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Sample records for post marketing observational

  1. [The importance of defining methodology for post-marketing observational studies on cardiovascular therapies].

    Science.gov (United States)

    Pelliccia, Francesco; Barillà, Francesco; Tanzilli, Gaetano; Viceconte, Nicola; Paravati, Vincenzo; Mangieri, Enrico; Gaudio, Carlo

    2017-01-01

    In recent years, a growing number of observational studies in cardiology have been carried out following the criticism that rigid design of randomized clinical trials produces information that is not applicable to the general patient. This approach is very common in several branches of medicine, first of all oncology, but has often been considered marginal in cardiology. The recent introduction of new oral anticoagulants (NOACs) on the market, however, has seen a proliferation of "real-life" studies, drawing the attention of cardiologists to the advantages and limitations of post-marketing studies. NOACs have been approved for use on the basis of large randomized clinical trials that have clearly documented their efficacy and safety. Since they have become available, the analysis of phase IV data has been considered crucial and therefore a great amount of information on the use of NOACs in daily practice has become available. It should be considered, however, that the possibility exists that results obtained from "real-world" studies, which do not apply rigid scientific criteria, may lead to incorrect conclusions. Accordingly, it is mandatory to fully define the operational standards of observational studies. All the protagonists of post-marketing analysis (physicians, epidemiologists, pharmacologists, statisticians) should handle the data strictly in order to ensure their reliability and comparability with other studies. To this end, it is crucial that researchers follow rigorous operational protocols for phase IV studies. Briefly, any "real-life" study should be prospective and adhere to what is prespecified by the research protocol - which must illustrate the background and rationale of the study, define its primary endpoint, and detail the methods, i.e. study design, population and variables.

  2. Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence.

    Science.gov (United States)

    Kuwayama, Yasuaki; Hashimoto, Masako; Kakegawa, Reiko; Nomura, Akio; Shimada, Fumiki

    2017-06-01

    The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit-risk balance. This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan. Long-term IOP and safety data were collected. Of the 4502 patients registered from 553 medical institutions, 4265 patients were analyzed. The majority of patients had normal-tension glaucoma (44.4%) and primary open-angle glaucoma (37.8%), and patients with ocular hypertension constituted 7.0%. Treatment patterns with tafluprost during the study period were as follows: naïve monotherapy (48.1%), switching monotherapy (18.4%), and concomitant therapy (33.5%). In all patients analyzed, mean IOP was significantly reduced from 18.6 ± 5.9 mmHg (month 0) to 15 mmHg or below throughout the 2-year observation period after initiation of tafluprost. Significant IOP-lowering effects were shown in various treatment patterns and disease types. Adverse reactions were observed in 795 patients (18.64%). Major adverse reactions included eyelid pigmentation, ocular hyperemia, eyelash changes, eyelid hypertrichosis, and iris hyperpigmentation. Kaplan-Meier curves showed that 84.6% and 76.1% of patients were persistent on tafluprost for 1 and 2 years, respectively, when discontinuation due to insufficient efficacy or adverse events was defined as a treatment failure event. Furthermore, among treatment-naïve patients (n = 2304), the persistency rates on tafluprost monotherapy were 77.0% for 1 year and 67.0% for 2 years. Tafluprost showed significant long-term IOP-lowering effects regardless of treatment patterns or diagnosis, with

  3. Itopride in the treatment of functional dyspepsia in Chinese patients: a prospective, multicentre, post-marketing observational study.

    Science.gov (United States)

    Sun, Jing; Yuan, Yao-Zong; Holtmann, Gerald

    2011-12-01

    Prokinetic agents are commonly used in the symptomatic treatment of functional dyspepsia (FD). Safety or efficacy issues associated with the use of available prokinetics, such as metoclopramide, domperidone, cisapride and mosapride, mean there is a need for an effective and well tolerated prokinetic agent. Itopride is a novel prokinetic agent with a dual mode of action, good safety profile and documented efficacy in placebo-controlled trials. The objective of this study was to assess the effectiveness and safety of itopride in the management of FD. This was a prospective, multicentre, post-marketing observational study carried out in private outpatient clinics throughout China. The study included patients with symptomatic FD aged ≥18 years. Patients were prescribed itopride 50 mg three times daily before meals for 4 weeks, after which there was a 2-week follow-up period during which they did not take itopride. Effectiveness and tolerability data obtained from patients who completed 4 weeks of therapy were analysed. The treatment response rate after 4 weeks was measured by patient global assessment; scores at the end of treatment were compared with baseline scores. Response rate based on symptom scoring was also measured after 4 weeks, with an effective treatment being defined as a symptom improvement of ≥50%. In total, 587 patients with FD were enrolled. The mean ± SD difference in the total symptom score before and after the 4-week treatment period was -5.62 ± 3.27, corresponding to a 69.23 ± 26.53% reduction from baseline (p Itopride was an effective and well tolerated drug in the management of FD in this patient population.

  4. Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study – PRIME study

    Directory of Open Access Journals (Sweden)

    Shah K

    2017-05-01

    Full Text Available Kshitij Shah,1 Omvijay B Chaudhari,2 Palash Gupta,3 R Hom Chaudhuri,4 Ranjan Kamilya,5 Shreedhar S Kulkarni,6 S Subbaiah,7 Zubair H Sorathia,8 Gauri Billa9 1MS Orthopedic, Prime Hospital, Andheri (West, 2Vatsalya Nursing Home, Kalyan (West, Mumbai, 3Dr. Palash Gupta Clinic, Rohini, New Delhi, 4Homchaudhuri’s Clinic, 5Apollo Gleneagles Hospital, Kolkata, West Bengal, 6Amrit Clinic, Matunga, Mumbai, 7Subbaiah’s Clinic, West Mambalam, Chennai, 8Medicare Hospital, Marol, Andheri East, 9Medical Services, Abbott Healthcare Pvt. Ltd, Mulund (West, Mumbai, Maharashtra, India Objective: To assess the effectiveness, overall tolerability, and gastrointestinal (GI tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg] in symptomatic treatment of severe acute pain in physician’s routine clinical practice. Materials and methods: In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18–60 years with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at baseline, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5. Results: A total of 351 patients (mean age 44.2 years; male 43%; female 57% were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (p<0.0001. The number of patients with severe intensity of pain reduced from 100% at baseline to 18.3% at day 2 and 6.96% at day 5. According to the patient assessment, 68.36% of patients reported tolerability as “very good to good”, whereas according to physician’s assessment, “very good to good” tolerability was reported in 68.27% of patients. Five (1.43 % patients discontinued the study because of adverse drug reaction. Five patients developed nine GI-related events of moderate intensity. Two patients

  5. Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance.

    Science.gov (United States)

    Mathieu, Chantal; Kozlovski, Plamen; Paldánius, Päivi M; Foley, James E; Modgill, Vikas; Evans, Marc; Serban, Carmen

    2017-08-01

    Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit-risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.

  6. Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report

    Science.gov (United States)

    Terao, Takeshi; Ishida, Atsuko; Kimura, Toshifumi; Yoshida, Mitsuhiro; Hara, Terufumi

    2017-01-01

    Background A post-marketing surveillance (PMS) study was conducted with a 1-year observation period to assess the safety and efficacy of lamotrigine in routine clinical practice in patients with bipolar disorder (BD). Patients and methods Central enrollment method was used to recruit patients diagnosed with BD who were being treated for the first time with lamotrigine to prevent the recurrence/relapse of BD mood episodes. Adverse drug reactions (ADRs) and recurrence/relapse were assessed. Improvement of mania and depression was also assessed using the Hamilton’s Rating Scale for Depression (HAM-D) and the Young Mania Rating Scale (YMRS) at treatment initiation, 4–6 months post treatment initiation, and 10–12 months post treatment initiation. Results A total of 237/989 patients (24.0%) reported ADRs, most commonly rash (9.1%), and the incidence of serious ADRs was 3.3% (33/989 patients). Skin disorders occurred in 130 patients (13.1%), mostly within 8 weeks post treatment. A total of 237/703 patients (33.7%) experienced recurrence/relapse of mood episodes. The 25th percentile of the time to recurrence/relapse of mood episodes was 105 days. Remission of depression symptoms (HAM-D ≤7) occurred in 147/697 patients (21.1%) at treatment initiation, rising to 361 patients (67.4%) at 10–12 months post treatment. Remission of manic symptoms (YMRS ≤13) occurred in 615/676 patients (91.0%) at treatment initiation, rising to 500 patients (97.3%) at 10–12 months post treatment. Conclusion The results of this PMS study suggest that lamotrigine is a well-tolerated and effective drug for preventing recurrence/relapse of BD in clinical practice. PMID:28652744

  7. Evaluation of Aryoseven Safety (Recombinant Activated Factor VII) in Patients with Bleeding Disorders (An Observational Post-Marketing Surveillance Study).

    Science.gov (United States)

    Toogeh, Gholamreza; Abolghasemi, Hassan; Eshghi, Peyman; Managhchi, Mohammadreza; Shaverdi-Niasari, Mohammadreza; Karimi, Katayoon; Roostaei, Samin; Emran, Neda; Abdollahi, Alireza

    2016-01-01

    Recombinant activated factor VII induces hemostasis in patients with coagulopathy disorders. AryoSeven™ as a safe Iranian Recombinant activated factor VII has been available on our market. This study was performed to establish the safety of AryoSeven on patients with coagulopathy disorder. This single-center, descriptive, cross sectional study was carried out in Thrombus and Homeostasis Research Center ValiAsr Hospital during 2013-2014. Fifty one patients with bleeding disorders who received at least one dose of Aryoseven were enrolled. Patients' demographic data and adverse effect of drug and reaction related to Aryoseven or previous usage of Recombinant activated FVII were recorded in questionnaires. Finally data were analyzed to compare side effects of Aryoseven and other Recombinant activated FVII brands. Aryoseven was prescribed for 51 Patients. Of all participants with mean age 57.18+21.38 yr, 31 cases were male and 26 subjects had past history of recombinant activated FVII usage. Glanzman was the most frequent disorder followed by congenital FVII deficiency, hemophilia with inhibitors, factor 5 deficiency, acquired hemophilia, hemophilia A with inhibitor, and hemophilia A or B with inhibitor. The majority of bleeding episodes had occurred in joints. Three patients (5.9%) complained about adverse effects of Aryoseven vs. 11.5 % about adverse effects of other brands. However this difference was not significant, statistically. Based on monitor patients closely for any adverse events, we concluded that Aryoseven administration under careful weighing of benefit versus potential harm may comparable with other counterpart drugs.

  8. The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese male patients with osteoporosis.

    Science.gov (United States)

    Kondo, Satoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Furuno, Yuko; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

    2018-03-12

    We conducted a post-marketing observational study to investigate the safety and effectiveness of eldecalcitol for the treatment of osteoporosis in a Japanese clinical setting. The observation period was 12 months for women and 36 months for men. The final results for the female patients have already been published. In this article, the final results for the male patients are reported. A total of 470 male osteoporosis patients were enrolled. The safety analysis set included 431 patients (mean age, 76.8 years; mean ± SD follow-up period, 631.0 ± 450.3 days), and 175 patients continued treatment throughout the 3-year observational period. Adverse drug reactions (ADRs) were reported in 28 patients (6.49%); the most common ADRs were hypercalcemia (1.16%) and renal impairment (1.16%). Serious ADRs were reported in 5 patients (1.16%). Mean serum calcium was within the normal range throughout the observation period. The cumulative incidence of new vertebral and nonvertebral fractures at 36 months, estimated by Kaplan-Meier analysis, was 10.23 and 4.06%, respectively. At the last observation, mean lumbar spine bone mineral density was 3.49% higher (P effectiveness of eldecalcitol for the treatment of Japanese male osteoporosis patients was confirmed in clinical practice. Careful monitoring of serum calcium and estimated glomerular filtration rate, both before and during treatment, is necessary to minimize the risk of hypercalcemia and renal impairment while maximizing the effectiveness of eldecalcitol.

  9. Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study.

    Science.gov (United States)

    Yahno, Nikolay N; Fedotova, Anastasia V

    2017-01-01

    In a prospective, non-blinded, uncontrolled, multicenter, post-marketing, observational study (FRIENDS; NCT02043197), fluvoxamine (50-300 mg/day for 90 days) was effective for the treatment of depression in 299 adult patients (age ≥18 years) with neurological disorders at baseline. The therapeutic effect of fluvoxamine was measured by means of changes in the Hospital Anxiety and Depression Scale depression and anxiety scores (HADS-D and HADS-A, respectively), global severity of illness, and clinical condition (measured using the Clinical Global Improvement [CGI] scale). The mean HADS-D subscale score at baseline in the per-protocol cohort (n=296) was 11.7±3.1 points and the corresponding mean HADS-A score was 12.6±3.2. Significant ( P 85%) recorded reductions versus baseline in both indices. In the CGI-based assessment, most evaluated patients (>200) experienced moderate to very substantial clinical improvement, with no or limited side effects. Significant improvements were also recorded in the exploratory outcomes of sleep quality, assessed using the Insomnia Severity Index, and cognitive function, assessed using the Montreal Cognitive Assessment ( P effective and well tolerated for the treatment of depression in the context of neurological disorders. The effects on the exploratory endpoints of this research merit evaluation in controlled trials.

  10. Efficacy and tolerability of rasagiline in daily clinical use--a post-marketing observational study in patients with Parkinson's disease.

    Science.gov (United States)

    Reichmann, H; Jost, W H

    2010-09-01

    The MAO-B inhibitor rasagiline is indicated for the treatment of idiopathic Parkinson's disease (PD), and its use is supported by evidence from large-scale, controlled clinical studies. The post-marketing observational study presented here investigated the efficacy and tolerability of rasagiline treatment (monotherapy or combination therapy) in daily clinical practice. The study included patients with idiopathic PD who received rasagiline (recommended dose 1 mg, once daily) as monotherapy or combination therapy. The treatment and observation period was approximately 4 months. Outcome measures included the change from baseline in the Columbia University Rating Scale (CURS), the Unified PD Rating Scale fluctuation subscale, daily OFF time (patient home diaries) and the PD Questionnaire-39. Adverse drug reactions/adverse events (ADRs/AEs) and the physician's global judgement of tolerability and efficacy were also examined. Overall, 754 patients received rasagiline during the study. Patients treated with rasagiline (monotherapy or combination therapy) showed significant improvements from baseline in symptom severity (including classical motor and non-classical motor/non-motor symptoms) and quality of life (QoL). Patients receiving combination therapy also experienced significant reductions in daily OFF time. Tolerability was rated as good/very good in over 90% of patients. In daily clinical practice, monotherapy or combination therapy with rasagiline is able to improve PD symptoms, reduce OFF time, and improve QoL, whilst demonstrating favourable tolerability. In addition, rasagiline has a simple dosing schedule of one tablet, once daily, with no titration. These results are consistent with the pivotal rasagiline clinical studies (TEMPO, LARGO and PRESTO).

  11. Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study

    Directory of Open Access Journals (Sweden)

    Yahno NN

    2017-11-01

    Full Text Available Nikolay N Yahno,1 Anastasia V Fedotova2 1Neurology Department, I.M. Sechenov First Moscow State Medical University, 2Neurology Department, Additional Professional Education Faculty, Pirogov Russian National Research Medical University, Moscow, Russian Federation Abstract: In a prospective, non-blinded, uncontrolled, multicenter, post-marketing, observational study (FRIENDS; NCT02043197, fluvoxamine (50–300 mg/day for 90 days was effective for the treatment of depression in 299 adult patients (age ≥18 years with neurological disorders at baseline. The therapeutic effect of fluvoxamine was measured by means of changes in the Hospital Anxiety and Depression Scale depression and anxiety scores (HADS-D and HADS-A, respectively, global severity of illness, and clinical condition (measured using the Clinical Global Improvement [CGI] scale. The mean HADS-D subscale score at baseline in the per-protocol cohort (n=296 was 11.7±3.1 points and the corresponding mean HADS-A score was 12.6±3.2. Significant (P<0.0001 improvements in both scores were recorded during fluvoxamine treatment and later follow-up. Most patients (>85% recorded reductions versus baseline in both indices. In the CGI-based assessment, most evaluated patients (>200 experienced moderate to very substantial clinical improvement, with no or limited side effects. Significant improvements were also recorded in the exploratory outcomes of sleep quality, assessed using the Insomnia Severity Index, and cognitive function, assessed using the Montreal Cognitive Assessment (P<0.0001 vs baseline for both. No death or serious adverse drug reactions were reported during the study. The results of this observational study affirm that fluvoxamine is effective and well tolerated for the treatment of depression in the context of neurological disorders. The effects on the exploratory endpoints of this research merit evaluation in controlled trials. Keywords: depression, anxiety, fluvoxamine

  12. The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese patients with osteoporosis: interim report.

    Science.gov (United States)

    Saito, Hitoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Yatomi, Sawako; Nihojima, Shigeru; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

    2017-07-01

    This large-scale post-marketing surveillance study was conducted to assess the safety and effectiveness of eldecalcitol treatment in patients with osteoporosis in a Japanese clinical setting. A total of 3567 patients with osteoporosis were enrolled and received eldecalcitol 0.75 μg/day for 12 months. For this interim report, 3285 patients were eligible for analysis. Mean age was 74.9 ± 8.7 years; 86.8 % (2854/3285) were women. There were 142 reported adverse drug reactions (ADRs) in 129 patients (3.92 % of the total 3285 patients): the most common were hypercalcemia and increased blood calcium (0.88 %), renal impairment (0.27 %), abdominal discomfort (0.24 %), constipation (0.24 %), and pruritus (0.24 %). The incidence of ADRs was 5.10 % in men and 3.74 % in women. Although 10 serious ADRs were reported in 9 patients (0.27 %), no clinically significant safety issues were identified. Incidence of hypercalcemia or increased blood calcium was 8.47 % in patients with renal impairment and only 0.74 % in patients without renal impairment. At last observation, the incidence of new vertebral and nonvertebral fractures was 2.44 % and 1.70 %, respectively. There was a significant increase in bone mineral density at the lumbar spine and distal radius. The bone turnover markers BAP, serum NTX, urinary NTX, and TRACP-5b were suppressed by eldecalcitol treatment in both sexes. In conclusion, consistent with the findings of the phase III pivotal clinical trial, eldecalcitol was shown to have a favorable safety profile and effectiveness in Japanese patients with osteoporosis. However, periodic measurements of serum calcium were required to prevent occurrence of hypercalcemia during eldecalcitol treatment, especially in patients with renal impairment.

  13. Observability of market daily volatility

    Science.gov (United States)

    Petroni, Filippo; Serva, Maurizio

    2016-02-01

    We study the price dynamics of 65 stocks from the Dow Jones Composite Average from 1973 to 2014. We show that it is possible to define a Daily Market Volatility σ(t) which is directly observable from data. This quantity is usually indirectly defined by r(t) = σ(t) ω(t) where the r(t) are the daily returns of the market index and the ω(t) are i.i.d. random variables with vanishing average and unitary variance. The relation r(t) = σ(t) ω(t) alone is unable to give an operative definition of the index volatility, which remains unobservable. On the contrary, we show that using the whole information available in the market, the index volatility can be operatively defined and detected.

  14. Energy market opportunities post-Maui

    International Nuclear Information System (INIS)

    Saha, G.

    1995-01-01

    As supply from the Maui and other existing producing fields decline, petroleum explorers and developers need to address the question who will be the indigenous oil and gas customers post Maui? This paper discusses major macro- and micro-environmental trends which will influence likely market opportunities. Two sub-markets are examined. First, what trends impact on current oil and gas customers. Second, what other new customers might arise. The macro-environment trends cover important economic, political, legislation, socio-economic and technical parameters. The micro-environment trends cover energy market structures and pricing parameters. (Author)

  15. Design and analysis of post-marketing research.

    Science.gov (United States)

    Zhou, Xiao-Hua Andrew; Yang, Wei

    2013-07-01

    A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.

  16. Farmers’ Markets: Positive Feelings of Instagram Posts

    Directory of Open Access Journals (Sweden)

    Ladislav Pilař

    2016-01-01

    Full Text Available With increasing consumer requirements, farmers and vendors see the importance of social media as a marketing tool to engage with consumers. In particular, on a more personal level for reasons of brand management. Instagram is becoming increasingly popular as a marketing communication tool. The aim of this paper is to identify areas that users evaluate in terms of positive feelings in connection with farmers’ markets. The results are based on the analysis of the worldwide, and Czech, instagram social network. Instagram posts were identified on the basis of keywords, such as #farmarsketrhy and #farmersmarkets. The results of the study are based on 100,000 contributions on Instagram made by 55,632 users. The analysis contains 1,357,812 ‘unique’ words. The results identified six major areas (1 Healthy (2 Good (3 Great (4 Happy (5 Nice (6 Perfect. An appropriately posted hashtag indicated the positive feelings that were evoked and then assigned to a matching category. The research results are used to identify group characteristics that exert these positive feelings while visiting farmers’ markets. These results can be used to build communications campaigns for farmers’ markets. They can also be used as a basis for further research in defining the behaviour of farmers’ markets visitors, based on cultural differences arising from geographic location.

  17. The Market for Fake Observations

    OpenAIRE

    Brekke, Kjellr Arne; Nilsen , Tore

    2011-01-01

    We show how increased competition in a media market may have implications for the competition between firms that are advertising in that medium. We apply a simple model of a product market with network externalities where firms buy advertising space in a media market and find that there is more entry in the product market, the more competitive the media market is. The paper is the first combining a study of media markets with a behavioral foundation of how advertising affects the demand for t...

  18. Progressing towards post-2012 carbon markets

    Energy Technology Data Exchange (ETDEWEB)

    Soeren Luetken, S; Holm Olsen, K

    2011-11-15

    Confronting the end of the first Kyoto Commitment period in 2012 with no agreed outcome for global cooperation on future emission reductions, there is an urgent need to look for new opportunities for public and private cooperation to drive broad-based progress in living standards and keep projected future warming below the politically agreed 2 degrees Celsius. Responding jointly to these global challenges the United Nations environmental Program (UNEP) and its UNEP Risoe Centre (URC) have in cooperation with the Global Green Growth Institute (GGGI) prepared the Perspectives 2011. The publication focuses on the role of carbon markets in contributing to low carbon development and new mechanisms for green growth, as one core area of action to address the challenges noted above. The publication explores in ten articles, how carbon markets at national, regional and global levels can be developed and up-scaled to sustain the involvement of the private sector in leveraging finance and innovative solutions to reduce greenhouse gas emissions. The titles of the ten articles are: 1) Fragmentation of international climate policy - doom or boom for carbon markets?; 2) Perspectives on the EU carbon market; 3) China carbon market; 4) The national context of U.S. state policies for a global commons problem; 5) Mind the gap - the state-of-play of Canadian greenhouse gas mitigation; 6) Role of the UN and multilateral policies in integrating an increasingly fragmented global carbon market; 7) Making CDM work for poor and rich Africa beyond 2012 - a series of dos and don'ts; 8) Voluntary market - future perspectives; 9) Sectoral approaches as a way forward for the carbon market?; 10) The Durban outcome - a post 2012 framework approach for green house gas markets. (LN)

  19. Progressing towards post-2012 carbon markets

    Energy Technology Data Exchange (ETDEWEB)

    Soeren Luetken, S.; Holm Olsen, K.

    2011-11-15

    Confronting the end of the first Kyoto Commitment period in 2012 with no agreed outcome for global cooperation on future emission reductions, there is an urgent need to look for new opportunities for public and private cooperation to drive broad-based progress in living standards and keep projected future warming below the politically agreed 2 degrees Celsius. Responding jointly to these global challenges the United Nations environmental Program (UNEP) and its UNEP Risoe Centre (URC) have in cooperation with the Global Green Growth Institute (GGGI) prepared the Perspectives 2011. The publication focuses on the role of carbon markets in contributing to low carbon development and new mechanisms for green growth, as one core area of action to address the challenges noted above. The publication explores in ten articles, how carbon markets at national, regional and global levels can be developed and up-scaled to sustain the involvement of the private sector in leveraging finance and innovative solutions to reduce greenhouse gas emissions. The titles of the ten articles are: 1) Fragmentation of international climate policy - doom or boom for carbon markets?; 2) Perspectives on the EU carbon market; 3) China carbon market; 4) The national context of U.S. state policies for a global commons problem; 5) Mind the gap - the state-of-play of Canadian greenhouse gas mitigation; 6) Role of the UN and multilateral policies in integrating an increasingly fragmented global carbon market; 7) Making CDM work for poor and rich Africa beyond 2012 - a series of dos and don'ts; 8) Voluntary market - future perspectives; 9) Sectoral approaches as a way forward for the carbon market?; 10) The Durban outcome - a post 2012 framework approach for green house gas markets. (LN)

  20. Considering the post-1995 enrichment market

    International Nuclear Information System (INIS)

    Gunter, L.

    1994-01-01

    World demand for uranium enrichment services is likely to grow only a little over the next decade, from the current 28 million separative work units (SWU) per year to 33 MSWU per year. Much of the growth will come from Asia where nuclear generating capacity is still increasing. The current situation of the primary enrichment companies is summarized. The primary Western suppliers, Cogema, United States Enrichment Corporation and Urenco, are competing for increased market share in the USA, Europe and Asia as utilities purchase their post-1995 requirements. Entry of the Russian enrichment company, Tenex, into Western markets has been limited by trade restrictions. As a consequence of disarmament, blended weapons material has resulted in a surplus of low-enriched uranium. Together with over-capacity amongst the primary enrichers this has led to an expectation that reduced prices will be negotiable in the medium term. (3 figures). (UK)

  1. Effectiveness and tolerability of fixed-dose combination enalapril plus nitrendipine in hypertensive patients: results of the 3-month observational, post-marketing, multicentre, prospective CENIT study.

    Science.gov (United States)

    Sierra, Alejandro de la; Roca-Cusachs, Alejandro; Redón, Josep; Marín, Rafael; Luque, Manuel; Figuera, Mariano de la; Garcia-Garcia, Margarida; Falkon, Liliana

    2009-01-01

    Monotherapy with any class of antihypertensive drug effectively controls blood pressure (BP) in only about 50% of patients. Consequently, the majority of patients with hypertension require combined therapy with two or more medications. This study aimed to evaluate the effectiveness (systolic BP [SBP]/diastolic BP [DBP] control) and tolerability of the fixed-dose combination enalapril/nitrendipine 10 mg/20 mg administered as a single daily dose in hypertensive patients. This was a post-authorization, multicentre, prospective, observational study conducted in primary care with a 3-month follow-up. Patients throughout Spain with uncontrolled hypertension (> or =140/90 mmHg for patients without diabetes mellitus, or > or =130/85 mmHg for patients with diabetes) on monotherapy or with any combination other than enalapril + nitrendipine, or who were unable to tolerate their previous antihypertensive therapy, were recruited. Change from previous to study treatment was according to usual clinical practice. BP was measured once after 5 minutes of rest in the sitting position. Therapeutic response was defined as follows: 'controlled' meant controlled BP ( or =20 mmHg and in DBP of > or =10 mmHg. The main laboratory test parameters were documented at baseline and after 3 months. Patients aged >65 years, with diabetes, with isolated systolic hypertension (ISH; SBP > or =140 mmHg for patients without diabetes, SBP > or =130 mmHg for patients with diabetes) and who were obese (body mass index [BMI] > or =30 kg/m2) were analysed separately. Of 6537 patients included, 5010 and 6354 patients were assessed in effectiveness and tolerability analyses, respectively. In the tolerability analysis population, there were 3023 men (47.6%) and 3321 women (52.4%). The mean (+/- SD) age of the tolerability analysis group was 62.8 (+/- 10.7) years. A total of 71.1% of the patients presented at least one clinical cardiovascular risk factor other than hypertension, with the most frequent being

  2. Social Media Listening for Routine Post-Marketing Safety Surveillance.

    Science.gov (United States)

    Powell, Gregory E; Seifert, Harry A; Reblin, Tjark; Burstein, Phil J; Blowers, James; Menius, J Alan; Painter, Jeffery L; Thomas, Michele; Pierce, Carrie E; Rodriguez, Harold W; Brownstein, John S; Freifeld, Clark C; Bell, Heidi G; Dasgupta, Nabarun

    2016-05-01

    Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media ('social listening') to supplement established approaches for pharmacovigilance. Although social listening is commonly used for commercial purposes, there are only anecdotal reports of its use in pharmacovigilance. Health information posted online by patients is often publicly available, representing an untapped source of post-marketing safety data that could supplement data from existing sources. The objective of this paper is to describe one methodology that could help unlock the potential of social media for safety surveillance. A third-party vendor acquired 24 months of publicly available Facebook and Twitter data, then processed the data by standardizing drug names and vernacular symptoms, removing duplicates and noise, masking personally identifiable information, and adding supplemental data to facilitate the review process. The resulting dataset was analyzed for safety and benefit information. In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA(®)) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared with 15,650,108 total PTs representing 946 individual PTs in Facebook. Further analysis revealed that 26 % of posts also contained benefit information. Social media listening is an important tool to augment post-marketing safety surveillance. Much work remains to determine best practices for using this rapidly evolving data source.

  3. Safety and effectiveness of eribulin in Japanese patients with locally advanced or metastatic breast cancer: a post-marketing observational study.

    Science.gov (United States)

    Watanabe, Junichiro; Ito, Yoshinori; Ohsumi, Shozo; Mizutani, Mitsuhiro; Tashiro, Hideya; Sakurai, Kenichi; Takahashi, Masato; Saito, Tsuyoshi; Tsurutani, Junji; Mukai, Hirofumi; Yoshinami, Tetsuhiro; Takao, Shintaro; Yamamoto, Yasuhisa; Matsuoka, Toshiyuki; Iwase, Hirotaka; Iwata, Hiroji; Nakamura, Seigo; Saeki, Toshiaki

    2017-12-01

    Background This large-scale study was conducted to evaluate the safety and effectiveness of eribulin for the treatment of inoperable or recurrent breast cancer in real-world settings in Japan. Methods Between July and December 2011, eligible patients with inoperable or recurrent breast cancer receiving eribulin for the first time were centrally registered and observed for 1 year. Eribulin was administered intravenously (1.4 mg/m 2 ) on days 1 and 8 of every 3-week cycle. The primary endpoint was the frequency and intensity of adverse drug reactions (ADRs). Secondary endpoints included overall response rate (ORR) and time to treatment failure (TTF). Results Of 968 patients registered at 325 institutions, 951 and 671 were included in the safety and effectiveness analyses, respectively. In the safety population, ADRs were observed in 841 patients (88.4%). The most common (≥15% incidence) were neutropenia (66.6%), leukopenia (62.4%), lymphopenia (18.4%), and peripheral neuropathy (16.8%). The most common grade ≥ 3 ADRs (>5% incidence) were neutropenia (59.8%), leukopenia (50.5%), lymphopenia (16.1%), and febrile neutropenia (7.7%). In the effectiveness population, ORR was 16.5% (95% confidence interval: 13.7, 19.4). The median TTF was 127 days (95% confidence interval: 120, 134). Conclusions The safety and effectiveness profile of eribulin was consistent with prior studies. Eribulin had a favorable risk-benefit balance when used in real-world clinical settings.

  4. Provoking Reflective Thinking in Post Observation Conversations

    Science.gov (United States)

    Kim, Younhee; Silver, Rita Elaine

    2016-01-01

    We present a micro-analysis of post observation conversations between classroom teachers and mentors. Using the approach of conversation analysis, we show how the sequential organization of an episode (i.e., who initiates the interaction, question format used by mentors) could potentially serve to provoke or hinder teacher reflection. Our analysis…

  5. Market segmentation and analysis of Japan's residential post and beam construction market.

    Science.gov (United States)

    Joseph A. Roos; Ivan L. Eastin; Hisaaki Matsuguma

    2005-01-01

    A mail survey of Japanese post and beam builders was conducted to measure their level of ethnocentrism, market orientation, risk aversion, and price consciousness. The data were analyzed utilizing factor and cluster analysis. The results showed that Japanese post and beam builders can be divided into three distinct market segments: open to import...

  6. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

    Science.gov (United States)

    Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

    2017-06-01

    An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post-marketing

  7. Directory of Post-Secondary Retailing and Marketing Vocational Programs.

    Science.gov (United States)

    American Vocational Association, Inc., Washington, DC.

    This directory lists 357 general and 135 special retailing and marketing vocational programs at the post secondary level. Institutions vary somewhat in the identification of general programs; for example, they may be called retailing, merchandising, marketing, mid-management, or distributive education programs. Specialized programs offered by…

  8. Innovations in Post-Marketing Safety Research

    NARCIS (Netherlands)

    Stefánsdóttir, G.

    2012-01-01

    Safety surveillance is important during the entire life cycle of a drug. Pre-marketing trials have been shown to be ineffective in establishing the full safety profile of the drug, mainly due to their relatively small sample size and characteristics of the patients, which are usually younger and

  9. Post market surveillance in the german medical device sector - current state and future perspectives.

    Science.gov (United States)

    Zippel, Claus; Bohnet-Joschko, Sabine

    2017-08-01

    Medical devices play a central role in the diagnosis and treatment of diseases but also bring the potential for adverse events, hazards or malfunction with serious consequences for patients and users. Medical device manufacturers are therefore required by law to monitor the performance of medical devices that have been approved by the competent authorities (post market surveillance). Conducting a nationwide online-survey in the German medical device sector in Q2/2014 in order to explore the current status of the use of post market instruments we obtained a total of 118 complete data sets, for a return rate of 36%. The survey included manufacturers of different sizes, producing medical devices of all risk classes. The post market instruments most frequently reported covered the fields of production monitoring and quality management as well as literature observation, regulatory vigilance systems, customer knowledge management and market observation while Post Market Clinical Follow-up and health services research were being used less for product monitoring. We found significant differences between the different risk classes of medical devices produced and the intensity of use of post market instruments. Differences between company size and the intensity of instruments used were hardly detected. Results may well contribute to the development of device monitoring which is a crucial element of the policy and regulatory system to identify device-related safety issues. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Ontario's power market post November 11

    International Nuclear Information System (INIS)

    Murphy, P.

    2003-01-01

    This paper provides a review of Ontario's first year with an open electricity market. The year 2002 to 2003 had record energy demands with challenges on the supply side. In particular, generation availability was below expectations during the summer months. This demonstrated that price predictability and volatility needs to be addressed and investment in new power generation is needed in Ontario. Ontario demand forecasts outpace supply for the long term outlook. In addition, most of Ontario's generating plants are aging and will soon exceed their nominal service life, requiring major refurbishment or replacement. Decisions are needed now on the future of coal in Ontario's generation mix. It was also noted that transmission reinforcements are needed in the Greater Toronto Area (GTA). In the short term, consumers can expect delays in return to service of nuclear units, forced extensions to planned outages, and reduced outlook for energy from hydroelectric resources. It was noted that Ontario will continue to rely on imports, although emergency generation is being installed. 5 figs

  11. A large, multicentre, observational, post-marketing surveillance study of the 2:1 formulation of follitropin alfa and lutropin alfa in routine clinical practice for assisted reproductive technology.

    Science.gov (United States)

    Bühler, Klaus; Naether, Olaf G J; Bilger, Wilma

    2014-01-14

    Follicle-stimulating hormone (FSH) and luteinizing hormone (LH) both have a role to play in follicular development during the natural menstrual cycle. LH supplementation during controlled ovarian stimulation (COS) for assisted reproductive technology (ART) is used for patients with hypogonadotropic hypogonadism. However, the use of exogenous LH in COS in normogonadotropic women undergoing ART is the subject of debate. The aim of this study was to investigate characteristics of infertile women who received the 2:1 formulation of follitropin alfa and lutropin alfa (indicated for stimulation of follicular development in women with severe LH and FSH deficiency) in German clinical practice. A 3-year, multicentre, open-label, observational/non-interventional, post-marketing surveillance study of women (21-45 years) undergoing ART. Primary endpoint: reason for prescribing the 2:1 formulation of follitropin alfa and lutropin alfa. Secondary variables included: COS duration/dose; oocytes retrieved; fertilization; clinical pregnancy; ovarian hyperstimulation syndrome (OHSS). In total, 2220 cycles were assessed; at least one reason for prescribing the 2:1 formulation was given in 1834/2220 (82.6%) cycles. Most common reasons were: poor ovarian response (POR) (39.4%), low baseline LH (17.8%), and age (13.8%). COS: mean dose of the 2:1 formulation on first day, 183.1/91.5 IU; mean duration, 10.8 days. In 2173/2220 (97.9%) cycles, human chorionic gonadotrophin was administered. Oocyte pick-up (OPU) was attempted in 2108/2220 (95.0%) cycles; mean (standard deviation) 8.0 (5.4) oocytes retrieved/OPU cycle. Fertilization (≥1 oocyte fertilized) rates: in vitro fertilization (IVF), 391/439 (89.1%) cycles; intracytoplasmic sperm injection (ICSI)/IVF + ICSI, 1524/1613 (94.5%) cycles. Clinical pregnancy rate: all cycles, 25.9%; embryo transfer cycles, 31.3%. OHSS: hospitalization for OHSS, 8 (0.36%) cycles, Grade 2, 60 (2.7%), and Grade 3, 1 (0.05%). In German routine clinical

  12. Re-evaluation of the definition of remission on the 17-item Hamilton Depression Rating Scale based on recovery in health-related quality of life in an observational post-marketing study.

    Science.gov (United States)

    Sawamura, Jitsuki; Ishigooka, Jun; Nishimura, Katsuji

    2018-01-16

    Although a score of less than 7 for the 17-item Hamilton Depression Rating Scale (HAM-D17) has been widely adopted to define remission of depression, a full recovery from depression is closely related to the patient's quality of life as well. Accordingly, we re-evaluated this definition of remission using HAM-D17 in comparison with the corresponding score for health-related quality of life (HRQOL) measured by the SF-36. Using the data for depressive patients reported by GlaxoSmithKline K.K. (Study No. BRL29060A/863) in a post-marketing observational study of paroxetine, with a sample size of n = 722, multivariate logistic regression was performed with the HAM-D17 score as a dependent variable and with each of the eight domain scores of HRQOL (from the SF-36) transformed into a binominal form according to the national standard value for Japan. Then, area under curve of receiver operating characteristic analyses were conducted. Based on the obtained results, a multivariate analysis was performed using the HAM-D17 score in a binomial form with HAM-D17 as a dependent variable and with each of the eight HRQOL domain scores (SF-36) as binominalized independent variables. A cutoff value for the HAM-D17 score of 5 provided the maximum ROC-AUC at "0.864." The significantly associated scores of the eight HRQOL domains (SF-36) were identified for the HAM-D17 cutoff values of ≥5 and ≤4. The scores for physical functioning (odds ratio, 0.473), bodily pain (0.557), vitality (0.379), social functioning (0.540), role-emotion (0.265), and mental health (0.467) had a significant negative association with the HAM-D17 score (p < 0.05), and HRQOL domain scores for HAM-D17 ≥ 5 were significantly lower compared with those for HAM-D17 ≤ 4. A cutoff value for HAM-D17 of less than or equal to 4 was the best candidate for indicating remission of depression when the recovery of HRQOL is considered. Restoration of social function and performance should be considered

  13. Subcontracting, Posted Migrants and Labour Market Segmentation in Finland

    NARCIS (Netherlands)

    Lillie, Nathan

    Using evidence from the shipbuilding and construction industries in Finland, this article shows how trade union responses to the introduction of migrant workers can be conditioned by product markets. Growing numbers of posted workers, or intra-European Union work migrants employed via transnational

  14. Preferred supplier contracts in post-patent prescription drug markets.

    Science.gov (United States)

    Blankart, Carl Rudolf; Stargardt, Tom

    2016-02-22

    In recent years, the expiration of patents for large drug classes has increased the importance of post-patent drug markets. However, previous research has focused solely on patent drug markets. In this study, the authors evaluate the influence of preferred supplier contracts, the German approach to tendering, in post-patent drug markets using a hierarchical market share attraction model. The authors find that preferred supplier contracts are a powerful strategic instrument for generic manufacturers in a highly competitive environment. They quantify the effects of signing a preferred supplier contract and show that brand-name manufacturers are vulnerable to tendering. Therefore, brand-name manufacturers should readjust their strategies and consider including preferred supplier contracts in their marketing mix. In addition, the authors employ a simulation to demonstrate that a first-mover advantage might be gained from signing a preferred supplier contract. Furthermore, their results can be used as a blueprint for decision makers in the pharmaceutical industry to assess the market share effects of different contracting strategies regarding preferred supplier contracts.

  15. Arthritis, Rheumatism and Aging Medical Information System Post-Marketing Surveillance Program.

    Science.gov (United States)

    Singh, G

    2001-05-01

    The Arthritis, Rheumatism, and Aging Post-Marketing Surveillance Program (ARAMIS-PMS) is a collection of multicenter, prospective, noninterventional, observational longitudinal studies of patients with rheumatic diseases. The ARAMIS-PMS program aims to study patients in normal clinical setting to evaluate the real-life effectiveness, toxicity, and cost effectiveness of various medications used to treat rheumatic diseases.

  16. Enforcing Margin Squeeze Ex Post Across Converging Telecommunications Markets

    DEFF Research Database (Denmark)

    Bergqvist, Christian; Townsend, John

    , delay profitability or limit their ability to remain or expand on markets. However, traditional market definitions are being challenged by (1) the technological convergence of services and (2) innovative product offerings taking advantage of this convergence. Consumers now routinely purchase a bundle...... and innovation present both theoretical and practical difficulties for assessing “muddled margins” on telecoms markets. New and different enforcement approaches to exclusion will have to be formulated within the Article 102 framework and tested in the Courts. This may even require abstaining from applying...... Article 102 TFEU during material periods of convergence, and confining ex post enforcement activity to sector regulation, even when this is inferior for safeguarding effective competition....

  17. Futures market observations help in property evaluations

    International Nuclear Information System (INIS)

    Pickles, E.

    1994-01-01

    A standard approach to the valuation of petroleum properties and to project economics requires the calculation of present value of future cash flows. The technique is well-known and widely used in property evaluations, which are crucial to the acquisition activity in which independent producers recently have been so heavily engaged. But shortcomings of the standard approach also are well-known. Two significant problems are the choice of discount rate and the need to forecast prices. The appropriate discount rate depends upon the risk involved, and the correct relationship between risk and expected return may be difficult to determine. Oil price forecasts, meanwhile, are notoriously unreliable. These problems have led to adaptation of the option-valuation technique now widely and successfully used in the financial markets to the problem of valuing real assets, such as an oil field. In this context an option is the right, but not the obligation, to buy or sell an asset at some future time for a price (the exercise price) determined at the time the option is acquired. The important parameters are equilibrium price, volatility, and convenience yield, each of which can be projected on the basis of market data close at hand. Then the values can be combined with the production profile of an oil field to mathematically estimate present value. The valuation method is described

  18. Post-neoliberal electricity market 're-reforms' in Argentina. Diverging from market prescriptions?

    International Nuclear Information System (INIS)

    Haselip, James; Potter, Clive

    2010-01-01

    This paper focuses upon the policy and institutional change that has taken place within the Argentine electricity market since the country's economic and social crisis of 2001/2. As one of the first less developed countries (LDCs) to liberalise and privatise its electricity industry, Argentina has since moved away from the orthodox market model after consumer prices were frozen by the Government in early 2002 when the national currency was devalued by 70%. Although its reforms were widely praised during the 1990s, the electricity market has undergone a number of interventions, ostensibly to keep consumer prices low and to avert the much-discussed energy 'crisis' caused by a dearth of new investment combined with rising demand levels. This paper explores how the economic crisis and its consequences have both enabled and legitimised these policy and institutional amendments, while drawing upon the specifics of the post-neoliberal market 're-reforms' to consider the extent to which the Government appears to be moving away from market-based prescriptions. In addition, this paper contributes to sector-specific understandings of how, despite these changes, neoliberal ideas and assumptions continue to dominate Argentine public policy well beyond the postcrisis era. (author)

  19. Herpes zoster vaccine live: A 10 year review of post-marketing safety experience.

    Science.gov (United States)

    Willis, English D; Woodward, Meredith; Brown, Elizabeth; Popmihajlov, Zoran; Saddier, Patricia; Annunziato, Paula W; Halsey, Neal A; Gershon, Anne A

    2017-12-19

    Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed. A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. A Post-Modern Portfolio Management Approach on CEE Markets

    Directory of Open Access Journals (Sweden)

    Marcela-Daniela Todoni

    2015-01-01

    Full Text Available In this paper we apply two methods based on the Post-Modern Portfolio Management approach to study the risk-adjusted return of 5 major indices from emerging markets in Central and Eastern Europe during the period 2008-2013 on daily data. First, we involve the Sortino ratio. Secondly we propose an alternative method to the Sortino ratio for calculating the risk-adjusted return using a “multipliers method” to determine a global measure of risk. The Sortino ratio is used to score a portfolio's risk-adjusted returns relative to an investment target using downside risk and it measures the risk-adjusted return of an investment asset, portfolio or strategy. Our proposed alternative method is using the same logic and frame structure as Sortino ratio. However instead of downside risk we use the global risk calculated using multipliers. This is due to the fact that Sortino ratio does not distinguish between sub-cases possible – unrealized return area and loss area (negative return. Because of these we believe that it would be necessary a new method which to refine the results and take and into account the three areas. Our dataset includes 5 emerging markets: Romania (BET, Hungary (BUX, Czech Republic (PX, Bulgaria (SOFIX and Poland (WIG. For each of them we estimate the Sortino ratio of length windows 7, 14, 42 and 10, 21, 60. We used two variants for each target return, namely 2% and 5%. We consider Germany as a benchmark. After estimating the Sortino ratio and global risk calculated using “multipliers method”, we conducted a parallel analysis between Sortino ratio and the proposed alternative method. We split the analysis time span in two sub-periods, 2008-2010 and 2011-2013. As known, the higher the Sortino ratio, the better the risk-adjusted performance. The risk-adjusted return is influenced by the used target return and the used window. Analyzed data reveals that in case of Sortino ratio, Hungary has the best results and on the other side

  1. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

    Science.gov (United States)

    Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

    2015-01-01

    In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

  2. Labour Market Structure in Malaysia: Pre- and Post-Market Gender Comparison

    OpenAIRE

    Chung-Khain Wye; Rahmah Ismail

    2012-01-01

    Gender inequality in Malaysian labour market can be observed through labour force participation, unemployment, occupational distribution, top management employment involving decision making, and average monthly salary. Such an inequality generally works to the disadvantage of females, notwithstanding their outperformance of educational attainment over their males’ counterparts. Case study in the ICT services subsector points to the importance of imparting employability skills among females to...

  3. Uranium and nuclear market, the horizon post-Fukushima

    International Nuclear Information System (INIS)

    Lelièvre, F.

    2014-01-01

    Post-Fukushima, most countries have confirmed the importance of nuclear in their energy mix. We are seeing a level of new reactor construction unparalleled in decades with 61 nuclear power plants under construction and 5 plants under completion around the world. Global nuclear capacity is expected to increase by 50% over the next two decades. And more reactors mean more demand for uranium. However, uranium industry is currently grappling with near-term challenges, particularly in the form of depressed uranium prices. Recently several uranium producers announced production delays or cancellations in response to low prices, including major suppliers. As the current price levels, including long-term prices, are not sufficient to stimulate new production, future supplies are in question due to the long-lead nature of uranium mine development. Despite the near- to medium-term issues of our industry, the fundamentals of the uranium market remain strong over the long term - and these are the drivers of the Areva’s mining growth strategy over the coming years. (author)

  4. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

    Directory of Open Access Journals (Sweden)

    Ross JS

    2015-05-01

    Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance

  5. Post-project market review as a tool for stimulating commercialisation of knowledge creation projects

    NARCIS (Netherlands)

    Bout, L.Y.; Lombaers, J.H.M.; Constantinides, E.; Weerd-Nederhof, P.C. de

    2009-01-01

    Post-Project Reviews are mainly used as a tool to improve organisational learning (Busby, 1999; von Zedtwitz, 2002). However, the concept of post-project review can also be used as a tool to identify new market potential and to hand over technical knowledge from technical to marketing personnel (von

  6. Post-Project Market Review as a Tool for Stimulating Commercialisation of Knowledge Creation Projects

    NARCIS (Netherlands)

    Bout, Y.; Lombaers, Jaap H.M.; Constantinides, Efthymios; Fisscher, O.A.M.; de Weerd-Nederhof, Petronella C.; Oakey, R.; Groen, A.; Cook, G.; van der Sijde, P.

    2009-01-01

    Post-Project Reviews are mainly used as a tool to improve organisational learning (Busby, 1999; von Zedtwitz, 2002). However, post-project reviews can also be used as a tool to identify new market potential and to hand over technical knowledge from technical to marketing personnel (von Zedtwitz,

  7. How to Conduct Store Observations of Tobacco Marketing and Products.

    Science.gov (United States)

    Feld, Ashley L; Johnson, Trent O; Byerly, Katherine W; Ribisl, Kurt M

    2016-02-18

    As tobacco companies continue to heavily market their products at the point of sale, tobacco control groups seek strategies to combat the negative effects of this marketing. Store observations, which have been widely used by researchers and practitioners alike, are an excellent surveillance tool. This article provides a guide for public health practitioners interested in working in the tobacco retail environment by detailing the steps involved in conducting store observations of tobacco marketing and products including 1) obtaining tobacco product retailer lists, 2) creating measures, 3) selecting a mode of data collection, 4) training data collectors, and 5) analyzing data. We also highlight issues that may arise while in the field and provide information on disseminating results of store observations, including the potential policy implications.

  8. Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice--EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study.

    Science.gov (United States)

    Gautier, Jean-Francois; Martinez, Luc; Penfornis, Alfred; Eschwège, Eveline; Charpentier, Guillaume; Huret, Benoît; Madani, Suliya; Gourdy, Pierre

    2015-09-01

    The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice. This observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA1c effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials. Novo Nordisk A/S. ClinicalTrials.gov identifier, NCT01226966.

  9. Marketing Communications in the Post-Advertising Era.

    Science.gov (United States)

    Dilenschneider, Robert L.

    1991-01-01

    Challenges four commonly held myths about advertising and marketing effectiveness. Establishes the framework for a more comprehensive program of marketing communication involving traditional public relations, advertising, sales promotion, special events, along with new uses for public affairs work in marketing. (MG)

  10. Risk management and post-marketing surveillance of CNS drugs.

    Science.gov (United States)

    Henningfield, Jack E; Schuster, Charles R

    2009-12-01

    Drugs affecting the central nervous system span a broad range of chemical entities, dosage forms, indications, and risks. Unintended consequences include potential abuse and overdose in non-patient drug abusers, deliberate tampering of drug dosage forms, and criminal behavior associated with diversion. Regulators must consider diverse factors to find the appropriate conditions of approval to minimize unintended consequences while enabling a level of access desired by health care providers and patients. This commentary appears as part of a special issue of Drug and Alcohol Dependence that focuses on risk management and post-marketing surveillance and addresses key issues that pose real-world challenges to pharmaceutical sponsors and regulators in particular. For example, in the U.S., Controlled Substances Act drug scheduling can be considered a risk management strategy but its legal authorities and administrative processes are independent from those of risk management (including Risk Evaluation and Mitigation Strategies or REMS); better harmonization of these approaches is vital from drug development and regulatory perspectives. Risk management would ideally be implemented on a strong science foundation demonstrating that the tools employed to mitigate risks and ensure safe use are effective. In reality, research and evaluation of tools in this area is in its infancy and will necessarily be an evolutionary process; furthermore, there is little precedent for linking interventions and program evolution to unintended consequences such as regional outbreaks of abuse and diversion. How such issues are resolved has the potential to stimulate or stifle innovations in drug development and advance or imperil health care.

  11. State and market in post-reform Brazilian air transportation

    Directory of Open Access Journals (Sweden)

    Cristiano Fonseca Monteiro

    2009-10-01

    Full Text Available The changes that have taken place in Brazilian air transportation following the cycle of “market reforms” have turned this sector into an object of growing interest. This interest, in turn, has led to the emergence of a broad literature on the subject, characterized by the emphasis on an agenda of liberalization and the critique of State activism. The goal of the present article is to promote a confrontation between the different interpretations that have been made, incorporating the contributions of approaches inspired in Economic Sociology and in institutionalist analyses in order to draw attention to the importance that political variables, and the State in particular, have for economic performance. The post-reform context is characterized by an initial moment of greater State activism regarding air transportation, through re-initiation of stricter regulatory mechanisms and the re-opening of channels of dialog between state actors and firms. This is followed by a second moment in which state activism is abandoned, at the same time that the sector demonstrates expressive rates of growth, pushing it beyond its existing capacity and flight support infrastructure. This culminated in the episode known as the “apagão aéreo” (aerial black out Analysis of testimonies of state and private sector actors regarding the “blackout” enables us to identify the flaws in the responsible state apparatus as one of the factors that led to the “blackout”. Our conclusions draw attention to the importance of taking political factors into consideration, and particularly the role of the State, in the development of air transportation in Brazil. Keywords: commercial aviation, politics and economics, regulation, Economic Sociology, Historical Institutionalism.

  12. Effectiveness and Persistence of Liraglutide Treatment Among Patients with Type 2 Diabetes Treated in Primary Care and Specialist Settings: A Subgroup Analysis from the EVIDENCE Study, a Prospective, 2-Year Follow-up, Observational, Post-Marketing Study.

    Science.gov (United States)

    Martinez, Luc; Penfornis, Alfred; Gautier, Jean-Francois; Eschwège, Eveline; Charpentier, Guillaume; Bouzidi, Amira; Gourdy, Pierre

    2017-03-01

    The objective of this subgroup analysis is to investigate the effectiveness of liraglutide in people with type 2 diabetes (T2D) treated within the primary care physician (PCP) and specialist care settings. EVIDENCE is a prospective, observational study of 3152 adults with T2D recently starting or about to start liraglutide treatment in France. We followed patients in the PCP and specialist settings for 2 years to evaluate the effectiveness of liraglutide in glycemic control and body weight reduction. Furthermore, we evaluated the changes in combined antihyperglycemic treatments, the reasons for prescribing liraglutide, patient satisfaction, and safety of liraglutide in these two treatment settings. After 2 years of follow-up, 477 out of 1209 (39.0%) of PCP and 297 out of 1398 (21.2%) of specialist-treated patients still used liraglutide and maintained the glycated hemoglobin (HbA 1c ) target of <7.0%. Significant reductions from baseline were observed in both PCP- and specialist-treated cohorts in mean HbA 1c (-1.22% and -0.8%, respectively), fasting plasma glucose (FPG) concentration (-39 and -23 mg/dL), body weight (-4.4 and -3.8 kg), and body mass index (BMI) (-1.5 and -1.4 kg/m 2 ), all p < 0.0001. Reductions in HbA 1c and FPG were significantly greater among PCP- compared with specialist-treated patients, p < 0.0001 for both. Patient treatment satisfaction was also significantly increased in both cohorts. Reported gastrointestinal adverse events were less frequent among PCP-treated patients compared with specialist-treated patients (4.5% vs. 16.1%). Despite differences in demography and clinical characteristics of patients treated for T2D in PCP and specialty care, greater reduction in HbA 1c and increased glycemic control durability were observed with liraglutide in primary care, compared with specialist care. These data suggest that liraglutide treatment could benefit patients in primary care by delaying the need for further treatment

  13. [Application of Markov model in post-marketing pharmacoeconomic evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Xin; Su, Xia; Sun, Wentao; Xie, Yanming; Wang, Yongyan

    2011-10-01

    In post-marketing study of traditional Chinese medicine (TCM), pharmacoeconomic evaluation has an important applied significance. However, the economic literatures of TCM have been unable to fully and accurately reflect the unique overall outcomes of treatment with TCM. For the special nature of TCM itself, we recommend that Markov model could be introduced into post-marketing pharmacoeconomic evaluation of TCM, and also explore the feasibility of model application. Markov model can extrapolate the study time horizon, suit with effectiveness indicators of TCM, and provide measurable comprehensive outcome. In addition, Markov model can promote the development of TCM quality of life scale and the methodology of post-marketing pharmacoeconomic evaluation.

  14. [Thought on several problems of clinical revaluation of post-marketing herb research].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2010-06-01

    The revaluation of post-marketing herb is a complex research work, which concerns widely content and difficult to put it into practice. The starting of our country's revaluation post-marketing herb was comparatively late. It should profect it both in laws and regulations mechanism as well as technological specification. This article is try to focus on some attention problems in revaluation of postmarketing herb process. Such as the laws and regulations demand, the basement and the subject of revaluation of post-marketing herb.

  15. Bubbles, Post-Crash Dynamics, and the Housing Market

    OpenAIRE

    Crocker H. Liu; Adam Nowak; Stuart Rosenthal

    2014-01-01

    This paper documents and explains previously unrecognized post-crash dynamics following the collapse of a housing bubble. A simple model predicts that speculative developers ensure stable pre-crash relative prices between small and large homes while their post-crash exit allows small-home relative values to fall. Evidence from Phoenix supports the model. Although home prices doubled 2004-2006, relative prices of small-to-large homes remained nearly constant but then plummeted post-crash. As s...

  16. Towards disruptions in Earth observation? New Earth Observation systems and markets evolution: Possible scenarios and impacts

    Science.gov (United States)

    Denis, Gil; Claverie, Alain; Pasco, Xavier; Darnis, Jean-Pierre; de Maupeou, Benoît; Lafaye, Murielle; Morel, Eric

    2017-08-01

    This paper reviews the trends in Earth observation (EO) and the possible impacts on markets of the new initiatives, launched either by existing providers of EO data or by new players, privately funded. After a presentation of the existing models, the paper discusses the new approaches, addressing both commercial and institutional markets. New concepts for the very high resolution markets, in Europe and in the US, are the main focus of this analysis. Two complementary perspectives are summarised: on the one hand, the type of system and its operational performance and, on the other, the related business models, concepts of operation and ownership schemes.

  17. Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

    Science.gov (United States)

    Zeitoun, Jean-David; Baron, Gabriel; Vivot, Alexandre; Atal, Ignacio; Downing, Nicholas S; Ross, Joseph S; Ravaud, Philippe

    2018-01-15

    Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.gov through September 2014 for novel anticancer agents approved by both the US Food and Drug Administration and the European Medicines Agency between 2005 and 2010. All relevant post-marketing trials were classified according to indication, primary outcome, starting date, sponsors, and planned enrollment. Supplemental indications were retrieved from regulatory documents and publication rate was assessed by two different methods. Ten novel anticancer agents were eligible: five were indicated for hematologic malignancies and the remaining five for solid cancers (three for kidney cancer). We identified 2,345 post-marketing trials; 1,362 (58.1%) targeted an indication other than the originally approved one. We observed extreme variations among drugs in both number of post-marketing trials (range 8-530) and overall population to be enrolled per trial (1-8,381). Post-marketing trials assessed almost all types of cancers, the three most frequently studied cancers being leukemia, kidney cancer and myeloma. In all, 6.6% of post-marketing trials had a clinical endpoint as a primary outcome, and 35.9% and 54.1% had a safety or surrogate endpoint, respectively, as a primary outcome. Nine drugs obtained approval for supplemental indications. The publication rate at 10 years was 12.3 to 26.1% depending on the analysis method. In conclusion, we found that post-marketing research in oncology is highly heterogeneous and the publication rate of launched trials is low. © 2017 UICC.

  18. [Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Xin; Su, Xia; Yu, Jie; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.

  19. Uranium and Nuclear Market, the horizon post-Fukushima

    International Nuclear Information System (INIS)

    Leboucher, Isabelle

    2014-01-01

    Changes in installed nuclear capacity since 2011: ► Shrinking installed fleet ◆ Fukushima linked decision • Germany: phase out planned for 2022; • Belgium: government set dates for reactor closures (2015-2025); • Japan: fleet shut down; nevertheless, safety reviews for restart; • Switzerland: new energy law draft, new build under question; • USA: 5 early shutdowns announcements in 2013-2014. ► Some new build projects postponed ◆ USA: challenging under current electricity market conditions ◆ Europe: electricity prices and financing conditions are challenging in some countries (Bulgaria, Czech Republic,…)

  20. A post-marketing safety and efficacy assessment of a monoclonal antibody purified high-purity factor VIII concentrate.

    Science.gov (United States)

    Hay, C R; Lee, C A; Savidge, G

    1996-01-01

    The identification of infrequent side-effects of clotting factor concentrates, undetected by clinical trials, is facilitated by post-marketing surveillance. We present a post-marketing surveillance study in which 97 patients with haemophilia A, attending three haemophilia centres, were treated over a median follow-up period of 284 days (range 1-1074), and a total follow-up period of 30,080 days, with a pasteurized immunoaffinity purified factor VIII concentrate (Monoclate-P, Armour, Collegeville, USA). 5216 infusions, using 10,527,000 units of Monoclate-P, were carried out, mostly for routine haemarthroses or prophylaxis. No new inhibitors were observed during the study. At the start of the study 60/97 were HIV seropositive, 67/97 HBs antibody positive, 12 HbsAb negative and the remainder HBsAb positive before the study period. 13/14 tested were HAV seropositive at the beginning of the study. One patient became HAV seropositive during the study period, an infection thought to be community acquired. No other seroconversions were observed. Only one mild transfusion reaction was observed. This study confirms the safety and efficacy of Monoclate-P. Post-marketing surveillance or nationally organized pharmaco-vigilance should be practiced more widely to enable identification of low-frequency side-effects of treatment.

  1. [Exploration of how to formulate guidelines on post-marketing traditional Chinese medicine surveillance].

    Science.gov (United States)

    Zhang, Wen; Xie, Yan-Ming; Yu, Wen-Ya

    2013-09-01

    Combining the world health organization's (WHO), the United States and the European union's relevant laws and guidelines on post-marketing drug surveillance to judge the status of post-marketing surveillance of traditional Chinese medicine(TCM) in China. We found that due to the late start of post-marketing surveillance of traditional Chinese medicine, the appropriate guidelines are yet to be developed. Hence, hospitals, enterprises and research institutions do not have a shared foundation from which to compare their research results. Therefore there is an urgent need to formulate such post-marketing surveillance guidelines. This paper has used as guidance various technical documents such as, "procedures to formulate national standards" and "testing methods of management in formulating traditional Chinese medicine standards" and has combined these to produce a version of post-marketing surveillance particular to Chinese medicine in China. How to formulate these guidelines is discussed and procedures and methods to formulate technical specifications are introduced. These provide a reference for future technical specifications and will assist in the development of TCM.

  2. [Post-marketing surveillance on Guizhi Fuling Jiaonang based on literature review].

    Science.gov (United States)

    Wang, Gui-Qian; Gao, Yang; Liu, Fu-Mei; Wei, Rui-Li; Xie, Yan-Ming

    2018-02-01

    To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study. The patients were only treated with Guizhi Fuling Jiaonang in 56 studies, and Guizhi Fuling Jiaonang was combined with other drugs in 178 studies. The total ADRs/AEs incidence was 1.99% in single use of Guizhi Fuling Jiaonang, and 8.21% in combined use, but showing no severe adverse reactions. Gastrointestinal system damage was most common in mild ADRs. In this study, it was found that the overall safety of Guizhi Fuling Jiaonang was acceptable. The direct evidences of the drug's safety case reports were systematically analyzed in this study, but the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study was not sufficient, so the further studies on the safety of drug use should be conducted in order to provide better guidance for clinical medication. Copyright© by the Chinese Pharmaceutical Association.

  3. Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.

    Science.gov (United States)

    Yang, Yu; Zhou, Xiaofeng; Gao, Shuangqing; Lin, Hongbo; Xie, Yanming; Feng, Yuji; Huang, Kui; Zhan, Siyan

    2018-01-01

    Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance. An email survey of these core variables and eight general questions as well as follow-up inquiries on additional variables was conducted. These 40 core variables across the three EHDs and all variables in each EHD along with those in the US MS CDM and Observational Medical Outcomes Partnership (OMOP) CDM were compared for availability and labeled based on specific standards. All of the EHDs' custodians confirmed their willingness to share their databases with academic institutions after appropriate approval was obtained. The regional community-based database contained 1.19 million people in 2015 with 85% of core variables. Resampled annually nationwide, the national claims database included 5.4 million people in 2014 with 55% of core variables, and the EMR database included 3 million inpatients from 60 hospitals in 2015 with 80% of core variables. Compared with MS CDM or OMOP CDM, the proportion of variables across the three EHDs available or able to be transformed/derived from the original sources are 24-83% or 45-73%, respectively. These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

  4. Post-crisis asymmetries of the world market development of banking services

    Directory of Open Access Journals (Sweden)

    Vladyslav Тіpanov

    2011-09-01

    Full Text Available In the article there were analyzed theoretical backgrounds for defining the concept «banking service» by scientists from different countries: considered its main characteristics and classification, determined the key peculiarities of the world market functioning of banking services and its structure, found out the present-day developments of the world market of banking services under conditions of post-crisis period.

