bluuebunny/crossref_metadata_2025 huggingface dataset:
Role of Curcumin in Reducing Toxicities Associated With Mucosal Injury Following Melphalan-Based Conditioning in Autologous Transplant Setting
Authors: Punatar Sachin , Katti Kritika , Rajamanickam Deepan , Patil Pravin , Dhakan Chetan , Bagal Bhausaheb , Gokarn Anant , Bonda Avinash , Nayak Lingaraj , Gurjar Murari , Kannan Sadhana , Chiplunkar Shubhada , Gota Vikram , Khattry Navin
Published: April 2022

Mucositis is nearly inevitable following high-dose chemotherapy. Several pro-inflammatory cytokines play a role in pathogenesis of mucositis. Curcumin inhibits inflammatory cytokines through inhibition of nuclear factor kappa-β. We studied the effects of curcumin on the acute toxicities and inflammatory cytokines following melphalan (200 mg/m2) for autologous hematopoietic stem cell transplantation (HSCT) for myeloma. The control group (first 10 enrolled patients who received standard supportive care) was compared with curcumin group (next 30 patients who received chewable curcumin lozenges, 4 g twice daily from 2 days before melphalan till day +28 along with standard supportive care). The toxicities were recorded as per World Health Organization (WHO) criteria and CTCAE v3.0 as applicable. Cytokine profiling was done in both groups at similar time points. In the curcumin group, there was significant decrease in grade 3/4 vomiting (3% vs 40%, P = 0.01) and total parenteral nutrition use (47% vs 90%, P = 0.026). Grade 3/4 mucositis (43% vs 60%) and diarrhea (33% vs 70%) were also less, but not statistically significant. This coincided with 3.2-fold lower area under the concentration time curve (AUC) of IL-8 from day –3 to day 14 in curcumin group compared with control group ( P = 0.039). We conclude that curcumin mitigates toxicities of high-dose melphalan, possibly through IL-8 modulation. Randomized studies are warranted to explore benefits of curcumin in HSCT.
Fake News in Brazil's 2018 Presidential Elections: A Systems Theory Approach to Judicial and Legal Responses
Authors: Loschiavo Leme de Barros Marco Antonio , Fucci Amato Lucas , Tognini Saba Diana , Pedigoni Ponce Paula
Published: April 2022

This article adopts an approach from social systems theory to map the legislative and judicial responses produced by Brazilian law in light of the 2018 presidential election in Brazil, a political event marked by the mass dissemination of fake news. The study applies social systems theory to observe and interpret the legislative process in relation to a Draft Statute on Fake News which is part of a regulatory movement concerning digital communications and personal data in Brazil. The article combines this with observations on case law from the Superior Electoral Court regarding fake news dissemination during the 2018 presidential election. The results of these analyses demonstrate the difficulty of regulating fake news in Brazil and the problems with a legal framework based on the deference of the Judiciary to legislative decisions; its openness to technology experts; and the adoption of “regulated self-regulation” as a way of building an interface between legal and political national systems and transnational digital platforms.
Customers’ Attitude Towards Vegan Products Consumption and Its Impact on Purchase Intension: An Indian Perspective
Authors: Malik Reena , Jindal Tanvi
Published: April 2022

Increasing environmental degradation, animal cruelty and health consciousness has drawn attention towards environment-friendly eating habits and adopting a vegan lifestyle. This study aims to explore the impact of health awareness, animal welfare, environmental concern and subjective norms’ antecedents on customers’ attitude towards the consumption of vegan products and its impact on purchase intention. By utilizing a structured questionnaire, data has been collected from 214 Indian respondents via Facebook vegan groups. The study takes into consideration subjective and moral determinants, and it checked their influence on veganism by applying structural equation modelling. Results revealed that subjective concerns have no influence on attitude and that, rather, moral concerns do have such an influence. Attitude towards vegan product consumption influences purchase intension positively. The study concluded with implications for policy makers, social workers, marketers and academicians.
A Study on Employee Motivational Factors and Employee Engagement in South India: The Moderating Role of Work from Home
Authors: Ross Dhyana Sharon
Published: April 2022

This research article focuses to find how employee motivational factor influences employee engagement (EE). The key objectives of the research were aimed to identify the key employee motivational factor, to determine the extent of influence motivational factor has on EE and to find the moderating role of work from home (WFH) on employee motivational factors and EE. The study examined multinational companies of information technology and information technology enabled services sectors in southern parts of India. The sample comprised of 506 respondents. An adapted questionnaire measured on Likert scale were used for collecting data. The obtained result showed that employee motivational factor influences EE and WFH moderates employee motivational factors and EE.
Characterizing the Over-indebted: An Event History Analysis of Financial Diaries
Authors: Rao Sachit , Parthasarathy Navitha
Published: April 2022

Low-income households (HHs) face vagaries in income and expenses. These often require the HH to borrow and can cause the HH to become over-indebted. Financial Diaries capture information on incomes, expenses, loans, and shocks with fine granularity and at frequent intervals. In this article, such a dataset is analyzed using the event history analysis approach in order to quantify the risk of HHs becoming over-indebted. Over-indebtedness is defined using two rubrics: monthly debt-to-income ratio and sacrifices made by the HH. The results of this analysis may be used by institutions to customize financial instruments based on the characteristics of an HH.

