53 research outputs found
Naturalizing Orchids and the Hawaii Pacific Weed Risk Assessment System
This report examines the process of orchid naturalization, and the possiblity of orchids as invasive species
A programme for risk assessment and minimisation of progressive multifocal leukoencephalopathy developed for vedolizumab clinical trials
Introduction Over the past decade, the potential for drug-associated progressive multifocal leukoencephalopathy (PML) has become an increasingly important consideration in certain drug development programmes, particularly those of immunomodulatory biologics. Whether the risk of PML with an investigational agent is proven (e.g. extrapolated from relevant experience, such as a class effect) or merely theoretical, the serious consequences of acquiring PML require careful risk minimisation and assessment. No single standard for such risk minimisation exists. Vedolizumab is a recently developed monoclonal antibody to α4β7 integrin. Its clinical development necessitated a dedicated PML risk minimisation assessment as part of a global preapproval regulatory requirement.
Objective The aim of this study was to describe the multiple risk minimisation elements that were incorporated in vedolizumab clinical trials in inflammatory bowel disease patients as part of the risk assessment and minimisation of PML programme for vedolizumab.
Methods A case evaluation algorithm was developed for sequential screening and diagnostic evaluation of subjects who met criteria that indicated a clinical suspicion of PML. An Independent Adjudication Committee provided an independent, unbiased opinion regarding the likelihood of PML.
Results Although no cases were detected, all suspected PML events were thoroughly reviewed and successfully adjudicated, making it unlikely that cases were missed.
Conclusion We suggest that this programme could serve as a model for pragmatic screening for PML during the clinical development of new drugs
Implementation of the AAP Recommendations to Reduce SIDS Risk in NICUs: A Collaborative Study of Nursing Knowledge and Practice
Purpose:
To examine and describe NICU nurses’:
Knowledge of SIDS risk reduction measures
Modeling of safe infant sleep interventions prior to hospital discharge
Inclusion of SIDS risk reduction in parent educatio
Habituated, Tolerant, or Salt-conditioned Mountain Goats and Human Safety
Interactions between humans and wildlife include a number of consumptive and non-consumptive forms. In some cases, the increased demand for wildlife viewing can precipitate new human–wildlife conflicts. Mountain goats (Oreamnos americanus; goats) are native to a number of North American mountain ranges from southeastern Alaska to southwestern Montana, USA. Goat habitat typically consists of steep terrain and cold weather habitats, which has left them particularly vulnerable to climate change. Their alpine environments also make them vulnerable to disturbance by aircraft and land-based motorized human activity. We reviewed and characterized situations in which goats in close proximity to humans on foot may become a nuisance or dangerous to people. We identify how such interactions might occur, focusing on the array of intensity observed in different settings. We summarize and evaluate interventions that have been attempted and may warrant additional research. Goats that tolerate people along hiking trails, perhaps through a habituation-like process, can typically be kept at a safe distance simply by shouting, clapping hands, or vigorous gestures. Goats that have learned to associate people with a salt reward (e.g., typically urine deposited on the ground, less frequently sweat obtained directly by licking) are more likely to be successfully hazed by tossing small stones, hitting the animal in the flank or rear. Salt-conditioned goats sometimes come within touching distance of humans; we strongly advise against prodding or poking these animals with sharp objects such as trekking poles. The recreating public that ventures into goat habitat is the ultimate source of these conflicts. Education, compliance, and possibly some infrastructure improvements can lessen the potential for conflicts and provide new and safer opportunities to view goats
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The Challenge of Spoken Language Systems: Research Directions for the Nineties
A spoken language system combines speech recognition, natural language processing and human interface technology. It functions by recognizing the person's words, interpreting the sequence of words to obtain a meaning in terms of the application, and providing an appropriate response back to the user. Potential applications of spoken language systems range from simple tasks, such as retrieving information from an existing database (traffic reports, airline schedules), to interactive problem solving tasks involving complex planning and reasoning (travel planning, traffic routing), to support for multilingual interactions. We examine eight key areas in which basic research is needed to produce spoken language systems: (1) robust speech recognition; (2) automatic training and adaptation; (3) spontaneous speech; (4) dialogue models; (5) natural language response generation; (6) speech synthesis and speech generation; (7) multilingual systems; and (8) interactive multimodal systems. In each area, we identify key research challenges, the infrastructure needed to support research, and the expected benefits. We conclude by reviewing the need for multidisciplinary research, for development of shared corpora and related resources, for computational support and far rapid communication among researchers. The successful development of this technology will increase accessibility of computers to a wide range of users, will facilitate multinational communication and trade, and will create new research specialties and jobs in this rapidly expanding area
Recommended from our members
The Challenge of Spoken Language Systems: Research Directions for the Nineties
