bluuebunny/crossref_metadata_2025_split huggingface dataset:
Design of TOLERANT: phase I/II safety assessment of intranodal administration of HSP70/mB29a self-peptide antigen-loaded autologous tolerogenic dendritic cells in patients with rheumatoid arthritis
Authors: Stoppelenburg Arie Jan , Schreibelt Gerty , Koeneman Bouke , Welsing Paco , Breman Evert-Jan , Lammers Laureen , de Goede Anna , Duiveman-de Boer Tjitske , van Eden Willem , Leufkens Paul , de Vries I Jolanda M , Broere Femke , van Laar Jacob M 
Published: September 2024

IntroductionIn rheumatoid arthritis (RA), immunosuppressive therapies may achieve symptomatic relief, but do not induce long-term, drug-free remission. Meanwhile, the lifelong use of immunosuppressive drugs confers increased risk for malignancy and infections. As such, there is an unmet need for novel treatments that selectively target the pathogenic immune response in RA by inducing tolerance to autoantigens. Autologous cell therapy using antigen-loaded tolerogenic dendritic cells (tolDCs) aims to reinstate autoantigen-specific immunological tolerance in RA and could potentially meet this need.Methods and analysisWe report here the design of the phase I/II, investigator-initiated, open-label, dose-escalation trial TOLERANT. In this study, we will evaluate the intranodal administration of tolDCs in patients with RA that are in remission under immunosuppressive therapy. The tolDCs in this trial are loaded with the heat shock protein 70-derived peptide mB29a, which is an effective surrogate autoantigen in animal models of arthritis. Within this study, three dose-escalation cohorts (two intranodal injections of 5×106, 10×106and 15×106tolDCs), each consisting of three patients, are evaluated to identify the highest safe dose (recommended dose), and an extension cohort of nine patients will be treated with the recommended dose. The (co-)primary endpoints of this study are safety and feasibility, which we assess by the number of AEs and the successful production of tolDCs. The secondary endpoints include the immunological effects of the treatment, which we assess with a variety of high-dimensional and antigen-specific immunological assays. Clinical effects are exploratory outcomes.Ethics and disseminationEthical approval for this study has been obtained from the Netherlands Central Committee on Research Involving Human Subjects. The outcomes of the trial will be disseminated through publications in open-access, peer-reviewed scientific journals, scientific conferences and to patient associations.Trial registration numbersNCT05251870; 2019-003620-20 (EudraCT); NL71296.000.20 (CCMO register).
Developing films to support vaccine-hesitant, ethnically diverse parents’ decision-making about the human papillomavirus (HPV) vaccine: a codesign study
Authors: Fisher Harriet , Denford Sarah , Chantler Tracey , Audrey Suzanne , Finn Adam , Hajinur Huda , Hickman Matthew , Mounier-Jack Sandra , Roderick Marion , Tucker Leanne , Yates Julie , Mohamed Asha 
Published: September 2024

ObjectiveTo illustrate an evidence-, theory- and person-based approach to codesign the COMMUNICATE films that support parental decision-making about the human papillomavirus (HPV) vaccine for their teenagers.DesignCodesign study.SettingLocalities covered by two immunisation teams in London and the south-west of England.MethodsThe intervention planning phase involved combining evidence from a literature review with qualitative interview data to identify barriers and facilitators to HPV vaccine uptake, as well as design features that should be incorporated within the COMMUNICATE films. The intervention development phase involved identifying guiding principles for the COMMUNICATE films, mapping behaviour change techniques onto the behaviour change wheel and codesigning the COMMUNICATE films. Feedback from users informed modifications to maximise acceptability and feasibility and to support behaviour change.ResultsThe primary and secondary evidence highlighted important content to include within the COMMUNICATE films: emphasise the benefits of the HPV vaccine, provide transparent information about the safety profile and side effects and emphasise the universality and commonality of HPV infection. A series of scripts were used to guide 4 film shoots to create the content in multiple community languages with 16 participants, including vaccine-hesitant, ethnically diverse parents and professionals. Overall, participants were positive about the films. Potential messengers and ways the films could be distributed, identified by parents, include local social media networks or text messages from general practices. The need for information about the HPV vaccine to be shared by schools ahead of consent being sought was also raised.ConclusionsBy using an integrated approach to intervention development, this study has begun to address the need for an intervention to support vaccine-hesitant, ethnically diverse parents’ decision-making about the HPV vaccination programme. A future study to codesign, implement and evaluate a communication strategy for the COMMUNICATE films is planned.
Association of housing status and cancer diagnosis, care coordination and outcomes in a public hospital: a retrospective cohort study
Authors: Decker Hannah , Colom Sara , Evans Jennifer L , Graham-Squire Dave , Perez Kenneth , Kushel Margot , Wick Elizabeth , Raven Maria C , Kanzaria Hemal K 
Published: September 2024

