bluuebunny/crossref_metadata_2025 huggingface dataset:
Isokinetic training – its radiographic and inflammatory effects on chronic low back pain
Authors: Nambi Gopal , Abdelbasset Walid Kamal , Alsubaie Saud F. , Moawd Samah A. , Verma Anju , Saleh Ayman K. , Ataalla Nahla N.
Published: December 2020

Background:

Isokinetic training (IKT) and core stabilization training (CST) are commonly used for balance training in musculoskeletal conditions. The knowledge about the effective implementation of these training protocols on radiological and biochemical effects in university football players with chronic low back pain (LBP) is lacking.

Objective:

To find and compare the effects of isokinetic training and CST on radiological and biochemical effects in university football players with chronic LBP.

Design:

Randomized, double-blinded controlled study.

Setting:

University hospital.

Participants:

60 LBP participants were randomized into isokinetic group (IKT; n = 20), core stabilization group (CST; n = 20) and the control group (n = 20) and received respective exercises for 4 weeks.

Outcome measures:

Radiological (muscle cross sectional area & muscle thickness) and biochemical (C-reactive protein, tumor necrosis factor -α, interleukin [IL]-2, IL-4, IL-6) values were measured at baseline and after 4 weeks (immediate effect).

Results:

The reports of the IKT, CST and control group were compared between the groups. Four weeks following training IKT group shows more significant changes in muscle cross sectional area (Psoas Major, Quadratus Lumborum, Multifidus and Erector Spinae muscles) and muscle thickness (Multifidus) than CST and control groups (p < 0.001). Biochemical measures such as C-reactive protein, tumor necrosis factor -α, IL-2, IL-4 and IL-6 also show significant improvement in IKT group than the other 2 groups (P < .001).

Conclusion:

Training through Isokinetic is an effective treatment program than conventional exercise programs in the aspect of radiological and biochemical analysis in university football players with chronic LBP, which may also help to prevent further injury. The present study can be used to improve the physical therapist's knowledge and clinical decision skills on LBP in football players.
Administration with corticosteroid relieving pain following total knee arthroplasty
Authors: Zhang Jiao , Huang Ji-xun
Published: December 2020

Background:

This meta-analysis compares the effectiveness of corticosteroid in relieving pain and inflammation in total knee arthroplasty (TKA) patients.

Method:

Randomized controlled trials in PubMed (1996 to March 2020), Embase (1996 to March 2020), and the Cochrane Library (CENTRAL, March 2020) compared corticosteroid and placebo in pain in TKA patients were identified by a software and manual searching. The risk of bias and clinical relevance of the included studies were assessed. Sensitivity analysis was performed by omitting each study in turn. The major outcomes of the studies were analyzed by the Stata 12.0.

Results:

13 randomized controlled trials that involved 193 patients were included in the present meta-analysis. The results of the study revealed a significantly lower visual analog scale (VAS) score of pain at rest in the corticosteroid group (12 hours: weighted mean difference (WMD)=−1.35, P = .005; 24 hours: WMD=−1.11, P = .000; 48 hours: WMD=−0.31, P = .000; 72 hours: WMD = −0.30, P = .000). And Postoperative VAS scores during mobilization at 12 hours and 24  hours were significantly lower at corticosteroid group when compared with control group (12 hours: WMD = −0.81, P = 0.000; 24 hours: WMD = −1.66, P = .018). Meta-analyses show that administration of corticosteroid can reduce the length of hospital stay, incidence nausea and the C-reactive protein level. While no significant difference was observed in the VAS scores during mobilization at 48 hours and 72 hours and total morphine consumption (P > .05).

Conclusions:

Compared to the control group, intraoperative corticosteroid was benefit to the pain management in TKA. However, more high-quality studies are still warranted to further validate our findings, considering there are several limitations in this meta-analysis.
Efficacy of Omaha system-based nursing management on nutritional status in patients undergoing peritoneal dialysis
Authors: Peng Liqing , Gao Yuanyuan , Lu Rong , Zhou Ruixiang
Published: December 2020

The chronic kidney disease (CKD) patients may have a variety of complications during receiving peritoneal dialysis (PD). The malnutrition in CKD patients is related to their lower life quality, higher hospitalization rates, and higher risk of cardiovascular disease, as well as the increased morbidity and mortality. Hence, it is very important to monitor and then manage the nutritional status of CKD patients. Thus, we perform this randomized controlled study protocol to introduce a continuing nursing program based on Omaha system (OS) for the patients with CKD receiving PD treatment.

The randomized trial will be implemented from November 2020 to May 2021 and was granted through the Research Ethics Committee of Wuhan No.1 Hospital (2020003281). Two hundred patients meet inclusion criteria and exclusion criteria are included.

Patients who meet the following criteria will be selected: voluntary participation, aged 20 to 60; undergoing the regular PD treatment for at least 3 months. Patients will be excluded if the patients are in unstable status, or experience the intermittent PD or some other kinds of dialysis mode, have severe cachexia, infection, or malnutrition, or if they have mental disorders. In control group, patients are given routine treatment, containing general guidance associated with PD and the outpatient telephone calls from the clinical nurses during follow-up. In study group, the patients are given the continuous nursing treatment scheme based on OS. The clinical results are the biochemical parameters after intervention, anthropometry, as well as the subjective global assessment.

Table 1 reveals the clinical endpoints between the 2 groups.

This protocol can guide nurses to develop a nursing program based on evidence for patients with CKD receiving PD.

