Clinical research monitoring: scenarios and challenges

Clinical research is essential for the development of new drugs, diagnostic tests and new devices. Clinical monitoring is implemented to improve the quality of research and attain high ethical and scientific standards. This review discusses the role of clinical monitors, taking into account the variety of scenarios in which medical research is developed, and highlights the challenges faced by research teams to ensure that patients rights are respected and that the social role of scientific research is preserved. Specific emphasis is given to the ethical dilemmas related to the multiple roles which clinical monitors play in the research framework, mainly those involving the delicate equilibrium between the loyalty to the sponsor and to the research subjects. The essential role of clinical monitoring for research developed in poor healthcare scenarios is highlighted as an approach to get the local infrastructure strengthening needed to achieve an adequate level of good clinical practices.

Extraction of Trypanosoma cruzi DNA from food: a contribution to the elucidation of acute Chagas disease outbreaks

Abstract: INTRODUCTION: Before 2004, the occurrence of acute Chagas disease (ACD) by oral transmission associated with food was scarcely known or investigated. Originally sporadic and circumstantial, ACD occurrences have now become frequent in the Amazon region, with recently related outbreaks spreading to several Brazilian states. These cases are associated with the consumption of açai juice by waste reservoir animals or insect vectors infected with Trypanosoma cruzi in endemic areas. Although guidelines for processing the fruit to minimize contamination through microorganisms and parasites exist, açai-based products must be assessed for quality, for which the demand for appropriate methodologies must be met. METHODS: Dilutions ranging from 5 to 1,000 T. cruzi CL Brener cells were mixed with 2mL of acai juice. Four Extraction of T. cruzi DNA methods were used on the fruit, and the cetyltrimethyl ammonium bromide (CTAB) method was selected according to JRC, 2005. RESULTS: DNA extraction by the CTAB method yielded satisfactory results with regard to purity and concentration for use in PCR. Overall, the methods employed proved that not only extraction efficiency but also high sensitivity in amplification was important. CONCLUSIONS: The method for T. cruzi detection in food is a powerful tool in the epidemiological investigation of outbreaks as it turns epidemiological evidence into supporting data that serve to confirm T. cruzi infection in the foods. It also facilitates food quality control and assessment of good manufacturing practices involving acai-based products.

Desenvolvimento do pensamento computacional com recurso ao Scratch: uma experiência com alunos do 8ºano

Relatório de estágio de mestrado em Ensino de Informática

Auditoria ambiental de l'edifici de l'Àrea de Territori, Medi Ambient, Paisatge i Espai Urbà de l'Ajuntament de Sitges

Aquest projecte realitza una auditoria ambiental de l’edifici de l’Àrea de Territori, Medi Ambient, Paisatge i Espai Urbà de l’Ajuntament de Sitges, com a primer pas per a la implantació d’un sistema de gestió ambiental (SGA), en acord amb el Reglament (CE) nº 761/2001, i la posterior obtenció d’un certificat de gestió i auditories ambientals (EMAS). L’auditoria s’inicia amb la identificació dels aspectes ambientals de l’edifici, mitjançant la recopilació de dades sobre consums energètics i hídrics, la estimació de la generació de residus i enquestes de mobilitat als treballadors. Aquestes dades són utilitzades per determinar els aspectes ambientals significatius i posteriorment, exposar una sèrie de propostes de millora per tal de corregir-los o minimitzar-los, com ara sistemes d’estalvi d’aigua, d’enllumenat, de producció d’electricitat i l’educació ambiental dels treballadors. Per a la implantació d’un SGA en la situació actual de l’edifici, es necessària, entre altres coses, la implantació d’un sistema de registre que arxivi els consums d’aigua, energia i generació de residus, per tal de dur un control de les despeses de cadascun dels vectors. A més, caldrà implementar un Programa de bones pràctiques ambientals en l’oficina per tal de reduir el consum elèctric, d’aigua i generació de residus, i la seva classificació per part dels treballadors.

