bluuebunny/crossref_metadata_2025_split huggingface dataset:
Population pharmacokinetics and exposure‐response analyses for efficacy and safety of upadacitinib in patients with axial spondyloarthritis
Authors: Bhatnagar Sumit , Eckert Doerthe , Stodtmann Sven , Song In‐Ho , Wung Peter , Liu Wei , Mohamed Mohamed‐Eslam F. 
Published: February 2024

AbstractUpadacitinib is an orally administered, selective, Janus kinase inhibitor that is approved for several auto‐immune conditions, such as axial spondyloarthritis, an inflammatory rheumatic disease that includes ankylosing spondylitis (AS) and non‐radiographic axial spondyloarthritis (nr‐axSpA). The approvals of upadacitinib for the treatment of AS and nr‐axSpA were based on the safety and efficacy data for upadacitinib 15 mg once‐daily compared to placebo from the SELECT‐AXIS 1 and SELECT‐AXIS 2 studies. Population pharmacokinetic analyses based on data from 244 patients with axSpA showed that the pharmacokinetics of upadacitinib were comparable in subjects with AS and nr‐axSpA. Exposure‐response relationships were characterized for key efficacy and safety end points using data from 482 patients with axSpA. The exposure‐response analyses for efficacy based on Assessment of SpondyloArthritis International Society (ASAS)20 and ASAS40 responses at week 14, showed a clear differentiation from placebo with no evidence of increased responses with increasing upadacitinib plasma exposures. There were no clear exposure‐response trends observed for safety end points that included serious infections, herpes zoster, pneumonia, lymphopenia (grade ≥3), neutropenia (grade ≥3), or a greater than 2 g/dL decrease in hemoglobin from baseline through week 14. The exposure‐response analyses for efficacy and safety presented here supported the favorable benefit–risk profile with the use of upadacitinib 15 mg once‐daily for the treatment of axSpA.
The Cape Town Document on Modern Heritage (2022)
Authors:   MoHoA Participants
Published: February 2024

AbstractOne of MoHoA's main aims has been to advocate for positive and meaningful change in the reconceptualization of what might constitute modern heritage through policy and practice. Central to this endeavor is The Cape Town Document on Modern Heritage. Conceived in the spirit of the Nara Document on Authenticity (1994), which successfully achieved a similar paradigmatic shift in the global conceptualization and assessment of authenticity, The Cape Town Document seeks to achieve a similar global consensus on the reconceptualization of modern heritage. Relieved of its Eurocentric, homogenous, universalizing, developmental, and colonial associations and references that framed its definition in the 20th century, MoHoA supports its recasting as a plural and planetary phenomenon that heralded the Anthropocene. The purpose was to encourage a fuller and more complete account of global encounters with modernity through the recognition and ascription of value to cultural experiences and expressions of the modern that have until now been overlooked, marginalized, or excluded from the existing canon of modern heritage. A draft of The Cape Town Document was produced after the first MoHoA conference in 2021 and published in the MoHoA special edition of Curator: The Museum Journal in August 2022. The following draft was developed following the second MoHoA conference in October 2022 and presented to UNESCO and its advisory bodies in 2023.
Mapping hippocampal and thalamic atrophy in epilepsy: A 7‐T magnetic resonance imaging study
Authors: Lucas Alfredo , Mouchtaris Sofia , Tranquille Ashley , Sinha Nishant , Gallagher Ryan , Mojena Marissa , Stein Joel M. , Das Sandhitsu , Davis Kathryn A. 
Published: February 2024

