bluuebunny/crossref_metadata_2025_split huggingface dataset:
Outcomes and outcome measures reported in clinical studies of therapeutic mammaplasty: a systematic review protocol
Authors: Lee Alice , Kwasnicki Richard M , Leff Daniel R 
Published: June 2021

IntroductionTherapeutic mammaplasty (TM) is an oncological procedure which combines tumour resection with breast reduction and mastopexy techniques. Previous systematic reviews have demonstrated oncological safety of TM, but poor and inconsistent reporting of quality-of-life, aesthetic and functional outcomes, often with non-validated measurement tools. Moreover, there is a paucity of patient-reported outcome measures. Standardisation of outcome reporting is required to enable study results to be compared and combined, for example, through core outcome set (COS) development. This systematic review aims to comprehensively describe the outcomes reported in clinical studies of TM, their respective outcome measures and the time points at which they were evaluated. The overall objective is to facilitate the development of a COS for TM.Methods and analysisA systematic review of clinical studies evaluating outcomes following TM will be completed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The following electronic databases have been searched from inception to 5 August 2020: Ovid MEDLINE, Embase, CINAHL and Web of Science. Primary outcomes will include the number of reported outcomes of various types (clinical, aesthetic, functional, quality-of-life and cost-effectiveness), whether these are patient-reported or clinician-reported, how outcomes are defined and the outcome measurement tool(s) used. The time point(s) at which outcomes were measured will be a secondary outcome. No studies will be excluded on the basis of methodological quality in order to generate a comprehensive list of reported outcomes and outcome measures; hence, risk of bias assessment is not required. The data will be described narratively. This protocol has been reported in line with PRISMA-Protocols.Ethics and disseminationThis study does not involve human or animal participants, hence ethical approval is not required. The findings will be published in a peer-reviewed journal and presented at relevant conferences.PROSPERO registration numberCRD42020200365.
Study protocol designed to investigate tumour response to calcium electroporation in cancers affecting the skin: a non-randomised phase II clinical trial
Authors: Vissing Mille , Ploen John , Pervan Mascha , Vestergaard Kitt , Schnefeldt Mazen , Frandsen Stine Krog , Rafaelsen Søren Rafael , Lindhardt Christina Louise , Jensen Lars Henrik , Rody Achim , Gehl Julie 
Published: June 2021

IntroductionSkin malignancy is a distressing problem for many patients, and clinical management is challenging. This article describes the protocol for the Calcium Electroporation Response Study (CaEP-R) designed to investigate tumour response to calcium electroporation and is a descriptive guide to calcium electroporation treatment of malignant tumours in the skin. Calcium electroporation is a local treatment that induces supraphysiological intracellular calcium levels by intratumoural calcium administration and application of electrical pulses. The pulses create transient membrane pores allowing diffusion of non-permeant calcium ions into target cells. High calcium levels can kill cancer cells, while normal cells can restore homeostasis. Prior trials with smaller cohorts have found calcium electroporation to be safe and efficient. This trial aims to include a larger multiregional cohort of patients with different cancer diagnoses and also to investigate treatment areas using MRI as well as assess impact on quality of life.Methods and analysisThis non-randomised phase II multicentre study will investigate response to calcium electroporation in 30 patients with cutaneous or subcutaneous malignancy. Enrolment of 10 patients is planned at three centres: Zealand University Hospital, University Hospital of Southern Denmark and University Hospital Schleswig-Holstein. Response after 2 months was chosen as the primary endpoint based on short-term response rates observed in a prior clinical study. Secondary endpoints include response to treatment using MRI and change in quality of life assessed by questionnaires and qualitative interviews.Ethics and disseminationThe trial is approved by the Danish Medicines Agency and The Danish Regional Committee on Health Research Ethics. All included patients will receive active treatment (calcium electroporation). Patients can continue systemic treatment during the study, and side effects are expected to be limited. Data will be published in a peer-reviewed journal and made available to the public.Trial registration numbersNCT04225767and EudraCT no: 2019-004314-34.
Challenges of developing, conducting, analysing and reporting a COVID-19 study as the COVID-19 pandemic unfolds: an online co-autoethnographic study
Authors: das Nair Roshan , Hunter Rachael , Garjani Afagh , Middleton Rod M , Tuite-Dalton Katherine A , Nicholas Richard S , Evangelou Nikos 
Published: June 2021