JEL Codes: C410, C810, C830
The Airblue Flight 202: Communication and Decision Making in Crisis
Authors: Khalid Afaf , Ahmad Ghufran
Published: April 2022

The case study on Airblue chronicles the events that led to the biggest plane crash in the aviation history of Pakistan. Airblue flight 202 destined from Karachi to Islamabad crashed while attempting to land under adverse weather conditions. The flight carried 146 passengers and 6 crew members; all died in the crash. Later investigations identified gross errors in judgment and decision making by the cockpit crew and unprofessional attitude as the sole cause of the crash.

The case study documents the events that unfolded prior to the crash and identifies a number of major factors that are important while communicating and making decisions under critical situations. It touches upon the themes of superior-subordinate communication and relationships, empowerment, sense of responsibility under life-threatening situations, making sense of crises, the role of initiative, self-confidence, and reliance on others. The case is suitable to be taught on topics dealing with communication, decision making, teamwork, and leadership in crises, at the graduate level (MBA) and in executive training courses on team building, leadership and crisis management. It highlights the situations which emerge as crises and where teamwork is paramount for the effective achievement of goals. Furthermore, it focuses on the possible relapses when effective teamwork and communication are not in play.
No Virus on Me: The Indian Ways of Managing the COVID-19 Pandemic: Marine to Mountain
Authors: Bhattacharyya Jishnu , Dash Manoj Kumar , Kundu Soumyadeep , Sakshi Shivam , Bhattacharyya Kamalika , Kakkar Karina Bhatia
Published: April 2022

The case is about the coronavirus disease 2019 (COVID-19) pandemic, and India’s ‘midstream’ social marketing strategies and other strategic approaches to battle the notorious virus, the first known case of which was identified in Wuhan, China, in December 2019. The art and science of social marketing were exploited to promote a healthy lifestyle as a precautionary measure against COVID-19 infection through non-pharmaceutical interventions. Social marketing campaigns promoting healthy behaviour, improving psychological health and ensuring mass well-being were implemented to manage the huge Indian population in the metro cities as well as in the remotest communities in villages during the pandemic. The case study discusses the health intervention and promotion strategies and other preparedness adopted by various stakeholders in India. The case study also discusses the history and experience of severe past health threats in India and what those experiences contributed to India’s preparedness. The crisis worsened when the citizens could not cope with psychological and economic problems; a section of the population disobeyed the government guidelines. The government faced capacity and resource constraints. The case study ends with a dilemma on whether to continue with the lockdown efforts or ease restrictions. The government needs to decide on strategies to ensure the well-being of its citizens and ways to manage citizens and businesses of all forms. The consequence of the decision had huge economic, health as well as governance implications. The case study will provide practitioners with reference to the potential of social marketing and other crisis management strategies to address a complex problem featured with aleatory as well as epistemic uncertainty. The case study is timely and may serve as a reference to the rest of the world as an example to deal with similar problems at an industrial scale.
Climate Refugees in India: A Wake-up Call for an Inclusive Policy
Authors: Sawant Nagesh H. , Sanjeev Aparna
Published: April 2022

Earth’s climate is changing drastically and its effect is being felt over the entire world. Some nations suffer more because of several geographical and demographical factors. People have started migrating from their homeland because of the disasters occurring due to climate change. These migrants commonly known as climate refugees are homeless and without rights. However, the United Nations High Commissioner for Refugees (UNHCR) has recognised the need to protect climate refugees and has taken initiatives to relocate the climate refugees. Recently, the United Nations Human Rights Committee (UNHRC) ruled that no country can send back a refugee whose life is at imminent threat due to climate change. Even though this decision is non-binding on the countries, it puts an international pressure on countries to act soon concerning climate refugees. India is one of the countries which might face a great migrant influx from neighbouring countries. The Sundarbans 1 Delta of Bangladesh is one of the high-risk areas and it is estimated that around 50–120 million climate refugees might migrate to India. India needs to be prepared for this crisis and develop a sound refugee policy framework.  Against this backdrop, this research article aims to highlight legal issues relating to the protection of climate refugees in India and suggests policy measures to overcome the crisis.
The Complexity of Contextuality: A Case Study on Vertical Housing Facilities in Surabaya, Indonesia
Authors: Adianto Joko , Rahman Mohammad Fazrin , Gabe Rossa Turpuk , Christina Adinda
Published: April 2022

