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1.
Evid. actual. práct. ambul ; 25(1): e006997, 2022. tab
Article in Spanish | LILACS, BINACIS, UNISALUD | ID: biblio-1367297

ABSTRACT

En Argentina, tres de las vacunas contra el COVID-19 autorizadas por la entidad regulatoria local se aplican en menores de edad: la vacuna desarrollada por Sinopharm (BBIBP-CorV) para niños de 3 años o más, y las desarrolladas por Moderna (ARNm 1273) y Pfizer (BNT162b2) a partir de los 12 años. Dado que estas recomendaciones no coinciden exactamente con las emitidas por diferentes organismos internacionales y debido al corto plazo de seguimiento de los ensayos publicados, surgieron dudas fundamentalmente en relación a su seguridad. En este artículo, los autores sintetizan la evidencia disponible hasta el momento sobre las vacunas aplicadas en niños, niñas y adolescentes en nuestro país, basada en informes preliminares de ensayos clínicos y reportes de vigilancia epidemiológica. (AU)


In Argentina, three of the COVID-19 vaccines authorized by the local regulatory entity are applied to minors: the vaccine developed by Sinopharm (BBIBP-CorV) for children 3 years of age or older, and those developed by Moderna (RNAm1273) and Pfizer (BNT162b2) from the age of 12 and onwards. Given that these recommendations do not coincide exactly with those issued by different international organizations and due to the short follow-up period of the published trials, doubts arose fundamentally in relation to their safety. In this article, the authors summarize the evidence available to date on vaccines applied to children and adolescents in our country, based on preliminary studies of clinical trials and epidemiological surveillance reports. (AU)


Subject(s)
Humans , Male , Female , Child, Preschool , Child , Adolescent , COVID-19 Vaccines/pharmacology , COVID-19/immunology , COVID-19/prevention & control , Argentina , Clinical Trials as Topic , Epidemiological Monitoring , SARS-CoV-2
2.
Rev. cuba. inform. méd ; 13(1): e414, ene.-jun. 2021. graf
Article in Spanish | LILACS, CUMED | ID: biblio-1251727

ABSTRACT

El ensayo clínico constituye el método empleado para evaluar un producto, sustancia, medicamento, técnica diagnóstica o terapéutica. La industria biotecnológica emplea sistemas de gestión de ensayos clínicos para lograr un manejo eficiente de los datos recopilados durante el proceso. El Centro de Inmunología Molecular (CIM) emplea el Sistema de Gestión de Ensayos Clínicos XAVIA Clínicas desarrollado por la UCI, para soportar el 100 por ciento de los ensayos clínicos desde el 2012. XAVIA Clínicas posee limitantes en sus funcionalidades; además, a partir de la experiencia obtenida por su uso, se identificaron mejoras y nuevas funcionalidades que constituyen el incentivo para desarrollar un nuevo sistema. El objetivo del presente artículo es presentar el Sistema para el manejo de datos de Ensayos Clínicos XAVIA SIDEC y su generalización en las instituciones de BioCubaFarma. Se estudió la bibliografía referente al manejo de datos de ensayos clínicos y cuadernos de recogida de datos electrónicos y se analizaron sistemas homólogos disponibles en el mercado internacional. La metodología de desarrollo empleada fue AUP-UCI. Se utilizó Eclipse como entorno integrado de desarrollo, Java como lenguaje de programación, JBoss como servidor de aplicaciones y PostgreSQL como sistema de gestión de bases de datos. El Sistema para el manejo de datos de Ensayos Clínicos XAVIA SIDEC facilita y flexibiliza el diseño y aprobación de los Cuadernos de recogida de información (CRD), estandariza la información manejada, valida los datos recopilados a través de reglas, mejora el flujo de información entre las entidades que conducen el ensayo y optimiza el proceso de monitoreo(AU)


Clinical trial is the method used to evaluate a product, substance, medicine, diagnostic or therapeutic technique. The biotechnology industry employs clinical trial management systems to achieve efficient management of data collected during clinical trials. CIM (Centro de Inmunología Molecular) uses the Clinical Trials Management System XAVIA Clínicas developed by UCI, to support 100 percent of clinical trials since 2012. This system has limitations in its functionalities; furthermore, based on the experience obtained, improvements and new functionalities were identified, so it was decided to develop a new version of the system. The objective of this article is to present the Clinical Trials Data Management System XAVIA SIDEC and its generalization in BioCubaFarma institutions. The bibliography referring to the clinical trial data management and electronic data collection notebooks was studied and homologous systems available in the international market were analyzed. The development methodology used was AUP-UCI. Eclipse was used as an integrated development environment, Java as a programming language, JBoss as an application server and PostgreSQL as a database management system. The Clinical Trials Data Management System XAVIA SIDEC facilitates and makes the Case Report Forms (CRF) design and approval more flexible, standardizes the information handled, validates the data collected through rules, improves the flow of information between the entities conducting the trial and optimizes the monitoring process(AU)