ObjectivesTo capture the complexities and unique experience of a newly formed multidisciplinary and multicentre research team developing and deploying a COVID-19 study and to identify lessons learnt.DesignCo-autoethnographic study.SettingStaff at two UK academic institutions, a national charity and two major UK hospitals.ParticipantsResearchers, clinicians, academics, statisticians and analysts, patient and public involvement representatives and national charity.MethodsThe sampling frame was any content discussed or shared between research team members (emails, meeting minutes, etc), standard observational dimensions and reflective interviews with team members. Data were thematically analysed.ResultsData from 34 meetings and >50 emails between 17 March and 5 August 2020 were analysed. The analysis yielded seven themes with ‘Managing our stress’ as an overarching theme.ConclusionsMutual respect, flexibility and genuine belief that team members are doing the best they can under the circumstances are essential for completing a time-consuming study, requiring a rapid response during a pandemic. Acknowledging and managing stress and a shared purpose can moderate many barriers, such as the lack of face-to-face interactions, leading to effective team working.
Superiority trial comparing intraoperative wound irrigation with aqueous 10% povidone–iodine to saline for the purpose of reducing surgical site infection after elective gastrointestinal surgery: study protocol for a randomised controlled trial
Authors: Maemoto Ryo , Noda Hiroshi , Ichida Kosuke , Tamaki Sawako , Kanemitsu Rina , Machida Erika , Kikuchi Nozomi , Sakio Ryotaro , Aizawa Hidetoshi , Fukui Taro , Kakizawa Nao , Muto Yuta , Iseki Masahiro , Fukuda Rintaro , Watanabe Fumiaki , Kato Takaharu , Saito Masaaki , Tsujinaka Shingo , Miyakura Yasuyuki , Rikiyama Toshiki 
Published: June 2021

IntroductionSurgical site infection (SSI) is one of the most common complications after gastrointestinal surgery, with a reported incidence of approximately 10%–25%, which is higher than the rates after other types of surgery. Intraoperative wound irrigation (IOWI) is a simple intervention for SSI prevention, and recent studies have reported that IOWI with aqueous povidone–iodine (PVP-I) is significantly more effective at reducing the incidence of SSI than saline. However, the evidence level of previous trials evaluating the efficacy of aqueous PVP-I solution for preventing SSI has been low.Methods and analysesWe propose a single-institute, prospective, randomised, blinded-endpoint trial to assess the superiority of IOWI with aqueous 10% PVP-I solution compared with normal saline for reducing SSI in clean-contaminated wounds after elective gastrointestinal surgery. In the study group, IOWI with 40 mL of aqueous 10% PVP-I solution is performed for 1 min before skin suture, and in the control group, IOWI with 100 mL of saline is performed for 1 min before skin suture. We hypothesise that IOWI with aqueous 10% PVP-I solution will achieve a 50% reduction in the incidence of SSIs. The target number of cases is set at 950. The primary outcome is the incidence of incisional SSI up to postoperative day 30 and will be analysed in the modified intention-to-treat set.Ethics and disseminationThis trial was designed and is being conducted by Saitama Medical Center, Jichi Medical University, with approval from the Bioethics Committee for Clinical Research, Saitama Medical Center, Jichi Medical University. Participant recruitment began in June 2019. The final results will be reported in international peer-reviewed journals immediately after trial completion.Trial registration numberUMIN000036889.
High-fidelity simulation and virtual reality: an evaluation of medical students’ experiences
Authors: Macnamara Alexandra Frances , Bird Katie , Rigby Alan , Sathyapalan Thozhukat , Hepburn David 
Published: June 2021