Trial registration:

This study protocol was registered in Research Registry (researchregistry6202).
Histidine-tryptophan-ketoglutarate solution versus University of Wisconsin solution in adult-to-adult living donor liver transplantation
Authors: Xu Xi , Zhu Yun-Feng , Lv Tao , Zheng Jin-Li , Li Yong-kun , Zhang Bo-Han , Jiang Li , Yang Jia-yin
Published: December 2020

To compare the difference between University of Wisconsin (UW) solution and histidine-tryptophan-ketoglutarate (HTK) solution in adult living donor liver transplantation (LDLT).

This study included LDLT patients at the Liver Transplantation Center of West China Hospital of Sichuan University from November 2001 to June 2018. These patients were classified into 2 groups depending on the use of the different preservation solutions, and the confounding factors between the 2 groups were eliminated by propensity score matching. Finally, the incidence of complications; serum examination at postoperative days 1, 3, 5, 7, 14, 21, and 30; and the overall survival rate of the 2 groups were compared to observe whether there were any differences between the 2 preservation solutions.

Of the 298 patients we screened, 170 were treated with UW solution and 128 with HTK solution. After propensity score matching, 106 pairs of patients were selected. In the comparison of the 2 groups, the length of intensive care unit stay in the UW group was significantly longer than that in the HTK group (P = .022), but there was no difference in the total length of hospital stay between the 2 groups (P = .277). No statistically significant difference was observed in the 2 groups in terms of the incidence of complications or postoperative examinations. However, the incidence of early allograft dysfunction in the HTK group was slightly lower than that in the UW group (HTK: UW = 14.1%: 20.7%), although the difference was not statistically significant. In terms of the overall survival rate, the 1, 3, and 5-year survival rates of the HTK group were 85.5%, 70.2%, and 65.1%, respectively, while the 1, 3, and 5-year survival rates of the UW group were 83.1%, 67.2%, and 59.8%, respectively, and there was no significant difference between the 2 groups.

In conclusion, our study shows that UW solution and HTK solution are equivalent in perioperative safety, the recovery of transplanted liver function, the occurrence of postoperative complications and overall survival and can be safely and effectively applied in adult LDLT. If economic factors are taken into account, HTK can save costs to a certain extent.
Methylenetetrahydrofolate reductase C677T and A1298C polymorphisms and male infertility risk
Authors: Han Li-Juan , He Xiao-Feng , Ye Xiang-Hua
Published: December 2020

Background:

18 previous meta-analyses have been published on the methylenetetrahydrofolate reductase (MTHFR) C677T and A1298C polymorphisms with male infertility risk. However, results of the previous meta-analyses were still inconsistent. Moreover, their meta-analyses did not assess false-positive report probabilities except one study. Furthermore, many new studies have been published, and therefore an updated meta-analysis and re-analysis of systematic previous meta-analyses were performed to further explore these issues.

Objectives:

To determine the association between MTHFR C677T and A1298C polymorphisms and male infertility risk.

Methods:

Crude odds ratios and their 95% confidence intervals were used to assess the association between MTHFR C677T and A1298C polymorphisms and male infertility risk. We used the Bayesian false discovery probability (BFDP) to assess the credibility of statistically significant associations.

Results:

Fifty-nine studies were included concerning the MTHFR C677T and 28 studies were found on the MTHFR A1298C with male infertility risk. Overall, the MTHFR C677T was associated with increased male infertility risk in overall populations, Africans, East Asians, West Asians, South Asians, azoospermia, and Oligoasthenoteratozoospermia (OAT). In further sensitivity analysis and BFDP test, the positive results were only considered as “noteworthy” in the overall population (TT vs CC: BFDP = 0.294, CT + TT vs CC: BFDP = 0.300, T vs C: BFDP = 0.336), East Asians (TT vs CC: BFDP = 0.089, TT vs CT + CC: BFDP = 0.020, T vs C: BFDP < 0.001), West Asians (TT vs CC: BFDP = 0.584), hospital-based studies (TT vs CC: BFDP = 0.726, TT vs CT + CC: BFDP = 0.126), and OAT (TT vs CT + CC: BFDP = 0.494) for MTHFR C677T. In addition, a significantly increased male infertility risk was found in East Asians and population-based studies for MTHFR A1298C. However, we did not find that the positive results were considered as “noteworthy” in the overall and all subgroup analyses for MTHFR A1298C.

Conclusions:

In summary, this study indicates that the MTHFR C677T is associated with increased male infertility risk in East Asians, West Asians, and OAT. No significant association was observed on the MTHFR A1298C with male infertility risk.
Evaluation of a web-based intervention in patients with chronic human immunodeficiency virus infection
Authors: Mao Meihua , Jiang Gongying , Jiang Qiaofei
Published: December 2020

Background:

The infection of human immunodeficiency virus (HIV) is 1 of the major causes of morbidity and mortality in the world. People with chronic diseases have a higher risk of depression. The HIV people are more likely to suffer from depression. Appropriate psychosocial interventions are effective, but their accessibility is limited by the resources needed for their transmission. Thus, it makes sense to develop more cost-effective alternatives, for instance the web-based intervention (WBI), which may be effective for the well-being and depression. The aim of our program is to explore the effects of a WBI on depressive symptoms and well-being in HIV-infected patients.

