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 ...

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.

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.

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…

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...

Four Educators in Plato's "Theaetetus"

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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'…

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

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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…

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

Evaluating PLATO: postgraduate teaching and learning online.

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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.

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

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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.

Expected asteroseismic performances with the space project PLATO

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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.

Quoting Plato in Porphyrius' Cuestiones homericas

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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.

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.

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

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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.

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....

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

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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…

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)

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

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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.

THE JOURNEY OF TRUTH: FROM PLATO TO ZOLA

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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.

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.

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.

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...

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

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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.

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

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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.

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…

Plato: from Socrates to Pre-Socratics?

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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.

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"

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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…

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 ...

Three Misunderstandings of Plato's Theory of Moral Education

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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…

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…

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.

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...

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…

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...

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

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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…

Socrates the Pythagorean: an Invention of Plato?

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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

Ancient Doctrines of Passions: Plato and Aristotle

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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.

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

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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.

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…

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

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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…

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

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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.

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...

Approach to the problem of motion in Plato

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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

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.

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.

Pemikiran Epistemologi Barat: dari Plato Sampai Gonseth

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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.

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

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

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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.

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 ...

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…

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.

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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

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

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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…

[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.

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

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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…

What Plato and Murdoch Think About Love

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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.

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.

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

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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

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…

Infância e educação em Platão Childhood and education in Plato

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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.

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.

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....

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

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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.

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.

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.

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

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

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

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…

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

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.

[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.

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

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....

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)

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.

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?

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,…

Within- and across-trial dynamics of human EEG reveal cooperative interplay between reinforcement learning and working memory.

Science.gov (United States)

Collins, Anne G E; Frank, Michael J

2018-03-06

Learning from rewards and punishments is essential to survival and facilitates flexible human behavior. It is widely appreciated that multiple cognitive and reinforcement learning systems contribute to decision-making, but the nature of their interactions is elusive. Here, we leverage methods for extracting trial-by-trial indices of reinforcement learning (RL) and working memory (WM) in human electro-encephalography to reveal single-trial computations beyond that afforded by behavior alone. Neural dynamics confirmed that increases in neural expectation were predictive of reduced neural surprise in the following feedback period, supporting central tenets of RL models. Within- and cross-trial dynamics revealed a cooperative interplay between systems for learning, in which WM contributes expectations to guide RL, despite competition between systems during choice. Together, these results provide a deeper understanding of how multiple neural systems interact for learning and decision-making and facilitate analysis of their disruption in clinical populations.

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)

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

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Jernej Pisk

2006-02-01

toward the fulfillment of self, all the way to the ideal – the idea itself. And only sport like that can bring true contentment to the human – the reasonable being. With this sport is essentially intervening in the sphere of philosophical cognition. The goodness of sport is no more determined by physical dimensions of space and time, but indeed, as Plato shows, the true good sport goes beyond these borders. In this manner sport goes beyond the physical world and touches the everlasting and unchangeable world of ideas. And the world of ideas is for Plato tópos where the very truth reveals itself. So, sport could be a useful means for the philosophical investigation of humans and the world. Jednou z nejobvyklejších Platónových otázek, které nacházíme v jeho dialozích, je "Co je něco?" Touto otázkou většinou Platón přiměl své protějšky k uznání, že ve skutečnosti úplně nerozumí tomu, co je čím, přestože částečně tomu rozumí. Uvědomění si svého neúplného chápání je prvním krokem na filosofické cestě k pravdě. Stejně jako ve starověku se dnes Platón táže i nás – moderní filosofy sportu – "Co je to sport?" nebo lépe "Co je to dobrý sport?" Pravděpodobně nejlepší Platónovu odpověď na tuto otázku lze nalézt v základních konceptech jeho filosofie týkající se hierarchického rozdělení státu a lidské duše do tří úrovní. Vzhledem k tomu, že sport je odvozen od člověka, může být také prospěšnost sportu rozdělena do tří úrovní. Nejnižší úroveň sportu odpovídá první části duše – žádostivé duši. Na této úrovni je sport založen na získávání materiálních statků v podobě cen na soutěžích. Z filosofického hlediska je to nejnižší možnou úrovní prospěšnosti sportu. Druhá úroveň sportu odpovídá druhé části duše – emocionální duši. Sport je na této úrovni založen na elementárním starověkém agónu, který se snaží dojít napln

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

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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.

Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses

DEFF Research Database (Denmark)

Brok, J.; Thorlund, K.; Gluud, C.

2008-01-01

in 80% (insufficient information size). TSA(15%) and TSA(LBHIS) found that 95% and 91% had absence of evidence. The remaining nonsignificant meta-analyses had evidence of lack of effect. CONCLUSION: TSA reveals insufficient information size and potentially false positive results in many meta......OBJECTIVES: To evaluate meta-analyses with trial sequential analysis (TSA). TSA adjusts for random error risk and provides the required number of participants (information size) in a meta-analysis. Meta-analyses not reaching information size are analyzed with trial sequential monitoring boundaries...... analogous to interim monitoring boundaries in a single trial. STUDY DESIGN AND SETTING: We applied TSA on meta-analyses performed in Cochrane Neonatal reviews. We calculated information sizes and monitoring boundaries with three different anticipated intervention effects of 30% relative risk reduction (TSA...

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...

Platonic Dialogue, Maieutic Method and Critical Thinking

Science.gov (United States)

Leigh, Fiona

2007-01-01

In this paper I offer a reading of one of Plato's later works, the "Sophist", that reveals it to be informed by principles comparable on the face of it with those that have emerged recently in the field of critical thinking. As a development of the famous Socratic method of his teacher, I argue, Plato deployed his own pedagogical method, a…

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.

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.

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.

Trial-by-Trial Modulation of Associative Memory Formation by Reward Prediction Error and Reward Anticipation as Revealed by a Biologically Plausible Computational Model.

Science.gov (United States)

Aberg, Kristoffer C; Müller, Julia; Schwartz, Sophie

2017-01-01

Anticipation and delivery of rewards improves memory formation, but little effort has been made to disentangle their respective contributions to memory enhancement. Moreover, it has been suggested that the effects of reward on memory are mediated by dopaminergic influences on hippocampal plasticity. Yet, evidence linking memory improvements to actual reward computations reflected in the activity of the dopaminergic system, i.e., prediction errors and expected values, is scarce and inconclusive. For example, different previous studies reported that the magnitude of prediction errors during a reinforcement learning task was a positive, negative, or non-significant predictor of successfully encoding simultaneously presented images. Individual sensitivities to reward and punishment have been found to influence the activation of the dopaminergic reward system and could therefore help explain these seemingly discrepant results. Here, we used a novel associative memory task combined with computational modeling and showed independent effects of reward-delivery and reward-anticipation on memory. Strikingly, the computational approach revealed positive influences from both reward delivery, as mediated by prediction error magnitude, and reward anticipation, as mediated by magnitude of expected value, even in the absence of behavioral effects when analyzed using standard methods, i.e., by collapsing memory performance across trials within conditions. We additionally measured trait estimates of reward and punishment sensitivity and found that individuals with increased reward (vs. punishment) sensitivity had better memory for associations encoded during positive (vs. negative) prediction errors when tested after 20 min, but a negative trend when tested after 24 h. In conclusion, modeling trial-by-trial fluctuations in the magnitude of reward, as we did here for prediction errors and expected value computations, provides a comprehensive and biologically plausible description of

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.

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.

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.

Mimesis in Bible Didactics – an outline in the context of religious ...

African Journals Online (AJOL)

2015-10-23

Oct 23, 2015 ... How to cite this article: Zimmermann, M. ... are central to the third book of Plato's Res Publica and reveals the .... type of depiction and reference brings it into the present ..... W.H. Fyfe, Harvard University Press, Cambridge, MA/.

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.

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

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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

Význam čísel mezi Platónem a Aristotelem

OpenAIRE

Šíma, Antonín

2016-01-01

1 Abstract Meaning of numbers between Plato and Aristotle Antonín Šíma The dissertation titled "The Transformation of the Concept of Number between Plato and the Early Academy" deals with the problem of numbers in early Platonism between Aristotle and Plato. In Plato's dialogues, within professional mathematical disciplines of knowledge, numbers fulfil a function of propaedeutic procedure to the method of thinking − dialectic. Dialectic engages in the most general structures of thinking whose...

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

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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.

Srovnání Platónova a Aristotelova pojetí etiky ctnosti

OpenAIRE

TISCHLEROVÁ, Monika

2014-01-01

This work deals with the comparison of Plato and Aristotle's conception of virtue ethics. The first part describes Plato's view of this area of philosophy. Plato puts his ethics based on the analogy between the municipality and the soul. Plato also operates with good ideas. In the second part, Aristotle view. First, I discuss the objectives of its philosophy, which is good, and then bliss. Then there is the division of the moral virtues and intellectual. Then describe each of Aristotle's virt...

Results of an Oncology Clinical Trial Nurse Role Delineation Study.

Science.gov (United States)

Purdom, Michelle A; Petersen, Sandra; Haas, Barbara K

2017-09-01

To evaluate the relevance of a five-dimensional model of clinical trial nursing practice in an oncology clinical trial nurse population. 
. Web-based cross-sectional survey.
. Online via Qualtrics.
. 167 oncology nurses throughout the United States, including 41 study coordinators, 35 direct care providers, and 91 dual-role nurses who provide direct patient care and trial coordination.
. Principal components analysis was used to determine the dimensions of oncology clinical trial nursing practice.
. Self-reported frequency of 59 activities.
. The results did not support the original five-dimensional model of nursing care but revealed a more multidimensional model.
. An analysis of frequency data revealed an eight-dimensional model of oncology research nursing, including care, manage study, expert, lead, prepare, data, advance science, and ethics.
. This evidence-based model expands understanding of the multidimensional roles of oncology nurses caring for patients with cancer enrolled in clinical trials.

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

The search for virtue

Directory of Open Access Journals (Sweden)

Nikitović Aleksandar

2011-01-01

Full Text Available In the combat for virtue, waged between Plato and the Sophists, Plato was striving to keep the contents of old Hellenic ethics, but not their mythical form, where Sophism discovered significant shortcomings and thanks to that challenged the whole contents of old Hellenic ethics. On the other hand, Plato accepted the new form of rational thinking, but not the dismantling unilateralism of Sohpism rationality. In other words, Plato embarked on theoreticizing the contents of old Hellenic ethics, aspiring to reconcile the fundamental principle of traditional view of the world with the new ruling form of thinking.

[Feelings as considered by preplatonic and contemporary philosophers--coincidence or influence?].

Science.gov (United States)

Zaborowski, Robert

2007-01-01

Feelings' role in ancient Greek conceptions up till now has not become clear. As far as the researchers of antiquity are interested in Aristotle's and Hellenistic philosophers, Plato's and his predecessors has not been analysed from this point of view yet. It is often connected with a fact that Preplatonic philosophy is so-called philosophy of physis, and/or its nature is exclusively rationalistic. Thanks to the analysis of three passages (Heraclitus fr. B 85, Parmenides fr. B 3 and Democritus fr. B 31), and multilevel interpretation of Plato's conception one can indicate--if focus one's attention on the elements concerning the affectivity--the similarities to contemporary philosophers' outlooks. Among others, they concern 1) Heraclitus (and Parmenides fr. B 1, 1) versus Hume, Pascal, Ribot, Brentano, Bergson, 2) Parmenides versus Descartes, 3) Democritus versus Ribot, 4) Plato versus Scheler and Hartmann. Such analyses and interpretations let conquer conventional thinking of the Greek emotionality issue, because on the one hand they reveal a kind of deformations and misconstructions in searches, and on the other show a current importance of ancient conceptions. In support of the statement it is worth reminding of the formulation emotional intelligence that recently has enjoyed great popularity. His origins can be found already in Greek philosophers' thought.

Searching for cures: Inner-city and rural patients' awareness and perceptions of cancer clinical trials

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Mugur Geana

2017-03-01

Full Text Available Fewer than 5% of cancer patients participate in clinical trials, making it challenging to test new therapies or interventions for cancer. Even within that small number, patients living in inner-city and rural areas are underrepresented in clinical trials. This study explores cancer patients' awareness and perceptions of cancer clinical trials, as well as their perceptions of patient-provider interactions related to discussing cancer clinical trials in order to improve accrual in cancer clinical trials. Interviews with 66 former and current in inner-city and rural cancer patients revealed a lack of awareness and understanding about clinical trials, as well as misconceptions about what clinical trials entail. Findings also revealed that commercials and television shows play a prominent role in forming inner-city and rural patients' attitudes and/or misconceptions about clinical trials. However, rural patients were more likely to hold unfavorable views about clinical trials than inner-city patients. Patient-provider discussions emerged as being crucial for increasing awareness of clinical trials among patients and recruiting them to trials. Findings from this study will inform communication strategies to enhance recruitment to cancer clinical trials by increasing awareness and countering misconceptions about clinical trials.

The Impacts of Corruption on Economic Development in Afghanistan: A Study of the Effects of Nepotism and Bribery

Science.gov (United States)

2011-12-16

corruption as it changes over time. He references philosophers such as Plato , Aristotle and Machiavelli.2 Plato introduces the initial analyses of...corruption as human flaw introduced into governments that distorts and perverts them. Aristotle takes Plato further by identifying the transformation...reemphasizes that while corrupt practices are condoned and rationalized , more damaging forms of corruption will become acceptable. Corruption can co-exist with

Perfect and imperfect states

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Nikitović Aleksandar

2013-01-01

Full Text Available Early Greek ethics embodied in Cretan and Spartan mores, served as a model for Plato`s political theory. Plato theorized the contents of early Greek ethics, aspiring to justify and revitalize the fundamental principles of a traditional view of the world. However, according to Plato`s new insight, deed is further from the truth than a thought i.e. theory. The dorian model had to renounce its position to the perfect prototype of a righteous state, which is a result of the inner logic of philosophical theorizing in early Greek ethics. Prototype and model of philosophical reflection, in comparison to philosophical theory, becomes minor and deficient. Philosophical theorizing of early Greek ethics philosophically formatted Greek heritage, initiating substantial changes to the content of traditional ethics. Replacement of the myth with ontology, as a new foundation of politics, transformed early Greek ethics in various relevant ways. [Projekat Ministarstva nauke Republike Srbije, br. 179049

Rozdíly v chápání ctnosti u Platóna, Aristotela a Aurelia Augustina

OpenAIRE

Kavanová, Blanka

2011-01-01

Bachelor's Thesis: Difference in Plato's, Aristotle's and Aurelius Augustinus' Understanding to Virtue Name: Blanka Kavanová Faculty: Faculty of Education, Charles University in Prague Department of Social Sciences and Philosophy Year: 2011 ABSTRACT The bachelor's thesis is concerned with the development and differences in Plato's, Aristotle's and Aurelius Augustinus' concept of virtue. The first part is focused on Plato's concept of four basic virtues, i.e. moderation/reasonableness, justice...

A Brief Prehistory of Philosophical Paraconsistency

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William H. F. Altman

2010-04-01

Full Text Available In celebration of Newton da Costa’s place in the history of paraconsistency, this paper considers the use and abuse of deliberate self-contradiction. Beginning with Parmenides, developed by Plato, and continued by Cicero, an ancient philosophical tradition used deliberately paraconsistent discourses to reveal the truth. In modern times, decisionism has used deliberate self-contradiction against Judeo-Christian revelation.

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

Book of Abstracts, Logic Colloquium 󈨦, the ASL European Summer Meeting, August 9-15, 1998, Prague, Czech Republic.

Science.gov (United States)

1998-09-23

the First Hypothesis of Plato’s Parmenides and the Undecidable Sentence of Kurt Godel 155 D. Drai Concepts of validity 156 M. L Zelbert, Logical...account of mathematics in the "Tractatus". -154- LC 󈨦 Book of Abstracts A Comparison Between the First Hypothesis of Plato’s Parmenides and the...42)(05)43129386 svandova@jumbo.ped.muni.cz in the second half of the twentieth century there has been a revival of interest in Plato’s Parmenides

Can virtue be taught?

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Nikitović Aleksandar

2009-01-01

Full Text Available The teachability of virtue is an issue on which were crossed swords during the struggle for supremacy between two basic principles of ancient Greek spirit - sophistry and ancient Greek ethics. Two great representatives of these opposite principles, Plato and Protagoras, confronted their arguments in Plato's dialog named after the great sophist. Paradoxically, during this philosophical struggle, Protagoras, who at the beginning supposed that virtue is teachable, later, on the contrary, states that virtue is not knowledge and this would make it least likely to be teachable. On the other hand Plato, who is trying to preserve the ancient Greek principle that virtue is innate, claims that virtue is knowledge. The solution of this great dispute between two principles of antiquity Plato sees in philosophical theoretization of ancient Greek mythical worldview.

Unfulfilled translation opportunities in industry sponsored clinical trials

DEFF Research Database (Denmark)

Smed, Marie; Getz, Kenneth A.

2013-01-01

in the industry and site representatives are changing. The process of clinical trials has increased in complexity over the years, resulting in additional management layers. Besides an increase in internal management layers, sponsors often also outsource various tasks related to clinical trials to a CRO (Contract...... Research Organization) and thereby adding another link in the relationships between site and sponsor. These changes are intended to optimize the time-consuming and costly trial phases; however, there is a need to study whether valuable knowledge and experience is compromised in the process. Limited......' knowledge gained in clinical trials is utilized by the industry. Responses from 451 global investigative site representatives are included in the study. The analysis of the extensive dataset reveals that the current processes of collaboration between sites and the industry restrict the leverage of valuable...

Rotaryst lahkunud Valev Platot ümbritsevad segased rahaasjad / Nils Niitra

Index Scriptorium Estoniae

Niitra, Nils, 1975-

2004-01-01

Endine kaitseministri nõunik Valev Plato lahkus Rotary klubi liikmete ridadest. 2003. aastal kõrvaldati ta Tartu Ülikooli Kääriku spordibaasi direktori ametikohalt segaduste tõttu rahaasjades. Tartu Rotary klubi presidendi Andrus Ansipi arvamus Plato klubist lahkumise kohta

The Possibility of Phenomenology in Heidegger

African Journals Online (AJOL)

denise

“democracy to come has always been suicidal” (read: not “life-assured”) .... Plato and Aristotle: “Phenomenology radicalized in ... of Plato and Aristotle brought back to life: the repetition, the ..... notwithstanding, simply to fight the fight is to lose it.

"I will miss the study, God bless you all": participation in a nutritional chemoprevention trial.

Science.gov (United States)

Moreno-Black, Geraldine; Shor-Posner, Gail; Miguez, Maria-Jose; Burbano, Ximena; O'Mellan, Sandra; Yovanoff, P

2004-01-01

Randomized controlled clinical trials are often considered to be the "gold standard" for health research. Consequently, understanding the reasons people participate in these trials, especially minority groups who are often under-represented in clinical trials, or populations who have chronic illnesses or abuse drugs, is salient for successful recruitment, retention, and project design. This paper describes the results of a study that was designed to examine some of the ways in which participants in a randomized double blind clinical trial perceived their participation in the clinical trial, and the reasons they gave for continuing in the study. All of the participants were individuals who were using drugs and were infected with the HIV-1 virus, and had participated in a chemoprevention trial. The data from an exit interview were analyzed thematically in order to reveal units of meaning concerning participation and continuation in the clinical trial. The analysis revealed 3 higher-level concepts, or themes, that guided participation: increased health awareness, personal enhancement, and sociability. The data clearly indicated that involvement and retention in the trial were directly related to the ways in which the participants interpreted the study, perceived the benefits they derived from participating, and imbued their participation with value so that it was important and relevant to their own perceptions of health, as well as personal and social well being.

Newton's Metaphysics of Space as God's Emanative Effect

Science.gov (United States)

Jacquette, Dale

2014-09-01

In several of his writings, Isaac Newton proposed that physical space is God's "emanative effect" or "sensorium," revealing something interesting about the metaphysics underlying his mathematical physics. Newton's conjectures depart from Plato and Aristotle's metaphysics of space and from classical and Cambridge Neoplatonism. Present-day philosophical concepts of supervenience clarify Newton's ideas about space and offer a portrait of Newton not only as a mathematical physicist but an independent-minded rationalist philosopher.

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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Mauro Bonazzi

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

Monologue à plusiers voix : Montaigne et le dialogue

DEFF Research Database (Denmark)

Toftgaard, Anders

2010-01-01

dissatisfaction with Plato's dialogues, he aspired to match Plato's style, not least in achieving a conversational tone. Three different elements of dialogue are analysed : the “Dialogue of One“ between the different parts of Montaigne's mind, the dialogue between the author and the writers quoted and paraphrased...

Reassessing Phase II Heart Failure Clinical Trials: Consensus Recommendations

Science.gov (United States)

Butler, Javed; Hamo, Carine E.; Udelson, James E.; O’Connor, Christopher; Sabbah, Hani N.; Metra, Marco; Shah, Sanjiv J.; Kitzman, Dalane W.; Teerlink, John; Bernstein, Harold S.; Brooks, Gabriel; Depre, Christophe; DeSouza, Mary M.; Dinh, Wilfried; Donovan, Mark; Frische-Danielson, Regina; Frost, Robert J.; Garza, Dahlia; Gohring, Udo-Michael; Hellawell, Jennifer; Hsia, Judith; Ishihara, Shiro; Kay-Mugford, Patricia; Koglin, Joerg; Kozinn, Marc; Larson, Christopher J.; Mayo, Martha; Gan, Li-Ming; Mugnier, Pierrre; Mushonga, Sekayi; Roessig, Lothar; Russo, Cesare; Salsali, Afshin; Satler, Carol; Shi, Victor; Ticho, Barry; van der Laan, Michael; Yancy, Clyde; Stockbridge, Norman; Gheorghiade, Mihai

2017-01-01

The increasing burden and the continued suboptimal outcomes for patients with heart failure underlines the importance of continued research to develop novel therapeutics for this disorder. This can only be accomplished with successful translation of basic science discoveries into direct human application through effective clinical trial design and execution that results in a substantially improved clinical course and outcomes. In this respect, phase II clinical trials play a pivotal role in determining which of the multitude of potential basic science discoveries should move to the large and expansive registration trials in humans. A critical examination of the phase II trials in heart failure reveals multiple shortcomings in their concept, design, execution, and interpretation. To further a dialogue regarding the challenges and potential for improvement and the role of phase II trials in patients with heart failure, the Food and Drug Administration facilitated a meeting on October 17th 2016 represented by clinicians, researchers, industry members, and regulators. This document summarizes the discussion from this meeting and provides key recommendations for future directions. PMID:28356300

Computer-Based Legal Education at the University of Illinois: A Report of Two Years' Experience

Science.gov (United States)

Maggs, Peter B.; Morgan, Thomas D.

1975-01-01

Describes experimentation with the Plato IV computer-assisted method of teaching law at the University of Illinois College of Law: development and testing of programs for teaching Future Interests and Offer and Acceptance, and law-related work currently being done on Plato. Potential, limitations, and student enthusiasm are summarized. (JT)

Response to Mackenzie

Science.gov (United States)

Peers, Chris

2014-01-01

Chris Peers begins his response to Jim Mackenzie's article, "Peers on Socrates and Plato" by asking "What is the 'masculine imaginary?'" Peers defines the term "imaginary" as it is applied in his article, "Freud, Plato and Irigaray: A Morpho-Logic of Teaching and Learning" (2012) and draws…

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“

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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.

