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  • About
  • The Global ETD Search service is a free service for researchers to find electronic theses and dissertations. This service is provided by the Networked Digital Library of Theses and Dissertations.
    Our metadata is collected from universities around the world. If you manage a university/consortium/country archive and want to be added, details can be found on the NDLTD website.
71

Entrevista motivacional na prevenção da cárie precoce da infância na Atenção Primária à Saúde

Silva, Daniel Demétrio Faustino da January 2015 (has links)
Antecedentes: Cárie Precoce da Infância é uma doença de alta prevalência e severidade que acomente crianças nos primeiros anos de vida e por isso necessita de intervenções e abordagens precoces, sendo a primeira infância o período ideal para introduzir bons hábitos e iniciar programas educativo-preventivos de saúde bucal. Objetivos: a presente tese objetivou comparar a efetividade da Entrevista Motivacional (EM) em relação a Educação em Saúde Convencional (EC) em um programa direcionado a mães/pais/responsáveis de crianças para a prevenção da cárie precoce da infância, adicionalmente, verificar a frequência de declarações motivacionais de Dentistas e Técnicos em Saúde Bucal (TSB), antes e após um treinamento para EM, no contexto da Atenção Primária à Saúde (APS). Métodos: um ensaio comunitário randomizado foi realizado no Serviço de Saúde Comunitária do Grupo Hospitalar Conceição em Porto Alegre – RS, Brasil, onde 6 das 12 unidades de saúde foram sorteadas para que os Dentistas e TSB (n=41) recebessem um treinamento intensivo de 8 horas para aprendizagem ativa dos princípios básicos da EM e avaliados por instrumentos validados. Os exames de cárie foram realizados através do índice ICDAS por examinadores treinados e calibrados. Resultados: em análise preliminar foram avaliadas um total de 244 crianças com idade média de 14,4 meses e que receberam ao menos uma consulta odontológica durante o primeiro ano de vida. Análises de subgrupos foram realizadas para renda equivalente e escolaridade materna. Para ambas as análises, a Entrevista Motivacional teve melhor desempenho entre o grupo mais desfavorecido, mas não teve efeito significativo entre os mais ricos. Entre as crianças cujas famílias recebiam menos de R$ 450,00 mensais houve um RR=0,10 (IC95% 0,01-0,79), enquanto naquelas com ganhos superiores foi RR=0,59 (IC95% 0,10-3,36). Entre as crianças cujas mães tinham escolaridade menor que o fundamental houve um RR=0,09 (IC95% 0,01-0,96), enquanto entre aquelas com ensino fundamental ou mais, foi RR=0,38 (IC95% 0,08-1,89). Para ambas as variáveis, o termo de interação não foi significativa (renda p=0,15 e educação p=0,38). Nos resultados do treinamento dos profissionais para EM após 2 anos, observou-se manutenção da melhora das repostas no instrumento da consulta dialogada com diferença estatisticamente significativa para perguntas abertas, escutas reflexivas e percentual total de acertos (p<0,001), com tamanho de efeito grande (ES=1,12). Para o questionário de resposta útil, os profissionais continuaram usando mais perguntas abertas e escutas reflexivas (p<0,001), mantendo aumento no percentual de respostas compatíveis com EM (p<0,001). Igualmente, o tamanho de efeito manteve-se grande (ES=1,33) ao longo do tempo. Conclusões: embora os resultados sejam preliminares, os achados desse ensaio comunitário randomizado trazem evidências de que a abordagem de educação em saúde bucal baseada nos princípios da Entrevista Motivacional foi mais efetiva na redução de cárie precoce da infância no primeiro ano de vida de crianças de baixa renda e cujas mães tem pouca escolaridade quando comparadas a abordagem convencional. Adicionalmente, conclui-se