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

    Science.gov (United States)

    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.

  6. Environmental change challenges decision-making during post-market environmental monitoring of transgenic crops.

    Science.gov (United States)

    Sanvido, Olivier; Romeis, Jörg; Bigler, Franz

    2011-12-01

    The ability to decide what kind of environmental changes observed during post-market environmental monitoring of genetically modified (GM) crops represent environmental harm is an essential part of most legal frameworks regulating the commercial release of GM crops into the environment. Among others, such decisions are necessary to initiate remedial measures or to sustain claims of redress linked to environmental liability. Given that consensus on criteria to evaluate 'environmental harm' has not yet been found, there are a number of challenges for risk managers when interpreting GM crop monitoring data for environmental decision-making. In the present paper, we argue that the challenges in decision-making have four main causes. The first three causes relate to scientific data collection and analysis, which have methodological limits. The forth cause concerns scientific data evaluation, which is controversial among the different stakeholders involved in the debate on potential impacts of GM crops on the environment. This results in controversy how the effects of GM crops should be valued and what constitutes environmental harm. This controversy may influence decision-making about triggering corrective actions by regulators. We analyse all four challenges and propose potential strategies for addressing them. We conclude that environmental monitoring has its limits in reducing uncertainties remaining from the environmental risk assessment prior to market approval. We argue that remaining uncertainties related to adverse environmental effects of GM crops would probably be assessed in a more efficient and rigorous way during pre-market risk assessment. Risk managers should acknowledge the limits of environmental monitoring programmes as a tool for decision-making.

  7. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    Energy Technology Data Exchange (ETDEWEB)

    Balassy, Csilla [Medical University of Vienna, Vienna General Hospital, Department of Radiology, Division of General and Pediatric Radiology, Vienna (Austria); Roberts, Donna [Medical University of South Carolina, Department of Radiology, Charleston, SC (United States); Miller, Stephen F. [LeBonheur Children' s Hospital, Department of Radiology, Memphis, TN (United States)

    2015-11-15

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  8. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

    Science.gov (United States)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F

    2015-11-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

  9. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    International Nuclear Information System (INIS)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F.

    2015-01-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  10. Observations of market pigs following transport to a packing plant.

    Science.gov (United States)

    Kephart, K B; Harper, M T; Raines, C R

    2010-06-01

    A field study was conducted to record observations of 41,744 market-weight pigs upon arrival at a commercial abattoir to evaluate the relationships between various independent factors and open-mouth breathing, skin discoloration, lameness, unloading time, and mortality during transport. Observations were recorded from 242 trailer loads on 46 separate days over a period of 14 mo. Travel time (or=2.5 h), wait time before unloading (or=20 min), loading pressure (space or >or=260 kg of BW/m(2) trailer floor space), ambient temperature while unloading (or=17 degrees C), and trailer type [potbelly (PB); straight-deck with conventional unloading doors (SDC); or straight-deck with wide unloading doors (SDW)] were recorded for each load. Open-mouth breathing was more prevalent in pigs when transported on PB trailers compared with that of SDC or SDW trailers (P or=17 degrees C, P or=17 degrees C. Lameness was more prevalent (P travel times at greater loading pressure compared with shorter travel times at decreased loading pressure. Unloading time for PB trailers was longer (P 0.10) relationships between mortality and any independent variable tested. Wait time before unloading was not associated (P > 0.10) with any of the dependent variables included in the statistical model. In conclusion, warmer ambient temperatures (>or=17 degrees C) and the use of PB trailers are associated with an increased incidence of open-mouth breathing and skin discoloration, and longer unloading times after the transport of market pigs.

  11. Effectiveness and tolerability of parenteral testosterone undecanoate: a post-marketing surveillance study.

    Science.gov (United States)

    Wolf, Jan; Keipert, Dieter; Motazedi, Heiko; Ernst, Michael; Nettleship, Joanne; Gooren, Louis

    2017-12-01

    This observational post-marketing study of parenteral testosterone undecanoate (TU) in a non-selected population aimed to: examine the effectiveness of TU as treatment of hypogonadism; record adverse drug reactions (ADR) quantitatively particularly regarding polycythemia, prostate safety and cardiovascular-related metabolic risk factors; and verify whether recommended injection intervals apply to routine clinical practice. Eight hundred and seventy subjects from 259 outpatient units scheduled to visit the clinic six times were included. Effectiveness and tolerability of TU administration were assessed on a 4-point scale. Body weight, waist girth, blood pressure, hemoglobin levels, hematocrit, prostate-specific antigen (PSA), and digital rectal prostate examination were assessed. Over 90% of subjects completed the observational duration of 52.8 ± 9.7 weeks (mean ± SD) and 56% judged effectiveness as very good, 30.8% as good. 63.1% judged tolerability as very good, and 24.4% as good. No adverse effects on indicators of cardiovascular risk were observed. Polycythemia occurred in one subject and a supranormal hematocrit in one subject. Four subjects developed supranormal PSA levels. Prostate carcinoma was found in one subject, one subject had recurrence of a previously surgically treated prostate carcinoma, and the other two showed no indication of malignancy. Parenteral TU is safe, effective, and well-tolerated in clinical practice proving a good therapeutic option for hypogonadism.

  12. Revisiting Stock Market Integration Pre-Post Subprime Mortgage Crisis: Insight From BRIC Countries

    Directory of Open Access Journals (Sweden)

    Chin-Hong Puah

    2015-07-01

    Full Text Available This study revisits the long-run relationships and short-run dynamic causal linkages among BRIC stock market, with the particular attention to the 2008 subprime mortgage crisis. Extending related empirical studies, comparative analyses of pre-crisis, and post-crisis periods were conducted to comprehensively evaluate how stock market integration was affected by financial crises. In general, after employing cointegration test and VAR test, the results reveal the increase of stock market integration in BRICs after the subprime crisis. The evidence also found that China stock market is the most influential among the BRICs, in which China stock market has the ability to Granger cause the other three BRICs member countries. An important implication of our findings is that the degree of integration among countries tends to change over time, especially around periods marked by financial crises.

  13. Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.

    Science.gov (United States)

    Mori, Jinichi; Tanimoto, Tetsuya; Miura, Yuji; Kami, Masahiro

    2015-06-01

    All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  14. Empirical observations of bidding patterns in Australia's National Electricity Market

    International Nuclear Information System (INIS)

    Hu Xinmin; Grozev, George; Batten, David

    2005-01-01

    For more than a decade, electricity industries have been undergoing reform worldwide. However, there are various, sometimes contradictory, conclusions about the performance of these restructured electricity markets. Market performance depends largely on how each market participant responds to the market design -- including market rules, market operational procedures, and information revelation. In this paper, we identify and examine the strategies adopted by generators in Australia's National Electricity Market, based on publicly available data for the period from May 1, 2002 to May 31, 2003. We try to understand and answer some basic questions like how generators respond collectively or individually to changes in market conditions (e.g. load changes) and why they behave in this way. The statistics calculated from the data show that wide variations in the frequency of strategic bidding and rebidding exist; that generators more frequently use capacity offers as a strategic tool than price offers; that large generating units are more likely to use capacity strategies to control market prices; and that generators are capable of responding to changes in market conditions

  15. Empirical observations of bidding patterns in Australia's National Electricity Market

    International Nuclear Information System (INIS)

    Xinmin Hu; Grozev, G.; Batten, D.

    2005-01-01

    For more than a decade, electricity industries have been undergoing reform worldwide. However, there are various, sometimes contradictory, conclusions about the performance of these restructured electricity markets. Market performance depends largely on how each market participant responds to the market design - including market rules, market operational procedures, and information revelation. In this paper, we identify and examine the strategies adopted by generators in Australia's National Electricity Market, based on publicly available data for the period from May 1, 2002 to May 31, 2003. We try to understand and answer some basic questions like how generators respond collectively or individually to changes in market conditions (e.g. load changes) and why they behave in this way. The statistics calculated from the data show that wide variations in the frequency of strategic bidding and rebidding exist; that generators more frequently use capacity offers as a strategic tool than price offers; that large generating units are more likely to use capacity strategies to control market prices; and that generators are capable of responding to changes in market conditions. (author)

  16. The Visible Hand: Markets, Politics, and Regulation in Post-Katrina New Orleans

    Science.gov (United States)

    Jabbar, Huriya

    2016-01-01

    In this article Huriya Jabbar examines how the regulatory environment in post-Hurricane Katrina New Orleans has influenced choice, incentives, and competition among schools. While previous research has highlighted the mechanisms of competition and individual choice--the "invisible hand"--and the creation of markets in education, Jabbar…

  17. [Post-marketing drug safety-risk management plan(RMP)].

    Science.gov (United States)

    Ezaki, Asami; Hori, Akiko

    2013-03-01

    The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

  18. [Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Fu, Yingkun; Xie, Yanming

    2011-10-01

    In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.

  19. Do societal values influence financial development? : New evidence on the effects of post materialism and institutions on stock markets

    NARCIS (Netherlands)

    Jordaan, J.A.; Dima, Dogdan; Goleț, Ionuț

    2016-01-01

    In this paper we present new evidence on the effects of social values on stock market development. Using panel data for a heterogeneous set of 43 countries, we use the Inglehart post materialism index to identify the relation between the degree of post materialism and the size of stock markets.

  20. [Strategy of constructing post-market integral evaluation system of traditional Chinese medicine injection].

    Science.gov (United States)

    Zhang, Xiao-Yu; Wang, Yan-Ping; Lin, Li-Kai; Shang, Hong-Cai; Wang, Yong-Yan

    2017-08-01

    As an important representative of modern Chinese medicine, traditional Chinese medicine (TCM) injzection has become an indispensable part of the Chinese medicine industry. However, its development is now restricted by the bottleneck of insufficient core competitiveness, low-level research and production, even injection quality and the safe use are not guaranteed. Thus, it is urgent to reevaluate post-marketing TCM injection generally and to make secondary development. Under current circumstances, taking major brands which have good clinical and market foundation, as well as research value, as the main subject of cultivation and evaluation is an important approach to innovative development of TCM injection industry. Unlike oral proprietary Chinese medicine, the cultivatation of major brands of TCM injection needs higher technical support, quality standards and more timely feedback. Therefore, a post-market integral evaluation system adaptive to TCM injection is required. This article discussed some key points on the construction of a post-market integral evaluation system of TCM injection in three levels: optimizing evaluation methods, building synergistic innovation platforms which combine the medical research institutions and pharmaceutical enterprises, and finally constructing the integral evaluation system. A "five to one" structure has been proposed to enhance TCM injection effectiveness, safety and adaptability on the whole, which are from the following aspects: mechanism research, clinical evidence validation, literature information mining, sustainable development of resources and industrialization operation. Copyright© by the Chinese Pharmaceutical Association.

  1. Post-marketing surveillance of OraQuick whole blood and oral fluid rapid HIV testing.

    Science.gov (United States)

    Wesolowski, Laura G; MacKellar, Duncan A; Facente, Shelley N; Dowling, Teri; Ethridge, Steven F; Zhu, Julia H; Sullivan, Patrick S

    2006-08-01

    Post-marketing surveillance was conducted to monitor the performance of the OraQuick Advance rapid HIV-1/2 antibody test (OraQuick) on whole blood and oral fluid. Surveillance of routinely collected data on clients tested with OraQuick in 368 testing sites affiliated with 17 state and city health departments between 11 August 2004 and 30 June 2005. For whole blood and oral fluid, we report the median (range) health department OraQuick specificity and positive predictive value (PPV), and the number of clients with discordant results (e.g. who had a reactive rapid test not confirmed positive by Western blot or indirect immunofluorescence). At one site with lower than expected oral-fluid specificity, we evaluated whether device expiration, manufacturing lot, operator practices, or device-storage or testing-area temperatures were associated with false-positive tests. During the surveillance period, 135 724 whole blood and 26 066 oral fluid rapid tests were conducted. The median health department whole blood OraQuick specificity was 99.98% (range: 99.73-100%) and PPV was 99.24% (range: 66.67-100%); the median oral fluid specificity was 99.89% (range: 99.44-100%) and PPV was 90.00% (range: 50.00-100%). A total of 124 discordant results were reported from 68 (0.05%) whole blood and 56 (0.22%) oral fluid rapid tests. The oral fluid specificity at the site with excess oral fluid false-positive tests was 98.7% (95% confidence interval: 98.18-99.11%). The increase in false-positive tests at that site was not associated with any specific device characteristic, operator procedure or temperature condition. The specificity of OraQuick performed on whole blood and oral fluid during post-marketing surveillance was compatible with the manufacturer's claim within the package insert. However, one site experienced lower than expected oral fluid specificity. Sites that observe that the specificity of OraQuick is lower than the range indicated in the package insert should notify the

  2. The Exempt Market in Canada: Empirics, Observations and Recommendations

    Directory of Open Access Journals (Sweden)

    Vijay Jog

    2015-03-01

    Full Text Available There is a massive and vital capital market at work in Canada — possibly bigger than rough estimates have so far suggested — and it is one for which several market regulators are preparing new rules. Yet the remarkable thing is how little we know about it. Data about the so-called exempt market are so lacking that were regulators in Ontario and the other provinces contemplating new exempt-market regulations to proceed, they would be creating policies based on anecdotal, incomplete and, potentially, incorrect evidence. Even estimating the size of the Canadian exempt market has been an inexact science, given the incomplete data, but we can estimate that it provides in excess of $100 billion in gross capital flow every year, and that amount continues to grow. While it may be natural to assume that the exempt market is used primarily by small and medium-sized enterprises, it seems it is primarily used by the financial services industry. These institutions appear to rely on the exempt market to raise potentially short-term debt capital relatively free of particularly burdensome information-disclosure requirements. Unfortunately, we are forced to rely here again on deductions based on limited evidence: So incomplete are the data about the exempt market that we lack even complete information on the type of issuers, investors and securities, or the volume and duration of the securities and the level of redemptions. The exempt market exists for important reasons: it is a way out of the regulatory conundrum, wherein the regulator’s mandate to protect investors, through significant requirements for information disclosure, can put too large a burden on certain issuers. That is why it is essential that any new regulations are developed using a thorough understanding of how it operates. Yet the reality is that it is impossible to evaluate how individual investors and small firms are using the exempt market, or their experience in it. This is

  3. Clinical outcomes with daptomycin: a post-marketing, real-world evaluation.

    Science.gov (United States)

    Sakoulas, G

    2009-12-01

    The Cubicin Outcomes Registry and Experience (CORE) is an ongoing, retrospective, post-marketing database of daptomycin use in the USA. Although non-comparative, CORE offers insight into real-life clinical experience with daptomycin in various Gram-positive infections and specific patient types. Analyses of daptomycin treatment outcomes using the CORE database revealed that treatment with daptomycin has resulted in high rates of clinical success for a variety of Gram-positive infections, including indicated infections such as complicated skin and soft tissue infections, Staphylococcus aureus bacteraemia and right-sided infective endocarditis, and non-indicated infections such as osteomyelitis. Treatment outcomes did not differ significantly according to the causative pathogen for any of the analyses performed and were not influenced by the vancomycin MIC. Patients frequently received therapy with alternative antibiotics prior to treatment with daptomycin, particularly those patients with more serious infections. However, similar treatment outcomes were observed when daptomycin was used as first-line therapy or as salvage therapy, demonstrating the effectiveness of daptomycin in the treatment of these patients.

  4. [The role of drug registries in the post-marketing surveillance].

    Science.gov (United States)

    Traversa, Giuseppe; Sagliocca, Luciano; Magrini, Nicola; Venegoni, Mauro

    2013-06-01

    The aim of this article is to provide an introduction to issue of Recenti Progressi in Medicina, devoted to the role of drug registries in the post-marketing surveillance. We first motivate the need to implement registries as a tool in promoting the appropriateness of drug use and acquiring additional information on the risk-benefit profile of drugs. Then, the different role that can be played by registries in comparison with prescription monitoring systems and observational studies is clarified. The presentation of some of the most relevant registries established in Italy since the end of the '90s, with the analysis of their strengths and weaknesses, helps to understand some of the crucial issues that should be taken into account before a new registry is adopted. Specifically, we deal with the relationship between objectives - of appropriateness, effectiveness and safety - and methods; the overlapping between drug-based registries and disease-based ones; the duration and extension of data collection, which may be either exhaustive or based on a sampling frame; the importance of ensuring the quality of the data and to minimize the number of subjects who are lost to follow-up; the importance of infrastructures, and of ad hoc funding, for the functioning of a registry; the independence in data analysis and publication of findings.

  5. A post-marketing study of gadodiamide hydrate in patients with cerebral infarction

    International Nuclear Information System (INIS)

    Ono, Yuko; Aoki, Shigeki

    2003-01-01

    We evaluated the efficacy and safety of gadodiamide hydrate (GH: Omuniscan) in patients with cerebral infarction in a multicenter post-marketing study. A total of 122 patients enrolled in this study at 16 institutions in throughout Japan. We administrated GH to patients intravenously at 0.2 mL/kg, an approved usage and dosage for head MRI. Efficacy was evaluated by comparing contrast intensity and diagnostic improvement on T1WI before and after the administration of GH and diagnostic significance was investigated. Moreover, clinical data thus obtained were compared with those of phase III studies of GH and other contrast agents with respect to general evaluation of diagnostic improvement. The effects of contrast enhancement on the detection and extent of lesions as well as image quality were judged in terms of improving general evaluation and diagnosis, which was observed in 93.3% of the patients. No serious adverse event were associated with GH administration. The efficacy of GH in this clinical trial was higher, than historical data, with respect to general evaluation and diagnostic improvement. Contrast enhanced MRI with GH in cerebral infarction was confirmed to be of diagnostic value. (author)

  6. Comparison of Group-Buying Online Auction and Posted Pricing Mechanism in an Uncertain Market

    Institute of Scientific and Technical Information of China (English)

    CHEN Jian; LIU Yunhui; SONG Xiping

    2004-01-01

    Demand uncertainty is a key factor for the seller's decision making, especially in the e-business environment, for the website to sell products through the online auction. In this paper, two kinds of demand uncertainties are considered: the consumer regime uncertainty and the inherent randomness of the market environment. Then, how to use a novel business model and group-buying auction (GBA) is analyzed in such a market environment. Based on the comparison of the GBA and the posted price mechanism, some conditions that favor the GBA are provided.

  7. The Impact of Active Labour Market Policy on Post-Unemployment Outcomes

    DEFF Research Database (Denmark)

    Blasco, Sylvie; Rosholm, Michael

    While job search theory predicts that active labour market policies (ALMPs) can affect post-unemployment outcomes, empirical evaluations investigating transition rates have mostly focused on the impact of ALMPs on exit rates from the current unemployment spell. We use a social experiment, which w......, the positive impact of the treatment becomes smaller but remains significant. 80% of the global impact of intensification acts through the direct channel for men.......While job search theory predicts that active labour market policies (ALMPs) can affect post-unemployment outcomes, empirical evaluations investigating transition rates have mostly focused on the impact of ALMPs on exit rates from the current unemployment spell. We use a social experiment, which...... was conducted in Denmark in 2005-6, to investigate the effects of a dramatic intensification of ALMPs on reemployment stability. We investigate the nature of this impact. We estimate a duration model with lagged duration dependence to separately identify "indirect" (via shorter unemployment duration...

  8. How to establish precise proprietary Chinese medicine in post-marketing reappraisal?

    Directory of Open Access Journals (Sweden)

    Ran Tian

    2017-10-01

    Full Text Available The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern. The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine. In this paper, we propose a reappraisal protocol called “precise proprietary Chinese medicine” to precisely i define the therapeutic aim; ii design the protocol; iii control the quality of proprietary Chinese medicine; iv implement the protocol in the trial; v study the mechanism-of-action of the proprietary Chinese medicine and vi describe the indications of the proprietary Chinese medicine. We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.

  9. [Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Du, Xiao-Xi; Song, Hai-Bo; Ren, Jing-Tian; Yang, Le; Guo, Xiao-Xin; Pang, Yu

    2014-09-01

    Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.

  10. [Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

    Science.gov (United States)

    Liu, Huan; Xie, Yanming

    2011-10-01

    The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

  11. Mars MetNet Mission - Martian Atmospheric Observational Post Network

    Science.gov (United States)

    Hari, Ari-Matti; Haukka, Harri; Aleksashkin, Sergey; Arruego, Ignacio; Schmidt, Walter; Genzer, Maria; Vazquez, Luis; Siikonen, Timo; Palin, Matti

    2017-04-01

    accelerometer combined with a 3-axis gyrometer. The data will be sent via auxiliary beacon antenna throughout the descent phase starting shortly after separation from the spacecraft. MetNet Mission payload instruments are specially designed to operate under very low power conditions. MNL flexible solar panels provides a total of approximately 0.7-0.8 W of electric power during the daylight time. As the provided power output is insufficient to operate all instruments simultaneously they are activated sequentially according to a specially designed cyclogram table which adapts itself to the different environmental constraints. 3. Mission Status he eventual goal is to create a network of atmospheric observational posts around the Martian surface. Even if the MetNet mission is focused on the atmospheric science, the mission payload will also include additional kinds of geophysical instrumentation. The next step is the MetNet Precursor Mission that will demonstrate the technical robustness and scientific capabilities of the MetNet type of landing vehicle. Definition of the Precursor Mission and discussions on launch opportunities are currently under way. The first MetNet Science Payload Precursors have already been successfully completed, e,g, the REMS/MSL and DREAMS/Exomars-2016. The next MetNet Payload Precursors will be METEO/Exomars-2018 and MEDA/Mars-2020. The baseline program development funding exists for the next seven years. Flight unit manufacture of the payload bay takes about 18 months, and it will be commenced after the Precursor Mission has been defined. References [1] http://metnet.fmi.fi

  12. Estimating post-marketing exposure to pharmaceutical products using ex-factory distribution data.

    Science.gov (United States)

    Telfair, Tamara; Mohan, Aparna K; Shahani, Shalini; Klincewicz, Stephen; Atsma, Willem Jan; Thomas, Adrian; Fife, Daniel

    2006-10-01

    The pharmaceutical industry has an obligation to identify adverse reactions to drug products during all phases of drug development, including the post-marketing period. Estimates of population exposure to pharmaceutical products are important to the post-marketing surveillance of drugs, and provide a context for assessing the various risks and benefits, including drug safety, associated with drug treatment. This paper describes a systematic approach to estimating post-marketing drug exposure using ex-factory shipment data to estimate the quantity of medication available, and dosage information (stratified by indication or other factors as appropriate) to convert the quantity of medication to person time of exposure. Unlike the non-standardized methods often used to estimate exposure, this approach provides estimates whose calculations are explicit, documented, and consistent across products and over time. The methods can readily be carried out by an individual or small group specializing in this function, and lend themselves to automation. The present estimation approach is practical and relatively uncomplicated to implement. We believe it is a useful innovation. Copyright 2006 John Wiley & Sons, Ltd.

  13. Post-processing of high-contrast observations of exoplanets

    Directory of Open Access Journals (Sweden)

    Gladysz S.

    2011-07-01

    Full Text Available Post-processing of images delivered by the eXtreme Adaptive Optics (XAO instrumentation is a crucial step which can increase achievable contrast even by two orders of magnitude. In this communication I present a new class of algorithms for detection of extrasolar planets from a sequence of adaptive-optics-corrected images. In general, the methods discriminate between real sources and stellar PSF features based on statistics of recorded intensity. The methods are particularly useful in dealing with static speckles which are the greatest obstacle in detecting exoplanets.

  14. Decoupling the Oil and Gas Prices. Natural Gas Pricing in the Post-Financial Crisis Market

    International Nuclear Information System (INIS)

    Kanai, Miharu

    2011-01-01

    This paper looks into natural gas pricing in the post-financial crisis market and, in particular, examines the question whether the oil-linked gas pricing system has outlived its utility as global gas markets mature and converge more rapidly than expected and as large new resources of unconventional gas shift the gas terms-of-trade. Two opposing natural gas pricing systems have coexisted for the last two decades. On the one hand, there is traditional oil-linked pricing, used in pipeline gas imports by Continental European countries and in LNG imports by the countries in Far East. The other is the system led by futures exchanges in deregulated, competitive markets largely in the UK and the US. World gas markets are changing and the basis and mechanisms of price formation are changing with them. There is no reason to expect a revolution in gas pricing, but formulas designed to address the challenges of the 1970's will need to adjust to the realities of the present and expectations for the 21. century. Because such changes will imply a redistribution of costs and benefits, vested shareholders will defend the status quo. But hopefully and ultimately, appropriately regulated markets will assert themselves and shareholders along the entire value chain will have their interests served

  15. Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis.

    Science.gov (United States)

    Cohen, Stanley; Curtis, Jeffrey R; DeMasi, Ryan; Chen, Yan; Fan, Haiyun; Soonasra, Arif; Fleischmann, Roy

    2018-06-01

    Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting. Worldwide tofacitinib PMS data received in the Pfizer safety database from November 6, 2012 (first marketing authorization of tofacitinib) to November 5, 2015 were analyzed. Serious AEs (SAEs) of interest were reviewed and reporting rates (RRs) were calculated by dividing the number of SAEs by the estimated 100 patient-years of exposure. Patient exposure was calculated based on estimated worldwide sales and an estimated daily regimen of tofacitinib 5 mg twice daily. During the 3-year reporting period, worldwide post-marketing exposure to tofacitinib since approval was estimated to be 34,223 patient-years. In total, 9291 case reports (82.9% non-serious) were received and 25,417 AEs, 102 fatal cases, and 4352 SAEs were reported. The RRs (per 100 patient-years) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 2.57 for infections, 0.91 for gastrointestinal disorders, 0.60 for respiratory disorders, 0.45 for neoplasms, 0.43 for cardiac disorders, and 0.12 for hepatobiliary disorders. Although there are limitations to these data, no new safety risks were revealed in this real-world setting compared with the safety profile identified in the tofacitinib RA clinical development program. Any risks identified through the tofacitinib development program and PMS will continue to be monitored through pharmacovigilance surveillance. Pfizer Inc.

  16. Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

    Science.gov (United States)

    Silva, Ivair R

    2018-01-15

    Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post-market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis. Copyright © 2017 John Wiley & Sons, Ltd.

  17. [Expert consensus post-marketing evaluation scheme to detect immunotoxicity of Chinese medicine in clinical populations (draft version for comments)].

    Science.gov (United States)

    Xie, Yan-Ming; Zhao, Yu-Bin; Jiang, Jun-Jie; Chang, Yan-Peng; Zhang, Wen; Shen, Hao; Lu, Peng-Fei

    2013-09-01

    Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.

  18. 76 FR 41238 - Post Rock Wind Power Project, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2011-07-13

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER11-3959-000] Post Rock Wind Power Project, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for... Rock Wind Power Project, LLC's application for market-based rate authority, with an accompanying rate...

  19. A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

    Science.gov (United States)

    Velentgas, Priscilla; Bohn, Rhonda L; Brown, Jeffrey S; Chan, K Arnold; Gladowski, Patricia; Holick, Crystal N; Kramer, Judith M; Nakasato, Cynthia; Spettell, Claire M; Walker, Alexander M; Zhang, Fang; Platt, Richard

    2008-12-01

    We describe a multi-center post-marketing safety study that uses distributed data methods to minimize the need for covered entities to share protected health information (PHI). Implementation has addressed several issues relevant to creation of a large scale post-marketing drug safety surveillance system envisioned by the FDA's Sentinel Initiative. This retrospective cohort study of Guillain-Barré syndrome (GBS) following meningococcal conjugate vaccination incorporates the data and analytic expertise of five research organizations closely affiliated with US health insurers. The study uses administrative claims data, plus review of full text medical records to adjudicate the status of individuals with a diagnosis code for GBS (ICD9 357.0). A distributed network approach is used to create the analysis files and to perform most aspects of the analysis, allowing nearly all of the data to remain behind institutional firewalls. Pooled analysis files transferred to a central site will contain one record per person for approximately 0.2% of the study population, and contain PHI limited to the month and year of GBS onset for cases or the index date for matched controls. The first planned data extraction identified over 9 million eligible adolescents in the target age range of 11-21 years. They contributed an average of 14 months of eligible time on study over 27 months of calendar time. MCV4 vaccination coverage levels exceeded 20% among 17-18-year olds and 16% among 11-13 and 14-16-year-old age groups by the second quarter of 2007. This study demonstrates the feasibility of using a distributed data network approach to perform large scale post-marketing safety analyses and is scalable to include additional organizations and data sources. We believe these results can inform the development of a large national surveillance system. Copyright (c) 2008 John Wiley & Sons, Ltd.

  20. Impact of Insurance Market on Economic Growth in Post-Transition Countries

    Directory of Open Access Journals (Sweden)

    Phutkaradze Jaba

    2014-12-01

    Full Text Available The purpose of this work is to identify whether the development of an insurance market is linked to economic growth in former transition countries. A multiple regression analysis is employed to estimate the insurance-growth relationship, using a cross-country panel dataset analysis tracking annual total insurance penetration in 10 countries over the 2000-2012 period, and applying a fixed effect model to test the hypothesis that this linkage is demonstrably positive. The results show a negative and statistically non-significant correlation between insurance and GDP growth, suggesting a lack of evidence that insurance promotes economic growth in post-transition economies.

  1. [Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection].

    Science.gov (United States)

    Li, Xuelin; Tang, Jinfa; Meng, Fei; Li, Chunxiao; Xie, Yanming

    2011-10-01

    To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection. Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis. Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions. The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.

  2. Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic.

    Science.gov (United States)

    Stollenwerk, Ariane; Sohns, Melanie; Heisig, Fabian; Elling, Christian; von Zabern, Detlef

    2018-01-01

    Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009. This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials. The first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses. More than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population. Grünenthal GmbH.

  3. [Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

    Science.gov (United States)

    Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

    2015-09-01

    The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

  4. Pediatric post-marketing safety systems in North America: assessment of the current status.

    Science.gov (United States)

    McMahon, Ann W; Wharton, Gerold T; Bonnel, Renan; DeCelle, Mary; Swank, Kimberley; Testoni, Daniela; Cope, Judith U; Smith, Phillip Brian; Wu, Eileen; Murphy, Mary Dianne

    2015-08-01

    It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use. We reviewed North American pediatric post-marketing safety systems such as databases, networks, and research consortiums found in peer-reviewed journals and other online sources. We detail clinical examples from three systems that FDA used to assess pediatric medical product safety. Of the 59 systems reviewed for pediatric content, only nine were pediatric-focused and met the inclusion criteria. Brief descriptions are provided for these nine. The strengths and weaknesses of three systems (two of the nine pediatric-focused and one including both children and adults) are illustrated with clinical examples. Systems reviewed in this manuscript have strengths such as clinical detail, a large enough sample size to capture rare adverse events, and/or a patient denominator internal to the database. Few systems include all of these attributes. Pediatric drug safety would be better informed by utilizing multiple systems to take advantage of their individual characteristics. Copyright © 2015 John Wiley & Sons, Ltd.

  5. Sample size for post-marketing safety studies based on historical controls.

    Science.gov (United States)

    Wu, Yu-te; Makuch, Robert W

    2010-08-01

    As part of a drug's entire life cycle, post-marketing studies are an important part in the identification of rare, serious adverse events. Recently, the US Food and Drug Administration (FDA) has begun to implement new post-marketing safety mandates as a consequence of increased emphasis on safety. The purpose of this research is to provide exact sample size formula for the proposed hybrid design, based on a two-group cohort study with incorporation of historical external data. Exact sample size formula based on the Poisson distribution is developed, because the detection of rare events is our outcome of interest. Performance of exact method is compared to its approximate large-sample theory counterpart. The proposed hybrid design requires a smaller sample size compared to the standard, two-group prospective study design. In addition, the exact method reduces the number of subjects required in the treatment group by up to 30% compared to the approximate method for the study scenarios examined. The proposed hybrid design satisfies the advantages and rationale of the two-group design with smaller sample sizes generally required. 2010 John Wiley & Sons, Ltd.

  6. [Establishment of model of traditional Chinese medicine injections post-marketing safety monitoring].

    Science.gov (United States)

    Guo, Xin-E; Zhao, Yu-Bin; Xie, Yan-Ming; Zhao, Li-Cai; Li, Yan-Feng; Hao, Zhe

    2013-09-01

    To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections (TCMIs). A TCMIs safety monitoring team and a research hospital team engaged in the research, monitoring processes, and quality control processes were established, in order to achieve comprehensive, timely, accurate and real-time access to research data, to eliminate errors in data collection. A triage system involving a study nurse, as the first point of contact, clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero. A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model, ensures that research data collected has the characteristics of authenticity, accuracy, timeliness, integrity, and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.

  7. Condom social marketing program to prevent HIV/AIDS in post-conflict Liberia.

    Science.gov (United States)

    Harris, A O; Jubwe, S; Kennedy, S B; Taylor, C H; Martin, R B; Bee, E M; Perry, O S; Massaquoi, M T; Woods, D V; Barbu, E M

    2011-08-01

    Youths in sub-Saharan Africa (SSA) account for a large burden of the global HIV/STI crises. As such, strategies directed at promoting behavioral modifications would be critical to reducing the prevalence of risky sexual behaviors among high risk adolescents in post-conflict environments. This study describes a condom promotion strategy to prevent HIV/STIs among highly vulnerable urban youth in a post-conflict, resource-constrained environment via the provision of both male and female condoms to nontraditional venues like music and photo shops, ice cream parlors, money exchange centers and beauty salons. Community members in the designated catchment areas volunteered their services and the use of their small businesses to support this endeavor. In this paper, we describe the condom promotion strategy and its implications within the context of a community-based participatory social marketing program to prevent risky sexual behaviors among highly vulnerable urban youth in a post-conflict country. We postulate that this approach may likely increase condom use among urban youth in Monrovia, the capital city of Liberia.

  8. Safety and Effectiveness of Mirabegron in Patients with Overactive Bladder Aged ≥75 Years: Analysis of a Japanese Post-Marketing Study.

    Science.gov (United States)

    Yoshida, Masaki; Nozawa, Yumiko; Kato, Daisuke; Tabuchi, Hiromi; Kuroishi, Kentarou

    2017-09-12

    A 12-week post-marketing study was conducted to provide real-world data on Japanese patients with overactive bladder (OAB) initiating treatment with mirabegron. This post-hoc analysis focused on safety and effectiveness of mirabegron in patients aged ≥75 versus Similar changes were observed for I-PSS QoL in both groups. In a real-world clinical setting, mirabegron was well-tolerated and effective in patients aged ≥75 and <75 years. © 2017 John Wiley & Sons Australia, Ltd.

  9. Safety and Effectiveness of Natalizumab: First Report of Interim Results of Post-Marketing Surveillance in Japan.

    Science.gov (United States)

    Saida, Takahiko; Yokoyama, Kazumasa; Sato, Ryusuke; Makioka, Haruki; Iizuka, Yukihiko; Hase, Masakazu; Ling, Yan; Torii, Shinichi

    2017-12-01

    Natalizumab, a humanized anti-α4 integrin monoclonal antibody, received marketing approval in Japan in 2014 for the treatment of multiple sclerosis (MS). Because the previous large-scale clinical trials of natalizumab were mainly conducted in Europe and North American countries, and data in patients with MS from Japan were limited, we conducted an all-case post-marketing surveillance of natalizumab-treated MS patients from Japan to investigate the safety and effectiveness of natalizumab in a real-world clinical setting in Japan. Here, we report the results of an interim analysis. During the observation period of 2 years, all patients who were treated with natalizumab subsequent to its approval in Japan were followed. The effectiveness of natalizumab was assessed by examining the changes in expanded disability status scale (EDSS) score and annualized relapse rate (ARR) from baseline. Safety was assessed by analyzing the incidence of adverse drug reactions (ADRs). The safety analysis included 106 patients (mean age 39.3 years; women 62.3%) whose data were collected until the data lock point (February 7, 2016). The effectiveness analysis included 75 patients. The majority of patients had relapsing-remitting MS (93/106 patients; 87.7%). The mean length of treatment exposure in the present study was 6.6 months. During the 2-year observation period, no significant change in the EDSS was observed, while the ARR decreased significantly from baseline (72.9% reduction, p = 0.001). ADRs and serious ADRs were observed in 11.3% and 3.8% of patients, respectively; however, no new safety concerns were detected. No patient had progressive multifocal leukoencephalopathy (PML) during the present study period. The safety and effectiveness of natalizumab were confirmed in Japanese patients with MS in clinical practice. Nevertheless, potential risks including PML require continuous, careful observation. Biogen Japan Ltd (Tokyo, Japan).

  10. Evaluating Observational Learning in a Competitive Two-Sided Crowdsourcing Market: A Bayesian Inferential Approach

    Science.gov (United States)

    Ayaburi, Emmanuel Wusuhon Yanibo

    2017-01-01

    This dissertation investigates the effect of observational learning in crowdsourcing markets as a lens to identify appropriate mechanism(s) for sustaining this increasingly popular business model. Observational learning occurs when crowdsourcing participating agents obtain knowledge from signals they observe in the marketplace and incorporate such…

  11. Use of carabids for the post-market environmental monitoring of genetically modified crops

    Czech Academy of Sciences Publication Activity Database

    Skoková Habuštová, Oxana; Svobodová, Zdeňka; Cagáň, Ľ.; Sehnal, František

    2017-01-01

    Roč. 9, č. 4 (2017), č. článku 121. E-ISSN 2072-6651 R&D Projects: GA MŠk(CZ) 7AMB14SK096 Grant - others:projekt VEGA(SK) 1/0732/14; GA ČR(CZ) L200961652 Institutional support: RVO:60077344 Keywords : Carabidae * surrogate * post-market environmental monitoring Subject RIV: GF - Plant Pathology, Vermin, Weed, Plant Protection OBOR OECD: GM technology (crops and livestock), livestock cloning, marker assisted selection, diagnostics (DNA chips and biosensing devices for the early/accurate detection of diseases) biomass feedstock production technologies, biopharming Impact factor: 3.030, year: 2016 http://www.mdpi.com/2072-6651/9/4/121

  12. Decision support methods for the detection of adverse events in post-marketing data.

    Science.gov (United States)

    Hauben, M; Bate, A

    2009-04-01

    Spontaneous reporting is a crucial component of post-marketing drug safety surveillance despite its significant limitations. The size and complexity of some spontaneous reporting system databases represent a challenge for drug safety professionals who traditionally have relied heavily on the scientific and clinical acumen of the prepared mind. Computer algorithms that calculate statistical measures of reporting frequency for huge numbers of drug-event combinations are increasingly used to support pharamcovigilance analysts screening large spontaneous reporting system databases. After an overview of pharmacovigilance and spontaneous reporting systems, we discuss the theory and application of contemporary computer algorithms in regular use, those under development, and the practical considerations involved in the implementation of computer algorithms within a comprehensive and holistic drug safety signal detection program.

  13. [Research about re-evaluation of screening of traditonal Chinese medicine symptoms item of post-marketing medicine Xuezhikang].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The purpose of post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine(TCM) symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the accoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation.

  14. [Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

    Science.gov (United States)

    Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

    2013-11-01

    By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

  15. Safety and effectiveness of certolizumab pegol in patients with rheumatoid arthritis: Interim analysis of post-marketing surveillance.

    Science.gov (United States)

    Kameda, Hideto; Nishida, Keiichiro; Nannki, Toshihiro; Watanabe, Akira; Oshima, Yukiya; Momohara, Shigaki

    2017-01-01

    Objective: To evaluate the safety and effectiveness of certolizumab pegol (CZP) in a real-world setting among Japanese patients with rheumatoid arthritis. Post-marketing surveillance data from 2,579 patients treated with CZP were analyzed. Adverse events (AEs) observed during the 24-week CZP treatment period were recorded. Disease activity was evaluated using DAS28-ESR and DAS28-CRP at baseline, Week 12, Week 24, or at withdrawal. The total period of exposure to CZP was 1313.8 patient-years (PY). AEs were reported in 658 (25.5%) patients, at an event rate (ER) of 73.68/100 PY. The most frequent serious AEs were pneumonia, herpes zoster, and interstitial lung disease, at ER per 100 PY of 2.06, 1.29, and 1.22, respectively. Mean disease activity scores at baseline, as measured by DAS28-ESR and DAS28-CRP, were 4.77 ± 1.34 and 4.21 ± 1.27, respectively. Mean changes from baseline at the last observation were -1.29 ± 1.46 and -1.30 ± 1.42, respectively. EULAR good or moderate responses were achieved in 65% of patients. Longer disease duration, prior biologics use, and treatment without MTX co-therapy were associated with EULAR no response. In this interim analysis, no new safety signals were observed. Clinical response to CZP was observed in approximately two thirds of patients.

  16. National post-market surveillance assessment of veterinary medicines in Korea during the past decade.

    Science.gov (United States)

    Kang, JeongWoo; Park, Hae-Chul; Jang, Yang Ho; Hossain, Md Akil; Jeong, Kyunghun; Jeong, Mi Young; Yun, Seon-Jong; Park, Sung-Won; Kim, Dae Gyun; Lee, Kwang-Jick

    2017-05-22

    Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine. In this study, 1650 drugs for veterinary use were collected per year from each city and province in Korea and analysed for the quantity of active ingredients according to the "national post-market surveillance (NPMS) system" over the past decade. The NPMS assessment was performed using liquid and gas chromatography, titration, UV/Vis spectrophotometry, and bioassays. A total of 358 cases were deemed noncompliant, with the average noncompliance rate for all medicine types being 2.0%. The average noncompliance rates for antibiotics, biologics and other chemical drugs except antibiotics (OCD) were 1.1%, 1.2%, and 3.0%, respectively. The first leading cause for noncompliant products was insufficient quantity of major ingredients (283 cases), and the second leading cause was the existence of excess amount of active ingredients (60 cases). Tylosin, spiramycin, ampicillin, tetracyclines and penicillins were most frequently found to be noncompliant among antibiotics. Among the OCD, the noncompliance was found commonly in vitamin A. The overall trend presented gradually decreasing violation rates, suggesting that the quality of veterinary medicines has improved. Consistent application of the NPMS assessment and the establishment of the Korea Veterinary Good Manufacturing Practice (KVGMP) will help to maintain the good

  17. Emerging Markets: Theory & Practice / Turkey’s Reforms Post 2001 Crisis

    Directory of Open Access Journals (Sweden)

    Duygu Uckun

    2010-01-01

    Full Text Available The global financial downturn of 2001 affected broad swaths of the increasingly interconnected global economy. The global effects of the economic downturn in the U.S. in 2008 showed that decoupling had not occurred to the extent many thought, and showed that indeed emerging market countries, including Turkey, were not immune from economic trouble in America. This paper addresses the question, whether the fiscal, financial, and regulatory reforms in Turkey after the 2001 economic crisis cushion the global financial crisis world is facing toward the end of the decade. In doing so we analyze the policies implemented by Turkey before and after the 2001 global economic crisis and identify the successes as well as failures of those reforms. The results of our research show that despite significant reforms in key economic and regulatory areas in the post-2001 crisis period, vulnerabilities remained; especially concerning the large current account deficit, volatility of exchange rates, increased private sector indebtedness, and persistent unemployment. These vulnerabilities will be visible in the deteriorating liquidity conditions in the global financial markets. We conclude by recommending infrastructure, education and health spending as well as restructuring of the economy to further attract FDI and avoid reliance on speculative foreign capital in order to achieve a more balanced and sustained growth in the long run.

  18. Incorporating Spirituality and Market: Islamic Sharia Business and Religious Life in Post-New Order Indonesia

    Directory of Open Access Journals (Sweden)

    Wildan Sena Utama

    2016-06-01

    Full Text Available 0 0 1 154 880 wildan 7 2 1032 14.0 Normal 0 false false false EN-US JA X-NONE Artikel ini membahas tentang transformasi religious kelas menengah Indonesia danhubungannya dengan pertumbuhan pasar syariah pada pasca-Orde Baru di Indonesia.Artikel ini berpendapat bahwa dalam era neoliberal Indonesia, kebangkitan spiritualini sangat memengaruhi ranah ekonomi. Transformasi kesalehan kelas menengahIndonesia menandai munculnya potensi pasar ekonomi baru. Hal itu direspon secaraantusias oleh pasar dengan memproduksi produk yang selektif berisi konten spiritual.Dalam prosesnya, peran para agen gaya hidup spiritual memainkan peranan pentingdalam membantu dan membentuk kelas menengah urban baru ini dalam mengonsumsiIslam untuk menandakan identitas keislaman mereka. Kemudian muncullah perpaduanaktif antara kesalehan Islam dan kapitalisme dalam situasi Indonesia kontemporer.Konsumsi simbolis Islam menjadi sumber baru dari spiritualisme maupun sumber dariidentifikasi religius. Akan tetapi, artikel ini berpendapat bahwa proses ini cenderungmenyederhanakan Islam sebagai ‘prosesi material’ daripada ‘prosesi spiritual’. This article examines the religious transformation of the Muslim middle class and itsrelationship with the growing sharia market in post-New Order Indonesia. It arguesthat in the Indonesian neo-liberal era, this spiritual revival considerably influenced theeconomic realm. The transformation of piety of the Indonesian middle class markedthe emergence of new potential economic markets. It was responded to enthusiasticallyby markets producing selective products with a spiritual content. In its process, therole of spiritual lifestyle agents played a pivotal role in helping and shaping the newurban middle class who consume Islam to mark their Islamic identity. It was then thatthe energetic blending between Islamic piety and capitalism occurred in contemporaryIndonesia. Islamic symbolic consumption becomes a new source of spiritualism as wellas

  19. [Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

    Science.gov (United States)

    Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

    2015-06-01

    The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

  20. Study on freshness quality and post-harvest loss of Hilsa (Tenualosa Ilisha during marketing in Mymensingh town, Bangladesh

    Directory of Open Access Journals (Sweden)

    Dilip Chandra Ray

    2015-08-01

    Full Text Available An investigation was conducted to know the freshness quality and associated post-harvest loss of hilsa, if any, transported to Mymensingh from the major landing centers through Cox’s Bazar-Chittagong (route A and Barguna-Chandpur (route B routes for a period of July to October 2012. The average environmental temperature of the wholesale and retail markets was 30.7 °C and 30.6 °C where the body temperature of hilsa was 4.5 °C (route A and 4.7 °C (route B, respectively. The Freshness quality of hilsa was assessed using sensory defects points (DPs that eventually gave rise to numerical values ‘1’ being the freshest and ‘5’ being the worst quality. The DPs of hilsa were found 2.0, which reveal that the fishes were in excellent conditions, i.e., there was no significant post-harvest loss even during retail sale. DPs on arrival and at wholesale in July, September and October were significantly different after auction and during retail sale (p<0.05, and in August differed significantly only during retail sale (p<0.05. It was observed that hilsa transported to Mymensingh from Barguna-Chandpur were better in quality than those transported from Cox’s Bazar-Chittagong. The reason behind this finding was not studied and this needs to be elucidated through further research.

  1. Financial Investment Management: Testing the Market Model on the Romanian Capital Market during the Post Financial Crisis

    Directory of Open Access Journals (Sweden)

    Radu CIOBANU

    2011-06-01

    Full Text Available This article presents an analysis of the decision of investing in the capital market in Romania during 2009-2010, in the context of overcoming the global financial crisis. In the first part of the paper, we have made a brief presentation of the simplified model of market analysis introduced in the specialized literature by William Sharpe, the respective model representing the starting point in our study. The purpose of the present study is to emphasize how the evolutions of the financial securities rates listed on the Bucharest Stock Exchange could be explained based on the evolution of BET Romanian capital market index. Although the study over this phenomenon has begun in the middle of the last century, every day new studies appear that are either coming in addition to the already existing ones or are bringing a new approach regarding the financial theory. The novelty of the present study conducted by us resides in the highlighting of the evolutions of the financial securities rates during July 2009 – December 2010 periods. The second part of the paper presents the results of a study conducted on the Romanian capital market, emphasizing the correlations between the most important securities on the Romanian capital market, as parts of BET index and market index. The aim is to check whether during this period the evolution of the financial securities’ return can be explained more or less by the return of the capital market.

  2. Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Industry

    Science.gov (United States)

    Wheelahan, Leesa; Buchanan, John; Yu, Serena

    2015-01-01

    This summary brings together the relevant key findings for industry from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between vocational education and training (VET) and…

  3. Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Qualification & Approval Bodies

    Science.gov (United States)

    Wheelahan, Leesa; Buchanan, John; Yu, Serena

    2015-01-01

    This summary pulls together the relevant key findings for qualification and approval bodies from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between vocational education…

  4. Economics and business administration post-graduates in transition from university to work: Labor market success factors

    NARCIS (Netherlands)

    Bijker, Monique; Van der Klink, Marcel; Boshuizen, Els

    2012-01-01

    Bijker, M. M., Van der Klink, M. R., & Boshuizen, H. P. A. (2012, 13-17 April). Economics and business administration post-graduates in transition from university to work: Labor market success factors. Paper presented at the Annual Meeting of the American Education Research Association (AERA),

  5. Mining association patterns of drug-interactions using post marketing FDA's spontaneous reporting data.

    Science.gov (United States)

    Ibrahim, Heba; Saad, Amr; Abdo, Amany; Sharaf Eldin, A

    2016-04-01

    Pharmacovigilance (PhV) is an important clinical activity with strong implications for population health and clinical research. The main goal of PhV is the timely detection of adverse drug events (ADEs) that are novel in their clinical nature, severity and/or frequency. Drug interactions (DI) pose an important problem in the development of new drugs and post marketing PhV that contribute to 6-30% of all unexpected ADEs. Therefore, the early detection of DI is vital. Spontaneous reporting systems (SRS) have served as the core data collection system for post marketing PhV since the 1960s. The main objective of our study was to particularly identify signals of DI from SRS. In addition, we are presenting an optimized tailored mining algorithm called "hybrid Apriori". The proposed algorithm is based on an optimized and modified association rule mining (ARM) approach. A hybrid Apriori algorithm has been applied to the SRS of the United States Food and Drug Administration's (U.S. FDA) adverse events reporting system (FAERS) in order to extract significant association patterns of drug interaction-adverse event (DIAE). We have assessed the resulting DIAEs qualitatively and quantitatively using two different triage features: a three-element taxonomy and three performance metrics. These features were applied on two random samples of 100 interacting and 100 non-interacting DIAE patterns. Additionally, we have employed logistic regression (LR) statistic method to quantify the magnitude and direction of interactions in order to test for confounding by co-medication in unknown interacting DIAE patterns. Hybrid Apriori extracted 2933 interacting DIAE patterns (including 1256 serious ones) and 530 non-interacting DIAE patterns. Referring to the current knowledge using four different reliable resources of DI, the results showed that the proposed method can extract signals of serious interacting DIAEs. Various association patterns could be identified based on the relationships among

  6. [Safety and efficacy of docetaxel in prostate cancer patients: based on the post-marketing surveillance in Japan].

    Science.gov (United States)

    Mera, Takeshi; Saijo, Nagahiro; Akaza, Hideyuki

    2012-04-01

    The safety and efficacy of docetaxel in prostate cancer were evaluated based on the results of post-marketing surveillance. 149 patients were enrolled between September 2008 and May 2010. The starting dose of docetaxel was 75 mg/m² in 53 patients(36%), 70 mg/m² in 55 (37%), and ≤ 60 mg/m² in 41(28%). The median number of treatment cycles was 8 (range, 1 to 10). There was no age difference observed in the starting doses and the treatment cycles. The most common ≥ grade 3 adverse drug reactions (ADRs) were neutropenia (71%)and leukocytopenia (51%), and they occurred more frequently in patients receiving ≥ 70 mg/m². However, the multi-variate analyses revealed that ≥ grade 3 ADRs did not correlate with the starting doses. Infection-related events (≥ grade 3) and interstitial pneumonia were observed in 15% and 1% of patients, respectively. Prostate-specific-antigen (PSA) flare appeared in 19% of 95 evaluable patients at median period of 26 days from treatment initiation. It continued with median duration of 39. 5 days. PSA response rate as defined ≥ 50% level decline was 37%(95%confidence interval: 27-47) in evaluable patients. It was low in patients receiving ≤ 60 mg/m² (18%). There was no notable difference between patients with initial dose of 75 and 70 mg/m². Further investigation for the longer term is warranted.

  7. Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

    Science.gov (United States)

    Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

    2017-10-01

    This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79–653) [DOSAGE ERROR CORRECTED] . The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

  8. A temporal interestingness measure for drug interaction signal detection in post-marketing surveillance.

    Science.gov (United States)

    Ji, Yanqing; Ying, Hao; Tran, John; Dews, Peter; Mansour, Ayman; Massanari, R Michael

    2014-01-01

    Drug-drug interactions (DDIs) can result in serious consequences, including death. Existing methods for identifying potential DDIs in post-marketing surveillance primarily rely on the FDA's (Food and Drug Administration) spontaneous reporting system. However, this system suffers from severe underreporting, which makes it difficult to timely collect enough valid cases for statistical analysis. In this paper, we study how to signal potential DDIs using patient electronic health data. Specifically, we focus on discovery of potential DDIs by analyzing the temporal relationships between the concurrent use of two drugs of interest and the occurrences of various symptoms using novel temporal association mining techniques we developed. A new interestingness measure called functional temporal interest was proposed to assess the degrees of temporal association between two drugs of interest and each symptom. The measure was employed to screen potential DDIs from 21,405 electronic patient cases retrieved from the Veterans Affairs Medical Center in Detroit, Michigan. The preliminary results indicate the usefulness of our method in finding potential DDIs for further analysis (e.g., epidemiology study) and investigation (e.g., case review) by drug safety professionals.

  9. Use of Carabids for the Post-Market Environmental Monitoring of Genetically Modified Crops

    Directory of Open Access Journals (Sweden)

    Oxana Skoková Habuštová

    2017-03-01

    Full Text Available Post-market environmental monitoring (PMEM of genetically modified (GM crops is required by EU legislation and has been a subject of debate for many years; however, no consensus on the methodology to be used has been reached. We explored the suitability of carabid beetles as surrogates for the detection of unintended effects of GM crops in general PMEM surveillance. Our study combines data on carabid communities from five maize field trials in Central Europe. Altogether, 86 species and 58,304 individuals were collected. Modeling based on the gradual elimination of the least abundant species, or of the fewest categories of functional traits, showed that a trait-based analysis of the most common species may be suitable for PMEM. Species represented by fewer than 230 individuals (all localities combined should be excluded and species with an abundance higher than 600 should be preserved for statistical analyses. Sixteen species, representing 15 categories of functional traits fulfill these criteria, are typical dominant inhabitants of agroecocoenoses in Central Europe, are easy to determine, and their functional classification is well known. The effect of sampling year is negligible when at least four samples are collected during maize development beginning from 1 April. The recommended methodology fulfills PMEM requirements, including applicability to large-scale use. However, suggested thresholds of carabid comparability should be verified before definitive conclusions are drawn.

  10. Prediction and Observation of Post-Admission Hematoma Expansion in Patients with Intracerebral Hemorrhage

    Science.gov (United States)

    Ovesen, Christian; Havsteen, Inger; Rosenbaum, Sverre; Christensen, Hanne

    2014-01-01

    Post-admission hematoma expansion in patients with intracerebral hemorrhage (ICH) comprises a simultaneous major clinical problem and a possible target for medical intervention. In any case, the ability to predict and observe hematoma expansion is of great clinical importance. We review radiological concepts in predicting and observing post-admission hematoma expansion. Hematoma expansion can be observed within the first 24 h after symptom onset, but predominantly occurs in the early hours. Thus capturing markers of on-going bleeding on imaging techniques could predict hematoma expansion. The spot sign observed on computed tomography angiography is believed to represent on-going bleeding and is to date the most well investigated and reliable radiological predictor of hematoma expansion as well as functional outcome and mortality. On non-contrast CT, the presence of foci of hypoattenuation within the hematoma along with the hematoma-size is reported to be predictive of hematoma expansion and outcome. Because patients tend to arrive earlier to the hospital, a larger fraction of acute ICH-patients must be expected to undergo hematoma expansion. This renders observation and radiological follow-up investigations increasingly relevant. Transcranial duplex sonography has in recent years proven to be able to estimate hematoma volume with good precision and could be a valuable tool in bedside serial observation of acute ICH-patients. Future studies will elucidate, if better prediction and observation of post-admission hematoma expansion can help select patients, who will benefit from hemostatic treatment. PMID:25324825

  11. Prediction and observation of post-admission hematoma expansion in patients with intracerebral hemorrhage

    DEFF Research Database (Denmark)

    Ovesen, Christian; Havsteen, Inger; Rosenbaum, Sverre

    2014-01-01

    within the hematoma along with the hematoma-size is reported to be predictive of hematoma expansion and outcome. Because patients tend to arrive earlier to the hospital, a larger fraction of acute ICH-patients must be expected to undergo hematoma expansion. This renders observation and radiological......Post-admission hematoma expansion in patients with intracerebral hemorrhage (ICH) comprises a simultaneous major clinical problem and a possible target for medical intervention. In any case, the ability to predict and observe hematoma expansion is of great clinical importance. We review...... radiological concepts in predicting and observing post-admission hematoma expansion. Hematoma expansion can be observed within the first 24 h after symptom onset, but predominantly occurs in the early hours. Thus capturing markers of on-going bleeding on imaging techniques could predict hematoma expansion...

  12. Peri-acetabular radiolucent lines: inter- and intra-observer agreement on post-operative radiographs

    OpenAIRE

    Kneif, D.; Downing, M.; Ashcroft, G. P.; Gibson, P.; Knight, D.; Ledingham, W.; Hutchison, J.

    2005-01-01

    Peri-acetabular radiolucent lines (RLLs) seen on “early” post-operative radiographs have been identified as a potential predictor of long-term implant performance. This study examines the inter- and intra-observer variation encountered when assessing such radiographs. Four consultant orthopaedic surgeons assessed the presence, extent and width of RLLs in 220 radiographs performed on 50 patients taken one to two weeks, six weeks, six months and one year following surgery. Inter-observer agreem...

  13. Drug- and herb-induced liver injury: Progress, current challenges and emerging signals of post-marketing risk.

    Science.gov (United States)

    Raschi, Emanuel; De Ponti, Fabrizio

    2015-07-08

    Drug-induced liver injury (DILI) and herb-induced liver injury is a hot topic for clinicians, academia, drug companies and regulators, as shown by the steadily increasing number of publications in the past 15 years. This review will first provide clues for clinicians to suspect idiosyncratic (unpredictable) DILI and succeed in diagnosis. Causality assessment remains challenging and requires careful medical history as well as awareness of multifaceted aspects, especially for herbs. Drug discontinuation and therapy reconciliation remain the mainstay in patent's management to minimize occurrence of acute liver failure. The second section will address novel agents associated with liver injury in 2014 (referred to as "signals"), especially in terms of clinical, research and drug development implications. Insights will be provided into recent trends by highlighting the contribution of different post-marketing data, especially registries and spontaneous reporting systems. This literature scrutiny suggests: (1) the importance of post-marketing databases as tools of clinical evidence to detect signals of DILI risk; and (2) the need for joining efforts in improving predictivity of pre-clinical assays, continuing post-marketing surveillance and design ad hoc post-authorization safety studies. In this context, ongoing European/United States research consortia and novel pharmaco-epidemiological tools (e.g., specialist prescription event monitoring) will support innovation in this field. Direct oral anticoagulants and herbal/dietary supplements appear as key research priorities.

  14. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

    Science.gov (United States)

    Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-01-01

    Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are

  15. Clinical safety and efficacy of "filgrastim biosimilar 2" in Japanese patients in a post-marketing surveillance study.

    Science.gov (United States)

    Tamura, Kazuo; Hashimoto, Kazue; Nishikawa, Kiyohiro

    2018-05-01

    We conducted a post-marketing surveillance to evaluate the safety and efficacy of TKN732, approved as "filgrastim biosimilar 2", in Japanese patients who developed neutropenia in the course of cancer chemotherapy or hematopoietic stem cell transplantation. A total of 653 patients were registered during the 2-year enrollment period starting from May 2013, and 627 and 614 patients were eligible for safety and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adverse drug reactions were reported in 33 patients (5.26%). Back pain was most frequently observed and reported in 20 patients (3.19%), followed by pyrexia (1.28%) and bone pain (0.96%). Risk factors for adverse reactions identified by logistic regression analyses were younger age, presence of past medical history, and lower total dose at the onset of adverse reactions. Among the 576 cancer patients who developed Grade 2-4 neutropenia after chemotherapy, recovery to Grade 1/0 was reported in 553 patients (96%) following filgrastim biosimilar 2 treatment. The median duration of neutrophil counts below 1500/μL was 5 days. In addition, all 11 patients who underwent hematopoietic stem cell transplantation had good responses to filgrastim biosimilar 2. In conclusion, this study showed that filgrastim biosimilar 2 has a similar safety profile and comparable effects to the original G-CSF product in the real world clinical setting. Copyright © 2018 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  16. [Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

    Science.gov (United States)

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

    The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

  17. Safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension: Japanese post-marketing surveillance data.

    Science.gov (United States)

    Yamazaki, Hiroyoshi; Kobayashi, Noriko; Taketsuna, Masanori; Tajima, Koyuki; Murakami, Masahiro

    2017-05-01

    To evaluate the long-term safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. This prospective, multicenter, noninterventional, post-marketing surveillance included patients with PAH who were observed for up to 2 years after initiation of tadalafil. Safety was assessed by analyzing the frequency of adverse drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious adverse drug reactions (SADRs). Effectiveness measurements included the assessment of the change in World Health Organization (WHO) functional classification of PAH, 6-minute walk test, cardiac catheterization, and echocardiography. Among 1676 patients analyzed for safety, the overall incidence of ADRs was 31.2%. The common ADRs (≥1.0%) were headache (7.0%), diarrhea (1.9%), platelet count decreased (1.8%), anemia, epistaxis, and nausea (1.6% each), flushing (1.3%), hepatic function abnormal (1.1%), hot flush, and myalgia (1.0% each). The common SADRs (≥0.3%) were cardiac failure (0.7%), interstitial lung disease, worsening of PAH, and platelet count decreased (0.3% each). Among 1556 patients analyzed for effectiveness, the percentages of patients with improvement of WHO functional class at 3 months, 1 year, and 2 years after the initiation of tadalafil, and last observation were 17.1%, 24.8%, 28.9%, and 22.5%, respectively. At all observation points (except pulmonary regurgitation pressure gradient at end diastole at 3 months), the mean 6-minute walk distance, cardiac catheterization, and echocardiogram measurements showed statistically significant improvement. This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in patients with PAH in Japan.

  18. Dabigatran Levels in Elderly Patients with Atrial Fibrillation: First Post-Marketing Experiences.

    Science.gov (United States)

    Bolek, Tomáš; Samoš, Matej; Škorňová, Ingrid; Stančiaková, Lucia; Staško, Ján; Galajda, Peter; Kubisz, Peter; Mokáň, Marián

    2018-05-08

    The number of elderly individuals with non-valvular atrial fibrillation (NV-AF) requiring long-term anticoagulation is rising. The pharmacokinetics of oral anticoagulants in elderly individuals may differ from that for younger patients. The aim of this study was to assess the dabigatran levels in elderly patients with NV-AF. A pilot prospective post-marketing study in patients with NV-AF on dabigatran therapy was performed; we enrolled 21 consecutive elderly patients (aged ≥ 75 years) on a reduced dabigatran regimen (110 mg twice daily) and compared them with 13 younger (≤ 70 years) individuals on reduced dabigatran therapy due to renal impairment and with 16 younger patients on standard dabigatran therapy (150 mg twice daily). Blood samples were taken for the assessment of dabigatran trough and peak levels. Dabigatran levels were measured with the Hemoclot ® Thrombin Inhibitor Assay. There were significant differences in dabigatran trough levels when comparing elderly patients on reduced dabigatran with non-elderly patients on reduced dabigatran (99.3 ± 73.6 vs 51.6 ± 25.6 ng/mL; p Similarly, the detected dabigatran peak levels were significantly higher in elderly patients on reduced dabigatran compared with non-elderly patients on reduced dabigatran (173.4 ± 116.2 vs 116.1 ± 19.1 ng/mL; p similar levels compared with younger individuals on standard dabigatran.

