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1.
J Foot Ankle Res ; 13(1): 38, 2020 Jun 23.
Artigo em Inglês | MEDLINE | ID: mdl-32576291

RESUMO

The recent and rapid emergence of COVID-19 infection has led to a flood of publications describing all aspects of the disease and its presentation. The appearance of chilblain-like lesions, in children and young adults has particularly caught the attention of healthcare professionals with an interest in the foot. With such a novel infection, demand for information is high at a time when evidence is scarce. Consequently, there has been a renaissance in the publication of case studies. This type of research, previously relegated from many mainstream journals, as a low level source of evidence, has permitted the rapid reporting, publication and dissemination of much needed clinical data which can be used as a foundation to inform further research and investigations about a new global infection.


Assuntos
Infecções por Coronavirus , Medicina Baseada em Evidências , Pandemias , Pneumonia Viral , Publicações/tendências , Projetos de Pesquisa/tendências , Betacoronavirus/isolamento & purificação , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/fisiopatologia , Infecções por Coronavirus/terapia , Gerenciamento Clínico , Medicina Baseada em Evidências/métodos , Medicina Baseada em Evidências/tendências , Doenças do Pé/epidemiologia , Doenças do Pé/terapia , Humanos , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Pneumonia Viral/fisiopatologia , Pneumonia Viral/terapia
2.
Drug Des Devel Ther ; 14: 2159-2164, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32581514

RESUMO

Objective: This study aimed to evaluate the fundamental characteristics of coronavirus disease (COVID-19) clinical trials registered in China. Methods: COVID-19 clinical trials registered in China were analyzed from databases on ChiCTR and ClinicalTrials.gov. The study designs, samples, primary end points, and intervention measures were evaluated. Results: In total, 262 intervention clinical trials were retrieved on March 10, 2020. Overall, 181 (69.1%) trials involved two groups, 200 (76.3%) trials were randomized parallel trials, 24 (9.2%) trials were double blind, and 60.3% of trials included ≤100 participants. Sixty (22.9%) trials considered symptom improvement as the primary endpoint and 43 (16.4%) trials considered the rate or time at which the subjects became virus-free as the primary endpoint. Of 262 intervention studies, chemical drugs and biological products were studied in 105 (40.1%) intervention studies, of which antiviral drugs accounted for 15.3% and malaria drugs accounted for 8.4% of the studies. Among all trials, 27.9% of the studies used traditional Chinese medicine (TCM), 10.3% used cell therapy, and 5.0% used plasma therapy. Conclusion: This study is the first snapshot of the landscape of COVID-19 clinical trials registered in China and provided the basic features of clinical trial designs for the treatment and prevention of COVID-19 to offer useful information to guide future clinical trials on COVID-19 in other countries.


Assuntos
Antivirais/uso terapêutico , Betacoronavirus/efeitos dos fármacos , Ensaios Clínicos como Assunto , Infecções por Coronavirus/tratamento farmacológico , Pneumonia Viral/tratamento farmacológico , Projetos de Pesquisa/tendências , Antivirais/efeitos adversos , Betacoronavirus/patogenicidade , China/epidemiologia , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/virologia , Interações Hospedeiro-Patógeno , Humanos , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/mortalidade , Pneumonia Viral/virologia , Indução de Remissão , Fatores de Tempo , Resultado do Tratamento , Carga Viral/tendências
5.
Cell Host Microbe ; 27(5): 695-698, 2020 05 13.
Artigo em Inglês | MEDLINE | ID: mdl-32407707

RESUMO

As scientists consider SARS-CoV-2 vaccine design, we discuss problems that may be encountered and how to tackle them by what we term "rational vaccine design." We further discuss approaches to pan-coronavirus vaccines. We draw on experiences from recent research on several viruses including HIV and influenza, as well as coronaviruses.


