bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical trial monitoring effectiveness: Remote risk-based monitoring versus on-site monitoring with 100% source data verification
Authors: Yamada Osamu , Chiu Shih-Wei , Takata Munenori , Abe Michiaki , Shoji Mutsumi , Kyotani Eri , Endo Chiyo , Shimada Minami , Tamura Yuko , Yamaguchi Takuhiro 
Published: December 2020

Background/Aims: Traditional on-site monitoring of clinical trials via frequent site visits and 100% source data verification is cost-consuming, and it still cannot guarantee data quality effectively. Depending on the types and designs of clinical trials, an alternative would be combining several monitoring methods, such as risk-based monitoring and remote monitoring. However, there is insufficient evidence of its effectiveness. This research compared the effectiveness of risk-based monitoring with a remote monitoring system with that of traditional on-site monitoring. Methods: With a cloud-based remote monitoring system called beagle View®, we created a remote risk-based monitoring methodology that focused only on critical data and processes. We selected a randomized controlled trial conducted at Tohoku University Hospital and randomly sampled 11 subjects whose case report forms had already been reviewed by data managers. Critical data and processes were verified retrospectively by remote risk-based monitoring; later, all data and processes were confirmed by on-site monitoring. We compared the ability of remote risk-based monitoring to detect critical data and process errors with that of on-site monitoring with 100% source data verification, including an examination of clinical trial staff workload and potential cost savings. Results: Of the total data points (n = 5617), 19.7% (n = 1105, 95% confidence interval = 18.7–20.7) were identified as critical. The error rates of critical data detected by on-site monitoring, remote risk-based monitoring, and data review by data managers were 7.6% (n = 84, 95% CI = 6.2–9.3), 7.6% (n = 84, 95% confidence interval = 6.2–9.3), and 3.9% (n = 43, 95% confidence interval = 2.9–5.2), respectively. The total number of critical process errors detected by on-site monitoring was 14. Of these 14, 92.9% (n = 13, 95% confidence interval = 68.5–98.7) and 42.9% (n = 6, 95% confidence interval = 21.4–67.4) of critical process errors were detected by remote risk-based monitoring and data review by data managers, respectively. The mean time clinical trial staff spent dealing with remote risk-based monitoring was 9.9 ± 5.3 (mean ± SD) min per visit per subject. Our calculations show that remote risk-based monitoring saved between 9 and 41 on-site monitoring visits, corresponding to a cost of between US$13,500 and US$61,500 per trial site. Conclusion: Remote risk-based monitoring was able to detect critical data and process errors as well as on-site monitoring with 100% source data verification, saving travel time and monitoring costs. Remote risk-based monitoring offers an effective alternative to traditional on-site monitoring of clinical trials.
Smartphone use by health professionals: A review
Authors: King Anna Lucia Spear , Pádua Mariana King , Gonçalves Lucio Lage , Santana de Souza Martins Aline , Nardi Antonio Egidio 
Published: December 2020

Introduction On the world stage unlimited internet access by smartphones have made in social, cultural and economic relations, has transformed the world to be faster and more efficient. In this context, health care requires more attention. Health professionals must be concerned about the majority of the patient’s care on the use of smartphone’s in this process. Smartphones can be cause distractions and cause poor patient care. Behavioral and psychological changes related to abusive and uncontrolled use in this population may create severe impacts not only on the user’s life but also on the community health care. Method A careful research was performed through PubMed, Web of Science and Psycho Info databases using the terms: “Smartphone addiction”, “Smartphone dependence”, “Smartphone abuse”, “physicians”, “nurses” and ‘‘health professionals”. The search covered the past 5 years up to August 2019. Articles that examine abusive use on smartphones in health professionals were included. We analyzed how this concept evolved over the last five years and hope to contribute to the better understanding of the issue and its impacts on this population and on the health care. Results There is a lack of specific trial instruments on screening of smartphone addiction or abusive use, tending to adopt different diagnostic criteria by the reports included. There are also a lack of studies discussing etiology of this compulsive behavior. Although known risks, published reports show there is no consciousness of abusive use and possible damages in healthcare by some health professionals. Instead, there are others that can affirm there are unpredictable risks in patient care and tend to stimulate conscience use politics in health settings. Most of them point out smartphone’s app benefits. Conclusion Smartphones and its functionalities became part of everyone's life by the various benefits guaranteed. However, an addictive behavior can cause damage, principally in the Health Care setting and health professional’s abusive use must be monitored. Further investigation is needed to determine the motivations of this addictive behavior and if abusive smartphone usage is a new psychiatric classification or merely the substrate of other disorders.
Effect of Bruton tyrosine kinase inhibitor on efficacy of adjuvanted recombinant hepatitis B and zoster vaccines
Authors: Pleyer Christopher , Ali Mir A. , Cohen Jeffrey I. , Tian Xin , Soto Susan , Ahn Inhye E. , Gaglione Erika M. , Nierman Pia , Marti Gerald E. , Hesdorffer Charles , Lotter Jennifer , Superata Jeanine , Wiestner Adrian , Sun Clare 
Published: December 2020

