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Edaravone for the Treatment of Motor Neurone Disease: A Critical Review of Approved and Alternative Formulations against a Proposed Quality Target Product ProfileEdaravone is one of two main drugs for treating motor neurone disease (MND). This review proposes a specific quality target product profile (QTPP) for edaravone following an appraisal of the issues accounting for the poor clinical uptake of the approved IV and oral liquid edaravone formulations. This is followed by a review of the alternative oral formulations of edaravone described in the published patent and journal literature against the QTPP.
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Effects of a live versus heat-inactivated probiotic Bifidobacterium spp in preterm infants: a randomised clinical trialHeat-inactivated probiotics (HPs) may provide an effective alternative to live probiotics by avoiding their risks (eg, probiotic sepsis) while retaining the benefits. We assessed the safety and efficacy of a HP in very preterm (VP: gestation <32 weeks) infants.
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Plasma testosterone concentration is correlated with circulating immune cell abundance in transgender young people on gender-affirming hormone treatmentSex hormones, such as oestrogen and testosterone, display significant immune modulatory properties. This is highly relevant for transgender (trans) people who undergo gender-affirming hormone (GAH) treatment. However, only a limited number of studies have evaluated the immunological impact of GAH treatments, and almost none have assessed the impact in trans young people.
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Cardiac monitoring safety assessment framework for early phase group a streptococcal vaccine trialsThis paper presents a comprehensive cardiac safety framework for early clinical development of Streptococcus pyogenes (Group A Streptococcus) vaccines, endorsed by the Strep A Vaccine Global Consortium and the Australian Strep A Vaccine Initiative. Given historical concerns about vaccine-associated acute rheumatic fever, we have established standardized echocardiography protocols integrated with clinical assessment for monitoring cardiac safety in early-phase vaccine trials.
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Pre-service teachers’ experiences with students impacted by trauma in the school settingExperiencing trauma may adversely impact a child’s education, and research in this field requires a deeper understanding about how those working in the education system, specifically pre-service teachers, can respond and support children impacted by trauma. Pre-service teachers, who are our future teachers, play a role in recognising and helping children when signs of trauma are revealed, but risk re-traumatising children if not adequately trained during their university education.
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Imaging of Abdominal Complications in Children With Acute Lymphoblastic LeukaemiaAcute lymphoblastic leukaemia (ALL) is the most common paediatric malignancy and remains one of the most common causes of cancer-related death in children and adolescents. Five-year overall survival rates now exceed 90% with current multidrug chemotherapeutic regimens.
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Awake Supraglottic Airway Placement in Pediatric Patients for Airway Obstruction or Difficult Intubation: Insights From an International Airway Registry (PeDI)Small case series have described awake supraglottic airway placement in infants with significant airway obstruction and difficult intubations. We conducted this study to determine outcomes when supraglottic airways were placed in awake children enrolled in the international Pediatric Difficult Intubation Registry including success of ventilation, success of tracheal intubation, and complications.
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The Vsr-like protein FASTKD4 regulates the stability and polyadenylation of the MT-ND3 mRNAExpression of the compact mitochondrial genome is regulated by nuclear encoded, mitochondrially localized RNA-binding proteins (RBPs). RBPs regulate the lifecycles of mitochondrial RNAs from transcription to degradation by mediating RNA processing, maturation, stability and translation. The Fas-activated serine/threonine kinase (FASTK) family of RBPs has been shown to regulate and fine-tune discrete aspects of mitochondrial gene expression.
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Mental health assessment of transgender youth - Should standardised psychological measures be scored by norms of birth-registered sex?Standardised psychometric measures are used in mental health care and research settings to identify risk, assist diagnosis, and assess symptom severity. Standardised scoring of these measures involves transforming respondents' raw scores using binary sex norms. However, scoring manuals offer no guidance as to appropriate scoring methods for trans and non-binary respondents.
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Malaria in Nepal: A Spatiotemporal Study of the Disease Distribution and Challenges on the Path to EliminationMalaria incidence (MI) has significantly declined in Nepal, and this study aimed to investigate the spatiotemporal distribution and drivers of MI at the ward level. Data for malaria cases were obtained from the National Surveillance System from 2013 to 2021. Data for covariates, including annual mean temperature, annual mean precipitation, and distance to the nearest city, were obtained from publicly available sources. A Bayesian spatial model was used to identify factors associated with the spatial distribution of MI.