Early use of corticosteroids in non-critical patients with COVID-19 pneumonia (PREDCOVID): a structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: To evaluate the efficacy of early treatment with prednisone to decrease the progression of COVID-19 pneumonia. TRIAL DESIGN: This is a pragmatic, non-blinded, randomized, two arms, parallel trial. PARTICIPANTS: Patients between 18 and 90 years, with COVID-19 pneumonia, confirmed by RT PCR. The setting for the trial is the Hospital Santiago Oriente which is a secondary level hospital with an emergency room, intensive care, and all basic specialties of medicine. INCLUSION CRITERIA: 18 years or more COVID-19 confirmed by RT-PCR Oxygen requirements up to 35% by venturi mask or 5 liters per minute by nasal cannula (approximately FiO2 40%) Consent form signed Exclusion Criteria: Previous steroid use for more than 48 hours. Pregnancy Chronic respiratory failure Requirements of mechanical ventilation (invasive or no invasive) Chronic liver damage Child Pugh B or C Chronic kidney disease stage IV or V. Immunosuppressed Participation in another trial. INTERVENTION AND COMPARATOR: Experimental arm Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8. Usual care defined by the attending physician. Control arm No intervention. Usual care defined by the attending physician. MAIN OUTCOMES: Primary outcome Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28 Secondary outcomes (followed until day 28). Time to respiratory deterioration Incidence of patients requiring mechanical ventilation: Number of days on mechanical ventilation Special emphasis will be placed on observing the following serious adverse events Deterioration of the glycemic profile that requires the use of insulin Delirium Incidence of hospital infections (pneumonia, urinary tract infection, device associated infections) Cumulative incidence of grade 3 and 4 adverse events (AE). Interruption or temporary suspension of treatment for any reason RANDOMISATION: Randomisation in permuted block. Computer generated random numbers in an allocation rate of 1:1. Stata 14.0 was used. Allocated by the principal investigator (direct communication). BLINDING (MASKING): Patients not blinded. Caregivers not blinded. Participants not blinded. Statistician will not know the allocation. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 92 patients in each arm. 184 total number of patients. TRIAL STATUS: Protocol version 2.0., approved October 2, 2020. Trial ongoing. Recruitment start: June 23, 2020. Anticipate finish recruiting: November 30, 2020. The protocol has been submitted before the last patient and last visit. The delay in sending to publication is responsibility of the authors. TRIAL REGISTRATION: Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID). Registration number NCT04451174 . Date of trial registration: June 26, 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Evaluación de parámetros de banda ancha en la determinación de dominancia cerebral durante la hipnosis / Evaluation of wide band parameters in the determination of cerebral dominance during hypnosis

Se realizó un estudio cuasiexperimental de 21 estudiantes que cursaban la carrera de medicina, los cuales se encontraban en estado de hipnosis, atendidos en el Hospital General Docente Dr Juan Bruno Zayas Alfonso de Santiago de Cuba, desde septiembre del 2014 hasta junio del 2015, con vistas a identificar las medidas espectrales de banda ancha sensibles en la determinación de la dominancia cerebral durante dicho estado. Entre las variables analizadas figuraron: nivel de profundidad hipnótica, medidas espectrales de banda ancha y derivación. Se utilizó el estadígrafo false discovery rate como prueba de hipótesis para validar la información estadística y el análisis de varianza multivariado Manova. Los resultados revelaron que el poder relativo theta resultó ser la medida espectral con modificaciones más significativas y mostró un predominio discreto de la energía en el hemisferio izquierdo. Se concluyó que este hallazgo tuvo lugar como consecuencia de las tareas indicadas durante la hipnosis

A quasi-experiment of 21 students that were studying the medicine career, who were in hypnosis state, assisted in Dr Juan Bruno Zayas Alfonso Teaching General Hospital in Santiago de Cuba, was carried out from September, 2014 to June, 2015, aimed at identifying the wide band spectral measures sensitive in the determination of cerebral dominance during this state. Among the analyzed variables we can mention: level of hypnotic depth and spectral measures of wide band and derivation. The false discovery rate stadigraph was used as hypothesis test to validate the statistical information and the Manova multivaried analysis of variance. The results revealed that theta relative power was the spectral measure with more significant modifications and showed a discreet prevalence of energy in the left hemisphere. It was concluded that this finding took place as a consequence of the given tasks during hypnosis