bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pharmacokinetics and safety of liposomal bupivacaine after local infiltration in healthy Chinese adults: a phase 1 study
Authors: Cheung Bernard MY , Ng Pauline Yeung , Liu Ying , Zhou Manman , Yu Vincent , Yang Julia , Wang Natalie Q. 
Published: July 2021

Abstract
Background
Liposomal bupivacaine (LB) is a long-acting formulation of bupivacaine. The safety and efficacy of LB has been demonstrated across surgical procedures. However, pharmacokinetic (PK) parameters and safety of LB in the Chinese population have not been assessed.

Methods
In this single-arm, single center, phase 1, open-label study, PK and safety of local infiltration with LB 266 mg were assessed in healthy Chinese adults. Eligible participants were aged 18 to 55 years with biologic parents and grandparents of Chinese ethnicity, in generally good health (i.e., no clinically significant abnormalities), and with a body mass index (BMI) 19.0 to 24.0 kg/m2 (inclusive) and body weight ≥ 50 kg.

Results
Participants (N = 20) were predominantly men (80 %); mean age was 32 years; and mean BMI was 21.8 kg/m2. After LB administration, mean plasma levels of bupivacaine rapidly increased during the first hour and continued to increase through 24 h; plasma levels then gradually decreased through 108 h followed by a monoexponential decrease through 312 h. Geometric mean maximum plasma concentration was 170.9 ng/mL; the highest plasma bupivacaine concentration detected in any participant was 374.0 ng/mL. Twenty-two treatment-emergent adverse events were reported (mild, n = 21; moderate, n = 1).

Conclusions
After single-dose administration of LB, PK measures were similar to a previously reported profile in US adults. The highest observed peak plasma concentration of bupivacaine was several-fold below the plasma concentration threshold accepted as being associated with neurotoxicity or cardiotoxicity (2000–4000 ng/mL). These data support that LB is well tolerated and safe in individuals of Chinese descent.

Trial registration
NCT04158102 (ClinicalTrials.gov identifier), Date of registration: November 5, 2019.
Evaluating the performance characteristics of different antimicrobial susceptibility testing methodologies for testing susceptibility of gram-negative bacteria to tigecycline
Authors: Babaei Sima , Haeili Mehri 
Published: July 2021

Abstract
Background
The current emergence of multi-drug resistance among nosocomial pathogens has led to increased use of last-resort agents including Tigecycline (TGC). Availability of reliable methods for testing TGC susceptibility is crucial to accurately predict clinical outcomes. We evaluated the influence of different methodologies and type of media on TGC susceptibility of different gram-negative bacteria of clinical origin.

Methods
The TGC susceptibility of 84 clinical isolates of Klebsiella pneumoniae (n = 29), Escherichia coli (n = 30), and Acinetobacter baumannii (n = 25) was tested by broth microdilution (BMD), Etest, agar dilution (AD) and disk diffusion (DD) methods using Mueller Hinton agar from Difco and Mueller Hinton broth (MHB) from two different manufacturers (Difco and Condalab). FDA TGC susceptibility breakpoints issued for Enterobacteriaceae were used for interpretation of the results.

Results
MICs determined by BMD using MHB from two suppliers showed a good correlation with overall essential agreement (EA) and categorical agreement (CA) being 100% and 95% respectively. However, a twofold rise in BMD-Condalab MICs which was detected in 50% of the isolates, resulted in changes in susceptibility categories of few isolates with MICs close to susceptibility breakpoints leading to an overall minor error (MI) rate of 4.7%. Among the tested methods, Etest showed the best correlation with BMD, being characterized with the lowest error rates (only 1% MI) and highest overall EA (100%) and CA (98.8%) for all subsets of isolates. AD yielded the lowest overall agreement (EA 77%, CA 81%) with BMD in a species dependent manner, with the highest apparent discordance being found among the A. baumannii isolates. While the performance of DD for determination of TGC susceptibility among Enterobacteriaceae was excellent, (CA:100% with no errors), the CA was lower (84%) when it was used for A. baumannii where an unacceptably high minor-error rate was noted (16%). No major error or very major error was detected for any of the tested methods.

