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Sample records for post-marketing clinical study

  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. 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

  3. [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.

  4. [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.

  5. [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.

  6. [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.

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

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    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. 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.

  11. [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.

  12. [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.

  13. [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.

  14. 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

  15. 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

  16. [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.

  17. [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.

  18. 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.

  19. 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.

  20. 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.

  1. [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.

  2. Marketing and clinical trials: a case study.

    Science.gov (United States)

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-11-20

    Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  3. 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.

  4. Marketing and clinical trials: a case study

    Directory of Open Access Journals (Sweden)

    Entwistle Vikki A

    2007-11-01

    Full Text Available Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  5. 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).

  6. [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.

  7. [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.

  8. ["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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. [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.

  15. 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

  16. 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)

  17. 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.

  18. 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.

  19. 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

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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...

  8. 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.

  9. Bulls and bears: the stock market and clinical pathology research.

    Science.gov (United States)

    Khong, T Y

    2009-09-01

    To analyse the level of funded research in clinical pathology in a recent bear and bull market to act as a predictor for future funding during the current global financial crisis. The level of funding for research published in three clinical pathology journals in 2005 and 2008 to coincide with the bear market of March 2000 to October 2002 and with the subsequent bull market to October 2007 was determined using a Medline query. Other parameters examined were the type of article, affiliation of the first author and the pathology subspecialty. Approximately 30% of publications were funded and did not differ between the 2 years studied. Original research papers were more likely to be funded than case reports or reviews. Research from university departments of pathology was more likely to be funded than from hospital pathology departments but there were more publications from hospital pathology departments. The proportion of research in the different subspecialties that was funded did not differ significantly between each other and between 2005 and 2008. Based on data from the previous bear market, which was the longest and deepest of the post 1950 era, and the subsequent bull market, which led to the all-time high in the Dow Jones Industrial Index, funding for clinical pathology research does not seem to be affected by bull or bear markets.

  10. 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.

  11. [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.

  12. 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.

  13. [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.

  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. [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.

  16. [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.

  17. 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.

  18. Marketing and clinical trials: a case study

    OpenAIRE

    Entwistle Vikki A; Snowdon Claire; Garcia Jo; Knight Rosemary C; Shakur Haleema; Elbourne Diana R; Roberts Ian; Francis David; McDonald Alison M; Grant Adrian M; Campbell Marion K

    2007-01-01

    Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, o...

  19. [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.

  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. [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. 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.

  3. [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.

  4. [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.

  5. Defining post-sternotomy mediastinitis for clinical evidence-based studies.

    Science.gov (United States)

    van Wingerden, Jan J; de Mol, Bas A J M; van der Horst, Chantal M A M

    2016-05-01

    Considerable advances have already been made in the treatment of deep thoracic wound infections following a median sternotomy for cardiac surgery. Further improvement in diagnosis, treatment, and outcome will require a targeted approach by multidisciplinary teams. Clear communication and synergy between the various clinical and supportive disciplines would assist in removing the last barriers to standardized evidence-based studies and the development of improved evidence-based guidelines. An extensive literature search without language restrictions was carried out on PubMed (Medline), EMBASE, and Web of Science, covering the period 1988 to week 16, 2014, and a manual search of the reference lists was performed regarding all possible definitions and classifications of post-sternotomy mediastinitis. Two hundred and eighteen papers describing post-sternotomy infections in a multitude of terms were identified, and the strengths and weaknesses of the most popular definitions and terms relating specifically to post-sternotomy infections were examined. This study revealed that clinicians use a multitude of terms to describe post-sternotomy infections without defining the condition under treatment. Occasionally, older epidemiological (surveillance) definitions were used. It also shows that supportive disciplines have their own definitions, or interpretations of existing definitions, to describe these infections. The outcome of this study is that clinicians have adopted no single definition, which is essential for further improvement for evidence-based studies. We suggest that it is possible to adopt a single term for thoracic infection after a sternotomy (and only sternotomy), and propose a clinical definition for this purpose. © The Author(s) 2016.

  6. 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.

  7. 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.

  8. 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.

  9. Prediction of black box warning by mining patterns of Convergent Focus Shift in clinical trial study populations using linked public data.

    Science.gov (United States)

    Ma, Handong; Weng, Chunhua

    2016-04-01

    To link public data resources for predicting post-marketing drug safety label changes by analyzing the Convergent Focus Shift patterns among drug testing trials. We identified 256 top-selling prescription drugs between 2003 and 2013 and divided them into 83 BBW drugs (drugs with at least one black box warning label) and 173 ROBUST drugs (drugs without any black box warning label) based on their FDA black box warning (BBW) records. We retrieved 7499 clinical trials that each had at least one of these drugs for intervention from the ClinicalTrials.gov. We stratified all the trials by pre-marketing or post-marketing status, study phase, and study start date. For each trial, we retrieved drug and disease concepts from clinical trial summaries to model its study population using medParser and SNOMED-CT. Convergent Focus Shift (CFS) pattern was calculated and used to assess the temporal changes in study populations from pre-marketing to post-marketing trials for each drug. Then we selected 68 candidate drugs, 18 with BBW warning and 50 without, that each had at least nine pre-marketing trials and nine post-marketing trials for predictive modeling. A random forest predictive model was developed to predict BBW acquisition incidents based on CFS patterns among these drugs. Pre- and post-marketing trials of BBW and ROBUST drugs were compared to look for their differences in CFS patterns. Among the 18 BBW drugs, we consistently observed that the post-marketing trials focused more on recruiting patients with medical conditions previously unconsidered in the pre-marketing trials. In contrast, among the 50 ROBUST drugs, the post-marketing trials involved a variety of medications for testing their associations with target intervention(s). We found it feasible to predict BBW acquisitions using different CFS patterns between the two groups of drugs. Our random forest predictor achieved an AUC of 0.77. We also demonstrated the feasibility of the predictor for identifying long

  10. [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.

  11. 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.

  12. 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.

  13. 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.

  14. A marketing clinical doctorate programs.

    Science.gov (United States)

    Montoya, Isaac D; Kimball, Olive M

    2007-01-01

    Over the past decade, clinical doctorate programs in health disciplines have proliferated amid both support and controversy among educators, professional organizations, practitioners, administrators, and third-party payers. Supporters argue that the explosion of new knowledge and increasing sophistication of technology have created a need for advanced practice models to enhance patient care and safety and to reduce costs. Critics argue that necessary technological advances can be incorporated into existing programs and believe that clinical doctorates will increase health care costs, not reduce them. Despite the controversy, many health disciplines have advanced the clinical doctorate (the most recent is the doctor of nursing practice in 2004), with some professions mandating the doctorate as the entry-level degree (i.e., psychology, pharmacy, audiology, and so on). One aspect of the introduction of clinical doctoral degrees has been largely overlooked, and that is the marketing aspect. Because of marketing considerations, some clinical doctorates have been more successfully implemented and accepted than others. Marketing is composed of variables commonly known as "the four P's of marketing": product, price, promotion, and place. This report explores these four P's within the context of clinical doctorates in the health disciplines.

  15. 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…

  16. 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.

  17. [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.

  18. 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.

  19. 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…

  20. 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

  1. Clinical evaluation of marketed orthodontic products: are researchers behind the times? A meta-epidemiological study

    Directory of Open Access Journals (Sweden)

    Jadbinder Seehra

    2017-05-01

    Full Text Available Abstract Background The role of marketing and industry in the treatment decisions of orthodontists has received increasing attention in recent years with clinical research typically undertaken subsequent to established use of these devices and often failing to confirm the promise of manufacturers’ claims. This meta-epidemiological study was undertaken to assess the proportion of clinical trials in orthodontics evaluating commercially marketed products and to evaluate the direction of the results of these studies. Methods Electronic searching was undertaken to identify randomized controlled trials (RCTs published over a 5-year period (1 January 2012 to 31 December 2016. Data obtained included the type of marketed intervention, direction of effect and declaration of both industry sponsorship and conflict of interest. Results Eighty-four RCTs published in 23 scientific journals were included with the highest percentage in the American Journal of Dentofacial Orthopedics (AJO-DO (23.8%, followed by the European Journal of Orthodontics (EJO (14.3%, Journal of Orthodontics (JO (10.7% and Angle Orthodontist (AO (10.7%. Overall, 45% (38/84 of clinical trials assessed involved analysis of marketed products after their introduction. Interventions to improve oral health or circumvent the risk of iatrogenic damage, such as white spot lesions, were most commonly assessed (15.8%, with the relative merits of non-surgical adjuncts (14.1% and other orthodontic auxiliaries (13.1% also frequently evaluated. In 44% of RCTs, a positive effect of the marketed intervention was not reported. Industry sponsorship of the research was declared in 9.5% RCTs. No significant associations between the direction of the effect and both declaration of industry sponsorship (p = 0.56 and conflict of interest (p = 0.96 were detected. Moreover, for marketed and non-marketed products, no significant associations for both declaration of industry sponsorship (p = 0.44 and

  2. 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)

  3. 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)

  4. [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

    concealment of random numbers, 5% used placebo, 10% reported outcome attrition bias and no study employed the analysis of intention-to-treat and 98% reported the diagnostic criteria for type 2 diabetes. The participants mainly consisted of outpatients without complications (76%). The minimum and maximum sample size was 40 and 300 (106 ± 60), respectively. The inclusion and exclusion criteria and outcome measures did not match the purposes and contents of post-marketing research in the included studies. They also failed to reflect the basic principles of traditional Chinese medicine in the process of diagnosis and treatment. The demographic characteristics of the patients, the indications for medicine and the syndrome differentiation process were not reported sufficiently and transparently. In order to improve the post-marketing research and promote the rational use of Chinese patent drugs, it is recommended that phase IV clinical trials should establish clear research purpose as well as hypothesis first, and choose scientific and evidence-based study design and outcome measures. In addition, guidelines for implementation of post-marketing research should be developed.

  5. 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.

  6. What is the optimum social marketing mix to market energy conservation behaviour: an empirical study.

    Science.gov (United States)

    Sheau-Ting, Low; Mohammed, Abdul Hakim; Weng-Wai, Choong

    2013-12-15

    This study attempts to identify the optimum social marketing mix for marketing energy conservation behaviour to students in Malaysian universities. A total of 2000 students from 5 major Malaysian universities were invited to provide their preferred social marketing mix. A choice-based conjoint analysis identified a mix of five social marketing attributes to promote energy conservation behaviour; the mix is comprised of the attributes of Product, Price, Place, Promotion, and Post-purchase Maintenance. Each attribute of the mix is associated with a list of strategies. The Product and Post-purchase Maintenance attributes were identified by students as the highest priority attributes in the social marketing mix for energy conservation behaviour marketing, with shares of 27.12% and 27.02%, respectively. The least preferred attribute in the mix is Promotion, with a share of 11.59%. This study proposes an optimal social marketing mix to university management when making decisions about marketing energy conservation behaviour to students, who are the primary energy consumers in the campus. Additionally, this study will assist university management to efficiently allocate scarce resources in fulfilling its social responsibility and to overcome marketing shortcomings by selecting the right marketing mix. Copyright © 2013 Elsevier Ltd. All rights reserved.

  7. 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)

  8. Clinical trials in "emerging markets": regulatory considerations and other factors.

    Science.gov (United States)

    Singh, Romi; Wang, Ouhong

    2013-11-01

    Clinical studies are being placed in emerging markets as part of global drug development programs to access large pool of eligible patients and to benefit from a cost effective structure. However, over the last few years, the definition of "emerging markets" is being revisited, especially from a regulatory perspective. For purposes of this article, countries outside US, EU and the traditional "western countries" are discussed. Multiple factors are considered for placement of clinical studies such as adherence to Good Clinical Practice (GCP), medical infrastructure & standard of care, number of eligible patients, etc. This article also discusses other quantitative factors such as country's GDP, patent applications, healthcare expenditure, healthcare infrastructure, corruption, innovation, etc. These different factors and indexes are correlated to the number of clinical studies ongoing in the "emerging markets". R&D, healthcare expenditure, technology infrastructure, transparency, and level of innovation, show a significant correlation with the number of clinical trials being conducted in these countries. This is the first analysis of its kind to evaluate and correlate the various other factors to the number of clinical studies in a country. © 2013.

  9. 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

  10. [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.

  11. 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,

  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. International market research at the Mayo Clinic.

    Science.gov (United States)

    Hathaway, M; Seltman, K

    2001-01-01

    Mayo Clinic has a long international history and has been providing care to international patients since its inception. Despite its history and reputation, however, the marketing staff continues to monitor the international market to gauge the level of awareness, reputation, and attractiveness of Mayo Clinic around the world. Here's a look at how one institution has used word-of-mouth marketing to maintain its global reputation.

  14. 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

  15. 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.

  16. 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)

  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. Efficiency of Calatonia on clinical parameters in the immediate post-surgery period: a clinical study

    Directory of Open Access Journals (Sweden)

    Elaine Ferreira Lasaponari

    2013-09-01

    Full Text Available OBJECTIVE: to assess the efficiency of the Calatonia technique about clinical parameters and pain in the immediate post-surgical phase. METHOD: a randomised study was carried out with 116 patients subjected to a cholecystectomy, by laparoscopy, divided into an experimental group (58 patients and a placebo group (58 patients. The experimental group received the Calatonia technique, while the placebo was only subjected to non-intentional touches. RESULTS: The placebo group and the experimental group were considered homogeneous in terms of the variables: sex, age, physical status classification, duration of surgical procedures and also the time spent recovering in the Post-Anaesthetic Recovery Room. The only variable to show a statistically significant difference was the axillary temperature of the body. In relation to pain, the experimental group showed significant results, and hence it is possible to deduce that the relaxation caused by the Calatonia technique brought some relief of the general situation of pain. CONCLUSION: The application of Calatonia can take up the function of a resource complementary to assistance in the period immediately after surgery. Brazilian Register of Clinical Trials, UTN U1111-1129-9629.

  19. 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

  20. 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

  1. 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....

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. Clinical Outcomes of Zirconium-Oxide Posts: Up-to-Date Systematic Review.

    Science.gov (United States)

    Al-Thobity, Ahmad M

    2016-06-01

    The aim of this systematic review was to investigate the clinical outcomes of the use of zirconium-oxide posts in the past 20 years. The addressed question was: Do zirconium-oxide posts maintain the long-term survival rate of endodontically treated teeth? A database search was made of articles from January 1995 to December 2014; it included combinations of the following keywords: "zirconia," "zirconium oxide," "dowel/dowels," "post/posts," and "post and core." Exclusion criteria included review articles, experimental studies, case reports, commentaries, and articles published in a language other than English. Articles were reviewed by the titles, followed by the abstracts, and, finally, the full text of the selected studies. Four studies were included after filtering the selected studies according to the inclusion and exclusion criteria. In one study, the prefabricated zirconia posts with indirect glass-ceramic cores had significantly higher failure rates than other posts with direct composite cores. In two studies, no failure of the cemented posts was observed throughout the follow-up period. Due to the limited number of clinical studies, it can be concluded that the long-term success rate of prefabricated zirconium-oxide posts is unclear.

  7. 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.

  8. 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.

  9. 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.

  10. CLINICAL STUDY OF POST LAPAROTOMY WOUND DEHISCENCE

    Directory of Open Access Journals (Sweden)

    Chanda Ramanachalam

    2017-04-01

    Full Text Available BACKGROUND The aim of the study is to- 1. Assess the association and prevalence of risk factors involved in causing post laparotomy wound dehiscence. 2. Identify the type of disease involved in causing abdominal wound dehiscence. 3. Effectively manage cases of wound dehiscence. MATERIALS AND METHODS Total 50 cases clinically presenting as gaping of abdominal wound and discharge from the site during the period of October 2014 to April 2016 were taken for study. Patients presenting with abdominal wound dehiscence after undergoing elective or emergency operation Each case was examined clinically and properly in systematic manner and an elaborative study of history based on chief complaints, significant risk factors, investigations, time and type of surgery performed and postoperative events and day of onset of wound dehiscence. RESULTS Males outnumbered females with 64% males and 36% females. Patients in the age group of 41-50 years and 51-60 years found to have highest incidence of abdominal wound dehiscence. Mean age of the patients affected was 48.02 years. Incidence of abdominal wound dehiscence is more common in patients with peritonitis due to duodenal and appendicular perforation than in case of intestinal obstruction. Incidence of abdominal wound dehiscence is more common in patients who are operated in emergency than elective (35:15. Surgical procedures, which included perforation closure carried higher incidence of wound dehiscence. Patients operated with midline incision carried higher risk for wound dehiscence than those operated with paramedian incisions. Incidence of abdominal wound dehiscence is more common in patients having their BMI >25 and anaemia (Hb% <10 g%. Average stay was 22 days, which increased both economic burden on patient and hospital. Out of 50 cases, 48 survivals and 2 were mortals. Partial wound dehiscence was conservative management, i.e. healing by secondary intention was observed in 32 patients and 8 patients had

  11. Clinical communication in diagnostic imaging studies: mixed-method study of pre- and post-implementation of a hospital information system.

    Science.gov (United States)

    Pirnejad, H; Niazkhani, Z; Bal, R

    2013-01-01

    To examine how and why the quality of clinical communication between radiologists and referring physicians was changed in the inpatient imaging process after implementation of a hospital information system (HIS). A mixed-method study of the chest X-ray (CXR) requests and reports, and their involved processes within a pre- and post-HIS implementation setting. Documentation of patient age, patient ward, and name and signature of requesting physician decreased significantly in post-HIS CXR requests (Pcommunication loop between physicians and radiologists after the implementation resulted in extra steps in the workflow and more workload for them. To cope with the new workload, they adopted different workarounds that could explain the results seen in the quantitative study. The HIS improved communication of administrative and identification information but did not improve communication of clinically relevant information. The reason was traced to the complications that the inappropriate implementation of the system brought to clinical workflow and communication loop.

  12. Stock market returns and clinical trial results of investigational compounds: an event study analysis of large biopharmaceutical companies.

    Science.gov (United States)

    Hwang, Thomas J

    2013-01-01

    For biopharmaceutical companies, investments in research and development are risky, and the results from clinical trials are key inflection points in the process. Few studies have explored how and to what extent the public equity market values clinical trial results. Our study dataset matched announcements of clinical trial results for investigational compounds from January 2011 to May 2013 with daily stock market returns of large United States-listed pharmaceutical and biotechnology companies. Event study methodology was used to examine the relationship between clinical research events and changes in stock returns. We identified public announcements for clinical trials of 24 investigational compounds, including 16 (67%) positive and 8 (33%) negative events. The majority of announcements were for Phase 3 clinical trials (N = 13, 54%), and for oncologic (N = 7, 29%) and neurologic (N = 6, 24%) indications. The median cumulative abnormal returns on the day of the announcement were 0.8% (95% confidence interval [CI]: -2.3, 13.4%; P = 0.02) for positive events and -2.0% (95% CI: -9.1, 0.7%; P = 0.04) for negative events, with statistically significant differences from zero. In the day immediately following the announcement, firms with positive events were associated with stock price corrections, with median cumulative abnormal returns falling to 0.4% (95% CI: -3.8, 12.3%; P = 0.33). For firms with negative announcements, the median cumulative abnormal returns were -1.7% (95% CI: -9.5, 1.0%; P = 0.03), and remained significantly negative over the two day event window. The magnitude of abnormal returns did not differ statistically by indication, by trial phase, or between biotechnology and pharmaceutical firms. The release of clinical trial results is an economically significant event and has meaningful effects on market value for large biopharmaceutical companies. Stock return underperformance due to negative events is greater in magnitude and persists longer than

  13. 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

  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. Gambling disorder in financial markets: Clinical and treatment-related features.

    Science.gov (United States)

    Shin, Young-Chul; Choi, Sam-Wook; Ha, Juwon; Choi, Jung-Seok; Kim, Dai-Jin

    2015-12-01

    To date, few studies have examined the clinical manifestation of disordered gamblers in financial markets. This study examined the differences in the clinical and treatment-related features of gambling disorder between financial markets and horse races. Subjects who met the DSM-IV criteria for pathological gambling (PG) and who sought treatment were assessed by retrospective chart review. One hundred forty-four subjects were included in this sample, which consisted of the following groups: financial markets (n = 45; 28.6%) and horse races (n = 99; 71.4%). Multiple similar manifestations were found between the groups, including severity of PG, age of PG onset, amounts of gambling debts, drinking days per week, depressive mood, duration of seeking treatment after the onset of PG, and treatment follow-up duration. However, disordered gamblers who invested in the financial market were significantly more likely to be educated (p = 0.003), live with their spouses (p = 0.007), have full-time jobs (p = 0.006), and they were more likely to participate in the first type of gambling than the horse races group (pfinancial markets group received the anti-craving medication less often than the horse races group (p = 0.04). These findings suggest that disordered gamblers in financial markets show different socio-demographic, clinical and treatment-related features compared with the horse race gamblers, despite a similar severity of gambling disorder. Understanding these differential manifestations may provide insight into prevention and treatment development for specific types of gambling.

  16. Pre-Clinical Medical Students' Exposure to and Attitudes Toward Pharmaceutical Industry Marketing.

    Science.gov (United States)

    Fein, Eric H; Vermillion, Michelle L; Uijtdehaage, Sebastian H J

    2007-12-01

    Background - Recent studies have examined the exposures and attitudes of physicians and third- and fourth-year medical students toward pharmaceutical industry marketing, but fewer studies have addressed these topics among pre-clinical medical students. Thus, the purpose of this study was to assess pre-clinical students' level of exposure to the pharmaceutical industry and their attitudes toward marketing. Method - First and second-year medical students at UCLA completed a 40-item survey based on previous studies. Results - Over three quarters of pre-clinical students (78.5% or 226 of 288) responded to the survey. Exposure to pharmaceutical industry marketing started very early in medical school. Most second-year students (77%) had received gifts including drug samples after three semesters. Most felt that this would not affect their future prescribing behavior. Conclusions - These findings and findings from related studies, coupled with the students' desire to learn more about the issue, suggest that an early educational intervention addressing this topic may be warranted in American medical schools.

  17. 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.

  18. Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

    Science.gov (United States)

    Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

    2016-01-01

    Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

  19. [Clinical impact of social marketing strategy on breast cancer detection].

    Science.gov (United States)

    Quintana-Vidaurri, Adriana Guadalupe; Santana-Chávez, Luis Alejandro; González-Villalobos, Cynthia Guadalupe

    2013-01-01

    to prove the impact of social marketing strategies in breast cancer detection, taking as a parameter the number of mammographies performed. quasi-experimental research, before and after. Sixty-nine physicians in charge of medical consultation and fourteen nurses were studied for a period of seven months, applying social marketing strategies. The total of mammographies were analyzed using Wilcoxon rank-sum test (p marketing proved to be an adequate strategy, which has an impact on the clinical practice of both physicians and nurses.

  20. 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).

  1. 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

  2. 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.

  3. 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...

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. [Exploration and demonstration study on drug combination from clinical real world].

    Science.gov (United States)

    Xie, Yan-ming; Wang, Lian-xin; Wang, Yong-yan

    2014-09-01

    Drug combination is extensive in the clinical real world,which is an important part and the inherent requirements of the post-marketing evaluation of traditional Chinese medicine (TCM). The key issues and technology include multi-domain and multi-disciplinary such as the rationality, efficacy and safety evaluation of combination drug starting from clinical real world, study on component in vivo and mechanism of combination drug, the risk/benefit assessment and cost-benefit evaluation of combination drug and so on. The topic has been studied as clinical demonstration on combination therapy of variety of diseases such as coronary heart disease, stroke, insomnia, depression, hepatitis, herpes zoster, psoriasis and ectopic pregnancy. Meanwhile, multi-disciplinary dynamic innovation alliance of clinical drug combination has been presented, which can promote the academic development and improving service ability and level of TCM.

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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…

  14. 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

  15. Post-Essure hysterosalpingography compliance in a clinic population.

    Science.gov (United States)

    Shavell, Valerie I; Abdallah, Mazen E; Diamond, Michael P; Kmak, David C; Berman, Jay M

    2008-01-01

    To determine the follow-up rate for post-Essure hysterosalpingography (HSG) in a non-study, general clinic population in an urban environment. Retrospective chart review (Canadian Task Force classification II-2). University teaching hospital. Eighty-three University Health Center (UHC) patients who underwent attempted placement of the Essure permanent birth control device at the ambulatory surgery center at Hutzel Women's Hospital from January 2003 through June 2007. Hysteroscopic placement of the Essure permanent birth control device. Placement of the Essure permanent birth control device was attempted in 83 patients, of which 79 were successfully completed (95.2%). Of the 79 patients, 10 underwent post-Essure HSG (12.7%). HSG was performed 3 to 6 months after placement of the Essure device. Bilateral tubal occlusion was documented in all 10 patients. Despite preoperative and postoperative counseling, the follow-up rate for post-Essure HSG for this clinic population was only 12.7%. For those in whom HSG was performed, bilateral tubal occlusion was confirmed in all. Steps or approaches to promote compliance with postprocedural confirmation of tubal occlusion should be utilized to improve future follow-up rates.

  16. 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.

  17. 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.

  18. Clinical evaluation of post-extraction site wound healing.

    Science.gov (United States)

    Adeyemo, Wasiu Lanre; Ladeinde, Akinola Ladipo; Ogunlewe, Mobolanle Olugbemiga

    2006-07-01

    The aim of this prospective study was to evaluate the clinical pattern of post-extraction wound healing with a view to identify the types, incidence, and pattern of healing complications following non-surgical tooth extraction. A total of 311 patients, who were referred for non-surgical (intra-alveolar) extractions, were included in the study. The relevant pre-operative information recorded for each patient included age and gender of the patient, indications for extraction, and tooth/teeth removed. Extractions were performed under local anesthesia with dental forceps, elevators, or both. Patients were evaluated on the third and seventh postoperative days for alveolus healing assessment. Data recorded were: biodata, day of presentation for alveolus healing assessment, day of onset of any symptoms, body temperature (degrees C) in cases of alveolus infection, and presence or absence of pain. Two hundred eighty-two patients (282) with 318 extraction sites were evaluated for alveolus healing. Healing was uneventful in 283 alveoli (89%), while 35 alveoli (11%) developed healing complications. These complications were: localized osteitis 26 (8.2%); acutely infected alveolus 5 (1.6%); and an acutely inflamed alveolus 4 (1.2%). Females developed more complications than males (p=0.003). Most complications were found in molars (60%) and premolars (37.1%). Localized osteitis caused severe pain in all cases, while infected and inflamed alveolus caused mild or no pain. Thirty patients (12%) among those without healing complications experienced mild pain. Most of the post-extraction alveoli healed uneventfully. Apart from alveolar osteitis (AO), post-extraction alveolus healing was also complicated by acutely infected alveoli and acutely inflamed alveoli. This study also demonstrated a painful alveolus is not necessarily a disturbance of post-extraction site wound healing; a thorough clinical examination must, therefore, be made to exclude any of the complications.

  19. [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

  20. Big Pharma on the Farm: Students Are Exposed to Pharmaceutical Marketing More Often in Rural Clinics.

    Science.gov (United States)

    Evans, David V; Keys, Toby; Desnick, Laurel; A Andrilla, C Holly; Bienz, Danielle; Rosenblatt, Roger

    2016-07-01

    Pharmaceutical marketing techniques are effective in changing the behavior of health care providers in ways that deviate from evidence-based practices. To mitigate the influence of pharmaceutical marketing on learners, academic medical centers (AMCs) have adopted policies to limit student/industry interaction. Many clinical experiences occur outside of the AMC. The purpose of this study was to compare medical students' exposure to pharmaceutical marketing in off-campus rural and urban underserved clinical sites. The University of Washington School of Medicine Rural and Underserved Opportunities Program (RUOP) places rising second-year medical students in underserved clinical sites in five northwestern states. We surveyed RUOP students to evaluate their exposure to pharmaceutical marketing. Of 120 students, 86 (72%) completed surveys. Sixty-five (76%) did their RUOP rotation in rural areas. Students in rural locations were more likely to report exposure to pharmaceutical marketing. Distribution of free drug samples was reportedly three times higher in rural than urban sites (54% versus 15%). Doctors meeting with sales representatives were reported as four times higher in rural clinics (40% versus 10%). Students at rural sites reported exposure to pharmaceutical marketing more than those in urban settings. Rural medical educators should provide faculty development for community clinicians on the influences of pharmaceutical marketing on learners. Medical schools must review local clinic and institution-wide policies to limit pharmaceutical marketing exposure to learners in the rural learning environment.

  1. 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.

  2. Evaluating the impact of a quality management intervention on post-abortion contraceptive uptake in private sector clinics in western Kenya: a pre- and post-intervention study.

    Science.gov (United States)

    Wendot, Susy; Scott, Rachel H; Nafula, Inviolata; Theuri, Isaac; Ikiugu, Edward; Footman, Katharine

    2018-01-19

    Integration of family planning counselling and method provision into safe abortion services is a key component of quality abortion care. Numerous barriers to post-abortion family planning (PAFP) uptake exist. This study aimed to evaluate the effect of a quality management intervention for providers on PAFP uptake. We conducted a pre- and post-intervention study between November 2015 and July 2016 in nine private clinics in Western Kenya. We collected baseline and post-intervention data using in-person interviews on the day of procedure, and follow-up telephone interviews to measure contraceptive uptake in the 2 weeks following abortion. We also conducted semi-structured interviews with providers. The intervention comprised a 1-day orientation, a counselling job-aide, and enhanced supervision visits. The primary outcome was the proportion of clients receiving any method of PAFP (excluding condoms) within 14 days of obtaining an abortion. Secondary outcomes were the proportion of clients receiving PAFP counselling, and the proportion of clients receiving long-acting reversible contraception (LARC) within 14 days of the service. We used chi-squared tests and multivariate logistic regression to determine whether there were significant differences between baseline and post-intervention, adjusting for potential confounding factors and clustering at the clinic level. Interviews were completed with 769 women, and 54% (414 women) completed a follow-up telephone interview. Reported quality of counselling and satisfaction with services increased between baseline and post-intervention. Same-day uptake of PAFP was higher at post-intervention compared to baseline (aOR 1.94, p quality of their services. A quality management intervention was successful in improving the quality of PAFP counselling and provision. Uptake of same-day PAFP, including LARC, increased, but there was no increase in overall uptake of PAFP 2 weeks after the abortion.

  3. 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...

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. [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

  9. Effect of a clinic-wide social marketing campaign to improve adherence to antiretroviral therapy for HIV infection.

    Science.gov (United States)

    Giordano, Thomas P; Rodriguez, Sonia; Zhang, Hong; Kallen, Michael A; Jibaja-Weiss, Maria; Buscher, April L; Arya, Monisha; Suarez-Almazor, Maria E; Ross, Michael

    2013-01-01

    This demonstration study tested the impact of a 5-month clinic-wide social marketing campaign at improving adherence to antiretroviral therapy (ART). The intervention included a video, posters, pens, mugs, and lapel buttons with the campaign slogan "Live the Solution: Take Your Pills Every Day." Participants self-reported adherence over a 4-week interval, the primary outcome, with a visual analogue scale. Pre- and post-intervention surveys were completed by 141 participants. Adherence did not change over time (absolute mean change -2.02 %, paired t test P = 0.39). Among the 39.7 % of participants who correctly identified the campaign slogan on the post-intervention survey, adherence increased by 3.3 %, while it decreased in the other participants by 5.5 % (paired t test P = 0.07). The well-received campaign did not increase short-term adherence to ART, but adherence tended to increase in participants who were more engaged with the intervention. Future interventions should engage patients more completely and have a more potent effect on adherence.

  10. Contemporary Aspects of Marketing in Clinical Trials Including Segments of IT and Technology Transfer

    Science.gov (United States)

    Stamenovic, Milorad; Dobraca, Amra; Smajlovic, Mersiha

    2018-01-01

    Introduction: The aim of this paper is to present the marketing strategy and the application of management (marketing management) and advertising in order to increase the efficiency of innovative approach in clinical trials that include and involve the use of new technologies and transfer of technologies. Material and Methods: This paper has a descriptive character and represents a narrative review of the literature and new model implementation. Results: Marketing models are primarily used to improve the inclusion of a larger (and appropriate) number of patients, but they can be credited for the stay and monitoring of patients in the trial. Regulatory mechanisms play an important role in the application of various marketing strategies within clinical trials. The value for the patient as the most important stakeholder is defined in the field of clinical trials according to Kotler’s value model for the consumer. Conclusion: In order to achieve the best results it is important to adequately examine all the elements of clinical trials and apply this knowledge in creation of a marketing plan that will be made in accordance with the legal regulations defined globally and locally. In this paper, two challenges have been highlighted for the adequate application of marketing tools in the field of clinical trials, namely: defining business elements in order to provide an adequate marketing approach for clinical trials and technology transfer and ensuring uniformity and regulatory affirmation of marketing attitudes in clinical trials in all regions in which they are carried out in accordance with ICH-GCP and valid regulations. PMID:29719318

  11. Contemporary Aspects of Marketing in Clinical Trials Including Segments of IT and Technology Transfer.

    Science.gov (United States)

    Stamenovic, Milorad; Dobraca, Amra; Smajlovic, Mersiha

    2018-01-01

    The aim of this paper is to present the marketing strategy and the application of management (marketing management) and advertising in order to increase the efficiency of innovative approach in clinical trials that include and involve the use of new technologies and transfer of technologies. This paper has a descriptive character and represents a narrative review of the literature and new model implementation. Marketing models are primarily used to improve the inclusion of a larger (and appropriate) number of patients, but they can be credited for the stay and monitoring of patients in the trial. Regulatory mechanisms play an important role in the application of various marketing strategies within clinical trials. The value for the patient as the most important stakeholder is defined in the field of clinical trials according to Kotler's value model for the consumer. In order to achieve the best results it is important to adequately examine all the elements of clinical trials and apply this knowledge in creation of a marketing plan that will be made in accordance with the legal regulations defined globally and locally. In this paper, two challenges have been highlighted for the adequate application of marketing tools in the field of clinical trials, namely: defining business elements in order to provide an adequate marketing approach for clinical trials and technology transfer and ensuring uniformity and regulatory affirmation of marketing attitudes in clinical trials in all regions in which they are carried out in accordance with ICH-GCP and valid regulations.

  12. [The Marketing of Healthcare Services in ENT-Clinics].

    Science.gov (United States)

    Teschner, M; Lenarz, T

    2016-07-01

    The provision of healthcare services in Germany is based on fundamental principles of solidarity and is highly regulated. The question arises which conditions exist for marketing for healthcare services in ENT-clinics in Germany. The marketing options will be elicited using environmentally analytical considerations. The objectives can be achieved using measures derived from external instruments (service policy, pricing policy, distribution policy or communications policy) or from an internal instrument (human resources policy). The policy environment is particularly influenced by the regulatory framework, which particularly restricts the scope for both the pricing and communications policies. All measures must, however, reflect ethical frameworks, which are regarded as the fundamental premise underlying healthcare services and may be at odds with economic factors. Scope for flexibility in pricing exists only within the secondary healthcare market, and even there only to a limited extent. The significance of price in the marketing of healthcare services is thus very low. If marketing activities are to succeed, a market analysis must be carried out exploring the relevant factors for each individual provider. However, the essential precondition for the marketing of healthcare services is trust. The marketing of healthcare services differs from that of business management-oriented enterprises in other branches of economy. In the future the importance of marketing activities will increase. © Georg Thieme Verlag KG Stuttgart · New York.

