bluuebunny/crossref_metadata_2025_split huggingface dataset:
Exploring the feasibility of establishing a core set of sexual, reproductive, maternal, newborn, child and adolescent health indicators in humanitarian settings: a multimethods, multicountry qualitative study protocol
Authors: Kobeissi Loulou Hassan , Ashna Manizha , Messier Kassandre , Moran Allisyn C , Say Lale , Strong Kathleen Louise , Foster Angel 
Published: December 2021

IntroductionIn 2019, over 70 million people were forcibly displaced worldwide. Women and girls comprise nearly half of this population and are at heightened risk of negative sexual and reproductive health outcomes. With the collapse of health systems, reduced resources and increased vulnerabilities from displacement, there is a need to strengthen current practices and ensure the delivery of comprehensive sexual, reproductive, maternal, newborn, child and adolescent health (SRMNCAH) services. Recognising the need for consistency in data collection, analysis and use, the WHO developed a list of core SRMNCAH monitoring and evaluation indicators for services and outcomes in humanitarian settings. This research will explore the feasibility of collecting this core set of SRMNCAH indicators in displacement contexts.Methods and analysisWe will undertake a multimethods qualitative study in seven humanitarian settings: Afghanistan, Albania, Bangladesh, Cameroon, the Democratic Republic of the Congo, Iraq and Jordan. We selected sites that reflect diversity in geographic region, sociocultural characteristics, primary location(s) of displaced persons and nature and phase of the crisis. Our study consists of four components: key informant interviews, facility assessments, observational sessions at select facilities and focus group discussions with front-line healthcare personnel. We will analyse our data using descriptive statistics and for content and themes. We will begin by analysing data from each setting separately and will then combine these data to explore concordant and discordant results, triangulate findings and develop global recommendations.Ethics and disseminationThe University of Ottawa’s Research Ethics Board and the Research Project Review Panel (RP 2) of the World Health Organization-Department of Sexual and Reproductive Health as well as local IRBs of PIs’ research institutions reviewed and approved this protocol. We intend to disseminate findings through workshops at the WHO country, regional and headquarter levels, as well as through local, national and international conferences, workshops, peer-reviewed publications, and reports.
Prevalence of specific micronutrient deficiencies in urban school going children of India aged between 6 and 16 years: study protocol for a multicentric cross-sectional study
Authors: Awasthi Shally , Kumar Divas , Singh Shweta , Dixit Swati , Agarwal Girdhar , Mahdi Abbas Ali 
Published: December 2021

IntroductionChildhood and adolescence are the period of rapid physical and cognitive growth and development, requiring adequate nutrition. Malnutrition in the form of undernutrition or micronutrient deficiency or overweight/obesity affects the health, cognition and educational achievement of this age group. The objective of this study is to assess the prevalence of calcium, iron, zinc, selenium, folate, vitamin A, 25 hydroxy vitamin D and vitamin B12 deficiencies in the serum and haemoglobin, ferritin and lead levels and its association with reported dietary intake and cognitive abilities, in urban school going children aged 6–16 years in 10 cities of India.Methods and analysisA multicentric cross-sectional study will be conducted to recruit 2400 participants (240 per site) across India. Participants will be selected using random sampling and will be categorised into age groups of 6–11 years and 12–16 years, with equal distribution. Data on socioeconomic status, anthropometric measures and 3-day dietary intake and cognitive performance will be collected. Blood samples will be collected for biochemical analysis of micronutrients. Findings will estimate the prevalence of micronutrient deficiencies and their association with dietary habits and cognitive functioning.Ethics and disseminationStudy protocol has been reviewed and approved by institutional ethics committee of all 10 participating sites. Results will be shared and published in a peer-reviewed journal, so that the findings will be helpful for the stakeholders in planning nutritional interventions for targeted groups.Trial registration numberCTRI/2019/02/017783.
Sociological variety and the transmission efficiency ofMycobacterium tuberculosis: a secondary analysis of qualitative and quantitative data from 15 communities in Zambia
Authors: Murray Emma J , Dodd Peter J , Marais Ben , Ayles Helen , Shanaube Kwame , Schaap Albertus , White Richard G , Bond Virginia 
Published: December 2021

