) is composed by multiple conformers with biochemical properties distinct from PrP(TSE) type 1 and type 2 of MV sporadic CJD (sCJD). Experimental transmission of CJD-MV(AG) to bank voles and gene-targeted transgenic mice carrying the human prion protein gene (TgHu) showed unique transmission rates, survival times, neuropathological changes, PrP(TSE) deposition patterns and PrP(TSE) glycotypes that are distinct from sCJD-MV1 and sCJD-MV2. These biochemical and experimental data suggest the presence of a novel prion strain in CJD-MV(AG)IMPORTANCE Sporadic Creutzfeldt-Jakob disease is caused by the misfolding of the cellular prion protein, which assumes two major different conformations (type 1 and type 2) and, together with the methionine/valine polymorphic codon 129 of the prion protein gene, contribute to the occurrence of distinct clinical-pathological phenotypes. Inoculation in laboratory rodents of brain tissues from the six possible combination of pathological prion protein type with codon 129 genotypes results in the identification of 3 to 4 strains of prions. We report on the identification of a novel strain of Creutzfeldt-Jakob disease isolated from a patient who carried an abnormally glycosylated pathological prion protein. This novel strain has unique biochemical characteristics, does not transmit to humanized transgenic mice, and shows exclusive transmission properties in bank voles. The identification of a novel human prion strain improves our understanding on the pathogenesis of the disease and on possible mechanisms of prion transmission

    212samples_1386markers_genepop

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    Text file (genepop input format) containing the genotypes used for population genomics analysis. The file contains the genotypes of 1386 SNPs typed in 212 individuals, from 10 population samples. The population order is TGN (TegnĂąe, Chioggia), TR (Tremiti islands), OT (Otranto), TP (Trapani), CSP (Capo Spartivento), TAV (Tavolara), GNS (Giannutri South), GNN (Giannutri North), PTF (Portofino) and GA (Gallinara)

    Data from: A population genomics insight by 2b-RAD reveals populations’ uniqueness along the Italian coastline in Leptopsammia pruvoti (Scleractinia, Dendrophylliidae).

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    Aim: Marine bioconstructions such as coralligenous formations are hot spot of biodiversity and play a relevant ecological role in the preservation of biodiversity by providing carbon regulation, protection and nursery areas for several marine species. For this reason, the European Union Habitat Directive included them among priority habitats to be preserved. Despite their ecological role is well-established, connectivity patterns are still poorly investigated, representing a limit in conservation planning. The present study pioneers a novel approach for the analysis of connectivity in marine bioconstructor species, which often lack suitable genetic markers, by taking advantage of next generation sequencing techniques. We assess the geographical patterns of genomic variation of the sunset cup coral Leptopsammia pruvoti Lacaze-Duthiers, 1897, an ahermatypic, non-zooxanthellate and solitary scleractinian coral species common in coralligenous habitats and distributed across the Mediterranean Sea. Location: The Italian coastline (Western and Central Mediterranean). Methods: We applied the restriction site associated 2b-RAD approach to genotype over 1,000 high quality and filtered Single Nucleotide Polymorphisms in 10 population samples. Results: The results revealed the existence of a strongly supported genetic structure, with highly significant pairwise FST values between all the population samples, including those collected about 5 kilometers apart from each other. Moreover, genomic data indicates that the strongest barriers to gene flow are between the western (Ligurian-Tyrrhenian Sea) and the eastern side (Adriatic Sea) of the Italian peninsula. Main conclusions: The strong differentiation found in L. pruvoti, is similar to that found in other species of marine bioconstructors investigated in this area, but it strongly contrasts with the small differences found in many fish and invertebrates at the same geographic scale. All in one, our results highlight the importance of assessing connectivity in species belonging to coralligenous habitats as, due to their limited dispersal ability, they might require specific spatial conservation measures
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