bluuebunny/crossref_metadata_2025_split huggingface dataset:
Longitudinal study based on a safety registry for malaria patients treated with artenimol–piperaquine in six European countries
Authors: Vignier Nicolas , Bouchaud Olivier , Angheben Andrea , Bottieau Emmanuel , Calleri Guido , Salas-Coronas Joaquín , Martin Charlotte , Ramos José Manuel , Mechain Matthieu , Rapp Christophe , Nothdurft Hans-Dieter , Velasco Maria , Bardají Azucena , Rojo-Marcos Gerardo , Visser Leo G. , Hatz Christoph , Bisoffi Zeno , Jelinek Tomas , Duparc Stephan , Bourhis Yann , Tommasini Silva , Iannucelli Maurizio , Bacchieri Antonella , Mattera Giovan Giuseppe , Merlo Pich Emilio , Behrens Ronald H. 
Published: May 2021

Abstract
Background
European travellers to endemic countries are at risk of malaria and may be affected by a different range of co-morbidities than natives of endemic regions. The safety profile, especially cardiac issues, of artenimol (previously dihydroartemisinin)–piperaquine (APQ) Eurartesim® during treatment of uncomplicated imported falciparum malaria is not adequately described due to the lack of longitudinal studies in this population. The present study was conducted to partially fill this gap.

Methods
Participants were recruited through Health Care Provider’s safety registry in 15 centres across 6 European countries in the period 2013–2016. Adverse events (AE) were collected, with a special focus on cardiovascular safety by including electrocardiogram QT intervals evaluated after correction with either Bazett’s (QTcB) or Fridericia’s (QTcF) methods, at baseline and after treatment. QTcB and/or QTcF prolongation were defined by a value > 450 ms for males and children and > 470 ms for females.

Results
Among 294 participants, 30.3% were women, 13.7% of Caucasian origin, 13.5% were current smoker, 13.6% current alcohol consumer and 42.2% declared at least one illness history. The mean (SD) age and body mass index were 39.8 years old (13.2) and 25.9 kg/m2 (4.7). Among them, 75 reported a total of 129 AE (27 serious), 46 being suspected to be related to APQ (11 serious) and mostly labelled as due to haematological, gastrointestinal, or infection. Women and Non-African participants had significantly (p < 0.05) more AEs. Among AEs, 21 were due to cardiotoxicity (7.1%), mostly QT prolongation, while 6 were due to neurotoxicity (2.0%), mostly dizziness. Using QTcF correction, QT prolongation was observed in 17/143 participants (11.9%), only 2 of them reporting QTcF > 500 ms (milliseconds) but no clinical symptoms. Using QTcB correction increases of > 60 ms were present in 9 participants (6.3%). A trend towards increased prolongation was observed in those over 65 years of age but only a few subjects were in this group. No new safety signal was reported. The overall efficacy rate was 255/257 (99.2%).

Conclusions
APQ appears as an effective and well-tolerated drug for treatment of malaria in patients recruited in European countries. AEs and QT prolongation were in the range of those obtained in larger cohorts from endemic countries.
Trial registration This study has been registered in EU Post-Authorization Studies Register as EUPAS6942
The effect of different methods to identify, and scenarios used to address energy intake misestimation on dietary patterns derived by cluster analysis
Authors: Lo Siou Geraldine , Akawung Alianu K. , Solbak Nathan M. , McDonald Kathryn L. , Al Rajabi Ala , Whelan Heather K. , Kirkpatrick Sharon I. 
Published: May 2021

Abstract
Background
All self-reported dietary intake data are characterized by measurement error, and validation studies indicate that the estimation of energy intake (EI) is particularly affected.

Methods
Using self-reported food frequency and physical activity data from Alberta’s Tomorrow Project participants (n = 9847 men 16,241 women), we compared the revised-Goldberg and the predicted total energy expenditure methods in their ability to identify misreporters of EI. We also compared dietary patterns derived by k-means clustering under different scenarios where misreporters are included in the cluster analysis (Inclusion); excluded prior to completing the cluster analysis (ExBefore); excluded after completing the cluster analysis (ExAfter); and finally, excluded before the cluster analysis but added to the ExBefore cluster solution using the nearest neighbor method (InclusionNN).

