Digital Commons Network^™

Slowing Down Accelerated Approval: Examining The Role Of Industry Influence, Patient Advocacy Organizations, And Political Pressure On Fda Drug Approval, Stephanie Diu

Fordham Law Review

The U.S. Food and Drug Administration (FDA) has been revered as the gold standard in pharmaceutical safety and efficacy review since the 1960s. More recently, partly in response to the HIV/AIDS epidemic and the pressing need for new treatments, the FDA established an accelerated approval process to hasten the review of new drug applications so that drugs could be approved and brought to market as soon as possible. Although accelerated approval has led to the availability of new treatments for patients with few other options, this Note argues that, today, the FDA grants accelerated approval too hastily and may be …

The Tin Man Needs A Heart: A Proposed Framework For The Regulation Of Bioprinted Organs, Linda Foit

Fordham Law Review

Each day, seventeen people die in the United States while waiting for an organ transplant. At least part of this need could be met by bioprinting, a technology that allows the on-demand production of custom-sized organs from a patient’s own cells. The field of bioprinting is progressing rapidly: the first bioprinted organs have already entered the clinic. Yet, developers of bioprinted organs face significant uncertainty as to how their potentially lifesaving products will be regulated—and by which government agency. Such regulatory uncertainty has the potential to decrease investment and stifle innovation in this promising technological field. This Note examines how …

A Pilot Sequential Multiple Assignment Randomized Trial (Smart) Protocol For Developing An Adaptive Coaching Intervention Around A Mobile Application For Athletes To Improve Carbohydrate Periodization Behavior, Xiaoxi Yan, David M. Dunne, Samuel G. Impey, Brian Cunniffe, Carmen E. Lefevre, Rodrigo Mazorra, James P. Morton, David Tod, Graeme L. Close, Rebecca Murphy, Bibhas Chakraborty

Research outputs 2022 to 2026

Background: It has recently been identified that manipulating carbohydrate availability around exercise activity can enhance training-induced metabolic adaptations. Despite this approach being accepted in the athletic populations, athletes do not systematically follow the guidelines. Digital environments appear to allow nutritionists to deliver this intervention at scale, reducing expensive human coaching time. Yet, digitally delivered dietary behavior change interventions for athletes and the coaching strategy to support them are still novel concepts within sports nutrition. Methods/design: We aim to recruit 900 athletes across the UK. 500 athletes will be recruited to test the feasibility of a novel menu planner mobile application …

Prognostic And Predictive Value Of Β-Blockers In The Eortc 1325/Keynote-054 Phase Iii Trial Of Pembrolizumab Versus Placebo In Resected High-Risk Stage Iii Melanoma, Oliver J. Kennedy, Michal Kicinski, Sara Valpione, Sara Gandini, Stefan Suciu, Christian U. Blank, Georgina V. Long, Victoria G. Atkinson, Stéphane Dalle, Andrew M. Haydon, Andrey Meshcheryakov, Adnan Khattak, Matteo S. Carlino, Shahneen Sandhu, James Larkin, Susana Puig, Paolo A. Ascierto, Piotr Rutkowski, Dirk Schadendorf, Rutger Koornstra, Leonel Hernandez-Aya, Anna M. Di Giacomo, Alfonsus J.M. Van Den Eertwegh, Jean Jacques Grob, Ralf Gutzmer, Rahima Jamal, Alexander C.J. Van Akkooi, Caroline Robert, Alexander M. M. Eggermont, Paul Lorigan, Mario Mandala

Research outputs 2022 to 2026

Background:

β-adrenergic receptors are upregulated in melanoma cells and contribute to an immunosuppressive, pro-tumorigenic microenvironment. This study investigated the prognostic and predictive value of β-adrenoreceptor blockade by β-blockers in the EORTC1325/KEYNOTE-054 randomised controlled trial.

