bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase 2, multicenter, open-label basket trial of nab-sirolimus for patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes (PRECISION I).
Authors: Iyer Gopa , Demeure Michael J. , Deming Dustin A. , Federman Noah , McKean Meredith , Lee Elizabeth Katherine , Spira Alexander I. , Kwiatkowski David J. , Hussein Maen A. , Gordon Erlinda Maria , Crockett David G. , Ganjoo Kristen N. , Schulte Brian , Cranmer Lee D. , Schmid Anita N. , Navarro Willis H. , Itri Loretta Marie 
Published: March 2023

TPS597 Background: Albumin-bound ( nab)-sirolimus, a novel mTOR inhibitor (mTORi) that utilizes nanoparticle technology to preferentially target tumors, is approved in the US for the treatment of adults with malignant PEComa. In an exploratory analysis of the AMPECT registrational trial of nab-sirolimus in advanced malignant PEComa (NCT02494570), 8/9 (89%) and 1/5 (20%) patients with TSC1 and TSC2 inactivating alterations, respectively, had confirmed response (Wagner, J Clin Oncol. 2021). Importantly, both TSC1 and TSC2 alterations have been observed in patients with various gastrointestinal cancers (Table). Overall, most treatment-related adverse events (TRAEs) in AMPECT were grade 1/2 and manageable for long-term treatment; no grade ≥4 TRAEs occurred. Methods: PRECISION I (NCT05103358) is a phase 2, open-label, multi-institutional basket trial evaluating efficacy and safety of nab-sirolimus in patients with alterations in TSC1 (Arm A) and TSC2 (Arm B). Patients ≥12 years old with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 (confirmed by central review of next-generation sequencing reports) who have progressed on standard therapies and are mTORi-naïve are eligible. nab-Sirolimus 100 mg/m2 will be administered weekly as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle. The primary endpoint is overall response rate determined by independent review using RECIST v1.1; other endpoints include duration of response, disease control rate, time to response progression-free survival by independent radiographic review, overall survival, patient-reported quality of life, and safety. Enrollment is ongoing. The most frequent tumor types expected in this tissue-agnostic trial are bladder, hepatobiliary, endometrial, soft tissue sarcoma, ovarian, and esophagogastric based on the prevalence of TSC1 or TSC2 alterations (Table). Clinical trial information: NCT05103358 . [Table: see text]
Spin and angular momentum in quaternionic quantum mechanics
Authors: Giardino Sergio 
Published: March 2023

Abstract
We present two novel solutions of real Hilbert state quaternionic quantum mechanics

. Firstly, we observe that the angular momentum operator admits two different classes of physically non-equivalent free particles. As a second result, we study the Larmor precession to observe that it has a quaternionic solution where a novel phenomenological interpretation is possible, as well as a different spin is possible, and these results may encourage experimental and theoretical investigations of the quaternionic theory.
Identification of protective and ‘at risk’ HLA genotypes for the development of pseudotumours around metal-on-metal hip resurfacings
Authors: Sheridan Gerard A. , Hanlon Michael , Welch-Phillips Adanna , Spratt Karen , Hagan Richard , O'Byrne John M. , Kenny Patrick J. , Kurmis Andrew P. , Masri Bassam A. , Garbuz Donald S. , Hurson Conor J. 
Published: March 2023