BackgroundSimulation technology is widely used in medical education, providing an environment in which students can develop and practise a multitude of skills that are relevant to clinical practice, without the risk of harm to patients.MethodsWe conducted a mixed methods cross-over study with quantitative and qualitative outcomes. This analysed students’ perceptions of two simulation technologies: a high-fidelity patient simulator and virtual reality. Twenty final year medical students completed a questionnaire after having experienced both simulation modalities.ResultsStudents scored the patient simulator higher in domains such as developing team working and ‘ABCDE assessment skills’, whereas the virtual reality simulation was more immersive and fun. Participants found the patient simulator more useful in preparing them for clinical practice.ConclusionMedical students in this study expressed that a high-fidelity patient simulator, in a simulated clinical environment, was of greater value to their preparation for clinical practice than virtual reality simulation of a similar environment. However, the virtual reality simulation offered a near comparable experience, and was found to be was enjoyable, immersive and easily portable.
Effects of dietary patterns on driving behaviours among professional truck drivers: the mediating effect of fatigue
Authors: Ge Yan , He Shanshan , Xu Yan , Qu Weina 
Published: June 2021

ObjectiveTo explore the impact of the dietary patterns of truck drivers on their driving behaviours and the mediation effect of fatigue between these factors.MethodsA sample of 389 male truck drivers from a transport company in Suzhou, China completed the Food Frequency Questionnaire (FFQ), the Multidimensional Fatigue Inventory (MFI), the Positive Driver Behaviours Scale (PDBS) and the Driver Behaviour Questionnaire (DBQ). The associations among dietary patterns, fatigue and driving behaviour were examined using pathway analysis.ResultsFour dietary patterns were identified based on principal component analysis: animal-derived foods, staple foods, snacks and vegetables. The pathway analysis showed that the vegetable-rich pattern had a direct positive impact on positive driving behaviour (β=0.211, p<0.001); the animal-derived pattern had a direct positive impact on errors (β=0.094, p<0.05) and ordinary violations (β=0.071, p<0.05); the snacks pattern had a direct negative impact on positive driving behaviour (β=−0.191, p<0.001); fatigue mediated the effect of dietary patterns on driving behaviours (p<0.001); and the staple foods had an indirect effect on driving behaviours.ConclusionsOverall, the driving behaviours of truck drivers are correlated with their dietary patterns. Drivers who preferred vegetables and staple foods had more positive driving behaviour, while the animal-derived food and snack patterns were related to dangerous driving behaviour. The experience of fatigue could explained the underlying mechanism between these factors.
Association of HLA-B Gene Polymorphisms with Type 2 Diabetes in Pashtun Ethnic Population of Khyber Pakhtunkhwa, Pakistan
Authors: Jan Asif , Saeed Muhammad , Afridi Muhammad Hussain , Khuda Fazli , Shabbir Muhammad , Khan Hamayun , Ali Sajid , Hassan Muhammad , Samiullah  , Akbar Rani , Zakiullah  
Published: June 2021

Human leukocyte antigen (HLA) system is the most polymorphic and gene dense region of human DNA that has shown many disease associations. It has been further divided into HLA classes I, II, and III. Polymorphism in HLA class II genes has been reported to play an important role in the pathogenesis of type 1 diabetes (T1D). It also showed association with T2D in different ethnic populations. However, a little is known about the relationship of HLA class I gene polymorphism and T2D. This study has evaluated the association of HLA-B (class I gene) variants with T2D in Pashtun ethnic population of Khyber Pakhtunkhwa. In the first phase of the study, whole exome sequencing (WES) of 2 pooled DNA samples was carried out, and DNA pools used were constructed from 100 diabetic cases and 100 control subjects. WES results identified a total of

