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Sample records for french pharmacovigilance database

  1. [Drugs and retinal disorders: A case/non-case study in the French pharmacovigilance database].

    PubMed

    Bourgeois, Nicolas; Chavant, François; Lafay-Chebassier, Claire; Leveziel, Nicolas; Pérault-Pochat, Marie-Christine

    2016-09-01

    Retina is the part of the eye suffering most damage from pharmaceutical molecules. Drug-induced retinopathies have been described but data are scarce and sometimes conflicting especially concerning its potential seriousness. The aim of this study was to investigate potential associations between drugs and retinal disorders using the French Pharmacovigilance data. We used the case/non-case method in the French PharmacoVigilance Database (FPVD) to identify drugs able to induce retinopathies. Cases were reports of retinal disorders in the FPVD between January 2008 and December 2012. Non-cases were all other reports during the same period. To assess the association between retinopathy and drug intake, we calculated the odds-ratio (OR) [with their 95% confidence intervals] for all drugs associated with at least 3 cases of retinopathy. Among the 123 687 adverse drug reactions recorded during the studied period, we identified 164 cases of retinal disorders. Significant associations were found for 11 drugs. The main therapeutic classes were antirhumatismals (hydroxychloroquine, chloroquine and etanercept: 18 cases), anti-infective (ribavirine, PEG-interferon-alfa-2a and cefuroxime: 16 cases) and antineoplastic drugs (imatinib and letrozole: 8 cases. Three other drugs were also found: raloxifene (5 cases), erythropoietin beta (4 cases) and ranibizumab (3 cases). Taking into account the limits of the methodology, our study confirmed the association between retinopathy and some expected drugs such as aminoquinolines, interferons, imatinib or ranibizumab. Other drugs like erythropoietin beta, cefuroxime, letrozole and etanercept were significantly associated with retinal disorders although this was not or poorly described in the literature. Thus, further prospective studies are necessary to confirm such associations.

  2. Drug-induced progressive multifocal leukoencephalopathy: a case/noncase study in the French pharmacovigilance database.

    PubMed

    Colin, Olivier; Favrelière, Sylvie; Quillet, Alexandre; Neau, Jean-Philippe; Houeto, Jean-Luc; Lafay-Chebassier, Claire; Pérault-Pochat, Marie-Christine

    2017-04-01

    Progressive multifocal leukoencephalopathy (PML) is an often fatal demyelinating disease of the central nervous system. As effective treatment is unavailable, identification of all drugs that could be associated with PML is essential. The objective of this study was to investigate the putative association of reports of PML and drugs. We used the case/noncase method in the French PharmacoVigilance database (FPVD). Cases were reports of PML in the FPVD between January 2008 and December 2015. Noncases were all other reports during the same period. To assess the association between PML and drug intake, we calculated an adverse drug report odds ratio (ROR) with its 95% confidence interval. We have studied the delay of onset of PML for each drug concerned. Among the 101 cases of PML, 39 drugs were mentioned as suspect. The main therapeutic classes suspected with significant ROR were antineoplastic agents (n = 85), immunosuppressants (n = 67), and corticosteroids. A latent interval from the time of drug initiation to the development of PML is established: the median time to onset was 365 days (123-1095 days). The onset of PML is highly variable and differs among drug classes [from 1 to 96 months (IQR: 39.0-126)]. An association between PML and some immunosuppressant drugs was found as expected, but also with antineoplastic agents and glucocorticoids. An important delay of PML onset after stopping treatment is suspected and should alert prescribers. Prescribers but also patients should be informed about the potential associations with all these drugs. Monitoring could be necessary for many drugs to early detect PML.

  3. Drug-induced Depression: a Case/Non Case Study in the French Pharmacovigilance Database.

    PubMed

    Lafay-Chebassier, Claire; Chavant, François; Favrelière, Sylvie; Pizzoglio, Véronique; Pérault-Pochat, Marie-Christine

    2015-01-01

    Depression is a complex disorder with heterogeneous clinical anomalies whose neurobiological understanding still remains unclear. Medications have been implicated as potential causes of depression but for many of them, data are controversial. The present study aims to investigate association bet ween drugs and reports of depression. We used the case/non case method in the French pharmacovigilance database (FPVD) to identify drugs associated with depression. Cases were reports of depression in the FPVD between January 2007 and December 2011. Non cases were all other reports during the same period. Data were expressed as reporting odds ratio (ROR) with their 95% confidence interval. Of the 114,692 reports recorded in the FPVD during the studied period, we identified 474 cases of depression. For the majority of the patients, they were considered as "non serious" (56%) and evolution was favorable (64%). Significant RORs were found for antiepileptics (topiramate, levetiracetam), anti-infective and especially anti-retroviral drugs (efavirenz, emtricitabine, tenofovir, etravirine, raltegravir), interferons and other agents including isotretinoin, methylphenidate, sodium oxybate, varenicline, montelukast, flunarizine, adalimumab, anastrozole. Taking into account the limits of the methodology, the present study described associations with mainly expected drugs belonging to various therapeutic classes but it also found a signal with some anti-retrovirals. On the contrary, we did not find some assumed associations like cardiovascular medications, antimalarial. For most of the drugs, one or more mechanisms were found to explain these depressogenic effects on the basis of animal and human literature. Even if such associations need to be confirmed by further prospective studies, cautions are necessary for many drugs to early detect depressive symptoms.

  4. French pharmacovigilance: Missions, organization and perspectives.

    PubMed

    Vial, Thierry

    2016-04-01

    Pharmacovigilance aims to identify unknown adverse drug reactions once clinical development is complete, in order to promote improved use of drugs, and thus a reduction in risk for every exposed patient. We describe in this article the missions of French pharmacovigilance system, including French drug agency, Regional Centers of Pharmacovigilance, health professionals, pharmaceutical companies, patients and their associations. We also develop the French pharmacovigilance organization, its perspectives and challenges, both in French and European levels.

  5. Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database

    PubMed Central

    2011-01-01

    Background Thiazolidinediones (TZDs), rosiglitazone (RGZ) and pioglitazone (PGZ) are widely used as hypoglycemic drugs in patients with type 2 diabetes mellitus. The aim of our study was to investigate the profile of adverse drug reactions (ADRs) related to TZDs and to investigate potential risk factors of these ADRs. Methods Type 2 diabetic patients were identified from the French Database of PharmacoVigilance (FPVD) between 2002 and 2006. We investigated ADR related to TZD, focusing on 4 ADR: edema, heart failure, myocardial infarction and hepatitis corresponding to specific WHO-ART terms. Results Among a total of 99,284 adult patients in the FPVD, 2295 reports concerned type 2 diabetic patients (2.3% of the whole database), with 161 (7%) exposed to TZDs. The frequency of edema and cardiac failure was significantly higher with TZDs than in other patients (18% and 7.4% versus 0.8% and 0.1% respectively, p < 0.001) whereas the frequency of hepatitis was similar (5.9% versus 4%, NS). A multiple logistic regression model taking into account potential confounding factors (age, gender, drug exposure and co-morbidities) found that TZD exposure remained associated with heart failure and edema, but not with hepatitis or myocardial infarction. Conclusions Thiazolidinediones exposure is associated with an increased risk of edema and heart failure in patients with type 2 diabetes even when recommendations for use are respected. In contrast, the risk of hepatic reactions and myocardial infarction with this class of drugs seems to be similar to other hypoglycemic agents. PMID:21609444

  6. Drug interactions between antihypertensive drugs and non-steroidal anti-inflammatory agents: a descriptive study using the French Pharmacovigilance database.

    PubMed

    Fournier, Jean-Pascal; Sommet, Agnès; Durrieu, Geneviève; Poutrain, Jean-Christophe; Lapeyre-Mestre, Maryse; Montastruc, Jean-Louis

    2014-04-01

    Drug-drug interactions (DDIs) between antihypertensive drugs and non-steroidal anti-inflammatory drugs (NSAIDs) can lead to adverse drug reactions (ADRs). Guidelines are available to help prescribers deal with these drug associations, but their implementation is not well evaluated. The aims of this study were to assess the prevalence of NSAIDs exposure in patients treated with antihypertensive drugs, using the French Pharmacovigilance database, and explore the ADRs related to DDIs between antihypertensive drugs and NSAIDs. Over the 11, 442 notifications of ADRs recorded in this database in patients treated with oral antihypertensive drugs between 2008 and 2010, 517 (4.5 and 95% CI: 4.1-4.9) also included exposure to NSAIDs. These subjects were more frequently women, took more drugs in general, and were younger and less frequently treated with antiplatelet drugs. In 24.2% of them (125 patients), a DDI between NSAIDs and antihypertensive drugs was potentially the cause of the reported ADR. Acute renal failure caused by DDIs between NSAIDs and angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), or diuretics was the most frequently reported ADR (20.7%). Finally, in the French Pharmacovigilance database, around one-fourth of associations NSAIDs  +  antihypertensive drugs are associated with a 'serious' ADR (mainly acute renal failure), suggesting that this well-known DDI is not enough taken into account by prescribers.

  7. More on the "Triple Whammy": antihypertensive drugs, non-steroidal anti-inflammatory agents and acute kidney injury - a case/non-case study in the French pharmacovigilance database.

    PubMed

    Fournier, Jean-Pascal; Sommet, Agnès; Durrieu, Geneviève; Poutrain, Jean-Christophe; Lapeyre-Mestre, Maryse; Montastruc, Jean-Louis

    2014-08-01

    It has been suggested that the risk of acute kidney injury (AKI) increases with the number of drugs associated between non-steroidal anti-inflammatory drugs (NSAIDs), angiotensin converting enzyme inhibitors (ACEis) [or angiotensin receptor blockers (ARBs)] and diuretics. We aimed to investigate whether the number of drugs associated between NSAIDs, ACEis, ARBs and diuretics was associated to disproportionate reporting of AKI in the French Pharmacovigilance Database. In reports of Adverse Drug Reactions (ADRs) recorded between 01 January 2008 and 31 December 2010, we selected patients whose medications included at least one oral antihypertensive drug. We used a case/non-case methodology. Cases were AKI and non-cases were all the remaining reports. Among the 11,442 ADR reports in patients under antihypertensive drug recorded in the French Pharmacovigilance Database, 837 ADRs were AKI (7.3%, 95% CI 6.8-7.8). AKI and the number of drugs associated were disproportionately reported (one drug alone: adjusted ROR 2.19, 95% CI: 1.65-2.89, two drugs: adjusted ROR 5.27, 95% CI: 4.00-6.94, three and more: adjusted ROR 16.46, 95% CI: 11.38-23.80). There was no significant association between NSAIDs' half-lives and reporting of AKI (adjusted ROR=0.54, 95% CI: 0.25-1.15). Given the widespread use of these hazardous drugs in general population, caution is needed when they are associated.

  8. Safety profile of etifoxine: A French pharmacovigilance survey.

    PubMed

    Cottin, Judith; Gouraud, Aurore; Jean-Pastor, Marie-Josèphe; Dautriche, Anne Disson-; Boulay, Charlène; Geniaux, Hélène; Auffret, Marine; Bernard, Nathalie; Descotes, Jacques; Vial, Thierry

    2016-04-01

    Etifoxine chlorhydrate is a benzoxazine derivative approved for the treatment of psychosomatic manifestations of anxiety since 1979. Previously labeled adverse drug reactions (ADRs) only include drowsiness, benign cutaneous reactions, and acute hypersensitivity reactions. The objectives were to examine recent data on etifoxine-related ADR by reviewing Individual Case Safety Reports (ICSRs) recorded in France especially unexpected ADRs. Etifoxine-related ICSRs were extracted from the French Pharmacovigilance database from 1 January 2000 to 30 April 2012 and data from the marketing authorization holder up to 31 December 2011 were also obtained. Of the 350 cases retained for analysis, 123 (35%) were considered serious. Dermatological or acute hypersensitivity reactions were the most frequent ADRs (59%) mainly isolated cutaneous eruptions. However, there were 24 cases of severe toxidermia (DRESS in 5, erythema multiforme in 10 and Stevens-Johnson syndrome in 5) with etifoxine as the most suspected drug in 11 patients, and seven cases of vasculitis or serum sickness-like reaction. Liver disorders were reported in 34 patients of whom 25 developed acute hepatitis with a cytolytic biological pattern in 16. Other unexpected ADRs included 16 reversible cases of metrorrhagia with positive rechallenge in 5, and three cases of biopsy-proven microscopic colitis of which one recurred after etifoxine re-administration. Although etifoxine has been marketed for more than 30 years, this survey identified a number of unexpected and sometimes serious ADRs, in particularly severe toxidermia and acute cytolytic hepatitis. A recent update of the French etifoxine summary of the product characteristics (SPC) was based on these findings.

  9. Causality assessment in pharmacovigilance: The French method and its successive updates.

    PubMed

    Miremont-Salamé, Ghada; Théophile, Hélène; Haramburu, Françoise; Bégaud, Bernard

    2016-04-01

    The methods for causality assessment of adverse drug reactions were developed in the 1970s and 1980s, alongside the development of pharmacovigilance. The French method is one of the earlier of these, following on from the pioneering works by Irey and Karch and Lasagna. Initially published in 1978, it was updated in 1985, and again in 2011. The main alterations to the original method are presented in tables annexed to this paper. The successive versions improved the presentation, provided more formalised definitions of the criteria for assessing causality, while at the same time ensuring the method remained easy to use. Causality assessment enables the causal link between a drug and the occurrence of an adverse reaction to be formalised and explained. It contributes to diagnosis, and to determining the action to be taken in case of an adverse drug reaction. It can contribute to the quality and the relevance of the data stored in pharmacovigilance databases.

  10. [Nalmefene and Opioid Withdrawal Syndrome: Analysis of the Global Pharmacovigilance Database for Adverse Drug Reactions].

    PubMed

    Dahmke, Hendrike; Kupferschmidt, Hugo; Kullak-Ublick, Gerd A; Weiler, Stefan

    2015-10-14

    Nalmefene (Selincro®) is a selective opioid receptor antagonist, licensed in April 2014 in Switzerland for the reduction of alcohol consumption in adults with a high drinking risk level. 200 reports of adverse drug reactions of nalmefene have been documented worldwide in the WHO global pharmacovigilance database between 7th March 1997 to 1st March 2015. In 21 cases (10,5%) nalmefene and an opioid were administered concomitantly, causing withdrawal symptoms. Until now, the regional pharmacovigilance center in Zurich received four cases of nalmefene combined with opioids. This combination should be avoided.

  11. [The congress of the French Society of Pharmacology and Therapeutics celebrate in Nancy, 20 April 2016, 40 years of French Regional Pharmacovigilance Centres!].

    PubMed

    Jonville-Béra, Annie-Pierre; Mallaret, Michel; Sgro, Catherine

    2016-09-01

    In 1976, the Regional Pharmacovigilance Centres were created in France to collect and analyze adverse drug reactions. Even if they have, to date, managed and transmitted more than 583,000 adverse drug reactions to the French and international health authorities, the missions of these university hospital structures supervised by clinical pharmacologists are not limited to this activity. They also provide a consulting and diagnostic aid for drug diseases. Their other main mission is information about drugs and their proper use for health professionals and patients on any matter relating to medicines. These queries are used to adjust and focus the training of health professionals in prevention of drug risks and improvement of drug use. Beside signal detection and identification of alerts, the 31 Regional Pharmacovigilance Centres collaborate with the French Drug Agency (Agence nationale de sécurité du medicament et des produits de santé [ANSM]) by achieving expertise on drugs and participation in various working groups and committees. Finally, Regional Pharmacovigilance Centres participate in scientific advancement through research and publication activities.

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

    PubMed

    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.

  13. Lexique 2: a new French lexical database.

    PubMed

    New, Boris; Pallier, Christophe; Brysbaert, Marc; Ferrand, Ludovic

    2004-08-01

    In this article, we present a new lexical database for French: Lexique. In addition to classical word information such as gender, number, and grammatical category, Lexique includes a series of interesting new characteristics. First, word frequencies are based on two cues: a contemporary corpus of texts and the number of Web pages containing the word. Second, the database is split into a graphemic table with all the relevant frequencies, a table structured around lemmas (particularly interesting for the study of the inflectional family), and a table about surface frequency cues. Third, Lexique is distributed under a GNU-like license, allowing people to contribute to it. Finally, a metasearch engine, Open Lexique, has been developed so that new databases can be added very easily to the existing ones. Lexique can either be downloaded or interrogated freely from http://www.lexique.org.

  14. Hepatotoxicity related to agomelatine and other new antidepressants: a case/noncase approach with information from the Portuguese, French, Spanish, and Italian pharmacovigilance systems.

    PubMed

    Montastruc, François; Scotto, Stefania; Vaz, Ines Ribeiro; Guerra, Leonor Nogueira; Escudero, Antonio; Sáinz, María; Falomir, Teresa; Bagheri, Haleh; Herdeiro, Maria Teresa; Venegoni, Mauro; Montastruc, Jean Louis; Carvajal, Alfonso

    2014-06-01

    Antidepressants have been associated with a low incidence of idiosyncratic hepatic injury. Some of them, nefazodone or amineptine, were observed to induce severe hepatic injury and withdrawn from the market. Recently, some cases of this severe condition have been reported in association with agomelatine use. Therefore, the objective of this study is to learn the risk of hepatic damage with agomelatine as compared with other new antidepressants. We took data from the Spanish, French, Italian, and Portuguese pharmacovigilance system databases. A case/noncase approach to assess the strength of the association between whichever antidepressant and hepatotoxicity was performed; cases were defined as reports of hepatotoxicity; noncases were reports of all reactions other than hepatotoxicity. Exposure was the recording of a new antidepressant in a report, whether or not it was suspected of causing the reaction. During the period surveyed, 3300 cases of hepatotoxicity were collected for the antidepressants assessed. They represent 10.3% of all cases collected for these drugs; the corresponding figure for all drugs was 6.0%. Meanwhile, 63 cases of hepatotoxicity associated with agomelatine were collected since its introduction until the end of the period studied; they account for a percentage of 14.6. Agomelatine was statistically associated with hepatotoxicity in Spain [reporting odds ratio (ROR), 4.9 (95% confidence interval [CI], 2.4-9.7)], France (ROR, 2.4 [95% CI, 1.5-3.7]), and Italy (ROR, 5.1 [95% CI, 1.7-14.0]). Current results support the idea of agomelatine to be related to a higher hepatotoxicity risk. Physicians should consider early discontinuation if the condition is suspected; health authorities should promptly explore the best regulatory actions to be taken.

  15. Adverse drug reactions to self-medication: a study in a pharmacovigilance database.

    PubMed

    Berreni, Aurélia; Montastruc, François; Bondon-Guitton, Emmanuelle; Rousseau, Vanessa; Abadie, Delphine; Durrieu, Geneviève; Chebane, Leila; Giroud, Jean-Paul; Bagheri, Haleh; Montastruc, Jean-Louis

    2015-10-01

    Although self-medication is widely developed, there are few detailed data about its adverse drug reactions (ADRs). This study investigated the main characteristics of ADRs with self-medication recorded in the Midi-Pyrénées PharmacoVigilance between 2008 and 2014. Self-medication included first OTC drugs and second formerly prescribed drugs later used without medical advice (reuse of previously prescribed drugs). Among the 12 365 notifications recorded, 160 (1.3%) were related to SM with 186 drugs. Around three-forth of the ADRs were 'serious'. Mean age was 48.8 years with 56.3% females. The most frequent ADRs were gastrointestinal and neuropsychiatric and main drug classes involved NSAIDs, analgesics, and benzodiazepines. Phytotherapy-homeopathy accounted for 9.1% of drugs.

  16. Cyberpharmacovigilance: What is the usefulness of the social networks in pharmacovigilance?

    PubMed

    Bagheri, Haleh; Lacroix, Isabelle; Guitton, Emmanuelle; Damase-Michel, Christine; Montastruc, Jean-Louis

    2016-04-01

    Internet is changing the way people learn about health and illness. Health websites are among the most popular resources on the web. The sharing of patient experiences on a website could be an interesting source of information about adverse drug reactions (ADRs) or could generate "signals". Three examples of the use of patient forums in pharmacovigilance are discussed: (1) analysis of perceptions of risk by patients before and after withdrawal of benfluorex, and then following media coverage; (2) comparison of oral antineoplasic-induced ADRs collected on patient websites with those registered in the French pharmacovigilance database; (3) analysis of data found in the social media about drugs and pregnancy.

  17. Application of Pharmacovigilance Methods in Occupational Health Surveillance: Comparison of Seven Disproportionality Metrics

    PubMed Central

    Bicout, Dominique Joseph; de Gaudemaris, Regis

    2012-01-01

    Objectives The French National Occupational Diseases Surveillance and Prevention Network (RNV3P) is a French network of occupational disease specialists, which collects, in standardised coded reports, all cases where a physician of any specialty, referred a patient to a university occupational disease centre, to establish the relation between the disease observed and occupational exposures, independently of statutory considerations related to compensation. The objective is to compare the relevance of disproportionality measures, widely used in pharmacovigilance, for the detection of potentially new disease × exposure associations in RNV3P database (by analogy with the detection of potentially new health event × drug associations in the spontaneous reporting databases from pharmacovigilance). Methods 2001-2009 data from RNV3P are used (81,132 observations leading to 11,627 disease × exposure associations). The structure of RNV3P database is compared with the ones of pharmacovigilance databases. Seven disproportionality metrics are tested and their results, notably in terms of ranking the disease × exposure associations, are compared. Results RNV3P and pharmacovigilance databases showed similar structure. Frequentist methods (proportional reporting ratio [PRR], reporting odds ratio [ROR]) and a Bayesian one (known as BCPNN for "Bayesian Confidence Propagation Neural Network") show a rather similar behaviour on our data, conversely to other methods (as Poisson). Finally the PRR method was chosen, because more complex methods did not show a greater value with the RNV3P data. Accordingly, a procedure for detecting signals with PRR method, automatic triage for exclusion of associations already known, and then investigating these signals is suggested. Conclusion This procedure may be seen as a first step of hypothesis generation before launching epidemiological and/or experimental studies. PMID:22993712

  18. Tumor necrosis factor inhibitors added to nonbiological immunosuppressants vs. nonbiological immunosuppressants alone: a different signal of cancer risk according to the condition. A disproportionality analysis in a nationwide pharmacovigilance database.

    PubMed

    Saliba, Layla; Moulis, Guillaume; Abou Taam, Malak; Rousseau, Vanessa; Chebane, Leila; Petitpain, Nadine; Baldin, Bernadette; Pugnet, Grégory; Montastruc, Jean-Louis; Bagheri, Haleh

    2016-04-01

    We aimed at detecting a signal of an increased risk of cancer in patients treated with TNF inhibitor (TNFi) and nonbiological immunosuppressant (NBIS), compared with NBIS alone for autoimmune diseases. Secondly, we aimed at comparing this risk between the different TNFis. We conducted a disproportionality analysis (case/noncase study) from the French National PharmacoVigilance Database. We selected all the reports of serious adverse drug reactions from 2000 to 2010 in patients treated with NBIS for labeled indications of TNFi. Cases were all the reports of cancer that occurred after a minimal 3-month exposure to NBIS. Noncases were all the other reports. We searched for exposure to TNFi and calculated reporting odds ratios (RORs), stratified by condition and type of cancer and adjusted by age, gender, history of cancer, type of NBIS and year of reporting. Of the 1918 reports included in the study population, 217 were cases (135 solid and 82 blood cancers). A safety signal was found in rheumatoid arthritis (RA) (ROR: 5.43, 95% CI[3.52-8.38]) particularly for nonmelanoma skin cancer (NMSC) (20.17[2.49-163.36]), and in psoriasis/psoriatic arthritis (3.45[1.09-10.92]). No signal was found in inflammatory bowel diseases (IBD) and ankylosing spondylitis, whatever the type of cancer. There was no difference between TNFis. This study puts the argument of an increased risk of cancer (particularly NMSC) in patients with rheumatoid arthritis exposed to TNFi and NBIS compared with NBIS alone, but not in IBD and ankylosing spondylitis patients. No signal was detected for melanoma potentially related to the lack of power. The signal seems similar whatever the TNFi.

  19. Comparison of two drug safety signals in a pharmacovigilance data mining framework.

    PubMed

    Tubert-Bitter, Pascale; Bégaud, Bernard; Ahmed, Ismaïl

    2016-04-01

    Since adverse drug reactions are a major public health concern, early detection of drug safety signals has become a top priority for regulatory agencies and the pharmaceutical industry. Quantitative methods for analyzing spontaneous reporting material recorded in pharmacovigilance databases through data mining have been proposed in the last decades and are increasingly used to flag potential safety problems. While automated data mining is motivated by the usually huge size of pharmacovigilance databases, it does not systematically produce relevant alerts. Moreover, each detected signal requires appropriate assessment that may involve investigation of the whole therapeutic class. The goal of this article is to provide a methodology for comparing two detected signals. It is nested within the automated surveillance framework as (1) no extra information is required and (2) no simple inference on the actual risks can be extrapolated from spontaneous reporting data. We designed our methodology on the basis of two classical methods used for automated signal detection: the Bayesian Gamma Poisson Shrinker and the frequentist Proportional Reporting Ratio. A simulation study was conducted to assess the performances of both proposed methods. The latter were used to compare cardiovascular signals for two HIV treatments from the French pharmacovigilance database.

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

    PubMed Central

    Fujiwara, Masakazu; Kawasaki, Yohei; Yamada, Hiroshi

    2016-01-01

    Background 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. Methods and Findings 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. Conclusions Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported

  1. The role of data mining in pharmacovigilance.

    PubMed

    Hauben, Manfred; Madigan, David; Gerrits, Charles M; Walsh, Louisa; Van Puijenbroek, Eugene P

    2005-09-01

    A principle concern of pharmacovigilance is the timely detection of adverse drug reactions that are novel by virtue of their clinical nature, severity and/or frequency. The cornerstone of this process is the scientific acumen of the pharmacovigilance domain expert. There is understandably an interest in developing database screening tools to assist human reviewers in identifying associations worthy of further investigation (i.e., signals) embedded within a database consisting largely of background 'noise' containing reports of no substantial public health significance. Data mining algorithms are, therefore, being developed, tested and/or used by health authorities, pharmaceutical companies and academic researchers. After a focused review of postapproval drug safety signal detection, the authors explain how the currently used algorithms work and address key questions related to their validation, comparative performance, deployment in naturalistic pharmacovigilance settings, limitations and potential for misuse. Suggestions for further research and development are offered.

  2. Forensic pharmacovigilance: Newer dimension of pharmacovigilance.

    PubMed

    Sewal, Rakesh K; Saini, Vikas K; Medhi, Bikash

    2015-08-01

    Drug safety for the patients is of paramount importance for a medical professional. Pharmacovigilance attempts to ensure the safety of patients by keeping a close vigil on the pattern of adverse events secondary to drug use. Number of medicolegal cases is at rise since last few years. Forensic sciences and pharmacovigilance need to work hand in hand to unlock the mystery of many criminal and civil proceedings. Pharmacovigilance offers its wide scope in forensic sciences by putting forward its expertise on adverse profile of drugs which may be instrumental in solving the cases and bringing the justice forth. It may range from as simple affairs as defining the adverse drug reaction on one hand to putting expert advice in critical criminal cases on the other one. Pharmacovigilance experts have to abide by the ethics of the practice while executing their duties as expert else it may tarnish the justice and loosen its dependability. As a budding discipline of science, it is confronted with several hurdles and challenges which include reluctance of medical professionals for being involved in court proceedings, extrapolations of facts and data and variations in law across the globe etc. These challenges and hurdles call the medical fraternity come forward to work towards the momentous application of pharmacovigilance in the forensic sciences. Evidence based practice e.g. testing the biological samples for the presence of drugs may prove to be pivotal in the success of this collaboration of sciences.

  3. [Pharmacovigilance of major parmaceutical innovation].

    PubMed

    Xiang, Yongyang; Xie, Yanming; Yi, Danhui

    2011-10-01

    With the continuous improvement of international "pharmacovigilance" technology and methods,it becomes the key part of the post-marketing evaluation. This issue is based on this research background, and also means to find out the Chinese medicine safety monitor which consistents with the reality. A common problem is that those who choose a career in pharmacovigilance know how the complex data presented to us are a source of both fascination and frustration. In the 70's, for the first time data mining technology in the international pharmacovigilance turn up, we try to establish new signal detection method to make contributes to post-marketing evaluation of Chinese medicine and establishment of registration. Building the national adverse reaction reporting database is widely used in western country. Nature of the problem is that pharmacovigilance issues can come through a lot of assumptions into the statistical problems, different assumptions are for different statistical tests. Through the traditional imbalance between the proportion of fourfold table for other assumptions, few countries use in practice, this does not involve evidence, but this issue provides the introduce of the principle. Methods include the ratio of the report of the Netherlands (ROR), the proportion of reports than the UK ratio (PRR),WHO's information points (IC), the U.S. Food and Drug Administration empirical Bayes (EBS), etc. Because there is no international gold standard of the signal detection method, at first we use the simulation comparing these four methods of data mining, From the point of specificity, the sample size demand, this issue views the advantages and disadvantages of four methods and application conditions,and from a technical point of view and try to propose a new signal detection method, for example, Hierarchical Bayesian.

  4. The reorganisation of European pharmacovigilance. Part 2. From spontaneous reports to agency reviews and decisions.

    PubMed

    2015-02-01

    Despite the fact that adverse effects are vastly under-reported, spontaneous reporting remains the foundation of pharmacovigilance. A small series of properly documented cases, when very specific, can suffice to constitute a signal. In France, reporting adverse effects to Regional Pharmacovigilance Centres (CRPVs) permits high-quality analysis of pharmacovigilance signals, so that they can be brought to the attention of the national agency responsible for making decisions about drugs, the French Health Products Agency (ANSM). The ANSM can use this information to protect patients by implementing the measures within its power or by initiating a European referral. When a decision taken at the national level concerns a drug marketed in several Member States of the European Union, a "harmonisation" procedure results in a decision taken at community level, applicable in all Member States. This means that a safety issue raised by a single Member State sometimes leads to a decision that protects the population of the entire European Union. But it also means that other European decisions can compel national agencies to allow back onto the market a drug that they sought to withdraw in order to protect their citizens. Negotiations with other Member States, the European Medicines Agency (EMA) and the European Commission must be supported by robust data: this is yet another reason for each country to have its own effective national pharmacovigilance database, the contents of which should be publicly accessible. This is unfortunately not yet the case in France in 2014. It also provides another good reason for healthcare professionals and patients to report adverse effects, so that the details can be recorded in national and European databases.

  5. Pharmacovigilance in Asia

    PubMed Central

    Biswas, Pipasha

    2013-01-01

    An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the bar by various stakeholders more importantly by the regulatory authorities. The number of Adverse Drug Reactions (ADRs) reported have also resulted in an increase in the volume of data handled and to understand pharmacovigilance a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Proactive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety in Asia. It has been a constant challenge to standardize pharmacovigilance in Asia, in the context of clinical trials and post-marketing pharmacovigilance due to varied geaographical, cultural and medical practices in these regioon. While major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in Asian countries, though several attempts have been taken. However, with more clinical trials and clinical research activity being conducted in the Asian continent, there is an immense need to understand and implement pharmacovigilance. For this to happen, the mind set of people working in regulatory agencies, the Pharmaceutical companies, prescribers and patients/consumers need to change. PMID:24347987

  6. Pharmacovigilance in Asia.

    PubMed

    Biswas, Pipasha

    2013-12-01

    An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the bar by various stakeholders more importantly by the regulatory authorities. The number of Adverse Drug Reactions (ADRs) reported have also resulted in an increase in the volume of data handled and to understand pharmacovigilance a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Proactive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety in Asia. It has been a constant challenge to standardize pharmacovigilance in Asia, in the context of clinical trials and post-marketing pharmacovigilance due to varied geaographical, cultural and medical practices in these regioon. While major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in Asian countries, though several attempts have been taken. However, with more clinical trials and clinical research activity being conducted in the Asian continent, there is an immense need to understand and implement pharmacovigilance. For this to happen, the mind set of people working in regulatory agencies, the Pharmaceutical companies, prescribers and patients/consumers need to change.

  7. [The Portuguese Pharmacovigilance System].

    PubMed

    Herdeiro, Maria Teresa; Ferreira, Mónica; Ribeiro-Vaz, Inês; Junqueira Polónia, Jorge; Costa-Pereira, Altamiro

    2012-01-01

    In Portugal, the National Pharmacovigilance System (NPS) was created in 1992, completing during this year 20 years of existence. Having been established in a centralized manner, it soon became aware that its geographic decentralization would bring advantages in terms of proximity of the System to health professionals as well as the involvement of the universities. The NPS currently has four regional pharmacovigilance centres, which cover the entire mainland, which became centers of scientific vocation, carrying out pharmacoepidemiological studies in the area of drug safety. Also, they are the guarantee of proper collection, processing and evaluation of spontaneous reports of adverse drug reactions (ADRs), as well as the continuing disclosure of the System among health professionals and promotion of spontaneous reporting. Over these 20 years, the NPS has been adapting to the EU requirements in the area of pharmacovigilance, and is currently a mature and well implemented system, with the objectives of the evaluation of the safety profile of marketed drugs and triggering of actions to reduce the risk of these drugs. From the second half of 2012, new adaptation will be run with the implementation of recent European legislation on Pharmacovigilance, published in December 2010. Among other changes, there is the possibility for consumers to report their suspicious of ADR directly to the NPS (exclusive, so far, to health professionals). This work aims to be a reflection about the evolution of the National Pharmacovigilance System and its growing importance in the protection of public health.

  8. Strengthening pharmacovigilance in South Africa.

    PubMed

    Mehta, U; Dheda, M; Steel, G; Blockman, M; Ntilivamunda, A; Maartens, G; Pillay, Y; Cohen, K

    2014-02-01

    This report outlines findings and recommendations of a national pharmacovigilance workshop held in August 2012 in South Africa (SA). A survey of current pharmacovigilance activities, conducted in preparation for the meeting, identified multiple programmes collecting drug safety data in SA, with limited co-ordination at national level. The meeting resolved that existing pharmacovigilance programmes need to be strengthened and consolidated to ensure that important local safety issues are addressed, data can be pooled and compared and outputs shared more widely. Pharmacovigilance activities should inform treatment guidelines with the goal of improving patient care. A variety of pharmaco-epidemiological approaches should be employed, including nesting drug safety studies within existing sentinel cohorts and the creation of a pregnancy exposure registry. The attendees agreed on key principles that will inform a national pharmacovigilance plan and compiled a list of priority pharmacovigilance issues facing public health programmes in SA.

  9. Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

    PubMed

    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.

  10. [Pharmacovigilance of vaccines].

    PubMed

    Autret-Leca, E; Bensouda-Grimaldi, L; Jonville-Béra, A P; Beau-Salinas, F

    2006-02-01

    Safety of vaccines must be excellent to make vaccine's strategy acceptable, since it usually has a deferred individual benefit but immediate adverse drug reactions (ADRs). Pharmacovigilance of vaccines after their marketing is crucial because, prior to its availability on the market, the size of clinical trials is insufficient to identify rare or deferred adverse effects. The Pharmacovigilance is based on "spontaneous reporting" of ADRs to the Pharmacovigilance Regional Centre (PVRC) which establishes a relationship between each drug taken by the patient and the ADRs occurrence (imputability). This method is crucial to generate alerts, but under-estimates the real frequency of ADRs (1 to 10% of severe ADRs are reported). Thus pharmacoepidemiology studies are necessary to confirm the alerts identified by spontaneous reporting. ADRs can be specific, related to the antigen of an attenuated alive virus vaccine (lymphocyte meningitis after anti-mumps vaccine) or non-specific, related to a component different from the antigen (aluminium hydroxide involved in the "macrophagic myofasciitis", allergic reactions to neomycin, latex, egg or gelatine). Importance of Pharmacovigilance of vaccines is illustrated. Data, especially case-control studies, about the relationship between multiple sclerosis and hepatitis B vaccine are summarised. Data about the relationship between Crohn's disease or autism and MMR vaccine are analysed. As vaccines are used in healthy people, their safety must be excellent to be accepted. To monitor them after their marketing is the unique way to detect rare ADRs. This surveillance is made through reporting of ADRs to the PVRC. However, an active and intensive surveillance of ADRs as the one set up from the marketing of Prevenar should be systematic.

  11. Online database for mosquito (Diptera, Culicidae) occurrence records in French Guiana.

    PubMed

    Talaga, Stanislas; Murienne, Jérôme; Dejean, Alain; Leroy, Céline

    2015-01-01

    A database providing information on mosquito specimens (Arthropoda: Diptera: Culicidae) collected in French Guiana is presented. Field collections were initiated in 2013 under the auspices of the CEnter for the study of Biodiversity in Amazonia (CEBA: http://www.labexceba.fr/en/). This study is part of an ongoing process aiming to understand the distribution of mosquitoes, including vector species, across French Guiana. Occurrences are recorded after each collecting trip in a database managed by the laboratory Evolution et Diversité Biologique (EDB), Toulouse, France. The dataset is updated monthly and is available online. Voucher specimens and their associated DNA are stored at the laboratory Ecologie des Forêts de Guyane (Ecofog), Kourou, French Guiana. The latest version of the dataset is accessible through EDB's Integrated Publication Toolkit at http://130.120.204.55:8080/ipt/resource.do?r=mosquitoes_of_french_guiana or through the Global Biodiversity Information Facility data portal at http://www.gbif.org/dataset/5a8aa2ad-261c-4f61-a98e-26dd752fe1c5 It can also be viewed through the Guyanensis platform at http://guyanensis.ups-tlse.fr.

  12. European pharmacovigilance: increasingly outsourced to drug companies.

    PubMed

    2014-12-01

    New regulations reorganising pharmacovigilance at the European level were adopted in late 2010, then revised in 2012 in the wake of the Mediator (benfluorex) disaster. The European Commission's original proposals, released in 2008, would have represented a major step backwards in the protection afforded to European citizens, in particular by facilitating earlier marketing authorisations. Thanks to the mobilisation of civil society, the Members of the European Parliament have improved these proposals, supported by EU health ministers. The role of the new European Pharmacovigilance Risk Assessment Committee (PRAC) has been strengthened. Patients in every Member State have the right to report adverse drug effects directly to health authorities. EU drug regulatory agencies are required to provide greater transparency, and public access to information about adverse effects has been improved. However, one major regression persists: the central role given to pharmaceutical companies in the collection and interpretation of reports of adverse drug effects, despite their conflicts of interest. Drug companies are asked to record the adverse effect reports of which they are aware in a vast European centralised database, Eudravigilance, without going through drug regulatory agencies. Pharmaceutical companies remain responsible for producing "a scientific evaluation of the risk-benefit balance" of their drug, as part of the periodic benefit-risk assessment reports they are required to submit to drug regulatory agencies. These reports are analysed for the entire EU by two Member States (one rapporteur and one co-rapporteur), so that harmonised decisions can be taken. But these decisions are based on data preanalysed by the drug companies. In addition, the independence of the European Medicines Agency is undermined by its financial reliance on the fees paid by pharmaceutical companies in exchange for these assessments. In 2012, following France's Mediator disaster, several modest

  13. Application of the British Food Standards Agency nutrient profiling system in a French food composition database.

    PubMed

    Julia, Chantal; Kesse-Guyot, Emmanuelle; Touvier, Mathilde; Méjean, Caroline; Fezeu, Léopold; Hercberg, Serge

    2014-11-28

    Nutrient profiling systems are powerful tools for public health initiatives, as they aim at categorising foods according to their nutritional quality. The British Food Standards Agency (FSA) nutrient profiling system (FSA score) has been validated in a British food database, but the application of the model in other contexts has not yet been evaluated. The objective of the present study was to assess the application of the British FSA score in a French food composition database. Foods from the French NutriNet-Santé study food composition table were categorised according to their FSA score using the Office of Communication (OfCom) cut-off value ('healthier' ≤ 4 for foods and ≤ 1 for beverages; 'less healthy' >4 for foods and >1 for beverages) and distribution cut-offs (quintiles for foods, quartiles for beverages). Foods were also categorised according to the food groups used for the French Programme National Nutrition Santé (PNNS) recommendations. Foods were weighted according to their relative consumption in a sample drawn from the NutriNet-Santé study (n 4225), representative of the French population. Classification of foods according to the OfCom cut-offs was consistent with food groups described in the PNNS: 97·8 % of fruit and vegetables, 90·4 % of cereals and potatoes and only 3·8 % of sugary snacks were considered as 'healthier'. Moreover, variability in the FSA score allowed for a discrimination between subcategories in the same food group, confirming the possibility of using the FSA score as a multiple category system, for example as a basis for front-of-pack nutrition labelling. Application of the FSA score in the French context would adequately complement current public health recommendations.

  14. Pharmacovigilance is... Vigilance.

    PubMed

    Edwards, I Ralph; Bencheikh, Rachida Soulayamani

    2016-04-01

    The world changes continuously and pharmacovigilance as a new discipline also must change. There are new fields opening with novel challenges whilst we are still perfecting ways to manage and improve the basic challenges such as inadequate data for decision making and under-reporting. Traditional medicines, vaccines, poisoning and medication error are all aspects of the safety of medicines that we have monitored for decades, though without perhaps paying enough attention to their special aspects. There are many new stakeholders taking serious interest in pharmacovigilance outside the regulatory sphere and they often focus on improving individual patient care, rather than the more traditional concentration on broad public health. The same stakeholders are also drawing attention to other iatrogenic outcomes that should be recognised, evaluated and their outcomes compared and contrasted with medication, such as harm from medical devices. The vigilance methods used for medication are very much applicable to all these new fields, though more and different expertise will be needed to evaluate outcomes.

  15. Obstacles to transparency over pharmacovigilance data within the EMA.

    PubMed

    2015-11-01

    In July and August 2014, the European Medicines Agency (EMA) organised two public consultations concerning European pharmacovigilance. These two consultations reveal a number of EMA proposals that are counterproductive to the objective of improving transparency over pharmacovigilance data. The EMA's proposals offer pharmaceutical companies an opportunity to participate in public hearings held by the European Pharmacovigilance Risk Assessment Committee (PRAC), in order to defend their drug. They also provide for the possibility of holding non-public hearings to discuss public data. There is a great risk that the drug industry might use these provisions to influence the debate. The strings attached to the access that the EMA proposes to grant researchers to data contained in the centralised European pharmacovigilance database would allow the EMA to censor the publication of their findings. The EMA seems to regard pharmacovigilance data as commercially confidential information. Responding to these consultations provided an opportunity to remind the EMA that data about adverse effects are a public good, in the common interest, and that it is unacceptable to keep this information confidential.

  16. Treatment performances of French constructed wetlands: results from a database collected over the last 30 years.

    PubMed

    Morvannou, A; Forquet, N; Michel, S; Troesch, S; Molle, P

    2015-01-01

    Approximately 3,500 constructed wetlands (CWs) provide raw wastewater treatment in France for small communities (<5,000 people equivalent). Built during the past 30 years, most consist of two vertical flow constructed wetlands (VFCWs) in series (stages). Many configurations exist, with systems associated with horizontal flow filters or waste stabilization ponds, vertical flow with recirculation, partially saturated systems, etc. A database analyzed 10 years earlier on the classical French system summarized the global performances data. This paper provides a similar analysis of performance data from 415 full-scale two-stage VFCWs from an improved database expanded by monitoring data available from Irstea and the French technical department. Trends presented in the first study are confirmed, exhibiting high chemical oxygen demand (COD), total suspended solids (TSS) and total Kjeldahl nitrogen (TKN) removal rates (87%, 93% and 84%, respectively). Typical concentrations at the second-stage outlet are 74 mgCOD L(-1), 17 mgTSS L(-1) and 11 mgTKN L(-1). Pollutant removal performances are summarized in relation to the loads applied at the first treatment stage. While COD and TSS removal rates remain stable over the range of applied loads, the spreading of TKN removal rates increases as applied loads increase.

  17. French database of children and adolescents with Prader-Willi syndrome

    PubMed Central

    Molinas, Catherine; Cazals, Laurent; Diene, Gwenaelle; Glattard, Melanie; Arnaud, Catherine; Tauber, Maithe

    2008-01-01

    Background Prader-Willi syndrome (PWS) is a rare multisystem genetic disease leading to severe complications mainly related to obesity. We strongly lack information on the natural history of this complex disease and on what factors are involved in its evolution and its outcome. One of the objectives of the French reference centre for Prader-Willi syndrome set-up in 2004 was to set-up a database in order to make the inventory of Prader-Willi syndrome cases and initiate a national cohort study in the area covered by the centre. Description the database includes medical data of children and adolescents with Prader-Willi syndrome, details about their management, socio-demographic data on their families, psychological data and quality of life of the parents. The tools and organisation used to ensure data collection and data quality in respect of good clinical practice procedures are discussed, and main characteristics of our Prader-Willi population at inclusion are presented. Conclusion this database covering all the aspects of PWS clinical, psychological and social profiles, including familial psychological and quality of life will be a powerful tool for retrospective studies concerning this complex and multi factorial disease and could be a basis for the design of future prospective multicentric studies. The complete database and the Stata.do files are available to any researcher wishing to use them for non-commercial purposes and can be provided upon request to the corresponding author. PMID:18831731

  18. An occurence records database of French Guiana harvestmen (Arachnida, Opiliones)

    PubMed Central

    Solbès, Pierre; Grosso, Bernadette

    2014-01-01

    Abstract This dataset provides information on specimens of harvestmen (Arthropoda, Arachnida, Opiliones) collected in French Guiana. Field collections have been initiated in 2012 within the framework of the CEnter for the Study of Biodiversity in Amazonia (CEBA: www.labex-ceba.fr/en/). This dataset is a work in progress.  Occurrences are recorded in an online database stored at the EDB laboratory after each collecting trip and the dataset is updated on a monthly basis. Voucher specimens and associated DNA are also stored at the EDB laboratory until deposition in natural history Museums. The latest version of the dataset is publicly and freely accessible through our Integrated Publication Toolkit at http://130.120.204.55:8080/ipt/resource.do?r=harvestmen_of_french_guiana or through the Global Biodiversity Information Facility data portal at http://www.gbif.org/dataset/3c9e2297-bf20-4827-928e-7c7eefd9432c. PMID:25589875

  19. Pharmacovigilance of herbal medicines.

    PubMed

    Gromek, Kamila; Drumond, Nélio; Simas, Paula

    2015-01-01

    The importance of herbal remedies in pharmacovigilance systems is becoming one of the primary tasks, due to the constantly ascending potential of herbal products and herbal medicines worldwide. Nowadays, the drug development is focused on finding new active compounds or combinations, but costs are simultaneously growing, which makes herbal medicines an attractive, harmless and cheaper alternative to synthetic drugs.Like all drugs, herbal are not free of risk and many studies suggest for potential adverse reactions and interactions. Available statistics show that some herbal products, used in traditional medication for generations, may possess carcinogenic, hepatotoxic, cardiotoxic and other severe actions. Evaluation of the safety should include at least in vitro and in vivo genotoxicity assays, long-term rodent carcinogenicity tests (for drugs intended to be continuously used for >3 months or intermittently for >6 months), reproductive and developmental toxicity studies in some cases and examination of the effects on drug-metabolizing enzymes. Drug safety of herbal medicines should be developed, focusing on specific groups of patients.

  20. Pharmacogenovigilance: a pharmacogenomics pharmacovigilance program.

    PubMed

    Awada, Zeinab; Zgheib, Nathalie Khoueiry

    2014-04-01

    In this report, we review the importance of pharmacovigilance in detecting postmarketing adverse drug events and the potential for developing pharmacogenovigilance programs by integrating pharmacogenomics with pharmacovigilance. We propose to start developing such a program in primary healthcare systems that use basic features of electronic medical records and have access to large numbers of patients commonly prescribed drugs. Such programs, if carefully designed, may grow over time and hopefully enhance the collection and interpretation of useful data for the clinical applications of pharmacogenomics testing.

  1. MANULEX: a grade-level lexical database from French elementary school readers.

    PubMed

    Lété, Bernard; Sprenger-Charolles, Liliane; Colé, Pascale

    2004-02-01

    This article presents MANULEX, a Web-accessible database that provides grade-level word frequency lists of nonlemmatized and lemmatized words (48,886 and 23,812 entries, respectively) computed from the 1.9 million words taken from 54 French elementary school readers. Word frequencies are provided for four levels: first grade (G1), second grade (G2), third to fifth grades (G3-5), and all grades (G1-5). The frequencies were computed following the methods described by Carroll, Davies, and Richman (1971) and Zeno, Ivenz, Millard, and Duvvuri (1995), with four statistics at each level (F, overall word frequency; D, index of dispersion across the selected readers; U, estimated frequency per million words; and SFI, standard frequency index). The database also provides the number of letters in the word and syntactic category information. MANULEX is intended to be a useful tool for studying language development through the selection of stimuli based on precise frequency norms. Researchers in artificial intelligence can also use it as a source of information on natural language processing to simulate written language acquisition in children. Finally, it may serve an educational purpose by providing basic vocabulary lists.