Results
The predicted total energy expenditure method identified a significantly higher proportion of participants as EI misreporters compared to the revised-Goldberg method (50% vs. 47%, p < 0.0001). k-means cluster analysis identified 3 dietary patterns: Healthy, Meats/Pizza and Sweets/Dairy. Among both men and women, participants assigned to dietary patterns changed substantially between ExBefore and ExAfter and also between the Inclusion and InclusionNN scenarios (Hubert and Arabie’s adjusted Rand Index, Kappa and Cramer’s V statistics < 0.8).

Conclusions
Different scenarios used to account for EI misreporters influenced cluster analysis and hence the composition of the dietary patterns. Continued efforts are needed to explore and validate methods and their ability to identify and mitigate the impact of EI misestimation in nutritional epidemiology.
Critical evaluation of stents in coronary angioplasty: a systematic review
Authors: Stevens Joseph Robert , Zamani Ava , Osborne James Ian Atkins , Zamani Reza , Akrami Mohammad 
Published: May 2021

Abstract
Background
Coronary stents are routinely placed in the treatment and prophylaxis of coronary artery disease (CAD). Current coronary stent designs are prone to developing blockages: in-stent thrombosis (IST) and in-stent re-stenosis (ISR). This is a systematic review of the design of current coronary stent models, their structural properties and their modes of application, with a focus on their associated risks of IST and ISR. The primary aim of this review is to identify the best stent design features for reducing the risk of IST and ISR. To review the three major types of stents used in clinical settings today, determining best and relevant clinical practice by exploring which types and features of offer improved patient outcomes regarding coronary angioplasty. This information can potentially be used to increase the success rate of coronary angioplasty and stent technology in the future taking into account costs and benefits.

Methods
Scientific databases were searched to find studies concerning stents. After the exclusion criteria were applied, 19 of the 3192 searched literature were included in this review. Studies investigating three major types of stent design were found: bare-metal stents (BMS), drug-eluting stents (DES) and bioresorbable stents (BRS). The number of participants varied between 14 and 1264. On average 77.4% were male, with a mean age of 64 years.

Results
From the findings of these studies, it is clear that DES are superior in reducing the risk of ISR when compared to BMS. Conflicting results do not clarify whether BRS are superior to DES at reducing IST occurrence, although studies into newer BRS technologies show reducing events of IST to 0, creating a promising future for BRS showing them to be non-inferior. Thinner stents were shown to reduce IST rates, due to better re-endothelialisation. Scaffold material has also been shown to play a role with cobalt alloy stents reducing the risk of IST. This study found that thinner stents that release drugs were better at preventing re-blockages. Some dissolvable stents might be better at stopping blood clots blocking the arteries when compared to metal stents. The method and procedure of implanting the stent during coronary angioplasty influences success rate of these stents, meaning stent design is not the only significant factor to consider.

Conclusions
Positive developments in coronary angioplasty could be made by designing new stents that encompass all the most desirable properties of existing stent technology. Further work is needed to investigate the benefits of BRS in reducing the risk of IST compared to DES, as well as to investigate the effects of different scaffold materials on IST and ISR outcomes.
Psychometric properties of the Persian translation of maternal postpartum quality of life questionnaire (MAPP-QOL)
Authors: Mokhtaryan-Gilani Tahereh , Ozgoli Giti , Kariman Nourossadat , Sharif Nia Hamid , Ahmadi Doulabi Mahbobeh , Nasiri Malihe 
Published: May 2021

Abstract
Background and objective
Many studies have been conducted in Iran on the postpartum quality of life, and the majority have used the general quality of life questionnaire. With a specific tool in this context, the dimensions of maternal postpartum quality of life can be more accurately determined. The present study was conducted to determine psychometric properties and validate the Persian version of the Maternal Postpartum Quality of Life Questionnaire (MAPP-QOL).

Materials and methods
The present methodological study was conducted in 2018. The original version of MAPP-QOL was translated into Persian by both forward and backward translation. In a cross-sectional study, the Persian version was completed by 407 eligible postpartum women aged 18 to 47 and living in Tehran. Reliability of the questionnaire was assessed using Cronbach's alpha coefficient and test–retest. For construct validity, exploratory and confirmatory factor analyses were used.