Subject(s)
Software Design , Clinical Trials as Topic/methods , Clinical Trial Protocols as Topic
3.
Rev. panam. salud pública ; 45: e33, 2021. tab, graf
Article in Spanish | LILACS | ID: biblio-1252032

ABSTRACT

RESUMEN Se está llevando a cabo un número considerable de ensayos clínicos en todo el mundo en respuesta a la pandemia de COVID-19, incluso en países de ingresos bajos y medios como los de América Latina y el Caribe. Sin embargo, la abundancia de estudios no necesariamente acorta el camino para encontrar intervenciones seguras y eficaces frente a la COVID-19. Se analizaron los ensayos para el tratamiento y la prevención de la COVID-19 de los países de América Latina y el Caribe que están registrados en la Plataforma de Registros Internacionales de Ensayos Clínicos de la Organización Mundial de la Salud, y se identificó una tendencia hacia la realización de estudios pequeños, repetitivos y no rigurosos que duplican los esfuerzos y merman recursos limitados sin producir conclusiones significativas sobre la seguridad y la eficacia de las intervenciones evaluadas. Se evaluaron asimismo los desafíos que plantea la realización de investigaciones científicamente sólidas y socialmente valiosas en América Latina y el Caribe a fin de brindar recomendaciones que alienten la realización de ensayos clínicos que tengan más probabilidades de producir evidencia sólida durante la pandemia.


ABSTRACT A considerable number of clinical trials is being conducted globally in response to the COVID-19 pandemic, including in low- and middle-income countries such as those in the Latin America and Caribbean region (LAC). Yet, an abundance of studies does not necessarily shorten the path to find safe and efficacious interventions for COVID-19. We analyze the trials for COVID-19 treatment and prevention that are registered from LAC countries in the International Clinical Trials Registry Platform, and identify a trend towards small repetitive non-rigorous studies that duplicate efforts and drain limited resources without producing meaningful conclusions on the safety and efficacy of the interventions being tested. We further assess the challenges to conducting scientifically sound and socially valuable research in the LAC region in order to inform recommendations to encourage clinical trials that are most likely to produce robust evidence during the pandemic.


Subject(s)
Humans , Clinical Trials as Topic/statistics & numerical data , Developing Countries , COVID-19/prevention & control , COVID-19/therapy , Caribbean Region , Latin America
4.
Brasília; Brasil. Ministério da Saúde; 2021.
Monography in Portuguese | LILACS, BRISA | ID: biblio-1254554