Method:

It is a randomized controlled experiment to be conducted from February 2021 to July 2021. It was permitted through the Ethics Committee of Changshan County People's Hospital (no.60928376). This study includes 100 HIV patients. Inclusion criteria: (1)18 + years, on effective antiretroviral therapy≥ 1 year before inclusion. Exclusion criteria: patients with severe kidney, liver, lung, and heart diseases. Patients are divided randomly into the study group and control group, each group is assigned 50. The primary results are subjective well-being and depressive symptoms, while the secondary result involves the patients’ satisfaction with life.

Results:

The following Table 1 will exhibit the comparison of outcomes between 2 groups.

Conclusion:

HIV infected patients can benefit from WBI, which can be utilized as an adjunct to medical treatment.

Trial registration number:

researchregistry6215.
Internal treatment in traditional Chinese medicine for patients with COVID-19
Authors: Zhang Mingxu , Huang Ju , Wu Xinhui , Lv Lizeyu , Huang Anming , Zhu Siquan
Published: December 2020

Background:

The safety and effectiveness of Internal Treatment in Traditional Chinese Medicine (TCM) on Corona Virus Disease 2019 (COVID-19) is the main subject of this protocol for systematic review and meta-analysis.

Methods:

The following online databases will be searched from inception to April 2020: Cochrane Central Register of Controlled Trials, PubMed, Web of Science, EMBASE, China National Knowledge Infrastructure, Traditional Chinese Medicine, Chinese Biomedical Literature Database, Wan-Fang Database, and Chinese Scientific Journal Database. All published randomized controlled trials in English or Chinese related to Internal Treatment in Traditional Chinese Medicine for COVID-19 will be included. Primary outcomes are time of disappearance of main symptoms and serum cytokine levels. Secondary outcomes is Accompanying symptoms disappear rate, negative COVID-19 results rate on 2 consecutive occasions CT image improvement, average hospitalization time, occurrence rate of common type to severe form, clinical cure rate, and mortality. Two reviewers will conduct the study selection, data extraction, and assessment independently. The assessment of risk of bias and data synthesis will be conducted with Review Manager Software V.5.2.

Results:

The results will provide a high-quality synthesis of current evidence for researchers in this subject area.

Conclusion:

The conclusion of our study will provide evidence to judge whether the internal treatment in traditional Chinese medicine is an effective intervention for COVID-19 patients.

PROSPERO registration number:

CRD42020180178.
Digital technologies for monitoring infected people, identifying contacts and tracking transmission chains in the corona virus disease 2019 pandemic
Authors: de Souza Talita Araujo , de Almeida Medeiros Arthur , Barbosa Isabelle Ribeiro , de Vasconcelos Torres Gilson
Published: December 2020

Background:

In times of the corona virus disease 2019 (COVID-19) pandemic, due to the urgent need to respond quickly to the challenges posed by the introduction of a new etiological agent and the peculiarity of the disease, which poses risks to people's lives and health, the use of digital technologies for monitoring and surveillance have been used as a means of fighting coronavirus. Thus, this study will identify the use of digital technologies to monitor, identify contacts and track transmission chains of COVID-19 worldwide.

Methods:

The systematic review of this protocol will follow the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes Protocols. We will include studies that present digital technologies used in the monitoring of infected people, contact identification and the transmission chain of COVID-19 developed worldwide. For the selection of articles, the following databases will be consulted: PubMed, EMBASE, LILACS, Web of Science, Science Direct, Scopus, Livivo and CINAHL. In addition, we will conduct extensive research on selected sources of gray literature, including bibliographic databases, web-based search engines, practice-oriented magazines and government websites. Data extraction will take place in 2 stages (1- title and abstract screening and 2- full-text screening) and will be carried out independently by 2 reviewers, using the Mendeley software and the Rayyan QCRI application. The studies will be characterized as to the type and design of the study in relation to the ease in demonstrating the technologies used and the type of information produced. If it is necessary to synthesize quantitative data, the heterogeneity assessment will be performed using I2 statistics, and the meta-analysis will be processed using Review Manager 5.3.

Results:

The development of this research will allow the knowledge of how these technologies were applied according to each territory and their effectiveness in reducing cases of COVID-19.

Conclusion:

The results of this review can reveal the importance of modern technologies for reducing cases of COVID-19 and that these measures can be adopted by governments, organizations and for everyone

Record of systematic review:

CRD42020211744.
Effectiveness and safety of Xinyin tablet in treatment of chronic heart failure
Authors: Liu Qingqing , Huang Xi , Tian Mingyang , Dong Xiaoming , Kang Jinhua , Liao Huili , Liu Jianhong , Ling Yan , Long Wenjie , Yang Zhongqi
Published: December 2020

Background:

Xinyin Tablet (XYT) has been widely used in the treatment of CHF, Which helping to improve the clinical symptoms, enhance exercise, and even may improve the long-term prognosis of patients. However, the exact effectiveness and safety of XYT for CHF has not be comprehensively researched, so we want to generalize the effectiveness and safety of XYT for CHF through the meta-analysis, which may benefit the design of future clinical trials and provide valuable references.

Methods:

This protocol complies with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. From the inception until September 2020, a systematic and comprehensive electronic search about Relevant randomized controlled trials will be conducted in 4 English literature databases and 4 Chinese literature databases. The registration number: INPLASY2020100015. 2 investigators will be arranged to deal with the study selection and data extraction independently. The New York Heart Function Classification, traditional Chinese medicine (TCM) symptom scores, the scores of quality of life, 6-min walk distance (6MWD), etc. will be systematically measured as outcomes. At last, the data will be handled by Review Manager 5.3 and Stata 15.0.

