bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety and Immunogenicity of ChAd63/MVA Pfs25-IMX313 in a Phase I First-in-Human Trial
Authors: de Graaf Hans , Payne Ruth O. , Taylor Iona , Miura Kazutoyo , Long Carol A. , Elias Sean C. , Zaric Marija , Minassian Angela M. , Silk Sarah E. , Li Lee , Poulton Ian D. , Baker Megan , Draper Simon J. , Gbesemete Diane , Brendish Nathan J. , Martins Filipa , Marini Arianna , Mekhaiel David , Edwards Nick J. , Roberts Rachel , Vekemans Johan , Moyle Sarah , Faust Saul N. , Berrie Eleanor , Lawrie Alison M. , Hill Fergal , Hill Adrian V. S. , Biswas Sumi 
Published: July 2021

BackgroundTransmission blocking vaccines targeting the sexual-stages of the malaria parasite could play a major role to achieve elimination and eradication of malaria. The Plasmodium falciparum Pfs25 protein (Pfs25) is the most clinically advanced candidate sexual-stage antigen. IMX313, a complement inhibitor C4b-binding protein that forms heptamers with the antigen fused to it, improve antibody responses. This is the first time that viral vectors have been used to induce antibodies in humans against an antigen that is expressed only in the mosquito vector.MethodsClinical trial looking at safety and immunogenicity of two recombinant viral vectored vaccines encoding Pfs25-IMX313 in healthy malaria-naive adults. Replication-deficient chimpanzee adenovirus serotype 63 (ChAd63) and the attenuated orthopoxvirus modified vaccinia virus Ankara (MVA), encoding Pfs25-IMX313, were delivered by the intramuscular route in a heterologous prime-boost regimen using an 8-week interval. Safety data and samples for immunogenicity assays were taken at various time-points.ResultsThe reactogenicity of the vaccines was similar to that seen in previous trials using the same viral vectors encoding other antigens. The vaccines were immunogenic and induced both antibody and T cell responses against Pfs25, but significant transmission reducing activity (TRA) was not observed in most volunteers by standard membrane feeding assay.ConclusionBoth vaccines were well tolerated and demonstrated a favorable safety profile in malaria-naive adults. However, the transmission reducing activity of the antibodies generated were weak, suggesting the need for an alternative vaccine formulation.Trial RegistrationClinicaltrials.gov NCT02532049.
Peritoneal Protein Loss Is Not Associated With Sarcopenia in Peritoneal Dialysis Patients
Authors: Do Jun Young , Kim A Young , Kang Seok Hui 
Published: July 2021

Introduction: Maintenance of a peritoneal membrane is essential for maintaining long-term peritoneal dialysis (PD). Peritoneal protein loss (PPL) is basically the loss of an essential nutrient, which may lead to malnutrition. We aimed to evaluate the association between PPL and sarcopenia in PD patients.Methods: We conducted a cross-sectional study from September 2017 to November 2020 on all PD patients (n = 199). Finally, the patients were divided into tertiles based on the PPL level as follows: low, middle, and high. PPL (mg/day), appendicular lean mass (ALM) using dual-energy X-ray absorptiometry, and handgrip strength (HGS) were evaluated. Sarcopenia was defined using cut-off values from the Asian Working Group for Sarcopenia.Results: The median PPL (interquartile range, interval) in the low, middle, and high tertiles were 4,229 (904, 1,706–5,111), 6,160 (760, 5,118–7,119), and 8,543 (2,284, 7,145–24,406) mg/day, respectively. HGS in the low, middle, and high tertiles was 23.4 ± 9.2, 23.8 ± 8.9, and 23.6 ± 8.3 kg, respectively (P = 0.967). The ALM index in the low, middle, and high tertiles was 6.0 ± 1.3, 6.0 ± 1.2, and 6.5 ± 1.1 kg/m2, respectively (P = 0.061). Multivariate analyses did not reveal significant differences in HGS and ALM index in among tertiles. The proportions of patients with sarcopenia in the low, middle, and high tertiles was 24 (36.4%), 19 (28.4%), and 21 (31.8%), respectively (P = 0.612).Conclusion: The present study showed that PPL is not independently associated with muscle mass, strength, and sarcopenia in PD patients.
Invisible and Flexible Printed Sensors Based on ITO Nanoparticle Ink for Security Applications
Authors: Gilshtein Evgeniia , Tacneng Jasmine , Bolat Sami , Torres Sevilla Galo , Romanyuk Yaroslav E. 
Published: July 2021

