bluuebunny/crossref_metadata_2025_split huggingface dataset:
Is post-operative non-weight-bearing necessary? Study protocol for a pragmatic randomised multicentre trial of operatively treated ankle fracture
Authors: Khojaly Ramy E , Niocaill Ruairí Mac , Shahab Muhammad , Nagle Matthew , Taylor Colm , Rowan Fiachra E. , Cleary May 
Published: November 2020

Abstract
Background:Postoperative management regimes vary following open reduction and internal fixation (ORIF) of unstable ankle fractures. There is an evolving understanding that extended periods of immobilisation and limitation of weight-bearing may lead to poorer clinical outcomes. Traditional non-weight bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates.Methods:A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus non-weight-bearing (NWB) and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury) is proposed. All patients presenting to three trauma units will be included. The exclusion criteria will be skeletal immaturity and tibial plafond fractures. The three institutional review boards have granted ethical approval. The primary outcome measure will be the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes included wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. The trial will be reported in accordance with the CONSORT statement for reporting a pragmatic trial, and this protocol will follow the SPIRIT guidance.Discussion:Traditional management of operatively treated ankle fractures includes an extended period of non-weight bearing. There is emerging evidence that earlier weight-bearing may have equivocal outcomes and favourable patient satisfaction but with higher wound-related complications. These studies often preclude more complicated fracture patterns or patient-related factors. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner in recent decades. This pragmatic randomised-controlled multicentre trial will investigate immediate weight-bearing following ORIF of all ankle fracture patterns in the usual condition of care. It is hoped that these results will contribute to the modern management of ankle fractures.Trial registration:The trial is retrospectively registered on the 30th of June 2019, ISRCTN - ISRCTN76410775.http://www.isrctn.com/ISRCTN76410775
Effectiveness of the school-based social and behavior change communication (SBCC) interventions on insecticide-treated nets utilization among primary school children in rural Ethiopia: A quasi-experimental design
Authors: Ababulgu Fira Abamecha , Sudhakar Morankar , Gebretsadik Lakew Abebe , Lemu Yohannes Kebede , Alemayehu Guda , Koricha Zewdie Birhanu 
Published: November 2020

Abstract
Background: Evidence regarding the impacts of school-engaged social and behavior change communication (SBCC) interventions on malaria preventive behaviors in rural primary schools is limited. This study examined the effect of the school-based SBCC approach on the utilization of the insecticide-treated nets among primary school students in malaria-endemic settings of Ethiopia.Methods: Engaging primary schools and community; various participatory, educational, and communication interventions were implemented from 2017 to 2019 in 75 rural primary schools in Jimma to promote malaria preventive practices in target the villages. A post-intervention quasi-experimental design was conducted with randomly selected 798 students (i.e. 399 intervention and 399 control groups). Data were collected by trained interviewers using structured questionnaires. The SPSS version 26 software was used to analyze the data. Propensity score matching analysis was performed to control for possible confounding biases. The average effects of the intervention were estimated using multivariate general linear modeling and chi-square tests based on the nature of the outcome data. P-value < 5% was considered for statistical significance. Results: The result showed a significant difference of 39% in the proportion of ITN utilization between the intervention and control groups; (95% CI: 38.23% to 39.77%). The intervention also led to a significant mean differences (MD) of self-efficacy (MD=15.34; 95% CI: 13.73 to 16.95), knowledge (MD=5.83; 95% CI: 5.12 to 6.55), attitude (MD=6.01; 95% CI: 5.26 to 6.77), perceived malaria risk (MD=2.14; 95% CI: 1.53 to 2.76), and perceived family supports (MD=6.39; 95% CI: 5.57 to 7.22). Multiple logistic regression modeling results showed that knowledge (β=0.194, 95% CI: 1.09 to 1.35) and perceived family supports (β=0.165, 95% CI: 1.11 to 1.25) and self-efficacy (β=0.10, 95% CI: 1.22 to 2.32) significantly predicted the ITN utilization among the school children. Conclusion: The finding of this study suggested that the school-based SBCC approach combined with peer education activities advanced the malaria-related knowledge, attitude, self-efficacy, risk perceptions, and family supports and ultimately improved the sustained use of ITNs among school-going children. Further research should be conducted to understand the mechanism of these effects given the influences of social, health services, and school systems are considered.
Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy: Study Protocol for A Cluster Randomized Controlled Trial
Authors: Packel Laura , Njau Prosper , Fahey Carolyn , Ramadhani Angela , Dow William H , Jewell Nicholas P , McCoy Sandra I 
Published: November 2020

