1,987 research outputs found
Current evidence on the use of the adalimumab biosimilar SB5 (ImraldiTM): a multidisciplinary perspective
Full text linkIntroduction: This review provides an overview of data from trials and real-world studies available for SB5 (ImraldiTM) across three main therapeutic areas: rheumatology, gastroenterology, and dermatology. Areas covered: A literature search for publications on data for SB5 efficacy/effectiveness, safety, and immunogenicity was undertaken. Expert opinion: Evidence derived from clinical studies suggest that the biosimilar SB5 is a safe and effective alternative to reference adalimumab. Considering that patients suffering from immune-mediated inflammatory diseases such as inflammatory arthritis, inflammatory bowel disease and psoriasis often require long-term biologic treatment, biosimilar medicines (such as SB5) can reduce healthcare costs while increasing access to effective treatments
Sequential versus standard triple first-line therapy for Helicobacter pylori eradication
No full textBackground: Non-bismuth quadruple sequential therapy (SEQ) comprising a first induction phase with a dual regimen of amoxicillin and a proton pump inhibitor (PPI) for five days followed by a triple regimen phase with a PPI, clarithromycin and metronidazole for another five days, has been suggested as a new first-line treatment option to replace the standard triple therapy (STT) comprising a proton pump inhibitor (PPI), clarithromycin and amoxicillin, in which eradication proportions have declined to disappointing levels. Objectives: To conduct a meta-analysis of randomised controlled trials (RCTs) comparing the efficacy of a SEQ regimen with STT for the eradication of H. pylori infection, and to compare the incidence of adverse effects associated with both STT and SEQ H. pylori eradication therapies. Search methods: We conducted bibliographical searches in electronic databases, and handsearched abstracts from Congresses up to April 2015. Selection criteria: We sought randomised controlled trials (RCTs) comparing 10-day SEQ and STT (of at least seven days) for the eradication of H. pylori. Participants were adults and children diagnosed as positive for H. pylori infection and naïve to H. pylori treatment. Data collection and analysis: We used a pre-piloted, tabular summary to collect demographic and medical information of included study participants as well as therapeutic data and information related to the diagnosis and confirmatory tests. We evaluated the difference in intention-to-treat eradication between SEQ and STT regimens across studies, and assessed sources of the heterogeneity of this risk difference (RD) using subgroup analyses. We evaluated the quality of the evidence following Cochrane standards, and summarised it using GRADE methodology. Main results: We included 44 RCTs with a total of 12,284 participants (6042 in SEQ and 6242 in STT). The overall analysis showed that SEQ was significantly more effective than STT (82% vs 75% in the intention-to-treat analysis; RD 0.09, 95% confidence interval (CI) 0.06 to 0.11; P < 0.001, moderate-quality evidence). Results were highly heterogeneous (I2 = 75%), and 20 studies did not demonstrate differences between therapies. Reporting by geographic region (RD 0.09, 95% CI 0.06 to 0.12; studies = 44; I2 = 75%, based on low-quality evidence) showed that differences between SEQ and STT were greater in Europe (RD 0.16, 95% CI 0.14 to 0.19) when compared to Asia, Africa or South America. European studies also showed a tendency towards better efficacy with SEQ; however, this tendency was reversed in 33% of the Asian studies. Africa reported the closest risk difference (RD 0.14 , 95% 0.07 to 0.22) to Europe among studied regions, but confidence intervals were wider and therefore the quality of the evidence showing SEQ to be superior to STT was reduced for this region. Based on high-quality evidence, subgroup analyses showed that SEQ and STT therapies were equivalent when STT lasted for 14 days. Although, overall, the mean eradication proportion with SEQ was over 80%, we noted a tendency towards a lower average effect with this regimen in the more recent studies (2008 and after); weighted linear regression showed that the efficacies of both regimens evolved differently over the years, having a higher reduction in the efficacy of SEQ (-1.72% yearly) than in STT (-0.9% yearly). In these more recent studies (2008 and after) we were also unable to detect the superiority of SEQ over STT when STT was given for 10 days. Based on very low-quality evidence, subgroup analyses on antibiotic resistance showed that the widest difference in efficacy between SEQ and STT was in the subgroup analysis based on clarithromycin-resistant participants, in which SEQ reached a 75% average efficacy versus 43% with STT. Reporting on adverse events (AEs) (RD 0.00, 95% CI -0.02 to 0.02; participants = 8103; studies = 27; I2 = 26%, based on high-quality evidence) showed no significant differences between SEQ and STT (20.4% vs 19.5%, respectively) and results were homogeneous. The quality of the studies was limited due to a lack of systematic reporting of the factors affecting risk of bias. Although randomisation was reported, its methodology (e.g. algorithms, number