Here, we propose a method to create a transparent security system based on printed conductive indium tin oxide (ITO)—the most widely used transparent conducting oxide material integrated into the devices with high transparency. Commonly used solution-processed ITO annealing methods are utilizing temperatures which are limiting the use of flexible polymeric substrates. Our method combines inkjet printing on flexible temperature-stable colorless polyimide (CPI) substrate with fast flash lamp annealing (FLA). In this study, millisecond pulses of visible light from a xenon lamp induce rapid heating of the ITO films up to 650°C through the light-absorbing additional layer of a colored organic dye onto printed ITO, whereas the CPI bulk never exceeds the melting point. Fabricated flexible ITO patterns on CPI film processed with the flash lamp annealing through the dye layer exhibit a transmittance of up to 85% at the wavelength of 550 nm and sheet resistance of 520 Ω/sq for a 70 nm layer thickness. With the proposed technology of our demonstrator realization—transparent glass/window or any other object such as a curved door lock can be used for integrating a touch-enabled transparent security access system, which would be completely invisible.
Consideration of Surrogate Endpoints for Overall Survival Associated With First-Line Immunotherapy in Extensive-Stage Small Cell Lung Cancer
Authors: Zhang Shuang , Li Shuang , Cui Yanan , Zhao Peiyan , Sun Xiaodan , Cheng Ying 
Published: July 2021

BackgroundThe combination of immune checkpoint inhibitors (ICIs) and chemotherapy is known to improve overall survival (OS) in patients with extensive-stage small cell lung cancer (ES-SCLC). ICIs have different response patterns and survival kinetics characteristics from those of the traditional chemotherapy. In first-line treatment for ES-SCLC, there is an urgent need for surrogate endpoints for the early and accurate prediction of OS. This study aimed to assess progression-free survival (PFS), milestone OS rate, milestone restricted mean survival time (RMST), overall response rate (ORR), and disease control rate (DCR) as proposed surrogate endpoints for OS in ES-SCLC for first-line immunotherapy trials.MethodsBetween January 1, 2013, and December 2020, published articles on randomized clinical trials of ICIs plus chemotherapy in patients with ES-SCLC as first-line therapy were searched in PubMed. Abstracts from the ESMO, ASCO, and WCLC, reported from 2018 onwards, were also searched. A weighted regression analysis based on the weighted least squares method was performed on log-transformed estimates of treatment effect, and the determination coefficient (R2) was calculated to evaluate the association between treatment effect on the surrogate endpoint and OS.ResultsSeven trials, representing 3,009 patients, were included to make up a total of 16 analyzed arms. The ratio of the 12-month OS milestone rate (r = −0.790, P = 0.011, R2 = 0.717) and 12-month OS milestone RMST (r = 0.798, P = 0.010, R2 = 0.702) was strongly correlated with the hazard ratio (HR) for OS. The strongest association was observed between the ratio of the 24-month OS milestone RMST and the HR for OS (r = 0.922, P = 0.001, R2 = 0.825). No associations were observed between the HR for OS and PFS and the RR for ORR and DCR.ConclusionsThe results suggested a strong correlation among the ratio of OS milestone rates at 12 months, ratios of OS milestone RMSTs at 12 and 24 months, and HR for OS. The results indicate that OS milestone rates and OS milestone RMSTs could be considered surrogate endpoints of OS in future first-line immunotherapy trials for ES-SCLC.
ER-α36 Promotes the Malignant Progression of Cervical Cancer Mediated by Estrogen via HMGA2
Authors: Wang Chunyan , Zhang Tianli , Wang Kun , Zhang Shuo , Sun Qing , Yang Xingsheng 
Published: July 2021