Food security, food safety and small farmers

Some of the elements that characterize the globalization of food and agriculture are industrialization and intensification of agriculture and liberalization of agricultural markets, that favours elongation of the food chain and homogenization of food habits (nutrition transition), among other impacts. As a result, the probability of food contamination has increased with the distance and the number of “hands" that may contact the food (critical points); the nutritional quality of food has been reduced because of increased transport and longer periods of time from collection to consumption; and the number of food-related diseases due to changes in eating patterns has increased. In this context, there exist different agencies and regulations intended to ensure food safety at different levels, e.g. at the international level, Codex Alimentarius develops standards and regulations for the marketing of food in a global market. Although governments determine the legal framework, the food industry manages the safety of their products, and thus, develops its own standards for their marketing, such as the Good Agricultural Practices (GAP) programs. The participation of the private sector in the creation of regulatory standards strengthens the free trade of food products, favouring mostly large agribusiness companies. These standards are in most cases unattainable for small producers and food safety regulations are favouring removal of the peasantry and increase concentration and control in the food system by industrial actors. Particularly women, who traditionally have been in charge of the artisanal transformation process, can be more affected by these norms than men. In this project I am analysing the impcact of food safety norms over small farms, based on the case of artisanal production made by women in Spain.

Brushy Creek Lake: Improving Our Lake for the Future, 2006

While the quality of water in Brushy Creek Lake is currently adequate, a number of factors in the watershed (the surrounding area that drains into the lake) could put that water quality at risk. Sediment from the large watershed could fill in the lake and affect water clarity. Nutrients, like nitrogen and phosphorus, could cause algae blooms and other problems. Without preventative measures, potential manure and chemical spills could harm aquatic life in the lake. Using conservation farming practices and building structures like wetlands will work to maintain and even improve the lake’s water quality. Taking steps now to implement these critical practices will help prevent water quality problems, preserving water quality for future generations.

Climate Change Impacts on Iowa, 2010, January 1, 2011

Today, perhaps without their realization, Iowans are factoring climate change into their lives and activities. Current farming practices and flood mitigation efforts, for example, are reflecting warmer winters, longer growing seasons, warmer nights, higher dew-point temperatures, increased humidity, greater annual stream flows, and more frequent severe precipitation events (Fig. 1) than were prevalent during the past 50 years. Some of the effects of these changes (such as longer growing season) may be positive, while others (particularly the tendency for greater precipitation events that lead to flooding) are negative. Climate change embodies all of these results and many more in a complex manner. The Iowa legislature has been proactive in seeking advice about climate change and its impacts on our state. In 2007, Governor Culver and the Iowa General Assembly enacted Senate File 485 and House File 2571 to create the Iowa Climate Change Advisory Council (ICCAC). ICCAC members reported an emissions inventory and a forecast for Iowa’s greenhouse gases (GHGs), policy options for reducing Iowa’s GHG, and two scenarios charting GHG reductions of 50% and 90% by 2050 from a baseline of 2005. Following issuance of the final report in December 2008, the General Assembly enacted a new bill in 2009 (Sec. 27, Section 473.7, Code 2009 amended) that set in motion a review of climate change impacts and policies in Iowa. This report is the result of that 2009 bill. It continues the dialogue between Iowa’s stakeholders, scientific community, and the state legislature that was begun with these earlier reports.

Occurrence of patulin in organic and conventional apple juice. Risk assessment

Organic foods are promoted as environmentally friendly and its consumption has become increasingly popular. Nevertheless,organic farming practices could produce commodities more susceptible to fungal attack and as a result, food with higher levels of mycotoxins. Patulin is a mycotoxin mainly present in apples and apple-based products. In this paper, we report our recent results and an update of the patulin occurrence and their risk in conventional and organic apple juices around Europe.