  19. The role of the pharmaceutical animal health industry in post-marketing surveillance of resistance.

    Science.gov (United States)

    Lens, S

    1993-06-01

    The pharmaceutical animal health industry must be committed to the total life cycle of products, i.e. during both the pre- and post-marketing period. Support of antibacterial agents during the postmarketing period is not restricted to maintaining a well-established distribution and promotion system. Care has to be taken continuously to maintain and/or improve the quality, safety (for user, target animal and environment) and clinical efficacy. The pharmaceutical industry contributes to this by: 1. Introducing antibacterials in different animal species for the most effective disease condition only and by ensuring the veterinary profession is informed about relevant findings on: a. the mechanism of action; b. pharmacodynamic properties; c. pharmacokinetic properties (plasma, target tissue); d. clinical efficacy data and in vitro sensitivity data; e. valid species-specific MIC breakpoints; f. precise dose and treatment regime. 2. Updating on a regular basis on: a. new findings on the mechanism of action (in vitro and in vivo); b. the optimal use program in the light of changes in animal husbandry, farm management and epidemiology on national and international level; c. adjustment of species-specific MIC breakpoints when necessary. 3. Providing continuous information in collaboration with animal health laboratories about: a. clinical field surveillance for efficacy (national, international); b. in vitro sensitivity/resistance surveillance (national, international); c. use of in vitro data to support prediction of in vivo efficacy. Surveillance of resistance, in vitro, is therefore part of a package of information needed on a routine basis by the pharmaceutical industry to allow the best possible use of antibacterials and to minimize induction of resistance.(ABSTRACT TRUNCATED AT 250 WORDS)

  20. Post-marketing surveillance of levofloxacin 0.5% ophthalmic solution for external ocular infections.

    Science.gov (United States)

    Kanda, Yoshiko; Kayama, Tomoko; Okamoto, Shinji; Hashimoto, Masako; Ishida, Chiemi; Yanai, Tomoko; Fukumoto, Mitsuru; Kunihiro, Eiichi

    2012-12-01

    Levofloxacin 0.5% ophthalmic solution is an antibacterial formulation, which was approved and marketed for the treatment of ocular infections in Japan in 2000. This study was designed to investigate the safety and efficacy of levofloxacin 0.5% ophthalmic solution in patients who received treatment for external ocular bacterial infections in regular clinical practice. Patients were recruited from more than 800 medical facilities in Japan, in accordance with Japanese Ministry of Health, Labour and Welfare ordinance guidelines. They were followed during three distinct time periods: April 2000 to December 2001, January 2002 to June 2003, and July 2003 to December 2004. Information from 6760 patients receiving levofloxacin for the treatment of a variety of ocular infections was collected. Levofloxacin was well tolerated: adverse drug reactions (ADRs) were reported in 42 of 6686 patients (0.63%), with no serious ADRs reported. The most commonly reported ADRs were ocular disorders such as blepharitis, eye irritation, and punctate keratitis. The incidence of ADRs did not differ significantly with age, but it was significantly higher in females (0.82%) than in males (0.36%; p = 0.028). A clinical response was observed in 95.5% of patients receiving levofloxacin, with no difference in response between the three time periods. The rate of response to levofloxacin by bacterial disease ranged from 97.4% in keratitis to 88.3% in dacryocystitis. The rate was lower in patients with dacryocystitis, elderly patients, patients with a long duration of illness, and relapsing cases (all p marketing surveillance of levofloxacin, conducted over 4 years, confirms the safety and efficacy of levofloxacin in regular clinical use and highlights that levofloxacin is a promising treatment for a variety of external ocular bacterial infections.

  1. [Application of nested case-control study on safe evaluation of post-marketing traditional Chinese medicine injection].

    Science.gov (United States)

    Xiao, Ying; Zhao, Yubin; Xie, Yanming

    2011-10-01

    The nested case-control study design (or the case-control in a cohort study) is described here as a new study design used in safe evaluation of post-marketing traditional Chinese medicine injection. In the nested case-control study, cases of a disease that occur in a defined cohort are identified and, for each, a specified number of matched controls is selected from among those in the cohort who have not developed the disease by the time of disease occurrence in the case. For many research questions, the nested case-control design potentially offers impressive reductions in costs and efforts of data collection and analysis compared with the full cohort approach, with relatively minor loss in statistical efficiency. The nested case-control design is particularly advantageous for studies in safe evaluation of post-marketing traditional Chinese medicine injection. Some examples of the application of nested case-control study were given.

  2. [Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

    Science.gov (United States)

    Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

    2018-01-01

     Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

  3. Limits and opportunities of marketeering tertiary education in post-colonial Zimbabwe

    OpenAIRE

    Patrick Sibanda

    2016-01-01

    This paper intended to assess the impact of marketeering tertiary education in Zimbabwe. The paper revealed that marketeering of tertiary education in Zimbabwe has drastically impacted on access to higher education and training. Poor and vulnerable students have found it difficult to access tertiary education due to escalating commercialized fees. Literature indicates that, even in developed countries like UK, marketeering tertiary education has led to decreased enrolments, diminishing prospe...

  4. Post-Marketing Regulation of Medicines Withdrawn from the Market Because of Drug-Attributed Deaths: An Analysis of Justification.

    Science.gov (United States)

    Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

    2017-05-01

    Several medicinal products have been withdrawn from the market because of drug-attributed deaths. However, there has been no investigation of whether such withdrawals were justified, and the extent to which confirmatory studies are used to investigate drug-adverse event relationships when deaths are reported is uncertain. We documented medicinal products withdrawn from the market because of drug-attributed deaths, identified confirmatory studies investigating the drug-adverse event relationships, examined whether withdrawals of medicinal products because of drug-attributed deaths after marketing were justified based on a mechanistic analysis, and examined the trends over time. We searched electronic and non-electronic sources to identify medicinal products that were withdrawn because of drug-attributed deaths. We used a previously published algorithm to examine whether the withdrawals of products were justified. We then searched PubMed and Google Scholar to identify studies investigating the drug-adverse event relationships, used the Oxford Centre for Evidence-Based Medicine criteria to document the levels of evidence, and assessed whether the evidence of an association was confirmed. We included 83 medicinal products. The reasons for withdrawal appeared to have been justified in 80 cases (96%). The median interval between the first reported adverse reaction that was related to the cause of death and the first reported death was 1 year (interquartile range = 1-3); products were withdrawn sooner when the interval between the first reported relevant adverse reaction and the first death was shorter. Confirmatory studies were conducted in 57 instances (69%), and there was evidence of an association in 52 cases (63%). Four products (5%) were re-introduced after initial withdrawal. Regulatory authorities have been justified in making withdrawal decisions when deaths have been attributed to medicinal products, using the precautionary principle when alternative decisions

  5. PERFORMANCE OF SELECTED PRE-HARVEST AND POST-HARVEST CORN AND SOYBEAN MARKETING STRATEGIES VS. ALTERNATIVE MARKET BENCHMARKS

    OpenAIRE

    Blue, E. Neal; Wisner, Robert N.; Baldwin, E. Dean

    2004-01-01

    This study was undertaken to update earlier work by the authors that analyzed selected preharvest pricing strategies utilizing options markets to establish a price floor for part of the crop in the spring, with additional pricing done by use of short hedges in early summer. The timing of implementing these strategies was moved back to late February if the previous year's U.S. crop was a weather-induced short crop. A weather-induced short crop as opposed to a government program induced short c...

  6. Observations and modeling of post-midnight uplifts near the magnetic equator

    Directory of Open Access Journals (Sweden)

    M. J. Nicolls

    2006-07-01

    Full Text Available We report here on post-midnight uplifts near the magnetic equator. We present observational evidence from digital ionosondes in Brazil, a digisonde in Peru, and other measurements at the Jicamarca Radio Observatory that show that these uplifts occur fairly regularly in the post-midnight period, raising the ionosphere by tens of kilometers in the most mild events and by over a hundred kilometers in the most severe events. We show that in general the uplifts are not the result of a zonal electric field reversal, and demonstrate instead that the uplifts occur as the ionospheric response to a decreasing westward electric field in conjunction with sufficient recombination and plasma flux. The decreasing westward electric field may be caused by a change in the wind system related to the midnight pressure bulge, which is associated with the midnight temperature maximum. In order to agree with observations from Jicamarca and Palmas, Brazil, it is shown that there must exist sufficient horizontal plasma flux associated with the pressure bulge. In addition, we show that the uplifts may be correlated with a secondary maximum in the spread-F occurrence rate in the post-midnight period. The uplifts are strongly seasonally dependent, presumably according to the seasonal dependence of the midnight pressure bulge, which leads to the necessary small westward field in the post-midnight period during certain seasons. We also discuss the enhancement of the uplifts associated with increased geomagnetic activity, which may be related to disturbance dynamo winds. Finally, we show that it is possible using simple numerical techniques to estimate the horizontal plasma flux and the vertical drift velocity from electron density measurements in the post-midnight period.

  7. Observations and modeling of post-midnight uplifts near the magnetic equator

    Directory of Open Access Journals (Sweden)

    M. J. Nicolls

    2006-07-01

    Full Text Available We report here on post-midnight uplifts near the magnetic equator. We present observational evidence from digital ionosondes in Brazil, a digisonde in Peru, and other measurements at the Jicamarca Radio Observatory that show that these uplifts occur fairly regularly in the post-midnight period, raising the ionosphere by tens of kilometers in the most mild events and by over a hundred kilometers in the most severe events. We show that in general the uplifts are not the result of a zonal electric field reversal, and demonstrate instead that the uplifts occur as the ionospheric response to a decreasing westward electric field in conjunction with sufficient recombination and plasma flux. The decreasing westward electric field may be caused by a change in the wind system related to the midnight pressure bulge, which is associated with the midnight temperature maximum. In order to agree with observations from Jicamarca and Palmas, Brazil, it is shown that there must exist sufficient horizontal plasma flux associated with the pressure bulge. In addition, we show that the uplifts may be correlated with a secondary maximum in the spread-F occurrence rate in the post-midnight period. The uplifts are strongly seasonally dependent, presumably according to the seasonal dependence of the midnight pressure bulge, which leads to the necessary small westward field in the post-midnight period during certain seasons. We also discuss the enhancement of the uplifts associated with increased geomagnetic activity, which may be related to disturbance dynamo winds. Finally, we show that it is possible using simple numerical techniques to estimate the horizontal plasma flux and the vertical drift velocity from electron density measurements in the post-midnight period.

  8. Rapid response tools and datasets for post-fire modeling: Linking Earth Observations and process-based hydrological models to support post-fire remediation

    Science.gov (United States)

    M. E. Miller; M. Billmire; W. J. Elliot; K. A. Endsley; P. R. Robichaud

    2015-01-01

    Preparation is key to utilizing Earth Observations and process-based models to support post-wildfire mitigation. Post-fire flooding and erosion can pose a serious threat to life, property and municipal water supplies. Increased runoff and sediment delivery due to the loss of surface cover and fire-induced changes in soil properties are of great concern. Remediation...

  9. Displacement in new economy labor markets: Post-displacement wage loss in high tech versus low tech cities.

    Science.gov (United States)

    Davis, Daniel J; Rubin, Beth A

    2016-11-01

    While scholars and politicians tout education as the salve to employment disruptions, we argue that the geography of the new economy, and the social closure mechanisms that geography creates, may be just as important as individuals' characteristics for predicting post-displacement wage loss (or gain). We use data from the 2012 Displaced Workers ement of the Current Population Survey and from the 2010 United States Census to test hypotheses linking local labor markets in different industrial contexts to post-displacement wage loss. Our results point to age as a closure mechanism, and to the partially protective effect of education in high-tech versus low-tech economic sectors. This study is the first to use national level data to examine how employment in high-tech cities influences post-displacement wages. These findings are relevant both for theorizing about the new economy and for public policy. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Pushed, pulled, or blocked? The elderly and the labor market in post-Soviet Russia.

    Science.gov (United States)

    Gerber, Theodore P; Radl, Jonas

    2014-05-01

    Russia provides an interesting context for studying the labor market experiences of the elderly because of its experience with market transition, its looming growth in the elderly dependency ratio, and its unusual pension policies that do not penalize pensioners for working. We use data from twenty surveys of the Russian population conducted from February 1991 to November 2007 to analyze the labor market participation and earnings of elderly Russians following market transition. Economic desperation, exacerbated by low pension levels, pushed some elderly to seek employment for income on the labor market. Elderly Russians with more education had more opportunities to work, and education differentials increased as market reforms progressed. The correlates of earnings operate similarly for retirement- and pre-retirement age Russians, with several exceptions: unobserved factors favoring employment are negatively associated with earnings for the elderly, occupation mediates most of the effects of education, and patterns of change over time differ somewhat. Elderly Russians are not disproportionately blocked from employment following market reforms. Following the initial transition shock, their labor market activity increased. Overall, both push and pull factors shape the employment and earnings of the elderly, affecting different segments of them. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. Valutazione della qualitá dei dati in uno studio post marketing

    Directory of Open Access Journals (Sweden)

    D. D’Alessandro

    2003-05-01

    Full Text Available

    Obiettivo: misurare l'affidabilita nella segnalazione
    di eventi avversi a vaccino nell'ambito di uno studio post-marketing sulla tollerabilita della vaccinazione antipneumococcica (AP in associazione con la vaccinazione antinfluenzale (AI nella popolazione anziana.


    Metodi: e stato predisposto un modello di regressione
    logistica per stimare gli OR tra la segnalazione di almeno un effetto collaterale locale (y ed alcune variabili individuali dei vaccinati (x1: eta .75 anni; x2: sesso; x3: allergie; x4: associazione AI+AP; x5: vivere solo; x6: patologie croniche. I medici aderenti al progetto (229 sono stati stratificati in cinque categorie in funzione dellfincidenza media di eventi avversi da loro registrata: 0% (29, 1-5%
    (68, 6-10% (50, 11-50% (72, .50% (10. Lo stesso modello di regressione e stato applicato ai quattro
    sotto-gruppi di vaccinati afferenti alle categorie di medici che hanno segnalato sintomi, per valutare la coerenza degli OR registrati nei gruppi.

    Risultati: tra i 29.086 vaccinati, l'f11,3% (3.278 ha segnalato almeno un evento avverso locale nelle
    72 ore successive alla vaccinazione: 9,9% tra i soggetti vaccinati con AI e 13,9% tra i vaccinati con
    AI+AP. I fattori significativamente associati all'faumento di rischio sono: AI+AP (OR 1,4; allergie (OR 1,3; patologie croniche (OR 1,3. L' applicazione del modello di regressione ai sotto-gruppi di vaccinati ha mostrato un trend negli OR per le categorie di medici che hanno segnalato dall'f1-5% fino all'f11- 50%, mostrando un'effettiva differenza di rischio dei pazienti.

    Tale coerenza non si e evinta nell'ultima categoria (.50%, dove tali fattori appaiono addiritura protettivi nei riguardi dei sintomi (AI+AP: OR 0,5; allergie: OR 0,7, o non associati
    (patologie croniche: OR 1,0.

    Conclusioni: il 4,3% dei medici arruolati nello studio (10 su 229 ha

  12. [Importance of Post-Marketing Studies in Gathering of Clinical Evidences for Proper Usage of Anti-Cancer Drugs, and the StudyRequirements for Their Credibility].

    Science.gov (United States)

    Inagaki, Osamu

    2016-04-01

    Pharmaceutical companies recognize the importance of post-marketing studies because they are crucial in the generation of clinical evidences for the usage of new medicines. To generate clinical evidences, quality of post-marketing studies should be well controlled from view point of "ethical conduction" and "reliability of results". In addition, control of conflict of interest (COI) between researchers and industries is also indispensable and is requested for the transparency of the studies. Japan Pharmaceutical Manufacturers Association(JPMA)stresses its commitment to the progressof transparency in post-marketing studies.

  13. Tendances Carbone no. 92. Carbon markets and the post-2020 Agreement

    International Nuclear Information System (INIS)

    Marcu, Andrei

    2014-06-01

    Among the publications of CDC Climat Research, 'Tendances Carbone' bulletin specifically studies the developments of the European market for CO 2 allowances. Beside some statistical figures about energy production/consumption and carbon markets, this issue specifically addresses the following points: - EU ETS reforms: on 25 June, the EU Commission will host a panel of experts to discuss technical aspects of the proposal of the Market Stability Reserve. - Market Stability Reserve of the EU ETS: Germany supports the Commission proposal of a market stability reserve and calls for a launch of the mechanism significantly before 2020, i.e. already in 2017. - 2030 energy and climate package: on 26 and 27 June, the EU Council will discuss the target of CO 2 emissions reduction of 40% by 2030 to take a final decision as soon as possible and later in October 2014

  14. Federal Market Information Technology in the Post Flash Crash Era: Roles for Supercomputing

    Energy Technology Data Exchange (ETDEWEB)

    Bethel, E. Wes; Leinweber, David; Ruebel, Oliver; Wu, Kesheng

    2011-09-16

    This paper describes collaborative work between active traders, regulators, economists, and supercomputing researchers to replicate and extend investigations of the Flash Crash and other market anomalies in a National Laboratory HPC environment. Our work suggests that supercomputing tools and methods will be valuable to market regulators in achieving the goal of market safety, stability, and security. Research results using high frequency data and analytics are described, and directions for future development are discussed. Currently the key mechanism for preventing catastrophic market action are “circuit breakers.” We believe a more graduated approach, similar to the “yellow light” approach in motorsports to slow down traffic, might be a better way to achieve the same goal. To enable this objective, we study a number of indicators that could foresee hazards in market conditions and explore options to confirm such predictions. Our tests confirm that Volume Synchronized Probability of Informed Trading (VPIN) and a version of volume Herfindahl-Hirschman Index (HHI) for measuring market fragmentation can indeed give strong signals ahead of the Flash Crash event on May 6 2010. This is a preliminary step toward a full-fledged early-warning system for unusual market conditions.

  15. The clinical efficacy of a clarithromycin-based regimen for Mycobacterium avium complex disease: A nationwide post-marketing study.

    Science.gov (United States)

    Kadota, Jun-Ichi; Kurashima, Atsuyuki; Suzuki, Katsuhiro

    2017-05-01

    The revised 2007 American Thoracic Society/Infectious Diseases Society of America statement recommend clarithromycin-based combination therapy for treatment of Mycobacterium avium complex lung disease and stipulates approximately 1 year of continuous treatment after bacilli negative conversion. However, supporting data are insufficient. Our objective was to obtain data on the clinical outcome of clarithromycin-based daily regimens by conducting a nationwide retrospective post-marketing study of M. avium complex lung disease. In accordance with the Japanese guidelines, patients were enrolled in this survey according to their chest radiographic findings and microbiologic test results. They were treated with a multidrug regimen including clarithromycin, rifampicin, and ethambutol (clarithromycin-based regimen) until bacilli negative conversion, and the treatment was continued for approximately 1 year after the initial conversion. Data were collected before administration, at the time of bacilli negative conversion, at the end of treatment, and at 6 months after the end of treatment. Of the 466 subjects enrolled in the study, 271 patients who received clarithromycin at 800 mg/day underwent evaluation for M. avium complex disease. The final bacilli negative conversion rate in those patients was 94.7%. The bacteriological relapse rate was 5.0% (5/100 patients). Bacteriological relapse was noted in patients treated for less than 15 months after conversion. No life-threatening or serious adverse drug reactions were observed. This study demonstrated that a clarithromycin-based daily regimen can yield a high bacteriological conversion rate in M. avium complex disease. After conversion, treatment for less than 15 months might be insufficient to prevent bacteriological relapse. Copyright © 2017 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  16. Marketing.

    Science.gov (United States)

    Chambers, David W

    2010-01-01

    There is not enough marketing of dentistry; but there certainly is too much selling of poor quality service that is being passed off as dentistry. The marketing concept makes the patient and the patients' needs the ultimate criteria of marketing efforts. Myths and good practices for effective marketing that will promote oral health are described under the traditional four "Ps" categories of "product" (best dental care), "place" (availability), "promotion" (advertising and other forms of making patients aware of available services and how to use them), and "price" (the total cost to patients of receiving care).

  17. The relationship between in-store marketing and observed sales of sustainable products : A shopper marketing view

    NARCIS (Netherlands)

    van Nierop, E.; van Herpen, E.; Sloot, L.M.

    2011-01-01

    To stimulate sales of sustainable products, retailers need to know whether their in-store instruments effectively influence their market shares. This study uses actual sales data and a multilevel modeling approach to describe the market shares of sustainable brands according to price level, price

  18. Evidence-based review of seeding in post-fire rehabilitation and native plant market feasibility

    Science.gov (United States)

    Donna L. Peppin

    2009-01-01

    A changing climate and fire regime shifts in the western United States have led to an increase in revegetation activities, in particular post-wildfire rehabilitation and the need for locally-adapted plant materials. Broadcast seeding is one of the most widely used post-wildfire emergency response treatments to minimize soil erosion, promote plant community recovery,...

  19. Forms and Factors of Animal Products Marketing in the early post-Meiji Years

    OpenAIRE

    Ono, Seishi

    1982-01-01

    As far as the period after the Meiji era is concerned, at its begining marketing of animal products was formed in conlpliance with the properties of products as a public commodity and the amount of investment needed. The former factor depends basically on the divisibility and the preservation possibilities of the products. The latter is the capital needed for marketing and production. 1) Eggs are the most divisible and preservable of all the animal products. Also, hens can be kept with sm...

  20. A Sociocultural-Theory-Based Study of the Impact of Mediation during Post- Observation Conferences on Language Teacher Learning

    Science.gov (United States)

    Harvey, Jane

    2011-01-01

    The post-observation conference offers a potentially fecund context for promoting language teacher learning, but very little research has been conducted into how this actually happens. Taking Vygotskian sociocultural theory as its theoretical framework, this study examined the mediational discourse of a series of post-observation conferences…

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

    Directory of Open Access Journals (Sweden)

    Masakazu Fujiwara

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

  2. A Post-marketing Surveillance Study of Chronic Wounds Treated With a Native Collagen Calcium Alginate Dressing.

    Science.gov (United States)

    Sabo, Matthew; Le, Lam; Yaakov, Raphael A; Carter, Marissa; Serena, Thomas E

    2018-04-01

    Chronic wounds (ie, wounds that fail to progress through a normal, orderly, timely sequence of repair) continue to pose significant clinical and economic burdens. A prospective, descriptive, 3-week post-marketing surveillance study was conducted across 3 wound care centers in the United States to evaluate the effectiveness of a collagen calcium alginate dressing on chronic wounds in conjunction with standard care (SC) practices (eg, offloading, debridement, compression) to support healing. Eligible participants had to be >18 years of age, have at least 1 chronic wound, and no known sensitivity to collagen. Demographic characteristics were recorded at the screening visit on case report forms. At each visit, wound-related pain was assessed using the Visual Analog Scale along with wound characteristics including size (using digital planimetry), wound exudate (minimal, moderate, heavy), and odor (none, mild). Participants were monitored for adverse events as well as infection based on signs and symptoms in and around the local wound bed, the deeper structures, and the surrounding skin. An intention-to-treat approach was used for all analyses. If an observation was missing, the last observation carried forward principle was used. For wounds that healed, pain and exudate were set to 0 (no pain/exudate) at visit 4. Descriptive, paired t tests and the Wilcoxon signed rank test were used to analyze the data. Of the 31 participants (15 men, 16 women, mean age 66.6 years), most (13, 42%) had a diabetic foot ulcer or venous leg ulcer (10, 32%); median duration of all wounds was 148 days. Thirty (30) patients completed the study. The mean number of comorbidities was 10.6 ± 6.3, and patients used a mean of 9.3 ± 5.64 prescription or over-the-counter medications. For all wounds combined, mean wound area was 4.8 ± 8.38 cm2 at baseline. At week 3, a decrease in wound area of 38.1% was noted (median: 45% ± 42.54; P = .006); 3 wounds healed completely. The change in wound exudate

  3. [Clinical observation of post-extension pulling massage in treating lumbar disc herniation].

    Science.gov (United States)

    Lü, Li-Jiang; Ke, Xue-Ai; Mao, Xu-Dan; Chen, Xiao-Jie; Wu, Fang-Chao; Tong, Hong-Jie

    2010-10-01

    To observe the clinical effect of post-extension pulling massage in treating lumbar disc herniation. From January 2008 to December 2008, 61 patients with lumbar disc herniation, 34 males and 27 females, ranging in age from 17 to 67 years with an average of 42.6 years, were treated with post-extension pulling massage after continued traction for 30 minutes (on alternate days one time, 3 times as a course of treatment). There was bulging type in 9 cases, hernia type in 22, free type in 30. After a course of treatment, the clinical effects were evaluated according to standard of Macnab, the items included pain, lumbar activity, normal work and life of patients. All patients were followed up from 1 to 9 months with an average of 4.6 months. After treatment, the symptoms and signs of patients had obviously improved in above aspects. According to standard of Macnab, 48 cases got excellent result, 10 good, 2 fair, 1 poor. The post-extension pulling massage in treating lumbar disc herniation can obtain satisfactory results, which have localized site of action, small compression for vertebral body and can reduce accidental injury.

  4. A theory of planning horizons (1: market design in a post-neoclassical world

    Directory of Open Access Journals (Sweden)

    Frederic B. Jennings, Jr.

    2012-05-01

    Full Text Available The neoclassical case supporting competitive frames and market solutions has failed to promote stable world-wide economic development. Other approaches in economics incorporate social culture, increasing returns, market power, ecological limits and complementarity, yielding broader applications for development theory. In this paper a theory of planning horizons is introduced to raise some meaningful questions about the traditional view with respect to its substitution, decreasing returns and independence assumptions. Suppositions of complementarity, increasing returns and interdependence suggest that competition is inefficient by upholding a myopic culture resistant to learning. Growth – though long believed to rise from markets and competitive values – may not derive from these sources. Instead, as civilizations advance, shifting from material wants to higher-order intangible output, they evolve from market tradeoffs (substitution and scarcity into realms of common need (complementarity and abundance. The policy implications of horizonal theory are explored, with respect to regulatory aims and economic concerns. Such an approach emphasizes strict constraints against entry barriers, ecological harm, market power abuse and ethical lapses. Social cohesion – not competition – is sought as a means to extend horizons and thereby increase efficiency, equity and ecological health. The overriding importance of horizon effects for regulatory assessment dominates other orthodox standards in economics and law. Reframing economics along horizonal lines suggests some meaningful insight on the proper design of economic systems.

  5. Construction and analysis of a human hepatotoxicity database suitable for QSAR modeling using post-market safety data

    International Nuclear Information System (INIS)

    Zhu, Xiao; Kruhlak, Naomi L.

    2014-01-01

    Graphical abstract: - Abstract: Drug-induced liver injury (DILI) is one of the most common drug-induced adverse events (AEs) leading to life-threatening conditions such as acute liver failure. It has also been recognized as the single most common cause of safety-related post-market withdrawals or warnings. Efforts to develop new predictive methods to assess the likelihood of a drug being a hepatotoxicant have been challenging due to the complexity and idiosyncrasy of clinical manifestations of DILI. The FDA adverse event reporting system (AERS) contains post-market data that depict the morbidity of AEs. Here, we developed a scalable approach to construct a hepatotoxicity database using post-market data for the purpose of quantitative structure–activity relationship (QSAR) modeling. A set of 2029 unique and modelable drug entities with 13,555 drug-AE combinations was extracted from the AERS database using 37 hepatotoxicity-related query preferred terms (PTs). In order to determine the optimal classification scheme to partition positive from negative drugs, a manually-curated DILI calibration set composed of 105 negatives and 177 positives was developed based on the published literature. The final classification scheme combines hepatotoxicity-related PT data with supporting information that optimize the predictive performance across the calibration set. Data for other toxicological endpoints related to liver injury such as liver enzyme abnormalities, cholestasis, and bile duct disorders, were also extracted and classified. Collectively, these datasets can be used to generate a battery of QSAR models that assess a drug's potential to cause DILI

  6. Linking Entrepreneurial Orientation to Firm Performance in a Post-Socialist Market Context: the Case of Hungary

    Directory of Open Access Journals (Sweden)

    David KOVACS

    2016-12-01

    Full Text Available Entrepreneurial orientation provoked the interest of numerous scholars as well as political and administrative decision-makers. Both start-ups and already established corporate entities are increasingly persecuting new opportunities, products, and business models in order to establish superiority above their competitive environment. The tendencies evince an optimist impact of entrepreneurial orientation on business performance, namely on financial performance. Beyond the aforementioned relationship, there are impulses such as environmental and organizational factors, which are affecting the businesses. The results of this study provide evidence of the effect of entrepreneurial orientation on business performance in a post-socialist context. We test the impact of three moderators on this bivariate relationship. In contrast to the substantial body of literature for Western markets, we contribute to minimizing the considerable gap of research in post-socialist economies. Entrepreneurial orientation as an organizational behavior may affect the financial performance of businesses differently in distinct market contexts. Both, internal and external factors are crucial to identifying, analyze and monitor, to achieve superior performance and to overcome competitors. This study builds upon a stratified sampling survey of Hungarian company owners and managers from the Amadeus database. The study uses a deductive approach. For the analysis, we rely on structural equation modeling using the PLS algorithm. Our study contributes to the existing literature by means of confirming the entrepreneurial orientation to firm performance relationship for Hungary. In this context, we test the moderating effects of environmental dynamism, environmental hostility as environmental factors and firm age as an organizational factor. Environmental hostility is closely related to an unfavorable environment, deriving from rapid and radical changes in the industry, which are

  7. Post-market drug evaluation research training capacity in Canada: an environmental scan of Canadian educational institutions.

    Science.gov (United States)

    Wiens, Matthew O; Soon, Judith A; MacLeod, Stuart M; Sharma, Sunaina; Patel, Anik

    2014-01-01

    Ongoing efforts by Health Canada intended to modernize the legislation and regulation of pharmaceuticals will help improve the safety and effectiveness of drug products. It will be imperative to ensure that comprehensive and specialized training sites are available to train researchers to support the regulation of therapeutic products. The objective of this educational institution inventory was to conduct an environmental scan of educational institutions in Canada able to train students in areas of post-market drug evaluation research. A systematic web-based environmental scan of Canadian institutions was conducted. The website of each university was examined for potential academic programs. Six core programmatic areas were determined a priori as necessary to train competent post-market drug evaluation researchers. These included biostatistics, epidemiology, pharmacoepidemiology, health economics or pharmacoeconomics, pharmacogenetics or pharmacogenomics and patient safety/pharmacovigilance. Twenty-three academic institutions were identified that had the potential to train students in post-market drug evaluation research. Overall, 23 institutions taught courses in epidemiology, 22 in biostatistics, 17 in health economics/pharmacoeconomics, 5 in pharmacoepidemiology, 5 in pharmacogenetics/pharmacogenomics, and 3 in patient safety/pharmacovigilance. Of the 23 institutions, only the University of Ottawa offered six core courses. Two institutions offered five, seven offered four and the remaining 14 offered three or fewer. It is clear that some institutions may offer programs not entirely reflected in the nomenclature used for this review. As Heath Canada moves towards a more progressive licensing framework, augmented training to increase research capacity and expertise in drug safety and effectiveness is timely and necessary.

  8. E-cigarette marketing in UK stores : an observational audit and retailers' views

    OpenAIRE

    Eadie, D; Stead, M; MacKintosh, A M; MacDonald, L; Purves, R; Pearce, J; Tisch, C; van der Sluijs, Winfried; Amos, A; MacGregor, A; Haw, S

    2015-01-01

    This study was supported by grant 10/3000/07 from the National Institute for Health Research. OBJECTIVES: To explore how e-cigarettes are being promoted at point of sale in the UK and how retailers perceive market trends. SETTING: Fixed retail outlets subject to a ban on the display of tobacco products. PARTICIPANTS: Observational audit of all stores selling tobacco products (n=96) in 4 Scottish communities, conducted over 2 waves 12 months apart (2013-2014), and qualitative interviews wit...

  9. Integration of Financial Markets in Post Global Financial Crises and Implications for British Financial Sector: Analysis Based on A Panel VAR Model

    OpenAIRE

    Nasir, M; Du, M

    2017-01-01

    This study analyses the dynamics of integration among global financial markets in the context of Global Financial Crisis (2008) by employing a Panel Vector Autoregressive (VAR) model on the monthly data of nine countries and three markets from Jan 2003 to Oct 2015. It was found that there has been a shift in the association among the global financial markets since Global Financial Crisis (GFC).Moreover, the British financial sectors in Post-GFC world clearly showed a change in the association...

  10. A data-capture system for post-marketing surveillance of drugs that integrates with hospital electronic health records

    Directory of Open Access Journals (Sweden)

    Yamamoto K

    2011-04-01

    Full Text Available Keiichi Yamamoto1, Shigemi Matsumoto2, Kazuhiro Yanagihara2, Satoshi Teramukai1, Masanori Fukushima1,2,31Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan; 2Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan; 3Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, JapanPurpose: In conventional clinical studies, the cost of data management for the purposes of quality control tend to be high and collecting paper-based case report forms (CRFs can be burdensome, because paper-based CRFs must be developed and filled out for each clinical study protocol. Use of electronic health records (EHRs for this purpose could reduce costs and improve data quality in clinical studies. Kyoto University Hospital launched an EHR system in January 2005. At the same time, a replicate of that database was established for other purposes. At the Outpatient Oncology Unit of Kyoto University Hospital we developed a data-capture system that includes a cancer clinical database system and a data warehouse for outcomes studies. This system allows us to accumulate data at low cost and apply it to various uses in clinical or outcomes studies. Here we report on the application of this system to the post-marketing surveillance of drugs.Methods: We evaluated the availability of this system and identified problems for future development. With this system investigators can register cases for post-marketing surveillance, and the registered cases are listed on a screen. When CRFs for a particular case are required, data can be extracted from the list and CRFs are produced in PDF format.Results and conclusion: In this study we confirmed the applicability of our new system to post-marketing surveillance in providing prompt and efficient data exchange. We expect it to reduce the cost of data management and analysis and to improve the quality of data in post-marketing

  11. [Taking evaluation of post-marketing as point of cut-in to promote systematic research of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Yong-yan; Wang, Zhi-fei; Xie, Yan-ming

    2014-09-01

    Research on post-marketing Chinese medicine should be the systematic study from application to mechanism. Clinical evaluation is the basis of mechanism study, we can find the clue from clinical evaluation, then make a mechanism study to find the reason, then apply the results to clinic. So it is a virtuous circle. In order to achieve it, we cannot be limited to traditional Chinese medicine, we should form multi-disciplinary team under the direction of grand science thinking, try hard to put industry-university-research institute collaboration association to use, and if necessary, explore the new model of the whole nation system. An appropriate operation mechanism is very important.

  12. The Spanish Gas Market: Demand Trends Post Recession and Consequences for the Industry

    OpenAIRE

    2011-01-01

    In parallel with a flourishing economy, the natural gas industry in Spain was characterised by rapid consumption growth in the late 1990s and 2000s. Infrastructure and supplies were designed to meet the needs of a gas market growing at double digit rates each year. This high growth rate – for a European gas market – was expected to continue until at least the mid-2010s. By 2011, this outlook was replaced by a more pessimistic one. Firstly, the country’s economy was hit hard by the global rece...

  13. Effects of Intensifying Labor Market Programs on Post-Unemployment Wages: Evidence From a Controlled Experiment

    DEFF Research Database (Denmark)

    Sørensen, Kenneth Lykke

    This paper investigates effects on wages of a Danish field experiment intensifying Active Labor Market Policies (ALMP).We link unemployed workers who participated in an ALMP experiment called “Quickly Back” carried out by the Danish Ministry of Employment 2005-2006 in two counties to matched...... employer-employee and public transfer register data up to 2008 enabling us to analyze exact labor market transitions and jobs of the participants. Men in one of the counties experienced significant higher probability of earning higher short and long term wages after treatment. Treated men in the other...

  14. The POST trial: initial post-market experience of the Penumbra system: revascularization of large vessel occlusion in acute ischemic stroke in the United States and Europe.

    Science.gov (United States)

    Tarr, Robert; Hsu, Dan; Kulcsar, Zsolt; Bonvin, Christophe; Rufenacht, Daniel; Alfke, Karsten; Stingele, Robert; Jansen, Olav; Frei, Donald; Bellon, Richard; Madison, Michael; Struffert, Tobias; Dorfler, Arnd; Grunwald, Iris Q; Reith, Wolfgang; Haass, Anton

    2010-12-01

    The purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application. A retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events. Results were compared with those of the Penumbra pivotal trial. A total of 157 vessels were treated. Mean baseline values at enrollment were: age 65 years, NIHSS score 16. After use of the Penumbra system, 87% of the treated vessels were revascularized to TIMI 2 (54%) or 3 (33%) as compared with 82% reported in the Pivotal trial. Nine procedural serious adverse events were reported in 157 patients (5.7%). All-cause mortality was 20% (32/157), and 41% had a mRS of ≤2 at 90-day follow-up as compared with only 25% in the Pivotal trial. Patients who were successfully revascularized by the Penumbra system had significantly better outcomes than those who were not. Initial post-market experience of the Penumbra system revealed that the revascularization rate and safety profile of the device are comparable to those reported in the Pivotal trial. However, the proportion of patients who had good functional outcome was higher than expected.

  15. Post-marketing surveillance of chemicals: organisations and databases : Workshop report

    NARCIS (Netherlands)

    Bouwmeester M; van Drongelen A; Graven C; Hernandez L; Herremans J; de Kaste D; Razenberg L; Vandebriel R; Piersma A; VTS; GZB

    2018-01-01

    The safety evaluation of chemicals is in general performed by the government, importer or manufacturer before marketing, and is based on (inter)national legislation. Less is known about the exact products in which chemicals are processed. Even though multiple institutions in the Netherlands are

  16. Post-School-Age Training among Women: Training Methods and Labor Market Outcomes at Older Ages.

    Science.gov (United States)

    Hill, Elizabeth T.

    2001-01-01

    Uses the NLS Mature Women's Cohort to examine Labor Market effects of education and training at preretirement age. Younger, more educated women tend to train more than older women. On-the-job training is more strongly associated with wage growth than is formal education. (Contains 18 references.) (MLH)

  17. Dynamic Gender Differences in a Post-Socialist Labor Market: Russia, 1991-1997

    Science.gov (United States)

    Gerber, Theodore P.; Mayorova, Olga

    2006-01-01

    We examine how the shift from state socialism affects gender inequality in the labor market using multivariate models of employment exit, employment entry, job mobility and new job quality for 3,580 Russian adults from 1991 through 1997. Gender differences changed in a complex fashion. Relative to men, women gained greater access to employment,…

  18. Young people and the post-recession labour market in the context of Europe 2020

    NARCIS (Netherlands)

    Chung, H.; Bekker, S.; Houwing, H.

    2012-01-01

    This article examines how the recent global recession, together with the general flexibilization of labour markets, is affecting young people. We examine different forms of social exclusion, including unemployment, temporary employment contracts and periods of inactivity, as well as the subjective

  19. Safety and effectiveness of gemcitabine in 260 patients with biliary tract cancer in a Japanese clinical practice based on post-marketing surveillance in Japan.

    Science.gov (United States)

    Okubo, Sumiko; Nishiuma, Shinichi; Kobayashi, Noriko; Taketsuna, Masanori; Taniai, Hisashi

    2012-11-01

    Gemcitabine was approved for the treatment of biliary tract cancer in 2006 in Japan. While biliary tract cancer is usually associated with patients 70 years of age or older and/or those who tend to have underlying liver dysfunction, data on this population were limited in the Japanese Phase II study of gemcitabine. Thus, further evaluation of safety and effectiveness in this population was planned. This special post-marketing surveillance was conducted as an observational study on the use of gemcitabine in a clinical practice setting. Gemcitabine-naïve patients with biliary tract cancer were enrolled from 2006 to 2008 and observed over 12 months; one or more doses of gemcitabine were administered during the period. Data such as patient background, treatment details, adverse events occurring during the observational period, laboratory values of liver enzyme and survival status were collected 3 and 12 months after the start of therapy. Of the 285 patients registered for the study, 260 were included in the analysis. The mean age was 66.9 years. There were 120 patients (46.2%) classified as elderly (70 years or older). Haematotoxicities were the most common adverse drug reactions. In the elderly and the non-elderly, adverse drug reactions (serious) occurred in 48.3% (20.8%) and 50.7% (12.9%), respectively. The overall estimated 1-year survival rate was 52.5% (95% confidence interval, 45.9-58.7%). In line with previous clinical and post-marketing studies conducted in Japan, the results of this study suggest that gemcitabine could be used safely and effectively for biliary tract cancer patients including the elderly.

  20. An Ethical Justification for Expanding the Notion of Effectiveness in Vaccine Post-Market Monitoring: Insights from the HPV Vaccine in Canada.

    Science.gov (United States)

    Komparic, Ana; Smith, Maxwell J; Thompson, Alison

    2016-04-01

    Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public's health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market monitoring ought to be expanded in two ways to reflect a 'public health notion of post-market effectiveness', which incorporates normative public health considerations: (i) effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and (ii) the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize (and minimize) a vaccine's effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense.

  1. Returns to the market: valuing human capital in the post-transition Czech and Slovak Republics

    Czech Academy of Sciences Publication Activity Database

    Filer, R.; Jurajda, Štěpán; Plánovský, J.

    -, č. 125 (1999), s. 1-26 ISSN 1211-3298 Institutional research plan: CEZ:AV0Z7085904 Keywords : human capital * post-transition Czech and Slovak Republics Subject RIV: AH - Economics http://www.cerge-ei.cz/pdf/wp/Wp125.pdf

  2. Collateral damage: Educational attainment and labor market outcomes among German war and post-war cohorts

    OpenAIRE

    Hendrik Jürges

    2012-01-01

    We use data from the West German 1970 census to explore the link between being born during or shortly after World War II and educational and labor market outcomes 25 years later. We document, for the first time, that men and women born in the relatively short period between November 1945 and May 1946 have significantly and substantially lower educational attainment and occupational status than cohorts born shortly before or after. Several alternative explanations for this new finding are put ...

  3. [Clinical observation of post-herpetic neuralgia treated with TCM herbal cupping therapy].

    Science.gov (United States)

    Wu, Xi; Hu, Hui; Guo, Liang; Wang, Hui

    2013-02-01

    To compare the difference in the efficacy on post-herpetic neuralgia among TCM herbal cupping therapy, Chinese medicine thermal compressing therapy and mecobalamine. Fifty-seven cases were randomized into a TCM herbal cupping group, a thermal compressing group and a western medicine group, 19 cases in each one. The oral administration of ibuprofen was applied in every group. In the herbal cupping group, the bamboo cups soaked in the boiled Chinese herbal decoction were sucked on the most significant painful area. In the thermal compressing group, the towel soaked in the boiled Chinese herbal decoction was compressed on the most significant painful area. In the medication group, the muscular injection of mecobalamine was adopted. The treatment was given once a day, for 2 weeks totally in each group. SF-MPQ score and clinical efficacy before and after treatment were observed in each group. The remarkable effective rates were 78.9% (15/19), 36.8% (7/19) and 5.3% (1/19) in the TCM herbal cupping group, thermal compressing group and western medicine group separately. The efficacy in the TCM herbal cupping group was significantly superior to the thermal compressing group and western medicine group (all P cupping group was reduced more significantly as compared with the thermal compressing group and western medicine group (all P cupping therapy achieves the superior efficacy for post-herpetic neuralgia and relieves pain effectively of the patients, which is more advantageous than CM herbal thermal compressing therapy and Mecobalamine.

  4. One size (never) fits all: segment differences observed following a school-based alcohol social marketing program.

    Science.gov (United States)

    Dietrich, Timo; Rundle-Thiele, Sharyn; Leo, Cheryl; Connor, Jason

    2015-04-01

    According to commercial marketing theory, a market orientation leads to improved performance. Drawing on the social marketing principles of segmentation and audience research, the current study seeks to identify segments to examine responses to a school-based alcohol social marketing program. A sample of 371 year 10 students (aged: 14-16 years; 51.4% boys) participated in a prospective (pre-post) multisite alcohol social marketing program. Game On: Know Alcohol (GO:KA) program included 6, student-centered, and interactive lessons to teach adolescents about alcohol and strategies to abstain or moderate drinking. A repeated measures design was used. Baseline demographics, drinking attitudes, drinking intentions, and alcohol knowledge were cluster analyzed to identify segments. Change on key program outcome measures and satisfaction with program components were assessed by segment. Three segments were identified; (1) Skeptics, (2) Risky Males, (3) Good Females. Segments 2 and 3 showed greatest change in drinking attitudes and intentions. Good Females reported highest satisfaction with all program components and Skeptics lowest program satisfaction with all program components. Three segments, each differing on psychographic and demographic variables, exhibited different change patterns following participation in GO:KA. Post hoc analysis identified that satisfaction with program components differed by segment offering opportunities for further research. © 2015, American School Health Association.

  5. Evaluation of the Relative Abuse of an OROS® Extended-release Hydromorphone HCI Product: Results from three Post-market Surveillance Studies.

    Science.gov (United States)

    Butler, Stephen F; McNaughton, Emily C; Black, Ryan A; Cassidy, Theresa A

    2018-01-02

    Formulating prescription opioids to limit abuse remains a priority. OROS® extended-release (ER) hydromorphone HCl (EXALGO®) may have low abuse potential. Three post-marketing studies of the relative abuse liability of OROS hydromorphone ER were conducted. Estimates of abuse, unadjusted and adjusted for prescription volume, were generated for OROS hydromorphone ER and comparators from Q2 2010 through Q2 2014 for a high-risk, substance abuse treatment population and the general population using poison control center data. Comparators were selected for compound, market penetration, and route of administration (ROA) profile. ROA comparisons were made among the substance abuse treatment population. Internet discussion was examined to determine abusers' interest in and desire for the OROS formulation. Examination of abuse prevalence among adults within substance abuse treatment, intentional poison exposures and Internet discussion levels generally support the hypothesis that OROS hydromorphone ER may have lower abuse potential than many other opioid products. OROS hydromorphone ER also appears to be abused less often by alternate ROAs (e.g., snorting and injection). Lower levels of online discussion were observed along with relatively low endorsement for abuse. Abuse of OROS hydromorphone ER was observed in high-risk substance abuse and general population samples but at a very low relative prevalence. Evidence suggests it may be less often abused by alternate ROAs than some comparators. Online data did not find evidence of high levels of desire for OROS hydromorphone ER by recreational abusers. Continued monitoring of this product's abuse liability is warranted.

  6. TRENDS IN THE UKRAINIAN LOAN MARKET IN THE POST-CRISIS PERIOD

    Directory of Open Access Journals (Sweden)

    Tetiana Kubakh

    2015-11-01

    Full Text Available The purpose of the paper is to systematize the data of the credit market of Ukraine in the period of economic and political turmoil and the beginning of military confrontation with Russia. The method of extended studies allows to trace the changes that have occurred not only in the banking system, but also in the whole of the economy. Methodology. The study is based on a comparison of data on a number of indicators that were taken as a basis and allow to fully analyze the credit market as a component of the capital market in the period from 2000 to 2013. Results of the survey allowed to clearly identify the problems that impede the stable development of the banking system of Ukraine, among which are the following: high cost of banking products, the marriage of skilled personnel and lack of confidence in banks, low level of culture of users of financial products, low income, high yield deposit operations increases the cost of credit products, slowing of economic development, lack of reforms, social and political tensions, armed conflict with a neighboring state. Practical implications. A clear definition of the problems in the credit market as a component of the banking system helped identify a number of areas that allow us to solve the situation. Among them, first of all, we should highlight the following: the bank regulator (the National Bank of Ukraine, must take a great responsibility as the authority of last resort in the refinancing of a bank, on a continuous basis to implement the stress testing of banks in Ukraine, to stabilize inflation and return confidence in the national currency, to set up a mechanism of mortgage lending by state banks. Value/originality. The data was obtained as a result of thorough calculations possible not only to identify problems but also to identify their solutions that will enable the Ukrainian banking system to reach a new stage in its development, and the credit market to make an essential source of economic

  7. Results of a customer-based, post-market surveillance survey of the HeRO access device.

    Science.gov (United States)

    Fusselman, Maureen

    2010-08-01

    In order to supplement post-market surveillance data on the HeRO vascular access device, a non-scientific customer survey was conducted to obtain quantitative data from dialysis providers caring for patients implanted with the device. Dialysis nurses involved in the care of HeRO patients were contacted in order to obtain post-implant device performance information for 10% of patients implanted with the device at the time of the survey. Thirty-eight dialysis units with a total of 65 HeRO patients participated in the survey. The total duration of HeRO device use was 348.4 months with an average use of 5.4 months. Thirty-eight of the 65 HeRO patients (58.5%) were reported to not have experienced any performance issues. There were 28 device performance incidents reported for the remaining 27 patients included in the survey. Occlusion was the single most commonly reported device-related performance issue with 18 patients (27.7%) experiencing 25 occlusive episodes. The majority of the patients who had an occlusion (66.7%) only experienced one occlusive event. Infections occurred in 4 patients (6.2%) with an overall infection rate of 0.38 per 1,000 patient days. Post-market clinical experience during the first 18 months of commercialization of the HeRO device were in line with expectations based on the results from initial clinical studies with the device. Device occlusion remains the most commonly reported performance issue with the reported rate in this survey less than that which was reported in earlier published studies with the device.

  8. Post-purchase cognitive dissonance:Evidence from the mobile phone market

    OpenAIRE

    Graff, Jens; Sophonthummapharn, Kittipong; Parida, Vinit

    2012-01-01

    This article investigates whether cognitive dissonance exists in the post-purchase phase in the mobile phone industry. It asks if mobile phone users are fully satisfied since they are usually overloaded with information during the purchasing period. Three dimensions of dissonance were measured in 283 university students. The results provide interesting insights. The major differences between the high and low dissonance groups are being influenced by other people’s opinions, difficulty in find...

  9. Post-marketing withdrawal of analgesic medications because of adverse drug reactions: a systematic review.

    Science.gov (United States)

    Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

    2018-01-01

    Many analgesics have been withdrawn from the market because of adverse drug reactions. Controversy still surrounds the use of some approved analgesics for pain management. However, the trends and reasons for withdrawal of analgesics when harms are attributed to their use have not been systematically assessed. Areas covered: We conducted searches in PubMed; Embase; Google Scholar; clinicaltrials.gov; WHO databases of withdrawn products; websites of the European Medicines Agency, the US Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency; Meyler's Side Effects of Drugs; Stephens' Detection of New Adverse Drug Reactions; the Pharmaceutical Manufacturing Encyclopedia; and the Merck Index. We included licensed analgesics that were withdrawn after marketing because of adverse reactions between 1950 and March 2017. We excluded herbal products, non-human medicines, and non-prescription medicines. We used the Oxford Centre for Evidence Based Medicine criteria to document the levels of evidence, and chi-squared tests to compare withdrawal patterns across geographical regions. Expert opinion: Pharmacovigilance systems in low-resource settings should be strengthened. Greater co-ordination across regulatory authorities in assessing and interpreting the benefit-harm balance of new analgesics should be encouraged. Future reporting of harms in clinical trials of analgesics should follow standardized guidelines.

  10. Post-hit dynamics of price limit hits in the Chinese stock markets

    Science.gov (United States)

    Wu, Ting; Wang, Yue; Li, Ming-Xia

    2017-01-01

    Price limit trading rules are useful to cool off traders short-term trading mania on individual stocks. The price dynamics approaching the limit boards are known as the magnet effect. However, the price dynamics after opening price limit hits are not well investigated. Here, we provide a detailed analysis on the price dynamics after the hits of up-limit or down-limit is open based on all A-share stocks traded in the Chinese stock markets. A "W" shape is found in the expected return, which reveals high probability of a continuous price limit hit on the following day. We also find that price dynamics after opening limit hits are dependent on the market trends. The time span of continuously hitting the price limit is found to an influence factor of the expected profit after the limit hit is open. Our analysis provides a better understanding of the price dynamics around the limit boards and contributes potential practical values for investors.

  11. Homeopathic drug therapy. Homeopathy in Chikungunya Fever and Post-Chikungunya Chronic Arthritis: an observational study.

    Science.gov (United States)

    Wadhwani, Gyandas G

    2013-07-01

    To observe the effect of homeopathic therapy in Chikungunya Fever (CF) and in Post-Chikungunya Chronic Arthritis (PCCA) in a primary health care setting. A prospective observational study was conducted at Delhi Government Homeopathic Dispensary, Aali Village, New Delhi, India, for a period of 6 months, from 1st October 2010 to 31st March 2011. 126 patients (75 CF, 51 PCCA) were enrolled based on predefined inclusion criteria. A single homeopathic medicine was prescribed for each patient after case taking with the help of Materia Medica and/or Repertory. Results were evaluated on the basis of visual analogue scale and symptom scores. Complete recovery was seen in 84.5% CF cases in a mean time of 6.8 days. 90% cases of PCCA recovered completely in a mean time of 32.5 days. Homeopathic therapy may be effective in CF and PCCA. A randomized controlled trial should be considered. Copyright © 2013 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  12. HUBBLE SPACE TELESCOPE AND GROUND-BASED OBSERVATIONS OF V455 ANDROMEDAE POST-OUTBURST

    Energy Technology Data Exchange (ETDEWEB)

    Szkody, Paula; Mukadam, Anjum S.; Brown, Justin; Funkhouser, Kelsey [Department of Astronomy, University of Washington, Box 351580, Seattle, WA 98195 (United States); Gänsicke, Boris T. [Department of Physics, University of Warwick, Coventry CV4 7AL (United Kingdom); Henden, Arne [AAVSO, 49 Bay State Road, Cambridge, MA 02138 (United States); Sion, Edward M. [Department of Astronomy and Astrophysics, Villanova University, Villanova, PA 19085 (United States); Townsley, Dean M. [Department of Physics and Astronomy, University of Alabama, Tuscaloosa, AL 35487 (United States); Christian, Damian [Department of Physics and Astronomy, California State University, Northridge, CA 91330 (United States); Falcon, Ross E. [Department of Astronomy, University of Texas, Austin, TX 78712 (United States); Pyrzas, Stylianos, E-mail: szkody@astro.washington.edu, E-mail: anjum@astro.washington.edu, E-mail: boris.gaensicke@warwick.ac.uk, E-mail: arne@aavso.org, E-mail: edward.sion@villanova.edu, E-mail: Dean.M.Townsley@ua.edu, E-mail: damian.christian@csun.edu, E-mail: cylver@astro.as.utexas.edu, E-mail: stylianos.pyrzas@gmail.com [Instituto de Astronomia, Universidad Catolica del Norte, Avenida Angamos 0619, Antofagasta (Chile)

    2013-09-20

    Hubble Space Telescope spectra obtained in 2010 and 2011, 3 and 4 yr after the large amplitude dwarf nova outburst of V455 And, were combined with optical photometry and spectra to study the cooling of the white dwarf, its spin, and possible pulsation periods after the outburst. The modeling of the ultraviolet (UV) spectra shows that the white dwarf temperature remains ∼600 K hotter than its quiescent value at 3 yr post-outburst, and still a few hundred degrees hotter at 4 yr post-outburst. The white dwarf spin at 67.6 s and its second harmonic at 33.8 s are visible in the optical within a month of outburst and are obvious in the later UV observations in the shortest wavelength continuum and the UV emission lines, indicating an origin in high-temperature regions near the accretion curtains. The UV light curves folded on the spin period show a double-humped modulation consistent with two-pole accretion. The optical photometry 2 yr after outburst shows a group of frequencies present at shorter periods (250-263 s) than the periods ascribed to pulsation at quiescence, and these gradually shift toward the quiescent frequencies (300-360 s) as time progresses past outburst. The most surprising result is that the frequencies near this period in the UV data are only prominent in the emission lines, not the UV continuum, implying an origin away from the white dwarf photosphere. Thus, the connection of this group of periods with non-radial pulsations of the white dwarf remains elusive.

  13. Secrets, Trauma, and the Memory Market (or the return of the repressed in recent Argentine post-dictatorship cultural production

    Directory of Open Access Journals (Sweden)

    Silvia R Tandeciarz

    2012-04-01

    Full Text Available Since the end of the last Argentine Dictatorship (1976-1983, a number of feature-length films have engaged in the public debate over the legacies of state terrorism. El secreto de sus ojos (2009, Argentina's most recent Oscar winner, is the latest to do so, exploring the effects of more than a decade of impunity on those who lost their loved ones. Suggesting that restoration of a justice system that works can lead to the restoration of full civic engagement in a healthy body politic, the film raises important questions about citizenship and belonging in a post-national era. This essay explores the film's phenomenal success in the global memory market to illuminate what remains at stake in contemporary narratives of reconciliation.

  14. From Reciprocal Social Networks to Action Groups for Market Exchange: “Spontaneous Privatization” in Post-Communist Hungary

    Directory of Open Access Journals (Sweden)

    Larissa Lomnitz

    2011-12-01

    Full Text Available Following previous research on the significance that social networks have had for the economic and social survival of Latin American and Soviet state-employed middle classes, this paper explores the role of social networks (connections on the process of privatization and market liberalization of Post-Communist Hungary. Based on former academic studies and on field research conducted for several months in Budapest, we will try to show that social networks are central intermediary structures on which individuals and groups construct solutions that allow them to cope with the deficiencies resulting from the formal system. From this perspective we will explore the importance of manager’s connections in the first period of the Hungarian privatization process known as “spontaneous privatization”.

  15. Observed Minimum Illuminance Threshold for Night Market Vendors in Kenya who use LED Lamps

    Energy Technology Data Exchange (ETDEWEB)

    Johnstone, Peter; Jacobson, Arne; Mills, Evan; Radecsky, Kristen

    2009-03-21

    Creation of light for work, socializing, and general illumination is a fundamental application of technology around the world. For those who lack access to electricity, an emerging and diverse range of LED based lighting products hold promise for replacing and/or augmenting their current fuel-based lighting sources that are costly and dirty. Along with analysis of environmental factors, economic models for total cost-ofownership of LED lighting products are an important tool for studying the impacts of these products as they emerge in markets of developing countries. One important metric in those models is the minimum illuminance demanded by end-users for a given task before recharging the lamp or replacing batteries. It impacts the lighting service cost per unit time if charging is done with purchased electricity, batteries, or charging services. The concept is illustrated in figure 1: LED lighting products are generally brightest immediately after the battery is charged or replaced and the illuminance degrades as the battery is discharged. When a minimum threshold level of illuminance is reached, the operational time for the battery charge cycle is over. The cost to recharge depends on the method utilized; these include charging at a shop at a fixed price per charge, charging on personal grid connections, using solar chargers, and purchasing dry cell batteries. This Research Note reports on the observed"charge-triggering" illuminance level threshold for night market vendors who use LED lighting products to provide general and task oriented illumination. All the study participants charged with AC power, either at a fixed-price charge shop or with electricity at their home.

  16. E-cigarette marketing in UK stores: an observational audit and retailers’ views

    Science.gov (United States)

    Eadie, D; Stead, M; MacKintosh, A M; MacDonald, L; Purves, R; Pearce, J; Tisch, C; van der Sluijis, W; Amos, A; MacGregor, A; Haw, S

    2015-01-01

    Objectives To explore how e-cigarettes are being promoted at point of sale in the UK and how retailers perceive market trends. Setting Fixed retail outlets subject to a ban on the display of tobacco products. Participants Observational audit of all stores selling tobacco products (n=96) in 4 Scottish communities, conducted over 2 waves 12 months apart (2013–2014), and qualitative interviews with small retailers (n=25) in 4 matched communities. Primary and secondary outcome measures The audit measured e-cigarette display characteristics, advertising materials and proximity to other products, and differences by area-level disadvantage. Interviews explored retailers’ perceptions of e-cigarette market opportunities and risks, and customer responses. Results The number of e-cigarette point-of-sale display units and number of brands displayed increased between waves. E-cigarettes were displayed close to products of interest to children in 36% of stores. Stores in more affluent areas were less likely to have external e-cigarette advertising than those in deprived areas. Although e-cigarettes delivered high profit margins, retailers were confused by the diversity of brands and products, and uncertain of the sector's viability. Some customers were perceived to purchase e-cigarettes as cessation aids, and others, particularly low-income smokers, as a cheaper adjunct to conventional tobacco. Conclusions E-cigarette point-of-sale displays and number of brands displayed increased over 12 months, a potential cause for concern given their lack of regulation. Further scrutiny is needed of the content and effects of such advertising, and the potentially normalising effects of placing e-cigarettes next to products of interest to children. PMID:26362665

  17. E-cigarette marketing in UK stores: an observational audit and retailers' views.

    Science.gov (United States)

    Eadie, D; Stead, M; MacKintosh, A M; MacDonald, L; Purves, R; Pearce, J; Tisch, C; van der Sluijis, W; Amos, A; MacGregor, A; Haw, S

    2015-09-11

    To explore how e-cigarettes are being promoted at point of sale in the UK and how retailers perceive market trends. Fixed retail outlets subject to a ban on the display of tobacco products. Observational audit of all stores selling tobacco products (n=96) in 4 Scottish communities, conducted over 2 waves 12 months apart (2013-2014), and qualitative interviews with small retailers (n=25) in 4 matched communities. The audit measured e-cigarette display characteristics, advertising materials and proximity to other products, and differences by area-level disadvantage. Interviews explored retailers' perceptions of e-cigarette market opportunities and risks, and customer responses. The number of e-cigarette point-of-sale display units and number of brands displayed increased between waves. E-cigarettes were displayed close to products of interest to children in 36% of stores. Stores in more affluent areas were less likely to have external e-cigarette advertising than those in deprived areas. Although e-cigarettes delivered high profit margins, retailers were confused by the diversity of brands and products, and uncertain of the sector's viability. Some customers were perceived to purchase e-cigarettes as cessation aids, and others, particularly low-income smokers, as a cheaper adjunct to conventional tobacco. E-cigarette point-of-sale displays and number of brands displayed increased over 12 months, a potential cause for concern given their lack of regulation. Further scrutiny is needed of the content and effects of such advertising, and the potentially normalising effects of placing e-cigarettes next to products of interest to children. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  18. Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post-marketing study (J-STEP/EL Study).

    Science.gov (United States)

    Utsunomiya, Kazunori; Shimmoto, Naoki; Senda, Masayuki; Kurihara, Yuji; Gunji, Ryoji; Fujii, Shoko; Kakiuchi, Seigo; Fujiwara, Hisataka; Kameda, Hiroyuki; Tamura, Masahiro; Kaku, Kohei

    2017-11-01

    Although sodium-glucose cotransporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, they are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing study of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus. This was a prospective, observational and multicenter post-marketing study carried out in the context of routine clinical practice. The study included all type 2 diabetes patients aged ≥65 years who started treatment with tofogliflozin during the first 3 months after its launch on 23 May 2014. Of 1,535 patients registered, 1,507 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis. A total of 270 of 1,507 patients (17.92%) had at least one adverse drug reaction to tofogliflozin. The incidences of adverse drug reactions of special interest, namely, polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, hypoglycemia and skin disorders were 2.92, 3.85, 2.06, 1.33, 1.06 and 2.39%, respectively. Among those patients evaluable for clinical effectiveness, the mean change in glycated hemoglobin and bodyweight from baseline to last visit was -0.46% (P < 0.0001) and -2.71 kg (P < 0.0001), respectively. The present study showed that the incidence of adverse drug reactions to tofogliflozin in this study of elderly patients aged ≥65 years differed little from the incidence in the preapproval clinical trials. It was shown that tofogliflozin significantly decreased glycated hemoglobin levels. © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  19. An observational study of patient care outcomes sensitive to handover quality in the Post-Anaesthetic Care Unit.

