bluuebunny/crossref_metadata_2025_split huggingface dataset:
Internal exposure risk due to radiocesium and the consuming behaviour of local foodstuffs among pregnant women in Minamisoma City near the Fukushima nuclear power plant: a retrospective observational study
Authors: Yamamoto Kana , Nomura Shuhei , Tsubokura Masaharu , Murakami Michio , Ozaki Akihiko , Leppold Claire , Sawano Toyoaki , Takita Morihito , Kato Shigeaki , Kanazawa Yukio , Anbe Hiroshi 
Published: July 2019

ObjectivesThis study aimed to evaluate the internal cesium (Cs) level among pregnant women in Minamisoma City (the area straddling the evacuation zones) over a 5-year period after Japan’s 2011 Fukushima nuclear accident and assess the status and transition of their food-acquiring preferences during this period.DesignA retrospective observational study of a screening along with a questionnaire survey.SettingThis study was conducted in an obstetrics and gynaecology service in Minamisoma City in Fukushima, Japan.ParticipantsParticipants included pregnant women who applied for the voluntary internal radiation exposure screening programme.Primary and secondary outcome measuresInternal radiation exposure was evaluated using the whole-body counter (WBC) in the screening programme. Data from a food acquisition preference questionnaire administered to the participants were analysed and compared across the 5-year period after adjusting for covariates.ResultsOverall, 804 screening programmes were conducted with 579 participants during the study period. All participants had internal contamination levels below the detection limit of the WBC unit (220 and 250 Bq/body for Cs-134 and Cs-137, respectively). Based on the most conservative assumption, their maximum annual effective doses by Cs-134 and Cs-137 together were estimated at 16 µSv/year. Contrary to limited internal contamination risks and counter-dose initiatives by the government, a considerable number of pregnant women were still concerned about consuming potentially contaminated local food products when purchasing them at supermarkets between 2012 (78.4%) and 2015 (75.0%).ConclusionsHealth effects from post-accident internal radiation exposure were likely to be insignificant in pregnant women. National/local action is urgently needed to promote scientific understanding in pregnant women regarding limited internal exposure risks from local food products in the market. However, few mothers chose to participate in the internal radiation exposure screening programme, and thus, caution is required in interpreting the results of analyses.
Effect of diet, exercise and sleep on tic severity: a scoping review protocol
Authors: Nosratmirshekarlou Elaheh , Shafiq Samreen , Goodarzi Zahra S , Martino Davide , Pringsheim Tamara 
Published: July 2019

IntroductionTourette syndrome is a common childhood-onset neuropsychiatric disorder, with tics that wax and wane in frequency and severity over time. The purpose of the proposed scoping review is to map the types of evidence available pertaining to the effect of diet, sleep and exercise on tic severity and identify key concepts and gaps in research.MethodsOur scoping review will use the six-step framework recommended by Arksey and O’Malley, with enhancements from Levacet aland Joanna Briggs Institute. We will attempt to identify all the relevant literature regardless of study design. We will search six electronic databases, the reference lists of all selected studies and the grey literature for studies examining an association between dietary factors, sleep or physical exercise and tics, or studies of interventions targeting diet, sleep or exercise to reduce tics. Our analysis plan includes description of the reported associations among dietary factors, sleep and physical exercise and tics, the effects of interventions, the research methodologies and how outcomes are measured.Ethics and disseminationAn approval from a recognised committee is not required to conduct the proposed review, as the study entails secondary analysis of the literature available publicly. For dissemination of the study, the results will be submitted for publication to peer-reviewed scientific journals and presented at relevant public forums and conferences.
A tailored approach towards informing relatives at risk of inherited cardiac conditions: study protocol for a randomised controlled trial
Authors: van den Heuvel Lieke M , Hoedemaekers Yvonne M , Baas Annette F , van Tintelen J Peter , Smets Ellen M A , Christiaans Imke 
Published: July 2019