AimsHip resurfacing remains a potentially valuable surgical procedure for appropriately-selected patients with optimised implant choices. However, concern regarding high early failure rates continues to undermine confidence in use. A large contributor to failure is adverse local tissue reactions around metal-on-metal (MoM) bearing surfaces. Such phenomena have been well-explored around MoM total hip arthroplasties, but comparable data in equivalent hip resurfacing procedures is lacking. In order to define genetic predisposition, we performed a case-control study investigating the role of human leucocyte antigen (HLA) genotype in the development of pseudotumours around MoM hip resurfacings.MethodsA matched case-control study was performed using the prospectively-collected database at the host institution. In all, 16 MoM hip resurfacing 'cases' were identified as having symptomatic periprosthetic pseudotumours on preoperative metal artefact reduction sequence (MARS) MRI, and were subsequently histologically confirmed as high-grade aseptic lymphocyte-dominated vasculitis-associated lesions (ALVALs) at revision surgery. ‘Controls’ were matched by implant type in the absence of evidence of pseudotumour. Blood samples from all cases and controls were collected prospectively for high resolution genetic a nalysis targeting 11 separate HLA loci. Statistical significance was set at 0.10 a priori to determine the association between HLA genotype and pseudotumour formation, given the small sample size.ResultsUsing a previously-reported ALVAL classification, the majority of pseudotumour-positive caseswere found to have intermediate-grade group 2 (n = 10; 63%) or group 3 (n = 4; 25%) histological findings. Two further patients (13%) had high-grade group 4 lesions. HLA-DQB1*05:03:01 (p = 0.0676) and HLA-DRB1*14:54:01 (p = 0.0676) alleles were significantly associated with a higher risk of pseudotumour formation, while HLA-DQA1*03:01:01 (p = 0.0240), HLA-DRB1*04:04:01 (p = 0.0453), HLA-C*01:02:01 (p = 0.0453), and HLA-B*27:05:02 (p = 0.0855) were noted to confer risk reduction.ConclusionThese findings confirm the association between specific HLA genotypes and the risk of pseudotumour development around MoM hip resurfacings. Specifically, the two ‘at risk’ alleles (DQB1*05:03:01 and DRB1*14:54:01) may hold clinical value in preoperative screening and prospective surgical decision-making.Cite this article: Bone Jt Open 2023;4(3):182–187.
Impact of adverse events during community-wide mass drug administration for soil-transmitted helminths on subsequent participation–a Theory of Planned Behaviour analysis
Authors: Aruldas Kumudha , Israel Gideon John , Johnson Jabaselvi , Titus Angelin , Saxena Malvika , Kaliappan Saravanakumar Puthupalayam , Ramesh Rohan Michael , Walson Judd L. , Means Arianna Rubin , Ajjampur Sitara S. R. 
Published: March 2023

Background
Experiencing adverse events (AEs) during mass drug administration (MDA) could affect participation in future MDAs. This study aims to understand the potential influence of AEs during a community-wide MDA (cMDA) trial for soil-transmitted helminths (STH) in India on intention to participate in future cMDAs.

Methods
This study was conducted using a multi-method quantitative and qualitative approach among 74 participants who experienced an AE during STH cMDA and the 12 participants who subsequently refused cMDA treatment of the ongoing DeWorm3 trial. Path analysis and thematic analysis guided by the Theory of Planned Behaviour, was used.

Principal findings
Among 74 individuals who reported an AE, 12% refused treatment in the cMDA immediately subsequent to their AE and 4% refused in all subsequent cMDAs. Of these 74 individuals, 59 (80%) completed a survey and eight participated in in-depth interviews. A positive attitude towards deworming and perceived ability to participate in cMDA (perceived behavioural control) were significant predictors of intention to participate in cMDA (p<0.05). A positive attitude towards cMDA was associated with caste (χ2 = 3.83, P = 0.05), particularly among the scheduled caste/scheduled tribe (SC/ST) (62%). Perceived behavioural control in cMDA participation was associated with occupation (χ2 = 5.02, P<0.05), with higher perceived control among those engaged in skilled occupations (78%). Intention to participate in subsequent cMDAs was associated with caste and family type (χ2 = 3.83, P = 0.05 and χ2 = 7.50, P<0.05 respectively) and was higher among SC/ST (62%) and those with extended families (67%). In-depth interviews demonstrated that perceived severe AEs may lead to treatment refusal in future, particularly if children were affected.

Conclusions
Intention to participate in future STH cMDAs was associated with caste (SC/ST) and family type (extended families). Therefore, community mobilization messages about potential AEs and their management may need to intentionally target non-SC/ST households, nuclear families, and those engaged in unskilled occupations to increase cMDA participation given the possibility of AEs occurring.

