Past, Present and Future of Pharmacovigilance

Directory of Open Access Journals (Sweden)

Derya Kaya

2016-06-01

Full Text Available Pharmacovigilance, is a scientific study related to follow-up problems in drug administrations and identify, record, announce and take due precautions for these problems. Pharmacovigilance works on to increase safety and effectiveness of drugs and minimize the risks associated with drug use. It is significantly developed and continues to improve to satisfy the recent needs. While information spreads like wildfire in the world, there is a need for strategic planning which adopts an integrated approach to go through difficulties caused by increased transmission between borders, easy acceptance of medical product diversity and increased safety expectation of public. We will need dynamic improvement and continuation of pharmacovigilance in all its parts to improve public health and safety. [Archives Medical Review Journal 2016; 25(2.000: 129-139

A situational analysis of pharmacovigilance plans in the Global Fund Malaria and U.S. President's Malaria Initiative proposals.

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Stergachis, Andy; Bartlein, Rebecca J K; Dodoo, Alexander; Nwokike, Jude; Kachur, S Patrick

2010-05-30

Pharmacovigilance programmes can monitor and help ensure the safe use of medicines that are critical to the success of global public health programmes. The widespread deployment of artemisinin-based combination therapy (ACT) by national malaria control programmes as part of the overall Global Malaria Action Plan for malaria control to elimination and eradication makes ACT an excellent candidate for pharmacovigilance activities. In 2008, The Roll Back Malaria partnership issued guidelines for inclusion of pharmacovigilance in Global Fund and other related proposals. In light of this recommendation and the rapid scale-up of ACT worldwide, an analysis of Global Fund Round 8 proposals and the President's Malaria Initiative (PMI) 2009 Malaria Operational Plans was conducted to assess if and how pharmacovigilance has been incorporated into countries' national malaria plans and donor budget requests. The Global Fund-Malaria Round 8 proposals for the 26 countries and the PMI Malaria Operational Plans (MOPs) for fiscal year 2009 for the 15 countries that were approved and received funding from either the Global Fund-Malaria Round 8 or PMI were accessed through the programme websites. The analysis consisted of conducting word counts and key word in context analyses of each proposal and plan. Twelve out of 26 (46%) of the Global Fund proposals mentioned that established pharmacovigilance systems were present in their countries. Four of the fifteen PMI MOPs (27%) mentioned that established pharmacovigilance systems were present in their countries. Only seven of the 26 (27%) Global Fund proposals included a request for funding for new or current pharmacovigilance activities. Seven of 15 (47%) MOPs included a request for funding for pharmacovigilance activities. There were relatively few requests for funding for pharmacovigilance activities, demonstrating a lack of emphasis placed on pharmacovigilance systems in recipient countries. The findings stress the need for more active

Pharmacovigilance Mobile Tool Design in the Field of Arhroplasty.

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Åserød, Hanne; Babic, Ankica

2017-01-01

Pharmacovigilance is an important part of the patient safety and it has a great appeal to physicians. It is concerned with the safety of medical devices and treatments in the light of understanding the risks and dangers based on the already reported safety issues. Internet resources such as the Manufacturer And User Facility Device Experience (MAUDE) web-site are often retrieved due to the lack of internal, local safety databases. The research looked at how Human Computer Interaction could improve user experience. We have designed data entry for safety reporting and pharmacovigilance based on the web-bases system called WebBISS (Web-based implant search system). The expectation is not only to improve usability, but also to stimulate physicians to enter their safety data and become also contributors, and not only users of information. The expert evaluation has been generally positive and encouraged stronger help and error reporting functions. The high fidelity design has given a good impression of the future mobile solution.

Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

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Härmark, Linda; Raine, June; Leufkens, Hubert; Edwards, I Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes

2016-10-01

The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and 'near misses'. Patient-reported safety information leads to a better understanding of the patient's experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals' reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance.

Barriers to the success of an electronic pharmacovigilance reporting system in Kenya: an evaluation three years post implementation.

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Agoro, Oscar O; Kibira, Sarah W; Freeman, Jenny V; Fraser, Hamish S F

2018-06-01

Electronic pharmacovigilance reporting systems are being implemented in many developing countries in an effort to improve reporting rates. This study sought to establish the factors that acted as barriers to the success of an electronic pharmacovigilance reporting system in Kenya 3 years after its implementation. Factors that could act as barriers to using electronic reporting systems were identified in a review of literature and then used to develop a survey questionnaire that was administered to pharmacists working in government hospitals in 6 counties in Kenya. The survey was completed by 103 out of the 115 targeted pharmacists (89.5%) and included free-text comments. The key factors identified as barriers were: unavailable, unreliable, or expensive Internet access; challenges associated with a hybrid system of paper and electronic reporting tools; and system usability issues. Coordination challenges at the national pharmacovigilance center and changes in the structure of health management in the country also had an impact on the success of the electronic reporting system. Different personal, organizational, infrastructural, and reporting system factors affect the success of electronic reporting systems in different ways, depending on the context. Context-specific formative evaluations are useful in establishing the performance of electronic reporting systems to identify problems and ensure that they achieve the desired objectives. While several factors hindered the optimal use of the electronic pharmacovigilance reporting system in Kenya, all were considered modifiable. Effort should be directed toward tackling the identified issues in order to facilitate use and improve pharmacovigilance reporting rates.

Patient-Reported Safety Information : A Renaissance of Pharmacovigilance?

NARCIS (Netherlands)

Härmark, Linda; Raine, June; Leufkens, Bert|info:eu-repo/dai/nl/075255049; Edwards, I Ralph; Moretti, Ugo; Sarinic, Viola Macolic; Kant, Agnes

2016-01-01

The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years

Pharmacovigilance in China: current situation, successes and challenges.

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Zhang, Li; Wong, Lisa Y L; He, Ying; Wong, Ian C K

2014-10-01

With the integration of the global pharmaceutical economy and the gradual transformation of the healthcare insurance system in China, the legislative framework for a comprehensive regulatory system monitoring the whole process including drug development, manufacture, distribution and use has been established by the China Food and Drug Administration (CFDA) to ensure the safety and effectiveness of medication use. China has established a relatively comprehensive pharmacovigilance system covering regulation, organisation and technology from 1989 to 2014. As of 2013, one national centre, 34 provincial centres and more than 400 municipal centres for adverse drug reaction (ADR) monitoring were included in the four-level pharmacovigilance network (national, provincial, municipal and county) with more than 200,000 grassroot organisation users. The China Adverse Drug Reaction Monitoring System (CADRMS) is an online spontaneous reporting system which connects the four-level pharmacovigilance network. By 2013, CADRMS had received over 6.6 million ADR case reports. After integrating and analysing pharmacovigilance data, the National Centre for ADR Monitoring (NCADRM) publishes medication safety information by releasing ADR bulletins, National ADR Annual Reports and International Pharmacovigilance Newsletters. The NCADRM also routinely provides CADRMS data feedback to manufacturers. The CFDA implemented risk management through several approaches, including arranging 'manufacturer communication meetings', modification of medication package inserts, and restriction, suspension or withdrawal of marketing authorisations. Seamless information exchange with overseas regulatory authorities and organisations remains an area for improvement. Further development of the China pharmacovigilance system in terms of signal generation, post-marketing pharmacoepidemiology research and education is also needed.

A review of the National pharmacovigilance system in Malta - implementing and operating a pharmacovigilance management system.

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Tanti, Amy; Micallef, Benjamin; Serracino-Inglott, Anthony; Borg, John-Joseph

2017-01-01

Regulatory authorities have a legal mandate to implement and maintain a Pharmacovigilance System designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Areas covered: This review maps the implementation of pharmacovigilance activities in Malta since accession in the EU in mid 2004 and discusses the challenges the Maltese Regulator encountered while setting up adequate and effective systems to fulfil its legal mandate. Areas reviewed are those around ADR reporting, promotion and safety communications including rapid alerts and recalls, direct healthcare professional communications, risk minimisation measures and safety circulars and quality systems. Expert opinion: Within a ten year period, 3 EU directives on pharmacovigilance were implemented by our agency. Despite limitations to resources, based on a prioritised implementation, the legislation provisions are now fully operational with a good level of sustainability. Lessons learnt from this process are discussed in this review. The coming years will involve strengthening and consolidation of existing processes.

From Pharmacovigilance to Clinical Care Optimization.

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Celi, Leo Anthony; Moseley, Edward; Moses, Christopher; Ryan, Padhraig; Somai, Melek; Stone, David; Tang, Kai-Ou

2014-09-01

In order to ensure the continued, safe administration of pharmaceuticals, particularly those agents that have been recently introduced into the market, there is a need for improved surveillance after product release. This is particularly so because drugs are used by a variety of patients whose particular characteristics may not have been fully captured in the original market approval studies. Even well-conducted, randomized controlled trials are likely to have excluded a large proportion of individuals because of any number of issues. The digitization of medical care, which yields rich and accessible drug data amenable to analytic techniques, provides an opportunity to capture the required information via observational studies. We propose the development of an open, accessible database containing properly de-identified data, to provide the substrate for the required improvement in pharmacovigilance. A range of stakeholders could use this to identify delayed and low-frequency adverse events. Moreover, its power as a research tool could extend to the detection of complex interactions, potential novel uses, and subtle subpopulation effects. This far-reaching potential is demonstrated by our experience with the open Multi-parameter Intelligent Monitoring in Intensive Care (MIMIC) intensive care unit database. The new database could also inform the development of objective, robust clinical practice guidelines. Careful systematization and deliberate standardization of a fully digitized pharmacovigilance process is likely to save both time and resources for healthcare in general.

Pharmacovigilance: Boon for the safety and efficacy of Ayuvedic formulations

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Chaudhary, Anand; Singh, Neetu; Kumar, Neeraj

2010-01-01

Pharmacovigilance is a corrective process originating in pharmaco-epidemiology. The 1997 Erice Declaration, presented at the World Health Organisation, became the basis on which the concept was implemented internationally for conventional systems of medicine. The increasing international acceptance of Ayurveda, led regulators to implement a similar program for Ayurveda, particularly as some medical professionals, scientists and members of the public reported adverse reactions after taking Ayurvedic formulations. The World Health Organisation therefore persuaded the Department of AYUSH, Ministry of Health and Family Welfare, Government of India, to implement a pharmacovigilance program for Ayurveda, as a means to ensuring the safety and efficacy of Ayurvedic medicines. After a year of due diligence, the pharmacovigilance program was launched nationally on 29 September 2008. Since that time, Ayurveda, Siddha and Unani medicines have been monitored according to the provisions of a protocol prepared by the National Pharmacovigilance Resource Centre, IPGTRA, Jamnagar, and approved by Department of AYUSH. The program was reviewed, first, on 21st January 2009 by the National Pharmaco-vigilance Consultative Committee for ASU drugs (NPCC-ASU), and again, on 15 Feburary, 2010, when an evaluation meeting effectively rubber stamped the program. Among the outcomes of these meetings were several suggestions of measures to improve the program’s efficiency. Recent developments include the constitution of pharmacovigilance centers at all Ayurveda Teaching institutes and research centers. PMID:21731371

A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia.

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Aljadhey, Hisham; Mahmoud, Mansour A; Alshammari, Thamir M; Al-Dhaeefi, Mohammed; Le Louet, Herve; Perez-Gutthann, Susana; Pitts, Peter J

2015-09-01

To explore the challenges facing pharmacovigilance in Saudi Arabia and formulate recommendations to improve it from the perspective of healthcare professionals in Saudi Arabia. This was a qualitative study of 4 focus group discussions with pharmacists, physicians, and academicians held under the auspices of the King Saud University School of Pharmacy and the Center for Medicine in the Public Interest, Riyadh, Saudi Arabia. A total of 29 eligible healthcare professionals were invited to participate in the discussion. The predefined themes of the study were the current practice and major challenges facing pharmacovigilance in regulatory bodies, hospitals, the community, and academia, as well as recommendations to improve pharmacovigilance practice.  Of the 29 participants invited, 27 attended the discussion. Challenges facing regulatory bodies included complicated adverse drug reactions (ADR) reporting forms, lack of feedback on ADRs submitted to the Saudi Food and Drug Authority, lack of decisions from the local authority to withdraw medications, and lack of data on pharmacovigilance. The challenges to pharmacovigilance in hospitals included the lack of knowledge of the significance of ADR reporting, workload, blaming culture, and lack of collaboration between regulatory bodies and hospitals. However, challenges facing pharmaceutical industries included the lack of drug manufacturers in Saudi Arabia and lack of interest in pharmacovigilance. Recommendations to improve pharmacovigilance included the need for communication, stronger regulatory requirements, the need for research, the need for unified ADRs reporting, and continuous education and training.  The study has identified the challenges facing pharmacovigilance in Saudi Arabia and made certain recommendations to overcome them. These recommendations might be helpful for regulatory bodies to enhance spontaneous reporting and promote pharmacovigilance.

Managing the interface with marketing to improve delivery of pharmacovigilance within the pharmaceutical industry.

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Edwards, Brian

2004-01-01

The pharmaceutical industry is under pressure to improve the scientific quality of its decisions concerning the benefit and risks of its products while ensuring compliance with acceptable standards of marketing. All those in a pharmaceutical company who currently work within pharmacovigilance should be encouraged to lead from the front to examine ongoing marketing activities to see how they can be adapted more towards pharmacovigilance and risk management. The current irony is that the personnel who have the greatest influence on benefit-risk decisions of a product are not necessarily those who acknowledge that they are performing pharmacovigilance. Indeed, for all concerned, whether their orientation is scientific and commercial, effective communication with prescribers and consumers usually underpins product success. Also, a substantial 'marketing' budget is culturally acceptable for the pharmaceutical industry so it is logical to assume that resource for postmarketing activity is often made available. Given these realities, I suggest we should strive for an integrated marketing and risk-management plan based on the best available evidence and that being fully aware and in control of the safety issues for your products is the best way to commercialise them successfully. This approach can still be consistent with other corporate responsibilities such as trying to reduce the financial burden of product development. If this article stimulates further debate about how the pharmaceutical industry can more effectively organise resources and operations to support pharmacovigilance, risk management, and marketing, then it will have achieved its purpose.

Patient-centered pharmacovigilance: A review

African Journals Online (AJOL)

centered pharmacovigilance ... (DOAJ), African Journal Online, Bioline International, Open-J-Gate and Pharmacy Abstracts .... claimed a relationship between duration of drug usage and ..... prescribed physicians were completely safe, and.

Pharmacovigilance in Intensive Care Unit - An Overview

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Bimla Sharma

2008-01-01

Full Text Available The drug related complications are on the rise warranting special attention towards patient safety in Intensive Care Unit (ICU setup. Pharmacovigilance is the science about the detection, assessment and prevention of drug related problems. This review is aimed to highlight significant problems arising from medication errors with emphasis on special drugs used in ICU (oxygen, antibiotics, sedatives, analgesics and neuromuscular blocking drugs and their risk reduction strategies in ICU utilizing practice of pharmacovigilance. Human error, lack of communication among various health providers, inadequate knowledge about drugs, failure to follow protocols or recommended guidelines are important causes of drug related problems in ICU. It is imperative that ICU administrators and medical directors of hospitals consider adverse drug events (ADEs as system failures. Pharmacovigilance, an observational science is the need of the hour for patients admitted in ICUs. We need to give more emphasis on prevention rather than treating the potentially fatal complications arising from ADEs. Eternal vigilance is the key. Protocol based management, improvement of medication system, frequent audits, improved communication, good team work, a blame free environ-ment, inclusion of a pharmacist, leadership involvement and use of information technology in the ICU are possible solutions.

False-positive results in pharmacoepidemiology and pharmacovigilance.

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Bezin, Julien; Bosco-Levy, Pauline; Pariente, Antoine

2017-09-01

False-positive constitute an important issue in scientific research. In the domain of drug evaluation, it affects all phases of drug development and assessment, from the very early preclinical studies to the late post-marketing evaluations. The core concern associated with this false-positive is the lack of replicability of the results. Aside from fraud or misconducts, false-positive is often envisioned from the statistical angle, which considers them as a price to pay for type I error in statistical testing, and its inflation in the context of multiple testing. If envisioning this problematic in the context of pharmacoepidemiology and pharmacovigilance however, that both evaluate drugs in an observational settings, information brought by statistical testing and the significance of such should only be considered as additional to the estimates provided and their confidence interval, in a context where differences have to be a clinically meaningful upon everything, and the results appear robust to the biases likely to have affected the studies. In the following article, we consequently illustrate these biases and their consequences in generating false-positive results, through studies and associations between drug use and health outcomes that have been widely disputed. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works.

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Santoro, Aniello; Genov, Georgy; Spooner, Almath; Raine, June; Arlett, Peter

2017-10-01

This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assessing all aspects of the risk management of medicinal products, thus ensuring that medicines approved for the European Union market are optimally used by maximising their benefits and minimising risks. The main objectives of the system are to promote and protect public health by supporting the availability of medicines including those that fulfil previously unmet medical needs, and reducing the burden of adverse drug reactions. These are achieved through a proactive, risk proportionate and patient-centred approach, with high levels of transparency and engagement of civil society. In the European Union, pharmacovigilance is now fully integrated into the life cycle of medicinal products, with the planning of pharmacovigilance activities commencing before a medicine is placed on the market, and companies encouraged to start planning very early in development for high-innovation products. After authorisation, information on the safety of medicines continues to be obtained through a variety of sources, including spontaneous reports of adverse drug reactions or monitoring real-world data. Finally, the measurement of the impact of pharmacovigilance activities, auditing and inspections, as well as capacity building ensure that the system undergoes continuous improvement and can always rely on the best methodologies to safeguard public health.

A global view of undergraduate education in pharmacovigilance.

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Hartman, Jenny; Härmark, Linda; van Puijenbroek, Eugène

2017-07-01

The aim of this study was to gain insight in current pharmacovigilance educational activities and to gather information on which topics should be included in the undergraduate pharmacovigilance core curriculum. A web-based questionnaire was carried out containing 45 questions divided over four sections between 28 October 2014 and 31 January 2015. Potential participants working in pharmacovigilance and/or providing training in this field were invited via email and a widespread web link and snowball sampling was used to recruit additional participants. The questionnaire was filled out by 307 respondents from 88 different countries with a response rate of 29.3% for the email invitation and an unknown rate for the web link. Respondents were mainly pharmacists and physicians. Currently, lectures are the largest proportion of educational activities and all healthcare profession curricula have a mode of 2 h as number of contact hours per course. Respondents rated clinical aspects as the most important subdomain to be included in the core curriculum with prevention of adverse drug reactions as the most important subtopic. This was followed by communication aspects between parties, with communication between regulatory authorities and healthcare professionals, methodological aspects with causality assessment, and regulatory aspects with benefit-risk assessment. This is similar to subjects addressed in current educational activities with little difference between medical and pharmacy curricula. This study gave a good general impression in current educational activities and the respondents' needs and wishes for future activities worldwide, which both will be used for the development of the undergraduate pharmacovigilance core curriculum.

Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives

Directory of Open Access Journals (Sweden)

Zhengwu Lu

2009-10-01

Full Text Available Zhengwu LuClinical Research Department, Abbott Vascular, Santa Clara, CA, USAAbstract: Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product’s risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.Keywords: information technology, pharmacovigilance, safety, standard, risk management, adverse event

Pharmacovigilance: the devastating consequences of not thinking ...

African Journals Online (AJOL)

Pharmacovigilance: the devastating consequences of not thinking about adverse drug reactions: The burden of adverse drug reactions (ADRs) on patient care has been found to be high globally and is particularly high in South Africa.

A day in the life of a pharmacovigilance case processor.

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Bhangale, Ritesh; Vaity, Sayali; Kulkarni, Niranjan

2017-01-01

Pharmacovigilance (PV) has grown significantly in India in the last couple of decades. The etymological roots for the word "pharmacovigilance" are "Pharmakon" (Greek for drug) and "Vigilare" (Latin for to keep watch). It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

The Internet and drug safety: what are the implications for pharmacovigilance?

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Cobert, B; Silvey, J

1999-02-01

directly on line using an electronic version of its MedWatch form. It is expected that these developments will change the nature of the way pharmacovigilance is carried out. Significant issues will arise from this including privacy concerns. The European Union's 1995 directive on 'the protection of individuals with regard to the processing of personal data and on the free movement of such data (95/46/EC)' went into effect in October 1998. The enabling legislation now being passed by the member states will produce significant changes in the way companies and governments handle individual patient data in order to assure the privacy and protection of individuals.

75 FR 65293 - Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for...

Science.gov (United States)

2010-10-22

...] Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for... Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data...

Modern Approaches to Continuous Audit in the Pharmacovigilance System Vinnytsia region: the Results of 2016

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Fedir Hladkykh

2017-12-01

Full Text Available The results of the pharmacovigilance system operation in Vinnytsia region during 2016 are presented based on the data of the electronic online system "Pharmacovigilance-2016", which was first introduced by us on the basis of the table editor Microsoft Excel of the file-hosting system Google Drive. The formula for calculating the efficiency of the pharmacovigilance implementation as an integral assessment of the safety oversight of medical devices in their use in Vinnytsia region during 2016 is proposed, taking into account the capacity of health facilities at the local level.

Pharmacovigilance: Tiens Slimming Tea Causes Increased Blood ...

African Journals Online (AJOL)

... possible link between the constituents of the slimming tea and increased blood pressure and also provide evidence of other possible harmful effects that may occur with the use of the slimming tea. Keywords: Pharmacovigilance, hypertension, slimming tea. West African Journal of Pharmacology and Drug Research Vol.

Are we pharmacovigilant enough in ophthalmic practice?

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Ashok Dubey

2013-01-01

Full Text Available No drug is absolutely safe. Pharmacovigilance is the science related to detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. The ocular medications and devices can cause localized and systemic adverse effects. Not all adverse effects are known when a drug or device is launched in market because of limitations of clinical trials. Many adverse effects are recognized due to the spontaneous reporting of the vigilant doctors who observe and report such events encountered in their practice. Despite a large ophthalmic patient population base, India does not have robust adverse drug reaction (ADR database because of lack of reporting culture. Government of India recently launched the Pharmacovigilance Programme of India (PvPI to monitor ADRs and create awareness among the healthcare professionals about the importance of ADRs. Suspecting and reporting a possible drug reaction is very important in developing a safe and rational ophthalmic practice.

Vaccine Pharmacovigilance: Adverse Effects Reported and the ...

African Journals Online (AJOL)

Routine utilization of vaccines during immunization in children is a tool in the reduction of childhood morbidity and mortality of infectious disease globally. This requires pharmacovigilance to ensure safety among the category of patients. Due to the exposure of new born to vaccine at birth, it became necessary to assess the ...

Sequence symmetry analysis in pharmacovigilance and pharmacoepidemiologic studies

DEFF Research Database (Denmark)

Lai, Edward Chia Cheng; Pratt, Nicole; Hsieh, Cheng Yang

2017-01-01

Sequence symmetry analysis (SSA) is a method for detecting adverse drug events by utilizing computerized claims data. The method has been increasingly used to investigate safety concerns of medications and as a pharmacovigilance tool to identify unsuspected side effects. Validation studies have i...

The importance of intra-hospital pharmacovigilance in the detection of medication errors

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Villegas, Francisco; Figueroa-Montero, David; Barbero-Becerra, Varenka; Juárez-Hernández, Eva; Uribe, Misael; Chávez-Tapia, Norberto; González-Chon, Octavio

2018-01-01

Hospitalized patients are susceptible to medication errors, which represent between the fourth and the sixth cause of death. The department of intra-hospital pharmacovigilance intervenes in the entire process of medication with the purpose to prevent, repair and assess damages. To analyze medication errors reported by Mexican Fundación Clínica Médica Sur pharmacovigilance system and their impact on patients. Prospective study carried out from 2012 to 2015, where medication prescriptions given to patients were recorded. Owing to heterogeneity, data were described as absolute numbers in a logarithmic scale. 292 932 prescriptions of 56 368 patients were analyzed, and 8.9% of medication errors were identified. The treating physician was responsible of 83.32% of medication errors, residents of 6.71% and interns of 0.09%. No error caused permanent damage or death. This is the pharmacovigilance study with the largest sample size reported. Copyright: © 2018 SecretarÍa de Salud.

Detecting medication errors in the New Zealand pharmacovigilance database: a retrospective analysis.

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Kunac, Desireé L; Tatley, Michael V

2011-01-01

Despite the traditional focus being adverse drug reactions (ADRs), pharmacovigilance centres have recently been identified as a potentially rich and important source of medication error data. To identify medication errors in the New Zealand Pharmacovigilance database (Centre for Adverse Reactions Monitoring [CARM]), and to describe the frequency and characteristics of these events. A retrospective analysis of the CARM pharmacovigilance database operated by the New Zealand Pharmacovigilance Centre was undertaken for the year 1 January-31 December 2007. All reports, excluding those relating to vaccines, clinical trials and pharmaceutical company reports, underwent a preventability assessment using predetermined criteria. Those events deemed preventable were subsequently classified to identify the degree of patient harm, type of error, stage of medication use process where the error occurred and origin of the error. A total of 1412 reports met the inclusion criteria and were reviewed, of which 4.3% (61/1412) were deemed preventable. Not all errors resulted in patient harm: 29.5% (18/61) were 'no harm' errors but 65.5% (40/61) of errors were deemed to have been associated with some degree of patient harm (preventable adverse drug events [ADEs]). For 5.0% (3/61) of events, the degree of patient harm was unable to be determined as the patient outcome was unknown. The majority of preventable ADEs (62.5% [25/40]) occurred in adults aged 65 years and older. The medication classes most involved in preventable ADEs were antibacterials for systemic use and anti-inflammatory agents, with gastrointestinal and respiratory system disorders the most common adverse events reported. For both preventable ADEs and 'no harm' events, most errors were incorrect dose and drug therapy monitoring problems consisting of failures in detection of significant drug interactions, past allergies or lack of necessary clinical monitoring. Preventable events were mostly related to the prescribing and

Linking NHS data for pediatric pharmacovigilance: Results of a Delphi survey.

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Hopf, Y M; Francis, J; Helms, P J; Haughney, J; Bond, C

2016-01-01

be acceptable to stakeholders to introduce a data linkage system for pharmacovigilance as long as identified concerns are addressed. Concerns included adherence to current professional, legal and ethical standards, as well resolving practical issues. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Pharmacovigilance in Crisis: Drug Safety at a Crossroads.

Science.gov (United States)

Price, John

2018-05-01

Pharmacovigilance (PV) is under unprecedented stress from fundamental changes in a booming pharmaceutical industry, from the challenges of creating and maintaining an increasingly complex PV system in a globally diverse regulatory environment, and from unpredicted consequences of historical PV cost-reduction strategies. At the same time, talent availability lags demand, and many PV professionals may no longer be finding personal fulfillment in their careers. The situation creates risks for companies. Advantages and disadvantages of potential strategies to address this increasing problem at a corporate and industry level and in collaboration with regulatory agencies are discussed, as well as opportunities to adopt new technologies, including artificial intelligence and machine-learning to automate pharmacovigilance operations. These approaches would address burdensome and wasteful effort assuring regulatory compliance and free up resources to support the original mission of PV as an important public health activity and to reinvest in the development of new drugs. Copyright © 2018 Elsevier HS Journals, Inc. All rights reserved.

Linked health data for pharmacovigilance in children: perceived legal and ethical issues for stakeholders and data guardians.

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Hopf, Yvonne Marina; Bond, Christine B; Francis, Jill J; Haughney, John; Helms, Peter J

2014-02-12

The inclusion of the Community Health Index in the recording of National Health Service (NHS) contacts in Scotland facilitates national linkage of data such as prescribing and healthcare utilisation. This linkage could be the basis for identification of adverse drug reactions. The aim of this article is to report the views of healthcare professionals on data sharing, ownership and the legal and other applicable frameworks relevant to linkage of routinely collected paediatric healthcare data. Qualitative study using semistructured face-to-face interviews addressing the study aims. Purposive sample of professional stakeholders (n=25) including experts on ethics, data protection, pharmacovigilance, data linkage, legal issues and prescribing. Interviews were audio-recorded, transcribed and thematically analysed using a framework approach. Participants identified existing data sharing systems in the UK. Access to healthcare data should be approved by the data owners. The definition of data ownership and associated legal responsibilities for linked healthcare data were seen as important factors to ensure accountability for the use of linked data. Yet data owners were seen as facilitators of the proposed data linkage. Twelve frameworks (legal, regulatory and governance) applicable to the linkage of healthcare data were identified. A large number of potentially relevant legal and regulatory frameworks were identified. Ownership of the linked data was seen as an extension of responsibility for, or guardianship of, the source datasets. The consensus emerging from the present study was that clarity is required on the definition of data sharing, data ownership and responsibilities of data owners.

Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives.

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Lu, Zhengwu

2009-01-01

Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

Knowledge and attitude of health-care professionals in hospitals towards pharmacovigilance in Saudi Arabia.

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Alshammari, Thamir M; Alamri, Khaled K; Ghawa, Yazeed A; Alohali, Noura F; Abualkol, Shaza A; Aljadhey, Hisham S

2015-12-01

Drug safety has major implications for patients' lives. However, this concept is still considered new to some healthcare professionals. This study aims to investigate the knowledge and awareness of Saudi healthcare professionals to pharmacovigilance (PV). Setting Governmental and private hospitals at three main cities in Saudi Arabia (Riyadh, Jeddah, and Dammam). A cross-sectional survey among healthcare professionals (pharmacists, physicians, and nurses) within 12 Saudi hospitals was conducted between November and December 2012. The questionnaire consisted of 18 questions assessing the knowledge, awareness, and attitude of healthcare professionals (HCPs) towards science and the concept of PV. Descriptive statistics were used to analyze the data. The data were analyzed using Statistical Analysis Software (SAS 9.3). Main outcome measure Knowledge, attitude and practice of HCPs toward pharmacovigilance. Three-hundred and thirty-two healthcare professionals completed the survey (response rate 72 %), 110 (34 %) physicians, 106 (33 %) pharmacists, and 104 (32 %) nurses. More than half of the participants (55 %) did not know the correct definition of PV. Two-thirds of the respondents, 207 (65.5 %), had knowledge of the aim of post-marketing surveillance, yet only 113 (36.9 %) were aware that the National Pharmacovigilance and Drug Safety Center is the official body for monitoring adverse drug reaction in Saudi Arabia. In addition, 34.7 % agreed that lack of time could be a major barrier for reporting. The majority of the respondents (78.4 %) believed that reporting was a professional obligation and hospitals should have a drug safety department. There was a limited knowledge of pharmacovigilance that could have affected reporting incidence. Educational intervention and a practical training program need to be applied by the drug regulatory body as well as health authorities to enhance the pharmacovigilance and drug safety culture in Saudi Arabia.

The Adverse Drug Reactions from Patient Reports in Social Media Project: Five Major Challenges to Overcome to Operationalize Analysis and Efficiently Support Pharmacovigilance Process.

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Bousquet, Cedric; Dahamna, Badisse; Guillemin-Lanne, Sylvie; Darmoni, Stefan J; Faviez, Carole; Huot, Charles; Katsahian, Sandrine; Leroux, Vincent; Pereira, Suzanne; Richard, Christophe; Schück, Stéphane; Souvignet, Julien; Lillo-Le Louët, Agnès; Texier, Nathalie

2017-09-21

Adverse drug reactions (ADRs) are an important cause of morbidity and mortality. Classical Pharmacovigilance process is limited by underreporting which justifies the current interest in new knowledge sources such as social media. The Adverse Drug Reactions from Patient Reports in Social Media (ADR-PRISM) project aims to extract ADRs reported by patients in these media. We identified 5 major challenges to overcome to operationalize the analysis of patient posts: (1) variable quality of information on social media, (2) guarantee of data privacy, (3) response to pharmacovigilance expert expectations, (4) identification of relevant information within Web pages, and (5) robust and evolutive architecture. This article aims to describe the current state of advancement of the ADR-PRISM project by focusing on the solutions we have chosen to address these 5 major challenges. In this article, we propose methods and describe the advancement of this project on several aspects: (1) a quality driven approach for selecting relevant social media for the extraction of knowledge on potential ADRs, (2) an assessment of ethical issues and French regulation for the analysis of data on social media, (3) an analysis of pharmacovigilance expert requirements when reviewing patient posts on the Internet, (4) an extraction method based on natural language processing, pattern based matching, and selection of relevant medical concepts in reference terminologies, and (5) specifications of a component-based architecture for the monitoring system. Considering the 5 major challenges, we (1) selected a set of 21 validated criteria for selecting social media to support the extraction of potential ADRs, (2) proposed solutions to guarantee data privacy of patients posting on Internet, (3) took into account pharmacovigilance expert requirements with use case diagrams and scenarios, (4) built domain-specific knowledge resources embeding a lexicon, morphological rules, context rules, semantic rules

The value of patient reporting to the pharmacovigilance system: a systematic review.

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Inácio, Pedro; Cavaco, Afonso; Airaksinen, Marja

2017-02-01

Current trends in pharmacovigilance systems are veering towards patient involvement in spontaneous reporting of adverse drug reactions (ADRs). The aim of the current systematic review was to identify what is known and what remains unknown with respect to patient reporting to pharmacovigilance systems. A systematic literature search was conducted in PubMed, CINAHL, Journals@Ovid and the Cochrane Library. Studies were included if they contained: (i) reviews about patient reporting; (ii) evaluation of patient reports to national or supranational pharmacovigilance authorities; (iii) a comparison between patient and healthcare professional (HCP) reports submitted to pharmacovigilance authorities; and (iv) surveys of patient experiences, opinions and awareness about reporting ADRs. The methodological quality of the studies was assessed according to principles of Grading of Recommendations, Assessment, Development and Evaluations (GRADE). A total of thirty four studies were included. Five of the studies were reviews (two of which systematic reviews), fourteen retrospective observational studies, nine surveys and six applied mixed research methods. Patient reporting has the advantages of bringing novel information about ADRs. It provides a more detailed description of ADRs, and reports about different drugs and system organ classes when compared with HCP reporting. In addition, patients describe the severity and impact of ADRs on daily life, complementing information derived from HCPs. Patient reporting is relatively rare in most countries. Patient reporting adds new information, and perspective about ADRs in a way otherwise unavailable. This can contribute to better decision-making processes in regulatory activities. The present review identified gaps in knowledge that should be addressed to improve our understanding of the full potential and drawbacks of patient reporting. © 2016 The British Pharmacological Society.

Analysis of Patient Narratives in Disease Blogs on the Internet: An Exploratory Study of Social Pharmacovigilance.

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Matsuda, Shinichi; Aoki, Kotonari; Tomizawa, Shiho; Sone, Masayoshi; Tanaka, Riwa; Kuriki, Hiroshi; Takahashi, Yoichiro

2017-02-24

Although several reports have suggested that patient-generated data from Internet sources could be used to improve drug safety and pharmacovigilance, few studies have identified such data sources in Japan. We introduce a unique Japanese data source: tōbyōki, which translates literally as "an account of a struggle with disease." The objective of this study was to evaluate the basic characteristics of the TOBYO database, a collection of tōbyōki blogs on the Internet, and discuss potential applications for pharmacovigilance. We analyzed the overall gender and age distribution of the patient-generated TOBYO database and compared this with other external databases generated by health care professionals. For detailed analysis, we prepared separate datasets for blogs written by patients with depression and blogs written by patients with rheumatoid arthritis (RA), because these conditions were expected to entail subjective patient symptoms such as discomfort, insomnia, and pain. Frequently appearing medical terms were counted, and their variations were compared with those in an external adverse drug reaction (ADR) reporting database. Frequently appearing words regarding patients with depression and patients with RA were visualized using word clouds and word cooccurrence networks. As of June 4, 2016, the TOBYO database comprised 54,010 blogs representing 1405 disorders. Overall, more entries were written by female bloggers (68.8%) than by male bloggers (30.8%). The most frequently observed disorders were breast cancer (4983 blogs), depression (3556), infertility (2430), RA (1118), and panic disorder (1090). Comparison of medical terms observed in tōbyōki blogs with those in an external ADR reporting database showed that subjective and symptomatic events and general terms tended to be frequently observed in tōbyōki blogs (eg, anxiety, headache, and pain), whereas events using more technical medical terms (eg, syndrome and abnormal laboratory test result) tended to be

Pharmacist's knowledge, practice and attitudes toward pharmacovigilance and adverse drug reactions reporting process.

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Suyagh, Maysa; Farah, Doaa; Abu Farha, Rana

2015-04-01

Adverse drug reactions (ADRs) are a major cause of drug related morbidity and mortality. Pharmacovigilance is the science that plays an essential role in the reduction of ADRs, thus the evolution and growth of this science are critical for effective and safe clinical practice. This study is considered the first study in the region to evaluate pharmacist's knowledge, practice and attitudes toward ADRs reporting after establishing the national ADRs reporting center in Jordan. A cross sectional study was used to evaluate pharmacist knowledge and attitude toward ADRs reporting. A structured validated questionnaire was developed for this purpose and a total of 208 pharmacists were recruited to participate in this study. The majority of pharmacists have insufficient awareness and lack of knowledge about pharmacovigilance and ADRs reporting. Also the rate of reporting of ADRs was extremely poor. Several factors were found to discourage pharmacists from reporting ADRs, which include inadequate information available from the patient, unavailability of pharmacist ADRs form when needed, unawareness of the existence of the national ADRs reporting system. Also pharmacists think that ADRs are unimportant or they did not know how to report them. The results of this study suggest that pharmacists have insufficient knowledge about the concept of pharmacovigilance and spontaneous ADRs reporting. On the other hand, pharmacists had positive attitudes toward pharmacovigilance, despite their little experience with ADRs reporting. Educational programs are needed to increase pharmacist's role in the reporting process, and thus to have a positive impact on the overall patient caring process.

The EU-ADR Web Platform: delivering advanced pharmacovigilance tools.

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Oliveira, José Luis; Lopes, Pedro; Nunes, Tiago; Campos, David; Boyer, Scott; Ahlberg, Ernst; van Mulligen, Erik M; Kors, Jan A; Singh, Bharat; Furlong, Laura I; Sanz, Ferran; Bauer-Mehren, Anna; Carrascosa, Maria C; Mestres, Jordi; Avillach, Paul; Diallo, Gayo; Díaz Acedo, Carlos; van der Lei, Johan

2013-05-01

Pharmacovigilance methods have advanced greatly during the last decades, making post-market drug assessment an essential drug evaluation component. These methods mainly rely on the use of spontaneous reporting systems and health information databases to collect expertise from huge amounts of real-world reports. The EU-ADR Web Platform was built to further facilitate accessing, monitoring and exploring these data, enabling an in-depth analysis of adverse drug reactions risks. The EU-ADR Web Platform exploits the wealth of data collected within a large-scale European initiative, the EU-ADR project. Millions of electronic health records, provided by national health agencies, are mined for specific drug events, which are correlated with literature, protein and pathway data, resulting in a rich drug-event dataset. Next, advanced distributed computing methods are tailored to coordinate the execution of data-mining and statistical analysis tasks. This permits obtaining a ranked drug-event list, removing spurious entries and highlighting relationships with high risk potential. The EU-ADR Web Platform is an open workspace for the integrated analysis of pharmacovigilance datasets. Using this software, researchers can access a variety of tools provided by distinct partners in a single centralized environment. Besides performing standalone drug-event assessments, they can also control the pipeline for an improved batch analysis of custom datasets. Drug-event pairs can be substantiated and statistically analysed within the platform's innovative working environment. A pioneering workspace that helps in explaining the biological path of adverse drug reactions was developed within the EU-ADR project consortium. This tool, targeted at the pharmacovigilance community, is available online at https://bioinformatics.ua.pt/euadr/. Copyright © 2012 John Wiley & Sons, Ltd.

Pharmacovigilance training for specialist oncology nurses-a two way evaluation

NARCIS (Netherlands)

Schutte, T.; Van Eekeren, R.; Richir, M.; Van Staveren, J.; Van Puijenbroek, E.P.; Tichelaar, J.; Van Agtmael, M.A.

2017-01-01

Background: In a new prescribing qualifcation course for specialist oncology nurses, we thought it important to emphasize pharma-covigilance and adverse drug reaction (ADR)-reporting. To this end, our aim was to develop and evaluate an ADR reporting assignment for specialist oncology nurses.

Pharmacoenvironmentology – a component of pharmacovigilance

Directory of Open Access Journals (Sweden)

Gupta Varun

2007-07-01

Full Text Available Abstract According to WHO, Pharmacovigilance activities are done to monitor detection, assessment, understanding and prevention of any obnoxious adverse reactions to drugs at therapeutic concentration on animal and human beings. However, there is also a growing focus among scientists and environmentalists about the impact of drugs on environment and surroundings. The existing term 'Ecopharmacology' is too broad and not even defined in a clear manner. The term 'Pharmacoenvironmentology' seeks to deal with the environmental impact of drugs given to humans and animals at therapeutic doses.

Consumer adverse drug reaction reporting - A new step in pharmacovigilance?

NARCIS (Netherlands)

van Grootheest, K; de Graaf, L; de Jong-van den Berg, LTW

2003-01-01

The direct reporting of adverse drug reactions by patients is becoming an increasingly important topic for discussion in the world of pharmacovigilance. At this time, few countries accept consumer reports. We present an overview of experiences with consumer reporting in various countries of the

Advances in pharmacovigilance initiatives surrounding antimicrobial resistance-Indian perspective.

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Bairy, Laxminarayana Kurady; Nayak, Veena; A, Avinash; Kunder, Sushil Kiran

2016-08-01

In recent years the development of antimicrobial resistance has been accelerating, the discovery of new antimicrobial agents has slowed substantially in past decades. This review mainly focuses on the problem of antimicrobial resistance(AMR); the various contributor mechanisms, consequences and future of AMR. The review also highlights the irrational use of antimicrobials, improving their usage and problems associated with pharmacovigilance of antimicrobial resistance. Pharmacovigilance in the form of surveillance of antibiotic use is being done in 90% of the countries worldwide through the WHONET program developed by WHO. However, the data comes from a limited area of the globe. Data from every part of the world is required, so that there is geographical representation of every region. A major hurdle in quantifying the extent of antimicrobial resistance is the fact that there are several known microbes, that may turn out to be resistant to one or more of the several known antimicrobial agents. The global action plan initiated by WHO, if implemented successfully will definitely reduce AMR and will help in evaluating treatment interventions.

A Pharmacovigilance Study in First Episode of Psychosis: Psychopharmacological Interventions and Safety Profiles in the PEPs Project.

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Bioque, Miquel; Llerena, Adrián; Cabrera, Bibiana; Mezquida, Gisela; Lobo, Antonio; González-Pinto, Ana; Díaz-Caneja, Covadonga M; Corripio, Iluminada; Aguilar, Eduardo J; Bulbena, Antoni; Castro-Fornieles, Josefina; Vieta, Eduard; Lafuente, Amàlia; Mas, Sergi; Parellada, Mara; Saiz-Ruiz, Jerónimo; Cuesta, Manuel J; Bernardo, Miguel

2016-04-01

The characterization of the first episode of psychosis and how it should be treated are principal issues in actual research. Realistic, naturalistic studies are necessary to represent the entire population of first episode of psychosis attended in daily practice. Sixteen participating centers from the PEPs project recruited 335 first episode of psychosis patients, aged 7 to 35 years. This article describes and discusses the psychopharmacological interventions and safety profiles at baseline and during a 60-day pharmacovigilance period. The majority of first episode of psychosis patients received a second-generation antipsychotic (96.3%), orally (95%), and in adjusted doses according to the product specifications (87.2%). A total of 24% were receiving an antipsychotic polytherapy pattern at baseline, frequently associated with lower or higher doses of antipsychotics than the recommended ones. Eight patients were taking clozapine, all in monotherapy. Males received higher doses of antipsychotic (P=.043). A total of 5.2% of the patients were being treated with long-acting injectable antipsychotics; 12.2% of the patients received anticholinergic drugs, 12.2% antidepressants, and 13.7% mood stabilizers, while almost 40% received benzodiazepines; and 35.52% reported at least one adverse drug reaction during the pharmacovigilance period, more frequently associated with higher antipsychotic doses and antipsychotic polytherapy (85.2% vs 45.5%, Psecurity issues, support future research of determinate pharmacological strategies for the treatment of early phases of psychosis, such as the role of clozapine, long-acting injectable antipsychotics, antipsychotic combination, and the use of benzodiazepines. © The Author 2015. Published by Oxford University Press on behalf of CINP.

Pharmacovigilance and drug safety 2011 in Calabria (Italy: Adverse events analysis

Directory of Open Access Journals (Sweden)

Francesca Scicchitano

2012-01-01

Full Text Available Background : Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs. The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. Materials and Methods: We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field. Results : Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100 in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %. Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%. There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it, and there is a strong interest in participating to training courses in the field (95% are interested. Conclusions : Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.

Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis.

Science.gov (United States)

Scicchitano, Francesca; Giofrè, Chiara; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; De Fazio, Salvatore; Menniti, Michele; Curia, Rubens; Arena, Concetta; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2012-09-01

Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs). The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco) is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field. Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100) in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %). Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%). There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it), and there is a strong interest in participating to training courses in the field (95% are interested). Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.

Early detection of pharmacovigilance signals with automated methods based on false discovery rates: a comparative study.

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Ahmed, Ismaïl; Thiessard, Frantz; Miremont-Salamé, Ghada; Haramburu, Françoise; Kreft-Jais, Carmen; Bégaud, Bernard; Tubert-Bitter, Pascale

2012-06-01

Improving the detection of drug safety signals has led several pharmacovigilance regulatory agencies to incorporate automated quantitative methods into their spontaneous reporting management systems. The three largest worldwide pharmacovigilance databases are routinely screened by the lower bound of the 95% confidence interval of proportional reporting ratio (PRR₀₂.₅), the 2.5% quantile of the Information Component (IC₀₂.₅) or the 5% quantile of the Gamma Poisson Shrinker (GPS₀₅). More recently, Bayesian and non-Bayesian False Discovery Rate (FDR)-based methods were proposed that address the arbitrariness of thresholds and allow for a built-in estimate of the FDR. These methods were also shown through simulation studies to be interesting alternatives to the currently used methods. The objective of this work was twofold. Based on an extensive retrospective study, we compared PRR₀₂.₅, GPS₀₅ and IC₀₂.₅ with two FDR-based methods derived from the Fisher's exact test and the GPS model (GPS(pH0) [posterior probability of the null hypothesis H₀ calculated from the Gamma Poisson Shrinker model]). Secondly, restricting the analysis to GPS(pH0), we aimed to evaluate the added value of using automated signal detection tools compared with 'traditional' methods, i.e. non-automated surveillance operated by pharmacovigilance experts. The analysis was performed sequentially, i.e. every month, and retrospectively on the whole French pharmacovigilance database over the period 1 January 1996-1 July 2002. Evaluation was based on a list of 243 reference signals (RSs) corresponding to investigations launched by the French Pharmacovigilance Technical Committee (PhVTC) during the same period. The comparison of detection methods was made on the basis of the number of RSs detected as well as the time to detection. Results comparing the five automated quantitative methods were in favour of GPS(pH0) in terms of both number of detections of true signals and

Pharmacovigilance in resource-limited countries.

Science.gov (United States)

Olsson, Sten; Pal, Shanthi N; Dodoo, Alex

2015-01-01

In the past 20 years, many low- and middle-income countries have created national pharmacovigilance (PV) systems and joined the WHO's global PV network. However, very few of them have fully functional systems. Scientific evidence on the local burden of medicine-related harm and their preventability is missing. Legislation and regulatory framework as well as financial support to build sustainable PV systems are needed. Public health programs need to integrate PV to monitor new vaccines and medicines introduced through these programs. Signal analysis should focus on high-burden preventable adverse drug problems. Increased involvement of healthcare professionals from public and private sectors, pharmaceutical companies, academic institutions and the public at large is necessary to assure a safe environment for drug therapy. WHO has a major role in supporting and coordinating these developments.

Investigating patient narratives posted on Internet and their informativeness level for pharmacovigilance purpose: The example of comments about statins.

Science.gov (United States)

Kheloufi, Farid; Default, Anne; Blin, Olivier; Micallef, Joelle

2017-09-01

Health-related networks like patient health forums may be considered as potential sources of information to early detect pharmacovigilance issues or complete data on drug safety. However, the clinical and pharmacological relevancy of such a source has not been clearly explored. We aimed to describe the characteristics and the informativeness level of Internet narratives posted by patients and mentioning adverse drug reactions (ADRs) related to statins. A retrospective cross-sectional study was conducted on an Internet website dedicated to share experience on medicines. One day of December 2012, postings about simvastatin, rosuvastatin and atorvastatin publicly available on the website were collected. Their informativeness according to 16 key elements of information (including drug start and stop date, duration of treatment, time to onset and duration of the ADR, outcome, medical history, concomitant medication) was assessed. General information about reported ADRs was also investigated. Among the 96 postings related to statins, 72 (40 women, 32 men; mean age: 59 [40-78]) mentioned at least one ADR accounting for a total of 176 ADRs. Musculoskeletal and connective tissue disorders (42.6%) and nervous system disorders (15.3%) were the main represented ADRs. Only 2 patients mentioned ADRs that could be considered as serious but 24 patients mentioned they stopped or switched their treatment toward another lipid modifying agent because of the ADR. Mean number of available key elements of information per narrative was 6/16. Time to onset and duration of the ADR were respectively available in only 31% and 3% of the narratives. Medical history and concomitant medication were respectively lacking in 87% and 86% of the narratives. Outcome was found only in 39% of the narratives. Patient narratives posted on Internet include mainly non-serious expected ADR. However, their informativeness level is very incomplete and makes difficult their assessment and use for

Pharmacovigilance of drug allergy and hypersensitivity using the ENDA-DAHD database and the GALEN platform. The Galenda project.

Science.gov (United States)

Bousquet, P-J; Demoly, P; Romano, A; Aberer, W; Bircher, A; Blanca, M; Brockow, K; Pichler, W; Torres, M J; Terreehorst, I; Arnoux, B; Atanaskovic-Markovic, M; Barbaud, A; Bijl, A; Bonadonna, P; Burney, P G; Caimmi, S; Canonica, G W; Cernadas, J; Dahlen, B; Daures, J-P; Fernandez, J; Gomes, E; Gueant, J-L; Kowalski, M L; Kvedariene, V; Mertes, P-M; Martins, P; Nizankowska-Mogilnicka, E; Papadopoulos, N; Ponvert, C; Pirmohamed, M; Ring, J; Salapatas, M; Sanz, M L; Szczeklik, A; Van Ganse, E; De Weck, A L; Zuberbier, T; Merk, H F; Sachs, B; Sidoroff, A

2009-02-01

Nonallergic hypersensitivity and allergic reactions are part of the many different types of adverse drug reactions (ADRs). Databases exist for the collection of ADRs. Spontaneous reporting makes up the core data-generating system of pharmacovigilance, but there is a large under-estimation of allergy/hypersensitivity drug reactions. A specific database is therefore required for drug allergy and hypersensitivity using standard operating procedures (SOPs), as the diagnosis of drug allergy/hypersensitivity is difficult and current pharmacovigilance algorithms are insufficient. Although difficult, the diagnosis of drug allergy/hypersensitivity has been standardized by the European Network for Drug Allergy (ENDA) under the aegis of the European Academy of Allergology and Clinical Immunology and SOPs have been published. Based on ENDA and Global Allergy and Asthma European Network (GA(2)LEN, EU Framework Programme 6) SOPs, a Drug Allergy and Hypersensitivity Database (DAHD((R))) has been established under FileMaker((R)) Pro 9. It is already available online in many different languages and can be accessed using a personal login. GA(2)LEN is a European network of 27 partners (16 countries) and 59 collaborating centres (26 countries), which can coordinate and implement the DAHD across Europe. The GA(2)LEN-ENDA-DAHD platform interacting with a pharmacovigilance network appears to be of great interest for the reporting of allergy/hypersensitivity ADRs in conjunction with other pharmacovigilance instruments.

Adverse Drug Reaction Reporting Pattern in Turkey: Analysis of the National Database in the Context of the First Pharmacovigilance Legislation.

Science.gov (United States)

Ozcan, Gulnihal; Aykac, Emel; Kasap, Yelda; Nemutlu, Nergiz T; Sen, Ebru; Aydinkarahaliloglu, N Demet

2016-03-01

In Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system. In this study, we aimed to analyse the ADR-reporting pattern in the context of the first pharmacovigilance legislation in Turkey. We analysed ADR reports submitted to the Turkish Pharmacovigilance Center (TUFAM) from 2005 to 2014 with respect to reporting rate (RR), patient characteristics, type of the ADRs, suspected drugs, source of the report and the profession of the reporter. The annual RR increased gradually over the study period. RRs for females were greater than those for males. RRs were highly correlated with age. Most commonly reported ADRs were skin and subcutaneous tissue disorders. Most commonly suspected drugs were antineoplastic and immunomodulating agents. There was no remarkable change in reporting pattern of ADRs, patient characteristics or classes of suspected drugs over the years. The most common source of reports was spontaneous reporting. Contribution of the reports from studies increased gradually. Most of the reports were reported by physicians. RRs by pharmacists increased substantially over the years. This study showed that the annual RR increased gradually over the 9-year study period. This increase was neither due to an increased reporting of a specific group of ADRs or drugs, nor to an increased reporting in a specific group of patients. There was a general increase in RR in parallel to pharmacovigilance activities.

The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France.

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Olivier, Pascale; Montastruc, Jean-Louis

2006-11-01

Because of design, objectives and number of included subjects, clinical studies are insufficient to assess the safety of new drugs. Sometimes, serious adverse drug reactions (ADRs) led to withdrawal of the drug from the market after their approval. The objective of our study was to determine the scientific evidences leading to drug withdrawal for pharmacovigilance reasons in France. Data coming from French Health Products Safety Agency, literature and Toulouse Pharmacovigilance Center allowed to identify all drugs withdrawn from the French market for pharmacovigilance reasons from 1998 to 2004. We classified data according to their study design (Randomized Clinical Trial [RCT], case serie or case report, case-control study, cohort study, observational study, animal study), the organ/system affected and the type of ADR. A total of 21 drugs were withdrawn for safety reasons between 1998 and 2004 in France. The most frequent ADRs were hepatic (n = 7), cardiovascular (n = 4) or neurological (n = 3) ones. Eleven withdrawals were due to type-B ('unexpected') reactions (52%). For 19 out of 21 drugs, scientific evidence leading to drug withdrawal came from spontaneous case reports (or case series). Among these, case reports were the sole evidence in 12 cases. Withdrawals were based on evidence from case reports in combination with case-control or cohort study in four cases, in combination with observational study in two cases or in combination with animal study in two other cases. In only one case, a RCT supported the decision. This study underlines the importance of spontaneous case reports in detecting signals and supporting withdrawal of drug for pharmacovigilance reasons in France. Health authorities suffer from lack of comparative data resource. In this perspective, a pharmaco-epidemiological population-based database could represent a helpful tool to both generate and test safety hypotheses.

An analysis of Vigimed, a global e-mail system for the exchange of pharmacovigilance information.

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Johansson, Kristina; Olsson, Sten; Hellman, Björn; Meyboom, Ronald H B

2007-01-01

The Internet provides novel ways for communication and data exchange between national regulators. One innovation was the introduction of Vigimed, an e-mail discussion forum for national pharmacovigilance centres (NPCs). We reviewed a sample of Vigimed messages to learn more about this new tool and about the problems encountered in everyday pharmacovigilance and how these are handled. We analysed the contents of 100 subsequent questions and the corresponding responses as stored in the Vigimed datafile. To the 100 questions circulated through Vigimed, 575 answers were received; mean number of answers per question 6, range 0-20. Fifty-five (77%) of the 71 collaborating countries and 88 (43%) of the 204 individuals who had access in the study period had submitted at least one question or answer. These countries were in all parts of the world and in various phases of development. A total of 38% of the questions concerned the regulatory status of a drug; 30% safety issues; 13% regulatory actions under consideration; and 10% drug use-related problems (more than one category possible). Of the questions, 89% concerned established drugs; 11% were classified as new. A total of 90% of the questions concerned specific active substances or drug groups. Of the drugs, 73% were classified as 'orthodox' and 9% as herbal; 4% were vaccines and 4% excipients. Emerging drug groups (anatomical therapeutic chemical codes) were NSAIDs and analgesics (M01, N02), antibacterials (J01), antiobesity drugs (A08), psychotropic drugs (N05) and antihistamines (R06). NPCs operate in a restricted environment and there is little published information about the daily practices and experiences at NPCs. Our study concerned a sample in a limited period in time. In the meantime, the use of Vigimed has greatly expanded. The data in the Vigimed records are subjected to confidentiality in regard to the identities of countries, staff members, drug products and pharmaceutical companies, which limits the

Assessment of pharmacovigilance approaches for monitoring the safety of antimalarial drugs in pregnancy

NARCIS (Netherlands)

Dellicour, S.O.M.C.

2014-01-01

Post-marketing surveillance of drugs used in pregnancy is challenging, especially in developing countries where resources for pharmacovigilance are rare. There is a need to establish simple but effective systems to monitor safety of drugs given during pregnancy in resource constrained countries.

Quality management system as a tool for improvement of the dutch pharmacovigilance system

NARCIS (Netherlands)

Zweers, P.G.M.A.; Van Puijenbroek, E.P.; Van Grootheest, A.C.

2009-01-01

Introduction: The Netherlands Pharmacovigilance centre Lareb started as a regional organization in 1985. In 1995 it was appointed by the Health Authorities as the national centre for collection and analysis for reports of adverse drug reactions. Since then, Lareb has become a solid, professional

[Hydroxychloroquine-induced hearing loss: First case of positive rechallenge and analysis of the French pharmacovigilance database].

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Chatelet, J-N; Auffret, M; Combret, S; Bondon-Guitton, E; Lambert, M; Gautier, S

2017-05-01

Several cases of hearing loss induced by hydroxychloroquine have been reported in the literature but the role of hydroxychloroquine still remains debated. We report the first case, to our knowledge, of hearing loss induced by hydroxychloroquine with a positive re challenge in a woman treated for systemic lupus. An analysis of the French pharmacovigilance database allowed to identify 23 additional cases of hearing loss in patients treated with hydroxychloroquine and, among them, 8 had systemic lupus. Despite an excellent tolerance and high efficacy-side effect ratio, this case report adds some evidence for an otoxicity of hydroxychloroquine. Copyright © 2016 Société Nationale Française de Médecine Interne (SNFMI). Published by Elsevier SAS. All rights reserved.

Sources of information on lymphoma associated with anti-tumour necrosis factor agents: comparison of published case reports and cases reported to the French pharmacovigilance system.

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Théophile, Hélène; Schaeverbeke, Thierry; Miremont-Salamé, Ghada; Abouelfath, Abdelilah; Kahn, Valentine; Haramburu, Françoise; Bégaud, Bernard

2011-07-01

Anti-tumour necrosis factor (TNF) agents, through their intense immunoregulatory effect, have been suspected to increase the risk of malignant lymphoma. However, the classical epidemiological approaches conducted over about the last 10 years have not totally succeeded in addressing the question of a causal or artifactual association. Therefore, the analysis of a substantial set of case reports, although usually considered as poorly generalizable to the general population, could be particularly informative. Two main sources of case reports in postmarketing settings are available; publications in medical journals and reports to pharmacovigilance systems. The aim of the study was to compare the characteristics of case reports from both these sources in order to understand whether they provided the same information for the investigation of the causal link between lymphoma and anti-TNF agents. All case reports of malignant lymphoma in patients treated with an anti-TNF agent published in MEDLINE and all reports to the French pharmacovigilance system up to 1 February 2010 were identified. Cases of malignant lymphoma identified in postmarketing surveillance from both sources were compared regarding the following variables: age, sex, anti-TNF agent involved, indication for use, type of lymphoma, prior or concomitant immunosuppressive drugs and time to onset of lymphoma. A total of 81 published case reports and 61 cases reported to the French pharmacovigilance system were compared. In published reports, patients were younger (p = 0.03) and more frequently receiving a first anti-TNF treatment (p = 0.03), particularly infliximab (p = 0.03). Conversely, in the pharmacovigilance system reports, a succession of different anti-TNFs (p = 0.03) and adalimumab (p French pharmacovigilance system differed markedly for all characteristics tested, except sex and the use of prior or concomitant immunosuppressive drugs. Published case reports favoured convincing arguments

An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study

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Subhrojyoti Bhowmick

2014-01-01

pharmacovigilance activities conducted during clinical trials; and, hence the functioning of the ECs to safeguard the safety of patients during clinical trials remains questionable. There is a definite need for immediate intervention in the form of mandatory training hours for EC members about pharmacovigilance activities and reporting timelines to ensure clinical trial s ubject safe t y in the long run.

Social media and pharmacovigilance: A review of the opportunities and challenges.

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Sloane, Richard; Osanlou, Orod; Lewis, David; Bollegala, Danushka; Maskell, Simon; Pirmohamed, Munir

2015-10-01

Adverse drug reactions come at a considerable cost on society. Social media are a potentially invaluable reservoir of information for pharmacovigilance, yet their true value remains to be fully understood. In order to realize the benefits social media holds, a number of technical, regulatory and ethical challenges remain to be addressed. We outline these key challenges identifying relevant current research and present possible solutions. © 2015 The British Pharmacological Society.

Veterinary pharmacovigilance in India: A need of hour.