IntroductionIn current practice, probands are asked to inform relatives about the possibility of predictive DNA testing when a pathogenic variant causing an inherited cardiac condition (ICC) is identified. Previous research on the uptake of genetic counselling and predictive DNA testing in relatives suggests that not all relatives are sufficiently informed. We developed a randomised controlled trial to evaluate the effectiveness of a tailored approach in which probands decide together with the genetic counsellor which relatives they inform themselves and which relatives they prefer to have informed by the genetic counsellor. Here, we present the study protocol of this randomised controlled trial.MethodsA multicentre randomised controlled trial with parallel-group design will be conducted in which an intervention group receiving the tailored approach will be compared with a control group receiving usual care. Adult probands diagnosed with an ICC in whom a likely pathogenic or pathogenic variant is identified will be randomly assigned to the intervention or control group (total sample: n=85 probands). Primary outcomes are uptake of genetic counselling and predictive DNA testing by relatives (total sample: n=340 relatives). Secondary outcomes are appreciation of the approach used and impact on familial and psychological functioning, which will be assessed using questionnaires. Relatives who attend genetic counselling will be asked to fill out a questionnaire as well.Ethics and disseminationEthical approval was obtained from the Medical Ethical Committee of the Amsterdam University Medical Centres (MEC 2017-145), the Netherlands. All participants will provide informed consent prior to participation in the study. Results of the study on primary and secondary outcome measures will be published in peer-reviewed journals.Trial registration numberNTR6657; Pre-results.
Is maternal weight gain between pregnancies associated with risk of large-for-gestational age birth? Analysis of a UK population-based cohort
Authors: Ziauddeen Nida , Wilding Sam , Roderick Paul J , Macklon Nicholas S , Alwan Nisreen A 
Published: July 2019

ObjectiveMaternal overweight and obesity during pregnancy increases the risk of large-for-gestational age (LGA) birth and childhood obesity. We aimed to investigate the association between maternal weight change between subsequent pregnancies and risk of having a LGA birth.DesignPopulation-based cohort.SettingRoutinely collected antenatal healthcare data between January 2003 and September 2017 at University Hospital Southampton, England.ParticipantsHealth records of women with their first two consecutive singleton live-birth pregnancies were analysed (n=15 940).Primary outcome measureRisk of LGA, recurrent LGA and new LGA births in the second pregnancy.ResultsOf the 15 940 women, 16.0% lost and 47.7% gained weight (≥1 kg/m2) between pregnancies. A lower proportion of babies born to women who lost ≥1 kg/m2(12.4%) and remained weight stable between −1 and 1 kg/m2(11.9%) between pregnancies were LGA compared with 13.5% and 15.9% in women who gained 1–3 and ≥3 kg/m2, respectively. The highest proportion was in obese women who gained ≥3 kg/m2(21.2%). Overweight women had a reduced risk of recurrent LGA in the second pregnancy if they lost ≥1 kg/m2(adjusted relative risk (aRR) 0.69, 95% CI 0.48 to 0.97) whereas overweight women who gained ≥3 kg/m2were at increased risk of new LGA after having a non-LGA birth in their first pregnancy (aRR 1.35, 95% CI 1.05 to 1.75). Normal-weight women who gained weight were also at increased risk of new LGA in the second pregnancy (aRR 1.26, 95% CI 1.06 to 1.50 with gain of 1–3 kg/m2and aRR 1.34, 95% CI 1.09 to 1.65 with gain of ≥3 kg/m2).ConclusionsLosing weight after an LGA birth was associated with a reduced LGA risk in the next pregnancy in overweight women, while interpregnancy weight gain was associated with an increased new LGA risk. Preventing weight gain between pregnancies is an important measure to achieve better maternal and offspring outcomes.
Safety and efficacy of amnion-derived mesenchymal stem cells (AM01) in patients with steroid-refractory acute graft-versus-host disease after allogeneic haematopoietic stem cell transplantation: a study protocol for a phase I/II Japanese trial
Authors: Yamahara Kenichi , Hamada Akiko , Soma Toshihiro , Okamoto Rika , Okada Masaya , Yoshihara Satoshi , Yoshihara Kyoko , Ikegame Kazuhiro , Tamaki Hiroya , Kaida Katsuji , Inoue Takayuki , Ohsugi Yuko , Nishikawa Hiroki , Hayashi Hiroshi , Ito Yoichi M , Iijima Hiroaki , Ohnishi Shunsuke , Hashimoto Daigo , Isoe Toshiyuki , Teshima Takanori , Ogawa Hiroyasu , Sato Norihiro , Fujimori Yoshihiro 
Published: July 2019

