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1
Plews, Caroline Margaret Coatsworth. « Clients' reports of the work of health visitors in the child health clinic and during home visits ». Thesis, University of Hull, 2001. http://hydra.hull.ac.uk/resources/hull:4626.
Texte intégralRésumé :
This study examines clients' reports of aspects of a single child health clinic visit and of a home visit by the health visitor. There are two foci of the thesis. First: recall; value and use of the advice/information selected by the client as the most important; second, an exploration of the meaning of support identified by some clients.Seven health visitors participated in the research, which incorporated two studies. In the first study, the researcher observed the content of discussions between 100 clients and the health visitor in child health clinics. These clients were then interviewed at home and asked questions about the advice/information received from the health visitor during theirprevious visit to the child health clinic.For the second study, information was recorded by the health visitor describing the content of 149 home visits. Clients were interviewed at home and asked similar questions regarding advice/information received from the health visitor. In addition, those clients who described receiving support were asked to describe the meaning to them of this aspectof the visit.Data analysis for both studies included descriptive and inferential statistics and content analysis.Findings from both studies indicate that recall of advice/information is related to the amount of advice/information given to the client. This may have implications for the amount of advice/information that health visitors are encouraged to provide.Advice/information received from the health visitor was generally valued and used by the mothers in both studies. Clients appeared most likely to be dissatisfied when topics had been raised which they had no interest in discussing. It is suggested that that there may be correspondence between some clients' descriptions of support, and taxonomies of social support found in social support literature. An exploration of health visiting work employing the concepts of social support is recommended.
2
Randmaa, Maria. « Communication and Patient Safety : Transfer of information between healthcare personnel in anaesthetic clinics ». Doctoral thesis, Uppsala universitet, Institutionen för folkhälso- och vårdvetenskap, 2016. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-278726.
Texte intégralRésumé :
Communication errors are frequent during the perioperative period and cause clinical incidents and adverse events. The overall aim of the thesis was to study communication – the transfer of information, especially the postoperative handover – between healthcare personnel in an anaesthetic clinic and the effects of using the communication tool SBAR (Situation-Background-Assessment-Recommendation) from a patient safety perspective. The thesis is based on studies using a correlational (Paper I), quasi-experimental (Paper II and III) and descriptive (Paper IV) design. Data were collected using digitally recorded and structured observations of handovers, anaesthetic records, questionnaires, incident reports and focus group interviews. The results from baseline data showed that lack of structure and long duration of the verbal postoperative handover decreased how much the receiver of postoperative handover remembered; the item most likely not to be remembered by the receiver was anaesthetic drugs. The variation in remembered information showed that there were room for improvement (Paper I). Implementing the communication tool SBAR increased memorized information among receivers following postoperative handover. Interruptions were frequent during postoperative handover, which negatively affected memorized information (Paper III). Furthermore, after implementation of SBAR, the personnel’s perception of communication between professionals and the safety climate improved, and the proportion of incident reports related to communication errors decreased in the intervention group (Paper II). The results of the focus group interviews revealed that the nurse anaesthetists, anaesthesiologists and post-anaesthesia care unit nurses had somewhat different focuses and views of the postoperative handover, but all professional groups were uncertain about having all information needed to secure the quality of postoperative care (Paper IV). The findings indicate that using a predictable structure during postoperative handover may improve the information memorized by the receiver, perception of communication between professionals and perception of safety climate. Incidents related to communication errors may also decrease. Long duration of the handover and interruptions may negatively affect the information memorized by receiver. To ensure high quality and safe care, there is a need to achieve a shared understanding across professionals of their work in its entirety.
3
Molloy, Mari. « Research projects reports and professional and ethical issues report ». Thesis, The Author [Mt. Helen, Vic.] :, 2004. http://researchonline.federation.edu.au/vital/access/HandleResolver/1959.17/40390.
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4
Meagher, Brendan University of Ballarat. « Clinical placement reports and professional and ethical issues reports ». University of Ballarat, 2006. http://archimedes.ballarat.edu.au:8080/vital/access/HandleResolver/1959.17/12760.
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"The first report describes a case of Major Depressive Disorder (MDD) in a pregnant women living in regional Australia. It begins with a discussion of issues of relevance to the treatment of a pregnant woman with MDD. It also describes the evidence based treatment provided and the results achieved for this client. The second report follows the same format to describe a case of PTSD in a married mother living in regional Australia following a suicide attempt. The third report describes a case of Bipolar I disorder in a separated mother living in regional Australia. Finally, fourth report explores the professional and ethical issues associated with the practice of clinical psychology [...]. This report explores professional issues which include self-care requirements and strategies, initial client contact, communication with colleagues and professional development and client records. Ethical issues covered include professional competency, termination of relationships and confidentiality."Doctor of Psychology (Clinical)
5
Meagher, Brendan. « Clinical placement reports and professional and ethical issues reports ». University of Ballarat, 2006. http://archimedes.ballarat.edu.au:8080/vital/access/HandleResolver/1959.17/14595.
Texte intégralRésumé :
"The first report describes a case of Major Depressive Disorder (MDD) in a pregnant women living in regional Australia. It begins with a discussion of issues of relevance to the treatment of a pregnant woman with MDD. It also describes the evidence based treatment provided and the results achieved for this client. The second report follows the same format to describe a case of PTSD in a married mother living in regional Australia following a suicide attempt. The third report describes a case of Bipolar I disorder in a separated mother living in regional Australia. Finally, fourth report explores the professional and ethical issues associated with the practice of clinical psychology [...]. This report explores professional issues which include self-care requirements and strategies, initial client contact, communication with colleagues and professional development and client records. Ethical issues covered include professional competency, termination of relationships and confidentiality."Doctor of Psychology (Clinical)
6
Mackenzie, Tania. « Reported responses to sexual trauma in people with intellectual disability : an analysis of clinical psychologists' psycho-legal reports ». Master's thesis, University of Cape Town, 2010. http://hdl.handle.net/11427/18425.
Texte intégralRésumé :
While a large body of literature suggests that rape and sexual assault in the general population is pathogenic, there is a dearth of literature on its impact on people with intellectual disability (ID). Several studies have reported that individuals with ID may experience a range of psychopathology following rape that is similar to that experienced by adults and children in the general population (i.e. PTSD, Major Depression) but with stronger behavioural reactions. The main aim of this research was to identify the response of individuals with ID who had experienced sexual trauma. This was an archival study of the Sexual Abuse Victim Empowerment (SAVE) project's clinical psychologists' notes and psycho-legal reports from 2005 – 2009 on 295 female, child and adult, sexual assault/rape survivors with ID. It was hypothesised that in the different PTSD symptom criteria clusters there would be more symptoms of increased arousal than re-experiencing and avoidance, that there would be a difference in the number of reported symptoms between different levels of ID, and between the number of symptoms reported by the different psychologists who assessed the sample. Includes bibliographical references (pages 65-73).
7
Moniz, Jennifer Lela. « Confusing Conversations : Assessing Traumatic Stress in Young Children ». Antioch University / OhioLINK, 2020. http://rave.ohiolink.edu/etdc/view?acc_num=antioch1587067693985147.
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8
Hawker, Mark David. « Health Watch : a management tool combining clinical and population data sets / ». Leeds : University of Leeds, School of Computer Studies, 2008. http://www.comp.leeds.ac.uk/fyproj/reports/0708/Hawker.pdf.
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9
Tinker, Jennifer Ruby Zillmer Eric. « Reported visual disturbance and post-concussion cognitive function in collegiate athletes : the relationship between symptom report and neurocognitive outcome / ». Philadelphia, Pa. : Drexel University, 2010. http://hdl.handle.net/1860/3264.
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10
Chung, Jeanhee 1972. « Concept-value pair extraction from semi-structured clinical reports : a case study using echocardiogram reports ». Thesis, Massachusetts Institute of Technology, 2004. http://hdl.handle.net/1721.1/28584.
Texte intégralRésumé :
Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2004.Includes bibliographical references (p. 38-39).
The task of gathering detailed patient information from narrative clinical text presents a significant barrier to clinical research. A prototype information extraction system was developed to extract pre-specified findings from narrative echocardiogram reports. The system which uses a Unified Medical Language System compatible architecture is very simple and takes advantage of canonical language use patterns to identify sentence templates with which concepts and their values can be identified. The data extracted from this system will be used to enrich an existing database used by clinical researchers in a large university healthcare system to identify potential research candidates fulfilling clinical inclusion criteria. The system was developed and evaluated using ten pre-determined clinical concepts. Concept-value pairs extracted by the system related to these ten conditions were compared with findings extracted manually by the author. The system was able to recall 78% of the relevant findings (CI, 76% to 80%), with a precision of 99% (CI, 98%-99%). Because data acquired from the system will ultimately be used in document and patient retrieval, preliminary analysis was done to evaluate document retrieval effectiveness. Median recall across the ten conditions was 36% (range, 0% to 93%). The system retrieved no documents for two of the ten conditions; median precision for the remaining eight conditions was 100% (range, 92% to 100%).
by Jeanhee Chung.
S.M.
11
Lindblad, Simon. « Labeling Clinical Reports with Active Learning and Topic Modeling ». Thesis, Linköpings universitet, Interaktiva och kognitiva system, 2018. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-148463.
Texte intégralRésumé :
Supervised machine learning models require a labeled data set of high quality in order to perform well. Available text data often exists in abundance, but it is usually not labeled. Labeling text data is a time consuming process, especially in the case where multiple labels can be assigned to a single text document. The purpose of this thesis was to make the labeling process of clinical reports as effective and effortless as possible by evaluating different multi-label active learning strategies. The goal of the strategies was to reduce the number of labeled documents a model needs, and increase the quality of those documents. With the strategies, an accuracy of 89% was achieved with 2500 reports, compared to 85% with random sampling. In addition to this, 85% accuracy could be reached after labeling 975 reports, compared to 1700 reports with random sampling.
12
Oliveira, Liliana Cristina Santos. « Curricular training report about clinical trials monitoring ». Master's thesis, Universidade de Aveiro, 2012. http://hdl.handle.net/10773/10578.