Transferència de bones pràctiques educatives amb TIC a una escola bressol de nova creació

L’escola bressol és el primer centre educatiu on els infants tenen accés a l’era digital després de l’entorn familiar que és el primer que reben després del seu naixement. Aquests centres educatius també han de donar resposta a la societat digital que hi ha actualment per tal d’aconseguir un desenvolupament integral de l’infant. Per realitzar aquesta integració de les Tecnologies de la Informació i la Comunicació (TIC) al centre és important una bona formació per part dels docents i tenir clar quins són els elements que fan una bona pràctica TIC. En el present treball final de grau s’aprofundeix en les bones pràctiques educatives en l’ús de les TIC i, posteriorment, es realitza una proposta de transferència de les mateixes a una escola de nova creació.

Direct evidence for the existence of dairying farms in prehistoric Central Europe (4th millennium BC)

The molecular and isotopic chemistry of organic residues from archaeological potsherds was used to obtain further insight into the dietary trends and economies at the Constance lake-shore Neolithic settlements. The archaeological organic residues from the Early Late Neolithic (3922-3902 BC) site Hornstaad-Hornle IA/Germany are, at present, the oldest archaeological samples analysed at the Institute of Mineralogy and Geochemistry of the University of Lausanne. The approach includes 13C/12C and 15N/14N ratios of the bulk organic residues, fatty acids distribution and 13C/12C ratios of individual fatty acids. The results are compared with those obtained from the over 500 years younger Neolithic (3384-3370 BC) settlement of Arbon Bleiche 3/Switzerland and with samples of modern vegetable oils and fat of animals that have been fed exclusively on C3 forage grasses. The overall fatty acid composition (C9 to C24 range, maximizing at C14 and C16), the bulk 13C/12C and 15N/14N ratios (delta13C, delta15N) and the 13C/12C ratios of palmitic (C16:0), stearic (C18:0) and oleic acids (C18:1) of the organic residues indicate that most of the studied samples (25 from 47 samples and 5 from 41 in the delta13C18:0 vs. delta13C16:0 and delta13C18:0 vs. delta13C18:1 diagrams, respectively) from Hornstaad-Hornle IA and Arbon Bleiche 3 sherds contain fat residues of pre-industrial ruminant milk, and young suckling calf/lamb adipose. These data provide direct proof of milk and meat (mainly from young suckling calves) consumption and farming practices for a sustainable dairying in Neolithic villages in central Europe around 4000 BC.dagger

Performance of Various Thicknesses of Portland Cement Concrete, HR-9, 30 Year Report, 1981

If adequately designed and high quality material and good construction practices are used, portland cement concrete is very durable. This is demonstrated by the oldest pavement in Iowa (second oldest in the U.S.) paved in 1904, which performed well for 70 years without resurfacing. The design thickness is an important factor in both the performance and cost of pavement. The objective of this paper is to provide a 30-year performance evaluation of a pavement constructed to determine the required design thickness for low volume secondary roadways. In 1951 Greene County and the Iowa Highway Research Board of the Iowa Department of Transportation initiated a four-mile (6.4 km) demonstration project to evaluate thicknesses ranging from 4-1/2" (11.4 cm) to 6" (15.2 cm). The project, consisting of 10 research sections, was formed pavement placed on a gravel roadbed with very little preparation except for redistribution of the loose aggregate. Eight sections were non-reinforced except for centerline tie bars and no contraction joints were used. Mesh reinforcing and contraction joints spaced at 29' 7" (9.02 m) intervals were used in two 4-1/2" (11.4 cm) thick sections. The only air entrained section was non-reinforced. The pavement performed well over its 30-year life carrying a light volume of traffic and did not require major maintenance. There was substantial cracking with average slab length varying directly with thickness. The 4-1/2" (11.4 cm) thick non-air entrained, mesh-reinforced pavement with contraction joints has performed the best.

Observaciones y valoraciones realizadas por los estudiantes sobre la actividad: Inspeccionem els laboratoris farmacèutics?