que o treinamento dos profissionais da equipe de saúde bucal foi efetivo para para habilita-los a atuar dentro do espírito da Entrevista Motivacional, idependentemente da idade, experiência e formação profissional prévia, tornando a EM uma ferramenta viável para a prática na Atenção Primária à Saúde. / Background: Early childhood caries is a common and severe disease that affects children in their initial years of life. As such, it calls for early intervention and approaches, with early childhood the ideal period to introduce good habits and initiate education and preventative programs for oral health. Objectives: this thesis aimed to compare the effectiveness of Motivational Interviewing (MI) compared to Conventional Education in Health (EC) on a program directed to mothers/parents/guardians of children for the prevention of early childhood caries. Additionally, it studies the regularity of motivation talks by Dentists and Dental Hygienists (DH) before and after training in Motivational Interviewing, within the context of Primary Health Care (PHC). Methods: a randomized community study was held by the Community Health Service of the Conceição Hospital Group in Porto Alegre – RS, Brazil, where 6 of the 12 health units participated in a draw to allow Dentists and DHs (n=41) to undergo an 8-hour intensive training program to actively learn the basic principles of MI and assessed through valid instruments. Exams for caries were performed by trained and qualified examiners using the ICDAS index. Results: on preliminary analysis a total of 244 children were assessed, aging an average of 14,4 months and which had undergone at least one dental visit within the first year of life. Subgroup analyses were conducted for equivalent income and maternal level of education. For both analyses, Motivational Interviewing showed the best performance among the more underprivileged group, though it had no significant effect among the wealthier. Children from families earning less than BRL 450.00/month tended to show RR=0.10 (95%CI: 0.01-0.79), while among those with a higher income an RR=0.59 (95%CI: 0.10-3.36) was noted. Among children whose mothers had an education level below primary, an RR=0.09 (95%CI: 0.01-0.96) was found, while among those with primary education or higher, an RR=0.38 (95%CI: 0.08-1.89) was registered. For both variables, the interaction term was not very significant (income p=0.15 and education p=0.38). MI training results for professionals after 2 years showed stability in improved responses in consultations with dialogue, showing a statistically significant difference for open questions, reflective listening and the total percent of correct responses (p<0.001), with a effect size (ES=1.12). For the useful answer questionnaire, professionals continued using open questions and reflective listening (p<0.001), maintaining an increase in the percent of responses compatible with MI (p<0.001). The dimensions of the effect size were also considerable (ES=1.33) over the course of time. Conclusions: despite only preliminary results, the findings from this randomized community study show evidence that approaching oral health education based on the principles of Motivational Interviewing was more effective in the reduction of early childhood caries among children in the first year of life from lower income backgrounds and whose mothers have little education when compared to the conventional approach. Further, it was concluded that the training of professional from the oral health team was effective in qualifying them to act according to the concept of Motivational Interviewing, regardless of age, experience and previous professional formation, making MI a viable tool in the practice of Primary Health Care.
72