IntroductionRegenerative medicine and cell therapies have been gaining much attention among clinicians. Therapeutic infusion of mesenchymal stromal cells (MSCs) is now a leading investigational strategy for the treatment of acute graft-versus-host disease (aGVHD). Bone marrow MSCs are approved for manufacture and marketing as a cell therapy for aGVHD. Our non-clinical studies confirmed that human amnion-derived MSCs had immunomodulatory activity equal to or higher than that of human bone marrow MSCs. This study will aim to evaluate the safety and efficacy of amnion-derived MSCs (AM01) in patients with steroid-refractory aGVHD.Methods and analysisThis study will be a multicentre, single-arm, open-label trial (an interventional study). This clinical trial will begin with a low-dose group, and when safety has been confirmed in at least three cases in the low-dose group, treatment will begin for the high-dose group, for which the safety will also be verified. The primary endpoint is to assess the safety of intravenous infusion therapy of AM01 within 24 hours after intravenous infusion of AM01. The secondary endpoint is to explore the efficacy of intravenous infusion therapy with AM01.Ethics and disseminationThe institutional review boards of all participating hospitals approved this study protocol (latest V3.3.0, 3 August 2018). Final data will be publicly announced. A report releasing the study results will be submitted for publication to an appropriate peer-reviewed journal.Trial registration numberUMIN000029945.
Where there is no nurse: an observational study of large-scale mentoring of auxiliary nurses to improve quality of care during childbirth at primary health centres in India
Authors: Rao Krishna D , Srivastava Swati , Warren Nicole , Mayra Kaveri , Gore Aboli , Das Aritra , Ahmed Saifuddin 
Published: July 2019

ObjectiveClinician scarcity in Low and Middle-Income Countries (LMIC) often results in de facto task shifting; this raises concerns about the quality of care. This study examines if a long-term mentoring programme improved the ability of auxiliary nurse-midwives (ANMs), who function as paramedical community health workers, to provide quality care during childbirth, and how they compared with staff nurses.DesignQuasi-experimental post-test with matched comparison group.SettingPrimary health centres (PHC) in the state of Bihar, India; a total of 239 PHCs surveyed and matched analysis based on 190 (134 intervention and 56 comparison) facilities.ParticipantsAnalysis based on 335 ANMs (237 mentored and 98 comparison) and 42 staff nurses (28 mentored and 14 comparison).InterventionMentoring for a duration of 6–9 months focused on nurses at PHCs to improve the quality of basic emergency obstetric and newborn care.Primary outcome measuresNurse ability to provide correct actions in managing cases of normal delivery, postpartum haemorrhage and neonatal resuscitation assessed using a combination of clinical vignettes and Objective Structured Clinical Examinations.ResultsMentoring increased correct actions taken by ANMs to manage normal deliveries by 17.5 (95% CI 14.8 to 20.2), postpartum haemorrhage by 25.9 (95% CI 22.4 to 29.4) and neonatal resuscitation 28.4 (95% CI 23.2 to 33.7) percentage points. There was no significant difference between the average ability of mentored ANMs and staff nurses. However, they provided only half the required correct actions. There was substantial variation in ability; 41% of nurses for normal delivery, 60% for postpartum haemorrhage and 45% for neonatal resuscitation provided less than half the correct actions. Ability declined with time after mentoring was completed.DiscussionMentoring improved the ability of ANMs to levels comparable with trained nurses. However, only some mentored nurses have the ability to conduct quality deliveries. Continuing education programmes are critical to sustain quality gains.
Prehospital triage of patients with suspected stroke symptoms (PRESTO): protocol of a prospective observational study
Authors: Venema Esmee , Duvekot Martijne H C , Lingsma Hester F , Rozeman Anouk D , Moudrous Walid , Vermeij Frederique H , Biekart Marileen , van der Lugt Aad , Kerkhoff Henk , Dippel Diederik W J , Roozenbeek Bob 
Published: July 2019

