bluuebunny/crossref_metadata_2025_split huggingface dataset:
Integrating qualitative interviews in drug development and the use of qualitative evidence in product labelling and health technology assessments: a review
Authors: Michel Anne-Sophie , Kamudoni Paul , Marrel Alexia , Adiutori Rocco , Desvignes-Gleizes Céline , Lanar Sally , Schache Peter , Spies Erica , Park Josephine 
Published: June 2023

ObjectiveIncluding qualitative research in clinical trial design is an innovative approach to understanding patients’ perspective and incorporate the patient’s voice in all stages of drug development and evaluation. This review aims to explore current practices, lessons learned from the literature, as well as how qualitative interviews are considered by health authorities for marketing authorization and reimbursement.MethodsA targeted literature review of Medline and Embase databases was conducted in February 2022 to identify publications on qualitative methods embedded in clinical trial of pharmaceutical products. An additional search of guidelines and labeling claims of approved products regarding qualitative research was performed in various sources of grey literature.ResultsFrom the 24 publications and nine documents reviewed, we identified the research questions addressed with qualitative methods during clinical trials (e.g., change in quality of life, symptoms assessment, treatment benefit), preferred data collection methods (e.g., interviews), and data collection points (e.g., baseline and exit interviews). Moreover, the data from labels and HTAs demonstrate that qualitative data can play an important role in approval processes.ConclusionThe use of in-trial interviews is still emerging and is not yet common practice. Although the industry, scientific community, regulatory agencies and HTAs are showing an increasing interest in the use of evidence generated via in-trial interviews, guidance from regulators and HTAs would be helpful. Developing new methods and technologies to address the common challenges for such interviews is key to progress.
Rhubarb polysaccharide and berberine co-assembled nanoparticles ameliorate ulcerative colitis by regulating the intestinal flora
Authors: Feng Yifan , Wu Chenyang , Chen Huan , Zheng Tingting , Ye Hanyi , Wang Jinrui , Zhang Yinghua , Gao Jia , Li Ying , Dong Zhengqi 
Published: June 2023

Introduction: Inflammatory bowel disease (IBD) affects about 7 million people globally, which is a chronic inflammatory condition of the gastrointestinal tract caused by gut microbiota alterations, immune dysregulation, genetic and environmental factors. Nanoparticles (NPs) deliver an active natural compound to a site harbored by disordered microbiota, they are used to interact, target and act intentionally on microbiota. Although there is accumulating evidence indicating that berberine and polysaccharide play an important role in IBD via regulating microbiota, there is limited research that presents a complete picture of exactly how their carrier-free co-assembled nanodrug affects IBD.Methods: The study establishes the carrier-free NPs formed by berberine and rhubarb polysaccharide based on the combination theory of Rheum palmatum L. and Coptis chinensis Franch., and characterizes the NPs. The IBD treatment efficacy of NPs are evaluated via IBD efficacy index, and explore the mechanism of NPs via 16S rRNA test and immunohistochemistry including occludin and zonula occludens-1.Results: The results showed that DHP and BBR were co-assembled to nanoparticles, and the BD can effectively relieve the symptoms of UC mouse induced by DSS via regulating gut microbiota and repair the gut barrier integrity, because BD have a longer retention on the colon tissue and react with the microbiota and mucus thoroughly. Interestingly, BD can enrich more probiotic than free BBR and DHP.Discussion: This design provides a better strategy and encourages future studies on IBD treatment via regulating gut microbiota and the design of novel plant polysaccharide based carrier-free co-assembly therapies.
The assessment of qualitative olfactory dysfunction in COVID-19 patients: a systematic review of tools and their content validity
Authors: Espetvedt Annelin , Wiig Siri , Myrnes-Hansen Kai Victor , Brønnick Kolbjørn Kallesten 
Published: June 2023

