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Sample records for plato trial ticagrelor

  1. Protecting the pipeline of science: openness, scientific methods and the lessons from ticagrelor and the PLATO trial.

    Science.gov (United States)

    Coats, Andrew J Stewart; Nijjer, Sukhjinder S; Francis, Darrel P

    2014-10-20

    Ticagrelor, a potent antiplatelet, has been shown to be beneficial in patients with acute coronary syndromes in a randomised controlled trial published in a highly ranked peer reviewed journal. Accordingly it has entered guidelines and has been approved for clinical use by authorities. However, there remains a controversy regarding aspects of the PLATO trial, which are not immediately apparent from the peer-reviewed publications. A number of publications have sought to highlight potential discrepancies, using data available in publicly published documents from the US Food and Drug Administration (FDA) leading to disagreement regarding the value of open science and data sharing. We reflect upon potential sources of bias present in even rigorously performed randomised controlled trials, on whether peer review can establish the presence of bias and the need to constantly challenge and question even accepted data. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  2. Cardiovascular events in acute coronary syndrome patients with peripheral arterial disease treated with ticagrelor compared to clopidogrel: Data from the PLATO trials

    DEFF Research Database (Denmark)

    Patel, Manesh R.; Becker, Richard C.; Wojdyla, Daniel M.

    Abstract 14299: Cardiovascular Events in Acute Coronary Syndrome Patients With Peripheral Arterial Disease Treated With Ticagrelor Compared to Clopidogrel: Data From the PLATO Trial Manesh R Patel1; Richard C Becker1; Daniel M Wojdyla2; Håkan Emanuelsson3; William Hiatt4; Jay Horrow5; Steen Husted6...... Uppsala, Sweden 10 Cardiology, Uppsala Clinical Rsch center, 75185 Uppsala, Sweden Background: Patients with peripheral artery disease (PAD) and acute coronary syndrome (ACS) are at high risk for clinical events and are often difficult to manage. We evaluated cardiovascular outcomes of ACS patients...

  3. Direct healthcare costs and cost-effectiveness of acute coronary syndrome secondary prevention with ticagrelor compared to clopidogrel: economic evaluation from the public payer's perspective in Poland based on the PLATO trial results.

    Science.gov (United States)

    Pawęska, Justyna; Macioch, Tomasz; Perkowski, Piotr; Budaj, Andrzej; Niewada, Maciej

    2014-01-01

    Ticagrelor is the first reversibly binding oral P2Y12 receptor antagonist designed to reduce clinical thrombotic events in patients with acute coronary syndrome (ACS). Compared to clopidogrel, ticagrelor has been proven to significantly reduce the rate of death from vascular causes, myocardial infarction (MI), or stroke without an increase in the rate of overall major bleeding in patients who have an ACS with or without ST-segment elevation (STEMI and NSTEMI) or unstable angina (UA). To evaluate the cost-effectiveness and healthcare costs associated with secondary prevention of ACS using ticagrelor or clopidogrel in patients after STEMI, NSTEMI and UA. An economic model based on results from the PLATO trial was used to evaluate the cost-effectiveness of one-year therapy with ticagrelor or clopidogrel. The structure of the model consisted of two parts, i.e. the decision tree with one-year PLATO results and the Markov model with lifelong estimations, which exceeded PLATO follow-up data. The model was adjusted to Polish settings with country-specific data on death rates in the general population and direct medical costs calculated from the public payer's perspective. Costs were derived from the National Health Fund (NHF) and the Ministry of Health and presented in PLN 2013 values. Annual mean costs of second and subsequent years after stroke or MI were obtained from the literature. Uncertainty of assumed parameters was tested in scenarios and probabilistic sensitivity analyses. The adopted model allowed the estimation of an incremental cost-effectiveness ratio for life years gained (LYG) and an incremental cost-utility ratio for quality adjusted life years (QALY). Total direct medical costs to the public payer at a one year horizon were 2,905 PLN higher with ticagrelor than with clopidogrel. However, mean healthcare costs at a one year horizon (excluding drug costs and concomitant drugs) were 690 PLN higher for patients treated with clopidogrel. In a lifetime horizon

  4. Ticagrelor

    Directory of Open Access Journals (Sweden)

    Gianluca Airoldi

    2013-03-01

    Full Text Available Antiplatelet drugs are the cornerstone of treatment for patients with acute coronary syndromes (ACS who undergo percutaneous coronary intervention. Clopidogrel and aspirin improve long-term clinical outcomes in these patients and have become a standard of care. However, many patients still experience ischemic/thrombotic events, and it appears that insufficient response to both aspirin and clopidogrel contribute to this failure. Clopidogrel is a prodrug that is metabolized in the liver to its active form. It inhibits platelet aggregation induced by adenosine diphosphate (ADP by irreversibly binding to the ADP purinergic receptor (P2Y12 on the platelet surface. Prasugrel, a novel thienopyridine, exhibits more potent antiplatelet effects with lower interpatient variability and more rapid onsetof activity. All thienopyridines, however, have pharmacological limitations, which have fueled the search for more effective non-thienopyridine P2Y12 inhibitors. Promising results have been reported with ticagrelor, the first oral P2Y12 receptor antagonist with reversible effects. Ticagrelor does not require metabolic activation. In vivo one active metabolite is formed whose potency and pharmacokinetic properties are very similar to those of the parent compound, but it probably plays a minor role in ticagrelor’s antiplatelet effects. Ticagrelor offers more rapid and more pronounced platelet inhibition than other antiplatelet agents. Furthermore, the reversibility of its effects may allow shorter periods of suspension of antiplatelet treatment prior to surgery, reducing the risk of perioperative thrombotic and hemorrhagic events. Preliminary results show a trend toward protection from coronary events and no increased risk for major bleeding compared with clopidogrel. Further investigation is needed, however, to determine the optimal dosage for minimizing bleeding risks and to evaluate its impact on outcomes in various subsets of ACS patients.

  5. Viewpoint: Central adjudication of myocardial infarction in outcome-driven clinical trials--common patterns in TRITON, RECORD, and PLATO?

    Science.gov (United States)

    Serebruany, Victor L; Atar, Dan

    2012-09-01

    Central adjudication in randomised controlled outcome-driven trials represents a traditional approach to maintain data integrity by applying uniformed rules for assessment of clinical events. It was the purpose of this investigation to determine the patterns of myocardial infarction (MI) adjudication in the TRITON, RECORD, and PLATO trials. We were matching centrally-adjudicated MI's (CAMI's) from the official trial publication with the site-reported MI (SRMI's) count from the Food and Drug Administration's secondary analyses for the investigational compounds prasugrel (TRITON), rosiglitazone (RECORD), and ticagrelor (PLATO). CAMI numbers showed a remarkable discrepancy to SRMI's by more than a doubling of the difference: from 72 to 145 events in TRITON favoring prasugrel (from a hazard ratio [HR]=0.76, p=0.08; to a HR=0.76, p<0.001), and from 44 to 89 events in favour of ticagrelor in PLATO (from a HR=0.94, p=0.095; to a HR=0.84, p<0.001). In contrast, in the RECORD trial, the CAMI count was less than the SRMI count (from 24 to 8 events, from a HR=1.42, p=0.93; to a HR=1.14, p=0.96), in this case diminishing cardiovascular hazards in favour of rosiglitazone. In conclusion, central adjudication in the TRITON, the RECORD, and the PLATO trial turned out to have a critical impact on study outcomes. Trial publications should in the future include site-reported major efficacy and safety endpoints to preserve data integrity. The regulatory authorities should consider independent audits when there is a major disagreement between centrally adjudicated and site reported events influencing the results of a major clinical trial.

  6. ST-elevation acute coronary syndromes in the Platelet Inhibition and Patient Outcomes (PLATO) trial

    DEFF Research Database (Denmark)

    Armstrong, Paul W; Siha, Hany; Fu, Yuling

    2012-01-01

    Ticagrelor, when compared with clopidogrel, reduced the 12-month risk of vascular death/myocardial infarction and stroke in patients with ST-elevation acute coronary syndromes intended to undergo primary percutaneous coronary intervention in the PLATelet inhibition and patient Outcomes (PLATO...

  7. Effect of Ticagrelor Plus Aspirin, Ticagrelor Alone, or Aspirin Alone on Saphenous Vein Graft Patency 1 Year After Coronary Artery Bypass Grafting: A Randomized Clinical Trial.

    Science.gov (United States)

    Zhao, Qiang; Zhu, Yunpeng; Xu, Zhiyun; Cheng, Zhaoyun; Mei, Ju; Chen, Xin; Wang, Xiaowei

    2018-04-24

    The effect of ticagrelor with or without aspirin on saphenous vein graft patency in patients undergoing coronary artery bypass grafting (CABG) is unknown. To compare the effect of ticagrelor + aspirin or ticagrelor alone vs aspirin alone on saphenous vein graft patency 1 year after CABG. Randomized, multicenter, open-label, clinical trial among 6 tertiary hospitals in China. Eligible patients were aged 18 to 80 years with indications for elective CABG. Patients requiring urgent revascularization, concomitant cardiac surgery, dual antiplatelet or vitamin K antagonist therapy post-CABG, and who were at risk of serious bleeding were excluded. From July 2014 until November 2015, 1256 patients were identified and 500 were enrolled. Follow-up was completed in January 2017. Patients were randomized (1:1:1) to start ticagrelor (90 mg twice daily) + aspirin (100 mg once daily) (n = 168), ticagrelor (90 mg twice daily) (n = 166), or aspirin (100 mg once daily) (n = 166) within 24 hours post-CABG. Neither patients nor treating physicians were blinded to allocation. Primary outcome was saphenous vein graft patency 1 year after CABG (FitzGibbon grade A) adjudicated independently by a committee blinded to allocation. Saphenous vein graft patency was assessed by multislice computed tomographic angiography or coronary angiography. Among 500 randomized patients (mean age, 63.6 years; women, 91 [18.2%]), 461 (92.2%) completed the trial. Saphenous vein graft patency rates 1 year post-CABG were 88.7% (432 of 487 vein grafts) with ticagrelor + aspirin; 82.8% (404 of 488 vein grafts) with ticagrelor alone; and 76.5% (371 of 485 vein grafts) with aspirin alone. The difference between ticagrelor + aspirin vs aspirin alone was statistically significant (12.2% [95% CI, 5.2% to 19.2%]; P aspirin alone was not statistically significant (6.3% [95% CI, -1.1% to 13.7%]; P = .10). Five major bleeding episodes occurred during 1 year of follow-up (3 with

  8. Risk for Major Bleeding in Patients Receiving Ticagrelor Compared With Aspirin After Transient Ischemic Attack or Acute Ischemic Stroke in the SOCRATES Study (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes).

    Science.gov (United States)

    Easton, J Donald; Aunes, Maria; Albers, Gregory W; Amarenco, Pierre; Bokelund-Singh, Sara; Denison, Hans; Evans, Scott R; Held, Peter; Jahreskog, Marianne; Jonasson, Jenny; Minematsu, Kazuo; Molina, Carlos A; Wang, Yongjun; Wong, K S Lawrence; Johnston, S Claiborne

    2017-09-05

    Patients with minor acute ischemic stroke or transient ischemic attack are at high risk for subsequent stroke, and more potent antiplatelet therapy in the acute setting is needed. However, the potential benefit of more intense antiplatelet therapy must be assessed in relation to the risk for major bleeding. The SOCRATES trial (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes) was the first trial with ticagrelor in patients with acute ischemic stroke or transient ischemic attack in which the efficacy and safety of ticagrelor were compared with those of aspirin. The main safety objective was assessment of PLATO (Platelet Inhibition and Patient Outcomes)-defined major bleeds on treatment, with special focus on intracranial hemorrhage (ICrH). An independent adjudication committee blinded to study treatment classified bleeds according to the PLATO, TIMI (Thrombolysis in Myocardial Infarction), and GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) definitions. The definitions of ICrH and major bleeding excluded cerebral microbleeds and asymptomatic hemorrhagic transformations of cerebral infarctions so that the definitions better discriminated important events in the acute stroke population. A total of 13 130 of 13 199 randomized patients received at least 1 dose of study drug and were included in the safety analysis set. PLATO major bleeds occurred in 31 patients (0.5%) on ticagrelor and 38 patients (0.6%) on aspirin (hazard ratio, 0.83; 95% confidence interval, 0.52-1.34). The most common locations of major bleeds were intracranial and gastrointestinal. ICrH was reported in 12 patients (0.2%) on ticagrelor and 18 patients (0.3%) on aspirin. Thirteen of all 30 ICrHs (4 on ticagrelor and 9 on aspirin) were hemorrhagic strokes, and 4 (2 in each group) were symptomatic hemorrhagic transformations of brain infarctions. The ICrHs were spontaneous in 6 and 13, traumatic in 3 and 3, and procedural in 3 and 2

  9. Changes of ticagrelor formulary tiers in the USA: targeting private insurance providers away from government-funded plans.

    Science.gov (United States)

    Serebruany, Victor L; Dinicolantonio, James J

    2013-01-01

    Ticagrelor (Brilinta®) is a new oral reversible antiplatelet agent approved by the FDA in July 2011 based on the results of the PLATO (Platelet Inhibition and Patient Outcomes) trial. However, despite very favorable and broad indications, the current clinical utilization of ticagrelor is woefully small. We aimed to compare ticagrelor formulary tiers for major private (n = 8) and government-funded (n = 4) insurance providers for 2012-2013. Over the last year, ticagrelor placement improved, becoming a preferred drug (from Tier 3 in 2012 to Tier 2 in 2013) for Medco, moving from Tier 4 (with a prior approval requirement) to Tier 3 (no prior approval) for the United Health Care Private Plan and achieving Tier 3 status for Apex in 2013. In contrast, ticagrelor placement did not improve for New York Medicaid, retaining Tier 3 status. In addition, many Medicare Part D formularies have significantly worse coverage than most private plans. For example, Humana Medicare Part D has Tier 3 status requiring step therapy and quantity limits, SilverScript (CVS Caremark) Part D is Tier 3 and the American Association of Retired Persons (United Health Care) Medicare Part D is Tier 4 requiring prior approval. Ticagrelor formulary placement is significantly better for most private providers than for government-funded plans, which may possibly be due to the selective targeting of private insurance providers and the simultaneous avoidance of government-funded plans. © 2013 S. Karger AG, Basel.

  10. Population pharmacokinetics of ticagrelor in patients with acute coronary syndromes.

    Science.gov (United States)

    Li, Jianguo; Tang, Weifeng; Storey, Robert F; Husted, Steen; Teng, Renli

    2016-09-01

    Ticagrelor is an orally administered antiplatelet agent used to reduce thrombotic events in patients with acute coronary syndromes. Data from two studies in patients with acute coronary syndromes with large amounts of pharmacokinetic (PK) data (phase IIb DISPERSE-2 study (n = 609)); phase III PLATO PK substudy (n = 6,381)), along with non-linear mixed effects modeling software, were used to develop population PK models for ticagrelor and its metabolite, AR-C124910XX, and to evaluate the impact of demographic and clinical factors on the PK of ticagrelor and AR-C124910XX. 32 covariates relating to disease history, biomarkers, clinical chemistry, and concomitant medications were assessed. A one-compartment model with population mean PK parameters of firstorder absorption rate constant (0.67/h), apparent systemic clearance (14 L/h), and apparent volume of distribution (221 L) was shown to best describe the PK profile of ticagrelor. Patients co-administered moderate CYP3A inducers or inhibitors increased (by 110%, 95% confidence interval (CI), 52 - 192%) or decreased (by 64%, 95% CI, 39 - 73%) apparent ticagrelor clearance, respectively, while habitual smoking decreased apparent ticagrelor clearance by 22% (95% CI, 19 - 25%). Ticagrelor bioavailability was 21% (95% CI, 19 - 22%) lower at treatment initiation (visit 1) versus subsequent visits. Compared with Caucasian patients, ticagrelor bioavailability was 39% (95% CI, 33 - 46%) higher in Asian patients and 18% (95% CI, 6 - 28%) lower in Black patients. In the current analyses, the population PK models developed for ticagrelor and AR-C124910XX described the data obtained in the DISPERSE-2 and PLATO studies well, and were consistent with previous phase I PK studies.

  11. Ticagrelor versus clopidogrel in real-world patients with ST elevation myocardial infarction: 1-year results by propensity score analysis

    OpenAIRE

    Vercellino, Matteo; S?nchez, Federico Ariel; Boasi, Valentina; Perri, Dino; Tacchi, Chiara; Secco, Gioel Gabrio; Cattunar, Stefano; Pistis, Gianfranco; Mascelli, Giovanni

    2017-01-01

    Background European guidelines recommend the use of ticagrelor versus clopidogrel in patients with ST elevation myocardial infarction (STEMI). This recommendation is based on inconclusive results and subanalyses from clinical trials. Few data are available on the effects of ticagrelor in a real-world population. Methods To compare the effects of ticagrelor and clopidogrel in a real-world STEMI population, we conducted a pre-post case-control study examining all patients with STEMI included in...

  12. Ticagrelor versus clopidogrel in real-world patients with ST elevation myocardial infarction: 1-year results by propensity score analysis.

    Science.gov (United States)

    Vercellino, Matteo; Sànchez, Federico Ariel; Boasi, Valentina; Perri, Dino; Tacchi, Chiara; Secco, Gioel Gabrio; Cattunar, Stefano; Pistis, Gianfranco; Mascelli, Giovanni

    2017-04-05

    European guidelines recommend the use of ticagrelor versus clopidogrel in patients with ST elevation myocardial infarction (STEMI). This recommendation is based on inconclusive results and subanalyses from clinical trials. Few data are available on the effects of ticagrelor in a real-world population. To compare the effects of ticagrelor and clopidogrel in a real-world STEMI population, we conducted a pre-post case-control study examining all patients with STEMI included in the Cardio-STEMI Sanremo registry between February 2011 and June 2013. Cases and controls were defined according to P2Y 12 inhibitors, correcting the bias due to lack of randomization by propensity score analysis. Ticagrelor was introduced in 2012 in both in-hospital and pre-hospital settings independently of this study. Of the 416 patients enrolled in the Cardio-STEMI registry, 401 with a definite diagnosis of STEMI were included in this study. One hundred forty-two patients received ticagrelor and 259 received clopidogrel. Regarding clinical presentation and procedural data, those in the ticagrelor group had lower CRUSADE scores (23 [14-36] vs 27 [18-38]; p = 0.015] but a higher proportion of radial access (33% vs 14%; p word propensity score analysis, ticagrelor did not affect the risk of MACE during the hospital phase, or the incidence of hospital bleeding in patients with STEMI. However, in this mono-centric experience, ticagrelor resulted in improved 1-year survival, even after correction by propensity score.

  13. Ticagrelor Improves Endothelial Function by Decreasing Circulating Epidermal Growth Factor (EGF

    Directory of Open Access Journals (Sweden)

    Francesco Vieceli Dalla Sega

    2018-04-01

    Full Text Available Ticagrelor is one of the most powerful P2Y12 inhibitor. We have recently reported that, in patients with concomitant Stable Coronary Artery Disease (SCAD and Chronic Obstructive Pulmonary Disease (COPD undergoing percutaneous coronary intervention (PCI, treatment with ticagrelor, as compared to clopidogrel, is associated with an improvement of the endothelial function (Clinical Trial NCT02519608. In the present study, we showed that, in the same population, after 1 month treatment with ticagrelor, but not with clopidogrel, there is a decrease of the circulating levels of epidermal growth factor (EGF and that these changes in circulating levels of EGF correlate with on-treatment platelet reactivity. Furthermore, in human umbilical vein endothelial cells (HUVEC incubated with sera of the patients treated with ticagrelor, but not with clopidogrel there is an increase of p-eNOS levels. Finally, analyzing the changes in EGF and p-eNOS levels after treatment, we observed an inverse correlation between p-eNOS and EGF changes only in the ticagrelor group. Causality between EGF and eNOS activation was assessed in vitro in HUVEC where we showed that EGF decreases eNOS activity in a dose dependent manner. Taken together our data indicate that ticagrelor improves endothelial function by lowering circulating EGF that results in the activation of eNOS in the vascular endothelium.

  14. Finding Ernst Mayr's Plato.

    Science.gov (United States)

    Powers, Jack

    2013-12-01

    Many biologists have accepted Ernst Mayr's claim that evolutionary biology undermined an essentialist or typological view of species that had its roots in Platonic philosophy. However, Mayr has been accused of failing to support with textual evidence his attributions to Plato of these sorts of views about biology. Contemporary work in history and philosophy of biology often seems to take onboard Mayr's account of Plato's view of species. This paper seeks to provide a critical account of putative inconsistencies between an evolutionary view of species and Platonic philosophy with renewed attention to the Platonic texts in light of recent Plato scholarship; I argue that claims that Plato held an essentialist view of species inconsistent with evolutionary biology are inadequately supported by textual evidence. If Mayr's essentialist thesis fails, one might think that the intuition that Platonic philosophy is in tension with Darwinian evolution could nonetheless be accounted for by Plato's apparent privileging of a certain sort of teleological explanation, a thesis that Mayr suggests in his 1959 paper on Louis Agassiz. However, this thesis also faces difficulties. Ernst Mayr's Plato is more likely to be found in the writings of anti-evolutionary 19th century biologists like Mayr's frequent target, Agassiz, than in a cautious reading of the Platonic dialogues themselves. Interlocutors in discussions of the history of biological thought and classificatory methods in biology should be cautious in ascribing views about biology to Plato and using terms like "Platonic essentialism." Copyright © 2013 Elsevier Ltd. All rights reserved.

  15. [Plato psychiatrist, Foucault platonic].

    Science.gov (United States)

    Mathov, Nicolás

    2016-05-01

    This work explores the links between the concepts of "soul", "law" and "word" in Plato's work, in order to highlight the importance and the centrality of the philosophical-therapeutic dimension in the Greek philosopher's thought. In that way, this work pretends to show that "contemporary" problems usually discussed within "Human Sciences" in general, and Psychiatry in particular, should confront their knowledge with Plato's work, mainly due to the profound influence his ideas have had in our Greco-Christian culture. In that sense, and with that objective, this work also explores Michel Foucault's lucid and controversial interpretation of Plato.

  16. Long-term cost-effectiveness of ticagrelor versus clopidogrel in acute coronary syndrome in Spain

    Directory of Open Access Journals (Sweden)

    E. Molina-Cuadrado

    2014-07-01

    Full Text Available Objective: To assess the cost-effectiveness relationship of Ticagrelor versus Clopidogrel for the management of acute coronary syndrome in Spain. Methods: The data from the PLATO study were used for the calculation of the events rate and health-related quality of life for Ticagrelor and Clopidogrel for the first 12 months, whereas the costs were obtained from Spanish sources. Quality of lifeadjusted survival and costs were estimated according to the fact that the patients did not suffer any thrombotic event (myocardial infarction or ictus or this one was not fatal. The lifetime cots, life years gained, and the quality of life-adjusted survival were estimated for both treatment arms. Incremental costeffectiveness ratios were assessed through the perspective of the Spanish healthcare system for 2013, by using a macro-costs strategy based on published literature and the survival tables for the Spanish population. Results: Treatment with Ticagrelor was associated to an incremental cost of 1,228 per year, an increase in 0.1652 life years gained, and 0.1365 years adjusted by quality of life, as compared to Clopidogrel. The cost for one quality of life-adjusted life year was 8,997 and the cost per one gained life year of 7,435 . The sensitivity analysis showed consistent results. Conclusions: Treatment of acute coronary syndrome for 12 months with Ticagrelor was associated with a cost per 1 life year of quality of life-adjusted cost below the cost-effectiveness limits generally accepted in Spain.

  17. PLATO Esperanto Materials.

    Science.gov (United States)

    Sherwood, Judith

    1981-01-01

    A summary is presented of types of Esperanto materials available on PLATO--a general overview section, a picture introduction, lessons that accompany a textbook, vocabulary drills, crossword puzzles, dictation drills, reading practice, and a concentration game. The general overview lesson gives a comprehensive summary of the history and…

  18. PLATO IV Accountancy Index.

    Science.gov (United States)

    Pondy, Dorothy, Comp.

    The catalog was compiled to assist instructors in planning community college and university curricula using the 48 computer-assisted accountancy lessons available on PLATO IV (Programmed Logic for Automatic Teaching Operation) for first semester accounting courses. It contains information on lesson access, lists of acceptable abbreviations for…

  19. Comparison of bioavailability and antiplatelet action of ticagrelor in patients with ST-elevation myocardial infarction and non-ST-elevation myocardial infarction: A prospective, observational, single-centre study.

    Directory of Open Access Journals (Sweden)

    Piotr Adamski

    Full Text Available Data from available studies suggest that the presence of ST-elevation myocardial infarction (STEMI may be associated with delayed and attenuated ticagrelor bioavailability and effect compared with non-ST-elevation myocardial infarction (NSTEMI.In a single-center, prospective, observational trial 73 patients with myocardial infarction (STEMI n = 49, NSTEMI n = 24 underwent a pharmacokinetic and pharmacodynamic assessment after a 180 mg ticagrelor loading dose (LD. Ticagrelor and its active metabolite (AR-C124910XX plasma concentrations were determined with liquid chromatography tandem mass spectrometry, and their antiplatelet effect was measured with the VASP assay and multiple electrode aggregometry.During the first six hours after ticagrelor LD, STEMI patients had 38% and 34% lower plasma concentration of ticagrelor and AR-C124910XX, respectively, than NSTEMI (ticagrelor AUC(0-6: 2491 [344-5587] vs. 3991 [1406-9284] ng*h/mL; p = 0.038; AR-C124910XX AUC(0-6: 473 [0-924] vs. 712 [346-1616] ng*h/mL; p = 0.027. STEMI patients also required more time to achieve maximal concentration of ticagrelor (tmax: 4.0 [3.0-12.0] vs. 2.5 [2.0-6.0] h; p = 0.012. Impaired bioavailability of ticagrelor and AR-C124910XX seen in STEMI subjects was associated with diminished platelet inhibition in this group, which was most pronounced during the initial hours of treatment.Plasma concentrations of ticagrelor and AR-C124910XX during the first hours after ticagrelor LD were one third lower in STEMI than in NSTEMI patients. This reduced and delayed ticagrelor bioavailability was associated with weaker antiplatelet effect in STEMI.ClinicalTrials.gov identifier: NCT02602444 (November 09, 2015.

  20. From Pericles to Plato

    DEFF Research Database (Denmark)

    Larsen, Øjvind

    2012-01-01

    Plato is normally taken as one of the founders of Western political philosophy, not at least with his Republic. Here, he constructs a hierarchy of forms of governments, beginning with aristocracy at the top as a critical standard for the other forms of governments, and proceeding through timocracy......’ funeral oration is used to show that Pericles presented a democratic political philosophy that can serve as a counterpoint to Plato’s political philosophy in the Republic....

  1. Peers on Socrates and Plato

    Science.gov (United States)

    Mackenzie, Jim

    2014-01-01

    There is more to be said about two of the topics Chris Peers addresses in his article "Freud, Plato and Irigaray: A morpho-logic of teaching and learning" (2012, Educational Philosophy and Theory, 44, 760-774), namely the Socratic method of teaching and Plato's stance with regard to women and feminism. My purpose in this article is…

  2. Baseline Q waves as a prognostic modulator in patients with ST-segment elevation: insights from the PLATO trial.

    Science.gov (United States)

    Siha, Hany; Das, Debraj; Fu, Yuling; Zheng, Yinggan; Westerhout, Cynthia M; Storey, Robert F; James, Stefan; Wallentin, Lars; Armstrong, Paul W

    2012-07-10

    Baseline Q waves may provide additional value compared with time from the onset of symptoms in predicting outcomes for patients with ST-segment elevation. We evaluated whether baseline Q waves superseded time from symptom onset as a prognostic marker of one-year mortality in patients with ST-segment elevation acute coronary syndrome. Our study was derived from data from patients undergoing primary percutaneous coronary intervention within 24 hours in the PLATelet inhibition and patient Outcomes trial Q waves on the baseline electrocardiogram were evaluated by a blinded core laboratory. We assessed the associations between baseline Q waves and time from symptom onset to percutaneous coronary intervention with peak biomarkers, ST-segment resolution on the discharge electrocardiogram, and one-year all-cause and vascular mortality. Of 4341 patients with ST-segment elevation, 46% had baseline Q waves. Compared to those without Q waves, those with baseline Q waves were older, more frequently male, had higher heart rates, more advanced Killip class and had a longer time between the onset of symptoms and percutaneous coronary intervention. They also had higher one-year all-cause mortality than patients without baseline Q waves (baseline Q waves: 4.9%; no baseline Q waves: 2.8%; hazard ratio [HR] 1.78, 95% confidence interval [CI] 1.29-2.45, p waves. After multivariable adjustment, baseline Q waves, but not time from symptom onset, were associated with a significant increase in all-cause mortality (adjusted HR 1.42, 95% CI 1.10-2.01, p = 0.046) and vascular mortality (adjusted HR 1.58, 95% CI 1.09-2.28, p = 0.02). The presence of baseline Q waves provides useful additional prognostic insight into the clinical outcome of patients with ST-segment elevation. Clinical Trials.gov registration no. NCT00391872.

  3. Plato's patricide in the sophist

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    Deretić Irina J.

    2012-01-01

    Full Text Available In this paper, the author attempts to elucidate validity of Plato's criticism of Parmenides' simplified monistic ontology, as well as his concept of non-being. In contrast to Parmenides, Plato introduces a more complex ontology of the megista gene and redefines Parmenides' concept of non-being as something absolutely different from being. According to Plato, not all things are in the same sense, i. e. they have the different ontological status. Additionally, he redefines Parmenides' concept of absolute non-being as 'difference' or 'otherness.' .

  4. Phusis and Nomos in Plato

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    Zahra Nouri Sanghdehi

    2017-07-01

    Full Text Available One of the greatest problems in Plato that appears in different forms in his works is the relation of nomos and phusis. This thesis has been in fifth century B.C as the contradiction of phusis and nomos among big thinkers. In this essay, we tried to investigate the relation of phusis and nomos in Plato’s thoughts according to current theories of the contradiction of these in dialogues Gorgias, Republic and Protagoras. Plato tries to minimize consequences of belief to contradiction of phusis and nomos in social and political life by assertion large scale relation between phusis and nomos. Plato depicts the ultimate solution of this problem in Law. There he accounts nomos as raised from phusis that is sub sovereignty of divine. Indeed union of phusis and gods in Plato’s thought is sanction for the identity of phusis and nomos.

  5. Pre-hospital ticagrelor in patients with ST-segment elevation myocardial infarction with long transport time to primary PCI facility.

    Science.gov (United States)

    Lupi, Alessandro; Schaffer, Alon; Lazzero, Maurizio; Tessitori, Massimo; De Martino, Leonardo; Rognoni, Andrea; Bongo, Angelo S; Porto, Italo

    2016-12-01

    Pre-hospital ticagrelor, given less than 1h before coronary intervention (PCI), failed to improve coronary reperfusion in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary PCI. It is unknown whether a longer interval from ticagrelor administration to primary PCI might reveal any improvement of coronary reperfusion. We retrospectively compared 143 patients, pre-treated in spoke centers or ambulance with ticagrelor at least 1.5h before PCI (Pre-treatment Group), with 143 propensity score-matched controls treated with ticagrelor in the hub before primary PCI (Control Group) extracted from RENOVAMI, a large observational Italian registry of more than 1400 STEMI patients enrolled from Jan. 2012 to Oct. 2015 (ClinicalTrials.gov id: NCT01347580). The median time from ticagrelor administration and PCI was 2.08h (95% CI 1.66-2.84) in the Pre-treatment Group and 0.56h (95% CI 0.33-0.76) in the Control Group. TIMI flow grade before primary PCI in the infarct related artery was the primary endpoint. The primary endpoint, baseline TIMI flow grade, was significantly higher in Pre-treatment Group (0.88±1.14 vs 0.53±0.86, P=0.02). However in-hospital mortality, in-hospital stent thrombosis, bleeding rates and other clinical and angiographic outcomes were similar in the two groups. In a real world STEMI network, pre-treatment with ticagrelor in spoke hospitals or in ambulance loading at least 1.5h before primary PCI is safe and might improve pre-PCI coronary reperfusion, in comparison with ticagrelor administration immediately before PCI. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Four Educators in Plato's "Theaetetus"

    Science.gov (United States)

    Mintz, Avi I.

    2011-01-01

    Scholars who have taken interest in "Theaetetus'" educational theme argue that Plato contrasts an inferior, even dangerous, sophistic education to a superior, philosophical, Socratic education. I explore the contrasting exhortations, methods, ideals and epistemological foundations of Socratic and Protagorean education and suggest that Socrates'…

  7. Safety and Tolerability of Transitioning from Cangrelor to Ticagrelor in Patients Who Underwent Percutaneous Coronary Intervention.

    Science.gov (United States)

    Badreldin, Hisham A; Carter, Danielle; Cook, Bryan M; Qamar, Arman; Vaduganathan, Muthiah; Bhatt, Deepak L

    2017-08-01

    The 3 phase 3 CHAMPION (Cangrelor vs Standard Therapy to Achieve Optimal Management of Platelet Inhibition) trials collectively demonstrated the safety of transitioning from cangrelor, a potent, parenteral rapidly-acting P2Y 12 inhibitor, to clopidogrel in patients who underwent percutaneous coronary intervention (PCI). However, variation in timing of therapy, site-specific binding, and drug half-lives may theoretically complicate switching to other oral P2Y 12 inhibitors. Since regulatory approval, limited data are available regarding the "real-world" safety and tolerability of transitioning to these more potent oral P2Y 12 antagonists. From November 2015 to January 2017, we evaluated the clinical profiles and efficacy and safety outcomes in cangrelor-treated patients who underwent PCI transitioned to clopidogrel (n = 42) or ticagrelor (n = 82) at a large, tertiary care center. Most patients receiving cangrelor underwent PCI with a drug-eluting stent for acute coronary syndrome via a radial approach in the background of unfractionated heparin. Stent thrombosis within 48 hours was rare and occurred in 1 patient treated with ticagrelor. Global Use of Strategies to Open Occluded Coronary Arteries-defined bleeding occurred in 20% of patients switched to ticagrelor and 29% of patients switched to clopidogrel, but none were severe or life-threatening. In conclusion, rates of stent thrombosis and severe/life-threatening bleeding were low and comparable with those identified in the CHAMPION program, despite use of more potent oral P2Y 12 inhibition. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Relations as Plural-Predications in Plato

    OpenAIRE

    Scaltsas, Theodore

    2013-01-01

    Plato was the first philosopher to discover the metaphysical phenomenon of plural-subjects and plural-predication; e.g. you and I are two, but neither you, nor I are two. I argue that Plato devised an ontology for plural-predication through his Theory of Forms, namely, plural-partaking in a Form. Furthermore, I argue that Plato used plural-partaking to offer an ontology of related individuals without reifying relations. My contention is that Plato’s theory of plural-relatives has evaded detec...