Results and conclusion:

This study is hoping to provide a high-level evidence to prove the therapeutic effect of XYT on CHF, which may enhance the application of Chinese medicine.
The effects of exercise therapy on the prognosis of patients with COVID-19
Authors: Qiu Guorong , Ji Yu , Tan Yajun , He Benxiang , Tan Chunfeng , Wang Zhuoling , Gao Hongpan
Published: December 2020

Background:

Since the COVID-19 outbreak in 2020, more than 20 million people worldwide have been diagnosed with COVID-19, and all health care workers are looking for ways to improve the cure rate of the disease. As an important method of rehabilitation therapy, exercise therapy has been proved to improve the level of human function, promote the recovery of diseases, and improve the human immune ability. The main objective of this study was to provide reliable methods and credible evidence for exercise therapy to improve the prognosis of COVID-19 patients.

Methods and analysis:

The scheme was systematically reviewed in accordance with the preferred reporting items. We searched the following experimental databases: Cochrane Library, PubMed, EMBASE, Web of Science, China Biomedical Literature Database (CBM), China National Knowledge Infrastructure Database (CNKI), China Science and Wanfang Database. All trials using exercise therapy for rehabilitation of COVID-19 patients in the above database should be considered for inclusion. Relevant randomised controlled trials(RCTS), controlled before and after, interrupted time series and prospective analytic cohort studies regardless of publication date, language and geographic location, will be included. To summarize the therapeutic effect of exercise therapy on COVID-19 patients, high-quality literature was selected for data extraction and analysis. Two reviewers will independently screen titles, abstracts and full-text articles against inclusion criteria; perform data extraction and assess risk of bias in included studies. We will assess the certainty of the overall evidence using the Grading of Recommendations Assessment, Development and Evaluation approach and report findings accordingly.

Results:

In this study, we hope to summarize effective exercise therapy that can improve the prognosis of COVID-19 patients and find strong evidence for it.

Conclusions:

The conclusions of this study will provide reliable evidence to determine whether exercise and exercise therapy can improve the prognosis of COVID-19 patients and guide future studies.

PROSPERO registration number:

CRD42020209025.
Novel therapeutic compounds for prostate adenocarcinoma treatment
Authors: Li Kai , Fan Jingyuan , Qin Xinyi , Wei Qingjun
Published: December 2020

Introduction:

Prostate adenocarcinoma is the most frequently diagnosed malignancy, particularly for people >70 years old. The main challenge in the treatment of advanced neoplasm is bone metastasis and therapeutic resistance for known oncology drugs. Novel treatment methods to prolong the survival time and improve the life quality of these specific patients are required. The present study attempted to screen potential therapeutic compounds for the tumor through bioinformatics approaches, in order to provide conceptual treatment for this malignant disease.

Methods:

Differentially expressed genes were obtained from the Gene Expression Omnibus database and submitted into the Connectivity Map database for the detection of potentially associated compounds. Target genes were extracted from the search results. Functional annotation and pathway enrichment were performed for the confirmation. Survival analysis was used to measure potential therapeutic effects.

Results:

It was revealed that 3 compounds (vanoxerine, tolnaftate, and gabexate) may help to prolong the disease-free survival time from tumor metastasis of patients with the tumor. A total of 6 genes [also-keto reductase family 1 member C3 (AKR1C3), collagen type III α 1 chain (COL3A1), lipoprotein lipase (LPL), glucuronidase, β pseudogene 11 (GUSBP11), apolipoprotein E (APOE), and collagen type I α 1 chain (COL1A1)] were identified to be the potential therapeutic targets for the aforementioned compounds.

Conclusion:

In the present study, it was speculated that 3 compounds may function as the potential therapeutic drugs of bone metastatic prostate adenocarcinoma; however, further studies verifying vitro and in vivo are necessary.
Metabolic and immunological evaluation of patients with indeterminate and cardiac forms of Chagas disease
Authors: Rocha Ivonete Helena , Ferreira Marques Ana Luisa , Moraes Giselle Vanessa , Alves da Silva Djalma Alexandre , Silva Marcos Vinicius da , Rodrigues Virmondes , Cunha Daniel Ferreira da , Correia Dalmo
Published: December 2020

Chagas disease affects approximately 7 million people, causing disability and mortality in the most productive life stages of infected individuals. Considering the lifestyle of the world population, metabolic syndrome is a synergistic factor for an increased cardiovascular risk of patients with Chagas disease.

This study transversally evaluated the metabolic and immunological profiles of patients with indeterminate (IF) and cardiac (CF) forms of Chagas disease and their correlations with left ventricular dysfunction (LVD).

Clinical and electrical bioimpedance analysis, levels of cytokines (interferon [IFN]-γ, tumor necrosis factor [TNF]-α, interleukin [IL]-17, IL-10, and IL-33) and adipocytokines (adiponectin, leptin, and resistin), metabolic syndrome components, and brain natriuretic peptide (BNP) levels were assessed in 57 patients (13 IF and 44 CF) with a mean age of 61.63 ± 12.1 years. Chest x-ray, electrocardiogram, and echocardiogram were performed to classify the clinical forms.

The CF group had a higher number of individuals with metabolic syndrome components blood pressure altered, while more participants in the CF group with LVD had low high-density lipoprotein (HDL) levels. The IF group had more participants with a higher waist-to-hip ratio (WHR). No significant difference was observed between metabolic syndrome, cytokine and adipocytokine level, and clinical forms of the disease or in relation to LVD.

