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1. Can we use a mid-infrared fine-ground soil spectral library to predict non-fine-ground spectra?

Author

Yasas Gamagedara, Nuwan K. Wijewardane, Gary Feng, Cathy Seybold, Michael Williams, Mary Love Tagert, and Vitor S. Martins

Subjects
Soil, Mid-infrared spectroscopy, Calibration transfer, Pre-processing, Science
Abstract

Mid-infrared (MIR) reflectance spectroscopy is a promising and rapid technology to accurately infer soil properties from a single scan. Fine-grinding is an expensive and time-consuming sample processing step in soil MIR spectroscopy that can have a major impact on spectral features and subsequent multivariate model calibrations. The use of existing fine-ground spectral libraries to predict soil properties of new samples (without fine-grinding) can reduce the cost and time in soil analysis. Calibration transfer studies between different grinding states of soil samples (using existing fine-ground spectral libraries to predict non-fine-ground spectra) are not available to the best of our knowledge. To address this research gap, this study investigated different calibration transfer and pre-processing techniques to link the MIR fine-ground spectral models and non-fine-ground soil spectra. Four calibration transfer techniques (direct standardization, external parameter orthogonalization, slope/bias correction, and spiking with extra weight) and four pre-processing techniques (first derivative, detrending, multiplicative signal correction, and standard normal variate) were investigated in this study. The United States Department of Agriculture National Soil Survey Center Kellogg Soil Survey Laboratory’s MIR spectral library (n > 72,000) and a randomly selected subset from the library (n = 519) were used as spectral datasets. Spiking (with extra weight) calibration transfer technique performed well for pH, clay, and sand when using the library (mean R2 = 0.70) and for organic carbon, cation exchange capacity, pH, clay, and sand when using the subset from the library (mean R2 = 0.66). Standard normal variate pre-processing technique performed well with organic carbon, cation exchange capacity, and sand when using the library (mean R2 = 0.67). Overall, spiking (with extra weight) enables the use of existing MIR fine-ground soil spectral libraries to predict those soil properties of new samples without fine-grinding, saving the cost and time.

Published
2024
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2. Cognitive interviewing as a method to inform questionnaire design and validity - Immersive Technology Evaluation Measure (ITEM) for healthcare education

Author

Chris Jacobs, Joshua Wheeler, Michael Williams, and Richard Joiner

Subjects
Education (General), L7-991, Information technology, T58.5-58.64
Abstract

Research of immersive technology in education is rapidly expanding with potential to educate future students in healthcare disciplines. Despite increasing literature there is a lack of validated instruments to investigate the effects of these technologies. Cognitive interviewing is a valuable evaluation method to check comprehension of a measure and was applied to a new measure of user experience of immersive technology for healthcare education (ITEM). A 5 domain self-reported measure of: immersion, intrinsic motivation, cognitive load, system usability, and debrief. Prior to the interview 9 participants were allocated to augmented reality and virtual reality educational activities. Verbal probing and think aloud techniques through semi-structured cognitive interviews were conducted. The ITEM was found to have high content validity index scores and relationships between domains were further explored through qualitative analysis. The results indicate high clarity of understanding for those completing the ITEM and supports future research as part of an ongoing validation process.

Published
2023
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3. Infrarenal aortic dissection in a child after blunt trauma

Author

Michelle Mangold, DO, Jose Mauro Chaves, MD, PhD, Christopher Blewett, MD, and Michael Williams, MD

Subjects
Aortic dissection, Bucket handle bowel injury, Chance fracture, Pediatric, Seat-belt, Trauma, Surgery, RD1-811, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

We present a 4-year-old who suffered blunt abdominal trauma leading to Chance fractures to the lumbar spine, bucket-handle injuries to the ileum and descending colon, and an aortic intimal injury leading to occlusion of the infrarenal aorta with extension to the bifurcation. Her vascular injuries were managed by endarterectomy of the intimal injury, thrombectomy of the distal aorta and bilateral iliac arteries using a Fogarty catheter, and patch angioplasty of the infrarenal aorta using bovine pericardium secured by a combination of interrupted and running sutures to optimize elasticity and operative time.

Published
2022
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4. A systematic review of non-procedural contributors to quality of life in heart valve disease

Author

Ariel Pons, Gillian Whalley, Katherine Sneddon, Michael Williams, and Sean Coffey

Subjects
Quality of life, Heart valve disease, Medicine
Abstract

Background: Quality of life (QOL) is an important outcome in patients with heart valve disease, in cohorts that have received a valve replacement as well as those that have not. Existing reviews on this topic, however, focus primarily on the effect of valve intervention. This systematic review was conducted to provide an overview of non-procedural predictors of QOL in multiple forms of heart valve disease. Measures of QOL can compare outcomes between populations (‘generic’ measures) or within a specific disease state or population (‘specific’). Methods: Pubmed was searched in July 2021 for papers reporting associations of non-procedural factors with QOL. Results: 14 papers with 8433 participants in total were included in the final selection, most of which were aortic valve intervention cohorts. Studies using both generic and specific measures of QOL were included. Sex and body mass index had minimal association with QOL in HVD, while ejection fraction displayed no association. In longitudinal studies, more severe cardiac symptoms before valve intervention were associated with worse QOL after valve intervention. Conclusion: There is limited information on non-procedural contributions to QOL in patients with heart valve disease. Sex, BMI, age, and ejection fraction appear to have little effect. The association of worse long term QOL post-intervention in those with worse pre-intervention symptoms raises the possibility that earlier intervention may be beneficial. Variability of results in different cohorts and between measures of quality of life indicate the need for a disease-specific measure of QOL in heart valve disease.

Published
2022
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5. Predictors of quality of life after revascularization for ischemic heart disease: A systematic review

Author

Ariel Pons, Gillian Whalley, Katherine Sneddon, Michael Williams, and Sean Coffey

Subjects
Quality of life, Myocardial revascularization, Smoking cessation, Hypertension, Medicine
Abstract

Background: Quality of life is a key outcome after coronary revascularization for ischemic heart disease in the modern era. 6–12 months after coronary revascularization, recovery from the intervention itself, especially coronary artery bypass grafting, is no longer the key determinant of quality of life, while the benefits (or lack thereof) of revascularization become more apparent. Potential determinants of quality of life that are not directly related to the form of intervention have been less frequently examined in this group of patients. Methods: This systematic review examined the association of published contributors to quality of life in patients following coronary revascularization for ischemic heart disease 6–12 months post intervention. Studies that reported such associations were identified and assessed for quality. 11 were included in this review. Quality of life was measured by the Short Forms 36 and 12, and the Seattle Angina Questionnaire. Results: Of potentially modifiable factors, current smoking and hypertension displayed the most consistent associations with reduced quality of life after intervention. Quality of life was positively associated with baseline quality of life and being partnered/married, and negatively associated with female sex, diabetes, and lung or renal disease, and only minimally associated with ejection fraction. Age and prior myocardial infarction displayed conflicting associations. Conclusion: To improve patient outcomes following coronary revascularization, other potentially modifiable non-procedural factors that affect quality of life could be targeted for more intensive management. Smoking cessation and anti-hypertensive therapies treat the most consistent factors associated with reduced quality of life after revascularization.