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Kumar, Rishi; Kalaiselvan, Vivekanandan; Verma, Ravendra; Kaur, Ismeet; Kumar, Pranay; Singh, G N

2017-01-01

Veterinary pharmacovigilance (PV) is important for the Medicine which are used for treating disease in animals. It becomes more important when these animals are further used for producing food. Adverse drug reactions (ADRs) have a direct impact on animals and indirect impact on human beings, for example, through milk products, other animal producing food products. Currently, PV program of India is playing a vital role in assessing the safety of medicines in Indian Population. The safety of medicine in animals can be assessed by veterinary PV. The research institutes involved in animal research and veterinary hospitals can be considered as ADR monitoring centers to assess the safety of medicines on animals.

Knowledge, perception, practices and barriers of healthcare professionals in Bosnia and Herzegovina towards adverse drug reaction reporting and pharmacovigilance

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Maša Amrain

2014-09-01

Full Text Available Introduction: Pharmacovigilance is an arm of patient care. No one wants to harm patients, but unfortunately any medicine will sometimes do just this. Underreporting of adverse drug reactions by healthcare professionals is a major problem in many countries. In order to determine whether our pharmacovigilance system could be improved, and identify reasons for under-reporting, a study to investigate the role of health care professionals in adverse drug reaction (ADR reporting was performed.Methods: A pretested questionnaire comprising of 20 questions was designed for assessment of knowledge, perceptions, practice and barriers toward ADR reporting on a random sample of 1000 healthcare professionals in Bosnia and Herzegovina.Results: Of the 1000 respondents, 870 (87% completed the questionnaire. The survey showed that 62.9% health care professionals would report ADR to the Agency for Medicinal Products and Medical Device of Bosnia and Herzegovina (ALMBIH. Most of surveyed respondents has a positive perception towards ADR reporting, and believes that this is part of their professional and legal obligation, and they also recognize the importance of reporting adverse drug reactions. Only small percent (15.4% of surveyed health care professionals reported adverse drug reaction.Conclusions: The knowledge of ADRs and how to report them is inadequate among health care professionals. Perception toward ADR reporting was positive, but it is not reflected in the actual practice of ADRs, probably because of little experience and knowledge regarding pharmacovigilance. Interventions such as education and training, focusing on the aims of pharmacovigilance, completing the ADR form and clarifying the reporting criteria are strongly recommended.

Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland.

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O'Callaghan, J; Griffin, B T; Morris, J M; Bermingham, Margaret

2018-06-01

In Europe, changes to pharmacovigilance legislation, which include additional monitoring of medicines, aim to optimise adverse drug reaction (ADR) reporting systems. The legislation also makes provisions related to the traceability of biological medicines. The objective of this study was to assess (i) knowledge and general experience of ADR reporting, (ii) knowledge, behaviours, and attitudes related to the pharmacovigilance of biologicals, and (iii) awareness of additional monitoring among healthcare professionals (HCPs) in Ireland. Hospital doctors (n = 88), general practitioners (GPs) (n = 197), nurses (n = 104) and pharmacists (n = 309) completed an online questionnaire. There were differences in mean knowledge scores relating to ADR reporting and the pharmacovigilance of biologicals among the HCP groups. The majority of HCPs who use biological medicines in their practice generally record biologicals by brand name but practice behaviours relating to batch number recording differed between some professions. HCPs consider batch number recording to be valuable but also regard it as being more difficult than brand name recording. Most respondents were aware of the concept of additional monitoring but awareness rates differed between some groups. Among those who knew about additional monitoring, there was higher awareness of the inverted black triangle symbol among pharmacists (> 86.4%) compared with hospital doctors (35.1%), GPs (35.6%), and nurses (14.9%). Hospital pharmacists had more experience and knowledge of ADR reporting than other practising HCPs. This study highlights the important role hospital pharmacists play in post-marketing surveillance. There is a need to increase pharmacovigilance awareness of biological medicines and improve systems to support their batch traceability.

Heparin pharmacovigilance in Brazil.

Science.gov (United States)

Junqueira, Daniela Rezende Garcia; Viana, Thércia Guedes; Peixoto, Eliane R de M; Barros, Fabiana C R de; Carvalho, Maria das Graças; Perini, Edson

2011-01-01

To investigate the biological origin of injectable unfractioned heparin available in Brazilian market by discussing the impact of the profile of commercial products and the changes in heparin monograph on the drug safety. The Anvisa data base for the Registered Products of Pharmaceutical Companies and the Dictionary of Pharmaceutical Specialties (DEF 2008/2009) were searched. A survey with industries having an active permission for marketing the drug in Brazil was conducted. Five companies were granted a permission to market unfractioned heparin in Brazil. Three of them are porcine in origin and two of them are bovine in origin, with only one explicitly showing this information in the package insert. The effectiveness and safety of heparin studied in non-Brazilian populations may not represent the Brazilian reality, since most countries no longer produce bovine heparin. The currently marketed heparin has approximately 10% less anticoagulant activity than that previously produced and this change may have clinical implications. Evidence about the lack of dose interchangeability between bovine and porcine heparins and the unique safety profile of these drugs indicates the need to follow the treatment and the patients' response. Events threatening the patient's safety must be reported to the pharmacovigilance system in each particular country.

Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data.

Science.gov (United States)

Endrikat, J; Schwenke, C; Prince, M R

2015-07-01

To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Rates of reported ADRs were lower in elderly patients versus adults aged statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. Copyright © 2015 The Royal College of Radiologists. All rights reserved.

The past, present and perhaps future of pharmacovigilance: homage to Folke Sjoqvist.

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Moore, Nicholas

2013-05-01

Over the years since 1961 and the identification of thalidomide as the common link in thousands of birth defects, daily pharmacovigilance activities and signal generation have evolved from the analysis of individual case reports and imputology, to case series and underreporting, to spontaneous report databases and disproportionality analyses, to data mining in population databases. Regulatory requirements have also changed from purely passive monitoring and reacting to alerts to a proactive approach that includes risk management plans and risk minimization, and from reporting only by healthcare professionals to patient reporting and exploration of social media. The emphasis only on risk assessment is changing towards assessment of the risk/benefit ratio and the exploration of real-life efficacy studies to complement the measure of real-life risk. The interactions between industry and regulators have been amplified and strengthened. However, most adverse reactions, including severe ones, are related to well-known and often pharmacological effects of the older drugs, possibly with genetic predispositions. Prevention is the next frontier for pharmacovigilance, beyond simply generating alerts, and it involves not only the removal of drugs from the market, but also promotion of proper drug prescribing by better trained physicians and the proper use of drugs by better informed patients.

Awareness among tertiary care doctors about Pharmacovigilance Programme of India: Do endocrinologists differ from others?

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Pramod Kumar Sharma

2016-01-01

Full Text Available Background and Objectives: Reporting adverse drug reactions (ADRs associated with drug use is an important factor in patient safety. Majority of ADRs are preventable through improved prescribing and monitoring. Endocrinologists prescribe drugs with actions on almost all organs and for relatively longer durations. ADR are expected following the use of these drugs. Pharmacovigilance is the study of drug-related adverse effects aimed at protecting patients and public from drug-related harms. The concept of pharmacovigilance is relatively new in India, and this survey is an attempt to explore awareness among doctors of an establishing institution of national importance. Materials and Methods: The survey was conducted on faculty and resident doctors by administering a written structured questionnaire in a voluntary manner. The questionnaire contained questions meant to evaluate their awareness, understanding, and misconception about ADR reporting. Identity of the responder was kept confidential. Results: A total of 106 (faculty = 56; residents = 50 participated in survey. The most common cause cited for not reporting an ADR was “do not know how to report” by 64.15%. Majority of them (64% had no information about the Pharmacovigilance Programme of India (PvPI, and only few (8.5% had actually reported or published an ADR. Interpretation and Conclusions: ADRs are major public health problem that needs to be addressed at all levels of health care. High index of clinical suspicion are crucial for their timely detection and management. Various educational interventions have shown to improve medical professionals' awareness, understanding about ADRs and in their reporting behavior. PvPI is an important initiative toward ensuring patient safety.

Effectiveness of Pharmacovigilance Training of General Practitioners A Retrospective Cohort Study in the Netherlands Comparing Two Methods

NARCIS (Netherlands)

Gerritsen, Roald; Faddegon, Hans; Dijkers, Fred; van Grootheest, Kees; van Puijenbroek, Eugene

2011-01-01

Background: Spontaneous reporting is a cornerstone of pharmacovigilance. Unfamiliarity with the reporting of suspected adverse drug reactions (ADRs) is a major factor leading to not reporting these events. Medical education may promote more effective reporting. Numerous changes have been implemented

The Patient's Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization.

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Smith, Meredith Y; Benattia, Isma

2016-09-01

Patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. Biopharmaceutical companies are actively seeking to be more patient-centric in drug research and development by involving patients in identifying target disease conditions, participating in the design of, and recruitment for, clinical trials, and disseminating study results. Drug safety departments within the biopharmaceutical industry are at a similar inflection point. Rising rates of per capita prescription drug use underscore the importance of having robust pharmacovigilance systems in place to detect and assess adverse drug reactions (ADRs). At the same time, the practice of pharmacovigilance is being transformed by a host of recent regulatory guidances and related initiatives which emphasize the importance of the patient's perspective in drug safety. Collectively, these initiatives impact the full range of activities that fall within the remit of pharmacovigilance, including ADR reporting, signal detection and evaluation, risk management, medication error assessment, benefit-risk assessment and risk communication. Examples include the fact that manufacturing authorization holders are now expected to monitor all digital sources under their control for potential reports of ADRs, and the emergence of new methods for collecting, analysing and reporting patient-generated ADR reports for signal detection and evaluation purposes. A drug safety department's ability to transition successfully into a more patient-centric organization will depend on three defining attributes: (1) a patient-centered culture; (2) deployment of a framework to guide patient engagement activities; and (3) demonstrated proficiency in patient-centered competencies, including patient engagement, risk communication and patient preference assessment. Whether, and to what extent, drug safety departments embrace the new patient-centric imperative, and the methods and

A day in the life of a pharmacovigilance case processor

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Ritesh Bhangale

2017-01-01

Full Text Available Pharmacovigilance (PV has grown significantly in India in the last couple of decades. The etymological roots for the word “pharmacovigilance” are “Pharmakon” (Greek for drug and “Vigilare” (Latin for to keep watch. It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

Adverse drug reactions reporting in Calabria (Southern Italy) in the four-year period 2011-2014: impact of a regional pharmacovigilance project in light of the new European Legislation.

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Leporini, Christian; Marrazzo, Giuseppina; Mumoli, Laura; Esposito, Stefania; Gallelli, Luca; Mangano, Giovanna; Brancati, Giacomino; De Francesco, Emanuela Adele; Russo, Emilio; De Sarro, Giovambattista

2017-05-01

The number of suspected adverse drug reactions (ADRs) yearly submitted to the Italian Network of Pharmacovigilance (RNF) has progressively increased after the new European Pharmacovigilance legislation (July 2012). These results have mostly reflected the agreements between Italian Medicines Agency (AIFA) and Italian Regions, enabling the implementation of active pharmacovigilance projects. A project was funded by the AIFA in Calabria region (Southern Italy) in 2010 to increase ADRs reporting and promote a safer medicines' use. Based on this background, we investigated the trend of ADRs in Calabria in 2011-2014, trying to analyze the possible entailments of the new law. Quantitative and descriptive analysis of ADRs submitted by Calabrian healthcare professionals and patients to the RNF database between 2011 and 2014. A sharp rise in regional reporting rate was observed over study period. Calabrian Pharmacovigilance system completely fulfilled the World Health Organization gold standard for ADR reporting rate, both in 2013 and 2014. However, heterogeneity was observed regarding reporting health facilities, healthcare professionals and patients among the study years. These findings reflect the success of the project performed in Calabria. However, this initiative should go on in the next future to obtain better and more homogeneous reporting behavior.

Should methods of correction for multiple comparisons be applied in pharmacovigilance?

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Lorenza Scotti

2015-12-01

Full Text Available Purpose. In pharmacovigilance, spontaneous reporting databases are devoted to the early detection of adverse event ‘signals’ of marketed drugs. A common limitation of these systems is the wide number of concurrently investigated associations, implying a high probability of generating positive signals simply by chance. However it is not clear if the application of methods aimed to adjust for the multiple testing problems are needed when at least some of the drug-outcome relationship under study are known. To this aim we applied a robust estimation method for the FDR (rFDR particularly suitable in the pharmacovigilance context. Methods. We exploited the data available for the SAFEGUARD project to apply the rFDR estimation methods to detect potential false positive signals of adverse reactions attributable to the use of non-insulin blood glucose lowering drugs. Specifically, the number of signals generated from the conventional disproportionality measures and after the application of the rFDR adjustment method was compared. Results. Among the 311 evaluable pairs (i.e., drug-event pairs with at least one adverse event report, 106 (34% signals were considered as significant from the conventional analysis. Among them 1 resulted in false positive signals according to rFDR method. Conclusions. The results of this study seem to suggest that when a restricted number of drug-outcome pairs is considered and warnings about some of them are known, multiple comparisons methods for recognizing false positive signals are not so useful as suggested by theoretical considerations.

Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff

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Fabiana Rossi Varallo

Full Text Available OBJECTIVES: Most educational interventions in pharmacovigilance are designed to encourage physicians to report adverse drug reactions. However, multidisciplinary teams may play an important role in reporting drug-related problems. This study assessed the impact of a multifaceted educational intervention in pharmacovigilance on the knowledge, skills and attitudes of hospital professionals. METHOD: This prospective, open-label, non-randomized study was performed in a medium-complexity hospital in São Paulo, Brazil. The intervention involved four activities: 1 an interactive lecture, 2 a practical class, 3 a pre-post questionnaire administered to professionals on a multidisciplinary team, and 4 educational material. The intervention’s impact on the professionals’ knowledge and skills was assessed using the World Health Organization’s definitions. The intervention’s effect on the professionals’ attitudes was analysed by the prevalence of adverse drug event reports (adverse drug reactions, medication errors, therapeutic failure and drug quality deviations and the relevance (seriousness and expectancy of the events. RESULTS: One hundred seventy-three professionals were enrolled. A 70-fold increase in the number of adverse drug event reports was observed during the 12 months post-intervention. The intervention improved the professionals’ form-completion skills (p<0.0001 and their knowledge of pharmacovigilance (p<0.0001. The intervention also contributed to detecting serious drug-induced events. The nursing staff reported medication errors, and pharmacists and physiotherapists recognized serious adverse drug reactions. Physicians communicated suspicions of therapeutic failure. CONCLUSIONS: A multidisciplinary approach to drug-safety assessments contributes to identifying new, relevant drug-related problems and improving the rate of adverse drug event reporting. This strategy may therefore be applied to improve risk communication in

Role of Antigen Spread and Distinctive Characteristics of Immunotherapy in Cancer Treatment

NARCIS (Netherlands)

Gulley, J.L.; Madan, R.A.; Pachynski, R.; Mulders, P.; Sheikh, N.A.; Trager, J.; Drake, C.G.

2017-01-01

Immunotherapy is an important breakthrough in cancer. US Food and Drug Administration-approved immunotherapies for cancer treatment (including, but not limited to, sipuleucel-T, ipilimumab, nivolumab, pembrolizumab, and atezolizumab) substantially improve overall survival across multiple

Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data

International Nuclear Information System (INIS)

Endrikat, J.; Schwenke, C.; Prince, M.R.

2015-01-01

Aim: To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18–64 years. Materials and methods: Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Results: Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. Conclusions: This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. -- Highlights: •First dedicated safety study of an extracellular contrast agent in the elderly. •Elderly patients experience fewer non-serious ADRs than younger adults. •Gadobutrol has a favourable safety profile in both age groups

FDA Approves First Therapeutic Cancer Vaccine

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Sipuleucel-T (Provenge) is a relatively nontoxic treatment option for men with hormone-resistant or castration-resistant prostate cancer. The FDA's approval of the vaccine represented the first proof of principle that immunotherapy can work in cancer.

Network Security Issues in The Internet of Things (IoT)

OpenAIRE

Millar, Stuart

2016-01-01

This paper surveys a broad range of other research works in order to discuss network security issues in the Internet of Things (IoT). We begin with setting the scene generally with an outline of IoT, followed by a discussion of IoT layer models and topologies. After this, IoT standardization efforts and protocols are analysed, before we discuss in depth vulnerabilities, attacks and mitigations with regard IoT. It is concluded that ample research and narrative exists for protocols and vulnerab...

Drugs and dilated cardiomyopathies: A case/noncase study in the French PharmacoVigilance Database.

Science.gov (United States)

Montastruc, Guillaume; Favreliere, Sylvie; Sommet, Agnès; Pathak, Atul; Lapeyre-Mestre, Maryse; Perault-Pochat, Marie-Christine; Montastruc, Jean-Louis

2010-03-01

To evaluate putative associations between drugs and dilated cardiomyopathy. We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were all the observations with dilated cardiomyopathy registered into the FPVD between 1 January 1990 and 30 June 2007. Noncases were all other reports other than those studied. Anthracyclines were used as positive controls. Data were expressed as reporting odds ratio (ROR) with their 95% confidence intervals. Out of the 258 729 adverse drug reaction (ADR) reports recorded in the FPVD between 1 January 1990 and 30 June 2007, 47 (22 men, mean age 49 years) were defined as dilated cardiomyopathy. In these 47 patients, 67 drugs were 'suspect'. A significant ROR was found with cytotoxic (epirubicin, mitoxantrone, cyclophosphamide, gemcitabine, fluorouracil) and antiretroviral (lamividune, zidovudine, abacavir) but also with isotretinoin, prednisone, appetite suppressant (clobenzorex) and psychotropic [antipsychotic (clozapine, olanzapine), lithium, antidepressant (clomipramine, amitriptyline, fluvoxamine)] drugs. The present study describes an association between some drugs and reports of dilated cardiomyopathies. This relationship involves not only some already suspected drugs (anthracyclines, antiretrovirals), but also other drugs (antipsychotics, lithium, antidepressants, retinoids) less known to induce such an ADR. Despite the mandatory limits of this kind of study (underreporting, confounding factors . . .), these data represent a pharmacovigilance signal and could contribute to establish further prospective studies in order to confirm such signals.

Pharmacovigilance in oncology: pattern of spontaneous notifications, incidence of adverse drug reactions and under-reporting

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Marília Berlofa Visacri

2014-04-01

Full Text Available The high toxicity and narrow therapeutic window of antineoplastic agents makes pharmacovigilance studies essential in oncology. The objectives of the current study were to analyze the pattern of spontaneous notifications of adverse drug reactions (ADRs in oncology patients and to analyze the incidence of ADRs reported by outpatients on antineoplastic treatment in a tertiary care teaching hospital. To compose the pattern of ADR, the notification forms of reactions in oncology patients in 2010 were reviewed, and the reactions were classified based on the drug involved, mechanism, causality, and severity. To evaluate the incidence of reactions, a questionnaire at the time of chemotherapy was included, and the severity was classified based on the Common Terminology Criteria. The profiles of the 10 responses reported to the Pharmacovigilance Sector were type B, severe, possible, and they were primarily related to platinum compounds and taxanes. When the incidence of reactions was analyzed, it was observed that nausea, alopecia, fatigue, diarrhea, and taste disturbance were the most frequently reported reactions by oncology patients, and the grade 3 and 4 reactions were not reported. Based on this analysis, it is proposed that health professionals should be trained regarding notifications and clinical pharmacists should increasingly be brought on board to reduce under-reporting of ADRs.

Epistaxis and other haemorrhagic events associated with the smoking cessation medicine varenicline : a case series from two national pharmacovigilance centres

NARCIS (Netherlands)

Harrison-Woolrych, Mira; Harmark, Linda; Tan, Ming; Maggo, Simran; van Grootheest, Kees

Purpose To present a case series of haemorrhagic events associated with varenicline identified from the New Zealand (NZ) and Netherlands national pharmacovigilance centres and propose a possible mechanism for these adverse events. Methods Reports of epistaxis and other haemorrhagic events (in all

Interstitial lung disease induced by fluoxetine: Systematic review of literature and analysis of Vigiaccess, Eudravigilance and a national pharmacovigilance database.

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Deidda, Arianna; Pisanu, Claudia; Micheletto, Laura; Bocchetta, Alberto; Del Zompo, Maria; Stochino, Maria Erminia

2017-06-01

We investigated a pulmonary adverse drug reaction possibly induced by fluoxetine, the Interstitial Lung Disease, by performing a systematic review of published case reports on this subject, a review of the World Health Organization VigiAccess database, of the European EudraVigilance database and of a national Pharmacovigilance database (Italian Pharmacovigilance Network). The research found a total of seven cases linking fluoxetine to Interstitial Lung Disease in the literature. 36 cases of interstitial lung disease related to fluoxetine were retrieved from the VigiAccess database (updated to July 2016), and 36 reports were found in EudraVigilance database (updated to June 2016). In the Italian Pharmacovigilance database (updated to August 2016), we found only one case of Interstitial Lung Disease, codified as "pulmonary disease". Our investigation shows that fluoxetine might be considered as a possible cause of Interstitial Lung Disease. In particular, although here we do not discuss the assessment of benefits and harms of fluoxetine, since this antidepressant is widely used, our review suggests that fluoxetine-induced Interstitial Lung Disease should be considered in patients with dyspnea, associated or not with dry cough, who are treated with this drug. An early withdrawn of fluoxetine could be useful to obtain a complete remission of this adverse drug reaction and special attention should be particularly devoted to long-term therapy, and to female and elderly patients. Although the spontaneous reporting system is affected by important limitations, drug post- marketing surveillance represents an important tool to evaluate the real world effectiveness and safety of drugs. Copyright © 2017 Elsevier Ltd. All rights reserved.

Semantic distance-based creation of clusters of pharmacovigilance terms and their evaluation.

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Dupuch, Marie; Grabar, Natalia

2015-04-01

Pharmacovigilance is the activity related to the collection, analysis and prevention of adverse drug reactions (ADRs) induced by drugs or biologics. The detection of adverse drug reactions is performed using statistical algorithms and groupings of ADR terms from the MedDRA (Medical Dictionary for Drug Regulatory Activities) terminology. Standardized MedDRA Queries (SMQs) are the groupings which become a standard for assisting the retrieval and evaluation of MedDRA-coded ADR reports worldwide. Currently 84 SMQs have been created, while several important safety topics are not yet covered. Creation of SMQs is a long and tedious process performed by the experts. It relies on manual analysis of MedDRA in order to find out all the relevant terms to be included in a SMQ. Our objective is to propose an automatic method for assisting the creation of SMQs using the clustering of terms which are semantically similar. The experimental method relies on a specific semantic resource, and also on the semantic distance algorithms and clustering approaches. We perform several experiments in order to define the optimal parameters. Our results show that the proposed method can assist the creation of SMQs and make this process faster and systematic. The average performance of the method is precision 59% and recall 26%. The correlation of the results obtained is 0.72 against the medical doctors judgments and 0.78 against the medical coders judgments. These results and additional evaluation indicate that the generated clusters can be efficiently used for the detection of pharmacovigilance signals, as they provide better signal detection than the existing SMQs. Copyright © 2014. Published by Elsevier Inc.

Harnessing scientific literature reports for pharmacovigilance. Prototype software analytical tool development and usability testing.

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Sorbello, Alfred; Ripple, Anna; Tonning, Joseph; Munoz, Monica; Hasan, Rashedul; Ly, Thomas; Francis, Henry; Bodenreider, Olivier

2017-03-22

We seek to develop a prototype software analytical tool to augment FDA regulatory reviewers' capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability testing to assess design, performance, and user satisfaction with the tool. A prototype, open source, web-based, software analytical tool generated statistical disproportionality data mining signal scores and dynamic visual analytics for ADE safety signal detection and management. We leveraged Medical Subject Heading (MeSH) indexing terms assigned to published citations in PubMed/MEDLINE to generate candidate drug-adverse event pairs for quantitative data mining. Six FDA regulatory reviewers participated in usability testing by employing the tool as part of their ongoing real-life pharmacovigilance activities to provide subjective feedback on its practical impact, added value, and fitness for use. All usability test participants cited the tool's ease of learning, ease of use, and generation of quantitative ADE safety signals, some of which corresponded to known established adverse drug reactions. Potential concerns included the comparability of the tool's automated literature search relative to a manual 'all fields' PubMed search, missing drugs and adverse event terms, interpretation of signal scores, and integration with existing computer-based analytical tools. Usability testing demonstrated that this novel tool can automate the detection of ADE safety signals from published literature reports. Various mitigation strategies are described to foster improvements in design, productivity, and end user satisfaction.

From Big Data to Smart Data for Pharmacovigilance: The Role of Healthcare Databases and Other Emerging Sources.

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Trifirò, Gianluca; Sultana, Janet; Bate, Andrew

2018-02-01

In the last decade 'big data' has become a buzzword used in several industrial sectors, including but not limited to telephony, finance and healthcare. Despite its popularity, it is not always clear what big data refers to exactly. Big data has become a very popular topic in healthcare, where the term primarily refers to the vast and growing volumes of computerized medical information available in the form of electronic health records, administrative or health claims data, disease and drug monitoring registries and so on. This kind of data is generally collected routinely during administrative processes and clinical practice by different healthcare professionals: from doctors recording their patients' medical history, drug prescriptions or medical claims to pharmacists registering dispensed prescriptions. For a long time, this data accumulated without its value being fully recognized and leveraged. Today big data has an important place in healthcare, including in pharmacovigilance. The expanding role of big data in pharmacovigilance includes signal detection, substantiation and validation of drug or vaccine safety signals, and increasingly new sources of information such as social media are also being considered. The aim of the present paper is to discuss the uses of big data for drug safety post-marketing assessment.

The role of Clinical Pharmacists in the improvement of a pharmacovigilance system: A review of the reported adverse drug reactions during 2004-2010 in Mazandaran Province of Iran

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Elham Azhdari

2013-02-01

Full Text Available Background: Following establishment of Iranian Adverse Drug Reaction (ADR Monitoring Center in 1997, ADR committees were established in all hospitals of Mazandaran Province of Iran. Clinical pharmacists from Mazandaran University of Medical Sciences have been involved with these committees since 2007. The aim of this study was to compare the results of the pharmacovigilance system before and after active involvement of clinical pharmacists. Methods: This study included Yellow Cards filled out by healthcare providers in Mazandaran Province during 2004-2010. Frequency of Adverse Drug Reactions (ADRs, route of administration, reporters, number of reports in each years and damaged organs were focuses. Statistical analysis was performed by SPSS 16 software. P Results: A total of 793 yellow cards were completed during 2004 – 2010. Only 38 ADRs (4.8% were related to 2004-2007. Most of the reports generated by Nurses (49.3% followed by Pharmacists and Physicians (P Conclusion: Clinical pharmacists’ intervention regarding establishing ADR committees in the hospitals improved the output of the pharmacovigilance system, although under-reporting is still a major drawback of spontaneous reporting. Keywords: Pharmacovigilance, Adverse Drug Reaction, Mazandaran, Adverse Drug Reaction Reporting Systems

[Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

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Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

2008-03-01

Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

Educational Paper: Aspects of clinical pharmacology in children--pharmacovigilance and safety.

Science.gov (United States)

Choonara, Imti

2013-05-01

Adverse drug reactions (ADRs) are a significant problem in children, affecting one in ten children in hospital. Within the community, one in 500 children will experience an adverse drug reaction each year. Pharmacovigilance has been useful in detecting suspected ADRs. However, most ADRs are unreported and often not suspected. Education of health professionals in relation to drug toxicity improves the reporting rate of suspected ADRs. Clinical trials are useful to evaluate the efficacy of drugs. They are, however, not the best way of looking at ADRs where surveillance following the widespread use of a drug is more appropriate. Alongside work by the regulatory agencies, independent investigators have helped collate data. This information has been useful in developing guidelines to prevent further cases of drug toxicity. Greater awareness and understanding of drug toxicity in children should result in more rational prescribing.

Pharmacovigilance activities in ASEAN countries.

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Suwankesawong, Wimon; Dhippayom, Teerapon; Tan-Koi, Wei-Chuen; Kongkaew, Chuenjid

2016-09-01

This study aimed to explore the current landscape and identify challenges of pharmacovigilance (PV) among Association of Southeast Asian Nations (ASEAN) countries. This cross-sectional survey collected data from May 2014 to December 2015. Questionnaires seeking to collect information on resources, processes, roles and responsibility, and functions of PV systems were sent to relevant persons in the ASEAN countries. Functions of PV centers were measured using the minimum World Health Organization requirements for a functional national PV system. Performances of PV centers were measured by the following: (1) the indicators related to the average number of individual case safety reports (ICSR); (2) presence of signal detection activities and subsequent action; and (3) contribution to the global vigilance database. Cambodia, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam completed the survey. PV systems in four surveyed countries (Indonesia, Malaysia, Singapore, and Thailand) achieved all aspects of the World Health Organization minimum requirement for a functional national PV system; the remaining countries were deemed to have unclear communication strategies and/or no official advisory committee. Average numbers of recent ICSR national returns ranged from 7 to 3817 reports/year/million population; three countries (Malaysia, Singapore, and Thailand) demonstrated good performance in reporting system and reported signal detection activities and subsequent actions. All participating countries had submitted ICSRs to the Uppsala Monitoring Center during the survey period (2013-2015). Four participating countries had functional PV systems. PV capacity, functionality, and legislative framework varied depending on local healthcare ecosystem networks. Implementing effective communication strategies and/or technical assistance from the advisory committee are needed to strengthen PV in ASEAN. Copyright © 2016 John Wiley & Sons, Ltd. Copyright �

Pharmacovigilance study of Ayurvedic medicine in Ayurvedic Teaching Hospital: A prospective survey study.

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Ajanal, Manjunath N; Nayak, Shradda U; Kadam, Avinash P; Prasad, B S

2015-01-01

Though Ayurveda is practiced in the Indian subcontinent since centuries, there is a paucity of systematic documentation related to the occurrence of adverse drug reactions (ADR) and other issues regarding the safety of Ayurveda medicines. To monitor and analyze the pattern and frequency of ADR to Ayurvedic medicines in an Ayurvedic hospital setup. In this prospective study, ADR monitoring was done in KLE Ayurveda Secondary Care Hospital, Belgaum, Karnataka, India by spontaneous and intensive monitoring technique for a span of 1-year (June 2010 to May 2011). Data pertaining to patient demography, drug and reaction characteristics, organ system involved and reaction outcomes were collected and evaluated. The reaction severity and predisposing factors were also assessed. In a span of one year, 84 adverse drug events were reported out of which 52 confirmed as ADR. The overall incidence of ADR in the patient population was 1.14%, out of which 23 (44.23%) were related to Panchakarma (detoxification process), 13 (25.00%) related to the herbal formulations and 06 (11.53%) were of Rasa Aushadhi (mineral or herbo-mineral formulations). The commonly affected organ systems were gastrointestinal system 24 (46.15%) and skin 15 (28.84%). The majority of the reactions were moderate 30 (57.69%) to mild 20 (38.46%) in severity. Most patients recovered from the incidence. The present work has documented the incidence and characteristic of ADR to Ayurvedic medicine in a typical Ayurveda hospital setup. This will help in developing various strategies for boosting pharmacovigilance in Ayurveda, thereby ensuring safer use of Ayurveda medicines.

CONOCIMIENTOS Y PRÁCTICAS SOBRE FARMACOVIGILANCIA EN PERSONAL DE ESTOMATOLOGÍA

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Ruiz Hernández A

2014-03-01

Full Text Available Cuban system of pharmacovigilance had insufficient reports of adverse drug reactions from personal of dentistry, which constitutes a problem. Our aim was identify knowledge and practical of pharmacovigilance from dentists at Guanabacoa municipality. Method. Observational, descriptive and traverse study. We inquired 104 people (45 dentists and 59 technicians about knowledge and practical in pharmacovigilance. We also asked about years of professional experience, specialty or scientific category. The study was conducted from December 2011 to January 2012. Results. We observed dentists didn't know adverse drug reaction concept (99% although they recognized drug can cause adverse reaction (76%; they didn't know the Cuban official model to report adverse drug reactions (94,2% but the majority recognized pharmacovigilance usefulness (92,3%; they said inform an adverse drug reaction if it appear (85,6%; dentists didn't consult correct sources of information about pharmacovigilance (63,5%; not all of them asked to patient about medications (75%; greater part of them never reported an adverse drug reaction (90,4%. Much of these persons had more than 5 years of professional experience (65,4%; more than middle of dentists was specialist (55,6% but a few of them showed educational or scientific category (9,8%. Conclusions. The knowledge and practical in pharmacovigilance from dentists were deficient; educational and administration strategies about pharmacovigilance can revert these results and improve sanitary attention.

Hearing impairment associated with oral terbinafine use : a case series and case/non-case analysis in the Netherlands Pharmacovigilance Centre Lareb database and VigiBase™

NARCIS (Netherlands)

Scholl, Joep H G; van Puijenbroek, Eugene P

2012-01-01

BACKGROUND: The Netherlands Pharmacovigilance Centre Lareb received reports of six cases of hearing impairment in association with oral terbinafine use. This study describes these cases and provides support for this association from the Lareb database for spontaneous adverse drug reaction (ADR)

tDCS for Memory Enhancement: Analysis of the Speculative Aspects of Ethical Issues.

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Voarino, Nathalie; Dubljević, Veljko; Racine, Eric

2016-01-01

Transcranial direct current stimulation (tDCS) is a promising technology to enhance cognitive and physical performance. One of the major areas of interest is the enhancement of memory function in healthy individuals. The early arrival of tDCS on the market for lifestyle uses and cognitive enhancement purposes lead to the voicing of some important ethical concerns, especially because, to date, there are no official guidelines or evaluation procedures to tackle these issues. The aim of this article is to review ethical issues related to uses of tDCS for memory enhancement found in the ethics and neuroscience literature and to evaluate how realistic and scientifically well-founded these concerns are? In order to evaluate how plausible or speculative each issue is, we applied the methodological framework described by Racine et al. (2014) for "informed and reflective" speculation in bioethics. This framework could be succinctly presented as requiring: (1) the explicit acknowledgment of factual assumptions and identification of the value attributed to them; (2) the validation of these assumptions with interdisciplinary literature; and (3) the adoption of a broad perspective to support more comprehensive reflection on normative issues. We identified four major considerations associated with the development of tDCS for memory enhancement: safety, autonomy, justice and authenticity. In order to assess the seriousness and likelihood of harm related to each of these concerns, we analyzed the assumptions underlying the ethical issues, and the level of evidence for each of them. We identified seven distinct assumptions: prevalence, social acceptance, efficacy, ideological stance (bioconservative vs. libertarian), potential for misuse, long term side effects, and the delivery of complete and clear information. We conclude that ethical discussion about memory enhancement via tDCS sometimes involves undue speculation, and closer attention to scientific and social facts would bring

Sistema de Farmacovigilância do Ceará: um ano de experiência Ceará State Pharmacovigilance System: a year of experience

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Helena Lutéscia Coêlho

1999-09-01

Full Text Available No presente trabalho, o relato do primeiro ano de atividade do Sistema de Farmacovigilância do Ceará (SIFACE é apresentado como estratégia para a discussão de questões práticas e metodológicas envolvendo as dificuldades na implantação de atividade dessa natureza no Brasil. O SIFACE está sendo estruturado pelo GPUIM (Grupo de Prevenção ao Uso Indevido de Medicamentos, tendo como ponto de apoio as unidades de farmácias hospitalares. Foram processadas 63 notificações (119 suspeitas de reação adversa, em sua maioria correspondentes a mulheres (55,7% e a pacientes de 0-14 anos (34,4%, sendo os antibióticos e as reações dermatológicas os medicamentos e os tipos de reações mais freqüentes, respectivamente. Em 20% dos casos houve reexposição dos pacientes a fármacos aos quais aqueles eram intolerantes, o que ressalta a importância preventiva da farmacovigilância.This paper summarizes the first year of activity of the Ceará State Pharmacovigilance System (SIFACE as a strategy to discuss practical and methodological problems related to developing pharmacovigilance in Brazil. SIFACE is being structured by the Group for the Prevention of Improper Use of Pharmaceuticals (GPUIM, based on hospital pharmacies. A total of 63 reports (119 suspected adverse drug reactions, or ADRs were processed, the majority among women (55.7% and children (34.4%. Antibiotics were the drug group most frequently involved, and the most common reactions were dermatological. In 20% of the cases, patients had been re-exposed to drugs previously reported as producing adverse reactions, thus highlighting the importance of pharmacovigilance to prevent ADRs.

Review of D-T Experiments Relevant to Burning Plasma Issues

International Nuclear Information System (INIS)

Hawryluk, R.J.

2001-01-01

Progress in the performance of tokamak devices has enabled not only the production of significant bursts of fusion energy from deuterium-tritium (D-T) plasmas in the Tokamak Fusion Test Reactor (TFTR) and the Joint European Torus (JET) but, more importantly, the initial study of the physics of burning magnetically confined plasmas. The TFTR and JET, in conjunction with the worldwide fusion effort, have studied a broad range of topics including magnetohydrodynamic stability, transport, wave-particle interactions, the confinement of energetic particles, and plasma boundary interactions. The D-T experiments differ in three principal ways from previous experiments: isotope effects associated with the use of deuterium-tritium fuel, the presence of fusion-generated alpha particles, and technology issues associated with tritium handling and increased activation. The effect of deuterium-tritium fuel and the presence of alpha particles is reviewed and placed in the perspective of the much large r worldwide database using deuterium fuel and theoretical understanding. Both devices have contributed substantially to addressing the scientific and technical issues associated with burning plasmas. However, future burning plasma experiments will operate with larger ratios of alpha heating power to auxiliary power and will be able to access additional alpha-particle physics issues. The scientific opportunities for extending our understanding of burning plasmas beyond that provided by current experiments is described

An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy

NARCIS (Netherlands)

Richardson, Jonathan Luke; Stephens, Sally; Thomas, Simon Hugh Lynton; Jamry-Dziurla, Anna; Jong-van den Berg, de Lolkje; Zetstra-van der Woude, Priscilla; Laursen, Maja; Hliva, Valerie; Mt-Isa, Shahrul; Bourke, Alison; Dreyer, Nancy A; Blackburn, Stella Cf

2016-01-01

BACKGROUND: Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized

Therapeutic monoclonal antibodies and the need for targeted pharmacovigilance in India.

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Kalaivani, M; Singh, Abhishank; Kalaiselvan, V

2015-01-01

A growing number of innovative mAb therapeutics are on the global market, and biosimilar versions have now also been approved, including in India. Although efficacy and safety is demonstrated prior to approval, targeted pharmacovigilance is essential for the identification and assessment of risk for any mAb products. We analyzed the ADR data related to mAbs reported to the NCC-PvPI through the spontaneous reporting system Vigiflow during April 2011 to February 2014 to identify mAbs with the highest number of ADR including fatal/serious ADR. Only 0.72% reports were related to mAbs. Although 15 mAbs are approved in the country, only 6 mAbs were reported through Vigiflow. Rituximab was highly reported, and no fatal/serious ADR related to any mAbs were reported during the study period. Our study shows that PvPI is effective and robust system in the detection and assessment of risks associated with the use of mAbs.

The impact of database restriction on pharmacovigilance signal detection of selected cancer therapies.

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Hauben, Manfred; Hung, Eric; Wood, Jennifer; Soitkar, Amit; Reshef, Daniel

2017-05-01

The aim of this study was to investigate whether database restriction can improve oncology drug pharmacovigilance signal detection performance. We used spontaneous adverse event (AE) reports in the United States (US) Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Positive control (PC) drug medical concept (DMC) pairs were selected from safety information not included in the product's first label but subsequently added as label changes. These medical concepts (MCs) were mapped to the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs) used in FAERS to code AEs. Negative controls (NC) were MCs with circumscribed PTs not included in the corresponding US package insert (USPI). We calculated shrinkage-adjusted observed-to-expected (O/E) reporting frequencies for the aforementioned drug-PT pairs. We also formulated an adjudication framework to calculate performance at the MC level. Performance metrics [sensitivity, specificity, positive and negative predictive value (PPV, NPV), signal/noise (S/N), F and Matthews correlation coefficient (MCC)] were calculated for each analysis and compared. The PC reference set consisted of 11 drugs, 487 PTs, 27 MCs, 37 drug-MC combinations and 638 drug-event combinations (DECs). The NC reference set consisted of 11 drugs, 9 PTs, 5 MCs, 40 drug-MC combinations and 67 DECs. Most drug-event pairs were not highlighted by either analysis. A small percentage of signals of disproportionate reporting were lost, more noise than signal, with no gains. Specificity and PPV improved whereas sensitivity, NPV, F and MCC decreased, but all changes were small relative to the decrease in sensitivity. The overall S/N improved. This oncology drug restricted analysis improved the S/N ratio, removing proportionately more noise than signal, but with significant credible signal loss. Without broader experience and a calculus of costs and utilities of correct versus incorrect classifications in

The importance of Pharmacovigilance for the drug safety: Focus on cardiovascular profile of incretin-based therapy.

Science.gov (United States)

Sportiello, Liberata; Rafaniello, Concetta; Scavone, Cristina; Vitale, Cristiana; Rossi, Francesco; Capuano, Annalisa

2016-01-01

With the recent introduction of the new European Pharmacovigilance legislation, all new drugs must be carefully monitored after admission on the European market, in order to assess the long safety profile. Currently, special attention is given to several hypoglycemic agents with recent market approval (agonists of glucagon-like peptide-1 [GLP-1] receptor and dipeptidyl peptidase 4 inhibitors [DPP-4i]), which act through the potentiation of incretin hormone signaling. Their inclusion in European additional monitoring is also due to safety problems, which seem to characterize their pharmacological class. In fact, these drugs initially showed a good tolerability profile with mainly gastrointestinal adverse events, low risk of hypoglycemia and minor effects on body weight. But, new concerns such as infections, pancreatitis, pancreatic cancer and above all cardiovascular events (especially risk of heart failure requiring hospitalization) are now arising. In this review, we highlighted aspects of the new Pharmacovigilance European dispositions, and then we investigated the tolerability profile of incretin-based therapies, in particular DPP-4 inhibitors. Notably, we focused our attention on new safety concerns, which are emerging mostly in the post-marketing period, as the cardiovascular risk profile. Evidence in literature and opinions of regulatory agencies (e.g., European Medicines Agency and Food and Drug Administration) about risks of incretin-based therapies are yet controversial, and there are many open questions in particular on cancer and cardiovascular effects. Thus, it is important to continue to monitor closely the use of these drugs in clinical practice to improve the knowledge on their long-term safety and their place in diabetes therapy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Strategic Research for S&T Planning Should Focus on Key Issues

Institute of Scientific and Technical Information of China (English)

无

2004-01-01

@@ Strategic planning for national and CAS mid- and long-term S&T development should avoid giving equal attention to every aspect of an issue, which can only lead to incremental progress.Instead, importance should be attached to priorities that will result in scientific, technical and engineering breakthroughs, said CAS President Lu Yongxiang, who is also vice-chairman of the national legislature, NPC.

Hospital medication errors in a pharmacovigilance system in Colombia

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Jorge Enrique Machado-Alba

2015-11-01

Full Text Available Objective: this study analyzes the medication errors reported to a pharmacovigilance system by 26 hospitals for patients in the healthcare system of Colombia. Methods: this retrospective study analyzed the medication errors reported to a systematized database between 1 January 2008 and 12 September 2013. The medication is dispensed by the company Audifarma S.A. to hospitals and clinics around Colombia. Data were classified according to the taxonomy of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP. The data analysis was performed using SPSS 22.0 for Windows, considering p-values < 0.05 significant. Results: there were 9 062 medication errors in 45 hospital pharmacies. Real errors accounted for 51.9% (n = 4 707, of which 12.0% (n = 567 reached the patient (Categories C to I and caused harm (Categories E to I to 17 subjects (0.36%. The main process involved in errors that occurred (categories B to I was prescription (n = 1 758, 37.3%, followed by dispensation (n = 1 737, 36.9%, transcription (n = 970, 20.6% and administration (n = 242, 5.1%. The errors in the administration process were 45.2 times more likely to reach the patient (CI 95%: 20.2–100.9. Conclusions: medication error reporting systems and prevention strategies should be widespread in hospital settings, prioritizing efforts to address the administration process.

Public awareness and perception toward Adverse Drug Reactions reporting in Riyadh, Saudi Arabia.

Science.gov (United States)

Sales, Ibrahim; Aljadhey, Hisham; Albogami, Yasser; Mahmoud, Mansour A

2017-09-01

Purpose: To assess the general public awareness and perception about Adverse Drug Reactions (ADRs) reporting and pharmacovigilance. Method: A cross-sectional study conducted on June 2012 during awareness campaign held in two malls in Riyadh city for two days. A self-administered questionnaire consisting of three parts was distributed to the attendees who accepted to participate in the study. Results: A total of 204 questionnaires were collected with a response rate of 68%. Twenty-three percent could correctly define ADRs. Only 13(15.7%) of responders were familiar with the term "Pharmacovigilance" and only 78.6% were aware about the Saudi Pharmacovigilance Center. Sixty-seventy percent indicated that their physicians or pharmacists don't actively encourage them to report ADRs that may occur when they take their medications. The majority of responders (73.2%) believed that the medical team, rather than consumers, should report ADRs. When asked why patients do not report ADRs, 19.1(48.5%) believed that patients do not know whether the ADR is from the medication or not, 18.1(46.1%) stated that the reason was because patients don't know about the Pharmacovigilance Center, 16(40.7%) think that patients don't know about the importance of ADRs reporting, and 14(36.3%) responded that patients probably don't know how to report ADRs. Conclusion: The general public in Saudi Arabia are not aware about ADRs reporting and the pharmacovigilance system. The Saudi Food and Drug Authorities (FDA) need to put more efforts to increasing public awareness about the importance of ADRs reporting process and the importance of pharmacovigilance system in promoting patient safety.

Do package inserts reflect symptoms experienced in practice?: assessment using an automated phone pharmacovigilance system with varenicline and zolpidem in a primary care setting.

Science.gov (United States)

Haas, Jennifer S; Amato, Mary; Marinacci, Lucas; Orav, E John; Schiff, Gordon D; Bates, David W

2012-08-01

While the US FDA maintains a voluntary reporting system, postmarketing adverse drug events (ADEs) are underreported, and this case report-based system does not allow accurate determination of incidence. The aim of the study was to assess the usefulness of an automated phone pharmacovigilance system for ambulatory patients by comparing systematically collected, patient-reported symptoms to reflect possible ADEs with those reported on the package inserts of two drugs with postmarketing safety concerns, varenicline and zolpidem. English-speaking adults who received a prescription for zolpidem (n = 370) or varenicline (n = 107) from a primary care physician at one of 11 participating clinics, and who participated in the pharmacovigilance system during 2008-2010, were included in the study. Patients were called approximately 4 weeks following their visit and asked to complete a standard script that asked about adherence and pre-specified symptoms. The main outcome measures were elicited rates of pre-specified symptoms or possible ADEs. Compared with the package insert, patients taking zolpidem were significantly (p zolpidem were not detected. These data highlight the potential value of, and innovative ways of collecting, information about possible ADEs directly from patients.

Donor support for quality assurance and pharmacovigilance of anti-malarials in malaria-endemic countries.

Science.gov (United States)

Kovacs, Stephanie D; Mills, Brianna M; Stergachis, Andy

2017-07-11

Malaria control efforts have been strengthened by funding from donor groups and government agencies. The Global Fund to Fight AIDS, Tuberculosis and the Malaria (Global Fund), the US President's Malaria Initiative (PMI) account for the majority of donor support for malaria control and prevention efforts. Pharmacovigilance (PV), which encompasses all activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, is a necessary part of efforts to reduce drug resistance and improve treatment outcomes. This paper reports on an analysis of PV plans in the Global Fund and PMI and World Bank's grants for malaria prevention and control. All active malaria grants as of September 2015 funded by the Global Fund and World Bank, and fiscal year 2015 and 2016 PMI Malaria Operational Plans (MOP) were identified. The total amount awarded for PV-related activities and drug quality assurance was abstracted. A Key-Word-in-Context (KWIC) analysis was conducted for the content of each grant. Specific search terms consisted of pharmacovigilance, pregn*, registry, safety, adverse drug, mass drug administration, primaquine, counterfeit, sub-standard, and falsified. Grants that mentioned PV activities identified in the KWIC search, listed PV in their budgets, or included the keywords: counterfeit, sub-standard, falsified, mass drug administration, or adverse event were thematically coded using Dedoose software version 7.0. The search identified 159 active malaria grants including 107 Global Fund grants, 39 fiscal year 2015 and 2016 PMI grants and 13 World Bank grants. These grants were primarily awarded to low-income countries (57.2%) and in sub-Saharan Africa (SSA) (70.4%). Thirty-seven (23.3%) grants included a budget line for PV- or drug quality assurance-related activities, including 21 PMI grants and 16 Global Fund grants. Only 23 (14.5%) grants directly mentioned PV. The primary focus area was improving drug

Analysis of concentrating PV-T systems for the commercial/industrial sector. Volume III. Technical issues and design guidance

Energy Technology Data Exchange (ETDEWEB)

Schwinkendorf, W.E.

1984-09-01

This report provide appropriate guidance for addressing the major technical issues associated with the design and installation of a photovoltaic-thermal (PV-T) system. Nomographs are presented for developing preliminary sizing and costing, and issues associated with specific components and the overall design of the electrical and mechanical system are discussed. SAND82-7157/2 presents a review of current PV-T technology and operating systems and a study of potential PV-T applications. Detailed PV-T system designs for three selected applications and the results of a trade-off study for these applications are presented in SAND82-7157/4. A summary of the major results of this entire study and conclusions concerning PV-T systems and applications is presented in SAND82-7157/1.

Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India: A multicentre questionnaire-based observational study

Directory of Open Access Journals (Sweden)

Aman Goyal

2017-01-01

Interpretation & conclusions: Majority of the physicians though were aware of the regulatory changes with regard to pioglitazone, but their prescribing patterns were not changed for this drug. However, it was being used at lower than the recommended dose. There is a need for generating more evidence through improved pharmacovigilance activities and large-scale population-based prospective studies regarding the safety issues of pioglitazone, so as to make effectual risk-benefit analysis for its continual use in T2DM.

Possibility of Database Research as a Means of Pharmacovigilance in Japan Based on a Comparison with Sertraline Postmarketing Surveillance.

Science.gov (United States)

Hirano, Yoko; Asami, Yuko; Kuribayashi, Kazuhiko; Kitazaki, Shigeru; Yamamoto, Yuji; Fujimoto, Yoko

2018-05-01

Many pharmacoepidemiologic studies using large-scale databases have recently been utilized to evaluate the safety and effectiveness of drugs in Western countries. In Japan, however, conventional methodology has been applied to postmarketing surveillance (PMS) to collect safety and effectiveness information on new drugs to meet regulatory requirements. Conventional PMS entails enormous costs and resources despite being an uncontrolled observational study method. This study is aimed at examining the possibility of database research as a more efficient pharmacovigilance approach by comparing a health care claims database and PMS with regard to the characteristics and safety profiles of sertraline-prescribed patients. The characteristics of sertraline-prescribed patients recorded in a large-scale Japanese health insurance claims database developed by MinaCare Co. Ltd. were scanned and compared with the PMS results. We also explored the possibility of detecting signals indicative of adverse reactions based on the claims database by using sequence symmetry analysis. Diabetes mellitus, hyperlipidemia, and hyperthyroidism served as exploratory events, and their detection criteria for the claims database were reported by the Pharmaceuticals and Medical Devices Agency in Japan. Most of the characteristics of sertraline-prescribed patients in the claims database did not differ markedly from those in the PMS. There was no tendency for higher risks of the exploratory events after exposure to sertraline, and this was consistent with sertraline's known safety profile. Our results support the concept of using database research as a cost-effective pharmacovigilance tool that is free of selection bias . Further investigation using database research is required to confirm our preliminary observations. Copyright © 2018. Published by Elsevier Inc.

Transcranial Direct Current Stimulation: Five Important Issues We Aren’t Discussing (But Probably Should Be

Directory of Open Access Journals (Sweden)

Jared Cooney Horvath

2014-01-01

Full Text Available Transcranial Direct Current Stimulation (tDCS is a neuromodulatory device often publicized for its ability to enhance cognitive and behavioral performance. These enhancement claims, however, are predicated upon electrophysiological evidence and descriptions which are far from conclusive. In fact, a review of the literature reveals a number of important experimental and technical issues inherent with this device that are simply not being discussed in any meaningful manner. In this paper, we will consider five of these topics. The first, inter-subject variability, explores the extensive between- and within-group differences found within the tDCS literature and highlights the need to properly examine stimulatory response at the individual level. The second, intra-subject reliability, reviews the lack of data concerning tDCS response reliability over time and emphasizes the importance of this knowledge for appropriate stimulatory application. The third, sham stimulation and blinding, draws attention to the importance (yet relative lack of proper control and blinding practices in the tDCS literature. The fourth, motor and cognitive interference, highlights the often overlooked body of research that suggests typical behaviors and cognitions undertaken during or following tDCS can impair or abolish the effects of stimulation. Finally, the fifth, electric current influences, underscores several largely ignored variables (such as hair thickness and electrode attachments methods influential to tDCS electric current density and flow.Through this paper, we hope to increase awareness and start an ongoing dialogue of these important issues which speak to the efficacy, reliability, and mechanistic foundations of tDCS.

An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy

OpenAIRE

Richardson, Jonathan Luke; Stephens, Sally; Thomas, Simon Hugh Lynton; Jamry-Dziurla, Anna; de Jong-van den Berg, Lolkje; Zetstra - van der Woude, Priscilla; Laursen, Maja; Hliva, Valerie; Mt-Isa, Shahrul; Bourke, Alison; Dreyer, Nancy A; Blackburn, Stella CF

2016-01-01

BACKGROUND: Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized study sample can be recruited. OBJECTIVE: To compare the ability and cost-effectiveness of several direct-to-participant advertising methods for the recruitment of pregnant participants into a stu...

Role of Pharmacovigilance in India: An overview.

Science.gov (United States)

Suke, Sanvidhan G; Kosta, Prabhat; Negi, Harsh

2015-01-01

Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems. The research focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forums. The emerging trend in PV is to link premarketing data with human safety information observed in the post-marketing phase. The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. Adverse events reported by PV system potentially benefit to the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically. Hence, PV

Toward Maximizing Immunotherapy in Metastatic Castration-Resistant Prostate Cancer – Rationale for Combinatorial Approaches Using Chemotherapy

Energy Technology Data Exchange (ETDEWEB)

Slovin, Susan R., E-mail: slovins@mskcc.org [Genitourinary Oncology Service, Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan–Kettering Cancer Center, New York, NY (United States)

2012-05-30

Prostate cancer is particularly suited for active immunotherapy because of the expression of a distinctive number of antigens which are overexpressed on prostate cancer cells and cell lines. There is evidence in this disease that tumors promote immune tolerance starting early in the disease course. As such, chemotherapy, by suppressing tumors and activating immune system homeostatic mechanisms, may help overcome this tumor-induced immune tolerance. Sipuleucel-T which has recently been approved in the US, is an autologous cellular product immunotherapy that induces immune activity likely through activation of dendritic cells. This was associated with a survival benefit in the absence of significant toxicity. However, a post hoc analysis of phase III trial participants found a substantial survival benefit to receiving docetaxel some months after sipuleucel-T. However, another phase III immunotherapy trial combining a prostate cancer therapeutic vaccine GVAX plus docetaxel versus standard docetaxel therapy in advanced prostate cancer, observed a lower overall survival with the vaccine regimen. These trials highlight major unresolved questions concerning the optimum choice, dosing, and timing of chemotherapy relative to active immunotherapy and the overall merits of considering this approach. The ideal treatment approach remains unclear; advances in biomarker validation and trial design may likely improve our ability to assess biologic benefit irrespective of the development of true antitumor immunity.

Toward Maximizing Immunotherapy in Metastatic Castration-Resistant Prostate Cancer – Rationale for Combinatorial Approaches Using Chemotherapy

International Nuclear Information System (INIS)

Slovin, Susan R.

2012-01-01

Prostate cancer is particularly suited for active immunotherapy because of the expression of a distinctive number of antigens which are overexpressed on prostate cancer cells and cell lines. There is evidence in this disease that tumors promote immune tolerance starting early in the disease course. As such, chemotherapy, by suppressing tumors and activating immune system homeostatic mechanisms, may help overcome this tumor-induced immune tolerance. Sipuleucel-T which has recently been approved in the US, is an autologous cellular product immunotherapy that induces immune activity likely through activation of dendritic cells. This was associated with a survival benefit in the absence of significant toxicity. However, a post hoc analysis of phase III trial participants found a substantial survival benefit to receiving docetaxel some months after sipuleucel-T. However, another phase III immunotherapy trial combining a prostate cancer therapeutic vaccine GVAX plus docetaxel versus standard docetaxel therapy in advanced prostate cancer, observed a lower overall survival with the vaccine regimen. These trials highlight major unresolved questions concerning the optimum choice, dosing, and timing of chemotherapy relative to active immunotherapy and the overall merits of considering this approach. The ideal treatment approach remains unclear; advances in biomarker validation and trial design may likely improve our ability to assess biologic benefit irrespective of the development of true antitumor immunity.

Pharmacovigilance in oncology: evaluation of current practice and future perspectives.

Science.gov (United States)

Baldo, Paolo; De Paoli, Paolo

2014-10-01

Pharmacovigilance (PV), or drug safety monitoring, aims to improve patient safety through the detection and management of drug-related adverse reactions. It is implemented both by spontaneous reporting of adverse drug reactions (ADRs) and by careful detection of signals suggestive of drug toxicity. PV is an important clinical topic in clinical practice and pharmacotherapy, assuring the maintenance of a safe risk/benefit ratio throughout the commercial life cycle of a drug. We conducted a structured literature search on PubMed, Scopus, Cinahl and the Cochrane Library. We also performed manual searches in international databases of ADR individual reports to outline a structured profile on the topic. Our goal was to review key elements that affect safety monitoring of cancer drugs and their appropriate use, highlighting the strengths and weaknesses of PV in oncology. This paper provides an understanding of the methodologies used by PV in current clinical practice and particularly in cancer drug therapy; a focus upon reporting of ADRs by health professionals and patients; and a focus upon methods used by PV to detect new signals of risk/harm related to medicines utilization. To our knowledge, few articles focus upon the importance of PV and post-marketing surveillance of cancer drug therapies. Structured management of spontaneous reports of ADRs and data collection is essential to monitoring the safe use of drugs in this field in which pharmacotherapy is affected by high incidence of drug-related complications and by a narrow benefit/risk ratio. © 2014 John Wiley & Sons, Ltd.

[Position statements regarding usage of biosimilars of Epoetins. Position paper of the Société de néphrologie, Société francophone de dialyse, and Société de néphrologie pédiatrique].

Science.gov (United States)

Bouchet, Jean-Louis; Brunet, Philippe; Canaud, Bernard; Chanliau, Jacques; Combe, Christian; Deray, Gilbert; Houillier, Pascal; Kourilsky, Olivier; Ledneva, Elena; Niaudet, Patrick; Ortiz, Jean-Paul; Pavlovic, Mira; Ryckelynck, Jean-Philippe; Singlas, Eric; Verhelst, David

2009-02-01

The European patents for epoetin alpha recently expired. Biosimilars (i.e. "a medicine which is similar to a biological medicine that has already been authorized" [EMEA 2007]) of epoetins have thus been released on the market in Europe. Because of the complexity of the processes that are required to produce medicinal products containing biotechnology-derived proteins as active substances and to characterize the physicochemical properties of these compounds, the guidelines that have been developed for generic drugs cannot be used for approval of biosimilar products. The EMEA guidelines do not answer all questions that have been raised for the development of biosimilars, and in some cases, decisions will have to be taken at a national level. This is why the Society of Nephrology (Société de néphrologie), the French-speaking Society of Dialysis (Société francophone de dialyse) and the Pediatric Society of Nephrology (Société de néphrologie pédiatrique) established guidelines for the usage of biosimilar epoetins concerning approval, identification, substitution of an innovator drug, post-marketing surveillance, extension of indication and pharmacovigilance plan.

Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis.

Science.gov (United States)

Giofrè, Chiara; Scicchitano, Francesca; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; Leporini, Christian; Ventrice, Pasquale; Carbone, Claudia; Saullo, Francesca; Rende, Pierandrea; Menniti, Michele; Mumoli, Laura; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2013-12-01

Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports). Hospital doctors are the main source of this reporting (51.62%). Sorafenib (Nexavar(®)), the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83%) were more frequently reported, whereas the age groups "41-65" (39.07%) and "over 65" (27.9%) were the most affected. Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports), the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed.

The Targeting of Indoleamine 2,3 Dioxygenase -Mediated Immune Escape in Cancer

DEFF Research Database (Denmark)

Iversen, Trine Zeeberg; Andersen, Mads Hald; Svane, Inge Marie

2015-01-01

The era of immunotherapies was unleashed in 2010 with the Food and Drug Administration (FDA) approval of the first therapeutic vaccine sipuleucel-T as a standard treatment for metastatic prostate cancer. Next, the first immune-activating anticytotoxic lymphocyte antigen-4 (CTLA-4) antibody...... investigation in metastatic melanoma (MM) and non-small-cell lung cancer (NSCLC), and impressive clinical results are anticipated. Despite these successes, only a fraction of patients become clinical responders to therapy. Thus, to improve the selection of patients likely to respond, scrutinizing different...

