bluuebunny/crossref_metadata_2025_split huggingface dataset:
Electroacupuncture versus solifenacin succinate for female overactive bladder: study protocol for a multicentre, randomised, controlled, double-dummy, non-inferiority trial
Authors: Chen Bingli , Yin Ping , Li Juanjuan , Hou Wenguang , Fan Qian , Huai Yisheng , Liu Lumin , Hu Junwei , Chow Sandra Teresa , Li Xu , Ming Shuren , Chen Yue-Lai 
Published: September 2024

IntroductionOveractive bladder (OAB) affects approximately 500 million people worldwide, with a higher prevalence in women than in men, significantly impacting the quality of life of female patients. Treatment options for OAB are currently limited. Previous research has proposed that electroacupuncture could be a viable treatment for OAB in women, but there is a lack of high-quality clinical evidence. This study aims to evaluate the effectiveness of electroacupuncture as a safe and efficient non-pharmacological treatment for female OAB by comparing it with solifenacin succinate.Methods and analysisThis study is a multicentre, single-blind, double-dummy randomised controlled non-inferiority clinical trial involving 204 eligible female participants with OAB. Participants will be randomly assigned in a 1:1 ratio to either the electroacupuncture group (receiving electroacupuncture and placebo) or the solifenacin succinate group (receiving sham electroacupuncture and solifenacin succinate). Each participant will undergo 12 sessions of electroacupuncture (or sham electroacupuncture) treatment and solifenacin succinate (or placebo) treatment over a 4-week period. The primary outcome measure will be the percentage change in the number of micturition episodes every 24 hours at week 4 compared with baseline. Secondary outcomes will include a percentage reduction in the number of micturition episodes every 24 hours at 2th, 8th and 16th weeks of the trial, Overactive Bladder Symptom Score, number of urinary incontinence and urgency episodes every 24 hours based on a 3-day voiding diary, OAB Questionnaire, Generalised Anxiety Disorder Scale-7, King’s Health Questionnaire and Participant Self-evaluation of Therapeutic Effects. Adverse events will be monitored throughout the study. Efficacy analyses will be conducted on both the intention-to-treat population and the per-protocol set population.Ethics and disseminationEthical approval has been obtained from the Medical Ethics Committee of Longhua Hospital Shanghai University of Traditional Chinese Medicine (approval number: 2022LCSY097). Each participant will sign a written informed consent before randomisation. The results of this study will be published in a peer-reviewed journal.Trial registration number NCT05798403.
Protocol for a clinically annotated biorepository of samples from Australian immune-compromised patients to investigate the host–microbiome interaction
Authors: Smibert Olivia C , Trubiano Jason A , Kwong Jason C , Markey Kate A , Slavin Monica A 
Published: September 2024

IntroductionThe human gut microbiota has the potential to modulate the outcomes of several human diseases. This effect is likely to be mediated through interaction with the host immune system. This protocol details the establishment of a biorepository of clinically annotated samples, which we will use to explore correlations between the gut microbiota and the immune system of immune-compromised patients. We aim to identify microbiome-related risk factors for adverse outcomes.Methods and analysesThis is a protocol for the development of a biorepository of clinically annotated samples collected prospectively across three centres in Melbourne, Australia. Participants will be recruited across the following clinical streams: (1) acute leukaemia and allogeneic stem cell transplant; (2) end-stage liver disease and liver transplant; (3) patients receiving any cancer immunotherapies (eg, chimeric antigen receptor therapy); (4) deceased organ donors and (5) healthy adult controls. Participants will be asked to provide paired peripheral blood and microbiota samples (stool and saliva) at either (1) single time point for healthy controls and deceased organ donors or (2) longitudinally over multiple prespecified or event-driven time points for the remaining cohorts. Sampling of fluid from bronchoalveolar lavage and colonoscopy or biopsy of tissues undertaken during routine care will also be performed.Ethics and disseminationEthical approval has been obtained from the relevant local ethics committee (The Royal Melbourne Hospital Human Research Ethics Committee). The results of this study will be disseminated by various scientific platforms including social media, international presentations and publication in peer-reviewed journals.Trial registration numberACTRN12623001105639. Date registered 20 October 2023.
Effects of yoga compared with health promotion on health-related quality of life in adults with post-COVID-19 condition: protocol for a randomised controlled trial
Authors: Brodén Mikaela , Welfordsson Paul , Niemi Maria , Diwan Vinod , Shah Komal , Pattanadara Vijayakumar , Hallgren Mats 
Published: September 2024