A Rather Intelligent Language Teacher.

Science.gov (United States)

Cerri, Stefano; Breuker, Joost

1981-01-01

Characteristics of DART (Didactic Augmented Recursive Transition), an ATN-based system for writing intelligent computer assisted instruction (ICAI) programs that is available on the PLATO system are described. DART allows writing programs in an ATN dialect, compiling them in machine code for the PLATO system, and executing them as if the original…

The Test Matters: The Relationship between Classroom Observation Scores and Teacher Value Added on Multiple Types of Assessment

Science.gov (United States)

Grossman, Pam; Cohen, Julie; Ronfeldt, Matthew; Brown, Lindsay

2014-01-01

In this study, we examined how the relationships between one observation protocol, the Protocol for Language Arts Teaching Observation (PLATO), and value-added measures shift when different tests are used to assess student achievement. Using data from the Measures of Effective Teaching Project, we found that PLATO was more strongly related to the…

How we choose one over another: predicting trial-by-trial preference decision.

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Vidya Bhushan

Full Text Available Preference formation is a complex problem as it is subjective, involves emotion, is led by implicit processes, and changes depending on the context even within the same individual. Thus, scientific attempts to predict preference are challenging, yet quite important for basic understanding of human decision making mechanisms, but prediction in a group-average sense has only a limited significance. In this study, we predicted preferential decisions on a trial by trial basis based on brain responses occurring before the individuals made their decisions explicit. Participants made a binary preference decision of approachability based on faces while their electrophysiological responses were recorded. An artificial neural network based pattern-classifier was used with time-frequency resolved patterns of a functional connectivity measure as features for the classifier. We were able to predict preference decisions with a mean accuracy of 74.3 ± 2.79% at participant-independent level and of 91.4 ± 3.8% at participant-dependent level. Further, we revealed a causal role of the first impression on final decision and demonstrated the temporal trajectory of preference decision formation.

Developments in clinical trials: a Pharma Matters report.

Science.gov (United States)

Arjona, A; Nuskey, B; Rabasseda, X; Arias, E

2014-08-01

As the pharmaceutical industry strives to meet the ever-increasing complexity of drug development, new technology in clinical trials has become a beacon of hope. With big data comes the promise of accelerated patient recruitment, real-time monitoring of clinical trials, bioinformatics empowerment of quicker phase progression, and the overwhelming benefits of precision medicine for select trials. Risk-based monitoring stands to benefit as well. With a strengthening focus on centralized data by the FDA and industry's transformative initiative, TransCelerate, a new era in trial risk mitigation has begun. The traditional method of intensive on-site monitoring is becoming a thing of the past as statistical, real-time analysis of site and trial-wide data provides the means to monitor with greater efficiency and effectiveness from afar. However, when it comes to big data, there are challenges that lie ahead. Patient privacy, commercial investment protection, technology woes and data variability are all limitations to be met with considerable thought. At the Annual Meeting of the American Academy of Dermatology this year, clinical trials on psoriasis, atopic dermatitis and other skin diseases were discussed in detail. This review of clinical research reports on novel therapies for psoriasis and atopic dermatitis reveals the impact of these diseases and the drug candidates that have been successful in phase II and III studies. Data-focused highlights of novel dermatological trials, as well as real-life big data approaches and an insight on the new methodology of risk-based monitoring, are all discussed in this edition of Developments in Clinical Trials. Copyright 2014 Prous Science, S.A.U. or its licensors. All rights reserved.

The natural history of conducting and reporting clinical trials: interviews with trialists.

Science.gov (United States)

Smyth, Rebecca M D; Jacoby, Ann; Altman, Douglas G; Gamble, Carrol; Williamson, Paula R

2015-01-26

To investigate the nature of the research process as a whole, factors that might influence the way in which research is carried out, and how researchers ultimately report their findings. Semi-structured qualitative telephone interviews with authors of trials, identified from two sources: trials published since 2002 included in Cochrane systematic reviews selected for the ORBIT project; and trial reports randomly sampled from 14,758 indexed on PubMed over the 12-month period from August 2007 to July 2008. A total of 268 trials were identified for inclusion, 183 published since 2002 and included in the Cochrane systematic reviews selected for the ORBIT project and 85 randomly selected published trials indexed on PubMed. The response rate from researchers in the former group was 21% (38/183) and in the latter group was 25% (21/85). Overall, 59 trialists were interviewed from the two different sources. A number of major but related themes emerged regarding the conduct and reporting of trials: establishment of the research question; identification of outcome variables; use of and adherence to the study protocol; conduct of the research; reporting and publishing of findings. Our results reveal that, although a substantial proportion of trialists identify outcome variables based on their clinical experience and knowing experts in the field, there can be insufficient reference to previous research in the planning of a new trial. We have revealed problems with trial recruitment: not reaching the target sample size, over-estimation of recruitment potential and recruiting clinicians not being in equipoise. We found a wide variation in the completeness of protocols, in terms of detailing study rationale, outlining the proposed methods, trial organisation and ethical considerations. Our results confirm that the conduct and reporting of some trials can be inadequate. Interviews with researchers identified aspects of clinical research that can be especially challenging

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

Joint cross-correlation analysis reveals complex, time-dependent functional relationship between cortical neurons and arm electromyograms

Science.gov (United States)

Zhuang, Katie Z.; Lebedev, Mikhail A.

2014-01-01

Correlation between cortical activity and electromyographic (EMG) activity of limb muscles has long been a subject of neurophysiological studies, especially in terms of corticospinal connectivity. Interest in this issue has recently increased due to the development of brain-machine interfaces with output signals that mimic muscle force. For this study, three monkeys were implanted with multielectrode arrays in multiple cortical areas. One monkey performed self-timed touch pad presses, whereas the other two executed arm reaching movements. We analyzed the dynamic relationship between cortical neuronal activity and arm EMGs using a joint cross-correlation (JCC) analysis that evaluated trial-by-trial correlation as a function of time intervals within a trial. JCCs revealed transient correlations between the EMGs of multiple muscles and neural activity in motor, premotor and somatosensory cortical areas. Matching results were obtained using spike-triggered averages corrected by subtracting trial-shuffled data. Compared with spike-triggered averages, JCCs more readily revealed dynamic changes in cortico-EMG correlations. JCCs showed that correlation peaks often sharpened around movement times and broadened during delay intervals. Furthermore, JCC patterns were directionally selective for the arm-reaching task. We propose that such highly dynamic, task-dependent and distributed relationships between cortical activity and EMGs should be taken into consideration for future brain-machine interfaces that generate EMG-like signals. PMID:25210153

Clinical Trials

Medline Plus

Full Text Available ... Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial ... clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical trial's protocol describes what ...

The Legitimization of Dialectic: Socratic Strategy in the "Gorgias."

Science.gov (United States)

Palmerton, Patricia

In the "Gorgias," Plato focuses attention upon the value of dialectic as opposed to rhetoric, as well as the status of orators as opposed to philosophers. Through his agent, Socrates, Plato confirms dialectic as a legitimate endeavor while calling into question the place of rhetoric. Socrates is portrayed as a director who enacts a…

The Inner (and Unavoidable?) Violence of Reason: Re-Reading Heidegger via Education

Science.gov (United States)

d'Agnese, Vasco

2015-01-01

Since Plato, Western thought has framed knowing as a method within "some realm of what is" and a predetermined "sphere of objects". The roots and the consequences of this stance towards reason and truth were noted by Heidegger, who equates the history of Western thought with the history of metaphysics. Since Plato, truth has…

Clinical Trials

Medline Plus

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 ...

Motivators to participation in actual HIV vaccine trials.

Science.gov (United States)

Dhalla, Shayesta; Poole, Gary

2014-02-01

An examination of actual HIV vaccine trials can contribute to an understanding of motivators for participation in these studies. Analysis of these motivators reveals that they can be categorized as social and personal benefits. Social benefits are generally altruistic, whereas personal benefits are psychological, physical, and financial. In this systematic review, the authors performed a literature search for actual preventive HIV vaccine trials reporting motivators to participation. Of studies conducted in the Organization for Economic Co-operation and Development (OECD) countries, the authors retrieved 12 studies reporting on social benefits and seven reporting on personal benefits. From the non-OECD countries, nine studies reported on social benefits and eight studies on personal benefits. Social benefits were most frequently described on macroscopic, altruistic levels. Personal benefits were most frequently psychological in nature. Rates of participation were compared between the OECD and the non-OECD countries. Knowledge of actual motivators in specific countries and regions can help target recruitment in various types of actual HIV vaccine trials.

Cross-species infection trials reveal cryptic parasite varieties and a putative polymorphism shared among host species.

Science.gov (United States)

Luijckx, Pepijn; Duneau, David; Andras, Jason P; Ebert, Dieter

2014-02-01

A parasite's host range can have important consequences for ecological and evolutionary processes but can be difficult to infer. Successful infection depends on the outcome of multiple steps and only some steps of the infection process may be critical in determining a parasites host range. To test this hypothesis, we investigated the host range of the bacterium Pasteuria ramosa, a Daphnia parasite, and determined the parasites success in different stages of the infection process. Multiple genotypes of Daphnia pulex, Daphnia longispina and Daphnia magna were tested with four Pasteuria genotypes using infection trials and an assay that determines the ability of the parasite to attach to the hosts esophagus. We find that attachment is not specific to host species but is specific to host genotype. This may suggest that alleles on the locus controlling attachment are shared among different host species that diverged 100 million year. However, in our trials, Pasteuria was never able to reproduce in nonnative host species, suggesting that Pasteuria infecting different host species are different varieties, each with a narrow host range. Our approach highlights the explanatory power of dissecting the steps of the infection process and resolves potentially conflicting reports on parasite host ranges. © 2013 The Author(s). Evolution © 2013 The Society for the Study of Evolution.

Genomic Selection in Multi-environment Crop Trials.

Science.gov (United States)

Oakey, Helena; Cullis, Brian; Thompson, Robin; Comadran, Jordi; Halpin, Claire; Waugh, Robbie

2016-05-03

Genomic selection in crop breeding introduces modeling challenges not found in animal studies. These include the need to accommodate replicate plants for each line, consider spatial variation in field trials, address line by environment interactions, and capture nonadditive effects. Here, we propose a flexible single-stage genomic selection approach that resolves these issues. Our linear mixed model incorporates spatial variation through environment-specific terms, and also randomization-based design terms. It considers marker, and marker by environment interactions using ridge regression best linear unbiased prediction to extend genomic selection to multiple environments. Since the approach uses the raw data from line replicates, the line genetic variation is partitioned into marker and nonmarker residual genetic variation (i.e., additive and nonadditive effects). This results in a more precise estimate of marker genetic effects. Using barley height data from trials, in 2 different years, of up to 477 cultivars, we demonstrate that our new genomic selection model improves predictions compared to current models. Analyzing single trials revealed improvements in predictive ability of up to 5.7%. For the multiple environment trial (MET) model, combining both year trials improved predictive ability up to 11.4% compared to a single environment analysis. Benefits were significant even when fewer markers were used. Compared to a single-year standard model run with 3490 markers, our partitioned MET model achieved the same predictive ability using between 500 and 1000 markers depending on the trial. Our approach can be used to increase accuracy and confidence in the selection of the best lines for breeding and/or, to reduce costs by using fewer markers. Copyright © 2016 Oakey et al.

SPIRIT trial: A phase III pragmatic trial of an advance care planning intervention in ESRD.

Science.gov (United States)

Song, Mi-Kyung; Unruh, Mark L; Manatunga, Amita; Plantinga, Laura C; Lea, Janice; Jhamb, Manisha; Kshirsagar, Abhijit V; Ward, Sandra E

2018-01-01

Advance care planning (ACP) is a central tenet of dialysis care, but the vast majority of dialysis patients report never engaging in ACP discussions with their care providers. Over the last decade, we have developed and iteratively tested SPIRIT (Sharing Patient's Illness Representation to Increase Trust), a theory-based, patient- and family-centered advance care planning intervention. SPIRIT is a six-step, two-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates. In these explanatory trials, SPIRIT was delivered by trained research nurses. Findings consistently revealed that patients and surrogates in SPIRIT showed significant improvement in preparedness for end-of-life decision making, and surrogates in SPIRIT reported significantly improved post-bereavement psychological outcomes after the patient's death compared to a no treatment comparison condition. As a critical next step, we are conducting an effectiveness-implementation study. This study is a multicenter, clinic-level cluster randomized pragmatic trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics, compared to usual care plus delayed SPIRIT implementation. Simultaneously, we will evaluate the implementation of SPIRIT, including sustainability. We will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from 30 dialysis clinics in four states. This trial of SPIRIT will generate novel, meaningful insights about improving ACP in dialysis care. ClinicalTrials.govNCT03138564, registered 05/01/2017. Copyright © 2017 Elsevier Inc. All rights reserved.

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

Development of a cancer clinical trials multi-media intervention: clinical trials: are they right for you?

Science.gov (United States)

Wells, Kristen J; Quinn, Gwendolyn P; Meade, Cathy D; Fletcher, Michelle; Tyson, Dinorah Martinez; Jim, Heather; Jacobsen, Paul B

2012-08-01

To describe processes used to develop a multi-media psycho-educational intervention to prepare patients for a discussion about cancer clinical trials (CTs). Guided by a Steering Committee, formative research was conducted to develop an informative and engaging tool about cancer CTs. Twenty-three patients and caregivers participated in formative in-depth interviews to elicit information about perceptions of cancer CTs to inform production of a new media product. Formative research revealed participants had concerns about experimentation, held beliefs that cancer CTs were for patients who had no other treatment options, and wanted a balance of information about pros and cons of CT participation. The value of physicians as credible spokespersons and the use of patients as role-models were supported. Using iterative processes, the production team infused the results into creation of a multimedia psycho-educational intervention titled Clinical Trials: Are they Right for You? An intervention, developed through an iterative consumer-focused process involving multiple stakeholders and formative research, may result in an engaging informative product. If found to be efficacious, Clinical Trials: Are they Right for You? is a low-cost and easily disseminated multimedia psycho-educational intervention to assist cancer patients with making an informed decision about cancer CTs. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Single-trial regression elucidates the role of prefrontal theta oscillations in response conflict

Directory of Open Access Journals (Sweden)

Michael X Cohen

2011-02-01

Full Text Available In most cognitive neuroscience experiments there are many behavioral and experimental dynamics, and many indices of brain activity, that vary from trial to trial. For example, in studies of response conflict, conflict is usually treated as a binary variable (i.e., response conflict exists or does not in any given trial, whereas some evidence and intuition suggests that conflict may vary in intensity from trial to trial. Here we demonstrate that single-trial multiple regression of time-frequency electrophysiological activity reveals neural mechanisms of cognitive control that are not apparent in cross-trial averages. We also introduce a novel extension to oscillation phase coherence and synchronization analyses, based on weighted phase modulation, that has advantages over standard coherence measures in terms of linking electrophysiological dynamics to trial-varying behavior and experimental variables. After replicating previous response conflict findings using trial-averaged data, we extend these findings using single trial analytic methods to provide novel evidence for the role of medial frontal-lateral prefrontal theta-band synchronization in conflict-induced response time dynamics, including a role for lateral prefrontal theta-band activity in biasing response times according to perceptual conflict. Given that these methods shed new light on the prefrontal mechanisms of response conflict, they are also likely to be useful for investigating other neurocognitive processes.

Clinical Trials

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Full Text Available ... take part in a clinical trial. When researchers think that a trial's potential risks are greater than ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

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Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

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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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Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are ... earlier than they would be in general medical practice. This is because late-phase trials have large ...

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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

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Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... will be done during the clinical trial and why. Each medical center that does the study uses ...

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Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ...

Thomas Mann's Death in Venice or Plutarch's way towards Eros

OpenAIRE

Gilabert Barberà, Pau

2010-01-01

In Death in Venice Thomas Mann refers explicitly to Plato's Symposium and Phaedrus in order to explain the relationship between Gustav von Aschenbach and Tadzio but he hides that his novel also depends on Plutarch's Eroticus. Why? The aim of this article is precisely to reveal the different reasons for such an attitude. Indeed, Plutarch speaks highly of conjugal love in his Eroticus and this way is not followed by Mann in Death in Venice but, at the same, the German writer finds in this Pluta...

EEG source reconstruction reveals frontal-parietal dynamics of spatial conflict processing.

Science.gov (United States)

Cohen, Michael X; Ridderinkhof, K Richard

2013-01-01

Cognitive control requires the suppression of distracting information in order to focus on task-relevant information. We applied EEG source reconstruction via time-frequency linear constrained minimum variance beamforming to help elucidate the neural mechanisms involved in spatial conflict processing. Human subjects performed a Simon task, in which conflict was induced by incongruence between spatial location and response hand. We found an early (∼200 ms post-stimulus) conflict modulation in stimulus-contralateral parietal gamma (30-50 Hz), followed by a later alpha-band (8-12 Hz) conflict modulation, suggesting an early detection of spatial conflict and inhibition of spatial location processing. Inter-regional connectivity analyses assessed via cross-frequency coupling of theta (4-8 Hz), alpha, and gamma power revealed conflict-induced shifts in cortical network interactions: Congruent trials (relative to incongruent trials) had stronger coupling between frontal theta and stimulus-contrahemifield parietal alpha/gamma power, whereas incongruent trials had increased theta coupling between medial frontal and lateral frontal regions. These findings shed new light into the large-scale network dynamics of spatial conflict processing, and how those networks are shaped by oscillatory interactions.

EEG source reconstruction reveals frontal-parietal dynamics of spatial conflict processing.

Directory of Open Access Journals (Sweden)

Michael X Cohen

Full Text Available Cognitive control requires the suppression of distracting information in order to focus on task-relevant information. We applied EEG source reconstruction via time-frequency linear constrained minimum variance beamforming to help elucidate the neural mechanisms involved in spatial conflict processing. Human subjects performed a Simon task, in which conflict was induced by incongruence between spatial location and response hand. We found an early (∼200 ms post-stimulus conflict modulation in stimulus-contralateral parietal gamma (30-50 Hz, followed by a later alpha-band (8-12 Hz conflict modulation, suggesting an early detection of spatial conflict and inhibition of spatial location processing. Inter-regional connectivity analyses assessed via cross-frequency coupling of theta (4-8 Hz, alpha, and gamma power revealed conflict-induced shifts in cortical network interactions: Congruent trials (relative to incongruent trials had stronger coupling between frontal theta and stimulus-contrahemifield parietal alpha/gamma power, whereas incongruent trials had increased theta coupling between medial frontal and lateral frontal regions. These findings shed new light into the large-scale network dynamics of spatial conflict processing, and how those networks are shaped by oscillatory interactions.

EEG Source Reconstruction Reveals Frontal-Parietal Dynamics of Spatial Conflict Processing

Science.gov (United States)

Cohen, Michael X; Ridderinkhof, K. Richard

2013-01-01

Cognitive control requires the suppression of distracting information in order to focus on task-relevant information. We applied EEG source reconstruction via time-frequency linear constrained minimum variance beamforming to help elucidate the neural mechanisms involved in spatial conflict processing. Human subjects performed a Simon task, in which conflict was induced by incongruence between spatial location and response hand. We found an early (∼200 ms post-stimulus) conflict modulation in stimulus-contralateral parietal gamma (30–50 Hz), followed by a later alpha-band (8–12 Hz) conflict modulation, suggesting an early detection of spatial conflict and inhibition of spatial location processing. Inter-regional connectivity analyses assessed via cross-frequency coupling of theta (4–8 Hz), alpha, and gamma power revealed conflict-induced shifts in cortical network interactions: Congruent trials (relative to incongruent trials) had stronger coupling between frontal theta and stimulus-contrahemifield parietal alpha/gamma power, whereas incongruent trials had increased theta coupling between medial frontal and lateral frontal regions. These findings shed new light into the large-scale network dynamics of spatial conflict processing, and how those networks are shaped by oscillatory interactions. PMID:23451201

How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?

Science.gov (United States)

Sawata, Hiroshi; Tsutani, Kiichiro

2011-06-29

Clinical investigations are important for obtaining evidence to improve medical treatment. Large-scale clinical trials with thousands of participants are particularly important for this purpose in cardiovascular diseases. Conducting large-scale clinical trials entails high research costs. This study sought to investigate global trends in large-scale clinical trials in cardiovascular diseases. We searched for trials using clinicaltrials.gov (URL: http://www.clinicaltrials.gov/) using the key words 'cardio' and 'event' in all fields on 10 April, 2010. We then selected trials with 300 or more participants examining cardiovascular diseases. The search revealed 344 trials that met our criteria. Of 344 trials, 71% were randomized controlled trials, 15% involved more than 10,000 participants, and 59% were funded by industry. In RCTs whose results were disclosed, 55% of industry-funded trials and 25% of non-industry funded trials reported statistically significant superiority over control (p = 0.012, 2-sided Fisher's exact test). Our findings highlighted concerns regarding potential bias related to funding sources, and that researchers should be aware of the importance of trial information disclosures and conflicts of interest. We should keep considering management and training regarding information disclosures and conflicts of interest for researchers. This could lead to better clinical evidence and further improvements in the development of medical treatment worldwide.

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.

Clinical Trials

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Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key ... Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

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Full Text Available ... clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage. You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about ...

El Quijote: nutrición y salud

Directory of Open Access Journals (Sweden)

Mª Begoña Carretero Gómez

2006-01-01

Full Text Available Hemos trabajado el tema basado en la nutrición con los alumnos de tercero de la ESO. Para ello se ha desarrollado la siguiente experiencia tomando como referencia la obra del Quijote. Se han utilizado diferentes fragmentos de dicha obra en los cuales se hace referencia a diferentes platos castellano-manchegos. Se recopilaron recetas correspondientes a éstos y otros platos para, posteriormente, realizar un estudio nutricional de los mismos. De la misma manera los alumnos elaboraron diferentes menús utilizando dichos platos, procurando siempre mantener el equilibrio nutricional. Durante el desarrollo de la actividad se ha procurado un enfoque interdisciplinar relacionando el tema principalmente con las áreas de ciencias sociales, educación física, matemáticas y lengua. Finalmente se han cocinado algunas de estas recetas.

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

Directory of Open Access Journals (Sweden)

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

Clinical Trials

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Full Text Available ... need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in ... Maryland, runs clinical trials. Many other clinical trials take place in medical centers and ... trial can have many benefits. For example, you may gain access to new treatments before ...

Duct-to-mucosa versus dunking techniques of pancreaticojejunostomy after pancreaticoduodenectomy: Do we need more trials? A systematic review and meta-analysis with trial sequential analysis.