Texte intégralRésumé :
Mestrado em Biomedicina FarmacêuticaO presente relatório propõe-se a apresentar as atividades desenvolvidas durante um estágio curricular de 10 meses na Datamedica CRO Full Service. A estagiária encontrava-se a desenvolver atividades de monitorização de ensaios clínicos na empresa recetora pelo que este será o principal enfoque deste trabalho. Após 6 meses de estágio curricular, a Astellas Farma Lda subcontratou à Datamedica a estagiária em questão para desempenhar a função de CRA o que permitiu conhecer o mundo dos ensaios clínicos de duas diferentes perspetivas - a das grandes empresas da indústria farmacêutica e a das CROs (empresas subcontratadas pela indústria farmacêutica para desenvolver atividades específicas). Este trabalho tenta mostrar a visão obtida e os pontos de vista da estagiária enquanto monitora de ensaios clínicos das duas empresas. Para além da monitorização, foi possível desenvolver outras atividades em outros departamentos da Datamedica, nomeadamente realização de testes de legibilidade e atividades de medical writing que serão também apresentadas neste relatório. Este trabalho encontra-se dividido em dois principais capítulos sendo que o primeiro capítulo pretende situar a empresa de acolhimento na dinâmica da investigação clínica farmacêutica e dar a conhecer o estado da arte dos ensaios clínicos a nível europeu e nacional, com ênfase para a crise na investigação clínica em ambos os níveis. O segundo capítulo constitui a apresentação dos procedimentos que são seguidos em cada área de trabalho desenvolvida durante o período de estágio e a identificação de todas as atividades realizadas pela estagiária. O relatório termina com a discussão e conclusão de todo o trabalho desenvolvido e verificação dos objetivos de aprendizagem definidos no início do estágio. Todo o trabalho desenvolvido durante o estágio curricular e o contacto com os diversos profissionais envolvidos na área da investigação clínica foram fundamentais para a aquisição de competências sociais e intelectuais que contribuíram para o melhor desempenho da estagiária e a prepararam para o mundo profissional da indústria farmacêutica.
This paper intends to present the activities developed during a 10-month internship at Datamedica Full Service CRO. The trainee was developing clinical trial monitoring activities at the host company, which will be the main focus of this report. After 6 months of internship, Astellas Farma Lda subcontracted the trainee from Datamedica to be one of their CRA’s, providing her with an opportunity to experience the world of clinical trials from two different perspectives - the major pharmaceutical companies and the CROs (companies subcontracted by the pharmaceutical industry to develop specific activities). This report tries to show the point of view of the trainee as clinical trial monitor of the two companies. Besides clinical trial monitoring it was possible to develop different activities from other Datamedica departments such as the realization of readability tests and medical writing activities that will also be presented in this report. This paper is divided in two main chapters, where the first chapter goal is to place the host company dynamics in the pharmaceutical clinical research environment and provide some knowledge about the clinical trials state of the art nationally and internationally, highlighting the clinical research crisis that is threatening the pharmaceutical world at both levels. The second chapter presents the procedures followed with the different activities performed divided by area of work and the identification/specification of each activity developed by the trainee. The report ends with a discussion and conclusion about the work developed and the verification of the learning outcomes defined at the beginning of the internship. The work developed during this curricular internship and the contact network developed through the contact with a variety of professionals involved in the clinical research area were essential in the acquisition of social and intellectual skills that contributed to the best performance of the trainee during the internship and prepared her to the professional work environment of the pharmaceutical industry.
13
Simas, Ana Luísa Oliveira de. « Training report : clinical studies coordination in oncology ». Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/12966.
Texte intégralRésumé :
Mestrado em Biomedicina FarmacêuticaThis report describes a curricular training experience in Study Coordination, developed at Unidade de Investigação Clínica (Clinical Research Unit) of Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. (Portuguese Oncology Institute-Porto), in the ambit of the Master in Pharmaceutical Medicine at University of Aveiro. This report describes the State of the Art in Pharmaceutical R&D Process in Europe, especially in Oncology, emphasising its current trends and stressing specificities of special and vulnerable populations, in the scope of the traineeship. The study coordination activities were essentially performed in the Pathology Clinics of Lung, Urology, Gynaecology, Paediatrics, and the Intensive Care Service. The activities developed had the main goal of acquiring experience in oncology clinical trials, while reinforcing the knowledge from my academic background. These activities included screening and randomisation of patients, preparation and processing of study visits, data entry and query resolution, and documents management, among other activities transversal to the 15 clinical trials, accompanied in the traineeship. Globally, the traineeship allowed a good overview of the activities involved in the conduction of clinical trials in a hospital, and a worthy introduction to the marketplace. I strengthened the knowledge acquired from my academic background. I developed competences and skills at the professional and personal level, such as dealing with unforeseen situations, and developed strategies to overcome challenges. I sharpened my vision of careers in clinical research, and hope to continue addressing new challenges in this area.
14
Alves, André Ribeiro. « Curricular training report in clinical data management ». Master's thesis, Universidade de Aveiro, 2013. http://hdl.handle.net/10773/10875.
Texte intégralRésumé :
Mestrado em Biomedicina FarmacêuticaEste relatório descreve as actividades desenvolvidas no contexto do estágio de 9 meses realizado na Unidade de Gestão de dados da Eurotrials com inicio em Setembro de 2011 e fim em Maio de 2012. A Eurotrials é uma empresa de consultoria científica que presta serviços à indústria farmacêutica e biotecnologia, nomeadamente na condução de ensaios clínicos. No processo do desenvolvimento de um novo medicamento os ensaios clínicos são a ferramenta mais importante de forma a verificar a segurança e eficácia da substância. A gestão de dados cínicos tem um papel muito importante na condução de ensaios clínicos e tem como objectivo gerar dados de grande qualidade e robustos para que possam ser analisados. A equipa de gestão de dados participa em actividades que vão desde o planeamento do estudo até à sua conclusão. As principais actividades exercidas no âmbito da gestão de dados foram o desenho do caderno de recolha de dados, bem como a criação da base de dados, gestão de discrepâncias e padronização de dados.
This report describes the activities undertaken in the context of a Curricular training with a duration of 9 months in the Data Management Unit at Eurotrials starting in September 2011 and end in May 2012. Eurotrials is a contract research organization that provides services to the pharmaceutical and biotechnology industries, namely clinical trial conduction. In the drug development process, clinical trials are the most important tool to verify if the drug is secure and effective. The field of clinical data management has a very important role in clinical trials conduction and aims to generate high-quality and reliable data so that it can be analyzed. The data management team is engaged in activities ranging from the design of the study until their completion. The main activates performed regarding clinical data management were the design of the case report form, database design, discrepancies management and data standardization.
15
Morais, Catarina Manuel Souto. « Curricular training report at Blueclinical Ltd ». Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/13399.
Texte intégralRésumé :
Mestrado em Biomedicina FarmacêuticaThis report describes the activities I have developed and the knowledge I have acquired during my curricular training as Clinical Research Coordinator at Blueclinical – Investigação e Desenvolvimento em Saúde, Ltd. The curricular training is part of the second year of the Master’s Degree program in Pharmaceutical Biomedicine University of Aveiro. The main activity developed was the clinical trials coordination at Hospitalar Center Vila Nova de Gaia/Espinho, since the earliest phases – feasibilities – until latest phases – close-out visit. Nevertheless being part of a recent company, still in creation phase, was a positive aspect as it allowed me to perform a large variety of tasks, including management, creation of the quality system, among others. During the internship I was able to acknowledge the difficulties faced while creating and implementing a clinical research office, as well as acknowledge some differences between the academic environment and the professional environment. Besides the description of the activities developed and the objectives, this reports intents to contextualize the internship in Blueclinical’s structure and in clinical research state of art. It is also presented a critical analysis of the strengths, weakness, opportunities and threats faced during the curricular training.
Este relatório descreve as atividades que desenvolvi e as aprendizagens que adquiri durante o meu estágio curricular, enquanto Coordenadora de Investigação Clínica na Blueclinical – Investigação e Desenvolvimento em Saúde, Lda. O estágio curricular foi realizado no âmbito do segundo ano do Mestrado de Biomedicina Farmacêutica da Universidade de Aveiro. A principal atividade desenvolvida foi a coordenação de ensaios clínicos no Centro Hospitalar Vila Nova de Gaia/Espinho, desde as fases mais iniciais do seu desenvolvimento – questionários de exequibilidade – até às fases mais tardias – visita de fecho. No entanto, pertencer a uma empresa ainda em processo de criação foi uma mais-valia pela pluralidade das tarefas efetuadas, incluindo tarefas relacionadas com gestão, criação do sistema de gestão de qualidade, entre outras. Durante o estágio foi-me possível tomar conhecimento das dificuldades encontradas durante a criação e implementação de um Gabinete de Investigação Clínica e também aperceber-me de algumas diferenças entre o mundo académico e o mundo profissional. Para além da descrição das atividades desenvolvidas e dos objetivos que me propôs a atingir, este relatório tenta contextualizar o estágio na estrutura da Blueclinical e no estado de arte da investigação clinica. É também apresentada uma análise crítica dos pontos fortes, pontos fracos, dificuldades e oportunidades encontrados durante o estágio.
16
Granja, Joana Fernanda Durães Barbosa. « Curricular training report at Blueclinical, LTD ». Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/23514.
Texte intégralRésumé :
Mestrado em Biomedicina FarmacêuticaO presente relatório descreve com detalhe o meu período de estágio curricular realizado durante o Mestrado em Biomedicina Farmacêutica. O estágio teve a duração de 9 meses e ocorreu na Blueclinical Lda., uma empresa constituída por três unidades de negócio distintas: Unidade de Fase I, Unidade de Investigação e Desenvolvimento e uma Unidade de Parceria com Centros de Ensaio - Clinical Research Partnership (CRP). A minha atividade foi desenvolvida apenas numa unidade de negócio – CRP. No entanto tive oportunidade de conhecer duas realidades distintas, exercendo funções num centro de ensaio como coordenadora de ensaios clínicos e funções na Blueclinical Back Office, com funções de apoio à unidade CRP, essencialmente na gestão de contratos financeiros e pagamentos. Neste relatório é revisto o estado de arte da investigação clínica e são descritas as principais atividades realizadas durante o estágio. São igualmente relatadas, as principais dificuldades sentidas, as estratégias utilizadas para as ultrapassar e objetivos que considero alcançados. A realização deste estágio foi uma excelente oportunidade que me permitiu consolidar os conteúdos teóricos adquiridos durante o primeiro ano do mestrado, obtendo a experiência necessária para ingressar no mundo de trabalho da Investigação Clínica.