Individuals with the IF showed metabolic and immunological profiles compatible with increased disease control, whereas those with CF showed marked inflammatory immune response.
Tumor-associated macrophages based signaling pathway analysis and hub genes identification in glioma
Authors: Wang Xiang , Ning Weihai , Qiu Zhiqiang , Li Shenglun , Zhang Hongwei , Yu Chunjiang
Published: December 2020

Tumor-associated macrophages (TAMs) play a crucial role in the immune response to many malignancies, but the signaling pathways by which the glioma microenvironment cross-talk with TAMs are poorly understood. The aim of this study was to uncover the potential signaling pathways of the regulation of TAMs and identify candidate targets for therapeutic intervention of glioma through bioinformatics analysis.

Chinese Glioma Genome Atlas (CGGA) and The Cancer Genome Atlas (TCGA) datasets were used to download RNA-Seq data and microarray data of human glioma specimen. Differentially expressed genes (DEGs) between CD68-high samples and CD68-low samples were sorted. Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis of the DEGs was conducted. Protein-protein interaction (PPI) network were formed to identify the hub genes.

The prognostic value of TAMs in glioma patients was confirmed. A total of 477 specific DEGs were sorted. The signaling pathway was identified in pathway enrichment and the DEGs showed prominent representations of immune response networks in glioma. The hub genes including C3, IL6, ITGB2, PTAFR, TIMP1 and VAMP8 were identified form the PPI network and they were all correlated positively with the expression of CD68 and showed the excellent prognostic value in glioma patients.

TAMs can be used as a good prognostic indicator in glioma patients. By analyzing comprehensive bioinformatics data, we uncovered the underlying signaling pathway of the DEGs between glioma patients with high and low expression level of CD68. Furthermore, the 6 hub genes identified were closely associated with TAMs in glioma microenvironment and need further investigation.
Avoidable Serum Potassium Testing in the Cardiac ICU: Development and Testing of a Machine-Learning Model
Authors: Patel Bhaven B. , Sperotto Francesca , Molina Mathieu , Kimura Satoshi , Delgado Marlon I. , Santillana Mauricio , Kheir John N.
Published: December 2020

Objectives:

To create a machine-learning model identifying potentially avoidable blood draws for serum potassium among pediatric patients following cardiac surgery.

Design:

Retrospective cohort study.

Setting:

Tertiary-care center.

Patients:

All patients admitted to the cardiac ICU at Boston Children’s Hospital between January 2010 and December 2018 with a length of stay greater than or equal to 4 days and greater than or equal to two recorded serum potassium measurements.

Interventions:

None.

Measurements and Main Results:

We collected variables related to potassium homeostasis, including serum chemistry, hourly potassium intake, diuretics, and urine output. Using established machine-learning techniques, including random forest classifiers, and hyperparameter tuning, we created models predicting whether a patient’s potassium would be normal or abnormal based on the most recent potassium level, medications administered, urine output, and markers of renal function. We developed multiple models based on different age-categories and temporal proximity of the most recent potassium measurement. We assessed the predictive performance of the models using an independent test set. Of the 7,269 admissions (6,196 patients) included, serum potassium was measured on average of 1 (interquartile range, 0–1) time per day. Approximately 96% of patients received at least one dose of IV diuretic and 83% received a form of potassium supplementation. Our models predicted a normal potassium value with a median positive predictive value of 0.900. A median percentage of 2.1% measurements (mean 2.5%; interquartile range, 1.3–3.7%) was incorrectly predicted as normal when they were abnormal. A median percentage of 0.0% (interquartile range, 0.0–0.4%) critically low or high measurements was incorrectly predicted as normal. A median of 27.2% (interquartile range, 7.8–32.4%) of samples was correctly predicted to be normal and could have been potentially avoided.

Conclusions:

Machine-learning methods can be used to predict avoidable blood tests accurately for serum potassium in critically ill pediatric patients. A median of 27.2% of samples could have been saved, with decreased costs and risk of infection or anemia.
Nonlabens ponticola sp. nov., isolated from seawater and reclassification of Nonlabens sediminis as a later heterotypic synonym of Nonlabens tegetincola
Authors: Seo Ye Lin , Jung Jaejoon , Song Chi-une , Kwon Yong Min , Jung Hye Su , Eyun Seong-il , Jeon Che Ok
Published: December 2020

A Gram-stain-negative, orange-pigmented and strictly aerobic bacterium, designated strain MJ115T, was isolated from seawater in Pohang, South Korea. Cells were non-motile rods and showed positive reactions for catalase and oxidase tests. Growth of strain MJ115T was observed at 4–35 °C (optimum, 30 °C), pH 6.0–7.0 (optimum, pH 6.5) and in the presence of 0–8.0 % (w/v) NaCl (optimum, 2.0%). Strain MJ115T contained iso-C15 : 0, anteiso-C15 : 0, anteiso-C17 : 1
 ω9c, C17 : 0 2-OH, iso-C16 : 0 3-OH, iso-C17 : 0 3-OH and summed feature 3 (C16 : 1
 ω7c and/or C16 : 1
 ω6c) as major cellular fatty acids and menaquinone-6 as the major respiratory quinone. Phosphatidylethanolamine, two unidentified aminolipids and four unidentified lipids were detected as major polar lipids. The G+C content of the genomic DNA was 40.7 mol%. Phylogenetic analysis based on 16S rRNA gene sequences showed that strain MJ115T formed a phyletic lineage with