Results
The MAPP-QOL showed good content validity; content validity ratio (CVR) ranged from 0.6 to 1.00, and content validity index (CVI) ranged from 0.7 to 1.00. Using exploratory factor analysis, five factors, including Socioeconomic; Relational/Family-Friends; Psychological/Baby; Health & functioning; and Relational/Spouse-Partner, were extracted, which together explained 78.84% of the total variance. After modifications of CFA, the confirmatory factor analysis showed an acceptable goodness-of-fit. AVE value Above 0.5 exhibited appropriate convergent validity, and AVE greater than MSV confirmed divergent validity. The Cronbach's alpha, McDonald's Omega, Composite reliability and maximum reliability H of the five extracted factors were excellent (> 0.9). Also, the AIC values of the factors were good (between 0.721 to 0.859).

Conclusion
The 38-item Persian version of the postpartum quality of life questionnaire is adequately reliable for postpartum women in Iran. Given its appropriate psychometric properties, this scale is fit to be used in future studies on postpartum women.
Predictive value of pretreatment PD-L1 expression in EGFR-mutant non-small cell lung cancer: a meta-analysis
Authors: Peng Zhiyu , Lin Huahang , Zhou Ke , Deng Senyi , Mei Jiandong 
Published: May 2021

Abstract
Objective
To investigate the predictive value of programmed death-ligand 1 (PD-L1) expression in non-small cell lung cancer (NSCLC) patients treated with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs).

Methods
We conducted a systemic search of PubMed, EMBASE, and the Cochrane Library from 1 January 2000 to 30 August 2020, to identify related studies. We combined the hazard ratio (HR) and 95% confidence interval (CI) to assess the correlation of PD-L1 expression with progression-free survival (PFS) and overall survival (OS). We assessed the quality of the included studies by the Newcastle–Ottawa Scale (NOS). We performed subgroup analyses based on immunohistochemistry (IHC) scoring system, IHC antibodies, sample size, countries, and survival analysis mode. Sensitivity analysis and evaluation of publication bias were also performed.

Results
Twelve studies including 991 patients met the criteria. The mean NOS score was 7.42 ± 1.19. Patients with high PD-L1 expression was associated with poorer PFS (HR = 1.90; 95% CI = 1.16–3.10; P = 0.011), while there was no association between PD-L1 expression and OS (HR = 1.19; 95% CI = 0.99–1.43; P = 0.070). Subgroup analysis prompted IHC scoring systems, IHC antibodies, and sample size have important effects on heterogeneity. The pooled results were robust according to the sensitivity analysis.

Conclusions
The result of this meta-analysis suggested that PD-L1 expression might be a predictive biomarker for EGFR-mutant non-small cell lung cancer treated with EGFR-TKIs.
Application of stem cell-derived exosomes in ischemic diseases: opportunity and limitations
Authors: Babaei Majid , Rezaie Jafar 
Published: May 2021

AbstractIschemic diseases characterized by an insufficient blood flow that leads to a decrease in oxygen and nutrient uptake by cells have emerged as an important contributor to both disability and death worldwide. Up-regulation of angiogenesis may be a key factor for the improvement of ischemic diseases. This article searched articles in PubMed with the following keywords: stem cells, exosomes, angiogenesis, ischemic diseases either alone or in grouping form. The most relevant selected items were stem cell-derived exosomes and ischemic diseases. A growing body of evidence indicates that stem cells produce exosomes, which is the novel emerging approach to cell-to-cell communication and offers a new standpoint on known therapeutic strategies of ischemic diseases. Exosomes transport biological molecules such as many types of proteins, RNAs, DNA fragments, signaling molecules, and lipids between cells. Different stem cells release exosomes representing beneficial effects on ischemic diseases as they promote angiogenesis both in vitro and in vivo experiments. Application of exosomes for therapeutic angiogenesis opened new opportunities in the regenerative medicine, however, some limitations regarding exosomes isolation and application remain concerned. In addition, most of the experiments were conducted in preclinical and therefore translation of these results from bench to bed requires more effort in this field. Exosomes from stem cells are a promising tool for the treatment of ischemic diseases. In addition, translation of pre-clinic results into clinic needs further studies in this field.
Cost-effectiveness analysis of a quality improvement program to reduce caesarean sections in Brazilian private hospitals: a case study
Authors: Domingues Rosa Maria Soares Madeira , Luz Paula Mendes , da Silva Ayres Barbara Vasques , Torres Jacqueline Alves , do Carmo Leal Maria 
Published: May 2021

Abstract
Background
In 2015, a quality improvement project of childbirth care called Adequate Childbirth Project (“Projeto Parto Adequado”- PPA) was implemented in Brazilian public and private hospitals, aiming to improve the quality of childbirth care and to reduce caesarean sections without clinical indications. The objective of this study is to conduct an economic analysis of two models of care existing in a private Brazilian hospital—the model following the recommendations of the PPA and the standard of care model—in reducing the proportion of caesarean sections.