Abstract
Background: Antiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve HIV care and treatment outcomes, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. To address these questions and begin to bridge the “know-do gap” with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based intervention to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone Region, Tanzania.Methods: We will conduct a type I hybrid implementation – effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with an mobile health technology (mHealth) system. Specifically, our team will expand the intervention to 32 clinics and enroll 1,984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome; and (b) evaluate the implementation challenges and successes at multiple levels (patient, provider, clinic).Discussion: This trial will provide evidence about not only the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond.
The additional iron cable fixation between proximal patella and tibial tuberosity to treat AO/OTA 34C3 patellar fracture
Authors: Zhang Dongzheng , Shen Yong 
Published: November 2020

Abstract
Background:It is very difficult to deal with AO/OTA 34C3 patellar fracture. Although the modified Kirschner wire tension band, the cerclage and plate has been proposed to treat it, the result is not very good. We found that if the fixation was not firm enough after the modified Kirschner wire tension band with or without the cerclage had been carried out, the additional iron cable fixation between proximal patella and tibial tuberosity could resolve it effectively.Methods:Retrospective analysis was completed. 21 patients with AO/OTA 34C3 patellar fracture were treated in our department from January 2014 to January 2018. They were divided into 2 groups according to the operation plan. Group 1 (normal group), with 12 patients, was treated with modified Kirschner wire tension band with or without cerclage cable. Group 2 (cable group), with 9 patients, was treated with the additional iron cable fixation between proximal patella and tibial tuberosity when the fixation was not firm enough after the modified Kirschner wire tension band with or without the cerclage had been completed.Results:The two groups of the age, sex ratio, trauma mechanism, operation time, free articular fragment, comorbidity and follow-up time had no significant statistical difference (P>0.05). There was no significant statistical difference between the two groups of the clinical results. (such as Bostman total score and its specific individual score, the excellent and good ratio, the complications, and the bone union time, etc.) (P>0.05).Conclusions:To deal with AO/OTA 34C3 patellar fracture, when the fixation of modified Kirschner wire tension band with or without the cerclage cable is not firm enough, the additional iron cable fixation between proximal patella and tibial tuberosity can resolve it effectively.
Pattern-mixture model in network meta-analysis of binary missing outcome data: one-stage or two-stage approach?
Authors: Spineli Loukia Maria , Papadimitropoulou Katerina , Kalyvas Chrysostomos 
Published: November 2020