Conclusions
Etest can be reliably used for TGC susceptibility testing in the three groups of studied bacteria. For the isolates with close-to-breakpoint MICs, testing susceptibility using the reference method is recommended.
COVID-19 false dichotomies and a comprehensive review of the evidence regarding public health, COVID-19 symptomatology, SARS-CoV-2 transmission, mask wearing, and reinfection
Authors: Escandón Kevin , Rasmussen Angela L. , Bogoch Isaac I. , Murray Eleanor J. , Escandón Karina , Popescu Saskia V. , Kindrachuk Jason 
Published: July 2021

AbstractScientists across disciplines, policymakers, and journalists have voiced frustration at the unprecedented polarization and misinformation around coronavirus disease 2019 (COVID-19) pandemic. Several false dichotomies have been used to polarize debates while oversimplifying complex issues. In this comprehensive narrative review, we deconstruct six common COVID-19 false dichotomies, address the evidence on these topics, identify insights relevant to effective pandemic responses, and highlight knowledge gaps and uncertainties. The topics of this review are: 1) Health and lives vs. economy and livelihoods, 2) Indefinite lockdown vs. unlimited reopening, 3) Symptomatic vs. asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, 4) Droplet vs. aerosol transmission of SARS-CoV-2, 5) Masks for all vs. no masking, and 6) SARS-CoV-2 reinfection vs. no reinfection. We discuss the importance of multidisciplinary integration (health, social, and physical sciences), multilayered approaches to reducing risk (“Emmentaler cheese model”), harm reduction, smart masking, relaxation of interventions, and context-sensitive policymaking for COVID-19 response plans. We also address the challenges in understanding the broad clinical presentation of COVID-19, SARS-CoV-2 transmission, and SARS-CoV-2 reinfection. These key issues of science and public health policy have been presented as false dichotomies during the pandemic. However, they are hardly binary, simple, or uniform, and therefore should not be framed as polar extremes. We urge a nuanced understanding of the science and caution against black-or-white messaging, all-or-nothing guidance, and one-size-fits-all approaches. There is a need for meaningful public health communication and science-informed policies that recognize shades of gray, uncertainties, local context, and social determinants of health.
A multicentre interventional study to assess blood-borne viral infections in Belgian prisons
Authors: Busschots Dana , Kremer Cécile , Bielen Rob , Koc Özgür M. , Heyens Leen , Brixko Christian , Laukens Pierre , Orlent Hans , Bilaey Pascal , De Smet Francis , Hellemans Geert , Muyldermans Gaetan , Van Baelen Luk , Hens Niel , Van Vlierberghe Hans , Robaeys Geert 
Published: July 2021

Abstract
Background
Prevalence data on viral hepatitis B (HBV), hepatitis C (HCV), and HIV infection in prison are often scarce or outdated. There is currently no systematic screening for these blood-borne viral infections (BBV) in Belgian prisons. There is an urgency to assess the prevalence of these BBV to inform policymakers and public healthcare.

Methods
This was a multicentre, interventional study to assess the prevalence of BBV using opt-in screening in prisons across Belgium, April 2019 – March 2020. Prisoners were tested using a finger prick and BBV risk factors were assessed using a questionnaire. A generalized linear mixed model was used to investigate the association between the various risk factors and HCV.

Results
In total, 886 prisoners from 11 Belgian prisons were screened. Study uptake ranged from 16.9 to 35.4% in long-term facilities. The prevalence of HCV antibodies (Ab), hepatitis B surface antigen (Ag) and HIV Ab/Ag was 5.0% (44/886), 0.8% (7/886), and 0.2% (2/886). The adjusted odds for HCV Ab were highest in prisoners who ever injected (p < 0.001; AOR 24.6 CI 95% (5.5–215.2). The prevalence of detectable HCV RNA in the total cohort was 2.1% (19/886). Thirteen (68.4%) prisoners were redirected for follow-up of their HCV infection.

Conclusions
Opt-in testing for viral hepatitis B, C and HIV was relatively well-accepted in prisons. Compared with the general population, prisoners have a higher prevalence of infection with BBV, especially for HCV. Systematic screening for these BBV should be recommended in all prisons, preferably using opt-out to optimize screening uptake.