AbstractObjectiveEpilepsy patients are often grouped together by clinical variables. Quantitative neuroimaging metrics can provide a data‐driven alternative for grouping of patients. In this work, we leverage ultra‐high‐field 7‐T structural magnetic resonance imaging (MRI) to characterize volumetric atrophy patterns across hippocampal subfields and thalamic nuclei in drug‐resistant focal epilepsy.MethodsForty‐two drug‐resistant epilepsy patients and 13 controls with 7‐T structural neuroimaging were included in this study. We measured hippocampal subfield and thalamic nuclei volumetry, and applied an unsupervised machine learning algorithm, Latent Dirichlet Allocation (LDA), to estimate atrophy patterns across the hippocampal subfields and thalamic nuclei of patients. We studied the association between predefined clinical groups and the estimated atrophy patterns. Additionally, we used hierarchical clustering on the LDA factors to group patients in a data‐driven approach.ResultsIn patients with mesial temporal sclerosis (MTS), we found a significant decrease in volume across all ipsilateral hippocampal subfields (false discovery rate‐corrected p [pFDR] < .01) as well as in some ipsilateral (pFDR < .05) and contralateral (pFDR < .01) thalamic nuclei. In left temporal lobe epilepsy (L‐TLE) we saw ipsilateral hippocampal and some bilateral thalamic atrophy (pFDR < .05), whereas in right temporal lobe epilepsy (R‐TLE) extensive bilateral hippocampal and thalamic atrophy was observed (pFDR < .05). Atrophy factors demonstrated that our MTS cohort had two atrophy phenotypes: one that affected the ipsilateral hippocampus and one that affected the ipsilateral hippocampus and bilateral anterior thalamus. Atrophy factors demonstrated posterior thalamic atrophy in R‐TLE, whereas an anterior thalamic atrophy pattern was more common in L‐TLE. Finally, hierarchical clustering of atrophy patterns recapitulated clusters with homogeneous clinical properties.SignificanceLeveraging 7‐T MRI, we demonstrate widespread hippocampal and thalamic atrophy in epilepsy. Through unsupervised machine learning, we demonstrate patterns of volumetric atrophy that vary depending on disease subtype. Incorporating these atrophy patterns into clinical practice could help better stratify patients to surgical treatments and specific device implantation strategies.
More than a mouth to clean: Case studies of oral health care in an Australian hospital
Authors: Murray Joanne , Paunovic Jasmine , Hunter Sarah C. 
Published: February 2024

ObjectiveThis study aimed to explore older patients' oral health status, their opinions about oral health care and their experiences with oral health care while in hospital.BackgroundImproving older adults' oral health is considered an urgent priority at both the national and international levels, especially for hospitalised older patients who have been found to have poor oral health. However, a one‐size‐fits‐all standardised approach to oral care delivery may not be the answer.Materials and MethodsThis study was an embedded, multiple‐case study, integrating qualitative and quantitative data. Seven patients were recruited from a geriatric ward of an acute hospital in Australia and participated in semi‐structured interviews and oral health assessments using the Oral Health Assessment Tool (OHAT) in June–July 2022. Data were analysed descriptively and presented in case summaries.ResultsOHAT assessments identified oral health problems in all patients, but not all patients self‐reported problems with their mouths. Each patient valued oral health care, but the reasons given varied. Patients had established, individualised oral health care routines, which they brought to hospital.ConclusionClinical observations of patient's oral health status might not match the patient's own judgement of their oral health and, if not explicitly addressed, may mask the need for oral health and hygiene intervention. Assessment and care planning needs to incorporate patients' own perceptions of their oral health and existing oral health care routines. Oral health histories may provide a means of facilitating this person‐centred oral health care for older patients in hospital.
Forging urban diversity regimes: A combined approach to immigrant policymaking and governance in Mannheim
Authors: Schiller Maria 
Published: February 2024

AbstractAs migration continues to shape urban societies, how cities deal with migration‐based heterogeneity has become a salient issue. Much literature addressing immigrant policymaking has focused on current policy ideas and the different actors they involve; literature on urban governance has highlighted the role of collaboration between state and civil society actors. To date, however, limited research has taken a combined approach to see how municipalities forge collaboration with civil society in pursuit of (novel) policy ideas. The article draws on and combines immigrant policymaking, urban governance and urban regime literatures. It presents Mannheim as a heuristic case which shows how the city's immigrant policymaking reflects a combination of a shift towards 'diversity' as policy idea and discourse and long‐term collaboration in policymaking. Positing the emergence of an “urban diversity regime” in Mannheim, the article reflects on the opportunities this heuristic notion presents for existing literature and for future research.
Unearthing the genotype‐inhibitor phenotype association in severe haemophilia A: A north Indian cohort study
Authors: Ray Debadrita , Sharma Ritika , Kumar Narender , Hans Chander , Senee Harikishan , Jamwal Manu , Ahluwalia Jasmina , Das Reena , Bansal Deepak , Jain Arihant 
Published: February 2024