  2. [Case study of Chinese medicine after listing of pharmacovigilance].

    PubMed

    Xiang, Yongyang; Xie, Yanming; Yi, Danhui

    2011-10-01

    With the continuous increasement of adverse Chinese drug reaction reporting, especially Chinese traditional medicine injection, it becomes the key part of the post-marketing evaluation. The issue based on this research background becomes the hot research direction. But the truth is that the history of Chinese medicine and western medicine is different and the theory is not a system either, here different means between pharmacovigilance of Chinese medicine and western medicine, there are still many gaps. This becomes a barrier for Chinese medicine entering the international market. This article summarizes try to order the SFDA's adverse reaction reporting database of traditional Chinese medicine, and using three kinds of data mining methods used by WHO, the U. S. Food and Drug Administration, to establish suitable system for Chinese market after the evaluation of pharmacovigilance.

  3. Pharmacovigilance Discussion Forum--The European Generic Medicines Association's 8th Annual Meeting (January 21, 2015--London, UK).

    PubMed

    Lam, S

    2015-01-01

    The practice and science of pharmacovigilance first emerged following the disaster caused by thalidomide in 1961, which led to the initiation of systemic international efforts to address drug safety issues spearheaded by the WHO. Systems were developed in member states of the WHO to analyze cases of adverse drug reactions (ADRs) and collate these data into a central database to aid national drug regulatory authorities in improving safety profiles of medicines. Pharmacovigilance is a key public health function for monitoring all medicinal products to assess their quality, efficacy and safety before and following authorization. These medicines are continually assessed to detect any aspect that could compromise their safety, and ensure that the necessary measures are taken. In July 2012, new legislation for pharmacovigilance in the E.U. came into effect as a result of the changes set out in the Directive 2010/84/EU and the European Commission (EC) implementing Regulation (EU) No 520/2012 to reduce the increasing number of ADRs. The latest developments in pharmacovigilance in Europe, including news on E.U. pharmacovigilance legislation, were discussed at the 8th European Generic Medicines Association (EGA) Pharmacovigilance Discussion Forum. The meeting facilitated constructive dialogue between regulators and industry on a range of topics including how to simplify pharmacovigilance activities and improve the processes of risk management plans, periodic safety update reports, signal detection, joint studies and inspections.

  4. Pharmacovigilance in Space: Stability Payload Compliance Procedures

    NASA Technical Reports Server (NTRS)

    Daniels, Vernie R.; Putcha, Lakshmi

    2007-01-01

    Pharmacovigilance is the science of, and activities relating to the detection, assessment, understanding, and prevention of drug-related problems. Over the lase decade, pharmacovigilance activities have contributed to the development of numerous technological and conventional advances focused on medication safety and regulatory intervention. The topics discussed include: 1) Proactive Pharmacovigilance; 2) A New Frontier; 3) Research Activities; 4) Project Purpose; 5) Methods; 6) Flight Stability Kit Components; 7) Experimental Conditions; 8) Research Project Logistics; 9) Research Plan; 10) Pharmaceutical Stability Research Project Pharmacovigilance Aspects; 11) Security / Control; 12) Packaging/Containment Actions; 13) Shelf-Life Assessments; 14) Stability Assessment Parameters; 15) Chemical Content Analysis; 16) Preliminary Results; 17) Temperature/Humidity; 18) Changes in PHysical and Chemical Assessment Parameters; 19) Observations; and 20) Conclusions.

  5. Perspectives on the use of data mining in pharmaco-vigilance.

    PubMed

    Almenoff, June; Tonning, Joseph M; Gould, A Lawrence; Szarfman, Ana; Hauben, Manfred; Ouellet-Hellstrom, Rita; Ball, Robert; Hornbuckle, Ken; Walsh, Louisa; Yee, Chuen; Sacks, Susan T; Yuen, Nancy; Patadia, Vaishali; Blum, Michael; Johnston, Mike; Gerrits, Charles; Seifert, Harry; Lacroix, Karol

    2005-01-01

    In the last 5 years, regulatory agencies and drug monitoring centres have been developing computerised data-mining methods to better identify reporting relationships in spontaneous reporting databases that could signal possible adverse drug reactions. At present, there are no guidelines or standards for the use of these methods in routine pharmaco-vigilance. In 2003, a group of statisticians, pharmaco-epidemiologists and pharmaco-vigilance professionals from the pharmaceutical industry and the US FDA formed the Pharmaceutical Research and Manufacturers of America-FDA Collaborative Working Group on Safety Evaluation Tools to review best practices for the use of these methods.In this paper, we provide an overview of: (i) the statistical and operational attributes of several currently used methods and their strengths and limitations; (ii) information about the characteristics of various postmarketing safety databases with which these tools can be deployed; (iii) analytical considerations for using safety data-mining methods and interpreting the results; and (iv) points to consider in integration of safety data mining with traditional pharmaco-vigilance methods. Perspectives from both the FDA and the industry are provided. Data mining is a potentially useful adjunct to traditional pharmaco-vigilance methods. The results of data mining should be viewed as hypothesis generating and should be evaluated in the context of other relevant data. The availability of a publicly accessible global safety database, which is updated on a frequent basis, would further enhance detection and communication about safety issues.

  6. Pharmacovigilance and the italian medicines agency.

    PubMed

    Pimpinella, Giuseppe; Tartaglia, Loriana

    2013-12-01

    The new European Union (EU) regulations on pharmacovigilance require that the national systems are strengthened in order to fit the new requirements. The Italian Pharmacovigilance System, coordinated by the Italian Medicines Agency (AIFA), is made by local and regional structures. In 2007, a program for funding active pharmacovigilance projects in the Italian Regions was established by the National law. The AIFA is responsible for the preparation of guidelines aimed at the identification of research areas and for the approval of the projects submitted by the regions. In April 2012, the AIFA started a program of visits at the regional pharmacovigilance centers (RPCs), aimed at monitoring their performances, evaluating the quality of the activities in order to understand the main differences and discrepancies and with a view to start a program of harmonization of the procedures in place. The outcome of the visits program highlighted major differences among the quality management systems of the various centers; hence, AIFA has decided to launch an initiative to promote in the next months the harmonization of procedures. The synergy among AIFA, regional structures, RPCs, and local structure responsible for pharmacovigilance is needed in order to establish a robust pharmacovigilance system working in full compliance with the provisions of the new EU legislation.

  7. 3D Pharmacophoric Similarity improves Multi Adverse Drug Event Identification in Pharmacovigilance

    NASA Astrophysics Data System (ADS)

    Vilar, Santiago; Tatonetti, Nicholas P.; Hripcsak, George

    2015-03-01

    Adverse drugs events (ADEs) detection constitutes a considerable concern in patient safety and public health care. For this reason, it is important to develop methods that improve ADE signal detection in pharmacovigilance databases. Our objective is to apply 3D pharmacophoric similarity models to enhance ADE recognition in Offsides, a pharmacovigilance resource with drug-ADE associations extracted from the FDA Adverse Event Reporting System (FAERS). We developed a multi-ADE predictor implementing 3D drug similarity based on a pharmacophoric approach, with an ADE reference standard extracted from the SIDER database. The results showed that the application of our 3D multi-type ADE predictor to the pharmacovigilance data in Offsides improved ADE identification and generated enriched sets of drug-ADE signals. The global ROC curve for the Offsides ADE candidates ranked with the 3D similarity score showed an area of 0.7. The 3D predictor also allows the identification of the most similar drug that causes the ADE under study, which could provide hypotheses about mechanisms of action and ADE etiology. Our method is useful in drug development, screening potential adverse effects in experimental drugs, and in drug safety, applicable to the evaluation of ADE signals selected through pharmacovigilance data mining.

  8. 3D pharmacophoric similarity improves multi adverse drug event identification in pharmacovigilance.

    PubMed

    Vilar, Santiago; Tatonetti, Nicholas P; Hripcsak, George

    2015-03-06

    Adverse drugs events (ADEs) detection constitutes a considerable concern in patient safety and public health care. For this reason, it is important to develop methods that improve ADE signal detection in pharmacovigilance databases. Our objective is to apply 3D pharmacophoric similarity models to enhance ADE recognition in Offsides, a pharmacovigilance resource with drug-ADE associations extracted from the FDA Adverse Event Reporting System (FAERS). We developed a multi-ADE predictor implementing 3D drug similarity based on a pharmacophoric approach, with an ADE reference standard extracted from the SIDER database. The results showed that the application of our 3D multi-type ADE predictor to the pharmacovigilance data in Offsides improved ADE identification and generated enriched sets of drug-ADE signals. The global ROC curve for the Offsides ADE candidates ranked with the 3D similarity score showed an area of 0.7. The 3D predictor also allows the identification of the most similar drug that causes the ADE under study, which could provide hypotheses about mechanisms of action and ADE etiology. Our method is useful in drug development, screening potential adverse effects in experimental drugs, and in drug safety, applicable to the evaluation of ADE signals selected through pharmacovigilance data mining.

  9. Pharmacovigilance in pharmaceutical companies: An overview.

    PubMed

    Mammì, Maria; Citraro, Rita; Torcasio, Giovanni; Cusato, Gennaro; Palleria, Caterina; di Paola, Eugenio Donato

    2013-12-01

    Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs).

  10. EU's new pharmacovigilance legislation: considerations for biosimilars.

    PubMed

    Calvo, Begoña; Zuñiga, Leyre

    2014-01-01

    Biosimilars are biological medicines, the active substances of which are highly similar to those of biologics that have already been authorized. As for any other medicine, the applicant of the biosimilar marketing authorization must submit a risk-management plan (RMP)/pharmacovigilance plan. The pharmacovigilance plan should take into account risks identified during product development, the potential risks and how those risks will be addressed after authorization of the product.Recently, new European Pharmacovigilance legislation has been implemented, ensuring proper risk management through the recording of suspected adverse drug reactions and data collection from all stakeholders. The new regulation entails a reduction of the administrative burden on companies and regulatory agencies, as obligations of the responsible parties are clearly established and duplication of effort avoided.This article analyzes the new European Pharmacovigilance System requirements, with special focus on those medicines requiring additional monitoring, such as biosimilars, which are priorities for pharmacovigilance. Further, it provides the new obligations to marketing authorization holders, such as the continuous benefit-risk assessment.

  11. Gathering and exploring scientific knowledge in pharmacovigilance.

    PubMed

    Lopes, Pedro; Nunes, Tiago; Campos, David; Furlong, Laura Ines; Bauer-Mehren, Anna; Sanz, Ferran; Carrascosa, Maria Carmen; Mestres, Jordi; Kors, Jan; Singh, Bharat; van Mulligen, Erik; Van der Lei, Johan; Diallo, Gayo; Avillach, Paul; Ahlberg, Ernst; Boyer, Scott; Diaz, Carlos; Oliveira, José Luís

    2013-01-01

    Pharmacovigilance plays a key role in the healthcare domain through the assessment, monitoring and discovery of interactions amongst drugs and their effects in the human organism. However, technological advances in this field have been slowing down over the last decade due to miscellaneous legal, ethical and methodological constraints. Pharmaceutical companies started to realize that collaborative and integrative approaches boost current drug research and development processes. Hence, new strategies are required to connect researchers, datasets, biomedical knowledge and analysis algorithms, allowing them to fully exploit the true value behind state-of-the-art pharmacovigilance efforts. This manuscript introduces a new platform directed towards pharmacovigilance knowledge providers. This system, based on a service-oriented architecture, adopts a plugin-based approach to solve fundamental pharmacovigilance software challenges. With the wealth of collected clinical and pharmaceutical data, it is now possible to connect knowledge providers' analysis and exploration algorithms with real data. As a result, new strategies allow a faster identification of high-risk interactions between marketed drugs and adverse events, and enable the automated uncovering of scientific evidence behind them. With this architecture, the pharmacovigilance field has a new platform to coordinate large-scale drug evaluation efforts in a unique ecosystem, publicly available at http://bioinformatics.ua.pt/euadr/.

  12. Pharmacovigilance Programme of India: Recent developments and future perspectives

    PubMed Central

    Kalaiselvan, Vivekanandan; Thota, Prasad; Singh, Gyanendra Nath

    2016-01-01

    Promoting safe use of medicines is a priority of Indian Pharmacopoeia Commission that functions as the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI). One hundred and seventy-nine adverse drug reactions (ADRs) monitoring centers currently report ADRs to NCC. Current India contribution to global safety database reaches 3% and the completeness score is 0.93 out of 1. NCC is taking several measures to enhance patient safety including capacity building for monitoring, surveillance, collaboration with national health programs and other organizations to increase ADR reporting and to ensure that PvPI is a vital knowledge database for Indian regulators. The Central Drugs Standard Control Organization has notified important safety label changes on drugs such as carbamazepine and piperacillin + tazobactam in the year 2015, other drugs are under monitoring for regulatory interventions. PMID:28066097

  13. Identifying multiple myeloma patients using data from the French health insurance databases

    PubMed Central

    Palmaro, Aurore; Gauthier, Martin; Conte, Cécile; Grosclaude, Pascale; Despas, Fabien; Lapeyre-Mestre, Maryse

    2017-01-01

    Abstract This study aimed to assess the performance of several algorithms based on hospital diagnoses and the long-term diseases scheme to identify multiple myeloma patients. Potential multiple myeloma patients in 2010 to 2013 were identified using the presence of hospital records with at least 1 main diagnosis code for multiple myeloma (ICD-10 “C90”). Alternative algorithms also considered related and associated diagnoses, combination with long-term conditions, or at least 2 diagnoses. Incident patients were those with no previous “C90” codes in the past 24 or 12 months. The sensitivity, specificity, and positive and negative predictive values (PPVs and NPVs) were computed, using a French cancer registry for the corresponding area and period as the criterion standard. Long-term conditions data extracted concerned 11,559 patients (21,846 for hospital data). The registry contained 125 cases of multiple myeloma. Sensitivity was 70% when using only main hospital diagnoses (specificity 100%, PPV 79%), 76% when also considering related diagnoses (specificity 100%, PPV 74%), and 90% with associated diagnoses included (100% specificity, 64% PPV). In relation with their good performance, selected algorithms can be used to study the benefit and risk of drugs in treated multiple myeloma patients. PMID:28328805

  14. Pharmacovigilance in Europe: Place of the Pharmacovigilance Risk Assessment Committee (PRAC) in organisation and decisional processes.

    PubMed

    Laroche, Marie-Laure; Batz, Arnaud; Géniaux, Hélène; Féchant, Corinne; Merle, Louis; Maison, Patrick

    2016-04-01

    The new European legislation that came into force in July 2012 reinforced the organisation of pharmacovigilance by setting up a committee in charge of risk assessment for medicines, the Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC has a remit covering the assessment of all aspects of the safety and the risk management of medicinal products for human use in the European Union. It deals with issues regarding pharmacovigilance signals, the periodic evaluation of benefit/risk reports from marketing authorization holders (MAH), risk management plans, post-marketing studies, variations or renewals of marketing authorisations, management of under surveillance drugs lists, inspections for pharmacovigilance reasons and audits of pharmacovigilance systems. The PRAC works with the pharmacovigilance systems of the European Member States, which draw up evaluation reports. These evaluations are circulated and discussed by Member States so as to issue recommendations, which serve as a basis for other European medicines committees, the Committee for Medicinal Products for Human Use (CHMP) or the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) which then give their opinion. The final decision, which applies to all Member States and to the concerned MAH, lies with the European Commission (EC). This decisional procedure thus rests on coordination involving the PRAC, the CHMP, the CMDh, the EC, the Member States and the pharmaceutical companies. In the 3 years from July 2012, the PRAC has processed nearly 4500 procedures and is still facing an increasing workload.

  15. The use of a medico economic database as a part of French apheresis registry.

    PubMed

    Kanouni, T; Aubas, P; Heshmati, F

    2017-02-01

    An apheresis registry is a part of each learned apheresis society. The interest in this is obvious, in terms of knowledge of the practice of apheresis, adverse events, and technical issues. However, because of the weight of data entry it could never be exhaustive and some data will be missing. While continuing our registry efforts and our efforts to match with other existing registries, we decided to extend the data collection to a medico-economic database that is available in France, the Programme de Médicalisation du Système d'Information (PMSI) that has covered reimbursement information for each public or private hospital since 2007. It contains almost all apheresis procedures in all apheresis fields, demographic patient data, and primary and related diagnoses, among other data. Although this data does not include technical apheresis issues or other complications of the procedures, its interest is great and it is complementary to the registry. From 2003-2014, we have recorded 250,585 apheresis procedures, for 48,428 patients. We showed that the data are reliable and exhaustive. The information shows a perfect real life practice in apheresis, regarding indications, the rhythm and the duration of apheresis treatment. This prospective data collection is sustainable and allows us to assess the impact of healthcare guidelines. Our objective is to extend the data collection and match it to other existing databases; this will allow us to conduct, for example, a cohort study specifically for ECP.

  16. Choice of ICD-10 codes for the identification of acute coronary syndrome in the French hospitalization database.

    PubMed

    Bezin, Julien; Girodet, Pierre-Olivier; Rambelomanana, Sahondra; Touya, Maëlys; Ferreira, Paul; Gilleron, Véronique; Robinson, Philip; Moore, Nicholas; Pariente, Antoine

    2015-12-01

    The objective of this study was to evaluate the performance of the ICD-10 (International Classification of Diseases and Related Health Problems, 10(th) Edition) coding in the French hospitalization database (PMSI) to identify acute coronary syndrome (ACS) occurrence. Eligible hospitalizations were those that occurred at the Bordeaux teaching hospitals between 1 January 2011 and 31 December 2011 and had one of the ICD-10 codes related to ischaemic heart diseases (I20 to I25, excluding I23 and I25.2). Among these, 100 hospitalizations were randomly selected; for each case, the ACS diagnosis was confirmed/excluded after medical file examination by an independent events validation committee and the performance of codes, and combinations of codes, to identify ACS was evaluated by calculating the positive predictive value (PPV). Of the individual codes, I20.0, I21 and I24 had the highest PPV; 100.0% for I24 (95%CI [15.8-100.0]); 90.0% for I21 (95%CI [76.3-97.2]); and 66.7% for I20.0 (95%CI [38.4-88.2]). The combination of I20.0 or I24 codes was able to identify 12 of the 56 validated ACS cases with a PPV of 70.6% (95%CI [44.0-89.7]), the combination of I21 or I24 identified 38 cases with a PPV of 90.5% (95%CI [77.4-97.3]), the combination of I20.0 or I21 identified 46 cases with a PPV of 83.6% (95%CI [71.2-92.2]), and the combination of I20.0, I21 or I24 identified 48 cases with a PPV of 84.2% (95%CI [72.1-92.5]). The combination of I20.0, I21 or I24 codes had the best performance to identify occurrence of ACS in the French hospitalization database.

  17. Pharmacoepidemiology and its input to pharmacovigilance.

    PubMed

    Faillie, Jean-Luc; Montastruc, François; Montastruc, Jean-Louis; Pariente, Antoine

    2016-04-01

    The aim of this article is to discuss the contribution of pharmacoepidemiology to pharmacovigilance in the context of drug safety monitoring. Because this contribution requires a comparison of the approaches and a presentation of their respective merits, we have tried to show that this comparison did not necessarily mean opposing these methods, which would not serve any useful purpose. We wanted to underline the fact that the notion of contribution of one to the other implied a complementarity that we propose to demonstrate. Pharmacovigilance is essentially based on the study of spontaneous reports and the clinical and pharmaceutical analysis of the implication of given drugs in adverse drug reactions. It yields performances that are unequalled to this day when safety warning signs relate to rare adverse events or to drugs that are rarely used, or when the drug-related event has specificities that are not found for other aetiologies. Pharmacoepidemiology for its part, through its population-related studies and the possible use of a comparison group, enables a quantification of risks that is impossible to carry out using spontaneous reporting alone. It also enables the highlighting and quantification of safety signals for events that are frequent and multifactorial, where the role of a drug in individual cases can be difficult to detect, and therefore difficult to identify from spontaneous reporting. All in all, this is the major contribution of pharmacoepidemiology to pharmacovigilance, where it can be said that it complements pharmacovigilance in drug safety monitoring but in no way could replace it.

  18. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.

    PubMed

    Borg, John-Joseph; Aislaitner, George; Pirozynski, Michal; Mifsud, Stephen

    2011-03-01

    medicines through risk management and structured data collection in the form of Post-Authorization Safety Studies (PASS), together with rationalized single-case and periodic reporting of suspected adverse drug reactions (ADRs); (vi) involvement of stakeholders in pharmacovigilance through direct patient reporting of suspected ADRs and inclusion of patients and healthcare professionals in decision making; and (vii) simplification of the current community pharmacovigilance procedures with consequent efficiency gains for both the pharmaceutical industry and medicines regulators. For the first time, companies can be made legally liable to carry out PASS and Post-Authorization Efficacy Studies. The amendments to the Regulation and to the Directive will strengthen the European network on pharmacovigilance. A Pharmacovigilance Risk Assessment Committee (PRAC) based at the EMA will be set up, which will be responsible for all matters related to pharmacovigilance at an EU level. Three European databases will be strengthened (EudraVigilance, EudraPharm and the European Pharmacovigilance issues Tracking Tool) as well as the setting up of an EU safety portal to better inform the public on all safety issues being discussed at an EU level. Public hearings at the PRAC will improve transparency in the decision-making process, whilst details and results of all PASS agreed to by the PRAC will also be made publically available.

  19. French brain tumor database: 5-year histological results on 25 756 cases.

    PubMed

    Rigau, Valérie; Zouaoui, Sonia; Mathieu-Daudé, Hélène; Darlix, Amélie; Maran, Aurélie; Trétarre, Brigitte; Bessaoud, Faiza; Bauchet, Fabienne; Attaoua, Redha; Fabbro-Peray, Pascale; Fabbro, Michel; Kerr, Christine; Taillandier, Luc; Duffau, Hugues; Figarella-Branger, Dominique; Costes, Valérie; Bauchet, Luc

    2011-11-01

    This work aimed to prospectively record all primary central nervous system tumor (PCNST) cases in France, for which histological diagnosis is available. The objectives were to (i) create a national registry and a network to perform epidemiological studies; (ii) implement clinical and basic research protocols; and (iii) harmonize the health care of patients affected by PCNST. For 5 years, 25 756 cases of newly diagnosed and histologically confirmed PCNST have been recorded. Histological diagnoses included glioma (48.9%), all other neuroepithelial tumors (5%), meningioma (28.8%), nerve sheath tumors (8.4%), lymphoma (3.2%) and others (5.7%). Cryopreservation was reported for 6018 PCNST specimens. Tumor resections (R) were performed in 78% cases, while biopsies accounted for 22%. Median age (MA), sex, percentage R and number of cryopreserved tumors were detailed for each histology; for example, out of 6053 glioblastomas (MA 63 years, male 59.4%, R 62%, 1611 were cryopreserved), and out of 37 atypical teratoid/rhabdoid tumors (MA 2 years, male 56.8%, R 94%, 17 were cryopreserved). This database or databank dedicated to PCNST cases contains detailed data on clinical, histological and other characteristics, such as the inclusion of data on cryopreserved specimens that are not available in other European registries. Therefore, this is a valuable resource that can be used for planning future epidemiological and clinical research.

  20. Pharmacovigilance in clinical dentistry: overlooked or axiomatic?

    PubMed

    Carnelio, Sunitha; Khan, Sohil Ahmed; Rodrigues, Gabriel

    2011-01-01

    Developments in dental pharmacotherapeutics require dentists to constantly update their knowledge of new drugs, drug safety, and therapeutic trends. Recent incidents of bisphosphonateassociated poor healing, spontaneous intraoral ulceration, and bone necrosis in the oral and maxillofacial region stress the need for vigilant spontaneous reporting of adverse events. This article discusses the rationale for pharmacovigilance in dental practice using specific methods and reviews the pros and cons of adverse drug reporting among dental practitioners.

  1. DNA Barcoding and Pharmacovigilance of Herbal Medicines.

    PubMed

    de Boer, Hugo J; Ichim, Mihael C; Newmaster, Steven G

    2015-07-01

    Pharmacovigilance of herbal medicines relies on the product label information regarding the ingredients and the adherence to good manufacturing practices along the commercialisation chain. Several studies have shown that substitution of plant species occurs in herbal medicines, and this in turn poses a challenge to herbal pharmacovigilance as adverse reactions might be due to adulterated or added ingredients. Authentication of constituents in herbal medicines using analytical chemistry methods can help detect contaminants and toxins, but are often limited or incapable of detecting the source of the contamination. Recent developments in molecular plant identification using DNA sequence data enable accurate identification of plant species from herbal medicines using defined DNA markers. Identification of multiple constituent species from compound herbal medicines using amplicon metabarcoding enables verification of labelled ingredients and detection of substituted, adulterated and added species. DNA barcoding is proving to be a powerful method to assess species composition in herbal medicines and has the potential to be used as a standard method in herbal pharmacovigilance research of adverse reactions to specific products.

  2. [Interpretation of Guidelines on Good Pharmacovigilance Practices for European Union].

    PubMed

    Xie, Yan-Ming; Tian, Feng

    2013-09-01

    Due to the limitations of pre-authorization clinical trials, the safety information obtained from them is relatively limited. Therefore, it is very necessary to carry out pharmacovigilance activities on drugs post-marketing. In order to promote the specific implementation of the new pharmacovigilance regulations, the European medicines agency (EMA) developed the Guideline on Good Pharmacovigilance Practices (GVP), as the new criteria for pharmacovigilance in the European Union (EU). Compared with the previously published, Guidelines on Pharmacovigilance for Medicinal Products for Human Use (2007), the GVP proposed more comprehensive and systematic provisions of pharmacovigilance systems, quality control systems, judgements, pharmacovigilance inspections and audits. In addition, it set more specific and comprehensive requirements on risk management systems, the management and reporting of adverse reactions to medicinal products, periodic safety update reports, post-authorization safety studies, signal management, and so on. Interpreting the basic principles, working mechanisms, key technologies and methods of the GVP provides a useful reference for us to carry out pharmacovigilance (especially regarding safety monitoring of parenterally administered Chinese medicine).

  3. Safety of fibrinogen concentrate: analysis of more than 27 years of pharmacovigilance data.

    PubMed

    Solomon, C; Gröner, A; Ye, J; Pendrak, I

    2015-04-01

    Fibrinogen concentrate use as a haemostatic agent has been increasingly explored. This study evaluates spontaneous reports of potential adverse drug reactions (ADRs) that occurred during postmarketing pharmacovigilance of Haemocomplettan P/RiaSTAP, and reviews published safety data. This descriptive study analysed postmarketing safety reports recorded in the CSL Behring pharmacovigilance database from January 1986 to December 2013. A literature review of clinical studies published during the same period was performed. Commercial data indicated that 2,611,294 g of fibrinogen concentrate were distributed over the pharmacovigilance period, corresponding to 652,824 standard doses of 4 g each, across a range of clinical settings and indications. A total of 383 ADRs in 106 cases were reported (approximately 1 per 24,600 g or 6,200 standard doses). Events of special interest included possible hypersensitivity reactions in 20 cases (1 per 130,600 g or 32,600 doses), possible thromboembolic events in 28 cases (1 per 93,300 g or 23,300 doses), and suspected virus transmission in 21 cases (1 per 124,300 g or 31,000 doses). One virus transmission case could not be analysed due to insufficient data; for all other cases, a causal relationship was assessed as unlikely due to negative polymerase chain reaction tests and/or alternative explanations. The published literature revealed a similar safety profile. In conclusion, underreporting of ADRs is a known limitation of pharmacovigilance. However, the present assessment indicates that fibrinogen concentrate is administered across a range of indications, with few ADRs and a low thromboembolic event rate. Overall, fibrinogen concentrate showed a promising safety profile.

  4. Does language matter? A case study of epidemiological and public health journals, databases and professional education in French, German and Italian

    PubMed Central

    Baussano, Iacopo; Brzoska, Patrick; Fedeli, Ugo; Larouche, Claudia; Razum, Oliver; Fung, Isaac C-H

    2008-01-01

    Epidemiology and public health are usually context-specific. Journals published in different languages and countries play a role both as sources of data and as channels through which evidence is incorporated into local public health practice. Databases in these languages facilitate access to relevant journals, and professional education in these languages facilitates the growth of native expertise in epidemiology and public health. However, as English has become the lingua franca of scientific communication in the era of globalisation, many journals published in non-English languages face the difficult dilemma of either switching to English and competing internationally, or sticking to the native tongue and having a restricted circulation among a local readership. This paper discusses the historical development of epidemiology and the current scene of epidemiological and public health journals, databases and professional education in three Western European languages: French, German and Italian, and examines the dynamics and struggles they have today. PMID:18826570

  5. Using real-world healthcare data for pharmacovigilance signal detection - the experience of the EU-ADR project.

    PubMed

    Patadia, Vaishali K; Coloma, Preciosa; Schuemie, Martijn J; Herings, Ron; Gini, Rosa; Mazzaglia, Giampiero; Picelli, Gino; Fornari, Carla; Pedersen, Lars; van der Lei, Johan; Sturkenboom, Miriam; Trifirò, Gianluca

    2015-01-01

    A prospective pharmacovigilance signal detection study, comparing the real-world healthcare data (EU-ADR) and two spontaneous reporting system (SRS) databases, US FDA's Adverse Event Reporting System and WHO's Vigibase is reported. The study compared drug safety signals found in the EU-ADR and SRS databases. The potential for signal detection in the EU-ADR system was found to be dependent on frequency of the event and utilization of drugs in the general population. The EU-ADR system may have a greater potential for detecting signals for events occurring at higher frequency in general population and those that are commonly not considered as potentially a drug-induced event. Factors influencing various differences between the datasets are discussed along with potential limitations and applications to pharmacovigilance practice.

  6. Causality Assessment in Pharmacovigilance: Still a Challenge.

    PubMed

    Ralph Edwards, I

    2017-02-28

    Causality in pharmacovigilance is a difficult and time consuming exercise. This paper presents the challenges in determining causation by drug therapy. The first is that causation is complex and needs to be viewed from the context of the patient treated, rather than the drug product. Multiple causal vectors should be considered if we are to tackle the many issues involved in, for example, medication error and the many other factors that lead to bad outcomes from therapy, including failure to recognise known risk factors. The aim of pharmacovigilance is not only a bureaucratic exercise in public health norms, but is mainly concerned with small minorities of statistical outliers-and even individuals-whose experiences from harms may together form messages about causation that will prevent further at-risk patients from exposure, or at least assist with earlier recognition of drug-related harm and better management of such harm. This requires more time, more data, more analysis and more patient and clinical involvement in reporting useful clinical detail. The paradigm shift back towards gathering more case data relating to possible causation can be selective and would not be just retrogressive, nor necessarily too costly. Greater transparency of hypotheses and availability of anonymised case data will enrol more expertise into evaluations and hypothesis testing, and the provision of more complete and useful information should reduce clinical burdens from bad patient outcomes as well as their overall costs to society.

  7. Mining pharmacovigilance data using Bayesian logistic regression with James-Stein type shrinkage estimation.

    PubMed

    An, Lihua; Fung, Karen Y; Krewski, Daniel

    2010-09-01

    Spontaneous adverse event reporting systems are widely used to identify adverse reactions to drugs following their introduction into the marketplace. In this article, a James-Stein type shrinkage estimation strategy was developed in a Bayesian logistic regression model to analyze pharmacovigilance data. This method is effective in detecting signals as it combines information and borrows strength across medically related adverse events. Computer simulation demonstrated that the shrinkage estimator is uniformly better than the maximum likelihood estimator in terms of mean squared error. This method was used to investigate the possible association of a series of diabetic drugs and the risk of cardiovascular events using data from the Canada Vigilance Online Database.

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

    PubMed

    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.

  9. How can the quality of medical data in pharmacovigilance, pharmacoepidemiology and clinical studies be guaranteed?

    PubMed

    Alla, François; Rosilio, Myriam; Funck-Brentano, Christian; Barthélémy, Philippe; Brisset, Sophie; Cellier, Dominic; Chassany, Olivier; Demarez, Jean-Paul; Diebolt, Vincent; Francillon, Alain; Gambotti, Laetitia; Hannachi, Hakima; Lechat, Philippe; Lemaire, François; Lièvre, Michel; Misse, Christophe; Nguon, Marina; Pariente, Antoine; Rosenheim, Michel; Weisslinger-Darmon, Nadine

    2013-01-01

    The development of medicinal products is subject to quality standards aimed at guaranteeing that database contents accurately reflect the source documents. Paradoxically, these standards hardly address the quality of the source data itself. The objective of this work was to propose recommendations to improve data quality in three fields (pharmacovigilance, pharmacoepidemiology and clinical studies). The analysis was focused on the data and on the critical stages presenting critical quality problems, for which the current guidelines are insufficiently detailed, unsuitable and/or poorly applied. Finally, recommendations have been proposed, mainly focused on the origin of the data and its transcription.

  10. European Union pharmacovigilance capabilities: potential for the new legislation.

    PubMed

    Borg, John Joseph; Tanti, Amy; Kouvelas, Dimitrios; Lungu, Calin; Pirozynski, Michal; Serracino-Inglott, Anthony; Aislaitner, George

    2015-08-01

    European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed.

  11. European Union pharmacovigilance capabilities: potential for the new legislation

    PubMed Central

    Tanti, Amy; Kouvelas, Dimitrios; Lungu, Calin; Pirozynski, Michal; Serracino-Inglott, Anthony; Aislaitner, George

    2015-01-01

    European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed. PMID:26301067

  12. Statistical methods for active pharmacovigilance, with applications to diabetes drugs.

    PubMed

    Zhuo, Lan; Farrell, Patrick J; McNair, Doug; Krewski, Daniel

    2014-01-01

    Pharmacovigilance aims to identify adverse drug reactions using postmarket surveillance data under real-world conditions of use. Unlike passive pharmacovigilance, which is based on largely voluntary (and hence incomplete) spontaneous reports of adverse drug reactions with limited information on patient characteristics, active pharmacovigilance is based on electronic health records containing detailed information about patient populations, thereby allowing consideration of modifying factors such as polypharmacy and comorbidity, as well as sociodemographic characteristics. With the present shift toward active pharmacovigilance, statistical methods capable of addressing the complexities of such data are needed. We describe four such methods here, and demonstrate their application in the analysis of a large retrospective cohort of diabetics taking anti-hyperglycemic medications that may increase the risk of adverse cardiovascular events.

  13. Pharmacovigilance in China: current situation, successes and challenges.

    PubMed

    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.

  14. Pharmacovigilance: Boon for the safety and efficacy of Ayuvedic formulations

    PubMed Central

    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

  15. Harnessing Scientific Literature Reports for Pharmacovigilance

    PubMed Central

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

    2017-01-01

    Summary Objectives 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. Methods 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. Results 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. Conclusions 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. PMID:28326432

  16. Naming times and standardized norms for the Italian PD/DPSS set of 266 pictures: direct comparisons with American, English, French, and Spanish published databases.

    PubMed

    Dell'Acqua, R; Lotto, L; Job, R

    2000-11-01

    The present study provides Italian normative measures for 266 line drawings belonging to the new set of pictures developed by Lotto, Dell'Acqua, and Job (in press). The pictures have been standardized on the following measures: number of letters, number of syllables, name frequency, within-category typically, familiarity, age of acquisition, name agreement, and naming time. In addition to providing the measures, the present study focuses on indirect and direct comparisons (i.e., correlations) of the present norms with databases provided by comparable studies in Italian (in which normative data were collected with Snodgrass & Vanderwart's set of pictures; Nisi, Longoni, & Snodgrass, 2000), in British English (Barry, Morrison, & Ellis, 1997), in American English (Snodgrass & Vanderwart, 1980; Snodgrass & Yuditsky, 1996), in French (Alario & Ferrand, 1999), and in Spanish (Sanfeliu & Fernandez, 1996).

  17. A qualitative approach to signal mining in pharmacovigilance using formal concept analysis.

    PubMed

    Lillo-Le Louët, Agnès; Toussaint, Yannick; Villerd, Jean

    2010-01-01

    "Pharmacovigilance is the process and science of monitoring the safety of medicines, consisting in (i) collecting and managing data on the safety of medicines (ii) looking at the data to detect 'signals' (any new or changing safety issue)" [1]. Pharmacovigilance is mainly based on spontaneous reports: when suspecting an adverse drug reaction, health care practitioners send a report to a spontaneous reporting system (SRS). This produces huge databases containing numerous reports and their manual exploration is both cost and time prohibitive. Existing techniques that automatically extract relevant signals rely on statistics or Bayesian models but do not provide information to the experts about possible biases lying in the data, nor about the specificity of a signal to a particular patient profile. Our extraction method combines numerical methods from the state of the art with a qualitative approach that helps interpretation. We build a synthetic representation of the database that is used to (i) identify unexpected patterns and biases (ii) extract potentially relevant signals w.r.t. patient profiles (iii) provide traceability facilities between extracted signals and raw data.

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

    PubMed

    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.

  19. 75 FR 65293 - Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-22

    ... Animal and Plant Health Inspection Service Draft Guidelines on Pharmacovigilance of Veterinary Medicinal... on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal...

  20. Identifying multiple myeloma patients using data from the French health insurance databases: Validation using a cancer registry.

    PubMed

    Palmaro, Aurore; Gauthier, Martin; Conte, Cécile; Grosclaude, Pascale; Despas, Fabien; Lapeyre-Mestre, Maryse

    2017-03-01

    This study aimed to assess the performance of several algorithms based on hospital diagnoses and the long-term diseases scheme to identify multiple myeloma patients.Potential multiple myeloma patients in 2010 to 2013 were identified using the presence of hospital records with at least 1 main diagnosis code for multiple myeloma (ICD-10 "C90"). Alternative algorithms also considered related and associated diagnoses, combination with long-term conditions, or at least 2 diagnoses. Incident patients were those with no previous "C90" codes in the past 24 or 12 months. The sensitivity, specificity, and positive and negative predictive values (PPVs and NPVs) were computed, using a French cancer registry for the corresponding area and period as the criterion standard.Long-term conditions data extracted concerned 11,559 patients (21,846 for hospital data). The registry contained 125 cases of multiple myeloma. Sensitivity was 70% when using only main hospital diagnoses (specificity 100%, PPV 79%), 76% when also considering related diagnoses (specificity 100%, PPV 74%), and 90% with associated diagnoses included (100% specificity, 64% PPV).In relation with their good performance, selected algorithms can be used to study the benefit and risk of drugs in treated multiple myeloma patients.

  1. What Can Big Data Offer the Pharmacovigilance of Orphan Drugs?

    PubMed

    Price, John

    2016-12-01

    The pharmacovigilance of drugs for orphan diseases presents problems related to the small patient population. Obtaining high-quality information on individual reports of suspected adverse reactions is of particular importance for the pharmacovigilance of orphan drugs. The possibility of mining "big data" to detect suspected adverse reactions is being explored in pharmacovigilance generally but may have limited application to orphan drugs. Sources of big data such as social media may be infrequently used as communication channels by patients with rare disease or their caregivers or by health care providers; any adverse reactions identified are likely to reflect what is already known about the safety of the drug from the network of support that grows up around these patients. Opportunities related to potential future big data sources are discussed.

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

    PubMed Central

    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. PMID:21701609

  3. Opportunities for Collaboration at the Interface of Pharmacovigilance and Manufacturing.

    PubMed

    Beninger, Paul

    2017-03-30

    A case can be made that much common ground exists between pharmacovigilance and pharmaceutical manufacturing. Of the 8 major US statutes that shaped the pharmaceutical industry since early in the 20th Century, 7 followed fatally catastrophic events related to the use of a manufactured product, and 1 followed the discovery of a counterfeit product. To facilitate an understanding of the interplay between pharmacovigilance and manufacturing, it is convenient to divide manufacturing into 3 categories: (1) upstream sourcing of materials: pharmacovigilance plays an important role when adverse event clusters are seen during routine vigilance detection processes and the suspicion turns to possibly contaminated source material, (2) the manufacturing process itself: pharmacovigilance may be called on to conduct a health hazard evaluation if a manufacturing deviation is detected after product release (the assessment can inform the depth of a recall), and (3) downstream distribution and product use: there is only light regulation of the interval between product distribution after manufacturing release and just before administration to patients, a time during which product may be subject to an out-of-specification determination for environmental controls or subject to malfeasant activities, such as counterfeit substitution or product diversion. Recently introduced statutory remedies, including the FDA Safety and Innovation Act and the Drug Supply Chain Security Act in the United States and the Falsified Medicines Directive (directive 2011/62/EC) in the European Union, can provide capabilities to support pharmacovigilance signal management activities that have the potential to reduce the risk to patients of experiencing adverse events caused by counterfeit, diverted, or tampered product.

  4. Pharmacovigilance of herbal medicines in Africa: Questionnaire study.

    PubMed

    Skalli, Souad; Bencheikh, Rachida Soulaymani

    2015-08-02

    In order to describe and evaluate Herbal Medicine (HM) pharmacovigilance in African countries who are members of the WHO International Programme for Drug Monitoring a survey questionnaire was sent to the national centres and national drug regulatory agencies of these countries. Data collection was carried out from October 1st to 31st December, 2014. Among the total of 39 African countries, 34 (87.2%) answered the questionnaire and 25 (64.1%) accepted to share their data in this publication. Spontaneous adverse reaction reporting for HM is voluntary in 7 (43.7%) countries. HM pharmacovigilance programmes covered suspected adverse HM reactions in 14 (87.5%) countries; HM information in 7 (43.7%) countries; HM dependence or abuse in 6 (37.5%) countries; medication errors in 5 (31.2%) countries; falsification and adulteration in 2 (each 12.5%) countries and HM-drug interactions in 1 (6.3%) country. Groups in countries encouraged to submit herbal reports were pharmacists and physicians (both n=15); nurses (n=13); herbal therapists (n=12); patients (n=11) and local manufacturers (n=8). The number of herbal reports received by most countries was very low or even insignificant. VigiFlow is used by 10 countries. Information from pharmacovigilance activities is disseminated using many means. Only five countries have regulatory status and quality control of their HM products. The participants identified a need for HM regulation, technical and training assistance, and funding as being major challenges to HM pharmacovigilance in countries. Particular attention to the development of pharmacovigilance of HM is required in Africa.

  5. Role of Pharmacovigilance in India: An overview

    PubMed Central

    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

  6. Role of Pharmacovigilance in India: An overview.

    PubMed

    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

  7. Revisiting the reported signal of acute pancreatitis with rasburicase: an object lesson in pharmacovigilance

    PubMed Central

    Hauben, Manfred; Hung, Eric Y.

    2016-01-01

    Introduction: There is an interest in methodologies to expeditiously detect credible signals of drug-induced pancreatitis. An example is the reported signal of pancreatitis with rasburicase emerging from a study [the ‘index publication’ (IP)] combining quantitative signal detection findings from a spontaneous reporting system (SRS) and electronic health records (EHRs). The signal was reportedly supported by a clinical review with a case series manuscript in progress. The reported signal is noteworthy, being initially classified as a false-positive finding for the chosen reference standard, but reclassified as a ‘clinically supported’ signal. Objective: This paper has dual objectives: to revisit the signal of rasburicase and acute pancreatitis and extend the original analysis via reexamination of its findings, in light of more contemporary data; and to motivate discussions on key issues in signal detection and evaluation, including recent findings from a major international pharmacovigilance research initiative. Methodology: We used the same methodology as the IP, including the same disproportionality analysis software/dataset for calculating observed to expected reporting frequencies (O/Es), Medical Dictionary for Regulatory Activities Preferred Term, and O/E metric/threshold combination defining a signal of disproportionate reporting. Baseline analysis results prompted supplementary analyses using alternative analytical choices. We performed a comprehensive literature search to identify additional published case reports of rasburicase and pancreatitis. Results: We could not replicate positive findings (e.g. a signal or statistic of disproportionate reporting) from the SRS data using the same algorithm, software, dataset and vendor specified in the IP. The reporting association was statistically highlighted in default and supplemental analysis when more sensitive forms of disproportionality analysis were used. Two of three reports in the FAERS database were

  8. Utilizing Social Media Data for Pharmacovigilance: A Review

    PubMed Central

    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

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

    PubMed Central

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

    2017-01-01

    Background 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.” Objective 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. Methods 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. Results 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

  10. Use of Fibrates Monotherapy in People with Diabetes and High Cardiovascular Risk in Primary Care: A French Nationwide Cohort Study Based on National Administrative Databases

    PubMed Central

    Roussel, Ronan; Chaignot, Christophe; Weill, Alain; Travert, Florence; Hansel, Boris; Marre, Michel; Ricordeau, Philippe; Alla, François; Allemand, Hubert

    2015-01-01

    Background and Aim According to guidelines, diabetic patients with high cardiovascular risk should receive a statin. Despite this consensus, fibrate monotherapy is commonly used in this population. We assessed the frequency and clinical consequences of the use of fibrates for primary prevention in patients with diabetes and high cardiovascular risk. Design Retrospective cohort study based on nationwide data from the medical and administrative databases of French national health insurance systems (07/01/08-12/31/09) with a follow-up of up to 30 months. Methods Lipid-lowering drug-naive diabetic patients initiating fibrate or statin monotherapy were identified. Patients at high cardiovascular risk were then selected: patients with a diagnosis of diabetes and hypertension, and >50 (men) or 60 (women), but with no history of cardiovascular events. The composite endpoint comprised myocardial infarction, stroke, amputation, or death. Results Of the 31,652 patients enrolled, 4,058 (12.8%) received a fibrate. Age- and gender-adjusted annual event rates were 2.42% (fibrates) and 2.21% (statins). The proportionality assumption required for the Cox model was not met for the fibrate/statin variable. A multivariate model including all predictors was therefore calculated by dividing data into two time periods, allowing Hazard Ratios to be calculated before (HR<540) and after 540 days (HR>540) of follow-up. Multivariate analyses showed that fibrates were associated with an increased risk for the endpoint after 540 days: HR<540 = 0.95 (95% CI: 0.78–1.16) and HR>540 = 1.73 (1.28–2.32). Conclusion Fibrate monotherapy is commonly prescribed in diabetic patients with high cardiovascular risk and is associated with poorer outcomes compared to statin therapy. PMID:26398765

  11. Pharmacovigilance in Clinical Trials: Current Practice and Challenges.

    PubMed

    Cheaib, N

    2016-01-01

    In view of the MENA increasing participation in multinational trials and the increasing number of national/regional trials, this article explores potential areas of pharmacovigilance, requiring reform and provides recommendations for building a robust safety reporting system. Regulatory silence on expedited reporting requirements creates confusion for local sites that are part of multinational trials. Not allowing waiver for serious adverse events that are protocol specified or are study endpoints, along with lack of emphasis on causality as reporting criteria, adds substantial burden of uninformative cases for regulatory review. Despite global focus on Development Safety Update Report, local regulators are not yet insistent on real-time update of a drug's cumulative safety profile. Issues like reporting requirements for generic trials, pregnancy reporting and lenient timeline for death/life-threatening events need attention. Finally, the need to formulate an all-encompassing local pharmacovigilance guideline, in sync with global practice cannot be overemphasized.

  12. Pharmacovigilance and Moroccan Tuberculosis Public Program: Current Situation

    PubMed Central

    Soussi Tanani, Driss; Tebaa, Amina; Benkirane, Raja; Bennani, Kenza; Iraqi, Ghali; Soulaymani, Abdelmajid; Soulaymani Bencheikh, Rachida

    2014-01-01

    The objective of this work is to demonstrate the interest of integration of pharmacovigilance in Moroccan Tuberculosis Control Program (MTCP). Design and Data Collection. The integration of pharmacovigilance in MTCP was conducted in October 2012 with the Global Fund support. We compared the reports notified before and after this integration (period 1: January 2010–October 2012; period 2: October 2012–December 2013). The detection of signals was based on the Information Component available in VigiMine. We used the SPSS version 10.0 and MedCalc version 7.3 for data analysis. Results. The average number of spontaneous reports increased from 3.6 to 37.4 cases/month (P < 10−3). The average age was 40.7 ± 17.5 years; the sex ratio was 0.8. Hepatic reactions (32.7%) predominated during the first period, while skin reactions (24.1%) were in the second period (P = 10−4), and 40.9% of cases in the first period were serious against 15.8% in second period (P = 0.003). Nine signals were generated (hepatic enzyme increase, cholestasis, jaundice, arthralgia, acne, lower limb edema, pruritus, skin rashes, and vomiting). Conclusion. The integration of pharmacovigilance in Moroccan Tuberculosis Control Program improved the management of ADRs and detected new signals of antituberculosis drugs. PMID:25013729

  13. Teaching French.

    ERIC Educational Resources Information Center

    Marty, Fernand

    This comprehensive analysis of French teaching methodology reveals basic problems underlying the current philosophy of language learning, while presenting new ideas based on extensive research. Two books, "Active French; Dialogues" and "Active French: Foundations Course" (Books 1 and 2), which stress well specified learning objectives, were…

  14. Developing a Crowdsourcing Approach and Tool for Pharmacovigilance Education Material Delivery.

    PubMed

    Bate, Andrew; Beckmann, Jürgen; Dodoo, Alexander; Härmark, Linda; Hartigan-Go, Kenneth; Hegerius, Anna; Lindquist, Marie; van Puijenbroek, Eugène; Tuccori, Marco; Hagemann, Ulrich

    2017-03-01

    The number of pharmacovigilance professionals worldwide is increasing with a high staff turnover. There is a constant stream of new colleagues with an interest or need to learn about the discipline. Consequently, there is an increasing need for training in pharmacovigilance. An important step towards this has been made through developing and publishing the World Health Organization (WHO)-International Society of Pharmacovigilance (ISoP) Pharmacovigilance Curriculum. Using the Pharmacovigilance Curriculum effectively, it should be supplemented by providing comprehensive training material from various sources, and making the Pharmacovigilance Curriculum attractive and a high-utility product. We describe a pilot of the development and initial evaluation of a crowdsourcing tool for the provision of pharmacovigilance education material. Pharmacovigilance experts shared links to their material to sections of relevance in the hierarchy and a small group of organisations conducted an initial testing. In this pilot, we have shown the usability of such a web-based tool. The strengths of this approach include the potential for a routine 'democratic' approach to sharing educational material to a wider community and an openness for access.

