bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy and safety of recombinant human granulocyte colony-stimulating factor in patients with poor ovarian response: protocol for a multicentre, randomised, controlled trial
Authors: Zeng Xianghui , Du Lirong , Yang Huilin , Wang Fang 
Published: December 2023

IntroductionApproximately 17.5% of couples of reproductive age have experienced infertility. Women with a poor ovarian response (POR) must undergo in vitro fertilisation (IVF) and embryo transfer to achieve pregnancy. However, studies have reported a poor response to gonadotropin stimulation in women undergoing IVF-ET. Results from animal experiments suggest that granulocyte colony-stimulating factor (G-CSF) has a curative effect by protecting ovarian function, reducing follicle loss and delaying premature ovarian failure in rats caused by chemotherapy. Clinical studies on the therapeutic effect of G-CSF are deficient; therefore, this study will investigate its ability to improve ovum quality and maturity among women with POR undergoing IVF/intracytoplasmic sperm injection (ICSI).Methods and analysisThis clinical, multicentre, triple-blind, placebo-controlled trial will employ balanced randomisation (1:1). The planned sample size is 312 participants (156 subjects in each group). A total of 312 patients with infertility undergoing IVF/ICSI will be recruited from four public hospitals in China. The participants will be randomly divided into an experimental group (G-CSF) and a placebo group (control). All patients will be treated by using the progestin-primed ovarian stimulation superovulation protocol. The primary outcome will be D3 embryo quality. The number of ova obtained, MII ova and transferable embryos will be inclusive in the secondary outcome.Ethics and disseminationTo our knowledge, this is the first clinical trial to investigate the effect of G-CSF treatment timing and stimulation protocol in patients with POR in China. This study will provide new information about G-CSF efficacy among patients with POR undergoing IVF/ICSI and can help improve ovum quality and maturity. Clinical trials on this subject are deficient in China; therefore, a well-designed randomised trial is needed to determine the ability of G-CSF to improve ovum quality and maturity to facilitate conception among women with POR treated with IVF/ICSI.Trial registration numberChiCTR2200062412.
Infection prevention and control compliance of healthcare workers towards COVID-19 in conflict-affected public hospitals of Ethiopia
Authors: Daba Chala , Atamo Amanuel , Gebretsadik Weldehanna Daniel , Oli Abdi , Debela Sisay Abebe , Luke Amana Ogeto , Gebrehiwot Mesfin 
Published: December 2023

ObjectiveNon-compliance with COVID-19 infection prevention and control (IPC) is one of the global public health problems particularly among those frontline healthcare workers. However, there are no detailed investigations on COVID-19 IPC compliance among healthcare workers in conflict-affected settings. The objective of this research was to assess compliance with COVID-19 IPC measures and determine the factors associated with it among healthcare providers in Ethiopian governmental hospitals affected by conflict.DesignA cross-sectional study was carried out within institutional settings.Study setting and periodThe study was conducted in three public hospitals located in northeastern Ethiopia during the period of March to April 2022.ParticipantsSimple random sampling technique was used to select 325 healthcare workers after proportional allocation was made to each public hospital.Primary outcome measuresThe primary outcome was non-compliance with COVID-19 IPC. A multivariable logistic regression analysis was employed to identify factors associated with the lack of adherence to the COVID-19 IPC protocol.ResultsNearly half (150, 46.2%) of the healthcare workers had non-compliance with COVID-19 IPC protocol. Absence of hand washing soap (adjusted OR (AOR)=2.99; 95% CI 2.46 to 5.76), workload (AOR=2.25; 95% CI 1.33 to 3.84), disruption in the supply of piped water (AOR=1.82; 95% CI 1.11 to 2.99), did not undergo training in COVID-19 IPC (AOR=2.85; 95% CI 1.85 to 4.84), absence of COVID-19 IPC guidelines (AOR=2.14; 95% CI 1.11 to 4.13) and chewingkhat(AOR=2.3; 95% CI 1.32 to 3.72) were determinant factors for non-compliance.ConclusionsThe magnitude of non-compliance with COVID-19 IPC was high. Hospital managers and federal ministry of health should provide regular training on COVID-19 IPC, continuous piped water and personal protective facilities for healthcare workers. Ultimately, improving the security situation in the area would help improve COVID-19 IPC compliance among healthcare workers in these and other similar conflict-affected settings.
Social deprivation and exclusion in Parkinson’s disease: a cross-sectional and longitudinal study
Authors: Heimrich Konstantin G , Schönenberg Aline , Prell Tino 
Published: December 2023

