356 research outputs found
Transcultural adaptation of the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) into Brazilian Portuguese
INTRODUCTION: The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is an index of primary Sjögren's syndrome (PSS) systemic activity. OBJECTIVE: To perform the ESSDAI transcultural adaptation into Brazilian Portuguese. METHOD: This was a cross-sectional study with 62 patients with PSS according to the criteria of the 2002 American-European Consensus. Six stages were conducted: conceptual, item, semantic, operational, functional, and measurement equivalences (interobserver reproducibility and construct validity). For the validity assessment, the ESSDAI was compared with the Physician's Global Assessment (PhGA), the Sjögren's Syndrome Disease Activity Index (SSDAI), and the Sjögren's Systemic Clinical Activity Index (SCAI). Patients were classified by a specialist physician into two groups according to disease activity (active and inactive), and according to the intention-to-treat (increase in therapy and no increase in therapy). The ESSDAI was tested in these groups. The following statistical tests were used: intraclass correlation coefficient (ICC), Bland-Altman plot for reproducibility, and Spearman's correlation coefficient (r s) and Mann-Whitney's test for validity (P < 0.05 and 95% CI). RESULTS: The mean ESSDAI score was 4.95 ± 6.73. The reproducibility obtained a strong ICC of 0.89 and good agreement. When compared with other indices, it showed a strong r s with PhGA (0.83; P < 0.000), a moderate r s with SSDAI (0.658; P < 0.000) and a weak r s with the SCAI (0.411; P = 0.001). The group active and the groupincrease in therapy had higher ESSDAI values (P = 0.000). CONCLUSION: The Brazilian Portuguese version of ESSDAI was shown to be adaptable, reproducible, and valid for this language.INTRODUĂĂO: O EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Ă© um Ăndice de atividade sistĂȘmica da sĂndrome de Sjögren primĂĄria (SSP). OBJETIVO: Realizar a adaptação transcultural do ESSDAI para a lĂngua portuguesa. MĂTODO: Estudo transversal com 62 pacientes com SSP de acordo com consenso europeu-americano de 2002. Foram realizadas seis etapas: equivalĂȘncia conceitual, de item, semĂąntica, operacional, funcional e de mensuração (reprodutibilidade interobservador e a validade de constructo). Para a validade, o ESSDAI foi comparado com a avaliação global do mĂ©dico (PhGA), o Sjögren's Syndrome Disease Activity Index (SSDAI) e o Sjögren's Systemic Clinical Activity Index (SCAI). Os pacientes foram classificados por um mĂ©dico especialista conforme a atividade da doença em dois grupos, ativo e inativo, e conforme a intenção de tratar nos grupos aumento de terapia e sem aumento de terapia. O ESSDAI foi testado nesses grupos. Utilizou-se os testes estatĂsticos: coeficiente de correlação intraclasse (CCI) e mĂ©todo de Bland Altman para a reprodutibilidade; e coeficiente de Spearman (r s) e teste de Mann-Whitney para a validade (P < 0,05 e IC 95%). RESULTADOS: A mĂ©dia do ESSDAI foi de 4,95 ± 6,73. A reprodutibilidade obteve um forte CCI de 0,89 e boa concordĂąncia. Na comparação com outros Ăndices, apresentou forte coeficiente de Spearman com o PhGA (r s = 0,83; P < 0,000), moderado com o SSDAI (r s = 0,658 ; P < 0,000) e fraco com o SCAI (r s = 0,411; P = 0,001). O grupo ativo e o grupo com aumento de terapia obtiveram maiores valores de ESSDAI (P = 0,000). CONCLUSĂO: a versĂŁo em portuguĂȘs do ESSDAI mostrou ser adaptĂĄvel, reprodutĂvel e vĂĄlida para a lĂngua portuguesa.Universidade Federal do EspĂrito Santo Programa de PĂłs-graduação em SaĂșde ColetivaSanta Casa de MisericĂłrdia de VitĂłria Escola Superior de CiĂȘncias Departamento de ClĂnica MĂ©dicaHospital UniversitĂĄrio Cassiano AntĂŽnio de MoraesUniversidade Federal de SĂŁo Paulo (UNIFESP) Escola Paulista de MedicinaUniversidade Federal do EspĂrito Santo Departamento de ClĂnica MĂ©dicaHospital UniversitĂĄrio Cassiano AntĂŽnio de Moraes AmbulatĂłrio de ReumatologiaUniversidade Federal do EspĂrito SantoUniversidade Federal do EspĂrito Santo Programa de Mestrado Profissional de MedicinaUniversidade de Vila Velha Programa de PĂłs-Graduação em CiĂȘncias FarmacĂȘuticasUniversidade de SĂŁo Paulo Programa de PĂłs-Graduação em EnfermagemUNIFESP, EPMSciEL