ABSTRACT

DEFINIÇÃO DE REVISÃO SISTEMÁTICA: A RS sintetiza os resultados de estudos primários que se enquadram nos critérios de elegibilidade para responder uma pergunta de pesquisa3. A busca por estudos é realizada de forma sistemática, por meio de várias fontes de dados, com o uso de uma estratégia de busca ampla e sensível7 . A pergunta da pesquisa nas RS de ECR é estruturada no formato PICO (População, Intervenção, Comparador e Desfecho ­ em inglês, outcome). Esse tipo de revisão se baseia em métodos rigorosos, explícitos e reprodutíveis, para minimizar o risco de viés, entender as inconsistências dos resultados e então fornecer resultados confiáveis para a tomada de decisão. DEFINIÇÃO DE META-ANÁLISE META-ANÁLISE: é um método estatístico que pode ser realizado em RS para combinar os resultados de dois ou mais estudos independentes, que podem testar ou não a mesma pergunta/hipótese, gerando uma única estimativa de efeito8. A meta-análise pode ser em pares/ direta ou as meta-análises em rede, ou meta-análises de comparações múltiplas. Na presente diretriz, serão apresentados apenas os conceitos de meta-análise em pares. A vantagem da meta-análise é que esta pode apresentar uma estimativa mais precisa do tamanho do efeito, com considerável aumento do poder estatístico, o que é importante quando o poder do estudo primário é limitado devido ao pequeno tamanho da amostra9. Uma meta-análise pode, em alguns casos, produzir resultados conclusivos quando estudos individuais primários são inconclusivos. Uma RS não necessariamente precisa apresentar uma meta-análise para sintetizar seus resultados. Ao contrário, em alguns casos não é apropriado que elas sejam realizadas, podendo até mesmo gerar conclusões errôneas. Nesse caso, sínteses qualitativas devem ser utilizadas. IMPORTÂNCIA DAS REVISÕES SISTEMÁTICAS: A RS sintetiza os estudos primários da literatura sobre uma questão específica de pesquisa, auxiliando a tomada de decisão na saúde em torno da melhor conduta terapêutica ou profilática. Além disso, esse tipo de estudo ajuda a evitar desperdícios de pesquisa, garantindo que novas pesquisas primárias sejam realizadas com pleno conhecimento da evidência existente11. Um único estudo primário frequentemente não consegue detectar diferenças clinicamente relevantes de efeitos entre dois tratamentos, pois elaborar um ECR, com estimativas corretas para o cálculo do tamanho de amostra e poder estatístico adequados, exige, na maioria das vezes, um tamanho de amostra bastante significativo. Finalizar um ECR com um tamanho de amostra grande necessita de infraestrutura, recursos humanos especializados e recursos financeiros importantes, não disponíveis na maioria das vezes. De qualquer forma, RS com ou sem meta-análise são complementares aos estudos randomizados, por fornecerem ao profissional de saúde uma síntese do conhecimento atual disponível11. As RS também podem contribuir para aumentar a validade externa dos estudos, ou seja, contribuir para a generalização dos resultados. Em algumas situações, os achados de um estudo particular podem ser válidos apenas para uma população com as mesmas características das investigadas no estudo 10. LIMITAÇÕES E DESAFIOS DA ELABORAÇÃO DE REVISÕES SISTEMÁTICAS: As RS possuem alguns desafios, como a gestão de grande volume de informações e extração de dados, o tempo para a realização do estudo e as possíveis limitações de recursos humanos e materiais disponíveis12. As principais limitações que podem afetar a confiabilidade dos resultados de uma RS são o viés de publicação, além de dificuldades em combinar estudos que possam ter diferenças nas populações, nas intervenções, nos comparadores e na definição dos desfechos (diversidade clínica). Assim, é necessário explorar criticamente a evidência apresentada pela RS. Interpretações enganosas podem ser evitadas se princípios básicos forem observados. Nessa diretriz, serão discutidas as etapas para realização de RS de ECR, com ênfase em princípios básicos para garantir a validade dos resultados. RECURSOS NECESSÁRIOS: O conjunto de recursos, conhecimentos e habilidades da equipe envolvida é decisivo para a realização de uma RS de forma otimizada. O tempo é fator predominante e vai depender do tema e do escopo da revisão, assim como das habilidades e dos conhecimentos técnicos dos revisores. É preciso estimar o tempo que será necessário para a condução da RS e a disponibilidade que cada membro da equipe terá para trabalhar na revisão. A elaboração de um cronograma é importante, e este deve incluir todas as etapas, como treinamentos, reuniões, desenvolvimento do protocolo, busca e seleção dos estudos, extração e análise de dados etc. É importante prever gastos, como a necessidade de contratar um tradutor, para tradução de estudos em idioma não dominado pela equipe, ou comprar estudos em texto completo, não disponíveis para os revisores. Assim, sugere-se a elaboração de um orçamento, contemplando todos os itens com seus respectivos valores. Os recursos financeiros podem ser próprios ou podem ser financiados por entidades de agências de fomento à pesquisa (ex.: Conselho Nacional de Desenvolvimento Científico e Tecnológico [CNPq], Fundação de Amparo à Pesquisa do Estado de São Paulo [Fapesp] etc.), instituições responsáveis pela avaliação tecnológica (Ministério da Saúde) ou envolvidas na elaboração de diretrizes para prática clínica (sociedades brasileiras de especialidades clínicas). Recursos humanos: é importante estimar o número de pessoas que irão compor a equipe da revisão, em quais etapas, quem será o coordenador principal da revisão, a necessidade de consultoria de especialistas no assunto, além de apoio estatístico e bibliotecário (se necessário). É importante ter pelo menos três pesquisadores envolvidos para que seja possível minimizar os vieses e os erros em todos os estágios da RS7 . A equipe de pesquisa pode conter outros membros da sociedade envolvidos com o tema, os quais podem ser consultados em vários estágios da RS, como profissionais de saúde especialistas no tema pesquisado, representantes de pacientes, usuários de serviços e especialistas em métodos estatísticos7 . As habilidades e os conhecimentos são fundamentais para a garantia da qualidade metodológica da RS. Assim, conhecimentos aprofundados sobre métodos de pesquisa, epidemiologia, conhecimento clínico da questão de pesquisa, informática e domínio de língua inglesa são necessários. Além disso, a equipe deve saber utilizar as ferramentas necessárias à condução da revisão, como os gerenciadores de referência, bases de dados bibliográficas, softwares que auxiliem na condução ou no relato da revisão sistemática, programas estatísticos para meta-análise. Recursos materiais: é importante estimar todos os recursos necessários para elaboração da RS, como computadores, acesso à internet, softwares de gerenciamento de referências (por exemplo, Mendeley, Endnote, Zotero), e softwares estatísticos (RevMan, R, Stata, Comprehensive Meta-Analysis, por exemplo), além de eventual aquisição de textos completos de publicações com acesso restrito.