  13. Pre- and post-bronchodilator airway obstruction are associated with similar clinical characteristics but different prognosis – report from a population-based study

    Directory of Open Access Journals (Sweden)

    Sawalha S

    2017-04-01

    Full Text Available Sami Sawalha,1 Linnea Hedman,2 Eva Rönmark,2 Bo Lundbäck,3 Anne Lindberg1 1Department of Public Health and Clinical Medicine, Division of Medicine, 2Department of Public Health and Clinical Medicine, The OLIN Unit, Division of Occupational and Environmental Medicine, Umeå University, Umeå, 3Krefting Research Center, Institution of Medicine, University of Gothenburg, Gothenburg, Sweden Introduction: According to guidelines, the diagnosis of COPD should be confirmed by post-bronchodilator (post-BD airway obstruction on spirometry; however, in clinical practice, this is not always performed. The aim of this population-based study was to compare clinical characteristics and prognosis, assessed as mortality, between subjects with airway obstruction divided into pre- but not post-BD obstruction, post-BD airway obstruction (COPD, and subjects without airway obstruction.Materials and methods: In 2002–2004, four adult population-based cohorts were reexamined with spirometry and structured interview. Subjects with airway obstruction, with a ratio of forced expiratory volume in 1 s to (forced vital capacity <0.70 (n=993, were identified together with sex- and age-matched referents (n=993. These subjects were further divided into subjects with pre- but not post-BD airway obstruction (pre- not post-BD obstruction and subjects with post-BD airway obstruction (COPD. Mortality data were collected until December 31, 2014.Results: Out of 993 subjects with airway obstruction, 736 (74% had COPD and 257 (26% pre- not post-BD obstruction. Any respiratory symptoms, allergic rhinitis, asthma, exacerbations, and comorbidities were equally common among subjects with COPD and pre- not post-BD obstruction, but less common among nonobstructive subjects. Mortality was highest among subjects with COPD and higher in men than in women. In both sexes, COPD, but not pre- not post-BD obstruction, was associated with an increased risk for death compared to those without

  14. 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...

  15. 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.

  16. Effects of an intensive clinical skills course on senior nursing students' self-confidence and clinical competence: A quasi-experimental post-test study.

    Science.gov (United States)

    Park, Soohyun

    2018-02-01

    To foster nursing professionals, nursing education requires the integration of knowledge and practice. Nursing students in their senior year experience considerable stress in performing the core nursing skills because, typically, they have limited opportunities to practice these skills in their clinical practicum. Therefore, nurse educators should revise the nursing curricula to focus on core nursing skills. To identify the effect of an intensive clinical skills course for senior nursing students on their self-confidence and clinical competence. A quasi-experimental post-test study. A university in South Korea during the 2015-2016 academic year. A convenience sample of 162 senior nursing students. The experimental group (n=79) underwent the intensive clinical skills course, whereas the control group (n=83) did not. During the course, students repeatedly practiced the 20 items that make up the core basic nursing skills using clinical scenarios. Participants' self-confidence in the core clinical nursing skills was measured using a 10-point scale, while their clinical competence with these skills was measured using the core clinical nursing skills checklist. Independent t-test and chi-square tests were used to analyze the data. The mean scores in self-confidence and clinical competence were higher in the experimental group than in the control group. This intensive clinical skills courses had a positive effect on senior nursing students' self-confidence and clinical competence for the core clinical nursing skills. This study emphasizes the importance of reeducation using a clinical skills course during the transition from student to nursing professional. Copyright © 2017. Published by Elsevier Ltd.

  17. 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.

  18. Prevalence and concordance between the clinical and the post-mortem diagnosis of dementia in a psychogeriatric clinic.

    Science.gov (United States)

    Grandal Leiros, B; Pérez Méndez, L I; Zelaya Huerta, M V; Moreno Eguinoa, L; García-Bragado, F; Tuñón Álvarez, T; Roldán Larreta, J J

    The aim of our study is to describe the types of dementia found in a series of patients and to estimate the level of agreement between the clinical diagnosis and post-mortem diagnosis. We conducted a descriptive analysis of the prevalence of the types of dementia found in our series and we established the level of concordance between the clinical and the post-mortem diagnoses. The diagnosis was made based on current diagnostic criteria. 114 cases were included. The most common clinical diagnoses both at a clinical and autopsy level were Alzheimer disease and mixed dementia but the prevalence was quite different. While at a clinical level, prevalence was 39% for Alzheimer disease and 18% for mixed dementia, in the autopsy level, prevalence was 22% and 34%, respectively. The agreement between the clinical and the autopsy diagnoses was 62% (95% CI 53-72%). Almost a third of our patients were not correctly diagnosed in vivo. The most common mistake was the underdiagnosis of cerebrovascular pathology. Copyright © 2016 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

  19. 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...

  20. 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.

  1. 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.

  2. CT and clinical study for intratumoral gas formation in post transarterial embolization of hepatoma and renal cell carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Katsuragi, M; Matsuo, N; Yoshikawa, K [Nara Medical Univ., Kashihara (Japan)

    1982-09-01

    Thirty-two patients with hepatocellular carcinoma and six patients with renal cell carcinoma for whom the arterial embolization therapy was performed were studied by CT and clinical follow-up for investigating intratumoral gas detected on CT in post-embolization cases. The intratumoral air was found by CT in seven patients with hepatocellular carcinoma and four patients with renal cell carcinoma. The air was composed of a collection of multiple small round gas bubbles in the embolized tumor except in one case where it formed a serpiginous pattern. There was no hematologic nor clinical evidence of liver abscess in all the cases. It was possible to distinguish gas from abscess or fat by a combination of CT and clinical findings.

  3. Study of Marketing Components Affecting Health Care Services in Hospitals

    Directory of Open Access Journals (Sweden)

    Mohammad Javad Akbarian Bafghi

    2016-10-01

    Full Text Available Background: Hospitals, in extreme competition, have accepted principles of marketing designed for industrial goods and customers. One of the important factors in health services marketing is the type of services. Organizations, including health centers, require meeting the clients' needs in order to survive and try to promote the way of providing services effectively. The present study aims to identify effective components in providing clinical services in hospitals. Methods: This was a practical and cross-sectional study. Data were collected using a questionnaire completed through random sampling after confirming the validity and reliability. Data were analyzed by SPSS 21 and Lisrel 8.50 using descriptive statistics and factor analysis. Results: The results of this study indicated that nine components had the highest impact on providing health services. Confirmatory factor analysis showed that the quality of providing services in the hospital, offering distinctive services compared with other hospitals, and considering quality of service beyond the patient's expectation had the greatest impact on marketing services in the hospital. Conclusion: Providing quality and distinctive services beyond the patient's expectation enables hospitals to improve their marketing activities and, beside higher level of patient satisfaction, develop their clinical services market share.

  4. POST OPERATIVE RECOVERY RESTLESSNESS FOLLOWING ENT SURGERIES IN THE PEDIATRIC AGE GROUP - A CLINICAL STUDY OF 246 CHILDREN

    Directory of Open Access Journals (Sweden)

    Nagula

    2015-10-01

    Full Text Available INTRODUCTION: Post - operative restlessness is observed commonly among children following Ear Nose Throat surgeries. This post anesthetic problem is also termed as Emergence Agitation (EA which interferes with patient’s recovery, presenting a challenging task to the ane sthetist in terms of assessment and convincing the parents. Many factors play a role singly or in combination in producing EA. EA consist of restlessness, excessive crying and spells of breath holding, head banging and incoherent speech. In this prospectiv e clinical study the incidence of post - operative recovery restlessness EA in children aged between 3 to 12 years, enumeration of the causes, and prediction of EA in Indian population. MATERIALS AND METHODS: 246 Children undergoing elective surgeries of Ear Nose and throat are selected and their demographic data, socio - economic back ground and emotional attachment with parents were elicited. Parents of the children were interviewed prior to surgery using a questionnaire enquiring of their children’s personal ity, and emotional attachment and meekness. Their preoperative clinical data are documented. Their post - operative general condition, behavior, time taken for awakening, period of total recovery and treatment factors are recorded and analyzed. RESULTS: The incidence of EA was found in 23.6% of the children. EA lasted between 21 minutes to 52 minutes with a mean period of 28.4±9.5 minutes. 67% of the children required medication with sedatives, analgesics and anti - emetics. Post - operative stay in the Surgical ICU ranged between Hrs . 3.12±0.36mts to Hrs . 8.39±2.10mts in the children showing restlessness, compared to those not showing agitation. CONCLUSIONS: The factors associated with EA were, age, emotional attachment, meekness, adaptability, previous surgery, analgesics, sedatives, dose of pentothal sodium for induction, time taken for awakening and duration of surgery. Shorter was the time of awakening

  5. 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.

  6. Post-infectious bronchiolitis obliterans: clinical, radiological and pulmonary function sequelae

    International Nuclear Information System (INIS)

    Chang, A.B.; Masel, J.P.; Masters, B.

    1998-01-01

    Background. There are few data on clinical, chest radiograph (CXR) or pulmonary function sequelae in children with post-infectious bronchiolitis obliterans (BO) (pulmonary crepitations, abnormalities on CXR, CT, nuclear medicine scans, or bronchography, with a history of past pulmonary infection and in the absence of other underlying pathology). Objective. To analyse the methodology of diagnosis, long-term clinical imaging and pulmonary function sequelae of post-infectious BO in children. Materials and methods. Imaging (CXRs, CT and nuclear lung scans) and clinical histories of 19 children were analysed. Results. Clinical follow-up (mean 6.8 years), revealed a high incidence of continuing problems (asthma and bronchiectasis). Fixed airway obstruction was the most common pulmonary function sequela. The sequelae on follow-up (mean 5.8 years) CXR were classified into five patterns which are illustrated: unilateral hyperlucency of an enlarged lung/part of lung; complete collapse of the affected lobe; unilateral hyperlucency of a small or normal-sized lung; bilateral hyperlucent lungs and a mixed pattern of persistent collapse, hyperlucency and peribronchial thickening. Conclusion. Long-term observations in children with post-infectious BO should be undertaken to detect bronchiectasis and obstructive airway disease. Sequelae evident on CXR, other than those previously described, can be found. Bronchography and/or lung biopsy are not usually required for the diagnosis of post-infectious BO. (orig.)

  7. Clinical use of metal post- case report

    OpenAIRE

    Denkova, Natasa; Zlatanovska, Katerina; Kovacevska, Ivona; Nedelkova, Marija; Denkov, Nikola

    2016-01-01

    Background: Some teeth are severely mutilated because of caries or trauma. In case of an evident horizontal loss of clinical crown, most of the teeth could be unable to retain the final restoration without some additional support. Among other means, after endodontic treatment the use of endodontic posts can now be avoided in many cases. Aim:The aim of this case report was to show our management on teeth with evident loss of clinical crown from caries without set a prosthetic rehabilitation...

  8. Octogenarians' post-acute care use after cardiac valve surgery and recovery: clinical implications.

    Science.gov (United States)

    Edmiston, Elizabeth; Dolansky, Mary A; Zullo, Melissa; Forman, Daniel E

    2017-12-21

    Octogenarians receiving cardiac valve surgery is increasing and recovery is challenging. Post-acute care (PAC) services assist with recovery, yet services provided in facilities do not provide adequate cardiac-focused care or long-term self-management support. The purpose of the paper was to report post-acute care discharge rates in octogenarians and propose clinical implications to improve PAC services. Using a 2003 Medicare Part A database, we studied post-acute care service use in octogenarians after cardiac valve surgery. We propose expansion of the Geriatric Cardiac Care model to include broader clinical therapy dynamics. The sample (n = 10,062) included patients over 80 years discharged from acute care following valve surgery. Post-acute care services were used by 68% of octagarians following cardiac valve surgery (1% intermediate rehabilitation, 35% skilled nursing facility, 32% home health). The large percentage of octagarians using PAC point to the importance of integrating geriatric cardiac care into post-acute services to optimize recovery outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.

    Science.gov (United States)

    2010-01-21

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals. The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.

  10. 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)

  11. Clinical trial management of participant recruitment, enrollment, engagement, and retention in the SMART study using a Marketing and Information Technology (MARKIT) model.

    Science.gov (United States)

    Gupta, Anjali; Calfas, Karen J; Marshall, Simon J; Robinson, Thomas N; Rock, Cheryl L; Huang, Jeannie S; Epstein-Corbin, Melanie; Servetas, Christina; Donohue, Michael C; Norman, Gregory J; Raab, Fredric; Merchant, Gina; Fowler, James H; Griswold, William G; Fogg, B J; Patrick, Kevin

    2015-05-01

    Advances in information technology and near ubiquity of the Internet have spawned novel modes of communication and unprecedented insights into human behavior via the digital footprint. Health behavior randomized controlled trials (RCTs), especially technology-based, can leverage these advances to improve the overall clinical trials management process and benefit from improvements at every stage, from recruitment and enrollment to engagement and retention. In this paper, we report the results for recruitment and retention of participants in the SMART study and introduce a new model for clinical trials management that is a result of interdisciplinary team science. The MARKIT model brings together best practices from information technology, marketing, and clinical research into a single framework to maximize efforts for recruitment, enrollment, engagement, and retention of participants into a RCT. These practices may have contributed to the study's on-time recruitment that was within budget, 86% retention at 24 months, and a minimum of 57% engagement with the intervention over the 2-year RCT. Use of technology in combination with marketing practices may enable investigators to reach a larger and more diverse community of participants to take part in technology-based clinical trials, help maximize limited resources, and lead to more cost-effective and efficient clinical trial management of study participants as modes of communication evolve among the target population of participants. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  12. Clinical trial management of participant recruitment, enrollment, engagement, and retention in the SMART study using a Marketing and Information Technology (MARKIT) model

    Science.gov (United States)

    Gupta, Anjali; Calfas, Karen J.; Marshall, Simon J.; Robinson, Thomas N.; Rock, Cheryl L.; Huang, Jeannie S.; Epstein-Corbin, Melanie; Servetas, Christina; Donohue, Michael C.; Norman, Gregory J.; Raab, Fredric; Merchant, Gina; Fowler, James H.; Griswold, William G.; Fogg, B.J.; Patrick, Kevin

    2015-01-01

    Advances in information technology and near ubiquity of the Internet have spawned novel modes of communication and unprecedented insights into human behavior via the digital footprint. Health behavior randomized controlled trials (RCTs), especially technology-based, can leverage these advances to improve the overall clinical trials management process and benefit from improvements at every stage, from recruitment and enrollment to engagement and retention. In this paper, we report the results for recruitment and retention of participants in the SMART study and introduce a new model for clinical trials management that is a result of interdisciplinary team science. The MARKIT model brings together best practices from information technology, marketing, and clinical research into a single framework to maximize efforts for recruitment, enrollment, engagement, and retention of participants into a RCT. These practices may have contributed to the study’s on-time recruitment that was within budget, 86% retention at 24 months, and a minimum of 57% engagement with the intervention over the 2-year RCT. Use of technology in combination with marketing practices may enable investigators to reach a larger and more diverse community of participants to take part in technology-based clinical trials, help maximize limited resources, and lead to more cost-effective and efficient clinical trial management of study participants as modes of communication evolve among the target population of participants. PMID:25866383

  13. Marketing the interventional clinical practice to the referring community and to patients.

    Science.gov (United States)

    Murphy, Timothy P; Soares, Gregory M

    2005-03-01

    If interventionalists are able to set up clinical practices and promote themselves along service lines, especially peripheral arterial disease, it is likely that they will have some market share and that market share will grow as new devices and technologies become available. The key to success will be changing the impression of the referring community that interventional radiologists are technical specialists and don't see patients. Marketing experts tell us that several impressions are required for a concept to stick with the target audience. One of the most important points that an interventionalist can make to establish themselves as a clinical specialty is high-quality work and effective communications.

  14. Pediatric dentistry clinical education venues evaluation by pre and post-doctoral students.

    Science.gov (United States)

    Bimstein, E; Mayes, A; Mittal, Hc

    2014-01-01

    To evaluate dental students' perspectives about pre- and post-doctoral pediatric dentistry education venues. Surveys with visual analog scales (from 0 to 100) measuring the educational contribution of pediatric dentistry venues were conducted. The pre-doctoral venues included a 3rd year university twilight clinic (UTC), a 3rd year urban community based clinic (CBC) and 4th year mobile clinics (MCs). The post-doctoral venues included treatment of children under general anesthesia, oral sedations, a regular clinic (no sedations), seminars, journal club, case conferences and studding for the American Board of Pediatric Dentistry. Analyses of variance between the scores indicated that the 3rd year CBC score (68.2 ± 4.5) was statistically significant higher (p= .007) than the one for the 3rd year UTC score (44.9 ± 6.1). The 4th year students' MCs score (61.4 ± 4.0) was statistically significant higher than their retrospective scores for the 3rd year CBC (56.4 ± 4.4) or UTC (42.2 ± 4.9) scores (p= .03 and .004 respectively). Among the didactic or clinical post-doctoral venues, the regular clinic and the seminars received the highest scores (84.3 ± 1.7 and 71.6 ± 2.8 respectively). pre-doctoral community-based clinical education and post-doctoral regular university based clinic are considered by students to provide the main contribution to pediatric dental education.

  15. 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,

  16. Post-operative cognitive dysfunction in the elderly: A prospective clinical study

    Directory of Open Access Journals (Sweden)

    Nalini Kotekar

    2014-01-01

    Full Text Available Background and Aims: Aging population is a major demographic trend worldwide. Globally, 50% of all the elderly individuals are estimated to undergo atleast one surgical procedure and post-operative cognitive dysfunction (POCD is one of the most common and often poorly understood post-operative complications in this section of the population. This randomised prospective study was conducted to assess the post-operative cognitive status in the elderly undergoing non-cardiac surgery, evaluate the cognitive parameters affected, evaluate the potential risk factors and thereby analyse the potential for implementation of preventive strategies. Methods: This study was conducted on 200 patients aged 60 years or older scheduled for elective non-cardiac surgeries. The baseline cognitive status of the patients was assessed 2 days prior to the date of the surgery. The post-operative cognitive status was assessed on the 3 rd day, 7 th day and after 1 month. Statistical analysis was performed using SAS and SPSS. Results: The incidence of POCD showed a gradual decline from postoperative day 3 to 30. Females were found to be at significant risk in developing POCD. Advancing age and level of education emerged as dominant factors, while type of anaesthesia, duration of surgery, and presence of coexisting comorbidities had no influence on the incidence of cognitive dysfunction. Conclusion: POCD is a definite complication after surgery and anaesthesia in the elderly population. Gender emerged as a significant risk factor with increasing age as a dominating factor contributing to POCD.

  17. 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.

  18. 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),

  19. The development of market power in the Spanish power generation sector: Perspectives after market liberalization

    International Nuclear Information System (INIS)

    Ciarreta, Aitor; Nasirov, Shahriyar; Silva, Carlos

    2016-01-01

    This paper provides a comprehensive analysis of the market power problem in the Spanish power generation sector and examines how and to which extent the market has developed in terms of market power concerns after the market liberalization reforms. The methodology applied in this study includes typical ex-post structural and behavioral measures employed to estimate potential for market power, namely: concentration ratios (CR) (for the largest and the three largest suppliers), the Herfindahl–Hirschman Index (HHI), Entropy, Pivotal Supply Index, the Residual Supply Index and Residual Demand Elasticity (RDE). The results are presented for the two largest Spanish generating companies (Endesa and Iberdrola) acting in the Iberian Electricity Market (MIBEL), and in the Spanish Day-ahead electricity market. The results show evidence that these companies have behaved much more competitively in recent periods than in the beginning of the market liberalization. In addition, the paper discusses important structural and regulatory changes through market liberalization processes in the Spanish Day-ahead electricity market. - Highlights: •Competition and regulation in the Spanish electricity market. •The methodology applied in this study: ex-post structural and behavioral measures. •Key dominant companies behaved more competitively in recent periods. •Important structural and regulatory changes in the Spanish electricity market.

  20. Post-surgical enterococcal meningitis: clinical and epidemiological study of 20 cases.

    Science.gov (United States)

    Guardado, Rodríguez; Asensi, V; Torres, J M; Pérez, F; Blanco, A; Maradona, J A; Cartón, J A

    2006-01-01

    Enterococcal post-surgical meningitis is an uncommon disease. 20 episodes of nosocomial post-surgical enterococcal meningitis diagnosed between 1994 and 2003 were retrospectively studied. During the period of study 20 cases of post-surgical enterococcal meningitis (60% female, mean age 55+/-18 y, range 16-78 y) were reviewed. The mean time between admission at the hospital and surgery was 26 (SD = 15) d (range 7-61 d). The most frequent underlying diseases were: intracerebral haemorrhage (55%), brain neoplasms (25%), head trauma (15%) and hydrocephalus (5%). 11 patients had previously received antibiotic treatment. The isolates identified were Enterococcus faecalis (n = 18) (90%), E. faecium (1) and E. durans (1). 11 patients had polymicrobial infections. The treatment most frequently used was vancomycin alone or with other antibiotics (11). In 5 patients intrathecal vancomycin (20 mg/d) was also added. The mortality rate was not different in intrathecally treated patients. Cerebrospinal fluid (CSF) devices were removed in 8 patients. Four patients died due to the infection. Mortality was significantly associated with lack of removal of the CSF devices (p = 0.04). Enterococcal spp. are a cause of nosocomial meningitis associated with neurosurgical procedures and the presence of neurological devices.

  1. 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.

  2. Effectiveness of hyaluronic acid in post-tonsillectomy pain relief and wound healing: a prospective, double-blind, controlled clinical study.

    Science.gov (United States)

    Hancı, Deniz; Altun, Huseyin

    2015-09-01

    To find the effectiveness of hyaluronic acid in post-tonsillectomy pain relief and wound healing. Fifty patients were included in this prospective, double-blind, controlled clinical study (20 males, 30 females mean age of 13.56 years). Hyaluronic acid was applied to one side and the other side was used as a control during tonsillectomy. Therefore, the same patient evaluated and scored the post-tonsillectomy pain, excluding individual bias. Results indicated that patients had significantly lower pain scores for hyaluronic acid treated side (pwound in the hyaluronic acid side was almost completely healed, indicating that the healing was faster with hyaluronic acid compared to control side (pwound healing. Copyright © 2015. Published by Elsevier Ireland Ltd.

  3. Clinical characteristics of post-neurosurgical Klebsiella pneumoniae meningitis in adults and a clinical comparison to the spontaneous form in a Taiwanese population.

    Science.gov (United States)

    Chang, Wen-Neng; Lu, Chen-Hsien; Huang, Chi-Ren; Chuang, Yao-Chung; Tsai, Nai-Wen; Chang, Chiung-Chih; Chen, Shu-Fang; Wang, Hung-Chen; Yang, Tzu-Ming; Hsieh, Mei-Jen; Chien, Chun-Chih

    2010-03-01

    A total of 46 patients (nine post-neurosurgical, 37 spontaneous) with adult bacterial meningitis (ABM) caused by Klebsiellapneumoniae infection were included in this study. The nine patients in the post-neurosurgical K. pneumoniae ABM group (seven male, two female) had a mean age of 48.9 years. Two patients in this group also had diabetes mellitus (DM) and one had liver disease. The most common presentation of patients in post-neurosurgical K. pneumoniae ABM group was fever (nine patients), followed by altered consciousness (seven patients) and hydrocephalus (six patients). With medical and/or surgical treatment, a mortality of 22.2% (2/9) occurred. Compared to patients who had spontaneous K. pneumoniae ABM, those with the post-neurosurgical form had a lower incidence of community-acquired infection, seizure and DM, but had a higher incidence of leukocytosis, hydrocephalus, cerebrospinal fluid leak and bacterial strains with extended-spectrum beta-lactamase. Univariate analysis found these clinical differences to be statistically significant, however they were not significant on multivariate analysis. This study reveals that there are clinical differences between the post-neurosurgical and spontaneous presentations of K. pneumoniae ABM. Copyright 2009 Elsevier Ltd. All rights reserved.

  4. Bacteriological And Clinical Evaluation Of Twelve Cases Of Post ...

    African Journals Online (AJOL)

    Bacteriological And Clinical Evaluation Of Twelve Cases Of Post-Surgical Sepsis Of Odontogenic Tumours At A ... East African Medical Journal ... Intervention: Adequate review of patient\\'s medical history, bacteriological investigations and

  5. 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)

  6. Marketing Plan and Marketing Research for KUAS Game Studies

    OpenAIRE

    Tukiainen, Reno

    2012-01-01

    This thesis was commissioned by Tieto^2 Project. The aim of the thesis was to study higher education marketing, including marketing planning and marketing research, from the point of view of marketing Kajaani University of Applied Sciences game study programmes. After the relevant theoretical literature was reviewed, a marketing research was conducted by interviewing current KUAS game students and new applicants who had applied for KUAS game studies in the spring of 2012. Based on the analyse...

  7. 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

  8. 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.

  9. [Comparison of clinical and histological diagnosis in kidney post-transplantation period].

    Science.gov (United States)

    de Castro, M C; Chocair, P R; Saldanha, L B; Nahas, W; Arap, S; Sabbaga, E; Ianhez, L E

    1998-01-01

    To assess the agreement between clinical and histopathological diagnosis in a renal transplantation center, 40 episodes of acute renal failure were studied. Kidney biopsies were performed at the moment that a clinical diagnosis was made by the staff. Nineteen episodes of acute tubular necrosis (ATN), eighteen episodes of acute cellular rejection (ACR), 2 humoral rejections and 1 acute cyclosporin nephrotoxicity episodes were diagnosed. ATN episodes were confirmed by renal biopsy in 84.21%, ACR episodes in 83.33%, humoral rejections in 100%. Renal biopsy showed ATN in the occurrence of clinical cyclosporin nephrotoxicity. Total agreement was 82.5%. There is a good relationship between clinical and histopathological diagnosis in the post-transplantation period. Diagnostic mistakes occurred mainly when oliguria was present.

  10. 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.

  11. Pre-market clinical evaluations of innovative high-risk medical devices in Europe.

    Science.gov (United States)

    Hulstaert, Frank; Neyt, Mattias; Vinck, Imgard; Stordeur, Sabine; Huić, Mirjana; Sauerland, Stefan; Kuijpers, Marja R; Abrishami, Payam; Vondeling, Hindrik; Flamion, Bruno; Garattini, Silvio; Pavlovic, Mira; van Brabandt, Hans

    2012-07-01

    High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.

  12. 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.

  13. [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.

  14. 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)

  15. Development of new radiopaque glass fiber posts

    Energy Technology Data Exchange (ETDEWEB)

    Furtos, Gabriel, E-mail: gfurtos@yahoo.co.uk [Raluca Ripan Institute of Research in Chemistry, Babes-Bolyai University, Cluj-Napoca (Romania); Baldea, Bogdan [Dep. of Prosthodontics, Faculty of Dental Medicine, Timisoara (Romania); Silaghi-Dumitrescu, Laura [Raluca Ripan Institute of Research in Chemistry, Babes-Bolyai University, Cluj-Napoca (Romania)

    2016-02-01

    The aim of this study was to analyze the radiopacity and filler content of three experimental glass fiber posts (EGFP) in comparison with other glass/carbon fibers and metal posts from the dental market. Three EGFP were obtained by pultrusion of glass fibers in a polymer matrix based on 2,2-bis[4-(2-hydroxy-3-methacryloyloxypropoxy)-phenyl]propane (bis-GMA) and triethyleneglycol dimethacrylate (TEGDMA) monomers. Using intraoral sensor disks 27 posts, as well as mesiodistal sections of human molar and aluminum step wedges were radiographed for evaluation of radiopacity. The percentage compositions of fillers by weight and volume were investigated by combustion analysis. Two EGFP showed radiopacity higher than enamel. The commercial endodontic posts showed radiopacity as follows: higher than enamel, between enamel and dentin, and lower than dentin. The results showed statistically significant differences (p < 0.05) when evaluated with one-way ANOVA statistical analysis. According to combustion analyses, the filler content of the tested posts ranges between 58.84 wt.% and 86.02 wt.%. The filler content of the tested EGFP ranged between 68.91 wt.% and 79.04 wt.%. EGFP could be an alternative to commercial glass fiber posts. Future glass fiber posts are recommended to present higher radiopacity than dentin and perhaps ideally similar to or higher than that of enamel, for improved clinical detection. The posts with a lower radiopacity than dentin should be considered insufficiently radiopaque. The radiopacity of some glass fiber posts is not greatly influenced by the amount of filler. - Highlights: • AR glass fibers for dental applications • AR glass fibers have a great potential for obtaining radiopaque glass fiber posts. • Experimental AR glass fiber posts could be an alternative to commercial glass fiber posts for clinical application.

  16. Development of new radiopaque glass fiber posts

    International Nuclear Information System (INIS)

    Furtos, Gabriel; Baldea, Bogdan; Silaghi-Dumitrescu, Laura

    2016-01-01

    The aim of this study was to analyze the radiopacity and filler content of three experimental glass fiber posts (EGFP) in comparison with other glass/carbon fibers and metal posts from the dental market. Three EGFP were obtained by pultrusion of glass fibers in a polymer matrix based on 2,2-bis[4-(2-hydroxy-3-methacryloyloxypropoxy)-phenyl]propane (bis-GMA) and triethyleneglycol dimethacrylate (TEGDMA) monomers. Using intraoral sensor disks 27 posts, as well as mesiodistal sections of human molar and aluminum step wedges were radiographed for evaluation of radiopacity. The percentage compositions of fillers by weight and volume were investigated by combustion analysis. Two EGFP showed radiopacity higher than enamel. The commercial endodontic posts showed radiopacity as follows: higher than enamel, between enamel and dentin, and lower than dentin. The results showed statistically significant differences (p < 0.05) when evaluated with one-way ANOVA statistical analysis. According to combustion analyses, the filler content of the tested posts ranges between 58.84 wt.% and 86.02 wt.%. The filler content of the tested EGFP ranged between 68.91 wt.% and 79.04 wt.%. EGFP could be an alternative to commercial glass fiber posts. Future glass fiber posts are recommended to present higher radiopacity than dentin and perhaps ideally similar to or higher than that of enamel, for improved clinical detection. The posts with a lower radiopacity than dentin should be considered insufficiently radiopaque. The radiopacity of some glass fiber posts is not greatly influenced by the amount of filler. - Highlights: • AR glass fibers for dental applications • AR glass fibers have a great potential for obtaining radiopaque glass fiber posts. • Experimental AR glass fiber posts could be an alternative to commercial glass fiber posts for clinical application.

  17. 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.

  18. [Impact of education program and clinical posting in psychiatry on medical students' stigmatizing attitudes towards psychiatry and psychiatric disorders].

    Science.gov (United States)

    Simon, N; Verdoux, H

    2017-06-09

    The aim of the study was to explore whether a medical student education program and clinical posting in psychiatry had an impact on medical students' stigmatizing attitudes towards psychiatry and psychiatric disorders. Medical students from the University of Bordeaux were recruited during their 4-year course at the beginning of the academic education program in psychiatry. Medical students who were concomitantly in a clinical posting in wards of psychiatry or neurology were invited to participate in the study. The medical student version of the scale Mental Illness: Clinicians' Attitudes (MICA) was used to measure their attitudes towards psychiatry and persons with psychiatric disorder. This 16-item scale is designed to measure attitudes of health care professionals towards people with mental illness, a higher score indicating more stigmatizing attitudes. Items exploring history of psychiatric disorders in close persons were added at the end of the MICA scale. The questionnaire was completed twice by each student, at the beginning and the end of the 11-week clinical posting. All questionnaires were strictly anonymized. Multivariate linear regression analyses were used to identify the variables independently associated with MICA total score. At the beginning of the education program and clinical posting, 174 students completed the MICA scale: the mean MICA total score was equal to 46.4 (SD 6.9) in students in clinical posting in psychiatry (n=72) and 45.1 (SD 7.01) in those in neurology (n=102). At the end of the academic and clinical training, 138 students again completed the questionnaire, with mean MICA total scores equal to 41.4 (SD 8.1) in students in clinical posting in psychiatry (n=51) and 43.5 (SD 7.3) in those in neurology (n=87). Multivariate analyses showed that lower total MICA scores were independently associated with the time of assessment (lower scores at the end of education program and clinical posting) (b=-2.8; P=0.001), female gender (b=-1.8; P=0

  19. 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.

  20. 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)

  1. A study of market efficiency in the stock market, forex market and bullion market in India

    OpenAIRE

    Sarker, Debnarayan; Ghosh, Bikash Kumar

    2007-01-01

    This study suggests that, run test, which are based on signs of indices / rates, do not reject efficient market hypothesis in the case of all the three markets, whereas VR tests, which capture the variation in permanent component of the series as a ratio to the total variation, reject the efficient market hypothesis in the case of the gold markets. Efficient market hypothesis in the case of Stock markets, Forex markets and Silver markets cannot be rejected based on VR tests. Since VR tests a...

  2. 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.

  3. 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

  4. Marketing faculty of Bucharest Economic Studies University: historic landmarks, present and future developments

    Directory of Open Access Journals (Sweden)

    Călin Petrică Vegheş

    2013-06-01

    Full Text Available This paper aims to present the main events that left their mark on the history and evolution of the Marketing Faculty of Bucharest Economic Studies University, an academic body that this will mark its 10th anniversary this fall. As the only school dedicated exclusively to the study of marketing in Romania, as well as one of the few exclusively marketing schools in Europe, the history of the Marketing Department and, subsequently, of the Marketing Faculty overlaps in the last four decades with that of Romanian marketing higher education, as well as with the graduate transformation of Romania’s economy to a post-industrial, information-based and customer centric economy. Part of Economic Sciences domain, marketing contains a set of concepts, tools, methods and techniques through which the organization, irrespective of its profile, analyzes the environment where it lives (marketing research, sets goals and strategies to be achieved (strategic marketing planning, design and execute operational activities (marketing programs in order to maximize profits and to satisfy customer’s and society’s needs at the required level. Marketing as a strategic and operational area, captures the interest of Romanian managers and specialists of international organizations, being a source of competitive advantage and positioning of the company and its portfolio brands, in the mind and soul of current and potential customers

  5. Cellular therapy injections in today's orthopedic market: A social media analysis.

    Science.gov (United States)

    Ramkumar, Prem N; Navarro, Sergio M; Haeberle, Heather S; Chughtai, Morad; Demetriades, Christopher; Piuzzi, Nicolas S; Mont, Michael A; Bauer, Thomas W; Muschler, George F

    2017-12-01

    The current state of cellular therapy for musculoskeletal conditions is at a crossroads. Marketing efforts are often outpacing clinical evidence and regulatory control. This study was an effort to describe the marketing of cellular therapy in musculoskeletal medicine by evaluating the content in popular social media channels. Specifically, media posts were evaluated for the following: (1) perspective, (2) tone, (3) content and (4) visibility. Social media content related to cell therapy for musculoskeletal conditions was assessed in a search using 28 hashtags on the public domains of Instagram and Twitter over a 2-year period (2014-2016) that resulted in analysis of 698 posts. Supplemental analyses of LinkedIn and Facebook domains were also conducted. A categorical scoring system was used to analyze perspective (patient, family or friend, business or organization), tone (positive, negative), content (education, advertisement, research, media coverage or patient experience) and visibility (number of hashtags per post). Sub-analyses of the advertisement content from various perspectives (patients, physicians and businesses) were performed. The media perspective was most frequently from a business or organization (83%; n = 575). A total of 94% of the posts had a positive tone and only 6% had a negative tone, and the only negative posts came from patients (60% positive and 40% negative). The most common content of social media posts were advertisements, representing 68% (n = 477) of all posts; this was confirmed in the Facebook analysis. The mean number of hashtags was five per post. Sub-analyses revealed approximately half of the advertising posts originated from a single business that recruited physicians to market their cell-based therapies on social media, which was confirmed in the LinkedIn analysis. The market messages related to cell-based therapies for musculoskeletal conditions available on social media are dominated by businesses that seem to use a

  6. Dutch guideline for clinical foetal-neonatal and paediatric post-mortem radiology, including a review of literature.

    Science.gov (United States)

    Sonnemans, L J P; Vester, M E M; Kolsteren, E E M; Erwich, J J H M; Nikkels, P G J; Kint, P A M; van Rijn, R R; Klein, W M

    2018-06-01

    Clinical post-mortem radiology is a relatively new field of expertise and not common practice in most hospitals yet. With the declining numbers of autopsies and increasing demand for quality control of clinical care, post-mortem radiology can offer a solution, or at least be complementary. A working group consisting of radiologists, pathologists and other clinical medical specialists reviewed and evaluated the literature on the diagnostic value of post-mortem conventional radiography (CR), ultrasonography, computed tomography (PMCT), magnetic resonance imaging (PMMRI), and minimally invasive autopsy (MIA). Evidence tables were built and subsequently a Dutch national evidence-based guideline for post-mortem radiology was developed. We present this evaluation of the radiological modalities in a clinical post-mortem setting, including MIA, as well as the recently published Dutch guidelines for post-mortem radiology in foetuses, neonates, and children. In general, for post-mortem radiology modalities, PMMRI is the modality of choice in foetuses, neonates, and infants, whereas PMCT is advised in older children. There is a limited role for post-mortem CR and ultrasonography. In most cases, conventional autopsy will remain the diagnostic method of choice. Based on a literature review and clinical expertise, an evidence-based guideline was developed for post-mortem radiology of foetal, neonatal, and paediatric patients. What is Known: • Post-mortem investigations serve as a quality check for the provided health care and are important for reliable epidemiological registration. • Post-mortem radiology, sometimes combined with minimally invasive techniques, is considered as an adjunct or alternative to autopsy. What is New: • We present the Dutch guidelines for post-mortem radiology in foetuses, neonates and children. • Autopsy remains the reference standard, however minimal invasive autopsy with a skeletal survey, post-mortem computed tomography, or post

  7. Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations

    Science.gov (United States)

    Turk, Dennis C.; O’Connor, Alec B.; Dworkin, Robert H.; Chaudhry, Amina; Katz, Nathaniel P.; Adams, Edgar H.; Brownstein, John S.; Comer, Sandra D.; Dart, Richard; Dasgupta, Nabarun; Denisco, Richard A.; Klein, Michael; Leiderman, Deborah B.; Lubran, Robert; Rappaport, Bob A.; Zacny, James P.; Ahdieh, Harry; Burke, Laurie B.; Cowan, Penney; Jacobs, Petra; Malamut, Richard; Markman, John; Michna, Edward; Palmer, Pamela; Peirce-Sandner, Sarah; Potter, Jennifer S.; Raja, Srinivasa N.; Rauschkolb, Christine; Roland, Carl L.; Webster, Lynn R.; Weiss, Roger D.; Wolf, Kerry

    2013-01-01

    Opioids are essential to the management of pain in many patients, but they also are associated with potential risks for abuse, overdose, and diversion. A number of efforts have been devoted to the development of abuse-deterrent formulations of opioids to reduce these risks. This article summarizes a consensus meeting that was organized to propose recommendations for the types of clinical studies that can be used to assess the abuse deterrence of different opioid formulations. Due to the many types of individuals who may be exposed to opioids, an opioid formulation will need to be studied in several populations using various study designs in order to determine its abuse-deterrent capabilities. It is recommended that the research conducted to evaluate abuse deterrence should include studies assessing: (1) abuse liability; (2) the likelihood that opioid abusers will find methods to circumvent the deterrent properties of the formulation; (3) measures of misuse and abuse in randomized clinical trials involving pain patients with both low risk and high risk of abuse; and (4) post-marketing epidemiological studies. PMID:22770841

  8. 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.