ObjectivesSelected Zambian communities formed part of a cluster randomised trial: the Zambia and South Africa TB and AIDS Reduction study (ZAMSTAR). There was wide variability in the prevalence ofMycobacterium tuberculosisinfection and tuberculosis (TB) disease across these communities. We sought to clarify whether specific communities could have been more/less vulnerable toM. tuberculosistransmission as a result of sociological variety relevant to transmission efficiency.DesignWe conducted a mixed methods secondary analysis using existing data sets. First, we analysed qualitative data to categorise and synthesise patterns of socio-spatial engagement across communities. Second, we compared emergent sociological variables with a measure of transmission efficiency: the ratio of the annual risk of infection to TB prevalence.SettingZAMSTAR communities in urban and peri-urban Zambia, spanning five provinces.ParticipantsFifteen communities, each served by a health facility offering TB treatment to a population of at least 25 000. TB notification rates were at least 400 per 100 000 per annum and HIV seroprevalence was estimated to be high.ResultsCrowding, movement, livelihoods and participation in recreational activity differed across communities. Based on 12 socio-spatial indicators, communities were qualitatively classified as more/less spatially crowded and as more/less socially ‘open’ to contact with others, with implications for the presumptive risk ofM. tuberculosistransmission. For example, watching video shows in poorly ventilated structures posed a presumptive risk in more socially open communities, while outdoor farming and/or fishing were particularly widespread in communities with lower transmission measures.ConclusionsA dual dynamic of ‘social permeability’ and crowding appeared relevant to disparities inM. tuberculosistransmission efficiency. To reduce transmission, certain socio-spatial aspects could be adjusted (eg, increasing ventilation on transport), while more structural aspects are less malleable (eg, reliance on public transport). We recommend integrating community level typologies with genome sequencing techniques to further explore the significance of ‘social permeability’.Trial registration numberISRCTN36729271.
Study protocol: haemostatic efficacy and safety of preemptive antifibrinolysis with multidose intravenous tranexamic acid in elderly hip fracture patients: design of a prospective randomised controlled trial
Authors: Liu Jiacheng , Lei Yiting , Liao Junyi , Liang Xi , Hu Ning , Huang Wei 
Published: December 2021

IntroductionHip fracture surgery is often associated with substantial blood loss and a high allogeneic blood transfusion (ABT) rate. Preoperative hidden blood loss (HBL) has been observed clinically but there is little evidence for the efficacy of tranexamic acid (TXA) in controlling preoperative HBL. We designed a randomised controlled trial to evaluate the efficacy of preemptive antifibrinolysis with multidose intravenous TXA (IV-TXA) in reducing preoperative HBL in elderly patients with hip fractures.Methods and analysisThis is a prospective, randomised, placebo-controlled clinical trial. Patients older than 65 years diagnosed with primary unilateral femoral neck fracture or intertrochanteric fracture will be randomly assigned to group A (receiving 100 mL of intravenous normal saline every 12 hours preoperatively and 1.5 g of IV-TXA every 12 hours postoperatively for 3 days) or group B (receiving 1.5 g of IV-TXA every 12 hours preoperatively and 1.5 g of IV-TXA every 12 hours postoperatively for 3 days). The primary outcomes will be the hidden blood loss, haemoglobin decrease and ABT rate. The secondary outcomes include the levels of inflammatory factors (such as C reactive protein) and coagulation and fibrinolysis parameters (such as D-dimer). Other outcomes such as injury time, length of stay and hospitalisation expenses will also be compared between groups.Ethics and disseminationThis study has been approved by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University. The findings of the study will be disseminated through peer-reviewed journals and conference presentations.Trial registration numberChiCTR2100045960.
Efficacy and safety of combination treatment of double plasma molecular adsorption system and low volume plasma exchange for patients with hepatitis B virus related acute-on-chronic liver failure: a multicentre randomised controlled clinical trial
Authors: Xu Wenxiong , Li Yangmei , Wang Lu , Gao Hongbo , Chen Jinjun , Yuan Jing , Ouyang Yi , Gao Yufeng , Li Jianguo , Li Xuejun , Peng Liang 
Published: December 2021