BackgroundThere is a lack of overview of the tools used to assess qualitative olfactory dysfunction, including parosmia and phantosmia, following COVID-19 illness. This could have an impact on the diagnosis and treatment offered to patients. Additionally, the formulations of symptoms are inconsistent and often unclear, and consensus around the wording of questions and responses is needed.Aim of studyThe aim of this systematic review is to provide an overview of tools used to assess qualitative olfactory dysfunction after COVID-19, in addition to addressing the content validity (i.e., item and response formulations) of these tools.MethodsMEDLINE, Web of Science, and EMBASE were searched 5th of August 2022 and updated on the 25th of April 2023 to identify studies that assess qualitative olfactory dysfunction in COVID-19 patients. Primary outcomes were the tool used (i.e., questionnaire or objective test) and item and response formulations. Secondary outcomes included psychometric properties, study design, and demographic variables.ResultsThe assessment of qualitative olfactory dysfunction is characterized by heterogeneity, inconsistency, and lack of validated tools to determine the presence and degree of symptoms. Several tools with overlapping and distinct features were identified in this review, of which some were thorough and detailed, while others were merely assessing the presence of symptoms as a binary measure. Item and response formulations are also inconsistent and often used interchangeably, which may lead to confusion, incorrect diagnoses, and inappropriate methods for solving the problem.ConclusionsThere is an unmet need for a reliable and validated tool for assessing qualitative olfactory dysfunction, preferably one that also captures quantitative olfactory issues (i.e., loss of smell), to ensure time-effective and specific assessment of the ability to smell. A consensus around the formulation of items and response options is also important to increase the understanding of the problem, both for clinicians, researchers, and the patient, and ultimately to provide the appropriate diagnosis and treatment.Registration and protocolThe URL is https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=351621. A preregistered protocol was submitted and accepted (12.09.22) in the International prospective register of systematic reviews (PROSPERO) with the registration number CRD42022351621.
The latent factor structure and assessment of childbirth-related PTSD: psychometric characteristics of the City Birth Trauma Scale—Persian version (City-BiTS-P)
Authors: Vatanparast Amin , Kamrani Ali , Shakiba Shima , Amouchie Ramin , Akbari Elnaz , Ayers Susan 
Published: June 2023

ObjectiveThere is no validated Persian questionnaire to measure childbirth-related PTSD (CB-PTSD) symptoms. To cover this gap, the present study aimed to provide a Persian version of the City Birth Trauma Scale (CityBiTS-Pr) and to determine its psychometric properties.MethodSince this is a cross-sectional study, sampling was done using a convenient sampling method. In total, 300 Persian-speaking women took part in this study and completed the City Birth Trauma Scale (CityBiTS-Pr), the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), the Edinburgh Postnatal Depression Scale (EPDS), the Anxiety Subscale of the Depression, and the Anxiety and Stress Scale (DASS-21). In addition, sociodemographic information was completed. A confirmatory factor analysis of two- and four-factor models and a bi-factor model with a general factor and two specific factors were tested. Fit indices were calculated for all three models. Reliability, convergent, divergent, and discriminant validity also were examined. R v4.2.1 and SPSS v23 were used for data analysis.ResultsThe four-factor model comprised intrusion, avoidance, negative cognitions and mood, and hyper-arousal showed a poor fit. The two-factor model composed of “birth-related symptoms” and “general symptoms” provided the best results based on all fit indices. The bi-factor result was relatively good, but the loadings indicated that the general symptoms factor is not well defined.ConclusionThe Persian version of the City Birth Trauma Scale (CityBiTS-Pr) is a valid and reliable questionnaire for evaluating postpartum PTSD.
Health-related quality of life and functionality in primary caregiver of surviving pediatric COVID-19
Authors: Martins Fernanda , Gonçalves Fernanda T. , Imamura Marta , Barboza Daniela S. , Matheus Denise , Pereira Maria Fernanda B. , Marques Heloisa H. S. , Correa-Silva Simone , Montenegro Marilia M. , Fink Thais T. , Lindoso Livia , Bain Vera , Ferreira Juliana C. O. A. , Astley Camilla , Matsuo Olivia M. , Suguita Priscila , Trindade Vitor , Paula Camila S. Y. , Litvinov Nadia , Palmeira Patricia , Gualano Bruno , Delgado Artur F. , Carneiro-Sampaio Magda , Forsait Silvana , Odone-Filho Vicente , Antonangelo Leila , Battistella Linamara R. , Silva Clovis A. 
Published: June 2023