Assuntos
Anticorpos Antivirais/imunologia , Antígenos Virais/imunologia , Betacoronavirus/imunologia , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinas Virais/imunologia , Vacinas contra a AIDS/imunologia , Vacinas contra a AIDS/normas , Infecções por Coronavirus/imunologia , Humanos , Vacinas contra Influenza/imunologia , Vacinas contra Influenza/normas , Pneumonia Viral/imunologia , Projetos de Pesquisa/tendências
6.
Altern Lab Anim ; 48(1): 40-46, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32316753

RESUMO

In the 60 years since the publication of The Principles of Humane Experimental Technique, the Three Rs (Reduction, Refinement, Replacement) proposed by William Russell and Rex Burch have gradually been accepted throughout the world as ways of facing up to the ethical and scientific dilemmas involved in animal experimentation. However, the scale of animal use and the use of animals as models of humans has continued, seemingly almost unchallenged in much of the scientific community, despite the warnings about models, species differences and human variation spelled out in the The Principles. In this Comment, it is proposed that it is time to move away from the animal welfare focus of the Three Rs, in favour of a wider concept of humanity, which also embraces human welfare. In addition, since less than 10% of new drugs successfully pass from preclinical testing, which is highly reliant on animal procedures, to acceptance for clinical use, it is argued that the aim should not be to directly replace animal testing with non-animal methods with similar aims and which produce similar results, but to take advantage of developments in cell and molecular biology and in computer science, to devise new, different, appropriate, specific and intelligent stand-alone preclinical testing strategies that are applicable to particular human situations.


Assuntos
Experimentação Animal , Alternativas aos Testes com Animais , Bem-Estar do Animal , Projetos de Pesquisa , Experimentação Animal/normas , Alternativas aos Testes com Animais/tendências , Bem-Estar do Animal/normas , Bem-Estar do Animal/tendências , Animais , Humanos , Editoração , Projetos de Pesquisa/tendências
7.
Acad Med ; 95(5): 695-699, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32345881

RESUMO

An understanding of the diversity of perspectives within the research paradigms of health professions education (HPE) is essential for rigorous research design and more purposeful engagement with the contributions of others. In this article, the authors explicitly discuss the underlying assumptions, notions of good scholarship, and shortcomings of the postpositivism research paradigm. While postpositivism is likely one of the more familiar paradigms within HPE research, it is rarely formally or explicitly described. Drawing on key literature and contemporary examples, the authors describe the ontology, epistemology, methodologies, axiology, signs of rigor, and common critiques of postpositivism. A case study provides the focus for a practical illustration of how a postpositivist approach to education research could be applied. Suggestions for further reading are provided for those who are keen to delve deeper into the history and key tenants of the postpositivist stance.


Assuntos
Ocupações em Saúde/educação , Projetos de Pesquisa/tendências , Pesquisa/normas , Humanos , Pesquisa/tendências , Projetos de Pesquisa/normas
8.
J Nurs Adm ; 50(4): 187-189, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32195911

RESUMO

Conducting high-quality research in hospitals can be challenging. Surveys are a cost-effective method to collect data and conduct research studies in hospitals. However, survey response rates can present a challenge to researchers. This article explores targeted techniques that can be used to maximize the survey response rates among nurses and nurse managers.


Assuntos
Enfermeiras Administradoras/organização & administração , Recursos Humanos de Enfermagem no Hospital/organização & administração , Projetos de Pesquisa/tendências , Participação dos Interessados/psicologia , Inquéritos e Questionários , Coleta de Dados , Hospitais , Humanos , Internet
10.
Altern Lab Anim ; 47(3-4): 128-139, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31838868

RESUMO

Major depressive disorder (MDD) is the most severe form of depression and the leading cause of disability worldwide. When considering research approaches aimed at understanding MDD, it is important that their effectiveness is evaluated. Here, we assessed the effectiveness of original studies on MDD by rating their contributions to subsequent medical papers on the subject, and we compared the respective contribution of findings from non-human primate (NHP) studies and from human-based in vitro or in silico research approaches. For each publication, we conducted a quantitative citation analysis and a systematic qualitative analysis of the citations. In the majority of cases, human-based research approaches (both in silico and in vitro) received more citations in subsequent human research papers than did NHP studies. In addition, the human-based approaches were considered to be more relevant to the hypotheses and/or to the methods featured in the citing papers. The results of this study suggest that studies based on in silico and in vitro approaches are taken into account by medical researchers more often than are NHP-based approaches. In addition, these human-based approaches are usually cheaper and less ethically contentious than NHP studies. Therefore, we suggest that the traditional animal-based approach for testing medical hypotheses should be revised, and more opportunities created for further developing human-relevant innovative techniques.