The present report describes in detail my internship period, during the Master in Pharmaceutical Medicine. The internship lasted 9 months and was performed in Blueclinical Ltd., a company that has three business units: Phase I Unit, Research and Development Unit and Clinical Research Partnership Unit (CRP). My activities were performed in only one business unit - CRP, however I had the opportunity to experience two different realities, exercising functions as Clinical Research Coordinator at site and support functions at Blueclinical Back office, mainly contract management and payment tracking. This report reviews state of art of clinical research and describes main activities performed during internship. Along with the description of the activities performed, it is done a presentation of the difficulties encountered, strategies used to overcome them and objectives I considered achieved. This internship was a great opportunity that allowed me to consolidate theoretical knowledge acquired during the first year of the master, giving me the necessary experience to cross into Clinical Research job market
17
Plunkett, Alicia Renee'. « The Use of a Standardized System of Communication to Change the Perception of Handoff Communication in a Psychiatric Setting ». ScholarWorks, 2015. https://scholarworks.waldenu.edu/dissertations/200.
Texte intégralRésumé :
The Use of a Standardized System of Communication to Change the Perception of Handoff Communication in a Psychiatric Setting
by
Alicia Renee' Plunkett
MSN, Walden University 2007
MSHA, University of St. Francis, 2005
BSN, University of Memphis, 1995
Project Submitted in Partial Fulfillment
of the Requirements for the Degree of
Doctor of Nursing Practice
Walden University
December 2014
The Joint Commission's review of sentinel events indicated that communication errors were the cause of over 65% of the sentinel events occurring in healthcare. The nursing profession has the responsibility of providing 24-hour care in an acute care setting and nurses are thus the primary participants in the handoff communication process. The purpose of this project was to assess the nursing staff's perception of handoff and to create a process for handoff communication. The most common framework for correcting communication errors in the literature is the Situation, Background, Assessment, and Recommendation framework, which was used as a guide for developing a process and form for handoff in this facility. The "Clinical Handover Staff Survey" developed by O'Connell, MacDonald, and Kelly (2008) was modified for use in this study. This survey was distributed to nurses and mental health technicians in 2 acute care units within a standalone acute care psychiatric hospital (n = 140). The quantitative survey identified 3 common barriers to the process in this facility that included: (a) interruptions, (b) subjective terminology used to describe patients, and (c) the lack of confidence in the information presented. After the implementation of a new process and form, the staff members were resurveyed to measure their post implementation perceptions of the handoff process. In each of the 3 areas measured, the implementation of a new process and form allowed the facility to see changes in the staffs' perceptions of the handoff process. The changes seen in this facility further indicate the need for education, standardization, and a continued focus on improving and mastering the important task of handoff communication. Improving handoff communication prevents errors in patient care from occurring, therefore decreasing mortality and morbidity rates.
18
Santos, Ana Teresa Martins Sousa. « Report on training in a clinical research centre ». Master's thesis, Universidade de Aveiro, 2012. http://hdl.handle.net/10773/10486.
Texte intégralRésumé :
Mestrado em Biomedicina FarmacêuticaA crescente exigência de pesquisa científica, das agências reguladoras e a necessidade de maximizar a segurança dos participantes têm requerido uma gestão mais eficiente, capaz e precisa para realizar estudos de alta qualidade de pesquisa clínica e melhorar a competitividade neste campo. Para enfrentar este desafio, centros de pesquisa clínica tem surgido para apoiar os requisitos operacionais, metodológicos e regulamentares. Este trabalho relata a minha experiência de Setembro 2011 a Junho de 2012 num centro de investigação clínica como coordenadora e co-monitora de ensaios clínicos e estudos observacionais na Unidade Neurológica de Investigação Clínica do Instituto de Medicina Molecular, as atividades de farmacovigilância realizados numa unidade regional do Sistema de Farmacovigilância Português e as tarefas de gestão científica desenvolvidas envolvendo estas duas unidades. Como um estágio curricular com objetivo de colocar em prática os conceitos aprendidos no primeiro ano de mestrado em Biomedicina Farmacêutica, tive a oportunidade de experimentar diferentes papéis ligados à investigação clínica e compreender as responsabilidades e expectativas envolvidas em cada um deles. Este estágio curricular deu-me uma visão realista de um centro de investigação clínica, bem como as interações entre os diferentes profissionais.
The growing demand of scientific research, regulatory agencies and the need to maximize participant safety have required efficient, capable and precise management to conduct high-quality clinical research studies and improve the competitiveness in this field. To face up to this challenge, clinical research centers have emerged to support the operational, methodological and regulatory requirements. This work reports on my experience since September 2011 until June 2012 in a clinical research centre coordinating and monitoring the clinical trials in the Neurological Clinical Research Unit of Instituto de Medicina Molecular, the Pharmacovigilance activities performed in a regional unit of the Portuguese Pharmacovigilance System and the Science Management tasks developed involving these two units. As a curricular internship aimed to put into practice the concepts learnt in the first year of master’s degree in Pharmaceutical Biomedicine, I had the opportunity to experience different roles linked to the clinical research and realize the responsibilities and expectations involved in each one of them. This curricular training provided a realistic vision of a clinical research center as well as the interactions between different professionals.
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Ferreira, Adriana Filipa da Silva. « Curricular training report : clinical trials coordination in neurology ». Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/21557.
Texte intégralRésumé :
Mestrado em Biomedicina FarmacêuticaO presente relatório descreve as atividades desenvolvidas durante o estágio curricular como coordenadora de investigação clínica, que teve lugar na Unidade de Farmacologia Clínica do Instituto de Medicina Molecular e decorreu de Setembro de 2014 a Junho de 2015. A principal atividade desempenhada durante este estágio foi a coordenação de ensaios clínicos na área da neurologia, nomeadamente ensaios de fase II, III e IV. Foram desenvolvidas outras atividades, tais como gestão de dados clínicos, atividades de farmacovigilância e escrita científica e monitorização de estudos clínicos, com vista a complementar a formação curricular. Neste relatório é, também, apresentada uma breve contextualização do estado de arte do processo de Investigação & Desenvolvimento de novos medicamentos, tendências atuais e especificidades do desenvolvimento de medicamentos na área da neurologia. Para além disso são abordadas as dificuldades sentidas durante o estágio e as estratégias utilizadas para as ultrapassar, bem como a visão pessoal sobre o papel do coordenador de investigação clínica na condução de ensaios clínicos. Globalmente, a realização deste estágio curricular traduziu-se na oportunidade de aplicar e aprofundar os conhecimentos e competências adquiridos ao longo do percurso académico, em especial no Mestrado em Biomedicina Farmacêutica, e de desenvolver competências e aptidões, tanto a nível profissional como pessoal, fulcrais para um profissional de investigação clínica. Em conclusão, este estágio constituiu uma introdução à prática da investigação clínica.
This report describes the activities developed during the curricular training as coordinator of clinical research, which took place in the Unidade de Farmacologia Clínica of the Instituto de Medicina Molecular and was held from September 2014 to June 2015. The main activity performed during this training was the coordination of clinical trials in the field of neurology, mainly phase II, III and IV clinical trials. Other activities, such as data management, pharmacovigilance, medical writing and monitoring of clinical studies, were developed to complement the training. This report also presents a brief background of the state of the art of the Research & Development process of new drugs, current trends and specificities of the drug development in neurology. Furthermore, it addresses the difficulties experienced during the training and the strategies used to overcome them, as well as a personal insight on the role of the clinical research coordinator in conducting clinical trials. Overall, achieving this curricular training resulted in the opportunity to apply and deepen the knowledge and skills acquired throughout the academic career, especially in the Masters in Pharmaceutical Biomedicine, and to develop skills and abilities, at professional and personal level, central to a professional of clinical research. In conclusion, this training was an introduction to the practice of clinical research.
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Swaminathan, Sindhia. « Relationships between symptoms and adaptive functioning in clinic-referred adolescents : Patterns of internalizing, externalizing, and co-occurring symptoms ». Bowling Green State University / OhioLINK, 2016. http://rave.ohiolink.edu/etdc/view?acc_num=bgsu1457534784.
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Correia, Márcia Sofia Barbosa. « Internship report in clinical studies coordination at IPO-Porto ». Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/12949.
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Mestrado em Biomedicina FarmacêuticaThis report describes my activities as study coordinator (SC) intern, at the “Unidade de Investigação Clínica” (UIC) in the Oncology Portuguese Institute of Porto (IPOP). This training occurred during the second year of the Pharmaceutical Biomedicine Master at the University of Aveiro. My internship took place between 21st January, 2013 and 4th October, 2013 with the main objective to gain experience and expertise in oncology coordinating clinical trials. I present the state-of-the-art of clinical research with emphasis on current situation in Portugal as well as in oncology. At the beginning of internship I performed generic training in Good Clinical Practices (GCP) and Electronic Data Capture systems and familiarised myself with terminology and classification/assessment systems regarding the oncology area to support the clinical trial coordination activities in the context of the oncology protocols. In UIC, I participated in 6 phase II and 25 phase III clinical trials of 9 clinics of pathology: Urology, Gynaecology, Digestive, Lung, Soft Tissue and Skin, Head and Neck, Onco-Haematology, Breast and Paediatry. Within of these clinics, I intensively participated and acquired more autonomy in clinical trials of the Digestive pathology. The Onco-Haematology clinic includes the more complex procedures of the clinical trials protocols. As SC, I could intensively participate in the conduction clinical trial activities, namely: Randomisation Period, including Screening and Randomisation of patients, Clinic Visits and Monitoring Visits. The experience gained during my curricular internship was very enriching and enabled me to acquire professional and interpersonal skills and competences and to face unexpected situations, developing strategies to deal with them. Additionally, it was possible to consolidate and apply the theoretical knowledge acquired during Master Course in Pharmaceutical Medicine at different stages of clinical trials coordination. In conclusion, during my curricular internship, I gathered the competences, motivation and experience to pursue a career in clinical research, particularly, as SC.