  9. 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.

  10. EU decision-making for marketing authorization of advanced therapy medicinal products: a case study.

    Science.gov (United States)

    de Wilde, Sofieke; Coppens, Delphi G M; Hoekman, Jarno; de Bruin, Marie L; Leufkens, Hubert G M; Guchelaar, Henk-Jan; Meij, Pauline

    2018-03-21

    A comparative analysis of assessment procedures for authorization of all European Union (EU) applications for advanced therapy medicinal products (ATMPs) shows that negative opinions were associated with a lack of clinical efficacy and identified severe safety risks. Unmet medical need was often considered in positive opinions and outweighed scientific uncertainties. Numerous quality issues illustrate the difficulties in this domain for ATMP development. Altogether, it suggests that setting appropriate standards for ATMP authorization in Europe, similar to elsewhere, is a learning experience. The experimental characteristics of authorized ATMPs urge regulators, industry, and clinical practice to pay accurate attention to post-marketing risk management to limit patient risk. Methodologies for ATMP development and regulatory evaluations need to be continuously evaluated for the field to flourish. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  11. From Academic to Post-Academic Science

    Directory of Open Access Journals (Sweden)

    Mohammad Amin Ghaneirad

    2014-03-01

    Full Text Available This paper studies the cultural change in science from academic science to post-academic science by the use of documentary studying and analytical reasoning. The aim of this study is determining the direction of cultural change in science and comparing it with cultural change in society.The knowledge production which surrounds academy has little relationship with the values of society and epistemological norms regulate scientists' behavior from within the scientific system. But in post-academic science the relationship between science and society operates in the same line with market and government and science produce within the social context and scientists' behavior controlled by the norms out of the scientific system. So the culture of science has changed because science applied to meet the requirements of market and industry. The result is that contrary to cultural change in society that goes from materialism to post-materialism, cultural change in science moves from post-materialism to materialism.

  12. 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…

  13. 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...

  14. The development of Facebook marketing utilizing Content marketing. Case: Pirjon Pakari Oy.

    OpenAIRE

    Lehtikangas, Pauliina

    2015-01-01

    The purpose of this thesis was to learn how to improve Pirjon Pakari Oy’s brand visibility and overall visibility on Facebook. This was done by trying to add value to the end customer by producing interesting and engaging posts to Pirjon Pakari Oy’s Facebook page. This case study utilized theory from content marketing in attempts to improve the marketing of “Pirjon” Facebook page and therefore a Facebook content marketing strategy was created for Pirjon Pakari Oy. This strategy was implemente...

  15. 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.

  16. Study on market policy

    International Nuclear Information System (INIS)

    2008-02-01

    In April 2007 the Dutch Minister of Economic Affairs promised the Lower House a study of the development of the public interests of quality, accessibility and efficiency after the introduction of market liberalization. In the debate on market liberalization in May 2007 the Minister complied with the Lower House?s request to include the consequences of the market liberalization operations on sectoral employment and labor conditions. This study addresses two questions: (1) Which developments occurred in the field of public interests quality, accessibility and efficiency and labor conditions since the introduction of market liberalization? and (2) What general findings and conclusions can be drawn from the implemented market liberalization policy in various sectors? What lessons can be learned for the future? Several sectors have been examined, including large energy users; renewable energy; energy market for medium users; energy (gas and electricity) [nl

  17. 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.

  18. 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.

  19. Selective Embolization for Post-Endoscopic Sphincterotomy Bleeding: Technical Aspects and Clinical Efficacy

    Energy Technology Data Exchange (ETDEWEB)

    So, Young Ho; Choi, Young Ho [Seoul National University Boramae Medical Center, Seoul (Korea, Republic of); Chung, Jin Wook; Jae, Hwan Jun; Park, Jae Hyung [Seoul National University Hospital, Seoul (Korea, Republic of); Song, Soon Young [Hanyang University Hospital, Seoul (Korea, Republic of)

    2012-01-15

    The objective of this study was to evaluate the technical aspects and clinical efficacy of selective embolization for post-endoscopic sphincterotomy bleeding. We reviewed the records of 10 patients (3%; M:F 6:4; mean age, 63.3 years) that underwent selective embolization for post-endoscopic sphincterotomy bleeding among 344 patients who received arteriography for nonvariceal upper gastrointestinal bleeding from 2000 to 2009. We analyzed the endoscopic procedure, onset of bleeding, underlying clinical condition, angiographic findings, interventional procedure, and outcomes in these patients. Among the 12 bleeding branches, primary success of hemostasis was achieved in 10 bleeding branches (83%). Secondary success occurred in two additional bleeding branches (100%) after repeated embolization. In 10 patients, post-endoscopic sphincterotomy bleedings were detected during the endoscopic procedure (n = 2, 20%) or later (n = 8, 80%), and the delay was from one to eight days (mean, 2.9 days; {+-} 2.3). Coagulopathy was observed in three patients. Eight patients had a single bleeding branch, whereas two patients had two branches. On the selective arteriography, bleeding branches originated from the posterior pancreaticoduodenal artery (n = 8, 67%) and anterior pancreaticoduodenal artery (n = 4, 33%), respectively. Superselection was achieved in four branches and the embolization was performed with n-butyl cyanoacrylate. The eight branches were embolized by combined use of coil, n-butyl cyanoacrylate, or Gelfoam. After the last embolization, there was no rebleeding or complication related to embolization. Selective embolization is technically feasible and an effective procedure for post-endoscopic sphincterotomy bleeding. In addition, the posterior pancreaticoduodenal artery is the main origin of the causative vessels of post-endoscopic sphincterotomy bleeding.

  20. Selective Embolization for Post-Endoscopic Sphincterotomy Bleeding: Technical Aspects and Clinical Efficacy

    International Nuclear Information System (INIS)

    So, Young Ho; Choi, Young Ho; Chung, Jin Wook; Jae, Hwan Jun; Park, Jae Hyung; Song, Soon Young

    2012-01-01

    The objective of this study was to evaluate the technical aspects and clinical efficacy of selective embolization for post-endoscopic sphincterotomy bleeding. We reviewed the records of 10 patients (3%; M:F 6:4; mean age, 63.3 years) that underwent selective embolization for post-endoscopic sphincterotomy bleeding among 344 patients who received arteriography for nonvariceal upper gastrointestinal bleeding from 2000 to 2009. We analyzed the endoscopic procedure, onset of bleeding, underlying clinical condition, angiographic findings, interventional procedure, and outcomes in these patients. Among the 12 bleeding branches, primary success of hemostasis was achieved in 10 bleeding branches (83%). Secondary success occurred in two additional bleeding branches (100%) after repeated embolization. In 10 patients, post-endoscopic sphincterotomy bleedings were detected during the endoscopic procedure (n = 2, 20%) or later (n = 8, 80%), and the delay was from one to eight days (mean, 2.9 days; ± 2.3). Coagulopathy was observed in three patients. Eight patients had a single bleeding branch, whereas two patients had two branches. On the selective arteriography, bleeding branches originated from the posterior pancreaticoduodenal artery (n = 8, 67%) and anterior pancreaticoduodenal artery (n = 4, 33%), respectively. Superselection was achieved in four branches and the embolization was performed with n-butyl cyanoacrylate. The eight branches were embolized by combined use of coil, n-butyl cyanoacrylate, or Gelfoam. After the last embolization, there was no rebleeding or complication related to embolization. Selective embolization is technically feasible and an effective procedure for post-endoscopic sphincterotomy bleeding. In addition, the posterior pancreaticoduodenal artery is the main origin of the causative vessels of post-endoscopic sphincterotomy bleeding.

  1. 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

  2. Maintaining the clinical relevance of animal models in translational studies of post-traumatic stress disorder.

    Science.gov (United States)

    Cohen, Hagit; Matar, Michael A; Zohar, Joseph

    2014-01-01

    The diagnosis of Post-Traumatic Stress Disorder (PTSD) is conditional on directly experiencing or witnessing a significantly threatening event and the presence of a certain minimal number of symptoms from each of four symptom clusters (re-experiencing, avoidance, negative cognition and mood, and hyperarousal) at least one month after the event (DSM 5) (American Psychiatric Association 2013). Only a proportion of the population exposed develops symptoms fulfilling the criteria. The individual heterogeneity in responses of stress-exposed animals suggested that adapting clearly defined and reliably reproducible "diagnostic", i.e. behavioral, criteria for animal responses would augment the clinical validity of the analysis of study data. We designed cut-off (inclusion/exclusion) behavioral criteria (CBC) which classify study subjects as being severely, minimally or partially affected by the stress paradigm, to be applied retrospectively in the analysis of behavioral data. Behavioral response classification enables the researcher to correlate (retrospectively) specific anatomic, bio-molecular and physiological parameters with the degree and pattern of the individual behavioral response, and also introduces "prevalence rates" as a valid study-parameter. The cumulative results of our studies indicate that, by classifying the data from individual subjects according to their response patterns, the animal study can more readily be translated into clinical "follow-up" studies and back again. This article will discuss the concept of the model and its background, and present a selection of studies employing and examining the model, alongside the underlying translational rationale of each. © The Author 2014. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  3. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial.

    Science.gov (United States)

    Krupp, L B; Hyman, L G; Grimson, R; Coyle, P K; Melville, P; Ahnn, S; Dattwyler, R; Chandler, B

    2003-06-24

    To determine whether post Lyme syndrome (PLS) is antibiotic responsive. The authors conducted a single-center randomized double-masked placebo-controlled trial on 55 patients with Lyme disease with persistent severe fatigue at least 6 or more months after antibiotic therapy. Patients were randomly assigned to receive 28 days of IV ceftriaxone or placebo. The primary clinical outcomes were improvement in fatigue, defined by a change of 0.7 points or more on an 11-item fatigue questionnaire, and improvement in cognitive function (mental speed), defined by a change of 25% or more on a test of reaction time. The primary laboratory outcome was an experimental measure of CSF infection, outer surface protein A (OspA). Outcome data were collected at the 6-month visit. Patients assigned to ceftriaxone showed improvement in disabling fatigue compared to the placebo group (rate ratio, 3.5; 95% CI, 1.50 to 8.03; p = 0.001). No beneficial treatment effect was observed for cognitive function or the laboratory measure of persistent infection. Four patients, three of whom were on placebo, had adverse events associated with treatment, which required hospitalization. Ceftriaxone therapy in patients with PLS with severe fatigue was associated with an improvement in fatigue but not with cognitive function or an experimental laboratory measure of infection in this study. Because fatigue (a nonspecific symptom) was the only outcome that improved and because treatment was associated with adverse events, this study does not support the use of additional antibiotic therapy with parenteral ceftriaxone in post-treatment, persistently fatigued patients with PLS.

  4. Premarket safety and efficacy studies for ADHD medications in children.

    Directory of Open Access Journals (Sweden)

    Florence T Bourgeois

    Full Text Available Attention-deficit hyperactivity disorder (ADHD is a chronic condition and pharmacotherapy is the mainstay of treatment, with a variety of ADHD medications available to patients. However, it is unclear to what extent the long-term safety and efficacy of ADHD drugs have been evaluated prior to their market authorization. We aimed to quantify the number of participants studied and their length of exposure in ADHD drug trials prior to marketing.We identified all ADHD medications approved by the Food and Drug Administration (FDA and extracted data on clinical trials performed by the sponsor and used by the FDA to evaluate the drug's clinical efficacy and safety. For each ADHD medication, we measured the total number of participants studied and the length of participant exposure and identified any FDA requests for post-marketing trials.A total of 32 clinical trials were conducted for the approval of 20 ADHD drugs. The median number of participants studied per drug was 75 (IQR 0, 419. Eleven drugs (55% were approved after <100 participants were studied and 14 (70% after <300 participants. The median trial length prior to approval was 4 weeks (IQR 2, 9, with 5 (38% drugs approved after participants were studied <4 weeks and 10 (77% after <6 months. Six drugs were approved with requests for specific additional post-marketing trials, of which 2 were performed.Clinical trials conducted for the approval of many ADHD drugs have not been designed to assess rare adverse events or long-term safety and efficacy. While post-marketing studies can fill in some of the gaps, better assurance is needed that the proper trials are conducted either before or after a new medication is approved.

  5. 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…

  6. [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.

  7. [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.

  8. 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.

  9. Clinical outcomes with the STENTYS self-apposing coronary stent in patients presenting with ST-segment elevation myocardial infarction: two-year insights from the APPOSITION III (A Post-Market registry to assess the STENTYS self-exPanding COronary Stent In AcuTe MyocardIal InfarctiON) registry.

    Science.gov (United States)

    Lu, Huangling; Grundeken, Maik J; Vos, Nicola S; IJsselmuiden, Alexander J J; van Geuns, Robert-Jan; Wessely, Rainer; Dengler, Thomas; La Manna, Alessio; Silvain, Johanne; Montalescot, Gilles; Spaargaren, René; Tijssen, Jan G P; Amoroso, Giovanni; de Winter, Robbert J; Koch, Karel T

    2017-08-04

    The APPOSITION III registry evaluated the feasibility and performance of the STENTYS self-apposing stent in an ST-segment elevation myocardial infarction (STEMI) population. This novel self-apposing stent device lowers stent strut malapposition rates and therefore carries the potential to prevent stent undersizing during primary percutaneous coronary intervention (PCI) in STEMI patients. To date, no long-term data are available using this device in the setting of STEMI. We aimed to evaluate the long-term clinical outcomes of the APPOSITION III registry. This was an international, prospective, multicentre post-marketing registry. The study population consisted of 965 STEMI patients. The primary endpoint, major adverse cardiac events (MACE), was defined as the composite of cardiac death, recurrent target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularisation (CD-TLR). At two years, MACE occurred in 11.2%, cardiac death occurred in 2.3%, TV-MI occurred in 2.3% and CD-TLR in 9.2% of patients. The two-year definite stent thrombosis (ST) rate was 3.3%. Incremental event rates between one- and two-year follow-up were 1.0% for TV-MI, 1.8% for CD-TLR, and 0.5% for definite ST. Post-dilation resulted in significantly reduced CD-TLR and ST rates at 30-day landmark analyses. Results were equivalent between the BMS and PES STENTYS subgroups. This registry revealed low rates of adverse events at two-year follow-up, with an incremental ST rate as low as 0.5% in the second year, demonstrating that the self-apposing technique is feasible in STEMI patients on long-term follow-up while using post-dilatation.

  10. Wind power and market integration, comparative study of financing schemes

    International Nuclear Information System (INIS)

    2013-10-01

    The financing scheme of renewable energies is a key factor for their development pace and cost. As some countries like France, Germany or Spain have chosen a Feed-in Tariff (FiT) scheme, there are in fact four possible financing schemes: FiT, ex-post prime, ex-ante prime, and quotas (green certificates). A market convergence is then supposed to meet two main objectives: the control of market distortions related to wind energy development, and the optimization of wind energy production with respect to market signals. The authors analyse the underlying economic challenges and the ability of financing schemes to meet these objectives within a short term horizon (2015). They present the different financing schemes, analyse the impact of three key economic factors (market distortion, production optimization, financing costs)

  11. How does crisis affect efficiency? An empirical study of East Asian markets

    Directory of Open Access Journals (Sweden)

    Syed Aun R. Rizvi

    2016-03-01

    Full Text Available Much research has been undertaken in the Efficient Market Hypothesis (EMH over the preceding two decades. With Asian countries emerging as a global powerhouse in terms of regional economics, the interest in their stock markets has picked up recently. Asian markets traditionally comprised of many emerging markets are generally assumed to be more volatile and speculative in nature. Based on this crux, we focus specifically on the response of these markets efficiency to major crisis. In recent years, the Asian markets have experienced a phenomenal boom in attracting foreign capital inflow, with Singapore evolving into a global financial hub in terms of banking and financial services. Scepticism and cautious nature raises the question of whether these stock markets are efficient enough for further investment and development. Our study is unique in nature, as we focus on the efficiency of these market in response to crisis periods, comparing it with their pre-crisis period, both in shorter term of 1 year as well as longer term of 5 years post and pre crisis period. Taking Malaysia, Indonesia, Singapore and South Korea owing to their economic and financial development, we use MF-DFA to derive efficiency measure for comparative analysis with its own past. The findings put forth a notion of generally a deteriorating and negative impact of the Asian financial crisis, while the sub-prime crisis impact varies based on the economic structure of the economies. The findings concur with the mainstream literature and similar studies for other countries and region.

  12. Canadian retail petroleum markets study

    International Nuclear Information System (INIS)

    Ervin, M.J.

    1998-02-01

    A retail petroleum market study was conducted to provide a comprehensive overview of the competitiveness of the downstream petroleum industry in Canada and to set a foundation for effective policy development. The downstream petroleum industry, which includes the petroleum refining and marketing sectors, faces a poor public image, competitive pressures from U.S. and offshore refiners, and a broad range of environmental challenges. In this study, 19 markets representing a wide range of conditions were chosen for a detailed review of outlet economics. A market-by-market and regional comparisons of key competitiveness indicators was made in order to identify market and regional competitive differences as potential issues or opportunities within the industry. The study also included a pump price/margin model and provided a general overview of the retail gasoline sub-sector in terms of infrastructure. A review of prices, margins and demand patterns over the past several years was also undertaken to show the relationship between consumer demand patterns and pump price fluctuations. The study presented 22 findings which led to several conclusions and recommendations regarding the competitiveness of Canada's petroleum marketing sector. Two of the key conclusions were that taxation is a significant factor in the price of retail gasoline (about 50 per cent) and that government intervention into petroleum marketing is likely to be a poor alternative to market-based regulation. 18 tabs., 37 figs

  13. Clinical bioethics in china: the challenge of entering a market economy.

    Science.gov (United States)

    Chen, Xiao-Yang

    2006-02-01

    Over the last quarter-century, China has experienced dramatic changes associated with its development of a market economy. The character of clinical practice is also profoundly influenced by the ways in which reimbursement scales are established in public hospitals. The market distortions that lead to the over-prescription of drugs and the medically unindicated use of more expensive drugs and more costly high-technology diagnostic and therapeutic interventions create the most significant threat to patients. The payment of red packets represents a black-market attempt to circumvent the non-market constraint on physicians' fees for services. These economic and practice pattern changes are taking place as China and many Pacific Rim societies are reconsidering the moral foundations of their professional ethics and their bioethics. The integrity of the medical profession and the trust of patients in physicians can only be restored and protected if the distorting forces of contemporary public policy are altered.

  14. 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.

  15. Post-SSRI Sexual Dysfunction: Preclinical to Clinical. Is It Fact or Fiction?

    Science.gov (United States)

    Coskuner, Enis Rauf; Culha, Mehmet Gokhan; Ozkan, Burak; Kaleagasi, Elcin Orhan

    2018-04-01

    Selective serotonin reuptake inhibitors (SSRIs) are a widely used class of drug for various psychiatric disorders during the lifespan, including pregnancy, lactation, childhood, and adolescence. Deterioration in sexual functioning is a major and serious adverse effect of SSRIs. There is emerging evidence that SSRIs can have long-lasting effects on sexuality. To summarize the long-lasting effects of SSRIs on sexuality, starting with animal models and continuing with the clinical experience of different investigators. A literature review of relevant publications in PubMed. To assess the long-lasting effects of SSRIs on sexuality. Although the persistent effects of SSRIs on sexuality have been little studied in humans, animal studies suggest that SSRIs might cause permanent sexual dysfunction after ending SSRI exposure at a young age but not in adulthood in rats. There are no prospective randomized controlled trials in humans and the present evidence is derived from case reports, incidental research findings, and experiences of some internet communities. There is some preclinical evidence from animal studies for enduring SSRI-induced sexual dysfunction, but the available clinical information could prevent a clear decision about the existence of post-SSRI sexual dysfunction, its pathophysiology, and its management. We need more research to fill in the gaps in our knowledge. Coskuner ER, Culha MG, Ozkan B, Kaleagasi EO. Post-SSRI Sexual Dysfunction: Preclinical to Clinical. Is It Fact or Fiction? Sex Med Rev 2018;6:217-223. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

  16. Junk Food Marketing on Instagram: Content Analysis.

    Science.gov (United States)

    Vassallo, Amy Jo; Kelly, Bridget; Zhang, Lelin; Wang, Zhiyong; Young, Sarah; Freeman, Becky

    2018-06-05

    Omnipresent marketing of processed foods is a key driver of dietary choices and brand loyalty. Market data indicate a shift in food marketing expenditures to digital media, including social media. These platforms have greater potential to influence young people, given their unique peer-to-peer transmission and youths' susceptibility to social pressures. The aim of this study was to investigate the frequency of images and videos posted by the most popular, energy-dense, nutrient-poor food and beverage brands on Instagram and the marketing strategies used in these images, including any healthy choice claims. A content analysis of 15 accounts was conducted, using 12 months of Instagram posts from March 15, 2015, to March 15, 2016. A pre-established hierarchical coding guide was used to identify the primary marketing strategy of each post. Each brand used 6 to 11 different marketing strategies in their Instagram accounts; however, they often adhered to an overall theme such as athleticism or relatable consumers. There was a high level of branding, although not necessarily product information on all accounts, and there were very few health claims. Brands are using social media platforms such as Instagram to market their products to a growing number of consumers, using a high frequency of targeted and curated posts that manipulate consumer emotions rather than present information about their products. Policy action is needed that better reflects the current media environment. Public health bodies also need to engage with emerging media platforms and develop compelling social counter-marketing campaigns. ©Amy Jo Vassallo, Bridget Kelly, Lelin Zhang, Zhiyong Wang, Sarah Young, Becky Freeman. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 05.06.2018.

  17. Connecting pre-marketing clinical research and medical practice : opinion-based study of core issues and possible changes in drug regulation

    NARCIS (Netherlands)

    Wieringa, N.F; Peschar, J.L.; Denig, P; de Graeff, P.A.; Vos, R

    2003-01-01

    Objectives: To identify core issues that contribute to the gap between pre-marketing clinical research and practice as seen from the perspective of medical practice, as well as possible changes and potential barriers for closing this gap. Methods: Interviews with 47 physicians and pharmacists who

  18. 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.

  19. [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.

  20. Electrophysiological studies in the post-viral fatigue syndrome.

    OpenAIRE

    Jamal, G A; Hansen, S

    1985-01-01

    Single fibre electromyography (SFEMG) was studied in 40 patients with the post-viral fatigue syndrome. These patients were also assessed clinically, serologically, virologically and immunologically. About 75% of the patients had definitely abnormal SFEMG results. This was regarded as evidence of abnormality in the peripheral part of the motor unit. The muscle fibre was the likely site of involvement.

  1. 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. 

  2. 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.

  3. 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

  4. 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

  5. Apartheid and post-apartheid intern clinical psychology training in South Africa.

    Science.gov (United States)

    Pillay, Anthony L

    2009-12-01

    An analysis of race and sex of clinical psychology interns was undertaken at a major training hospital complex during the Apartheid and Post-apartheid periods. 7 of 87 (8.1%) interns trained in the apartheid period were Black African. Significantly more Black Africans and women were trained during the Post-apartheid period. The results were discussed within the context of South Africa's social and political transition, as well as international trends relating to sex and professional psychology.

  6. Determinants of research use in clinical decision making among physical therapists providing services post-stroke: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Jaglal Susan B

    2010-10-01

    Full Text Available Abstract Background Despite evidence of the benefits of research use in post-acute stroke rehabilitation where compliance with clinical practice guidelines has been associated with functional recovery and patient satisfaction, the rate of reliance on the research literature in clinical decision making among physical therapists is low. More research examining factors that motivate physical therapists to consider research findings in neurological practice is needed to inform efforts to intervene. The objective of this study was to identify practitioner, organizational, and research characteristics associated with research use among physical therapists providing services post-stroke. Methods A cross-sectional mail survey of physical therapists providing services to people with stroke in Ontario, Canada was conducted. The survey questionnaire contained items to evaluate practitioner and organizational characteristics and perceptions of research considered to influence evidence-based practice (EBP, as well as the frequency of using research evidence in clinical decision making in a typical month. Ordinal regression was used to identify factors associated with research use. Results The percentage of respondents reporting research use in clinical decision making 0 to 1, 2 to 5, or 6+ times in a typical month was 33.8%, 52.9%, and 13.3%, respectively (n = 263. Academic preparation in the principles of EBP, research participation, service as a clinical instructor, self-efficacy to implement EBP, a positive attitude towards research, perceived organizational support of research use, and Internet access to bibliographic databases at work were each associated with research use and placed in the final regression model. In the final model (n = 244, academic preparation in EBP, EBP self-efficacy, agreement that research findings are useful, and research participation each remained significantly associated with research use after adjusting for the effects of

  7. Clinical and Molecular Characteristics of Post-Colonoscopy Colorectal Cancer: A Population-based Study.

    Science.gov (United States)

    Stoffel, Elena M; Erichsen, Rune; Frøslev, Trine; Pedersen, Lars; Vyberg, Mogens; Koeppe, Erika; Crockett, Seth D; Hamilton, Stanley R; Sørensen, Henrik T; Baron, John A

    2016-11-01

    Colonoscopy provides incomplete protection from colorectal cancer (CRC), but determinants of post-colonoscopy CRC are not well understood. We compared clinical features and molecular characteristics of CRCs diagnosed at different time intervals after a previous colonoscopy. We performed a population-based, cross-sectional study of incident CRC cases in Denmark (2007-2011), categorized as post-colonoscopy or detected during diagnostic colonoscopy (in patients with no prior colonoscopy). We compared prevalence of proximal location and DNA mismatch repair deficiency (dMMR) in CRC tumors, relative to time since previous colonoscopy, using logistic regression and cubic splines to assess temporal variation. Of 10,365 incident CRCs, 725 occurred after colonoscopy examinations (7.0%). These were more often located in the proximal colon (odds ratio [OR], 2.34; 95% confidence interval [CI], 1.90-2.89) and were more likely to have dMMR (OR, 1.26; 95% CI, 1.00-1.59), but were less likely to be metastatic at presentation (OR, 0.65; 95% CI, 0.48-0.89) compared with CRCs diagnosed in patients with no prior colonoscopy. The highest proportions of proximal and/or dMMR tumors were observed in CRCs diagnosed 3-6 years after colonoscopy, but these features were still more frequent among cancers diagnosed up to 10 years after colonoscopy. The relative excess of dMMR tumors was most pronounced in distal cancers. In an analysis of 85 cases detected after colonoscopy, we found BRAF mutations in 23% of tumors and that 7% of cases had features of Lynch syndrome. Colonoscopy exams were incomplete in a higher proportion of cases diagnosed within <1 year (in 38%) than in those diagnosed within 1-10 years after colonoscopy (16%). In a study of incident CRC cases in Denmark, we observed that tumors found in patients who have undergone colonoscopy are more often proximal and have dMMR compared to CRCs detected in patients without previous colonoscopies. The excess of right-sided tumors and

  8. 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…

  9. Clinical characteristics, risk factors and pre-surgical evaluation of post-infectious epilepsy.

    Science.gov (United States)

    Sellner, J; Trinka, E

    2013-03-01

    Epilepsy is a frequent complication of central nervous system (CNS) infections. Post-infectious epilepsy is commonly refractory to medical treatment and plays a pivotal role for the poor long-term outcome of CNS infections. To provide an overview of clinical characteristics and risk factors of seizures associated with CNS infections. In addition, to summarize the state of the art of anticonvulsive treatment and the pre-surgical evaluation process in refractory cases. A comprehensive literature search for articles published between January 1970 and December 2011 was carried out. The occurrence of seizures during the acute course of meningitis, encephalitis and brain abscess is the main risk factor for the development of post-infectious epilepsy. There is a shortage of trials evaluating the efficacy of prophylactic and symptomatic treatment during the course of acute infection. Moreover, there are no randomized-controlled trials studying anticonvulsive drugs and their combinations for the management of post-infectious epilepsy. In a selected group of patients, however, medically refractory focal epilepsy is potentially curable by surgery. Further studies are required to improve the pathogenetic understanding of post-infectious epilepsy in order to develop preventive measures as well as to evaluate additional medical and surgical treatment strategies for the patients currently not considered for surgery. © 2012 The Author(s) European Journal of Neurology © 2012 EFNS.

  10. A retrospective study of the clinical characteristics and post-treatment hearing outcome in idiopathic sudden sensorineural hearing loss

    Directory of Open Access Journals (Sweden)

    Purushothaman Ganesan

    2017-02-01

    Full Text Available The purpose of this retrospective study was to analyze the clinical characteristics and document hearing recovery in patients with idiopathic sudden sensorineural hearing loss (ISSNHL. 122 patients diagnosed with unilateral ISSNHL, from March 2009 to December 2014, were treated with oral steroids and pentoxifylline. Hearing change was evaluated by comparing pre-treatment and post-treatment pure-tone average (PTA (500, 1K, and 2K Hz, and categorized into complete, partial, and no recovery of hearing. T-test, Wilcoxon Signed Rank test and Regression analysis were employed to analyze the statistical significance. Of the 122 patients, seventy-one (58% had complete recovery and 34 (28% had partial recovery. The average pre-treatment PTA was 78.3 ± 16.9 dB whereas post-treatment average was 47.0 ± 20.8 dB, showing statistically significant improvement (t=24.89, P≤0.001. The factors such as presence of tinnitus (P=0.005 and initial milder hearing loss (P=0.005 were found to be significant predictors for hearing recovery. Conventional steroid regimes produced a recovery rate in ISSNHL, which exceeds the spontaneous recovery rate. The current study results highlight the importance of medical treatment in the management of ISSNHL.

  11. 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...

  12. 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...

  13. 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…

  14. Clinical Simulation in Psychiatric-Mental Health Nursing: Post-Graduation Follow Up.

    Science.gov (United States)

    Lilly, Mary LuAnne; Hermanns, Melinda; Crawley, Bill

    2016-10-01

    In psychiatric-mental health, creating an innovative strategy to help students learn content that may not be frequently seen in a clinical setting is challenging. Thus, simulation helps narrow this gap. Using Kirkpatrick and Kirkpatrick's model of evaluation to guide the current study, faculty contacted baccalaureate nursing program graduates who completed a psychiatric-mental health clinical simulation scenario featuring a hanging suicide and wrist cutting suicide attempt scenario in the "Behind the Door" series as part of the clinical component of their undergraduate psychiatric-mental health course. Eleven nurses responded to a survey regarding their post-graduate encounters with these types of clinical situations, and their perception of recall and application of knowledge and skills acquired during the simulation experience to the clinical situation. Nursing graduates' responses are expressed through three major themes: emotional, contextual/behavioral, and assessment outcomes. Data from the survey indicate that nursing graduates perceived the "Behind the Door" simulations as beneficial to nursing practice. This perception is important in evaluating knowledge transfer from a simulation experience as a student into application in nursing practice. [Journal of Psychosocial Nursing and Mental Health Services, 54(10), 40-45.]. Copyright 2016, SLACK Incorporated.