A spoken language system combines speech recognition, natural language processing and human interface technology. It functions by recognizing the person's words, interpreting the sequence of words to obtain a meaning in terms of the application, and providing an appropriate response back to the user. Potential applications of spoken language systems range from simple tasks, such as retrieving information from an existing database (traffic reports, airline schedules), to interactive problem solving tasks involving complex planning and reasoning (travel planning, traffic routing), to support for multilingual interactions. We examine eight key areas in which basic research is needed to produce spoken language systems: (1) robust speech recognition; (2) automatic training and adaptation; (3) spontaneous speech; (4) dialogue models; (5) natural language response generation; (6) speech synthesis and speech generation; (7) multilingual systems; and (8) interactive multimodal systems. In each area, we identify key research challenges, the infrastructure needed to support research, and the expected benefits. We conclude by reviewing the need for multidisciplinary research, for development of shared corpora and related resources, for computational support and far rapid communication among researchers. The successful development of this technology will increase accessibility of computers to a wide range of users, will facilitate multinational communication and trade, and will create new research specialties and jobs in this rapidly expanding area
Cosmopolitan Sentiment: Politics, Charity, and Global Poverty
Duties to address global poverty face a motivation gap. We have good reasons for acting yet we do not, at least consistently. A ‘sentimental education’, featuring literature and journalism detailing the lives of distant others has been suggested as a promising means by which to close this gap (Nussbaum in Upheavals of Thought: The Intelligence of Emotions, CUP, Cambridge, 2001; Rorty in Truth and Progress: Philosophical Papers, vol. 3, CUP, Cambridge, 1998). Although sympathetic to this project, I argue that it is too heavily wed to a charitable model of our duties to address global poverty—understood as requiring we sacrifice a certain portion of our income. However, political action, aimed at altering institutions at both a global and a local level is likely to be necessary in order to provide effective long-term solutions to poverty globally. To rectify this, the article develops an alternative dialogical account of sentimental education, suitable for motivating support for political action to address global poverty
Assessing Biofuel Crop Invasiveness: A Case Study
BACKGROUND: There is widespread interest in biofuel crops as a solution to the world's energy needs, particularly in light of concerns over greenhouse-gas emissions. Despite reservations about their adverse environmental impacts, no attempt has been made to quantify actual, relative or potential invasiveness of terrestrial biofuel crops at an appropriate regional or international scale, and their planting continues to be largely unregulated. METHODOLOGY/PRINCIPAL FINDINGS: Using a widely accepted weed risk assessment system, we analyzed a comprehensive list of regionally suitable biofuel crops to show that seventy percent have a high risk of becoming invasive versus one-quarter of non-biofuel plant species and are two to four times more likely to establish wild populations locally or be invasive in Hawaii or in other locations with a similar climate. CONCLUSIONS/SIGNIFICANCE: Because of climatic and ecological similarities, predictions of biofuel crop invasiveness in Hawaii are applicable to other vulnerable island and subtropical ecosystems worldwide. We demonstrate the utility of an accessible and scientifically proven risk assessment protocol that allows users to predict if introduced species will become invasive in their region of interest. Other evidence supports the contention that propagule pressure created by extensive plantings will exacerbate invasions, a scenario expected with large-scale biofuel crop cultivation. Proactive measures, such as risk assessments, should be employed to predict invasion risks, which could then be mitigated via implementation of appropriate planting policies and adoption of the "polluter-pays" principle
Influence of socioeconomic factors on pregnancy outcome in women with structural heart disease
OBJECTIVE: Cardiac disease is the leading cause of indirect maternal mortality. The aim of this study was to analyse to what extent socioeconomic factors influence the outcome of pregnancy in women with heart disease. METHODS: The Registry of Pregnancy and Cardiac disease is a global prospective registry. For this analysis, countries that enrolled ≥10 patients were included. A combined cardiac endpoint included maternal cardiac death, arrhythmia requiring treatment, heart failure, thromboembolic event, aortic dissection, endocarditis, acute coronary syndrome, hospitalisation for cardiac reason or intervention. Associations between patient characteristics, country characteristics (income inequality expressed as Gini coefficient, health expenditure, schooling, gross domestic product, birth rate and hospital beds) and cardiac endpoints were checked in a three-level model (patient-centre-country). RESULTS: A total of 30 countries enrolled 2924 patients from 89 centres. At least one endpoint occurred in 645 women (22.1%). Maternal age, New York Heart Association classification and modified WHO risk classification were associated with the combined endpoint and explained 37% of variance in outcome. Gini coefficient and country-specific birth rate explained an additional 4%. There were large differences between the individual countries, but the need for multilevel modelling to account for these differences disappeared after adjustment for patient characteristics, Gini and country-specific birth rate. CONCLUSION: While there are definite interregional differences in pregnancy outcome in women with cardiac disease, these differences seem to be mainly driven by individual patient characteristics. Adjustment for country characteristics refined the results to a limited extent, but maternal condition seems to be the main determinant of outcome
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