Methods
We conducted a cost-effectiveness analysis using data from one of the private hospitals included in the PPA project. The main outcome was the proportion of caesarean section. We used total cost of hospitalization for women and newborns, from the health care sector perspective, during the length of the observed hospital stay. We did not apply discount rates and inflation rate adjustments due to the short time horizon. We conducted univariate sensitivity analysis using the minimum and maximum costs observed in hospitalizations and variation in the probabilities of caesarean section and of maternal and neonatal complications.

Results
238 puerperal women were included in this analysis. The PPA model of care resulted in a 56.9 percentage point reduction in the caesarean section probability (88.6% vs 31.7%, p < 0.001) with an incremental cost-effectiveness ratio of US$1,237.40 per avoided caesarean section. Women in the PPA model of care also had a higher proportion of spontaneous and induced labor and a lower proportion of early term births. There were no maternal, fetal or neonatal deaths and no significant differences in cases of maternal and neonatal near miss. The cost of uncomplicated vaginal births and caesarean sections was the parameter with the greatest impact on the cost-effectiveness ratio of the PPA model of care.

Conclusion
The PPA model of care was cost-effective in reducing caesarean sections in women assisted in a Brazilian private hospital. Moreover, it reduced the frequency of early term births and did not increase the occurrence of severe negative maternal and neonatal outcomes.
CircASH2L facilitates tumor-like biologic behaviours and inflammation of fibroblast-like synoviocytes via miR-129-5p/HIPK2 axis in rheumatoid arthritis
Authors: Li Xia , Qu Meiting , Zhang Jie , Chen Kuanyin , Ma Xianghui 
Published: May 2021

Abstract
Background
Previous study showed that circular RNA Absent-Small-Homeotic-2--Like protein (circASH2L) was higher in rheumatoid arthritis (RA) patients. However, the roles and mechanisms of circASH2L in RA progression remain unclear.

Methods
Levels analysis was conducted using western blot and qRT-PCR. The proliferation, apoptosis, cell cycle progression, migration, invasiveness, and inflammation of RA fibroblast-like synoviocytes (RA-FLSs) were determined via MTT, flow cytometry, western blot, transwell, and ELISA assays.

Results
CircASH2L knockdown in RA-FLSs suppressed cell proliferative, migratory, and invasive capacities, triggered cell cycle arrest, promoted apoptosis, and inhibited inflammation. Mechanistically, circASH2L targeted miR-129-5p, and repression of miR-129-5p abolished the functions of circASH2L silencing on the growth, motility, and inflammation of RA-FLSs. Besides, miR-129-5p was found to directly target HIPK2, and suppressed the tumor-like biologic behaviors and inflammation of RA-FLSs via regulating HIPK2. Importantly, we proved that circASH2L could modulate HIPK2 expression via miR-129-5p.

Conclusion
CircASH2L promoted RA-FLS growth, motility, and inflammation through miR-129-5p/HIPK2 axis.
Comparison of two methods in the treatment of congenital pseudarthrosis of clavicle: multicenter experience
Authors:   Chinese Multi-center Pediatric Orthopedic Study Group (CMPOS), Li Jin , Tang Sheng Ping , Mei Hai Bo , Shao Jing Fan , Shi Bao Jie , Wang Hai Qiang , Tang Xin 
Published: May 2021

Abstract
Background
Congenital pseudoarthrosis of the clavicle (CPC) is an uncommon entity. Owing to its scarce presentation, treatment of this disorder has not been well established. This study aimed (1) to compare surgical treatment methods that included excision of pseudoarthrosis and iliac crest bone graft and fixate with either the elastic stable intramedullary nail (ESIN) or K-wires or plate and screws, and (2) to assess the clinical outcomes of two different surgical methods.

Methods
A multi-central retrospective study was performed between 2013 and 2017 in four tertiary teaching hospitals. Fifteen clavicles of 11 children were identified as CPC. All patients underwent pseudarthrosis resection and iliac crest bone autograft. They were divided into two groups as per the surgical treatment they underwent—plate stabilization as group A and elastic stable intramedullary nailing (ESIN) or K-wires as group B. Nine clavicles in 6 patients in group A and 6 clavicles in 5 patients in group B, were included. The Quick Disabilities of the Arm and Shoulder (QuickDASH) score was used to assess patients’ satisfaction and function following treatment at each follow-up.