Science.gov (United States)

Kilambi, Ragini; Singh, Anand Narayan

2018-03-25

Pancreaticojejunostomy (PJ is the most widely used reconstruction technique after pancreaticoduodenectomy. Despite several randomized trials, the ideal technique of pancreaticojejunostomy remains debatable. We planned a meta-analysis of randomized trials comparing the two most common techniques of PJ (duct-to-mucosa and dunking) to identify the best available evidence in the current literature. We searched the Pubmed/Medline, Web of science, Science citation index, Google scholar and Cochrane Central Register of Controlled Trials electronic databases till October 2017 for all English language randomized trials comparing the two approaches. Statistical analysis was performed using Review Manager (RevMan), Version 5.3. Copenhagen: The Nordic Cochrane Center, The Cochrane Collaboration, 2014 and results were expressed as odds ratio for dichotomous and mean difference for continuous variables. P-value ≤ 0.05 was considered significant. Trial sequential analysis was performed using TSA version 0.9.5.5 (Copenhagen: The Copenhagen Trial Unit, Center for Clinical Intervention Research, 2016). A total of 8 trials were included, with a total of 1043 patients (DTM: 518; Dunking: 525). There was no significant difference between the two groups in terms of overall as well as clinically relevant POPF rate. Similarly, both groups were comparable for the secondary outcomes. Trial sequential analysis revealed that the required information size had been crossed without achieving a clinically significant difference for overall POPF; and though the required information size had not been achieved for CR-POPF, the current data has already crossed the futility line for CR-POPF with a 10% risk difference, 80% power and 5% α error. This meta-analysis found no significant difference between the two techniques in terms of overall and CR-POPF rates. Further, the existing evidence is sufficient to conclude lack of difference and further trials are unlikely to result in any change in the

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

Improving The Prototyping Process In Department Of Defense Acquisition

Science.gov (United States)

2014-06-01

assessing program feasibility is to objectively and rationally determine the strengths and weakness of a technology. This functional requirement also...prototypes created for the purpose of maturing technology will not be ready for fielding and cannot be deployed ( Plato 1995). Second, there is a risk...pressure to reduce cost and schedule estimates (Weinberg 1991; Plato 1995). The first few iterations of a prototype typically result in immediate high

Determinants of Conflict in the Philippines

Science.gov (United States)

2012-06-01

1965), 13. 137 Tedd Gurr, Why Men Rebel (1965), 13. 138 Jonathan Wolff, " Karl Marx ," The Stanford Encyclopedia of Philosophy (Spring 2011 Edition...490961276. Wolff, Jonathan. “ Karl Marx .” The Stanford Encyclopedia of Philosophy. Spring 2011 Edition (n.d.). http://plato.stanford.edu/archives...accessed March 10, 2011, http://plato.stanford.edu/archives/spr2011/entries/ marx /. 139 Tedd Gurr, Why Men Rebel, (Princeton: Princeton University

How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?

Directory of Open Access Journals (Sweden)

Tsutani Kiichiro

2011-06-01

Full Text Available Abstract Background Clinical investigations are important for obtaining evidence to improve medical treatment. Large-scale clinical trials with thousands of participants are particularly important for this purpose in cardiovascular diseases. Conducting large-scale clinical trials entails high research costs. This study sought to investigate global trends in large-scale clinical trials in cardiovascular diseases. Findings We searched for trials using clinicaltrials.gov (URL: http://www.clinicaltrials.gov/ using the key words 'cardio' and 'event' in all fields on 10 April, 2010. We then selected trials with 300 or more participants examining cardiovascular diseases. The search revealed 344 trials that met our criteria. Of 344 trials, 71% were randomized controlled trials, 15% involved more than 10,000 participants, and 59% were funded by industry. In RCTs whose results were disclosed, 55% of industry-funded trials and 25% of non-industry funded trials reported statistically significant superiority over control (p = 0.012, 2-sided Fisher's exact test. Conclusions Our findings highlighted concerns regarding potential bias related to funding sources, and that researchers should be aware of the importance of trial information disclosures and conflicts of interest. We should keep considering management and training regarding information disclosures and conflicts of interest for researchers. This could lead to better clinical evidence and further improvements in the development of medical treatment worldwide.

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.

Adverse event reporting in cancer clinical trial publications.

Science.gov (United States)

Sivendran, Shanthi; Latif, Asma; McBride, Russell B; Stensland, Kristian D; Wisnivesky, Juan; Haines, Lindsay; Oh, William K; Galsky, Matthew D

2014-01-10

Reporting adverse events is a critical element of a clinical trial publication. In 2003, the Consolidated Standards of Reporting Trials (CONSORT) group generated recommendations regarding the appropriate reporting of adverse events. The degree to which these recommendations are followed in oncology publications has not been comprehensively evaluated. A review of citations from PubMed, Medline, and Embase published between Jan 1, 2009 and December 31, 2011, identified eligible randomized, controlled phase III trials in metastatic solid malignancies. Publications were assessed for 14 adverse event-reporting elements derived from the CONSORT harms extension statement; a completeness score (range, 0 to 14) was calculated by adding the number of elements reported. Linear regression analysis identified which publication characteristics associated with reporting completeness. A total of 175 publications, with data for 96,125 patients, were included in the analysis. The median completeness score was eight (range, three to 12). Most publications (96%) reported only adverse events occurring above a threshold rate or severity, 37% did not specify the criteria used to select which adverse events were reported, and 88% grouped together adverse events of varying severity. Regression analysis revealed that trials without a stated funding source and with an earlier year of publication had significantly lower completeness scores. Reporting of adverse events in oncology publications of randomized trials is suboptimal and characterized by substantial selectivity and heterogeneity. The development of oncology-specific standards for adverse event reporting should be established to ensure consistency and provide critical information required for medical decision-making.

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.

Thomas Aquinas on the Soul: Old problems, New Solutions. Guiding Premises for a Thomistic Synthesis

Directory of Open Access Journals (Sweden)

Yevgeniy Shilov

2012-12-01

Full Text Available This article examines two main approaches to the doctrine of the soul: that of Plato and that of Aristotle. Each of these approaches had its own development and its own interpretations. Plato and his school was more important during the Middle Ages. Through the neo-platonic philosophers it reached Saint Augustine and became a part of the western cultural and religious heritage until finally it was taken up by member of the Franciscan order - Roger Bacon and Bonaventure. But this paradigm could not solve a host of problems connected with the soul and many of them remained unresolved. The end of the twelfth century brought the growth of the universities and the teaching of Aristotle - a new paradigm - transmitted by the Arabic philosophers which was rediscovered by the West. Two commentators on Aristotle - Averroes and Avicenna -were the most important for the West, especially since Avicenna exerted a great influence on Albert the Great. But both Plato and Aristotle, when taken separately, proved to be quite useless in resolving certain problems. But Thomas Aquinas was able to splice the Gordian knot concealing a solution to the problem of the soul. By combining the psychology of Plato with the metaphysics of Aristotle, Thomas succeeded in creating a new concept of the human person. The author of this article has tried to explain the difficulties which faced Thomas and the way in which Thomas was able to resolve a problem which had troubled philosophy through the ages - the problem of reconciling Plato with Aristotle and finding a way to make their conflicting philosophies agree with each other

Clinical Trials

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Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...

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Full Text Available ... Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance ...

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Full Text Available ... more information about eligibility criteria, go to "How Do Clinical Trials Work?" Some trials enroll people who ... for adults. For more information, go to "How Do Clinical Trials Protect Participants?" For more information about ...

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Full Text Available ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

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Full Text Available ... clinical trials are vital to the process of improving medical care. Many people volunteer because they want ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

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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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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... from a study at any time, for any reason. Also, during the trial, you have the right ...

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Full Text Available ... you agree to take part in the trial. Talk with your doctor about specific trials you're ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

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Full Text Available ... any clinical trial before you agree to take part in the trial. Talk with your doctor about specific trials you're interested in. For a list of questions to ask your doctor and the ...

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Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

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Full Text Available ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ... stop a trial, or part of a trial, early if the strategy or treatment is having harmful ...

Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

Science.gov (United States)

Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros

2009-01-01

A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.

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, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

Prevention of Contrast-Induced AKI: A Review of Published Trials and the Design of the Prevention of Serious Adverse Events following Angiography (PRESERVE) Trial

Science.gov (United States)

Gallagher, Martin; Kaufman, James; Cass, Alan; Parikh, Chirag R.; Chertow, Glenn M.; Shunk, Kendrick A.; McCullough, Peter A.; Fine, Michael J.; Mor, Maria K.; Lew, Robert A.; Huang, Grant D.; Conner, Todd A.; Brophy, Mary T.; Lee, Joanne; Soliva, Susan; Palevsky, Paul M.

2013-01-01

Summary Contrast-induced AKI (CI-AKI) is a common condition associated with serious, adverse outcomes. CI-AKI may be preventable because its risk factors are well characterized and the timing of renal insult is commonly known in advance. Intravenous (IV) fluids and N-acetylcysteine (NAC) are two of the most widely studied preventive measures for CI-AKI. Despite a multitude of clinical trials and meta-analyses, the most effective type of IV fluid (sodium bicarbonate versus sodium chloride) and the benefit of NAC remain unclear. Careful review of published trials of these interventions reveals design limitations that contributed to their inconclusive findings. Such design limitations include the enrollment of small numbers of patients, increasing the risk for type I and type II statistical errors; the use of surrogate primary endpoints defined by small increments in serum creatinine, which are associated with, but not necessarily causally related to serious, adverse, patient-centered outcomes; and the inclusion of low-risk patients with intact baseline kidney function, yielding low event rates and reduced generalizability to a higher-risk population. The Prevention of Serious Adverse Events following Angiography (PRESERVE) trial is a randomized, double-blind, multicenter trial that will enroll 8680 high-risk patients undergoing coronary or noncoronary angiography to compare the effectiveness of IV isotonic sodium bicarbonate versus IV isotonic sodium chloride and oral NAC versus oral placebo for the prevention of serious, adverse outcomes associated with CI-AKI. This article discusses key methodological issues of past trials investigating IV fluids and NAC and how they informed the design of the PRESERVE trial. PMID:23660180

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Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...

Real Leadership and the U.S. Army: Overcoming a Failure of Imagination to Conduct Adaptive Work

Science.gov (United States)

2011-12-01

Picasso In the Republic, Plato presents an allegory to de- scribe man’s resistance to imagining beyond the boundaries of his experiences...Courage to Create, London, UK: Norton, 1975), p. 60. 2. Plato , The Republic, New York: Oxford University Press, 1945, pp. 232-233. 3. Martin E. Dempsey...enemy will be networked and not always rational . The host nation and the enemy will be news-media savvy and will use information operations to

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

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Full Text Available ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Clinical trials for children have the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ...

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Full Text Available ... give permission for their child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Find a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

Public awareness and perception of clinical trials: Quantitative study in Pune

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Veena D Joshi

2013-01-01

Full Text Available Context: Studies have reported that clinical research has experienced tremendous growth during past few decades with many multinational pharmaceutical companies recruiting millions of Indians in clinical trials (CTs. However, there is hardly any literature that talks about the participants, their knowledge, and awareness of CTs. It is important that the general public is aware about CTs so that they can take their own informed decision to participate in CTs. Aim: To assess public awareness, perceptions, and attitudes toward CTs and their views on various methods to create awareness about CTs. Materials and Methods: Cross sectional survey was conducted with 200 non trial participants (NTPs and 40 trial participants (TPs. Results: TPs were significantly (P < 0.0001 older than NTPs. More than 80% of both TPs and NTPs mentioned participation in CT helps advance medical science and strongly felt that there is a need to create awareness about CTs. Nearly 70% of TPs could not remember the phase of the trial while 20% did not know which type of trial they had participated . The main reason for participation in the trial was physician′s advice. About 80% of both TPs and NTPs felt that participation in CT will increase with free medications and advice from friends/relatives who had good experience with trial. Conclusion: Results of this pilot study revealed need to create CT awareness among the general public. However, considering ethno-cultural, regional, and literacy-level differences throughout the country, a nationwide study would be appropriate to provide reliable results about awareness of CTs among Indians.

Managing clinical trials

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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.

Accelerating stem cell trials for Alzheimer's disease.

Science.gov (United States)

Hunsberger, Joshua G; Rao, Mahendra; Kurtzberg, Joanne; Bulte, Jeff W M; Atala, Anthony; LaFerla, Frank M; Greely, Henry T; Sawa, Akira; Gandy, Sam; Schneider, Lon S; Doraiswamy, P Murali

2016-02-01

At present, no effective cure or prophylaxis exists for Alzheimer's disease. Symptomatic treatments are modestly effective and offer only temporary benefit. Advances in induced pluripotent stem cell (iPSC) technology have the potential to enable development of so-called disease-in-a-dish personalised models to study disease mechanisms and reveal new therapeutic approaches, and large panels of iPSCs enable rapid screening of potential drug candidates. Different cell types can also be produced for therapeutic use. In 2015, the US Food and Drug Administration granted investigational new drug approval for the first phase 2A clinical trial of ischaemia-tolerant mesenchymal stem cells to treat Alzheimer's disease in the USA. Similar trials are either underway or being planned in Europe and Asia. Although safety and ethical concerns remain, we call for the acceleration of human stem cell-based translational research into the causes and potential treatments of Alzheimer's disease. Copyright © 2016 Elsevier Ltd. All rights reserved.

Raising Public Awareness of Clinical Trials: Development of Messages for a National Health Communication Campaign.

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Massett, Holly A; Dilts, David M; Bailey, Robert; Berktold, Jennifer; Ledsky, Rebecca; Atkinson, Nancy L; Mishkin, Grace; Denicoff, Andrea; Padberg, Rose Mary; Allen, Marin P; Silver, Karen; Carrington, Kelli; Johnson, Lenora E

2017-05-01

Clinical trials are essential for developing new and effective treatments and improving patient quality of life; however, many trials cannot answer their primary research questions because they fall short of their recruitment goals. This article reports the results of formative research conducted in two populations, the public and primary care physicians, to identify messages that may raise awareness and increase interest in clinical trials and be used in a national communication campaign. Results suggested that participants were primarily motivated to participate in clinical trials out of a self-interest to help themselves first. Messages illustrated that current treatments were tested via clinical trials, helped normalize trials as routine practices, and reduced concerns over trying something new first. Participants wanted messages that portray trials as state-of-the-art choices that offer some hope, show people like themselves, and are described in a clear, concise manner with actionable steps for them to take. The study revealed some differences in message salience, with healthy audiences exhibiting lower levels of interest. Our results suggest that targeted messages are needed, and that communication with primary health-care providers is an important and necessary component in raising patient awareness of the importance of clinical trials.

Clinical Trials

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Full Text Available ... more screening tests to see which test produces the best results. Some companies and groups sponsor clinical trials that test the ... and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

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Full Text Available ... resources to the strategies and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking part in a clinical trial is different ...

Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial.

Science.gov (United States)

Tanaka, Atsushi; Shimabukuro, Michio; Okada, Yosuke; Taguchi, Isao; Yamaoka-Tojo, Minako; Tomiyama, Hirofumi; Teragawa, Hiroki; Sugiyama, Seigo; Yoshida, Hisako; Sato, Yasunori; Kawaguchi, Atsushi; Ikehara, Yumi; Machii, Noritaka; Maruhashi, Tatsuya; Shima, Kosuke R; Takamura, Toshinari; Matsuzawa, Yasushi; Kimura, Kazuo; Sakuma, Masashi; Oyama, Jun-Ichi; Inoue, Teruo; Higashi, Yukihito; Ueda, Shinichiro; Node, Koichi

2017-04-12

Type 2 diabetes mellitus (T2DM) is characterized by systemic metabolic abnormalities and the development of micro- and macrovascular complications, resulting in a shortened life expectancy. A recent cardiovascular (CV) safety trial, the EMPA-REG OUTCOME trial, showed that empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, markedly reduced CV death and all-cause mortality and hospitalization for heart failure in patients with T2DM and established CV disease (CVD). SGLT2 inhibitors are known to not only decrease plasma glucose levels, but also favorably modulate a wide range of metabolic and hemodynamic disorders related to CV pathways. Although some experimental studies revealed a beneficial effect of SGLT2 inhibitors on atherosclerosis, there is a paucity of clinical data showing that they can slow the progression of atherosclerosis in patients with T2DM. Therefore, the EMBLEM trial was designed to investigate whether empagliflozin treatment can improve endothelial function, which plays a pivotal role in the pathogenesis of atherosclerosis, in patients with T2DM and established CVD. The EMBLEM trial is an ongoing, prospective, multicenter, placebo-controlled double-blind randomized, investigator-initiated clinical trial in Japan. A total of 110 participants with T2DM (HbA1c range 6.0-10.0%) and with established CVD will be randomized (1:1) to receive either empagliflozin 10 mg once daily or a placebo. The primary endpoint of the trial is change in the reactive hyperemia (RH)-peripheral arterial tonometry-derived RH index at 24 weeks from baseline. For comparison of treatment effects between the treatment groups, the baseline-adjusted means and their 95% confidence intervals will be estimated by analysis of covariance adjusted for the following allocation factors: HbA1c (EMBLEM is the first trial to assess the effect of empagliflozin on endothelial function in patients with T2DM and established CVD. Additionally, mechanisms associating

ROLE OF ANCIENT HERITAGE IN FORMING CHRISTIAN WORLD PICTURE

Directory of Open Access Journals (Sweden)

Vadim Vadimovich Kortunov

2014-11-01

Full Text Available The article compares the views of Plato and Aristotle in terms of their relation to the problem of rationality. In fact, Plato and Aristotle have absolutely opposite positions on the question of the essence of philosophy, its subject, its methods; they call for a completely incompatible with each other interpretations of the basis of the life. For Plato, true being is spiritual, transcendental that does not fit into any rational-logical framework. For Aristotle true being is subject-sensual, quite rationally knowable within the boundaries of logical thinking. For Plato, the subject-sensual - is illusory "shadow" of the spirit; for Aristotle absolute spirit is a theoretical assumption, assumption forced, as a kind of methodological assumption to justify the reality of the subject-sensual, "flesh" world. Aristotle most clearly formulated the idea of the rational-logical totality, as a whole it is quite popular for the ancient metaphysics, with which the natural philosophers, and Eleatics, and sophists were largely agreed. Plato, "Opened" transcendence, outlined ways to super-rational, and in many respects to the irrational and mystical understanding of the philosophical problems. And in this sense, as well as Orphics and the Pythagoreans, he left some opposition to the rational-logical tradition of ancient Greece. Plato argued that the truth - it is itself a spiritual reality, which is originally opened to man: it is beyond controversy, representing the true being. From this he concluded that the forms of life and forms of logical thinking differ from each other. For Aristotle, on the contrary, the truth is the correspondence of the forms of thinking to the forms of being; it is not a reality, but it is a reflection of the reality in the structures of human consciousness. And we need to dad that just such interpretation of truth firmly established in Western philosophy and science.These two tendencies, aimed at forming rational and irrational

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

Clinical Trials

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Full Text Available ... about your health or fill out forms about how you feel. Some people will need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in Bethesda, Maryland, runs clinical trials. Many other clinical trials take place ...

Clinical Trials

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Full Text Available ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment options. Together, you can make the ... more about, or taking part in, clinical trials, talk with your doctor. He or she may know about ... clinical trials. NIH Clinical Research Studies ...

Fighting Tomorrows Fire Today: Leveraging Intelligence for Scenario-Based Exercise Design

Science.gov (United States)

2014-03-01

of Martin Fishbein and Icek Ajzenand and the theory of reasoned action.55 The theory states that “behavior is rational and is dependent on the...that may only be conscious of the current practices. The Allegory of Plato’s Cave illustrates this well:112 Plato imagines a cave, in which several...never seen the real objects before, the prisoners believe that the shadows of objects were “real.” Plato suggests that the prisoners would begin a

Cicero's Cosmos: Somnium Scipionis ("The Dream of Scipio")

Science.gov (United States)

Miller, N.

2011-06-01

The Dream of Scipio (b. 185 BCE) is the concluding excerpt of Cicero's dialogue in his De Republica ("On the Republic"), which has survived in the neo-Platonic commentaries on the text by Macrobius in the 4th century CE. A variation of its model Plato's Republic, the dialogue is set in 129 BCE. Parallels exist between Plato's closing with the myth of Er, recounting the structure of the cosmos and ordering of the planets and Cicero's cosmology updated by post-Hellenistic astronomical speculation. The Dream begins with his adoptive grandfather Cornelius Scipio Africanus appearing to his son Scipio in heaven as he looks down on Earth, a distant sphere amidst spheres of the universe. The deceased father presents the conditions of his legacy-to do upon Earth as his ancestors have done: "love justice and wisdom", and be devoted to your country, the highest form of virtue. Gazing on the stars-the Milky Way, home of the departed souls, Scipio realizes the relative insignificance of the Earth compared to the stars (analogy with the Roman Empire, a "pinpoint […] of this small Earth"). Africanus orders Scipio to look at the universe, the nine concentric spheres at the very center. Thus, fixed in place, the Earth does not move. Scipio then hears sounds-the music of the spheres in motion, its basis in mathematics and harmonic proportions. Comparisons between the works of Plato and Cicero are revealing. Both stress the relationship of city and state, and both share concern with justice and moral behavior. Whereas Plato focuses on the journey of the soul in the afterlife, Cicero's purpose is to show how public service, the importance of civic life, is a divinely sanctioned activity: "And remember that the most splendid deeds you can do are those which serve your country". The two major themes are the immortality of the soul and the relationship between human society and the divine order of the universe. Scipio must "contemplate the heavens in order to act rightly on Earth". The

Long-term results of 2 adjuvant trials reveal differences in chemosensitivity and the pattern of metastases between colon cancer and rectal cancer.

Science.gov (United States)

Kornmann, Marko; Staib, Ludger; Wiegel, Thomas; Kron, Martina; Henne-Bruns, Doris; Link, Karl-Heinrich; Formentini, Andrea

2013-03-01

Two identical randomized controlled trials designed to optimize adjuvant treatment of colon cancer (CC) (n =855) and rectal cancer (RC) (n = 796) were performed. Long-term evaluation confirmed that the addition of folinic acid (FA) to 5-fluorouracil (5-FU) improved 7-year overall survival (OS) in CC but not in RC and revealed different patterns of recurrence in patients with CC and those with RC. Our aim was to compare long-term results of adjuvant treatment of colon cancer (CC) and rectal cancer (RC). Adjuvant chemotherapy of CC improved overall survival (OS), whereas that of RC remained at the level achieved by 5-fluorouracil (5-FU). We separately conducted 2 identically designed adjuvant trials in CC and RC. Patients were assigned to adjuvant chemotherapy with 5-FU alone, 5-FU + folinic acid (FA), or 5-FU + interferon-alfa. The first study enrolled patients with stage IIb/III CC, and the second study enrolled patients with stage II/III RC. All patients with RC received postoperative irradiation. Median follow-up for all patients with CC (n = 855) and RC (n = 796) was 4.9 years. The pattern and frequency of recurrence differed significantly, especially lung metastases, which occurred more frequently in RC (12.7%) than in CC (7.3%; P < .001). Seven-year OS rates for 5-FU, 5-FU + FA, and 5-FU + IFN-alfa were 54.1% (95% confidence interval [CI], 46.5-61.0), 66.8% (95% CI, 59.4-73.1), and 56.7% (95% CI, 49.3-63.4) in CC and 50.6% (95% CI, 43.0-57.7), 56.3% (95% CI, 49.4-62.7), and 54.8% (95% CI, 46.7-62.2) in RC, respectively. A subgroup analysis pointed to a reduced local recurrence (LR) rate and an increased OS by the addition of FA in stage II RC (n = 271) but not in stage III RC (n = 525). FA increased 7-year OS by 12.7 percentage points in CC but was not effective in RC. Based on these results and the pattern of metastases, our results suggest that the chemosensitivity of CC and RC may be different. Strategies different from those used in CC may be successful to

Improving agricultural knowledge management: The AgTrials experience [version 1; referees: 2 approved

Directory of Open Access Journals (Sweden)

Glenn Hyman

2017-03-01

Full Text Available Background: Opportunities to use data and information to address challenges in international agricultural research and development are expanding rapidly. The use of agricultural trial and evaluation data has enormous potential to improve crops and management practices. However, for a number of reasons, this potential has yet to be realized. This paper reports on the experience of the AgTrials initiative, an effort to build an online database of agricultural trials applying principles of interoperability and open access. Methods: Our analysis evaluates what worked and what did not work in the development of the AgTrials information resource. We analyzed data on our users and their interaction with the platform. We also surveyed our users to gauge their perceptions of the utility of the online database. Results: The study revealed barriers to participation and impediments to interaction, opportunities for improving agricultural knowledge management and a large potential for the use of trial and evaluation data. Conclusions: Technical and logistical mechanisms for developing interoperable online databases are well advanced.  More effort will be needed to advance organizational and institutional work for these types of databases to realize their potential.