Vertical housing has been considered an effective way to provide low-income housing in many megacities. As part of an effort to implement contextual architectural design, vertical housing projects in Surabaya, East Java, Indonesia, incorporated shared kitchens and bathrooms as observed in Indonesian kampong (slum) settlements. However, the residents eventually converted their shared kitchen spaces to other uses and constructed kitchens in their individual units. This research study investigated the nature of and reasons for such transformations through quantitative and qualitative data collection among residents of three vertical housing projects in Surabaya. We found that disputes over upkeep and rules of use, along with perceived invasions of privacy, precipitated the abandonment of shared kitchens. Residents could not retrofit their shared bathrooms for structural reasons, but they renegotiated a payment system (based on flat fees rather than actual usage) that they considered unfair. Interviews revealed significant differences in implementation between the shared facilities in vertical housing and the voluntary shared arrangements in the kampongs. The facility and management modifications that occurred in vertical housing, which applied bottom-up contextual design by considering users’ needs and sensitivities, indicate the complexity of applying a contextual design process into practice.
Impacts of Climate Change on Fishing Villages in the North Vietnam
Authors: Ngoc Nguyen Thi , Binh Ngo Xuan , Ha Nguyen Thi Thu
Published: April 2022

This article assesses the impact of climate change on the fishing activities of businesses, households and fishermen in the Northern coastal villages of Vietnam. From the data published by the state agencies and case studies in some fishing villages in the Northern region, this article assumes that the coastal fishing villages has a long history, making important contributions to the economic and social development. In recent years, fishing activities have expanded but are also affected by the consequences of climate change. Aware of this problem, businesses, households and fishermen have many measures to respond, but the effectiveness is still not high. Therefore, the study suggests that the government should pay more attention to improving the ability to predict early, accurately the location and evolution of rain, storm, etc. Exploiters need to be more proactive in equipping rescue equipment on ships and boats when going out to sea.
The Relationship Between Disaster Risk Perception and Multiple Deprivation: A Study on Rangpur City, Bangladesh, Using Geospatial and Statistical Approaches
Authors: Rahman Md Zakiur , Atun Funda , Martinez Javier
Published: April 2022

Rapid urbanization and multiple deprivation are making cities more prone to numerous disasters. This study examines the relationships between disaster risk perception and multiple deprivation in the Rangpur city Corporation area in Bangladesh. Enhanced understanding of this relationship would bring valuable insights for planning and policies, especially pertinent for vulnerable communities in the Global South. Rangpur city is located in a deprived zone of Bangladesh that is highly prone to earthquake and fire hazards, and the population’s low level of risk perception might exasperate their vulnerability to earthquakes and fire. This study’s research methods include an index of multiple deprivation, earthquake and fire risk perception index, geographic information system (GIS)-based mapping, statistical analysis and questionnaire surveys. The statistical methods are correlation analysis, factor analysis, Kaiser–Meyer–Olkin test and cross-table analysis. The results of the study show that there is no statistically significant relationship between disaster risk perception and multiple deprivation; however, cross-table analysis revealed a relationship between risk perception and deprivation. The study identified the hot spots of hazard risks and deprivation in Rangpur city. To the best of our knowledge, this is the first effort to investigate the relationship between disaster risk perception and multiple deprivation.
Do Amenities and Economic Factors Affect Migration? Empirical Evidence from Indonesian Cities
Authors: Hakim Arif Rahman , Nachrowi Nachrowi Djalal , Handayani Dwini , Wisana I. Dewa Gede Karma
Published: April 2022

Indonesia is one of the developing countries with a distinct migration pattern because it is still concentrated in certain areas due to uneven development. The literature informs that not only economic factors influence migration but also amenities. The article examines the role of amenities and economic factors on Indonesia’s cities migration. The results reveal that cities in Java have higher amenities and are still the most popular migration destinations, while migrants can consider cities outside Java if they are included in the high amenities category and the provincial capital. Migrants are also interested in cities with abundant amenities, even if the economic compensation is not high. Our results found that amenities, minimum wages, gross regional domestic product, tertiary sector and growth contributed to migration. The study confirms that amenities other than economic factors influence Indonesian city’s migration. We suggest that the city government prioritize the provision of quality amenities and the creation of a better city economy.
Effect of Reflective Practices on Student Learning in Higher Education—A Real Life Approach
Authors: Yadav Devinder K. , Bhatia Dinesh
Published: April 2022

Validation of ideas are of paramount importance in STEM fields. Learning and converting ideas into practical application is the main purpose of technical education. Aviation is a highly safety sensitive field where confusion and mistakes are not acceptable. This brings serious challenges for academia that provides higher education in this field. A yearlong observation of the reflective practices was done at an Australian university while teaching aviation students to analyse outcomes of reflection on teaching and learning. Reflection provides a powerful opportunity to a teacher in improving teaching qualities and to identify training needs for enhancing teaching capabilities.
Japanese Graduate Students’ Experiences in Online International Development and Peace Through Sport Courses Using English-Medium Instruction During the COVID-19 Pandemic
Authors: Oishi Junko , Sato Takahiro , Miller Ryan T. , Nagata Shinichi , Fuchikami Maho , Shimizu Satoshi , Matsumoto Tsuyoshi , Yamaguchi Taku , Kim Satbyul Estella
Published: April 2022