Entrevista motivacional na prevenção da cárie precoce da infância na Atenção Primária à Saúde

Silva, Daniel Demétrio Faustino da January 2015 (has links)
Antecedentes: Cárie Precoce da Infância é uma doença de alta prevalência e severidade que acomente crianças nos primeiros anos de vida e por isso necessita de intervenções e abordagens precoces, sendo a primeira infância o período ideal para introduzir bons hábitos e iniciar programas educativo-preventivos de saúde bucal. Objetivos: a presente tese objetivou comparar a efetividade da Entrevista Motivacional (EM) em relação a Educação em Saúde Convencional (EC) em um programa direcionado a mães/pais/responsáveis de crianças para a prevenção da cárie precoce da infância, adicionalmente, verificar a frequência de declarações motivacionais de Dentistas e Técnicos em Saúde Bucal (TSB), antes e após um treinamento para EM, no contexto da Atenção Primária à Saúde (APS). Métodos: um ensaio comunitário randomizado foi realizado no Serviço de Saúde Comunitária do Grupo Hospitalar Conceição em Porto Alegre – RS, Brasil, onde 6 das 12 unidades de saúde foram sorteadas para que os Dentistas e TSB (n=41) recebessem um treinamento intensivo de 8 horas para aprendizagem ativa dos princípios básicos da EM e avaliados por instrumentos validados. Os exames de cárie foram realizados através do índice ICDAS por examinadores treinados e calibrados. Resultados: em análise preliminar foram avaliadas um total de 244 crianças com idade média de 14,4 meses e que receberam ao menos uma consulta odontológica durante o primeiro ano de vida. Análises de subgrupos foram realizadas para renda equivalente e escolaridade materna. Para ambas as análises, a Entrevista Motivacional teve melhor desempenho entre o grupo mais desfavorecido, mas não teve efeito significativo entre os mais ricos. Entre as crianças cujas famílias recebiam menos de R$ 450,00 mensais houve um RR=0,10 (IC95% 0,01-0,79), enquanto naquelas com ganhos superiores foi RR=0,59 (IC95% 0,10-3,36). Entre as crianças cujas mães tinham escolaridade menor que o fundamental houve um RR=0,09 (IC95% 0,01-0,96), enquanto entre aquelas com ensino fundamental ou mais, foi RR=0,38 (IC95% 0,08-1,89). Para ambas as variáveis, o termo de interação não foi significativa (renda p=0,15 e educação p=0,38). Nos resultados do treinamento dos profissionais para EM após 2 anos, observou-se manutenção da melhora das repostas no instrumento da consulta dialogada com diferença estatisticamente significativa para perguntas abertas, escutas reflexivas e percentual total de acertos (p<0,001), com tamanho de efeito grande (ES=1,12). Para o questionário de resposta útil, os profissionais continuaram usando mais perguntas abertas e escutas reflexivas (p<0,001), mantendo aumento no percentual de respostas compatíveis com EM (p<0,001). Igualmente, o tamanho de efeito manteve-se grande (ES=1,33) ao longo do tempo. Conclusões: embora os resultados sejam preliminares, os achados desse ensaio comunitário randomizado trazem evidências de que a abordagem de educação em saúde bucal baseada nos princípios da Entrevista Motivacional foi mais efetiva na redução de cárie precoce da infância no primeiro ano de vida de crianças de baixa renda e cujas mães tem pouca escolaridade quando comparadas a abordagem convencional. Adicionalmente, conclui-se que o treinamento dos profissionais da equipe de saúde bucal foi efetivo para para habilita-los a atuar dentro do espírito da Entrevista Motivacional, idependentemente da idade, experiência e formação profissional prévia, tornando a EM uma ferramenta viável para a prática na Atenção Primária à Saúde. / Background: Early childhood caries is a common and severe disease that affects children in their initial years of life. As such, it calls for early intervention and approaches, with early childhood the ideal period to introduce good habits and initiate education and preventative programs for oral health. Objectives: this thesis aimed to compare the effectiveness of Motivational Interviewing (MI) compared to Conventional Education in Health (EC) on a program directed to mothers/parents/guardians of children for the prevention of early childhood caries. Additionally, it studies the regularity of motivation talks by Dentists and Dental Hygienists (DH) before and after training in Motivational Interviewing, within the context of Primary Health Care (PHC). Methods: a randomized community study was held by the Community Health Service of the Conceição Hospital Group in Porto Alegre – RS, Brazil, where 6 of the 12 health units participated in a draw to allow Dentists and DHs (n=41) to undergo an 8-hour intensive training program to actively learn the basic principles of MI and assessed through valid instruments. Exams for caries were performed by trained and qualified examiners using the ICDAS index. Results: on preliminary analysis a total of 244 children were assessed, aging an average of 14,4 months and which had undergone at least one dental visit within the first year of life. Subgroup analyses were conducted for equivalent income and maternal level of education. For both analyses, Motivational Interviewing showed the best performance among the more underprivileged group, though it had no significant effect among the wealthier. Children from families earning less than BRL 450.00/month tended to show RR=0.10 (95%CI: 0.01-0.79), while among those with a higher income an RR=0.59 (95%CI: 0.10-3.36) was noted. Among children whose mothers had an education level below primary, an RR=0.09 (95%CI: 0.01-0.96) was found, while among those with primary education or higher, an RR=0.38 (95%CI: 0.08-1.89) was registered. For both variables, the interaction term was not very significant (income p=0.15 and education p=0.38). MI training results for professionals after 2 years showed stability in improved responses in consultations with dialogue, showing a statistically significant difference for open questions, reflective listening and the total percent of correct responses (p<0.001), with a effect size (ES=1.12). For the useful answer questionnaire, professionals continued using open questions and reflective listening (p<0.001), maintaining an increase in the percent of responses compatible with MI (p<0.001). The dimensions of the effect size were also considerable (ES=1.33) over the course of time. Conclusions: despite only preliminary results, the findings from this randomized community study show evidence that approaching oral health education based on the principles of Motivational Interviewing was more effective in the reduction of early childhood caries among children in the first year of life from lower income backgrounds and whose mothers have little education when compared to the conventional approach. Further, it was concluded that the training of professional from the oral health team was effective in qualifying them to act according to the concept of Motivational Interviewing, regardless of age, experience and previous professional formation, making MI a viable tool in the practice of Primary Health Care.
73