Improving agricultural knowledge management: The AgTrials experience [version 2; referees: 2 approved

Directory of Open Access Journals (Sweden)

Glenn Hyman

2017-10-01

Full Text Available Background: Opportunities to use data and information to address challenges in international agricultural research and development are expanding rapidly. The use of agricultural trial and evaluation data has enormous potential to improve crops and management practices. However, for a number of reasons, this potential has yet to be realized. This paper reports on the experience of the AgTrials initiative, an effort to build an online database of agricultural trials applying principles of interoperability and open access. Methods: Our analysis evaluates what worked and what did not work in the development of the AgTrials information resource. We analyzed data on our users and their interaction with the platform. We also surveyed our users to gauge their perceptions of the utility of the online database. Results: The study revealed barriers to participation and impediments to interaction, opportunities for improving agricultural knowledge management and a large potential for the use of trial and evaluation data. Conclusions: Technical and logistical mechanisms for developing interoperable online databases are well advanced.  More effort will be needed to advance organizational and institutional work for these types of databases to realize their potential.

PRE-TRIAL SUPPORT OF YOUNG OFFENDERS (EFFECTIVENESS OF IMPLEMENTATION IN ARKHANGELSK REGION

Directory of Open Access Journals (Sweden)

Yana Korneeva

2015-09-01

Full Text Available Sophisticated criminal situation with juvenile delinquency in Arkhangelsk region has prompted practitioners to find new ways to counteract. The basis for the acquisition of new knowledge in the field of prevention of juvenile delinquency was the phased introduction of social support for the pre-trial juvenile in conflict with the law. Based on the survey of investigators, investigators, judges and social workers involved in the experiment, the analysis of materials of criminal cases involving young offender’s conclusions about the positive results of the experiment revealed the difficulties and challenges faced by law enforcers. The article provides suggestions for optimizing the procedure of pre-trial support.

Dispositional Optimism and Therapeutic Expectations in Early Phase Oncology Trials

Science.gov (United States)

Jansen, Lynn A.; Mahadevan, Daruka; Appelbaum, Paul S.; Klein, William MP; Weinstein, Neil D.; Mori, Motomi; Daffé, Racky; Sulmasy, Daniel P.

2016-01-01

Purpose Prior research has identified unrealistic optimism as a bias that might impair informed consent among patient-subjects in early phase oncology trials. Optimism, however, is not a unitary construct – it can also be defined as a general disposition, or what is called dispositional optimism. We assessed whether dispositional optimism would be related to high expectations for personal therapeutic benefit reported by patient-subjects in these trials but not to the therapeutic misconception. We also assessed how dispositional optimism related to unrealistic optimism. Methods Patient-subjects completed questionnaires designed to measure expectations for therapeutic benefit, dispositional optimism, unrealistic optimism, and the therapeutic misconception. Results Dispositional optimism was significantly associated with higher expectations for personal therapeutic benefit (Spearman r=0.333, poptimism was weakly associated with unrealistic optimism (Spearman r=0.215, p=0.005). In multivariate analysis, both dispositional optimism (p=0.02) and unrealistic optimism (poptimism (p=.0001), but not dispositional optimism, was independently associated with the therapeutic misconception. Conclusion High expectations for therapeutic benefit among patient-subjects in early phase oncology trials should not be assumed to result from misunderstanding of specific information about the trials. Our data reveal that these expectations are associated with either a dispositionally positive outlook on life or biased expectations about specific aspects of trial participation. Not all manifestations of optimism are the same, and different types of optimism likely have different consequences for informed consent in early phase oncology research. PMID:26882017

On the Statistical Properties of the Lower Main Sequence

International Nuclear Information System (INIS)

Angelou, George C.; Bellinger, Earl P.; Hekker, Saskia; Basu, Sarbani

2017-01-01

Astronomy is in an era where all-sky surveys are mapping the Galaxy. The plethora of photometric, spectroscopic, asteroseismic, and astrometric data allows us to characterize the comprising stars in detail. Here we quantify to what extent precise stellar observations reveal information about the properties of a star, including properties that are unobserved, or even unobservable. We analyze the diagnostic potential of classical and asteroseismic observations for inferring stellar parameters such as age, mass, and radius from evolutionary tracks of solar-like oscillators on the lower main sequence. We perform rank correlation tests in order to determine the capacity of each observable quantity to probe structural components of stars and infer their evolutionary histories. We also analyze the principal components of classic and asteroseismic observables to highlight the degree of redundancy present in the measured quantities and demonstrate the extent to which information of the model parameters can be extracted. We perform multiple regression using combinations of observable quantities in a grid of evolutionary simulations and appraise the predictive utility of each combination in determining the properties of stars. We identify the combinations that are useful and provide limits to where each type of observable quantity can reveal information about a star. We investigate the accuracy with which targets in the upcoming TESS and PLATO missions can be characterized. We demonstrate that the combination of observations from GAIA and PLATO will allow us to tightly constrain stellar masses, ages, and radii with machine learning for the purposes of Galactic and planetary studies.

On the Statistical Properties of the Lower Main Sequence

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Angelou, George C.; Bellinger, Earl P.; Hekker, Saskia [Max-Planck-Institut für Sonnensystemforschung, Justus-von-Liebig-Weg 3, D-37077 Göttingen (Germany); Basu, Sarbani [Department of Astronomy, Yale University, New Haven, CT 06520 (United States)

2017-04-20

Astronomy is in an era where all-sky surveys are mapping the Galaxy. The plethora of photometric, spectroscopic, asteroseismic, and astrometric data allows us to characterize the comprising stars in detail. Here we quantify to what extent precise stellar observations reveal information about the properties of a star, including properties that are unobserved, or even unobservable. We analyze the diagnostic potential of classical and asteroseismic observations for inferring stellar parameters such as age, mass, and radius from evolutionary tracks of solar-like oscillators on the lower main sequence. We perform rank correlation tests in order to determine the capacity of each observable quantity to probe structural components of stars and infer their evolutionary histories. We also analyze the principal components of classic and asteroseismic observables to highlight the degree of redundancy present in the measured quantities and demonstrate the extent to which information of the model parameters can be extracted. We perform multiple regression using combinations of observable quantities in a grid of evolutionary simulations and appraise the predictive utility of each combination in determining the properties of stars. We identify the combinations that are useful and provide limits to where each type of observable quantity can reveal information about a star. We investigate the accuracy with which targets in the upcoming TESS and PLATO missions can be characterized. We demonstrate that the combination of observations from GAIA and PLATO will allow us to tightly constrain stellar masses, ages, and radii with machine learning for the purposes of Galactic and planetary studies.

Comparison of deck- and trial-based approaches to advantageous decision making on the Iowa Gambling Task.

Science.gov (United States)

Visagan, Ravindran; Xiang, Ally; Lamar, Melissa

2012-06-01

We compared the original deck-based model of advantageous decision making assessed with the Iowa Gambling Task (IGT) with a trial-based approach across behavioral and physiological outcomes in 33 younger adults (15 men, 18 women; 22.2 ± 3.7 years of age). One administration of the IGT with simultaneous measurement of skin conductance responses (SCRs) was performed and the two methods applied: (a) the original approach of subtracting disadvantageous picks of Decks A and B from advantageous picks of Decks C and D and (b) a trial-based approach focused on the financial outcome for each deck leading up to the trial in question. When directly compared, the deck-based approach resulted in a more advantageous behavioral profile than did the trial-based approach. Analysis of SCR data revealed no significant differences between methods for physiological measurements of SCR fluctuations or anticipatory responses to disadvantageous picks. Post hoc investigation of the trial-based method revealed Deck B contributed to both advantageous and disadvantageous decision making for the majority of participants. When divided by blocks of 20, the number of advantageous to disadvantageous choices reversed as the task progressed despite the total number of picks from Deck B remaining high. SCR fluctuations for Deck B, although not significantly different from the other decks, did show a sharp decline after the first block of 20 and remained below levels for Decks C and D toward the end of the task, suggesting that participants may have gained knowledge of the frequency of loss for this deck. (c) 2012 APA, all rights reserved

Philosophein as ergon: Plato’s Socrates in Herodotus’ Solon

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Adriano Machado Ribeiro

2017-12-01

Full Text Available The purpose of this paper is to show how Plato did not have, at a glance, the poet as his main opponent: as Havelock wishes to prove, Plato’s problem is not only a quarrel about orality in poetry against the lettered intellectual. Thus, it is important to notice that in Apology of Socrates, Plato proposes to illustrate the difference between Socrates’ philosophein and the activity of the nominated sophistai, as seen that in The Clouds by Aristophanes the Socratic character is presented as a sophistes. However, we cannot forget that in the Fifth Century the words philosopher and sophist had a similar meaning. The aim of this study is, though, to discuss that in Herodotus, when Croesus and Solon meet, it is possible to differentiate the philosophical from certain sophistical activity and Plato probably used this distinction in certain passages in his work to highlight Solon as a singular wise man apart from the others. Hence, there would be a possible diversity of erga in the investigation in order to gain a knowledge. It would be, thus, less of a distinction between the poet of oral culture and the intellectual philosopher what Plato would aim to do immediately, but above all, through the theoretical knowledge, to justify rationally the most beautiful human actions.

CIÊNCIA E MATEMÁTICA, NA REPÚBLICA, DE PLATÃO

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Hugo Filgueiras de Araújo

2014-01-01

Full Text Available This article aims to analyze how the Republic of the Plato discusses the concepts of math and science, more specifically in books V, VI and VII of this dialogue. Were first raised some preliminary issues considered in relation to the peculiar way in which Plato developed his writing, if the dialogical style that asks a whole care in their reading, but also arose the problem of translations made from Greek to Portuguese that sometimes hinders its understanding. In a second moment was approached understanding of the term science in Greek, making a relationship with mathematics. As a starting point, was taken the assumption that for Plato the math does not fit the classification of science. This research seeks to understand these concepts in the Platonic philosophy, and there is no way to accomplish such a purpose without resorting to the issues that are most relevant in the Platonic philosophy (epistemology and ontology, considering the arguments of Reminiscence and the Theory of Forms. The paper ends by concluding that science is only considered in the Platonic philosophy that we can have knowledge of the reality, and that, according to the philosopher, is the dialectic; getting the math therefore framed within a framework of knowledge that Plato says in the Republic be among the opinion (doxa and science itself (epistême that is the understanding (dianoia.

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

Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

Science.gov (United States)

Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

2008-12-01

Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

Advancing Military Professionalism in Africa

Science.gov (United States)

2014-07-01

professional military. It simultaneously undermines a military’s commitment to protect the country and its citizens. Plato noted some 2,400 years ago...stepping down from his post as Senior Advisor to the President on Defence and Security.42 He procured not only spoiled food rations for the Ugandan... Plato , The Republic, tr. G.M.A. Grube (Hacket, 1992), 417b and 434a-b. 17 “Above the State: The Officers’ Republic in Egypt,” Carnegie Middle East Center

Are Clinical Trial Experiences Utilized?: A Differentiated Model of Medical Sites’ Information Transfer Ability

DEFF Research Database (Denmark)

Smed, Marie; Schultz, Carsten; Getz, Kenneth A.

2015-01-01

The collaboration with medical professionals in pharmaceutical clinical trials facilitates opportunities to gain valuable market information concerning product functionality issues, as well as issues related to market implementation and adoption. However, previous research on trial management lacks......’ information transfer ability, their methods of communicating, are included. The model is studied on a unique dataset of 395 medical site representatives by applying Rasch scale modeling to differentiate the stickiness of the heterogenic information issues. The results reveal that economic measures...... a differentiated perspective on the potential for information transfer from site to producer. An exploration of the variation in stickiness of information, and therefore the complexity of information transfer in clinical trials, is the main aim of this study. To further enrich the model of the dispersed sites...

Understanding noninferiority trials

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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.

Analysis of 100-Year-Old Beer Originated from the Czech Republic.

Science.gov (United States)

Olšovská, Jana; Matoulková, Dagmar; Dušek, Martin; Felsberg, Jürgen; Jelínková, Markéta; Čejka, Pavel; Štěrba, Karel

2017-04-26

Three bottles of different beers were found in 2015 during a reconstruction of the brewery of the Raven Trading s.r.o. company in Záhlinice, Czech Republic. Thanks to good storage conditions, it was possible to analyze their original characteristics. All three bottles contained most probably lager type beer. One beer had sulfuric and fecal off-flavors; it was bright with the original extract of 10.3° Plato. The second beer, with an original extract of 7.6° Plato, was dark and very acidic, resembling Lambic. DNA analysis proved the presence of Dekkera bruxellensis, which corresponded to its chemical profile (total acidity, FAN, ethyl acetate, total esters). The third beer contained traces of carbon dioxide bubbles, was light brown and slightly bitter, with an original extract 10.4° Plato. Because it obviously underwent a natural aging process, sweetness, honey, and fruity off-flavors were detected and transformation products of iso-α-acids were found.

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.

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.

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.

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…

Kant and zeno of elea: historical precedents of the "sceptical method"

Directory of Open Access Journals (Sweden)

Giuseppe Micheli

2014-12-01

Full Text Available For Kant's interpretation of Zeno in KrV A502-507/B530-535, scholars have usually referred to Plato's Phaedrus (261d; in reality the sources Kant uses are, on one hand, Brucker (who depends in turn on the pseudo-Aristotelian De Melisso, Xenophane, et Gorgia, 977 b 2-21, and, on the other, Plato's Parmenides (135e6-136b1 and Proclus' commentary on it, as quoted by Gassendi in a popular textbook he wrote on the history of logic.

Clinical Trials

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Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...

Linking ClinicalTrials.gov and PubMed to track results of interventional human clinical trials.

Directory of Open Access Journals (Sweden)

Vojtech Huser

Full Text Available OBJECTIVE: In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world's largest clinical trial registry. MATERIALS AND METHODS: We considered two trial result artifacts: (1 existence of a trial result journal article that is formally linked to a registered trial or (2 the deposition of a trial's basic summary results within the registry. RESULTS: The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2% had no structured trial-article link present. A total of 2367 trials (26.6% deposited basic summary results within the registry. Of those, 969 trials (10.9% were classified as trials with extended results and 1398 trials (15.7% were classified as trials with only required basic results. The majority of the trials (54.8% had no evidence of results, based on either linked result articles or basic summary results (silent trials, while a minimal number (9.2% report results through both registry deposition and publication. DISCUSSION: Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the "trialome". Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased. CONCLUSION: Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.

A multi-dataset time-reversal approach to clinical trial placebo response and the relationship to natural variability in epilepsy.

Science.gov (United States)

Goldenholz, Daniel M; Strashny, Alex; Cook, Mark; Moss, Robert; Theodore, William H

2017-12-01

Clinical epilepsy drug trials have been measuring increasingly high placebo response rates, up to 40%. This study was designed to examine the relationship between the natural variability in epilepsy, and the placebo response seen in trials. We tested the hypothesis that 'reversing' trial direction, with the baseline period as the treatment observation phase, would reveal effects of natural variability. Clinical trial simulations were run with time running forward and in reverse. Data sources were: SeizureTracker.com (patient reported diaries), a randomized sham-controlled TMS trial, and chronically implanted intracranial EEG electrodes. Outcomes were 50%-responder rates (RR50) and median percentage change (MPC). The RR50 results showed evidence that temporal reversal does not prevent large responder rates across datasets. The MPC results negative in the TMS dataset, and positive in the other two. Typical RR50s of clinical trials can be reproduced using the natural variability of epilepsy as a substrate across multiple datasets. Therefore, the placebo response in epilepsy clinical trials may be attributable almost entirely to this variability, rather than the "placebo effect". Published by Elsevier Ltd.

Clinical Trials

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Full Text Available ... to main content U.S. Department of Health & Human ... of people. Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ...

Clinical Trials

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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 ...

Clinical Trials

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Full Text Available ... well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

Can we identify non-stationary dynamics of trial-to-trial variability?

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Emili Balaguer-Ballester

Full Text Available Identifying sources of the apparent variability in non-stationary scenarios is a fundamental problem in many biological data analysis settings. For instance, neurophysiological responses to the same task often vary from each repetition of the same experiment (trial to the next. The origin and functional role of this observed variability is one of the fundamental questions in neuroscience. The nature of such trial-to-trial dynamics however remains largely elusive to current data analysis approaches. A range of strategies have been proposed in modalities such as electro-encephalography but gaining a fundamental insight into latent sources of trial-to-trial variability in neural recordings is still a major challenge. In this paper, we present a proof-of-concept study to the analysis of trial-to-trial variability dynamics founded on non-autonomous dynamical systems. At this initial stage, we evaluate the capacity of a simple statistic based on the behaviour of trajectories in classification settings, the trajectory coherence, in order to identify trial-to-trial dynamics. First, we derive the conditions leading to observable changes in datasets generated by a compact dynamical system (the Duffing equation. This canonical system plays the role of a ubiquitous model of non-stationary supervised classification problems. Second, we estimate the coherence of class-trajectories in empirically reconstructed space of system states. We show how this analysis can discern variations attributable to non-autonomous deterministic processes from stochastic fluctuations. The analyses are benchmarked using simulated and two different real datasets which have been shown to exhibit attractor dynamics. As an illustrative example, we focused on the analysis of the rat's frontal cortex ensemble dynamics during a decision-making task. Results suggest that, in line with recent hypotheses, rather than internal noise, it is the deterministic trend which most likely underlies

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.

Los indios y los empedrados sotaquireños

Directory of Open Access Journals (Sweden)

Edwin Giovanni Quesada-Cárdenas

2016-09-01

Full Text Available Este artículo de investigación describe la preparación de los platos culinarios tradicionales del municipio de Sotaquirá (Boyacá, que hacen parte de los saberes ancestrales que han prevalecido generacionalmente en los habitantes del municipio; ya que caracterizan la identidad sotaquireña. También se exponen algunos elementos sobre la gestión de la administración municipal (2012-2015 para promover la permanencia y reconocimiento de estos saberes como patrimonio cultural. El contenido del artículo es el resultado de la investigación “Identidad campesina en torno a los oficios tradicionales en el municipio de Sotaquirá (2013-2015”; que tuvo como fin describir las costumbres culturales en torno a los oficios tradicionales, que configuran la identidad campesina de los habitantes del municipio de Sotaquirá. El enfoque metodológico fue cualitativo desde la corriente socio-critica; se usaron la entrevista y la observación participante para reconocer la importancia de los platos que se configuran como aspectos fundamentales de la identidad de los sotaquireños. Se destaca que este trabajo logró generar espacios de reflexión con los entrevistados respecto de los oficios tradicionales culinarios del municipio en torno al reconocimiento del valor de los platos como patrimonio cultural y las particularidades del plato de acuerdo con los contextos familiares.

THE BEAUTY OF THE WORLD IN PLATO’S TIMAEUS

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O’Meara, Dominic

2014-01-01

Full Text Available In the Timaeus Plato describes the world as the ‘most beautiful’ (kallistos, 29a5 of generated things. Perhaps indeed this is the first systematic description of the beauty of the world. It is, at any rate, one of the most influential statements of the theme. The Stoics were deeply convinced by it and later, in the third century A.D., at a time when contempt and hate for the world were propagated by Gnostic movements, Plotinus, interpreting the Timaeus, would write magnificent passages on the beauty and value of the world. But what does Plato mean by the ‘beauty’ of the world? What makes the world beautiful? In this paper these questions are approached first (1 by a brief discussion of the distinction which Plato appears to make in the Timaeus between beauty and the good. In one passage (Tim. 87c ‘measure’ seems to relate to this distinction. It is suitable then (2 to look at a section of another late work of Plato, the Philebus, where the themes of beauty, goodness and measure may be compared in more detail. The theme of measure then takes us back (3 to the Timaeus, in order to examine the role played by measure, in particular mathematical measure, in constituting the beauty of the world. I discuss in detail the way in which mathematical structures make for the beauty of soul and body in the living whole that is the world.

Clinical Trials

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Full Text Available ... Some companies and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

Use of the foil activation method with arbitrary trial functions to determine neutron energy spectra

International Nuclear Information System (INIS)

Kelly, J.G.; Vehar, D.W.

1987-01-01

Neutron Spectra have been measured by the foil activation method in thirteen different environments in and around the Sandia Pulsed Reactor (SPR-III), the White Sands Missile Range FBR, and the Annular Core Research Reactor (ACRR). The unfolded spectra were obtained by using the SANDII code in a manner which was not dependent on the initial trial. This altered technique is, therefore, better suited for the determination of spectra in environments that are difficult to predict by calculation, and it tends to reveal features that may be biased out by the use of standard trial functions

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Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ...

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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... 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 ... needed. For safety purposes, clinical trials start with small groups of patients to find out whether a ... phase I clinical trials test new treatments in small groups of people for safety and side effects. ...

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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... Learn More Connect With Us Contact Us Directly Policies Privacy Policy Freedom of Information Act (FOIA) Accessibility ...

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Court grants courier a jury trial based on fear of AIDS.

Science.gov (United States)

1996-03-08

A medical courier who was exposed to blood from a leaking container will be granted a jury trial in Albuquerque, NM. Courier [name removed] was splashed with blood and became alarmed because she had paper cuts on her hands. Repeated blood tests for HIV and hepatitis B were negative. A Bernallilo County judge initially dismissed [name removed]'s lawsuit when the hospital revealed that there was no HIV present in the splashed liquid. A three-judge panel of the Court of Appeals ruled to allow [name removed] a jury trial because New Mexico law no longer requires a plaintiff to prove that the defendant's actions created actual danger or physical impact. The panel determined that [name removed]'s allegations stated a cause for negligent infliction of emotional distress.