n
=
17

SNPs in HLA-B gene. In the next phase, first 5 out of

n
=
17

reported SNPs were genotyped using MassARRAY® system in order to validate WES results and to confirm association of selected SNPs with T2D. Minor allele frequencies (MAFs) and selected SNPs×T2D association were determined using chi-square test and logistic regression analysis. The frequency of minor C allele was significantly higher in the T2D group as compared to control group (45.0% vs. 13.0%) (

p
=
0.006

) for rs2308655 in HLA-B gene. No significant difference in MAF distribution between cases and controls was observed for rs1051488, rs1131500, rs1050341, and rs1131285 (

p
>
0.05

). Binary logistic regression analyses showed significant results for SNP rs2308655 (

OR
=
2.233

,

CI

95
%

=
1.223
‐
4.077

, and

p
=
0.009

), while no considerable association was observed for the other 4 SNPs. However, when adjusted for these variants, the association of rs2308655 further strengthened significantly (

adjusted

OR
=
7.485

,

CI

95
%

=
2.353
‐
23.812

, and

p
=
0.001

), except for rs1131500, which has no additive effect. In conclusion, the finding of this study suggests rs2308655 variant in HLA-B gene as risk variant for T2D susceptibility in Pashtun population.
Determinants of Use of Traditional Birth Services in Communities Inclined to Use Them in Nigeria and Ghana
Authors: Olutegbe Nathaniel Siji , Bartimeus Harry Aryeh 
Published: June 2021

Abstract
Several programmes by government and non-governmental organisations aimed at improving maternal health in many sub-Saharan African nations have not achieved significant results. Use of traditional maternal care services has been identified as still prevalent and thus a possible factor. This study investigated determinants of use of traditional birth services (tbs s) among patrons in tbs-inclined communities of Nigeria and Ghana. A total of 180 and 160 patrons of tbs s were selected from the respective countries, using a multi-stage procedure. The most utilised tbs s include home delivery, concoctions/herbs and family planning. Educational level, constraints to using conventional services, income, and perceived social and economic advantages significantly influenced utilisation. Patrons in Nigeria had better perceived relative advantages of tbs than Ghana, while the accessibility of conventional maternal services, performance rating and overall utilisation of tbs s did not differ significantly between the two countries. Social bonds and economic status were the main reasons for continued patronage of tbs s.
To Medicalise or Not to Medicalise: Is that the Question?
Authors: Van Eekert Nina 
Published: June 2021

Abstract
Today, female genital cutting (fgc) is more often performed by health professionals. In this dissertation we aim to answer the question of why mothers opt to medicalise their daughters’ cut, and how this decision relates to their social position within their community. We focus on Egypt and Kenya.
The first important conclusion of our research is that increasing medicalisation and decreasing fgc prevalence can coexist. Moreover, we identify three major drivers behind mothers’ choice to medicalise their daughters’ cut. Firstly, mothers argue that they opt for a medicalised cut to reduce the health risks related to the cut. They seek a less harmful but still culturally acceptable alternative. Secondly, the medicalisation of fgc is socially stratified. Thirdly, medicalisation may act as a social norm in itself.
In conclusion, we state that the debate about medicalisation should be more nuanced and that the general discourse on medicalisation should be challenged and empirically grounded.
Taxonomic review of the genus Assamacris (Orthoptera: Acrididae: Catantopinae) with a new species and a newly discovered female
Authors: MAO BEN-YONG , NIU YAO , HUANG JIAN-HUA 
Published: June 2021

Taxonomic review of the genus Assamacris Uvarov, 1942 is given. The genus Traulitonkinacris You & Bi, 1983 is synonymized with Assamacris. Traulitonkinacris bifurcatus You & Bi, 1983 is transferred to Assamacris as a new combination. Assamacris splendida sp. nov. is described as new species. A newly discovered female of A. curticerca (Huang, 1981) is introduced. A key to the species is updated.
Downregulated luteolytic pathways in the transcriptome of early pregnancy bovine corpus luteum are mimicked by interferon-tau in vitro
Authors: Basavaraja Raghavendra , Drum Jessica N. , Sapuleni Jackson , Bibi Lonice , Friedlander Gilgi , Kumar Sai , Sartori Roberto , Meidan Rina 
Published: June 2021