Este relatório descreve as actividades como coordenadora de estudos estagiária, na Unidade de Investigação Clínica (UIC) do Instituto Português de Oncologia do Porto (IPOP). Este estágio foi parte integrante das actividades curriculares do segundo ano do Mestrado em Biomedicina Farmacêutica da Universidade de Aveiro. O estágio decorreu entre 21 de Janeiro de 2013 e 4 de Outubro de 2013, com o principal objectivo em adquirir experiência e especialização na coordenação de ensaios clínicos em oncologia. No documento é apresentado o estado de arte de arte da investigação clínica com ênfase na actual situação em Portugal bem como em oncologia. Na fase inicial do estágio realizei treino genérico em Boas Práticas Clínicas e sistemas de Captura de Dados Electrónicos e familiarizei-me com terminologia e sistemas classificação/avaliação próprios da área de oncologia para suportar as actividades de coordenação de ensaios clínicos no contexto dos protocolos de oncologia. Na UIC, participei em vários estudos de fase II e III de 9 clínicas de patologia: Urologia, Ginecologia, Digestivos, Pulmão, Pele e Tecidos Moles, Cabeça e Pescoço, Onco-Hematologia, Mama e Pediatria. Dentro destas clínicas, participei intensivamente e adquiri mais autonomia nos ensaios clínicos da patologia de Digestivos. A clínica de Onco-Hematologia, agrega os protocolos de ensaios clínicos com procedimentos mais complexos. Como coordenadora de ensaios clínicos pude participar intensivamente nas actividades de condução de um ensaio clínico, nomeadamente: Período de Randomização incluindo Rastreio e Randomização de doentes, Visitas Clínicas e Visitas de Monitorização. A experiência adquirida ao longo do estágio curricular foi muito enriquecedora e permitiu-me adquirir capacidades e competências profissionais e interpessoais e aprender a enfrentar situações inesperadas, desenvolvendo estratégias para lidar com as mesmas. Para além disso possibilitou-me a consolidar e aplicar os conhecimentos teóricos adquiridos no Curso de Mestrado nas diferentes fases de coordenação dos estudos. Em conclusão, ao longo do estágio adquiri competências, motivação e experiência para enveredar por uma carreira na área de investigação clínica, especialmente como Coordenadora de Ensaios Clínicos.
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Lemos, João Filipe Carvalho. « Internship report as associated project manager at Blueclinical ». Master's thesis, Universidade de Aveiro, 2013. http://hdl.handle.net/10773/13133.
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Mestrado em Biomedicina FarmacêuticaThe present curricular report describes the activities that I performed as an associate project manager at Blueclinical, Lda a portuguese company that develops its activities in the research and development of health’s. As I mostly worked with medical devices, in this report there is a brief review of the state of the art about this area giving emphasis to the portuguese case. During the 9 months of the internship, I had the opportunity of completing my academic formation with some training and training which are mentioned. Concerning the specific training, the activities related to the medical devices area and phase I clinical studies are described as well as the activities that I performed as a clinical study coordinator. Additionally, there are other activities mentioned, such as SOP’s writing and the study of QREN legislation. Following that, there is a final discussion about the difficulties felt and what was learnt during the internship. The report ends with a conclusion/reflexion about this curricular internship.
Este relatório de estágio descreve as atividades que desenvolvi enquanto gestor de projeto associado na Blueclinical, Ltd, companhia portuguesa que desenvolve atividade na Investigação e desenvolvimento na saúde. Como a minha principal área de trabalho foram os dispositivos médicos, este relatório faz uma curta revisão do estado da arte nesta área com enfâse no caso português. Nos 9 meses de estágio, tive a oportunidade de completar a minha formação com algumas formações e treinos, que são também referidos. Na formação específica, são descritas as atividades relacionadas com a área dos dispositivos médicos, com os ensaios clínicos de fase I e as atividades como coordenador de estudos clínicos. Para além destas também são referidas outras atividades como por exemplo a escrita de SOPs, ou o estudo da legislação do QREN. Segue-se uma discussão geral sobre as dificuldades sentidas e o que aprendi durantes este período. O relatório termina com uma conclusão/reflexão sobre este estágio curricular.
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Sousa, Joana Cristina Mendes Cruz de. « Training report in clinical trials coordination at Blueclinical, LTD ». Master's thesis, Universidade de Aveiro, 2016. http://hdl.handle.net/10773/17158.
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Mestrado em Biomedicina FarmacêuticaThis report describes the activities performed as clinical research coordinator, during the internship of the Master in Pharmaceutical Medicine, at the University of Aveiro. The curricular internship took place at Blueclinical – particularly at Centro Hospitalar de Vila Nova de Gaia/Espinho, from 15th September 2015 to 15th April 2016. The report is divided into seven chapters. The training objectives are presented in the two chapter, and in the next chapter the host institutions are characterized. Then, in the four chapter it is presented the state-of-the-art of the pharmaceutical research and development process, including the current situation of the clinical trials in Portugal. The activities carried out under the scope of the clinical trials coordination are described in five four. In the last chapters, it is performed a critical analysis and the assessment of the internship, and are also mentioned the strategies adopted in order to solve the problems and difficulties that arose. In conclusion, I consider that the internship fulfilled its purpose, providing the acquisition of skills as clinical research coordinator.
Este relatório descreve as atividades desenvolvidas como coordenadora de ensaios clínicos no âmbito do estágio curricular do Mestrado em Biomedicina Farmacêutica, lecionado na Universidade de Aveiro. O estágio curricular decorreu no Centro Hospitalar de Vila Nova de Gaia/Espinho, no período compreendido entre 15 de setembro de 2015 e 15 de abril de 2016. O relatório encontra-se estruturado em sete capítulos, sendo que no segundo capítulo são mencionados os objetivos do estágio, procedendo-se no capítulo seguinte à caracterização das instituições acolhedoras. Posteriormente, no capítulo quatro é apresentado o estado de arte do processo de investigação e desenvolvimento farmacêutico, incluindo a caraterização da situação atual dos ensaios clínicos em Portugal. As atividades realizadas no âmbito da coordenação de ensaios clínicos estão descritas no capítulo cinco. Nos últimos capítulos, analisa-se e procede-se à avaliação do estágio, sendo também mencionadas as estratégias adotadas para solucionar os problemas e dificuldades que foram surgindo. Em suma, considero que o estágio curricular cumpriu a sua finalidade, ao possibilitar a aquisição de competências como coordenadora de investigação clínica.
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VIANI, NATALIA. « Information Extraction from Medical Reports in the Italian Language for Clinical Timelines Reconstruction ». Doctoral thesis, Università degli studi di Pavia, 2018. http://hdl.handle.net/11571/1214892.
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Electronic health records represent a great source of valuable information for both patient care and biomedical research. Despite the efforts put into collecting structured data, a lot of information is available only in the form of free text. For this reason, developing systems that automatically extract relevant information from clinical narratives is essential. In addition, summarizing all the data related to one single patient represents an essential task.
In the field of clinical information extraction, several systems have been developed, especially for the analysis of texts written in English. However, the related research for non-English languages is still limited. In this research activity, information extraction techniques and summarization methods were applied to the analysis of medical reports written in Italian. For this language, shared resources for clinical information extraction are not easily available. In this work, a corpus of molecular cardiology reports was considered as the main dataset for methods development. Moreover, to enable the design and the evaluation of different approaches, a subset of this corpus was annotated by manually identifying the information to be extracted from the texts.
To access the knowledge included in textual medical reports, a first step involves the identification of clinical events. In the natural language processing community, this task is often addressed by using supervised methods. In this research activity, two different approaches were exploited to perform event extraction. First, a simple, yet effective approach based on dictionary lookup was used. Second, an application of recurrent neural networks was investigated.
In clinical texts, events are often mentioned together with relevant attributes that have to be extracted to characterize the event itself. In this thesis, an ontology-driven approach was used to identify events’ attributes in the cardiology reports. In particular, a domain-specific ontology was manually developed, including all the relevant events with their associated attributes. As the gold standard for the evaluation phase, a hospital database, which stores most of the information written in the reports, was exploited.
As another important task, to correctly reconstruct patients’ clinical histories, it is necessary to assign a specific time to each event extracted from the text. To this end, the identification of temporal expressions is a first, mandatory step. In this research activity, two existing rule-based systems for temporal information extraction were adapted to the analysis of clinical narratives.
To process each document, the three illustrated steps (event, attribute, and time expression extraction) were aggregated into a pipeline. As an important remark, for each event and temporal expression identified in the text, the pipeline extracts a few properties of interest, too. Among these properties, the temporal relation between each event and the document creation time is computed (DocTimeRel). On the basis of this relation, each event is further linked to a reference time by applying a set of hand-crafted rules.
Besides processing single medical reports, the system developed in this research activity is able to summarize multiple documents referred to the same patient. In this case, the information extraction pipeline is initially run on all the documents belonging to that patient. Then, the system builds and visualizes a timeline of all the extracted events, exploiting the DocTimeRel information and the event-time links.
As regards the system’s evaluation, the overall information extraction pipeline performed well on the considered Italian cardiology corpus. In addition, the possibility to adapt the attribute extraction step to the analysis of another language was assessed, with promising results. In a similar way, the developed ontology was adapted to the analysis of another clinical domain, leading to a well-performing system.
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Valente, Vanessa Sofia Silva. « Curricular training report as a clinical research coordinator in Blueclinical Ltd ». Master's thesis, Universidade de Aveiro, 2016. http://hdl.handle.net/10773/16505.
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Mestrado em Biomedicina FarmacêuticaThis report describes the activities developed within the curricular internship as a clinical research coordinator in the Clinical Research Partnership business area of Blueclinical. The internship lasted 10 months – from July 2014 until April 2015. This report provides a general view of the implementation of clinical trials and observational studies in clinical research centers alongside with my experience during the 10 months of curricular internship as a clinical research coordinator in Centro Hospitalar de Vila Nova de Gaia/Espinho. To understand the regulations under which my activities were developed, clinical research is contextualized in what regards it’s legal and ethical framework and the evolution of the number of clinical trials in Portugal along the last years. In the overall result, I have experienced a great improvement in understanding the coordination of clinical trials and observational studies, as well as the improvement of my soft skills.
O presente relatório descreve as atividades desenvolvidas no âmbito do estágio curricular como coordenadora de investigação clínica na área de negócio “Clinical Research Partnership” da Blueclinical. O estágio curricular teve a duração de 10 meses – Julho de 2014 a Abril de 2015. Este relatório fornece uma visão geral da implementação de ensaios clínicos e estudos observacionais em centros de investigação clínica em paralelo com a minha experiência durante os 10 meses de estágio curricular como coordenadora de investigação clínica no Centro Hospitalar de Vila Nova de Gaia/Espinho. Para permitir a compreensão das normas segundo as quais a minha atividade foi desenvolvida, é feita uma contextualização da investigação clínica no que respeita ao enquadramento legal, ético e evolução do número de ensaios em Portugal ao longo dos últimos anos. No cômputo geral, experimentei uma grande melhoria na compreensão da coordenação de ensaios clínicos e estudos observacionais, assim como a nível de “soft skills”.
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TOMODA, YUTAKA, HIROSHI SAKAIDA, SETSUKO GOTO, SEIJI NOMURA, TORU NAKANISHI et TOMOMITSU OKAMOTO. « An Unusual Clinical Course after Mole Evacuation : A Case Report ». Nagoya University School of Medicine, 1997. http://hdl.handle.net/2237/16752.