Panorámica de la cocina colombiana

OpenAIRE

Jaime Alzate

2003-01-01

El territorio colombiano, dotado de selvas, cordilleras, valles, mares y ríos, conjugado con las tradiciones culturales propias de cada región, le ha dado a la cocina colombiana variedad y exquisitez. Al recorrer el país encontramos diversidad de platos, ricos en ingredientes naturales y con el sello inconfundible de los pueblos y su arte culinario. Las costas sobre los dos mares hacen uso de su abundancia de mariscos y pescados: la Atlántica, enriqueciendo los platos con tubérculos y carnes ...

Estudio del efecto del procesado e ingredientes funcionales en la textura de purés de patata frescos y congelados

OpenAIRE

Jiménez Sánchez, María José

2015-01-01

En los últimos años el contexto económico, social y cultural ha generado que en los países desarrollados se dedique menos tiempo a la preparación de platos tradicionales. El ritmo de vida incesante en las grandes urbes ha generado un aumento del consumo de platos precocinados y congelados. Simultáneamente, los últimos datos sobre obesidad y enfermedades cardiovasculares han provocado un aumento de la concienciación social por la necesidad de disminuir la ingesta total calórica aumentando...

Clinical Trials

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Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...

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Full Text Available ... Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including ... our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

Clinical Trials

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Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

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Full Text Available ... treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ... are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and ...

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Full Text Available ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...

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Full Text Available ... 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. (When the trial began, HT ...

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Full Text Available ... Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... and advance medical care. They also can help health care decisionmakers direct resources to the strategies and treatments ...

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Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's ...

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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 ... identified earlier than they would be in general medical practice. This is because late-phase trials have large ... supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

Mechanisms Underlying Decision-Making as Revealed by Deep-Brain Stimulation in Patients with Parkinson's Disease.

Science.gov (United States)

Herz, Damian M; Little, Simon; Pedrosa, David J; Tinkhauser, Gerd; Cheeran, Binith; Foltynie, Tom; Bogacz, Rafal; Brown, Peter

2018-04-23

To optimally balance opposing demands of speed and accuracy during decision-making, we must flexibly adapt how much evidence we require before making a choice. Such adjustments in decision thresholds have been linked to the subthalamic nucleus (STN), and therapeutic STN deep-brain stimulation (DBS) has been shown to interfere with this function. Here, we performed continuous as well as closed-loop DBS of the STN while Parkinson's disease patients performed a perceptual decision-making task. Closed-loop STN DBS allowed temporally patterned STN stimulation and simultaneous recordings of STN activity. This revealed that DBS only affected patients' ability to adjust decision thresholds if applied in a specific temporally confined time window during deliberation. Only stimulation in that window diminished the normal slowing of response times that occurred on difficult trials when DBS was turned off. Furthermore, DBS eliminated a relative, time-specific increase in STN beta oscillations and compromised its functional relationship with trial-by-trial adjustments in decision thresholds. Together, these results provide causal evidence that the STN is involved in adjusting decision thresholds in distinct, time-limited processing windows during deliberation. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Cervical spine disease may result in a negative lumbar spinal drainage trial in normal pressure hydrocephalus: case report.

Science.gov (United States)

Komotar, Ricardo J; Zacharia, Brad E; Mocco, J; Kaiser, Michael G; Frucht, Stephen J; McKhann, Guy M

2008-10-01

In this case report, we present a patient with normal pressure hydrocephalus in whom a lumbar drainage trial yielded a false-negative result secondary to cervical spondylosis. An 80-year-old woman presented with classic symptoms of normal pressure hydrocephalus as well as evidence of cervical myelopathy. Magnetic resonance imaging of the brain and spine showed enlarged ventricles and single-level cervical canal narrowing. An initial lumbar drainage trial was performed, which revealed negative results. The patient then underwent cervical decompression and fusion. Despite this procedure, the patient's symptoms continued to worsen. A repeat lumbar drainage trial was performed with positive results. Subsequently, a ventriculoperitoneal shunt was placed, resulting in significant improvement of her symptoms. This case report illustrates how altered cerebrospinal fluid flow dynamics may impact the accuracy of the lumbar spinal drainage trial in patients with normal pressure hydrocephalus.

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Full Text Available ... the clinical trial you take part in, the information gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care. Many people volunteer because ...

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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 ... Sponsors also may stop a trial, or part of a trial, early if the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight ...

The Effectiveness of Music in Pediatric Healthcare: A Systematic Review of Randomized Controlled Trials

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Karline Treurnicht Naylor

2011-01-01

Full Text Available The aim of this study was to systematically review the effectiveness of music on pediatric health-related outcomes. Five electronic databases were searched for randomized controlled/crossover trial designs published between 1984 and 2009. Eligible studies used music as a therapy or intervention, included participants 1 to 18 years, and focused on at least one health-related outcome (with the exclusion of procedural pain. Seventeen studies met the inclusion criteria. Quantitative synthesis was hampered by an inability to aggregate data arising from heterogeneity of interventions, outcomes and measurement tools. Qualitative synthesis revealed significant improvements in one or more health outcomes within four of seven trials involving children with learning and developmental disorders; two of three trials involving children experiencing stressful life events; and four of five trials involving children with acute and/or chronic physical illness. No significant effects were found for two trials involving children with mood disorders and related psychopathology. These findings offer limited qualitative evidence to support the effectiveness of music on health-related outcomes for children and adolescents with clinical diagnoses. Recommendations for establishing a consensus on research priorities and addressing methodological limitations are put forth to support the continued advancement of this popular intervention.

The Effectiveness of Music in Pediatric Healthcare: A Systematic Review of Randomized Controlled Trials

Science.gov (United States)

Treurnicht Naylor, Karline; Kingsnorth, Shauna; Lamont, Andrea; McKeever, Patricia; Macarthur, Colin

2011-01-01

The aim of this study was to systematically review the effectiveness of music on pediatric health-related outcomes. Five electronic databases were searched for randomized controlled/crossover trial designs published between 1984 and 2009. Eligible studies used music as a therapy or intervention, included participants 1 to 18 years, and focused on at least one health-related outcome (with the exclusion of procedural pain). Seventeen studies met the inclusion criteria. Quantitative synthesis was hampered by an inability to aggregate data arising from heterogeneity of interventions, outcomes and measurement tools. Qualitative synthesis revealed significant improvements in one or more health outcomes within four of seven trials involving children with learning and developmental disorders; two of three trials involving children experiencing stressful life events; and four of five trials involving children with acute and/or chronic physical illness. No significant effects were found for two trials involving children with mood disorders and related psychopathology. These findings offer limited qualitative evidence to support the effectiveness of music on health-related outcomes for children and adolescents with clinical diagnoses. Recommendations for establishing a consensus on research priorities and addressing methodological limitations are put forth to support the continued advancement of this popular intervention. PMID:20976017

Hydrotherapy as a recovery strategy after exercise: a pragmatic controlled trial.

Science.gov (United States)

Cuesta-Vargas, Antonio I; Travé-Mesa, Alvaro; Vera-Cabrera, Alberto; Cruz-Terrón, Dario; Castro-Sánchez, Adelaida M; Fernández-de-las-Peñas, Cesar; Arroyo-Morales, Manuel

2013-07-18

Our aim was to evaluate the recovery effects of hydrotherapy after aerobic exercise in cardiovascular, performance and perceived fatigue. A pragmatic controlled repeated measures; single-blind trial was conducted. Thirty-four recreational sportspeople visited a Sport-Centre and were assigned to a Hydrotherapy group (experimental) or rest in a bed (control) after completing a spinning session. Main outcomes measures including blood pressure, heart rate, handgrip strength, vertical jump, self-perceived fatigue, and body temperature were assessed at baseline, immediately post-exercise and post-recovery. The hypothesis of interest was the session*time interaction. The analysis revealed significant session*time interactions for diastolic blood pressure (P=0.031), heart rate (P=0.041), self perceived fatigue (P=0.046), and body temperature (P=0.001); but not for vertical jump (P=0.437), handgrip (P=0.845) or systolic blood pressure (P=0.266). Post-hoc analysis revealed that hydrotherapy resulted in recovered heart rate and diastolic blood pressure similar to baseline values after the spinning session. Further, hydrotherapy resulted in decreased self-perceived fatigue after the spinning session. Our results support that hydrotherapy is an adequate strategy to facilitate cardiovascular recovers and perceived fatigue, but not strength, after spinning exercise. ClinicalTrials.gov Identifier: NCT01765387.

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.

UK Dermatology Clinical Trials Network's STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial.

Science.gov (United States)

Craig, Fiona F; Thomas, Kim S; Mitchell, Eleanor J; Williams, Hywel C; Norrie, John; Mason, James M; Ormerod, Anthony D

2012-04-28

Pyoderma gangrenosum (PG) is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs) relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network's STOP GAP Trial has been designed to address this lack of trial evidence. The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day) to prednisolone (0.75 mg/kg/day). A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers). Secondary outcomes include: (i) time to healing; (ii) global assessment of improvement; (iii) PG inflammation assessment scale score; (iv) self-reported pain; (v) health-related quality of life; (vi) time to recurrence; (vii) treatment failures; (viii) adverse reactions to study medications; and (ix) cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG); measurable ulceration (that is, not pustular PG); and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size, stratified by lesion size, and

Randomized Trial of Anger Control Training for Adolescents with Tourette's Syndrome and Disruptive Behavior

Science.gov (United States)

Sukhdolsky, Denis G.; Vitulano, Lawrence A.; Carroll, Deirdre H.; McGuire, Joseph; Leckman, James F.; Scahill, Lawrence

2009-01-01

A randomized trial to examine the efficacy of anger control training for treating adolescents with Tourette's syndrome and disruptive behavior reveals that those administered with the anger control training showed a decrease in their Disruptive Behavior Rating Scale score by 52 percent as compared with a decrease of 11 percent in the treatment as…

Clinical Trials

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Full Text Available ... other expenses (for example, travel and child care)? Who will be in charge of my care? What will happen after the trial? Taking part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

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.

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

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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.

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 ...

UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum: protocol for a randomised controlled trial

Directory of Open Access Journals (Sweden)

Craig Fiona F

2012-04-01

Full Text Available Abstract Background Pyoderma gangrenosum (PG is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network’s STOP GAP Trial has been designed to address this lack of trial evidence. Methods The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day to prednisolone (0.75 mg/kg/day. A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers. Secondary outcomes include: (i time to healing; (ii global assessment of improvement; (iii PG inflammation assessment scale score; (iv self-reported pain; (v health-related quality of life; (vi time to recurrence; (vii treatment failures; (viii adverse reactions to study medications; and (ix cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG; measurable ulceration (that is, not pustular PG; and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size

Imitating the Myth in the Gorgias

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Efren A. Alverio II

2001-06-01

Full Text Available The advent of logical positivism contributed to the sharp definitional demarcation between what we consider mythical (mythos and what we take to be a true account (logos. This essay attempts to go back to one of the sources of such a supposed distinction. By analyzing the Gorgias, I will show that even Plato did not make such a distinction. In fact, Plato even constructed a theory of justice that made use of myth as its medium. The Platonic Myth in the Gorgias was used as true logos in order to justify Socrates' use of the myth as the paradigm of a life that is philosophical in contrast to that of his accusers who espoused mere sophistry. By using the concept of historia in relation with the concept of mythos, Plato regarded the futuristic afterlife in the myth as a sufficient condition to live a just life. This sufficient condition exemplified by the Myth in the Gorgias is a measuring rod by which we can compare our present system of justice.

Verification of the calculation program for brachytherapy planning system of high dose rate (PLATO); Programa de verificacion del calculo para un sistema de planificacion de braquiterapia de alta tasa de dosis (PLATO)

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Almansa, J.; Alaman, C.; Perez-Alija, J.; Herrero, C.; Real, R. del; Ososrio, J. L.

2011-07-01

In our treatments are performed brachytherapy high dose rate since 2007. The procedures performed include gynecological intracavitary treatment and interstitial. The treatments are performed with a source of Ir-192 activity between 5 and 10 Ci such that small variations in treatment times can cause damage to the patient. In addition the Royal Decree 1566/1998 on Quality Criteria in radiotherapy establishes the need to verify the monitor units or treatment time in radiotherapy and brachytherapy. All this justifies the existence of a redundant system for brachytherapy dose calculation that can reveal any abnormality is present.

"SOCRATICS" AS ADDRESSES OF ISOCRATES’ EPIDEICTIC SPEECHES (Against the Sophists, Encomium of Helen, Busiris

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Anna Usacheva

2012-06-01

Full Text Available This article analyses the three epideictic orations of Isocrates which are in themselves a precious testimony of the quality of intellectual life at the close of the fourth century before Christ. To this period belong also the Socratics who are generally seen as an important link between Socrates and Plato. The author of this article proposes a more productive approach to the study of Antisthenes, Euclid of Megara and other so-called Socratics, revealing them not as independent thinkers but rather as adherents of the sophistic school and also as teachers, thereby, including them among those who took part in the educative activity of their time

Clinical Trials

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Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, talk with your doctor. He or she may know about studies going on in your area. You can visit the following website to learn more about ...

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Full Text Available ... Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... phase II clinical trials. The risk of side effects might be even greater for ... treatments. Health insurance and health care providers don't always ...

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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 ... as clinical trials for adults. For more information, go to "How Do Clinical ...

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.

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Full Text Available ... trial found that one of the combinations worked much better than the other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI ...

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Full Text Available ... products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ... cancer also increased. As a result, the U.S. Food and Drug Administration now recommends never using HT ... Clinical Trials Work If you take ...

SINGLE VERSUS MULTIPLE TRIAL VECTORS IN CLASSICAL DIFFERENTIAL EVOLUTION FOR OPTIMIZING THE QUANTIZATION TABLE IN JPEG BASELINE ALGORITHM

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B Vinoth Kumar

2017-07-01

Full Text Available Quantization Table is responsible for compression / quality trade-off in baseline Joint Photographic Experts Group (JPEG algorithm and therefore it is viewed as an optimization problem. In the literature, it has been found that Classical Differential Evolution (CDE is a promising algorithm to generate the optimal quantization table. However, the searching capability of CDE could be limited due to generation of single trial vector in an iteration which in turn reduces the convergence speed. This paper studies the performance of CDE by employing multiple trial vectors in a single iteration. An extensive performance analysis has been made between CDE and CDE with multiple trial vectors in terms of Optimization process, accuracy, convergence speed and reliability. The analysis report reveals that CDE with multiple trial vectors improves the convergence speed of CDE and the same is confirmed using a statistical hypothesis test (t-test.

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.

Attitudes of Patients in Developing Countries Toward Participating in Clinical Trials: A Survey of Saudi Patients Attending Primary Health Care Services

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Lateefa O. Al-Dakhil

2016-07-01

Full Text Available Objectives: Clinical trials are experimental projects that include patients as subjects. A number of benefits are directly associated with clinical trials. Healthcare processes and outcomes can be improved with the help of clinical trials. This study aimed to assess the attitudes and beliefs of patients about their contribution to and enrolment in clinical trials. Methods: A cross-sectional study design was used for data collection and analysis. A questionnaire was developed with six categories to derive effective outcomes. Results: Of the 2000 participants approached to take part in the study, 1081 agreed. The majority of the study population was female, well educated, and unaware of clinical trials. Only 324 subjects (30.0% had previously agreed to participate in a clinical trial. The majority (87.1% were motivated to participate in clinical trials due to religious aspects. However, fear of any risk was the principal reason (79.8% that reduced their motivation to participate. Conclusions: The results of this study revealed that patients in Saudi Arabia have a low awareness and are less willing to participate in clinical trials. Different motivational factors and awareness programs can be used to increase patient participation in the future.

[Art-chance and art-experience in classical Greece].

Science.gov (United States)

Ban, Deokjin

2011-06-30

In Classical Greece, works defining the nature of art appeared in the various disciplines like medicine, rhetoric, dietetics, architecture and painting. Hippocratic authors tried to show that an art of medicine existed indeed. They contrasted the concept of art with that of chance, not experience that Plato and Aristotle distinguished from art. In fact there are similarities and discrepancies between Hippocratic epistemology and Platoic epistemology. Hippocratic authors maintained that the products of chance were not captured by art. They distinguished the domain of art charactered by explanatory knowledge and prediction from the domain of chance ruled by the unexplained and the unforeseeable. They minimized the role of luck and believed the role of art. Hippocratic authors thought that professional ability contained both knowledge and experience. In Hippocratic corpus, experience is a synonym of competence and usually has a positive meaning. But Plato gave empirical knowledge the disdainful sense and decided a ranking between two types of knowledge. Both Hippocratic authors and Plato held that a genuine art had connection with explanatory knowledge of the nature of its subject matter. A common theme that goes through arguments about art-chance and art-chance is the connection between art and nature. Hippocratic authors and Plato regarded art as a highly systematic process. Art provides us with general and explanatory knowledge of human nature. Art and nature is a mutual relationship. The systematic understanding of nature helps us gain the exactness of art and an exact art helps us understand nature well.

Oferta y composición nutricional de ensaladas en patios de comida de centros comerciales de Lima Metropolitana, 2014

Directory of Open Access Journals (Sweden)

Marifé Bustamante-García

Full Text Available Objetivos. Evaluar la oferta y composición nutricional de las ensaladas ofrecidas como plato principal en los patios de comida de los centros comerciales de Lima, Perú. Materiales y métodos. Se revisó las cartas de comida de todas las franquicias presentes en los patios de comida de los once centro comerciales de Lima, luego se evaluó la composición nutricional de las ensaladas ofertadas como plato principal calculando su contenido calórico, proteico, carbohidratos, grasas, colesterol, fibra y sodio, y la adecuación de ingesta para una cena (30% de una dieta de 2000 kcal. Resultados. Las ensaladas como plato principal representaron el 4,7% de la oferta, solo 7/17 franquicias ofrecían al menos una ensalada. El costo promedio de las ensaladas fue superior a los otros platos ($5,3 vs 4,7; p<0,001. El contenido calórico promedio fue de 329 kcal y de 2,7 g de fibra; con relación a una cena, se encontró un alto porcentaje de adecuación proteica (172,9%, de colesterol (121,0%, y bajo para calorías (54,8%, carbohidratos (23,1% y fibra (36,4%. Conclusiones. Las ensaladas que se ofertan en patios de centros comerciales de Lima son escasas y más costosas, presentan poco aporte de fibra y altos contenidos de colesterol. Se deben revisar estrategias para mejorar la accesibilidad de ensaladas de calidad en escenarios donde solo ofertan comidas rápidas

Clinical Trials

Medline Plus

Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative ... safe a treatment is or how well it works. Children (aged 18 and younger) get ... legal consent for their child to take part in a clinical trial. When ...

Clinical Trials

Medline Plus

Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... clinical trials are vital to the process of improving medical care. Many people ... participants, it may not work for you. A new treatment may have side ...

Getting educated: e-learning resources in the design and execution of surgical trials.

Science.gov (United States)

Bains, Simrit

2009-01-01

An evidence-based approach to research, which includes important aspects such as critical appraisal, is essential for the effective conduct of clinical trials. Researchers who are interested in educating themselves about its principles in order to incorporate them into their trials face challenges when attempting to acquire this information from traditional learning sources. E-learning resources offer an intriguing possibility of overcoming the challenges posed by traditional learning, and show promise as a way to expand accessibility to quality education about evidence-based principles. An assessment of existing e-learning resources reveals positive educational avenues for researchers, although significant flaws exist. The Global EducatorTM by Global Research Solutions addresses many of these flaws and is an e-learning resource that combines convenience with comprehensiveness.

[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.

The limitations of erudition

Directory of Open Access Journals (Sweden)

Alfredo Serrai

2016-05-01

Full Text Available The aim of the Scholarship Erudition is the fact-finding, and it is to be made by the analysis of documentation. The choice of the facts to be analyzed, however, is subjective and could lead to wrong conclusions. A good example is given by the codex Cam. B. Armadio 2.I of the Classense Library in Ravenna. Inside the codex there is a note by Santi Muratori, the librarian of Classense. The note says the book is to throw away. An analysis of the codex reveals that it is a collection of dissertations and commentaries with quotations from the Fathers of the Church, from Plato and Plotinus, and sometimes the poems of Dante. Probably, the book was for aloud reading during meals of the Camaldolese monks and it reveals a remarkable intellectual liveliness of the monastic community. The codex reveals itself as a good tool for a better knowledge of the Camaldolese’s community, despite of the negative rating by Santi Muratori.

Number in Plato’s Philebus

Directory of Open Access Journals (Sweden)

Shetnikov, Andrey

2009-06-01

Full Text Available The paper concerns the concept of number (arithmos, important for dialectical method of later Plato. It becomes clear that the arithmos in Plato’s dialectics should be understood as a concrete operation, a sort of tekhne, such as counting, enumeration, compilation of a comprehensive and systematic list, etc., rather then the theoretical number of abstract arithmetic. The author analyses a series of grammatical, musical and rhetorical examples, supplied by Plato in the Philebus and other dialogues, and traces the usage of arithmos and similar words in the earlier tradition, particularly, in Homer, Hesiod, the classical tragedy, and Herodotus.

Platón, Aristóteles y la narrativa histórica

Directory of Open Access Journals (Sweden)

Javier Picón Casas

2013-09-01

Full Text Available One of the most showy questions about the works of Plato and Aristotle rests on them silence brings over of the history. They read and criticized physicists, philosophers, mathematicians, biologists, poets, rhetorical, political, etc. Nevertheless, their appointments about the historians of that moment would fit in a sheet of paper. In this brief article we try to offer an explanation about such an omission. Likewise, we are useful to offer a reason of the Menexenus and to contribute a confirmation of the reasons that L. Edelstein led to questioning the genuineness of seventh and eighth letters attributed to Plato.

Similitudes entre as filosofias de Rousseau e Platão

Directory of Open Access Journals (Sweden)

Evaldo Becker

2011-06-01

Full Text Available This article deals with some similitudes that may be perceived between the works of Jean-Jacques Rousseau and those of Plato. We intend to examine mainly the existent resemblances concerning eloquence and the power of discourse, as much as they have political actions as their ends. We aim at demonstrating that both authors attribute both positive and negative traits to discourse and eloquence. In order to achieve these goals, we shall use mainly the works Essay on the origin of languages and Discourse on the origin of inequality, by Rousseau, and Phaedrus and Gorgias, by Plato.

De tumba a útero

Directory of Open Access Journals (Sweden)

Amalia González Suárez

2015-12-01

Full Text Available In this paper we rehearsed dialogue between two chronologically distant contexts: Plato and the present time. The issue to confront is the difference between the sexes in terms of reproduction. Plato considered irrelevant the difference in the dialogue Republic and then became one of the centers of their legislation, in a real matter of state. Currently, the increasing use of surrogacy, which makes pregnancy in a process that can be dispensed by contracting with another woman, it demands a reflection on the political significance that we attach to this practice and thus the legislative framework in which we frame it.

Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

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Sivaramakrishnan, Gowri; Sridharan, Kannan

2016-06-01

Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be

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...

Trial-to-Trial Carryover in Auditory Short-Term Memory

Science.gov (United States)

Visscher, Kristina M.; Kahana, Michael J.; Sekuler, Robert

2009-01-01

Using a short-term recognition memory task, the authors evaluated the carryover across trials of 2 types of auditory information: the characteristics of individual study sounds (item information) and the relationships between the study sounds (study set homogeneity). On each trial, subjects heard 2 successive broadband study sounds and then…

Guided Web-Based Cognitive Behavior Therapy for Perfectionism: Results From Two Different Randomized Controlled Trials.