Abstract
Background: Trials with binary outcomes can be synthesised using within-trial exact likelihood or approximate normal likelihood in one-stage or two-stage approaches, respectively. The performance of the one-stage and the two-stage approaches has been documented extensively in the literature. However, little is known about how these approaches behave in the presence of missing outcome data (MOD), which are ubiquitous in trials. In this work, we compare the one-stage versus two-stage approach via a pattern-mixture model in the network meta-analysis using Bayesian methods to handle MOD appropriately.Methods: We used 29 published networks to empirically compare the two approaches concerning the relative treatment effects of several competing interventions and the between-trial variance ( ), while considering the extent and level of balance of MOD in the included trials. We additionally conducted a simulation study to compare the competing approaches regarding the bias and width of the 95% credible interval of the (summary) log odds ratios (OR) and in the presence of moderate and large MOD.Results: The empirical study did not reveal any systematic bias between the compared approaches regarding the log OR, but showed systematically larger uncertainty around the log OR under the one-stage approach for networks with at least one small trial or low event risk and moderate MOD. For these networks, the simulation study revealed that the bias in log OR for comparisons with the reference intervention in the network was relatively higher in the two-stage approach. Contrariwise, the bias in log OR for the remaining comparisons was relatively higher in the one-stage approach. Overall, bias increased for large MOD. For these networks, the empirical results revealed slightly higher estimates under the one-stage approach irrespective of the extent of MOD. The one-stage approach also led to less precise log OR and when compared with the two-stage approach for large MOD.Conclusions: Due to considerable bias in the log ORs overall, especially for large MOD, none of the competing approaches was superior. Until a more competent model is developed, the researchers may prefer the one-stage approach to handle MOD, while acknowledging its limitations.
A Cross-sectional, Multicenter, Observational Study to Assess the Prophylaxis of Venous Thromboembolism in Lebanese and Jordanian Hospitals
Authors: Hajj Imad , -Masri Mahmoud AL , Bashaireh Kaldoun , Hani Mohammed Bani , Hamouri Shadi , Khouzami Joe , Sabra Nisrine , Fadel Chahine 
Published: November 2020

Abstract
Background There is a growing body of evidence showing substantial underuse of appropriate venous thromboembolism (VTE) prophylaxis in patients at risk. In the present study, our goal was to assess the current practices in the use rate of VTE prophylaxis among hospitalized patients in Jordan and Lebanon.Methods A cross-sectional, multicenter, observational study was conducted on 40 centers across Lebanon and Jordan. We included patients who were admitted to the participating hospitals for the treatment of a serious medical or surgical illness. The patients’ records were screened for the fulfillment of inclusion/exclusion criteria during a single assessment visit. The proportion of medical and surgical patients who were at risk of VTE and the thrombo-prophylactic measures employed by physicians for these patients were assessed according to the American College of Chest Physicians (ACCP 2016) guidelines. Results The present study included 704 patients (400 from Jordan and 304 from Lebanon) with a mean age of 54.9 ±17.5 years. Almost 59% of the patients received prophylaxis treatment in form of pharmacological anticoagulant prophylaxis and/or mechanical prophylaxis. Low molecular weight heparin was the most commonly used anticoagulant for VTE prophylaxis in 366 out of the total 704 (51.9%) patients in the analysis cohort. Two hundred and sixteen patients (52 %, 95% confidence interval [47.1% - 56.9%]) received appropriate prophylactic agents out of 415 patients who were eligible for prophylaxis according to the ACCP 2016 guidelines. On the other hand, 199 (72.1%, 95% confidence interval [66.4% – 77.3%) patients received prophylaxis out of 276 ineligible patients.. The rate of compliance to guidelines showed wide variations according to the type of hospital, specialty, and the patients’ age. The multivariate logistic regression analysis showed that only age was a significant predictor of appropriate VTE prophylaxis (odds ratio [OR] 1.05, P <0.001).Conclusion The rates of the appropriate use of VTE prophylaxis are low in Lebanon and Jordan. There is a lack of compliance to guidelines for VTE prophylaxis use for hospitalized patients in both countries.
Endoscopic ultrasound-guided fine-needle aspiration of pelvic lesions via the upper and lower gastrointestinal tract approaches
Authors: Mita Naoki , Iwashita Takuji , Senju Akihiko , Ichikawa Hironao , Iwasa Yuhei , Yasuda Ichiro , Shimizu Masahito 
Published: November 2020