Reprodutibilidade e comparação de diferentes métodos de avaliação de restaurações de resina composta em dentes posteriores

Podestá Rodriguez, Karina January 2007 (has links)
O objetivo deste estudo foi comparar diferentes métodos de avaliação de restaurações de resina composta em dentes posteriores, assim como avaliar a concordância intra-examinador. Cento e trinta e seis restaurações oclusais de resina composta foram avaliadas por um examinador treinado usando os critérios modificados do USPHS para avaliar quatro características das restaurações: integridade marginal, forma anatômica, descoloração marginal e textura superficial. Três métodos diferentes foram estudados: clínico, fotográfico e modelos. A reprodutibilidade intra-examinador foi medida através do teste de Kappa e a comparação de métodos através dos testes não-paramétricos de Fischer e Wilcoxon. Os resultados mostraram que os valores de concordância intra-examinador foram melhores na avaliação de integridade marginal e forma anatômica através de modelos, e os valores foram similares entre a avaliação clínica e fotográfica para integridade marginal e descoloração marginal. A textura superficial apresentou os valores mais baixos de concordância intra-examinador para todos os métodos examinados. O método direto foi significantemente diferente que os métodos indiretos para todas as características avaliadas (p< 0,05). Entretanto, quando os métodos foram avaliados segundo a aceitabilidade clínica considerada pelo USPHS, os métodos não foram diferentes. Os métodos fotográfico e modelos detectaram defeitos que não foram percebidos pelo método clínico na avaliação da integridade marginal e da forma anatômica. As avaliações através de fotografias e modelos foram semelhantes em todas as características avaliadas com exceção da textura superficial (p< 0,05). Todos os métodos mostraram ser inadequados para a avaliação de textura superficial. Houve diferenças significativas entre o método direto e os métodos indiretos. Os métodos indiretos permitiram realizar observações mais detalhadas e críticas. Entretanto, o método clínico mostrou ter capacidade para diferenciar entre restaurações clinicamente aceitáveis e não-aceitáveis. / The aim of this study was to compare different methods for evaluating composite resin restorations in posterior teeth and to evaluate the reproducibility of each method by determining the intraexaminer agreement. One hundred and thirty six occlusal composite resin restorations were evaluated by a trained examiner using modified USPHS criteria to assess four restoration characteristics: marginal integrity, anatomic form, marginal discoloration and surface texture. Three different methods were studied: clinical, photographic and dental cast models. Kappa statistics was used to determine reproducibility and non-parametric Friedman and Wilcoxon tests to compare the methods. The results showed that the best intraexaminer agreement values were obtained for dental cast models evaluations for marginal integrity and anatomic form and were similar between photographic and clinical evaluations for marginal integrity and marginal discoloration. Surface texture showed the lowest degree of intraexaminer agreement with all the methods tested. Direct clinical method and the two indirect methods were significantly different for all the characteristics assessed (p< 0.05). However, when they were evaluated according to USPHS clinical acceptability, the methods did not differ. Photographs and dental cast models methods detected defects that the direct clinical method could not distinguish for marginal integrity and anatomic form. Photographs and dental cast models evaluations were similar for all the characteristics assessed, except for surface texture (p< 0.05). All the methods showed that they are not adequate to evaluate surface texture. There were significant differences between the direct clinical method and the indirect methods for all the composite resin restorations characteristics assessed. The indirect methods allowed more detailed and critical observations. However, the direct clinical method was able to distinguish between clinical acceptable and unacceptable restorations.
74