ObjectivesTo prospectively assess health-related quality of life (HRQoL), global functionality, and disability in primary caregivers of surviving children and adolescents after COVID-19.MethodsA longitudinal observational study was carried out on primary caregivers of surviving pediatric post-COVID-19 patients (n = 51) and subjects without COVID-19 (n = 60). EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and 12-question WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) were answered for both groups. The univariate regression analysis was carried out using SPSS (v 20) and significance was established at 5%.ResultsThe median duration between COVID-19 diagnosis in children and adolescents and longitudinal follow-up visits was 4.4 months (0.8–10.7). The median age of children and adolescents caregivers with laboratory-confirmed COVID-19 was similar to primary caregivers of subjects without laboratory-confirmed COVID-19 [43.2 (31.6–60.9) vs. 41.5 (21.6–54.8) years, p = 0.08], as well as similar female sex (p = 1.00), level of schooling (p = 0.11), social assistance program (p = 0.28), family income/month U$ (p = 0.25) and the number of household’s members in the residence (p = 0.68). The frequency of slight to extreme problems (level ≥ 2) of the pain/discomfort domain according to EQ-5D-5L score was significantly higher in the former group [74% vs. 52.5%, p = 0.03, OR = 2.57 (1.14–5.96)]. The frequency of disability according to WHODAS 2.0 total score was similar to those without disability and unknown (p = 0.79); however, with a very high disability in both groups (72.5% and 78.3%). Further analysis of primary caregivers of children and adolescents with post-COVID-19 condition (PCC) [n = 12/51 (23%)] compared to those without PCC [n = 39/51(77%)] revealed no differences between demographic data, EQ-5D-5L and WHODAS 2.0 scores in both groups (p &gt; 0.05).ConclusionWe longitudinally demonstrated that pain/discomfort were predominantly reported in approximately 75% of primary caregiver of COVID-19 patients, with high disability in approximately three-quarters of both caregiver groups. These data emphasized the prospective and systematic caregiver burden evaluation relevance of pediatric COVID-19.
Transformasi Atribut Menjadi Elemen Estetis Pada Kostum Olahraga
Authors: Musnur Irfandi 
Published: June 2023

Penggunaan produk Kostum jersey Olahraga menjadi varian gaya pada trend Fashion bagi kalangan masayarakat. Pengguna produk kostum ini telah merambah dibeberapa kalangan, baik anak-anak, remaja sampai pada orang tua. Menariknya adalah jersey pada dasarnya memiliki komponen-komponen atribut yang diproduksi sebagai tuntutan fungsi, kini hadir sebagai sebuah ornamen visual estetika pada Fashion. Penelitian ini mencoba melihat dari sisi yang berbeda, yakni bagaimana transformasi fungsi atribut jersey olahraga (atribut merupakan elemen-elemen yang tertera pada kostum olaharaga sebagai media fungsi penanda) menjadi atribut estetis pada Trend Fashion Olahraga. Hal ini akan diuraikan melalui identifikasi aspek-aspek fungsi baik visual, symbol, Phonogram, warna dan lainnya yang biasanya digunakan sebagai fungsi bertransformasi menjadi tampilan estetika pada produk Fashion Sport. Penelitian ini dilakukan dengan Metode Kualitatif Deskriptif dengan pendekatan analisa wacana. Identifikasi ini dilakukan melalui pendekatan analisa unsur-unsur visual atribut kostum olahraga, khususnya pada sampel kostum Sepak bola dan Baseball. Kostum ini menjadi sampel identifikasi berdasarkan analisa trend Fhasion yang sering muncul pada Masyarakat. Melalui penelitian ini, berupaya menyampaikan perspektif konsep transformatif Fungsi menjadi estetika dalam fenomena Kostum Sport sebagai trend Fhasion. Istilah “sporty” dalam Fhasion kostum olahraga, dihadirkan melalui asosiasi elemen atribut yang pada dasarnya merupakan Fungsi Penanda pada kostum Olahraga yang sebenarnya. Atribut tersebut seperti nomor punggung, logo, phonogram, elemen warna, dan bentuk dari kostum itu sendiri. Trend fhasion olahraga meminjam atribut tersebut untuk menghadirkan nuansa gaya Sporty pada mode trend busana.
Zero Trust: The Magic Bullet or Devil’s Advocate?
Authors: Salminen Helvi 
Published: June 2023