ObjectiveTo describe prevalence and associated factors of social deprivation in people with Parkinson’s disease (PwPD).DesignCross-sectional and longitudinal cohort study.SettingData were taken from the Survey of Health, Ageing and Retirement in Europe (SHARE), a multidisciplinary, cross-national and longitudinal research project.ParticipantsCommunity-dwelling adults from waves 5 (2013, n=66 188) and 6 (2015, n=68 186) of the SHARE dataset. After longitudinal analyses, participants in wave 5 can be retrospectively divided into the following three subgroups: PwPD at wave 5 (n=559), people newly reported PD from wave 5 to wave 6 (prodromal PD; n=215) and people without PD (n=46 737).Outcome measuresThe prevalence and associated factors of social deprivation in PD, its impact on quality of life (QoL) and its onset within the course of PD.ResultsPwPD had higher indices for material and social deprivation than non-PD participants, and 20% of PwPD were at risk of social exclusion. Social deprivation alone accounted for 35% and material deprivation for 21% of QoL variance and remained significant predictors of QoL after adjustment for cofactors. Social deprivation and risk of social exclusion were already increased in people with prodromal PD, and accordingly preceded PD diagnosis in wave 6.ConclusionsFor the treatment of PD, we should consider the impact of social deprivation and exclusion on QoL and their association with mental and physical functioning. However, the relevance of social deprivation as a prodromal phenomenon requires further investigation.
Axial length to corneal radius of curvature ratio and refractive error in Chinese preschoolers aged 4–6 years: a retrospective cross-sectional study
Authors: Tang Tao , Zhao Heng , Liu Duanke , Li Xuewei , Wang Kai , Li Yan , Zhao Mingwei 
Published: December 2023

ObjectiveThis study aims to investigate the associations of axial length to corneal radius of curvature (AL/CRC) ratio with refractive error and to determine the effect of AL/CRC ratio on hyperopia reserve and myopia assessment among Chinese preschoolers.MethodsThis was a retrospective cross-sectional study that evaluated subjects aged 4–6 years. AL and CRC were obtained using a non-contact ocular biometer. Correlation analysis was performed to explore the associations of AL/CRC ratio with spherical equivalent refractive error (SER). The accuracy of AL/CRC ratio for hyperopia reserve and myopia assessment was analysed using cycloplegic refraction by drawing receiver operating characteristic (ROC) curves.ResultsThe analysis included 1024 participants (537 boys, 52.4%). The mean AL/CRC ratios in hyperopes, emmetropes and myopes were 2.90±0.06, 2.95±0.05 and 3.08±0.07, respectively. The SER was found to be more strongly correlated with AL/CRC ratio (ρ=−0.66, p<0.001) than either AL or CRC alone (ρ=−0.52, p<0.001; ρ=−0.03, p=0.33, respectively). AL/CRC was correlated with SER in hyperopes (ρ=−0.54, p<0.001), emmetropes (ρ=−0.33, p<0.001) and myopes (r=−0.67, p<0.001). For low hyperopia reserve assessment, the area under the ROC curves of AL/CRC ratio was 0.861 (95% CI 0.829 to 0.892), the optimal cut-off value of the AL/CRC ratio was ≥2.955. For myopia assessment, the area under the ROC curves of AL/CRC ratio was 0.954 (95% CI 0.925 to 0.982), the optimal cut-off value of the AL/CRC ratio was ≥2.975.ConclusionsThe SER showed a better correlation with AL/CRC ratio than either AL or CRC alone, especially in myopes, among children aged 4–6 years. These findings indicate that when cycloplegic refraction is unavailable, AL/CRC ratio could be used as an alternative indicator for identifying low hyperopia reserve and myopia among preschoolers, helping clinicians and parents screen children with low hyperopia reserve before primary school in a timely manner.
Effects of transcranial direct current stimulation combined with Pilates-based exercises in the treatment of chronic low back pain in outpatient rehabilitation service in Brazil: double-blind randomised controlled trial protocol
Authors: da Silva Aleilson Abner Câmara , Gomes Sâmara Raquel Alves , do Nascimento Rayssa Maria , Fonseca Adna Karolinne , Pegado Rodrigo , Souza Clécio Gabriel , Macedo Liane de Brito 
Published: December 2023