  15. Clinical endoscopic management and outcome of post-endoscopic sphincterotomy bleeding.

    Directory of Open Access Journals (Sweden)

    Wei-Chen Lin

    Full Text Available Post-endoscopic sphincterotomy bleeding is a common complication of biliary sphincterotomy, and the incidence varies from 1% to 48%. It can be challenging to localize the bleeder or to administer various interventions through a side-viewing endoscope. This study aimed to evaluate the risk factors of post-endoscopic sphincterotomy bleeding and the outcome of endoscopic intervention therapies. We retrospectively reviewed the records of 513 patients who underwent biliary sphincterotomy in Mackay Memorial Hospital between 2011 and 2016. The blood biochemistry, comorbidities, indication for sphincterotomy, severity of bleeding, endoscopic features of bleeder, and type of endoscopic therapy were analyzed. Post-endoscopic sphincterotomy bleeding occurred in 65 (12.6% patients. Forty-five patients had immediate bleeding and 20 patients had delayed bleeding. The multivariate analysis of risk factors associated with post-endoscopic sphincterotomy bleeding were liver cirrhosis (P = 0.029, end-stage renal disease (P = 0.038, previous antiplatelet drug use (P<0.001, and duodenal ulcer (P = 0.023. The complications of pancreatitis and cholangitis were higher in the bleeding group, with statistical significance. Delayed bleeding occurred within 1 to 7 days (mean, 2.5 days, and 60% (12/20 of the patients received endoscopic evaluation. In the delayed bleeding group, the successful hemostasis rate was 71.4% (5/7, and 65% (13/20 of the patients had ceased bleeding without endoscopic hemostasis therapy. Comparison of different therapeutic modalities showed that cholangitis was higher in patients who received epinephrine spray (P = 0.042 and pancreatitis was higher in patients who received epinephrine injection and electrocoagulation (P = 0.041 and P = 0.039 respectively. Clinically, post-endoscopic sphincterotomy bleeding and further endoscopic hemostasis therapy increase the complication rate of pancreatitis and cholangitis. Realizing the effectiveness of each

  16. 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

    decreases were reported in the Visual Analog Scale and the Shiratori’s severity scores (p<0.001. Conclusion: Oral nalfurafine hydrochloride (from 2.5 μg/day to a maximum of 5.0 μg/day continues to be safe and effective for the treatment of intractable pruritus in hemodialysis patients in real-world clinical settings. Keywords: post-marketing surveillance, safety, efficacy, nalfurafine hydrochloride, pruritus, hemodialysis

  17. A prospective randomized clinical study of the influence of primary closure or dressing on post-operative morbidity after mandibular third molar surgery

    Directory of Open Access Journals (Sweden)

    Peter E Egbor

    2014-01-01

    Full Text Available Objective: The aim of the following study is to determine the effect of primary closure or dressing on post-operative morbidity after impacted lower third molar surgery. Materials and Methods: This was a randomized clinical study of 72 patients who had surgical extraction of impacted mandibular third molars. The subjects were divided into two groups of A and B. Group A had total closure (primary closure and Group B had whitehead varnish dressing of the socket. Pain, swelling and trismus were evaluated pre-operatively using visual analogue scale, flexible tape measuring method and inter-incisal distance measurement with Vernier Callipers respectively as well as post-operatively on 1 st , 2 nd , 3 rd , 5 th and 7 th day. Results: The study participants consisted of 27 males and 45 females in a ratio 1:1.7. With a mean age of 24.7 ± 4.9 years (range 19-33 years for Group A and 25.5 ± 4.3 years (range 20-39 years for Group B. Post-operative pain was not significantly affected by the closure techniques (P > 0.05. Dressing was found to significantly reduce the degree of swelling and trismus peaking on the 2 nd day (P = 0.0207 and P = 0.010 respectively. Conclusion: The use of dressing was more effective than primary closure to reduce the degree of swelling and trismus though its effect on post-operative pain reduction was not significant.

  18. Information seeking-pattern of Nigerian textile market women and ...

    African Journals Online (AJOL)

    The study investigated the information seeking-pattern of Nigerian textile market women and strategies for improvement of which the study was an ex-post-facto type and adopted survey research design. Disproportional stratified random technique was used to select markets for the study while questionnaire was used to ...

  19. Market Sanitation: A Case Study of Oregbeni Market Benin - City ...

    African Journals Online (AJOL)

    Poor market sanitation is an intractable problem in Nigeria and has contributed to the spread of infectious diseases and environmental degradation. This study was undertaken to determine the awareness and practice of solid waste management in market places among market users. It involved 180 store owners and ...

  20. Designing a Marketing Analytics Course for the Digital Age

    Science.gov (United States)

    Liu, Xia; Burns, Alvin C.

    2018-01-01

    Marketing analytics is receiving great attention because of evolving technology and the radical changes in the marketing environment. This study aims to assist the design and implementation of a marketing analytics course. We assembled a rich data set from four sources: business executives, 400 employers' job postings, one million tweets about…

  1. Empirical Studies on Financial Markets: Private Equity, Corporate Bonds and Emerging Markets

    NARCIS (Netherlands)

    G.J. de Zwart (Gerben)

    2008-01-01

    textabstractThis dissertation consists of five empirical studies on financial markets. Each study can be read independently and covers a specific market, either private equity, corporate bonds or emerging markets. The first study documents that risk factors cannot account for the significant excess

  2. An Analytical Study of Tools and Techniques for Movie Marketing

    Directory of Open Access Journals (Sweden)

    Garima Maik

    2014-08-01

    Full Text Available Abstract. Bollywood or Hindi movie industry is one of the fastest growing sector in the media and entertainment space creating numerous business and employment opportunities. Movies in India are a major source of entertainment for all sects of society. They not only face competition from other movie industries and movies but from other source of entertainment such as adventure sports, amusement parks, theatre and drama, pubs and discothèques. A lot of man power, man hours, creative brains, and money are put in to build a quality feature film. Bollywood is the industry which continuously works towards providing the 7 billion population with something new always. So it is important for the movie and production team to stand out, to grab the due attention of the maximum audience. Movie makers employ various tools and techniques today to market their movies. They leave no stone unturned. They roll out teasers, First look, Theatrical trailer release, Music launch, City tours, Producer’s and director’s interview, Movie premier, Movie release, post release follow up and etc. to pull the viewers to the Cineplex. The audience today which comprises mainly of youth requires photos, videos, meet ups, gossip, debate, collaboration and content creation. These requirements of today’s generation are most fulfilled through digital platforms. However, the traditional media like newspapers, radio, and television are not old school. They reach out to mass audience and play an upper role in effective marketing. This study aims at analysing these tools for their effectiveness. The objectives are fulfilled through a consumer survey. This study will bring out the effectiveness and relational importance of various tools which are employed by movie marketers to generate maximum returns on the investments by using various data reduction techniques like factor analysis and statistical techniques like chi-square test with data visualization using pie charts

  3. MARKETING STUDIES OF VETERINARY PHARMACY ORGANIZATIONS ASSORTMENT

    Directory of Open Access Journals (Sweden)

    A. A. Deltsov

    2015-01-01

    Full Text Available Nowadays there is an active growth of veterinary pharmacy organizations and consumed medicinal drugs for veterinary use. Content-analysis showed that there was an insufficient number of studies devoted to the activity of veterinary pharmacies. The purpose of our work was the analysis of correspondence of range fullness of veterinary pharmacies to the contemporary state of pharmaceutical market of drugs for veterinary use. Veterinary clinics and pharmacies of Moscow and Moscow oblast were the object of our study. We have applied sociological methods (questionnaire, interview, marketing and statistic analysis methods. We have established that liquid dosage forms (53% occupy the biggest part of drugs in the State Registry of Veterinary Drugs. Solutions occupy 68% of this amount. Antimicrobial drugs for systematic use (40% are the most numerous drugs from pharmacotheraperutic group represented in the State Registry. Assortment of veterinary drugs is targeted mainly on a farm livestock (more than 50%. 58% of the market share is domestic drugs. Principal commodity groups which are released by veterinary pharmacies are feed-stuff (31% and drugs (30%. Pharmacy organizations does not have sufficient number of drugs in their assortment (fullness coefficient 7.9% which speaks about nonconformity of the assortment fullness.

  4. [The post-discectomy syndrome: clinical and electroneuromyographic characteristics and methods of treatment].

    Science.gov (United States)

    Musaev, A V; Guseĭnova, S G; Musaeva, I R

    2008-01-01

    The data of the Azerbaijan Neurosurgical Center, including 2618 case-reports of patients operated on for low back discal hernia between 1997 and 2002, have been analyzed. The retrospective analysis of the data reveals that 26,4% of patients need further restorative treatment due to the presence of various neurological disturbances: pain syndromes of different intensity, motor deficits (pareses), sensory disorders and functional disorders of pelvic organs. The retrospective analysis of the data reveals that 26,4% of patients need further restorative treatment due to the presence of various neurological disturbances: pain syndromes of different intensity, motor deficits (pareses), sensory disorders and functional disorders of pelvic organs. Along with these data, the results of our own clinical and neurophysiological study of 110 patients have been summarized as well. Along with these data, the results of our own clinical and neurophysiological study of 110 patients have been summarized as well. A high effectiveness of electrostimulation and naphthalan therapy alone and in combination with massage and medical gymnastics has been revealed. A high effectiveness of electrostimulation and naphthalan therapy alone and in combination with massage and medical gymnastics has been revealed. Electroneuromyographic data revealing the positive dynamics as a result of the treatment of patients with the post-discectomy syndrome are presented. Electroneuromyographic data revealing the positive dynamics as a result of the treatment of patients with the post-discectomy syndrome are presented.

  5. Identifying clinically relevant drug resistance genes in drug-induced resistant cancer cell lines and post-chemotherapy tissues.

    Science.gov (United States)

    Tong, Mengsha; Zheng, Weicheng; Lu, Xingrong; Ao, Lu; Li, Xiangyu; Guan, Qingzhou; Cai, Hao; Li, Mengyao; Yan, Haidan; Guo, You; Chi, Pan; Guo, Zheng

    2015-12-01

    Until recently, few molecular signatures of drug resistance identified in drug-induced resistant cancer cell models can be translated into clinical practice. Here, we defined differentially expressed genes (DEGs) between pre-chemotherapy colorectal cancer (CRC) tissue samples of non-responders and responders for 5-fluorouracil and oxaliplatin-based therapy as clinically relevant drug resistance genes (CRG5-FU/L-OHP). Taking CRG5-FU/L-OHP as reference, we evaluated the clinical relevance of several types of genes derived from HCT116 CRC cells with resistance to 5-fluorouracil and oxaliplatin, respectively. The results revealed that DEGs between parental and resistant cells, when both were treated with the corresponding drug for a certain time, were significantly consistent with the CRG5-FU/L-OHP as well as the DEGs between the post-chemotherapy CRC specimens of responders and non-responders. This study suggests a novel strategy to extract clinically relevant drug resistance genes from both drug-induced resistant cell models and post-chemotherapy cancer tissue specimens.

  6. 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...

  7. 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.

  8. Drug development: from concept to marketing!

    Science.gov (United States)

    Tamimi, Nihad A M; Ellis, Peter

    2009-01-01

    Drug development is an expensive, long and high-risk business taking 10-15 years and is associated with a high attrition rate. It is driven by medical need, disease prevalence and the likelihood of success. Drug candidate selection is an iterative process between chemistry and biology, refining the molecular properties until a compound suitable for advancing to man is found. Typically, about one in a thousand synthesised compounds is ever selected for progression to the clinic. Prior to administration to humans, the pharmacology and biochemistry of the drug is established using an extensive range of in vitro and in vivo test procedures. It is also a regulatory requirement that the drug is administered to animals to assess its safety. Later-stage animal testing is also required to assess carcinogenicity and effects on the reproductive system. Clinical phases of drug development include phase I in healthy volunteers to assess primarily pharmacokinetics, safety and toleration, phase II in a cohort of patients with the target disease to establish efficacy and dose-response relationship and large-scale phase III studies to confirm safety and efficacy. Experience tells us that approximately only 1 in 10 drugs that start the clinical phase will make it to the market. Each drug must demonstrate safety and efficacy in the intended patient population and its benefits must outweigh its risks before it will be approved by the regulatory agencies. Strict regulatory standards govern the conduct of pre-clinical and clinical trials as well as the manufacturing of pharmaceutical products. The assessment of the new medicinal product's safety continues beyond the initial drug approval through post-marketing monitoring of adverse events. Copyright 2009 S. Karger AG, Basel.

  9. [Comparison of clinical effects of Co-Cr alloy cast post-core and everStick fiber post in restoration of labially or lingually inclined maxillary central incisor].

    Science.gov (United States)

    Qian, Yu-Mei; Zhong, Qun; Chen, Shuang

    2017-02-01

    To compare the clinical effect of Co-Cr alloy cast post-core and everStick fiber post in restoration of maxillary central incisor with labial or lingual inclination, and provide theoretical basis for clinical application. Ninety-seven labially or lingually inclined maxillary central incisors were treated in our hospital from March 2012 to March 2014. The patients were randomly divided into group A (n=49) and group B (n=48), and received post -core and crown restoration. Patients in group A underwent Co-Cr alloy cast post and core restoration and patients in group B underwent everStick fiber post and core restoration. After two-year of follow-up, root fracture, post break, crown or post dislodgment and gingival marginal discoloration were recorded and analyzed using SPSS 19.0 software package. Chi-square test showed that the success rate of restoration was significantly different between 2 groups (P<0.05). The incidence of root fracture and gingival marginal discoloration of Co-Cr alloy cast post-core was higher than that of everStick fiber post, but there was no significant difference in the incidence of post break, crown or post dislodgment. EverStick fiber post is better than Co-Cr alloy cast post and core to prevent root fracture and gingival marginal discoloration. Its fracture pattern is repairable and favorable for preserving tooth.

  10. Post-use assay of vaginal rings (VRs) as a potential measure of clinical trial adherence.

    Science.gov (United States)

    Spence, Patrick; Nel, Annalene; van Niekerk, Neliëtte; Derrick, Tiffany; Wilder, Susan; Devlin, Bríd

    2016-06-05

    Adherence measurement for microbicide use within the clinical trial setting remains a challenge for the HIV prevention field. This paper describes an assay method used for determining residual dapivirine levels in post-use vaginal rings from clinical trials conducted with the Dapivirine Vaginal Matrix Ring-004 developed by the International Partnership for Microbicides to prevent male to female HIV transmission. Post-use assay results from three Ring-004 clinical trials showed that of the 25mg drug load, approximately 4mg of dapivirine is released from the matrix ring over a 28-day use period. Data obtained by both in vitro and in vivo studies indicate that dapivirine is released according to a diffusion mechanism, as determined by conformance of both data sets to the Higuchi equation. This, coupled with the low variability associated with batch production over two manufacturing sites and 20 batches of material, provides evidence that post-use ring analysis can contribute to the assessment of adherence to ring use. Limitations of this method include the potential of intra-participant and inter-participant variability and uncertainty associated with measuring the low amount of dapivirine actually released relative to the drug load. Therefore, residual drug levels should not serve as the only direct measurement for microbicide adherence in vaginal ring clinical trials but should preferably be used as part of a multi-pronged approach towards understanding and assessing adherence to vaginal ring use. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

  11. Influence of Using Clinical Microscope as Auxiliary to Perform Mechanical Cleaning of Post Space: A Bond Strength Analysis.

    Science.gov (United States)

    Ferreira, Ricardo; Prado, Maíra; de Jesus Soares, Adriana; Zaia, Alexandre Augusto; de Souza-Filho, Francisco José

    2015-08-01

    The aim of the present study was to evaluate the influence of using a clinical microscope while performing mechanical cleaning of post space walls on the bond strength of a fiberglass post to dentin. Forty-five bovine roots were used. After preparation, roots were filled using gutta-percha and Pulp Canal Sealer (SybronEndo, Orange, CA). Subsequently, for post space preparation, the roots were divided into 3 groups: control (only heat condenser + specific bur of the post system); cleaning without a microscope, mechanical cleaning (after the procedure described in the control group, round burs were used to improve cleaning); and cleaning with a microscope, mechanical cleaning performed with round burs visualized under a clinical microscope. Then, fiberglass posts were cemented. The roots were prepared and evaluated by the push-out test. Data were analyzed using Kruskal-Wallis and Student-Newman-Keuls tests (P microscope (cervical 1.66 ± 2.3, middle 0.65 ± 1.1, apical 0.79 ± 1.2, and total1.04 ± 1.7), and cleaning with a microscope (cervical 3.26 ± 2.8, middle 1.97 ± 3.5, apical 1.85 ± 4.1, and total 2.37 ± 3.5). In the cleaning with a microscope group, the bond strength values were significantly higher than those in the other groups. In all groups, the main failure pattern was adhesive between cement and dentin. The use of a clinical microscope while performing mechanical cleaning during post space preparation improved the bond strength of a fiberglass post to dentin. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  12. Being Critical in Marketing Studies

    DEFF Research Database (Denmark)

    Dholakia, Nikilesh

    2012-01-01

    review the research spaces for critical studies of marketing in various global settings and conclude that United Kingdom and Nordic Europe have the best epistemic climate, and this region needs to take leadership in promoting greater range of macro and critical studies of marketing in the rest......In this article, I argue that an elevated macro-level perspective is imperative for conducting critical studies in the fields of marketing and consumer research. There are epistemic barriers to operating in this manner, and I offer several suggestions for overcoming these barriers. Finally, I...

  13. Ahmed glaucoma valve in post-penetrating-keratoplasty glaucoma: A critically evaluated prospective clinical study

    Science.gov (United States)

    Panda, Anita; Prakash, Vadivelu Jaya; Dada, Tanuj; Gupta, Anoop Kishore; Khokhar, Sudarshan; Vanathi, Murugesan

    2011-01-01

    Aim: The aim was to evaluate the outcome of Ahmed glaucoma valve (AGV) in post-penetrating-keratoplasty glaucoma (PKPG). Materials and Methods: In this prospective study, 20 eyes of 20 adult patients with post-PKPG with intraocular pressure (IOP) >21 mmHg, on two or more antiglaucoma medications, underwent AG (model FP7) implantation and were followed up for a minimum of 6 months. Absolute success was defined as 5 glaucoma managed by AGV implantation revealed a satisfactory outcome up to 6 months of follow-up. PMID:21586837

  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. THE STRATEGIC RESPONSE OF SMALL AND MEDIUM-SIZED ENTERPRISE SECTOR FIRMS TO THE SINGLE EUROPEAN MARKET - A COMPARATIVE STUDY

    OpenAIRE

    BRICKAU, RALF ALEXANDER

    1994-01-01

    The creation of the post-1992 European Single Market represents a significant change in the business environment confronting firms throughout Europe. Although there is an extensive source of literature available on appropriate strategic responses to the Single Market, very few of these writings contain guidance specifically related to the situation facing small and medium- sized enterprises (SMEs). The objectives of this study are i) to determine important veu-iables which m...

  16. Patient retention at dental school clinics: a marketing perspective.

    Science.gov (United States)

    Makarem, Suzanne C; Coe, Julie M

    2014-11-01

    The purpose of this investigation was to examine the drivers of patient retention at dental school clinics from a services marketing perspective. An analysis of patient characteristics at Virginia Commonwealth University School of Dentistry, screened between August 2010 and July 2011 (N=3604), was performed using descriptive statistics, cross-tabulations, and a binary logistic regression. The main findings were that 42 percent of patients in the study were retained and that no response to communication efforts (36 percent) and financial problems (28 percent) constituted the most common reasons for non-retention. Older age, having insurance, and living within a sixty-mile radius were significant drivers of retention (pskills to better service them, and consequently increasing retention. This will lead to providing a continuum of care and student education and to ensuring the sustainability and quality of the school's educational programs.

  17. Temporal changes in clinic and ambulatory blood pressure during cyclic post-menopausal hormone replacement therapy

    DEFF Research Database (Denmark)

    Sørensen, M B; Rasmussen, Verner; Jensen, Gorm Boje

    2000-01-01

    OBJECTIVE: Post-menopausal hormone replacement (HRT) might protect against cardiovascular disease, possibly by arterial vasodilation and reduced blood pressure. Progestogens are needed to avoid endometrial disease but vascular effects are controversial. The objective was to assess temporal changes...... in blood pressure (BP) by two measurement techniques during a cyclic hormone replacement regimen. DESIGN AND METHODS: Sixteen healthy and normotensive post-menopausal women (age 55 +/- 3 years) were studied in a placebo-controlled, randomized crossover study, and were randomized to 17beta-oestradiol plus...... and in the ninth weeks of treatment in both periods. RESULTS: Clinic systolic and diastolic BP were reduced after 10 days of oestradiol (-5.1 and -3.2 mmHg respectively, P

  18. How can cardiothoracic and vascular medical devices stay in the market?

    Science.gov (United States)

    Wong, Kathie A; Hodgson, Luke; Garas, George; Malietzis, George; Markar, Sheraz; Rao, Christopher; von Segesser, Ludwig K; Athanasiou, Thanos

    2016-12-01

    Surgeons, as the consumers, must engage in commercial activity regarding medical devices since it directly has impacts on surgical practice and patient outcomes. Unique features defy traditional economic convention in this specific market partly because consumers do not usually pay directly. Greater involvement with commercial activity means better post-market surveillance of medical devices which leads to improved patient safety. The medical device industry has exhibited astonishing levels of growth and profitability reaching $398 billion on a global scale with new product development focusing on unmet clinical need. The industry has rapidly emerged within the context of an ageing population and a global surge in healthcare spending. But the market remains fragmented. The split of consumer, purchaser and payer leads to clinical need driving demand for new product development. This demand contributes to potentially large profit margins mainly contained by regulatory burden and liability issues. Demographic trends, prevalence of diseases and a huge capacity to absorb technology have sustained near unparalleled growth. To stay in the market, incremental development over the short term is essentially aided by responsiveness to demand. Disruptive product development is now more likely to come from multinational companies, in an increasingly expensive, regulated industry. Understanding healthcare organization can help explain the highly complex process of diffusion of innovations in healthcare that include medical devices. The time has come for surgeons to become actively involved with all aspects of the medical device life cycle including commercial activity and post-market surveillance. This is vital for improving patient care and ensuring patient safety. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  19. Comparative Study of Professional vs Mass Market Topical Products for Treatment of Facial Photodamage.

    Science.gov (United States)

    Reich, Hilary; Wallander, Irmina; Schulte, Lacie; Goodier, Molly; Zelickson, Brian

    2016-01-01

    Many over the counter topical products claim to reverse the signs of cutaneous photo-damage. To date, the two most studied ingredients for improving the texture, tone, and pigmentation of the skin are topical retinoids and hydroquinone. This split face study compares a mass market skincare regimen with a prescription skin care regimen for improvement in photo damaged skin. Twenty-seven subjects with moderate photo damaged facial skin were enrolled. Each subject was consented and assigned with the mass market anti-aging system (Treatment A) to one side of the face and the prescription anti-aging system (Treatment B or Treatment C) to the other side of the face. Treatment B contained 13 subjects whom did not use 0.025% Retinol cream. Treatment C contained 14 subjects who used a 0.025% Retinol Cream. Subjects had 4 visits over 12 weeks for digital photography and surveys. Photographs were evaluated by blinded physicians. Physician objective analysis showed all three systems to have a statistically significant clinical improvement in photoaged skin seen in as little as 4 weeks of use. Participant's surveys rated the mass market system higher than both of the professional systems for visible skin changes, ease of use, and likelihood to recommend to a friend. Twelve of twenty-seven subjects preferred the mass market system for overall improvement while twelve thought each system gave the same improvement. This study demonstrates that a mass marketed skin care system can give similar clinical improvements in photo-aged skin as a professionally dispensed prescription system and the majority of participants preferred the mass-marketed system.

  20. Clinical utility of marketing terms used for over-the-counter dermatologic products.

    Science.gov (United States)

    Boozalis, Emily; Patel, Shivani

    2018-05-08

    Cosmetic products are commonly marketed using dermatologic terms such as 'hypoallergenic', 'non-comedogenic', 'fragrance-free', etc. The clinical relevance of these claims can be confusing to both patients and clinicians. A systematic review was performed via a PubMed search of published articles from January 1985 to October 2017 to further describe and elucidate the clinical utility of a predefined list of common dermatologic terms used by pharmaceutical companies to market over-the-counter products. The terms 'fragrance-free', 'hypoallergenic', 'non-comedogenic', and 'oil-free' on cosmetic product labels are not regulated by any governing body and provide varied clinical utility. Products labeled as having 'natural ingredients' are not necessarily safer or less irritating to patients with atopy or a history of allergic contact dermatitis. Despite the increasing popularity of 'paraben-free' cosmetics, parabens are safe for patients in the quantities used in cosmetic products and can be safely used in patients who do not exhibit contact dermatitis to this preservative. A working knowledge of common cosmetic ingredients may help dermatologists to counsel patients on which products to avoid for their specific dermatologic conditions.

  1. 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”.

  2. Practice databases and their uses in clinical research.

    Science.gov (United States)

    Tierney, W M; McDonald, C J

    1991-04-01

    A few large clinical information databases have been established within larger medical information systems. Although they are smaller than claims databases, these clinical databases offer several advantages: accurate and timely data, rich clinical detail, and continuous parameters (for example, vital signs and laboratory results). However, the nature of the data vary considerably, which affects the kinds of secondary analyses that can be performed. These databases have been used to investigate clinical epidemiology, risk assessment, post-marketing surveillance of drugs, practice variation, resource use, quality assurance, and decision analysis. In addition, practice databases can be used to identify subjects for prospective studies. Further methodologic developments are necessary to deal with the prevalent problems of missing data and various forms of bias if such databases are to grow and contribute valuable clinical information.

  3. 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...

  4. Microbicide clinical trial adherence: insights for introduction.

    Science.gov (United States)

    Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena

    2013-04-08

    After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

  5. Post-ERCP infection and its epidemiological and clinical characteristics in a large Chinese tertiary hospital: a 4-year surveillance study

    Directory of Open Access Journals (Sweden)

    Mingmei Du

    2017-12-01

    Full Text Available Abstract Background Endoscopic retrograde cholangiopancreatography (ERCP is widely performed as a treatment for biliary and pancreatic illness in China; however, there are few data available regarding post-ERCP infections. This study aimed to describe the overall incidence of post-ERCP infections and the epidemiological characteristics of infected patients in a large tertiary-care hospital in China. Methods Real-time surveillance was performed from 2012 through 2015 to identify all healthcare-associated infections (HAIs that occurred after ERCP, using an automatic system. All HAIs (e.g., cholangtitis, bacteremia were identified by infection control practitioners and doctors. Inpatient data were automatically collected by the surveillance system. Results A total of 1743 ERCP operations were included in the study, among these, 132 (7.57% HAIs were identified. ERCP postoperative infections occurred following different surgical procedures, with infection rates ranging from 3.58 to 13.51%. The most prevalent HAI was biliary tract infection (4.02%, followed by transient bacteremia (1.14%. Overall, 62 cases of bacteremia occurred following ERCP surgery and 34 (54.84% cases occurred on the day of the operation or 1-day post-surgery. The most prevalent isolates detected during bacteremia were Enterococcus faecium (12/58 and Escherichia coli (11/58. A large proportion (72.73% of the E. coli isolates and all of the E. faecium isolates were resistant to ciprofloxacin. In addition, only 37.50% of the E. coli isolates were susceptible to ceftriaxone. Conclusions The high incidence of post-ERCP infection and the prevalence of drug resistance suggests that employing second generation cephalosporin or ceftriaxone as the antibiotic of choice for prophylaxis before ERCP, as recommended by the Chinese clinical application of antibacterial drugs guidelines, may not be effective.

  6. 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.

  7. Clinical Significance of Diffuse Intrathoracic Uptake on Post-Therapy I-131 Scans in Thyroid Cancer Patients

    International Nuclear Information System (INIS)

    Choi, Hyun Su; Kim, Sung Hoon; Park, Sonya Youngju; Park, Hye Lim; Seo, Ye Young; Choi, Woo Hee

    2014-01-01

    The purpose of this study was to identify the frequency and possible cause of diffuse intrathoracic uptake on post-therapy I-131 scans in thyroid cancer patients. We retrospectively reviewed 781 post-therapy scans of 755 thyroid cancer patients who underwent total thyroidectomy and radioactive iodine therapy between January and December 2010. Diffuse intrathoracic uptake on post-therapy scans was examined, and clinical patient characteristics including sex, age, regimen for thyroid-stimulating hormone (TSH) stimulation (thyroid hormone withdrawal or recombinant human TSH injection), TSH, thyroglobulin (Tg) and anti-thyroglobulin antibody (anti-Tg Ab) levels, therapeutic dose of radioactive iodine therapy and prior history of radioactive iodine therapy were recorded.Scan findings were correlated with chest CT, chest radiographs, laboratory tests and/or clinical status. Diffuse intrathoracic uptake without evidence of pathologic condition was categorized as indeterminate. The association between clinical characteristics and intrathoracic uptake were analyzed for negative intrathoracic uptake and indeterminate uptake groups. Diffuse intrathoracic uptake on post-therapy scans was demonstrated in 39 out of 755 (5.2 %) patients, among which 3 were confirmed as lung metastasis. The 14 patients that showed high Tg or anti-Tg Ab levels were considered to be at risk of having undetected micrometastasis on other imaging modalities. The remaining 22 were indeterminate (2.9 %). Upon comparison of negative intrathoracic uptake and indeterminate uptake groups, TSH stimulation by thyroid hormone withdrawal was shown to be significantly correlated with diffuse intrathoracic uptake (p <0.05). The frequency of diffuse intrathoracic uptake on post-therapy scans was 5.2 % and could be seen in thyroid cancer patients with underlying lung metastasis as well as those without definite pathologic condition. In the latter, there was a higher frequency for diffusely increased intrathoracic

  8. 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.

  9. 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

  10. Clinical Utility of SPECT/CT Imaging Post-Radioiodine Therapy: Does It Enhance Patient Management in Thyroid Cancer?

    Science.gov (United States)

    Hassan, Fahim U; Mohan, Hosahalli K

    2015-12-01

    The aim of this study was to evaluate post-therapy iodine-131 single-photon emission computed tomography/computed tomography ((131)I-SPECT/CT) imaging in comparison to conventional planar (131)I whole-body imaging, and to assess its clinical impact on the management of patients. We retrospectively reviewed planar (131)I whole-body and (131)I-SPECT/CT imaging findings in 67 patients who underwent (131)I therapy for thyroid cancer. Two nuclear medicine physicians reviewed the scans independently. The foci of increased tracer uptake were identified in the neck, thorax and elsewhere. Within the neck, the foci of (131)I-increased uptake were graded qualitatively as probable or definite uptake in thyroid remnants and probable or definite uptake in the lymph nodes. Serum thyroglobulin level, histopathology and other imaging findings served as the reference standard. Of the 67 patients, 57 (85%) had radioiodine avid disease and 10 (15%) demonstrated non-radioiodine avid disease. Overall, post-therapy (131)I-SPECT/CT downstaged lymph node staging in 10 patients and upstaged it in 4 patients. This translated into a change of management for 9/57 (16%) patients with radioiodine avid disease. A change of management was observed in 5/10 patients with non-radioiodine avid disease confirmed in the post-(131)I-SPECT/CT study. Additionally, clinically significant findings such as incidental lung cancer, symptomatic pleural effusion and consolidation were also diagnosed in both groups of patients. In patients with thyroid cancer, (131)I-SPECT/CT is a valuable addition to standard post-therapy planar imaging. SPECT/CT also improved diagnostic confidence and provided crucial clinical information leading to change of management for a significant number of these patients.

  11. 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

  12. [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.

  13. Do Simulation-Based Skill Exercises and Post-Encounter Notes Add Additional Value to a Standardized Patient-Based Clinical Skills Examination?

    Directory of Open Access Journals (Sweden)

    Michael D. Prislin

    2011-01-01

    Full Text Available Background. Standardized patient (SP clinical assessments have limited utility in assessing higher-level clinical competencies. This study explores the value of including simulation exercises and postencounter notes in an SP clinical skills examination. Methods. Two exercises involving cardiac auscultation and ophthalmic funduscopy simulations along with written post encounter notes were added to an SP-based performance examination. Descriptive analyses of students' performance and correlations with SP-based performance measures were obtained. Results. Students' abilities to detect abnormalities on physical exam were highly variable. There were no correlations between SP-based and simulation-derived measures of physical examination competency. Limited correlations were found between students' abilities to perform and document physical examinations and their formulation of appropriate differential diagnoses. Conclusions. Clinical simulation exercises add depth to SP-based assessments of performance. Evaluating the content of post encounter notes offers some insight into students' integrative abilities, and this appears to be improved by the addition of simulation-based post encounter skill exercises. However, further refinement of this methodology is needed.

  14. 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…

  15. The effect of ketoconazole on post-burn inflammation, hypermetabolism and clinical outcomes.

    Directory of Open Access Journals (Sweden)

    Marc G Jeschke

    Full Text Available BACKGROUND: Hypercortisolemia has been suggested as a primary hormonal mediator of whole-body catabolism following severe burn injury. Ketoconazole, an anti-fungal agent, inhibits cortisol synthesis. We, therefore, studied the effect of ketoconazole on post-burn cortisol levels and the hyper-catabolic response in a prospective randomized trial (block randomization 2:1. METHODOLOGY/PRINCIPAL FINDINGS: Fifty-five severely burned pediatric patients with >30% total body surface area (TBSA burns were enrolled in this trial. Patients were randomized to receive standard care plus either placebo (controls, n = 38 or ketoconazole (n = 23. Demographics, clinical data, serum hormone levels, serum cytokine expression profiles, organ function, hypermetabolism measures, muscle protein synthesis, incidence of wound infection sepsis, and body composition were obtained throughout the acute hospital course. Statistical analysis was performed using Fisher's exact test, Student's t-test, and parametric and non-parametric two-way repeated measures analysis of variance where applicable. Patients were similar in demographics, age, and TBSA burned. Ketoconazole effectively blocked cortisol production, as indicated by normalization of the 8-fold elevation in urine cortisol levels [F(1, 376 = 85.34, p<.001] with the initiation of treatment. However, there were no significant differences in the inflammatory response, acute-phase proteins, body composition, muscle protein breakdown or synthesis, or organ function between groups. CONCLUSIONS: Both groups were markedly hypermetabolic and catabolic throughout the acute hospital stay. Normalization of hypercortisolemia with ketoconazole therapy had no effect on whole-body catabolism or the post-burn inflammatory or hypermetabolic response, suggesting that hypercortisolemia does not play a central role in the post-burn hypermetabolic catabolic response. TRIAL REGISTRATION: ClinicalTrials.gov NCT00675714; and NCT

  16. Clinical study on the factors affecting the post-partum recovery of patients with hypertensive pregnancy disorders at a Chinese hospital.

    Science.gov (United States)

    Wei, Jun; Wang, Yan; Xu, Jiayuan; Zhang, Chunfang; Zhou, Helen; Liu, Guoli

    2017-03-01

    The aim of this study was to investigate the post-partum recovery of blood pressure (BP) in women with hypertensive disorders of pregnancy (HDP) and to evaluate HDP risk factors. A total of 124 patients with gestational hypertension (n = 63) or pre-eclampsia (n = 61) who gave birth at Peking University People's Hospital between January and December 2013 were included in this study. The recorded clinical and laboratory parameters included the patients' general information, maternal pre-pregnancy body mass index, gestational weight gain, gestational age at onset and delivery, delivery mode and time taken for BP to return to normal level. Logistic regression analysis was performed to evaluate the influence of various risk factors on post-partum BP recovery. The mean interval for BP normalization was 24.1 ± 22.8 days (median, 7 days). Forty-six percent of the patients recovered from hypertension within three days, and 75% recovered within six weeks of delivery. About 90% of the patients required 60 days for BP to normalize after delivery. After adjusting for confounding factors, post-partum recovery from hypertension was found to be influenced by hypertension severity, maternal serum albumin level, a family history of hypertension and gestational week at delivery. The BP of the majority of the patients with gestational hypertension or pre-eclampsia returned to normal within 60 days of delivery. Hypertension severity, maternal serum albumin level, a family history of family hypertension and gestational week at delivery influenced the time required for BP normalization. © 2016 Japan Society of Obstetrics and Gynecology.

  17. 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.

  18. A theoretical study of solvent effects on the characteristics of the ...

    Indian Academy of Sciences (India)

    adrenaline).25 Unlike norepinephrine and epinephrine themselves, L-DOPS is capable of crossing the protective blood–brain barrier (BBB).25. Data from clinical studies and post-marketing surveil- lance programs conducted in Japan show that the.

  19. Does innovation in obesity drugs affect stock markets? An event study analysis.

    Science.gov (United States)

    Pérez-Rodríguez, Jorge V; González López-Valcárcel, Beatriz

    2012-01-01

    This study empirically analyzes the effects of public information about the pharmaceutical R&D process on the market valuation of the sponsoring firm. We examined the market's response to scientific news and regulatory decisions about an antiobesity drug, rimonabant, and the effects on the sponsoring company (Sanofi-Aventis) and its incumbent competitors (Abbott and Roche). Event study methodology was used to test the null hypothesis of no market response. We covered the full life cycle of rimonabant (1994-2008), using a data set of daily closing price and volume. The results suggest that scientific news in the initial stages of the drug R&D process (i.e., drug discovery, preclinical and clinical trials) had no significant effects. However, news related to regulatory decisions, such as recall or safety warning, had significant negative effects on the company's market value. No spillover/contagion effects on competitor firms were detected. Market reactions occur at the time when the regulator takes decisions about drugs. Scientific news, even those of high-impact, may pass unnoticed. Copyright © 2011 SESPAS. Published by Elsevier España, S.L. All rights reserved.