The concept of Zero trust was first introduced in mid 1990’s, and has gradually attracted increasing attention. This approach to building organizations’ information system infrastructures has been developed as response to increasing interaction and interconnection of information systems. Along with organizational boundaries have become less clear with the new business models where a business process exceeds the organizational boundaries, also the boundaries of information systems are no longer clear. In this interconnected world the purely perimeter-based security model defining zones of trusted entities inside the perimeter and the untrusted external world outside the perimeter no longer serves the needs of new business models. And the combination of complex technology and sophisticated attack methods it is no longer possible to be sure that all system components and actors inside the perimeter can be trusted. The Zero trust approach brings the sophisticated controls from the perimeter to the entire system. The core idea can be expressed with the four words “never trust, always verify”. No system component is by default trusted , and one-time verification is not sufficient – access to a resource must be verified at each connection attempt. Mutual authentication of the communicating parties is in the core of the approach. But does the zero trust approach have unwanted side-effects? The complexity of the system increases when new control layers are built, and system complexity can increase the possibility of configuration errors. Can there be other side-effects as well? The need for trust does not disappear even when the systems are built on the zero trust principles. When studying the zero trust approach the author started thinking what would happen in human interaction and organizational co-operation if they are based on or partly apply the zero trust approach. And the scenarios were quite gloomy. But is this only a nightmare or already at least partly present in our reality? This article describes the zero trust approach and its applicability to technical environments. The second part present scenarios of the impacts which application of zero trust principles could have – or maybe already has - in human communication and organizational relationships.
Developing Cybersecurity in an Industrial Environment by Using a Testbed Environment
Authors: Simola Jussi , Savola Reijo , Frantti Tapio , Takala Arttu , Lehkonen Riku 
Published: June 2023

Critical infrastructure protection requires a testing environment that allows the testing of different kinds of equipment, software, networks, and tools to develop vital functions of the critical industrial environment. Used electrical equipment must be reliable, capable and maintain a stable critical industrial ecosystem. An industrial business needs to develop cybersecurity capabilities that detect and prevent IT/ICT and OT/ICS threats in an industrial environment. The emerging trend has been to create security operations center (SOC) services to detect ICS-related threats in enterprise networks. The energy supply sector must consist of crucial elements for safe business continuity and supply chain management in the industrial sector. Threats have changed into a combination of threat types. Hybrid threats may prevent everyday industrial activities, processes, and procedures so that supply chain problems may become long-lasting and affects business continuity management.
The project CSG belongs to the (Cybersecurity governance of operational technology in the sector connected smart energy) research project consortium of Business Finland’s Digital Trust Programme.
The first research paper regarding the CSG (Cyber Security Governance) project concentrates on the applied theory background of this project. The research provides a research approach for investigating cyber security at the operational and technical levels. It answers the questions of where to concentrate on OT-related cyber security research and how we aim to deploy a testbed to develop a governance model in the CSG project. The study's primary purpose is to describe the operating OT-SOC environment and analyze system requirements for optimizing situational awareness in the testbed environment.
Scintillation properties of Er3+-activated BaO–Nb2O5–TeO2 glasses
Authors: Kawano Naoki , Okazaki Kai , Takebuchi Yuma , Fukushima Hiroyuki , Kato Takumi , Nakauchi Daisuke , Kagaya Fumito , Shinozaki Kenji , Yanagida Takayuki 
Published: June 2023