Science.gov (United States)

Rozental, Alexander; Shafran, Roz; Wade, Tracey D; Kothari, Radha; Egan, Sarah J; Ekberg, Linda; Wiss, Maria; Carlbring, Per; Andersson, Gerhard

2018-04-26

Perfectionism can become a debilitating condition that may negatively affect functioning in multiple areas, including mental health. Prior research has indicated that internet-based cognitive behavioral therapy can be beneficial, but few studies have included follow-up data. The objective of this study was to explore the outcomes at follow-up of internet-based cognitive behavioral therapy with guided self-help, delivered as 2 separate randomized controlled trials conducted in Sweden and the United Kingdom. In total, 120 participants randomly assigned to internet-based cognitive behavioral therapy were included in both intention-to-treat and completer analyses: 78 in the Swedish trial and 62 in the UK trial. The primary outcome measure was the Frost Multidimensional Perfectionism Scale, Concern over Mistakes subscale (FMPS CM). Secondary outcome measures varied between the trials and consisted of the Clinical Perfectionism Questionnaire (CPQ; both trials), the 9-item Patient Health Questionnaire (PHQ-9; Swedish trial), the 7-item Generalized Anxiety Disorder scale (GAD-7; Swedish trial), and the 21-item Depression Anxiety Stress Scale (DASS-21; UK trial). Follow-up occurred after 6 months for the UK trial and after 12 months for the Swedish trial. Analysis of covariance revealed a significant difference between pretreatment and follow-up in both studies. Intention-to-treat within-group Cohen d effect sizes were 1.21 (Swedish trial; 95% CI 0.86-1.54) and 1.24 (UK trial; 95% CI 0.85-1.62) for the FMPS CM. Furthermore, 29 (59%; Swedish trial) and 15 (43%; UK trial) of the participants met the criteria for recovery on the FMPS CM. Improvements were also significant for the CPQ, with effect sizes of 1.32 (Swedish trial; 95% CI 0.97-1.66) and 1.49 (UK trial; 95% CI 1.09-1.88); the PHQ-9, effect size 0.60 (95% CI 0.28-0.92); the GAD-7, effect size 0.67 (95% CI 0.34-0.99); and the DASS-21, effect size 0.50 (95% CI 0.13-0.85). The results are promising for the use of

Verification of the calculation program for brachytherapy planning system of high dose rate (PLATO)

International Nuclear Information System (INIS)

Almansa, J.; Alaman, C.; Perez-Alija, J.; Herrero, C.; Real, R. del; Ososrio, J. L.

2011-01-01

In our treatments are performed brachytherapy high dose rate since 2007. The procedures performed include gynecological intracavitary treatment and interstitial. The treatments are performed with a source of Ir-192 activity between 5 and 10 Ci such that small variations in treatment times can cause damage to the patient. In addition the Royal Decree 1566/1998 on Quality Criteria in radiotherapy establishes the need to verify the monitor units or treatment time in radiotherapy and brachytherapy. All this justifies the existence of a redundant system for brachytherapy dose calculation that can reveal any abnormality is present.

Predicting hypothetical willingness to participate (WTP) in a future phase III HIV vaccine trial among high-risk adolescents.

Science.gov (United States)

Giocos, Georgina; Kagee, Ashraf; Swartz, Leslie

2008-11-01

The present study sought to determine whether the Theory of Planned Behaviour predicted stated hypothetical willingness to participate (WTP) in future Phase III HIV vaccine trials among South African adolescents. Hierarchical logistic regression analyses showed that The Theory of Planned Behaviour (TPB) significantly predicted WTP. Of all the predictors, Subjective norms significantly predicted WTP (OR = 1.19, 95% C.I. = 1.06-1.34). A stepwise logistic regression analysis revealed that Subjective Norms (OR = 1.19, 95% C.I. = 1.07-1.34) and Attitude towards participation in an HIV vaccine trial (OR = 1.32, 95% C.I. = 1.00-1.74) were significant predictors of WTP. The addition of Knowledge of HIV vaccines and HIV vaccine trials, Perceived self-risk of HIV infection, Health-promoting behaviours and Attitudes towards HIV/AIDS yielded non-significant results. These findings provide support for the Theory of Reasoned Action (TRA) and suggest that psychosocial factors may play an important role in WTP in Phase III HIV vaccine trials among adolescents.

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.

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

Intraspinal neural stem cell transplantation in amyotrophic lateral sclerosis: phase 1 trial outcomes.

Science.gov (United States)

Feldman, Eva L; Boulis, Nicholas M; Hur, Junguk; Johe, Karl; Rutkove, Seward B; Federici, Thais; Polak, Meraida; Bordeau, Jane; Sakowski, Stacey A; Glass, Jonathan D

2014-03-01

The US Food and Drug Administration-approved trial, "A Phase 1, Open-Label, First-in-Human, Feasibility and Safety Study of Human Spinal Cord-Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis, Protocol Number: NS2008-1," is complete. Our overall objective was to assess the safety and feasibility of stem cell transplantation into lumbar and/or cervical spinal cord regions in amyotrophic lateral sclerosis (ALS) subjects. Preliminary results have been reported on the initial trial cohort of 12 ALS subjects. Here, we describe the safety and functional outcome monitoring results for the final trial cohort, consisting of 6 ALS subjects receiving 5 unilateral cervical intraspinal neural stem cell injections. Three of these subjects previously received 10 total bilateral lumbar injections as part of the earlier trial cohort. All injections utilized a novel spinal-mounted stabilization and injection device to deliver 100,000 neural stem cells per injection, for a dosing range up to 1.5 million cells. Subject assessments included detailed pre- and postsurgical neurological outcome measures. The cervical injection procedure was well tolerated and disease progression did not accelerate in any subject, verifying the safety and feasibility of cervical and dual-targeting approaches. Analyses on outcome data revealed preliminary insight into potential windows of stem cell biological activity and identified clinical assessment measures that closely correlate with ALS Functional Rating Scale-Revised scores, a standard assessment for ALS clinical trials. This is the first report of cervical and dual-targeted intraspinal transplantation of neural stem cells in ALS subjects. This approach is feasible and well-tolerated, supporting future trial phases examining therapeutic dosing and efficacy. © 2014 Child Neurology Society/American Neurological Association.

Intervention on whole grain with healthy balanced diet to manage childhood obesity (GReat-Child™trial): study protocol for a quasi-experimental trial.

Science.gov (United States)

Koo, H C; Poh, B K; Ruzita, Abd Talib

2016-01-01

The rapid increase in childhood obesity is a serious public health problem, and has led to the development of many interventions. However, no intervention has emphasized whole grains as a strategy to manage childhood obesity. Therefore, this article describes the protocol of a 12-week multi-component, family-based intervention on whole grain, using a healthy balanced diet for managing childhood obesity. The GReat-Child trial utilize a quasi-experimental method in which two schools in Kuala Lumpur are assigned to intervention and control groups. The eligibility criteria are overweight/obese children, aged 9 through 11 years, who has no serious co-morbidities. The children who report consuming whole-grain foods in their 3-day diet-recall during the screening will be excluded. The study sample is characterized by anthropometric measurements (weight, height, percentage of body fat and waist circumference), whole grain and nutrient intakes (3-day 24-h diet recalls), and their knowledge, attitudes and practices towards whole grain. The 12-week intervention is comprised of three components addressing behaviour, personal and environmental factors, based on social cognitive theory: (1) individual diet counselling for the parents; (2) six 30-min nutrition education classes and (3) school delivery of whole-grain foods; The control school does not receive any interventions, however, for ethical purposes, a health talk is conducted after the entire GReat-Child Trial is completed. The GReat-Child trial represents a novel approach to examining the effectiveness of the intervention of whole grain in a healthy balanced diet on managing childhood obesity. We anticipate that this trial will reveal not only whether whole grain intervention will be effective in managing childhood obesity, but also provide greater insights into the acceptance of whole grain among Malaysian children.

Reward-prospect interacts with trial-by-trial preparation for potential distraction.

Science.gov (United States)

Marini, Francesco; van den Berg, Berry; Woldorff, Marty G

2015-02-01

When attending for impending visual stimuli, cognitive systems prepare to identify relevant information while ignoring irrelevant, potentially distracting input. Recent work (Marini et al., 2013) showed that a supramodal distracter-filtering mechanism is invoked in blocked designs involving expectation of possible distracter stimuli, although this entails a cost ( distraction-filtering cost ) on speeded performance when distracters are expected but not presented. Here we used an arrow-flanker task to study whether an analogous cost, potentially reflecting the recruitment of a specific distraction-filtering mechanism, occurs dynamically when potential distraction is cued trial-to-trial ( cued distracter-expectation cost ). In order to promote the maximal utilization of cue information by participants, in some experimental conditions the cue also signaled the possibility of earning a monetary reward for fast and accurate performance. This design also allowed us to investigate the interplay between anticipation for distracters and anticipation of reward, which is known to engender attentional preparation. Only in reward contexts did participants show a cued distracter-expectation cost, which was larger with higher reward prospect and when anticipation for both distracters and reward were manipulated trial-to-trial. Thus, these results indicate that reward prospect interacts with the distracter expectation during trial-by-trial preparatory processes for potential distraction. These findings highlight how reward guides cue-driven attentional preparation.

Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

Directory of Open Access Journals (Sweden)

Paul P Christopher

Full Text Available Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials.This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50, and willingness to participate in the clinical trial.154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female; 74 (48.1% had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004 in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017. Willingness to participate in the hypothetical trial was not significantly different (p = 0.603 between intervention (52.1%, 95% CI [40.2% to 62.4%] and control (56.3%, 95% CI [45.3% to 66.6%] groups.An enhanced educational intervention augmenting

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.

Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative.

Science.gov (United States)

Huang, Grant D; Bull, Jonca; Johnston McKee, Kelly; Mahon, Elizabeth; Harper, Beth; Roberts, Jamie N

2018-03-01

Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

Science.gov (United States)

Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

2016-03-22

To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.

USE OF DIFFUSION-WEIGHTED MAGNETIC RESONANCE IMAGING FOR REVEALING HYPOXIC-ISCHEMIC BRAIN LESIONS IN NEONATES

Directory of Open Access Journals (Sweden)

E. V. Shimchenko

2014-01-01

Full Text Available The article presents advantages of use of diffusion-weighted magnetic resonance imaging (DW MRI for revealing hypoxic-ischemic brain lesions in neonates. The trial included 97 neonates with perinatal brain lesion who had been undergoing treatment at a resuscitation department or neonatal pathology department in the first month of life. The article shows high information value of diffusion-weighted images (DWI for diagnostics of hypoxic-ischemic lesions in comparison with regular standard modes. In the event of no structural brain lesions of neonates, pronounced increase in signal characteristics revealed by DWI indicated considerable pathophysiological alterations. Subsequently, children developed structural alterations in the form of cystic encephalomalacia with expansion of cerebrospinal fluid spaces manifested with pronounced neurological deficit. DW MRI has been offered as a method of prognosticating further neurological development of children on early stages. 

The Impacts of Inclusion in Clinical Trials on Outcomes among Patients with Metastatic Breast Cancer (MBC.

Directory of Open Access Journals (Sweden)

Ji Yun Lee

Full Text Available Metastatic breast cancer (MBC remains a devastating and incurable disease. Over the past decade, the implementation of clinical trials both with and without molecular targeted therapeutics has impacted the daily clinical treatment of patients with MBC. In this study, we determine whether including MBC patients in clinical trials affects clinical outcomes.We retrospectively reviewed data for a total of 863 patients diagnosed with initial or recurrent (after receiving adjuvant systemic treatments following surgery metastatic disease between January 2000 and December 2013. Data were obtained from the breast cancer database of Samsung Medical Center.Among the 806 patients selected for inclusion, 188 (23% had participated in clinical trials. A total of 185 clinical trials were conducted from 2000 to 2014. When compared with earlier periods (n = 10 for 2000-2004, clinical trial enrollment significantly increased over time (n = 103 for 2005-2009, P = 0.024; n = 110 for 2010-2014, P = 0.046. Multivariate analyses revealed that biologic subtype, distant recurrence free interval (DRFI, and clinical trial enrollment were independent predictors of overall survival. Patients who participated in clinical trials showed improved survival, with a hazard ratio of 0.75 (95% CI, 0.59-0.95, which was associated with a 25% reduction in the risk of death. However, subgroup analysis showed that this improved survival benefit was not maintained in patients with triple negative breast cancer (TNBC.Although not conclusive, we could speculate that there were differences in the use of newer agents or regimens over time, and these differences appear to be associated with improved survival.

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.

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.

An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

Science.gov (United States)

Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen

2013-11-01

To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

International Nuclear Information System (INIS)

Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M.; Lössl, Kristina

2016-01-01

To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users

From Controlled Trial to Community Adoption: The Multisite Translational Community Trial

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Murimi, Mary; Gonzalez, Anjelica; Njike, Valentine; Green, Lawrence W.

2011-01-01

Methods for translating the findings of controlled trials, such as the Diabetes Prevention Program, into real-world community application have not been clearly defined. A standardized research methodology for making and evaluating such a transition is needed. We introduce the multisite translational community trial (mTCT) as the research analog to the multisite randomized controlled trial. The mTCT is adapted to incorporate the principles and practices of community-based participatory research and the increased relevance and generalizability gained from diverse community settings. The mTCT is a tool designed to bridge the gap between what a clinical trial demonstrates can work in principle and what is needed to make it workable and effective in real-world settings. Its utility could be put to the test, in particular with practice-based research networks such as the Prevention Research Centers. PMID:21680935

Analysis of classical time-trial performance and technique-specific physiological determinants in elite female cross-country skiers

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Øyvind Sandbakk

2016-08-01

Full Text Available The present study investigated the contribution of performance on uphill, flat, and downhill sections to overall performance in an international 10-km classical time-trial in elite female cross-country skiers, as well as the relationships between performance on snow and laboratory-measured physiological variables in the double poling (DP and diagonal (DIA techniques. Ten elite female cross-country skiers were continuously measured by a global positioning system device during an international 10-km cross-country skiing time-trial in the classical technique. One month prior to the race, all skiers performed a 5-min submaximal and 3-min self-paced performance test while roller skiing on a treadmill, both in the DP and DIA techniques. The time spent on uphill (r=0.98 and flat (r=0.91 sections of the race correlated most strongly with the overall 10-km performance (both p<0.05. Approximately 56% of the racing time was spent uphill, and stepwise multiple regression revealed that uphill time explained 95.5% of the variance in overall performance (p<0.001. Distance covered during the 3-min roller-skiing test and body-mass normalized peak oxygen uptake (VO2peak in both techniques showed the strongest correlations with overall time-trial performance (r=0.66-0.78, with DP capacity tending to have greatest impact on the flat and DIA capacity on uphill terrain (all p<0.05. Our present findings reveal that the time spent uphill most strongly determine classical time-trial performance, and that the major portion of the performance differences among elite female cross-country skiers can be explained by variations in technique-specific aerobic power.

Effect of race/ethnicity on participation in HIV vaccine trials and comparison to other trials of biomedical prevention.

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Dhalla, Shayesta; Poole, Gary

2014-01-01

Racial/ethnic minorities are underrepresented in actual HIV vaccine trials in North America, and willingness to participate (WTP) and retention in an HIV vaccine trial may differ from that in Whites. In this review, the authors identified HIV vaccine preparedness studies (VPS) in North America in high-risk populations that examined the relationship between race/ethnicity and WTP in a preventive phase 3 HIV vaccine trial, and the relationship to retention. Studies were categorized by risk group, and comparison group (Whites vs. non-Whites). Other types of trials of biomedical prevention were also identified, and WTP and retention rates were compared and contrasted to actual HIV vaccine trials. In the studies identified, WTP in a hypothetical trial HIV vaccine trial did not differ by race/ethnicity. In contrast, actual HIV vaccine trials, an HIV acquisition trial, and a phase 2B preexposure prophylaxis (PrEP) trial have enrolled a large percentage of White men. Human papilloma virus (HPV) privately-funded trials have also enrolled a large number of Whites, due to convenience sampling. Retention in the HIV acquisition trial was lower in African-Americans compared with Whites. Strategies to increase WTP and enhanced retention (ER) strategies may help in recruiting and retaining minority participants in actual HIV vaccine trials and other trials of biomedical prevention.

Publication and non-publication of drug trial results: a 10-year cohort of trials in Norwegian general practice.

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Brænd, Anja Maria; Straand, Jørund; Jakobsen, Rune Bruhn; Klovning, Atle

2016-04-11

Previously, we identified a 10-year cohort of protocols from applications to the Norwegian Medicines Agency 1998-2007, consisting of 196 drug trials in general practice. The aim of this study was to examine whether trial results were published and whether trial funding and conflicts of interest were reported. Cohort study of trials with systematic searches for published results. Clinical drug trials in Norwegian general practice. We performed systematic literature searches of MEDLINE, Embase and CENTRAL to identify publications originating from each trial using characteristics such as test drug, comparator and patient groups as search terms. When no publication was identified, we contacted trial sponsors for information regarding trial completion and reference to any publications. We determined the frequency of publication of trial results and trial characteristics associated with publication of results. Of the 196 trials, 5 were never started. Of the remaining 191 trials, 71% had results published in a journal, 11% had results publicly available elsewhere and 18% of trials had no results available. Publication was more common among trials with an active comparator drug (χ(2) test, p=0.040), with a larger number of patients (total sample size≥median, p=0.010) and with a longer trial period (duration≥median, p=0.025). Trial funding was reported in 85% of publications and increased over time, as did reporting of conflicts of interest among authors. Among the 134 main journal articles from the trials, 60% presented statistically significant results for the investigational drug, and the conclusion of the article was favourable towards the test drug in 78% of papers. We did not identify any journal publication of results for 29% of the general practice drug trials. Trials with an active comparator, larger and longer trials were more likely to be published. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

Science.gov (United States)

2013-01-01

Background Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. PMID:23433341

Clinical trial optimization: Monte Carlo simulation Markov model for planning clinical trials recruitment.

Science.gov (United States)

Abbas, Ismail; Rovira, Joan; Casanovas, Josep

2007-05-01

The patient recruitment process of clinical trials is an essential element which needs to be designed properly. In this paper we describe different simulation models under continuous and discrete time assumptions for the design of recruitment in clinical trials. The results of hypothetical examples of clinical trial recruitments are presented. The recruitment time is calculated and the number of recruited patients is quantified for a given time and probability of recruitment. The expected delay and the effective recruitment durations are estimated using both continuous and discrete time modeling. The proposed type of Monte Carlo simulation Markov models will enable optimization of the recruitment process and the estimation and the calibration of its parameters to aid the proposed clinical trials. A continuous time simulation may minimize the duration of the recruitment and, consequently, the total duration of the trial.

Methodology series module 4: Clinical trials

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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.

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

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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

Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma

International Nuclear Information System (INIS)

Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei; Lee, Anne W.M.; Vermorken, Jan B.; Wee, Joseph; O'Sullivan, Brian; Eisbruch, Avraham; Lin, Jin-Ching; Mai, Hai-Qiang; Zhang, Li; Guo, Ying; Lin, Ai-Hua; Sun, Ying

2017-01-01

Purpose: To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality. Methods and Materials: Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events. Results: We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately. Conclusions: Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required.

Reporting Quality of Randomized, Controlled Trials Evaluating Combined Chemoradiotherapy in Nasopharyngeal Carcinoma

Energy Technology Data Exchange (ETDEWEB)

Chen, Yu-Pei; Chen, Lei; Li, Wen-Fei [Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Lee, Anne W.M. [Department of Clinical Oncology, The University of Hong Kong-Shenzhen Hospital, Shenzhen (China); Vermorken, Jan B. [Department of Medical Oncology, Antwerp University Hospital, Edegem (Belgium); Wee, Joseph [Department of Radiation Oncology, National Cancer Centre Singapore (Singapore); O' Sullivan, Brian [Department of Radiation Oncology, University of Toronto, Ontario Cancer Institute, University Health Network, Toronto, Ontario (Canada); Eisbruch, Avraham [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Lin, Jin-Ching [Department of Radiation Oncology, Taichung Veterans General Hospital, Taichung, Taiwan (China); Mai, Hai-Qiang [Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Zhang, Li [Department of Medical Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Guo, Ying [Clinical Trials Centre, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); Lin, Ai-Hua [Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou (China); Sun, Ying [Department of Radiation Oncology, Sun Yat-sen University Cancer Centre, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre of Cancer Medicine, Guangzhou (China); and others

2017-05-01

Purpose: To comprehensively assess the reporting quality of randomized, controlled trials (RCTs) in nasopharyngeal carcinoma (NPC), and to identify significant predictors of quality. Methods and Materials: Two investigators searched MEDLINE and EMBASE for RCTs published between January 1988 and December 2015 that assessed the effect of combined chemoradiotherapy for NPC. The overall quality of each report was assessed using a 28-point overall quality score (OQS) based on the 2010 Consolidated Standards of Reporting Trials (CONSORT) statement. To provide baseline data for further evaluation, we also investigated the reporting quality of certain important issues in detail, including key methodologic items (allocation concealment, blinding, intention-to-treat principle), endpoints, follow-up, subgroup analyses, and adverse events. Results: We retrieved 24 relevant RCTs including 6591 patients. Median 2010 OQS was 15.5 (range, 10-24). Half of the items in the 2010 OQS were poorly reported in at least 40% of trials. Multivariable regression models revealed that publication after 2010 and high impact factor were significant predictors of improved 2010 OQS. Additionally, many issues that we consider significant were not reported adequately. Conclusions: Despite publication of the CONSORT statement more than a decade ago, overall reporting quality for RCTs in NPC was unsatisfactory. Additionally, substantial selectivity and heterogeneity exists in reporting of certain crucial issues. This survey provides the first prompt for NPC trial investigators to improve reporting quality according to the CONSORT statement; increased scrutiny and diligence by editors and peer reviewers is also required.

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.

The Trial of Napoleon: A Case Study for Using Mock Trials.

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MacKay, Charles

2000-01-01

Describes a course entitled "The Trial of Napoleon Bonaparte" that focuses on a fictitious mock trial of Napoleon Bonaparte to answer the question: did Napoleon pervert or preserve the gain of the French Revolution? Discusses the strengths and weaknesses of the course. (CMK)

Experimental burn plot trial in the Kruger National Park: history, experimental design and suggestions for data analysis

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R. Biggs

2003-12-01

Full Text Available The experimental burn plot (EBP trial initiated in 1954 is one of few ongoing long-termfire ecology research projects in Africa. The trial aims to assess the impacts of differentfire regimes in the Kruger National Park. Recent studies on the EBPs have raised questions as to the experimental design of the trial, and the appropriate model specificationwhen analysing data. Archival documentation reveals that the original design was modified on several occasions, related to changes in the park's fire policy. These modifications include the addition of extra plots, subdivision of plots and changes in treatmentsover time, and have resulted in a design which is only partially randomised. The representativity of the trial plots has been questioned on account of their relatively small size,the concentration of herbivores on especially the frequently burnt plots, and soil variation between plots. It is suggested that these factors be included as covariates inexplanatory models or that certain plots be excluded from data analysis based on resultsof independent studies of these factors. Suggestions are provided for the specificationof the experimental design when analysing data using Analysis of Variance. It is concluded that there is no practical alternative to treating the trial as a fully randomisedcomplete block design.