Nonlabens marinus

S1-08T,

Nonlabens agnitus

JC2678T and

Nonlabens antarcticus

AKS 622T within the genus

Nonlabens

. Strain MJ115T was also most closely related to

N. marinus

S1-08T,

N. agnitus

JC2678T and

N. antarcticus

AKS 622T with 96.5, 96.4 and 96.0 % 16S rRNA sequence similarities, respectively. Here it is proposed that strain MJ115T represents a new species of the genus

Nonlabens

, for which the name Nonlabens ponticola sp. nov. is proposed. The type strain is MJ115T (=KCTC 72237T=NBRC 113963T). In addition, the comparison of the whole genome sequences and phenotypic features suggested that

Nonlabens tegetincola

and

Nonlabens sediminis

belong to the same species. Therefore, it is proposed that

N. sediminis

is reclassified as a later heterotypic synonym of

N. tegetincola

.
ICTV Virus Taxonomy Profile: Ovaliviridae
Authors: Huang Li , Wang Haina ,   ICTV Report Consortium
Published: December 2020

Ovaliviridae is a family of enveloped viruses with a linear dsDNA genome. The virions are ellipsoidal, and contain a multi-layered spool-like capsid. The viral genome is presumably replicated through protein priming by a putative DNA polymerase encoded by the virus. Progeny virions are released through hexagonal openings resulting from the rupture of virus-associated pyramids formed on the surface of infected cells. The only known host is a hyperthermophilic archaeon of the genus

Sulfolobus

. This is a summary of the International Committee on Taxonomy of Viruses (ICTV) Report on the family Ovaliviridae, which is available at ictv.global/report/ovaliviridae.
The effect of osteotomy technique (flat-cut vs wedge-cut Weil) on pain relief and complication incidence following surgical treatment for patients presenting with metatarsalgia in a private metropolitan clinic: Protocol for a randomised controlled trial
Authors: Fatima Manaal , Ektas Nalan , Scholes Corey , Symes Michael , Wines Andrew
Published: December 2020

Introduction

Weil osteotomies are performed to surgically treat metatarsalgia, by shortening the metatarsal via either a single distal oblique cut (flat-cut) with translation of the metatarsal head, or through removal of a slice of bone (wedge-cut). The wedge-cut technique purportedly has functional and mechanical advantages over the flat-cut procedure, however in-vivo data and quality of evidence is currently lacking. This study aims to investigate whether wedge-cut Weil osteotomy compared to traditional flat-cut Weil is associated with increased pain relief and fewer complications up to 12 months postoperatively.

Methods and analysis

Patient, surgical and clinical data will be collected for 80 consecutive consenting patients electing to undergo surgical treatment of propulsive metatarsalgia in a randomised control trial, embedded within a clinical registry. The primary outcome is patient-reported pain as assessed by the Foot and Ankle Outcome Score (FAOS) - Pain subscale, and the secondary outcome is the incidence of procedure-specific complications at up to 12 months postoperatively. The groups will be randomised using a central computer-based simple randomisation system, with a 1:1 allocation without blocking and allocation concealment. A mixed-effects analysis of covariance will be used to assess the primary outcome, with confounders factored into the model. A binary logistic regression will be used to assess the secondary outcome in a multivariable model containing the same confounders.

Trial registration

Australian New Zealand Clinical Trials Registry, ACTRN12620001251910. Registered on 23 November 2020.

Ethics and dissemination

Ethics approval for this study was provided through the NSW/VIC branch of the Ramsay Health Care Human Research Ethics Committee (HREC approval number 2020-007). The results of this study will be disseminated through peer-reviewed journals and conference presentations.

Strengths and limitations of this study

To the best of the authors knowledge, the trial will be the first to examine clinical efficacy of the wedge-cut Weil osteotomy compared to the flat-cut technique with a prospective, randomised control design.

A sample size of N=80 participants will ensure adequate power to detect differences between the control and experimental groups, with an allowance for a dropout rate of 10%.

A limitation in the methods is the routine performance of adjunct surgical procedures for lesser toe or soft tissue correction. The statistical plan aims to control for this by treating adjunct procedures as potential confounders of the effect of the intervention, along with prognostic factors identified from available literature on pain ratings in metatarsalgia. These confounders will be included in the models used to analyse the primary and secondary outcomes.
Safety and immunogenicity trial of an inactivated SARS-CoV-2 vaccine-BBV152: a phase 1, double-blind, randomised control trial
Authors: Ella Raches , Mohan Krishna , Jogdand Harsh , Prasad Sai , Reddy Siddharth , Sarangi Vamshi Krishna , Ganneru Brunda , Sapkal Gajanan , Yadav Pragya , Panda Samiran , Gupta Nivedita , Reddy Prabhakar , Verma Savita , Rai Sanjay , Singh Chandramani , Redkar Sagar , Gillurkar Chandra Sekhar , Kushwaha Jitendra Singh , Rao Venkat , Mohapatra Satyajit , Guleria Randeep , Ella Krishna , Bhargava Balram
Published: December 2020