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Rozhko, V. I. « Case report : clinical result of revascularization of a permanent tooth ». Thesis, БДМУ, 2021. http://dspace.bsmu.edu.ua:8080/xmlui/handle/123456789/19129.
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Araújo, Isabel Cristina Fontes Almeida Sousa. « Report of training in clinical trials coordination in a hospital ». Master's thesis, Universidade de Aveiro, 2012. http://hdl.handle.net/10773/10585.
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Mestrado em Biomedicina FarmacêuticaEste relatório descreve as minhas actividades como coordenadora de estudos estagiária, durante 9 meses, no serviço de neurologia do Centro Hospitalar de Entre o Douro e Vouga, em Santa Maria da Feira. Este estágio foi parte integrante das actividades curriculares do segundo ano do Mestrado em Biomedicina Farmacêutica da Universidade de Aveiro. Este estágio permitiu-me desenvolver capacidades de coordenação de ensaios clínicos e estudos observacionais, bem como outras actividades de investigação desenvolvidas, incluindo preenchimento de bases de dados de estudos nacionais e internacionais, participação em projectos de longa duração e artigos científicos. Para além destas actividades, tive também a oportunidade de participar na validação de um questionário de qualidade de vida para a população portuguesa que sofre de Hipertensão Pulmonar, no Hospital de Santo António, no Porto. Os conhecimentos adquiridos ao longo de todo o meu percurso académico (licenciatura em Ciências Biomédicas e Mestrado em Biomedicina Farmacêutica) foram extremamente úteis para o desenvolvimento das actividades que me foram propostas e a integração no mercado do trabalho.
This report describes my activities as study coordinator intern, during nine months, in the neurology service of Centro Hospitalar de Entre o Douro e Vouga, in Santa Maria da Feira. This training occurred during the second year of the Pharmaceutical Biomedicine Master at the University of Aveiro. This training allowed me develop abilities in coordination of clinical trials and observational studies, as well as perform other research activities developed in the neurology service, including filling in of national and international databases of studies, participation in long duration projects and scientific articles. Beyond that, I also had the opportunity to participate in the validation of a quality of life questionnaire for Portuguese population with pulmonary arterial hypertension, in the Hospital Santo António, Porto. My background knowledge was useful to develop the activities proposed in the training and to my integration in the working market.
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Merikle, Elizabeth Paige 1965. « Development of a self-report measure of drug craving ». Diss., The University of Arizona, 1997. http://hdl.handle.net/10150/289233.
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The construct of craving is frequently invoked as a causal factor in on going substance use or in relapse after a period of abstinence. The aim of the present study is to develop a general self-report questionnaire of craving that can be used to assess craving at any point in addiction and recovery. The study was conducted in two phases. In the first phase of the study a sample of 23 addicts were interviewed about their subjective experience of craving. The purpose of this phase of the study was to develop a theory of the subjective experience of craving that could be used to guide the development of the self-report questionnaire. Analysis of the text of these interviews revealed nine dimensions of the subjective experience of craving: specificity, strength, positive outcomes, behavioral intention, physical symptoms, affect, internal cues, situations, and drug availability. The first six dimensions were hypothesized to load on a general craving factor, and the last three dimensions were hypothesized to load on a cue reactivity factor. Questionnaire items were generated to broadly sample each of these dimensions. In the second phase the questionnaire was administered to a heterogenous sample of 205 addicts. Confirmatory factor analytic procedures were used to assess the present theory of craving and the psychometric properties of the instrument. The two factor model of craving fit the data well based on practical fit indices (Robust CFI =.95) and the discriminant validity of the two factors was supported. These analyses supported the theory of craving underlying the development of the questionnaire and indicated that the questionnaire has acceptable psychometric properties. The theoretical, psychometric, and clinical implications of the results are discussed.
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Zelechoski, Amanda Dovidio Goldstein Naomi E. Sevin. « The content of child custody evaluation reports : a forensic assessment principles-based analysis / ». Philadelphia, Pa. : Drexel University, 2009. http://hdl.handle.net/1860/3025.
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Vallabh, Sheetal. « Towards being heard : representations of the child's voice in custody evaluation reports by the Family Advocate's Office ». Master's thesis, University of Cape Town, 2009. http://hdl.handle.net/11427/14061.
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Includes bibliographical references (leaves 71-81).This study outlined the changing social and legal contexts insofar as it relates to children's participation in matters that affect their lives. It set out the debates in the literature on whether not children should participate in family law matters, specifically custody disputes, and if so, how this participation should take place. It also drew upon research studies which have explored directly children's views on the issue. The challenges involved in custody evaluations were scrutinised, specifically in relation to the Family Advocate's Office, and alternative and/or complementary methods of accessing the child's voice were considered. In South Africa, in all access and/or custody disputes, the Family Advocate’s Office is tasked with making recommendations to the court, which are in the child's best interest. The recently promulgated provisions of the Children's Act (2005) also require that the child's views and wishes be taken into consideration. Accordingly, this research study involved a thematic content analysis of 10 Family Counsellor reports, in order to determine how the child's voice is accessed by the Family Advocate's Office. A structural model illustrating how the child's voice was represented in the reports was developed. It showed that the child's voice was represented in three distinct ways, namely: the child's voice is accessed directly; the child's voice is disqualified; and the archetypal child's voice is accessed through a proxy. The findings showed a tendency to rely more on accessing the archetypal child's voice through a proxy, which typically included reporting that was less descriptive and more inferential, interpretive and opinion-laden. A need for more direct, non-disqualified means of accessing and/or reporting on the child's views and wishes was indicated.
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Moreira, Paula Cristina Leão. « Internship report on Blueclinical phase I unit ». Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/13413.
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Mestrado em Biomedicina FarmacêuticaBioavailability/Bioequivalence clinical trials are a promising area in Pharmaceutical R&D and it is very interesting being involved in this field. During the internship, I practiced assistance activities to Bioavailability/Bioequivalence clinical trials and this was my target for intervention within Blueclinical during ten months. During this time I also had opportunity to exercise nursing research activities due to my previous training in the area. This report aims to describe the activities in which I was involved, the learning points and the experience achieved about the conduction of Bioavailability/Bioequivalence clinical trials. During the internship I have developed clinical trial assistance activities and I learned a lot about the process of trial conduction, from the submission to the authorities to get their approvals until the process of reporting the results This job was a challenge and a continuous learning process. At the end of this period, I feel it was a rewarded effort and I would like to keep developing my skills in this area.
Ensaios clínicos de Biodisponibilidade/Bioequivalência são uma área promissora em I&D Farmacêutico, e é muito interessante estar envolvida neste âmbito. Durante o estágio pratiquei atividades de assistência a ensaios clínicos de Biodisponibilidade/Bioequivalência sendo este o meu alvo de intervenção na Blueclinical durante dez meses. Durante este tempo também tive oportunidade de exercer atividades de enfermagem de investigação devido à minha formação anterior na área. Este relatório tem como objetivo descrever as atividades em que estive envolvida, os pontos de aprendizagem e a experiência adquirida em relação à condução de ensaios clínicos de Biodisponibilidade/Bioequivalência. Durante o estágio desenvolvi atividades de assistência de ensaios clínicos e aprendi muito sobre o processo de condução do ensaio, desde a submissão do ensaio junto das autoridades para obter a sua autorização até ao processo de relatar os resultados. Este trabalho foi um desafio e um processo de aprendizagem contínua. No final desta etapa, sinto que foi um esforço recompensado e desejo continuar a desenvolver as minhas capacidades nesta área.
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Silva, Pedro Miguel Couto Moreira e. « Curricular trainig report as study coordinator in Blueclinical Ltd ». Master's thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/15798.
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Mestrado em Biomedicina FarmacêuticaThe present report describes in detail the activities and knowledge aquired during my internship as study coordinator in Blueclinical – Investigação e Desenvolvimento em Saúde, Ltd., in order to obtain the master degree in Pharmaceutical Biomedicine. According to the type of services provided, Blueclinical is formed by three business units: Blueclinical Clinical Research Partnership, Blueclinical Phase I and Blueclinical Research and Development. The fact of belonging to such a company gave me the opportunity to be in touch with different areas of pharmaceutical development and to contact with different research teams, which for me was an added advantage to the integration and consolidation of knowledge, as well as in the development and improvement of soft and hard skills. The main activity developed was the coordination of clinical studies, in Unidade Local de Saúde de Matosinhos, E.P.E., which was one of the institutions that established a partnership with Blueclinical, Ltd. During my internship I was able to contact with various stages of development and coordination of clinical trials, which will be reported in this report.
O presente relatório descreve com detalhe as atividades e aprendizagens adquiridas no âmbito do meu estágio curricular como coordenador de estudos na Blueclinical, Lda., para obtenção do grau de mestre de Biomedicina Farmacêutica. De acordo com o tipo de serviços prestados, a Blueclinical pode ser dividida em três unidades de negócio: Blueclinical Clinical Research Partnership, Blueclinical Phase I e Blueclinical Research and Development. O facto de pertencer a esta companhia deu-me a oportunidade de estar em contacto com diferentes áreas do desenvolvimento farmacêutico e de contactar com diferentes equipas de investigação, o que para mim foi uma vantagem para a integração e consolidação de conhecimento, bem como para o desenvolvimento de hard e soft skills. A principal atividade desenvolvida foi a coordenação de estudos clínicos, na Unidade Local de Saúde de Matosinhos, E.P.E., que se insere na rede de hospitais que estabeleceram parceria com a Blueclinical, Lda. Durante o meu estágio pode contactar com diversas fases de coordenação e desenvolvimento de ensaios clínicos, que serão relatadas nesta dissertação.
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Nguyen, Hoang Minh Dung. « Information Extraction from Radiology Reports for a Population Based Cancer Registry ». Thesis, The University of Sydney, 2013. http://hdl.handle.net/2123/9466.
