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Regulatory science

Feng Shen, Qing Guo, Qi Hu, Ailiang Zeng, Weining Wu, Wei Yan, Yongping You
Nuclear factor κB (NF-κB) exhibits an important role in inflammation and tumorigenesis. The key regulatory protein of the pathway, RELB Proto-Oncogene, NF-KB Subunit (relB), is overexpressed and associated with the pathogenesis of a variety of malignant tumors. However, the molecular features and clinical signature of relB expression in gliomas remains to be elucidated. The present study obtained the raw sequencing data of 325 glioma samples of all grades from the Chinese Glioma Genome Atlas (CGGA) database and human glioma cell line (LN229) from the Chinese Academy of Sciences cell bank...
April 2018: Oncology Letters
Guangyong Zheng, Tao Huang
In post-genomic era, an important task is to explore the function of individual biological molecules (i.e., gene, noncoding RNA, protein, metabolite) and their organization in living cells. For this end, gene regulatory networks (GRNs) are constructed to show relationship between biological molecules, in which the vertices of network denote biological molecules and the edges of network present connection between nodes (Strogatz, Nature 410:268-276, 2001; Bray, Science 301:1864-1865, 2003). Biologists can understand not only the function of biological molecules but also the organization of components of living cells through interpreting the GRNs, since a gene regulatory network is a comprehensively physiological map of living cells and reflects influence of genetic and epigenetic factors (Strogatz, Nature 410:268-276, 2001; Bray, Science 301:1864-1865, 2003)...
2018: Methods in Molecular Biology
Takudzwa J Mtisi, Charles Maponga, Tsitsi G Monera-Penduka, Tinashe Mudzviti, Dexter Chagwena, Faithful Makita-Chingombe, Robin DiFranchesco, Gene D Morse
Background: A growing number of drug development studies that include pharmacokinetic evaluations are conducted in regions lacking a specialised pharmacology laboratory. This necessitated the development of an International Pharmacology Specialty Laboratory (IPSL) in Zimbabwe. Objectives: The aim of this article is to describe the development of an IPSL in Zimbabwe. Methods: The IPSL was developed collaboratively by the University of Zimbabwe and the University at Buffalo Center for Integrated Global Biomedical Sciences...
2018: African Journal of Laboratory Medicine
Luca Mazzarella, Alessandro Guida, Giuseppe Curigliano
Epidermal Growth Factor Receptor (EGFR)-dependent signaling plays a crucial role in epithelial cancer biology, and dictated the development of several targeting agents. The mouse-human chimeric antibody Cetuximab was among the first to be developed. After about two decades of clinical research it has gained a significant place in the management of advanced colorectal and head and neck cancers, whereas its development in non small cell lung cancer (NSCLC) has not led to a place in routine clinical practice, because of marginal clinical benefit despite statistically significant Phase III trials...
March 14, 2018: Expert Opinion on Biological Therapy
Russell S Thomas, Richard S Paules, Anton Simeonov, Suzanne C Fitzpatrick, Kevin M Crofton, Warren M Casey, Donna L Mendrick
The traditional approaches to toxicity testing have posed multiple challenges for evaluating the safety of commercial chemicals, pesticides, food additives/contaminants, and medical products.The challenges include number of chemicals that need to be tested, time and resource intensive nature of traditional toxicity tests, and unexpected adverse effects that occur in pharmaceutical clinical trials despite the extensive toxicological testing.Over a decade ago, the U.S. Environmental Protection Agency (EPA), National Toxicology Program (NTP), National Center for Advancing Translational Sciences (NCATS), and the Food and Drug Administration (FDA) formed a federal consortium for "Toxicology in the 21st Century" (Tox21) with a focus on developing and evaluating in vitro high-throughput screening (HTS) methods for hazard identification and providing mechanistic insights...
March 8, 2018: ALTEX
Ludwig E Feinendegen, Jerry M Cuttler
There is considerable controversy regarding risk of health detriment after low-level exposure to ionizing radiation. This stems in part from a sort of distance between radiation biologists, epidemiologists, and radiation protection professionals, as well as regulatory institutions. Also, there is a lack of overview of the relevant data and their origins regarding health risks at low doses of ionizing radiation. This seriously into a somewhat hazy fear of ionizing radiation that besets large portions of the public...
March 8, 2018: Health Physics
George A Bray, William E Heisel, Ashkan Afshin, Michael D Jensen, William H Dietz, Michael Long, Robert F Kushner, Stephen R Daniels, Thomas A Wadden, Adam G Tsai, Frank B Hu, John M Jakicic, Donna H Ryan, Bruce M Wolfe, Thomas H Inge
The prevalence of obesity, measured by body mass index, has risen to unacceptable levels in both men and women in the United States and worldwide with resultant hazardous health implications. Genetic, environmental, and behavioral factors influence the development of obesity, and both the general public and health professionals stigmatize those who suffer from the disease. Obesity is associated with and contributes to a shortened life span, type 2 diabetes mellitus, cardiovascular disease, some cancers, kidney disease, obstructive sleep apnea, gout, osteoarthritis, and hepatobiliary disease, among others...