  20. Online marketing strategies of plastic surgeons and clinics: a comparative study of the United Kingdom and the United States.

    Science.gov (United States)

    Nassab, Reza; Navsaria, Harshad; Myers, Simon; Frame, James

    2011-07-01

    The cosmetic surgery market is a rapidly growing sector of healthcare, and the use of marketing strategies is now an integral part of any cosmetic surgery practice. In this study, the authors review 50 Web sites from practitioners in London and New York to quantify the utilization of online marketing, comparing results between the United Kingdom and the United States.

  1. Predictors of post-traumatic stress disorder following critical illness: A mixed methods study.

    Science.gov (United States)

    Battle, Ceri E; James, Karen; Bromfield, Tom; Temblett, Paul

    2017-11-01

    Post-traumatic stress disorder has been reported in survivors of critical illness. The aim of this study was to investigate the predictors of post-traumatic stress disorder in survivors of critical illness. Patients attending the intensive care unit (ICU) follow-up clinic completed the UK-Post-Traumatic Stress Syndrome 14-Questions Inventory and data was collected from their medical records. Predictors investigated included age, gender, Apache II score, ICU length of stay, pre-illness psychopathology; delirium and benzodiazepine administration during ICU stay and delusional memories of the ICU stay following discharge. A total of 198 patients participated, with 54 (27%) patients suffering with post-traumatic stress disorder. On multivariable logistic regression, the significant predictors of post-traumatic stress disorder were younger age, lower Apache II score, pre-illness psychopathology and delirium during the ICU stay. The predictors of post-traumatic stress disorder in this study concur with previous research however a lower Apache II score has not been previously reported.

  2. Contemporary Welfare Regimes in Baltic States: Adapting Post-Communist Conditions to Post-Modern Challenges

    Directory of Open Access Journals (Sweden)

    Anu Toots

    2010-11-01

    Full Text Available This article revises the conventional approach to welfare state development in the post-communist world, according to which the main challenge for the Eastern European states is to catch up with Western European welfare regimes. The article argues that adjustment to the new social risks and volatile markets is more important today than the catching-up scenario. Based on social and labour market statistics for Estonia, Latvia and Lithuania, the article analyses how the Baltic States are coping with this adjustment challenge. Adaptation to the post-modern conditions can be regarded as successful if the stability of welfare spending is accompanied by the expanding and flexible employment and by the stable or decreasing level of poverty. The findings suggest that the opportunities to increase the flexibility and equality of the labour market provided by the breakdown of the communist regime were not used. Instead, the Baltic welfare states continue to focus on protecting against the old social risks by combining neoliberal and post-communist principles. Poor performance in meeting new social risks poses a greater challenge for the post-communist welfare states than their lag in terms of gross welfare expenditure.

  3. 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...

  4. [Discussion on development of four diagnostic information scale for clinical re-evaluation of postmarketing herbs].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-12-01

    Post-marketing re-evaluation of Chinese herbs can well reflect Chinese medicine characteristics, which is the most easily overlooked the clinical re-evaluation content. Since little attention has been paid to this, study on the clinical trial design method was lost. It is difficult to improving the effectiveness and safety of traditional Chinese medicine. Therefore, more attention should be paid on re-evaluation of the clinical trial design method point about tcm syndrome such as the type of research program design, the study of Chinese medical information collection scale and statistical analysis methods, so as to improve the clinical trial design method study about tcm syndrome of Chinese herbs postmarketing re-evalutation status.

  5. The adoption of provider-based rural health clinics by rural hospitals: a study of market and institutional forces.

    Science.gov (United States)

    Krein, S L

    1999-04-01

    To examine the response of rural hospitals to various market and organizational signals by determining the factors that influence whether or not they establish a provider-based rural health clinic (RHC) (a joint Medicare/Medicaid program). Several secondary sources for 1989-1995: the AHA Annual Survey, the PPS Minimum Data Set and a list of RHCs from HCFA, the Area Resource File, and professional associations. The analysis includes all general medical/surgical rural hospitals operating in the United States during the study period. A longitudinal design and pooled cross-sectional data were used, with the rural hospital as the unit of analysis. Key variables were examined as sets and include measures of competitive pressures (e.g., hospital market share), physician resources, nurse practitioner/physician assistant (NP/PA) practice regulation, hospital performance pressures (e.g., operating margin), innovativeness, and institutional pressure (i.e., the cumulative force of adoption). Adoption of provider-based RHCs by rural hospitals appears to be motivated less as an adaptive response to observable economic or internal organizational signals than as a reaction to bandwagon pressures. Rural hospitals with limited resources may resort to imitating others because of uncertainty or a limited ability to fully evaluate strategic activities. This can result in actions or behaviors that are not consistent with policy objectives and the perceived need for policy changes. Such activity in turn could have a negative effect on some providers and some rural residents.

  6. Clinical utility of high b-value diffusion-weighted magnetic resonance imaging in post-resuscitative encephalopathy

    International Nuclear Information System (INIS)

    Kano, Hitoshi; Danjou, Wataru; Yamazaki, Kei

    2002-01-01

    It is very important to estimate brain functional capacity immediately after successful cardiopulmonary resuscitation (CPR) to determine subsequent treatment strategy and to elucidate the pathophysiology of patients with post-resuscitative encephalopathy. However, computed tomography scanning, electric encephalography and conventional magnetic resonance imaging do not contribute significantly to the assessment of brain functions immediately after CPR. Recently, diffusion-weighted magnetic resonance imaging (DW-MRI) has been applied to the patients with post-resuscitative encephalopathy. However, no papers have described serial clinical and repeated DW-MRI studies of patients during the acute phase of post-resuscitative encephalopathy. Moreover, in some cases, high signal intensity in the cortex after CPR is indistinguishable from normal cortex. Thus, we tried to apply high b-value DW-MRI to estimate the brain function of patients with post-resuscitative encephalopathy. This study was performed on 11 patients with post-resuscitative encephalopathy and 5 healthy volunteers as controls. DW-MRI was performed using GYROSCAN 1.5 Tesla MR imager (Philips) with single-shot echo-planner imaging sequences performed 3 times, first within 24 hours after CPR, second between day 3 to 6, and third more than 7 days after CPR. And we tested the usefulness of DW-MRI at 800, 1000, 1500, 2000 and 3000 in b value. Five patients survived, one fully recovered and four remained in a vegetative state. The other six died with clinical brain death. The first DW-MRI revealed in high signal intensity in the frontal and the parietal lobes in all patients who eventually progressed to a vegetative state or brain death. This result was much more wide-spread in the latter patients, while it was never seen in the patients who recovered fully. The high signal intensity areas increased in follow-up DW-MRI studies. The signal intensity remained high in some parts, while it decreased in other parts with

  7. Clinical utility of high b-value diffusion-weighted magnetic resonance imaging in post-resuscitative encephalopathy

    Energy Technology Data Exchange (ETDEWEB)

    Kano, Hitoshi; Danjou, Wataru; Yamazaki, Kei [Sapporo City General Hospital (Japan)] (and others)

    2002-03-01

    It is very important to estimate brain functional capacity immediately after successful cardiopulmonary resuscitation (CPR) to determine subsequent treatment strategy and to elucidate the pathophysiology of patients with post-resuscitative encephalopathy. However, computed tomography scanning, electric encephalography and conventional magnetic resonance imaging do not contribute significantly to the assessment of brain functions immediately after CPR. Recently, diffusion-weighted magnetic resonance imaging (DW-MRI) has been applied to the patients with post-resuscitative encephalopathy. However, no papers have described serial clinical and repeated DW-MRI studies of patients during the acute phase of post-resuscitative encephalopathy. Moreover, in some cases, high signal intensity in the cortex after CPR is indistinguishable from normal cortex. Thus, we tried to apply high b-value DW-MRI to estimate the brain function of patients with post-resuscitative encephalopathy. This study was performed on 11 patients with post-resuscitative encephalopathy and 5 healthy volunteers as controls. DW-MRI was performed using GYROSCAN 1.5 Tesla MR imager (Philips) with single-shot echo-planner imaging sequences performed 3 times, first within 24 hours after CPR, second between day 3 to 6, and third more than 7 days after CPR. And we tested the usefulness of DW-MRI at 800, 1000, 1500, 2000 and 3000 in b value. Five patients survived, one fully recovered and four remained in a vegetative state. The other six died with clinical brain death. The first DW-MRI revealed in high signal intensity in the frontal and the parietal lobes in all patients who eventually progressed to a vegetative state or brain death. This result was much more wide-spread in the latter patients, while it was never seen in the patients who recovered fully. The high signal intensity areas increased in follow-up DW-MRI studies. The signal intensity remained high in some parts, while it decreased in other parts with

  8. Does electronic clinical microbiology results reporting influence medical decision making: a pre- and post-interview study of medical specialists.

    Science.gov (United States)

    Bruins, Marjan J; Ruijs, Gijs J H M; Wolfhagen, Maurice J H M; Bloembergen, Peter; Aarts, Jos E C M

    2011-03-30

    Clinicians view the accuracy of test results and the turnaround time as the two most important service aspects of the clinical microbiology laboratory. Because of the time needed for the culturing of infectious agents, final hardcopy culture results will often be available too late to have a significant impact on early antimicrobial therapy decisions, vital in infectious disease management. The clinical microbiologist therefore reports to the clinician clinically relevant preliminary results at any moment during the diagnostic process, mostly by telephone. Telephone reporting is error prone, however. Electronic reporting of culture results instead of reporting on paper may shorten the turnaround time and may ensure correct communication of results. The purpose of this study was to assess the impact of the implementation of electronic reporting of final microbiology results on medical decision making. In a pre- and post-interview study using a semi-structured design we asked medical specialists in our hospital about their use and appreciation of clinical microbiology results reporting before and after the implementation of an electronic reporting system. Electronic reporting was highly appreciated by all interviewed clinicians. Major advantages were reduction of hardcopy handling and the possibility to review results in relation to other patient data. Use and meaning of microbiology reports differ significantly between medical specialties. Most clinicians need preliminary results for therapy decisions quickly. Therefore, after the implementation of electronic reporting, telephone consultation between clinician and microbiologist remained the key means of communication. Overall, electronic reporting increased the workflow efficiency of the medical specialists, but did not have an impact on their decision-making. © 2011 Bruins et al; licensee BioMed Central Ltd.

  9. Does electronic clinical microbiology results reporting influence medical decision making: a pre- and post-interview study of medical specialists

    Directory of Open Access Journals (Sweden)

    Bloembergen Peter

    2011-03-01

    Full Text Available Abstract Background Clinicians view the accuracy of test results and the turnaround time as the two most important service aspects of the clinical microbiology laboratory. Because of the time needed for the culturing of infectious agents, final hardcopy culture results will often be available too late to have a significant impact on early antimicrobial therapy decisions, vital in infectious disease management. The clinical microbiologist therefore reports to the clinician clinically relevant preliminary results at any moment during the diagnostic process, mostly by telephone. Telephone reporting is error prone, however. Electronic reporting of culture results instead of reporting on paper may shorten the turnaround time and may ensure correct communication of results. The purpose of this study was to assess the impact of the implementation of electronic reporting of final microbiology results on medical decision making. Methods In a pre- and post-interview study using a semi-structured design we asked medical specialists in our hospital about their use and appreciation of clinical microbiology results reporting before and after the implementation of an electronic reporting system. Results Electronic reporting was highly appreciated by all interviewed clinicians. Major advantages were reduction of hardcopy handling and the possibility to review results in relation to other patient data. Use and meaning of microbiology reports differ significantly between medical specialties. Most clinicians need preliminary results for therapy decisions quickly. Therefore, after the implementation of electronic reporting, telephone consultation between clinician and microbiologist remained the key means of communication. Conclusions Overall, electronic reporting increased the workflow efficiency of the medical specialists, but did not have an impact on their decision-making.

  10. 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

  11. The adaptation of health care marketing to the digital era.

    Science.gov (United States)

    Radu, G; Solomon, M; Gheorghe, C M; Hostiuc, M; Bulescu, I A; Purcarea, V L

    2017-01-01

    The purpose of health care marketing is to learn and understand the needs and desires of prospective patients in order to be able to meet those necessities at the highest standards. A big advantage is the targeting capability of the electronic media that has led to its being used by managers of marketing in medical institutions as means of advertisement when they develop the marketing strategies. Regarding social media, it is safe to say that there are communication platforms that can promote certain behaviours thus influencing decision-making. Through social media, people stay in touch with other people and they can provide a mean for medical institutions to permanently communicate with the existing patients or with the potential ones. In addition, social media can be used in advertising and promoting strategies, by posting information about discounts, offers and advantages of accessing the products provided by a certain institution. A study was conducted on 126 patients of a dental clinic in Bucharest. 126 new patients were selected on a period of 22 months from January 2015 until October 2016. The patients never had any treatment in this clinic and were influenced by the Internet to seek for dental care services. The purpose of this study was to evaluate the digital methods of promoting medical services, bringing new patients to a clinic. The results of the study demonstrated the need for digital methods of promoting medical care services in order to expand a business. A strategic way of thinking in this case implied attracting new patients and offering them quality health care services, which ensured their satisfaction and the probability of their recommending the health facility further. This study revealed an important role of social networking sites in promoting. This high response was probably responsible due to targeted promoting services. Almost all the new patients who completed the form will remain patients of this clinic in future.

  12. The adaptation of health care marketing to the digital era

    Science.gov (United States)

    Radu, G; Solomon, M; Gheorghe, CM; Hostiuc, M; Bulescu, IA; Purcarea, VL

    2017-01-01

    The purpose of health care marketing is to learn and understand the needs and desires of prospective patients in order to be able to meet those necessities at the highest standards. A big advantage is the targeting capability of the electronic media that has led to its being used by managers of marketing in medical institutions as means of advertisement when they develop the marketing strategies. Regarding social media, it is safe to say that there are communication platforms that can promote certain behaviours thus influencing decision-making. Through social media, people stay in touch with other people and they can provide a mean for medical institutions to permanently communicate with the existing patients or with the potential ones. In addition, social media can be used in advertising and promoting strategies, by posting information about discounts, offers and advantages of accessing the products provided by a certain institution. A study was conducted on 126 patients of a dental clinic in Bucharest. 126 new patients were selected on a period of 22 months from January 2015 until October 2016. The patients never had any treatment in this clinic and were influenced by the Internet to seek for dental care services. The purpose of this study was to evaluate the digital methods of promoting medical services, bringing new patients to a clinic. The results of the study demonstrated the need for digital methods of promoting medical care services in order to expand a business. A strategic way of thinking in this case implied attracting new patients and offering them quality health care services, which ensured their satisfaction and the probability of their recommending the health facility further. This study revealed an important role of social networking sites in promoting. This high response was probably responsible due to targeted promoting services. Almost all the new patients who completed the form will remain patients of this clinic in future. PMID:28255375

  13. 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.

  14. [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.

  15. Comfort level of post graduate residents working in different clinical domains in managing common ophthalmic conditions

    International Nuclear Information System (INIS)

    Jaffar, S.; Tayyab, A.; Shah, S.S.; Naseem, S.; Ghazanfar, H.

    2016-01-01

    Background: Ophthalmological conditions are frequently encountered in almost all clinical specialties. Assessing the adequacy of ophthalmology teaching in undergraduate medical education is important in order to diagnose and manage different ophthalmological conditions. The objective of this study was to determine the comfort level of post graduate residents working in different clinical domains in managing common ophthalmic conditions. Methods: A cross sectional survey involving 277 post graduate residents was carried out over a period of six months in both private and public tertiary care hospital. A questionnaire containing two sections and 17 variables in total were distributed among Medical Residents of different specialties except ophthalmology residents. Participants of the study were selected through consecutive non probability sampling. Results: Mean hours of classroom based ophthalmology instruction during during undergraduate program was 59.38 hours (55.9) and mean hours of clinical based ophthalmology instruction during undergraduate program was 62.73 hours (60.8) 54 percentage were either not comfortable or somewhat comfortable in managing common ophthalmic condition. Conclusion: Teaching hours in under graduate program meet or exceed requisite criteria. However graduating doctors generally feel that the time spent does not provide them with the comfort and skill level required to care for patients with ocular presentations. (author)

  16. Philippines' experience in marketing irradiated foods

    International Nuclear Information System (INIS)

    Lustre, A. O.; Ang, L.; Dianco, A.

    1985-01-01

    The Food Terminal Inc. in Manila, in cooperation with the Philippine Atomic Energy Agency and with funding support from the International Atomic Energy Agency in Vienna has been conducting storage and marketing studies on onions, garlic and mangoes. The objective is to gather loss reduction data and consumer reaction information that can serve as a basis for evaluating the risks and benefits involved in the establishment of a commercial food irradiator in the country. These studies show that irradiation reduces low-temperature storage losses in onions and garlic by 10-40% and post-storage marketing losses at ambient conditions by 16-50% in onions. Post-storage marketing trials not only indicate a significant reduction in losses during shipping and retail sale but a large increase in the marketability of irradiated commodities as measured by the rate of sale of the commodity and the price which it commands during the selling period. No adverse consumer reaction occurred during the sale of irradiated foods labelled as such except for a few comments indicating fear, ignorance and/or curiosity. The importance of irradiation as a substitute quarantine treatment for mangoes and for eliminating Salmonella in frozen foods for export is discussed in relation to the growing importance of these commodities to the Philippines' non-traditional export markets. Other applications of irradiation that could result in a perceptible improvement in the marketability of food commodities in the Philippines are discussed. Marketing studies are invaluable in evaluating the potential benefits of a new technology as food irradiation. In view of this, there is great interest in the completion of a pilot plant for food irradiation by the Philippine Atomic Energy Commission. The design and capacity of this plant are discussed

  17. 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...

  18. A Prospective Study on the Clinical and Microbiological Spectrum of Endophthalmitis in a Specific Region in Denmark

    DEFF Research Database (Denmark)

    Solborg Bjerrum, Søren; Hamoudi, Hassan; Friis-Møller, Alice

    2016-01-01

    PURPOSE: To study the clinical and microbiological spectrum of endophthalmitis with emphasis on clinical features, visual outcomes and risks of surgical complications. METHODS: A prospective observational study was conducted between 2012 and 2013 in a specific region in Denmark. Patients were...... clinically examined before, during and after surgical intervention for endophthalmitis. RESULTS: Fifty eyes with endophthalmitis were included. Endophthalmitis after cataract surgery (post-cataract), anti-VEGF (vascular endothelial growth factor) intravitreal injections (post-injection) and cases...... of endogenous endophthalmitis were responsible for 40, 28 and 18% of all cases, respectively. There was no difference in the microbiological spectrum in post-cataract patients and post-injection patients, but patients with post-cataract endophthalmitis presented statistically significantly more frequently...

  19. 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.

  20. 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.

  1. A study on the effects of marketing communication using integrated marketing communication

    Directory of Open Access Journals (Sweden)

    Solmaz Sellahvarzi

    2014-07-01

    Full Text Available Integrated Marketing Communication (IMC is one of the needed concepts in competitive edge. IMC is defined as a cross functional process for creating and nourishing profitable relationships with customers and other stakeholders by strategically controlling or impacting all messages sent to these groups. It ensures that all forms of communications and messages are carefully linked together. This study investigates the effectiveness of marketing communication in an Iranian automaker named Khodro using IMC system. The study tries to audit the rate of marketing relationship integrity and its outcome on organization performance. The study designs a questionnaire and distributes it among 384 randomly selected people who use this firm’s services and Cronbach alpha has been calculated as 0.974. Hypotheses of this survey are exanimated by Pearson correlation test as well as pairwise t-student tests. The results show the effects of integrated marketing Communication on organization performance. In addition, there is a significant positive correlation relationship between integrated marketing communication with mission marketing, Cross functional Strategic Planning and Interactivity. Finally, there is a significant positive correlation relationship between dimensions of IMC.

  2. Attention and Recall of Point-of-sale Tobacco Marketing: A Mobile Eye-Tracking Pilot Study

    Directory of Open Access Journals (Sweden)

    Maansi Bansal-Travers

    2016-01-01

    Full Text Available  Introduction: As tobacco advertising restrictions have increased, the retail ‘power wall’ behind the counter is increasingly invaluable for marketing tobacco products. Objective: The primary objectives of this pilot study were 3-fold: (1 evaluate the attention paid/fixations on the area behind the cash register where tobacco advertising is concentrated and tobacco products are displayed in a real-world setting, (2 evaluate the duration (dwell-time of these fixations, and (3 evaluate the recall of advertising displayed on the tobacco power wall. Methods: Data from 13 Smokers (S and 12 Susceptible or non-daily Smokers (SS aged 180–30 from a mobile eye-tracking study. Mobile-eye tracking technology records the orientation (fixation and duration (dwell-time of visual attention. Participants were randomized to one of three purchase tasks at a convenience store: Candy bar Only (CO; N = 10, Candy bar + Specified cigarette Brand (CSB; N = 6, and Candy bar + cigarette Brand of their Choice (CBC; N = 9. A post-session survey evaluated recall of tobacco marketing. Key outcomes were fixations and dwell-time on the cigarette displays at the point-of-sale. Results: Participants spent a median time of 44 seconds during the standardized time evaluated and nearly three-quarters (72% fixated on the power wall during their purchase, regardless of smoking status (S: 77%, SS: 67% or purchase task (CO: 44%, CSB: 71%, CBC: 100%. In the post session survey, nearly all participants (96% indicated they noticed a cigarette brand and 64% were able to describe a specific part of the tobacco wall or recall a promotional offer. Conclusions: Consumers are exposed to point-of-sale tobacco marketing, regardless of smoking status. FDA should consider regulations that limit exposure to point-of-sale tobacco marketing among consumers.

  3. Attention and Recall of Point-of-sale Tobacco Marketing: A Mobile Eye-Tracking Pilot Study.

    Science.gov (United States)

    Bansal-Travers, Maansi; Adkison, Sarah E; O'Connor, Richard J; Thrasher, James F

    2016-01-01

    As tobacco advertising restrictions have increased, the retail 'power wall' behind the counter is increasingly invaluable for marketing tobacco products. The primary objectives of this pilot study were 3-fold: (1) evaluate the attention paid/fixations on the area behind the cash register where tobacco advertising is concentrated and tobacco products are displayed in a real-world setting, (2) evaluate the duration (dwell-time) of these fixations, and (3) evaluate the recall of advertising displayed on the tobacco power wall. Data from 13 Smokers (S) and 12 Susceptible or non-daily Smokers (SS) aged 180-30 from a mobile eye-tracking study. Mobile-eye tracking technology records the orientation (fixation) and duration (dwell-time) of visual attention. Participants were randomized to one of three purchase tasks at a convenience store: Candy bar Only (CO; N = 10), Candy bar + Specified cigarette Brand (CSB; N = 6), and Candy bar + cigarette Brand of their Choice (CBC; N = 9). A post-session survey evaluated recall of tobacco marketing. Key outcomes were fixations and dwell-time on the cigarette displays at the point-of-sale. Participants spent a median time of 44 seconds during the standardized time evaluated and nearly three-quarters (72%) fixated on the power wall during their purchase, regardless of smoking status (S: 77%, SS: 67%) or purchase task (CO: 44%, CSB: 71%, CBC: 100%). In the post session survey, nearly all participants (96%) indicated they noticed a cigarette brand and 64% were able to describe a specific part of the tobacco wall or recall a promotional offer. Consumers are exposed to point-of-sale tobacco marketing, regardless of smoking status. FDA should consider regulations that limit exposure to point-of-sale tobacco marketing among consumers.

  4. 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.

  5. Point-of-care diagnostics: market trends and growth drivers.

    Science.gov (United States)

    Rajan, Aruna; Glorikian, Harry

    2009-01-01

    There is a significant demand for in vitro diagnostic (IVD) testing to move closer to the patient point-of-care diagnostics [POC]), whether in the hospital, physician's office, rapid clinic or the home, effectively cutting time to results and helping patients make better informed decisions about their health. To analyze the point-of-care market and its trends and growth drivers. In 2007, POC made up 30% of the IVD market and is expected to grow at 9% a year. Although the overall POC market is expected to grow steadily, infectious POC is now the most attractive segment. Availability of rapid random access molecular diagnostic system for critical care infectious diseases such as MRSA and sepsis in the near future is likely to be a significant driver of infectious POC post 2012. Owing to the extraordinary increase in the cost of care, healthcare delivery is moving to increasingly decentralized settings such as rapid clinics and the home, driven by point-of-care diagnostics that provide accurate and directional results. We are evolving from the analog testing world to the digital testing world, where diagnosis is exact and therapy can be administered and be predictably effective.

  6. randomised double blind study to compare effectiveness of honey

    African Journals Online (AJOL)

    2014-02-02

    Feb 2, 2014 ... EAsT AFRICAN MEDICAL JOURNAL. February 2014 .... based randomised double- blinded clinical trial evaluating effectiveness of ... study drugs was undertaken following a random ... included sodium citrate, citric acid monohydrate, ... post-hoc test to carry out pair-wise comparisons of .... self-care market.

  7. Migration between the United States and Canada: a study of labour market adjustment.

    Science.gov (United States)

    Brox, J A

    1983-01-01

    "... The main purpose of this study is to examine population flows between Canada and the United States [from mid-1947 to mid-1972] in order to investigate the degree to which labour market adjustment is aided by such movements. [The author considers] several functional forms of the migration relationship in an attempt to empirically determine how the decision to migrate is formed. [He also compares the] results with those obtained by Courchene...for Canadian interprovincial migration in an effort to compare the effects of international and internal migration on labour market adjustment." It is found that "migration between the United States and Canada over the post-war period is an economic variable. In fact, [a] simple model employing differences in income levels and unemployment rates has been able to explain nearly ninety-five per cent of the variation in the migration rate." The author also notes that "although migration between Canada and the United States does occur in such a way as to aid labour market adjustment, it is not as efficient as internal migration." (summary in FRE, SPA) excerpt

  8. Clinical and pathologic factors predictive of biochemical control following post-prostatectomy irradiation

    International Nuclear Information System (INIS)

    Stromberg, Jannifer S.; Ziaja, Ellen L.; Horwitz, Eric M.; Vicini, Frank A.; Brabbins, Donald S.; Dmuchowski, Carl F.; Gonzalez, Jose; Martinez, Alvaro A.

    1996-01-01

    Purpose/Objective: Indications for post-prostatectomy radiation therapy are not well defined. We reviewed our experience treating post-prostatectomy patients with external beam irradiation to assess clinical and pathologic factors predictive of biochemical control. Materials and Methods: Between 1/87 and 3/93, 61 patients received post-operative tumor bed irradiation with a median dose of 59.4 Gy (50.4 - 68 Gy). Median follow-up was 4.1 years (7.6 months - 8.3 years) from irradiation. Patients were treated for the following reasons: 1) adjuvantly, within 6 months of surgery for extracapsular extension, seminal vesicle involvement, or positive surgical margins (n=38); 2) persistently elevated PSA post-operatively (n=2); 3) rising PSA >6 months after surgery (n=9); and 4) biopsy proven local recurrence (n=12). No patients had known nodal or metastatic disease. All patients had post-radiation PSA data available. Biochemical control was the endpoint studied using Kaplan-Meier life table analysis. Biochemical control was defined as the ability to maintain an undetectable PSA ( 4 and ≤1 0, >10 and ≤20, and > 20 ng/ml. The 3 year actuarial rates of biochemical control were 100% for group 1, 66.7% for group 2, 61.5% for group 3, and 28.6% for group 4. Pre-RT PSA values were also evaluated. Univariate Cox models indicated lower presurgical and pre-RT PSA values were predictive of biochemical control (p=0.017, p 6 months after surgery (group 3), the 3 year actuarial rate of biochemical control was 55.6%. The 3 year actuarial rate of biochemical control for patients treated for a biopsy proven recurrence (group 4) was 8.3%. By pair-wise log rank test, the rates of biochemical control were significantly different between groups 1 and 3 (p=0.036), groups 1 and 4 (p<0.001), and groups 3 and 4 (p=0.009). Conclusion: Biochemical control was achieved in approximately half of the patients treated with post-operative prostatic fossa irradiation. Elevated presurgical and pre

  9. Developing Medicare Competitive Bidding: A Study of Clinical Laboratories

    Science.gov (United States)

    Hoerger, Thomas J.; Meadow, Ann

    1997-01-01

    Competitive bidding to derive Medicare fees promises several advantages over administered fee systems. The authors show how incentives for cost savings, quality, and access can be incorporated into bidding schemes, and they report on a study of the clinical laboratory industry conducted in preparation for a bidding demonstration. The laboratory industry is marked by variable concentration across geographic markets and, among firms themselves, by social and economic heterogeneity. The authors conclude that these conditions can be accommodated by available bidding design options and by careful selection of bidding markets. PMID:10180003

  10. 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.

  11. Mental health problems and post-migration stress among multi-traumatized refugees attending outpatient clinics upon resettlement to Norway.

    Science.gov (United States)

    Teodorescu, Dinu-Stefan; Heir, Trond; Hauff, Edvard; Wentzel-Larsen, Tore; Lien, Lars

    2012-08-01

    Refugees have often been exposed to multiple traumas making them prone to mental health problems later. The aim of this study is to describe the prevalence and symptom load of psychiatric disorders in refugees admitted to psychiatric outpatient clinics and to investigate the relationship between multiple exposure to traumatic events, the severity of traumatic symptoms and post-migration stressors. A clinical sample of 61 refugee outpatients from psychiatric clinics in Southern Norway was cross-sectionally examined using three structured clinical interviews (SCID-PTSD, SIDES and MINI) and self-report psychometric instruments (HSCL-25, IES-R). Post-traumatic Stress Disorder (PTSD) was diagnosed in 82% of the patients, while Disorders of Extreme Stress Not Otherwise Specified (DESNOS) was present in 16% of them. Comorbidity was considerable; 64% of the patients had both PTSD and major depression disorder (MDD) and 80% of those who had PTSD had three or more additional diagnoses. Multi-traumatized refugees in outpatient clinics have high prevalence of PTSD, DESNOS, comorbid depression and anxiety disorders. A more severe symptomatology was found in patients diagnosed with both PTSD and DESNOS, than in those diagnosed with only PTSD. Higher rates of unemployment, weak social network and weak social integration were also prevalent in these outpatients, and related to increased psychiatric comorbidity and severity of symptoms. Further research may clarify the existence of a cumulative relationship between pre-resettlement traumas and post-resettlement stressors in the mental health of refugees, which in turn may help to improve therapeutic interventions. © 2012 The Authors. Scandinavian Journal of Psychology © 2012 The Scandinavian Psychological Associations.

  12. Extra-institutional changes under pressure from posting

    DEFF Research Database (Denmark)

    Arnholtz, Jens; Andersen, Søren Kaj

    2018-01-01

    The posting of workers has become a key topic in debates about how national labour relations respond to pressures from EU market making. While most prior studies have shown that national employment relations are under pressure from above (via EU regulation) and from below (due to increasing use...... of posting), the question is whether these pressures will lead to erosion of employment relations or adaptation at the national level. Taking the case of posting in the Danish construction sector, the article shows that, while formal institutions stay the same through minor adaptation, the increasing use...

  13. Impact of implementing electronic clinical practice guidelines for the diagnosis, control and treatment of cardiovascular risk factors: A pre-post controlled study.

    Science.gov (United States)

    Comin, Eva; Catalan-Ramos, Arantxa; Iglesias-Rodal, Manuel; Grau, Maria; Del Val, Jose Luis; Consola, Alicia; Amado, Ester; Pons, Angels; Mata-Cases, Manel; Franzi, Alicia; Ciurana, Ramon; Frigola, Eva; Cos, Xavier; Davins, Josep; Verdu-Rotellar, Jose M

    To evaluate the impact of computerized clinical practice guidelines on the management, diagnosis, treatment, control, and follow-up of the main cardiovascular risk factors: hypertension, hypercholesterolaemia, and type 2 diabetes mellitus. Pre-post controlled study. Catalonia, autonomous community located in north-eastern Spain. Individuals aged 35-74 years assigned to general practitioners of the Catalan Health Institute. The intervention group consisted of individuals whose general practitioners had accessed the computerized clinical practice guidelines at least twice a day, while the control group consisted of individuals whose general practitioner had never accessed the computerized clinical practice guidelines platform. The Chi-squared test was used to detect significant differences in the follow-up, control, and treatment variables for all three disorders (hypertension, hypercholesterolaemia, and type 2 diabetes mellitus) between individuals assigned to users and non-users of the computerized clinical practice guidelines, respectively. A total of 189,067 patients were included in this study, with a mean age of 56 years (standard deviation 12), and 55.5% of whom were women. Significant differences were observed in hypertension management, treatment and control; type 2 diabetes mellitus management, treatment and diagnoses, and the management and control of hypercholesterolaemia in both sexes. Computerized clinical practice guidelines are an effective tool for the control and follow-up of patients diagnosed with hypertension, type 2 diabetes mellitus, and hypercholesterolaemia. The usefulness of computerized clinical practice guidelines to diagnose and adequately treat individuals with these disorders remains unclear. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  14. 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

  15. Community Pharmacy Marketing: Strategies for Success

    Directory of Open Access Journals (Sweden)

    Kristina D. Wood

    2011-01-01

    Full Text Available Purpose: As community pharmacies are implementing increasingly more clinical services they are faced with a new challenge of marketing these services. This article discusses The Ohio State University College of Pharmacy Clinical Partners Program's (Clinical Partners experiences in marketing clinical services to patients, barriers encountered through these experiences, and presents suggestions for future marketing of services. Experience: Clinical Partners developed two targeted marketing projects and evaluated impact on patient enrollment in services. In January 2008, the pharmacy ran a series of radio advertisements, newspaper print advertisements, and face to face marketing in the community with the focus of each being patient care services. During this project five individuals expressed interest in Clinical Partners' services. Four indicated that they heard about Clinical Partners through the radio ad and one through the pharmacy website, though none chose to enroll in services. In 2009 Clinical Partners focused on marketing MTM in the form of a comprehensive medication review to current patients already enrolled in its anticoagulation management service. Following a three month period, 6 patients (8% of the 71 patients receiving the marketing intervention chose to enroll in MTM. Four additional patients have enrolled in MTM since conclusion of the project. Discussion: These projects and a review of available literature revealed barriers that pharmacies encounter when marketing clinical services to patients in an outpatient setting including patients' unawareness of the role a pharmacist can play outside dispensing medications, patients' belief they do not need clinical services, and patients' unwillingness to pay a pharmacist out of pocket for services. Future Implications: To overcome these identified challenges, community pharmacies should consider integration of marketing techniques such as tailoring marketing to a target population

  16. Community Pharmacy Marketing: Strategies for Success

    Directory of Open Access Journals (Sweden)

    Jennifer L. Rodis, Pharm.D., B.C.P.S.