  9. Ticagrelor-Induced Angioedema: A Rare and Unexpected Phenomenon

    Directory of Open Access Journals (Sweden)

    Rajeev Seecheran

    2017-01-01

    Full Text Available Angioedema can cause potentially life-threatening airway obstruction. This case report describes an exceedingly rare episode of ticagrelor-induced hypersensitivity reaction, manifesting as angioedema with periorbital and likely respiratory involvement. The heart team should be vigilant for this precarious condition which may require emergent airway management. Desensitization protocols and alternative regimens (e.g., clopidogrel, prasugrel, and addition of an adjunctive anticoagulant should be considered when there is an absolute indication for antiplatelet therapy.

  10. Pharmacodynamic Comparison of Prasugrel Versus Ticagrelor in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease: The OPTIMUS (Optimizing Antiplatelet Therapy in Diabetes Mellitus)-4 Study.

    Science.gov (United States)

    Franchi, Francesco; Rollini, Fabiana; Aggarwal, Niti; Hu, Jenny; Kureti, Megha; Durairaj, Ashwin; Duarte, Valeria E; Cho, Jung Rae; Been, Latonya; Zenni, Martin M; Bass, Theodore A; Angiolillo, Dominick J

    2016-09-13

    Patients with diabetes mellitus (DM) are at increased risk of atherothrombotic events, underscoring the importance of effective platelet inhibiting therapies. Prasugrel and ticagrelor reduce thrombotic complications to a greater extent than clopidogrel. Subgroup analyses of pivotal clinical trials testing prasugrel and ticagrelor versus clopidogrel showed DM patients to have benefits that were consistent with the overall trial populations, although the magnitude of the ischemic risk reduction appeared to be enhanced with prasugrel. Whether these findings may be attributed to differences in the pharmacodynamic profiles of these drugs in DM patients remains poorly explored and represented the aim of this study. In this prospective, randomized, double-blind, double-dummy, crossover pharmacodynamic study, aspirin-treated DM patients (n=50) with coronary artery disease were randomly assigned to receive prasugrel (60 mg loading dose [LD]/10 mg maintenance dose once daily) or ticagrelor (180 mg LD/90 mg maintenance dose twice daily) for 1 week. Pharmacodynamic assessments were conducted using 4 different assays, including VerifyNow P2Y12, vasodilator-stimulated phosphoprotein, light transmittance aggregometry, and Multiplate, which allowed us to explore ADP- and non-ADP-induced (arachidonic acid-, collagen-, thrombin receptor-activating, peptide-induced) platelet signaling pathways. The acute (baseline, 30 minutes, and 2 hours post-LD) and maintenance (1 week) effects of therapy were assessed. The primary end point of the study was the comparison of P2Y12 reaction units determined by VerifyNow P2Y12 at 1 week between prasugrel and ticagrelor. ADP- and non-ADP-induced measures of platelet reactivity reduced significantly with both prasugrel and ticagrelor LD and maintenance dose. P2Y12 reaction units defined by VerifyNow were similar between prasugrel and ticagrelor at 30 minutes and 2 hours post-LD. At 1 week, P2Y12 reaction units were significantly lower with ticagrelor

  11. The Method of Hypothesis in Plato's Philosophy

    Directory of Open Access Journals (Sweden)

    Malihe Aboie Mehrizi

    2016-09-01

    Full Text Available The article deals with the examination of method of hypothesis in Plato's philosophy. This method, respectively, will be examined in three dialogues of Meno, Phaedon and Republic in which it is explicitly indicated. It will be shown the process of change of Plato’s attitude towards the position and usage of the method of hypothesis in his realm of philosophy. In Meno, considering the geometry, Plato attempts to introduce a method that can be used in the realm of philosophy. But, ultimately in Republic, Plato’s special attention to the method and its importance in the philosophical investigations, leads him to revise it. Here, finally Plato introduces the particular method of philosophy, i.e., the dialectic

  12. Plato's Anti-Kohlbergian Program for Moral Education

    Science.gov (United States)

    Jonas, Mark E.

    2016-01-01

    Following Lawrence Kohlberg it has been commonplace to regard Plato's moral theory as "intellectualist", where Plato supposedly believes that becoming virtuous requires nothing other than "philosophical knowledge or intuition of the ideal form of the good". This is a radical misunderstanding of Plato's educational programme,…

  13. Critical appraisal of ticagrelor in the management of acute coronary syndrome

    Directory of Open Access Journals (Sweden)

    Nawarskas JJ

    2011-12-01

    Full Text Available James J Nawarskas, Stanley S SnowdenUniversity of New Mexico College of Pharmacy, Albuquerque, NM, USAAbstract: Ticagrelor is a novel P2Y12 receptor antagonist which, like clopidogrel and prasugrel, functions by blocking adenosine diphosphate-mediated platelet aggregation. However, unlike the aforementioned agents, the binding of ticagrelor to this receptor is reversible. Ticagrelor is also believed to mediate some of its beneficial effects by augmenting the effects of adenosine, which is another unique pharmacologic property of this drug. In terms of antiplatelet effect, ticagrelor is more potent than clopidogrel and produces a faster and stronger inhibition of platelet aggregation. This may also be an advantage of ticagrelor over prasugrel, but this has not been adequately studied. Due to the reversible nature of the binding of ticagrelor to the platelet receptor, ticagrelor has a relatively fast offset of effect, with platelet aggregation approaching pretreatment levels about 3 days after discontinuation of therapy. This has advantages in patients requiring invasive procedures, but also makes medication adherence very important in order to be able to maintain an effective antiplatelet effect. Ticagrelor has been shown to be clinically superior to clopidogrel when given to patients with an acute coronary syndrome, resulting in significantly lower rates of myocardial infarction and vascular death. However, ticagrelor is indicated to be administered with aspirin, and the clinical benefits of ticagrelor may be less when daily dosages of aspirin exceed 100 mg. As expected, bleeding is the most common adverse effect with ticagrelor, although it occurs at rates comparable with those seen for clopidogrel with the exception of noncoronary artery bypass graft-related major bleeding and fatal intracranial bleeds, the latter of which occurs only rarely. Dyspnea is another common adverse effect with ticagrelor, although this is usually not severe and

  14. Plato's problem an introduction to mathematical platonism

    CERN Document Server

    Panza, M

    2013-01-01

    What is mathematics about? And how can we have access to the reality it is supposed to describe? The book tells the story of this problem, first raised by Plato, through the views of Aristotle, Proclus, Kant, Frege, Gödel, Benacerraf, up to the most recent debate on mathematical platonism.

  15. The PLATO 2.0 mission

    NARCIS (Netherlands)

    Rauer, H.; et al., [Unknown; Hekker, S.

    2014-01-01

    PLATO 2.0 has recently been selected for ESA’s M3 launch opportunity (2022/24). Providing accurate key planet parameters (radius, mass, density and age) in statistical numbers, it addresses fundamental questions such as: How do planetary systems form and evolve? Are there other systems with planets

  16. Quoting Plato in Porphyrius' Cuestiones homericas

    Directory of Open Access Journals (Sweden)

    Lucía Rodríguez‑Noriega Guillén

    2016-08-01

    Full Text Available This paper studies the quotations of Plato in Porphyry’s Homeric Questions,including their typology (literal quotation, allusion, paraphrase, etc., their beingor not direct citations, their function in the work, and their possible parallels inother authors.

  17. Socrates the Pythagorean: an Invention of Plato?

    Directory of Open Access Journals (Sweden)

    Yury Shichalin

    2012-06-01

    Full Text Available This article discusses the image of Socrates as found in the Works of Plato and Aristophanes. The author discovers Pythagorean traits in the image of Socrates as portrayed by these two ancient authors. The author also discusses the Pythagoreans and their role in the creation of stable schools of Philosophy. He likewise shows that the sophists were not the only ones contributing to the creation of centres of education and learning in the ancient world

  18. Pemikiran Epistemologi Barat: dari Plato Sampai Gonseth

    OpenAIRE

    Nunu Burhanuddin

    2015-01-01

    This paper riviewing the Western epistemology thought. The theme focuses on Plato to Gonseth. The Epistemology that referred in this article, is to think about "how humans acquire knowledge?". From this then appear four types of sect modern western epistemology thought, namely: sect of empiricism, rationalism sect, kantinian sect, sect of positivism. Furthermore, the social positivism sciences developed by Comte leaves serious problems associated with the loss of the role of the subject. This...

  19. Ancient Doctrines of Passions: Plato and Aristotle

    Directory of Open Access Journals (Sweden)

    Iskra-Paczkowska Agnieszka

    2016-09-01

    Full Text Available The subject of this essay is a discussion of the doctrines of emotions of Plato and Aristotle. According to both them it is impossible to oust the passions from the good, i.e. happy life. On the contrary, emotions are an important component of human excellence. We investigate this question with reference to Plato’s doctrine of the soul and his concept of a perfect life, and Aristotle’s ethics, poetics and rhetoric.

  20. Evaluating PLATO: postgraduate teaching and learning online.

    Science.gov (United States)

    Brown, Menna; Bullock, Alison

    2014-02-01

      The use of the Internet as a teaching medium has increased rapidly over the last decade. PLATO (postgraduate learning and teaching online) was launched in 2008 by the e-learning unit (ELU) of Wales Deanery. Located within Learning@NHSWales, a Moodle virtual learning environment (VLE), it hosts a wide range of freely available courses and resources tailored to support the education, training and continuing professional development (CPD) needs of health care professionals working across the National Health Service (NHS) Wales. The evaluation aimed to identify the costs and benefits of PLATO, report its value as attributed by users, identify potential cost savings and make recommendations.   Five courses (case studies) were selected, representing the range of available e-learning resources: e-induction; fetal heart monitoring; cervical screening; GP prospective trainers; and tools for trainers. Mixed methods were used: one-to-one qualitative interviews, focus group discussions and surveys explored user views, and identified individual and organisational value.   Qualitative findings identified six key areas of value for users: ELU support and guidance; avoidance of duplication and standardisation; central reference; local control; flexibility for learners; and specific features. Survey results (n=72) indicated 72 per cent of consultants reported that PLATO was easy to access and user friendly. E-learning was rated as 'very/important' for CPD by 79 per cent of respondents. Key challenges were: access, navigation, user concerns, awareness and support.   PLATO supports education and helps deliver UK General Medical Council standards. Future plans should address the suggested recommendations to realise cost savings for NHS Wales and the Wales Deanery. The findings have wider applicability to others developing or using VLEs. © 2014 John Wiley & Sons Ltd.

  1. Dual antiplatelet therapy with prasugrel or ticagrelor versus clopidogrel in interventional cardiology

    DEFF Research Database (Denmark)

    Clemmensen, Peter; Dridi, Nadia Paarup; Holmvang, Lene

    2013-01-01

    For several years, clopidogrel plus aspirin has been the dual antiplatelet therapy (DAPT) of choice for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) with stent implantation. More recently, prasugrel and ticagrelor have demonstrated greater effica...

  2. Pemikiran Epistemologi Barat: dari Plato Sampai Gonseth

    Directory of Open Access Journals (Sweden)

    Nunu Burhanuddin

    2015-06-01

    Full Text Available This paper riviewing the Western epistemology thought. The theme focuses on Plato to Gonseth. The Epistemology that referred in this article, is to think about "how humans acquire knowledge?". From this then appear four types of sect modern western epistemology thought, namely: sect of empiricism, rationalism sect, kantinian sect, sect of positivism. Furthermore, the social positivism sciences developed by Comte leaves serious problems associated with the loss of the role of the subject. This problem being the background of epistemology philosophy appears that by Emund Husserl developed through the phenomenology, Habermas through hermeneutics, and Ferdinand Gonseth through critical theory.

  3. Plato's ghost the modernist transformation of mathematics

    CERN Document Server

    Gray, Jeremy

    2008-01-01

    Plato's Ghost is the first book to examine the development of mathematics from 1880 to 1920 as a modernist transformation similar to those in art, literature, and music. Jeremy Gray traces the growth of mathematical modernism from its roots in problem solving and theory to its interactions with physics, philosophy, theology, psychology, and ideas about real and artificial languages. He shows how mathematics was popularized, and explains how mathematical modernism not only gave expression to the work of mathematicians and the professional image they sought to create for themselves, but how modernism also introduced deeper and ultimately unanswerable questions

  4. Plato the Pederast: Rhetoric and Cultural Procreation in the Dialogues.

    Science.gov (United States)

    Ervin, Elizabeth

    1993-01-01

    Examines Plato's Dialogues by reading them through two cultural lenses: the role of eros in classical Greece and its analogous relationship to language and rhetoric; and the educational function of eros within the ancient institution of pederasty. Shows how the cultural values of ancient Greece manifested themselves in Plato's erotic educational…

  5. Plato's Theories of Knowledge and Education: an Examination of the ...

    African Journals Online (AJOL)

    Plato's Theories of Knowledge and Education: an Examination of the Interpretations of Cloete and Agyemang. ... UJAH: Unizik Journal of Arts and Humanities ... views, this article reveals some serious logical and factual errors in Cloete's interpretations, and thereby clarifies Plato's epistemology and theories of education.

  6. Plato and the teaching of entrepreneurship studies as general ...

    African Journals Online (AJOL)

    Secondly to use Plato's model of education to stress the importance of the practical aspect of entrepreneurial studies so as to avoid the old syndrome of breeding certificate Laden, theory filled entrepreneurial studies. For Plato, education should be tailored to suit the learner specialization; that is a carpenter should be taught ...

  7. Study of the influence and molecular mechanism of ticagrelor on cerebral ischemia reperfusion injury in rats

    Directory of Open Access Journals (Sweden)

    Gui-Fa Chen

    2017-06-01

    Full Text Available Objective: To study the influence and molecular mechanism of ticagrelor on cerebral ischemia reperfusion injury in rats. Methods: SD rats were selected as experimental animals and divided into control group, model group, ticagrelor group and clopidogrel group, cerebral ischemic reperfusion injury models were made, then ticagrelor group were given intragastric administration of 150 mg ticagrelor, clopidogrel group were given intragastric administration of 90 mg clopidogrel. 1 week after intervention, the brain water content as well as the contents of oxidative stress molecules and inflammatory factors were measured. Results: Water content in brain, MDA, Ox-LDL, NF-kB, TNF-α, IL-1β and IL-6 contents in brain tissue as well as TNF-α, IL-1β and IL-6 contents in serum of model group were significantly higher than those of control group while SOD, GSH-Px and Prdx6 contents in brain tissue were significantly lower than those of control group; water content in brain, MDA, Ox-LDL, NFkB, TNF-α, IL-1β and IL-6 contents in brain tissue as well as TNF-α, IL-1β and IL-6 contents in serum of ticagrelor group and clopidogrel group were significantly lower than those of model group while SOD, GSH-Px and Prdx6 contents in brain tissue were significantly higher than those of model group; water content in brain, MDA, Ox-LDL, NF-kB, TNF-α, IL-1β and IL-6 contents in brain tissue as well as TNF-α, IL-1β and IL-6 contents in serum of ticagrelor group were significantly lower than those of clopidogrel group while SOD, GSHPx and Prdx6 contents in brain tissue were significantly higher than those of clopidogrel group. Conclusion: Ticagrelor can be more effective in inhibiting oxidative stress response and inflammatory response, and reducing the cerebral ischemia reperfusion injury than clopidogrel.

  8. Plato: from Socrates to Pre-Socratics?

    Directory of Open Access Journals (Sweden)

    YU. SHICHALIN

    2015-04-01

    Full Text Available The traditional view on the chronology of the Corpus Platonicum (CP texts turns out to be anachronistic from several, especially formal and historical, points of view. From the formal point of view all the CP texts can be divided into speeches, framed dialogues and dialogues in dramatic form; there are serious reasons for correlating these groups of dialogues with different chronological periods. Historically, to view Plato’s works as modern philosophical and scholarly literature is incorrect; instead, it would seem expedient to correlate the three groups of dialogues mentioned with their changing audiences for which Plato wrote before the establishment of the Academy, during the first stage of its existence (before the second trip to Sicily and in the later period. The evolution of Plato’s philosophy is to be correlated with the evolution of the school created by him. Lack of attention to these methods can lead to incorrect assumptions concerning Plato’s evolution which found their way, among others, into the book “Plato and the Post-Socratic Dialogue” by Prof. Ch. Kahn where he speaks of a transition from Socratic to Pre-Socratic problems in Plato’s works; the book is critically examined by the author of the present article.

  9. A scientific approach to Plato's Atlantis

    Directory of Open Access Journals (Sweden)

    Massimo Rapisarda

    2015-09-01

    Full Text Available The myth of Atlantis is hard to die. This attempt to use scientific evidence to give it the final smash ends up with the doubt that it might not be totally unsubstantiated. The time of the supposed existence of Atlantis (around twelve thousand years ago was, in fact, characterized by technological revolutions, acknowledged by archaeology, and abrupt climate changes, documented by geology. In principle, it cannot therefore be ruled out that some of those dramatic events left a memory, later used by Plato as a basis for its tale. The climate changes involved the majority of the northern hemisphere, thus all the ancient civilizations (Egyptian, Mesopotamian, Indian and Chinese could have preserved reminiscence, but it is clear that the events occurring closer to Greece would have been more accessible to Plato. Among the Mediterranean sites that experienced the cataclysms of the beginning of the Holocene, a good candidate to host a primordial civilization might have been the archipelago then existing in the Strait of Sicily, a natural maritime link between Tunisia and Italy, prized by the presence of an obsidian source at Pantelleria. Eleven thousand five hundred years ago, a sudden sea level rise erased the archipelago, submerging the possible settlements, but Pantelleria obsidian ores are still there and could provide a significant clue. In fact, the potential discovery of artefacts, originating from a source now submerged by the sea level rise, would imply that the collection of the mineral took place when it was still emerged, namely at the time of Atlantis. Even if such discovery would not be sufficient to prove the existence of the mythical island, it would be enough to shake up the timeline of the human occupation in the region.

  10. What Plato and Murdoch Think About Love

    Directory of Open Access Journals (Sweden)

    Shadi Shakouri

    2012-07-01

    Full Text Available There are many interpretations of love and lots of scholars write and talk on love; however, what exactly is the meaning of love? Iris Murdoch’s works are an accumulation of emotional relationships and feelings of love. Her great subject is love, both sexual and non-sexual, and her characters are the portrayal of a small group of people caught up in convoluted ties of love and hate, with Eros ruling over them (Cohen 22. Murdoch was one of the most respected British writers and philosophers of the second half of the twentieth century and, of course, the postwar period. In Murdoch’s novels, love is one of the central themes—marriage, as the institution of love, more often binds than frees. Her characters are mainly ego-centric people who struggle to love and are often overwhelmed by the factor of self-obsession, jealousy, ambition, fascination with suffering and charismatic power. They are absolutely ordinary people with a consuming demand for love, and mental and physical exile. Murdoch was inspired by Plato’s ideas in many ways. Like art, here again Plato’s idea of love is more skeptical than Murdoch’s, whereas Murdoch kept it only as a way to the Good, creation, and happiness. Murdoch and Plato saw love more as a Freudian concept, the Eros, the word that comes from the name of the first Greek god of love. Both the philosophers, Plato and Murdoch, believed that this erotic longing and desires revived by Eros can led to a new direction, a way toward virtue and truth. Her protagonist or marginalized characters are usually tackling it with either vulgarity or the heavenly, which results in creation, art or salvation. Murdoch, as a major moral philosopher, usually grasps the chances to encapsulate her moral visions in her works, and created novels that should be counted as meditations on human love and goodness.

  11. Anamnesis and the Silent Narrator in Plato and John

    Directory of Open Access Journals (Sweden)

    George L. Parsenios

    2017-03-01

    Full Text Available The Gospel of John is often compared to the dialogues of Plato by those who connect Johannine theology and Platonic philosophy. The comparison operates on the level of ideas. The present paper does not ignore issues of theology and philosophy but grounds a comparison of John and Plato first and foremost on the literary level. In several key places in John 1, 3, and 14, the Johannine narrator recedes from view and is unexpectedly silent where one would expect a narrator’s comment to organize the conversations and interactions between characters in John. Plato also renders the voice of the narrator silent in a dialogue like the Theaetetus. This paper argues that John and Plato both suppress the narrator’s voice in order to further their anamnetic efforts and to make later generations not only readers but participants in their original conversations.

  12. 1 Plato's Theories of Knowledge and Education: an Examination of ...

    African Journals Online (AJOL)

    Ngozi Ezenwa-Ohaeto

    doing introduced some of the most insightful theories of knowledge that ..... major deductions he makes from that quotation (but does not explain), are: (i). That Plato 'assumes' that there is 'a pre- linguistic realm whose representation either.

  13. Isocrates and Plato on Rhetoric and Rhetorical Education.

    Science.gov (United States)

    Benoit, William L.

    1991-01-01

    Compares the views of Isocrates and Plato on rhetoric and rhetorical education. Elucidates their criticisms of the sophists, their general assumptions about the nature and function of rhetoric, and their views on rhetorical education. (PRA)

  14. Rationality and Motivation: Moral Psychology in Plato's Socratic Dialogues

    OpenAIRE

    Neiders, Ivars

    2011-01-01

    "Rationality and Motivation: Moral Psychology in Plato's Socratic Dialogues" Annotation The dissertation "Rationality and Motivation: Moral Psychology in Plato's Socratic Dialogues" is a philosophical study of Socratic views in moral psychology. Particular attention is paid to what the author calls (1) Doxastic competence and (2) Orectic competence. It is argued that according to Socrates these two different epistemic relations are important aspects of our self-understanding. The doxast...

  15. Inverse agonism at the P2Y12 receptor and ENT1 transporter blockade contribute to platelet inhibition by ticagrelor.

    Science.gov (United States)

    Aungraheeta, Riyaad; Conibear, Alexandra; Butler, Mark; Kelly, Eamonn; Nylander, Sven; Mumford, Andrew; Mundell, Stuart J

    2016-12-08

    Ticagrelor is a potent antagonist of the P2Y 12 receptor (P2Y 12 R) and consequently an inhibitor of platelet activity effective in the treatment of atherothrombosis. Here, we sought to further characterize its molecular mechanism of action. Initial studies showed that ticagrelor promoted a greater inhibition of adenosine 5'-diphosphate (ADP)-induced Ca 2+ release in washed platelets vs other P2Y 12 R antagonists. This additional effect of ticagrelor beyond P2Y 12 R antagonism was in part as a consequence of ticagrelor inhibiting the equilibrative nucleoside transporter 1 (ENT1) on platelets, leading to accumulation of extracellular adenosine and activation of G s -coupled adenosine A 2A receptors. This contributed to an increase in basal cyclic adenosine monophosphate (cAMP) and vasodilator-stimulated phosphoprotein phosphorylation (VASP-P). In addition, ticagrelor increased platelet cAMP and VASP-P in the absence of ADP in an adenosine receptor-independent manner. We hypothesized that this increase originated from a direct effect on basal agonist-independent P2Y 12 R signaling, and this was validated in 1321N1 cells stably transfected with human P2Y 12 R. In these cells, ticagrelor blocked the constitutive agonist-independent activity of the P2Y 12 R, limiting basal G i -coupled signaling and thereby increasing cAMP levels. These data suggest that ticagrelor has the pharmacological profile of an inverse agonist. Based on our results showing insurmountable inhibition of ADP-induced Ca 2+ release and forskolin-induced cAMP, the mode of antagonism of ticagrelor also appears noncompetitive, at least functionally. In summary, our studies describe 2 novel modes of action of ticagrelor, inhibition of platelet ENT1 and inverse agonism at the P2Y 12 R that contribute to its effective inhibition of platelet activation. © 2016 by The American Society of Hematology.

  16. Spectroscopic study on flavonoid–drug interactions: Competitive binding for human serum albumin between three flavonoid compounds and ticagrelor, a new antiplatelet drug

    Energy Technology Data Exchange (ETDEWEB)

    Liu, Bing-Mi, E-mail: liubingmi@163.com [Department of Pharmacy, Liaoning University, Shenyang 110036 (China); Zhang, Jun [Department of Pharmacy, Liaoning University, Shenyang 110036 (China); Bai, Chong-Liang [Centre for Molecular Science and Engineering, Northeastern University, Shenyang 110819 (China); Wang, Xin; Qiu, Xin-Zhi; Wang, Xiao-Li; Ji, Hui [Department of Pharmacy, Liaoning University, Shenyang 110036 (China); Liu, Bin, E-mail: liubinzehao@163.com [Department of Pharmacy, Liaoning University, Shenyang 110036 (China)

    2015-12-15

    The effects of three kinds of flavonoids, quercetin, rutin and baicalin, on the binding of ticagrelor to human serum albumin (HSA) were systematically investigated using fluorescence, UV–vis absorption and circular dichroism (CD) spectroscopic techniques. The results indicated that ticagrelor strongly quenched the HSA fluorescence by the style of static quenching and non-radiation energy transferring as a result of the HSA–ticagrelor complex formation, while the presence of flavonoids could not change the quenching mechanism. Ticagrelor could spontaneously bind in site I on HSA with high affinity, and this binding process was mainly driven by both hydrophobic forces and hydrogen bonding. The significantly decreased binding affinity and the unchanged binding mode and distance between ticagrelor and HSA indicated that that flavonoids could compete against ticagrelor in site I, and baicalin was the most effective competitor. The conformation investigation of HSA further confirmed the flavonoid/ticagrelor competitive binding mechanism. - Highlights: • Ticagrelor could spontaneously bind in subdomain IIA (site I) on HSA with high affinity. • The presence of flavonoids could not change the quenching mechanism. • The presence of flavonoids significantly decreased the binding affinity of ticagrelor with HSA. • Flavonoids could compete against ticagrelor in site I. • Baicalin was the most effective competitor among the three flavonoids.

  17. Spectroscopic study on flavonoid–drug interactions: Competitive binding for human serum albumin between three flavonoid compounds and ticagrelor, a new antiplatelet drug

    International Nuclear Information System (INIS)

    Liu, Bing-Mi; Zhang, Jun; Bai, Chong-Liang; Wang, Xin; Qiu, Xin-Zhi; Wang, Xiao-Li; Ji, Hui; Liu, Bin

    2015-01-01

    The effects of three kinds of flavonoids, quercetin, rutin and baicalin, on the binding of ticagrelor to human serum albumin (HSA) were systematically investigated using fluorescence, UV–vis absorption and circular dichroism (CD) spectroscopic techniques. The results indicated that ticagrelor strongly quenched the HSA fluorescence by the style of static quenching and non-radiation energy transferring as a result of the HSA–ticagrelor complex formation, while the presence of flavonoids could not change the quenching mechanism. Ticagrelor could spontaneously bind in site I on HSA with high affinity, and this binding process was mainly driven by both hydrophobic forces and hydrogen bonding. The significantly decreased binding affinity and the unchanged binding mode and distance between ticagrelor and HSA indicated that that flavonoids could compete against ticagrelor in site I, and baicalin was the most effective competitor. The conformation investigation of HSA further confirmed the flavonoid/ticagrelor competitive binding mechanism. - Highlights: • Ticagrelor could spontaneously bind in subdomain IIA (site I) on HSA with high affinity. • The presence of flavonoids could not change the quenching mechanism. • The presence of flavonoids significantly decreased the binding affinity of ticagrelor with HSA. • Flavonoids could compete against ticagrelor in site I. • Baicalin was the most effective competitor among the three flavonoids.

  18. Potential Additive Effects of Ticagrelor, Ivabradine, and Carvedilol on Sinus Node

    Directory of Open Access Journals (Sweden)

    Luigi Di Serafino

    2014-01-01

    Full Text Available A 51-year-old male patient presented to the emergency room with an anterior ST-elevation myocardial infarction. After a loading dose of both ticagrelor and aspirin, the patient underwent primary-PCI on the left anterior descending coronary artery with stent implantation. After successful revascularization, medical therapy included beta-blockers, statins, and angiotensin II receptor antagonists. Two days later, ivabradine was also administered in order to reduce heart rate at target, but the patient developed a severe symptomatic bradycardia and sinus arrest, even requiring administration of both atropine and adrenaline. Ivabradine and ticagrelor have been then suspended and this latter changed with prasugrel. Any other similar event was not reported during the following days. This clinical case raised concerns about the safety of the combination of beta-blockers and ivabradine in patients treated with ticagrelor, particularly during the acute phase of an acute coronary syndrome. These two latter drugs, in particular, might interact with the same receptor. In fact, ivabradine directly modulates the If-channel which is also modulated by the cyclic adenosine monophosphate levels. These latter have been shown to increase after ticagrelor assumption via inhibition of adenosine uptake by erythrocytes. Further studies are warrant to better clarify the safety of this association.

  19. Plato, Nightingale, and Nursing: Can You Hear Me Now?

    Science.gov (United States)

    Arnone, Jacqueline Michele; Fitzsimons, Virginia

    2015-10-01

    A historical perspective on how the writings of Plato influenced Florence Nightingale in the formation of nursing as a respected profession for women. Comparing Nightingale's life and legacy to Platonic philosophy demonstrates how philosophy continues to speak to the profession of nursing practice as guardians of society in the 21st century. A review of the literature using EBSCO, SAGEpub, MEDLINE, and CINAHL databases and hand searches of literature were initiated for the years 1990-2014 using the terms "Plato," "Nightingale," and "nursing" restricted to English. Florence Nightingale, known as the mother of modern-day nursing, embodied her life and work after the philosophic tenets of Plato. Plato's Allegory of the Cave influenced Nightingale's attitudes with regard to the value of education, knowledge of the good, and the importance of imparting learned knowledge to others. Plato's work spoke of educating both men and women to seek the truth, affording both sexes to become competent as future leaders in the role of guardians to society. Nightingale's emphasis of education for women as a conduit for their usefulness to society mirrored Plato's philosophy. Over 100 years after her death, the impact Florence Nightingale still has on professional nursing practice remains. Scholarship in nursing education today is infused with a liberal arts background in philosophy, ethics, and the sciences. Nightingale's holistic concepts of person, health, and environment in the practice of nursing coalesced with her statistical analyses in validating nursing actions foreshadowed the development of universal nursing knowledge and language base and meta-paradigm concepts in nursing. Further classification and categorization of Nightingale's concepts of assessing, implementing, and evaluating delivery of care became the linguistic precursors for the identification of nursing process, nursing actions, and nursing diagnoses. Plato's and Nightingale's holistic, scientific, and

  20. Ticagrelor, but not clopidogrel active metabolite, displays antithrombotic properties in the left atrial endocardium.

    Science.gov (United States)

    Reiner, Martin F; Breitenstein, Alexander; Holy, Erik W; Glanzmann, Martina; Amstalden, Heidi; Stämpfli, Simon F; Bonetti, Nicole R; Falk, Volkmar; Keller, Stephan; Savarese, Gianluigi; Benussi, Stefano; Maisano, Francesco; Lüscher, Thomas F; Beer, Jürg H; Steffel, Jan; Camici, Giovanni G

    2017-03-21

    Oral anticoagulation is considered standard therapy for stroke prevention in atrial fibrillation (AF). Endocardial activation triggers expression of pro-thrombotic mediators including tissue factor (TF) and plasminogen activator inhibitor-1 (PAI-1), and contributes to thrombus formation in the left atrial appendage (LAA) of AF patients. Recently, pleiotropic effects of specific P2Y12 receptor antagonists were demonstrated; however, whether these drugs possess antithrombotic effects on LAA endocardial cells currently remains unknown. LAA were obtained from 14 patients with known AF undergoing elective cardiac surgery including LAA removal at the University Hospital Zurich. LAA endocardial cells were isolated and pre-incubated with ticagrelor (10-7, 10-6, 10-5M) or clopidogrel active metabolite (CAM) (1.5 × 10-8, 1.5 × 10-7, 1.5 × 10-6 M) before stimulation with tumour necrosis factor-alpha (TNF-α) (10 ng/mL). Finally, TF and PAI-1 expression and activity were analysed. Ticagrelor, unlike CAM, concentration dependently decreased TNF-α-induced TF expression and TF activity in LAA endocardial cells. Further, ticagrelor, but not CAM reduced PAI-1 expression and enzyme activity in TNF-α-stimulated LAA endocardial cells. In contrast, TF pathway inhibitor (TFPI) remained unaffected by both dugs. Ticagrelor, but not CAM, reduces expression and activity of TF and PAI-1 in LAA endocardial cells isolated from patients with AF, indicating possible local antithrombotic effects. Such pleiotropic properties of ticagrelor may contribute to a reduction in thromboembolic complications in patients with AF. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

  1. Why Did Socrates Deny That He Was a Teacher? Locating Socrates among the New Educators and the Traditional Education in Plato's "Apology of Socrates"

    Science.gov (United States)

    Mintz, Avi I.

    2014-01-01

    Plato's "Apology of Socrates" contains a spirited account of Socrates' relationship with the city of Athens and its citizens. As Socrates stands on trial for corrupting the youth, surprisingly, he does not defend the substance and the methods of his teaching. Instead, he simply denies that he is a teacher. Many scholars have…

  2. Eugenics concept: from Plato to present.

    Science.gov (United States)

    Güvercin, C H; Arda, B

    2008-01-01

    All prospective studies and purposes to improve cure and create a race that would be exempt of various diseases and disabilities are generally defined as eugenic procedures. They aim to create the "perfect" and "higher" human being by eliminating the "unhealthy" prospective persons. All of the supporting actions taken in order to enable the desired properties are called positive eugenic actions; the elimination of undesired properties are defined as negative eugenics. In addition, if such applications and approaches target the public as a whole, they are defined as macro-eugenics. On the other hand, if they only aim at individuals and/or families, they are called micro-eugenics. As generally acknowledged, Galton re-introduced eugenic proposals, but their roots stretch as far back as Plato. Eugenic thoughts and developments were widely accepted in many different countries beginning with the end of the 19th to the first half of the 20th centuries. Initially, the view of negative eugenics that included compulsory sterilizations of handicapped, diseased and "lower" classes, resulted in tens of thousands being exterminated especially in the period of Nazi Germany. In the 1930s, the type of micro positive eugenics movement found a place within the pro-natalist policies of a number of countries. However, it was unsuccessful since the policy was not able to become effective enough and totally disappeared in the 1960s. It was no longer a fashionable movement and left a deep impression on public opinion after the long years of war. However, developments in genetics and its related fields have now enabled eugenic thoughts to reappear under the spotlight and this is creating new moral dilemmas from an ethical perspective.

  3. Plato, Aristotle and the phytagorean influence on Plutarch's De Musica

    Directory of Open Access Journals (Sweden)

    Roosevelt Rocha

    2012-07-01

    Full Text Available In his treatise On Music, Plutarch cites and discusses excerpts from works of Plato and Aristotle in which these authors deal with issues relevant to the harmonic theory. In these passages, we see that the sources used by Plutarch have a strong influence of the Pythagorean school, under which the study of musical scales was developed focusing on the mathematical relationships that exist between the notes and intervals. This indicates that Plutarch or not directly read the texts of Plato and Aristotle, or read, but using some other source, a commentator of Pythagorean extraction, who we can not identify.

  4. Plato's Cosmic Theology: A Rationale for a Polytheistic Astrology?

    Science.gov (United States)

    Henriques, André

    2015-05-01

    Plato's cosmology influenced classical astronomy and religion, but was in turn influenced by the polytheistic context of its time. Throughout his texts, including the cosmological treatise Timaeus, and the discussions on the soul in the Phaedrus, Plato (c.428-c.348 BC) established what can be generalised as Platonic cosmological thought. An understanding of the philosophical and mythical levels of Platonic thought can provide a rationale for polytheistic and astrological worldviews, pointing to some cosmological continuity, alongside major shifts, from ancient Greek religion to the astrological thought of ancient astronomers such as Claudius Ptolemy.

