Aplicación para el análisis, estudio y publicación del comportamiento en la utilización de Valenbisi

[ES] El trabajo realizado en este TFM ha consistido en realizar una aplicación que mediante el análisis de datos de los datos recopilados mediante la plataforma API APP CIUDAD obtenga unos resultados y los proporcione al público, su función consiste en recopilar un histórico de datos en tiempo real del estado de las estaciones de Valenbisi para poder prever su estado en el futuro, actualizar estas previsiones en función de los nuevos datos que van siendo obtenidos y proporcionar estos resultados a usuarios y propietarios de este servicio para la posible utilización o para la optimización de los recursos disponibles por la empresa.[EN] This Master Thesis consists of implementing an application that, upon analyzing the data collected through the API APP CITY platform, obtains some results and provides them to the public. The main function of the application is to compile a real-time data history of the status of Valenbisi stations in order to be able to forecast their status in the future, update these forecasts based on the new data that is being obtained. This results will be provided to the users, but also to service providers for its possible use in the optimization task of resources provision of new facilities.[CA] El treball realitzat en aquest TFM ha consistit en la realització d’una aplicació que mitjançant el anàlisis de dades, de les dades recopilades mitjançant la plataforma API APP CIUDAD obtinga uns resultats i els proporcione al públic, la seva funció consisteix en recollir un històric de dades en temps real del estat de les estacions de Valenbisi per a poder preveure el seu estat en el futur, actualitzar aquestes previsions en funció de les noves dades que van següent obtingudes y proporcionar aquests resultats a usuaris y propietaris d’aquest servei per a la possible utilització o per a la optimització dels recursos disponibles per l’empresa.Llinares Llinares, J. (2019). Aplicación para el análisis, estudio y publicación del comportamiento en la utilización de Valenbisi. http://hdl.handle.net/10251/129997TFG

Biomarker qualification at the European Medicines Agency: a review of biomarker qualification procedures from 2008 to 2020

Regulatory qualification of biomarkers facilitates their harmonised use across drug developers, enabling more personalised medicine. This study reviews various aspects of the European Medicines Agency's (EMA) biomarker qualification procedure, including frequency and outcome, common challenges, and biomarker characteristics. Our findings provide insights into EMA's biomarker qualification process and will thereby support future applications. All biomarker-related "Qualification of Novel Methodologies for Medicine Development" procedures that started from 2008 to 2020 were included. Procedural data were extracted from relevant documents and analysed descriptively. In total, 86 biomarker qualification procedures were identified, of which 13 resulted in qualified biomarkers. Whereas initially many biomarker qualification procedures were linked to a single company and specific drug development program, a shift was observed to qualification efforts by consortia. Most biomarkers were proposed (n=45) and qualified (n=9) for use in patient selection, stratification, and enrichment, followed by efficacy biomarkers (37 proposed, 4 qualified). Overall, many issues were raised during qualification procedures, mostly related to biomarker properties and assay validation (in 79% and 77% of all procedures, respectively). Issues related to the proposed context of use and rationale were least common, yet, were still raised in 54% of all procedures. While few qualified biomarkers are currently available, procedures focus increasingly on biomarkers for general use instead of those linked to specific drug compounds. The issues raised during qualification procedures illustrate the thorough discussions taking place between applicants and regulators - highlighting aspects that need careful consideration and underlining the importance of an appropriate validation strategy

Role of age and comorbidities in mortality of patients with infective endocarditis

[Purpose]: The aim of this study was to analyse the characteristics of patients with IE in three groups of age and to assess the ability of age and the Charlson Comorbidity Index (CCI) to predict mortality. [Methods]: Prospective cohort study of all patients with IE included in the GAMES Spanish database between 2008 and 2015.Patients were stratified into three age groups:<65 years,65 to 80 years,and ≥ 80 years.The area under the receiver-operating characteristic (AUROC) curve was calculated to quantify the diagnostic accuracy of the CCI to predict mortality risk. [Results]: A total of 3120 patients with IE (1327 < 65 years;1291 65-80 years;502 ≥ 80 years) were enrolled.Fever and heart failure were the most common presentations of IE, with no differences among age groups.Patients ≥80 years who underwent surgery were significantly lower compared with other age groups (14.3%,65 years; 20.5%,65-79 years; 31.3%,≥80 years). In-hospital mortality was lower in the <65-year group (20.3%,<65 years;30.1%,65-79 years;34.7%,≥80 years;p < 0.001) as well as 1-year mortality (3.2%, <65 years; 5.5%, 65-80 years;7.6%,≥80 years; p = 0.003).Independent predictors of mortality were age ≥ 80 years (hazard ratio [HR]:2.78;95% confidence interval [CI]:2.32–3.34), CCI ≥ 3 (HR:1.62; 95% CI:1.39–1.88),and non-performed surgery (HR:1.64;95% CI:11.16–1.58).When the three age groups were compared,the AUROC curve for CCI was significantly larger for patients aged <65 years(p < 0.001) for both in-hospital and 1-year mortality. [Conclusion]: There were no differences in the clinical presentation of IE between the groups. Age ≥ 80 years, high comorbidity (measured by CCI),and non-performance of surgery were independent predictors of mortality in patients with IE.CCI could help to identify those patients with IE and surgical indication who present a lower risk of in-hospital and 1-year mortality after surgery, especially in the <65-year group