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In a noisy corpus such as in clinical data, the text usually contains a large number of misspell words, abbreviations and acronyms that can be an obstacle to high quality information extraction and classification. Furthermore, the gold-standard training data needed for supervised learning usually contains many errors and inconsistencies due to differences in human annotators. In this research, a specialised proof-reading process for the clinical domain to resolve unknown tokens and convert scores and measures into a standard layout is introduced. The automatic coding of the texts increased the coded content significantly after the automatic correction process. Accuracy of the automatic coding and annotation of the notes which have not been coded by the clinical staff is suggested by the system output. To deal with the problem of noisy training data, this thesis proposes an algorithm for a method named “reverse active learning” which means applying active learning in reverse order to improve performance of supervised machine learning on clinical corpora. The effects of automatic proof-reading and reverse active learning are shown to produce results on the i2b2 2010 clinical corpus that are a state-of-the-art of supervised learning method and offer a means of improving all processing strategies in clinical language processing. Finally, a Cancer Staging Information Extraction System based on the combination of proposed methods of proof-reading, supervised learning, active learning and reverse active learning is presented. In this research, free-text reports are annotated for examples of the information to be extracted and then algorithms are developed that use the examples to compute a more general model of the desired content. Besides traditional supervised learning methods such as Conditional Random Fields and Support Vector Machines, active learning approaches are investigated to bring further improvement to information extraction system performance.
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Oliveira, Joana Pereira. « Curricular training report : clinical studies coordination in a clinical research organization vs an investigational site perspective ». Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/15780.
Texte intégralRésumé :
Mestrado em Biomedicina FarmacêuticaThis report describes my experience of nine months as a trainee of a CRO (Eurotrials, Scientific Consultants), as well as a trainee of a clinical research site (Clinical Academic Center – Braga, Association). This document describes the European framework about clinical research and the Portuguese situation compared to similar countries. The activities developed during this internship are also described. These activities are divided in two phases. The first one occurred in Eurotrials, Scientific Consultants, a CRO specialized in clinical research and scientific advice. The first weeks were dedicated to intensive self-training needed to perform CTA tasks. These tasks included qualification, initiation and monitoring activities related to clinical trials, as well as the development of a quality management system. The second phase took place on 2CA-Braga, a clinical research center located in Hospital of Braga. Clinical studies coordination was the main focus of this second phase of my internship, as well as negotiation of clinical studies agreements. I had also the opportunity to participate in “1as Jornadas de Investigação Clínica e Inovação” (1st Clinical Investigation and Innovation Conference) organized by 2CA-Braga. Globally, this internship was a great opportunity to get knowledge and experience in the implementation and management of clinical trials, in a CRO and clinical research site perspectives. These two perspectives provided an interesting overview about the scientific needs of different players involved in clinical research. To conclude, this internship strengthened the knowledge acquired from my academic background, which make me able to face and overcome new challenges in the clinical research area.
Este relatório descreve a minha experiência de nove meses enquanto estagiária numa CRO (Eurotrials, Consultores Científicos) e num centro de investigação clínica (Centro Clínico Académico – Braga, Associação). Este documento começa por analisar o enquadramento europeu da investigação clínica e, posteriormente, a situação portuguesa comparativamente a países similares. De seguida, são descritas as atividades desenvolvidas no âmbito deste estágio, as quais foram divididas em duas fases. A primeira fase desenrolou-se na Eurotrials, Consultores Científicos, uma CRO especializada em investigação clínica e consultoria científica. As primeiras semanas foram dedicadas ao treino e à formação necessários para o desempenho de tarefas como assistente de estudos clínicos. Estas tarefas incluíram a participação em várias atividades de qualificação, iniciação e monitorização de estudos clínicos, assim como o desenvolvimento e aperfeiçoamento de um sistema de gestão de qualidade. A segunda vertente decorreu no 2CA-Braga, um centro de investigação clínica localizado no Hospital de Braga. Nesta fase, o estágio focou-se essencialmente na coordenação de estudos clínicos, assim como, em atividades relacionadas com o processo de revisão/negociação de contratos financeiros. Para além disso, tive a oportunidade de participar nas “1as Jornadas de Investigação Clínica e Inovação” organizadas pelo 2CA-Braga. Globalmente, o estágio traduziu-se numa excelente oportunidade para ganhar conhecimentos e experiência nas tarefas associadas a projetos e serviços no âmbito da implementação e gestão de estudos clínicos, na perspetiva de uma CRO e de um centro de investigação clínica. A integração destas duas perspetivas permitiu-me identificar e confluir necessidades específicas de diferentes players envolvidos na investigação clínica. Concluindo, este estágio permitiu-me aplicar e aperfeiçoar os conhecimentos adquiridos durante a minha formação académica tornando-me capaz de enfrentar e transpor novos desafios na área da investigação clínica.
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Haidamus, Ramzi Albert. « A 68000-based produce sorting microcomputer : graduate clinical research master's report ». Scholarly Commons, 1989. https://scholarlycommons.pacific.edu/uop_etds/2172.
Texte intégralRésumé :
This report discusses in great detail the various research, design, and development stages of the Produce Sorting Microcomputer developed for HAGAN ENGINEERING Inc. The two-semester Clinical Research project has been approved by the graduate committee at the School of Engineering at the University of the Pacific and fulfills the requirements towards a Master Degree in Electrical Engineering.
The project was selected based on its complexity, feasibility, the time span it required to complete, and its relevance to the area of real time microcomputer design. In addition, the design constraints and specifications were to be dictated solely by HAGAN ENGINEERING Inc. and all further modifications were to be discussed and approved by HAGAN. These limitations created a professional industry-like atmosphere, which is one of the goals of the Clinical Research Program.
A brief User's Manual will accompany the MC68000 board; it will contain all the vital information about the system that a programmer or a technician might need to understand the system. The manual wall contain the complete circuit schematic, a parts list, general design features, and all the software properties of the system (memory map, interrupt tables register map).
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Crociati, Naomi. « “L’utilizzo della robotica nella neuroriabilitazione dell’arto superiore : implicazioni cliniche - Case Report" ». Bachelor's thesis, Alma Mater Studiorum - Università di Bologna, 2021. http://amslaurea.unibo.it/24582/.
Texte intégralRésumé :
Background La complessità dei meccanismi neurofisiologici legati al funzionamento dell’arto superiore si riflette nella necessità di tempi di recupero più ampi, ed i risultati, non sempre immediati, porteranno il soggetto ad utilizzare sempre di più l’arto meno affetto andando incontro al fenomeno del learning non-use. La neuroriabilitazione mediata da sistemi robotici è un campo in evoluzione, la cui dimostrazione di efficacia è un aspetto di grande interesse per la ricerca scientifica.
Obiettivo dello studio L’obiettivo di questo studio è verificare quali siano i benefici che derivano dall’utilizzo del dispositivo robotico Armeo® Spring per il recupero dell’arto superiore in persone con esiti di patologia neurologica, attraverso valutazioni cliniche e strumentali.
Materiali e Metodi È stato preso in esame un singolo caso con esiti di emiplegia dell’arto superiore in fase post-acuta. La valutazione è stata effettuata mediante la somministrazione della scala Fugl-Meyer UE e la valutazione specifica proposta dal Software che riguarda i parametri rispetto al ROM articolare, all’area di lavoro e alla coordinazione del movimento.
Risultati Dall’elaborazione dei dati ottenuti dalla valutazione clinica con la Fugl-Meyer UE si evidenzia un miglioramento quantitativo a livello dei movimenti della spalla e del polso. I risultati derivanti dalla valutazione specifica del Software dell’Armeo® Spring, mostrano miglioramenti rispetto al ROM articolare e all’area di lavoro tridimensionale, mentre riportano un andamento costante rispetto all’eumetria.
Conclusioni Il trattamento con Armeo® Spring ha avuto un effetto positivo sulla mobilità e funzionalità dei distretti spalla e polso. Gli aspetti legati alla precisione del movimento, valutati dal Software, non hanno mostrato cambiamenti rilevanti al termine del ciclo di trattamento.
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Ahmed, Omer Abdelrahim Sidig. « Relationship of TMD diagnosis and self-reported biopsychosocial status of patients attending the TMD clinic ». University of the Western Cape, 2018. http://hdl.handle.net/11394/6638.
Texte intégralRésumé :
Magister Scientiae Dentium - MSc(Dent)Background: This study aimed to investigate a possible relationship between the diagnosis of TMD and biographical, psychological and social status of patients. Materials and Method: All records of patients who attended the TMD clinic in the Mitchells Plain Oral Health Centre in the period from January 2015 to July 2018, and who were examined according to the DC/TMD protocol, were collected. All diagnostic observations, as well as their biographical, psychological and social data were recorded. Statistical analysis was performed by means of comparisons and association analysis among data to evaluate if there were any statistically relevant associations or differences.
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Bycroft, Debra. « Probative value of pre-sentence reports for juvenile matters ». Thesis, Edith Cowan University, Research Online, Perth, Western Australia, 2020. https://ro.ecu.edu.au/theses/2291.
Texte intégralRésumé :
The research reported in this thesis was designed to identify the methodology required for the pre-sentence evaluation of a juvenile, the skills and knowledge that inform this methodology, and the report content that should be communicated to the court.
Four sources of data were used: the available literature in the area, a Delphi study of psychologists with expertise in the area who conduct the evaluations and prepare the reports, a survey of judicial officers who receive the reports, and a reference group of psychologists to provide suggestions on how to resolve the minor discrepancies that emerged between the psychologists and the judicial officers. The results show consensus among psychologists on the skills and knowledge required for a pre-sentence report and content of a report. There was agreement on most aspects of methodology except for the need for a formal risk assessment (e.g., using scientific valid assessment tools) and the use of a model to guide the evaluation. In these areas, psychologists are out of step with recommendations in the professional literature. Judicial officers agreed that most content provided in a psychological pre-sentence report was helpful. However, they identified a number of areas where reports could be improved: methodology, transparency, relevance of content, comprehensiveness, and conciseness. Judicial officers provided clarification on a number of other areas: that scientifically based information on risk was always helpful and is mandatory for some offence types; that it was not appropriate for the court to provide feedback on the helpfulness of individual reports; that when addressing physical health or sentencing options in a report, psychologists should take care not to step outside their own competency and psychologists should make transparent the relevance to their data to the legal issue being addressed. The data highlight the need for steps to be taken to improve the standard and consistency of reports.
As the first step to improving standards and consistency, a decision-making model for pre-sentence evaluations is proposed. Having produced this model, researchers now need to test it in the field to determine if applying the model has a positive impact on the helpfulness of reports and if the model can be used in other countries to improve the validity and helpfulness of psychological reports for juvenile sentencing matters.
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Williamson, Jonathan Paul Allan. « Assessing the suitability of cognitive-behavioural therapy for specialised client populations and clinical practice reports ». Thesis, University of Birmingham, 2011. http://etheses.bham.ac.uk//id/eprint/3229/.