Methods:

Patients with resected stage IIIA, IIIB or IIIC melanoma and regional lymphadenectomy received 200 mg of adjuvant pembrolizumab (n = 514) or placebo (n = 505) every three weeks for one year or until recurrence or unacceptable toxicity. At a median follow-up of 3 years, pembrolizumab prolonged recurrence-free survival (RFS) compared to placebo (hazard ratio (HR) 0.56, 95% confidence interval (CI) 0.47–0.68). β-blocker use was …

Causal Associations Between Covid-19 And Atrial Fibrillation: A Bidirectional Mendelian Randomization Study, Xiaoyu Zhang, Biyan Wang, Tao Geng, Di Liu, Qiuyue Tian, Xiaoni Meng, Qiaoyun Zhang, Mengyang Jiang, Yiqiang Zhang, Manshu Song, Wei Wang, Youxin Wang, Baoguo Wang

Research outputs 2022 to 2026

Background and aims: Observational studies showed that coronavirus disease (2019) (COVID-19) attacks universally and its most menacing progression uniquely endangers the elderly with cardiovascular disease (CVD). The causal association between COVID-19 infection or its severity and susceptibility of atrial fibrillation (AF) remains unknown. Methods and results: The bidirectional causal relationship between COVID-19 (including COVID-19, hospitalized COVID-19 compared with not hospitalized COVID-19, hospitalized COVID-19 compared with the general population, and severe COVID-19) and AF are determined by using two-sample Mendelian randomization (MR) analysis. Genetically predicted severe COVID-19 was not significantly associated with the risk of AF [odds ratio (OR), 1.037; 95% …

Food Supply Impacts And Solutions Associated With The Covid-19 Pandemic: A Regional Australian Case Study, Stephanie Louise Godrich, Flavio Macau, Katherine Kent, Johnny Lo, Amanda Devine

Research outputs 2022 to 2026

This study aimed to explore how food supply chains were impacted by COVID-19 and identify how the region could be better prepared for future crises. An online survey was completed by 107 consumers. In-depth interviews were conducted with 27 food supply stakeholders working in food production, distribution, retail, hospitality, institutions (i.e., childcare), logistics/freight and local government. Pre-COVID-19, farmer-direct distribution options and hospitality businesses comprised a substantial proportion of local food producer businesses. During the COVID-19 pandemic, consumers favoured local food supply options, farmers collaborated, and produce usually destined for export was redirected into local markets. Critical food supply actions included …

Identification And Evaluation Of Tools Utilised For Measuring Food Provision In Childcare Centres And Primary Schools: A Systematic Review, Audrey Elford, Cherice Gwee, Maliney Veal, Rati Jani, Ros Sambell, Shabnam Kashef, Penelope Love

Research outputs 2022 to 2026

Background: Children aged 2–11 years spend significant hours per week in early childhood education and care (ECEC) and primary schools. Whilst considered important environments to influence children’s food intake, there is heterogeneity in the tools utilised to assess food provision in these settings. This systematic review aimed to identify and evaluate tools used to measure food provision in ECEC and primary schools. Methods: The Preferred Reporting Items for Systematic Reviews (PRISMA) was followed. Publications (2003–2020) that implemented, validated, or developed measurement tools to assess food provision within ECEC or primary schools were included. Two reviewers extracted and evaluated studies, cross …

An Assessment Of The Impact Of Corporate Governance Mechanisms And Principles On Corporate Performance: The Case Of The Uae, Carina Schafer

Dissertations

This research is concerned with investigating the effect of selected internal and external corporate governance mechanisms and principles on UAE corporate performance. The UAE started to apply uniform corporate governance standards in 2009 with the introduction of Resolution No. (518) of 2009 concerning Governance Rules and Corporate Discipline by the regulator SCA. Since then, there have been various rules implemented by the regulator in 2016 and 2020. Corporate governance has been in the spotlight of academic research, particularly in the United States and Europe, due to the vital role it plays in the overall health of economic systems. In the …

Application Of Red Cabbage Anthocyanins As Ph-Sensitive Pigments In Smart Food Packaging And Sensors, Reza Abedi-Firoozjah, Shima Yousefi, Mahshid Heydari, Faezeh Seyedfatehi, Shima Jafarzadeh, Reza Mohammadi, Milad Rouhi, Farhad Garavand

Research outputs 2022 to 2026

Anthocyanins are excellent antioxidant/antimicrobial agents as well as pH-sensitive indicators that provide new prospects to foster innovative smart packaging systems due to their ability to improve food shelf life and detect physicochemical and biological changes in packaged food. Compared with anthocyanins from other natural sources, red cabbage anthocyanins (RCAs) are of great interest in food packaging because they represent an acceptable color spectrum over a broad range of pH values. The current review addressed the recent advances in the application of RCAs in smart bio-based food packaging systems and sensors. This review was prepared based on the scientific reports found …

Numerical And Theoretical Investigations Of Fractional Differential Equations, Sara Rafiq Al Fahel

Theses

Fractional calculus has been recently received huge attention from Mathematicians and engineers due to its importance in many real-life applications such as: fluid mechanics, electromagnetic, acoustics, chemistry, biology, physics and material sciences. In this thesis, we present numerical algorithms for solving fractional IVPs and system of fractional IVPs where two types of fractional derivatives are used: Caputo-Fabrizio, and Atangana-Baleanu-Caputo derivatives. These algorithms are developed based on modified Adams-Bashforth method. In addition, we discuss the theoretical solution of special class of fractional IVPs. Several examples are discussed to illustrate the efficiency and accuracy of the present schemes.