The purpose of this study was to investigate five Japanese graduate (master's level) students’ experiences in online courses in international development and peace through sport that used English as the medium of instruction. The study was situated in the framework of andragogy theory and used a descriptive-qualitative design using an in-depth, semistructured interview approach using online oral and written interviews. Three emergent themes were established. These recurrent themes were (a) learning online specialized content using English as a second language, (b) students’ struggles in group projects through online education, and (c) students’ opinions about the improvement of online education. To better support Japanese graduate students’ online learning, this study encourages academic departments, administrators, and faculty to better design appropriate courses and online activities. This will contribute to a greater appreciation for the richness of sports development and peace and to increasing the availability of meaningful academic and social experiences for graduate students at Japanese universities.
Toward a science of experience: Outlining some challenges and future directions
Authors: Valenzuela-Moguillansky Camila , Demšar Ema
Published: April 2022

In recent decades, empirical study of experience has been installed as a relevant and necessary element in researching cognitive phenomena. However, its incorporation into cognitive science has been largely done by following an objectivist frame of reference, without reconsidering the practices and standards involved in the process of research and the interpretation and validation of the results. This has given rise to a number of issues that reveal inconsistencies in the understanding and treatment of some crucial aspects of first-person research. In this article, we will outline a research direction aiming at contributing to the establishment of a framework for the study of experience that addresses these inconsistencies. Specifically, we will identify some challenges facing the study of experience—in particular those linked to the understanding of memory, expression and description, and intersubjectivity in exploring experience—and propose to reframe them under the epistemological framework of the enactive approach. Moreover, we will explore the prospect of gaining insight into theoretical and methodological strategies for dealing with these issues by extending our vision beyond the field of cognitive science to its neighboring fields, focusing in particular on the field of somatic practices.
The Psychometric Assessment of Empathy: Development and Validation of the Perth Empathy Scale
Authors: Brett Jack D. , Becerra Rodrigo , Maybery Murray T. , Preece David A.
Published: April 2022

Empathy, the ability to infer and share others’ affective states, plays a vital role in social interactions. However, no existing scale comprehensively assesses empathy’s cognitive and affective components across positive and negative emotional valence domains. This article explores the latent structure of the empathy construct and attempts to remedy past measurement limitations by developing and validating a new 20-item self-report measure, the Perth Empathy Scale (PES). In Study 1 ( N = 316), factor analyses revealed a coherent empathy construct comprised of cognitive and valence-specific affective components. Study 2 ( N = 331) replicated this factor structure, showed measurement invariance between males and females, and highlighted the importance of assessing negative and positive emotions in empathy. The PES showed convergent and discriminant validity from comparisons with alexithymia and other empathy measures. Overall, this article empirically establishes a conceptually clear structure of the multidimensional empathy construct, which the PES reliably and validly measures.
Examination of the Generalizability of Underreporting Detected by the MMPI-2-RF in a Correctional Sample
Authors: Keen Megan A. , Lee Tayla T. C. , Pscheid Kelsey , Forbey Johnathan D.
Published: April 2022

It is relatively unclear if underreporting (UR) detected by Minnesota Multiphasic Personality Inventory–2–Restructured Form (MMPI-2-RF) L-r (Uncommon Virtues) and K-r (Adjustment Validity) scale scores generalizes to score distortion on criterion measures differently based on test-takers having scored highly on L-r, K-r, or both. Thus, this study reanalyzed the correctional sample of 632 men previously presented by Forbey and colleagues and defined UR groups as high scores on L-r alone ( n = 89), K-r alone ( n = 45), or both ( n = 29). Groups were compared on selected MMPI-2-RF and criterion scales assessing internalizing, externalizing, and thought dysfunction difficulties using analysis of variance (ANOVA) and post hoc tests. Results suggested that UR generalized to score distortion on collateral measures, with K-r outperforming L-r in the prediction of this generalizability on all but measures of specific externalizing difficulties. However, having elevations on both L-r and K-r resulted in the strongest pattern of generalizability.
Incidence and Determinants of Chemotherapy Associated Thromboembolic Events among Ethiopian Patients Treated for Solid Malignancy: A Retrospective Cross-Sectional Study
Authors: Yabeyu Abdella Birhan , Hussen Shemsu Umer , Tigneh Wondemagegnhu , Fentie Atalay Mulu
Published: April 2022

Venous thromboembolism is a common problem in patients treated for cancer, although the reported incidence varies widely between studies. This was the first study in its kind in Ethiopia and aimed to assess the incidence and determinants of chemotherapy associated thromboembolic events among patients treated for solid malignancy. An institution-based retrospective cross-sectional study was conducted from 1st March to 1st June, 2019 at adult oncology center of Tikur Anbessa Specialized Hospital. Systematic random sampling technique was employed to recruit 423 study participants. Patients who have received at least a single cycle of any chemotherapy regimen were included in the study. Khorana risk assessment tool was used to predict chemotherapy associated thrombosis. Descriptive statistics were used to summarize the data while multivariable logistic regression was employed to explore associations among variables of interest. The median age of study participants was 43 years, which ranged from 14 to 83 years. Majority of the study participants were treated for breast cancer. Thromboembolic events encountered in 43(10.2%) of patients, from which the commonest one being deep venous thrombosis 36 (85.7%), followed by myocardial infarction 5(11.9%). In multivariable logistic regression, blood transfusion, a primary site of cancer with gastrointestinal malignancy and performance status showed statistically significant association towards the occurrences of thromboembolic events. The incidence of chemotherapy associated thromboembolic events among patients treated for solid malignancy was comparable to other studies. Hence, other prospective randomized trials are needed to see the importance of thrombo-prophylaxis in such high-risk patients.
An Implementation of Culturally Responsive Protective Factors to Meet the Needs of Girls of Color in Gifted and Talented Education
Authors: Middleton Tanya J. , Ford Donna Y.
Published: April 2022