Published
2022
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6. The psychosocial impact of losing an eye through traumatic injury and living with prosthetic restoration: A thematic analysis

Author

Joni Keys, Martin Dempster, Jonathan Jackson, Michael Williams, and Sinead Coyle

Subjects
Trauma, Psychological distress, Qualitative, Adults, Appearance, Psychology, BF1-990
Abstract

This study aims to explore the psychosocial factors and challenges affecting the lives of those who wear an ocular prosthesis following a traumatic eye injury. Thematic analysis of semi-structured interviews with eight individuals resulted in five themes: emotional devastation in the aftermath; moving forward; fear of negative social evaluation; keeping it normal - protecting self and close others; and threat of injury & blindness. Enucleation or evisceration of an eye causes significant emotional stress. Despite successful prosthetic restoration, many individuals continue to experience ongoing psychosocial challenges, as a consequence of their experiences of visible difference and visual impairment.

Published
2021
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7. Just the tonic! Legume biorefining for alcohol has the potential to reduce Europe's protein deficit and mitigate climate change

Author

Theophile Lienhardt, Kirsty Black, Sophie Saget, Marcela Porto Costa, David Chadwick, Robert M. Rees, Michael Williams, Charles Spillane, Pietro M. Iannetta, Graeme Walker, and David Styles

Subjects
Environmental sciences, GE1-350
Abstract

Industrialised agriculture is heavily reliant upon synthetic nitrogen fertilisers and imported protein feeds, posing environmental and food security challenges. Increasing the cultivation of leguminous crops that biologically fix nitrogen and provide high protein feed and food could help to address these challenges. We report on the innovative use of an important leguminous crop, pea (Pisum sativum L.), as a source of starch for alcohol (gin) production, yielding protein-rich animal feed as a co-product. We undertook life cycle assessment (LCA) to compare the environmental footprint of 1 L of packaged gin produced from either 1.43 kg of wheat grain or 2.42 kg of peas via fermentation and distillation into neutral spirit. Allocated environmental footprints for pea-gin were smaller than for wheat-gin across 12 of 14 environmental impact categories considered. Global warming, resource depletion, human toxicity, acidification and terrestrial eutrophication footprints were, respectively, 12%, 15%, 15%, 48% and 68% smaller, but direct land occupation was 112% greater, for pea-gin versus wheat-gin. Expansion of LCA boundaries indicated that co-products arising from the production of 1 L of wheat- or pea-gin could substitute up to 0.33 or 0.66 kg soybean animal feed, respectively, mitigating considerable greenhouse gas emissions associated with land clearing, cultivation, processing and transport of such feed. For pea-gin, this mitigation effect exceeds emissions from gin production and packaging, so that each L of bottled pea gin avoids 2.2 kg CO2 eq. There is great potential to scale the use of legume starches in production of alcoholic beverages and biofuels, reducing dependence on Latin American soybean associated with deforestation and offering considerable global mitigation potential in terms of climate change and nutrient leakage — estimated at circa 439 Tg CO2 eq. and 8.45 Tg N eq. annually. Keywords: Pea, Legumes, Life cycle assessment, LCA, Animal feed, DDGS, Distillation, Ethanol

Published
2019
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8. Data for life cycle assessment of legume biorefining for alcohol

Author

Theophile Lienhardt, Kirsty Black, Sophie Saget, Marcela Porto Costa, David Chadwick, Robert Rees, Michael Williams, Charles Spillane, Pietro Iannetta, Graeme Walker, and David Styles

Subjects
Computer applications to medicine. Medical informatics, R858-859.7, Science (General), Q1-390
Abstract

Benchmarking the environmental sustainability of alcohol produced from legume starch against alcohol produced from cereal grains requires considering of crop production, nutrient cycling and use of protein-rich co-products via life cycle assessment. This article describes the mass balance flows behind the life cycle inventories for gin produced from wheat and peas (Pisum sativum L.) in an associated article summarising the environmental footprints of wheat- and pea-gin [1], and also presents detailed supplementary results. Activity data were collected from interviews with actors along the entire gin value chain including a distillery manager and ingredient and packaging suppliers. Important fertiliser and animal-feed substitution effects of co-product use were derived using detailed information and models on nutrient flows and animal feed composition, along with linear optimisation modelling. Secondary data on environmental burdens of specific materials and processes were obtained from the Ecoinvent v3.4 life cycle assessment database. This article provides a basis for further quantitative evaluation of the environmental sustainability of legume-alcohol value chains. Keywords: Pea, Legumes, Life cycle assessment, LCA, Animal feed, DDGS, Distillation, Ethanol

Published
2019
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9. Evaluating habitat selection of François’ langur in the karst mountains of China: Implications for conservation strategies

Author

Jialiang Han, Xing Fan, Guy Michael Williams, Qixian Zou, and Bingnan Dong

Subjects
Habitat selection, François’ langur, Karst mountains, Conservation strategies, Ecology, QH540-549.5
Abstract

The François’ langur is an endangered primate species endemic to Asia, found in the karst mountain regions of China and Vietnam. These langurs are distributed across isolated locations, where habitat loss and fragmentation pose significant threats to their survival. The Mayanghe National Nature Reserve (MNNR) is home to the largest population of wild François' langurs in the world, estimated at 500–600 individuals. To understand the habitat selection of François’ langurs in the MNNR, a survey was conducted from September 2017 to August 2019. Using species presence data and environmental variables, we analyzed habitat selection through a resource selection function (RSF). Significant habitat differences were found between distribution and control sites. The best model included slope, distance to river, distance to road, vegetation type, and tree height. The distribution of François’ langur is primarily influenced by its reliance on specific vegetation types, sensitivity to human disturbance, and geographical factors. This study clarifies the ecological requirements of wild François’ langurs by analyzing their habitat selection and highlights the importance of understanding these factors to inform conservation efforts.

Published
2024
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10. Differences in rapid increases in county-level COVID-19 incidence by implementation of statewide closures and mask mandates — United States, June 1–September 30, 2020

Author

Catherine Clodfelter, Michael A. Tynan, Amanda Moreland, Maxim Gakh, Gi Jeong, Christina Vaughan Watson, Gregory Sunshine, Mara Howard-Williams, Sebnem Dugmeoglu, Brandy L. Peterson Maddox, Adebola Popoola, Julia Shelburne, Kelly Fletcher, Sharoda Dasgupta, Regen Weber, Gloria J. Kang, Michael Williams, Ryan Cramer, Siobhan Gilchrist, Alexa Limeres, Amanda Savage Brown, Rachel Silver, Ahmed M. Kassem, Lisa Landsman, Trieste Musial, Dawn Pepin, Tiebin Liu, Carol Y. Rao, Rachel Hulkower, Russell F. McCord, and Charles E. Rose

Subjects
2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Epidemiology, Mitigation strategies, 01 natural sciences, Article, 03 medical and health sciences, symbols.namesake, 0302 clinical medicine, Environmental health, Medicine, Humans, 030212 general & internal medicine, Poisson regression, 0101 mathematics, County level, Estimation, Mask mandates, business.industry, Incidence (epidemiology), Incidence, 010102 general mathematics, State government, Masks, COVID-19, Limiting, United States, Communicable Disease Control, symbols, Closures, business
Abstract

Background and Objective Community mitigation strategies could help reduce COVID-19 incidence, but there are few studies that explore associations nationally and by urbanicity. In a national county-level analysis, we examined the probability of being identified as a county with rapidly increasing COVID-19 incidence (rapid riser identification) during the summer of 2020 by implementation of mitigation policies prior to the summer, overall and by urbanicity. Methods We analyzed county-level data on rapid riser identification during June 1–September 30, 2020 and statewide closures and statewide mask mandates starting March 19 (obtained from state government websites). Poisson regression models with robust standard error estimation were used to examine differences in the probability of rapid riser identification by implementation of mitigation policies (P-value Results Counties in states that closed for 0–59 days were more likely to become a rapid riser county than those that closed for >59 days, particularly in nonmetropolitan areas. The probability of becoming a rapid riser county was 43% lower among counties that had statewide mask mandates at reopening (adjusted prevalence ratio = 0.57; 95% confidence intervals = 0.51–0.63); when stratified by urbanicity, associations were more pronounced in nonmetropolitan areas. Conclusions These results underscore the potential value of community mitigation strategies in limiting the COVID-19 spread, especially in nonmetropolitan areas.

