bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of In Utero Exposure to Antiepileptic Drugs on Neonatal Brain Function
Authors: Tokariev Anton , Breakspear Michael , Videman Mari , Stjerna Susanna , Scholtens Lianne H , van den Heuvel Martijn P , Cocchi Luca , Vanhatalo Sampsa 
Published: September 2021

Abstract
In utero brain development underpins brain health across the lifespan but is vulnerable to physiological and pharmacological perturbation. Here, we show that antiepileptic medication during pregnancy impacts on cortical activity during neonatal sleep, a potent indicator of newborn brain health. These effects are evident in frequency-specific functional brain networks and carry prognostic information for later neurodevelopment. Notably, such effects differ between different antiepileptic drugs that suggest neurodevelopmental adversity from exposure to antiepileptic drugs and not maternal epilepsy per se. This work provides translatable bedside metrics of brain health that are sensitive to the effects of antiepileptic drugs on postnatal neurodevelopment and carry direct prognostic value.
Symmetry Processing in the Macaque Visual Cortex
Authors: Audurier Pauline , Héjja-Brichard Yseult , De Castro Vanessa , Kohler Peter J , Norcia Anthony M , Durand Jean-Baptiste , Cottereau Benoit R 
Published: September 2021

Abstract
Symmetry is a highly salient feature of the natural world that is perceived by many species. In humans, the cerebral areas processing symmetry are now well identified from neuroimaging measurements. Macaque could constitute a good animal model to explore the underlying neural mechanisms, but a previous comparative study concluded that functional magnetic resonance imaging responses to mirror symmetry in this species were weaker than those observed in humans. Here, we re-examined symmetry processing in macaques from a broader perspective, using both rotation and reflection symmetry embedded in regular textures. Highly consistent responses to symmetry were found in a large network of areas (notably in areas V3 and V4), in line with what was reported in humans under identical experimental conditions. Our results suggest that the cortical networks that process symmetry in humans and macaques are potentially more similar than previously reported and point toward macaque as a relevant model for understanding symmetry processing.
False Coronavirus Disease 2019 Cases due to Contamination by Inactivated Virus Vaccine
Authors: To Kelvin Kai-Wang , Li Xin , Lung David Christopher , Ip Jonathan Daniel , Chan Wan-Mui , Chu Allen Wing-Ho , Yip Cyril Chik-Yan , Chen Jonathan H K , Poon Rosana Wing-Shan , Tsoi Hoi-Wah , Lai Raymond Wai-Man , To Wing-Kin , Ren Lili , Li Mingkun , Cao Yunlong , Xie Xiaoliang Sunney , Jin Dong-Yan , Yuen Kwok-Yung 
Published: September 2021

Abstract
A false-positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse-transcription polymerase chain reaction result can lead to unnecessary public health measures. We report 2 individuals whose respiratory specimens were contaminated by an inactivated SARS-CoV-2 vaccine strain (CoronaVac), likely at vaccination premises. Incidentally, whole genome sequencing of CoronaVac showed adaptive deletions on the spike protein, which do not result in observable changes of antigenicity.
Clinical and Infection Prevention Applications of Severe Acute Respiratory Syndrome Coronavirus 2 Genotyping: An Infectious Diseases Society of America/American Society for Microbiology Consensus Review Document
Authors: Greninger Alexander L , Dien Bard Jennifer , Colgrove Robert C , Graf Erin H , Hanson Kimberly E , Hayden Mary K , Humphries Romney M , Lowe Christopher F , Miller Melissa B , Pillai Dylan R , Rhoads Daniel D , Yao Joseph D , Lee Francesca M 
Published: September 2021

Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged into a world of maturing pathogen genomics, with &gt;2 million genomes sequenced at this writing. The rise of more transmissible variants of concern that affect vaccine and therapeutic effectiveness has led to widespread interest in SARS-CoV-2 evolution. Clinicians are also eager to take advantage of the information provided by SARS-CoV-2 genotyping beyond surveillance purposes. Here, we review the potential role of SARS-CoV-2 genotyping in clinical care. The review covers clinical use cases for SARS-CoV-2 genotyping, methods of SARS-CoV-2 genotyping, assay validation and regulatory requirements, clinical reporting for laboratories, and emerging issues in clinical SARS-CoV-2 sequencing. While clinical uses of SARS-CoV-2 genotyping are currently limited, rapid technological change along with a growing ability to interpret variants in real time foretell a growing role for SARS-CoV-2 genotyping in clinical care as continuing data emerge on vaccine and therapeutic efficacy.
Building Global Capacity to Conduct Pathology-Based Postmortem Examination: Establishing a New Training Hub for Minimally Invasive Tissue Sampling
Authors: Paganelli Christina R , Parlberg Lindsay , Goco Norman J , Ritter Jana M , Martines Roosecelis B , Zaki Sherif R , Walong Edwin , Ochieng Washington , Inyangala Dennis , Barake Walter , Wachiury Cyrus , Rakislova Natalia , Marimon Lorena , Ferrando Melania , Ordi Jaume , McClure Elizabeth 
Published: September 2021

Abstract

Background
Minimally invasive tissue sampling (MITS), an alternative to complete diagnostic autopsy, is a pathology-based postmortem examination that has been validated in low- and middle-income countries (LMICs) and can provide accurate cause of death information when used with other data. The MITS Surveillance Alliance was established in 2017 with the goal to expand MITS globally by increasing training capacity, accessibility, and availability in LMICs. Between January 2019 and May 2020, the MITS Surveillance Alliance convened a multidisciplinary team of technical advisors to attain this goal.

Methods
This article describes the process used to develop criteria and identify an optimal location for a MITS training hub, establish a cadre of LMIC-based trainers, refine standardized MITS sample collection protocols, develop a training program, and release a telepathology platform for quality assessment of MITS histological samples.

Results
Results include the creation of a training hub and curriculum, with a total of 9 pathologists and technicians trained as part of the training of the trainers. Those trainers trained 15 participants from seven MITS projects representing 6 LMICs trained in MITS sample collection. The 15 participants have gone on to train more than 50 project-level staff in MITS sample collection.

Conclusions
Lessons learned include an appreciation for using an iterative process for establishing standardized procedures, creating opportunities for all stakeholders to deliver critical feedback, and highlighting the importance of complementing in-person trainings with ongoing technical assistance.
High-Resolution Genomic Profiling of Carbapenem-Resistant Klebsiella pneumoniae Isolates: A Multicentric Retrospective Indian Study
Authors: Nagaraj Geetha , Shamanna Varun , Govindan Vandana , Rose Steffimole , Sravani D , Akshata K P , Shincy M R , Venkatesha V T , Abrudan Monica , Argimón Silvia , Kekre Mihir , Underwood Anthony , Aanensen David M , Ravikumar K L ,   NIHR Global Health Research Unit on Genomic Surveillance of Antimicrobial Resistance, Abudahab Khalil , Harste Harry , Muddyman Dawn , Taylor Ben , Wheeler Nicole , David Sophia , Donado-Godoy Pilar , Bernal Johan Fabian , Arevalo Alejandra , Valencia Maria Fernanda , Osma Castro Erik C D , Ravishankar K N , Okeke Iruka N , Oaikhena Anderson O , Afolayan Ayorinde O , Ajiboye Jolaade J , Odih Erkison Ewomazino , Carlos Celia , Lagrada Marietta L , Macaranas Polle Krystle V , Olorosa Agnettah M , Gayeta June M , Herrera Elmer M 
Published: September 2021

Abstract

Background
Carbapenem-resistant Klebsiella pneumoniae (CRKP) is a threat to public health in India because of its high dissemination, mortality, and limited treatment options. Its genomic variability is reflected in the diversity of sequence types, virulence factors, and antimicrobial resistance (AMR) mechanisms. This study aims to characterize the clonal relationships and genetic mechanisms of resistance and virulence in CRKP isolates in India.

Materials and Methods
We characterized 344 retrospective K. pneumoniae clinical isolates collected from 8 centers across India collected in 2013–2019. Susceptibility to antibiotics was tested with VITEK 2. Capsular types, multilocus sequence type, virulence genes, AMR determinants, plasmid replicon types, and a single-nucleotide polymorphism phylogeny were inferred from their whole genome sequences.