    2011-01-01

    Full Text Available Purpose: As community pharmacies are implementing increasingly more clinical services they are faced with a new challenge of marketing these services. This article discusses The Ohio State University College of Pharmacy Clinical Partners Program’s (Clinical Partners experiences in marketing clinical services to patients, barriers encountered through these experiences, and presents suggestions for future marketing of services.Experience: Clinical Partners developed two targeted marketing projects and evaluated impact on patient enrollment in services. In January 2008, the pharmacy ran a series of radio advertisements, newspaper print advertisements, and face to face marketing in the community with the focus of each being patient care services. During this project five individuals expressed interest in Clinical Partners’ services. Four indicated that they heard about Clinical Partners through the radio ad and one through the pharmacy website, though none chose to enroll in services. In 2009 Clinical Partners focused on marketing MTM in the form of a comprehensive medication review to current patients already enrolled in its anticoagulation management service. Following a three month period, 6 patients (8% of the 71 patients receiving the marketing intervention chose to enroll in MTM. Four additional patients have enrolled in MTM since conclusion of the project.Discussion: These projects and a review of available literature revealed barriers that pharmacies encounter when marketing clinical services to patients in an outpatient setting including patients’ unawareness of the role a pharmacist can play outside dispensing medications, patients’ belief they do not need clinical services, and patients’ unwillingness to pay a pharmacist out of pocket for services.Future Implications: To overcome these identified challenges, community pharmacies should consider integration of marketing techniques such as tailoring marketing to a target

  17. School of Management, Marketing and Commerce Studies

    Directory of Open Access Journals (Sweden)

    R. B. Nozdryova

    2014-01-01

    Full Text Available Governance and regulation at the national and international level, the management system of the leading companies in the world, forms and methods of management, and marketing, commercial and advertising work form a relatively new subject field in domestic science. These issues have been introduced into the educational process in Russian universities in the second half of the 1980s. At the MGIMO these research areas have been developed for more than 60 years. Scientific School of the Department of Management and Marketing and the Department of Management Foreign Economic Activity is oriented at the international level and focuses on the development of organizational forms and methods of management, marketing strategy, marketing, and commerce in the context of foreign trade and international activities of domestic firms and organizations on the basis of a comprehensive study of advanced management experience of leading foreign countries. In the early stages of its existence, the school was focused on methodological and practical aspects of international commerce and advertising. But gradually its research encompassed the field of management and marketing, and the scientific school in the field of international management and marketing was established on the basis of examination of relevant theories and experiences of leading foreign countries, and especially multinational companies. Originally these studies were conducted by the Department International Economic Relations of the Faculty of International Economic Relations at MGIMO. The disciplines included studies of the foreign trade operations in global markets, management of foreign economic activities in foreign countries, world commodity markets, and others. The textbook "Organization and technology of foreign trade in the capitalist market" by I.N. Gerchikova, Honored Scientist of the Russian Federation, Doctor of Economic Science, Professor, published in 1977 already contained sections on

  18. 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

  19. Post-Keynesianism: Evolution of Keynesian Macroeconomics in the 20 Century

    Directory of Open Access Journals (Sweden)

    Lyubov N. Artamonova

    2016-01-01

    Full Text Available The article analyzes the development of J.M. Keynes's theory in the second half of the twentieth century due to the works within the new direction of economical science - Post-Keynesianism. It is shown that in free-market economy Keynesian school based of the original Keynesian methodology requires additional studies of state regulation principles and take into account the qualitative changes in the market mechanisms. It is shown that post-Keynesianism has had a significant impact on the subject of research and has taken into account the principles of free enterprise, market pricing, level of price dynamics. All this principles allow realizing the principle of self-regulation of the market mechanism. New approaches to the post-Keynesians role of the state and state regulation combined with the freedom of entrepreneurship are analyzed. Taking into account real changes and economic crises it is necessary to analyze the main directions of development of the Keynesian model of economic regulation with a view to their effective use in shaping economic policy. There are considered the basic directions of development of post-Keynesianism such as Neo-Ricardian theory of value and prices of goods based on direct costs of production in the framework of macroeconomic model by P. Sraffa, information theory of "fundamental" uncertainty of the future by R. Klauder and the theory of financial instability hypothesis by H. Minsky. Their differences within the framework of post-Keynesianism under the subject specialization are considered. It is noted that the development of PostKeynesianism allows to present the latest research in modern Keynesian school within an interdisciplinary approach to economical problems.

  20. Ibuprofen versus acetaminophen as a post-partum analgesic for women with severe pre-eclampsia: randomized clinical study.

    Science.gov (United States)

    Vigil-De Gracia, Paulino; Solis, Valentin; Ortega, Nelson

    2017-06-01

    To compare differences in blood pressure levels between patients with severe post-partum pre-eclampsia using ibuprofen or acetaminophen. A randomized controlled trial was made in women with severe pre-eclampsia or superimposed pre-eclampsia after vaginal birth. The patient was randomly selected to receive either 400 mg of ibuprofen every 8 h or 1 g of acetaminophen every 6 h during the post-partum. The primary variable was systolic hypertension ≥150 mmHg and/or diastolic hypertension ≥100 mmHg after the first 24 h post-partum. Secondary variables were the arterial blood pressure readings at 24, 48, 72, and 96 h post-partum and maternal complications. A total of 113 patients were studied: 56 in the acetaminophen group and 57 in the ibuprofen group. With regard to the primary outcome, more cases were significantly hypertensive in the ibuprofen group (36/57; 63.1%) than in the acetaminophen group (16/56; 28.6%). Severe hypertension (≥160/110 mmHg) was not significantly different between the groups, 14.5% (acetaminophen) and 24.5% (ibuprofen). The levels of arterial blood pressure show a hammock-shaped curve independent of the drug used, however, is more noticeable with ibuprofen. This study shows that ibuprofen significantly elevates blood pressure in women with severe pre-eclampsia during the post-partum period.

  1. [Chronic bacterial prostatitis. Clinical and microbiological study of 332 cases].

    Science.gov (United States)

    Heras-Cañas, Víctor; Gutiérrez-Soto, Blanca; Serrano-García, María Luisa; Vázquez-Alonso, Fernando; Navarro-Marí, José María; Gutiérrez-Fernández, José

    2016-08-19

    Chronic bacterial prostatitis (CBP) is characterized by long-lasting symptoms, frequently associated with psychosomatic disorders. The objective of the study was to study PCB in our environment clinically and microbiologically. Between January 2013 and December 2014 761 patients with suspected CBP were studied. Of these patients 332 (43.6%) underwent a complete microbiological study and the major clinical signs and symptoms were collected. Eighteen point four percent of patients were diagnosed microbiologically with CBP, Enterococcus faecalis being the main aetiologic agent (37.7%), followed by Escherichia coli (22.2%). Ninety-six point seven percent of the CBP had positive semen cultures, while only 22.9% had positive urine post-semen cultures. Data of sensitivity, specificity, positive predictive value and negative predictive value of semen were 96.7%, 95.9%, 84.3% and 99.3%, respectively and urine post-semen 22.9%, 99.3%, 87.5% and 85.1%, respectively. Testicular perineum pain (44.3%), ejaculatory discomfort (27.9%) and haemospermia (26.2%) were highlighted as the patients' main clinical manifestations. Fractionated culture for the microbiological diagnosis of CBP could be simplified by the culture of urine pre-semen and semen, without the need for the culture of urine post-semen. The main aetiologic agent of CBP in our media was Enterococcus faecalis, followed by Escherichia coli. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  2. 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.

  3. Toward Predicting Popularity of Social Marketing Messages

    Science.gov (United States)

    Yu, Bei; Chen, Miao; Kwok, Linchi

    Popularity of social marketing messages indicates the effectiveness of the corresponding marketing strategies. This research aims to discover the characteristics of social marketing messages that contribute to different level of popularity. Using messages posted by a sample of restaurants on Facebook as a case study, we measured the message popularity by the number of "likes" voted by fans, and examined the relationship between the message popularity and two properties of the messages: (1) content, and (2) media type. Combining a number of text mining and statistics methods, we have discovered some interesting patterns correlated to "more popular" and "less popular" social marketing messages. This work lays foundation for building computational models to predict the popularity of social marketing messages in the future.

  4. Assessment of the effectiveness of the post-Fukushima food monitoring campaign in the first year after the nuclear accident: A hypothesis

    International Nuclear Information System (INIS)

    Steinhauser, Georg

    2016-01-01

    The purpose of this study was to assess whether or not the food monitoring campaign after the Fukushima nuclear accident has been successful in reducing the number of above-limit-food from reaching the consumers. The hypothesis of this study is that the fraction of “post-market” food can be used for this purpose, when the post-market fraction in the above-limit (p′) items is compared to the post-market fraction in the entity of food items (p) that have been screened for radionuclides ("1"3"4Cs and "1"3"7Cs). Indeed the post-market fraction in most vegetarian produce decreased significantly in the above-limit food items (p′/p   1), indicating a much lower effectiveness of the monitoring action for beef. The author speculates that, by following the governmental monitoring manual (which gives “meat” only second priority), the sudden exceedances caught the monitoring agencies unprepared and triggered a much higher density monitoring of beef with the delay of several weeks. Even then, many above limit items reached the market (mainly because the monitoring during this period had focused on the post-market). Therefore, it is likely that some above-limit beef has been consumed by the public. For other meat products, the fraction of post-market samples was very low, which does not allow for the validation of the effectiveness of the monitoring campaign. Overall, the monitoring seemed to have been more effective for vegetarian produce than for meat. - Highlights: • The fraction of post-market food above the regulatory indicates the effectiveness of the monitoring campaign. • Monitoring of vegetables has been more effective than of meat. • Beef had the highest fraction of exceedances in the post-market fraction.

  5. Sudden onset Oculo-cardiac Reflex post-traumatic eye injury in PNG: a case study and discussion.

    Science.gov (United States)

    Grogan, Aaron D

    2014-08-01

    This case study examines the onset of traumatic OCR--Oculo-cardiac Reflex--in the remote southern highlands of PNG. The spontaneous occurrence of OCR post-trauma in the clinical setting leads to sudden onset bradycardia, nausea and hypotension, resulting in cardiovascular compromise and deteriorating clinical conditions. Initial recognition of the characteristics of OCR will prepare the clinician to deal with the sequence of events that arise post the reflex initiation. Copyright © 2014 College of Emergency Nursing Australasia Ltd. Published by Elsevier Ltd. All rights reserved.

  6. Russia’s Financial Markets and Financial Institutions in 2013

    OpenAIRE

    Alexander Abramov

    2014-01-01

    This paper deals with a wide scope of issues, starting with the post-crisis recovery of Russia's financial market. The author analyzes the market for shares issued by Russian companies, investigates dependence on the global conjuncture of prices and inflow and outflow of foreign portfolio investment. He also studies currency exchange rate, looks at the competition on the domestic share market, and analyzes preliminary results of the merger of the RTS and MICEX. The article deals with the mark...

  7. Russia’s Financial Markets and Financial Institutions in 2012

    OpenAIRE

    Alexander Abramov

    2013-01-01

    This paper deals with a wide scope of issues, starting with the post-crisis recovery of Russia's financial market. The author analyzes the market for shares issued by Russian companies, investigates dependence on the global conjuncture of prices and inflow and outflow of foreign portfolio investment. He also studies currency exchange rate, looks at the competition on the domestic share market, and analyzes preliminary results of the merger of the RTS and MICEX. The article deals with the mark...

  8. Russia’s Money Markets and Financial Institutions in 2014

    OpenAIRE

    Alexander Abramov

    2015-01-01

    This paper deals with a wide scope of issues, starting with the post-crisis recovery of Russia's financial market. The author analyzes the market for shares issued by Russian companies, investigates dependence on the global conjuncture of prices and inflow and outflow of foreign portfolio investment. He also studies currency exchange rate, looks at the competition on the domestic share market, and analyzes preliminary results of the merger of the RTS and MICEX. The article deals with the mark...

  9. 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

  10. 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...

  11. Market Power in Power Markets: Evidence from Forward Prices of Electricity

    DEFF Research Database (Denmark)

    Christensen, Bent Jesper; Jensen, Thomas Elgaard; Mølgaard, Rune

    We examine the forward market for electricity for indications of misuse of market power, using a unique data set on OTC price indications posted by Elsam A/S, the dominant producer in Western Denmark, which is one of the price areas under the Nordic power exchange Nord Pool. The Danish Competition...... Council (the regulatory government agency) has ruled that Elsam has used its dominant position to obtain excessive spot prices over a period from July 2003 through December 2006. We show that significant forward premia exist, and that they are related both to spot market volatility and misuse of market...... are consistent across forward premium regressions and structural forward pricing models....

  12. Marketingo išlaidų mažinimo efektas post-recesiniu laikotarpiu

    OpenAIRE

    Černikovaitė, Miglė Eleonora; Jucaitytė, Indrė

    2011-01-01

    This article presents the important changes of the post-recession marketing and summarise the scientific research results in Lithuania and foreign countries, demonstrating the effect of reallocating marketing costs. Many of the ongoing studies show that companies that maintain their marketing budgets or increase them during a recession do far better than companies that reduce spending. Despite the fact, the reductions in marketing budget are among the most popular decision of solving short-te...

  13. 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

  14. AN EMPIRICAL STUDY OF MARKETING COMMUNICATIONS EFFECTIVENESS IN SLOVENIAN MARKET

    Directory of Open Access Journals (Sweden)

    Damjana Jerman

    2014-01-01

    Full Text Available This paper deals with the value or more specifically, the contribution of marketing communications strategy to effectiveness of marketing communications and hypothesizes that marketing communications strategy correlate with the effectiveness of marketing communications. The paper consists of two parts: the theoretical framework for the role of marketing communications strategy for the effectiveness of the marketing communications and the empirical analysis, based on the primary data collected. The concept of the marketing communication effectiveness assumes that there are variables that can have a positive influence on the effectiveness of marketing communications, which incorporates facets of the marketing communication strategy and bidirectional communications. The results suggest that Slovenian organisations which design and implement marketing communication strategy, also have more effective marketing communications. The development of marketing communications strategy was correlated with increased effectiveness of marketing communications in their organisation. Managerial implications are discussed along with directions for further research.

  15. Marketing and Effectuation: A Study of Marketing Practices Among Swedish Microbreweries

    OpenAIRE

    Aery, Sahil; And, Johanna

    2017-01-01

    The present study aims to analyse the marketing strategies of Swedish microbreweries and relate them to the entrepreneurial principles of effectuation and causation. The authors investigated eight microbreweries in Mälardalsregionen of Sweden, conducting interviews with members of the founding team or the management team at the microbreweries. The results of the study show that most breweries used effectual principles to describe their marketing efforts. Two effectual principles in particula...

  16. What marketing strategy for destinations with a negative image?

    OpenAIRE

    Seraphin, Hugues; Gowreesunkar, Vanessa; Hugues Seraphin

    2017-01-01

    Purpose\\ud This concluding article filters out meaningful marketing strategies that aim at re-positioning and re-establishing struggling tourism destinations with negative image. Drawing from a collection of case studies around the world, the article provides evidences from post-colonial, post-conflict and post-disaster destinations to finally anchor the overall conclusion of the theme issue.\\ud \\ud Design\\ud The article summarizes key issues faced by destinations plagued with a negative imag...

  17. [In vivo evaluation of carbon fiber posts].

    Science.gov (United States)

    Lai, V; Lugliè, P F; Chessa, G

    2002-05-01

    The use of carbon fiber posts allows morpho-functional restoration of endodontically treated teeth with an assembly of materials of a modulus of elasticity similar to that of dentin. The study clinically evaluated the percentage of survival of dental elements treated and reconstructed with endocanal carbon fiber posts. At the Dentistry Clinic of the University of Sassari 60 dental elements were selected from 46 subjects. The teeth, which had been treated endodontically with success for at least six months, were classified by parameters taken from the international literature and reconstructed using Tech 2000 carbon fiber posts and adhesive resinous systems recommended by the post manufacturer. The success rate was 98.4%. Almost half (49%) of the samples were single-rooted elements, 37.4% of the posts were 1.2 mm in diameter; in 78.3% the opposing contact was with a natural tooth; 100% of the elements had a type A dental structure. Third generation posts are a valid alternative to metallic posts and improve the prognosis of the treated element. The carbon fiber posts fixed with the composite, forming a single unit with the dental element, thus improving mid-term RESULTS. The technique is easy to use under clinical conditions and can be performed in a single session. So far, the method has provided promising clinical results, as this study demonstrated.

  18. Study of Rice Marketing System in Iran

    OpenAIRE

    Feizabadi, Yaser

    2011-01-01

    Rice comes second after wheat in Iran`s food consumption economy. Rising population and recent growth in GDP has made Iran one of the greatest rice importer countries all over the world. That is why rice marketing has always been a controversial issue in Iran`s agricultural economics. To study rice marketing system in Iran, this paper aims to calculate rice marketing margin, market efficiency and marketing cost coefficient in seaside Mazandaran province( where 70 percent of domestic rice prod...

  19. 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.

  20. Exploring barriers and facilitators to the clinical use of virtual reality for post-stroke unilateral spatial neglect assessment.

    Science.gov (United States)

    Ogourtsova, Tatiana; Archambault, Philippe S; Lamontagne, Anouk

    2017-11-07

    Hemineglect, defined as a failure to attend to the contralesional side of space, is a prevalent and disabling post-stroke deficit. Conventional hemineglect assessments lack sensitivity as they contain mainly non-functional tasks performed in near-extrapersonal space, using static, two-dimensional methods. This is of concern given that hemineglect is a strong predictor for functional deterioration, limited post-stroke recovery, and difficulty in community reintegration. With the emerging field of virtual reality, several virtual tools have been proposed and have reported better sensitivity in neglect-related deficits detection than conventional methods. However, these and future virtual reality-based tools are yet to be implemented in clinical practice. The present study aimed to explore the barriers/facilitators perceived by clinicians in the use of virtual reality for hemineglect assessment; and to identify features of an optimal virtual assessment. A qualitative descriptive process, in the form of focus groups, self-administered questionnaire and individual interviews was used. Two focus groups (n = 11 clinicians) were conducted and experts in the field (n = 3) were individually interviewed. Several barriers and facilitators, including personal, institutional, client suitability, and equipment factors, were identified. Clinicians and experts in the field reported numerous features for the virtual tool optimization. Factors identified through this study lay the foundation for the development of a knowledge translation initiative towards an implementation of a virtual assessment for hemineglect. Addressing the identified barriers/facilitators during implementation and incorporating the optimal features in the design of the virtual assessment could assist and promote its eventual adoption in clinical settings. Implications for rehabilitation A multimodal and active knowledge translation intervention built on the presently identified modifiable factors is

  1. The new age of tobacco marketing: Imagery on social media

    Directory of Open Access Journals (Sweden)

    Lesley James

    2018-03-01

    Full Text Available Background While many areas of tobacco marketing have been restricted, the rise of digital and social media has presented an opportunity for new marketing avenues. This study looked at celebrity social media culture and its contribution to tobacco marketing. Objectives: - Assess the prevalence of such marketing. - Assess who is being targeted, which audience segments. - Determine what types of tobacco products are being marketed. - Analyze themes or frames used to make these products appealing. Methods Qualitative and quantitative methods were used to assess the celebrity social media setting. The top 10 global celebrity personalities were included for assessment. Only Instagram accounts were included as sources for data collection. Instagram posts were reviewed for imagery of tobacco products, content, and audience targets. From this data a thematic analysis was conducted to assess frames and narratives used within marketing tactics. Review of social media posts was limited to a 3 year time frame starting October 1, 2014 and ending September 30, 2017. Results Tobacco related marketing remains present on social media within the celebrity culture. Many of the top 10 followed celebrities had portrayals of tobacco embedded within their profile and/or posts. Young females are overtly targeted and traditional themes such as fashion, glamour, fun, sex appeal and free-will continue to be used as marketing frames. Conclusions These findings demonstrate the need for intervention to monitor and restrict tobacco related marketing on social media. While it's difficult to determine the source of tobacco marketing social media (industry placed or without paid placement it warrants a discussion about influence of the celebrity and digital cultures on health behaviours. In the absence of regulation, celebrities should be considerate and responsible for the harmful imagery shared over social media.

  2. A framework for studying relationship marketing dyads

    NARCIS (Netherlands)

    Lindgreen, A.

    2001-01-01

    Although coined more than 15 years ago, relationship marketing remains an ambiguous concept with plenty of rhetoric but few publications on empirical evidence in support of a relationship marketing paradigm shift. A research project is currently studying marketing dyads in the international food

  3. [Post-mortem microbiology analysis].

    Science.gov (United States)

    Fernández-Rodríguez, Amparo; Alberola, Juan; Cohen, Marta Cecilia

    2013-12-01

    Post-mortem microbiology is useful in both clinical and forensic autopsies, and allows a suspected infection to be confirmed. Indeed, it is routinely applied to donor studies in the clinical setting, as well as in sudden and unexpected death in the forensic field. Implementation of specific sampling techniques in autopsy can minimize the possibility of contamination, making interpretation of the results easier. Specific interpretation criteria for post-mortem cultures, the use of molecular diagnosis, and its fusion with molecular biology and histopathology have led to post-mortem microbiology playing a major role in autopsy. Multidisciplinary work involving microbiologists, pathologists, and forensic physicians will help to improve the achievements of post-mortem microbiology, prevent infectious diseases, and contribute to a healthier population. Crown Copyright © 2012. Published by Elsevier Espana. All rights reserved.

  4. [Clinical study of post-stroke upper limb spasmodic hemiplegia treated with jingou diaoyu needling technique and Bobath therapy].

    Science.gov (United States)

    Sun, Runjie; Tian, Liang; Fang, Xiaoli; Du, Xiaozheng; Zhu, Bowen; Song, Zhongyang; Xu, Xuan; Qin, Xiaoguang

    2017-04-12

    To compare the difference in the clinical efficacy on post-stroke upper limb spasmodic hemiplegia between the combined therapy of jingou diaoyu needling technique and Bobath technology and simple Bobath technology. Sixty patients were randomized into an observation group and a control group, 30 cases in each one. The usual medication of neurological internal medicine was used in the two groups. In the control group, Bobath facilitation technology was applied to the rehabilitation training. In the observation group, on the basis of the treatment as the control group, jingou diaoyu needling technique was used to stimulate Zhongfu (LU 1), Tianfu (LU 3), Chize (LU 5), Quchi (LI 11), Jianshi (PC 5) and Daling (PC 7). The treatment was given once a day; 5 treatments made one session and totally 4-week treatment was required in the two groups. The modified Ashworth scale, the modified Fugle-Meyer assessment (FMA) and the Barthel index (BI) were adopted to evaluate the muscular tension, the upper limb motor function and the activities of daily living (ADL) before and after treatment in the two groups. The clinical efficacy was compared between the two groups. Compared with those before treatment, the modified Ashworth scale, Fugl-Meyer score and BI score were all improved after treatment in the two groups (all P Bobath therapy achieve the superior efficacy on post-stroke upper limb spasmodic hemiplegia as compared with the simple application Bobath therapy. This combined treatment effectively relieve spasmodic state and improve the upper limb motor function and the activities of daily living.

  5. Futures market efficiency diagnostics via temporal two-point correlations. Russian market case study

    OpenAIRE

    Kopytin, Mikhail; Kazantsev, Evgeniy

    2013-01-01

    Using a two-point correlation technique, we study emergence of market efficiency in the emergent Russian futures market by focusing on lagged correlations. The correlation strength of leader-follower effects in the lagged inter-market correlations on the hourly time frame is seen to be significant initially (2009-2011) but gradually goes down, as the erstwhile leader instruments -- crude oil, the USD/RUB exchange rate, and the Russian stock market index -- seem to lose the leader status. An i...

  6. The fate of prospective spine studies registered on www.ClinicalTrials.gov.

    Science.gov (United States)

    Ohnmeiss, Donna D

    2015-03-01

    There has been concern expressed about research ethics with respect to not fully reporting data collected during clinical studies. One site available for all clinical trials is ClinicalTrials.gov. The original purpose of this site was to facilitate patients seeking a trial for the treatment of their particular condition. The internationally available site offers general information about the study, sponsor name, principal investigator, patient selection criteria, enrollment goal, study design, outcome measures, participating centers, initiation date, date posted, date completed, and other pertinent data. The site can be used to identify studies conducted for a particular condition or intervention. The purpose of this study was to investigate the fate of spine-related studies registered on www.ClinicalTrials.gov, with particular focus on the publication rate of completed trials. Analysis and classification of clinical studies posted on an international research registry Web page and literature search for related publications. Not applicable. The primary outcome measure was publication of the study registered on ClinicalTrials.gov. Multiple searches were conducted on ClinicalTrials.gov Web site to identify studies related to commonly treated spinal conditions, including herniated disc, degenerative disc disease, stenosis, and spondylolisthesis. Studies related to tumors, fractures, or that included nonspine conditions were not included. For studies classified as completed more than 18 months before this review, literature searches were conducted to determine if the results of the study had been published and factors related to publication. The author has no financial conflict related to this work. There were 263 spine-related studies identified from searches on the ClinicalTrials.gov site. Data on the site had the studies classified as follows: 72 completed, 70 active, not recruiting (generally indicates collecting follow-up data), 74 recruiting, 11 recruiting by

  7. Market Orientation Impact on Radical and Incremental Marketing Innovation: A Study of Saudi Arabia Hospital Marketing Efforts

    OpenAIRE

    Alshahry Abdullah saeed A; Wang Aimin

    2015-01-01

    We conducted an empirical study to measure influence of market orientation on marketing innovation in hospitals in Saudi Arabia. The sample includes 109 hospital workers that have been identified as having an adequate knowledge of the subject of research. In particular we explain the impact of customer orientation, inter-functional orientation and competitor orientation on marketing innovation. Furthermore the moderating effects of centralization and formalization on those relationships are e...

  8. 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.

  9. Post-Secondary Education and Rural-Urban Migration

    Science.gov (United States)

    Synge, J.

    1974-01-01

    This study examined education and career plans of Scottish rural youth who entered post-secondary education in order to determine the extent to which the educational system offers rural youth not only specific training but only entry to the urban labour market. (Author/RK)

  10. The Study of Consumer’s Post-Purchase Evaluation toward Brand Equity of Five Stars Hotels in Thailand

    OpenAIRE

    Dejsiriphun, Chonnikarn; Suviratvithayakit, Kritsana

    2011-01-01

    Date: May 30, 2011 Program: MIMA- International Marketing Course Name: Master Thesis (EFO705) Title: The Study of Consumer’s Post-Purchase Evaluation toward Brand Equity of Five Stars Hotels in Thailand Research Problem: What are the characteristics of brand equity of five star luxury hotels in Thailand and which components of brand equity are the majority concerns from customers’ evaluation? Purpose: The study aims to investigate and analyze the interrelationship of brand equity of five star...

  11. SOME ASPECTS OF THE MARKETING STUDIES FOR THE PHARMACEUTICAL MARKET OF ANTIVIRAL DRUGS

    Directory of Open Access Journals (Sweden)

    A. G. Salnikova

    2015-01-01

    Full Text Available Antiviral drugs are widely used in medicinal practice. They suppress the originator and stimulate the protection of an organism. The drugs are used for the treatment of flu and ARVI, herpetic infections, virus hepatitis, HIV-infection. Contemporary pharmaceutical market is represented by a wide range of antiviral drugs. Marketing studies are conducted to develop strategies, used for the enhancement of pharmacy organization activity efficiency. Conduction of the marketing researches of pharmaceutical market is the purpose of this study. We have used State Registry of Drugs, State Record of Drugs, List of vital drugs, questionnaires of pharmaceutical workers during our work. Historical, sociological, mathematical methods, and a method of expert evaluation were used in the paper. As the result of the study we have made the following conclusions. We have studied and generalized the literature data about classification and application of antiviral drugs, marketing, competition. The assortment of antiviral drugs on the pharmaceutical market of the Russian Federation was also studied. We have conducted an analysis for the obtainment of the information about antiviral drugs by pharmaceutical workers. We have determined the competitiveness of antiviral drugs, and on the basis of the research conducted we have submitted an offer for pharmaceutical organizations to form the range of antiviral drugs.

  12. Quantitative echocardiographic measures in the assessment of single ventricle function post-Fontan: Incorporation into routine clinical practice.

    Science.gov (United States)

    Rios, Rodrigo; Ginde, Salil; Saudek, David; Loomba, Rohit S; Stelter, Jessica; Frommelt, Peter

    2017-01-01

    Quantitative echocardiographic measurements of single ventricular (SV) function have not been incorporated into routine clinical practice. A clinical protocol, which included quantitative measurements of SV deformation (global circumferential and longitudinal strain and strain rate), standard deviation of time to peak systolic strain, myocardial performance index (MPI), dP/dT from an atrioventricular valve regurgitant jet, and superior mesenteric artery resistance index, was instituted for all patients with a history of Fontan procedure undergoing echocardiography. All measures were performed real time during clinically indicated studies and were included in clinical reports. A total of 100 consecutive patients (mean age = 11.95±6.8 years, range 17 months-31.3 years) completed the protocol between September 1, 2014 to April 29, 2015. Deformation measures were completed in 100% of the studies, MPI in 93%, dP/dT in 55%, and superior mesenteric artery Doppler in 82%. The studies were reviewed to assess for efficiency in completing the protocol. The average time for image acquisition was 27.4±8.8 (range 10-62 minutes). The average time to perform deformation measures was 10.8±5.5 minutes (range 5-35 minutes) and time from beginning of imaging to report completion was 53.4±13.7 minutes (range 27-107 minutes). There was excellent inter-observer reliability when deformation indices were blindly repeated. Patients with a single left ventricle had significantly higher circumferential strain and strain rate, longitudinal strain and strain rate, and dP/dT compared to a single right ventricle. There were no differences in quantitative indices of ventricular function between patients 10 years post-Fontan. Advanced quantitative assessment of SV function post-Fontan can be consistently and efficiently performed real time during clinically indicated echocardiograms with excellent reliability. © 2016, Wiley Periodicals, Inc.

  13. [Construction and realization of real world integrated data warehouse from HIS on re-evaluation of post-maketing traditional Chinese medicine].

    Science.gov (United States)

    Zhuang, Yan; Xie, Bangtie; Weng, Shengxin; Xie, Yanming

    2011-10-01

    To construct real world integrated data warehouse on re-evaluation of post-marketing traditional Chinese medicine for the research on key techniques of clinic re-evaluation which mainly includes indication of traditional Chinese medicine, dosage usage, course of treatment, unit medication, combined disease and adverse reaction, which provides data for reviewed research on its safety,availability and economy,and provides foundation for perspective research. The integrated data warehouse extracts and integrate data from HIS by information collection system and data warehouse technique and forms standard structure and data. The further research is on process based on the data. A data warehouse and several sub data warehouses were built, which focused on patients' main records, doctor orders, diseases diagnoses, laboratory results and economic indications in hospital. These data warehouses can provide research data for re-evaluation of post-marketing traditional Chinese medicine, and it has clinical value. Besides, it points out the direction for further research.

  14. 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)

  15. Word-of-mouth marketing: low-cost technique proves an effective way to promote teen clinic.

    Science.gov (United States)

    2006-01-01

    From the outset, the team at the Longmont (CO) Teen Clinic faced a two-fold marketing dilemma. The first problem was a small budget. As a nonprofit with limited funds, the staff knew that they would have to get creative to effectively reach their target audience and fulfill the clinic's mission of battling unwanted teen pregnancies and sexually transmitted diseases (STD) among area women aged 19 and younger.

  16. The effect of marketing innovation, market orientation, and social capital on competitive advantage and marketing performance: A study in MSMEs of embroidery Central Java Province

    Directory of Open Access Journals (Sweden)

    Ag. Sunarno Handoyo

    2015-12-01

    Full Text Available This study deals with marketing innovation, market orientation, and social capital in affecting the competitive advantage and marketing performance in Micro, Small, and Medium Enterprises (MSMEs of embroidery in Central Java Province. In this respect, this study tried to test and analyze the effect of marketing innovation, market orienta-tion, and social capital on competitive advantage and marketing performance in Micro, Small, and Medium Enterprises (MSMEs of embroidery in Central Java Province. The samples are 150 respondents as the owners of the embroidery business in Central Java Province. The technical analysis used is Structure Equations Modeling with AMOS Software version 22. The results show that: (1 marketing innovation has significant effect on competitive advantage; (2 market orientation has significant effect on competi-tive advantage; (3 social capital has significant effect on competitive advantage; (4 competitive advantage has significant effect on marketing performance; (5 marketing innovation has significant effect on marketing performance; (6 market orientation has significant effect on marketing performance; (7 social capital has no significant effect on marketing performance. The implication of this study is that the MSMEs of embroidery could improve marketing performance by increasing marketing innovation, market orientation, social capital and competitive advantage. This study also shows that competitive advantage is an intervening variable on marketing performance.

  17. Intercultural marketing: Culture and its influence on the efficiency of Facebook marketing communication

    Directory of Open Access Journals (Sweden)

    Copuš Lukáš

    2017-06-01

    Full Text Available The paper deals with intercultural marketing, which is a combination of two different phenomena - marketing and culture. The first objective of the paper lies in providing theoretical definitions of the above-mentioned areas. Subsequently, the aim is to analyse marketing communication of the selected automotive companies and determine its efficiency on social media within the context of cultural differences and cultural forms as their manifestations. A considerable amount of literature has been published on intercultural marketing, but only a few studies have concentrated on the connection with modern communication tools – i.e. social media. The data come from a research conducted online focused on Facebook. In total 2606 posts on twenty Facebook profiles of selected automotive companies were analysed. Our findings show that the use of standardization and adaptation is not related to the efficiency of marketing communication of individual Facebook profiles. One of the factors that determine the efficiency is cultural specifics visible by cultural forms which were interpreted for each selected culture. The contribution and the originality of this paper lies in providing theoretical and practical information about cultural differences on social media not only for marketing managers operating in different cultures, but also for researchers interested in intercultural marketing.

  18. Studi Pemilihan Layanan Jasa Pengiriman Oleh Pelaku Bisnis Online Sebagai Sarana Distribusi Produk Menggunakan Strategi Marketing Mix di DKI Jakarta

    Directory of Open Access Journals (Sweden)

    Vidyantina Heppy Anandhita

    2013-09-01

    The choice of delivery services company by online businesses with Marketing Mix strategies has been studied based in Jakarta. The study was conducted with purposive sampling for 30 respondent. It can be conclude that Place and Product marketing mix variabel were the variable with the highest ratings among respondents to select most often used delivery service. While the Price factor is not a top priority, it can be seen from consumers that provide appraisal for delivery services rates of PT Pos Indonesia was better (cheaper than the delivery service companies often used. However , only 30 % of online businesses who uses the PT Pos Indonesia delivery service to distribute its products to customers. In this study , it is known that PT Pos Indonesia as a post state-owned company in Indonesia, contributes only 3.5 % of the  product delivery flow of online business . It is recommended for PT Pos Indonesia to be able to increase the promotion and cooperation with online businesses and improve the quality of mobile services post.

  19. Frequency and clinical manifestations of post-poliomyelitis syndrome in a brazilian tertiary care center

    Directory of Open Access Journals (Sweden)

    Abrahão Augusto Juviniano Quadros

    2012-08-01

    Full Text Available OBJECTIVE: To determine the frequency and clinical manifestations of patients with post-poliomyelitis syndrome (PPS in a Brazilian division of neuromuscular disorders. METHODS: A total of 167 patients with prior history of paralytic poliomyelitis was investigated for PPS, based on international diagnostic criteria. Other variables analyzed were: gender, race, age at poliomyelitis infection, age at PPS onset, and PPS symptoms. RESULTS: One hundred and twenty-nine patients presented PPS, corresponding to 77.2% of the studied population. 62.8% were women and 37.2% were men. Mean age of patients with PPS at onset of PPS symptoms was 39.9±9.69 years. Their main clinical manifestations were: new weakness in the previously affected limbs (69% and in the apparently not affected limbs (31%; joint pain (79.8%; fatigue (77.5%; muscle pain (76%; and cold intolerance (69.8%. CONCLUSIONS: Most patients of our sample presented PPS. In Brazil, PPS frequency and clinical features are quite similar to those of other countries.

  20. Electronic health records to facilitate clinical research.

    Science.gov (United States)

    Cowie, Martin R; Blomster, Juuso I; Curtis, Lesley H; Duclaux, Sylvie; Ford, Ian; Fritz, Fleur; Goldman, Samantha; Janmohamed, Salim; Kreuzer, Jörg; Leenay, Mark; Michel, Alexander; Ong, Seleen; Pell, Jill P; Southworth, Mary Ross; Stough, Wendy Gattis; Thoenes, Martin; Zannad, Faiez; Zalewski, Andrew

    2017-01-01

    Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research.