Published
2021

11. Reinforcement learning for facilitating human-robot-interaction in manufacturing

Author

Michael Williams, Maneesh Kumar, Harley Oliff, Ying Liu, and Michael Ryan

Subjects
Flexibility (engineering), 0209 industrial biotechnology, Computer science, media_common.quotation_subject, Context (language use), 02 engineering and technology, computer.software_genre, Industrial and Manufacturing Engineering, Adaptability, Human–robot interaction, Task (project management), Intelligent agent, 020901 industrial engineering & automation, Hardware and Architecture, Control and Systems Engineering, Human–computer interaction, 0202 electrical engineering, electronic engineering, information engineering, Reinforcement learning, Robot, 020201 artificial intelligence & image processing, computer, Software, media_common
Abstract

For many contemporary manufacturing processes, autonomous robotic operators have become ubiquitous. Despite this, the number of human operators within these processes remains high, and as a consequence, the number of interactions between humans and robots has increased in this context. This is a problem, as human beings introduce a source of disturbance and unpredictability into these processes in the form of performance variation. Despite the natural human aptitude for flexibility, their presence remains a source of disturbance within the system and make modelling and optimization of these systems considerably more challenging, and in many cases impossible. Improving the ability of robotic operators to adapt their behaviour to variations in human task performance is, therefore, a significant challenge to be overcome to enable many ideas in the larger intelligent manufacturing paradigm to be realised. This work presents the development of a methodology to effectively model these systems and a reinforcement learning agent capable of autonomous decision-making. This decision-making provides the robotic operators with greater adaptability, by enabling its behaviour to change based on observed information, both of its environment and human colleagues. The work extends theoretical knowledge on how learning methods can be implemented for robotic control, and how the capabilities that they enable may be leveraged to improve the interaction between robots and their human counterparts. The work further presents a novel methodology for the implementation of a reinforcement learning-based intelligent agent which enables a change in behavioural policy in robotic operators in response to performance variation in their human colleagues. The development and evaluation are supported by a generalized simulation model, which is parameterized to enable appropriate variation in human performance. The evaluation demonstrates that the reinforcement agent can effectively learn to make adjustments to its behaviour based on the knowledge extracted from observed information, and balance the task demands to optimise these adjustments.

Published
2020

12. Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial

Author

Christoph Male, Anthonie W A Lensing, Joseph S Palumbo, Riten Kumar, Ildar Nurmeev, Kerry Hege, Damien Bonnet, Philip Connor, Hélène L Hooimeijer, Marcela Torres, Anthony K C Chan, Gili Kenet, Susanne Holzhauer, Amparo Santamaría, Pascal Amedro, Elizabeth Chalmers, Paolo Simioni, Rukhmi V Bhat, Donald L Yee, Olga Lvova, Jan Beyer-Westendorf, Tina T Biss, Ida Martinelli, Paola Saracco, Marjolein Peters, Krisztián Kállay, Cynthia A Gauger, M Patricia Massicotte, Guy Young, Akos F Pap, Madhurima Majumder, William T Smith, Jürgen F Heubach, Scott D Berkowitz, Kirstin Thelen, Dagmar Kubitza, Mark Crowther, Martin H Prins, Paul Monagle, Angelo C. Molinari, Ulrike Nowak Göttl, Juan Chain, Jeremy Robertson, Katharina Thom, Werner Streif, Rudolf Schwarz, Klaus Schmitt, Gernot Grangl, An Van Damme, Philip Maes, Veerle Labarque, Antonio Petrilli, Sandra Loggeto, Estela Azeka, Leonardo Brandao, Doan Le, Christine Sabapathy, Paola Giordano, Runhui Wu, Jie Ding, Wenyan Huang, Jianhua Mao, Päivi Lähteenmäki, Stephane Decramer, Toralf Bernig, Martin Chada, Godfrey Chan, Krisztian Kally, Beatrice Nolan, Shoshana Revel-Vilk, Hannah Tamary, Carina Levin, Daniela Tormene, Maria Abbattista, Andrea Artoni, Takanari Ikeyama, Ryo Inuzuka, Satoshi Yasukochi, Michelle Morales Soto, Karina A Solis Labastida, Monique H Suijker, Marike Bartels, Rienk Y Tamminga, C Heleen Van Ommen, D. Maroeska Te Loo, Rui Anjos, Lyudmila Zubarovskaya, Natalia Popova, Elena Samochatova, Margarita Belogurova, Pavel Svirin, Tatiana Shutova, Vladimir Lebedev, Olga Barbarash, Pei L Koh, Joyce C Mei, Ludmila Podracka, Ruben Berrueco, Maria F Fernandez, Tony Frisk, Sebastian Grunt, Johannes Rischewski, Manuela Albisetti-Pedroni, Ali Antmen, Huseyin Tokgoz, Zeynep Karakas, Jayashree Motwani, Michael Williams, John Grainger, Jeanette Payne, Mike Richards, Susan Baird, Neha Bhatnagar, Angela Aramburo, Shelley Crary, Tung Wynn, Shannon Carpenter, Sanjay Ahuja, Neil Goldenberg, Gary Woods, Kamar Godder, Ajovi Scott-Emuakpor, Gavin Roach, Leslie Raffini, Nirmish Shah, Sanjay Shah, Courtney Thornburg, Ayesha Zia, Roger Berkow, Medical University of Vienna, Vienna, Austria, CMR-M3C, Université Paris Descartes - Paris 5 (UPD5)-CHU Necker - Enfants Malades [AP-HP], Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Carl Gustav Carus University (DRESDEN - CGCU), Technische Universität Dresden (TUD), Pediatric Hematology, Emma Children's Hospital/Academic Medical Center, Department of Medicine, McMaster University [Hamilton, Ontario], Department of Earth and Environmental Sciences [Leuven-Heverlee], Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven), Service de Pédiatrie [HU Antwerp, Belgium], Antwerp University Hospital [Edegem] (UZA), Service de Pédiatrie - Néphrologie, Médecine interne, Hypertension, CHU Toulouse [Toulouse]-Hôpital des Enfants, CHU Toulouse [Toulouse], Pediatric Hematology/Oncology Department, Hadassah Hebrew University Medical Center [Jerusalem], Pediatric Hematology Unit (Pediatric Hematology Unit), Schneider Children's Medical Center of Israel, Hospital de Santa Cruz, Institute for Information Transmission Problems, Russian Academy of Sciences [Moscow] (RAS), Department of Paediatric Haematology, Hospital Sant Joan de Déu [Barcelona], Laboratoire d'Ecologie Microbienne - UMR 5557 (LEM), Centre National de la Recherche Scientifique (CNRS)-Ecole Nationale Vétérinaire de Lyon (ENVL)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Recherche Agronomique (INRA)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS), Department of Human Evolution [Leipzig], Max Planck Institute for Evolutionary Anthropology, Max-Planck-Gesellschaft-Max-Planck-Gesellschaft, Paediatric Haematology, UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Département de pédiatrie, RS: CAPHRI - R5 - Optimising Patient Care, Epidemiologie, MUMC+: KIO Kemta (9), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Technische Universität Dresden = Dresden University of Technology (TU Dresden), and Max Planck Institute for Evolutionary Anthropology [Leipzig]