Assuntos
Transtorno Depressivo Maior , Primatas , Projetos de Pesquisa , Animais , Simulação por Computador , Modelos Animais de Doenças , Humanos , Técnicas In Vitro , Projetos de Pesquisa/normas , Projetos de Pesquisa/tendências
11.
Artigo em Inglês | MEDLINE | ID: mdl-31817253

RESUMO

The extensive use of antimicrobials in animal farms poses serious safety hazards to both the environment and public health, and this trend is likely to continue. Antimicrobial resistance genes (ARGs) are a class of emerging pollutants that are difficult to remove once introduced. Understanding the environmental transfer of antimicrobial-resistant bacteria (ARB) and ARGs is pivotal for creating control measures. In this review, we summarize the research progress on the spread and detection of ARB and ARG pollution related to animal husbandry. Molecular methods such as high-throughput sequencing have greatly enriched the information about ARB communities. However, it remains challenging to delineate mechanisms regarding ARG induction, transmission, and tempo-spatial changes in the whole process, from animal husbandry to multiple ecosystems. As a result, future research should be more focused on the mechanisms of ARG induction, transmission, and control. We also expect that future research will rely more heavily on metagenomic -analysis, metatranscriptomic sequencing, and multi-omics technologies.


Assuntos
Criação de Animais Domésticos/métodos , Antibacterianos/farmacologia , Bactérias/genética , Farmacorresistência Bacteriana/genética , Genes Bacterianos/efeitos dos fármacos , Invenções/tendências , Projetos de Pesquisa/tendências , Animais , Bactérias/efeitos dos fármacos , Farmacorresistência Bacteriana/efeitos dos fármacos , Sequenciamento de Nucleotídeos em Larga Escala , Metagenômica/métodos , Metagenômica/tendências
12.
Int J Mol Sci ; 20(23)2019 Nov 30.
Artigo em Inglês | MEDLINE | ID: mdl-31801303

RESUMO

Nanoparticles are becoming an increasingly popular tool for biomedical imaging and drug delivery. While the prevalence of nanoparticle drug-delivery systems reported in the literature increases yearly, relatively little translation from the bench to the bedside has occurred. It is crucial for the scientific community to recognize this shortcoming and re-evaluate standard practices in the field, to increase clinical translatability. Currently, nanoparticle drug-delivery systems are designed to increase circulation, target disease states, enhance retention in diseased tissues, and provide targeted payload release. To manage these demands, the surface of the particle is often modified with a variety of chemical and biological moieties, including PEG, tumor targeting peptides, and environmentally responsive linkers. Regardless of the surface modifications, the nano-bio interface, which is mediated by opsonization and the protein corona, often remains problematic. While fabrication and assessment techniques for nanoparticles have seen continued advances, a thorough evaluation of the particle's interaction with the immune system has lagged behind, seemingly taking a backseat to particle characterization. This review explores current limitations in the evaluation of surface-modified nanoparticle biocompatibility and in vivo model selection, suggesting a promising standardized pathway to clinical translation.


Assuntos
Sistemas de Liberação de Medicamentos/métodos , Nanopartículas/uso terapêutico , Coroa de Proteína/química , Projetos de Pesquisa/tendências , Pesquisa Médica Translacional/métodos , Acromegalia/diagnóstico por imagem , Acromegalia/imunologia , Acromegalia/patologia , Acromegalia/terapia , Anemia/diagnóstico por imagem , Anemia/imunologia , Anemia/patologia , Anemia/terapia , Animais , Bibliometria , Diagnóstico por Imagem/métodos , Modelos Animais de Doenças , Vias de Administração de Medicamentos , Humanos , Interações Hidrofóbicas e Hidrofílicas , Esclerose Múltipla/diagnóstico por imagem , Esclerose Múltipla/imunologia , Esclerose Múltipla/patologia , Esclerose Múltipla/terapia , Nanopartículas/química , Nanopartículas/ultraestrutura , Neoplasias/diagnóstico por imagem , Neoplasias/imunologia , Neoplasias/patologia , Neoplasias/terapia , Polietilenoglicóis/química , Coroa de Proteína/imunologia , Propriedades de Superfície
13.
Handb Exp Pharmacol ; 260: 371-397, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31707472