ObjectivesCancer is a leading cause of death in unhoused adults. We sought to examine the association between housing status, stage at diagnosis and all-cause survival following cancer diagnosis at a public hospital.DesignRetrospective cohort study examining new cancer diagnoses between 1 July 2011 and 30 June 2021.SettingA public hospital in San Francisco.ExposureHousing status (housed, formerly unhoused, unhoused) was ascertained via a county-wide integrated dataset that tracks both observed and reported homelessness.MethodsWe reported univariate analyses to investigate differences in demographic and clinical characteristics by housing group. We then constructed Kaplan-Meier curves stratified by housing group to examine unadjusted all-cause mortality. Finally, we used multivariable Cox proportional hazards models to compare the hazard rate of mortality for each housing status group, adjusting for demographic and clinical factors.ResultsOur cohort included 5123 patients with new cancer diagnoses, with 4062 (79%) in housed patients, 623 (12%) in formerly unhoused patients and 438 (9%) in unhoused patients. Unhoused and formerly unhoused patients were more commonly diagnosed with stage 4 disease (28% and 27% of the time, respectively, vs 22% of housed patients). After adjusting for demographic and clinical characteristics, unhoused patients with stage 0–3 disease had a 50% increased hazard of death (adjusted HR (aHR) 1.5, 95% CI 1.1 to 1.9; p<0.004) as did formerly unhoused patients (aHR 1.5, 95% CI 1.2 to 1.9; p=0.001) compared with housed individuals 3 months after diagnosis.ConclusionsUnhoused and formerly unhoused patients diagnosed with non-metastatic cancer had substantially increased hazards of death compared with housed patients cared for in a public hospital setting. Current or former lack of housing could contribute to poor outcomes following cancer diagnoses via multiple mechanisms.
Hospitalised infections and rituximab administration among children and adolescents with systemic lupus erythematosus from 2009 to 2021
Authors: Roberts Jordan E , Faino Anna V , Bryan Mersine A , Cogen Jonathan D , Morgan Esi M 
Published: September 2024

BackgroundRituximab is associated with high infection rates, but studies of infections following rituximab in youth with childhood-onset SLE (cSLE) are limited. We conducted a retrospective longitudinal cohort study to assess the incidence of hospitalised infections following rituximab among children with cSLE and to assess changes in hospital-based rituximab administration over time.MethodsYouth ages 2–21 years with an International Classification of Diseases (ICD) code for SLE who received rituximab during admission to a Pediatric Health Information System hospital from 2009 to 2021 were included. Incidence rates for infections requiring hospitalisation over the 12 months following first rituximab administration were calculated. Rituximab use by year of hospital discharge was tabulated.ResultsWe identified 1567 children with cSLE who received rituximab. 219 children were admitted with an infection within 1 year after first rituximab administration, for an incidence rate of 140 cases per 1000 patient-years. Seven children (0.44%) died during a hospitalisation with an infection in the year following rituximab administration. The most common hospitalised infections were bacterial pneumonia, sepsis and cellulitis. 12 children were hospitalised with COVID-19, none of whom died. Hospitalisations with rituximab administered decreased from 2019 to 2021.ConclusionsIn this cohort of patients with cSLE who received inpatient treatment with rituximab, we observed a 14% rate of hospitalisation with infection in the year following rituximab administration among youth with cSLE. Rituximab use declined during the COVID-19 pandemic. No fatalities with COVID-19 were observed. Given the lack of outpatient data, including doses of concomitant medications and disease activity measures, further research is needed to identify risk factors for infection following rituximab among children with cSLE.
Topological structural characteristics in patients with systemic lupus erythematosus with and without neuropsychiatric symptoms
Authors: Ao Feng , Su Li , Duan Yunyun , Huang Jing , Qiu Xiaolu , Xu Jun , Zeng Xiaofeng , Zhuo Zhizheng , Liu Yaou 
Published: September 2024