Results
Phylogenetic analysis of the 325 Klebsiella isolates that passed quality control revealed 3 groups: K. pneumoniae sensu stricto (n = 307), K. quasipneumoniae (n = 17), and K. variicola (n = 1). Sequencing and capsular diversity analysis of the 307 K. pneumoniae sensu stricto isolates revealed 28 sequence types, 26 K-locus types, and 11 O-locus types, with ST231, KL51, and O1V2 being predominant. blaOXA-48-like and blaNDM-1/5 were present in 73.2% and 24.4% of isolates, respectively. The major plasmid replicon types associated with carbapenase genes were IncF (51.0%) and Col group (35.0%).

Conclusion
Our study documents for the first time the genetic diversity of K and O antigens circulating in India. The results demonstrate the practical applicability of genomic surveillance and its utility in tracking the population dynamics of CRKP. It alerts us to the urgency for longitudinal surveillance of these transmissible lineages.
Good Financial Grant Practice: A Tool for Developing and Demonstrating Institutional Financial and Grant Management Capacity in Global Health
Authors: Harste Harry J , Kiff Genevieve , Okeke Iruka N , Adebiyi Akindele O , Ravikumar K L , Nagaraj Geetha , Ajiboye Jolaade J , Osma Castro Erik C D , Herrera Elmer , Aanensen David M ,   NIHR Global Health Research Unit on Genomic Surveillance of Antimicrobial Resistance, Abudahab Khalil , Abrudan Monica , Argimón Silvia , Kekre Mihir , Muddyman Dawn , Taylor Ben , Underwood Anthony , Wheeler Nicole , Sophia David , Donado-Godoy Pilar , Fabian Bernal Johan , Arevalo Alejandra , Fernanda Valencia Maria , Shamanna Varun , Govindan Vandana , Prabhu Akshata , Sravani D , Shincy M R , Rose Steffimole , Ravishankar K N , Oaikhena Anderson O , Afolayan Ayorinde O , Ewomazino Odih Erkison , Carlos Celia , Lagrada Marietta L , Macaranas Polle Krystle V , Olorosa Agnettah M , Gayeta June M 
Published: September 2021

AbstractThe administration and governance of grant funding across global health organizations presents enormous challenges. Meeting these challenges is crucial to ensuring that funds are used in the most effective way to improve health outcomes, in line with the United Nations’ Sustainable Development Goal 3, “Ensure healthy lives and promote well-being for all at all ages.” The Good Financial Grant Practice (GFGP) Standard (ARS 1651) is the world’s first and, currently, only international standard for the financial governance and management of grant funding. Through consensus building and global harmonization between both low- and middle-income and high-income country players, the GFGP Standard has achieved a leveling impact: GFGP applies equally to, and can be implemented by, all types of organization, regardless of location, size, or whether they predominantly give or receive funding.GFGP can be used as a tool for addressing some of the challenges of the current funding model. Here, we describe our experiences and lessons learned from implementing GFGP across 4 diverse research institutions in India, Nigeria, Colombia, and the Philippines as part of our National Institute for Health Research Global Health Research Unit on Genomic Surveillance of Antimicrobial Resistance.
Enteric Illness Outbreaks Reported Through the National Outbreak Reporting System—United States, 2009–2019
Authors: Wikswo Mary E , Roberts Virginia , Marsh Zachary , Manikonda Karunya , Gleason Brigette , Kambhampati Anita , Mattison Claire , Calderwood Laura , Balachandran Neha , Cardemil Cristina , Hall Aron J 
Published: September 2021

Abstract

Background
The National Outbreak Reporting System (NORS) captures data on foodborne, waterborne, and enteric illness outbreaks in the United States. This study describes enteric illness outbreaks reported during 11 years of surveillance.

Methods
We extracted finalized reports from NORS for outbreaks occurring during 2009–2019. Outbreaks were included if caused by an enteric etiology or if any patients reported diarrhea, vomiting, bloody stools, or unspecified acute gastroenteritis.