March 6, 2018: Endocrine Reviews
Douglas S Mennin, David M Fresco, Mia Skytte O'Toole, Richard G Heimberg
OBJECTIVE: Generalized anxiety disorder (GAD) and major depression (MDD), especially when they co-occur, are associated with suboptimal treatment response. One common feature of these disorders is negative self-referential processing (NSRP; i.e., worry, rumination), which worsens treatment outcome. Emotion Regulation Therapy (ERT) integrates principles from affect science with traditional and contemporary cognitive-behavioral treatments to identify and modify the functional nature of NSRP by targeting motivational and regulatory mechanisms, as well as behavioral consequences...
March 2018: Journal of Consulting and Clinical Psychology
Mark van Kleunen, Franz Essl, Jan Pergl, Giuseppe Brundu, Marta Carboni, Stefan Dullinger, Regan Early, Pablo González-Moreno, Quentin J Groom, Philip E Hulme, Christoph Kueffer, Ingolf Kühn, Cristina Máguas, Noëlie Maurel, Ana Novoa, Madalin Parepa, Petr Pyšek, Hanno Seebens, Rob Tanner, Julia Touza, Laura Verbrugge, Ewald Weber, Wayne Dawson, Holger Kreft, Patrick Weigelt, Marten Winter, Günther Klonner, Matthew V Talluto, Katharina Dehnen-Schmutz
The number of alien plants escaping from cultivation into native ecosystems is increasing steadily. We provide an overview of the historical, contemporary and potential future roles of ornamental horticulture in plant invasions. We show that currently at least 75% and 93% of the global naturalised alien flora is grown in domestic and botanical gardens, respectively. Species grown in gardens also have a larger naturalised range than those that are not. After the Middle Ages, particularly in the 18th and 19th centuries, a global trade network in plants emerged...
March 5, 2018: Biological Reviews of the Cambridge Philosophical Society
Blake Murdoch, Amy Zarzeczny, Timothy Caulfield
OBJECTIVE: To identify the frequency and qualitative characteristics of stem cell-related marketing claims made on websites of clinics featuring common types of complementary and alternative medicine practitioners. The involvement of complementary and alternative medicine practitioners in the marketing of stem cell therapies and stem cell-related interventions is understudied. This research explores the extent to which they are involved and collaborate with medical professionals. This knowledge will help with identifying and evaluating potential policy responses to this growing market...
February 28, 2018: BMJ Open
Michiel T O Jonker, Stephan A van der Heijden, Dave Adelman, Jennifer N Apell, Robert M Burgess, Yongju Choi, Loretta A Fernandez, Geanna M Flavetta, Upal Ghosh, Philip M Gschwend, Sarah E Hale, Mehregan Jalalizadeh, Mohammed Khairy, Mark A Lampi, Wenjian Lao, Rainer Lohmann, Michael J Lydy, Keith A Maruya, Samuel A Nutile, Amy M P Oen, Magdalena I Rakowska, Danny Reible, Tatsiana P Rusina, Foppe Smedes, Yanwen Wu
This work presents the results of an international interlaboratory comparison on ex situ passive sampling in sediments. The main objectives were to map the state of the science in passively sampling sediments, identify sources of variability, provide recommendations and practical guidance for standardized passive sampling, and advance the use of passive sampling in regulatory decision making by increasing confidence in the use of the technique. The study was performed by a consortium of 11 laboratories and included experiments with 14 passive sampling formats on 3 sediments for 25 target chemicals (PAHs and PCBs)...
February 28, 2018: Environmental Science & Technology
Martina Penazzato, Linda Lewis, Melynda Watkins, Vineet Prabhu, Fernando Pascual, Martin Auton, Wesley Kreft, Sébastien Morin, Marissa Vicari, Janice Lee, David Jamieson, George K Siberry
INTRODUCTION: Despite the coordinated efforts by several stakeholders to speed up access to HIV treatment for children, development of optimal paediatric formulations still lags 8 to 10 years behind that of adults, due mainly to lack of market incentives and technical complexities in manufacturing. The small and fragmented paediatric market also hinders launch and uptake of new formulations. Moreover, the problems affecting HIV similarly affect other disease areas where development and introduction of optimal paediatric formulations is even slower...
February 2018: Journal of the International AIDS Society
George C Mejicano, Tracy N Bumsted
Oregon Health & Science University School of Medicine launched a completely new undergraduate medical education curriculum in 2014. This initiative dramatically transformed the MD degree program, changing the instructional content taught, the pedagogical methods used by the faculty, and the methods of assessment, and it added new elements such as academic coaching and programmatic entrustment to the program. One of the most exciting and impactful aspects to date of this curricular transformation has been the deliberate implementation of a competency-based framework that incorporates frequent assessment, tracking of student progression using an electronic portfolio, and academic coaching to optimize learning and customize curricular elements for each student...