IntroductionHepatitis B virus (HBV) related acute-on-chronic liver failure (ACLF) is still a common type of liver failure in China. Therefore, we conduct this multicentre, non-blinded, randomised controlled clinical trial to investigate the efficacy and safety of combination treatment of double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (PE) for patients with HBV related ACLF.Methods and analysisA total of 200 patients with HBV related ACLF in the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou Eighth People’s Hospital, Nanfang Hospital of Southern Medical University, The Third People’s Hospital of Shenzhen, Xiangya Hospital of Central South University and The First Affiliated Hospital of Anhui Medical University, will be recruited into this trial. Eligible patients will undergo randomisation at a 1:1 ratio to two arms: the control group and the trial group. Patients in control group will receive comprehensive internal medical treatment. Patients in trial group will receive treatment of DPMAS and sequential low volume PE for three times, and comprehensive internal medical treatment. Clinical safety will be assessed by the analysis of adverse events (AEs) and laboratory tests. The primary efficacy outcome will be the incidence of unfavored events including death, liver transplantation and treatment abandonment. The secondary efficacy outcome will be the model for end-stage liver disease score variation. All evaluations will be performed at baseline, and 4, 8, 12, 24, 36, 48 weeks after enrolment. All AEs will be reported as soon as they are noted during the entire study procedure.Ethics and disseminationThis study was approved by Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University (approval no. (2020)02-173-01). The results and conclusions of this clinical trial will be published at academic conferences or in journals.Trial registration numberNCT04597164.
Randomised controlled trial to investigate optimal antithrombotic therapy in patients with non-valvular atrial fibrillation undergoing percutaneous coronary intervention: a study protocol of the OPTIMA-AF trial
Authors: Sotomi Yohei , Kozuma Ken , Kashiwabara Kosuke , Higuchi Yoshiharu , Ando Kenji , Morino Yoshihiro , Ako Junya , Tanabe Kengo , Muramatsu Takashi , Nakazawa Gaku , Hikoso Shungo , Sakata Yasushi 
Published: December 2021

IntroductionThe optimal antithrombotic strategy for patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) is uncertain. For patients with non-AF, many trials are now evaluating short 1-month dual antiplatelet therapy. In patients with AF undergoing PCI, in contrast, short dual therapy (P2Y12 inhibitor +direct oral anticoagulant (DOAC)) has not yet been evaluated.Methods and analysisThe OPTIMA-AF trial (OPTIMAl antiplatelet therapy in combination with direct oral anticoagulants in patients with non-valvular Atrial Fibrillation undergoing percutaneous coronary intervention with everolimus-eluting stent) is an investigator-initiated, open-label, nationwide, multicentre, prospective, randomised controlled trial. The primary objective is to compare the efficacy and safety of short dual therapy (1-month DOAC +P2Y12 inhibitor followed by DOAC monotherapy) against long dual therapy (12-month DOAC +P2Y12 inhibitor followed by DOAC monotherapy) in the treatment of AF subjects undergoing PCI. The primary efficacy endpoint is a composite of death or thromboembolic events (myocardial infarction, definite stent thrombosis, stroke or systemic embolism) at 365 days; and the primary safety endpoint is bleeding (International Society on Thrombosis and Haemostasis major or clinically relevant non-major bleeding) at 365 days. This trial is intended to show the non-inferiority of short dual therapy versus long dual therapy in terms of the primary efficacy endpoint and show superiority in terms of the primary safety endpoint. A total of 1090 subjects will be randomised in a 1:1 ratio at approximately 60 sites.Ethics and disseminationThis study received approval from the Certified Review Board of Osaka University (a certified research ethics committee by the Japanese Clinical Research Act). The findings will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberJapan Registry of Clinical Trials: jRCTs051190053; Pre-results.
Construct validity of a clinically correlated knee osteoarthritis ultrasonographic scale: a cross-sectional observational study
Authors: Mortada Mohamed , Dawa Ghada A , Amer Youmna A 
Published: December 2021