PurposeThis study investigated the topological structural characteristics of systemic lupus erythematosus (SLE) with and without neuropsychiatric symptoms (NPSLE and non-NPSLE), and explore their clinical implications.MethodsWe prospectively recruited 50 patients with SLE (21 non-NPSLE and 29 NPSLE) and 32 age-matched healthy controls (HCs), using MRI diffusion tensor imaging. Individual structural networks were constructed using fibre numbers between brain areas as edge weights. Global metrics (eg, small-worldness, global efficiency) and local network properties (eg, degree centrality, nodal efficiency) were computed. Group comparisons of network characteristics were conducted. Clinical correlations were assessed using partial correlation, and differentiation between non-NPSLE and NPSLE was performed using support vector classification.ResultsPatients with oth non-NPSLE and NPSLE exhibited significant global and local topological alterations compared with HCs. These changes were more pronounced in NPSLE, particularly affecting the default mode and sensorimotor networks. Topological changes in patients with SLE correlated with lesion burdens and clinical parameters such as disease duration and the systemic lupus international collaborating clinics damage index. The identified topological features enabled accurate differentiation between non-NPSLE and NPSLE with 87% accuracy.ConclusionStructural networks in patients SLE may be altered at both global and local levels, with more pronounced changes observed in NPSLE, notably affecting the default mode and sensorimotor networks. These alterations show promise as biomarkers for clinical diagnosis.
OnabotulinumtoxinA in Resistant Depression: A Randomized Trial Comparing Two Facial Injection Sites (OnaDEP Study)
Authors: Ceolato-Martin Caroline , Chevallier-Collins Claire , Clément Jean-Pierre , Charles Eric , Lacroix Aurélie , Ranoux Danièle 
Published: September 2024

Background: OnabotulinumtoxinA (OnaA) injection in glabella area appears to be a promising treatment for major depression. However, one major concern of placebo‐controlled studies on botulinum toxin injections is to ensure adequate blinding.Patients and Methods: In this context, all subjects of this trial received the active product (OnaA). After randomization, 58 patients with resistant major depressive disorder (MDD) received OnaA either in the glabella area (N = 29) or in the crow’s feet area (N = 29). Subjects were blinded to the supposedly effective area against resistant depression and the examiner was not aware of the injected area. The primary outcome measure was the proportion of responders (50% or greater decrease in MADRS [Montgomery and Asberg Depression Rating Scale] score from baseline) in glabella group versus crow’s feet group at week 6 after the OnaA injection.Results: The number of responders was significantly higher in the glabella group than in the crow’s feet group with 13 responders out of 29 patients (44.8%) in the glabella group and five out of 28 patients (17.9%) in the crow’s feet group (p = 0.029). The rate of psychomotor agitation as measured by item 9 of the Hamilton Depression Rating Scale (HAM‐D), associated with a shorter span of psychiatric disorder, was a potent positive predictive factor of positive response to treatment.Conclusion: We conclude that OnaA injected in the glabella muscles is an effective and well‐tolerated treatment for MDD. We suggest that patients with a high score at item 9 of the HAM‐D might be a subgroup of best responders. We assume that OnaA may act as a modulator of the activity of the primary sensorimotor cortex and then of the amygdala.Trial Registration: ClinicalTrials.gov identifier: NCT03484754
Applied Legal Hermeneutics in 18th-Century Fes: Al-Tāwudī’s Treatise on the Effect of Long Duration in bayʿ al-thunyā Transactions
Authors: Oberauer Norbert 
Published: September 2024