Background:
BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine formulated with a TLR 7/8 agonist molecule adsorbed to alum (Algel-IMDG).
Methods
We conducted a double-blind randomized controlled phase 1 clinical trial to evaluate the safety and immunogenicity of BBV152. A total of 375 participants were randomized equally to receive three vaccine formulations (n=100 each) prepared with 3 μg with Algel-IMDG, 6 μg with Algel-IMDG, and 6 μg with Algel, and an Algel only control arm (n=75). Vaccines were administered on a two-dose intramuscular accelerated schedule on day 0 (baseline) and day 14. The primary outcomes were reactogenicity and safety. The secondary outcomes were immunogenicity based on the anti-IgG S1 response (detected with an enzyme-linked immunosorbent assay [ELISA] and wild-type virus neutralization [microneutralization and plaque reduction neutralization assays]). Cell-mediated responses were also evaluated.
Results:
Reactogenicity was absent in the majority of participants, with mild events. The majority of adverse events were mild and were resolved. One serious adverse event was reported, which was found to be unrelated to vaccination. All three vaccine formulations resulted in robust immune responses comparable to a panel of convalescent serum. No significant differences were observed between the 3-μg and 6-μg Algel-IMDG groups. Neutralizing responses to homologous and heterologous SARS-CoV-2 strains were detected in all vaccinated individuals. Cell-mediated responses were biased to a Th-1 phenotype.
Conclusions
BBV152 induced binding and neutralising antibody responses and with the inclusion of the Algel-IMDG adjuvant, this is the first inactivated SARS-CoV-2 vaccine that has been reported to induce a Th1-biased response. Vaccine-induced neutralizing antibody titers were reported with two divergent SARS-CoV-2 strains. BBV152 is stored between 2°C and 8°C, which is compatible with all national immunization program cold chain requirements. Both Algel-IMDG formulations were selected for the phase 2 immunogenicity trials. Further efficacy trials are underway.
Analysis of PTRHD1 common and rare variants in European patients with Parkinson’s disease
Authors: Sosero Yuri L. , Bandres-Ciga Sara , Gan-Or Ziv , Krohn Lynne
Published: December 2020

Three family studies identified three different variants in the peptidyl-tRNA hydrolase domain containing 1 gene (PTRHD1) in patients affected by syndromic parkinsonism. In the current study, our objective was to investigate whether PTRHD1 variants are associated with Parkinson’s disease (PD) risk and age at onset (AAO). To evaluate the association between PTRHD1 and PD risk, we analyzed whole genome sequencing (WGS) data of 1,647 PD cases and 1,050 healthy controls, as well as genome-wide imputed genotyping data on 14,671 PD cases and 17,667 controls, all of European ancestry. Furthermore, we examined the association of PTRHD1 with PD risk and AAO using summary statistics data from the most recent PD genome-wide association study (GWAS) meta-analyses. Our results show no association between PTRHD1 and PD risk or AAO. We conclude that PTRHD1 does not play a major role in PD in the European population. Further large-scale studies including subjects with different ancestry and family trios might further clarify the relationship of this gene with PD and atypical parkinsonism.
Deep Learning Fusion for COVID-19 Diagnosis
Authors: Kechagias-Stamatis Odysseas , Aouf Nabil , Koukos John A.
Published: December 2020

The outbreak of the novel coronavirus (COVID-19) disease has spurred a tremendous research boost aiming at controlling it. Under this scope, deep learning techniques have received even more attention as an asset to automatically detect patients infected by COVID-19 and reduce the doctor’s burden to manually assess medical imagery. Thus, this work considers a deep learning architecture that fuses the layers of current-state-of-the-art deep networks to produce a new structure-fused deep network. The advantages of our deep network fusion scheme are multifold, and ultimately afford an appealing COVID-19 automatic diagnosis that outbalances current deep learning methods. Indeed, evaluation on Computer Tomography (CT) and X-ray imagery considering a two-class (COVID-19/ non-COVID-19) and a four-class (COVID-19/ non-COVID-19/ Pneumonia bacterial / Pneumonia virus) classification problem, highlights the classification capabilities of our method attaining 99.3% and 100%, respectively.
Modeling of aerosol transmission of airborne pathogens in ICU rooms of COVID-19 patients with acute respiratory failure
Authors: Crawford Cyril , Vanoli Emmanuel , Decorde Baptiste , Lancelot Maxime , Duprat Camille , Josserand Christophe , Jilesen Jonathan , Bouadma Lila , Timsit Jean-François
Published: December 2020

The COVID-19 pandemic has generated many concerns about cross-contamination risks, particularly in hospital settings and Intensive Care Units (ICU). Virus-laden aerosols produced by infected patients can propagate throughout ventilated rooms and put medical personnel entering them at risk. Experimental results found with a schlieren optical method have shown that the air flows generated by a cough and normal breathing were modified by the oxygenation technique used, especially when using High Flow Nasal Canulae, increasing the shedding of potentially infectious airborne particles. This study also uses a 3D Computational Fluid Dynamics model based on a Lattice Boltzmann Method to simulate the air flows as well as the movement of numerous airborne particles produced by a patient’s cough within an ICU room under negative pressure. The effects of different mitigation scenarii on the amount of aerosols potentially containing SARS-CoV-2 that are extracted through the ventilation system are investigated. Numerical results indicate that adequate bed orientation and additional air treatment unit positioning can increase by 40% the number of particles extracted and decrease by 25% the amount of particles deposited on surfaces 45s after shedding. This approach could help lay the grounds for a more comprehensive way to tackle contamination risks in hospitals, as the model can be seen as a proof of concept and be adapted to any room configuration.
Increased Burden of Familial-associated Early-onset Cancer Risk among Minority Americans Compared to non-Latino Whites
Authors: Feng Qianxi , Nickels Eric , Muskens Ivo S. , de Smith Adam J. , Gauderman W. James , Yee Amy C. , Ricker Charite , Mack Thomas , Leavitt Andrew D. , Godley Lucy A. , Wiemels Joseph L.
Published: December 2020

Background

The role of race/ethnicity in genetic predisposition of early-onset cancers can be estimated by comparing family-based cancer concordance rates among ethnic groups.