  5. Expected asteroseismic performances with the space project PLATO

    Directory of Open Access Journals (Sweden)

    Goupil Mariejo

    2017-01-01

    Full Text Available The PLATO (PLAnetary Transits and Oscillations of star space project will observe about fifty percents of the sky with the main purpose of detecting, confirming and characterizing transiting exoplanets of (superEarth sizes in the habitable zone of solar-like stars. Determining masses, radii and ages of exoplanets require the knowledge the masses, radii and ages of the host stars. We give a brief presentation of the main features of the mission. We then discuss some expected seismic performances of PLATO for characterizing bright solar-like stars, focusing on the challenging determination of accurate/precise stellar ages.

  6. Spontaneous subdural hematoma and antiplatelet therapy: Does efficacy of Ticagrelor come with added risk?

    Directory of Open Access Journals (Sweden)

    Pattanagere Manjunatha Suryanarayana Sharma

    2015-12-01

    Full Text Available Antiplatelet therapy has established clinical benefit on cardiovascular outcome and has reduced the rates of re-infarction/in stent thrombosis following percutaneous coronary intervention in acute coronary syndromes. Major bleeding episodes can occur with antiplatelet therapy and intracranial hemorrhage (ICH is one of the most feared complications resulting in significant morbidity and mortality. Identification of high risk groups and judicious use of antiplatelet therapy reduces the bleeding risk. Ticagrelor is a newer P2Y12 receptor antagonist with established clinical benefit. However, risks of having an ICH with these newer molecules cannot be ignored. Here, we report a case of spontaneous acute subdural hematoma developing in a patient on antiplatelet therapy with aspirin and ticagrelor. Early recognition, discontinuation of the medication and appropriate management resulted in resolution of hematoma and good clinical outcome. Authors have reviewed the antithrombotic drugs and their tendencies in causing intracranial bleeds from a neurophysicians perspective.

  7. The necessity of dialectics according to Plato and Adorno

    DEFF Research Database (Denmark)

    Olsen, Anne-Marie Eggert

    2009-01-01

    The paper deals with the notion of philosophy as, on the one hand, an academic or scientific discipline and, on the other, something perhaps superior to the disciplines and in any case dealing with what is not a 'disciplinary' matter. Through an interpretation of Plato's concept of dialectics and...

  8. Plato and Play: Taking Education Seriously in Ancient Greece

    Science.gov (United States)

    D'Angour, Armand

    2013-01-01

    In this article, the author outlines Plato's notions of play in ancient Greek culture and shows how the philosopher's views on play can be best appreciated against the background of shifting meanings and evaluations of play in classical Greece. Play--in various forms such as word play, ritual, and music--proved central to the development of…

  9. Plato, Freud and Marx on Human Nature: A Comparative Analysis ...

    African Journals Online (AJOL)

    This paper examines the conceptions of human nature by Plato, Sigmund Freud and Karl Marx, with a view to revealing and explaining the convergence and divergence between these conceptions. It shows that agreement or disagreement on the distinguishing characteristics of human individuals can be situated on ...

  10. Three Misunderstandings of Plato's Theory of Moral Education

    Science.gov (United States)

    Jonas, Mark E.

    2016-01-01

    In this essay, Mark Jonas argues that there are three broadly held misconceptions of Plato's philosophy that work against his relevance for contemporary moral education. The first is that he is an intellectualist who is concerned only with the cognitive aspect of moral development and does not sufficiently emphasize the affective and conative…

  11. PLATO[R] Achieve Now. What Works Clearinghouse Intervention Report

    Science.gov (United States)

    What Works Clearinghouse, 2010

    2010-01-01

    "PLATO[R] Achieve Now" is a software-based curriculum for the elementary and middle school grades. Instructional content is delivered via the PlayStation Portable (PSP[R]) system, allowing students to access learning materials in various settings. Software-based assessments are used to customize individual instruction, allowing students…

  12. Go Tell Alcibiades: Tragedy, Comedy, and Rhetoric in Plato's "Symposium"

    Science.gov (United States)

    Crick, Nathan; Poulakos, John

    2008-01-01

    Plato's "Symposium" is a significant but neglected part of his elaborate and complex attitude toward rhetoric. Unlike the intellectual discussion of the "Gorgias" or the unscripted conversation of the "Phaedrus," the "Symposium" stages a feast celebrating and driven by the forces of "Eros." A luxuriously stylish performance rather than a rational…

  13. Future development of the PLATO Observatory for Antarctic science

    Science.gov (United States)

    Ashley, Michael C. B.; Bonner, Colin S.; Everett, Jon R.; Lawrence, Jon S.; Luong-Van, Daniel; McDaid, Scott; McLaren, Campbell; Storey, John W. V.

    2010-07-01

    PLATO is a self-contained robotic observatory built into two 10-foot shipping containers. It has been successfully deployed at Dome A on the Antarctic plateau since January 2008, and has accumulated over 730 days of uptime at the time of writing. PLATO provides 0.5{1kW of continuous electrical power for a year from diesel engines running on Jet-A1, supplemented during the summertime with solar panels. One of the 10-foot shipping containers houses the power system and fuel, the other provides a warm environment for instruments. Two Iridium satellite modems allow 45 MB/day of data to be transferred across the internet. Future enhancements to PLATO, currently in development, include a more modular design, using lithium iron-phosphate batteries, higher power output, and a light-weight low-power version for eld deployment from a Twin Otter aircraft. Technologies used in PLATO include a CAN (Controller Area Network) bus, high-reliability PC/104 com- puters, ultracapacitors for starting the engines, and fault-tolerant redundant design.

  14. Evaluation of crushed ticagrelor tablet doses: recovery following crushing and naso-gastric tube passage ex vivo.

    Science.gov (United States)

    Crean, Barry; Finnie, Cindy; Crosby, Anna

    2013-06-01

    Orally available ticagrelor in combination with low-dose aspirin (75-100 mg/day) is indicated for adult patients with acute coronary syndromes. However, patients with swallowing difficulties may be unable to consume the currently available 90-mg tablet. It is hypothesized that ticagrelor could be given to this patient cohort as a crushed dose administered either orally or via a naso-gastric (NG) tube. To investigate the potential use of crushed ticagrelor tablets (90- and 180-mg doses) for oral dose or NG tube administration. Ticagrelor tablets (90 or 180 mg [two 90-mg tablets]) were prepared to emulate oral and NG tube administration by similar methods. For the oral dose, ticagrelor tablets were crushed using a mortar and pestle and transferred to a dosing cup. 100 mL of water was added to the mortar, stirred, and the contents were transferred to the dosing cup and stirred to form a suspension. At this stage, where the suspension would normally be administered to a patient, it was collected for high performance liquid chromatography (HPLC) analysis. The mortar was then flushed with 100 mL of water, and the contents were again transferred to the dosing cup, stirred, and collected for HPLC analysis. For the NG dose, polyvinylchloride, polyurethane, and silicone size CH10 NG tubes were used. The tablets were crushed using a mortar and pestle, diluted with 50 mL of water, and stirred. At this stage, where the suspension would normally be administered to a patient through an NG tube using a syringe, it was collected for HPLC analysis. The mortar was then flushed with two additional 50 mL aliquots of water and the contents were passed through the NG tube. HPLC analysis examined the recoverability of ticagrelor in each of the dose suspensions and flushes and the stability of the suspension when held in a syringe for up to 2 h. One or two crushed 90-mg ticagrelor tablets, prepared for either oral or NG tube administration, delivers a mean dose of ≥97% of the original

  15. Effects of ticagrelor versus clopidogrel on platelet function in fibrinolytic-treated STEMI patients undergoing early PCI.

    Science.gov (United States)

    Dehghani, Payam; Lavoie, Andrea; Lavi, Shahar; Crawford, Jennifer J; Harenberg, Sebastian; Zimmermann, Rodney H; Booker, Jeff; Kelly, Sheila; Cantor, Warren J; Mehta, Shamir R; Bagai, Akshay; Goodman, Shaun G; Cheema, Asim N

    2017-10-01

    Patients undergoing PCI early after fibrinolytic therapy are at high risk for both thrombotic and bleeding complications. We sought to assess the pharmacodynamic effects of ticagrelor versus clopidogrel in the fibrinolytic-treated STEMI patients undergoing early PCI. Patients undergoing PCI within 24 hours of tenecteplase (TNK), aspirin, and clopidogrel for STEMI were randomized to receive additional clopidogrel 300 mg followed by 75 mg daily or ticagrelor 180 mg followed by 90 mg twice daily. The platelet reactivity units (PRU) were measured with the VerifyNow Assay before study drug administration (baseline) at 4 and 24 hours post-PCI. The primary end point was PRU ≤208 at 4 hours. A total of 140 patients (74 in ticagrelor and 66 in clopidogrel group) were enrolled. The mean PRU values at baseline were similar for the 2 groups (257.8±52.9 vs 259.5±56.7, P=.85, respectively). Post-PCI, patients on ticagrelor, compared to those on clopidogrel, had significantly lower PRU at 4 hours (78.7±88 vs 193.6±86.5, respectively, PPCI frequently had PRU >208. In this high-risk population, ticagrelor provides more prompt and potent platelet inhibition compared with clopidogrel (Funded by Astra Zeneca; NCT01930591, https://clinicaltrials.gov/ct2/show/NCT01930591). Copyright © 2017 Elsevier Inc. All rights reserved.

  16. Effect of Pre-Hospital Ticagrelor During the First 24 h After Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction

    DEFF Research Database (Denmark)

    Montalescot, Gilles; van 't Hof, Arnoud W; Bolognese, Leonardo

    2016-01-01

    OBJECTIVES: The aim of this landmark exploratory analysis, ATLANTIC-H(24), was to evaluate the effects of pre-hospital ticagrelor during the first 24 h after primary percutaneous coronary intervention (PCI) in the ATLANTIC (Administration of Ticagrelor in the cath Lab or in the Ambulance for New ST...... hypothesized that the effect of pre-hospital ticagrelor may not have manifested until after PCI due to the rapid transfer time (31 min). METHODS: The ATLANTIC-H(24) analysis included 1,629 patients who underwent PCI, evaluating platelet reactivity, Thrombolysis In Myocardial Infarction flow grade 3, ≥ 70% ST...... except death (1.1% vs. 0.2%; p = 0.048) favored pre-hospital ticagrelor, with no differences in bleeding events. CONCLUSIONS: The effects of pre-hospital ticagrelor became apparent after PCI, with numerical differences in platelet reactivity and immediate post-PCI reperfusion, associated with reductions...

  17. THE JOURNEY OF TRUTH: FROM PLATO TO ZOLA

    Directory of Open Access Journals (Sweden)

    Ribut Basuki

    1999-01-01

    Full Text Available Western theater theory and criticism is generally considered to be set forth by the Greeks. Plato was "the first theater critic" with his negative comments about theater owing to his idealistic views about "the truth." Then came Aristotle who used a different viewpoint from that of Plato, saying that there is "truth" in theater. However, hostile criticism on theater came back in the Middle Ages, championed by Tertulian before Aristotelian theory was revived by the neo-classicists such as Scaliger and Castelvetro. Theater theory and criticism discourse was then made more alive by the romanticists who disagreed with the neo-classicists' rigid rules on theater. As the influence of science became dominant in the theater world, naturalism and realism emerged and became the mainstream of theater theory and criticism until well into the twentieth century.

  18. Approach to the problem of motion in Plato

    Directory of Open Access Journals (Sweden)

    Ignacio García Peña

    2013-07-01

    Full Text Available Since the first philosophers began to reflect about the idea of nature, the problem of motion became a crucial topic in their discussions. The entire pre-Socratic tradition was gathered by Plato, whose reflections are often triggered by fragments of Parmenides and Heraclitus. The Athenian philosopher analyzed motion in relation to the visible and intelligible regions that he distinguishes in the sphere of reality, as well as the fine line that links it to the soul

  19. Plato and Aristotle on the Problem of Quality

    OpenAIRE

    Santa Cruz, María Isabel

    2013-01-01

    This paper purports toshow that it is not necessary to read the early Platonic dialogues starting from the "classic" theory of Forms. It argues, instead, that it is possibleto analyze them and, above all, to explain the use of the vocabulary of "presence" starting from the more general and prior possibility of distinguishing a subject from its accidental predicates, especially quality. The relation of "present in" or "being in" to which Plato recurs. is inherited by Aristotle. The distinction...

  20. Effect of loading-dose ticagrelor on coronary blood flow, left ventricular remodeling and myocardial enzyme spectrum in patients with acute myocardial infarction after interventional therapy

    Directory of Open Access Journals (Sweden)

    Xiao-Rui Xie

    2016-12-01

    Full Text Available Objective: To study the effect of loading-dose ticagrelor on coronary blood flow, left ventricular remodeling and myocardial enzyme spectrum in patients with acute myocardial infarction after interventional therapy. Methods: A total of 86 patients with acute myocardial infarction who received emergency PCI in our hospital between May 2013 and May 2016 were selected and randomly divided into two groups, ticagrelor group received perioperative ticagrelor therapy and clopidogrel group received perioperative clopidogrel therapy. After PCI, coronary blood flow reperfusion was evaluated, serum myocardial remodeling indexes and myocardial enzymes were determined, and cardiac color Doppler ultrasonography was conducted to determine the cardiac function indexes. Results: TIMI grading and TMPG grading of ticagrelor group after PCI were significantly higher than those of clopidogrel group; serum MMP9, BNP, CITP, PICP, PIIINP, CK, CK-MB, cTnI and cTnT content of ticagrelor group 24h after operation were significantly lower than those of clopidogrel group; LVEDD, LVSED and LVMI of ticagrelor group 2 weeks after operation were significantly lower than those of clopidogrel group while LVEF was significantly higher than that of clopidogrel group. Conclusion: Peri-PCI loading-dose ticagrelor can improve coronary blood perfusion and reduce ventricular remodeling and myocardial injury in patients with acute myocardial infarction.

  1. Discourse, Dialectic and Intrapersonal Rhetoric: A Reinterpretation of Plato's Rhetorical Theory.

    Science.gov (United States)

    Hikins, James W.

    The idea that rhetoric might operate in epistemologically significant ways was first presented by Plato. This paper argues that the heart of Plato's conception of epistemic discourse is a recognition of the centrality of intrapersonal rhetoric. Through a careful study of Platonic writing, particularly the "Phaedrus," three principal…

  2. Worldly and Otherworldly Virtue: Likeness to God as Educational Ideal in Plato, Plotinus, and Today

    Science.gov (United States)

    Zovko, Marie-Élise

    2018-01-01

    In Plato, 'Becoming like God' constitutes the "telos" of the philosophical life. Our 'likeness to God' is rooted in the relationship of the divine paradeigma to its image established in the generation of the Cosmos. This relationship makes knowledge and virtue possible, and informs Plato's theory of education. Related concepts preexist…

  3. Plato and the Modern American "Right": Agendas, Assumptions, and the Culture of Fear

    Science.gov (United States)

    Ramsey, Paul

    2009-01-01

    This article presents an interpretation of Plato's "Republic" that has many striking similarities to the social agenda of modern educational conservatives in the United States, which is particularly timely because George W. Bush's administration is, at this writing, coming to an end. Plato's ideal city is best seen as one that promoted an…

  4. Reversing Plato’s Anti-Democratism: Castoriadis’ “Quirky” Plato

    Directory of Open Access Journals (Sweden)

    Hamblet, Wendy C.

    2008-12-01

    Full Text Available This paper considers the conflicting "loves" of Cornelius Castoriadis--his love for the ancients, and especially Plato, and for the common person of the demos. A detailed study of Castoriadis' analysis of Plato's Statesman exposes that Castoriadis attempts to resolve the paradox by rereading Plato as a radical democrat. I argue that this unorthodox reading is at best "quirky, " (a charge Castoriadis levels at Plato at worst a groundless sophism. However, I conjecture that Castoriadis' reading may not constitute a serious attempt to describe a Platonic politics, so much as a prescriptive reading of what otherwise might have been, given certain strands of political generosity evident elsewhere in Plato's corpus.

  5. Pre-hospital ticagrelor in ST-segment elevation myocardial infarction in the French ATLANTIC population

    DEFF Research Database (Denmark)

    Cayla, Guillaume; Lapostolle, Frederic; Ecollan, Patrick

    2017-01-01

    BACKGROUND: ATLANTIC was a randomized study comparing pre- and in-hospital treatment with a ticagrelor loading dose (LD) in ongoing ST-segment elevation myocardial infarction (STEMI). We sought to compare patient characteristics and clinical outcomes in France with other countries participating...... in ATLANTIC. METHODS: The population comprised 1862 patients, 660 (35.4%) from France and 1202 from 12 other countries. The main endpoints were reperfusion (≥70% ST-segment elevation resolution) and TIMI flow grade 3 before (co-primary endpoints) and after percutaneous coronary intervention (PCI). Other...... endpoints included a composite ischaemic endpoint (death/myocardial infarction/stroke/urgent revascularization/definite stent thrombosis) and bleeding events at 30days. RESULTS: In France, median times from first LD to angiography and between first and second LDs were 49 and 35min, respectively, and were...

  6. Contemporary use of ticagrelor in patients with acute coronary syndrome: insights from Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART).

    Science.gov (United States)

    Sahlén, Anders; Varenhorst, Christoph; Lagerqvist, Bo; Renlund, Henrik; Wallentin, Lars; James, Stefan K; Jernberg, Tomas

    2016-01-01

    The platelet inhibitor ticagrelor is strongly recommended during 12 months post-acute coronary syndrome (ACS) in European guidelines. We analysed clinical characteristics of patients given ticagrelor for ACS in the real world. We studied the use of ticagrelor in patients admitted for ACS in Sweden between 1 January 2012 and 31 December 2013 who were enrolled in the Swedish Web system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART). Clinical characteristics were investigated for patients prescribed ticagrelor at discharge as well as for patients undergoing percutaneous coronary intervention who were prescribed ticagrelor. Independent factors associated with selecting ticagrelor were analysed in logistic regression. We found that 44.0% (n = 12 601) out of a total of 28 639 patients had been prescribed ticagrelor at discharge. After adjusting for age and sex, prior cardiovascular disease was less common in patients discharged on ticagrelor (myocardial infarction, ischaemic stroke, and peripheral vascular disease; P for all <0.001). The risk of death as predicted by GRACE score and the risk of major bleeding as predicted by CRUSADE score were both lower in ticagrelor-treated patients vs. others (median 99 vs. 126 and median 23 vs. 25, respectively; P for both < 0.001). The intended treatment duration at discharge was 12 months in 82.5% of patients and <12 months in 9.3%. Ticagrelor is preferentially being used in patients at lower risk. A minority of patients are recommended ticagrelor during <12 months. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  7. The reversible P2Y12 antagonist ACT-246475 causes significantly less blood loss than ticagrelor at equivalent antithrombotic efficacy in rat.

    Science.gov (United States)

    Rey, Markus; Kramberg, Markus; Hess, Patrick; Morrison, Keith; Ernst, Roland; Haag, Franck; Weber, Edgar; Clozel, Martine; Baumann, Martine; Caroff, Eva; Hubler, Francis; Riederer, Markus A; Steiner, Beat

    2017-10-01

    The P2Y 12 receptor is a validated target for prevention of major adverse cardiovascular events in patients with acute coronary syndrome. The aim of this study was to compare two direct-acting, reversible P2Y 12 antagonists, ACT-246475 and ticagrelor, in a rat thrombosis model by simultaneous quantification of their antithrombotic efficacy and surgery-induced blood loss. Blood flow velocity was assessed in the carotid artery after FeCl 3 -induced thrombus formation using a Doppler flow probe. At the same time, blood loss after surgical wounding of the spleen was quantified. Continuous infusions of ACT-246475 and ticagrelor prevented the injury-induced reduction of blood flow in a dose-dependent manner. High doses of both antagonists normalized blood flow and completely abolished thrombus formation as confirmed by histology. Intermediate doses restored baseline blood flow to ≥65%. However, ACT-246475 caused significantly less increase of blood loss than ticagrelor; the difference in blood loss was 2.6-fold (P ACT-246475 and ticagrelor on vascular tone. At concentrations needed to achieve maximal antithrombotic efficacy, ticagrelor compared with ACT-246475 significantly increased carotid blood flow velocity in vivo (P = 0.003), induced vasorelaxation of precontracted rat femoral arteries, and inhibited contraction of femoral artery induced by electrical field stimulation or by phenylephrine. Overall, ACT-246475 showed a significantly wider therapeutic window than ticagrelor. The absence of vasodilatory effects due to high selectivity of ACT-246475 for P2Y 12 provides potential arguments for the observed safety advantage of ACT-246475 over ticagrelor. © 2017 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics.

  8. Impact of ticagrelor on P2Y1 and P2Y12 localization and on cholesterol levels in platelet plasma membrane.

    Science.gov (United States)

    Rabani, Vahideh; Montange, Damien; Meneveau, Nicolas; Davani, Siamak

    2017-10-11

    Ticagrelor is an antiplatelet agent that inhibits platelet activation via P2Y12 antagonism. There are several studies showing that P2Y12 needs lipid rafts to be activated, but there are few data about how ticagrelor impacts lipid raft organization. Therefore, we aimed to investigate how ticagrelor could impact the distribution of cholesterol and consequently alter the organization of lipid rafts on platelet plasma membranes. We identified cholesterol-enriched raft fractions in platelet membranes by quantification of their cholesterol levels. Modifications in cholesterol and protein profiles (Flotillin 1, Flotillin 2, CD36, P2Y1, and P2Y12) were studied in platelets stimulated by ADP, treated by ticagrelor, or both. In ADP-stimulated and ticagrelor-treated groups, we found a decreased level of cholesterol in raft fractions of platelet plasma membrane compared to the control group. In addition, the peak of cholesterol in different experimental groups changed its localization on membrane fractions. In the control group, it was situated on fraction 2, while in ADP-stimulated platelets, it was located in fractions 3 to 5, and in fraction 4 in ticagrelor-treated group. The proteins studied also showed changes in their level of expression and localization in fractions of plasma membrane. Cholesterol levels of plasma membranes have a direct role in the organization of platelet membranes and could be modified by stimulation or drug treatment. Since ticagrelor and ADP both changed lipid composition and protein profile, investigating the lipid and protein composition of platelet membranes is of considerable importance as a focus for further research in anti-platelet management.

  9. Prospects for detecting decreasing exoplanet frequency with main-sequence age using PLATO

    Science.gov (United States)

    Veras, D.; Brown, D. J. A.; Mustill, A. J.; Pollacco, D.

    2017-09-01

    The space mission PLATO will usher in a new era of exoplanetary science by expanding our current inventory of transiting systems and constraining host star ages, which are currently highly uncertain. This capability might allow PLATO to detect changes in planetary system architecture with time, particularly because planetary scattering due to Lagrange instability may be triggered long after the system was formed. Here, we utilize previously published instability time-scale prescriptions to determine PLATO's capability to detect a trend of decreasing planet frequency with age for systems with equal- mass planets. For two-planet systems, our results demonstrate that PLATO may detect a trend for planet masses which are at least as massive as super-Earths. For systems with three or more planets, we link their initial compactness to potentially detectable frequency trends in order to aid future investigations when these populations will be better characterized.

  10. Democratic institutions: the spell of Plato and the return to the classics

    OpenAIRE

    Colen, José

    2012-01-01

    The purpose of this paper, that reflects an ongoing research, is to suggest the usefulness of an analysis of the readings of Karl Popper and Leo Strauss on Plato's political philosophy. Very different as they are, both thinkers saw in the Republic one of the most powerful critics of democracy and built interpretations and polemic arguments by contrast with Plato's arguments. There are currently two arguments questioning liberal or constitutional democracy. The first originates in the social s...

  11. The role of the poet in Plato's ideal cities of Callipolis and Magnesia

    OpenAIRE

    Gerard Naddaf

    2008-01-01

    Plato's attitude toward the poets and poetry has always been a flashpoint of debate, controversy and notoriety, but most scholars have failed to see their central role in the ideal cities of the Republic and the Laws, that is, Callipolis and Magnesia. In this paper, I argue that in neither dialogue does Plato "exile" the poets, but, instead, believes they must, like all citizens, exercise the expertise proper to their profession, allowing them the right to become full-fledged participants in ...

  12. Latin American Clinical Epidemiology Network Series - Paper 8: Ticagrelor was cost-effective vs. clopidogrel in acute coronary syndrome in Chile.

    Science.gov (United States)

    De la Puente, Catherine; Vallejos, Carlos; Bustos, Luis; Zaror, Carlos; Velasquez, Monica; Lanas, Fernando

    2017-06-01

    To evaluate the incremental cost-effectiveness ratio (ICER) of the use of ticagrelor as a substitute for clopidogrel for secondary prevention of acute coronary syndrome in Chile. Cost-effectiveness analysis based on a Markov model: Safety and effectiveness data of ticagrelor were obtained from a systematic review of the literature. Costs are expressed in Chilean pesos (CLP) as of 2013. The evaluation was conducted from the payer standpoint. A probabilistic sensitivity analysis comprising discount rates and national cost variability was done. A budget impact analysis estimated for 2015 was conducted to calculate the total cost for both treatments. The ICER with a discount rate of 6% for ticagrelor vs. clopidogrel was CLP 4,893,126 per quality-adjusted life-year (QALY) gained (=9,689 US$). In the budget impact analysis for the baseline scenario, considering 100% of treatment, coverage, and adherence, ticagrelor represented an additional cost of CLP 5,233,854,272, for 979 QALYs gained compared with clopidogrel. Ticagrelor is cost-effective in comparison with clopidogrel for the secondary prevention of acute coronary syndrome. These findings are similar to those reported in other international cost-effectiveness studies. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Plato: A localised orbital based density functional theory code

    Science.gov (United States)

    Kenny, S. D.; Horsfield, A. P.

    2009-12-01

    The Plato package allows both orthogonal and non-orthogonal tight-binding as well as density functional theory (DFT) calculations to be performed within a single framework. The package also provides extensive tools for analysing the results of simulations as well as a number of tools for creating input files. The code is based upon the ideas first discussed in Sankey and Niklewski (1989) [1] with extensions to allow high-quality DFT calculations to be performed. DFT calculations can utilise either the local density approximation or the generalised gradient approximation. Basis sets from minimal basis through to ones containing multiple radial functions per angular momenta and polarisation functions can be used. Illustrations of how the package has been employed are given along with instructions for its utilisation. Program summaryProgram title: Plato Catalogue identifier: AEFC_v1_0 Program summary URL:http://cpc.cs.qub.ac.uk/summaries/AEFC_v1_0.html Program obtainable from: CPC Program Library, Queen's University, Belfast, N. Ireland Licensing provisions: Standard CPC licence, http://cpc.cs.qub.ac.uk/licence/licence.html No. of lines in distributed program, including test data, etc.: 219 974 No. of bytes in distributed program, including test data, etc.: 1 821 493 Distribution format: tar.gz Programming language: C/MPI and PERL Computer: Apple Macintosh, PC, Unix machines Operating system: Unix, Linux and Mac OS X Has the code been vectorised or parallelised?: Yes, up to 256 processors tested RAM: Up to 2 Gbytes per processor Classification: 7.3 External routines: LAPACK, BLAS and optionally ScaLAPACK, BLACS, PBLAS, FFTW Nature of problem: Density functional theory study of electronic structure and total energies of molecules, crystals and surfaces. Solution method: Localised orbital based density functional theory. Restrictions: Tight-binding and density functional theory only, no exact exchange. Unusual features: Both atom centred and uniform meshes available

  14. FORMATION OF ANTIQUE RHETORIC: CHRONOLOGY OF RHETORICAL METHODS AND STYLES (PLATO, ARISTOTLE

    Directory of Open Access Journals (Sweden)

    Irina A. Pantelyeyeva

    2013-09-01

    Full Text Available Purpose of the article: to analyze the basic points of philosophical concepts of rhetoric of Plato and Aristotle, to prove that from Plato the rhetoric in the true sense starts being approved, and Aristotle is an ancestor of real theory of speech of the new genre, the new form, the new purposes and tasks of the description of verbal art. Problem statement: development of the ancient principles of rhetorical style’s creating is reached by efforts of outstanding speakers, each of them were differed not only by the ideological sympathies or antipathies, but also by nature of works, the concepts put in their basis. Two Ancient Greek philosophers: Plato and Aristotle are considered as founders of ancient rhetorical science. Methodology. Author has used system method, methods of content and comparative analysis. Scientific novelty is displayed in the received results from the comparative analysis of two concepts of public speech of Plato and Aristotle from a position of philosophical justification of rhetoric’s rules with orientation on ancient "popular" declamation practices. Practical value of article consists in development of insufficiently studied object "Antique declamation discourse" where Plato and Aristotle's two central rhetorical concepts appear as the intermediate stage in development of a declamation discourse of Ancient Greece and, subsequently, and Ancient Rome. Conclusions. The conclusions can be given by the following facts: from Plato the rhetoric in the true sense is approved: true rhetorical art isn’t based only on argument technique, the true rhethor appears as the philosopher. Plato raises the problem of an ambiguity of two opposite rhetorics presented in "Gorgias" and "Phaedrus ". Rhetoric as scientific discipline, as the present theory of speech is first considered by Aristotle. The rhetoric is presented as the science "about speech and about thoughts", about the relation of thinking to the word.

  15. The PLATO Dome A site-testing observatory: Power generation and control systems

    Science.gov (United States)

    Lawrence, J. S.; Ashley, M. C. B.; Hengst, S.; Luong-van, D. M.; Storey, J. W. V.; Yang, H.; Zhou, X.; Zhu, Z.

    2009-06-01

    The atmospheric conditions above Dome A, a currently unmanned location at the highest point on the Antarctic plateau, are uniquely suited to astronomy. For certain types of astronomy Dome A is likely to be the best location on the planet, and this has motivated the development of the Plateau Observatory (PLATO). PLATO was deployed to Dome A in early 2008. It houses a suite of purpose-built site-testing instruments designed to quantify the benefits of Dome A site for astronomy, and science instruments designed to take advantage of the observing conditions. The PLATO power generation and control system is designed to provide continuous power and heat, and a high-reliability command and communications platform for these instruments. PLATO has run and collected data throughout the winter 2008 season completely unattended. Here we present a detailed description of the power generation, power control, thermal management, instrument interface, and communications systems for PLATO, and an overview of the system performance for 2008.

  16. The role of the poet in Plato's ideal cities of Callipolis and Magnesia

    Directory of Open Access Journals (Sweden)

    Gerard Naddaf

    2008-01-01

    Full Text Available Plato's attitude toward the poets and poetry has always been a flashpoint of debate, controversy and notoriety, but most scholars have failed to see their central role in the ideal cities of the Republic and the Laws, that is, Callipolis and Magnesia. In this paper, I argue that in neither dialogue does Plato "exile" the poets, but, instead, believes they must, like all citizens, exercise the expertise proper to their profession, allowing them the right to become full-fledged participants in the productive class. Moreover, attention to certain details reveals that Plato harnesses both positive and negative factors in poetry to bring his ideal cities closer to a practical realization. The status of the poet and his craft in this context has rarely to my knowledge been addressed.

  17. Plato's Critique of Rhetoric in the "Gorgias" (447a-466a): Epistemology, Methodology, and the Lyotardian Differend.

    Science.gov (United States)

    McComiskey, Bruce

    The uncritical acceptance of Plato's treatment of sophistic doctrines (specifically in Plato's dialogue the "Gorgias") in the university has resulted in an impoverished contemporary view of sophistic rhetoric. Since Socrates' foundational epistemology allows for the knowledge of immutable truth and Gorgias' relativistic epistemology does…

  18. Purification through Emotions: The Role of Shame in Plato's "Sophist" 230B4-E5

    Science.gov (United States)

    Candiotto, Laura

    2018-01-01

    This article proposes an analysis of Plato's "Sophist" (230b4--e5) that underlines the bond between the logical and the emotional components of the Socratic "elenchus", with the aim of depicting the social valence of this philosophical practice. The use of emotions characterizing the 'elenctic' method described by Plato is…

  19. Infância e educação em Platão Childhood and education in Plato

    Directory of Open Access Journals (Sweden)

    Walter Omar Kohan

    2003-06-01

    adult citizen; c as superfluousness (childhood is not necessary to the polis, and d as matter of politics (the utopia is built from the education of children. It has not been our intention here to put Plato on trial. We have just sought to delimit an issue and a specific manner of tackling it with the aim of contributing to the analysis of the productivity of this perspective in the history of the philosophy of childhood and of Western education, as well as of current education theories and practices. At the same time, we have implicitly tried to offer elements to problematize a vision well established among historians of childhood - particularly after Philippe Ariès already classic Centuries of childhood: a social history of family life - according to which childhood would be a modern invention and would not have been "thought" as such by the ancients.

  20. The effect of TIcagrelor administered through a nasogastric tube to COMAtose patients undergoing acute percutaneous coronary intervention

    DEFF Research Database (Denmark)

    Ratcovich, Hanna; Sadjadieh, Golnaz; Andersson, Hedvig B

    2017-01-01

    resuscitated after an out of hospital cardiac arrest (OHCA) and undergoing primary percutaneous coronary intervention (pPCI). METHODS AND RESULTS: Blood samples were drawn at baseline and at two, four, six, eight, 12, and 24 hours and then daily for up to five days after administration of a 180 mg ticagrelor...... loading dose (LD), followed by 90 mg twice daily in 44 patients. The primary endpoint was the occurrence of high platelet reactivity (HPR) 12 hours after the LD. Assessment by VerifyNow (VFN) showed 96 (15.25-140.5) platelet reactivity units (PRU), and five (12%) patients exhibited HPR. Multiplate...... analysis showed 19 (12-29) units (U) at twelve hours, and three patients (7%) had HPR. Ticagrelor and its main metabolite AR-C124910XX concentrations were 85.2 (37.2-178.5) and 18.3 (6.4-52.4) ng/mL. Median times to sufficient platelet inhibition below the HPR limit were 3 (2-6) hours (VFN) and 4 (2...

  1. Reducing Microvascular Dysfunction in Revascularized Patients with ST-Elevation Myocardial Infarction by Off-Target Properties of Ticagrelor versus Prasugrel. Rationale and Design of the REDUCE-MVI Study

    NARCIS (Netherlands)

    G.N. Janssens (Gladys N.); M.A.H. van Leeuwen (Maarten); N.W. van der Hoeven (Nina W.); G.A. de Waard (Guus); R. Nijveldt (Robin); R. Diletti (Roberto); F. Zijlstra (Felix); C. Von Birgelen (Clemens); J. Escaned (Javier); M. Valgimigli (Marco); N. van Royen (Niels)

    2016-01-01

    textabstractMicrovascular injury is present in a large proportion of patients with ST-elevation myocardial infarction (STEMI) despite successful revascularization. Ticagrelor potentially mitigates this process by exerting additional adenosine-mediated effects. This study aims to determine whether

  2. Genesis 2–3 and Alcibiades's speech in Plato's Symposium : A ...

    African Journals Online (AJOL)

    Genesis 2–3 and Alcibiades's speech in Plato's Symposium : A cultural critical reading. ... Abstract. The purpose of this article is to discuss some basic problems and methodological steps concerning the encounter between Hebrews and Greeks in the Classical period and its impact on the Hellenistic era. The relationship ...