Análise da influência das forças oclusais e fatores locais na morfologia das lesões cervicais não cariosas: estudo clínico transversal / Influence of occlusal forces and local factors in the morphology of noncarious cervical lesions: cross sectional trial

Fabrícia Araújo Pereira 01 February 2016 (has links)
Objetivo: Analisar por meio de um estudo clinico transversal a influência das forças oclusais, assim como, de outros possíveis fatores locais na morfologia de lesões cervicais não cariosas (LCNC). Material e Método: Foram avaliados 32 indivíduos que possuíam LCNC nos primeiros pré-molares superiores, totalizando uma análise de 61 dentes, além disso, todos os sujeitos da pesquisa apresentavam todos os elementos dentais. Os mesmos eram pacientes regulares do serviço odontológico da Universidade Federal de Uberlândia, de ambos os gêneros, com idades entre 21 a 64. Para confirmação da morfologia e da severidade (profundidade) das LCNC, foi realizado exame cínico e replica das mesmas. As LCNC foram classificadas em anguladas ou arredondadas e em 3 níveis de severidade. A fim de determinar a presença de forças laterais, a presença de algum tipo de hábito parafuncional, como apertamento e bruxismo, foi analisado por meio de questionário e exame clinico. Também foram analisados, a presença de interferências oclusais (IO) em Relação Cêntrica (RC) e Movimentos excursivos, por meio de exame clinico de manipulação e análise dos modelos de gesso montados em articulador, assim como informações sobre a presença de facetas de desgaste. Além disso, informações sobre o periodonto, também foram coletadas, por meio de exame clinico, da mensuração das recessões gengivais no sentido cérvico-apical e mésio-distal. Assim como, da altura e espessura da cortical óssea vestibular, realizada por meio de Tomografia Computadorizada do tipo Cone-Beam (TCCB). Resultados: Inicialmente, aplicou-se o teste de Shapiro wilk, para avaliar a normalidade dos dados. Para os dados normais, posteriormente, aplicou-se o teste de Kruskall-wallis. Enquanto, que para as variáveis que não apresentaram distribuição normal, foi aplicado o teste Mann- Whitney. Dados gerais da amostra, demonstraram que a idade apresentou associação tanto com a morfologia (p = ,016), quanto para a severidade das LCNC (p=,000). O que não foi encontrado para o gênero (morfologia, p =,139; severidade, p =,308), nem para a presença de algum distúrbio gástrico (morfologia, p =,260; severidade, p =,831). Além disso, nenhuma relação foi encontrada entre a preseça de hábitos parafuncionais ou alguma IO, com a morfologia e severidade das LCNC. Todos os sujeitos da pesquisa apresentaram facetas de desgaste, entretanto, a presença de uma ou duas facetas não influenciou a morfologia ou severidade das lesões. Já para a recessão gengival, associação significativa foi encontrada para a morfologia (p =,046). Em relação a altura e espessura da crista da cortical vestibular, a altura foi significante em relação a severidade (p= ,009), e a espessura da crista, apresentou associação com a morfologia (p=,001) e severidade (p=,044). Conclusão: Não houve associação direta entre a morfologia das LCNC e as forças oclusais, entretanto, a idade e o suporte ósseo (menor altura e cortical menos espessa), foram fatores determinantes para a prevalência de LCNC anguladas e mais severas. / Objective: Analyze through a cross clinical study the influence of occlusal forces, as well as other possible local factors in the morphology of cervical lesions noncarious (LCNC). Material and Methods: We evaluated 32 individuals who had LCNC the first premolars, totaling an analysis of 61 teeth, moreover, all the subjects had complete dental arches. They were regular patients of the dental service at the Federal University of Uberlândia, of both genders, ages 21 to 64. To confirm the morphology and severity (depth) of LCNC was held cynical examination and replicates them. The LCNC were classified into angled or rounded and three severity levels. In order to determine the presence of lateral forces, the presence of some kind of habit parafuncional as bruxism and clenching was analyzed by questionnaire and clinical examination. Were also analyzed, the presence of occlusal interferences (OI) in Relation Centrica (CR) and movements excursive through clinical examination manipulation and analysis of plaster models mounted on articulator, as well as information about the presence of wear facets. In addition, information about periodontal were also collected through clinical examination, measurement of gingival recession in cervical-apical and mesiodistally. As well as the height and thickness of the buccal bone cortical held by Computed Tomography Cone-Beam type (TCCB). Results: Initially, we applied the Shapiro Wilk test to assess the normality of the data. For normal data, later applied the Kruskal-wallis test. While that for variables without normal distribution, the Mann-Whitney test was applied. General data of the sample, showed that age was associated with both the morphology (p =. 016), as to the severity of LCNC (p =.000). What was not found for the genre (morphology, p = .139; severity, p = 308), or to the presence of some gastric disorder (morphology, p = .260; severity, p = 831). Furthermore, no relationship was found between the preseça of parafunctional habits or some IO, with the morphology and severity of LCNC. All the subjects showed wear facets, however, the presence of one or two aspects not influence the morphology or severity of the lesions. As for the gingival recession, significant association was found for morphology (p =.046). Regarding the height and thickness of the crest cortical bone, the height was significant in relation to severity (p =.009), and the thickness of the crest, was associated with the morphology (p = .001) and severity (p = .044). Conclusion: There was no direct association between the morphology of NCCL and occlusal forces, however, the age and the bony support (lower thinner height and cortical), were determining factors for the prevalence of NCCL angled and more severe.
75