of blocks) was not specified in several studies. Additionally, the other 'Risk of bias' domains (such as allocation concealment of the sequence randomisation, or blinding during either performance or outcome assessment) were also unreported. However, subgroup analyses as well as sensitivity analyses or funnel plots indicated that treatment outcomes were not influenced by the quality of the included studies. On the other hand, we rated 'length of STT' and AEs for the main outcome as high-quality according to GRADE classification; but we downgraded 'publication date' quality to moderate, and 'geographic region' and 'antibiotic resistance' to low- and very low-quality, respectively. Authors' conclusions: Our meta-analysis indicates that prior to 2008 SEQ was more effective than STT, especially when STT was given for only seven days. Nevertheless, the apparent advantage of sequential treatment has decreased over time, and more recent studies do not show SEQ to have a higher efficacy versus STT when STT is given for 10 days. Based on the results of this meta-analysis, although SEQ offers an advantage when compared with STT, it cannot be presented as a valid alternative, given that neither SEQ nor STT regimens achieved optimal efficacy (≥ 90% eradication rate)
De-escalation of Biologic Treatment in Inflammatory Bowel Disease: A Comprehensive Review
Full text link20.500.12530/87853Introduction Biologic therapy is an effective treatment for inflammatory bowel disease [IBD]. However due to cost and safety concerns, dose de-escalation strategies after achieving remission have been suggested.Aim To critically review available data on dose de-escalation of biologics [or other advanced therapies] in IBD. We will focus on studies evaluating de-escalation to standard dosing in patients initially optimised, and also on studies assessing de-escalation from standard dosing.Methods A systematic bibliographic search was performed.Results The mean frequency of de-escalation after previous dose intensification [12 studies, 1,474 patients] was 34%. The corresponding frequency of de-escalation from standard dosing [five studies, 3,842 patients] was 4.2%. The relapse rate of IBD following anti-tumour necrosis factor [TNF] de-escalation to standard dosing in patients initially dose-escalated [10 studies, 301 patients] was 30%. The corresponding relapse rate following anti-TNF de-escalation from standard dosing [nine studies, 494 patients] was 38%. The risk of relapse was lower for patients in clinical, biologic, and endoscopic/radiological remission at the time of de-escalation. A role of anti-TNF therapeutic drug monitoring in the decision to dose de-escalate has been demonstrated. In patients relapsing after de-escalation, re-escalation is generally effective. De-escalation is not consistently associated with a better safety profile. The cost-effectiveness of the de-escalation strategy remains uncertain. Finally, there is not enough evidence to recommend dose de-escalation of biologics different from anti-TNFs or small molecules.Conclusions Any consideration for de-escalation of biologic therapy in IBD must be tailored, taking into account the risks and consequences of a flare and patients' preferences
IMPLEMENTATION OF A PHOTOVOLTAIC FLOATING COVER FOR IRRIGATION RESERVOIRS
Full text link[EN] The article presents the main features of a floating photovoltaic cover system (FPCS) for water irrigation reservoirs whose purpose is to reduce the evaporation of water while generating electrical power. The system consists of polyethylene floating modules which are able to adapt to varying reservoir water levels by means of tension bars and elastic fasteners. (C) 2013 Elsevier Ltd. All rights reserved.Redón-Santafé, M.; Ferrer-Gisbert, P.; Sánchez-Romero, F.; Torregrosa Soler, JB.; Ferran Gozalvez, JJ.; Ferrer Gisbert, CM. (2014). IMPLEMENTATION OF A PHOTOVOLTAIC FLOATING COVER FOR IRRIGATION RESERVOIRS. Journal of Cleaner Production. 66:568-570. doi:10.1016/j.jclepro.2013.11.006S5685706
El fortalecimiento de la Europa de los derechos mediante la adhesión de la Unión Europea al sistema del convenio
No full textTodos los derechos reservadosDesde que la Comisión Europea la sugiriera en un Memorandum en 1979 hasta su cristalización en el art. 6.2 TUE por el Tratado de Lisboa, la adhesión de la UE al CEDH se ha concebido siempre como la solución de las distorsiones en la tutela de derechos en el espacio europeo de derechos y la culminación de una relación armónica entre los sistemas nacionales, convencional y europeo de derechos. Pero cada uno de estos sistemas, a pesar de compartir valores comunes, desempeñan funciones diferentes y persiguen objetivos distintos. Por eso, la adhesión ha de realizarse teniendo en cuenta y respetando sus respectivas naturalezas e identidades, pero sin olvidar el valor constitucional que dicha adhesión comportará en caso de llegar a consumarse. Sin duda, la adhesión fortalecerá la garantía de los derechos fundamentales en los tres ordenamientos jurídicos, nacional, convencional y europeo, interconectándolos de manera más sólida, reforzará la legitimación del TJUE en la protección de los derechos fundamentales y consolidará el sistema convencional como el orden supremo del cumplimiento de los derechos fundamentales en el conteniente europeo. Por último, la adhesión contribuirá a consolidar la idea europea sobre un mismo entendimiento no solo de los derechos fundamentales, sino de la democracia y del Estado de Derecho. En definitiva, la adhesión ofrece una eficacia simbólica y política, un valor añadido en reforzar la unidad e integración europeas.Fundación Española para la Ciencia y la TecnologíaDepto. de Derecho ConstitucionalFac. de DerechoTRUEpu
