Clinical trials, informed consent, & emergency medicine: A systematic literature review

Background: In the United States, the Food and Drug Administration (FDA) regulates clinical trials. These regulations address good clinical practices as well as human subject protection (FDA, 2012). One of the most important legal and ethical concerns in clinical trials is informed consent. 21 CFR 50 governs human subjects research. Part 50.24 provides an emergency research exception to the informed consent requirement. Research was conducted to determine the appropriateness of this exception, whether the benefit justifies the exception, and its public health significance.^ Methods: A systematic literature review was conducted and articles were identified from peer-reviewed journals.^ Results: There is some variance in opinions regarding the appropriateness of the exception, but the literature reviewed found the study results of these trials justified the waiver.^ Conclusion: The exception to the informed consent requirement is likely appropriate and justified in emergency research when implemented within the specified guidelines.^

Estrategias para el diseño de un sistema de gestión ambiental en una bodega : (Mendoza, Argentina)

En los últimos tiempos se ha fomentado, a través de distintas normas, la protección del medio ambiente como parte integrante de las diferentes actividades y políticas tanto del sector público como privado, con el propósito de lograr un desarrollo equilibrado y sostenible, compatible con el actual modelo económico. En función de ello, en una bodega emplazada en Maipú (Mendoza, Argentina) se realizó un diagnóstico (Revisión Inicial Ambiental - RIA) para conocer la situación actual del establecimiento con respecto a su relación con el medio ambiente. Una vez recabada la información y concluido el diagnóstico, se planteó un plan de medidas de gestión ambiental. Dichas medidas, que incorporaron los nuevos conceptos de producción limpia, ecoeficiencia y buenas prácticas ambientales, fueron documentadas a través de registros y permitieron conocer el desempeño ambiental a partir de los indicadores propuestos para cada uno de los Puntos Críticos ambientales (PCA). La propuesta inicial del presente trabajo fue lograr que la implementación de las medidas de acción, junto con los registros e indicadores de desempeño ambiental, sirvieran de soporte decisorio y brindaran los lineamientos básicos para diseñar un Sistema de Gestión Ambiental (SGA) que, junto con las Auditorías Ambientales (AA), formaran parte de la propuesta final.

An Integrated Approach to Strategic Asset Management

This paper focuses on identifying and analysing the elements of Strategic Management for infrastructure and engineering assets. These elements are contended to involve an understanding of governance, corporate policy, corporate objectives, corporate strategy and interagency collaboration and will in turn, allow the ability determine a broader and more comprehensive framework for engineering asset management, ie a ‘staged approach’ to understanding how assets are managed within organisations. While the assets themselves have often been the sole concern for good management practices, other social and contextual elements have come into the mix in order to promote strategic asset management. The development of an integrated approach to asset management is at the base of the research question. What are the considerations and implications for adopting and implementing an integrated strategic asset management (ISAM) framework? While operational matters have been given prominence, a subset of corporate governance, Asset Governance, details the policies and processes needed to acquire, utilise, maintain and account for an organisation’s assets. Asset governance stems from the organisation’s overarching corporate governance principles; as a result it defines the management context in which engineering asset management is implemented. This aspect will be examined to determine the appropriate relationship between organisational strategic management and strategic asset management to further the theoretical engagement with the maturity of strategy,policy and governance for infrastructure and engineered assets. Asset governance stems from the organisation’s overarching corporate governance principles; as a result it defines the management context in which engineering asset management is implemented. The research proceeds by a document analysis of corporate reports and policy recommendations in terms of infrastructure and engineered assets. The paper concludes that incorporating an integrated asset management framework can promote a more robust conceptualisation of public assets and how they combine to provide a comprehensive system of service outcomes.

Urban agriculture in the new framework of green cities.