IntroductionPost-COVID-19 condition (post COVID, also known as long COVID) is a global public health issue estimated to affect over 100 million people. Common symptoms include fatigue, dyspnoea and cognitive dysfunction (‘brain fog’). Over time, these symptoms have an adverse effect on mental health, physical activity and quality of life (QoL). The condition requires innovative and feasible treatment approaches that can be effective and self-managed. Physical activity is essential for good health; however, aerobic exercise or weightlifting may not be suitable for post COVID patients who experience fatigue or breathlessness. The benefits of yoga include improved flexibility, mobility, body strength and balance. It is also shown to reduce symptoms of fatigue and improve breathing efficiency, mental health and QoL. This study protocol describes the rationale and methods for a randomised controlled trial (RCT) of a yoga-based intervention designed for adults with post COVID.Methods and analysisA two-group, parallel, RCT with blinded follow-up assessments. Participants will be randomised with a 1:1 allocation to either a 12-week yoga-based intervention or a 12-week health promotion (active comparison) intervention. In total, 88 participants aged 30–65 years will be recruited and randomised. The primary outcome is health-related QoL (36-item Short-Form). Secondary outcomes are dyspnoea, fatigue, sleep quality, cognitive functions, mental fatigue, depression, anxiety, physical activity, demographic data and physical health measures. Data will be analysed as intention-to-treat basis, using linear mixed modelling. All assessments are conducted at Karolinska Institutet in Stockholm, Sweden. The yoga-based intervention will take place at a yoga studio centrally located in Stockholm city.Ethics and disseminationThe study is approved by the Swedish Ethical Review Authority, reference number 2023/06518-01. All participants must sign written informed consent before enrolment and are free to withdraw from the study at any point. Key results will be available through research articles and seminars.Trial registration numberGerman Clinical Trials Register, DRKS00032837.
Fatherhood and men’s participation in antenatal care in rural sub-Saharan Africa: a scoping review protocol
Authors: Musiwa Anthony Shuko , Mavhu Webster , Nyamwanza Owen , Chadambuka Elizabeth , Couban Rachel , Mbuagbaw Lawrence 
Published: September 2024

IntroductionMen’s participation is imperative for improving antenatal care (ANC) access and mother and child health outcomes in sub-Saharan Africa (SSA). Research looking at improving men’s participation in ANC often focuses on their instrumental and psychosocial roles and on biomedical ANC systems. There is limited understanding of how context-specific cultural experiences of fatherhood influence men’s participation in ANC within broader communal support networks and across different ANC systems in SSA. Against this background, and to understand how local communities in SSA conceive men’s participation in ANC, a scoping review will be undertaken to synthesise existing literature around local cultural experiences of fatherhood and men’s participation in ANC in rural settings in SSA.Methods and analysisThe classical scoping review methodology developed by Arksey and O’Malley will be used to conduct the scoping review described above. Empirical studies published between 1 January 2000 and 31 August 2024 will be systematically searched for in key online databases (eg, PubMed/MEDLINE, CINAHL, EMBASE, PsycINFO, Cochrane Library, African Index Medicus, African Journals Online) and grey literature (eg, reports from key organisations like UNICEF and the WHO). Literature reviews, personal opinion articles and theoretical or conceptual articles that do not systematically analyse data, and non-English texts, will be excluded. Data will be extracted from the included texts in the form of study characteristics, which will be analysed using descriptive statistics, and key issues to be analysed thematically.Ethics and disseminationNo ethical approvals are needed for this scoping review since data will be abstracted from already-published literature and no additional data will be collected. The findings will be shared with policymakers, practitioners, researchers, students and local communities through peer-reviewed journal publication(s), conference presentations, public lectures and policy-focused stakeholder and community meetings in and outside SSA.
Informal carer involvement in the transition of medicines-related care for patients moving from hospital to home: a realist review protocol
Authors: Cooper Matthew , Atkinson Olivia , Black David , Lindsey Laura , Cooper Christina , Nazar Hamde , Wong Geoff , Hughes Carmel , Richardson Charlotte L 
Published: September 2024