  15. Pharmacovigilance amongst patent medicine vendors (PMVs) in Ekiti state, Nigeria.

    PubMed

    Awodele, Olufunsho; Adeniran, Adeyinka; Awodele, Deborah F

    2012-01-01

    With the current population of Nigeria and the limited number of trained health care providers, PMVs are inevitable and highly needed especially in the rural areas for the supply of drugs in treating minor illnesses. Thus, pharmacovigilance (PVG) activity in Nigeria cannot exclude the roles of PMVs; therefore, this study was aimed to determine the knowledge of PMVs on PVG and adverse drug reaction reporting system. The study was a descriptive cross-sectional survey of the knowledge of Pharmacovigilance and adverse drug reaction reporting system of 96 PMVs in Ekiti state, Nigeria before the National Pharmacovigilance training in February, 2011 and after the training. The data obtained before the training showed that more than 87% of the respondents had at least secondary level of education. About half of the respondents (58.5%) knew the correct meaning of PVG and 56.6% knew how to report ADRs. But only about one third of them (35.8%) knew where to obtain ADR forms. Very few respondents 3 (5.7%) had received report/complaints of ADR from patients in the last 1 month while just 2 (3.8%) of them reported. The most commonly mentioned factors/reasons for poor reporting of ADRs/compliance with PVG guideline by the respondents were fears of indictment (61.3%), poor public knowledge (88.7%), and poor training on PMVs (92.5%). However, the results after the training showed a statistically significant (p ≤ 0.005) improvement in the proportion of respondents who were aware of PVG (from 55.8% to 89.1%), those who knew the meaning of PVG (from 49.0% to 61.7%), where to obtain ADR form (28.3% to 92.1%) and those who knew how to report ADRs (44.2% to 88.0%). PMVs are ready to practice PVG if they are properly trained. Training has been revealed to play a significant role in the knowledge of the concept of PVG amongst PMVs. It is therefore recommended that National Pharmacovigilance Centre should continue to organize periodic trainings for PMVs especially those with poor

  16. Joint medicine-information and pharmacovigilance services could improve detection and communication about drug-safety problems

    PubMed Central

    Schjøtt, Jan; Bergman, Jenny

    2014-01-01

    Background RELIS is a Norwegian network of four regional medicine-information and pharmacovigilance centers where pharmacists and clinical pharmacologists provide feedback to health care professionals in spontaneous drug-related questions and adverse drug-reaction (ADR) reports published in a question–answer pair (QAP) database (the RELIS database) and the Norwegian ADR database, respectively. Objective To describe the potential of RELIS’s dual service to improve detection and communication of drug-safety problems. Materials and methods We searched the RELIS database for QAPs about ADRs with use of the Norwegian ADR database as a reference. We also searched the Norwegian ADR database for reports that used the RELIS database as a reference. Both searches were limited to the years 2003–2012. We then selected the example of pregabalin and drug abuse after the marketing of Lyrica in Norway in September 2004 to illustrate RELIS’s potential to detect new drug-safety information through a limited number of QAPs and ADR reports. Results A total of 5,427 (26%) of 21,071 QAPs in the RELIS database concerned ADRs. QAPs from this database were used as references in 791 (4%) of a total of 22,090 reports in the Norwegian ADR database. The Norwegian ADR database was used as a reference in 363 (7%) of 5,427 QAPs that concerned ADRs. Between September 2004 and September 2008, RELIS received eleven questions and 13 ADR reports about suspicion of Lyrica (pregabalin) and different aspects of abuse. Conclusion RELIS processes data through two databases that facilitate communication about ADRs. Our service also has the potential to detect new drug-safety problems with a limited number of questions and ADR reports. PMID:25061339

  17. [Importance of pharmacovigilance in current medical practice].

    PubMed

    Ponte, Marcelo L; Ragusa, Martín; Armenteros, Christian; Wachs, Adolfo

    2013-01-01

    Adverse drug reactions (ADRs) are cause of significant morbi-mortality They are between the fourth and sixth cause of mortality in developed countries and cause nearly 12% of hospitalizations. The objective of this publication was to analyze the incidence of ADRs in a tertiary care hospital in Buenos Aires City. The hospital phamacovigilance database for the period June 2008- February 2012, was analyzed. The Naranjo score was applied to assess drug causality. We consider serious an ADRs when it potentially compromised life, induced hospitalization or prolonged it, caused discapacity, teratogenesis or death. In this period, a total of 2420 ADRs were detected: 469 (19.38%; CI 95%: 17.80 - 20.95) were serious, mainly because they induced hospitalization (n = 287). There were 14 ADRs- related deaths. Cardiovascular and neuropsychiatric drugs, antibiotics and corticoids were those most frequently related to toxicity. Endocrine-metabolic disorders, hepatotoxicity, nephrotoxicity and pharmacodermy were the most frequently involved. Among the ADR most frequently associated to hospitalization were Immunosuppressant-associated severe infections and upper gastrointestinal bleeding related to oral anticoagulants and non steroids anti-inflammatory drugs. The ADRs incidence in hospitalized patients and ADRs related hospital admissions were considered relatively high. Drugs involved were similar to those reported in the international bibliography except for the higher incidence of immunosuppressants related admissions here observed.

  18. Pharmacovigilance amongst doctors in private hospitals in Lagos West Senatorial District, Nigeria.

    PubMed

    Awodele, Olufunsho; Akinyede, Akinwumi; Adeyemi, Oladunni Adejoke; Awodele, Deborah Funmilola

    2011-01-01

    Appropriate practice of pharmacovigilance in Nigeria will require total involvement of the private medical practitioners considering their number and closeness to the community. Thus, the understanding and attitude of Doctors practicing in the private sectors, towards Pharmacovigilance, was investigated. A consecutive sampling was used to distribute two hundred and seventy questionnaires to consenting doctors in the private hospitals of the Lagos West Senatorial District. The response rate was 93% and the results showed that majority of the respondents, 208 (82.9%), have heard about pharmacovigilance and a large percentage (79.3%) defined pharmacovigilance correctly. However, most of the respondents, 141 (56.2%), did not know how to report ADRs and where to obtain the ADR forms (71.7%). Only 14 (5.6%) of the respondents reported ADRs in the last one month. However, the majority of the respondents (89.6%) were willing to practice pharmacovigilance if they are trained. There were significant associations (p < 0.05) between previous areas of practice of the respondents; the respondents' academic qualifications; years of experience and reporting of ADRs. The NPC has already been organizing series' of trainings for doctors on pharmacovigilance, however, more periodic trainings should be organized for doctors especially those practicing in private hospitals. The curriculum of medical schools should be reviewed for its pharmacovigilance content.

  19. [Use abusive of benzydamine in Brazil: an overview in pharmacovigilance].

    PubMed

    Mota, Daniel Marques; Costa, Alessandra Alves da; Teixeira, Christiane Dos Santos; Bastos, Augusto Amorim; Dias, Murilo Freitas

    2010-05-01

    The abusive drug use has been object of increasing concern in public health and is commonly issued in the Brazilian press. Amongst medicines, those that are abuse substances and cause physical and/or psychic dependence, barbiturates, benzodiazepines, opioid analgesics and amphetamines are included. Analgesics, antipyretics and non-steroidal anti-inflammatory drugs, even not making part of this list, are generally associated with recreational use or non therapeutical purpose. The objective of this essay is to present information on the abusive use of benzydamine in Brazil. The present study is an exploratory essay in which different methodological strategies adopted in the regulatory practice of pharmacovigilance have been used. The abusive use of this drug was evidenced in scientific literature, press releases and on the internet. Considering the facility of purchasing drugs under medical prescription, among other factors, it must be demanded ways to assess the marketing and use of medicines, and assure its safe and rational use, including the strengthening of pharmacovigilance in Brazil.

  20. Pharmacovigilance in veterinary medicine in Chile: a pilot study.

    PubMed

    Iragüen, D; Urcelay, S; San Martín, B

    2011-04-01

    Iragüen, D., Urcelay, S., San Martín, B. Pharmacovigilance in veterinary medicine in Chile: a pilot study. J. vet. Pharmacol. Therap.34, 108-115. In Chile, there is no present government policy to survey and analyse adverse drug reactions (ADRs) in the field of veterinary medicine. The intent of this study is to assess, for the first time, ADR frequency in treated animals. To this purpose, a 6-month period pilot study based on WHO recommendations was conducted to monitor ADRs in cats and dogs for frequently used drugs and common labelled signs. Of a total of 149 detected ADRs, 29 (6 in cats and 23 in dogs) were notified by means of ADR report forms, while the rest was identified after reviewing patient clinical records, thus evidencing strong under-reporting problems. More than 70% of ADRs were related to antimicrobials, vaccines and tranquilizers. In dogs, there was a significant effect on ADRs' presentation when acepromazine, amoxicillin, carprofen, ivermectin, sextuple vaccine (polyvalent vaccine that confers immunity against canine distemper virus, canine parvovirus, Leptospira canicola, L. icterohemmoragiae, canine adenovirus type 2 and canine parainfluenza virus) and phytomenadione (subcutaneous injection) were administered. In the case of cats, a significant influence on ADRs was detected when acepromazine, amoxicillin or vitamin K was administered. Present results suggest the need for a pharmacovigilance programme in veterinary medicine for timely ADR-presenting drug detection and drug safety improvement.

  1. CIOMS and ICH initiatives in pharmacovigilance and risk management: overview and implications.

    PubMed

    Tsintis, Panos; La Mache, Edith

    2004-01-01

    In this article we review the current initiatives by the Council for International Organizations of Medical Sciences (CIOMS) and the International Conference on Harmonisation (ICH) on pharmacovigilance planning that are due for general release during 2004. These initiatives could form the basis for applying concepts of risk management to medicines throughout their life cycle, from preclinical and clinical development to marketed use. The CIOMS VI Working Group (with 28 senior scientists worldwide from drug regulatory authorities and pharmaceutical companies) is currently developing scientific guidance that relates to clinical trials for medicines during development. It recommends a developmental pharmacovigilance concept - a 'living' concept that would start early in drug development supporting the science and ethics of research leading up to licensing (marketing authorisation) and continuing to post-authorisation (postmarketing) pharmacovigilance. This approach is seen as complementary to current ICH initiatives called 'Pharmacovigilance Planning'. ICH will introduce two concepts in pharmacovigilance management of medicinal products: the 'Pharmacovigilance Specification' and the 'Pharmacovigilance Plan'. The 'Pharmacovigilance Specification' will summarise important knowns and unknowns about the medicine. It will include safety risks identified at the licensing stage, potential risks and any key missing information. These elements will be essential to the formulation of pharmacovigilance plans. Dialogue and common understanding between regulators and the pharmaceutical industry will be a key factor for developing pharmacovigilance plans during the life cycle of medicines. Appropriate interaction with health professionals and patients should also be planned for the future as regulatory systems become more transparent. Where no significant issues are apparent at the licensing (marketing authorisation) stage, routine pharmacovigilance practices will be followed

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

    PubMed Central

    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

    2013-01-01

    Introduction: 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. Materials and Methods: 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. Results: 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. Conclusions: 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. PMID:24347984

  3. The Mini Mental State Examination at the Time of Alzheimer's Disease and Related Disorders Diagnosis, According to Age, Education, Gender and Place of Residence: A Cross-Sectional Study among the French National Alzheimer Database

    PubMed Central

    Pradier, Christian; Sakarovitch, Charlotte; Le Duff, Franck; Layese, Richard; Metelkina, Asya; Anthony, Sabine; Tifratene, Karim; Robert, Philippe

    2014-01-01

    The aim of this study was firstly to describe the MMSE (Mini-Mental State Examination) score upon initial diagnosis of Alzheimer's disease and related disorders among the French population, according to age. Secondly, education, gender and place of residence were studied as factors potentially associated with delayed Alzheimer's disease diagnosis. Design we conducted a cross sectional analysis of the French National Alzheimer database (BNA). Data from 2008 to 2012 were extracted. Patients were selected at the moment of their first diagnosis of AD (n = 39,451). Results The MMSE score at initial diagnosis dropped significantly with increasing age. The test score increased with the degree of educational background regardless of age. Gender and place of residence were significantly related to the MMSE score, women and persons living in medical institutions having lower MMSE scores under the age of 90 years and at all educational levels. Conclusions Health care professionals should be aware of these risk factors in order to maximize chances of earliest possible diagnosis of Alzheimer's disease and related disorders. PMID:25093735

  4. The periodic safety update report as a pharmacovigilance tool.

    PubMed

    Klepper, Michael J

    2004-01-01

    The periodic safety update report for marketed drugs (PSUR) was designed to be a stand-alone document that allows a periodic but comprehensive assessment of the worldwide safety data of a marketed drug or biological product. The PSUR can be an important source for the identification of new safety signals, a means of determining changes in the benefit-risk profile, an effective means of risk communication to regulatory authorities and an indicator for the need for risk management initiatives, as well as a tracking mechanism monitoring the effectiveness of such initiatives. For these reasons, the PSUR can be an important pharmacovigilance tool. Numerous steps are involved in the PSUR process including: intake of adverse drug reaction information, case processing, data retrieval, data analysis, and medical review and risk assessment. These processes are heavily reliant on the availability of adequate resources. An overarching principle throughout the PSUR process is the need for a proactive approach in order to identify the critical steps in the process and to have a clear understanding of the consequences of any critical 'mis-step'. With this information comes appropriate planning, building quality into each step of the PSUR process and monitoring performance will maximise the likelihood of generating a quality report. Any failure of a key PSUR process will have the opposite effect - a poor quality report that will give little insight into emerging safety signals or provide misleading information that can adversely affect public health. A pragmatic approach that will avoid or minimise these pitfalls includes the following: adequate resource planning, training, development of 'scripts' designed to maximise the capture of key information for medically important reactions, standardised and harmonised Medical Dictionary for Regulatory Activities (MedDRA) coding procedures, pre-specified search criteria for data retrieval, ongoing medical review, and metrics to evaluate

  5. Data mining in pharmacovigilance: the need for a balanced perspective.

    PubMed

    Hauben, Manfred; Patadia, Vaishali; Gerrits, Charles; Walsh, Louisa; Reich, Lester

    2005-01-01

    Data mining is receiving considerable attention as a tool for pharmacovigilance and is generating many perspectives on its uses. This paper presents four concepts that have appeared in various professional venues and represent potential sources of misunderstanding and/or entail extended discussions: (i) data mining algorithms are unvalidated; (ii) data mining algorithms allow data miners to objectively screen spontaneous report data; (iii) mathematically more complex Bayesian algorithms are superior to frequentist algorithms; and (iv) data mining algorithms are not just for hypothesis generation. Key points for a balanced perspective are that: (i) validation exercises have been done but lack a gold standard for comparison and are complicated by numerous nuances and pitfalls in the deployment of data mining algorithms. Their performance is likely to be highly situation dependent; (ii) the subjective nature of data mining is often underappreciated; (iii) simpler data mining models can be supplemented with 'clinical shrinkage', preserving sensitivity; and (iv) applications of data mining beyond hypothesis generation are risky, given the limitations of the data. These extended applications tend to 'creep', not pounce, into the public domain, leading to potential overconfidence in their results. Most importantly, in the enthusiasm generated by the promise of data mining tools, users must keep in mind the limitations of the data and the importance of clinical judgment and context, regardless of statistical arithmetic. In conclusion, we agree that contemporary data mining algorithms are promising additions to the pharmacovigilance toolkit, but the level of verification required should be commensurate with the nature and extent of the claimed applications.

  6. Health Professionals' Knowledge, Attitudes and Practices about Pharmacovigilance in India: A Systematic Review and Meta-Analysis

    PubMed Central

    Bhagavathula, Akshaya Srikanth; Elnour, Asim Ahmed; Jamshed, Shazia Qasim; Shehab, Abdulla

    2016-01-01

    Background Spontaneous or voluntary reporting of suspected adverse drug reactions (ADRs) is one of the vital roles of all health professionals. In India, under-reporting of ADRs by health professionals is recognized as one of the leading causes of poor ADR signal detection. Therefore, reviewing the literature can provide a better understanding of the status of knowledge, attitude and practice (KAP) of Pharmacovigilance (PV) activities by health professionals. Methods A systematic review was performed through Pubmed, Scopus, Embase and Google Scholar scientific databases. Studies pertaining to KAP of PV and ADR reporting by Indian health professionals between January 2011 and July 2015 were included in a meta-analysis. Results A total of 28 studies were included in the systematic review and 18 of them were selected for meta-analysis. Overall, 55.6% (95% CI 44.4–66.9; p<0.001) of the population studied were not aware of the existence of the Pharmacovigilance Programme in India (PvPI), and 31.9% (95% CI 16.3–47.4; p<0.001) thought that "all drugs available in the market are safe". Furthermore, 28.7% (95% CI 16.4–40.9; p<0.001) of them were not interested in reporting ADRs and 74.5%, (95% CI 67.9–81.9; p<0.001) never reported any ADR to PV centers. Conclusion There was an enormous gap of KAP towards PV and ADR reporting, particularly PV practice in India. There is therefore an urgent need for educational awareness, simplification of the ADR reporting process, and implementation of imperative measures to practice PV among healthcare professionals. In order to understand the PV status, PvPI should procedurally assess the KAP of health professionals PV activities in India. PMID:27010447

  7. Safety monitoring of herb-drug interactions: a component of pharmacovigilance.

    PubMed

    Skalli, Souad; Soulaymani Bencheikh, Rachida

    2012-10-01

    Adverse drug reactions, including those resulting from interactions between herbal medicines and conventional drugs, are a public health problem worldwide. The need for pharmacovigilance for herb-drug interactions (HDIs) is essential for the identification and assessment of risks of using herbal products (questionable safety, efficacy and quality), which are not always tested with rigor, or often not subject to approval by regulatory agencies. Spontaneous and active surveillance conducted by national pharmacovigilance centres permits a rapid detection of potentially harmful combinations of products. The incidence and prevalence of HDIs are difficult to predict because of the underreporting of adverse effects. It is important for health professionals, consumers, regulatory authorities and suppliers of herbal medicines to be aware of the possible adverse effects and drug interactions caused when herbal medicines are co-administered with conventional drugs. National pharmacovigilance centres continue to play a significant role in increasing awareness of drug safety, in this case with HDIs. The authors' objective for this paper is to provide awareness among policy makers responsible for the design of appropriate pharmacovigilance practices and therefore to highlight the importance of pharmacovigilance in the safety monitoring of HDIs.

  8. Implementing a centralised pharmacovigilance service in a non-commercial setting in the United Kingdom.

    PubMed

    Dinnett, Eleanor M; Kean, Sharon; Tolmie, Elizabeth P; Ronald, Elizabeth S; Gaw, Allan

    2013-06-12

    The implementation of a pharmacovigilance service compliant with the legal and regulatory responsibilities of clinical trial sponsors presents particular challenges for sponsors in a non-commercial setting.In this paper we examine these challenges in detail. We identify and discuss the key steps in the development of a pharmacovigilance service within a public health service and university setting in the United Kingdom. We describe how we have established a central Pharmacovigilance Office with dedicated staff and resources within our organisation. This office is supported by an electronic pharmacovigilance reporting infrastructure developed to facilitate the receipt and processing of safety information, the onward reporting in compliance with legislation and the provision of sponsor institution oversight of clinical trial participant safety. An education and training programme has also been set up to ensure that all relevant staff in the organisation are fully aware of the pharmacovigilance service and are appropriately trained in its use.We discuss possible alternatives to this approach and why we consider our solution to be the most appropriate to ensure that a non-commercial sponsor organisation and investigators are operating in a fully compliant way.

  9. Pharmacovigilance on Twitter? Mining Tweets for Adverse Drug Reactions

    PubMed Central

    O’Connor, Karen; Pimpalkhute, Pranoti; Nikfarjam, Azadeh; Ginn, Rachel; Smith, Karen L; Gonzalez, Graciela

    2014-01-01

    Recent research has shown that Twitter data analytics can have broad implications on public health research. However, its value for pharmacovigilance has been scantly studied – with health related forums and community support groups preferred for the task. We present a systematic study of tweets collected for 74 drugs to assess their value as sources of potential signals for adverse drug reactions (ADRs). We created an annotated corpus of 10,822 tweets. Each tweet was annotated for the presence or absence of ADR mentions, with the span and Unified Medical Language System (UMLS) concept ID noted for each ADR present. Using Cohen’s kappa1, we calculated the inter-annotator agreement (IAA) for the binary annotations to be 0.69. To demonstrate the utility of the corpus, we attempted a lexicon-based approach for concept extraction, with promising success (54.1% precision, 62.1% recall, and 57.8% F-measure). A subset of the corpus is freely available at: http://diego.asu.edu/downloads. PMID:25954400

  10. Pharmacovigilance, risks and adverse effects of self-medication.

    PubMed

    Montastruc, Jean-Louis; Bondon-Guitton, Emmanuelle; Abadie, Delphine; Lacroix, Isabelle; Berreni, Aurélia; Pugnet, Grégory; Durrieu, Geneviève; Sailler, Laurent; Giroud, Jean-Paul; Damase-Michel, Christine; Montastruc, François

    2016-04-01

    Self-medication means resorting to one or more drugs in order to treat oneself without the help of a doctor. This phenomenon is developing fast. In this review, we will discuss the main definitions of self-medication; we will then present a few important characteristics of this therapeutic practice: prevalence, reasons, populations involved and drugs used. Whilst the theoretical risks of self-medication have been abundantly discussed in the literature (adverse effects, interactions, product, dosage or treatment duration errors, difficulty in self-diagnosis, risk of addiction or abuse…), there is in fact very little detailed pharmacovigilance data concerning the characteristics and the consequences of this usage in real life. This study therefore describes the all too rare data that is available: patients, clinical characteristics, "seriousness" and drugs involved in the adverse effects of self-medication. It also discusses leads to be followed in order to minimize medication risks, which are obviously not well known and clearly not sufficiently notified.

  11. A Multiagent System for Integrated Detection of Pharmacovigilance Signals.

    PubMed

    Koutkias, Vassilis; Jaulent, Marie-Christine

    2016-02-01

    Pharmacovigilance is the scientific discipline that copes with the continuous assessment of the safety profile of marketed drugs. This assessment relies on diverse data sources, which are routinely analysed to identify the so-called "signals", i.e. potential associations between drugs and adverse effects, that are unknown or incompletely documented. Various computational methods have been proposed to support domain experts in signal detection. However, recent comparative studies illustrated that current methods exhibit high false-positive rates, significantly variable performance across different datasets used for analysis and events of interest, but also complementarity in their outcomes. In this regard, in order to reinforce accurate and timely signal detection, we elaborated through an agent-based approach towards systematic, joint exploitation of multiple heterogeneous signal detection methods, data sources and other drug-related resources under a common, integrated framework. The approach relies on a multiagent system operating based on a collaborative agent interaction protocol, aiming to implement a comprehensive workflow that comprises of method selection and execution, as well as outcomes' aggregation, filtering, ranking and annotation. This paper presents the design of the proposed multiagent system, discusses implementation issues and demonstrates the applicability of the proposed solution in an example signal detection scenario. This work constitutes a step towards large-scale, integrated and knowledge-intensive computational signal detection.

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

    PubMed Central

    2010-01-01

    Background 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. Methods 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. Results 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. Conclusions There were relatively few requests for funding for pharmacovigilance activities, demonstrating a lack of emphasis placed on pharmacovigilance systems in recipient countries. The

  13. In-Hospital Economic Burden of Metastatic Renal Cell Carcinoma in France in the Era of Targeted Therapies: Analysis of the French National Hospital Database from 2008 to 2013

    PubMed Central

    2016-01-01

    Background & Objectives The aim of this study was to assess the economic burden of hospitalisations for metastatic renal cell carcinoma (mRCC), to describe the patterns of prescribing expensive drugs and to explore the impact of geographic and socio-demographic factors on the use of these drugs. Methods We performed a retrospective analysis from the French national hospitals database. Hospital stays for mRCC between 2008 and 2013 were identified by combining the 10th revision of the International Classification of Diseases (ICD-10) codes for renal cell carcinoma (C64) and codes for metastases (C77 to C79). Incident cases were identified out of all hospital stays and followed till December 2013. Descriptive analyses were performed with a focus on hospital stays and patient characteristics. Costs were assessed from the perspective of the French National Health Insurance and were obtained from official diagnosis-related group tariffs for public and private hospitals. Results A total of 15,752 adult patients were hospitalised for mRCC, corresponding to 102,613 hospital stays. Of those patients, 68% were men and the median age at first hospitalisation was 69 years [Min-Max: 18–102]. Over the study period, the hospital mortality rate reached 37%. The annual cost of managing mRCC at hospital varied between 28M€ in 2008 and 42M€ in 2012 and was mainly driven by inpatient costs. The mean annual per capita cost of hospital management of mRCC varied across the study period from 8,993€ (SD: €8,906) in 2008 to 10,216€ (SD: €10,527) in 2012. Analysis of the determinants of prescribing expensive drugs at hospital did not show social or territorial differences in the use of these drugs. Conclusion This study is the first to investigate the in-hospital economic burden of mRCC in France. Results showed that in-hospital costs of managing mRCC are mainly driven by expensive drugs and inpatient costs. PMID:27649305

  14. The knowledge, attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital

    PubMed Central

    Vural, Fisun; Ciftci, Seval; Vural, Birol

    2015-01-01

    OBJECTIVE: With the use of any drug comes the possibility of unintended consequences which when harmful are referred to as adverse drug reactions (ADRs). The development of national pharmacovigilance systems is the responsibility of all health workers. The aim of this study was to investigate the knowledge of nurses about pharmacovigilance and attitudes about ADR and adverse event reporting. METHODS: This descriptive-cross sectional study was performed in 112 nurses working in a public hospital. The questionnaire was applied about pharmacovigilance and adverse drug reactions. The knowledge, attitudes and practices about adverse drug reactions were asked. RESULTS: The 74.1% of the nurses definition of “severe adverse effect” of drug therapy. The ratio of participants who knew that ADRs are reported to contact person responsible from pharmacovigilance was 34.9%. Although 70.5% of nurses knew the necessity of ADR reporting, the 8% of the nurses knew Turkish Pharmacovigilance Center (TÜFAM). Only 8% of nurses reported ADRs in their professionality. CONCLUSION: Although most of the participants knew the importance of ADR event reporting, event reporting was low. Thiese results showed that there is a lack of knowledge about pharmacovigilance. Futher studies with different settings and healthcare staff are needed to improve awareness about pharmacovigilance. PMID:28058321

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

    PubMed

    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.

  16. Pharmacovigilance-related topics at the level of the International Conference on Harmonisation (ICH).

    PubMed

    Bahri, Priya; Tsintis, Panos

    2005-06-01

    Marketing authorisations for medicines need to be based on the universal criteria quality, safety and efficacy, whilst taking into account local public health needs. With view to using resources efficiently and avoiding delay in access to medicines, scientific standards for investigating quality, safety and efficacy should be universal too. A major step to achieve this was taken in 1990 when the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was established between authorities and industry in the European Union (EU), Japan and the United States. Since then more than 50 ICH Guidelines have been published, out of which six are specific to pharmacovigilance. They refer to management and expedited reporting of individual adverse drug reaction (ADR) cases, including electronic formats, periodic reporting of worldwide data and planning of pharmacovigilance. Their development has to be seen in the context of initiatives taken in the three ICH Regions to strengthen pharmacovigilance. Most recently this involves making use of risk management concepts, reflecting new thinking of proactivity in pharmacovigilance. Moreover, consideration is given to regional and international cooperation beyond the ICH Regions.

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

    PubMed

    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.

  18. Pharmacovigilance implemented by patients: A necessity in the 21st century.

    PubMed

    Lafond, Jean

    2016-04-01

    Pharmacovigilance should become a well-thought-out reflex for each of us, for any drugs taken on prescription or by self-medication. The issue of pharmacovigilance should naturally take its place in the dialogue between patients and health professionals, through advice given before medication is taken. Patients need to be told the importance of notifying any adverse drug reactions (ADRs). Pharmacovigilance would then become a post-hoc way of protecting patients. The importance of using pharmacovigilance should be promoted by emphasizing the fact that the life of a drug really starts after its marketing. This state of mind could be reinforced by a wider advertising campaign on the possibility of notifying the relevant authorities of any ADRs. Patient associations should encourage and help their members to do this. Notifying any ADRs should become a concern for all medical and paramedical staff: those who prescribe drugs, those who dispense them (pharmacists or pharmacy assistants), those who administer them (nurses), but also the consumers (patients) whose place is becoming more and more prominent.

  19. Pharmacovigilance of herbal medicines: the potential contributions of ethnobotanical and ethnopharmacological studies.

    PubMed

    Rodrigues, Eliana; Barnes, Joanne

    2013-01-01

    Typically, ethnobotanical/ethnopharmacological (EB/EP) surveys are used to describe uses, doses/dosages, sources and methods of preparation of traditional herbal medicines; their application to date in examining the adverse effects, contraindications and other safety aspects of these preparations is limited. From a pharmacovigilance perspective, numerous challenges exist in applying its existing methods to studying the safety profile of herbal medicines, particularly where used by indigenous cultures. This paper aims to contribute to the methodological aspects of EB/EP field work, and to extend the reach of pharmacovigilance, by proposing a tool comprising a list of questions that could be applied during interview and observational studies. The questions focus on the collection of information on the safety profile of traditional herbal medicines as it is embedded in traditional knowledge, as well as on identifying personal experiences (spontaneous reports) of adverse or undesirable effects associated with the use of traditional herbal medicines. Questions on the precise composition of traditional prescriptions or 'recipes', their preparation, storage, administration and dosing are also included. Strengths and limitations of the tool are discussed. From this interweaving of EB/EP and pharmacovigilance arises a concept of ethnopharmacovigilance for traditional herbal medicines: the scope of EB/EP is extended to include exploration of the potential harmful effects of medicinal plants, and the incorporation of pharmacovigilance questions into EB/EP studies provides a new opportunity for collection of 'general' traditional knowledge on the safety of traditional herbal medicines and, importantly, a conduit for collection of spontaneous reports of suspected adverse effects. Whether the proposed tool can yield data sufficiently rich and of an appropriate quality for application of EB/EP (e.g. data verification and quantitative analysis tools) and pharmacovigilance

  20. French Teaching Aids.

    ERIC Educational Resources Information Center

    Miller, J. Dale

    Supplementary teaching materials for French language programs are presented in this text. Primarily intended for secondary school students, the study contains seven units of material. They include: (1) French gestures, (2) teaching the interrogative pronouns, (3) French cuisine, (4) recreational learning games, (5) French-English cognates, (6)…

  1. OpenVigil FDA – Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications

    PubMed Central

    Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

    2016-01-01

    Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs. PMID:27326858

  2. [Pharmacovigilance idea should be introduced sufficiently into the safety monitoring and evaluation process of Chinese drugs].

    PubMed

    Zhang, Li; Yang, Xiao-Hui

    2009-09-01

    Along with the general improving of public consciousness on drugs' safety and the increasing of new Chinese drugs' manufacture and application, the safety of Chinese drugs has become a more prominent concern and a focus of attention. The scientific identification, analysis and evaluation of this affairs greatly impacts the scientific decision-making for ensuring the public use of drugs in security, also influences the healthy development of Chinese medicine industry. In this paper, the different meanings of "adverse reaction" and "adverse events" of Chinese drugs were introduced from pharmacovigilance idealistic view, and the influencing factors on safety of Chinese drugs were analyzed from the perspective of pharmacovigilance. The authors proposed that "Chinese medicine safety monitoring and evaluation" is a much more practical concept in consistency with the current situation. They pointed out that introducing sufficiently the concept of pharmaco vigilance idea into the safety monitoring and evaluation process is the basis for overall evaluation and effective risk controlling of Chinese drugs.

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

    PubMed Central

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

    2015-01-01

    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. PMID:26147850

  4. [Misuse of drugs: conclusions of the pharmacovigilance workshops at La Baule, France].

    PubMed

    Fermont, I

    2002-01-01

    Drug iatrogeny is a current Public Health issue; it is often related to misuse and is therefore preventable. The congress "Les Ateliers de Pharmacovigilance de La Baule" (May 2001) bringing together pharmacovigilance staff from both the industry and Health authorities, showed that misuse concerns every step of the drug process--prescription, dispensing and administration--and all health professionals as well as the patient. New concepts have been brought to light with regard to the definition of misuse: the medical point of view should be preferred, based on the risk taken by a given patient without the expected benefit. product characteristics alone are inadequate and should be enlarged by relevent scientific data. the main goal is to improve the quality of healthcare by preventing misuse. A working group including Pharmacovigilance staff from the industry, the CRPV and the Afssaps has: to reach a consensus on definition in France and then propose it to EMEA; to analyse and propose specific prevention actions; to write a vademecum of those involved in this prevention.

  5. Towards a French Revolution

    ERIC Educational Resources Information Center

    Breach, H. T.

    1972-01-01

    Contends that secondary school students lose their appeal for French as they advance in school. Suggests that French teachers endeavor to motivate students by focusing more attention on their students and less on their own credentials. (DS)

  6. Why Study French?

    ERIC Educational Resources Information Center

    Bunge, Gerard

    This brochure for parents and prospective students of French points out career opportunities available to qualified speakers of French. Suggestions concerning student eligibility and the time requirements of language programs are also offered. (RL)

  7. The Verb-Lists of Modern French.

    ERIC Educational Resources Information Center

    Reed, J.

    1988-01-01

    Reviews and compares the main published repertoires of French verbs. By combining the material from these different sources, one can construct a database of approximately 10,300 formally distinct verbs. It is suggested that analysis of such a wide corpus may reveal structures not yet acknowledged. (Author/LMO)

  8. French Computer Terminology.

    ERIC Educational Resources Information Center

    Gray, Eugene F.

    1985-01-01

    Characteristics, idiosyncrasies, borrowings, and other aspects of the French terminology for computers and computer-related matters are discussed and placed in the context of French computer use. A glossary provides French equivalent terms or translations of English computer terminology. (MSE)

  9. Spoken French: Book One.

    ERIC Educational Resources Information Center

    Denoeu, Francois; Hall, R. A., Jr.

    This textbook offers a course in French designed for those who need to make themselves understood on ordinary topics in French and cannot devote years of study to the language. It is a self-instructional course, but it is designed to be used with a native French speaker as a guide or, if no native speaker is available, with recordings that are…

  10. French Studies: A Bibliography.

    ERIC Educational Resources Information Center

    Markey, William L., Comp.

    A bibliography of materials relating to French language and area studies includes citations of bibliographies, books, articles, and general and specialized reference materials in French and English in these categories: general reference guides; guides to French studies; style manuals; research methodology and handbooks; library resources;…

  11. Paediatric Pharmacovigilance: Use of Pharmacovigilance Data Mining Algorithms for Signal Detection in a Safety Dataset of a Paediatric Clinical Study Conducted in Seven African Countries

    PubMed Central

    Kajungu, Dan K.; Erhart, Annette; Talisuna, Ambrose Otau; Bassat, Quique; Karema, Corine; Nabasumba, Carolyn; Nambozi, Michael; Tinto, Halidou; Kremsner, Peter; Meremikwu, Martin; D’Alessandro, Umberto; Speybroeck, Niko

    2014-01-01

    Background Pharmacovigilance programmes monitor and help ensuring the safe use of medicines which is critical to the success of public health programmes. The commonest method used for discovering previously unknown safety risks is spontaneous notifications. In this study we examine the use of data mining algorithms to identify signals from adverse events reported in a phase IIIb/IV clinical trial evaluating the efficacy and safety of several Artemisinin-based combination therapies (ACTs) for treatment of uncomplicated malaria in African children. Methods We used paediatric safety data from a multi-site, multi-country clinical study conducted in seven African countries (Burkina Faso, Gabon, Nigeria, Rwanda, Uganda, Zambia, and Mozambique). Each site compared three out of four ACTs, namely amodiaquine-artesunate (ASAQ), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL) or chlorproguanil/dapsone and artesunate (CD+A). We examine two pharmacovigilance signal detection methods, namely proportional reporting ratio and Bayesian Confidence Propagation Neural Network on the clinical safety dataset. Results Among the 4,116 children (6–59 months old) enrolled and followed up for 28 days post treatment, a total of 6,238 adverse events were reported resulting into 346 drug-event combinations. Nine signals were generated both by proportional reporting ratio and Bayesian Confidence Propagation Neural Network. A review of the manufacturer package leaflets, an online Multi-Drug Symptom/Interaction Checker (DoubleCheckMD) and further by therapeutic area experts reduced the number of signals to five. The ranking of some drug-adverse reaction pairs on the basis of their signal index differed between the two methods. Conclusions Our two data mining methods were equally able to generate suspected signals using the pooled safety data from a phase IIIb/IV clinical trial. This analysis demonstrated the possibility of utilising clinical studies safety data for key

  12. Risk management plans as a tool for proactive pharmacovigilance: a cohort study of newly approved drugs in Europe.

    PubMed

    Vermeer, N S; Duijnhoven, R G; Straus, S M J M; Mantel-Teeuwisse, A K; Arlett, P R; Egberts, A C G; Leufkens, H G M; De Bruin, M L

    2014-12-01

    Risk Management Plans (RMPs) have become a cornerstone in the pharmacovigilance of new drugs in Europe. The RMP was introduced in 2005 to support a proactive approach in gaining knowledge on safety concerns through early planning of pharmacovigilance activities. However, the rate at which uncertainties in the safety profile are resolved through this proactive approach is unknown. We therefore examined the evolution of safety concerns in the RMP after initial approval for a selected cohort of 48 drugs, to provide insight into the knowledge gain over time. We found that 20.7% of the uncertainties existing at approval had been resolved 5 years after approval. Because new uncertainties were included in the RMP at a similar rate, the overall number of uncertainties remained approximately equal. The relatively modest accrual of knowledge, as demonstrated in this study through resolution of uncertainties, suggests that opportunities for optimization exist while ensuring feasible and risk-proportionate pharmacovigilance planning.

  13. Poststructuralism and the ARTFL Database: Some Theoretical Considerations.

    ERIC Educational Resources Information Center

    Wolff, Mark

    1994-01-01

    Describes textual database queries in the humanities based on poststructuralist theories and experiences with the ARTFL (American and French Research on the Treasury of the French Language) database. The use of computers for literary research and text interpretation and analysis is considered. (Contains nine references.) (LRW)

  14. Reevaluating the French Revolution.

    ERIC Educational Resources Information Center

    Stromberg, Roland N.

    1986-01-01

    Analyzes previous interpretations concerning the French Revolution. Discusses several weaknesses of the Marxist views in light of recent philosophical and sociological thinking about social change. (RKM)

  15. Pharmacovigilance in children: detecting adverse drug reactions in routine electronic healthcare records. A systematic review

    PubMed Central

    Black, Corri; Tagiyeva-Milne, Nara; Helms, Peter; Moir, Dorothy

    2015-01-01

    Aims A systematic review of the literature published in English over 10 years was undertaken in order to describe the use of electronic healthcare data in the identification of potential adverse drug reactions (ADRs) in children. Methods MEDLINE and EMBASE were searched using MESH headings and text words. Titles, keywords and abstracts were checked for age <18 years, potential ADRs and electronic healthcare data. Information extracted included age, data source, pharmacovigilance method, medicines and ADRs. Studies were quality assessed. Results From 14 804 titles, 314 had a full text review and 71 were included in the final review. Fifty were published in North America, 10 in Scandinavia. Study size ranged from less than 1000 children to more than 10 million. Sixty per cent of studies used data from one source. Comparative observational studies were most commonly reported (66.2%) with 15% using passive surveillance. Electronic healthcare data set linkage and the quality of the data source were poorly reported. ADRs were classified using the International Classification of Disease (ICD10). Multi-system reactions were most commonly studied, followed by central nervous system and mental and behavioural disorders. Vaccines were most frequently prescribed followed by corticosteroids, general anaesthetics and antidepressants. Conclusions Routine electronic healthcare records were increasingly reported to be used for pharmacovigilance in children. This growing and important health protection activity could be enhanced by consistent reporting of studies to improve the identification, interpretation and generalizability of the evidence base. PMID:25819310

  16. Skiing in French.

    ERIC Educational Resources Information Center

    Moeller, Paulette

    1984-01-01

    A high school French program conducted entirely in French on local ski slopes is based on the philosophy that language is a social tool for communicative purposes and can best be learned in social interaction. The successful program uses teamwork, an open attitude toward language learning, non-stressful evaluation, and innovative techniques. (MSE)

  17. The French Revolution.

    ERIC Educational Resources Information Center

    Baltimore City Public Schools, MD.

    This outline on the French Revolution is designed to illustrate how this period of French history influenced various aspects of contemporary culture. Four main sections are treated: (1) ideas that led to the Revolution, (2) the reigns of the Bourbon kings, (3) the Revolution, and (4) the rise of Napoleon as a reaction to chaos. A list of 16mm…

  18. Demythifying French Grammar.

    ERIC Educational Resources Information Center

    Bryant, William H.

    1984-01-01

    Focuses on several myths and fallacies prevalent in the field of French grammar. The importance of keeping up-to-date with language and grammatical usage is stressed, since the rules of language do change. Thus, the validity of the linguistic content of French grammar books must be questioned, so that any outmoded or invalid concepts can be…

  19. Illustrated French Idioms.

    ERIC Educational Resources Information Center

    Ainsa, Serge M.

    Designed to promote an awareness of the everyday French language, this supplementary textbook was developed to enable students of French to use idiomatic expressions from the early learning stages to the more advanced levels. The units are arranged as follows according to the verb component of the expression: "avoir,""etre,""faire," the three…

  20. Signal detection of methylphenidate by comparing a spontaneous reporting database with a claims database.

    PubMed

    Kim, JaYoung; Kim, Munsin; Ha, Ji-Hye; Jang, Junghoon; Hwang, Myungsil; Lee, Byung Koo; Chung, Myeon Woo; Yoo, Tae Moo; Kim, Myung Jung

    2011-11-01

    Data mining is critical for signal detection in pharmacovigilance systems. In this study, we compared signals between spontaneous reporting data and health insurance claims data for a socially issued drug, methylphenidate. We implemented data-mining tools for signal detection in both databases: Reporting Odds Ratios (ROR), Proportional Reporting Ratios (PRR), Chi-squared test, and Information Component (IC), in addition to a Relative Risk (RR) tool in the claims database. The claims database generated 15, 15, 36, 1, and 1 adverse drug reactions (ADRs) by ROR, PRR, chi-square, IC, and RR, respectively. The World Health Organization (WHO) spontaneous database generated 91, 91, 137, and 96 ADRs by ROR, PRR, chi-square, and IC, respectively. We found seven potential matching associations from the claims and WHO databases, but only one of them was present in the Korean spontaneous reporting database. In Korea, spontaneous reporting is still underreported and there is a small amount of data for Koreans. Signal comparison between the claims and WHO databases can provide additional regulatory insight.

  1. French for Business and Journalism

    ERIC Educational Resources Information Center

    Lacombe, Anne

    1977-01-01

    A description of a university course in French whose object is to give students some facility in current French as found in newspapers, magazines, radio and films; and to introduce them to contemporary French civilization. Methods used are reading, translation, synopsis writing, correspondence and interviews. (Text is in French.) (AMH)

  2. Teaching Middle School French

    ERIC Educational Resources Information Center

    Olson, Marilyn L.

    1975-01-01

    Author described some of the techniques she used for teaching French at Roosevelt Junior High School, West Palm Beach. She also explained how these techniques helped students to maintain an early desire to learn a foreign language. (Author/RK)

  3. [Evaluation of the website of the Nord-Pas-de-Calais regional pharmacovigilance center].

    PubMed

    Rochoy, Michaël; Béné, Johana; Messaadi, Nassir; Auffret, Marine; Gautier, Sophie

    2016-06-01

    We posted the Nord-Pas-de-Calais regional pharmacovigilance center website and distributed a survey to its potential users between August 2014 and October 2014 (135 general practitioners, 45 pharmacists, 14 patients). Satisfaction was 7.3±1.6 out of 10 points for the visual aspect, 7.8±1.5 out of 10 points for navigation and 7.6±1.4 out of 10 points for content. The website was declared useful by 98% respondents, particularly for the reporting of adverse drugs reactions (89%).

  4. The French Strategic Dilemma.

    DTIC Science & Technology

    1984-03-01

    crisis . The language of French strategic doctrine is that of dissuasion (deterrence). The French talk publicly much less about warfighting (and employment...threaten vital lines of supply in a crisis situation. Nuclear forces would not *-"e necessarily be useful In deterring Soviet actions in this regard. Rather...34 in Pierre Lellouche, ed., Pacifisme et Dissuasion (Paris: Economica , 1983), pp. 253-266. C. % 6. See Pierre Lacoste, Strategie Navale (Paris: Fernand

  5. Comparative analysis of pharmacovigilance methods in the detection of adverse drug reactions using electronic medical records

    PubMed Central

    Liu, Mei; McPeek Hinz, Eugenia Renne; Matheny, Michael Edwin; Denny, Joshua C; Schildcrout, Jonathan Scott; Miller, Randolph A; Xu, Hua

    2013-01-01

    Objective Medication  safety requires that each drug be monitored throughout its market life as early detection of adverse drug reactions (ADRs) can lead to alerts that prevent patient harm. Recently, electronic medical records (EMRs) have emerged as a valuable resource for pharmacovigilance. This study examines the use of retrospective medication orders and inpatient laboratory results documented in the EMR to identify ADRs. Methods Using 12 years of EMR data from Vanderbilt University Medical Center (VUMC), we designed a study to correlate abnormal laboratory results with specific drug administrations by comparing the outcomes of a drug-exposed group and a matched unexposed group. We assessed the relative merits of six pharmacovigilance measures used in spontaneous reporting systems (SRSs): proportional reporting ratio (PRR), reporting OR (ROR), Yule's Q (YULE), the χ2 test (CHI), Bayesian confidence propagation neural networks (BCPNN), and a gamma Poisson shrinker (GPS). Results We systematically evaluated the methods on two independently constructed reference standard datasets of drug–event pairs. The dataset of Yoon et al contained 470 drug–event pairs (10 drugs and 47 laboratory abnormalities). Using VUMC's EMR, we created another dataset of 378 drug–event pairs (nine drugs and 42 laboratory abnormalities). Evaluation on our reference standard showed that CHI, ROR, PRR, and YULE all had the same F score (62%). When the reference standard of Yoon et al was used, ROR had the best F score of 68%, with 77% precision and 61% recall. Conclusions Results suggest that EMR-derived laboratory measurements and medication orders can help to validate previously reported ADRs, and detect new ADRs. PMID:23161894

  6. Improving Detection of Arrhythmia Drug-Drug Interactions in Pharmacovigilance Data through the Implementation of Similarity-Based Modeling.

    PubMed

    Vilar, Santiago; Lorberbaum, Tal; Hripcsak, George; Tatonetti, Nicholas P

    2015-01-01

    Identification of Drug-Drug Interactions (DDIs) is a significant challenge during drug development and clinical practice. DDIs are responsible for many adverse drug effects (ADEs), decreasing patient quality of life and causing higher care expenses. DDIs are not systematically evaluated in pre-clinical or clinical trials and so the FDA U. S. Food and Drug Administration relies on post-marketing surveillance to monitor patient safety. However, existing pharmacovigilance algorithms show poor performance for detecting DDIs exhibiting prohibitively high false positive rates. Alternatively, methods based on chemical structure and pharmacological similarity have shown promise in adverse drug event detection. We hypothesize that the use of chemical biology data in a post hoc analysis of pharmacovigilance results will significantly improve the detection of dangerous interactions. Our model integrates a reference standard of DDIs known to cause arrhythmias with drug similarity data. To compare similarity between drugs we used chemical structure (both 2D and 3D molecular structure), adverse drug side effects, chemogenomic targets, drug indication classes, and known drug-drug interactions. We evaluated the method on external reference standards. Our results showed an enhancement of sensitivity, specificity and precision in different top positions with the use of similarity measures to rank the candidates extracted from pharmacovigilance data. For the top 100 DDI candidates, similarity-based modeling yielded close to twofold precision enhancement compared to the proportional reporting ratio (PRR). Moreover, the method helps in the DDI decision making through the identification of the DDI in the reference standard that generated the candidate.