Trial registration
Retrospectively registered at clinical trials NCT04366492 April 29, 2020.
Scent dog identification of SARS-CoV-2 infections in different body fluids
Authors: Jendrny Paula , Twele Friederike , Meller Sebastian , Schulz Claudia , von Köckritz-Blickwede Maren , Osterhaus Albertus Dominicus Marcellinus Eras , Ebbers Hans , Ebbers Janek , Pilchová Veronika , Pink Isabell , Welte Tobias , Manns Michael Peter , Fathi Anahita , Addo Marylyn Martina , Ernst Christiane , Schäfer Wencke , Engels Michael , Petrov Anja , Marquart Katharina , Schotte Ulrich , Schalke Esther , Volk Holger Andreas 
Published: July 2021

Abstract
Background
The main strategy to contain the current SARS-CoV-2 pandemic remains to implement a comprehensive testing, tracing and quarantining strategy until vaccination of the population is adequate. Scent dogs could support current testing strategies.

Methods
Ten dogs were trained for 8 days to detect SARS-CoV-2 infections in beta-propiolactone inactivated saliva samples. The subsequent cognitive transfer performance for the recognition of non-inactivated samples were tested on three different body fluids (saliva, urine, and sweat) in a randomised, double-blind controlled study.

Results
Dogs were tested on a total of 5242 randomised sample presentations. Dogs detected non-inactivated saliva samples with a diagnostic sensitivity of 84% (95% CI: 62.5–94.44%) and specificity of 95% (95% CI: 93.4–96%). In a subsequent experiment to compare the scent recognition between the three non-inactivated body fluids, diagnostic sensitivity and specificity were 95% (95% CI: 66.67–100%) and 98% (95% CI: 94.87–100%) for urine, 91% (95% CI: 71.43–100%) and 94% (95% CI: 90.91–97.78%) for sweat, 82% (95% CI: 64.29–95.24%), and 96% (95% CI: 94.95–98.9%) for saliva respectively.

Conclusions
The scent cognitive transfer performance between inactivated and non-inactivated samples as well as between different sample materials indicates that global, specific SARS-CoV-2-associated volatile compounds are released across different body secretions, independently from the patient’s symptoms. All tested body fluids appear to be similarly suited for reliable detection of SARS-CoV-2 infected individuals.
Extracellular volume-guided late gadolinium enhancement analysis for non-ischemic cardiomyopathy: The Women’s Interagency HIV Study
Authors: Kato Yoko , Kizer Jorge R. , Ostovaneh Mohammad R. , Lazar Jason , Peng Qi , van der Geest Rob J. , Lima Joao A. C. , Ambale-Venkatesh Bharath 
Published: July 2021

Abstract
Background
Quantification of non-ischemic myocardial scar remains a challenge due to the patchy diffuse nature of fibrosis. Extracellular volume (ECV) to guide late gadolinium enhancement (LGE) analysis may achieve a robust scar assessment.

Methods
Three cohorts of 80 non-ischemic-training, 20 non-ischemic-validation, and 10 ischemic-validation were prospectively enrolled and underwent 3.0 Tesla cardiac MRI. An ECV cutoff to differentiate LGE scar from non-scar was identified in the training cohort from the receiver-operating characteristic curve analysis, by comparing the ECV value against the visually-determined presence/absence of the LGE scar at the highest signal intensity (SI) area of the mid-left ventricle (LV) LGE. Based on the ECV cutoff, an LGE semi-automatic threshold of n-times of standard-deviation (n-SD) above the remote-myocardium SI was optimized in the individual cases ensuring correspondence between LGE and ECV images. The inter-method agreement of scar amount in comparison with manual (for non-ischemic) or full-width half-maximum (FWHM, for ischemic) was assessed. Intra- and inter-observer reproducibility were investigated in a randomly chosen subset of 40 non-ischemic and 10 ischemic cases.

Results
The non-ischemic groups were all female with the HIV positive rate of 73.8% (training) and 80% (validation). The ischemic group was all male with reduced LV function. An ECV cutoff of 31.5% achieved optimum performance (sensitivity: 90%, specificity: 86.7% in training; sensitivity: 100%, specificity: 81.8% in validation dataset). The identified n-SD threshold varied widely (range 3 SD–18 SD), and was independent of scar amount (β = −0.01, p = 0.92). In the non-ischemic cohorts, results suggested that the manual LGE assessment overestimated scar (%) in comparison to ECV-guided analysis [training: 4.5 (3.2–6.4) vs. 0.92 (0.1–2.1); validation: 2.5 (1.2–3.7) vs. 0.2 (0–1.6); P < 0.01 for both]. Intra- and inter-observer analyses of global scar (%) showed higher reproducibility in ECV-guided than manual analysis with CCC = 0.94 and 0.78 versus CCC = 0.86 and 0.73, respectively (P < 0.01 for all). In ischemic validation, the ECV-guided LGE analysis showed a comparable scar amount and reproducibility with the FWHM.