Urban Agriculture was a common practice in the old times. However after a period of low interest by urban population there is a movement of renaissance of urban agriculture especially in the new megalopolis. It is important to understand the role of UA in the new framework, and the interface of urban and rural agricultures, with their comparative advantages. Thus, we describe the impact of UA in several scenarios: political, socioeconomic and environmental. As a consequence several actions should be developed for improving the situation, with the stimulus to UA: urban planning, food value chain, appropriate technology, education and extension services, entertainment and leisure, selection of botanic varieties and agrochemical inputs, design and landscape and good farming practices. As a complement, there is an analysis of the Urban Greening Value Organization in our society. In the paper there is a description of the situation of urban agriculture in Spain (located mainly in roofs, walls, indoor and ground places) the existence of local regulations, barriers and opportunities in the new situation. Due to the social dimension of urban agriculture there are some comments about the role of the more significant stakeholders, and the goals and the structure of the neighbor communities.

Sistema de gestión de residuos de construcción y demolición en obras de edificación residencial. Buenas prácticas en la ejecución de obra

En el sector de la edificación, las grandes constructoras comienzan a considerar aspectos medioambientales, no limitándose a lo establecido por la legislación vigente, y buscando la implementación de buenas prácticas. Si bien este hecho es una realidad para las grandes empresas constructoras, todavía falta que la gran mayoría de las empresas del sector (pequeñas y medianas) adopten ésta tendencia. En este sentido, las publicaciones y estadísticas consultadas revelan que el sector de la construcción sigue siendo el sector con menor número de Sistemas de Gestión Ambiental (SGA) certificados en comparación con otros sectores industriales, debido principalmente a las peculiaridades de su actividad. Por otra parte, el sector de la construcción genera grandes cantidades de residuos de construcción y demolición (RCD). Aunque, en los últimos años la actividad de la construcción ha disminuido, debido a la crisis económica del país, no hay que olvidar todos los problemas causados por este tipo de residuos, o mejor dicho, por su gestión. La gestión de los RCD actual está lejos de alcanzar la meta propuesta en la Directiva Marco de Residuos (DMR), la cual exige un objetivo global para el año 2020 en el que el 70% de todos los RCD generados deberán ser reciclados en los países de la UE. Pero, la realidad es que sólo el 50% de la RCD generados en la Unión Europea se recicla. Por este motivo, en los últimos años se ha producido una completa modificación del régimen jurídico aplicable a los RCD, incorporando importantes novedades a nuestro ordenamiento interno como son: la redacción de un Estudio de gestión de RCD (en fase de diseño) y un Plan de gestión de RCD (en fase de ejecución). Entre estas medidas destaca el poder conocer, con la antelación suficiente, la cantidad y el momento en que los RCD son generados, para así poder planificar la gestión más adecuada para cada categoría de RCD. Es por ello que el desarrollo de cualquier instrumento que determine la estimación de RCD así como iniciativas para su control debe ser considerado como una herramienta para dar respuestas reales en el campo de la sostenibilidad en la edificación. Por todo lo anterior, el principal objetivo de la Tesis Doctoral es mejorar la gestión actual de los RCD, a través de la elaboración e implementación en obra de un Sistema de gestión de RCD en fase de ejecución que podrá ser incluido en el Sistema de Gestión Ambiental de las empresas constructoras. Para ello, se ha identificado la actividad que más residuo genera, así como las diferentes categorías de RCD generadas durante su ejecución, a través del análisis de nueve obras de edificación de nueva planta. Posteriormente, se han determinado y evaluado, en función de su eficacia y viabilidad, veinte buenas prácticas encaminadas a reducir la generación de RCD. También, se han identificado y evaluado, en función de su coste económico, cinco alternativas de gestión para cada categoría de RCD generada. Por último, se ha desarrollado e implementado un Sistema de Gestión de RCD en una empresa de construcción real. En definitiva, el Sistema de Gestión de RCD propuesto contiene una herramienta de estimación de RCD y también proporciona una relación de buenas prácticas, según su viabilidad y eficacia, sobre los aspectos más significativos en