Subjects
Male, Pediatrics, DRUG EFFICACY, [SDV]Life Sciences [q-bio], Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], FONDAPARINUX, RANDOMIZED CONTROLLED TRIAL, MAJOR CLINICAL STUDY, ADOLESCENT, LOW MOLECULAR WEIGHT HEPARIN, law.invention, Adolescent, Anticoagulants, Child, Child, Preschool, Female, Humans, Infant, Risk Factors, Rivaroxaban, Venous Thromboembolism, 0302 clinical medicine, Randomized controlled trial, CHILD, law, Medicine, PRIORITY JOURNAL, 610 Medicine & health, ANTICOAGULANT AGENT, oral rivaroxaban, HUMAN, RISK FACTOR, CLINICAL TRIAL, HUMANS, Hematology, DISEASE BURDEN, Thrombosis, 3. Good health, DRUG SAFETY, FEMALE, OPEN STUDY, FOLLOW UP, BLEEDING, 030220 oncology & carcinogenesis, medicine.drug, medicine.medical_specialty, INTENTION TO TREAT ANALYSIS, ANTICOAGULANTS, 03 medical and health sciences, ANTICOAGULATION, ANTIVITAMIN K, ARTICLE, Preschool, CHILD, PRESCHOOL, VENOUS THROMBOEMBOLISM, disease, MALE, business.industry, RIVAROXABAN, PHASE 3 CLINICAL TRIAL, medicine.disease, Clinical trial, CONTROLLED STUDY, THROMBOSIS, Clinical research, DEFINITION, Multicenter study, PRESCHOOL CHILD, HEPARIN, MULTICENTER STUDY, INFANT, business, Venous thromboembolism, TREATMENT OUTCOME, 030215 immunology
Abstract

Contains fulltext : 219893.pdf (Publisher’s version ) (Closed access) BACKGROUND: Treatment of venous thromboembolism in children is based on data obtained in adults with little direct documentation of its efficacy and safety in children. The aim of our study was to compare the efficacy and safety of rivaroxaban versus standard anticoagulants in children with venous thromboembolism. METHODS: In a multicentre, parallel-group, open-label, randomised study, children (aged 0-17 years) attending 107 paediatric hospitals in 28 countries with documented acute venous thromboembolism who had started heparinisation were assigned (2:1) to bodyweight-adjusted rivaroxaban (tablets or suspension) in a 20-mg equivalent dose or standard anticoagulants (heparin or switched to vitamin K antagonist). Randomisation was stratified by age and venous thromboembolism site. The main treatment period was 3 months (1 month in children /=1 dose), were centrally assessed by investigators who were unaware of treatment assignment. Repeat imaging was obtained at the end of the main treatment period and compared with baseline imaging tests. This trial is registered with ClinicalTrials.gov, number NCT02234843 and has been completed. FINDINGS: From Nov 14, 2014, to Sept 28, 2018, 500 (96%) of the 520 children screened for eligibility were enrolled. After a median follow-up of 91 days (IQR 87-95) in children who had a study treatment period of 3 months (n=463) and 31 days (IQR 29-35) in children who had a study treatment period of 1 month (n=37), symptomatic recurrent venous thromboembolism occurred in four (1%) of 335 children receiving rivaroxaban and five (3%) of 165 receiving standard anticoagulants (hazard ratio [HR] 0.40, 95% CI 0.11-1.41). Repeat imaging showed an improved effect of rivaroxaban on thrombotic burden as compared with standard anticoagulants (p=0.012). Major or clinically relevant non-major bleeding in participants who received >/=1 dose occurred in ten (3%) of 329 children (all non-major) receiving rivaroxaban and in three (2%) of 162 children (two major and one non-major) receiving standard anticoagulants (HR 1.58, 95% CI 0.51-6.27). Absolute and relative efficacy and safety estimates of rivaroxaban versus standard anticoagulation estimates were similar to those in rivaroxaban studies in adults. There were no treatment-related deaths. INTERPRETATION: In children with acute venous thromboembolism, treatment with rivaroxaban resulted in a similarly low recurrence risk and reduced thrombotic burden without increased bleeding, as compared with standard anticoagulants. FUNDING: Bayer AG and Janssen Research & Development. 01 januari 2020

Published
2020
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13. Data for life cycle assessment of legume biorefining for alcohol

Author

Sophie Saget, Theophile Lienhardt, Marcela Porto Costa, Pietro P. M. Iannetta, Michael Williams, Robert M. Rees, Graeme M. Walker, David Styles, Kirsty Black, Charles Spillane, and Dave Chadwick

Subjects
Nutrient cycle, DDGS, Animal feed, Agricultural engineering, lcsh:Computer applications to medicine. Medical informatics, Life cycle assessment, 03 medical and health sciences, Ingredient, 0302 clinical medicine, Legumes, Life cycle assessment, Biorefining, lcsh:Science (General), Life-cycle assessment, Legume, Distillation, 030304 developmental biology, 2. Zero hunger, 0303 health sciences, Multidisciplinary, Ethanol, LCA, Pea, food and beverages, Benchmarking, Legumes, Environmental Science, Sustainability, Environmental science, lcsh:R858-859.7, 030217 neurology & neurosurgery, lcsh:Q1-390
Abstract

Benchmarking the environmental sustainability of alcohol produced from legume starch against alcohol produced from cereal grains requires considering of crop production, nutrient cycling and use of protein-rich co-products via life cycle assessment. This article describes the mass balance flows behind the life cycle inventories for gin produced from wheat and peas (Pisum sativum L.) in an associated article summarising the environmental footprints of wheat- and pea-gin [1], and also presents detailed supplementary results. Activity data were collected from interviews with actors along the entire gin value chain including a distillery manager and ingredient and packaging suppliers. Important fertiliser and animal-feed substitution effects of co-product use were derived using detailed information and models on nutrient flows and animal feed composition, along with linear optimisation modelling. Secondary data on environmental burdens of specific materials and processes were obtained from the Ecoinvent v3.4 life cycle assessment database. This article provides a basis for further quantitative evaluation of the environmental sustainability of legume-alcohol value chains. Keywords: Pea, Legumes, Life cycle assessment, LCA, Animal feed, DDGS, Distillation, Ethanol

Published
2019

14. Contributors

Author

Yasir AlSiraj, Sarah E. Baker, Maria Louisa Barcena, Giannie Barsha, Cynthia Bean, Stephane L. Bourque, Heddwen L. Brooks, Lisa A. Cassis, Denise C. Cornelius, Sandra T. Davidge, Melinda B. Davis, Hester den Ruijter, Kate M. Denton, Claire S. Duvernoy, Anouk Eikendal, Anne Garnier, Vesna D. Garovic, Styliani Goulopoulou, Inga Harbuz-Miller, Sharonda Harris, Robin Hartman, Meredith Hay, Nathaniel Husband, Alan Kim Johnson, Michael Joyner, Andrea G. Kattah, Kris Kawamoto, Edmund Kwok, Guido Lastra, Jacqueline K. Limberg, Analia S. Loria, Camila M. Manrique, James N. Martin, Keisa W. Mathis, Louise D. McCullough, Abraham Morgentaler, Rachael F. Morris, Quin Pham, Grace S. Pham, Dennis P. Pollow, Bibek Poudel, Sushant M. Ranadive, Jane F. Reckelhoff, Vera Regitz-Zagrosek, Damian G. Romero, Meaghan Roy-O’Reilly, Willis K. Samson, Corbin A. Shields, James R. Sowers, Sean E. Thatcher, Edgar D. Torres Fernandez, Abdulmaged M. Traish, Josh Uhlorn, Renee Ventura-Clapier, Kedra Wallace, Sarah L. Walton, Jan Michael Williams, Cassandra Woolley, Baojian Xue, Licy L. Yanes Cardozo, and Gina L.C. Yosten