Evaluation clinique et biomécanique d'un implant de stabilisation dynamique du rachis lombaire / Clinical and biomechanical evaluation of a dynamic stabilization device for the lumbar spine

Prud'homme, Marion 10 December 2014 (has links)
Les douleurs lombaires représentent l'une des premières causes d'intervention chirurgicale dans le monde, et requièrent le recours à une instrumentation du rachis complémentaire pour environ 1% des patients. La technique instrumentée standard est l'arthrodèse ; elle consiste en l'immobilisation des vertèbres adjacentes par un système composé de vis pédiculaires et de tiges. Les résultats cliniques sont généralement satisfaisants. Cependant, des cas de complications subsistent, en particulier la dégénérescence du segment adjacent pouvant entraîner une reprise chirurgicale. Pour répondre à ce problème, les implants dits « stabilisation dynamique » ont été conçus avec pour objectif de maintenir une mobilité au niveau instrumenté afin de ne pas sur-contraindre les structures environnantes. Cette étude consiste en l'évaluation clinique et biomécanique d'un de ces implants. Tout d'abord, nous avons mené une campagne d'essais de caractérisation mécanique de l'implant isolé afin de connaître précisément ses propriétés et de pouvoir le modéliser de façon fidèle et validée. Un travail clinique rétrospectif a ensuite été réalisé pour quantifier les résultats obtenus et proposer un protocole d'étude prospective qui réponde aux contraintes cliniques et aux exigences scientifiques actuelles. Une campagne d'essais in-vitro sur segment lombaire a ensuite été menée pour compléter notre connaissance du comportement biomécanique du rachis instrumenté. Ceci nous a permis de valider une modélisation en éléments finis du rachis instrumenté utilisé notamment pour étudier l'influence du design de l'implant ainsi que des gestes réalisés lors de la chirurgie. / Back pain is one of the first causes of surgical intervention in the world and instrumentation is needed for about 1 patient out of 100 . Fusion is the gold standard for instrumented surgery and consists in fixation of two adjacent vertebra together with pedicular screws and rigid rods. Clinical outcomes of fusion are satisfactory but some cases of adverse events remain such as adjacent segment degeneration sometimes leading to revision surgery. Dynamic stabilization devices have been proposed to tackle this issue with the objective of maintaining motion at the instrumented level and thus limiting the surrounding structure overloading. This work aims at assessing one dynamic stabilization device. We first performed mechanical testing on the device to better understand its functioning and come up with a detailed and validated model. Then a retrospective clinical work has been conducted to lay out the clinical performances of the device and propose a prospective study design to answer clinical and scientific requirements. A biomechanical in-vitro testing campaign has been set up to increase our knowledge about the behaviour of the instrumented spine. This enabled us to validate a finite elements model then used for the study of the influence of several design parameters but also of several choices made during the surgery.
76