IntroductionTransition of care for a patient between hospital and home can cause disruption to normal routines, increasing the risk of medicines-related harm. The transition from hospital to home is more complex when a patient does not self-manage their medicines but relies on an informal or unpaid carer (eg, spouse, family member or friend) to provide support. Given the day-to-day medicines-related support provided by informal carers, there is a need to understand how informal carers manage the transition of care from hospital to home; what aspects of hospital discharge act as barriers and facilitators to their involvement and when, how and why these impact patients.Methods and analysisA realist review will be undertaken to develop a programme theory. The programme theory will theorise which medicines-related interventions are useful to carers, and how they are useful. It will outline what aspects of those interventions are the most useful and why, and how context influences engagement and medicine-related outcomes. The review will be reported in line with the Realist and Meta-narrative Evidence Syntheses: Evolving Standards guidelines. Data will be selected, screened and extracted based on defined inclusion and exclusion criteria and relevance to the developing programme theory with the involvement of at least two authors acting independently. Inclusion criteria relate to the relevance to hospital discharge where patients move back to their home, where a carer is involved and where interventions relate to medicines use. Searches will be conducted in PubMed, CINAHL (via EBSCOhost) and EMBASE databases (see supplementary materials for a draft search strategy).Patients and public, participation, involvement and engagement (PPIE) will be incorporated into all stages of the review through iterative engagement and discussion with patient, carers and representatives from carer organisations. The review will follow four steps: (1) development of the initial programme theory, (2) evidence search, (3) selection, extracting, and organising data and (4) synthesising evidence and drawing conclusions.Informal carer involvement in transitions of care is a complex and varied phenomena. The programme theory will be shaped by sustained PPIE reflecting the priorities and experiences of lived experience. The realist review be progressively focused so we can develop a better understanding of carer involvement in patient transitions when moving from hospital to home relating to medicines use.Ethics and disseminationEthical approval is not required. The findings of the review will be disseminated via journal articles and through patient and public facing resources such as a visual patient–public-carer focused summary.PROSPERO registration numberCRD42021262827.
Identification of PRMT5 as a therapeutic target in cholangiocarcinoma
Authors: Elurbide Jasmin , Colyn Leticia , Latasa Maria U , Uriarte Iker , Mariani Stefano , Lopez-Pascual Amaya , Valbuena Emiliana , Castello-Uribe Borja , Arnes-Benito Robert , Adan-Villaescusa Elena , Martinez-Perez Luz A , Azkargorta Mikel , Elortza Felix , Wu Hanghang , Krawczyk Marcin , Schneider Kai Markus , Sangro Bruno , Aldrighetti Luca , Ratti Francesca , Casadei Gardini Andrea , Marin Jose J G , Amat Irene , Urman Jesus M , Arechederra Maria , Martinez-Chantar Maria Luz , Trautwein Christian , Huch Meritxell , Cubero Francisco Javier , Berasain Carmen , G Fernandez-Barrena Maite , Avila Matias A 
Published: September 2024