Published
2019
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15. Contributors

Author

David J. Abson, Eduardo Aguilera, Bagoré Bathily, Philippe Baveye, Nicolas Béfort, Tim G. Benton, Isabelle Bertrand, Gilles Billen, Juliette Bloor, Timothy M. Bowles, Vincent Bretagnolle, Toby J.A. Bruce, Gianluca Brunori, Mauroni Alves Cangussú, Paulo César de F. Carvalho, Abad Chabbi, Julian Chará, Juan Cruz Colazo, Christian Corniaux, Carlos Alexandre Costa Crusciol, Simona D'Amico, William Deen, Leonardo Deiss, Luc Delaby, Christian Dupraz, Michel Duru, Martha Xochitl Flores Estrada, Alan J. Franzluebbers, Doreen Gabriel, Josette Garnier, Francois Gastal, Amélie C.M. Gaudin, Bernard Giroud, John Gowdy, Henrik Hauggaard-Nielsen, Laura Henckel, John Hendrickson, Olivier Huguenin-Elie, Christian Huyghe, Erik Steen Jensen, Eric Justes, David Kleijn, Katia Klumpp, Hein Korevaar, Scott L. Kronberg, Pierre Labarthe, Claudete Reisdorfer Lang, Gwenaëlle Lashermes, Luis Lassaletta, Gerry Lawson, Philippe Lecomte, Gilles Lemaire, Julia Le Noë, Philippe Leterme, Isabelle Litrico, Marie-Benoit Magrini, Marty D. Matlock, Rogerio Martins Mauricio, Vanessa E. McMillan, Zia Mehrabi, Paul Miguet, Anibal de Moraes, Enrique Murgueitio, Thomas Nesme, Paul Neve, Martino Nieddu, Domingos Sávio Campos Paciullo, Cristiano Magalhães Pariz, Sylvain Pellerin, Mark B. Peoples, L.D.A.S. Pontes, Sylvie Recous, John Regan, Leah L.R. Renwick, Rafael Sandin Ribeiro, Aude Ridier, Adanella Rossi, Cornelia Rumpel, Julie Ryschawy, Alberto Sanz-Cobeña, J. Schellberg, Verena Seufert, Gavin Siriwardena, Jonathan Storkey, R. Mark Sulc, J.P. Theau, O. Therond, Clement A. Tisdell, Cairistiona F.E. Topp, Françoise Vertès, Christine A. Watson, Jeroen Watté, Michael Williams, and Clevo Wilson

Published
2019
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16. A framework of integrating knowledge of human factors to facilitate HMI and collaboration in intelligent manufacturing

Author

Michael Williams, Ying Liu, Maneesh Kumar, and Harley Oliff

Subjects
0209 industrial biotechnology, Process management, T1, Computer science, business.industry, media_common.quotation_subject, 02 engineering and technology, Automation, TS, Field (computer science), 020901 industrial engineering & automation, TA, Component (UML), 0202 electrical engineering, electronic engineering, information engineering, General Earth and Planetary Sciences, Production (economics), 020201 artificial intelligence & image processing, Quality (business), business, Productivity, General Environmental Science, media_common
Abstract

Recent developments in the field of intelligent manufacturing have led to increased levels of automation and robotic operators becoming commonplace within manufacturing processes. However, the human component of such systems remains prevalent, resulting in significant disturbance and uncertainty. Consequently, semi-automated processes are difficult to optimise. This paper studies the relationships between robotic and human operators to develop the understanding of how the human influence affects these production processes, and proposes a framework to integrate and implement knowledge of such factors, with the aim of improving Human-Machine-Interaction, facilitating bi-directional collaboration, and increasing productivity and quality, supported by an example case-study.

Published
2018

17. Reporting Results

Author

Kevin Mullane, Michael Williams, and Michael J. Curtis

Subjects
Negotiation, Medical education, Process (engineering), media_common.quotation_subject, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, ComputerApplications_COMPUTERSINOTHERSYSTEMS, Peer group, Psychology, IMRAD, media_common
Abstract

Preparing a manuscript for peer review is the culmination of the activities of a research project and provides an appropriate forum to present the findings of the project to an appropriate peer group. The manuscript should typically follow the IMRAD (introduction, methods, results, and discussion) format used by a majority of biomedical research journals. The passage of a submitted manuscript through the peer review process can be greatly facilitated by following the preparation guidelines and checklists provided by the target journal and by also ensuring that the manuscript communicates the findings and conclusions in a logical and transparent manner and does not overstate the findings. Additionally, by negotiating the peer review process in a collegial, proactive manner, authors can expedite the process while often improving their manuscript as the result of reviewer and editorial feedback.

Published
2018
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18. Experimental Planning and Execution

Author

Kevin Mullane, Michael Williams, and Michael J. Curtis

Subjects
0301 basic medicine, Authentication, business.industry, Computer science, Best practice, Inference, Machine learning, computer.software_genre, Misuse of statistics, 03 medical and health sciences, Annotation, 030104 developmental biology, 0302 clinical medicine, Statistical analysis, Artificial intelligence, Raw data, business, computer, Garbage, 030217 neurology & neurosurgery
Abstract

The lack of reproducibility in biomedical research has been consistently attributed to the misuse of statistics, naive inference/extrapolation from animal models, and fraud. However, optimization of statistical analysis and caution in interpreting experimental outcomes cannot overcome flaws in experimental design and execution. These include: the absence of a credible hypothesis for running an experiment; clearly defining outcomes before the experiment is run; the use of appropriate controls, randomization of subjects; the validation/authentication of all reagents (compounds, cell lines, animals, antibodies) and equipment; the collection, preservation, and annotation of raw data; and steps to contain or eliminate investigator bias. Collectively these measures will avoid a GIGO (garbage in, garbage out) paradigm that no amount of postexperimental tinkering, including P-hacking, can objectively and legitimately correct. The present chapter addresses measures to facilitate best practices in experimental design and execution that will aid in improving reproducibility.

Published
2018
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19. Addressing Reproducibility: Peer Review, Impact Factors, Checklists, Guidelines, and Reproducibility Initiatives

Author

Kevin Mullane, Michael J. Curtis, and Michael Williams

Subjects
0301 basic medicine, Reproducibility, Knowledge management, Process management, Impact factor, business.industry, Process (engineering), media_common.quotation_subject, Best practice, Stakeholder, Transparency (behavior), 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Medicine, Quality (business), business, Productivity, 030217 neurology & neurosurgery, media_common
Abstract

The biomedical research community has identified several approaches to address concerns regarding the lack of reproducibility in research. These include: improving the classical peer review (CPR) process via alternatives that can improve transparency and replace/supplement CPR stakeholder biases; open access publishing forums; alternatives to the Journal Impact Factor as improved metrics for researcher productivity; guidelines and checklists to improve the quality, transparency and reporting of data; and formal Reproducibility Initiatives (RIs) to replace the seminal process of scientific self- correction. While well intended, many of these initiatives have added to the existing problems while creating new ones. Furthermore, the outcomes from the RIs reported to date have been uniformly disappointing. Measures to improve reproducibility must focus on: improving training in best practices in experimental design, execution, and analysis that will aid in avoiding the persistence of behaviors detrimental to reproducibility while encouraging responsible research conduct.