Brazilian Sjogren's Syndrome Registry (BRASS) : a large Brazilian multicentric cohort of primary Sjogren's syndrome
Les droits disciplinaires des fonctions publiques : « unification », « harmonisation » ou « distanciation ». A propos de la loi du 26 avril 2016 relative à la déontologie et aux droits et obligations des fonctionnaires
The production of tt⟠, W+bb⟠and W+cc⟠is studied in the forward region of protonâproton collisions collected at a centre-of-mass energy of 8 TeV by the LHCb experiment, corresponding to an integrated luminosity of 1.98±0.02 fbâ1 . The W bosons are reconstructed in the decays WââÎœ , where â denotes muon or electron, while the b and c quarks are reconstructed as jets. All measured cross-sections are in agreement with next-to-leading-order Standard Model predictions.The production of , and is studied in the forward region of proton-proton collisions collected at a centre-of-mass energy of 8 TeV by the LHCb experiment, corresponding to an integrated luminosity of 1.98 0.02 \mbox{fb}^{-1}. The bosons are reconstructed in the decays , where denotes muon or electron, while the and quarks are reconstructed as jets. All measured cross-sections are in agreement with next-to-leading-order Standard Model predictions
Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.
BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5âĂâ1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1â-ârelative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. FINDINGS: Between April 23 and Nov 4, 2020, 23â848 participants were enrolled and 11â636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74â341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca
Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
Background
A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials.
Methods
This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5âĂâ1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1â-ârelative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674.
Findings
Between April 23 and Nov 4, 2020, 23â848 participants were enrolled and 11â636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0â75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4â97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8â80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74â341 person-months of safety follow-up (median 3·4 months, IQR 1·3â4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation.
Interpretation
ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials
Angular analysis of the B-0 -> K*(0) e(+) e(-) decay in the low-q(2) region
An angular analysis of the decay is performed using a data sample, corresponding to an integrated luminosity of 3.0 {\mbox{fb}^{-1}}, collected by the LHCb experiment in collisions at centre-of-mass energies of 7 and 8 TeV during 2011 and 2012. For the first time several observables are measured in the dielectron mass squared () interval between 0.002 and 1.120. The angular observables and which are related to the polarisation and to the lepton forward-backward asymmetry, are measured to be and , where the first uncertainty is statistical and the second systematic. The angular observables and which are sensitive to the photon polarisation in this range, are found to be and . The results are consistent with Standard Model predictions.An angular analysis of the B â K^{*}^{0} e e decay is performed using a data sample, corresponding to an integrated luminosity of 3.0 fb, collected by the LHCb experiment in pp collisions at centre-of-mass energies of 7 and 8 TeV during 2011 and 2012. For the first time several observables are measured in the dielectron mass squared (q) interval between 0.002 and 1.120 GeV /c. The angular observables F and A which are related to the K^{*}^{0} polarisation and to the lepton forward-backward asymmetry, are measured to be F = 0.16 ± 0.06 ± 0.03 and A â=â0.10â±â0.18â±â0.05, where