Constructing a Clinical Research Data Management System

Quintero, Michael C. 04 November 2017 (has links)
Clinical study data is usually collected without knowing what kind of data is going to be collected in advance. In addition, all of the possible data points that can apply to a patient in any given clinical study is almost always a superset of the data points that are actually recorded for a given patient. As a result of this, clinical data resembles a set of sparse data with an evolving data schema. To help researchers at the Moffitt Cancer Center better manage clinical data, a tool was developed called GURU that uses the Entity Attribute Value model to handle sparse data and allow users to manage a database entity’s attributes without any changes to the database table definition. The Entity Attribute Value model’s read performance gets faster as the data gets sparser but it was observed to perform many times worse than a wide table if the attribute count is not sufficiently large. Ultimately, the design trades read performance for flexibility in the data schema.
77

Klinické hodnocení humánních léčivých přípravků v České republice / Clinical trials of medical products for human use in the Czech Republic

Baloušek, Filip January 2017 (has links)
The issue of legislative and ethical requirements on research of innovative medicines became more intense in connection to the expansion of the pharmaceutical industry in last few decades. This master thesis aims to complexly describe and analyse theoretical bases of current legislative regulating the process of clinical trials of medicinal products for human use in the Czech Republic, as well as to take a closer look to the issue of ethical review administered by specialized ethical review committees. The author also deals with some specific responsibilities of the committees from the perspective of administrative law, especially focusing on aspects of legal nature of the positive opinions, which are one of the conditions for commencement of a clinical trial. The thesis is divided into nine chapters and the introductory chapter is focused on the general outline of the issue of clinical trials of medicines for human use in the Czech Republic. The aim of the second chapter is to define the basic concepts stated in the Czech medicinal products act, which are specific for this area of pharmaceutical law. The next chapter analyses the relevant competencies of individual state authorities over the clinical studies. The fourth chapter contains the list of sources of law, whereas a particular emphasis is...
78

Is there an association between clinical and SEM quantitative marginal analysis in a 90-month trial?

Brückner, Amelie Verena Barbara 21 December 2021 (has links)
Purpose: To assess possible correlations between clinical outcomes and SEM marginal analysis in a prospective long-term clinical study using two adhesives in incisors and canines. Materials and Methods: Thirty-five patients received class III and IV restorations with two different adhesives, either the one-step self-etch adhesive iBond Gluma inside (1-SE) or the two-step etch-and-rinse adhesive Gluma Comfort Bond (2-ER) combined with the fine particle hybrid composite Venus. The restorations were clinically evaluated (modified USPHS criteria) over 90 months. Based on resin replicas, a quantitative marginal SEM analysis was performed using the criteria “gap”, “perfect margin”, “overhang”, and “underfilled”. The results of the quantitative marginal analysis were statistically compared and related to clinical evaluations. The SEM data were analyzed statistically using the Kolmogorov-Smirnov test, Wilcoxon test, and mixed models test. Results: Of the 35 subjects at baseline, 16 (1-SE) and 17 (2-ER) were clinically re-examined after 90 months. 13 patients were included in the SEM analysis due to uninterrupted documentation over 90 months or until restoration loss. SEM analysis showed larger discriminative power between groups than did the clinical examination, but the trend was the same. Marginal analysis (“gap”, “perfect margin”) showed significant differences between the materials after 12 months, which clinically began to show a trend from 12 months, and were statistically verified after 48 and 90 months. “Overhang” and “underfilled” did not reveal significant differences between the systems or over time. Conclusion: SEM marginal analysis using the replication technique is a powerful tool to reveal differences between adhesives. Compared to clinical evaluation, group differences can be detected earlier, with both outcome parameters confirming each other over long observation periods.:1. Referat 3 2. Einführung in die Thematik 4 Grundlagen des Adhäsivverbundes 4 Adhäsivsysteme 5 Untersuchung des Adhäsivverbundes 7 Anforderungen an Testverfahren 7 Testverfahren 8 Rasterelektronenmikroskopische Analyse des Restaurationsrandes 9 Vorhersage des klinischen Erfolgs 10 3. Zielsetzung und Hypothesen 12 4. Publikation 13 5. Zusammenfassung der Arbeit 24 6. Literaturverzeichnis 28 7. Wissenschaftliche Veröffentlichungen 33 Im Rahmen der Promotion 33 Im Rahmen der Weiterbildung zur Fachzahnärztin für Oralchirurgie 33 8. Erklärung über die eigenständige Abfassung der Arbeit 34 9. Lebenslauf 38 10. Danksagung 39
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Comparison of the Virological Response According to the Antiretroviral Regimens in Peruvian HIV Patients Who Presented the M184V Mutation in Two National Hospitals during the Years 2008 to 2019