AbstractIntroductionVarious risk factors for inhibitor development in haemophilia A (HA) have been described but Indian data remains scanty.AimWe aimed to evaluate the genetic changes in Indian HA‐patients that are associated with the development of inhibitors.MethodsAll HA‐patients with inhibitors who availed coagulation‐laboratory services from January‐2015 till December‐2021 and had their samples preserved for DNA extraction were included in this study. An equal number of severity‐matched HA patients without inhibitors were also included as controls. Intron 22 and intron 1 inversions in Factor VIII gene were identified using inverse‐shifting‐PCR. Inversion‐negative patients were further assessed by targeted NGS, MLPA.ResultsThirty HA‐patients with inhibitors were identified. All had severe‐HA. Thirty severe‐HA‐patients without inhibitors were also included as controls. Intron 22 inversion (63.3%) and large deletions (15%) were the commonest variants identified. There was no difference in genetic variants in patients with low and high titre inhibitors. A3, A2 and C2 were the most common domains involved in inversion‐negative patients with inhibitors. However, there was no significant difference in domain involvement among inversion‐negative patients with and without inhibitors. Seven novel‐variants were identified, including three large deletions, one large duplication and two nonsense variants in inhibitor‐positive patients, and one frameshift variant in inhibitor‐negative patient. After adjusting for clinical risk‐factors, large deletions were independently associated with the presence of inhibitors [aOR:6.1 (1.41‐56.3)].ConclusionIntron 22 inversions are the commonest variant in Indian patients with severe‐HA. Large deletions predispose to inhibitor development independent of clinical risk factors.
Bone mineral density in haemophilia patients: A systematic review and meta‐analysis
Authors: Zhang Meiling , Song Ke , Wu Weifei 
Published: February 2024

AbstractIntroductionWith the increase in life expectancy of haemophilia patients (PWH), the risk of osteoporosis increases, but there is little research on whether haemophilia is the cause of osteoporosis.AimTo conduct systematically review whether bone mineral density (BMD) in PWH decreased and the factors affecting BMD.MethodsTwo authors independently searched databases and reviewed citations from relevant articles, selecting studies published in any language and performed in humans before March 2023. Eligibility criteria were observational studies in PWH, with BMD as at least one outcome other than osteoporosis or bone loss, and analyses in a group of PWH and healthy controls.ResultsTwelve studies were ultimately identified, consisting of 1210 individuals (534 PWH and 676 healthy controls), compared with the control group, BMD in PWH decreased by 0.13 g/cm2 [95% confidence interval (CI) ‐0.18 to ‐0.08, I2 = 89%]. No evidence of publication bias was detected. There was no evidence that age, BMI, level of physical activity, the types of haemophilia, haemophilia severity, a blood‐borne virus (HCV) and treatment modality predicted the BMD in PWH.ConclusionThe results indicate that BMD in PWH is lower than in healthy controls. Therefore, we strongly recommend PWH early measurement of BMD to prevent osteoporosis.
Targeting a higher plasma VWF level at time of delivery in pregnant individuals with von Willebrand disease: Outcomes at a single‐institution cohort study
Authors: Lim Ming Y. , Rodgers George M. , Branch D. Ware , Simonsen Sara E. 
Published: February 2024