Published
2018
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20. Biomedical Research in the 21st Century: Multiple Challenges in Resolving Reproducibility Issues

Author

Michael J. Curtis, Michael Williams, and Kevin Mullane

Subjects
0301 basic medicine, Value (ethics), business.industry, Unintended consequences, media_common.quotation_subject, Nanotechnology, Context (language use), Disruptive technology, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Incentive, Health care, Medicine, Quality (business), Engineering ethics, business, Productivity, 030217 neurology & neurosurgery, media_common
Abstract

The documented lack of reproducibility in biomedical research directly impacts the value and output of drug discovery disciplines like pharmacology that are integral for understanding disease pathophysiology, the discovery of drug targets, and the development of new drug candidates. This chapter discusses the reproducibility issue in the context of the challenges facing the biopharmaceutical industry in the 21st century. These include drug costs and productivity; the perceived impact of the biotechnology revolution and newer disruptive technology initiatives from Silicon Valley companies. These issues are placed in the context of the systemic flaws and perverse career incentives that characterize the current biomedical research culture, the unintended consequences from which appear to sufficient consequences to change behaviors that result in bad science. This emphasizes the need for the biomedical research community to proactively improve reproducibility via initiatives like the recent AAM Framework for Improving the Quality of Research.

Published
2018
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22. Reproducibility in Biomedical Research

Author

Michael Williams, Kevin Mullane, and Michael J. Curtis

Subjects
0301 basic medicine, media_common.quotation_subject, Translational research, Causality, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Human disease, Political science, Credibility, Relevance (law), Engineering ethics, Quality (business), 030217 neurology & neurosurgery, Reliability (statistics), media_common
Abstract

The biomedical research ecosystem—academic, federal, and industrial—is dedicated to understanding human disease causality and developing effective therapeutics. The successes of this system over the past century have resulted in many effective drugs leading society to expect an endless supply of new therapeutics, particularly for chronic diseases that lack effective treatments (e.g., Alzheimer’s, diabetes). An increased recognition that the quality, relevance, reliability, and reproducibility of biomedical research cannot be guaranteed despite self-correction and peer review, coupled with the incessant hyping of inconsequential data by authors and their institutions, has led to a situation that is incompatible with sustained success in drug discovery. This risks the loss of credibility with the public, which does not bode well for the future of biomedical research. This chapter outlines the reproducibility problem and its magnitude, setting the stage for potential solutions that are discussed elsewhere in this monograph.

Published
2018
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24. Development of directed randomization for discussing a minimal security architecture

Author

Henrique Oyama, Dominic Messina, Keshav Kasturi Rangan, Akkarakaran Francis Leonard, Kip Nieman, Helen Durand, Katie Tyrrell, Katrina Hinzman, and Michael Williamson

Subjects
Control system cybersecurity, Active attack detection, Smart manufacturing, Model predictive control, Image-based control, Chemical engineering, TP155-156, Information technology, T58.5-58.64
Abstract

Strategies for mitigating the impacts of cyberattacks on control systems using a control-oriented perspective have become of greater interest in recent years. Our group has contributed to this trend by developing several methods for detecting cyberattacks on process sensors, actuators, or both sensors and actuators simultaneously using an advanced optimization-based control strategy known as Lyapunov-based economic model predictive control (LEMPC). However, each technique comes with benefits and limitations, both with respect to one another and with respect to traditional information technology and computer science-type approaches to cybersecurity. An important question to ask, therefore, is what the goal should be of the development of new control-based techniques for handling cyberattacks on control systems, and how we will be able to benchmark these as “successful” compared to other techniques to drive development or signal when the research in this direction has reached maturity. In this paper, we propose that the goal of research in control system cybersecurity for next-generation manufacturing should be the development of a security architecture that provides flexibility and safety with lowest cost, and seek to clarify this concept by re-analyzing some of the security techniques from our prior work in such a context. We also show how new methods can be developed and analyzed within this “minimum security architecture” context by proposing a technique which we term “directed randomization” that may require less sensors to be secured in a system than some of our prior methods, potentially adding flexibility to the system while still maintaining security. Directed randomization seeks to utilize the existence of two possible stabilizing inputs at every sampling time to attempt to create a challenge for an attacker for setting up an arbitrary sensor attack policy without being detected within a finite number of sampling periods. We discuss benefits and limitations of this technique with respect to our prior cybersecurity strategies and also with respect to extended versions of these prior concepts, such as image-based control and distributed control, to provide further insights into the minimum security concept.

Published
2023
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26. Contributors