Computableviz: Mathematical Operators As A Formalism For Visualization Processing And Analysis, Aoyu Wu, Wai Tong, Haotian Li, Dominik Moritz, Yong Wang, Huamin. Qu

Research Collection School Of Computing and Information Systems

Data visualizations are created and shared on the web at an unprecedented speed, raising new needs and questions for processing and analyzing visualizations after they have been generated and digitized. However, existing formalisms focus on operating on a single visualization instead of multiple visualizations, making it challenging to perform analysis tasks such as sorting and clustering visualizations. Through a systematic analysis of previous work, we abstract visualization-related tasks into mathematical operators such as union and propose a design space of visualization operations. We realize the design by developing ComputableViz, a library that supports operations on multiple visualization specifications. To demonstrate …

Rescuecastr: Exploring Photos And Live Streaming To Support Contextual Awareness In The Wilderness Search And Rescue Command Post, Brennon Jones, Anthony Tang, Carman Neustaedter

Research Collection School Of Computing and Information Systems

Wilderness search and rescue (WSAR) is a command-and-control activity where a Command team manages field teams scattered across a large area looking for a lost person. The challenge is that it can be difficult for Command to maintain awareness of field teams and the conditions of the field. We designed RescueCASTR, an interface that explores the idea of deploying field teams with wearable cameras that stream live video or sequential photos periodically to Command that aid contextual awareness. We ran a remote user study with WSAR managers to understand the opportunities and challenges of such a system. We found that …

Student Nurses' Career Preferences For Working With People With Dementia: A Longitudinal Cohort Study, M Hebditch, S Daley, W Grosvenor, Et Al

Peninsula Medical School

BACKGROUND: Internationally there are too few suitably skilled registered nurses to meet the demands for dementia care. Research has established low preferences in undergraduate nursing students for working with older people. However, there is limited research on preferences for dementia care. Understanding career preferences is one component of ensuring future workforce capacity. OBJECTIVE: To assess student nurses' preferences during undergraduate training in relation to working with people with dementia. METHODS: Data from a longitudinal survey collected at two UK universities were analysed (n = 488). Measures included career preferences, demographics, participation in a dementia educational intervention, and measures of attitude, …

Wealth Accumulation By Hypogamy In Own And Parental Education In China, Cheng Cheng, Yang Zhou

Research Collection School of Social Sciences

Objective: This study examines how household wealth accumulation varies by different types of hypogamy on the basis of couples' own and parental education. Background: Educational hypogamy (wives having more education than their husbands) is increasingly relevant in many societies, given the reversal of the gender gap in education. Prior research has studied how marital sorting on couples' own education shapes their individual earnings trajectories. Few have examined the implications of marital sorting on parental education for family-level economic well-being. Method: Using data from the 2010–2018 China Family Panel Studies and multilevel growth curve models, this study examined how household wealth …

Aestheticized Temples, Rationalized Affects: Sacred Modernities And The Micro-Regulation Of Hinduism In Singapore, Orlando Woods, Lily Kong

Research Collection School of Social Sciences

This paper develops the idea of “sacred modernities” to explore how the state- led regulation of religion shapes religious communities and religious subjects therein. Sacred modernities define the ways in which sacredness is understood and engaged with under conditions of secular modernity, and in particular, how sacredness is experienced within a context of micro-regulated religious space. We illustrate these ideas through an empirical examination of how Singapore’s Hindu community engages with the idea of sacredness in and through the temple. By contrasting the experiences of Singaporean and non-Singaporean Hindus, we argue that Singapore’s temples offer an aestheticized experience of the …

Socializing Targets Of Older Adults’ Sns Use: Social Strain Mediates The Relations Between Older Adults’ Sns Use With Friends And Well-Being Outcomes, Yue Qi Germaine Tng, Hwajin Yang