Results
A total of 38 395 outbreaks met inclusion criteria, increasing from 1932 in 2009 to 3889 in 2019. Outbreaks were most commonly transmitted through person-to-person contact (n = 23 812; 62%) and contaminated food (n = 9234; 24%). Norovirus was the most commonly reported etiology, reported in 22 820 (59%) outbreaks, followed by Salmonella (n = 2449; 6%) and Shigella (n = 1171; 3%). Norovirus outbreaks were significantly larger, with a median of 22 illnesses per outbreak, than outbreaks caused by the other most common outbreak etiologies (P &lt; .0001, all comparisons). Hospitalization rates were higher in outbreaks caused by Salmonella and Escherichia coli outbreaks (20.9% and 22.8%, respectively) than those caused by norovirus (2%). Case fatality rate was highest in E. coli outbreaks (0.5%) and lowest in Shigella and Campylobacter outbreaks (0.02%).

Conclusions
Norovirus caused the most outbreaks and outbreak-associated illness, hospitalizations, and deaths. However, persons in E. coli and Salmonella outbreaks were more likely to be hospitalized or die. Outbreak surveillance through NORS provides the relative contributions of each mode of transmission and etiology for reported enteric illness outbreaks, which can guide targeted interventions.
A Quest for Due Process Doctrine in Vietnamese Law: From Soviet Legacy to Global Constitutionalism
Authors: Bui Dat T 
Published: September 2021

Abstract
Due process—the ‘soul’ of a modern constitution—was not seriously taken into account under purely socialist legal systems in general as well as in pre-2013 Vietnamese constitutions in particular. Since the 2013 Constitution, Vietnamese jurisprudence has incorporated the human rights-limitation principle (substantive due process) for the first time and strengthened the application of universal fair trial rights (procedural due process). This constitutional development is the result of the fact that, over the past two decades, the class-based perception of human rights has been increasingly less important and has been almost replaced by universalism. This article claims that, because of the influence of Soviet jurisprudence, the Vietnamese version of due process has been characterized by the fact that human rights could be arbitrarily trumped by public interests and that fair trial rights have been problematically limited to criminal proceedings and almost ignored in non-criminal procedures. This article analyses the importance of, and the challenges involved in, incorporating the human rights-limitation principle into the 2013 Constitution and argues for an extension of fair trial rights to all kinds of criminal, civil, administrative, and mixed procedures in keeping with global constitutionalism.
The effect of health shocks on labour market outcomes in Russia
Authors: Aleksandrova Ekaterina , Bagranova Venera , Gerry Christopher J 
Published: September 2021

Abstract
This study examines the effects of individual health shocks on labour market outcomes in the Russian Federation during the period 2000–2018. Employing data from the Russia Longitudinal Monitoring Survey—Higher School of Economics, we demonstrate that adverse health shocks have negative consequences for employment, wages, and income. We find that the effects are strongest for males, the less educated, those on lower incomes, those in middle-ranking and professional occupations, and for those experiencing the most severe health shocks. However, consistent with our knowledge of the Russian labour market, we also observe that the wage and income elasticities are considerably higher than the employment elasticities and above those reported for other countries. Understanding how to attenuate the negative labour market consequences associated with health shocks is paramount and we, therefore, consider the potential role that labour, health and social policies can play in mitigating risk.
Artificial Intelligence and Mapping a New Direction in Laboratory Medicine: A Review
Authors: Herman Daniel S , Rhoads Daniel D , Schulz Wade L , Durant Thomas J S 
Published: September 2021

AbstractBackgroundModern artificial intelligence (AI) and machine learning (ML) methods are now capable of completing tasks with performance characteristics that are comparable to those of expert human operators. As a result, many areas throughout healthcare are incorporating these technologies, including in vitro diagnostics and, more broadly, laboratory medicine. However, there are limited literature reviews of the landscape, likely future, and challenges of the application of AI/ML in laboratory medicine.ContentIn this review, we begin with a brief introduction to AI and its subfield of ML. The ensuing sections describe ML systems that are currently in clinical laboratory practice or are being proposed for such use in recent literature, ML systems that use laboratory data outside the clinical laboratory, challenges to the adoption of ML, and future opportunities for ML in laboratory medicine.SummaryAI and ML have and will continue to influence the practice and scope of laboratory medicine dramatically. This has been made possible by advancements in modern computing and the widespread digitization of health information. These technologies are being rapidly developed and described, but in comparison, their implementation thus far has been modest. To spur the implementation of reliable and sophisticated ML-based technologies, we need to establish best practices further and improve our information system and communication infrastructure. The participation of the clinical laboratory community is essential to ensure that laboratory data are sufficiently available and incorporated conscientiously into robust, safe, and clinically effective ML-supported clinical diagnostics.
Optimizing Available Tools for Achieving Result Standardization: Value Added by Joint Committee on Traceability in Laboratory Medicine (JCTLM)
Authors: Panteghini Mauro , Braga Federica , Camara Johanna E , Delatour Vincent , Van Uytfanghe Katleen , Vesper Hubert W , Zhang Tianjiao ,   for the JCTLM Task Force on Reference Measurement System Implementation
Published: September 2021