Author

Sanjib Adhikary, Jorge Aguilar, Charles Ahere, Moustafa Ahmed, Jane C. Ahn, Shamsuddin Akhtar, David B. Albert, Nasrin N. Aldawoodi, John T. Algren, Gracie Almeida-Chen, David Amar, Zirka H. Anastasian, Stephen Aniskevich, Solomon Aronson, Harendra Arora, Amit Asopa, Joshua H. Atkins, John G. Augoustides, Mohammad Fareed Azam, Catherine R. Bachman, Douglas R. Bacon, Andrew D. Badley, Emily Baird, Alethia Baldwin, Ryan Ball, Amir Baluch, David Bandola, Shawn Banks, Paul G. Barash, Kathleen E. Barrett, Shawn T. Beaman, Jonathan C. Beathe, Christopher D. Beatie, W. Scott Beattie, Perry S. Bechtle, G. Richard Benzinger, Lauren Berkow, Jeffrey M. Berman, Wendy K. Bernstein, Arnold J. Berry, Frederic Berry, Ulrike Berth, Walter Bethune, Sumita Bhambhani, Shobana Bharadwaj, Neil Bhatt, Frederic T. Billings, Wendy B. Binstock, David J. Birnbach, Michael Bishop, Stephanie Black, Mary A. Blanchette, James M. Blum, Krishna Boddu, Lara Bonasera, Richard L. Boortz-Marx, Cecil O. Borel, Gregory H. Botz, Charles D. Boucek, William Bradford, Jason C. Brainard, Michelle Braunfeld, Ferne R. Braveman, Caridad Bravo-Fernandez, Peter H. Breen, Marjorie Brennan, Tricia Brentjens, Megan A. Brockel, Jay B. Brodsky, Todd A. Bromberg, Adam J. Broussard, Chris Broussard, Carmen Labrie-Brown, Robert H. Brown, Charles S. Brudney, Sorin J. Brull, Claude Brunson, Trent Bryson, Jacob M. Buchowski, Stefan Budac, Zachary D. Bush, John Butterworth, Lisbeysi Calo, Christopher Canlas, Ayana Cannon, Shawn M. Cantie, Lisa Caplan, Marco Caruso, Davide Cattano, Charles B. Cauldwell, Laura Cavallone, Maurizio Cereda, Thomas M. Chalifoux, Susan Chan, Theodore G. Cheek, Alexander Chen, Samuel A. Cherry, Albert T. Cheung, Grace L. Chien, Peter T. Choi, Christopher Ciarallo, Franklyn Cladis, Anthony J. Clapcich, Richard B. Clark, Mindy Cohen, Neal H. Cohen, Robert I. Cohen, Stephan J. Cohn, Aisling Conran, Richard I. Cook, Randall F. Coombs, David M. Corda, Daniel Cormican, Darren Cousin, Vincent S. Cowell, Lyndsey Cox, Paula A. Craigo, Richard C. Cross, Roy F. Cucchiara, William H. Daily, Gaurang Dalal, Priti Dalal, Michael Danekas, Ahmed M. Darwish, Ribal Darwish, Suanne M. Daves, Kathleen Davis, Peter J. Davis, Bracken J. De Witt, Ellise Delphin, Seema Deshpande, Dawn P. Desiderio, Tricia Desvarieux, Laura K. Diaz, Christian Diez, Sanjay Dixit, Meenakshi Dogra, Karen B. Domino, Kathryn Dorhauer, Todd Dorman, Don D. Doussan, James Duke, Ann C. Duncan, Frank W. Dupont, Andrew Dziewit, L. Jane Easdown, R. Blaine Easley, Thomas J. Ebert, David M. Eckmann, Talmage D. Egan, Seth Eisdorfer, Nabil M. Elkassabany, Ryan P. Ellender, Logan S. Emory, Monique Espinosa, Lucinda L. Everett, Nauder Faraday, James J. Fehr, James M. Feld, Lynn A. Fenton, Laura H. Ferguson, Matthew Fiegel, Aaron M. Fields, Gordon N. Finlayson, Alan Finley, Gregory W. Fischer, Gary Fiskum, Molly Fitzpatrick, Russell Flatto, Lee A. Fleisher, Ronda Flower, Annette G. Folgueras, Patrick J. Forte, Joseph F. Foss, Charles J. Fox, William R. Furman, Robert Gaiser, David R. Gambling, Scott Gardiner, Matthew L. Garvey, Abraham C. Gaupp, Steven Gayer, Jeremy M. Geiduschek, Frank Gencorelli, Eric Gewirtz, Ghaleb A. Ghani, Charles P. Gibbs, Jeremy L. Gibson, Lori Gilbert, Kevin J. Gingrich, Gregory Ginsburg, Christopher Giordano, Christine E. Goepfert, Hernando Gomez, Santiago Gomez, Alanna E. Goodman, Stephanie R. Goodman, Alexandru Gottlieb, Ori Gottlieb, Allan Gottschalk, Basavana Gouda Goudra, Harry J. Gould, Nikolaus Gravenstein, Megan Graybill, William J. Greeley, Patrick Guffey, Ala Sami Haddadin, John G. Hagen, Karim Abdel Hakim, Michael Hall, N. James Halliday, Raafat S. Hannallah, Jeremy Hansen, C. William Hanson, Charles B. Hantler, Andrew P. Harris, Jonathan Hastie, Henry A. Hawney, Stephen O. Heard, James E. Heavner, James G. Hecker, Elizabeth A. Hein, Eugenie Heitmiller, Mark Helfaer, Lori B. Heller, Andrew Hemphill, Adrian Hendrickse, Frederick A. Hensley, Ian A. Herrick, Douglas Hester, Eric J. Heyer, Michael S. Higgins, Roberta Hines, Charles W. Hogue, Kenneth J. Holroyd, Natalie F. Holt, Simon J. Howell, Faisal Huda, Keith E. Hude, Hayden R. Hughes, James M. Hunter, Brad J. Hymel, James W. Ibinson, Karen E. Iles, Robert M. Insoft, Shiroh Isono, Yulia Ivashkov, Bozena R. Jachna, Anna Jankowska, Norah Janosy, Arun L. Jayaraman, Nathalia Jimenez, Judy G. Johnson, Lyndia Jones, Edmund H. Jooste, Zeev N. Kain, Maudy Kalangie, Philip L. Kalarickal, Ihab Kamel, Mia Kang, Ivan Kangrga, Ravish Kapoor, Helen W. Karl, Christopher Karsanac, Swaminathan Karthik, Jeffrey A. Katz, Alan Kaye, Adam M. Kaye, A. Murat Kaynar, Nancy B. Kenepp, Miklos D. Kertai, Mary A. Keyes, Sarah Khan, Swapnil Khoche, David Y. Kim, Jerry H. Kim, Kimberly M. King, Jeffrey Kirsch, Matthew A. Klopman, Paul R. Knight, Donald D. Koblin, W. Andrew Kofke, Vincent J. Kopp, Joseph R. Koveleskie, Courtney Kowalczyk, Valeriy V. Kozmenko, Kaylyn Krummen, Sapna R. Kudchadkar, Nathan Kudrick, Adrienne Kung, C. Dean Kurth, Robert Kyle, J. Lance LaFleur, Jason G. Lai, Kirk Lalwani, William L. Lanier, Dawn M. Larson, Richard M. Layman, Chris C. Lee, Mark J. Lema, W. Casey Lenox, Jacqueline M. Leung, Roy C. Levitt, Jerrold H. Levy, J. Lance Lichtor, Charles Lin, Sharon L. Lin, Karen S. Lindeman, Lesley Lirette, Ronald S. Litman, Qianjin Liu, Renyu Liu, Wen-Shin Liu, Justin Lockman, Stanley L. Loftness, Martin J. London, Philip D. Lumb, M. Concetta Lupa, Anne Marie Lynn, Devi Mahendran, Jeffrey Mako, Anuj Malhotra, Vinod Malhotra, Andrew M. Malinow, Mark G. Mandabach, Dennis T. Mangano, Sobia Mansoor, Inna Maranets, Jonathan B. Mark, Sinisa Markovic, H. Michael Marsh, Choendal Martin, Nicole D. Martin, Douglas Martz, Veronica A. Matei, Letha Mathews, Lynne G. Maxwell, Philip McArdle, John P. McCarren, Brenda C. McClain, Brian McClure, William A. McDade, Kathryn E. McGoldrick, Brian J. McGrath, Gregory L. McHugh, David McIlroy, Jason McKeown, Thomas M. McLoughlin, R. Yan McRae, William L. Meadow, Sameer Menda, William T. Merritt, David G. Metro, Berend Mets, Hosni Mikhaeil, David W. Miller, Jessica Miller, Mohammed Minhaj, Marek A. Mirski, Nanhi Mitter, Alexander J.C. Mittnacht, Raj K. Modak, Pierre Moine, Constance L. Monitto, Richard C. Month, Richard E. Moon, Laurel E. Moore, Roger A. Moore, Thomas A. Moore, Debra E. Morrison, Jonathan Moss, John R. Moyers, Jesse J. Muir, Adam J. Munson-Young, Stanley Muravchick, John M. Murkin, Peter Nagele, Peter A. Nagi, Daniel A. Nahrwold, Michael L. Nahrwold, Madhavi Naik, Manchula Navaratnam, Stephan P. Nebbia, Priscilla Nelson, Thai T. Nguyen, Viet Nguyen, Stavroula Nikolaidis, Zoulfira Nisnevitch, Dolores B. Njoku, Mary J. Njoku, Edward J. Norris, Omonele O. Nwokolo, Daniel Nyhan, William T. O'Byrne, Edward A. Ochroch, Andrew Oken, Nathan Orgain, Nancy E. Oriol, Pedro Orozco, Andreas M. Ostermeier, Andranik Ovassapian, Mehmet S. Ozcan, Ira Padnos, Sheela S. Pai, Nirvik Pal, Dhamodaran Palaniappan, Susan K. Palmer, Howard D. Palte, Wei Pan, Oliver Panzer, Sibi Pappachan, Anthony Passannante, Dennis A. Patel, Dilipkumar K. Patel, Kirit M. Patel, Samir Patel, Shalin Patel, Sanup Pathak, Minda L. Patt, Ronald W. Pauldine, Olga Pawelek, Tim Pawelek, Kiarash Paydar, Ronald G. Pearl, Christine Peeters-Asdourian, Padmavathi R. Perela, Charise T. Petrovitch, Patricia H. Petrozza, Dennis Phillips, Mark C. Phillips, Christine Piefer, Edgar J. Pierre, S. William Pinson, Evan G. Pivalizza, Raymond M. Planinsic, Don Poldermans, Joel M. Pomerantz, Jason E. Pope, Wanda M. Popescu, Vivian H. Porche, Jahan Porhomayon, Dmitry Portnoy, Corinne K. Postle, Paul J. Primeaux, Donald S. Prough, Ferenc Puskas, Carlos A. Puyo, Forrest Quiggle, Mary Rabb, Bronwyn R. Rae, Muhammad B. Rafique, Jesse M. Raiten, Arvind Rajagopal, Srinivasan Rajagopal, Gaurav Rajpal, Chandra Ramamoorthy, Ira J. Rampil, James G. Ramsay, James A. Ramsey, Vidya N. Rao, Joana Ratsiu, Selina Read, Ronjeet Reddy, Leila L. Reduque, David L. Reich, Karene Ricketts, Cameron Ricks, Bernhard Riedel, Jyotsna Rimal, Joseph Rinehart, James M. Riopelle, Stacey A. Rizza, Amy C. Robertson, Stephen Robinson, Peter Rock, Yillam F. Rodriguez-Blanco, Michael F. Roizen, Daniel M. Roke, Ryan Romeo, Joseph Rosa, David A. Rosen, Kathleen Rosen, Stanley H. Rosenbaum, Andrew D. Rosenberg, Andrew L. Rosenberg, Henry Rosenberg, Meg A. Rosenblatt, Steven Roth, Brian Rothman, Justin L. Rountree, Matthew J. Rowan, Marc Rozner, Ryan Rubin, Stephen M. Rupp, W. John Russell, Thomas A. Russo, Alecia L. Sabartinelli, Tetsuro Sakai, Orlando J. Salinas, Paul L. Samm, Jibin Samuel, Tor Sandven, Ted J. Sanford, Joshua W. Sappenfield, Ponnusamy Saravanan, Subramanian Sathishkumar, R. Alexander Schlichter, Eric Schnell, David L. Schreibman, Armin Schubert, Peter Schulman, Todd A. Schultz, Alan Jay Schwartz, Jamie McElrath Schwartz, Jeffrey J. Schwartz, Benjamin K. Scott, Joseph L. Seltzer, Tamas Seres, Daniel I. Sessler, Navil F. Sethna, Amar Setty, Paul W. Shabaz, Pranav Shah, Saroj Mukesh Shah, Milad Sharifpour, Joanne Shay, Jay Shepherd, Jeffrey S. Shiffrin, Marina Shindell, Daniel Siker, Richard Silverman, Brett A. Simon, Nina Singh, Ashish C. Sinha, Robert N. Sladen, Kieran A. Slevin, Tod B. Sloan, Kathleen Smith, Timothy E. Smith, Victoria Smoot, Denis Snegovskikh, Betsy Ellen Soifer, Molly Solorzano, James M. Sonner, Aris Sophocles, James A. Sparrow, Joan Spiegel, Bruce D. Spiess, Ramprasad Sripada, Stanley W. Stead, Joshua D. Stearns, Kelly Stees, Clinton Steffey, Christopher Stemland, John Stene, Christopher T. Stephens, Tracey L. Stierer, O. Jameson Stokes, Bryant W. Stolp, David F. Stowe, Ted Strickland, Suzanne Strom, Erin A. Sullivan, Michele Sumler, Dajin Sun, Lena Sun, Esther Sung, Veronica C. Swanson, Judit Szolnoki, Joe Talarico, Gee Mei Tan, Darryl T. Tang, Paul Tarasi, René Tempelhoff, John E. Tetzlaff, Alisa C. Thorne, Arlyne Thung, Vasanti Tilak, Kate Tobin, Joseph R. Tobin, Michael J. Tobin, R. David Todd, Matthew Tomlinson, Thomas J. Toung, Lien B. Tran, Minh Chau Joe Tran, Kevin K. Tremper, Sanyo Tsai, George S. Tseng, Kenneth J. Tuman, Avery Tung, Cynthia Tung, Rebecca Twersky, Mark Twite, John A. Ulatowski, Michael Urban, Manuel C. Vallejo, Andrea Vannucci, Albert J. Varon, Anasuya Vasudevan, Susheela Viswanathan, Alexander A. Vitin, Wolfgang Voelckel, Ann Walia, Russell T. Wall, Terrence Wallace, Shu-Ming Wang, David C. Warltier, Lucy Waskell, Scott Watkins, Denise Wedel, Stuart J. Weiss, Charles Weissman, Nathaen Weitzel, Gregory Weller, Gina Whitney, Robert A. Whittington, Danny Wilkerson, Nancy C. Wilkes, Michael Williams, Jimmy Windsor, Bernard Wittels, Gregory A. Wolff, Andrew K. Wong, Stacie N. Woods, A.J. Wright, Zheng Xie, Christopher C. Young, Ian Yuan, Francine S. Yudkowitz, James R. Zaidan, Paul Zanaboni, Warren M. Zapol, Angela Zimmerman, and Maurice S. Zwass

