Writing Committee for the REMAP-CAP Investigators IMPORTANCE The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.OBJECTIVE To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTSThe ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONSThe immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURESThe primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, −1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. RESULTS Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11...
Background:The anticariogenic potential of casein phosphopeptide-amorphous calcium phosphate nanocomplexes (CPP-ACP) has been demonstrated using laboratory, animal and human in situ caries models. The aim of this study was to determine the effect of CPP-ACP incorporation into a sugar-free lozenge (pressed mint tablet) on enamel remineralization in a human in situ model. Methods:The study utilized a double-blind, randomized, cross-over design with four treatments: (i) a lozenge containing 56.4mg (3 per cent w/w) CPP-ACP; (ii) a lozenge containing 18.8mg (1 per cent w/w) CPP-ACP; (iii) a lozenge not containing CPP-ACP; and (iv) a no lozenge nil-treatment control. Ten subjects wore removable palatal appliances with four, human-enamel, half-slab insets containing subsurface lesions. Lozenges were consumed, without chewing, four times per day for 14 days duration. After each treatment period the enamel slabs were removed, paired with their respective demineralized control, embedded, sectioned and subjected to microradiography and computer-assisted densitometric image analysis to determine the level of remineralization. Results: The incorporation of CPP-ACP into the lozenge significantly increased enamel subsurface lesion remineralization with 18.8 and 56.4mg of CPP-ACP increasing remineralization by 78 and 176 per cent respectively, relative to the control sugarfree lozenge. Conclusion: This study demonstrates that lozenges are a suitable vehicle for the delivery of CPP-ACP to promote enamel remineralization.
Background: The consumption of acidic foods and drinks is increasing in popularity. The purposes of the present study were to investigate the consumption patterns of acidic foods and drinks among several sport groups and to examine any relationships between consumption patterns and dental erosion. Methods: A questionnaire of oral health habits, diet and dental health was developed. Thirty-two sports clubs (690 members) of the University of Melbourne participated in a survey. A total of 508 usable questionnaires were received (74.9 per cent response). Descriptive statistics were prepared and logistic regression was used to explore relationships between dental erosion (dependent variable) and the independent variables.
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