cuanto a la gestión de RCD se refiere. El uso de este Sistema de gestión de RCD ayudará a los técnicos de la construcción en el desarrollo de los documentos "Estudio de gestión de RCD " y "Plan de gestión de RCD " - requeridos por ley -. Además, el Sistema promueve la gestión ambiental de la empresa, favoreciendo la cohesión del proceso constructivo, estableciendo responsabilidades en el ámbito de RCD y proporcionando un mayor control sobre el proceso. En conclusión, la implementación de un sistema de gestión de RCD en obra ayuda a conseguir una actividad de edificación, cuyo principal objetivo sea la generación de residuos cero. ABSTRACT Currently, in the building sector, the main construction companies are considering environmental issues, not being limited to the current legislation, and seeking the implementation of good practices. While this fact is a reality for large construction companies, still the vast majority of construction companies (small and medium enterprises) need to accept this trend. In this sense, official publications and statistics reveal that the construction sector remains with the lowest number of certified Environmental Management Systems (EMS) compared to other industrial sectors, mainly due to the peculiarities of its activity. Moreover, the construction industry in Spain generates large volumes of construction and demolition waste (CDW) achieving a low recycling rate compared to other European Union countries and to the target set for 2020. Despite the complete change in the legal regime for CDW in Spain, there are still several difficulties for their application at the construction works. Among these difficulties the following can be highlighted: onsite segregation, estimating CDW generation and managing different CDW categories. Despite these difficulties, the proper CDW management must be one of the main aspects considered by construction companies in the EMS. However, at present the EMS used in construction companies consider very superficially CDW management issues. Therefore, current EMS should go a step further and include not only procedures for managing CDW globally, but also specific procedures for each CDW category, taking into account best practices for prevention, minimization and proper CDW management in order to achieve building construction works with zero waste generation. The few scientific studies analysing EMS implementation in construction enterprises focus on studying the benefits and barriers of their implementation. Despite the drawbacks found, implementing an EMS would bring benefits such as improving the corporate image in relation to the environment, ensuring compliance with the law or reducing environmental risks. Also, the international scientific community has shown great interest in defining models to estimate in advance the CDW that will be generated during the building construction or rehabilitation works. These studies analyse the overall waste generation and its different CDW categories. However, despite the many studies found on CDW quantification, analysing its evolution throughout the construction activities is a factor that must be further studied and discussed in greater depth, as results would be of great significance when planning the CDW management. According to the scientific studies analysing the implementation of good environmental practices in construction sites, it seems that, in general, the CDW collection system is done in a decentralized manner by each subcontracted company. In addition, the corporate image generated when poor practices are done may adversely affect the company's reputation and can result in loss of contracts. Finally, although there are numerous guides and manuals of good practices for CDW management, no references have been found implementing these measures in the Environmental Management System of the construction companies. From all the above, this thesis aims to provide answers to reduce the environmental impact caused by CDW generation in building construction works, in order to get a building process with zero waste generation. In this sense, is essential to generate new knowledge in order to implement a system which can carry out comprehensive management of CDW generated onsite, at the design stage until the end of its life cycle, taking into account both technical and economic criteria. Therefore, the main objective of this thesis is to define and implement a CDW management system for residential building construction works, helping construction agents not only to manage the CDW in accordance with current legislation, but also minimizing their generation on site by applying best practices, resulting in achieving the goal of zero waste in building works.