IntroductionThe efficacy of both intravenous treatment (IVT) and endovascular treatment (EVT) for patients with acute ischaemic stroke strongly declines over time. Only a subset of patients with ischaemic stroke caused by an intracranial large vessel occlusion (LVO) in the anterior circulation can benefit from EVT. Several prehospital stroke scales were developed to identify patients that are likely to have an LVO, which could allow for direct transportation of EVT eligible patients to an endovascular-capable centre without delaying IVT for the other patients. We aim to prospectively validate these prehospital stroke scales simultaneously to assess their accuracy in predicting LVO in the prehospital setting.Methods and analysisPrehospital triage of patients with suspected stroke symptoms (PRESTO) is a prospective multicentre observational cohort study in the southwest of the Netherlands including adult patients with suspected stroke in the ambulance. The paramedic will assess a combination of items from five prehospital stroke scales, without changing the normal workflow. Primary outcome is the clinical diagnosis of an acute ischaemic stroke with an intracranial LVO in the anterior circulation. Additional hospital data concerning the diagnosis and provided treatment will be collected by chart review. Logistic regression analysis will be performed, and performance of the prehospital stroke scales will be expressed as sensitivity, specificity and area under the receiver operator curve.Ethics and disseminationThe Institutional Review Board of the Erasmus MC University Medical Centre has reviewed the study protocol and confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) is not applicable. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations. The best performing scale, or the simplest scale in case of clinical equipoise, will be integrated in a decision model with other clinical characteristics and real-life driving times to improve prehospital triage of suspected stroke patients.Trial registration numberNTR7595.
Study protocol for the validation of a new patient-reported outcome measure (PROM) of listening effort in cochlear implantation: the Listening Effort Questionnaire-Cochlear Implant (LEQ-CI)
Authors: Hughes Sarah E , Rapport Frances , Watkins Alan , Boisvert Isabelle , McMahon Catherine M , Hutchings Hayley A 
Published: July 2019

IntroductionListening effort may be defined as the cognitive resources needed to understand an auditory message. A sustained requirement for listening effort is known to have a negative impact on individuals’ sense of social connectedness, well-being and quality of life. A number of hearing-specific patient-reported outcome measures (PROMs) exist currently; however, none adequately assess listening effort as it is experienced in the listening situations of everyday life. The Listening Effort Questionnaire-Cochlear Implant (LEQ-CI) is a new, hearing-specific PROM designed to assess perceived listening effort as experienced by adult CI patients. It is the aim of this study to conduct the first psychometric evaluation of the LEQ-CI’s measurement properties.Methods and analysisThis study is a phased, prospective, multi-site validation study in a UK population of adults with severe-profound sensorineural hearing loss who meet local candidacy criteria for CI. In phase 1, 250 CI patients from four National Health Service CI centres will self-complete a paper version of the LEQ-CI. Factor analysis will establish unidimensionality and Rasch analysis will evaluate item fit, differential item functioning, response scale ordering, targeting of persons and items, and reliability. Classical test theory methods will assess acceptability/data completeness, scaling assumptions, targeting and internal consistency reliability. Phase 1 results will inform refinements to the LEQ-CI. In phase 2, a new sample of adult CI patients (n=100) will self-complete the refined LEQ-CI, the Speech, Spatial and Qualities of Hearing Scale, the Nijmegen Cochlear Implant Questionnaire and the Fatigue Assessment Scale to assess construct validity.Ethics and disseminationThis study was approved by the Abertawe Bro Morgannwg University Health Board/Swansea University Joint Study Review Committee and the Newcastle and North Tyneside 2 Research Ethics Committee, Ref: 18/NE/0320. Dissemination will be in high-quality journals, conference presentations and SEH’s doctoral dissertation.
Role ofFAM19A4/miR124-2methylation analysis in predicting regression or non-regression of CIN2/3 lesions: a protocol of an observational longitudinal cohort study
Authors: Kremer Wieke W , Berkhof Johannes , Bleeker Maaike CG , Heideman Daniëlle AM , van Trommel Nienke E , van Baal Marchien W , Verhoeve Harold R , Meijer Chris JLM , Kenter Gemma G 
Published: July 2019