Trial registration
NCT03014167, ClinicalTrials.gov.
Design and implementation of a global site assessment survey among HIV clinics participating in the International epidemiology Databases to Evaluate AIDS (IeDEA) research consortium
Authors: Brazier Ellen , Maruri Fernanda , Wester C. William , Musick Beverly , Freeman Aimee , Parcesepe Angela , Hossmann Stefanie , Christ Benedikt , Kimmel April , Humphrey John , Freeman Esther , Enane Leslie A. , Lancaster Kathryn E. , Ballif Marie , Golub Jonathan E. , Nash Denis , Duda Stephany N. ,   on behalf of the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium
Published: March 2023

Introduction
Timely descriptions of HIV service characteristics and their evolution over time across diverse settings are important for monitoring the scale-up of evidence-based program strategies, understanding the implementation landscape, and examining service delivery factors that influence HIV care outcomes.

Methods
The International epidemiology Databases to Evaluate AIDS (IeDEA) consortium undertakes periodic cross-sectional surveys on service availability and care at participating HIV treatment sites to characterize trends and inform the scientific agenda for HIV care and implementation science communities. IeDEA’s 2020 general site assessment survey was developed through a consultative, 18-month process that engaged diverse researchers in identifying content from previous surveys that should be retained for longitudinal analyses and in developing expanded and new content to address gaps in the literature. An iterative review process was undertaken to standardize the format of new survey questions and align them with best practices in survey design and measurement and lessons learned through prior IeDEA site assessment surveys.

Results
The survey questionnaire developed through this process included eight content domains covered in prior surveys (patient population, staffing and community linkages, HIV testing and diagnosis, new patient care, treatment monitoring and retention, routine HIV care and screening, pharmacy, record-keeping and patient tracing), along with expanded content related to antiretroviral therapy (differentiated service delivery and roll-out of dolutegravir-based regimens); mental health and substance use disorders; care for pregnant/postpartum women and HIV-exposed infants; tuberculosis preventive therapy; and pediatric/adolescent tuberculosis care; and new content related to Kaposi’s sarcoma diagnostics, the impact of COVID-19 on service delivery, and structural barriers to HIV care. The survey was distributed to 238 HIV treatment sites in late 2020, with a 95% response rate.

Conclusion
IeDEA’s approach for site survey development has broad relevance for HIV research networks and other priority health conditions.
Prevalence and associated factors of insomnia symptoms during the COVID-19 pandemic lockdown among Mettu town residents
Authors: Lelisho Mesfin Esayas , Wotale Teramaj Wongel , Tareke Seid Ali 
Published: March 2023

BackgroundInsomnia is a prevalent sleep disorder that affects people all over the world. Creating suitable interventions will require a better understanding of the magnitude and determinants of insomnia. This study aimed to assess the prevalence and associated factors of insomnia symptoms among residents of Mettu town during the pandemic lockdown.MethodologyA community-based cross-sectional study was conducted among residents of Mettu town from October 1stto October 15th, 2020. Residents who lived in Mettu town at least for six months were included. To determine the prevalence and determinants of insomnia symptoms, both descriptive and inferential analyses were used. The chi-squared test of association and logistic regression was used to identify predictors of insomnia symptoms among residents of Mettu town. We used SPSS version 25 for all statistical analyses.Principal findingsThe prevalence of depressive symptoms among residents of Mettu town was 52.6%. According to results of multivariable binary logistic regression, being female [AOR = 3.677, 95%CI: 2.124–6.365], being aged between 19 and 40 [AOR = 13.261, 95%CI: 6.953–25.291], being aged above 41 [AOR = 2.627, 95%CI: 1.120–6.159], smoking [AOR = 15.539, 95%CI: 7.961–30.329], satisfaction with information available [AOR = 0.310, 95%CI: 0.168–0.570], fear Corona Virus Disease 2019 (COVID-19), [AOR = 2.171, 95%CI: 1.262–3.733], feeling alienated from others [AOR = 3.288, 95%CI: 1.897–5.699], having somatic symptoms [AOR = 2.298, 95% CI: 1.360–3.884], having depressive symptoms [AOR = 1.841, 95% CI: 1.073–3.160], and experiencing psychological distress [AOR = 1.962, 95% CI: 1.173–3.281] were significantly associated with insomnia symptoms.ConclusionIn this study, the prevalence of insomnia symptoms was found to be high among residents of Mettu town. Being female, being aged between 19 and 40, being aged above 41 years, smoking, fear of Corona Virus Disease 2019, feeling alienated from others, having somatic symptoms, having depressive symptoms, and experiencing psychological distress were all associated with an increased risk of developing insomnia symptoms while being satisfied with the information available decreased the risk of insomnia symptoms among residents of Mettu town. Interventions should be put in place to promote healthy sleep among residents of Mettu town.
Establishing evidence to inform culturally competent mental health services: A mixed methods study protocol
Authors: Yu Ge , Panagioti Maria , Tang Eugene Y. H. , Robinson Damian , Husain Nusrat , Lasrado Reena , Lovell Karina , Kaner Eileen , Fu Yu 
Published: March 2023