Antibiosis resistance in national uniform wheat yield trials against rhopalosiphum padi (L.)

International Nuclear Information System (INIS)

Akhtar, N.; Ashfaque, M.; Gillani, W.A.; Ata-ul-Mohsin; Tahfeen, A.; Begum, I.

2010-01-01

The germplasm of National Uniform Wheat Yield Trials (Normal) (2003-04) were screened against Rhopalosiphum padi L., bird cherry oat aphid at National Agricultural Research Centre, Islamabad. Twenty National Uniform Wheat Yield Trials (NUWYT) , Normal and 12 (NUWYT) rain fed varieties/ lines were evaluated for seedling bulk test to know the resistant, moderately resistant and susceptible wheat varieties/ lines. These results revealed that varieties Diamond and Margalla-99 and lines V-99022, 99B2278 and 7-03 were partially resistant, two lines V-00125 and SD-66 were susceptible and three varieties and ten lines were moderately resistant in seedling bulk test. For antibiosis studies, 10 varieties/ lines out of 20 were selected to know the effect of host plants on the fecundity of R. padi. Two varieties Wafaq-2007 and Diamond were the least preferred for fecundity and one line VOO125 was highly preferred for fecundity. (author)

Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials

Science.gov (United States)

Whitehead, Amy; Pottrill, Edward; Julious, Steven A; Walters, Stephen J

2018-01-01

Background/aims: External pilot trials are recommended for testing the feasibility of main or confirmatory trials. However, there is little evidence that progress in external pilot trials actually predicts randomisation and attrition rates in the main trial. To assess the use of external pilot trials in trial design, we compared randomisation and attrition rates in publicly funded randomised controlled trials with rates in their pilots. Methods: Randomised controlled trials for which there was an external pilot trial were identified from reports published between 2004 and 2013 in the Health Technology Assessment Journal. Data were extracted from published papers, protocols and reports. Bland–Altman plots and descriptive statistics were used to investigate the agreement of randomisation and attrition rates between the full and external pilot trials. Results: Of 561 reports, 41 were randomised controlled trials with pilot trials and 16 met criteria for a pilot trial with sufficient data. Mean attrition and randomisation rates were 21.1% and 50.4%, respectively, in the pilot trials and 16.8% and 65.2% in the main. There was minimal bias in the pilot trial when predicting the main trial attrition and randomisation rate. However, the variation was large: the mean difference in the attrition rate between the pilot and main trial was −4.4% with limits of agreement of −37.1% to 28.2%. Limits of agreement for randomisation rates were −47.8% to 77.5%. Conclusion: Results from external pilot trials to estimate randomisation and attrition rates should be used with caution as comparison of the difference in the rates between pilots and their associated full trial demonstrates high variability. We suggest using internal pilot trials wherever appropriate. PMID:29361833

Avoiding Systematic Errors in Isometric Squat-Related Studies without Pre-Familiarization by Using Sufficient Numbers of Trials

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Pekünlü Ekim

2014-10-01

Full Text Available There is no scientific evidence in the literature indicating that maximal isometric strength measures can be assessed within 3 trials. We questioned whether the results of isometric squat-related studies in which maximal isometric squat strength (MISS testing was performed using limited numbers of trials without pre-familiarization might have included systematic errors, especially those resulting from acute learning effects. Forty resistance-trained male participants performed 8 isometric squat trials without pre-familiarization. The highest measures in the first “n” trials (3 ≤ n ≤ 8 of these 8 squats were regarded as MISS obtained using 6 different MISS test methods featuring different numbers of trials (The Best of n Trials Method [BnT]. When B3T and B8T were paired with other methods, high reliability was found between the paired methods in terms of intraclass correlation coefficients (0.93-0.98 and coefficients of variation (3.4-7.0%. The Wilcoxon’s signed rank test indicated that MISS obtained using B3T and B8T were lower (p < 0.001 and higher (p < 0.001, respectively, than those obtained using other methods. The Bland- Altman method revealed a lack of agreement between any of the paired methods. Simulation studies illustrated that increasing the number of trials to 9-10 using a relatively large sample size (i.e., ≥ 24 could be an effective means of obtaining the actual MISS values of the participants. The common use of a limited number of trials in MISS tests without pre-familiarization appears to have no solid scientific base. Our findings suggest that the number of trials should be increased in commonly used MISS tests to avoid learning effect-related systematic errors

Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries.

Science.gov (United States)

Choi, Sheung-Nyoung; Lee, Ji-Hyun; Song, In-Kyung; Kim, Eun-Hee; Kim, Jin-Tae; Kim, Hee-Soo

2017-12-01

The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. We searched for pediatric clinical studies (participants South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.

General practice-based clinical trials in Germany - a problem analysis

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Hummers-Pradier Eva

2012-11-01

Full Text Available Abstract Background In Germany, clinical trials and comparative effectiveness studies in primary care are still very rare, while their usefulness has been recognised in many other countries. A network of researchers from German academic general practice has explored the reasons for this discrepancy. Methods Based on a comprehensive literature review and expert group discussions, problem analyses as well as structural and procedural prerequisites for a better implementation of clinical trials in German primary care are presented. Results In Germany, basic biomedical science and technology is more reputed than clinical or health services research. Clinical trials are funded by industry or a single national programme, which is highly competitive, specialist-dominated, exclusive of pilot studies, and usually favours innovation rather than comparative effectiveness studies. Academic general practice is still not fully implemented, and existing departments are small. Most general practitioners (GPs work in a market-based, competitive setting of small private practices, with a high case load. They have no protected time or funding for research, and mostly no research training or experience. Good Clinical Practice (GCP training is compulsory for participation in clinical trials. The group defined three work packages to be addressed regarding clinical trials in German general practice: (1 problem analysis, and definition of (2 structural prerequisites and (3 procedural prerequisites. Structural prerequisites comprise specific support facilities for general practice-based research networks that could provide practices with a point of contact. Procedural prerequisites consist, for example, of a summary of specific relevant key measures, for example on a web platform. The platform should contain standard operating procedures (SOPs, templates, checklists and other supporting materials for researchers. Conclusion All in all, our problem analyses revealed that

Subgroup Analysis of Trials Is Rarely Easy (SATIRE: a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trials

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Malaga German

2009-11-01

Full Text Available Abstract Background Subgroup analyses in randomized trials examine whether effects of interventions differ between subgroups of study populations according to characteristics of patients or interventions. However, findings from subgroup analyses may be misleading, potentially resulting in suboptimal clinical and health decision making. Few studies have investigated the reporting and conduct of subgroup analyses and a number of important questions remain unanswered. The objectives of this study are: 1 to describe the reporting of subgroup analyses and claims of subgroup effects in randomized controlled trials, 2 to assess study characteristics associated with reporting of subgroup analyses and with claims of subgroup effects, and 3 to examine the analysis, and interpretation of subgroup effects for each study's primary outcome. Methods We will conduct a systematic review of 464 randomized controlled human trials published in 2007 in the 118 Core Clinical Journals defined by the National Library of Medicine. We will randomly select journal articles, stratified in a 1:1 ratio by higher impact versus lower impact journals. According to 2007 ISI total citations, we consider the New England Journal of Medicine, JAMA, Lancet, Annals of Internal Medicine, and BMJ as higher impact journals. Teams of two reviewers will independently screen full texts of reports for eligibility, and abstract data, using standardized, pilot-tested extraction forms. We will conduct univariable and multivariable logistic regression analyses to examine the association of pre-specified study characteristics with reporting of subgroup analyses and with claims of subgroup effects for the primary and any other outcomes. Discussion A clear understanding of subgroup analyses, as currently conducted and reported in published randomized controlled trials, will reveal both strengths and weaknesses of this practice. Our findings will contribute to a set of recommendations to optimize

Credentialing for participation in clinical trials

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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.

Credentialing for participation in clinical trials

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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.

Radial growth and percent of latewood in Scots pine provenance trials in Western and Central Siberia

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S. R. Kuzmin

2016-12-01

Full Text Available Percent of latewood of Boguchany and Suzun Scots pine climatypes has been studied in two provenance trials (place of origin and trial place. For Boguchany climatype the place of origin is south taiga of Central Siberia (Krasnoyarsk Krai, the place of trial is forest-steppe zone of Western Siberia (Novosibirsk Oblast and vice versa for Suzun climatype – forest-steppe zone of Western Siberia is the place of origin, south taiga is the place of trial. Comparison of annual average values of latewood percent of Boguchany climatype in south taiga and forest-steppe revealed the same numbers – 19 %. Annual variability of this trait in south taiga is distinctly lower and equal to 17 %, in forest-steppe – 35 %. Average annual values of latewood percent of Suzun climatype in the place of origin and trial place are close (20 and 21 %. Variability of this trait for Suzun climatype is higher than for Boguchany and equal to 23 % in south taiga and 42 % in forest-steppe. Climatic conditions in southern taiga in Central Siberia in comparison with forest-steppe in Western Siberia make differences between climatypes stronger. Differences between climatypes are expressed in different age of maximal increments of diameter, different tree ring width and latewood percent values and in different latewood reaction to weather conditions.

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

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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.

Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

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Zielinski Stephanie M

2012-01-01

Full Text Available Abstract Background Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures. Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. Methods Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. Results Median trial start-up ranged from 41 days (P25-P75 10-139 in the Netherlands to 232 days (P25-P75 98-423 in Canada (p = 0.027. The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21 per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28, representing 3.9% of eligible patients (p Conclusions In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. Trial Registration ClinicalTrials.gov: NCT00761813

Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

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Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

2014-07-16

To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

Trial 1 versus Trial 2 of the Test of Memory Malingering: Evaluating accuracy without a "gold standard".

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Mossman, Douglas; Wygant, Dustin B; Gervais, Roger O; Hart, Kathleen J

2018-01-01

This study examines the accuracy of the Test of Memory Malingering (TOMM), a frequently administered measure for evaluating effort during neurocognitive testing. In the last few years, several authors have suggested that the initial recognition trial of the TOMM (Trial 1) might be a more useful index for detecting feigned or exaggerated impairment than Trial 2, which is the source for inference recommended by the original instruction manual (Tombaugh, 1996). We used latent class modeling (LCM) implemented in a Bayesian framework to evaluate archival Trial 1 and Trial 2 data collected from 1,198 adults who had undergone outpatient forensic evaluations. All subjects were tested with 2 other performance validity tests (the Word Memory Test and the Computerized Assessment of Response Bias), and for 70% of the subjects, data from the California Verbal Learning Test-Second Edition Forced Choice trial were also available. Our results suggest that not even a perfect score on Trial 1 or Trial 2 justifies saying that an evaluee is definitely responding genuinely, although such scores imply a lower-than-base-rate probability of feigning. If one uses a Trial 2 cut-off higher than the manual's recommendation, Trial 2 does better than Trial 1 at identifying individuals who are almost certainly feigning while maintaining a negligible false positive rate. Using scores from both trials, one can identify a group of definitely feigning and very likely feigning subjects who comprise about 2 thirds of all feigners; only 1% of the members of this group would not be feigning. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Research Areas - Clinical Trials

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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.

Study of the trial subjects’ protection aspects in Phase I clinical trials and bioequivalence studies

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K. O. Zupanets

2016-03-01

Full Text Available Protection of rights, health and well-being of persons who are taking the drug during the trial (trial subjects is one of the basic principles of clinical trials (CT management. Aim. In order to study key aspects of volunteer protection, determine factors that influence these indicators and estimate the importance of ensuring their proper implementation on the clinical site (CS three survey of 135 trial subjects were carried out to evaluate the importance of assessing the impact of factors such as the procedure of signing the informed consent (IC at the CS and testing procedures for HIV / AIDS, hepatitis and others. Assessment of the quality of life of trial subjects as indirect indicator of the quality of clinical trials that ensures the proper protection of their life was the subject of the third survey. Methods and results. The general model of the relationship between the key aspects of the trial subjects protection and the factors which are providing them during the clinical trials of drugs management was substantiated, which included the main aspects of the trial subjects’ protection, protective factors and basic CT management procedures, the impact of the above factors on the possibility of providing protection aspects depends on their implementation quality. It was found that trial subjects’ protection improvement can be achieved during the IC signing process. It is necessary to ensure a higher level of volunteers understanding of the terms that could be used in the IC form. Regarding the procedure of compulsory testing for HIV/AIDS in the course of screening, we can conclude that the majority of the trial subjects believe that this procedure is an additional factor in their health protection and do not consider it as an excessive psychological pressure on them. Conclusion. Assessing the quality of life during the bioequivalence study at the CS makes possible to reach a conclusion on general well-being and satisfaction with those

Sequential Multiple Assignment Randomized Trials: An Opportunity for Improved Design of Stroke Reperfusion Trials.

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Meurer, William J; Seewald, Nicholas J; Kidwell, Kelley

2017-04-01

Modern clinical trials in stroke reperfusion fall into 2 categories: alternative systemic pharmacological regimens to alteplase and "rescue" endovascular approaches using targeted thrombectomy devices and/or medications delivered directly for persistently occluded vessels. Clinical trials in stroke have not evaluated how initial pharmacological thrombolytic management might influence subsequent rescue strategy. A sequential multiple assignment randomized trial (SMART) is a novel trial design that can test these dynamic treatment regimens and lead to treatment guidelines that more closely mimic practice. To characterize a SMART design in comparison to traditional approaches for stroke reperfusion trials. We conducted a numerical simulation study that evaluated the performance of contrasting acute stroke clinical trial designs of both initial reperfusion and rescue therapy. We compare a SMART design where the same patients are followed through initial reperfusion and rescue therapy within 1 trial to a standard phase III design comparing 2 reperfusion treatments and a separate phase II futility design of rescue therapy in terms of sample size, power, and ability to address particular research questions. Traditional trial designs can be well powered and have optimal design characteristics for independent treatment effects. When treatments, such as the reperfusion and rescue therapies, may interact, commonly used designs fail to detect this. A SMART design, with similar sample size to standard designs, can detect treatment interactions. The use of SMART designs to investigate effective and realistic dynamic treatment regimens is a promising way to accelerate the discovery of new, effective treatments for stroke. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

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

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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.

Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network

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A unique public-private collaboration today announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Squamous cell carcinom

Transparency and public accessibility of clinical trial information in Croatia: how it affects patient participation in clinical trials.

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Šolić, Ivana; Stipčić, Ana; Pavličević, Ivančica; Marušić, Ana

2017-06-15

Despite increased visibility of clinical trials through international trial registries, patients often remain uninformed of their existence, especially if they do not have access to adequate information about clinical research, including the language of the information. The aim of this study was to describe the context for transparency of clinical trials in Croatia in relation to countries in Central and Eastern Europe, and to assess how informed Croatian patients are about clinical trials and their accessibility. We assessed the transparency of clinical trials from the data available in the public domain. We also conducted an anonymous survey on a convenience sample of 257 patients visiting two family medicine offices or an oncology department in south Croatia, and members of national patients' associations. Despite legal provisions for transparency of clinical trials in Croatia, they are still not sufficiently visible in the public domain. Among countries from Central and Eastern Europe, Croatia has the fewest number of registered trials in the EU Clinical Trials Registry. 66% of the patients in the survey were aware of the existence of clinical trials but only 15% were informed about possibilities of participating in a trial. Although 58% of the respondents were willing to try new treatments, only 6% actually participated in a clinical trial. Only 2% of the respondents were aware of publicly available trial registries. Our study demonstrates that there is low transparency of clinical trials in Croatia, and that Croatian patients are not fully aware of clinical trials and the possibilities of participating in them, despite reported availability of Internet resources and good communication with their physicians. There is a need for active policy measures to increase the awareness of and access to clinical trials to patients in Croatia, particularly in their own language.

Comparison of clinical and parasitological data from controlled human malaria infection trials.

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Meta Roestenberg

Full Text Available Exposing healthy human volunteers to Plasmodium falciparum-infected mosquitoes is an accepted tool to evaluate preliminary efficacy of malaria vaccines. To accommodate the demand of the malaria vaccine pipeline, controlled infections are carried out in an increasing number of centers worldwide. We assessed their safety and reproducibility.We reviewed safety and parasitological data from 128 malaria-naïve subjects participating in controlled malaria infection trials conducted at the University of Oxford, UK, and the Radboud University Nijmegen Medical Center, The Netherlands. Results were compared to a report from the US Military Malaria Vaccine Program.We show that controlled human malaria infection trials are safe and demonstrate a consistent safety profile with minor differences in the frequencies of arthralgia, fatigue, chills and fever between institutions. But prepatent periods show significant variation. Detailed analysis of Q-PCR data reveals highly synchronous blood stage parasite growth and multiplication rates.Procedural differences can lead to some variation in safety profile and parasite kinetics between institutions. Further harmonization and standardization of protocols will be useful for wider adoption of these cost-effective small-scale efficacy trials. Nevertheless, parasite growth rates are highly reproducible, illustrating the robustness of controlled infections as a valid tool for malaria vaccine development.

Critical concepts in adaptive clinical trials

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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

Perinatal pathology in the context of a clinical trial: attitudes of neonatologists and pathologists.

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Snowdon, C; Elbourne, D R; Garcia, J

2004-05-01

To describe the attitudes of neonatologists to trial related perinatal postmortem examinations (PMs), in the light of declining perinatal PM rates and poor levels of participation in pathology studies. A qualitative study was carried out, using semistructured interviews. Twenty six neonatologists from five UK neonatal units were interviewed; five UK perinatal pathologists also contributed to the study. The professionals involved were all linked to one or both of two neonatal trials. Pathologists expressed concern over the difficulties experienced in UK perinatal pathology and the impact on research of inadequate levels of samples. The interviews with neonatologists reveal discomfort over approaching bereaved parents for PMs, and a widespread concern that parents should not be further distressed or feel under pressure to consent. Although there was support for neonatal trials, the study highlights a view that PMs may be unnecessary if the cause of death seems apparent or when a baby was born prematurely, and a devaluation of PMs among some younger staff. Poor rates of participation in pathology studies may be accounted for by a notable sense of disconnection between trial interventions and pathology studies. Neonatologists were concerned to protect vulnerable parents and varied in whether they saw this as compatible with inclusion in trial related pathology studies. Dedicated research is needed to document and gain an understanding of the consent process and should examine the usefulness and impact of consent forms. It should assess whether professionals might benefit from training, to help parents to come to their decisions.

Quantity and quality assessment of randomized controlled trials on orthodontic practice in PubMed.

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Shimada, Tatsuo; Takayama, Hisako; Nakamura, Yoshiki

2010-07-01

To find current high-quality evidence for orthodontic practice within a reasonable time, we tested the performance of a PubMed search. PubMed was searched using publication type randomized controlled trial and medical subject heading term "orthodontics" for articles published between 2003 and 2007. The PubMed search results were compared with those from a hand search of four orthodontic journals to determine the sensitivity of PubMed search. We evaluated the precision of the PubMed search result and assessed the quality of individual randomized controlled trials using the Jadad scale. Sensitivity and precision were 97.46% and 58.12%, respectively. In PubMed, of the 277 articles retrieved, 161 (58.12%) were randomized controlled trials on orthodontic practice, and 115 of the 161 articles (71.42%) were published in four orthodontic journals: American Journal of Orthodontics and Dentofacial Orthopedics, The Angle Orthodontist, the European Journal of Orthodontics, and the Journal of Orthodontics. Assessment by the Jadad scale revealed 60 high-quality randomized controlled trials on orthodontic practice, of which 45 (75%) were published in these four journals. PubMed is a highly desirable search engine for evidence-based orthodontic practice. To stay current and get high-quality evidence, it is reasonable to look through four orthodontic journals: American Journal of Orthodontics and Dentofacial Orthopedics, The Angle Orthodontist, the European Journal of Orthodontics, and the Journal of Orthodontics.

Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

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Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lee, J. Jack [Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Heymach, John V. [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Swisher, Stephen G. [Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Welsh, James W. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Zhang, Jianjun [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lin, Steven H. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Gomez, Daniel R., E-mail: dgomez@mdanderson.org [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)

2017-03-15

Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

International Nuclear Information System (INIS)

Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing; Lee, J. Jack; Heymach, John V.; Swisher, Stephen G.; Welsh, James W.; Zhang, Jianjun; Lin, Steven H.; Gomez, Daniel R.

2017-01-01

Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

Confident failures: Lapses of working memory reveal a metacognitive blind spot.

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Adam, Kirsten C S; Vogel, Edward K

2017-07-01

Working memory performance fluctuates dramatically from trial to trial. On many trials, performance is no better than chance. Here, we assessed participants' awareness of working memory failures. We used a whole-report visual working memory task to quantify both trial-by-trial performance and trial-by-trial subjective ratings of inattention to the task. In Experiment 1 (N = 41), participants were probed for task-unrelated thoughts immediately following 20% of trials. In Experiment 2 (N = 30), participants gave a rating of their attentional state following 25% of trials. Finally, in Experiments 3a (N = 44) and 3b (N = 34), participants reported confidence of every response using a simple mouse-click judgment. Attention-state ratings and off-task thoughts predicted the number of items correctly identified on each trial, replicating previous findings that subjective measures of attention state predict working memory performance. However, participants correctly identified failures on only around 28% of failure trials. Across experiments, participants' metacognitive judgments reliably predicted variation in working memory performance but consistently and severely underestimated the extent of failures. Further, individual differences in metacognitive accuracy correlated with overall working memory performance, suggesting that metacognitive monitoring may be key to working memory success.

Plato: White and Non-white Love

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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.

Altruistic reasoning in adolescent-parent dyads considering participation in a hypothetical sexual health clinical trial for adolescents.

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Chávez, Noé Rubén; Williams, Camille Y; Ipp, Lisa S; Catallozzi, Marina; Rosenthal, Susan L; Breitkopf, Carmen Radecki

2016-04-01

Altruism is a well-established reason underlying research participation. Less is known about altruism in adolescent-parent decision-making about clinical trials enrolling healthy adolescents. This qualitative investigation focused on identifying spontaneous statements of altruism within adolescent-parent (dyadic) discussions of participation in a hypothetical phase I clinical trial related to adolescent sexual health. Content analysis revealed several response patterns to each other's altruistic reasoning. Across 70 adolescent-parent dyads in which adolescents were 14-17 years of age and 91% of their parents were mothers, a majority (61%) of dyadic discussions included a statement reflecting altruism. Parents responded to adolescents' statements of altruism more frequently than adolescents responded to parents' statements. Responses included: expresses concern, reiterates altruistic reasoning, agrees with altruistic reasoning, and adds to/expands altruistic reasoning. Since an altruistic perspective was often balanced with concerns about risk or study procedures, researchers cannot assume that altruism will directly lead to study participation. Optimizing the informed consent process for early phase clinical trials involving healthy adolescents may include supporting parents to have conversations with their adolescents which will enhance their capacity to consider all aspects of trial participation.

[The endeavours by Wincentego Lutosławskiego (1863-1954) to obtain a chair of philosophy at the Jagiellonian University in Cracow].