RESUMO

Clinical trials have been conducted since 500 BC. Currently, the methodological gold standard is the randomized controlled clinical trial, introduced by Austin Bradford Hill. This standard has produced enormous amounts of high-quality evidence, resulting in evidence-based clinical guidelines for physicians. However, the current trial paradigm needs to evolve because of the ongoing decrease of the incidence of hard endpoints and spiraling trial costs. While new trial designs, such as adaptive clinical trials, may lead to an increase in efficiency and decrease in costs, we propose a shift towards value-based trial design: a paradigm that mirrors value-based thinking in business and health care. Value-based clinical trials will use technology to focus more on symptoms and endpoints that patients care about, will incorporate fewer research centers, and will measure a state or consequence of disease at home or at work. Furthermore, they will measure the subjective experience of subjects in relation to other objective measurements. Ideally, the endpoints are suitable for individual assessment of the effect of an intervention. The value-based clinical trial of the future will have a low burden for participants, allowing for the inclusion of neglected populations such as children and the elderly, will be data-rich due to a high frequency of measurements, and can be conducted with technology that is already available.


Assuntos
Ensaios Clínicos como Assunto/normas , Projetos de Pesquisa/tendências , Humanos
14.
Nature ; 575(7781): 137-146, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31695204

RESUMO

The goal of sex and gender analysis is to promote rigorous, reproducible and responsible science. Incorporating sex and gender analysis into experimental design has enabled advancements across many disciplines, such as improved treatment of heart disease and insights into the societal impact of algorithmic bias. Here we discuss the potential for sex and gender analysis to foster scientific discovery, improve experimental efficiency and enable social equality. We provide a roadmap for sex and gender analysis across scientific disciplines and call on researchers, funding agencies, peer-reviewed journals and universities to coordinate efforts to implement robust methods of sex and gender analysis.


Assuntos
Engenharia/métodos , Engenharia/normas , Projetos de Pesquisa/normas , Projetos de Pesquisa/tendências , Ciência/métodos , Ciência/normas , Caracteres Sexuais , Fatores Sexuais , Animais , Inteligência Artificial , Feminino , Humanos , Masculino , Terapia de Alvo Molecular , Reprodutibilidade dos Testes , Tamanho da Amostra
15.
PLoS Med ; 16(11): e1002966, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31751330

RESUMO

BACKGROUND: Rare diseases affect as many as 60 million people in the United States and Europe. However, most rare diseases lack effective therapies and are in critical need of clinical research. Our objective was to determine the frequency of noncompletion and nonpublication of trials studying rare diseases. METHODS AND FINDINGS: We conducted a cross-sectional analysis of randomized clinical trials studying rare diseases as defined by the Genetic and Rare Disease Information Center database that were registered in ClinicalTrials.gov between January 1, 2010, and December 31, 2012, and completed or discontinued by December 31, 2014. Our main outcome measures were the frequency of trial noncompletion and, among completed studies, frequency of trial nonpublication at 2 and 4 years following trial completion. Reasons for discontinuation were extracted from the registry, and trial sponsors were contacted for additional information, as needed. Two independent investigators performed publication searches for each trial in PubMed, EMBASE, and GoogleScholar, allowing for a minimum of 45 months between trial completion and publication. When a publication could not be identified, trial sponsors were contacted to confirm publication status. The impact of funding source on trial noncompletion was assessed with multivariable logistic regression, and the effect on time to publication was examined with Cox proportional hazards regression. Control variables included intervention type, trial phase, masking, enrollment, and study population. We analyzed 659 rare disease trials accounting for 70,305 enrolled patients. Industry was the primary funder for 327 trials (49.6%) and academic institutions for 184 trials (27.9%). There were 79 trials (12.0%) focused on pediatric populations. A total of 199 trials (30.2%) were discontinued. Lack of patient accrual (n = 64, 32.1%) and informative termination (n = 41, 20.6%) were the most common reasons for trial noncompletion. Among completed trials, 306 (66.5%) remained unpublished at 2 years and 142 (31.5%) at 4 years. In multivariable analyses, industry-funded trials were less likely to be discontinued than trials funded by healthcare centers (odds ratio [OR] 2.42; 95% confidence interval [CI] 1.34-4.39, P = 0.003). We found no significant association between funding source and time to publication. A total of 18,148 patients were enrolled in trials that were discontinued or unpublished 4 years after completion. A potential limitation of our study is that certain interventional trials for rare diseases may not have been registered in ClinicalTrials.gov, in particular Phase 0 and Phase I trials, which are not required to be registered. CONCLUSIONS: In this study, over half of clinical trials initiated for rare diseases were either discontinued or not published 4 years after completion, resulting in large numbers of patients with rare diseases exposed to interventions that did not lead to informative findings. Concerted efforts are needed to ensure that participation of patients in rare disease trials advances scientific knowledge and treatments for rare diseases.