BackgroundCholangiocarcinoma (CCA) is a very difficult-to-treat cancer. Chemotherapies are little effective and response to immune checkpoint inhibitors is limited. Therefore, new therapeutic strategies need to be identified.ObjectiveWe characterised the enzyme protein arginine-methyltransferase 5 (PRMT5) as a novel therapeutic target in CCA.DesignWe evaluated the expression of PRMT5, its functional partner MEP50 and methylthioadenosine phosphorylase (MTAP)—an enzyme that modulates the sensitivity of PRMT5 to pharmacological inhibitors—in human CCA tissues. PRMT5-targeting drugs, currently tested in clinical trials for other malignancies, were assessed in human CCA cell lines and organoids, as well as in two immunocompetent CCA mouse models. Transcriptomic, proteomic and functional analyses were performed to explore the underlying antitumoural mechanisms.ResultsPRMT5 and MEP50 proteins were correlatively overexpressed in most CCA tissues. MTAP was absent in 25% of intrahepatic CCA. PRMT5-targeting drugs markedly inhibited CCA cell proliferation, synergising with cisplatin and gemcitabine and hindered the growth of cholangiocarcinoma organoids. PRMT5 inhibition blunted the expression of oncogenic genes involved in chromatin remodelling and DNA repair, consistently inducing the formation of RNA loops and promoting DNA damage. Treatment with PRMT5-targeting drugs significantly restrained the growth of experimental CCA without adverse effects and concomitantly induced the recruitment of CD4 and CD8 T cells to shrinking tumourous lesions.ConclusionPRMT5 and MEP50 are frequently upregulated in human CCA, and PRMT5-targeting drugs have significant antitumoural efficacy in clinically relevant CCA models. Our findings support the evaluation of PRMT5 inhibitors in clinical trials, including their combination with cytotoxic and immune therapies.
InvasiveNeisseria meningitidissubtype C in gay, bisexual and other men who have sex with men: a systematic review
Authors: Rabuszko Lucy , Stuart-George Sarah , Chessell Callum , Fitzpatrick Colin , Williams Deborah , Richardson Daniel 
Published: September 2024

IntroductionOutbreaks of invasiveNeisseria meningitidissubtype C in networks of gay, bisexual and other men who have sex with men (MSM) have been reported. We aimed to explore any factors seen in MSM with invasiveN.meningitidissubtype C.MethodWe searched three bibliographical databases for manuscripts written in English exploring at least one factor seen in MSM with invasiveN. meningitidissubtype C published up to May 2024. Following an initial search, removal of duplicates and abstract review, two authors independently reviewed full-text manuscripts and performed a risk of bias assessment using the Joanna Briggs Institute toolkit. Narrative data were synthesised to generate themes.Results16 manuscripts were included in this review from the USA (n=10), Germany (n=2), France (n=2), Canada (n=1) and Italy (n=1) and consisted of nine case series, four cross-sectional studies, two case reports and one case–control study published between 2003 and 2024 involving 236 MSM with invasiveN. meningitidissubtype C, of which at least 64 died. We have highlighted some demographic (African-American or Hispanic identity in the USA, living with HIV), behavioural (kissing, sharing drinks, visiting sex-on-premises venues, visiting gay-oriented venues, using websites/mobile phone apps to meet sexual partners, recreational drug use, multiple and non-regular sexual partners) and infection (previousChlamydia trachomatis, Treponema pallidum, Neisseria gonorrhoeae, Mpox) factors in MSM with invasiveN. meningitidissubtype C.ConclusionThese data serve as an important resource to inform and target future public health strategies and outbreak control measures for the prevention of invasiveN. meningitidissubtype C in MSM.PROSPERO registration numberCRD42024543551.
Introduction
Authors: Rudy Kathryn M. 
Published: September 2024