  7. Translating Word-Play: French-English, English-French.

    ERIC Educational Resources Information Center

    Gordon, W. Terrence

    1986-01-01

    The linguistic complexity of humor is illustrated with examples of word play translated from French to English and English to French. Examples from the writings of James Joyce and Marcel Proust are highlighted. (CB)

  8. French Antilles and Guiana.

    PubMed

    1983-11-01

    This discussion of French Antilles and Guiana cover the following: the people, geography, history, government, political conditions, economy, and relations with the US. In 1983 the population totaled 303,000 with an annual growth rate of 0.09%. The infant mortality rate (1981) was 12.6/1000 and life expectancy 68 years. About 98% of the people of Martinique are of Afro European or Afro European Indian descent. The remainder are the old planter families and a sizable number of metropolitan French. Most of the work force are employed in agriculture or food processing and associated industries. Most permanent residents of Guadeloupe are of mixed Afro European descent. A few thousand Metropolitan French reside there. Most French Guianese live along the coast, about 1/2 of them in the capital. Martinique is the northernmost of the Windward Islands, which are part of the Lesser Antilles chain in the Caribbean Sea southeast of Puerto Rico. Guadeloupe comprises 2 of the Leeward Islands, which are also part of the Lesser Antilles chain. French Guiana is located on the northern coast of South America, a few degrees north of the Equator. Indians were the 1st known indigenous inhabitants of French Guiana and the French Antilles. Columbus sighted Guadeloupe in 1493, Martinique in 1493 or 1502, and the Guiana coast probably during his 3rd voyage in 1498. French Guiana, Guadeloupe, and Martinique, as overseas departments of France since 1946, are integral parts of the French Republic. Their relationship to Metropolitan France is somewhat similar to that of Alaska and Hawaii to the counterminous US. Each department has a general council composed of 1 representative elected by each canton. Guadeloupe and Martinique each elect 2 senators to the French Senate and 3 deputies to the National Assembly. French Guiana elects 1 senator and 1 deputy. In each of the 3 departments exist individuals and small political parties that advocate immediate independence, but their adherents form only

  9. The French Revolution and the French Language: A Paradox?

    ERIC Educational Resources Information Center

    Djite, Paulin

    1992-01-01

    Explores the relationship between revolutionary ideals and the subsequent expansion and promotion of the French language. It is shown, through a linguistic and sociopolitical history of the French Revolution and the French language, that there is no incompatibility between the two and that the movement of Francophonie is a continuation of France's…

  10. French for Marketing. Using French in Media and Communications.

    ERIC Educational Resources Information Center

    Batchelor, R. E.; Chebli-Saadi, M.

    The textbook, entirely in French, is designed to help prepare anglophone students for French language usage in the media and telecommunications. It is organized according to two major themes. The first part addresses the French of advertising; chapter topics include the actors in advertising (agencies, announcers, supports), forms of advertising,…

  11. Comparing Written Competency in Core French and French Immersion Graduates

    ERIC Educational Resources Information Center

    Lappin-Fortin, Kerry

    2014-01-01

    Few studies have compared the written competency of French immersion students and their core French peers, and research on these learners at a postsecondary level is even scarcer. My corpus consists of writing samples from 255 students from both backgrounds beginning a university course in French language. The writing proficiency of core French…

  12. French nuclear physics accelerator opens

    NASA Astrophysics Data System (ADS)

    Dumé, Belle

    2016-12-01

    A new €140m particle accelerator for nuclear physics located at the French Large Heavy Ion National Accelerator (GANIL) in Caen was inaugurated last month in a ceremony attended by French president François Hollande.

  13. Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil

    PubMed Central

    2013-01-01

    Background Adverse drug reactions (ADRs) are recognised as a common cause of hospital admissions, and they constitute a significant economic burden for hospitals. Hospital-based ADR monitoring and reporting programmes aim to identify and quantify the risks associated with the use of drugs provided in a hospital setting. This information may be useful for identifying and minimising preventable ADRs and may enhance the ability of prescribers to manage ADRs more effectively. The main objectives of this study were to evaluate ADRs that occurred during inpatient stays at the Hospital Geral de Palmas (HGP) in Tocantins, Brazil, and to facilitate the development of a pharmacovigilance service. Methods A prospective study was conducted at HGP over a period of 8 months, from January 2009 to August 2009. This observational, cross-sectional, descriptive study was based on an analysis of medical records. Several parameters were utilised in the data evaluation, including patient demographics, drug and reaction characteristics, and reaction outcomes. The reaction severity and predisposing factors were also assessed. Results The overall incidence of ADRs in the patient population was 3.1%, and gender was not found to be a risk factor. The highest ADR rate (75.8%) was found in the adult age group 15 to 50 years, and the lowest ADR rate was found in children aged 3 to 13 years (7.4%). Because of the high frequency of ADRs in orthopaedic (25%), general medicine (22%), and oncology (16%) patients, improved control of the drugs used in these specialties is required. Additionally, the nurse team (52.7%) registered the most ADRs in medical records, most likely due to the job responsibilities of nurses. As expected, the most noticeable ADRs occurred in skin tissues, with such ADRs are more obvious to medical staff, with rashes being the most common reactions. Metamizole, tramadol, and vancomycin were responsible for 21, 11.6, and 8.4% of ADRs, respectively. The majority of ADRs had

  14. America's Tolerance for French Radicalism

    ERIC Educational Resources Information Center

    Wolin, Richard

    2008-01-01

    The publication of Francois Cusset's "French Theory" raises a series of fascinating questions concerning the trans-Atlantic transmission and circulation of ideas. Most important, it impels everyone to inquire why for a time French thought managed to flourish in American universities while French intellectuals rapidly abandoned the entire…

  15. Teaching the French Revolution.

    ERIC Educational Resources Information Center

    Adams, Thomas M.

    1989-01-01

    Reports on presentations made at a symposium sponsored by the Connecticut Humanities Council. Papers dealt with teaching the French Revolution by presenting European history in new relationships with the rest of the world and by examining the Declaration of the Rights of Man as it related to the role of women. (KO)

  16. The French Revolution.

    ERIC Educational Resources Information Center

    Scrofani, E. Robert; Johnston, Anne

    This 10-day unit on the French Revolution is designed to help high school students understand the interplay of economic, social, and political forces in the process of revolutionary change, and the development of modern democratic forms of government. Critical thinking and geographic skill activities are employed throughout the unit and include…

  17. I Can Speak French.

    ERIC Educational Resources Information Center

    New York City Board of Education, Brooklyn, NY. Div. of Curriculum and Instruction.

    The guide presents content and techniques for teaching conversational French in the elementary grades. It contains an introductory section and 20 units for classroom instruction. The introduction includes notes on the overall objectives of the course, general guidelines on classroom procedure, and specific techniques for use of the materials…

  18. Know Your Laws. French.

    ERIC Educational Resources Information Center

    Watson, Joan Q.; Ledun, Andree

    This French language version of "Know Your Laws" consists of 24 self-contained modules designed to acquaint the Florida adult student with laws she/he will meet in everyday life; fundamentals of local, state, and federal governments; and the criminal and juvenile justice systems. (The 130 objectives are categorized in the first three…

  19. French Theory's American Adventures

    ERIC Educational Resources Information Center

    Cusset, Francois

    2008-01-01

    In this article, the author discusses how it is simply too late to be still speaking about French theory and its role in the intellectual life of the United States today. It seems to many observers that the gap between real-life politics and theory's guerrillas is much too wide already, after 30 years of academic fever, for the two worlds to even…

  20. French 3200, Course Description.

    ERIC Educational Resources Information Center

    Newfoundland and Labrador Dept. of Education, St. John's. Div. of Instruction.

    The objectives and course content for French 3200, a secondary level course intended for the second or third year of four- and six-credit language course sequences in Newfoundland high schools, are outlined. Its primary objectives relate to the skill development in the four language skill areas (listening, speaking, reading, and writing),…

  1. Technoscientific French for Teachers.

    ERIC Educational Resources Information Center

    Muller, Brigitte D.

    A two-semester sequence of courses in French and Spanish for science and technology at Eastern Michigan University responds to alumni demands for better linguistic and cultural preparation for increasingly global business and industry. In addition, high schools teacher enrolled in the courses find they answer a need for professional upgrading of…

  2. Old French for Undergraduates.

    ERIC Educational Resources Information Center

    Sargent, Barbara Nelson

    A list of six main benefits of the study of Old French at the undergraduate level follows a discussion of the value, function, and goals of such a program. The advantages discussed result in: (1) a first-hand acquaintance with medieval masterpieces, (2) a sense of continuity in the history of literature, (3) improved techniques in critical…

  3. Living in Ontario French

    ERIC Educational Resources Information Center

    Nadasdi, Terry

    2005-01-01

    This article presents a variationist analysis of verbs meaning "reside" in Ontario French. Four lexical variants are examined: "demeurer," "habiter," "rester" and "vivre." Results reveal that "rester" is used most often by unrestricted speakers and least often by those whose use of French…

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

    PubMed Central

    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. PMID:25523367

  5. Post Launch Monitoring of food products: what can be learned from pharmacovigilance.

    PubMed

    van Puijenbroek, E P; Hepburn, P A; Herd, T M; van Grootheest, A C

    2007-03-01

    Post Launch Monitoring (PLM) is one of the new approaches that are used in assessing the safety of novel foods or ingredients. It shares a close resemblance with procedures applied in the field of medicines, where Post Marketing Surveillance (PMS) has been carried out since the beginning of the 1960s. For this reason, Unilever and the Netherlands Pharmacovigilance Centre Lareb, maintaining the national reporting scheme in the Netherlands for adverse drug reactions, have been working together to optimize the Unilever's Post Launch Monitoring service. As a result of this cooperation a practical model for conducting PLM for food products has been developed. This model is also applicable for consumer products in general. The system allows for coding and assessing reports and the early detection of 'signals' of unintended health reactions. The methodological issues surrounding reporting of possible health reactions and practical issues surrounding coding and assessment of the reports that were encountered in the first period of this partnership are discussed. In addition, similarities and differences concerning PMS and PLM are described.

  6. Pharmaco-EcoMicrobiology: a newer component of medical sciences bridging pharmacovigilance, ecology, and environmental microbiology.

    PubMed

    Shahid, M; Khardori, Nancy; Tripathi, T; Bergman, Scott

    2010-01-01

    Environmental scientists are now raising great concern on the impact of drugs on the environment and microbiologists are concerned about increasing antibiotic resistance due to irrational usage. However, a focus on the impact by the use of antibiotics (irrational/prescribed) to the environment at therapeutic doses has not been instituted. Even the World Health Organization (WHO) defined "Pharmacovigilance" activities as the monitoring, detection, assessment, understanding and prevention of any adverse reactions to drugs at therapeutic concentration on animals and humans. Nevertheless, there is little attention being given to identifying the adverse effects (ADEs) of antimicrobial agents on the environment (given at therapeutic doses). This issue has been highlighted in the present commentary and a new domain, "Pharmaco-EcoMicrobiology", has been proposed which should deal with and monitor such adverse effects. The term "Pharmaco-EcoMicrobiology" has been proposed to define the interplay between antimicrobial pharmacological agents and animate microbial ecology. This new domain, "Pharmaco-EcoMicrobiology", has been derived by the aggregation of three important branches of science (pharmacology+ecology+microbiology) and would be responsible for studying the ADEs due to antimicrobial drugs excreted in environment.

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

    PubMed Central

    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

  8. Pharmacovigilance and pharmacoepidemiology of drugs in a Mexican pediatric hospital. A proposed guide.

    PubMed

    Juárez-Olguín, Hugo; Pérez-Guillé, Gabriela; Flores-Pérez, Janett

    2007-02-01

    We describe the procedures of pharmacovigilance (PV) and pharmacoepidemiology (PE) of drugs in a pediatric hospital. These activities contribute to the detection and registration of adverse drug reactions and to determine the patterns of drug prescription among children attended at the hospital. The PV activities show that there is a relation between an increase in incidence of adverse drug reactions and the prescription of a larger number of drugs. The PE activities reveal that antibiotics are the most frequently prescribed drugs and next are drugs used for gastrointestinal diseases. Since PV and PE activities were initiated at our hospital, they have contributed to a more adequate use of drugs in children. As a conclusion of these activities, it could be that if the PE of a hospital is known, drug consumption can be optimally planned. PV and PE demonstrate that, if polytherapy is not necessary, it must be avoided. Finally, the present guide can be adopted to initiate PV and PE at a hospital.

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

    PubMed

    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.

  10. Biofuel Database

    National Institute of Standards and Technology Data Gateway

    Biofuel Database (Web, free access)   This database brings together structural, biological, and thermodynamic data for enzymes that are either in current use or are being considered for use in the production of biofuels.

  11. Database Administrator

    ERIC Educational Resources Information Center

    Moore, Pam

    2010-01-01

    The Internet and electronic commerce (e-commerce) generate lots of data. Data must be stored, organized, and managed. Database administrators, or DBAs, work with database software to find ways to do this. They identify user needs, set up computer databases, and test systems. They ensure that systems perform as they should and add people to the…

  12. Resveratrol: French Paradox Revisited

    PubMed Central

    Catalgol, Betul; Batirel, Saime; Taga, Yavuz; Ozer, Nesrin Kartal

    2012-01-01

    Resveratrol is a polyphenol that plays a potentially important role in many disorders and has been studied in different diseases. The research on this chemical started through the “French paradox,” which describes improved cardiovascular outcomes despite a high-fat diet in French people. Since then, resveratrol has been broadly studied and shown to have antioxidant, anti-inflammatory, anti-proliferative, and anti-angiogenic effects, with those on oxidative stress possibly being most important and underlying some of the others, but many signaling pathways are among the molecular targets of resveratrol. In concert they may be beneficial in many disorders, particularly in diseases where oxidative stress plays an important role. The main focus of this review will be the pathways affected by resveratrol. Based on these mechanistic considerations, the involvement of resveratrol especially in cardiovascular diseases, cancer, neurodegenerative diseases, and possibly in longevity will be is addressed. PMID:22822401

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

    PubMed Central

    Varallo, Fabiana Rossi; Planeta, Cleopatra S; de Carvalho Mastroianni, Patricia

    2017-01-01

    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 hospitals. PMID

  14. Improving Detection of Arrhythmia Drug-Drug Interactions in Pharmacovigilance Data through the Implementation of Similarity-Based Modeling

    PubMed Central

    Vilar, Santiago; Lorberbaum, Tal; Hripcsak, George; Tatonetti, Nicholas P.

    2015-01-01

    Identification of Drug-Drug Interactions (DDIs) is a significant challenge during drug development and clinical practice. DDIs are responsible for many adverse drug effects (ADEs), decreasing patient quality of life and causing higher care expenses. DDIs are not systematically evaluated in pre-clinical or clinical trials and so the FDA U. S. Food and Drug Administration relies on post-marketing surveillance to monitor patient safety. However, existing pharmacovigilance algorithms show poor performance for detecting DDIs exhibiting prohibitively high false positive rates. Alternatively, methods based on chemical structure and pharmacological similarity have shown promise in adverse drug event detection. We hypothesize that the use of chemical biology data in a post hoc analysis of pharmacovigilance results will significantly improve the detection of dangerous interactions. Our model integrates a reference standard of DDIs known to cause arrhythmias with drug similarity data. To compare similarity between drugs we used chemical structure (both 2D and 3D molecular structure), adverse drug side effects, chemogenomic targets, drug indication classes, and known drug-drug interactions. We evaluated the method on external reference standards. Our results showed an enhancement of sensitivity, specificity and precision in different top positions with the use of similarity measures to rank the candidates extracted from pharmacovigilance data. For the top 100 DDI candidates, similarity-based modeling yielded close to twofold precision enhancement compared to the proportional reporting ratio (PRR). Moreover, the method helps in the DDI decision making through the identification of the DDI in the reference standard that generated the candidate. PMID:26068584

  15. The Role of Systematic Reviews in Pharmacovigilance Planning and Clinical Trials Authorisation Application: Example from the SLEEPS Trial

    PubMed Central

    Gamble, Carrol; Wolf, Andrew; Sinha, Ian; Spowart, Catherine; Williamson, Paula

    2013-01-01

    Background Adequate sedation is crucial to the management of children requiring assisted ventilation on Paediatric Intensive Care Units (PICU). The evidence-base of randomised controlled trials (RCTs) in this area is small and a trial was planned to compare midazolam and clonidine, two sedatives widely used within PICUs neither of which being licensed for that use. The application to obtain a Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) required a dossier summarising the safety profiles of each drug and the pharmacovigilance plan for the trial needed to be determined by this information. A systematic review was undertaken to identify reports relating to the safety of each drug. Methodology/Principal Findings The Summary of Product Characteristics (SmPC) were obtained for each sedative. The MHRA were requested to provide reports relating to the use of each drug as a sedative in children under the age of 16. Medline was searched to identify RCTs, controlled clinical trials, observational studies, case reports and series. 288 abstracts were identified for midazolam and 16 for clonidine with full texts obtained for 80 and 6 articles respectively. Thirty-three studies provided data for midazolam and two for clonidine. The majority of data has come from observational studies and case reports. The MHRA provided details of 10 and 3 reports of suspected adverse drug reactions. Conclusions/Significance No adverse reactions were identified in addition to those specified within the SmPC for the licensed use of the drugs. Based on this information and the wide spread use of both sedatives in routine practice the pharmacovigilance plan was restricted to adverse reactions. The Clinical Trials Authorisation was granted based on the data presented in the SmPC and the pharmacovigilance plan within the clinical trial protocol restricting collection and reporting to adverse reactions. PMID:23554852

  16. Reporting of adverse events for marketed drugs: Need for strengthening safety database

    PubMed Central

    Apte, Aditi Anand

    2016-01-01

    Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders. PMID:27453826

  17. Utility of social media and crowd-sourced data for pharmacovigilance: a scoping review protocol

    PubMed Central

    Tricco, Andrea C; Zarin, Wasifa; Lillie, Erin; Pham, Ba; Straus, Sharon E

    2017-01-01

    analytics platform for social media and crowd-sourced data for pharmacovigilance in Canada and internationally. Registration details Our protocol was registered prospectively with the Open Science Framework (https://osf.io/kv9hu/). PMID:28104709

  18. Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction

    PubMed Central

    Betancourt, Blas Y; Marrero-Miragaya, María A; Jiménez-López, Giset; Valenzuela-Silva, Carmen; García-Iglesias, Elizeth; Hernández-Bernal, Francisco; Debesa-García, Francisco; González-López, Tania; Alvarez-Falcón, Leovaldo; López-Saura, Pedro A

    2005-01-01

    Background Streptokinase (SK) is an effective fibrinolytic agent for the treatment of acute myocardial infarction (AMI). The objective of the present study was to assess the adverse drug reactions (ADRs) associated with intravenous recombinant SK in patients with AMI in routine clinical practice. Methods A national, prospective and spontaneous reporting-based pharmacovigilance program was conducted in Cuba. Patient demographics, suspected ADR description, elements to define causality, and outcomes were documented and analyzed. Results A total of 1496 suspected ADRs identified in 792 patients out of the 1660 (47.7 %) prescriptions reported in the program, were received from July 1995 to July 2002. Most of the patients (71.3%) were male, 67.2% were white and mean age was 61.6 ± 13.0 years. The mean time interval between the onset of symptoms and the start of the SK infusion was 4.9 ± 3.7 h. The most frequently reported ADRs were hypotension, arrhythmias, chills, tremors, vomiting, nauseas, allergy, bleeding and fever. ADR severity was 38% mild, 38% moderate, 10% severe, and 4% very severe. Only 3 patients with hemorrhagic stroke were reported. Seventy-two patients died in-hospital mainly because of cardiac causes associated with the patient's underlying clinical condition. Mortality was 3 times more likely in patients suffering arrhythmias than in those without this event (odds ratio 3.1, 95% CI: 1.8 to 5.1). Most of the reported ADRs were classified as possibly or probably associated with the study medication. Conclusion Recombinant SK was associated with a similar post-marketing safety profile to those suggested in previous clinical trials. PMID:16262910

  19. Adverse drug reaction profile of microtubule-damaging antineoplastic drugs: A focused pharmacovigilance study in India

    PubMed Central

    Manohar, Hasitha Diana; Adiga, Shalini; Thomas, Joseph; Sharma, Ajitha

    2016-01-01

    Objectives: The aim of the study was to analyze the adverse drug reaction (ADR) profile of microtubule-damaging antineoplastic drugs (taxanes and vinca alkaloids) and to look for unexpected ADRs among the local population. Focused study on these drugs, rampantly used in oncology department for a wide variety of tumors including early and advanced malignancies, would enable better treatment care by physicians. Materials and Methods: Data on ADRs were collected from the cancer patients belonging to both gender and of all ages, on taxanes- or vinca-based cancer chemotherapy and reported in the Indian Pharmacopoeia Commission form. Causality was assessed using the WHO criteria and Naranjo's Algorithm. Preventability and severity of ADRs were also assessed. Results: A total of 97 ADRs were reported among 488 patients on microtubule-damaging anticancer drugs admitted over a period of 1 year. The incidence rate was 19.87%. Gastrointestinal system (40.2%) was the most affected followed by bone marrow (33%) and skin (8.2%). The highest incidence of ADRs was reported among paclitaxel (54.6%), and vincristine (39.2%). Most of the reported ADRs were of milder nature and preventable. The WHO causality assessment scale indicated 71.1% possible reactions. Conclusions: This study showed that most ADRs are preventable with effective ADR monitoring. There is a great need to create awareness among healthcare professionals regarding the importance of the pharmacovigilance system. Judicious use of the preventive measures will lead to a reduction in the incidence of ADRs due to the drug armamentarium, thereby enabling additional economic benefit to the patient and society. PMID:27721535

  20. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies.

    PubMed

    Bahri, Priya

    2010-12-01

    As a contribution to the debate on how best to communicate information on the effective and safe use of medicines to patients, healthcare professionals and the general public, this article proposes to distinguish between communication and transparency purposes, and to test a strategic health communication approach. Any organization aiming to improve medicines use could adapt this approach to its remits and legal obligations. The approach includes agreeing measurable communication objectives through shared problem ownership of all concerned parties, evidence-based design and a cyclic process for planning, implementation and evaluation of communication as a public health intervention. The evidence base, which supplements risk assessment for product- and situation-specific communication on safety concerns, would be derived from research into drug utilization, medical decision making and risk perception, as well as from the participation of patients and healthcare professionals. It is crucial to address the practical questions and concerns of medicine users and to find out why unfavourable patterns of medicine use persist, in order to develop behaviour change models for overcoming these obstacles. For this purpose, appropriate models for facilitating the participation of medicine users in the risk management process will need to be explored. Such two-way communication would inform risk assessment as well as the analysis of risk minimization options, allow for agreement upon communication objectives and enable understandable, attractive communication materials to be designed. The communication programme should use mixed media and repetition of messages for long-term success. This would require cooperation within healthcare and medical information systems. An evaluation of the effectiveness of the communication should support the sustainability of the programme and provide lessons for the future. Given its mission, the pharmacovigilance community has the standing and

  1. A framework for assessing the economic value of pharmacovigilance in low- and middle-income countries.

    PubMed

    Babigumira, Joseph B; Stergachis, Andy; Choi, Hye Lyn; Dodoo, Alexander; Nwokike, Jude; Garrison, Louis P

    2014-03-01

    Pharmacovigilance (PV) programs are an essential component of national healthcare systems. Well-functioning PV programs can improve population health by identifying and reducing medicines-related problems (MRPs). Many low- and middle-income countries lack functional PV systems, but this deficiency has not been described in terms of the potential economic value of strengthening PV systems. The assessment of economic value for PV can support rational decision making at the country level. We propose a framework for assessing the economic value of PV. We divide national PV systems into four levels: (1) no PV, (2) basic PV, (3) semi-functional PV, and (4) functional PV. These categories represent increasing levels of investment in PV capacity at the national or health facility level for all available medicines, including vaccines. The proposed framework can be used to estimate the costs of PV (including the value of investments to increase PV capacity and the costs of managing MRPs) and outcomes associated with PV (including improvements in morbidity, mortality, and quality of life as a result of the reduction in MRPs). The quantitative approach proposed for assessing costs and benefits uses a decision-analytic modeling framework that would estimate the value of the consequences of MRPs adjusted for their probability of occurrence. This allows the quantification of value using monetary outcomes (cost-benefit analysis), natural units (cost-effectiveness analysis), or mortality adjusted for quality of life or disability (cost-utility analysis). Evidence generated using this framework could assist policy makers, program managers, and donors in evaluating investments that aim to increase the capacity and efficiency of national and facility-level PV programs in low- and middle-income countries.

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

    PubMed Central

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

    2015-01-01

    Introduction: 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. Aim: To monitor and analyze the pattern and frequency of ADR to Ayurvedic medicines in an Ayurvedic hospital setup. Materials and Methods: 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. Results: 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. Conclusion: 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. PMID:27011712

  3. French perspectives on psychiatric classification.

    PubMed

    Crocq, Marc-Antoine

    2015-03-01

    This article reviews the role of the French schools in the development of psychiatric nosology. Boissier de Sauvages published the first French treatise on medical nosology in 1763. Until the 1880s, French schools held a pre-eminent position in the development of psychiatric concepts. From the 1880s until World War I, German-speaking schools exerted the most influence, featuring the work of major figures such as Emil Kraepelin and Eugen Bleuler. French schools were probably hampered by excessive administrative and cultural centralization. Between the 1880s and the 1930s, French schools developed diagnostic categories that set them apart from international classifications. The main examples are Bouffée Délirante, and the complex set of chronic delusional psychoses (CDPs), including chronic hallucinatory psychosis. CDPs were distinguished from schizophrenia by the lack of cognitive deterioration during evolution. Modern French psychiatry is now coming into line with international classification, such as DSM-5 and the upcoming ICD-11.

  4. [French immigration policy].

    PubMed

    Weil, P

    1994-01-01

    From the late nineteenth century through 1974, France permitted immigration to furnish workers and to compensate for the low level of fertility. Intense immigration from North Africa, the economic crisis of the 1970s, and other factors led to policy changes in 1974. French immigration policy since 1974 has fluctuated between guaranteeing foreigners equal rights regardless of their religion, race, culture, or national origin, and attempting to differentiate among immigrants depending on their degree of assimilability to French culture. From 1974 to 1988, France had five different policies regarding whether to permit new immigration and what to do about illegal immigrants. In July 1984, the four major political parties unanimously supported a measure in Parliament that definitively guaranteed the stay in France of legal immigrants, whose assimilation thus assumed priority. Aid for return to the homeland was no longer to be widely offered, and immigration of unskilled workers was to be terminated except for those originating in European Community countries. Major changes of government in 1988 and 1993 affected only the modalities of applying these principles. The number of immigrants has fluctuated since 1974. Unskilled workers, the only category whose entrance was specifically controlled by the 1984 measures, have declined from 174,000 in 1970 to 25,000 in the early 1990s. The number of requests for political asylum declined from 60,000 in 1989 to 27,000 in 1993, and in 1991, 15,467 persons were granted refugee status. The number of immigrants of all types permitted to remain in France declined from 250,000 or 3000 per year in the early 1970s to around 110,000 at present. Although the decline is significant, it appears insufficient to the government in power since 1993. Although migratory flows are often explained as the product of imbalance in the labor market or in demographic growth, the French experience suggests that government policies, both in the sending and

  5. The French Revolution on Film: American and French Perspectives

    ERIC Educational Resources Information Center

    Harison, Casey

    2005-01-01

    It is not hard to locate negative or condescending images of the French Revolution in aspects of popular American culture, including film. Despite a handful of instances where nuanced or ambiguous "messages" may be identified, the number of American film interpretations of the French Revolution that might be judged historically…

  6. Invitation Refusals in Cameroon French and Hexagonal French

    ERIC Educational Resources Information Center

    Farenkia, Bernard Mulo

    2015-01-01

    Descriptions of regional pragmatic variation in French are lacking to date the focus has been on a limited range of speech acts, including apologies, requests, compliments and responses to compliments. The present paper, a systematic analysis of invitation refusals across regional varieties of French, is designed to add to the research on…

  7. Image Databases.

    ERIC Educational Resources Information Center

    Pettersson, Rune

    Different kinds of pictorial databases are described with respect to aims, user groups, search possibilities, storage, and distribution. Some specific examples are given for databases used for the following purposes: (1) labor markets for artists; (2) document management; (3) telling a story; (4) preservation (archives and museums); (5) research;…

  8. Maize databases

    Technology Transfer Automated Retrieval System (TEKTRAN)

    This chapter is a succinct overview of maize data held in the species-specific database MaizeGDB (the Maize Genomics and Genetics Database), and selected multi-species data repositories, such as Gramene/Ensembl Plants, Phytozome, UniProt and the National Center for Biotechnology Information (NCBI), ...

  9. French intensive truck garden

    SciTech Connect

    Edwards, T D

    1983-01-01

    The French Intensive approach to truck gardening has the potential to provide substantially higher yields and lower per acre costs than do conventional farming techniques. It was the intent of this grant to show that there is the potential to accomplish the gains that the French Intensive method has to offer. It is obvious that locally grown food can greatly reduce transportation energy costs but when there is the consideration of higher efficiencies there will also be energy cost reductions due to lower fertilizer and pesticide useage. As with any farming technique, there is a substantial time interval for complete soil recovery after there have been made substantial soil modifications. There were major crop improvements even though there was such a short time since the soil had been greatly disturbed. It was also the intent of this grant to accomplish two other major objectives: first, the garden was managed under organic techniques which meant that there were no chemical fertilizers or synthetic pesticides to be used. Second, the garden was constructed so that a handicapped person in a wheelchair could manage and have a higher degree of self sufficiency with the garden. As an overall result, I would say that the garden has taken the first step of success and each year should become better.

  10. The French Revolution and "Revisionism."

    ERIC Educational Resources Information Center

    Langlois, Claude

    1990-01-01

    Outlines revisionist interpretations of the French Revolution that challenged the dominant historiographical tradition during the 1950s and 1960s. Distinguishes four central characteristics of revisionist works. Identifies a key split in current French Revolution historiography between reflection on nineteenth-century…

  11. French for Journalists: Classroom Techniques.

    ERIC Educational Resources Information Center

    Rodina, Herta

    The use of authentic materials for an advanced French course for students of journalism and communication has the drawback that authentic French sources assume a regular, informed readership sharing the same culture and history. A solution found at Ohio University is to use a publication that bridges the two cultures, such as the "Journal…

  12. Pharmacovigilance as a tool for safety and monitoring: a review of general issues and the specific challenges with end-stage renal failure patients

    PubMed Central

    Jacob, Dalia; Marrón, Belén; Ehrlich, Jay; Rutherford, Peter A

    2013-01-01

    Pharmacovigilance is instrumental in helping to ensure patient safety for both newly released drugs and those that are well established in the market. However, while pharmacovigilance procedures are strictly regulated in the clinical trial setting, post-marketing adverse event reporting is not well implemented or enforced. As such, the underreporting of adverse events, in relation to drugs that are on the market, is estimated to be in the region of 90%. The identification of drug safety issues in patients with complex diseases and extensive comorbidities is therefore particularly challenging. Dialysis patients – those with end-stage renal disease and often other comorbidities such as diabetes, hypertension, and cardiovascular disease – are a population with significant treatment challenges. Patients receive dialysis using complex medical devices (eg, a peritoneal dialysis home cycler) and also receive a range of pharmaceutical agents as part of dialysis itself (eg, peritoneal dialysis solutions). Many of the pharmaceutical agents used to treat these patients have been developed in populations without these complications and, therefore, an extensive knowledge of potential problems and contraindications in the dialysis population is lacking. It is important that the nephrology community understands the concept of pharmacovigilance – the pharmacologic science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly long-term and short-term side effects, of medicines. Health care professionals (HCPs) and providers, pharmaceutical companies, global regulatory agencies, and the patients themselves all play unique and critical roles in this process. This review defines the science of pharmacovigilance and the process of adverse event reporting, highlights the new directions that pharmacovigilance has taken, and provides insight for HCPs managing dialysis patients into the important role that they play in helping to shape

  13. Pharmacovigilance in India, Uganda and South Africa with reference to WHO’s minimum requirements

    PubMed Central

    Maigetter, Karen; Pollock, Allyson M.; Kadam, Abhay; Ward, Kim; Weiss, Mitchell G.

    2015-01-01

    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 bodies in

  14. Genome databases

    SciTech Connect

    Courteau, J.

    1991-10-11

    Since the Genome Project began several years ago, a plethora of databases have been developed or are in the works. They range from the massive Genome Data Base at Johns Hopkins University, the central repository of all gene mapping information, to small databases focusing on single chromosomes or organisms. Some are publicly available, others are essentially private electronic lab notebooks. Still others limit access to a consortium of researchers working on, say, a single human chromosome. An increasing number incorporate sophisticated search and analytical software, while others operate as little more than data lists. In consultation with numerous experts in the field, a list has been compiled of some key genome-related databases. The list was not limited to map and sequence databases but also included the tools investigators use to interpret and elucidate genetic data, such as protein sequence and protein structure databases. Because a major goal of the Genome Project is to map and sequence the genomes of several experimental animals, including E. coli, yeast, fruit fly, nematode, and mouse, the available databases for those organisms are listed as well. The author also includes several databases that are still under development - including some ambitious efforts that go beyond data compilation to create what are being called electronic research communities, enabling many users, rather than just one or a few curators, to add or edit the data and tag it as raw or confirmed.

  15. Status of French reactors

    SciTech Connect

    Ballagny, A.

    1997-08-01

    The status of French reactors is reviewed. The ORPHEE and RHF reactors can not be operated with a LEU fuel which would be limited to 4.8 g U/cm{sup 3}. The OSIRIS reactor has already been converted to LEU. It will use U{sub 3}Si{sub 2} as soon as its present stock of UO{sub 2} fuel is used up, at the end of 1994. The decision to close down the SILOE reactor in the near future is not propitious for the start of a conversion process. The REX 2000 reactor, which is expected to be commissioned in 2005, will use LEU (except if the fast neutrons core option is selected). Concerning the end of the HEU fuel cycle, the best option is reprocessing followed by conversion of the reprocessed uranium to LEU.

  16. Nurses in municipal care of the elderly act as pharmacovigilant intermediaries: a qualitative study of medication management

    PubMed Central

    Johansson-Pajala, Rose-Marie; Jorsäter Blomgren, Kerstin; Bastholm-Rahmner, Pia; Fastbom, Johan; Martin, Lene

    2016-01-01

    Objective To explore registered nurses’ experience of medication management in municipal care of the elderly in Sweden, with a focus on their pharmacovigilant activities. Design A qualitative approach using focus-group discussions was chosen in order to provide in-depth information. Data were analysed by qualitative content analysis. Setting Five focus groups in five different long-term care settings in two regions in Sweden. Subject A total of 21 registered nurses (RNs), four men and 17 women, aged 27–65 years, with 4–34 years of nursing experience. Results The findings reveal that RNs in municipal long-term care settings can be regarded as “vigilant intermediaries” in the patients’ drug treatments. They continuously control the work of staff and physicians and mediate between them, and also compensate for existing shortcomings, both organizational and in the work of health care professionals. RNs depend on other health care professionals to be able to monitor drug treatments and ensure medication safety. They assume expanded responsibilities, sometimes exceeding their formal competence, and try to cover for deficiencies in competence, experience, accessibility, and responsibility-taking. Conclusion The RNs play a central but also complex role as “vigilant intermediaries” in the medication monitoring process, including the issue of responsibility. Improving RNs’ possibility to monitor their patients’ drug treatments would enable them to prevent adverse drug events in their daily practice. New strategies are justified to facilitate RNs’ pharmacovigilant activities. Key pointsThis study contributes to the understanding of registered nurses’ (RNs’) role in medication management in municipal care of the elderly (i.e. detecting, assessing, and preventing adverse drug events or any drug-related problems). RNs can be considered to be “vigilant intermediaries” in elderly patients’ drug treatments, working at a distance from staff

  17. Mining approximate temporal functional dependencies with pure temporal grouping in clinical databases.

    PubMed

    Combi, Carlo; Mantovani, Matteo; Sabaini, Alberto; Sala, Pietro; Amaddeo, Francesco; Moretti, Ugo; Pozzi, Giuseppe

    2015-07-01

    Functional dependencies (FDs) typically represent associations over facts stored by a database, such as "patients with the same symptom get the same therapy." In more recent years, some extensions have been introduced to represent both temporal constraints (temporal functional dependencies - TFDs), as "for any given month, patients with the same symptom must have the same therapy, but their therapy may change from one month to the next one," and approximate properties (approximate functional dependencies - AFDs), as "patients with the same symptomgenerallyhave the same therapy." An AFD holds most of the facts stored by the database, enabling some data to deviate from the defined property: the percentage of data which violate the given property is user-defined. According to this scenario, in this paper we introduce approximate temporal functional dependencies (ATFDs) and use them to mine clinical data. Specifically, we considered the need for deriving new knowledge from psychiatric and pharmacovigilance data. ATFDs may be defined and measured either on temporal granules (e.g.grouping data by day, week, month, year) or on sliding windows (e.g.a fixed-length time interval which moves over the time axis): in this regard, we propose and discuss some specific and efficient data mining techniques for ATFDs. We also developed two running prototypes and showed the feasibility of our proposal by mining two real-world clinical data sets. The clinical interest of the dependencies derived considering the psychiatry and pharmacovigilance domains confirms the soundness and the usefulness of the proposed techniques.

  18. Questions about complementary and alternative medicine to the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS): a descriptive pilot study

    PubMed Central

    2014-01-01

    Background Provision of clinically relevant information about complementary and alternative medicine (CAM) to health care professionals is not well described. The aim of the study was to assess questions about CAM to the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS). Methods All question-answers pairs (QAPs) in the RELIS database indexed with alternative medicine from 2005-2010 constituted the study material. A randomly selected sample of 100 QAPs was characterized with regard to type of question (category, patient-specific or general), occupation and workplace of enquirer, the type of information search performed (simple or advanced), and if the answers contained information to provide factual or consultative replies (facts about or advice on clinical use of CAM, respectively). Proportions were compared with Fisher’s exact test with significance at the 0.05 level. Results One thousand and thirty-eight (7.7%) out of 13 482 questions involved CAM. Eighty-two out of 100 questions concerned products containing one or more herbs, vitamins and minerals as well as other substances. Thirty-eight out of 100 questions concerned the category documentation (substance identification and/or literature reports about clinical effects), 36 interactions, 16 adverse effects, 9 pregnancy and lactation, and 1 question concerned contraindications. Sixty-three questions were patient-specific and 37 general. Fifty-four questions came from physicians, 33 from pharmacists and 13 from others (including nurses, midwives, students, CAM practitioners, and the public). Pharmacists asked more frequently about interactions while physicians asked more frequently about adverse effects (p < 0.05). Seventy-six of the questions came from outside hospital, mainly general practice and community pharmacies. Fifty-nine answers were based on a simple and 41 on an advanced information search. Thirty-three factual and 38 consultative answers were provided. In 29 answers

  19. ["Eosinophilia-myalgia" syndrome due to L-tryptophan containing products. Cooperative evaluation of French Regional Centers of Pharmacovigilance. Analysis of 24 cases].

    PubMed

    Castot, A; Bidault, I; Bournerias, I; Carlier, P; Efthymiou, M L

    1991-01-01

    By November 17, 1989, the MMWR published the 154 first reports of a syndrome consisting of myalgia and eosinophilia (EMS), occurring with the consumption of L-tryptophan containing products (L-TrpCp) and which might represent a new clinical entity. To standardize reporting over the country, the CDC of Atlanta developed the following case definition: 1) a peripheral blood total eosinophil count of more than 1 x 10(9) cells per liter 2) generalized myalgia sufficiently severe to affect a patient's ability to pursue daily activities 3) the exclusion of infections or neoplastic conditions. The FDA then, announced its intention to seek a nationwide recall of all tryptophan containing products, followed by other european countries (UK, Germany, France). In France, a first decree (January 4th 1990) completed by a decree on May 11th confirms this decision for one year. This measure did not concern the medicinal products or some dietary supplements for newborn or young children. Since December 11th, 1989, 24 cases have been reported to the Regional Adverse Drug Reaction Monitoring Centres in France. These cases share the same features as the cases notified previously in the USA: overrepresentation of females, no relationship with the time and the daily intake, clinical similarities to the Shulman syndrome, and unknown prognosis. Now, more than one year after the onset of this illness, it seems that discontinuation of the ingestion of L-TrpCp can resolve or improve the symptoms in most cases, but sometimes the syndrome can persist. The causal relationship between the ingestion of L-TrpCp and this syndrome has been established. Whatever the mechanism for the development of EMS among tryptophan users remains unclear, as well as the role of eosinophilia and the factors for fibroblast proliferation. The epidemic emergence of this syndrome in July 89 raises the possibility of the contamination of tryptophan during the manufacturing process. To confirm this hypothesis, the same unusual peak in HPLC analysis was found both in case-associated L-Trp lots and in implicated-japanese manufacturer L-Trp lots in USA. But this would not explain the previous EMS reports before this contamination. Other hypotheses consist an inabnormality of tryptophan metabolism and/or an autoimmune process.

  20. Teaching for Content: Greek Mythology in French.

    ERIC Educational Resources Information Center

    Giauque, Gerald S.

    An intermediate-level university French course in Greek mythology was developed to (1) improve student skills in reading, writing, speaking, and comprehending French, (2) familiarize students with Greek mythology, and (3) prepare students to deal better with allusions to Greek mythology in French literature. The texts used are a French translation…

  1. 21 CFR 169.115 - French dressing.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false French dressing. 169.115 Section 169.115 Food and... § 169.115 French dressing. (a) Description. French dressing is the separable liquid food or the... fabricated shall be safe and suitable. French dressing contains not less than 35 percent by weight...

  2. 7 CFR 993.7 - French prunes.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false French prunes. 993.7 Section 993.7 Agriculture... Order Regulating Handling Definitions § 993.7 French prunes. French prunes means: (a) Prunes produced from plums of the following varieties of plums: French (Prune d'Agen, Petite Prune d'Agen), Coates...

  3. Dialect Effects in Speech Perception: The Role of Vowel Duration in Parisian French and Swiss French

    ERIC Educational Resources Information Center

    Miller, Joanne L.; Mondini, Michele; Grosjean, Francois; Dommergues, Jean-Yves

    2011-01-01

    The current experiments examined how native Parisian French and native Swiss French listeners use vowel duration in perceiving the /[openo]/-/o/ contrast. In both Parisian and Swiss French /o/ is longer than /[openo]/, but the difference is relatively large in Swiss French and quite small in Parisian French. In Experiment 1 we found a parallel…

  4. Experiment Databases

    NASA Astrophysics Data System (ADS)

    Vanschoren, Joaquin; Blockeel, Hendrik

    Next to running machine learning algorithms based on inductive queries, much can be learned by immediately querying the combined results of many prior studies. Indeed, all around the globe, thousands of machine learning experiments are being executed on a daily basis, generating a constant stream of empirical information on machine learning techniques. While the information contained in these experiments might have many uses beyond their original intent, results are typically described very concisely in papers and discarded afterwards. If we properly store and organize these results in central databases, they can be immediately reused for further analysis, thus boosting future research. In this chapter, we propose the use of experiment databases: databases designed to collect all the necessary details of these experiments, and to intelligently organize them in online repositories to enable fast and thorough analysis of a myriad of collected results. They constitute an additional, queriable source of empirical meta-data based on principled descriptions of algorithm executions, without reimplementing the algorithms in an inductive database. As such, they engender a very dynamic, collaborative approach to experimentation, in which experiments can be freely shared, linked together, and immediately reused by researchers all over the world. They can be set up for personal use, to share results within a lab or to create open, community-wide repositories. Here, we provide a high-level overview of their design, and use an existing experiment database to answer various interesting research questions about machine learning algorithms and to verify a number of recent studies.

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

    PubMed Central

    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.

    2016-01-01

    Background: 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. Methods: 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. Results: 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%, P<.001). Conclusions: These data indicate that the overall pharmacologic prescription for treating a first episode of psychosis in Spain follows the clinical practice guideline recommendations, and, together with security 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. PMID:26506856

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

    PubMed

    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.

  7. Feudalism and the French Revolution.

    ERIC Educational Resources Information Center

    Kaiser, Thomas E.

    1979-01-01

    Reviews and questions the traditional established interpretation that the French Revolution was about feudalism. Concludes that revisionist historians have cast doubt upon the orthodox theory but that they have not supplied an alternative explanation. (Author/DB)

  8. Solubility Database

    National Institute of Standards and Technology Data Gateway

    SRD 106 IUPAC-NIST Solubility Database (Web, free access)   These solubilities are compiled from 18 volumes (Click here for List) of the International Union for Pure and Applied Chemistry(IUPAC)-NIST Solubility Data Series. The database includes liquid-liquid, solid-liquid, and gas-liquid systems. Typical solvents and solutes include water, seawater, heavy water, inorganic compounds, and a variety of organic compounds such as hydrocarbons, halogenated hydrocarbons, alcohols, acids, esters and nitrogen compounds. There are over 67,500 solubility measurements and over 1800 references.

  9. French perspectives on psychiatric classification

    PubMed Central

    Crocq, Marc-Antoine

    2015-01-01

    This article reviews the role of the French schools in the development of psychiatric nosology. Boissier de Sauvages published the first French treatise on medical nosology in 1763. Until the 1880s, French schools held a pre-eminent position in the development of psychiatric concepts. From the 1880s until World War I, German-speaking schools exerted the most influence, featuring the work of major figures such as Emil Kraepelin and Eugen Bleuler. French schools were probably hampered by excessive administrative and cultural centralization. Between the 1880s and the 1930s, French schools developed diagnostic categories that set them apart from international classifications. The main examples are Bouffée Délirante, and the complex set of chronic delusional psychoses (CDPs), including chronic hallucinatory psychosis. CDPs were distinguished from schizophrenia by the lack of cognitive deterioration during evolution. Modern French psychiatry is now coming into line with international classification, such as DSM-5 and the upcoming ICD-11. PMID:25987863

  10. French fireball network FRIPON

    NASA Astrophysics Data System (ADS)

    Colas, F.; Zanda, B.; Vaubaillon, J.; Bouley, S.; Marmo, C.; Audureau, Y.; Kwon, M. K.; Rault, J.-L.; Caminade, S.; Vernazza, P.; Gattacceca, J.; Birlan, M.; Maquet, L.; Egal, A.; Rotaru, M.; Birnbaum, C.; Cochard, F.; Thizy, O.

    2015-01-01

    FRIPON (Fireball Recovery and Interplanetary Observation Network) was recently founded by ANR (Agence Nationale de la Recherche), its aim being to connect meteoritical science with asteroidal and cometary sciences, in order to better understand our solar system formation and evolution. The main idea is to cover all the French territory to collect a large number of meteorites (one or two per year) with an accurate orbit determination, allowing to pinpoint possible parent bodies. 100 all-sky cameras will be installed at the end of 2015, creating a dense network with an average distance of 100 km between the stations. To maximize the accuracy of the orbit determination, we will mix our optical data with radar data from the GRAVES transmitter received by 25 stations (Rault et al., 2015). As the network installation and the creation of research teams for meteorites involves many persons, at least many more than our small team of professionals, we will develop a participative science network for amateurs called Vigie-Ciel (Zanda et al., 2015). It will be possible to simply use our data, participate in research campaigns or even add cameras to the FRIPON network.

  11. Affective norms for 720 French words rated by children and adolescents (FANchild).

    PubMed

    Monnier, Catherine; Syssau, Arielle

    2016-12-07

    FANchild (French Affective Norms for Children) provides norms of valence and arousal for a large corpus of French words (N = 720) rated by 908 French children and adolescents (ages 7, 9, 11, and 13). The ratings were made using the Self-Assessment Manikin (Lang, 1980). Because it combines evaluations of arousal and valence and includes ratings provided by 7-, 9-, 11-, and 13-year-olds, this database complements and extends existing French-language databases. Good response reliability was observed in each of the four age groups. Despite a significant level of consensus, we found age differences in both the valence and arousal ratings: Seven- and 9-year-old children gave higher mean valence and arousal ratings than did the other age groups. Moreover, the tendency to judge words positively (i.e., positive bias) decreased with age. This age- and sex-related database will enable French-speaking researchers to study how the emotional character of words influences their cognitive processing, and how this influence evolves with age. FANchild is available at https://www.researchgate.net/profile/Catherine_Monnier/contributions .