Hyperoxemia and excess oxygen use in early acute respiratory distress syndrome : Insights from the LUNG SAFE study

Publisher Copyright: © 2020 The Author(s). Copyright: Copyright 2020 Elsevier B.V., All rights reserved.Background: Concerns exist regarding the prevalence and impact of unnecessary oxygen use in patients with acute respiratory distress syndrome (ARDS). We examined this issue in patients with ARDS enrolled in the Large observational study to UNderstand the Global impact of Severe Acute respiratory FailurE (LUNG SAFE) study. Methods: In this secondary analysis of the LUNG SAFE study, we wished to determine the prevalence and the outcomes associated with hyperoxemia on day 1, sustained hyperoxemia, and excessive oxygen use in patients with early ARDS. Patients who fulfilled criteria of ARDS on day 1 and day 2 of acute hypoxemic respiratory failure were categorized based on the presence of hyperoxemia (PaO2 > 100 mmHg) on day 1, sustained (i.e., present on day 1 and day 2) hyperoxemia, or excessive oxygen use (FIO2 ≥ 0.60 during hyperoxemia). Results: Of 2005 patients that met the inclusion criteria, 131 (6.5%) were hypoxemic (PaO2 < 55 mmHg), 607 (30%) had hyperoxemia on day 1, and 250 (12%) had sustained hyperoxemia. Excess FIO2 use occurred in 400 (66%) out of 607 patients with hyperoxemia. Excess FIO2 use decreased from day 1 to day 2 of ARDS, with most hyperoxemic patients on day 2 receiving relatively low FIO2. Multivariate analyses found no independent relationship between day 1 hyperoxemia, sustained hyperoxemia, or excess FIO2 use and adverse clinical outcomes. Mortality was 42% in patients with excess FIO2 use, compared to 39% in a propensity-matched sample of normoxemic (PaO2 55-100 mmHg) patients (P = 0.47). Conclusions: Hyperoxemia and excess oxygen use are both prevalent in early ARDS but are most often non-sustained. No relationship was found between hyperoxemia or excessive oxygen use and patient outcome in this cohort. Trial registration: LUNG-SAFE is registered with ClinicalTrials.gov, NCT02010073publishersversionPeer reviewe

Una aplicación de mensajería para dispositivos móviles cooperativos

[ES] El trabajo realizado en este TFG ha consistido en realizar una aplicación de mensajería para dispositivos móviles usando la tecnología bluetooth para la comunicación entre los dispositivos, su función consiste en establecer una conexión con otro dispositivo y poder enviar de una forma sencilla tanto mensajes de texto como archivos de todos los tipos mediante sockets bluetooth[EN] he work done in this TFG has consisted on realizing an aplication of messenger service to movile devices using bluetooth tecnology for the comunication between the devices, its function consists to connect two devices to send text messages and all type files in a simpler way using bluetooth sockets.Llinares Llinares, J. (2018). Una aplicación de mensajería para dispositivos móviles cooperativos. http://hdl.handle.net/10251/111167TFG

The orphan drug pipeline in Europe

status: publishe

Apolipoprotein E ε4 allele and malondialdehyde level are independent risk factors for Alzheimer’s disease

Background: The ε4 allele of Apolipoprotein E is involved in lipid metabolism. Oxidative stress produces an increase in lipid peroxidation that has been implicated in the pathogenic cascade in Alzheimer’s disease. This study estimated the effect of the ε4 allele, malondialdehyde and lipid levels on the risk for Alzheimer’s disease. Methods: A total of 41 control subjects and 73 patients with Alzheimer’s disease were recruited. The Apolipoprotein E genotype was determined by amplification of exon 4 of the Apolipoprotein E by polymerase chain reaction (PCR); malondialdehyde concentration was determined by high-pressure liquid chromatography, and serum lipids were measured by routine photometric techniques. Results: Malondialdehyde levels were significantly higher in Alzheimer’s disease patients independent of the Apolipoprotein E genotype and ε4 allele. The ε4 allele increases the risk of Alzheimer’s disease by 5.114 times and elevated malondialdehyde levels increase the risk by 9.342. Conclusion: The presence of ε4 allele and elevated malondialdehyde levels are independent risk factors for Alzheimer’s disease. These findings support the hypothesis that lipid peroxidation and ε4 allele contribute to the pathogenic cascade in Alzheimer’s disease by different pathways