IntroductionChronic low back pain may be associated with pathoanatomical, neurophysiological, physical, psychological and social factors; thus, treatments to reduce symptoms are important to improve the quality of life of this population. We aimed to evaluate the effects of transcranial direct current stimulation (tDCS) combined with Pilates-based exercises compared with sham stimulation on pain, quality of life and disability in patients with chronic non-specific low back pain.Methods and analysisThis is a protocol for a double-blind randomised controlled trial with participants, outcome assessor and statistician blinded. We will include 36 individuals with a history of non-specific chronic low back pain for more than 12 weeks and minimum pain intensity of 3 points on the Numerical Pain Rating Scale. Individuals will be randomised into two groups: (1) active tDCS combined with Pilates-based exercises and (2) sham tDCS combined with Pilates-based exercises. Three weekly sessions of the protocol will be provided for 4 weeks, and individuals will be submitted to three assessments: the first (T0) will be performed before the intervention protocol, the second (T1) immediately after the intervention protocol and the third (T2) will be a follow-up 1 month after the end of the intervention. We will assess pain, disability, central sensitisation, quality of life, pressure pain threshold, global impression of change, adverse events and medication use. The Numerical Pain Rating Scale and the Roland-Morris Disability Questionnaire will be used at T1 to assess pain and disability, respectively, as primary outcome measures.Ethics and disseminationThis trial was prospectively registered in ClinicalTrials.gov website and ethically approved by the Ethics and Research Committee of the Faculty of Health Sciences of Trairi (report number: 5.411.244) before data collection. We will publish the results in a peer-reviewed medical journal and on institution websites.Trial registration numberClinicalTrials.gov (NCT05467566).
Shepherding parents to prepare for end-of-life decision-making: a critical phenomenological study of the communication approach of paediatricians caring for children with life-limiting conditions in Australia
Authors: Vemuri Sidharth , Hynson Jenny , Williams Katrina , O'Neill Jenny , Gillam Lynn 
Published: December 2023

Background/objectivesShared decision-making is widely accepted as the best approach for end-of-life decision-making for children with life-limiting conditions. Both paediatricians and parents find benefit in preparing for such decisions. However, little detail is known about this preparatory process. This study aims to explore how paediatricians prepare parents for end-of-life decision-making for a child with a life-limiting condition using clinical simulation.DesignIndividual, semistructured, post-simulation qualitative interviews of paediatricians and parent-actors.SettingAcute intensive and long-term outpatient paediatric care in Victoria, Australia.Participants18 purposively sampled paediatricians who treat children with life-limiting conditions and the two parent-actors involved in all simulations. Paediatricians were excluded if they assisted in the study design, worked within specialist palliative care teams or did not provide clinical care outside the neonatal period.ResultsThree key themes in a preparatory process (termed ‘shepherding’) were identified: (1) paediatricians aim to lead parents along a pathway to future end-of-life decisions, (2) paediatricians prefer to control the pace of these discussions and (3) paediatricians recognise they need to have courage to face risk with this preparation. Paediatricians use a variety of shepherding strategies to influence the pace, content and framing of discussions, which may help prepare parents to make the best end-of-life treatment decisions when the time comes.ConclusionsShepherding is a newly identified, subtle process intended to influence parents by guiding their understanding of their child’s health and potential suffering in advance of decision-making. Shepherding does not fit within current descriptions of physicians’ decision-making influence. Paced reflection, thinking and provision of information are shepherding strategies preferred by paediatricians, and these appear the same regardless of whether paediatricians intend to steer parents towards particular treatment decisions or simply prepare them for the process of decision-making. Further study about the intention of this influence and parental perception of this communication is needed.
Effects of armed conflict on maternal and infant health: a mixed-methods study of Armenia and the 2020 Nagorno-Karabakh war
Authors: Rostomian Lara , Chiloyan Araz , Hentschel Elizabeth , Messerlian Carmen 
Published: December 2023