ObjectivesEstrogen is proven to promote the malignant behaviors of many cancers via its receptors. Estrogen receptor alfa 36 (ER-α36) is a newly identified isoform of estrogen receptor alfa (ER-α), the role of ER-α36 in regulating the effects of estrogen and its potential impact on human cervical cancer is poorly understood.MethodsImmunohistochemistry staining was used to evaluate the expression of ER-α36, estrogen receptor alfa 66 (ER-α66) and their prognostic values in cervical cancer. The effects of ER-α36 and ER-α66 on the proliferation and metastasis of cervical cancer were measured in vitro. A xenograft tumor assay was used to study the tumorigenesis role of ER-α36 in vivo. Furthermore, the functional gene at the downstream of ER-α36 was obtained via next-generation sequencing, and the biological functions of high mobility group A2 (HMGA2) in cervical cancer cells were investigated in vitro.ResultsER-α36 was over-expressed in cervical cancer tissues and elevated ER-α36 expression was associated with poor prognosis in cervical cancer patients. High expression of ER-α36 promoted the proliferation, invasion and metastasis of cervical cancer cells mediated by estrogen, while silencing ER-α36 had the opposite effects. Further research showed that HMGA2 was a downstream target of ER-α36 in cervical cancer cells. The oncogenic effect of ER-α36 was attenuated after HMGA2 knockdown.ConclusionsHigh expression of ER-α36 was correlated with a poor prognosis in cervical cancer by regulating HMGA2. ER-α36 could be a prognostic biomarker and a target for cervical cancer treatment.
Identification of the Prognosis Value and Potential Mechanism of Immune Checkpoints in Renal Clear Cell Carcinoma Microenvironment
Authors: Liao Guodong , Wang Ping , Wang Yuyong 
Published: July 2021

BackgroundKidney Renal Clear Cell Carcinoma (KIRC) is one of the most prevalent types of cancer worldwide. KIRC has a poor prognosis and, to date, immunotherapy based on immune checkpoints is the most promising treatment. However, the role of immune checkpoints in KIRC remains ambiguous.MethodsBioinformatics analyses and qRT-PCR were performed to explore and further confirm the prognostic value of immune checkpoint genes and their correlation with immune infiltration in KIRC samples.ResultsThe expression of the immune checkpoint genes CD274, PDCD1LG2, HAVCR2, CTLA4, TIGFT, LAG3, and PDCD1 was upregulated in KIRC tissues. These genes were involved in the activation of the apoptosis pathway in KIRC. Low expression of CD274 and HAVCR2 and high expression of CTLA4 were associated with poor overall survival (OS), progression-free survival (PFS), and disease-free survival (DFS) of KIRC patients. The univariate and multivariate analyses revealed that CTLA4, HAVCR2, age, pTNM stage, and tumor grade were independent factors affecting the prognosis of KIRC patients. A predictive nomogram demonstrated that the calibration plots for the 3‐year and 5‐year OS probabilities showed good agreement compared to the actual OS of KIRC patients. The expression of CTLA4 and HAVCR2 were positively associated with immune cell infiltration, immune biomarkers, chemokines, and chemokine receptors. Moreover, miR-20b-5p was identified as a potential miRNA target of CTLA4 in KIRC.ConclusionOur study clarified the prognostic value of several immune checkpoint regulators in KIRC, revealing a CTLA4/miR-20b-5p axis in the control of immune cell infiltration in the tumor microenvironment.
Knowledge Mobilized in Teacher–Student Interactions in PE in Difficult Vocational High School Classes: Enacted Knowledge
Authors: Girard Amélina , Vors Olivier 
Published: July 2021

Introduction: Our study aims to analyze the enactive knowledge mobilized during teacher–student interactions in physical education lessons with difficult classes in vocational high school. These classes are considered “difficult” because they concentrate a large number of pupils who are referred to them because they have no choice. This lack of choice makes it difficult for these pupils to engage in school work and is the cause of deviant behavior and school dropout.Methods: This study was conducted within the methodological and theoretical research program of the course of action. We analyzed the individual activity of nine teachers and 18 students during a PE lesson by collecting audiovisual data and conducting self-confrontation interviews. These data were processed in several stages: transcription, identification, and typification of the components of the experience.Results: The results show mutual active knowledge between the teacher and the “difficult” students: emerging from the context, anchored in a dynamic of experience, coupled with the concerns of actors. The teacher classifies the profiles of students according to their reaction to authority and their difficulties, by spotting students' “thermometers” of the class climate. Some of the knowledge of students is coupled with their concerns to avoid boredom, to avoid trouble with the teacher, and to avoid trouble with their friends.
Long Term Exercise Engagement of Adults Living With Type Two Diabetes Is Enhanced by a Person-Centred Care Approach Delivered by Knowledgeable, Well Trained Health Care Professionals
Authors: Hale Leigh , Higgs Christopher , Keen Donna , Smith Catherine 
Published: July 2021

