bluuebunny/crossref_metadata_2025_split huggingface dataset:
Hepatic arterial infusion chemotherapy plus regorafenib compared with regorafenib alone as second-line therapy for advanced hepatocellular carcinoma: a randomised controlled trial protocol
Authors: Zhao He , Zhang Xiaowu , Tian Pengfei , Luo Yingen , Sun Wei , Li Ying , Li Jingui , Gong Tao , Yang Zhengqiang , Song Peng , Li Xiao 
Published: December 2024

IntroductionThe exact role of hepatic arterial infusion chemotherapy (HAIC) in advanced hepatocellular carcinoma (aHCC) is still unknown. The combination of HAIC and sorafenib has been proven to be more effective than sorafenib alone in the first-line treatment of aHCC. The aim of the study is to evaluate the efficacy and safety of HAIC plus regorafenib in the second-line treatment of aHCC.Methods and analysisThis is a multicenter, open-label, randomised controlled phase III trial. A total of 294 patients with aHCC, who are unable to tolerate the first-line systemic therapy or progress after the first-line systemic therapy, will be enrolled in the study. The patients will be randomly (2:1) assigned into the combination treatment group (HAIC plus regorafenib, n=196) and the control group (regorafenib alone, n=98). HAIC and regorafenib (160 mg/day) will be given in a 4-week cycle. The primary endpoint is overall survival in the intention-to-treat population. The second endpoints include progression-free survival, overall response rate, time to progression, etc. The radiological assessments will be based on the criteria of Response Evaluation Criteria in Solid Tumors 1.1.Ethics and disseminationThis study is approved by the ethics committee of Cancer Hospital, Chinese Academy of Medical Sciences. All participants are required to provide written informed consent. The results of this study will be disseminated through peer-reviewed publications and esteemed academic conferences.Trial registration numberChinese Clinical Trial Registry (ChiCTR2300073075).
Dental caries prevalence and caries-associated risk factors of students aged 12–15 in Xide County of Liangshan Prefecture, China: a cross-sectional study
Authors: Sun Suzhen , Lou Yiting , Weng Xiaoyan , Xie Chenghui , Ma Haiying , Sun Zheyuan , Wang Qianting , Yang Yong , Ji Kaile , Ying Binbin 
Published: December 2024

ObjectiveAbout 2 billion people have caries in permanent teeth, and 514 million children have caries in primary teeth worldwide. Regional disparities in caries prevalence are evident in various areas of China. A comprehensive understanding of the status of dental caries and its associated risk factors is essential for developing effective dental health policies in economically disadvantaged regions. Thus, this study aims to examine the prevalence of dental caries and its risk factors among students aged 12–15 in Xide County, a remote mountainous area in China.DesignIn this cross-sectional study, dental health surveys were conducted using self-administered questionnaires and the Decayed-Missing-Filled Tooth (DMFT) Index. An oral clinical examination was carried out by the criteria and guidelines set forth by WHO.SettingXide County, Liangshan prefecture, China in 2022.Participants558 students aged 12–15 years completed the survey.ResultsThe study conducted in Xide County found a dental caries prevalence of 42.5% among 12–15 year-old students, with a mean DMFT of 1.50 (SD=2.25). Multivariable logistic regression analysis identified several significant risk factors for dental caries (p<0.05), including starting brushing after the age of six (OR 0.34, 95% CI 0.17 to 0.65), brushing teeth less than once a day (OR 9.24, 95% CI 5.53 to 15.33) and consuming carbonated drinks more than once a day (OR 0.28, 95% CI 0.14 to 0.53). Additionally, the use of fluoride (OR 0.61, 95% CI 0.43 to 0.85) and awareness of its protective effect on teeth (OR 0.75, 95% CI 0.59 to 0.98) were found to be associated with a lower risk of dental caries (p<0.05).ConclusionThe prevalence of dental caries among students aged 12–15 in Xide County was identified as a significant public oral health concern. The oral health behaviours of students were found to be influenced by factors at the family and community levels.
Psychological and pharmacological treatments of intermittent explosive disorder: a meta-analysis protocol
Authors: Liu Fangqing , Yin Xiaoshan 
Published: December 2024