    Science.gov (United States)

    Lillibridge, Nichole; Botti, Mari; Wood, Beverley; Redley, Bernice

    2017-12-01

    To identify patient care outcome indicators sensitive to the quality of interprofessional handover between the anaesthetist and the Post-Anaesthetic Care Unit nurse. The relationship between interprofessional clinical handover when patients are transferred from the operating theatre to the Post-Anaesthetic Care Unit and patient outcomes of subsequent patient care delivery is not well understood. Naturalistic, exploratory descriptive design using observation. Observations of 31 patient journeys through Post-Anaesthetic Care Units across three public and private hospitals. Characteristics of interprofessional handover on arrival in the Post-Anaesthetic Care Unit, the trajectory of patient care activities in Post-Anaesthetic Care Unit and patient outcomes were observed. Of the 821 care activities observed across 31 "patient journeys" in the Post-Anaesthetic Care Unit, observations (assessments and vital signs) (52.5 %), communication (15.8 %) and pain management (assessment of pain and analgesic administration) (10.3%) were most common. Examination of patterns in handover communications and subsequent trajectories of patient care activities revealed three patient trajectory typologies and two patient outcome indicators expected to be sensitive to the quality of interprofessional handover communication in the Post-Anaesthetic Care Unit: pain on discharge from the Post-Anaesthetic Care Unit and timely response to clinical deterioration. An additional process indicator, seeking missing information, was also identified. Patient's pain on discharge from Post-Anaesthetic Care Unit, escalation of care in response to early signs of deterioration and the need for nurses to seek out missing information to deliver care are indicators expected to be sensitive to the quality of interprofessional handover communication in the Post-Anaesthetic Care Unit. Future research should test these indicators. Patient outcomes sensitive to the quality of interprofessional handover on patient

  20. Plasma glutamine levels before cardiac surgery are related to post-surgery infections; an observational study

    Directory of Open Access Journals (Sweden)

    Hanneke Buter

    2016-11-01

    Full Text Available Abstract Background A low plasma glutamine level was found in 34% of patients after elective cardiothoracic surgery. This could be a result of the inflammation caused by surgical stress or the use of extracorporeal circulation (ECC. But it is also possible that plasma glutamine levels were already lowered before surgery and reflect an impaired metabolic state and a higher likelihood to develop complications. In the present study plasma glutamine levels were measured before and after cardiac surgery and we questioned whether there is a relation between plasma glutamine levels and duration of ECC and the occurrence of postoperative infections. Methods We performed a single-centre prospective, observational study in a closed-format, 20-bed, mixed ICU in a tertiary teaching hospital. We included consecutive patients after elective cardiac surgery with use of extracorporeal circulation. Blood samples were collected on the day prior to surgery and at admission on the ICU. The study was approved by the local Medical Ethics Committee (Regional Review Committee Patient-related Research, Medical Centre Leeuwarden, nWMO 115, April 28th 2015. Results Ninety patients were included. Pre-operative plasma glutamine level was 0.42 ± 0.10 mmol/l and post-operative 0.38 ± 0.09 mmol/l (p < 0.001. There was no relation between duration of extracorporeal circulation or aortic occlusion time and changes in plasma glutamine levels. A logistic regression analysis showed a significant correlation between the presence of a positive culture during the post-operative course and pre-operative plasma glutamine levels (p = 0.04. Conclusion Plasma glutamine levels are significantly lower just after cardiac surgery compared to pre-operative levels. We did not find a relation between the decrease in plasma glutamine levels and the duration of extracorporeal circulation or aortic clamp time. There was a correlation between pre-operative plasma glutamine levels

  1. Development of post-harvest protocol of okra for export marketing.

    Science.gov (United States)

    Dhall, R K; Sharma, S R; Mahajan, B V C

    2014-08-01

    The study was carried out on the harvesting and handling methods of okra with the objective to maintain the best quality of pods from harvesting to end consumer especially for export marketing. For that purpose okra cv. 'Punjab-8' pods were harvested with minimum handling (least injuries to the pubescence on the ridges of pod) and normal handling (no safety taken to prevent injuries on pods). Pods were precooled at 15 ± 1ºC, 90-95% RH; jumble packed in the CFB boxes of 2.0 Kg capacity and than stored at 8 ± 1ºC, 90-95% RH. The quality parameters of okra namely texture, chlorophyll content, physiological loss in weight, rotting percentage and general appearance were studied. The pods harvested with minimum handling and field packaging can retain their green colour, crisp texture (maximum force to puncture pod = 500.2 g) with minimum rotting (3.0%) and physiological loss in weight (15.8%) and good appearance upto 13 days of cold storage whereas normal handled pods can be stored upto 5 days at 8 ± 1ºC, 90-95% RH and thereafter lost their general appearance on the 7th day of storage and were discarded. Therefore, in order to maintain high quality of okra from harvesting to the final destination (consumer), the okra pods should be harvested with minimum handling followed by field packaging in CFB boxes.

  2. [Post-marketing surveillance of antibacterial activities of cefozopran against various clinical isolates--I. Gram-positive bacteria].

    Science.gov (United States)

    Igari, Jun; Oguri, Toyoko; Hiramatsu, Nobuyoshi; Akiyama, Kazumitsu; Koyama, Tsuneo

    2003-10-01

    As a post-marketing surveillance, the in vitro antibacterial activities of cefozopran (CZOP), an agent of cephems, against various clinical isolates were yearly evaluated and compared with those of other cephems, oxacephems, penicillins, and carbapenems. Changes in the bacterial susceptibility for CZOP were also evaluated with the resistance ratio calculated with breakpoint MIC. Sixteen species (2,363 strains) of Gram-positive bacteria were isolated from the clinical materials annually collected from 1996 to 2001, and consisted of methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus epidermidis (MSSE), methicillin-resistant Staphylococcus epidermidis (MRSE), Staphylococcus haemolyticus, Staphylococcus saprophyticus, Enterococcus faecalis, Enterococcus faecium, Enterococcus avium, Streptococcus pyogenes, Streptococcus agalactiae, penicillin-susceptible Streptococcus pneumoniae (PSSP), penicillin-intermediate resistant S. pneumoniae (PISP), penicillin-resistant S. pneumoniae (PRSP), Streptococcus milleri group and Peptostreptococcus spp. The antibacterial activity of CZOP either against MSSA or MSSE was preferable (MIC90: 2 or 0.5 micrograms/mL) and comparable to those of other cephems. CZOP was also effective on MRSE (MIC90: 16 micrograms/mL) but not on MRSA. CZOP and other cephems had low antibacterial activity against S. haemolyticus (MIC90: 64 micrograms/mL). The antibacterial activity of CZOP against S. saprophyticus was comparable to or higher than those of other cephems, but the MIC90 of CZOP in 2001 was higher than those in 1996-2000 (32 vs 1-2 micrograms/mL). The antibacterial activity of CZOP against E. faecalis was comparable to that of cefpirome (CPR; MIC90: 16 micrograms/mL) and higher than those of other cephems. No antibacterial activity of CZOP against E. faecium and E. avium was observed, like other drugs. The antibacterial activity of CZOP against S. pyogenes

  3. The market value of freshness: observations from the swordfish and blue shark longline fishery

    NARCIS (Netherlands)

    Ishimura, G.; Bailey, M.L.

    2013-01-01

    One important component in determining the market value of fish is freshness, essentially the time period from capture to consumer. By shortening the time from harvest to landing, freshness can be improved and thus the market value may increase. The opportunistic nature of the marine capture

  4. The relationship between in-store marketing and observed sales for organic versus fair trade products

    NARCIS (Netherlands)

    Herpen, van E.; Nierop, van J.E.M.; Sloot, L.M.

    2012-01-01

    To stimulate sales of sustainable products, such as organic and fair trade products, retailers need to know whether their in-store instruments effectively enhance market shares. This study uses sales data and a multilevel modeling approach to explain the market shares of sustainable products

  5. The relationship between in-store marketing and observed sales for organic versus fair trade products

    NARCIS (Netherlands)

    van Herpen, Erica; van Nierop, Erjen; Sloot, Laurens

    To stimulate sales of sustainable products, such as organic and fair trade products, retailers need to know whether their in-store instruments effectively enhance market shares. This study uses sales data and a multilevel modeling approach to explain the market shares of sustainable products

  6. Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience.

    Science.gov (United States)

    Gama, Helena; Vieira, Mariana; Costa, Raquel; Graça, Joana; Magalhães, Luís M; Soares-da-Silva, Patrício

    2017-12-01

    Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance. We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and serious adverse events were analyzed. The global safety database of eslicarbazepine acetate was analyzed for all cases from post-marketing surveillance from 1 October, 2009 to 21 October, 2015. From a pooled analysis of four phase III studies, it was concluded that the incidence of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and adverse drug reactions were dose dependent. Dizziness, somnolence, headache, and nausea were the most common treatment-emergent adverse events (≥10% of patients) and the majority were of mild-to-moderate intensity. No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients. Hyponatremia was classified as a possibly related treatment-emergent adverse event in phase III studies (1.2%); however, after 6 years of post-marketing surveillance it represents the most frequently (10.2%) reported adverse drug reaction, with more than half of these cases occurring with eslicarbazepine acetate at

  7. Observations of marketing on food packaging targeted to youth in retail food stores.

    Science.gov (United States)

    Grigsby-Toussaint, Diana S; Moise, Imelda K; Geiger, Sarah D

    2011-09-01

    There is growing evidence that exposure to food marketing influences dietary preferences among youth. Few studies exploring this association, however, have focused on the retail food store environment where families negotiate the influence of food and beverage marketing on purchasing practices. Consequently, we sought to examine: (i) the extent to which foods marketed on the internet and television to youth are also available and marketed in retail food stores, and (ii) whether differences exist in the marketing practices across store types and by neighborhood racial composition. In 2008, a cross-sectional survey of 118 food stores was conducted in four Midwestern cities in the United States. Results showed that 82% of stores assessed carried items commonly marketed to youth via television or the internet. The items most likely to have some type of marketing technique were noncarbonated drinks (97.7%), fruit and cereal bars (76.9%), and soda (62.2%). Grocery stores were significantly more likely than convenience stores to have marketing for breads and pastries (34.6% vs. 17.9%), breakfast cereals (52.0% vs. 22.9%), cookies and crackers (54.2% vs. 25.3%), dairy (70.8% vs. 42.7%), and ice cream (23.8% vs. 9.8%). Stores located in black neighborhoods were significantly more likely to have marketing, in comparison to white neighborhoods, for breads and pastries (35.7% vs. 17.1%), breakfast cereals (44.4% vs. 25.0%), and cookies and crackers (48.1% vs. 26.3%). Our results highlight the importance of examining food marketing techniques in the retail food store environment, where visual cues from television and the internet may be reinforced.

  8. Using Research Case Studies in eCommerce Marketing Courses: Customer Satisfaction at Point-of-Purchase and Post-Purchase

    Science.gov (United States)

    Nawi, Noorshella Che; Fong, Michelle; Tatnall, Arthur

    2014-01-01

    This paper describes a research case study of Internet apparel marketing by small businesses in Malaysia which can beneficially be included in postgraduate business courses for understanding the importance of measuring customer satisfaction at point-of-purchase and post-purchase in online purchases. The sample size in this research is 154…

  9. Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Government & Policy-Makers

    Science.gov (United States)

    Wheelahan, Leesa; Buchanan, John; Yu, Serena

    2015-01-01

    This summary brings together the relevant key findings for government and policy-makers from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between vocational education and…

  10. Vocations: The Link between Post-Compulsory Education and the Labour Market. What the Research Says For... Tertiary Education Providers & School Educators

    Science.gov (United States)

    Wheelahan, Leesa; Buchanan, John; Yu, Serena

    2015-01-01

    This summary brings together the relevant key findings for tertiary education providers and school educators from the research program "Vocations: The Link between Post-Compulsory Education and the Labour Market." The program was comprised of three different strands: (1) pathways from VET in Schools, (2) pathways within and between…

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

    Science.gov (United States)

    Blandizzi, Corrado; Galeazzi, Mauro; Valesini, Guido

    2018-02-01

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

  12. Post-marketing access to orphan drugs: a critical analysis of health technology assessment and reimbursement decision-making considerations

    Directory of Open Access Journals (Sweden)

    Iskrov G

    2014-01-01

    Full Text Available Georgi Iskrov, Rumen Stefanov Department of Social Medicine and Public Health, Medical University of Plovdiv, Plovdiv, Bulgaria Abstract: This study aims to explore the current rationale of post-marketing access to orphan drugs. As access to orphan medicinal products depends on assessment and appraisal by health authorities, this article is focused on health technology assessment (HTA and reimbursement decision-making considerations for orphan drugs. A critical analysis may identify important factors that could predetermine the combined outcomes of these two processes. Following this objective, an analytical framework was developed, comprising three overlaying issues: to outline what is currently done and what needs to be done in the field of HTA of orphan drugs, to synthesize important variables relevant to the reimbursement decision-making about orphan drugs, and to unveil relationships between theory and practice. Methods for economic evaluation, cost-effectiveness threshold, budget impact, uncertainty of evidence, criteria in reimbursement decision-making, and HTA research agenda are all explored and discussed from an orphan drug perspective. Reimbursement decision-making for orphan drugs is a debate of policy priorities, health system specifics, and societal attitudes. Health authorities need to pursue a multidisciplinary analysis on a range of criteria, ensuring an explicit understanding of the trade-offs for decisions related to eligibility for reimbursement. The only reasonable way to accept a higher valuation of orphan drug benefits is if these are demonstrated empirically. Rarity means that the quality of orphan drug evidence is not the same as for conventional therapies. Closing this gap is another crucial point for the timely access to these products. The generation of evidence goes far beyond pre-market authorization trials and requires transnational cooperation and coordination. Early constructive dialogue among orphan drug

  13. Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review.

    Science.gov (United States)

    Polisena, Julie; Forster, Alan J; Cimon, Karen; Rabb, Danielle

    2013-10-10

    Post-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PubMed for medical literature on PMS for PTCA catheters in patients with CAD published between January 2007 and July 2012. We also searched the grey literature. This review included 11 studies. The in-hospital adverse events reported were individual cases of myocardial infarction and hematoma. In studies of patients with coronary perforation, more patients with balloon angioplasty were identified compared with patients who required stenting. Our systematic review illustrates that the volume and quality of PMS studies associated with the use of PTCA catheters in patients with CAD are low in the published and grey literature, and may not be useful sources of information for decisions on safety. In most studies, the objectives were not to monitor the long-term safety of the use of PTCA catheters in clinical practice. Future studies can explore the strengths and limitations of PMS databases administered by regulatory authorities.

  14. Reevaluation of the post-marketing safety of Shuxuening injection based on real-world and evidence-based evaluations

    Directory of Open Access Journals (Sweden)

    Wang C

    2018-04-01

    Full Text Available Can Wang,1,2 Qing-ping Shi,1,2 Feng Ding,2 Xiao-dong Jiang,1,2 Wei Tang,3 Mei-Ling Yu,1,2 Jian-Hua Zhu2 1Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical College, Bengbu, People’s Republic of China; 2Faculty of Pharmacy, Bengbu Medical College, Bengbu, People’s Republic of China; 3Department of Pharmacy, Huaiyuan County Hospital of TCM in Anhui, Bengbu, People’s Republic of China Aim: To evaluate the factors influencing suspected hypersensitivity and adverse systemic reactions after Shuxuening injection and to provide innovative ideas and methods for the reevaluation of post-marketing safety of Shuxuening.Methods: This study used a prospective, nested case–control study design, combined with a prescription sequence analysis design method. It classified patients who exhibited trigger signals after administration of Shuxuening injection as suspected allergic patients and made comparisons with patients who did not report adverse effects to calculate the correlation between relevant risk factors and suspected allergic reactions. Randomized controlled studies and cohort studies of the adverse drug reaction (ADR of Shuxuening were performed using a computer database. Data retrieval was carried out by the foundation governing the individual database. Meta-analysis was performed by using R3.2.3 software to evaluate the ADRs of Shuxuening.Results: The results of real-world study showed that administration of Shuxuening in combination with potassium aspartate and magnesium, atorvastatin calcium, Shengmai injection, pantoprazole sodium, or high-dose medication was a risk factor for suspected allergic reactions. Meta-analysis showed that the incidence of adverse events was 5.84% (95% CI 0.0499; 0.0674, and serious adverse reaction rate was 4.36% (95% CI 0.0188; 0.0760 when Shuxuening was used in combination with these drugs. The incidence of allergic reaction was also influenced by the vehicle, duration of treatment, single

  15. Long-term post-marketing surveillance of mizoribine for the treatment of lupus nephritis: Safety and efficacy during a 3-year follow-up

    Directory of Open Access Journals (Sweden)

    Nobuyuki Yagi

    2014-05-01

    Full Text Available Objective: To determine the safety and efficacy of long-term use of mizoribine by undertaking a 3-year post-marketing surveillance study. Methods: Subjects were all lupus nephritis patients newly treated with mizoribine between 1 October 2003 and 30 September 2005 at contracted study sites. Results: Mizoribine was administered to 881 lupus nephritis patients in the safety analysis set consisting of 946 patients recruited from 281 contracted study sites after satisfying the eligibility criteria. There were 301 events of adverse drug reactions that were observed in 196 (20.7% of the 946 subjects. There were 34 events of serious adverse drug reactions in 31 patients (3.2%. No deterioration in hematological and biochemical test values was observed, but immunological testing showed significant improvements in C3, CH50, and anti-DNA antibody titers. The negative rate of proteinuria also increased over time. The median steroid dosage was 15 mg/day at the commencement of treatment, but was reduced to 10 mg/day at 12 months and 8 mg/day at 36 months. Conclusion: The findings of the 3-year long-term drug use surveillance study indicated that mizoribine can be used over the long term with relatively few adverse drug reactions, suggesting its suitability for use in maintenance drug therapy.

  16. Effectiveness and safety of dydrogesterone in regularization of menstrual cycle: a post-marketing study.

    Science.gov (United States)

    Trivedi, Nilesh; Chauhan, Naveen; Vaidya, Vishal

    2016-08-01

    Oral administration of dydrogesterone during second half of menstrual cycle has been shown to reduce menstrual irregularities. This prospective, observational study aimed to determine continued effectiveness of dydrogesterone (prescribed between 1 and 6 cycles or longer) in menstrual cycle regularization in Indian women aged ≥18 years with irregular menstrual cycle for at least 3 months. Those achieving regular cycles (21 to 35 days, inclusive) during treatment were followed up for 6 months after cessation of dydrogesterone treatment. Of the 910 women completing dydrogesterone treatment, 880 (96.7%) achieved cycle regularization (p<0.0001 for 90% success rate) at end of treatment (EOT). Of the 788 subjects available for follow up at 6 months, 747 (94.8%) reported cycle regularity (p<0.0001 for 90% success rate). At EOT, the mean cycle duration reduced by 16.14 (±24.04) days and mean amount of menstrual bleeding decreased by 0.45 (±1.20) pads/day. While five subjects reported worst pain at baseline, none experienced it at EOT. One serious adverse event (appendicitis) and three non-serious adverse events were reported. Dydrogesterone regularizes and improves the duration of the menstrual cycle, reduces the amount of bleeding, relieves menstrual pain and prevents relapse of irregular cycles at six months after discontinuation of treatment.

  17. LISA observations of supermassive black holes: Parameter estimation using full post-Newtonian inspiral waveforms

    International Nuclear Information System (INIS)

    Trias, Miquel; Sintes, Alicia M.

    2008-01-01

    We study parameter estimation of supermassive black hole binary systems in the final stage of inspiral using the full post-Newtonian gravitational waveforms. We restrict our analysis to systems in circular orbit with negligible spins, in the mass range 10 8 M · -10 5 M · , and compare the results with those arising from the commonly used restricted post-Newtonian approximation. The conclusions of this work are particularly important with regard to the astrophysical reach of future Laser Interferometer Space Antenna measurements. Our analysis clearly shows that modeling the inspiral with the full post-Newtonian waveform, not only extends the reach to higher mass systems, but also improves in general the parameter estimation. In particular, there are remarkable improvements in angular resolution and distance measurement for systems with a total mass higher than 5x10 6 M · , as well as a large improvement in the mass determination

  18. Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.

    Science.gov (United States)

    Kwok, Charlotte S; Johnson, Emily L; Krauss, Gregory L

    2017-11-01

    Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients. AED extension studies evaluate treatment retention, drug tolerability, and drug safety during individualized treatment with flexible dosing and thus provide information not available in rigid pivotal trials. Patient retention in the studies ranged from 75 to 80% at 1 year and from 36 to 68% at 2-year treatment intervals. Safety findings were generally similar to those of pivotal trials, with no major safety risks identified and with several specific adverse drug effects, such as hyponatremia, reported. The third-generation AEDs, some through new mechanisms and others with improved tolerability compared to related AEDs, provide new options in efficacy and tolerability.

  19. Risk Management Post-Marketing Surveillance for the Abuse of Medications Acting on the Central Nervous System: Expert Panel Report

    Science.gov (United States)

    Johanson, Chris-Ellyn; Balster, Robert L.; Henningfield, Jack E.; Schuster, Charles R.; Anthony, James C.; Barthwell, Andrea G.; Coleman, John J.; Dart, Richard C.; Gorodetzky, Charles W.; O’Keeffe, Charles; Sellers, Edward M.; Vocci, Frank; Walsh, Sharon L.

    2010-01-01

    The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October, 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and eleven recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized. PMID:19783383

  20. Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis.

    Science.gov (United States)

    Takeuchi, Tsutomu; Kawai, Shinichi; Yamamoto, Kazuhiko; Harigai, Masayoshi; Ishida, Kota; Miyasaka, Nobuyuki

    2014-01-01

    A post-marketing surveillance (PMS) program was implemented to assess the safety and effectiveness of tacrolimus (TAC) in Japanese rheumatoid arthritis (RA) patients and to identify risk factors related to adverse drug reactions (ADRs). Patients were registered centrally and monitored for all adverse events (AEs) for 24 weeks. Effectiveness was evaluated using the Disease Activity Score 28-CRP (DAS28-CRP). Data from 3,172 patients (mean age 62.2 years) were evaluated in the safety analysis. Of the safety population, 78.5 %were female and 25.9 % were in Steinbrocker's functional class 3 or 4. TAC was prescribed as monotherapy in 52.5 % and the most common concomitant disease modifying antirheumatic drug (DMARD) was methotrexate, used in 28.9 % of the patients. The incidence of AEs, serious AEs (SAEs), ADRs and serious ADRs were 41.2, 6.4, 36.0, and 4.9 %, respectively. The most frequent serious ADR category was infections and infestations. Age ≥ 65 years, concurrent renal dysfunction, and concurrent diabetes mellitus were identified as significant risk factors for ADR. Based on EULAR response criteria, 65.4 % of the patients showed moderate or good response. The results demonstrate that TAC is well tolerated by Japanese patients with active RA, including those receiving concomitant methotrexate, in the real world.

  1. Safety and efficacy of adapalene gel 0.1% in acne vulgaris: Results of a post-marketing surveillance study

    Directory of Open Access Journals (Sweden)

    Percy S

    2003-07-01

    Full Text Available Introduction: Adapalene is a novel retinoid indicated for the topical treatment of acne vulgaris. The drug was introduced in India in 2001. Aims: A post-marketing surveillance study was conducted to assess the safety and efficacy of adapalene gel 0.1% when used as monotherapy or in combination with other anti-acne agents in Indian patients of acne vulgaris. Material and Methods: A 12-week, multicentre, open-label, non-comparative study involving 571 patients from 21 centers across India was conducted between January and September of 2002. Concomitant prescription of other anti-acne drugs was permitted, if needed. Results: Of the 571 patients, 441 completed the treatment as per protocol. At the end of therapy, 96.3% of patients showed an improvement in their acne from baseline, with greater than 75% improvement seen in two-thirds of patients. Adverse events were reported in 24% of the patients, none of which were serious. The tolerability of therapy was rated as excellent/good in 81% of patients by physicians and in 78% by the patients. Conclusion: Adapalene gel 0.1% is a safe and effective topical agent in the treatment of mild to moderate acne vulgaris in Indian patients. It may be safely combined with other topical and oral anti-acne agents.

  2. Suspected adverse reactions to contrast media in Campania Region (Italy): results from 14 years of post-marketing surveillance.

    Science.gov (United States)

    Sessa, Maurizio; Rossi, Claudia; Mascolo, Annamaria; Grassi, Enrico; Fiorentino, Sonia; Scavone, Cristina; Reginelli, Alfonso; Rotondo, Antonio; Sportiello, Liberata

    2015-01-01

    During the last years in Italy, contrast media (CM) use increased. An increase of monitoring activities on CM-induced adverse drug reaction (ADR) is necessary, also in our regional territory. The main aim of this study was to give a preliminary evaluation of all Spontaneous Reports of ADRs (SRA) attributed to CM sent to Campania Pharmacovigilance Regional Center (CRFVC) from 01 January 2001 to 31 October 2014. For each SRA we evaluated: frequency and source, ADRs onset (time to event, seriousness and outcome), socio-demographic characteristics and risk factors of cases, the most reported CM (checking for pharmacodynamic and pharmacokinetic interactions). A total of 111 SRA were sent to CRFVC; specialist in radiology was the main source of reports. Ninety-seven SRA (87.3%) were referable to hypersensitivity reactions. Thirty-four SRA (30.6%) reported serious ADRs. The most reported CM were iopamidol, gadobenic acid and gadoteric acid. We identified two SRA induced by pharmacokinetic and/or pharmacodynamic interactions. During 14 years of post-marketing surveillance, only few SRA concerning CM-induced ADRs were sent to CRFVC probably due to underreporting. We aim to improve monitoring activity on CM-induced ADRs especially in hospitals. Most reported ADR and CM were in line with current body of literature.

  3. Volume Shocks around Announcements in the Chinese Stock Market: An Ex-Post Earnings-Information-Based Study of Speculative Behavior

    Directory of Open Access Journals (Sweden)

    Xiangdong Chen

    2017-09-01

    Full Text Available The Second Board Market is typical stock market for high tech companies in China. This paper discusses the relationship between trading volume and price changes in the case of high-tech listed companies in the Chinese Second-Board Stock Market. By using the basic concepts proposed by Kim and Verrecchia, and Kandel and Pearson, and contrasting them with ex-post information from earnings releases, the paper provides findings on the speculative behavior of informed traders with a volume shock premium. The paper suggests that these methods may be further applied to investigating investors’ behavior in speculation, especially for the high-tech-company-based Second-Board Stock Market during announcement periods.

  4. An observational audit of pain scores post-orthopaedic surgery at a ...

    African Journals Online (AJOL)

    2013-08-27

    Aug 27, 2013 ... pumps and indwelling femoral catheters following total knee replacement. ... were < 4 at every time point measurement, and significantly lower than in audit 1 at most assessment times (p .... for discharge from the recovery area to the ward, and then ..... post-operative pain on outcomes following hip fracture.

  5. Minimising post-operative risk using a Post-Anaesthetic Care Tool (PACT): protocol for a prospective observational study and cost-effectiveness analysis.

    Science.gov (United States)

    Street, Maryann; Phillips, Nicole M; Kent, Bridie; Colgan, Stephen; Mohebbi, Mohammadreza

    2015-06-01

    While the risk of adverse events following surgery has been identified, the impact of nursing care on early detection of these events is not well established. A systematic review of the evidence and an expert consensus study in post-anaesthetic care identified essential criteria for nursing assessment of patient readiness for discharge from the post-anaesthetic care unit (PACU). These criteria were included in a new nursing assessment tool, the Post-Anaesthetic Care Tool (PACT), and incorporated into the post-anaesthetic documentation at a large health service. The aim of this study is to test the clinical reliability of the PACT and evaluate whether the use of PACT will (1) enhance the recognition and response to patients at risk of deterioration in PACU; (2) improve documentation for handover from PACU nurse to ward nurse; (3) result in improved patient outcomes and (4) reduce healthcare costs. A prospective, non-randomised, pre-implementation and post-implementation design comparing: (1) patients (n=750) who have surgery prior to the implementation of the PACT and (2) patients (n=750) who have surgery after PACT. The study will examine the use of the tool through the observation of patient care and nursing handover. Patient outcomes and cost-effectiveness will be determined from health service data and medical record audit. Descriptive statistics will be used to describe the sample and compare the two patient groups (pre-intervention and post-intervention). Differences in patient outcomes between the two groups will be compared using the Cochran-Mantel-Haenszel test and regression analyses and reported as ORs with the corresponding 95% CIs. This study will test the clinical reliability and cost-effectiveness of the PACT. It is hypothesised that the PACT will enable nurses to recognise and respond to patients at risk of deterioration, improve handover to ward nurses, improve patient outcomes, and reduce healthcare costs. Published by the BMJ Publishing Group

  6. The applicability of animal health surveillance systems for post-market monitoring of potential adverse effects of genetically modified (GM) feed.

    Science.gov (United States)

    Vince, L; Kleter, G A; Kostov, K; Pfeiffer, D U; Guitian, J

    2018-04-20

    A facultative post market monitoring of potential health impacts of genetically modified (GM) feedstuffs on livestock consuming these feeds after pre-market risk assessment is under ongoing consideration. Within the IPAFEED database, scientific studies on health effects beyond performance in livestock and the results of a systematic search for evidence of outcome effects due to GM feed are consolidated. These outcomes were reviewed and checked for consistency in order to identify plausible syndromes suitable for conducting surveillance. The 24 selected studies showed no consistent changes in any health parameter. There were no repeated studies in any species by GM crop type and animal species. As such, there is insufficient evidence to inform the design of surveillance systems for detecting known adverse effects. Animal health surveillance systems have been proposed for the post market monitoring of potential adverse effects in animals. Such systems were evaluated for their applicability to the detection of hypothetical adverse effects and their strengths and weaknesses to detect syndromes of concern are presented. For known adverse effects, applied controlled post-market studies may yield conclusive and high-quality evidence. For detecting unknown adverse effects, the use of existing surveillance systems may still be of interest. A simulation tool developed within the project can be adapted and applied to existing surveillance systems to explore their applicability to the detection of potential adverse effects of GM feed. Copyright © 2018. Published by Elsevier Ltd.

  7. Multidisciplinary assessment of post-Ebola sequelae in Guinea (Postebogui): an observational cohort study.

    Science.gov (United States)

    Etard, Jean-François; Sow, Mamadou Saliou; Leroy, Sandrine; Touré, Abdoulaye; Taverne, Bernard; Keita, Alpha Kabinet; Msellati, Philippe; Magassouba, N'Fally; Baize, Sylvain; Raoul, Hervé; Izard, Suzanne; Kpamou, Cécé; March, Laura; Savane, Ibrahima; Barry, Moumié; Delaporte, Eric

    2017-05-01

    The high number of survivors from the 2013-16 west African outbreak of Ebola virus disease (EVD) has raised several new issues: long-term clinical complications, psychosocial consequences, risks of EVD reactivation, and secondary transmission due to viral persistence in body fluids. We aimed to assess long-term clinical, psychosocial, and viral outcomes in EVD survivors in Guinea. In this multidisciplinary observational cohort study, we recruited patients aged 1 year or more in four sites in Guinea (Donka National Hospital, Conakry; Macenta Prefectoral Hospital, Macenta; N'zérékoré Regional Hospital, N'zérékoré; and Forécariah Prefectoral Hospital, Forécariah) following discharge from any Ebola treatment centre in Guinea. Eligible patients had had laboratory-confirmed EVD and had then been declared clear of the virus in the blood. All consenting patients were included, with no exclusion criteria. Trained clinicians assessed patients at enrolment to the cohort, recording clinical symptoms and signs of depression. We did routine blood examinations and examined viral persistence in body fluids using RT-PCR. We did psychological evaluations using questionnaires developed for different age groups. Follow-up is planned to 2 years, and here we present findings at enrolment. Between March 23, 2015, and July 11, 2016, we recruited 802 patients, of whom 360 (45%) were male, 442 (55%) were female; 158 (20%) were younger than 18 years. The median age was 28·4 years (range 1·0-79·9, IQR 19·4-39·8). The median delay after discharge was 350 days (IQR 223-491). The most frequent symptoms were general symptoms (324 [40%] patients), musculoskeletal pain (303 [38%]), headache (278 [35%]), depression (124 [17%] of 713 responses), abdominal pain (178 [22%]), and ocular disorders (142 [18%]). More adults than children had at least one clinical symptom (505 [78%] vs 101 [64%], p<0·0003), ocular complications (124 [19%] vs 18 [11%], p=0·0200), or musculoskeletal symptoms

  8. Systematic review of reporting rates of adverse events following immunization: an international comparison of post-marketing surveillance programs with reference to China.

    Science.gov (United States)

    Guo, Biao; Page, Andrew; Wang, Huaqing; Taylor, Richard; McIntyre, Peter

    2013-01-11

    China is the most populous country in the world, with an annual birth cohort of approximately 16 million, requiring an average of 500 million vaccine doses administered annually. In China, over 30 domestic and less than 10 overseas vaccine manufacturers supply over 60 licensed vaccine products, representing a growing vaccine market mainly due to recent additions to the national immunization schedule, but data on post-marketing surveillance for adverse events following immunization (AEFI) are sparse. To compare reporting rates for various categories of AEFI from China with other routine post-marketing surveillance programs internationally. Systematic review of published studies reporting rates of AEFI by vaccine, category of reaction and age from post-marketing surveillance systems in English and Chinese languages. Overall AEFI reporting rates (all vaccines, all ages) in Chinese studies were consistent with those from similar international studies elsewhere, but there was substantial heterogeneity in regional reporting rates in China (range 2.3-37.8/100,000 doses). The highest AEFI reporting rates were for diphtheria-tetanus-pertussis whole-cell (DTwP) and acellular (DTaP) vaccines (range 3.3-181.1/100,000 doses for DTwP; range 3.5-92.6/100,000 doses for DTaP), with higher median rates for DTwP than DTaP, and higher than expected rates for DTaP vaccine. Similar higher rates for DTwP and DTaP containing vaccines, and relatively lower rates for vaccines against hepatitis B virus, poliovirus, and Japanese encephalitis virus were found in China and elsewhere in the world. Overall AEFI reporting rates in China were consistent with similar post-marketing surveillance systems in other countries. Sources of regional heterogeneity in AEFI reporting rates, and their relationships to differing vaccine manufacturers versus differing surveillance practices, require further exploration. Copyright © 2012 Elsevier Ltd. All rights reserved.

  9. [Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

    Science.gov (United States)

    Nakajima, Toshifusa

    2016-04-01

    Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media.

  10. Design Charrette as Methodology for Post-Disaster Participatory Reconstruction: Observations from a Case Study in Fukushima, Japan

    Directory of Open Access Journals (Sweden)

    Hui Zhang

    2015-05-01

    Full Text Available Although there has been a growing body of literature on post-disaster participatory reconstruction, a shared understanding on a participatory approach is insufficient. A design charrette is a participatory planning that is particularly suitable for situations in which multidisciplinary professionals and non-professional stakeholders collaborate to accomplish target tasks in a short period of time. The purpose of this paper is to explore the role of design charrette as a methodology in the context of post-disaster reconstruction in Japan. This will be achieved through a participatory observation on a design charrette in Minamisoma City, Japan, after the Fukushima accident. The charrette includes the participation of multiple stakeholders in intercultural, intergenerational and interdisciplinary exchanges. The contributions and constraints of the charrette are analyzed on the basis of the authors’ observation, and a strategy to improve post-disaster reconstruction charrette is thereby proposed. This study shows that the charrette is a useful method for communication and collaboration in the post-disaster context. Furthermore, it also demonstrates that assuring the participation of all key stakeholders, improving the training of participants and introducing resource analysis during the charrette’s preparatory stage are the essential conditions for the legitimacy and policy compliance of the final result.

  11. Drug-induced lung injury associated with sorafenib: analysis of all-patient post-marketing surveillance in Japan.

    Science.gov (United States)

    Horiuchi-Yamamoto, Yuka; Gemma, Akihiko; Taniguchi, Hiroyuki; Inoue, Yoshikazu; Sakai, Fumikazu; Johkoh, Takeshi; Fujimoto, Kiminori; Kudoh, Shoji

    2013-08-01

    Sorafenib is a multi-kinase inhibitor currently approved in Japan for unresectable and/or metastatic renal cell carcinoma and unresectable hepatocellular carcinoma. Although drug-induced lung injury has recently been the focus of interest in Japanese patients treated with molecular targeting agents, the clinical features of patients receiving sorafenib remain to be completely investigated. All-patient post-marketing surveillance data was obtained within the frame of Special Drug Use Investigation; between April 2008 and March 2011, we summarized the clinical information of 62 cases with drug-induced lung injury among approximately 13,600 sorafenib-treated patients in Japan. In addition, we summarized the results of evaluation by a safety board of Japanese experts in 34 patients in whom pulmonary images were available. For the calculation of reporting frequency, interim results of Special Drug Use Investigation were used. In the sets of completed reports (2,407 in renal cell carcinoma and 647 in hepatocellular carcinoma), the reporting frequency was 0.33 % (8 patients; fatal, 4/8) and 0.62 % (4 patients; fatal, 2/4), respectively. Major clinical symptoms included dyspnea, cough, and fever. Evaluation of the images showed that 18 cases out of 34 patients had a pattern of diffuse alveolar damage. The patients with hepatocellular carcinoma showed a greater incidence and earlier onset of lung injury than those with renal cell carcinoma. Although the overall reporting frequency of sorafenib-induced lung injury is not considered high, the radiological diffuse alveolar damage pattern led to a fatal outcome. Therefore, early recognition of sorafenib-induced lung injury is crucial for physicians and patients.

  12. Clinical significance and epidemiologic analyses of Mycobacterium avium and Mycobacterium intracellulare lung disease from post-marketing surveillance.

    Science.gov (United States)

    Suzuki, Katsuhiro; Kurashima, Atsuyuki; Tatsuno, Kinji; Kadota, Jun-Ichi

    2018-01-01

    In Japan, nontuberculous mycobacterial lung disease is mostly attributable to Mycobacterium avium complex (MAC), i.e., M. avium or M. intracellulare. However, clinical features of the disease caused by these two pathogens have not been studied sufficiently yet. A post-marketing survey of clarithromycin was performed at 130 facilities across Japan. The data on patients with M. avium infection and patients with M. intracellulare infection were selected from this survey for comparison of background variables and clinical features of the two pathogens. Among the patients analyzed (n = 368), 67.4% had M. avium infection and 32.6% had M. intracellulare infection. Stratified analysis revealed no significant differences between the ratio of the two pathogens based on gender, disease type, complication, past medical history, or smoking history. However, the percentage of patients with M. intracellulare infection was significantly higher among those with underlying lung disease than among those without lung disease (p = 0.0217). The percentage of patients with M. intracellulare infection rose significantly with age (p = 0.0296). This age-related change was more significant in women (p = 0.0018). When district-wise analysis was performed for Japan, the percentage of M. intracellulare infection was higher in the Chugoku/Shikoku and Kyushu districts whereas the percentage of M. avium infection was higher in the other districts. This survey revealed some differences in the clinical and epidemiologic features of M. avium and M. intracellulare infection. The significant predominance of M. avium infection among relatively young women is suggestive of an increase in the M. avium/M. intracellulare infection ratio among women in the future. Copyright © 2017 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

  13. Reevaluation of the post-marketing safety of Shuxuening injection based on real-world and evidence-based evaluations.

    Science.gov (United States)

    Wang, Can; Shi, Qing-Ping; Ding, Feng; Jiang, Xiao-Dong; Tang, Wei; Yu, Mei-Ling; Zhu, Jian-Hua

    2018-01-01

    To evaluate the factors influencing suspected hypersensitivity and adverse systemic reactions after Shuxuening injection and to provide innovative ideas and methods for the reevaluation of post-marketing safety of Shuxuening. This study used a prospective, nested case-control study design, combined with a prescription sequence analysis design method. It classified patients who exhibited trigger signals after administration of Shuxuening injection as suspected allergic patients and made comparisons with patients who did not report adverse effects to calculate the correlation between relevant risk factors and suspected allergic reactions. Randomized controlled studies and cohort studies of the adverse drug reaction (ADR) of Shuxuening were performed using a computer database. Data retrieval was carried out by the foundation governing the individual database. Meta-analysis was performed by using R3.2.3 software to evaluate the ADRs of Shuxuening. The results of real-world study showed that administration of Shuxuening in combination with potassium aspartate and magnesium, atorvastatin calcium, Shengmai injection, pantoprazole sodium, or high-dose medication was a risk factor for suspected allergic reactions. Meta-analysis showed that the incidence of adverse events was 5.84% (95% CI 0.0499; 0.0674), and serious adverse reaction rate was 4.36% (95% CI 0.0188; 0.0760) when Shuxuening was used in combination with these drugs. The incidence of allergic reaction was also influenced by the vehicle, duration of treatment, single dose, and indicated vs off-label use. Risk factors for adverse reaction following the use of Shuxuening injection in patients are associated with a single dose, vehicle, type of disease, and combination with potassium aspartate, atorvastatin calcium, Shengmai injection, injection with pantoprazole sodium, and other drugs. Physicians should be careful to follow guidelines when administering this drug. We further propose that the unique methodology

  14. Post-Purchase Evaluation in the Smartphone Market: An Investigation into Cognitive Dissonance among iPhone and Other Smartphone Brand Owners

    OpenAIRE

    Kraappa, Anna

    2011-01-01

    Purpose The main objective was to investigate whether iPhone owners experienced less cognitive post-purchase dissonance than other brand owners and was this due to the marketing communications efforts of Apple Inc., from hereon called Apple. Finally, the influence of Web 2.0 in the process of post-purchase evaluation was examined. Web 2.0 is a version of the Internet and it encourages towards user engagement on websites such as Facebook. Methodology A critical review of the litera...

  15. Observations of a post-flare radio burst in X-rays

    Science.gov (United States)

    Svestka, Z.; Hoyng, P.; Van Tend, W.; Boelee, A.; De Jager, C.; Stewart, R. T.; Acton, L. W.; Bruner, E. C.; Gabriel, A. H.; Rapley, C. G.

    1982-01-01

    More than six hours after the two-ribbon flare of May 21, 1980, the hard X-ray spectrometer aboard the SMM imaged an extensive arch above the flare region which was found to be the lowest part of a stationary post-flare noise storm recorded at the same time at Culgoora. The bent crystal spectrometer aboard the SMM confirms that the arch emission was basically thermal. Variations in brightness and energy spectrum at one of the supposed footpoints of the arch are seen as correlation in time with radio brightness, suggesting that suprathermal particles from the radio noise regions dumped in variable quantities onto the low corona and transition layer.

  16. A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India.

    Science.gov (United States)

    Chandra, Praveen; Kumar, Tarun

    2014-01-01

    A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India. 1. To study the MACE and in stent and In-segment Loss at Six Months (in a pre selected group of 50 patients). 1. Clinical and procedural success. This is a prospective, open label, single-arm, multicenter (16 sites), post marketing observational study enrolling patients implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) in routine clinical practice in India. A total of 200 Patients of coronary Artery Disease (CAD) implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) were enrolled. Clinical assessments were done at 30 days, 180 days and at 1, 2 years either telephonically or office visit. A cohort of 50 pre-selected patients were followed up for angiographic evaluation at 180 days. MACE at 12 month of follow up was 1.71%.Late lumen loss, in segment was 0.14 and in stent was 0.10 mm at 6 month of follow-up. TLR was required only in 2 patients. Superia stent is as safe as other biodegradable polymer stent in the market and time has come for biodegradable polymer stent with thin struts. Copyright © 2014 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  17. The Effects of Post-observational Feedback Modes on Teaching Beliefs : Peer vs. Teacher-Mediated Feedback

    Directory of Open Access Journals (Sweden)

    İlknur Yuksel

    2011-01-01

    Full Text Available The aim of this study was to investigate whether the pre-service teachers' language teaching beliefs changed as a result of two different post-observational reşective feedback modes; teacher mediated and peer feedback, during their teaching practice. For each post-observational feedback mode, two groups of eight Turkish pre-service language teachers attending to the final year at English Language Teaching Department at Anadolu University, totally 16 pre-service teachers participated in the study. The qualitative and quantitative data was collected at the beginning and end of the different feedback treatments from each group. The results indicated that the feedback modes on pre-service teachers’ teaching practice could influence their beliefs about teaching. Peer feedback had a potential to change the teachers’ beliefs through critical reşection skills that were fostered as a result of collaboration within the peer group

  18. [Study on building index system of risk assessment of post-marketing Chinese patent medicine based on AHP-fuzzy neural network].

    Science.gov (United States)

    Li, Yuanyuan; Xie, Yanming; Fu, Yingkun

    2011-10-01

    Currently massive researches have been launched about the safety, efficiency and economy of post-marketing Chinese patent medicine (CPM) proprietary Chinese medicine, but it was lack of a comprehensive interpretation. Establishing the risk evaluation index system and risk assessment model of CPM is the key to solve drug safety problems and protect people's health. The clinical risk factors of CPM exist similarities with the Western medicine, can draw lessons from foreign experience, but also have itself multi-factor multivariate multi-level complex features. Drug safety risk assessment for the uncertainty and complexity, using analytic hierarchy process (AHP) to empower the index weights, AHP-based fuzzy neural network to build post-marketing CPM risk evaluation index system and risk assessment model and constantly improving the application of traditional Chinese medicine characteristic is accord with the road and feasible beneficial exploration.

  19. Variance Analysis of Wind and Natural Gas Generation under Different Market Structures: Some Observations

    Energy Technology Data Exchange (ETDEWEB)

    Bush, B.; Jenkin, T.; Lipowicz, D.; Arent, D. J.; Cooke, R.

    2012-01-01

    Does large scale penetration of renewable generation such as wind and solar power pose economic and operational burdens on the electricity system? A number of studies have pointed to the potential benefits of renewable generation as a hedge against the volatility and potential escalation of fossil fuel prices. Research also suggests that the lack of correlation of renewable energy costs with fossil fuel prices means that adding large amounts of wind or solar generation may also reduce the volatility of system-wide electricity costs. Such variance reduction of system costs may be of significant value to consumers due to risk aversion. The analysis in this report recognizes that the potential value of risk mitigation associated with wind generation and natural gas generation may depend on whether one considers the consumer's perspective or the investor's perspective and whether the market is regulated or deregulated. We analyze the risk and return trade-offs for wind and natural gas generation for deregulated markets based on hourly prices and load over a 10-year period using historical data in the PJM Interconnection (PJM) from 1999 to 2008. Similar analysis is then simulated and evaluated for regulated markets under certain assumptions.

  20. Uterine Fibroid Embolization Can Still Be Improved: Observations on Post-Procedure Magnetic Resonance Imaging

    International Nuclear Information System (INIS)

    Dorenberg, E.J.; Novakovic, Z.; Smith, H.J.; Hafsahl, G.; Jakobsen, J.Aa.

    2005-01-01

    PURPOSE: To evaluate the efficacy and completeness of uterine fibroid embolization (UFE) measured by changes in volume and signal intensity at magnetic resonance imaging (MRI), and to compare with clinical outcome. MATERIAL AND METHODS: 40 women with symptomatic uterine fibroids underwent bilateral uterine artery embolization. At MRI studies, including post-contrast sequences before and repeatedly after treatment, the uterus and dominant fibroids were evaluated for volume, location, and contrast enhancement. Prior to treatment, all myomas showed significant contrast enhancement. The mean uterine volume was 929 ml. Clinical examinations with emphasis on menorrhagia, pelvic pain, and urinary dysfunction were performed before and 6 and 12 months after treatment. RESULTS: UFE was bilaterally successful in 38 patients. After UFE, MRI showed no enhancement of myomas in 30 patients. In 8 patients, post-procedural MRI revealed partially remaining vascularization of fibroids despite angiographically complete embolization of the uterine arteries. On average, uterine volume decreased by 46.2% at 12 months. There was significant improvement of symptoms in the majority of patients, but slightly less improvement in patients with partially remaining vascularization of myomas. CONCLUSION: UFE causes significant volume reduction of myomas and clinical improvement. MRI can reveal remaining vascularization in myomas despite angiographically complete embolization of uterine arteries

  1. Bilateral contracts and the spot market for electricity: some observations on the British and the NordPool experiences

    International Nuclear Information System (INIS)

    Herguera, Inigo

    2000-01-01

    The performance of the futures and the spot market for electricity in England and Wales (EW) and in the Nordic countries have significant differences in terms of volumes traded and evolution of prices. Even though the institutional arrangements show significant differences and the data collected has important limitations we observe in EW for 1990-199 that as the coverage via bilateral contracts diminished, spot prices tended to increase, there was higher price volatility and an increasing number of plants were declared unavailable. In the NordPool, by contrast, market structure is more distributed, the bilateral contract price has tended to smooth the volatility in the spot price and a very diverse pattern behavior of prices has been observed. We interpret these observations as additional support in favor of the theoretical result by and Vila (Journal of Economic Theory 59 (1993) 1), but hint at the possibility of strategies by the firms that can diminish the welfare enhancing properties of this new bilateral market. (Author)

  2. The Internationalization and Market Competition of Tsai Yueh-Hsun’s Post-Confucian TV Drama and Films in East Asia

    OpenAIRE

    Jocelyn Yi-Hsuan Lai

    2018-01-01

    This essay investigates the East Asia-oriented TV and film productions of Taiwanese producer-director Tsai Yueh-hsun. His productions have made wide use of the transnational bankability of Taiwanese TV stars. Set in nationally non-specific urban societies, they are categorized as post-Confucian TV dramas, adopting liberal Western values and presenting problems in the authoritative patriarchal culture of the modern yet Confucian East Asia. They have competed in this market with neo-Confucian K...

  3. Progress on mobility and instability of research personnel in Japan: scientometrics on a job-posting database for monitoring the academic job market

    Energy Technology Data Exchange (ETDEWEB)

    Kawashima, H.; Yamashita, Y.

    2016-07-01

    This study has two purposes. The first purpose is to extract statistics from a database of jobposting cards, previously little-used as a data source, to assess the academic job market. The second purpose is to connect statistics on the academic job market with monitoring of indicators of policy progress related to the mobility and instability of research personnel. The data source used in this study is a job-posting database named JREC-IN Portal, which is the de facto standard for academic job seeking in Japan. The present results show a growing proportion of fixed-term researchers in the Japanese academic job market and that job information is increasingly diverse. (Author)

  4. The Internationalization and Market Competition of Tsai Yueh-Hsun’s Post-Confucian TV Drama and Films in East Asia

    Directory of Open Access Journals (Sweden)

    Jocelyn Yi-Hsuan Lai

    2018-04-01

    Full Text Available This essay investigates the East Asia-oriented TV and film productions of Taiwanese producer-director Tsai Yueh-hsun. His productions have made wide use of the transnational bankability of Taiwanese TV stars. Set in nationally non-specific urban societies, they are categorized as post-Confucian TV dramas, adopting liberal Western values and presenting problems in the authoritative patriarchal culture of the modern yet Confucian East Asia. They have competed in this market with neo-Confucian Korean and mainland Chinese TV dramas that follow Confucian patriarchal values. His productions in the 2000s entered many East Asian markets, including Southeast Asian countries, Japan, and mainland China, with the latter airing censored versions. In the 2010s, his productions have prioritized the rapidly increasing mainland Chinese market among all East Asian markets and adopted Taiwanese-mainland Chinese cooperation. The productions maintain the post-Confucian style of presentation, but remove the political viewpoint commonly perceived in Taiwan. Confronted with Taiwanese skepticism toward the Taiwanese-mainland Chinese cooperation, Tsai argues that this strategy will contribute to the development of Taiwan’s film and TV industry. The presentation of Taiwan’s modern places in the productions will help promote its tourism.

  5. Effectiveness and safety of tolvaptan in liver cirrhosis patients with edema: Interim results of post-marketing surveillance of tolvaptan in liver cirrhosis (START study).

    Science.gov (United States)

    Sakaida, Isao; Terai, Shuji; Kurosaki, Masayuki; Yasuda, Moriyoshi; Okada, Mitsuru; Bando, Kosuke; Fukuta, Yasuhiko

    2017-10-01

    Loop diuretics and spironolactone are used in patients with hepatic edema, but they are sometimes associated with insufficient responses as well as adverse events. Tolvaptan, a vasopressin type 2 receptor antagonist, was approved for hepatic edema in 2013. A large-scale post-marketing surveillance study has been carried out to evaluate the effectiveness and safety of tolvaptan in real-world clinical settings. Patients with hepatic cirrhosis with insufficient response to conventional diuretics were enrolled. The observational period was up to 6 months. Changes in body weight and clinical symptoms were measured to evaluate effectiveness. The incidence of adverse drug reactions was summarized as a safety measure. Of 970 patients enrolled, 463 were included in the safety analysis. Of this group, 340 were included in the effectiveness analysis. Decreases in body weight from baseline were -2.38 kg on day 7 and -3.52 kg on day 14. Ascites and bloated feeling was significantly improved within 14 days. The mean change in body weight depended on estimated glomerular filtration rate levels. The most frequently reported adverse drug reaction was thirst (6.9% of patients). Serum sodium level of ≥146 mEq/L was observed in 12 patients (2.7%). In the real-world clinical setting, tolvaptan showed aquaretic effectiveness in patients with cirrhosis. The mean change in body weight depended on renal function. We recommend tolvaptan use for hepatic cirrhosis at a stage in which the renal function is maintained. © 2016 The Japan Society of Hepatology.

  6. Psychosocial functioning in patients with schizophrenia treated with aripiprazole - an office-based real-world setting. Results from the German post-marketing surveillance study.

    Science.gov (United States)

    Bergmann, F; Zacher, A; Nass, A; Urban, R; Werner, C; Spevakné-Göröcs, T; Kungel, M; Ebrecht, M; Modell, S

    2009-05-01

    Aripiprazole (ABILIFY) is an effective antipsychotic used in a dose range from 10 to 30 mg, administered once daily. Soon after its approval in Germany for treatment of schizophrenia, a 12-month post-marketing surveillance study was initiated that included 1 096 patients cared for by 408 office-based psychiatrists and/or neurologists in private practice. The aim was to gain further insights into safety and efficacy of aripiprazole in an outpatient real-life setting focusing on general health, well-being and psychosocial functioning. Efficacy was rated by using standard CGI, SF-12 and SIWM-PsySo instruments for severity of disease, physical and mental health outcomes and psychosocial state, respectively. Safety was evaluated according to the reports of adverse events. Mean total daily dose of aripiprazole increased from 15.4 mg at the visit after 1 month to 17.6 mg at the visits after 6 to 12 months, the most frequently administered maintenance dose being 15 mg. Within the observation period significant improvements of CGI, SF-12 and SIWM-PsySo scores over time versus baseline values were observed (pmuch" or "very much" improved. Aripiprazole was overall well tolerated; 19.9% of patients discontinued treatment after 12 months. Adverse effects in general were moderate to mild and corresponded to the known tolerability profile of aripiprazole. Psychotic side effects reported were probably due to a recurrence of the underlying schizophrenic disorder. The results indicate that aripiprazole may be an efficacious and safe treatment option for pre-treated patients with schizophrenia also in a naturalistic psychiatrist/neurologist practice setting with effects on health and psychosocial functioning and a comparably low dropout rate.

  7. Radio observations of the fine structure inside a post-CME current sheet

    International Nuclear Information System (INIS)

    Gao Guan-Nan; Wang Min; Lin Jun; Kliem Berhard; Wu Ning; Tan Cheng-Ming; Su Yang

    2014-01-01

    A solar radio burst was observed in a coronal mass ejection/flare event by the Solar Broadband Radio Spectrometer at the Huairou Solar Observing Station on 2004 December 1. The data exhibited various patterns of plasma motions, suggestive of the interaction between sunward moving plasmoids and the flare loop system during the impulsive phase of the event. In addition to the radio data, the associated white-light, Hα, extreme ultraviolet light, and soft and hard X-rays were also studied. (mini-volume: solar radiophysics — recent results on observations and theories)

  8. The Role of Domestic Abuse in Labor and Marriage Markets: Observing the Unobservables

    OpenAIRE

    Audra J. Bowlus; Shannon N. Seitz

    1998-01-01

    In this paper we study the effects of abusive behavior on the labor force and marital status decisions of women. Using a unique Canadian data set on domestic violence, we estimate the effects of abuse on the marital history as well as current employment using a sequential, multi-state model. In our model, spousal abuse affects labor supply through decreases in utility from leisure as well as through reductions in productivity at work and hence the market wage. In addition, abuse is treated as...

  9. POST-OUTBURST RADIO OBSERVATIONS OF THE HIGH MAGNETIC FIELD PULSAR PSR J1119-6127

    Energy Technology Data Exchange (ETDEWEB)

    Majid, Walid A.; Pearlman, Aaron B.; Dobreva, Tatyana; Kocz, Jonathon; Prince, Thomas A. [Jet Propulsion Laboratory, California Institute of Technology, Pasadena, CA 91109 (United States); Horiuchi, Shinji [CSIRO Astronomy and Space Science, Canberra Deep Space Communications Complex, P.O. Box 1035, Tuggeranong, ACT 2901 (Australia); Lippuner, Jonas [TAPIR, Walter Burke Institute for Theoretical Physics, MC 350-17, California Institute of Technology, Pasadena, CA 91125 (United States)

    2017-01-01

    We have carried out high-frequency radio observations of the high magnetic field pulsar PSR J1119-6127 following its recent X-ray outburst. While initial observations showed no evidence of significant radio emission, subsequent observations detected pulsed emission across a large frequency band. In this Letter, we report on the initial disappearance of the pulsed emission and its prompt reactivation and dramatic evolution over several months of observation. The periodic pulse profile at S -band (2.3 GHz) after reactivation exhibits a multi-component emission structure, while the simultaneous X -band (8.4 GHz) profile shows a single emission peak. Single pulses were also detected at S -band near the main emission peaks. We present measurements of the spectral index across a wide frequency bandwidth, which captures the underlying changes in the radio emission profile of the neutron star. The high-frequency radio detection, unusual emission profile, and observed variability suggest similarities with magnetars, which may independently link the high-energy outbursts to magnetar-like behavior.

  10. [Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes].

    Science.gov (United States)

    Ma, Li-xin; Wang, Yu-yi; Li, Xin-xue; Liu, Jian-ping

    2012-03-01

    Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs. Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People's Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011. RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months. Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed. The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report

  11. Post-Newtonian (and higher order) observational constraints on gravitation field theories

    International Nuclear Information System (INIS)

    Nordtvedt, K.

    1982-01-01

    The empirically confirmed premise that gravity is a metric theory is accepted. The general class of all Lagrangian-based metric field theories of gravity is considered. A collection of observational tests of gravitational phenomena which points to a specific metric theory of gravity and rules out alternatives is created

  12. PostGIS-Based Heterogeneous Sensor Database Framework for the Sensor Observation Service

    Directory of Open Access Journals (Sweden)

    Ikechukwu Maduako

    2012-10-01

    Full Text Available Environmental monitoring and management systems in most cases deal with models and spatial analytics that involve the integration of in-situ and remote sensor observations. In-situ sensor observations and those gathered by remote sensors are usually provided by different databases and services in real-time dynamic services such as the Geo-Web Services. Thus, data have to be pulled from different databases and transferred over the network before they are fused and processed on the service middleware. This process is very massive and unnecessary communication and work load on the service. Massive work load in large raster downloads from flat-file raster data sources each time a request is made and huge integration and geo-processing work load on the service middleware which could actually be better leveraged at the database level. In this paper, we propose and present a heterogeneous sensor database framework or model for integration, geo-processing and spatial analysis of remote and in-situ sensor observations at the database level.  And how this can be integrated in the Sensor Observation Service, SOS to reduce communication and massive workload on the Geospatial Web Services and as well make query request from the user end a lot more flexible.

  13. Hospital cost and quality performance in relation to market forces: an examination of U.S. community hospitals in the "post-managed care era".

    Science.gov (United States)

    Jiang, H Joanna; Friedman, Bernard; Jiang, Shenyi

    2013-03-01

    Managed care substantially transformed the U.S. healthcare sector in the last two decades of the twentieth century, injecting price competition among hospitals for the first time in history. However, total HMO enrollment has declined since 2000. This study addresses whether managed care and hospital competition continued to show positive effects on hospital cost and quality performance in the "post-managed care era." Using data for 1,521 urban hospitals drawn from the Healthcare Cost and Utilization Project, we examined hospital cost per stay and mortality rate in relation to HMO penetration and hospital competition between 2001 and 2005, controlling for patient, hospital, and other market characteristics. Regression analyses were employed to examine both cross-sectional and longitudinal variation in hospital performance. We found that in markets with high HMO penetration, increase in hospital competition over time was associated with decrease in mortality but no change in cost. In markets without high HMO penetration, increase in hospital competition was associated with increase in cost but no change in mortality. Overall, hospitals in high HMO penetration markets consistently showed lower average costs, and hospitals in markets with high hospital competition consistently showed lower mortality rates. Hospitals in markets with high HMO penetration also showed lower mortality rates in 2005 with no such difference found in 2001. Our findings suggest that while managed care may have lost its strength in slowing hospital cost growth, differences in average hospital cost associated with different levels of HMO penetration across markets still persist. Furthermore, these health plans appear to put quality of care on a higher priority than before.

  14. Marketing marketing

    NARCIS (Netherlands)

    dr. Karel Jan van Alsem

    2013-01-01

    In deze installatierede betoogt Karel Jan Alsem dat marketing een grotere strategische rol in organisaties zou moeten krijgen. Want marketing is bij uitstek de verbinding tussen klantwensen en het DNA van een organisatie. Doordat merken gemiddeld voor mensen niet heel belangrijk zijn, is goede

  15. Are The ASEAN-5 Foreign Exchange Market Efficient? Evidence From Indonesia, Thailand, Malaysia, Singapore, and Philippines: Post-Global Economic Crisis 2008

    Directory of Open Access Journals (Sweden)

    Aditya Andika Putra

    2016-07-01

    Full Text Available Normal 0 false false false IN X-NONE X-NONE This paper examines market efficiency of foreign exchange markets in South East Asia (Indonesia, Thailand, Malaysia, Singapore, and Philippines after the global crisis period 2008. The time span covered by the samples are from 2009 to 2014, with the total number of observations for spot and forward exchange rate data amounting to 1565 data points. This study uses three different approaches to examine efficiency within countries and across countries. The result of this study shows that foreign exchange markets in the ASEAN-5 countries are efficient within countries, but have not been efficient across countries, especially when the country has a bivariate relationship with Thailand's foreign exchange market. The main implication of this study is that investors in the ASEAN-5 market cannot obtain abnormal returns using technical analysis on within countries foreign exchange market. In addition, there is no significant differences for participants in the foreign exchange market whether they are using hedging or not hedging. Normal 0 false false false IN X-NONE X-NONE

  16. Post-flare coronal arches observed with the SMM/XRP flat crystal spectrometer

    Science.gov (United States)

    Hick, Paul; Svestka, Zdenek; Smith, Kermit L.; Strong, Keith T.

    1987-01-01

    Postflare coronal arch observations made with the SMM Flat Crystal Spectrometer on January 20-23, 1985 are discussed. Results suggest that the arch revival following the dynamic flare of 23:50 UT on January 1 was of the type noted on November 6-8 and June 4, 1980 by the SMM Hard X-ray Imaging Spectrometer (HXIS). Activity different from that of the HXIS observations was found starting at about 23 UT on January 22, with no trigger of the revival being identified, and with the activity being restricted to the coronal regions (without any related disturbance in the chromosphere). The development of the arch enhancement in the corona was shown to be slower than is expected for a flare-associated revival.

  17. LES AMIS D'ESCOFFIER AND THE POST-DEPRESSION LABOR MARKET FOR CHEFS DE CUISINE IN AMERICA

    Directory of Open Access Journals (Sweden)

    Martin T. Ollif

    2001-01-01

    Full Text Available This essay uses a cultural studies approach to analyze the effort of the gourmet society Les Amis d'Escoffier to re-create the niche market for chefs’ services in the waning years of the Great Depression. It examines the depressed labor market for chefs after 1912 as well as aspects of the chefs’ culture that informed the unusual rules and rituals Les Amis used to educate wealthy men in gourmandaise. It concludes that, regardless of how successful the society was in its original goal, culture as well as functional response shaped the chefs’ remedy to their labor market problems.