This article presents an overview of factors that contribute to the inequitable underrepresentation of girls of color in gifted and talented with an emphasis on Blacks since they are most frequently absent. After presenting this national context, the authors present Ford’s Female Achievement Model for Excellence as a gendered and racial culturally responsive resource for effectively addressing the intersectional needs and development of students who are female and gifted and talented.
Interdisciplinary Learning: Connecting Language and Literacy Across the Curriculum
Authors: Mora-Flores Eugenia , Kaplan Sandra N.
Published: April 2022

This article describes methods for operationalizing the concept of interdisciplinarity. The methods respond to the characteristics of giftedness and strategies of differentiation. In selecting and using an interdisciplinary strategy, educators need to consider the compatibility of the purpose or objective of interdisciplinarity to the curriculum and/or instructional objective or goal, readiness of learners, availability of resources, and allocation of time for teaching and learning. Moreover, teachers and students need to value open-ended learning and the value of inquiry.
Global vibration control of nonlinear energy sinks
Authors: Wang Guo-Xu , Ding Hu , Chen Li-Qun
Published: April 2022

Although a linear vibration absorber (LVA) or nonlinear energy sink (NES) can effectively mitigate the vibration of a primary system in harmonic excitation, the amplitude of the absorber can be very large. Using the differential evolution algorithm, this paper pioneers the global control of the primary system and absorber to achieve decent vibration mitigation and decrease the global response. The results show that the maximum amplitude of the primary system and absorber can be controlled at the same level, and the global control strategy does not change the resonance frequency of the primary system. Compared with the LVA, the NES has similar vibration mitigation effects, mass ratio, and damping values. However, different from the LVA, the NES can achieve optimal mitigation effects in multiple optimal combinations of spring stiffness and geometry parameter and have smaller frequency responses in large excitation. Therefore, this paper proves the superiority of the NES in global vibration control.
State Policies and Buprenorphine Prescribing by Nurse Practitioners and Physician Assistants
Authors: Harrison Jordan M. , Kerber Rose , Andraka-Christou Barbara , Sorbero Mark , Stein Bradley D.
Published: April 2022

Nurse practitioner (NP) and physician assistant (PA) prescribing can increase access to buprenorphine treatment for opioid use disorder. In this cross-sectional study, we used deidentified claims from approximately 90% of U.S. retail pharmacies (2017–2018) to examine the association of state policies with the odds of receiving buprenorphine treatment from an NP/PA versus a physician, overall and stratified by urban/rural status. From 2017 to 2018, the percentage of buprenorphine treatment episodes prescribed by NPs/PAs varied widely across states, from 0.4% in Alabama to 57.2% in Montana. Policies associated with greater odds of buprenorphine treatment from an NP/PA included full scope of practice (SOP) for NPs, full SOP for PAs, Medicaid pay parity for NPs (reimbursement at 100% of the fee-for-service physician rate), and Medicaid expansion. Although most findings with respect to policies were similar in urban and rural settings, the association of Medicaid expansion with NP/PA buprenorphine treatment was driven by rural counties.
The effect of high-power ultrasound pretreatment on drying efficiency and bioactive compounds of chokeberry (Aronia melanocarpa L.)
Authors: Görgüç Ahmet , Gençdağ Esra , Demirci Kardelen , Vayiç Aylin , Yılmaz Fatih Mehmet
Published: April 2022

Chokeberry (aronia) fruit is a rich source of bioactive compounds with various health benefits. However, it has a limited shelf life and a firm (tight) structure that makes it difficult for moisture transfer during drying. Therefore, the aim of the study is to investigate the effects of high-power ultrasound pretreatment (550 W, 30 min) and air drying temperature (65, 70 and 75 °C) on the drying rate and bioactive compounds of chokeberry fruit. Accordingly, chokeberries were dried directly or after ultrasound pretreatment, and the retention rate of bioactive properties, i.e., total phenolic, flavonoid and monomeric anthocyanin contents along with antioxidant capacity values, were examined. The required time for drying as well as the activation energy values were significantly lower in ultrasound treated samples. Logarithmic and Midilli models exhibited the best fit for drying kinetics of samples. The pretreatment led to significantly lower moisture content and aw values. Compared to fresh sample, the highest retention rate for some bioactive properties was found in ultrasound pretreated sample dried at 75 °C. The ultrasonication also reduced the electricity consumption (kWh) in all temperature levels of drying operations. As a conclusion, the ultrasound pretreatment prior to drying had dual role by facilitating drying kinetics and by providing higher bioactive contents.
Exploring the Definition of “Similar Toxicities”: Case Studies Illustrating Industry and Regulatory Interpretation of ICH S6(R1) for Long-Term Toxicity Studies in One or Two Species
Authors: Prior Helen , Clarke David O , Jones David , Salicru Eleni , Schutten Melissa M , Sewell Fiona
Published: April 2022