IntroductionIntermittent explosive disorder (IED) is characterised by recurrent, sudden episodes of impulsive aggression that are disproportionate to the provocation. The condition’s management remains challenging due to the variability in treatment efficacy and the absence of Food and Drug Administration-approved interventions specifically for IED. This meta-analysis aims to evaluate the effectiveness of existing treatments for IED.Methods and analysisAdhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a comprehensive literature search was conducted in November 2023, yielding 17 randomised controlled trials after screening and eligibility assessments. Studies were included based on participants’ confirmed diagnosis of IED, sufficient statistical power and provision of data for effect size calculation. Interventions analysed included pharmacological treatments, psychotherapies and combination therapies, with an emphasis on cognitive–behavioural therapy and selective serotonin reuptake inhibitors. Quality assessment was performed using the Cochrane Risk of Bias Tool.Ethics and disseminationGiven that our study is a synthesis of published data, ethical approval from a research ethics committee is not required. Nevertheless, the methodology of this review was designed to ensure full transparency and accountability. All efforts have been made to respect the confidentiality and intellectual property rights of the original data sources. Any ethical issues encountered during the data collection process were addressed in accordance with the guidelines of the Declaration of Helsinki. As this research involves the analysis of existing published data, there are no direct safety concerns related to patient interactions. Our primary focus has been on ensuring the secure handling and processing of data to uphold the ethical standards set by previous original studies. To ensure the findings of our meta-analysis reach both the academic community and the public effectively, we aim to submit our findings to peer-reviewed journals within the fields of psychology to ensure rigorous review and broad academic dissemination.PROSPEO registration numberCRD42024497587.
Trial to compare mixed-use (multi-use and single-use) intermittent catheter management with single-use management over 12 months (The MultICath Trial): protocol for a non-inferiority randomised controlled trial
Authors: Fader Mandy , Macaulay Margaret , Wilson Nina , Goudie Nicola , Chadwick Thomas J , Abouhajar Alaa , Jones Jeremy , Watson Gillian , Avery Miriam R , Broadbridge Jackie , Buckley Brian S , Clancy Bridget , Cottenden Alan , Dickson Sylvia , Guerrero Karen , Hagen Suzanne , James Catherine P , Khasriya Rajvinder , Little Paul , May Carl R , McClurg Doreen , Moore Michael , Murphy Cathy , Prieto Jacqui , Reading Isabel , Shields Carol , Timoney Anthony , Wilks Sandra A 
Published: December 2024

IntroductionEvaluating the safety and acceptability of reusing catheters for intermittent catheterisation (IC) is one of the top 10 continence research priorities identified by the UK James Lind Alliance Priority Setting Partnership in 2008. There are an estimated 50 000 IC users in England and this number is rising. Globally, both single-use catheters (thrown away after use) and multi-use/reusable ones (cleaned between uses) are used. Using multi-use catheters as well as single-use ones (mixed-use) could bring benefits (eg, reducing plastic waste and patients never running out of catheters) and offer more choice to users. Evidence is needed that mixed-use is at least as safe and acceptable as using only single-use catheters.MethodsThe MultICath Trial is a non-inferiority randomised controlled trial involving 578 participants. The aim is to compare mixed-use catheter management with single-use catheter management over 12 months. Participants are randomised on a 1:1 basis to either mixed-use catheter management, which includes an evidence-based cleaning method for the multi-use catheters (intervention) or single-use catheter management (control). Following randomisation, participants are followed up for 12 months. The primary outcome is at least one episode of microbiologically confirmed symptomatic urinary tract infection with help-seeking or self-help behaviour over the 12-month follow-up period. Laboratory analysis of patient-initiated urine samples is blind. Secondary outcomes include antibiotic use, microhaematuria, visible blood on catheter/in urine, quality of life and health economics. A qualitative sub-study to examine participant experiences using mixed-use is included.Ethics and disseminationEthical review was undertaken by South Central-Hampshire A Research Ethics Committee and favourable opinion was granted on 12 July 2019 (reference: 19/SC/0334). Written, informed consent to participate was obtained from all participants. Results will be disseminated in peer-reviewed publications, in the National Institute for Health and Care Research journal library and to participants and the public via a lay summary published on the trial website.Trial registration numberISRCTN42028483.
Vaccination status, personal and workplace experiences of early career health professionals in the WiSDOM cohort study during the COVID-19 pandemic in South Africa
Authors: Rispel Laetitia , Ditlopo Prudence , White Janine A , Blaauw Duane 
Published: December 2024