Abstract
Vaccinations are effective in preventing infections; however, it is unknown if patients with chronic lymphocytic leukemia (CLL) who are treatment naïve (TN) or receiving Bruton tyrosine kinase inhibitors (BTKi's) respond to novel adjuvanted vaccines. Understanding the effect of BTKi's on humoral immunity is timely because BTKi's are widely used and vaccination against coronavirus disease 2019 is urgently needed. In 2 open-label, single-arm clinical trials, we measured the effect of BTKi's on de novo immune response against recombinant hepatitis B vaccine (HepB-CpG) and recall response against recombinant zoster vaccine (RZV) in CLL patients who were TN or on BTKi. The primary end point was serologic response to HepB-CpG (anti-hepatitis B surface antibodies ≥10 mIU/mL) and RZV (≥fourfold increase in anti-glycoprotein E). The response rate to HepB-CpG was lower in patients on BTKi (3.8%; 95% confidence interval [CI], 0.7-18.9) than patients who were TN (28.1%; 95% CI, 15.6-45.4; P = .017). In contrast, the response rate to RZV did not differ significantly between the BTKi (41.5%; 95% CI, 27.8-56.6) and TN cohorts (59.1%; 95% CI, 38.7-76.7; P = .2). BTKi's were associated with a decreased de novo immune response following HepB-CpG, whereas recall immune response following RZV was not significantly affected by BTKi therapy. These trials were registered at www.clinicaltrials.gov as #NCT03685708 (Hep-CpG) and #NCT03702231 (RZV).
Zebrafish Kit ligands cooperate with erythropoietin to promote erythroid cell expansion
Authors: Oltova Jana , Svoboda Ondrej , Machonova Olga , Svatonova Petra , Traver David , Kolar Michal , Bartunek Petr 
Published: December 2020

AbstractKit ligand (Kitlg) is pleiotropic cytokine with a prominent role in vertebrate erythropoiesis. Although the role of Kitlg in this process has not been reported in Danio rerio (zebrafish), in the present study we show that its function is evolutionarily conserved. Zebrafish possess 2 copies of Kitlg genes (Kitlga and Kitlgb) as a result of whole-genome duplication. To determine the role of each ligand in zebrafish, we performed a series of ex vivo and in vivo gain- and loss-of-function experiments. First, we tested the biological activity of recombinant Kitlg proteins in suspension culture from zebrafish whole-kidney marrow, and we demonstrate that Kitlga is necessary for expansion of erythroid progenitors ex vivo. To further address the role of kitlga and kitlgb in hematopoietic development in vivo, we performed gain-of-function experiments in zebrafish embryos, showing that both ligands cooperate with erythropoietin (Epo) to promote erythroid cell expansion. Finally, using the kita mutant (kitab5/b5 or sparse), we show that the Kita receptor is crucial for Kitlga/b cooperation with Epo in erythroid cells. In summary, using optimized suspension culture conditions with recombinant cytokines (Epo, Kitlga), we report, for the first time, ex vivo suspension cultures of zebrafish hematopoietic progenitor cells that can serve as an indispensable tool to study normal and aberrant hematopoiesis in zebrafish. Furthermore, we conclude that, although partial functional diversification of Kit ligands has been described in other processes, in erythroid development, both paralogs play a similar role, and their function is evolutionarily conserved.
Antimicrobial resistance and metallo-beta-lactamase producing among commensal Escherichia coli isolates from healthy children of Khuzestan and Fars provinces; Iran
Authors: Mahmoodi Fahimeh , Rezatofighi Seyedeh Elham , Akhoond Mohammad Reza 
Published: December 2020