ICH S6 (R1) states that safety evaluation of biotherapeutics should normally include 2 relevant species when available (i.e., a rodent and non-rodent species in which the test material is pharmacologically active), at least for short-term toxicology studies (generally supporting Phase I trials). For subsequent long-term toxicology studies (e.g., chronic studies up to 6 months dosing duration), there are options to reduce to only one species when justified, including when the mechanism of action of the biologic is well-understood or the toxicity findings in the short-term studies are “similar” in both the rodent and non-rodent species. Across the industry, around 25 to 33% of biologics assess multiple species within short-term toxicity studies but it is often unclear how different companies and regulators are applying the ICH S6 (R1) principles of “similar toxicity profiles” to progress with either 1 or 2 species in the long-term studies, in particular whether the absence of toxicities is considered within this definition. Sponsors may potentially continue to use 2 species to avoid regulatory risk and potential delays in development timelines, representing missed opportunities for reducing animal use, particularly of non-human primates, during drug development.

This article summarizes presentations from a symposium at the 41st Annual meeting of the American College of Toxicology (ACT) in November 2020, in which industry case studies and regulatory perspectives addressed considerations and decisions for using 1 or 2 species for long-term toxicity studies, highlighting any common themes or experience that could be applicable for use in future decision-making.
Trocar-assisted flanged transconjunctival intrascleral sutureless intraocular lens fixation
Authors: GamalElDin Sherif A , ElShazly Malak I , Salama Marwa M
Published: April 2022

Purpose

To study the safety and efficacy of 25-gauge trocar-assisted flanged intrascleral sutureless IOL fixation in patients with insufficient posterior capsular support.

Methods

Five aphakic eyes with capsular insufficiency were included in this prospective interventional case series study, at Dar El Oyoun Hospital, Cairo, Egypt. Twenty five-gauge trocar-assisted flanged intrascleral sutureless technique was used for IOL fixation, in which retinal microforceps were used to capture and externalize both haptics through a scleral tunnel. CDVA, IOP measurements and IOL centralization were reported pre- and one day, one & 3 months postoperatively. Any intra- or postoperative complications were recorded.

Results

The mean LogMAR CDVA had significantly improved one day, 1 & 3 months postoperatively (0.74 ± 0.1, 0.42 ± 0.07 and 0.26 ± 0.08 respectively, p  < 0.001) compared to the preoperative value (1.7 ± 0.17). The mean IOP showed no significant changes along the follow-up period (16.9 ± 0.1; 16.2 ± 1.1; 16.3 ± 0.9 mmHg, p = 0.68, 0.58, 0.89) respectively at 1st day, 1 & 3 months postoperatively) compared to the preoperative measurement (16.4 ± 1.8 mmHg). The IOL was found to be centralized in all cases. No intra- or postoperative complications were encountered.

Conclusion

25-gauge trocar-assisted flanged intrascleral sutureless IOL fixation is found to be a reliable and effective technique that overcomes Yamane technique's challenges for IOL fixation in cases with posterior capsular insufficiency.
Descemet stripping only and ripasudil for the treatment of traumatic Descemet’s membrane ruptures
Authors: Fernández López Ester , Montolío-Marzo Santiago , Ortega Pérez Carolina , Catalán Gómez Magdalena , Peris Martínez Cristina , Piá Ludeña Jose Vicente , Chan Elsie
Published: April 2022

Purpose

Descemet´s membrane ruptures (with a discontinuation of Descemet´s membrane and double detached coiled edges) in the context of complicated anterior segment surgery have rarely been described and its management can be challenging. We report a modified Descemet stripping only (DSO) technique associated with ripasudil drops to treat these cases when other techniques fail.

Methods

We describe two cases of large Descemet´s membrane detachments associated with Descemet´s ruptures after cataract surgery that did not respond to two SF6 intracameral injections. As the detached Descemet's membrane and coiled edges might have prevented endothelial cell migration, we decided to perform a modified DSO with post-operative ripasudil drops to promote corneal clearance.

Results

Both cases improved significantly in unaided and best corrected visual acuity (BCVA), corneal clearance and pachymetry, avoiding the need for an endothelial keratoplasty. Endothelial cells were observed on specular microscopy within the area of the descemetorhexis.

Conclusion

DSO with ripasudil drops might be a valuable tool to recover corneal clearance and avoid endothelial keratoplasty in complex Descemet´s membrane detachments with ruptures that do not respond to other treatments.
Closed intravenous systems for central vascular access: A difference maker for CLABSI rates in neonates?
Authors: van Rens Matheus F.P.T. , Hugill Kevin , Francia Airene L.V. , Mahmah Mohamad Adnan , Al Shadad Afaf Boulous J , Chiuco Imelda Caseres , Garcia Krisha L.P.
Published: April 2022

Background:

Infants in neonatal units are susceptible to numerous potential iatrogenic risks. One key concern is central line-associated blood stream infection (CLABSI). To ensure patient safety and reduce the incidence of CLABSI toward zero, numerous evidence-based clinical interventions and product innovations have been implemented. Nevertheless, sustaining zero CLABSI for sustained periods remains challenging.