IntroductionArmed conflict worldwide and across history has harmed the health of populations directly and indirectly, including generations beyond those immediately exposed to violence. The 2020 war between Armenia and Azerbaijan over Nagorno-Karabakh, inhabited by an ethnically Armenian population, provides an example of how conflict harmed health during COVID-19. We hypothesised that crises exposure would correspond to decreased healthcare utilisation rates and worse health outcomes for the maternal and infant population in Armenia, compounded during the pandemic.MethodsFollowing a mixed-methods approach, we used ecological data from 1980 to 2020 to evaluate health trends in conflict, measured as battle-related deaths (BRDs), COVID-19 cases, and maternal and infant health indicators during periods of conflict and peace in Armenia. We also interviewed 10 key informants about unmet needs, maternal health-seeking behaviours and priorities during the war, collecting recommendations to mitigate the effects of future crisis on maternal and infant health. We followed a deductive coding approach to analyse transcripts and harvest themes.ResultsBRDs totalled more in the 2020 war compared with the previous Nagorno-Karabakh conflicts. Periods of active conflict between 1988–2020 were associated with increased rates of sick newborn mortality, neonatal mortality and pre-eclampsia or eclampsia. Weekly average COVID-19 cases increased sevenfold during the 2020 Nagorno-Karabakh war. Key informants expressed concerns about the effects of stress and grief on maternal health and pregnancy outcomes and recommended investing in healthcare system reform. Participants also stressed the synergistic effects of the war and COVID-19, noting healthcare capacity concerns and the importance of a strong primary care system.ConclusionsMaternal and infant health measures showed adverse trends during the 2020 Nagorno-Karabakh war, potentially amplified by the concurrent COVID-19 pandemic. To mitigate effects of future crises on population health in Armenia, informants recommended investments in healthcare system reform focused on primary care and health promotion.
Correlational study of ergonomic knowledge and level of MSK discomfort during online classes of 1st–4th year UST-CRS physical therapy students: a cross-sectional study
Authors: Siy Warrick , Sicat Zyra Mae , Bautista Trisha Mae , Formalejo Andrei , Gatdula Marx Emmanoelle , Ico Ayhessa Ann , Julian Carl James , Pabion Ma Cazandra , Reyes Juan Lorenzo , Santander Nicholai Marian 
Published: December 2023

IntroductionThe abrupt transition of the mode of learning due to the COVID-19 pandemic resulted in an increase in complaints of musculoskeletal (MSK) discomfort among students in Higher Education Institutions (HEI). Inadequate physical space and equipment are one major cause of these complaints. Among HEIs, physical therapy (PT) students have sufficient background in managing MSK discomforts. However, this does not prevent them from experiencing pain and discomfort during online classes. This analytical cross-sectional study aims to determine the correlation between ergonomic knowledge and MSK discomfort among first-year to fourth-year PT students.Methods and analysisThe study will use two questionnaires, theErgonomic Knowledge Questionnaire,and theCornell Musculoskeletal Discomfort Questionnaire,that determine the level of ergonomic knowledge and MSK discomfort, respectively. This will be disseminated to 144 students through google forms. Results will then be analysed using Pearson Correlation Test. The study anticipates a correlation between the level of ergonomic knowledge and MSK discomfort among the participants.Ethics and disseminationThe study has been approved by the University of Santo Tomas-College of Rehabilitation Sciences Ethics Review Committee. The participants will receive the results prior to publication in a peer-reviewed scientific journal.Trial registration numberPhilippine Health Research Registry with registry ID PHRR230216-005443.
Does Health & Her app use improve menopausal symptoms? A longitudinal cohort study
Authors: Andrews Robin , Lancastle Deborah , Bache Kate , Lacey Arron S 
Published: December 2023

ObjectivesThe Health & Her app provides menopausal women with a means of monitoring their symptoms, symptom triggers and menstrual periods, and enables them to engage in a variety of digital activities designed to promote well-being. This study aimed to examine whether sustained weekly engagement with the app is associated with improvements in menopausal symptoms.DesignA pre–post longitudinal cohort study.SettingAnalysed data collected from Health & Her app users.Participants1900 women who provided symptom data via the app across a 2-month period.Primary and secondary outcome measuresSymptom changes from baseline to 2 months was the outcome measure. A linear mixed effects model explored whether levels of weekly app engagement influenced symptom changes. Secondary analyses explored whether app-usage factors such as total number of days spent logging symptoms, reporting triggers, reporting menstrual periods and using in-app activities were independently predictive of symptom changes from baseline. Covariates included hormone replacement therapy use, hormonal contraceptive use, present comorbidities, age and dietary supplement use.ResultsFindings demonstrated that greater engagement with the Health & Her app for 2 months was associated with greater reductions in symptoms over time. Daily use of in-app activities and logging symptoms and menstrual periods were each independently associated with symptom reductions.ConclusionsThis study demonstrated that greater weekly engagement with the app was associated with greater reductions in symptoms. It is recommended that women be made aware of menopause-specific apps, such as that provided by Health & Her, to support them to manage their symptoms.
Recurrent bacterial meningitis in children in the Netherlands: a nationwide surveillance study
Authors: Snoek Linde , van Kassel Merel N , Koelman Diederik L H , van der Ende Arie , van Sorge Nina M , Brouwer Matthijs C , van de Beek Diederik , Bijlsma Merijn W 
Published: December 2023