Abstract
Background: Combining upper and lower gastrointestinal tract (GI) approaches allows expansion of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) indications for pelvic lesions. The upper GI approach has been used for pelvic lesions around the level of the aortoiliac bifurcation in our institution. The aim of this study is to evaluate the feasibility and safety of EUS-FNA for pelvic lesions via the upper and lower GI approaches. Methods: All consecutive patients who underwent EUS-FNA for the pelvic lesion between January 2008 and December 2018 were retrospectively analyzed. Pelvic lesions were defined as lesions located around and below the aortoiliac bifurcation level. The primary outcome was technical success rate, and the secondary outcomes were the diagnostic capability of EUS-FNA for malignancy and the safety.Results: EUS-FNA for pelvic lesions was performed in 49 patients: upper and lower GI approaches were used in 28 and 21 patients, respectively. The technical success rates were 91.8% (45/49) in all patients: 89.3% (25/28) and 95.2% (20/21) with the upper and lower GI approaches, respectively. Among patients who achieved technical success, the diagnostic accuracy for malignancy was 97.8% (44/45) in all patients:100% (25/25) and 95.0% (19/20) with the upper and lower GI approaches, respectively. One (2.0%) patient developed an adverse event of sigmoid colon perforation.Conclusions: EUS-FNA for pelvic lesions via the upper and lower GI approaches was a safe, feasible, and effective method, although careful endoscopic manipulation is required to avoid perforation, especially with the lower GI approach. Further large-scale, well-designed studies are needed to validate our findings.
Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles Ameliorate Airway Inflammation in a Rat Model of chronic obstructive pulmonary disease (COPD)
Authors: Ridzuan Noridzzaida , Zakaria Norashikin , Widera Darius , Sheard Jonathan , Morimoto Mitsuru , Kiyokawa Hirofumi , Isa Seoparjoo Azmel Mohd , Singh Gurjeet Kaur Chatar , Then Kong-Yong , Ooi Ghee-Chien , Yahaya Badrul Hisham 
Published: November 2020

Abstract
Background: Chronic obstructive pulmonary disease (COPD) is an incurable and debilitating chronic disease characterized by progressive airflow limitation associated with abnormal levels of tissue inflammation. Therefore, stem cell-based approaches to tackle the condition are currently a focus of regenerative therapies for COPD. Extracellular vesicles (EVs) released by all cell types are crucially involved in paracrine, extracellular communication. Recent advances in the field suggest that stem cell-derived EVs possess a therapeutic potential which is comparable to the cells of their origin.Methods: In this study, we assessed the potential anti-inflammatory effects of human umbilical cord mesenchymal stem cell (hUC-MSCs) derived EVs in a rat model of COPD. EVs were isolated from hUC-MSCs and characterized by the transmission electron microscope, western blotting, and nanoparticle tracking analysis. As a model of COPD, male Sprague Dawley rats were exposed to cigarette smoke for up to 12 weeks, followed by transplantation of hUC-MSCs or application of hUC-MSCs-derived EVs. Lung tissue was subjected to histological analysis using hematoxylin and eosin staining, alcian blue-periodic acid Schiff (AB-PAS) staining, and immunofluorescence staining. Gene expression in the lung tissue was assessed using microarray analysis. Statistical analyses were performed using GraphPad Prism 7 version 7.0 (GraphPad Software, USA). Student’s t-test was used to compare between 2 groups. Comparison among more than 2 groups was done using one-way analysis of variance (ANOVA). Data presented as median±standard deviation (SD).Results: Both, transplantation of hUC-MSCs and application of EVs resulted in a reduction of peribronchial and perivascular inflammation, alveolar septal thickening associated with mononuclear inflammation, as well as a decreased number of goblet cells. Moreover, hUC-MSCs and EVs ameliorated the loss of alveolar septa in the emphysematous lung of COPD rats and reduced the levels of NF-κB subunit p65 in the tissue. Subsequent microarray analysis revealed that both hUC-MSCs and EVs significantly regulate multiple pathways known to be associated with COPD. Conclusions: In conclusion, we show that hUC-MSCs-derived EVs effectively ameliorate by COPD-induced inflammation. Thus, EVs could serve as a new cell-free based therapy for the treatment of COPD.
Recommendation Regarding the Cranial Upper Border of Level IIb in Delineating Clinical Target Volumes (CTV) for Nasopharyngeal Carcinoma
Authors: Wang Lijun , Huang Shengfu , Zhang Lanfang , He Xia , Liu Yatian 
Published: November 2020