Condições de implantação e operação da farmacovigilância na indústria farmacêutica no Estado de São Paulo, Brasil Pharmacovigilance implementation and operational conditions in the pharmaceutical industry in São Paulo State, Brazil

Directory of Open Access Journals (Sweden)

Márcia Sayuri Takamatsu Freitas

2007-01-01

Full Text Available O desenvolvimento de novos produtos farmacêuticos e as limitações dos ensaios clínicos controlados têm sido responsáveis pelo aumento das possibilidades de eventos adversos a medicamentos. A farmacovigilância é essencial para detectar e avaliar eventos adversos a medicamentos reduzindo riscos e evitando gastos excessivos em saúde pública. Este trabalho objetivou conhecer programas de farmacovigilância de indústrias farmacêuticas sediadas no Estado de São Paulo, Brasil. Os dados foram coletados utilizando-se questionário enviado eletronicamente a 105 empresas, das quais 41,9% retornaram. O motivo principal para implantação de programas foi atender exigências regulatórias e a principal justificativa para sua ausência foi produção limitada aos produtos fitoterápicos, ofici-nais e suplementos. Discutem-se as dificuldades para implantação dos programas, os recursos utilizados e características de alguns deles. Conclusões: (a a normatização é fonte de motivação para o aumento dos programas e do número de relatos mas é insuficiente sem esclarecimentos mais específicos; (b os resultados dependem de envolvimento multisetorial; (c o Serviço de Atendimento ao Consumidor é importante fonte de relatos; (d a estrutura da operação do serviço pode ser pouco dispendiosa em termos de recursos humanos e materiais.The development of new drugs and limitations of clinical trials have increased the likelihood of adverse drug events. Pharmacovigilance is essential to detect and evaluate adverse drug events, thereby reducing risks and avoiding excessive public health costs. This study focused on the pharmacovigilance programs in the pharmaceutical industry in São Paulo State, Brazil. Data were collected through questionnaires sent electronically to 105 companies, 41.9% of which responded. The main reason for implementing pharmacovigilance programs was to comply with legal requirements, while the main justification for its absence

Statistical Signal Process in R Language in the Pharmacovigilance Programme of India.

Science.gov (United States)

Kumar, Aman; Ahuja, Jitin; Shrivastava, Tarani Prakash; Kumar, Vipin; Kalaiselvan, Vivekanandan

2018-05-01

The Ministry of Health & Family Welfare, Government of India, initiated the Pharmacovigilance Programme of India (PvPI) in July 2010. The purpose of the PvPI is to collect data on adverse reactions due to medications, analyze it, and use the reference to recommend informed regulatory intervention, besides communicating the risk to health care professionals and the public. The goal of the present study was to apply statistical tools to find the relationship between drugs and ADRs for signal detection by R programming. Four statistical parameters were proposed for quantitative signal detection. These 4 parameters are IC 025 , PRR and PRR lb , chi-square, and N 11 ; we calculated these 4 values using R programming. We analyzed 78,983 drug-ADR combinations, and the total count of drug-ADR combination was 4,20,060. During the calculation of the statistical parameter, we use 3 variables: (1) N 11 (number of counts), (2) N 1. (Drug margin), and (3) N .1 (ADR margin). The structure and calculation of these 4 statistical parameters in R language are easily understandable. On the basis of the IC value (IC value >0), out of the 78,983 drug-ADR combination (drug-ADR combination), we found the 8,667 combinations to be significantly associated. The calculation of statistical parameters in R language is time saving and allows to easily identify new signals in the Indian ICSR (Individual Case Safety Reports) database.

Environmental issues in oil and gas operations in Yukon and in the N.W.T

International Nuclear Information System (INIS)

MacWilliam, A.G.

1999-01-01

Companies planning an expansion into the two territories ought to examine the way each territory deals with potential environmental issues such as spills, releases, contaminated sites and the reclamation of land. Recent legislation has provided each territory with a certain amount of autonomy, which includes the ability to oversee environmental protection. The Yukon, in particular, has considerable freedom in addressing environmental issues relating to oil and gas activities. Both territories are subject to the input and approval of the federal government and First Nations citizens where their respective interests or lands are involved. An overview is included of the regulation of environmental matters north of the 60th parallel. Although the expansion of oil and gas companies into the two territories 'north of 60' offers new opportunities, operators must consider the potential for environmental issues such as spills, releases, site contamination and reclamation of land. In the Yukon where the government has assumed jurisdiction to regulate oil and gas resources, it is implementing a comprehensive regime to deal with environmental issues, at first, in draft form. In contrast, in the N.W.T. the federal government retains considerable control over gas and oil rights and the consequent environmental issues, and, accordingly, it is essential to be aware of federal environmental regulations for the time being

Gentamicin nephrotoxicity: Animal experimental correlate with human pharmacovigilance outcome

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Olufunsho Awodele

2015-04-01

Full Text Available Background: National Agency for Food and Drugs Administration and Control (NAFDAC, which is responsible for pharmacovigilance activity in Nigeria, recently withdrew injection gentamicin 280 mg, used in the management of life-threatening and multidrug-resistant infections from circulation, due to reported toxicity. Thus, this study aimed to investigate the toxicity profile of the commonly used strengths (80 mg and 280 mg of gentamicin on kidney using animal models. Methods: Animals were divided into five groups of 16 rats each. For rats of groups 1 and 2, gentamicin (1.14 mg/kg each group was administered intramuscularly twice daily for 7 and 14 days, respectively, after which eight of them were sacrificed by cervical dislocation. Blood was collected via cardiac puncture and the kidneys were carefully removed and weighed immediately. The remaining eight animals were kept for reversibility study for another 7 and 14 days, respectively. For groups 3 and 4, gentamicin (4 mg/kg each group was administered as a single daily dose for 7 and 14 days, respectively, and eight animals from the groups were subjected to reversibility study for 7 and 14 days, respectively. Group 5, the control group animals, were given 10 ml/kg distilled water for 14 days. Histopathology of the kidneys, serum creatinine levels, and antioxidant enzyme activities were investigated. Results: Significant increase (p ≤ 0.001 in the level of creatinine of rats administered 4.0 mg/kg for 14 days was observed compared with all other groups. Significant (p ≤ 0.001 elevations in the lipid peroxidation in all gentamicin-administered animals and acute tubular necrosis in most of the gentamicin-administered animals were observed. Conclusion: Toxicity profile of gentamicin on the kidneys is dependent on both dose and duration of administration. The findings justify the decision made by NAFDAC to ban the use of high-dose inj. gentamicin 280 mg in Nigeria.

Experience of safety monitoring in the context of a prospective observational study of artemether-lumefantrine in rural Tanzania: lessons learned for pharmacovigilance reporting

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Kabanywanyi Abdunoor M

2010-07-01

Full Text Available Abstract Objectives To identify and implement strategies that help meet safety monitoring requirements in the context of an observational study for artemether-lumefantrine (AL administered as first-line treatment for uncomplicated malaria in rural Tanzania. Methods Pharmacovigilance procedures were developed through collaboration between the investigating bodies, the relevant regulatory authority and the manufacturer of AL. Training and refresher sessions on the pharmacovigilance system were provided for healthcare workers from local health facilities and field recorders of the Ifakara Health Demographic Surveillance System (IHDSS. Three distinct channels for identification of adverse events (AEs and serious adverse events (SAEs were identified and implemented. Passive reporting took place through IHDSS and health care facilities, starting in October 2007. The third channel was through solicited reporting that was included in the context of a survey on AL as part of the ALIVE (Artemether-Lumefantrine In Vulnerable patients: Exploring health impact study (conducted only in March-April 2008. Results Training was provided for 40 healthcare providers (with refresher training 18 months later and for six field recorders. During the period 1st September 2007 to 31st March 2010, 67 AEs were reported including 52 under AL, five under sulphadoxine-pyrimethamine, one under metakelfin, two after antibiotics; the remaining seven were due to anti-pyretic or anti-parasite medications. Twenty patients experienced SAEs; in 16 cases, a relation to AL was suspected. Six of the 20 cases were reported within 24 hours of occurrence. Discussion Safety monitoring and reporting is possible even in settings with weak health infrastructure. Reporting can be enhanced by regular and appropriate training of healthcare providers. SMS text alerts provide a practical solution to communication challenges. Conclusion Experience gained in this setting could help to improve

Don\\'t Ask, Don\\'t Tell: Ethical Issues Concerning Learning and ...

African Journals Online (AJOL)

Informed consent procedures and requirements must be clearly established and communicated. The learning and proficiency practices should be restricted to the staff that can truly benefit from the experience. The practice of 'don't ask, don't tell' is not an option. South African Journal of Family Practice Vol. 50 (4) 2008: pp.

A Survey on Pharmacovigilance Activities in ASEAN and Selected Non-ASEAN Countries, and the Use of Quantitative Signal Detection Algorithms.

Science.gov (United States)

Chan, Cheng Leng; Ang, Pei San; Li, Shu Chuen

2017-06-01

Most Countries have pharmacovigilance (PV) systems in place to monitor the safe use of health products. The process involves the detection and assessment of safety issues from various sources of information, communicating the risk to stakeholders and taking other relevant risk minimization measures. This study aimed to assess the PV status in Association of Southeast Asian Nation (ASEAN) countries, sources for postmarket safety monitoring, methods used for signal detection and the need for a quantitative signal detection algorithm (QSDA). Comparisons were conducted with centres outside ASEAN. A questionnaire was sent to all PV centres in ASEAN countries, as well as seven other countries, from November 2015 to June 2016. The questionnaire was designed to collect information on the status of PV, with a focus on the use of a QSDA. Data were collected from nine ASEAN countries and seven other countries. PV activities were conducted in all these countries, which were at different stages of development. In terms of adverse drug reaction (ADR) reports, the average number received per year ranged from 3 to 50,000 reports for ASEAN countries and from 7000 to 1,103,200 for non-ASEAN countries. Thirty-three percent of ASEAN countries utilized statistical methods to help detect signals from ADR reports compared with 100% in the other non-ASEAN countries. Eighty percent agreed that the development of a QSDA would help in drug signal detection. The main limitation identified was the lack of knowledge and/or lack of resources. Spontaneous ADR reports from healthcare professionals remains the most frequently used source for safety monitoring. The traditional method of case-by-case review of ADR reports prevailed for signal detection in ASEAN countries. As the reports continue to grow, the development of a QSDA would be useful in helping detect safety signals.

A celebration of mechanics: from nano to macro. The J. Michael T. Thompson Festschrift issue.

Science.gov (United States)

Elishakoff, Isaac

2013-06-28

This Theme Issue is dedicated to the topic 'Mechanics: from nano to macro' and marks the 75th birthday of Dr J. Michael T. Thompson, Fellow of the Royal Society, whose current affiliations are as follows: (i) Honorary Fellow, Department of Applied Mathematics and Theoretical Physics, Centre for Mathematical Sciences, University of Cambridge; (ii) Emeritus Professor of Nonlinear Dynamics, Department of Civil, Environmental and Geomatic Engineering, University College London; and (iii) Professor of Theoretical and Applied Dynamics (Distinguished Sixth Century Chair, part-time), University of Aberdeen. He also serves as Chairman of the Board of Directors at ES-Consult (consulting engineers) in Copenhagen, Denmark. The pertinent question that arises from the very start is: should we first salute Michael and then describe the Theme Issue, or vice versa? Indeed, according to Blaise Pascal (1623-1662), the last thing one discovers in composing a work is what to put first. I would like to take the liberty of deviating from the tradition of the Philosophical Transactions and start with the tribute to Michael; after all he is the prime cause of this Theme Issue.

Utilizing social media data for pharmacovigilance: A review.

Science.gov (United States)

Sarker, Abeed; Ginn, Rachel; Nikfarjam, Azadeh; O'Connor, Karen; Smith, Karen; Jayaraman, Swetha; Upadhaya, Tejaswi; Gonzalez, Graciela

2015-04-01

Automatic monitoring of Adverse Drug Reactions (ADRs), defined as adverse patient outcomes caused by medications, is a challenging research problem that is currently receiving significant attention from the medical informatics community. In recent years, user-posted data on social media, primarily due to its sheer volume, has become a useful resource for ADR monitoring. Research using social media data has progressed using various data sources and techniques, making it difficult to compare distinct systems and their performances. In this paper, we perform a methodical review to characterize the different approaches to ADR detection/extraction from social media, and their applicability to pharmacovigilance. In addition, we present a potential systematic pathway to ADR monitoring from social media. We identified studies describing approaches for ADR detection from social media from the Medline, Embase, Scopus and Web of Science databases, and the Google Scholar search engine. Studies that met our inclusion criteria were those that attempted to extract ADR information posted by users on any publicly available social media platform. We categorized the studies according to different characteristics such as primary ADR detection approach, size of corpus, data source(s), availability, and evaluation criteria. Twenty-two studies met our inclusion criteria, with fifteen (68%) published within the last two years. However, publicly available annotated data is still scarce, and we found only six studies that made the annotations used publicly available, making system performance comparisons difficult. In terms of algorithms, supervised classification techniques to detect posts containing ADR mentions, and lexicon-based approaches for extraction of ADR mentions from texts have been the most popular. Our review suggests that interest in the utilization of the vast amounts of available social media data for ADR monitoring is increasing. In terms of sources, both health

Utilizing Social Media Data for Pharmacovigilance: A Review

Science.gov (United States)

Sarker, Abeed; Ginn, Rachel; Nikfarjam, Azadeh; O’Connor, Karen; Smith, Karen; Jayaraman, Swetha; Upadhaya, Tejaswi; Gonzalez, Graciela

2015-01-01

Objective Automatic monitoring of Adverse Drug Reactions (ADRs), defined as adverse patient outcomes caused by medications, is a challenging research problem that is currently receiving significant attention from the medical informatics community. In recent years, user-posted data on social media, primarily due to its sheer volume, has become a useful resource for ADR monitoring. Research using social media data has progressed using various data sources and techniques, making it difficult to compare distinct systems and their performances. In this paper, we perform a methodical review to characterize the different approaches to ADR detection/extraction from social media, and their applicability to pharmacovigilance. In addition, we present a potential systematic pathway to ADR monitoring from social media. Methods We identified studies, describing approaches for ADR detection from social media from the Medline, Embase, Scopus and Web of Science databases, and the Google Scholar search engine. Studies that met our inclusion criteria were those that attempted to utilize ADR information posted by users on any publicly available social media platform. We categorized the studies into various dimensions such as primary ADR detection approach, size of data, source(s), availability, evaluation criteria, and so on. Results Twenty-two studies met our inclusion criteria, with fifteen (68.2%) published within the last two years. The survey revealed a clear trend towards the usage of annotated data with eleven of the fifteen (73.3%) studies published in the last two years relying on expert annotations. However, publicly available annotated data is still scarce, and we found only six (27.3%) studies that made the annotations used publicly available, making system performance comparisons difficult. In terms of algorithms, supervised classification techniques to detect posts containing ADR mentions, and lexicon-based approaches for extraction of ADR mentions from texts have been

Dendritic cell-based vaccination in cancer: therapeutic implications emerging from murine models

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Soledad eMac Keon

2015-05-01

Full Text Available Dendritic cells (DCs play a pivotal role in the orchestration of immune responses, and are thus key targets in cancer vaccine design. Since the 2010 FDA approval of the first cancer DC-based vaccine (Sipuleucel T there has been a surge of interest in exploiting these cells as a therapeutic option for the treatment of tumors of diverse origin. In spite of the encouraging results obtained in the clinic, many elements of DC-based vaccination strategies need to be optimized. In this context, the use of experimental cancer models can help direct efforts towards an effective vaccine design. This paper reviews recent findings in murine models regarding the antitumoral mechanisms of DC-based vaccination, covering issues related to antigen sources, the use of adjuvants and maturing agents, and the role of DC subsets and their interaction in the initiation of antitumoral immune responses. The summary of such diverse aspects will highlight advantages and drawbacks in the use of murine models, and contribute to the design of successful DC-based translational approaches for cancer treatment.

Ontology-based Vaccine and Drug Adverse Event Representation and Theory-guided Systematic Causal Network Analysis toward Integrative Pharmacovigilance Research.

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He, Yongqun

2016-06-01

Compared with controlled terminologies ( e.g. , MedDRA, CTCAE, and WHO-ART), the community-based Ontology of AEs (OAE) has many advantages in adverse event (AE) classifications. The OAE-derived Ontology of Vaccine AEs (OVAE) and Ontology of Drug Neuropathy AEs (ODNAE) serve as AE knowledge bases and support data integration and analysis. The Immune Response Gene Network Theory explains molecular mechanisms of vaccine-related AEs. The OneNet Theory of Life treats the whole process of a life of an organism as a single complex and dynamic network ( i.e. , OneNet). A new "OneNet effectiveness" tenet is proposed here to expand the OneNet theory. Derived from the OneNet theory, the author hypothesizes that one human uses one single genotype-rooted mechanism to respond to different vaccinations and drug treatments, and experimentally identified mechanisms are manifestations of the OneNet blueprint mechanism under specific conditions. The theories and ontologies interact together as semantic frameworks to support integrative pharmacovigilance research.

Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

Energy Technology Data Exchange (ETDEWEB)

Gamboa, Maryelle Moreira Lima; Roesch, Heveline Rayane Moura; Lemos, Vanessa Pinheiro Amaral, E-mail: maryellelg@hotmail.com [PPG BioSaude, Universidade Luterana do Brasil, Canoas, RS (Brazil); Rocha, Bruna Oliveira [Faculty of Biology, Universidade Luterana do Brasil, Canoas, RS (Brazil); Santos-Oliveira, Ralph [Institute of Radiopharmacy Research, Universidade Estadual da Zona Oeste, Rio de Janeiro, RJ (Brazil)

2014-04-15

Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. >From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. (author)

Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

International Nuclear Information System (INIS)

Gamboa, Maryelle Moreira Lima; Roesch, Heveline Rayane Moura; Lemos, Vanessa Pinheiro Amaral; Rocha, Bruna Oliveira; Santos-Oliveira, Ralph

2014-01-01

Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. >From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. (author)

Facilitating adverse drug event detection in pharmacovigilance databases using molecular structure similarity: application to rhabdomyolysis

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Vilar, Santiago; Harpaz, Rave; Chase, Herbert S; Costanzi, Stefano; Rabadan, Raul

2011-01-01

Background Adverse drug events (ADE) cause considerable harm to patients, and consequently their detection is critical for patient safety. The US Food and Drug Administration maintains an adverse event reporting system (AERS) to facilitate the detection of ADE in drugs. Various data mining approaches have been developed that use AERS to detect signals identifying associations between drugs and ADE. The signals must then be monitored further by domain experts, which is a time-consuming task. Objective To develop a new methodology that combines existing data mining algorithms with chemical information by analysis of molecular fingerprints to enhance initial ADE signals generated from AERS, and to provide a decision support mechanism to facilitate the identification of novel adverse events. Results The method achieved a significant improvement in precision in identifying known ADE, and a more than twofold signal enhancement when applied to the ADE rhabdomyolysis. The simplicity of the method assists in highlighting the etiology of the ADE by identifying structurally similar drugs. A set of drugs with strong evidence from both AERS and molecular fingerprint-based modeling is constructed for further analysis. Conclusion The results demonstrate that the proposed methodology could be used as a pharmacovigilance decision support tool to facilitate ADE detection. PMID:21946238

Safety of Factor XIII Concentrate: Analysis of More than 20 Years of Pharmacovigilance Data

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Solomon, Cristina; Korte, Wolfgang; Fries, Dietmar; Pendrak, Inna; Joch, Christine; Gröner, Albrecht; Birschmann, Ingvild

2016-01-01

Background Plasma-derived factor XIII (FXIII) concentrate is an effective treatment for FXIII deficiency. We describe adverse drug reactions (ADRs) reported during pharmacovigilance monitoring of Fibrogammin®/Corifact® and review published safety data. Methods Postmarketing safety reports recorded by CSL Behring from June 1993 to September 2013 were analyzed. Clinical studies published during the same period were also reviewed. Results Commercial data indicated that 1,653,450,333 IU FXIII concentrate were distributed over the review period, equivalent to 1,181,036 doses for a 70 kg patient. 75 cases were reported (one/15,700 standard doses or 22,046,000 IU). Reports of special interest included 12 cases of possible hypersensitivity reactions (one/98,400 doses or 137,787,500 IU), 7 with possible thromboembolic events (one/168,700 doses or 236,207,200 IU), 5 of possible inhibitor development (one/236,200 doses or 330,690,100 IU), and 20 of possible pathogen transmission (one/59,100 doses or 82,672,500 IU). 19 pathogen transmission cases involved viral infection; 4 could not be analyzed due to insufficient data, but for all others a causal relationship to the product was assessed as unlikely. A review of published literature revealed a similar safety profile. Conclusion Assessment of ADRs demonstrated that FXIII concentrate carries a low risk of ADRs across various clinical situations, suggesting a favorable safety profile. PMID:27781024

A research framework for pharmacovigilance in health social media: Identification and evaluation of patient adverse drug event reports.

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Liu, Xiao; Chen, Hsinchun

2015-12-01

Social media offer insights of patients' medical problems such as drug side effects and treatment failures. Patient reports of adverse drug events from social media have great potential to improve current practice of pharmacovigilance. However, extracting patient adverse drug event reports from social media continues to be an important challenge for health informatics research. In this study, we develop a research framework with advanced natural language processing techniques for integrated and high-performance patient reported adverse drug event extraction. The framework consists of medical entity extraction for recognizing patient discussions of drug and events, adverse drug event extraction with shortest dependency path kernel based statistical learning method and semantic filtering with information from medical knowledge bases, and report source classification to tease out noise. To evaluate the proposed framework, a series of experiments were conducted on a test bed encompassing about postings from major diabetes and heart disease forums in the United States. The results reveal that each component of the framework significantly contributes to its overall effectiveness. Our framework significantly outperforms prior work. Published by Elsevier Inc.

Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada.

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Thibault B Ali

Full Text Available This survey analyzes two national pharmacovigilance databases in order to determine the major adverse reactions observed with the use of cholinesterase inhibitors in dementia. We conducted a statistical analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS and the Canada Vigilance Adverse Reaction Database (CVARD concerning the side effects of cholinesterase inhibitors. The statistics calculated for each adverse event were the frequency and the reporting odds ratios (ROR. A total of 9877 and 2247 reports were extracted from the FAERS and CVARD databases, respectively. A disproportionately higher frequency of reports of death as an adverse event for rivastigmine, compared to the other acetylcholinesterase inhibiting drugs, was observed in both the FAERS (ROR = 3.42; CI95% = 2.94-3.98; P<0.0001 and CVARD (ROR = 3.67; CI95% = 1.92-7.00; P = 0.001 databases. While cholinesterase inhibitors remain to be an important therapeutic tool against Alzheimer's disease, the disproportionate prevalence of fatal outcomes with rivastigmine compared with alternatives should be taken into consideration.

Adverse drug reaction monitoring of newer oral anti diabetic drugs – a pharmacovigilance perspective

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Ankita Bhattacharjee

2016-04-01

Full Text Available Objective: To monitor and evaluate adverse drug reactions (ADRs of newer oral anti-diabetic drugs in type II diabetics by spontaneous/solicited ADR monitoring.Material and methods: Two hundred and thirty two diabetic patients on newer oral antidiabetic drugs were evaluated prospectively in a cross-sectional study over a period of eighteen months. All patients were followed up for ADRs which were evaluated for incidence, frequency, severity and causality. ADR severity was graded according to University of Virginia Health System Adverse Drug Reaction Reporting program criteria and causality assessment was done using WHO-UMC scale.Results: 190 out of 232 patients (42 patients lost to follow up were evaluated. ADRs were observed in 34 cases (17.9%. Most common ADRs were gastrointestinal (44.2% followed by musculoskeletal (17.6%, metabolic (14.7%, infections (5.9% and others (17.6%. The maximal frequency of ADRs was seen with sitagliptin (6.4% followed by vildagliptin(3.8%, saxagliptin(2.7%, saroglitazar(2.1%, linagliptin(1.6%, canagliflozin(1.6%. 25(73.5%, 8(23.5% and 1(3% ADRs were mild, moderate and severe respectively. 24(70% ADRs were classified as possible, 9(27% probable and 1(3% unlikely on causality assessment. Conclusion: Newer oral antidiabetic drugs like gliptins and SGLT-2 inhibitors have potential to cause ADRs. Gastro-intestinal, musculoskeletal, metabolic were most common ADRs. Active pharmacovigilance should be carried out for risk identification and management. 

Patterns of adverse drug reaction signals in NAFDAC Pharmacovigilance activities from September to November, 2014.

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Awodele, Olufunsho; Ibrahim, Ali; Orhii, Paul

2016-03-16

Adverse drug reaction signals are reported information on possible causal relationships between an adverse event and a drug. The National Pharmacovigilance Centre (NPC) in Nigeria has over 3,000 reported adverse drug reaction cases which have been adequately entered into the ADR data bank. Data mining of ADR reports from September to November, 2014 were carried out in this present study with the intention to describe the pattern of ADRs and generate possible signals. A total of about 100 reported cases with arrays of adverse drug reactions were reported between September and November, 2014 and the data were analyzed using SPSS version 17. Efavirenz/Tenofovir/Lamivudine combination was the highest reported drugs (24.2%) while efavirenz alone was reported in 8 times (8.8%) and HIV (63.3%) was the highest reported indication of drug use. Efavirenz caused central nervous system adverse reactions as revealed in the ADRs analyses. Zidovudine/Lamivudine/Nevirapine combination in concomitant use with Cotrimoxazole were reported 8 times with generalized maculopapular rashes on the trunk with some area of hyper pigmentation with intense itching documented twice and big/swollen rashes all over the faces. Zidovudine was also reported four times to cause severe anaemia. More surveillance is advocated so as to ascertain the consistency of the observed ADRs and thereafter establish appropriate signals.

Aplicación de la minería de datos al Sistema Cubano de Farmacovigilancia Application of data mining to the Cuban Pharmacovigilance System

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Omar Calzadilla Fernández de Castro

2007-12-01

Full Text Available En el año 1999, se crea la Unidad Nacional Coordinadora de Farmacovigilancia, la cual funciona como el órgano técnico-científico que desarrolla la política de vigilancia de seguridad de medicamentos del Ministerio de Salud Pública e integra las actividades de los centros provinciales y de otros programas concertados de farmacovigilancia en un sistema único. Entre sus funciones más relevantes se encuentran la de definir, diseñar y desarrollar los sistemas de información; administrar la base de datos nacional; depurar y validar la información contenida en ella; y realizar y coordinar estudios científicos sobre la seguridad de los medicamentos; así como elaborar informes para las autoridades sanitarias y el Sistema Nacional de Salud. En este sistema existe la necesidad de utilizar herramientas de análisis, por lo que se trazó el objetivo de definir, diseñar y desarrollar los sistemas de tratamiento de la información y administrar la base de datos nacional "VigiBaseCuba". Aplicando una serie de transformaciones, validaciones y la adecuación de la metodología CRISP-DM para la elaboración de proyectos de minería de datos, se conformó la base de datos nacional, en un sistema de gestión de bases de datos relacional con los registros de las notificaciones de sospechas de reacciones adversas a los medicamentos y un proceso de descubrimiento de conocimiento que permite gestionar eficazmente la seguridad de los medicamentos, así como desarrollar aplicaciones para la visualización de las señales de reacciones adversas y su evoluciónIn 1999, The National Coordinating Unit of Pharmacovigilance was created. It works as a scientific and technical agency that develops the drug safety surveillance policy of the Ministry of Public Health, and integrates the activities of the provincial centres and other pharmacovigilance programs in a unique system. Some of its most important functions are to define, design and develop the information

Tank characterization report for single-shell tanks 241-T-201, 241-T-202, 241-T-203, and 241-T-204

International Nuclear Information System (INIS)

Simpson, B.C.

1998-01-01

A major function of the Tank Waste Remediation System (TWRS) is to characterize waste in support of waste management and disposal activities at the Hanford Site. Analytical data from sampling and analysis, in addition to other available information about a tank are compiled and maintained in a tank characterization report (TCR). This report and its appendices serve as the TCR for the single-shell tank series consisting of 241-T-201, -T-202, -T-203, and -T-204. The objectives of this report are: (1) to use characterization data in response to technical issues associated with T-200 series tank waste and (2) to provide a standard characterization of this waste in terms of a best-basis inventory estimate. Section 2.0 summarizes the response to technical issues, Section 3.0 shows the best-basis inventory estimate, Section 4.0 makes recommendations about the safety status of the tank and additional sampling needs. The appendices contain supporting data and information. Appendix A contains historical information for 241-T-201 to T-204, including surveillance information, records pertaining to waste transfers and tank operations, and expected tank contents derived from a process knowledge-based computer program. Appendix B summarizes sampling events, sample data obtained before 1989, and the most current sampling results. Appendix C reports the statistical analysis and numerical manipulation of data used in issue resolution. Appendix D contains the evaluation to establish the best-basis for the inventory estimate and the statistical analysis performed for this evaluation. Appendix E is a bibliography that resulted from an in-depth literature search of all known information sources applicable to tanks 241-T-201, -T-202, -T-203, and -T-204. The reports listed in Appendix E are available in the Tank Characterization and Safety Resource Center

Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

Directory of Open Access Journals (Sweden)

Maryelle Moreira Lima Gamboa

2014-04-01

Full Text Available Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ or positrons emitter (β+, linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64. In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs.

T Chandrashekar

Indian Academy of Sciences (India)

Home; Journals; Bulletin of Materials Science. T Chandrashekar. Articles written in Bulletin of Materials Science. Volume 24 Issue 4 August 2001 pp 345-353 Metals and Alloys. Effects and mechanisms of grain refinement in aluminium alloys · K T Kashyap T Chandrashekar · More Details Abstract Fulltext PDF.

Simultaneous acquisition for T2 -T2 Exchange and T1 -T2 correlation NMR experiments

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Montrazi, Elton T.; Lucas-Oliveira, Everton; Araujo-Ferreira, Arthur G.; Barsi-Andreeta, Mariane; Bonagamba, Tito J.

2018-04-01

The NMR measurements of longitudinal and transverse relaxation times and its multidimensional correlations provide useful information about molecular dynamics. However, these experiments are very time-consuming, and many researchers proposed faster experiments to reduce this issue. This paper presents a new way to simultaneously perform T2 -T2 Exchange and T1 -T2 correlation experiments by taking the advantage of the storage time and the two steps phase cycling used for running the relaxation exchange experiment. The data corresponding to each step is either summed or subtracted to produce the T2 -T2 and T1 -T2 data, enhancing the information obtained while maintaining the experiment duration. Comparing the results from this technique with traditional NMR experiments it was possible to validate the method.

[Summarizing of medicinal alerts in Ivory Coast from 2001 till 2010].

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N'Guessan-Irié, Amenan Geneviève; Yavo, Jean-Claude; Guillaume Amari, Antoine Serge; Yapi, Ange Désiré

2012-01-01

STUDY'S AIM: This study aims a more efficient follow-up of the safety of medicines with human usage on the Ivory Coast territory. The structure responsible for pharmacovigilance in Ivory Coast i.e. DPM listed the medicinal alerts from 2001 till 2010. It emerges 237 medicinal alerts among which 145 stops of marketing, 55 withdrawals of lots, 33 information notes and 4 levying of suspension of medicines. These alerts result mainly from pharmaceutical companies (49%) and the French Drug Agency or ANSM (ex-Afssaps) (43%). They mainly concern drugs of infectious target (22%) and pneumology (18%) and their motivations are so much industrial with mainly commercial reasons (27%) as of pharmacovigilance dominated by unfavorable profit/risk connections. These results constitute an important database for the survey of the medicines market in Ivory Coast and an additional motivation to accelerate the implementation of a real national center of pharmacovigilance. © 2012 Société Française de Pharmacologie et de Thérapeutique.

Technical issues and conservation conditions of medicines in the primary health care of the Brazilian Unified Health System

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Costa, Ediná Alves; Araújo, Patrícia Sodré; Pereira, Marcelo Tavares; Souto, Ana Cristina; Souza, Gisélia Santana; Guerra, Augusto Afonso; Acurcio, Francisco de Assis; Guibu, Ione Aquemi; Alvares, Juliana; Costa, Karen Sarmento; Karnikowski, Margô Gomes de Oliveira; Soeiro, Orlando Mario; Leite, Silvana Nair

2017-01-01

ABSTRACT OBJECTIVE To characterize the technical issues and conditions of medicines conservation in Primary Health Care of Brazilian regions, responsible for pharmacy/dispensing unit profile; environmental, storage, and dose fractioning conditions; inventory control and waste management; fire and electrical failure safety items; transportation problems; advertising regulation; and pharmacovigilance. METHODS This article is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços (National Survey on Access, Use and Promotion of Rational Use of Medicines – Services)–, a cross-sectional and exploratory study, of evaluative nature, consisting of an information survey within a representative sample of municipalities, stratified by Brazilian regions, which constitute the study domains, and a sample of Primary Health Care services. Pharmaceutical services (PS) were directly observed with photographic record and face-to-face interviews with those responsible for the dispensing of medicines and over the telephone with those responsible for pharmaceutical services. Data were processed with the SPSS® software version 21. RESULTS The investigated dimensions showed relevant deficiencies and inequalities between the regions, generally more favorable in the Southeast and Midwest regions and weaker in the Northeast and North regions. We verified non-compliance with technical requirements and conditions essential to the conservation of medicines, which may interfere with the maintenance of stability and, thus, on their quality, efficacy, and safety. The regulation of advertising/promotion of medicines is still incipient and there is some progress in the structuring of mechanisms regarding pharmacovigilance. CONCLUSIONS The sanitary situation of medicines in Brazilian Primary Health Care is alarming due to the violation of the specific sanitary legislation for dispensing establishments and due to a wide range of

IJIMAI Editors Note - Vol. 4 Issue 3

Directory of Open Access Journals (Sweden)

Vicente García-Díaz

2017-03-01

This Special Issue tries to show some of the latest researches related to IoT with special emphasis on the basic components of IoT, some of the major applications in which researchers and practitioners are working and especially in aspects related to security, one of the main areas of research related to IoT, with a special emphasis on cloud-based systems. Next, I present a summary of the works that are included in this special issue.

Gingival bleeding, a possible "serious" adverse drug reaction: An observational study in the French PharmacoVigilance Database.

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Bondon-Guitton, Emmanuelle; Mourgues, Thibaut; Rousseau, Vanessa; Cousty, Sarah; Cottin, Judith; Drablier, Guillaume; Micallef, Joëlle; Montastruc, Jean-Louis

2017-09-01

Antithrombotic drugs are known to increase the risk of gingival bleeding because they affect coagulation. However, other drugs could also be involved in gingival bleeding. We performed a pharmacoepidemiological study to identify the drugs most frequently "suspected" in the occurrence of gingival bleeding. We selected reports of "gingival bleeding" from 1 January 1985 to 30 September 2014 in the French PharmacoVigilance Database. Among 523,808 reports of adverse drug reactions, we identified 454 reports of gingival bleeding (0.09%). Most of them were "serious" (58.4%) and occurred in females (54.6%). The frequency of gingival bleeding increased with age. The most frequently "suspected" drugs were antithrombotics (67.8%), particularly fluindione. Other drugs frequently involved were furosemide followed by paracetamol, amiodarone, amoxicillin, paroxetine, ketoprofen, zolpidem, enalapril and ramipril. Thirty-nine reports involved a drug-drug interaction with antithrombotics, mainly with anti-infectives. Gingival bleeding can be an adverse drug reaction, often "serious" and rarely fatal. Patients older than 50 years and women are particularly at risk. Among drugs known to increase the risk of gingival bleeding, the most frequently involved were fluindione, furosemide, paracetamol, amiodarone, amoxicillin, paroxetine or ketoprofen. We also identified signal for drugs not usually known to be involved in bleeding, like zolpidem, enalapril or ramipril. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Systemic therapy in men with metastatic castration-resistant prostate cancer:American Society of Clinical Oncology and Cancer Care Ontario clinical practice guideline.

Science.gov (United States)

Basch, Ethan; Loblaw, D Andrew; Oliver, Thomas K; Carducci, Michael; Chen, Ronald C; Frame, James N; Garrels, Kristina; Hotte, Sebastien; Kattan, Michael W; Raghavan, Derek; Saad, Fred; Taplin, Mary-Ellen; Walker-Dilks, Cindy; Williams, James; Winquist, Eric; Bennett, Charles L; Wootton, Ted; Rumble, R Bryan; Dusetzina, Stacie B; Virgo, Katherine S

2014-10-20

To provide treatment recommendations for men with metastatic castration-resistant prostate cancer (CRPC). The American Society of Clinical Oncology and Cancer Care Ontario convened an expert panel to develop evidence-based recommendations informed by a systematic review of the literature. When added to androgen deprivation, therapies demonstrating improved survival, improved quality of life (QOL), and favorable benefit-harm balance include abiraterone acetate/prednisone, enzalutamide, and radium-223 ((223)Ra; for men with predominantly bone metastases). Improved survival and QOL with moderate toxicity risk are associated with docetaxel/prednisone. For asymptomatic/minimally symptomatic men, improved survival with unclear QOL impact and low toxicity are associated with sipuleucel-T. For men who previously received docetaxel, improved survival, unclear QOL impact, and moderate to high toxicity risk are associated with cabazitaxel/prednisone. Modest QOL benefit (without survival benefit) and high toxicity risk are associated with mitoxantrone/prednisone after docetaxel. No benefit and excess toxicity are observed with bevacizumab, estramustine, and sunitinib. Continue androgen deprivation (pharmaceutical or surgical) indefinitely. Abiraterone acetate/prednisone, enzalutamide, or (223)Ra should be offered; docetaxel/prednisone should also be offered, accompanied by discussion of toxicity risk. Sipuleucel-T may be offered to asymptomatic/minimally symptomatic men. For men who have experienced progression with docetaxel, cabazitaxel may be offered, accompanied by discussion of toxicity risk. Mitoxantrone may be offered, accompanied by discussion of limited clinical benefit and toxicity risk. Ketoconazole or antiandrogens (eg, bicalutamide, flutamide, nilutamide) may be offered, accompanied by discussion of limited known clinical benefit. Bevacizumab, estramustine, and sunitinib should not be offered. There is insufficient evidence to evaluate optimal sequences or

Pharmacovigilance Evaluation of the Association Between DPP-4 Inhibitors and Heart Failure: Stimulated Reporting and Moderation by Drug Interactions.

Science.gov (United States)

Fadini, Gian Paolo; Sarangdhar, Mayur; Avogaro, Angelo

2018-04-01

In the SAVOR-TIMI trial, the risk of heart failure (HF) was increased by 27% in T2D patients randomized to the dipeptidyl peptidase-4 inhibitor (DPP4i) saxagliptin. Other studies have provided inconsistent results regarding this association. Herein, we performed a pharmacovigilance analysis of the rate of HF associated with DPP4is, focusing on stimulated reporting and moderation by drug-drug interactions. We mined the FDA adverse event (AE) reporting system (FAERS) from 2004q1 to 2017q3, including a total of 9906,642 AE reports. Rates (/1000 reports) of HF within the reports for DPP4is and reports for other antidiabetic drugs were calculated for the period up to 2013q3 (date of publication of the SAVOR-TIMI trial results) and from 2013q4 to 2017q3. Analyses were refined by filtering according to therapeutic area, concomitant diseases and drugs, and competing AEs. The rate of HF among the AE reports filed for DPP4is significantly increased after 2013q3, especially for saxagliptin. When compared to non-insulin non-glitazone antidiabetic drugs, the proportional reporting ratio (PRR) of HF for DPP4is was 0.62 (95% CI 0.56-0.68) up to 2013q3 and 2.12 (95% CI 1.96-2.28) from 2013q4 to 2017q3. This stimulated reporting was consistent in subanalyses based on the presence/absence of cardiac disorders and after controlling for competing AEs. The rate of HF among AE reports for DPP4is was modestly moderated by the concomitant use of metformin (- 15%) and strongly moderated by the concomitant use of SGLT2 inhibitors (- 63%), even after excluding competing AEs. Within the FAERS, the association between HF and DPP4is was biased by stimulated reporting, implying that the publication of the SAVOR-TIMI trial and the subsequent regulatory warnings primed clinicians to report HF events in DPP4i users as drug-related AEs. The rate of HF associated with DPP4is was moderated when they were used in combination with SGLT2 inhibitors.

Climate Change: Issues in the Science and Its Use

Science.gov (United States)

2009-07-01

Thomas Lovejoy , Mr. Stuart Eizenstat, and Ms. Stephanie Meeks. Hearing...I N S T I T U T E F O R D E F E N S E A N A LY S E S IDA Document D-3904 Log: H 09-000863 July 2009 Climate Change: Issues in the Science and...challenges. I N S T I T U T E F O R D E F E N S E A N A LY S E S IDA Document D-3904 Climate Change: Issues in the Science and Its Use

Novel cancer immunotherapy agents with survival benefit: recent successes and next steps

Science.gov (United States)

Sharma, Padmanee; Wagner, Klaus; Wolchok, Jedd D.; Allison, James P.

2012-01-01

The US Food and Drug Administration (FDA) recently approved two novel immunotherapy agents, sipuleucel-T and ipilimumab, which showed a survival benefit for patients with metastatic prostate cancer and melanoma, respectively. The mechanisms by which these agents provide clinical benefit are not completely understood. However, knowledge of these mechanisms will be crucial for probing human immune responses and tumour biology in order to understand what distinguishes responders from non-responders. The following next steps are necessary: first, the development of immune-monitoring strategies for the identification of relevant biomarkers; second, the establishment of guidelines for the assessment of clinical end points; and third, the evaluation of combination therapy strategies to improve clinical benefit. PMID:22020206

Patient-centered pharmacovigilance: A review | Saleh | Tropical ...

African Journals Online (AJOL)

Tropical Journal of Pharmaceutical Research. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 17, No 1 (2018) >. Log in or Register to get access to full text downloads.

T Chandrasekhar

Indian Academy of Sciences (India)

Home; Journals; Resonance – Journal of Science Education. T Chandrasekhar. Articles written in Resonance – Journal of Science Education. Volume 7 Issue 8 August 2002 pp 29-39 General Article. The Mystery and Beauty of Total Solar Eclipses · T Chandrasekhar · More Details Fulltext PDF ...

t prakash

Indian Academy of Sciences (India)

Home; Journals; Bulletin of Materials Science. T PRAKASH. Articles written in Bulletin of Materials Science. Volume 41 Issue 2 April 2018 pp 40. Chemical synthesis of highly size-confined triethylamine-capped TiO 2 nanoparticles and its dye-sensitized solar cell performance · T PRAKASH M NAVANEETHAN J ARCHANA ...

T Ramasami

Indian Academy of Sciences (India)

Home; Journals; Resonance – Journal of Science Education. T Ramasami. Articles written in Resonance – Journal of Science Education. Volume 19 Issue 10 October 2014 pp 887-899 General Article. Yelavarthy Nayudamma: Scientist, Leader, and Mentor Extraordinary · J Raghava Rao T Ramasami · More Details Fulltext ...

T Machappa

Indian Academy of Sciences (India)

Home; Journals; Bulletin of Materials Science. T Machappa. Articles written in Bulletin of Materials Science. Volume 35 Issue 1 February 2012 pp 75-81. Humidity sensing behaviour of polyaniline/magnesium chromate (MgCrO4) composite · T Machappa M V N Ambika Prasad · More Details Abstract Fulltext PDF.

Fuel cycle integration issues associated with P/T technology

International Nuclear Information System (INIS)

Michaels, G.E.; Ludwig, S.B.

1992-01-01

The three primary interfaces between a generic partitioning and transmutation (P/T) technology and the existing United States fuel cycle are the light-water reactor (LWR) spent fuel inventory, the reprocessed uranium (RU) stream, and the high-level waste stream. The features and implications of these three interfaces are reviewed and their implications for P/T system design and for waste management are assessed. The variability of transuranic nuclide composition in the LWR spent fuel is calculated and its potential implications for transmutation system core design are discussed. The radiological characteristics of the RU stream are presented, and options for disposition of the stream are reviewed. Most P/T scenarios assume that RU will be recycled to LWRs. This study demonstrates, however, that LWR recycle cannot totally consume the reprocessed stream, and disposal of a waste uranium steam with high levels of radiologically-significant isotopes will still be necessary. The radioactivity of the tails stream for enrichment plants resulting from a dedicated RU campaign is calculated. The tendency of gaseous diffusion plant enrichment technology to deplete the tails stream of minor uranium isotopes is seen as a benefit and an advantage over Atomic Vapor Laser Isotope Separation-type technology. Finally, the implications of P/T on LWR-origin wastes reporting to the repository is discussed, and several significant differences between LWR-origin waste originating from transmutation systems are assessed

t seddik

Indian Academy of Sciences (India)

Home; Journals; Bulletin of Materials Science. T SEDDIK. Articles written in Bulletin of Materials Science. Volume 40 Issue 6 October 2017 pp 1105-1110. Structural, elastic, optoelectronic and magnetic properties of CdHo 2 S 4 spinel: a first-principle study · I HATRAF O MERABIHA T SEDDIK H BALTACHE R KHENATA R ...

T K Umesh

Indian Academy of Sciences (India)

Home; Journals; Pramana – Journal of Physics. T K Umesh. Articles written in Pramana – Journal of Physics. Volume 58 Issue 1 January 2002 pp 31-38 Research Articles. X-ray fluorescence in some rare earth and high elements excited by 661.6 keV -rays · T Yashoda S Krishnaveni Shivalinge Gowda T K Umesh ...

Pharmacovigilance of artemether-lumefantrine in pregnant women followed until delivery in Rwanda

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Rulisa Stephen

2012-07-01

Full Text Available Abstract Background The World Health Organization presently recommends Artemisinin-based combination therapy (ACT as first-line therapy for uncomplicated P. falciparum malaria. Many malaria-endemic countries, including Rwanda, have adopted these treatment guidelines. The Artemisinin derivative Artemether, in combination with lumefantrine, is currently used in Rwanda for malaria during the second and third trimesters of pregnancy. Safety data on the use of ACT in pregnancy are still limited though and more data are needed. Methods In this pharmacovigilance study, the exposed group (pregnant women with malaria given artemether-lumefantrine, and a matched non-exposed group (pregnant women without malaria and no exposure to artemether-lumefantrine were followed until delivery. Data were collected at public health centres all over Rwanda during acute malaria, routine antenatal visits, after hospital delivery or within 48 hours after home delivery. Information gathered from patients included routine antenatal and peri-partum data, pregnancy outcomes (abortions, stillbirths, at term delivery, congenital malformations and other adverse events through history taking and physical examination of both mothers and newborns. Results The outcomes for the total sample of 2,050 women were for the treatment (n = 1,072 and control groups (n = 978 respectively: abortions: 1.3% and 0.4%; peri-natal mortality 3.7% and 2.8%; stillbirth 2.9% and 2.4%; neonatal death [less than or equal to]7 days after birth 0.5% and 0.4%; premature delivery 0.7% and 0.3%; congenital malformations 0.3% and 0.3%. A total of 129 obstetric adverse events in 127 subjects were reported (7.3% in the treatment group, 5.0% in the control group. In a multivariate regression model, obstetric complications were more frequent in the treatment group (OR (95% CI: 1.38 (0.95, 2.01, and in primigravidae (OR (95% CI 2.65 (1.71, 4.12 and at higher age (OR per year: 1.05 (1.01-1.09. Conclusions

T S Mahesh

Indian Academy of Sciences (India)

Home; Journals; Resonance – Journal of Science Education. T S Mahesh. Articles written in Resonance – Journal of Science Education. Volume 20 Issue 11 November 2015 pp 1053-1065 General Article. Quantum Information Processing by NMR · T S Mahesh · More Details Fulltext PDF ...

Knowledge, Attitude, and Practices regarding Pharmacovigilance and Adverse Drug Reaction reporting among Dental Students in a Teaching Hospital, Jodhpur, India: A Cross-sectional Study.

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Chhabra, Kumar G; Sharma, Ashish; Chhabra, Chaya; Reddy, J Jyothirmai; Deolia, Shravani G; Mittal, Yogesh

2017-10-01

This is a cross-sectional knowledge, attitude, and practices (KAPs) study on pharmacovigilance (PV) and adverse drug reaction (ADR) reporting among dental students in a teaching hospital in India. The aim of this study was to assess the KAP of dental students regarding PV, ADR reporting, and barriers toward the same. A cross-sectional survey using a self-administered, investigator-developed, close-ended questionnaire was conducted in an academic dental hospital in India. All prescribers including third year students, final year students, and house surgeons of the same institute were included for assessment of KAP regarding PV using 16, 8, and 8 items respectively. Data regarding barriers toward ADR reporting and demographics were also collected. Mann-Whitney U-test and Kruskal-Wallis test were applied followed by post hoc test. A total of 241 of 275 respondents participated in the study with a response rate of 87.5%. Overall, 64% reported that they had no idea about the term PV. Age was significantly associated with knowledge (p = 0.045) and attitude (p = 0.016). Barriers contributing to underreporting were difficulty in deciding whether or not an ADR has occurred (52.0%), concerns that the report may be wrong (37%), lack of confidence to discuss ADR with colleagues (29%), and almost no financial benefits (24%). Participants had a comparatively favorable attitude toward PV, but their knowledge and practice need considerable improvements. This study highlights the need for appropriate dental curriculum changes and further multicentric studies to shed more light on important issues of PV among dentists in India. This study explores dentists' knowledge, attitude, and behavior regarding PV, which could help to improve patient's safety and care. The favorable attitude of dentists is an indication that PV could be added in depth in the curriculum and in general practice. Information on barriers for reporting the ADRs could help to find possible solutions for removing the

t v sreenivas

Indian Academy of Sciences (India)

Home; Journals; Sadhana. T V SREENIVAS. Articles written in Sadhana. Volume 41 Issue 11 November 2016 pp 1245-1260. Optimum short-time polynomial regression for signal analysis · A SREENIVASA MURTHY CHANDRA SEKHAR SEELAMANTULA T V SREENIVAS · More Details Abstract Fulltext PDF. We propose ...

Metastatic castration-resistant prostate cancer: time for innovation.

Science.gov (United States)

Tucci, Marcello; Scagliotti, Giorgio Vittorio; Vignani, Francesca

2015-01-01

Androgen deprivation is the mainstay of advanced prostate cancer treatment. Despite initial responses, almost all patients progress to castration-resistant prostate cancer (CRPC). The understanding of the biology of CRPC and the evidence that CRPC still remains driven by androgen receptor signaling led to the discovery of new therapeutic targets. In the last few years, large Phase III trials showed improvements in survival and outcomes and led to the approval of a CYP17 inhibitor (abiraterone), an androgen receptor antagonist (enzalutamide), the taxane cabazitaxel, an α-emitter (radium-223), the bone resorption-targeting drug denosumab and an immunotherapy (sipuleucel-T). This article describes the molecular mechanisms underlying castration resistance, discusses recent and ongoing trials and offers some insights into identifying the best sequence of new drugs.

T R Ramadas

Indian Academy of Sciences (India)

Home; Journals; Resonance – Journal of Science Education. T R Ramadas. Articles written in Resonance – Journal of Science Education. Volume 4 Issue 7 July 1999 pp 79-82 Research News. The Work of the Fields Medallists: 1998 - Maxim Kontsevich · T R Ramadas · More Details Fulltext PDF ...

T S Mohan

Indian Academy of Sciences (India)

Home; Journals; Resonance – Journal of Science Education. T S Mohan. Articles written in Resonance – Journal of Science Education. Volume 1 Issue 5 May 1996 pp 59-67 Feature Article. What's New in Computers The Java Internet Programming Language · T S Mohan · More Details Fulltext PDF ...

Pharmacovigilance from social media: mining adverse drug reaction mentions using sequence labeling with word embedding cluster features.

Science.gov (United States)

Nikfarjam, Azadeh; Sarker, Abeed; O'Connor, Karen; Ginn, Rachel; Gonzalez, Graciela

2015-05-01

Social media is becoming increasingly popular as a platform for sharing personal health-related information. This information can be utilized for public health monitoring tasks, particularly for pharmacovigilance, via the use of natural language processing (NLP) techniques. However, the language in social media is highly informal, and user-expressed medical concepts are often nontechnical, descriptive, and challenging to extract. There has been limited progress in addressing these challenges, and thus far, advanced machine learning-based NLP techniques have been underutilized. Our objective is to design a machine learning-based approach to extract mentions of adverse drug reactions (ADRs) from highly informal text in social media. We introduce ADRMine, a machine learning-based concept extraction system that uses conditional random fields (CRFs). ADRMine utilizes a variety of features, including a novel feature for modeling words' semantic similarities. The similarities are modeled by clustering words based on unsupervised, pretrained word representation vectors (embeddings) generated from unlabeled user posts in social media using a deep learning technique. ADRMine outperforms several strong baseline systems in the ADR extraction task by achieving an F-measure of 0.82. Feature analysis demonstrates that the proposed word cluster features significantly improve extraction performance. It is possible to extract complex medical concepts, with relatively high performance, from informal, user-generated content. Our approach is particularly scalable, suitable for social media mining, as it relies on large volumes of unlabeled data, thus diminishing the need for large, annotated training data sets. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association.

T R Ravindran

Indian Academy of Sciences (India)

Home; Journals; Bulletin of Materials Science. T R Ravindran. Articles written in Bulletin of Materials Science. Volume 36 Issue 7 December 2013 pp 1323-1329. Structural characterization of electrodeposited boron · Ashish Jain C Ghosh T R Ravindran S Anthonysamy R Divakar E Mohandas G S Gupta · More Details ...

T V Ramakrishnan

Indian Academy of Sciences (India)

Home; Journals; Resonance – Journal of Science Education. T V Ramakrishnan. Articles written in Resonance – Journal of Science Education. Volume 22 Issue 8 August 2017 pp 781-785 General Article. Nobel Prize in Physics 2016 · T V Ramakrishnan · More Details Abstract Fulltext PDF. The article describes the ...

Pharmacovigilance in India, Uganda and South Africa with Reference to WHO’s Minimum Requirements

Directory of Open Access Journals (Sweden)

Karen Maigetter

2015-05-01

Full Text Available Background Pharmacovigilance (PV data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. This paper describes the PV systems of India, Uganda and South Africa based on literature and Key Informant (KI interviews and compares them with the World Health Organization’s (WHO’s minimum PV requirements for a Functional National PV System. Methods A documentary analysis of academic literature and policy reports was undertaken to assess the medicines regulatory systems and policies in the three countries. A gap analysis from the document review indicated a need for further research in PV. KI interviews covered topics on PV: structure and practices of the system; current regulatory policy; capacity limitations, staffing, funding and training; availability and reporting of data; and awareness and usage of the systems. Twenty interviews were conducted in India, 8 in Uganda and 11 in South Africa with government officials from the ministries of health, national regulatory authorities, pharmaceutical producers, Non-Governmental Organizations (NGOs, members of professional associations and academia. The findings from the literature and KI interviews were compared with WHO’s minimum requirements. Results All three countries were confronted with similar barriers: lack of sufficient funding, limited number of trained staff, inadequate training programs, unclear roles and poor coordination of activities. Although KI interviews represented viewpoints of the respondents, the findings confirmed the documentary analysis of the literature. Although South Africa has a legal requirement for PV, we found that the three countries uniformly lacked adequate capacity to monitor medicines and evaluate risks according to the minimum standards of the WHO. Conclusion A strong PV system is an important part of the overall medicine regulatory system and reflects on the stringency and competence of the regulatory

T V Venkatesha

Indian Academy of Sciences (India)

Home; Journals; Bulletin of Materials Science. T V Venkatesha. Articles written in Bulletin of Materials Science. Volume 28 Issue 5 August 2005 pp 495-501 Thin Films. A new condensation product for zinc plating from non-cyanide alkaline bath · Y Arthoba Naik T V Venkatesha · More Details Abstract Fulltext PDF.

Utility of social media and crowd-intelligence data for pharmacovigilance: a scoping review.

Science.gov (United States)

Tricco, Andrea C; Zarin, Wasifa; Lillie, Erin; Jeblee, Serena; Warren, Rachel; Khan, Paul A; Robson, Reid; Pham, Ba'; Hirst, Graeme; Straus, Sharon E

2018-06-14

social media conversations for pharmacovigilance is in its infancy. Although social media data has the potential to supplement data from regulatory agency databases; is able to capture less frequently reported AEs; and can identify AEs earlier than official alerts or regulatory changes, the utility and validity of the data source remains under-studied. Open Science Framework ( https://osf.io/kv9hu/ ).

T V Ashwin

Indian Academy of Sciences (India)

Home; Journals; Sadhana. T V Ashwin. Articles written in Sadhana. Volume 27 Issue 1 February 2002 pp 35-58. A font and size-independent OCR system for printed Kannada documents using support vector machines · T V Ashwin P S Sastry · More Details Abstract Fulltext PDF. This paper describes an OCR system for ...

T V Kumari

Indian Academy of Sciences (India)

T V Kumari. Articles written in Bulletin of Materials Science. Volume 25 Issue 2 April 2002 pp 141-154 Biomaterials. Bone growth response with porous hydroxyapatite granules in a critical sized lapine tibial-defect model · Annie John S Abiraman H K Varma T V Kumari P R Umashankar · More Details Abstract Fulltext PDF.

H T Taha

Indian Academy of Sciences (India)

Home; Journals; Sadhana. H T Taha. Articles written in Sadhana. Volume 35 Issue 2 April 2010 pp 177-193. Effects of nanoscale size dependent parameters on lattice thermal conductivity in Si nanowire · M S Omar H T Taha · More Details Abstract Fulltext PDF. The effects of nanoscale size dependent parameters on lattice ...

T P Yadav

Indian Academy of Sciences (India)

Home; Journals; Bulletin of Materials Science. T P Yadav. Articles written in Bulletin of Materials Science. Volume 31 Issue 3 June 2008 pp 313-318. Investigation on carbon nanomaterials: Coaxial CNT-cylinders and CNT-polymer composite · Kalpana Awasthi T P Yadav P R Mishra S Awasthi O N Srivastava · More Details ...

T P Sharma

Indian Academy of Sciences (India)

Home; Journals; Bulletin of Materials Science. T P Sharma. Articles written in Bulletin of Materials Science. Volume 26 Issue 4 June 2003 pp 387-389 Magnetic Materials. Band gap determination of Ni–Zn ferrites · G P Joshi N S Saxena R Mangal A Mishra T P Sharma · More Details Abstract Fulltext PDF. Nanocomposites of ...

T I Eldho

Indian Academy of Sciences (India)

Home; Journals; Sadhana. T I Eldho. Articles written in Sadhana. Volume 31 Issue 6 December 2006 pp 743-754. Hydrodynamic modelling of flow over a spillway using a two-dimensional finite volume-based numerical model · M R Bhajantri T I Eldho P B Deolalikar · More Details Abstract Fulltext PDF. Spillway flow, a ...

Deep learning for pharmacovigilance: recurrent neural network architectures for labeling adverse drug reactions in Twitter posts.

Science.gov (United States)

Cocos, Anne; Fiks, Alexander G; Masino, Aaron J

2017-07-01

Social media is an important pharmacovigilance data source for adverse drug reaction (ADR) identification. Human review of social media data is infeasible due to data quantity, thus natural language processing techniques are necessary. Social media includes informal vocabulary and irregular grammar, which challenge natural language processing methods. Our objective is to develop a scalable, deep-learning approach that exceeds state-of-the-art ADR detection performance in social media. We developed a recurrent neural network (RNN) model that labels words in an input sequence with ADR membership tags. The only input features are word-embedding vectors, which can be formed through task-independent pretraining or during ADR detection training. Our best-performing RNN model used pretrained word embeddings created from a large, non-domain-specific Twitter dataset. It achieved an approximate match F-measure of 0.755 for ADR identification on the dataset, compared to 0.631 for a baseline lexicon system and 0.65 for the state-of-the-art conditional random field model. Feature analysis indicated that semantic information in pretrained word embeddings boosted sensitivity and, combined with contextual awareness captured in the RNN, precision. Our model required no task-specific feature engineering, suggesting generalizability to additional sequence-labeling tasks. Learning curve analysis showed that our model reached optimal performance with fewer training examples than the other models. ADR detection performance in social media is significantly improved by using a contextually aware model and word embeddings formed from large, unlabeled datasets. The approach reduces manual data-labeling requirements and is scalable to large social media datasets. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Fusion blanket testing in MFTF-α + T

International Nuclear Information System (INIS)

Kleefeldt, K.

1985-01-01

The Mirror Fusion Test Facility-α + T (MFTF-α + T) is an upgraded version of the current MFTF-B test facility at Lawrence Livermore National Laboratory, and is designed for near-term fusion-technology-integrated tests at a neutron flux of 2 MW/m 2 . Currently, the fusion community is screening blanket and related issues to determine which ones can be addressed using MFTF-α + T. In this work, the minimum testing needs to address these issues are identified for the liquid-metal-cooled blanket and the solid-breeder blanket. Based on the testing needs and on the MFTF-α + T capability, a test plan is proposed for three options; each option covers a six to seven year testing phase. The options reflect the unresolved question of whether to place the research and development (R and D) emphasis on liquid-metal or solid-breeder blankets. In each case, most of the issues discussed can be addressed to a reasonable extent in MFTF-α+T

Farmacovigilância em tuberculose: relato de uma experiência no Brasil | Pharmacovigilance in tuberculosis: report of an experience in Brazil

Directory of Open Access Journals (Sweden)

Jorge Luiz da Rocha

2015-05-01

Program and the National Health Surveillance Agency (ANVISA developed a partnership to implement a pilot pharmacovigilance project to encourage the reporting of adverse reactions to antitubercular agents. Training followed by monitoring visits was conducted by three reference health services for TB treatment. Among the bottlenecks identified, we found limitations in access to the information system (NOTIVISA, slow Internet connection, poor adverse event reporting in medical records, lack of multidisciplinary integration and involvement of managers, and fragility of information flows. As a consequence, technical instructional materials were developed, the NOTIVISA form was improved and shortened, indicators for monitoring notifications were proposed, and information flows were reset. We conclude that the partnership was successful and suggest a similar strategy for other programs. Integration of health teams as well as development of simplified notification tools are challenges to be overcome if pharmacovigilance actions are to be sustainable in the country.