  18. Safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus: a 1-year post-marketing surveillance in Japan.

    Science.gov (United States)

    Goda, Maki; Yamakura, Tomoko; Sasaki, Kazuyo; Tajima, Takumi; Ueno, Makoto

    2018-02-01

    To evaluate the safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus (T2DM) in clinical settings. The authors conducted a 1-year post-marketing surveillance (PMS) of canagliflozin in almost all the elderly patients (≥65 years old) with T2DM who began taking canagliflozin during the first 3 months after its launch in Japan. The main outcomes included the incidences of adverse drug reactions (ADRs), serious ADRs, and the changes of laboratory tests as well as efficacy variables. An ADR was reported in 9.09% (125 of 1375 patients) in the safety analysis set. The main ADRs were dehydration, constipation, thirst, pollakiuria, dizziness, cystitis, eczema, pruritus, and rash. The incidence of serious ADRs was 1.02% (14 patients), which included urinary tract infection, dehydration, hypoglycemia, and cerebral infarction (two patients each). ADRs of special interest that had been reported in clinical trials of SGLT2 inhibitors, such as hypoglycemia, volume depletion-related events, genital/urinary tract infection, polyuria/pollakiuria, and ketone body increased were also observed in this PMS. The safety profiles were similar to the results of a previous clinical study of canagliflozin, and new safety concerns were not identified in this survey. The mean change in HbA1c was -0.77% after 12 months of treatment in the efficacy analysis set. In this PMS, the safety and efficacy profiles of canagliflozin in elderly patients with T2DM were obtained in the clinical settings in Japan and the drug was well tolerated and effective in improving glycemic control.

  19. The Barrel vascular reconstruction device for endovascular coiling of wide-necked intracranial aneurysms: a multicenter, prospective, post-marketing study.

    Science.gov (United States)

    Gory, Benjamin; Blanc, Raphaël; Turjman, Francis; Berge, Jérôme; Piotin, Michel

    2018-02-02

    The Barrel vascular reconstruction device (Barrel VRD) is a novel stent with design features that allow endovascular coiling of wide-necked bifurcation aneurysms while preserving adjacent branches, without necessitating dual stent implantation. This study aimed to assess the safety and effectiveness of the Barrel VRD at 12-month follow-up. The Barrel VRD trial is a prospective, multicenter, observational post-marketing registry evaluating the use of the Barrel VRD for treatment of wide-necked bifurcation aneurysms. The primary effectiveness endpoint was successful aneurysm treatment measured by digital subtraction angiography with a Raymond-Roy occlusion grade of 1 or 2 in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture at 12 months. The primary safety endpoint was the absence of neurological death or major stroke at 12 months. Twenty patients were enrolled from December 2013 to December 2014. The device was implanted in 19 patients with 19 aneurysms (8 middle cerebral artery, 4 anterior communicating artery, 1 internal carotid artery terminus, 4 basilar artery aneurysms; mean dome height 5.7±1.91 mm; mean neck length 4.8±1.35 mm, mean dome-to-neck ratio 1.6±2.0). Coiling was performed in all cases. The primary effectiveness endpoint was achieved in 78.9% of subjects (15/19; 12 complete occlusions, 3 neck remnants), and the primary safety endpoint was 5.3% (1/19). This prospective study demonstrates that the Barrel VRD device resulted in ~80% occlusion rates and ~5% rates of neurological complications at 1 year after endovascular treatment of wide-necked bifurcation intracranial aneurysms. REGISTERED CLINICAL TRIAL: NCT02125097;Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  20. [Post-marketing surveillance of antibacterial activities of cefozopran against various clinical isolates--II. Gram-negative bacteria].

    Science.gov (United States)

    Igari, Jun; Oguri, Toyoko; Hiramatsu, Nobuyoshi; Akiyama, Kazumitsu; Koyama, Tsuneo

    2003-10-01

    As a post-marketing surveillance, the in vitro antibacterial activities of cefozopran (CZOP), an agent of cephems, against various clinical isolates were yearly evaluated and compared with those of other cephems, oxacephems, carbapenems, monobactams, and penicillins. Changes in CZOP susceptibility among bacteria were also evaluated with the bacterial resistance ratio calculated from the breakpoint MIC. Twenty-five species (4,154 strains) of Gram-negative bacteria were isolated from the clinical materials annually collected from 1996 to 2001, and consisted of Moraxella (Branhamella) catarrhalis, Haemophilus influenzae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae, Enterobacter aerogenes, Serratia marcescens, Serratia liquefaciens, Citrobacter freundii, Citrobacter koseri, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia spp., Pseudomonas aeruginosa, Pseudomonas fluorescens, Pseudomonas putida, Acinetobacter baumannii, Acinetobacter Iwoffii, Burkholderia cepacia, Stenotrophomonas maltophilia, Bacteroides fragilis group, and Prevotella/Porphyromonas. CZOP preserved its antibacterial activity against M. (B.) catarrhalis (MIC90: 4 micrograms/mL) and showed comparable activity to carbapenems against H. influenzae (MIC90: 1 microgram/mL). The antibacterial activity of CZOP against E. coli was preferable (MIC90: 0.125 microgram/mL) and comparable to those of cefpirome (CPR), cefepime (CFPM), and imipenem (IPM). The MIC90 of CZOP against K. pneumoniae and K. oxytoca was 1 and 0.25 microgram/mL, respectively. The MIC90 of CZOP against E. cloacae increased during 6 years (32 to 128 micrograms/mL). The antibacterial activity of CZOP against E. aerogenes was preferable (MIC90: 1 microgram/mL). The antibacterial activities of CZOP against S. marcescens and S. liquefaciens were relatively potent (MIC90: 0.5 and 0.25 microgram/mL) and comparable to those of CPR, CFPM, and carumonam. CZOP preserved comparable antibacterial

  1. Eficácia de limpeza durante o beneficiamento do tomate de mesa Effectiveness of cleaning fresh market tomatoes during post harvest handling

    Directory of Open Access Journals (Sweden)

    Ana Maria de Magalhães

    2009-12-01

    and fruit quality measured by weight loss (%, respiratory activity (CO2 and ethylene evolution. In the first case, the nylon and sisal fiber were more efficient at higher rotations. PET bristles at 40rpm rotation were inefficient, presenting a cleaning index (CI lower than 50%. The nylon brush treatment at 120rpm was the most efficient cleaning process (CI=91%. However, nylon brushes at 160rpm treatment showed the lowest CI (88%. These results were probably associated to the fact that, at higher speeds, fruits tended to jump, causing a poor contact between bristles and fruits. The lowest CI was observed on coconut fiber at 80 and 120rpm treatments. In general, cleaned fruits with nylon and sisal fiber at 120rpm demonstrated higher post-harvest quality alterations when compared to cleaned fruits in these brushes at 160rpm. More bristles flexibility provides better contact fruit/bristles increasing cleaning efficiency, however, it can cause changes on post-harvest fruit quality, but no significant.

  2. One Size (Never) Fits All: Segment Differences Observed Following a School-Based Alcohol Social Marketing Program

    Science.gov (United States)

    Dietrich, Timo; Rundle-Thiele, Sharyn; Leo, Cheryl; Connor, Jason

    2015-01-01

    Background: According to commercial marketing theory, a market orientation leads to improved performance. Drawing on the social marketing principles of segmentation and audience research, the current study seeks to identify segments to examine responses to a school-based alcohol social marketing program. Methods: A sample of 371 year 10 students…

  3. A PROSPECTIVE OBSERVATIONAL STUDY REGARDING PREVALENCE OF DRY EYE DISEASE IN POST-OPERATIVE CATARACT SURGERY PATIENTS OF 140 CASES.

    Directory of Open Access Journals (Sweden)

    S. Srinivasan

    2017-02-01

    Full Text Available BACKGROUND Dry eye disease is one of the most common ocular surface disorder with large number of studies carried out in various countries estimate the prevalence of dry eye disease to be between 5-34%. The prevalence of dry eye increases with age. As per Breaver Dam study regarding dry eye the prevalence of DED 13.3%. Dry eye was apparently higher in women than men. Studies have shown that cataract surgery worsen dry eye symptoms in patients with preexisting dry eye symptoms as well as without preexisting DES, mostly dry eye symptoms last for two months of post cataract surgery period. MATERIALS AND METHODS The prospective observational study was conducted in Department of Ophthalmology, Government Vellore Medical College and Hospital, Vellore. The total number of cataract surgery performed cases were 140 in number. The study period was four months, conducted in tertiary eye center. The Cataract patients were preoperatively at normal tear secretions. Post cataract surgery period from first POD, one week POD, four weeks, six weeks, two months and three months POD examined by slit lamp, Schirmer's test I, TBUT and corneal sensitivity test were performed. RESULTS Our study revealed that increased prevalence in female sex with increased age group range from 51-70 years showed post cataract surgery period dryness of eye. The ratio of Post cataract surgery DED in male and female is 13:29. This shows increased female sex prevalence of postoperative DED. In our study, the prevalence of post cataract surgery dry eye disease was 30%. CONCLUSION 73% cataract surgeries is now clear corneal cataract surgery and this procedure cuts a large part of corneal nerves. The nerve essential for tear production gets disturbed leading to dryness and hence decreased visual function. The corneal nerves are important in self-regulation of tears since they provide the sensation in the feedback loop that signals tear production. When the functions of the nerves get blocked

  4. Observations on Three Endpoint Properties and Their Relationship to Regulatory Outcomes of European Oncology Marketing Applications.

    Science.gov (United States)

    Liberti, Lawrence; Stolk, Pieter; McAuslane, James Neil; Schellens, Jan; Breckenridge, Alasdair M; Leufkens, Hubert

    2015-06-01

    Guidance and exploratory evidence indicate that the type of endpoints and the magnitude of their outcome can define a therapy's clinical activity; however, little empirical evidence relates specific endpoint properties with regulatory outcomes. We explored the relationship of 3 endpoint properties to regulatory outcomes by assessing 50 oncology marketing authorization applications (MAAs; reviewed from 2009 to 2013). Overall, 16 (32%) had a negative outcome. The most commonly used hard endpoints were overall survival (OS) and the duration of response or stable disease. OS was a component of 91% approved and 63% failed MAAs. The most commonly used surrogate endpoints were progression-free survival (PFS), response rate, and health-related quality of life assessments. There was no difference (p = .3801) between the approved and failed MAA cohorts in the proportion of hard endpoints used. A mean of slightly more than four surrogate endpoints were used per approved MAA compared with slightly more than two for failed MAAs. Longer OS and PFS duration outcomes were generally associated with approvals, often when not statistically significant. The approved cohort was associated with a preponderance of statistically significant (p < .05) improvements in primary endpoints (p < .0001 difference between the approved and failed groups). Three key endpoint properties (type of endpoint [hard/surrogate], magnitude of an endpoint outcome, and its statistical significance) are consistent with the European Medicines Agency guidance and, notwithstanding the contribution of unique disease-specific circumstances, are associated with a predictable positive outcome for oncology MAAs. Regulatory decisions made by the European Medicines Agency determine which new medicines will be available to European prescribers and for which therapeutic indications. Regulatory success or failure can be influenced by many factors. This study assessed three key properties of endpoints used in

  5. An explanation for the universal 3.5 power-law observed in currency markets

    Directory of Open Access Journals (Sweden)

    Nicholas A. Johnson

    Full Text Available We present a mathematical theory to explain a recent empirical finding in the Physics literature (Zhao et al., 2013 in which the distributions of waiting-times between discrete events were found to exhibit power-law tails with an apparent universal exponent: α∼3.5. This new theory provides the first ever qualitative and quantitative explanation of Zhao et al.’s surprising finding. It also provides a mechanistic description of the origin of the observed universality, assigning its cause to the emergence of dynamical feedback processes between evolving clusters of like-minded agents. Keywords: Complex systems, Econophysics, Collective, Power law

  6. Observations

    DEFF Research Database (Denmark)

    Rossiter, John R.; Percy, Larry

    2013-01-01

    as requiring a new model of how advertising communicates and persuades, which, as the authors' textbooks explain, is sheer nonsense and contrary to the goal of integrated marketing. We provide in this article a translation of practitioners' jargon into more scientifically acceptable terminology as well...... as a classification of the new advertising formats in terms of traditional analogs with mainstream media advertising....

  7. Spectrophotometry of 25 comets - Post-Halley updates for 17 comets plus new observations for eight additional comets

    Science.gov (United States)

    Newburn, Ray L., Jr.; Spinrad, Hyron

    1989-01-01

    The best possible production figures within the current post-Halley framework and available observations are given for H2O, O(1D), CN, C3, C2 and dust in 25 comets. Of these, the three objects with the smallest mixing ratios of all minor species have moderate to little or no dust and appear 'old'. Comets with large amounts of CN are very dusty, and there is a clear correlation of CN with dust, although comets with little or no dust still have some CN. Thus, CN appears to have at least two sources, dust and one or more parent gases. Also, the C2/CN production ratio changes continuously with heliocentric distance in every comet considered, suggesting that C2 production may be a function of coma density as well as parental abundance. Dust production ranges from essentially zero in Comet Sugano-Saigusa-Fujikawa up to 67,000 kg/s for Halley on March 14, 1986.

  8. [Post-marketing re-evaluation about usage and dosage of Chinese medicine based on human population pharmacokinetics].

    Science.gov (United States)

    Jiang, Junjie; Xie, Yanming

    2011-10-01

    The usage and dosage of Chinese patent medicine are determined by rigorous evaluation which include four clinical trail stages: I, II, III. But the usage and dosage of Chinese patent medicine are lacked re-evaluation after marketing. And this lead to unchanging or fixed of the usage and dosage of Chinese patent medicine instead of different quantity based on different situations in individual patients. The situation of Chinese patent medicine used in clinical application is far away from the idea of the "Treatment based on syndrome differentiation" in traditional Chinese medicine and personalized therapy. Human population pharmacokinetics provides data support to the personalized therapy in clinical application, and achieved the postmarking reevaluating of the usage and dosage of Chinese patent medicine. This paper briefly introduced the present situation, significance and the application of human population pharmacokinetics about re-evaluation of the usage and dosage of Chinese patent medicine after marketing.

  9. Popularity of brand posts on brand fan pages : An investigation of the effects of social media marketing

    NARCIS (Netherlands)

    de Vries, L.; Gensler, S.; Leeflang, P.S.H.

    Social media outlets constitute excellent vehicles for fostering relationships with customers. One specific way to do this is to create brand fan pages on social networking sites. Companies can place brand posts (containing videos, messages, quizzes, information, and other material) on these brand

  10. Price movement in the Brazilian land market (1994-2010: an analysis in the light of post-Keynesian theory

    Directory of Open Access Journals (Sweden)

    TIAGO SANTOS TELLES

    2016-03-01

    Full Text Available ABSTRACT The present study aims to evaluate crop, pasture and forest land prices in Brazil, between 1994 and 2010, in the light of Post-Keynesian theory. The results provide evidence that land, more than just a simple factor of production, must be conceived of as an economic asset. In fact, the price of rural land is determined not only by the expected profitability deriving from agricultural activities but also by the agents' expectations about its future appreciation and liquidity in an economic environment permeated with uncertainty. In this context, as an object of speculation, land has been particularly important as a store of value.

  11. Foundations for the post 2030 space economy: Cislunar and lunar infrastructure, Moon Village, Mars and planetary missions as markets.

    Science.gov (United States)

    Beldavs, Vid; Dunlop, David; Crisafulli, Jim; Bernard, Foing

    2016-04-01

    Introduction: The International Lunar Decade (ILD)[1] is a framework for international collaboration from 2020 to 2030 to achieve the ultimate goal in space -- to open the space frontier. Key to opening a frontier is the capacity to "live off the land" through in situ resource utilization (ISRU). Activities in space will remain limited to exploration until ISRU becomes possible on an industrial scale. ISRU, the mining and use of resources on the Moon, asteroids, comets and other cosmic bodies will enable the opening of the space frontier for permanent occupancy and settlement. The capacity for ISRU creates the basis for a space economy where products and services are traded for resources, and increasingly sophisticated products can be produced from mined resources to help sustain life indefinitely. Enabling ISRU will require infrastructure - energy, transportation, and communications systems, as well as navigation, storage and other support services. However, regolith or other lunar/asteroid material will remain regolith until converted to a form useful to customers that will enable the development of markets. NASA's Mars journey, various planetary missions, and emerging operations on the lunar surface and at EML1 and EML2 will provide initial markets for ISRU. This paper will explore a scenario explaining how a self-sustaining space economy can be achieved by 2030, what kind of infrastructure will need to be developed, the role of NASA's Mars Journey in the creation of markets for ISRU, and the role of private-public partnership for financing the various building blocks of a self-sustaining space economy. Also dis-cussed will be the potential for a Moon Village to serve as a formative structure for the nucleation of elements of an emerging space economy, including its potential role as a forum for actors to play a role in the development of governance mechanisms that eventually would enable commercial and industrial development of the Moon. References: [1] Beldavs

  12. Post-operative recovery profile after laparoscopic cholecystectomy: a prospective, observational study of a multimodal anaesthetic regime

    DEFF Research Database (Denmark)

    Jensen, K; Kehlet, H; Lund, Claus Michael

    2007-01-01

    BACKGROUND: Laparoscopic cholecystectomy is now often an ambulatory procedure, but dependent on short-term post-operative complaints of pain and post-operative nausea and vomiting (PONV). The efficacy of post-anaesthesia care units (PACUs) is therefore important to facilitate return to normal fun...... are predictors of a complicated recovery profile and deserve further attention. Transient oxygen desaturations postpone discharge from the PACU, but the clinical significance of this fact is questionable. Udgivelsesdato: 2007-Apr...

  13. Pre-market approval and post-market direct-to-consumer advertising of medical devices in Australia: a case study of breast cancer screening and diagnostic devices.

    Science.gov (United States)

    Vreugdenburg, T D; Willis, C D; Mundy, L; Hiller, J E

    2013-01-01

    While research investigating direct-to-consumer advertising of therapeutic goods in Australia has historically focused on prescription medicines, recent action taken by regulators against companies promoting medical devices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medical devices due to its potential harms, inadequacies in the current regulatory system have been noted. Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant on industry self-regulation and consumer complaints to draw attention to cases of advertising misconduct. Although some successes in the present system have been observed, we argue that the outlined inadequacies continue to enable the promotion of medical devices to consumers without thorough or sufficient examination of evidence. © 2011 The Authors; Internal Medicine Journal © 2011 Royal Australasian College of Physicians.

  14. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing phase IV study

    Directory of Open Access Journals (Sweden)

    Bashaireh K

    2015-04-01

    Full Text Available Khaldoon Bashaireh,1 Ziad Naser,2 Khaled Al Hawadya,2 Sorour Sorour,2 Rami Nabeel Al-Khateeb3 1Department of Orthopedics Surgery, King Abdullah University Hospital, Jordan University of Science and Technology, Irbid, Jordan; 2Private Clinic, 3Elaf Medical Supplies Company, Amman, Jordan Purpose: The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period.Materials and methods: The study was a post-marketing phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1–4 in the tibio–femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection.Main outcome measure(s: An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated.Main results: The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3

  15. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study.

    Science.gov (United States)

    Bashaireh, Khaldoon; Naser, Ziad; Hawadya, Khaled Al; Sorour, Sorour; Al-Khateeb, Rami Nabeel

    2015-01-01

    The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period. The study was a post-marketing Phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1-4) in the tibio-femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection. An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated. The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3.36, the stiffness score was 0.42, and the physical performance score was 11.5. All side effects were local and transient, and included pain, swelling, and redness of the knee. Most side effects were treated. Hyaluronan should be encouraged as an alternative or adjunct treatment to oral analgesics to reduce their required doses, and delay potential future surgical intervention.

  16. Romanticizing the Market

    DEFF Research Database (Denmark)

    Johnsen, Christian Garmann

    2016-01-01

    is echoed in post-bureaucratic management literature. Comparing Rousseau's romanticization of nature with what I call the romanticization of markets, I show how the post-bureaucratic management literature employs the logic of market rationalism to generate a managerial pedagogy that installs the market...

  17. Post-marketing assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions for paediatric use

    Directory of Open Access Journals (Sweden)

    Plaizier-Vercammen Jacqueline

    2007-01-01

    Full Text Available Abstract Background Artemisinin-derivative formulations are now widely used to treat falciparum malaria. However, the dry powder suspensions developed for children are few and/or are of poor quality. In addition to the active compound, the presence of a suitable preservative in these medicines is essential. In this study, an evaluation of the preservative content and efficacy in some dry suspensions available on the Kenyan market was performed. Method UV spectrophotometry was used to identify the preservatives in each sample while HPLC-UV was used for quantification. After reconstitution of the powders in water, the dissolution of the preservatives was followed for 7 days. Antimicrobial efficacy of the preservatives was assessed by conducting a preservative efficacy test (PET following the European pharmacopoeia standards. Results Four different preservatives were identified namely methylparahydroxybenzoate (MP, propylparahydroxybenzoate (PP, benzoic acid and sorbic acid. MP and PP were identified in Artesiane® (artemether 300 mg/100 ml, Alaxin® (dihydroartemisinin 160 mg/80 ml andGvither ® (artemether 300 mg/100 ml respectively. Sorbic acid was presentin Artenam® (artemether 180 mg/60 ml while benzoic acid was identified in Santecxin® (dihydroartemisinin 160 mg/80 ml andArtexin® (dihydroartemisinin 160 mg/80 ml respectively. Cotecxin® (dihydroartemisinin 160 mg/80 ml did not contain any of the above preservatives. After reconstitution in water, preservativesin 50%(3/6 of the products did not completely dissolve and the PET results revealed that only Artenam® and Gvither® met the requirements for antimicrobial efficacy. The other products did not conform. Conclusion These results show that paediatric antimalarial dry powder formulations on the market may contain ineffective or incorrect amounts of preservatives. This is a potential risk to the patient. Studies conducted on the dry powder suspensions should include the analysis of both

  18. Diffuse large B-cell lymphoma associated with the use of biologic and other investigational agents: the importance of long-term post-marketing safety surveillance.

    Science.gov (United States)

    Goddard, Allison; Borovicka, Judy H; West, Dennis P; Evens, Andrew M; Laumann, Anne

    2011-01-01

    This case report describes a patient who developed diffuse large B-cell lymphoma (DLBCL) after receiving courses of two investigational biologic agents and cyclosporine followed by more than four years of subcutaneous efalizumab for the treatment of extensive chronic plaque psoriasis. Three years later, the patient remains free of lymphoma and his psoriasis is well controlled with thrice-weekly narrow-band ultraviolet phototherapy. This case emphasizes the importance of continued long-term post-marketing safety surveillance and the early reporting of all possible serious side effects, including cancers, related to the use of any newly available product. In particular, surveillance should focus on the immunomodulating biologic agents in order to identify possible dangerous sequelae.

  19. Spectrophotometry of 25 comets - Post-Halley updates for 17 comets plus new observations for eight additional comets

    International Nuclear Information System (INIS)

    Newburn, R.L. Jr.; Spinrad, H.

    1989-01-01

    The best possible production figures within the current post-Halley framework and available observations are given for H2O, O(1D), CN, C3, C2 and dust in 25 comets. Of these, the three objects with the smallest mixing ratios of all minor species have moderate to little or no dust and appear 'old'. Comets with large amounts of CN are very dusty, and there is a clear correlation of CN with dust, although comets with little or no dust still have some CN. Thus, CN appears to have at least two sources, dust and one or more parent gases. Also, the C2/CN production ratio changes continuously with heliocentric distance in every comet considered, suggesting that C2 production may be a function of coma density as well as parental abundance. Dust production ranges from essentially zero in Comet Sugano-Saigusa-Fujikawa up to 67,000 kg/s for Halley on March 14, 1986. 61 references

  20. Risk factors for post-colorectal endoscopic submucosal dissection (ESD) coagulation syndrome: a multicenter, prospective, observational study

    Science.gov (United States)

    Arimoto, Jun; Higurashi, Takuma; Kato, Shingo; Fuyuki, Akiko; Ohkubo, Hidenori; Nonaka, Takashi; Yamaguchi, Yoshikazu; Ashikari, Keiichi; Chiba, Hideyuki; Goto, Shungo; Taguri, Masataka; Sakaguchi, Takashi; Atsukawa, Kazuhiro; Nakajima, Atsushi

    2018-01-01

    Background and study aims  Colorectal cancer (CRC) is one of the most common neoplasms and endoscopic submucosal dissection (ESD) is an effective treatment for early-stage CRC. However, it has been observed that patients undergoing ESD often complain of pain, even if ESD has been successfully performed. Risk factors for such pain still remain unknown. The aim of this study was to explore the risk factors for post-colorectal ESD coagulation syndrome (PECS). Patients and methods  This was a prospective multicenter observational trial (UMIN000016781) conducted in 106 of 223 patients who underwent ESD between March 2015 and April 2016. We investigated age, sex, tumor location, ESD operation time, lesion size, duration of hospitalization, and frequency of PECS. We defined PECS as local abdominal pain (evaluated on a visual analogue scale) in the region corresponding to the site of the ESD that occurred within 4 days of the procedure. Results  PECS occurred in 15/106 (14.2 %), and 10 were women ( P  = 0.01, OR: 7.74 [1.6 – 36.4]), 7 had lesions in the cecum ( P   90 min ( P  = 0.002, OR: 10.3 [2.4 – 44.6]). Frequency of deviation from the prescribed clinical path was significantly higher (47 % [7/15] vs. 2 % [2/91], P  PECS group.  Conclusions  Female gender, location of lesion in the cecum, and ESD operation time > 90 minutes were significant risk factors independent of PECS. These findings are important to management of PECS.  PMID:29527556

  1. Precipitants of Delirium in Older Inpatients Admitted in Surgery for Post-Fall Hip Fracture: An Observational Study.

    Science.gov (United States)

    Levinoff, E; Try, A; Chabot, J; Lee, L; Zukor, D; Beauchet, O

    2018-01-01

    Hip fractures precipitate several acute adverse outcomes in elderly people, thus leading to chronic adverse outcomes. The objective of our study was to examine the clinical characteristics associated with incident delirium in community dwelling elderly individuals who have a hip fracture. Retrospective observational cohort study. Data was collected from an academic tertiary hospital affiliated with McGill University. 114 elderly individuals who were above 65 years of age, who underwent surgery for a fractured hip. The main outcome variable was incident delirium, which was assessed by chart reviews of notes and observations recorded by nurses and physicians when patients were admitted post operatively to the surgical unit. Covariates included age, sex, length of stay, delay to surgery, number of medical comorbidities, number of medications and hip fracture location, and were extracted from medical records. Baseline mobility and functional status, preoperative cognitive impairment, postoperative complications, regular psychotropic medications, psychotropic medications in hospital, and location of discharge were also assessed through chart review. The results demonstrated that 17.5% of participants with a diagnosis of delirium had a longer length of hospitalization (p = 0.01), a lower baseline functional status (p = 0.03) and pre-operative cognitive impairment (p = 0.01). Patients receiving new psychotropic medications in hospital were more likely to have delirium (OR = 4.6, p = 0.01) which was independent of pre-operative cognitive impairment. We have shown that an association exists between psychotropic medication prescription and incident delirium in patients with hip fractures, even when adjusting for cognitive impairment. Hence, the prescription of psychotropic drugs should be judicious in these patients so as minimize the risk of adverse outcomes.

  2. Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction

    Science.gov (United States)

    Nawroth, Frank; Tandler-Schneider, Andreas; Bilger, Wilma

    2015-01-01

    This prospective, noninterventional, post-marketing surveillance study evaluated doses of recombinant human follicle-stimulating hormone (r-hFSH) using the redesigned follitropin alfa pen in women who were anovulatory or oligomenorrheic and undergoing ovulation induction (OI) alone or OI with intrauterine insemination. The primary endpoint was the proportion of patients who achieved monofollicular or bifollicular development (defined as one or two follicles ≥15 mm). Secondary endpoints included characteristics of ovulation stimulation treatment, such as mean total and mean daily r-hFSH doses. Data were analyzed for 3,193 patients from 30 German fertility centers. The proportion of patients with monofollicular or bifollicular development was 71.1% (n=2,270 of a total of 3,193 patients; intent-to-treat population). The mean±standard deviation total and daily doses of r-hFSH were 696.9±542.5 IU and 61.7±29.4 IU, respectively. The three doses prescribed most frequently were: 37.5 IU (n=703 from N=3,189; 22.0%), 50.0 IU (n=1,056 from N=3,189; 33.1%), and 75.0 IU (n=738 from N=3,189; 23.1%) on the first day of stimulation; and 37.5 IU (n=465 from N=3,189; 14.6%), 50.0 IU (n=922 from N=3,189; 28.9%), and 75.0 IU (n=895 from N=3,189; 28.1%) on the last day of stimulation. This noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of patients studied and the small dose increment (12.5 IU) of the redesigned follitropin alfa pen allowed individualized treatment of women undergoing OI. PMID:25926755

  3. Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 12-Month Results.

    Science.gov (United States)

    Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Snyder, Scott A; Dake, Michael D

    2016-02-08

    This multicenter, prospective, post-market surveillance study in Japan evaluates the paclitaxel-coated Zilver PTX stent in real-world patients with complex lesions. The Zilver PTX stent is the first drug-eluting stent (DES) approved for the superficial femoral artery. Previously, results from a large randomized study and a complementary, large single-arm study supported the safety and effectiveness of the DES. There were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease (PAD) treated with the DES were enrolled in the study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms of PAD. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. In this study, 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including high incidences of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were also complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 DES were placed in 1,075 lesions. Twelve-month follow-up was obtained for >95% of eligible patients. Freedom from TLR was 91.0%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%. Despite more challenging lesions, results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX DES in a real-world patient population. (Zilver PTX Post-Market Study in Japan; NCT02254837). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  4. Safety and effectiveness of 24-week treatment with iguratimod, a new oral disease-modifying antirheumatic drug, for patients with rheumatoid arthritis: interim analysis of a post-marketing surveillance study of 2679 patients in Japan.

    Science.gov (United States)

    Mimori, Tsuneyo; Harigai, Masayoshi; Atsumi, Tatsuya; Fujii, Takao; Kuwana, Masataka; Matsuno, Hiroaki; Momohara, Shigeki; Takei, Syuji; Tamura, Naoto; Takasaki, Yoshinari; Ikeuchi, Satoshi; Kushimoto, Satoru; Koike, Takao

    2017-09-01

    To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, post-marketing surveillance study was conducted. An interim analysis at week 24 was performed. This study included all RA patients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24. Safety was analyzed in 2679 patients. The overall incidences of AEs, ADRs, and serious ADRs were 38.41, 31.65, and 3.21%, respectively; the most commonly reported serious ADRs were pneumonia/bacterial pneumonia, interstitial lung disease, and Pneumocystis jiroveci pneumonia. Concomitant glucocorticoid use and comorbid conditions associated with respiratory disease were identified as risk factors for serious infections. Pulmonary alveolar hemorrhage and increased international normalized ratio of prothrombin time were observed with concomitant use of IGU and warfarin. The DAS28-CRP decreased from baseline to week 24. Although a safety concern was identified with concomitant use of IGU and warfarin, this real-world study showed no other new safety concerns and similar effectiveness to clinical trials. IGU is a new therapeutic option for RA patients.

  5. Association between oxidative stress index and post-CPR early mortality in cardiac arrest patients: A prospective observational study.

    Science.gov (United States)

    Yücel, Hasan; Türkdoğan, Kenan Ahmet; Zorlu, Ali; Aydın, Hüseyin; Kurt, Recep; Yılmaz, Mehmet Birhan

    2015-09-01

    Cardiopulmonary resuscitation (CPR) is a series of lifesaving actions that improve the chance of survival following cardiac arrest (CA). Many clinical and laboratory parameters, such as the presence of asystole, out-of-hospital CPR, and duration of cardiac arrest, are associated with failed CPR in patients with CA. Asystole is a state of no cardiac electrical activity, along with the absence of contractions of the myocardium and absence of cardiac output. Oxidative stress index (OSI), which is the ratio of total oxidative status to total antioxidant status, increases by ischemia-reperfusion injury. We investigated whether OSI levels in patients with CA could predict early mortality after CPR. This study has a prospective observational cohort design. Five patients with a history of cancer, four patients who developed hemolysis in their blood, six patients who were transferred to our hospital from other hospitals, and six patients in whom blood samples for OSI could not be stored properly were excluded. Finally, a total of 90 in-hospital or out-of-hospital CA patients and 40 age- and sex-matched healthy volunteers as the control group were evaluated prospectively. The patients were classified according to the CPR response into a successful group (n=46) and a failed group (n=44). Comparisons between groups were performed using one-way ANOVA with post hoc analysis by Tukey's HSD or independent samples t-test and the Kruskal-Wallis tests or Mann- Whitney U test for normally and abnormally distributed data, respectively. Also, we used chi-square test, Spearman's correlation test, univariate and multible logistic regression analyses, and receiver operator characteristic curve analysis. OSI was 3.0±4.0, 5.6±4.3, and 8.7±3.8 in the control group, the successful CPR group, and the failed CPR group, respectively (pOSI on admission, ischemia-modified albumin, presence of asystole, mean duration of cardiac arrest, out-of-hospital CPR, pH, and potassium and sodium levels were

  6. Efficacy of early intervention of motor relearning program on post-stroke hemiplemia:A randomized controlled observation

    Institute of Scientific and Technical Information of China (English)

    Jia Xue; Liang Bai; Qingrong Guo; Chengrong Yang; Jie Lu

    2006-01-01

    BACKGROUND: Previous studies believed that the effect of rehabilitation training within 6 months after stroke (early rehabilitation training) is usually unsatisfactory. The rehabilitation training when acute stroke is stabilized may be better for the recovery of limb function.OBJECTIVE: To observe the effects of the rehabilitation training of motor relearning program plus Bobath technique on the motor function of limbs, nerve function and activities of daily life (ADL) in patients with acute stroke hemiplegia.DESIGN: A randomized controlled observation.SETTING: Department of Neurology, Yaan People's Hospital.PARTICrPANTS: A total of 150 patients with acute post-stroke hemiplegia were selected from the Department of Neurology, Yaan People's Hospital from March 2000 to October 2002. The patients were all accorded with the diagnostic standards about stroke set by the Fifth National Academic Meeting for Cerebrovascular Disease (1996), confirmed by CT and MRI, and they were all informed with the interventions and the items of evaluation. The enrolled patients were randomly divided into training group (n=78) and control group (n=72) at admission. METHODS: ① Interventions: All the patients were given routine treatments for stroke, including managin blood pressure, maintaining the balance of hydrolyte and electrolure, reducing intracranial pressure by dehydration,and venous injection of citicoline, besides those in the training group received rehabilitation training by motor relearning program and Bobath technique. The rehabilitation training began after the vital signs became stable within 24 hours to 3 days after attack for the patients with cerebral infarction and 48 hours to 5 days after attack for those with cerebral hemorrhage respectively, three times a day in the morning, at noon and in the evening respectively, 30 minutes for each time, they were trained for 1 month. Lying position: The patients should keep the anti-spasm posture in the supine position

  7. Substantial Underestimation of Post-harvest Burning Emissions in East China as Seen by Multi-species Space Observations

    Science.gov (United States)

    Stavrakou, T.; Muller, J. F.; Bauwens, M.; De Smedt, I.; Lerot, C.; Van Roozendael, M.

    2015-12-01

    Crop residue burning is an important contributor to global biomass burning. In the North China Plain, one of the largest and densely populated world plains, post-harvest crop burning is a common agricultural management practice, allowing for land clearing from residual straw and preparation for the subsequent crop cultivation. The most extensive crop fires occur in the North China Plain in June after the winter wheat comes to maturity, and have been blamed for spikes in air pollution leading to serious health problems. Estimating harvest season burning emissions is therefore of primary importance to assess air quality and define best policies for its improvement in this sensitive region. Bottom-up approaches, either based on crop production and emission factors, or on satellite burned area and fire radiative power products, have been adopted so far, however, these methods crucially depend, among other assumptions, on the satellite skill to detect small fires, and could lead to underestimation of the actual emissions. The flux inversion of atmospheric observations is an alternative, independent approach for inferring the emissions from crop fires. Satellite column observations of formaldehyde (HCHO) exhibit a strong peak over the North China Plain in June, resulting from enhanced pyrogenic emissions of a large suite of volatile organic compounds (VOCs), precursors of HCHO. We use vertical columns of formaldehyde retrieved from the OMI instrument between 2005 and 2012 as constraints in an adjoint inversion scheme built on IMAGESv2 CTM, and perform the optimization of biogenic, pyrogenic, and anthropogenic emission parameters at the model resolution. We investigate the interannual variability of the top-down source, quantify its importance for the atmospheric composition on the regional scale, and explore its uncertainties. The OMI-based crop burning source is compared with the corresponding anthropogenic flux in the North China Plain, and is evaluated against HCHO

  8. Interchangeability of biosimilar and biological reference product: updated regulatory positions and pre- and post-marketing evidence.

    Science.gov (United States)

    Trifirò, Gianluca; Marcianò, Ilaria; Ingrasciotta, Ylenia

    2018-03-01

    Since 2006, biosimilars have been available in several countries worldwide, thus allowing for potential savings in pharmaceutical expenditure. However, there have been numerous debates about the interchangeability of biosimilars and reference products based on concerns of immunogenicity by switching between biological products, which may cause lack of effect and toxicity. Areas covered: The authors provide the reader with an overview of the different positions of regulatory authorities on the interchangeability and automatic substitution of biosimilars and reference products. Presently, the FDA allows automatic substitution without prescriber intervention if the biosimilar is interchangeable with reference products, while the European Medicines Agency delegate to each single EU member state. Expert opinion: Different approaches in defining interchangeability and automatic substitution call for harmonization to increase confidence of healthcare professionals and patients about the clinical impact of switching. Networks of electronic healthcare records and administrative databases, potentially linkable to clinical charts and registries may rapidly assess frequency and benefit-risk profile of different switching patterns in routine care at different levels, thus integrating and strengthening pre-marketing evidence.

  9. ["Re-evaluation upon suspected event" is an approach for post-marketing clinical study: lessons from adverse drug events related to Bupleuri Radix preparations].

    Science.gov (United States)

    Wu, Shu-Xin; Sun, Hong-Feng; Yang, Xiao-Hui; Long, Hong-Zhu; Ye, Zu-Guang; Ji, Shao-Liang; Zhang, Li

    2014-08-01

    We revisited the "Xiao Chaihu Decoction event (XCHDE)" occurred in late 1980s in Japan and the Bupleuri Radix related adverse drug reaction (ADR) reports in China After careful review, comparison, analysis and evaluation, we think the interstitial pneumonitis, drug induced Liver injury (DILI) and other severe adverse drug envents (ADEs) including death happened in Japan is probably results from multiple factors, including combinatory use of XCHDE with interferon, Kampo usage under modern medicine theory guidance, and use of XCHD on the basis of disease diagnosis instead of traditional Chinese syndrome complex differentiation. There are less ADE case reports related to XCHD preparation in China compared to Japan, mostly manifest with hypersensitivity responses of skin and perfuse perspiration. The symptoms of Radix Bupleuri injection related ADEs mainly manifest hypersensitivity-like response, 2 cases of intravenous infusion instead of intramuscular injection developed hypokalemia and renal failure. One case died from severe hypersensitivity shock. In Chinese literatures, there is no report of the interstitial pneumonitis and DILI associated with XCHDG in Japan. So far, there is no voluntary monitoring data and large sample clinical research data available. The author elaborated the classification of "reevaluation" and clarified "re-evaluation upon events" included the reaction to the suspected safety and efficacy events. Based on the current status of the clinical research on the Radix Bupleuri preparations, the author points out that post-marketing "re-evaluation upon suspected event" is not only a necessity of continuous evaluation of the safety, efficacy of drugs, it is also a necessity for providing objective clinical research data to share with the international and domestic drug administrations in the risk-benefit evaluation. It is also the unavoidable pathway to culture and push the excellent species and famous brands of TCM to the international market, in

  10. A multicenter post-marketing evaluation of the Elixir DESolve® Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study.

    Science.gov (United States)

    Nef, Holger; Wiebe, Jens; Boeder, Niklas; Dörr, Oliver; Bauer, Timm; Hauptmann, Karl-Eugen; Latib, Azeem; Colombo, Antonio; Fischer, Dieter; Rudolph, Tanja; Foin, Nicolas; Richardt, Gert; Hamm, Christian

    2018-03-06

    To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease. The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor. One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined. The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths. Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed. © 2018 Wiley Periodicals, Inc.

  11. Enhancing Pre- and Post-Wildfire Vegetation Recovery and Understanding Feedbacks of Cheatgrass invasion Using NASA Earth Observations

    Science.gov (United States)

    Olsen, N.; Counts, A.; Quistorff, C.; Ohr, C. A.; Toner, C.

    2017-12-01

    Increasing wildfire frequency and severity has emphasized the importance of post-wildfire recovery efforts in southern Idaho's sagebrush ecosystems. These changing fire regimes favor invasive grass species while hindering native sagebrush habitat regeneration, causing a positive feedback cycle of invasive growth - wildfires - invasive growth. Due to this undesirable process and anthropogenic influences, the sagebrush ecosystem is one of the most endangered in the US. In this project the NASA DEVELOP group of Pocatello, Idaho partnered with the Bureau of Land Management, Idaho Department of Fish and Game, and the US Department of Agriculture to characterize ecosystem recovery following the Crystal (2006), Henry Creek (2016), Jefferson (2010), and Soda (2015) wildfires. Determining vegetation cover heterogeneity and density can be time consuming and the factors affecting ecosystem recovery can be complex. In addition, restoration success is difficult to determine as vegetation composition is not often known prior to wildfire events and monitoring vegetation composition after restoration efforts can be resource intensive. These wildfires temporal monitoring consisted of 2001 to 2017 using NASA Earth observations such as Landsat 5 Thermal Mapper (TM), Landsat 8 Operational Land Imager (OLI), Terra Moderate Resolution Imaging Spectroradiometer (MODIS), and Shuttle Radar Topography Mission (SRTM) to determine the most significant factors of wildfire recovery and the influence targeted grazing could have for recovery. In addition, this project will include monitoring of invasive species propagation and whether spatial patterns or extents of the wildfire contribute to propagation. Understanding the key variables that made reseeding and natural recovery work in some areas, assessing why they failed in others, and identifying factors that made non-native propagation ideal are important issues for land managers in this region.

  12. Safety and effectiveness of tacrolimus add-on therapy for rheumatoid arthritis patients without an adequate response to biological disease-modifying anti-rheumatic drugs (DMARDs): Post-marketing surveillance in Japan.

    Science.gov (United States)

    Takeuchi, Tsutomu; Ishida, Kota; Shiraki, Katsuhisa; Yoshiyasu, Takashi

    2018-01-01

    Post-marketing surveillance (PMS) was conducted to assess the safety and effectiveness of tacrolimus (TAC) add-on therapy for patients with rheumatoid arthritis (RA) and an inadequate response to biological disease-modifying anti-rheumatic drugs (DMARDs). Patients with RA from 180 medical sites across Japan were registered centrally with an electronic investigation system. The observational period was 24 weeks from the first day of TAC administration concomitantly with biological DMARDs. Safety and effectiveness populations included 624 and 566 patients, respectively. Patients were predominantly female (81.1%), with a mean age of 61.9 years. Overall, 125 adverse drug reactions (ADRs) occurred in 94 patients (15.1%), and 15 serious ADRs occurred in 11 patients (1.8%). These incidences were lower compared with previously reported incidences after TAC treatment in PMS, and all of the observed ADRs were already known. A statistically significant improvement was observed in the primary effectiveness variable of Simplified Disease Activity Index after TAC treatment; 62.7% of patients achieved remission or low disease activity at week 24. TAC is well tolerated and effective when used as an add-on to biological DMARDs in Japanese patients with RA who do not achieve an adequate response to biological DMARDs in a real-world clinical setting.

  13. The origin and reduction of spurious extrahepatic counts observed in 90Y non-TOF PET imaging post radioembolization

    Science.gov (United States)

    Walrand, Stephan; Hesse, Michel; Jamar, François; Lhommel, Renaud

    2018-04-01

    Our literature survey revealed a physical effect unknown to the nuclear medicine community, i.e. internal bremsstrahlung emission, and also the existence of long energy resolution tails in crystal scintillation. None of these effects has ever been modelled in PET Monte Carlo (MC) simulations. This study investigates whether these two effects could be at the origin of two unexplained observations in 90Y imaging by PET: the increasing tails in the radial profile of true coincidences, and the presence of spurious extrahepatic counts post radioembolization in non-TOF PET and their absence in TOF PET. These spurious extrahepatic counts hamper the microsphere delivery check in liver radioembolization. An acquisition of a 32P vial was performed on a GSO PET system. This is the ideal setup to study the impact of bremsstrahlung x-rays on the true coincidence rate when no positron emission and no crystal radioactivity are present. A MC simulation of the acquisition was performed using Gate-Geant4. MC simulations of non-TOF PET and TOF-PET imaging of a synthetic 90Y human liver radioembolization phantom were also performed. Internal bremsstrahlung and long energy resolution tails inclusion in MC simulations quantitatively predict the increasing tails in the radial profile. In addition, internal bremsstrahlung explains the discrepancy previously observed in bremsstrahlung SPECT between the measure of the 90Y bremsstrahlung spectrum and its simulation with Gate-Geant4. However the spurious extrahepatic counts in non-TOF PET mainly result from the failure of conventional random correction methods in such low count rate studies and poor robustness versus emission-transmission inconsistency. A novel proposed random correction method succeeds in cleaning the spurious extrahepatic counts in non-TOF PET. Two physical effects not considered up to now in nuclear medicine were identified to be at the origin of the unusual 90Y true coincidences radial profile. TOF reconstruction removing

  14. Effects of Speech Therapy in Hospitalized Patients with Post-Stroke Dysphagia: A Systematic Review of Observational Studies

    Directory of Open Access Journals (Sweden)

    Joice Santos Andrade

    2017-12-01

    Conclusion: Speech therapy in hospital bed in post-stroke hospitalized patients with dysphagia seems to bring satisfactory results in the short-term, revealing the importance of diagnosis and early intervention in these cases.

  15. [Post-marketing re-evaluation of Kudiezi injection study on early treatment in patients with ischemic stroke].

    Science.gov (United States)

    Ye, Xiaoqin; Wei, Xu; Xie, Yanming; Zou, Yihuai; Zhao, Xingquan; Han, Jianhua; Wang, Xinzhi; Ma, Yunzhi; Bi, Qi; Xie, Qingfan; Zhao, Jianjun; Cao, Xiaolan; Chen, Hongxia; Wang, Shizhong; Yan, Rongmei; Han, Zucheng; Yi, Danhui; Wang, Yongyan

    2011-10-01

    To study the effect and safety of Kudiezi injection on patients with acute ischemic stroke. Seven hundreds patients were divided into two groups by central randomization system. The study group, 346 cases, was treated with kudiezi injection plus traditional Chinese medicine (TCM) synthesis rehabilitation project, and the control group, 354 cases, was treated with synthetic rehabilitation project. The patients were treated for 10 to 21 days. Before treatment and at the 7th, 14th and 21th day of treatment, the indexes include NIHSS used for evaluating the neurological deficit degree and the motor function score (Fugl-Meyer) for evaluating motor function were observed. The safety index is defined by adverse observation event and laboratory test. The incidence of adverse events and laboratory tests results were observed before and after treatment at the same time. Application of generalized estimating equation model, we found that as the treatment time, NIHSS score and FMI score of the two groups showed a trend of improvement. And at the 14th days and 21th days of treatment, compared to the control group the treatment group showed significant statistical difference on the impact of NIHSS and FMI (Pinjection plus TCM rehabilitation project of ischemic stroke showed some superiority to western medicine rehabilitation program on improving the neurological deficit and motor function. Kudiezi injection is safe and effective in the treatment of acute ischemic stroke.

  16. Compliance with the International Code of Marketing of breast-milk substitutes: an observational study of pediatricians' waiting rooms.

    Science.gov (United States)

    Dodgson, Joan E; Watkins, Amanda L; Bond, Angela B; Kintaro-Tagaloa, Cheryl; Arellano, Alondra; Allred, Patrick A

    2014-04-01

    Abstract The importance of breastmilk as a primary preventative intervention is widely known and understood by most healthcare providers. The actions or non-actions that heathcare providers take toward promoting and supporting breastfeeding families make a difference in the success and duration of breastfeeding. Recognizing this relationship, the World Health Organization developed the International Code of Marketing of Breast-milk Substitutes (the Code), which defines best practices in breastfeeding promotion, including physicians' offices. The pediatric practices' waiting rooms are often a family's first experience with pediatric care. The specific aims of this study were to describe (1) Code compliance, (2) the demographic factors affecting the Code compliance, and (3) the amount and type of breastfeeding-supportive materials available in the pediatricians' waiting rooms. An observational cross-sectional design was used to collect data from 163 (82%) of the pediatric practices in Maricopa County, Arizona. None of the 100 waiting rooms that had any materials displayed (61%) was found to be completely Code compliant, with 81 of the offices having formula-promotional materials readily available. Waiting rooms in higher income areas offered more non-Code-compliant materials and gifts. Breastfeeding support information and materials were lacking in all but 18 (18%) offices. A positive relationship (t97=-2.31, p=0.02) occurred between the presence of breastfeeding educational materials and higher income areas. We were able to uncover some practice-related patterns that impact families and potentially undermine breastfeeding success. To move current practices toward breastfeeding-friendly physicians' offices, change is needed.

  17. Tocilizumab use in pregnancy: Analysis of a global safety database including data from clinical trials and post-marketing data.

    Science.gov (United States)

    Hoeltzenbein, Maria; Beck, Evelin; Rajwanshi, Richa; Gøtestam Skorpen, Carina; Berber, Erhan; Schaefer, Christof; Østensen, Monika

    2016-10-01

    Analyze the cumulative evidence for pregnancy outcomes after maternal exposure to tocilizumab, an anti-interleukin-6-receptor monoclonal antibody used for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis. At present, published experience on tocilizumab use during pregnancy is very limited. We have analyzed all pregnancy-related reports documented in the Roche Global Safety Database until December 31, 2014 (n = 501). After exclusion of ongoing pregnancies, duplicates, and cases retrieved from the literature, 399 women were found to have been exposed to tocilizumab shortly before or during pregnancy, with pregnancy outcomes being reported in 288 pregnancies (72.2%). Of these 288 pregnancies, 180 were prospectively reported resulting in 109 live births (60.6%), 39 spontaneous abortions (21.7%), 31 elective terminations of pregnancy (17.2%), and 1 stillbirth. The rate of malformations was 4.5%. Co-medications included methotrexate in 21.1% of the prospectively ascertained cases. Compared to the general population, an increased rate of preterm birth (31.2%) was observed. Retrospectively reported pregnancies (n = 108) resulted in 55 live births (50.9%), 31 spontaneous abortions (28.7%), and 22 elective terminations (20.4%). Three infants/fetuses with congenital anomalies were reported in this group. No increased risks for adverse pregnancy outcomes were observed after paternal exposure in 13 pregnancies with known outcome. No indication for a substantially increased malformation risk was observed. Considering the limitations of global safety databases, the data do not yet prove safety, but provide information for physicians and patients to make informed decisions. This is particularly important after inadvertent exposure to tocilizumab, shortly before or during early pregnancy. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Optimal implantation depth and adherence to guidelines on permanent pacing to improve the results of transcatheter aortic valve replacement with the medtronic corevalve system: The CoreValve prospective, international, post-market ADVANCE-II study

    NARCIS (Netherlands)

    A.S. Petronio (Anna); J.-M. Sinning (Jan-Malte); N.M. van Mieghem (Nicolas); G. Zucchelli (Giulio); G. Nickenig (Georg); R. Bekeredjian (Raffi); J. Bosmans (Johan); F. Bedogni (Francesco); M. Branny (Marian); K. Stangl (Karl); J. Kovac (Jan); M. Schiltgen (Molly); S. Kraus (Stacia); P.P.T. de Jaegere (Peter)

    2015-01-01

    textabstractObjectives The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis,

  19. Methodological approaches to developing and establishing the body of evidence on post-marketing Chinese medicine safety.

    Science.gov (United States)

    Liao, Xing; Robinson, Nicola

    2013-07-01

    Evidence based medicine demands the highest form of scientific evidence to demonstrate the efficacy and clinical effectiveness for any therapeutic intervention in order to provide best care. It is however accepted that in the absence of scientific evidence, personal experience and expert opinion together with professional judgement are critical. Obtaining evidence for drug safety, postmarketing surveillance (PMS) has focussed on follow up of observational cohorts exposed to a particular drug in order to estimate the incidence of adverse drug reactions (ADRs). Evidence on PMS of Chinese herbal products is still limited, in particular for herbal injections. The aim of this article is to suggest a new model of ascertaining the safety of Chinese medicine using a more comprehensive approach for collecting data. To collect safety data on the Chinese herbal injection, Kudiezi, a mixed methods approach is proposed using 18 hospital information systems to detect ADRs in order to prospectively observe 30,000 patients over 3 years. Evidence will also be collected using a questionnaire survey and through a sample of semi structured interviews. This information based on the expert opinion and the experience of clinicians will produce additional data on the frequency and types of side effects in clinical practice. Furthermore semi structured interviews with a random sample of patients receiving the injection will be carried out to ascertain any potential side effects missed. It is hoped that this comprehensive approach to data collection will accumulate wider evidence based on individual traditional Chinese medicine care and treatment and provide important feedback to the national data collection system to ensure completeness of ADR data recording, monitoring and any potential wider effects through developing improved ADR guidelines.

  20. Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction

    Directory of Open Access Journals (Sweden)

    Nawroth F

    2015-04-01

    Full Text Available Frank Nawroth,1 Andreas Tandler-Schneider,2 Wilma Bilger3 1Centre for Reproductive and Prenatal Medicine, Endocrinology and Osteology, Hamburg, Germany; 2Center for Reproductive Medicine, Fertility Center Berlin, Berlin, Germany; 3Medical Affairs, Fertility, Endocrinology and General Medicine, Merck Serono GmbH, Darmstadt, Germany (an affiliate of Merck KGaA, Darmstadt, Germany Abstract: This prospective, noninterventional, post-marketing surveillance study evaluated doses of recombinant human follicle-stimulating hormone (r-hFSH using the redesigned follitropin alfa pen in women who were anovulatory or oligomenorrheic and undergoing ovulation induction (OI alone or OI with intrauterine insemination. The primary endpoint was the proportion of patients who achieved monofollicular or bifollicular development (defined as one or two follicles 15 mm. Secondary endpoints included characteristics of ovulation stimulation treatment, such as mean total and mean daily r-hFSH doses. Data were analyzed for 3,193 patients from 30 German fertility centers. The proportion of patients with monofollicular or bifollicular development was 71.1% (n=2,270 of a total of 3,193 patients; intent-to-treat population. The mean±standard deviation total and daily doses of r-hFSH were 696.9±542.5 IU and 61.7±29.4 IU, respectively. The three doses prescribed most frequently were: 37.5 IU (n=703 from N=3,189; 22.0%, 50.0 IU (n=1,056 from N=3,189; 33.1%, and 75.0 IU (n=738 from N=3,189; 23.1% on the first day of stimulation; and 37.5 IU (n=465 from N=3,189; 14.6%, 50.0 IU (n=922 from N=3,189; 28.9%, and 75.0 IU (n=895 from N=3,189; 28.1% on the last day of stimulation. This noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of patients studied and the small dose increment (12.5 IU of the redesigned follitropin alfa pen allowed individualized treatment of women undergoing OI. Keywords: ovulation

  1. A CLASSIC FRAMEWORK OF ONLINE MARKETING TOOLS

    Directory of Open Access Journals (Sweden)

    Popa Adela Laura

    2015-07-01

    Full Text Available The present paper starts from the assumption that there is a tendency, especially among practitioners, to largely overlap concepts of online marketing and online advertising, thus considering that most online marketing tools aim at the aspect of value communication and promotion. This observation prompted us to try to delineate the categories of online marketing tools according to the traditional areas of marketing activity. Therefore, the paper aims to present the online marketing tools based on a different vision than the literature identified so far. Thus, it was intended to group the online marketing tools on the key components of the marketing activity and the presentation, for each, of certain software tools that support that. The way in which the analysis of online marketing tools was addressed is new and could be useful for defining a structured vision on the field. The paper aims both to analyze concepts specific to online marketing, and especially to carry out a delineation of categories of online marketing tools based on the key areas of marketing such as value creation, value delivery, value communication / promotion, customer relationship management and marketing research. To achieve the goal set for this paper we considered useful to address the issue from a dual perspective: from the perspective of the academic literature - books, studies found in scientific databases - which deal with the topic of online marketing and online marketing tools; and from the perspective of practitioners - studies posted on the Internet by the specialists in the field, respectively the analysis of websites of companies providing online marketing services. The intention was to combine the vision specific to theorists to that of practitioners in tackling the field specific to online marketing and online marketing tools. In order to synthesize the information presented in this paper, we also conducted a visual representation of the categories of online

  2. Post-operative recovery profile after laparoscopic cholecystectomy: a prospective, observational study of a multimodal anaesthetic regime

    DEFF Research Database (Denmark)

    Jensen, K; Kehlet, H; Lund, Claus

    2007-01-01

    functions. We investigated the feasibility and efficacy of a standardized, evidence-based anaesthesia/analgesic regime to identify residual problems in the early post-operative phase. METHODS: One hundred and thirty-four consecutive patients admitted for elective laparoscopic cholecystectomy at Hvidovre...

  3. [Susceptibility surveillance of clinical isolates to fluoroquinolone antimicrobial agents from 2003 to 2008: post-marketing study of prulifloxacin].

    Science.gov (United States)

    Kawai, Shin; Yoshida, Atsushi; Okazaki, Mitsuhiro; Tsujihara, Yoshito; Inuzuka, Kazuhisa; Takeuchi, Kazuhide; Yamashita, Naoko; Onodera, Makoto; Hiraishi, Toru; Ida, Takashi; Maebashi, Kazunori

    2010-06-01

    Yearly changes in the susceptibility of clinical isolates to ulifloxacin (UFX) and other fluoroquinolones were examined through surveys over 3 periods. In the first survey, 534 strains derived from 19 species were collected from clinical specimens during 6 months from December 2003 to May 2004. In the same way, 805 strains were collected from December 2005 to May 2006 in the second survey, and 863 strains were from December 2007 to May 2008 in the third survey. Over these 3 study periods, the susceptibilities of fluoroquinolones against methicillin-susceptible Staphylococcus aureus and Escherichia coli were decreased. The isolation frequency of levofloxacin-nonsusceptible strain was increased from 0% to 11.8% and from 14.6% to 20.8%, respectively. MIC90s of UFX against these pathogens were also increased, but its MIC90 for E. coli was 2 to 4 times lower than that of levofloxacin. On the other hand, the susceptibility of strains of Klebsiella pneumoniae to UFX was increased. Among the fluoroquinolones tested, UFX showed the most potent activity against Pseudomonas aeruginosa, and no changes in the MIC90s occurred during the surveillance. Although one strain of Streptococcus pneumoniae isolated in the third study period showed levofloxacin-resistance (MIC, 8 microg/mL), there were nearly no changes in the MIC90s of any agents tested including UFX against S. pneumoniae during the surveillance. As for other bacterial species, a tendency to increase in resistance to UFX was not observed. The activity of UFX against Salmonella spp. and Shigella spp. was superior/equal to those of fluoroquinolones tested.

  4. Surveillance on The Safety and Efficacy of Ambrisentan (Volibris Tablet 2.5 mg) in Patients with Pulmonary Arterial Hypertension in Real Clinical Practice: Post-marketing Surveillance (Interim Analysis Report).

    Science.gov (United States)

    Takahashi, Tomohiko; Hayata, Satoru; Kobayashi, Akihiro; Onaka, Yuna; Ebihara, Takeshi; Hara, Terufumi

    2018-03-01

    Pulmonary arterial hypertension (PAH) is an intractable and rare disease and the accumulation of clinical evidence under real-world setting is needed. A post-marketing surveillance for the endothelin receptor antagonist ambrisentan (Volibris tablet) has been conducted by all-case investigation since September 2010. This paper is an interim report on the safety and efficacy of ambrisentan in 702 patients with PAH. PAH patients aged 15 years or older were subjected to the analysis. The safety analysis by overall cases or stratification of patient backgrounds and the efficacy analysis were investigated. Regarding patient characteristics, the 702 patients subjected to safety analysis included 543 (77.4%) women and 546 (77.8%) patients at WHO functional class II/III. The mean observational time was 392.7 days. A total of 324 adverse drug reaction (ADR) occurred in 204 (29.1%) patients. Common ADRs (≥ 2%) included anemia (4.6%), peripheral edema (4.1%), headache (3.6%), edema and face edema (2.6% each), abnormal hepatic function (2.3%), and epistaxis (2.1%). There were 82 serious ADRs occurring in 44 (6.3%) patients (385 serious adverse events in 184 (26.2%) patients). Although 11 (1.6%) interstitial lung disease (ILD) cases were reported, all were observed in patients with disease that may contribute to ILD and therefore it is difficult to assess if ambrisentan was associated with these events. There was no difference in safety in relation to the presence/absence of connective tissue disease-related PAH (CTD-PAH) or combination therapy. Among 677 patients subjected to efficacy analysis, those in whom hemodynamic status was determined before and after treatment showed improvement in the mean pulmonary arterial pressure and pulmonary vascular resistance after treatment. The interim results showed safety consistent with the known profile of ambrisentan in terms of the types and frequencies of ADRs in patients with PAH in real clinical practice, in comparison with

  5. Malignancies in children and young adults on etanercept: summary of cases from clinical trials and post marketing reports.

    Science.gov (United States)

    Hooper, Michele; Wenkert, Deborah; Bitman, Bojena; Dias, Virgil C; Bartley, Yessenia

    2013-10-02

    , attributable to rates of Hodgkin lymphoma. Comparison to patients with similar burden of disease cannot be made; JIA, particularly very active disease, may be a risk factor for lymphoma. No increased malignancy reporting rate in the PMD relative to SEER was observed in the young-adult age group.

  6. Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: expert panel report.

    Science.gov (United States)

    Johanson, Chris-Ellyn; Balster, Robert L; Henningfield, Jack E; Schuster, Charles R; Anthony, James C; Barthwell, Andrea G; Coleman, John J; Dart, Richard C; Gorodetzky, Charles W; O'Keeffe, Charles; Sellers, Edward M; Vocci, Frank; Walsh, Sharon L

    2009-12-01

    The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and 11 recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized.

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

    Science.gov (United States)

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

    2015-07-01

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

  8. Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective.

    Science.gov (United States)

    Feltelius, Nils; Gedeborg, Rolf; Holm, Lennart; Zethelius, Björn

    2017-06-01

    The aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making. A workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance. The registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials. Quality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers.

  9. [Investigation of the factors that contribute to the onset of insomnia in hypertensive patients by using a post-marketing surveillance database].

    Science.gov (United States)

    Tanabe, Naoto; Fujita, Toshiharu; Fujii, Yosuke; Orii, Takao

    2011-01-01

    Many factors contribute to the onset of insomnia. However, few studies have identified the factors related to the onset of insomnia in hypertensive patients. We conducted a pharmacoepidemiologic study to examine the incidence of insomnia in hypertensive patients by using a post-marketing surveillance database. The insomnia onset was defined as the time of first prescription of hypnotics. The insomnia incidence rate in hypertensive patients under antihypertensive therapy was 0.77/100 person-years. The median insomnia onset date was 5 weeks. The insomnia type in 50.2% of the patients was difficulty in initiating sleep. We assessed the factors contributing to insomnia by using a nested case-control design. We selected 10 time-matched controls for every case. The hypotensive effect induced by antihypertensive therapy on the case group was lesser than that on the control group (pchannel blockers (OR, 0.62; 95% CI, 0.43-0.90) compared with angiotensin-converting enzyme inhibitors; female sex (OR, 1.76; 95% CI, 1.27-2.44); complication of gastric/duodenal disorders (OR, 2.35; 95% CI, 1.14-4.86) or musculoskeletal system/connective tissue disorders (OR, 2.43; 95% CI, 1.23-4.79); and concomitant antihypertensive therapy (OR, 0.44; 95% CI, 0.31-0.63). This study identified the potential factors that may help to predict insomnia onset in hypertensive patients under antihypertensive therapy.