the first uncertainty is statistical and the second systematic. The angular observables A and A which are sensitive to the photon polarisation in this q range, are found to be A â=âââ0.23â±â0.23â±â0.05 and A â=â0.14â±â0.22â±â0.05. The results are consistent with Standard Model predictions.An angular analysis of the decay is performed using a data sample, corresponding to an integrated luminosity of 3.0 {\mbox{fb}^{-1}}, collected by the LHCb experiment in collisions at centre-of-mass energies of 7 and 8 TeV during 2011 and 2012. For the first time several observables are measured in the dielectron mass squared () interval between 0.002 and 1.120. The angular observables and which are related to the polarisation and to the lepton forward-backward asymmetry, are measured to be and , where the first uncertainty is statistical and the second systematic. The angular observables and which are sensitive to the photon polarisation in this range, are found to be and . The results are consistent with Standard Model predictions
Observation of the B0 â Ï0Ï0 decay from an amplitude analysis of B0 â (Ï+Ïâ)(Ï+Ïâ) decays
Protonâproton collision data recorded in 2011 and 2012 by the LHCb experiment, corresponding to an integrated luminosity of 3.0 fbâ1 , are analysed to search for the charmless B0âÏ0Ï0 decay. More than 600 B0â(Ï+Ïâ)(Ï+Ïâ) signal decays are selected and used to perform an amplitude analysis, under the assumption of no CP violation in the decay, from which the B0âÏ0Ï0 decay is observed for the first time with 7.1 standard deviations significance. The fraction of B0âÏ0Ï0 decays yielding a longitudinally polarised final state is measured to be fL=0.745â0.058+0.048(stat)±0.034(syst) . The B0âÏ0Ï0 branching fraction, using the B0âÏKâ(892)0 decay as reference, is also reported as B(B0âÏ0Ï0)=(0.94±0.17(stat)±0.09(syst)±0.06(BF))Ă10â6
Measurement of the (eta c)(1S) production cross-section in proton-proton collisions via the decay (eta c)(1S) -> p(p)over-bar
The production of the state in proton-proton collisions is probed via its decay to the final state with the LHCb detector, in the rapidity range GeV/c. The cross-section for prompt production of mesons relative to the prompt cross-section is measured, for the first time, to be at a centre-of-mass energy TeV using data corresponding to an integrated luminosity of 0.7 fb, and at TeV using 2.0 fb. The uncertainties quoted are, in order, statistical, systematic, and that on the ratio of branching fractions of the and decays to the final state. In addition, the inclusive branching fraction of -hadron decays into mesons is measured, for the first time, to be , where the third uncertainty includes also the uncertainty on the inclusive branching fraction from -hadron decays. The difference between the and meson masses is determined to be MeV/c.The production of the state in proton-proton collisions is probed via its decay to the final state with the LHCb detector, in the rapidity range . The cross-section for prompt production of mesons relative to the prompt cross-section is measured, for the first time, to be at a centre-of-mass energy using data corresponding to an integrated luminosity of 0.7Â fb , and at using 2.0Â fb . The uncertainties quoted are, in order, statistical, systematic, and that on the ratio of branching fractions of the and decays to the final state. In addition, the inclusive branching fraction of -hadron decays into mesons is measured, for the first time, to be , where the third uncertainty includes also the uncertainty on the inclusive branching fraction from -hadron decays. The difference between the and meson masses is determined to be .The production of the state in proton-proton collisions is probed via its decay to the final state with the LHCb detector, in the rapidity range GeV/c. The cross-section for prompt production of mesons relative to the prompt cross-section is measured, for the first time, to be at a centre-of-mass energy TeV using data corresponding to an integrated luminosity of 0.7 fb, and at TeV using 2.0 fb. The uncertainties quoted are, in order, statistical, systematic, and that on the ratio of branching fractions of the and decays to the final state. In addition, the inclusive branching fraction of -hadron decays into mesons is measured, for the first time, to be , where the third uncertainty includes also the uncertainty on the inclusive branching fraction from -hadron decays. The difference between the and meson masses is determined to be MeV/c