Paredes, Raisa, Véliz, Fritner, Lucchetti, Aldo 01 March 2021 (has links)
El texto completo de este trabajo no está disponible en el Repositorio Académico UPC por restricciones de la casa editorial donde ha sido publicado. / Introduction: In patients with HIV in antiretroviral treatment (ART) and virological failure to the first-line regimen, establishing a therapeutic regimen after having identified the M184V mutation, which confers ART resistance, represents a dilemma. Objective: To compare the virological response of the therapeutic regimens prescribed to patients with HIV who presented the M184V mutation in two national hospitals in Lima, Peru, during the years 2008 to 2019, and to determine the risk factors associated with poor virological response. Methods: A retrospective cohort study was developed based on the information of the HIV program participants with the M184V mutation. Results: A total of 175 participants were eligible for the study. The male sex predominated (75.4%), the current median age was 41 years [interquartile range (IQR) 35.84-47.47], and the time on ART was 89 months (IQR 57.7-124.53). The median initial viral load (VL) was 4.5 log10 copies/mL (IQR 3.97-5.09) and the time between genotyping and the change of therapy was 2 months (IQR 0-3.56). The most used antiretroviral regimen was protease inhibitor plus two nucleoside reverse transcriptase inhibitors (55.4%). With the protease inhibitor plus integrase inhibitor (PI + INI) ART, 69% less risk of poor virological response was obtained [p = .019 (confidence interval 95% 0.117-0.825)]. Conclusions: In patients with HIV and the M184V mutation, the PI + INI ART has shown a greater decrease in control VL and, thus, a good virological response. The risk factors associated with a poor virological response were the delay between genotyping and change of therapy, high levels of initial VL, and poor adherence among the participants. / Revisión por pares
80

Migration to study in medical schools of Peru / Migración para estudiar en Escuelas de Medicina Human en Perú

Chambergo-Michilot, Diego, Muñoz-Medina, Carlos E., Lizarzaburu-Castagnino, Diego, León-Jiménez, Franco, Odar-Sampé, Miguel, Pereyra-Elías, Reneé, Mayta-Tristán, Percy 01 January 2020 (has links)
The aim of this study was to describe the frequency of migration to study medicine in Peru. We conducted a secondary data analysis of the Red-LIRHUS study (2011-2012). We included 3 680 Peruvian students. Approximately, 23.2% migrated for medical school. Less than 1% were international migrants. We found a higher proportion of migrant students in Universities outside of Lima than in Universities in Lima (27.1% vs. 15.8%). There was also a higher proportion of migrants in private universities (28.3% vs. 16.0%) Migrant students were more likely to live alone (27.4% vs. 6.4%) and to report having failed a module/course (51.0% vs. 38.6%) compared to non-migrant students. It is necessary to evaluate potential interventions for the preservation of the well-being of people who migrate for their medical training. / Revisión por pares

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