Abstract
Purpose: To recommend a cranial border for level IIb in delineating clinical target volumes (CTV) for nasopharyngeal carcinoma (NPC) patients receiving intensity-modulated radiotherapy and to help reach a consensus on contouring level IIb in CTV.Methods: From 2012 to 2016, 331 nonmetastatic NPC patients treated with IMRT were retrospectively enrolled. Based on the AJCC 8th staging system of NPC, there were 15 stage I, 76 stage II, 103 stage III, and 137 stage IV patients. The distribution of cervical lymph nodes in NPC was assessed based on imaging. Comparisons of the safety and parotid dose parameters between patients with and without a reduction in the size of level IIb were conducted using SPSS 25.0 and R 2.14.2 software.Results: Metastasis rates in the most commonly involved lymph nodes, the lateral retropharyngeal and IIb nodes, were 82.8% and 64.0%, respectively. Among patients with level IIb involvement, the upper borders of the metastatic nodes were beyond the caudal edge of C1 in 13.7% of cases. The parotid gland D50 and V26 values were significantly reduced after modifying the upper bound of level IIb used to delineate the CTV (P = 0. 000).Conclusion: In principle, the upper bound of level IIb should reach the lateral skull base during delineation of the cervical CTV for NPC. To protect the parotid glands, however, individualized reduction of the upper bound of level IIb is recommended for patients who meet certain criteria.
Down-regulated RPS-30 in Angiostrongylus cantonensis L5 plays a defensive role against damage due to oxidative stress
Authors: Sun Wei-Wei , Yan Xiu-Mei , Shi Qing , Zhang Yuan-Jiao , Huang Jun-Ting , Huang Hui-Cong , Shi Hong-Fei , Yan Bao-Long 
Published: November 2020

Abstract
Background: Eosinophilic meningitis, caused by Angiostrongylus cantonensis L5, is mainly attributed to the Eosinophils, which contribute to tissue inflammatory responses in helminthic infections. Eosinophils are associated with helminthic killing, using the peroxidative oxidation and hydrogen peroxide (H2O2) generated by dismutation of superoxide produced during respiratory burst. In contrast, residing in the host with high level of eosinophils, helminthic worms have evolved to attenuate eosinophil-mediated tissue inflammatory responses for their survival in hosts. Our previous study demonstrated that the expression of Acan-rps-30 was significantly down-regulated in A. cantonensis L5 worms, which reside in the cerebrospinal fluid with high level of Eosinophils. Acan-RPS-30, a homologous protein of human Fau, which plays a pro-apoptotic regulatory role, may function in protecting worms from oxidative stress.Methods: RACE, genome Walking, bioinformatics were used to isolate and analyse the structural characterisation of Acan-RPS-30; qRT-PCR and microinjection was performed to detect the expression patterns of Acan-rps-30; feeding RNAi was used to ced-3 knock-down; microinjection was performed to construct transgenic worms; oxidative stress assay was used to determine the functions of Acan-RPS-30.Results: Our results showed that Acan-RPS-30 consisted of 130 amino acids, and was grouped into Clade V with C. elegans in phylogenetic analysis. It was expressed ubiquitously in worms and was down-regulated in both L5 and adult A. cantonensis. Worms expressing pCe-rps30::Acan-rps-30::rfp, with the refractile “button-like” apoptotic corpses, were susceptible to oxidative stress. Apoptosis genes ced-3 and ced-4 were both up-regulated in the transgenic worms. And the phenotype susceptible to oxidative stress could be converted with ced-3 defective mutation and RNAi. rps-30–/– mutant worms were resistant to oxidative stress, with ced-3 and ced-4 were both down-regulated. And the oxidative stress resistance phenotype could be rescued and inhibited by expressing pCe-rps30::Acan-rps-30::rfp in rps-30–/– mutant worms.Conclusion: In C. elegans worms, down-regulated RPS-30 plays a defensive role against damage due to oxidative stress for worm survival by regulating ced-3 down-regulated. And this might indicate the mechanism of A. cantonensis L5 worms, with Acan-RPS-30 down-regulated, surviving in the central nervous system of human from immune attack of Eosinophil.