Background: Regular engagement in exercise or physical activity is a key evidence-based recommendation in the self-management of type 2 diabetes (T2D). The Diabetes Community Exercise Programme (DCEP) is an exercise and educational programme aimed at supporting adults living with T2D to take control of their health and to live well with T2D. It was specifically developed to enhance the self-efficacy of people to engage in exercise for a long term and is underpinned by the spirit of motivational interviewing. This study explores what DCEP attendees and health care professionals (HCPs) who deliver the programme perceived DCEP to be and what motivated attendance. Such insights further the knowledge of how people with T2D can be supported to engage in exercise or physical activity programmes.Method: This qualitative study used open-ended interviews of 17 DCEP attendees and 12 HCPs delivering DCEP. Interviews occurred at the completion of the initial twice-a-week, 12-week duration part of the programme and prior to attendees starting with a twice-weekly maintenance exercise class, which forms the second part of the programme. Interviews were audio-recorded, transcribed verbatim and analysed with the General Inductive Approach.Results: The two themes constructed from the analysis were person-centred care and attention to logistics and administration. Person-centred care comprised four subthemes: monitoring, individualised exercise within a sociable group setting, flexible education and discussion, and HCP training, and these components appeared to support attendees to engage in exercise. The second theme spoke about the processes, that was either present or that should be included, that enabled DCEP delivery, such as appropriate venues, flexible approaches to time of day and the requirement of good administrative support.Conclusion: The Diabetes Community Exercise Programme did motivate people with T2D to engage in exercise. Important to this was the emphasis on a person-centred approach that focussed on the health status monitoring and educational and social aspects of the programme, which in turn facilitated exercise engagement. Knowledgeable HCPs who require training in the delivery of person-centred care to tailor the exercise and education to the individual is imperative. Equally important are optimal exercise environments and well-trained administrative support.
Development of a Methodological Quality Criteria List for Observational Studies: The Observational Study Quality Evaluation
Authors: Drukker Marjan , Weltens Irene , van Hooijdonk Carmen F. M. , Vandenberk Emma , Bak Maarten 
Published: July 2021

Background: Existing study quality and risk of bias lists for observational studies have important disadvantages. For this reason, a comprehensive widely applicable quality assessment tool for observational studies was developed.Methods: Criteria from three quality lists were merged into a new quality assessment tool: the observational study quality evaluation (OSQE). OSQE consists of a cohort, case–control, and cross-sectional version.Results: The OSQE cohort, the OSQE case–control, and the OSQE cross-sectional version include all items applicable to that type of study, for example, the representativeness of the study population, the validity of the independent and dependent variables, and the statistical methods used. Before scoring the OSQE, the rater is asked to define how to score items, in detail. A study can obtain a star for each item. Each item also has a veto cell. This cell can be checked when poor quality with respect to that specific item results in a low quality of the study despite stars on other items. Although stars add to a sum score, the comment field is the most important part of the OSQE.Conclusion: The OSQE presented in the current article provides a short, comprehensive, and widely applicable list to assess study quality and therewith risk of bias.
Finite Element Analysis of the Microwave Ablation Method for Enhanced Lung Cancer Treatment
Authors: Radmilović-Radjenović Marija , Sabo Martin , Prnova Marta , Šoltes Lukaš , Radjenović Branislav 
Published: July 2021