AbstractIntroductionGuidelines on the management of pregnant individuals with von Willebrand disease (VWD) at the time of delivery recommend that von Willebrand factor (VWF) and factor VIII:C (FVIII:C) levels be ≥50% to prevent postpartum haemorrhage (PPH). Yet, high PPH rates persist despite these levels or with prophylactic factor replacement therapy to achieve these levels.AimsThe current practice at our centre has been to target peak plasma VWF and FVIII:C levels of ≥100 IU/dL at time of delivery. The objective of this study was to describe obstetric outcomes in pregnant individuals with VWD who were managed at our centre.MethodsDemographics and outcomes on pregnant individuals with VWD who delivered between January 2015 and April 2023 were collected.ResultsForty‐seven singleton deliveries (among 41 individuals) resulting in 46 live births and one foetal death were included. Twenty‐one individuals had at least one prior birth by the start date of this study, of which 11 (52.4%) self‐reported a history of PPH. Early PPH occurred in 12.8% (6/47) of deliveries. Two individuals required blood transfusion, of which one also had an unplanned hysterectomy and transfer to ICU. There were no thrombotic events reported.ConclusionThe strategy of targeting higher peak plasma VWF and FVIII:C levels (≥100 IU/dL) at the time of delivery may be effective in reducing the risk of delivery‐associated bleeding complications in VWD patients. Yet, the rate of early PPH remains unsatisfactory compared to the non‐VWD population.
Measurement of recombinant porcine factor VIII in patients with congenital haemophilia A and inhibitors in the presence of emicizumab
Authors: Pfrepper Christian , Klamroth Robert , Ettingshausen Carmen Escuriola , Petros Sirak , Siegemund Annelie , Siegemund Thomas 
Published: February 2024

AbstractIntroductionRecombinant porcine factor VIII (rpFVIII) is a treatment option for break‐through bleeds in patients with congenital haemophilia A with inhibitors (CHAwI) on emicizumab. However, there are limited data about the measurement of rpFVIII in the presence of emicizumab.AimTo analyse whether rpFVIII can be measured with a chromogenic assay with bovine component (bCSA) in plasma from CHAwI on emicizumab treatment.MethodsIn the first part of the study, FVIII deficient plasma was spiked with rpFVIII, in the second part, commercial plasma from CHAwI was spiked with emicizumab and rpFVIII, and in the third part, plasma from CHAwI on emicizumab treatment was spiked with rpFVIII. FVIII was then measured with bCSA and a chromogenic assay with human component (hCSA). Thrombin generation (TG) and clot‐waveform analysis (CWA) were also carried out.ResultsThe recovery of rpFVIII measured with bCSA is approximately 80% and is further influenced by the presence of an anti‐porcine inhibitor. rpFVIII assessed with hCSA was influenced by emicizumab. CWA and TG showed a weak correlation with baseline emicizumab concentration, but peak thrombin and CWA correlated well with increasing emicizumab concentrations and rpFVIII activities.ConclusionThis study indicates that rpFVIII can be measured in the presence of emicizumab with a bCSA. A calibration curve for the measurement of rpFVIII with bCSA should be established.
A qualitative evaluation of a co‐design process involving young people at risk of suicide
Authors: Kehoe Michelle , Whitehead Rick , de Boer Kathleen , Meyer Denny , Hopkins Liza , Nedeljkovic Maja 
Published: February 2024

AbstractBackgroundCo‐design is becoming common practice in the development of mental health services, however, little is known about the experience of such practices, particularly when young people are involved.ObjectiveThe aim of this study was to conduct a process evaluation of the co‐design which was undertaken for the development of an intervention for youth and adolescents at risk of suicide. This paper briefly outlines the co‐design process undertaken during a COVID‐19 lockdown and then focuses on a qualitative evaluation of the experience of taking part in a co‐design process.Setting and ParticipantsThe evaluation involved young consumers of a public youth mental health service, their carers/parents and service delivery staff who had taken part in the co‐design process.MethodThis study used follow‐up semistructured interviews with the co‐design participants to explore their experience of the co‐design process. Inductive thematic analysis was used to draw out common themes from the qualitative data.ResultsIt was found that despite the practical efforts of the project team to minimise known issues in co‐design, challenges centred around perceptions regarding power imbalance, the need for extensive consultation and time constraints still arose.DiscussionDespite these challenges, the study found that the co‐design provided a human‐centred, accessible and rewarding process for young people, parents and staff members, leaving them with the feeling that they had made a worthwhile contribution to the design of the new service, as well as contributing to changing practice in service design.ConclusionWith sensitivity and adaptation to usual practice, it is possible to include young people with suicidal ideation, their parents/carers and professional staff in a safe and effective co‐design process.Patient and Public ContributionThe authors would like to thank and acknowledge the young people with a lived experience and their carers who participated in the co‐design process and research evaluation component of this study. We also wish to thank the clinical staff, peer workers and family peer workers who participated in this research.
Mobile applications (apps) as service provider actors
Authors: Orsingher Chiara , McColl‐Kennedy Janet R. , Zaki Mohamed , Green Teegan , Varnfield Marlien , Li Jane , Butten Kaley , Titman Jason , Hansen David 
Published: February 2024