Subject(s)
Meta-Analysis as Topic , Clinical Trials as Topic/standards , Cost-Benefit Analysis , Health Sciences, Technology, and Innovation Management , Government Agencies/standards , Brazil
5.
Rev. panam. salud pública ; 45: e33, 2021. tab, graf
Article in Spanish | LILACS | ID: biblio-1289875

ABSTRACT

RESUMEN Se está llevando a cabo un número considerable de ensayos clínicos en todo el mundo en respuesta a la pandemia de COVID-19, incluso en países de ingresos bajos y medios como los de América Latina y el Caribe. Sin embargo, la abundancia de estudios no necesariamente acorta el camino para encontrar intervenciones seguras y eficaces frente a la COVID-19. Se analizaron los ensayos para el tratamiento y la prevención de la COVID-19 de los países de América Latina y el Caribe que están registrados en la Plataforma de Registros Internacionales de Ensayos Clínicos de la Organización Mundial de la Salud, y se identificó una tendencia hacia la realización de estudios pequeños, repetitivos y no rigurosos que duplican los esfuerzos y merman recursos limitados sin producir conclusiones significativas sobre la seguridad y la eficacia de las intervenciones evaluadas. Se evaluaron asimismo los desafíos que plantea la realización de investigaciones científicamente sólidas y socialmente valiosas en América Latina y el Caribe a fin de brindar recomendaciones que alienten la realización de ensayos clínicos que tengan más probabilidades de producir evidencia sólida durante la pandemia.


ABSTRACT A considerable number of clinical trials is being conducted globally in response to the COVID-19 pandemic, including in low- and middle-income countries such as those in the Latin America and Caribbean region (LAC). Yet, an abundance of studies does not necessarily shorten the path to find safe and efficacious interventions for COVID-19. We analyze the trials for COVID-19 treatment and prevention that are registered from LAC countries in the International Clinical Trials Registry Platform, and identify a trend towards small repetitive non-rigorous studies that duplicate efforts and drain limited resources without producing meaningful conclusions on the safety and efficacy of the interventions being tested. We further assess the challenges to conducting scientifically sound and socially valuable research in the LAC region in order to inform recommendations to encourage clinical trials that are most likely to produce robust evidence during the pandemic.


Subject(s)
Humans , Clinical Trials as Topic/statistics & numerical data , COVID-19/prevention & control , COVID-19/therapy , Caribbean Region , Latin America
6.
Article in Chinese | WPRIM | ID: wpr-888161

ABSTRACT

Clinical trail report is a summary of the process and results of clinical trail, an important basis to support the effectiveness and safety evaluation of drug marketing and an important technical data required for drug registration. Safety analysis is the main part and the most common issue of clinical trial report. In this article, it is summarized and analyzed the common problems found in the safety analysis part of the clinical trial report of new drugs of traditional Chinese medicine(TCM) in combination with the clinical professional evaluation of the application for marketing license of innovative TCM. The common problems in writing the safety aspects of clinical trail reports were summarized and analyzed, including the omissions of adverse events and laboratory test results, the failure to provide a detailed list of laboratory test outliers, the lack of professional depth in the analysis of the causal relationship between adverse events and TCM. In view of the common problems, it is suggested that the drug use degree, adverse events and adverse reactions, as well as laboratory examination should be considered. Check the three dimensions for necessary medical analysis, collation and summary and continuously improve the quality of safety analysis in clinical trial reports.


Subject(s)
Clinical Trials as Topic , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese Traditional
7.
Chinese Journal of Lung Cancer ; (12): 790-795, 2021.
Article in Chinese | WPRIM | ID: wpr-922148

ABSTRACT

Small cell lung cancer (SCLC) is a neuroendocrine tumor with fast progression, high malignancy, easy recurrence, and extremely poor prognosis. In the past 30 years, the clinical treatment strategy of SCLC has been mainly chemotherapy and radiotherapy, but the curative effect is not significant; the current immunotherapy of SCLC has gradually entered the clinic and has made certain progress. Tumor immunotherapy includes immune checkpoint inhibitors, tumor vaccines, cytokines, chimeric antigen receptor T-cell immunotherapy (CAR-T) therapy, etc. Currently, immune checkpoint inhibitors are the most widely used. This article summarizes the principles of immune checkpoint inhibitors and related drugs, summarizes their domestic and foreign clinical trials progress in SCLC treatment, reviews the biomarkers used in the therapy, and discusses its future development direction.
.