Texte intégralRésumé :
Background: For any therapeutic approach, it is important to consider what factors determine its suitability for clients. As cognitive-behavioural therapy (or, CBT), is increasingly being investigated as a therapeutic intervention for adults with intellectual disabilities, this literature review considers the status of empirical evidence concerning factors that determine CBT suitability for this population. Method: Using five electronic databases, searches were conducted to identify relevant empirical papers published between 1997 and 2010. Results: Fifteen studies, of seventeen identified, were reviewed. Studies concerned either factors relating to CBT intervention responsiveness or the ability of participants to complete tasks thought necessary for CBT. Across the reviewed studies, several client and contextual factors of potential importance were identified. The veracity of these findings is considered with reference to study methodological issues. Conclusions: Although a number of potentially important client and contextual factors have been identified in the literature, further investigations are needed to more clearly establish which of these relate to CBT intervention responsiveness.
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Bustos, Aurelia. « Extraction of medical knowledge from clinical reports and chest x-rays using machine learning techniques ». Doctoral thesis, Universidad de Alicante, 2019. http://hdl.handle.net/10045/102193.
Texte intégralRésumé :
This thesis addresses the extraction of medical knowledge from clinical text using deep learning techniques. In particular, the proposed methods focus on cancer clinical trial protocols and chest x-rays reports. The main results are a proof of concept of the capability of machine learning methods to discern which are regarded as inclusion or exclusion criteria in short free-text clinical notes, and a large scale chest x-ray image dataset labeled with radiological findings, diagnoses and anatomic locations. Clinical trials provide the evidence needed to determine the safety and effectiveness of new medical treatments. These trials are the basis employed for clinical practice guidelines and greatly assist clinicians in their daily practice when making decisions regarding treatment. However, the eligibility criteria used in oncology trials are too restrictive. Patients are often excluded on the basis of comorbidity, past or concomitant treatments and the fact they are over a certain age, and those patients that are selected do not, therefore, mimic clinical practice. This signifies that the results obtained in clinical trials cannot be extrapolated to patients if their clinical profiles were excluded from the clinical trial protocols. The efficacy and safety of new treatments for patients with these characteristics are not, therefore, defined. Given the clinical characteristics of particular patients, their type of cancer and the intended treatment, discovering whether or not they are represented in the corpus of available clinical trials requires the manual review of numerous eligibility criteria, which is impracticable for clinicians on a daily basis. In this thesis, a large medical corpora comprising all cancer clinical trials protocols in the last 18 years published by competent authorities was used to extract medical knowledge in order to help automatically learn patient’s eligibility in these trials. For this, a model is built to automatically predict whether short clinical statements were considered inclusion or exclusion criteria. A method based on deep neural networks is trained on a dataset of 6 million short free-texts to classify them between elegible or not elegible. For this, pretrained word embeddings were used as inputs in order to predict whether or not short free-text statements describing clinical information were considered eligible. The semantic reasoning of the word-embedding representations obtained was also analyzed, being able to identify equivalent treatments for a type of tumor in an analogy with the drugs used to treat other tumors. Results show that representation learning using deep neural networks can be successfully leveraged to extract the medical knowledge from clinical trial protocols and potentially assist practitioners when prescribing treatments. The second main task addressed in this thesis is related to knowledge extraction from medical reports associated with radiographs. Conventional radiology remains the most performed technique in radiodiagnosis services, with a percentage close to 75% (Radiología Médica, 2010). In particular, chest x-ray is the most common medical imaging exam with over 35 million taken every year in the US alone (Kamel et al., 2017). They allow for inexpensive screening of several pathologies including masses, pulmonary nodules, effusions, cardiac abnormalities and pneumothorax. For this task, all the chest-x rays that had been interpreted and reported by radiologists at the Hospital Universitario de San Juan (Alicante) from Jan 2009 to Dec 2017 were used to build a novel large-scale dataset in which each high-resolution radiograph is labeled with its corresponding metadata, radiological findings and pathologies. This dataset, named PadChest, includes more than 160,000 images obtained from 67,000 patients, covering six different position views and additional information on image acquisition and patient demography. The free text reports written in Spanish by radiologists were labeled with 174 different radiographic findings, 19 differential diagnoses and 104 anatomic locations organized as a hierarchical taxonomy and mapped onto standard Unified Medical Language System (UMLS) terminology. For this, a subset of the reports (a 27%) were manually annotated by trained physicians, whereas the remaining set was automatically labeled with deep supervised learning methods using attention mechanisms and fed with the text reports. The labels generated were then validated in an independent test set achieving a 0.93 Micro-F1 score. To the best of our knowledge, this is one of the largest public chest x-ray databases suitable for training supervised models concerning radiographs, and also the first to contain radiographic reports in Spanish. The PadChest dataset can be downloaded on request from http://bimcv.cipf.es/bimcv-projects/padchest/. PadChest is intended for training image classifiers based on deep learning techniques to extract medical knowledge from chest x-rays. It is essential that automatic radiology reporting methods could be integrated in a clinically validated manner in radiologists’ workflow in order to help specialists to improve their efficiency and enable safer and actionable reporting. Computer vision methods capable of identifying both the large spectrum of thoracic abnormalities (and also the normality) need to be trained on large-scale comprehensively labeled large-scale x-ray datasets such as PadChest. The development of these computer vision tools, once clinically validated, could serve to fulfill a broad range of unmet needs. Beyond implementing and obtaining results for both clinical trials and chest x-rays, this thesis studies the nature of the health data, the novelty of applying deep learning methods to obtain large-scale labeled medical datasets, and the relevance of its applications in medical research, which have contributed to its extramural diffusion and worldwide reach. This thesis describes this journey so that the reader is navigated across multiple disciplines, from engineering to medicine up to ethical considerations in artificial intelligence applied to medicine.
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Farrica, Anabela de Jesus Prates. « Internship in clinical data management at a clinical research organization ». Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/15136.
Texte intégralRésumé :
Mestrado em Biomedicina FarmacêuticaThe aim of this report is to describe the training activities carried out at the Data Management Sub-Unit of Eurotrials, Scientific Consultants, as part of the 2nd year of the Master’s Program in Pharmaceutical Medicine. This internship was focused on the development of skills and on gaining experience in Clinical Data Management activities. Over the course of this internship, I had the opportunity to build upon the knowledge obtained in the Bachelor’s Degree in Biomedical Sciences and in the Master’s Program in Pharmaceutical Medicine. Concepts, requirements and practices related to Clinical Data Management were explored and strengthened throghout. Furthermore, an unique perspective on the lifecycle of clinical research projects was obtained – that of a CRO. Besides the acquisition of theoretical knowledge, this training period was paramount for the development of a number of social and personal skills that contributed for my profissional growth within the host institution. This document begins by a description of the theoretical principles that set the ground for the Clinical Data Manager’s work. Then, the generic and specific training elements of the curricular training are detailed. After presenting my training activities, I discuss the various challenges I had to overcome during these 9 months. Finally, some personal remarks and conclusions are presented.
Este relatório tem como objetivo descrever as atividades de estágio realizadas na Unidade de Gestão de Dados da Eurotrials, Consultores Científicos, como parte do 2º ano do Mestrado em Biomedicina Farmacêutica. Este estágio focou-se no desenvolvimento de competências e obtenção de experiência em atividades de Gestão de Dados Clínicos. No decurso do estágio tive oportunidade de complementar o conhecimento obtido na Licenciatura em Ciências Biomédicas e no Mestrado em Biomedicina Farmacêutica. Foram aprofundados e explorados os conceitos, requisitos e práticas inerentes à Gestão de Dados Clínicos e obteve-se uma visão única do ciclo de vida de um projeto de investigação clínica – a de uma CRO. Para além da aquisição de conhecimentos teóricos, este período de estágio foi fundamental para o desenvolvimento de um conjunto de aptidões sociais e pessoais que contribuíram para o meu crescimento profissional dentro da instituição de acolhimento. O presente documento começa por expôr os príncipios teóricos que servem de base à atividade do Gestor de Dados Clínicos. Seguidamente, são detalhados os componentes genéricos e específicos de treino adquiridos durante o período de estágio. Depois da apresentação das atividades de estágio, são discutidos os vários desafios enfrentados e é feito um balanço pessoal desta experiência.
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Aroney, Christine Margaret. « Patient Reported Outcomes From Clinical Trials in Medical Retina ». Thesis, The University of Sydney, 2016. http://hdl.handle.net/2123/16054.
Texte intégralRésumé :
Purpose: To determine the patient-centred effectiveness of treatment with the slow release dexamethasone intravitreal implant (DEX implant) and intravitreal bevacizumab using the Impact of Vision Impairment Questionnaire (IVI), a vision-related quality of life (VRQoL) measure, in patients with visual impairment secondary to centre-involving diabetic macular edema (DMO). Methods: Patients with DMO were enrolled in a phase 2, prospective, multicenter, randomized, single-masked clinical trial and received either DEX implant 4 monthly or bevacizumab monthly, both pro re nata. VRQoL was measured at baseline and 24 months, using the IVI’s three component scales, namely Reading, Mobility and Emotional Well-being. Rasch analysis was used to generate interval-level estimates of VRQoL, which were then analysed using t-tests to assess changes over time. Results: 48 patients completed the main study; 43 (90%) answered the IVI at the baseline and 24-month (final efficacy) visits. VRQoL improved significantly, with average increases of 1.44, 0.99 and 1.49 logits, for the Reading, Mobility and Emotional well-being scales respectively, from baseline to 24 months, (p<0.001). There was no significant between-group difference in improvement in VRQoL in the DEX implant only compared with the bevacizumab-only group, in any of the three scales listed above (with 1.41, 1.08 and 2.11 logits improvement, in Reading, Mobility and Emotional well-being respectively for DEX implant group, compared to 1.48, 1.06 and 2.11 for bevacizumab; p-values >0.1.) Conclusions: We found that both DEX implant and bevacizumab treatment result in significant and similar improvements in VRQoL in patients with DMO over a 24-month period.
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Smith, Anabela Da Silva. « Youth Self-Report : profile patterns of adjudicated adolescents and diagnostic efficiency of clinical scales / ». View online ; access limited to URI, 2005. http://0-wwwlib.umi.com.helin.uri.edu/dissertations/dlnow/3206247.
Texte intégral
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Nobre, Ana Rita dos Santos. « Curricular training report about clinical trials monitoring on a CRO full service ». Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/13996.
Texte intégralRésumé :
Mestrado em Biomedicina FarmacêuticaThis report intends to describe the activities carried out under the traineeship which took place in the company Datamédica, Biostatistics Services and Consulting, Inc., a Contract Research Organization (CRO). The internship had the duration of 8 months during which the trainee worked as CRA being the main focus the monitoring of clinical trials. Besides the main activity, have also been developed functions adjacent to the clinical research, such as CTA and Medical Writing areas. This document tries to show the obtained vision and the points of view of the trainee while monitoring clinical trials.