AbstractContextualized in health care service, the authors contribute to service experience theory and practice in three important ways. First, by means of qualitative interviews with patients and health care providers (clinicians and professionals), the authors empirically show that digital technology (mobile application—“app” with its companion portal) can perform the roles of a service provider in health care experiences, identifying six key roles. Second, the authors illustrate how apps, as service providers, can potentially transform the health care experience, influencing the roles and forms of interactions with other actors in the service ecosystem. Third, a typology of roles and key functions highlighting interactions and impact of the app and portal on the health care experience is developed. Drawing on institutional logics and role theory, this article aims to provide new insights into service provider roles that are not confined solely to humans. Our goal is to show that apps can undertake a range of roles to enrich interactions and potentially enhance the health care experience. First, the authors provide evidence that an app can perform the roles of connector, coordinator, counselor, enabler, instructor, and watchperson, impacting on the roles of others in the service ecosystem and the health care experience. Then, guidelines to assist organizations in designing a service using an app as a service provider are offered, together with an agenda to guide future research.
Role of research Laboratories in pandemic and epidemic response in the Eastern Mediterranean Region: Experiences from COVID‐19, avian influenza, and MERS‐CoV
Authors: Mahmoud Mona , Badra Rebecca , Kandeil Ahmed , El‐Shesheny Rabeh , Abdallah Jad , Ali Mohamed A. , Kayali Ghazi 
Published: February 2024

AbstractWe share the experience of research laboratories in the Eastern Mediterranean Region (EMR) that contributed to preparedness and response to highly pathogenic avian influenza (HPAI), Middle‐East respiratory syndrome coronavirus (MERS‐CoV), and coronavirus disease (COVID‐19). Research groups in the region were pivotal in identifying, characterizing the pathogens and describing their evolution, distribution, transmission routes, and the immunological profile of exposed populations. They demonstrated the capacity to develop and test antivirals and potential vaccines. The EMR experience is a model of how national systems can work with researchers to improve regional preparedness and response to future epidemics and pandemics.
Competing platform owners’ entry and an OEM's cooperation response
Authors: Wu Xiangxiang , Zha Yong , Liang Liang 
Published: February 2024

AbstractThis paper develops a game‐theoretic model that examines the entry decisions of two competing platform owners with differentiated research and development (R&D) efficiency and the response strategy of an original equipment manufacturer (OEM) in selecting which platform to cooperate with. The OEM and platform owners compete on quality and price in the face of consumers with heterogeneous preferences across the dimensions of the device and platform. We analyze the interaction between the entry decisions of platform owners and the OEM's response strategy within two cooperation models. In the charging model, we find that in the absence of entry, the OEM prefers the high‐efficiency platform. When only one platform owner enters, the OEM prefers the low‐efficiency platform. If the differentiated R&D efficiency and the device differentiation cost are large, both platform owners will choose to enter and the OEM will cooperate with the low‐efficiency platform. In the bundling model, when only one platform owner enters, only at a large cost of device differentiation will the OEM cooperate with the platform that enters the market to weaken market competition. In particular, when only the high‐efficiency platform enters, it is interesting that there exists a large cost of device differentiation that makes the high‐efficiency platform more favorable in the case when the OEM cooperates with the low‐efficiency platform. Our study provides practical insights into platform entry and OEM response.