Subject(s)
Cancer Vaccines/therapeutic use , Clinical Trials as Topic , Humans , Immune Checkpoint Inhibitors , Immunotherapy , Lung Neoplasms/drug therapy , Small Cell Lung Carcinoma/drug therapy
8.
Chinese Acupuncture & Moxibustion ; (12): 1276-1280, 2021.
Article in Chinese | WPRIM | ID: wpr-921045

ABSTRACT

Taking the clinical trial of acupuncture in treatment of postprandial distress syndrome as an example, this paper proposes that the acupuncture clinical trial protocol should be optimized in view of acupuncture prescription, acupuncture frequency and outcomes. Besides, the data quality of acupuncture clinical trial should be improved in consideration of data sharing and electronic data capture so as to provide a reference for the majority of researchers to optimize and implement acupuncture clinical trial.


Subject(s)
Acupuncture Therapy , Clinical Trials as Topic , Dyspepsia/therapy , Humans , Research Personnel , Stomach Diseases/therapy , Treatment Outcome
9.
Chinese Acupuncture & Moxibustion ; (12): 1267-1270, 2021.
Article in Chinese | WPRIM | ID: wpr-921043

ABSTRACT

The differences in the objective, starting point, disease spectrum and interventions of acupuncture-moxibustion clinical trials at home and abroad are collected. By taking two articles of acupuncture-moxibustion clinical trials in foreign countries accepted by


Subject(s)
Acupuncture , Acupuncture Therapy , Clinical Trials as Topic , Internationality , Medicine, Chinese Traditional , Moxibustion
10.
Chinese Acupuncture & Moxibustion ; (12): 1147-1152, 2021.
Article in Chinese | WPRIM | ID: wpr-921024

ABSTRACT

The appropriate sample size estimation is very important in the design of clinical trials. However, insufficient or inappropriate sample size estimation is still a prominent problem in the currently published acupuncture and moxibustion clinical trials. At present, the superiority test, non-inferiority test and equivalence test have been widely used in acupuncture and moxibustion clinical trials. This article focuses on the application, calculation methods and PASS11 software using of these three hypothesis test types. In view of the problems in the estimation of sample size in acupuncture and moxibustion clinical trials, the particularity of sample size estimation in acupuncture and moxibustion is summarized from the aspects of parameter setting, ratio of intervention group and control group, and multi-group comparison, in order to guide acupuncture clinical researchers to correctly estimate sample size when conducting clinical trials.


Subject(s)
Acupuncture , Acupuncture Therapy , Clinical Trials as Topic , Moxibustion , Sample Size
11.
Article in Chinese | WPRIM | ID: wpr-879082

ABSTRACT

Since "the implementation of good clinical practice"(GCP), especially after 2015, the overall quality of new drug cli-nical trials in China has made significant progress, but compared with developed countries, there are still some obvious quality problems in clinical trials in China. Clinical trials of new drugs of traditional Chinese medicine are an important part of clinical trials of new drugs in China. In addition to some common problems in all clinical trials, there are also some special quality problems. In terms of security data, such as the collection of human safety data is not standardized, the management and judgment of unexpected serious adverse reactions(SUSAR) were not professional and timely, the relationship between adverse events and trial drug was not fully judged by investigator, In terms of effective data, such as primary efficacy outcome of the scale cannot be traced, TCM syndrome data cannot meet the requirements of "source data" in the revised GCP and the quality of traditional Chinese medicine placebo is not high, in terms of overall quality system construction, the sponsors and research institutions have not established a quality assurance system that conforms to the characteristics of new drug research of traditional Chinese medicine, etc. The quality of clinical trials of new drugs of traditional Chinese medicine is based on the current GCP and ICH-GCP in China, we should also consider the characteristics of clinical trials of new traditional Chinese medicine drugs, and formulate targeted quality control measures according to the characteristics of these new drugs of traditional Chinese medicine, to improve the overall quality of clinical trials of new drugs of traditional Chinese medicine in China, which has important strategic significance for promoting the research and development of new drugs of traditional Chinese medicine in China.


Subject(s)
China , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Quality Control
12.
Article in Chinese | WPRIM | ID: wpr-879081

ABSTRACT

At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.


Subject(s)
Biomedical Research , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal , Ethical Review , Humans , Medicine, Chinese Traditional , Multicenter Studies as Topic , Pharmaceutical Preparations
13.
Chinese Medical Journal ; (24): 765-776, 2021.
Article in English | WPRIM | ID: wpr-878108

ABSTRACT

BACKGROUND@#Reviving patients with prolonged disorders of consciousness (DOCs) has always been focused and challenging in medical research. Owing to the limited effectiveness of available medicine, recent research has increasingly turned towards neuromodulatory therapies, involving the stimulation of neural circuits. We summarised the progression of research regarding neuromodulatory therapies in the field of DOCs, compared the differences among different studies, in an attempt to explore optimal stimulation patterns and parameters, and analyzed the major limitations of the relevant studies to facilitate future research.@*METHODS@#We performed a search in the PubMed database, using the concepts of DOCs and neuromodulation. Inclusion criteria were: articles in English, published after 2002, and reporting clinical trials of neuromodulatory therapies in human patients with DOCs.@*RESULTS@#Overall, 187 published articles met the search criteria, and 60 articles met the inclusion criteria. There are differences among these studies regarding the clinical efficacies of neurostimulation techniques for patients with DOCs, and large-sample studies are still lacking.@*CONCLUSIONS@#Neuromodulatory techniques were used as trial therapies for DOCs wherein their curative effects were controversial. The difficulties in detecting residual consciousness, the confounding effect between the natural course of the disease and therapeutic effect, and the heterogeneity across patients are the major limitations. Large-sample, well-designed studies, and innovations for both treatment and assessment are anticipated in future research.