  10. Viral Marketing

    OpenAIRE

    Sorina Raula Gîrboveanu; Silvia Puiu

    2008-01-01

    With consumers showing increasing resistance to traditional forms of advertising such as TV or newspaper ads, marketers have turned to alternate strategies, including viral marketing. Viral marketing exploits existing social networks by encouraging customers to share product information with their friends.In our study we are able to directly observe the effectiveness of person to person word of mouth advertising for hundreds of thousands of products for the first time

  11. REPRODUCING THE OBSERVED ABUNDANCES IN RCB AND HdC STARS WITH POST-DOUBLE-DEGENERATE MERGER MODELS-CONSTRAINTS ON MERGER AND POST-MERGER SIMULATIONS AND PHYSICS PROCESSES

    Energy Technology Data Exchange (ETDEWEB)

    Menon, Athira; Herwig, Falk; Denissenkov, Pavel A. [Department of Physics and Astronomy, University of Victoria, Victoria, BC V8P5C2 (Canada); Clayton, Geoffrey C.; Staff, Jan [Department of Physics and Astronomy, Louisiana State University, 202 Nicholson Hall, Tower Dr., Baton Rouge, LA 70803-4001 (United States); Pignatari, Marco [Department of Physics, University of Basel, Klingelbergstrasse 82, CH-4056 Basel (Switzerland); Paxton, Bill [Kavli Institute for Theoretical Physics and Department of Physics, Kohn Hall, University of California, Santa Barbara, CA 93106 (United States)

    2013-07-20

    The R Coronae Borealis (RCB) stars are hydrogen-deficient, variable stars that are most likely the result of He-CO WD mergers. They display extremely low oxygen isotopic ratios, {sup 16}O/{sup 18}O {approx_equal} 1-10, {sup 12}C/{sup 13}C {>=} 100, and enhancements up to 2.6 dex in F and in s-process elements from Zn to La, compared to solar. These abundances provide stringent constraints on the physical processes during and after the double-degenerate merger. As shown previously, O-isotopic ratios observed in RCB stars cannot result from the dynamic double-degenerate merger phase, and we now investigate the role of the long-term one-dimensional spherical post-merger evolution and nucleosynthesis based on realistic hydrodynamic merger progenitor models. We adopt a model for extra envelope mixing to represent processes driven by rotation originating in the dynamical merger. Comprehensive nucleosynthesis post-processing simulations for these stellar evolution models reproduce, for the first time, the full range of the observed abundances for almost all the elements measured in RCB stars: {sup 16}O/{sup 18}O ratios between 9 and 15, C-isotopic ratios above 100, and {approx}1.4-2.35 dex F enhancements, along with enrichments in s-process elements. The nucleosynthesis processes in our models constrain the length and temperature in the dynamic merger shell-of-fire feature as well as the envelope mixing in the post-merger phase. s-process elements originate either in the shell-of-fire merger feature or during the post-merger evolution, but the contribution from the asymptotic giant branch progenitors is negligible. The post-merger envelope mixing must eventually cease {approx}10{sup 6} yr after the dynamic merger phase before the star enters the RCB phase.

  12. REPRODUCING THE OBSERVED ABUNDANCES IN RCB AND HdC STARS WITH POST-DOUBLE-DEGENERATE MERGER MODELS—CONSTRAINTS ON MERGER AND POST-MERGER SIMULATIONS AND PHYSICS PROCESSES

    International Nuclear Information System (INIS)

    Menon, Athira; Herwig, Falk; Denissenkov, Pavel A.; Clayton, Geoffrey C.; Staff, Jan; Pignatari, Marco; Paxton, Bill

    2013-01-01

    The R Coronae Borealis (RCB) stars are hydrogen-deficient, variable stars that are most likely the result of He-CO WD mergers. They display extremely low oxygen isotopic ratios, 16 O/ 18 O ≅ 1-10, 12 C/ 13 C ≥ 100, and enhancements up to 2.6 dex in F and in s-process elements from Zn to La, compared to solar. These abundances provide stringent constraints on the physical processes during and after the double-degenerate merger. As shown previously, O-isotopic ratios observed in RCB stars cannot result from the dynamic double-degenerate merger phase, and we now investigate the role of the long-term one-dimensional spherical post-merger evolution and nucleosynthesis based on realistic hydrodynamic merger progenitor models. We adopt a model for extra envelope mixing to represent processes driven by rotation originating in the dynamical merger. Comprehensive nucleosynthesis post-processing simulations for these stellar evolution models reproduce, for the first time, the full range of the observed abundances for almost all the elements measured in RCB stars: 16 O/ 18 O ratios between 9 and 15, C-isotopic ratios above 100, and ∼1.4-2.35 dex F enhancements, along with enrichments in s-process elements. The nucleosynthesis processes in our models constrain the length and temperature in the dynamic merger shell-of-fire feature as well as the envelope mixing in the post-merger phase. s-process elements originate either in the shell-of-fire merger feature or during the post-merger evolution, but the contribution from the asymptotic giant branch progenitors is negligible. The post-merger envelope mixing must eventually cease ∼10 6 yr after the dynamic merger phase before the star enters the RCB phase

  13. Direct observation and mechanism for enhanced field emission sites in platinum ion implanted/post-annealed ultrananocrystalline diamond films

    Energy Technology Data Exchange (ETDEWEB)

    Panda, Kalpataru, E-mail: panda@afm.eei.eng.osaka-u.ac.jp, E-mail: phy.kalpa@gmail.com; Inami, Eiichi; Sugimoto, Yoshiaki [Graduate School of Engineering, Osaka University, 2-1, Yamada-Oka, Suita, Osaka 565-0871 (Japan); Sankaran, Kamatchi J.; Tai, Nyan Hwa [Department of Materials Science and Engineering, National Tsing Hua University, Hsinchu 30013, Taiwan (China); Lin, I-Nan, E-mail: inanlin@mail.tku.edu.tw [Department of Physics, Tamkang University, Tamsui 251, Taiwan (China)

    2014-10-20

    Enhanced electron field emission (EFE) properties for ultrananocrystalline diamond (UNCD) films upon platinum (Pt) ion implantation and subsequent post-annealing processes is reported, viz., low turn-on field of 4.17 V/μm with high EFE current density of 5.08 mA/cm{sup 2} at an applied field of 7.0 V/μm. Current imaging tunneling spectroscopy (CITS) mode in scanning tunneling spectroscopy directly revealed the increased electron emission sites density for Pt ion implanted/post-annealed UNCD films than the pristine one. The high resolution CITS mapping and local current–voltage characteristic curves demonstrated that the electrons are dominantly emitted from the diamond grain boundaries and Pt nanoparticles.

  14. Direct observation and mechanism for enhanced field emission sites in platinum ion implanted/post-annealed ultrananocrystalline diamond films

    International Nuclear Information System (INIS)

    Panda, Kalpataru; Inami, Eiichi; Sugimoto, Yoshiaki; Sankaran, Kamatchi J.; Tai, Nyan Hwa; Lin, I-Nan

    2014-01-01

    Enhanced electron field emission (EFE) properties for ultrananocrystalline diamond (UNCD) films upon platinum (Pt) ion implantation and subsequent post-annealing processes is reported, viz., low turn-on field of 4.17 V/μm with high EFE current density of 5.08 mA/cm 2 at an applied field of 7.0 V/μm. Current imaging tunneling spectroscopy (CITS) mode in scanning tunneling spectroscopy directly revealed the increased electron emission sites density for Pt ion implanted/post-annealed UNCD films than the pristine one. The high resolution CITS mapping and local current–voltage characteristic curves demonstrated that the electrons are dominantly emitted from the diamond grain boundaries and Pt nanoparticles.

  15. Evaluation of nonmemory cognitive parameters in psychiatric patients? pre- and post-electroconvulsive therapy: An observational study

    OpenAIRE

    Prakash, Jyoti; Srivastava, Kalpana; Manandhar, Pradeep; Saha, Amitabh

    2015-01-01

    Introduction: Possibility of cognitive side effects has made electroconvulsive therapy (ECT) questionable. Variable deficits have been debated in memory cognition. Pattern of changes in nonmemory cognition pre- and post-ECT is not clear. Methodology: Forty patients undergoing ECT were studied on nonmemory cognitive parameters before ECT, after a course of ECT, and after 4 weeks of last. ECT. Results: Nonmemory cognition improved during the course of ECT and over 4 weeks of ECT. Co...

  16. THE GRANGER CAUSALITY TESTS FOR THE FIVE ASEAN COUNTRIES STOCK MARKETS AND MACROECONOMIC VARIABLES DURING AND POST THE 1997 ASIAN FINANCIAL CRISIS

    Directory of Open Access Journals (Sweden)

    Adwin Surja Atmadja

    2005-01-01

    Full Text Available This study seeks to examine the existence of Granger-causality among stock prices indices and macroeconomic variables in five ASEAN countries, Indonesia; Malaysia; the Philippines; Singapore; and Thailand with particular attention to the 1997 Asian financial crisis and period onwards. Using monthly time series data of the countries, a Granger-causality test based on the vector autoregressive (VAR analytical framework was employed to empirically reveal the causality among the variables. This research finds that there were few Granger causalities found between the country's wtock price index and macroeconomic variables. This indicates that the linkages between domestic stock price movements and macroeconomic factors were very. Due to that, the ASEAN stock markets were crelatively unable to efficiently capture changes in economic fundamentals during the observation period in most of the countries in accordance to the literature in emerging stock markets, and that the influence of specific macroeconomic factors on the domestic economies differ across countries. This also implies that the stock markets do not seem to have played a significant role in most countries' economies, and macroeconomic variables are unlikely to be appropriate indicators to predict not only the future behaviour of other macroeconomic variables, but also that of the stock market price indices. Abstract in Bahasa Indonesia : Makalah ini mencoba untuk menganalisis keberadaan Granger-causality antara indeks harga saham dan variabel-variabel ekonomi makro di lima negara ASEAN, yaitu Indonesia; Malaysia; Filipina; Singapore; dan Thailand yang berfokus pada periode terjadinya krisis keuangan Asia pada tahun 1997 dan sesudahnya. Dengan mempergunakan data time series bulanan dari setiap negara tersebut, tes Granger-causality yang didasarkan pada kerangka analisa VAR (vector autoregressive diaplikasikan untuk mengungkap secara empiris hubungan kausal antar variabel. Dari hasil tes

  17. Primary observation on adherent function of bone marrow stromal cells in mice post combined radiation-burn injury

    International Nuclear Information System (INIS)

    Chen Xinghua; Luo Chengji; Guo Chaohua; Wang Ping; Deng Xuecai

    1999-01-01

    Objective: To investigate the adherent function of bone marrow stromal cells in hematopoietic inductive microenvironment post combined radiation-burn injury. Methods: The expression of cell adhesion molecules including vascular cell adhesion molecule-1 (VCAM-1), fibro-connection (Fn), laminin (Ln) and collagen type IV (Col IV) on bone marrow stromal cells cultured in vitro was detected by flow cytometry and the binding capacity of bone marrow mononuclear cells to stromal cell adherence layer was tested by cell binding assay and cell binding blocking assay respectively from mice treated with 5.0 Gy γ-ray 15% of total body surface area (TBSA), third-degree burn injury and combined irradiation-burn injury, respectively. Results: 1. The expression levels of molecules mentioned above in burn-injured mice were the highest. The molecules levels in control mice were greater than those in radiation-injured mice, which were lower than those in mice with combined radiation-burn injury. 2. The binding capacity of stromal cell adherence layer in burn-injured mice was greater than that in control mice, and significantly increased from 3 to 7 days post injury as compared with that in controls, radiation-injured mice and combined radiation-burn-injured mice, respectively (P < 0.05-0.01). Contrarily, the capacity of binding in the radiation-injured and combined radiation-burn-injured mice was the lowest from 3 to 7 days post injury. 3. The binding rate of bone marrow mononuclear cells to stromal cell adherence layer descended in different degrees after pre-treatment with monoclonal antibodies directed to VCAM-1, Fn, Ln, or Col IV respectively or VCAM-1 combined with anti-Fn, anti-Ln or anti-Col IV, respectively, in stromal cell adherence layer. Conclusion: The damage of cell adherent function for bone marrow hematopoietic inductive microenvironment post combined radiation-burn injury might be one of the important factors in hematopoietic disorder in combined radiation-burn injury

  18. To grade or not to grade: balancing formative and summative assessment in post-16 teacher trainee observations

    OpenAIRE

    Matthews, Richard; Noyes, Andrew

    2016-01-01

    The issue of whether trainee teachers in the post-16 sector should have their classroom practice graded has been debated for a number of years. The case for training courses retaining an emphasis on written and verbal ‘developmental’ feedback at the expense of ‘judgements’ appears to be lost. This article is set within the context of an ever-growing culture of performativity in English further education colleges, where grading is regarded as an essential requirement to ensure high quality tea...

  19. Evaluation of nonmemory cognitive parameters in psychiatric patients' pre- and post-electroconvulsive therapy: An observational study

    Directory of Open Access Journals (Sweden)

    Jyoti Prakash

    2015-01-01

    Full Text Available Introduction: Possibility of cognitive side effects has made electroconvulsive therapy (ECT questionable. Variable deficits have been debated in memory cognition. Pattern of changes in nonmemory cognition pre- and post-ECT is not clear. Methodology: Forty patients undergoing ECT were studied on nonmemory cognitive parameters before ECT, after a course of ECT, and after 4 weeks of last. ECT. Results: Nonmemory cognition improved during the course of ECT and over 4 weeks of ECT. Conclusions: ECT does not affect the nonmemory cognition adversely.

  20. SPORT MARKETING

    Directory of Open Access Journals (Sweden)

    Omer Špirtović

    2010-03-01

    Full Text Available Word „marketing“ comes from AngloSaxon linguistic domain and implies in a narrow sense the market. Under marketing, we consider certain process, which should create and solve relations of exchange between manufacturers on one side, and consumers on the other. Discussion about sport marketing implies its theoretical definition and generalization, and then its actual definition in sport environment. Sport marketing belongs to business function of sport organization and represents primaly an economical process of connecting produktion (sport organizations with sportsmen and coaches and consumption (sport and other public. Sport marketing is the reality in sport today, and cannot be observed as fashionabless of capitalistic production. Today is almost impossible for sport organization to make business without its business part called sport marketing if it wants to survive in sport arena.

  1. Safety and Effectiveness of Once-Daily Tadalafil (5 mg Therapy in Korean Men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms in a Real-World Clinical Setting: Results from a Post- Marketing Surveillance Study

    Directory of Open Access Journals (Sweden)

    Ji Eon Won

    2018-05-01

    Full Text Available Purpose: The aim of this study was to investigate the safety and effectiveness of tadalafil 5 mg once daily (quaque die [everyday], QD among Korean men with benign prostatic hyperplasia (BPH/lower urinary tract symptoms (LUTS in a real-world clinical setting. Materials and Methods: This was a single-country, prospective, observational cohort study in which patients newly prescribed tadalafil 5 mg QD for the treatment of BPH/LUTS were followed-up for 12±2 or 24±2 weeks, or to the last treatment, during post-marketing surveillance. Safety was evaluated in terms of the frequency of treatment-emergent adverse events (TEAEs and serious adverse events (SAEs. Effectiveness was assessed by changes in the International Prostate Symptom Score (IPSS from baseline to each endpoint. Results: All patients receiving ≥1 dose of tadalafil 5 mg QD (N=637 were included in the safety population. Two percent of patients (n=13 experienced 15 TEAEs of mild (n=10; 66.7% or moderate (n=5; 33.3% severity. No severe TEAEs and no SAEs were reported. Effectiveness evaluations included all patients receiving tadalafil who had both baseline and endpoint observations (12-week, N=265; 24-week, N=44. Compared with baseline, the mean IPSS total score (±standard error significantly improved by 4.7±0.3 and 6.4±0.7 points at the 12- and 24-week endpoints, respectively (p<0.0001, with significant improvements also observed on the storage, voiding, and quality of life subscores. In total, 69.1% of the patients had a clinically meaningful ≥3-point improvement in the IPSS total score. Conclusions: Tadalafil 5 mg QD was well tolerated and effective in Korean men with BPH/LUTS in a real-world clinical setting.

  2. Effects of action observation therapy on hand dexterity and EEG-based cortical activation patterns in patients with post-stroke hemiparesis.

    Science.gov (United States)

    Kuk, Eun-Ju; Kim, Jong-Man; Oh, Duck-Won; Hwang, Han-Jeong

    2016-10-01

    Previous reports have suggested that action observation training (AOT) is beneficial in enhancing the early learning of new motor tasks; however, EEG-based investigation has received little attention for AOT. The purpose of this study was to illustrate the effects of AOT on hand dexterity and cortical activation in patients with post-stroke hemiparesis. Twenty patients with post-stroke hemiparesis were randomly divided into either the experimental group (EG) or control group (CG), with 10 patients in each group. Prior to the execution of motor tasks (carrying wooden blocks from one box to another), subjects in the EG and CG observed a video clip displaying the execution of the same motor task and pictures showing landscapes, respectively. Outcome measures included the box and block test (BBT) to evaluate hand dexterity and EEG-based brain mapping to detect changes in cortical activation. The BBT scores (EG: 20.50 ± 6.62 at pre-test and 24.40 ± 5.42 at post-test; CG: 20.20 ± 6.12 at pre-test and 20.60 ± 7.17 at post-test) revealed significant main effects for the time and group and significant time-by-group interactions (p < 0.05). For the subjects in the EG, topographical representations obtained with the EEG-based brain mapping system were different in each session of the AOT and remarkable changes occurred from the 2nd session of AOT. Furthermore, the middle frontal gyrus was less active at post-test than at pre-test. These findings support that AOT may be beneficial in altering cortical activation patterns and hand dexterity.

  3. The safety and quality of pork and poultry meat imports for the common European market received at border inspection post Hamburg Harbour between 2014 and 2015.

    Science.gov (United States)

    Jansen, Wiebke; Woudstra, Svenja; Müller, Anja; Grabowski, Nils; Schoo, Gundela; Gerulat, Bettina; Klein, Günter; Kehrenberg, Corinna

    2018-01-01

    Though imports of products of animal origin into the European Union (EU) have to comply with legal requirements and quality standards of the community, food consignment rejections at external EU borders have been increasing in recent years. This study explored microbiological metrics according to national target and critical values valid for samples at consumer level of 498 fresh poultry meat and 136 fresh pork filets from consignments subjected to physical checks during clearing at the border inspection post Hamburg harbour between January 2014 and December 2015 with ISO standard methods. Quantitative results indicated that critical thresholds for aerobic counts, Enterobacteriaceae, and E. coli were never surpassed. Merely for staphylococci, one poultry sample (0.2%) and 10 pork samples (9.3%) exceeded the critical limit (3.7 log cfu/g). However, qualitative analyses revealed that, Staphylococcus aureus was present in 16% and 10% of all poultry and pork samples, respectively, though no methicillin-resistant Staphylococcus aureus could be confirmed. Moreover, E. coli was present in 50% and 67% of all pork and poultry samples, respectively, and thereof 33 isolates were confirmed as extended-spectrum β-lactamase-producing E. coli. Only 1.2% of the poultry samples were unacceptable due to the presence of Salmonella spp., whereas they were not detected in any pork sample. Campylobacter spp. were not detected in any sample. Though imported pork and poultry meat complies mostly with national market requirements, it might pose a potential risk to public health, especially for a direct or indirect foodborne transmission of imported, uncommon strains of zoonotic bacteria.

  4. Repeat confirmatory testing for persons with discordant whole blood and oral fluid rapid HIV test results: findings from post marketing surveillance.

    Science.gov (United States)

    Wesolowski, Laura G; Mackellar, Duncan A; Ethridge, Steven F; Zhu, Julia H; Owen, S Michele; Sullivan, Patrick S

    2008-02-06

    Reactive oral fluid and whole blood rapid HIV tests must be followed with a confirmatory test (Western blot (WB), immunofluorescent assay (IFA) or approved nucleic acid amplification test (NAAT)). When the confirmatory result is negative or indeterminate (i.e. discordant with rapid result), repeat confirmatory testing should be conducted using a follow-up specimen. Previous reports have not described whether repeat testing adequately resolves the HIV-infection status of persons with discordant results. Post-marketing surveillance was conducted in 368 testing sites affiliated with 14 state and 2 city health departments from August 11, 2004 to June 30, 2005 and one health department through December 31, 2005. For persons with discordant results, data were collected on demographics, risk behaviors, HIV test results and specimen types. Persons with repeat confirmatory results were classified as HIV-infected or uninfected. Regression models were created to assess risk factors for not having repeat testing. Of 167,371 rapid tests conducted, 2589 (1.6%) were reactive: of these, 2417 (93%) had positive WB/IFA, 172 (7%) had negative or indeterminate WB/IFA. Of 89/172 (52%) persons with a repeat confirmatory test: 17 (19%) were HIV-infected, including 3 with indeterminate WB and positive NAAT; 72 (81%) were uninfected, including 12 with repeat indeterminate WB. Factors associated with HIV-infection included having an initial indeterminate WB/IFA (vs. negative) (ptest [adjusted OR 2.6, 95% CI (1.3, 4.9)]. Though only half of persons with discordant results had repeat confirmatory testing, of those who did, nearly one in five were HIV-infected. These findings underscore the need for rapid HIV testing programs to increase repeat confirmatory testing for persons with discordant results. Because of the lower sensitivity of oral fluid WBs, confirmatory testing following a reactive rapid test should be conducted using serum or plasma, when possible.

  5. [Safety and effectiveness of pemetrexed in patients with non-small cell lung cancer in Japan - analysis of post-marketing surveillance].

    Science.gov (United States)

    Okubo, Sumiko; Kobayashi, Noriko; Taketsuna, Masanori; Kaneko, Naoya; Enatsu, Sotaro; Nishiuma, Shinichi

    2014-04-01

    The safety and effectiveness of pemetrexed(PEM)in patients with non-small cell lung cancer(NSCLC)were reviewed using data from post-marketing surveillance. Among 699 patients registered from June 2009 to May 2010, 683 patients were analyzed(343, first-line therapy: 340, second-line therapy or beyond). Patient backgrounds were as follows: median age=65 years(16.1%B75 years old); 64.7% male; 91.9% performance status 0-1; 83.2% Stage IV; 99.0% non-squamous cell cancer. Also, 86% of the first-line and 20% of the second-line cohort were receiving a concomitant anti-cancer drug(mostly platinum agents). The incidence rate of adverse drug reactions(ADR)was 76.7%, including serious cases(18.0%). The most common ADRs were decreased white blood cell count(26.8%), decreased neutrophil count(25.3%), anemia(19.2%), decreased platelet count(17.0%), and nausea(23.0%). The incidence of interstitial lung disease, which is a concern during chemotherapy, was 2.6%. Peripheral neuropathy and alopecia, events influencing a patient's quality of life, were less than 1%. The estimated median survival time was 23.2 months[95%CI: 19.8 months-not calculable]in the first-line cohort, and 11.8 months[95% CI: 10.5-13.7 months]in the B second-line cohort. The surveillance results showed no apparent difference in total ADRs in this current study compared to the safety profile established in clinical trials previously conducted in Japan and overseas. These results demonstrate the safety and effectiveness of PEM treatment for NSCLC patients in daily clinical settings.

  6. Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™).

    Science.gov (United States)

    Shin, Son Moon; Kim, Chun Soo; Karkada, Naveen; Liu, Aixue; Jayadeva, Girish; Han, Htay Htay

    2016-10-02

    According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation. Healthy infants aged ≥6 weeks were enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of ≥4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) was then assessed for up to 30 days along with the incidence of serious adverse events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug could not be ruled out) were identified. A total of 3040 children (mean age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% infants and 8.6% had an ADR. The most commonly seen expected AE was irritability (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced an ADR. The most commonly seen unexpected AE was upper respiratory tract infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to vaccination. We conclude that this 6-year surveillance showed both formulations of RIX4414 to have acceptable safety profiles when administered to Korean infants according to local prescribing recommendations and current clinical practice.

  7. Is patient-reported outcome improved by nalfurafine hydrochloride in patients with primary biliary cholangitis and refractory pruritus? A post-marketing, single-arm, prospective study.

    Science.gov (United States)

    Yagi, Minami; Tanaka, Atsushi; Namisaki, Tadashi; Takahashi, Atsushi; Abe, Masanori; Honda, Akira; Matsuzaki, Yasushi; Ohira, Hiromasa; Yoshiji, Hitoshi; Takikawa, Hajime

    2018-04-16

    Patients with primary biliary cholangitis (PBC) frequently suffer from pruritus, which can severely impair their health-related quality of life (HRQOL). Nalfurafine hydrochloride, a selective κ-opioid receptor agonist, was recently approved in Japan for refractory pruritus in patients with chronic liver diseases, but it still remains unclear whether this treatment improves the patient-reported outcome (PRO) in PBC patients with refractory pruritus. Herein, we conducted a multicenter, post-marketing, single-arm prospective study to investigate the efficacy of nalfurafine in terms of PRO, and the associations of the efficacy with any clinical characteristics. After screening for pruritus in 496 patients with PBC using PBC-40 and the visual analog scale (VAS), we identified 141 patients with moderate to severe pruritus; these were invited to participate in the study. The participants received 2.5 μg nalfurafine once daily for 12 weeks, and pruritus and HRQOL were assessed in week 12 of this treatment. Generic HRQOL, short form 36, blood chemistries, and serum autotaxin levels were also measured at baseline and at week 12. Forty-four patients participated in this study. The mean PBC-40 itch domain scores and VAS declined during the study period, from 8.56 to 7.63 (P = 0.041) and from 42.9 to 29.3 (P = 0.001) at baseline and at week 12, respectively, indicating a significant effect of nalfurafine. The other domains of PBC-40 and all domains of SF-36 were not significantly altered by this treatment. We failed to find any association between the change in VAS and PBC-40 itch scores and any clinical variable. Serum autotaxin levels were significantly increased during the study period. This study demonstrated that nalfurafine improved pruritus in patients with PBC, independent of their clinical characteristics, but had a limited effect on the PRO.

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

    International Nuclear Information System (INIS)

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

    2015-01-01

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

  9. Emotional impact of severe post-partum haemorrhage on women and their partners: an observational, case-matched, prospective, single-centre pilot study.

    Science.gov (United States)

    Ricbourg, Aude; Gosme, Christelle; Gayat, Etienne; Ventre, Chloé; Barranger, Emmanuel; Mebazaa, Alexandre

    2015-10-01

    This observational, matched-control, prospective, single-centre study sought to estimate the emotional impact of post-partum haemorrhage (PPH) on women and their partners, including its influences on post-traumatic stress disorder (PTSD), postpartum depression and the mother/child relationship. All consecutive women who were admitted for PPH from December 2010 through December 2011 and their partners were screened for eligibility. Emotional impact was assessed using three self-reported questionnaires (Impact of Event Scale-Revised to assess PTSD, Edinburgh Post Natal Depression Scale to assess post-natal depression and Mother-Infant Bonding Scale to assess the relationship between mother and child). Each PPH patient was matched with a control woman for whom the delivery was not complicated by PPH. The results showed (a) that women with PPH and their partners were more likely to report symptoms related to PTSD compared with controls, (b) that women with PPH were less likely to suffer from postnatal depression and (c) that there was no difference in the mother/child relationship between women with PPH and controls. PPH is associated with a high incidence of PTSD-related symptoms in both women and their partners. PTSD in the context of PPH is likely an under-recognised phenomenon by health care professionals. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  10. Safety and Effectiveness of Once-Daily Tadalafil (5 mg) Therapy in Korean Men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms in a Real-World Clinical Setting: Results from a Post-Marketing Surveillance Study.

    Science.gov (United States)

    Won, Ji Eon; Chu, Ji Yeon; Choi, Hyunah Caroline; Chen, Yun; Park, Hyun Jun; Dueñas, Héctor José

    2018-05-01

    The aim of this study was to investigate the safety and effectiveness of tadalafil 5 mg once daily (quaque die [everyday], QD) among Korean men with benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) in a real-world clinical setting. This was a single-country, prospective, observational cohort study in which patients newly prescribed tadalafil 5 mg QD for the treatment of BPH/LUTS were followed-up for 12±2 or 24±2 weeks, or to the last treatment, during post-marketing surveillance. Safety was evaluated in terms of the frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Effectiveness was assessed by changes in the International Prostate Symptom Score (IPSS) from baseline to each endpoint. All patients receiving ≥1 dose of tadalafil 5 mg QD (N=637) were included in the safety population. Two percent of patients (n=13) experienced 15 TEAEs of mild (n=10; 66.7%) or moderate (n=5; 33.3%) severity. No severe TEAEs and no SAEs were reported. Effectiveness evaluations included all patients receiving tadalafil who had both baseline and endpoint observations (12-week, N=265; 24-week, N=44). Compared with baseline, the mean IPSS total score (±standard error) significantly improved by 4.7±0.3 and 6.4±0.7 points at the 12- and 24-week endpoints, respectively (peffective in Korean men with BPH/LUTS in a real-world clinical setting. Copyright © 2018 Korean Society for Sexual Medicine and Andrology.

  11. Nondestructive observation of teeth post core-space using optical coherence tomography: comparison with microcomputed tomography and live images

    Science.gov (United States)

    Minamino, Takuya; Mine, Atsushi; Matsumoto, Mariko; Sugawa, Yoshihiko; Kabetani, Tomoshige; Higashi, Mami; Kawaguchi, Asuka; Ohmi, Masato; Awazu, Kunio; Yatani, Hirofumi

    2015-10-01

    No previous reports have observed inside the root canal using both optical coherence tomography (OCT) and x-ray microcomputed tomography (μCT) for the same sample. The purpose of this study was to clarify both OCT and μCT image properties from observations of the same root canal after resin core build-up treatment. As OCT allows real-time observation of samples, gap formation may be able to be shown in real time. A dual-cure, one-step, self-etch adhesive system bonding agent, and dual-cure resin composite core material were used in root canals in accordance with instructions from the manufacturer. The resulting OCT images were superior for identifying gap formation at the interface, while μCT images were better to grasp the tooth form. Continuous tomographic images from real-time OCT observation allowed successful construction of a video of the resin core build-up procedure. After 10 to 12 s of light curing, a gap with a clear new signal occurred at the root-core material interface, proceeding from the coronal side (6 mm from the cemento-enamel junction) to the apical side of the root.

  12. Are All Marketers Liars ?

    OpenAIRE

    Sunanto, Sandra

    2006-01-01

    Today, consumers demand higher levels of quality, reliability, and durability of product A marketer must understand consumer's expectations and try to satisfy those and retain the consumer's loyalty.The shift from golden age of marketing to post age creates new challenge for marketer because consumers do not trust television commercials anymore. In this age consumers love being told a storyTo tell a story marketer must understand what is a great story. A great story must true, authentic, trus...

  13. Misalignment between Post-Secondary Education Demand and Labour Market Supply: Preliminary Insight from Young Adults on the Evolving School to Work Transition

    Science.gov (United States)

    Graham, John R.; Shier, Micheal L.; Eisenstat, Marilyn

    2014-01-01

    Most research on labour market outcomes and higher education finds a positive relationship. This qualitative research sought to better understand how higher educational attainment contributes to employment outcomes from a subsample (n = 15) of a larger study (N = 36) on youth labour market attachment among minority, low socioeconomic status young…

  14. Post-operative observation of ilio-apophyseal transplants on the basis of radiography, computed tomography, autoradiography and histological assessment

    International Nuclear Information System (INIS)

    Klatt, U.

    1987-01-01

    A study in 25 rabbits, in which the acetabular roof was reinforced by inserting a wedge-shaped autologous tissue fragment of the apophysis, led to the following conclusions: That complete healing and ossification of the implant took place within the observation period; that radiography, computed tomography, autoradiography and histology consistently provided evidence in confirmation of ossification; that a wedge-shaped fragment of apophyseal cartilage is a suitable material for plastic surgery in the acetabular roof. (TRV) [de

  15. Repeat confirmatory testing for persons with discordant whole blood and oral fluid rapid HIV test results: findings from post marketing surveillance.

    Directory of Open Access Journals (Sweden)

    Laura G Wesolowski

    Full Text Available BACKGROUND: Reactive oral fluid and whole blood rapid HIV tests must be followed with a confirmatory test (Western blot (WB, immunofluorescent assay (IFA or approved nucleic acid amplification test (NAAT. When the confirmatory result is negative or indeterminate (i.e. discordant with rapid result, repeat confirmatory testing should be conducted using a follow-up specimen. Previous reports have not described whether repeat testing adequately resolves the HIV-infection status of persons with discordant results. METHODOLOGY: Post-marketing surveillance was conducted in 368 testing sites affiliated with 14 state and 2 city health departments from August 11, 2004 to June 30, 2005 and one health department through December 31, 2005. For persons with discordant results, data were collected on demographics, risk behaviors, HIV test results and specimen types. Persons with repeat confirmatory results were classified as HIV-infected or uninfected. Regression models were created to assess risk factors for not having repeat testing. PRINCIPAL FINDINGS: Of 167,371 rapid tests conducted, 2589 (1.6% were reactive: of these, 2417 (93% had positive WB/IFA, 172 (7% had negative or indeterminate WB/IFA. Of 89/172 (52% persons with a repeat confirmatory test: 17 (19% were HIV-infected, including 3 with indeterminate WB and positive NAAT; 72 (81% were uninfected, including 12 with repeat indeterminate WB. Factors associated with HIV-infection included having an initial indeterminate WB/IFA (vs. negative (p<0.001 and having an initial oral fluid WB (vs. serum (p<0.001. Persons who had male-female sex (vs. male-male sex were at increased risk for not having a repeat test [adjusted OR 2.6, 95% CI (1.3, 4.9]. CONCLUSIONS: Though only half of persons with discordant results had repeat confirmatory testing, of those who did, nearly one in five were HIV-infected. These findings underscore the need for rapid HIV testing programs to increase repeat confirmatory testing for

  16. Safety and Efficacy of Teneligliptin in Patients with Type 2 Diabetes Mellitus and Impaired Renal Function: Interim Report from Post-marketing Surveillance.

    Science.gov (United States)

    Haneda, Masakazu; Kadowaki, Takashi; Ito, Hiroshi; Sasaki, Kazuyo; Hiraide, Sonoe; Ishii, Manabu; Matsukawa, Miyuki; Ueno, Makoto

    2018-06-01

    Teneligliptin is a novel oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus (T2DM). Safety and efficacy of teneligliptin have been demonstrated in clinical studies; however, data supporting its use in patients with moderate or severe renal impairment are limited. This interim analysis of a post-marketing surveillance of teneligliptin, exploRing the long-term efficacy and safety included cardiovascUlar events in patients with type 2 diaBetes treated bY teneligliptin in the real-world (RUBY), aims to verify the long-term safety and efficacy of teneligliptin in Japanese patients with T2DM and impaired renal function. For this analysis, we used the data from case report forms of the RUBY surveillance between May 2013 and June 2017. The patients were classified into G1-G5 stages of chronic kidney disease according to estimated glomerular filtration rate (eGFR) at initiation of teneligliptin treatment. Safety and efficacy were evaluated in these subgroups. Patients on dialysis were also assessed. Safety was assessed from adverse drug reactions (ADRs). Glycemic control was evaluated up to 2 years after teneligliptin initiation. A total of 11,677 patients were enrolled in the surveillance and 11,425 patient case-report forms were collected for the interim analysis. The incidence of ADRs in each subgroup was 2.98-6.98% of patients, with no differences in the ADR profile (including hypoglycemia and renal function ADRs) between subgroups. At 1 and 2 years after starting teneligliptin, the least-squares mean change in HbA1c adjusted to the baseline was - 0.68 to - 0.85% and - 0.71 to - 0.85% across the eGFR groups, respectively. Treatment with teneligliptin in patients on dialysis reduced or tended to reduce glycated albumin levels [- 2.29%, (p < 0.001) after 1 year; - 1.64%, (p = 0.064) after 2 years]. During long-term treatment, teneligliptin was generally well tolerated in patients with any stage of renal impairment from

  17. Relationship of Eating Patterns and Metabolic Parameters, and Teneligliptin Treatment: Interim Results from Post-marketing Surveillance in Japanese Type 2 Diabetes Patients.

    Science.gov (United States)

    Kadowaki, Takashi; Haneda, Masakazu; Ito, Hiroshi; Sasaki, Kazuyo; Hiraide, Sonoe; Matsukawa, Miyuki; Ueno, Makoto

    2018-06-01

    Healthy eating is a critical aspect of the prevention and management of type 2 diabetes (T2DM). Disrupted eating patterns can result in poor glucose control and increase the likelihood of diabetic complications. Teneligliptin inhibits dipeptidyl peptidase-4 activity for 24 h and suppresses postprandial hyperglycemia after all three daily meals. This interim analysis of data from the large-scale post-marketing surveillance of teneligliptin (RUBY) in Japan examined eating patterns and their relationship with metabolic parameters and diabetic complications. We also examined whether eating patterns affected safety and efficacy of teneligliptin. We analyzed baseline data from survey forms collected in RUBY between May 2013 and June 2017, including patient characteristics, metabolic parameters, and eating patterns (eating three meals per day or not; timing of evening meal) before teneligliptin treatment was initiated. Safety and efficacy of 12 months' teneligliptin (20-40 mg/day) treatment was assessed. Data from 10,532 patients were available for analysis. Most patients who did not eat three meals per day (n  =757) or who ate their evening meal after 10 PM (n  =206) were 64 years old or younger. At baseline, glycated hemoglobin (HbA1c), fasting blood glucose, triglycerides, total and low-density lipoprotein cholesterol, body mass index, alanine aminotransferase, and aspartate aminotransferase levels were higher in those patients who did not eat three meals per day (p < 0.05) or who ate their evening meal late (p < 0.05). Diabetic complications were more common in patients who did not eat three meals per day. Treatment with teneligliptin reduced HbA1c over 6 or 12 months across all eating patterns, with a low incidence of adverse drug reactions. Eating patterns may be associated with altered metabolic parameters and diabetic complications among Japanese patients with T2DM. Teneligliptin may be well tolerated and improve hyperglycemia in patients

  18. Post-marketing safety and effectiveness evaluation of the intravenous anti-influenza neuraminidase inhibitor peramivir. II: a pediatric drug use investigation.

    Science.gov (United States)

    Komeda, Takuji; Ishii, Shingo; Itoh, Yumiko; Ariyasu, Yasuyuki; Sanekata, Masaki; Yoshikawa, Takayoshi; Shimada, Jingoro

    2015-03-01

    Peramivir is the only intravenous formulation among anti-influenza neuraminidase inhibitors currently available. Peramivir was approved for manufacturing and marketing in Japan in January 2010. In October 2010, an additional indication for pediatric use was approved. We conducted a pediatric drug use investigation of peramivir from October 2010 to February 2012 and evaluated its real-world safety and effectiveness in pediatric patients. We collected the data of 1254 peramivir-treated pediatric patients from 161 facilities across Japan and examined the safety in 1199 patients and effectiveness in 1188 patients. In total, 245 adverse events were observed with an incidence rate of 14.01% (168/1199). Of these, 115 events were adverse drug reactions (ADRs) with an incidence rate of 7.67% (92/1199). Common ADRs were diarrhea and abnormal behavior, with incidence rates of 2.50% (30/1199) and 2.25% (27/1199), respectively. Fourteen serious ADRs were observed in 12 patients (1.00%), including 5 cases each of abnormal behavior and neutrophil count decreased. While 87.0% (100 events) of ADRs occurred within 3 days after the initiation of peramivir administration, 87.8% (101 events) resolved or improved within 7 days after onset. Multivariate analyses indicated that the presence or absence of underlying diseases/complications was significantly related to ADR incidence. With regard to effectiveness, the median time to alleviation of both influenza symptoms and fever was 3 days, including the first day of administration. Thus, this study confirms the pediatric safety of peramivir without any concerns about effectiveness under routine clinical settings. Copyright © 2014 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  19. Market Power in Hydro-Thermal Supply

    International Nuclear Information System (INIS)

    Edin, Karl-Axel

    2006-12-01

    Despite having had a deregulated electricity market in Sweden for over ten years we still need to increase our understanding as to how deregulated electricity markets actually work and how possible problems are to be solved. One question that is always in focus is if the competition between generators in the Nordic electricity market really works the way it was intended. Many argue that the concentration in ownership of generation plants already has gone too far. Together with joint ownership in nuclear facilities and barriers for entrance, critics say that this has resulted in higher electricity prices than necessary. In this report different methods to (ex ante) study potential possibilities for generating firms to influence the electricity price (market power) and (ex post) discover possible manipulation through analysing the spot price and other observed factors on the electricity market are analysed. The purpose of the longer underlying paper is to give a comprehensive treatment of the electricity market with storage, i.e. hydro power, with an auction market organisation and to test the models on the Nordic market in order to explore the explanatory power of auction market theory and the theory of contestable market. The main theoretical effort in the paper concerns auction theory with inventories. The paper develops an inter-temporal auction model of a thermal-hydro power market. Parallel to the derivation of the basic equations a numerical model is developed in order to illustrate the results of the model. Section 2 of the present paper summarizes the basic equations (derived in the longer paper) for an inter-temporal auction thermal-hydro market. Section 3 contains the illustrations of solutions to equations for some stylized markets. In section 4 the auction model is tested on the Nordic market

  20. Systemic granuloma observed in Atlantic salmon Salmo salar raised to market size in a freshwater recirculation aquaculture system

    Science.gov (United States)

    Systemic granuloma was observed in sampled adult Atlantic salmon Salmo salar raised to harvest size in a freshwater recirculation aquaculture system. The prevalence of this condition was estimated at 10-20% of the population, with affected individuals grossly demonstrating pathology in varying degre...

  1. Post-marketing safety and effectiveness evaluation of the intravenous anti-influenza neuraminidase inhibitor peramivir (I): a drug use investigation.

    Science.gov (United States)

    Komeda, Takuji; Ishii, Shingo; Itoh, Yumiko; Ariyasu, Yasuyuki; Sanekata, Masaki; Yoshikawa, Takayoshi; Shimada, Jingoro

    2014-11-01

    Peramivir is the only intravenous formulation among anti-influenza neuraminidase inhibitors currently available. Peramivir was approved for manufacturing and marketing in Japan in January 2010. We conducted a drug use investigation of peramivir from October 2010 to February 2012 and evaluated its safety and effectiveness under routine clinical settings. We collected data of 1309 patients from 189 facilities across Japan and examined safety in 1174 patients and effectiveness in 1158 patients. In total, 143 adverse events were observed with an incidence rate of 7.33% (86/1174). Of these, 78 events were adverse drug reactions (ADRs) with an incidence rate of 4.34% (51/1174). The most frequently reported ADRs were diarrhea, vomiting, and nausea, with incidence rates of 1.87% (22/1174), 0.85% (10/1174), and 0.68% (8/1174), respectively. Moreover, no ADR was reported as serious. ADR onset was within 3 days after the start of peramivir administration in 91.0% (71 events) of the 78 ADRs, and ADRs were resolved or improved within 7 days after onset in 96.2% (75 events) of the 78 ADRs. Neither patient characteristics nor treatment factors appeared to significantly affect drug safety. With regard to effectiveness, the median time to alleviation of both influenza symptoms and fever was 3 days, including the first day of administration. The present study demonstrates the safety and effectiveness of peramivir under routine clinical settings. Copyright © 2014 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  2. Significant Variation of Post-critical SsPmp Amplitude as a Result of Variation in Near-surface Velocity: Observations from the Yellowknife Array

    Science.gov (United States)

    Ferragut, G.; Liu, T.; Klemperer, S. L.

    2017-12-01

    In recent years Virtual Deep Seismic Sounding (VDSS) emerged as a novel method to image the Moho, which uses the post-critical reflection P waves at the Moho generated by teleseismic S waves at the free surface near the receivers (SsPmp). However, observed SsPmp sometimes have significantly lower amplitude than predicted, raising doubts among the seismic community on the theoretical basis of the method. With over two decades of continuous digital broadband records and major subduction zones in the range of 30-50 degrees, the Yellowknife Array in northern Canada provides a rich opportunity for observation of post-critical SsPmp. We analyze S wave coda of events with epicenter distances of 30-50°, and pay special attention to earthquakes in a narrow azimuth range that ­­­encompasses the Kamchatka Peninsula. Among 21 events with strong direct S energy on the radial components, we observe significant variation of SsPmp energy. After associating the SsPmp energy with the virtual source location of each event, we observe a general trend of decreasing SsPmp energy from NE to SW. As the trend coincides with the transition from exposed basement of the Slave Craton to Paleozoic platform covered by Phanerozoic sediment, we interpret the decreasing SsPmp energy as a result of lower S velocity at the virtual sources, which reduces S-to-P reflection coefficients. We plan to include more events from the Aleutian Islands, the virtual sources of which are primarily located in the Paleozoic platform. This will allow us to further investigate the relationship between SsPmp amplitude and near-surface velocity.

  3. Observations and models of Co- and Post-Seismic Deformation Due to the 2015 Mw 7.8 Gorkha (Nepal) Earthquake

    Science.gov (United States)

    Wang, K.; Fialko, Y. A.

    2016-12-01

    The 2015 Mw 7.8 Gorkha (Nepal) earthquake occurred along the central Himalayan arc, a convergent boundary between India and Eurasian plates. We use space geodetic data to investigate co- and post-seismic deformation due to the Gorkha earthquake. Because the epicentral area of the earthquake is characterized by strong variations in surface relief and material properties, we developed finite element models that explicitly account for topography and 3-D elastic structure. Compared with slip models obtained using homogenous elastic half-space models, the model including elastic heterogeneity and topography exhibits greater (up to 10%) slip amplitude. GPS observations spanning more than 1 year following the earthquake show overall southward movement and uplift after the Gorkha earthquake, qualitatively similar to the coseismic deformation pattern. Kinematic inversions of GPS data, and forward modeling of stress-driven creep indicate that the observed post-seismic transient is consistent with afterslip on a down-dip extention of the seismic rupture. The Main Himalayan Thrust (MHT) has negligible creep updip of the 2015 rupture, reiterating a future seismic hazard. A poro-elastic rebound may contribute to the observed uplift southward motion, but the predicted surface displacements are small (on the order of 1 cm or less). We also tested a wide range of visco-elastic relaxation models, including 1-D and 3-D variations in the viscosity structure. All tested visco-elastic models predict the opposite signs of horizontal and vertical displacements compared to those observed. Available surface deformation data allow one to rule out a model of a low viscosity channel beneath Tibetan Plateau invoked to explain variations in surface relief at the plateau margins.

  4. A review and additional post-hoc analyses of the incidence and impact of constipation observed in darifenacin clinical trials

    Directory of Open Access Journals (Sweden)

    Tack J

    2012-09-01

    Full Text Available Jan Tack,1 Jean-Jacques Wyndaele,2 Greg Ligozio,3 Mathias Egermark41University of Leuven, Gastroenterology Section, Leuven, 2University of Antwerp, Department of Urology, Antwerp, Belgium; 3Novartis Pharmaceuticals Corporation, NJ, USA; 4Roche Diagnostics Scandinavia AB, Bromma, Sweden and formerly of Novartis Pharma AG, Basel, SwitzerlandBackground: Constipation is a common side effect of antimuscarinic treatment for overactive bladder (OAB. This review evaluates the incidence and impact of constipation on the lives of patients with OAB being treated with darifenacin.Methods: Constipation data from published Phase III and Phase IIIb/IV darifenacin studies were reviewed and analyzed. Over 4000 patients with OAB (aged 18–89 years; ≥80% female enrolled in nine studies (three Phase III [data from these fixed-dose studies were pooled and provide the primary focus for this review], three Phase IIIb, and three Phase IV. The impact of constipation was assessed by discontinuations, use of concomitant laxatives, patient-reported perception of treatment, and a bowel habit questionnaire.Results: In the pooled Phase III trials, 14.8% (50/337 of patients on darifenacin 7.5 mg/day and 21.3% (71/334 on 15 mg/day experienced constipation compared with 12.6% (28/223 and 6.2% (24/388 with tolterodine and placebo, respectively. In addition, a few patients discontinued treatment due to constipation (0.6% [2/337], 1.2% [4/334], 1.8% [4/223], and 0.3% [1/388] in the darifenacin 7.5 mg/day or 15 mg/day, tolterodine, and placebo groups, respectively, or required concomitant laxatives (3.3% [11/337], 6.6% [22/334], 7.2% [16/223], and 1.5% [6/388] in the darifenacin 7.5 mg/day or 15 mg/day, tolterodine, and placebo groups, respectively. Patient-reported perception of treatment quality was observed to be similar between patients who experienced constipation and those who did not. During the long-term extension study, a bowel habit questionnaire showed only small

  5. Marketing the Library.

    Science.gov (United States)

    Dragon, Andrea C.

    1979-01-01

    Describes the positive action using marketing strategies that libraries must take to capture their share of the post-Proposition 13 tax dollar. Strategies discussed relate to price, product, promotion, and place. (JD)

  6. High-resolution observations of IRAS 08544-4431. Detection of a disk orbiting a post-AGB star and of a slow disk wind

    Science.gov (United States)

    Bujarrabal, V.; Castro-Carrizo, A.; Winckel, H. Van; Alcolea, J.; Contreras, C. Sánchez; Santander-García, M.; Hillen, M.

    2018-06-01

    Context. Aims: In order to study the effects of rotating disks in the post-asymptotic giant branch (post-AGB) evolution, we observe a class of binary post-AGB stars that seem to be systematically surrounded by equatorial disks and slow outflows. Although the rotating dynamics had only been well identified in three cases, the study of such structures is thought to be fundamental to the understanding of the formation of disks in various phases of the late evolution of binary stars and the ejection of planetary nebulae from evolved stars. Methods: We present ALMA maps of 12CO and 13CO J = 3-2 lines in the source IRAS 08544-4431, which belongs to the above mentioned class of objects. We analyzed the data by means of nebula models, which account for the expectedly composite source and can reproduce the data. From our modeling, we estimated the main nebula parameters, including the structure and dynamics and the density and temperature distributions. We discuss the uncertainties of the derived values and, in particular, their dependence on the distance. Results: Our observations reveal the presence of an equatorial disk in rotation; a low-velocity outflow is also found, probably formed of gas expelled from the disk. The main characteristics of our observations and modeling of IRAS 08544-4431 are similar to those of better studied objects, confirming our interpretation. The disk rotation indicates a total central mass of about 1.8 M⊙, for a distance of 1100 pc. The disk is found to be relatively extended and has a typical diameter of 4 × 1016 cm. The total nebular mass is 2 × 10-2 M⊙, of which 90% corresponds to the disk. Assuming that the outflow is due to mass loss from the disk, we derive a disk lifetime of 10 000 yr. The disk angular momentum is found to be comparable to that of the binary system at present. Assuming that the disk angular momentum was transferred from the binary system, as expected, the high values of the disk angular momentum in this and other

  7. Smallholder Information Sources and Communication Pathways for Cashew Production and Marketing in Tanzania: An Ex-Post Study in Tandahimba and Lindi Rural Districts, Southern Tanzania

    Science.gov (United States)

    Nyambo, Brigitte; Ligate, Elly

    2013-01-01

    Purpose: To identify and review production and marketing information sources and flows for smallholder cashew (Anacardium occidentale L.) growers in Tanzania and recommend systems improvements for better technology uptake. Design/methodology/approach: Two-stage purposive samples were drawn. First, two districts in the main cashew producing areas,…

  8. Action observation training of community ambulation for improving walking ability of patients with post-stroke hemiparesis: a randomized controlled pilot trial.

    Science.gov (United States)

    Park, Hyun-Ju; Oh, Duck-Won; Choi, Jong-Duk; Kim, Jong-Man; Kim, Suhn-Yeop; Cha, Yong-Jun; Jeon, Su-Jin

    2017-08-01

    To investigate the effects of action observation training involving community-based ambulation for improving walking ability after stroke. Randomized, controlled pilot study. Inpatient rehabilitation hospital. A total of 25 inpatients with post-stroke hemiparesis were randomly assigned to either the experimental group ( n = 12) or control group ( n = 13). Subjects of the experimental group watched video clips demonstrating four-staged ambulation training with a more complex environment factor for 30 minutes, three times a week for four weeks. Meanwhile, subjects of the control group watched video clips, which showed different landscape pictures. Walking function was evaluated before and after the four-week intervention using a 10-m walk test, community walk test, activities-specific balance confidence scale, and spatiotemporal gait measures. Changes in the values for the 10-m walk test (0.17 ±0.19 m/s vs. 0.05 ±0.08 m/s), community walk test (-151.42 ±123.82 seconds vs. 67.08 ±176.77 seconds), and activities-specific balance confidence (6.25 ±5.61 scores vs. 0.72 ±2.24 scores) and the spatiotemporal parameters (i.e. stride length (19.00 ±11.34 cm vs. 3.16 ±11.20 cm), single support (5.87 ±5.13% vs. 0.25 ±5.95%), and velocity (15.66 ±12.34 cm/s vs. 2.96 ±10.54 cm/s)) indicated a significant improvement in the experimental group compared with the control group. In the experimental group, walking function and ambulation confidence was significantly different between the pre- and post-intervention, whereas the control group showed a significant difference only in the 10-m walk test. Action observation training of community ambulation may be favorably used for improving walking function of patients with post-stroke hemiparesis.

  9. A multi-centre, prospective, clinical in-market evaluation to assess the performance of Opsite™ Post-Op Visible dressings.

    LENUS (Irish Health Repository)

    O'Brien, Gillian

    2010-10-01

    The aim of this study was to assess the performance of Opsite™ Post-Op Visible as a post-surgical dressing in a typical clinical setting. In this multi-centre clinical evaluation, patients who underwent clean surgery were treated with Opsite Post-Op Visible dressing. Duration of dressing wear, visibility through the dressing and ability to handle exudate were assessed and the product was rated in comparison with those normally used. A total of 64 patients were recruited. Mean wear time was 4·5 days. Exudate management was rated very good or good at 96% of assessments. Visibility of the incision site was rated as very good or good at 72%, and as acceptable at 24%, of assessments. Patient comfort was rated very comfortable (63%) or comfortable (37%) at all assessments. Dressings were generally rated as satisfactory or exceeding expectations with clinicians stating that the Opsite Post-Op Visible dressing was better than the dressing they routinely used for 92% of patients. Opsite Post-Op Visible dressing is an innovative dressing combining good visibility with exudate management and patient comfort. It was found to have adequate wear time, visibility and exudate management properties making it suitable for use on a variety of surgical incision sites.

  10. The quest for stable circumbinary companions to post-common envelope sdB eclipsing binaries. Does the observational evidence support their existence?

    Science.gov (United States)

    Pulley, D.; Faillace, G.; Smith, D.; Watkins, A.; von Harrach, S.

    2018-03-01

    Context. Period variations have been detected in a number of eclipsing close compact binary subdwarf B stars (sdBs) and these have often been interpreted as being caused by circumbinary massive planets or brown dwarfs. According to canonical binary models, the majority of sdB systems are produced from low mass stars with degenerate cores where helium is ignited in flashes. Various evolutionary scenarios have been proposed for these stars, but a definite mechanism remains to be established. Equally puzzling is the formation of these putative circumbinary objects which must have formed from the remaining post-common envelope circumbinary disk or survived its evolution. Aim. In this paper we review the eclipse time variations (ETVs) exhibited by seven such systems (EC 10246-2707, HS 0705+6700, HS 2231+2441, J08205+0008, NSVS 07826147, NSVS 14256825, and NY Vir) and explore whether there is conclusive evidence that the ETVs observed over the last two decades can reliably predict the presence of one or more circumbinary bodies. Methods: We report 246 new observations of the seven sdB systems made between 2013 September and 2017 July using a worldwide network of telescopes. We combined our new data with previously published measurements to analyse the ETVs of these systems. Results: Our data show that period variations cannot be modelled simply on the basis of circumbinary objects. This implies that more complex processes may be taking place in these systems. These difficulties are compounded by the secondary star not being spectroscopically visible. From ETVs, it has historically been suggested that five of the seven binary systems reported here had circumbinary objects. Based on our recent observations and analysis, only three systems remain serious contenders. We find agreement with other observers that at least a decade of observations is required to establish reliable ephemerides. With longer observational baselines it is quite conceivable that the data will support

  11. Observations of Red-headed Falcon Falco chicquera (Aves: Falconiformes: Falconidae nest at Keraniganj, Dhaka, Bangladesh, with a focus on post-fledging behavior

    Directory of Open Access Journals (Sweden)

    Mohammod Foysal

    2015-04-01

    Full Text Available A nest of Red-headed Falcon Falco chicquera was observed in 2009, beginning with the onset of breeding and continuing on to the next breeding of the pair.  The nest was found on 02 March 2009 in an electricity pylon in a sub-urban area at Keraniganj, Dhaka, Bangladesh.  The incubation period was estimated at a minimum of four weeks and the nestling period was 37 days.  Fledglings remained in the nesting area up to four months after fledging.  The female almost exclusively fed the nestlings and fledglings.  The diet of adults, nestlings and fledglings consisted of 72% small birds (sparrow sized and 28% Pipistrellus bats (n = 112.  The diet of fledglings consisted of 61% birds and 39% bats (n= 72; before independence mainly birds and after independence mainly bats.  Parents delivered prey to fledglings up to 39 days after fledging (i.e., post-fledging dependence period was 39 days.  The fledgling’s flight pattern was distinguishable from the adults nearly two months after fledging.  The fledgling’s call reminiscent of a begging call was recorded up to 75 days after fledging. Food competition was observed among the fledglings; when one of the fledglings snatched prey from a parent, the other siblings tried to pilfer it.  The parents had resumed breeding eight months after the fledging stage of their offspring. 

  12. Using the market to regulate health care price: why heart hospitals will have a competitive advantage in the world of post-diagnostic related group pricing.

    Science.gov (United States)

    McLean, Thomas R

    2004-01-01

    For the past 20 years, the federal government has reimbursed hospital services by administrating pricing. Simply put, under such a system the government dictated the prices of medical services. Not only has administrative pricing failed to control medical inflation, but such failure could have been predicted from a review of basic economics. Accordingly, to eliminate the deleterious effects of administrative pricing, it is not surprising that the government is gathering information on hospital quality and cost in anticipation of a return to a system in which the price for hospital services is determined by the market. For some hospitals, this will be good news because they will be able to negotiate a more favorable rate of reimbursement. Unfortunately, for some hospitals a market system will be bad news because the government is not going to negotiate a provider contract with every hospital. In short, when the government returns to a market system for pricing of hospital services, competition among hospitals is going to become even more competitive.

  13. A long-term soil structure observatory for post-compaction soil structure evolution: design and initial soil structure recovery observations

    Science.gov (United States)

    Keller, Thomas; Colombi, Tino; Ruiz, Siul; Grahm, Lina; Reiser, René; Rek, Jan; Oberholzer, Hans-Rudolf; Schymanski, Stanislaus; Walter, Achim; Or, Dani

    2016-04-01

    Soil compaction due to agricultural vehicular traffic alters the geometrical arrangement of soil constituents, thereby modifying mechanical properties and pore spaces that affect a range of soil hydro-ecological functions. The ecological and economic costs of soil compaction are dependent on the immediate impact on soil functions during the compaction event, and a function of the recovery time. In contrast to a wealth of soil compaction information, mechanisms and rates of soil structure recovery remain largely unknown. A long-term (>10-yr) soil structure observatory (SSO) was established in 2014 on a loamy soil in Zurich, Switzerland, to quantify rates and mechanisms of structure recovery of compacted arable soil under different post-compaction management treatments. We implemented three initial compaction treatments (using a two-axle agricultural vehicle with 8 Mg wheel load): compaction of the entire plot area (i.e. track-by-track), compaction in wheel tracks, and no compaction. After compaction, we implemented four post-compaction soil management systems: bare soil (BS), permanent grass (PG), crop rotation without mechanical loosening (NT), and crop rotation under conventional tillage (CT). BS and PG provide insights into uninterrupted natural processes of soil structure regeneration under reduced (BS) and normal biological activity (PG). The two cropping systems (NT and CT) enable insights into soil structure recovery under common agricultural practices with minimal (NT) and conventional mechanical soil disturbance (CT). Observations include periodic sampling and measurements of soil physical properties, earthworm abundance, crop measures, electrical resistivity and ground penetrating radar imaging, and continuous monitoring of state variables - soil moisture, temperature, CO2 and O2 concentrations, redox potential and oxygen diffusion rates - for which a network of sensors was installed at various depths (0-1 m). Initial compaction increased soil bulk density

  14. Safety of lornoxicam in the treatment of postoperative pain: a post-marketing study of analgesic regimens containing lornoxicam compared with standard analgesic treatment in 3752 day-case surgery patients.

    Science.gov (United States)

    Rawal, Narinder; Krøner, Karsten; Simin-Geertsen, Marija; Hejl, Charlotte; Likar, Rudolf

    2010-01-01

    Post-marketing surveillance studies can provide supplemental data on the safety of medications in the general population. This study aimed to evaluate the safety of analgesic regimens including the NSAID lornoxicam in the short-term treatment of postoperative pain in a clinically relevant population. Randomized, open-label, multicentre, multinational, observational cohort study of 4 days' duration. In-hospital postoperative setting, with discharge to home treatment within 24 hours of surgery. Adults aged > or =18 years expected to be in need of analgesic treatment after day-case surgery. Analgesic regimens containing lornoxicam were compared with a standard analgesic treatment, which was defined as the treatment that the patient would normally receive at the centre. Following day-case surgery, patients were provided with appropriate analgesic medication, and adverse events (AEs; defined as all recorded events with symptoms) were recorded by the investigator during the in-hospital stay and by the patient for the next 3 days using entries recorded morning and evening in a patient diary. Statistical analyses tested for between-treatment differences in AEs, adverse drug reactions (ADRs; defined as events probably, possibly or unlikely to be related to treatment) and gastrointestinal AEs (GI-AEs). A total of 4152 patients were randomized to treatment. Since 400 patients did not take any analgesic, the safety population consisted of 1838 patients for lornoxicam and 1914 patients for standard analgesic treatment. Demographic and disease characteristics were similar between the two treatment groups, as were the type of surgery and the anaesthesia used in surgery. In the safety population, 16.9% of patients received no analgesic in hospital, and when analgesics were provided they were often administered in combination. Similarly, approximately 17% of patients did not take any analgesics at home. AEs were reported in 27.1% and 29.4% of patients in the lornoxicam and standard

  15. The effects of transdermal rotigotine on non-motor symptoms of Parkinson's disease: a multicentre, observational, retrospective, post-marketing study.

    Science.gov (United States)

    Valldeoriola, Francesc; Salvador, Antonio; Gómez-Arguelles, José Maria; Marey, José; Moya, Miguel; Ayuga, Ángel; Ramírez, Francisco

    2018-04-01

    This study evaluated the effect of ≥6 months of transdermal rotigotine on non-motor and motor symptoms of patients with advanced Parkinson's disease. The study was conducted in Spain between September 2011 and December 2012 (ClinicalTrials.gov: NCT01504529). The primary efficacy variable was the change from baseline in non-motor symptoms, as assessed by changes in Parkinson's Disease Non-Motor Symptoms Questionnaire total scores at 6 months. Secondary endpoints included the assessment of motor symptoms by Unified Parkinson's Disease Rating Scale III scores. Data from 378 patients (mean age: 70.2 years; 56.9% male) with Parkinson's disease receiving rotigotine from were collected. Mean disease duration was 6.1 years, and mean rotigotine treatment duration was 45.6 months. Rotigotine reduced non-motor symptoms by 14.6% (mean change from baseline in Parkinson's Disease Non-Motor Symptoms Questionnaire: -1.5 ± 3.4; p < 0.0001). The majority of patients (58.2%) had improved non-motor symptoms at 6 months. Comparing the baseline versus study end, fewer patients experienced events in the urinary (78.6% vs. 73.3%; p = 0.0066), sleep (82.8% vs. 72.8%; p < 0.0001) and mood/cognition (77.3% vs. 66.4%; p < 0.0001) domains of the Parkinson's Disease Non-Motor Symptoms Questionnaire. Mean motor symptoms were reduced from baseline by 8.0% (mean change from baseline in Unified Parkinson's Disease Rating Scale III: -2.6 ± 8.0; p < 0.0001). In clinical practice in Spain, rotigotine may be an effective treatment to reduce the non-motor and motor symptoms in patients with advanced Parkinson's disease.