Abstract
The present study is an analysis of a treatise (risāla) by the 18th-century Mālikī al-Tāwudī in which he discusses a doctrinal detail regarding bayʿ al-thunyā, a common stratagem to circumvent the prohibition of interest. I use al-Tāwudī’s text as a lens to reconstruct the hermeneutical perspective of a Muslim jurist of the late premodern era. In the first section, I show that al-Tāwudī’s legal reasoning is strongly informed by the legacy of Mālikī discourse on bayʿ al-thunya, which is one of constant disagreement over the acceptability of the institution. In the course of this conflict, various doctrinal compromises were negotiated, only to be challenged again by the invention of new stratagems or by rigorist backlashes. Al-Tāwudī’s treatise must be understood as part of this doctrinal tug of war.
In the second section, I analyze al-Tāwudī’s epistemological premises. I show that his legal reasoning is strictly exegetical, except that the object of this exegesis is not Qurʾān and Sunna, as proposed in classical uṣūl al-fiqh, but the school’s literary corpus. This corpus, in turn, is hierarchically structured. It consists of many layers of texts, accumulated over centuries and tightly interwoven by intertextual references, with certain texts enjoying a particularly authoritative status. Against this background, reasoning becomes a game of artful referencing. Successful argumentation requires claiming a maximum of authority within the school tradition in support of one’s position.
Determining the Realm of the Dead through Metaphors: The Case of Gilgameš, Enkidu, and the Netherworld
Authors: Apostel Lilith , Krech Volkhard 
Published: September 2024

Abstract
In this article we provide a contribution to answering the question of how religious communication is possible. Religious communication is confronted with the essential paradox that statements about a principally inaccessible transcendence have to be made by immanent, known means. Metaphors, which we understand as mapping of a known source domain onto an unknown target domain, are particularly suitable for this purpose. We apply these assumptions to the Sumerian story Gilgameš, Enkidu, and the Netherworld to examine how the text is to be understood as religious communication. We identify the familiar physical and social spheres as the source domains and the netherworld as the unknown target domain. We show how the conceptual metaphor The netherworld is a physical place is elaborated by means of different slots, namely where the realm of the dead is located, how to get to and how to return from there, in which shape one is able to return from the netherworld, as well as how things are ordered there.
In Between Human–Animal Bodies: Transcorporeal Experiences in Hittite Anatolia
Authors: Della Casa Romina 
Published: September 2024

Abstract
This study traces material movement across human–nonhuman animal bodies (henceforth human–animal) during ritual performances in which patients from Hittite Anatolia spat into an animal’s mouth. It explores the transference of pollution through the lens of theoretical approaches that reflect on bodily margins and orifices as potent symbolic points of human bodies, as well as on bodily fluids as substances that can threaten inside/outside, subject/object distinctions. An examination of Hittite compositions from this theoretical perspective suggests that ritual patients were able, through spitting, and spittle, to release evils characterized primarily by being in between corporeality, social, and divine encounters, instead of freeing them principally from physical afflictions.
Apocalyptic Actors and Historical Trajectories in Mythic Discourse of Conspiracism
Authors: Saarinen Toni 
Published: September 2024

Abstract
Contemporary conspiracism draws on both long-standing traditions and the current cultural and political environment as it constructs mythic knowledge that often includes apocalyptic prophecies. Such knowledge is constantly altered and reinterpreted by the conspiracy activists who invest in its transmission and reproduction. This article examines how conspiracist mythologies emerge in the use of these activists as mythic discourse that fluidly adapts both to include past sources and to comment on late modern phenomena. Illustrative cases of Christian and popular millennial conspiracist narratives are analyzed in terms of how they construct the actors, organizations, power positions, and historical trajectories of the world. The article highlights how different conspiracist myths share features and stances, influenced by the currents of late modernity, but also contest each other based on what their sources and purposes are, and how they differ in their evaluation of the apocalyptic event’s nature.
Apolipoprotein E E3/E4 genotype is associated with an increased risk of coronary atherosclerosis in patients with hypertension
Authors: Wei Guoliang , Li Bin , Wang Hao , Chen Li , Chen Wenhao , Chen Kehui , Wang Weihong , Wang Shen , Zeng Hui , Liu Yuanliang , Zeng Yue , Rao Hui 
Published: September 2024

Abstract
Objective
Apolipoprotein E (APOE) gene polymorphisms were associated with coronary atherosclerosis and hypertension. However, the relationship between APOE polymorphisms and coronary atherosclerosis susceptibility in hypertensive patients is unclear. The aim of this study was to assess the relationship.