ObjectivesThis study aimed to estimate the recurrence rate of culture-positive bacterial meningitis in children in the Netherlands.DesignNationwide surveillance study, using the database of the Netherlands Reference Laboratory for Bacterial Meningitis to identify patients with culture-positive bacterial meningitis during childhood.SettingThe study was based in the Netherlands.ParticipantsA total of 9731 children with a first bacterial meningitis episode between 1 July 1987 and 30 June 2019 were identified.Primary and secondary outcome measuresRecurrence was defined as a subsequent episode >28 days, or caused by a different pathogen. Annual incidence and incidence rate ratios (IRRs) comparing the periods 1988–2003 and 2004–2019 were calculated. Predictors of recurrent meningitis were assessed using Cox proportional hazards regression.ResultsSixty-three (0.6%) of the 9731 children with a first bacterial meningitis episode contracted recurrent meningitis.Neisseria meningitidiswas the leading pathogen for first meningitis episodes (52%) andStreptococcus pneumoniaefor recurrent episodes (52%). The median annual incidence of first episodes per 100 000 children decreased from 11.81 (IQR 11.26–17.60) in 1988–2003 to 2.60 (IQR 2.37–4.07) in 2004–2019 (IRR 0.25, 95% CI 0.23 to 0.26). The incidence of recurrences did not change: 0.06 (IQR 0.02–0.11) in 1988–2003 to 0.03 (IQR 0.00–0.06) in 2004–2019 (IRR 0.65, 95% CI 0.39 to 1.1). Age above 5 years (OR 3.6 (95% CI 1.5 to 8.3)) and a first episode due toEscherichia coli(OR 25.7 (95% CI 7.2 to 92.0)) were associated with higher risks of recurrence.ConclusionThe recurrence rate of childhood bacterial meningitis in the Netherlands was 0.6%. While the incidence rate of first episodes decreased substantially, this was not the case for recurrent episodes. Older age and a first episode due toE. coliwere associated with higher recurrence risks.
Human umbilical cord-derived mesenchymal stem cells for the treatment of decompensated cirrhosis (MSC-DLC-1): a dose-escalation, phase I trial protocol
Authors: Wang Zerui , Li Tiantian , Zhang Ziying , Yuan Mengqi , Shi Ming , Wang Fu-Sheng , Linghu En-Qiang , Shi Lei 
Published: December 2023

IntroductionThere are limited therapeutic options to efficiently treat patients with decompensated liver cirrhosis. This trial aims to explore the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (UC-MSCs) for the treatment of patients with decompensated liver cirrhosis.Methods and analysisThis study is an open-label, dose-escalation, one-armed phase I trial. A single injection of UC-MSCs will be administered in a predetermined dose in each cohort (5.0×107, 1.0×108, 1.5×108or 2.0×108cells) according to the ‘3+3’ rule. The primary evaluation measures will include the incidence of adverse events and the change in the Model for End-stage Liver Disease (MELD) score from baseline to the 28th day. Secondary evaluation measures will be evaluated at baseline and at each follow-up point. These measures will include the change in the MELD score from baseline to each follow-up point, the incidence of each complication associated with decompensated cirrhosis, liver transplant-free survival and the incidence of liver failure, among other relevant measures. All patients will be followed up for 24 months. This study will evaluate whether the use of UC-MSCs to treat patients with decompensated liver cirrhosis is safe and tolerable.Ethics and disseminationThe study has been approved by the Chinese People’s Liberation Army General Hospital (Approval#: 2018-107-D-4). Once conducted, the results from the study will be published in a peer-reviewed journal.Trial registration numberNCT05227846.