  16. Active learning at the post-secondary level to promote the development of leadership competency management in response to the labor market requirements of Puerto Rico

    Directory of Open Access Journals (Sweden)

    Angel L. Rivera Aponte

    2010-09-01

    Full Text Available Active learning at undergraduate level is necessary to promote business competencies on behalf of the actual labor market in Puerto Rico.The participation of students registered in the Leadership course at the School of Business, using the induction process, generates throughout the integration of theory and practice the encouragement of competencies development. Qualitative analysis demostrates the effectiveness of the teaching and learning experience through pedagogical methodologies of active learning. Results obtained by students’ success during the teaching and learning experience increased the competencies level of leadership, etc.

  17. MARKETING CHARACTERISTICS OF INSURANCE MARKET IN UKRAINE

    Directory of Open Access Journals (Sweden)

    А. Sabirova

    2014-03-01

    Full Text Available The current state of the insurance market of Ukraine in the post-crisis period, by comparison with the pre-crisis was investigated in the paper. The insurance market in the pre-crisis period grew rapidly, but was unable to withstand the economic crisis and suffered a crushing blow. The economic crisis of 2008-2009 led to a decrease of the demand for financial services in general and insurance services in particular. The lack of development of the insurance market created high barriers for responding and adapting to changes that occurred during the crisis.

  18. A black market for upvotes and likes

    OpenAIRE

    Héder, Mihály

    2018-01-01

    Purpose: This research investigates controversial online marketing techniques that involve buying hundreds or even thousands of upvotes, likes, comments, etc. Methodology: Observation and categorization of 7,426 campaigns posted on the crowdsourcing platform microworkers.com over a 365 day (i.e., yearlong) period were conducted. Hypotheses about the mechanics and effectiveness of these campaigns were established and evaluated. Findings: The campaigns contained a combined 1,856,316 microtasks,...

  19. An observational pre-post study of re-structuring Medicine inpatient teaching service: Improved continuity of care within constraint of 2011 duty hours.

    Science.gov (United States)

    Cheung, Joseph Y; Mueller, Daniel; Blum, Marissa; Ravreby, Hannah; Williams, Paul; Moyer, Darilyn; Caroline, Malka; Zack, Chad; Fisher, Susan G; Feldman, Arthur M

    2015-09-01

    Implementation of more stringent regulations on duty hours and supervision by the Accreditation Council for Graduate Medical Education in July 2011 makes it challenging to design inpatient Medicine teaching service that complies with the duty hour restrictions while optimizing continuity of patient care. To prospectively compare two inpatient Medicine teaching service structures with respect to residents' impression of continuity of patient care (primary outcome), time available for teaching, resident satisfaction and length-of-stay (secondary endpoints). Observational pre-post study. Surveys were conducted both before and after Conventional Medicine teaching service was changed to a novel model (MegaTeam). Academic General Medicine inpatient teaching service. Surveys before and after MegaTeam implementation were completed by 68.5% and 72.2% of internal medicine residents, respectively. Comparing conventional with MegaTeam, the % of residents who agreed or strongly agreed that the (i) ability to care for majority of patients from admission to discharge increased from 29.7% to 86.6% (pcare, decreases number of handoffs, provides adequate supervision and teaching of interns and medical students, increases resident overall satisfaction and decreases length-of-stay. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Are Vietnam and Chinese stock markets out of the US contagion effect in extreme events?

    Science.gov (United States)

    Nguyen, Cuong; Ishaq Bhatti, M.; Henry, Darren

    2017-08-01

    This paper employs Chi-plots, Kendall (K)-plots and three different copula functions to empirically examine the tail dependence between the US stock market and stock markets in Vietnam and China in order to test contagion effects pre- and post- the US subprime mortgage crisis. The results based on data between 2003 and 2011 indicate the presence of left tail dependence before and after the crisis suggesting no change in dependence structure, but there exists stronger left tail dependence between the US and Vietnam stock markets. It is observed that the US and Vietnam stock markets are more prone to crashing than booming together. For the Chinese market, the US and Shanghai stock markets exhibit left tail dependence before the crisis, but no evidence of post-crisis tail dependency. On the contrary, the Shenzhen stock market is independent of the US market before and after the crisis which implies that an extreme event in the US market is less likely to influence the Shenzhen stock market. This suggests that there is significant potential for risk diversification by investing in the Shenzhen market by US investors after the financial crisis. These results have not been documented in the existing literature and provide a new insight into risk diversification between the two important Asian emerging stock markets.

  1. Effects of spine loading in a patient with post-decompression lumbar disc herniation: observations using an open weight-bearing MRI.

    Science.gov (United States)

    Mahato, Niladri Kumar; Sybert, Daryl; Law, Tim; Clark, Brian

    2017-05-01

    Our objective was to use an open weight-bearing MRI to identify the effects of different loading conditions on the inter-vertebral anatomy of the lumbar spine in a post-discectomy recurrent lumbar disc herniation patient. A 43-year-old male with a left-sided L5-S1 post-decompression re-herniation underwent MR imaging in three spine-loading conditions: (1) supine, (2) weight-bearing on standing (WB), and (3) WB with 10 % of body mass axial loading (WB + AL) (5 % through each shoulder). A segmentation-based proprietary software was used to calculate and compare linear dimensions, angles and cross sections across the lumbar spine. The L5 vertebrae showed a 4.6 mm posterior shift at L5-S1 in the supine position that changed to an anterior translation >2.0 mm on WB. The spinal canal sagittal thickness at L5-S1 reduced from supine to WB and WB + AL (13.4, 10.6, 9.5 mm) with corresponding increases of 2.4 and 3.5 mm in the L5-S1 disc protrusion with WB and WB + AL, respectively. Change from supine to WB and WB + AL altered the L5-S1 disc heights (10.2, 8.6, 7.0 mm), left L5-S1 foramen heights (12.9, 11.8, 10.9 mm), L5-S1 segmental angles (10.3°, 2.8°, 4.3°), sacral angles (38.5°, 38.3°, 40.3°), L1-L3-L5 angles (161.4°, 157.1°, 155.1°), and the dural sac cross sectional areas (149, 130, 131 mm 2 ). Notably, the adjacent L4-L5 segment demonstrated a retro-listhesis >2.3 mm on WB. We observed that with weight-bearing, measurements indicative of spinal canal narrowing could be detected. These findings suggest that further research is warranted to determine the potential utility of weight-bearing MRI in clinical decision-making.

  2. Coordinated ground-based, low altitude satellite and Cluster observations on global and local scales during a transient post-noon sector excursion of the magnetospheric cusp

    Directory of Open Access Journals (Sweden)

    H. J. Opgenoorth

    Full Text Available On 14 January 2001, the four Cluster spacecraft passed through the northern magnetospheric mantle in close conjunction to the EISCAT Svalbard Radar (ESR and approached the post-noon dayside magnetopause over Green-land between 13:00 and 14:00 UT. During that interval, a sudden reorganisation of the high-latitude dayside convection pattern occurred after 13:20 UT, most likely caused by a direction change of the Solar wind magnetic field. The result was an eastward and poleward directed flow-channel, as monitored by the SuperDARN radar network and also by arrays of ground-based magnetometers in Canada, Greenland and Scandinavia. After an initial eastward and later poleward expansion of the flow-channel between 13:20 and 13:40 UT, the four Cluster spacecraft, and the field line footprints covered by the eastward looking scan cycle of the Söndre Strömfjord incoherent scatter radar were engulfed by cusp-like precipitation with transient magnetic and electric field signatures. In addition, the EISCAT Svalbard Radar detected strong transient effects of the convection reorganisation, a poleward moving precipitation, and a fast ion flow-channel in association with the auroral structures that suddenly formed to the west and north of the radar. From a detailed analysis of the coordinated Cluster and ground-based data, it was found that this extraordinary transient convection pattern, indeed, had moved the cusp precipitation from its former pre-noon position into the late post-noon sector, allowing for the first and quite unexpected encounter of the cusp by the Cluster spacecraft. Our findings illustrate the large amplitude of cusp dynamics even in response to moderate solar wind forcing. The global ground-based data proves to be an invaluable tool to monitor the dynamics and width of the affected magnetospheric regions.

    Key words. Magnetospheric cusp, ionosphere, reconnection, convection flow-channel, Cluster, ground-based observations

  3. Marketing; Il marketing

    Energy Technology Data Exchange (ETDEWEB)

    Muscigna, M [ENEA, Centro Ricerche Casaccia, S. Maria di Galeria, RM (Italy). Dipt. Innovazione

    1999-07-01

    The report discusses marketing strategies oriented to the organizations and analyzes its critical factors, which determine the success of the organization activity. [Italian] Il rapporto analizza i caratteri delle strategie del marketing orientato all'impresa. Vengono infine analizzati i fattori critici che determinano il successo o l'insuccesso delle scelte aziendali.

  4. Marketing; Il marketing

    Energy Technology Data Exchange (ETDEWEB)

    Muscigna, M. [ENEA, Centro Ricerche Casaccia, S. Maria di Galeria, RM (Italy). Dipt. Innovazione

    1999-07-01

    The report discusses marketing strategies oriented to the organizations and analyzes its critical factors, which determine the success of the organization activity. [Italian] Il rapporto analizza i caratteri delle strategie del marketing orientato all'impresa. Vengono infine analizzati i fattori critici che determinano il successo o l'insuccesso delle scelte aziendali.

  5. Impact of Chronic Renal Failure on Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Artery Disease: Subgroup Analysis from Zilver PTX Post-Market Surveillance Study in Japan.

    Science.gov (United States)

    Ogawa, Yukihisa; Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Saunders, Alan T; Dake, Michael D

    2017-11-01

    Favorable long-term outcomes of the Zilver PTX drug-eluting stent (DES) in femoropopliteal lesions have been demonstrated. Chronic renal failure (CRF) has been shown to be a risk factor for restenosis and decreased limb salvage. The results of the DES in patients with CRF have not previously been reported. This study compares the results with the DES in patients with CRF and those without CRF. This retrospective analysis from the Zilver PTX Japan Post-Market Surveillance Study included 321 patients with CRF and 584 patients without CRF. Outcomes included freedom from target lesion revascularization (TLR) and patency. Of the patients included in this subgroup analysis, 2-year data were available for 209 patients in the CRF group and 453 patients in the non-CRF group. The two groups were similar in terms of lesion length and the frequency of in-stent restenosis. Critical limb ischemia, severe calcification, and diabetes were more common in patients with CRF, whereas total occlusion was more common in patients without CRF. Freedom from TLR rates were 81.4 versus 84.9% (p = 0.24), and patency rates were 70.7 versus 70.3% (p = 0.95) in patients with and without CRF at 2 years, respectively. This is the first comparative study of the DES in femoropopliteal artery lesions in patients with and without CRF. These results indicate that the DES placed in femoropopliteal artery lesions of CRF patients is safe and effective with similar patency and TLR rates to patients without CRF. Level 3, Post-Market Surveillance Study.

  6. Livestock Marketing.

    Science.gov (United States)

    Futrell, Gene; And Others

    This marketing unit focuses on the seasonal and cyclical patterns of livestock markets. Cash marketing, forward contracting, hedging in the futures markets, and the options markets are examined. Examples illustrate how each marketing tool may be useful in gaining a profit on livestock and cutting risk exposure. The unit is organized in the…

  7. Analysis of impact of Internet marketing on visits of the Lenovo Blog CZ

    OpenAIRE

    Ruskovská, Petra

    2013-01-01

    The thesis analyses the impact of Internet marketing tools on visits of the Lenovo Blog CZ, the official blog of the computer manufacturer Lenovo. It focuses evolution of visits of the blog over time, on the impact of social networks and Facebook posts paid promotion on visits. Finally, it observes to what extent the Internet marketing tools impact overall visits of the blog over the observed time.

  8. [Drug registries: post-marketing evaluation of the benefit-risk profile and promotion of appropriateness. The regional point of view].

    Science.gov (United States)

    Martelli, Luisa; Venegoni, Mauro

    2013-06-01

    Italian Regions and the Italian regulatory agency share a common interest in promoting the appropriateness of drug use, containing drug expenditure and acquiring additional evidence on the effectiveness and safety of drugs. Drug registries can help attaining these objectives. Specifically, the registries implemented in Italy were able to cover the first two objectives, whereas some critical issues were raised on the third one. For instance, the data recorded in the registries are not available at regional level to conduct safety and effectiveness investigations. This is a paradox, when considering that drugs included in the registries have a risk-benefit profile that is only partially defined at the moment of marketing. Currently, researchers and regions can conduct epidemiological research (cohort and case control studies), on the basis of record-linkage procedures, on all drugs prescribed in general practice (which are older drugs with a better defined risk-benefit profile). The expected outcomes of registries should be more clearly defined: when the main aim is to promote appropriateness, the recording of only a very limited amount of data should be required (to avoid a bureaucratic burden on clinicians).The Italian centers of the ENCePP network might play an important role in planning and conducting drug registries: through the presence in the steering committees of the registries, and in conducting epidemiological studies that make the most of this powerful instrument.

  9. Spatial analysis of private tanker water markets in Jordan: Using a hydroeconomic multi-agent model to simulate non-observed water transfers

    Science.gov (United States)

    Klassert, Christian; Yoon, Jim; Gawel, Erik; Sigel, Katja; Klauer, Bernd; Talozi, Samer; Lachaut, Thibaut; Selby, Philip; Knox, Stephen; Gorelick, Steven; Tilmant, Amaury; Harou, Julien; Mustafa, Daanish; Medellin-Azuara, Josue; Rajsekhar, Deepthi; Avisse, Nicolas; Zhang, Hua

    2017-04-01

    The country of Jordan is characterized by severe water scarcity and deficient public water supply networks. To address these issues, Jordan's water sector authorities have adopted a water rationing scheme implemented by interrupting piped water supply for several days per week. As in many arid countries around the world, this has led to the emergence of private markets of small-scale providers, delivering water via tanker trucks. On the one hand, these markets play a crucial role in meeting residential and commercial water demands by balancing the shortcomings of the public supply system. On the other hand, providers partially rely on illegal abstractions from rural ground and surface water sources, thereby circumventing regulatory efforts to conserve these resources. Private tanker water markets, therefore, provide a substantial contribution to consumer welfare while jeopardizing freshwater resource sustainability. Thus, a better understanding of these markets is of great importance for the formulation of policy interventions pursuing freshwater sustainability in a socially acceptable manner. Direct assessments of the size of these markets or their responses to policy interventions are, however, impeded by their partially illegal nature and the resulting lack of available information. To overcome this data collection challenge, we use a hydroeconomic multi-agent model developed in the Jordan Water Project to indirectly simulate country-wide tanker water market activities on the basis of demand and supply estimates. The demand for tanker water is conceptualized as a residual demand, remaining after a water user has depleted all available cheap and qualitatively reliable piped water. It is derived from residential and commercial demand functions on the basis of survey data. Tanker water supply is determined by farm simulation models calculating the groundwater pumping cost and the agricultural opportunity cost of tanker water. Finally, a spatial market algorithm

  10. Opportunities for market-based programs worldwide that reduce greenhouse gas emissions: Initial Observations from Missions to the Philippines, South Africa, and Mexico

    International Nuclear Information System (INIS)

    Stanton-Hoyle, D.R.

    1998-01-01

    Globally, governments and industries are implementing innovative voluntary programs to reduce greenhouse gas emissions. Often these programs encourage groups to use cost effective technologies that capture market-based forces. These programs are successful because they capitalize on existing opportunities where both the environment and the participants can benefit (i.e., win-win opportunities). This paper documents efforts to investigate these kinds of win-win opportunities in three developing countries: the Philippines, South Africa, and Mexico. Initial observations are provided as fresh information from the field, drawing on six missions during the last nine months. Utility costs, interest rates, and overall economic health appear to critically affect opportunities in each country. By contrast, details of heating, ventilating and air-conditioning (HVAC) design and local climate were often important differences between countries. These affect opportunities, for example, to achieve significant savings from cooling systems or not. Looking at the success of ESCOs was somewhat surprising. One might expect to see the most successful ESCO activity where utility costs are high and upgrade opportunities are plentiful (such as in the Philippines). This was not the case, however, as research in the Philippines did not reveal even one active ESCO contract yet. Design practices for new construction were in need of the same thing that helps US design teams do a better job of energy-efficient design, better communications between design team members. Finally, industrial firms were doing a variety of EE upgrades in each country, but this level of activity was relatively small compared to what should be cost effective

  11. Post-marketing experience with nevirapine extended release (XR) tablets: effectiveness and tolerability in a population-based cohort in British Columbia, Canada.

    Science.gov (United States)

    Lepik, Katherine J; Yip, Benita; McGovern, Rachel A; Ding, Erin; Nohpal, Adriana; Watson, Birgit E; Toy, Junine; Akagi, Linda; Harrigan, P Richard; Moore, David M; Hogg, Robert S; Montaner, Julio S G; Barrios, Rolando

    2015-01-01

    Nevirapine 400 mg extended release tablets (nevirapine-XR) are a once-daily alternative to nevirapine 200 mg immediate release tablets (nevirapine-IR). Study objectives were to describe the effectiveness and tolerability of nevirapine-XR in clinical practice and, for patients who switched from once daily 2×200 mg nevirapine-IR to nevirapine-XR, compare virological suppression and plasma nevirapine concentrations during each treatment period. HIV-1-infected adults entered the study cohort if they initiated nevirapine-XR in British Columbia (BC) Canada between 1 April 2012 and 30 September 2012 and were followed until 30 September 2013. Demographic and clinical variables were abstracted from the BC Centre for Excellence in HIV/AIDS databases. Patients who switched from once daily nevirapine-IR to nevirapine-XR were monitored for 6 months pre- and post-switch with comparison of virological suppression (McNeamer's test) and median random plasma nevirapine concentrations (Wilcoxon-Mann-Whitney test) in each period. The 536 nevirapine-XR-treated patients were 96% male, median (IQR) age 49.9 (44.0-56.9) years. Median follow-up was 15.6 (14.7-16.5) months, with 474/536 (88%) maintaining virological suppression. Emergent drug resistance developed in 5/536 (1%), adverse drug reactions in 17/536 (3%) and, although 31/536 (6%) reported 'whole' tablets in their stools, this was not associated with adverse outcomes. Among the 305 patients who switched from nevirapine-IR to nevirapine-XR, median (IQR) random plasma nevirapine concentration was higher during nevirapine-IR 5,000 (3,690-6,090) ng/ml than nevirapine-XR 3,930 (3,050-5,150) ng/ml (Pmarketing study affirms the effectiveness and tolerability of nevirapine-XR as an alternative to nevirapine-IR in adults.

  12. Market, Regulation, Market, Regulation

    DEFF Research Database (Denmark)

    Frankel, Christian; Galland, Jean-Pierre

    2015-01-01

    barriers to trade in Europe, realized the free movement of products by organizing progressively several orders of markets and regulation. Based on historical and institutional documents, on technical publications, and on interviews, this article relates how the European Commission and the Member States had......This paper focuses on the European Regulatory system which was settled both for opening the Single Market for products and ensuring the consumers' safety. It claims that the New Approach and Standardization, and the Global Approach to conformity assessment, which suppressed the last technical...... alternatively recourse to markets and to regulations, at the three main levels of the New Approach Directives implementation. The article focuses also more specifically on the Medical Devices sector, not only because this New Approach sector has long been controversial in Europe, and has recently been concerned...

  13. Safety and effectiveness of tadalafil in pediatric patients with pulmonary arterial hypertension: a sub-group analysis based on Japan post-marketing surveillance.

    Science.gov (United States)

    Yamazaki, Hiroyoshi; Kobayashi, Noriko; Taketsuna, Masanori; Tajima, Koyuki; Suzuki, Nahoko; Murakami, Masahiro

    2017-12-01

    To evaluate the long-term safety and effectiveness of tadalafil in pediatric patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. This is an observational surveillance of PAH patients receiving tadalafil in the contracted sites. A sub-group analysis was performed of 391 pediatric PAH patients (Effectiveness measurements included change in World Health Organization (WHO) functional classification of PAH, cardiac catheterization (pulmonary arterial pressure: PAP), and echocardiography (tricuspid regurgitation pressure gradient: TRPG). Survival rate was also measured. The mean patient age was 5.7 ± 5.34 years. Associated PAH (APAH) and idiopathic PAH (IPAH) accounted for 76.0% and 17.6%, respectively, of the PAH patients. Patients were followed for up to 2 years. Among 391 patients analyzed for safety, the overall incidence rate of ADRs was 16.6%. The common ADRs (≥ 1%) were headache (2.8%), hepatic function abnormal, platelet count decreased (1.3% each), and epistaxis, (1.0%). Eleven patients (2.8%) reported 16 SADRs. Three patients died secondary to SADRs. For the effectiveness analysis, the incidence of WHO functional class improvement at 3 months, 1 year, and 2 years after the initiation of tadalafil and last observation in pediatric patients were 16.5%, 19.7%, and 16.3%, respectively. Both PAP and TRPG showed a statistically significant reduction at last observation. This manuscript reveals the use of tadalafil in the real-world pediatric population with an acceptable safety profile in Japan.

  14. Changes in the in-hospital mortality and 30-day post-discharge mortality in acutely admitted older patients: retrospective observational study

    NARCIS (Netherlands)

    van Rijn, Marjon; Buurman, Bianca M.; MacNeil-Vroomen, Janet L.; Suijker, Jacqueline J.; ter Riet, Gerben; van Charante, Eric P. Moll; de Rooij, Sophia E.

    2016-01-01

    to compare changes over time in the in-hospital mortality and the mortality from discharge to 30 days post-discharge for six highly prevalent discharge diagnoses in acutely admitted older patients as well as to assess the effect of separately analysing the in-hospital mortality and the mortality

  15. Coordinated ground-based, low altitude satellite and Cluster observations on global and local scales during a transient post-noon sector excursion of the magnetospheric cusp

    DEFF Research Database (Denmark)

    Opgenoorth, H.J.; Lockwood, M.; Alcayde, D.

    2001-01-01

    On 14 January 2001, the four Cluster spacecraft passed through the northern magnetospheric mantle in close conjunction to the EISCAT Svalbard Radar (ESR) and approached the post-noon dayside magnetopause over Greenland between 13:00 and 14:00 UT During that interval, a sudden reorganisation of th...

  16. Pre- and post-diagnosis costs of tuberculosis to patients on Directly Observed Treatment Short course in districts of southwestern Ethiopia: a longitudinal study.

    Science.gov (United States)

    Asres, Abyot; Jerene, Degu; Deressa, Wakgari

    2018-05-21

    Financial burden on tuberculosis (TB) patients results in delayed treatment and poor compliance. We assessed pre- and post-diagnosis costs to TB patients. A longitudinal study among 735 new TB cases was conducted from January 2015 through June 2016 in 10 woredas (districts) of southwestern Ethiopia. Direct out-of-pocket, payments, and lost income (indirect cost) were solicited from patients during the first 2 months and at the end of treatment. Thus, we ascertained direct medical, nonmedical, and indirect costs incurred by patients during pre- and post-diagnosis periods. We categorized costs incurred from onset of illness until TB diagnosis as pre-diagnosis and that incurred after diagnosis through treatment completion as post-diagnosis. Pre- and post-diagnosis costs constitute total cost incurred by the patients. We fitted linear regression model to identify predictors of cost. Between onset of illness and anti-TB treatment course, patients incurred a median (inter-quartile range (IQR)) of US$201.48 (136.7-318.94). Of the total cost, the indirect and direct costs respectively constituted 70.6 and 29.4%. TB patients incurred a median (IQR) of US$97.62 (6.43-184.22) and US$93.75 (56.91-141.54) during the pre- and post-diagnosis periods, respectively. Thus, patients incurred 53.6% of the total cost during the pre-diagnosis period. Direct out-of-pocket expenses during the pre- and post-diagnosis periods respectively amount to median (IQR) of US$21.64 (10.23-48.31) and US$35.02 (0-70.04). Patient delay days (p < 0.001), provider delay days (p < 0.001), number of healthcare facilities visited until TB diagnosis (p < 0.001), and TB diagnosis at private facilities (p = 0.02) independently predicted increased pre-diagnosis cost. Similarly, rural residence (p < 0.001), hospitalization during anti-TB treatment (p < 0.001), patient delay days (p < 0.001), and provider delay days (p < 0.001) predicted increased post-diagnosis costs. TB patients

  17. Inbound marketing

    OpenAIRE

    Popek, Tomáš

    2011-01-01

    In my work I focus on Inbound Marketing, which represents a new perspective on marketing, that has not been given the attention it deserves. It is a combination of existing and proven marketing methods that are used to obtain new customers with minimal marketing costs to the organization. The first section of my work is devoted to defining the concept of Inbound Marketing definitions and explanations. Furthermore, I present a list of instruments used in Inbound Marketing, and showcase the def...

  18. Optimal Implantation Depth and Adherence to Guidelines on Permanent Pacing to Improve the Results of Transcatheter Aortic Valve Replacement With the Medtronic CoreValve System: The CoreValve Prospective, International, Post-Market ADVANCE-II Study.

    Science.gov (United States)

    Petronio, Anna S; Sinning, Jan-Malte; Van Mieghem, Nicolas; Zucchelli, Giulio; Nickenig, Georg; Bekeredjian, Raffi; Bosmans, Johan; Bedogni, Francesco; Branny, Marian; Stangl, Karl; Kovac, Jan; Schiltgen, Molly; Kraus, Stacia; de Jaegere, Peter

    2015-05-01

    The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis, Minnesota) using optimized implantation techniques and application of international guidelines on cardiac pacing. Conduction disturbances are a frequent complication of transcatheter aortic valve replacement. The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI. The primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth (≤6 mm below the aortic annulus). The timing and resolution of all new-onset conduction disturbances were analyzed. A total of 194 patients were treated. The overall rate of PPI for Class I/II indications was 18.2%. An optimal depth was reached in 43.2% of patients, with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm, compared with those with deeper implants (13.3% vs. 21.1%; p = 0.14). In a paired analysis, new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4% and 39.0% of patients, respectively, and resolved spontaneously within 30 days in 43.2% and 73.9%, respectively. In patients with new PPI, the rate of intrinsic sinus rhythm increased from 25.9% at 7 days to 59.3% at 30 days (p = 0.004). Optimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement, compared with results reported in previous studies. (CoreValve Advance-II Study: Prospective International Post-Market Study [ADVANCE II]; NCT01624870). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  19. Post-marketing surveillance study of the safety and efficacy of nalfurafine hydrochloride (Remitch® capsules 2.5 μg in 3,762 hemodialysis patients with intractable pruritus

    Directory of Open Access Journals (Sweden)

    Kozono H

    2018-01-01

    Full Text Available Hideki Kozono,* Hiroshi Yoshitani,* Ryoko Nakano* Pharmaceutical and Medical Device Vigilance Department, Toray Industries, Inc., Tokyo, Japan *The authors contributed equally to this work Background: Intractable pruritus in hemodialysis patients can significantly decrease their quality of life and is also associated with poor vital prognosis. Although combined multiple causes of intractable pruritus in these patients have been identified, no existing treatments are proven to be sufficiently effective. We conducted a post-marketing surveillance to follow-up and assess the safety and efficacy of nalfurafine, a selective κ-opioid receptor agonist, for the treatment of intractable pruritus in patients undergoing hemodialysis. Patients and methods: Hemodialysis patients with intractable pruritus from institutions in Japan who received oral nalfurafine hydrochloride between January 2010 and December 2013 were enrolled in the surveillance. Surveillance was completed in July 2015. Safety data during 1 year after nalfurafine treatment onset, and efficacy data of nalfurafine evaluating the first 12-week treatment period and the following period until 1 year after the initial dose of nalfurafine (using global assessment of the itch improvement by the physician, Visual Analog Scale, and the Shiratori’s severity scores were collected and analyzed. Results: In total, 3,762 patients were analyzed for safety. Adverse drug reactions were experienced by 402/3,762 (10.69% patients. The most frequent adverse drug reactions were insomnia (127/3,762 [3.38%] patients, constipation (34 [0.90%], somnolence (32 [0.85%], dizziness (23 [0.61%], nausea (13 [0.35%], and malaise (9 [0.24%]. No patients developed dependence on nalfurafine. Nalfurafine was effective in 82.50% (2,880/3,491 of patients during the first 12 weeks and in 84.95% (2,167/2,551 on treatment during the subsequent period until 1 year after nalfurafine treatment initiation. Statistically significant

  20. Harm promotion: observations on the symbiosis between government and private industries in Australasia for the development of highly accessible gambling markets.

    Science.gov (United States)

    Livingstone, Charles; Adams, Peter J

    2011-01-01

    To illustrate ways in which industry control over the gambling market and its regulatory system have enabled rapid proliferation in gambling consumption and harm. To discuss the relationship between government regulation and the accessibility, marketing and technologies of electronic gambling machines in Australia and New Zealand. The regulatory framework for gambling in both countries has encouraged highly accessible,regressively distributed and heavily marketed high-impact electronic gambling machines. This framework has developed in large part through the conjunction of government revenue needs and the adaptation of a folk model of gambling appropriated by gambling businesses and engineered to incorporate a discourse that legitimate their gambling businesses. Governments should be encouraged to invest in 'upstream' public health strategies that contain the economic and social drivers for intensifying gambling consumption. One key aspect involves questioning the most suitable scale, location and marketing of gambling operations, and the reliance of government on gambling revenues (whether directly or as substitution for other government expenditure). Technological solutions to disrupt the development of obsessive gambling habits are also available and are likely to reduce gambling-related harm.

  1. Markets, Bodies, Rhythms

    DEFF Research Database (Denmark)

    Borch, Christian; Bondo Hansen, Kristian; Lange, Ann-Christina

    2015-01-01

    to respond to a widely perceived problem, namely that market rhythms might be contagious and that some form of separation of bodily and market rhythms might therefore be needed. Finally, we show how current high-frequency trading, despite being purely algorithmic, does not render the traders' bodies......This article explores the relationship between bodily rhythms and market rhythms in two distinctly different financial market configurations, namely the open-outcry pit (prevalent especially in the early 20th century) and present-day high-frequency trading. Drawing on Henri Lefebvre......'s rhythmanalysis, we show how traders seek to calibrate their bodily rhythms to those of the market. We argue that, in the case of early-20th-century open-outcry trading pits, traders tried to enact a total merger of bodily and market rhythms. We also demonstrate how, in the 1920s and '30s, market observers began...

  2. Effect of early supplemental parenteral nutrition in the paediatric ICU: a preplanned observational study of post-randomisation treatments in the PEPaNIC trial.

    Science.gov (United States)

    Vanhorebeek, Ilse; Verbruggen, Sascha; Casaer, Michaël P; Gunst, Jan; Wouters, Pieter J; Hanot, Jan; Guerra, Gonzalo Garcia; Vlasselaers, Dirk; Joosten, Koen; Van den Berghe, Greet

    2017-06-01

    Large randomised controlled trials have shown that early supplemental parenteral nutrition in patients admitted to adult and paediatric intensive care units (PICUs) is harmful. Overdosing of energy with too little protein was suggested as a potential reason for this. This study analysed which macronutrient was associated with harm caused by early supplemental parenteral nutrition in the Paediatric Early versus Late Parenteral Nutrition In Critical Illness (PEPaNIC) randomised trial. Patients in the initial randomised controlled trial were randomly assigned to receive suppplemental parenteral nutrition (PN) within 24 h of PICU admission (early PN) or to receive such PN after 1 week (late PN) when enteral nutrition was insufficient. In this post-randomisation, observational study, doses of glucose, lipids, and aminoacids administered during the first 7 days of PICU stay were expressed as % of reference doses from published clinical guidelines for age and weight. Independent associations between average macronutrient doses up to each of the first 7 days and likelihood of acquiring an infection in the PICU, of earlier live weaning from mechanical ventilation, and of earlier live PICU discharge were investigated using multivariable Cox proportional hazard analyses. The three macronutrients were included in the analysis simultaneously and baseline risk factors were adjusted for. From June 18, 2012, to July 27, 2015, 7519 children aged between newborn and 17 years were assessed for eligibility. 6079 patients were excluded, and 1440 children were randomly assigned to receive either early PN (n=723) or late PN (n=717). With increasing doses of aminoacids, the likelihood of acquiring a new infection was higher (adjusted hazard ratios [HRs] per 10% increase between 1·043-1·134 for days 1-5, p≤0·029), while the likelihood of earlier live weaning from mechanical ventilation was lower (HRs 0·950-0·975 days 3-7, p≤0·045), and the likelihood of earlier live PICU

  3. Marijuana-Related Posts on Instagram.

    Science.gov (United States)

    Cavazos-Rehg, Patricia A; Krauss, Melissa J; Sowles, Shaina J; Bierut, Laura J

    2016-08-01

    Instagram is a highly visual social networking site whose audience continues to grow, especially among young adults. In the present study, we examine marijuana-related content on Instagram to better understand the varied types of marijuana-related social networking occurring on this popular social media platform. We collected 417,561 Instagram posts with marijuana-related hashtags from November 29 to December 12, 2014. We assessed content of a random sample (n = 5000) of these posts with marijuana-related hashtags. Approximately 2136 (43 %) were explicit about marijuana and further analyzed. Of the 2136 marijuana-related posts, images of marijuana were common (n = 1568). Among these 1568 marijuana images, traditional forms (i.e., buds/leaves) were the most common (63 %), followed by some novel forms of marijuana, including marijuana concentrates (20 %). Among the 568 posts that displayed marijuana being ingested, 20 % showed someone dabbing marijuana concentrates. Marijuana-related advertisements were also observed among the 2136 marijuana-related posts (9 %). Our findings signal the promotion of marijuana use in its traditional plant-based form; trendy and novel modes of marijuana ingestion were also endorsed. This content along with the explicit marketing of marijuana that we observed on Instagram have potential to influence social norms surrounding marijuana use.

  4. Marijuana-Related Posts on Instagram

    Science.gov (United States)

    Krauss, Melissa J.; Sowles, Shaina J.; Bierut, Laura J.

    2016-01-01

    Instagram is a highly visual social networking site whose audience continues to grow, especially among young adults. In the present study, we examine marijuana-related content on Instagram to better understand the varied types of marijuana-related social networking occurring on this popular social media platform. We collected 417,561 Instagram posts with marijuana-related hashtags from November 29 to December 12, 2014. We assessed content of a random sample (n = 5000) of these posts with marijuana-related hashtags. Approximately 2136 (43 %) were explicit about marijuana and further analyzed. Of the 2136 marijuana-related posts, images of marijuana were common (n = 1568). Among these 1568 marijuana images, traditional forms (i.e., buds/leaves) were the most common (63 %), followed by some novel forms of marijuana, including marijuana concentrates (20 %). Among the 568 posts that displayed marijuana being ingested, 20 % showed someone dabbing marijuana concentrates. Marijuana-related advertisements were also observed among the 2136 marijuana-related posts (9 %). Our findings signal the promotion of marijuana use in its traditional plant-based form; trendy and novel modes of marijuana ingestion were also endorsed. This content along with the explicit marketing of marijuana that we observed on Instagram have potential to influence social norms surrounding marijuana use. PMID:27262456

  5. Government intervention and market integration in Indonesian rice markets

    OpenAIRE

    Ismet, Mohammad; Barkley, Andrew P.; Llewelyn, Richard V.

    1998-01-01

    Long-run spatial price relationships in Indonesian rice markets and factors affecting the degree of market integration are evaluated using multivariate cointegration tests with weekly price data for the 1982-1993 period. The analysis includes evaluation of pre-self-sufficiency and post-self-sufficiency periods as well as for the entire period. The cointegration tests for entire Indonesian rice market, represented by the nine most relevant price series, indicate that relative to the pre-selfsu...

  6. Effects of institutional changes on land use: agricultural land abandonment during the transition from state-command to market-driven economies in post-Soviet Eastern Europe

    International Nuclear Information System (INIS)

    Prishchepov, Alexander V; Müller, Daniel; Radeloff, Volker C; Baumann, Matthias; Kuemmerle, Tobias

    2012-01-01

    Institutional settings play a key role in shaping land cover and land use. Our goal was to understand the effects of institutional changes on agricultural land abandonment in different countries of Eastern Europe and the former Soviet Union after the collapse of socialism. We studied ∼273 800 km 2 (eight Landsat footprints) within one agro-ecological zone stretching across Poland, Belarus, Latvia, Lithuania and European Russia. Multi-seasonal Landsat TM/ETM + satellite images centered on 1990 (the end of socialism) and 2000 (one decade after the end of socialism) were used to classify agricultural land abandonment using support vector machines. The results revealed marked differences in the abandonment rates between countries. The highest rates of land abandonment were observed in Latvia (42% of all agricultural land in 1990 was abandoned by 2000), followed by Russia (31%), Lithuania (28%), Poland (14%) and Belarus (13%). Cross-border comparisons revealed striking differences; for example, in the Belarus–Russia cross-border area there was a great difference between the rates of abandonment of the two countries (10% versus 47% of abandonment). Our results highlight the importance of institutions and policies for land-use trajectories and demonstrate that radically different combinations of institutional change of strong institutions during the transition can reduce the rate of agricultural land abandonment (e.g., in Belarus and in Poland). Inversely, our results demonstrate higher abandonment rates for countries where the institutions that regulate land use changed and where the institutions took more time to establish (e.g., Latvia, Lithuania and Russia). Better knowledge regarding the effects of such broad-scale change is essential for understanding land-use change and for designing effective land-use policies. This information is particularly relevant for Northern Eurasia, where rapid land-use change offers vast opportunities for carbon balance and

  7. An Examination of Market Entry Perspectives in Emerging Markets

    Directory of Open Access Journals (Sweden)

    Marvin O. Bates

    2017-11-01

    Full Text Available Purpose – The purpose of this article is to describe the marketing-oriented market entry approaches that businesses are currently using across the three levels of the world economic pyramid (i.e., WEP. These levels are the Top-tier, the Middle-tier, and the Base of the Pyramid-tier (i.e., BoP-tier. Methodology – The literature of the BoP was reviewed, and market entry approaches were itemized across the three WEP levels. Secondly, BoP strategic theorists including Prahalad identified the need for a BoP marketing focus replacing the traditional 4Ps marketing approach (i.e., Product, Price, Place and Promotion with the BoP-specific 4As marketing approach (i.e., Awareness, Affordability, Access and Availability. This 4As marketing approach is discussed. Findings – New marketing-oriented market-entry approaches are proposed for each of the three WEP levels. These approaches are based on where in the WEP the firm currently exists, and where in the WEP the firm desires to refocus market-entry activities; identified approaches include: inter-country expansion, intra-country entry, adjacent market entry, and extended market entry. Secondly, the absence of a clearly articulated marketing strategy for middle-tier markets was observed. Practical implications – This article has two specific applications. First, it summarizes the evolving market entry perspectives to provide a context for future market research in both emerging markets and the pre-emerging BoP markets. Second, the future requirement for an articulated marketing strategy for middle-tier markets is suggested. Originality – This article examined existing market entry approaches across all three levels of the WEP, inclusive of the BoP economic level. The language used to clarify market entry movements was extended, providing a specificity of description not previously found in either the existing market entry or BoP literature.

  8. Stock Market Liquidity: Comparative Analysis of Croatian and Regional Markets

    Directory of Open Access Journals (Sweden)

    Vladimir Benić

    2008-12-01

    Full Text Available On the Croatian stock market liquidity has never been in the focus of academic research thus we find it necessary to observe liquidity at the aggregate level. This paper observes multi-dimensional liquidity through the impact of turnover on price change together with several one-dimensional measures. In our empirical research we applythe illiquidity measureto seven different stock markets. We focus on the Croatian stock market as compared to other markets in the Central and Eastern Europe and German market. The results of the research indicate a substantial level of illiquidity in the Croatian and other developing markets.

  9. The market for firms

    DEFF Research Database (Denmark)

    Davis, Jerome Dean; Keiding, Hans

    2010-01-01

    and as a consequence a higher sales value of the firm. Buyers take this signaling into consideration, but irrespective of their countermoves, the equilib- rium result may be a lowering of ex ante product prices, and an ex post market overvaluation of the firm. This model is utilized to suggest possible explanations...

  10. gender-specific outcome after paclitaxel-eluting stent implantation in japanese patients with coronary artery disease--sub-analysis of the Japan TAXUS Express2 post-marketing survey.

    Science.gov (United States)

    Okura, Hiroyuki; Nakamura, Masato; Kotani, Jun-Ichi; Kozuma, Ken

    2013-01-01

     Although previous randomized and non-randomized studies have demonstrated the safety and efficacy of paclitaxel-eluting stents (PES), a higher revascularization rate has been reported in women than in men. A sub-analysis of the TAXUS Japan Post-market Surveillance Study (TAXUS-PMS) was done to assess the influence of gender on clinical outcome.  A total of 2,132 PES-treated Japanese patients (women, n=551) from this registry were analyzed. Subjects were stratified by gender to compare 1-year clinical outcome. PES-treated women were older and more likely to have insulin-treated diabetes and hypertension. In contrast, PES-treated men were more likely to be smokers, have a previous history of myocardial infarction, and lower ejection fraction. While cardiac death, myocardial infarction and stent thrombosis were similar between men and women, major cardiac events tended to be lower in women than in men (6.4% vs. 8.8%, P=0.08). Although women had significantly smaller reference vessel size (2.46±0.53 mm vs. 2.59±0.60 mm, Ptarget lesion revascularization rate was significantly lower in women than in men (4.2% vs. 6.5%, P<0.05).  Despite a higher risk profile, Japanese women treated with PES did not have a higher rate of repeat revascularization or major adverse clinical outcome than PES-treated men at 1 year. 

  11. Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.

    Science.gov (United States)

    Seltzer, Jonathan H; Heise, Ted; Carson, Peter; Canos, Daniel; Hiatt, Jo Carol; Vranckx, Pascal; Christen, Thomas; Cutlip, Donald E

    2017-08-01

    This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding (1) rationale for when adjudication is appropriate, (2) best practices establishment and operation of a medical device adjudication committee and (3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence. Copyright © 2017. Published by Elsevier Inc.

  12. Safety and efficacy of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice: interim results of the STELLA-LONG TERM post-marketing surveillance study.

    Science.gov (United States)

    Nakamura, Ichiro; Maegawa, Hiroshi; Tobe, Kazuyuki; Tabuchi, Hiromi; Uno, Satoshi

    2018-02-01

    Data regarding the efficacy and safety of sodium-glucose cotransporter 2 inhibitors in the real-world setting in Japan are limited. The STELLA-LONG TERM study is an ongoing 3-year post-marketing surveillance study of ipragliflozin in type 2 diabetes (T2D) patients. Here, we report the interim results (including 3-, 12-, and 24-month data). All Japanese patients with T2D who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015 at participating centers in Japan were registered in STELLA-LONG TERM. At 3, 12, and 24 months, the safety analysis set comprised 11,053, 5475, and 138 patients, respectively; the efficacy analysis set comprised 8757 patients. Ipragliflozin treatment resulted in statistically significant improvements versus baseline in hemoglobin A1c, fasting plasma glucose concentration, body weight, blood pressure, heart rate, and serum concentrations of low-density lipoprotein cholesterol and triglycerides. The adverse drug reaction incidence rate was 10.71%, the most common reactions being renal and urinary disorders (5.06%), infections and infestations (1.24%), and skin and subcutaneous tissue disorders (1.14%). Ipragliflozin was well tolerated and effective in Japanese patients with T2D; no new safety issues were identified.

  13. Sustainable Marketing

    NARCIS (Netherlands)

    Dam, van Y.K.

    2017-01-01

    In this article, three different conceptions of sustainable marketing are discussed and compared. These different conceptions are referred to as social, green, and critical sustainable marketing. Social sustainable marketing follows the logic of demand-driven marketing management and places the

  14. Entry, concentration and market efficiency: A simulation of the PJM energy market

    Science.gov (United States)

    Harvill, Terry

    The rapid and substantial expansion of the PJM energy market during 2004 and 2005 provides a unique opportunity to test the theory of market concentration and its effect on market efficiency. With ten years of operational experience, the PJM energy market is uniquely suited to test the theories of market concentration and efficiency in a natural experiment. This research tests the hypothesis that, for a given number of generating units in the industry, system marginal price will be a decreasing function of the number of owners or generators controlling the units (i.e., the industry concentration ratio). Market simulations are utilized to assess price-cost markups in the PJM energy market during three distinct periods of expansion: (1) pre-Commonwealth Edison integration, (2) pre-American Electric Power (AEP), Dayton Power and Light (DPL), Duquesne Light (Duquesne), and Dominion Virginia Power (Dominion) integration, and (3) post-AFT, DPL. Duquesne, and Dominion Integration. The results of the market simulations for the May 1 to August 31 periods for 2003, 2004, and 2005, indicate that the performance of the market improved with the addition of new market participants in 2004 and 2005. The results of the simulation indicate that the load-weighted Lerner index decreased to -3.70 percent in 2005 from 0.92 percent in 2003. Clearly, the addition of Commonwealth Edison in 2004 significantly increased constraints within the PJM energy market and likely impacted the observed prices in PJM during 2004 due to the lack of a significant link to the other PJM market participants. This deficiency was address in 2005 with the addition of American Electric Power. The market simulations also highlight the prevalence of computed negative markups in the simulation results. Many of the off-peak periods in particular are characterized by negative markups where the expected marginal cost exceeds the observed price. Unit commitment constraints are believed to largely account for these

  15. Commentary: An Introduction to Leadership Self-Assessment at the Society of Neurological Surgeons Post-Graduate Year 1 Boot Camp: Observations and Commentary.

    Science.gov (United States)

    Hunt, Matthew A; Heilman, Carl B; Shutran, Max; Wu, Julian K

    2017-03-01

    Recent trends in graduate medical education have emphasized the mastery of nontechnical skills, especially leadership, for neurosurgical trainees. Accordingly, we introduced leadership development and self-awareness training to interns attending the Society of Neurological Surgeons Post-Graduate Year 1 Boot Camp in the Northeast (New England/New York/New Jersey) region in 2015. Feedback about the session was collected from interns. While neurosurgical interns conveyed a desire to receive more information on improving their leadership skills, most indicated that guidance seemed to be lacking in this critical area. We discuss some of the professional development needs uncovered during this process. Copyright © 2017 by the Congress of Neurological Surgeons.

  16. Health of men, women, and children in post-trafficking services in Cambodia, Thailand, and Vietnam: an observational cross-sectional study.

    Science.gov (United States)

    Kiss, Ligia; Pocock, Nicola S; Naisanguansri, Varaporn; Suos, Soksreymom; Dickson, Brett; Thuy, Doan; Koehler, Jobst; Sirisup, Kittiphan; Pongrungsee, Nisakorn; Nguyen, Van Anh; Borland, Rosilyne; Dhavan, Poonam; Zimmerman, Cathy

    2015-03-01

    Trafficking is a crime of global proportions involving extreme forms of exploitation and abuse. Yet little research has been done of the health risks and morbidity patterns for men, women, and children trafficked for various forms of forced labour. We carried out face-to-face interviews with a consecutive sample of individuals entering 15 post-trafficking services in Cambodia, Thailand, and Vietnam. We asked participants about living and working conditions, experience of violence, and health outcomes. We measured symptoms of anxiety and depression with the Hopkins Symptoms Checklist and post-traumatic stress disorder with the Harvard Trauma Questionnaire, and used adjusted logistic regression models to estimate the effect of trafficking on these mental health outcomes, controlling for age, sector of exploitation, and time in trafficking. We interviewed 1102 people, of whom 1015 reached work destinations. Participants worked in various sectors including sex work (329 [32%]), fishing (275 [27%]), and factories (136 [13%]). 481 (48%) of 1015 experienced physical violence, sexual violence, or both, with 198 (35%) of 566 women and girls reporting sexual violence. 478 (47%) of 1015 participants were threatened and 198 (20%) were locked in a room. 685 (70%) of 985 who had data available worked 7 days per week and 296 (30%) of 989 worked at least 11 hours per day. 222 (22%) of 983 had a serious injury at work. 61·2% (95% CI 58·2-64·2) of participants reported symptom of depression, 42·8% (39·8-45·9) reported symptoms of anxiety, and 38·9% (36·0-42·0) reported symptoms of post-traumatic stress disorder. 5·2% (4·0-6·8) had attempted suicide in the past month. Participants who experienced extremely excessive overtime at work, restricted freedom, bad living conditions, threats, or severe violence were more likely to report symptoms of depression, anxiety, and post-traumatic stress disorder. This is the first health study of a large and diverse sample of men, women

  17. TRICARE Marketing

    Science.gov (United States)

    1999-10-21

    definitive. It stated that: Marketing is much more than advertising or promotion materials. Marketing is a foundation for building a business strategy ; it...objectives, and strategies for marketing TRICARE. However, the Director provided the plan for information; none of the recipients of the plan were...overarching goal and extensively in the marketing strategies section. Specifically, the Marketing Plan states that strategies employed to accomplish

  18. Hospital marketing.

    Science.gov (United States)

    Carter, Tony

    2003-01-01

    This article looks at a prescribed academic framework for various criteria that serve as a checklist for marketing performance that can be applied to hospital marketing organizations. These guidelines are drawn from some of Dr. Noel Capon of Columbia University's book Marketing Management in the 21st Century and applied to actual practices of hospital marketing organizations. In many ways this checklist can act as a "marketing" balanced scorecard to verify performance effectiveness and develop opportunities for innovation.

  19. Internet marketing

    OpenAIRE

    Zelený, Martin

    2009-01-01

    In the bachelor thesis are introduced theoretical concepts of the Internet and marketing, accented the need of marketing mix along with its specifics of the internet environment. Next is interpreted which tools can be used for marketing of firms and which marketing instruments are to be deployed. Final chapter illustrates socio-demographics of Czech internet users along with media market allocation from the perspective of all media as well as in the segment of the Internet.

  20. Money Markets

    OpenAIRE

    Marvin Goodfriend

    2011-01-01

    Money markets offer monetary services and short-term finance in the capital market with the credit support of institutional sponsors. Investors finance money market instruments at low interest because their salability on short notice confers an implicit monetary services yield. Low interest attracts borrowers to money markets. The fragile equilibrium depends on collective confidence in the credit quality of instruments supplied to the market. Federal Reserve monetary and credit policies have ...

  1. Computer Security: posting and mis-posting

    CERN Multimedia

    Stefan Lueders, Computer Security Team

    2015-01-01

    This is what can happen at CERN if you don't lock your computer screen...   “Hi, I am looking for a partner either male or female to attend salsa lessons. I have a great body and enjoy rubbing it against other people on the dance floor. I would consider dinner after with the right person. If you think you can keep up with me and enjoy getting sweaty send me a reply. Stay sexy…” This is the original text of a recent posting on the CERN Market webpage. Some people might find this appealing, some people think this is funny. Personally, I couldn’t care less. But professionally, we had to follow up as this text can be perceived as inappropriate and, thus, in violation of the Terms of Usage of the CERN Market as well as the CERN Computing Rules and its annex on private usage of the CERN computing facilities. We remind you that the CERN Market is a public website that can be used by people within but also outside CERN. All posts are visible world...

  2. Post cardiac injury syndrome

    DEFF Research Database (Denmark)

    Nielsen, S L; Nielsen, F E

    1991-01-01

    The post-pericardiotomy syndrome is a symptom complex which is similar in many respects to the post-myocardial infarction syndrome and these are summarized under the diagnosis of the Post Cardiac Injury Syndrome (PCIS). This condition, which is observed most frequently after open heart surgery, i...... on the coronary vessels, with cardiac tamponade and chronic pericardial exudate. In the lighter cases, PCIS may be treated with NSAID and, in the more severe cases, with systemic glucocorticoid which has a prompt effect....

  3. On the Design of Artificial Stock Markets

    NARCIS (Netherlands)

    K. Boer-Sorban (Katalin); A. de Bruin (Arie); U. Kaymak (Uzay)

    2005-01-01

    textabstractArtificial stock markets are designed with the aim to study and understand market dynamics by representing (part of) real stock markets. Since there is a large variety of real stock markets with several partially observable elements and hidden processes, artificial markets differ

  4. Registries in European post-marketing surveillance

    DEFF Research Database (Denmark)

    Bouvy, Jacoline C; Blake, Kevin; Slattery, Jim

    2017-01-01

    at gaining further insight into the European Medicines Agency's (EMA) requests for new registries and registry studies using existing registries and to review the experience gained in their conduct. METHODS: European Public Assessment Reports were consulted to identify products for which a request...

  5. Marketing fundamentals.

    Science.gov (United States)

    Redmond, W H

    2001-01-01

    This chapter outlines current marketing practice from a managerial perspective. The role of marketing within an organization is discussed in relation to efficiency and adaptation to changing environments. Fundamental terms and concepts are presented in an applied context. The implementation of marketing plans is organized around the four P's of marketing: product (or service), promotion (including advertising), place of delivery, and pricing. These are the tools with which marketers seek to better serve their clients and form the basis for competing with other organizations. Basic concepts of strategic relationship management are outlined. Lastly, alternate viewpoints on the role of advertising in healthcare markets are examined.

  6. Politisk marketing

    DEFF Research Database (Denmark)

    Disciplinen politisk marketing er udbredt i mange vestlige lande. Imidlertid er kendskabet til politisk marketing i Danmark bemærkelsesværdigt lavt. I det lys er denne bog Politisk Marketing: Personer, Partier & Praksis den første bog i Danmark, som -ud fra marketing- indkredser de sidste mange års...... brudflader i dansk politik. Gennem ti bidrag fra forskere og praktikere udskraber forfatterne et DNA for feltet politisk marketing. Kort sagt kan du i denne bog finde svarene på: Hvad er politisk marketing? Hvordan har det udviklet sig? Og hvilke konsekvenser har dette fænomen for vælgere, partier og...

  7. Comparison of Sellers's Awareness to Environmental Hygiene of Market Bulak, Market Klender and Market Rawamangun, East Jakarta

    Science.gov (United States)

    Maulidya, Hasana P.

    2018-02-01

    This research is motivated by the difference of market hygiene condition, where the market hygiene level is influenced by the environment around the market. In general, markets located near densely populated housing tend to be overlooked, while markets near elite housing tend to be clean. This condition is also influenced by marketers' awareness of market hygiene. If the market is near the elite neighbourhood, the level of awareness of sellers on cleanliness will be high. If the market is located in a densely populated area, sellers generally do not pay attention to cleanliness. The purpose of this research is to know the sellers's awareness of environmental cleanliness of Market Bulak, Klender Market and Rawamangun Market. Respondents in this study are sellers and buyers who make transactions in these 3 markets. This type of research is descriptive analysis with the method of observation and interview to 10 sellers in each market. Seller hygiene awareness are poor.

  8. To market, to market

    International Nuclear Information System (INIS)

    Lieberman, J.I.

    1992-01-01

    Senator Lieberman and three fellow members of Congress introduced the CO 2 Offset Policy Efficiency Act (COPE), which incorporates the use of marketable permits to reduce CO 2 emissions. For COPE to be fully effective, however, several key criteria must be met: (1) establishing initial baselines will be critical to ensure that emission reductions are credited properly; (2) accurate plant-by-plant monitoring must be in place to ensure that claimed reductions have actually occurred; (3) the program must include a strong enforcement provision to prevent evasion and to punish violators with substantial automatic fines. COPE imposes a sanction equal to roughly four times the estimated cost of offsets; the sanctions would be paid before enforcement proceedings commence. The urgency and complexity of global warming requires us to break with the past and develop new ways of delaying with pollution, Senator Lieberman feels by giving the market a chance to work on behalf of the environment, the sale of emission allowance will reduce CO 2 emissions in the most-efficient cost-effective way possible

  9. The Indian Stock Market and the Great Recession

    Directory of Open Access Journals (Sweden)

    Arindam MANDAL

    2012-03-01

    Full Text Available This study analyzes the impact of the outbreak of the Great Recession of 2007 on the behavior of the Indian stock market. The SENSEX index of the Bombay Stock Exchange is analyzed for the prerecession period of January 2002 – November 2007 and the postrecession outbreak period of December 2007 – July 2010. Substantial increase in SENSEX return volatility observed during the post-recession outbreak period, whereas no substantial difference in returns between two periods is found. Also strong co-movements in returns and volatility are observed between the SENSEX and other major stock indexes during the post-recession period. Our results establish the dominance of global factors in influencing Indian stock market behavior during periods of economic turmoil.

  10. Market analysis and market evaluation as well as a creation of a concept for the market observation for selected services within the energy efficiency. Final report; Marktanalyse und Marktbewertung sowie Erstellung eines Konzeptes zur Marktbeobachtung fuer ausgewaehlte Dienstleistungen im Bereich Energieeffizienz. Endbericht

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-07-05

    The Directive on energy efficiency and energy services obliges the Member States to reduce the energy consumption by 9 % up to the year 2016 and to promote the market for energy services. The objectives set at different levels for energy efficiency and energy savings can be achieved more effectively and efficiently with functioning markets for energy services, energy audits and measures for improving the energy efficiency. The contribution under consideration deals with the following topics: (a) Sectoral differentiated analysis of markets for energy services, energy audits and other energy efficiency measures; (b) Recommendations and suggestions for further development of the analyzed markets; (c) Development of a concept for the future, regular monitoring of the analyzed markets by the Federal Ministry for Energy Efficiency (Eschborn, Federal Republic of Germany); (d) Development of meaningful key performance indicators; (e) Description and evaluation of beneficial and obstructive factors.

  11. MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population.

    Science.gov (United States)

    Di Biase, Luigi; Tung, Roderick; Szili-Torok, Tamás; Burkhardt, J David; Weiss, Peter; Tavernier, Rene; Berman, Adam E; Wissner, Erik; Spear, William; Chen, Xu; Neužil, Petr; Skoda, Jan; Lakkireddy, Dhanunjaya; Schwagten, Bruno; Lock, Ken; Natale, Andrea

    2017-04-01

    Patients with ischemic cardiomyopathy (ICM) are prone to scar-related ventricular tachycardia (VT). The success of VT ablation depends on accurate arrhythmogenic substrate localization, followed by optimal delivery of energy provided by constant electrode-tissue contact. Current manual and remote magnetic navigation (RMN)-guided ablation strategies aim to identify a reentry circuit and to target a critical isthmus through activation and entrainment mapping during ongoing tachycardia. The MAGNETIC VT trial will assess if VT ablation using the Niobe™ ES magnetic navigation system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT and low ejection fraction. This is a randomized, single-blind, prospective, multicenter post-market study. A total of 386 subjects (193 per group) will be enrolled and randomized 1:1 between treatment with the Niobe ES system and treatment via a manual procedure at up to 20 sites. The study population will consist of patients with ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) of ≤35% and implantable cardioverter defibrillator (ICD) who have sustained monomorphic VT. The primary study endpoint is freedom from any recurrence of VT through 12 months. The secondary endpoints are acute success; freedom from any VT at 1 year in a large-scar subpopulation; procedure-related major adverse events; and mortality rate through 12-month follow-up. Follow-up will consist of visits at 3, 6, 9, and 12 months, all of which will include ICD interrogation. The MAGNETIC VT trial will help determine whether substrate-based ablation of VT with RMN has clinical advantages over manual catheter manipulation. Clinicaltrials.gov identifier: NCT02637947.

  12. Long-Term Effectiveness of the Zilver PTX Drug-Eluting Stent for Femoropopliteal Peripheral Artery Disease in Patients with No Patent Tibial Runoff Vessels-Results from the Zilver PTX Japan Post-Market Surveillance Study.

    Science.gov (United States)

    Cipollari, Stefano; Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Saunders, Alan T; Dake, Michael D

    2018-01-01

    To evaluate 2-year results of the Zilver PTX (Cook Medical, Bloomington, Indiana) drug-eluting stent (DES) for femoropopliteal peripheral artery disease (PAD) in patients with no continuous patent infrapopliteal runoff arteries compared with patients with ≥ 1 continuous patent runoff vessels. A retrospective analysis of patients with femoropopliteal PAD enrolled in the Zilver PTX Post-Market Surveillance Study in Japan was performed. There were no exclusion criteria. Outcomes, including freedom from target lesion revascularization (TLR), patency, and clinical benefit, for the no-runoff group (n = 54) were compared with the runoff group (n = 846). The 2 groups were similar in terms of demographics, lesion characteristics, and comorbidities (P > .05). There was a higher incidence of critical limb ischemia in the no-runoff group compared with the runoff group (44.8% vs 19.7%; P < .01). There were 3 amputations (5.6%) in the no-runoff group versus 7 amputations (0.8%) in the runoff group (P = .02). At 2 years, freedom from TLR rates were 81.3% versus 83.8% (P = .87), patency rates were 68.4% versus 70.7% (P = .95), and clinical benefit rates were 73.7% versus 80.0% (P = .16) in the no-runoff versus runoff group, respectively. Results in patients with no continuous patent tibial runoff were favorable through 2 years and similar to results for patients with ≥ 1 continuous patent runoff vessels, indicating that the Zilver PTX DES may be a valid treatment option for patients with these difficult-to-treat lesions. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

  13. Optical Coherence Tomography Substudy of A Prospective Multicenter Randomized Post-Market Trial to Assess the Safety and Effectiveness of the Firehawk™ Rapamycin Target Eluting Cobalt Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesions: TARGET All Comers.

    Science.gov (United States)

    Baumbach, Andreas; Lansky, Alexandra J; Onuma, Yoshi; Asano, Taku; Johnson, Thomas; Anderson, Richard; Kiemeneij, Ferdinand; Zheng, Ming; Van Royen, Niels; Slagboom, Ton; Vlachojannis, Georg; Xu, Bo; Serruys, Patrick; Wijns, William

    2018-06-12

    Durable polymer drug-eluting stents (DP DES) may contribute to persistent inflammation, delayed endothelial healing and subsequent late DES thrombosis. The aim of this Optical Coherence Tomography (OCT) sub-study was to compare healing and neointimal coverage of a novel bioabsorbable polymer sirolimus-eluting stent (FIREHAWK®) (BP DES) versus the DP DES (XIENCE) at 90 days in an all comers patient population. The TARGET All Comers study is a prospective multicenter randomised post-market trial of 1656 patients randomised 1:1 to FIREHAWK or XIENCE at 21 centers in 10 European countries. The TARGET OCT sub-study enrolled 36 consecutive patients with 52 lesions at 6 centers proficient in OCT. Follow-up OCT was performed at 3 months or prior to revascularisation when occurring before the 3-month window. The substudy was designed for non-inferiority of the primary endpoint of neointimal thickness. At follow-up, the mean neointimal thickness by OCT (52 lesions, Firehawk, n=24; Xience, n=28), was not significantly different between groups (Firehawk 75.5μm vs Xience V 82.3 μm) meeting the primary endpoint of non-inferiority (Pnoninferiority<0.001). The percentage of stent strut coverage was high in both groups (strut level: 99.9% ± 0.3 vs 100% ± 0.1, p=0.26), and the proportion of malapposed struts (1.0±1.6% vs. 1.2±2.0%, p=0.51) was low in both groups. Based on OCT, the FIREHAWK BP DES has a similar healing response 3 months after implantation compared to the DP DES, with near complete strut coverage, moderate neointima formation and minimal strut malapposition.

  14. The sirolimus-eluting Cypher Select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis: insights from the e-SELECT (Multicenter Post-Market Surveillance) registry.

    Science.gov (United States)

    Abizaid, Alexandre; Costa, J Ribamar; Banning, Adrian; Bartorelli, Antonio L; Dzavik, Vladimir; Ellis, Stephen; Gao, Runlin; Holmes, David R; Jeong, Muyng Ho; Legrand, Victor; Neumann, Franz-Josef; Nyakern, Maria; Orlick, Amy; Spaulding, Christian; Worthley, Stephen; Urban, Philip M

    2012-01-01

    This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients. There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR. The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year. Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively). Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  15. Post-Cruise Questionnaire - Legacy

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The Post-Cruise Questionnaire is a mandatory post trip legal document that observers fill out after every trip they have completed.

  16. The Indian Stock Market and the Great Recession

    OpenAIRE

    Arindam MANDAL; Prasun BHATTACHARJEE

    2012-01-01

    This study analyzes the impact of the outbreak of the Great Recession of 2007 on the behavior of the Indian stock market. The SENSEX index of the Bombay Stock Exchange is analyzed for the prerecession period of January 2002 – November 2007 and the postrecession outbreak period of December 2007 – July 2010. Substantial increase in SENSEX return volatility observed during the post-recession outbreak period, whereas no substantial difference in returns between two periods is...

