The present day world has been experiencing rapid technological advancement on the one hand and increasing number of diseases afflicting the human beings on the other. To deal with the later, medical devices are innovated and introduced in to the market (making use of the technological advancements), on a continuous basis across the world. However, taking an innovated medical device to the market poses innumerable challenges and therefore, these have to be clinically trialled before its launch to ensure safety and efficacy. Of late, India has emerged as one of the preferred destinations to carry out clinical studies due to numerous advantages, primarily its diverse human gene pool and cost-competitiveness. However, there is very little understanding on the landscape of medical devices clinically trialled in India. It is to throw light on this critical issue with respect to the selection of participants in the clinical trial process, selection of locations and determination of trial duration that the present study has been carried out. In addition, the role of patents associated with the introduction of new medical devices in relation to the key challenges is examined. Furthermore, we studied the characteristics of clinical trials by industry and non-industry sponsors and between cardiovascular and other disease related trials. The present study has been carried out based on secondary data covering 108 medical device clinical trial registrations accessed from Clinical Trial Registry of India (CTRI) database pertaining to the period 2008-2014. At the outset, the pattern of trials related to the most prominent diseases such as cardiology and cardiovascular diseases and those which are invasive and non-invasive are examined. Our findings indicate that almost 50% of the trials are related to diseases of cardiology, cardiovascular diseases and those which are invasive in nature. For studying the patenting aspect, we proposed a conceptual grouping of sponsors as Incumbent, Potential Entrant and Supporter, based on their patent holdings in the domestic market and in PCT (Patent Cooperation Treaty) filings. Patents owned by Primary Sponsor (PS) showed significant variations in their clinical trial characteristics particularly the invasiveness of device, disease type, locations and participants. Three quantitative models are developed to identify the factors that influence the selection of number of participants, locations and time taken to execute medical device clinical trials using multivariate statistical techniques. The results of the three conceptual models on number of participants, locations and trial duration showed invasiveness of device and disease type playing significant roles in all the three models. The number of PCTs owned by PS was found to be influential in selecting the number of locations and participants but not the patents owned in IPO (Indian Patent Office). We also observed significant differences between industry and non-industry sponsors in terms of their clinical trial characteristics. The findings of the study formed the basis to understand the medical device clinical trial landscape and other pertinent issues in the Indian context, which enabled us to derive appropriate inferences and policy implications.

Fundação de Amparo a Pesquisa do Estado da Bahia / A uniformity trail with potato was carried out at potato seed production area of FEPAGRO, Julio de Castilhos city, in 2003 agricultural year. Tuber yield of 3456 hills was evaluated with a set of basic units (BU) compound of 1; 2; 3; 4; 6; 8 and 12 hills per BU, in order to study the effect of size of BU about experimental plot dimensions, with width (W) and length (L) restricted to (W ≤ L). Soil heterogeneity index estimated to each BU and a heterogeneity contour map constructed to six hills per BU in the same row. Relationships between numbers of hills per BU and optimum plot size (X0) and correspondent area (S) were through three algebric methods: Meier & Lessman (1971), MO, and two methods related by Thomas (1974), MV and MC. Correlation analysis and path analysis allowed verify direct and indirect dependence among parameters that compound functions that represent each method analyzed and m2. The results showed that same number of hills per BU, MO demanded more area and presented results coherent with practices applications than MV and MC that presented values of S minor that equivalent to one hill, not feasible to application of treatments. As the magnitude of origin as magnitude of curve were determinative of X0. The area demand occurs more intensely as from four hills per BU. The MC method was least responsive to changes. The soil presented more homogeneity within rows, indication of plot orientation in area such as plot shape, narrow and length in the same row. / Foi instalado um ensaio de uniformidade com batata, na área de produção de tubérculos de batata-semente da FEPAGRO, em Júlio de Castilhos, RS, no ano agrícola de 2003. Foi avaliado o rendimento de tubérculos de batata de 3456 covas, que foram constituídos, inicialmente, de uma unidade básica (UB). Foram planejadas, ainda, parcelas compostas de 2; 3; 4; 6; 8 e 12 covas por UB, com o objetivo de estudar o efeito do tamanho da UB nas dimensões das parcelas experimentais. Aplicou-se uma restrição entre os comprimentos (C) e larguras (L) selecionadas (L ≤ C). Foram estimados índices de heterogeneidade do solo para cada tamanho de UB e representado um mapa de heterogeneidade para UB compostas de seis covas numa mesma fila. Obtiveram-se relações entre tamanho ótimo de parcela (X0), área correspondente (S) e os diversos números de covas por UB, por três métodos algébricos: o método descrito por Meier & Lessman (1971), MO, e dois métodos descritos por Thomas (1974), MV e MC. Além da análise de correlação verificou-se também a ocorrência de dependência direta e indireta entre os parâmetros que compõem as funções que representam cada método estudado e a área correspondente. Os resultados obtidos demonstraram que para um mesmo número de covas por UB, o método MO demandou mais área e apresentou resultados mais coerentes com aplicações práticas que MV e MC, que apresentaram valores de área inferiores a uma cova, incompatível à aplicação de tratamentos. Tanto a magnitude da origem quanto a da curva foram determinantes de X0. A demanda por área ocorreu mais intensamente a partir de quatro covas por UB, sendo o método MC o que menos respondeu às variações. O solo apresentou-se mais homogêneo dentro das filas, o que orientou a direção das parcelas na área, assim como a forma, devendo ter maior comprimento que largura.