En la asignatura de Farmacia Galénica III y Gestión de Calidad se ha llevado a cabo una actividad de campo en el curso 2011/2012, que consistía en una visita a 4 labo-ratorios farmacéuticos autorizados (Kern Pharma, Almirall, Reig Jofré y Novartis) para ver evidencias de cumplimientos de las NCF o GMP (Normas de Correcta Fa-bricación o Good Manufacturing Practices) en el entorno profesional y real.El objetivo del estudio es evaluar la capacidad analítica de los estudiantes de 4º cur-so de farmacia en cuanto a cumplimiento de las NCF. Para el desarrollo de la activi-dad se han organizado los estudiantes en diferentes grupos con la finalidad de “auditar”. La actividad implicaba preparar un cuestionario previo, realizar la visita y elaborar el informe final. Los resultados obtenidos han sido que aproximadamente un 97,1% de los alumnos han superado esta actividad con una nota media de 8,23. Se constata que la realización de esta actividad por parte de los estudiantes comporta una mejora de la calificación final de la asignatura respecto al curso previo.

Presència i distribució espacial de concentracions anormals d'ió nitrat a les aigües subterrànies dels aqüífers del Baix Fluvià (Alt Empordà)

Presentem una caracterització de la distribució espacial de la contaminació per nitrats en els aqüífers de la plana del baix Fluvià. En concret, els valors de concentració més elevats s’han observat a l’aqüífer superficial, on sobrepassen, amb escreix, els límits de potabilitat aconsellats pel RD 1138/1990. L’àrea més afectada ocupa part dels termes municipals de Vilamacolum i Torroella de Fluvià, en els quals hi predominen concentracions que oscil·len entre 50 i 200 mg × L–1. Els focus de contaminació són de tipus puntual i difús. Documentada la presència anormal de nitrats en aquest aqüífer, es planteja el correcte maneig agrícola, en vistes a una doble finalitat: d’una banda, contribuir a la planificació d’unes bones pràctiques agrícoles tenint en compte la relació entre volums de reg i aportacions de nitrogen; d’altra banda, preveure una progressiva recuperació de la qualitat de l’aqüífer, a partir de l’ús de tecnologies que integrin la ubicació d’unes zones favorables on es pugui maximitzar l’extracció del recurs contaminat, i la ubicació d’uns sòls aptes per a l’aplicació d’aquest recurs, amb uns criteris agronòmics coherents.

Buenas prácticas textuales e interpretabilidad de la letra pequeña

El examen de una normativa para mejorar la información al consumidor plantea observaciones pragmáticas sobre buenas prácticas textuales. La orden 385/2003 de la Generalitat de Catalunya establece el tamaño mínimo de la letra en contratos para facilitar su legibilidad. La interpretación de esta normativa permite considerar el uso pragmático de la letra pequeña. Y se recoge también el ejemplo publicitario de una empresa energética que paradójicamente utiliza, en la actualidad, como recurso de prestigio la letra pequeña en documentos contractuales. GOOD TEXTUAL PRACTICES AND INTERPRETABILITY OF THE FINE PRINT IN CONTRACTS. The review of legislation to improve consumer information raises pragmatic observations on textual practices. The order 385/2003 of the Autonomous Government of Catalonia (Spain) sets the minimum font size in contracts for readability. The interpretation of these rules allows us to consider the pragmatic use of the fine print. And the paper also includes advertising from an energy company that paradoxically used as a resource for prestige the fine print in contract documents.

Reuse of information for selection of methods and operating conditions for drying of pharmaceutical materials

Drying is a major step in the manufacturing process in pharmaceutical industries, and the selection of dryer and operating conditions are sometimes a bottleneck. In spite of difficulties, the bottlenecks are taken care of with utmost care due to good manufacturing practices (GMP) and industries' image in the global market. The purpose of this work is to research the use of existing knowledge for the selection of dryer and its operating conditions for drying of pharmaceutical materials with the help of methods like case-based reasoning and decision trees to reduce time and expenditure for research. The work consisted of two major parts as follows: Literature survey on the theories of spray dying, case-based reasoning and decision trees; working part includes data acquisition and testing of the models based on existing and upgraded data. Testing resulted in a combination of two models, case-based reasoning and decision trees, leading to more specific results when compared to conventional methods.