IntroductionThe clinical course of high-grade cervical intraepithelial neoplasia (CIN2/3) is characterised by a high spontaneous regression rate. Histological assessment is unable to differentiate between CIN2/3 lesions likely to regress and those likely to persist or progress. Most CIN2/3 lesions are treated by surgical excision, leading to overtreatment of a substantial proportion. In this prospective study, we evaluate the value of DNA methylation of host cell genes, which has shown to be particularly sensitive for the detection of advanced CIN2/3 and cervical cancer, in the prediction of regression or non-regression of CIN2/3 lesions.Methods and analysisThis is a multicentre observational longitudinal study with 24-month follow-up. Women referred for colposcopy with an abnormal cervical scrape, who have been diagnosed with CIN2/3 and a small cervical lesion (≤50% of cervix) will be asked to participate. Participants will be monitored by 6-monthly cytological and colposcopic examination. In case of clinical progression, participants will receive treatment and exit the study protocol. At baseline and during follow-up, self-sampled cervicovaginal brushes and cervical scrapes will be collected for high-risk human papillomavirus (HPV) testing andFAM19A4/miR124-2methylation analysis. A colposcopy-directed biopsy will be taken from all participants at the last follow-up visit. The primary study endpoint is regression or non-regression at the end of the study based on the histological diagnosis. Regression is defined as CIN1 or less. Non-regression is defined as CIN2 or worse. The secondary study endpoint is defined as HPV clearance (double-negative HPV test at two consecutive time-points). The association between methylation status and regression probability will be evaluated by means of χ2testing.Ethics and disseminationEthics approval was obtained in all participating clinics. Results of the main study will be submitted for publication in a peer-reviewed journal.Trial registration numberNTR6069; Pre-results
Outcomes following early parenteral nutrition use in preterm neonates: protocol for an observational study
Authors: Webbe James , Longford Nicholas , Uthaya Sabita , Modi Neena , Gale Chris 
Published: July 2019

IntroductionPreterm babies are among the highest users of parenteral nutrition (PN) of any patient group, but there is wide variation in commencement, duration, and composition of PN and uncertainty around which groups will benefit from early introduction. Recent studies in critically unwell adults and children suggest that harms, specifically increased rates of nosocomial infection, outweigh the benefits of early administration of PN. In this study, we will describe early PN use in neonatal units in England, Wales and Scotland. We will also evaluate if this is associated with differences in important neonatal outcomes in neonates born between 30+0and 32+6weeks+daysgestation.Methods and analysisWe will use routinely collected data from all neonatal units in England, Wales and Scotland, available in the National Neonatal Research Database (NNRD). We will describe clinical practice in relation to any use of PN during the first 7 postnatal days among neonates admitted to neonatal care between 1 January 2012 and 31 December 2017. We will compare outcomes in neonates born between 30+0and 32+6weeks+daysgestation who did or did not receive PN in the first week after birth using a propensity score-matched approach. The primary outcome will be survival to discharge home. Secondary outcomes will include components of the neonatal core outcome set: outcomes identified as important by former patients, parents, clinicians and researchers.Ethics and disseminationWe have obtained UK National Research Ethics Committee approval for this study (Ref: 18/NI/0214). The results of this study will be presented at academic conferences; the UK charity Bliss will aid dissemination to former patients and parents.Trial registration numberNCT03767634
Quantitative analysis of the distal, lateral, and posterior articular branches of the axillary nerve to the shoulder: implications for intervention
Authors: Bickelhaupt Brittany , Eckmann Maxim S , Brennick Caroline , Rahimi Omid B 
Published: July 2019

IntroductionThe terminal sensory branches innervating the shoulder joint are potential therapeutic targets for the treatment of shoulder pain. This cadaveric study investigated in detail the anatomic pathway of the posterior terminal sensory branch of the axillary nerve (AN) and its relationship to nearby anatomic structures for applications, such as nerve block or ablation of the shoulder joint.MethodsFor this study, nine shoulders were dissected. Following dissection, methylene blue was used to stain the pathway of the terminal sensory branches of the AN to provide a visual relationship to the nearby bony structures. A transparent grid was overlaid on the humeral head to provide further detailed information regarding the innervation to the shoulder joint.ResultsEight of the nine shoulders displayed terminal sensory branches of the AN. The terminal sensory branches of the AN innervated the posterolateral head of the humerus and shoulder capsule and were deep and distal to the motor branches innervating the deltoid muscle and teres minor muscle. All terminal branches dissected innervated the shoulder capsule at the posteroinferior-lateral aspect of the greater tuberosity of the humerus. All specimens displayed innervation to the shoulder joint in the lateral most 25% and inferior most 37.5% before methylene blue staining.ConclusionThe terminal sensory branches of the AN consistently innervate the inferior and lateral aspects of the posterior humeral head and shoulder capsule. These nerves are easily accessible and would provide a practical target for nerve block or ablation to relieve shoulder pain without compromising motor integrity.