  12. The new IAGOS Database Portal

    NASA Astrophysics Data System (ADS)

    Boulanger, Damien; Gautron, Benoit; Thouret, Valérie; Fontaine, Alain

    2016-04-01

    IAGOS (In-service Aircraft for a Global Observing System) is a European Research Infrastructure which aims at the provision of long-term, regular and spatially resolved in situ observations of the atmospheric composition. IAGOS observation systems are deployed on a fleet of commercial aircraft. The IAGOS database is an essential part of the global atmospheric monitoring network. It contains IAGOS-core data and IAGOS-CARIBIC (Civil Aircraft for the Regular Investigation of the Atmosphere Based on an Instrument Container) data. The IAGOS Database Portal (http://www.iagos.fr, damien.boulanger@obs-mip.fr) is part of the French atmospheric chemistry data center AERIS (http://www.aeris-data.fr). The new IAGOS Database Portal has been released in December 2015. The main improvement is the interoperability implementation with international portals or other databases in order to improve IAGOS data discovery. In the frame of the IGAS project (IAGOS for the Copernicus Atmospheric Service), a data network has been setup. It is composed of three data centers: the IAGOS database in Toulouse; the HALO research aircraft database at DLR (https://halo-db.pa.op.dlr.de); and the CAMS data center in Jülich (http://join.iek.fz-juelich.de). The CAMS (Copernicus Atmospheric Monitoring Service) project is a prominent user of the IGAS data network. The new portal provides improved and new services such as the download in NetCDF or NASA Ames formats, plotting tools (maps, time series, vertical profiles, etc.) and user management. Added value products are available on the portal: back trajectories, origin of air masses, co-location with satellite data, etc. The link with the CAMS data center, through JOIN (Jülich OWS Interface), allows to combine model outputs with IAGOS data for inter-comparison. Finally IAGOS metadata has been standardized (ISO 19115) and now provides complete information about data traceability and quality.

  13. A Film Study Option for HSC French

    ERIC Educational Resources Information Center

    Connole, Pat

    1974-01-01

    In 1974, after a trial period of two years, the study of two selected French feature films will be offered as an option to the study of prescribed texts in Higher School Certificate French in Victoria. (Author)

  14. Atomic Databases

    NASA Astrophysics Data System (ADS)

    Mendoza, Claudio

    2000-10-01

    Atomic and molecular data are required in a variety of fields ranging from the traditional astronomy, atmospherics and fusion research to fast growing technologies such as lasers, lighting, low-temperature plasmas, plasma assisted etching and radiotherapy. In this context, there are some research groups, both theoretical and experimental, scattered round the world that attend to most of this data demand, but the implementation of atomic databases has grown independently out of sheer necessity. In some cases the latter has been associated with the data production process or with data centers involved in data collection and evaluation; but sometimes it has been the result of individual initiatives that have been quite successful. In any case, the development and maintenance of atomic databases call for a number of skills and an entrepreneurial spirit that are not usually associated with most physics researchers. In the present report we present some of the highlights in this area in the past five years and discuss what we think are some of the main issues that have to be addressed.

  15. The French Revolution: A Simulation Game

    ERIC Educational Resources Information Center

    Kiernan, James Patrick

    1978-01-01

    Describes a college-level simulation game about the French Revolution. Based on George Lefebvre's "The Coming of the French Revolution," the role-play focuses on social and economic causes of the revolution and allows students to understand citizens' grievances against the French government. (AV)

  16. France: Africans and the French Revolution.

    ERIC Educational Resources Information Center

    Fatunde, Tunde

    1989-01-01

    The French Revolution had profound and long-term effects for Africans, both in Africa and throughout the Western hemisphere. Revolutionary leaders not only opposed the emancipation of slaves in French territories but supported an intensified slave trade, sparking numerous rebellions. French exploitation of Africans extended well into the twentieth…

  17. English versus French: Language Rivalry in Tunisia.

    ERIC Educational Resources Information Center

    Battenburg, John

    1997-01-01

    Examines the competition between English and French in Tunisian educational institutions and programs. Scrutinizes two periods in postprotectorate Tunisia: the introduction of English and the spread of English. Findings indicate that the decline in French linguistic influence may be accompanied by a future decrease in French political and economic…

  18. A Comparative Evaluation of French Grammar Checkers.

    ERIC Educational Resources Information Center

    Burston, Jack

    1996-01-01

    Four grammar checkers, all of French Canadian origin, were evaluated: "Le Correcteur 101,""GramR,""Hugo Plus," and "French Proofing Tools." Results indicate that "Le Correcteur 101" is the best French grammar checker on the market and worth its premium cost. (two references) (CK)

  19. An Interview with Fiona French

    ERIC Educational Resources Information Center

    Lewis, David

    2005-01-01

    In this interview Fiona French discusses her work and career with David Lewis. She describes early influences and stresses her lifelong love of colour and pattern. Amongst other themes she considers the factual basis of most of her books and her lack of interest in fantasy; her preference for clear, simple prose; her constant shifts in style and…

  20. Normenbuch Franzoesisch (Norm Book French)

    ERIC Educational Resources Information Center

    Pamp, Friedhelm

    1976-01-01

    Critizes the Norm Book for French Final (Abitur) Examination 1975 for German Schools, as to its arrangement and some resulting difficulties; also for its over-emphasis on written work over speaking. Additional publications are needed to make the existing requirements more specific. (Text is in German.) (IFS/WGA)

  1. Guide to French Noun Gender.

    ERIC Educational Resources Information Center

    Wilson, Perkins

    This guide presents a system for determining the qender of French nouns that has been tested against 12,000 pages of general reading: novels, history, social science, law, finance, and the Bible. The guide discusses the rules for determining gender and also presents various lists of the non-routine or exceptions to the rules. It is asserted that…

  2. [Herman Lundborg and French eugenicists].

    PubMed

    Drouard, A

    1999-01-01

    Herman Lundborg, the director of the Institute of Racial Biology in Uppsala, corresponded with some prominent French eugenicists in the 1920s and 1930s. The historical context of this correspondence is analyzed, and the importance of the national differences as well as of the international eugenic organization's efforts are emphasized.

  3. French on the Advanced Level.

    ERIC Educational Resources Information Center

    Pawlik, Teresa Wilkinson

    1969-01-01

    Presented in this article is an outline of some of the special interest course work included in the curriculum guidelines being developed in the Atlanta Public Schools System for advanced secondary school French classes. Titles of the audiolingually-oriented courses described are--(1) "Teenagers and Teenage Life in France Today," (2)…

  4. Cinque's Functional Verbs in French

    ERIC Educational Resources Information Center

    Rowlett, Paul

    2007-01-01

    This article focuses on the syntax of a number of subcategories of verb in French which are compatible with a following bare infinitive and which express various kinds of grammatical tense, mood, modality, aspect and voice, as well as such (more lexical?) notions as perception, causation and locomotion. The article starts by cataloguing a number…

  5. Some "English" Words in French.

    ERIC Educational Resources Information Center

    Thogmartin, Clyde

    1984-01-01

    Examines "pseudoborrowing" of some English words into the French vocabulary. Considered the prestige language of Western Europe, English is viewed as a social hallmark of higher education; thus, even a modest knowledge and use of English reinforces this attitude. However, also suggests a modification of this concept, noting a reciprocal prestige…

  6. French String Grammar. Final Report.

    ERIC Educational Resources Information Center

    New York Univ., NY. Linguistic String Project.

    This work reports on an initial study of the possibility of providing a suitable framework for the teaching of a foreign language grammar through string analysis, using French as the target language. Analysis of a string word list (word-class sequences) yields an overall view of the grammar. Details are furnished in a set of restrictions which…

  7. Verlan: Talking Backwards in French.

    ERIC Educational Resources Information Center

    Lefkowitz, Natalie J.

    1989-01-01

    The history of "Verlan," a form of French word play involving inversion of syllables with varying degrees of complexity, is described and its phonological and morphological patterns are outlined. Appropriate and inappropriate contexts for use of Verlan, extralinguistic functions, and the results of lexicalization of verlanized words are…

  8. A novel multipatient intranasal diamorphine spray for use in acute pain in children: pharmacovigilance data from an observational study

    PubMed Central

    Kendall, Jason; Maconochie, Ian; Wong, Ian C K; Howard, Richard

    2015-01-01

    Objectives To establish the safety of an intranasal diamorphine (IND) spray in children. Design An open-label, single-dose pharmacovigilance trial. Setting Emergency departments in eight UK hospitals. Participants Children aged 2–16 years with a fracture or other trauma. Outcome measures Adverse events (AE) specifically related to nasal irritation, respiratory and central nervous system depression. Results 226 patients received 0.1 mg/kg IND. No serious or severe AEs occurred. The incidence of treatment-emergent AEs (TEAEs) was 26.5% (95% CI 20.9% to 32.8%), 93% being mild. 89% were related to treatment, all being known effects of the drug or route of administration except for three events in two patients. 20.4% (95% CI 15.3% to 26.2%) patients reported nasal irritation, all mild except one moderate and one ‘unknown’ severity. No respiratory depression was reported. Three AEs related to reduced Glasgow Coma Score (GCS) occurred, all mild. Conclusions There were no safety concerns raised during the conduct of the study. In addition to expected side effects, IND can cause mild nasal irritation in a proportion of patients. European Union Drug Regulating Authorities Clinical Trial No 2009-014982-16. PMID:24406329

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

    PubMed Central

    Sarker, Abeed; O’Connor, Karen; Ginn, Rachel

    2015-01-01

    Objective 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. Methods 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. Results 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. Conclusion 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. PMID:25755127

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

    PubMed

    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.

  11. Hepatotoxicity associated with agomelatine and other antidepressants: Disproportionality analysis using pooled pharmacovigilance data from the Uppsala Monitoring Centre.

    PubMed

    Gahr, Maximilian; Zeiss, René; Lang, Dirk; Connemann, Bernhard J; Schönfeldt-Lecuona, Carlos

    2015-07-01

    Since its marketing approval, the attention to the hepatic side-effect profile of the antidepressant agomelatine (AGM) has gradually increased. Several cases of severe hepatotoxic adverse drug reactions (ADR) have been reported and the European Medicines Agency has released a safety warning regarding AGM-associated hepatotoxicity. However, there are insufficient data for an adequate safety assessment of AGM-related hepatotoxicity. Therefore, we performed a quantitative signal detection analysis using pharmacovigilance data from the Uppsala Monitoring Centre from the WHO that records ADR data from worldwide sources; we calculated reporting odds ratios (ROR) as measures for disproportionality within a case/non-case approach for AGM and several other antidepressants. AGM was statistically associated with an increased risk of hepatotoxicity (ROR 6.4 [95%CI 5.7-7.2]) as well as both positive controls: amineptine (ROR 38.4 [95%CI 33.8-43.6]) and nefazodone (ROR 3.2 [95%CI 3.0-3.5]). Following amineptine, AGM was associated with the second highest ROR, followed by tianeptine (ROR 4.4 [95%CI 3.6-5.3]), mianserin (ROR 3.6 [95%CI 3.3-3.9]), and nefazodone. These results support the hypothesis that AGM is associated with relevant hepatotoxicity. However, the used data and applied method do not allow a quantitative evaluation of hepatotoxicity or assessment of substance-specific differences regarding the extent of hepatotoxicity.

  12. Text mining for pharmacovigilance: Using machine learning for drug name recognition and drug-drug interaction extraction and classification.

    PubMed

    Ben Abacha, Asma; Chowdhury, Md Faisal Mahbub; Karanasiou, Aikaterini; Mrabet, Yassine; Lavelli, Alberto; Zweigenbaum, Pierre

    2015-12-01

    Pharmacovigilance (PV) is defined by the World Health Organization as the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. An essential aspect in PV is to acquire knowledge about Drug-Drug Interactions (DDIs). The shared tasks on DDI-Extraction organized in 2011 and 2013 have pointed out the importance of this issue and provided benchmarks for: Drug Name Recognition, DDI extraction and DDI classification. In this paper, we present our text mining systems for these tasks and evaluate their results on the DDI-Extraction benchmarks. Our systems rely on machine learning techniques using both feature-based and kernel-based methods. The obtained results for drug name recognition are encouraging. For DDI-Extraction, our hybrid system combining a feature-based method and a kernel-based method was ranked second in the DDI-Extraction-2011 challenge, and our two-step system for DDI detection and classification was ranked first in the DDI-Extraction-2013 task at SemEval. We discuss our methods and results and give pointers to future work.

  13. Stackfile Database

    NASA Technical Reports Server (NTRS)

    deVarvalho, Robert; Desai, Shailen D.; Haines, Bruce J.; Kruizinga, Gerhard L.; Gilmer, Christopher

    2013-01-01

    This software provides storage retrieval and analysis functionality for managing satellite altimetry data. It improves the efficiency and analysis capabilities of existing database software with improved flexibility and documentation. It offers flexibility in the type of data that can be stored. There is efficient retrieval either across the spatial domain or the time domain. Built-in analysis tools are provided for frequently performed altimetry tasks. This software package is used for storing and manipulating satellite measurement data. It was developed with a focus on handling the requirements of repeat-track altimetry missions such as Topex and Jason. It was, however, designed to work with a wide variety of satellite measurement data [e.g., Gravity Recovery And Climate Experiment -- GRACE). The software consists of several command-line tools for importing, retrieving, and analyzing satellite measurement data.

  14. French roots of French neo-lamarckisms, 1879-1985.

    PubMed

    Loison, Laurent

    2011-01-01

    This essay attempts to describe the neo-Lamarckian atmosphere that was dominant in French biology for more than a century. Firstly, we demonstrate that there were not one but at least two French neo-Lamarckian traditions. This implies, therefore, that it is possible to propose a clear definition of a (neo)Lamarckian conception, and by using it, to distinguish these two traditions. We will see that these two conceptions were not dominant at the same time. The first French neo-Lamarckism (1879-1931) was structured by a very mechanic view of natural processes. The main representatives of this first period were scientists such as Alfred Giard (1846-1908), Gaston Bonnier (1853-1922) and Félix Le Dantec (1869-1917). The second Lamarckism - much more vitalist in its inspiration - started to develop under the supervision of people such as Albert Vandel (1894-1980) and Pierre-Paul Grassé (1895-1985). Secondly, this essay suggests that the philosophical inclinations of these neo-Lamarckisms reactivated a very ancient and strong dichotomy of French thought. One part of this dichotomy is a material, physicalist tradition, which started with René Descartes but developed extensively during the 18th and 19th centuries. The other is a spiritual and vitalist reaction to the first one, which also had a very long history, though it is most closely associated with the work of Henri Bergson. Through Claude Bernard, the first neo-Lamarckians tried to construct a mechanical and determinist form of evolutionary theory which was, in effect, a Cartesian theory. The second wave of neo-Lamarckians wanted to reconsider the autonomy and reactivity of life forms, in contrast to purely physical systems.

  15. Venus transits - A French view

    NASA Astrophysics Data System (ADS)

    Débarbat, Suzanne

    2005-04-01

    After a careful study of Mars observations obtained by Tycho Brahé (1546-1601), Kepler (1571-1630) discovered the now-called Kepler's third law. In 1627 he published his famous Tabulae Rudolphinae, a homage to his protector Rudolph II (1552-1612), tables (Kepler 1609, 1627) from which he predicted Mercury and Venus transits over the Sun. In 1629 Kepler published his Admonitio ad Astronomos Advertisement to Astronomers (Kepler 1630), Avertissement aux Astronomes in French Au sujet de phénomènes rares et étonnants de l'an 1631: l'incursion de Vénus et de Mercure sur le Soleil. This was the beginning of the interest of French astronomers, among many others, in such transits, mostly for Venus, the subject of this paper in which dates are given in the Gregorian calendar.

  16. [Twenty-five years of the French Addictovigilance Network (FAN)].

    PubMed

    Micallef, Joëlle; Mallaret, Michel

    2016-09-01

    Based on recommendations from the World Health Organization (WHO), the French addictovigilance network was set up since 1990, in order to assess and to monitor the potential for abuse and dependence of psychoactive substances. This network composed of 13 addictovigilance centers implemented in medical pharmacology departments of French university hospitals has developed specific pharmacoepidemiological tools repeated each year so as to lead us to updated pharmacological indicators related to drug abuse. As a single source may not be informative enough, the French addictovigilance network consider simultaneously a range of indicators focusing on health insurance database, health professional sentinel networks, characteristics of psychotropic consumptions and analysed them from a medical and pharmacological point of view combined to pharmacodynamic and pharmacokinetic data. The task force and the original role of this addictovigilance network is to work with reactivity to all different levels (local, regional, national) linked to all heath professionals in order to detect more quickly a potential warning signal leading to information, public health decision at a regional and/or national level and contributing also to a European and an international overview.

  17. [The French lessons of anatomy].

    PubMed

    Bouchet, Alain

    2003-01-01

    The "Lessons of Anatomy" can be considered as a step of Medicine to Art. For several centuries the exhibition of a corpse's dissection was printed on the title-page of published works. Since the seventeenth century, the "Lessons of Anatomy" became a picture on the title-page in order to highlight the well-known names of the european anatomists. The study is limited to the French Lessons of Anatomy found in books or pictures after the invention of printing.

  18. Emotional norms for 524 French personality trait words.

    PubMed

    Ric, François; Alexopoulos, Theodore; Muller, Dominique; Aubé, Benoîte

    2013-06-01

    Newly measured rating norms provide a database of emotion-related dimensions for 524 French trait words. Measures include valence, approach/avoidance tendencies associated with the trait, possessor- and other-relevance of the trait, and discrete emotions conveyed by the trait (i.e., anger, disgust, fear, happiness, and sadness). The normative data were obtained from 328 participants and were revealed to be stable across samples and gender. These data go beyond a dimensional structure and consider more fine-grained descriptions such as the categorical emotions, as well as the perspective of the evaluator conveyed by the traits. They should thus be particularly useful for researchers interested in emotion or in the emotional dimension of cognition, action, or personality. The database is available as supplementary material.

  19. Evaluation of gemtuzumab ozogamycin associated sinusoidal obstructive syndrome: Findings from an academic pharmacovigilance program review and a pharmaceutical sponsored registry

    PubMed Central

    Magwood-Golston, Jametta S.; Kessler, Samuel; Bennett, Charles L.

    2016-01-01

    Background In 2000, the Food and Drug Administration (FDA) approved gemtuzumab ozogamycin for monotherapy for older patients with relapsed AML. A 0.9% rate of hepatic sinusoidal obstructive syndrome (SOS) was noted in licensing trials. In 2001, FDA received reports of 14 GO-associated SOS cases from MD Anderson Cancer Center. A State of South Carolina/National Cancer Institute funded pharmacovigilance program and a manufacturer sponsored registry independently evaluated this concern. Methods The manufacturer’s registry and the academic program focused on risk factors and incidence of GO-associated SOS in routine clinical practice and clinical trial settings, respectively. Comparisons were made of findings and dissemination efforts from the two studies. Results Retrospective analysis of clinical trials by the academic initiative identified 99 cases of SOS among 221 GO-treated stem cell patients and 649 patients who did not undergo HSCTs. SOS rates were 3% when GO was administered at doses ≤6 mg/m2 as monotherapy or with non-hepatotoxic agents; 28% when administered with 6-thioguanine, a hepatotoxic agent; 15% when administered as monotherapy at doses at a dose of 9 mg/m2, and between 15% and 40% if a stem cell transplant (SCT) was performed within 3 months of GO administration. Death from SOS occurred in 33% of the cases. The manufacturer’s registry prospectively evaluated 482 GO-treated patients who received a mean dose of 7.8 mg/m2. Overall, 41% received concomitant chemotherapy, 18% had undergone prior SCT, 9.1% developed SOS, and death from SOS occurred in 60% of the SOS cases. Findings from each initiative were disseminated at national conferences and in peer-reviewed manuscripts beginning in 2003. Conclusion Retrospective review of clinical trials, case series, and FDA reports and prospective registries can provide important information on safety signals initially identified in licensing trials. PMID:27030962

  20. French security policy: From independence to interdependence

    SciTech Connect

    Laird, R.F.

    1986-01-01

    The book features the first-time translation of some of the most significant recent papers by leading French analysts of security affairs. Beginning with a look at continuity and change in French policy since de Gaulle, this books presents the evolution of French security policy in the 1970s and 1980s. Dr. Laird pays special attention to the French nuclear modernization process and to the trend in the last two decades toward greater emphasis on security interdependence within the Western Alliance at the expense of the classic Gaullist stance of independence. He examines the major dimensions of French security policy, particularly French nuclear employment policy and doctrine, the Franco-German relationship, and France's role in Europe and in East-West relations.

  1. Appropriating Written French: Literacy Practices in a Parisian Elementary Classroom

    ERIC Educational Resources Information Center

    Rockwell, Elsie

    2012-01-01

    In this article, I examine French language instruction in an elementary classroom serving primarily children of Afro-French immigrants in Paris. I show that a prevalent French language ideology privileges written over oral expression and associates full mastery of written French with rational thought and full inclusion in the French polity. This…

  2. JICST Factual Database JICST DNA Database

    NASA Astrophysics Data System (ADS)

    Shirokizawa, Yoshiko; Abe, Atsushi

    Japan Information Center of Science and Technology (JICST) has started the on-line service of DNA database in October 1988. This database is composed of EMBL Nucleotide Sequence Library and Genetic Sequence Data Bank. The authors outline the database system, data items and search commands. Examples of retrieval session are presented.

  3. Essentials for starting a pediatric clinical study (4): Clinical pediatric safety planning based on preclinical toxicity studies and pediatric pharmacovigilance guidance.

    PubMed

    Sheth, Neha

    2009-01-01

    Juvenile toxicology studies in animals provide useful information to guide monitoring of potential adverse effects in children especially on growth and development. In order to continue to gain knowledge and build upon these preclinical studies, recent experience has suggested that additional approaches for monitoring of safety concerns in the pediatric population may be required. Recently, pediatric guidance has become available from the health authorities which provide pharmacovigilance concepts as they specifically relate to drugs being developed for pediatric indications. Clinical trials are typically not robust enough to detect rare or delayed safety effects as the pediatric trials are relatively short-term. Furthermore, such long term or rare effects may not be detected via standard voluntary postmarketing surveillance. Safety monitoring of children with Juvenile Inflammatory Arthritis (JIA) taking nonsteroid anti-inflammatory drug (NSAID)s will be used as an example to describe a post-marketing risk management and pharmacovigilance program that serves to better evaluate safety data from various sources. The intent of this program is to identify adverse events (AE), including events with longer latency, which may be associated with NSAID use in a pediatric population. In this presentation, the 4 major components of the program are to be addressed. Such a program may serve as a model to proactively generate and monitor safety data in order to identify AEs that may be associated with new therapeutics for a pediatric population.

  4. Evaluation of the French Immersion Weekends, French Centre, University of Calgary, 1979-80.

    ERIC Educational Resources Information Center

    Klinck, Patricia

    Four French immersion weekends for continuing education students at the University of Calgary were evaluated. Each weekend involved recreational activities for twenty students and four French-speaking monitors at one of two recreational retreats near Calgary. The purpose of the program was to promote fluency in French by encouraging its use in a…

  5. A Search Engine to Access PubMed Monolingual Subsets: Proof of Concept and Evaluation in French

    PubMed Central

    Schuers, Matthieu; Soualmia, Lina Fatima; Grosjean, Julien; Kerdelhué, Gaétan; Kergourlay, Ivan; Dahamna, Badisse; Darmoni, Stéfan Jacques

    2014-01-01

    Background PubMed contains numerous articles in languages other than English. However, existing solutions to access these articles in the language in which they were written remain unconvincing. Objective The aim of this study was to propose a practical search engine, called Multilingual PubMed, which will permit access to a PubMed subset in 1 language and to evaluate the precision and coverage for the French version (Multilingual PubMed-French). Methods To create this tool, translations of MeSH were enriched (eg, adding synonyms and translations in French) and integrated into a terminology portal. PubMed subsets in several European languages were also added to our database using a dedicated parser. The response time for the generic semantic search engine was evaluated for simple queries. BabelMeSH, Multilingual PubMed-French, and 3 different PubMed strategies were compared by searching for literature in French. Precision and coverage were measured for 20 randomly selected queries. The results were evaluated as relevant to title and abstract, the evaluator being blind to search strategy. Results More than 650,000 PubMed citations in French were integrated into the Multilingual PubMed-French information system. The response times were all below the threshold defined for usability (2 seconds). Two search strategies (Multilingual PubMed-French and 1 PubMed strategy) showed high precision (0.93 and 0.97, respectively), but coverage was 4 times higher for Multilingual PubMed-French. Conclusions It is now possible to freely access biomedical literature using a practical search tool in French. This tool will be of particular interest for health professionals and other end users who do not read or query sufficiently in English. The information system is theoretically well suited to expand the approach to other European languages, such as German, Spanish, Norwegian, and Portuguese. PMID:25448528

  6. Current developments in French ethnopsychoanalysis.

    PubMed

    Sturm, Gesine; Nadig, Maya; Moro, Marie Rose

    2011-07-01

    French ethnopsychoanalytic approaches to therapy with immigrants combine the psychoanalytical interest in subjectivity with a specific concern for cultural factors and with the role migration plays as a crucial life event. Recent approaches consider culture as profoundly hybrid and use the notions of ''métissage'' and ''décentrage'' as central concepts. This article presents extracts from a qualitative study of ethnopsychoanalytic therapies with immigrant families. The authors argue that the ethnopsychoanalytic approach helps to open new ways of considering cultural hybridity and create a third space where experiences ''from the margins'' may be verbalized.

  7. Aerodynamic characteristics of French consonants

    NASA Astrophysics Data System (ADS)

    Demolin, Didier; Hassid, Sergio; Soquet, Alain

    2004-05-01

    This paper reports some aerodynamic measurements made on French consonants with a group of ten speakers. Speakers were recorded while saying nonsense words in phrases such as papa, dis papa encore. The nonsense words in the study combined each of the French consonants with three vowels /i, a, u/ to from two syllables words with the first syllable being the same as the second. In addition to the audio signal, recordings were made of the oral airflow, the pressure of the air in the pharynx above the vocal folds and the pressure of the air in the trachea just below the vocal folds. The pharyngeal pressure was recorded via a catheter (i.d. 5 mm) passed through the nose so that its open end could be seen in the pharynx below the uvula. The subglottal pressure was recorded via a tracheal puncture between the first and the second rings of the trachea or between the cricoid cartilage and the first tracheal ring. Results compare subglottal presssure, pharyngeal pressure, and airflow values. Comparisons are made between values obtained with male and female subjects and various types of consonants (voiced versus voiceless at the same place of articulation, stops, fricatives, and nasals).

  8. Pharmacovigilance during the pre-approval phases: an evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines.

    PubMed

    Hartford, Craig G; Petchel, Kasia S; Mickail, Hani; Perez-Gutthann, Susana; McHale, Mary; Grana, John M; Marquez, Paula

    2006-01-01

    Pharmacovigilance science has traditionally been a discipline focussed on the postmarketing or post-authorisation period, with due attention directed towards pre-clinical safety data, clinical trials and adverse events. As the biological sciences have evolved, pharmacovigilance has slowly shifted toward earlier, proactive consideration of risks and potential benefits of drugs in the pre- and peri-approval stages of drug development, leading to a maturing of drug safety risk management. Further advances in biology, pharmacology and improvements in computational applications to medicine have led to the development of more complex medicines previously unobtainable and have also permitted a more thorough assessment of risks and potential benefits even earlier in the development process. Elevated public concern with the safety of more sophisticated medicines, combined with new science, have led pharmaceutical innovators, regulators and healthcare professionals to collaborate to develop guidelines, which drive enhanced pharmacovigilance and safety risk management earlier in drug development. In this paper, we review international guidelines on pharmacovigilance planning applicable to the pre-approval phases of medicines development and provide author opinion on these guidelines' potential drug safety implications. We discuss the possible evolution of a pharmaceutical industry model to respond to these guidelines; a view on multidisciplinary safety management teams is provided to encourage refinement of safety-signal identification and risk assessment early in drug development and to communicate important safety concerns to internal research efforts, patients, investigators and regulators. We further describe these functions in the context of the complexities of vulnerable populations, including the example of medicines research for paediatric populations. We also discuss the special role of epidemiology in pre-approval drug development and the impact on epidemiological

  9. A Mini-Film on French Kinesics.

    ERIC Educational Resources Information Center

    Walz, Joel

    This paper describes a silent film made by the author which illustrates various French gestures. The format is Super 8, and the film lasts five minutes. The script is given, along with an English translation. The story concerns several French students at an outdoor cafe wondering about one of their friends. The conversation includes 10 typical…

  10. French-African Cultures: A Resource Unit.

    ERIC Educational Resources Information Center

    Forbes, Barbara

    This resource unit concerns French-African cultures and their influence on other cultures. The materials may be incorporated into Levels 3, 4, and 5 French classes. Topics in the outline include environmental aspects; historical background; and cultural differences expressed in Senegal, Guinee, Mali, Cote d'Ivoire, Haute Volta, Togo, Dahomey,…

  11. Les affaires "en francais" (Business "In French").

    ERIC Educational Resources Information Center

    Sanko, Helene N.

    1993-01-01

    A French brochure entitled "700 Current Words for Business" was developed to familiarize the business community with modern French business vocabulary and avoid intrusion of terminology from other languages. Some terms are neologisms. Translations from Latin, Japanese, and English illustrate the etymology and morphological patterns of…

  12. French Romanticism and Napoleon's "Geometric Men."

    ERIC Educational Resources Information Center

    Cole, Robert A.

    1982-01-01

    French intellectual thought changed during the Napoleonic Era. The effects of the Enlightenment philosophers, the French Revolution, the Industrial Revolution, and Romanticism on the development of Napoleon's philosophical outlook are used to illustrate the changes occurring in France as a whole in the early nineteenth century. (AM)

  13. Metropolitan French: Familiarization & Short-Term Training.

    ERIC Educational Resources Information Center

    Iszkowski, Marie-Charlotte

    The U.S. Department of State's Foreign Service Institute French Familiarization and Short-Term (FAST) course for personnel working and living in France consists of 10 weeks of French language instruction combined with practical and cultural information. An introductory section outlines FAST course objectives and sample teaching techniques in…

  14. Syntactic Devices of Emphasis in Contemporary French.

    ERIC Educational Resources Information Center

    Hollerbach, Wolf

    A device of emphasis in French syntax is defined as a construction of syntactic paraphrase whose function is to make certain parts of a sentence stand out for purposes of contrast, clarification, differentiation, or because a given element is considered important. These devices exist in French because of the lack of a phonemic stress system, and…

  15. Vowel Aperture and Syllable Segmentation in French

    ERIC Educational Resources Information Center

    Goslin, Jeremy; Frauenfelder, Ulrich H.

    2008-01-01

    The theories of Pulgram (1970) suggest that if the vowel of a French syllable is open then it will induce syllable segmentation responses that result in the syllable being closed, and vice versa. After the empirical verification that our target French-speaking population was capable of distinguishing between mid-vowel aperture, we examined the…

  16. Le Francais Courant (Contemporary French), Part II.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    This course has been developed basically within the limits of Units 4-6 of "A-LM French: Level 1", second edition. The primary objectives are to develop French vocabulary relative to the family, home, transportation, and foods by continuing to work with short dialogues based on everyday, teenage experiences. While reviewing previously studied…

  17. Act Up-Paris: French Lessons

    ERIC Educational Resources Information Center

    Nakayama, Thomas K.

    2012-01-01

    The francophone world has always been at the center of the HIV/AIDS epidemic. From the mythical (French Canadian) "patient zero," Gaetan Dugas, to Rock Hudson's flight to Paris for medical treatment and the blaming of Haiti for AIDS, as well as the close relationships between Belgian and French and their former African colonies,…

  18. French Higher Education: A Cartoon Essay

    ERIC Educational Resources Information Center

    Hall, Matthew Henry

    2012-01-01

    In this cartoon essay, the author shares his experience from a travel to Paris to see the French higher education system. From his travel, he learned that in France, "degree" inflation may be an issue, but not grade inflation. On the flight home, the author reflects how French and American academics answer one question about the state of…

  19. The French Regions and Their Social Health

    ERIC Educational Resources Information Center

    Jany-Catrice, Florence

    2009-01-01

    In this article, a new indicator designed to capture the multidimensionality of the social health of the French regions is put to the test. Drawing on regional data for 2004, this indicator of social health (ISH) sheds new light on the social performance of the French regions. The worst performers are the highly urbanised regions, whereas others,…

  20. Lafayette School District: French Immersion Program

    ERIC Educational Resources Information Center

    Boudreaux, Nicole

    2007-01-01

    From 1969 to the late 1980's, most French programs in schools were based on a traditional foreign language instructional model, usually offering 30 minutes a day of French language instruction in elementary grades, increasing to 50 minutes a day in middle school. Contingent on funding and political swings over time, programs expanded from…

  1. Commercial French Radio in the Classroom.

    ERIC Educational Resources Information Center

    Melpignano, Richard J.

    1980-01-01

    Describes several techniques for implementing commercial radio to improve listening comprehension skills in the foreign language student. Canadian radio, accessible to much of the northern United States, brings news, weather, and sports, in French, to the student of French and provides major components for sharpening comprehension skills. (PJM)

  2. Reading Speed of Contracted French Braille

    ERIC Educational Resources Information Center

    Laroche, Louise; Boule, Jacinthe; Wittich, Walter

    2012-01-01

    This study was designed to address three hypotheses: (1) The reading speed of both readers of French braille and readers of French print will be faster in the silent condition; however, this gain in speed will be larger for print readers; (2) Individuals who acquired braille before age 10 will display faster reading speeds at lower error rates…

  3. Why Learn French for Business in 2001?

    ERIC Educational Resources Information Center

    Maratier-Declety, Guilhene

    This essay makes the case for why it is worth learning French for business purposes, even though it is acknowledged that English is increasingly the lingua franca of international business, science, technology, and the Internet. It is asserted that French is still the dominant language in some important markets, and being able to conduct business…

  4. Left Dislocation in Near-Native French

    ERIC Educational Resources Information Center

    Donaldson, Bryan

    2011-01-01

    The present study is concerned with the upper limits of SLA--specifically, mastery of the syntax-discourse interface in successful endstate learners of second-language (L2) French (near-native speakers). Left dislocation (LD) is a syntactic means of structuring spoken French discourse by marking topic. Its use requires speakers to coordinate…

  5. The French Language in the Americas.

    ERIC Educational Resources Information Center

    Valdman, Albert, Ed.

    The annual bulletin of the French 8 section of the Annual Meeting of the Modern Language Association of America is presented with the texts of papers read at both the 1969 and 1970 sessions. The 1970 papers, in French, include Jean Louis Darbelnet's "Etude Sociolinguistique des contacts entre 1'Anglais et le Francais au Canada et en…

  6. Business Letter Writing: English, French, and Japanese.

    ERIC Educational Resources Information Center

    Jenkins, Susan; Hinds, John

    1987-01-01

    Examination of business letters in English, French, and Japanese, focusing on prescriptive accounts in the respective languages, found that, despite amazingly similar surface characteristics, American business letters were reader-oriented, French business letters were writer-oriented, and Japanese business letters were oriented to the space…

  7. A Modern Curriculum in French Studies.

    ERIC Educational Resources Information Center

    Nelson, Robert J.

    The French department, commonly viewed by chairmen and faculty as the conveyor of culture, is admonished to revamp its curriculum and attempt to embrace a broader, more humane understanding of the nature of culture. With the traditional, belletristic, college French curriculum having been rejected in favor of programs based on "cogency, cohesion,…

  8. Radical Reform of the French University System

    ERIC Educational Resources Information Center

    Bereziat, Gilbert

    2008-01-01

    The French university system is in crisis. After its dismantlement during the French revolution, its rebirth was progressive under the third republic (1871-1945). But it was only after 1968 that the current universities developed, with an autonomy that is strictly supervised by the state. Since 1986 all experiments at modernizing the management of…

  9. Risk of gastrointestinal complications associated to NSAIDs, low-dose aspirin and their combinations: Results of a pharmacovigilance reporting system.

    PubMed

    Rafaniello, Concetta; Ferrajolo, Carmen; Sullo, Maria Giuseppa; Sessa, Maurizio; Sportiello, Liberata; Balzano, Antonio; Manguso, Francesco; Aiezza, Maria Luisa; Rossi, Francesco; Scarpignato, Carmelo; Capuano, Annalisa

    2016-02-01

    Gastrointestinal (GI) complications are one of the most limiting cause of use of NSAIDs. Beyond others well defined factors, history of peptic ulcer, older age, Helicobacter pylori infection and use of gastrotoxic drugs may affect their GI safety profile. In particular, the risk of GI complications associated to the use of antiplatelet drugs, especially low-dose acetylsalicylic acid (LDA) should deserve much attention. However, only few studies have focused on the effect of combination LDA/NSAIDs on the GI tract compared with the monotherapy and much less studies assessed this effect with multiple NSAIDs use. We aimed to characterize the GI safety profile of NSAIDs and LDA as monotherapy or their combinations in real-life conditions by analysing spontaneous adverse drug reactions (ADRs) reporting system in a Southern Italy. We used the case/non-case method in the Italian Pharmacovigilance Network (RNF). Cases were reports of GI events in the RNF between January 2007 and December 2011. Non-cases were all other reports during the same period. The association between NSAID and suspected GI ADRs was calculated using the reporting odds ratio (ROR) with 95% confidence intervals as a measure of disproportionality while adjusting for age, and concomitant use of antineoplastic agents or drugs for cardiovascular diseases. Sub-analysis were performed within the NSAID class. Among the 2816 adverse drug reactions recorded, we identified 374 (13.3%) cases of GI complications. Upper GI complications were the most frequently reported type of events. The highest associations were found for the combined use of NSAIDs and/or LDA, whilst the lowest associations were for their respective monotherapy. Looking at individual NSAIDs the highest association with GI events was observed for ketorolac exposure followed by nimesulide, diclofenac, aspirin, ketoprofen, and ibuprofen. This study highlights the primary role of the national spontaneous reporting system to bring out potential signals

  10. Reflective Database Access Control

    ERIC Educational Resources Information Center

    Olson, Lars E.

    2009-01-01

    "Reflective Database Access Control" (RDBAC) is a model in which a database privilege is expressed as a database query itself, rather than as a static privilege contained in an access control list. RDBAC aids the management of database access controls by improving the expressiveness of policies. However, such policies introduce new interactions…

  11. Databases: Beyond the Basics.

    ERIC Educational Resources Information Center

    Whittaker, Robert

    This presented paper offers an elementary description of database characteristics and then provides a survey of databases that may be useful to the teacher and researcher in Slavic and East European languages and literatures. The survey focuses on commercial databases that are available, usable, and needed. Individual databases discussed include:…

  12. A new data management system for the French National Registry of human alveolar echinococcosis cases.

    PubMed

    Charbonnier, Amandine; Knapp, Jenny; Demonmerot, Florent; Bresson-Hadni, Solange; Raoul, Francis; Grenouillet, Frédéric; Millon, Laurence; Vuitton, Dominique Angèle; Damy, Sylvie

    2014-01-01

    Alveolar echinococcosis (AE) is an endemic zoonosis in France due to the cestode Echinococcus multilocularis. The French National Reference Centre for Alveolar Echinococcosis (CNR-EA), connected to the FrancEchino network, is responsible for recording all AE cases diagnosed in France. Administrative, epidemiological and medical information on the French AE cases may currently be considered exhaustive only on the diagnosis time. To constitute a reference data set, an information system (IS) was developed thanks to a relational database management system (MySQL language). The current data set will evolve towards a dynamic surveillance system, including follow-up data (e.g. imaging, serology) and will be connected to environmental and parasitological data relative to E. multilocularis to better understand the pathogen transmission pathway. A particularly important goal is the possible interoperability of the IS with similar European and other databases abroad; this new IS could play a supporting role in the creation of new AE registries.

  13. A new data management system for the French National Registry of human alveolar echinococcosis cases

    PubMed Central

    Charbonnier, Amandine; Knapp, Jenny; Demonmerot, Florent; Bresson-Hadni, Solange; Raoul, Francis; Grenouillet, Frédéric; Millon, Laurence; Vuitton, Dominique Angèle; Damy, Sylvie

    2014-01-01

    Alveolar echinococcosis (AE) is an endemic zoonosis in France due to the cestode Echinococcus multilocularis. The French National Reference Centre for Alveolar Echinococcosis (CNR-EA), connected to the FrancEchino network, is responsible for recording all AE cases diagnosed in France. Administrative, epidemiological and medical information on the French AE cases may currently be considered exhaustive only on the diagnosis time. To constitute a reference data set, an information system (IS) was developed thanks to a relational database management system (MySQL language). The current data set will evolve towards a dynamic surveillance system, including follow-up data (e.g. imaging, serology) and will be connected to environmental and parasitological data relative to E. multilocularis to better understand the pathogen transmission pathway. A particularly important goal is the possible interoperability of the IS with similar European and other databases abroad; this new IS could play a supporting role in the creation of new AE registries. PMID:25526544

  14. Human Mitochondrial Protein Database

    National Institute of Standards and Technology Data Gateway

    SRD 131 Human Mitochondrial Protein Database (Web, free access)   The Human Mitochondrial Protein Database (HMPDb) provides comprehensive data on mitochondrial and human nuclear encoded proteins involved in mitochondrial biogenesis and function. This database consolidates information from SwissProt, LocusLink, Protein Data Bank (PDB), GenBank, Genome Database (GDB), Online Mendelian Inheritance in Man (OMIM), Human Mitochondrial Genome Database (mtDB), MITOMAP, Neuromuscular Disease Center and Human 2-D PAGE Databases. This database is intended as a tool not only to aid in studying the mitochondrion but in studying the associated diseases.

  15. [Validation of a measurement scale: example of a French Adverse Drug Reactions Preventability Scale].

    PubMed

    Olivier, Pascale; Caron, Jacques; Haramburu, Françoise; Imbs, Jean-Louis; Jonville-Béra, Annie-Pierre; Lagier, Georges; Sgro, Catherine; Vial, Thierry; Montastruc, Jean-Louis; Lapeyr-Mestre, Maryse

    2005-01-01

    Adverse drug reactions (ADRs) have been recognised as an important cause of hospital admission. Most of these drug-related admissions were expected ADRs and, thus, partly preventable. However, as far as we know, the assessment of the preventability of ADRs was addressed in only two studies performed in France. In contrast, several other studies have been performed, mainly in the USA, and using different methods of assessing preventability. None of these methods were clearly evaluated with regard to reproducibility, validity or relevance. The purpose of this study was to initiate the validation of a French preventability scale. Here, we propose the first two phases of validation: the content validity and reliability of the scale. A working group of pharmacovigilance experts has been specifically established for this purpose. The content validity was assessed by collecting items representative of preventability. The choice and the formulation of items and a proposal of a score (global and for each item) were adopted after the consensus of the experts. A definitive version of the ADR preventability scale was used for the assessment of reliability. During the second phase, experts independently tested the new scale from observations of ADRs (49 central nervous system haemorrhages with antivitamine K). The concordance of the experts' judgements was calculated using two statistical methods (Kappa statistic and correlation coefficient). The content validity phase was performed during several workshops where experts discussed the choice and formulation of the best items. We decided to construct a scale with a small number of items, allowing a rapid evaluation of the preventability of ADRs. On the basis of a global score, four categories of preventability of ADRs ("preventable", "potentially preventable", "unclassable", "not preventable" ADRs) were proposed. The agreement of experts regarding the global score was low, with a poor correlation coefficient value (coefficient

  16. [Human parasitoses in French Guiana].

    PubMed

    Carme, B

    2001-11-03

    MALARIA: This review summarises current knowledge of the epidemiological situation regarding parasitoses in French Guiana. Malaria is the most prevalent infection. The most common species is Plasmodium falciparum which is responsible for three quarters of all bouts of malaria. Plasmodium vivax is mostly present in endemic areas inhabited by Amerindian communities. Plasmodium malariae is rarer. CHAGAS' DISEASE, LEISHMAMIASIS AND TOXOPLASMOSIS: Four acute cases of cardiac Chagas' disease were observed between 1994 and 1996. These cases serve as a warning concerning the possible emergence of this type of parasitosis among the poor in Latin America. Cutaneous leishmaniasis is still highly endemic, with an incidence of about 2 cases per 1,000 inhabitants, which has remained essentially unchanged for 15 years. The identification of severe primary toxoplasmosis in immunocompetent individuals in recent years seems to be associated with an as yet poorly known, natural, Amazonian cycle. INTESTINAL PARASITOSES: Improvements in living conditions, hygiene and treatments are such that intestinal parasitoses, other than anguilluliasis, are no longer a major problem in the urban or coastal areas. The situation is very different in the central areas of the country and in the Amerindian and black half-cast communities, with high prevalences of ankylostomiasis (hookworm disease), anguilluliasis and amoebal disease (Entamoeba histolytica/E. dispar). OTHERS: Lymphatic filariasis is no longer endemic; tropical schistosomiasis and distomiasis have never been endemic. Parasitic pests (cutaneous larva migrans and insect or dust-mite ectoparasites) are more spectacular than severe, and constitute a classic "exotic" component of the spectrum of diseases in French Guiana.

  17. Multitemporal glacier inventory of the French Alps from the late 1960s to the late 2000s

    NASA Astrophysics Data System (ADS)

    Gardent, Marie; Rabatel, Antoine; Dedieu, Jean-Pierre; Deline, Philip

    2014-09-01

    The most recent and complete French glacier inventory was previously the Vivian database, dating from the end of the 1960s but incorporated in the World Glacier Inventory database at the end of the 1990s. Because of the important changes in glacier extent over recent decades an update of the inventory of glaciers of the French Alps was made in a digital vector format (with the associated database) for several dates covering the last 40 years. Such a multitemporal glacier inventory matches a key demand of the Global Terrestrial Network for Glaciers and the Global Land Ice Measurements from Space initiative (GLIMS). Topographical maps, aerial photographs and satellite images were used to map the extent of glaciers using both manual and automatic methods; and the database was generated considering the design of the GLIMS database. Glaciers in the French Alps covered 369 km2 in 1967/71, 340 km2 in 1985/86, 300 km2 in 2003, and 275 km2 in 2006/09. This represents a decrease in surface area of about 25% over the entire study period. Acceleration in glacier shrinkage during the study period was revealed, probably linked to the increase in average air temperature in the 20th century, which has been particularly pronounced since the 1970s. The behaviour of glaciers of the French Alps is in agreement with that of glaciers observed by other studies across the European Alps. We also report the distribution of the morpho-topographic variables (aspect, elevation, etc.) of glaciers of the French Alps for the period 2006/09, and analyse changes of these variables in the last four decades.

  18. Research Perspectives on Core French: A Literature Review

    ERIC Educational Resources Information Center

    Lapkin, Sharon; Mady, Callie; Arnott, Stephanie

    2009-01-01

    This article reviews the research literature on core French in three main areas: student diversity, delivery models for the core French program, and instructional approaches. These topics are put into context through a discussion of studies on community attitudes to French as a second language (FSL), dissatisfaction with core French outcomes and…

  19. Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database.

    PubMed

    Soukavong, Mick; Kim, Jungmee; Park, Kyounghoon; Yang, Bo Ram; Lee, Joongyub; Jin, Xue Mei; Park, Byung Joo

    2016-09-01

    We conducted pharmacovigilance data mining for a β-lactam antibiotics, amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. The AE which was detected by all the three indices of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) was defined as a signal. The KAERS database contained a total of 807,582 AE reports, among which 1,722 reports were attributed to amoxicillin. Among the 192,510 antibiotics-AE pairs, the number of amoxicillin-AE pairs was 2,913. Among 241 AEs, 52 adverse events were detected as amoxicillin signals. Comparing the drug labels of 9 countries, 12 adverse events including ineffective medicine, bronchitis, rhinitis, sinusitis, dry mouth, gastroesophageal reflux, hypercholesterolemia, gastric carcinoma, abnormal crying, induration, pulmonary carcinoma, and influenza-like symptoms were not listed on any of the labels of nine countries. In conclusion, we detected 12 new signals of amoxicillin which were not listed on the labels of 9 countries. Therefore, it should be followed by signal evaluation including causal association, clinical significance, and preventability.

  20. Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database

    PubMed Central

    2016-01-01

    We conducted pharmacovigilance data mining for a β-lactam antibiotics, amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. The AE which was detected by all the three indices of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) was defined as a signal. The KAERS database contained a total of 807,582 AE reports, among which 1,722 reports were attributed to amoxicillin. Among the 192,510 antibiotics-AE pairs, the number of amoxicillin-AE pairs was 2,913. Among 241 AEs, 52 adverse events were detected as amoxicillin signals. Comparing the drug labels of 9 countries, 12 adverse events including ineffective medicine, bronchitis, rhinitis, sinusitis, dry mouth, gastroesophageal reflux, hypercholesterolemia, gastric carcinoma, abnormal crying, induration, pulmonary carcinoma, and influenza-like symptoms were not listed on any of the labels of nine countries. In conclusion, we detected 12 new signals of amoxicillin which were not listed on the labels of 9 countries. Therefore, it should be followed by signal evaluation including causal association, clinical significance, and preventability. PMID:27510377

  1. Evolution of the prevalence of intestinal parasitic infections among the French armed forces in French Guiana.

    PubMed

    Christen, Jacques-Robert; Mura, Marie; Roudaut, Gwenaëlle; Drogoul, Anne-Sophie; Demar, Magalie; Briolant, Sébastien; Garnotel, Eric; Simon, Fabrice; Pommier De Santi, Vincent

    2016-07-01

    Two cross-sectional studies were performed 2 years apart in French military personnel deployed from France to French Guiana. In 2011, military medical centres in French Guiana reported 40 cases of intestinal parasitism in service members returning from illegal gold mining sites in the rainforest. In 2013, 48 out of 132 service members returning from French Guiana after a 4-month mission had eosinophilia and seven were infected with hookworm. A presumptive first-line treatment with albendazole could be the most pragmatic strategy.