IntroductionThe knowledge gaps on the experiences of early career health professionals during the COVID-19 pandemic informed this study, which examined their vaccination status, personal and workplace experiences in South Africa.MethodsWits longitudinalStudy toDetermine theOperation of the labourMarket among its health professional graduates (WiSDOM), a prospective longitudinal cohort study established in 2017, consists of eight health professional groups of clinical associates, dentists, doctors, nurses, occupational therapists, oral hygienists, pharmacists and physiotherapists. As a part of annual follow-up surveys, we examined the personal and workplace experiences and the vaccination status of cohort members during the COVID-19 pandemic years: 2020 until 2022. We measured workplace experiences using a Likert scale that ranged from 1 (strongly disagree) to 7 (strongly agree). We constructed a composite index of positive workplace COVID-19 support using a principal component analysis.We compared differences among the professional groups using proportions for categorical variables and means for numerical variables. We used multiple linear regression to investigate factors associated with the workplace COVID-19 support score and Firth’s penalised logistic regression for COVID-19 infection and vaccination.ResultsIn 2022, the mean age of the 363 cohort members was 28.9 (± 2.1), and the majority were female (74.2%). In 2020, 22.6% of the cohort reported COVID-19 infections but this increased to 45.3% by 2021. The composite index shows that doctors and nurses reported the lowest COVID-19 workplace support, while oral hygienists and dentists reported the most support. Although 89.5% of cohort members reported full COVID-19 vaccination status, 9.4% indicated non-intention to get vaccinated. The regression analysis showed that doctors (p<0.001) and women (p<0.05) reported significantly lower workplace COVID-19 support scores. Those working in hospitals had 17.1% higher COVID-19 infections (p<0.01). The lack of a COVID-19 supportive workplace resulted in 15.7% higher infections among early career health professionals (p<0.01).ConclusionThe study findings underscore the need for positive practice environments for early career health professionals in South Africa.
Impact of caesarean scar defects on the success of assisted human reproduction: the NICHE-ART prospective French cohort study protocol
Authors: Astruc Audrey , Deseine Delphine , Spiers Andrew , Boguenet Magalie , May-Panloup Pascale , Bouet Pierre Emmanuel , Legendre Guillaume 
Published: December 2024

BackgroundThe global increase in caesarean sections (CS), currently at 21.1% of all deliveries, has led to a rise in uterine scar defects, or ‘niches’, at the hysterotomy site. These niches, detectable in 13%–84% of cases via transvaginal ultrasound (TVS) and 42%–84% through sonohysterography (SHG), may contribute to gynaecological complications, including abnormal uterine bleeding, chronic pain and secondary infertility. Niche-associated risks for in vitro fertilisation (IVF) outcomes remain underexplored, and this study aims to evaluate their impact on clinical pregnancy rates.Methods and analysisThis multicentre, prospective, non-interventional study will involve 250 women with a history of CS and secondary infertility undergoing IVF in 14 reproductive units of French Hospital. Participants will be assessed using SHG and TVS to determine niche presence (measurements of the length, depth and width of the niche, and residual myometrial thickness (RMT)). A niche is diagnosed by an indentation of at least 2 mm at the site of the caesarean scar, with a large niche defined as RMT <3 mm. The primary outcome is clinical pregnancy rate, with secondary outcomes including live birth rates, biochemical pregnancies and obstetric complications. Multivariate logistic regression will control for confounders. The duration of the inclusion period is estimated to be 42 months.Ethics and disseminationThe study protocol was approved by the relevant French medical review board, ‘Comité de Protection des Personnes Sud Méditerranée IV’, on 10 November 2020 and recorded prospectively (before the inscription of the first participant) under the number ID-RCB: 2020-A02068-31. The study will be conducted according to the guidelines of the Declaration of Helsinki. Informed consent will be obtained from all participants. The findings will be published in peer-reviewed journals and presented at relevant meetings.Trial registration numberClinicalTrials.gov, ID:NCT04869007. Registered on 16 August 2020.
Study protocol of a randomised controlled trial of the effects of near-infrared spectroscopy neurofeedback training coupled with virtual reality technology in children with ADHD
Authors: Zheng Que , Kei Kathy Tsam-ling , Chiu Ka Yu , Shum Kathy Kar-man 
Published: December 2024