This book explores the interactions between medieval manuscripts and their users in late medieval Europe, where touching held significant religious and social charge. In contrast to previous scholarship on medieval manuscripts, this book ignores pristine, untouched manuscripts and concentrates instead on those bearing the marks of frequent handling. The underlying argument is that studying marks of wear reveals the functions of books, and to some degree, their owners’ habits and emotions.
The study dissects the curative and communal aspects of touching, historically rooted in the veneration of relics, which could transmit divine power through proximity and belief. This reverence for touch extended to manuscripts, especially Gospel books, which were considered conduits of divine power. Such manuscripts functioned as practical tools integral to social rituals and community cohesion.
Volume 1 established the divinity of the book-object and its role in Christian rituals, while the current volume expands on the social dynamics of touched manuscripts. Volume 2 highlights three themes: the use of images to enhance public speaking, the moralizing role of the speaker, and the pivotal role of touch in fostering community through books. Volume 2 refines the taxonomy, introduced in Vol. 1, to differentiate between inadvertent from targeted wear and to further identify habits of touch under the latter category. These include intentional interactions with the text and images, such as wet-touching, dramatically gesturing with the finger, aggressive poking, and wiping with a cloth, each revealing the intentions and emotions behind the contact. The method—use-wear analysis—infers the specific gestures based on the marks made on manuscripts, which, whether through wet-touching or dramatic pointing, signify different forms of interaction and intention. The study considers the impact of these practices on the manuscripts themselves, which, when touched, kissed, or manipulated, not only served their utilitarian purpose but also became actors in the rituals they facilitated.
Manuscripts were adapted to serve as instruments of social cohesion. The study explores the taxonomy of touching, where manuscripts in various forms - from charters to codices - were used in educational settings, courtly environments, and religious communities to establish identity, authority, and communal bonds through deliberate touch and handling.
Chapter 1
Authors: Rudy Kathryn M. 
Published: September 2024

This chapter examines the evolution of rituals for establishing social bonds and hierarchies in medieval Europe, focusing on the transformation from oral professions of obedience to formalized, written vows. It explores the adaptation of these rituals from the eighth to the fifteenth century, highlighting how ecclesiastical and civic organizations utilized the potent combination of spoken words, manual gestures, and the handling of documents to maintain order and allegiance.
Lanfranc, the Archbishop of Canterbury, systematized professions of obedience, which were initially personalized and then gradually became more formulaic. These professions, initially linked to the church's ecclesiastical hierarchy, eventually extended to include laypeople and took on the characteristics of labor contracts.
A shift in practice occurred as these professions transitioned from charters to codices, and from England to the Continent, reflecting changes in medium and ritual. Professions moved from individualized performances at the altar to collective experiences, with the Gospel manuscript emerging as a central prop in the oath-taking process, lending a theatrical and divine aspect to the rituals. The chapter finishes by analyzing the individual profession charters made by sixteenth-century nuns in the Netherlands: they reinvent the model used eight centuries earlier in Canterbury.
Conclusion
Authors: Rudy Kathryn M. 
Published: September 2024

The final chapter considers the social significance of book handling in medieval manuscripts, highlighting models of gesture transmission that fostered social bonds. These models include ritualistic actions required by religious scripts, behaviors modeled by authorities, and behaviors shaped by figures such as teachers. These are all vertical forms of behavior transmission. Horizontal forms include haptic habits that transfer across contexts (at a macro level), and members of peer groups who emulate each other’s behavior (at a micro level). Finally, some interactions are dictated by the physical demands of the book object itself.
The study has emphasized the physicality of medieval book interaction, where filling in blanks or adding inscriptions was not just a clerical task but a socially binding act, connecting the past with the future through living continuity. The text investigates the ritualized nature of book handling, with authority figures modeling book interaction that trickled down through social hierarchies, becoming embedded in various rituals and thereby spreading to broader lay and religious communities.
A manuscript's marks of wear provide historical evidence of its use, supporting the argument that certain gestures, like touching book initials, had social and performative roles, enhancing the experiential aspect of reading and group participation. The chapter posits that touching an initial could signify the initiation of reading, veneration, or a demonstration to an audience. It proposes that these gestures, while evolving over time and contexts, have left enduring marks on the physical and cultural fabric of book history.
In the afterword, the author invites alternate interpretations and evidence, aiming to deepen the understanding of medieval manuscript reception and user interaction. The legacy of these book-touching behaviors persists in contemporary rituals, such as oath-taking, albeit with modern adaptations reflecting current societal norms and knowledge, such as hygiene concerns or secular values.