Research Collection School of Social Sciences

Studies have yielded mixed findings regarding the relation between older adults’ social networking site (SNS) use and well-being. Drawing on socioemotional selectivity theory, we sought to examine whether older adults’ SNS use with different socializing targets (i.e., family vs friends) would differentially predict global, social, and mental well-being outcomes indexed by life satisfaction, loneliness, and depressive symptoms, respectively. Furthermore, we examined whether social support and social strain would mediate, in parallel, the relations between SNS use and well-being outcomes. We recruited healthy, community-dwelling older adults (ages 60–93 years, N = 69). Using the PROCESS macro, we found that SNS use …

Internet Privacy Concerns Revisited: Oversight From Surveillance And Right To Be Forgotten As New Dimensions, Gaurav Bansal, Fiona Fui-Hoon Nah

Research Collection School Of Computing and Information Systems

In the post-Snowden revelation era, concerns related to government surveillance and oversight have come to the forefront. The ability of the Internet to remember “everything” (or forget anything) also raises a privacy concern associated with the right to be forgotten (RTBF). In this paper, we examine the conceptualization of Internet privacy concerns (IPC) by extending Hong and Thong's (2013) model with the addition of two dimensions: oversight (i.e., due to surveillance) and the RTBF. We provide theoretical and empirical evidence for our proposed integrated conceptualization. Data were collected from Amazon's Mechanical Turk and analyzed with structural equation modeling using a …

"You're Already Black...": Racially-Informed Care And Intersections Of Gender For Lgbtq African American Children And Youth In Birmingham, Alabama, Stacie Hatfield

Faculty Publications

No abstract provided.

The Word For Everyone, Rogelio Paquini

Faculty Publications

No abstract provided.

April 2022 News Releases, University Of Montana--Missoula. Office Of University Relations

University of Montana News Releases, 1928, 1956-present

No abstract provided.

Assessing The Effect Of Negative Mood States On Valence-Dependent Belief Updating, Aleksandr Karnick

Master's Theses

Individuals consistently tend to underestimate the likelihood of negative events happening to them and fail to update these beliefs adequately when provided with statistical evidence. However, depressed populations are better able to accurately update beliefs. It is not clear if the ability to update beliefs effectively is due to overall dysphoria or are partially due to momentary fluctuations of acute affective states. Undergraduates (N=83) completed a belief updating task where they estimated the likelihood of a negative event happening to them, were presented with the actual likelihood of the event, and then re-estimated the likelihood of the event happening to …

Emotions In Work And War: Comparisons Of Emotional-Cultures Of New Deal Ccc Enrollees And Wwii U.S. Army Enlistees, 1933-1945, Maeve Losen

Master's Theses

Though the Great Depression and Second World War were consecutive eras and overlapped in numerous aspects, scholarship often overlooks the commonalities between these periods. To demonstrate these eras’ shared qualities, this thesis examines the relationship in emotional-cultures—the cultural norms that dictated how individuals felt and demonstrated their emotions—among Civilian Conservation Corps (CCC) enrollees and U.S. Army enlistees during WWII.

The broad intent of this undertaking is to place the cultural history of the Great Depression and WWII in conversation and to show the advantage of inter- and multidisciplinary work by applying anthropological and historical theories of emotion. Though the historical …

Oxygen Targets During Mechanical Ventilation In The Icu: A Systematic Review And Meta-Analysis, Andrew F. Cumpstey, Alex H. Oldman, Daniel S. Martin, Andrew Smith, Michael P.W. Grocott

Peninsula Medical School

OBJECTIVES: Patients admitted to intensive care often require treatment with invasive mechanical ventilation and high concentrations of oxygen. Mechanical ventilation can cause acute lung injury that may be exacerbated by oxygen therapy. Uncertainty remains about which oxygen therapy targets result in the best clinical outcomes for these patients. This review aims to determine whether higher or lower oxygenation targets are beneficial for mechanically ventilated adult patients.DATA SOURCES: Excerpta Medica dataBASE, Medical Literature Analysis and Retrieval System Online, and Cochrane medical databases were searched from inception through to February 28, 2021.STUDY SELECTION: Randomized controlled trials comparing higher and lower oxygen targets …

Authenticated Key Establishment Protocol For Constrained Smart Healthcare Systems Based On Physical Unclonable Function, Abdalla Saleh Elkushli

Theses

Smart healthcare systems are one of the critical applications of the internet of things. They benefit many categories of the population and provide significant improvement to healthcare services. Smart healthcare systems are also susceptible to many threats and exploits because they run without supervision for long periods of time and communicate via open channels. Moreover, in many implementations, healthcare sensor nodes are implanted or miniaturized and are resource-constrained. The potential risks on patients/individuals’ life from the threats necessitate that securing the connections in these systems is of utmost importance. This thesis provides a solution to secure end-to-end communications in such …