Methods
A total of 1713 patients with hypertension who were admitted to Meizhou People’s Hospital from November 2019 to August 2023 were retrospectively analyzed, including 848 patients with coronary atherosclerosis and 865 patients without coronary atherosclerosis. The rs429358 and rs7412 polymorphisms of APOE were genotyped, and relationship between APOE polymorphisms and the risk of coronary atherosclerosis in hypertensive patients were analyzed.

Results
There were 10 (0.6%), 193 (11.3%), 30 (1.8%), 1234 (72.0%), 233 (13.6%), and 13 (0.8%) individuals with APOE ɛ2/ɛ2, ɛ2/ɛ3, ɛ2/ɛ4, ɛ3/ɛ3, ɛ3/ɛ4, and ɛ4/ɛ4 genotype, respectively. The frequency of APOE ɛ3/ɛ4 was higher (16.4% vs. 10.9%, p = 0.001) in the patients with coronary atherosclerosis than controls. Logistic analysis showed that body mass index (BMI) ≥ 24.0 kg/m2 (24.0 kg/m2 vs. 18.5–23.9 kg/m2, odds ratio (OR): 1.361, 95% confidence interval (CI): 1.112–1.666, p = 0.003), advanced age (≥ 65/<65, OR:1.303, 95% CI: 1.060–1.602, p = 0.012), history of smoking (OR: 1.830, 95% CI: 1.379–2.428, p < 0.001), diabetes mellitus (OR: 1.380, 95% CI: 1.119–1.702, p = 0.003), hyperlipidemia (OR: 1.773, 95% CI: 1.392–2.258, p < 0.001), and APOE ɛ3/ɛ4 genotype (ɛ3/ɛ4 vs. ɛ3/ɛ3, OR: 1.514, 95% CI: 1.133–2.024, p = 0.005) were associated with coronary atherosclerosis in hypertensive patients.

Conclusions
Overweight (BMI ≥ 24.0 kg/m2), advanced age, history of smoking, diabetes mellitus, and APOE ɛ3/ɛ4 genotype were independent risk factors for coronary atherosclerosis in hypertensive patients.
The impact of an exercise and sport intervention on cognitive function and pain among forcibly displaced individuals at risk for PTSD: a secondary analysis of the SALEEM randomized controlled trial
Authors: Knappe Florian , Filippou Konstantinia , Hatzigeorgiadis Antonis , Morres Ioannis D. , Ludyga Sebastian , Seelig Harald , Tzormpatzakis Emmanouil , Havas Elsa , Theodorakis Yannis , von Känel Roland , Pühse Uwe , Gerber Markus 
Published: September 2024

Abstract
Background
In response to the global scope of forced displacement, international organizations highlight the need of scalable solutions to support individuals’ health and integration into host societies. Exposure to high mental and physical stress perceived before, during, and after displacement can impair functional capabilities, essential for adapting to a new environment. This secondary analysis examined the impact of an exercise and sport intervention on cognitive function and pain severity among individuals living in a refugee camp in Greece.

Methods
We implemented a randomized controlled trial involving n = 142 (52.8% women) forcibly displaced individuals from Southwest Asia and Sub-Saharan Africa. Participants were randomly assigned to a waitlist or a 10-week co-designed exercise and sport intervention with a 1:1 allocation rate between groups and sexes. Assessments at baseline and follow-up included the Flanker task, the Oddball paradigm, pain severity via visual analog scales, and the Åstrand-Rhyming indirect test of maximal oxygen uptake. We analyzed the intervention effects using structural equation modeling.

Results
Our findings did not indicate a direct intervention effect on cognitive function or pain (p ≥ .332). However, the intervention group significantly improved cardiorespiratory fitness, ß = .17, p = .010, which was associated with faster reaction times in cognitive tasks, ß =  − .22, p = .004. Moreover, there was some evidence that adherence might be linked to reduced pain severity, ß =  − .14, p = .065.

Conclusions
Exercise and sport did not directly impact cognitive function and pain severity among a sociodemographically diverse sample living in a refugee camp, suggesting the need for complementary measures. Nevertheless, our results indicate that improvements in cardiorespiratory fitness benefit aspects of attention.

Trial registration
The study was approved by the local ethics committee of the University of Thessaly (no. 39) and registered prospectively on February 8, 2021 at the ISRCTN registry (no. 16291983).