Background
COVID-19 has exacerbated the significant and longstanding mental health inequalities for ethnic minorities, who were less likely to access mental health support in primary care but more likely to end up in crisis care compared to the majority ethnic group. Services were poorly offered and accessed to respond to the increased mental health challenges.

Aim
To 1) establish evidence on which changes to mental health services provided in response to COVID-19 are beneficial for ethnic minorities who experience mental health difficulties in the North of England, and 2) to inform what and how culturally competent mental health services should be routinely provided.

Methods
A mixed methods approach comprising 1) a rapid review to map services and models of care designed or adjusted for mental health during the pandemic, 2) an observational study of retrospective routine data to assess changes to mental health services and associated outcomes, 3) qualitative interviews to understand experiences of seeking care and factors associated with high-quality service provision, and 4) a Delphi study to establish consensus on key features of culturally competent services. From the selected areas in the North of England, adults from ethnic minorities who experience mental health difficulties will be identified from the primary, community and secondary care services and local ethnic minority communities.

Discussion
This study will identify ways to tackle health inequalities and contribute to mental health service recovery post pandemic by providing practice recommendations on equitable and effective services to ensure culturally competent and high-quality care. A list of services and features on what and how mental health services will be provided. Working with study collaborators and public and patient involvement partners, the study findings will be widely disseminated through presentations, conferences and publications and will inform the subsequent funding application for intervention development and evaluation.
Challenges of Transhumanism for Virtue Ethics
Authors: Vivoda Michal 
Published: March 2023

Abstract
In this paper we consider some of the basic elements of virtue ethics in confrontation with selected ideas of representatives of trans- and post-humanism. Their ideas challenge us to re-justify and defend the uniqueness of man (the person) as a moral subject in his complex relational physical-psycho-spiritual unity. Using this holistic moral-anthropological vision, it is possible to justify the uniqueness of the human act as moral; the nature and significance of virtue as a moral disposition for a truly good and happy life; the nature and significance of happiness as a true complex eudaimonia in the dynamics of human development. In this complex process, technical artefacts and technologies help man to act in a truly human way towards himself and others, if he uses them rightly.
G. Deleuze’s Untimely [non-]: The Inverter of Platonic Nihilism to Ethics of Creation
Authors: Nevrokoplis Konstantinos 
Published: March 2023