  1. Study on the Chinese Goods Market Structure and Related Integrated Marketing Strategy

    OpenAIRE

    Qishen Zhou; Mingxing Yang

    2013-01-01

    This study aims to investigate the Chinese goods market structure and related integrated marketing strategy. In recent years, it is becoming more and more popular for Chinese consumers to go on luxury consuming in a variety of large cities in China, showing the increasing demand of luxury for Chinese people possessed relatively high fortune. Further, dozens of international famous luxury brands are pouring into the Chinese market such as LVMH and Gucci, recognizing the huge consumption demand...

  2. Post-traumatic stress disorder in U.S. soldiers with post-traumatic headache.

    Science.gov (United States)

    Rosenthal, Jacqueline F; Erickson, Jay C

    2013-01-01

    To determine the impact of post-traumatic stress disorder (PTSD) on headache characteristics and headache prognosis in U.S. soldiers with post-traumatic headache. PTSD and post-concussive headache are common conditions among U.S. Army personnel returning from deployment. The impact of comorbid PTSD on the characteristics and outcomes of post-traumatic headache has not been determined in U.S. Army soldiers. A retrospective cohort study was conducted among 270 consecutive U.S. Army soldiers diagnosed with post-traumatic headache at a single Army neurology clinic. All subjects were screened for PTSD at baseline using the PTSD symptom checklist. Headache frequency and characteristics were determined for post-traumatic headache subjects with and without PTSD at baseline. Headache measures were reassessed 3 months after the baseline visit, and were compared between groups with and without PTSD. Of 270 soldiers with post-traumatic headache, 105 (39%) met screening criteria for PTSD. There was no significant difference between subjects with PTSD and those without PTSD with regard to headache frequency (17.2 vs 15.7 headache days per month; P = .15) or chronic daily headache (58.1% vs 52.1%; P = .34). Comorbid PTSD was associated with higher headache-related disability as measured by the Migraine Disability Assessment Score. Three months after the baseline neurology clinic visit, the number of subjects with at least 50% reduction in headache frequency was similar among post-traumatic headache cases with and without PTSD (25.9% vs 26.8%). PTSD is prevalent among U.S. Army soldiers with post-traumatic headache. Comorbid PTSD is not associated with more frequent headaches or chronic daily headache in soldiers evaluated at a military neurology clinic for chronic post-traumatic headache. Comorbid PTSD does not adversely affect short-term headache outcomes, although prospective controlled trials are needed to better assess this relationship. © 2013 American Headache

  3. Clinical value of FDG-PET in the follow up of post-operative patients with endometrial cancer

    International Nuclear Information System (INIS)

    Saga, Tsuneo; Higashi, Tatsuya; Ishimori, Takayoshi

    2003-01-01

    The clinical usefulness of FDG-PET in the follow up of post-operative patients with endometrial cancer was retrospectively evaluated. Twenty-one post-operative patients with endometrial cancer received 30 FDG-PET examinations to evaluate recurrence or response to treatment. The findings of FDG-PET were compared with their serum levels of tumor markers, CT and/or MRI findings, and the final outcome. Results of FDG-PET were also correlated with the clinical course of each patient. In detecting recurrent lesions and evaluating treatment responses, FDG-PET, with the help in anatomic information by CT/MRI, showed better diagnostic ability (sensitivity 100.0%, specificity 88.2%, accuracy 93.3%) compared with combined conventional imaging (sensitivity 84.6%, specificity 85.7%, accuracy 85.0%) and tumor markers (sensitivity 100.0%, specificity 70.6%, accuracy 83.3%). FDG-PET had no false-negative results, suggesting the possibility of its use as the first-line examination in a patient's follow-up. FDG-PET could detect unknown lesions in 4 cases, and, as reported for other malignancies, FDG-PET affected the patient management in one-third of the cases. Furthermore, the results of FDG-PET correlated well with the clinical outcome of the patients, with patients with negative PET results tending to show disease-free courses. These results suggest that, despite the limited number of patients studied, FDG-PET was accurate in detecting recurrence and evaluating therapeutic response, and could afford important information in the management of post-operative patients with endometrial cancer. FDG-PET also appeared to have a possibility to predict the outcome of each patient. (author)

  4. Post-traumatic tricuspid valve insufficiency. 2 cases of delayed clinical manifestation.

    OpenAIRE

    Bortolotti, U; Scioti, G; Milano, A; Guglielmi, C; Benedetti, M; Tartarini, G; Balbarini, A

    1997-01-01

    We present 2 cases of tricuspid insufficiency following blunt chest trauma: 1 was diagnosed 5 months after the trauma and the other, 20 years after the trauma. In both patients, the tricuspid valve was replaced with a porcine bioprosthesis, because valve repair was not considered feasible. These cases emphasize the variability of clinical presentation of post-traumatic tricuspid valve insufficiency and indicate the need for close follow-up of patients after major thoracic trauma.

  5. [Ethical issues in a market dispute between clinical laboratories and a health plan: case report].

    Science.gov (United States)

    Pinheiro, Malone Santos; de Brito, Ana Maria Guedes; Jeraldo, Verônica de Lourdes Sierpe; Pinheiro, Kariny Souza

    2011-01-01

    In Brazil the private health plans appear as an alternative to the public health assistance. This segment suffered great intensification in the seventies and eighties, culminating in the entry of large insurance company in the scenario of supplementary medicine. Quickly, the service providers associated with these insurance companies, consolidating them in the market and triggering a relationship of dependency. This article analyzed, in the form of a case report, a marketing dispute between clinical laboratories and a health plan, emphasizing the moral and ethical aspects involved in this episode.

  6. Marketing occupational health care.

    Science.gov (United States)

    Norris, M J; Harris, J C

    1981-01-01

    A very basic part of marketing success is determining areas of your business in which you have a competitive advantage. In drafting a marketing plan for the Denver Clinic, the competitive advantages group practices have in the area of occupational health were quickly realized. This competitive edge is presented along with the Denver Clinic's marketing strategies and plans to capitalize on occupational healthcare advantages.

  7. An empirical study of marketing communications effectiveness in Slovenian market

    OpenAIRE

    Jerman, Damjana; Završnik, Bruno

    2017-01-01

    This paper deals with the value or more specifically, the contribution of marketing communications strategy to effectiveness of marketing communications and hypothesizes that marketing communications strategy correlate with the effectiveness of marketing communications. The paper consists of two parts: the theoretical framework for the role of marketing communications strategy for the effectiveness of the marketing communications and the empirical analysis, based on the primary data collected...

  8. Asymmetric price responses, market integration and market power: A study of the U.S. natural gas market

    International Nuclear Information System (INIS)

    Murry, Donald; Zhu, Zhen

    2008-01-01

    We studied the market performance at selected, representative natural gas trading hubs in the U.S. and documented different price behaviors among various hubs. With NYMEX prices as the competitive benchmark, we found empirically that the spot price responses at some trading hubs were systematically asymmetric, thus demonstrating a market advantage by either buyers or sellers. We further found that the presence of market power was a very plausible explanation for this price behavior at some hubs. (author)

  9. Post-exercise hypotensive responses following an acute bout of aquatic and overground treadmill walking in people post-stroke: a pilot study.

    Science.gov (United States)

    Lai, Byron; Jeng, Brenda; Vrongistinos, Konstantinos; Jung, Taeyou

    2015-06-01

    The purpose of this study is to investigate the effects of a single-bout of aquatic treadmill walking (ATW) and overground treadmill walking (OTW) on the magnitude and duration of post-exercise ambulatory blood pressure (BP) in people post-stroke. Seven people post-stroke participated in a cross-sectional comparative study. BP was monitored for up to 9 hours after a 15-minute bout of ATW and OTW at approximately 70% of maximal oxygen consumption (VO2max), performed on separate days. Mean systolic and diastolic BP values were compared between both exercise conditions and a day without exercise (control). Three hours after OTW, mean SBP increased by 9% from pre-exercise baseline compared to a 3% decrease during the control day (P stroke can sustain sufficient walking intensities necessary to reduce BP following cardiovascular exercise. Also, these data suggest that ATW can elicit clinically meaningful reductions in DBP and night-time SBP. Thus, it is recommended for clinicians to consider ATW as a non-pharmaceutical means to regulate DBP and promote nighttime dipping of SBP in people post-stroke. However, caution is advised during the immediate hours after exercise, a period of possible BP inflation.

  10. Patients' quality of life post thyroidectomy.

    LENUS (Irish Health Repository)

    Cashman, E C

    2011-01-01

    This study was designed to evaluate health related quality of life post thyroidectomy for hyperthyroidism with respect to clinical benefit and patient satisfaction. This is one of the first such studies in the literature evaluating quality of life post thyroidectomy for hyperthyroidism.

  11. A global assessment of market accessibility and market influence for global environmental change studies

    Energy Technology Data Exchange (ETDEWEB)

    Verburg, Peter H [Institute for Environmental Studies, Amsterdam Global Change Institute, VU University Amsterdam, De Boelelaan 1087, 1081 HV Amsterdam (Netherlands); Ellis, Erle C [Department of Geography and Environmental Systems, University of Maryland, Baltimore County, Baltimore, MD 21250 (United States); Letourneau, Aurelien, E-mail: Peter.Verburg@ivm.vu.nl [UMR 5175 Centre d' Ecologie Fonctionnelle and Evolutive, Centre National de la Recherche Scientifique, 1919 Route de Mende, 34293 Montpellier cedex 5 (France)

    2011-07-15

    Markets influence the global patterns of urbanization, deforestation, agriculture and other land use systems. Yet market influence is rarely incorporated into spatially explicit global studies of environmental change, largely because consistent global data are lacking below the national level. Here we present the first high spatial resolution gridded data depicting market influence globally. The data jointly represent variations in both market strength and accessibility based on three market influence indices derived from an index of accessibility to market locations and national level gross domestic product (purchasing power parity). These indices show strong correspondence with human population density while also revealing several distinct and useful relationships with other global environmental patterns. As market influence grows, the need for high resolution global data on market influence and its dynamics will become increasingly important to understanding and forecasting global environmental change.

  12. A global assessment of market accessibility and market influence for global environmental change studies

    Science.gov (United States)

    Verburg, Peter H.; Ellis, Erle C.; Letourneau, Aurelien

    2011-07-01

    Markets influence the global patterns of urbanization, deforestation, agriculture and other land use systems. Yet market influence is rarely incorporated into spatially explicit global studies of environmental change, largely because consistent global data are lacking below the national level. Here we present the first high spatial resolution gridded data depicting market influence globally. The data jointly represent variations in both market strength and accessibility based on three market influence indices derived from an index of accessibility to market locations and national level gross domestic product (purchasing power parity). These indices show strong correspondence with human population density while also revealing several distinct and useful relationships with other global environmental patterns. As market influence grows, the need for high resolution global data on market influence and its dynamics will become increasingly important to understanding and forecasting global environmental change.

  13. A global assessment of market accessibility and market influence for global environmental change studies

    International Nuclear Information System (INIS)

    Verburg, Peter H; Ellis, Erle C; Letourneau, Aurelien

    2011-01-01

    Markets influence the global patterns of urbanization, deforestation, agriculture and other land use systems. Yet market influence is rarely incorporated into spatially explicit global studies of environmental change, largely because consistent global data are lacking below the national level. Here we present the first high spatial resolution gridded data depicting market influence globally. The data jointly represent variations in both market strength and accessibility based on three market influence indices derived from an index of accessibility to market locations and national level gross domestic product (purchasing power parity). These indices show strong correspondence with human population density while also revealing several distinct and useful relationships with other global environmental patterns. As market influence grows, the need for high resolution global data on market influence and its dynamics will become increasingly important to understanding and forecasting global environmental change.

  14. Therapeutic Effect of Virtual Reality on Post-Stroke Patients: Randomized Clinical Trial.

    Science.gov (United States)

    Pedreira da Fonseca, Erika; Ribeiro da Silva, Nildo Manoel; Pinto, Elen Beatriz

    2017-01-01

    The study aimed to check the therapeutic effect of virtual reality associated with conventional physiotherapy on gait balance and the occurrence of falls after a stroke. This was a randomized, blinded clinical trial conducted with post-stroke patients, randomized into two groups-treatment group and control group-and subjected to balance assessments by the Dynamic Gait Index and investigation of falls before and after 20 intervention sessions. Statistically significant difference was considered at P < .05. We selected 30 patients, but there were three segment losses, resulting in a total of 13 patients in the control group and 14 in the treatment group. There was an improvement in gait balance and reduced occurrence of falls in both groups. After intervention, the differences in gait balance in the control group (P = .047) and the reduction in the occurrence of falls in the treatment group (P = .049) were significant. However, in intergroup analysis, there was no difference in the two outcomes. Therapy with games was a useful tool for gait balance rehabilitation in post-stroke patients, with repercussions on the reduction of falls. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  15. 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.

  16. Promotion of Critical Thinking in Clinical Nursing Post Conferences: A Peer Interactive Approach

    Science.gov (United States)

    Stevens, Joanne

    2009-01-01

    Several workshops presented at the 2005 Lilly Conference on College Teaching in Oxford, Ohio, provided the inspiration for redesigning the clinical post conference for a foundational nursing course. Given the complexity and acuity of patient conditions today, fostering critical thinking in student nurses is central to quality patient care. The…

  17. Survey of young patients with polio and a foreign background at a Swedish post-polio outpatient clinic.

    Science.gov (United States)

    Werhagen, Lars; Borg, Kristian

    2016-10-01

    Nowadays, polio survivors aged under 60 years are non-native Swedes which pose new aspects and challenges to a post-polio outpatient clinic. To analyze the medical data, walking aids, occupational, and family situation in non-native polio survivors aged less than 60 years at a Swedish post-polio outpatient clinic. Retrospective data analysis. Data were retrieved from medical records at the post-polio outpatient clinic. Actual age, age at acute polio infection, walking capacity, pain, concomitant diseases, working and family situation, and ethnical origin were analyzed. Data are presented in numbers and percentage. 153 patients were included. Mean age was 45 (17-60) years, and mean age at acute polio infection was 2 (0-12) years. Paresis of the lower extremities was the most common disability. 10 % were wheelchair dependent. Pain occurred in 70 % with a mean intensity of 55 measured with the visual analog scale. Hypertension was the most common concomitant disease. Half of the polio survivors were working at least part time, and roughly half were singles. Data were comparable with data earlier published in Swedish native polio survivors. Non-native polio survivors aged under 60 years showed similarities in age at acute polio infection, paresis, prevalence, and intensity of pain when compared with native Swedish polio survivors. They were, however, younger, and were less often working and married/cohabitants than native Swedish polio survivors. The results of this study underline the importance of social and vocational rehabilitation tailoring rehabilitation suitable for polio survivors with a foreign background.

  18. 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...

  19. Sarcopenia and post-hospital outcomes in older adults: A longitudinal study.

    Science.gov (United States)

    Pérez-Zepeda, Mario Ulises; Sgaravatti, Aldo; Dent, Elsa

    Sarcopenia poses a significant problem for older adults, yet very little is known about this medical condition in the hospital setting. The aims of this hospital-based study were to determine: (i) the prevalence of sarcopenia; (ii) factors associated with sarcopenia; and (iii) the association of sarcopenia with adverse clinical outcomes post-hospitalisation. This is a longitudinal analysis of consecutive patients aged ≥70 years admitted to a Geriatric Management and Evaluation Unit (GEMU) ward. Sarcopenia was classified using the European Working Group on Sarcopenia in Older People (EWGSOP) algorithm, which included: handgrip strength, gait speed, and muscle mass using Bioelectrical Impedance Analysis (BIA). Outcomes were assessed at 12-months post-hospital discharge, and included both mortality and admission to a hospital Emergency Department (ED). Kaplan-Meier methods were used to estimate survival, with Cox proportion hazard models then applied. All regression analyses controlled for age, sex, and co-morbidity. 172 patients (72% female) with a mean (SD) age of 85.2 (6.4) years were included. Sarcopenia was present in 69 (40.1%) of patients. Patients with sarcopenia were twice as likely to die in the 12-months post-hospitalisation (HR, 95% CI=2.23, 1.15-4.34), but did not have an increased likelihood of ED admission. Sarcopenia showed an independent association with 12-month post-hospital mortality in older adults. With the new recognition of sarcopenia as a medical condition with its own unique ICD-10-CM code, awareness and diagnosis of sarcopenia in clinical settings is paramount. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  20. Beyond post-marketing research and MedWatch: Long-term studies of drug risks.

    Science.gov (United States)

    Resnik, David B

    2007-10-01

    Critics of the drug safety system have discussed many different potential reforms, ranging from mandatory registration of clinical trials to increasing the power of regulatory agencies, but few have discussed one of the most important ways of enhancing safety: increasing the number of long-term studies of medications. Long-term studies of the risks and benefits of drugs can provide useful information for regulators, healthcare professionals, and patients. Government funding agencies should lead the effort to conduct long-term studies of drugs, but private companies should also be required to lend financial support. Because cost-effectiveness is likely to be an important consideration in conducting this research, funding agencies should focus, at first, on drugs that are used to treat common, chronic conditions.

  1. 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.

  2. A CLINICAL COMPARATIVE STUDY OF ANALGESIC EFFECT OF TRAMADOL AND PENTAZOCINE IN POST - OPERATIVE PATIENTS FOLLOWING UPPER ABDOMINAL SURGERY

    Directory of Open Access Journals (Sweden)

    Jamuna

    2015-06-01

    Full Text Available The post - operative pain can be treated by various approaches. Aim of this randomised prospective study was to compare two drugs (Tramadol and Pentazocine . 100 adult patients of both sexes of ASA status 1 & 2 posted for elective upper abdominal surgery were randomly assigned into two groups of 50 each, where Group 1 received Tramadol intravenously and Group 2 received Pentazocine intravenously as post - opera tive pain management. The efficacy of the analgesic effect of intravenous Tramadol & Pentazocine was compared during post - operative pain management. It was observed that Tramadol has got more potent analgesic action compared to equianalgesic dose of Pentaz ocine.

  3. An investigation of strategies used in alcohol brand marketing and alcohol-related health promotion on Facebook.

    Science.gov (United States)

    Lim, Megan Sc; Hare, James D; Carrotte, Elise R; Dietze, Paul M

    2016-01-01

    Alcohol brands are incorporating social networking sites (SNS) into their marketing programmes. SNS are also being used to reduce alcohol consumption and harms by health promotion organisations. Marketing via SNS can attempt to influence consumers using a range of strategies from traditional marketing, social media, and behaviour change theory. This study systematically quantifies marketing strategies used by alcohol brands and health promoters on Facebook. We identified the 10 most popular alcohol brands and health promotion organisations in Australia on Facebook and extracted all posts from April 2014. A framework was developed, listing 33 SNS marketing strategies. The frequency of use of each strategy in posts was counted for all profiles. The median number of fans of alcohol brands was 189,290 compared with 7562 for health promotion pages. A total of 210 Facebook posts were analysed. Popular marketing strategies included visual attraction, connecting with other organisations, and links to culture and events. Time-specific and day-specific posts and tweets were used more regularly by alcohol brands than health promotion agencies. Alcohol brands remain substantially more popular than health promotion organisations, and this difference is likely driven by offline factors rather than specific use of marketing strategies. However, health promotion organisations can learn from the strategies used by popular brands, particularly in the use of time and day-specific content.

  4. Risk factors associated with short-term post-treatment outcomes of clinical mastitis.

    Science.gov (United States)

    Pinzón-Sánchez, C; Ruegg, P L

    2011-07-01

    The objectives of this study were to characterize 60-d outcomes after treatment of mild (abnormal milk) and moderate (abnormal milk and abnormal udder) cases of clinical mastitis (CM) occurring in a single quarter of cows on Wisconsin farms (n=4) and to determine risk factors associated with those outcomes. Duplicate milk samples were collected from the affected quarter of each cow for microbiological analysis at the onset of CM (PRE) and 21 d later (POST). Cows were treated only in the affected quarter using an intramammary product containing 125 mg of ceftiofur. Bacteriological cure was defined as absence of pathogens in the POST sample obtained from the enrolled quarter. Recurrence was defined for the cow when CM occurred after the milk-withholding period for the enrolled case of CM. Retention in the herd was defined when a cow was retained within the herd for the 60-d follow-up period. Somatic cell count reduction (SCCR) was defined at the cow level as somatic cell count (SCC) below 200,000 cells/mL at the Dairy Herd Improvement Association test day occurring between 21 to 55 d post-treatment. The effects of farm, days in milk, parity, severity, microbiological diagnosis at PRE, previous milk yield, previous SCC, previous occurrence of CM and treatment duration on selected post-treatment outcomes were assessed using Chi-squared analysis and logistic regression. Microbiological results at PRE were distributed as: Escherichia coli (n=14), Klebsiella spp. (n=11), Enterobacter spp. (n=8), Serratia spp. (n=7), other gram-negative species (n=3), Streptococcus spp. (n=25), coagulase-negative staphylococci (n=4); Staphylococcus aureus (n=1); Streptococcus agalactiae (n=1), other gram-positive species (n=9), and culture negative (n=60). Treated quarters were more likely to experience bacteriological cure when the cow experienced CM for the first time in the lactation and when no pathogen was recovered from PRE milk samples obtained from the enrolled quarter. Parity and

  5. 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.

  6. 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...

  7. 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.

  8. Heme Oxygenase-1 Gene Therapy Provides Cardioprotection Via Control of Post-Ischemic Inflammation: An Experimental Study in a Pre-Clinical Pig Model.

    Science.gov (United States)

    Hinkel, Rabea; Lange, Philipp; Petersen, Björn; Gottlieb, Elena; Ng, Judy King Man; Finger, Stefanie; Horstkotte, Jan; Lee, Seungmin; Thormann, Michael; Knorr, Maike; El-Aouni, Chiraz; Boekstegers, Peter; Reichart, Bruno; Wenzel, Philip; Niemann, Heiner; Kupatt, Christian

    2015-07-14

    Heme oxygenase-1 (HO-1) is an inducible stress-responsive enzyme converting heme to bilirubin, carbon monoxide, and free iron, which exerts anti-inflammatory and antiapoptotic effects. Although efficient cardioprotection after HO-1 overexpression has been reported in rodents, its role in attenuating post-ischemic inflammation is unclear. This study assessed the efficacy of recombinant adenoassociated virus (rAAV)-encoding human heme oxygenase-1 (hHO-1) in attenuating post-ischemic inflammation in a murine and a porcine ischemia/reperfusion model. Murine ischemia was induced by 45 min of left anterior descending occlusion, followed by 24 h of reperfusion and functional as well as fluorescent-activated cell sorting analysis. Porcine hearts were subjected to 60 min of ischemia and 24h of reperfusion before hemodynamic and histologic analyses were performed. Human microvascular endothelial cells transfected with hHO-1 displayed an attenuated interleukin-6 and intercellular adhesion molecule 1 expression, resulting in reduced monocytic THP-1 cell recruitment in vitro. In murine left anterior descending occlusion and reperfusion, the post-ischemic influx of CD45(+) leukocytes, Ly-6G(+) neutrophils, and Ly-6C(high) monocytes was further exacerbated in HO-1-deficient hearts and reversed by rAAV.hHO-1 treatment. Conversely, in our porcine model of ischemia, the post-ischemic influx of myeloperoxidase-positive neutrophils and CD14(+) monocytes was reduced by 49% and 87% after rAAV.hHO-1 transduction, similar to hHO-1 transgenic pigs. Functionally, rAAV.hHO-1 and hHO-1 transgenic left ventricles displayed a smaller loss of ejection fraction than control animals. Whereas HO-1 deficiency exacerbates post-ischemic cardiac inflammation in mice, hHO-1 gene therapy attenuates inflammation after ischemia and reperfusion in murine and porcine hearts. Regional hHO-1 gene therapy provides cardioprotection in a pre-clinical porcine ischemia/reperfusion model. Copyright © 2015 American

  9. 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

  10. Some insights for a relationship marketing model integrating SERVQUAL and customer loyalty in dental clinics

    OpenAIRE

    Vargas Perez, Ana Maria; Grijalvo Martin, Maria Mercedes; Mercado Idoeta, Carmelo

    2012-01-01

    The demand of new services, the emergence of new business models, insufficient innovation, underestimation of customer loyalty and reluctance to adopt new management are evidence of the deficiencies and the lack of research about the relations between patients and dental clinics. In this article we propose the structure of a model of Relationship Marketing (RM) in the dental clinic that integrates information from SERVQUAL, Customer Loyalty (CL) and activities of RM and combines the vision of...

  11. Comparative Study between Two Market Clearing Schemes in Wind Dominant Electricity Markets

    DEFF Research Database (Denmark)

    Farashbashi-Astaneh, Seyed-Mostafa; Hu, Weihao; Chen, Zhe

    2015-01-01

    High price volatility and excessive price reduction are introduced as two emerging problems in wind dominant electricity markets. In this study, an agent-based simulation methodology is employed to investigate the impact of two pricing mechanisms, uniform and pay-as-bid, on the mentioned problems....... According to the proposed agent-based approach, electricity market agents (here generation units) learn from their previous bidding experience to obtain maximum financial. A comparative study is then conducted to investigate the impact of mentioned pricing schemes on price volatility and average price level....... It is shown that these two pricing mechanisms cause different bidding behaviours for the generation units. This study suggests that this change in market agent behaviour, modifies the overall price volatility and system average price. The results indicate that a pay-as-bid pricing mechanism can alleviate...

  12. POWER for reproductive health: results from a social marketing campaign promoting female and male condoms.

    Science.gov (United States)

    Bull, Sheana S; Posner, Samuel F; Ortiz, Charlene; Beaty, Brenda; Benton, Kathryn; Lin, Lillian; Pals, Sherri L; Evans, Tom

    2008-07-01

    To evaluate effects of a 6-month social marketing campaign on awareness of, attitudes toward and use of female as well as male condoms for 15-25 year-old-women. Using a time-space sampling methodology, we conducted a cross-sectional survey of 3407 women at pre-campaign in 12 western U.S. neighborhoods on female and male condom awareness, attitudes, and use. Six of the 12 study neighborhoods were randomly selected to receive the POWER social marketing campaign designed to impact condom knowledge, attitudes, and use. The campaign was followed with another cross-sectional survey of 3,003 women in all 12 study neighborhoods on condom knowledge, attitudes, use and awareness of POWER materials. We compared pre-and post-campaign surveys to determine the efficacy of POWER and conducted post hoc analyses on post-campaign data to determine if exposure to POWER was related to higher levels of positive condom attitudes and norms and condom use. We found no differences between neighborhoods with and without the POWER campaign with regard to our primary outcomes. To diagnose reasons for this null effect, we examined outcomes post hoc examining the influence of POWER exposure. Post hoc analyses show some evidence that exposure to POWER was associated with condom use. In the context of the nested trial, this raises concerns that post test only evaluations are limited. Establishing the efficacy of a social marketing campaign is challenging. This group randomized trial showed a null effect. Social marketing campaigns may need to have more media channels and saturation before they can show behavioral effects. Using a nested design with randomization at the community level and probability sampling introduces rigor not commonly seen in evaluations of social marketing campaigns.

  13. Traumatic events, post-migration living difficulties and post-traumatic symptoms in first generation immigrants: a primary care study

    Directory of Open Access Journals (Sweden)

    Massimiliano Aragona

    2013-06-01

    Full Text Available OBJECTIVES: To study potentially traumatic events (PTE, post-traumatic stress disorder (PTSD, anxiety, depression, somatization and post-migration living difficulties (PMLD in primary care immigrants. DESIGN: Patients self-rated transculturally validated questionnaires. Those with and without PTSD were compared on all variables. The influence of the number of PTE and of PMLD on PTSD was measured. RESULTS: 391 patients completed the questionnaires. Prevalence of PTSD was 10.2%. PTE and PMLD were frequent in the whole sample but more common in PTSD subjects. Either the number of PTE and of PMLD significantly increased the likelihood to have a PTSD. CONCLUSIONS: PTE, PMLD, PTSD and related conditions (anxiety, depression and somatization are frequent among immigrants in primary care, and either PTE and PMLD significantly influence resulting psychopathology. The implications in clinical practice are discussed.

  14. 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

  15. Residential Mortgage Market in Economic and Social Development of Ukraine

    Directory of Open Access Journals (Sweden)

    Onysko Stefaniia M.

    2014-02-01

    Full Text Available The article studies tendencies of development of the residential mortgage market in Ukraine in the post-crisis period 2009 – 2012, identifies main tendencies of development of the Ukrainian mortgage market and conducts analysis of the level of mortgage interest rates. The article analyses the modern state of the mortgage market of Ukraine, dynamics of volumes of mortgage loans, their cost, structure of banks as mortgage creditors and cost of housing in Ukraine in the studied period. The article makes a number of offers on efficiency of mortgage, offers directions of financial support of rehabilitation of the market for solving housing problems of the population and identifies importance of state support of mortgage development.

  16. [Post-gastrectomy reconstruction versus enteral alimentation--a one year follow-up study].

    Science.gov (United States)

    Kostov, D; Balabanova, G; Vasilev, B; Plachkov, I; Ignatov, G

    2000-01-01

    This is a report on various post-gastrectomy reconstructive procedures, proceeding from personal experience had with 14 patients undergoing gastrectomy for carcinoma of the stomach and five patients with operations of esophagus and stomach for various pathological conditions. An assessment is done of the reconstructive methods used on the ground of objective indicators. All patients are subjected to enteral alimentation through nutritive jejunostomy. In the pre- and postoperatived periods, the trophic state of patients is evaluated on basis of biochemical, anthropometric and immunologic study data. Postoperatively, in those with small-intestinal reservoir a lower degree negative symptomatology is established, along with life style improvement. Post-gastrectomy patients presenting I-II (UICC) stage of the oncological disease are indicated for small-intestinal reservoir formation. In the overall therapeutic approach to post-gastrectomy patients adequate clinical therapeutic feeding proves absolutely indispensable.

  17. Economic Segmentation and Health Inequalities in Urban Post-Reform China.

    Science.gov (United States)

    Kwon, Soyoung

    2016-01-01

    During economic reform, Chinese economic labor markets became segmented by state sector associated with a planned redistributive economy and private sector associated with the market economy. By considering an economic sector as a concrete institutional setting in post-reform China, this paper compares the extent to which socioeconomic status, measured by education and income, is associated with self-rated health between state sector and private sector. The sample is limited to urban Chinese employees between the ages of 18 and 55 who were active in the labor force. By analyzing pooled data from the 1991-2006 Chinese Health and Nutrition Survey , I find that there is a stronger association between income and self-rated health in the private sector than in the state sector. This study suggests that sectoral differences between market and redistributive economies are an important key to understanding health inequalities in post-reform urban China.

  18. Post graduate clinical placements: evaluating benefits and challenges with a mixed methods cross sectional design.

    Science.gov (United States)

    Yiend, Jenny; Tracy, Derek K; Sreenan, Brian; Cardi, Valentina; Foulkes, Tina; Koutsantoni, Katerina; Kravariti, Eugenia; Tchanturia, Kate; Willmott, Lucy; Shergill, Sukhi; Reedy, Gabriel

    2016-02-16

    Systematic evaluations of clinical placements are rare, especially when offered alongside academic postgraduate courses. An evidence-based approach is important to allow pedagogically-driven provision, rather than that solely governed by opinion or market demand. Our evaluation assessed a voluntary clinical placement scheme allied to a mental health course. Data were collected over academic years 2010/11- 2013/14, from participating students (n = 20 to 58) and clinician supervisors (n = 10-12), using a mixed-methods cross-sectional design. Quantitative evaluation captured information on uptake, dropout, resource use, attitudes and experience, using standardized (the Placement Evaluation Questionnaire; the Scale To Assess the Therapeutic Relationship - Clinical version and the University of Toronto Placement Supervisor Evaluation) and bespoke questionnaires and audit data. Qualitative evaluation comprised two focus groups (5 clinicians, 5 students), to investigate attitudes, experience, perceived benefits, disadvantages and desired future developments. Data were analysed using framework analysis to identify a priori and emergent themes. High uptake (around 70 placements per annum), low dropout (2-3 students per annum; 5 %) and positive focus group comments suggested placements successfully provided added value and catered sufficiently to student demand. Students' responses confirmed that placements met expectations and the perception of benefit remained after completion with 70 % (n = 14) reporting an overall positive experience, 75 % (n = 15) reporting a pleasant learning experience, 60 % (n = 12) feeling that their clinical skills were enhanced and 85 % (n = 17) believing that it would benefit other students. Placements contributed the equivalent of seven full time unskilled posts per annum to local health care services. While qualitative data revealed perceived 'mutual benefit' for both students and clinicians, this was qualified by

  19. Canadian retail petroleum markets study : a review of competitiveness in the Canadian refined petroleum marketing industry

    International Nuclear Information System (INIS)

    Ervin, M.J.

    1997-01-01

    A retail petroleum market study was conducted to provide a comprehensive overview of the competitiveness of the downstream petroleum industry in Canada, as well as to provide a foundation for effective policy development. A model which illustrates the interrelationships between the many stakeholders who receive revenue from the sale of gasoline was presented. It was shown that although there has been an upward trend in world crude prices since 1991, both refiners and marketers have experienced a decline in margins due to price competition at the rack and at the retail pump. Government intervention into petroleum marketing was considered to be of questionable value and a poor alternative to market-based regulation. In this study, 19 markets representing a broad range of conditions, were chosen for a detailed review of outlet economics. Market-by-market and regional comparisons of key competitiveness indicators were reviewed and discussed. Improving public understanding and awareness of competition in the petroleum marketing sector and developing cooperative industry research into marketing sector competitive issues were recommended. 7 refs., 15 tabs., 37 figs

  20. Conducting clinical trials in emerging markets of sub-Saharan Africa: review of guidelines and resources for foreign sponsors

    Directory of Open Access Journals (Sweden)

    Puppalwar G

    2015-03-01

    Full Text Available Gaurav Puppalwar, Meenakshi Mourya, Ganesh Kadhe, Amey Mane Medical Affairs, Wockhardt Limited, Wockhardt Towers, Bandra Kurla Complex, Mumbai, India Abstract: Clinical trials provide a foundation for new drug development processes, as well as for product license extensions for existing therapies. The reduction in the amount of time and cost to conduct a clinical trial becomes important, as competition to bring a new drug to the market is increasing, and so is the search for new markets. Kenya, Nigeria, Tanzania, Uganda, and Zambia offer a diverse patient population, as well as a comparatively research-friendly and ambitious government to develop these countries as pharmaceutical and health sectors of excellence. All these countries have their own guidelines to conduct clinical trials that feature some similarities and some subtle differences. Over the last decade, the guidelines have been evolving to provide a good ground to foreign sponsors, which carry out clinical trials while keeping the interest of patients as a priority. In the advent of these evolving guidelines, it becomes important for a foreign sponsor to understand and be aware of these guidelines before carrying out clinical trials. The present paper attempts to collect and compile all information available regarding the guidelines on the conduct of trials by a foreign sponsor in these five countries, which are available at government websites and search engines. The information gathered was organized into simplified flowcharts for easy understanding and usage. A clear understanding of the guidelines can effectively reduce the challenges faced for conducting clinical trials in these countries. Keywords: informed consent, ethics, drug development, emerging markets

  1. A complementarity model for the European natural gas market

    International Nuclear Information System (INIS)

    Egging, Ruud; Gabriel, Steven A.; Holz, Franziska; Zhuang, Jifang

    2008-01-01

    In this paper, we present a detailed and comprehensive complementarity model for computing market equilibrium values in the European natural gas system. Market players include producers and their marketing arms which we call 'traders', pipeline and storage operators, marketers, LNG liquefiers, regasifiers, tankers, and three end-use consumption sectors. The economic behavior of producers, traders, pipeline and storage operators, liquefiers and regasifiers is modeled via optimization problems whose Karush-Kuhn-Tucker (KKT) optimality conditions in combination with market-clearing conditions form the complementarity system. The LNG tankers, marketers and consumption sectors are modeled implicitly via appropriate cost functions, aggregate demand curves, and ex post calculations, respectively. The model is run on several case studies that highlight its capabilities, including a simulation of a disruption of Russian supplies via Ukraine

  2. Marketing trials, marketing tricks - how to spot them and how to stop them.

    Science.gov (United States)

    Matheson, Alastair

    2017-03-08

    Last this year in this journal, Barbour and colleagues reported a study of "marketing trials" in leading medical journals (Trials 2016;17:31). In this commentary I discuss their research, describe new analyses of the study cohort and consider measures to address marketing within academic medical literature. Barbour et al. sought to identify a subgroup of "marketing trials" within leading medical journals, but in reality, nearly all industry-financed trials serve marketing functions, and many exhibit marketing-related features, including biases, in their framing, methodology or reporting. I conducted new analyses of the cohort of Barbour et al., showing that most trials funded exclusively by drug manufacturers had direct involvement of the manufacturer in design, analysis and reporting, and features supportive of product seeding. However, these commercial enterprises were without exception presented to journal readers as academic-led projects, using attributional spin, which should itself be considered an important form of marketing bias. Barbour et al. correctly conclude that commercial bias in industry clinical trials articles often requires expertise to recognize, and in many cases cannot be identified from the published journal report. Several potential remedies are discussed, including independent clinical research, data sharing, improved reporting guidance, improved tools for assessing research quality, reforms to article attribution, submission checklists and new editorial standards. Medicine's journals have a responsibility to uphold rigorous scientific and reporting standards, require ready trials data access and ensure the commercial dimensions of research are brought prominently to their readers' attention. Failure to meet these responsibilities constitutes an enduring threat to the integrity of biomedical literature.