Assuntos
Editoração/tendências , Doenças Raras/etiologia , Projetos de Pesquisa/tendências , Ensaios Clínicos como Assunto , Estudos Transversais , Bases de Dados Factuais , Humanos , Modelos Logísticos , Manuscritos como Assunto , Razão de Chances , Publicações , Sistema de Registros , Estados Unidos
18.
Nat Rev Urol ; 16(12): 722-733, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31605037

RESUMO

Well-designed clinical trials in urological oncology help to guide treatment decisions and aid in counselling patients, ultimately serving to improve outcomes. Since the term evidence-based medicine was first used by Gordon Guyatt in 1991, a renewed emphasis on methodology, transparent trial design and study reporting has helped to improve clinical research and in turn, the landscape of medical literature. Novel clinical trial designs (including multi-arm, multistage trials, basket and umbrella studies and research from big data sources, such as electronic health records, administrative claims databases and quality monitoring registries) are well suited to advance innovation in urological oncology. Existing urological clinical trials are often limited by small numbers, are statistically underpowered and many face difficulties with accrual. Thus, efforts to improve trial design are of considerable importance. The development and use of standard outcome sets and adherence to reporting guidelines offer researchers the opportunity to guide value-oriented care, minimize research waste and efficiently identify solutions to the unanswered questions in urology cancer care.


Assuntos
Ensaios Clínicos como Assunto , Neoplasias Urológicas , Ensaios Clínicos como Assunto/legislação & jurisprudência , Previsões , Humanos , Oncologia , Projetos de Pesquisa/tendências , Estados Unidos , Urologia
19.
Adv Exp Med Biol ; 1141: 203-240, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31571166

RESUMO

Transporters play an important role in the absorption, distribution, metabolism, and excretion (ADME) of drugs. In recent years, various in vitro, in situ/ex vivo, and in vivo methods have been established for studying transporter function and drug-transporter interaction. In this chapter, the major types of in vitro models for drug transport studies comprise membrane-based assays, cell-based assays (such as primary cell cultures, immortalized cell lines), and transporter-transfected cell lines with single transporters or multiple transporters. In situ/ex vivo models comprise isolated and perfused organs or tissues. In vivo models comprise transporter gene knockout models, natural mutant animal models, and humanized animal models. This chapter would be focused on the methods for the study of drug transporters in vitro, in situ/ex vivo, and in vivo. The applications, advantages, or limitations of each model and emerging technologies are also mentioned in this chapter.


Assuntos
Proteínas de Membrana Transportadoras , Projetos de Pesquisa , Animais , Transporte Biológico , Linhagem Celular , Interações Medicamentosas , Humanos , Técnicas In Vitro , Projetos de Pesquisa/tendências
20.
Vet J ; 252: 105370, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31554586

RESUMO

The estimation of long-standing pain in companion animals through the measurement of different dimensions impacted by pain is a fundamental requirement if pain management, and pain therapeutic development, are to advance. Although pain management in veterinary medicine has advanced considerably in the last 20 years, there is much critical work to do in the area of measurement of chronic pain. To date, most work has centered on musculoskeletal pain, and has been focused around the measurement of limb use and the development of owner-completed questionnaires, or clinical metrology instruments (CMI). Recent areas of research have extended to developing measures of activity, sensory function (quantitative sensory testing; nociceptive withdrawal reflexes), and quality of life (QoL). Across all these areas, more data on validity are needed, and studies should be extended to other painful disease states. By necessity, assessing measurement tools requires testing in field studies, which incur considerable time and expense. Facilitating these studies could be optimized with a collaborative (industry, academia and private practice) approach, and the utility of the information produced from all field studies would be enhanced by full and transparent reporting and data sharing, including data already generated by industry in the form of studies submitted to the regulatory authorities.


Assuntos
Dor Crônica/veterinária , Projetos de Pesquisa/tendências , Medicina Veterinária/tendências , Animais , Gatos , Dor Crônica/diagnóstico , Cães , Manejo da Dor/veterinária
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