Methods

We used linked California health registries to evaluate the relative cancer risks for first degree relatives of patients diagnosed between ages 0-26, and the relative risks of developing distinct second primary malignancies (SPMs). From 1989-2015, we identified 29,631 cancer patients and 62,863 healthy family members. We calculated the standardized incident ratios (SIRs) of early-onset primary cancers diagnosed in proband siblings and mothers, as well as SPMs detected among early-onset patients. Analyses were stratified by self-identified race/ethnicity.

Results

Given probands with cancer, there were increased relative risks of any cancer for siblings and mothers [SIR=3.32;95% confidence interval (CI):2.85-3.85)] and of SPMs (SIR=7.27;95%CI:6.56-8.03). Higher relative risk of any cancer in siblings and mothers given a proband with solid cancer (P<0.05) was observed for both Latinos (SIR=4.98;95%CI:3.82-6.39) and for non-Latino Blacks (SIR=7.35;95%CI:3.36-13.95) compared to non-Latino White subjects (SIR=3.02;95%CI:2.12-4.16). For hematologic cancers, higher familial risk was evident for Asian/Pacific Islanders (SIR=7.56;95%CI:3.26-14.90) compared to non-Latino whites (SIR:2.69;95%CI:1.62-4.20).

Conclusions

The data support a need for increased attention to the genetics of early-onset cancer predisposition and environmental factors in race/ethnic minority families in the US.

Funding

This work was supported by the V Foundation for funding this work (Grant FP067172).

Key Messages

We identified 29 631 cancer patients and their 62 863 healthy family members in California from 1989 to 2015.

The risk of early-onset cancer in siblings and mothers was elevated by having a proband with cancer in the same family.

The relative risk of early-onset cancers given a proband with solid cancer was higher for Latinos and Blacks when compared to non-Latino Whites.
Efficacy and safety of tenofovir disoproxil fumarate (TDF) in hepatitis B virus (HBV) monoinfection: longitudinal analysis of a UK cohort
Authors: Wang Tingyan , Smith David A , Campbell Cori , Mokaya Jolynne , Freeman Oliver , Salih Hizni , McNaughton Anna L , Cripps Sarah , Várnai Kinga A , Noble Theresa , Woods Kerrie , Collier Jane , Jeffery Katie , Davies Jim , Barnes Eleanor , Matthews Philippa C
Published: December 2020

Aim

Current clinical recommendations suggest treating chronic hepatitis B virus (HBV) infection in a minority of cases, but more data are needed to determine the benefits and risks of Tenofovir disoproxil fumarate (TDF) therapy. We aimed to assess the impact of TDF on liver disease, and the risk of nephrotoxicity.

Method

We studied a longitudinal UK chronic HBV (CHB) cohort attending out-patient clinics between 2005 and 2018, analysing data for 206 ethnically diverse adults (60 on TDF, 146 untreated), with median follow-up 3.3±2.8 years.

Results

Patients prescribed TDF were older (39 vs. 35 years, p=0.004) with a male excess (63% vs. 47%, p=0.04) compared to untreated patients. Reflecting treatment eligibility criteria, at baseline, treated patients were more likely to have elevated ALT (p<0.001), higher HBV DNA viral load (VL) (p<0.001), and higher elastography scores (p=0.002), but with no difference in renal function (p=0.6). In the TDF group, VL declined significantly between baseline and subsequent time points (all p<0.0001) with VL suppressed in 94% at three years, while in the untreated group viraemia was unchanged from baseline. In the TDF group, ALT and elastography scores normalised during treatment and by three years were equivalent to those in the untreated group. Progression of liver fibrosis did not occur in the TDF group but arose in 7.4% of untreated patients, although this difference was non-significant. There was no significant difference in renal impairment during follow-up between two groups.

Conclusion

TDF may have long-term benefits for a wider pool of the CHB population.
The de novo FAIRification process of a registry for vascular anomalies
Authors: Groenen Karlijn H.J. , Jacobsen Annika , Kersloot Martijn G. , Vieira Bruna , van Enckevort Esther , Kaliyaperumal Rajaram , Arts Derk L. , ‘t Hoen Peter A.C. , Cornet Ronald , Roos Marco , Kool Leo Schultze
Published: December 2020

Background

Patient data registries that are FAIR - Findable, Accessible, Interoperable, and Reusable for humans and computers - facilitate research across multiple resources. This is particularly relevant to rare diseases, where data often are scarce and scattered. Specific research questions can be asked across FAIR rare disease registries and other FAIR resources without physically combining the data.

Results

We successfully developed and implemented a process of making a rare disease registry for vascular anomalies FAIR from its conception -de novo. Here, we describe the five phases of this process in detail: i) pre-FAIRification, ii) facilitating FAIRification, iii) data collection, iv) generating FAIR data in real-time, and v) using FAIR data. This includes the creation of an electronic case report form and a semantic data model of the “Set of Common Data Elements for Rare Disease Registration” released by the European Commission, and the technical implementation in the Electronic Data Capture (EDC) system for real-time, automatic data FAIRification. Further, we describe how we contribute to the four facets of FAIR, and how our FAIRification process can be reused by other registries.

Conclusions

In conclusion, a detailed de novo FAIRification process of a registry for vascular anomalies is described. To a large extent, the process may be reused by other rare disease registries, and we envision this work to be a substantial contribution to an ecosystem of FAIR rare disease resources.