AbstractBackgroundThe emergence of metallo-β-lactamase (MBL)-producing isolates is alarming since they carry mobile genetic elements with great ability to spread; therefore, early detection of these isolates, particularly their reservoir, is crucial to prevent their inter- and intra-care setting dissemination and establish suitable antimicrobial therapies. The current study was designed to evaluate the frequency of antimicrobial resistance (AMR), MBL producers and identification of MBL resistance genes inEscherichia colistrains isolated from fecal samples of the healthy children under 3 years old. A total of 412 fecalE. coliisolates were collected from October 2017 to December 2018. The study population included healthy infants and children aged < 3 years who did not exhibit symptoms of any diseases, especially gastrointestinal diseases.E. coliisolates were assessed to determine the pattern of AMR.E. coliisolates were assessed to determine the pattern of AMR, the production of extended spectrum β-lactamase (ESBL) and MBL by phenotypic methods. Carbapenem-resistant isolates were investigated for the presence of MBL and carbapenemase genes, plasmid profiling, and the ability of conjugation.ResultsIn sum, AMR, multi-drug resistance (MDR) and ESBL production were observed in more than 54.9, 36.2 and 11.7% of commensalE. coliisolates, respectively. Out of six isolates resistant to imipenem and meropenem, four isolates were phenotypically detected as MBL producers. Two and oneE. colistrains carried theblaNDM-1andblaVIM-2genes, respectively and were able to transmit imipenem resistance through conjugation.ConclusionOur findings showed that children not exposed to antibiotics can be colonized byE. coliisolates resistant to the commonly used antimicrobial compounds and can be a good indicator for the occurrence and prevalence of AMR in the community. These bacteria can act as a potential reservoir of AMR genes including MBL genes of pathogenic bacteria and lead to the dissemination of resistance mechanisms to other bacteria.
Characterization of the virulence of Pseudomonas aeruginosa strains causing ventilator-associated pneumonia
Authors: Alonso Beatriz , Fernández-Barat Laia , Di Domenico Enea Gino , Marín Mercedes , Cercenado Emilia , Merino Irene , de Pablos Manuela , Muñoz Patricia , Guembe María 
Published: December 2020

Abstract
Background
The objective of this study was to evaluate the virulence of P. aeruginosa ventilator-associated pneumonia (VAP) strains (cases) in terms of biofilm production and other phenotypic and genotypic virulence factors compared to P. aeruginosa strains isolated from other infections (controls).

Methods
Biofilm production was tested to assess biomass production and metabolic activity using crystal violet binding assay and XTT assay, respectively. Pigment production (pyocyanin and pyoverdine) was evaluated using cetrimide agar. Virulence genes were detected by conventional multiplex PCR and virulence was tested in an in vivo model in Galleria mellonella larvae.

Results
We did not find statistically significant differences between VAP and no-VAP strains (p > 0.05) regarding biofilm production. VAP strains had no production of pyocyanin after 24 h of incubation (p = 0.023). The distribution of virulence genes between both groups were similar (p > 0.05). VAP strains were less virulent than non-VAP strains in an in vivo model of G. mellonella (p < 0.001).

Conclusion
The virulence of VAP-Pseudomonas aeruginosa does not depend on biofilm formation, production of pyoverdine or the presence of some virulence genes compared to P. aeruginosa isolated from non-invasive locations. However, VAP strains showed attenuated virulence compared to non-VAP strains in an in vivo model of G. mellonella.
Do you pay to go private?: a single centre comparison of induction of labour and caesarean section rates in private versus public patients
Authors: Craven Simon , Byrne Fionnuala , Mahony Rhona , Walsh Jennifer M. 
Published: December 2020

Abstract
Background
The aim of this study was to compare rates of induction and subsequent caesarean delivery among nulliparous women with private versus publicly funded health care at a single institution. This is a retrospective cohort study using the electronic booking and delivery records of nulliparous women with singleton pregnancies who delivered between 2010 and 2015 in an Irish Tertiary Maternity Hospital (approx. 9000 deliveries per annum).