BackgroundThe rise in the number of children diagnosed with attention-deficit/hyperactivity disorder (ADHD) highlights the need for effective interventions targeting attentional control. Although recent research has demonstrated the potential of neurofeedback training (NFT) for children with ADHD, most studies have been conducted in laboratory settings, raising questions about their real-world applicability. To address this issue, virtual reality (VR) may offer a solution to the ecological validity challenges encountered in NFT. By coupling NFT with VR, individuals can engage in self-regulating brain activity within a simulated, realistic environment. This study aims to investigate the efficacy of near-infrared spectroscopy (NIRS)-based NFT combined with VR in alleviating ADHD symptoms among children, addressing the need for interventions with practical relevance and effectiveness.MethodsThis study aims to recruit 138 children aged 7–12 diagnosed with ADHD. Following baseline assessment, participants will be randomly assigned to one of three conditions: (1) NIRS-based NFT in a VR classroom setting; (2) conventional computerised cognitive training (active control) or (3) a waitlist control group. On completion of intervention sessions in the two training groups, all groups will undergo an assessment at time 2, with a follow-up assessment scheduled 2 months post-training for all participants. Primary outcomes will include measures of executive function, such as attentional control, response inhibition and working memory, along with changes in oxygenated and deoxygenated haemoglobin levels monitored by functional NIRS. Secondary outcome measures will comprise ratings of children’s ADHD symptoms and executive function behaviours in daily life, reported by parents and teachers.DiscussionThe three-arm randomised controlled trial will address research gaps regarding the effectiveness of NIRS-based NFT for children with ADHD, particularly when integrated with immersive VR technology. By combining NFT and VR, this study aims to simulate a real-world environment, potentially amplifying intervention effects. The findings from the study will provide evidence for the efficacy of this innovative intervention in improving executive function and alleviating ADHD symptoms.Ethics and disseminationEthical approval was obtained from the Human Research Ethics Committee at the University of Hong Kong (Reference: EA200247). Results will be published in peer-reviewed journals and presented at conferences.Trial registration numberNCT05906485.
Impact of physical inactivity and sedentary behaviour on functional constipation in children and adolescents: a systematic review
Authors: Adil Shanaz , Gordon Morris , Hathagoda Wathsala , Kuruppu Chandrani , Benninga Marc A , Rajindrajith Shaman 
Published: December 2024

ObjectiveLack of physical activity (PA) and sedentary behaviour (SB) have emerged as critical global health concerns in children and are believed to be associated with functional constipation (FC). The present study aims to explore this potential association.DesignA comprehensive search of PubMed, Scopus, Web of Science, Embase, Cochrane Library and PsycInfo databases was conducted through 2023 using terms related to constipation and PA and SB in ages 0–18 years. Titles and abstracts were screened against eligibility criteria. Constipation was diagnosed using Rome (II–IV) criteria. Full-text reviews were reviewed, and data were extracted. Risk of Bias in Non-randomized Follow-up Studies of Exposure quality assessment tool was used to evaluate the risk of bias of studies.Main outcome measuresWe assessed the association between lack of PA/SB and FC.ResultsA total of 2170 titles were screened. Nine studies encompassing 3849 children from six countries were included. Of these, four were community/school-based studies, one was a birth cohort, three were case series and two were hospital-based case-controlled studies. All 10 studies assessed the association between PA and FC. Only three showed an association between lack of PA and FC. Five studies evaluated the effects of SB on FC, and only two reported a positive association. The methods used to assess PA/SB differed across the studies. All nine studies included in the systematic review were rated as having high risk of bias.ConclusionsDespite numerous studies suggesting a link between insufficient PA/SB and FC, this systematic review did not uncover compelling evidence supporting such an association.
Why do healthcare workers refuse tuberculosis preventive treatment (TPT)? a qualitative study from Puducherry, South India
Authors: Subramanian Sadhana , Gnanadhas Jilisha , Sarkar Sonali , Rajaram Manju , Prakashbabu Senbagavalli , Chinnakali Palanivel 
Published: December 2024

