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1.
Trials ; 23(1): 92, 2022 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-35101094

RESUMO

The SARS-CoV-2 enters into the human body mainly through the nasal epithelial cells. Prevention of SARS-CoV-2 infection at the point of nasal entry is a novel strategy that has the potential to help contain the ongoing pandemic. BioBlock is a nasal spray of anti-SARS-CoV-2 preparation based on virus-neutralising antibodies prepared from colostrum from cows immunised with SARS-CoV-2 spike protein. This triple-blind placebo-controlled cluster randomised parallel trial seeks to evaluate the efficacy of a BioBlock spray in the prevention and treatment of SARS-CoV-2 infection. Laboratory-confirmed COVID-19 cases and their household members will be randomly allocated to each of either the intervention (BioBlock nasal spray) or the placebo (nasal spray) arms. The intervention is a 14-day course of nasal spray used by index case and household contacts. In most countries, those with confirmed or suspected infections are requisitioned to isolate at home, putting other members of their household at risk of infection. Therefore, in parallel to the need of household transmission prevention measures, households also present as a good model for infection transmission studies, allowing for the testing of several close contact transmission prevention study hypotheses. Our hope is that if the trial results are encouraging, this will provide new and additional COVID-19 prevention strategies. TRIAL REGISTRATION: ISRCTN48554326 Registered on June 14, 2021.


Assuntos
COVID-19 , Animais , Bovinos , Colostro , Feminino , Humanos , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Glicoproteína da Espícula de Coronavírus
2.
J Law Med Ethics ; 44(1): 20-3, 2016 03.
Artigo em Inglês | MEDLINE | ID: mdl-27256120

RESUMO

Estonia is a democratic, parliamentary republic with a health care system that is built on the principle of compulsory, solidarity-based insurance and the all-round availability of services of private service providers. Estonia has specific biobank legislation as well as oversight via data protection laws. Its population-based biobank, the Estonian Genome Center (EGCUT), established in 2001, is one of the largest biobanks in Europe, and its database may be used only for scientific research, public health research, and statistics. The EGCUT can issue data to a third party, but only in coded form. This comprehensive database of genotypic, phenotypic, health, and genealogical information represents about 5% of Estonia's adult population, and is the largest cohort ever gathered in Estonia. Government approval is required for international data sharing, and sharing can be further limited by the requirement of ethics approval and permission from Estonian government.


Assuntos
Bancos de Espécimes Biológicos , Saúde Pública , Bases de Dados Factuais , Estônia , Europa (Continente) , Humanos
3.
Ann Rheum Dis ; 73(12): 2130-6, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-23989986

RESUMO

OBJECTIVES: Osteoarthritis (OA) is the most common form of arthritis with a clear genetic component. To identify novel loci associated with hip OA we performed a meta-analysis of genome-wide association studies (GWAS) on European subjects. METHODS: We performed a two-stage meta-analysis on more than 78,000 participants. In stage 1, we synthesised data from eight GWAS whereas data from 10 centres were used for 'in silico' or 'de novo' replication. Besides the main analysis, a stratified by sex analysis was performed to detect possible sex-specific signals. Meta-analysis was performed using inverse-variance fixed effects models. A random effects approach was also used. RESULTS: We accumulated 11,277 cases of radiographic and symptomatic hip OA. We prioritised eight single nucleotide polymorphism (SNPs) for follow-up in the discovery stage (4349 OA cases); five from the combined analysis, two male specific and one female specific. One locus, at 20q13, represented by rs6094710 (minor allele frequency (MAF) 4%) near the NCOA3 (nuclear receptor coactivator 3) gene, reached genome-wide significance level with p=7.9×10(-9) and OR=1.28 (95% CI 1.18 to 1.39) in the combined analysis of discovery (p=5.6×10(-8)) and follow-up studies (p=7.3×10(-4)). We showed that this gene is expressed in articular cartilage and its expression was significantly reduced in OA-affected cartilage. Moreover, two loci remained suggestive associated; rs5009270 at 7q31 (MAF 30%, p=9.9×10(-7), OR=1.10) and rs3757837 at 7p13 (MAF 6%, p=2.2×10(-6), OR=1.27 in male specific analysis). CONCLUSIONS: Novel genetic loci for hip OA were found in this meta-analysis of GWAS.


Assuntos
Osteoartrite do Quadril/genética , Proteína Quinase Tipo 2 Dependente de Cálcio-Calmodulina/genética , Feminino , Frequência do Gene , Predisposição Genética para Doença , Estudo de Associação Genômica Ampla , Proteínas HMGN/genética , Proteínas de Homeodomínio/genética , Humanos , Proteínas Imediatamente Precoces/genética , Masculino , Coativador 3 de Receptor Nuclear/genética , Polimorfismo de Nucleotídeo Único , Proteínas Serina-Treonina Quinases/genética , Proteínas Tirosina Quinases/genética , Fatores Sexuais , População Branca/genética , Quinases Dyrk
4.
Sci Eng Ethics ; 20(1): 99-109, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-23456142

RESUMO

Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union (Eastern EU) and South-East European countries (South-East Europe) that are not members of the European Union. The most common ethical issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors' conflicts of interest and registration of clinical trials were the least common ethical policies. Three aspects were significantly more common in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals' ethical policies calls for further research and active measures to harmonize policies across journals.


Assuntos
Pesquisa Biomédica/ética , Políticas Editoriais , Publicações Periódicas como Assunto/ética , Editoração/ética , Conflito de Interesses , Direitos Autorais , Ética em Pesquisa , Europa Oriental , União Europeia , Humanos , Revisão da Pesquisa por Pares
5.
Am J Hum Genet ; 89(3): 446-50, 2011 Sep 09.
Artigo em Inglês | MEDLINE | ID: mdl-21871595

RESUMO

Osteoarthritis (OA) is a prevalent, heritable degenerative joint disease with a substantial public health impact. We used a 1000-Genomes-Project-based imputation in a genome-wide association scan for osteoarthritis (3177 OA cases and 4894 controls) to detect a previously unidentified risk locus. We discovered a small disease-associated set of variants on chromosome 13. Through large-scale replication, we establish a robust association with SNPs in MCF2L (rs11842874, combined odds ratio [95% confidence interval] 1.17 [1.11-1.23], p = 2.1 × 10(-8)) across a total of 19,041 OA cases and 24,504 controls of European descent. This risk locus represents the third established signal for OA overall. MCF2L regulates a nerve growth factor (NGF), and treatment with a humanized monoclonal antibody against NGF is associated with reduction in pain and improvement in function for knee OA patients.


Assuntos
Cromossomos Humanos Par 13/genética , Predisposição Genética para Doença/genética , Fatores de Troca do Nucleotídeo Guanina/genética , Osteoartrite/genética , Anticorpos Monoclonais/uso terapêutico , Estudo de Associação Genômica Ampla , Fatores de Troca do Nucleotídeo Guanina/metabolismo , Humanos , Fator de Crescimento Neural/imunologia , Fator de Crescimento Neural/metabolismo , Razão de Chances , Osteoartrite/imunologia , Polimorfismo de Nucleotídeo Único/genética , Fatores de Troca de Nucleotídeo Guanina Rho , População Branca/genética
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