Methods
Data were extracted from the National Maternity Hospital (NMH), Dublin, Patient Administration System (PAS) on all nulliparous women who delivered a liveborn infant at ≥37 weeks gestation during the 6-year period. At NMH, all women in spontaneous labour are managed according to a standardised intrapartum protocol. Twenty-two thousand two hundred thirty-two women met the inclusion criteria. Of these, 2520 (12.8%) were private patients; the remainder (19,712; 87.2%) were public. Mode of and gestational age at delivery, rates of and indications for induction of labour, rates of pre-labour caesarean section, and maternal and neonatal outcomes were examined. Rates of labour intervention and subsequent maternal and neonatal outcomes were compared between those with and without private health cover.

Results
Women attending privately were more than twice as likely to have a pre-labour caesarean section (12.7% vs. 6.5%, RR = 2.0, [CI 1.8–2.2])); this finding persisted following adjustment for differences in maternal age and body mass index (BMI) (adjusted relative risk 1.74, [CI 1.5–2.0]). Women with private cover were also more likely to have induction of labour and significantly less likely to labour spontaneously. Women who attended privately were significantly more likely to have an operative vaginal delivery, whether labour commenced spontaneously or was induced.

Conclusions
These findings demonstrate significant differences in rates of obstetric intervention between those with private and public health cover. This division is unlikely to be explained by differences in clinical risk factors as no significant difference in outcomes following spontaneous onset of labour were noted. Further research is required to determine the roots of the disparity between private and public decision-making. This should focus on the relative contributions of both mothers and maternity care professionals in clinical decision making, and the potential implications of these choices.
Comparison of the effects of rapid maxillary expansion versus Twin Block appliance on mandibular growth in skeletal Class II patients
Authors: Zhang Jia-Nan , Chen Si , Huang Cheng-Yi , Zhong Chong , Jin Jing , Yu Feng-Yang , Zhang Zan-Zan , Lu Hai-Ping 
Published: December 2020

Abstract
Background
This is a retrospective study that compares mandibular growth changes in skeletal Class II patients treated by rapid maxillary expansion (RME) and following fixed appliance with those patients treated by Twin-Block (TB) and following fixed appliance.

Methods
Fourteen patients treated by RME and following fixed appliance were included into the RME group. Fifteen patients treated by Twin-Block and following fixed appliance were included into the TB group. Lateral cephalometric radiographs taken before treatment and immediately after fixed appliance treatment were used to evaluate mandibular growth effects.

Results
The starting forms of the patients in the two groups were examined to be of good comparability. The mandibular length increased significantly in both groups as measured by Co-Gn, Go-Gn and Ar-Gn, but the TB group didn’t show more mandibular growth than the RME group (P > 0.05). Skeletal changes of the mandible in vertical dimension were different in the two groups. The change in FMA was 0.35° in the RME group, while the change was 2.65° in the TB group (P < 0.001). The change in LAFH was 5.14 mm in the RME group, significantly smaller than the change of 10.19 mm in the TB group (P < 0.001).

Conclusion
The investigated Phase I treatment with RME followed by Phase II treatment of fixed appliance achieved the same increases in sagittal mandibular growth and facial profile improvements as the Twin-Block therapy. The treatment with RME followed by fixed appliance was better for vertical control, while the treatment with Twin-Block followed by fixed appliance significantly increased the mandibular plane angle.
RETRACTED ARTICLE: LncRNA SNHG12 regulates the radiosensitivity of cervical cancer through the miR-148a/CDK1 pathway
Authors: Wang Chen , Shao Shiqing , Deng Li , Wang Shelian , Zhang Yongyan 
Published: December 2020

Abstract
Background
Radiation resistance is a major obstacle to the prognosis of cervical cancer (CC) patients. Many studies have confirmed that long non-coding RNAs (lncRNAs) are involved in the regulation of radiosensitivity of cancers. However, whether small nucleolar RNA host gene 12 (SNHG12) regulates the radiosensitivity of CC remains unknown.