Long-term safety and efficacy of a pasteurized nanofiltrated prothrombin complex concentrate (Beriplex P/N): a pharmacovigilance study.

Science.gov (United States)

Hanke, A A; Joch, C; Görlinger, K

2013-05-01

The rapid reversal of the effects of vitamin K antagonists is often required in cases of emergency surgery and life-threatening bleeding, or during bleeding associated with high morbidity and mortality such as intracranial haemorrhage. Increasingly, four-factor prothrombin complex concentrates (PCCs) containing high and well-balanced concentrations of vitamin K-dependent coagulation factors are recommended for emergency oral anticoagulation reversal. Both the safety and efficacy of such products are currently in focus, and their administration is now expanding into the critical care setting for the treatment of life-threatening bleeding and coagulopathy resulting either perioperatively or in cases of acute trauma. After 15 yr of clinical use, findings of a pharmacovigilance report (February 1996-March 2012) relating to the four-factor PCC Beriplex P/N (CSL Behring, Marburg, Germany) were analysed and are presented here. Furthermore, a review of the literature with regard to the efficacy and safety of four-factor PCCs was performed. Since receiving marketing authorization (February 21, 1996), ~647 250 standard applications of Beriplex P/N have taken place. During this time, 21 thromboembolic events judged to be possibly related to Beriplex P/N administration have been reported, while no incidences of viral transmission or heparin-induced thrombocytopenia were documented. The low risk of thromboembolic events reported during the observation period (one in ~31 000) is in line with the incidence observed with other four-factor PCCs. In general, four-factor PCCs have proven to be well tolerated and highly effective in the rapid reversal of vitamin K antagonists.

A vaccine strategy with multiple prostatic acid phosphatase-fused cytokines for prostate cancer treatment.

Science.gov (United States)

Fujio, Kei; Watanabe, Masami; Ueki, Hideo; Li, Shun-Ai; Kinoshita, Rie; Ochiai, Kazuhiko; Futami, Junichiro; Watanabe, Toyohiko; Nasu, Yasutomo; Kumon, Hiromi

2015-04-01

Immunotherapy is one of the attractive treatment strategies for advanced prostate cancer. The US Food and Drug Administration (FDA) previously approved the therapeutic vaccine, sipuleucel-T, which is composed of autologous antigen-presenting cells cultured with a fusion protein [prostatic acid phosphatase (PAP) and granulocyte-macrophage colony-stimulating factor (GMCSF)]. Although sipuleucel-T has been shown to prolong the median survival of patients for 4.1 months, more robust therapeutic effects may be expected by modifying the vaccination protocol. In the present study, we aimed to develop and validate a novel vaccination strategy using multiple PAP-fused cytokines for prostate cancer treatment. Using a super gene expression (SGE) system that we previously established to amplify the production of a recombinant protein, significant amounts of PAP-fused cytokines [human GMCSF, interleukin-2 (IL2), IL4, IL7 and mouse GMCSF and IL4] were obtained. We examined the activity of the fusion proteins in vitro to validate their cytokine functions. A significant upregulation of dendritic cell differentiation from monocytes was achieved by PAP-GMCSF when used with the other PAP-fused cytokines. The PAP-fused human IL2 significantly increased the proliferation of lymphocytes, as determined by flow cytometry. We also investigated the in vivo therapeutic effects of multiple PAP-fused cytokines in a mouse prostate cancer model bearing prostate-specific antigen (PSA)- and PAP-expressing tumors. The simultaneous intraperitoneal administration of PAP-GMCSF, -IL2, -IL4 and -IL7 significantly prevented tumor induction and inhibited the tumor growth in the PAP-expressing tumors, yet not in the PSA-expressing tumors. The in vivo therapeutic effects with the multiple PAP-fused cytokines were superior to the effects of PAP-GMCSF alone. We thus demonstrated the advantages of the combined use of multiple PAP-fused cytokines including PAP-GMCSF, and propose a promising prostatic

Key pharmacovigilance stakeholders' experiences of direct patient reporting of adverse drug reactions and their prospects of future development in the European Union.

Science.gov (United States)

Inácio, P; Cavaco, A; Allan, E; Airaksinen, M

2018-02-01

In the European Union (EU), legislation allows patients to directly report adverse drug reactions (ADRs) to competent authorities. Five years after its implementation, patient reporting is not equal in all countries. This study aimed to explore key stakeholders' perceptions of patient reporting in four EU countries. Qualitative study design. Twelve representatives from national pharmacovigilance centres and/or authorities as well as national pharmaceutical industry bodies in four EU countries participated in the study. Supranational organizations were also included. Data collection was via face-semi-structured interviews. Inductive content analysis was performed thereafter, applying principles of risk management as a theoretical framework. Four themes (attitudes and beliefs, system maturation factors, regulatory improvements, and cultural shifts) emerged, conceptually interconnected. Participants from countries introducing patient reporting recently expressed a negative attitude. Participants highlighted the need for additional resources, both human and financial, to address patient reporting and associated advantages. The findings identified perceived barriers and facilitators of patient reporting. The involvement of patients, use of information, and dissemination of patient reporting are far from optimal. A better integration of the work by EU regulatory authorities is recommended. Copyright © 2017 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Patient-reported symptom distress, and most bothersome issues, before and during cancer treatment

Directory of Open Access Journals (Sweden)

Hong F

2016-09-01

Full Text Available Fangxin Hong,1,2 Traci M Blonquist,1 Barbara Halpenny,3 Donna L Berry,3,4 1Department of Biostatistics and Computational Biology, Dana‑Farber Cancer Institute, Boston, MA, USA;2Department of Biostatistics, Harvard School of Public Health, Boston, MA, USA; 3Department of Nursing and Patient Care Services, The Phyllis F. Cantor Center, Dana-Farber Cancer Institute, Boston, MA, USA; 4Department of Medicine, Harvard Medical School, Boston, MA, USA Introduction: Frequently reported symptoms and treatment side effects may not be the most bothersome issues to patients with cancer. The purpose of this study was to investigate patient-reported symptom distress and bothersome issues among participants with cancer. Methods: Participants completed the Symptom Distress Scale-15 before treatment (T1 and during cancer treatment (T2 and reported up to two most bothersome issues among symptoms rated with moderate-to-severe distress. We compared symptom ratings and perceived bother and explored two approaches predicting patients’ most bothersome issues: worst absolute symptom score or worst change from pretreatment. Results: Significantly, (P≤0.0002 more patients reported moderate-to-severe distress at T2 for eight of 13 symptoms. At T1, 81% of patients reported one and 56% reported multiple symptoms with moderate-to-severe distress, while at T2, 89% reported one and 69% reported multiple symptoms with moderate-to-severe distress. Impact on sexual activity/interest, pain, fatigue, and insomnia were the most prevalent symptoms with moderate-to-severe distress. Fatigue, pain, and insomnia were perceived most often as bothersome. When one symptom was rated moderate-to-severe, predictive accuracy of the absolute score was 46% and 48% (T1 & T2 and 38% with the change score (T2–T1. When two or more symptoms were rated moderate-to-severe, predictive accuracy of the absolute score was 76% and 79% (T1 & T2 and 70% with the change score (T2–T1. Conclusion: More

PENGARUH RIGHT ISSUE TERHADAP KINERJA KEUANGAN PERUSAHAAN

Directory of Open Access Journals (Sweden)

Ibnu Khajar

2010-03-01

Full Text Available Penelitian ini menyelidiki pengaruh right issue terhadap kinerja keuangan perusahaan yang go public di Bursa Efek Indonesia. Sampel meliputi dua puluh satu perusahaan yang melakukan right issue dari tahun 2003-2006. Variabel penelitian adalah kinerja keuangan yang diukur dengan rasio likuiditas, leverage, profitabilitas, aktivitas, dan rasio pasar. Paired t-test dan uji Wilcoxon digunakan untuk menentukan perbedaan kinerja keuangan sebelum dan sesudah right issue. Dari rasio kinerja likuiditas, leverage, profitabilitas, aktivitas, dan rasio pasar (Rasio Lancar, Hutang Jumlah Untuk Jumlah Aktiva, Net Profit Margin, Asset Turn Over dan Rasio Price Earning pada dua tahun sebelum dan dua tahun setelah right issue, hanya dua rasio-Harga Earning ratio dan Current Ratio secara signifikan berbeda pada sebelum dan sesudah right issue. Kedua rasio ini meningkat secara signifikan. This study investigated the effect of right issue on the financial performance of companies that go public on the Indonesian Stock Exchange. The sample included twenty-one company that does the right issue from the years 2003-2006. Research variable is financial performance as measured by the liquidity ratio, leverage, profitability, activity, and the ratio of the market. Paired t-test and Wilcoxon test used to determine differences in financial performance before and after the rights issue. From the performance ratios of liquidity, leverage, profitability, activity, and the market ratio (Current Ratio, Total Debt To Total Assets, Net Profit Margin, Asset Turn Over and Price Earning Ratio at two years before and two years after the right issue, only two ratio--Price Earning Ratio and Current Ratio are significantly different at the before and after the rights issue. Both these ratios increased significantly.

T P Nafeesa Baby

Indian Academy of Sciences (India)

Home; Journals; Pramana – Journal of Physics. T P Nafeesa Baby. Articles written in Pramana – Journal of Physics. Volume 80 Issue 2 February 2013 pp 289-294 Research Articles. Plasma excitations in a single-walled carbon nanotube with an external transverse magnetic field · K A Vijayalakshmi T P Nafeesa Baby.

Turning Internet of Things(IoT) into Internet of Vulnerabilities (IoV) : IoT Botnets

OpenAIRE

Angrishi, Kishore

2017-01-01

Internet of Things (IoT) is the next big evolutionary step in the world of internet. The main intention behind the IoT is to enable safer living and risk mitigation on different levels of life. With the advent of IoT botnets, the view towards IoT devices has changed from enabler of enhanced living into Internet of vulnerabilities for cyber criminals. IoT botnets has exposed two different glaring issues, 1) A large number of IoT devices are accessible over public Internet. 2) Security (if cons...

Security and Privacy Issues for an IoT based Smart Home

OpenAIRE

GENEIATAKIS DIMITRIOS; KOUNELIS IOANNIS; NEISSE RICARDO; NAI FOVINO IGOR; STERI GARY; BALDINI GIANMARCO

2017-01-01

Internet of Things (IoT) can support numerous applications and services in various domains, such as smart cities and smart homes. IoT smart objects interact with other components e.g., proxies, mobile devices, and data collectors, for management, data sharing and other activities in the context of the provided service. Though such components contribute to address various societal challenges and provide new advanced services for users, their limited processing capabilities make them vulnerable...

T Kanna

Indian Academy of Sciences (India)

Home; Journals; Pramana – Journal of Physics. T Kanna. Articles written in Pramana – Journal of Physics. Volume 57 Issue 5-6 November-December 2001 pp 885-916 Theoretical aspects of optical solitons. Shape changing collisions of optical solitons, universal logic gates and partially coherent solitons in coupled ...

Ethical Issues in Maternal and Child Health Nursing: Challenges ...

African Journals Online (AJOL)

2016-06-28

Jun 28, 2016 ... and neonatal nurses, face ethical issues possibly because of their ... Aim: To identify the ethical issues related to maternal and child care, the challenges faced by ...... Lucas V.A. The business of women's health care. In: E.T. ...

Farmacovigilância da heparina no Brasil Heparin pharmacovigilance in Brazil

Directory of Open Access Journals (Sweden)

Daniela Rezende Garcia Junqueira

2011-06-01

in Brazil was conducted. RESULTS: Five companies were granted a permission to market unfractioned heparin in Brazil. Three of them are porcine in origin and two of them are bovine in origin, with only one explicitly showing this information in the package insert. The effectiveness and safety of heparin studied in non-Brazilian populations may not represent the Brazilian reality, since most countries no longer produce bovine heparin. The currently marketed heparin has approximately 10% less anticoagulant activity than that previously produced and this change may have clinical implications. CONCLUSIONS: Evidence about the lack of dose interchangeability between bovine and porcine heparins and the unique safety profile of these drugs indicates the need to follow the treatment and the patients' response. Events threatening the patient's safety must be reported to the pharmacovigilance system in each particular country.

T S K V Iyer

Indian Academy of Sciences (India)

Articles written in Resonance – Journal of Science Education. Volume 1 Issue 5 May 1996 pp 29-39 General Article. Chaos Modelling with Computers Unpredicatable Behaviour of Deterministic Systems · Balakrishnan Ramasamy T S K V Iyer · More Details Fulltext PDF. Volume 2 Issue 4 April 1997 pp 76-77 Classroom.

Survey of Security and Privacy Issues of Internet of Things

OpenAIRE

Borgohain, Tuhin; Kumar, Uday; Sanyal, Sugata

2015-01-01

This paper is a general survey of all the security issues existing in the Internet of Things (IoT) along with an analysis of the privacy issues that an end-user may face as a consequence of the spread of IoT. The majority of the survey is focused on the security loopholes arising out of the information exchange technologies used in Internet of Things. No countermeasure to the security drawbacks has been analyzed in the paper.

Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures

Directory of Open Access Journals (Sweden)

Huang Xuan

2012-07-01

Full Text Available Abstract Men with metastatic castration-resistant prostate cancer (mCRPC carry poor prognosis despite the use of docetaxel-based regimens which has modest survival benefit shown by randomized clinical trials. Significant progress in the discovery of novel therapeutic agents has been made in the past few years. While sipuleucel-T, cabazitaxel, and abiraterone gained regulatory approval in 2010 and 2011, several highly promising candidates/regimens have failed in large scale clinical trials. Challenges remain to optimize the design and interpretation of clinical trial results and develop more effective strategies for mCRPC. In this review, we examined the positive and negative clinical trials in mCRPC in the past and discussed the various aspects of clinical trial design including selection of targets and appropriate outcome measures, biomarker development and implementation, and strategies for combination therapy.

Atropinic burden of prescriptions forms in patients with Alzheimer disease: a cross-sectional study in a French PharmacoVigilance Database.

Science.gov (United States)

Montastruc, François; Rouanet, Sarah; Gardette, Virginie; Rousseau, Vanessa; Bagheri, Haleh; Montastruc, Jean-Louis

2015-07-01

Atropinic drugs in patients with Alzheimer disease (AD) can decrease the effects of anticholinesterase drugs and/or induce adverse drug reactions (ADRs). Several atropinic risk scales defining an atropinic burden of drugs were proposed but were little used in AD patients. All ADRs' notifications of AD patients registered in the Midi-Pyrénées PharmacoVigilance Database between 1999 and 2013 were analyzed using Anticholinergic Drug Scale (ADS) and Anticholinergic Duran's list. The primary objective was to quantify atropinic burden in AD patients and the secondary one to investigate associated factors. Among the 475 notifications, at least one atropinic drug was found in 282 notifications (59.4%) according to ADS and 214 (45.1%) according to Duran. Mean number of atropinics per notifications was 0.9 ± 0.9 (ADS) and 0.7 ± 0.9 (Duran). Mean atropinic burden per notifications was 1.2 ± 1.5 (ADS) and 0.9 ± 1.3 (Duran). Atropinic burden ≥ 3 was found in 87 notifications (18.2%) according to ADS and 50 (10.5%) according to Duran. There was no association between atropinic burden and age of patients. The number of drugs is associated to a high atropinic burden. The present work found an association between an atropinic drug and an anticholinesterase agent in around 1 out of 2 AD patients and a clinically significant atropinic burden (≥ 3) in around 1 to 2 AD patients out of 10. The benefit harm balance of atropinic drugs must be discussed before each prescription in AD patients.

Seizures during antidepressant treatment in psychiatric inpatients--results from the transnational pharmacovigilance project "Arzneimittelsicherheit in der Psychiatrie" (AMSP) 1993-2008.

Science.gov (United States)

Köster, M; Grohmann, R; Engel, R R; Nitsche, M A; Rüther, E; Degner, D

2013-11-01

There is little clinical data available about seizure rates in psychiatric inpatients, and there are no studies with reference data to the frequencies of antidepressant (AD) use for this important clinical population. This study investigates seizure rates during AD treatment in psychiatric inpatient settings, drawn from the transnational pharmacovigilance programme Arzneimittelsicherheit in der Psychiatrie (AMSP) in relation to the known frequencies of ADs used in the participating clinics. Comparisons are made to former publications and their limitations. Seventy-seven cases were identified with grand mal seizures (GMS) during AD treatment between 1993 and 2008, with a total number of 142,090 inpatients under surveillance treated with ADs in the participating hospitals. The calculated overall rate of reported seizures of patients during AD treatment in this collective is 0.05 % for ADs imputed alone or in combination with other psychotropic drug groups and 0.02 % when only ADs were given and held responsible for GMS. The patients receiving tri- or tetracyclic ADs (TCAs) had a 2-fold risk to develop a seizure as compared to the overall average rate in this sample. In 11 cases, there was only one AD imputed--the majority of these cases (9/11) were TCA. Monotherapy with selective serotonin reuptake inhibitors (SSRI) or dual serotonin and noradrenaline reuptake inhibitors (SNRI) were never imputed alone in this sample. The results of the study favour the assumption that SSRIs, noradrenergic and specific serotonergic antidepressants (NaSSA) and dual SNRI might be more appropriate than TCAs for the treatment of psychiatric patients with an enhanced seizure risk.

Novel understanding of self-reactive T cells

DEFF Research Database (Denmark)

Andersen, Mads Hald

2016-01-01

In a recent issue of Immunity, Mark Davis and colleagues describe that thymic selection does not eliminate but prunes self-reactive T cell clones. Self-reactive T cells are a natural part of the T-cell repertoire and may be important in the fight against pathogens in addition to being important...

Effective vaccine safety systems in all countries: a challenge for more equitable access to immunization.

Science.gov (United States)

Amarasinghe, Ananda; Black, Steve; Bonhoeffer, Jan; Carvalho, Sandra M Deotti; Dodoo, Alexander; Eskola, Juhani; Larson, Heidi; Shin, Sunheang; Olsson, Sten; Balakrishnan, Madhava Ram; Bellah, Ahmed; Lambach, Philipp; Maure, Christine; Wood, David; Zuber, Patrick; Akanmori, Bartholomew; Bravo, Pamela; Pombo, María; Langar, Houda; Pfeifer, Dina; Guichard, Stéphane; Diorditsa, Sergey; Hossain, Md Shafiqul; Sato, Yoshikuni

2013-04-18

Serious vaccine-associated adverse events are rare. To further minimize their occurrence and to provide adequate care to those affected, careful monitoring of immunization programs and case management is required. Unfounded vaccine safety concerns have the potential of seriously derailing effective immunization activities. To address these issues, vaccine pharmacovigilance systems have been developed in many industrialized countries. As new vaccine products become available to prevent new diseases in various parts of the world, the demand for effective pharmacovigilance systems in low- and middle-income countries (LMIC) is increasing. To help establish such systems in all countries, WHO developed the Global Vaccine Safety Blueprint in 2011. This strategic plan is based on an in-depth analysis of the vaccine safety landscape that involved many stakeholders. This analysis reviewed existing systems and international vaccine safety activities and assessed the financial resources required to operate them. The Blueprint sets three main strategic goals to optimize the safety of vaccines through effective use of pharmacovigilance principles and methods: to ensure minimal vaccine safety capacity in all countries; to provide enhanced capacity for specific circumstances; and to establish a global support network to assist national authorities with capacity building and crisis management. In early 2012, the Global Vaccine Safety Initiative (GVSI) was launched to bring together and explore synergies among on-going vaccine safety activities. The Global Vaccine Action Plan has identified the Blueprint as its vaccine safety strategy. There is an enormous opportunity to raise awareness for vaccine safety in LMIC and to garner support from a large number of stakeholders for the GVSI between now and 2020. Synergies and resource mobilization opportunities presented by the Decade of Vaccines can enhance monitoring and response to vaccine safety issues, thereby leading to more equitable

T N Avinash

Indian Academy of Sciences (India)

Home; Journals; Resonance – Journal of Science Education. T N Avinash. Articles written in Resonance – Journal of Science Education. Volume 7 Issue 2 February 2002 pp 33-45 General Article. Untangling the Mystery of Alzheimer's Disease - Understanding Molecular Mechanisms for Novel Therapeutic Approaches.

T Ishikawa

Indian Academy of Sciences (India)

Home; Journals; Pramana – Journal of Physics. T Ishikawa. Articles written in Pramana – Journal of Physics. Volume 58 Issue 5-6 May-June 2002 pp 761-767 Strongly Correlated Electron Systems. X-ray magnetic circular dichroism at IrL2,3 edges in Fe100-Ir and Co100-Ir alloys: Magnetism of 5d electronic states.

Database Description - tRNADB-CE | LSDB Archive [Life Science Database Archive metadata

Lifescience Database Archive (English)

Full Text Available switchLanguage; BLAST Search Image Search Home About Archive Update History Data List Contact us tRNAD...B-CE Database Description General information of database Database name tRNADB-CE Alter...CC BY-SA Detail Background and funding Name: MEXT Integrated Database Project Reference(s) Article title: tRNAD... 2009 Jan;37(Database issue):D163-8. External Links: Article title: tRNADB-CE 2011: tRNA gene database curat...n Download License Update History of This Database Site Policy | Contact Us Database Description - tRNADB-CE | LSDB Archive ...

Saudi Vigilance Program: Challenges and lessons learned.

Science.gov (United States)

Alharf, Adel; Alqahtani, Nasser; Saeed, Ghazi; Alshahrani, Ali; Alshahrani, Mubarak; Aljasser, Nasser; Alquwaizani, Mohammed; Bawazir, Saleh

2018-03-01

Pharmacovigilance is vital to public health. Adopting a robust spontaneous reporting system for adverse drug events can counteract most hazards that arise from utilizing medicinal products. Prior to the establishment of the Saudi Food and Drug Authority (SFDA), the number of pharmacovigilance-related activities in Saudi Arabia was limited. In 2009, the SFDA established the National Pharmacovigilance and Drug Safety Center (Saudi Vigilance). The pharmacovigilance system has remarkably improved during the past few years. Several initiatives have been taken to improve the program's performance. These initiatives include initiation of pharmacovigilance guidelines, enhancement of communication and reporting tools, training sessions for concerned staff and healthcare providers, and compliance from stakeholders. This review article provides an overview of what the Saudi Vigilance program is, focusing on the scope, mission and vision, hierarchy, operational themes, and overall work processes. Additionally, we will shed light on the challenges we encountered during the early phase and on our future plans.

Sorting Through the Safety Data Haystack: Using Machine Learning to Identify Individual Case Safety Reports in Social-Digital Media.

Science.gov (United States)

Comfort, Shaun; Perera, Sujan; Hudson, Zoe; Dorrell, Darren; Meireis, Shawman; Nagarajan, Meenakshi; Ramakrishnan, Cartic; Fine, Jennifer

2018-06-01

There is increasing interest in social digital media (SDM) as a data source for pharmacovigilance activities; however, SDM is considered a low information content data source for safety data. Given that pharmacovigilance itself operates in a high-noise, lower-validity environment without objective 'gold standards' beyond process definitions, the introduction of large volumes of SDM into the pharmacovigilance workflow has the potential to exacerbate issues with limited manual resources to perform adverse event identification and processing. Recent advances in medical informatics have resulted in methods for developing programs which can assist human experts in the detection of valid individual case safety reports (ICSRs) within SDM. In this study, we developed rule-based and machine learning (ML) models for classifying ICSRs from SDM and compared their performance with that of human pharmacovigilance experts. We used a random sampling from a collection of 311,189 SDM posts that mentioned Roche products and brands in combination with common medical and scientific terms sourced from Twitter, Tumblr, Facebook, and a spectrum of news media blogs to develop and evaluate three iterations of an automated ICSR classifier. The ICSR classifier models consisted of sub-components to annotate the relevant ICSR elements and a component to make the final decision on the validity of the ICSR. Agreement with human pharmacovigilance experts was chosen as the preferred performance metric and was evaluated by calculating the Gwet AC1 statistic (gKappa). The best performing model was tested against the Roche global pharmacovigilance expert using a blind dataset and put through a time test of the full 311,189-post dataset. During this effort, the initial strict rule-based approach to ICSR classification resulted in a model with an accuracy of 65% and a gKappa of 46%. Adding an ML-based adverse event annotator improved the accuracy to 74% and gKappa to 60%. This was further improved by

The Numerology of T Cell Functional Diversity

OpenAIRE

Haining, W. Nicholas

2012-01-01

Memory T cells are heterogeneous in phenotype and function. In this issue of Immunity Newell et al. (2012) use a new flow cytometry platform to show that the functional heterogeneity in the human T cell compartment is even greater than expected.

[Data-mining characteristics of adverse drug reactions and pharmacovi-gilance of Chinese patent drugs including Aconitum herbs].

Science.gov (United States)

Zhang, Xiao-Meng; Li, Fan; Zhang, Bing; Chen, Xiao-Fen; Piao, Jing-Zhu

2018-01-01

The common Aconitum herbs in clinical application mainly include Aconiti Radix(Chuanwu), Aconiti Kusnezoffii Radix(Caowu) and Aconiti Lateralis Radix Praeparaia(Fuzi), all of which have toxicity. Therefore, the safety of using Chinese patent drugs including Aconitum herbs has become an hot topic in clinical controversy. Based on the data-mining methods, this study explored the characteristics and causes of adverse drug reactions/events (ADR/ADE) of the Chinese patent drugs including Aconitum, in order to provide pharmacovigilance and rational drug use suggestions for clinical application. The detailed ADR/ADE reports about the Chinese patent drugs including Aconitum herbs were retrieved in the domestic literature databases since 1984 to now. The information extraction and data-mining were conducted based on the platforms of Microsoft office Excel 2016, Clementine 12.0 and Cytoscape 3.3.0. Finally, 78 detailed ADR/ADE reports involving a total of 30 varieties were included. 92.31% ADR/ADE were surely or likely led by the Chinese patent drugs including Aconitum, mostly involving multiple system/organ damages with good prognosis, and even 1 case of death. The incidence of included ADRs/ADEs was associated with various factors such as the patient idiosyncratic, drug toxicity, as well as clinical medication. The patient age was most closely related to ADR/ADEs, and those aged from 60 to 69 were more easily suffered from the ADRs/ADEs of Chinese patent drugs including Aconitum. The probability of ADR/ADEs for the drugs including Chuanwu or Caowu was greater than that of Fuzi, and the using beyond the instructions dose was the most important potential safety hazard in the clinical medication process. For the regular and characteristics of ADR/ADEs led by Chinese patent drugs including Aconitum, special attention shall be paid to the elder patients or with the patients with allergies; strictly control the dosage and course of treatment, strengthen the safety medication

Environmental issues affecting CCT development

Energy Technology Data Exchange (ETDEWEB)

Wainman, B. [U.S. House of Representatives, Washington, DC (United States)

1997-12-31

The author discusses her thoughts on prospects for an energy policy from this Congress. She doesn`t believe the country will see any big sweeping energy policy acts or even utility deregulation in the next two years. Education on the issues is necessary. The author discusses the impacts for clean coal technologies and recommends continued aggressive work on deployment.

The contribution of pharmacogenetics to pharmacovigilance.

Science.gov (United States)

Bondon-Guitton, Emmanuelle; Despas, Fabien; Becquemont, Laurent

2016-04-01

Since the beginning of this century, information on pharmacogenetics appears in the summary of product characteristics (SPC) of drugs. Pharmacogenetic tests particularly concern the enzymes involved in the metabolism of drugs, among which P450 cytochromes. Some patients known as poor metabolisers eliminate some drugs more slowly, causing overdoses and adverse drug reactions (ADRs). The best-known examples are AVK and VKORC1-CYP2C9 or clopidogrel and CYP2C19. In the USA, the tests are recommended before the introduction of these drugs to prevent the occurrence of ADRs. Other tests are also commonly performed to address the toxicity of certain anticancer drugs (DPYD-capecitabine, UGT1A1-irinotecan, TPMT 6-mercaptopurine). Pharmacogenetic testing is also available to identify HLA loci that are very strongly associated with the occurrence of immuno-allergic reactions to a specific drug. The best-known example is HLA-B*5701, strongly associated with hypersensitivity to abacavir, and this test is now always prescribed before the instatement of this drug. Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

189 Traduction Pharmaceutique: Aperçu Critique D'un Cas ...

African Journals Online (AJOL)

NGOZI

la traduction des documents suivants. • rapports médicaux. • réglementaires, études de toxicité, documents de pharmacovigilance. • notices médicales ... sens émanant du texte qui lui sert d'outil de travail. Pour un traducteur littéraire la tâche est ..... Entreprendre l'inspection des aliments importés, des médicaments, des ...

Adverse reactions to contrast media: an analysis of spontaneous reports in the database of the pharmacovigilance programme of India.

Science.gov (United States)

Kalaiselvan, Vivekanandan; Sharma, Surbhi; Singh, Gyanendra Nath

2014-09-01

Contrast media are used widely to improve medical imaging. Like all other pharmaceuticals, these agents are not completely devoid of risk, and continuous monitoring of adverse reactions with these agents is important. Spontaneous reporting is the simplest method for understanding the safety profile of pharmaceutical products after their approval. Our objective was to identify the pattern and characteristics of adverse reactions attributed to contrast media in the Indian population reported to the National Coordination Centre for the Pharmacovigilance Programme of India (NCC-PvPI). Individual case safety reports (ICSRs) attributed to contrast media submitted spontaneously to the NCC-PvPI were extracted from the database for July 2010 to September 2013. We analysed these reports for information related to reporter's professional category, patient's age and sex, reporter's diagnosis of the reaction, seriousness of the reaction, type of contrast media exposure, system organ class (SOC) affected (as described in World Health Organization Adverse Reaction Terminology [WHO-ART]) and outcome. Of the total 59,915 ICSRs in the database, 415 (0.7%) were suspected adverse reactions to contrast media; 44 reports were serious, including three fatal cases. The most affected SOCs were skin and appendage disorders, body as a whole-general disorders, gastrointestinal system disorders and respiratory system disorders. Hypersensitivity reactions were reported in the majority of ICSRs. The contrast media with the highest number of reports were iohexol (40.7%), iomeprol (17.8%), iopamidol (12%) and diatrizoate (12%). Most of the reactions to contrast media were allergic-like, and no previously unrecognised adverse reactions were observed in the Indian population. Further data and increased awareness among healthcare professionals is required to signal and prevent the consequences of adverse reactions attributed to contrast media.

Memory disorders associated with consumption of drugs: updating through a case/noncase study in the French PharmacoVigilance Database.

Science.gov (United States)

Chavant, Francois; Favrelière, Sylvie; Lafay-Chebassier, Claire; Plazanet, Caroline; Pérault-Pochat, Marie-Christine

2011-12-01

To investigate putative associations of reports of memory disorders and suspected drugs. We used the case/noncase method in the French PharmacoVigilance Database (FPVD). Cases were reports of memory loss in the FPVD between January 2000 and December 2009. Noncases were all other reports during the same period. To assess the association between memory impairment and drug intake, we calculated an odds ratio with its 95% confidence interval. Among the 188,284 adverse drug reactions recorded, we identified 519 cases of memory loss. The sex ratio was 0.6 and the median age was 54 years (range 4-93). The maximal number of cases occurred between 40-49 and 50-59 years. Evolution was favourable in 63% of the cases. We found significant odds ratios for benzodiazepines (alprazolam, bromazepam, prazepam, clonazepam etc.), benzodiazepine-like hypnotics (zolpidem and zopiclone), antidepressants (fluoxetine, paroxetine and venlafaxine), analgesics (morphine, nefopam and tramadol), anticonvulsants (topiramate, pregabalin, levetiracetam etc.), antipsychotics (aripiprazole and lithium) and other drugs, such as trihexyphenidyl, ciclosporin and isotretinoin. Our study confirmed an association between memory disorders and some drugs, such as benzodiazepines and anticonvulsants. However, other drugs, such as benzodiazepine-like hypnotics, newer anticonvulsants, serotonin reuptake inhibitor antidepressants, isotretinoin and ciclosporin were significantly associated with memory disorders, although this was not described or poorly described in the literature. Taking account of the limits of this study in the FPVD (under-reporting, notoriety bias etc.), the case/noncase method allows assessment and detection of associations between exposure to drugs and a specific adverse drug reaction, such as memory disorders, and could thus generate signals and orientate us to further prospective studies to confirm such associations. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011

Seymour Benzer and T4 rII

Indian Academy of Sciences (India)

Home; Journals; Resonance – Journal of Science Education; Volume 13; Issue 10. Seymour Benzer and T4 rII - Running the Map into the Ground. R Jayaraman. General Article Volume 13 Issue 10 October 2008 pp 898-908. Fulltext. Click here to view fulltext PDF. Permanent link:

Internal transport barriers: critical physics issues?

Energy Technology Data Exchange (ETDEWEB)

Litaudon, X [Association Euratom-CEA, DSM, Departement de Recherches sur La Fusion Controlee, Centre d' Etudes de Cadarache, F-13108 Saint-Paul-Lez-Durance (France)

2006-05-15

Plasmas regimes with improved core energy confinement properties, i.e. with internal transport barriers (ITB), provide a possible route towards simultaneous high fusion performance and continuous tokamak reactor operation in a non-inductive current drive state. High core confinement regimes should be made compatible with a dominant fraction of the plasma current self-generated (pressure-driven) by the bootstrap effect while operating at high normalized pressure and moderate current. Furthermore, ITB regimes with 'non-stiff' plasma core pressure break the link observed in standard inductive operation between fusion performances and plasma pressure at the edge, thus offering a new degree of freedom in the tokamak operational space. Prospects and critical issues for using plasmas with enhanced thermal core insulation as a basis for steady tokamak reactor operation are reviewed in the light of the encouraging experimental and modelling results obtained recently (typically in the last two years). An extensive set of data from experiments carried out worldwide has been gathered on ITB regimes covering a wide range of parameters (q-profile, T{sub i}/T{sub e}, gradient length, shaping, normalized toroidal Larmor radius, collisionality, Mach number, etc). In the light of the progress made recently, the following critical physics issues relevant to the extrapolation of ITB regimes to next-step experiments, such as ITER, are addressed: 1. conditions for ITB formation and existence of a power threshold,; 2. ITB sustainment at T{sub i} {approx} T{sub e}, with low toroidal torque injection, low central particle fuelling but at high density and low impurity concentration,; 3. control of confinement for sustaining wide ITBs that encompass a large volume at high {beta}{sub N},; 4. real time profile control (q and pressure) with high bootstrap current and large fraction of alpha-heating and; 5. compatibility of core with edge transport barriers or with external core

Adverse drug reaction and concepts of drug safety in Ayurveda: An overview

Science.gov (United States)

Ajanal, Manjunath; Nayak, Shradda; Prasad, Buduru Sreenivasa; Kadam, Avinash

2013-01-01

Drug safety is a very basic and fundamental concept in medical practice. ADRs play an important role in assessing patient safety in any system of medicine. Pharmacovigilance study is thus significant to understand treatment outcomes. Current raised issue with respect to complementary and alternative system medicine (CAM) like Ayurveda is increased in number of safety reports along with report misinterpretation; this generates the negative impact on system. Although, Ayurveda which is holistic system of medicine from India has elaborated the causes and methods of drug-induced consequences along with preventive measures the available data in classical texts is scattered. The compilation and analysis along with modern concept drug safety is need of the hour. Present literature review was conducted from various compendium of Ayurveda and electronic data base with search terms of ‘Vyapad’, ‘Viruddha’, ‘Ahita’, ‘herb–herb interaction’, ‘idiosyncrasy’, ‘Prakritiviruddha’ etc. The reported information was analysed for the possible correlation on concept of ADR and Pharmacovigilance of current science. Overall review demonstrated that drug interaction, iatrogenic, over dose, administration of unsuitable drugs, reprehensive drug administration with respect to disease, complication from five procedural therapies (Panchakarma) and reprehensible preparation of mineral drug are nearer to the modern causes of ADR. Thus, concept of drug safety and ADR is not new to the Ayurveda. The concept “Drug which is not appropriate to be used as medicine”(Abheshaja) of Ayurveda sounds similar as that of modern pharmacovigilance. PMID:24563588

T V Thanikai Velan

Indian Academy of Sciences (India)

Home; Journals; Bulletin of Materials Science. T V Thanikai Velan. Articles written in Bulletin of Materials Science. Volume 23 Issue 5 October 2000 pp 425-429 Polymers. Aliphatic amine cured PDMS–epoxy interpenetrating network system for high performance engineering applications—Development and characterization.

Сучасні підходи до безперервного аудиту в системі фармаконагляду Вінницької області: підсумки 2016 року

OpenAIRE

Hladkykh, Fedir; Stepaniuk, Heorhii

2017-01-01

The results of the pharmacovigilance system operation in Vinnytsia region during 2016 are presented based on the data of the electronic online system "Pharmacovigilance-2016", which was first introduced by us on the basis of the table editor Microsoft Excel of the file-hosting system Google Drive. The formula for calculating the efficiency of the pharmacovigilance implementation as an integral assessment of the safety oversight of medical devices in their use in Vinnytsia region during 2016 i...

Characterizing Sleep Issues Using Twitter.

Science.gov (United States)

McIver, David J; Hawkins, Jared B; Chunara, Rumi; Chatterjee, Arnaub K; Bhandari, Aman; Fitzgerald, Timothy P; Jain, Sachin H; Brownstein, John S

2015-06-08

Sleep issues such as insomnia affect over 50 million Americans and can lead to serious health problems, including depression and obesity, and can increase risk of injury. Social media platforms such as Twitter offer exciting potential for their use in studying and identifying both diseases and social phenomenon. Our aim was to determine whether social media can be used as a method to conduct research focusing on sleep issues. Twitter posts were collected and curated to determine whether a user exhibited signs of sleep issues based on the presence of several keywords in tweets such as insomnia, "can't sleep", Ambien, and others. Users whose tweets contain any of the keywords were designated as having self-identified sleep issues (sleep group). Users who did not have self-identified sleep issues (non-sleep group) were selected from tweets that did not contain pre-defined words or phrases used as a proxy for sleep issues. User data such as number of tweets, friends, followers, and location were collected, as well as the time and date of tweets. Additionally, the sentiment of each tweet and average sentiment of each user were determined to investigate differences between non-sleep and sleep groups. It was found that sleep group users were significantly less active on Twitter (P=.04), had fewer friends (Pcost-effective, and customizable data to be gathered.

Clinical roundtable monograph: new and emerging treatments for advanced prostate cancer.

Science.gov (United States)

George, Daniel J; Kantoff, Philip W; Lin, Daniel W

2011-06-01

Historically, the treatment of metastatic castration-resistant prostate cancer (CRPC) has been limited to chemotherapeutic regimens that did not improve patient survival. In 2004, clinical studies began to demonstrate significant improvements in patient outcomes, including overall survival, with docetaxel versus mitoxantrone chemotherapy. Since these pivotal trials, the combination of docetaxel plus prednisone has become a standard of care for patients with metastatic CRPC. However, the limited survival benefit achieved with this regimen prompted several investigations into the development of alternative therapeutic options. Recent advances have now led to an unprecedented number of new drug approvals within the past year, providing many new treatment options for patients with metastatic CRPC. Sipuleucel-T, considered a new paradigm in cancer treatment, is the first such immunotherapeutic agent approved by the US Food and Drug Administration. Other successes include abiraterone acetate, the first androgen biosynthesis inhibitor, and cabazitaxel, a novel microtubule inhibitor, both of which have demonstrated improved survival following docetaxel failure. The bone-targeting agent denosumab, also recently approved in this setting, offers these patients significant improvement in the prevention of skeletal-related events. The data supporting the approval of each of these agents are described in this monograph, as are current approaches in the treatment of metastatic CRPC and ongoing clinical trials of novel treatments and strategies. The experts also discuss several of the issues regarding the introduction of these novel agents into clinical practice for metastatic CRPC patients.

Kadın Kütüphaneciler: Toplumsal Cinsiyet Sorunları = Female Librarians: Gender Issues

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Murat Yılmaz

2013-06-01

Full Text Available Bu araştırmanın amacı, kadın kütüphanecilerin cinsiyet ayrımcılığından dolayı kütüphanelerde karşılaşacakları olası sorunları irdelemektir. Bu amaç doğrultusunda araştırmada, kadın kütüphanecilerin kütüphanelerde karşılaşacakları sorunlar şu şekilde ayrılmıştır; ○ kütüphanelerde cinsel istismar (mobbing; ○ ücret ayrımcılığı (kadın kütüphaneci olarak düşük ücret alma ○ kariyer gelişiminde cinsiyet ayrımcılığı; ○ kadın kütüphaneci olarak haksız yere işten çıkarılma ○ kadın kütüphaneci olarak kariyere ara verme (evlilik ya da bebek sahibi olma gibi nedenler ve ○ iş görüşmelerinde kişisel sorularla karşılaşma (evlilikle ya da annelikle ilgili zamanlamayla ilgili sorular. Ayrıca araştırmada, kadın kütüphanecilerin cinsiyet ayrımcılığına ilişkin kütüphanelerde karşılaşacakları yukarıda sıralanan sorunlara ilişkin çeşitli çözüm önerileri de tartışılmıştır./The purpose of this study is to examine the possible problems being met by female librarians due to gender discrimination in libraries. With this purpose in this study, the relevant problems being met by female librarians in libraries are divided as follows; sexual harassment (mobbing in libraries, wage discrimination (receiving a low wage as a female librarian, gender discrimination in career development, unfair dismissal as a female librarian, career break as a female librarian (because of marriage or having a new baby, and encountering the personal questions in job interviews (such as the questions of the timing of marriage or motherhood. Furthermore, in the study, various recommendations for solving the above problems of gender discrimination met by female librarians in libraries have been also discussed.

Applying the CobiT Control Framework to Spreadsheet Developments

OpenAIRE

Butler, Raymond J.

2008-01-01

One of the problems reported by researchers and auditors in the field of spreadsheet risks is that of getting and keeping managements attention to the problem. Since 1996, the Information Systems Audit & Control Foundation and the IT Governance Institute have published CobiT which brings mainstream IT control issues into the corporate governance arena. This paper illustrates how spreadsheet risk and control issues can be mapped onto the CobiT framework and thus brought to managers attention i...

City Hub : a cloud based IoT platform for Smart Cities

OpenAIRE

Lea, Rodger; Blackstock, Michael

2014-01-01

Cloud based Smart City hubs are an attractive approach to addressing some of the complex issues faced when deploying PaaS infrastructure for Smart Cities. In this paper we introduce the general notion of IoT hubs and then discusses our work to generalize our IoT hub as a Smart City PaaS. Two key issues are identified, support for hybrid public/private cloud and interoperability. We briefly describe our approach to these issues and discuss our experiences deploying two cloud-based Smart City h...

Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US.

Science.gov (United States)

Bahk, Chi Y; Goshgarian, Melanie; Donahue, Krystal; Freifeld, Clark C; Menone, Christopher M; Pierce, Carrie E; Rodriguez, Harold; Brownstein, John S; Furberg, Robert; Dasgupta, Nabarun

salpingectomy (62), were reported by 598 women (44.3 %). Other events of interest included loss of libido ( n  = 115); allergy to metals (109), primarily nickel; and alopecia (252). VigiGrade completeness scores were high, averaging 0.80 (±0.15). Reports received via the mobile app were considered "well documented" 55.9 % of the time, compared with an international average of 13 % for all medical products. On average, there were 15 times more reports submitted per month via the app with patient community support versus traditional pharmacovigilance portals. Outreach via an online patient community, coupled with an easy-to-use app, allowed for rapid and detailed ICSRs to be submitted, with gains in efficiency. Two-way communication and public posting of narratives led to successful engagement within a Motivation-Incentive-Activation-Behavior framework, a conceptual model for successful crowdsourcing. Reports submitted by patients were considerably more complete than those submitted by physicians in routine spontaneous reports. Further research is needed to understand how biases operate differently from those of traditional pharmacovigilance.

Healthcare professionals and pharmacovigilance of pediatric adverse drug reactions: a 5-year analysis of Adverse Events Reporting System database of the Food and Drug Administration.

Science.gov (United States)

Bigi, Caterina; Tuccori, Marco; Bocci, Guido

2017-02-17

To analyze the Adverse Events Reporting System (AERS) database of the Food and Drug Administration (FDA), investigating the characteristics of pediatric adverse drug reactions (ADRs) and describing the effective participation of healthcare professionals in the reporting activity. Reports of ADRs were obtained from the FDA website. Only ADRs in pediatric subjects (divided by age, by country and by professional category) were included into the analysis. The drugs suspected as primary cause of the ADRs in pediatric subjects and their principal anatomic group according to the Anatomical Therapeutic Chemical classification system were considered. To classify the ADRs, the Medical Dictionary for Regularity Activities terminology was adopted. Between 2008 and 2012, FDA collected 113,077 ADRs in pediatric patients. Of the total pediatric ADR reports, those performed by medical doctors were 32%, followed by consumers (26%) and healthcare professionals (25%). Most of the ADR reports were related to the adolescent group (39%). Healthcare professionals resulted the category with the highest rate of ADR reports in neonates and infants. Drugs acting on nervous system and antineoplastic/immunomodulating agents were the most involved the pediatric ADR reports. Pyrexia, convulsion, vomiting and accidental overdose were the reactions more reported both from healthcare professionals and medical doctors. The present study describes the pediatric ADR reports of the FDA database through healthcare professional's perspective, describing the various aspects of pediatric pharmacovigilance.

The numerology of T cell functional diversity.

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Haining, W Nicholas

2012-01-27

Memory T cells are heterogeneous in phenotype and function. In this issue of Immunity, Newell et al. (2012) use a new flow cytometry platform to show that the functional heterogeneity of the human T cell compartment is even greater than previously thought. Copyright © 2012 Elsevier Inc. All rights reserved.

The rise of repeal: policy entrepreneurship and Don't Ask, Don't Tell.

Science.gov (United States)

Neff, Christopher L; Edgell, Luke R

2013-01-01

We report on policy entrepreneurship by Servicemembers Legal Defense Network (SLDN) and how its legislative strategies used mini-windows of opportunity to shift Capitol Hill perspectives of Don't Ask, Don't Tell (DADT) from political plutonium to an emerging issue requiring a second look. Four phases in the legislative history of DADT are identified: radioactive, contested, emerging, and viable. In all, this article argues that SLDN's entrepreneurship focused on contesting congressional sensibilities to wait or defer on repeal, maintained that every discharge was damaging and transitioned toward a post-repeal mind set. Finally, we illustrate the importance of these transitions by comparing SLDN's 2004 estimated vote count for the introduction of the Military Readiness Enhancement Act with the final 2010 voting results on the Don't Ask, Don't Tell Repeal Act.

felix t s chan

Indian Academy of Sciences (India)

Home; Journals; Sadhana. FELIX T S CHAN. Articles written in Sadhana. Volume 42 Issue 3 March 2017 pp 391-403. A hybrid multi-objective evolutionary algorithm approach for handling sequence- and machine-dependent set-up times in unrelated parallel machine scheduling problem · V K MANUPATI G ...

A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER Database and Association Analysis.

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Masakazu Fujiwara

Full Text Available Rapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender has not been proposed.We utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA. We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male.Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported adverse drug reactions

Persistent Sexual Dysfunction and Suicidal Ideation in Young Men Treated with Low-Dose Finasteride: A Pharmacovigilance Study.

Science.gov (United States)

Ali, Ayad K; Heran, Balraj S; Etminan, Mahyar

2015-07-01

Finasteride, a 5α-reductase inhibitor, is marketed in a low dose (1 mg) as a popular therapy for androgenic alopecia in young men. As case reports and small surveys have suggested a link between persistent sexual dysfunction (SD) and suicidal ideation (SI) with low-dose finasteride, the aim of this study was to detect signals of SD and SI secondary to low-dose finasteride use in young men. Retrospective pharmacovigilance disproportionality analysis. United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. Low-dose finasteride-related adverse event reports for men aged 18-45 years that were submitted to the FAERS between 1998 and 2013 were retrieved. Multi-item Gamma Poisson Shrinker disproportionality analysis was applied to calculate the empirical Bayes geometric mean (EBGM) and corresponding 95% confidence interval (CI) as an association metric between low-dose finasteride and the events of interest. Signals were defined as associations with thresholds of a CI lower limit of 2.0 or greater. Medical Dictionary for Regulatory Activities Preferred Terms denoting to SD and SI were identified to reflect the outcome of interest. In total, of 4910 reports, 577 persistent SD and 39 SI adverse event reports (11.8% and 7.9%, respectively) were identified for young men using low-dose finasteride; 34 (87.2%) of the 39 men with SI also experienced SD. The majority of these events were serious (e.g., contributed to the patient's death, hospitalization, or disability). Low-dose finasteride was associated with more than expected reporting of SD in young men compared with reporting of these events with all other drugs within the database (EBGM 28.0, 95% CI 26.1-30.0). Disproportional reporting in SI events was noted, although it did not reach signal threshold (EBGM 1.72; 95% CI 1.31-2.23). Among serious SD events, 43% led to disability; 28% required medical intervention, including hospitalization; and 5% were life-threatening. Six fatal SD

Role of Tertiary Lymphoid Structures (TLS) in Anti-Tumor Immunity: Potential Tumor-Induced Cytokines/Chemokines that Regulate TLS Formation in Epithelial-Derived Cancers

Energy Technology Data Exchange (ETDEWEB)

Pimenta, Erica M. [Rutgers Biomedical and Health Sciences, New Jersey Medical School-Cancer Center, Newark, NJ 07103 (United States); Barnes, Betsy J., E-mail: barnesbe@njms.rutgers.edu [Department of Biochemistry and Molecular Biology, Rutgers Biomedical and Health Sciences, New Jersey Medical School-Cancer Center, Newark, NJ 07103 (United States)

2014-04-23

Following the successes of monoclonal antibody immunotherapies (trastuzumab (Herceptin{sup ®}) and rituximab (Rituxan{sup ®})) and the first approved cancer vaccine, Provenge{sup ®} (sipuleucel-T), investigations into the immune system and how it can be modified by a tumor has become an exciting and promising new field of cancer research. Dozens of clinical trials for new antibodies, cancer and adjuvant vaccines, and autologous T and dendritic cell transfers are ongoing in hopes of identifying ways to re-awaken the immune system and force an anti-tumor response. To date, however, few consistent, reproducible, or clinically-relevant effects have been shown using vaccine or autologous cell transfers due in part to the fact that the immunosuppressive mechanisms of the tumor have not been overcome. Much of the research focus has been on re-activating or priming cytotoxic T cells to recognize tumor, in some cases completely disregarding the potential roles that B cells play in immune surveillance or how a solid tumor should be treated to maximize immunogenicity. Here, we will summarize what is currently known about the induction or evasion of humoral immunity via tumor-induced cytokine/chemokine expression and how formation of tertiary lymphoid structures (TLS) within the tumor microenvironment may be used to enhance immunotherapy response.

Role of Tertiary Lymphoid Structures (TLS in Anti-Tumor Immunity: Potential Tumor-Induced Cytokines/Chemokines that Regulate TLS Formation in Epithelial-Derived Cancers

Directory of Open Access Journals (Sweden)

Erica M. Pimenta

2014-04-01

Full Text Available Following the successes of monoclonal antibody immunotherapies (trastuzumab (Herceptin® and rituximab (Rituxan® and the first approved cancer vaccine, Provenge® (sipuleucel-T, investigations into the immune system and how it can be modified by a tumor has become an exciting and promising new field of cancer research. Dozens of clinical trials for new antibodies, cancer and adjuvant vaccines, and autologous T and dendritic cell transfers are ongoing in hopes of identifying ways to re-awaken the immune system and force an anti-tumor response. To date, however, few consistent, reproducible, or clinically-relevant effects have been shown using vaccine or autologous cell transfers due in part to the fact that the immunosuppressive mechanisms of the tumor have not been overcome. Much of the research focus has been on re-activating or priming cytotoxic T cells to recognize tumor, in some cases completely disregarding the potential roles that B cells play in immune surveillance or how a solid tumor should be treated to maximize immunogenicity. Here, we will summarize what is currently known about the induction or evasion of humoral immunity via tumor-induced cytokine/chemokine expression and how formation of tertiary lymphoid structures (TLS within the tumor microenvironment may be used to enhance immunotherapy response.

A Step Towards Checking Security in IoT

Directory of Open Access Journals (Sweden)

Chiara Bodei

2016-08-01

Full Text Available The Internet of Things (IoT is smartifying our everyday life. Our starting point is IoT-LySa, a calculus for describing IoT systems, and its static analysis, which will be presented at Coordination 2016. We extend the mentioned proposal in order to begin an investigation about security issues, in particular for the static verification of secrecy and some other security properties.

A Step Towards Checking Security in IoT

OpenAIRE

Bodei, Chiara; Degano, Pierpaolo; Ferrari, Gian-Luigi; Galletta, Letterio

2016-01-01

The Internet of Things (IoT) is smartifying our everyday life. Our starting point is IoT-LySa, a calculus for describing IoT systems, and its static analysis, which will be presented at Coordination 2016. We extend the mentioned proposal in order to begin an investigation about security issues, in particular for the static verification of secrecy and some other security properties.

Text mining for adverse drug events: the promise, challenges, and state of the art.

Science.gov (United States)

Harpaz, Rave; Callahan, Alison; Tamang, Suzanne; Low, Yen; Odgers, David; Finlayson, Sam; Jung, Kenneth; LePendu, Paea; Shah, Nigam H

2014-10-01

Text mining is the computational process of extracting meaningful information from large amounts of unstructured text. It is emerging as a tool to leverage underutilized data sources that can improve pharmacovigilance, including the objective of adverse drug event (ADE) detection and assessment. This article provides an overview of recent advances in pharmacovigilance driven by the application of text mining, and discusses several data sources-such as biomedical literature, clinical narratives, product labeling, social media, and Web search logs-that are amenable to text mining for pharmacovigilance. Given the state of the art, it appears text mining can be applied to extract useful ADE-related information from multiple textual sources. Nonetheless, further research is required to address remaining technical challenges associated with the text mining methodologies, and to conclusively determine the relative contribution of each textual source to improving pharmacovigilance.

The need for greater opioid pharmacovigilance in COPD

Directory of Open Access Journals (Sweden)

Vozoris NT

2017-01-01

Full Text Available Nicholas T Vozoris1–3 1Division of Respirology, Department of Medicine, St Michael’s Hospital, Toronto, ON, Canada; 2Keenan Research Centre in the Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, ON, Canada; 3Department of Medicine, University of Toronto, Toronto, ON, Canada I read with interest the article by Ahmadi et al1 that described the use of prescription opioid drugs among Swedes with advanced COPD. The authors are to be commended for their research work on this important clinical topic. I would like to bring to the attention of your readers several points though. Read the original article by Ahmadi et al

Proposals For The Secure Use Of IoT Technology In The Car Industry - Proposals on how to use IoT technology in the car industry but avoid its negative security consequences

OpenAIRE

Ramquist, Robin

2016-01-01

The Internet Of Things (IoT) is a hotter topic than ever. As devices and our daily life get connected to the IoT, we also put ourselves at risk. IoT security issues get reported on a regular basis, and experts are concerned that we will lose control of the situation. In this thesis, the IoT usage in the car industry is investigated and analyzed, and proposals for security issue mitigations are presented based on existing research. To do this work, existing research is being looked at and inte...

Immunotherapy: Shifting the Balance of Cell-Mediated Immunity and Suppression in Human Prostate Cancer

Energy Technology Data Exchange (ETDEWEB)

Tucker, Jo A.; Jochems, Caroline [Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892 (United States); Gulley, James L. [Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892 (United States); Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892 (United States); Schlom, Jeffrey, E-mail: js141c@nih.gov; Tsang, Kwong Y. [Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892 (United States)

2012-12-11

Active immunotherapy is dependent on the ability of the immune system to recognize and respond to tumors. Despite overwhelming evidence to support a cell-mediated immune response to prostate cancer, it is insufficient to eradicate the disease. This is likely due to a high level of suppression at the tumor site from a variety of sources, including immunosuppressive cells. Immune cells entering the tumor microenvironment may be inhibited directly by the tumor, stromal cells or other immune cells that have been induced to adopt a suppressive phenotype. The resurgence of interest in immunotherapy following the approval of sipuleucel-T and ipilimumab by the Food and Drug Administration has brought about new strategies for overcoming tumor-mediated suppression and bolstering anti-tumor responses. Improved understanding of the immune response to prostate cancer can lead to new combination therapies, such as the use of vaccine with small molecule and checkpoint inhibitors or other immunotherapies.

Immunotherapy: Shifting the Balance of Cell-Mediated Immunity and Suppression in Human Prostate Cancer

International Nuclear Information System (INIS)

Tucker, Jo A.; Jochems, Caroline; Gulley, James L.; Schlom, Jeffrey; Tsang, Kwong Y.

2012-01-01

Active immunotherapy is dependent on the ability of the immune system to recognize and respond to tumors. Despite overwhelming evidence to support a cell-mediated immune response to prostate cancer, it is insufficient to eradicate the disease. This is likely due to a high level of suppression at the tumor site from a variety of sources, including immunosuppressive cells. Immune cells entering the tumor microenvironment may be inhibited directly by the tumor, stromal cells or other immune cells that have been induced to adopt a suppressive phenotype. The resurgence of interest in immunotherapy following the approval of sipuleucel-T and ipilimumab by the Food and Drug Administration has brought about new strategies for overcoming tumor-mediated suppression and bolstering anti-tumor responses. Improved understanding of the immune response to prostate cancer can lead to new combination therapies, such as the use of vaccine with small molecule and checkpoint inhibitors or other immunotherapies

Challenges in the sequencing of therapies for the management of metastatic castration-resistant prostate cancer.

Science.gov (United States)

Parente, Phillip; Parnis, Francis; Gurney, Howard

2014-09-01

Prior to 2010, docetaxel was the standard option for chemotherapy in men with metastatic castration-resistant prostate cancer (mCRPC). Today, the picture is vastly different: several additional therapies have each demonstrated a survival benefit such that we now have chemotherapy (cabazitaxel), androgen suppressive agents (abiraterone acetate and enzalutamide), a cellular vaccine (sipuleucel-T) and radium-233 (for symptomatic bone metastases). With several other agents in the pipeline for late-stage disease, the future looks promising for mCRPC. As the available data are not able to inform as to the optimum sequencing of therapy, this remains a challenge. This paper draws on insights from published and ongoing clinical studies to provide a practical patient-focused approach to maximize the benefits of the current therapeutic armamentarium. Preliminary sequencing suggestions are made based on clinical trial criteria. But until more data become available, clinical gestalt, experience, cost and individual patient preferences will continue to drive choices. © 2014 Wiley Publishing Asia Pty Ltd.

The Impact of Experiencing Adverse Drug Reactions on the Patient's Quality of Life : A Retrospective Cross-Sectional Study in the Netherlands

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Rolfes, Leàn; van Hunsel, Florence; Taxis, Katja; van Puijenbroek, Eugène

INTRODUCTION: There is little information as to what extent adverse drug reactions (ADRs) influence patients' health-related quality of life (HR-QOL). From a pharmacovigilance perspective, capturing and making the best use of this information remains a challenge. The Netherlands Pharmacovigilance

Combination L-T3 and L-T4 therapy for hypothyroidism.

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Wartofsky, Leonard

2013-10-01

Because of the longstanding controversy regarding whether hypothyroid patients can be optimally replaced by treatment with levothyroxine (L-T4) alone, numerous studies have addressed potential benefits of combined therapy of triiodothyronine (T3) with L-T4. Results of these studies have failed to support a potential benefit of combined therapy. A strong argument for the addition of L-T3 to L-T4 monotherapy has been lacking until recent genetic studies indicated a rationale for such therapy among a small fraction of the hypothyroid patient population. Interest in this issue has focused on the importance of the deiodinases in maintaining the euthyroid state and the role of genetic polymorphisms in the deiodinase genes that would affect thyroid hormone concentrations in both blood and tissues. One such polymorphism in the D2 gene, Thr92Ala, is associated with reduced T4 to T3 activation in skeletal muscle and thyroid, linked to obesity and alterations in thyroid-pituitary feedback, and in responses to thyroid hormone treatment. Although our professional organizations continue to recommend L-T4 alone for the treatment of hypothyroidism, the possibility of a D2 gene polymorphism should be considered in patients on L-T4 monotherapy who continue to complain of fatigue in spite of dosage achieving low normal serum thyroid stimulating hormone levels. A suggestive clue to the presence of this polymorphism could be a higher than normal free T4/free T3 ratio. Clinicians could consider adding T3 as a therapeutic trial in selected patients. Future well controlled clinical trials will be required to more fully resolve the controversy.

Evaluation of a campaign to improve awareness and attitudes of young people towards mental health issues.