Knowledge of the frequency dependence of the dielectric properties of the lung tissues and temperature profiles are essential characteristics associated with the effective performance of microwave ablation. In microwave ablation, the electromagnetic wave propagates into the biological tissue, resulting in energy absorption and providing the destruction of cancer cells without damaging the healthy tissue. As a consequence of the respiratory movement of the lungs, however, the accurate prediction of the microwave ablation zone has become an exceptionally demanding task. For that purpose, numerical modeling remains a primordial tool for carrying out a parametric study, evaluating the importance of the inherent phenomena, and leading to better optimization of the medical procedure. This paper reports on simulation studies on the effect of the breathing process on power dissipation, temperature distribution, the fraction of damage, and the specific absorption rate during microwave ablation. The simulation results obtained from the relative permittivity and conductivity for inflated and deflated lungs are compared with those obtained regardless of respiration. It is shown that differences in the dielectric properties of inflated and deflated lungs significantly affect the time evolution of the temperature and its maximum value, the time, the fraction of damage, and the specific absorption rate. The fraction of damage determined from the degree of tissue injury reveals that the microwave ablation zone is significantly larger under dynamic physical parameters. At the end of expiration, the ablation lesion area is more concentrated around the tip and slot of the antenna, and the backward heating effect is smaller. The diffuse increase in temperature should reach a certain level to destroy cancer cells without damaging the surrounding tissue. The obtained results can be used as a guideline for determining the optimal conditions to improve the overall success of microwave ablation.
Faktor yang Mempengaruhi Struktur Modal pada Perusahaan Makanan dan Minuman Tbk
Authors: Arnita Vina , Nasution Nina Andriany , Murnihati Murnihati 
Published: July 2021

The research aims to analyze the influence of the investment opportunity set, profitability and operating leverage on the capital structureof food and beverage companies listed on the Indonesian Stock Exchange for the 2014-2018 period. Determination of samples using purposive sampling with criteria namely food and beverage companies listed on the Indonesian Stock Exchange and those who publish financial statements in a row during the 2014-2018 period, obtained 10 companies that meet the criteria and 5 years of observation to produce 50 samples. The results of the study indicate that the investment opportunity set variable in a negative and not significant effect on capital structure with a significance value of 0,129> 0,05, profitability in a positive and significant effect on capital structure with a significane value of 0,031< 0,05 and operating laverage in a prsial positive and significant effect on capital structure with a significance value of 0,030< 0,05. Investment opportunity set, profitability and operating laverage simultaneously influence the capital structure with a significance value of 0,049 > 0,05. Investment opportunity set, profitability and operating laverage are able to explain the capital structure of 10,5% is expalined by other factors not included in this study.
Perceraian di Kabupaten Rembang
Authors: Larasati Erinda , Nurhadi Nurhadi , Yuhastina Yuhastina 
Published: July 2021

Divorce research in Rembang Regency, Central Java aims to explore the study of bickering factors that can be a way of ending a marital relationship. The method used is a combination of quantitative and qualitative. Quantitative data obtained through surveys with purposive sampling techniques. Researchers selected 30 divorced people as respondents. Qualitative data was obtained through in-depth interviews with 10 potential participants. Qualitative data is analyzed using Spradley's domain model, which provides an overview of and thoroughly of the research object. The data obtained through surveys and interviews is subsequently converted into a script in order to obtain an overview of the objects studied. The study concluded that the factors that cause quarrels in the family are (1) the inability to support the family; (2) infidelity; (3) Domestic Violence; (4) misunderstanding; and (5) mismatch with a partner due to matchmaking practice.
Eksistensi Penganut Agama Parmalim Dalam Negara Demokrasi Indonesia
Authors: Nainggolan Mangido 
Published: July 2021

Every belief system are strongly influenced by culture, owned by adherents of that belief. North Sumatra is one of the areas in Indonesia who uphold the values of democracy which has been formulated in Pancasila and the 1945 Constitution. Parmalim religion group is a movement of spiritual exercises that move to defend and uphold the values and custom of the ancient belief are endangered. This spiritual movemen develoved in batak lands at once became a political movement that unifies batak to oppose the Netherlands 1883 or seven year before death Sisingamangaraja XII. Its diversity of tribes and religions in Indonesia should be made into a pride and wealth of is priceless because it is part of the identity of the nation itself. The diversity of it would be so wonderful if it cansoexist with mutual respect, appreciate and uphold the values of unity, mutual respect and mutual building to manifest prosperity together, the presence of adherents tend to beabused and Parmalim marginalized should be eliminated as the embodiment and the recognition of Human Right as well as the preservation of the values of Pancasila in accordance with the constitution..