  3. Freud, Plato and Irigaray: A Morpho-Logic of Teaching and Learning

    Science.gov (United States)

    Peers, Chris

    2012-01-01

    This article discusses two well-known texts that respectively describe learning and teaching, drawn from the work of Freud and Plato. These texts are considered in psychoanalytic terms using a methodology drawn from the philosophy of Luce Irigaray. In particular the article addresses Irigaray's approach to the analysis of speech and utterance as a…

  4. From Plato to Erikson: How the War on "Bad Play" Has Impoverished Higher Education

    Science.gov (United States)

    Carnes, Mark C.

    2015-01-01

    For centuries, the titans of educational reform--Plato, Rousseau, Dewey, Piaget, Erikson, Csikszentmihalyi and others--have championed the educational benefits of play. Yet many professors and administrators are boggled by the idea of playing academic games in college. They instantly dismiss faculty initiatives like "Reacting to the…

  5. Can Prior Knowledge Hurt Text Comprehension? An Answer Borrowed from Plato, Aristotle, and Descartes.

    Science.gov (United States)

    Friedman, Lawrence B.

    Taking a philosophical approach based on what Plato, Aristotle, and Descartes said about knowledge, this paper addresses some of the murkiness in the conceptual space surrounding the issue of whether prior knowledge does or does not facilitate text comprehension. Specifically, the paper first develops a non-exhaustive typology of cases in which…

  6. The PLATO System: A Study in the Diffusion of an Innovation.

    Science.gov (United States)

    Driscoll, Francis D.; Wolf, W. C., Jr.

    This study was designed to ascertain the relationships between the steps of a tool designed to link knowledge production and the needs of knowledge users (the Wolf-Welsh Linkage Methodology or WWLM) with milestones in the evolution of an innovative computer-assisted instructional system called PLATO (Programming Logic for Advanced Teaching…

  7. God as Intellect in the philosophical Theology of Plato, Aristotle and Plotinus.

    Directory of Open Access Journals (Sweden)

    Nadezhda Volkova

    2017-12-01

    Full Text Available The article gives an overview of the main stages in the development of philosophical theology in Plato, Aristotle and Plotinus, as well as its central concept - Active Intellect or God. It is shown, firstly, that Plato was the first who formulated the concept of a One omnibenevolent God. Plato opposed this doctrine to the gods of traditional mythology. In the "Timaeus" talking about the creation of the world, Plato represents God as an artisan, i. e. Demiurge, who arranges the World soul and matter with the help of the numbers. Therefore, God is introduced as an Intellect, because looking at an intelligible paradigm, he created the cosmos as its likeness. Secondly, it was shown that Aristotle made theology demonstrative theoretical knowledge. God as a subject of such knowledge is the pure actuality of thinking. Third, it is shown that Plotinus, continuing the line of Plato and Aristotle, gave philosophical theology a new, much more personal character. Theology for Plotinus is not only an demonstrative knowledge of the omnibenevolent God, but also a personal experience of reunion with him. A special attention in the article is paid for Plotinus' interpretation of the Platonic Demiurge. It is shown that Plotinus first connected the two aspects of the divine, namely the Demiurge-creator and the intelligible paradigm that are described in the "Timaeus," into the single hypostasis of Intellect. The main reason for this assertion was the necessity to postulate the unity of the intellect and the intelligible object as a necessary condition for the possibility of all cognitions. As a result, instead of the traditional idea of the two gods, Plotinus elaborates the doctrine of a single divine Intellect, combining both these aspects.

  8. Plato crater, first observative session: not any "hook" but a shark fin? (Italian Title: La 1° Campagna Osservativa del cratere Plato: non un "uncino" ma una "pinna di squalo"?)

    Science.gov (United States)

    Mercatali, A.

    2018-01-01

    On 1st March 2012 an observative session of Moon's Plato crater was made. The purpose of these observations was to check the presence of one shadow with "hook" form at the inner of Plato crater already reported by H. Percy Wilkins, 3th April 21:30 UT, 1952. The results obtained by us have not shown any shadow with an hook form, but a shadow like a shark fin.

  9. Good and Bad: Love and Intimacy From Plato to Melanie Klein.

    Science.gov (United States)

    Stromberg, David

    2018-06-01

    Melanie Klein's theories on love outline a complex system of relations-an oscillating dynamic of psychical and emotional tendencies following from both actual experience and fantasies produced by the mind. Her insights are often discussed and applied in psychoanalytical contexts, but the philosophical implications of her theory-especially in relation to Platonic thought-have rarely been discussed. In this article, I will attempt to address this gap by setting out some preliminary yet core considerations shared by both Plato and Klein. First, I will describe some structural parallels between Kleinian and Platonic thought, especially in dialectical terms. Second, I will outline Plato's covert influence on Freud as passing through the teachings of philosopher Franz Brentano. And last, I will discuss intimacy as a struggle between the forces of good and bad, creativity and destruction, and love and hate-suggesting that Klein's conception of love emerges as a moral exigency.

  10. One aspect of the methodology of cognition in Plato and Dionysius the Areopagite

    Directory of Open Access Journals (Sweden)

    Moiseev, Petr

    2008-06-01

    Full Text Available Petr Moiseev (Perm State Institute of Arts and Cultureshows how the concept of ascension to truth, first formulated by Plato, was later reworked and reevaluated in new cognitive context by such later thinkers, as Plutarch, Iamblichus and, finally, Pseudo-Dionysius the Areopagite. Special attention is given to the concept of knowledge beyond human cognition and the role symbolism played in the process of its development.

  11. Los platos de los peces y el más allá

    OpenAIRE

    Aranegui Gascó, Carmen

    1996-01-01

    - Interpretación de la decoración de los platos de peces ibéticos como expresión de una determinada concepción del orden del universo y del tránsito a la otra vida. Flores, estrellas y espirales son la expresion de los tres elementos, mientras que el pez muestra el camino hacia el más allá.

  12. [History and reception of the translations of Plato's Dialogues by Antoni Bronikowski].

    Science.gov (United States)

    Mróz, Tomasz

    2014-01-01

    The article presents the history of translations of Plato's dialogues as made by A. Bronikowski (1817-1884), their assessment formulated by the contemporary for the translator recipients and today's opinions on them. Bronikowski began his translation work on the legacy of Plato in the '50s of the 19th century and carried them out systematically, despite the many adversities, until his death. The article presents the most important criticisms of the reviewers of Bronikowski's translations, which focused on the flaws of his style. The critics pointed out numerous shortcomings, archaisms, which hindered and prevented smooth reading of the text by readers unfamiliar with the language of the original. Most of the criticisms came from the Warsaw environment, especially from K. Kozłowski, the son of the first Polish translator of Plato, FA. Kozłowski. Among the defenders of Bronikowski there were K. Libelt and J.I. Kraszewski. They raised the subject of difficulty which the translator had to deal with and the lack of literary taste of the audience. It seems that both parties were partially right. Bronikowski's text was indeed not suitable for smooth reading in many places, however, it could serve as a useful tool for students who acquainted themselves with the Greek originals of the dialogues.

  13. The role of the poet in Plato's ideal cities of Callipolis and Magnesia

    Directory of Open Access Journals (Sweden)

    Gerard Naddaf

    2007-12-01

    Full Text Available Plato's attitude toward the poets and poetry has always been a flashpoint of debate, controversy and notoriety, but most scholars have failed to see their central role in the ideal cities of the Republic and the Laws, that is, Callipolis and Magnesia. In this paper, I argue that in neither dialogue does Plato "exile" the poets, but, instead, believes they must, like all citizens, exercise the expertise proper to their profession, allowing them the right to become full-fledged participants in the productive class. Moreover, attention to certain details reveals that Plato harnesses both positive and negative factors in poetry to bring his ideal cities closer to a practical realization. The status of the poet and his craft in this context has rarely to my knowledge been addressed.A atitude de Platão com relação aos poetas e à poesia tem sempre sido um ponto de debate, controvérsia e notoriedade, mas a maioria dos estudiosos não consegue ver seu papel central nas cidades ideais da República e das Leis, ou seja, Callipolis e Magnésia. Neste artigo, defendo que em nenhum dos dois diálogos Platão exila os poetas, mas, ao contrário, acredita que eles devem, como todos os cidadãos, exercitar a competência própria à sua profissão, permitindo-lhes o direito de se tornarem participantes com todos os direitos da classe produtora. Principalmente, se prestarmos a atenção devida em certos detalhes, veremos que Platão controla tanto os fatores positivos, como os negativos na poesia, para aproximar mais suas cidades ideais da realização prática. A meu ver, o estatuto do poeta e de sua habilidade, nesse contexto, foram raramente estudados.

  14. On-ground and in-orbit characterisation plan for the PLATO CCD normal cameras

    Science.gov (United States)

    Gow, J. P. D.; Walton, D.; Smith, A.; Hailey, M.; Curry, P.; Kennedy, T.

    2017-11-01

    PLAnetary Transits and Ocillations (PLATO) is the third European Space Agency (ESA) medium class mission in ESA's cosmic vision programme due for launch in 2026. PLATO will carry out high precision un-interrupted photometric monitoring in the visible band of large samples of bright solar-type stars. The primary mission goal is to detect and characterise terrestrial exoplanets and their systems with emphasis on planets orbiting in the habitable zone, this will be achieved using light curves to detect planetary transits. PLATO uses a novel multi- instrument concept consisting of 26 small wide field cameras The 26 cameras are made up of a telescope optical unit, four Teledyne e2v CCD270s mounted on a focal plane array and connected to a set of Front End Electronics (FEE) which provide CCD control and readout. There are 2 fast cameras with high read-out cadence (2.5 s) for magnitude ~ 4-8 stars, being developed by the German Aerospace Centre and 24 normal (N) cameras with a cadence of 25 s to monitor stars with a magnitude greater than 8. The N-FEEs are being developed at University College London's Mullard Space Science Laboratory (MSSL) and will be characterised along with the associated CCDs. The CCDs and N-FEEs will undergo rigorous on-ground characterisation and the performance of the CCDs will continue to be monitored in-orbit. This paper discusses the initial development of the experimental arrangement, test procedures and current status of the N-FEE. The parameters explored will include gain, quantum efficiency, pixel response non-uniformity, dark current and Charge Transfer Inefficiency (CTI). The current in-orbit characterisation plan is also discussed which will enable the performance of the CCDs and their associated N-FEE to be monitored during the mission, this will include measurements of CTI giving an indication of the impact of radiation damage in the CCDs.

  15. Dialectic of Eros and Myth of the Soul in Plato's Phaedrus

    DEFF Research Database (Denmark)

    Larsen, Jens Kristian

    2010-01-01

    In this paper, I question a widespread reading of a passage in the last part of the Phaedrus dealing with the science of dialectic. According to this reading, the passage announces a new method peculiar to the later Plato aiming at defining natural kinds. I show that the Phaedrus itself does not ...... not support such a reading. As an alternative reading, I suggest that the science of dialectic, as discussed in the passage, must be seen as dealing primarily with philosophical rhetoric and knowledge of human souls....

  16. Numbers Rule The Vexing Mathematics of Democracy, from Plato to the Present

    CERN Document Server

    Szpiro, George G

    2010-01-01

    Since the very birth of democracy in ancient Greece, the simple act of voting has given rise to mathematical paradoxes that have puzzled some of the greatest philosophers, statesmen, and mathematicians. Numbers Rule traces the epic quest by these thinkers to create a more perfect democracy and adapt to the ever-changing demands that each new generation places on our democratic institutions. In a sweeping narrative that combines history, biography, and mathematics, George Szpiro details the fascinating lives and big ideas of great minds such as Plato, Pliny the Younger, Ramon Llull, Pierre Simo

  17. [Plato's philosophy and the bioethical debate on the end of life: intersections in public health].

    Science.gov (United States)

    Siqueira-Batista, Rodrigo; Schramm, Fermin Roland

    2004-01-01

    This article discusses bioethical aspects of medical futility, focusing on some of its intersections in public health. Starting from a demarcation of finitude in the core of the philosophical and bioethical debate on the end of life, we confront the contemporary criticism regarding medical futility with the ideas of Plato (427-347 B.C.), a philosopher who proposed significant considerations on numerous features of the medicine of his time. We thus explore novel theoretic references to guide the disputes related to this essential problem, the implications of which are decisive to health and life.

  18. Slovenian test case Vrbanski Plato aquifer in the EU HORIZON 2020 FREEWAT project

    Directory of Open Access Journals (Sweden)

    Irena Kopač

    2017-09-01

    Full Text Available The Slovenian case study in the EU HORIZON 2020 FREEWAT project was Vrbanski Plato aquifer. Slovenia is divided into two river basin districts: the Danube and the North Adriatic. The Vrbanski Plato aquifer, which he presents both natural and artificial bank filtration from the river Drava, is a part of the Danube river basin district and is the most important water source for 14 municipalities in the northeastern part of Slovenia. We investigated the groundwatersurface water interaction between river Drava and the porous aquifer in the geological old riverbed and possible reduction of city impact. This site is the oldest managed artificial groundwater recharge with riverbank filtration and has more than thirty years of successful operation. It is something special, very abundant in a small space, independent of drought and climate changes, but vulnerable due to the impact of the city. Under the city there is watershed dividing, which is shifting with different water management condition and we would like to have the least possible impact of the city. For optimal water management we decided to use FREEWAT plug-in within QGIS platform. With new developed FREEWAT plug-in in project FREEWAT, we made steady-state and transient groundwater model for presenting this shift of the watershed dividing under the city and optimal water management for this area. The model was designed in a way that it identifies and describes all major aspects of the physical hydrogeological system and water management. During the running of a project, there was an accident with heating oil spillage in city area, right on the watershed dividing. So we oriented with the transient groundwater model as well on heating oil spillage and pumping with additional wells at the place of the accident to present successful rehabilitation and the importance of the managed groundwater recharge. Our experience with FREEWAT platform during the Vrbanski Plato aquifer case study was very

  19. Social developmnet of ecologically sensitive rural areas: Case studies of the Moravian Karst (Czech Republic) and the Devetashko Plato (Bulgaria)

    Czech Academy of Sciences Publication Activity Database

    Zapletalová, Jana; Stefanová, D.; Vaishar, Antonín; Stefanov, P.; Dvořák, Petr; Tcherkezova, E.

    3-4, 3-4 (2016), s. 65-84 ISSN 0204-7209 Institutional support: RVO:68145535 Keywords : social development * rural sensitive areas * Devetashko Plato * Bulgaria * Moravian karst - Czech Republic Subject RIV: DE - Earth Magnetism, Geodesy, Geography OBOR OECD: Cultural and economic geography http://geoproblems.eu/wp-content/uploads/2017/04/2016_34/4_zapletalova.pdf

  20. Three Aspects of PLATO Use at Chanute AFB: CBE Production Techniques, Computer-Aided Management, Formative Development of CBE Lessons.

    Science.gov (United States)

    Klecka, Joseph A.

    This report describes various aspects of lesson production and use of the PLATO system at Chanute Air Force Base. The first chapter considers four major factors influencing lesson production: (1) implementation of the "lean approach," (2) the Instructional Systems Development (ISD) role in lesson production, (3) the transfer of…

  1. Synergies Between the Kepler, K2 and TESS Missions with the PLATO Mission (Revised)

    Science.gov (United States)

    Jenkins, Jon M.

    2017-01-01

    Two transit survey missions will have been flown by NASA prior to the launch of ESA's PLATO Mission in 2026, laying the groundwork for exoplanet discovery via the transit method. The Kepler Mission, which launched in 2009, collected data on its 100+ square degree field of view for four years before failure of a reaction wheel ended its primary mission. The results from Kepler include 2300+ confirmed or validated exoplanets, 2200+ planetary candidates, 2100+ eclipsing binaries. Kepler also revolutionized the field of asteroseismology by measuring the pressure mode oscillations of over 15000 solar-like stars spanning the lifecycle of such stars from hydrogen-burning dwarfs to helium-burning red giants. The re-purposed Kepler Mission, dubbed K2, continues to observe fields of view in and near the ecliptic plane for 80 days each, significantly broadening the scope of the astrophysical investigations as well as discovering an additional 156 exoplanets to date. The TESS mission will launch in 2017 to conduct an all-sky survey for small exoplanets orbiting stars 10X closer and 100X brighter than Kepler exoplanet host stars, allowing for far greater follow-up and characterization of their masses as well as their sizes for at least 50 small planets. Future assets such as James Webb Space Telescope, and ground-based assets such as ESOs Very Large Telescope (VLT) array, the Exremely Large Telescope (ELT), and the Thirty Meter Telescope (TMT) will be able to characterize the atmospheric composition and properties of these small planets. TESS will observe each 24 X 96 field of view for 30 days and thereby cover first the southern and then the northern hemisphere over 13 pointings during each year of the primary mission. The pole-most camera will observe the James Webb continuous viewing zone for one year in each hemisphere, permitting much longer period planets to be detected in this region. The PLATO mission will seek to detect habitable Earth-like planets with an instrument

  2. PLATO: a computer code for the analysis of fission product plateout in HTGRs

    International Nuclear Information System (INIS)

    Suzuki, Katsuo; Morimoto, Toshio.

    1981-01-01

    The computer code PLATO for estimating plateout activities on surfaces of primary cooling system of HTGRs has been developed, and in this report, analytical model and digital calculation method incorporated in the code are described. The code utilizes the mass transfer model analogous to heat transfer coupled with an expression for adsorption-desorption phenomenon, and is able to analyze plateout behaviours in a closed circuit, like a reactor cooling system, which is constructed from a various kind of components, as well as in an open-ended tube. With the code, fission product concentration in the coolant and plateout amount on the surfaces are calculated along the coolant stream, and total removal rate by the plateout process is also obtained. Comparison of the analytical results with the experimental results, including checks of the effects of some calculation conditions on the results, and preliminary analysis on the VHTR plant have been made. (author)

  3. Efficient methods for solving discrete topology design problems in the PLATO-N project

    DEFF Research Database (Denmark)

    Canh, Nam Nguyen; Stolpe, Mathias

    This paper considers the general multiple load structural topology design problems in the framework of the PLATO-N project. The problems involve a large number of discrete design variables and were modeled as a non-convex mixed 0–1 program. For the class of problems considered, a global...... optimization method based on the branch-and-cut concept was developed and implemented. In the method a large number of continuous relaxations were solved. We also present an algorithm for generating cuts to strengthen the quality of the relaxations. Several heuristics were also investigated to obtain efficient...... algorithms. The branch and cut method is used to solve benchmark examples which can be used to validate other methods and heuristics....

  4. On social justice: Comparing Paul with Plato, Aristotle and the Stoics

    Directory of Open Access Journals (Sweden)

    Johan Strijdom

    2007-05-01

    Full Text Available n “In search of Paul” (2004 Crossan and Reed argue that Paul’s vision and program were essentially in continuity with Jesus’: both opposed, be it in Galilean villages or Roman cities, an unjust imperial system by means of an alternative project of egalitarian, distributive justice. Although Crossan elsewhere demonstrates the deep roots of this concern in the Jewish tradition, he tends to downplay the importance of Greek contributions in this regard. The purpose of this essay will be to offer, in constant dialogue with Crossan (and Reed, a more refined comparison of social justice in Paul on the one hand and Plato, Aristotle and the Stoics on the other. If Paul tried to establish egalitarian and sharing Christian communities under the Roman empire, how do this vision and program compare and contrast with Plato's hierarchical but communal concept of justice, Aristotle’s distributive notion according to merit, and most importantly the Stoics’ argument of “oikeiosis” (i.e., other-concern by concentrical familiarization with the other? Imagine, say Crossan and Reed (CR hereafter in their recent book on Paul, the following dialogue between ourselves and Paul: Do you think, Paul, that all men are created equal and endowed by their Creator with certain inalienable rights? I am not speaking about all men, but about all Christians. But do you think, Paul, that all people should be Christians? Yes, of course,. And do you think, Paul, that all Christians should be equal with one another?Yes, of course. Then do you think, Paul, that it is God’s will for all people to be equal with one another? Well, let me think about that one for a while and, in the meantime, you think about equality in Christ. (CR 2004:234

  5. Simulation results for PLATO: a prototype hybrid X-ray photon counting detector with a low energy threshold for fusion plasma diagnostics

    International Nuclear Information System (INIS)

    Habib, A.; Menouni, M.; Pangaud, P.; Morel, C.; Fenzi, C.; Colledani, G.; Moureau, G.; Escarguel, A.

    2017-01-01

    PLATO is a prototype hybrid X-ray photon counting detector that has been designed to meet the specifications for plasma diagnostics for the WEST tokamak platform (Tungsten (W) Environment in Steady-state Tokamak) in southern France, with potential perspectives for ITER. PLATO represents a customized solution that fulfills high sensitivity, low dispersion and high photon counting rate. The PLATO prototype matrix is composed of 16 × 18 pixels with a 70 μm pixel pitch. New techniques have been used in analog sensitive blocks to minimize noise coupling through supply rails and substrate, and to suppress threshold dispersion across the matrix. The PLATO ASIC is designed in CMOS 0.13 μm technology and was submitted for a fabrication run in June 2016. The chip is designed to be bump-bonded to a silicon sensor. This paper presents pixel architecture as well as simulation results while highlighting novel solutions.

  6. Plato (power load analysis tool) - a module of west wall monitoring system

    International Nuclear Information System (INIS)

    Ranjan, Sutapa; Travere, Jean-marcel; Moreau, P.

    2015-01-01

    The mandate of the WEST (W Environment for Steady-state Tokamak) project, is to upgrade the medium- sized superconducting Tokamak, Tore Supra in a major scale. One of it's objectives, is to also act as a test-bed for ITER divertor components, to be procured and used in ITER. WEST would be installing actively cooled Tungsten divertor elements, like the ones to be used in ITER. These components would be tested under two experimental scenarios: high power (Ip = 0.8MA, lasting 30s with 15MW injected power) and high fluence (Ip = 0.6 MA, lasting 1000s with 12 MW injected power). Heat load on the divertor target will range from a few MW/m 2 up to 20 MW/m 2 depending on the X point location and the heat flux decay length. The tungsten Plasma Facing Components (PFCs) are less tolerant to overheating than their Carbon counterparts and prevention of their burnout is a major concern. It is in this context that the Wall Monitoring System (WMS) - a software framework aimed at monitoring the health of the Wall components, was conceived. WMS has been divided into three parts: a) a pre-discharge power load analysis tool to check compatibility between plasma scenario and PFC's operational limits in terms of heat flux b) a real-time system during discharge, to take into account all necessary measurements involved in the PFCs protection c) a set of analysis tools that would be used post-discharge, that would access WEST database and compare predicted and experimental results. This paper presents an overview of PLATo - the pre-pulse module of WMS that has been recently developed under IPR-IRFM research collaboration. PLAto has two major components - one that produces heat flux information of the PFCS and the other that produces energy graphs depending on shot profile defined by time variant magnetic equilibrium and injected power profiles. Preliminary results will be presented based on foreseen WEST plasma reference scenarios. (author)

  7. From Pericles to Plato – from democratic political praxis to totalitarian political philosophy

    Directory of Open Access Journals (Sweden)

    Øjvind Larsen

    2012-03-01

    Full Text Available Plato is normally taken as one of the founders of Western political philosophy, not at least with his Republic. Here, he constructs a hierarchy of forms of governments, beginning with aristocracy at the top as a critical standard for the other forms of governments, and proceeding through timocracy and oligarchy to democracy and tyranny at the bottom. Following Karl Popper, the paper argues that Plato’s is a totalitarian philosophy that emphasizes the similarities between democracy and tyranny, which it considers to be the two worst forms of government. Plato’s denigration of democracy has dominated the tradition of political philosophy until recent times. This paper, however, shows that political philosophy in fact originates in democracy, especially as developed by the sophists and that philosophy is only a form of sophism with a similar origin in ancient Greek democracy. A discussion of Pericles’ funeral oration is used to show that Pericles presented a democratic political philosophy that can serve as a counterpoint to Plato’s political philosophy in the Republic.

  8. The experimental and theoretical landscape of a new antiplatelet drug ticagrelor: Insight into supramolecular architecture directed by Csbnd H⋯F, π⋯π and Csbnd H⋯π interactions

    Science.gov (United States)

    Bojarska, Joanna; Remko, Milan; Fruziński, Andrzej; Maniukiewicz, Waldemar

    2018-02-01

    The crystal and molecular structure landscape of a new drug ticagrelor has been investigated by using experimental and theoretical approach. The structures of this cyclopentyl-triazolo-pyrimidine derivative, (1) and its DMSO solvate (2), were determined by SC-XRD at 100 K. (1) crystallizes in the orthorhombic space group P21212 with four independent molecules, while (2) belongs to the monoclinic system with the space group C2, including two ticagrelor and 0.5 DMSO molecules in the asymmetric unit. Both crystals present diverse interactions, such as: Osbnd H⋯O, Nsbnd H⋯O and Csbnd H⋯X (X = O, N, F, S). H-bonds between Ntriazolopyrimidine and sbnd OH groups of cyclopentane-1,2-diol ring connect ticagrelor molecules into dimers forming three fused rings, encoded as R22(9) and R22(10) graph-set motifs, which are further linked by Chydroxyethoxy-H⋯Fsbnd C3,4difluorophenyl into a supramolecular chain. A comparative insight into the studies of all contacts in the crystal lattices of ticagrelors and other related adenosine derivatives from the CSD was provided using Hirshfeld surface analysis. It highlights a significant difference in terms of various substituents. Notably, F⋯H/H⋯F are more meaningful than O⋯H/H⋯O and N⋯H/H⋯N H-bonds. The π⋯π stacking and Csbnd H⋯π interactions participate in a cooperative way to stabilize the supramolecular architecture. The geometry of both ticagrelor forms was optimized in the gas-phase and solvated state, using the DFT method, at the Becke 3LYP/B97D level. The theoretical results show a good agreement with those obtained from the X-ray study. Moreover, structural elucidation of a new drug was extended by 1D 1H, 13C NMR, 2D 1H, 13C HSQC NMR, FT-IR and TG/DTG techniques.

  9. Dosimetric evaluation of PLATO and Oncentra treatment planning systems for High Dose Rate (HDR) brachytherapy gynecological treatments

    Energy Technology Data Exchange (ETDEWEB)

    Singh, Hardev; De La Fuente Herman, Tania; Showalter, Barry; Thompson, Spencer J.; Syzek, Elizabeth J.; Herman, Terence; Ahmad, Salahuddin [Department of Radiation Oncology, Peggy and Charles Stephenson Oklahoma Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104 (United States)

    2012-10-23

    This study compares the dosimetric differences in HDR brachytherapy treatment plans calculated with Nucletron's PLATO and Oncentra MasterPlan treatment planning systems (TPS). Ten patients (1 T1b, 1 T2a, 6 T2b, 2 T4) having cervical carcinoma, median age of 43.5 years (range, 34-79 years) treated with tandem and ring applicator in our institution were selected retrospectively for this study. For both Plato and Oncentra TPS, the same orthogonal films anterior-posterior (AP) and lateral were used to manually draw the prescription and anatomical points using definitions from the Manchester system and recommendations from the ICRU report 38. Data input for PLATO was done using a digitizer and Epson Expression 10000XL scanner was used for Oncentra where the points were selected on the images in the screen. The prescription doses for these patients were 30 Gy to points right A (RA) and left A (LA) delivered in 5 fractions with Ir-192 HDR source. Two arrangements: one dwell position and two dwell positions on the tandem were used for dose calculation. The doses to the patient points right B (RB) and left B (LB), and to the organs at risk (OAR), bladder and rectum for each patient were calculated. The mean dose and the mean percentage difference in dose calculated by the two treatment planning systems were compared. Paired t-tests were used for statistical analysis. No significant differences in mean RB, LB, bladder and rectum doses were found with p-values > 0.14. The mean percent difference of doses in RB, LB, bladder and rectum are found to be less than 2.2%, 1.8%, 1.3% and 2.2%, respectively. Dose calculations based on the two different treatment planning systems were found to be consistent and the treatment plans can be made with either system in our department without any concern.

  10. Love and/in psychoanalysis: a commentary on Lacan's reading of Plato's Symposium in Seminar VIII: Transference.

    Science.gov (United States)

    Fink, Bruce

    2015-02-01

    What is love and what part does it play in psychoanalysis? Where are the analyst and the analysand situated in relation to the roles defined as those of the "lover" and the "beloved"? Jacques Lacan explores these and other questions in his soon-to-be-published Seminar VIII: Transference by providing an extensive commentary on Plato's most famous dialogue on love, the Symposium. This paper outlines some of the major points about love that grow out of Lacan's reading of the dialogue and examines their relevance to the analytic setting. Can the analyst be characterized as a sort of modern-day Socrates?

  11. Ancient philosophical ideas of the soul (Plato-Aristotelian tradition and Stoicism as a source of Patristic Thought

    Directory of Open Access Journals (Sweden)

    Zaitsev Cornelius

    2014-10-01

    Full Text Available The article discusses the ancient idea of the soul that in the patristic era has been enriched by the perception of the methodology of ancient philosophy. Greek and Roman thinkers considered some properties of the soul, its immortality, revealed its “levels and strata” (Plato, Aristotle, expressed first guesses about the nature of sinful passions (the Stoics. But some aspects still remained unresolved so far. This is the issue of materiality or immateriality, of the soul, which "raised" in the Russian Empire in the 19th century (the dispute saints Theophan the Recluse and Ignatius Brianchaninov and remains relevant today.

  12. [Plato's conceptions of disorders of the soul (Ta peri psuchên nosêmata). Timaeus as the beginning of a dynamic and ethic psychopathology].

    Science.gov (United States)

    Godderis, J

    1998-01-01

    This contribution to the study of the evolution of fundamental concepts in psychiatry, and in particular of the interpretative models of mental disease, focuses on Plato's conceptions concerning the "disorders of the soul". Plato's "psychopathological" work suggests the decline of an hereditary conglomeration of interpretative arrangements of the irrational phenomena related to mental disease which, corresponding to the social needs of that time, had been united by the belief in myth and its therapeutic value. These archaic religious conceptions have most certainly been reversed by Plato, especially in his Timaeus, one of the three most influential of his dialogues. In a notable passage in this cosmological dialogue (86b ff.) Plato treats of those diseases of the soul which are caused by things physical, whether this be a "defective bodily constitution" or "faulty education". The diseases of the soul are thus no longer considered having a divine origin. Mental diseases to which man is unwittingly subject by defects in birth or education concern himself and his inner life and they cannot be dismissed with simplistic allegories. According to Plato they originate from a conflict, supported by a secret, hidden, irrational "self" that has its roots in the sôma, the rational "self" being only able to recuperate its total integrity if it manages, through self-discipline and knowledge, to check the somatic impulses, the folly of the body. Also, Plato offers a series of remedies to correct the undue influence of body on soul and soul on body, with a view to instituting a right balance and proportion between them. This, together with a stress on "care of the soul", particularly of the divine and immortal element, implicitly assumes that it is in man's power to apply the necessary remedies to himself and effect some sort of readjustment.

  13. The micro-fascism of Plato's good citizen: producing (dis)order through the construction of risk.

    Science.gov (United States)

    O'Byrne, Patrick; Holmes, Dave

    2007-04-01

    The human body has come to be seen as forever susceptible to both external and internal hazards, which in many circumstances require immediate, heroic, and expensive intervention. In response to this, there has been a shift from a treatment-based healthcare model to one of prevention wherein nurses play an integral role by identifying and assessing risks for individuals, communities, and populations. This paper uses Deborah Lupton's outline of the spectrum of risk and applies the theoretical works of Foucault and Plato to demonstrate the means by which nurses maintain social order by identifying and counselling risk takers. It also utilizes the work of Deleuze and Guattari to illustrate how Plato's framework for creating social order through the creation of the good citizen can be viewed as a micro-fascist system, which has been adopted wholeheartedly by preventative health professionals. The goal of this paper is to present an alternate understanding of risk to provide nurses and other healthcare professionals with a non-traditional appreciation of certain aspects of their practice as researchers and clinicians.

  14. The P2Y12 Receptor Antagonist Ticagrelor Reduces Lysosomal pH and Autofluorescence in Retinal Pigmented Epithelial Cells From the ABCA4-/- Mouse Model of Retinal Degeneration

    Directory of Open Access Journals (Sweden)

    Wennan Lu

    2018-04-01

    Full Text Available The accumulation of partially degraded lipid waste in lysosomal-related organelles may contribute to pathology in many aging diseases. The presence of these lipofuscin granules is particularly evident in the autofluorescent lysosome-associated organelles of the retinal pigmented epithelial (RPE cells, and may be related to early stages of age-related macular degeneration. While lysosomal enzymes degrade material optimally at acidic pH levels, lysosomal pH is elevated in RPE cells from the ABCA4-/- mouse model of Stargardt’s disease, an early onset retinal degeneration. Lowering lysosomal pH through cAMP-dependent pathways decreases accumulation of autofluorescent material in RPE cells in vitro, but identification of an appropriate receptor is crucial for manipulating this pathway in vivo. As the P2Y12 receptor for ADP is coupled to the inhibitory Gi protein, we asked whether blocking the P2Y12 receptor with ticagrelor could restore lysosomal acidity and reduce autofluorescence in compromised RPE cells from ABCA4-/- mice. Oral delivery of ticagrelor giving rise to clinically relevant exposure lowered lysosomal pH in these RPE cells. Ticagrelor also partially reduced autofluorescence in the RPE cells of ABCA4-/- mice. In vitro studies in ARPE-19 cells using more specific antagonists AR-C69931 and AR-C66096 confirmed the importance of the P2Y12 receptor for lowering lysosomal pH and reducing autofluorescence. These observations identify P2Y12 receptor blockade as a potential target to lower lysosomal pH and clear lysosomal waste in RPE cells.