BackgroundThe sustainable development goal (SDG) 3.3.2 prompted India to devise the National Strategic Plan 2017–2025, targeting tuberculosis (TB) eradication by 2030. The prevention pillar of this plan emphasises on Tuberculosis Preventive Treatment (TPT) for those with TB infection (TBI). Healthcare workers (HCWs), identified as one of the high-risk groups by the WHO, show a higher refusal rate for TPT. We aimed to explore the reasons for TPT refusal among the HCWs identified with TBI in Puducherry, South India during 2023.MethodsA qualitative descriptive study was conducted among 12 HCWs from a publicly funded tertiary care hospital, each with at least 5 years of experience. Participants were selected by maximum variation sampling, based on the department of work, current TBI status and subject expertise. The in-depth interviews, guided by the health belief model, lasted approximately 45 min each. Two researchers performed manual thematic analysis using the mixed approach for coding. Codes were grouped into categories and themes. Discrepancies were resolved through discussion with a third researcher, reaching a consensus.ResultsThree overarching themes emerged: perceived threats, beliefs regarding health interventions and empowering factors. Perceived threat elucidated the lower perceived vulnerability of contracting TB and minimal chance for progression of TBI to TB disease despite having continuous exposure and uncertainties in the workplace. Beliefs about health interventions included perceived obstacles and advantages, such as testing challenges and lack of awareness, as well as the benefits of prophylaxis and infection control measures. Empowering factors centred on prompting action and self-confidence, highlighting strategies to encourage TBI testing through administrative actions and endorsing shorter treatment plans.ConclusionsAddressing the identified knowledge gaps and false perception through targeted interventions, healthcare institutions can improve TPT uptake. Implementing a comprehensive strategy that combines hospital policies to initiate screening and treatment, a supportive environment and shorter TPT regimens is essential to prevent TB among HCWs.
‘Mental heAlth and well-being in rUgby pLayers’ (MAUL) study: an online survey of diverse cohorts of rugby union players internationally
Authors: Griffin Steffan , Syed Sheriff Rebecca , Dane Kathryn , Myall Kearnan , Simpson Kaitlin , Lewis Heather , Yeomans Caithriona , Patricios Jon , Kemp Simon , Khan Karim , Palmer Debbie , Fawkner Samantha , Kelly Paul 
Published: December 2024

IntroductionMental health and well-being is a relatively under-researched area in rugby, especially outside the elite men’s game. Evidence suggests that physical activity and sports benefit mental health and well-being, and rugby provides health-enhancing moderate-to-vigorous physical activity.ObjectiveThis cross-sectional study used an online approach and engaged national rugby governing bodies to understand adult rugby players’ mental health and well-being and increase the diversity of the current evidence base.Results500 rugby players completed an online survey. 44% of participants identified as female, and 55% as male. The UK (67%), Ireland (15%) and South Africa (12%) were the countries with the highest representation. 71% of participants were amateur players, with elite players making up 20% of the population. 87% of players participated in contact forms of the game, with 9% predominantly playing non-contact rugby. Over 50% of participants reported that rugby impacted ‘extremely’ positively on both their mental health and well-being. Based on the Kessler psychological distress scale (K10), 57.8% of all respondents belonged to the ‘psychologically well’ group. Males were more likely to belong to this group than females (p=0.01). Non-contact and amateur players had lower scores of psychological distress than contact and professional players (p=0.001 and p=0.006), respectively. Non-contact players had higher well-being (Short Warwick-Edinburgh Mental Well-being Scale) scores than contact players (p<0.001).ConclusionThis study provides new insights into the mental health and well-being of a diverse group of rugby players.