  3. Factors of Attracting Customers in the Jordanian Consumer Markets: A Case Study of Amman Markets

    Directory of Open Access Journals (Sweden)

    Hisham Ali SHATNAWI

    2016-09-01

    Full Text Available This study aims to identify the influential factors of shopping patterns in commercial markets. The study was carried out on a random sample consisting of 249 consumers in the city of Amman. The study also used a questionnaire as an essential tool to collect data for the study population; also it used scientific research in the field of commercial markets and consumer behaviors in collecting secondary data. After conducting a statistically significant analysis, the study showed the following results: the study sample is affected by the quality of provided services and how much these services exhibit convenience and appropriate use. Also, the promotional policies such as advertising, samples, gifts and withdraw on goods and much more can attract customers towards these markets. Moreover, the study found that psychological factors and consumes’ patterns of purchasing have a direct impact on their choices of commercial markets.

  4. Current challenges for clinical trials of cardiovascular medical devices.

    Science.gov (United States)

    Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

    2014-07-15

    Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  5. Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

    Science.gov (United States)

    Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

    2016-01-28

    Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome

  6. Clinical utility of PPPM and FPS-R to quantify post-tonsillectomy pain in children.

    Science.gov (United States)

    de Azevedo, Carolina Brotto; Carenzi, Lucas Rodrigues; de Queiroz, Danielle Leite Cunha; Anselmo-Lima, Wilma T; Valera, Fabiana Cardoso Pereira; Tamashiro, Edwin

    2014-02-01

    As pain is a subjective and difficult parameter to assess in children, we aimed to evaluate the correspondence of two pain scales - parents' post-operative pain measure (PPPM) and faces pain scale-revised (FPS-R) with analgesic intake in the assessment of post-tonsillectomy pain in a pediatric population. Children aged 4-10 years (n=174) undergoing tonsillectomy with or without adenoidectomy had their pain monitored by PPPM and FPS-R over 7 days following surgery. The amount of analgesic (acetaminophen or dipyrone) intake was also recorded each day. Linear regression and correlation analysis were performed for pain scales and Poisson regression model for analgesic administration. To evaluate influence of gender linear regression and logistic regression with random effects were performed. PPPM and FPS-R presented a significant positive correlation (τ=0.5; R(2)=0.36; pFPS-R also showed a significant correlation with analgesic use over the 7 post-operative days (pFPS-R are equivalent pain scales to quantify post-tonsillectomy pain in children and are useful tools in post-tonsillectomy clinical research. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  7. The effect of marketing innovation, market orientation, and social capital on competitive advantage and marketing performance: A study in MSMEs of embroidery Central Java Province

    OpenAIRE

    Ag. Sunarno Handoyo

    2015-01-01

    This study deals with marketing innovation, market orientation, and social capital in affecting the competitive advantage and marketing performance in Micro, Small, and Medium Enterprises (MSMEs) of embroidery in Central Java Province. In this respect, this study tried to test and analyze the effect of marketing innovation, market orienta-tion, and social capital on competitive advantage and marketing performance in Micro, Small, and Medium Enterprises (MSMEs) of embroidery in Central Java Pr...

  8. Natural gas market assessment: Price convergence in North American natural gas markets

    International Nuclear Information System (INIS)

    1995-12-01

    The extent to which Canadian and U.S. natural gas markets have become integrated in the post-deregulation era was assessed. This assessment was accomplished through a statistical analysis of the price movements in Canadian and U.S. gas markets. The analysis pointed to three broad conclusions: (1) on the whole, there has been an increasing degree of integration among North American natural gas markets since price deregulation and the introduction of open access, (2) there is somewhat of a split between eastern and western markets, (3) Alberta's links are stronger with the western U.S. natural gas market than with the market in the eastern U.S. Several factors were cited as contributing to the general increase in market integration, including: (1) increased pipeline capacity and additional pipeline interconnections, coupled with the development of market hubs, (2) improved flexibility of access to pipeline transportation services, (3) improved access to market information and greater trading flexibility which has been facilitated by growing use of electronic bulletin boards and electronic trading systems. The increased market integration was claimed to have benefited both consumers and producers, and to have increased competition in both countries.. 28 refs., 14 figs

  9. Clinical significance of atypical squamous cells of undetermined significance in detecting preinvasive cervical lesions in post- menopausal Turkish women.

    Science.gov (United States)

    Tokmak, Aytekin; Guzel, Ali Irfan; Ozgu, Emre; Oz, Murat; Akbay, Serap; Erkaya, Salim; Gungor, Tayfun

    2014-01-01

    To evaluate the clinical significance of atypical squamous cells of undetermined significance (ASCUS) in PAP test in post-menopausal women and compare with reproductive age women. A total of 367 patients who referred to our gynecologic oncology clinic were included to the study between September 2012 and August 2013. Data for 164 post-menopausal (group 1) and 203 pre-menopausal (group 2) women with ASCUS cytology were evaluated retrospectively. Immediate colposcopy and endocervical curettage was performed for both groups and conization for all women with a result suggestive of CIN2-3. Histopathological results and demographic features of patients were compared between the two groups. Mean age of the patients was 54.6±6.5 years in group 1 and 38±6.6 years in group 2. Some 14 (8.5%) of post- menopausal women and 36 (17.7%) of pre-menopausal women were current smokers (p=011). Totals of 38 (23.2%) post-menopausal and 64 (31.5%) pre-menopausal women were assessed for HPV-DNA. High risk HPV was detected in 7 (4.3%) and 21 (10.3%), respectively (p=0.029). Final histopathological results recorded were normal cervix, low grade cervical intra-epithelial neoplasia (CIN 1), and high grade cervical intra-epithelial neoplasia (CIN2-3). In group 1 results were 84.8%, 12.2% and 1.8%, respectively, and in group 2 were 71.9%, 23.2% and 4.9%. There were no cases of micro invasive or invasive cervical carcinoma in either group. Two cases were detected as endometrial carcinoma in the menopausal group (1.2%). In current study we found that preinvasive lesions were statistically significantly higher in pre-menopausal women than post- menopausal women with ASCUS. Cervicitis was more common in menopausal women. Therefore, we think that in case of ASCUS in a post-menopausal woman there is no need for radical management.

  10. Social media marketing : Acquiring customer loyalty and relationship management using social media as a marketing channel

    OpenAIRE

    Saqib, Muhammad

    2016-01-01

    Abstract Social media is a marketing phenomenon that is growing very fast. Social media helps creating value for customers in broadcasting the advertising among social networks. Blog posts, videos, pictures, reviews and ratings all have a significant impact on marketing. The purpose of the thesis is to investigate how companies can achieve customer loyalty and customer relationship management using social media marketing and if companies can target new customers by social media. An inductive ...

  11. An Essay on Marketing Performance Assessment: Opportunities in the Context of Research Studies in Marketing in Brazil

    Directory of Open Access Journals (Sweden)

    Leandro Angotti Guissoni

    2013-12-01

    Full Text Available Assessing marketing performance is important in order to minimize the subjectivism in the decision making process. Assessing marketing performance is an alternative so marketing will no longer be considered as a tactical area but rather strategically. In this context, research in marketing should investigate the effects of marketing activities by applying metrics. Despite marketing’s growing importance in journals and developed markets, there are few research studies in Brazil, so we organized a theoretical essay. This essay intends to contribute to the marketing literature in two ways: i by presenting a detailed overview of the marketing performance literature from the 1960’s until the year 2012, which allows us to complement previous studies, from a new perspective on the evolution of the central ideas in marketing; ii identifying research opportunities related to this topic that may stimulate debates and future research. 

  12. World helicopter market study

    Science.gov (United States)

    Cleary, B.; Pearson, R. W.; Greenwood, S. W.; Kaplan, L.

    1978-01-01

    The extent of the threat to the US helicopter industry posed by a determined effort by foreign manufacturers, European companies in particular, to supply their own domestic markets and also to penetrate export markets, including the USA is assessed. Available data on US and world markets for civil and military uses are collated and presented in both graphic and tabular form showing the past history of production and markets and, where forecasts are available, anticipated future trends. The data are discussed on an item-by-item basis and inferences are drawn in as much depth as appears justified.

  13. Post-Digital Literary Studies

    Directory of Open Access Journals (Sweden)

    Florian Cramer

    2016-03-01

    Full Text Available Digital humanities and digital literary studies face much the same challenges as contemporary media art: what will become of them once their media are no longer “new”, and the limitations of processing art as data have become more clearly and widely understood? This paper revisits information aesthetics and computer poetics from the 1960s and 1970s, casting them as precursors of today’s digital humanities, with many of the same issues, achievements and failures, and with their own hype cycles of boom and bust. Conversely, “post-digital” and “Post-Internet” trends in music, graphic design and visual arts may anticipate possible futures of digital humanities and literary studies after the hype has passed.

  14. Adoption Space and the Idea-to-Market Process of Health Technologies.

    Science.gov (United States)

    Saranummi, Niilo; Beuscart, Regis; Black, Norman; Maglaveras, Nicos; Strano, Chiara; Karavidopoulou, Youla

    2016-01-01

    Although Europe 'produces' excellent science, it has not been equally successful in translating scientific results into commercially successful companies in spite of European and national efforts invested in supporting the translation process. The Idea-to-Market process is highly complex due to the large number of actors and stakeholders. ITECH was launched to propose recommendations which would accelerate the Idea-to-Market process of health technologies leading to improvements in the competitiveness of the European health technology industry in the global markets. The project went through the following steps: defining the Idea-to-Market process model; collection and analysis of funding opportunities; identification of 12 gaps and barriers in the Idea-to-Market process; a detailed analysis of these supported by interviews; a prioritization process to select the most important issues; construction of roadmaps for the prioritized issues; and finally generating recommendations and associated action plans. Seven issues were classified as in need of actions. Three of these are part of the ongoing Medical Device Directive Reform (MDR), namely health technology assessment, post-market surveillance and regulatory process, and therefore not within the scope of ITECH. Recommendations were made for eHealth taxonomy; Education and training; Clinical trials and Adoption space and Human Factors Engineering (HFE).

  15. Does an Environmental Marketing Strategy Influence Marketing and Financial Performance? A Study of Indonesian Exporting Firms

    Directory of Open Access Journals (Sweden)

    Kardison Lumban Batu

    2017-01-01

    Full Text Available Purpose – Broadly speaking, the implementation of green practice leads to higher performance in exporting firms. To test this concept empirically, this study proposes environmental marketing strategy as an antecedent of product differentiation and cost leadership as a means to promote marketing and financial performance. Design/Methodology/Approach – This study was conducted on 388 respondents serving as operational, production, and marketing managers of Indonesian exporting firms and used structural equation modelling (SEM with AMOS 18 as an analysis technique. Findings and implications – The findings revealed that environmental marketing strategy significantly influences product differentiation and cost leadership. More specifically, product differentiation simultaneously influences marketing and financial performance. However, cost leadership influences financial performance but not marketing performance. This study implies the importance of environmental orientation in setting a firm strategy and promoting the performance of international firms. Limitations – The measurement items proposed in this study were adopted from studies conducted in developed countries; they have not been proven appropriate for direct application in developing countries such as Indonesia. Originality – This study is original in that it explores the importance of environmental studies in setting a firm strategy and promoting the performance of international business.

  16. 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

  17. A clinical-molecular prognostic model to predict survival in patients with post polycythemia vera and post essential thrombocythemia myelofibrosis.

    Science.gov (United States)

    Passamonti, F; Giorgino, T; Mora, B; Guglielmelli, P; Rumi, E; Maffioli, M; Rambaldi, A; Caramella, M; Komrokji, R; Gotlib, J; Kiladjian, J J; Cervantes, F; Devos, T; Palandri, F; De Stefano, V; Ruggeri, M; Silver, R T; Benevolo, G; Albano, F; Caramazza, D; Merli, M; Pietra, D; Casalone, R; Rotunno, G; Barbui, T; Cazzola, M; Vannucchi, A M

    2017-12-01

    Polycythemia vera (PV) and essential thrombocythemia (ET) are myeloproliferative neoplasms with variable risk of evolution into post-PV and post-ET myelofibrosis, from now on referred to as secondary myelofibrosis (SMF). No specific tools have been defined for risk stratification in SMF. To develop a prognostic model for predicting survival, we studied 685 JAK2, CALR, and MPL annotated patients with SMF. Median survival of the whole cohort was 9.3 years (95% CI: 8-not reached-NR-). Through penalized Cox regressions we identified negative predictors of survival and according to beta risk coefficients we assigned 2 points to hemoglobin level <11 g/dl, to circulating blasts ⩾3%, and to CALR-unmutated genotype, 1 point to platelet count <150 × 10 9 /l and to constitutional symptoms, and 0.15 points to any year of age. Myelofibrosis Secondary to PV and ET-Prognostic Model (MYSEC-PM) allocated SMF patients into four risk categories with different survival (P<0.0001): low (median survival NR; 133 patients), intermediate-1 (9.3 years, 95% CI: 8.1-NR; 245 patients), intermediate-2 (4.4 years, 95% CI: 3.2-7.9; 126 patients), and high risk (2 years, 95% CI: 1.7-3.9; 75 patients). Finally, we found that the MYSEC-PM represents the most appropriate tool for SMF decision-making to be used in clinical and trial settings.

  18. Study on electricity markets in Romania

    Directory of Open Access Journals (Sweden)

    Alexandra FLOREA

    2017-03-01

    Full Text Available In this paper, we detail about the components of the wholesale electricity market in Romania: Market for Bilateral Contracts (Central Market with continuous double negotiation of bilateral electric energy contracts (CM - OTC, Centralized Market for bilateral electric energy contracts, Day-Ahead Market (DAM, Inter-Daily Market (IM, Balancing Market (BM, Centralized Market for universal service (CMUS. In addition, for each type of market we generated diagrams with the main business processes.

  19. Ahmed glaucoma valve in post-penetrating-keratoplasty glaucoma: A critically evaluated prospective clinical study

    Directory of Open Access Journals (Sweden)

    Anita Panda

    2011-01-01

    Full Text Available Aim: The aim was to evaluate the outcome of Ahmed glaucoma valve (AGV in post-penetrating-keratoplasty glaucoma (PKPG. Materials and Methods: In this prospective study, 20 eyes of 20 adult patients with post-PKPG with intraocular pressure (IOP >21 mmHg, on two or more antiglaucoma medications, underwent AG (model FP7 implantation and were followed up for a minimum of 6 months. Absolute success was defined as 5 < IOP < 21 mmHg and qualified success as 5 < IOP < 21 mmHg with medications or minor procedures. Results: The mean IOP decreased from 42.95 ± 10.24 to 17.69 ± 3.64 mmHg (P < 0.001 and the use of medications dropped from 2.92 to 0.39 (P < 0.001 after AGV implantation. The absolute success was achieved in 11 eyes and qualified success in 9. There was no significant change in best corrected visual acuity, graft clarity, or graft thickness. Six device-related complications occurred after AGV implantations which were successfully managed with medical or minor surgical therapy. Conclusions: Postkeratoplasty refractory glaucoma managed by AGV implantation revealed a satisfactory outcome up to 6 months of follow-up.

  20. Economic Segmentation and Health Inequalities in Urban Post-Reform China

    Directory of Open Access Journals (Sweden)

    Soyoung Kwon

    2016-08-01

    Full Text Available During economic reform, Chinese economic labor markets became segmented by state sector associated with a planned redistributive economy and private sector associated with the market economy. By considering an economic sector as a concrete institutional setting in post-reform China, this paper compares the extent to which socioeconomic status, measured by education and income, is associated with self-rated health between state sector and private sector. The sample is limited to urban Chinese employees between the ages of 18 and 55 who were active in the labor force. By analyzing pooled data from the 1991–2006 Chinese Health and Nutrition Survey, I find that there is a stronger association between income and self-rated health in the private sector than in the state sector. This study suggests that sectoral differences between market and redistributive economies are an important key to understanding health inequalities in post-reform urban China.

  1. Quantitative Analysis of the Adapted Physical Education Employment Market in Higher Education

    Science.gov (United States)

    Zhang, Jiabei

    2010-01-01

    The purpose of this study was to analyze the employment market of adapted physical education (APE) careers in higher education since 1975 to see if the increase of this market has continued since 1998. Based on the data collected from the "Chronicle of Higher Education", a total of 887 APE job openings have been posted since 1975,…

  2. Knowledge and Skill Requirements for Marketing Jobs in the 21st Century

    Science.gov (United States)

    Schlee, Regina Pefanis; Harich, Katrin R.

    2010-01-01

    This study examines the skills and conceptual knowledge that employers require for marketing positions at different levels ranging from entry- or lower-level jobs to middle- and senior-level positions. The data for this research are based on a content analysis of 500 marketing jobs posted on Monster.com for Atlanta, Chicago, Los Angeles, New York…

  3. Affiliate marketing programs: A study of consumer attitude towards affiliate marketing programs among Indian users

    OpenAIRE

    Zia Ul Haq

    2012-01-01

    Affiliate marketing has seen fewer studies even being a multibillion dollar industry and one of the most expanding online advertising lead generators for direct marketers. The aim of this survey described in this paper is to evaluate the attitude of respondents towards affiliate programs or affiliate marketing, used as a source of information, advertisement and a connecting link between the online marketer and the customer. In this regard a survey was conducted among 300 Indian internet users...

  4. 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.

  5. 78 FR 79436 - Boulder Canyon Project-Post-2017 Resource Pool

    Science.gov (United States)

    2013-12-30

    ... customers of electric utilities. The marketing criteria should include municipal corporations and political... Pool AGENCY: Western Area Power Administration, DOE. ACTION: Notice of final marketing criteria and... marketing agency of the Department of Energy (DOE), announces the Boulder Canyon Project (BCP) post-2017...

  6. Exploiting science? A systematic analysis of complementary and alternative medicine clinic websites' marketing of stem cell therapies.

    Science.gov (United States)

    Murdoch, Blake; Zarzeczny, Amy; Caulfield, Timothy

    2018-02-28

    To identify the frequency and qualitative characteristics of stem cell-related marketing claims made on websites of clinics featuring common types of complementary and alternative medicine practitioners. The involvement of complementary and alternative medicine practitioners in the marketing of stem cell therapies and stem cell-related interventions is understudied. This research explores the extent to which they are involved and collaborate with medical professionals. This knowledge will help with identifying and evaluating potential policy responses to this growing market. Systematic website analysis. Global. US and English-language bias due to methodology. Representations made on clinic websites in relation to practitioner types, stem cell therapies and their targets, stem cell-related interventions. Statements about stem cell therapies relating to evidence of inefficacy, limited evidence of efficacy, general procedural risks, risks specific to the mode of therapy, regulatory status, experimental or unproven nature of therapy. Use of hype language (eg, language that exaggerates potential benefits). 243 websites offered stem cell therapies. Many websites advertised stem cell transplantation from multiple sources, such as adipose-derived (112), bone marrow-derived (100), blood-derived (28), umbilical cord-derived (26) and others. Plant stem cell-based treatments and products (20) were also advertised. Purposes for and targets of treatment included pain, physical injury, a wide range of diseases and illnesses, cosmetic concerns, non-cosmetic ageing, sexual enhancement and others. Medical doctors (130), chiropractors (53) and naturopaths (44) commonly work in the clinics we found to be offering stem cell therapies. Few clinic websites advertising stem cell therapies included important additional information, including statements about evidence of inefficacy (present on only 12.76% of websites), statements about limited evidence of efficacy (18.93%), statements of

  7. THE IMPORTANCE OF DIGITAL MARKETING. AN EXPLORATORY STUDY TO FIND THE PERCEPTION AND EFFECTIVENESS OF DIGITAL MARKETING AMONGST THE MARKETING PROFESSIONALS IN PAKISTAN

    OpenAIRE

    Fawad Khan; Kamran Siddiqui

    2013-01-01

    The purpose of this exploratory research is to present the perceptions towards Digital Marketing in Pakistan. This issue has rarely been addressed by the academicians and researchers in Pakistan and elsewhere. This study used digital marketing parameters to measure the awareness and effectiveness of digital marketing among marketing professionals in Pakistan. 200 marketing professionals participated in this academic exercise. Data was analyzed in many ways, a) through descriptive statistics b...

  8. Information transmission and market interactions across the Atlantic. An empirical study on the natural gas market

    International Nuclear Information System (INIS)

    Kao, Chung-Wei; Wan, Jer-Yuh

    2009-01-01

    This paper studies the international information transmission and market interactions in the U.S. and U.K. natural gas markets. Three well documented approaches are used to measure the relative importance on the process of price discovery under a quadvariate system. After adjusting the effects of nonsynchronous trading prices, robust results indicate our system that includes spot and futures prices within the two countries are driven by one common factor. Information disseminates efficiently among the four markets concerned. The U.S. futures market dominates as the center for price discovery. The U.K. futures market comes as the second. The spot markets in the U.S. and U.K. are less efficient than their corresponding futures market, where the U.K. spot market contributes the least and almost zero to the price discovery process. Asymmetric volatility spillovers are found in three of the four markets. Volatility in the U.S. futures market increases with positive returns which illustrates the inverse leverage effect in most of the commodity market. Volatilities in the spot markets are negatively related to returns, which is analogous to the traditional leverage effect prevailing in most of the equity stock markets. (author)

  9. Realistic electricity market simulator for energy and economic studies

    International Nuclear Information System (INIS)

    Bernal-Agustin, Jose L.; Contreras, Javier; Conejo, Antonio J.; Martin-Flores, Raul

    2007-01-01

    Electricity market simulators have become a useful tool to train engineers in the power industry. With the maturing of electricity markets throughout the world, there is a need for sophisticated software tools that can replicate the actual behavior of power markets. In most of these markets, power producers/consumers submit production/demand bids and the Market Operator clears the market producing a single price per hour. What makes markets different from each other are the bidding rules and the clearing algorithms to balance the market. This paper presents a realistic simulator of the day-ahead electricity market of mainland Spain. All the rules that govern this market are modeled. This simulator can be used either to train employees by power companies or to teach electricity markets courses in universities. To illustrate the tool, several realistic case studies are presented and discussed. (author)

  10. MARKETING SYSTEM OF MARINE FISH IN BANGLADESH: AN EMPIRICAL STUDY

    OpenAIRE

    Islam, M. Serajul; Miah, Tofazzal Hossain; Haque, Md. Mojammel

    2000-01-01

    This paper was designed to investigate the present status of marine fish marketing aiming to determine marketing costs, margins and profits of marketing intermediaries both in domestic and export marketing. Primary data were collected by survey method wherein various market intermediaries were interviewed from selected districts for eliciting information at various stages of marine fish marketing. The study revealed that marketing margin as well as marketing profit both were relatively higher...

  11. 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

  12. A global assessment of market accessibility and market influence for global environmental change studies

    NARCIS (Netherlands)

    Verburg, P.H.; Ellis, E.C.; Letourneau, A.

    2011-01-01

    Markets influence the global patterns of urbanization, deforestation, agriculture and other land use systems. Yet market influence is rarely incorporated into spatially explicit global studies of environmental change, largely because consistent global data are lacking below the national level. Here

  13. 99mTc-DTPA aerosol for same-day post-perfusion ventilation imaging: Results of a multicentre study

    International Nuclear Information System (INIS)

    Koehn, H.; Koenig, B.; Bachmayr, S.; Markt, B.; Eber, O.; Lind, P.; Galvan, G.; Rettenbacher, L.; Holm, C.; Ogris, E.

    1993-01-01

    A multicentre study was performed in an attempt to evaluate a submicronic technetium-99m diethylene triamine penta-acetic acid aerosol generated by a newly developed delivery system, the aerosol production equipment (APE nebulizer), for same-day post-perfusion ventilation imaging in patients with clinically suspected pulmonary embolism. Quantitative comparison between the DTPA aerosol and krypton gas demonstrated a close correlation with respect to regional pulmonary distribution of activity and peripheral lung penetration (n=14, r=0.94, P 99m Tc-labelled DTPA aerosol is well suited for fast same-day post-perfusion ventilation imaging in patients with clinical suspicion of pulmonary embolism. (orig.)

  14. A study on the effects of marketing communication using integrated marketing communication

    OpenAIRE

    Solmaz Sellahvarzi; Vahid Reza Mirabi; Mehdi Iran Nejad Parizi

    2014-01-01

    Integrated Marketing Communication (IMC) is one of the needed concepts in competitive edge. IMC is defined as a cross functional process for creating and nourishing profitable relationships with customers and other stakeholders by strategically controlling or impacting all messages sent to these groups. It ensures that all forms of communications and messages are carefully linked together. This study investigates the effectiveness of marketing communication in an Iranian automaker named Khodr...

  15. 76 FR 81487 - Application of the Energy Planning and Management Program Power Marketing Initiative to the...

    Science.gov (United States)

    2011-12-28

    ... Management Program Power Marketing Initiative to the Boulder Canyon Project Post-2017 Remarketing AGENCY... . Information regarding Western's BCP Post-2017 marketing efforts, the Energy Management and Planning Program... Proposals. SUMMARY: The Western Area Power Administration (Western), a Federal power marketing agency of the...

  16. Differential Fecundity, Markets and Gender Roles

    OpenAIRE

    Aloysius Siow

    1996-01-01

    Women are fecund for a shorter period of their lives than men. This paper investigates how differential fecundity interacts with marriage, labor and financial markets to affect gender roles. The main findings of the paper are: (i) Differential fecundity does not have any market invariant gender effect. (ii) Gender roles depend on competition for mates in the marriage market and the way in which ex-post differences in earnings affect that competition. (iii) Gender differences in the labor mark...

  17. Farmers' Markets in Rural Communities: A Case Study

    Science.gov (United States)

    Alfonso, Moya L.; Nickelson, Jen; Cohen, Danielle

    2012-01-01

    Background: Although the potential health benefits of farmers markets have been discussed for years, there is a dearth of literature to aid health educators in advocating for the development of local farmers markets. Purpose: The purpose of this manuscript is to present a case study of a rural farmers market in southeast Georgia with emphasis on…

  18. Clinical Age-Specific Seasonal Conjunctivitis Patterns and Their Online Detection in Twitter, Blog, Forum, and Comment Social Media Posts

    Science.gov (United States)

    Deiner, Michael S.; McLeod, Stephen D.; Chodosh, James; Oldenburg, Catherine E.; Fathy, Cherie A.; Lietman, Thomas M.; Porco, Travis C.

    2018-01-01

    Purpose We sought to determine whether big data from social media might reveal seasonal trends of conjunctivitis, most forms of which are nonreportable. Methods Social media posts (from Twitter, and from online forums and blogs) were classified by age and by conjunctivitis type (allergic or infectious) using Boolean and machine learning methods. Based on spline smoothing, we estimated the circular mean occurrence time (a measure of central tendency for occurrence) and the circular variance (a measure of uniformity of occurrence throughout the year, providing an index of seasonality). Clinical records from a large tertiary care provider were analyzed in a similar way for comparison. Results Social media posts machine-coded as being related to infectious conjunctivitis showed similar times of occurrence and degree of seasonality to clinical infectious cases, and likewise for machine-coded allergic conjunctivitis posts compared to clinical allergic cases. Allergic conjunctivitis showed a distinctively different seasonal pattern than infectious conjunctivitis, with a mean occurrence time later in the spring. Infectious conjunctivitis for children showed markedly greater seasonality than for adults, though the occurrence times were similar; no such difference for allergic conjunctivitis was seen. Conclusions Social media posts broadly track the seasonal occurrence of allergic and infectious conjunctivitis, and may be a useful supplement for epidemiologic monitoring. PMID:29450538

  19. Marketing-Stimulated Word-of-Mouth: A Channel for Growing Demand.

    Science.gov (United States)

    Gombeski, William R; Martin, Becky; Britt, Jason

    2015-01-01

    Marketing-stimulated word-of-mouth (WOM) marketing has been poorly understood in health care, leading to it being underappreciated and underutilized by marketers. A study of new patients to a new runner's clinic was conducted to understand how they chose the program. The importance of marketing-stimulated WOM, both individual and organizational, is documented. Marketing-stimulated WOM is an often overlooked and rarely measured channel for increasing the impact of marketing programs.

  20. Role of WhatsApp-based discussions in improving residents' knowledge of post-operative pain management: a pilot study.

    Science.gov (United States)

    Bakshi, Sumitra G; Bhawalkar, Pranay

    2017-10-01

    To provide a platform for the dissemination of basic knowledge of pain management, a WhatsApp group was created by residents and consultants. Common clinical scenarios, resident queries, and important instructions to be followed by residents with respect to running the Acute Pain Service were discussed in the group. This study evaluates the benefits of this interaction. This study was approved by the hospital ethics board and was registered with the Clinical Trial Registry of India. Second- and third-year anesthesia residents were included in a WhatsApp group, along with consultants (board certified anesthesiologists with a special interest in pain). Pain knowledge assessment was performed pre- and post-discussion using a standard 22-point questionnaire. A feedback form, which included self-rated confidence scores (1-10, 10-most confident) and opinions about the 3-month WhatsApp discussion, was collected. Improvements in the documentation in clinical sheets post-discussion were also analyzed. A total of 38 residents were included in the WhatsApp group. An improvement in the percentage of correct answers from 69.1% (pre-discussion) to 73.6% (post-discussion) was observed (P = 0.031). Improvements in the self-rated residents' confidence levels were also noted (P WhatsApp-based discussion was useful. Documentation of the details of epidural blockade in clinical sheets improved from 30% to 100%. The WhatsApp discussion improved residents' knowledge and confidence levels, and also resulted in improved documentation of essential details in the clinical notes. This form of education is promising and should be explored in future studies.

  1. Determinants of continuance intention in a post-adoption satisfaction evaluation of a clinical information system.

    Science.gov (United States)

    Hadji, Brahim; Dupuis, Isabelle; Leneveut, Laurence; Heudes, Didier; Wagner, Jean-François; Degoulet, Patrice

    2014-01-01

    The evaluation of end-user satisfaction is an essential part of any clinical information system (CIS) project. The purpose of this study is to evaluate the determinants of CIS continuance intention in a late post-adoption phase at the Georges Pompidou University Hospital (HEGP) in Paris. We designed an electronic survey instrument based on an IT post-adoption model (ITPAM) developed from three previous models, i.e., the Delone and McLean Information Success Model, the Davis TAM model and the Bhattacherjee information system continuance intention model. 419 questionnaires were collected from CIS users directly involved in patient care. The perceived CIS quality, usefulness and user satisfaction are significantly lower for medical professions than other professional groups. Continuance intention is very high within all professional subgroups. In a multiple regression analysis, the global satisfaction (R(2) = .780) was positively and significantly correlated with CIS quality, confirmation of expectations and perceived CIS usefulness. The continuance intention (R(2) = .392) was positively and significantly correlated with perceived CIS usefulness, confirmation of expectations and global satisfaction. In a late post-adoption CIS deployment phase, continuance intention does not significantly depend on individual end user characteristics but is significantly associated with the perceived CIS usefulness, confirmation of expectations and global satisfaction.

  2. The new on-line marketing medium: viral marketing. Analysis of the field through two case studies

    OpenAIRE

    Sasigain Salvador, Miren

    2014-01-01

    Purpose: This paper synthesizes the emerging literature on viral marketing through the analysis of two case studies and identifies and evaluates important factors that need to be considered when organizing a viral marketing campaign nowadays; the elements used the implemented strategy, the impact and results. The companies to be studied have been successful developing viral marketing strategies even they differ in size, sector and product offered. Literature Review: Definition of tradition...

  3. A post-hoc subgroup analysis of outcomes in the first phase III clinical study of edaravone (MCI-186) in amyotrophic lateral sclerosis.

    Science.gov (United States)

    2017-10-01

    Our first phase III study failed to demonstrate efficacy of edaravone for amyotrophic lateral sclerosis (ALS) compared to placebo. Here, we performed post-hoc subgroup analysis to identify a subgroup in which edaravone might be expected to show efficacy. We focussed on two newly defined subgroups, EESP and dpEESP2y. The EESP was defined as the efficacy-expected subpopulation with % forced vital capacity of ≥80%, and ≥2 points for all item scores in the revised ALS functional rating scale (ALSFRS-R) score before treatment. The dpEESP2y was defined as the greater-efficacy-expected subpopulation within EESP having a diagnosis of 'definite' or 'probable' ALS according to the El Escorial revised Airlie House diagnostic criteria and onset of disease within two years. The primary endpoint of the post-hoc analysis was the change in the ALSFRS-R score during the 24-week treatment period. The intergroup differences of the least-squares mean change in the ALSFRS-R score ± standard error during treatment were 0.65 ± 0.78 (p = 0.4108) in the full analysis set, 2.20 ± 1.03 (p = 0.0360) in the EESP, and 3.01 ± 1.33 (p = 0.0270) in the dpEESP2y. Edaravone exhibited efficacy in the dpEESP2y subgroup. A further clinical study in patients meeting dpEESP2y criteria is warranted.

  4. Empirical Studies on Sovereign Fixed Income Markets

    NARCIS (Netherlands)

    J.G. Duyvesteyn (Johan)

    2015-01-01

    markdownabstractAbstract This dissertation presents evidence of five studies showing that sovereign fixed income markets are not always price efficient. The emerging local currency debt market has grown to a large size of more than 1.5 trill ion US Dollars at the end of 2012. The factors

  5. Transforming the energy efficiency market in California: Key findings, lessons learned and future directions from California's market effects studies

    International Nuclear Information System (INIS)

    Vine, Edward

    2013-01-01

    In the last three years, the California Institute for Energy and Environment (CIEE), along with the California Public Utilities Commission (CPUC), managed three market effects studies that were funded by the CPUC. This paper summarizes the key findings from these studies that focused on compact fluorescent lamps (CFLs), residential new construction (RNC), and high bay lighting (HBL), with a particular focus on changes to California's market effects evaluation protocol and lessons learned during the evaluation of market effects. This paper also summarizes the key results from a survey that was conducted by CIEE in February 2011 to determine what additional studies should be conducted in the evaluation of market effects. - Highlights: • We summarize three market effects studies and provide lessons learned. • Collect baseline market data as early as possible and throughout program lifecycle. • Estimate market effects throughout a program's lifecycle. • Require hypothesis testing as part of the evaluation. • Include elements of market effects evaluation in other program evaluations

  6. 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 pai