  2. The longitudinal development of clusters in French.

    PubMed

    Demuth, Katherine; McCullough, Elizabeth

    2009-03-01

    Studies of English and German find that children tend to acquire word-final consonant clusters before word-initial consonant clusters. This order of acquisition is generally attributed to articulatory, frequency and/or morphological factors. This contrasts with recent experimental findings from French, where two-year-olds were better at producing word-initial than word-final clusters (Demuth & Kehoe, 2006). The purpose of the present study was to examine French-speaking children's longitudinal acquisition of clusters to determine if these results replicate developmentally. Analysis of spontaneous speech productions from two French-speaking children between one and three years confirmed the earlier acquisition of initial clusters, even when sonority factors were controlled. The findings suggest that French-speaking children acquire complexity at the beginnings of words before complexity appears word-finally. The role of frequency, morphological, structural and input factors is discussed.

  3. Translation and the Teacher of French

    ERIC Educational Resources Information Center

    Collins, H. S. Frank

    1977-01-01

    This article is a brief discussion of some exercises in guided translation and comparative analysis designed not only to increase students' competence in translation and knowledge of French but also to make them more attentive to their English. (CFM)

  4. Planthopper pests of grapevine (in French)

    Technology Transfer Automated Retrieval System (TEKTRAN)

    In the French vineyards occur two main insect pests belonging to Fulgoromorpha, Hyalesthes obsoletus Signoret (Cixiidae) and Metcalfa pruinosa (Say) (Flatidae). Hyalesthes obsoletus is inducing economic losses by transmitting a phytoplasma, called Stolbur, from wild plants (bindweed, nettle, etc.) t...

  5. Le Francais quand meme (French Nonetheless).

    ERIC Educational Resources Information Center

    Delautier, Jean-Marie

    1983-01-01

    Political, attitudinal, and administrative problems of teaching compulsory foreign languages in Colombia are described and discussed from the point of view of a French teacher in a system characterized by confusion and lack of student interest. (MSE)

  6. A Local Evaluation of Primary School French

    ERIC Educational Resources Information Center

    Nisbet, J. D.; Welsh, Jennifer

    1972-01-01

    A local study concludes that primary school French does not confer a lasting advantage but its contribution lies in the enlargement of interest rather that as a preparation for secondary school work. (JB)

  7. Physiological Information Database (PID)

    EPA Science Inventory

    EPA has developed a physiological information database (created using Microsoft ACCESS) intended to be used in PBPK modeling. The database contains physiological parameter values for humans from early childhood through senescence as well as similar data for laboratory animal spec...

  8. THE ECOTOX DATABASE

    EPA Science Inventory

    The database provides chemical-specific toxicity information for aquatic life, terrestrial plants, and terrestrial wildlife. ECOTOX is a comprehensive ecotoxicology database and is therefore essential for providing and suppoirting high quality models needed to estimate population...

  9. Ongoing pharmacovigilance on vaccines.

    PubMed

    Santuccio, Carmela; Trotta, Francesco; Felicetti, Patrizia

    2015-02-01

    Vaccines have peculiar characteristics as well as their surveillance. Specific requirements, needs and challenges for the vaccine vigilance are discussed in the perspective to improve the whole system in order to guarantee a safer vaccine use and the keeping of the public confidence in vaccinations. Key elements for the routine safety monitoring, new regulations and some available tools are taken into account. Finally, the Italian experience is shortly described.

  10. Management control literature and French public hospitals.

    PubMed

    Georgescu, Irène

    2013-08-01

    The introduction of activity based pricing in combination with hospitals' reorganizations has created a new financial logic in French public hospitals. The organization has an obligation to produce certain levels of activity, since hospitals' resources are directly dependent on the activity level. These changes also imply the implementation of financial results controls in these organizations. The purpose of this answer is to demonstrate how the literature on management control can help to understand what has been happening within the French public hospitals.

  11. French NATO Policy: The Next Five Years

    DTIC Science & Technology

    1990-06-01

    individual allies. 2See Bresson and Rosenzweig, 1988. -24- NUCLEAR FORCES The French are basing their defense planning on the assumption that a basic...Pillar in NATO?" Armed Forces Journal International, August 1988b. Bresson , Henri de, and Luc Rosenzweig, "La France et la RFA souhaitent une...Tribune, September 30, 1988c. Grant, Robert , "French Defense Policy and European Security," Political Science Quarterly, Vol. 100, No. 3, Fall 1985. Grosser

  12. Aviation Safety Issues Database

    NASA Technical Reports Server (NTRS)

    Morello, Samuel A.; Ricks, Wendell R.

    2009-01-01

    The aviation safety issues database was instrumental in the refinement and substantiation of the National Aviation Safety Strategic Plan (NASSP). The issues database is a comprehensive set of issues from an extremely broad base of aviation functions, personnel, and vehicle categories, both nationally and internationally. Several aviation safety stakeholders such as the Commercial Aviation Safety Team (CAST) have already used the database. This broader interest was the genesis to making the database publically accessible and writing this report.

  13. Scopus database: a review.

    PubMed

    Burnham, Judy F

    2006-03-08

    The Scopus database provides access to STM journal articles and the references included in those articles, allowing the searcher to search both forward and backward in time. The database can be used for collection development as well as for research. This review provides information on the key points of the database and compares it to Web of Science. Neither database is inclusive, but complements each other. If a library can only afford one, choice must be based in institutional needs.

  14. FRIPON, the French fireball network

    NASA Astrophysics Data System (ADS)

    Colas, F.; Zanda, B.; Bouley, S.; Vaubaillon, J.; Marmo, C.; Audureau, Y.; Kwon, M. K.; Rault, J. L.; Caminade, S.; Vernazza, P.; Gattacceca, J.; Birlan, M.; Maquet, L.; Egal, A.; Rotaru, M.; Gruson-Daniel, Y.; Birnbaum, C.; Cochard, F.; Thizy, O.

    2015-10-01

    FRIPON (Fireball Recovery and InterPlanetary Observation Network) [4](Colas et al, 2014) was recently founded by ANR (Agence Nationale de la Recherche). Its aim is to connect meteoritical science with asteroidal and cometary science in order to better understand solar system formation and evolution. The main idea is to set up an observation network covering all the French territory to collect a large number of meteorites (one or two per year) with accurate orbits, allowing us to pinpoint possible parent bodies. 100 all-sky cameras will be installed at the end of 2015 forming a dense network with an average distance of 100km between stations. To maximize the accuracy of orbit determination, we will mix our optical data with radar data from the GRAVES beacon received by 25 stations [5](Rault et al, 2015). As both the setting up of the network and the creation of search teams for meteorites will need manpower beyond our small team of professionals, we are developing a citizen science network called Vigie-Ciel [6](Zanda et al, 2015). The public at large will thus be able to simply use our data, participate in search campaigns or even setup their own cameras.

  15. JICST Factual Database

    NASA Astrophysics Data System (ADS)

    Hayase, Shuichi; Okano, Keiko

    Japan Information Center of Science and Technology (JICST) has started the on-line service of JICST Crystal Structure Database (JICST CR) in this January (1990). This database provides the information of atomic positions in a crystal and related informations of the crystal. The database system and the crystal data in JICST CR are outlined in this manuscript.

  16. The NCBI Taxonomy database.

    PubMed

    Federhen, Scott

    2012-01-01

    The NCBI Taxonomy database (http://www.ncbi.nlm.nih.gov/taxonomy) is the standard nomenclature and classification repository for the International Nucleotide Sequence Database Collaboration (INSDC), comprising the GenBank, ENA (EMBL) and DDBJ databases. It includes organism names and taxonomic lineages for each of the sequences represented in the INSDC's nucleotide and protein sequence databases. The taxonomy database is manually curated by a small group of scientists at the NCBI who use the current taxonomic literature to maintain a phylogenetic taxonomy for the source organisms represented in the sequence databases. The taxonomy database is a central organizing hub for many of the resources at the NCBI, and provides a means for clustering elements within other domains of NCBI web site, for internal linking between domains of the Entrez system and for linking out to taxon-specific external resources on the web. Our primary purpose is to index the domain of sequences as conveniently as possible for our user community.

  17. Third Semester College French, A Different Approach: Practical French for Careers.

    ERIC Educational Resources Information Center

    Rickert, Blandine

    An alternative approach used in a third semester French course at the University of Colorado at Denver is described. The approach was adopted to improve student motivation. The course focuses on the learning of practical French for everyday situations, while traveling abroad for business or pleasure. Emphasis is on conversational, communicative…

  18. Reformulation and the Learning of French Pronominal Verbs in a Canadian French Immersion Context.

    ERIC Educational Resources Information Center

    Lapkin, Sharon; Swain, Merrill; Smith, Monika

    2002-01-01

    Examines a subset of collaborative dialogues that occurred in a a multistage task where Canadian Grade 7 French immersion students worked together in pairs. Each pair wrote a story, noticed differences between their text and a reformulator's revision, and reflected on their noticing. Traces development of the target language (French), with…

  19. Hierarchies of Authenticity in Study Abroad: French from Canada versus French from France?

    ERIC Educational Resources Information Center

    Wernicke, Meike

    2016-01-01

    For many decades, Francophone regions in Canada have provided language study exchanges for French as a second language (FSL) learners within their own country. At the same time, FSL students and teachers in Canada continue to orient to a native speaker standard associated with European French. This Eurocentric orientation manifested itself in a…

  20. French from Four to Seven. A Handbook for Teaching French to the Very Young.

    ERIC Educational Resources Information Center

    Kodjak, Barbara Hippel

    The handbook is a compilation of ideas, strategies, resources, and suggestions for teaching French to children aged 4-7. It presupposes a school program in which French is taught as a foreign language for a brief period each day, although the ideas are adaptable to immersion instruction. Introductory sections describe the book's format and…

  1. IDPredictor: predict database links in biomedical database.

    PubMed

    Mehlhorn, Hendrik; Lange, Matthias; Scholz, Uwe; Schreiber, Falk

    2012-06-26

    Knowledge found in biomedical databases, in particular in Web information systems, is a major bioinformatics resource. In general, this biological knowledge is worldwide represented in a network of databases. These data is spread among thousands of databases, which overlap in content, but differ substantially with respect to content detail, interface, formats and data structure. To support a functional annotation of lab data, such as protein sequences, metabolites or DNA sequences as well as a semi-automated data exploration in information retrieval environments, an integrated view to databases is essential. Search engines have the potential of assisting in data retrieval from these structured sources, but fall short of providing a comprehensive knowledge except out of the interlinked databases. A prerequisite of supporting the concept of an integrated data view is to acquire insights into cross-references among database entities. This issue is being hampered by the fact, that only a fraction of all possible cross-references are explicitely tagged in the particular biomedical informations systems. In this work, we investigate to what extend an automated construction of an integrated data network is possible. We propose a method that predicts and extracts cross-references from multiple life science databases and possible referenced data targets. We study the retrieval quality of our method and report on first, promising results. The method is implemented as the tool IDPredictor, which is published under the DOI 10.5447/IPK/2012/4 and is freely available using the URL: http://dx.doi.org/10.5447/IPK/2012/4.

  2. French Gender "Rules" in the Speech of English-Dominant, French-Dominant and Monolingual French-Speaking Children. Working Papers on Bilingualism, No. 19.

    ERIC Educational Resources Information Center

    Harley, Birgit

    The French gender usage of grade two and grade five Franco-Ontarian children was compared with that of English-speaking children enrolled in French immersion programs, and monolingual French-speaking children in Quebec. While some of the Franco-Ontarian children are similar to the Quebec children with respect to the gender "rules" they…

  3. Agomelatine: a review of adverse effects.

    PubMed

    2013-03-01

    More pharmacovigilance data on agomelatine became available in 2012. The main sources of information were surveillance data from the French national monitoring system, EU periodic safety update reports (PSURs), and the European pharmacovigilance database. The principal adverse effects of agomelatine consist of hepatic, pancreatic, neuropsychiatric, muscular and cutaneous disorders. The harms associated with agomelatine, which has no proven efficacy in depression, clearly outweigh the benefits. Until regulatory agencies decide to withdraw agomelatine from the market, it is up to healthcare professionals to protect patients from this unnecessarily dangerous drug.

  4. An Introduction to Database Structure and Database Machines.

    ERIC Educational Resources Information Center

    Detweiler, Karen

    1984-01-01

    Enumerates principal management objectives of database management systems (data independence, quality, security, multiuser access, central control) and criteria for comparison (response time, size, flexibility, other features). Conventional database management systems, relational databases, and database machines used for backend processing are…

  5. 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

    PubMed Central

    Bhowmick, Subhrojyoti; Banerjee, Koyel; Sikdar, Shreya; Chatterjee, Tapan Kumar

    2014-01-01

    Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC) members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals) in Kolkata conducting active clinical research and having functional Ethics Committees (ECs) in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors' collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant. Results: Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43%) was found to be more than that of the medical members (68.75%), though the figure was not statistically significant. Majority of the members (75%) felt that EC should decide compensation in case of a serious adverse event. Conclusion: The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding pharmacovigilance

  6. 2010 Worldwide Gasification Database

    DOE Data Explorer

    The 2010 Worldwide Gasification Database describes the current world gasification industry and identifies near-term planned capacity additions. The database lists gasification projects and includes information (e.g., plant location, number and type of gasifiers, syngas capacity, feedstock, and products). The database reveals that the worldwide gasification capacity has continued to grow for the past several decades and is now at 70,817 megawatts thermal (MWth) of syngas output at 144 operating plants with a total of 412 gasifiers.

  7. ITS-90 Thermocouple Database

    National Institute of Standards and Technology Data Gateway

    SRD 60 NIST ITS-90 Thermocouple Database (Web, free access)   Web version of Standard Reference Database 60 and NIST Monograph 175. The database gives temperature -- electromotive force (emf) reference functions and tables for the letter-designated thermocouple types B, E, J, K, N, R, S and T. These reference functions have been adopted as standards by the American Society for Testing and Materials (ASTM) and the International Electrotechnical Commission (IEC).

  8. Veterans Administration Databases

    Cancer.gov

    The Veterans Administration Information Resource Center provides database and informatics experts, customer service, expert advice, information products, and web technology to VA researchers and others.

  9. Mugshot Identification Database (MID)

    National Institute of Standards and Technology Data Gateway

    NIST Mugshot Identification Database (MID) (PC database for purchase)   NIST Special Database 18 is being distributed for use in development and testing of automated mugshot identification systems. The database consists of three CD-ROMs, containing a total of 3248 images of variable size using lossless compression. A newer version of the compression/decompression software on the CDROM can be found at the website http://www.nist.gov/itl/iad/ig/nigos.cfm as part of the NBIS package.

  10. Databases for Microbiologists

    DOE PAGES

    Zhulin, Igor B.

    2015-05-26

    Databases play an increasingly important role in biology. They archive, store, maintain, and share information on genes, genomes, expression data, protein sequences and structures, metabolites and reactions, interactions, and pathways. All these data are critically important to microbiologists. Furthermore, microbiology has its own databases that deal with model microorganisms, microbial diversity, physiology, and pathogenesis. Thousands of biological databases are currently available, and it becomes increasingly difficult to keep up with their development. Finally, the purpose of this minireview is to provide a brief survey of current databases that are of interest to microbiologists.

  11. Databases for Microbiologists

    PubMed Central

    2015-01-01

    Databases play an increasingly important role in biology. They archive, store, maintain, and share information on genes, genomes, expression data, protein sequences and structures, metabolites and reactions, interactions, and pathways. All these data are critically important to microbiologists. Furthermore, microbiology has its own databases that deal with model microorganisms, microbial diversity, physiology, and pathogenesis. Thousands of biological databases are currently available, and it becomes increasingly difficult to keep up with their development. The purpose of this minireview is to provide a brief survey of current databases that are of interest to microbiologists. PMID:26013493

  12. HIV Sequence Databases

    PubMed Central

    Kuiken, Carla; Korber, Bette; Shafer, Robert W.

    2008-01-01

    Two important databases are often used in HIV genetic research, the HIV Sequence Database in Los Alamos, which collects all sequences and focuses on annotation and data analysis, and the HIV RT/Protease Sequence Database in Stanford, which collects sequences associated with the development of viral resistance against anti-retroviral drugs and focuses on analysis of those sequences. The types of data and services these two databases offer, the tools they provide, and the way they are set up and operated are described in detail. PMID:12875108

  13. The processing of singular and plural nouns in English, French, and Dutch: New insights from megastudies.

    PubMed

    Gimenes, Manuel; Brysbaert, Marc; New, Boris

    2016-12-01

    In this study, we explored the processing of singular and plural word forms, using megastudies in French, English, and Dutch. For singulars, we observed a base frequency effect but no surface frequency effect. For plurals, the effect depended on the frequency of the word form. When the word form had a frequency above a threshold value, we observed both surface and base frequency effects; for the frequencies below the threshold, we found a base frequency effect only, suggesting full decomposition for these words. The threshold differed between the languages, suggesting that more plurals are decomposed in French than in Dutch and more in Dutch than in English. In contrast, for all languages the singular form seems to be coactivated whenever the plural form is processed. These results are interpreted in light of some of the main models of morphological processing. (PsycINFO Database Record

  14. [French immigration policy at a turning point?].

    PubMed

    Wihtol De Wenden, C

    1995-01-01

    The author examines the changes to French immigration law adopted in 1993 in the light of current trends and pressures affecting migration to France. The focus is on the changes in the rules concerning the acquisition of French nationality, and the assimilation of existing immigrants from developing countries. The difficulties of resolving such problems at the national level while migration regulations are being developed at the European Community level are noted. Problems involving the control of the nation's borders, illegal immigration, and the growing demand for political asylum are also discussed. The author raises the possibility that immigration could be better managed in light of current labor market conditions in France.

  15. Vers un nouveau phonetisme francais (Toward a New French Phonetics)

    ERIC Educational Resources Information Center

    Monnot, Michel; Kite, Francoise

    1976-01-01

    Evolutionary changes in French pronunciation have necessitated changes in phonetic representation. The new articulatory phenomena involve modifications in syllabic structure and in consonant/vowel relationship. (Text is in French.) (DB)

  16. Adherence to Hypothermia Guidelines: A French Multicenter Study of Fullterm Neonates

    PubMed Central

    Chevallier, Marie; Ego, Anne; Cans, Christine; Debillon, Thierry

    2013-01-01

    Aim The objective of this study was to describe the French practice of hypothermia treatment (HT) in full-term newborns with hypoxic-ischemic encephalopathy (HIE) and to analyze the deviations from the guidelines of the French Society of Neonatology. Materials and Methods From May 2010 to March 2012 we recorded all cases of HIE treated by HT in a French national database. The population was divided into three groups, "optimal HT" (OHT), “late HT” (LHT) and “non-indicated” HT (NIHT), according to the guidelines. Results Of the 311 newborns registered in the database and having HT, 65% were classified in the OHT group, 22% and 13% in the LHT and NIHT groups respectively. The severity of asphyxia and HIE were comparable between newborns with OHT and LHT, apart from EEG. HT was initiated at a mean time of 12 hours of life in the LHT group. An acute obstetrical event was more likely to be identified among newborns with LHT (46%), compared to OHT (34%) and NIHT (22%). There was a gradation in the rate of complications from the NIHT group (29%) to the LHT (38%) group and the OHT group (52%). Despite an insignificant difference in the rates of death or abnormal neurological examination at discharge, nearly 60% of newborns in the OHT group had an MRI showing abnormalities, compared to 44% and 49% in the LHT and NIHT groups respectively. Conclusion The conduct of the HT for HIE newborns is not consistent with French guidelines for 35% of newborns, 22% being explained by an excessive delay in the start of HT, 13% by the lack of adherence to the clinical indications. This first report illustrates the difficulties in implementing guidelines for HT and should argue for an optimization of perinatal care for HIE. PMID:24391817

  17. Consumer Product Category Database

    EPA Pesticide Factsheets

    The Chemical and Product Categories database (CPCat) catalogs the use of over 40,000 chemicals and their presence in different consumer products. The chemical use information is compiled from multiple sources while product information is gathered from publicly available Material Safety Data Sheets (MSDS). EPA researchers are evaluating the possibility of expanding the database with additional product and use information.

  18. BioImaging Database

    SciTech Connect

    David Nix, Lisa Simirenko

    2006-10-25

    The Biolmaging Database (BID) is a relational database developed to store the data and meta-data for the 3D gene expression in early Drosophila embryo development on a cellular level. The schema was written to be used with the MySQL DBMS but with minor modifications can be used on any SQL compliant relational DBMS.

  19. Biological Macromolecule Crystallization Database

    National Institute of Standards and Technology Data Gateway

    SRD 21 Biological Macromolecule Crystallization Database (Web, free access)   The Biological Macromolecule Crystallization Database and NASA Archive for Protein Crystal Growth Data (BMCD) contains the conditions reported for the crystallization of proteins and nucleic acids used in X-ray structure determinations and archives the results of microgravity macromolecule crystallization studies.

  20. Online Database Searching Workbook.

    ERIC Educational Resources Information Center

    Littlejohn, Alice C.; Parker, Joan M.

    Designed primarily for use by first-time searchers, this workbook provides an overview of online searching. Following a brief introduction which defines online searching, databases, and database producers, five steps in carrying out a successful search are described: (1) identifying the main concepts of the search statement; (2) selecting a…

  1. HIV Structural Database

    National Institute of Standards and Technology Data Gateway

    SRD 102 HIV Structural Database (Web, free access)   The HIV Protease Structural Database is an archive of experimentally determined 3-D structures of Human Immunodeficiency Virus 1 (HIV-1), Human Immunodeficiency Virus 2 (HIV-2) and Simian Immunodeficiency Virus (SIV) Proteases and their complexes with inhibitors or products of substrate cleavage.

  2. Atomic Spectra Database (ASD)

    National Institute of Standards and Technology Data Gateway

    SRD 78 NIST Atomic Spectra Database (ASD) (Web, free access)   This database provides access and search capability for NIST critically evaluated data on atomic energy levels, wavelengths, and transition probabilities that are reasonably up-to-date. The NIST Atomic Spectroscopy Data Center has carried out these critical compilations.

  3. Structural Ceramics Database

    National Institute of Standards and Technology Data Gateway

    SRD 30 NIST Structural Ceramics Database (Web, free access)   The NIST Structural Ceramics Database (WebSCD) provides evaluated materials property data for a wide range of advanced ceramics known variously as structural ceramics, engineering ceramics, and fine ceramics.

  4. Morchella MLST database

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Welcome to the Morchella MLST database. This dedicated database was set up at the CBS-KNAW Biodiversity Center by Vincent Robert in February 2012, using BioloMICS software (Robert et al., 2011), to facilitate DNA sequence-based identifications of Morchella species via the Internet. The current datab...

  5. A Quality System Database

    NASA Technical Reports Server (NTRS)

    Snell, William H.; Turner, Anne M.; Gifford, Luther; Stites, William

    2010-01-01

    A quality system database (QSD), and software to administer the database, were developed to support recording of administrative nonconformance activities that involve requirements for documentation of corrective and/or preventive actions, which can include ISO 9000 internal quality audits and customer complaints.

  6. Knowledge Discovery in Databases.

    ERIC Educational Resources Information Center

    Norton, M. Jay

    1999-01-01

    Knowledge discovery in databases (KDD) revolves around the investigation and creation of knowledge, processes, algorithms, and mechanisms for retrieving knowledge from data collections. The article is an introductory overview of KDD. The rationale and environment of its development and applications are discussed. Issues related to database design…

  7. Ionic Liquids Database- (ILThermo)

    National Institute of Standards and Technology Data Gateway

    SRD 147 Ionic Liquids Database- (ILThermo) (Web, free access)   IUPAC Ionic Liquids Database, ILThermo, is a free web research tool that allows users worldwide to access an up-to-date data collection from the publications on experimental investigations of thermodynamic, and transport properties of ionic liquids as well as binary and ternary mixtures containing ionic liquids.

  8. Database Reviews: Legal Information.

    ERIC Educational Resources Information Center

    Seiser, Virginia

    Detailed reviews of two legal information databases--"Laborlaw I" and "Legal Resource Index"--are presented in this paper. Each database review begins with a bibliographic entry listing the title; producer; vendor; cost per hour contact time; offline print cost per citation; time period covered; frequency of updates; and size…

  9. A French Culture Course for Non-Language Majors.

    ERIC Educational Resources Information Center

    Savoie, Norman R.

    1987-01-01

    Utah State University changed its "potentially...boring and probably...useless" French civilization course (taught in French and required of majors) to an English-taught course for French majors and majors in business, economics, political science, and prelaw. The new course focuses on stereotypes, cultural differences, and current…

  10. French Security Policy in Transition: Dynamics of Continuity and Change

    DTIC Science & Technology

    1995-03-01

    significant social division requires a strong state. As a commentator on the French assessment in Entreprise France noted, the French analysts in this project... financement (Paris: The National Assembly, July 1993). 14 William T. Johnsen and Thomas-DareR Young, French Policy Toward NATO: Enhance Selectivity, Vice

  11. French Vocabulary--Looking for "le mot juste."

    ERIC Educational Resources Information Center

    Parris, David L.

    1996-01-01

    The apparent difficulty of students of French as a second language to acquire French vocabulary is examined, drawing on experience with teaching Irish university students and the structures and stylistic traits peculiar to French. It is noted that while certain kinds of words (noun, verb, adjective, adverb) occupy little space in text, they take…

  12. French Theory vs. Australian Praxis: The Sham in Tertiary Education.

    ERIC Educational Resources Information Center

    Winn, Philip

    1996-01-01

    Argues that the primary mode of expression of a significant proportion of contemporary literary and historical criticism (the stock in trade of Australian Arts faculties) is the French language. Emphasizes that knowledge of French prejudices and inclinations can only be gained by learning French. (two references) (Author/CK)

  13. Sources of French-Canadian Materials for Children.

    ERIC Educational Resources Information Center

    Aubrey, Irene E.

    This bibiography of reference sources for French-Canadian children's books includes bibliographies, indexes, a publishers' trade annual, recommended lists, and features in professional journals. The citations are presented alphabetically by title--in English, in French and English, or in French, depending on their source--and an address where it…

  14. Teaching French to Franco-Americans: A Controversial Problem.

    ERIC Educational Resources Information Center

    Hickel, Raymond A.

    1965-01-01

    A study of bilingualism among third-generation Americans of French-Canadian extraction briefly examines their linguistic superiority in French over monolingual students and appraises the appropriate psychological approaches to teaching this special group. The article suggests that an "educated standard French" be presented as an alternative to…

  15. On Translating French Occurring in English into Spanish.

    ERIC Educational Resources Information Center

    Sebastian, Robert N.

    1989-01-01

    Explores problems encountered during attempts to translate French expressions occurring in English (such as concierge) into Spanish, particularly when the English interpretation of the expression is different from the standard French usage. Spanish translations are provided for about 200 French terms and expressions commonly used in English. (61…

  16. Word Parsing by Late-Learning French-English Bilinguals.

    ERIC Educational Resources Information Center

    Golato, Peter

    2002-01-01

    Research on early learning French-English bilinguals suggests that development of segmentation is best characterized by a parameter-setting theory of language acquisition in which French segmentation is marked relative to English segmentation. Reports recent research with late-learning French-English bilinguals that finds evidence for parameter…

  17. 7 CFR 993.6 - Non-French prunes.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false Non-French prunes. 993.6 Section 993.6 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing Agreements... Order Regulating Handling Definitions § 993.6 Non-French prunes. Non-French prunes means prunes...

  18. Negation in Near-Native French: Variation and Sociolinguistic Competence

    ERIC Educational Resources Information Center

    Donaldson, Bryan

    2017-01-01

    This study investigated how adult second language (L2) speakers of French with near-native proficiency realize verbal negation, a well-known sociolinguistic variable in contemporary spoken French. Data included 10 spontaneous informal conversations between near-native speakers of French and native speakers (NSs) closely acquainted with them.…

  19. Discrimination of English and French Orthographic Patterns by Biliterate Children

    ERIC Educational Resources Information Center

    Jared, Debra; Cormier, Pierre; Levy, Betty Ann; Wade-Woolley, Lesly

    2013-01-01

    We investigated whether young English-French biliterate children can distinguish between English and French orthographic patterns. Children in French immersion programs were asked to play a dictionary game when they were in Grade 2 and again when they were in Grade 3. They were shown pseudowords that contained either an English spelling pattern or…

  20. Linguistic, Academic, and Cognitive Benefits of French Immersion

    ERIC Educational Resources Information Center

    Lazaruk, Wally

    2007-01-01

    A survey of research on French as a second language (FSL) education in Canada suggests that French immersion (FI) students enjoy significant linguistic, academic, and cognitive benefits. We organize our summary of the advantages of FI around these three themes, comparing students' proficiency in French and English across various FI programs, and…

  1. French: An Accommodating Language? = Le Francais: Langue D'Accueil?

    ERIC Educational Resources Information Center

    Wright, Sue, Ed.

    This bilingual book considers recent developments in French attitudes towards language purism, borrowing, and the incursion of English. The book begins with an essay by French sociolinguist Henriette Walter, and most of the following essays are direct responses to her ideas. All chapters are provided in French and English. Chapter titles include…

  2. Suggestions for the Organization of a Course in Commercial French

    ERIC Educational Resources Information Center

    Morton, Jacqueline

    1978-01-01

    Comments and suggestions are offered for organizing a class in commercial French. Two subjects must be taught: basic business transactions and procedures applicable to both the U.S. and France and French commercial terminology, stressing the differences between French and American practices. (SW)

  3. Un cours avance de francais: Le francais tel qu'on le parle (An Advanced Course in French: Colloquial French)

    ERIC Educational Resources Information Center

    Creusot, Andre

    1971-01-01

    Second of three articles on an advanced French program sponsored by the Language Department of the State University of Mons, Belgium. Emphasis is on the phonology, lexicology, and syntax of spoken French. (DS)

  4. Implemented data mining and signal management systems on spontaneous reporting systems' databases and their availability to the scientific community - a systematic review.

    PubMed

    de Almeida Vieira Lima, Luis Miguel; Nunes, Nuno Goncalo Sales Craveiro; da Silva Dias, Pedro Goncalo Pires; Marques, Francisco Jorge Batel

    2012-04-01

    Adverse drug reactions' spontaneous reporting systems are an important element in worldwide pharmacovigilance, gathering potentially useful information for post-marketing drug safety surveillance. Data mining and signal management systems, providing the capability of reading and interpreting these systems' raw data (data that has not been subjected to processing or any other manipulation), improve its analysis process. In order for this analysis to be possible, both data mining and signal management systems and raw data should be available to researchers and the scientific community. The purpose of this work was to provide an overview of the spontaneous reporting systems databases reported in literature as having implemented a data mining and signal management system and the implementation itself, evidencing their availability to researchers. A systematic review was carried out, concluding that they are freely provided to researchers within institutions responsible for maintaining the spontaneous reporting systems, but not to most researchers within the scientific community.

  5. Side effects of cade oil in Morocco: an analysis of reports in the Moroccan herbal products database from 2004 to 2012.

    PubMed

    Skalli, Souad; Chebat, Abderrahim; Badrane, Narjis; Bencheikh, Rachida Soulaymani

    2014-02-01

    Cade oil is a dark, faintly aromatic oil which is distilled from the branches and wood of Juniperus oxycedrus. Although this oil is known to have toxic effects related to its content of phenols, cade oil continues to be used in folk medicine. Because of this use, a determination of the safety and possible side effects of cade oil is required. The safety of cade oil is discussed based on the experience of the Moroccan pharmacovigilance herbal products database, and supported by literature. The data on the adverse effects of cade oil suggests that it could have life-threatening effects which can occur following topical exposure, ingestion or inhalation. Phenol's adverse effects involve a wide variety of organ systems such as the gastro-intestinal system, central and peripheral nervous systems, cardiovascular, liver and biliary systems, the urinary tract, skin and appendages, respiratory system. Platelet function, bleeding and clotting, vision, metabolism, and white cell and reticuloendothelial system function are also affected.

  6. Problems with French-English Business Dictionaries.

    ERIC Educational Resources Information Center

    Gartman, Max D.

    An analysis of two French-English business dictionaries, a 1989 revised edition and a 1990 edition, looks at a number of weaknesses in the resources' design and content. First, problems are found in transcriptions of pronunciation that do not reflect actual usage when it differs from convention and in lack of attention to pronunciation of words…

  7. Teaching French Culture. Theory and Practice.

    ERIC Educational Resources Information Center

    Steele, Ross; Suozzo, Andrew

    In today's global village, the choice of languages and cultures offered to the high school and college student in constantly increasing. Several reasons are offered for choosing the more traditional option of French/Francophone culture: internationalism, political contributions, intellectual achievements, France's role in Europe and in technology,…

  8. Attainment at 16+: the French Perspective

    ERIC Educational Resources Information Center

    Dundas-Grant, Valerie

    1975-01-01

    In the face of the deliberations that have been taking place in England for several years now about the merging of two '16+' examinations, the CSE and GCE Ordinary level, author investigated the French system and the examination, the BEPC, taken at 'intermediate' level by 'average' and 'above average' students. (Author/RK)

  9. French inside and outside the Classroom

    ERIC Educational Resources Information Center

    Crowell, Joseph

    2012-01-01

    Many teachers of foreign languages struggle with finding alternative ways of exposing their students to the target language. At Kent Gardens Elementary School (KGES) in McLean, Virginia, many students participate in an immersion program from first grade to sixth grade. These students spend half of every school day immersed in French while learning…

  10. Libraries of La Pocatiere: French Immersion Programs

    ERIC Educational Resources Information Center

    Kuntz, Patricia, S.

    2005-01-01

    Many times summer language immersion administrators and instructors overlook the rich collections housed in various town libraries. Students of French immersion programs have an opportunity to utilize local libraries. This essay describes the facilities and services of five libraries in La Pocatiere, Quebec. A series of interviews of librarians…

  11. Business French and the Liberal Arts.

    ERIC Educational Resources Information Center

    Newman, Michele O.

    The offering of a college course in French for industry and the professions revealed how well a business language course can serve the needs of language majors. The course served students in international marketing, management, finance, and a variety of liberal arts majors, including some language majors needing additional credits for graduation.…

  12. French Discourse Markers in Shaba Swahili Conversations.

    ERIC Educational Resources Information Center

    de Rooij, Vincent A.

    2000-01-01

    Examines data recorded in Shaba, a province in the Congo, and documents the marked preference to employ French discourse markers in Shaba Swahili discourse. Treats discourse markers as a special kind of contextualization cue that ties parts of a discourse to each other, creating cohesion and coherence. (Author/VWL)

  13. Connecting Research to French Mathematics Teacher Education.

    ERIC Educational Resources Information Center

    Robert, A.; Hache, C.

    2000-01-01

    Presents an overview of two surveys that focused on French teachers' classroom practices, the first of which provides an overview of the difficulties experienced by beginning teachers while the second survey provides a more detailed description of the classroom practices of experienced teachers. Proposes a research project on teacher professional…

  14. A Vous de Parler. French Trainee Book.

    ERIC Educational Resources Information Center

    Cole, Richard

    A set of instructional materials for French is designed for Peace Corps volunteer language instruction and geared to the daily language needs of volunteers in Morocco. It consists of 38 units containing mini-dialogues, related grammatical and cultural information, vocabulary, and exercises. Unit topics include introductions, information giving and…

  15. The Longitudinal Development of Clusters in French

    ERIC Educational Resources Information Center

    Demuth, Katherine; McCullough, Elizabeth

    2009-01-01

    Studies of English and German find that children tend to acquire word-final consonant clusters before word-initial consonant clusters. This order of acquisition is generally attributed to articulatory, frequency and/or morphological factors. This contrasts with recent experimental findings from French, where two-year-olds were better at producing…

  16. A French Vocabulary Tutor for the Web.

    ERIC Educational Resources Information Center

    Labrie, Gilles

    2000-01-01

    Discusses a project to design and implement a small French vocabulary tutor for the World Wide Web. Highlights salient features and design of the tutor and focuses on two variants of a module on technology-related vocabulary that were created using very straightforward html code and JavaScript. (Author/VWL)

  17. Clean Energy Solutions Center Services (French Translation)

    SciTech Connect

    2016-03-01

    This is a French translation of the Clean Energy Solutions Center fact sheet. The Solutions Center offers no-cost expert policy assistance, webinars and training forums, clean energy policy reports, data, and tools provided in partnership with more than 35 leading international and regional clean energy organizations.

  18. Le Francais Courant: Part V, French.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    Instructional objectives of the Dade County Public Schools Quinmester Program in French for use with "Le Francais Courant: Part 5" focus on the development of mastery of the basic numbering system and other grammatical structures. Structures include the formation of the present tense of the irregular verbs…

  19. Studies in French Grammar and Phonology.

    ERIC Educational Resources Information Center

    Benguerel, Andre-Pierre; Grundstrom, Allan W.

    The monograph contains two papers. The first presents a generative grammar for verbal forms in French. It consists of an ordered set of rewrite rules and a set of tables. It generates all existing verbal forms without generating any non-existing ones. The departure from an ordinary generative grammar lies in the use of a tabular form for…

  20. Study Guide for TCT in French.

    ERIC Educational Resources Information Center

    Brooks, J. Carroll; Bradley, C. Lee

    This study guide is specifically designed for those individuals preparing to take the Georgia Teacher Certification Test (TCT) in French language instruction. It covers four areas: (1) grammar; (2) usage; (3) history, geography, and literature; and (4) listening and oral skills. This guide provides prospective examinees with test content…

  1. 21 CFR 169.115 - French dressing.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... emulsified viscous fluid food prepared from vegetable oil(s) and one or both of the acidifying ingredients... this section may also be used. The vegetable oil(s) used may contain an optional crystallization... vegetable oil. French dressing may be mixed and packed in an atmosphere in which air is replaced in whole...

  2. 21 CFR 169.115 - French dressing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... emulsified viscous fluid food prepared from vegetable oil(s) and one or both of the acidifying ingredients... this section may also be used. The vegetable oil(s) used may contain an optional crystallization... vegetable oil. French dressing may be mixed and packed in an atmosphere in which air is replaced in whole...

  3. 21 CFR 169.115 - French dressing.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... emulsified viscous fluid food prepared from vegetable oil(s) and one or both of the acidifying ingredients... this section may also be used. The vegetable oil(s) used may contain an optional crystallization... vegetable oil. French dressing may be mixed and packed in an atmosphere in which air is replaced in whole...

  4. 21 CFR 169.115 - French dressing.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... emulsified viscous fluid food prepared from vegetable oil(s) and one or both of the acidifying ingredients... this section may also be used. The vegetable oil(s) used may contain an optional crystallization... vegetable oil. French dressing may be mixed and packed in an atmosphere in which air is replaced in whole...

  5. Capital Punishment for Juveniles: Albert French's "Billy."

    ERIC Educational Resources Information Center

    Darlington, Sonja

    1998-01-01

    Analyzes Albert French's novel "Billy" and its exploration of the United States' use of capital punishment for young criminals. Addresses the underlying causes of Billy's execution. Discusses specific themes and issues that teachers can use for classroom discussions of capital punishment. (RS)

  6. Using Conventional Sequences in L2 French

    ERIC Educational Resources Information Center

    Forsberg, Fanny

    2010-01-01

    By means of a phraseological identification method, this study provides a general description of the use of conventional sequences (CSs) in interviews at four different levels of spoken L2 French as well as in interviews with native speakers. Use of conventional sequences is studied with regard to overall quantity, category distribution and type…

  7. The French health care system: liberal universalism.

    PubMed

    Steffen, Monika

    2010-06-01

    This article analyzes the reforms introduced over the last quarter century into the French health care system. A particular public-private combination, rooted in French history and institutionalized through a specific division of the policy field between private doctors and public hospitals, explains the system's core characteristics: universal access, free choice, high quality, and a weak capacity for regulation. The dual architecture of this unique system leads to different reform strategies and outcomes in its two main parts. While the state has leverage in the hospital sector, it has failed repeatedly in attempts to regulate the ambulatory care sector. The first section of this article sets out the main characteristics and historical landmarks that continue to affect policy framing and implementation. Section 2 focuses on the evolution in financing and access, section 3 on management and governance in the (private) ambulatory care sector, and section 4 on the (mainly public) hospital sector. The conclusion compares the French model with those developed in the comparative literature and sets out the terms of the dilemma: a state-run social health insurance that lacks both the legitimacy of Bismarckian systems and the leverages of state-run systems. The French system therefore pursues contradictory policy goals, simultaneously developing universalism and liberalism, which explains both the direct state intervention and its limits.

  8. French Women in Physics: Status and Actions

    NASA Astrophysics Data System (ADS)

    Thibault, C.; Pépin, A.; Ducloy, M.; Giacobino, E.; Leduc, M.

    2009-04-01

    We present statistics on the underrepresentation of females entering scientific studies and on the persistence of a glass ceiling for women physicists—and female scientists in general—in France. We also examine actions taken by French research institutions, associations, companies, and professional societies since 2005 to improve these situations.

  9. Memory and Ideals in French Classrooms.

    ERIC Educational Resources Information Center

    Anderson-Levitt, Kathryn M.

    French elementary school teachers as well as the parents of their pupils remember being quiet students in teacher-dominated classrooms. Yet today both teachers and parents idealize lively classroom participation by their pupils or children. In this study, teachers and parents in an urban school district in Villefleurie, France, watched videotaped…

  10. Vocabulary Breadth in French L2 Learners

    ERIC Educational Resources Information Center

    David, Annabelle

    2008-01-01

    Vocabulary is one of the building blocks of language and is a necessary component of learners' development. This paper aims to describe the development of the L2 lexicon from the first year of learning French as a foreign language at school to the last year of undergraduate studies at university by setting out what learners know and how this…

  11. Films for French: A Teacher's Guide.

    ERIC Educational Resources Information Center

    Savignon, Sandra J., Ed.

    More than 100 films, selected for use in college-level French programs, are evaluated in this teaching guide. Films are listed alphabetically under the following categories: (1) "Beaux-Arts," (2) "La France Contemporaine," (3) "La France et le Nouveau Monde," (4) "Histoire," and (5) "Langue." The index gives an alphabetical list of all the films…

  12. Le Francais Moderne, (Modern French) Part II.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    Performance objectives and broad goals for listening, speaking, reading, and writing skills in French instruction are presented in this text. Cultural awareness and student attitude are also considered. Vocabulary and structure of the course are presented through three situations: shopping, meeting a train, and making vacation plans. Short films…

  13. The French Model of the Educator State.

    ERIC Educational Resources Information Center

    Lelievre, Claude

    2000-01-01

    The 19th-century emergence of a centralized, state-controlled school system helped stabilize government and legitimize a state model during a revolutionary period in French history. The centralized model assisted national integration goals by fabricating a symbolic public space. This ambitious political construction may be coming apart. (Contains…

  14. Le Francais Courant, Part VI: Contemporary French.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    This course, developed largely within the framework of units 13, 14, and 15 of the second edition of "A-LM French, Level 2," emphasizes development of basic audiolingual skills. Conversational topics permit the student to review his summer vacation. Principal elements of structure are expressions of quantity, pronouns--including those…

  15. The Autism Diagnostic Experiences of French Parents

    ERIC Educational Resources Information Center

    Chamak, Brigitte; Bonniau, Beatrice; Oudaya, Lila; Ehrenberg, Alain

    2011-01-01

    This survey focused on French parents' views of the diagnostic process relating to their child with autism. Data were collected on the age at diagnosis, the time taken to obtain a diagnosis and the difficulties encountered. Questionnaires filled in by the parents (n = 248) and in-depth interviews (n = 43) were analyzed in order to obtain…

  16. Using Drama in the French Immersion Program.

    ERIC Educational Resources Information Center

    Shacker, Deborah L.; And Others

    1993-01-01

    Analyzes the nature of the oral language interactions of French immersion students involved in a group drama about the early settlers. Finds that four language functions (informative, directive, expressive, and imaginative) were characteristic of children's interactions during group drama. Finds relationships between type of session and the…

  17. How to Find Out in: French.

    ERIC Educational Resources Information Center

    Robertson, Susan E.

    This library handbook is a guide for the student of French language and literature. It lists some of the more useful materials and reference books basic to general research and gives their locations in the Fogler Library at the University of Maine. Materials for language study include dictionaries and encyclopedias, histories of the language, and…

  18. [Relevance of the hemovigilance regional database for the shared medical file identity server].

    PubMed

    Doly, A; Fressy, P; Garraud, O

    2008-11-01

    The French Health Products Safety Agency coordinates the national initiative of computerization of blood products traceability within regional blood banks and public and private hospitals. The Auvergne-Loire Regional French Blood Service, based in Saint-Etienne, together with a number of public hospitals set up a transfusion data network named EDITAL. After four years of progressive implementation and experimentation, a software enabling standardized data exchange has built up a regional nominative database, endorsed by the Traceability Computerization National Committee in 2004. This database now provides secured web access to a regional transfusion history enabling biologists and all hospital and family practitioners to take in charge the patient follow-up. By running independently from the softwares of its partners, EDITAL database provides reference for the regional identity server.

  19. National Database of Geriatrics

    PubMed Central

    Kannegaard, Pia Nimann; Vinding, Kirsten L; Hare-Bruun, Helle

    2016-01-01

    Aim of database The aim of the National Database of Geriatrics is to monitor the quality of interdisciplinary diagnostics and treatment of patients admitted to a geriatric hospital unit. Study population The database population consists of patients who were admitted to a geriatric hospital unit. Geriatric patients cannot be defined by specific diagnoses. A geriatric patient is typically a frail multimorbid elderly patient with decreasing functional ability and social challenges. The database includes 14–15,000 admissions per year, and the database completeness has been stable at 90% during the past 5 years. Main variables An important part of the geriatric approach is the interdisciplinary collaboration. Indicators, therefore, reflect the combined efforts directed toward the geriatric patient. The indicators include Barthel index, body mass index, de Morton Mobility Index, Chair Stand, percentage of discharges with a rehabilitation plan, and the part of cases where an interdisciplinary conference has taken place. Data are recorded by doctors, nurses, and therapists in a database and linked to the Danish National Patient Register. Descriptive data Descriptive patient-related data include information about home, mobility aid, need of fall and/or cognitive diagnosing, and categorization of cause (general geriatric, orthogeriatric, or neurogeriatric). Conclusion The National Database of Geriatrics covers ∼90% of geriatric admissions in Danish hospitals and provides valuable information about a large and increasing patient population in the health care system. PMID:27822120

  20. Hazard Analysis Database Report

    SciTech Connect

    GRAMS, W.H.

    2000-12-28

    The Hazard Analysis Database was developed in conjunction with the hazard analysis activities conducted in accordance with DOE-STD-3009-94, Preparation Guide for U S . Department of Energy Nonreactor Nuclear Facility Safety Analysis Reports, for HNF-SD-WM-SAR-067, Tank Farms Final Safety Analysis Report (FSAR). The FSAR is part of the approved Authorization Basis (AB) for the River Protection Project (RPP). This document describes, identifies, and defines the contents and structure of the Tank Farms FSAR Hazard Analysis Database and documents the configuration control changes made to the database. The Hazard Analysis Database contains the collection of information generated during the initial hazard evaluations and the subsequent hazard and accident analysis activities. The Hazard Analysis Database supports the preparation of Chapters 3 ,4 , and 5 of the Tank Farms FSAR and the Unreviewed Safety Question (USQ) process and consists of two major, interrelated data sets: (1) Hazard Analysis Database: Data from the results of the hazard evaluations, and (2) Hazard Topography Database: Data from the system familiarization and hazard identification.