March 2018: Academic Medicine: Journal of the Association of American Medical Colleges
Harmeet Singh Rehan, Jahnavi Maini, A Ps Hungin
BACKGROUND: Electronic cigarettes (ECIGs) are devices with a heating element which produces aerosol for inhalation. They have been propagated as a healthier alternative to tobacco smoking and a potential device for smoking cessation, despite non-documentation of their long-term adverse health effects. OBJECTIVES: With the glorification of ECIG, its use has increased even among non-tobacco users. This makes it critical to understand and discuss a true picture about safety and utility of ECIGs by reviewing the literature...
February 26, 2018: Current Drug Safety
John D Boice, Elizabeth D Ellis, Ashley P Golden, David J Girardi, Sarah S Cohen, Heidi Chen, Michael T Mumma, Roy E Shore, Richard W Leggett
The purpose of this paper is to present an overview of ongoing work on the Million Worker Study (MWS), highlighting some of the key methods and progress so far as exemplified by the study of workers at the Mallinckrodt Chemical Works (MCW). The MWS began nearly 25 y ago and continues in a stepwise fashion, evaluating one study cohort at a time. It includes workers from U.S. Department of Energy (DOE) Manhattan Project facilities, U.S. Nuclear Regulatory Commission (NRC) regulated nuclear power plants, industrial radiographers, U...
April 2018: Health Physics
Andrea Cipriani, Toshi A Furukawa, Georgia Salanti, Anna Chaimani, Lauren Z Atkinson, Yusuke Ogawa, Stefan Leucht, Henricus G Ruhe, Erick H Turner, Julian P T Higgins, Matthias Egger, Nozomi Takeshima, Yu Hayasaka, Hissei Imai, Kiyomi Shinohara, Aran Tajika, John P A Ioannidis, John R Geddes
BACKGROUND: Major depressive disorder is one of the most common, burdensome, and costly psychiatric disorders worldwide in adults. Pharmacological and non-pharmacological treatments are available; however, because of inadequate resources, antidepressants are used more frequently than psychological interventions. Prescription of these agents should be informed by the best available evidence. Therefore, we aimed to update and expand our previous work to compare and rank antidepressants for the acute treatment of adults with unipolar major depressive disorder...
February 20, 2018: Lancet
Jeremy P Jamieson, Alia J Crum, J Parker Goyer, Marisa E Marotta, Modupe Akinola
The dominant perspective in society is that stress has negative consequences, and not surprisingly, the vast majority of interventions for coping with stress focus on reducing the frequency or severity of stressors. However, the effectiveness of stress attenuation is limited because it is often not possible to avoid stressors, and avoiding or minimizing stress can lead individuals to miss opportunities for performance and growth. Thus, during stressful situations, a more efficacious approach is to optimize stress responses (i...
February 22, 2018: Anxiety, Stress, and Coping
Wendell Wallach, Marc Saner, Gary Marchant
For many innovations, oversight fits nicely within existing governance mechanisms; nevertheless, others pose unique public health, environmental, and ethical challenges. Synthetic artemisinin, for example, has many precursors in laboratory-developed drugs that emulate natural forms of the same drug. The policy challenges posed by synthetic artemisinin do not differ significantly in kind from other laboratory-formulated drugs. Synthetic biofuels and gene drives, however, fit less clearly into existing governance structures...
January 2018: Hastings Center Report
Yen Ting Lin, Peter G Hufton, Esther J Lee, Davit A Potoyan
Pluripotent embryonic stem cells are of paramount importance for biomedical sciences because of their innate ability for self-renewal and differentiation into all major cell lines. The fateful decision to exit or remain in the pluripotent state is regulated by complex genetic regulatory networks. The rapid growth of single-cell sequencing data has greatly stimulated applications of statistical and machine learning methods for inferring topologies of pluripotency regulating genetic networks. The inferred network topologies, however, often only encode Boolean information while remaining silent about the roles of dynamics and molecular stochasticity inherent in gene expression...
February 16, 2018: PLoS Computational Biology
M Ariel Cascio, Eric Racine
Research ethics is often understood by researchers primarily through the regulatory framework reflected in the research ethics review process. This regulatory understanding does not encompass the range of ethical considerations in research, notably those associated with the relational and everyday aspects of human subject research. In order to support researchers in their effort to adopt a broader lens, this paper presents a "person-oriented research ethics" approach. Five practical guideposts of person-oriented research ethics are identified: (1) respect for holistic personhood; (2) acknowledgement of lived world; (3) individualization; (4) focus on researcher-participant relationships; and (5) empowerment in decision-making...
February 16, 2018: Accountability in Research
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