Science.gov (United States)

Livingston, James D; Tugwell, Andrew; Korf-Uzan, Kimberly; Cianfrone, Michelle; Coniglio, Connie

2013-06-01

This study evaluated the effectiveness of the In One Voice campaign for raising mental health awareness and improving attitudes of youth and young adults towards mental health issues. The campaign featured a prominent male sports figure talking about mental health issues and used online social media. A successive independent samples design assessed market penetration and attitudinal changes among the young people. Two samples completed an online questionnaire either immediately before (T1: n = 403) or 2 months after (T2: n = 403) the campaign launch. Website analytics determined changes in activity levels of a youth-focused mental health website (mindcheck.ca). One-quarter (24.8 %, n = 100) of the respondents remembered the campaign. The proportion of respondents who were aware of the website increased significantly from 6.0 % at T1 to 15.6 % at T2. Average overall scores on standardized measures of personal stigma and social distance were not significantly different between T1 and T2 respondents. Attitudes towards mental health issues were statistically similar between respondents who were or were not exposed to the campaign. Those who were exposed to the campaign were significantly more likely to talk about and seek information relating to mental health issues. The proximal outcomes of the campaign to increase awareness and use of the website were achieved. The distal outcome of the campaign to improve attitudes towards mental health issues was not successfully achieved. The brief social media campaign improved mental health literacy outcomes, but had limited effect on personal stigma and social distance.

Die vrou in T.T. Cloete se 'toepasslngs van dante'

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R. Ward

1998-04-01

Full Text Available Woman in T.T. Cloete’s 'toepasslngs van dante' In T.T. Cloete's fourth collection of poems, Idiolek (1986, several references are made to the poetry of Dante Alighieri. At the core of this collection are three poems under the heading "toepassings van dante". The first, "Silhoeët van Beatrice", is a description of the outline of Beatrice's naked body. The second poem, "mooi marilyn monroe foto in rooi", is based on a pin-up of Marilyn Monroe posing naked against a backdrop of red velvet. Although these two women are almost exact opposites - Beatrice possessing a divine beauty and an almost Christ-like nature, whereas Marilyn Monroe is portrayed as a dumb blonde and sex symbol of the fifties - the two poems are suspiciously similar in style and content. Both women are portrayed as being fundamentally perfect ("fundamenteel perfek". In symbolizing the same virtues, they lose their unique and contrasting characteristics, and merge into a symbol of female perfection. Although the third poem, "columbae", does not have the Beatrice/Marilyn Monroe-figure as subject matter, it can be read as dealing with the issue of individuality and uniqueness, thus commenting on the previous two poems.

78 FR 55103 - Notice of Proposed Exemption involving AT&T Inc. (Together With AT&T Inc.'s Affiliates, AT&T or...

Science.gov (United States)

2013-09-09

... the issues to be addressed and include a general description of the evidence to be presented at the... January 1, 2018 0.0 January 1, 2019 0.0 Total 2.975 The Applicant represents that these minimum required... unilateral right to trigger the Put Option. Settlement. At the sole election of AT&T, Inc., or any other...

Special journal issue focuses on urban violence, poverty, and ...

International Development Research Centre (IDRC) Digital Library (Canada)

2015-10-02

Oct 2, 2015 ... In a special issue of the journal, Mouvements et enjeux sociaux [Social ... what works and what doesn't — to reduce violence in urban centres. ... to prevent crime, including mental health support, building community trust.

Recent and future situation of Japan’s T&D system

Directory of Open Access Journals (Sweden)

Kyoichi Uehara

2016-01-01

Full Text Available Japan suffered from the Great East Japan Earthquake followed by the nuclear disaster. As a result, we experienced rolling outages for a few months in the Tokyo and Tohoku area. Japan’s power transmission system consists of 50 Hz AC and 60 Hz AC in eastern and western Japan respectively. When the nuclear disaster occurred in Fukushima, enough electricity hasn’t been supplied in eastern area. Power interchange capacity between east and west was small because of small redundant T&D system design. Based on this rolling outage and some present electricity supplying issues in Japan, METI (Ministry of Economy, Trade and Industry has set the electricity system reform committee to improve this situation and make a good T&D system for the future. This committee reported the discussed issue to the Japanese METI and METI proposed policy on Electricity System Reform to the Japanese Cabinet. As a result, the Japanese Electricity System Reform policy was adopted. This future T&D system deals with redundant T&D systems between east and west, how to handle large amounts of renewable electrical energy, and how to fully de-regulate the distribution market. HVDC (VSC system will be introduced between Hokkaido and Honshu as a subsea cable transmission system and HVDC transmission system between eastern area and western area. This paper describes recent and future Japan’s T&D systems. This will be helpful to understand how to solve the issues of Japan’s T&D system.

Design and methods for a Scandinavian pharmacovigilance study of osteonecrosis of the jaw and serious infections among cancer patients treated with antiresorptive agents for the prevention of skeletal-related events

Directory of Open Access Journals (Sweden)

Acquavella J

2016-07-01

Full Text Available John Acquavella,1 Vera Ehrenstein,1 Morten Schiødt,2 Uffe Heide-Jørgensen,1 Anders Kjellman,3,4 Svein Hansen,5 Cecilia Larsson Wexell,6,7 Bente Brokstad Herlofson,8 Sven Erik Noerholt,9 Haijun Ma,10 Katarina Öhrling,11 Rohini K Hernandez,12 Henrik Toft Sørensen1 1Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Department of Oral and Maxillofacial Surgery, Rigshospitalet, Copenhagen, Denmark; 3Department of Urology, Karolinska University Hospital, 4Department of Clinical Science, Intervention, and Technology, Karolinska Institutet, Stockholm, Sweden; 5Cancer Registry of Norway, Oslo University Hospital, Oslo, Norway; 6Department of Oral and Maxillofacial Surgery, Södra Älvsborg Hospital, Borås, Sweden; 7Department of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; 8Department of Oral Surgery and Oral Medicine, Faculty of Dentistry, University of Oslo, Oslo, Norway; 9Department of Oral and Maxillofacial Surgery, Aarhus University Hospital, Aarhus, Denmark; 10Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA; 11Clinical Development, Amgen Inc., Thousand Oaks, CA, USA; 12Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA Objective: Osteonecrosis of the jaw (ONJ is a recognized complication of potent antiresorptive therapies, especially at the doses indicated to prevent skeletal complications for cancer patients with bone metastases. This paper describes the rationale and methods for a prospective, post-authorization safety study of cancer patients treated with antiresorptive therapies. Methods: As part of a comprehensive pharmacovigilance plan, developed with regulators’ input, the study will estimate incidence of ONJ and of serious infections among adult cancer patients with bone metastases treated with denosumab (120 mg subcutaneously or zoledronic acid (4 mg intravenously, adjusted for renal function

Hijacking T cell differentiation: new insights in TLX function in T-ALL.

Science.gov (United States)

King, Bryan; Ntziachristos, Panagiotis; Aifantis, Iannis

2012-04-17

TLX1 and TLX3 are two closely-related homeobox transcriptional repressors frequently misexpressed and translocated in T cell acute lymphoblastic leukemia (T-ALL). In this issue of Cancer Cell, Dadi et al. provide new insights into how these factors are recruited by ETS-1 to the TCRα enhancer and actively repress differentiation. Copyright © 2012 Elsevier Inc. All rights reserved.

Information Security Issues in a Digital Library Environment: A Literature Review = Dijital Kütüphane Ortamında Bilgi Güvenliği Sorunları: Literatür Değerlendirmesi

Directory of Open Access Journals (Sweden)

Anday, Audrey

2012-01-01

Full Text Available This paper aimed to explore the literature on security issues that digital libraries should consider in managing digital resources. Books on information security and network security were consulted as well as several databases such as ERIC, Ebrary, LISA, Science Direct, EbscoHost, ISI, Google Scholar, ProQuest, Emerald Insight, ACM were searched to understand what particular aspect of information security and privacy in digital libraries exist from 2000 - 2010. Security in digital libraries is an issue of the most important, and should be considered carefully in creating policies and strategic plans of institutions wanting to set up a digital library. This paper focused on the four main streams that concerns security in the digital environment, namely: infrastructure, digital content, users and standards and legal issues. This literature review also built upon previous literature reviews, and is one of the few of its kind in the topic. / Bu çalışma dijital kütüphanelerin kaynakların yönetiminde göz önünde bulundurmasıgereken güvenlik sorunlarına ilişkin literatürü ortaya koymayı amaçlamaktadır. Bilgi Güvenliği, Ağ Güvenliği, Kişisel Gizlilik konuları üzerine 2000 - 2010 yıl aralığını kapsayan kitaplar ve makaleler ERIC, Ebrary, LISA, Science Direct, EbscoHost, ISI, Google Akademik, ProQuest, Emerald Insight ve ACM gibi çeşitli veri tabanlarından taranmıştır. İncelenen literatürden elde edilen sonuçlara göre,bilgi güvenliği dijital kütüphaneler için son derece önemli bir konudur ve dijitalleşme sürecinde bir kütüphane, güvenlik politikalarını ve stratejik planlarını dikkatle göz önünde bulundurmalıdır. Bu araştırmada dijital ortamda güvenliği ilgilendiren Altyapı, Dijital İçerik, Kullanıcılar, Standartlar ve Hukuki Konular olmak üzere dört ana madde üzerinde durulmuştur. Bu çalışma ayrıca daha önceki literatür taramalarını da kapsamaktadır.

[Peranesthesic Anaphylactic Shocks: Contribution of a Clinical Data Warehouse].

Science.gov (United States)

Osmont, Marie-Noëlle; Campillo-Gimenez, Boris; Metayer, Lucie; Jantzem, Hélène; Rochefort-Morel, Cécile; Cuggia, Marc; Polard, Elisabeth

2015-10-16

To evaluate the performance of the collection of cases of anaphylactic shock during anesthesia in the Regional Pharmacovigilance Center of Rennes and the contribution of a query in the biomedical data warehouse of the French University Hospital of Rennes in 2009. Different sources were evaluated: the French pharmacovigilance database (including spontaneous reports and reports from a query in the database of the programme de médicalisation des systèmes d'information [PMSI]), records of patients seen in allergo-anesthesia (source considered as comprehensive as possible) and a query in the data warehouse. Analysis of allergo-anesthesia records detected all cases identified by other methods, as well as two other cases (nine cases in total). The query in the data warehouse enabled detection of seven cases out of the nine. Querying full-text reports and structured data extracted from the hospital information system improves the detection of anaphylaxis during anesthesia and facilitates access to data. © 2015 Société Française de Pharmacologie et de Thérapeutique.

Internet of Things (IoT) Applicability in a Metropolitan City

OpenAIRE

Dr. D Mohammed

2015-01-01

Internet of Things (IoT)is defined here as a network of interconnected objects. These objects can include several technological systems. This paper examines the wireless communication systems and IoT sensors. IoT is technically feasible today, allowing people and things to be connected anytime, anyplace, with anything and anyone. IoT privacy is a concern but security solutions exist today to solve these issues. A proposal is made to use secure IoT solutions in supporting the metropolitan need...

The nuclear controversy-what are the issues

International Nuclear Information System (INIS)

Wyatt, A.

1976-01-01

The various issues raised by anti-nuclear groups are outlined and rebutted. Issues are grouped under four headingss - Economic; Technical; Social/Ethical/Moral; Political. Issues debated under economic aspects include conservation, unemployment resulting from energy use, use of alternative enrgy sources, high capital cost of nuclear power, high energy consumption in construction of plants, performance unreliability, depletion of uranium and excessive cost of decommissioning. Technically related issues, reactor safety, possibility of nuclear power plant explosion, waste managment, toxicity of plutonium, emission of radioactive material, thermal pollution and environmental effect of heavy water production are also discussed. Social/ethical/moral issues rebutted include radiation effects on health and genetic effects, deaths among uranium miners, morality of long-term waste storage, lack of faith in technical solutions and technical people, opposition to current life style, secrecy of information, nuclear proliferation and unsuitability of nuclear technology to the needs of developing countries. Political issues discussed are sabotage/terrorism possibilites, police state tactics in protection of nuclear facilities, misuse of technolgy by society, high energy society is capitalist and low energy society is Marxist, centralization of power, need for a great nuclear debate and the question of who pays for safety. Scientists and technical people are called upon to debate in their areas of specialty and are cautioned to be aware of tactics involved in meeting challengers head-on. (J.T.A.)

The scientific case for a JET D-T experiment

International Nuclear Information System (INIS)

Weisen, H.; Sips, A. C. C.; Horton, L. D.; Challis, C. D.; Sharapov, S. E.; Zastrow, K.-D.; Eriksson, L.-G.; Batistoni, P.

2014-01-01

After the first high power D-T experiment in JET in 1997 (DTE1), when JET was equipped with Carbon PFC's, a proposed second high power (up to ∼40MW) D-T campaign (DTE2) in the current Be/W vessel will address essential operational, technical, diagnostics and scientific issues in support of ITER. These experiments are proposed to minimize the risks to ITER by testing strategies for the management of the in-vessel tritium content, by providing the basis for transferring operational scenarios from non-active operation to D-T mixtures and by addressing the issue of the neutron measurement accuracy. Dedicated campaigns with operation in Deuterium, Hydrogen and Tritium before the D-T campaign proper will allow the investigation of isotope scaling of the H-mode transition, pedestal physics, heat, particle, momentum and impurity transport in much greater detail than was possible in DTE1. The D-T campaign proper will include validations of the baseline ELMy H-Mode scenario, of the hybrid H-mode and advanced tokamak scenarios, as well as the investigation of alpha particle physics and the qualification of ICRH scenarios suitable for D-T operation. This paper reviews the scientific goals of DTE2 together with a summary of the results of DTE1

Clipboard: Putting T cells to sleep: a new paradigm for immune ...

Indian Academy of Sciences (India)

2006-11-13

Nov 13, 2006 ... Home; Journals; Journal of Biosciences; Volume 31; Issue 5. Clipboard: Putting T cells to sleep: a new paradigm for immune evasion by persistent viruses. Shweta Dubey Shahid Jameel. Volume 31 Issue 5 December 2006 pp 497-501 ...

Severe accidents and ESFR design issues

International Nuclear Information System (INIS)

Rineiski, A.

2013-01-01

Current SFR studies in Germany: ⇒ In support of European SFR studies, mainly on safety and safety-related (design optimization) issues; ⇒ ADS and SFR as main options for spent fuel management in studies on the possibility of P&T; ⇒ ESFR-type designs studied recently; ⇒ ASTRID-type designs to be studied in the future; ⇒ Particular area: modeling of severe accidents with SAS4A/SAS-SFR and SIMMER codes

Can't Curb the Urge to Move? Living with Restless Legs Syndrome

Science.gov (United States)

... Special Issues Subscribe October 2012 Print this issue Can’t Curb the Urge to Move? Living With ... for people with restless legs syndrome. The condition can cause throbbing, pulling or creeping sensations in the ...

Sample size of the reference sample in a case-augmented study.

Science.gov (United States)

Ghosh, Palash; Dewanji, Anup

2017-05-01

The case-augmented study, in which a case sample is augmented with a reference (random) sample from the source population with only covariates information known, is becoming popular in different areas of applied science such as pharmacovigilance, ecology, and econometrics. In general, the case sample is available from some source (for example, hospital database, case registry, etc.); however, the reference sample is required to be drawn from the corresponding source population. The required minimum size of the reference sample is an important issue in this regard. In this work, we address the minimum sample size calculation and discuss related issues. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

In vivo determination of T1 and T2 in the brain of patients with severe but stable multiple sclerosis

DEFF Research Database (Denmark)

Larsson, H B; Frederiksen, J; Kjaer, L

1988-01-01

investigated, using a whole-body superconductive MR scanner, operating at 1.5 T. By employing 12-point (or 6-point) partial saturation inversion recovery (PSIR) and 32-echo multiple spin-echo sequences we measured T1 and T2 in MS plaques, white matter, and cortical gray matter. We also focused on the issue......, whether T1 and T2 relaxation processes in fact were monoexponential. T1 and T2 in plaques were found to cover a wide range, which could be explained only by inherent biophysical dissimilarity of the plaques, possibly due to differences in disease activity, edema and gliosis. T1 appeared monoexponential...... in all the plaques, but in seven cases T2 showed biexponential behavior. This was found to be most pronounced near the cerebrospinal fluid of the ventricles, probably caused by partial volume effects or increased free water content. The T2 of apparently normal white matter was significantly longer in MS...

Adoptive T cell therapy: Addressing challenges in cancer immunotherapy

Directory of Open Access Journals (Sweden)

Yee Cassian

2005-04-01

Full Text Available Abstract Adoptive T cell therapy involves the ex vivo selection and expansion of effector cells for the treatment of patients with cancer. In this review, the advantages and limitations of using antigen-specific T cells are discussed in counterpoint to vaccine strategies. Although vaccination strategies represent more readily available reagents, adoptive T cell therapy provides highly selected T cells of defined phenotype, specificity and function that may influence their biological behavior in vivo. Adoptive T cell therapy offers not only translational opportunities but also a means to address fundamental issues in the evolving field of cancer immunotherapy.

Current Issues in Finite-T Density-Functional Theory and Warm-Correlated Matter †

Directory of Open Access Journals (Sweden)

M. W. C. Dharma-wardana

2016-03-01

Full Text Available Finite-temperature density functional theory (DFT has become of topical interest, partly due to the increasing ability to create novel states of warm-correlated matter (WCM.Warm-dense matter (WDM, ultra-fast matter (UFM, and high-energy density matter (HEDM may all be regarded as subclasses of WCM. Strong electron-electron, ion-ion and electron-ion correlation effects and partial degeneracies are found in these systems where the electron temperature Te is comparable to the electron Fermi energy EF. Thus, many electrons are in continuum states which are partially occupied. The ion subsystem may be solid, liquid or plasma, with many states of ionization with ionic charge Zj. Quasi-equilibria with the ion temperature Ti ≠ Te are common. The ion subsystem in WCM can no longer be treated as a passive “external potential”, as is customary in T = 0 DFT dominated by solid-state theory or quantum chemistry. Many basic questions arise in trying to implement DFT for WCM. Hohenberg-Kohn-Mermin theory can be adapted for treating these systems if suitable finite-T exchange-correlation (XC functionals can be constructed. They are functionals of both the one-body electron density ne and the one-body ion densities ρj. Here, j counts many species of nuclei or charge states. A method of approximately but accurately mapping the quantum electrons to a classical Coulomb gas enables one to treat electron-ion systems entirely classically at any temperature and arbitrary spin polarization, using exchange-correlation effects calculated in situ, directly from the pair-distribution functions. This eliminates the need for any XC-functionals. This classical map has been used to calculate the equation of state of WDM systems, and construct a finite-T XC functional that is found to be in close agreement with recent quantum path-integral simulation data. In this review, current developments and concerns in finite-T DFT, especially in the context of non-relativistic warm

Don't Panic! | NIH MedlinePlus the Magazine

Science.gov (United States)

... of this page please turn Javascript on. Feature: Phobias and Anxiety Disorders Don't Panic! Past Issues / Fall 2010 Table of Contents Phobias and other anxiety disorders affect millions of Americans. ...

Transitioning from first- to second-generation biosimilars: An appraisal of regulatory and post-marketing challenges.

Science.gov (United States)

Blandizzi, Corrado; Galeazzi, Mauro; Valesini, Guido

2018-02-01

Second-generation biosimilars (i.e. monoclonal antibodies or proteins generated by fusion of antibody and receptor moieties) differ in several respects as compared to first-generation ones (e.g. epoetins, bone marrow stimulating factors, somatotropins). In this respect, as second-generation biosimilars are endowed with much greater structural and molecular complexity, which might translate into a number of pharmacological and therapeutic issues, they raise new challenges for manufacturers and regulatory authorities as well as new concerns for clinicians. Based on these arguments, the present article was intended to review information on the main differences between first- and second-generation biosimilars for treatment of immune-mediated inflammatory diseases, as well as their impact on immunogenicity, the design of clinical trials and the critical issue of extrapolation of therapeutic indications. The positions taken by relevant medical associations and the crucial role of pharmacovigilance are also reviewed. According to current knowledge, the initial post-marketing clinical experience with second-generation biosimilars is providing encouraging results, though their long-term safety and efficacy as well as the scientific basis underlying the extrapolation of therapeutic indications are still matter of discussion. There is some consensus that marketing applications should rely on studies supporting the clinical use of biosimilars in their different target diseases and patient populations. In parallel, clinical safety must be ensured by a strict control of the manufacturing processes and a solid pharmacovigilance program. It remains then a responsibility of the physician to drive a proper use of second-generation biosimilars into clinical practice, in accordance with guidelines issued by scientific societies. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

The concept of adverse drug reaction reporting: awareness among pharmacy students in a Nigerian university

Directory of Open Access Journals (Sweden)

Johnson Segun Showande

2013-01-01

Full Text Available Adverse drug reaction (ADR is poorly reported globally but more in developing countries with poor participation by health professionals. Currently, there is no known literature on the Nigerian pharmacy students’ knowledge on ADR reporting. Hence the purpose of this study was to find out the level of knowledge of pharmacy students on the concept of pharmacovigilance and adverse drug reaction reporting and also to evaluate their opinions on the National Pharmacovigilance Centre guidelines on adverse drug reaction reporting. A pretested 34-item semi-structured questionnaire was administered among 69 pharmacy undergraduate students in their penultimate and final years that consented to take part in the study, in one of the universities in Nigeria. The study was carried out strictly adhering to the principles outlined in the Helsinki declaration of 1964, which was revised in 1975. The questionnaire used had four sections which included a section on biographical data, a section which evaluated the students knowledge on the concept of pharmacovigilance and adverse drug reaction reporting, a section on students personal experiences of adverse drug reactions and modes of reporting them and the final section of the questionnaire evaluated the students’ opinions on the National Pharmacovigilance Centre guidelines for reporting adverse drug reactions. Descriptive statistics, Mann-Whitney U and Kruskal Wallis statistical tests were used to analyze the data obtained. None of the participants knew the sequence of reporting ADR. More than half, 40(58.0% had heard about pharmacovigilance at symposiums, 7(10.1% during clinical clerkship program and 18(26.1% from media jingles. Twenty nine (42.0% agreed that pharmacovigilance was in their curriculum, however only 16(23.2% could define the term correctly. None of the participants had seen or used an ADR form prior to the study, but the students could easily identify and describe the type of ADR they had

2018-02-16T08:30:28Z https://www.ajol.info/index.php/index/oai oai ...

African Journals Online (AJOL)

article/55618 2018-02-16T08:30:28Z mlr:ART Abortion law in Ethiopia: a comparative perspective Wada, T Induced abortion or the deliberate termination of pregnancy is one of the most controversial issues in legal discourse. As a legal issue, ...

Don't Sweat the Small Stuff: Food Allergy Sufferer Lives a Cautious but Normal Life

Science.gov (United States)

... Current Issue Past Issues Home Current issue contents Food allergy sufferer lives a cautious but normal life Follow us Don’t Sweat the Small Stuff Food allergy sufferer lives a cautious but normal life Anthony ...

Another time point, a different story: one year effects of a social media intervention on the attitudes of young people towards mental health issues.

Science.gov (United States)

Livingston, James D; Cianfrone, Michelle; Korf-Uzan, Kimberley; Coniglio, Connie

2014-06-01

This study extends an evaluation of a brief, social media intervention, called In One Voice, for raising mental health awareness and improving attitudes of youth and young adults towards mental health issues. A successive independent samples design assessed market penetration and attitudinal changes among the young people who completed an online questionnaire 1 year after (T3: n = 438) the intervention. This is compared with two samples that completed a survey either immediately before (T1: n = 403) or 2 months after (T2: n = 403) the campaign launch. The proportion of respondents who remembered the campaign grew from 24.8 % at T2 to 48.6 % at T3. Elevated website activity on mindcheck.ca was sustained 1 year after In One Voice had ended. Small but significant reductions in personal stigma and social distance were detected from T1 and T3, which were not observed at T2. Respondents' self-rated ability to help others with mental health issues and to engage in positive behaviors relating to mental health issues (e.g., seeking information) did not improve significantly from T1 to T3. Improved attitudes towards mental health issues were observed among young people 1 year following a brief social media campaign. The campaign was less effective at providing the tools young people need to feel capable of helping someone who may be experiencing mental health issues, and motivating them to engage in constructive behaviors related to mental health.

The myth of the warrior: martial masculinity and the end of Don't Ask, Don't Tell.

Science.gov (United States)

Allsep, L Michael

2013-01-01

The image of the male warrior still dominates military culture, to the exclusion of women and homosexuals. Complicating the picture is a technological revolution that promises to widen the current gap between the myth and reality of the modern warrior even further. Nonetheless, despite long arguing that homosexuals were a direct threat to military culture and effectiveness, the Pentagon has largely treated the end of Don't Ask, Don't Tell as a policy matter. The difficulties still experienced by women in the armed services 40 years after they were first incorporated in significant numbers indicates that this response will be insufficient to address the deeper cultural issues. Gender issues implicate deeply held beliefs and values that persist even in the face of years of official admonishment and denial. Unless the military begins to transparently bridge the gap between the myth and reality of the modern warrior, military service without discrimination based on sexual orientation will remain an unachieved goal.

On Kasner solution in Bianchi I f( T) cosmology

Science.gov (United States)

Skugoreva, Maria A.; Toporensky, Alexey V.

2018-05-01

Recently the cosmological dynamics of an anisotropic Universe in f( T) gravity became an area of intense investigations. Some earlier papers devoted to this issue contain contradictory claims about the nature and propertied of vacuum solutions in this theory. The goal of the present paper is to clarify this situation. We compare properties of f( T) and f( R) vacuum solutions and outline differences between them. The Kasner solution appears to be an exact solution for the T=0 branch, and an asymptotic solution for the T ≠ 0 branch. It is shown that the Kasner solution is a past attractor if Tpast and future attractor for the T>0 branch.

Flexible mixture modeling via the multivariate t distribution with the Box-Cox transformation: an alternative to the skew-t distribution.

Science.gov (United States)

Lo, Kenneth; Gottardo, Raphael

2012-01-01

Cluster analysis is the automated search for groups of homogeneous observations in a data set. A popular modeling approach for clustering is based on finite normal mixture models, which assume that each cluster is modeled as a multivariate normal distribution. However, the normality assumption that each component is symmetric is often unrealistic. Furthermore, normal mixture models are not robust against outliers; they often require extra components for modeling outliers and/or give a poor representation of the data. To address these issues, we propose a new class of distributions, multivariate t distributions with the Box-Cox transformation, for mixture modeling. This class of distributions generalizes the normal distribution with the more heavy-tailed t distribution, and introduces skewness via the Box-Cox transformation. As a result, this provides a unified framework to simultaneously handle outlier identification and data transformation, two interrelated issues. We describe an Expectation-Maximization algorithm for parameter estimation along with transformation selection. We demonstrate the proposed methodology with three real data sets and simulation studies. Compared with a wealth of approaches including the skew-t mixture model, the proposed t mixture model with the Box-Cox transformation performs favorably in terms of accuracy in the assignment of observations, robustness against model misspecification, and selection of the number of components.

Analysis of concentrating PV-T systems for the commercial/industrial sector. Volume II. PV-T state-of-the-art survey and site/application pair selection and analysis

Energy Technology Data Exchange (ETDEWEB)

Schwinkendorf, W.E.

1984-09-01

As part of a project to develop feasibility assessments, design procedures, and reference designs for total energy systems that could use actively cooled concentrating photovoltaic collectors, a survey was conducted to provide an overview of available photovoltaic-thermal (PV-T) technology. General issues associated with the design and installation of a PV-T system are identified. Electrical and thermal efficiencies for the line-focus Fresnel, the linear parabolic trough, and the point-focus Fresnel collectors are specified as a function of operating temperature, ambient temperature, and insolation. For current PV-T technologies, the line-focus Fresnel collector proved to have the highest thermal and electrical efficiencies, lowest array cost, and lowest land area requirement. But a separate feasibility analysis involving 11 site/application pairs showed that for most applications, the cost of the photovoltaic portion of a PV-T system is not recovered through the displacement of an electrical load, and use of a thermal-only system to displace the thermal load would be a more economical alternative. PV-T systems are not feasible for applications that have a small thermal load, a large steam requirement, or a high load return temperature. SAND82-7157/3 identifies the technical issues involved in designing a photovoltaic-thermal system and provides guidance for resolving such issues. Detailed PV-T system designs for three selected applications and the results of a trade-off study for these applications are presented in SAND82-7157/4. A summary of the major results of this entire study and conclusions concerning PV-T systems and applications is presented in SAND82-7157/1.

An evaluation of knowledge, attitude and practice of Indian pharmacists towards adverse drug reaction reporting: A pilot study

Directory of Open Access Journals (Sweden)

Akram Ahmad

2013-01-01

Full Text Available Background: Pharmacovigilance is a useful to assure the safety of medicines and protect consumers from their harmful effects. Healthcare professionals should consider Adverse Drug Reaction (ADR reporting as part of their professional obligation and participate in the existent pharmacovigilance programs in their countries. In India, the National PV Program was re-launched in July 2010. Objectives: This survey was conducted in order to assess the knowledge, attitude and practice of Indian pharmacists with the aim of exploring the pharmacists′ participation in ADR reporting system, identifying the reasons of under reporting and determining the steps that could be adopted to increase reporting rates. Materials and Methods: A cross-sectional survey was carried out among the pharmacists in India using a pretested questionnaire with 33 questions (10 questions on knowledge, 6 on attitude, 7 on practice, 7 on future of ADR reporting in India and 3 on benefits of reporting ADRs.. The study was conducted, over a period of 3 months from May 2012 to July 2012. Results: Out of the 600 participants to whom the survey was administered, a total of 400 were filled. The response rate of the survey was 67%. 95% responders were knowledgeable about ADRs. 90% participants had a positive attitude towards making ADRs reporting mandatory for practicing pharmacists. 87.5% participants were interested in participating in the National Pharmacovigilance program, in India. 47.5% respondents had observed ADRs in their practice, and 37% had reported it to the national pharmacovigilance center. 92% pharmacists believed reporting ADRs immensely helped in providing quality care to patients. Conclusion : The Indian pharmacists have poor knowledge, attitude, and practice (KAP towards ADR reporting and pharmacovigilance. Pharmacists with higher qualifications such as the pharmacists with a PharmD have better KAP. With additional training on Pharmacovigilance, the Indian Pharmacists

Medication safety knowledge, attitudes and practices among community pharmacists in Lebanon.

Science.gov (United States)

Hajj, Aline; Hallit, Souheil; Ramia, Elsy; Salameh, Pascale

2018-01-01

The effectiveness of a national post-marketing surveillance program depends directly on the active participation of all health professionals. There is no current comprehensive and active pharmacovigilance program available in Lebanon. To assess the knowledge, attitudes, and practices (KAP) among community pharmacists in Lebanon with respect to potential pharmacovigilance and adverse-drug-reaction reporting in Lebanon. A cross-sectional descriptive study, using a self-administered KAP questionnaire and conducted between March and July 2016, included 1857 pharmacists practicing in community settings. Statistical analysis included χ 2 test for dichotomous or multinomial qualitative variables, and Wilcoxon test for quantitative variables with non-homogeneous variances or non-normal distribution. The majority of responders had good knowledge concerning the concept and purpose of pharmacovigilance as well as adverse drug reactions (how to report these/the importance of reporting adverse events/the definition of an adverse event and pharmacovigilance). Concerning community pharmacists' attitudes and practice towards pharmacovigilance, the majority described having a positive attitude towards their role in adverse drug reaction reporting and this activity was even seen as one of their core duties. The questionnaire revealed a lack of practice and training regarding pharmacovigilance. Nonetheless, the pharmacists agreed on the Order of Pharmacists in Lebanon and the Ministry of Health's role in promoting this practice and helping them be more involved in reporting adverse drug reactions (ADRs). The pharmacists thought that they are well positioned regarding patient-safety practice in their pharmacies and the results were not statistically different between pharmacy employers and employees. Lebanese pharmacists have the required knowledge and positive attitude to start reporting ADRs, were aware of ADRs occurring with various medicines post-marketing, yet were currently not

Nuclear Issues in the Post-September 11 era

International Nuclear Information System (INIS)

Dunn, Lewis; Wheeler, Michael; May, Michael; Pikayev, Alexander; Wolfstahl, Jon; Roberts, Brad; Tertrais, Bruno; Umbach, Frank

2003-03-01

In the fall of 2002, the Foundation for Strategic Research convened a small group of high-level experts on nuclear policy issues to discuss the consequences of September 11 and of the 'war on terrorism' for nuclear debates. Participants met in Paris on September 26-27, 2002, and later provided papers which are reproduced here. This project was sponsored by the French Commissariat a l'Energie Atomique (CEA). Contents: 1 - Nuclear Issues in the Post-September 11 era: emerging Trends (Bruno Tertrais); 2 - Nuclear energy Issues: Global Dimensions and Security Challenges (Frank Umbach); 3 - Proliferation and Non-Proliferation: What's Changed-What Hasn't? (Jon B. Wolfstahl); 4 - Non-Proliferation: Possible New Trends after September 11 (Alexander A. Pikayev); 5 - Nuclear Deterrence Issues in the Post-September 11 World: An American Perspective (Michael O. Wheeler); 6 - The Nuclear Balance of Terror and September 11 (Brad Roberts); 7 - Nuclear Weapons after September 11 (Lewis A. Dunn); 8 - September 11 and the Need for International Nuclear Agreements (Michael May)

Special issue on electron cyclotron wave physics, technology, and applications - Part 2

International Nuclear Information System (INIS)

Uckan, Nermin A.

2008-01-01

This issue of Fusion Science and Technology (FS and T) contains a compendium of full-length, peer-reviewed papers on electron cyclotron (EC) wave physics, technology, and applications on magnetically confined plasmas. The interest in this special issue started with a simple question from a single individual who asked if he could submit for publication in FS and T his paper ''ITER ECH Front Steering Upper Launcher,'' parts of which he was planning to present at the 14th Joint Workshop on Electron Cyclotron Emission and Electron Cyclotron Resonance Heating, Santorini Island, Greece, May 2006. Such interest quickly grew, and the decision was made to offer the same opportunity to other workshop participants as well as to other interested researchers from around the world to contribute to a special FS and T issue on EC wave physics, technology, and applications. The person who started this ''wave'' of interest is no other than Dr. Mark Henderson, who was later drafted and kindly agreed to serve as the guest editor for this issue. The worldwide research program on EC wave physics, technology, and applications has shown impressive progress over the past couple of years, and much of this progress is reflected in the fifty or so papers that are included in this two-part special issue - part 1 in August 2007 and part 2 in January 2008. To complement the contributed papers, several informative reviews, which will be valuable for years to come, were also invited and are included. These review papers provide an objective summary of the current state of the art in EC emission research, theory of EC waves, EC heating and current drive experiments, gyrotron development, launcher development, and transmission systems. In preparation for ITER, this special issue is timely and should be of interest to those already working in the field and to the new generation of scientists and engineers who will be the ones to design, build, and carry out experiments on ITER. We extend our

Economics of Internet of Things (IoT): An Information Market Approach

OpenAIRE

Niyato, D.; Lu, X.; Wang, P.; Kim, D. I.; Han, Z.

2015-01-01

Internet of things (IoT) has been proposed to be a new paradigm of connecting devices and providing services to various applications, e.g., transportation, energy, smart city, and healthcare. In this paper, we focus on an important issue, i.e., economics of IoT, that can have a great impact to the success of IoT applications. In particular, we adopt and present the information economics approach with its applications in IoT. We first review existing economic models developed for IoT services....

IoT-Based Smart Garbage System for Efficient Food Waste Management

Directory of Open Access Journals (Sweden)

Insung Hong

2014-01-01

Full Text Available Owing to a paradigm shift toward Internet of Things (IoT, researches into IoT services have been conducted in a wide range of fields. As a major application field of IoT, waste management has become one such issue. The absence of efficient waste management has caused serious environmental problems and cost issues. Therefore, in this paper, an IoT-based smart garbage system (SGS is proposed to reduce the amount of food waste. In an SGS, battery-based smart garbage bins (SGBs exchange information with each other using wireless mesh networks, and a router and server collect and analyze the information for service provisioning. Furthermore, the SGS includes various IoT techniques considering user convenience and increases the battery lifetime through two types of energy-efficient operations of the SGBs: stand-alone operation and cooperation-based operation. The proposed SGS had been operated as a pilot project in Gangnam district, Seoul, Republic of Korea, for a one-year period. The experiment showed that the average amount of food waste could be reduced by 33%.

IoT-based smart garbage system for efficient food waste management.

Science.gov (United States)

Hong, Insung; Park, Sunghoi; Lee, Beomseok; Lee, Jaekeun; Jeong, Daebeom; Park, Sehyun

2014-01-01

Owing to a paradigm shift toward Internet of Things (IoT), researches into IoT services have been conducted in a wide range of fields. As a major application field of IoT, waste management has become one such issue. The absence of efficient waste management has caused serious environmental problems and cost issues. Therefore, in this paper, an IoT-based smart garbage system (SGS) is proposed to reduce the amount of food waste. In an SGS, battery-based smart garbage bins (SGBs) exchange information with each other using wireless mesh networks, and a router and server collect and analyze the information for service provisioning. Furthermore, the SGS includes various IoT techniques considering user convenience and increases the battery lifetime through two types of energy-efficient operations of the SGBs: stand-alone operation and cooperation-based operation. The proposed SGS had been operated as a pilot project in Gangnam district, Seoul, Republic of Korea, for a one-year period. The experiment showed that the average amount of food waste could be reduced by 33%.

IoT-Based Smart Garbage System for Efficient Food Waste Management

Science.gov (United States)

Lee, Jaekeun

2014-01-01

Owing to a paradigm shift toward Internet of Things (IoT), researches into IoT services have been conducted in a wide range of fields. As a major application field of IoT, waste management has become one such issue. The absence of efficient waste management has caused serious environmental problems and cost issues. Therefore, in this paper, an IoT-based smart garbage system (SGS) is proposed to reduce the amount of food waste. In an SGS, battery-based smart garbage bins (SGBs) exchange information with each other using wireless mesh networks, and a router and server collect and analyze the information for service provisioning. Furthermore, the SGS includes various IoT techniques considering user convenience and increases the battery lifetime through two types of energy-efficient operations of the SGBs: stand-alone operation and cooperation-based operation. The proposed SGS had been operated as a pilot project in Gangnam district, Seoul, Republic of Korea, for a one-year period. The experiment showed that the average amount of food waste could be reduced by 33%. PMID:25258730

Report of the Comprehensive Review of the Issues Associated with a Repeal of ’Don’t Ask, Don’t Tell’

Science.gov (United States)

2010-11-30

Secretary of Defense, Racial and Gender Intergration of the Armed Forces, August 9, 2010, 5–6. 23 Matthew Cashdollar, “Not Yes or No, But What If...implement repeal of Don’t Ask, Don’t Tell consistent with their unique service cultures, 2) education and training products should be simple and should... products . The Working Group later undertook leadership engagement visits to the Service Training and Education Commands. Between May and October, the

Tank characterization report for single-shell tank 241-T-104

International Nuclear Information System (INIS)

DiCenso, A.T.; Simpson, B.C.

1994-01-01

In August 1992, Single-Shell Tank 241-T-104 was sampled to determine proper handling of the waste, to address corrosivity and compatibility issues, and to comply with requirements of the Washington Administrative Code (Ecology, 1991). This Tank Characterization Report presents an overview of that tank sampling and analysis effort, and contains observations regarding waste characteristics. It also addresses expected concentration and bulk inventory data for the waste contents based on this latest sampling data and background tank information. The purpose of this report is to describe and characterize the waste in Single-Shall Tank 241-T-104 (hereafter, Tank 241-T-104) based on information given from various sources. This report summarizes the available information regarding the waste in Tank 241-T-104, and using the historical information to place the analytical data in context, arranges this information in a useful format for making management and technical decisions concerning this waste tank. In addition, conclusions and recommendations are given based on safety issues and further characterization needs

The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis.

Science.gov (United States)

Rolfes, Leàn; van Hunsel, Florence; van der Linden, Laura; Taxis, Katja; van Puijenbroek, Eugène

2017-07-01

Clinical information is needed to assess the causal relationship between a drug and an adverse drug reaction (ADR) in a reliable way. Little is known about the level of relevant clinical information about the ADRs reported by patients. The aim was to determine to what extent patients report relevant clinical information about an ADR compared with their healthcare professional. A retrospective analysis of all ADR reports on the same case, i.e., cases with a report from both the patient and the patient's healthcare professional, selected from the database of the Dutch Pharmacovigilance Center Lareb, was conducted. The extent to which relevant clinical information was reported was assessed by trained pharmacovigilance assessors, using a structured tool. The following four domains were assessed: ADR, chronology, suspected drug, and patient characteristics. For each domain, the proportion of reported information in relation to information deemed relevant was calculated. An average score of all relevant domains was determined and categorized as poorly (≤45%), moderately (from 46 to 74%) or well (≥75%) reported. Data were analyzed using a paired sample t test and Wilcoxon signed rank test. A total of 197 cases were included. In 107 cases (54.3%), patients and healthcare professionals reported a similar level of clinical information. Statistical analysis demonstrated no overall differences between the groups (p = 0.126). In a unique study of cases of ADRs reported by patients and healthcare professionals, we found that patients report clinical information at a similar level as their healthcare professional. For an optimal pharmacovigilance, both healthcare professionals and patient should be encouraged to report.

Introduction to a special issue on genotype by environment interaction

Science.gov (United States)

Expression of a phenotype is a function of the genotype, the environment, and the differential sensitivity of certain genotypes to different environments, also known as genotype by environment (G × E) interaction. This special issue of Crop Science includes a collection of manuscripts that reviews t...

Trans issues in Liz Lochhead's 'Not Changed'

OpenAIRE

Kaličanin Milena M.

2017-01-01

The paper is divided into four sections. In the first section entitled 'Introducing and Defining Trans (Issues)', the basic terms of transgender, transvestite, and transsexual are defined by relying on Stryker's Transgender History (2008). The second part of the paper, 'Trans Studies: In-Between Feminist and Queer Theory?', places transgender studies into an academic context by referring to the theoretical framework provided by trans theorists Stryker, Stone, and Ranck who unanimously claim t...

TOP issues expected to leave center stage during 1991

International Nuclear Information System (INIS)

Anon.

1991-01-01

American Gas Association Chairman William T. McCormick gives his views on the resolution of the take-or-pay problems, supply problems of LDCs, effect of gas imports and exports, and random drug testing. Mr. McCormick, chairman and CEO of EMS Energy Corp., also discusses other significant gas industry issues in this interview

F actors Affecting Non Bank - Issued POS E - microp a ym en t Choice: A Study of Taiwan Market

OpenAIRE

Wee Kheng Tan; Shih Kuo Chen

2008-01-01

I n Taiwan , o rgani z ations with existing captive markets, that is, transport - related companies and convenience stores, have issue d their own non bank - issued POS e - micro payment programs and achieve d good success. Due to legal restriction imposed on non bank - issued programs, Taiwan’s market has evolve d further resulting in two major categories: non bank - iss...

Immunotherapy in metastatic prostate cancer

Directory of Open Access Journals (Sweden)

Susan F Slovin

2016-01-01

Full Text Available Introduction: Prostate cancer remains a challenge as a target for immunological approaches. The approval of the first cell-based immune therapy, Sipuleucel-T for prostate cancer introduced prostate cancer as a solid tumor with the potential to be influenced by the immune system. Methods: We reviewed articles on immunological management of prostate cancer and challenges that lie ahead for such strategies. Results: Treatments have focused on the identification of novel cell surface antigens thought to be unique to prostate cancer. These include vaccines against carbohydrate and blood group antigens, xenogeneic and naked DNA vaccines, and pox viruses used as prime-boost or checkpoint inhibitors. No single vaccine construct to date has resulted in a dramatic antitumor effect. The checkpoint inhibitor, anti-CTLA-4 has resulted in several long-term remissions, but phase III trials have not demonstrated an antitumor effect or survival benefit. Conclusions: Multiple clinical trials suggest that prostate cancer may not be optimally treated by single agent immune therapies and that combination with biologic agents, chemotherapies, or radiation may offer some enhancement of benefit.

Conference communication. Managing change in tourism destinations: Key issues and current trends.

OpenAIRE

Mariani, M.M.; Buhalis, Dimitrios; Longhi, C.; Vitouladiti, O.

2013-01-01

This conference communication illustrates the major outcomes emerging from the EIASM Conference on Tourism Management and Tourism Related Issues held in Nice (France), September 20-21, 2012. While a number of managerial issues pertaining to the tourism field were dealt with, this communication covers three specific areas of interest for destination management and marketing: (1) the increasing competition among tourism destinations and the rise and consolidation of BRIC countries as outbound t...

t4 Workshop Report*

Science.gov (United States)

Kleensang, Andre; Maertens, Alexandra; Rosenberg, Michael; Fitzpatrick, Suzanne; Lamb, Justin; Auerbach, Scott; Brennan, Richard; Crofton, Kevin M.; Gordon, Ben; Fornace, Albert J.; Gaido, Kevin; Gerhold, David; Haw, Robin; Henney, Adriano; Ma’ayan, Avi; McBride, Mary; Monti, Stefano; Ochs, Michael F.; Pandey, Akhilesh; Sharan, Roded; Stierum, Rob; Tugendreich, Stuart; Willett, Catherine; Wittwehr, Clemens; Xia, Jianguo; Patton, Geoffrey W.; Arvidson, Kirk; Bouhifd, Mounir; Hogberg, Helena T.; Luechtefeld, Thomas; Smirnova, Lena; Zhao, Liang; Adeleye, Yeyejide; Kanehisa, Minoru; Carmichael, Paul; Andersen, Melvin E.; Hartung, Thomas

2014-01-01

Summary Despite wide-spread consensus on the need to transform toxicology and risk assessment in order to keep pace with technological and computational changes that have revolutionized the life sciences, there remains much work to be done to achieve the vision of toxicology based on a mechanistic foundation. A workshop was organized to explore one key aspect of this transformation – the development of Pathways of Toxicity (PoT) as a key tool for hazard identification based on systems biology. Several issues were discussed in depth in the workshop: The first was the challenge of formally defining the concept of a PoT as distinct from, but complementary to, other toxicological pathway concepts such as mode of action (MoA). The workshop came up with a preliminary definition of PoT as “A molecular definition of cellular processes shown to mediate adverse outcomes of toxicants”. It is further recognized that normal physiological pathways exist that maintain homeostasis and these, sufficiently perturbed, can become PoT. Second, the workshop sought to define the adequate public and commercial resources for PoT information, including data, visualization, analyses, tools, and use-cases, as well as the kinds of efforts that will be necessary to enable the creation of such a resource. Third, the workshop explored ways in which systems biology approaches could inform pathway annotation, and which resources are needed and available that can provide relevant PoT information to the diverse user communities. PMID:24127042

The issue of the technical competence for the social worker A questão da competência técnica para o assistente social

Directory of Open Access Journals (Sweden)

Jolinda de Moraes Alves

1992-08-01

Full Text Available This article deals with the social work "professional competence'", emphasizing its technical and political dimension. Concerning to the social role and the professionals insertion on the social-technical division of labor, situated on the services section of the current monopolist stage oh capitalism; the established knowledge of the social work within the welfare organizations, beginning with the attributions. instruments and techniques; the contradiction of a profession witch has employment links with organisms created by the State and by the Capital, but should give services lo subalternized users and the actual meeting of the social demand put in by the users and the issue of the professional obligation with the rupture of their condition ofpoverty and subordination. Este artigo trabalha a "competência profissional" do assistente social, enfatizando suas dimensões técnica e política. Para tanto contempla: o papel e a inserção da profissão na divisão sócio-técnico do trabalho, localizada no setor de serviços do atual estágio monopolista do capitalismo; o saber instituído do assistente social no interior das instituições de bem estar social a partir das suas atribuições, instrumentos e técnicas; a contradição de uma profissão que tem vínculos empregatícios com organismos criados pelo Estado e pelo Capital, mas que deve prestar serviços a usuários subalternizados; e o efetivo compromisso com o atendimento à demanda social colocada pelo usuário institucional.

Teaching World History and Global Issues with the Internet

Science.gov (United States)

Risinger, C. Frederick

2011-01-01

In this article, the author recommends websites that include both traditional world history content and sites that focus on contemporary world issues and problems. The first two sites provide an intellectual stage for both world history and global studies. While they don't have lesson plans or links to other sites, they provide an understanding of…

Assessment of demyelination, edema, and gliosis by in vivo determination of T1 and T2 in the brain of patients with acute attack of multiple sclerosis

DEFF Research Database (Denmark)

Larsson, H B; Frederiksen, J; Petersen, J

1989-01-01

-body superconductive MR-scanner, operating at 1.5 T. The measurements were repeated several times, from onset of the disease and during remission by use of six-point partial saturation inversion recovery and 32-echo multiple spin-echo sequences, giving T1 and T2, respectively. We also focused on the issue, whether T1....... Hendriksen, and J. Olesen, Magn. Reson. Med. 7, 43 (1988)). In some of the acute plaques a slight initial increase in T1 and T2 was seen, when the measurement was repeated in about 10 days. Thereafter T1 decreased slowly in all but one patient as a function of days. In all cases the T1 relaxation process...

Waste compatibility safety issues and final results for tank 241-T-110 push mode samples

International Nuclear Information System (INIS)

Nuzum, J.L.

1997-01-01

This document is the final laboratory report for Tank 241-T-110. Push mode core segments were removed from risers 2 and 6 between January 29, 1997, and February 7, 1997. Segments were received and extruded at 222-S Laboratory. Analyses were performed in accordance with Tank 241-T-110 Push Mode Core Sampling and analysis Plan (TSAP) and Safety Screening Data Quality Objective (DQO). None of the subsamples submitted for total alpha activity (AT) or differential scanning calorimetry (DSC) analyses exceeded the notification limits stated in DQO

Modification of smoothing in 4253H[T

Science.gov (United States)

Azmi, Nurul Nisa'Khairol; Adam, Mohd Bakri; Shitan, Mahendran; Ali, Norhaslinda Mohd

2017-05-01

Some modified non-linear smoothers particularly 4253H[T] are explained in this paper. The modifications are focused on estimating the middle point of running median for even span by applying the following types of means; geometric, harmonic, quadratic and contraharmonic. The performance of the techniques is assessed by applying it to daily price index of a bank in Malaysia that issues sukuk for funding in Islamic banking and financial business. The results show that 4253H[T] with geometric mean modification is better than others in preserving variation and curve fitting.

An ignored and potential source of taste and odor (T&O) issues-biofilms in drinking water distribution system (DWDS).

Science.gov (United States)

Zhou, Xinyan; Zhang, Kejia; Zhang, Tuqiao; Li, Cong; Mao, Xinwei

2017-05-01

It is important for water utilities to provide esthetically acceptable drinking water to the public, because our consumers always initially judge the quality of the tap water by its color, taste, and odor (T&O). Microorganisms in drinking water contribute largely to T&O production and drinking water distribution systems (DWDS) are known to harbor biofilms and microorganisms in bulk water, even in the presence of a disinfectant. These microbes include T&O-causing bacteria, fungi, and algae, which may lead to unwanted effects on the organoleptic quality of distributed water. Importantly, the understanding of types of these microbes and their T&O compound-producing mechanisms is needed to prevent T&O formation during drinking water distribution. Additionally, new disinfection strategies and operation methods of DWDS are also needed for better control of T&O problems in drinking water. This review covers: (1) the microbial species which can produce T&O compounds in DWDS; (2) typical T&O compounds in DWDS and their formation mechanisms by microorganisms; (3) several common factors in DWDS which can influence the growth and T&O generation of microbes; and (4) several strategies to control biofilm and T&O compound formation in DWDS. At the end of this review, recommendations were given based on the conclusion of this review.

T-Duality for open strings

International Nuclear Information System (INIS)

Borlaf, J.

1997-01-01

We study T-duality for open strings in arbitrary background fields including the abelian electromagnetic one. We focus in the mapping of the boundary conditions in the disk and the crosscap topologies and we discuss in detail the consistency of the gauging procedure for the bosonic and the N = 1 supersymmetric theories. A brief account is made on the dilaton transformation and global issues in higher genus. (orig.)

Monitoring medicines use: the role of the clinical pharmacologist.

LENUS (Irish Health Repository)

Williams, David

2012-10-01

Appreciation of the potential of newly marketed medicines to produce both benefit and harm has increased the role of the clinical pharmacologist. Pharmacoepidemiology applies epidemiological reasoning, methods and knowledge to the study of the uses and effects of drugs in human populations. Pharmacovigilence identifies and then responds to safety issues about marketed drugs. Whilst adverse drug reaction (ADR) reporting systems can identify potential problems with drugs, determination of causation requires population-based studies of adverse events (including information from large clinical trials), which attempt to link unequivocally the adverse outcome to the drug in question. Pharmacovigilance is closely linked to postmarketing surveillance and is important for determining issues such as the long-term effects of drugs, identification of low-frequency ADRs, the effectiveness of drugs for their licensed indications or in new indications and other factors which may modify the efficacy and effectiveness of the drug in question. The related field of drug utilization developed in parallel with the study of adverse drug reactions, in recognition of the dramatic increase in the marketing of new drugs, the wide variations in the patterns and extent of drug prescribing, the growing concern about ADRs and the increasing costs of drugs. With the ever increasing number of recognized adverse effects of drugs, prescribing errors, patients\\' expectations concerning drug safety and the need for appropriate new drug appraisal, the clinical pharmacologist will play an important role both in the introduction of new drugs and in improving the safe and effective use of established drugs.

"Should I Stay or Should I Go?": Unpacking Teacher Attrition/Retention as an Educational Issue

Science.gov (United States)

Kelchtermans, Geert

2017-01-01

The paper starts from the observation that teacher attrition/retention seems to be a wicked issue: it seems to have strong face validity and a commonsense meaning, but the literature doesn't provide a clear and distinctive definition. In the first section, the author analyzes the different ways in which the issue of teacher attrition and retention…

Abdominal applications of 3.0-T MR imaging: comparative review versus a 1.5-T system.

Science.gov (United States)

Choi, Jin-Young; Kim, Myeong-Jin; Chung, Yong Eun; Kim, Ji Youn; Jones, Alun C; de Becker, Jan; van Cauteren, Marc

2008-01-01

With the development of dedicated receiver coils and increased gradient performance, 3.0-T magnetic resonance (MR) systems are gaining wider acceptance in clinical practice. The expected twofold increase in signal-to-noise ratio (SNR) compared with that of 1.5-T MR systems may help improve spatial resolution or increase temporal resolution when used with parallel acquisition techniques. Several issues must be considered when applying 3.0-T MR in the abdomen, including the alteration of the radiofrequency field and relaxation time, increase in energy deposition and susceptibility effects, and problems associated with motion artifacts. For the evaluation of liver lesions, higher SNR and greater resolution achieved with the 3.0-T system could translate into better detection of malignant lesions on T2-weighted images obtained with adjusted imaging parameters. For the evaluation of pancreatic and biliary diseases, high-resolution T2-weighted imaging using single-shot turbo spin-echo sequences is useful; improvement in SNR was noticeable on two-dimensional MR cholangiopancreatographic images. For the preoperative imaging of rectal cancer, a single-shot sequence is useful for dramatically decreasing imaging time while maintaining image quality. Substantial modification of examination protocols, with optimized imaging parameters and sequence designs along with ongoing development of hardware, could contribute to an increased role of the 3.0-T system for abdominal MR examinations.

Genetic polymorphisms of T-1131C APOA5 and ALOX5AP

Indian Academy of Sciences (India)

Home; Journals; Journal of Genetics; Volume 95; Issue 2. Genetic polymorphisms of T-1131C APOA5 and ALOX5AP SG13S114 with the susceptibility of ischemic stroke in Morocco. BREHIMA DIAKITE KHALIL HAMZI WIAM HMIMECH SELLAMA NADIFI GMRAVC. RESEARCH ARTICLE Volume 95 Issue 2 June 2016 pp ...

Tumor cells and memory T cells converge at glycolysis: Therapeutic implications

OpenAIRE

Karthikeyan, Swathi; Geschwind, Jean-Francois; Ganapathy-Kanniappan, Shanmugasundaram

2014-01-01

In the immune system, activation of naïve T (Tn) cells into effector T cells (Teff) involves a metabolic switch to glycolysis to promote rapid proliferation and differentiation. In the October issue of The Journal of Clinical Investigation, Sukumar et al. have demonstrated that in CD8+ memory T (Tems) cells glycolytic phenotype contributes to the shortened lifespan of Tems. Conversely, inhibition of glycolysis in Tems not only extended their viability but also augmented desirable properties. ...

New development in CAR-T cell therapy.

Science.gov (United States)

Wang, Zhenguang; Wu, Zhiqiang; Liu, Yang; Han, Weidong

2017-02-21

Chimeric antigen receptor (CAR)-engineered T cells (CAR-T cells) have yielded unprecedented efficacy in B cell malignancies, most remarkably in anti-CD19 CAR-T cells for B cell acute lymphoblastic leukemia (B-ALL) with up to a 90% complete remission rate. However, tumor antigen escape has emerged as a main challenge for the long-term disease control of this promising immunotherapy in B cell malignancies. In addition, this success has encountered significant hurdles in translation to solid tumors, and the safety of the on-target/off-tumor recognition of normal tissues is one of the main reasons. In this mini-review, we characterize some of the mechanisms for antigen loss relapse and new strategies to address this issue. In addition, we discuss some novel CAR designs that are being considered to enhance the safety of CAR-T cell therapy in solid tumors.

New development in CAR-T cell therapy

Directory of Open Access Journals (Sweden)

Zhenguang Wang

2017-02-01

Full Text Available Abstract Chimeric antigen receptor (CAR-engineered T cells (CAR-T cells have yielded unprecedented efficacy in B cell malignancies, most remarkably in anti-CD19 CAR-T cells for B cell acute lymphoblastic leukemia (B-ALL with up to a 90% complete remission rate. However, tumor antigen escape has emerged as a main challenge for the long-term disease control of this promising immunotherapy in B cell malignancies. In addition, this success has encountered significant hurdles in translation to solid tumors, and the safety of the on-target/off-tumor recognition of normal tissues is one of the main reasons. In this mini-review, we characterize some of the mechanisms for antigen loss relapse and new strategies to address this issue. In addition, we discuss some novel CAR designs that are being considered to enhance the safety of CAR-T cell therapy in solid tumors.

Pediatric-specific\tAntimicrobial\tResistance\tPatterns\tof\tUrinary\tTract\tInfections: A\tSingle-Centre\tExperience\tfrom\tTurkey

Directory of Open Access Journals (Sweden)

Yasar Kandur

2016-12-01

Full Text Available Objectives: Antimicrobial resistance of the causative microorganisms of pediatric urinary tract infection (UTI is a growing problem.\tThe\taim\tof\tthis\tstudy\tis\tto\tdetermine\tthe\tchanging\tpattern\tof\tantibiotic\tsusceptibility\tin\tUTIs\tin\tan\toutpatient\tsetting. Methods: We\tretrospectively\treviewed\tthe\tmedical\trecords\tof\tpediatric\tpatients\twith\tUTI\twho\twere\tfollowed-up\tin\tour\tcenter between\tJanuary-2014\tand\tMay-2015. Results: One hundred and seventy-one patients (M/F= 53/118;\tmean age 56 ± 47.2\tmonths with UTI were enrolled\tin this study.\tA\ttotal\tof\t231\turinary\tpathogens\twere\tisolated\tfrom\tUTI\tepisodes.\tThe\tmost\tcommon\tcausative\tagent\twas\tEscherichia\tcoli (E. coli (70.6% followed by Klebsiella spp. (16.5%, Proteus spp. (6.5%. One point eight percent of E. coli isolates were resistant to amikacin, 17.8% to gentamicin, 60.7% to TMP-SMX, 66,9% to ampicillin, 52.1% to cefixime, 46% to ceftriaxone, 54.6%\tto\tcefuroxime\tand\t4.9%\tto\tnitrofurantoin. Conclusions: TMP-SMX and nitrofurantoin are poor empirical choices for pediatric patients due high resistance rates and gastrointestinal side effects, respectively. Second and third -generation cephalosporins (cefixime may not be considered as appropriate\tempiric\tantibiotic\talternatives\tanymore\tgiven\ttheir\thigh\tresistance\trates\tin\tthe\tnext\tfew\tyears.\tPhysicians\twho\twork in\tthe\tprimary\thealth\tcare\tshould\tbe\tencouraged\tfor\tthe\tselection\tof\tmore\tappropriate\tantibiotics.

Psychological issues in cleft lip and cleft palate

OpenAIRE

Sousa Avinash; Devare Shibani; Ghanshani Jyoti

2009-01-01

Vocational and social issues affect rehabilitation and development of patients with cleft lip and cleft palate. However, psychological problems like lowered self esteem and difficulties in social interaction have also been noted in them. Not many pediatric reconstructive surgery teams have a psychiatrist on their panel. It is likely that psychological problems are higher in incidence than literature actually suggests. Hence it is very essential that such cases are identified by the surgical t...

Intellectual Issues in the History of Artificial Intelligence

Science.gov (United States)

1982-10-28

34 tasks, not just because the term conveys the contrast between childish and grown-up pursuits, but also because stacking children’s blocks had become a...34 metaphor - which took the operation of science, with its notion of cooperation.’ publication, experiment, criticism, education , etc, as the appropriate...Freeman, 1973. PAGE 41 Newell, Allen. One final word. In Tuma. D. T. and Reif, F. (Eds.), Problem Solving and Education : Issues in teaching and

Pacific Island Pharmacovigilance

DEFF Research Database (Denmark)

McEwen, John; Vestergaard, Lasse S.; Sanburg, Amanda L C

2016-01-01

Many Pacific Island countries (PICs) are recipients of funding support from the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund). However, most of these countries cannot be expected to meet Global Fund and World Health Organization (WHO) minimum requirements for a functioning...

Primary resistance to osimertinib due to SCLC transformation: Issue of T790M determination on liquid re-biopsy.