Abstract
Background
Maintenance of the corpus luteum (CL) beyond the time of luteolysis is essential for establishing pregnancy. Identifying the distinct features of early pregnancy CL remains unresolved, hence we analyzed here the transcriptome of CL on day 18 pregnant (P) and non-pregnant (NP) cows using RNA-Seq. CL of P cows expressed ISGs, verifying exposure to the pregnancy recognition signal, interferon-tau (IFNT), whereas the CL of NP cows had elevated luteal progesterone levels, implying that luteolysis had not yet commenced.

Results
The DEGs, IPA, and metascape canonical pathways, along with GSEA analysis, differed markedly in the CL of P cows from those of NP cows, at the same day of the cycle. Both metascape and IPA identified similar significantly enriched pathways such as interferon alpha/beta, sonic hedgehog pathway, TNFA, EDN1, TGFB1, and PDGF. However, type-1 interferon and sonic hedgehog pathways were positively enriched whereas most of the enriched pathways were downregulated in the P compared to NP samples. Thirty-four % of these pathways are known to be elevated by PGF2A during luteolysis. Notably, selective DEGs in luteinized granulosa cells were modulated by IFNT in vitro in a similar manner to their regulation in the CL of P cows.

Conclusion
This study unraveled the unique transcriptomic signature of the IFNT-exposed, early pregnancy CL, highlighting the abundance of downregulated pathways known to be otherwise induced during luteolysis. These and IFNT-regulated in vitro pregnancy-specific DEGs suggest that IFNT contributes to the characteristics and maintenance of early pregnancy CL.
Implications of ACMG guidelines to identify high-risk acute lymphoblastic leukemia patients with hereditary cancer susceptibility syndromes (HCSS) in a highly consanguineous population
Authors: Aslam Sara , Shabana  , Ahmed Mehboob 
Published: June 2021

Abstract
Background
Hereditary cancer susceptibility syndrome (HCSS) contributes to the cancer predisposition at an early age, therefore, identification of HCSS has found to be crucial for surveillance, managing therapeutic interventions and refer the patients and their families for genetic counselling. The study aimed to identify ALL patients who meet the American College of Medical Genetics (ACMG) criteria and refer them for the genetic testing for HCSS as hereditary leukemia and hematologic malignancy syndrome, and to elucidate the significance of high consanguinity with the prevalence of inherited leukemia in Pakistani population.

Methods
A total of 300 acute lymphoblastic leukemia patients were recruited from the Children’s Hospital, Lahore, Pakistan from December 2018 to September 2019. A structured self-reporting questionnaire based on family and medical history of the disease was utilized for the data collection.

Results
In our cohort, 60.40% of ALL patients were identified to meet ACMG criteria. Among them, a large number of patients (40.65%) solely fulfil the criteria due to the presence of parental consanguinity. However, parental consanguinity showed protective impact on the onset at early age of disease [OD = 0.44 (0.25–0.77), p-value = 0.00] while, a family history of cancer increased the risk of cardiotoxicity [OD = 2.46 (1.15–5.24), p-value = 0.02]. Parental consanguinity shows no significant impact on the family history of cancer and the number of relatives with cancer.

Conclusions
More than 50% of the ALL patients were considered the strong candidates’ for genetic testing of HCSS in the Pakistani population, and parental consanguinity was the leading criteria fulfilled by the individuals when assessed through ACMG guidelines. Our study suggests revisiting ACMG guidelines, especially for the criterion of parental consanguinity, and formulating the score based criteria based on; genetic research, the toxicology profile, physical features, personal and family history of cancer for the identification of patients for the genetic testing.