O presente relatório destina-se a descrever as atividades desenvolvidas no âmbito do estágio curricular que teve lugar na empresa Datamédica, Serviços e Consultoria em Bioestatística, Lda., uma Contract Research Organization (CRO). O estágio teve a duração de 8 meses durante os quais a estagiária desempenhou funções de CRA sendo o principal foco a monitorização dos ensaios clínicos. Para além da principal atividade, foram ainda desenvolvidas funções em áreas adjacentes à investigação clínica, tais como CTA e Medical Writing. Este trabalho tenta mostrar a visão obtida e os pontos de vista da estagiária enquanto monitora de ensaios clínicos.
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Luz, Guilherme de Sousa. « Curricular internship report in clinical studies monitoring at a full service CRO ». Master's thesis, Universidade de Aveiro, 2016. http://hdl.handle.net/10773/16979.
Texte intégralRésumé :
Mestrado em Biomedicina FarmacêuticaO presente relatório tem como fim descrever as atividades desenvolvidas e experiência e competências adquiridas durante o estágio curricular numa CRO Full Service, a DATAMEDICA – Consultoria e Serviços em Bioestatística, Lda., no âmbito do Mestrado em Biomedicina Farmacêutica. O principal objectivo do estágio foi adquirir conhecimento e competências inerentes ao desempenho do trabalho de Clinical Research Associate. O estágio curricular teve a duração de 8 meses, compreendidos entre setem-bro de 2015 e abril de 2016, tendo o estágio na DATAMEDICA, no entanto, começado em junho de 2015. Este estágio permitiu a realização de várias fun-ções na área da Investigação Clínica, destacando-se a Submissão e Monitori-zação de Estudos Clínicos, Escrita Médica e Gestão de Dados. Neste estágio foi possível aplicar conteúdos teóricos obtidos durante o Mestrado em Biomedicina Farmacêutica e desenvolver competências necessárias, principalmente, à monitorização de ensaios clínicos, mas também às outras atividades supramencionadas. Para além disso, a integração numa equipa multidisciplinar no meio empresarial e interação, aquando fora da empresa, com outros profissionais da área médica e da investigação clínica resultou num crescimento pessoal e profissional. Na secção do estado da arte são abordados temas como a investigação clíni-ca, evolução do ambiente regulamentar a nível global ao longos dos anos. É também feito um panorama dos ensaios clínicos a nível nacional.
The present report aims at describing the developed activities and experiences and skills acquired during the curricular internship at a Full Service CRO, DATAMEDICA – Consultoria e Serviços em Bioestatística, Lda., in the scope of the Pharmaceutical Medicine Master of Science. The main objective of the in-ternship was to acquire knowledge and skills inherent to performing the Clinical Research Associate job. The curricular internship had a duration of 8 months, from September 2015 until April 2016, having the internship at DATAMEDICA, however, started in June 2015. This internship allowed several roles in the Clinical Investigation area to be performed, highlighting the Clinical Studies’ Submission and Moni-toring, Medical Writing and Data Management activities. In this internship it was possible to put into use theoretical concepts obtained during the Pharmaceutical Medicine Master of Science and to develop skills necessary, mainly, to the clinical study monitoring, but also to the other above-mentioned activities. Beyond this, the integration in a multidisciplinary team in a business environment and interaction, when outside the company, with other medical and clinical investigation professionals has resulted in a personal and professional growth. In the state of the art section, clinical investigation and the evolution of the global regulatory environment are mentioned. A panorama of the clinical trials on a national scale is also made.
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Vicente, Margarida Isabel de Sousa. « Report of a curricular internship at a full service CRO ». Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/14883.
Texte intégralRésumé :
Mestrado em Biomedicina FarmacêuticaThe present report outlines the activities developed and the acquired experience during the curricular internship at DATAMEDICA, Serviços e Consultoria em Bioestatística, Lda., under the scope of the Pharmaceutical Biomedicine Master Course. The internship, which took place between September 2014 and April 2015, allowed the performance of several activities related to Clinical Research, namely preparation of clinical studies submissions to Competent Authorities; monitoring activities; medical writing and data management. The work developed during this internship was essential both to acquire an important basis regarding new professional, personal and social skills and to develop old ones face to Clinical Research and its most relevant stakeholders, such as communication, concentration, sense of responsibility, organisation and correct response in stressful situations. The internship also allowed me to contact with the daily life activities of a Full Service Clinical Research Organisation (CRO) and put into practice the knowledge acquired at the University.
O presente relatório descreve as atividades desenvolvidas e a experiência adquirida durante o estágio curricular realizado na DATAMEDICA, Serviços e Consultoria em Bioestatística, Lda., no âmbito do Mestrado em Biomedicina Farmacêutica. O estágio, que decorreu de Setembro de 2014 a Abril de 2015, permitiu a realização de diversas atividades relacionadas com Investigação Clínica, das quais se destacam: preparação de submissões de estudos clínicos às Autoridades Competentes; monitorização; medical writing e data management. Todo o trabalho desenvolvido durante este estágio foi fundamental para a aquisição de novas competências e desenvolvimento de antigas, tais como comunicação, concentração, sentido de responsabilidade, organização e resposta em situações de stress, que contribuíram para uma melhor preparação a nível profissional, pessoal e social face à Investigação Clínica e seus principais stakeholders. Adicionalmente, o estágio permitiu contactar com as atividades do quotidiano de uma Clinical Research Organisation (CRO) Full Service e colocar em prática os conhecimentos adquiridos durante a formação na Universidade.
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Paul, Lucy Joanne. « An assessment of heart failure screening tools for an outpatient arrhythmia devices clinic ». ScholarWorks, 2017. https://scholarworks.waldenu.edu/dissertations/4320.
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People living with heart failure (PLHF) should be screened for symptoms at every
healthcare visit since they are 3 times more likely to experience ventricular arrhythmias. This quality improvement project (QIP) compared 3 self-administered HF symptoms questionnaires to determine the best screening tool for a tertiary hospital arrhythmia devices clinic. The instruments included the Minnesota Living with Heart Failure Questionnaire (MLHFQ), the Kansas City Cardiomyopathy Questionnaire (KCCQ), and the Self-Reported Heart Failure Symptoms (SHEFS) questionnaire. For a 30-day period, 76 people were eligible to participate in the QIP, with 55 participants included in the final analysis (72.5% participation). The questionnaires were compared and assessed with the gold standard laboratory test for HF (NT-proBNP) for sensitivity and specificity. For HF, the SHEFS was the most sensitive (83%) compared to the NT-proBNP, but the MLHFQ was most specific (89%). When compared to the MLHFQ as the standard, SHEFS was 71% sensitive, and 73% specific for HF. Similarly, when compared to the KCCQ, the SHEFS was both, 75% specific and sensitive in identifying HF. However, the rate of correlation to a positive or negative NT-proBNP test results was the highest for the SHEFS (87%). All 3 questionnaires were statistically significant in predicting admission to hospital for HF in the past 6 months (p = 0.02 to 0.03). Finally, given the shortest length and simplicity of use, the SHEFS was selected by the stakeholders to be the standard screening tool for the clinic. This project contributes to positive social change by providing the first reported comparison in the literature to implement questionnaires in a clinic to assess symptoms for PLHF attending an arrhythmia devices clinic.
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Brocato, Nicole Whyms. « Information gathered by retrospective, self-report, emotional frequency items in children ». Thesis, University of Maryland, Baltimore County, 2014. http://pqdtopen.proquest.com/#viewpdf?dispub=3624332.
Texte intégralRésumé :
Retrospective emotional frequency appraisals are often used in clinical assessment measures, but their suitability for use with children has not been well studied. The aims of this project were to (a) examine whether items that use retrospective frequency structures gather more or less information than items that do not use such structures and (b) examine whether the information gathered by such items differs across children's ages. Method. Data were gathered from 9- to 12-year-old girls who participated in a larger study of a depression treatment protocol. Two sets of five pairs of items were sampled from two children's depression measures. The item pairs contained one item from each measure. One set of item pairs was matched for content and the use of retrospective frequency structures. The other set was matched for content only. Results. For the first research question, information curves for the two item sets were generated using Samejima's (1969) Graded Response Model (GRM). Visual analyses of the information curves provided inconclusive results as to whether the presence of retrospective frequency structures is associated with differences in item information levels. The second research question was conducted in two parts. For both, only data from the 9- and 12-year-old participants were analyzed. In the first part, confirmatory factor analysis was used to analyze measurement invariance across the two groups' responses. Theses analyses showed signs of measurement non-invariance in both item sets. The second part of the analyses was conducted by generating separate GRM information curves for the two age groups and conducting visual analyses of the information curves. These analyses showed that the model which had been used throughout the remainder of the study did not fit the 9-year-old group well. They also showed that the 12-year-old group's information curves varied more in height across measures and item sets than did the 9-year-old group's curves. Discussion. Although the findings failed to shed light on the effects of retrospective frequency structures on children's responding, they highlighted potential differences between the 9- and 12-year-old groups' factor structures and indicated that the 9-year-olds displayed decreased sensitivity to differences in item structure.
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Georgievska, Liljana. « Curricular internship report in medical writing at Blueclinical, Portugal ». Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/15799.
Texte intégralRésumé :
Mestrado em Biomedicina FarmacêuticaThe contents of this report are a summary of the activities carried out during the 8-month internship as an Associate Medical Writer at Blueclinical Ltd, Matosinhos, Portugal. Mainly my activities were related to medical writing, particularly writing the clinical research protocols, clinical study reports, writing manuscript and preparing poster presentations. In addition to these activities, I also participated in performance of a clinical trial from beginning to end. During the period of its realization, I was able to familiarize myself with all the steps of the Phase I clinical trial.
O conteúdo deste relatório é um resumo das actividades realizadas durante o estágio de 8 meses, como escritor Médico Associado na Blueclinical, Ltd, em Matosinhos, Portugal. As atividades desenvolvidas foram essencialmente relacionadas com a escrita médica, nomeadamente a escrita dos protocolos de investigação clínica, dos relatórios de ensaios clínicos, redação e preparação de apresentações de pósteres. Além destas atividades, também tive a oportunidade de acompanhar um ensaio clínico de fase I desde o seu início até ao fim. Durante este estudo, foi possível conhecer de perto todas as etapas de realização de ensaios clínicos de fase I.