Science.gov (United States)

Minari, R; Bordi, P; Del Re, M; Facchinetti, F; Mazzoni, F; Barbieri, F; Camerini, A; Comin, C E; Gnetti, L; Azzoni, C; Nizzoli, R; Bortesi, B; Rofi, E; Petreni, P; Campanini, N; Rossi, G; Danesi, R; Tiseo, M

2018-01-01

EGFR T790M mutation is the most common mechanism of resistance to first-/second-generation EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) and could be overcome by third-generation EGFR-TKIs, such as osimertinib. Liquid biopsy, a non-invasive technique used to test the presence of the resistant mutation, may help avoiding tissue re-biopsy. However, analysing only circulating-free DNA, information about other less frequent and coexisting resistance mechanisms may remain unrevealed. All patients reported in this series participated in the ASTRIS trial, a real world treatment study testing the efficacy of osimertinib (80mg os die) in advanced T790M-positive NSCLC progressed to prior EGFR-TKI. Patients were considered eligible to osimertinib if T790M positive on tissue or plasma samples. In our patients, EGFR molecular testing on blood sample was conducted with digital droplet PCR (ddPCR). We report our experience of five patients treated with osimertinib after T790M detection on liquid biopsy that presented a disease progression at first tumor assessment mediated by SCLC transformation, as evidenced at tissue re-biopsies. All patients showed low ratio T790M/activating mutation in the blood before osimertinib (lower than 0.03). For three patients, EGFR mutational analysis was T790M-negative when re-assessed by using a less sensitive method (therascreen ® ) on the same liquid biopsy sample analysed by ddPCR before osimertinib therapy. Although liquid biopsy is a relevant tool to diagnose T790M presence in NSCLC patients resistant to EGFR-TKI, in case of a low ratio T790M/activating mutation, tissue biopsy should be considered to exclude the presence of SCLC transformation and/or other concomitant resistance mechanisms. Copyright © 2017 Elsevier B.V. All rights reserved.

Combination immunotherapy with prostate GVAX and ipilimumab: safety and toxicity.

Science.gov (United States)

Karan, Dev; Van Veldhuizen, Peter

2012-06-01

Evaluation of: van den Eertwegh AJ, Versluis J, van den Berg HP et al. Combined immunotherapy with granulocyte-macrophage colony-stimulating factor-transduced allogeneic prostate cancer cells and ipilimumab in patients with metastatic castration-resistant prostate cancer: a Phase 1 dose-escalation trial. Lancet Oncol. 13(5), 509 – 517 (2012). A significant interest in the development of therapeutic cancer vaccines over the last decade has led to an improvement in overall survival of cancer patients in several clinical trials. As a result, two active immunotherapy agents, sipuleucel-T and ipilimumab, have been approved by the US FDA for the treatment of prostate cancer and melanoma, respectively. GVAX(®) cellular vaccine (Cell Genesysis, Inc., CA, USA) is another active immunotherapy agent targeting prostate cancer and it has been well studied in various clinical trials. The current publication, by van den Eertwegh et al., demonstrated a combination of two active immunotherapy approaches, using GVAX and ipilimumab for the treatment of metastatic castration-resistant prostate cancer. While GVAX is designed to amplify the antitumor response specific to prostate cancer cells, ipilimumab contributes to T-cell activation. Thus, the authors presented the possibility of augmenting antitumor T-cell activity in two different ways. They successfully demonstrated a tolerable dose and safety profile of ipilimumab in combination with GVAX for patients with metastatic castration-resistant prostate cancer. However, further studies of such immunotherapy combinations and detailed analysis of their immunological effects are needed to observe clinical benefit.

Security Framework for the Web of IoT Platforms

OpenAIRE

Atarah, Ivan Akoribila

2017-01-01

Connected devices of IoT platforms are known to produce, process and exchange vast amounts of data, most of it sensitive or personal, that need to be protected. However, achieving minimal data protection requirements such as confidentiality, integrity, availability and non-repudiation in IoT platforms is a non-trivial issue. For one reason, the trillions of interacting devices provide larger attack surfaces. Secondly, high levels of personal and private data sharing in this ubiquitous and het...

Patient Participation and the Use of Ehealth Tools for Pharmacoviligance

OpenAIRE

Berrewaerts, Jo?lle; Delbecque, Laure; Orban, Pierre; Desseilles, Martin

2016-01-01

In recent years, pharmacovigilance has undergone some major changes. First, the patient’s active role in identifying and describing adverse drug reactions (ADRs) has gained recognition. Second, pharmacovigilance has increasingly incorporated information and communications technology (ICT). Patients can now upload their own reports of ADRs online. Data on intensive medication monitoring are now collected via the Internet and smartphones. Worldwide collection of AEs using smart phones might bec...

The dynamics of abyssal T-phases

Science.gov (United States)

Stephen, Ralph A.; Smith, Deborah K.; Williams, Clare

2002-11-01

The characteristics of earthquakes, as revealed by T-phase observations, have the potential to provide important constraints on physical models of crustal processes under the oceans. Although it has been postulated that some form of scattering at or near the seafloor is necessary to convert the compressional and shear body waves from earthquakes into the low grazing angle paths necessary for propagation in the ocean sound channel, there are T-phase observations that cannot be explained by seafloor scattering alone. Water depth above the epicenter, for example, should have a strong effect on T-phase excitation. We use the time domain finite-difference method combined with ray theory to demonstrate these issues and we compare the theory to a series of events that occurred near the mid-Atlantic Ridge at the Kane Fracture Zone (MARK) in 1999 and 2000. There is evidence in this data set which suggests that topographic steering of T-phase locations occurs. Earthquake energy appears to preferentially enter the sound channel at topographic highs and epicentral locations are biased toward shallow bathymetry.

A human factors experiment on the event-paced control tasks issue

Energy Technology Data Exchange (ETDEWEB)

Lee, Hyun Chul; Park, Jae Chang; Oh, In Seok; Lee, Jung Woon; Lee, Ki Young; Park, Jong Kyun [Korea Atomic Energy Research Institute, Taejeon (Korea)

2000-03-01

KEPRI(Korea Electric Power Research Institute) requires human factors validation tests according to the progress of the KNGR MMI design. This report describes the experimental results of an human factors validation issue, Event-Paced Control Tasks issue. The Event-Paced Control Task issue is to test that the designed MMI shall support operators in performing control tasks in pace with the plant dynamics. Task completion time and successful execution are defined as performance measures on the issue. Through an experiment on the issue with 3 scenarios and 5 subjects, we report that the variation of task completion time between subjects has a narrow band for each scenarios, however two among the total 15 experimental runs result in the failure that subject does not reach to the predefined operational goal. Incorrect operational strategy, insufficient training, and MMI design discrepancies are inferred as the causes of the failures. However these experimental results don't indicate the close of the Event-Paced Control Tasks issue. The validation test results under the experimental environment composed of the partial MMI representations, an unstable simulator, and insufficient subject training, are significant in the limited conditions. Thus, for the purpose of the complete issue close, the validation test on the Event-Paced Control Tasks issue should be repeatedly carried out in pace with the performance improvement of the experimental environment. 13 figs., 4 tabs. (Author)

EDITORIAL: Cluster issue on Heusler compounds and devices Cluster issue on Heusler compounds and devices

Science.gov (United States)

Felser, Claudia; Hillebrands, Burkard

2009-04-01

of the spin-Hall effect, spin-torque investigations and CPP GMR (current perpendicular plane giant magnetoresistance). Schneider et al have studied the Hall effect of laser ablated Co2(MnFe)Si thin films. Recently Inomata's group has reported on a high CPP GMR effect based on CFSA [19]. In this issue a theoretical study by Dai et al reports on the interfaces between CCFA and very thin chromium layers. Here the interface stays half-metallic which is a promising result regarding the realization of potential GMR devices. For spin-torque applications special requirements concerning the materials are necessary. Low damping constants, low magnetic moments and a perpendicular anisotropy are favourable properties. Ferrimagnetic Heusler compounds are candidates for low magnetic moments despite a high spin polarization and a high Curie temperature [20, 21]. Mn3Ga shows additionally a tetragonal distortion, which is favourable for perpendicular anisotropy [21]. The stability of Heusler compounds versus structural distortion is a well known phenomenon in shape memory alloys [22]. We hope this cluster of papers will inspire many researchers in the field of spintronics and motivate some of them to use these advanced materials for new devices. References [1] Heusler F 1903 Verh. Dtsch. Phys. Ges. 12 219 [2] de Groot R A, Müller F M, van Engen P G and Buschow K H J 1983 Phys. Rev. Lett. 50 2024 [3] Kübler J, Williams A R, Sommers C B 1983 Phys. Rev. B 28 1745 [4] Block T, Felser C and Jakob G 2003 J. Solid State Chem. 176 646 [5] Galanakis I, Mavropoulos Ph and Dederichs P H 2006 J. Phys. D: Appl. Phys. 39 765 [6] Kandpal H C, Fecher G H and Felser C 2007 J. Phys. D: Appl. Phys. 40 1507 [7] Wurmehl S, Fecher G H, Kandpal H C, Ksenofontov V, Felser C and Lin H J 2006 Appl. Phys. Lett. 86 032503 [8] Kämmerer S, Thomas A, Hütten A and Reiss G 2004 Appl. Phys. Lett. 85 79 [9] Yamato M, Marukame T, Ishikawa T, Matsuda K, Uemura T and Arita M 2006 J. Phys. D: Appl. Phys. 39 824 [10

Fashioning a New Regime for Agricultural Trade: New Issues and the Global Food Crisis

OpenAIRE

Thomas J. Schoenbaum

2011-01-01

This article examines the impact of issues such as the global food crisis, export controls on agricultural products, and food security on the agricultural trade negotiations currently underway in connection with the Doha Development Agenda convened by the World Trade Organization (WTO) in 2001. These important issues, which were not foreseen when the negotiations began, must now be squarely faced. Many international organizations, such as the United Nations, the International Monetary Fund, t...

SUMMARY REPORT OF THE INTERACTION REGION WORKING GROUP (T1) AT SNOWMASS

Energy Technology Data Exchange (ETDEWEB)

Markiewicz, Thomas W

2002-09-23

The Interaction Region Working Group (T1) at Snowmass 2001 reviewed the issues, designs, and plans of existing and proposed colliders, including hadron colliders, e{sup -} hadron colliders, e{sup +}e{sup -} and {gamma}{gamma} linear colliders, e{sup +}e{sup -} circular colliders, and muon colliders. This document summarizes the IR issues, status, and R&D plans for each project.

Heterosybtypic T-cell immunity to influenza in humans: challenges for universal T-cell influenza vaccines

Directory of Open Access Journals (Sweden)

Saranya eSridhar

2016-05-01

Full Text Available Influenza A virus (IAV remains a significant global health issue causing annual epidemics, pandemics and sporadic human infections with highly pathogenic avian or swine influenza viruses. Current inactivated and live vaccines are the mainstay of the public health response to influenza although vaccine efficacy is lower against antigenically distinct viral strains. The first pandemic of the 21st century underlined the urgent need to develop new vaccines capable of protection against a broad range of influenza strains. Such universal influenza vaccines are based on the idea of heterosubtypic immunity wherein immune responses to epitopes conserved across IAV strains can confer protection against subsequent infection and disease. T-cells recognising conserved antigens are a key contributor to reducing viral load and limiting disease severity during heterosubtypic infection in animal models. Recent studies undertaken during the 2009 H1N1 pandemic provided key insights into the role of cross-reactive T-cells in mediating heterosubtypic protection in humans. This review focuses on human influenza to discuss the epidemiological observations that underpin cross-protective immunity, the role of T-cells as key players in mediating heterosubtypic immunity including recent data from natural history cohort studies and the ongoing clinical development of T-cell inducing universal influenza vaccines. The challenges and knowledge gaps for developing vaccines to generate long-lived protective T-cell responses is discussed.

Status of safety issues at licensed power plants: TMI Action Plan requirements, unresolved safety issues, generic safety issues, other multiplant action issues

International Nuclear Information System (INIS)

1992-12-01

This report is to provide a comprehensive description of the implementation and verification status of Three Mile Island (TMI) Action Plan requirements, safety issues designated as Unresolved Safety Issues (USIs), Generic Safety Issues(GSIs), and other Multiplant Actions (MPAs) that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. An additional purpose of this NUREG report is to serve as a follow-on to NUREG-0933, ''A Prioritization of Generic Safety Issues,'' which tracks safety issues up until requirements are approved for imposition at licensed plants or until the NRC issues a request for action by licensees

Ferrocyanide Safety Program: Data interpretation report for tank 241-T-107 core samples

International Nuclear Information System (INIS)

Sasaki, L.M.; Valenzuela, B.D.

1994-08-01

Between November 1992 and March 1993, three core samples were obtained from tank 241-T-107. Analyses were performed on these core samples to support the Ferrocyanide Safety Program and the Hanford Federal Facility Agreement and Consent Order (Ecology et al. 1994) Milestone M-10-00. This document summarizes and evaluates those analytical results that are pertinent to the Ferrocyanide Safety Issue. This document compares the analytical results with the data requirements for ferrocyanide tanks as documented in Data Requirements of the Ferrocyanide Safety Issue Developed Through the Data Quality Objectives Process (Meacham et al. 1994) and provides an assessment of the safety condition of the tank. Analytes not listed in the Data Quality Objectives (DQO) document (Meacham et al. 1994) or not pertinent to the Ferrocyanide Safety Issue are not discussed in this report. Complete documentation of the analytical results can be found in the data package for the tank 241-T-107 cores (Svancara and Pool 1993). A more complete evaluation of the analytical results and an estimate of the tank inventory will be provided in a forthcoming tank characterization report for tank 241-T-107

CD4 T-Cell Memory Generation and Maintenance

Science.gov (United States)

Gasper, David J.; Tejera, Melba Marie; Suresh, M.

2014-01-01

Immunologic memory is the adaptive immune system's powerful ability to remember a previous antigen encounter and react with accelerated vigor upon antigen re-exposure. It provides durable protection against reinfection with pathogens and is the foundation for vaccine-induced immunity. Unlike the relatively restricted immunologic purview of memory B cells and CD8 T cells, the field of CD4 T-cell memory must account for multiple distinct lineages with diverse effector functions, the issue of lineage commitment and plasticity, and the variable distribution of memory cells within each lineage. Here, we discuss the evidence for lineage-specific CD4 T-cell memory and summarize the known factors contributing to memory-cell generation, plasticity, and long-term maintenance. PMID:24940912

A technical guide to tDCS, and related non-invasive brain stimulation tools

Science.gov (United States)

Woods, AJ; Antal, A; Bikson, M; Boggio, PS; Brunoni, AR; Celnik, P; Cohen, LG; Fregni, F; Herrmann, CS; Kappenman, ES; Knotkova, H; Liebetanz, D; Miniussi, C; Miranda, PC; Paulus, W; Priori, A; Reato, D; Stagg, C; Wenderoth, N; Nitsche, MA

2015-01-01

Transcranial electrical stimulation (tES), including transcranial direct and alternating current stimulation (tDCS, tACS) are non-invasive brain stimulation techniques increasingly used for modulation of central nervous system excitability in humans. Here we address methodological issues required for tES application. This review covers technical aspects of tES, as well as applications like exploration of brain physiology, modelling approaches, tES in cognitive neurosciences, and interventional approaches. It aims to help the reader to appropriately design and conduct studies involving these brain stimulation techniques, understand limitations and avoid shortcomings, which might hamper the scientific rigor and potential applications in the clinical domain. PMID:26652115

Pharmacovigilance of artemether-lumefantrine in pregnant women followed until delivery in Rwanda

OpenAIRE

Rulisa Stephen; Kaligirwa Nadine; Agaba Steven; Karema Corine; Mens Petra F; de Vries Peter J

2012-01-01

Abstract Background The World Health Organization presently recommends Artemisinin-based combination therapy (ACT) as first-line therapy for uncomplicated P. falciparum malaria. Many malaria-endemic countries, including Rwanda, have adopted these treatment guidelines. The Artemisinin derivative Artemether, in combination with lumefantrine, is currently used in Rwanda for malaria during the second and third trimesters of pregnancy. Safety data on the use of ACT in pregnancy are still limited t...

Human centric security and privacy for the IoT using formal techniques

OpenAIRE

Kammueller, Florian

2018-01-01

In this paper, we summarize a new approach to make security and privacy issues in the Internet of Things (IoT) more transparent for vulnerable users. As a pilot project, we investigate monitoring of Alzheimer’s patients for a low-cost early warning system based on bio-markers supported with smart technologies. To provide trustworthy and secure IoT infrastructures, we employ formal methods and techniques that allow specification of IoT scenarios with human actors, refinement and analysis of at...

Oiling and cleanup issues in wetlands, M/T Julie N spill, Portland, Maine

International Nuclear Information System (INIS)

Michel, J.; Lehmann, S.M.; Henry, C.B.Jr.

1998-01-01

The clean up and environmental assessment techniques which were used following the September 1996 oil spill from the M/T Julie N in Portland Harbor, Maine were reviewed and documented. The spill resulted in heavy oiling of wetland. Aerial photography, ground-truth surveys, transects and chemical sampling were conducted to try to assess the impact to wetlands and to decide on appropriate cleanup options. A range of cleanup methods were attempted including low-pressure flushing, shoreline cleaning agents, vegetation cutting, and natural recovery. 9 refs., 3 tabs., 1 fig

Tank characterization report for single-shell tank 241-T-105

International Nuclear Information System (INIS)

Field, J.G.

1998-01-01

A major function of the Tank Waste Remediation System (TWRS) is to characterize waste in support of waste management and disposal activities at the Hanford Site. Analytical data from sampling and analysis and other available information about a tank are compiled and maintained in a tank characterization report (TCR). This report and its appendices serve as the TCR for single-shell tank 241-T-105. The objectives of this report are (1) to use characterization data in response to technical issues associated with tank 241-T-105 waste and (2) to provide a standard characterization of this waste in terms of a best-basis inventory estimate. Section 2.0 summarizes the response to technical issues, Section 3.0 shows the best-basis inventory estimate, Section 4.0 makes recommendations about the safety status of the tank and additional sampling needs. The appendices contain supporting data and information. This report supports the requirements of the Hanford Federal Facility Agreement and Consent Order (Ecology et al. 1997), Milestone M-44-15b, change request M-44-97-03, to ''issue characterization deliverables consistent with the waste information requirements documents developed for 1998''

Tank characterization report for single-shell tank 241-T-112

International Nuclear Information System (INIS)

McCain, D.J.

1998-01-01

A major function of the Tank Waste Remediation System (TWRS) is to characterize waste in support of waste management and disposal activities at the Hanford Site. Analytical data from sampling and analysis and other available information about a tank are compiled and maintained in a tank characterization report (TCR). This report and its appendices serve as the TCR for single-shell tank 241-T-112. The objectives of this report are (1) to use characterization data in response to technical issues associated with tank 241-T-112 waste and (2) to provide a standard characterization of this waste in terms of a best-basis inventory estimate. Section 2.0 summarizes the response to technical issues, Section 3.0 shows the best-basis inventory estimate, Section 4.0 makes recommendations about the safety status of the tank and additional sampling needs. The appendices contain supporting data and information. This report supports the requirements of the Hanford Federal Facility Agreement and Consent Order (Ecology et al. 1997), Milestone M-44-15b, change request M-44-97-03, to ''issue characterization deliverables consistent with the Waste Information Requirements Documents developed for 1998.''

Tank characterization report for single-shell tank 241-T-105

Energy Technology Data Exchange (ETDEWEB)

Field, J.G.

1998-06-18

A major function of the Tank Waste Remediation System (TWRS) is to characterize waste in support of waste management and disposal activities at the Hanford Site. Analytical data from sampling and analysis and other available information about a tank are compiled and maintained in a tank characterization report (TCR). This report and its appendices serve as the TCR for single-shell tank 241-T-105. The objectives of this report are (1) to use characterization data in response to technical issues associated with tank 241-T-105 waste and (2) to provide a standard characterization of this waste in terms of a best-basis inventory estimate. Section 2.0 summarizes the response to technical issues, Section 3.0 shows the best-basis inventory estimate, Section 4.0 makes recommendations about the safety status of the tank and additional sampling needs. The appendices contain supporting data and information. This report supports the requirements of the Hanford Federal Facility Agreement and Consent Order (Ecology et al. 1997), Milestone M-44-15b, change request M-44-97-03, to ``issue characterization deliverables consistent with the waste information requirements documents developed for 1998``.

Feministlik poliitika ja institutsioonikriitika / Angela Dimitrakaki ; tõlkinud Katrin Kivimaa

Index Scriptorium Estoniae

Dimitrakaki, Angela

2011-01-01

Ettekanne sümpoosionil "Common Differences: Issues for Feminist Curating in Post-Socialist Europe" Eesti Kunstiakadeemias 27. mail 2011. Kuratoorse ühisvara idee nõuab kahekordset distantseerumisakti - eemaldumist kapitali huvides töötavatest (kunsti)institutsioonidest ning kunsti ja kunstiajaloo teenistusest

The expanding universe of regulatory T cell subsets in cancer.

Science.gov (United States)

Gajewski, Thomas F

2007-08-01

Evidence has indicated that failed antitumor immunity is dominated by immunosuppressive mechanisms within the tumor microenvironment. In this issue of Immunity, Peng et al. (2007) add to this list by describing tumor-infiltrating gammadelta T cells that have regulatory function.

Current issues in allogeneic islet transplantation.

Science.gov (United States)

Chang, Charles A; Lawrence, Michael C; Naziruddin, Bashoo

2017-10-01

Transplantation of allogenic pancreatic islets is a minimally invasive treatment option to control severe hypoglycemia and dependence on exogenous insulin among type 1 diabetes (T1D) patients. This overview summarizes the current issues and progress in islet transplantation outcomes and research. Several clinical trials from North America and other countries have documented the safety and efficacy of clinical islet transplantation for T1D patients with impaired hypoglycemia awareness. A recently completed phase 3 clinical trial allows centres in the United States to apply for a Food and Drug Administration Biologics License for the procedure. Introduction of anti-inflammatory drugs along with T-cell depleting induction therapy has significantly improved long-term function of transplanted islets. Research into islet biomarkers, immunosuppression, extrahepatic transplant sites and potential alternative beta cell sources is driving further progress. Allogeneic islet transplantation has vastly improved over the past two decades. Success in restoration of glycemic control and hypoglycemic awareness after islet transplantation has been further highlighted by clinical trials. However, lack of effective strategies to maintain long-term islet function and insufficient sources of donor tissue still impose limitations to the widespread use of islet transplantation. In the United States, wide adoption of this technology still awaits regulatory approval and, importantly, a financial mechanism to support the use of this technology.

A knowledge, attitude and practices study of the issues of climate change/variability impacts and public health in Trinidad and Tobago, and St Kitts and Nevis.

Science.gov (United States)

Rawlins, S C; Chen, A; Rawlins, J M; Chadee, D D; Legall, G

2007-03-01

To determine the level of understanding of the issues of climate change (CC)/variability (CV) and public health by populations of St Kitts and Nevis (SKN) and Trinidad and Tobago (T&T) and to find whether respondents would be willing to incorporate these values into strategies for dengue fever (DF) prevention. Using a cluster sampling system, representative samples of the communities of SKN (227) and T&T (650) were surveyed for responses to a questionnaire document with questions on the impact of climate variability on health, the physical environment, respondents' willingness to utilize climate issues to predict and adapt to climate variability for DF prevention. Data were analyzed by Epi Info. Sixty-two per cent SKN and 55% T&T of respondents showed some understanding of the concept of climate change (CC) and distinguished this from climate variability (CV). With regard to causes of CC, 48% SKN and 50% T&T attributed CC to all of green houses gases, holes in the ozone layer burning of vegetation and vehicular exhaust gases. However some 39.3% SKN and 31% (T&T) did not answer this question. In response to ranking issues of life affected by CC/CV in both countries, respondents ranked them: health > water resources > agriculture > biodiversity > coastal degradation. The major health issues identified for SKN and T&T respondents were: food-borne diseases > water-borne diseases > heat stresses; vector-borne diseases were only ranked 4th and 5th for SKN and T&T respondents respectively. There was in both countries a significant proportion of respondents (p attitudes did not always coincide with practices of using ES for DF prevention, in both countries, even with CC/CV tools of prediction being available, it seems that respondents could be persuaded to use such strategies. There is a need for demonstration of the efficacy of CC/CV information and promotion of its usefulness for community involvement in DF and possibly other disease prevention.

ANALISIS FAKTOR-FAKTOR YANG MEMPENGARUHI MOTIVASI MANAJEMEN LABA DI SEPUTAR RIGHT ISSUE

Directory of Open Access Journals (Sweden)

DEWI SAPTANTINAH PUJI ASTUTI

2007-07-01

Full Text Available This research is aimed at analysing factors influencing the motivation of management toconduct earnings management activity around the timing of right issue, and investigatingwhether there are any differences between discretionary accruals before and after the right issue,that is the discretionary accruals tend to be high before the right issue than that of after the rightissue. Some factors influencing the motivation of earnings management used in this research areownership structures, consisted of institutional ownership, managerial ownership, leverage andsize; in this research size was included into controlled variable and earnings management wassubstituted (proxy with discretionary accruals.The sample of this research consists of companies conducting the right issue between theyear of 1998-2001, with 2 years observation period before and after the right issue. Therefore,the period included in this research is 1996-2003. Hypothesis testing is conducted usingregression, while pair t-test is used to investigate the differences of discretionary accruals beforeand after the right issue. The result shows that leverage influences the earnings managementpositively and significantly. It means that the higher the leverage, the more the management ismotivated to conduct earnings management. In addition, the result of the study shows that thereare differences between discretionary accruals before the right issue and that of after the rightissue, i.e. the discretionary accruals before the right issue tends to be higher than that of after.

TwiMed: Twitter and PubMed Comparable Corpus of Drugs, Diseases, Symptoms, and Their Relations.

Science.gov (United States)

Alvaro, Nestor; Miyao, Yusuke; Collier, Nigel

2017-05-03

Work on pharmacovigilance systems using texts from PubMed and Twitter typically target at different elements and use different annotation guidelines resulting in a scenario where there is no comparable set of documents from both Twitter and PubMed annotated in the same manner. This study aimed to provide a comparable corpus of texts from PubMed and Twitter that can be used to study drug reports from these two sources of information, allowing researchers in the area of pharmacovigilance using natural language processing (NLP) to perform experiments to better understand the similarities and differences between drug reports in Twitter and PubMed. We produced a corpus comprising 1000 tweets and 1000 PubMed sentences selected using the same strategy and annotated at entity level by the same experts (pharmacists) using the same set of guidelines. The resulting corpus, annotated by two pharmacists, comprises semantically correct annotations for a set of drugs, diseases, and symptoms. This corpus contains the annotations for 3144 entities, 2749 relations, and 5003 attributes. We present a corpus that is unique in its characteristics as this is the first corpus for pharmacovigilance curated from Twitter messages and PubMed sentences using the same data selection and annotation strategies. We believe this corpus will be of particular interest for researchers willing to compare results from pharmacovigilance systems (eg, classifiers and named entity recognition systems) when using data from Twitter and from PubMed. We hope that given the comprehensive set of drug names and the annotated entities and relations, this corpus becomes a standard resource to compare results from different pharmacovigilance studies in the area of NLP. ©Nestor Alvaro, Yusuke Miyao, Nigel Collier. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 03.05.2017.

26 CFR 1.103(n)-1T - Limitation on aggregrate amount of private activity bonds (temporary).

Science.gov (United States)

2010-04-01

... activity bonds (temporary). 1.103(n)-1T Section 1.103(n)-1T Internal Revenue INTERNAL REVENUE SERVICE... Excluded from Gross Income § 1.103(n)-1T Limitation on aggregrate amount of private activity bonds (temporary). Q-1: What does section 103(n) provide? A-1: Interest on an issue of private activity bonds will...

The Potential Return on Public Investment in Detecting Adverse Drug Effects.

Science.gov (United States)

Huybrechts, Krista F; Desai, Rishi J; Park, Moa; Gagne, Joshua J; Najafzadeh, Mehdi; Avorn, Jerry

2017-06-01

Many countries lack fully functional pharmacovigilance programs, and public budgets allocated to pharmacovigilance in industrialized countries remain low due to resource constraints and competing priorities. Using 3 case examples, we sought to estimate the public health and economic benefits resulting from public investment in active pharmacovigilance programs to detect adverse drug effects. We assessed 3 examples in which early signals of safety hazards were not adequately recognized, resulting in continued exposure of a large number of patients to these drugs when safer and effective alternative treatments were available. The drug examples studied were rofecoxib, cerivastatin, and troglitazone. Using an individual patient simulation model and the health care system perspective, we estimated the potential costs that could have been averted by early systematic detection of safety hazards through the implementation of active surveillance programs. We found that earlier drug withdrawal made possible by active safety surveillance would most likely have resulted in savings in direct medical costs of $773-$884 million for rofecoxib, $3-$10 million for cerivastatin, and $38-$63 million for troglitazone in the United States through the prevention of adverse events. By contrast, the yearly public investment in Food and Drug Administration initiated population-based pharmacovigilance activities in the United States is about $42.5 million at present. These examples illustrate a critical and economically justifiable role for active adverse effect surveillance in protecting the health of the public.

Questions That Won't Go Away in Participatory Research

Science.gov (United States)

Jonathan W. Long; Heidi L. Ballard; Larry A. Fisher; Jill M. Belsky

2016-01-01

Ethical issues are intrinsic to conducting research regarding society and natural resources, but they often become poignant when engaging in Participatory Action Research. We compiled common and persistent challenges into a list of "Questions That Won't Go Away" or "QTWGAs" that are relevant to people interested in conducting participatory...

Computer-assisted analysis of peripheral zone prostate lesions using T2-weighted and dynamic contrast enhanced T1-weighted MRI

Energy Technology Data Exchange (ETDEWEB)

Vos, Pieter C; Hambrock, Thomas; Barenstz, Jelle O; Huisman, Henkjan J [Department of Radiology, Radboud University Medical Centre, Nijmegen, 6525GA (Netherlands)], E-mail: p.vos@rad.umcn.nl

2010-03-21

In this study, computer-assisted analysis of prostate lesions was researched by combining information from two different magnetic resonance (MR) modalities: T2-weighted (T2-w) and dynamic contrast-enhanced (DCE) T1-w images. Two issues arise when incorporating T2-w images in a computer-aided diagnosis (CADx) system: T2-w values are position as well as sequence dependent and images can be misaligned due to patient movement during the acquisition. A method was developed that computes T2 estimates from a T2-w and proton density value and a known sequence model. A mutual information registration strategy was implemented to correct for patient movement. Global motion is modelled by an affine transformation, while local motion is described by a volume preserving non-rigid deformation based on B-splines. The additional value to the discriminating performance of a DCE T1-w-based CADx system was evaluated using bootstrapped ROC analysis. T2 estimates were successfully computed in 29 patients. T2 values were extracted and added to the CADx system from 39 malignant, 19 benign and 29 normal annotated regions. T2 values alone achieved a diagnostic accuracy of 0.85 (0.77-0.92) and showed a significantly improved discriminating performance of 0.89 (0.81-0.95), when combined with DCE T1-w features. In conclusion, the study demonstrated a simple T2 estimation method that has a diagnostic performance such that it complements a DCE T1-w-based CADx system in discriminating malignant lesions from normal and benign regions. Additionally, the T2 estimate is beneficial to visual inspection due to the removed coil profile and fixed window and level settings.

RETRACTED: Relationship between the ACE I/D gene polymorphism and T1DN susceptibility/risk of T1DM developing into T1DN in the Caucasian population.

Science.gov (United States)

Zhou, Tian-Biao; Guo, Xue-Feng; Jiang, Zongpei; Li, Hong-Yan

2015-12-01

The following article has been included in a multiple retraction: Tian-Biao Zhou, Xue-Feng Guo, Zongpei Jiang, and Hong-Yan Li Relationship between the ACE I/D gene polymorphism and T1DN susceptibility/risk of T1DM developing into T1DN in the Caucasian population Journal of Renin-Angiotensin-Aldosterone System 1470320314563425, first published on February 1, 2015 doi: 10.1177/1470320314563425 This article has been retracted at the request of the Editors and the Publisher. After conducting a thorough investigation, SAGE found that the submitting authors of a number of papers published in the Journal of the Renin-Angiotensin Aldosterone System ( JRAAS) (listed below) had supplied fabricated contact details for their nominated reviewers. The Editors accepted these papers based on the reports supplied by the individuals using these fake reviewer email accounts. After concluding that the peer review process was therefore seriously compromised, SAGE and the journal Editors have decided to retract all affected articles. Online First articles (these articles will not be published in an issue) Wenzhuang Tang, Tian-Biao Zhou, and Zongpei Jiang Association of the angiotensinogen M235T gene polymorphism with risk of diabetes mellitus developing into diabetic nephropathy Journal of Renin-Angiotensin-Aldosterone System 1470320314563426, first published on December 18, 2014 doi: 10.1177/1470320314563426 Tian-Biao Zhou, Hong-Yan Li, Zong-Pei Jiang, Jia-Fan Zhou, Miao-Fang Huang, and Zhi-Yang Zhou Role of renin-angiotensin-aldosterone system inhibitors in radiation nephropathy Journal of Renin-Angiotensin-Aldosterone System 1470320314563424, first published on December 18, 2014 doi: 10.1177/1470320314563424 Weiqiang Zhong, Zongpei Jiang, and Tian-Biao Zhou Association between the ACE I/D gene polymorphism and T2DN susceptibility: The risk of T2DM developing into T2DN in the Asian population Journal of Renin-Angiotensin-Aldosterone System 1470320314566019, first published on January

Using Transcranial Direct Current Stimulation (tDCS to study and treat aphasia

Directory of Open Access Journals (Sweden)

Nazbanou Nozari

2014-04-01

- What are the challenges of using tDCS for hypothesis testing and how can I reduce the risk of misinterpreting my results? In summary, the symposium is designed to (a promote the theoretical understanding of the basic science of tDCS, and (b to tackle several pragmatic issues when designing tDCS studies, with the ultimate goal of cultivating higher standards for using a potentially invaluable technique for both clinical and research purposes. Given the growing interest in the aphasia community for using tDCS and the sophistication of the audience, we believe that the Academy’s annual meeting is the ideal venue for this symposium.

Operational test report for 2706-T complex liquid transfer system

International Nuclear Information System (INIS)

BENZEL, H.R.

1999-01-01

This document is the Operational Test Report (OTR). It enters the Record Copy of the W-259 Operational Test Procedure (HNF-3610) into the document retrieval system. Additionally, the OTR summarizes significant issues associated with testing the 2706-T waste liquid transfer and storage system

Role of T cell receptor affinity in the efficacy and specificity of adoptive T cell therapies

Directory of Open Access Journals (Sweden)

Jennifer D. Stone

2013-08-01

Full Text Available Over the last several years, there has been considerable progress in the treatment of cancer using gene modified adoptive T cell therapies. Two approaches have been used, one involving the introduction of a conventional alpha-beta T cell receptor (TCR against a pepMHC cancer antigen, and the second involving introduction of a chimeric antigen receptor (CAR consisting of a single-chain antibody as an Fv fragment (scFv linked to transmembrane and signaling domains. In this review, we focus on one aspect of TCR-mediated adoptive T cell therapies, the impact of the affinity of the alpha-beta TCR for the pepMHC cancer antigen on both efficacy and specificity. We discuss the advantages of higher affinity TCRs in mediating potent activity of CD4 T cells. This is balanced with the potential disadvantage of higher affinity TCRs in mediating greater self-reactivity against a wider range of structurally similar antigenic peptides, especially in synergy with the CD8 co-receptor. Both TCR affinity and target selection will influence potential safety issues. We suggest pre-clinical strategies that might be used to examine each TCR for possible on-target and off-target side effects due to self-reactivities, and to adjust TCR affinities accordingly.

Global Issues

Energy Technology Data Exchange (ETDEWEB)

Seitz, J.L.

2001-10-15

Global Issues is an introduction to the nature and background of some of the central issues - economic, social, political, environmental - of modern times. This new edition of this text has been fully updated throughout and features expanded sections on issues such as global warming, biotechnology, and energy. Fully updated throughout and features expanded sections on issues such as global warming, biotechnology, and energy. An introduction to the nature and background of some of the central issues - economic, social, political, environmental - of modern times. Covers a range of perspectives on a variety of societies, developed and developing. Extensively illustrated with diagrams and photographs, contains guides to further reading, media, and internet resources, and includes suggestions for discussion and studying the material. (author)

Traffic- Croatia Facing the Global Issues

Directory of Open Access Journals (Sweden)

Ivan Mahalec

2012-10-01

Full Text Available Traffic today is an indispensable part of our lives and oneof the basic preconditions of what is called social progress. Likeblood in our body it circulates across the whole globe and allowsfor the necessary flow of people and materials. This workconsiders the impact of traffic on the lives of people and on theenvironment, analyses the available energy sources and vehiclepropulsion systems and illustrates global climatic issues. Thepaper presents the methodology created by EU for monitoringof harmful emissions at the national/eve! and gives data on differencesin emissions of individualtransp01t modes. The trafficcondition in the Republic of Croatia is analysed and a thesis isgiven regarding possible solution of the stated problems.

Do we have to Include HCI Issues in Clinical Trials of Medical Devices?

DEFF Research Database (Denmark)

Nielsen, Lene; Christensen, Lars Rune; Sabers, Anne

2017-01-01

Digital devices play an important role in medical treatment and will in the future play a larger role in connection to cures of health-related issues. Traditionally medicine has been tested by clinical double blind, randomized trials to document the efficacy and safety profile. When it comes to t...

The transportation issue management system: A tool for issue resolution

International Nuclear Information System (INIS)

Branch, K.M.; Boryczka, M.K.

1987-01-01

During the last decade, issue management programs have been developed and used by a number of large corporations in the United States. These systems have generally been designed to help senior program managers identify issues, develop strategic plans, and resolve issues. These systems involve scanning and abstracting literature to create a database that is then used for 1) issue identification, 2) issue analysis, 3) priority assessment, 4) development of corporate position/strategic options, and 5) action planning and implementation. Most of the existing systems rely on staff to identify trends in the computerized output, analyze the importance of the issue to the company, and assist in developing corporate responses. The Department of Energy has recently developed an issue management system for the Office of Civilian Radioactive Waste Management's (OCRWM) transportation program. This system is designed to help DOE identify institutional issues related to radioactive waste transportation, analyze the issues, and resolve them in a manner that is responsive to interested parties. The system will contain pertinent information from DOE technical reports, other federal documents, correspondence, professional journals, popular literature, newsclips, legislation and testimony. The program is designed around a number of institutional issues including: prenotification, physical protection procedures; highway, rail, and barge routing; inspections and enforcement of shipments; emergency response; liability, cask design and testing; overweight trucks; rail service; modal mix; infrastructure improvements; training standards, and operational procedures

Education and training issues in individual monitoring of ionising radiation

International Nuclear Information System (INIS)

Dimitriou, P.; Kamenopoulou, V.

2011-01-01

The present article deals with the education and training (E and T) issues of individual monitoring (IM) of ionising radiation, based on the requirements provided by the Basic Safety Standards EURATOM Directive and the European Commission Technical Recommendations for IM of external radiation. The structure and the objectives of E and T programmes addressed to the staff of dosimetry services, in order to allow the recognition and ensure the continuity of expertise are discussed. The necessity for the establishment of a national strategy for building competence in IM through information, education, training and retraining programmes, addressed to the individually monitored personnel is underlined. The train the trainers' concept is recognised as being an important tool for optimising resources and transferring the skills necessary for building competence. The conditions under which an efficient train the trainers' approach can be established are discussed. Examples of curricula concerning the key persons involved in the provision of E and T in occupational radiation protection are also given. (authors)

Status of safety issues at licensed power plants: TMI Action Plan requirements; unresolved safety issues; generic safety issues; other multiplant action issues

International Nuclear Information System (INIS)

1993-12-01

As part of ongoing US Nuclear Regulatory Commission (NRC) efforts to ensure the quality and accountability of safety issue information, the NRC established a program for publishing an annual report on the status of licensee implementation and NRC verification of safety issues in major NRC requirements areas. This information was initially compiled and reported in three NUREG-series volumes. Volume 1, published in March 1991, addressed the status of Three Mile Island (TMI) Action Plan Requirements. Volume 2, published in May 1991, addressed the status of unresolved safety issues (USIs). Volume 3, published in June 1991, addressed the implementation and verification status of generic safety issues (GSIs). The first annual supplement, which combined these volumes into a single report and presented updated information as of September 30, 1991, was published in December 1991. The second annual supplement, which provided updated information as of September 30, 1992, was published in December 1992. Supplement 2 also provided the status of licensee implementation and NRC verification of other multiplant action (MPA) issues not related to TMI Action Plan requirements, USIs, or GSIs. This third annual NUREG report, Supplement 3, presents updated information as of September 30, 1993. This report gives a comprehensive description of the implementation and verification status of TMI Action Plan requirements, safety issues designated as USIs, GSIs, and other MPAs that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. Additionally, this report serves as a follow-on to NUREG-0933, ''A Prioritization of Generic Safety Issues,'' which tracks safety issues until requirements are approved for imposition at licensed plants or until the NRC issues a request for action by licensees

Invariant natural killer T cells trigger adaptive lymphocytes to churn up bile.

Science.gov (United States)

Joyce, Sebastian; Van Kaer, Luc

2008-05-15

How innate immune response causes autoimmunity has remained an enigma. In this issue of Cell Host & Microbe, Mattner et al. demonstrate that invariant natural killer T cells activated by the mucosal commensal Novosphingobium aromaticivorans precipitate chronic T cell-mediated autoimmunity against small bile ducts that mirrors human primary biliary cirrhosis. These findings provide a mechanistic understanding of the role of innate immunity toward a microbe in the development of autoimmunity.

High-Performance Signal Detection for Adverse Drug Events using MapReduce Paradigm.

Science.gov (United States)

Fan, Kai; Sun, Xingzhi; Tao, Ying; Xu, Linhao; Wang, Chen; Mao, Xianling; Peng, Bo; Pan, Yue

2010-11-13

Post-marketing pharmacovigilance is important for public health, as many Adverse Drug Events (ADEs) are unknown when those drugs were approved for marketing. However, due to the large number of reported drugs and drug combinations, detecting ADE signals by mining these reports is becoming a challenging task in terms of computational complexity. Recently, a parallel programming model, MapReduce has been introduced by Google to support large-scale data intensive applications. In this study, we proposed a MapReduce-based algorithm, for common ADE detection approach, Proportional Reporting Ratio (PRR), and tested it in mining spontaneous ADE reports from FDA. The purpose is to investigate the possibility of using MapReduce principle to speed up biomedical data mining tasks using this pharmacovigilance case as one specific example. The results demonstrated that MapReduce programming model could improve the performance of common signal detection algorithm for pharmacovigilance in a distributed computation environment at approximately liner speedup rates.

Patient Participation and the Use of Ehealth Tools for Pharmacoviligance

Science.gov (United States)

Berrewaerts, Joëlle; Delbecque, Laure; Orban, Pierre; Desseilles, Martin

2016-01-01

In recent years, pharmacovigilance has undergone some major changes. First, the patient’s active role in identifying and describing adverse drug reactions (ADRs) has gained recognition. Second, pharmacovigilance has increasingly incorporated information and communications technology (ICT). Patients can now upload their own reports of ADRs online. Data on intensive medication monitoring are now collected via the Internet and smartphones. Worldwide collection of AEs using smart phones might become the leading technique in Low and Middle Income Countries where broad mobile phone service can be managed cheaper than Internet communication. At the same time, researchers are exploring the potential for data sharing via online forums and Internet search engines. In particular we synthetize the Pros and cons of the various methods for gathering pharmacovigilance data (i.e., Web-based spontaneous reporting of adverse drug reactions; Intensive drug monitoring studies; Analysis of online forum postings; Use of mobile phone systems to monitor drug effects). This article describes these advances and highlights their respective contributions. PMID:27148052

How to improve communication for the safe use of medicines?: Discussions on social marketing and patient-tailored approaches at the annual meetings of the WHO Programme for International Drug Monitoring.

Science.gov (United States)

Bahri, Priya; Harrison-Woolrych, Mira

2012-12-01

Over the past decade, the annual meetings of national centres participating in the WHO Programme for International Drug Monitoring have increasingly included discussions on how to improve communication between national pharmacovigilance centres, patients, healthcare professionals, policy makers and the general public, with the aim of promoting the safe use of medicines. At the most recent meetings, working groups were dedicated to discuss possible applications and implementation of social marketing and patient-tailored approaches. This article provides the history and a summary of the recent discussions and recommendations to support progress in this respect at national and global level. Recommendations are made to investigate and pilot these approaches in small-scale projects at national pharmacovigilance centres. Applying elements from the social marketing and patient-tailored approaches to support behaviours of safe medicines use in patients and healthcare professionals should give the pharmacovigilance community new tools to achieve their goal to minimize risks with medicines and improve patient safety.

Patient Participation and the Use of Ehealth Tools for Pharmacoviligance.

Science.gov (United States)

Berrewaerts, Joëlle; Delbecque, Laure; Orban, Pierre; Desseilles, Martin

2016-01-01

In recent years, pharmacovigilance has undergone some major changes. First, the patient's active role in identifying and describing adverse drug reactions (ADRs) has gained recognition. Second, pharmacovigilance has increasingly incorporated information and communications technology (ICT). Patients can now upload their own reports of ADRs online. Data on intensive medication monitoring are now collected via the Internet and smartphones. Worldwide collection of AEs using smart phones might become the leading technique in Low and Middle Income Countries where broad mobile phone service can be managed cheaper than Internet communication. At the same time, researchers are exploring the potential for data sharing via online forums and Internet search engines. In particular we synthetize the Pros and cons of the various methods for gathering pharmacovigilance data (i.e., Web-based spontaneous reporting of adverse drug reactions; Intensive drug monitoring studies; Analysis of online forum postings; Use of mobile phone systems to monitor drug effects). This article describes these advances and highlights their respective contributions.

Patient participation and the use of ehealth tools for pharmacoviligance

Directory of Open Access Journals (Sweden)

Joelle eBerrewaerts

2016-04-01

Full Text Available In recent years, pharmacovigilance has undergone some major changes. First, the patient’s active role in identifying and describing adverse drug reactions (ADRs has gained recognition. Second, pharmacovigilance has increasingly incorporated information and communications technology (ICT. Patients can now upload their own reports of ADRs online. Data on intensive medication monitoring are now collected via the Internet and smartphones. Worldwide collection of AEs using smart phones might become the leading technique in Low and Middle Income Countries where broad mobile phone service can be managed cheaper than Internet communication. At the same time, researchers are exploring the potential for data sharing via online forums and Internet search engines. In particular we synthetize the Pros and cons of the various methods for gathering pharmacovigilance data (i.e. Web-based spontaneous reporting of adverse drug reactions; Intensive drug monitoring studies; Analysis of online forum postings; Use of mobile phone systems to monitor drug effects. This article describes these advances and highlights their respective contributions.

RETRACTED: Association between the ACE I/D gene polymorphism and T2DN susceptibility: The risk of T2DM developing into T2DN in the Asian population.

Science.gov (United States)

Zhong, Weiqiang; Jiang, Zongpei; Zhou, Tian-Biao

2015-12-01

This article has been included in a multiple retraction: Weiqiang Zhong, Zongpei Jiang, and Tian-Biao Zhou Association between the ACE I/D gene polymorphism and T2DN susceptibility: The risk of T2DM developing into T2DN in the Asian population Journal of Renin-Angiotensin-Aldosterone System 1470320314566019, first published on January 26, 2015 doi: 10.1177/1470320314566019 This article has been retracted at the request of the Editors and the Publisher. After conducting a thorough investigation, SAGE found that the submitting authors of a number of papers published in the Journal of the Renin-Angiotensin Aldosterone System ( JRAAS) (listed below) had supplied fabricated contact details for their nominated reviewers. The Editors accepted these papers based on the reports supplied by the individuals using these fake reviewer email accounts. After concluding that the peer review process was therefore seriously compromised, SAGE and the journal Editors have decided to retract all affected articles. Online First articles (these articles will not be published in an issue) Wenzhuang Tang, Tian-Biao Zhou, and Zongpei Jiang Association of the angiotensinogen M235T gene polymorphism with risk of diabetes mellitus developing into diabetic nephropathy Journal of Renin-Angiotensin-Aldosterone System 1470320314563426, first published on December 18, 2014 doi: 10.1177/1470320314563426 Tian-Biao Zhou, Hong-Yan Li, Zong-Pei Jiang, Jia-Fan Zhou, Miao-Fang Huang, and Zhi-Yang Zhou Role of renin-angiotensin-aldosterone system inhibitors in radiation nephropathy Journal of Renin-Angiotensin-Aldosterone System 1470320314563424, first published on December 18, 2014 doi: 10.1177/1470320314563424 Weiqiang Zhong, Zongpei Jiang, and Tian-Biao Zhou Association between the ACE I/D gene polymorphism and T2DN susceptibility: The risk of T2DM developing into T2DN in the Asian population Journal of Renin-Angiotensin-Aldosterone System 1470320314566019, first published on January 26, 2015 doi: 10

IoT Privacy and Security Challenges for Smart Home Environments

Directory of Open Access Journals (Sweden)

Huichen Lin

2016-07-01

Full Text Available Often the Internet of Things (IoT is considered as a single problem domain, with proposed solutions intended to be applied across a wide range of applications. However, the privacy and security needs of critical engineering infrastructure or sensitive commercial operations are very different to the needs of a domestic Smart Home environment. Additionally, the financial and human resources available to implement security and privacy vary greatly between application domains. In domestic environments, human issues may be as important as technical issues. After surveying existing solutions for enhancing IoT security, the paper identifies key future requirements for trusted Smart Home systems. A gateway architecture is selected as the most appropriate for resource-constrained devices, and for high system availability. Two key technologies to assist system auto-management are identified. Firstly, support for system auto-configuration will enhance system security. Secondly, the automatic update of system software and firmware is needed to maintain ongoing secure system operation.

Tractable policy management framework for IoT

Science.gov (United States)

Goynugur, Emre; de Mel, Geeth; Sensoy, Murat; Calo, Seraphin

2017-05-01

Due to the advancement in the technology, hype of connected devices (hence forth referred to as IoT) in support of automating the functionality of many domains, be it intelligent manufacturing or smart homes, have become a reality. However, with the proliferation of such connected and interconnected devices, efficiently and effectively managing networks manually becomes an impractical, if not an impossible task. This is because devices have their own obligations and prohibitions in context, and humans are not equip to maintain a bird's-eye-view of the state. Traditionally, policies are used to address the issue, but in the IoT arena, one requires a policy framework in which the language can provide sufficient amount of expressiveness along with efficient reasoning procedures to automate the management. In this work we present our initial work into creating a scalable knowledge-based policy framework for IoT and demonstrate its applicability through a smart home application.

NOVEL CONTEXT-AWARE CLUSTERING WITH HIERARCHICAL ADDRESSING (CCHA) FOR THE INTERNET OF THINGS (IoT)

DEFF Research Database (Denmark)

Mahalle, Parikshit N.; Prasad, Neeli R.; Prasad, Ramjee

2013-01-01

As computing technology becomes more tightly coupled into dynamic and mobile world of the Internet of Things (IoT), security mechanism becomes more stringent, less flexible and intrusive. Scalability issue in the IoT makes Identity Management (IdM) of ubiquitous things more challenging. Forming ad......-hoc network, interaction between these nomadic devices to provide seamless service extend the need of new identi-ties to the things, addressing and IdM in the IoT. New identities and identifier format to alleviate the perfor-mance issue is introduced in this paper. This paper pre-sents novel Context......-aware Clustering with Hierarchical Addressing (CCHA) scheme for the things with new identifier format. Simulation results shows that CCHA achieves better performance with less energy expendi-ture, less end-to-end delay and more throughput. Results also show that CCHA significantly reduces the failure probability...

Current issues relating to psychosocial job strain and cardiovascular disease research.

Science.gov (United States)

Theorell, T; Karasek, R A

1996-01-01

The authors comment on recent reviews of cardiovascular job strain research by P. L. Schnall and P. A. Landsbergis (1994), and by T. S. Kristensen (1995), which conclude that job strain as defined by the demand-control model (the combination of contributions of low job decision latitudes and high psychological job demands) is confirmed as a risk factor for cardiovascular mortality in a large majority of studies. Lack of social support at work appears to further increase risk. Several still-unresolved research questions are examined in light of recent studies: (a) methodological issues related to use of occupational aggregate estimations and occupational career aggregate assessments, use of standard scales for job analysis and recall bias issues in self-reporting; (b) confounding factors and differential strengths of association by subgroups in job strain-cardiovascular disease analyses with respect to social class, gender, and working hours; and (c) review of results of monitoring job strain-blood pressure associations and associated methodological issues.

A genomically modified Escherichia coli strain carrying an orthogonal E. coli histidyl-tRNA synthetase•tRNAHis pair.

Science.gov (United States)

Englert, Markus; Vargas-Rodriguez, Oscar; Reynolds, Noah M; Wang, Yane-Shih; Söll, Dieter; Umehara, Takuya

2017-11-01

Development of new aminoacyl-tRNA synthetase (aaRS)•tRNA pairs is central for incorporation of novel non-canonical amino acids (ncAAs) into proteins via genetic code expansion (GCE). The Escherichia coli and Caulobacter crescentus histidyl-tRNA synthetases (HisRS) evolved divergent mechanisms of tRNA His recognition that prevent their cross-reactivity. Although the E. coli HisRS•tRNA His pair is a good candidate for GCE, its use in C. crescentus is limited by the lack of established genetic selection methods and by the low transformation efficiency of C. crescentus. E. coli was genetically engineered to use a C. crescentus HisRS•tRNA His pair. Super-folder green fluorescent protein (sfGFP) and chloramphenicol acetyltransferase (CAT) were used as reporters for read-through assays. A library of 313 ncAAs coupled with the sfGFP reporter system was employed to investigate the specificity of E. coli HisRS in vivo. A genomically modified E. coli strain (named MEOV1) was created. MEVO1 requires an active C. crescentus HisRS•tRNA His pair for growth, and displays a similar doubling time as the parental E. coli strain. sfGFP- and CAT-based assays showed that the E. coli HisRS•tRNA His pair is orthogonal in MEOV1 cells. A mutation in the anticodon loop of E. coli tRNA His CUA elevated its suppression efficiency by 2-fold. The C. crescentus HisRS•tRNA His pair functionally complements an E. coli ΔhisS strain. The E. coli HisRS•tRNA His is orthogonal in MEOV1 cells. E. coli tRNA His CUA is an efficient amber suppressor in MEOV1. We developed a platform that allows protein engineering of E. coli HisRS that should facilitate GCE in E. coli. This article is part of a Special Issue entitled "Biochemistry of Synthetic Biology - Recent Developments" Guest Editor: Dr. Ilka Heinemann and Dr. Patrick O'Donoghue. Copyright © 2017 Elsevier B.V. All rights reserved.

Transcranial direct current stimulation (tDCS) to improve naming ability in post-stroke aphasia: A critical review.

Science.gov (United States)

ALHarbi, Mohammed F; Armijo-Olivo, Susan; Kim, Esther S

2017-08-14

Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation tool that can be used to influence cortical brain activity to induce measurable behavioral changes. Although there is growing evidence that tDCS combined with behavioural language therapy could boost language recovery in patients with post-stroke aphasia, there is great variability in patient characteristics, treatment protocols, and outcome measures in these studies that poses challenges for analyzing the evidence. The purpose of this study is to critically analyze the methodological rigor of the evidence regarding the use of tDCS for post-stroke anomia. This critical review was conducted by searching four databases (MEDLINE, EMBase, PsycINFO, and CINAHL). Nineteen studies fully met the inclusion criteria. Three critical appraisal tools and Robey and Schultz's (1998) five- phase model for conducting clinical outcome research were adopted to evaluate and analyze the current level of evidence. Methodological issues of the studies were also identified. The current level of evidence for using tDCS for anomia is at the pre-efficacy level with emerging evidence at the efficacy level. Lack of proper evaluation of carry-over effects in cross-over studies, lack of or unclear randomization, allocation concealment, and incomplete data handling were the main methodological issues that could threaten the validity of the tDCS for anomia studies. Several methodological issues have been identified in pre-efficacy studies that pose challenges in determining whether tDCS is a beneficial adjunct to behavioral aphasia therapy. Future studies need to improve the quality of the methods used to investigate the effect of tDCS for anomia. Copyright © 2017 Elsevier B.V. All rights reserved.

Technical issues of fabrication technologies of reduced activation ferritic/martensitic steels

International Nuclear Information System (INIS)

Tanigawa, Hiroyasu; Sakasegawa, Hideo; Hirose, Takanori

2013-01-01

Highlights: • The key technical issues of RAFM steel fabrication are the control of Ta, and deoxidation of the steel with a limited amount of Al addition. • Addition of Ta with poor deoxidation might results in the agglomeration of inclusions at 1/2t position. • ESR was proved to be effective removing Ta oxide inclusions and avoiding agglomeration of inclusions at 1/2t position, and achieving low oxygen concentration. -- Abstract: The key issue for DEMO application is that Reduced activation ferritic/martensitic (RAFM) steels fabrication technologies has to be highly assured, especially with respect to high availability, reliability and reduced activation capability on the DEMO level fabrication, which requires not a few tons but thousand tons RAFM fabrication. One of the key technical issues of RAFM fabrication is the control of Ta, and deoxidation of the steel with a limited amount of Al addition. The series of F82H (Fe–8Cr–2W–V, Ta) melting revealed that Ta have tendency to form oxide on melting process, and this will have large impact on reliability of the steels. Al is also the key elements, as it is commonly used for deoxidation of steels, and achieving lower oxygen level is essential to obtain good mechanical properties, but the maximum concentration of Al is limited in view of reduced activation capability. These tendency and limitation resulted in the Ta oxide agglomeration in the middle of plate, but the remelting process, ESR (electro slag remelting), was found to be successful on removing those Ta oxides

Transcranial direct current stimulation (tDCS in behavioral and food addiction: A systematic review of efficacy, technical and methodological issues

Directory of Open Access Journals (Sweden)

Anne eSauvaget

2015-10-01

Full Text Available Objectives.Behavioral addictions (BA are complex disorders for which pharmacological and psychotherapeutic treatments have shown their limits. Non-invasive brain stimulation, among which transcranial direct current stimulation (tDCS, has opened up new perspectives in addiction treatment. The purpose of this work is to conduct a critical and systematic review of tDCS efficacy, and of technical and methodological considerations in the field of BA.Methods.A bibliographic search has been conducted on the Medline and ScienceDirect databases until December 2014, based on the following selection criteria: clinical studies on tDCS and BA (namely eating disorders, compulsive buying, Internet addiction, pathological gambling, sexual addiction, sports addiction, video games addiction. Study selection, data analysis and reporting were conducted according to the PRISMA guidelines.Results.Out of 402 potential articles, seven studies were selected. So far focusing essentially on abnormal eating, these studies suggest that tDCS (right prefrontal anode / left prefrontal cathode reduces food craving induced by visual stimuli.ConclusionsDespite methodological and technical differences between studies, the results are promising. So far, only few studies of tDCS in BA have been conducted. New research is recommended on the use of tDCS in BA, other than eating disorders.

An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy.