The thesis is focused on tourism development in Klenčí pod Čerchovem and its surroundings in the south part of the Bohemian Forest. The main objective of this thesis has been to develop the project proposal, which could help solve the problems of tourism development. The situational analysis of tourism development in the area, setting marketing goals, selection of marketing strategies and creating a tourism development plan were important for the elaboration of the project proposal. The main goal of the thesis has been accomplished by the creation of the cycling nature trail ``What is hidden around the Starý Herštejn{\crqq} that is aimed at attracting attention to extinct villages, defunct glassworks, to the ruins of Starý Herštejn, to the monastery and attractions of Pivoň and other historical monuments hidden in the pure nature of the Bohemian Forest. Thanks to the cycling nature trail, visitors would learn more about historical development of human settlements and other attractions in the border area.

This Diploma Paper deals with relevant questions of natural science and geography excursions in Stožec and his surroundings. In this Paper there are 3 excursions outlined - Scientific and geographical excursion on nature trail Stožecká skála, Excursion to geological exposition in Stožec and Excursion to Information Center and to the Centre of environmental education in Stožec. These excursions are set for the pupils of the 4th and 5th year of primary schools. They are also complemented with working lists. Their aim is to deepen and to fix pupils´ knowledge.

Thesis evaluated the proportion of functionalist architecture and urbanism of the city Sezimovo Ústí. Based on the review of the literature, questionnaire surveys and their own particular field survey work, the author tried to understand the influence of functionalist architecture and Bata planning concepts and ideas to present of the city Sezimovo Ústí 2 and also tried to find links from this time in the life of city and incorporating them into the project of the trail and approximate these problems to today's generation.

The main purpose of this work was proposing of tourism trade product. This aim was achieved by research supply of events, which take place in Votice region and also finding out of demand on a basic of questionary research. The evalution of the experts from the areas related to product also contributed to the creation of an appropriate product. All those observations leaded to the creation of product called healthpath.

The main objective of my thesis was to project a design of a concrete chosen section of the cycling trail in the vicinity of the village of Kamenný Újezd, which is located in Southern Bohemia, south-west of České Budějovice. I propose two alternative cycling trails in accordance with the applicable standards, laws and technical conditions. A better alternative in terms of transport, economy, ecology and aesthetics, I elaborated to the phase of documentation for the notification of the construction of road according to Decree 104/1997 Sb.. In the project, I propose a direction solution, vertical solutions, width layout, road construction, earthworks, drainage, equipment and traffic signs. I analyzed property relations in the proposed cycling route and existing bicycle trails in the given locality. I suggested a cycling communication, which is multifunctional, therefore not only used by cyclists but also pedestrians, in-line skaters, and when appropriate, for occasional agricultural transport.

