Reformation of a Clinical Anti-Drug Antibody Assay to Enable the Immunogenicity Assessment of a Bispecific Antibody Biotherapeutic.

An enzyme-linked immunosorbent assay (ELISA) based anti-drug antibody (ADA) assay was developed to support the clinical development of a bispecific antibody biotherapeutic anti-A/B. This anti-A/B clinical ADA Version 1 (V1) assay was successfully validated initially using commercial samples from the target indication. However, applying the validation cut point factors (CPFs) led to a high untreated ADA positive rate in the Phase 1 study baseline sample analysis.

Use of Artificial Intelligence in Cobb Angle Measurement for Scoliosis: Retrospective Reliability and Accuracy Study of a Mobile App.

Background: Scoliosis is a spinal deformity in which one or more spinal segments bend to the side or show vertebral rotation. Some artificial intelligence (AI) apps have already been developed for measuring the Cobb angle in patients with scoliosis. These apps still require doctors to perform certain measurements, which can lead to interobserver variability.

Reactivity of -(isocyanoimino)triphenylphosphorane toward group 13 Lewis acids.

The species PhPNNC 1 reacts with the group 13 Lewis acids E(CF) (E = B or Al), HB(CF), ClAl(CF) and ECl (E = Ga or In) to give the Lewis acid-base adduct PhPNNCB(CF) 2, the zwitterionic product (PhPNH)B(CF)CNB(CF)H 3, the chelated salts [(PhPNNC(CN)NPPh)ER][EXR] (E = Al, R = X = CF, 4; E = Al, R = CF, X = Cl, 5; E = Ga, R = X = Cl, 6), and the neutral species [(PhPNNC(CN)NPPh)InCl] 7. The nature of these variations in reactivity are rationalized and the potential utility considered.

Incidence and outcome of biliary atresia in Shanghai, China from 2015 to 2016: a cohort study.

Demographic characteristics and clinical data of all newly diagnosed biliary atresia patients in Shanghai were collected from 1 January 2015 to 31 October 2016. The total number of live births was 377 420 during the study period, and the incidence of biliary atresia in Shanghai was 10.86 per 100 000 (95% CI 7.

Changes in skin barrier over the first four days of life: a cross-sectional study.

Background: We aimed to evaluate the trajectory of skin barrier properties in full-term newborns during the first four days after birth.

Methods: Based on the MKNFOAD cohort (NCT02889081), transepidermal water loss (TEWL), stratum corneum hydration (SCH), skin pH, and sebum content at five anatomical sites (cheek, forehead, volar forearm, abdomen, and dorsal lower leg) were examined once within 96 h after birth in 384 full-term infants. Multivariable linear regression analysis was performed to assess variations in these skin barrier parameters with age adjusted for gestational age, neonate's sex, parents' allergy history, delivery mode, amniotic fluid characteristics, and birth weight.

Dietary folic acid intake, 13 genetic variants and other factors with red blood cell folate concentration in pregnancy-preparing population.

Purpose: This study aims to evaluate a combined effect of dietary folic acid intake, multiple genetic polymorphisms in folate metabolism, and other environmental factors on red blood cell (RBC) folate concentration in pregnancy-preparing population.

Methods: 519 pregnancy-preparing subjects (260 couples) were investigated. Dietary intake was measured by 3-day dietary recalls.

Serum matrix metalloproteinase-7 for discriminating biliary atresia: a diagnostic accuracy and validation study.

Background: Prompt and precise differential diagnosis of biliary atresia (BA) among cholestatic patients is of great importance. Matrix metalloproteinase-7 (MMP-7) holds great promise as a diagnostic marker for BA. This study aimed to investigate the accuracy of age-specific serum MMP-7 for discriminating BA from other cholestatic pediatric patients.

Association of copy number variation in X chromosome-linked PNPLA4 with heterotaxy and congenital heart disease.

Background: Heterotaxy (HTX) is a thoracoabdominal organ anomaly syndrome and commonly accompanied by congenital heart disease (CHD). The aim of this study was to analyze rare copy number variations (CNVs) in a HTX/CHD cohort and to examine the potential mechanisms contributing to HTX/CHD.

Methods: Chromosome microarray analysis was used to identify rare CNVs in a cohort of 120 unrelated HTX/CHD patients, and available samples from parents were used to confirm the inheritance pattern.

Diagnostic Value of Tc-MIBI Myocardial Perfusion Imaging in Detecting Myocardial Ischemia of Children with Kawasaki Disease and Coronary Artery Lesions.

