3 research outputs found

    Revista de logopedia, foniatría y audiología

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    Resumen en inglés. Resumen basado en el de la publicaciónExposición de los principios básicos del aprendizaje motor, sus fases y pautas de administración, centrándose en la aplicación de estos aspectos al tratamiento de personas con problemas de voz de origen neurodegenerativo. Se analiza también cómo las teorías del aprendizaje motor son aplicadas en el método de Tratamiento Vocal Intensivo (LSVT) para el tratamiento de los problemas fonatorios de enfermos de Parkinson, permitiendo resultados terapéuticos por encima del nivel previo al tratamientoES

    Revista de logopedia, foniatría y audiología

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    Resumen en inglésSe reflexiona sobre el tratamiento de los trastornos de la voz en las enfermedades neurodegenerativas. Por un lado, se exponen los factores que favorecen la eficacia del tratamiento de la disfonía en las enfermedades neurodegenerativas. Estos son: la precocidad en la intervención y la planificación específica de los objetivos y recursos terapéuticos en función de los factores contextuales de cada caso. Por otro lado, se explican unos protocolos de intervención utilizados para paliar los tres tipos de déficits fonorrespiratorios más comunes en esta clase de enfermedadesES

    Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection: a double-blind, placebo-controlled, randomised clinical trialResearch in context

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    Summary: Background: Anti-COVID-19 hyperimmune immunoglobulin (hIG) can provide standardized and controlled antibody content. Data from controlled clinical trials using hIG for the prevention or treatment of COVID-19 outpatients have not been reported. We assessed the safety and efficacy of subcutaneous anti-COVID-19 hyperimmune immunoglobulin 20% (C19-IG20%) compared to placebo in preventing development of symptomatic COVID-19 in asymptomatic individuals with SARS-CoV-2 infection. Methods: We did a multicentre, randomized, double-blind, placebo-controlled trial, in asymptomatic unvaccinated adults (≥18 years of age) with confirmed SARS-CoV-2 infection within 5 days between April 28 and December 27, 2021. Participants were randomly assigned (1:1:1) to receive a blinded subcutaneous infusion of 10 mL with 1 g or 2 g of C19-IG20%, or an equivalent volume of saline as placebo. The primary endpoint was the proportion of participants who remained asymptomatic through day 14 after infusion. Secondary endpoints included the proportion of individuals who required oxygen supplementation, any medically attended visit, hospitalisation, or ICU, and viral load reduction and viral clearance in nasopharyngeal swabs. Safety was assessed as the proportion of patients with adverse events. The trial was terminated early due to a lack of potential benefit in the target population in a planned interim analysis conducted in December 2021. ClinicalTrials.gov registry: NCT04847141. Findings: 461 individuals (mean age 39.6 years [SD 12.8]) were randomized and received the intervention within a mean of 3.1 (SD 1.27) days from a positive SARS-CoV-2 test. In the prespecified modified intention-to-treat analysis that included only participants who received a subcutaneous infusion, the primary outcome occurred in 59.9% (91/152) of participants receiving 1 g C19-IG20%, 64.7% (99/153) receiving 2 g, and 63.5% (99/156) receiving placebo (difference in proportions 1 g C19-IG20% vs. placebo, −3.6%; 95% CI -14.6% to 7.3%, p = 0.53; 2 g C19-IG20% vs placebo, 1.1%; −9.6% to 11.9%, p = 0.85). None of the secondary clinical efficacy endpoints or virological endpoints were significantly different between study groups. Adverse event rate was similar between groups, and no severe or life-threatening adverse events related to investigational product infusion were reported. Interpretation: Our findings suggested that administration of subcutaneous human hyperimmune immunoglobulin C19-IG20% to asymptomatic individuals with SARS-CoV-2 infection was safe but did not prevent development of symptomatic COVID-19. Funding: Grifols
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