A avaliação e monitoramento de trilhas vêm sendo implantados nos últimos anos nas unidades de conservação brasileiras. No entanto, as escadas, como parte do caminho percorrido pelos usuários não são consideradas. Este tipo de infraestrutura ocorre com maior frequência em terrenos acidentados como onde se encontra o Parque Estadual Turístico do Alto Ribeira (PETAR), local selecionado para o desenvolvimento desta pesquisa. O presente trabalho teve como objetivos descrever e avaliar os fatores que colaboram na degradação dos degraus feitos com troncos de madeira; verificar se essas escadas podem ser avaliadas da mesma forma que o restante da trilha; e com base nos resultados obtidos propor um protocolo preliminar de avaliação e monitoramento deste tipo de estrutura nas trilhas em áreas naturais. Com base nas informações obtidas, procurou-se fornecer subsídio para o manejo de trilhas em áreas naturais, especialmente em unidades de conservação. A coleta de dados detalhados das escadas foi feita em julho de 2010. A análise das informações coletadas em campo mostra que: a) a extensão do segmento de escada influencia na quantidade de afundamentos nos pisos dos degraus; b) a declividade não interfere na intensidade de erosão e empoçamento; c) a ergonomia, apesar de não apresentar correlação com os impactos negativos ao meio, pode interferir na qualidade de experiência e segurança do usuário; d) a insolação interfere na quantidade de poças; e) a presença de cobertura de copas pode auxiliar na minimização de impactos de chuva; f) há a necessidade de melhor capacitação daqueles que trabalham no manejo de trilhas; e g) as escadas necessitam de avaliação e monitoramento diferenciadas do restante da trilha. Para o PETAR, foram selecionados para o protocolo preliminar de avaliação e monitoramento de escadas feitas com troncos de madeira os seguintes indicadores: 1) existência de raízes expostas; 2) rugosidade ou irregularidade do piso que dificulte o caminhamento; 3) presença de trilhas não oficiais e seu motivo; 4) largura do degrau; 5) profundidade do degrau; 6) altura do degrau; 7) distância do segmento de degraus; 8) pontos com maior afundamento no piso do degrau; 9) estruturas de drenagem bloqueadas por queda de vegetação e sedimentação; 10) presença de estrutura de drenagem no topo dos segmentos de escadas; e 11) erosão na base dos degraus. / The trail evaluation and monitoring have been undertaken in detail throughout Brazilian protected areas. However, stairs, as a component of the pathway used by the visitors, are not taken into account. This kind of infrastructure is present more frequently in steeper terrains as where Alto Ribeira Touristic State Park (PETAR) is located, the selected area for this research. The goals of this research were to describe and evaluate the elements that contribute to the wood stair degradation; verify if these stairs can be evaluated in the same way as the rest of the trail; and based on the results suggest a preliminary protocol to evaluate and monitor this kind of structure in natural area trails. Based on the results found, the objective is to contribute to the trail management in natural areas, especially in protected areas. The detailed data on the stairs was collected in July 2010. The analysis of the data demonstrates: a) the depression quantity on the tread was affected by the length of the stair section; b) the intensity of erosion and puddle were not affected by the tread grade; c) despite the fact that ergonomics didnt show correlation with the negative impacts, it can interfere in the quality of user experience and safety; d) the solar exposure influences the quantity of puddles; e) the presence of canopy cover can minimize raindrop impact; f) better training is needed for the staff involved in trail management; and g) the stairs need differentiated evaluation and monitoring from the rest of the trail. The following indicators were selected for the preliminary protocol to evaluate and monitor the PETAR wood stairs: 1) presence of exposed tree roots; 2) tread roughness that makes it difficult to walk; 3) presence of social trails and its causes; 4) step width; 5) step depth; 6) step height; 7) length of the stair section; 8) location of the deeper depression spots in the steps; 9) drainage structures obstructed by fallen vegetation or sedimentation; 10) presence of drainage structure at the top of the stair section; and 11) erosion in the bottom of the steps.