Subject(s)
Clinical Trials as Topic , Consciousness , Consciousness Disorders/therapy , Humans , Treatment Outcome
14.
Rev. cuba. inform. méd ; 12(2): e381, tab, graf
Article in Spanish | LILACS, CUMED | ID: biblio-1144468

ABSTRACT

Introducción: El Centro Nacional Coordinador de Ensayos Clínicos (CENCEC) utiliza el software OpenClinica para diseñar los Cuadernos de Recogida de Datos (CRD) de los ensayos clínicos. Cada ensayo tiene características específicas, pero existen datos comunes a todos los ensayos que pueden ser estandarizados. Objetivo: Desarrollar una biblioteca de plantillas para el diseño de los CRD. Método: Se realizó un análisis documental de los estándares para el manejo de datos en los ensayos clínicos y se analizaron los diseños utilizados en cuatro ensayos desarrollados en OpenClinica. Resultados: Según los tipos de datos que se registran en los ensayos clínicos se diseñaron 14 plantillas. Cada plantilla, es un fichero Excel con cinco hojas de trabajo donde se registran todas las definiciones del CRD. Las plantillas se han utilizado en tres ensayos clínicos con resultados favorables. Conclusión: Las 14 plantillas que componen la biblioteca CRD fueron diseñadas permitiendo su futura reutilización en la gestión de datos de nuevos ensayos clínicos(AU)


Introduction: CENCEC uses OpenClinica software to design the database of the Case Report Forms (CRF) of the clinical trials (CT). Every trial has specific characteristics although some of them are common to all trials which permit to standardize the process. Objective: To develop a library of templates in order to design the CRF. Methods: A documentary analyses of the standards for data management in clinical trials was performed and in addition of that four designs developed at OpenClinica were reviewed. Results: A library of 14 templates according to data types of CT was proposed. Every template is an Excel file with five sheets in which the definitions of the CRF is registered. The templates have been used in three CT. Conclusions: The 14 templates that make up the CRF library were designed allowing their future reuse in the management of data from new clinical trials(AU)


Subject(s)
Software Design , Software , Clinical Trials as Topic , Data Management
15.
Washington; PAHO; Dec. 18, 2020. 163 p.
Non-conventional in English | PIE, LILACS, PIE | ID: biblio-1145577

ABSTRACT

This is the thirteenth edition of this summary of rapid systematic reviews, which includes the results of currently available literature. More than 200 therapeutic options or their combinations are being investigated in more than 1,700 clinical trials. In this review, 58 therapeutic options are examined. The Pan American Health Organization (PAHO) is continually monitoring ongoing research on any possible therapeutic options. As evidence emerges, then PAHO will immediately assess and update its position, and particularly as it applies to any special sub-group populations such as children, pregnant women, those with immune conditions, etc.


Subject(s)
Humans , Pneumonia, Viral/drug therapy , Coronavirus Infections/drug therapy , Pandemics/prevention & control , Betacoronavirus/drug effects , Antiviral Agents/therapeutic use , Clinical Trials as Topic , Immunologic Factors/immunology
16.
Int. j. odontostomatol. (Print) ; 14(4): 670-677, dic. 2020.
Article in Spanish | LILACS | ID: biblio-1134556

ABSTRACT

RESUMEN: El tratamiento de dientes inmaduros necróticos es hoy un gran desafío clínico. La ausencia de cierre del ápice y el reducido grosor de las paredes de la dentina hacen que el tratamiento endodóntico del diente sea difícil e impredecible. Tradicionalmente, estos dientes han sido tratados con apexificación y obturación del canal radicular, sin embargo, con este tratamiento el diente permanece desvitalizado y con paredes de dentina frágiles y cortas, lo que compromete su pronóstico. La endodoncia regenerativa, por el contrario, busca revitalizar el diente e inducir una maduración de la raíz, y se basa en la utilización de las células madre mesenquimales presentes en la región periapical, los factores de crecimiento presentes en la dentina y un andamio que permite el crecimiento de tejido nuevo al interior del canal. Los resultados clínicos son alentadores, ya que en general existe maduración de la raíz y revascularización del diente, sin embargo, el tejido neoformado es tejido de tipo reparativo y, a excepción de estudios ocasionales, no se ha observado regeneración de dentina y pulpa. La endodoncia regenerativa se originó para tratar dientes inmaduros necróticos. Sin embargo, recientemente, estudios preliminares han expandido la aplicación de la endodoncia regenerativa a dientes maduros necróticos, es decir, en pacientes adultos. Los resultados clínicos son positivos y similares a los del diente inmaduro, si n embargo, la investigación referente a la revitalización de dientes maduros se encuentra en etapas tempranas y requiere de un mayor nivel de evidencia antes de ser ofrecida sistemáticamente como terapia a pacientes adultos. Los beneficios potenciales justifican mayor investigación al respecto. Este artículo resume la evidencia científica disponible con respecto a la revitalización de dientes inmaduros y maduros necróticos, sus fundamentos biológicos, los resultados esperados y limitaciones, así como el protocolo clínico.