Published
2011
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27. Preface

Author

Michael Williams and S.J. Enna

Subjects
business.industry, Drug approval, Medicine, Nanotechnology, Engineering ethics, Current (fluid), business
Published
2009
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29. Defining the Role of Pharmacology in the Emerging World of Translational Research

Author

S. J. Enna and Michael Williams

Subjects
Clinical pharmacology, Pharmacological research, business.industry, Drug discovery, Systems biology, Translational research, Molecular Pharmacology, Pharmacology, law.invention, Food and drug administration, Clinical trial, law, Medicine, business
Abstract

Pharmacology is focused on studying the effects of endogenous agents and xenobiotics on tissue and organ function. Analysis of the concentration/response relationship is the foundation for these assessments as it provides quantifiable information on compound efficacy, potency, and, ultimately, side-effect liability and therapeutic index. Historically, pharmacology has been viewed as a unifying, hierarchically integrated, and technologically agnostic discipline. Besides being important in the development of new medications, pharmacological research has led to a better understanding of disease pathogenesis and progression. By defining the effects of compounds in vitro and in vivo, pharmacology has provided the means to validate, optimize, and advance new chemical entities (NCEs) to human testing. With the advent of molecular biology-based assay systems and a technology-driven (high-throughput screening, combinatorial chemistry, SNP mapping, systems biology) reductionistic focus, the integrated, hypothesis-driven pharmacological approach to drug discovery has been de-emphasized in recent years. This shift in research emphasis is now viewed by many as a major factor in the decline of new drug approvals and has led to various initiatives, the most notable being the Critical Path and Phase 0 clinical trial initiatives launched by the US Food and Drug Administration (FDA). These programs underscore the growing need for individuals trained in integrative pharmacology and having a background in molecular pharmacology to drive the drug discovery process and to fostering the translational research that is now considered vital for more rapidly identifying novel, more effective, and safer medications.

Published
2009
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33. Erythro-9-(2 Hydroxy 3-Nonyl)Adenine

Author

Michael Williams

Subjects
chemistry.chemical_classification, Adenosine deaminase, Enzyme, biology, Biochemistry, 9-(2-hydroxy-3-nonyl)adenine, Catabolism, Chemistry, biology.protein, medicine, Diastereomer, EHNA, medicine.drug
Abstract

Erythro-9-(2 Hydroxy 3-Nonyl)Adenine (EHNA) is a potent and selective inhibitor of the catabolic enzyme, adenosine deaminase (ADA: EC 3.5.4.4), an …

Published
2007
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