  15. The Case against the Arts from Plato to Tolstoy and Its Implications for Why and How the Arts Should Be Taught in Schools

    Science.gov (United States)

    Tate, Nicholas

    2016-01-01

    From Plato onwards many of the great Western thinkers have explored the nature of the arts, their contribution to society and their role in education. This has often involved a discussion of the potentially negative impact of the arts. The recurring message has been that the arts can warp judgment, elevate emotion at the expense of reason,…

  16. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  17. A hipotética linguagem ideal de Platão Plato's hypothetical ideal language

    Directory of Open Access Journals (Sweden)

    Maria Carolina Alves dos Santos

    2003-01-01

    Full Text Available Para que um discurso sobre o espetáculo do mundo transcendente seja acolhido como totalidade inteligível e coerente, urge desvencilhar-se da arbitrariedade do domínio de trêmulos contornos do sensível, esfera de opiniões apenas. É o que propõe Platão, na esteira das reflexões dos primeiros pensadores: para suprir deficiências que causam a elisão da realidade e transformar a linguagem num veículo de intelecção autêntica dos conceitos essenciais de um pensar filosófico, ele a coloca no centro de uma especulação rigorosa. Tal como seus antecessores Heráclito e Parmênides, Platão revela logofilia ao empenhar-se na construção de uma nova estrutura discursiva, diferente daquela do homem comum, desencadeando no campo da Filosofia uma revolução que se tornara indispensável: elabora um modelo fundador - princípio de uma ordem permanente propedêutica à construção de uma linguagem formal e abstrata - referente a entes que os homens, na maioria, por si mesmos não conseguem visualizar. Somente nela poderá reverberar a verdade universal das Formas que, ao emprestarem seus nomes à infindável série dos particulares sensíveis, os clarifica e lhes confere significação. Com as teorias que a partir das Formas desenvolve e expõe nos Diálogos, o filósofo visa induzir o leitor a preparar-se para operar, metodicamente, a conversão de sua alma ao plano desses seres ideais, supra-sensíveis, e apreender, assim, a realidade que tudo fundamenta e torna cognoscível.For a discourse on the spectacle of the transcendental world to be received in its comprehensible and coherent totality, its needs to get rid of the arbitrariness of the dominion of tremulous shapes of the sensitive, which is merely the sphere of opinions. This is what Plato suggests, following the course of reflection of the first thinkers: in order to compensate the deficiencies that entail elision of reality and to transform language into a vehicle of authentic

  18. Clockwise rotation of the Santa Marta massif and simultaneous Paleogene to Neogene deformation of the Plato-San Jorge and Cesar-Ranchería basins

    Science.gov (United States)

    Montes, Camilo; Guzman, Georgina; Bayona, German; Cardona, Agustin; Valencia, Victor; Jaramillo, Carlos

    2010-10-01

    A moderate amount of vertical-axis clockwise rotation of the Santa Marta massif (30°) explains as much as 115 km of extension (stretching of 1.75) along its trailing edge (Plato-San Jorge basin) and up to 56 km of simultaneous shortening with an angular shear of 0.57 along its leading edge (Perijá range). Extensional deformation is recorded in the 260 km-wide, fan-shaped Plato-San Jorge basin by a 2-8 km thick, shallowing-upward and almost entirely fine-grained, upper Eocene and younger sedimentary sequence. The simultaneous initiation of shortening in the Cesar-Ranchería basin is documented by Mesozoic strata placed on to lower Eocene syntectonic strata (Tabaco Formation and equivalents) along the northwest-verging, shallow dipping (9-12° to the southeast) and discrete Cerrejón thrust. First-order subsidence analysis in the Plato-San Jorge basin is consistent with crustal stretching values between 1.5 and 2, also predicted by the rigid-body rotation of the Santa Marta massif. The model predicts about 100 km of right-lateral displacement along the Oca fault and 45 km of left-lateral displacement along the Santa Marta-Bucaramanga fault. Clockwise rotation of a rigid Santa Marta massif, and simultaneous Paleogene opening of the Plato-San Jorge basin and emplacement of the Cerrejón thrust sheet would have resulted in the fragmentation of the Cordillera Central-Santa Marta massif province. New U/Pb ages (241 ± 3 Ma) on granitoid rocks from industry boreholes in the Plato-San Jorge basin confirm the presence of fragments of a now segmented, Late Permian to Early Triassic age, two-mica, granitic province that once spanned the Santa Marta massif to the northernmost Cordillera Central.

  19. A dialogical exploration of the grey zone of health and illness: medical science, anthropology, and Plato on alcohol consumption.

    Science.gov (United States)

    Bonner, Kieran

    2009-01-01

    This paper takes a phenomenological hermeneutic orientation to explicate and explore the notion of the grey zone of health and illness and seeks to develop the concept through an examination of the case of alcohol consumption. The grey zone is an interpretive area referring to the irremediable zone of ambiguity that haunts even the most apparently resolute discourse. This idea points to an ontological indeterminacy, in the face of which decisions have to be made with regard to the health of a person (e.g., an alcoholic), a system (e.g., the health system), or a society. The fundamental character of this notion will be developed in relation to the discourse on health and the limitations of different disciplinary practices. The case of alcohol consumption will be used to tease out the grey zone embedded in the different kinds of knowledge made available through the disciplinary traditions of medical science, with its emphasis on somatic well-being, and anthropology, with its focus on communal well-being. This tension or grey zone embedded in different knowledge outcomes will be shown to have a discursive parallel with the dialogue between the Athenian, the Spartan, and the Cretan in Plato's Laws. Making use of the dialogical approach as described by Gadamer, the Athenian's particular resolution of the tension will be explored as a case study to demonstrate the necessarily particular analysis involved in a grey zone resolution.

  20. What is good sport: Plato's view Co je to dobrý sport: Platónův pohled

    Directory of Open Access Journals (Sweden)

    Jernej Pisk

    2006-02-01

    Full Text Available One of Plato's most common questions found in his dialogues is "What is something?" By asking this question Plato usually brought his co-speakers to the recognition that in fact they do not have a full comprehension of what something is, although they have a partial comprehension of it. The awareness of one's incomplete cognition is the first step to be made on the philosophic way to truth. As in ancient times also today Plato asks us – the modern philosophers of sport – "What is sport?" or more precisely "What is good sport?" Probably the best of Plato's answers to this question can be found in the basic concepts of his philosophy regarding his hierarchical division of the state and human soul into three parts. Since sport is derived from human being also the goodness of sport can be divided into three stages. The lowest stage of sport corresponds to the first part of the soul – the appetite soul. On this stage sport is based on the gaining of material goods through prizes won at competitions. In the philosophic view, this is the lowest possible stage of goodness of sport. The second stage of sport corresponds to the second part of the soul – the emotional soul. Sport at this stage is based on the elementary ancient agon, which seeks fulfilment in the winning of honour and glory. The greatest and the most superior is the third part of the soul – the reasonable soul. According to this, also the sport corresponding to the third part of the soul is the best. For this kind of sport it is no longer necessary to compete with other contestants, since it can achieve it's fulfilment in perfect execution of movement or exercise, in which the perfect cooperation between reason (soul and body is attained. At this stage of sport it is the most important to compete and win over one's self, and this can be achieved by everyone, without regard to his/her physical abilities in comparison with others. In Plato's view, good sport is the sport directed

  1. Refractory Abundances of Terrestrial Planets and Their Stars: Testing [Si/Fe] Correlations with TESS and PLATO

    Science.gov (United States)

    Wolfgang, Angie; Fortney, Jonathan

    2018-01-01

    In standard models for planet formation, solid material in protoplanetary disks coagulate and collide to form rocky bodies. It therefore seems reasonable to assume that their chemical composition will follow the abundances of refractory elements, such as Si and Fe, in the host star, which has also accreted material from the disk. Backed by planet formation simulations which validate this assumption, planetary internal structure models have begun to use stellar abundances to break degeneracies in low-mass planet compositions inferred only from mass and radius. Inconveniently, our own Solar System contradicts this approach, as its terrestrial bodies exhibit a range of rock/iron ratios and the Sun's [Si/Fe] ratio is offset from the mean planetary [Si/Fe]. In this work, we explore what number and quality of observations we need to empirically measure the exoplanet-star [Si/Fe] correlation, given future transit missions, RV follow-up, and stellar characterization. Specifically, we generate synthetic datasets of terrestrial planet masses and radii and host star abundances assuming that the planets’ bulk [Si/Fe] ratio exactly tracks that of their host stars. We assign measurement uncertainties corresponding to expected precisions for TESS, PLATO, Gaia, and future RV instrumentation, and then invert the problem to infer the planet-star [Si/Fe] correlation given these observational constraints. Comparing the result to the generated truth, we find that 1% precision on the planet radii is needed to test whether [Si/Fe] ratios are correlated between exoplanet and host star. On the other hand, lower precisions can test for systematic offsets between planet and star [Si/Fe], which can constrain the importance of giant impacts for extrasolar terrestrial planet formation.

  2. Accuracy evaluation of fusion of CT, MR, and SPECT images using commercially available software packages (SRS PLATO and IFS)

    International Nuclear Information System (INIS)

    Mongioj, Valeria; Brusa, Anna; Loi, Gianfranco; Pignoli, Emanuele; Gramaglia, Alberto; Scorsetti, Marta; Bombardieri, Emilio; Marchesini, Renato

    1999-01-01

    Purpose: A problem for clinicians is to mentally integrate information from multiple diagnostic sources, such as computed tomography (CT), magnetic resonance (MR), and single photon emission computed tomography (SPECT), whose images give anatomic and metabolic information. Methods and Materials: To combine this different imaging procedure information, and to overlay correspondent slices, we used commercially available software packages (SRS PLATO and IFS). The algorithms utilize a fiducial-based coordinate system (or frame) with 3 N-shaped markers, which allows coordinate transformation of a clinical examination data set (9 spots for each transaxial section) to a stereotactic coordinate system. The N-shaped markers were filled with fluids visible in each modality (gadolinium for MR, calcium chloride for CT, and 99m Tc for SPECT). The frame is relocatable, in the different acquisition modalities, by means of a head holder to which a face mask is fixed so as to immobilize the patient. Position errors due to the algorithms were obtained by evaluating the stereotactic coordinates of five sources detectable in each modality. Results: SPECT and MR position errors due to the algorithms were evaluated with respect to CT: Δx was ≤ 0.9 mm for MR and ≤ 1.4 mm for SPECT, Δy was ≤ 1 mm and ≤ 3 mm for MR and SPECT, respectively. Maximal differences in distance between estimated and actual fiducial centers (geometric mismatch) were in the order of the pixel size (0.8 mm for CT, 1.4 mm for MR, and 1.8 mm for SPECT). In an attempt to distinguish necrosis from residual disease, the image fusion protocol was studied in 35 primary or metastatic brain tumor patients. Conclusions: The image fusion technique has a good degree of accuracy as well as the potential to improve the specificity of tissue identification and the precision of the subsequent treatment planning

  3. Viewpoint: "underutilisation of novel antiplatelet agents--myths, generics, and economics".

    Science.gov (United States)

    Serebruany, V L; Fortmann, S D

    2014-07-03

    Two oral antiplatelet agents have been recently introduced for acute coronary syndromes indication providing alternatives for dual therapy with aspirin and clopidogrel. In fact, worldwide prasugrel has been on the market for four years, and ticagrelor for over two years. Despite declared benefits over clopidogrel, including hypothetical cost saving advantages, in real life, the clinical utilisation of both agents is small. Generic clopidogrel, and price differences are claimed as major obstacles to prevent broader prasugrel and ticagrelor use. However, these economic difficulties are barely supported by available evidence, and served mostly to protect questionable management spending, as an exuse to explain why in reality cardiologists are so sceptical about both novel agents, and to convince the sharehoders that their money is not wasted, misleading the owners with regard to future success. Importantly, brand Plavix® is used worldwide 5-10 times more often than new agents, despite heavy generic competition. The future of prasugrel outside Japan, where much lower reasonable dose will be used is not impressive due to lack of further outcome studies, negative results of the latest trials, and less than four years left before patent expiration. The fate of ticagrelor will depend on verification of deaths numbers in the ongoing United States Department of Justice PLATO investigation, and confirmation of the mortality benefit in the PEGASUS TIMI-54 trial.

  4. A display model for the TOU of PLATO: just a cool toy or a benchmark of opportunities?

    Science.gov (United States)

    Dima, M.; Greggio, D.; Bergomi, M.; Biondi, F.; Farinato, J.; Farisato, G.; Magrin, D.; Lessio, L.; Marafatto, L.; Munari, M.; Pagano, I.; Ragazzoni, R.; Viotto, V.; Piazza, D.

    2016-07-01

    We produced a "toy-model" of one Telescope Optical Unit of PLATO, the Medium sized mission selected by ESA to fly in 2024. This is a six lenses dioptric very wide field camera with a window in front to take care of radiation impact on the first lens whose optical glass cannot be replaced with a radiation hardened one. The main aim of this project is just to produce a "cool" model for display purposes, in which one can "explore" the details of the inside through some openings in the tube, in order to visually inspect some of the fine details of the opto-mechanics. While its didactic and advertising role is out of doubt, during its construction we realized that some interesting outcome can be of some relevance for the project itself and that some findings could be useful, in order to assess the ability of producing with the same technology some (of course of much more modest quality) optical systems. In this context, we immediately dropped the option of producing the lenses with opaque material painted with a color resembling a refractive material (like blue for instance) and decided to actually produce them with transparent plastic. Furthermore the surfaces are then finely polished in order to give them basic optical properties. Such an optical system has only very coarsely the converging properties of the original nominal design for a number of reasons: the refractive indexes are not the nominal ones, the quality of the surfaces and their nominal values are only roughly, within a few percent, the targeted one, and the way the surfaces are built up makes them prone to some diffraction effects. However, the bulk of the lens and the surface roughness will give a large magnification of the scattering effects that will be experienced, at a much lower level, on the actual flight model. We investigated through propagation of a laser beam and by digital camera the main stray light modes that this toymodel offers. In other words, the model amplifies, to a large extent, the

  5. Clinical impact and predictors of complete ST segment resolution after primary percutaneous coronary intervention: A subanalysis of the ATLANTIC Trial.

    Science.gov (United States)

    Fabris, Enrico; van 't Hof, Arnoud; Hamm, Christian W; Lapostolle, Frédéric; Lassen, Jens F; Goodman, Shaun G; Ten Berg, Jurriën M; Bolognese, Leonardo; Cequier, Angel; Chettibi, Mohamed; Hammett, Christopher J; Huber, Kurt; Janzon, Magnus; Merkely, Béla; Storey, Robert F; Zeymer, Uwe; Cantor, Warren J; Tsatsaris, Anne; Kerneis, Mathieu; Diallo, Abdourahmane; Vicaut, Eric; Montalescot, Gilles

    2017-08-01

    In the ATLANTIC (Administration of Ticagrelor in the catheterization laboratory or in the Ambulance for New ST elevation myocardial Infarction to open the Coronary artery) trial the early use of aspirin, anticoagulation, and ticagrelor coupled with very short medical contact-to-balloon times represent good indicators of optimal treatment of ST-elevation myocardial infarction and an ideal setting to explore which factors may influence coronary reperfusion beyond a well-established pre-hospital system. This study sought to evaluate predictors of complete ST-segment resolution after percutaneous coronary intervention in ST-elevation myocardial infarction patients enrolled in the ATLANTIC trial. ST-segment analysis was performed on electrocardiograms recorded at the time of inclusion (pre-hospital electrocardiogram), and one hour after percutaneous coronary intervention (post-percutaneous coronary intervention electrocardiogram) by an independent core laboratory. Complete ST-segment resolution was defined as ≥70% ST-segment resolution. Complete ST-segment resolution occurred post-percutaneous coronary intervention in 54.9% ( n=800/1456) of patients and predicted lower 30-day composite major adverse cardiovascular and cerebrovascular events (odds ratio 0.35, 95% confidence interval 0.19-0.65; pST-segment resolution were the time from symptoms to pre-hospital electrocardiogram (odds ratio 0.91, 95% confidence interval 0.85-0.98; pST-segment resolution (odds ratio 1.22, 95% confidence interval 0.99-1.51; p=0.06). This study confirmed that post-percutaneous coronary intervention complete ST-segment resolution is a valid surrogate marker for cardiovascular clinical outcomes. In the current era of ST-elevation myocardial infarction reperfusion, patients' delay and diabetes mellitus are independent predictors of poor reperfusion and need specific attention in the future.

  6. EVALUATION OF COST-EFFECTIVENESS OF PLATELET REACTIVITY ANALYSIS USING THE VERIFYNOW P2Y12 ASSAY IN PATIENTS AFTER ACUTE CORONARY SYNDROME

    Directory of Open Access Journals (Sweden)

    A. V. Rudakova

    2015-09-01

    Full Text Available Dual antiplatelet therapy, including clopidogrel and aspirin, in a significant share of patients after acute coronary syndrome (ACS is characterized by high level of platelet reactivity, which is associated with an increased incidence of cardiovascular events. Perhaps it will make reasonable the prescription of new antiplatelet drugs, particularly the combination of ticagrelor with aspirin.Aim. To assess the cost-effectiveness of VerifyNow P2Y12 platelet reactivity testing in patients after ACS.Material and methods. The analysis was performed for patients aged 55 years after ACS by modeling based on the results of the PLATO trial considering Russian epidemiological data. The time horizon of simulation was 5 years. It was assumed that the patients were receiving either generic clopidogrel or ticagrelor for 1 year, or before maintenance treatment VerifyNow P2Y12 assay had been performed, and the patients with platelet reactivity index >230 24-48 hours after ACS were receiving ticagrelor and the remaining patients - generic clopidogrel. It was expected that after 1 year the patients would discontinue treatment with clopidogrel or ticagrelor, and hereafter additional therapeutic effect of their use would be absent. The costs of antiplatelet agents in the reference case corresponded to the weighted average price of public procurement in 2013 in Russia. The costs of treatment of complications corresponded to the compulsory health insurance rates for St. Petersburg in 2014. The cost and life expectancy were discounted at 3.5% per year.Results. The platelet reactivity test and the prescription by its results of the combination of clopidogrel plus aspirin or ticagrelor plus aspirin can prevent 5 myocardial infarction and 6 deaths per 1000 patients additionally as compared with the prescription of clopidogrel plus aspirin combination to all patients. The costs for one additional year of life as compared with the combination of clopidogrel plus aspirin

  7. Antiplatelet therapy in the primary prevention of cardiovascular disease in patients with chronic obstructive pulmonary disease: protocol of a randomised controlled proof-of-concept trial (APPLE COPD-ICON 2).

    Science.gov (United States)

    Kunadian, Vijay; Chan, Danny; Ali, Hani; Wilkinson, Nina; Howe, Nicola; McColl, Elaine; Thornton, Jared; von Wilamowitz-Moellendorff, Alexander; Holstein, Eva-Maria; Burns, Graham; Fisher, Andrew; Stocken, Deborah; De Soyza, Anthony

    2018-05-26

    The antiplatelet therapy in the primary prevention of cardiovascular disease in patients with chronic obstructive pulmonary disease (APPLE COPD-ICON2) trial is a prospective 2×2 factorial, double-blinded proof-of-concept randomised controlled trial targeting patients with chronic obstructive pulmonary disease (COPD) at high risk of cardiovascular disease. The primary goal of this trial is to investigate if treatment with antiplatelet therapy will produce the required response in platelet function measured using the Multiplate test in patients with COPD. Patients with COPD are screened for eligibility using inclusion and exclusion criteria. Eligible patients are randomised and allocated into one of four groups to receive aspirin plus placebo, ticagrelor plus placebo, aspirin plus ticagrelor or placebo only. Markers of systemic inflammation, platelet reactivity, arterial stiffness, carotid intima-media thickness (CIMT), lung function and quality of life questionnaires are assessed. The primary outcome consists of inhibition (binary response) of aspirin and ADP-induced platelet function at 6 months. Secondary outcomes include changes in inflammatory markers, CIMT, non-invasive measures of vascular stiffness, quality of life using questionnaires (EuroQol-five dimensions-five levels of perceived problems (EQ5D-5L), St. George's COPD questionnaire) and to record occurrence of repeat hospitalisation, angina, myocardial infarction or death from baseline to 6 months. Safety outcomes will be rates of major and minor bleeding, forced expiratory volume in 1 s, forced vital capacity and Medical Research Council dyspnoea scale. The study was approved by the North East-Tyne and Wear South Research Ethics Committee (15/NE/0155). Findings of the study will be presented in scientific sessions and published in peer-reviewed journals. ISRCTN43245574; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights

  8. Advances in Clinical Cardiology 2016: A Summary of the Key Clinical Trials.

    Science.gov (United States)

    Gray, Alastair; McQuillan, Conor; Menown, Ian B A

    2017-07-01

    The findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016. The authors reviewed clinical trials presented at major cardiology conferences during 2016 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), European Association for the Study of Diabetes (EASD), Transcatheter Cardiovascular Therapeutics (TCT), and the American Heart Association (AHA). Selection criteria were trials with a broad relevance to the cardiology community and those with potential to change current practice. A total of 57 key cardiology clinical trials were identified for inclusion. Here we describe and place in clinical context the key findings of new data relating to interventional and structural cardiology including delayed stenting following primary angioplasty, contrast-induced nephropathy, management of jailed wires, optimal duration of dual antiplatelet therapy (DAPT), stenting vs bypass for left main disease, new generation stents (BioFreedom, Orsiro, Absorb), transcatheter aortic valve implantation (Edwards Sapien XT, transcatheter embolic protection), and closure devices (Watchman, Amplatzer). New preventative cardiology data include trials of bariatric surgery, empagliflozin, liraglutide, semaglutide, PCSK9 inhibitors (evolocumab and alirocumab), and inclisiran. Antiplatelet therapy trials include platelet function monitoring and ticagrelor vs clopidogrel for peripheral vascular disease. New data are also presented in fields of heart failure (sacubitril/valsartan, aliskiren, spironolactone), atrial fibrillation (rivaroxaban in patients undergoing coronary intervention, edoxaban in DC cardioversion), cardiac devices (implantable cardioverter

  9. Clinical Trials

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    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

  10. Androgynes et gynandres : la relecture péladanienne du Banquet de Platon // Androgynes and gynandres : The Péladan’s reinterpretation of the Symposium by Plato

    OpenAIRE

    Eva Voldřichová Beránková

    2015-01-01

    The Symposium alias The Banquet belongs to those hypotexts by Plato which have been constantly reread and reinterpreted by the authors of French decadence. This article is focused on the Péladan’s reinterpretation of one of its parts, the famous Aristophanes’s speech about love. It implies on one hand the masculine notion of “androgyne”, heavily valorised in the fin de siècle novels, and, on the other hand, the feminine concept of “gynandre”, perceived negatively, feared and mocke...

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    Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

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  19. LAS CRÍTICAS DE ARISTÓTELES A PLATÓN EN METAFÍSICA I, 9 ARISTOTLE’S CRITICISMS OF PLATO IN METAPHYSICS I, 9

    Directory of Open Access Journals (Sweden)

    Silvana Gabriela Di Camillo

    2011-03-01

    Full Text Available

    O recurso à exposição crítica das doutrinas anteriores é um procedimento metodológico usual em Aristóteles. Mas a característica distintiva do Livro I da Metafísica é que, ao invés de estabelecer uma nova doutrina, o exame dos predecessores serve para confirmar os próprios conceitos aristotélicos, os quais ele usa para avaliar os êxitos e os erros das doutrinas analisadas. Essa imposição de conceitos próprios lhe valeu a acusação de ter uma compreensão histórica distorcida. Com a análise detalhada das críticas da teoria platônica das Idéias na Metafísica I, 9, pretendemos mostrar: a que as críticas de manipulação e distorção das opiniões dos seus antecessores ofuscam o grau em que as suas próprias posições emergem de uma análise crítica do pensamento anterior; e b que a imposição de conceitos próprios não é uma distorção, mas uma proposta de solução para os problemas que as teorias anteriores deixaram sem solução.

    The use of critical exposition of previous doctrines is a methodological procedure usual in Aristotle. But the distinctive characteristic of Book I of the Metaphysics is that, rather than to establish a new doctrine, a review of  predecessors serves to confirm the own concepts to be used in the evaluation of the doctrines examined. This imposition of own terms has cost him the charge of distorting historical understanding. With the detailed analysis of the criticisms of Plato's theory of Ideas in Metaphysics I, 9, we intend to show a that the criticism of manipulation and distortion of his predecessors' views overshadow the degree to which Aristotle's own positions emerge from a critical review of previous thought and b that the

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    Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

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  13. Androgynes et gynandres : la relecture péladanienne du Banquet de Platon // Androgynes and gynandres : The Péladan’s reinterpretation of the Symposium by Plato

    Directory of Open Access Journals (Sweden)

    Eva Voldřichová Beránková

    2015-12-01

    Full Text Available The Symposium alias The Banquet belongs to those hypotexts by Plato which have been constantly reread and reinterpreted by the authors of French decadence. This article is focused on the Péladan’s reinterpretation of one of its parts, the famous Aristophanes’s speech about love. It implies on one hand the masculine notion of “androgyne”, heavily valorised in the fin de siècle novels, and, on the other hand, the feminine concept of “gynandre”, perceived negatively, feared and mocked. Why in Péladan’s (1858–1918 eyes and according to many others decadent authors man is gorgeous and intelligent enough to realize on his own the platonic ideal of the union of the two sexes? And what about the woman, henceforth outmoded and “useless”? The decadent misogyny ties itself in knots over its fanciful theories which are reflective of the spirit of this historical period.

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    Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

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    Full Text Available ... people who fit the patient traits for that study (the eligibility criteria). Eligibility criteria differ from trial to trial. They include factors such as a patient's age and gender, the type and stage of disease, and whether ...

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    Full Text Available ... risks that outweigh any possible benefits. Clinical Trial Phases Clinical trials of new medicines or medical devices are done in phases. These phases have different purposes and help researchers ...

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  3. Paramenide e Platone (e Aristotele nel Contre Colote de Plutarque Parménide et Platon (et Aristote dans le Contre Colotès de Plutarque Parmenides and Plato (and Aristote in Plutarch'sAgainst Colotes

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    2013-05-01

    Full Text Available The chapters dedicated to Parmenides and Plato play a decisive role in the composition strategy of the Adversus Colotem, since this is where Plutarch most clearly defines the background dualist thesis that will help demonstrate that Platonism is superior to Epicurism. By showing Parmenides too as a dualist engaged in distinguishing between the sensible and the intelligible world, Plutarch structures a history of ancient philosophy entirely focused on Plato. These chapters also bear witness of another centre of interest, namely Aristoteles (§ 14, who, despite the criticism he aimed at the theory of ideas, is not completely refuted, but rather used as a possible ally against epicurean materialists, Plutarch’s true bête noire.Les chapitres consacrés à Parménide et Platon jouent un rôle décisif dans la stratégie de composition de l’Adversus Colotem : c’est là en effet que Plutarque définit de la manière la plus claire la thèse dualiste de fond qui va servir à démontrer la supériorité du platonisme sur l’épicurisme. En présentant Parménide lui aussi comme un dualiste occupé à distinguer entre monde sensible et monde intelligible, Plutarque articule une histoire de la philosophie antique entièrement centrée sur Platon. Les chapitres témoignent ensuite d’un autre centre d’intérêt, avec la mention d’Aristote (§ 14, lequel, malgré les critiques qu’il adresse à la théorie des idées, n’est pas complètement réfuté, mais plutôt utilisé comme un allié possible contre les matérialistes épicuriens, la véritable « bête noire » de Plutarque.I capitoli dedicati a Parmenide e Platone giocano un ruolo decisivo nella strategia compositiva dell’Adversus Colotem: è qui infatti che Plutarco delinea nel modo più chiaro la tesi dualistica di fondo che servirà a dimostrare la superiorità del platonismo sull’epicureismo. Presentando anche Parmenide come un dualista, impegnato a distinguere tra mondo

  4. Alternativa de protección contra la corrosión del acero AISI 310S mediante recubrimiento de aluminio bajo condiciones de platos separadores en celdas de combustible de carbonatos fundidos

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    R. Orozco-Cruz

    2016-01-01

    Full Text Available Introducción: La celda de combustible de carbonatos fundidos (MCFC, por sus siglas en inglés convencional opera a 650°C. Consiste de un cátodo de NiO poroso y litiado, una mezcla eutéctica de carbonato de litio (Li2CO3 y carbonato de potasio (K2CO3 fundido en una matriz electrolitica de óxido de aluminio litiado (LiAlO2 y un ánodo poroso de Ni. Los platos separadores entre cada celda presentan problemas de corrosión. Ante eso, un acero inoxidable AISI 310S con recubrimiento fue estudiado en condiciones de un plato separador en una MCFC. Método: Se utilizó un acero inoxidable AISI 310S como sustrato (muestra A, aplicándole un recubrimiento de Al con (B y sin tratamiento térmico (C. Fueron expuestos en carbonatos fundidos (62 mol% Li2CO3 -38 mol% K2CO3 a 650 °C en crisoles de alúmina. El comportamiento electroquímico fue estudiado mediante la técnica de Espectroscopía de Impedancia Electroquimica (EIS. Para el análisis de los diagramas de impedancia, se utilizó el software de simulación “Boukamp Equivalent Circuit”. La sección transversal de las muestras corroídas fue caracterizada mediante Microscopía Electrónica de Barrido (SEM, por sus siglas en inglés y los productos formados por Difracción de rayos X (XRD, por sus siglas en inglés. Resultados: Los diagramas de EIS presentan aumentos y disminuciones en los semicírculos formados a altas frecuencias indicativo de disolución de la capa externa, aumento y disminución de la resistencia de esta última así como el posible rompimiento de ella. La técnica de XRD presentó fases LiFeO2, LiCrO2, -LiAlO2 y -LiAlO2 así como fases intermetálicas para las distintas condiciones de la muestra. De la misma manera, los análisis de SEM presentaron los espesores de cada una de las capas formadas. Discusión o Conclusión: En la muestra A, se formaron capas de LiFeO2 y LiCrO2 después de 200 horas de exposición. La capa de LiCrO2 aumenta por la difusión de Li hacia el

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  6. Clinical Trials

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    Full Text Available ... Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ...

  7. Clinical Trials

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    Full Text Available ... and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense ... FOIA) Accessibility Copyright and Usage No FEAR Act Grants and Funding Building 31 31 Center Drive Bethesda, ...

  8. Clinical Trials

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    Full Text Available ... to preexisting differences between the patients. Usually, a computer program makes the group assignments. Masking The term " ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ...

  9. Clinical Trials

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    Full Text Available ... as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes ... for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

  10. Clinical Trials

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    Full Text Available ... treatment of menopausal symptoms. It also was increasingly being used for prevention of heart disease.) The study ... a trial are due to the different strategies being used, not to preexisting differences between the patients. ...

  11. Clinical Trials

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    Full Text Available ... combination of estrogen and progestin, the risk of breast cancer also increased. As a result, the U.S. Food ... to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants often were ...

  12. Clinical Trials

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    Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. ( ...

  13. Clinical Trials

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    Full Text Available ... Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A- ... assumed that trial results were valid for other populations as well. Researchers now realize that women and ...

  14. Clinical Trials

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    Full Text Available ... always, parents must give legal consent for their child to take part in a clinical trial. When ... minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  15. La Traditio Legis de Cristo a Pedro y Pablo en un plato de vidrio de Cástulo, Linares (Jaén = Traditio Legis of Christ to Peter and Paul in a glass bowl from Cástulo, Linares (Jaén

    Directory of Open Access Journals (Sweden)

    José Mª Blázquez

    2016-04-01

    Full Text Available En este artículo analizamos la iconografía de un plato de vidrio encontrado en Cástulo con la representación de la Tradicio legis o transmisión de la ley de Cristo a los apóstoles Pedro y Pablo.In this paper we analyze the iconography of a glass bowl found in Cástulo showing the representation of the Traditio legis, or «transmission of the law» of Christ to apostles Peter and Paul.

  16. Breads, loaves and portable stoves. Two ceramic forms intended for the baking of bread in Al-Andalus: the stove (tannur and the dish (tabag | Panes, hogazas y fogones portátiles. Dos formas cerámicas destinadas a la cocción del pan en Al-Andalus: el hornillo (tannur y el plato (tabag

    Directory of Open Access Journals (Sweden)

    Sonia Gutiérrez Lloret

    1991-12-01

    Full Text Available With this work we want to identify several pottery's series found in rural archaeological sequences of the Middle Ages beginning from the Eastern part of the Iberian Peninsula with two portable methode for bread-baking —the portable furnace or tannur and the baking-plate or tabaq— cited in the literary Arabian sources, contrasting with similar objects quoted by Latin and visigothics sources. This study includes also their origin and perdurance but, whereas these baking-plate appear in the Late Roman baking technology, the portable furnace was, apparently, introduced in al-Andalus with the Islamic conquest. | En este trabajo pretendemos identificar diversos repertorios cerámicos aparecidos en contextos arqueológicos altomedievales rurales del levante peninsular, con dos sistemas portátiles de coción del pan —el hornillo o tannur y el plato o tabaq— mencionados en las fuentes literarias árabes, relacionándolos, en algunos casos, con objetos similares mencionados en las fuentes latinas y visigodas. Estudiamos también sus orígenes y perduraciones, pero mientras que el plato figura en las tradiciones tardorromanas de panificación, el hornillo, de tradición semita, parece ser introducido en al-Andalus con la conquista islámica.

  17. Text messaging reminders for influenza vaccine in primary care: protocol for a cluster randomised controlled trial (TXT4FLUJAB).

    Science.gov (United States)

    Herrett, Emily; van Staa, Tjeerd; Free, Caroline; Smeeth, Liam

    2014-05-02

    The UK government recommends that at least 75% of people aged under 64 with certain conditions receive an annual influenza vaccination. Primary care practices often fall short of this target and strategies to increase vaccine uptake are required. Text messaging reminders are already used in 30% of practices to remind patients about vaccination, but there has been no trial addressing their effectiveness in increasing influenza vaccine uptake in the UK. The aims of the study are (1) to develop the methodology for conducting cluster randomised trials of text messaging interventions utilising routine electronic health records and (2) to assess the effectiveness of using a text messaging influenza vaccine reminder in achieving an increase in influenza vaccine uptake in patients aged 18-64 with chronic conditions, compared with standard care. This cluster randomised trial will recruit general practices across three settings in English primary care (Clinical Practice Research Datalink, ResearchOne and London iPLATO text messaging software users) and randomise them to either standard care or a text messaging campaign to eligible patients. Flu vaccine uptake will be ascertained using routinely collected, anonymised electronic patient records. This protocol outlines the proposed study design and analysis methods. This study will determine the effectiveness of text messaging vaccine reminders in primary care in increasing influenza vaccine uptake, and will strengthen the methodology for using electronic health records in cluster randomised trials of text messaging interventions. This trial was approved by the Surrey Borders Ethics Committee (13/LO/0872). The trial results will be disseminated at national conferences and published in a peer-reviewed medical journal. The results will also be distributed to the Primary Care Research Network and to all participating general practices. This study is registered at controlled-trials.com ISRCTN48840025, July 2013.

  18. Clinical Trials

    Medline Plus

    Full Text Available ... an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment team. ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... taking the same treatment the same way. These patients are closely watched by Data and Safety Monitoring Boards. Even if you don't directly ... risk procedures (such as gene therapy) or vulnerable patients (such as ... trial for safety problems or differences in results among different groups. ...

  20. The Trial

    Science.gov (United States)

    Bryant, Jen

    2004-01-01

    Growing up in Flemington, New Jersey, put Jen Bryant in the heart of the lore behind the Lindbergh baby kidnapping. Family stories of the events of the day and extensive research led to "The Trial," a novel in verse. The first several parts of this novel are included here.

  1. Clinical Trials

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ...

  2. Clinical Trials

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    Full Text Available ... treatments produce better results for certain illnesses or groups of people; look at the best age and frequency for doing screening tests, such as mammography; and compare two or more screening tests to see which test ... Some companies and groups sponsor clinical trials that test the safety of ...

  3. Clinical Trials

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    Full Text Available ... patient has had certain treatments or has other health problems. Eligibility criteria ensure that new approaches are tested ... public. What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ...

  4. Clinical Trials

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    Full Text Available ... This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ...

  5. Clinical Trials

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    Full Text Available ... edge approaches, such as gene therapy or new biological treatments. Health insurance and health care providers don't ... of a trial, early if the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and ...