Mineral Nutritional Status Of Plants Of A Public Park Under Long-Term Irrigation With Treated Sewage Effluent, Chandana Chakraborty

Theses

Treated sewage water is widely used for irrigation of urban greenery in UAE, and it contains significant number of elements that serve as nutrients for plants. The crucial unresolved question that remains, is regarding its long-term impact on the nutritional status of plants. Sulaimi Park of Al Ain was chosen as the study site. The main objective was to examine if the nutrient supply was adequate for plants. N, P, K levels were expected to exceed plant demands and micronutrient supply was assumed to be below plant requirements. To assess this, soil pH, annual nutrients input with water and elemental …

Uae Kindergarten Teachers’ Mathematical Beliefs And Self-Reported Practices, Mausmi Dilip Jadhav

Theses

Research stresses that young children must be nurtured and encouraged to develop cognitive processes of higher order thinking skills from a young age in order to excel in later years. According to the joint position statement issued by the National Association for the Education of Young Children and the National Council of Teachers of Mathematics (2010), which was endorsed by the Ministry of Education, UAE, all kindergarten teachers should practice developmentally appropriate mathematics instruction to promote mathematical thinking. However, there is a paucity of research that reflects the beliefs and confidence of the UAE kindergarten teachers in facilitating developmentally appropriate …

Exploring Cycle 2 English Teachers’ Beliefs Toward Assessment Practices In The United Arab Emirates, Othaiba Salem Al Dhaheri

Theses

The new language assessment policies in the UAE necessitate that English language teacher need to be cognizant about the new language assessment. The inseparable connection between learning and teaching is at the center of assessment today. This study tries to explore cycle 2 English language teachers’ beliefs toward their assessment practices in the UAE. The study seeks to understand teachers’ assessment practices, beliefs, and obstacles through two means: a semi-structured interview followed by a self-report questionnaire. The study employs an exploratory sequential mixed method design. In the first phase, a semi-structured interview is conducted with 6 cycle 2 English language …

Effect Of Natural Elicitors And Cold Storageperiod On Quality Improvement Of Uae Date Palm Fruit (Phoenix Dactylifera L. Cv. Khesab), Shamsa Salem Nasser Abdulla Alblooshi

Theses

Date palm (Phoenix dactylifera L.) is one of the most important fruit trees grown in arid and semi-arid regions. Despite the immense capabilities of date palm, it is still a challenge to maintain fruit quality, marketability, and shelf life. The objective of this study was to investigate the synergistic effect of a preharvest spray application of the natural elicitor chitosan (Ch) 1% alone and in combination with salicylic acid (SA) 2 mM and calcium chloride (Ca) 3%; (Ch, SA, Ca, Ch+Ca, Ch+ SA, Ch+ SA +Ca) on the quality parameters, shelf life and bioactive compound content of date fruit of …

Assessment Of Natural Hazards Impact On Heritage Sites In The United Arab Emirates (Uae) Using Geographic Information System (Gis), Abdulla Salem Ahmed Saeed Alyammahi

Theses

The United Arab Emirates (UAE) pays significant attention to preserving its heritage sites and archaeological finds and treats them as a vital part of its culture, history, and economy. In recent years, the field of archaeology in the UAE has witnessed tangible and significant developments, with many government initiatives being devoted to establishing archaeological departments in all emirates. The firmly stated policy of these institutions is to preserve the UAE heritage sites and educate the public about their importance. However, these sites are vulnerable to natural hazards, considered one of the most critical threats to the UAE heritage sites. In …

Investigating The Role Of Fun30, A Chromatin Remodeler, In Dna Repair, Mehwish Iqbal

Dissertations

The repair of DNA double-strand breaks (DSBs) is crucial for maintaining genome stability. DSB repair needs to take place within the complex organization of the chromatin, and this requires changes in the chromatin structure adjacent to DSB sites. These changes occur through covalent histone modifications that alter histone-DNA contacts as well as by the action of ATP-dependent chromatin remodelers. Many chromatin remodelers, including Fun30, are involved in DSB repair. Fun30 facilitates DNA end resection at DSB site during the homologous recombination repair pathway. Apart from its role in DNA repair, Fun30 promotes gene silencing at heterochromatic loci such as telomeres, …