ABSTRACT: Nowadays, the treatment of immature necrotic teeth is an important clinical challenge. The absence of apex closure and low thickness of the dentin walls, make endodontic treatment unpredictable and difficult. Traditionally, these teeth have been treated with apexification and obturation of the root canal. As a result of this treatment, the tooth remains devitalized and with fragile and short dentin walls, which compromises its prognosis. Regenerative endodontics, on the other hand, seeks to revitalize the tooth and induce root maturation, and is based on the use of mesenchymal stem cells present in the periapical tissues, growth factors present in the dentin and a scaffold that allows growth of new tissue in the root ca- nal. The clinical results are encouraging, since generally, there is root maturation and revascularization of the tooth. However, the newly formed tissue is reparative tissue and with the exception of some studies, no regeneration of dentin and pulp has been reported. Regenerative endodontics emerged to treat necrotic immature teeth. However, recently, preliminary studies have applied regenerative endodontics in mature necrotic teeth, in adult patients. Preliminary results are positive and are similar to those of immature teeth. Nevertheless, research regarding the revitalization of mature teeth is in the early stages and requires further evidence before being systematically administered as therapy in adult patients. However, the potential benefits justify further research in this regard. This article summarizes the available scientific evidence regarding the revitalization of immature and mature necrotic teeth, their biological basis, the expected results and limitations, as well as the clinical protocols for each case.


Subject(s)
Humans , Adult , Dental Pulp Necrosis/therapy , Dentition, Permanent , Regenerative Endodontics/methods , Clinical Protocols/standards , Clinical Trials as Topic , Treatment Outcome , Neovascularization, Physiologic , Dental Pulp Necrosis/drug therapy , Mesenchymal Stem Cell Transplantation , Tissue Scaffolds
17.
Washington; PAHO; Nov. 13, 2020. 128 p.
Non-conventional in English | PIE, LILACS, PIE | ID: biblio-1140054

ABSTRACT

This is the twelfth edition of this summary of rapid systematic reviews, which includes the results of currently available literature. More than 200 therapeutic options or their combinations are being investigated in more than 1,700 clinical trials. In this review, 58 therapeutic options are examined. The Pan American Health Organization (PAHO) is continually monitoring ongoing research on any possible therapeutic options. As evidence emerges, then PAHO will immediately assess and update its position, and particularly as it applies to any special sub-group populations such as children, expectant mothers, those with immune conditions, etc.


Subject(s)
Humans , Pneumonia, Viral/drug therapy , Coronavirus Infections/drug therapy , Pandemics/prevention & control , Betacoronavirus/drug effects , Antiviral Agents/therapeutic use , Clinical Trials as Topic , Immunologic Factors/immunology
18.
Washington; PAHO; Nov. 30, 2020. 131 p.
Non-conventional in English | PIE, LILACS, PIE | ID: biblio-1140053

ABSTRACT

This is the twelfth edition of this summary of rapid systematic reviews, which includes the results of currently available literature. More than 200 therapeutic options or their combinations are being investigated in more than 1,700 clinical trials. In this review, 58 therapeutic options are examined. The Pan American Health Organization (PAHO) is continually monitoring ongoing research on any possible therapeutic options. As evidence emerges, then PAHO will immediately assess and update its position, and particularly as it applies to any special sub-group populations such as children, expectant mothers, those with immune conditions, etc.