Science.gov (United States)

Richardson, Jonathan Luke; Stephens, Sally; Thomas, Simon Hugh Lynton; Jamry-Dziurla, Anna; de Jong-van den Berg, Lolkje; Zetstra-van der Woude, Priscilla; Laursen, Maja; Hliva, Valerie; Mt-Isa, Shahrul; Bourke, Alison; Dreyer, Nancy A; Blackburn, Stella Cf

2016-01-01

Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized study sample can be recruited. To compare the ability and cost-effectiveness of several direct-to-participant advertising methods for the recruitment of pregnant participants into a study of self-reported gestational exposures and pregnancy outcomes. The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) pregnancy study is a non-interventional, prospective pilot study of self-reported medication use and obstetric outcomes provided by a cohort of pregnant women that was conducted in Denmark, the Netherlands, Poland, and the United Kingdom. Direct-to-participant advertisements were provided via websites, emails, leaflets, television, and social media platforms. Over a 70-week recruitment period direct-to-participant advertisements engaged 43,234 individuals with the study website or telephone system; 4.78% (2065/43,234) of which were successfully enrolled and provided study data. Of these 90.4% (1867/2065) were recruited via paid advertising methods, 23.0% (475/2065) of whom were in the first trimester of pregnancy. The overall costs per active recruited participant were lowest for email (€23.24) and website (€24.41) advertisements and highest for leaflet (€83.14) and television (€100.89). Website adverts were substantially superior in their ability to recruit participants during their first trimester of pregnancy (317/668, 47.5%) in comparison with other advertising methods (Padvertisement methods used and in their ability to recruit participants in early pregnancy. Recruitment of a pregnant cohort using direct-to-participant advertisement methods is feasible, but the total costs incurred are not insubstantial. Future research is

Special issue on cluster algebras in mathematical physics

Science.gov (United States)

Di Francesco, Philippe; Gekhtman, Michael; Kuniba, Atsuo; Yamazaki, Masahito

2014-02-01

This is a call for contributions to a special issue of Journal of Physics A: Mathematical and Theoretical dedicated to cluster algebras in mathematical physics. Over the ten years since their introduction by Fomin and Zelevinsky, the theory of cluster algebras has witnessed a spectacular growth, first and foremost due to the many links that have been discovered with a wide range of subjects in mathematics and, increasingly, theoretical and mathematical physics. The main motivation of this special issue is to gather together reviews, recent developments and open problems, mainly from a mathematical physics viewpoint, into a single comprehensive issue. We expect that such a special issue will become a valuable reference for the broad scientific community working in mathematical and theoretical physics. The issue will consist of invited review articles and contributed papers containing new results on the interplays of cluster algebras with mathematical physics. Editorial policy The Guest Editors for this issue are Philippe Di Francesco, Michael Gekhtman, Atsuo Kuniba and Masahito Yamazaki. The areas and topics for this issue include, but are not limited to: discrete integrable systems arising from cluster mutations cluster structure on Poisson varieties cluster algebras and soliton interactions cluster positivity conjecture Y-systems in the thermodynamic Bethe ansatz and Zamolodchikov's periodicity conjecture T-system of transfer matrices of integrable lattice models dilogarithm identities in conformal field theory wall crossing in 4d N = 2 supersymmetric gauge theories 4d N = 1 quiver gauge theories described by networks scattering amplitudes of 4d N = 4 theories 3d N = 2 gauge theories described by flat connections on 3-manifolds integrability of dimer/Ising models on graphs. All contributions will be refereed and processed according to the usual procedure of the journal. Guidelines for preparation of contributions The deadline for contributed papers is 31 March

Status of safety issues at licensed power plants: TMI Action Plan requirements, unresolved safety issues, generic safety issues, other multiplant action issues. Supplement 4

International Nuclear Information System (INIS)

1994-12-01

As part of ongoing US Nuclear Regulatory Commission (NRC) efforts to ensure the quality and accountability of safety issue information, the NRC established a program for publishing an annual report on the status of licensee implementation and NRC verification of safety issues in major NRC requirements areas. This information was initially compiled and reported in three NUREG-series volumes. Volume 1, published in March 1991, addressed the status of Three Mile Island (TMI) Action Plan Requirements. Volume 2, published in May 1991, addressed the status of unresolved safety issues (USIs). Volume 3, published in June 1991, addressed the implementation and verification status of generic safety issues (GSIs). The first annual supplement, which combined these volumes into a single report and presented updated information as of September 30, 1991, was published in December 1991. The second annual supplement, which provided updated information as of September 30, 1992, was published in December 1992. Supplement 2 also provided the status of licensee implementation and NRC verification of other multiplant action (MPA) issues not related to TMI Action Plan requirements, USIs, or GSIs. Supplement 3 gives status as of September 30, 1993. This annual report, Supplement 4, presents updated information as of September 30, 1994. This report gives a comprehensive description of the implementation and verification status of TMI Action Plan requirements, safety issues designated as USIs, GSIs, and other MPAs that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. Additionally, this report serves as a follow-on to NUREG-0933, ''A Prioritization of Generic Safety Issues,'' which tracks safety issues until requirements are approved for imposition at licensed plants or until the NRC issues a request for action by licensees

Drug Abuse on College Campuses: Emerging Issues. Issues in Prevention

Science.gov (United States)

Higher Education Center for Alcohol, Drug Abuse, and Violence Prevention, 2012

2012-01-01

This "Issues in Prevention" focuses on emerging issues concerning drug abuse on college campuses. This issue contains the following articles: (1) Drug Abuse Trends; (2) Q&A With Jim Lange; (3) Bath Salts; (4) Refuse to Abuse; (5) Related Federal Resource; and (6) Higher Education Center Resources.

Off-Label Drug Use in Pediatric Practice: Unsolved Problems

Directory of Open Access Journals (Sweden)

A. R. Titova

2015-01-01

Full Text Available The widespread «off-label» drug use and the prescribing of unlicensed medicines in pediatric practice is a major health problem. The authors discuss actual regulatory and legal issues of «off-label» drug use in children in the US, Europe and Russia. The results of different population-based studies from many countries, showing the structure and frequency of «off-label» drug use in children, are summarized in this article. It is shown that such practice increases the risk of adverse drug reactions. The authors offer practical recommendations for a safer use of drugs in pediatric practice. The priority issue is conducting high quality clinical trials with the participation of children, improving national pharmacovigilance and the monitoring of off-label drug use, developing pediatric formularies, improving doctors’ knowledge and awareness of safety and efficacy of medicines in pediatric population.

Performance and blood monitoring in sports: the artificial intelligence evoking target testing in antidoping (AR.I.E.T.T.A.) project.

Science.gov (United States)

Manfredini, A F; Malagoni, A M; Litmanen, H; Zhukovskaja, L; Jeannier, P; Dal Follo, D; Felisatti, M; Besseberg, A; Geistlinger, M; Bayer, P; Carrabre, J E

2011-03-01

Substances and methods used to increase oxygen blood transport and physical performance can be detected in the blood, but the screening of the athletes to be tested remains a critical issue for the International Federations. This project, AR.I.E.T.T.A., aimed to develop a software capable of analysing athletes' hematological and performance profiles to detect abnormal patterns. One-hundred eighty athletes belonging to the International Biathlon Union gave written informed consent to have their hematological data, previously collected according to anti-doping rules, used to develop the AR.I.E.T.T.A. software. Software was developed with the included sections: 1) log-in; 2) data-entry: where data are loaded, stored and grouped; 3) analysis: where data are analysed, validated scores are calculated, and parameters are simultaneously displayed as statistics, tables and graphs, and individual or subpopulation profiles; 4) screening: where an immediate evaluation of the risk score of the present sample and/or the athlete under study is obtained. The sample risk score or AR.I.E.T.T.A. score is calculated by a simple computational system combining different parameters (absolute values and intra-individual variations) considered concurrently. The AR.I.E.T.T.A. score is obtained by the sum of the deviation units derived from each parameter, considering the shift of the present value from the reference values, based on the number of standard deviations. AR.I.E.T.T.A. enables a quick evaluation of blood results assisting surveillance programs and perform timely target testing controls on athletes by the International Federations. Future studies aiming to validate the AR.I.E.T.T.A. score and improve the diagnostic accuracy will improve the system.

Combination treatment with T4 and T3: toward personalized replacement therapy in hypothyroidism?

Science.gov (United States)

Biondi, Bernadette; Wartofsky, Leonard

2012-07-01

Levothyroxine therapy is the traditional lifelong replacement therapy for hypothyroid patients. Over the last several years, new evidence has led clinicians to evaluate the option of combined T(3) and T(4) treatment to improve the quality of life, cognition, and peripheral parameters of thyroid hormone action in hypothyroidism. The aim of this review is to assess the physiological basis and the results of current studies on this topic. We searched Medline for reports published with the following search terms: hypothyroidism, levothyroxine, triiodothyronine, thyroid, guidelines, treatment, deiodinases, clinical symptoms, quality of life, cognition, mood, depression, body weight, heart rate, cholesterol, bone markers, SHBG, and patient preference for combined therapy. The search was restricted to reports published in English since 1970, but some reports published before 1970 were also incorporated. We supplemented the search with records from personal files and references of relevant articles and textbooks. Parameters analyzed included the rationale for combination treatment, the type of patients to be selected, the optimal T(4)/T(3) ratio, and the potential benefits of this therapy on symptoms of hypothyroidism, quality of life, mood, cognition, and peripheral parameters of thyroid hormone action. The outcome of our analysis suggests that it may be time to consider a personalized regimen of thyroid hormone replacement therapy in hypothyroid patients. Further prospective randomized controlled studies are needed to clarify this important issue. Innovative formulations of the thyroid hormones will be required to mimic a more perfect thyroid hormone replacement therapy than is currently available.

Predicting the behavioural impact of transcranial direct current stimulation: issues and limitations

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Archy Otto De Berker

2013-10-01

Full Text Available The transcranial application of weak currents to the human brain has enjoyed a decade of success, providing a simple and powerful tool for non-invasively altering human brain function. However, our understanding of current delivery and its impact upon neural circuitry leaves much to be desired. We argue that the credibility of conclusions drawn with tDCS is contingent upon realistic explanations of how tDCS works, and that our present understanding of tDCS limits the technique’s use to localize function in the human brain. We outline two central issues where progress is required: the localization of currents, and predicting their functional consequence. We encourage experimenters to eschew simplistic explanations of mechanisms of transcranial current stimulation. We suggest the use of individualized current modelling, together with computational neurostimulation to inform mechanistic frameworks in which to interpret the physiological impact of tDCS. We hope that through mechanistically richer descriptions of current flow and action, insight into the biological processes by which transcranial currents influence behaviour can be gained, leading to more effective stimulation protocols and empowering conclusions drawn with tDCS.

Beta band transcranial alternating (tACS and direct current stimulation (tDCS applied after initial learning facilitate retrieval of a motor sequence

Directory of Open Access Journals (Sweden)

Vanessa eKrause

2016-01-01

Full Text Available The primary motor cortex (M1 contributes to the acquisition and early consolidation of a motor sequence. Although the relevance of M1 excitability for motor learning has been supported, the significance of M1 oscillations remains an open issue. This study aims at investigating to what extent retrieval of a newly learned motor sequence can be differentially affected by motor-cortical transcranial alternating (tACS and direct current stimulation (tDCS. Alpha (10 Hz, beta (20 Hz or sham tACS was applied in 36 right-handers. Anodal or cathodal tDCS was applied in 30 right-handers. Participants learned an eight-digit serial reaction time task (SRTT; sequential vs. random with the right hand. Stimulation was applied to the left M1 after SRTT acquisition at rest for ten minutes. Reaction times were analyzed at baseline, end of acquisition, retrieval immediately after stimulation and reacquisition after eight further sequence repetitions.Reaction times during retrieval were significantly faster following 20 Hz tACS as compared to 10 Hz and sham tACS indicating a facilitation of early consolidation. TDCS yielded faster reaction times, too, independent of polarity. No significant differences between 20 Hz tACS and tDCS effects on retrieval were found suggesting that 20 Hz effects might be associated with altered motor-cortical excitability. Based on the behavioural modulation yielded by tACS and tDCS one might speculate that altered motor-cortical beta oscillations support early motor consolidation possibly associated with neuroplastic reorganization.

Internet of Things in Marketing: Opportunities and Security Issues

Science.gov (United States)

Abashidze, Irakli; Dąbrowski, Marcin

2016-12-01

Internet of Things (IoT) affects different areas of human activities: everyday life of ordinary citizens, work style of marketing teams, factories and even entire cities. Large companies try to implement the technology in their marketing strategy that reshapes not only communication style and product promotion but consumers' expectations, perceptions and requirements towards companies. IoT is expected to become a huge network that will encompass not only smart devices but significantly influence humans' behavior, in this particular case - decision making style in different phases of purchase process. Therefore, the need for comprehensive scientific research is necessary. The issue needs to be reviewed from various points of view, such as opportunities, advantages, disadvantages, legal and technical considerations. The paper is an attempt to review different aspects of using Internet of Things for marketing purposes, identify some of the major problems and present possible ways of solution.

Effect of Localized Corrosion on Fatigue-Crack Growth in 2524-T3 and 2198-T851 Aluminum Alloys Used as Aircraft Materials

Science.gov (United States)

Moreto, J. A.; Broday, E. E.; Rossino, L. S.; Fernandes, J. C. S.; Bose Filho, W. W.

2018-03-01

Corrosion and fatigue of aluminum alloys are major issues for the in-service life assessment of aircraft structures and for the management of aging air fleets. The aim of this work was to evaluate the effect of localized corrosion on fatigue crack growth (FCG) resistance of the AA2198-T851 Al-Li alloy (Solution Heat Treated, Cold Worked, and Artificially Aged), comparing it with the FCG resistance of AA2524-T3 (Solution Heat Treated and Cold Worked), considering the effect of seawater fog environment. Before fatigue tests, the corrosion behavior of 2198-T851 and 2524-T3 aluminum alloys was verified using open circuit potential and potentiodynamic polarization techniques. Fatigue in air and corrosion fatigue tests were performed applying a stress ratio (R) of 0.1, 15 Hz (air) and 0.1 Hz (seawater fog) frequencies, using a sinusoidal waveform in all cases. The results showed that the localized characteristics of the 2198-T851 and 2524-T3 aluminum alloys are essentially related to the existence of intermetallic compounds, which, due to their different nature, may be cathodic or anodic in relation to the aluminum matrix. The corrosive medium has affected the FCG rate of both aluminum alloys, in a quite similar way.

The Role of Physical Layer Security in IoT: A Novel Perspective

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Tommaso Pecorella

2016-08-01

Full Text Available This paper deals with the problem of securing the configuration phase of an Internet of Things (IoT system. The main drawbacks of current approaches are the focus on specific techniques and methods, and the lack of a cross layer vision of the problem. In a smart environment, each IoT device has limited resources and is often battery operated with limited capabilities (e.g., no keyboard. As a consequence, network security must be carefully analyzed in order to prevent security and privacy issues. In this paper, we will analyze the IoT threats, we will propose a security framework for the device initialization and we will show how physical layer security can effectively boost the security of IoT systems.

Chimeric antigen receptors for adoptive T cell therapy in acute myeloid leukemia

Directory of Open Access Journals (Sweden)

Mingxue Fan

2017-08-01

Full Text Available Abstract Currently, conventional therapies for acute myeloid leukemia (AML have high failure and relapse rates. Thus, developing new strategies is crucial for improving the treatment of AML. With the clinical success of anti-CD19 chimeric antigen receptor (CAR T cell therapies against B-lineage malignancies, many studies have attempted to translate the success of CAR T cell therapy to other malignancies, including AML. This review summarizes the current advances in CAR T cell therapy against AML, including preclinical studies and clinical trials, and discusses the potential AML-associated surface markers that could be used for further CAR technology. Finally, we describe strategies that might address the current issues of employing CAR T cell therapy in AML.

Leveraging Fog Computing for Scalable IoT Datacenter Using Spine-Leaf Network Topology

Directory of Open Access Journals (Sweden)

K. C. Okafor

2017-01-01

Full Text Available With the Internet of Everything (IoE paradigm that gathers almost every object online, huge traffic workload, bandwidth, security, and latency issues remain a concern for IoT users in today’s world. Besides, the scalability requirements found in the current IoT data processing (in the cloud can hardly be used for applications such as assisted living systems, Big Data analytic solutions, and smart embedded applications. This paper proposes an extended cloud IoT model that optimizes bandwidth while allowing edge devices (Internet-connected objects/devices to smartly process data without relying on a cloud network. Its integration with a massively scaled spine-leaf (SL network topology is highlighted. This is contrasted with a legacy multitier layered architecture housing network services and routing policies. The perspective offered in this paper explains how low-latency and bandwidth intensive applications can transfer data to the cloud (and then back to the edge application without impacting QoS performance. Consequently, a spine-leaf Fog computing network (SL-FCN is presented for reducing latency and network congestion issues in a highly distributed and multilayer virtualized IoT datacenter environment. This approach is cost-effective as it maximizes bandwidth while maintaining redundancy and resiliency against failures in mission critical applications.

Tank characterization report for single-shell tank 241-T-102

International Nuclear Information System (INIS)

Baldwin, J.H.

1997-01-01

A major function of the Tank Waste Remediation System (TWRS) is to characterize wastes in support of waste management and disposal activities at the Hanford Site. Analytical data from sampling and analysis, along with other available information about a tank, are compiled and maintained in a tank characterization report (TCR). This report and its appendixes serve as the TCR for single-shell tank 241-T-102. The objectives of this report are to use characterization data in response to technical issues associated with tank 241-T-102 waste; and to provide a standard characterization of this waste in terms of a best-basis inventory estimate. The response to technical issues is summarized in Section 2.0, and the best-basis inventory estimate is presented in Section 3.0. Recommendations regarding safety status and additional sampling needs are provided in Section 4.0. Supporting data and information are contained in the appendixes. This report supports the requirements of the Hanford Federal Facility Agreement and Consent Order milestone M-44-05. Characterization information presented in this report originated from sample analyses and known historical sources. The most recent core sampling of tank 241-T-102 (March 1993) predated the existence of data quality objectives (DQOs). An assessment of the technical issues from the currently applicable DQOs was made using data from the 1993 push mode core sampling event, a July 1994 grab sampling event, and a May 1996 vapor flammability measurement. Historical information for tank 241-T-102, provided in Appendix A, includes surveillance information, records pertaining to waste transfers and tank operations, and expected tank contents derived from a process knowledge model. Appendix B contains further sampling and analysis data from the March 1993 push mode core sampling event and data from the grab sampling event in August 1994 and May 1996 vapor flammability measurement. Of the two push mode cores taken in March of 1993, cores 55

Tank characterization report for single-shell tank 241-T-102

Energy Technology Data Exchange (ETDEWEB)

Baldwin, J.H.

1997-06-24

A major function of the Tank Waste Remediation System (TWRS) is to characterize wastes in support of waste management and disposal activities at the Hanford Site. Analytical data from sampling and analysis, along with other available information about a tank, are compiled and maintained in a tank characterization report (TCR). This report and its appendixes serve as the TCR for single-shell tank 241-T-102. The objectives of this report are to use characterization data in response to technical issues associated with tank 241-T-102 waste; and to provide a standard characterization of this waste in terms of a best-basis inventory estimate. The response to technical issues is summarized in Section 2.0, and the best-basis inventory estimate is presented in Section 3.0. Recommendations regarding safety status and additional sampling needs are provided in Section 4.0. Supporting data and information are contained in the appendixes. This report supports the requirements of the Hanford Federal Facility Agreement and Consent Order milestone M-44-05. Characterization information presented in this report originated from sample analyses and known historical sources. The most recent core sampling of tank 241-T-102 (March 1993) predated the existence of data quality objectives (DQOs). An assessment of the technical issues from the currently applicable DQOs was made using data from the 1993 push mode core sampling event, a July 1994 grab sampling event, and a May 1996 vapor flammability measurement. Historical information for tank 241-T-102, provided in Appendix A, includes surveillance information, records pertaining to waste transfers and tank operations, and expected tank contents derived from a process knowledge model. Appendix B contains further sampling and analysis data from the March 1993 push mode core sampling event and data from the grab sampling event in August 1994 and May 1996 vapor flammability measurement. Of the two push mode cores taken in March of 1993, cores 55

Liquid lithium loop system to solve challenging technology issues for fusion power plant

Science.gov (United States)

Ono, M.; Majeski, R.; Jaworski, M. A.; Hirooka, Y.; Kaita, R.; Gray, T. K.; Maingi, R.; Skinner, C. H.; Christenson, M.; Ruzic, D. N.

2017-11-01

Steady-state fusion power plant designs present major divertor technology challenges, including high divertor heat flux both in steady-state and during transients. In addition to these concerns, there are the unresolved technology issues of long term dust accumulation and associated tritium inventory and safety issues. It has been suggested that radiation-based liquid lithium (LL) divertor concepts with a modest lithium-loop could provide a possible solution for these outstanding fusion reactor technology issues, while potentially improving reactor plasma performance. The application of lithium (Li) in NSTX resulted in improved H-mode confinement, H-mode power threshold reduction, and reduction in the divertor peak heat flux while maintaining essentially Li-free core plasma operation even during H-modes. These promising results in NSTX and related modeling calculations motivated the radiative liquid lithium divertor concept and its variant, the active liquid lithium divertor concept, taking advantage of the enhanced or non-coronal Li radiation in relatively poorly confined divertor plasmas. To maintain the LL purity in a 1 GW-electric class fusion power plant, a closed LL loop system with a modest circulating capacity of ~1 l s-1 is envisioned. We examined two key technology issues: (1) dust or solid particle removal and (2) real time recovery of tritium from LL while keeping the tritium inventory level to an acceptable level. By running the LL-loop continuously, it can carry the dust particles and impurities generated in the vacuum vessel to the outside where the dust/impurities can be removed by relatively simple dust filter, cold trap and/or centrifugal separation systems. With ~1 l s-1 LL flow, even a small 0.1% dust content by weight (or 0.5 g s-1) suggests that the LL-loop could carry away nearly 16 tons of dust per year. In a 1 GW-electric (or ~3 GW fusion power) fusion power plant, about 0.5 g s-1 of tritium is needed to maintain the fusion fuel cycle

Pitfalls and major issues in the histologic diagnosis of peripheral T-cell lymphomas: results of the central review of 573 cases from the T-Cell Project, an international, cooperative study.

Science.gov (United States)

Bellei, Monica; Sabattini, Elena; Pesce, Emanuela Anna; Ko, Young-Hyeh; Kim, Won Seog; Cabrera, Maria Elena; Martinez, Virginia; Dlouhy, Ivan; Paes, Roberto Pinto; Barrese, Tomas; Vassallo, Josè; Tarantino, Vittoria; Vose, Julie; Weisenburger, Dennis; Rüdiger, Thomas; Federico, Massimo; Pileri, Stefano

2017-12-01

Peripheral T-cell lymphomas (PTCLs) comprise a heterogeneous group of neoplasms that are derived from post-thymic lymphoid cells at different stages of differentiation with different morphological patterns, phenotypes and clinical presentations. PTCLs are highly diverse, reflecting the diverse cells from which they can originate and are currently sub-classified using World Health Organization (WHO) 2008 criteria. In 2006 the International T-Cell Lymphoma Project launched the T-Cell Project, building on the retrospective study previously carried on by the network, with the aim to prospectively collect accurate data to improve knowledge on this group of lymphomas. Based on previously published reports from International Study Groups it emerged that rendering a correct classification of PTCLs is quite difficult because the relatively low prevalence of these diseases results in a lack of confidence by most pathologists. This is the reason why the T-Cell Project requested the availability of diagnostic material from the initial biopsy of each patient registered in the study in order to have the initial diagnosis centrally reviewed by expert hematopathologists. In the present report the results of the review process performed on 573 cases are presented. Overall, an incorrect diagnosis was centrally recorded in 13.1% cases, including 8.5% cases centrally reclassified with a subtype eligible for the project and 4.6% cases misclassified and found to be disorders other than T-cell lymphomas; 2.1% cases were centrally classified as T-Cell disorders not included in the study population. Thus, the T-Cell Project confirmed the difficulties in providing an accurate classification when a diagnosis of PTCLs is suspected, singled out the major pitfalls that can bias a correct histologic categorization and confirmed that a centralized expert review with the application of adequate diagnostic algorithms is mandatory when dealing with these tumours. Copyright © 2016 John Wiley & Sons

Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial.

Science.gov (United States)

Lopez-Gonzalez, Elena; Herdeiro, Maria T; Piñeiro-Lamas, María; Figueiras, Adolfo

2015-02-01

The yellow-card scheme continues to be one of the principal methods for signal generation in pharmacovigilance. Nevertheless, under-reporting, one of its disadvantages, delays alert signals and has a negative influence on public health. Educational interventions in pharmacovigilance may have a positive impact on the spontaneous reporting of adverse drug reactions (ADRs). To assess the duration of the effect and effectiveness of an educational intervention in pharmacovigilance designed to improve ADR reporting in a robust pharmacovigilance system. A spatial, cluster randomized controlled trial was conducted covering all National Health System physicians in the northwest of Spain and targeting those who were actively engaged in clinical practice (n = 7,498). Of these, 2,120 were assigned in three spatial clusters to the intervention group (six hospitals and 138 primary care centers) and 3,614 in four clusters to the control group (seven hospitals and 267 primary care centers). The educational intervention consisted of two complementary approaches--one active (group sessions), the other passive (educational material, reporting form)-implemented from November 2007 to December 2008, with a follow-up period of 8 months. Intervention participation was 53.7 % in a hospital setting and 60.5 % in primary care settings. ADR reporting in the intervention group increased by 65.4 % (95 % confidence interval [CI]: 8.2-153.4) across the follow-up. The ADR reporting rate per 1,000 physicians/year in the intervention group rose from 28.1 to 39.6 following the intervention (51.7 and 27.4 in the first and second 4-month period, respectively). For the intervention group, relative risk (RR) was 2.31 (95 % CI: 1.46-3.68) and 1.04 (95 % CI: 0.61-1.77) in the first and second 4-month period, respectively adjusted to baseline values. There was an increase in unexpected ADR reporting (RR 2.06, 95 % CI 1.19-3.55). Pharmacovigilance educational interventions that have proved effective can be

Critical safety issues in the design of fusion machines

International Nuclear Information System (INIS)

Kramer, W.

1991-01-01

In the course of developing fusion machines both general safety considerations and safety assessments for the various components and systems of actual machines increase in number and become more and more coherent. This is particularly true for the NET/ITER projects where safety analysis plays an increasing role for the design of the machine. Since in a D/T tokamak the radiological hazards will be dominant basic radiological safety objectives are discussed. Critical safety issues as identified in particular by the NET/ITER community are reviewed. Subsequently, issues of major concern are considered both for normal operation and for conceivable accidents. The following accidents are considered to be crucial: Loss of cooling in plasma facing components, loss of vacuum, tritium system failure, and magnet system failure. To mitigate accident consequences a confinement concept based on passive features and multiple barriers including detritiation and filtering has to be applied. The reactor building as final barrier needs special attention to cope with both internal and external hazards. (orig.)

Introduction to the Issue on Current Trends in Terahertz Photonics and Applications

DEFF Research Database (Denmark)

2013-01-01

Since the last special issue on terahertz science and technology, nearly three years have been passed. During this period, while there have been further developments in terahertz (THz) sources, detectors, materials, and applications, there have been new discoveries. The purpose of this issue of t...... reviews on recent THz research, the contributed papers cover a wide range of the cutting-edge research in the topics described earlier....... of the IEEE Journal of Selected Topics in Quantum Electronics (JSTQE) is to highlight the advances in materials, devices, and applications and new directions in the THz domain within the last three years. Broad technical areas include: 1) materials; 2) matamaterials, plasmonics, and plasmons; 3) techniques...... and effects; 4) generation and power scaling; 5) detectors; 6) devices; 7) applications. These key THz topics are discussed in both invited and contributed papers published in this issue, providing comprehensive overviews of the current status and future directions as well as publishing original results...

The explanation of muwālāt in Zuhaily’s exegesis “al Tafsir al munir”

Directory of Open Access Journals (Sweden)

Iman Kanani

2016-03-01

Full Text Available One of the crucial contemporary issues of Islamic thought that has brought complicated situation in Muslims states, on the one hand, and between Muslims and non-Muslims on the other hand, is the issue of muwālāt. The literal understanding of muwālāt has caused profound problems in human societies, especially in the multi-religion countries. This research clarifies the meaning of loyalty in the Qur’ān based on al-Zuḥayli’s exegesis by using analytical -inductive method. The present study also elucidates Al-Zuḥayli’s point of view towards spiritual muwālāt and humane social muwālāt in the Quran.Hence, the study reveals fruitful findings and output, indicating that al-Zuḥayli separated muwālāt to three categories; prohibited muwālāt, muwālāt that causes infidelity, and muwālāt which means nice cohabitation with others. Also, the study explores that al-Zuḥayli believes that the principle in relations with Non-Muslims is based on peace. Furtheremore, al-Zuḥayli pointed out that muwālāt is permissible when it benefits Muslim society and Non- Muslim are not fighting with or betraying Muslims. Also the study presents that al-Zuḥayli has distinguished between muwālāt that means monotheism and worshiping God, and other types of muwālāt.

Heart Disease Doesn't Care What You Wear | NIH MedlinePlus the Magazine

Science.gov (United States)

... version of this page please turn JavaScript on. Heart Disease Doesn't Care What You Wear Past Issues / ... matter how great you look on the outside, heart disease can strike on the inside. And being a ...

Seven Issues, Revisited

OpenAIRE

Whitehead, Jim; De Bra, Paul; Grønbæk, Kaj; Larsen, Deena; Legget, John; schraefel, monica m.c.

2002-01-01

It has been 15 years since the original presentation by Frank Halasz at Hypertext'87 on seven issues for the next generation of hypertext systems. These issues are: Search and Query Composites Virtual Structures Computation in/over hypertext network Versioning Collaborative Work Extensibility and Tailorability Since that time, these issues have formed the nucleus of multiple research agendas within the Hypertext community. Befitting this direction-setting role, the issues have been revisited ...

The superfluid diffusion equation S(T)(∂T/∂t) = ∇·[K(T)(∇T)1/3

International Nuclear Information System (INIS)

Dresner, L.

1990-06-01

This report deals with the superfluid diffusion equation, S(T)(∂T/∂t) = ∇·[K(T)(∇T) 1/3 ], which describes heat transport in turbulent helium-II (superfluid helium). Three methods of solution -- the method of similarity, the variational method, and the method of maximum/minimum principles -- are applied to this equation. The solutions discovered are helpful in addressing the use of helium-II in superconducting magnets and other applications. 22 refs., 23 figs., 3 tabs

Status of safety issues at licensed power plants: TMI action plan requirements, unresolved safety issues, generic safety issues

International Nuclear Information System (INIS)

1991-12-01

As part of ongoing US Nuclear Regulatory Commission (NRC) efforts to ensure the quality and accountability of safety issue information, a program was established whereby an annual NUREG report would be published on the status of licensee implementation and NRC verification of safety issues in major NRC requirements areas. This information was compiled and reported in three NUREG volumes. Volume 1, published in March 1991, addressed the status of of Three Mile Island (TMI) Action Plan Requirements. Volume 2, published in May 1991, addressed the status of unresolved safety issues (USIs). Volume 3, published in June 1991, addressed the implementation and verification status of generic safety issues (GSIs). This annual NUREG report combines these volumes into a single report and provides updated information as of September 30, 1991. The data contained in these NUREG reports are a product of the NRC's Safety Issues Management System (SIMS) database, which is maintained by the Project Management Staff in the Office of Nuclear Reactor Regulation and by NRC regional personnel. This report is to provide a comprehensive description of the implementation and verification status of TMI Action Plan Requirements, safety issues designated as USIs, and GSIs that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. An additional purpose of this NUREG report is to serve as a follow-on to NUREG-0933, ''A Prioritization of Generic Safety Issues,'' which tracks safety issues up until requirements are approved for imposition at licensed plants or until the NRC issues a request for action by licensees

Critical Professional Issues in Labour Force Development for Teachers with Children up to Two Years of Age: A New Zealand Perspective

Science.gov (United States)

Rockel, Jean

2014-01-01

This paper critically examines current concerns regarding professional issues in labour force development for teachers with children up to two years of age (UtoT). The concerns in New Zealand (NZ) relate to whether initial teacher-education (ITE) qualifications prepare teachers to work with children UtoT, involving synergy between ITE and the…

Chemical composition analysis of simulated waste glass T10-G-16A

Energy Technology Data Exchange (ETDEWEB)

Fox, K. M. [Savannah River Site (SRS), Aiken, SC (United States). Savannah River National Lab. (SRNL)

2015-08-01

In this report, SRNL provides chemical composition analyses of a simulated LAW glass designated T10-G-16A.The measured chemical composition data are reported and compared with the targeted values for each component. No issues were identified in reviewing the analytical data.

Exposure to anti-malarial drugs and monitoring of adverse drug reactions using toll-free mobile phone calls in private retail sector in Sagamu, Nigeria: implications for pharmacovigilance

Directory of Open Access Journals (Sweden)

Ogunwande Isiaka A

2011-08-01

Full Text Available Abstract Background Adverse drug reactions (ADRs contribute to ill-health or life-threatening outcomes of therapy during management of infectious diseases. The exposure to anti-malarial and use of mobile phone technology to report ADRs following drug exposures were investigated in Sagamu - a peri-urban community in Southwest Nigeria. Methods Purchase of medicines was actively monitored for 28 days in three Community Pharmacies (CP and four Patent and Proprietary Medicine Stores (PPMS in the community. Information on experience of ADRs was obtained by telephone from 100 volunteers who purchased anti-malarials during the 28-day period. Results and Discussion A total of 12,093 purchases were recorded during the period. Antibiotics, analgesics, vitamins and anti-malarials were the most frequently purchased medicines. A total of 1,500 complete courses of anti-malarials were purchased (12.4% of total purchases; of this number, purchases of sulphadoxine-pyrimethamine (SP and chloroquine (CQ were highest (39.3 and 25.2% respectiuvely. Other anti-malarials purchased were artesunate monotherapy (AS - 16.1%, artemether-lumefantrine (AL 10.0%, amodiaquine (AQ - 6.6%, quinine (QNN - 1.9%, halofantrine (HF - 0.2% and proguanil (PR - 0.2%. CQ was the cheapest (USD 0.3 and halofantrine the most expensive (USD 7.7. AL was 15.6 times ($4.68 more expensive than CQ. The response to mobile phone monitoring of ADRs was 57% in the first 24 hours (day 1 after purchase and decreased to 33% by day 4. Participants in this monitoring exercise were mostly with low level of education (54%. Conclusion The findings from this study indicate that ineffective anti-malaria medicines including monotherapies remain widely available and are frequently purchased in the study area. Cost may be a factor in the continued use of ineffective monotherapies. Availability of a toll-free telephone line may facilitate pharmacovigilance and follow up of response to medicines in a resource

Family Issues

Science.gov (United States)

... es Autismo? Family Issues Home / Living with Autism / Family Issues Stress Siblings A child’s autism diagnosis affects every member of the family in different ways. Parents/caregivers must now place their ... may put stress on their marriage, other children, work, finances, and ...

INTERNET OF THINGS IN MARKETING: OPPORTUNITIES AND SECURITY ISSUES

Directory of Open Access Journals (Sweden)

Irakli ABASHIDZE

2016-10-01

Full Text Available Internet of Things (IoT affects different areas of human activities: everyday life of ordinary citizens, work style of mar-keting teams, factories and even entire cities. Large companies try to implement the technology in their marketing strat-egy that reshapes not only communication style and product promotion but consumers’ expectations, perceptions and requirements towards companies. IoT is expected to become a huge network that will encompass not only smart devic-es but significantly influence humans’ behavior, in this particular case – decision making style in different phases of pur-chase process. Therefore, the need for comprehensive scientific research is necessary. The issue needs to be reviewed from various points of view, such as opportunities, advantages, disadvantages, legal and technical considerations. The paper is an attempt to review different aspects of using Internet of Things for marketing purposes, identify some of the major problems and present possible ways of solution.

Superconducting spiral phase in the two-dimensional t-J model

International Nuclear Information System (INIS)

Sushkov, Oleg P.; Kotov, Valeri N.

2004-01-01

We analyze the t-t ' -t '' -J model, relevant to the superconducting cuprates. By using chiral perturbation theory we have determined the ground state to be a spiral for small doping δ1 near half filling. In this limit the solution does not contain any uncontrolled approximations. We evaluate the spin-wave Green's functions and address the issue of stability of the spiral state, leading to the phase diagram of the model. At t ' =t '' =0 the spiral state is unstable towards a local enhancement of the spiral pitch, and the nature of the true ground state remains unclear. However, for values of t ' and t '' corresponding to real cuprates the (1,0) spiral state is stabilized by quantum fluctuations ('order from disorder' effect). We show that at δ≅0.119 the spiral is commensurate with the lattice with a period of eight lattice spacings. It is also demonstrated that spin-wave mediated superconductivity develops in the spiral state and a lower limit for the superconducting gap is derived. Even though one cannot classify the gap symmetry according to the lattice representations (s,p,d, ellipsis (horizontal)) since the symmetry of the lattice is spontaneously broken by the spiral, the gap always has lines of nodes along the (1,±1) directions

Establishing exchange bias below T-N with polycrystalline Ni0.52Co0.48O/Co bilayers

DEFF Research Database (Denmark)

Berkowitz, A.E.; Hansen, Mikkel Fougt; Tang, Y.J.

2005-01-01

Exchange-coupled bilayers of polycrystalline ferromagnetic (FM) Co on antiferromagnetic (AFM) Ni0.52Co0.48O were investigated with emphasis on the issue of establishing an exchange-bias field, H-E, below the AFM ordering temperature, T-N. It was found that field-cooling the bilayers through T-N p...

Explosive volcanism, shock metamorphism and the K-T boundary

International Nuclear Information System (INIS)

Desilva, S.L.; Sharpton, V.L.

1988-01-01

The issue of whether shocked quartz can be produced by explosive volcanic events is important in understanding the origin of the K-T boundary constituents. Proponents of a volcanic origin for the shocked quartz at the K-T boundary cite the suggestion of Rice, that peak overpressures of 1000 kbars can be generated during explosive volcanic eruptions, and may have occurred during the May, 1980 eruption of Mt. St. Helens. Attention was previously drawn to the fact that peak overpressures during explosive eruptions are limited by the strength of the rock confining the magma chamber to less than 8 kbars even under ideal conditions. The proposed volcanic mechanisms for generating pressures sufficient to shock quartz are further examined. Theoretical arguments, field evidence and petrographic data are presented showing that explosive volcanic eruptions cannot generate shock metamorphic features of the kind seen in minerals at the K-T boundary

20 CFR 725.463 - Issues to be resolved at hearing; new issues.

Science.gov (United States)

2010-04-01

... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Issues to be resolved at hearing; new issues... OF THE FEDERAL MINE SAFETY AND HEALTH ACT, AS AMENDED Hearings § 725.463 Issues to be resolved at hearing; new issues. (a) Except as otherwise provided in this section, the hearing shall be confined to...

Targeting CD8+ T-cell tolerance for cancer immunotherapy.

Science.gov (United States)

Jackson, Stephanie R; Yuan, Jinyun; Teague, Ryan M

2014-01-01

In the final issue of Science in 2013, the American Association of Science recognized progress in the field of cancer immunotherapy as the 'Breakthrough of the Year.' The achievements were actually twofold, owing to the early success of genetically engineered chimeric antigen receptors (CAR) and to the mounting clinical triumphs achieved with checkpoint blockade antibodies. While fundamentally very different, the common thread of these independent strategies is the ability to prevent or overcome mechanisms of CD8(+) T-cell tolerance for improved tumor immunity. Here we discuss how circumventing T-cell tolerance has provided experimental insights that have guided the field of clinical cancer immunotherapy to a place where real breakthroughs can finally be claimed.

Caterpillar C7 and GEP 6.5L (T) Fuel System Durability Using 25% ATJ Fuel Blend

Science.gov (United States)

2015-02-01

6.5L(T) diesel engines. With the technical issues presented in this report related to the CAT C7 evaluation and the desert operating condition GEP 6.5L...General Engine Products (GEP) 6.5L(T) diesel engines. These engines are representative of high density vehicles fielded by the U.S. Army tactical...Southwest Research Institute T - turbo TARDEC – Tank Automotive Research, Development, and Engineering Center TFLRF – TARDEC Fuels and Lubricants

Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.

Science.gov (United States)

Jullian, Sandra; Jaskiewicz, Lukasz; Pfannkuche, Hans-Jürgen; Parker, Jeremy; Lalande-Luesink, Isabelle; Lewis, David J; Close, Philippe

2015-09-01

Marketing authorization holders (MAHs) are expected to provide high-quality periodic safety update reports (PSURs) on their pharmaceutical products to health authorities (HAs). We present a novel instrument aiming at improving quality of PSURs based on standardized analysis of PSUR assessment reports (ARs) received from the European Union HAs across products and therapeutic areas. All HA comments were classified into one of three categories: "Request for regulatory actions," "Request for medical and scientific information," or "Data deficiencies." The comments were graded according to their impact on patients' safety, the drug's benefit-risk profile, and the MAH's pharmacovigilance system. A total of 476 comments were identified through the analysis of 63 PSUR HA ARs received in 2013 and 2014; 47 (10%) were classified as "Requests for regulatory actions," 309 (65%) as "Requests for medical and scientific information," and 118 (25%) comments were related to "Data deficiencies." The most frequent comments were requests for labeling changes (35 HA comments in 19 ARs). The aggregate analysis revealed commonly raised issues and prompted changes of the MAH's procedures related to the preparation of PSURs. The authors believe that this novel instrument based on the evaluation of PSUR HA ARs serves as a valuable mechanism to enhance the quality of PSURs and decisions about optimization of the use of the products and, therefore, contributes to improve further the MAH's pharmacovigilance system and patient safety. Copyright © 2015 John Wiley & Sons, Ltd.

Evaluation of MRI sequences for quantitative T1 brain mapping

Science.gov (United States)

Tsialios, P.; Thrippleton, M.; Glatz, A.; Pernet, C.

2017-11-01

T1 mapping constitutes a quantitative MRI technique finding significant application in brain imaging. It allows evaluation of contrast uptake, blood perfusion, volume, providing a more specific biomarker of disease progression compared to conventional T1-weighted images. While there are many techniques for T1-mapping there is a wide range of reported T1-values in tissues, raising the issue of protocols reproducibility and standardization. The gold standard for obtaining T1-maps is based on acquiring IR-SE sequence. Widely used alternative sequences are IR-SE-EPI, VFA (DESPOT), DESPOT-HIFI and MP2RAGE that speed up scanning and fitting procedures. A custom MRI phantom was used to assess the reproducibility and accuracy of the different methods. All scans were performed using a 3T Siemens Prisma scanner. The acquired data processed using two different codes. The main difference was observed for VFA (DESPOT) which grossly overestimated T1 relaxation time by 214 ms [126 270] compared to the IR-SE sequence. MP2RAGE and DESPOT-HIFI sequences gave slightly shorter time than IR-SE (~20 to 30ms) and can be considered as alternative and time-efficient methods for acquiring accurate T1 maps of the human brain, while IR-SE-EPI gave identical result, at a cost of a lower image quality.

Evaluation of MRI issues for a new neurological implant, the Sensor Reservoir.

Science.gov (United States)

Shellock, Frank G; Knebel, Jörg; Prat, Angelina D

2013-09-01

A new neurological implant, the Sensor-Reservoir, was developed to provide a relative measurement of ICP, which permits a noninvasive technique to detect and localize occlusions in ventricular drainage systems and, thus, to identify mechanical damage to shunt valves. The "reservoir" of this device can be used to administer medication or a contrast agent, to extract cerebral spinal fluid (CSF), and with the possibility of directly measuring ICP. The Sensor-Reservoir was evaluated to identify possible MRI-related issues at 1.5-T/64-MHz and 3-T/128-MHz. Standard testing techniques were utilized to evaluate magnetic field interactions (i.e., translational attraction and torque), MRI-related heating, and artifacts at 3-T for the Sensor-Reservoir. In addition, 12 samples of the Sensor-Reservoir underwent testing to determine if the function of these devices was affected by exposures to various MRI conditions at 1.5-T/64-MHz and 3-T/128-MHz. Magnetic field interactions for the Sensor-Reservoir were not substantial. The heating results indicated a highest temperature rise of 1.8 °C, which poses no patient risks. Artifacts were relatively small in relation to the size and shape of the Sensor-Reservoir, but may interfere diagnostically if the area of interest is near the device. All devices were unaffected by exposures to MRI conditions at 1.5-T/64-MHz and 3-T/128-MHz. When specific guidelines are followed, the Sensor-Reservoir is "MR conditional" for patients undergoing MRI examinations at 3-T or less. Copyright © 2013 Elsevier Inc. All rights reserved.

Methodological Issues In Forestry Mitigation Projects: A CaseStudy Of Kolar District

Energy Technology Data Exchange (ETDEWEB)

Ravindranath, N.H.; Murthy, I.K.; Sudha, P.; Ramprasad, V.; Nagendra, M.D.V.; Sahana, C.A.; Srivathsa, K.G.; Khan, H.

2007-06-01

There is a need to assess climate change mitigationopportunities in forest sector in India in the context of methodologicalissues such as additionality, permanence, leakage, measurement andbaseline development in formulating forestry mitigation projects. A casestudy of forestry mitigation project in semi-arid community grazing landsand farmlands in Kolar district of Karnataka, was undertaken with regardto baseline and project scenariodevelopment, estimation of carbon stockchange in the project, leakage estimation and assessment ofcost-effectiveness of mitigation projects. Further, the transaction coststo develop project, and environmental and socio-economic impact ofmitigation project was assessed.The study shows the feasibility ofestablishing baselines and project C-stock changes. Since the area haslow or insignificant biomass, leakage is not an issue. The overallmitigation potential in Kolar for a total area of 14,000 ha under variousmitigation options is 278,380 tC at a rate of 20 tC/ha for the period2005-2035, which is approximately 0.67 tC/ha/yr inclusive of harvestregimes under short rotation and long rotation mitigation options. Thetransaction cost for baseline establishment is less than a rupee/tC andfor project scenario development is about Rs. 1.5-3.75/tC. The projectenhances biodiversity and the socio-economic impact is alsosignificant.

First Measurement of σ(gg → t$\\bar{t}$)/σ(p$\\bar{p}$ → t$\\bar{t}$)

Energy Technology Data Exchange (ETDEWEB)

Alamdari, Shabnaz Pashapour [Univ. of Toronto, ON (Canada)

2008-01-01

The work presented here is the first measurement of the fraction of top quark pair production through gluon-gluon fusion. We use an integrated luminosity of 0.96 ± 0.06 fb^-1 of p{bar p} collisions at √s of 1.96 TeV collected by the CDF II detector. We select t$\\bar{t}$ candidates by identifying a high-p_T lepton candidate, a large missing E_T as evidence for a neutrino candidate and at least four high E_T jets, one of which has to be identified as originating from a b quark. The challenge is to discriminate between the two production processes with the identical final state, gg → t$\\bar{t}$ and q$\\bar{p}$ → t$\\bar{t}$. We take advantage of the fact that compared to a quark, a gluon is more likely to radiate a low momentum gluon and therefore, one expects a larger number of charged particles with low p_T in a process involving more gluons. Given the large uncertainties associated with the modeling of the low p_T charged particle multiplicity, a data-driven technique was employed. Using calibration data samples, we show there exists a clear correlation between the observed average number of low p_T charged particles and the average number of gluons involved in the production process predicted by Monte Carlo calculations. Given the correlation, one can identify low p_T charged particle multiplicity distributions associated with specific average number of gluons. The W + 0 jet sample and dijets sample with leading jet E_T in the range of 80-100 GeV are used to find no-gluon and gluon-rich low p{sub T} charged particle multiplicity distributions, respectively. Using these no-gluon and gluon-rich distributions in a likelihood fit, we find the fraction of gluon-rich events in t{bar t} candidates. This fraction has contributions from the signal and background events. Taking into account these contributions and the gg → t$\\bar{t}$ and q$\\bar{q}$ → t$\\bar{t

Elevated Expression of GlpT and UhpT via FNR Activation Contributes to Increased Fosfomycin Susceptibility in Escherichia coli under Anaerobic Conditions

Science.gov (United States)

Kurabayashi, Kumiko; Tanimoto, Koichi; Fueki, Shinobu; Tomita, Haruyoshi

2015-01-01

Because a shortage of new antimicrobial agents is a critical issue at present, and with the spread of multidrug-resistant (MDR) pathogens, the use of fosfomycin to treat infections is being revisited as a “last-resort option.” This drug offers a particular benefit in that it is more effective against bacteria growing under oxygen-limited conditions, unlike other commonly used antimicrobials, such as fluoroquinolones and aminoglycosides. In this study, we showed that Escherichia coli strains, including enterohemorrhagic E. coli (EHEC), were more susceptible to fosfomycin when grown anaerobically than when grown aerobically, and we investigated how the activity of this drug was enhanced during anaerobic growth of E. coli. Our quantitative PCR analysis and a transport assay showed that E. coli cells grown under anaerobic conditions had higher levels of expression of glpT and uhpT, encoding proteins that transport fosfomycin into cells with their native substrates, i.e., glycerol-3-phosphate and glucose-6-phosphate, and led to increased intracellular accumulation of the drug. Elevation of expression of these genes during anaerobic growth requires FNR, a global transcriptional regulator that is activated under anaerobic conditions. Purified FNR bound to DNA fragments from regions upstream of glpT and uhpT, suggesting that it is an activator of expression of glpT and uhpT during anaerobic growth. We concluded that the increased antibacterial activity of fosfomycin toward E. coli under anaerobic conditions can be attributed to elevated expression of GlpT and UhpT following activation of FNR, leading to increased uptake of the drug. PMID:26248376

From Imitation to Innovation: A Strategic Adjustment in China's S&T Development

Institute of Scientific and Technical Information of China (English)

Fang Xin

2005-01-01

@@ Since the latter half of 2004, China's top leaders have given higher priority to the issue of national capacity building for S&T innovation. Chinese President Hu Jintao reiterates that stress should be placed on the upgrading of innovation capacity when making overall plans for S&T development,and the task should remain the key link in promoting economic structural readjustment and raising national competitiveness. This strategic transition from imitation to innovation is also found in the National Long- &Medium-term Plan for S&T Development,which is being formulated under the leadership of Premier Wen Jiabao. The author explains the reason behind such a transition and the major administrative measures to be adopted for its implementation.

A neural network and IoT-based scheme for performance assessment in Internet of Robotic Things

OpenAIRE

Razafimandimby , Cristanel; Loscri , Valeria; Vegni , Anna Maria

2016-01-01

International audience; Internet of Robotic Things (IoRT) is a new concept introduced for the first time by ABI Research. Unlike the Internet of Things (IoT), IoRT provides an active sensorization and is considered as the new evolution of IoT. This new concept will bring new opportunities and challenges, while providing new business ideas for IoT and robotics’ entrepreneurs. In this paper, we will focus particularly on two issues: (i) connectivity maintenance among multiple IoRT robots, and (...

Discovery of a visual T-dwarf triple system and binarity at the L/T transition

Energy Technology Data Exchange (ETDEWEB)

Radigan, Jacqueline [Space Telescope Science Institute, 3700 San Martin Drive, Baltimore, MD 21218 (United States); Jayawardhana, Ray [Department of Astronomy and Astrophysics, University of Toronto, 50 St. George Street, Toronto, ON M5S 3H4 (Canada); Lafrenière, David [Département de Physique, Université de Montréal, C.P. 6128 Succ. Centre-Ville, Montréal, QC H3C 3J7 (Canada); Dupuy, Trent J. [Harvard-Smithsonian Center for Astrophysics, 60 Garden Street, Cambridge, MA 02138 (United States); Liu, Michael C. [Institute for Astronomy, University of Hawaii, 2680 Woodlawn Drive, Honolulu, HI 96822 (United States); Scholz, Alexander, E-mail: radigan@stsci.edu [School of Physics and Astronomy, University of St Andrews, North Haugh, St Andrews, KY169SS (United Kingdom)

2013-11-20

of L9-T4 at separations ≳ 0.''1. This translates into a volume-corrected frequency of 13{sub −6}{sup +7}%, which is similar to values of ∼9%-12% reported outside the transition. Our reported L/T transition binary fraction is roughly twice as large as the binary fraction of an equivalent L9-T4 sample selected from primary rather than unresolved spectral types (6{sub −4}{sup +6}%); however, this increase is not yet statistically significant and a larger sample is required to settle the issue.

The Internet of Things ecosystem: the blockchain and data protection issues

Directory of Open Access Journals (Sweden)

Nicola Fabiano

2018-03-01

Full Text Available The IoT is innovative and important phenomenon prone to several services and applications such as the blockchain which an emerging phenomenon. We can describe the blockchain as blockchain as a service because of the opportunity to use several applications based on this technology. We, indeed, should take into account the legal issues related to the data protection and privacy law to avoid breaches of the law. In this context, it is important to consider the new European General Data Protection Regulation (GDPR that will be in force on 25 May 2018. The contribution describes the main legal issues related to data protection and privacy focusing on the Data Protection by Design approach, according to the GDPR. Furthermore, I resolutely believe that is possible to develop a global privacy standard framework that organizations can use for their data protection activities.

Final report for the field-reversed configuration power plant critical-issue scoping study

Energy Technology Data Exchange (ETDEWEB)

Santarius, John F.; Mogahed, Elsayed A.; Emmert, Gilbert A.; Khater, Hesham Y.; Nguyen, Canh N.; Ryzhkov, Sergei V.; Stubna, Michael D.; Steinhauer, Loren C.; Miley, George H.

2001-03-01

This report describes research in which a team from the Universities of Wisconsin, Washington, and Illinois performed a scoping study of critical issues for field-reversed configuration (FRC) power plants. The key tasks for this research were (1) systems analysis of deuterium-tritium (D-T) FRC fusion power plants, and (2) conceptual design of the blanket and shield module for an FRC fusion core.

"We Haven't Done Enough for White Working-Class Children": Issues of Distributive Justice and Ethnic Identity Politics

Science.gov (United States)

Keddie, Amanda

2015-01-01

This article explores the politically contentious issue of White working-class student under-achievement within one particular school--a large and culturally diverse comprehensive secondary school in the greater London area. The article examines the equity philosophies and identity politics articulated by staff in their understanding of and…

Calibration issues for neutron diagnostics

International Nuclear Information System (INIS)

Sadler, G.J.; Adams, J.M.; Barnes, C.W.

1997-01-01

The performance of diagnostic systems are limited by their weakest constituents, including their calibration issues. Neutron diagnostics are notorious for problems encountered while determining their absolute calibrations, due mainly to the nature of the neutron transport problem. In order to facilitate the determination of an accurate and precise calibration, the diagnostic design should be such as to minimize the scattered neutron flux. ITER will use a comprehensive set of neutron diagnostics--comprising radial and vertical neutron cameras, neutron spectrometers, a neutron activation system and internal and external fission chambers--to provide accurate measurements of fusion power and power densities as a function of time. The calibration of such an important diagnostic system merits careful consideration. Some thoughts have already been given to this subject during the conceptual design phase in relation to the time-integrated neutron activation and time-dependent neutron yield monitors. However, no overall calibration strategy has been worked out so far. This paper represents a first attempt to address this vital issue. Experience gained from present large tokamaks (JET, TFTR and JT60U) and proposals for ITER are reviewed. The need to use a 14-MeV neutron generator as opposed to radioactive sources for in-situ calibration of D-T diagnostics will be stressed. It is clear that the overall absolute determination of fusion power will have to rely on a combination of nuclear measuring techniques, for which the provision of accurate and independent calibrations will constitute an ongoing process as ITER moves from one phase of operation to the next

New Strategies for the Treatment of Solid Tumors with CAR-T Cells.

Science.gov (United States)

Zhang, Hao; Ye, Zhen-Long; Yuan, Zhen-Gang; Luo, Zheng-Qiang; Jin, Hua-Jun; Qian, Qi-Jun

2016-01-01

Recent years, we have witnessed significant progresses in both basic and clinical studies regarding novel therapeutic strategies with genetically engineered T cells. Modification with chimeric antigen receptors (CARs) endows T cells with tumor specific cytotoxicity and thus induce anti-tumor immunity against malignancies. However, targeting solid tumors is more challenging than targeting B-cell malignancies with CAR-T cells because of the histopathological structure features, specific antigens shortage and strong immunosuppressive environment of solid tumors. Meanwhile, the on-target/off-tumor toxicity caused by relative expression of target on normal tissues is another issue that should be reckoned. Optimization of the design of CAR vectors, exploration of new targets, addition of safe switches and combination with other treatments bring new vitality to the CAR-T cell based immunotherapy against solid tumors. In this review, we focus on the major obstacles limiting the application of CAR-T cell therapy toward solid tumors and summarize the measures to refine this new cancer therapeutic modality.

Potential use of custirsen to treat prostate cancer

Directory of Open Access Journals (Sweden)

Higano CS

2013-06-01

Full Text Available Celestia S Higano Department of Medicine, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle, WA, USA Abstract: Over the last few years, five agents have demonstrated a survival benefit over a comparator treatment or placebo in the treatment of metastatic castration-resistant prostate cancer and have been approved by the US Food and Drug Administration: sipuleucel-T (a dendritic cell immunotherapy; cabazitaxel; abiraterone acetate and enzalutamide (both hormonal agents; and radium 223 (an alpha emitter. The development of these agents pivoted on whether patients had been treated with docetaxel, which remains the first-line chemotherapy of choice. To date, no combination of docetaxel and another active agent has demonstrated superiority to docetaxel alone despite numerous Phase III trials. Clusterin is a cytoprotective chaperone protein that is upregulated in response to various anticancer therapies. When overexpressed, clusterin interferes with apoptotic signaling, thereby promoting cell survival and conferring broad-spectrum resistance in cancer cell lines. Custirsen (OGX-011 is a second-generation 2´-methoxyethyl modified phosphorothioate antisense oligonucleotide that inhibits expression of clusterin. This review presents the preclinical and clinical data that provided the rationale for the combination of custirsen with chemotherapy in ongoing Phase III trials. Keywords: castration-resistant prostate cancer, clusterin, custirsen, OGX-011, antisense, OGX-427, apoptosis

Novel agents in the management of castration resistant prostate cancer

Directory of Open Access Journals (Sweden)

Shruti Chaturvedi

2014-01-01

Full Text Available Prostate cancer (PCa is a leading cause of cancer mortality in men and despite high cure rates with surgery and/or radiation, 30-40% of patients will eventually develop advanced disease. Androgen deprivation is the first line therapy for standard of care for men with advanced disease. Eventually however all men will progress to castration-resistant prostate cancer (CRPC. Insight into the molecular mechanisms of androgen resistance has led to the development of alternative novel hormonal agents. Newer hormonal agents such as abiraterone, enzalutamide and TOK-001; and the first cancer vaccine, Sipuleucel T have been approved for use in men with CRPC. The recognition of the importance of bone health and morbidity associated with skeletal related events has led to the introduction of the receptor activator of nuclear factor kappa-B-ligand inhibitor denosumab. Other molecularly targeted therapies have shown promise in pre-clinical studies, but this has not consistently translated into clinical efficacy. It is increasingly evident that CRPC is a heterogeneous disease and an individualized approach directed at identifying primary involvement of specific pathways could maximize the benefit from targeted therapies. This review focuses on targeted therapy for PCa with special emphasis on therapies that have been Food and Drug Administration approved for use in men with CRPC.

Ultra-clean Fischer-Tropsch (F-T) Fuels Production and Demonstration Project

Energy Technology Data Exchange (ETDEWEB)

Stephen P. Bergin

2006-06-30

lab evaluation; cold-start test-cell evaluations; overall feasibility, economics, and efficiency of SFP fuel production; and an economic analysis. Two unexpected issues that arose during the project were further studied and resolved: variations in NOx emissions were accounted for and fuel-injection nozzle fouling issues were traced to the non-combustible (ash) content of the engine oil, not the F-T fuel. The F-T fuel domestically produced and evaluated in this effort appears to be a good replacement candidate for petroleum-based transportation fuels. However, in order for domestic F-T fuels to become a viable cost-comparable alternative to petroleum fuels, the F-T fuels will need to be produced from abundant U.S. domestic resources such as coal and biomass, rather than stranded natural gas.

Practical comparison of distributed ledger technologies for IoT

Science.gov (United States)

Red, Val A.

2017-05-01

Existing distributed ledger implementations - specifically, several blockchain implementations - embody a cacophony of divergent capabilities augmenting innovations of cryptographic hashes, consensus mechanisms, and asymmetric cryptography in a wide variety of applications. Whether specifically designed for cryptocurrency or otherwise, several distributed ledgers rely upon modular mechanisms such as consensus or smart contracts. These components, however, can vary substantially among implementations; differences involving proof-of-work, practical byzantine fault tolerance, and other consensus approaches exemplify distinct distributed ledger variations. Such divergence results in unique combinations of modules, performance, latency, and fault tolerance. As implementations continue to develop rapidly due to the emerging nature of blockchain technologies, this paper encapsulates a snapshot of sensor and internet of things (IoT) specific implementations of blockchain as of the end of 2016. Several technical risks and divergent approaches preclude standardization of a blockchain for sensors and IoT in the foreseeable future; such issues will be assessed alongside the practicality of IoT applications among Hyperledger, Iota, and Ethereum distributed ledger implementations suggested for IoT. This paper contributes a comparison of existing distributed ledger implementations intended for practical sensor and IoT utilization. A baseline for characterizing distributed ledger implementations in the context of IoT and sensors is proposed. Technical approaches and performance are compared considering IoT size, weight, and power limitations. Consensus and smart contracts, if applied, are also analyzed for the respective implementations' practicality and security. Overall, the maturity of distributed ledgers with respect to sensor and IoT applicability will be analyzed for enterprise interoperability.

Nanoscale ferroelectrics and multiferroics key processes and characterization issues, and nanoscale effects

CERN Document Server

Alguero, Miguel

2016-01-01

This book reviews the key issues in processing and characterization of nanoscale ferroelectrics and multiferroics, and provides a comprehensive description of their properties, with an emphasis in differentiating size effects of extrinsic ones like boundary or interface effects. Recently described nanoscale novel phenomena are also addressed. Organized into three parts it addresses key issues in processing (nanostructuring), characterization (of the nanostructured materials) and nanoscale effects. Taking full advantage of the synergies between nanoscale ferroelectrics and multiferroics, it covers materials nanostructured at all levels, from ceramic technologies like ferroelectric nanopowders, bulk nanostructured ceramics and thick films, and magnetoelectric nanocomposites, to thin films, either polycrystalline layer heterostructures or epitaxial systems, and to nanoscale free standing objects with specific geometries, such as nanowires and tubes at different levels of development. The book is developed from t...

Presentation of lipid antigens to T cells.

Science.gov (United States)

Mori, Lucia; De Libero, Gennaro

2008-04-15

T cells specific for lipid antigens participate in regulation of the immune response during infections, tumor immunosurveillance, allergy and autoimmune diseases. T cells recognize lipid antigens as complexes formed with CD1 antigen-presenting molecules, thus resembling recognition of MHC-peptide complexes. The biophysical properties of lipids impose unique mechanisms for their delivery, internalization into antigen-presenting cells, membrane trafficking, processing, and loading of CD1 molecules. Each of these steps is controlled at molecular and celular levels and determines lipid immunogenicity. Lipid antigens may derive from microbes and from the cellular metabolism, thus allowing the immune system to survey a large repertoire of immunogenic molecules. Recognition of lipid antigens facilitates the detection of infectious agents and the initiation of responses involved in immunoregulation and autoimmunity. This review focuses on the presentation mechanisms and specific recognition of self and bacterial lipid antigens and discusses the important open issues.

incorporation of dpw, t]rea ant} fish meal with varying molasses ...