Contexto: Modificações químicas da superfície dos implantes dentários com o objetivo de aumentar a molhabilidade resultam em uma osseointegração mais rápida e melhor. Objetivo: O objetivo deste estudo foi avaliar o quociente de estabilidade do implante (ISQ) (implant stability quotient) de implantes com geometria idêntica, mas com tratamentos de superfície diferentes: jateamento de areia e ataque ácido (SAE) e a mesma superfície com uma modificação química para aumento da hidrofilia, dentro das primeiras 16 semanas de cicatrização. Materiais e Método: neste estudo clínico randomizado um total de 64 implantes (32 SAE - Grupo Controle e 32 SAE modificado - Grupo Teste) com o mesmo desenho geométrico, comprimento e diâmetro (cônico e compressivo, 4,3x10 mm) foram colocados na maxila posterior de 21 pacientes parcialmente desdentados. Os valores de ISQ foram coletados no pós - cirúrgico imediato (T0), com 1 semana (T1), 2 (T2), 3 (T3), 5 ( T4), 8 (T5), 12 (T6) e 16 semanas (T7). Os resultados foram comparados por meio do ANOVA de medidas repetidas. Resultados: O grupo teste apresentou valores de ISQ mais altos que o grupo controle (ANOVA - p<0,01) a partir da 5a semana. Quando comparados os grupos em relação ao tempo necessário para se atingir o ISQ >= 70 como uma referência, houve uma diferença estatisticamente significante (p<0,01) e um Hazard Ratio de 2,24 (IC 1,62-3,11). No acompanhamento de um ano um paciente com 2 implantes abandonou a pesquisa, e estes não puderam mais ser avaliados. A taxa de sobrevida de ambos grupos foi de 100% após um ano de acompanhamento. Conclusão: O presente estudo sugere que implantes com superfície hidrofílica osseointegram mais rápido que implantes com superfície SAE convencional. O ganho de estabilidade do grupo teste foi 2,24 vezes mais rápido que do grupo controle após 5 semanas de avaliação em leitos na maxila posterior. / Background: Chemical modifications of dental implant surface, to improve the wettability, results in a faster and better osseointegration. Purpose: The aim of this study was to evaluate the implant stability quotient (ISQ) of implants with the same design, treated with two different surfaces: Sandblasted Acid-Etched (SAE) and hydrophilic SAE, within the initial 16 weeks of healing. Materials and Method: For this RCT a total of 64 implants (32 SAE - Control Group and 32 modified SAE - Test Group) with the same design, length and diameter (conical and compressive, 4.3x10 mm) were inserted in the posterior maxillae of 21 patients partially edentulous. The ISQ values were collected at the post-surgery (T0), 1-week (T1), 2-weeks (T2), 3- weeks (T3), 5-weeks (T4), 8-weeks (T5), 12-weeks (T6) and 16-weeks (T7). The statistic test was ANOVA. Results: Test group presented ISQ values higher than the Control group (ANOVA - p<0.01) from 5th week. When comparing groups regarding the amount of time required to achieve ISQ >= 70 as a reference, there was a statistically significant difference (p <0.01), and a HR (Hazard Ratio) of 2.24 (CI 1.62- 3.11). At the one-year follow up, there was a drop out of one patient and two implants were no longer evaluated. Survival rate for both groups was of 100% after one year of follow up. Conclusion: The current study suggests that implants with hydrophilic surface (modified SAE) integrates faster than implants with SAE surface. Stability gain of the tested group was 2.24 times faster than the control group after five weeks of evaluation at the posterior region of maxillae.