Abstract

Background
The JCTLM created a Task Force on Reference Measurement System Implementation (TF-RMSI) to provide guidance on metrological traceability implementation for the in vitro diagnostics (IVD) community.

Content
TF-RMSI investigated the reference measurement systems (RMS) for 13 common measurands by applying the following procedural steps: (a) extracting data from the JCTLM database of available certified reference materials (CRMs) and reference measurement procedures (RMPs); (b) describing the RMS to which each recruited CRM or RMP belongs; (c) identifying the intended use of the CRMs, and, if used as a common calibrator for IVD measuring systems and/or trueness assessment of field methods was included, checking the CRM’s certificate for information about commutability with clinical samples; and (d) checking if the CRM or RMP measurement uncertainty (MU) has the potential to be small enough to avoid significantly affecting the analytical performance specifications (APS) for MU of clinical sample results when the MU from the IVD calibrator and from the end-user measuring system were combined.

Summary
We produced a synopsis of JCTLM-listed higher-order CRMs and RMPs for the selected measurands, including their main characteristics for implementing traceability and fulfilling (or not) the APS for suitable MU. Results showed that traceability to higher-order references can be established by IVD manufacturers within the defined APS for most of the 13 selected measurands. However, some measurands do not yet have suitable CRMs for use as common calibrators. For these measurands, splitting clinical samples with a laboratory performing the RMP may provide a practical alternative for establishing a calibration hierarchy.
Multiple Myeloma Minimal Residual Disease Detection: Targeted Mass Spectrometry in Blood vs Next-Generation Sequencing in Bone Marrow
Authors: Langerhorst Pieter , Noori Somayya , Zajec Marina , De Rijke Yolanda B , Gloerich Jolein , van Gool Alain J , Caillon Hélène , Joosten Irma , Luider Theo M , Corre Jill , VanDuijn Martijn M , Dejoie Thomas , Jacobs Joannes F M 
Published: September 2021

AbstractBackgroundMinimal residual disease (MRD) status assessed on bone marrow aspirates is a major prognostic biomarker in multiple myeloma (MM). In this study we evaluated blood-based targeted mass spectrometry (MS-MRD) as a sensitive, minimally invasive alternative to measure MM disease activity.MethodsTherapy response of 41 MM patients in the IFM-2009 clinical trial (NCT01191060) was assessed with MS-MRD on frozen sera and compared to routine state-of-the-art monoclonal protein (M-protein) diagnostics and next-generation sequencing (NGS-MRD) at 2 time points.ResultsIn all 41 patients we were able to identify clonotypic M-protein-specific peptides and perform serum-based MS-MRD measurements. MS-MRD is significantly more sensitive to detect M-protein compared to either electrophoretic M-protein diagnostics or serum free light chain analysis. The concordance between NGS-MRD and MS-MRD status in 81 paired bone marrow/sera samples was 79%. The 50% progression-free survival (PFS) was identical (49 months) for patients who were either NGS-positive or MS-positive directly after maintenance treatment. The 50% PFS was 69 and 89 months for NGS-negative and MS-negative patients, respectively. The longest 50% PFS (96 months) was observed in patients who were MRD-negative for both methods. MS-MRD relapse during maintenance treatment was significantly correlated to poor PFS (P &lt; 0.0001).ConclusionsOur data indicate proof-of-principle that MS-MRD evaluation in blood is a feasible, patient friendly alternative to NGS-MRD assessed on bone marrow. Clinical validation of the prognostic value of MS-MRD and its complementary value in MRD-evaluation of patients with MM is warranted in an independent larger cohort.