Singularities and undefinitions in the calibration functions of sonic anemometers

A mathematical model of the process employed by a sonic anemometer to build up the measured wind vector in a steady flow is presented to illustrate the way the geometry of these sensors as well as the characteristics of aerodynamic disturbance on the acoustic path can lead to singularities in the transformation function that relates the measured (disturbed) wind vector with the real (corrected) wind vector, impeding the application of correction/calibration functions for some wind conditions. An implicit function theorem allows for the identification of those combinations of real wind conditions and design parameters that lead to undefined correction/ calibration functions. In general, orthogonal path sensors do not show problematic combination of parameters. However, some geometric sonic sensor designs, available in the market, with paths forming smaller angles could lead to undefined correction functions for some levels of aerodynamic disturbances and for certain wind directions. The parameters studied have a strong influence on the existence and number of singularities in the correction/ calibration function as well as on the number of singularities for some combination of parameters. Some conclusions concerning good design practices are included.

Human-modified ecosystems and future evolution

Our global impact is finally receiving the scientific attention it deserves. The outcome will largely determine the future course of evolution. Human-modified ecosystems are shaped by our activities and their side effects. They share a common set of traits including simplified food webs, landscape homogenization, and high nutrient and energy inputs. Ecosystem simplification is the ecological hallmark of humanity and the reason for our evolutionary success. However, the side effects of our profligacy and poor resource practices are now so pervasive as to threaten our future no less than that of biological diversity itself. This article looks at human impact on ecosystems and the consequences for evolution. It concludes that future evolution will be shaped by our awareness of the global threats, our willingness to take action, and our ability to do so. Our ability is presently hampered by several factors, including the poor state of ecosystem and planetary knowledge, ignorance of human impact, lack of guidelines for sustainability, and a paucity of good policies, practices, and incentives for adopting those guidelines in daily life. Conservation philosophy, science, and practice must be framed against the reality of human-dominated ecosystems, rather than the separation of humanity and nature underlying the modern conservation movement. The steps scientists can take to imbed science in conservation and conservation in the societal process affecting the future of ecosystems and human well-being are discussed.

Acompanhamento da construção de uma captação de água subterrânea

Tese de mestrado, Geologia Aplicada (Hidrogeologia) Universidade de Lisboa, Faculdade de Ciências, 2016

Bénéfices de la diversité culturelle en entreprises : Études de cas dans les entreprises québécoises

Mémoire numérisé par la Direction des bibliothèques de l'Université de Montréal

Developments in the Agricultural and Rural Capital Market of the Former Yugoslav Republic of Macedonia. Factor Markets Working Paper No. 9, October 2011

The undeveloped rural capital market in the Former Yugoslav Republic of Macedonia is constrained by an urban–rural development gap, with limited capacities for rural development and imperfections in the rural capital market. Among the most striking hindrances are the illegal status of a large share of agricultural buildings and other real estate in rural areas, particularly on the individual family farms that prevail in the country, and the insufficient knowledge and abilities of individual farmers in applying for credit. National, EU and other donor funds are being used to improve knowledge, skills and other human resources, and to address the illegal status of buildings and facilities. In recent years, government support for agricultural, rural and regional development has been introduced to promote good agricultural practices, production and economic activity in rural areas. The elimination of imperfections and improvements to the functioning of the capital market – making access to credit and funds easier, especially for small-scale family farms and for rural development – are seen as measures contributing to agriculture and more balanced rural and regional development.

A intervenção do exercício físico funcional em idosos hipertensos do sexo feminino