Abstract
Recently, glasses have gained great interest for use as scintillators owing to lots of industrial benefits such as ease of producing customizable shapes and low production cost. Herein, the Er3+-activated BaO–Nb2O5–TeO2 glasses were fabricated for the development of NIR glass scintillators. The Er3+-activated BaO–Nb2O5–TeO2 glasses exhibited efficient photoluminescence and scintillation that originated from the 4f→4f transition of Er3+. Their quantum yields in photoluminescence were 80% (0.1%Er2O3), 81% (0.5%Er2O3), and 61% (1.0%Er2O3). Further, an almost linear correlation between an X-ray dose rate and NIR scintillation intensity was observed in the 0.5–5000 mGy h−1 dose rate range. Interestingly, the lowest detectable dose rate limit (0.5 mGy h−1) was lower than that of Er-doped Bi4Ge3O12 and Nd-doped GdVO4 single crystals. Further, afterglow levels of the non-doped and Er3+-activated BaO–Nb2O5–TeO2 glasses were about 600 ppm. The observed NIR scintillation properties indicated that the Er3+-activated tellurite glasses should be promising compounds for NIR-emitting scintillators.
Empowerment for Increasing of White Oyster Mushroom Cultivation to the Next Level
Authors: Purwatiningsih Rini 
Published: June 2023

This service partner is a white oyster mushroom cultivator and is classified as an economically productive partner, domiciled in Bedian Hamlet, Jambesari Village, Jambesari Darus Sholah District, Bondowoso Regency. He was domiciled in Bedian, Jambe Sari Village, Jambesari Darus Sholah District, Bondowoso Regency. Service Objectives: (1) partner to be more productive and have high entrepreneurial value (2) student can be improve the experience of studying outside the campus as one of the MBKM implementations. Implementation of activities includes: (1) Planning, (2) Administration preparation and Team coordination, (3) Continuous assistance from pre-production to post-production, (4) Evaluation (5) Controlling. The results of the activities: (1) Overcoming constraints on kumbung conditions, (2) Overcoming obstacles during the baglog filling process, (3) Overcoming obstacles in the baglog sterilization process, (4) Overcoming obstacles in the process white oyster mushroom production, (5) Overcoming obstacles in the post-production process, (6) providing added value to the production of white oyster mushrooms into mushroom chips.
مرافقة العود المنفرد للغناء العراقي
Authors: أ.د. حسام يعقوب  
Published: June 2023

يتكون البحث من أربعة فصول مع قائمة بالمصادر والملاحق كالآتي:
يتناول الفصل الأول الإطار المنهجي للبحث إذ يبدأ بعرض مشكلة البحث التي تلقي الضوء على اشتهار أهل العراق منذ أقدم الأزمنة برقة شعورهم ودقة فكرهم وحسن وصفهم للطبيعة والبيئة التي يعيشون فيها، اذ تحتل الموسيقى والغناء مكانة متميزة في ثقافة سكانه وتراثهم فوجدت آلة العود، كآلة موسيقية منذ العصر الأكدي (2350 ـ2170 ق.م) حيث كانت تابعة للغناء، وهي اليوم أما وسيلة للبناء اللحني أو مرافقة (مترجمة) له.
سرد الباحث بعضا من مراحل تطور هذه الآلة سواء في العصر الجاهلي أو في عصر الإسلام ودور العازفين الأوائل والمنظرين من الفلاسفة. وقد اسهم تدريس هذه الآلة الموسيقية في العصر الحديث في تطوير طرائق العزف والاداء (والذي تطلب تطويرا في صناعة تلك الآلة الموسيقية لتتناسب مع المهارات في العزف) التي تطورت وتوسعت بفتح آفاق جديدة انتقل بها دور آلة العود من الاداء الجماعي (مع الفرقة الموسيقية ) الى الاداء المنفرد (من خلال ما اضافه الشريف محي الدين حيدر) الى طلبته والعمل على جعل العزف على آلة العود الفن القادر على تخطي الحدود التطريبية الى آفاق التعبير الفني ,من خلال المزج بين التقنية وطريقة العزف التقليدي المرافق للغناء, وهذا المزج لم يظهر بشكل واضح للعيان الا لدى البعض من العازفين الذين رافقوا الغناء واستمدوا خبراتهم ممن سبقهم (من مدرسي آلة العود ) حيث استخدموا طرقاً منسجمةً مع طبيعة الاغنية المنفردة , مما أضفى عليها جمالية مبتعدةً عن المرافقة التقليدية (التي جعلت من آلة العود كآلة مترجمة للغناء), ودراسة اوجه الاشكال الادائية للعود المنفرد .
دراسة مقارنة بين تطبيقات التصميم الجرافيكي
Authors: م. د. راقي صباح نجم الدين  , م. لينا عماد فتحي  
Published: June 2023