Subject(s)
Humans , Pneumonia, Viral/drug therapy , Coronavirus Infections/drug therapy , Pandemics/prevention & control , Betacoronavirus/drug effects , Antiviral Agents/therapeutic use , Clinical Trials as Topic , Immunologic Factors/immunology
19.
Rev. medica electron ; 42(5): 2288-2300, sept.-oct. 2020. graf
Article in Spanish | LILACS, CUMED | ID: biblio-1144734

ABSTRACT

RESUMEN Introducción: los profesionales dedicados a la medicina natural y tradicional deben establecer y divulgar las evidencias científicas para su uso adecuado y seguro. Objetivos: identificar artículos científicos relacionados con investigaciones clínicas sobre medicina natural y tradicional en revistas médicas cubanas y describir algunas de sus características. Material y Método: estudio descriptivo, transversal; se analizaron los artículos originales publicados entre los años 2007 y 2018 en seis revistas médicas cubanas: Plantas Medicinales, Medicina Natural y Tradicional, Medicina General Integral, Estomatología, Medicina Militar y Farmacia; realizados en personas y en Cuba. Se identificó año de publicación, tipo de estudio (descriptivo, analítico, ensayo clínico), variable principal (eficacia, seguridad, otros), provincia dónde se ejecutó; en los ensayos clínicos se identificó la modalidad empleada, la enfermedad del paciente y el nivel de atención de salud en que se realizaron. Resultados: se encontraron 36 artículos; se publicaron más en los años 2007 y 2016; 69,4 % eran ensayos clínicos; la mayoría se realizó en La Habana (41,6%). En los ensayos clínicos las modalidades más estudiadas fueron la acupuntura (28,0 %) y la fitoterapia, 20,0%; se emplearon más en pacientes con enfermedades estomatológicas, 28,0%; su ejecución predominó en el nivel primario de atención de salud, 64,0%. Conclusiones: fueron insuficientes los artículos relacionados con investigaciones clínicas sobre medicina natural y tradicional que se publicaron en seis revistas que abordan esta temática, esta situación atenta contra la prescripción de esta opción terapéutica, basada en evidencias científicas (AU).


SUMMARY Introduction: the professionals devoted to natural and traditional medicine should study and publish the scientific evidences for its rational and safe use. Objectives: to identify scientific articles related to clinical researches on natural and traditional medicine in Cuban medical journals and to describe some of their characteristics. Materials and methods: a cross-sectional descriptive study; the authors analyzed the original articles published in the period 2007-2018 on researches made in Cuban people and in Cuba in six Cuban medical journals: Plantas Medicinales, Medicina Natural y Tradicional, Medicina General Integral, Estomatología, Medicina Militar y Farmacia. The year of publication, kind of study (descriptive, analytic, clinical trial), main variable (efficacy, safeness, others), and province where they were identified; in the case of clinical trial: the used modality, the patient's disease and the level of the health care where they took place were also identified. Results: 36 articles were found; the years when they were published the most were 2007 and 2016; 69.4 % were clinical trials; most of them were carried out in La Habana (41.6 %). In clinical trials, the most studied modalities were acupuncture (28.0 %) and physiotherapy (20.0 %); they were used more in patients with dental diseases (28.0 %); they were used mainly at the primary health care (64.0 %). Conclusions: there were insufficient the articles related to clinical researches on natural and traditional medicine published in six journals approaching these themes; this situation attempts against the use of this therapeutic use, based on scientific evidences (AU).


Subject(s)
Humans , Male , Female , Research/classification , Medicine, Traditional/history , Periodicals as Topic , Societies , Clinical Trials as Topic/methods , Journal Article
20.
Säo Paulo med. j ; 138(5): 441-456, Sept.-Oct. 2020. tab, graf
Article in English | SES-SP, LILACS, SES-SP | ID: biblio-1139723

ABSTRACT

ABSTRACT BACKGROUND: The dangerous SARS-CoV-2 virus first emerged in China in December 2019 and has rapidly spread worldwide. Currently, it has affected more than 2,850,000 people. No vaccine or drug is available yet, and therefore researchers and scientists are striving to identify potential drugs or vaccines for combating this virus. We were unable to find any review of the literature or analysis on ongoing registered clinical trials that reported diagnostic tests, therapeutics, vaccines and devices for COVID-19 along with estimated enrollment, participants' ages, study type, start and completion date, status, treatment/intervention and country. OBJECTIVE: To review ongoing trials relating to COVID-19. METHODS: A systematic search for clinical trials was conducted in the ClinicalTrials.gov database up to April 12, 2020. A total of 339 trials relating to COVID-19 were analyzed and key information on each trial was recorded. RESULTS: Most of the trials were being conducted in the United States and completion of most of them was expected by May 2020. They were mostly on drugs and treatment, while a minority were on diagnostic tests. The analysis showed that hydroxychloroquine was investigated in most of the trials. The trials identified were categorized into five classes: a) diagnostic tests; b) therapeutics; c) biologics and vaccines; d) devices and products; and e) others. CONCLUSION: The trials identified have potential against COVID-19 that can be applied in treatment processes after the necessary investigations and experiments. Additionally, the items identified were organized in a proper way, which can assist in current research activities.


Subject(s)
Humans , Pneumonia, Viral , Clinical Trials as Topic , Coronavirus Infections , Pandemics , United States , Betacoronavirus , SARS-CoV-2 , COVID-19
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