  17. SPORT MARKETING

    OpenAIRE

    Omer Špirtović; Danilo Aćimović; Ahmet Međedović; Zoran Bogdanović

    2010-01-01

    Word „marketing“ comes from AngloSaxon linguistic domain and implies in a narrow sense the market. Under marketing, we consider certain process, which should create and solve relations of exchange between manufacturers on one side, and consumers on the other. Discussion about sport marketing implies its theoretical definition and generalization, and then its actual definition in sport environment. Sport marketing belongs to business function of sport organization and represents primaly an eco...

  18. Mobile marketing

    OpenAIRE

    KLEČKOVÁ, Zuzana

    2013-01-01

    The main aim of this thesis was to provide a comprehensive overview of the mobile marketing and analyze selected campaigns of Czech mobile marketing in comparison to world successful campaigns. The research contained studying of available literature about the theme to gain general knowledge about the issue. The theoretical part of the thesis contains predominantly various definitions of mobile marketing and its tools, advantages of these tools and some information about Mobile Marketing Assoc...

  19. Marketing Strategy

    OpenAIRE

    Andrýsková, Hana

    2013-01-01

    The aim of this thesis is to examine current marketing efforts of AARON - the leading seller of digital cameras. I will analyze current marketing tools and suggest improvements in efficiency and effectiveness of these tools. Marketing strategy is a method of managing and coordinating efforts in marketing field so that the goals can be reached. The aim is to increase sales, turnover, revenues, profits, drive out competition and also to build up a corporate image and corporate culture. I will a...

  20. A Marketing Perspective on Mergers and Acquisitions : How Marketing Integration Affects Postmerger Performance

    OpenAIRE

    Homburg, Christian; Bucerius, Matthias

    2004-01-01

    Previous research on mergers and acquisitions (M&A) has neglected marketing issues by and large. This paper examines the effects of post merger integration (PMI) in marketing (ex tent and speed of marketing integration) on M&A performance mediated by integration outcomes (magnitude of cost savings and market-related performance). Results from a survey of 232 horizontal mergers and acquisitions show that market-related performance after the merger or acquisition has a much stronger impac...

  1. Sympatho-vagal balance, as quantified by ANSindex, predicts post spinal hypotension and vasopressor requirement in parturients undergoing lower segmental cesarean section: a single blinded prospective observational study.

    Science.gov (United States)

    Prashanth, Anitha; Chakravarthy, Murali; George, Antony; Mayur, Rohini; Hosur, Rajathadri; Pargaonkar, Sumant

    2017-08-01

    Hypotension subsequent to spinal anesthesia occurs in a significant number of parturients undergoing lower segment caesarian section. Currently available methods to predict the incidence of hypotension, its severity and the outcome are sub-optimal. Many workers have used basal heart rate as one of the predictors. But using this method it is not possible to objectively analyze and predict the extent and severity of hypotension. We used an equipment measuring the level of sympatho-vagal balance, ANSiscope™, which derives these values from computed value of RR interval variability. We made a single measure of the value which was blinded to the patient and the anesthesiologist. We studied one hundred eight patients who underwent lower segment caesarian section under spinal anesthesia and found the variability of preoperative ANSindex (% activity displayed by the equipment) from 9 to 65 %. Higher ANSindex value was significantly associated with post spinal hypotension (p 0.017). A value of 24 % indicated the critical level above which hypotension appeared commonly. The ANSindex value might help anesthesiologist to anticipate and prepare for hypotension that is likely to ensue.

  2. Marketing 101.

    Science.gov (United States)

    Henderson, Karla A.

    1997-01-01

    A marketing model for camps includes a mix of services, presentation, and communication elements that promote the virtues of camp, convince potential campers and their families of the benefits of camp, and successfully distinguish the camp from others. Includes resources related to marketing strategies, theme merchandise, and market trends…

  3. MARKET WATCH

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    The hottest financial market topic of the moment could be the subprime loan crisis in the United States. The crisis has stormed the U.S. stock market, dragging it to its biggest falls in a single trading day. Other markets, such as Japan’s, were also vul

  4. Auto Market

    Institute of Scientific and Technical Information of China (English)

    2001-01-01

    <正> Editor’s notes: As China’s WTO entry is drawing near, Chinese people are witnessing the marketing activities of foreign automakers in China: establishing new firms and promoting new vehicles, etc. In face of the enormous Chinese market, foreign automakers are busy in establishing their brand images, fostering consumption population in order to take more market shares in the future.

  5. Service marketing

    Directory of Open Access Journals (Sweden)

    Babić-Hodović Vesna

    2002-01-01

    Full Text Available Development of postindustrial society and services revolution created numerous changes in size of consumer demand, consumer reaction and priorities. Continuous change on the side of demand and offer must follow changes in marketing orientation. Leader in that change is services marketing which by knowing services range and all the changes builds a new concept called Relationship Marketing.

  6. Friendship Interactions in Children with and without Depressive Symptoms: Observation of Emotion during Game-Playing Interactions and Post-Game Evaluations

    Science.gov (United States)

    Rockhill, Carol M.; Fan, Ming-Yu; Katon, Wayne J.; McCauley, Elizabeth; Crick, Nicki R.; Pleck, Joseph H.

    2007-01-01

    This observational study supplements the strong and consistent link found between childhood depression and deficits in interpersonal functioning by examining the relationship between a high versus low score on the Children's Depression Inventory (CDI) and children's emotions when interacting with their best friends. High-CDI and low-CDI target…

  7. [Post-partum thyroiditis].

    Science.gov (United States)

    Neves, Celestino; Alves, Marta; Delgado, Luís; Medina, J Luís

    2009-01-01

    In the post-partum period the immune alterations are associated with the multiple autoimmune diseases relapse. After birth, immune-tolerance variation slowly disappear, and is observed a return to a normal state - after an exacerbation period - of autoimmune reactivity, during which a great increase in T cells and autoantibodies is observed. In this period - 3 to 9 months after birth - the thyroid autoimmune disease relapses or reappears. The reactivation of the immune system in the post-partum period unchains an acute phase of celular destruction which characterizes the post-partum thyroiditis.

  8. Communication impacting financial markets

    Science.gov (United States)

    Vitting Andersen, Jørgen; Vrontos, Ioannis; Dellaportas, Petros; Galam, Serge

    2014-10-01

    Since the attribution of the Nobel prize in 2002 to Kahneman for prospect theory, behavioral finance has become an increasingly important subfield of finance. However the main parts of behavioral finance, prospect theory included, understand financial markets through individual investment behavior. Behavioral finance thereby ignores any interaction between participants. We introduce a socio-financial model (Vitting Andersen J. and Nowak A., An Introduction to Socio-Finance (Springer, Berlin) 2013) that studies the impact of communication on the pricing in financial markets. Considering the simplest possible case where each market participant has either a positive (bullish) or negative (bearish) sentiment with respect to the market, we model the evolution of the sentiment in the population due to communication in subgroups of different sizes. Nonlinear feedback effects between the market performance and changes in sentiments are taken into account by assuming that the market performance is dependent on changes in sentiments (e.g., a large sudden positive change in bullishness would lead to more buying). The market performance in turn has an impact on the sentiment through the transition probabilities to change an opinion in a group of a given size. The idea is that if for example the market has observed a recent downturn, it will be easier for even a bearish minority to convince a bullish majority to change opinion compared to the case where the meeting takes place in a bullish upturn of the market. Within the framework of our proposed model, financial markets stylized facts such as volatility clustering and extreme events may be perceived as arising due to abrupt sentiment changes via ongoing communication of the market participants. The model introduces a new volatility measure which is apt of capturing volatility clustering and from maximum-likelihood analysis we are able to apply the model to real data and give additional long term insight into where a market is

  9. How Private Creditors Fared in Emerging Debt Markets, 1970-2000

    OpenAIRE

    Klingen, Christoph; Weder di Mauro, Beatrice; Zettelmeyer, Jeromin

    2004-01-01

    We estimate ex post returns to emerging market debt by combining secondary-market prices with observed flows based on World Bank data. From 1970-2000, returns averaged 9 percent per annum, about the same as returns on a ten-year U.S. treasury bond. This reflects the combined effect of the 1980s debt crisis and much higher returns during 1989-2000. Annual returns since 1986 have been less volatile than emerging market equity returns but more volatile than returns on U.S. corporate or high-yiel...

  10. Translation and cultural validation of clinical observational scales - the Fugl-Meyer assessment for post stroke sensorimotor function in Colombian Spanish.

    Science.gov (United States)

    Barbosa, Nubia E; Forero, Sandra M; Galeano, Claudia P; Hernández, Edgar D; Landinez, Nancy S; Sunnerhagen, Katharina S; Alt Murphy, Margit

    2018-04-24

    Fugl-Meyer Assessment (FMA) is the most widely used and recommended clinical scale for evaluation of sensorimotor impairment post stroke, but an official Spanish version is not available today. This study aimed to establish methodological structure for translation and cultural adaptation process and perform a transcultural validation of the upper and lower extremity FMA to Colombian Spanish. Procedures included forward and backward translation, step-wise reviewing by bilingual and professional experts to ensure conceptual and semantic equivalence. Validation included a pilot evaluation of item-level agreement on 10 individuals with stroke at the Central Military Hospital of Colombia. Comprehensive step-wise procedure for transcultural validation was established. Low agreement (less than 70%) was detected for items assessing arm movements within synergies and for coordination/speed subscale. All points of disagreement were systematically reviewed and agreed upon when drafting the final version of the Spanish FMA. Use of FMA will allow unified description of stroke severity and motor recovery in Spanish speaking countries. This will open up possibility to compare stroke and rehabilitation outcomes with other countries and regions world-wide. Comprehensive methodological procedures provided can facilitate introduction of well-established clinical scales in other languages. Implications for Rehabilitation The Fugl-Meyer Assessment (FMA) of upper and lower extremity is the most used and recommended clinical scale for evaluation of sensorimotor impairment after stroke. The Spanish version of FMA, validated in this study, is now first time available for use in research and clinical practice. Use of FMA will allow unified description of stroke severity and motor recovery in Spanish speaking countries, which in turn opens up possibility to compare stroke and rehabilitation outcomes with other countries and regions world-wide.

  11. Marketing maloobchodu

    OpenAIRE

    Demuth, Jan

    2012-01-01

    This thesis is about the situation of retail marketing in Czech republic, with a special focus on in-store marketing instruments and activities. The goal of this work is to evaluate the application of these marketing instruments in a specific retail store. This chosen store is supermarket Billa. The first part of the thesis is offering theoretical base for in-store marketing activities and also presents the history of retail marketing in Czech republic. The second part is focusing on the situ...

  12. MARKETING CHANNELS

    Directory of Open Access Journals (Sweden)

    Ljiljana Stošić Mihajlović

    2014-07-01

    Full Text Available Marketing channel is a set of entities and institutions, completion of distribution and marketing activities, attend the efficient and effective networking of producers and consumers. Marketing channels include the total flows of goods, money and information taking place between the institutions in the system of marketing, establishing a connection between them. The functions of the exchange, the physical supply and service activities, inherent in the system of marketing and trade. They represent paths which products and services are moving after the production, which will ultimately end up buying and eating by the user.

  13. Capacity Markets and Market Stability

    International Nuclear Information System (INIS)

    Stauffer, Hoff

    2006-01-01

    The good news is that market stability can be achieved through a combination of longer-term contracts, auctions for far enough in the future to permit new entry, a capacity management system, and a demand curve. The bad news is that if and when stable capacity markets are designed, the markets may seem to be relatively close to where we started - with integrated resource planning. Market ideologues will find this anathema. (author)

  14. PDE5 inhibitor treatment persistence and adherence in Brazilian men: post-hoc analyses from a 6-month, prospective, observational study.

    Science.gov (United States)

    Cairoli, Carlos; Reyes, Luis Antonio; Henneges, Carsten; Sorsaburu, Sebastian

    2014-01-01

    Characterize persistence and adherence to phosphodiesterase type - 5 inhibitor (PDE5I) on-demand therapy over 6 months among Brazilian men in an observational, non-interventional study of Latin American men naïve to PDE5Is with erectile dysfunction (ED). Men were prescribed PDE5Is per routine clinical practice. Persistence was defined as using ≥ 1 dose during the previous 4 - weeks, and adherence as following dosing instructions for the most recent dose, assessed using the Persistence and Adherence Questionnaire. Other measures included the Self - Esteem and Relationship (SEAR) Questionnaire, and International Index of Erectile Function (IIEF). Multivariate logistic regression was used to identify factors associated with persistence/adherence. 104 Brazilian men were enrolled; mean age by treatment was 53 to 59 years, and most presented with moderate ED (61.7%). The prescribed PDE5I was sildenafil citrate for 50 (48.1%), tadalafil for 36 (34.6%), vardenafil for 15 (14.4%), and lodenafil for 3 patients (2.9%). Overall treatment persistence was 69.2% and adherence was 70.2%; both were numerically higher with tadalafil (75.0%) versus sildenafil or vardenafil (range 60.0% to 68.0%). Potential associations of persistence and/or adherence were observed with education level, ED etiology, employment status, and coronary artery disease. Improvements in all IIEF domain scores, and both SEAR domain scores were observed for all treatments. Study limitations included the observational design, brief duration, dependence on patient self - reporting, and limited sample size. Approximately two-thirds of PDE5I-naive, Brazilian men with ED were treatment persistent and adherent after 6 months. Further study is warranted to improve long-term outcomes of ED treatment.

  15. PDE5 Inhibitor Treatment Persistence and Adherence in Brazilian Men: Post-hoc Analyses from a 6-Month, Prospective, Observational Study

    Directory of Open Access Journals (Sweden)

    Carlos Cairoli

    2014-06-01

    Full Text Available Purpose Characterize persistence and adherence to phosphodiesterase type - 5 inhibitor (PDE5I on-demand therapy over 6 months among Brazilian men in an observational, non-interventional study of Latin American men naïve to PDE5Is with erectile dysfunction (ED. Materials and Methods Men were prescribed PDE5Is per routine clinical practice. Persistence was defined as using ≥ 1 dose during the previous 4 - weeks, and adherence as following dosing instructions for the most recent dose, assessed using the Persistence and Adherence Questionnaire. Other measures included the Self - Esteem and Relationship (SEAR Questionnaire, and International Index of Erectile Function (IIEF. Multivariate logistic regression was used to identify factors associated with persistence/adherence. Results 104 Brazilian men were enrolled; mean age by treatment was 53 to 59 years, and most presented with moderate ED (61.7%. The prescribed PDE5I was sildenafil citrate for 50 (48.1%, tadalafil for 36 (34.6%, vardenafil for 15 (14.4%, and lodenafil for 3 patients (2.9%. Overall treatment persistence was 69.2% and adherence was 70.2%; both were numerically higher with tadalafil (75.0% versus sildenafil or vardenafil (range 60.0% to 68.0%. Potential associations of persistence and/or adherence were observed with education level, ED etiology, employment status, and coronary artery disease. Improvements in all IIEF domain scores, and both SEAR domain scores were observed for all treatments. Study limitations included the observational design, brief duration, dependence on patient self - reporting, and limited sample size. Conclusion Approximately two-thirds of PDE5I-naive, Brazilian men with ED were treatment persistent and adherent after 6 months. Further study is warranted to improve long-term outcomes of ED treatment.

  16. Market formation and market selection

    NARCIS (Netherlands)

    van Raalte, C.L.J.P.

    1996-01-01

    The organization of markets is an important field of inquiry in modern economic theory. This monograph analyzes models which consider the formation and selection of markets. In these models, markets are organized by middlemen and used by traders. In Part I of the monograph, coalitions of middlemen

  17. Market Survey Turkey. Electricity Market

    International Nuclear Information System (INIS)

    2008-12-01

    The present market survey presents the Turkish power market and derives business opportunities and prospects for Dutch trade and industry. This market survey has been carried out for the following four, from time to time overlapping, sectors that have been identified by EVD as potential opportunities for Dutch small and medium-sized enterprises (SME): renewable energy, energy efficiency, electricity generation, electricity distribution

  18. World market of marketing research

    Directory of Open Access Journals (Sweden)

    Samuels John

    2002-01-01

    Full Text Available The value of the total world market market research in the year 2001 was US$15,890 million, a 2.8% increase on the previous year. This is the first of several articles to be published in Research World on the results from ESOMAR's latest annual study on the market research sector worldwide

  19. Integral marketing auditing: Basic features

    Directory of Open Access Journals (Sweden)

    Rakić Mira

    2006-01-01

    Full Text Available Instead of emphasize the "primacy of planning" in management process marketing control should be viewed as an activity that counterbalances marketing planning and strategy, and not as a "post hoc" adjunct to the planning function. Rather, it is a separate marketing function, which by continuously checking on the validity of plans, provides time and flexibility to an organization. Therefore, in this view, marketing planning and control are counterbalances processes which are performed simultaneously. The essence of feedback control is a measurement of the actual and desired states after action has been taken, and a subsequent correction of activities. In feedforward control the activities are corrected by predicting whether current activities would lead to desired states. The single most important reason why feedforward control is different from feedback control is that its use of information is prognostic. While feedback control tries to solve problems that have occurred, feedforward control tries to discover problems waiting to occur. It is also important to distinguish between financial non-financial and multiple control. Financial control of marketing activities involves control of sales revenue, profitability and return on marketing investment (ROMI. Non-financial control of marketing activities consists of control market share, customer satisfaction, customer loyalty, brand equity and customer equity. Key components of multiple control marketing activities are control of efficiency, effectiveness and marketing audit. Marketing performance measures have moved in three consistent directions over the years: from financial to non-financial output measures, from output to input measures and from undimensional to multidimensional measures.

  20. Design for Global Markets

    DEFF Research Database (Denmark)

    Boztepe, Suzan

    2009-01-01

    In a global economy, no company can safely assume that their products will be accepted in foreign markets. One key issue is to understand and meet the latent needs of culturally diverse target markets. This book examines from a user perspective the issue of developing new products for global...... markets. Given that main goal of any design is to create value for users, Boztepe argues that the concept of user value could be a driving force in design decision-making regarding product development for global markets. Through interviews with women about their kitchen practices and observations...... framework to assists marketers, product designers and managers to deal with the complex issue of designing and tailoring products for local needs....

  1. The midstream markets

    International Nuclear Information System (INIS)

    Gurney, J.

    1998-01-01

    Intense activity by wholesale gas marketers and traders now characterises the post-deregulation natural gas industry''s transmission systems, once the sole preserve of powerful interstate pipeline companies. This has meant a shift in power from large companies with massive infrastructure investment to new smaller companies specialising in sophisticated business skills technology utilization. The history underpinning these changes is described in order to clarify the economic changes which have occurred. (UK)

  2. Temporal Evolution of Comet 67P/Churyumov-Gerasimenko Surface Properties as Observed by VIRTIS-M from Pre-Perihelion to Post-Perihelion

    Science.gov (United States)

    Ciarniello, M.; Filacchione, G.; Capaccioni, F.; Raponi, A.; De Sanctis, M. C.; Tosi, F.; Migliorini, A.; Piccioni, G.; Cerroni, P.; Capria, M. T.; Erard, S.; Bockelee-Morvan, D.; Leyrat, C.; Arnold, G.; Barucci, M. A.; Schmitt, B.; Quirico, E.; Fornasier, S.; Kappel, D.; Longobardo, A.; Rousseau, B.; Mottola, S.

    2017-04-01

    Introduction: The Visible and Infrared Thermal Imaging Spectrometer [1] on board the Rosetta spacecraft acquired disk-resolved images of the nucleus of comet 67P/Churyumov-Gerasimenko for more than two years from August 2014 to September 2016. The observation campaigns have been carried out using both the visible (VIS) and infrared (IR) channels of the instrument covering the 0.25-5.1 μm spectral range up to May 2015 and by means of the sole VIS channel (0.25-1 μm) for the remaining part of the mission. This allowed monitoring the spectral properties of the comet surface as a function of the heliocentric distance for the inbound part of the orbit from 3.6 AU to perihelion (1.3 AU) and the outbound part up to 3.3 AU. Throughout this period the surface evolution was further complicated by the combination of the relatively large orbital eccentricity, of the irregular shape of 67P/CG's nucleus and of the inclination of its rotational axis (52° [2]) which amplify the seasonal effects. Method: The long-term variability of 67P's nucleus is described by means of spectral indicators as defined in [3] which are represented by the spectral slopes in the VIS (0.55-0.8 μm) and IR (1.2-2.0 μm) spectral ranges, the single scattering albedo at 0.55 μm [4] and the band area and band center of the 3.2 μm absorption feature [5]. These quantities are computed from photometrically corrected spectra [4], in order to remove observation geometry effects [5]. The spectral indicators are projected onto latitude-longitude maps of the nucleus at different times, in order to monitor both spatial and temporal variations. In parallel, the evolution of selected areas on 67P/CG's surface as selected by [3] is followed to monitor local variability. Preliminary results: The analysis of the VIS slope from observations taken from August 2014 to June 2016, corresponding to the Rosetta mission Medium Term Planning (MTP) observation phases from MTP006 to MTP030, indicates a progressive reduction

  3. Evaluating the functional outcomes of ultrasound-guided botulinum toxin type A injections using the Euro-musculus approach for upper limb spasticity treatment in post-stroke patients; an observational study.

    Science.gov (United States)

    Buyukavci, Raikan; Akturk, Semra; Ersoy, Yüksel

    2018-02-07

    Ultrasound-guided botulinum toxin type A injection is an effective treatment for spasticity. Euro-musculus spasticity approach is a new method for administering injections to the correct point of the correct muscle. The clinical outcomes of this practical approach is not yet available in the literature. The purpose of this study was to evaluate the effects on spasticity and the functional outcomes of ultrasound guided botulinum toxin type A injections via the Euro-musculus spasticity approach to treat upper limb spasticity in post-stroke patients. An observational study. Inpatient post-stroke patients. Twenty five post-stroke patients with post-stroke upper limb spasticity were recruited. The ultrasound-guided botulinum toxin type A injections were administered into the spastic target muscles using the Euro-musculus spasticity approach, and all of the patients were enrolled in rehabilitation programmes after the injections. This research included the innervation zone and injection site figures and ultrasound images of each muscle in the upper limb. The degree of spasticity was assessed via the Modified Ashworth Scale and the upper limb motor function via the Fugl Meyer Upper Extremity Scale at the baseline and 4 and 12 weeks after the botulinum toxin type A injection. Significant decreases in the Modified Ashworth Scale scores of the upper limb flexor muscle tone measured 4 and 12 weeks after the botulinum toxin type A injection were found when compared to the baseline scores (pbotulinum toxin type A injection via the Euro- musculus spasticity approach is a practical and effective method for administering injections to the correct point of the correct muscle. Ultrasound-guided botulinum toxin type A injections combined with rehabilitation programmes decrease spasticity and improve the upper extremity motor functions in stroke patients. This new approach for ultrasound- guided botulinum toxin type A injection is very practical and effective method for upper

  4. Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population: a report from the e-SELECT (Multi-Center Post-Market Surveillance) registry.

    Science.gov (United States)

    Urban, Philip; Abizaid, Alexandre; Banning, Adrian; Bartorelli, Antonio L; Baux, Ana Cebrian; Džavík, Vladimír; Ellis, Stephen; Gao, Runlin; Holmes, David; Jeong, Myung Ho; Legrand, Victor; Neumann, Franz-Josef; Nyakern, Maria; Spaulding, Christian; Worthley, Stephen

    2011-03-29

    The aim of this study was to ascertain the 1-year incidence of stent thrombosis (ST) and major bleeding (MB) in a large, unselected population treated with sirolimus-eluting stents (SES). Stent thrombosis and MB are major potential complications of drug-eluting stent implantation. Their relative incidence and predisposing factors among large populations treated worldwide are unclear. The SES were implanted in 15,147 patients who were entered in a multinational registry. We analyzed the incidence of: 1) definite and probable ST as defined by the Academic Research Consortium; and 2) MB, with the STEEPLE (Safety and efficacy of Enoxaparin in PCI) definition, together with their relation to dual antiplatelet therapy (DAPT) and to 1-year clinical outcomes. The mean age of the sample was 62 ± 11 years, 30.4% were diabetic, 10% had a Charlson comorbidity index ≥3, and 44% presented with acute coronary syndrome or myocardial infarction. At 1 year, the reported compliance with DAPT as recommended by the European Society of Cardiology guidelines was 86.3%. Adverse event rates were: ST 1.0%, MB 1.0%, mortality 1.7%, myocardial infarction 1.9%, and target lesion revascularization 2.3%. Multivariate analysis identified 9 correlates of ST and 4 correlates of MB. Advanced age and a high Charlson index were associated with an increased risk of both ST and MB. After ST, the 7-day and 1-year all-cause mortality was 30% and 35%, respectively, versus 1.5% and 10% after MB. Only 2 of 13,749 patients (0.015%) experienced both MB and ST during the entire 1-year follow-up period. In this worldwide population treated with ≥1 SES, the reported compliance with DAPT was good, and the incidence of ST and MB was low. Stent thrombosis and MB very rarely occurred in the same patient. (The e-SELECT Registry: a Multicenter Post-Market Surveillance; NCT00438919). Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. Balancing the market

    International Nuclear Information System (INIS)

    Steve Kidd

    2007-01-01

    The uranium market still retains arrangements developed in the mists of time, but now is an appropriate time for something new to be developed. Quoted uranium prices continue to move sharply upwards. It can be argued that the long period of price depression followed by such a dramatic spike indicates that the uranium market is not functioning as it really should. Nevertheless, the particular characteristics of the uranium business should ensure that it should arguably have much calmer market conditions. Much of the problem relates to lack of market liquidity and transparency. Prices are published on a weekly and monthly basis by informed observers and are based on information they glean from market participants.The infrastructure issue of much of the nuclear fuel supply business is slowly but surely getting addressed by the required new investment, but the uranium market is still in need of something new.The question then remains about the longer-term market. To some extent, having a more transparent and liquid spot market will go some way towards addressing this. It will undoubtedly take some entrepreneurial leadership to induce this to happen, plus realisation that the current marketplace cannot be in the long-term interest of either buyers or sellers.

  6. Marketization Revisited

    DEFF Research Database (Denmark)

    Hansen, Morten Balle; Lindholst, Andrej Christian

    2016-01-01

    out; Benchmarking and yardstick competition; and Public-Private collaboration. On the basis of the review of the seven articles, it is found that all elements in all marketization models are firmly embedded but also under dynamic change within public service delivery systems. The review also......Purpose: The purpose of this introduction article to the IJPSM special issue on marketization is to clarify the conceptual foundations of marketization as a phenomenon within the public sector and to gauge current marketization trends on the basis of the seven articles in the special issue. Design....../methodology/approach: Conceptual clarification and cross-cutting review of seven articles analysing marketization in six countries in three policy areas at the level of local government. Findings: Four ideal-type models are deduced: Quasi-markets, involving both provider competition and free choice for users; Classic contracting...

  7. Marketing automation

    Directory of Open Access Journals (Sweden)

    TODOR Raluca Dania

    2017-01-01

    Full Text Available The automation of the marketing process seems to be nowadays, the only solution to face the major changes brought by the fast evolution of technology and the continuous increase in supply and demand. In order to achieve the desired marketing results, businessis have to employ digital marketing and communication services. These services are efficient and measurable thanks to the marketing technology used to track, score and implement each campaign. Due to the technical progress, the marketing fragmentation, demand for customized products and services on one side and the need to achieve constructive dialogue with the customers, immediate and flexible response and the necessity to measure the investments and the results on the other side, the classical marketing approached had changed continue to improve substantially.

  8. La Poste

    CERN Multimedia

    2004-01-01

    http://www.cern.ch/cern50/ The French Post Office has issued ten commemorative envelopes bearing original images depicting CERN and its history. This special fiftieth anniversary collector's edition will be available on the French Post Office (« La Poste ») stand at the Open Day on 16 October, in the CMS experiment hall at Cessy. Information for collectors: a pictorial postmark and date stamp have been specially designed and produced for the occasion with the assistance of CERN's graphics team. Sending a philatelic souvenir is a great way to commemorate the Open Day, so La Poste will be setting up a large post-box for that very purpose next to its stand. A perfect way to send images of CERN all around the world...

  9. Understanding Financial Market States Using an Artificial Double Auction Market.

    Science.gov (United States)

    Yim, Kyubin; Oh, Gabjin; Kim, Seunghwan

    2016-01-01

    The ultimate value of theories describing the fundamental mechanisms behind asset prices in financial systems is reflected in the capacity of such theories to understand these systems. Although the models that explain the various states of financial markets offer substantial evidence from the fields of finance, mathematics, and even physics, previous theories that attempt to address the complexities of financial markets in full have been inadequate. We propose an artificial double auction market as an agent-based model to study the origin of complex states in financial markets by characterizing important parameters with an investment strategy that can cover the dynamics of the financial market. The investment strategies of chartist traders in response to new market information should reduce market stability based on the price fluctuations of risky assets. However, fundamentalist traders strategically submit orders based on fundamental value and, thereby stabilize the market. We construct a continuous double auction market and find that the market is controlled by the proportion of chartists, Pc. We show that mimicking the real state of financial markets, which emerges in real financial systems, is given within the range Pc = 0.40 to Pc = 0.85; however, we show that mimicking the efficient market hypothesis state can be generated with values less than Pc = 0.40. In particular, we observe that mimicking a market collapse state is created with values greater than Pc = 0.85, at which point a liquidity shortage occurs, and the phase transition behavior is described at Pc = 0.85.

  10. Sport Marketing

    OpenAIRE

    Ekmekci, Ridvan; Ekmekçi, Aytul Yeter

    2009-01-01

    Abstract  Marketing which is entered to almost our whole life, now more than goods and services, became an important  concept of ideas, persons, institutions, events, and facilities. As a main activities of business co. marketing has an important place in sports industry. Recently, the development of special sport marketing strategies and the presentation of sport goods and services to consumers are gaining importance. Efforts of increasing income of sport clubs, because of sport organization...

  11. Online marketing

    OpenAIRE

    Zrůst, Daniel

    2013-01-01

    The aim of this thesis is to evaluate pay per click marketing as suitable marketing tool for promotion and distribution of a given product. The paper describes basic vocabulary related to PPC advertising, common metrics, tools used by online marketers, and logic of running PPC campaigns. The paper also tries to quantify impact of Internet on economies. The second part applies the theory to analysis of consumers' conversion path while searching online in common search engines where PPC marketi...

  12. Affiliate marketing

    OpenAIRE

    Ureš, Michal

    2012-01-01

    This bachelor's thesis focuses on the topic of online affiliate marketing from the perspective of an internet entrepreneur. In the first, theoretical part, it characterizes the affiliate marketing, describes different, significant affiliate solutions in the Czech market and opportunities for their implementations. In the second, practical part, it concentrates mainly on an affiliate program of a company called GameLeader, s.r.o. It analyses expectations of the business from the implementation...

  13. Power marketing

    International Nuclear Information System (INIS)

    Sioshansi, F.P.; Altman, A.M.

    1998-01-01

    One of the most significant developments in the US electric power industry in recent years has been the phenomenal growth of power marketing. What was barely a blimp on the radar screen in 1992 has turned out to be a jumbo jet. This article explains what is power marketing who are power marketers, what role play these players and what will be their longer-term impact on the traditional industry [it

  14. A New Higher Education Marketing Mix: The 7Ps for MBA Marketing

    Science.gov (United States)

    Ivy, Jonathan

    2008-01-01

    Purpose: The purpose of this paper is to present a new marketing mix based on MBA students' attitudes and opinions towards the marketing initiatives of business schools in South Africa. The post-graduate business education market is, and increasingly, getting more aggressive in their efforts to attract students on to their flagship degree, the…

  15. A Mid-scala Cochlear Implant Electrode Design Achieves a Stable Post-surgical Position in the Cochlea of Patients Over Time-A Prospective Observational Study.

    Science.gov (United States)

    Dees, Guido; Smits, Jeroen Jules; Janssen, A Miranda L; Hof, Janny R; Gazibegovic, Dzemal; Hoof, Marc van; Stokroos, Robert J

    2018-04-01

    Cochlear implant (CI) electrode design impacts the clinical performance of patients. Stability and the occurrence of electrode array migration, which is the postoperative movement of the electrode array, were investigated using a mid-scalar electrode array and postoperative image analysis. A prospective observational study was conducted. A mid-scalar electrode was surgically placed using a mastoidectomy, followed by a posterior tympanotomy and an extended round-window or cochleostomy insertion. A few days after surgery and 3 months later Cone Beam Computed Tomography (CBCT) was performed. The two different CBCT's were fused, and the differences between the electrode positions in three dimensions were calculated (the migration). A migration greater than 0.5 mm was deemed clinically relevant. Fourteen subjects participated. The mid-scalar electrode migrated in one patient (7%). This did not lead to the extrusion of an electrode contact. The mean migration of every individual electrode contact in all patients was 0.36 mm (95% confidence interval 0.22-0.50 mm), which approximates to the estimated measurement error of the CBCT technique. A mid-scalar electrode array achieves a stable position in the cochlea in a small but representative group of patients. The methods applied in this work can be used for providing postoperative feedback for surgeons and for benchmarking electrode designs.

  16. Experiment Observations of the Effects of Fiber Types on the Post-peak Behaviors of Steel Fiber Reinforced Concretes under Tension

    International Nuclear Information System (INIS)

    Cho, Hyun Woo; Moon, Jae Heum; Lee, Jang Hwa; Kang, Su Tae

    2012-01-01

    Concrete is one of the major construction materials that are used to form the containing structures with the function as a radiation barrier for nuclear power plants. While current (steel reinforced) concrete structures for nuclear power plants provide reliable serviceability regarding the requirements of design codes, further safety requirement has been issued with the considerations of the impact of a large, commercial aircraft. U.S. NRC (Nuclear Regulatory Commission) announced the new regulatory code, 10CFR50.150 related to an aircraft impact assessment (AIA). The goal of AIA is to enhance the safety and robustness of new reactor designs at the design stage. To enhance the safety against aircraft impact, two approaches can be simply suggested, increase of barrier wall thickness and/or application of double containment structures. However, these two approaches expect much higher construction costs and much longer building period. Even also, when the thickness of concrete structure is increased, special cares will be expected during the process of concrete placement because of the cracking behavior of mass concrete due to hydration heat. To avoid the pre-described problems and difficulties, strengthening of the concrete properties could be an alternative and the increase of fracture toughness of concrete itself will be the practical approach to enhance the impact resistivity. With this consideration, this research observed the effects of steel fiber reinforcement on the enhancement of fracture toughness for possible future application to nuclear power plant structures

  17. Experiment Observations of the Effects of Fiber Types on the Post-peak Behaviors of Steel Fiber Reinforced Concretes under Tension

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Hyun Woo; Moon, Jae Heum; Lee, Jang Hwa [Korea Institute of Construction Technology, Goyang (Korea, Republic of); Kang, Su Tae [Daegu University, Gyeongsan (Korea, Republic of)

    2012-05-15

    Concrete is one of the major construction materials that are used to form the containing structures with the function as a radiation barrier for nuclear power plants. While current (steel reinforced) concrete structures for nuclear power plants provide reliable serviceability regarding the requirements of design codes, further safety requirement has been issued with the considerations of the impact of a large, commercial aircraft. U.S. NRC (Nuclear Regulatory Commission) announced the new regulatory code, 10CFR50.150 related to an aircraft impact assessment (AIA). The goal of AIA is to enhance the safety and robustness of new reactor designs at the design stage. To enhance the safety against aircraft impact, two approaches can be simply suggested, increase of barrier wall thickness and/or application of double containment structures. However, these two approaches expect much higher construction costs and much longer building period. Even also, when the thickness of concrete structure is increased, special cares will be expected during the process of concrete placement because of the cracking behavior of mass concrete due to hydration heat. To avoid the pre-described problems and difficulties, strengthening of the concrete properties could be an alternative and the increase of fracture toughness of concrete itself will be the practical approach to enhance the impact resistivity. With this consideration, this research observed the effects of steel fiber reinforcement on the enhancement of fracture toughness for possible future application to nuclear power plant structures

  18. Marketing plan

    OpenAIRE

    Jantunen, Essi; Hellman, Annika

    2012-01-01

    The aim of this bachelor’s thesis was to draw up an efficient marketing plan for Pohjolan Vihreä Polku Oy, which offers meeting and nature activity services. The company was in a process of conversion and needed a structured marketing plan. The objectives of the company were perceived through severe research. The main purposes of the marketing plan were to raise the visibility of the company and increase its clientele. The proposed marketing actions are also to be used to improve the company’...

  19. Developing markets?

    DEFF Research Database (Denmark)

    Figueiredo, Bernardo; Chelekis, Jessica; DeBerry-Spence, Benet

    2015-01-01

    acknowledging complex, systemic interdependencies between markets, marketing, and society. Based on a critical review of the meaning of development and an interrogation of various developmental discourses, the authors develop a conceptual framework that brings together issues of development, wellbeing......, and social inequalities. We suggest that these issues are better understooda nd addressed when examined via grounded investigations of the role of markets in shaping the management of resources, consumer agency, power inequalities and ethics. The use of markets as units of analysis may lead to further cross...

  20. Content Analysis of Assessment Data in Marketing Education

    Science.gov (United States)

    Vowles, Nicole; Hutto, Alexandra; Miller, Peter Max M.

    2017-01-01

    This study analyzes a sample of students' writing to assess their understanding of marketing concepts in the context of a Principles of Marketing course. Content analysis of pre- and post-essays was used to assess student knowledge of marketing concepts. The data was collected in Principles of Marketing classes. and highlight that many students…

  1. Spring in the boreal environment: observations on pre- and post-melt energy and CO{sub 2} fluxes in two central Siberian ecosystems

    Energy Technology Data Exchange (ETDEWEB)

    Arneth, A. [Dept. of Physical Geography and Ecosystems Analysis, Lund Univ., Lund (Sweden); Lloyd, J. [Scool of Geography, Leeds Univ., Leeds (United Kingdom); Shibistova, O. [V.N. Sukachev Forest Inst., Akademgorodok, Krasnoyarsk (Russian Federation); Sogachev, A. [Dept. of Physical Sciences, Helsinki Univ. (Finland); Kolle, O. [Max Planck Inst. for Biogeochemistry, Jena (Germany)

    2006-07-01

    A range of observations points towards earlier onset of spring in northern high latitudes. However, despite the profound effects this may have on vegetation-atmosphere exchange of carbon (NEE), vegetation-atmosphere physical coupling, or the location of the tundra-taiga interface, the number of studies that investigate winter-spring transition fluxes in contrasting northern vegetation types is limited. Here, we examine spring ecosystem-atmosphere energy and carbon exchange in a Siberian pine forest and mire. Divergent surface albedo before and during snow-melt resulted in daytime net radiation (R{sub n}) above the forest exceeding R{sub n} above the mire by up to 10 MJ m{sup -2}. Until stomata could open, absorbed radiation by the green pine canopy caused substantial daytime sensible heat fluxes (H > 10MJ m{sup -2}). H above the mire was very low, even negative (< -2 MJ m{sup -2}), during that same period. Physiological activity in both ecosystems responded rapidly to warming temperatures and snow-melt, which is essential for survival in Siberia with its very short summers. On days with above-zero temperatures, before melt was complete, low rates of forest photosynthesis (1-2 {mu}mol m{sup -2} s{sup -1}) were discernible. Forest and mire NEE became negative the same day, or shortly after, photosynthesis commenced. The mire lagged by about two weeks behind the forest and regained its full carbon uptake capacity at a slower rate. Our data provide empirical evidence for the importance the timing of spring and the relative proportion of forest vs. mire has for late winter/spring boundary-layer growth, and production and surface-atmosphere mixing of trace gases. Models that seek to investigate effects of increasingly earlier spring in high latitudes must correctly account for contrasting physical and biogeochemical ecosystem-atmosphere exchange in heterogeneous landscapes. (orig.)

  2. Sexual Markets or Black Markets?

    DEFF Research Database (Denmark)

    Groes-Green, Christian

    2014-01-01

    sex with sugar-daddies, called sponsors or patrons, who provide for them in exchange for sex while male peers often become street vendors, street artists or petty criminals engaged in the so-called ‘black’ markets of theft, sale of counterfeits, and circulation of stolen goods, alcohol and drugs. As I...... show, these gendered markets are highly entangled and interdependent, and as I argue, male and female markets use many of the same technologies, sources and circuits of exchange...

  3. Marketing Management

    DEFF Research Database (Denmark)

    Wilke, Ricky

    2012-01-01

    Book review of: Christian Homburg, Sabine Kuester, Harley Krohmer, Marketing Management – A Contemporary Perspective, McGraw-Hill Higher Education, 2009......Book review of: Christian Homburg, Sabine Kuester, Harley Krohmer, Marketing Management – A Contemporary Perspective, McGraw-Hill Higher Education, 2009...

  4. Market shifting

    Energy Technology Data Exchange (ETDEWEB)

    Forst, Michael

    2013-11-01

    After years of oversupply and artificially low module pricing, market analysts believe that the solar industry will begin to stabilize by 2017. While the market activities are shifting from Europe to the Asia Pacific region and the United States, the solar shakeout continues to be in full swing including solar cell and module manufacturing. (orig.)

  5. Marketing Education

    Science.gov (United States)

    Stancil, Ronald A., Sr.

    2008-01-01

    This article discusses the Marketing Education program at West Haven (CT) High School in West Haven, Connecticut, that promotes skills for life and attributes, enhances the academic program, and develops leaders out of ordinary students through an interactive curriculum. The three components of West Haven's marketing and management program are (1)…

  6. Art Markets

    NARCIS (Netherlands)

    P.A. Arora (Payal); F.R.R. Vermeylen (Filip)

    2013-01-01

    textabstractThe advent of digitization has had a profound impact on the art market and its institutions. In this chapter, we focus on the market for visual arts as it finds its expression in (among other) paintings, prints, drawings, photographs, sculpture and the like. These artistic disciplines

  7. Direct marketing

    Directory of Open Access Journals (Sweden)

    Čičić Muris

    2002-01-01

    Full Text Available Direct Marketing (DM is usually treated as unworthy activity, with actions at the edge of legality and activities minded cheating. Despite obvious problems regarding ethics and privacy threat, DM with its size, importance and role in a concept of integrated marketing communication deserves respect and sufficient analysis and review

  8. Tourism Marketing.

    Science.gov (United States)

    North Carolina State Dept. of Public Instruction, Raleigh. Div. of Vocational Education.

    This document contains teacher materials for a 6-unit, 1-year distributive education course in marketing tourism offered in grades 11 and 12 in North Carolina. Although in general the material presented concerns marketing tourism anywhere, some of it is specifically related to tourism within North Carolina. A purpose statement explains the…

  9. Adding semantics to microblog posts

    NARCIS (Netherlands)

    Meij, E.; Weerkamp, W.; de Rijke, M.

    2012-01-01

    Microblogs have become an important source of information for the purpose of marketing, intelligence, and reputation management. Streams of microblogs are of great value because of their direct and real-time nature. Determining what an individual microblog post is about, however, can be non-trivial

  10. Border markets

    DEFF Research Database (Denmark)

    Walther, Olivier

    2014-01-01

    The objective of this issue of Articulo – Journal of Urban Research is to examine the characteristics of border markets in a comparative perspective. In this introductory paper, I first discuss what makes African border markets different from other markets, and examine several factors that explain...... their unequal economic development: the presence of a trade community, the combination of trading and productive activities, and the relative porosity of borders. In a second part, I examine how border markets on the U.S.-Mexico border must simultaneously guarantee the security of the state while favoring...... regional trade. The last part of the paper argues that more policy attention should be paid to border markets which, despite being at the margin of states, are a vital component of their economy. Fifty years after most West African states became independent and just as NAFTA turns 20, it is high time...

  11. Crossover marketing

    International Nuclear Information System (INIS)

    Heath, D.S.

    1998-01-01

    The impact of a deregulated energy market on customers in Ontario was discussed. In particular, the way in which Sunoco will deal with energy convergence and how Sunoco plans to generate interest among residential consumers in a deregulated and competitive energy market was described. Integrated energy solutions that offer customers value-added heating, ventilating and air conditioning products and services, inclusive of equipment sales, installation, repair, rental, leasing, financing, warranty, insurance and maintenance is the ultimate goal of Sunoco. The major retail issues in the energy market such as licensing of marketers, customer mobility, transfer of utility assets to affiliates, Ontario Hydro's market power in electrical generation, distribution of stranded debt charges, and a timetable for deregulation were also addressed. figs

  12. Agricultura brasileira: uma observação do sub-setor de mercado internoBrazilian agriculture: an observation of the sub-sector of the internal market

    Directory of Open Access Journals (Sweden)

    Hideharu Carlos Ikehara

    1981-11-01

    Full Text Available Análise do sub-setor agrícola de mercado interno, no período 1970/80. Os resultados mostraram que a oferta de culturas de consumo doméstico apresentou crescimento inferior à expansão da demanda de alimentos imposta pelo crescimento demográfico e aumento da renda per capita, com uma performance abaixo daquele observado durante a década de 60, em contraste com o extraordinário desempenho das culturas de mercado externo, consequência de um modelo de desenvolvimento agrícola com nítida direção a estímulos de bens agrícolas com cotação no mercado internacional, trazendo à tona o recrudescimento dos problemas de abastecimento e migração rural-urbam.Analysis of the agricultural subsetor of the internal market in the period 1970-80. The results showed that the supply of products for domestic consumption presented a growth inferior to the expansion of the demand for food imposed by the demographic growth and the rise in income per capita, with a performance lower than that observed during the decade of the 60s, in contrast to the extraordinary behavior of the products in the external market, wich was the consequence of a model for agricultural development with clear definition of stimuli for agricultural goods in the international market, briging into focus the problems of food supply and rural-urban migration.

  13. Biological trade and markets.

    Science.gov (United States)

    Hammerstein, Peter; Noë, Ronald

    2016-02-05

    Cooperation between organisms can often be understood, like trade between merchants, as a mutually beneficial exchange of services, resources or other 'commodities'. Mutual benefits alone, however, are not sufficient to explain the evolution of trade-based cooperation. First, organisms may reject a particular trade if another partner offers a better deal. Second, while human trade often entails binding contracts, non-human trade requires unwritten 'terms of contract' that 'self-stabilize' trade and prevent cheating even if all traders strive to maximize fitness. Whenever trading partners can be chosen, market-like situations arise in nature that biologists studying cooperation need to account for. The mere possibility of exerting partner choice stabilizes many forms of otherwise cheatable trade, induces competition, facilitates the evolution of specialization and often leads to intricate forms of cooperation. We discuss selected examples to illustrate these general points and review basic conceptual approaches that are important in the theory of biological trade and markets. Comparing these approaches with theory in economics, it turns out that conventional models-often called 'Walrasian' markets-are of limited relevance to biology. In contrast, early approaches to trade and markets, as found in the works of Ricardo and Cournot, contain elements of thought that have inspired useful models in biology. For example, the concept of comparative advantage has biological applications in trade, signalling and ecological competition. We also see convergence between post-Walrasian economics and biological markets. For example, both economists and biologists are studying 'principal-agent' problems with principals offering jobs to agents without being sure that the agents will do a proper job. Finally, we show that mating markets have many peculiarities not shared with conventional economic markets. Ideas from economics are useful for biologists studying cooperation but need

  14. Measuring market performance in restructured electricity markets: An empirical analysis of the PJM energy market

    Science.gov (United States)

    Tucker, Russell Jay

    2002-09-01

    Today the electric industry in the U.S. is transitioning to competitive markets for wholesale electricity. Independent system operators (ISOs) now manage broad regional markets for electrical energy in several areas of the U.S. A recent rulemaking by the Federal Energy Regulatory Commission (FERC) encourages the development of regional transmission organizations (RTOs) and restructured competitive wholesale electricity markets nationwide. To date, the transition to competitive wholesale markets has not been easy. The increased reliance on market forces coupled with unusually high electricity demand for some periods have created conditions amenable to market power abuse in many regions throughout the U.S. In the summer of 1999, hot and humid summer conditions in Pennsylvania, New Jersey, Maryland, Delaware, and the District of Columbia pushed peak demand in the PJM Interconnection to record levels. These demand conditions coincided with the introduction of market-based pricing in the wholesale electricity market. Prices for electricity increased on average by 55 percent, and reached the $1,000/MWh range. This study examines the extent to which generator market power raised prices above competitive levels in the PJM Interconnection during the summer of 1999. It simulates hourly market-clearing prices assuming competitive market behavior and compares these prices with observed market prices in computing price markups over the April 1-August 31, 1999 period. The results of the simulation analysis are supported with an examination of actual generator bid data of incumbent generators. Price markups averaged 14.7 percent above expected marginal cost over the 5-month period for all non-transmission-constrained hours. The evidence presented suggests that the June and July monthly markups were strongly influenced by generator market power as price inelastic peak demand approached the electricity generation capacity constraint of the market. While this analysis of the

  15. The Impact of the 2008 Global Financial Crisis on the Structure of the Transmission of Price Innovations Across Financial Markets: The Case of Southwest Asian Equity Markets

    Directory of Open Access Journals (Sweden)

    Liao Qunfeng

    2016-06-01

    Full Text Available This study examines the reaction of Southeast Asian equity markets to the transmission of price innovations from major equity markets during the pre and post periods of the 2008 global financial crisis. In particular, we examine the reaction of returns indices in Malaysia, the Philippines, South Korea, Taiwan, and Thailand as endogenous variables, and compare them to the returns indices of the U.S., the Eurozone, Japan, and China as exogenous variables. The results of VAR models indicate the combined and individual impact of the price innovations from the major equity markets on the volatility of returns of selected countries is relatively trivial during either the pre- or post-financial crisis periods. However, the individual impact of the U.S. innovations is generally higher during the post-financial crisis. The ARCH and GARCH models indicate the stock markets of Southeast Asian countries are more responsive to their own price innovations during both the pre- and the post-crisis periods, although some response to U.S. and Eurozone shocks is also observed.

  16. Marketing is Dead! Long Live Marketing!

    OpenAIRE

    Marjanova Jovanov, Tamara

    2016-01-01

    The contents of the lectures included: Why marketing? Citizen, Consumer, Customer (Behavior) Who is the Father of Marketing? Some Antecedents of Marketing When Did Marketing Start? The Contributors of Marketing Where Did Marketing Start? Job Positions in Today’s Marketing Organization The Role of the Chief Marketing Officer Four Different CEO Views of Marketing Reality – Truth – Challenge (Why Can’t We Make It?) The Strong and Steady Progress of Marketi...

  17. Post-pneumonectomy empyema and dosimetric CT scan. Report of two cases and review of literature; Empyeme thoracique postpneumonectomie et scanographie dosimetrique. A propos de deux observations et revue de la litterature

    Energy Technology Data Exchange (ETDEWEB)

    Latorzeff, I.; Bachaud, J.M.; Aziza, R.; Arboucalot, F. [Centre Claudius-Regaud, 31 - Toulouse (France); Berjaud, J.; Dahan, M.; Giron, J. [Centre Hospitalier Universitaire Purpan, 31 - Toulouse (France)

    1999-12-01

    Following a pneumonectomy for cancer, the patients are classically observed by clinical examination and standard chest X-ray. However, torpid empyemas can be missed when they occur after the period of hospitalization and when they are not accompanied by a fever, At the time of postoperative radiotherapy, the dosimetric CT scan constitutes the first examination providing objective information of the endo-thoracic content. It is therefore necessary on this occasion to assure the normality of the post-pneumonectomy pleural space while checking that the substituted liquid is homogeneous and above all that the internal mediastinal part of the cavity has a concave appearance. If that is not the case, an empyema should be suspected. The diagnosis, confirmed by a cyto-bacteriological examination of the pleural fluid, constitutes a counter-indication of the radiotherapy. We present two cases of post-pneumonectomy pauci-symptomatic empyema which were diagnosed during the course of postoperative radiotherapy when the initial dosimetric CT scan was pathologic and could have allowed an earlier diagnosis. (author)

  18. Market segmentation: Venezuelan ADRs

    Directory of Open Access Journals (Sweden)

    Urbi Garay

    2012-12-01

    Full Text Available The control on foreign exchange imposed by Venezuela in 2003 constitute a natural experiment that allows researchers to observe the effects of exchange controls on stock market segmentation. This paper provides empirical evidence that although the Venezuelan capital market as a whole was highly segmented before the controls were imposed, the shares in the firm CANTV were, through their American Depositary Receipts (ADRs, partially integrated with the global market. Following the imposition of the exchange controls this integration was lost. Research also documents the spectacular and apparently contradictory rise experienced by the Caracas Stock Exchange during the serious economic crisis of 2003. It is argued that, as it happened in Argentina in 2002, the rise in share prices occurred because the depreciation of the Bolívar in the parallel currency market increased the local price of the stocks that had associated ADRs, which were negotiated in dollars.

  19. Mobile Marketing

    OpenAIRE

    Luengo Cascudo, Alberto

    2010-01-01

    El principal objetivo de este proyecto es explicar y entender la importancia del Mobile Marketing como nueva herramienta de negocio en el Marketing empresarial. Para ello, el primer objetivo es entender los dos factores que para mí son la clave de su importancia: la evolución del entorno tecnológico y el cambio en los hábitos del consumidor. Debido a la novedad de esta nueva forma de Marketing y al hecho de que está en constante definición, es básico exponer de la forma más cla...

  20. Mobile Marketing

    OpenAIRE

    竹安, 数博; Takeyasu, Kazuhiro

    2005-01-01

    This article deals with one of the modern trends in marketing communication, which is mobile marketing. Towards the end of 2008, several projects which use mobile phones for target marketing communication were launched. Commercial SMS´s are sent on the base of agreement or registration of the consumers on special websites, for example hellomobil.cz. The benefit for the consumers is the bonus which can have more forms - not only sending money to the account, free SMS´s/MMS´s and minutes but al...

  1. MARKET WATCH

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    TO THE POINT:The government vows to control the real estate market after a year of robust growth.To diversify financial investment tools,the regulatory authorities approved the launch of stock index futures,and short selling and margin trading to allow investors to hedge against risks.China overtakes the United States to become the world’s biggest auto market in2009.The country is also expected to become the largest consumer market in the world by2020.Google threatens to halt its China operations if it cannot reach a censorship agreement with the government.

  2. Uranium market

    International Nuclear Information System (INIS)

    Rubini, L.A.; Asem, M.A.D.

    1990-01-01

    The historical development of the uranium market is present in two periods: The initial period 1947-1970 and from 1970 onwards, with the establishment of a commercial market. The world uranium requirements are derived from the corresponding forecast of nuclear generating capacity, with, particular emphasis to the brazilian requirements. The forecast of uranium production until the year 2000 is presented considering existing inventories and the already committed demand. The balance between production and requirements is analysed. Finally the types of contracts currently being used and the development of uranium prices in the world market are considered. (author)

  3. MARKET WATCH

    Institute of Scientific and Technical Information of China (English)

    2009-01-01

    China vows to keep a stringent handle on the industrial overcapacity that is draining life from the economic revival. China Mobile pushes forward OPhone and its operating system in an aggressive push into the 3G market. As its tight grip over the market slips, the wireless titan cannot wait to regain lost ground. China’s manufacturing sector continues to pick up steam as evidenced by the climbing PMI. Soaring prices of pork and eggs reignite fears over inflation. The buoyant real estate market appears to be nearing a turning point as sales cool down.

  4. [Ceramic posts].

    Science.gov (United States)

    Mainjot, Amélie; Legros, Caroline; Vanheusden, Alain

    2006-01-01

    As a result of ceramics and all-ceram technologies development esthetic inlay core and abutments flooded the market. Their tooth-colored appearance enhances restoration biomimetism principally on the marginal gingiva area. This article reviews indications and types of cores designed for natural teeth and implants.

  5. Observational therapeutics: Scope, challenges, and organization.

    Science.gov (United States)

    Vaidya, Rama

    2011-10-01

    The importance of Observational Therapeutics in the progress of medicine has been neglected in the current era of the hierarchal position imparted to Randomized Controlled Trials (RCTs) for new drug discovery and practice of evidence-based medicine. There is a need to reflect on the reason for many new drugs being withdrawn during post marketing surveillance. There are several examples in literature where drug-discovery has originated initially from keen clinical and / or laboratory observations. The roots of these discoveries have often been from observations made by practitioners of traditional medicine including Ayurveda. The present article draws attention to the scope and challenges for observational therapeutics. There is an urgent need for the meticulous planning for a systematic organization of developing observational therapeutics, with a full understanding of its strengths and limitations.

  6. Observational therapeutics: Scope, challenges, and organization

    Directory of Open Access Journals (Sweden)

    Rama Vaidya

    2011-01-01

    Full Text Available The importance of Observational Therapeutics in the progress of medicine has been neglected in the current era of the hierarchal position imparted to Randomized Controlled Trials (RCTs for new drug discovery and practice of evidence-based medicine. There is a need to reflect on the reason for many new drugs being withdrawn during post marketing surveillance. There are several examples in literature where drug-discovery has originated initially from keen clinical and / or laboratory observations. The roots of these discoveries have often been from observations made by practitioners of traditional medicine including Ayurveda. The present article draws attention to the scope and challenges for observational therapeutics. There is an urgent need for the meticulous planning for a systematic organization of developing observational therapeutics, with a full understanding of its strengths and limitations.

  7. Liquidity and Impact in Fair Markets

    OpenAIRE

    Jaisson, Thibault

    2015-01-01

    We develop a theory which applies to any market dynamics that satisfy a fair market assumption on the nullity of the average profit of simple market making strategies. We show that for any such fair market, there exists a martingale fair price which corresponds to the average liquidation value (at the ask or the bid) of an infinitesimal quantity of stock. We show that this fair price is a natural reference price to compute the ex post gain of limit orders. Using only the fair market assumptio...

  8. Strategic market approach for entering the Indian solar water pump market : plan the marketing strategy for solar off-grid applications

    OpenAIRE

    Almanasreh, Khalil

    2011-01-01

    This study examines the strategic market approach for investing in solar water pumps market (SWP) in India, and Punjab state as a business case. The main research question is: What is an appropriate strategic market approach to invest in solar water pump market in India? The study focuses on the marketing strategy and strategic planning to enter the Indian market. The thesis follows the qualitative study design where the data was collected by observing the market and interviewing main sta...

  9. Mobile marketing

    OpenAIRE

    Gause, Matěj

    2012-01-01

    The goal of bachelor's thesis on the theme "Mobile marketing" is to outline its development and why is this new phenomen so important for all modern companies around the world. The work is not about simple description of mobile marketing media but it vividly informs about the latest trends and news from the world of mobile apps and games. It presents the most successful mobile apps which registered more than billion downloads and from their unique characteristics it unveils great potential of...

  10. MARKET WATCH

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    China’s manufacturing activities keep slowing down.The"big four"state-owned commercial banks have reaped juicy profits,though capital adequacy remains a concern.In striking contrast,the steelmakers are struggling to make ends meet as costs inflation erodes profit margins.The consumer market booms as usual during the May Day holiday.The search engine Baidu benefits from torrid traffic growth and a diversified market strategy.

  11. Entrepreneurial Marketing

    OpenAIRE

    Gruber, Marc

    2004-01-01

    Entrepreneurship is one of the youngest disciplines in the area of business administration. Hence, there is a special need for literature that can be used in teaching and that can serve as a basis for research. This article reviews five textbooks and three research-oriented books on entrepreneurial marketing, which is regarded as one of the key areas of entrepreneurship. As the review shows, there is no textbook that covers all relevant aspects of entrepreneurial marketing in sufficient bread...

  12. MARKET WATCH

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    The manufacturing industry shows signs of recovery as reflected by a rebounding PMI. The initial public offerings market withers due to less than favorable stock markets. Chinese shipbuilders reel from decreasing orders as external demands falter. The mobile payment industry bursts with vitality, though the security issue remains an acute concern. Foreign banks in China lag behind their local competitors in terms of profitability owing to limited ability to attract deposits.

  13. Market scope

    International Nuclear Information System (INIS)

    2002-01-01

    Nova Scotia's Energy Strategy is aimed at opening the electricity market to wholesale competition, allowing eligible wholesale customers (such as municipal distribution utilities) to buy their electricity from competitive sources. The Nova Scotia Electricity Marketplace Governance Committee (EMGC) is concerned that this will not promote long-term competition because these eligible customers form only a very small fraction (1.6 per cent) of the total electricity demand in the province. This report examines the possible extensions of competition beyond the minimum specified in the Energy Strategy. It also identifies approaches that the EMGC may consider, including other potential levels of competition and their associated issues. The report discussed the issue of implementing wholesale competition as it relates to unbundling of the transmission tariff from the cost of energy supply and from the cost of distribution in retail marketing. The stages of expanding the market scope were also described with reference to large industrial customers, medium industrial and large commercial customers, and small commercial and residential customers. The report states that it is unlikely that the transition to an open access transmission market will need to be reversed, as it is likely to be an essential component of any further development. The EMGC feels it could minimize future transition costs and promote future evolution of competition by recommending for an institutional and market structure that is compatible with a broader competitive market

  14. Marketing Particularities in Tourism and Services

    OpenAIRE

    Anca Gabriela Turtureanu

    2007-01-01

    The marketing has as an essential objective the orientation of firms’ activities based on the market needs. This presupposes, necessarily, the existence of an informational system very well established, that observes any rapid changing market environment: the consumer, distributor and competition. Marketing services is a marketing specialized domain, autonomous, clearly differentiated, in the process of consolidation and development. The services characteristics such as: immateriality, insepa...

  15. Development trends of the international derivatives market

    OpenAIRE

    Motorniuk, U.; Terebukh, M.; Kharchuk, V.

    2016-01-01

    The factors forming international derivatives market trends are researched in this article. The history of the formation of the global derivatives market was analyzed, in particular, events which have led to the growth of the derivatives market. Global derivatives market has revealed major changes in its trends and witnessed the gradual transformation of its structure, observed in recent years. Global derivatives market has revealed major changes in its trends and witnessed the gradual transf...

  16. A CLASSIC FRAMEWORK OF ONLINE MARKETING TOOLS

    OpenAIRE

    Popa Adela Laura

    2015-01-01

    The present paper starts from the assumption that there is a tendency, especially among practitioners, to largely overlap concepts of online marketing and online advertising, thus considering that most online marketing tools aim at the aspect of value communication and promotion. This observation prompted us to try to delineate the categories of online marketing tools according to the traditional areas of marketing activity. Therefore, the paper aims to present the online marketing tools base...

  17. Pseudo market timing : A reappraisal

    NARCIS (Netherlands)

    Dahlquist, M.; de Jong, F.C.J.M.

    2008-01-01

    The average firm going public or issuing new equity underperforms the market in the long run. This underperformance could be related to the endogeneity of the number of new issues if new issues cluster after periods of high abnormal returns on new issues. In such a case, ex post measures of new

  18. Traditional marketing vs. Internet marketing. A comparison

    OpenAIRE

    Varfan, Mona; Shima, Alfa

    2008-01-01

    Title: Traditional marketing vs. Internet marketing: A comparison Problem: Marketing is an important strategy for businesses and it contains numerous effective tools. Traditional marketing has been in use for many years and nowadays Internet has brought new ways of doing business for companies and that has affected marketing. What are the main differences between Internet marketing and traditional marketing? Which one of the two approaches contains the most used and effective marketing tools ...

  19. Monitoring post

    DEFF Research Database (Denmark)

    Hansen, Pelle Guldborg; Jespersen, Andreas Maaløe

    2013-01-01

    This blog reports on the rumour that White House considers establishing a nudge unit similar to the UK Behavioural Insights Team. Given The Nudging Networks purpose and the work of the iNudgeYou-team this post is updated continuously to follow the US debate as it unfolds. Which issues are raised...

  20. Market Development of Video Games : Video game markets and marketing

    OpenAIRE

    Pu, Jun

    2010-01-01

    This diploma work focus on analysing the markets and marketing of video game industry. After the research of this study, I found out that console game markets are growing dramatically in the recent years. On the other hand, PC game markets (excluding online game markets) are growing slowly due to the problem of illegal copies. So my study will then focus on the development of console game markets and marketing. A new concept called Three Parties is introduced in chapter 5 to help ...