ObjectivesTo assess the validity of a novel ultrasonographic scale for knee osteoarthritis (KOA) and its relation with the degree of pain and clinical features.DesignA cross-sectional observational study including 245 patients with knee pain who fulfilled the American College of Rheumatology criteria for KOA. All patients were subjected to clinical assessment Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) scale, global visual analogue scale (VAS) and functional assessment through the use of Health Assessment Questionnaire-II (HAQ-II). Ultrasonographic assessment was conducted following ZAGAZIG scale comprising five domains: one for degenerative features (one-third of total score) and the other four for inflammatory features (two-thirds of score).ResultsThere were positive correlations between ZAGAZIG score and all WOMAC subscales (pain, stiffness and function) (r=0.71, p=0.00; r=0.62, p=0.00; r=0.70, p=0.00, respectively).Moreover, there was a strong positive correlation between ZAGAZIG scale and both VAS and HAQ-II (r=0.82, p=0.00 and r=0.67, p=0.00). At cut-off point of >5, total US score distinguishes between patients with KOA with no or mild pain and those with moderate pain (87.2 sensitivity and 87.2 specificity). At cut-off point of 7, total score of ZAGAZIG scale distinguishes between patients with KOA with moderate pain and those with severe pain (94.5 sensitivity and 42.5 specificity).ConclusionZAGAZIG scale constitutes a validated tool for KOA assessment. ZAGAZIG scale correlated with WOMAC subscales (pain, stiffness and function), VAS and HAQ.
Effect of repetitive transcranial magnetic stimulation on patients with severe depression: a study protocol for systematic review and meta-analysis of randomised clinical trials
Authors: Han Fang , Tao Shuai , Liang Shanshan , Li Danyang , Me Yutong , Fan Hongyu , Wu Hao , Zhang Gaofeng 
Published: December 2021

IntroductionDepression is characterised by easy recurrence, high disability and high burden, and antidepressant therapy is the standard treatment. However, its treatment effect on patients with severe depressive disorder has been unsatisfactory. Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS), as a neurotherapy, can effectively mitigate the severity of depressive symptoms. Yet, more evidence is still required for TMS to treat severe depression. This study will be the first systematic review of the efficacy and tolerability of TMS for treating severe depression. We expect it to guide future clinical practice of TMS for the treatment of psychiatric disorders.Methods and analysisWe will search for the randomised controlled trial (RCT) involving rTMS for treating depression in eight electronic databases, including PubMed, Web of Science, EMBASE, the Cochrane Library and Wanfang Database, from publication up to September 2021. We will define Improvement in depressive symptoms, the difference between pretreatment (baseline) and post-treatment as the primary outcomes. The difference between pretreatment and post-treatment changes in resting state fMRI will be regarded as the secondary outcomes. Quality assessment of the included articles will be independently performed according to the Cochrane Risk of Bias tool.Ethics and disseminationEthical approval is not essential because there is no need to collect individual patient data. And this study will be published in a peer-reviewed journal.Trial registration numberCRD42020211460.
Lockdown and non-COVID-19 deaths: cause-specific mortality during the first wave of the 2020 pandemic in Norway: a population-based register study
Authors: Raknes Guttorm , Strøm Marianne Sørlie , Sulo Gerhard , Øverland Simon , Roelants Mathieu , Juliusson Petur Benedikt 
Published: December 2021