  6. Clinical Trials

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    Full Text Available ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the ...

  7. Clinical Trials

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    Full Text Available ... to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep Science and ...

  8. Clinical Trials

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    Full Text Available ... protect patients and help produce reliable study results. Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ...

  9. Clinical Trials

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    Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part ... about how you feel. Some people will need to travel or stay in hospitals ...

  10. Clinical Trials

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    Full Text Available ... Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ... Activity Population and Epidemiology Studies Women’s Health All Science A-Z Grants ... in the Press Research Features All Events Past Events Upcoming ...

  11. Clinical Trials

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    Full Text Available ... safe a treatment is or how well it works. Children (aged 18 and younger) get special protection as research subjects. Almost always, parents must give legal consent for their child to take part in a clinical trial. When ...

  12. Clinical Trials

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    Full Text Available ... As a result, the U.S. Food and Drug Administration now recommends never using HT to prevent heart disease. When HT is used for menopausal symptoms, it should be taken only at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ...

  13. Clinical Trials

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... include factors such as a patient's age and gender, the type and stage of disease, ... helps ensure that any differences observed during a trial are due to the ...

  14. Clinical Trials

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    Full Text Available ... an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  15. Clinical Trials

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    Full Text Available ... Wide Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

  16. Clinical Trials

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    Full Text Available ... approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients to find out whether a ...

  17. Textbook of clinical trials

    National Research Council Canada - National Science Library

    Day, Simon; Machin, David; Green, Sylvan B

    2006-01-01

    ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 The Development of Clinical Trials Simon...

  18. Plato: White and Non-white Love

    Directory of Open Access Journals (Sweden)

    Amo Sulaiman

    2009-06-01

    Full Text Available Plato’s dialogues, the Symposium, and Phaedrus, provide a reasonableexplanation of love. G. Vlastos and M. Nussbaum do not share such anopinion. The former contends that Plato’s view of love is about lovingonly a person’s beauty, but not the entire person; thus, it falls short of anappropriate explanation of love. The latter holds that a theory of love should be complete, and that Plato’s one is incomplete on the grounds that it does not account for personal love. These criticisms will be re-evaluated in light of the duality of love (the white and non-white horses—in Phaedrus as well as participants’ views in the Symposium; a re-assessment will weaken the mentioned objections. This paper contends that from the Symposium and Phaedrus, one can have a fruitful understanding of being in love, being out of love, falling inlove, loving for its own sake and being erotically in love. In order to account for these related issues of love it is important to consider Plato’s works in terms of his “official” and “unofficial” views. The former is construed as the doctrine of the lover or loving for its own sake: this is associates with Diotima’s views which are repeated by Socrates. With reference to the latter, it is possible to explain what personal love or being in love, being out of love, falling in love, and being erotically in love involve. Erotic love will be interpreted as an extension of our philosophical conception of love, related to views of love that are mentioned in the Symposium other than Socrates’ report of Diotima’s conceptions. This paper is divided into two parts: the first one will show views of love in the Symposium. That is, being in love, being out of love, falling in love and loving for its own sake will be discussed. In addition, the forementioned criticisms will be re-evaluated. In the second section, we will show that Aristophanes’ speech expresses erotic love, and then Kant’s objections will be explained and discussed.

  19. Aristotle vs. Plato: The Balkans' Paradoxical Enlightenment

    Directory of Open Access Journals (Sweden)

    D. Michalopoulos

    2007-09-01

    Full Text Available As it occurred in West, Aristotle’s thought was in Byzantium the main organon of philosophical meditation within the frame of the Christian Faith. Nonetheless, from the ninth century on it was a revival of Platonism that took place – of Neo-Platonism at the beginning and of Platonism itself at the end. The Church, initially indifferent, became suspicious only when, at the turning of the fourteenth to the fifteenth century, the Platonism seemed to engender somewhat a latent paganism; but the Patriarchate was not then able to fight that tendency. So only after the 1453 capture of Constantinople by the Ottomans, Gennadius Scholarius managed to root out from the Greek lands Platonism and its crypto-pagan extension. Be that as it may; the main paradox of the Balkan history is that in the early seventeenth century some leading Greek scholars endorsed the materialist interpretation of Aristotle’s thought – as it was taught in the University of Padua by Cesare Cremonini; and as a corollary this materialistic philosophical system began being taught in both Constantinople and Athens. It was that very way that the Enlightenment took birth in the Balkans – and somehow became a State ideology - long before its prevalence in France. And of course all this had as a result a turn toward Physics and Chemistry with far-reaching consequences

  20. Types of Cancer Clinical Trials

    Science.gov (United States)

    Information about the several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, supportive and palliative care trials. Each type of trial is designed to answer different research questions.

  1. Platón ako Pseudo-Sókratés? Niekoľko poznámok k problematike autorstva filozofického textu v antike ( “Plato as Pseudo-Socrates? Some Remarks on the Problems Related to the Autorship of a Philosophical Text in Antiquity“

    Directory of Open Access Journals (Sweden)

    František Škvrnda ml.

    2017-12-01

    Full Text Available The following paper deals with the problematic category of authorship in ancient philosophical literature. Philosophers are divided into two groups: the first consist of non-writing protagonists (e. g. Socrates, Ammonius of Saccas, while the second category includes writing authors (e. g. Plato, Aristotle. Paper argues that with regard to their „historicity“, between these two groups of philosophers is no substantial difference. Philosophical texts were often written in co-authorship. Many students and later adherents passed their own doctrines off as teacherʼs originals. Moreover, due to the fact that the very texts were transcribed countless times, there is no certainty about original phrasing of the documents that came down to our modern or renaissance era. The „historicity“ of philosophersʼ attitudes and ideas therefore can not be deduced from the existence of authorized text, written by some particular author.

  2. On-treatment platelet reactivity: State of the art and perspectives.

    Science.gov (United States)

    Marcucci, Rossella; Grifoni, Elisa; Giusti, Betti

    2016-02-01

    High on-clopidogrel platelet reactivity (HcPR) during dual-antiplatelet therapy is a marker of vascular risk, in particular stent thrombosis, in patients with acute coronary syndromes (ACS). Genetic determinants (CYP2C19*2 polymorphism), advanced age, female gender, diabetes and reduced ventricular function are related to a higher risk to develop HcPR. In addition, inflammation and increased platelet turnover, as revealed by the elevated percentage of reticulated platelets in patients' blood, that characterize the acute phase of acute coronary syndromes, are associated with HcPR. To overcome the limitation of clopidogrel, new antiplatelet agents (prasugrel and ticagrelor) were developed and the demonstration of their superiority over clopidogrel was obtained in the two randomized trials, TRITON TIMI 38 and PLATO. Emerging evidence is accumulating on the role of high-on aspirin platelet reactivity (HaPR), especially in the clinical context of diabetes. Finally, the presence of new, potent antiplatelet drugs has shifted the focus from thrombotic to bleeding risk. Recent data document that low on-treatment platelet reactivity (LPR) is associated with a significantly higher bleeding risk. Due to the current possibility to choose between multiple antiplatelet strategies, the future perspective is to include in the management of ACS, in addition to clinical data and classical risk factors, the definition of platelet function during treatment in order to set a tailored therapy. Copyright © 2015 Elsevier Inc. All rights reserved.

  3. Understanding Clinical Trials

    Science.gov (United States)

    Watch these videos to learn about some basic aspects of cancer clinical trials such as the different phases of clinical trials, methods used to protect patient safety, and how the costs of clinical trials are covered.

  4. Clinical trials of homoeopathy.

    Science.gov (United States)

    Kleijnen, J; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

  5. Managing clinical trials

    Directory of Open Access Journals (Sweden)

    Kenyon Sara

    2010-07-01

    Full Text Available Abstract Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.

  6. Remune trial will stop; new trials planned.

    Science.gov (United States)

    James, J S

    1999-05-21

    A clinical trial using remune, the anti-HIV vaccine developed by the late Dr. Jonas Salk, has been ended. The study is a clinical-endpoint trial which looks for statistically significant differences in AIDS sickness or death between patients who add remune to their treatment regimens versus those who use a placebo. Agouron Pharmaceuticals and the Immune Response Corporation who were conducting the trial announced their decision to stop it after an analysis by the Data Safety Monitoring Board. No differences in clinical endpoints were found and it was projected that continuing the trial would likely not find any. The companies are now planning two new Phase III trials using viral load testing rather than clinical endpoints as study criteria.

  7. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  8. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    "Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide...

  9. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... and Public Home » Hepatitis C » Treatment Decisions Viral Hepatitis Menu Menu Viral Hepatitis Viral Hepatitis Home For ... can I find out about participating in a hepatitis C clinical trial? Many trials are being conducted ...

  10. Understanding noninferiority trials

    Directory of Open Access Journals (Sweden)

    Seokyung Hahn

    2012-11-01

    Full Text Available Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

  11. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    ... in the pharmaceutical industry, Clinical trial methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research...

  12. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...

  13. Conducting clinical trials in Singapore.

    Science.gov (United States)

    Woo, K T

    1999-04-01

    All clinical trials in Singapore will now have to conform to the Medicines (Clinical Trials) Amended Regulations 1998 and the Singapore Good Clinical Practice (GCP) Guidelines 1998. The Medical Clinical Research Committee (MCRC) has been established to oversee the conduct of clinical drug trials in Singapore and together with the legislations in place, these will ensure that clinical trials conducted in Singapore are properly controlled and the well-being of trial subjects are safe guarded. All clinical drug trials require a Clinical Trial Certificate from the MCRC before the trial can proceed. The hospital ethics committee (EC) vets the application for a trial certificate before it is sent to MCRC. The drug company sponsoring the trial has to indemnify the trial investigators and the hospital for negligence arising from the trial. The MCRC, apart from ensuring the safety of trial subjects, has to provide continuing review of the clinical trial and monitors adverse events in the course of the trial. The EC will conduct continuing review of clinical trials. When a non-drug clinical trial is carried out, the EC will ensure that the proposed protocol addresses ethical concerns and meets regulatory requirements for such trials. There is great potential for pharmaceutical Research & Development (R&D) in Singapore. We must develop our skills and infrastructure in clinical trials to enable Singapore to be a regional hub for R&D of drugs in Asia.

  14. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  15. Update on TROG trials

    International Nuclear Information System (INIS)

    Joseph, D.

    2001-01-01

    Full text: Validation of treatment methodologies can only be achieved in the context of unambiguous, efficiently managed, randomised and controlled clinical trials. Since 1991, the Trans-Tasman Radiation Oncology Group (TROG) has coordinated over 29 protocols in radiation oncology, including several key randomised controlled trials. The impetus behind TROG is the establishment of an evidence base for particular approaches to radiotherapy and its adjunct use with alternative and complementary treatment methods. As the level of technology incorporated into radiotherapy continues to increase, as the need for improved accuracy in dose assessment increases and as the requirements of realistic quality assurance (QA) for clinical trials becomes more demanding it is imperative that all professionals involved in radiotherapy, including physicists, become actively involved in the QA of trials. This is particularly important for large scale multi-centre trials which intend to prove the benefits of particular treatment approaches on a national or international stage rather then in the context of a single clinic. This talk will: 1. Examine the outcomes of TROG trials to date in terms of the information obtained. 2. Briefly consider current and impending TROG trials and their requirements in terms of clinical and physics input. 3. Examine the results of international clinical trials in terms of the influence they have had on radiotherapy practice and health outcomes, and the advantages they have obtained by consistent co-operation between clinical and technological staff. 4. Consider the benefits of multi-centre clinical trials and the QA controls that are necessary to ensure accuracy of resulting recommendations. Copyright (2001) Australasian College of Physical Scientists and Engineers in Medicine

  16. Opioid analgesics-related pharmacokinetic drug interactions: from the perspectives of evidence based on randomized controlled trials and clinical risk management

    Directory of Open Access Journals (Sweden)

    Feng XQ

    2017-05-01

    Full Text Available Xiu-qin Feng,1 Ling-ling Zhu,2 Quan Zhou3 1Nursing Administration Office, Division of Nursing, 2VIP Care Ward, Division of Nursing, 3Department of Pharmacy, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, People’s Republic of China Background: Multimorbidity results in complex polypharmacy which may bear a risk of drug interactions. A better understanding of opioid analgesics combination therapy used for pain management could help warrant medication safety, efficacy, and economic relevance. Until now there has been no review summarizing the opioid analgesics-related pharmacokinetic drug interactions from the perspective of evidence based on randomized controlled trials (RCTs. Method: A literature search was performed using PubMed, MEDLINE, and the Cochrane Library, using a PRISMA flowchart. Results: Fifty-two RCTs were included for data interpretation. Forty-two RCTs (80.8% were conducted in healthy volunteers, whereas 10 RCTs (19.2% enrolled true patients. None of the opioid–drug/herb pairs was listed as contraindications of opioids involved in this review. Circumstances in which opioid is comedicated as a precipitant drug include morphine–P2Y12 inhibitors, morphine–gabapentin, and methadone–zidovudine. Circumstances in which opioid is comedicated as an object drug include rifampin–opioids (morphine, tramadol, oxycodone, methadone, quinidine–opioids (morphine, fentanyl, oxycodone, codeine, dihydrocodeine, methadone, antimycotics–opioids (buprenorphine, fentanyl, morphine, oxycodone, methadone, tilidine, tramadol, protease inhibitors–opioids (ritonavir, ritonavir/lopinavir–oxycodone, ritonavir–fentanyl, ritonavir–tilidine, grapefruit juice–opioids (oxycodone, fentanyl, methadone, antidepressants–opioids (paroxetine–tramadol, paroxetine–hydrocodone, paroxetine–oxycodone, escitalopram–tramadol, metoclopramide–morphine, amantadine–morphine, sumatriptan

  17. ClinicalTrials.gov

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  18. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For eac...

  19. Cancer clinical trials

    International Nuclear Information System (INIS)

    Scheurlen, A.; Kay, R.; Baum, M.

    1988-01-01

    This book contains the proceedings on Cancer clinical trials: A critical appraisal. Topics covered include: Scientific fundamentals; Heterogeneous treatment effects; On combining information: Historical controls, overviews, and comprehensive cohort studies; and assessment of quality of life

  20. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity....... In order to overcome these various types of heterogeneity and to compare like with like, the treatment comparison should be stratified a posteriori by question (i.e., type of castration or type of anti-androgen studied) and by study. In this way, one may draw valid conclusions. Of course, those trials...

  1. Falsificationism and clinical trials.

    Science.gov (United States)

    Senn, S J

    1991-11-01

    The relevance of the philosophy of Sir Karl Popper to the planning, conduct and analysis of clinical trials is examined. It is shown that blinding and randomization can only be regarded as valuable for the purpose of refuting universal hypotheses. The purpose of inclusion criteria is also examined. It is concluded that a misplaced belief in induction is responsible for many false notions regarding clinical trials.

  2. The OA Trial Bank

    DEFF Research Database (Denmark)

    van Middelkoop, Marienke; Arden, N K; Atchia, I.

    2016-01-01

    Objective: To evaluate the efficacy of intra-articular (IA) glucocorticoids for knee or hip osteoarthritis (OA) in specific subgroups of patients with severe pain and inflammatory signs using individual patient data (IPD) from existing trials. Design: Randomized trials evaluating one or more IA...... glucocorticoid preparation in patients with knee or hip OA, published from 1995 up to June 2012 were selected from the literature. IPD obtained from original trials included patient and disease characteristics and outcomes measured. The primary outcome was pain severity at short-term follow-up (up to 4 weeks...... Interval 1.50-26.31) when receiving IA glucocorticoid injection compared to placebo. No statistical significant interaction effects were found between inflammatory signs and IA glucocorticoid injections compared to placebo and to tidal irrigation at all follow-up points. Conclusions: This IPD meta...

  3. The CYTONOX trial

    DEFF Research Database (Denmark)

    Gade, Christina; Mikus, Gerd; Christensen, Hanne Rolighed

    2016-01-01

    INTRODUCTION: In Denmark, it is estimated that 3-5% of children are obese. Obesity is associated with pathophysiological alterations that may lead to alterations in the pharmacokinetics of drugs. In adults, obesity was found to influence important drug-metabolising enzyme pathways. The impact...... of obesity-related alterations on drug metabolism and its consequences for drug dosing remains largely unknown in both children and adults. An altered drug metabolism may contribute significantly to therapeutic failure or toxicity. The aim of this trial is to investigate the in vivo activity of CYP3A4, CYP2E......1 and CYP1A2 substrates in obese versus non-obese children. METHODS: The CYTONOX trial is an open-label explorative pharmacokinetic trial. We intend to include 50 obese and 50 non-obese children. The primary end points are: in vivo clearance of CYP3A4, CYP2E1 and CYP1A2 substrates, which...

  4. The FOCUS trial

    DEFF Research Database (Denmark)

    Glenthøj, Louise B; Fagerlund, Birgitte; Randers, Lasse

    2015-01-01

    BACKGROUND: Cognitive deficits are a distinct feature among people at ultra-high risk (UHR) for psychosis and pose a barrier to functional recovery. Insufficient evidence exists on how to ameliorate these cognitive deficits in patients at UHR for psychosis and hence improve daily living and quality...... of life. The aim of the trial is to investigate whether cognitive remediation can improve cognitive and psychosocial function in patients at UHR for psychosis. METHODS: The FOCUS trial (Function and Overall Cognition in Ultra-high risk States) is a randomised, parallel group, observer-blinded clinical...... trial enrolling 126 patients meeting the standardised criteria of being at UHR for psychosis. Patients are recruited from psychiatric in- and outpatient facilities in the Copenhagen catchment area. Patients are randomised to one of the two treatment arms: cognitive remediation plus standard treatment...

  5. plato and the teaching of entrepreneurship studies as general

    African Journals Online (AJOL)

    JONATHAN

    2016-08-22

    Aug 22, 2016 ... curriculum and teaching of entrepreneurial studies in Universities? .... EMPLOYMENT: the public sector is still is still the largest employer of ..... This care of the body in the case of those who are to be guardians of the .... sponsors for such program. In ... Oguejiofor (eds) African Philosophy and Public Affairs.

  6. PPI, paradoxes and Plato: who's sailing the ship?

    Science.gov (United States)

    Ives, Jonathan; Damery, Sarah; Redwod, Sabi

    2013-03-01

    Over the last decade, patient and public involvement (PPI) has become a requisite in applied health research. Some funding bodies demand explicit evidence of PPI, while others have made a commitment to developing PPI in the projects they fund. Despite being commonplace, there remains a dearth of engagement with the ethical and theoretical underpinnings of PPI processes and practices. More specifically, while there is a small (but growing) body of literature examining the effectiveness and impact of PPI, there has been relatively little reflection on whether the concept/practice of PPI is internally coherent. Here, the authors unpick a 'paradox' within PPI, which highlights a tension between its moral and pragmatic motivations and its implementation. The authors argue that this 'professionalisation paradox' means we need to rethink the practice, and purpose, of PPI in research.

  7. Pragmatic Critique of Plato's Theory of Education | Umezurike ...

    African Journals Online (AJOL)

    ... of education which involves rigorous process and which he believed could help determine the class where each individual citizen could be grouped. This theory though very fantastic when examined theoretically, is not without some flaws. It is because of these flaws that some philosophers describe his theory as utopian.

  8. Rekindling the Dialogue: Education According to Plato and Dewey

    Science.gov (United States)

    Van Luchene, Stephen R.

    2004-01-01

    Since passage of the No Child Left Behind Act of 2001, thinking about America's schools has been taken over by something like philosopher Rene Descartes's malignant demon of doubt. The act's exclusive focus on assessing student achievement and faculty accountability in terms that can be "proved" mathematically has cast into doubt a…

  9. Plato and the art of leadership citizenship | Nwankwor | Sophia: An ...

    African Journals Online (AJOL)

    Sophia: An African Journal of Philosophy. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 10, No 2 (2008) >. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register. DOWNLOAD FULL TEXT Open Access ...

  10. "From Plato to Pareto": The Western Civilization Course Reconsidered.

    Science.gov (United States)

    Mullaney, Marie Marmo

    1986-01-01

    Discusses the importance of historical study within general education. Reviews the rise and fall of the Western Civilization course as the core of general education in the humanities. Suggests ways a revised version of this course can be restored to a central place in the curriculum. (AYC)

  11. Citizenship and Social Order: Reflections on Plato | Ogo ...

    African Journals Online (AJOL)

    Citoyenneté et ordre social: réflexions sur Platon Cet article traite de la relation entre ordre social citoyenneté et en s\\'inspirant de Platon. L\\'ordre social renvoie à des questions fondamentales de justice, de coopération entre les hommes et de recherche du bien commun. Il s\\'agit donc de savoir comment les responsabilités ...

  12. Plato, Socrates, Hunt, and Rotfeld: Eigenforms of Academic Collaboration

    Directory of Open Access Journals (Sweden)

    M Louise Ripley

    2011-10-01

    Full Text Available A number of academic institutions profess to offer Interdisciplinary Studies but few truly achieve it, and not without a great deal of effort over and above the normal workload of a professor and a level of patience and perseverance not found in many university students. This paper will report on a successful academic collaboration between two very different disciplines: philosophy and business. It will examine a course taught jointly by the two disciplines in a strategy of imbrication attempted by a college of York University in Toronto, Atkinson College, housing both liberal arts and professional school.

  13. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A; Smith, G

    2016-01-01

    of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. MethodsThis was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using...

  14. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...

  15. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.

    2015-01-01

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct...

  16. [Clinical trials in nursing journals].

    Science.gov (United States)

    Di Giulio, Paola; Campagna, Sara; Dimonte, Valerio

    2014-01-01

    Clinical trials are pivotal for the development of nursing knowledge. To describe the clinical trials published in nursing journals in the last two years and propose some general reflections on nursing research. A search with the key-word trial was done on PubMed (2009-2013) on Cancer Nursing, European Journal of Oncology Nursing, International Journal of Nursing Studies, Journal of Advanced Nursing, Journal of Clinical Nursing and Nursing Research. Of 228 trials identified, 104 (45.8%) were published in the last 2 years. Nurses from Asian countries published the larger number of trials. Educational and supportive interventions were the most studied (61/104 trials), followed by clinical interventions (33/104). Samples were limited and most trials are monocentric. A growing number of trials is published, on issues relevant for the nursing profession, however larger samples and multicentric studies would be necessary.

  17. The COLOFOL trial

    DEFF Research Database (Denmark)

    Hansdotter Andersson, Pernilla; Wille-Jørgensen, Peer; Horváth-Puhó, Erzsébet

    2016-01-01

    population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24......INTRODUCTION: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL...... participating centers, we scrutinized hospital inpatient data to identify all colorectal cancer patients who underwent surgery, in order to ascertain all eligible patients who were not included in the study and to compare them with enrolled patients. RESULTS: Of a total of 4,445 eligible patients, 2...

  18. Ethics of clinical trials.

    Science.gov (United States)

    Palter, S F

    1996-05-01

    The modern clinical trial is a form of human experimentation. There is a long history of disregard for individual rights of the patient in this context, and special attention must be paid to ethical guidelines for these studies. Clinical trials differ in basic ways from clinical practice. Foremost is the introduction of outside interests, beyond those of the patient's health, into the doctor-patient therapeutic alliance. Steps must be taken to protect the interests of the patient when such outside influence exists. Kantian moral theory and the Hippocratic oath dictate that the physician must respect the individual patient's rights and hold such interests paramount. These principles are the basis for informed consent. Randomization of patients is justified when a condition of equipoise exists. The changing nature of health care delivery in the United States introduces new outside interests into the doctor-patient relationship.

  19. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2007-12-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Intergrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 249553, 2-Methoxyestradiol; Abatacept, Adalimumab, Adefovir dipivoxil, Agalsidase beta, Albinterferon alfa-2b, Aliskiren fumarate, Alovudine, Amdoxovir, Amlodipine besylate/atorvastatin calcium, Amrubicin hydrochloride, Anakinra, AQ-13, Aripiprazole, AS-1404, Asoprisnil, Atacicept, Atrasentan; Belimumab, Bevacizumab, Bortezomib, Bosentan, Botulinum toxin type B, Brivaracetam; Catumaxomab, Cediranib, Cetuximab, cG250, Ciclesonide, Cinacalcet hydrochloride, Curcumin, Cypher; Darbepoetin alfa, Denosumab, Dihydrexidine; Eicosapentaenoic acid/docosahexaenoic acid, Entecavir, Erlotinib hydrochloride, Escitalopram oxalate, Etoricoxib, Everolimus, Ezetimibe; Febuxostat, Fenspiride hydrochloride, Fondaparinux sodium; Gefitinib, Ghrelin (human), GSK-1562902A; HSV-tk/GCV; Iclaprim, Imatinib mesylate, Imexon, Indacaterol, Insulinotropin, ISIS-112989; L-Alanosine, Lapatinib ditosylate, Laropiprant; Methoxy polyethylene glycol-epoetin-beta, Mipomersen sodium, Motexafin gadolinium; Natalizumab, Nimotuzumab; OSC, Ozarelix; PACAP-38, Paclitaxel nanoparticles, Parathyroid Hormone-Related Protein-(1-36), Pasireotide, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Picoplatin, Pimecrolimus, Pitavastatin calcium, Plitidepsin; Ranelic acid distrontium salt, Ranolazine, Recombinant human relaxin H2, Regadenoson, RFB4(dsFv)-PE38, RO-3300074, Rosuvastatin calcium; SIR-Spheres, Solifenacin succinate, Sorafenib, Sunitinib malate; Tadalafil, Talabostat, Taribavirin hydrochloride, Taxus, Temsirolimus, Teriparatide, Tiotropium bromide, Tipifarnib, Tirapazamine, Tocilizumab; UCN-01, Ularitide

  20. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2005-04-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort

  1. Clinical trials in India.

    Science.gov (United States)

    Maiti, Rituparna; M, Raghavendra

    2007-07-01

    The concept of outsourcing for the development and global studies on new drugs has become widely accepted in the pharmaceutical industry due to its cost and uncertainty. India is going to be the most preferred location for contract pharma research and development due to its huge treatment naïve population, human resources, technical skills, adoption/amendment/implementation of rules/laws by regulatory authorities, and changing economic environment. But still 'miles to go' to fulfill the pre-requisites to ensure India's success. In spite of all the pitfalls, the country is ambitious and optimist to attract multinational pharmaceutical companies to conduct their clinical trials in India.

  2. Clinical trials in dentistry in India: Analysis from trial registry.

    Science.gov (United States)

    Gowri, S; Kannan, Sridharan

    2017-01-01

    Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy

  3. Japan nuclear ship sea trial

    International Nuclear Information System (INIS)

    Yamazaki, Hiroshi; Kitamura, Toshikatus; Mizushima, Toshihiko

    1992-01-01

    The sea trial of the first Japan nuclear Ship 'MUTSU' was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author)

  4. [Maraviroc: clinical trials results].

    Science.gov (United States)

    Chidiac, C; Katlama, C; Yeni, P

    2008-03-01

    Just over a decade after identification of chemokine receptors CCR5 and CXCR4 as coreceptors for HIV, maraviroc (Celsentri), the first CCR5 antagonist, has recently obtained its Marketing Authorization in the United States and Europe, for treatment of treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable. CCR5 antagonists, after fusion inhibitor enfuvirtide available since 2003, also belong to entry inhibitors. These molecules, unlike previous antiretrovirals, do not target the virus but its target cell by blocking viral penetration. Maraviroc has shown its clinical efficacy in patients failing other antiretroviral classes. Its safety profile was similar to placebo in two large phase III trials. However, careful assessment of both hepatic and immunologic safety of this new therapeutic class is needed. Viral tropism testing has to be investigated before using maraviroc in the clinic, because CCR5 antagonists are not active against CXCR4 viruses. For the moment indicated for the treatment-experienced patient population, maraviroc could in the future benefit to other types of patients, depending on ongoing trials results.

  5. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2006-10-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issues focuses on the following selection of drugs: (-)-Epigallocatechin gallate, (-)-gossypol, 2-deoxyglucose, 3,4-DAP, 7-monohydroxyethylrutoside; Ad5CMV-p53, adalimumab, adefovir dipivoxil, ADH-1, alemtuzumab, aliskiren fumarate, alvocidib hydrochloride, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, amrubicin hydrochloride, AN-152, anakinra, anecortave acetate, antiasthma herbal medicine intervention, AP-12009, AP-23573, apaziquone, aprinocarsen sodium, AR-C126532, AR-H065522, aripiprazole, armodafinil, arzoxifene hydrochloride, atazanavir sulfate, atilmotin, atomoxetine hydrochloride, atorvastatin, avanafil, azimilide hydrochloride; Bevacizumab, biphasic insulin aspart, BMS-214662, BN-83495, bortezomib, bosentan, botulinum toxin type B; Caspofungin acetate, cetuximab, chrysin, ciclesonide, clevudine, clofarabine, clopidogrel, CNF-1010, CNTO-328, CP-751871, CX-717, Cypher; Dapoxetine hydrochloride, darifenacin hydrobromide, dasatinib, deferasirox, dextofisopam, dextromethorphan/quinidine sulfate, diclofenac, dronedarone hydrochloride, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Edaravone, efaproxiral sodium, emtricitabine, entecavir, eplerenone, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, etoricoxib, ezetimibe, ezetimibe/simvastatin; Finrozole, fipamezole hydrochloride, fondaparinux sodium, fulvestrant; Gabapentin enacarbil, gaboxadol, gefitinib, gestodene, ghrelin (human); Human insulin, human papillomavirus vaccine; Imatinib mesylate, immunoglobulin intravenous (human), indiplon, insulin detemir, insulin glargine, insulin glulisine, intranasal insulin, istradefylline, i.v. gamma

  6. Market trials of irradiated chicken

    International Nuclear Information System (INIS)

    Fox, John A.; Olson, Dennis G.

    1998-01-01

    The potential market for irradiated chicken breasts was investigated using a mail survey and a retail trial. Results from the mail survey suggested a significantly higher level of acceptability of irradiated chicken than did the retail trial. A subsequent market experiment involving actual purchases showed levels of acceptability similar to that of the mail survey when similar information about food irradiation was provided

  7. Defendants' Rights in Criminal Trials.

    Science.gov (United States)

    Martin, Ralph C., II; Keeley, Elizabeth

    1997-01-01

    Reviews the protections afforded by the Constitution for defendants in criminal trials. These include the right to a jury trial (in cases of possible incarceration), an impartial jury, and the requirement of a unanimous verdict. Defends the use of plea bargaining as essential to an efficient criminal justice system. (MJP)

  8. Cross-Over Clinical Trials?

    Directory of Open Access Journals (Sweden)

    Latif Gachkar

    2017-01-01

    Full Text Available Abstract Cross-Over Clinical Trials in comparison with Parallel groups clinical trials have some advantages such as control of confounding variables, small sample size, and short time to implement the research project. But this type of research has few essential limitations that discusses in this monogram.

  9. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...... the design, conduct and analytical approaches to RCTs evaluating the preventative effect of joint injury prevention strategies. Recommendations regarding the design, conduct, and reporting of RCTs evaluating injury prevention interventions were established based on the consensus of nine researchers...... internationally with expertise in epidemiology, injury prevention and/or osteoarthritis (OA). Input and resultant consensus was established through teleconference, face to face and email correspondence over a 1 year period. Recommendations for injury prevention RCTs include context specific considerations...

  10. Industrial demonstration trials

    International Nuclear Information System (INIS)

    Gelee, M.; Fabre, C.; Villepoix, R. de; Fra, J.; Le Foulgoc, L.; Morel, Y.; Querite, P.; Roques, R.

    1975-01-01

    Prototypes of the plant components, meeting the specifications set by the process and built by industrial firms in collaboration with the supervisor and the C.E.A., are subjected to trial runs on the UF 6 test bench of the Pierrelatte testing zone. These items of equipment (diffuser, compressor, exchanger) are placed in an industrial operation context very similar to that of an enrichment plant. Their performance is measured within a broad region around the working point and their reliability observed over periods up to several tens of thousands of hours. Between 1969 and 1973 six industrial demonstration test benches have been built, marking the stages in the technical preparation of the 1973 file on the basis of which the decision of building was taken by Eurodif [fr

  11. LTDNA Evidence on Trial

    Science.gov (United States)

    Roberts, Paul

    2016-01-01

    Adopting the interpretative/hermeneutical method typical of much legal scholarship, this article considers two sets of issues pertaining to LTDNA profiles as evidence in criminal proceedings. The section titled Expert Evidence as Forensic Epistemic Warrant addresses some rather large questions about the epistemic status and probative value of expert testimony in general. It sketches a theoretical model of expert evidence, highlighting five essential criteria: (1) expert competence; (2) disciplinary domain; (3) methodological validity; (4) materiality; and (5) legal admissibility. This generic model of expert authority, highlighting law's fundamentally normative character, applies to all modern forms of criminal adjudication, across Europe and farther afield. The section titled LTDNA Evidence in UK Criminal Trials then examines English and Northern Irish courts' attempts to get to grips with LTDNA evidence in recent cases. Better appreciating the ways in which UK courts have addressed the challenges of LTDNA evidence may offer some insights into parallel developments in other legal systems. Appellate court rulings follow a predictable judicial logic, which might usefully be studied and reflected upon by any forensic scientist or statistician seeking to operate effectively in criminal proceedings. Whilst each legal jurisdiction has its own unique blend of jurisprudence, institutions, cultures and historical traditions, there is considerable scope for comparative analysis and cross-jurisdictional borrowing and instruction. In the spirit of promoting more nuanced and sophisticated international interdisciplinary dialogue, this article examines UK judicial approaches to LTDNA evidence and begins to elucidate their underlying institutional logic. Legal argument and broader policy debates are not confined to considerations of scientific validity, contamination risks and evidential integrity, or associated judgments of legal admissibility or exclusion. They also crucially

  12. ANFO truck burn trials

    Energy Technology Data Exchange (ETDEWEB)

    Rosen von, B.; Contestabile, E. [Natural Resources Canada, CANMET Canadian Explosives Research Laboratory, Ottawa, ON (Canada)

    2003-10-01

    This report describes the investigation of a tractor-trailer explosion. A truck loaded with 18,000 kg of commercial explosives, of which 13,000 kg was ammonium nitrate with fuel oil (ANFO), caught fire when it struck a rockcut near Walden, Ontario on August 5, 1998. The fire resulted in the detonation of the load. The Canadian Explosives Research Laboratory (CERL) conducted a test program to examine the suitability of existing explosive transportation regulations. Unconfined burns of ANFO were performed. The accident was recreated in two burn trials in an attempt to identify the mechanism that led from fire to detonation. Two full-scale tests were conducted using complete tractor-trailers, each in a jack-knifed position with most of the explosives placed on the ground in front of the trailer. ANFO was used in the first test to determine its response to thermal stimulus and the likelihood of detonation or explosion. The second test involved ANFO, a slurry and an emulsion. Thermocouples and video cameras were used to observe the burning characteristics of the explosives, the truck and its components. The explosives burned steadily for 80 minutes in each test. Many truck components, such as tires, spring brake chambers and the fuel tank ruptured violently due to the heat. Although no detonation occurred in the test trials, it was concluded that under favourable conditions, many truck components, might produce fragments with enough energy to initiate heat-sensitized explosives. It was suggested that a fragment impact caused the detonation at Walden. 4 refs., 7 tabs., 8 figs.

