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International workshop: what is needed to ensure outcome measures for Rett syndrome are fit-for-purpose for clinical trials? June 7, 2023, Nashville, USAThe clinical, research and advocacy communities for Rett syndrome are striving to achieve clinical trial readiness, including having fit-for-purpose clinical outcome assessments. This study aimed to (1) describe psychometric properties of clinical outcome assessment for Rett syndrome and (2) identify what is needed to ensure that fit-for-purpose clinical outcome assessments are available for clinical trials.
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Delay in commencement of palliative care service episodes provided to Indigenous and non-Indigenous patientsAlthough the timeliness benchmark is being met for Indigenous Australians in palliative care, they may experience delayed initiation of care episodes
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The Western Environment Reduces Innate Immune Cytokine Production in Chinese ImmigrantsWe recruited age- and sex-matched Chinese immigrants living in Western Australia for less than 6 months (newly arrived, n = 22) or more than 5 years.
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Severe winter asthma exacerbations can be prevented by omalizumab, but there is no carryover effect.Recurrent severe asthma exacerbations are associated with decreased lung growth or accelerated loss of long function and add substantially to cost and morbidity
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Safety and efficacy of the predictive low glucose management system in the prevention of hypoglycaemiaThe predictive low glucose management system was evaluated in in-clinic studies, and has informed a larger home trial to study its efficacy and safety
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Diet at birth is critical for healthy growth, independent of effects on the gut microbiotaColostrum is the first milk for a newborn. Its high content in microbiota shaping compounds and its intake at the time of gut microbiota seeding suggests colostrum may be critical in the establishment of a healthy microbiota. There is also accumulating evidence on the importance of the gut microbiota for healthy growth.
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Antibody and cell-mediated immunity to pertussis 4 years after monovalent acellular pertussis vaccine at birthIn the longest reported follow-up of infants who received aP vaccine at birth, we found a trend to lower PT IgG antibodies post booster compared with receipt...
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Birth cohorts in asthma and allergic diseases: Report of a NIAID/NHLBI/MeDALL joint workshopPopulation-based birth cohorts on asthma and allergies increasingly provide new insights into the development and natural history of the diseases.
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Study protocol for controlled human infection for penicillin G against Streptococcus pyogenes: a double-blinded, placebo-controlled, randomised trial to determine the minimum concentration required to prevent experimental pharyngitis (the CHIPS trial)Regular intramuscular benzathine penicillin G injections have been the cornerstone of rheumatic heart disease (RHD) secondary prophylaxis since the 1950s. As the pharmacological correlate of protection remains unknown, it is difficult to recommend changes to this established regimen. Determining the minimum effective penicillin exposure required to prevent Streptococcus pyogenes infection will accelerate development of new long-acting penicillins for RHD prevention as well as inform opportunities to improve existing regimens. The CHIPS trial will address this knowledge gap by directly testing protection afforded by different steady state plasma concentrations of penicillin in an established model of experimental human S. pyogenes pharyngitis.
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Applying causal inference and Bayesian statistics to understanding vaccine safety signals using a simulation studyCommunity perception of vaccine safety influences vaccine uptake. Our objective was to assess current vaccine safety monitoring by examining factors that may influence the availability of post-vaccination survey data, and thereby the specificity and sensitivity of existing signal detection methods.