Supplementary_Material – Supplemental material for EpidemIBD: rationale and design of a large-scale epidemiological study of inflammatory bowel disease in Spain
No full textSupplemental material, Supplementary_Material for EpidemIBD: rationale and design of a large-scale epidemiological study of inflammatory bowel disease in Spain by María Chaparro, Manuel Barreiro-de Acosta, José Manuel Benítez, José Luis Cabriada, María José Casanova, Daniel Ceballos, María Esteve, Hipólito Fernóndez, Daniel Ginard, Fernando Gomollón, Rufo Lorente, Pilar Nos, Sabino Riestra, Montserrat Rivero, Pilar Robledo, Cristina Rodríguez, Beatriz Sicilia, Emilio Torrella, Ana Garre, Esther García-Esquinas, Fernando Rodríguez-Artalejo and Javier P. Gisbert in Therapeutic Advances in Gastroenterology</p
The construction of opinion in Javier Marías: rhetorical-argumentative analysis of the columns published by the author between 2009 and 2013
Full text linkEl presente artículo tiene como objeto de estudio las columnas escritas por Javier Marías, entre los años 2009 y 2013, en el espacio semanal La Zona Fantasma, ubicado en la última página de El País Semanal, suplemento dominical del diario El País. Para el estudio se ha recurrido a un análisis de contenido, a partir de la retórica aristotélica y su posterior renovación por Charles Perelman y Lucie Olbrechts Tyteca, expuesta en su Tratado de la argumentación. La metodología seguida ha permitido identificar las particularidades y características en cuanto a temas, enfoque, estructura y lenguaje que el autor utiliza. Cuantitativamente, se identificaron los temas, los argumentos, el léxico y las figuras literarias de cada columna, y cualitativamente, las temáticas, la construcción del Ethos del autor y la interpretación de los resultados, a la luz del contexto que
enmarca los años en los que se escriben las columnasThis article has as object of study the columns written by Javier Marías between the years 2009 and 2013 in the weekly space “La Zona Fantasma”, located in the last page of El País Semanal, a Sunday supplement in the News Paper El País. For study purposes we have used an analysis of content based on the Aristotelian Rhetoric and its posterior renovation by Charles Perelman and Lucie Olbrechts-Tyteca, exposed in their Treaty of Argumentation. The methodology followed allowed to identify the particularities and characteristics in relation to topics, approach, structure and language the author uses. The qualitative contribution consisted of the conclusions about the data obtained.
This analysis focuses on the reflection around the topics, the construction of the author´s Ethos and the interpretation of the results due to the context that frames eventually, the years the column is writte
Theoretical and experimental analysis of a floating photovoltaic cover for water irrigation reservoirs
No full text[EN] The article presents the main design features and photovoltaic requirements of a FPCS (floating photovoltaic cover system) for water irrigation reservoirs whose purpose is to reduce the evaporation of water while generating electrical power. Also, a summary of installation costs and relationship with the yield performance is deeply analyzed. A prototype of 20 kWp was implemented, and given the success of the results observed, the whole surface reservoir was covered (4490 m(2) and 300 kWp). The paper analyses the first electricity productions of the system and from these data the CO2 balance of the facility is calculated. (C) 2014 Elsevier Ltd. All rights reserved.Redón-Santafé, M.; Torregrosa Soler, JB.; Sánchez-Romero, F.; Ferrer-Gisbert, P.; Ferran Gozalvez, JJ.; Ferrer Gisbert, CM. (2014). Theoretical and experimental analysis of a floating photovoltaic cover for water irrigation reservoirs. Energy. 67:246-255. doi:10.1016/j.energy.2014.01.083S2462556
Project and Design of a Special Agricultural Warehouse Developed in Phases in Valencia (Spain)
Full text link[EN] This article describes the developing phases to build warehouses for a Pomelo Company at Valencian County (East of Spain). The warehouses
are remarkable because they did not have many intermediate columns. Spatial and lightweight solutions are adopted and described. In the Projects
also natural ventilation and lighting have been considered with a successfully result. Erection conditions and Regulations have been taken also
account. It has been an inspiration motive for other consultants.Ferrer Gisbert, CM.; Ferrer-Gisbert, P.; Ferran Gozalvez, JJ.; Redón-Santafé, M.; Torregrosa Soler, JB.; Sánchez-Romero, F. (2020). Project and Design of a Special Agricultural Warehouse Developed in Phases in Valencia (Spain). Current Trends in Civil & Structural Engineering. 5(5):1-8. https://doi.org/10.33552/CTCSE.2020.05.000623S185
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