Conclusions
ECV-guided LGE analysis is a robust scar quantification method for a non-ischemic cohort.
Trial registration ClinicalTrials.gov; NCT00000797, retrospectively-registered 2 November 1999; NCT02501811, registered 15 July 2015.
Sugar sweetened beverages attributable disease burden and the potential impact of policy interventions: a systematic review of epidemiological and decision models
Authors: Alcaraz Andrea , Pichon-Riviere Andrés , Palacios Alfredo , Bardach Ariel , Balan Dario Javier , Perelli Lucas , Augustovski Federico , Ciapponi Agustín 
Published: July 2021

Abstract
Background
Around 184,000 deaths per year could be attributable to sugar-sweetened beverages (SSBs) consumption worldwide. Epidemiological and decision models are important tools to estimate disease burden. The purpose of this study was to identify models to assess the burden of diseases attributable to SSBs consumption or the potential impact of health interventions.

Methods
We carried out a systematic review and literature search up to August 2018. Pairs of reviewers independently selected, extracted, and assessed the quality of the included studies through an exhaustive description of each model’s features. Discrepancies were solved by consensus. The inclusion criteria were epidemiological or decision models evaluating SSBs health interventions or policies, and descriptive SSBs studies of decision models. Studies published before 2003, cost of illness studies and economic evaluations based on individual patient data were excluded.

Results
We identified a total of 2766 references. Out of the 40 included studies, 45% were models specifically developed to address SSBs, 82.5% were conducted in high-income countries and 57.5% considered a health system perspective. The most common model’s outcomes were obesity/overweight (82.5%), diabetes (72.5%), cardiovascular disease (60%), mortality (52.5%), direct medical costs (57.35%), and healthy years -DALYs/QALYs- (40%) attributable to SSBs. 67.5% of the studies modelled the effect of SSBs on the outcomes either entirely through BMI or through BMI plus diabetes independently. Models were usually populated with inputs from national surveys -such us obesity prevalence, SSBs consumption-; and vital statistics (67.5%).
Only 55% reported results by gender and 40% included children; 30% presented results by income level, and 25% by selected vulnerable groups. Most of the models evaluated at least one policy intervention to reduce SSBs consumption (92.5%), taxes being the most frequent strategy (75%).

Conclusions
There is a wide range of modelling approaches of different complexity and information requirements to evaluate the burden of disease attributable to SSBs. Most of them take into account the impact on obesity, diabetes and cardiovascular disease, mortality, and economic impact. Incorporating these tools to different countries could result in useful information for decision makers and the general population to promote a deeper implementation of policies to reduce SSBs consumption.

PROSPERO protocol number
CRD42020121025.
Gender dimensions of the impact of HIV/AIDS on stunting in children under five years in Zimbabwe
Authors: Macheka Lesley , Kembo George , Kairiza Terrence 
Published: July 2021

Abstract
Background
HIV/AIDS can have a disastrous effect on household food and nutrition security outcomes such as stunting in children under 5. However, stunting and HIV/AIDS are highly gendered phenomena that need to be explored in order to get an in-depth understanding of the interrelationship. This study was therefore aimed at investigating gender dimensions of the impact of HIV/AIDS on stunting in children under 5 years in Zimbabwe.

Methods
The study uses a large scale nationally representative cross-sectional dataset of 13,854 Zimbabwean households for the year 2019. To test hypothesis 1, the study employs binary choice models (Probit and Logit) since the outcome variable household HIV/AIDS status is dichotomous. To test hypothesis 2 and 3, the study employs the Propensity Score Matching (PSM) approach to circumvent the self-selection problem in the creation of treatment and control groups for households affected by HIV/AIDS and those that are not.

Results
The results revealed that household HIV/AIDS status is independent of the gender of household head. On the other hand, the results for the PSM estimates show that the probability of the household having a stunted child under 5 years is higher for households with an HIV positive member compared to those without. In addition, female headed households with an HIV positive member are more likely to have a stunted child under 5 years compared to male headed households under similar circumstances.