African Journals Online (AJOL)

Die vervanging van mieliemeel deur melasse teen peile van 7/o enH/oop ... teen. 'n hoer peil as ongeveer A/o t'7 die rantsoen ingesluit word nic. Die vitamien A inspuitings het gecn uitwerking op enige van die maatstawe gehad nie. Dit is dus duidelik ... Reference Issue (1976-77), Atlas of Nutritional Data on United States ...

Evaluation of MRI issues for an access port with a radiofrequency identification (RFID) tag.

Science.gov (United States)

Titterington, Blake; Shellock, Frank G

2013-10-01

A medical implant that contains metal, such as an RFID tag, must undergo proper MRI testing to ensure patient safety and to determine that the function of the RFID tag is not compromised by exposure to MRI conditions. Therefore, the objective of this investigation was to assess MRI issues for a new access port that incorporates an RFID tag. Samples of the access port with an RFID tag (Medcomp Power Injectable Port with CertainID; Medcomp, Harleysville, PA) were evaluated using standard protocols to assess magnetic field interactions (translational attraction and torque; 3-T), MRI-related heating (3-T), artifacts (3-T), and functional changes associated with different MRI conditions (nine samples, exposed to different MRI conditions at 1.5-T and 3-T). Magnetic field interactions were not substantial and will pose no hazards to patients. MRI-related heating was minimal (highest temperature change, 1.7°C; background temperature rise, 1.6°C). Artifacts were moderate in size in relation to the device. Exposures to MRI conditions at 1.5-T and 3-T did not alter or damage the functional aspects of the RFID tag. Based on the findings of the test, this new access port with an RFID tag is acceptable (or, MR conditional, using current MRI labeling terminology) for patients undergoing MRI examinations at 1.5-T/64-MHz and 3-T/128-MHz. Copyright © 2013 Elsevier Inc. All rights reserved.

Quark stars in f(T, T)-gravity

Energy Technology Data Exchange (ETDEWEB)

Pace, Mark; Said, Jackson Levi [University of Malta, Department of Physics, Msida (Malta); University of Malta, Institute of Space Sciences and Astronomy, Msida (Malta)

2017-02-15

We derive a working model for the Tolman-Oppenheimer-Volkoff equation for quark star systems within the modified f(T, T)-gravity class of models. We consider f(T, T)-gravity for a static spherically symmetric space-time. In this instance the metric is built from a more fundamental tetrad vierbein from which the metric tensor can be derived. We impose a linear f(T) parameter, namely taking f = αT(r) + βT(r) + φ and investigate the behaviour of a linear energy-momentum tensor trace, T. We also outline the restrictions which modified f(T, T)-gravity imposes upon the coupling parameters. Finally we incorporate the MIT bag model in order to derive the mass-radius and mass-central density relations of the quark star within f(T, T)-gravity. (orig.)

Sodium and T1rho MRI for molecular and diagnostic imaging of articular cartilage.

Science.gov (United States)

Borthakur, Arijitt; Mellon, Eric; Niyogi, Sampreet; Witschey, Walter; Kneeland, J Bruce; Reddy, Ravinder

2006-11-01

In this article, both sodium magnetic resonance (MR) and T1rho relaxation mapping aimed at measuring molecular changes in cartilage for the diagnostic imaging of osteoarthritis are reviewed. First, an introduction to structure of cartilage, its degeneration in osteoarthritis (OA) and an outline of diagnostic imaging methods in quantifying molecular changes and early diagnostic aspects of cartilage degeneration are described. The sodium MRI section begins with a brief overview of the theory of sodium NMR of biological tissues and is followed by a section on multiple quantum filters that can be used to quantify both bi-exponential relaxation and residual quadrupolar interaction. Specifically, (i) the rationale behind the use of sodium MRI in quantifying proteoglycan (PG) changes, (ii) validation studies using biochemical assays, (iii) studies on human OA specimens, (iv) results on animal models and (v) clinical imaging protocols are reviewed. Results demonstrating the feasibility of quantifying PG in OA patients and comparison with that in healthy subjects are also presented. The section concludes with the discussion of advantages and potential issues with sodium MRI and the impact of new technological advancements (e.g. ultra-high field scanners and parallel imaging methods). In the theory section on T1rho, a brief description of (i) principles of measuring T1rho relaxation, (ii) pulse sequences for computing T1rho relaxation maps, (iii) issues regarding radio frequency power deposition, (iv) mechanisms that contribute to T1rho in biological tissues and (v) effects of exchange and dipolar interaction on T1rho dispersion are discussed. Correlation of T1rho relaxation rate with macromolecular content and biomechanical properties in cartilage specimens subjected to trypsin and cytokine-induced glycosaminoglycan depletion and validation against biochemical assay and histopathology are presented. Experimental T1rho data from osteoarthritic specimens, animal models

Violation of causality in f(T) gravity

Energy Technology Data Exchange (ETDEWEB)

Otalora, G. [Pontificia Universidad Catolica de Valparaiso, Instituto de Fisica, Valparaiso (Chile); Reboucas, M.J. [Centro Brasileiro de Pesquisas Fisicas, Rio de Janeiro, RJ (Brazil)

2017-11-15

In the standard formulation, the f(T) field equations are not invariant under local Lorentz transformations, and thus the theory does not inherit the causal structure of special relativity. Actually, even locally violation of causality can occur in this formulation of f(T) gravity. A locally Lorentz covariant f(T) gravity theory has been devised recently, and this local causality problem seems to have been overcome. The non-locality question, however, is left open. If gravitation is to be described by this covariant f(T) gravity theory there are a number of issues that ought to be examined in its context, including the question as to whether its field equations allow homogeneous Goedel-type solutions, which necessarily leads to violation of causality on non-local scale. Here, to look into the potentialities and difficulties of the covariant f(T) theories, we examine whether they admit Goedel-type solutions. We take a combination of a perfect fluid with electromagnetic plus a scalar field as source, and determine a general Goedel-type solution, which contains special solutions in which the essential parameter of Goedel-type geometries, m{sup 2}, defines any class of homogeneous Goedel-type geometries. We show that solutions of the trigonometric and linear classes (m{sup 2} < 0 and m = 0) are permitted only for the combined matter sources with an electromagnetic field matter component. We extended to the context of covariant f(T) gravity a theorem which ensures that any perfect-fluid homogeneous Goedel-type solution defines the same set of Goedel tetrads h{sub A}{sup μ} up to a Lorentz transformation. We also showed that the single massless scalar field generates Goedel-type solution with no closed time-like curves. Even though the covariant f(T) gravity restores Lorentz covariance of the field equations and the local validity of the causality principle, the bare existence of the Goedel-type solutions makes apparent that the covariant formulation of f(T) gravity

Special Issue. 5th Meeting on Technology and Safety

International Nuclear Information System (INIS)

Kusakabe, Masashi; Kumagaya, Tadafusa; Minohara, Shinichi

2010-01-01

The documents in this Special Issue are the representative reports of achievements presented in the National Institute of Radiological Sciences (NIRS) 5th Meeting on Technology and Safety held on March 17, 2010. Personnel and investigators of NIRS and related companies gave their achievements by 19 oral and 31 poster presentations in fields of [IAR] irradiation (2 topics), accelerator/radiometry (9 topics), [EA] experimental animals (25 topics), [SM] safety management of facilities (5 topics), computer network system (4 topics), experimental instrument (1 topic), molecular imaging (2 topics) and others (2 topics). The Issue contains, as well as introductory and ending remarks, following 12 topics: [IAR] Working report of patient positioning system for radiotherapy with use of X-ray flat panel detector; Status of maintenance and management of facilities and equipments in Research center for Radiation Emergency Medicine; [EA] Past, present and future of mouse breeding in NIRS; Breeding of marmoset in NIRS/How can we have a bouncing marmoset baby?; Establishment of a genotyping method of transformed genes in transgenic mouse/genome walking method; Genetic monitoring system of mice by micro-satellite marker and its application in NIRS; Verification of sorting precision of FACSAria (Becton Dickinson and Co.), a highly sensitive, rapid sorting apparatus of cells/for precise sorting; Proposal of a task-solution workflow to determine the animal features for molecular imaging studies; [SM] Toward the introduction of Occupational Safety and Health Management System in NIRS; Use of unsealed radioisotopes less than the lower limit outside the legal control area; Arrangement of managing and supporting system for clinical studies; and Rearrangement of working system of personnel affairs. (T.T.)

Crowdsensing in Smart Cities: Overview, Platforms, and Environment Sensing Issues.

Science.gov (United States)

Alvear, Oscar; Calafate, Carlos T; Cano, Juan-Carlos; Manzoni, Pietro

2018-02-04

Evidence shows that Smart Cities are starting to materialise in our lives through the gradual introduction of the Internet of Things (IoT) paradigm. In this scope, crowdsensing emerges as a powerful solution to address environmental monitoring, allowing to control air pollution levels in crowded urban areas in a distributed, collaborative, inexpensive and accurate manner. However, even though technology is already available, such environmental sensing devices have not yet reached consumers. In this paper, we present an analysis of candidate technologies for crowdsensing architectures, along with the requirements for empowering users with air monitoring capabilities. Specifically, we start by providing an overview of the most relevant IoT architectures and protocols. Then, we present the general design of an off-the-shelf mobile environmental sensor able to cope with air quality monitoring requirements; we explore different hardware options to develop the desired sensing unit using readily available devices, discussing the main technical issues associated with each option, thereby opening new opportunities in terms of environmental monitoring programs.

CSC9000T A Toll Bell to“Sweat Shops”

Institute of Scientific and Technical Information of China (English)

2007-01-01

Deing a member of WTO doesn’t only mean having better opportunities in business,but also being responsible for the total welfare for the whole world. Chinese government expressed the Chinese care to environmental issues since 1992 Rio Earth Summit,and more than 150 NGOs are also mushrooming out of China,however CSR(Corporate Social Responsibility)is still something new to most companies in China. Environmental pollutions,factories of"sweatshops",low-wages, underaged workers,unsafe working conditions...After the crazy economic growth in 1990s,the Chinese enterprises,more or less,have begun to realize that an enterprise should be something more than a gold digger.Talking about social responsibilities,it seems textile industry needs a good thinking about the issue,since it offers jobs to 19.5 million employees.

Cross-Layer Energy Optimization for IoT Environments: Technical Advances and Opportunities

Directory of Open Access Journals (Sweden)

Kirshna Kumar

2017-12-01

Full Text Available Energy efficiency is a significant characteristic of battery-run devices such as sensors, RFID and mobile phones. In the present scenario, this is the most prominent requirement that must be served while introducing a communication protocol for an IoT environment. IoT network success and performance enhancement depend heavily on optimization of energy consumption that enhance the lifetime of IoT nodes and the network. In this context, this paper presents a comprehensive review on energy efficiency techniques used in IoT environments. The techniques proposed by researchers have been categorized based on five different layers of the energy architecture of IoT. These five layers are named as sensing, local processing and storage, network/communication, cloud processing and storage, and application. Specifically, the significance of energy efficiency in IoT environments is highlighted. A taxonomy is presented for the classification of related literature on energy efficient techniques in IoT environments. Following the taxonomy, a critical review of literature is performed focusing on major functional models, strengths and weaknesses. Open research challenges related to energy efficiency in IoT are identified as future research directions in the area. The survey should benefit IoT industry practitioners and researchers, in terms of augmenting the understanding of energy efficiency and its IoT-related trends and issues.

Campania preventability assessment committee: a focus on the preventability of the contrast media adverse drug reactions.

Science.gov (United States)

Sessa, Maurizio; Rossi, Claudia; Rafaniello, Concetta; Mascolo, Annamaria; Cimmaruta, Daniela; Scavone, Cristina; Fiorentino, Sonia; Grassi, Enrico; Reginelli, Alfonso; Rotondo, Antonio; Sportiello, Liberata

2016-12-01

The current study aims to assess the preventability of the contrast media adverse drug reactions reported through the Campania spontaneous reporting system, identifying the possible limitations emerged in this type of evaluation. All the individual case safety reports validated by the Campania Pharmacovigilance Regional Centre from July 2012 to September 2015 were screened to select those that reported contrast media as suspected drug. Campania Preventability Assessment Committee, in collaboration with clinicians specialized in Radiology, assessed the preventability according to the P-Method, through a case-by-case approach. From July 2012 to September 2015, 13798 cases were inserted by pharmacovigilance managers in the Italian Pharmacovigilance Network database (in the geographical contest of the Campania Region), of which 67 reported contrast media as suspected drug. Five preventable cases were found. The most reported causes for preventability were the inappropriate drug use for the case clinical conditions and the absence of the preventive measure administrated prior to the contrast media administration. Several limitations were found in the evaluation of the critical criteria for the preventability assessment. Educational initiatives will be organized directly to the healthcare professionals involved in the contrast media administration, to promote an appropriate use of the contrast media.

Long term energy-related environmental issues of copper production

International Nuclear Information System (INIS)

Alvarado, S.; Maldonado, P.; Barrios, A.; Jaques, I.

2002-01-01

Primary copper production is a major activity in the mining sector of several countries. However, it is highly energy-intensive and poses important environmental hazards. In the case of Chile, the world's largest copper producer (40% of world total), we examine its energy consumption and energy-related environmental implications over a time horizon of 25 years. Concerning the latter, we focus on greenhouse-gas (GHG) emissions, one of the most debated environmental issues. This paper follows up our previous report in which the current situation was analyzed and a particular technical option for improving the energy efficiency and concurrently reducing GHG emissions was discussed. Estimated reference or base (BS) and mitigation (MS) scenarios are developed for the period ending in 2020. The former assesses the energy demand projected in accordance with production forecasts and specific energy consumption patterns (assuming that energy efficiency measures are adopted 'spontaneously') with their resultant GHG emissions, while the latter assumes induced actions intended to reduce emissions by adopting an aggressive policy of efficient energy use. For the year 2020, the main results are: (i) BS, 1214 t of CO 2 /ton of refined copper content (49% lower than in 1994); (ii) MS, 1037 t of CO 2 /t of refined copper content (56% lower than in 1994). CO 2 emissions have been estimated considering both fuel and electricity process requirements. (author)

Non-trivial frames for f(T) theories of gravity and beyond

International Nuclear Information System (INIS)

Ferraro, Rafael; Fiorini, Franco

2011-01-01

Some conceptual issues concerning f(T) theories - a family of modified gravity theories based on absolute parallelism - are analyzed. Due to the lack of local Lorentz invariance, the autoparallel frames satisfying the field equations are evasive to an a priori physical understanding. We exemplify this point by working out the vierbein (tetrad) fields for closed and open Friedmann-Robertson-Walker cosmologies.

Non-trivial frames for f(T) theories of gravity and beyond

Energy Technology Data Exchange (ETDEWEB)

Ferraro, Rafael, E-mail: ferraro@iafe.uba.ar [Instituto de Astronomia y Fisica del Espacio, Casilla de Correo 67, Sucursal 28, 1428 Buenos Aires (Argentina); Departamento de Fisica, Facultad de Ciencias Exactas y Naturales, Universidad de Buenos Aires, Ciudad Universitaria, Pabellon I, 1428 Buenos Aires (Argentina); Fiorini, Franco, E-mail: franco@iafe.uba.ar [Instituto de Astronomia y Fisica del Espacio, Casilla de Correo 67, Sucursal 28, 1428 Buenos Aires (Argentina)

2011-08-03

Some conceptual issues concerning f(T) theories - a family of modified gravity theories based on absolute parallelism - are analyzed. Due to the lack of local Lorentz invariance, the autoparallel frames satisfying the field equations are evasive to an a priori physical understanding. We exemplify this point by working out the vierbein (tetrad) fields for closed and open Friedmann-Robertson-Walker cosmologies.

Integration of generic issues

International Nuclear Information System (INIS)

Thatcher, D.

1989-01-01

The NRC has recognized the need to integrate generic issues (GIs). The GI process includes a number of phases, all of which should recognize the potential for overlap and conflict among related issues. In addition to the issues themselves, other related NRC and industry programs and activities need to be factored into the GI process. Integration has taken place, or is taking place, for a number of GIs. Each case of integration involves a specific set of circumstances and, as a result, the way in which integration proceeds can vary. This paper discusses the integration of issues in the generic issue process and provides a number of examples

Medical Issues: Orthopedics

Science.gov (United States)

... Information Packets Equipment Pool Living With SMA Medical Issues Palliative Breathing Orthopedics Nutrition Equipment Daily Life At ... curesma.org > support & care > living with sma > medical issues > orthopedics Orthopedics In SMA, muscle weakness can cause ...

Medical Issues: Equipment

Science.gov (United States)

... Information Packets Equipment Pool Living With SMA Medical Issues Palliative Breathing Orthopedics Nutrition Equipment Daily Life At ... curesma.org > support & care > living with sma > medical issues > equipment Equipment Individuals with SMA often require a ...

Medical Issues: Breathing

Science.gov (United States)

... Information Packets Equipment Pool Living With SMA Medical Issues Palliative Breathing Orthopedics Nutrition Equipment Daily Life At ... curesma.org > support & care > living with sma > medical issues > breathing Breathing Breathing problems are the most common ...

Space Station Engineering Design Issues

Science.gov (United States)

Mcruer, Duane T.; Boehm, Barry W.; Debra, Daniel B.; Green, C. Cordell; Henry, Richard C.; Maycock, Paul D.; Mcelroy, John H.; Pierce, Chester M.; Stafford, Thomas P.; Young, Laurence R.

1989-01-01

Space Station Freedom topics addressed include: general design issues; issues related to utilization and operations; issues related to systems requirements and design; and management issues relevant to design.

Prioritization of generic safety issues

International Nuclear Information System (INIS)

Emrit, R.; Minners, W.; VanderMolen, H.

1983-12-01

This report presents the priority rankings for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The report focuses on the prioritization of generic safety issues. Issues primarily concerned with the licensing process or environmental protection and not directly related to safety have been excluded from prioritization. The prioritized issues include: TMI Action Plan items under development; previously proposed issues covered by Task Action Plans, except issues designated at Unresolved Safety Issues (USIs) which had already been assigned high priority; and newly-proposed issues. Future supplements to this report will include the prioritization of additional issues. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolutions of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative

Effects of potassium iodide in concentrations of TSH, tT3 and tT4 in serum of subjects with sporotrichosis.

Science.gov (United States)

Ramírez Soto, Max Carlos

2014-08-01

The saturated potassium iodide solution (SSKI) as treatment for sporotrichosis may cause hypothyroidism by suppressing the synthesis of thyroid hormones (tT3 and tT4 ) and the iodine excess could lead to thyrotoxicosis. Evaluating the changes in serum levels of TSH, tT3 and tT4 in euthyroid patients with sporotrichosis treated with SSKI. For the selection of euthyroid patients, TSH, tT3 and tT4 concentrations were measured for those adults and children diagnosed with sporotrichosis. Each paediatric patient was administered SSKI orally in increasing doses of 2-20 drops/3 times/day and 4-40 drops/3 times/day in adults. Serum concentrations of TSH, tT3 and tT4 were measured 20 days after started the treatment and 15 days posttreatment. Eight euthyroid patients aged between 2 to 65 years old were included. After 20 days of treatment, two suffered subclinical hypothyroidism, one developed subclinical hyperthyroidism, and one hyperthyroxinaemia euthyroid. At 15 days posttreatment only four patients were evaluated and all serum levels of TSH, tT3 and tT4 were normal. Some euthyroid patients with sporotrichosis can develop hyperthyroidism or subclinical iodine-induced hypothyroidism, during the administration of 3 or 6 g SSKI/day. © 2014 Blackwell Verlag GmbH.

Il-Musbieh : Malta Nursing and Midwifery Journal : Issue 27 : June 2005

OpenAIRE

Cini, Louise

2005-01-01

The aim of Il-Musbieh, Malta Nursing and Midwifery Journal, is to provide a link between the Malta Union of Midwives and Nurses (MUMN) and its members. In this issue : [Editorial] Bi ftit kuragg by Louise Cini – Message from the president by Rudolph Cini - Too many babies, don’t get counted – Kelmtejn mis-segretarju generali – Sub committee’s reports – L-influwenza tat-tjur by Amante Darmanin – Society’s contribution to mental illness by Stephen Demicoli – From our diary – Stop poverty by Arc...

Tribal-FERST Environmental Issue Profiles

Science.gov (United States)

This page provides links to the 45 issue profiles for Tribal-FERST users, organized with tabs to show issues related to pollutants, environmental media, health effects, other community issues, and all issues.

C-FERST Environmental Issue Profiles

Science.gov (United States)

This page provides links to the 45 issue profiles for C-FERST users, organized with tabs to show issues related to pollutants, environmental media, health effects, other community issues, and all issues.

Issues in Data Labelling

NARCIS (Netherlands)

Cowie, Roddy; Cox, Cate; Martin, Jeam-Claude; Batliner, Anton; Heylen, Dirk K.J.; Karpouzis, Kostas; Cowie, Roddy; Pelachaud, Catherine; Petta, Paolo

2011-01-01

Labelling emotion databases is not a purely technical matter. It is bound up with theoretical issues. Different issues affect labelling of emotional content, labelling of the signs that convey emotion, and labelling of the relevant context. Linked to these are representational issues, involving time

Synergy of combined tPA-edaravone therapy in experimental thrombotic stroke.

Science.gov (United States)

Sun, Yu-Yo; Morozov, Yury M; Yang, Dianer; Li, Yikun; Dunn, R Scott; Rakic, Pasko; Chan, Pak H; Abe, Koji; Lindquist, Diana M; Kuan, Chia-Yi

2014-01-01

Edaravone, a potent antioxidant, may improve thrombolytic therapy because it benefits ischemic stroke patients on its own and mitigates adverse effects of tissue plasminogen activator (tPA) in preclinical models. However, whether the combined tPA-edaravone therapy is more effective in reducing infarct size than singular treatment is uncertain. Here we investigated this issue using a transient hypoxia-ischemia (tHI)-induced thrombotic stroke model, in which adult C57BL/6 mice were subjected to reversible ligation of the unilateral common carotid artery plus inhalation of 7.5% oxygen for 30 min. While unilateral occlusion of the common carotid artery suppressed cerebral blood flow transiently, the addition of hypoxia triggered reperfusion deficits, endogenous thrombosis, and attenuated tPA activity, leading up to infarction. We compared the outcomes of vehicle-controls, edaravone treatment, tPA treatment at 0.5, 1, or 4 h post-tHI, and combined tPA-edaravone therapies with mortality rate and infarct size as the primary end-points. The best treatment was further compared with vehicle-controls in behavioral, biochemical, and diffusion tensor imaging (DTI) analyses. We found that application of tPA at 0.5 or 1 h--but not at 4 h post-tHI--significantly decreased infarct size and showed synergistic (pedaravone treatment, respectively. The acute tPA-edaravone treatment conferred >50% reduction of mortality, ∼ 80% decline in infarct size, and strong white-matter protection. It also improved vascular reperfusion and decreased oxidative stress, inflammatory cytokines, and matrix metalloproteinase activities. In conclusion, edaravone synergizes with acute tPA treatment in experimental thrombotic stroke, suggesting that clinical application of the combined tPA-edaravone therapy merits investigation.

Understanding Pregnancy and Birth Issues

Science.gov (United States)

... Navigation Bar Home Current Issue Past Issues Understanding Pregnancy and Birth Issues Past Issues / Winter 2008 Table ... turn Javascript on. What is a High-Risk Pregnancy? All pregnancies involve a certain degree of risk ...

Skin-resident CD4+ T cells protect against Leishmania major by recruiting and activating inflammatory monocytes

Science.gov (United States)

Glennie, Nelson D.; Volk, Susan W.

2017-01-01

Tissue-resident memory T cells are required for establishing protective immunity against a variety of different pathogens, although the mechanisms mediating protection by CD4+ resident memory T cells are still being defined. In this study we addressed this issue with a population of protective skin-resident, IFNγ-producing CD4+ memory T cells generated following Leishmania major infection. We previously found that resident memory T cells recruit circulating effector T cells to enhance immunity. Here we show that resident memory CD4+ T cells mediate the delayed-hypersensitivity response observed in immune mice and provide protection without circulating T cells. This protection occurs rapidly after challenge, and requires the recruitment and activation of inflammatory monocytes, which limit parasites by production of both reactive oxygen species and nitric oxide. Overall, these data highlight a novel role for tissue-resident memory cells in recruiting and activating inflammatory monocytes, and underscore the central role that skin-resident T cells play in immunity to cutaneous leishmaniasis. PMID:28419151

[MEOPA use practices in a university hospital: Which conformity?

Science.gov (United States)

Victorri-Vigneau, Caroline; Paille, Cécile; Joyau, Caroline; Veyrac, Gwenaëlle; Cosset, Claire; Le Pelletier, Aline; Jolliet, Pascale; Nizard, Julien; Kuhn, Emmanuelle

2017-12-01

MEOPA (equimolar mixture of oxygen and nitrous oxide) is used for its analgesic and anxiolytic properties in order to obtain conscious sedation of the patient when performing painful care. It is subject to an enhanced pharmacovigilance and addictovigilance monitoring. In this context, it is important to dispose of hospital utilization data. This work aims to assess the compliance of the use of nitrous oxide regarding the recommendations of the summary of product characteristics, in a French university hospital (Nantes) and consider possible improvements. Transversal descriptive study, conducted in 2014 with all health professionals using MEOPA. Two thousand thirty-four health professionals answered the questionnaire ; durations of administrations are in conformity and the premises are generally appropriate but almost 60% of professionals have the feeling of inhaling the drug. The systematization of the prescription (always or almost always prescribed for 67% of professionals) and traceability of use (always or almost always in the patient's file for 71% of professionals) are potential source of improvement, particularly since 18% of professional health reported "abuse demands" from patients. The formation and information of health professionals are major issues of good use of nitrous oxide. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

Selection and characterization of T-cell variants lacking molecules involved in T-cell activation (T3 T-cell receptor, T44, and T11): analysis of the functional relationship among different pathways of activation

International Nuclear Information System (INIS)

Moretta, A.; Poggi, A.; Olive, D.; Bottino, C.; Fortis, C.; Pantaleo, G.; Moretta, L.

1987-01-01

A clone of the interleukin 2-producing Jurkat leukemia cell line termed JA3 (surface phenotype, T3 + , Ti + , T44 + , T11 + , T40 + ) has been used to induce and select cell variants lacking surface molecules involved in T-cell activation. Following 200 rad of γ-radiation (1 rad = 0.01 Gy), cells were treated with monoclonal antibodies (mAbs) directed to T3, Ti, T44, or T11 antigen and complement. After growth of the residual cells in culture, negative cells were cloned under limiting conditions. Depending on the specificity of the mAb used for the immunoselection, three groups of variants were obtained. (i) The use of mAbs directed to T3 or Ti resulted in cell variants that expressed the T3 - Ti - T44 + Leu1 + T11 + T40 + 4F2 + HLA class I + surface phenotype. (ii) Immunoselection with anti-T44 mAb resulted in 2 variants that shared the T3 - Ti - T44 - Leu1 - T11 - T40 - 4F2 - HLA class I + phenotype. (iii) Cell treatment with anti-T11 mAb resulted in 15 variants characterized by the lack of T11 antigen expression and of all the other T-cell-specific surface antigens. Therefore, it appears that the different sets of JA3 cell variants, like T cells at discrete stages of intrathymic differentiation, may follow a coordinated expression of surface differentiation antigens. Analysis of the functional responsiveness of the three distinct groups of JA3 cell variants to different stimuli showed that all produced interleukin 2 in response to A23187 calcium ionophore plus phorbol 12-myristate 13-acetate

Poisson-Lie T-duality open strings and D-branes

CERN Document Server

Klimcik, C.

1996-01-01

Global issues of the Poisson-Lie T-duality are addressed. It is shown that oriented open strings propagating on a group manifold G are dual to D-brane - anti-D-brane pairs propagating on the dual group manifold \\ti G. The D-branes coincide with the symplectic leaves of the standard Poisson structure induced on the dual group \\ti G by the dressing action of the group G. T-duality maps the momentum of the open string into the mutual distance of the D-branes in the pair. The whole picture is then extended to the full modular space M(D) of the Poisson-Lie equivalent \\si-models which is the space of all Manin triples of a given Drinfeld double.T-duality rotates the zero modes of pairs of D-branes living on targets belonging to M(D). In this more general case the D-branes are preimages of symplectic leaves in certain Poisson homogeneous spaces of their targets and, as such, they are either all even or all odd dimensional.

Hearing impairment associated with oral terbinafine use: a case series and case/non-case analysis in the Netherlands Pharmacovigilance Centre Lareb database and VigiBase™.

Science.gov (United States)

Scholl, Joep H G; van Puijenbroek, Eugene P

2012-08-01

The Netherlands Pharmacovigilance Centre Lareb received reports of six cases of hearing impairment in association with oral terbinafine use. This study describes these cases and provides support for this association from the Lareb database for spontaneous adverse drug reaction (ADR) reporting and from Vigibase™, the ADR database of the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre. The objective of the current study was to identify whether the observed association between oral terbinafine use and hearing impairment, based on cases received by Lareb, constitutes a safety signal. Cases of hearing impairment in oral terbinafine users are described. In a case/non-case analysis, the strength of the association in Vigibase™ and the Lareb database was determined (date of analysis August 2011) by calculating the reporting odds ratios (RORs), adjusted for possible confounding by age, sex and ototoxic concomitant medication. For the purpose of this study, RORs were calculated for deafness, hypoacusis and the combination of both, defined as hearing impairment. In the Lareb database, six reports concerning individuals aged 31-82 years, who developed hearing impairment after starting oral terbinafine, were present. The use of oral terbinafine was disproportionally associated with hypoacusis in both the Lareb database (adjusted ROR 3.9; 95% CI 1.7, 9.0) and in Vigibase™ (adjusted ROR 1.7; 95% CI 1.0, 2.8). Deafness was not disproportionally present in either of the databases. Based on the described cases and the statistical analyses from both databases, a causal relationship between the use of oral terbinafine and hearing impairment is possible. The mechanism by which terbinafine could cause hearing impairment has not been elucidated yet. The pharmacological action of terbinafine is based on the inhibition of squalene epoxidase, an enzyme present in both fungal and human cells. This inhibition might result in a decrease in

19 (Special Issue)

African Journals Online (AJOL)

mwakagugu

19 (Special Issue). Tanzania Dental Journal 2017. 1. PRESIDENTS SPEECH AT THE OPENING CEREMONY OF THE TANZANIA DENTAL. ASSOCIATION 31ST SCIENTIFIC CONFERENCE AND .... awareness on oral health issues, high tooth decay, gum diseases and predominant tooth extraction as consistently reported ...

Synergy of combined tPA-edaravone therapy in experimental thrombotic stroke.

Directory of Open Access Journals (Sweden)

Yu-Yo Sun

Full Text Available Edaravone, a potent antioxidant, may improve thrombolytic therapy because it benefits ischemic stroke patients on its own and mitigates adverse effects of tissue plasminogen activator (tPA in preclinical models. However, whether the combined tPA-edaravone therapy is more effective in reducing infarct size than singular treatment is uncertain. Here we investigated this issue using a transient hypoxia-ischemia (tHI-induced thrombotic stroke model, in which adult C57BL/6 mice were subjected to reversible ligation of the unilateral common carotid artery plus inhalation of 7.5% oxygen for 30 min. While unilateral occlusion of the common carotid artery suppressed cerebral blood flow transiently, the addition of hypoxia triggered reperfusion deficits, endogenous thrombosis, and attenuated tPA activity, leading up to infarction. We compared the outcomes of vehicle-controls, edaravone treatment, tPA treatment at 0.5, 1, or 4 h post-tHI, and combined tPA-edaravone therapies with mortality rate and infarct size as the primary end-points. The best treatment was further compared with vehicle-controls in behavioral, biochemical, and diffusion tensor imaging (DTI analyses. We found that application of tPA at 0.5 or 1 h--but not at 4 h post-tHI--significantly decreased infarct size and showed synergistic (p50% reduction of mortality, ∼ 80% decline in infarct size, and strong white-matter protection. It also improved vascular reperfusion and decreased oxidative stress, inflammatory cytokines, and matrix metalloproteinase activities. In conclusion, edaravone synergizes with acute tPA treatment in experimental thrombotic stroke, suggesting that clinical application of the combined tPA-edaravone therapy merits investigation.

Uranium and nuclear issues

International Nuclear Information System (INIS)

1983-01-01

This seminar focussed on the major issues affecting the future of the entire nuclear fuel cycle. In particular it covered issues bearing on the formation of public policy in relation to the use of uranium as an energy source: economic risk, industrial risks, health effects, site selection, environmental issues, and public acceptance

Endocrinological issues and hormonal manipulation in children and men with Klinefelter syndrome.

Science.gov (United States)

Wosnitzer, Matthew S; Paduch, Darius A

2013-02-15

47, XXY or Klinefelter syndrome (KS), the most common chromosomal aberration in males, is characterized by either absolute or relative hypogonadism with frequent decline in serum testosterone (T) following the onset of puberty. Decreased T levels are the result of testicular dysfunction with decrease in size of Leydig cells, and loss of germs and Sertoli cells leading to tubular hyalinization. Increase in estradiol results from over-expression of aromatase CYP19. Deficient androgen production and observed varied response of end-organs to T leads to delayed progression of puberty with decreased facial/body hair, poor muscle development, osteoporosis, and gynecomastia. It is possible that hypogonadism and excessive estradiol production contribute to emotional and social immaturity, and specific learning disabilities in KS. Based on the authors' experience and literature review, early fertility preservation and hormonal supplementation may normalize pubertal development, prevent metabolic sequelae of hypogonadism, and have a positive effect on academic and social development. No randomized clinical trials are available studying the effects of T supplementation on reproductive or cognitive issues in KS. Aggressive T supplementation (topical gel) and selective use of aromatase inhibitors may be considered at the onset of puberty with careful follow-up and titration to reach age-specific high-normal physiologic serum values. The decision to institute hormonal therapy should be part of a multidisciplinary approach including physical, speech, behavioral, and occupational therapy. © 2013 Wiley Periodicals, Inc. Copyright © 2013 Wiley Periodicals, Inc.

The Role of Telehealth to Assist In-Home tDCS: Opportunities, Promising Results and Acceptability

Directory of Open Access Journals (Sweden)

Brenton Hordacre

2018-06-01

Full Text Available Transcranial direct current stimulation (tDCS has shown great promise as a neuromodulatory intervention capable of improving behavioral outcomes in a range of neurological and psychiatric populations. Evidence indicates that the neuromodulatory effect of stimulation may be cumulative, with greater improvements in behavior observed following multiple treatment sessions. However, the requirement to attend clinical or research departments for multiple treatment sessions may present a barrier for many people, particularly those with greater disability or living remotely. The portability of tDCS suggests that in-home stimulation may become an avenue for further investigation. However, safe and effective use of tDCS by a participant within their home requires a form of monitoring. This review discusses how telehealth may provide real-time visual monitoring to ensure correct tDCS set-up and adherence to stimulation protocols, manage technical issues and monitor adverse events. The combination of telehealth to supplement in-home tDCS use has potential to transform the way tDCS is delivered.

Special issue - Applying the accelerator

International Nuclear Information System (INIS)

Anon.

1995-01-01

T'he CERN Courier is the international journal of high energy physics, covering current developments in and around this branch of basic science. A recurrent theme is applying the technology developed for particle accelerators, the machines which produce beams of high energy particles for physics experiments. Twentieth-century science is full of similar examples of applications derived from pure research. This special issue of the CERN Courier is given over to one theme - the applications of accelerators. Accelerator systems and facilities are normally associated with highenergy particle physics research, the search for fundamental particles and the quest to understand the physics of the Big Bang. To the layman, accelerator technology has become synonymous with large and expensive machines, exploiting the most modern technology for basic research. In reality, the range of accelerators and their applications is much broader. A vast number of accelerators, usually much smaller and operating for specific applications, create wealth and directly benefit the population, particularly in the important areas of healthcare, energy and the environment. There are well established applications in diagnostic and therapeutic medicine for research and routine clinical treatments. Accelerators and associated technologies are widely employed by industry for manufacturing and process control. In fundamental and applied research, accelerator systems are frequently used as tools. The biennial conference on the Applications of Accelerators in Industry and Research at Denton, Texas, attracts a thousand participants. This special issue of the CERN Courier includes articles on major applications, reflecting the diversity and value of accelerator technology. Under Guest Editor Dewi Lewis of Amersham International, contributions from leading international specialists with experience of the application end of the accelerator chain describe their fields of direct interest. The

Special issue - Applying the accelerator

Energy Technology Data Exchange (ETDEWEB)

Anon.

1995-07-15

T'he CERN Courier is the international journal of high energy physics, covering current developments in and around this branch of basic science. A recurrent theme is applying the technology developed for particle accelerators, the machines which produce beams of high energy particles for physics experiments. Twentieth-century science is full of similar examples of applications derived from pure research. This special issue of the CERN Courier is given over to one theme - the applications of accelerators. Accelerator systems and facilities are normally associated with highenergy particle physics research, the search for fundamental particles and the quest to understand the physics of the Big Bang. To the layman, accelerator technology has become synonymous with large and expensive machines, exploiting the most modern technology for basic research. In reality, the range of accelerators and their applications is much broader. A vast number of accelerators, usually much smaller and operating for specific applications, create wealth and directly benefit the population, particularly in the important areas of healthcare, energy and the environment. There are well established applications in diagnostic and therapeutic medicine for research and routine clinical treatments. Accelerators and associated technologies are widely employed by industry for manufacturing and process control. In fundamental and applied research, accelerator systems are frequently used as tools. The biennial conference on the Applications of Accelerators in Industry and Research at Denton, Texas, attracts a thousand participants. This special issue of the CERN Courier includes articles on major applications, reflecting the diversity and value of accelerator technology. Under Guest Editor Dewi Lewis of Amersham International, contributions from leading international specialists with experience of the application end of the accelerator chain describe their fields of direct interest. The contributions

Long term energy-related environmental issues of copper production

Energy Technology Data Exchange (ETDEWEB)

Alvarado, S. [University of Chile, Santiago (Chile). Dept. of Mechanical Engineering; Maldonado, P.; Barrios, A.; Jaques, I. [University of Chile, Santiago (Chile). Energy Research Program

2002-02-01

Primary copper production is a major activity in the mining sector of several countries. However, it is highly energy-intensive and poses important environmental hazards. In the case of Chile, the world's largest copper producer (40% of world total), we examine its energy consumption and energy-related environmental implications over a time horizon of 25 years. Concerning the latter, we focus on greenhouse-gas (GHG) emissions, one of the most debated environmental issues. This paper follows up our previous report in which the current situation was analyzed and a particular technical option for improving the energy efficiency and concurrently reducing GHG emissions was discussed. Estimated reference or base (BS) and mitigation (MS) scenarios are developed for the period ending in 2020. The former assesses the energy demand projected in accordance with production forecasts and specific energy consumption patterns (assuming that energy efficiency measures are adopted 'spontaneously') with their resultant GHG emissions, while the latter assumes induced actions intended to reduce emissions by adopting an aggressive policy of efficient energy use. For the year 2020, the main results are: (i) BS, 1214 t of CO{sub 2}/ton of refined copper content (49% lower than in 1994); (ii) MS, 1037 t of CO{sub 2}/t of refined copper content (56% lower than in 1994). CO{sub 2} emissions have been estimated considering both fuel and electricity process requirements. (author)

Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

Science.gov (United States)

Furlan, Giovanni

2012-08-01

Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically

An Intelligent Improvement of Internet-Wide Scan Engine for Fast Discovery of Vulnerable IoT Devices

Directory of Open Access Journals (Sweden)

Hwankuk Kim

2018-05-01

Full Text Available Since 2016, Mirai and Persirai malware have infected hundreds of thousands of Internet of Things (IoT devices and created a massive IoT botnet, which caused distributed denial of service (DDoS attacks. IoT malware targets vulnerable IoT devices, which are vulnerable to security risks. Techniques are needed to prevent IoT devices from being exploited by attackers. However, unlike high-performance PCs, IoT devices are lightweight, low-power, and low-cost, having performance limitations regarding processing and memory, which makes it difficult to install security and anti-malware programs. Recently, several studies have been attempted to quickly search for vulnerable internet-connected devices to solve this real issue. Issues yet to be studied still exist regarding these types of internet-wide scan technologies, such as filtering by security devices and a shortage of collected operating system (OS information. This paper proposes an intelligent internet-wide scan model that improves IP state scanning with advanced internet protocol (IP randomization, reactive protocol (port scanning, and OS fingerprinting scanning, applying k* algorithm in order to find vulnerable IoT devices. Additionally, we describe the experiment’s results compared to the existing internet-wide scan technologies, such as ZMap and Shodan. As a result, the proposed model experimentally shows improved performance. Although we improved the ZMap, the throughput per minute (TPM performance is similar to ZMap without degrading the IP scan throughput and the performance of generating a single IP address is about 118% better than ZMap. In the protocol scan performance experiments, it is about 129% better than the Censys based ZMap, and the performance of OS fingerprinting is better than ZMap, with about 50% accuracy.

Navigating "Thorny" Issues

Science.gov (United States)

Hutchinson, Kashema; Gilbert, Aderinsola; Malyukova, Anna

2016-01-01

In their article "Mindfulness and discussing 'thorny' issues in the classroom" Konstantinos Alexakos et al. ("Cult Stud Sci Educ," 2016. doi: 10.1007/s11422-015-9718-0) describe "thorny" issues as "difficult topics to discuss because they are more personal to some perhaps even cause pain and violence." As…

Crowdsensing in Smart Cities: Overview, Platforms, and Environment Sensing Issues

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Oscar Alvear

2018-02-01

Full Text Available Evidence shows that Smart Cities are starting to materialise in our lives through the gradual introduction of the Internet of Things (IoT paradigm. In this scope, crowdsensing emerges as a powerful solution to address environmental monitoring, allowing to control air pollution levels in crowded urban areas in a distributed, collaborative, inexpensive and accurate manner. However, even though technology is already available, such environmental sensing devices have not yet reached consumers. In this paper, we present an analysis of candidate technologies for crowdsensing architectures, along with the requirements for empowering users with air monitoring capabilities. Specifically, we start by providing an overview of the most relevant IoT architectures and protocols. Then, we present the general design of an off-the-shelf mobile environmental sensor able to cope with air quality monitoring requirements; we explore different hardware options to develop the desired sensing unit using readily available devices, discussing the main technical issues associated with each option, thereby opening new opportunities in terms of environmental monitoring programs.

Volume 8 Issue 2

Directory of Open Access Journals (Sweden)

Karen Nelson

2017-06-01

Full Text Available This issue is our third Students, Transitions, Achievement, Retention and Success (STARS Conference special issue held in July this year in Adelaide, Australia.   As is customary, this issue of the journal publishes the top research papers selected via a peer review process and the top Emerging Initiatives selected by the Conference Committee.    We are delighted to feature in this special  issue —Reflections on Student Persistence—prepared by Advisory Board member Professor Vincent Tinto, Distinguished University Professor Emeritus at Syracuse University, USA.  Vincent is a long-time friend and supporter of STARS and its predecessor FYHE Conferences and Journal.   In his article, Vincent explores the case for motivation to be considered as a significant aspect of the tertiary student psyche by drawing on theoretical frameworks, research and practical experiences related to the issue.

When Evidence Doesn’t Work (Editorial

Directory of Open Access Journals (Sweden)

Lindsay Glynn

2007-12-01

practice at its finest.So, what happens when evidence doesn’t work? We try to figure out why it didn’t work. Did we miss something in the critical appraisals? What is inherently different in the population or system at hand? Are there other confounders in your environment thatyou had not considered (i.e. time of year, available resources, courses being offered, etc.? As pointed out in this issue’s commentary, a good idea is to plan your project with research and assessment in mind. Not only will you be able to track the various stages of implementation and reactions to it, it will save you the time that you may have taken weeks or months later to retrospectively evaluate. And, never to let an opportunity be wasted, I would welcome an article submission outlining an evidence based implementation that didn’t work. If it doesn’t work, it doesn’t mean that you have failed. It means that there was something you had not anticipated that had a negative effect on your intervention. We can all benefit from such information. Speaking of benefiting, I will take this opportunity to bid a fond farewell to two of EBLIP’s original Editorial Board members: Denise Koufogiannakis and Pam Ryan. Although Denise and Pam have made numerous contributions to evidence based librarianship, their work on this journal has arguably made the biggest footprint. Denise co‐founded this journal and has worked tirelessly to create an avenue for high quality publishing in this subject area. She has passionately maintained the Evidence Summaries for each issue – a task that has required a great deal of both time and expertise. She created an excellent team of writers with whom she works closely and she consistently provides feedback to ensure that first‐rate summaries are published in every issue. Pam courageously agreed to take on the task of Production Editor with the first issue. No one on the Editorial Board had experience with the journal publishing software, OJS, and Pam was able to

Environmental issues and wastes

International Nuclear Information System (INIS)

Mitamura, Hisayoshi; Banba, Tsunetaka; Maeda, Toshikatsu; Ishiyama, Takashi

1999-08-01

All countries in the world are concerned about environmental issues because of their global effects. Developed industrial nations are also confronted with waste issues accompanied by mass production, mass consumption, and mass dump. We have reviewed books and reports to obtain a preliminary knowledge and to understand the trend of technology development before we start R and D for 'environmental monitoring, and environmental remediation and protection'. We lay great emphasis on municipal and industrial wastes in environmental issues and summarize the history of the earth, innovative environmental approaches in advanced nations, waste issues in Japan, and examples of technology development for environmental remediation and protection. (author)

Feasibility of using ultra-high field (7 T MRI for clinical surgical targeting.

Directory of Open Access Journals (Sweden)

Yuval Duchin

Full Text Available The advantages of ultra-high magnetic field (7 Tesla MRI for basic science research and neuroscience applications have proven invaluable. Structural and functional MR images of the human brain acquired at 7 T exhibit rich information content with potential utility for clinical applications. However, (1 substantial increases in susceptibility artifacts, and (2 geometrical distortions at 7 T would be detrimental for stereotactic surgeries such as deep brain stimulation (DBS, which typically use 1.5 T images for surgical planning. Here, we explore whether these issues can be addressed, making feasible the use of 7 T MRI to guide surgical planning. Twelve patients with Parkinson's disease, candidates for DBS, were scanned on a standard clinical 1.5 T MRI and a 7 T MRI scanner. Qualitative and quantitative assessments of global and regional distortion were evaluated based on anatomical landmarks and transformation matrix values. Our analyses show that distances between identical landmarks on 1.5 T vs. 7 T, in the mid-brain region, were less than one voxel, indicating a successful co-registration between the 1.5 T and 7 T images under these specific imaging parameter sets. On regional analysis, the central part of the brain showed minimal distortion, while inferior and frontal areas exhibited larger distortion due to proximity to air-filled cavities. We conclude that 7 T MR images of the central brain regions have comparable distortions to that observed on a 1.5 T MRI, and that clinical applications targeting structures such as the STN, are feasible with information-rich 7 T imaging.

Current issues and actions

Energy Technology Data Exchange (ETDEWEB)

Black, D.G.

1995-06-01

This section of the 1994 Hanford Site Environmental Report summarizes the progress that has been made toward achieving full regulatory compliance at the Hanford Site. Ongoing compliance self-assessments, implementation of the Tri-Party Agreement, and public meetings continue to identify environmental compliance issues. These issues are discussed openly with the regulatory agencies and with the public to ensure that all environmental compliance issues are addressed.

Current issues and actions

International Nuclear Information System (INIS)

Black, D.G.

1995-01-01

This section of the 1994 Hanford Site Environmental Report summarizes the progress that has been made toward achieving full regulatory compliance at the Hanford Site. Ongoing compliance self-assessments, implementation of the Tri-Party Agreement, and public meetings continue to identify environmental compliance issues. These issues are discussed openly with the regulatory agencies and with the public to ensure that all environmental compliance issues are addressed

Data mining for signals in spontaneous reporting databases: proceed with caution.

Science.gov (United States)

Stephenson, Wendy P; Hauben, Manfred

2007-04-01

To provide commentary and points of caution to consider before incorporating data mining as a routine component of any Pharmacovigilance program, and to stimulate further research aimed at better defining the predictive value of these new tools as well as their incremental value as an adjunct to traditional methods of post-marketing surveillance. Commentary includes review of current data mining methodologies employed and their limitations, caveats to consider in the use of spontaneous reporting databases and caution against over-confidence in the results of data mining. Future research should focus on more clearly delineating the limitations of the various quantitative approaches as well as the incremental value that they bring to traditional methods of pharmacovigilance.

NLO QCD corrections to off-shell t anti t and t anti tH at the ILC

International Nuclear Information System (INIS)

Reuter, Juergen; Chokoufe Nejad, Bijan; Weiss, Christian

2017-01-01

We discuss top-quark physics at the ILC with a focus on the full off-shell processes for t anti t and t anti tH production, including top-quark decays and also leptonic W decays. A special focus is on the matching of the resummed vNRQCD threshold calculation and the fixed-order NLO QCD continuum calculation, where we present an update on the validation of the matching. All of the calculations have been performed in the WHIZARD event generator framework.

Genetically modified T cells in cancer therapy: opportunities and challenges

Directory of Open Access Journals (Sweden)

Michaela Sharpe

2015-04-01

Full Text Available Tumours use many strategies to evade the host immune response, including downregulation or weak immunogenicity of target antigens and creation of an immune-suppressive tumour environment. T cells play a key role in cell-mediated immunity and, recently, strategies to genetically modify T cells either through altering the specificity of the T cell receptor (TCR or through introducing antibody-like recognition in chimeric antigen receptors (CARs have made substantial advances. The potential of these approaches has been demonstrated in particular by the successful use of genetically modified T cells to treat B cell haematological malignancies in clinical trials. This clinical success is reflected in the growing number of strategic partnerships in this area that have attracted a high level of investment and involve large pharmaceutical organisations. Although our understanding of the factors that influence the safety and efficacy of these therapies has increased, challenges for bringing genetically modified T-cell immunotherapy to many patients with different tumour types remain. These challenges range from the selection of antigen targets and dealing with regulatory and safety issues to successfully navigating the routes to commercial development. However, the encouraging clinical data, the progress in the scientific understanding of tumour immunology and the improvements in the manufacture of cell products are all advancing the clinical translation of these important cellular immunotherapies.

Editorial, Volume 5, Issue 1

Directory of Open Access Journals (Sweden)

Kristy L. Archuleta

2014-08-01

Full Text Available Welcome to Volume 5, Issue 1 of the Journal of Financial Therapy! In this issue, four scholarly papers are presented along with two profiles and a book review. These four papers address very important issues, such as mental health therapists’ competency in working with financial issues, financial stress of college students, parental messages about money, and financial advice media.

Power Consumption and Calculation Requirement Analysis of AES for WSN IoT.

Science.gov (United States)

Hung, Chung-Wen; Hsu, Wen-Ting

2018-05-23

Because of the ubiquity of Internet of Things (IoT) devices, the power consumption and security of IoT systems have become very important issues. Advanced Encryption Standard (AES) is a block cipher algorithm is commonly used in IoT devices. In this paper, the power consumption and cryptographic calculation requirement for different payload lengths and AES encryption types are analyzed. These types include software-based AES-CB, hardware-based AES-ECB (Electronic Codebook Mode), and hardware-based AES-CCM (Counter with CBC-MAC Mode). The calculation requirement and power consumption for these AES encryption types are measured on the Texas Instruments LAUNCHXL-CC1310 platform. The experimental results show that the hardware-based AES performs better than the software-based AES in terms of power consumption and calculation cycle requirements. In addition, in terms of AES mode selection, the AES-CCM-MIC64 mode may be a better choice if the IoT device is considering security, encryption calculation requirement, and low power consumption at the same time. However, if the IoT device is pursuing lower power and the payload length is generally less than 16 bytes, then AES-ECB could be considered.

Numerical Investigation of Liquid Carryover in T-Junction with Different Diameter Ratios

Science.gov (United States)

Pao, William; Sam, Ban; Saieed, Ahmed; Tran, Cong Minh

2018-03-01

In offshore Malaysia, T-junction is installed at the production header as a compact separator to tap produced gas from reservoir as fuel gas for power generation. However, excessive liquid carryover in T-junction presents a serious operational issue because it trips the whole production platform. The primary objective of present study is to numerically investigate the liquid carryover due to formation of slug, subsequently its liquid carryover at different diameter ratio. The analyses were carried out on a model with 0.0254 m (1 inch) diameter horizontal main arm and a vertically upward side arm using Volume of Fluid Method. Three different sides to main arm diameter ratio of 1.0, 0.5 and 0.3 were investigated with different gas and liquid superficial velocities. The results showed that, while the general trend is true that smaller diameter ratio T-junction has lesser liquid take off capacity, it has a very high frequency of low liquid carryover threshold. In other words, under slug flow, smaller diameter ratio T-junction is constantly transporting liquid even though at a lesser volume in comparison to regular T-junction.

Special issue on the "Consortium for Advanced Simulation of Light Water Reactors Research and Development Progress"

Science.gov (United States)

Turinsky, Paul J.; Martin, William R.

2017-04-01

In this special issue of the Journal of Computational Physics, the research and development completed at the time of manuscript submission by the Consortium for Advanced Simulation of Light Water Reactors (CASL) is presented. CASL is the first of several Energy Innovation Hubs that have been created by the Department of Energy. The Hubs are modeled after the strong scientific management characteristics of the Manhattan Project and AT&T Bell Laboratories, and function as integrated research centers that combine basic and applied research with engineering to accelerate scientific discovery that addresses critical energy issues. Lifetime of a Hub is expected to be five or ten years depending upon performance, with CASL being granted a ten year lifetime.

Bacterial contamination of platelet components not detected by BacT/ALERT®.

Science.gov (United States)

Abela, M A; Fenning, S; Maguire, K A; Morris, K G

2018-02-01

To investigate the possible causes for false negative results in BacT/ALERT ® 3D Signature System despite bacterial contamination of platelet units. The Northern Ireland Blood Transfusion Service (NIBTS) routinely extends platelet component shelf life to 7 days. Components are sampled and screened for bacterial contamination using an automated microbial detection system, the BacT/ALERT ® 3D Signature System. We report on three platelet components with confirmed bacterial contamination, which represent false negative BacT/ALERT ® results and near-miss serious adverse events. NIBTS protocols for risk reduction of bacterial contamination of platelet components are described. The methodology for bacterial detection using BacT/ALERT ® is outlined. Laboratory tests, relevant patient details and relevant follow-up information are analysed. In all three cases, Staphylococcus aureus was isolated from the platelet residue and confirmed on terminal sub-culture using BacT/ALERT ® . In two cases, S. aureus with similar genetic makeup was isolated from the donors. Risk reduction measures for bacterial contamination of platelet components are not always effective. Automated bacterial culture detection does not eliminate the risk of bacterial contamination. Visual inspection of platelet components prior to release, issue and administration remains an important last line of defence. © 2017 British Blood Transfusion Society.

EFECTOS ADVERSOS DERMATOLÓGICOS POR ANTIBACTERIANOS.SISTEMA CUBANO DE FARMACOVIGILANCIA. 2007-2009

Directory of Open Access Journals (Sweden)

Alfonso Orta Ismary

2012-01-01

Full Text Available Introduction: Adverse reactions to antimicrobials in Cuba have taken place since 2003 to date, the first in the report of adverse reactions in general, as well as serious and fatal reactions, on the skin and schedules are the systems more affected. This research aimed to characterize the antibacterial dermatologic toxicities reported by the national coordinating pharmacovigilance unit from 2007 to 2009. Method: An observational study of Pharmacovigilance, descriptive and transversal using Spontaneous Reporting of Suspected Adverse Reaction database and the Cuban system of pharmacovigilance. Reports were analyzed for antibacterial dermatologic toxicities reported from 2007 through 2009, the primary endpoint was the dermatologic adverse effect reported. Results: A total of 3006 suspected adverse reactions to skin. Predominated in females (60.2% and in adults, 53.7%. The antibacterial associated with increased number of notifications were 18.5% RL penicillin, amoxicillin, cephalexin, 17.3% and 9.7%. Dermatological adverse events predominated were rash and urticaria. Moderate adverse effects predominated (64.4%, 87.5% were probable and 81.8% common. Conclusions: Adverse dermatologic antibacterial dominated by females and in adults. RL Penicillin was the drug most associated with adverse reactions. Moderate adverse reactions, probable and common were the more frequent in the study.

"Forest Grove School District v. T.A.": The Supreme Court and Unilateral Private Placements

Science.gov (United States)

Yell, Mitchell L.; Katsiyannis, Antonis; Collins, Terri S.

2010-01-01

On June 22, 2009, the U.S. Supreme Court issued its decision in the case "Forest Grove School District v. T.A." (hereafter "Forest Grove"). In "Forest Grove," the High Court answered the question of whether the parents of students with disabilities are entitled to reimbursement for the costs associated with placing…

Analysis of Right Issue Announcement Effect toward Stock Price Movement and Stock Trading Volume within Issuer in Indonesia Stock Exchange

Directory of Open Access Journals (Sweden)

Wilson Yaputra Yakup

2016-05-01

Full Text Available The purpose of this study were to identify and analyze the rights issue effect to the stock price, the effect of the rights issue on stock trading volume, the correlation between stock prices before and after the right issue, as well as the correlation between volume of trading activity before the right issue and after that event. The objects of the study are the companies listed on Indonesia Stock Exchange (JSX. The hypothesis stated that right issues have a significant effect on stock price on companies listed on the JSX, rights issues have a significant effect on the stock trading volume on companies listed on the JSX, there is a significant correlation between stock price before and after the rights issue on companies listed in JSX, there is a significant correlation between volume of the stock trading before the rights issue and after that event. Data analysis used were descriptive statistics, simple linear regression analysis and paired t-test. Hypothesis testing was performed by using the Pearson correlation test with significance level of 5%. The results show that the right issue has a positive effect but not significant toward stock prices of companies listed in JSX, right issue has a negative effect and not significant toward the trading volume activity (TVA on companies listed in JSX.

Investigation of V and V process for thermal fatigue issue in a sodium cooled fast reactor – Application of uncertainty quantification scheme in verification and validation with fluid-structure thermal interaction problem in T-junction piping system

Energy Technology Data Exchange (ETDEWEB)

Tanaka, Masaaki, E-mail: tanaka.masaaki@jaea.go.jp

2014-11-15

Highlights: • Outline of numerical simulation code MUGTHES for fluid-structure thermal interaction was described. • The grid convergence index (GCI) method was applied according to the ASME V and V-20 guide. • Uncertainty of MUGTHES can be successfully quantified for thermal-hydraulic problems and unsteady heat conduction problems in the structure. • Validation for fluid-structure thermal interaction problem in a T-junction piping system was well conducted. - Abstract: Thermal fatigue caused by thermal mixing phenomena is one of the most important issues in design and safety assessment of fast breeder reactors. A numerical simulation code MUGTHES consisting of two calculation modules for unsteady thermal-hydraulics analysis and unsteady heat conduction analysis in structure has been developed to predict thermal mixing phenomena and to estimate thermal response of structure under the thermal interaction between fluid and structure fields. Although verification and validation (V and V) of MUGTHES has been required, actual procedure for uncertainty quantification is not fixed yet. In order to specify an actual procedure of V and V, uncertainty quantifications with the grid convergence index (GCI) estimation according to the existing guidelines were conducted in fundamental laminar flow problems for the thermal-hydraulics analysis module, and also uncertainty for the structure heat conduction analysis module and conjugate heat transfer model was quantified in comparison with the theoretical solutions of unsteady heat conduction problems. After the verification, MUGTHES was validated for a practical fluid-structure thermal interaction problem in T-junction piping system compared with measured results of velocity and temperatures of fluid and structure. Through the numerical simulations in the verification and validation, uncertainty of the code was successfully estimated and applicability of the code to the thermal fatigue issue was confirmed.

T1 and T2 relaxivity of intracellular and extracellular USPIO at 1.5T and 3T clinical MR scanning

International Nuclear Information System (INIS)

Simon, Gerhard H.; Bauer, Jan; Saborovski, Olaf; Fu, Yanjun; Wendland, Michael F.; Daldrup-Link, Heike E.; Corot, Claire

2006-01-01

In this study we evaluated the effects of intracellular compartmentalization of the ultrasmall superparamagnetic iron oxide (USPIO) ferumoxtran-10 on its proton T1 and T2 relaxivities at 1.5 and 3T. Monocytes were labeled with ferumoxtran-10 by simple incubation. Decreasing quantities of ferumoxtran-10-labeled cells (2.5 x 10 7 -0.3 x 10 7 cells/ml) and decreasing concentrations of free ferumoxtran-10 (without cells) in Ficoll solution were evaluated with 1.5 and 3T clinical magnetic resonance (MR) scanners. Pulse sequences comprised axial spin echo (SE) sequences with multiple TRs and fixed TE and SE sequences with fixed TR and increasing TEs. Signal intensity measurements were used to calculate T1 and T2 relaxation times of all samples, assuming a monoexponential signal decay. The iron content in all samples was determined by inductively coupled plasma atomic emission spectrometry and used for calculating relaxivities. Measurements at 1.5T and 3T showed higher T1 and T2 relaxivity values of free extracellular ferumoxtran-10 as opposed to intracellularly compartmentalized ferumoxtran-10, under the evaluated conditions of homogeneously dispersed contrast agents/cells in Ficoll solution and a cell density of up to 2.5 x 10 7 cells/ml. At 3T, differences in T1-relaxivities between intra- and extracellular USPIO were smaller, while differences in USPIO T2-relaxivities were similar compared with 1.5T. In conclusion, cellular compartmentalization of ferumoxtran-10 changes proton relaxivity. (orig.)