Abstract
In F. Nietzsche’s philosophical thought, there is a profound link between European Nihilism and the task of modern philosophy to produce new Platos. The current article demonstrates how G. Deleuze uses the Nietzschean term Unzeitgemäβ – (Untimely – Unfashionable) in his attempt to overturn nihilistic Platonism. Deleuze enriches the Stoic paradox of [non-] when seeking an image of thought without image for the sake of what he calls the “untimely creative intensity,” an affirmative power in immanence. I argue that Deleuze reads the Stoic [non-] using the lens of the Nietzschean untimely to construct the technique of reversibility in his philosophical plane. Following the cartography of Deleuze’s philosophical route, I first examine two problems caused by Platonic nihilism: the destruction of the form in anonymity and the noiseless transmutation of copies into simulacra. Second, I discuss Deleuze’s two types of nihilism: (i) the cruciform structure of the Platonic and (ii) the use of the paradox of the [non-] upon the surface by Stoics. Finally, I comment on Deleuzian nihilism as the birthplace of creation.
Barley thermoplastic starch nanocomposite films reinforced with nanocellulose
Authors: Sharip Nur Sharmila , Tengku Yasim-Anuar Tengku Arisyah , Husin Hazwani , Norrrahim Mohd Nor Faiz 
Published: March 2023

Abstract
Despite being one of the starch producers, barley has yet to be widely studied for thermoplastic starch applications, including nanocellulose thermoplastic composites, due to its uses in the food and beverage industries. However, only 20% of barley is used in the malting industry to produce both alcoholic and non-alcoholic beverages, and 5% is used as an ingredient in a wide variety of foods. As the fourth most important cereal in the world after wheat, corn, and rice, barley can be considered an interesting biomass source to produce biodegradable thermoplastics, stemming from its starch constitution. Therefore, this review attempts to highlight the barley starch properties and its potential utilization for nanocellulose thermoplastic starch composites. Several studies involving barley-based starch in thermoplastic production and nanocellulose reinforcement for properties enhancement are also reviewed, particularly in the attempt to provide various options to reduce and replace the uses of harmful petroleum-based plastic.
ETHICAL AND ECOLOGICAL PERSONAL UP-BRINGING BY MEANS OF LITERARY WORDS THROUGH THE AUTHOR’S CONCEPT OF VASYL SUKHOMLYNSKYI
Authors: Bilavych Halyna , Ozarko Veronika , Khanas Oleksandra , Litvin Yulia 
Published: March 2023

The aim of the study is to analyze the author's system of ethical and ecological education of the personality of Vasyl Sukhomlynskyi, to characterize the creative heritage of the scientist, to single out literary works for children with a moral and ecological content. Leading in the pedagogical legacy, in particular the literary work, of the outstanding Ukrainian scientist V. Sukhomlynskyi is the problem of moral education, which was the author's pedagogical system and found a practical embodiment in the Pavlysh secondary school, which the innovative teacher headed for almost thirty years. The conceptual provisions of the author's system of moral education of V. Sukhomlynskyi about the unity of moral education and nature conservation are important, especially nowadays, when the preservation of the Carpathian Mountains is gaining national importance, and the problems of ecological education of the individual are becoming an important condition for sustainable development in its global dimension. This problem sounds in a new way under the conditions of Russia's invasion of the territory of Ukraine on February 24, 2022, which caused the destruction of ecosystems, natural resources, chemical pollution of territories, waters, etc. Therefore, the problem of ecological education of children and youth is becoming actualized, they should become active ecologists-saviors of native nature and the environment, accordingly, teachers should develop a set of environmental measures of nature conservation content, develop a new philosophy of the formation of ecological culture of the individual throughout life, give ecological education of the individual a new sound, in particular practice oriented direction. It is proven that in this process it is possible to use the creative achievements of V. Sukhomlynskyi, whose literary works for children are an effective means of forming ethical and ecological education of children and adults. Each fairy tale or story with an environmental content offers the reader an invaluable moral lesson. These works are a moral code, a table book that you need to read every day in order to build your relationship with nature properly, to protect it, to take care of all living things, they are a kind of pedagogical commandments on how to be a person and, under today's conditions, to grow into an effective environmentalist in order to preserve not only nature, but also Ukraine.
Keywords: V. Sukhomlynskyi, author's system, teacher-innovator, ethical and ecological education, literary works for children, ecological education, New Ukrainian school.