A study of CP violation in B-+/- -> DK +/- and B-+/- -> D pi(+/-) decays with D -> (KSK +/-)-K-0 pi(-/+) final states
A first study of CP violation in the decay modes and , where labels a or meson and labels a or meson, is performed. The analysis uses the LHCb data set collected in collisions, corresponding to an integrated luminosity of 3 fb. The analysis is sensitive to the CP-violating CKM phase through seven observables: one charge asymmetry in each of the four modes and three ratios of the charge-integrated yields. The results are consistent with measurements of using other decay modes
Study of the rare B-s(0) and B-0 decays into the pi(+) pi(-) mu(+) mu(-) final state
A search for the rare decays and is performed in a data set corresponding to an integrated luminosity of 3.0 fb collected by the LHCb detector in proton-proton collisions at centre-of-mass energies of 7 and 8 TeV. Decay candidates with pion pairs that have invariant mass in the range 0.5-1.3 GeV/ and with muon pairs that do not originate from a resonance are considered. The first observation of the decay and the first evidence of the decay are obtained and the branching fractions are measured to be and , where the third uncertainty is due to the branching fraction of the decay , used as a normalisation.A search for the rare decays Bs0âÏ+ÏâÎŒ+ÎŒâ and B0âÏ+ÏâÎŒ+ÎŒâ is performed in a data set corresponding to an integrated luminosity of 3.0 fbâ1 collected by the LHCb detector in protonâproton collisions at centre-of-mass energies of 7 and 8 TeV . Decay candidates with pion pairs that have invariant mass in the range 0.5â1.3 GeV/c2 and with muon pairs that do not originate from a resonance are considered. The first observation of the decay Bs0âÏ+ÏâÎŒ+ÎŒâ and the first evidence of the decay B0âÏ+ÏâÎŒ+ÎŒâ are obtained and the branching fractions, restricted to the dipion-mass range considered, are measured to be B(Bs0âÏ+ÏâÎŒ+ÎŒâ)=(8.6±1.5 (stat)±0.7 (syst)±0.7(norm))Ă10â8 and B(B0âÏ+ÏâÎŒ+ÎŒâ)=(2.11±0.51(stat)±0.15(syst)±0.16(norm))Ă10â8 , where the third uncertainty is due to the branching fraction of the decay B0âJ/Ï(âÎŒ+ÎŒâ)Kâ(892)0(âK+Ïâ) , used as a normalisation.A search for the rare decays Bs0âÏ+ÏâÎŒ+ÎŒâ and B0âÏ+ÏâÎŒ+ÎŒâ is performed in a data set corresponding to an integrated luminosity of 3.0 fbâ1 collected by the LHCb detector in protonâproton collisions at centre-of-mass energies of 7 and 8 TeV . Decay candidates with pion pairs that have invariant mass in the range 0.5â1.3 GeV/c2 and with muon pairs that do not originate from a resonance are considered. The first observation of the decay Bs0âÏ+ÏâÎŒ+ÎŒâ and the first evidence of the decay B0âÏ+ÏâÎŒ+ÎŒâ are obtained and the branching fractions, restricted to the dipion-mass range considered, are measured to be B(Bs0âÏ+ÏâÎŒ+ÎŒâ)=(8.6±1.5 (stat)±0.7 (syst)±0.7(norm))Ă10â8 and B(B0âÏ+ÏâÎŒ+ÎŒâ)=(2.11±0.51(stat)±0.15(syst)±0.16(norm))Ă10â8 , where the third uncertainty is due to the branching fraction of the decay B0âJ/Ï(âÎŒ+ÎŒâ)Kâ(892)0(âK+Ïâ) , used as a normalisation.A search for the rare decays and is performed in a data set corresponding to an integrated luminosity of 3.0 fb collected by the LHCb detector in proton-proton collisions at centre-of-mass energies of 7 and 8 TeV. Decay candidates with pion pairs that have invariant mass in the range 0.5-1.3 GeV/ and with muon pairs that do not originate from a resonance are considered. The first observation of the decay and the first evidence of the decay are obtained and the branching fractions, restricted to the dipion-mass range considered, are measured to be and , where the third uncertainty is due to the branching fraction of the decay , used as a normalisation
- âŠ