Methods
Quantitative real-time polymerase chain reaction was used to measure the expression levels of SNHG12 and microRNA-148a (miR-148a). The radiosensitivity of cells was evaluated by clonogenic assay. Flow cytometry and caspase-3 activity assay were performed to assess the apoptosis ability and cell cycle distribution of cells. Besides, dual-luciferase reporter and RNA immunoprecipitation assay were used to verify the interaction between miR-148a and SNHG12 or cyclin-dependent kinase 1 (CDK1). Also, the protein levels of CDK1, CCND1 and γ-H2AX were detected by western blot analysis. Furthermore, in vivo experiments were conducted to verify the effect of SNHG12 on CC tumor growth. Ki-67 and TUNEL staining were employed to evaluate the proliferation and apoptosis rates in vivo. The hematoxylin and eosin (HE) staining were employed to evaluate the tumor cell morphology.

Results
SNHG12 was upregulated in CC tissues and cells, and its knockdown improved the radiosensitivity by promoting the radiation-induced apoptosis and cell cycle arrest of CC cells. Also, miR-148a could be sponged by SNHG12 and could target CDK1. MiR-148a inhibitor or CDK1 overexpression could invert the promotion effect of silenced-SNHG12 on CC radiosensitivity. Meanwhile, SNHG12 interference reduced the tumor growth of CC, increased miR-148a expression, and inhibited CDK1 level in vivo.

Conclusion
LncRNA SNHG12 promoted CDK1 expression to regulate the sensitivity of CC cells to radiation through sponging miR-148a, indicating that SNHG12 could be used as a potential biomarker to treat the radiotherapy resistance of CC patients.
Factors associated with increasing rural doctor supply in Asia-Pacific LMICs: a scoping review
Authors: Putri Likke Prawidya , O’Sullivan Belinda Gabrielle , Russell Deborah Jane , Kippen Rebecca 
Published: December 2020

Abstract
Background
More than 60% of the world’s rural population live in the Asia-Pacific region. Of these, more than 90% reside in low- and middle-income countries (LMICs). Asia-Pacific LMICs rural populations are more impoverished and have poorer access to medical care, placing them at greater risk of poor health outcomes. Understanding factors associated with doctors working in rural areas is imperative in identifying effective strategies to improve rural medical workforce supply in Asia-Pacific LMICs.

Method
We performed a scoping review of peer-reviewed and grey literature from Asia-Pacific LMICs (1999 to 2019), searching major online databases and web-based resources. The literature was synthesized based on the World Health Organization Global Policy Recommendation categories for increasing access to rural health workers.

Result
Seventy-one articles from 12 LMICs were included. Most were about educational factors (82%), followed by personal and professional support (57%), financial incentives (45%), regulatory (20%), and health systems (13%). Rural background showed strong association with both rural preference and actual work in most studies. There was a paucity in literature on the effect of rural pathway in medical education such as rural-oriented curricula, rural clerkships and internship; however, when combined with other educational and regulatory interventions, they were effective. An additional area, atop of the WHO categories was identified, relating to health system factors, such as governance, health service organization and financing. Studies generally were of low quality—frequently overlooking potential confounding variables, such as respondents’ demographic characteristics and career stage—and 39% did not clearly define ‘rural’.

Conclusion
This review is consistent with, and extends, most of the existing evidence on effective strategies to recruit and retain rural doctors while specifically informing the range of evidence within the Asia-Pacific LMIC context. Evidence, though confined to 12 countries, is drawn from 20 years’ research about a wide range of factors that can be targeted to strengthen strategies to increase rural medical workforce supply in Asia-Pacific LMICs. Multi-faceted approaches were evident, including selecting more students into medical school with a rural background, increasing public-funded universities, in combination with rural-focused education and rural scholarships, workplace and rural living support and ensuring an appropriately financed rural health system. The review identifies the need for more studies in a broader range of Asia-Pacific countries, which expand on all strategy areas, define rural clearly, use multivariate analyses, and test how various strategies relate to doctor’s career stages.