  1. Effectiveness of a Heritage Educational Program for the Acquisition of Oral and Written French and Tahitian in French Polynesia

    ERIC Educational Resources Information Center

    Nocus, Isabelle; Guimard, Philippe; Vernaudon, Jacques; Paia, Mirose; Cosnefroy, Olivier; Florin, Agnes

    2012-01-01

    The research examines the effects of a bilingual pedagogical program (French/Tahitian) on the acquisition of oral and written French as well as the Tahitian language itself in primary schools in French Polynesia. 125 children divided into an experimental group (partially schooled in Tahitian for 300 min per week) and a control group (schooled in…

  2. Switches to English during French Service Encounters: Relationships with L2 French Speakers' Willingness to Communicate and Motivation

    ERIC Educational Resources Information Center

    McNaughton, Stephanie; McDonough, Kim

    2015-01-01

    This exploratory study investigated second language (L2) French speakers' service encounters in the multilingual setting of Montreal, specifically whether switches to English during French service encounters were related to L2 speakers' willingness to communicate or motivation. Over a two-week period, 17 French L2 speakers in Montreal submitted…

  3. Glycoproteomic and glycomic databases.

    PubMed

    Baycin Hizal, Deniz; Wolozny, Daniel; Colao, Joseph; Jacobson, Elena; Tian, Yuan; Krag, Sharon S; Betenbaugh, Michael J; Zhang, Hui

    2014-01-01

    Protein glycosylation serves critical roles in the cellular and biological processes of many organisms. Aberrant glycosylation has been associated with many illnesses such as hereditary and chronic diseases like cancer, cardiovascular diseases, neurological disorders, and immunological disorders. Emerging mass spectrometry (MS) technologies that enable the high-throughput identification of glycoproteins and glycans have accelerated the analysis and made possible the creation of dynamic and expanding databases. Although glycosylation-related databases have been established by many laboratories and institutions, they are not yet widely known in the community. Our study reviews 15 different publicly available databases and identifies their key elements so that users can identify the most applicable platform for their analytical needs. These databases include biological information on the experimentally identified glycans and glycopeptides from various cells and organisms such as human, rat, mouse, fly and zebrafish. The features of these databases - 7 for glycoproteomic data, 6 for glycomic data, and 2 for glycan binding proteins are summarized including the enrichment techniques that are used for glycoproteome and glycan identification. Furthermore databases such as Unipep, GlycoFly, GlycoFish recently established by our group are introduced. The unique features of each database, such as the analytical methods used and bioinformatical tools available are summarized. This information will be a valuable resource for the glycobiology community as it presents the analytical methods and glycosylation related databases together in one compendium. It will also represent a step towards the desired long term goal of integrating the different databases of glycosylation in order to characterize and categorize glycoproteins and glycans better for biomedical research.

  4. Impact of Resident Rotations on Critically Ill Patient Outcomes: Results of a French Multicenter Observational Study

    PubMed Central

    Guidet, Bertrand; Aegerter, Philippe; Mentec, Hervé

    2016-01-01

    Purpose The impact of resident rotation on patient outcomes in the intensive care unit (ICU) has been poorly studied. The aim of this study was to address this question using a large ICU database. Methods We retrospectively analyzed the French CUB-REA database. French residents rotate every six months. Two periods were compared: the first (POST) and fifth (PRE) months of the rotation. The primary endpoint was ICU mortality. The secondary endpoints were the length of ICU stay (LOS), the number of organ supports, and the duration of mechanical ventilation (DMV). The impact of resident rotation was explored using multivariate regression, classification tree and random forest models. Results 262,772 patients were included between 1996 and 2010 in the database. The patient characteristics were similar between the PRE (n = 44,431) and POST (n = 49,979) periods. Multivariate analysis did not reveal any impact of resident rotation on ICU mortality (OR = 1.01, 95% CI = 0.94; 1.07, p = 0.91). Based on the classification trees, the SAPS II and the number of organ failures were the strongest predictors of ICU mortality. In the less severe patients (SAPS II<24), the POST period was associated with increased mortality (OR = 1.65, 95%CI = 1.17–2.33, p = 0.004). After adjustment, no significant association was observed between the rotation period and the LOS, the number of organ supports, or the DMV. Conclusion Resident rotation exerts no impact on overall ICU mortality at French teaching hospitals but might affect the prognosis of less severe ICU patients. Surveillance should be reinforced when treating those patients. PMID:27627449

  5. Phase Equilibria Diagrams Database

    National Institute of Standards and Technology Data Gateway

    SRD 31 NIST/ACerS Phase Equilibria Diagrams Database (PC database for purchase)   The Phase Equilibria Diagrams Database contains commentaries and more than 21,000 diagrams for non-organic systems, including those published in all 21 hard-copy volumes produced as part of the ACerS-NIST Phase Equilibria Diagrams Program (formerly titled Phase Diagrams for Ceramists): Volumes I through XIV (blue books); Annuals 91, 92, 93; High Tc Superconductors I & II; Zirconium & Zirconia Systems; and Electronic Ceramics I. Materials covered include oxides as well as non-oxide systems such as chalcogenides and pnictides, phosphates, salt systems, and mixed systems of these classes.

  6. JICST Factual Database

    NASA Astrophysics Data System (ADS)

    Suzuki, Kazuaki; Shimura, Kazuki; Monma, Yoshio; Sakamoto, Masao; Morishita, Hiroshi; Kanazawa, Kenji

    The Japan Information Center of Science and Technology (JICST) has started the on-line service of JICST/NRIM Materials Strength Database for Engineering Steels and Alloys (JICST ME) in this March (1990). This database has been developed under the joint research between JICST and the National Research Institute for Metals (NRIM). It provides material strength data (creep, fatigue, etc.) of engineering steels and alloys. It is able to search and display on-line, and to analyze the searched data statistically and plot the result on graphic display. The database system and the data in JICST ME are described.

  7. Plant Genome Duplication Database.

    PubMed

    Lee, Tae-Ho; Kim, Junah; Robertson, Jon S; Paterson, Andrew H

    2017-01-01

    Genome duplication, widespread in flowering plants, is a driving force in evolution. Genome alignments between/within genomes facilitate identification of homologous regions and individual genes to investigate evolutionary consequences of genome duplication. PGDD (the Plant Genome Duplication Database), a public web service database, provides intra- or interplant genome alignment information. At present, PGDD contains information for 47 plants whose genome sequences have been released. Here, we describe methods for identification and estimation of dates of genome duplication and speciation by functions of PGDD.The database is freely available at http://chibba.agtec.uga.edu/duplication/.

  8. Numeric Databases in the Sciences.

    ERIC Educational Resources Information Center

    Meschel, S. V.

    1984-01-01

    Provides exploration into types of numeric databases available (also known as source databases, nonbibliographic databases, data-files, data-banks, fact banks); examines differences and similarities between bibliographic and numeric databases; identifies disciplines that utilize numeric databases; and surveys representative examples in the…

  9. [Coverage of the chikungunya epidemic on Reunion Island in 2006 by the French healthcare system].

    PubMed

    Lagacherie, P

    2012-03-01

    The chikungunya epidemic that occurred on Reunion Island between 2005 and 2006 was covered by the French health insurance system. This coverage involved a major increase in the number of paid sick leave days and prescription drug refunds in the first quarter of 2006. Special governmental measures such as full reimbursement of certain medications and waiving of the waiting period for sick leave in case of relapse greatly reduced the impact of the epidemic. Five years after, the database of the health insurance systems indicates a low incidence of chronic forms. Only cases managed on an outpatient basis were included in this study.

  10. Risk stratification of thyroid nodules on ultrasonography with the French TI-RADS: description and reflections

    PubMed Central

    2016-01-01

    The widespread use of ultrasonography places it in a key position for use in the risk stratification of thyroid nodules. The French proposal is a five-tier system, our version of a thyroid imaging reporting and database system (TI-RADS), which includes a standardized vocabulary and report and a quantified risk assessment. It allows the selection of the nodules that should be referred for fine-needle aspiration biopsies. Effort should be directed towards merging the different risk stratification systems utilized around the world and testing this unified system with multi-center studies. PMID:26324117

  11. THE CTEPP DATABASE

    EPA Science Inventory

    The CTEPP (Children's Total Exposure to Persistent Pesticides and Other Persistent Organic Pollutants) database contains a wealth of data on children's aggregate exposures to pollutants in their everyday surroundings. Chemical analysis data for the environmental media and ques...

  12. Chemical Kinetics Database

    National Institute of Standards and Technology Data Gateway

    SRD 17 NIST Chemical Kinetics Database (Web, free access)   The NIST Chemical Kinetics Database includes essentially all reported kinetics results for thermal gas-phase chemical reactions. The database is designed to be searched for kinetics data based on the specific reactants involved, for reactions resulting in specified products, for all the reactions of a particular species, or for various combinations of these. In addition, the bibliography can be searched by author name or combination of names. The database contains in excess of 38,000 separate reaction records for over 11,700 distinct reactant pairs. These data have been abstracted from over 12,000 papers with literature coverage through early 2000.

  13. Hawaii bibliographic database

    NASA Astrophysics Data System (ADS)

    Wright, Thomas L.; Takahashi, Taeko Jane

    The Hawaii bibliographic database has been created to contain all of the literature, from 1779 to the present, pertinent to the volcanological history of the Hawaiian-Emperor volcanic chain. References are entered in a PC- and Macintosh-compatible EndNote Plus bibliographic database with keywords and s or (if no ) with annotations as to content. Keywords emphasize location, discipline, process, identification of new chemical data or age determinations, and type of publication. The database is updated approximately three times a year and is available to upload from an ftp site. The bibliography contained 8460 references at the time this paper was submitted for publication. Use of the database greatly enhances the power and completeness of library searches for anyone interested in Hawaiian volcanism.

  14. Enhancing medical database security.

    PubMed

    Pangalos, G; Khair, M; Bozios, L

    1994-08-01

    A methodology for the enhancement of database security in a hospital environment is presented in this paper which is based on both the discretionary and the mandatory database security policies. In this way the advantages of both approaches are combined to enhance medical database security. An appropriate classification of the different types of users according to their different needs and roles and a User Role Definition Hierarchy has been used. The experience obtained from the experimental implementation of the proposed methodology in a major general hospital is briefly discussed. The implementation has shown that the combined discretionary and mandatory security enforcement effectively limits the unauthorized access to the medical database, without severely restricting the capabilities of the system.

  15. Uranium Location Database Compilation

    EPA Pesticide Factsheets

    EPA has compiled mine location information from federal, state, and Tribal agencies into a single database as part of its investigation into the potential environmental hazards of wastes from abandoned uranium mines in the western United States.

  16. Livestock Anaerobic Digester Database

    EPA Pesticide Factsheets

    The Anaerobic Digester Database provides basic information about anaerobic digesters on livestock farms in the United States, organized in Excel spreadsheets. It includes projects that are under construction, operating, or shut down.

  17. Hawaii bibliographic database

    USGS Publications Warehouse

    Wright, T.L.; Takahashi, T.J.

    1998-01-01

    The Hawaii bibliographic database has been created to contain all of the literature, from 1779 to the present, pertinent to the volcanological history of the Hawaiian-Emperor volcanic chain. References are entered in a PC- and Macintosh-compatible EndNote Plus bibliographic database with keywords and abstracts or (if no abstract) with annotations as to content. Keywords emphasize location, discipline, process, identification of new chemical data or age determinations, and type of publication. The database is updated approximately three times a year and is available to upload from an ftp site. The bibliography contained 8460 references at the time this paper was submitted for publication. Use of the database greatly enhances the power and completeness of library searches for anyone interested in Hawaiian volcanism.

  18. Nuclear Science References Database

    SciTech Connect

    Pritychenko, B.; Běták, E.; Singh, B.; Totans, J.

    2014-06-15

    The Nuclear Science References (NSR) database together with its associated Web interface, is the world's only comprehensive source of easily accessible low- and intermediate-energy nuclear physics bibliographic information for more than 210,000 articles since the beginning of nuclear science. The weekly-updated NSR database provides essential support for nuclear data evaluation, compilation and research activities. The principles of the database and Web application development and maintenance are described. Examples of nuclear structure, reaction and decay applications are specifically included. The complete NSR database is freely available at the websites of the National Nuclear Data Center (http://www.nndc.bnl.gov/nsr) and the International Atomic Energy Agency (http://www-nds.iaea.org/nsr)

  19. ARTI Refrigerant Database

    SciTech Connect

    Calm, J.M.

    1994-05-27

    The Refrigerant Database consolidates and facilitates access to information to assist industry in developing equipment using alternative refrigerants. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern.

  20. Querying genomic databases

    SciTech Connect

    Baehr, A.; Hagstrom, R.; Joerg, D.; Overbeek, R.

    1991-09-01

    A natural-language interface has been developed that retrieves genomic information by using a simple subset of English. The interface spares the biologist from the task of learning database-specific query languages and computer programming. Currently, the interface deals with the E. coli genome. It can, however, be readily extended and shows promise as a means of easy access to other sequenced genomic databases as well.

  1. Database computing in HEP

    SciTech Connect

    Day, C.T.; Loken, S.; MacFarlane, J.F. ); May, E.; Lifka, D.; Lusk, E.; Price, L.E. ); Baden, A. . Dept. of Physics); Grossman, R.; Qin, X. . Dept. of Mathematics, Statistics and Computer Science); Cormell, L.; Leibold, P.; Liu, D

    1992-01-01

    The major SSC experiments are expected to produce up to 1 Petabyte of data per year each. Once the primary reconstruction is completed by farms of inexpensive processors. I/O becomes a major factor in further analysis of the data. We believe that the application of database techniques can significantly reduce the I/O performed in these analyses. We present examples of such I/O reductions in prototype based on relational and object-oriented databases of CDF data samples.

  2. Human mapping databases.

    PubMed

    Talbot, C; Cuticchia, A J

    2001-05-01

    This unit concentrates on the data contained within two human genome databasesGDB (Genome Database) and OMIM (Online Mendelian Inheritance in Man)and includes discussion of different methods for submitting and accessing data. An understanding of electronic mail, FTP, and the use of a World Wide Web (WWW) navigational tool such as Netscape or Internet Explorer is a prerequisite for utilizing the information in this unit.

  3. Steam Properties Database

    National Institute of Standards and Technology Data Gateway

    SRD 10 NIST/ASME Steam Properties Database (PC database for purchase)   Based upon the International Association for the Properties of Water and Steam (IAPWS) 1995 formulation for the thermodynamic properties of water and the most recent IAPWS formulations for transport and other properties, this updated version provides water properties over a wide range of conditions according to the accepted international standards.

  4. The comprehensive peptaibiotics database.

    PubMed

    Stoppacher, Norbert; Neumann, Nora K N; Burgstaller, Lukas; Zeilinger, Susanne; Degenkolb, Thomas; Brückner, Hans; Schuhmacher, Rainer

    2013-05-01

    Peptaibiotics are nonribosomally biosynthesized peptides, which - according to definition - contain the marker amino acid α-aminoisobutyric acid (Aib) and possess antibiotic properties. Being known since 1958, a constantly increasing number of peptaibiotics have been described and investigated with a particular emphasis on hypocrealean fungi. Starting from the existing online 'Peptaibol Database', first published in 1997, an exhaustive literature survey of all known peptaibiotics was carried out and resulted in a list of 1043 peptaibiotics. The gathered information was compiled and used to create the new 'The Comprehensive Peptaibiotics Database', which is presented here. The database was devised as a software tool based on Microsoft (MS) Access. It is freely available from the internet at http://peptaibiotics-database.boku.ac.at and can easily be installed and operated on any computer offering a Windows XP/7 environment. It provides useful information on characteristic properties of the peptaibiotics included such as peptide category, group name of the microheterogeneous mixture to which the peptide belongs, amino acid sequence, sequence length, producing fungus, peptide subfamily, molecular formula, and monoisotopic mass. All these characteristics can be used and combined for automated search within the database, which makes The Comprehensive Peptaibiotics Database a versatile tool for the retrieval of valuable information about peptaibiotics. Sequence data have been considered as to December 14, 2012.

  5. Drinking Water Database

    NASA Technical Reports Server (NTRS)

    Murray, ShaTerea R.

    2004-01-01

    This summer I had the opportunity to work in the Environmental Management Office (EMO) under the Chemical Sampling and Analysis Team or CS&AT. This team s mission is to support Glenn Research Center (GRC) and EM0 by providing chemical sampling and analysis services and expert consulting. Services include sampling and chemical analysis of water, soil, fbels, oils, paint, insulation materials, etc. One of this team s major projects is the Drinking Water Project. This is a project that is done on Glenn s water coolers and ten percent of its sink every two years. For the past two summers an intern had been putting together a database for this team to record the test they had perform. She had successfully created a database but hadn't worked out all the quirks. So this summer William Wilder (an intern from Cleveland State University) and I worked together to perfect her database. We began be finding out exactly what every member of the team thought about the database and what they would change if any. After collecting this data we both had to take some courses in Microsoft Access in order to fix the problems. Next we began looking at what exactly how the database worked from the outside inward. Then we began trying to change the database but we quickly found out that this would be virtually impossible.

  6. The Transporter Classification Database

    PubMed Central

    Saier, Milton H.; Reddy, Vamsee S.; Tamang, Dorjee G.; Västermark, Åke

    2014-01-01

    The Transporter Classification Database (TCDB; http://www.tcdb.org) serves as a common reference point for transport protein research. The database contains more than 10 000 non-redundant proteins that represent all currently recognized families of transmembrane molecular transport systems. Proteins in TCDB are organized in a five level hierarchical system, where the first two levels are the class and subclass, the second two are the family and subfamily, and the last one is the transport system. Superfamilies that contain multiple families are included as hyperlinks to the five tier TC hierarchy. TCDB includes proteins from all types of living organisms and is the only transporter classification system that is both universal and recognized by the International Union of Biochemistry and Molecular Biology. It has been expanded by manual curation, contains extensive text descriptions providing structural, functional, mechanistic and evolutionary information, is supported by unique software and is interconnected to many other relevant databases. TCDB is of increasing usefulness to the international scientific community and can serve as a model for the expansion of database technologies. This manuscript describes an update of the database descriptions previously featured in NAR database issues. PMID:24225317

  7. Specialist Bibliographic Databases.

    PubMed

    Gasparyan, Armen Yuri; Yessirkepov, Marlen; Voronov, Alexander A; Trukhachev, Vladimir I; Kostyukova, Elena I; Gerasimov, Alexey N; Kitas, George D

    2016-05-01

    Specialist bibliographic databases offer essential online tools for researchers and authors who work on specific subjects and perform comprehensive and systematic syntheses of evidence. This article presents examples of the established specialist databases, which may be of interest to those engaged in multidisciplinary science communication. Access to most specialist databases is through subscription schemes and membership in professional associations. Several aggregators of information and database vendors, such as EBSCOhost and ProQuest, facilitate advanced searches supported by specialist keyword thesauri. Searches of items through specialist databases are complementary to those through multidisciplinary research platforms, such as PubMed, Web of Science, and Google Scholar. Familiarizing with the functional characteristics of biomedical and nonbiomedical bibliographic search tools is mandatory for researchers, authors, editors, and publishers. The database users are offered updates of the indexed journal lists, abstracts, author profiles, and links to other metadata. Editors and publishers may find particularly useful source selection criteria and apply for coverage of their peer-reviewed journals and grey literature sources. These criteria are aimed at accepting relevant sources with established editorial policies and quality controls.

  8. Specialist Bibliographic Databases

    PubMed Central

    2016-01-01

    Specialist bibliographic databases offer essential online tools for researchers and authors who work on specific subjects and perform comprehensive and systematic syntheses of evidence. This article presents examples of the established specialist databases, which may be of interest to those engaged in multidisciplinary science communication. Access to most specialist databases is through subscription schemes and membership in professional associations. Several aggregators of information and database vendors, such as EBSCOhost and ProQuest, facilitate advanced searches supported by specialist keyword thesauri. Searches of items through specialist databases are complementary to those through multidisciplinary research platforms, such as PubMed, Web of Science, and Google Scholar. Familiarizing with the functional characteristics of biomedical and nonbiomedical bibliographic search tools is mandatory for researchers, authors, editors, and publishers. The database users are offered updates of the indexed journal lists, abstracts, author profiles, and links to other metadata. Editors and publishers may find particularly useful source selection criteria and apply for coverage of their peer-reviewed journals and grey literature sources. These criteria are aimed at accepting relevant sources with established editorial policies and quality controls. PMID:27134485

  9. Crude Oil Analysis Database

    DOE Data Explorer

    Shay, Johanna Y.

    The composition and physical properties of crude oil vary widely from one reservoir to another within an oil field, as well as from one field or region to another. Although all oils consist of hydrocarbons and their derivatives, the proportions of various types of compounds differ greatly. This makes some oils more suitable than others for specific refining processes and uses. To take advantage of this diversity, one needs access to information in a large database of crude oil analyses. The Crude Oil Analysis Database (COADB) currently satisfies this need by offering 9,056 crude oil analyses. Of these, 8,500 are United States domestic oils. The database contains results of analysis of the general properties and chemical composition, as well as the field, formation, and geographic location of the crude oil sample. [Taken from the Introduction to COAMDATA_DESC.pdf, part of the zipped software and database file at http://www.netl.doe.gov/technologies/oil-gas/Software/database.html] Save the zipped file to your PC. When opened, it will contain PDF documents and a large Excel spreadsheet. It will also contain the database in Microsoft Access 2002.

  10. The French language virtual medical university.

    PubMed

    Morin, A; Benhamou, A C; Spector, M; Bonnin, A; Debry, C

    2004-01-01

    The work program of the French Language Virtual Medical University started about 2 years ago, and entered into a real active phase of development and implementation in 2002. Various national programs and organizational initiatives should accelerate and facilitate further appropriation of modem pedagogical approaches by knowledge providers and all users of the FSVMU, so as to advance on the way of virtual education. The French Language Virtual Medical University under the auspices of both the National Conference of Deans of Medical Schools and the International Conference of Deans of French-Speaking Medical Schools has been developed to create a major Internet portal for French-speaking distance medical learning and teaching. This construct should be representative of all medical schools in France and French-speaking countries. Contents will also be translated into English, Spanish and Arabic. All medical disciplines with their various levels of teaching are to be included. Cross-related fields are also going to be present in order to offer full range programs. The latter are intended to provide both initial and continuing education for medical students as well as all other categories of health professionals and medical and scientific research workers. To develop the appropriate technology and make such a portal, on one hand correspond to the specific educational requirements and proper training for health professionals, and on the other hand provide a general access to e-learning in all schools of medicine; in keeping with such goals, the following approaches should be stressed upon. To build a virtual space where individual patients, their families, patient associations as well as the general public, can obtain medical information of good quality for the purposes of both education and prevention. Providing such categories with reliable and validated sources of information, and offering an ethical basis for the increasing practice of e-medicine, represent in today

  11. Databases: Peter's Picks and Pans.

    ERIC Educational Resources Information Center

    Jacso, Peter

    1995-01-01

    Reviews the best and worst in databases on disk, CD-ROM, and online, and offers judgments and observations on database characteristics. Two databases are praised and three are criticized. (Author/JMV)

  12. From pharmacovigilance to therapy amelioration in paediatric patients: the role of the clinical pharmacologists and family paediatricians. Part of a series on Paediatric Pharmacology, guest edited by Gianvincenzo Zuccotti, Emilio Clementi, and Massimo Molteni.

    PubMed

    Napoleone, Ettore; Radice, Sonia

    2012-02-01

    An active pharmacovigilance approach is advisable in paediatric pharmacotherapy as it contributes to generate knowledge promptly and to enhance the estimation of true risk in clinical practice. Reports and studies from the scientific community and regulatory agencies have shown that effective methods for early detection of adverse drug reaction and pharmacoepidemiological studies are a primary need since they increase drug safety in the paediatric population. In this perspective article we describe how pharmacologists and paediatricians may actively synergise to optimise drug therapies and their management in paediatric patients.

  13. French Pro/Am collaborations in exoplanet

    NASA Astrophysics Data System (ADS)

    Santerne, A.; Moutou, C.; Vanhuysse, M.; Bouchy, F.; Buil, C.; Cochard, F.; Thizy, O.; Martinez, P.; Desnoux, V.; Pujol, M.; Colas, F.

    2011-10-01

    Amateur astronomers have access to huge telescope time and can reach photometric precision up to a few mmag as well as radial velocity precision up to ˜ 50m.s-1 on brightest stars. We will first present some results of french amateur astronomers in transit photometry and radial velocity and then, we will present an over-view of all the collaborations which can be done between professional and amateur astronomers in the competitive exoplanet domain, and especially the current collaboration between french Pro & Am astronomers which was used in publication in A&A. Finally, we will present a new internet wiki page which goal is to develop such collaboration in different countries.

  14. [Thalassemia in French-speaking Quebec residents].

    PubMed

    Desjardins, L; Rousseau, C; Duplain, J M; Valet, J P; Auger, P

    1978-10-07

    Eighty-five cases of beta-thalassemia minor were found between January 1975 and November 1977 in 18 families of French-speaking Quebeckers without Mediterranean ancestry. Most of the families had settled in Quebec more than 200 years ago, largely in Portneuf county. This is the first report of such a number of cases of beta-thalassemia in this population. Thus, beta-thalassemia minor is a relatively common condition in Quebec and must be considered in cases of microcytic anemia without evidence of iron deficiency. The hematologic findings were similar to those reported in the past in other populations. Two cases of delta beta-thalassemia minor (in sisters) are also reported; this is the first report of such cases in French Canadians.

  15. French language space science educational outreach

    NASA Astrophysics Data System (ADS)

    Schofield, I.; Masongsong, E. V.; Connors, M. G.

    2015-12-01

    Athabasca University's AUTUMNX ground-based magnetometer array to measure and report geomagnetic conditions in eastern Canada is located in the heart of French speaking Canada. Through the course of the project, we have had the privilege to partner with schools, universities, astronomy clubs and government agencies across Quebec, all of which operate primarily in French. To acknowledge and serve the needs of our research partners, we have endeavored to produce educational and outreach (EPO) material adapted for francophone audiences with the help of UCLA's department of Earth, Planetary and Space Sciences (EPSS). Not only will this provide greater understanding and appreciation of the geospace environment unique to Quebec and surrounding regions, it strengthens our ties with our francophone, first nations (native Americans) and Inuit partners, trailblazing new paths of research collaboration and inspiring future generations of researchers.

  16. Productivity of lexical categories in French-speaking children with cochlear implants.

    PubMed

    Le Normand, M-T; Ouellet, C; Cohen, H

    2003-11-01

    The productivity of lexical categories was studied longitudinally in a sample of 17 young hearing-impaired French-speaking children with cochlear implants. Age of implantation ranged from 22 months to 76 months. Spontaneous speech samples were collected at six-month intervals over a period of 36 months, starting at the one-word stage. Four general measures of their linguistic production (number of utterances, verbal fluency, vocabulary, and grammatical production) as well as 36 specific lexical categories, according to the CHILDES codes, were computed in terms of tokens, i.e., total number of words. Cochlear-implanted children (CI) were compared to a French database of normally hearing children aged 2-4 compiled by the first author. Follow-up results indicate that, at the two-year post-implantation follow-up, noun, and verb morphology was significantly impaired. At the three-year follow-up, the cochlear-implanted group had recovered on adjectives, determiners and nouns, main verbs, and auxiliaries. The two groups differed significantly in processing locative adverbs, prepositions, pronouns, and verbs (infinitive verb, modal, and modal lexical), but individual variability within the cochlear-implanted group was substantial. Results are discussed in terms of recovery and developmental trends and variability in the acquisition of lexical categories by French children two years and three years post-implantation.

  17. Great Basin paleontological database

    USGS Publications Warehouse

    Zhang, N.; Blodgett, R.B.; Hofstra, A.H.

    2008-01-01

    The U.S. Geological Survey has constructed a paleontological database for the Great Basin physiographic province that can be served over the World Wide Web for data entry, queries, displays, and retrievals. It is similar to the web-database solution that we constructed for Alaskan paleontological data (www.alaskafossil.org). The first phase of this effort was to compile a paleontological bibliography for Nevada and portions of adjacent states in the Great Basin that has recently been completed. In addition, we are also compiling paleontological reports (Known as E&R reports) of the U.S. Geological Survey, which are another extensive source of l,egacy data for this region. Initial population of the database benefited from a recently published conodont data set and is otherwise focused on Devonian and Mississippian localities because strata of this age host important sedimentary exhalative (sedex) Au, Zn, and barite resources and enormons Carlin-type An deposits. In addition, these strata are the most important petroleum source rocks in the region, and record the transition from extension to contraction associated with the Antler orogeny, the Alamo meteorite impact, and biotic crises associated with global oceanic anoxic events. The finished product will provide an invaluable tool for future geologic mapping, paleontological research, and mineral resource investigations in the Great Basin, making paleontological data acquired over nearly the past 150 yr readily available over the World Wide Web. A description of the structure of the database and the web interface developed for this effort are provided herein. This database is being used ws a model for a National Paleontological Database (which we am currently developing for the U.S. Geological Survey) as well as for other paleontological databases now being developed in other parts of the globe. ?? 2008 Geological Society of America.

  18. U.S.-French Commercial Ties

    DTIC Science & Technology

    2008-05-19

    France has been the sixth largest market for U.S. exports of services. Although trade in goods and services receive most of the attention in terms of the...impact on sales of products such as French wines, perfumes and toiletries, travel goods and handbags, and cheeses that are most prone to being...from the United States. Yet, prompted by mandates of the European Union’s Single Market , the need to reduce budget deficits by raising revenues

  19. The Development of French Nuclear Forces

    DTIC Science & Technology

    1987-11-01

    the following issues : 1) restoration of pre-war status 2) restoration of French confidence 3) past and present concerns about dependency on alliances...casual 4 observer to be a nation or fine wines, excellent cuisine , contemporary fashion, fine furniture, classic art, and a revolutionary heritage. But... issues like the development of nuclear weapons is best described by 7 Lawrence Scheinman in Atomic Energy Policy in France Under the Fourth Republic

  20. Forest management strategies for reducing carbon emissions, the French case

    NASA Astrophysics Data System (ADS)

    Valade, Aude; Luyssaert, Sebastiaan; Bellassen, Valentin; Vallet, Patrick; Martin, Manuel

    2015-04-01

    International agreements now recognize the role of forest in the mitigation of climate change through the levers of in-situ sequestration, storage in products and energy and product substitution. These three strategies of carbon management are often antagonistic and it is still not clear which strategy would have the most significant impact on atmospheric carbon concentrations. With a focus on France, this study compares several scenarios of forest management in terms of their effect on the overall carbon budget from trees to wood-products. We elaborated four scenarios of forest management that target different wood production objectives. One scenario is 'Business as usual' and reproduces the current forest management and wood production levels. Two scenarios target an increase in bioenergy wood production, with either long-term or short-term goals. One scenario aims at increasing the production of timber for construction. For this, an empirical regression model was developed building on the rich French inventory database. The model can project the current forest resource at a time horizon of 20 years for characteristic variables diameter, standing volume, above-ground biomass, stand age. A simplified life-cycle analysis provides a full carbon budget for each scenario from forest management to wood use and allows the identification of the scenario that most reduces carbon emissions.

  1. An inventory of trace elements inputs to French agricultural soils.

    PubMed

    Belon, E; Boisson, M; Deportes, I Z; Eglin, T K; Feix, I; Bispo, A O; Galsomies, L; Leblond, S; Guellier, C R

    2012-11-15

    The inputs of ten trace elements (As, Cd, Cu, Cr, Hg, Mo, Ni, Pb, Se, Zn) to French agricultural soils have been assessed. The six main sources considered were: pesticides, mineral fertilizers, animal manure, liming materials, sludge and composts and atmospheric deposition. Data were collected to compute inputs at both national and regional (departmental) scales. The inventory methodology is based on two principles: data are traceable and easy to update. At a national scale, the inventory showed that trace elements inputs can be ranked: Zn≫Cu≫Cr>Pb>Ni>As=Mo>Se>Cd>Hg. Animal manure, mineral fertilizers and pesticides are the predominant sources of TEs. These results are globally in agreement with literature data though atmospheric deposition is shown to be lower than in more industrial countries such as China and United Kingdom where similar surveys were conducted. The inputs of trace elements vary strongly between regions in relation with agricultural activities. This inventory (and the related database) provides basis for developing and monitoring policies to control and reduce trace elements contamination of agricultural soils at both national and regional (departmental) scales.

  2. [The origins of the French neurosurgery].

    PubMed

    Brunon, J

    2016-06-01

    Modern French neurosurgery starts at the beginning of the XXth century under the motivation of Joseph Babinski. He submitted his patients to Thierry de Martel who had learned this new specialized area of medicine with H. Cushing in the États-Unis and V. Horsey in Great Britain. His first successfully treated case of an intracranial tumor was published in 1909. But the true founding father was Clovis Vincent, initially a neurologist and collaborator of de Martel, who became the first chairman in 1933 of the neurosurgical department at the Pitié hospital of Paris and the first professor of neurosurgery in 1938. After the Second World War, many departments were created outside of Paris. Neurosurgery was definitively recognized as a specialized area in medicine in 1948. Currently, more than 400 neurosurgeons work in France. Because I had the very great privilege to be present at the birth of this society in 1970 and to still be in contact with some of the second and third generation of French neurosurgeons who led it to its high international recognition, the Chairman of the French Neurosurgical Society asked me to write this short historical vignette.

  3. Malaria control strategies in French armed forces.

    PubMed

    Migliani, R; Pradines, B; Michel, R; Aoun, O; Dia, A; Deparis, X; Rapp, C

    2014-01-01

    Each year, 40,000 French soldiers deploy or travel through malaria-endemic areas. Despite the effective control measures that were successively implemented, malaria remains a public health concern in French armed forces with several important outbreaks and one lethal case every two years. This article describes the malaria control strategy in French armed forces which is based on three combined strategies: i) Anopheles vector control to prevent infection with the implementation of personal protection against vectors (PPAV) adapted to the field living conditions of the troops. ii) Chemoprophylaxis (CP) to prevent the disease based on prescription of effective and well tolerated doxycycline. iii) Management of cases through early diagnosis and appropriate treatment to prevent death. In isolated conditions in endemic areas, rapid diagnosis tests (RDT) are used as first-line tests by military doctors. Treatment of uncomplicated Plasmodium falciparum (P. falciparum) malaria is based either on the piperaquine tetraphosphate-dihydroartemisinin association since 2013, or on the atovaquone-proguanil association. First-line treatment of severe P. falciparum malaria is based on IV artesunate. These measures are associated with constant education of the military, epidemiological surveillance of malaria cases and monitoring of parasite chemosensitivity.

  4. Societal risk as seen by the French public

    SciTech Connect

    Karpowicz-Lazreg, C.; Mullet, E. )

    1993-06-01

    Mean risk magnitude judgments expressed by French students on 90 hazardous activities are reported and compared with findings on American, Hungarian, and Norwegian samples. In many respects, rating of perceived risk in the French sample is highly comparable to rating in American subjects. American and French people tend to share the same preoccupations to the same extent. The only major differences concern hallucinatory drugs and oral contraceptives. The Norwegians and French ratings differ much more. Norwegians and French people generally have the same preoccupations (which make Norwegian ratings the best predictor of French ratings) but not to the same extent. The French are much more concerned with a whole series of activities connected to violence, the implementation of high technology or agricultural technology. However, like the Norwegians, the French are extremely concerned about the spread of hallucinogenic drugs. The Hungarian and French ratings differ on practically all instances, except on basic activities or substances in all industrialized nations (caffeine, motorcycles, ...). Differences were observed within the French sample itself. Women more than men consider that home appliances in general and large-scale public transportation are potentially dangerous. Science students more than art students tend to fear a certain number of medical techniques and a certain number of toxic substances (e.g., smoking). 7 refs., 1 tab.

  5. NASA Records Database

    NASA Technical Reports Server (NTRS)

    Callac, Christopher; Lunsford, Michelle

    2005-01-01

    The NASA Records Database, comprising a Web-based application program and a database, is used to administer an archive of paper records at Stennis Space Center. The system begins with an electronic form, into which a user enters information about records that the user is sending to the archive. The form is smart : it provides instructions for entering information correctly and prompts the user to enter all required information. Once complete, the form is digitally signed and submitted to the database. The system determines which storage locations are not in use, assigns the user s boxes of records to some of them, and enters these assignments in the database. Thereafter, the software tracks the boxes and can be used to locate them. By use of search capabilities of the software, specific records can be sought by box storage locations, accession numbers, record dates, submitting organizations, or details of the records themselves. Boxes can be marked with such statuses as checked out, lost, transferred, and destroyed. The system can generate reports showing boxes awaiting destruction or transfer. When boxes are transferred to the National Archives and Records Administration (NARA), the system can automatically fill out NARA records-transfer forms. Currently, several other NASA Centers are considering deploying the NASA Records Database to help automate their records archives.

  6. ADANS database specification

    SciTech Connect

    1997-01-16

    The purpose of the Air Mobility Command (AMC) Deployment Analysis System (ADANS) Database Specification (DS) is to describe the database organization and storage allocation and to provide the detailed data model of the physical design and information necessary for the construction of the parts of the database (e.g., tables, indexes, rules, defaults). The DS includes entity relationship diagrams, table and field definitions, reports on other database objects, and a description of the ADANS data dictionary. ADANS is the automated system used by Headquarters AMC and the Tanker Airlift Control Center (TACC) for airlift planning and scheduling of peacetime and contingency operations as well as for deliberate planning. ADANS also supports planning and scheduling of Air Refueling Events by the TACC and the unit-level tanker schedulers. ADANS receives input in the form of movement requirements and air refueling requests. It provides a suite of tools for planners to manipulate these requirements/requests against mobility assets and to develop, analyze, and distribute schedules. Analysis tools are provided for assessing the products of the scheduling subsystems, and editing capabilities support the refinement of schedules. A reporting capability provides formatted screen, print, and/or file outputs of various standard reports. An interface subsystem handles message traffic to and from external systems. The database is an integral part of the functionality summarized above.

  7. The Chandra Bibliography Database

    NASA Astrophysics Data System (ADS)

    Rots, A. H.; Winkelman, S. L.; Paltani, S.; Blecksmith, S. E.; Bright, J. D.

    2004-07-01

    Early in the mission, the Chandra Data Archive started the development of a bibliography database, tracking publications in refereed journals and on-line conference proceedings that are based on Chandra observations, allowing our users to link directly to articles in the ADS from our archive, and to link to the relevant data in the archive from the ADS entries. Subsequently, we have been working closely with the ADS and other data centers, in the context of the ADEC-ITWG, on standardizing the literature-data linking. We have also extended our bibliography database to include all Chandra-related articles and we are also keeping track of the number of citations of each paper. Obviously, in addition to providing valuable services to our users, this database allows us to extract a wide variety of statistical information. The project comprises five components: the bibliography database-proper, a maintenance database, an interactive maintenance tool, a user browsing interface, and a web services component for exchanging information with the ADS. All of these elements are nearly mission-independent and we intend make the package as a whole available for use by other data centers. The capabilities thus provided represent support for an essential component of the Virtual Observatory.

  8. FishTraits Database

    USGS Publications Warehouse

    Angermeier, Paul L.; Frimpong, Emmanuel A.

    2009-01-01

    The need for integrated and widely accessible sources of species traits data to facilitate studies of ecology, conservation, and management has motivated development of traits databases for various taxa. In spite of the increasing number of traits-based analyses of freshwater fishes in the United States, no consolidated database of traits of this group exists publicly, and much useful information on these species is documented only in obscure sources. The largely inaccessible and unconsolidated traits information makes large-scale analysis involving many fishes and/or traits particularly challenging. FishTraits is a database of >100 traits for 809 (731 native and 78 exotic) fish species found in freshwaters of the conterminous United States, including 37 native families and 145 native genera. The database contains information on four major categories of traits: (1) trophic ecology, (2) body size and reproductive ecology (life history), (3) habitat associations, and (4) salinity and temperature tolerances. Information on geographic distribution and conservation status is also included. Together, we refer to the traits, distribution, and conservation status information as attributes. Descriptions of attributes are available here. Many sources were consulted to compile attributes, including state and regional species accounts and other databases.

  9. Shuttle Hypervelocity Impact Database

    NASA Technical Reports Server (NTRS)

    Hyde, James L.; Christiansen, Eric L.; Lear, Dana M.

    2011-01-01

    With three missions outstanding, the Shuttle Hypervelocity Impact Database has nearly 3000 entries. The data is divided into tables for crew module windows, payload bay door radiators and thermal protection system regions, with window impacts compromising just over half the records. In general, the database provides dimensions of hypervelocity impact damage, a component level location (i.e., window number or radiator panel number) and the orbiter mission when the impact occurred. Additional detail on the type of particle that produced the damage site is provided when sampling data and definitive analysis results are available. Details and insights on the contents of the database including examples of descriptive statistics will be provided. Post flight impact damage inspection and sampling techniques that were employed during the different observation campaigns will also be discussed. Potential enhancements to the database structure and availability of the data for other researchers will be addressed in the Future Work section. A related database of returned surfaces from the International Space Station will also be introduced.

  10. Shuttle Hypervelocity Impact Database

    NASA Technical Reports Server (NTRS)

    Hyde, James I.; Christiansen, Eric I.; Lear, Dana M.

    2011-01-01

    With three flights remaining on the manifest, the shuttle impact hypervelocity database has over 2800 entries. The data is currently divided into tables for crew module windows, payload bay door radiators and thermal protection system regions, with window impacts compromising just over half the records. In general, the database provides dimensions of hypervelocity impact damage, a component level location (i.e., window number or radiator panel number) and the orbiter mission when the impact occurred. Additional detail on the type of particle that produced the damage site is provided when sampling data and definitive analysis results are available. The paper will provide details and insights on the contents of the database including examples of descriptive statistics using the impact data. A discussion of post flight impact damage inspection and sampling techniques that were employed during the different observation campaigns will be presented. Future work to be discussed will be possible enhancements to the database structure and availability of the data for other researchers. A related database of ISS returned surfaces that are under development will also be introduced.

  11. VIEWCACHE: An incremental database access method for autonomous interoperable databases

    NASA Technical Reports Server (NTRS)

    Roussopoulos, Nick; Sellis, Timoleon

    1991-01-01

    The objective is to illustrate the concept of incremental access to distributed databases. An experimental database management system, ADMS, which has been developed at the University of Maryland, in College Park, uses VIEWCACHE, a database access method based on incremental search. VIEWCACHE is a pointer-based access method that provides a uniform interface for accessing distributed databases and catalogues. The compactness of the pointer structures formed during database browsing and the incremental access method allow the user to search and do inter-database cross-referencing with no actual data movement between database sites. Once the search is complete, the set of collected pointers pointing to the desired data are dereferenced.

  12. Open Geoscience Database

    NASA Astrophysics Data System (ADS)

    Bashev, A.

    2012-04-01

    Currently there is an enormous amount of various geoscience databases. Unfortunately the only users of the majority of the databases are their elaborators. There are several reasons for that: incompaitability, specificity of tasks and objects and so on. However the main obstacles for wide usage of geoscience databases are complexity for elaborators and complication for users. The complexity of architecture leads to high costs that block the public access. The complication prevents users from understanding when and how to use the database. Only databases, associated with GoogleMaps don't have these drawbacks, but they could be hardly named "geoscience" Nevertheless, open and simple geoscience database is necessary at least for educational purposes (see our abstract for ESSI20/EOS12). We developed a database and web interface to work with them and now it is accessible at maps.sch192.ru. In this database a result is a value of a parameter (no matter which) in a station with a certain position, associated with metadata: the date when the result was obtained; the type of a station (lake, soil etc); the contributor that sent the result. Each contributor has its own profile, that allows to estimate the reliability of the data. The results can be represented on GoogleMaps space image as a point in a certain position, coloured according to the value of the parameter. There are default colour scales and each registered user can create the own scale. The results can be also extracted in *.csv file. For both types of representation one could select the data by date, object type, parameter type, area and contributor. The data are uploaded in *.csv format: Name of the station; Lattitude(dd.dddddd); Longitude(ddd.dddddd); Station type; Parameter type; Parameter value; Date(yyyy-mm-dd). The contributor is recognised while entering. This is the minimal set of features that is required to connect a value of a parameter with a position and see the results. All the complicated data

  13. Decomposability and mental representation of French verbs

    PubMed Central

    Estivalet, Gustavo L.; Meunier, Fanny E.

    2015-01-01

    In French, regardless of stem regularity, inflectional verbal suffixes are extremely regular and paradigmatic. Considering the complexity of the French verbal system, we argue that all French verbs are polymorphemic forms that are decomposed during visual recognition independently of their stem regularity. We conducted a behavioral experiment in which we manipulated the surface and cumulative frequencies of verbal inflected forms and asked participants to perform a visual lexical decision task. We tested four types of verbs with respect to their stem variants: a. fully regular (parler “to speak,” [parl-]); b. phonological change e/E verbs with orthographic markers (répéter “to repeat,” [répét-] and [répèt-]); c. phonological change o/O verbs without orthographic markers (adorer “to adore,” [ador-] and [adOr-]); and d. idiosyncratic (boire “to drink,” [boi-] and [buv-]). For each type of verb, we contrasted four conditions, forms with high and low surface frequencies and forms with high and low cumulative frequencies. Our results showed a significant cumulative frequency effect for the fully regular and idiosyncratic verbs, indicating that different stems within idiosyncratic verbs (such as [boi-] and [buv-]) have distinct representations in the mental lexicon as different fully regular verbs. For the phonological change verbs, we found a significant cumulative frequency effect only when considering the two forms of the stem together ([répét-] and [répèt-]), suggesting that they share a single abstract and under specified phonological representation. Our results also revealed a significant surface frequency effect for all types of verbs, which may reflect the recombination of the stem lexical representation with the functional information of the suffixes. Overall, these results indicate that all inflected verbal forms in French are decomposed during visual recognition and that this process could be due to the regularities of the French

  14. ARTI Refrigerant Database

    SciTech Connect

    Calm, J.M.

    1992-04-30

    The Refrigerant Database consolidates and facilitates access to information to assist industry in developing equipment using alternative refrigerants. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern. The database provides bibliographic citations and abstracts for publications that may be useful in research and design of air- conditioning and refrigeration equipment. The complete documents are not included, though some may be added at a later date. The database identifies sources of specific information on R-32, R-123, R-124, R- 125, R-134a, R-141b, R142b, R-143a, R-152a, R-290 (propane), R-717 (ammonia), ethers, and others as well as azeotropic and zeotropic blends of these fluids. It addresses polyalkylene glycol (PAG), ester, and other lubricants. It also references documents addressing compatibility of refrigerants and lubricants with metals, plastics, elastomers, motor insulation, and other materials used in refrigerant circuits.

  15. The PROSITE database

    PubMed Central

    Hulo, Nicolas; Bairoch, Amos; Bulliard, Virginie; Cerutti, Lorenzo; De Castro, Edouard; Langendijk-Genevaux, Petra S.; Pagni, Marco; Sigrist, Christian J. A.

    2006-01-01

    The PROSITE database consists of a large collection of biologically meaningful signatures that are described as patterns or profiles. Each signature is linked to a documentation that provides useful biological information on the protein family, domain or functional site identified by the signature. The PROSITE database is now complemented by a series of rules that can give more precise information about specific residues. During the last 2 years, the documentation and the ScanProsite web pages were redesigned to add more functionalities. The latest version of PROSITE (release 19.11 of September 27, 2005) contains 1329 patterns and 552 profile entries. Over the past 2 years more than 200 domains have been added, and now 52% of UniProtKB/Swiss-Prot entries (release 48.1 of September 27, 2005) have a cross-reference to a PROSITE entry. The database is accessible at . PMID:16381852

  16. Medical database security evaluation.

    PubMed

    Pangalos, G J

    1993-01-01

    Users of medical information systems need confidence in the security of the system they are using. They also need a method to evaluate and compare its security capabilities. Every system has its own requirements for maintaining confidentiality, integrity and availability. In order to meet these requirements a number of security functions must be specified covering areas such as access control, auditing, error recovery, etc. Appropriate confidence in these functions is also required. The 'trust' in trusted computer systems rests on their ability to prove that their secure mechanisms work as advertised and cannot be disabled or diverted. The general framework and requirements for medical database security and a number of parameters of the evaluation problem are presented and discussed. The problem of database security evaluation is then discussed, and a number of specific proposals are presented, based on a number of existing medical database security systems.

  17. Mouse genome database 2016

    PubMed Central

    Bult, Carol J.; Eppig, Janan T.; Blake, Judith A.; Kadin, James A.; Richardson, Joel E.

    2016-01-01

    The Mouse Genome Database (MGD; http://www.informatics.jax.org) is the primary community model organism database for the laboratory mouse and serves as the source for key biological reference data related to mouse genes, gene functions, phenotypes and disease models with a strong emphasis on the relationship of these data to human biology and disease. As the cost of genome-scale sequencing continues to decrease and new technologies for genome editing become widely adopted, the laboratory mouse is more important than ever as a model system for understanding the biological significance of human genetic variation and for advancing the basic research needed to support the emergence of genome-guided precision medicine. Recent enhancements to MGD include new graphical summaries of biological annotations for mouse genes, support for mobile access to the database, tools to support the annotation and analysis of sets of genes, and expanded support for comparative biology through the expansion of homology data. PMID:26578600

  18. Mouse genome database 2016.

    PubMed

    Bult, Carol J; Eppig, Janan T; Blake, Judith A; Kadin, James A; Richardson, Joel E

    2016-01-04

    The Mouse Genome Database (MGD; http://www.informatics.jax.org) is the primary community model organism database for the laboratory mouse and serves as the source for key biological reference data related to mouse genes, gene functions, phenotypes and disease models with a strong emphasis on the relationship of these data to human biology and disease. As the cost of genome-scale sequencing continues to decrease and new technologies for genome editing become widely adopted, the laboratory mouse is more important than ever as a model system for understanding the biological significance of human genetic variation and for advancing the basic research needed to support the emergence of genome-guided precision medicine. Recent enhancements to MGD include new graphical summaries of biological annotations for mouse genes, support for mobile access to the database, tools to support the annotation and analysis of sets of genes, and expanded support for comparative biology through the expansion of homology data.