Pediatric patients with coronary artery lesions (CALs) after Kawasaki disease (KD) may be complicated with myocardial ischemia. Although previous studies in adults have proven the diagnostic value of Tc-MIBI myocardial perfusion imaging (MPI) for ischemic heart disease, its feasibility and accuracy in this pediatric population remain uncertain. In this retrospective study, we collected data of 177 pediatric patients (Age range: 6 months to 14 years) who had undergone MPI and coronary artery angiography (CAG) between July 2019 and February 2023.

Managing Super Pests: Interplay between Pathogens and Symbionts Informs Biocontrol of Whiteflies.

is distributed globally and incurs considerable economic and ecological costs as an agricultural pest and viral vector. The entomopathogenic fungus has been known for its insecticidal activity, but its impacts on whiteflies are understudied. We investigated how infection with the semi-persistently transmitted Cucurbit chlorotic yellows virus (CCYV) affects whitefly susceptibility to exposure.

Temporal trend in mortality due to congenital heart disease in China from 2008 to 2021.

Background: Congenital heart disease (CHD) is a leading cause of birth defect-related mortality. However, more recent CHD mortality data for China are lacking. Additionally, limited studies have evaluated sex, rural-urban, and region-specific disparities of CHD mortality in China.

Pathogen-specific alterations in intestinal microbiota precede urinary tract infections in preterm infants: a longitudinal case-control study.

Urinary tract infections (UTIs) are among the most common late-onset infections in preterm infants, characterized by nonspecific symptoms and a pathogenic spectrum that diverges from that of term infants and older children, which present unique diagnostic and therapeutic challenges. Existing data on the role of gut microbiota in UTI pathogenesis in this demographic are limited. This study aims to investigate alterations in gut microbiota and fecal calprotectin levels and their association with the development of UTIs in hospitalized preterm infants.

Associations of Early Gut Microbiome and Metabolome with Growth and Body Composition of Preterm Infants Within the First 6 Months.

This study aimed to explore the associations of growth and body composition with gut microbiome and metabolome in preterm infants. A prospective cohort study including 73 human milk-fed very preterm infants was conducted. During hospitalization, fecal samples were collected to detect microbes and metabolites using 16S rRNA gene sequencing and liquid chromatography-mass spectrometry.

Clinical implications of respiratory ciliary dysfunction in heterotaxy patients with congenital heart disease: elevated risk of postoperative airway complications.

Objective: Cardiac surgery in Congenital Heart Disease-Heterotaxy (CHD-HTX) patients often leads to increased postoperative airway complications. Abnormal respiratory ciliary function, resembling primary ciliary dyskinesia, has been observed. We expanded the sample size by retrospectively reviewing Ciliary Dysfunction (CD) in CHD-HTX patients to verify the increased risk of post-surgical respiratory complications.

Using a new human milk fortifier to optimize human milk feeding among very preterm and/or very low birth weight infants: a multicenter study in China.

Background: Human milk fortifier (HMF) composition has been optimized recently. But clinical evidence of its safety and efficacy is limited in Chinese population. The aim of this study was to evaluate effects of a new HMF in growth, nutritional status, feeding intolerance, and major morbidities among very preterm (VPT) or very low birth weight (VLBW) infants in China.

Association Between Serum Glycated Hemoglobin Levels at Early Gestation and the Risk of Subsequent Pregnancy Loss in Pregnant Women Without Diabetes Mellitus: Prospective Cohort Study.

Background: As a severe morbidity during pregnancy, the etiology of spontaneous pregnancy loss (SPL) remains largely unknown. Serum glycated hemoglobin (HbA) level is an established predictor of SPL risk among women with diabetes, but little is known about whether such an association exists among pregnant women without diabetes when glycemic levels are within the normal range.

Objective: This study aimed to quantify the association between maternal HbA levels in early pregnancy and subsequent SPL risk in a cohort of pregnant women without diabetes.

Trajectory of stratum corneum lipid subclasses in the first year of life and associations with atopic dermatitis: A prospective cohort study.

Background: Trajectories of stratum corneum (SC) lipid subclasses and their associations with infant atopic dermatitis (AD) are unclear. This study aimed to quantify the trajectories of 15 SC subclasses and carbon chain lengths and their associations with AD within 12 months.

Methods: In total, 213 newborns were enrolled at birth with nonlesional skin samples collected from the inner forearm at birth, 42 days, 3, 6, and 12 months, respectively.

Dynamics and Crosstalk between Gut Microbiota, Metabolome, and Fecal Calprotectin in Very Preterm Infants: Insights into Feeding Intolerance.

Background: Feeding intolerance (FI) is a significant concern in the care of preterm infants, impacting their growth and development. We previously reported that FI is linked to lower fecal calprotectin (FC) levels. This study aims to explore the postnatal dynamics and interplay between microbiota, metabolic profiles, and host immunity in preterm infants with and without FI.