Aim:

The purpose of this study was to evaluate the impact on CLABSI rates of introducing a preassembled closed intravenous (IV) administration set in a neonatal intensive care unit (NICU).

Methods:

This was a retrospective observational analysis of routinely collected anonymized IV therapy infection data in a NICU. The study period was from January 2019 through June 2020.

Results:

Nine-hundred eighty five patients with a Epicutaneo-Caval Catheter (ECC) were included (456 legacy IV set, 529 closed IV set). Patient demographics were comparable between the two groups. ECC dwell time was the only IV characteristic associated ( p = 0.04) with CLABSI. Mann-Whitney U-test demonstrated significant differences between the two sets for CLABSI complication events ( p = 0.031). Prior to using the closed IV administration sets (January 2019–September 2019) the mean monthly CLABSI rate was 2.87 (/1000 device days). This figure declined to 0.22 (/1000 device days) afterwards (October 2019–June 2020). Zero CLABSIs were observed during January to June 2020.

Conclusions:

Utilization of a pre-assembled closed IV administration set was associated with a reduction in CLABSI rates. The study results suggest that using a pre-assembled closed IV set concurrently with evidence-based central line infection control interventions can help attain extended periods of zero CLABSI.
Sea Cucumber Compounds Targeting NF-κB in Cancer Treatment
Authors: Wargasetia Teresa Liliana , Ratnawati Hana , Widodo Nashi
Published: April 2022

Cancer is a major health problem worldwide and the leading cause of death in many countries. It remains challenging to find anticancer treatments that work efficiently for varying types of cancer cells. Several studies revealed that nuclear factor kappa B (NF-κB) is a family of dimeric transcription factors that induce tumor promotion, progression, and therapeutic resistance, providing evidence that NF-kB may be a promising target for cancer drugs. Some research has found that sea cucumber biocompounds have anticancer properties, but further research is essential to confirm anticancer targets. This manuscript discusses the mechanisms of anticancer targeting the NF-κB signaling pathway induced by sea cucumber-derived compounds. Additional database analysis showed the protein targeted by the compounds involved in several pathways related to the NF-κB network. Moreover, SwissADME predicted druglikeliness properties of the active compounds of sea cucumber. The discussion is expected to provide new insight into the promising potential of these marine natural products for the treatment of many different types of cancers.
Patients With Autism Spectrum Disorder and Co-occurring Substance Use Disorder: A Clinical Intervention Study
Authors: Walhout Sharon JN , Zanten Johan van , DeFuentes-Merillas Laura , Sonneborn Christina KME , Bosma Marc
Published: April 2022

Background:

The prevalence of substance use disorders (SUD) in individuals with autism spectrum disorders (ASD) appears to be higher than previously described. Attention has been drawn to developing new treatment approaches for this patient population, as they appear to do less well with traditional addiction treatment. There is very little research addressing treatment outcome. This study aims to introduce and evaluate a manualized group treatment intervention developed specifically for patients with ASD and co-occurring SUD.

Methods:

We developed a group treatment based on cognitive behavioural therapy (CBT) and evaluated outcome measures at the end of treatment and 3-month follow-up. Fifty-seven patients with ASD and co-occurring SUD were included of which 30 completed the group intervention, 27 of them also participated at 3-month follow-up.

Results:

The findings suggest that group treatment can work for patients with ASD and co-occurring SUD. Lower levels of alcohol use ( t = 3.61, P = .002, d = 0.75), craving ( t = 2.65, P = .013, d = 0.51), passive coping styles ( t = 2.32, P = .030, d = 0.48), depression ( t = 3.48, P = .002, d = 0.67), anxiety ( t = 3.02, P = .006, d = 0.58), and stress ( t = 2.62, P = .015, d = 0.51) symptoms were reported after completing the group intervention, with even stronger effects at 3 months follow-up.

Conclusions:

The present study shows promising results of a tailor-made group intervention in a heterogeneous patient population with ASD and co-occurring SUD with positive effects on both symptoms of ASD and SUD.
Seasonal Variability Influence on the Prevalence of Diarrhoea among Under-Five-Year-old Children in Kersa District, Eastern Ethiopia: A Community-Based Longitudinal Study
Authors: Mengistie Bezatu , Gobena Tesfaye , Admassu Desalegn , Assefa Nega , Mekbib Ayele Dinku , Mengistu Dechasa Adare , Worku Alemayehu , Kumie Abera , Terfa Waltaji , Bikila Zerihun , Azage Muluken
Published: April 2022

Background:

The health effects of climate change have been found to be a global concern for the last 2 centuries. However, the effect of climate variability on diarrhoea among under-five-year-old children is perhaps undocumented or otherwise unknown. The aim of the present study was to determine the effect of climate variability on diarrhoea among children under 5 years of age.