  19. Enhancing medical database semantics.

    PubMed Central

    Leão, B. de F.; Pavan, A.

    1995-01-01

    Medical Databases deal with dynamic, heterogeneous and fuzzy data. The modeling of such complex domain demands powerful semantic data modeling methodologies. This paper describes GSM-Explorer a Case Tool that allows for the creation of relational databases using semantic data modeling techniques. GSM Explorer fully incorporates the Generic Semantic Data Model-GSM enabling knowledge engineers to model the application domain with the abstraction mechanisms of generalization/specialization, association and aggregation. The tool generates a structure that implements persistent database-objects through the automatic generation of customized SQL ANSI scripts that sustain the semantics defined in the higher lever. This paper emphasizes the system architecture and the mapping of the semantic model into relational tables. The present status of the project and its further developments are discussed in the Conclusions. PMID:8563288

  20. National Ambient Radiation Database

    SciTech Connect

    Dziuban, J.; Sears, R.

    2003-02-25

    The U.S. Environmental Protection Agency (EPA) recently developed a searchable database and website for the Environmental Radiation Ambient Monitoring System (ERAMS) data. This site contains nationwide radiation monitoring data for air particulates, precipitation, drinking water, surface water and pasteurized milk. This site provides location-specific as well as national information on environmental radioactivity across several media. It provides high quality data for assessing public exposure and environmental impacts resulting from nuclear emergencies and provides baseline data during routine conditions. The database and website are accessible at www.epa.gov/enviro/. This site contains (1) a query for the general public which is easy to use--limits the amount of information provided, but includes the ability to graph the data with risk benchmarks and (2) a query for a more technical user which allows access to all of the data in the database, (3) background information on ER AMS.

  1. Gastrointestinal illnesses among French forces deployed to Djibouti: French military health surveillance, 2005-2009.

    PubMed

    Ollivier, Lénaïck; Decam, Christophe; Pommier de Santi, Vincent; Darar, Houssein Y; Dia, Aïssata; Nevin, Remington L; Romand, Olivier; Bougère, Jacques; Deparis, Xavier; Boutin, Jean-Paul

    2010-10-01

    Despite an increase in foreign tourism and in the numbers of foreign military personnel deployed to Djibouti, little is known about the risk of gastrointestinal illness in this country in eastern Africa. To assess risk and to describe common features of gastrointestinal illnesses, reports of illness derived from military health surveillance data collected during 2005-2009 among French service members deployed to Djibouti were reviewed. Diarrhea was the most common problem; it had an annual incidence ranging from 260 to 349 cases per 1,000 person-years. The risk was higher among soldiers deployed short-term (four months) than among soldiers deployed long-term (two years). This five-year review of French health surveillance data documents a significant burden of diarrhea among French soldiers in Djibouti. The identification of factors associated with risk may permit efficient targeting of interventions to reduce morbidity from gastrointestinal illness.

  2. The Neotoma Paleoecology Database

    NASA Astrophysics Data System (ADS)

    Grimm, E. C.; Ashworth, A. C.; Barnosky, A. D.; Betancourt, J. L.; Bills, B.; Booth, R.; Blois, J.; Charles, D. F.; Graham, R. W.; Goring, S. J.; Hausmann, S.; Smith, A. J.; Williams, J. W.; Buckland, P.

    2015-12-01

    The Neotoma Paleoecology Database (www.neotomadb.org) is a multiproxy, open-access, relational database that includes fossil data for the past 5 million years (the late Neogene and Quaternary Periods). Modern distributional data for various organisms are also being made available for calibration and paleoecological analyses. The project is a collaborative effort among individuals from more than 20 institutions worldwide, including domain scientists representing a spectrum of Pliocene-Quaternary fossil data types, as well as experts in information technology. Working groups are active for diatoms, insects, ostracodes, pollen and plant macroscopic remains, testate amoebae, rodent middens, vertebrates, age models, geochemistry and taphonomy. Groups are also active in developing online tools for data analyses and for developing modules for teaching at different levels. A key design concept of NeotomaDB is that stewards for various data types are able to remotely upload and manage data. Cooperatives for different kinds of paleo data, or from different regions, can appoint their own stewards. Over the past year, much progress has been made on development of the steward software-interface that will enable this capability. The steward interface uses web services that provide access to the database. More generally, these web services enable remote programmatic access to the database, which both desktop and web applications can use and which provide real-time access to the most current data. Use of these services can alleviate the need to download the entire database, which can be out-of-date as soon as new data are entered. In general, the Neotoma web services deliver data either from an entire table or from the results of a view. Upon request, new web services can be quickly generated. Future developments will likely expand the spatial and temporal dimensions of the database. NeotomaDB is open to receiving new datasets and stewards from the global Quaternary community

  3. Database Management System

    NASA Technical Reports Server (NTRS)

    1990-01-01

    In 1981 Wayne Erickson founded Microrim, Inc, a company originally focused on marketing a microcomputer version of RIM (Relational Information Manager). Dennis Comfort joined the firm and is now vice president, development. The team developed an advanced spinoff from the NASA system they had originally created, a microcomputer database management system known as R:BASE 4000. Microrim added many enhancements and developed a series of R:BASE products for various environments. R:BASE is now the second largest selling line of microcomputer database management software in the world.

  4. JICST Factual Database(1)

    NASA Astrophysics Data System (ADS)

    Kurosawa, Shinji

    The outline of JICST factual database (JOIS-F), which JICST has started from January, 1988, and its online service are described in this paper. First, the author mentions the circumstances from 1973, when its planning was started, to the present, and its relation to "Project by Special Coordination Founds for Promoting Science and Technology". Secondly, databases, which are now under development aiming to start its services from fiscal 1988 or fiscal 1989, of DNA, metallic material intensity, crystal structure, chemical substance regulations, and so forth, are described. Lastly, its online service is briefly explained.

  5. Drycleaner Database - Region 7

    EPA Pesticide Factsheets

    THIS DATA ASSET NO LONGER ACTIVE: This is metadata documentation for the Region 7 Drycleaner Database (R7DryClnDB) which tracks all Region7 drycleaners who notify Region 7 subject to Maximum Achievable Control Technologiy (MACT) standards. The Air and Waste Management Division is the primary managing entity for this database. This work falls under objectives for EPA's 2003-2008 Strategic Plan (Goal 4) for Healthy Communities & Ecosystems, which are to reduce chemical and/or pesticide risks at facilities.

  6. The Genopolis Microarray Database

    PubMed Central

    Splendiani, Andrea; Brandizi, Marco; Even, Gael; Beretta, Ottavio; Pavelka, Norman; Pelizzola, Mattia; Mayhaus, Manuel; Foti, Maria; Mauri, Giancarlo; Ricciardi-Castagnoli, Paola

    2007-01-01

    Background Gene expression databases are key resources for microarray data management and analysis and the importance of a proper annotation of their content is well understood. Public repositories as well as microarray database systems that can be implemented by single laboratories exist. However, there is not yet a tool that can easily support a collaborative environment where different users with different rights of access to data can interact to define a common highly coherent content. The scope of the Genopolis database is to provide a resource that allows different groups performing microarray experiments related to a common subject to create a common coherent knowledge base and to analyse it. The Genopolis database has been implemented as a dedicated system for the scientific community studying dendritic and macrophage cells functions and host-parasite interactions. Results The Genopolis Database system allows the community to build an object based MIAME compliant annotation of their experiments and to store images, raw and processed data from the Affymetrix GeneChip® platform. It supports dynamical definition of controlled vocabularies and provides automated and supervised steps to control the coherence of data and annotations. It allows a precise control of the visibility of the database content to different sub groups in the community and facilitates exports of its content to public repositories. It provides an interactive users interface for data analysis: this allows users to visualize data matrices based on functional lists and sample characterization, and to navigate to other data matrices defined by similarity of expression values as well as functional characterizations of genes involved. A collaborative environment is also provided for the definition and sharing of functional annotation by users. Conclusion The Genopolis Database supports a community in building a common coherent knowledge base and analyse it. This fills a gap between a local

  7. Databases for plant phosphoproteomics.

    PubMed

    Schulze, Waltraud X; Yao, Qiuming; Xu, Dong

    2015-01-01

    Phosphorylation is the most studied posttranslational modification involved in signal transduction in stress responses, development, and growth. In the recent years large-scale phosphoproteomic studies were carried out using various model plants and several growth and stress conditions. Here we present an overview of online resources for plant phosphoproteomic databases: PhosPhAt as a resource for Arabidopsis phosphoproteins, P3DB as a resource expanding to crop plants, and Medicago PhosphoProtein Database as a resource for the model plant Medicago trunculata.

  8. Language barriers and bibliographic retrieval effectiveness: use of MEDLINE by French-speaking end users.

    PubMed Central

    Mouillet, E

    1999-01-01

    OBJECTIVE: A study was conducted to determine if bibliographic retrieval performed by French-speaking end users is impaired by English language interfaces. The American database MEDLINE on CD-ROM was used as a model. METHODS: A survey of self-administered questionnaires was performed at two libraries of Victor Segalen Bordeaux 2 University, during a two-month period in 1997. Three study groups were constituted: MEDLINE / Ovid end users, MEDLINE / Ovid librarian-mediated users, and Pascal, a French bibliographic database, end users. RESULTS: Among 191 respondents, only 22% thought English was an obstacle to their bibliographic retrieval. However, the research software was generally underused and the quality of the retrieval weak. The differences were statistically significant between users trained by librarians and the self-trained group, the former performing better. CONCLUSION: Special efforts need to be made to develop curriculum training programs for computerized bibliographic retrieval in medical schools, regardless of the native language of the student. PMID:10550030

  9. The "Bain Linguistique": A Core French Experiment at Churchill Alternative School, 1993-94. Final Report.

    ERIC Educational Resources Information Center

    Wesche, Marjorie; MacFarlane, Alina; Peters, Martine

    This report describes an experimental intensive core French program for grades 5 and 6 at Churchill Alternative School in Ottawa (Canada). The aim was to improve the oral French skills of core French students by providing a period of intensive exposure to French and by increasing the total number of hours in French during one program year from 120…

  10. Weathering Database Technology

    ERIC Educational Resources Information Center

    Snyder, Robert

    2005-01-01

    Collecting weather data is a traditional part of a meteorology unit at the middle level. However, making connections between the data and weather conditions can be a challenge. One way to make these connections clearer is to enter the data into a database. This allows students to quickly compare different fields of data and recognize which…

  11. Danish Gynecological Cancer Database

    PubMed Central

    Sørensen, Sarah Mejer; Bjørn, Signe Frahm; Jochumsen, Kirsten Marie; Jensen, Pernille Tine; Thranov, Ingrid Regitze; Hare-Bruun, Helle; Seibæk, Lene; Høgdall, Claus

    2016-01-01

    Aim of database The Danish Gynecological Cancer Database (DGCD) is a nationwide clinical cancer database and its aim is to monitor the treatment quality of Danish gynecological cancer patients, and to generate data for scientific purposes. DGCD also records detailed data on the diagnostic measures for gynecological cancer. Study population DGCD was initiated January 1, 2005, and includes all patients treated at Danish hospitals for cancer of the ovaries, peritoneum, fallopian tubes, cervix, vulva, vagina, and uterus, including rare histological types. Main variables DGCD data are organized within separate data forms as follows: clinical data, surgery, pathology, pre- and postoperative care, complications, follow-up visits, and final quality check. DGCD is linked with additional data from the Danish “Pathology Registry”, the “National Patient Registry”, and the “Cause of Death Registry” using the unique Danish personal identification number (CPR number). Descriptive data Data from DGCD and registers are available online in the Statistical Analysis Software portal. The DGCD forms cover almost all possible clinical variables used to describe gynecological cancer courses. The only limitation is the registration of oncological treatment data, which is incomplete for a large number of patients. Conclusion The very complete collection of available data from more registries form one of the unique strengths of DGCD compared to many other clinical databases, and provides unique possibilities for validation and completeness of data. The success of the DGCD is illustrated through annual reports, high coverage, and several peer-reviewed DGCD-based publications. PMID:27822089

  12. Uranium Location Database

    EPA Pesticide Factsheets

    A GIS compiled locational database in Microsoft Access of ~15,000 mines with uranium occurrence or production, primarily in the western United States. The metadata was cooperatively compiled from Federal and State agency data sets and enables the user to conduct geographic and analytical studies on mine impacts on the public and environment.

  13. The Exoplanet Orbit Database

    NASA Astrophysics Data System (ADS)

    Wright, J. T.; Fakhouri, O.; Marcy, G. W.; Han, E.; Feng, Y.; Johnson, John Asher; Howard, A. W.; Fischer, D. A.; Valenti, J. A.; Anderson, J.; Piskunov, N.

    2011-04-01

    We present a database of well-determined orbital parameters of exoplanets, and their host stars’ properties. This database comprises spectroscopic orbital elements measured for 427 planets orbiting 363 stars from radial velocity and transit measurements as reported in the literature. We have also compiled fundamental transit parameters, stellar parameters, and the method used for the planets discovery. This Exoplanet Orbit Database includes all planets with robust, well measured orbital parameters reported in peer-reviewed articles. The database is available in a searchable, filterable, and sortable form online through the Exoplanets Data Explorer table, and the data can be plotted and explored through the Exoplanet Data Explorer plotter. We use the Data Explorer to generate publication-ready plots, giving three examples of the signatures of exoplanet migration and dynamical evolution: We illustrate the character of the apparent correlation between mass and period in exoplanet orbits, the different selection biases between radial velocity and transit surveys, and that the multiplanet systems show a distinct semimajor-axis distribution from apparently singleton systems.

  14. Patent Family Databases.

    ERIC Educational Resources Information Center

    Simmons, Edlyn S.

    1985-01-01

    Reports on retrieval of patent information online and includes definition of patent family, basic and equivalent patents, "parents and children" applications, designated states, patent family databases--International Patent Documentation Center, World Patents Index, APIPAT (American Petroleum Institute), CLAIMS (IFI/Plenum). A table…

  15. Diatomic Spectral Database

    National Institute of Standards and Technology Data Gateway

    SRD 114 Diatomic Spectral Database (Web, free access)   All of the rotational spectral lines observed and reported in the open literature for 121 diatomic molecules have been tabulated. The isotopic molecular species, assigned quantum numbers, observed frequency, estimated measurement uncertainty, and reference are given for each transition reported.

  16. High Performance Buildings Database

    DOE Data Explorer

    The High Performance Buildings Database is a shared resource for the building industry, a unique central repository of in-depth information and data on high-performance, green building projects across the United States and abroad. The database includes information on the energy use, environmental performance, design process, finances, and other aspects of each project. Members of the design and construction teams are listed, as are sources for additional information. In total, up to twelve screens of detailed information are provided for each project profile. Projects range in size from small single-family homes or tenant fit-outs within buildings to large commercial and institutional buildings and even entire campuses. The database is a data repository as well. A series of Web-based data-entry templates allows anyone to enter information about a building project into the database. Once a project has been submitted, each of the partner organizations can review the entry and choose whether or not to publish that particular project on its own Web site.

  17. MARC and Relational Databases.

    ERIC Educational Resources Information Center

    Llorens, Jose; Trenor, Asuncion

    1993-01-01

    Discusses the use of MARC format in relational databases and addresses problems of incompatibilities. A solution is presented that is in accordance with Open Systems Interconnection (OSI) standards and is based on experiences at the library of the Universidad Politecnica de Valencia (Spain). (four references) (EA)

  18. Databases and data mining

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Over the course of the past decade, the breadth of information that is made available through online resources for plant biology has increased astronomically, as have the interconnectedness among databases, online tools, and methods of data acquisition and analysis. For maize researchers, the numbe...

  19. Hydrocarbon Spectral Database

    National Institute of Standards and Technology Data Gateway

    SRD 115 Hydrocarbon Spectral Database (Web, free access)   All of the rotational spectral lines observed and reported in the open literature for 91 hydrocarbon molecules have been tabulated. The isotopic molecular species, assigned quantum numbers, observed frequency, estimated measurement uncertainty and reference are given for each transition reported.

  20. Danish Urogynaecological Database

    PubMed Central

    Hansen, Ulla Darling; Gradel, Kim Oren; Larsen, Michael Due

    2016-01-01

    The Danish Urogynaecological Database is established in order to ensure high quality of treatment for patients undergoing urogynecological surgery. The database contains details of all women in Denmark undergoing incontinence surgery or pelvic organ prolapse surgery amounting to ~5,200 procedures per year. The variables are collected along the course of treatment of the patient from the referral to a postoperative control. Main variables are prior obstetrical and gynecological history, symptoms, symptom-related quality of life, objective urogynecological findings, type of operation, complications if relevant, implants used if relevant, 3–6-month postoperative recording of symptoms, if any. A set of clinical quality indicators is being maintained by the steering committee for the database and is published in an annual report which also contains extensive descriptive statistics. The database has a completeness of over 90% of all urogynecological surgeries performed in Denmark. Some of the main variables have been validated using medical records as gold standard. The positive predictive value was above 90%. The data are used as a quality monitoring tool by the hospitals and in a number of scientific studies of specific urogynecological topics, broader epidemiological topics, and the use of patient reported outcome measures. PMID:27826217

  1. Food composition databases

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Food composition is the determination of what is in the foods we eat and is the critical bridge between nutrition, health promotion and disease prevention and food production. Compilation of data into useable databases is essential to the development of dietary guidance for individuals and populat...

  2. Redis database administration tool

    SciTech Connect

    Martinez, J. J.

    2013-02-13

    MyRedis is a product of the Lorenz subproject under the ASC Scirntific Data Management effort. MyRedis is a web based utility designed to allow easy administration of instances of Redis databases. It can be usedd to view and manipulate data as well as run commands directly against a variety of different Redis hosts.

  3. The CEBAF Element Database

    SciTech Connect

    Theodore Larrieu, Christopher Slominski, Michele Joyce

    2011-03-01

    With the inauguration of the CEBAF Element Database (CED) in Fall 2010, Jefferson Lab computer scientists have taken a step toward the eventual goal of a model-driven accelerator. Once fully populated, the database will be the primary repository of information used for everything from generating lattice decks to booting control computers to building controls screens. A requirement influencing the CED design is that it provide access to not only present, but also future and past configurations of the accelerator. To accomplish this, an introspective database schema was designed that allows new elements, types, and properties to be defined on-the-fly with no changes to table structure. Used in conjunction with Oracle Workspace Manager, it allows users to query data from any time in the database history with the same tools used to query the present configuration. Users can also check-out workspaces to use as staging areas for upcoming machine configurations. All Access to the CED is through a well-documented Application Programming Interface (API) that is translated automatically from original C++ source code into native libraries for scripting languages such as perl, php, and TCL making access to the CED easy and ubiquitous.

  4. Triatomic Spectral Database

    National Institute of Standards and Technology Data Gateway

    SRD 117 Triatomic Spectral Database (Web, free access)   All of the rotational spectral lines observed and reported in the open literature for 55 triatomic molecules have been tabulated. The isotopic molecular species, assigned quantum numbers, observed frequency, estimated measurement uncertainty and reference are given for each transition reported.

  5. JDD, Inc. Database

    NASA Technical Reports Server (NTRS)

    Miller, David A., Jr.

    2004-01-01

    JDD Inc, is a maintenance and custodial contracting company whose mission is to provide their clients in the private and government sectors "quality construction, construction management and cleaning services in the most efficient and cost effective manners, (JDD, Inc. Mission Statement)." This company provides facilities support for Fort Riley in Fo,rt Riley, Kansas and the NASA John H. Glenn Research Center at Lewis Field here in Cleveland, Ohio. JDD, Inc. is owned and operated by James Vaughn, who started as painter at NASA Glenn and has been working here for the past seventeen years. This summer I worked under Devan Anderson, who is the safety manager for JDD Inc. in the Logistics and Technical Information Division at Glenn Research Center The LTID provides all transportation, secretarial, security needs and contract management of these various services for the center. As a safety manager, my mentor provides Occupational Health and Safety Occupation (OSHA) compliance to all JDD, Inc. employees and handles all other issues (Environmental Protection Agency issues, workers compensation, safety and health training) involving to job safety. My summer assignment was not as considered "groundbreaking research" like many other summer interns have done in the past, but it is just as important and beneficial to JDD, Inc. I initially created a database using a Microsoft Excel program to classify and categorize data pertaining to numerous safety training certification courses instructed by our safety manager during the course of the fiscal year. This early portion of the database consisted of only data (training field index, employees who were present at these training courses and who was absent) from the training certification courses. Once I completed this phase of the database, I decided to expand the database and add as many dimensions to it as possible. Throughout the last seven weeks, I have been compiling more data from day to day operations and been adding the

  6. Sleeping porch through french doors off master bedroom (southern unit) ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    Sleeping porch through french doors off master bedroom (southern unit) - Fitzsimons General Hospital, Officers' Quarters, West Charlie Kelly Boulevard & South Hutton Street, Southwest Corner, Aurora, Adams County, CO

  7. Tautomerism in large databases

    PubMed Central

    Sitzmann, Markus; Ihlenfeldt, Wolf-Dietrich

    2010-01-01

    We have used the Chemical Structure DataBase (CSDB) of the NCI CADD Group, an aggregated collection of over 150 small-molecule databases totaling 103.5 million structure records, to conduct tautomerism analyses on one of the largest currently existing sets of real (i.e. not computer-generated) compounds. This analysis was carried out using calculable chemical structure identifiers developed by the NCI CADD Group, based on hash codes available in the chemoinformatics toolkit CACTVS and a newly developed scoring scheme to define a canonical tautomer for any encountered structure. CACTVS’s tautomerism definition, a set of 21 transform rules expressed in SMIRKS line notation, was used, which takes a comprehensive stance as to the possible types of tautomeric interconversion included. Tautomerism was found to be possible for more than 2/3 of the unique structures in the CSDB. A total of 680 million tautomers were calculated from, and including, the original structure records. Tautomerism overlap within the same individual database (i.e. at least one other entry was present that was really only a different tautomeric representation of the same compound) was found at an average rate of 0.3% of the original structure records, with values as high as nearly 2% for some of the databases in CSDB. Projected onto the set of unique structures (by FICuS identifier), this still occurred in about 1.5% of the cases. Tautomeric overlap across all constituent databases in CSDB was found for nearly 10% of the records in the collection. PMID:20512400

  8. The French Space Operations Act: Technical Regulations

    NASA Astrophysics Data System (ADS)

    Lazare, B.

    2013-12-01

    The French Space Operations Act (FSOA) [1] stipulates that one of the National Technical Regulations' prime objectives is to protect people, property, public health and the environment. Compliance with these Technical Regulations has been mandatory since 10 December, 2010 for space operations by French space operators and for space operations conducted on French territory. The space safety requirements and regulations governing procedures are based on national and international best practices and experience. A critical design review of the space system and procedures shall be carried out by applicant space operators, in order to verify compliance with the Technical Regulations. An independent technical assessment of the operation is delegated to CNES. The principles applied when drafting the Technical Regulations are as follows: requirements must, as far as possible, establish the rules according to the objective to be obtained, rather than how it is to be achieved; requirements must give preference to international standards recognised as being state of the art; requirements must take previous experience into account. The Technical Regulations are divided into three sections covering requirements common to the launch, control and return of a space object. A special section will cover specific rules to be applied at the Guiana Space Centre. The main topics addressed by the Technical Regulations are: operator safety management system; study of risks to people, property, public health and the Earth's environment; impact study on the outer space environment: space debris generated by the operation; planetary protection. The first version of the Technical Regulations [2], issued in March 2011, is dedicated to unmanned space systems.

  9. Snow management practices in French ski resorts

    NASA Astrophysics Data System (ADS)

    Spandre, Pierre; Francois, Hugues; George-Marcelpoil, Emmanuelle; Morin, Samuel

    2016-04-01

    Winter tourism plays a fundamental role in the economy of French mountain regions but also in other countries such as Austria, USA or Canada. Ski operators originally developed grooming methods to provide comfortable and safe skiing conditions. The interannual variability of snow conditions and the competition with international destinations and alternative tourism activities encouraged ski resorts to mitigate their dependency to weather conditions through snowmaking facilities. However some regions may not be able to produce machine made snow due to inadequate conditions and low altitude resorts are still negatively impacted by low snow seasons. In the meantime, even though the operations of high altitude resorts do not show any dependency to the snow conditions they invest in snowmaking facilities. Such developments of snowmaking facilities may be related to a confused and contradictory perception of climate change resulting in individualistic evolutions of snowmaking facilities, also depending on ski resorts main features such as their altitude and size. Concurrently with the expansion of snowmaking facilities, a large range of indicators have been used to discuss the vulnerability of ski resorts such as the so-called "100 days rule" which was widely used with specific thresholds (i.e. minimum snow depth, dates) and constraints (i.e. snowmaking capacity). The present study aims to provide a detailed description of snow management practices and major priorities in French ski resorts with respect to their characteristics. We set up a survey in autumn 2014, collecting data from 56 French ski operators. We identify the priorities of ski operators and describe their snowmaking and grooming practices and facilities. The operators also provided their perception of the ski resort vulnerability to snow and economic challenges which we could compare with the actual snow conditions and ski lift tickets sales during the period from 2001 to 2012.

  10. JICST Factual DatabaseJICST Chemical Substance Safety Regulation Database

    NASA Astrophysics Data System (ADS)

    Abe, Atsushi; Sohma, Tohru

    JICST Chemical Substance Safety Regulation Database is based on the Database of Safety Laws for Chemical Compounds constructed by Japan Chemical Industry Ecology-Toxicology & Information Center (JETOC) sponsored by the Sience and Technology Agency in 1987. JICST has modified JETOC database system, added data and started the online service through JOlS-F (JICST Online Information Service-Factual database) in January 1990. JICST database comprises eighty-three laws and fourteen hundred compounds. The authors outline the database, data items, files and search commands. An example of online session is presented.

  11. Too Much French? Not Enough French?: The Vancouver Olympics and a Very Canadian Language Ideological Debate

    ERIC Educational Resources Information Center

    Vessey, Rachelle

    2013-01-01

    This paper discusses a language ideological debate that took place in Canadian national newspapers following the opening ceremonies for the 2011 Vancouver Olympics. Reports on the insufficient use of French during the opening ceremonies sparked protest from politicians, official commentators, citizens and online newsreaders alike. Previous…

  12. Cigeo, the French Geological Repository Project - 13022

    SciTech Connect

    Labalette, Thibaud; Harman, Alain; Dupuis, Marie-Claude; Ouzounian, Gerald

    2013-07-01

    The Cigeo industrial-scale geological disposal centre is designed for the disposal of the most highly-radioactive French waste. It will be built in an argillite formation of the Callovo-Oxfordian dating back 160 million years. The Cigeo project is located near the Bure village in the Paris Basin. The argillite formation was studied since 1974, and from the Meuse/Haute-Marne underground research laboratory since end of 1999. Most of the waste to be disposed of in the Cigeo repository comes from nuclear power plants and from reprocessing of their spent fuel. (authors)

  13. Norovirus contamination on French marketed oysters.

    PubMed

    Schaeffer, Julien; Le Saux, Jean-Claude; Lora, Monica; Atmar, Robert L; Le Guyader, Françoise S

    2013-09-02

    Contaminated shellfish have been implicated in gastroenteritis outbreaks in different countries. As no regulation has been set up yet regarding viral contamination of food, very few data are available on the prevalence of contaminated products on the market. This study presents data obtained from oysters collected on the French market in one producing area over a 16 month period of time. Noroviruses were detected in 9% of samples with a seasonal impact and influence of climatic events. Contamination levels were low and, surprisingly, oysters sampled directly from the producer were found to have less contamination than oysters from supermarkets.

  14. [Composite editorial contents in French chemical journals].

    PubMed

    Dalbin, Sylvie

    2014-01-01

    This study of a corpus of French chemistry journals between 1800 and 2010 shows the relevance of the journal as the primary mode of communication, confirming the results of the general survey presented in this issue. However, a study of their contents is questioning the apparent unity of this phenomenon: the journal appears as a physical medium consisting in a common container including a wide range of information categories transferred over time to digital platforms in development since the end of the 20(th) century.

  15. Norovirus contamination on French marketed oysters

    PubMed Central

    Schaeffer, Julien; Le Saux, Jean-Claude; Lora, Monica; Atmar, Robert L.; Le Guyader, Françoise S.

    2014-01-01

    Contaminated shellfish have been implicated in gastroenteritis outbreaks in different countries. As no regulation has been set up yet regarding viral contamination of food, very few data are available on the prevalence of contaminated products on the market. This study presents data obtained from oysters collected on the French market in one producing area over a 16 month period of time. Noroviruses were detected in 9% of samples with a seasonal impact and influence of climatic events. Contamination levels were low and, surprisingly, oysters sampled directly from the producer were found to have less contamination than oysters from supermarkets. PMID:23973835

  16. Darwin: German mystic or French rationalist?

    PubMed

    Ghiselin, Michael T

    2015-01-01

    The notion that Charles Darwin embraced the German Romantic tradition seems plausible, given the early influence of Alexander von Humboldt. But this view fails to do justice to other scientific traditions. Darwin was a protégé of the Englishman John Stevens Henslow and was a follower of the Scott Charles Lyell. He had important debts to French scientists, notably Henri Milne-Edwards, Etienne and Isidore Geoffroy Saint-Hilaire, and Alphonse de Candolle. Many Germans were quite supportive of Darwin, but not all of these were encumbered by idealistic metaphysical baggage. Both Darwin and Anton Dohrn treated science as very much a cosmopolitan enterprise.

  17. Une Planche de Salut pour le Francais: le Francais Quotidien et les Niveaux de Langue (A Last Resort for French: Everyday French and Language Levels)

    ERIC Educational Resources Information Center

    Jonas, Maurice

    1977-01-01

    Before asking how to teach French, one should ask what French to teach. It is suggested that everyday French, "la langue usuelle," should be the norm for American teachers and textbook writers and editers. Greater utilization of film scenarios and songs of good quality are among the means suggested. (Text is in French.) (AMH)

  18. Protein Model Database

    SciTech Connect

    Fidelis, K; Adzhubej, A; Kryshtafovych, A; Daniluk, P

    2005-02-23

    The phenomenal success of the genome sequencing projects reveals the power of completeness in revolutionizing biological science. Currently it is possible to sequence entire organisms at a time, allowing for a systemic rather than fractional view of their organization and the various genome-encoded functions. There is an international plan to move towards a similar goal in the area of protein structure. This will not be achieved by experiment alone, but rather by a combination of efforts in crystallography, NMR spectroscopy, and computational modeling. Only a small fraction of structures are expected to be identified experimentally, the remainder to be modeled. Presently there is no organized infrastructure to critically evaluate and present these data to the biological community. The goal of the Protein Model Database project is to create such infrastructure, including (1) public database of theoretically derived protein structures; (2) reliable annotation of protein model quality, (3) novel structure analysis tools, and (4) access to the highest quality modeling techniques available.

  19. ARTI Refrigerant Database

    SciTech Connect

    Calm, J.M.

    1992-11-09

    The database provides bibliographic citations and abstracts for publications that may be useful in research and design of air- conditioning and refrigeration equipment. The database identifies sources of specific information on R-32, R-123, R-124, R-125, R-134, R-134a, R-141b, R-142b, R-143a, R-152a, R-245ca, R-290 (propane), R- 717 (ammonia), ethers, and others as well as azeotropic and zeotropic and zeotropic blends of these fluids. It addresses lubricants including alkylbenzene, polyalkylene glycol, ester, and other synthetics as well as mineral oils. It also references documents on compatibility of refrigerants and lubricants with metals, plastics, elastomers, motor insulation, and other materials used in refrigerant circuits. A computerized version is available that includes retrieval software.

  20. 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

    PubMed Central

    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 study of self-reported gestational exposures and pregnancy outcomes. Methods 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. Results 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 (P<.001). However, we identified international variations in both the cost-effectiveness of the various advertisement methods used and in their ability to recruit participants in early pregnancy. Conclusions Recruitment of a

  1. Surgical research using national databases.

    PubMed

    Alluri, Ram K; Leland, Hyuma; Heckmann, Nathanael

    2016-10-01

    Recent changes in healthcare and advances in technology have increased the use of large-volume national databases in surgical research. These databases have been used to develop perioperative risk stratification tools, assess postoperative complications, calculate costs, and investigate numerous other topics across multiple surgical specialties. The results of these studies contain variable information but are subject to unique limitations. The use of large-volume national databases is increasing in popularity, and thorough understanding of these databases will allow for a more sophisticated and better educated interpretation of studies that utilize such databases. This review will highlight the composition, strengths, and weaknesses of commonly used national databases in surgical research.

  2. Surgical research using national databases

    PubMed Central

    Leland, Hyuma; Heckmann, Nathanael

    2016-01-01

    Recent changes in healthcare and advances in technology have increased the use of large-volume national databases in surgical research. These databases have been used to develop perioperative risk stratification tools, assess postoperative complications, calculate costs, and investigate numerous other topics across multiple surgical specialties. The results of these studies contain variable information but are subject to unique limitations. The use of large-volume national databases is increasing in popularity, and thorough understanding of these databases will allow for a more sophisticated and better educated interpretation of studies that utilize such databases. This review will highlight the composition, strengths, and weaknesses of commonly used national databases in surgical research. PMID:27867945

  3. ARTI refrigerant database

    SciTech Connect

    Calm, J.M.

    1996-07-01

    The Refrigerant Database is an information system on alternative refrigerants, associated lubricants, and their use in air conditioning and refrigeration. It consolidates and facilitates access to property, compatibility, environmental, safety, application and other information. It provides corresponding information on older refrigerants, to assist manufacturers and those using alternative refrigerants, to make comparisons and determine differences. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern.

  4. ARTI refrigerant database

    SciTech Connect

    Calm, J.M.

    1999-01-01

    The Refrigerant Database is an information system on alternative refrigerants, associated lubricants, and their use in air conditioning and refrigeration. It consolidates and facilities access to property, compatibility, environmental, safety, application and other information. It provides corresponding information on older refrigerants, to assist manufacturers and those using alternative refrigerants, to make comparisons and determine differences. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern.

  5. COBE Astronomical Databases

    NASA Astrophysics Data System (ADS)

    Freedman, I.; Raugh, A. C.; Cheng, E. S.

    A project to store and convert external astronomical survey maps to the Cosmic Background Explorer (COBE) spacecraft pixelization is described. Established software is reused in order to reduce development costs. The proposed packages and systems include the Image Reduction and Analysis Facility (IRAF), Interactive Data Language Astronomy Library (IDL), the FITSIO data transfer package and the Astronomical Image Processing System (AIPS). The software structure of the astronomical databases, projected conversion schemes, quality assurance procedures and outstanding problems will be discussed.

  6. Developing customer databases.

    PubMed

    Rao, S K; Shenbaga, S

    2000-01-01

    There is a growing consensus among pharmaceutical companies that more product and customer-specific approaches to marketing and selling a new drug can result in substantial increases in sales. Marketers and researchers taking a proactive micro-marketing approach to identifying, profiling, and communicating with target customers are likely to facilitate such approaches and outcomes. This article provides a working framework for creating customer databases that can be effectively mined to achieve a variety of such marketing and sales force objectives.

  7. ARTI refrigerant database

    SciTech Connect

    Calm, J.M.

    1996-11-15

    The Refrigerant Database is an information system on alternative refrigerants, associated lubricants, and their use in air conditioning and refrigeration. It consolidates and facilitates access to property, compatibility, environmental, safety, application and other information. It provides corresponding information on older refrigerants, to assist manufacturers and those using alternative refrigerants, to make comparisons and determine differences. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern.

  8. The Danish Melanoma Database

    PubMed Central

    Hölmich, Lisbet Rosenkrantz; Klausen, Siri; Spaun, Eva; Schmidt, Grethe; Gad, Dorte; Svane, Inge Marie; Schmidt, Henrik; Lorentzen, Henrik Frank; Ibfelt, Else Helene

    2016-01-01

    Aim of database The aim of the database is to monitor and improve the treatment and survival of melanoma patients. Study population All Danish patients with cutaneous melanoma and in situ melanomas must be registered in the Danish Melanoma Database (DMD). In 2014, 2,525 patients with invasive melanoma and 780 with in situ tumors were registered. The coverage is currently 93% compared with the Danish Pathology Register. Main variables The main variables include demographic, clinical, and pathological characteristics, including Breslow’s tumor thickness, ± ulceration, mitoses, and tumor–node–metastasis stage. Information about the date of diagnosis, treatment, type of surgery, including safety margins, results of lymphoscintigraphy in patients for whom this was indicated (tumors > T1a), results of sentinel node biopsy, pathological evaluation hereof, and follow-up information, including recurrence, nature, and treatment hereof is registered. In case of death, the cause and date are included. Currently, all data are entered manually; however, data catchment from the existing registries is planned to be included shortly. Descriptive data The DMD is an old research database, but new as a clinical quality register. The coverage is high, and the performance in the five Danish regions is quite similar due to strong adherence to guidelines provided by the Danish Melanoma Group. The list of monitored indicators is constantly expanding, and annual quality reports are issued. Several important scientific studies are based on DMD data. Conclusion DMD holds unique detailed information about tumor characteristics, the surgical treatment, and follow-up of Danish melanoma patients. Registration and monitoring is currently expanding to encompass even more clinical parameters to benefit both patient treatment and research. PMID:27822097

  9. Electronic Journals as Databases

    NASA Astrophysics Data System (ADS)

    Holl, A.

    2004-07-01

    The Information Bulletin on Variable Stars is a bulletin fully available in electronic form. We are working on converting the text, tables and figures of the papers published into a database, and, at the same time, making them accessible and addressable. IBVS Data Service will provide information on variable stars --- like finding charts, light curves --- and will be VO compatible. Other services could link to individual figures, data files, etc. this way.

  10. Real Time Baseball Database

    NASA Astrophysics Data System (ADS)

    Fukue, Yasuhiro

    The author describes the system outline, features and operations of "Nikkan Sports Realtime Basaball Database" which was developed and operated by Nikkan Sports Shimbun, K. K. The system enables to input numerical data of professional baseball games as they proceed simultaneously, and execute data updating at realtime, just-in-time. Other than serving as supporting tool for prepareing newspapers it is also available for broadcasting media, general users through NTT dial Q2 and others.

  11. The Danish Sarcoma Database

    PubMed Central

    Jørgensen, Peter Holmberg; Lausten, Gunnar Schwarz; Pedersen, Alma B

    2016-01-01

    Aim The aim of the database is to gather information about sarcomas treated in Denmark in order to continuously monitor and improve the quality of sarcoma treatment in a local, a national, and an international perspective. Study population Patients in Denmark diagnosed with a sarcoma, both skeletal and ekstraskeletal, are to be registered since 2009. Main variables The database contains information about appearance of symptoms; date of receiving referral to a sarcoma center; date of first visit; whether surgery has been performed elsewhere before referral, diagnosis, and treatment; tumor characteristics such as location, size, malignancy grade, and growth pattern; details on treatment (kind of surgery, amount of radiation therapy, type and duration of chemotherapy); complications of treatment; local recurrence and metastases; and comorbidity. In addition, several quality indicators are registered in order to measure the quality of care provided by the hospitals and make comparisons between hospitals and with international standards. Descriptive data Demographic patient-specific data such as age, sex, region of living, comorbidity, World Health Organization’s International Classification of Diseases – tenth edition codes and TNM Classification of Malignant Tumours, and date of death (after yearly coupling to the Danish Civil Registration System). Data quality and completeness are currently secured. Conclusion The Danish Sarcoma Database is population based and includes sarcomas occurring in Denmark since 2009. It is a valuable tool for monitoring sarcoma incidence and quality of treatment and its improvement, postoperative complications, and recurrence within 5 years follow-up. The database is also a valuable research tool to study the impact of technical and medical interventions on prognosis of sarcoma patients. PMID:27822116

  12. Unified Database Development Program.

    DTIC Science & Technology

    1984-03-01

    unified database (UDB) program was to develop an automated system that would be useful to those responsible for the design , development, testing, and...weapon system design . Baekgound The Air Force is concerned with the lack of adequate logistics consideration during the weapon system design process. To...produce a weapon system with optimal cost and mission effectiveness, logistics factors must be considered very early and throughout the system design

  13. ARTI refrigerant database

    SciTech Connect

    Calm, J.M.

    1997-02-01

    The Refrigerant Database is an information system on alternative refrigerants, associated lubricants, and their use in air conditioning and refrigeration. It consolidates and facilitates access to property, compatibility, environmental, safety, application and other information. It provides corresponding information on older refrigerants, to assist manufacturers and those using alterative refrigerants, to make comparisons and determine differences. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern. The database provides bibliographic citations and abstracts for publications that may be useful in research and design of air-conditioning and refrigeration equipment. The complete documents are not included, though some may be added at a later date. The database identifies sources of specific information on various refrigerants. It addresses lubricants including alkylbenzene, polyalkylene glycol, polyolester, and other synthetics as well as mineral oils. It also references documents addressing compatibility of refrigerants and lubricants with metals, plastics, elastomers, motor insulation, and other materials used in refrigerant circuits. Incomplete citations or abstracts are provided for some documents. They are included to accelerate availability of the information and will be completed or replaced in future updates.

  14. ARTI refrigerant database

    SciTech Connect

    Calm, J.M.

    1998-08-01

    The Refrigerant Database is an information system on alternative refrigerants, associated lubricants, and their use in air conditioning and refrigeration. It consolidates and facilitates access to property, compatibility, environmental, safety, application and other information. It provides corresponding information on older refrigerants, to assist manufactures and those using alternative refrigerants, to make comparisons and determine differences. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern. The database provides bibliographic citations and abstracts for publications that may be useful in research and design of air-conditioning and refrigeration equipment. The complete documents are not included, though some may be added at a later date. The database identifies sources of specific information on many refrigerants including propane, ammonia, water, carbon dioxide, propylene, ethers, and others as well as azeotropic and zeotropic blends of these fluids. It addresses lubricants including alkylbenzene, polyalkylene glycol, polyolester, and other synthetics as well as mineral oils. It also references documents addressing compatibility of refrigerants and lubricants with metals, plastics, elastomers, motor insulation, and other materials used in refrigerant circuits. Incomplete citations or abstracts are provided for some documents. They are included to accelerate availability of the information and will be completed or replaced in future updates.

  15. The Cambridge Structural Database.

    PubMed

    Groom, Colin R; Bruno, Ian J; Lightfoot, Matthew P; Ward, Suzanna C

    2016-04-01

    The Cambridge Structural Database (CSD) contains a complete record of all published organic and metal-organic small-molecule crystal structures. The database has been in operation for over 50 years and continues to be the primary means of sharing structural chemistry data and knowledge across disciplines. As well as structures that are made public to support scientific articles, it includes many structures published directly as CSD Communications. All structures are processed both computationally and by expert structural chemistry editors prior to entering the database. A key component of this processing is the reliable association of the chemical identity of the structure studied with the experimental data. This important step helps ensure that data is widely discoverable and readily reusable. Content is further enriched through selective inclusion of additional experimental data. Entries are available to anyone through free CSD community web services. Linking services developed and maintained by the CCDC, combined with the use of standard identifiers, facilitate discovery from other resources. Data can also be accessed through CCDC and third party software applications and through an application programming interface.

  16. ARTI Refrigerant Database

    SciTech Connect

    Cain, J.M.

    1993-04-30

    The Refrigerant Database consolidates and facilitates access to information to assist industry in developing equipment using alternative refrigerants. The underlying purpose is to accelerate phase out of chemical compounds of environmental concern. The database provides bibliographic citations and abstracts for publications that may be useful in research and design of air-conditioning and refrigeration equipment. The complete documents are not included. The database identifies sources of specific information on R-32, R-123, R-124, R-125, R-134, R-134a, R-141b, R-142b, R-143a, R-152a, R-245ca, R-290 (propane), R-717 (ammonia), ethers, and others as well as azeotropic and zeotropic blends of these fluids. It addresses lubricants including alkylbenzene, polyalkylene glycol, ester, and other synthetics as well as mineral oils. It also references documents addressing compatibility of refrigerants and lubricants with metals, plastics, elastomers, motor insulation, and other materials used in refrigerant circuits. Incomplete citations or abstracts are provided for some documents to accelerate availability of the information and will be completed or replaced in future updates.

  17. State Analysis Database Tool

    NASA Technical Reports Server (NTRS)

    Rasmussen, Robert; Bennett, Matthew

    2006-01-01

    The State Analysis Database Tool software establishes a productive environment for collaboration among software and system engineers engaged in the development of complex interacting systems. The tool embodies State Analysis, a model-based system engineering methodology founded on a state-based control architecture (see figure). A state represents a momentary condition of an evolving system, and a model may describe how a state evolves and is affected by other states. The State Analysis methodology is a process for capturing system and software requirements in the form of explicit models and states, and defining goal-based operational plans consistent with the models. Requirements, models, and operational concerns have traditionally been documented in a variety of system engineering artifacts that address different aspects of a mission s lifecycle. In State Analysis, requirements, models, and operations information are State Analysis artifacts that are consistent and stored in a State Analysis Database. The tool includes a back-end database, a multi-platform front-end client, and Web-based administrative functions. The tool is structured to prompt an engineer to follow the State Analysis methodology, to encourage state discovery and model description, and to make software requirements and operations plans consistent with model descriptions.

  18. The Cambridge Structural Database

    PubMed Central

    Groom, Colin R.; Bruno, Ian J.; Lightfoot, Matthew P.; Ward, Suzanna C.

    2016-01-01

    The Cambridge Structural Database (CSD) contains a complete record of all published organic and metal–organic small-molecule crystal structures. The database has been in operation for over 50 years and continues to be the primary means of sharing structural chemistry data and knowledge across disciplines. As well as structures that are made public to support scientific articles, it includes many structures published directly as CSD Communications. All structures are processed both computationally and by expert structural chemistry editors prior to entering the database. A key component of this processing is the reliable association of the chemical identity of the structure studied with the experimental data. This important step helps ensure that data is widely discoverable and readily reusable. Content is further enriched through selective inclusion of additional experimental data. Entries are available to anyone through free CSD community web services. Linking services developed and maintained by the CCDC, combined with the use of standard identifiers, facilitate discovery from other resources. Data can also be accessed through CCDC and third party software applications and through an application programming interface. PMID:27048719

  19. Fiber pixelated image database

    NASA Astrophysics Data System (ADS)

    Shinde, Anant; Perinchery, Sandeep Menon; Matham, Murukeshan Vadakke

    2016-08-01

    Imaging of physically inaccessible parts of the body such as the colon at micron-level resolution is highly important in diagnostic medical imaging. Though flexible endoscopes based on the imaging fiber bundle are used for such diagnostic procedures, their inherent honeycomb-like structure creates fiber pixelation effects. This impedes the observer from perceiving the information from an image captured and hinders the direct use of image processing and machine intelligence techniques on the recorded signal. Significant efforts have been made by researchers in the recent past in the development and implementation of pixelation removal techniques. However, researchers have often used their own set of images without making source data available which subdued their usage and adaptability universally. A database of pixelated images is the current requirement to meet the growing diagnostic needs in the healthcare arena. An innovative fiber pixelated image database is presented, which consists of pixelated images that are synthetically generated and experimentally acquired. Sample space encompasses test patterns of different scales, sizes, and shapes. It is envisaged that this proposed database will alleviate the current limitations associated with relevant research and development and would be of great help for researchers working on comb structure removal algorithms.

  20. French Crossings: II. Laughing Over Boundaries.

    PubMed

    Jones, Colin

    Under the generic title, 'French Crossings', this Presidential Address explores the history of laughter in French society, and humour's potential for trangressing boundaries. It focuses on the irreverent and almost entirely unknown book of comic drawings entitled Livre de caricatures tant Bonnes que mauvaises (Book of Caricatures, both Good and Bad), that was composed between the 1740s and the mid-1770s by the luxury Parisian embroiderer and designer, Charles-Germain de Saint-Aubin, and his friends and family. The bawdy laughter that the book seems intended to provoke gave it its nickname of the Livre de culs (Book of Arses). Yet despite the scatological character of many of the drawings, the humour often conjoined lower body functions with rather cerebral and erudite wit. The laughter provoked unsparingly targeted and exposed to ridicule the social elite, cultural celebrities and political leaders of Ancien Regime France. This made it a dangerous object, which was kept strictly secret. Was this humour somehow pre- or proto-Revolutionary? In fact, the work is so embedded in the culture of the Ancien Regime that 1789 was one boundary that the work signally fails to cross.