ObjectiveTo explore the potential impact of the first wave of COVID-19 pandemic on all cause and cause-specific mortality in Norway.DesignPopulation-based register study.SettingThe Norwegian cause of Death Registry and the National Population Register of Norway.ParticipantsAll recorded deaths in Norway from March to May from 2010 to 2020.Main outcome measuresRate (per 100 000) of all-cause mortality and causes of death in the European Shortlist for Causes of Death from March to May 2020. The rates were age standardised and adjusted to a 100% register coverage and compared with a 95% prediction interval (PI) from linear regression based on corresponding rates for 2010–2019.Results113 710 deaths were included, of which 10 226 were from 2020. We did not observe any deviation from predicted total mortality. There were fewer than predicted deaths from chronic lower respiratory diseases excluding asthma (11.4, 95% PI 11.8 to 15.2) and from other non-ischaemic, non-rheumatic heart diseases (13.9, 95% PI 14.5 to 20.2). The death rates were higher than predicted for Alzheimer’s disease (7.3, 95% PI 5.5 to 7.3) and diabetes mellitus (4.1, 95% PI 2.1 to 3.4).ConclusionsThere was no significant difference in the frequency of the major causes of death in the first wave of the 2020 COVID-19 pandemic in Norway compared with corresponding periods 2010–2019. There was an increase in diabetes mellitus and Alzheimer’s deaths. Reduced mortality due to some heart and lung conditions may be linked to infection control measures.
Protocol for thiamine and folic acid in the treatment of cognitive impairment in maintenance haemodialysis patients: a prospective, randomised, placebo-controlled, double-blind, multicentre study
Authors: Lu Renhua , Gu Le-Yi , Zhang Weiming , Guo Yongping , Zang Xiujuan , Zhou Yan , Yu Ling , Pan Shuting , Pang Huihua , Liu Shang , Xie Kewei , Li Ping , Zeng Xiaojun , Lu Yifei 
Published: December 2021

IntroductionCognitive impairment (CI) is the common complications in maintenance haemodialysis (MHD) patients. Recently, the pathogenesis of CI has been discussed and oxidative stress is one of the main mechanisms in these patients. Thiamine and folic acid, which play an important role in relieving the production of reactive oxygen species, reducing homocysteine levels, improving oxidative stress in the nervous system. In pilot study, cognitive function was significantly improved in the group with thiamine and folic supplementation. Based on this result, we hypothesise that thiamine combined with folic acid supplementation may improve cognitive function in patients with MHD.Methods and analysisIn this prospective, randomised, placebo-controlled, double-blind, multicentre study, we will enrol patients undergoing haemodialysis who has the Montreal Cognitive Assessment score lower than 26 to treatment group (thiamine 90 mg/day combined with folic acid 30 mg/day) or control group (thiamine placebo 90 mg/day combined with folic acid placebo 30 mg/day). All subjects will be followed up for 96 weeks. The primary endpoint is the comparison of Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) score between treatment group and control group at 96 weeks of follow-up. The secondary endpoints include serum thiamine, folate, homocysteine levels, cranial functional MRI and survival. The central randomisation method will be adopted and the principles of placebo-controlled, double-blind randomised control will be followed. The comparisons among ADAS-Cog scores and other secondary endpoints over time within subjects is conducted by using repeated measure analysis of variance (ANOVA) or generalised estimating equations (GEE). Pairwise t-test with Bonferroni adjustment is performed for multiple comparisons. On the other hand, for comparisons between treatment and control group, simple one-way ANOVA, GEE or Wilcoxon rank sum test is used. The χ2method is used for statistical analysis of the categorical data. Kaplan-Meier survival curve is used for survival analysis. A p<0.05 is considered statistically significant difference.Ethics and disseminationThis trial has been approved by Shanghai Jiao Tong University School of Medicine, Renji Hospital Ethics Committee (KY2019-199). After publication of study results, trial report will be published in peer-reviewed journals and/or in national or international conferences.Trial registration numberChiCTR2000029297.