Conclusion
Overall, the results provide evidence of a higher risk of stunting among children from households affected by HIV/AIDS. The study offers three major findings. Firstly, the study finds no significant association between gender of the household head and household HIV/AIDS status. Secondly, households that have at least one HIV positive member are more likely to have a stunted child under 5 years. Lastly, female headed households with at least one HIV positive member are more likely to have a stunted child under 5 years compared to male headed household with similar HIV/AIDS status. The findings have important policy implications towards improved integration of HIV/AIDS status, household head gender and child nutrition services in affected households.
Misclassification and characterization of exposure to humidifier disinfectants using a questionnaire
Authors: Ryu Hyeonsu , Choi Yoon-Hyeong , Kim Eunchae , Park Jinhyeon , Lee Seula , Yoon Jeonggyo , Jo Eun-Kyung , Choe Youngtae , Heo Jung , Yang Wonho 
Published: July 2021

Abstract
Background
Lung disease caused by exposure to chemical substances such as polyhexamethylene guanidine (PHMG) used in humidifier disinfectants (HDs) has been identified in Korea. Several researchers reported that exposure classification using a questionnaire might not correlate with the clinical severity classes determined through clinical diagnosis. It was asserted that the lack of correlation was due to misclassification in the exposure assessment due to recall bias. We identified the cause of uncertainty to recognize the limitations of differences between exposure assessment and clinical outcomes assumed to be true value. Therefore, it was intended to check the availability of survey using questionnaires and required to reduce misclassification error/bias in exposure assessment.

Methods
HDs exposure assessment was conducted as a face-to-face interview, using a questionnaire. A total of 5245 applicants participated in the exposure assessment survey. The questionnaire included information on sociodemographic and exposure characteristics such as the period, frequency, and daily usage amount of HDs. Based on clinical diagnosis, a 4 × 4 cross-tabulation of exposure and clinical classification was constructed. When the values of the exposure rating minus the clinical class were ≥ 2 and ≤ − 2, we assigned the cases to the overestimation and underestimation groups, respectively.

Results
The sex ratio was similar in the overestimation and underestimation groups. In terms of age, in the overestimation group, 90 subjects (24.7%) were under the age of 10, followed by 52 subjects (14.2%) in their 50s. In the underestimation group, 195 subjects (56.7%) were under the age of 10, followed by 80 subjects (23.3%) in their 30s. The overestimation group may have already recovered and responded excessively due to psychological anxiety or to receive compensation. However, relatively high mortality rates and surrogate responses observed among those under 10 years of age may have resulted in inaccurate exposure in the underestimation group.

Conclusions
HDs exposure assessment using a questionnaire might not correlate with adverse health effects due to recall bias and various other causes such as recovery of injury and psychological anxiety. This study revealed exposure misclassification and characteristics affected by HDs and proposed a questionnaire-based exposure assessment methodology to overcome the limitations of past exposure assessment.
To disclose, or not to disclose? Perspectives of clinical genomics professionals toward returning incidental findings from genomic research
Authors: AlFayyad Isamme , Al-Tannir Mohamad , Abu-Shaheen Amani , AlGhamdi Saleh 
Published: July 2021

Abstract
Background
Clinical genomic professionals are increasingly facing decisions about returning incidental findings (IFs) from genetic research. Although previous studies have shown that research participants are interested in receiving IFs, yet there has been an argument about the extent of researcher obligation to return IFs. We aimed in this study to explore the perspectives of clinical genomics professionals toward returning incidental findings from genomic research.

Methods
We conducted a national survey of a sample (n = 113) of clinical genomic professionals using a convenient sampling. A self-administered questionnaire was used to explore their attitudes toward disclosure of IFs, their perception of the duties to return IFs and identifying the barriers for disclosure of IFs. A descriptive analysis was employed to describe participants' responses.

Results
Sixty-five (57.5%) respondents had faced IFs in their practice and 31 (27.4%) were not comfortable in discussing IFs with their research subjects. Less than one-third of the respondents reported the availability of guidelines governing IFs. The majority 84 (80%) and 69 (62.7%) of the study participants indicated they would return the IFs if the risk of disease threat ≥ 50% and 6–49%, respectively and 36 (31.9%) reported they have no obligation to return IFs.

Conclusion
Clinical genomics professionals have positive attitudes and perceptions toward the returning IFs from genomic research, yet some revealed no duty to do so. Detailed guidelines must be established to provide insights into how genomics professionals should be handled IFs.