يُعد الحاسوب آداة لا غنى عنها في صناعة التصميم الجرافيكي. وبالنسبة إلى المحترفين من مصممي الجرافيك فإن أجهزة الحاسوب وما لها من تطبيقات البرمجيات تعد بصورة عامة من الأدوات الأكثر فعالية في مجال الإبداعي الفني، من الطرائق التقليدية. فاستخدام الحاسوب يتطلب تدريباً لكي يسمح للمستخدم بالتركيز على التصميم وليس الأداة، الأمر الذي من شأنه أن ينقل المصمم من خلال العملية الإبداعية بسرعة أكبر لكن تعقيد الحاسوب يمكنه إعاقة هذه العملية بجعل التركيز ينتقل من المنتج إلى التقنية، وهذا ما يمكننا أن نراه يحدث في الكثير من الأحيان حيث تحظى بعض التصاميم بالتقدير ليس لجودتها بل للتقنيات الرقمية التي استخدمت في التعبير عن التصميم. وفي حالات كثيرة يكون فيها المصمم يجيد العمل على تطبيق واحد ولكن حينما يتطلب الامر ان يعمل على تطبيق آخر تصادفه مشكلة وهي صعوبة تعلم التطبيق الجديد بعد التعود على التطبيق الاول. وتأتي هذه الدراسة لتسلط الضوء على اثنين من اشهر تطبيقات التصميم الجرافيكي اذ تهدف هذه الدراسة الى الكشف عن جوانب التشابه والاختلاف بين التطبيقين من خلال مقارنة العمل في بيئتي التطبيقين ومقارنة قوائم وصناديق ادوات التطبيقين، اتبع الباحثان الملاحظة والمقارنة من خلال تجربة العمل في التطبيقين، حيث كانت ابرز معطيات البحث هي ان المصطلحات والمفاهيم في (ادوبي إليستريتور) و(كوريل درو) تختلف في بعض المزيات. وفي بعض الحالات، قد تكون المزايا متماثلةَ في التطبيقين ولكنها موصوفة بإستعمال مصطلح مختلف. في الحالات الأخرى، يستعمل (كوريل درو) مصطلحات ومفاهيم جديدة ليس لها مكافئ في (ادوبي إليستريتور).
تأثير التدريب المركب على وفق النشاط الكهربائي في القدرة الحركية لعضلات الساقين لعدائي فعالية ركض 200 متر للشباب
Authors: أ.م.د.حيدر فائق الشماع  , د.علاء جابر عبود  , بلال علي أحمد  
Published: June 2023

المقدمة وأهمية البحث - اختار الباحث واحد من أكثر الأساليب التدريبية التي تساعد في تطوير الكفاءة الانقباضية للعضلات العاملة وهو التدريب المركب الذي اثبت نجاحات واسعة لدى معظم المدربين والباحثين الذين استخدموه في تطوير القدرة العضلية، اما أهمية البحث فتظهر في أجراء دراسة للتعرف على اكثر العضلات مشاركتا في العمل من خلال النشاط الكهربائي (جهاز EMG) للأداء الحركي لمرحلتي البدء من الجلوس و ومرحلة التدرج بالسرعة لفعالية ركض 200 متر التي تعد اهم المراحل الحاسمة في تحقيق الفوز بالاركاض السرعة.