Introdução - A abordagem da intervenção promotora da atividade física funcional em um grupo de idosas hipertensas consiste em considerar a pessoa na sua integridade física, psíquica e social. Objetivo – Avaliar o efeito da implementação de um programa de treinamento funcional sobre a pressão arterial em repouso em mulheres idosas hipertensas, submetidas ao treinamento de exercício físico durante um período de 24 meses. Métodos - Pesquisa de caráter exploratório, com orientação analítico-descritiva com a finalidade de analisar a ação da atividade física direcionada e implementada três vezes por semana no prognóstico da hipertensão arterial. Esta pesquisa foi suportada na recolha de dados da pressão arterial em repouso numa amostra de idosas brasileiras na faixa etária de 60 a 90 anos, em condições de excelente motivação por parte do grupo. Para as análises estatísticas foi utilizado o programa IBM SPSS 20, onde os dados foram tratados de forma descritiva e inferencial. Verificou-se o pressuposto de parametria quanto à normalidade dos resíduos para PAS e PAD ao longo das avaliações pressóricas na amostra pelo teste K-S, onde o mesmo não foi detectado (p<0,05). Assim, foram utilizados o teste de X2 e de Comparações Múltiplas para observações acerca de quais diferenças estatísticas eram significativas (p<0,05), além da Análise de Correlação de Pearson (rho) para apontar as devidas associações entre os níveis de PAS e PAD durante o estudo. Resultados – A maioria (100%) das idosas estavam hipertensas, constatando-se que durante o período de treino apresentaram pressão arterial sistólica e diastólica muito abaixo do padrão da normalidade para essa faixa etária. Tal decréscimo foi altamente significativo (p<00,1) e foi detectado tanto nas estatísticas comparativas quanto nas de associação. Conclusões - Após a intervenção do Projeto Prevenção de Saúde Estádio Vivo, as idosas apresentaram redução e maior controle dos valores da sua pressão arterial. Considera-se assim, que o treinamento físico ao exercer um efeito fisiológico especifica ao nível muscular e cardiocirculatório é protetor do estado de saúde global pelo que deve ser incentivado ao longo de todo o ciclo vital. Infere-se também que o Programa implementado pode ser replicado como medida de educação terapêutica, de avaliação e de auditoria de boas práticas em saúde. Palavra-chave: Idosos. Atividade Física. Hipertensão.

Bénéfices de la diversité culturelle en entreprises : Études de cas dans les entreprises québécoises

Mémoire numérisé par la Direction des bibliothèques de l'Université de Montréal

Grain yield of direct seeded and transplanted rice in rainfed lowlands of South East Asia

The mean grain yield of 81 direct seeded (DS) and 91 transplanted (TP) environments that were conducted as part of 3 ACIAR projects over 11 years, from 1992-2002, in Laos, Thailand and Cambodia were examined. The average yield of TP rice was 6% greater than DS rice. A subset of 27 pairs of DS and TP environments was examined and results indicated a significant positive correlation between the DS and TP establishment methods for mean grain yield with only a 3% difference in overall performance. The performance of 3 genotypes in 3 locations in Laos in 1996 was also examined. Results indicated a highly significant positive correlation between the performance of genotypes in DS and TP experiments in which TP rice had a 30% yield advantage over DS rice. This particular experiment highlights the need for good management practices when DS establishment methods are utilised. Results of this paper indicate that DS and TP rice will produce a similar yield for a given environment provided that they are grown utilising good management practices.

Pattern-based reuse of successful designs: usability ofsafety-critical systems

Users of safety-critical systems are expected to effectively control or monitor complex systems, with errors potentially leading to catastrophe. For such systems, safety is of paramount importance and must be designed into the human-machine interface. While many case studies show how inadequate design practice led to poor safety and usability, concrete guidance on good design practices is scarce. The paper argues that the pattern language paradigm, widely used in the software design community, is a suitable means of documenting appropriate design strategies. We discuss how typical usability-related properties (e.g., flexibility) need some adjustment to be used for assessing safety-critical systems, and document a pattern language, based on corresponding "safety-usability" principles

Quality Assurance in Extreme Programming

Our previous research about possible quality improvements in Extreme Programming (XP) led us to a conclusion that XP supports many good engineering practices but there is still place for refinements. Our proposal was to add dedicated Quality Assurance (QA) measures, which should be sufficiently effective and at the same time simpler enough in the context of XP. This paper intends to analyze the possibilities for an effective way for applying approved quality assurance practices to XP. The last should not affect negatively to the process and in the meantime must lead to better quality assurance. We aim to make changes to XP that even if would slow down a bit the development process, will make it more suitable for widest range of projects including large and very large projects as well as life critical and highly reliable systems.