Results
There were eight boys and three girls, with an average age of 4.7 years. All patients, except one with intellectual impairments, had radiological healing. Implant removal time was significantly shorter in group B compared to group A. No statistically significant differences existed in terms of age at surgery, time of radiological healing, complication, and clinical outcome between different groups.

Conclusion
Surgical resection of pseudoarthrosis with an iliac crest bone graft was an effective means of surgical treatment in CPC. However, ESIN or K-wires can achieve shorter union time compared to the plate. Hence, surgical treatment is recommended for congenital pseudarthrosis of clavicular in pediatric patients.

Level of evidence
Retrospective comparative study; Level III
Accuracy of soft tissue balancing in total knee arthroplasty using surgeon-defined assessment versus a gap-balancer or electronic sensor
Authors: Zhao Ran , Liu Yanqing , Tian Hua 
Published: May 2021

Abstract
Background
Soft tissue balancing is essential for the success of total knee arthroplasty (TKA) and is mainly dependent on surgeon-defined assessment (SDA) or a gap-balancer (GB). However, an electronic sensor has been developed to objectively measure the gap pressure. This study aimed to evaluate the accuracy of soft tissue balancing using SDA and GB compared with a sensor.

Methods
Forty-eight patients undergoing TKA (60 knees) were prospectively enrolled. Soft tissue balancing was sequentially performed using SDA, a GB, and an electronic sensor. We compared the SDA, GB, and sensor data to calculate the sensitivity, specificity, and accuracy at 0°, 45°, 90°, and 120° flexion. Cumulative summation (CUSUM) analysis was performed to assess the surgeon’s performance during the sensor introductory phase.

Results
The sensitivity of SDA was 63.3%, 68.3%, 80.0%, and 80.0% at 0°, 45°, 90°, and 120°, respectively. The accuracy of the GB compared with sensor data was 76.7% and 71.7% at 0° and 90°, respectively.
Cohen’s kappa coefficient for the accuracy of the GB was 0.406 at 0° (moderate agreement) and 0.227 at 90° (fair agreement). The CUSUM 0° line achieved good prior performance at case 45, CUSUM 90° and 120° showed a trend toward good prior performance, while CUSUM 45° reached poor prior performance at case 8.

Conclusion
SDA was a poor predictor of knee balance. GB improved the accuracy of soft tissue balancing, but was still less accurate than the sensor, particularly for unbalanced knees. SDA improved with ongoing use of the sensor, except at 45° flexion.
Muscle pedicle bone flap transplantation for treating femoral neck fracture in adults: a systematic review
Authors: Wu Yipeng , Song Muguo , Peng Guangliang , Xu Yongqing , Li Yang , Wei Mingjie , Tang Hui , Lv Qian , Wang Teng , Cai Xingbo 
Published: May 2021

AbstractBackgroundThis systematic review was conducted to gather available evidence on the effectiveness of muscle pedicle bone flap transplantation in adult patients with femoral neck fractures.MethodsDatabases such as PubMed, EMBASE, IEEE, Web of Science, and Cochrane library were searched from their dates of inception until March 2021. Two reviewers independently selected the interventional studies on the assessment of the effectiveness of muscle pedicle bone flap transplantation for femoral neck fractures; data extraction and assessment of the methodological quality as per the Institute of Health Economics quality appraisal checklist were also performed by the reviewers. The effectiveness and complication outcomes were assessed by calculating the average rates.ResultsOverall, 20 studies with 1022 patients were included in this review. Notably, the methodologic quality of the included studies was typically poor. The average effective rates were as follows: good, 73.4%; fair, 15.4%; and poor, 10.9%. Moreover, the average nonunion rate, average avascular necrosis rate, average collapse rate, and the overall reoperation rate were 9.0%, 6.7%, 4.7%, and 7.3%, respectively.ConclusionsThis systematic review of heterogeneous studies with varying number of patients and varying surgical techniques indicated that muscle pedicle bone flap transplantation provides promising results with low rates of avascular necrosis and nonunion. Nevertheless, further controlled studies are required to ascertain the effectiveness of muscle pedicle bone flap transplantation in treating femoral neck fracture.