Methods:

A community-based longitudinal study was conducted over 8 repeated visits from June 2016 to May 2018 at the Kersa Demographic Surveillance and Health Research Center. A total of 500 randomly selected households and their 48 improved water sources were included in the survey from 3 agro-ecological zones, the rural and urban areas of the study area. Data was collected on household characteristics, diarrhoea, WASH practices, water quality and quantity in households, and improved water sources. A structured pre-tested questionnaire, an observational check list and laboratory tests were used for data collection. The data was entered into Epi Data Version 3.01 and transferred to Stata Version 12 for analysis. Multilevel mixed-effect Poisson regression was used to determine the relationship between predictors and outcome variables. A P-value of less than .05 was the cut-off point for statistically significant.

Results:

The prevalence of diarrhoea in 2 weeks among children under 5 years of age was 17.2% (95% CI: 15.8-19.71). Rainfall, E. coli contamination of drinking water at the source and in the home, 20 L of water consumption per capita per day, sharing water sources with animals and home water treatment by residents of the mid- and lowlands were all predictors of diarrhoea. The space-time scan statistic confirmed that child diarrhoea had random variation in both space and time.

Conclusion:

Climate variability has influenced the prevalence of diarrhoea among under-five-year-old children. Climate-resilient measures should be taken to reduce the burden of diarrhoea in the community.
A Look at COVID-19 Global Health Situation, 1-Year Post Declaration of the Pandemic
Authors: Sanyaolu Adekunle , Marinkovic Aleksandra , Prakash Stephanie , Abbasi Abu Fahad , Patidar Risha , Williams Martina , Zhao Anne , Dzando Gideon , Okorie Chuku , Izurieta Ricardo
Published: April 2022

The new coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was declared a pandemic on 11 March 2020 by the World Health Organization (WHO). The impacts of COVID-19 have changed over the past year globally. There were 116 million confirmed cases of COVID-19 in more than 220 countries, including 2.5 million deaths, as reported at the end of the first week of March 2021. Throughout this time, different variants of SARS-CoV-2 have emerged. In early March, the United States of America (USA) led in both confirmed cases and casualties, while India followed in the number of confirmed cases and Brazil in the number of deaths. Vaccines are available in the USA and worldwide to help combat COVID-19. The level of preparedness among multisectoral communities played a role in transmission rates; therefore, lessons learned from past outbreaks, alongside this pandemic, are crucial in establishing policies and regulations to reduce and/or prevent the spread. This narrative literature review provides an update on the global spread of the COVID-19 outbreak, and the current impact of the pandemic 1-year after the declaration, preparedness, and mitigation efforts since the outbreak.
The Greek translation and validation of the electronic version of the Meno-D rating scale for post-menopausal depression
Authors: Papazisis Georgios , Tsakiridis Ιoannis , Apostolopoulou Aikaterini , Papaefstathiou Efstathios , Bellali Thalia , Liozidou Athanasia , Pappa Athanasia , Ainatzoglou Alexandra , Tzitiridou Maria , Billis Antonis , Dagklis Themistoklis
Published: April 2022

Menopausal transition and post-menopause constitute windows of increased vulnerability to depression. Recently, the Meno-D was introduced, a novel 12-item, with five distinct subscales. The aim of our study was to translate and validate the electronic version of the Meno-D among Greek post-menopausal women. Translation and back-translation were performed by an expert group, while face validity was assessed by five experts. Along with the Beck Depression Inventory-II, the Meno-D scale was distributed online to 502 post-menopausal women. A confirmatory factor analysis was performed to investigate construct validity and both convergent and discriminant validity were evaluated. The data analysis was performed using Statistical Package for Social Sciences and AMOS. The 5-factor model of Meno-D achieved adequate levels of goodness-of-fit indices, scoring lower values in discriminant validity examined with heterotrait-monotrait ratio and composite reliability. The significant correlation with the Beck Depression Inventory-ΙΙ revealed for all subscales was indicative of good convergent validity. An exploratory factor analysis was additionally performed, suggesting a 12-item tool comprising two subscales: (i) psychological and (ii) biological and achieving good levels of fit. Our data confirmed that the electronic version of Meno-D is a valid tool that can be used for screening and evaluation of depression in Greek post-menopausal women.
Monstrous awakenings: Queer Necropolitics in Vivek Shraya and Ness Lee's Death Threat
Authors: Da Costa Jade Crimson Rose
Published: April 2022

The study of Queer Necropolitics has established that white futurity regularly relegates trans women of colour to zones of death and sacrifice. What has received less attention, however, is how trans women of colour use art to challenge these murderous assemblages. A primary example of this is Shraya and Lee's (2019) graphic novel Death Threat, which re-envisions a series of transmisogynistic hate letters that Shraya received in 2017. Taking Death Threat as my point of entry, I ask how trans women of colour can repair death into live-affirming art, giving substantive focus to the text's tendency to conflate the literal death of the body with the ‘social death’ of being misgendered. From here, I explore how Death Threat transforms the death worlds of trans women of colour into sites of agency and, in so doing, troubles and expands the analytical boundaries of Queer Necropolitics.