Fatores ambientais abióticos, como o clima, possuem um efeito profundo sobre a biologia dos organismos e sua distribuição em diferentes habitats. Os insetos, sendo o grupo animal mais abundante do planeta, tem papel importante no entendimento de como as variações climáticas afetam a vida na Terra. Neste estudo, utilizamos as formigas-cortadeiras, da espécie Atta sexdens rubropilosa,, para tratar da importância da umidade na escolha de trilhas de forrageio. As colônias utilizadas foram separadas em dois grupos: um grupo controle, mantido em condições normais de alimentação, e um grupo experimental, alimentado com substrato seco, provocando desidratação da colônia. Os dois grupos foram submetidos a um teste de escolha de trilhas para coleta de água: uma das trilhas foi mantida úmida e a outra mantida seca. As formigas que passaram pelas trilhas, por 24 horas, foram contadas e medidas (estas últimas selecionadas aleatoriamente nas trilhas). Após análise de vídeos, os resultados mostraram que, para o fluxo, houve diferença significativa, tanto entre os grupos quanto entre as trilhas. O fluxo foi sempre maior no grupo experimental, em relação ao controle, e maior na trilha úmida que na trilha seca - sendo assimetricamente maior no grupo experimental. Este resultado demonstra que o estado fisiológico da colônia e das operárias influencia fortemente a saída de forrageadoras e a coleta de água. Além disso, mostra que a escolha da trilha foi influenciada pelo ambiente, com grande preferência das formigas pela trilha úmida. Com relação aos tamanhos, a diferença foi significativa para dois fatores: as formigas nas trilhas do grupo experimental eram, em média, menores do que as formigas do grupo controle. Há relatos de que formigas menores são especializadas em coletar água, o que explica este resultado: no grupo experimental, a dessecação impulsiona as formigas a coletar água de maneira sistemática para reidratação. No grupo experimental, as formigas eram menores na trilha seca do que as da trilha úmida, o que vai contra o esperado se levar em consideração as relações alométricas de perda evaporativa de água. É provável que esse fator esteja ligado ao engajamento na tarefa de coleta de água pelas formigas menores, que é constante nas duas trilhas, dada a necessidade da colônia. Mais estudos, no entanto, são necessários para aprimorar e aprofundar estas questões, especialmente levando em conta a dicotomia entre o comportamento individual e o coletivo / Environmental abiotic factors, such as weather, have a profound impact over the biology of organisms e their distribution on different habitats. Insects, being the most abundant animal group on the planet, play an important role to understand how climatic changes affect life on Earth. In this study, we use leafcutter ants of the species Atta sexdens rubropilosa in order to approach the importance of humidity in the choice of foraging trails. The colonies used were separated in two groups: a control group, kept under normal feeding conditions and an experimental group, fed with dry substrate, which provoked dehydration on the colony. Both groups were submitted to a test of trail choice for water collection: one of the trails was kept humid, while the other was kept dry. Ants that travelled through the trails over 24 hours were counted and measured (in the last case, randomly chosen on the trails). After video analysis, the results show that, regarding to flow, there was a significant difference between groups and between trails. Ants flow were always higher on the experimental group than on the control group, and higher on the humid trail than on the dry trail - being asymmetrically higher on the experimental group. These results show that the physiological state of the colony and the workers strongly influences the exit of foragers and the collection of water. Besides, it shows that trail choice was influenced by the environment, with ants preferring the humid trail. Regarding body size, the difference was significant for two factors: ants on the trails of the experimental group were, on average, smaller than ants from the control group. There are reports that smaller ants are specialized on water collection, which explains that difference: on the experimental group, dehydration pushes ants to collect water systematically for rehydrating. On the experimental group, ants were smaller on the dry trail than the ones on the humid trail, which goes against expected when we consider allometric relations for evaporative water loss. It is likely that this factor is connected to the smaller ant´s engagement to the water collection task, which is constant on both trails due the needs of the colony for water. More studies, however, are necessary to improve and deepen those questions, specially taking onto account the dichotomy between individual and collective behavior