  13. LTDNA Evidence on Trial.

    Science.gov (United States)

    Roberts, Paul

    2016-01-01

    Adopting the interpretative/hermeneutical method typical of much legal scholarship, this article considers two sets of issues pertaining to LTDNA profiles as evidence in criminal proceedings. The section titled Expert Evidence as Forensic Epistemic Warrant addresses some rather large questions about the epistemic status and probative value of expert testimony in general. It sketches a theoretical model of expert evidence, highlighting five essential criteria: (1) expert competence; (2) disciplinary domain; (3) methodological validity; (4) materiality; and (5) legal admissibility. This generic model of expert authority, highlighting law's fundamentally normative character, applies to all modern forms of criminal adjudication, across Europe and farther afield. The section titled LTDNA Evidence in UK Criminal Trials then examines English and Northern Irish courts' attempts to get to grips with LTDNA evidence in recent cases. Better appreciating the ways in which UK courts have addressed the challenges of LTDNA evidence may offer some insights into parallel developments in other legal systems. Appellate court rulings follow a predictable judicial logic, which might usefully be studied and reflected upon by any forensic scientist or statistician seeking to operate effectively in criminal proceedings. Whilst each legal jurisdiction has its own unique blend of jurisprudence, institutions, cultures and historical traditions, there is considerable scope for comparative analysis and cross-jurisdictional borrowing and instruction. In the spirit of promoting more nuanced and sophisticated international interdisciplinary dialogue, this article examines UK judicial approaches to LTDNA evidence and begins to elucidate their underlying institutional logic. Legal argument and broader policy debates are not confined to considerations of scientific validity, contamination risks and evidential integrity, or associated judgments of legal admissibility or exclusion. They also crucially

  14. Using simulation to aid trial design: Ring-vaccination trials.

    Directory of Open Access Journals (Sweden)

    Matt David Thomas Hitchings

    2017-03-01

    Full Text Available The 2014-6 West African Ebola epidemic highlights the need for rigorous, rapid clinical trial methods for vaccines. A challenge for trial design is making sample size calculations based on incidence within the trial, total vaccine effect, and intracluster correlation, when these parameters are uncertain in the presence of indirect effects of vaccination.We present a stochastic, compartmental model for a ring vaccination trial. After identification of an index case, a ring of contacts is recruited and either vaccinated immediately or after 21 days. The primary outcome of the trial is total vaccine effect, counting cases only from a pre-specified window in which the immediate arm is assumed to be fully protected and the delayed arm is not protected. Simulation results are used to calculate necessary sample size and estimated vaccine effect. Under baseline assumptions about vaccine properties, monthly incidence in unvaccinated rings and trial design, a standard sample-size calculation neglecting dynamic effects estimated that 7,100 participants would be needed to achieve 80% power to detect a difference in attack rate between arms, while incorporating dynamic considerations in the model increased the estimate to 8,900. This approach replaces assumptions about parameters at the ring level with assumptions about disease dynamics and vaccine characteristics at the individual level, so within this framework we were able to describe the sensitivity of the trial power and estimated effect to various parameters. We found that both of these quantities are sensitive to properties of the vaccine, to setting-specific parameters over which investigators have little control, and to parameters that are determined by the study design.Incorporating simulation into the trial design process can improve robustness of sample size calculations. For this specific trial design, vaccine effectiveness depends on properties of the ring vaccination design and on the

  15. Early clinical outcomes as a function of use of newer oral P2Y inhibitors versus clopidogrel in the EUROMAX trial

    DEFF Research Database (Denmark)

    Huber, Kurt; Ducrocq, Gregory; Hamm, Christian W

    2017-01-01

    prehospital bivalirudin with heparin with optional glycoprotein IIb/IIIa inhibitor treatment in patients with ST-segment elevation myocardial infarction triaged to pPCI. Choice of P2Y12 inhibitor was at the investigator's discretion. In a prespecified analysis, we compared event rates with clopidogrel....... Logistic regression was used to adjust for differences in baseline characteristics. Results: Prasugrel or ticagrelor was given as the loading P2Y12 inhibitor in 49% of 2198 patients and as a maintenance therapy in 59%. No differences were observed in rates of acute stent thrombosis for clopidogrel versus...

  16. Social media in clinical trials.

    Science.gov (United States)

    Thompson, Michael A

    2014-01-01

    Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape.

  17. Quality Assurance for Clinical Trials

    Science.gov (United States)

    Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

    2013-01-01

    Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

  18. Frailty Intervention Trial (FIT

    Directory of Open Access Journals (Sweden)

    Lockwood Keri

    2008-10-01

    Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a

  19. clinical trials of Sutherlandia frutescens

    African Journals Online (AJOL)

    economic and political imperatives surrounding randomised controlled trials and the ambiguous, or even ..... the medicinal properties of the plant, as reported both in the book, and also in the .... London, UK: Harvard University Press. Latour, B.

  20. Lung Cancer Precision Medicine Trials

    Science.gov (United States)

    Patients with lung cancer are benefiting from the boom in targeted and immune-based therapies. With a series of precision medicine trials, NCI is keeping pace with the rapidly changing treatment landscape for lung cancer.

  1. a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MS Yıldırım

    2016-02-01

    Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.

  2. Global warming on trial

    International Nuclear Information System (INIS)

    Broeker, W.S.

    1992-01-01

    Jim Hansen, a climatologist at NASA's Goddard Space Institute, is convinced that the earth's temperature is rising and places the blame on the buildup of greenhouse gases in the atmosphere. Unconvinced, John Sununu, former White House chief of staff, doubts that the warming will be great enough to produce serious threat and fears that measures to reduce the emissions would throw a wrench into the gears that drive the Unites States' troubled economy. During his three years at the White House, Sununu's view prevailed, and although his role in the debate has diminished, others continue to cast doubt on the reality of global warming. A new lobbying group called the Climate Council has been created to do just this. Burning fossil fuels is not the only problem; a fifth of emissions of carbon dioxide now come from clearing and burning forests. Scientists are also tracking a host of other greenhouse gases that emanate from a variety of human activities; the warming effect of methane, chlorofluorocarbons and nitrous oxide combined equals that of carbon dioxide. Although the current warming from these gases may be difficult to detect against the background noise of natural climate variation, most climatologists are certain that as the gases continue to accumulate, increases in the earth's temperature will become evident even to skeptics. If the reality of global warming were put on trial, each side would have trouble making its case. Jim Hansen's side could not prove beyond a reasonable doubt that carbon dioxide and other greenhouse gases have warmed the planet. But neither could John Sununu's side prove beyond a reasonable doubt that the warming expected from greenhouse gases has not occurred. To see why each side would have difficulty proving its case, this article reviews the arguments that might be presented in such a hearing

  3. Trial Watch: Anticancer radioimmunotherapy.

    Science.gov (United States)

    Vacchelli, Erika; Vitale, Ilio; Tartour, Eric; Eggermont, Alexander; Sautès-Fridman, Catherine; Galon, Jérôme; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2013-09-01

    Radiotherapy has extensively been employed as a curative or palliative intervention against cancer throughout the last century, with a varying degree of success. For a long time, the antineoplastic activity of X- and γ-rays was entirely ascribed to their capacity of damaging macromolecules, in particular DNA, and hence triggering the (apoptotic) demise of malignant cells. However, accumulating evidence indicates that (at least part of) the clinical potential of radiotherapy stems from cancer cell-extrinsic mechanisms, including the normalization of tumor vasculature as well as short- and long-range bystander effects. Local bystander effects involve either the direct transmission of lethal signals between cells connected by gap junctions or the production of diffusible cytotoxic mediators, including reactive oxygen species, nitric oxide and cytokines. Conversely, long-range bystander effects, also known as out-of-field or abscopal effects, presumably reflect the elicitation of tumor-specific adaptive immune responses. Ionizing rays have indeed been shown to promote the immunogenic demise of malignant cells, a process that relies on the spatiotemporally defined emanation of specific damage-associated molecular patterns (DAMPs). Thus, irradiation reportedly improves the clinical efficacy of other treatment modalities such as surgery (both in neo-adjuvant and adjuvant settings) or chemotherapy. Moreover, at least under some circumstances, radiotherapy may potentiate anticancer immune responses as elicited by various immunotherapeutic agents, including (but presumably not limited to) immunomodulatory monoclonal antibodies, cancer-specific vaccines, dendritic cell-based interventions and Toll-like receptor agonists. Here, we review the rationale of using radiotherapy, alone or combined with immunomodulatory agents, as a means to elicit or boost anticancer immune responses, and present recent clinical trials investigating the therapeutic potential of this approach in

  4. LTDNA Evidence on Trial

    Directory of Open Access Journals (Sweden)

    Paul Roberts

    2016-10-01

    factfinders in criminal trials.

  5. Successful recruitment to trials: findings from the SCIMITAR+ Trial.

    Science.gov (United States)

    Peckham, Emily; Arundel, Catherine; Bailey, Della; Callen, Tracy; Cusack, Christina; Crosland, Suzanne; Foster, Penny; Herlihy, Hannah; Hope, James; Ker, Suzy; McCloud, Tayla; Romain-Hooper, Crystal-Bella; Stribling, Alison; Phiri, Peter; Tait, Ellen; Gilbody, Simon

    2018-01-19

    Randomised controlled trials (RCT) can struggle to recruit to target on time. This is especially the case with hard to reach populations such as those with severe mental ill health. The SCIMITAR+ trial, a trial of a bespoke smoking cessation intervention for people with severe mental ill health achieved their recruitment ahead of time and target. This article reports strategies that helped us to achieve this with the aim of aiding others recruiting from similar populations. SCIMITAR+ is a multi-centre pragmatic two-arm parallel-group RCT, which aimed to recruit 400 participants with severe mental ill health who smoke and would like to cut down or quit. The study recruited primarily in secondary care through community mental health teams and psychiatrists with a smaller number of participants recruited through primary care. Recruitment opened in October 2015 and closed in December 2016, by which point 526 participants had been recruited. We gathered information from recruiting sites on strategies which led to the successful recruitment in SCIMITAR+ and in this article present our approach to trial management along with the strategies employed by the recruiting sites. Alongside having a dedicated trial manager and trial management team, we identified three main themes that led to successful recruitment. These were: clinicians with a positive attitude to research; researchers and clinicians working together; and the use of NHS targets. The overriding theme was the importance of relationships between both the researchers and the recruiting clinicians and the recruiting clinicians and the participants. This study makes a significant contribution to the limited evidence base of real-world cases of successful recruitment to RCTs and offers practical guidance to those planning and conducting trials. Building positive relationships between clinicians, researchers and participants is crucial to successful recruitment.

  6. Clinical trials. A pending subject.

    Science.gov (United States)

    Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

    2018-04-01

    Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  7. Pragmatic trial design elements showed a different impact on trial interpretation and feasibility than explanatory elements

    NARCIS (Netherlands)

    Nieuwenhuis, Joost B.; Irving, Elaine; Oude Rengerink, Katrien; Lloyd, Emily; Goetz, Iris; Grobbee, Diederick E.; Stolk, Pieter; Groenwold, Rolf H H; Zuidgeest, Mira G P

    2016-01-01

    OBJECTIVE: To illustrate how pragmatic trial design elements, or inserting explanatory trial elements in pragmatic trials affect validity, generalizability, precision and operational feasibility. STUDY DESIGN AND SETTING: From illustrative examples identified through the IMI Get Real Consortium, we

  8. Practical trials in medical education

    DEFF Research Database (Denmark)

    Tolsgaard, Martin G; Kulasegaram, Kulamakan M; Ringsted, Charlotte

    2017-01-01

    participants across several settings and (iii) multiple outcome measures with long-term follow-up to evaluate both benefits and risks. Questions posed by practical trials may be proactive in applying theory in the development of educational innovations or reactive to educational reforms and innovations. Non......CONTEXT: Concerns have been raised over the gap between education theory and practice and how research can contribute to inform decision makers on their choices and priorities. Little is known about how educational theories and research outcomes produced under optimal conditions in highly...... controlled settings generalise to the real-life education context. One way of bridging this gap is applying the concept of practical trials in medical education. In this paper we elaborate on characteristics of practical trials and based on examples from medical education we discuss the challenges...

  9. Adaptive designs in clinical trials

    Directory of Open Access Journals (Sweden)

    Suresh Bowalekar

    2011-01-01

    Full Text Available In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  10. Adaptive designs in clinical trials.

    Science.gov (United States)

    Bowalekar, Suresh

    2011-01-01

    In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA)/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  11. The DiaS trial

    DEFF Research Database (Denmark)

    Andreasson, Kate; Krogh, Jesper; Rosenbaum, Bent

    2014-01-01

    BACKGROUND: In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personali...... measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger, and duration of respective treatments. TRIAL REGISTRATION: Clinical Trial.gov: NCT01512602....

  12. Problematic trial detection in ClinicalTrials.gov

    NARCIS (Netherlands)

    Hartgerink, C.H.J.; George, Stephen

    2015-01-01

    Clinical trials are crucial in determining the effectiveness of treatments and directly affect clinical and policy decisions. These decisions are undermined if the data are problematic due to data fabrication or other errors. Researchers have worked on developing statistical methods to detect

  13. Trials by Juries: Suggested Practices for Database Trials

    Science.gov (United States)

    Ritterbush, Jon

    2012-01-01

    Librarians frequently utilize product trials to assess the content and usability of a database prior to committing funds to a new subscription or purchase. At the 2012 Electronic Resources and Libraries Conference in Austin, Texas, three librarians presented a panel discussion on their institutions' policies and practices regarding database…

  14. Evaluation Using Sequential Trials Methods.

    Science.gov (United States)

    Cohen, Mark E.; Ralls, Stephen A.

    1986-01-01

    Although dental school faculty as well as practitioners are interested in evaluating products and procedures used in clinical practice, research design and statistical analysis can sometimes pose problems. Sequential trials methods provide an analytical structure that is both easy to use and statistically valid. (Author/MLW)

  15. SARCOPENIA: DESIGNING PHASE IIB TRIALS

    Science.gov (United States)

    CHUMLEA, WM.C.; CESARI, M.; EVANS, W.J.; FERRUCCI, L.; FIELDING, R.A.; PAHOR, M.; STUDENSKI, S.; VELLAS, B.

    2012-01-01

    Sarcopenia is the age-related involuntary loss of skeletal muscle mass and functionality that can lead to the development of disability, frailty and increased health care costs. The development of interventions aimed at preventing and/or treating sarcopenia is complex, requiring the adoption of assumptions and standards that are not well established scientifically or clinically. A number of investigators and clinicians (both from academia and industry) met in Rome (Italy) in 2009 to develop a consensus definition of sarcopenia. Subsequently, in Albuquerque (New Mexico, USA) in 2010, the same group met again to consider the complex issues necessary for designing Phase II clinical trials for sarcopenia. Current clinical trial data indicate that fat-free mass (FFM) parameters are responsive to physical activity/nutritional treatment modalities over short time periods, but pharmacological trials of sarcopenia have yet to show significant efficacy. In order to conduct a clinical trial within a reasonable time frame, groups that model or display accelerated aging and loss of FFM are necessary. Few studies have used acceptable designs for testing treatment effects, sample sizes or primary outcomes that could provide interpretable findings or effects across studies. Dual energy x ray absorptiometry (DXA) is the measure of choice for assessing FFM, but sufficient time is needed for changes to be detected accurately and reliably. A tool set that would allow clinical, basic and epidemiological research on sarcopenia to advance rapidly toward diagnosis and treatment phases should be those reflecting function and strength. PMID:21623466

  16. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

    Møller, Christian H; Jensen, Birte Østergaard; Gluud, Christian

    2007-01-01

    Recent trials suggest that off-pump coronary artery bypass grafting (OPCAB) reduces the risk of mortality and morbidity compared with conventional coronary artery bypass grafting (CCAB) using cardiopulmonary bypass. Patients with a moderate- to high-risk of complications after CCAB may have...

  17. Medical Editors Trial Amnesty (META)

    African Journals Online (AJOL)

    may change jobs, with the result that important work remains unfinished; or investigators may discover a recently published trial on the same topic and conclude that their own results are now redundant. Editors must also take some responsibility. There is a limit to the number of reports we can publish and sometimes we are ...

  18. [Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial].

    Science.gov (United States)

    Rozenberg, P; Deruelle, P; Sénat, M-V; Desbrière, R; Winer, N; Simon, E; Ville, Y; Kayem, G; Boutron, I

    2018-04-01

    The data from literature show that trial of labor and elective repeat cesarean delivery after a prior cesarean delivery both present significant risks and benefits, and these risks and benefits differ for the woman and her fetus. The benefits to the woman can be at the expense of her fetus and vice-versa. This uncertainty is compounded by the scarcity of high-level evidence that preclude accurate quantification of the risks and benefits that could help provide a fair counseling about a trial of labor and elective repeat cesarean delivery. An interesting way of research is to evaluate the potential benefits of a decision rule associated to the ultrasound measurement of the lower uterine segment (LUS). Indeed, ultrasonography may be helpful in determining a specific risk for a given patient by measuring the thickness of the LUS, i,e, the thickness of the cesarean delivery scar area. Although only small and often methodologically biased data have been published, they look promising as their results are concordant: ultrasonographic measurements of the LUS thickness is highly correlated with the intraoperative findings at cesarean delivery. Furthermore, the thinner the LUS becomes on ultrasound, the higher the likelihood of a defect in the LUS. Finally, ultrasound assessment of LUS has an excellent negative predictive value for the risk of uterine defect. Therefore, this exam associated with a rule of decision could help to reduce the rate of elective repeat cesarean delivery and especially to reduce the fetal and maternal mortality and morbidity related to trial of labor after a prior cesarean delivery. This is a pragmatic open multicenter randomized trial with two parallel arms. Randomization will be centralized and computerized. Since blindness is impossible, an adjudication committee will evaluate the components of the primary composite outcome in order to avoid evaluation bias. An interim analysis will be planned mid-strength of the trial. Ultrasound will be

  19. [Principles of controlled clinical trials].

    Science.gov (United States)

    Martini, P

    1962-01-01

    The recovery of the patient should be facilitated as the result of therapeutic research. The basic rule for every therapeutic-clinical trial mist involve a comparison of therapeutic approaches. In acute conditions, such as acute infectious diseases, infarcts, etc., comparisons should be made between two or more groups: the collective therapeutic comparison = the between patients trial. The formation of groups, to be compared one with the other can be justified only if one is reasonably sure that a pathogenic condition indeed exists. In chronic diseases, which extend essentially unchanged over a lengthy period but are nevertheless reversible, therapeutic comparisons may be made between two or more time intervals within the course of the disease in the same individual. This type of therapeutic trial rests primarily upon a (refined!) type of specious reasoning and secondarily, upon modified statistics: the individual therapeutic comparison = the within patient trial. The collective therapeutic comparison, on the one hand, and the individual therapeutic comparison on the other, overlap somewhat in scope. The immediate therapeutic effect is not always an indication of its true value, which may become evident only upon long-term treatment. The short-term trials of therapeutic regimens in an individual must, therefore, be frequently supplemented by long-term trials which can only be carried out by comparing two groups. For many clinical investigations, therefore, the joint efforts of numerous hospitals are absolutely necessary. The second basic rule of therapeutic research is the elimination of secondary causes. The difficulties introduced by these secondary considerations are far greater in therapeutic trials carried out on ambulatory patients than has been hitherto realized. In order to remove subjective secondary causes, the author demanded, in 1931, the use of hidden or illusory media (placebos, dummies) that is, unconscious causative agents. The double blind

  20. HIV/AIDS Clinical Trials Fact Sheet

    Science.gov (United States)

    ... AIDS Drugs Clinical Trials Apps skip to content HIV Overview Home Understanding HIV/AIDS Fact Sheets HIV/ ... 4 p.m. ET) Send us an email HIV/AIDS Clinical Trials Last Reviewed: August 25, 2017 ...

  1. NCI National Clinical Trials Network Structure

    Science.gov (United States)

    Learn about how the National Clinical Trials Network (NCTN) is structured. The NCTN is a program of the National Cancer Institute that gives funds and other support to cancer research organizations to conduct cancer clinical trials.

  2. Clinical trials in neurology: design, conduct, analysis

    National Research Council Canada - National Science Library

    Ravina, Bernard

    2012-01-01

    .... Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases...

  3. PUPTH Prehospital Air Medical Plasma (PAMP) Trial

    Science.gov (United States)

    2014-07-01

    for ability to continue. If unable to improve, they may be replaced . Two formal interim analyses of efficacy will be performed when 33% and 67% of...will be entered and maintained on a password protected SSL website designed for this trial. The data entered for the PAMPer trial will be...testing procedure for clinical trials. Biometrics , 1979. 35(3): p. 549‐56. 96. Murray, D.M., ed. The Design and Analysis of Group Randomized Trials

  4. Trial-to-Trial Fluctuations in Attentional State and Their Relation to Intelligence

    Science.gov (United States)

    Unsworth, Nash; McMillan, Brittany D.

    2014-01-01

    Trial-to-trial fluctuations in attentional state while performing measures of intelligence were examined in the current study. Participants performed various measures of fluid and crystallized intelligence while also providing attentional state ratings prior to each trial. It was found that pre-trial attentional state ratings strongly predicted…

  5. Interpreting clinical trial results by deductive reasoning: In search of improved trial design.

    Science.gov (United States)

    Kurbel, Sven; Mihaljević, Slobodan

    2017-10-01

    Clinical trial results are often interpreted by inductive reasoning, in a trial design-limited manner, directed toward modifications of the current clinical practice. Deductive reasoning is an alternative in which results of relevant trials are combined in indisputable premises that lead to a conclusion easily testable in future trials. © 2017 WILEY Periodicals, Inc.

  6. Trial Courts in the Judicial Process.

    Science.gov (United States)

    McKnight, R. Neal

    1981-01-01

    Describes a college course which examines the organizational and behavioral characteristics of trial courts in the American judicial process. A major course objective is to help students understand the trial court process as a political process by showing how trial court organizations are involved in the allocation of social values. (RM)

  7. Terrorists on Trial: A Performative Perspective

    NARCIS (Netherlands)

    de Graaf, B.A.

    On 30 March 2011, ICCT – The Hague organised an Expert Meeting entitled ‘Terrorism Trials as Theatre: A Performative Perspective’. The Expert Meeting applied a performative perspective to three well known and recent trials in different parts of the world: the trials against the Dutch Hofstad Group,

  8. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly vari...

  9. Spine device clinical trials: design and sponsorship.

    Science.gov (United States)

    Cher, Daniel J; Capobianco, Robyn A

    2015-05-01

    Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (pdevices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. Pediatric Obstructive Uropathy: Clinical Trials

    International Nuclear Information System (INIS)

    Chan, C. M. C.; Scheinman, J. I.; Roth, K. S.

    2005-01-01

    As the powerful tools of molecular biology continue to delineate new concepts of pathogenesis of diseases, new molecular-level therapeutic modalities are certain to emerge. In order to design and execute clinical trials to evaluate outcomes of these new treatment modalities, we will soon need a new supply of investigators with training and experience in clinical research. The slowly-progressive nature of chronic pediatric kidney disease often results in diagnosis being made at a time remote from initial result, and the inherently slow rate of progression makes changes difficult to measure. Thus, development of molecular markers for both diagnosis and rate of progression will be critical to studies of new therapeutic modalities. We will review general aspects of clinical trials and will use current and past studies as examples to illustrate specific points, especially as these apply to chronic kidney disease associated with obstructive uropathy in children. (author)

  11. GPON FTTH trial: lessons learned

    Science.gov (United States)

    Weis, Erik; Hölzl, Rainer; Breuer, Dirk; Lange, Christoph

    2009-11-01

    This paper reports on a FTTH field trial with GPON (Gigabit-capable passive optical network) technology in the network of Deutsche Telekom in the region of the cities of Berlin and Potsdam. Focus of this trial was to gain practical experience regarding GPON technology, fibre installation in existing ducts with micro duct technology, fibre cabling in customer buildings and impact on operational processes. Furthermore it is reported on an initial Deutsche Telekom FTTB deployment based on GPON technology in the city of Dresden with the main targets to obtain practical deployment and operation experiences with fibre-based access networks and to provide broadband access to a part of the city formerly not servable by DSL (digital subscriber line) technology.

  12. Accrual to Cancer Clinical Trials

    LENUS (Irish Health Repository)

    Kelly, C

    2016-07-01

    Accrual to cancer clinical trials (CCT) is imperative to safeguard continued improvement in cancer outcomes. A retrospective chart review was performed of patients (n=140) starting a new anti-cancer agent in a north Dublin cancer centre. This review was performed over a four-month period, beginning in November 2015. Only 29% (n=41) had a CCT option. The overall accrual rate to CCT was 5% (n=7), which is comparable to internationally reported figures. The main reasons for failure to recruit to CCT included the lack of a CCT option for cancer type (n=30, 23%), stage (n=25, 19%), and line of treatment (n=23, 17%). Over the last decade, the rate of accrual to CCTs has in fact doubled and the number of trials open to recruitment has tripled. Ongoing governmental and philanthropic support is necessary to continue this trend to further expand CCT patient options with a target accrual rate of 10%.

  13. Methodology series module 4: Clinical trials

    Directory of Open Access Journals (Sweden)

    Maninder Singh Setia

    2016-01-01

    Full Text Available In a clinical trial, study participants are (usually divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care. We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1 parallel study design, (2 cross-over design, (3 factorial design, and (4 withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials. Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

  14. Methodology Series Module 4: Clinical Trials.

    Science.gov (United States)

    Setia, Maninder Singh

    2016-01-01

    In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

  15. Credentialing for participation in clinical trials

    International Nuclear Information System (INIS)

    Followill, David S.; Urie, Marcia; Galvin, James M.; Ulin, Kenneth; Xiao, Ying; FitzGerald, Thomas J.

    2012-01-01

    The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

  16. Credentialing for participation in clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Followill, David S. [Radiological Physics Center, Department of Radiation Physics, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Urie, Marcia [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Galvin, James M. [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); Ulin, Kenneth [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States); Xiao, Ying [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); FitzGerald, Thomas J., E-mail: dfollowi@mdanderson.org [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States)

    2012-12-26

    The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

  17. Clinical Trials in Noninfectious Uveitis

    Science.gov (United States)

    Kim, Jane S.; Knickelbein, Jared E.; Nussenblatt, Robert B.; Sen, H. Nida

    2015-01-01

    The treatment of noninfectious uveitis continues to remain a challenge for many ophthalmologists. Historically, clinical trials in uveitis have been sparse, and thus, most treatment decisions have largely been based on clinical experience and consensus guidelines. The current treatment paradigm favors initiation then tapering of corticosteroids with addition of steroid-sparing immunosuppressive agents for persistence or recurrence of disease. Unfortunately, in spite of a multitude of highly unfavorable systemic effects, corticosteroids are still regarded as the mainstay of treatment for many patients with chronic and refractory noninfectious uveitis. However, with the success of other conventional and biologic immunomodulatory agents in treating systemic inflammatory and autoimmune conditions, interest in targeted treatment strategies for uveitis has been renewed. Multiple clinical trials on steroid-sparing immunosuppressive agents, biologic agents, intraocular corticosteroid implants, and topical ophthalmic solutions have already been completed, and many more are ongoing. This review discusses the results and implications of these clinical trials investigating both alternative and novel treatment options for noninfectious uveitis. PMID:26035763

  18. Market Trials of Irradiated Spices

    International Nuclear Information System (INIS)

    Charoen, Saovapong; Eemsiri, Jaruratana; Sajjabut, Surasak

    2009-07-01

    Full text: The objectives of the experiment were to disseminate irradiated retail foods to the domestic publics and to test consumer acceptance on irradiated ground chilli and ground pepper. Market trials of irradiated ground chilli and ground pepper were carried out at 2 local markets and 4 in Bangkok and Nontaburi in 2005-2007. Before the start of the experiment, processing room, gamma irradiation room and labels of the products were approved by Food and Drug Administration, Thailand. 50 grams of irradiated products were packaged in plastic bags for the market trials. 688 and 738 bags of ground chilli and ground pepper were sold, respectively. Questionnaires distributed with the products were commented by 59 consumers and statistically analyzed by experimental data pass program. 88.1 and 91.4 percents of the consumers were satisfied with the quality and the price, respectively. 79.7% of the consumers chose to buy irradiated ground chilli and ground pepper because they believed that the quality of irradiated products were better than that of non-irradiated ones. 91.5% of the consumers would certainly buy irradiated chilli and pepper again. Through these market trials, it was found that all of the products were sold out and the majority of the consumers who returned the questionnaires was satisfied with the irradiated ground chilli and ground pepper and also had good attitude toward irradiated foods

  19. Clinical trials and gender medicine.

    Science.gov (United States)

    Cassese, Mariarita; Zuber, Veronica

    2011-01-01

    Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22%) which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa) which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  20. Clinical trials and gender medicine

    Directory of Open Access Journals (Sweden)

    Mariarita Cassese

    2011-01-01

    Full Text Available Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22% which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  1. Informed consent in surgical trials.

    Science.gov (United States)

    Etchells, E

    1999-12-01

    All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. To protect vulnerable persons, an incapable person should not be enrolled in most clinical trials. The only exception is if the study can only be conducted on incapable persons. If the willing research participant is incapable, consent must be obtained from others through a process called substitute (or proxy) consent. Disclosure refers to the provision of relevant information to the patient and its comprehension by the patient. Most surgical trials carry more than minimal risks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.

  2. Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

    Science.gov (United States)

    Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

    2012-07-01

    Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

  3. Physical activity and trial-by-trial adjustments of response conflict.

    Science.gov (United States)

    Kamijo, Keita; Takeda, Yuji

    2013-08-01

    The relationship of physical activity to trial-by-trial adjustments of response conflict was assessed using behavioral task performance, the N2 event-related brain potential component, and phase-locking values (PLVs) in a lower gamma band during a perceptual conflict task. Nineteen physically active and 19 inactive young adults (mean age = 21.3 years) performed a Navon task, using a global letter made up of local letters of either the same kind (congruent trials) or a different kind (incongruent trials). Findings revealed that active individuals exhibited smaller N2 amplitudes and greater PLVs on incongruent trials that were preceded by incongruent trials compared with those preceded by congruent trials. Such phenomena were not observed for inactive individuals. These results suggest that greater physical activity is associated with larger trial-by-trial adjustments of response conflict, which we attribute to upregulation of top-down cognitive control and reductions in response conflict.

  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. Critical concepts in adaptive clinical trials

    Directory of Open Access Journals (Sweden)

    Park JJH

    2018-03-01

    Full Text Available Jay JH Park,1 Kristian Thorlund,2,3 Edward J Mills2,3 1Department of Medicine, University of British Columbia, Vancouver, BC, Canada; 2Department of Health Research Methods, Evidence, and Impact (HEI, McMaster University, Hamilton, ON, Canada; 3The Bill and Melinda Gates Foundation, Seattle, WA, USA Abstract: Adaptive clinical trials are an innovative trial design aimed at reducing resources, decreasing time to completion and number of patients exposed to inferior interventions, and improving the likelihood of detecting treatment effects. The last decade has seen an increasing use of adaptive designs, particularly in drug development. They frequently differ importantly from conventional clinical trials as they allow modifications to key trial design components during the trial, as data is being collected, using preplanned decision rules. Adaptive designs have increased likelihood of complexity and also potential bias, so it is important to understand the common types of adaptive designs. Many clinicians and investigators may be unfamiliar with the design considerations for adaptive designs. Given their complexities, adaptive trials require an understanding of design features and sources of bias. Herein, we introduce some common adaptive design elements and biases and specifically address response adaptive randomization, sample size reassessment, Bayesian methods for adaptive trials, seamless trials, and adaptive enrichment using real examples. Keywords: adaptive designs, response adaptive randomization, sample size reassessment, Bayesian adaptive trials, seamless trials, adaptive enrichment

  6. Where are clinical trials going? Society and clinical trials.

    Science.gov (United States)

    Sleight, P

    2004-02-01

    Clinical trials now increasingly impinge on society at large. First there is growing emphasis from health organizations on the need for unbiased evidence about the effectiveness of promoted remedies. Second, as most novel treatments accrue increased costs to society, these need to be evaluated in terms of value for money. Third, there has been confusion and concern about the resolution of conflicting evidence, especially the role of advertising and commercial pressures from a powerful pharmaceutical industry motivated by profit. Fourth, there is concern about research fraud and the ethics of clinical trials. Fifth, there is increasing suspicion of political advice, which sometimes has sought to reassure an anxious public on the basis of complex and possibly inadequate scientific information. Some of these issues are addressed by truly independent and properly constituted data and safety monitoring committees, which are of particular importance when academic investigators or universities have a large financial conflict of interest. This is now more problematic with the current encouragement of investigator-led spin-off companies. These issues are best resolved by independent financial support (from government or other institutions) rather than relying on the commercial sponsor.

  7. Predictive value of diminutive colonic adenoma trial: the PREDICT trial.

    Science.gov (United States)

    Schoenfeld, Philip; Shad, Javaid; Ormseth, Eric; Coyle, Walter; Cash, Brooks; Butler, James; Schindler, William; Kikendall, Walter J; Furlong, Christopher; Sobin, Leslie H; Hobbs, Christine M; Cruess, David; Rex, Douglas

    2003-05-01

    Diminutive adenomas (1-9 mm in diameter) are frequently found during colon cancer screening with flexible sigmoidoscopy (FS). This trial assessed the predictive value of these diminutive adenomas for advanced adenomas in the proximal colon. In a multicenter, prospective cohort trial, we matched 200 patients with normal FS and 200 patients with diminutive adenomas on FS for age and gender. All patients underwent colonoscopy. The presence of advanced adenomas (adenoma >or= 10 mm in diameter, villous adenoma, adenoma with high grade dysplasia, and colon cancer) and adenomas (any size) was recorded. Before colonoscopy, patients completed questionnaires about risk factors for adenomas. The prevalence of advanced adenomas in the proximal colon was similar in patients with diminutive adenomas and patients with normal FS (6% vs. 5.5%, respectively) (relative risk, 1.1; 95% confidence interval [CI], 0.5-2.6). Diminutive adenomas on FS did not accurately predict advanced adenomas in the proximal colon: sensitivity, 52% (95% CI, 32%-72%); specificity, 50% (95% CI, 49%-51%); positive predictive value, 6% (95% CI, 4%-8%); and negative predictive value, 95% (95% CI, 92%-97%). Male gender (odds ratio, 1.63; 95% CI, 1.01-2.61) was associated with an increased risk of proximal colon adenomas. Diminutive adenomas on sigmoidoscopy may not accurately predict advanced adenomas in the proximal colon.

  8. Gatekeepers for pragmatic clinical trials.

    Science.gov (United States)

    Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

    2015-10-01

    To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

  9. Center-Within-Trial Versus Trial-Level Evaluation of Surrogate Endpoints

    Science.gov (United States)

    Renfro, Lindsay A.; Shi, Qian; Xue, Yuan; Li, Junlong; Shang, Hongwei; Sargent, Daniel J.

    2014-01-01

    Evaluation of candidate surrogate endpoints using individual patient data from multiple clinical trials is considered the gold standard approach to validate surrogates at both patient and trial levels. However, this approach assumes the availability of patient-level data from a relatively large collection of similar trials, which may not be possible to achieve for a given disease application. One common solution to the problem of too few similar trials involves performing trial-level surrogacy analyses on trial sub-units (e.g., centers within trials), thereby artificially increasing the trial-level sample size for feasibility of the multi-trial analysis. To date, the practical impact of treating trial sub-units (centers) identically to trials in multi-trial surrogacy analyses remains unexplored, and conditions under which this ad hoc solution may in fact be reasonable have not been identified. We perform a simulation study to identify such conditions, and demonstrate practical implications using a multi-trial dataset of patients with early stage colon cancer. PMID:25061255

  10. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

    Science.gov (United States)

    Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

    2015-05-01

    A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  11. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

    Directory of Open Access Journals (Sweden)

    Joseph S Ross

    2009-09-01

    Full Text Available ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006.Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data

  12. Inherited Retinal Degenerative Clinical Trial Network. Addendum

    Science.gov (United States)

    2013-10-01

    inherited orphan retinal degenerative diseases and dry age-related macular degeneration (AMD) through the conduct of clinical trials and other...design and conduct of effective and efficient clinical trials for inherited orphan retinal degenerative diseases and dry AMD; • Limited number and...linica l trial in the NEER network for autosomal dominant retinitis pigmentosa, and the ProgSTAR studies for Stargardt disease ) . As new interventions b

  13. Strategies to improve retention in randomised trials

    Science.gov (United States)

    Brueton, Valerie C; Tierney, Jayne; Stenning, Sally; Harding, Seeromanie; Meredith, Sarah; Nazareth, Irwin; Rait, Greta

    2013-01-01

    Background Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. Objectives To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, EMBASE, PsycINFO, DARE, CINAHL, Campbell Collaboration's Social, Psychological, Educational and Criminological Trials Register, and ERIC. We handsearched conference proceedings and publication reference lists for eligible retention trials. We also surveyed all UK Clinical Trials Units to identify further studies. Selection criteria We included eligible retention trials of randomised or quasi-randomised evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance. Data collection and analysis We contacted authors to supplement or confirm data that we had extracted. For retention trials, we recorded data on the method of randomisation, type of strategy evaluated, comparator, primary outcome, planned sample size, numbers randomised and numbers retained. We used risk ratios (RR) to evaluate the effectiveness of the addition of strategies to improve retention. We assessed heterogeneity between trials using the Chi2 and I2 statistics. For main trials that hosted retention trials, we extracted data on disease area, intervention, population, healthcare setting, sequence generation and allocation concealment. Main results We identified 38 eligible retention trials. Included trials evaluated six broad types of strategies to improve retention. These

  14. Single-Trial Inference on Visual Attention

    DEFF Research Database (Denmark)

    Dyrholm, Mads; Kyllingsbæk, Søren; Vangkilde, Signe Allerup

    2011-01-01

    In this paper we take a step towards single-trial behavioral modeling within a Theory of Visual Attention (TVA). In selective attention tasks, such as the Partial Report paradigm, the subject is asked to ignore distractors and only report stimuli that belong to the target class. Nothing about...... Report trial. This result retrodicts a latent attentional state of the subject using the observed response from that particular trial and thus differs from other predictions made with TVA which are based on expected values of observed variables. We show an example of the result in single-trial analysis...

  15. Power analysis of trials with multilevel data

    CERN Document Server

    Moerbeek, Mirjam

    2015-01-01

    Power Analysis of Trials with Multilevel Data covers using power and sample size calculations to design trials that involve nested data structures. The book gives a thorough overview of power analysis that details terminology and notation, outlines key concepts of statistical power and power analysis, and explains why they are necessary in trial design. It guides you in performing power calculations with hierarchical data, which enables more effective trial design.The authors are leading experts in the field who recognize that power analysis has attracted attention from applied statisticians i

  16. Inactive trials of transport systems

    International Nuclear Information System (INIS)

    Haberlin, M.M.; Hardy, A.R.

    1985-06-01

    The design and manufacture of a mock-up of a crate handling and size reduction (CHSR) facility, an experimental programme on the evaluation of a commercial air-transporter, and the selection, manufacture and commissioning trials of an integrated conveyor system for transporting crated waste into and within the mock-up facility, are considered. The mock-up facility was used for the test programme on the air-transporter and conveyor system. The air-transporter was considered suitable for transporting waste on the metal floor in the main dismantling area of the CHSR facility because it can tolerate asymmetric loading, the exhaust air flow liberated from the air-pads is low and it has excellent manoeuvrability. Commissioning trials were carried out on a commercial conveyor system consisting of unpowered rollers in the reception area, a powered slatted conveyor in the air-lock and an unpowered roller table placed on the air-transporter in the working area. It was demonstrated that a large asymmetrically loaded wooden crate can be transported into and within the facility by this method. Further design and experimental work necessary before the system can be used for remote operation is discussed. (author)

  17. The L'Aquila trial

    Science.gov (United States)

    Amato, Alessandro; Cocco, Massimo; Cultrera, Giovanna; Galadini, Fabrizio; Margheriti, Lucia; Nostro, Concetta; Pantosti, Daniela

    2013-04-01

    The first step of the trial in L'Aquila (Italy) ended with a conviction of a group of seven experts to 6 years of jail and several million euros refund for the families of the people who died during the Mw 6.3 earthquake on April 6, 2009. This verdict has a tremendous impact on the scientific community as well as on the way in which scientists deliver their expert opinions to decision makers and society. In this presentation, we describe the role of scientists in charge of releasing authoritative information concerning earthquakes and seismic hazard and the conditions that led to the verdict, in order to discuss whether this trial represented a prosecution to science, and if errors were made in communicating the risk. Documents, articles and comments about the trial are collected in the web site http://processoaquila.wordpress.com/. We will first summarize what was the knowledge about the seismic hazard of the region and the vulnerability of L'Aquila before the meeting of the National Commission for Forecasting and Predicting Great Risks (CGR) held 6 days before the main shock. The basic point of the accusation is that the CGR suggested that no strong earthquake would have occurred (which of course was never mentioned by any seismologist participating to the meeting). This message would have convinced the victims to stay at home, instead of moving out after the M3.9 and M3.5 earthquakes few hours before the mainshock. We will describe how the available scientific information was passed to the national and local authorities, and in general how the Italian scientific Institution in charge of seismic monitoring and research (INGV), the Civil Protection Department (DPC) and the CGR should interact according to the law. As far as the communication and outreach to the public, the scientific Institutions as INGV have the duty to communicate scientific information. Instead, the risk management and the definition of actions for risk reduction is in charge of Civil

  18. Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

    Science.gov (United States)

    Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

    2017-12-01

    Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (ppublication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

  19. Trial Sequential Methods for Meta-Analysis

    Science.gov (United States)

    Kulinskaya, Elena; Wood, John

    2014-01-01

    Statistical methods for sequential meta-analysis have applications also for the design of new trials. Existing methods are based on group sequential methods developed for single trials and start with the calculation of a required information size. This works satisfactorily within the framework of fixed effects meta-analysis, but conceptual…

  20. Challenges in conducting clinical trials in nephrology

    DEFF Research Database (Denmark)

    Baigent, Colin; Herrington, William G; Coresh, Josef

    2017-01-01

    Despite the high costs of treatment of people with kidney disease and associated comorbid conditions, the amount of reliable information available to guide the care of such patients is very limited. Some treatments have been assessed in randomized trials, but most such trials have been too small ...

  1. Blinded trials taken to the test

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Forfang, E; Haahr, M T

    2007-01-01

    Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful....

  2. RTOG: Updated results of randomized trials

    International Nuclear Information System (INIS)

    Curran, Walter J.

    1997-01-01

    Objective: To review the background, rationale and available results for recently completed randomized comparative clinical trials of the Radiation Therapy Oncology Group (RTOG), including inter group trials in which the RTOG has been the managing group or a major participant. When available, laboratory studies will be correlated with clinical results

  3. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded

  4. Controversy, Trials, and Crime--Oh My!

    Science.gov (United States)

    Rott, Kim

    2006-01-01

    Teenagers' innate interest with the justice system is one of the reasons that so many high school literary classics teem with criminals, controversial issues, and trials. Novels such as "To Kill a Mockingbird," "A Separate Peace," "The Crucible," and "Twelve Angry Men" feature high-impact trials. In the author's desire to tap into this interest,…

  5. Alien wavelength modeling tool and field trial

    DEFF Research Database (Denmark)

    Sambo, N.; Sgambelluri, A.; Secondini, M.

    2015-01-01

    A modeling tool is presented for pre-FEC BER estimation of PM-QPSK alien wavelength signals. A field trial is demonstrated and used as validation of the tool's correctness. A very close correspondence between the performance of the field trial and the one predicted by the modeling tool has been...

  6. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    , in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  7. The Eichmann Trial on East German Television

    NARCIS (Netherlands)

    Keilbach, Judith

    2014-01-01

    abstractThe trial against Adolf Eichmann was one of the first transnational media events on television. Its world-wide coverage required transnational cooperation. Using East German television reports about the trial this article argues that although the event transcended national borders it

  8. The Eichmann Trial on East German Television

    Directory of Open Access Journals (Sweden)

    Judith Keilbach

    2014-06-01

    Full Text Available The trial against Adolf Eichmann was one of the first transnational media events on television. Its world-wide coverage required transnational cooperation. Using East German television reports about the trial this article argues that although the event transcended national borders it maintained at the same time ideological boundaries.

  9. Internet trials: participant experiences and perspectives.

    Science.gov (United States)

    Mathieu, Erin; Barratt, Alexandra; Carter, Stacy M; Jamtvedt, Gro

    2012-10-23

    Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants' attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate). Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants' comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience - a perceived benefit - and a lack connectedness and understanding - a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet; security, privacy and confidentiality issues; perceived benefits and

  10. Terrorists on Trial: A Performative Perspective

    Directory of Open Access Journals (Sweden)

    Beatrice de Graaf

    2011-03-01

    Full Text Available On 30 March 2011, ICCT organised an Expert Meeting entitled “Terrorism Trials as Theatre: A Performative Perspective”. The Expert Meeting applied a performative perspective to three well known and recent trials in different parts of the world: the trials against the Dutch Hofstad Group, the Mumbai 2008 Terrorist Attack Trial and the Guantanamo Military Tribunals. As such, the Expert Meeting did not concentrate solely on the immediate judicial performance of the magistrates and/or the defence; instead, the trials were put in their wider sociological context, adopting notions of social drama and communication sciences. This Expert Meeting Paper is a further adaptation of the Discussion Paper that was used as basis for debate during the Meeting.

  11. Strategies to improve recruitment to randomised trials.

    Science.gov (United States)

    Treweek, Shaun; Pitkethly, Marie; Cook, Jonathan; Fraser, Cynthia; Mitchell, Elizabeth; Sullivan, Frank; Jackson, Catherine; Taskila, Tyna K; Gardner, Heidi

    2018-02-22

    Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research. To quantify the effects of strategies for improving recruitment of participants to randomised trials. A secondary objective is to assess the evidence for the effect of the research setting (e.g. primary care versus secondary care) on recruitment. We searched the Cochrane Methodology Review Group Specialised Register (CMR) in the Cochrane Library (July 2012, searched 11 February 2015); MEDLINE and MEDLINE In Process (OVID) (1946 to 10 February 2015); Embase (OVID) (1996 to 2015 Week 06); Science Citation Index & Social Science Citation Index (ISI) (2009 to 11 February 2015) and ERIC (EBSCO) (2009 to 11 February 2015). Randomised and quasi-randomised trials of methods to increase recruitment to randomised trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. We excluded studies aiming to increase response rates to questionnaires or trial retention and those evaluating incentives and disincentives for clinicians to recruit participants. We extracted data on: the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used a risk difference to estimate the absolute improvement and the 95% confidence interval (CI) to describe the effect in individual trials. We assessed heterogeneity between trial results. We used GRADE to judge the certainty we had in the evidence coming from each comparison. We identified 68 eligible trials (24 new to this update) with more than 74,000 participants. There were 63 studies involving interventions aimed directly at trial participants, while five evaluated interventions aimed at people recruiting participants. All studies were in

  12. 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.

  13. 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.

  14. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  15. Reinventing clinical trials: a review of innovative biomarker trial designs in cancer therapies.

    Science.gov (United States)

    Lin, Ja-An; He, Pei

    2015-06-01

    Recently, new clinical trial designs involving biomarkers have been studied and proposed in cancer clinical research, in the hope of incorporating the rapid growing basic research into clinical practices. Journal articles related to various biomarkers and their role in cancer clinical trial, articles and books about statistical issues in trial design, and regulatory website, documents, and guidance for submission of targeted cancer therapies. The drug development process involves four phases. The confirmatory Phase III is essential in regulatory approval of a special treatment. Regulatory agency has restrictions on confirmatory trials 'using adaptive designs'. No rule of thumb to pick the most appropriate design for biomarker-related trials. Statistical issues to solve in new designs. Regulatory acceptance of the 'newly proposed trial designs'. Biomarker-related trial designs that can resolve the statistical issues and satisfy the regulatory requirement. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  16. Recruitment to publicly funded trials--are surgical trials really different?

    Science.gov (United States)

    Cook, Jonathan A; Ramsay, Craig R; Norrie, John

    2008-09-01

    Good recruitment is integral to the conduct of a high-quality randomised controlled trial. It has been suggested that recruitment is particularly difficult for evaluations of surgical interventions, a field in which there is a dearth of evidence from randomised comparisons. While there is anecdotal speculation to support the inference that recruitment to surgical trials is more challenging than for medical trials we are unaware of any formal assessment of this. In this paper, we compare recruitment to surgical and medical trials using a cohort of publicly funded trials. Overall recruitment to trials was assessed using of a cohort of publicly funded trials (n=114). Comparisons were made by using the Recruitment Index, a simple measure of recruitment activity for multicentre randomised controlled trials. Recruitment at the centre level was also investigated through three example surgical trials. The Recruitment Index was found to be higher, though not statistically significantly, in the surgical group (n=18, median=38.0 IQR (10.7, 77.4)) versus (n=81, median=34.8 IQR (11.7, 98.0)) days per recruit for the medical group (median difference 1.7 (-19.2, 25.1); p=0.828). For the trials where the comparison was between a surgical and a medical intervention, the Recruitment Index was substantially higher (n=6, 68.3 (23.5, 294.8)) versus (n=93, 34.6 (11.7, 90.0); median difference 25.9 (-35.5, 221.8); p=0.291) for the other trials. There was no clear evidence that surgical trials differ from medical trials in terms of recruitment activity. There was, however, support for the inference that medical versus surgical trials are more difficult to recruit to. Formal exploration of the recruitment data through a modelling approach may go some way to tease out where important differences exist.

  17. Trial of Repeated Analgesia with Kangaroo Mother Care (TRAKC Trial)

    Science.gov (United States)

    2013-01-01

    preferred standard of care. However, current pain management guidelines are based on minimal data on repeated use of either intervention. Therefore, regardless of the outcomes of this study, results will have important implications for guidelines and practices related to management of procedural pain in preterm infants. Trial registration ClinicalTrials.gov Identifier: NCT01561547. PMID:24284002

  18. Disclosure of investigators' recruitment performance in multicenter clinical trials

    DEFF Research Database (Denmark)

    Dal-Ré, Rafael; Moher, David; Gluud, Christian

    2011-01-01

    Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.......Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends....

  19. Re-Engineering Alzheimer Clinical Trials: Global Alzheimer's Platform Network.

    Science.gov (United States)

    Cummings, J; Aisen, P; Barton, R; Bork, J; Doody, R; Dwyer, J; Egan, J C; Feldman, H; Lappin, D; Truyen, L; Salloway, S; Sperling, R; Vradenburg, G

    2016-06-01

    Alzheimer's disease (AD) drug development is costly, time-consuming, and inefficient. Trial site functions, trial design, and patient recruitment for trials all require improvement. The Global Alzheimer Platform (GAP) was initiated in response to these challenges. Four GAP work streams evolved in the US to address different trial challenges: 1) registry-to-cohort web-based recruitment; 2) clinical trial site activation and site network construction (GAP-NET); 3) adaptive proof-of-concept clinical trial design; and 4) finance and fund raising. GAP-NET proposes to establish a standardized network of continuously funded trial sites that are highly qualified to perform trials (with established clinical, biomarker, imaging capability; certified raters; sophisticated management system. GAP-NET will conduct trials for academic and biopharma industry partners using standardized instrument versions and administration. Collaboration with the Innovative Medicines Initiative (IMI) European Prevention of Alzheimer's Disease (EPAD) program, the Canadian Consortium on Neurodegeneration in Aging (CCNA) and other similar international initiatives will allow conduct of global trials. GAP-NET aims to increase trial efficiency and quality, decrease trial redundancy, accelerate cohort development and trial recruitment, and decrease trial costs. The value proposition for sites includes stable funding and uniform training and trial execution; the value to trial sponsors is decreased trial costs, reduced time to execute trials, and enhanced data quality. The value for patients and society is the more rapid availability of new treatments for AD.

  20. From randomised trials to rational practice.

    Science.gov (United States)

    van Gijn, J

    2005-01-01

    From the age of Enlightenment onwards, philosophical thinking has become increasingly influenced by empiricism: observations lead to theories, but experiments are needed to put the reasoning to the test. However, it was not until the middle of the 20th century that well-designed experiments were at last introduced in medical treatment, in the form of randomised controlled clinical trials. This design is now standard in medicine, but in everyday practice a multitude of management decisions must still be taken without good evidence. There are several reasons for this: there may not be a trial at all or only a single trial; trial results may be equivocal; patients may be different from those enrolled in trials; new procedures require practice, or a trial may not be feasible. 'Logical reasoning', with all its fallacies, is still required - not only to fill the gaps in empirical knowledge but also to interpret existing evidence and to plan new trials. In fact, the generation of new knowledge is a continuous, cyclical process in which newly gained insights in pathophysiology give rise to new therapeutic experiments, the results of which generate fresh hypotheses, and so on. Compassion, curiosity and doubt are the essential forces that keep the cycle moving. Conversely, the progress is slowed down by present-day legalism, which distorts investigator accountability and patient autonomy. Copyright (c) 2005 S. Karger AG, Basel.

  1. Clinical trial registration in oral health journals.

    Science.gov (United States)

    Smaïl-Faugeron, V; Fron-Chabouis, H; Durieux, P

    2015-03-01

    Prospective registration of randomized controlled trials (RCTs) represents the best solution to reporting bias. The extent to which oral health journals have endorsed and complied with RCT registration is unknown. We identified journals publishing RCTs in dentistry, oral surgery, and medicine in the Journal Citation Reports. We classified journals into 3 groups: journals requiring or recommending trial registration, journals referring indirectly to registration, and journals providing no reference to registration. For the 5 journals with the highest 2012 impact factors in each group, we assessed whether RCTs with results published in 2013 had been registered. Of 78 journals examined, 32 (41%) required or recommended trial registration, 19 (24%) referred indirectly to registration, and 27 (35%) provided no reference to registration. We identified 317 RCTs with results published in the 15 selected journals in 2013. Overall, 73 (23%) were registered in a trial registry. Among those, 91% were registered retrospectively and 32% did not report trial registration in the published article. The proportion of trials registered was not significantly associated with editorial policies: 29% with results in journals that required or recommended registration, 15% in those that referred indirectly to registration, and 21% in those providing no reference to registration (P = 0.05). Less than one-quarter of RCTs with results published in a sample of oral health journals were registered with a public registry. Improvements are needed with respect to how journals inform and require their authors to register their trials. © International & American Associations for Dental Research.

  2. Geographic differences in heart failure trials.

    Science.gov (United States)

    Ferreira, João Pedro; Girerd, Nicolas; Rossignol, Patrick; Zannad, Faiez

    2015-09-01

    Randomized controlled trials (RCTs) are essential to develop advances in heart failure (HF). The need for increasing numbers of patients (without substantial cost increase) and generalization of results led to the disappearance of international boundaries in large RCTs. The significant geographic differences in patients' characteristics, outcomes, and, most importantly, treatment effect observed in HF trials have recently been highlighted. Whether the observed regional discrepancies in HF trials are due to trial-specific issues, patient heterogeneity, structural differences in countries, or a complex interaction between factors are the questions we propose to debate in this review. To do so, we will analyse and review data from HF trials conducted in different world regions, from heart failure with preserved ejection fraction (HF-PEF), heart failure with reduced ejection fraction (HF-REF), and acute heart failure (AHF). Finally, we will suggest objective and actionable measures in order to mitigate regional discrepancies in future trials, particularly in HF-PEF where prognostic modifying treatments are urgently needed and in which trials are more prone to selection bias, due to a larger patient heterogeneity. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.

  3. The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

    Directory of Open Access Journals (Sweden)

    Scardino Peter T

    2009-03-01

    Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

  4. Are multiple-trial experiments appropriate for eyewitness identification studies? Accuracy, choosing, and confidence across trials.

    Science.gov (United States)

    Mansour, J K; Beaudry, J L; Lindsay, R C L

    2017-12-01

    Eyewitness identification experiments typically involve a single trial: A participant views an event and subsequently makes a lineup decision. As compared to this single-trial paradigm, multiple-trial designs are more efficient, but significantly reduce ecological validity and may affect the strategies that participants use to make lineup decisions. We examined the effects of a number of forensically relevant variables (i.e., memory strength, type of disguise, degree of disguise, and lineup type) on eyewitness accuracy, choosing, and confidence across 12 target-present and 12 target-absent lineup trials (N = 349; 8,376 lineup decisions). The rates of correct rejections and choosing (across both target-present and target-absent lineups) did not vary across the 24 trials, as reflected by main effects or interactions with trial number. Trial number had a significant but trivial quadratic effect on correct identifications (OR = 0.99) and interacted significantly, but again trivially, with disguise type (OR = 1.00). Trial number did not significantly influence participants' confidence in correct identifications, confidence in correct rejections, or confidence in target-absent selections. Thus, multiple-trial designs appear to have minimal effects on eyewitness accuracy, choosing, and confidence. Researchers should thus consider using multiple-trial designs for conducting eyewitness identification experiments.

  5. Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

    Science.gov (United States)

    Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

    2018-03-01

    Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

  6. The Mycotic Ulcer Treatment Trial

    Science.gov (United States)

    Prajna, N. Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Prajna, Lalitha; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E.; Ray, Kathryn J.; Zegans, Michael E.; McLeod, Stephen D.; Porco, Travis C.; Acharya, Nisha R.; Lietman, Thomas M.

    2013-01-01

    Objective To compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis. Methods This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. Main Outcome Measures The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. Results A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycin-treated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=−0.18 logMAR; 95% CI, −0.30 to −0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=−0.41 logMAR; 95% CI, −0.61 to −0.20; P<.001; odds ratio for perforation=0.06; 95% CI, 0.01 to 0.28; P<.001), while non-Fusarium cases fared similarly (regression coefficient=−0.02 logMAR; 95% CI, −0.17 to 0.13; P=.81; odds ratio for perforation=1.08; 95% CI, 0.48 to 2.43; P=.86). Conclusions Natamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. Application to Clinical Practice Voriconazole should not be used as monotherapy in filamentous keratitis. Trial Registration

  7. Juvenile offenders: competence to stand trial.

    Science.gov (United States)

    Soulier, Matthew

    2012-12-01

    This article details the legal background and assists the reader in the preparation and practical conduct of evaluations regarding juvenile adjudicative competency. The material is presented to be useful as a guide to direct questions of competency and covers aspects of evaluation that include: legal standard for competency to stand trial, developmental immaturity, current practice in juvenile competency to stand trial, forensic evaluation of juvenile competency to stand trial, organizing the evaluation, collateral sources of information, psychiatric evaluation of juvenile adjudicative competency, assessment of mental disorder and intellectual disability, assessment of developmental status, assessment of functional abilities for adjudicative competence, and reaching the forensic opinion. Copyright © 2012 Elsevier Inc. All rights reserved.

  8. Provenance trials of larch in Siberia

    Energy Technology Data Exchange (ETDEWEB)

    Milyutin, L.I. [V.N. Sukachev Inst. of Forest SB RAS, Krasnoyarsk (Russian Federation)

    1995-12-31

    Some results of provenance trials of larch in Siberia are given. These provenance trials were established in the last thirty years by efforts of V.N. Sukaczev Inst. of Forest. Provenances and species of larch were tested in some field trials distributed over Siberia between Lat. N 52 deg and 66 deg, Long. E 88 deg and 113 deg: near Krasnoyarsk, in Republic Khakasia (an altitudes of 800 and 1200 metres), in the Lower Yenisei near Turukhansk, in the west and south regions of Krasnoyarsk territory, in the Upper Lena, near Chita. 2 refs

  9. Clinical trials: bringing research to the bedside.

    Science.gov (United States)

    Arvay, C A

    1991-02-01

    Over the years, clinical trials with their structured treatment plans and multicenter involvement have been instrumental in developing new treatments and establishing standard of care therapy. While clinical trials strive to advance medical knowledge, they provide scientifically sound, state of the art care and their use should be increased. The Brain Tumor Cooperative Group, one such NCI-sponsored cooperative group, has been the primary group for the treatment of malignant gliomas. As the field of neuro-oncology expands, the neuroscience nurse needs to develop an understanding of clinical trials and their operation. The nurse is in an optimal position to support medical research and the research participant.

  10. Solid oxide fuel cell field trial evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Wilcox, C.P.; Winstanley, R.; Nietsch, T.; Smith, C.; Knight, R.; Seymore, C.

    2000-07-01

    This report focuses on issues relating to a field trial of a solid oxide fuel cell (SOFC). Aspects examined include markets for SOFC systems, the choice of systems for demonstration in year 2002, the assessment of industrial interest, and evaluation and ranking of candidate systems. The identification and evaluation of interest in field trials, the estimation of the capital and running costs of a field trial, and identification of the benefits to the UK and barriers to implementation of SOFC systems are discussed. (UK)

  11. Inherited Retinal Degenerative Clinical Trial Network

    Science.gov (United States)

    2009-10-01

    clinical efforts that will impact the NEER network going forward and laid the ground work for the CTECs to participate in ongoing clinical trials for...Clinical Implications: • How will the proposed clinical trial have a significant impact on disease outcome? 34 • How will the clinical trial offer...was 0 041U>< for pat<t!nts NPtS and <H08, 0 4 1ux !01 Ct 110, 1nd 10.0 lux f01 < H13 OJ)Ilo •her on~tion are indiuttd AhtrNtor19 stimuli Wl’f1! pres

  12. Provenance trials of larch in Siberia

    Energy Technology Data Exchange (ETDEWEB)

    Milyutin, L I [V.N. Sukachev Inst. of Forest SB RAS, Krasnoyarsk (Russian Federation)

    1996-12-31

    Some results of provenance trials of larch in Siberia are given. These provenance trials were established in the last thirty years by efforts of V.N. Sukaczev Inst. of Forest. Provenances and species of larch were tested in some field trials distributed over Siberia between Lat. N 52 deg and 66 deg, Long. E 88 deg and 113 deg: near Krasnoyarsk, in Republic Khakasia (an altitudes of 800 and 1200 metres), in the Lower Yenisei near Turukhansk, in the west and south regions of Krasnoyarsk territory, in the Upper Lena, near Chita. 2 refs

  13. [Multicenter randomized trial of amnioinfusion].

    Science.gov (United States)

    Fraser, W; Marcoux, S; Prendiville, W; Petrou, S; Hofmeyr, J; Reinharz, D; Goulet, C; Ohlsson, A

    2000-05-01

    Meconium staining of the amniotic fluid in labor is a frequent problem that is associated with an increase in the risk of neonatal and maternal morbidity. Amnioinfusion is a simple technique that is designed to prevent neonatal and maternal morbidity associated with meconium. Preliminary studies indicate that amnioinfusion is a promising approach to the prevention of such complications of labor. However, further research is required. The primary objective of this multi-centre randomized controlled study is to determine if amnioinfusion for thick meconium stained amniotic fluid results in a reduction in perinatal death or moderate to severe meconium aspiration syndrome. We will also assess the effects of amnioinfusion on other indicators of neonatal morbidity and on cesarean section. The study includes an evaluation of womens views on their childbirth experience and an economic evaluation of a policy of amnioinfusion The study will be achieved with the collaboration of approximately 50 obstetrical centres from across Canada, US, Europe, South America and South Africa. This multicentre trial will provide urgently needed information on the efficacy and effectiveness of amniofusion for the indication of meconium stained amniotic fluid.

  14. A Public Trial De Novo

    DEFF Research Database (Denmark)

    Vedel, Jane Bjørn; Gad, Christopher

    2011-01-01

    This article addresses the concept of “industrial interests” and examines its role in a topical controversy about a large research grant from a private foundation, the Novo Nordisk Foundation, to the University of Copenhagen. The authors suggest that the debate took the form of a “public trial” w.......” The article ends with a discussion of some implications of the analysis, including that policy making, academic research, and public debates might benefit from more detailed accounts of interests and stakes.......This article addresses the concept of “industrial interests” and examines its role in a topical controversy about a large research grant from a private foundation, the Novo Nordisk Foundation, to the University of Copenhagen. The authors suggest that the debate took the form of a “public trial......” where the grant and close(r) intermingling between industry and public research was prosecuted and defended. First, the authors address how the grant was framed in the media. Second, they redescribe the case by introducing new “evidence” that, because of this framing, did not reach “the court...

  15. IAEA monitoring field trials workshop

    International Nuclear Information System (INIS)

    Ross, H.H.; Cooley, J.N.; Belew, W.L.

    1995-01-01

    Recent safeguards inspections in Iraq and elsewhere by the International Atomic Energy Agency (IAEA) have led to the supposition that environmental monitoring can aid in verifying declared and in detecting undeclared nuclear activities or operations. This assumption was most recently examined by the IAEA's Standing Advisory Group on Safeguards Implementation (SAGSI), in their reports to the IAEA Board of Governors. In their reports, SAGSI suggested that further assessment and development of environmental monitoring would be needed to fully evaluate its potential application to enhanced IAEA safeguards. Such an inquiry became part of the IAEA ''Programme 93+2'' assessment of measures to enhance IAEA safeguards. In March, 1994, the International Safeguards Group at Oak Ridge hosted an environmental monitoring field trial workshop for IAEA inspectors to train them in the techniques needed for effective environmental sampling. The workshop included both classroom lectures and actual field sampling exercises. The workshop was designed to emphasize the analytical infrastructure needed for an environmental program, practical sampling methods, and suggested procedures for properly planning a sampling campaign. Detailed techniques for swipe, vegetation, soil, biota, and water associated sampling were covered. The overall approach to the workshop, and observed results, are described

  16. Field trials at Bikini Atoll

    International Nuclear Information System (INIS)

    Robison, William L.; Stone, Earl L.

    1987-01-01

    Last year's report summarized the status of both the long on-going soil and plant sampling programs (initiated by LLNL in 1978) and the field experiments aimed at reducing radionuclide levels in food plants to acceptable levels. In the current report the two are combined into a single summary table, indicating for each field trial or survey the results to date, information expected by the spring of 1988, and projection, if any, for continuation beyond FY1988. This table is therefore a comprehensive survey of the program and accordingly the individual items in it have been coded to facilitate reference to them. Analytical results from field studies installed in 1985 and 1986 are now providing much new information, briefly described below. In part, these results bear out or enlarge the hypotheses that prompted the studies. They also suggest how some treatments may be modified or combined for greater effectiveness. We shall discuss here certain groups of studies of immediate interest that deal with the blocking effects of potassium and other ions on cesium-137 uptake by plants, the effect of removing topsoil (excavation), cultural studies which involve the manipulation of the subsoil, plus some others

  17. Field trials at Bikini Atoll

    Energy Technology Data Exchange (ETDEWEB)

    Robison, William L [Lawrence Livermore National Laboratory, Environmental Sciences Division, Livermore, CA (United States); Stone, Earl L [University of Florida, Soil Science Department, Gainesville, FL (United States)

    1987-07-01

    Last year's report summarized the status of both the long on-going soil and plant sampling programs (initiated by LLNL in 1978) and the field experiments aimed at reducing radionuclide levels in food plants to acceptable levels. In the current report the two are combined into a single summary table, indicating for each field trial or survey the results to date, information expected by the spring of 1988, and projection, if any, for continuation beyond FY1988. This table is therefore a comprehensive survey of the program and accordingly the individual items in it have been coded to facilitate reference to them. Analytical results from field studies installed in 1985 and 1986 are now providing much new information, briefly described below. In part, these results bear out or enlarge the hypotheses that prompted the studies. They also suggest how some treatments may be modified or combined for greater effectiveness. We shall discuss here certain groups of studies of immediate interest that deal with the blocking effects of potassium and other ions on cesium-137 uptake by plants, the effect of removing topsoil (excavation), cultural studies which involve the manipulation of the subsoil, plus some others.

  18. Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials.

    Science.gov (United States)

    Schroen, Anneke T; Petroni, Gina R; Wang, Hongkun; Gray, Robert; Wang, Xiaofei F; Cronin, Walter; Sargent, Daniel J; Benedetti, Jacqueline; Wickerham, Donald L; Djulbegovic, Benjamin; Slingluff, Craig L

    2010-08-01

    A major challenge for randomized phase III oncology trials is the frequent low rates of patient enrollment, resulting in high rates of premature closure due to insufficient accrual. We conducted a pilot study to determine the extent of trial closure due to poor accrual, feasibility of identifying trial factors associated with sufficient accrual, impact of redesign strategies on trial accrual, and accrual benchmarks designating high failure risk in the clinical trials cooperative group (CTCG) setting. A subset of phase III trials opened by five CTCGs between August 1991 and March 2004 was evaluated. Design elements, experimental agents, redesign strategies, and pretrial accrual assessment supporting accrual predictions were abstracted from CTCG documents. Percent actual/predicted accrual rate averaged per month was calculated. Trials were categorized as having sufficient or insufficient accrual based on reason for trial termination. Analyses included univariate and bivariate summaries to identify potential trial factors associated with accrual sufficiency. Among 40 trials from one CTCG, 21 (52.5%) trials closed due to insufficient accrual. In 82 trials from five CTCGs, therapeutic trials accrued sufficiently more often than nontherapeutic trials (59% vs 27%, p = 0.05). Trials including pretrial accrual assessment more often achieved sufficient accrual than those without (67% vs 47%, p = 0.08). Fewer exclusion criteria, shorter consent forms, other CTCG participation, and trial design simplicity were not associated with achieving sufficient accrual. Trials accruing at a rate much lower than predicted (accrual rate) were consistently closed due to insufficient accrual. This trial subset under-represents certain experimental modalities. Data sources do not allow accounting for all factors potentially related to accrual success. Trial closure due to insufficient accrual is common. Certain trial design factors appear associated with attaining sufficient accrual. Defining

  19. Patient engagement in clinical trials: The Clinical Trials Transformation Initiative's leadership from theory to practical implementation.

    Science.gov (United States)

    Patrick-Lake, Bray

    2018-02-01

    Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative's role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts.

  20. Clinical trial data analysis using R

    National Research Council Canada - National Science Library

    Chen, Ding-Geng; Peace, Karl E

    2011-01-01

    .... Case studies demonstrate how to select the appropriate clinical trial data. The authors introduce the corresponding biostatistical analysis methods, followed by the step-by-step data analysis using R...