Science.gov (United States)

Mróz, Tomasz

2005-01-01

When applying for a chair of philosophy at the Jagiellonian University in Cracow in 1891, Wincentego Lutosławskiego had already published a number of important articles as well as a doctoral dissertation, which he defended at Dorpat University. While working at the University of Kazan, Lutosławskiego had been engaged in several research sojourns abroad, including one in London. He had also made contact with another Polish specialist on Plato's philosophy, Stanisław Pawlicki, who gave a positive referral on the publication of Lutosławskiego's work On Plato's logic, part I by Akademia Umiejtno [ci (Academy of Science) in Cracow (1891); the subsequent conflict between the two scholars stemmed from differences in world-view and differences in scholarly views relating to methodology and interpretation. The application by Lutosławskiego, despite being supported by the dean of Faculty of Philosophy, Maurycy Staszewski, the only philosophy sitting on the faculty council, was rejected, and the majority of faculty council opted for Pawlicki, a renowned professor of the Faculty of Theology. Lutosławskiego continued to pursue his scholarly career abroad, publishing in several European languages, until the publication in 1897 of his famous work on Plato (The Origin and Growth of Plato's Logic). Meanwhile Pawlicki, burdened both by his teaching responsibilities and the results of the research by Lutosławskiego, was not able to complete (before his death in 1916) his History of ancient philosophy, the intention of doing which he had declared in the first volume, published in 1890. While Lutosławskiego was prevented from working in Crackow, he became - thanks to his works - a historian of ancient philosophy whose world renown has persisted until the present day. Pawlicki obtained the Chair, but his works on the history of philosophy are rarely cited today.

Socioeconomic and clinical factors are key to uncovering disparity in accrual onto therapeutic trials for breast cancer.

Science.gov (United States)

Behrendt, Carolyn E; Hurria, Arti; Tumyan, Lusine; Niland, Joyce C; Mortimer, Joanne E

2014-11-01

To monitor and address disparity in accrual, patient participation in cancer clinical trials is routinely summarized by race/ethnicity. To investigate whether confounding obscures racial/ethnic disparity in participation, all women with breast cancer treated by medical oncologists at City of Hope Comprehensive Cancer Center from 2004 through 2009 were classified by birthplace and self-reported race/ethnicity, and followed for accrual onto therapeutic trials through 2010. Undetectable on univariate analysis, significantly reduced participation by subjects of African, Asian, Eastern European, Latin American, and Middle Eastern ancestries was revealed after accounting for age, socioeconomic factors, tumor and oncologist characteristics, and intrapractice clustering of patients. Copyright © 2014 by the National Comprehensive Cancer Network.

Activity and side effects of imatinib in patients with gastrointestinal stromal tumors: data from a german multicenter trial

Directory of Open Access Journals (Sweden)

Schlemmer M

2011-05-01

Full Text Available Abstract Gastrointestinal stromal tumors (GIST are mesenchymal tumors that in the past were classified as leiomyosarcomas or leiomyomas not responding to standard sarcoma chemotherapy. In several phase I and II trials the efficacy and safety of imatinib was shown before the largest trial ever performed in a single sarcoma entity revealed response rates (CR/PR of 52%. This multicenter phase II trial presented here was performed to open access to imatinib for patients with unresectable or metastastatic GIST when the EORTC 62005 trial had been closed before imatinib was approved in Germany. It was designed to follow the best clinical response and to assess the efficacy, safety and tolerability of imatinib 400 mg/d in patients with unresectable or metastatic gastrointestinal stromal tumor. 95 patients were treated in this trial with Imatinib 400 mg/d. Four patients (4.6% attained a complete response and 26 patients (29.9% a partial response to imatinib treatment. Forty-one patients (47.1% revealed a stable disease and 16 patients (18.4% had a progressive disease. Of the progressive patients 22% showed a partial response and 67% showed stable disease after escalating the dose to 800 mg. According to SWOG tumor response classification, 66 patients (70% were free of progression within the first year of treatment. Seventy-one patients (74.7% experienced adverse events or severe adverse events with a suspected relationship to the study drug. Among these, the most common were nausea (n = 27 patients, 28.4%, eyelid edema and peripheral edema in 23 patients each (24.2%, diarrhea in 20 patients (21.1%, muscle cramps in 15 patients (15.8% and fatigue in 13 patients (13.7%. Imatinib 400 mg/d led to disease stabilisation in 81,6% of patients with unresectable or metastatic malignant GIST. Thirty-four percent of patients attained a tumor remission (partial or complete response. The safety profile of imatinib based on adverse event assessment is favorable

Patient recruitment into a multicenter randomized clinical trial for kidney disease: report of the focal segmental glomerulosclerosis clinical trial (FSGS CT).

Science.gov (United States)

Ferris, Maria; Norwood, Victoria; Radeva, Milena; Gassman, Jennifer J; Al-Uzri, Amira; Askenazi, David; Matoo, Tej; Pinsk, Maury; Sharma, Amita; Smoyer, William; Stults, Jenna; Vyas, Shefali; Weiss, Robert; Gipson, Debbie; Kaskel, Frederick; Friedman, Aaron; Moxey-Mims, Marva; Trachtman, Howard

2013-02-01

We describe the experience of the focal segmental glomerulosclerosis clinical trial (FSGS CT) in the identification and recruitment of participants into the study. This National Institutes of Health funded study, a multicenter, open-label, randomized comparison of cyclosporine versus oral dexamethasone pulses plus mycophenolate mofetil, experienced difficulty and delays meeting enrollment goals. These problems occurred despite the support of patient advocacy groups and aggressive recruitment strategies. Multiple barriers were identified including: (1) inaccurate estimates of the number of potential incident FSGS patients at participating centers; (2) delays in securing one of the test agents; (3) prolonged time between IRB approval and execution of a subcontract (mean 7.5 ± 0.8 months); (4) prolonged time between IRB approval and enrollment of the first patient at participating sites (mean 19.6 ± 1.4 months); and (5) reorganization of clinical coordinating core infrastructure to align resources with enrollment. A Web-based anonymous survey of site investigators revealed site-related barriers to patient recruitment. The value of a variety of recruitment tools was of marginal utility in facilitating patient enrollment. We conclude that improvements in the logistics of study approval and regulatory start-up and testing of promising novel agents are important factors in promoting enrollment into randomized clinical trials in nephrology. © 2013 Wiley Periodicals, Inc.

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...

Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act.

Science.gov (United States)

Logvinov, Ilana

2014-03-01

Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection. Copyright © 2014 Elsevier Inc. All rights reserved.

Will and Wille | Wright | Shakespeare in Southern Africa

African Journals Online (AJOL)

Abstract. Ronald Gray. Shakespeare on Love: The Sonnets and Plays in Relation to Plato's Symposium, Alchemy, Christianity and Renaissance Neo-Platonism. Newcastle: Cambridge Scholars Publishing, 2011.

Ongoing EEG phase as a trial-by-trial predictor of perceptual and attentional variability

Directory of Open Access Journals (Sweden)

Rufin eVanRullen

2011-04-01

Full Text Available Even in well-controlled laboratory environments, apparently identical repetitions of an experimental trial can give rise to highly variable perceptual outcomes and behavioral responses. This variability is generally discarded as a reflection of intrinsic noise in neuronal systems. However, part of this variability may be accounted for by trial-by-trial fluctuations of the phase of ongoing oscillations at the moment of stimulus presentation. For example, the phase of an EEG oscillation reflecting the rapid waxing and waning of sustained attention can predict the perception of a subsequent visual stimulus at threshold. Similar ongoing periodicities account for a portion of the trial-by-trial variability of visual reaction times. We review the available experimental evidence linking ongoing EEG phase to perceptual and attentional variability, and the corresponding methodology. We propose future tests of this relation, and discuss the theoretical implications for understanding the neuronal dynamics of sensory perception.

Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency

DEFF Research Database (Denmark)

Berendt, Louise; Petersen, Lene Grejs; Bach, Karin Friis

2017-01-01

OBJECTIVE: To characterize and quantify barriers towards the publication of academic drug trials. STUDY DESIGN: We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates...... of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines...... agencies since 2004. RESULTS: A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were...

OARSI Clinical Trials Recommendations: Hand imaging in clinical trials in osteoarthritis.

Science.gov (United States)

Hunter, D J; Arden, N; Cicuttini, F; Crema, M D; Dardzinski, B; Duryea, J; Guermazi, A; Haugen, I K; Kloppenburg, M; Maheu, E; Miller, C G; Martel-Pelletier, J; Ochoa-Albíztegui, R E; Pelletier, J-P; Peterfy, C; Roemer, F; Gold, G E

2015-05-01

Tremendous advances have occurred in our understanding of the pathogenesis of hand osteoarthritis (OA) and these are beginning to be applied to trials targeted at modification of the disease course. The purpose of this expert opinion, consensus driven exercise is to provide detail on how one might use and apply hand imaging assessments in disease modifying clinical trials. It includes information on acquisition methods/techniques (including guidance on positioning for radiography, sequence/protocol recommendations/hardware for MRI); commonly encountered problems (including positioning, hardware and coil failures, sequences artifacts); quality assurance/control procedures; measurement methods; measurement performance (reliability, responsiveness, validity); recommendations for trials; and research recommendations. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

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

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis.

Science.gov (United States)

Kloppenburg, M; Maheu, E; Kraus, V B; Cicuttini, F; Doherty, M; Dreiser, R-L; Henrotin, Y; Jiang, G-L; Mandl, L; Martel-Pelletier, J; Nelson, A E; Neogi, T; Pelletier, J-P; Punzi, L; Ramonda, R; Simon, L S; Wang, S

2015-05-01

Hand osteoarthritis (OA) is a very frequent disease, but yet understudied. However, a lot of works have been published in the past 10 years, and much has been done to better understand its clinical course and structural progression. Despite this new knowledge, few therapeutic trials have been conducted in hand OA. The last OARSI recommendations for the conduct of clinical trials in hand OA dates back to 2006. The present recommendations aimed at updating previous recommendations, by incorporating new data. The purpose of this expert opinion, consensus driven exercise is to provide evidence-based guidance on the design, execution and analysis of clinical trials in hand OA, where published evidence is available, supplemented by expert opinion, where evidence is lacking, to perform clinical trials in hand OA, both for symptom and for structure-modification. They indicate core outcome measurement sets for studies in hand OA, and list the methods and instruments that should be used to measure symptoms or structure. For both symptom- and structure-modification, at least pain, physical function, patient global assessment, HR-QoL, joint activity and hand strength should be assessed. In addition, for structure-modification trials, structural progression should be measured by radiographic changes. We also provide a research agenda listing many unsolved issues that seem to most urgently need to be addressed from the perspective of performing "good" clinical trials in hand OA. These updated OARSI recommendations should allow for better standardizing the conduct of clinical trials in hand OA in the next future. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

The effect of funding sources on donepezil randomised controlled trial outcome: a meta-analysis.

Science.gov (United States)

Killin, Lewis O J; Russ, Tom C; Starr, John M; Abrahams, Sharon; Della Sala, Sergio

2014-04-07

To investigate whether there is a difference in the treatment effect of donepezil on cognition in Alzheimer disease between industry-funded and independent randomised controlled trials. Fixed effects meta-analysis of standardised effects of donepezil on cognition as measured by the Mini Mental State Examination and the Alzheimer's Disease Assessment Scale-cognitive subscale. Studies included in the meta-analyses reported in the National Institute for Health and Care Excellence (NICE) technical appraisal 217 updated with new studies through a PubMed search. Inclusion criteria were double-blind, placebo-controlled trials of any length comparing patients diagnosed with probable Alzheimer disease (according to the NINCDS-ADRDA/DSM-III/IV criteria) taking any dosage of donepezil. Studies of combination therapies (eg, donepezil and memantine) were excluded, as were studies that enrolled patients with a diagnosis of Alzheimer disease associated with other disorders (eg, Parkinson's disease and Down's syndrome). Our search strategy identified 14 relevant trials (4 independent) with suitable data. Trials sponsored by pharmaceutical companies reported a larger effect of donepezil on standardised cognitive tests than trials published by independent research groups (standardised mean difference (SMD)=0.46, 95% CI 0.37 to 0.55 vs SMD=0.33, 95% CI 0.18 to 0.48, respectively). This difference remained when only data representing change up to 12 weeks from baseline were analysed (industry SMD=0.44, 95% CI 0.34 to 0.53 vs independent SMD=0.35, 95% CI 0.18 to 0.52). Analysis revealed that the effect of funding as a moderator variable of study heterogeneity was not statistically significant at either time point. The effect size of donepezil on cognition is larger in industry-funded than independent trials and this is not explained by the longer duration of industry-funded trials. The lack of a statistically significant moderator effect may indicate that the differences are due to

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 ...

Reasons for participating in a randomised clinical trial: The volunteers' voices in the COSTOP trial in Uganda

Directory of Open Access Journals (Sweden)

Agnes Ssali

2017-09-01

Full Text Available Introduction: The reasons why research participants join clinical trials remains an area of inquiry especially in low and middle income countries. Methods: We conducted exit interviews with participants who took part in a trial which aimed to evaluate whether long term prophylaxis with cotrimoxazole can be safely discontinued among adults who have been stabilised on antiretroviral therapy (ART. Participants were all reported to be stable on ART and had been participating in the trial for between 12 and 36 months; at the end of the trial participants were interviewed using a semi-structured questionnaire. One of the objectives of the exit interview was to find out what motivated the participants to join the research. Results: Participants gave personal reasons for joining the trial, frequently linked to their health and well-being as well as reduction of pill burden. Conclusion: We conclude that underlying reasons for joining clinical trials may extend beyond or can be different from the rationale given to the participants before enrolment by the research team. The reasons that motivate enrolment to clinical trials and research in general require further investigation in different settings. Trial registration number: ISRCTN44723643. Keywords: Randomised clinical trials, Volunteers, Participants

OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis.

Science.gov (United States)

Kraus, V B; Blanco, F J; Englund, M; Henrotin, Y; Lohmander, L S; Losina, E; Önnerfjord, P; Persiani, S

2015-05-01

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 both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute treatment at a time more amenable to disease modification. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Assessing the readability of ClinicalTrials.gov.

Science.gov (United States)

Wu, Danny T Y; Hanauer, David A; Mei, Qiaozhu; Clark, Patricia M; An, Lawrence C; Proulx, Joshua; Zeng, Qing T; Vydiswaran, V G Vinod; Collins-Thompson, Kevyn; Zheng, Kai

2016-03-01

ClinicalTrials.gov serves critical functions of disseminating trial information to the public and helping the trials recruit participants. This study assessed the readability of trial descriptions at ClinicalTrials.gov using multiple quantitative measures. The analysis included all 165,988 trials registered at ClinicalTrials.gov as of April 30, 2014. To obtain benchmarks, the authors also analyzed 2 other medical corpora: (1) all 955 Health Topics articles from MedlinePlus and (2) a random sample of 100,000 clinician notes retrieved from an electronic health records system intended for conveying internal communication among medical professionals. The authors characterized each of the corpora using 4 surface metrics, and then applied 5 different scoring algorithms to assess their readability. The authors hypothesized that clinician notes would be most difficult to read, followed by trial descriptions and MedlinePlus Health Topics articles. Trial descriptions have the longest average sentence length (26.1 words) across all corpora; 65% of their words used are not covered by a basic medical English dictionary. In comparison, average sentence length of MedlinePlus Health Topics articles is 61% shorter, vocabulary size is 95% smaller, and dictionary coverage is 46% higher. All 5 scoring algorithms consistently rated CliniclTrials.gov trial descriptions the most difficult corpus to read, even harder than clinician notes. On average, it requires 18 years of education to properly understand these trial descriptions according to the results generated by the readability assessment algorithms. Trial descriptions at CliniclTrials.gov are extremely difficult to read. Significant work is warranted to improve their readability in order to achieve CliniclTrials.gov's goal of facilitating information dissemination and subject recruitment. Published by Oxford University Press on behalf of the American Medical Informatics Association 2015. This work is written by US Government

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.

Measurement of neutron spectra in varied environments by the foil-activation method with arbitrary trials

International Nuclear Information System (INIS)

Kelly, J.G.; Vehar, D.W.

1987-12-01

Neutron spectra have been measured by the foil-activation method in 13 different environments in and around the Sandia Pulsed Reactor, the White Sands Missile Range Fast Burst Reactor, and the Sandia Annular Core Research Reactor. The spectra were obtained by using the SANDII code in a manner that was not dependent on the initial trial. This altered technique is better suited for the determination of spectra in environments that are difficult to predict by calculation, and it tends to reveal features that may be biased out by the use of standard trial-dependent methods. For some of the configurations, studies have also been made of how well the solution is determined in each energy region. The experimental methods and the techniques used in the analyses are thoroughly explained. 34 refs., 51 figs., 40 tabs

Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial.

Science.gov (United States)

Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C

2016-06-01

The Systolic Blood Pressure Intervention Trial is a multicenter, randomized clinical trial of 9361 participants with hypertension who are ≥50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal recruitment strategies and lessons learned during recruitment of the Systolic Blood Pressure Intervention Trial cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥75 years, women, and minorities. In collaboration with the National Institutes of Health Project Office and Systolic Blood Pressure Intervention Trial Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began on 8 November 2010 and ended on 15 March 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Recruitment was scheduled to last 24 months to enroll a target of 9250 participants; in just over 28 months, the trial enrolled 9361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by Systolic Blood Pressure Intervention Trial staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, Internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized/number screened) was 64% (9361 randomized/14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those aged ≥75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional

Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative.

Science.gov (United States)

Greenberg, Rachel G; Corneli, Amy; Bradley, John; Farley, John; Jafri, Hasan S; Lin, Li; Nambiar, Sumathi; Noel, Gary J; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

2018-03-01

Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator (those who have never served as a clinical trial investigator) providers are essential to recruitment of pediatric patients, but little is known regarding the specific barriers that limit pediatric providers from participating in and referring their patients to clinical trials. We conducted an online survey of pediatric providers from a wide variety of practice types across the United States to evaluate their attitudes and awareness of pediatric clinical trials. Using a 4-point Likert scale, providers described their perception of potential barriers to their practice serving as a site for pediatric clinical trials. Of the 136 providers surveyed, 52/136 (38%) had previously referred a pediatric patient to a trial, and only 17/136 (12%) had ever been an investigator for a pediatric trial. Lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. Overall, providers perceived greater challenges related to parental concerns and parent or child logistical barriers than study implementation and ethics or regulatory barriers as barriers to their practice serving as a trial site. Providers who had previously been an investigator for a pediatric trial were less likely to be concerned with potential barriers than non-investigators. Understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation.

Design of Phase II Non-inferiority Trials.

Science.gov (United States)

Jung, Sin-Ho

2017-09-01

With the development of inexpensive treatment regimens and less invasive surgical procedures, we are confronted with non-inferiority study objectives. A non-inferiority phase III trial requires a roughly four times larger sample size than that of a similar standard superiority trial. Because of the large required sample size, we often face feasibility issues to open a non-inferiority trial. Furthermore, due to lack of phase II non-inferiority trial design methods, we do not have an opportunity to investigate the efficacy of the experimental therapy through a phase II trial. As a result, we often fail to open a non-inferiority phase III trial and a large number of non-inferiority clinical questions still remain unanswered. In this paper, we want to develop some designs for non-inferiority randomized phase II trials with feasible sample sizes. At first, we review a design method for non-inferiority phase III trials. Subsequently, we propose three different designs for non-inferiority phase II trials that can be used under different settings. Each method is demonstrated with examples. Each of the proposed design methods is shown to require a reasonable sample size for non-inferiority phase II trials. The three different non-inferiority phase II trial designs are used under different settings, but require similar sample sizes that are typical for phase II trials.

The role of lymphadenectomy in endometrial cancer: was the ASTEC trial doomed by design and are we destined to repeat that mistake?

Science.gov (United States)

Naumann, R Wendel

2012-07-01

This study examines the design of previous and future trials of lymph node dissection in endometrial cancer. Data from previous trials were used to construct a decision analysis modeling the risk of lymphatic spread and the effects of treatment on patients with endometrial cancer. This model was then applied to previous trials as well as other future trial designs that might be used to address this subject. Comparing the predicted and actual results in the ASTEC trial, the model closely mimics the survival results with and without lymph node dissection for the low and high risk groups. The model suggests a survival difference of less than 2% between the experimental and control arms of the ASTEC trial under all circumstances. Sensitivity analyses reveal that these conclusions are robust. Future trial designs were also modeled with hysterectomy only, hysterectomy with radiation in intermediate risk patients, and staging with radiation only with node positive patients. Predicted outcomes for these approaches yield survival rates of 88%, 90%, and 93% in clinical stage I patients who have a risk of pelvic node involvement of approximately 7%. These estimates were 78%, 82%, and 89% in intermediate risk patients who have a risk of nodal spread of approximately 15%. This model accurately predicts the outcome of previous trials and demonstrates that even if lymph node dissection was therapeutic, these trials would have been negative due to study design. Furthermore, future trial designs that are being considered would need to be conducted in high-intermediate risk patients to detect any difference. Copyright © 2012 Elsevier Inc. All rights reserved.

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

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)

Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual.

Science.gov (United States)

Tang, Chad; Hess, Kenneth R; Sanders, Dwana; Davis, Suzanne E; Buzdar, Aman U; Kurzrock, Razelle; Lee, J Jack; Meric-Bernstam, Funda; Hong, David S

2017-03-15

Purpose: Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center (Houston, TX) and analyzed their effects on the trial activation timeline and enrolment. Experimental Design: Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database, we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results: We identified three facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship [industry (133 ICT and 133 non-ICT trials) or institutional (68 ICT and 68 non-ICT trials)]. ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrolment (median difference of 0.3 months for industry vs. 1.2 months for institutional; all matched P infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual. Clin Cancer Res; 23(6); 1407-13. ©2016 AACR . ©2016 American Association for Cancer Research.

Commentary: considerations for using the 'Trials within Cohorts' design in a clinical trial of an investigational medicinal product.

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Bibby, Anna C; Torgerson, David J; Leach, Samantha; Lewis-White, Helen; Maskell, Nick A

2018-01-08

The 'trials within cohorts' (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort. To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule. We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future.

Monist and Dualist Tendencies in Platonism before Plotinus

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Dillon, John

2015-04-01

Full Text Available The author argues that the Platonism that Plotinus inherits – setting aside Ammonius Saccas, of whom we know all too little – is by the later second century distinctly dualist in tendency, and is able, especially in the case of Plutarch, to quote Plato to its purpose. Plato himself, though, as the author maintains, is, despite appearances to the contrary, what one might term a ‘modified monist’. That is to say, he fully recognizes the degree of imperfection and evil in the world, and holds it to be ineradicable, but he does not in the last resort believe in a positive countervailing force to the Good or the One. What we have is simply a negative force, whether Indefinite Dyad, disorderly World-Soul, or Receptacle, which is an inevitable condition of their being a world at all, but which, as a side-effect of introducing diversity, generates various sorts of imperfection. It is this scenario that justifies his follower Hermodorus in declaring that Plato recognizes only a single first principle, and it to this sort of monism – if anything, in a more pronounced form – that Plotinus returns. The article is published in a Russian translation in Vol. II, issue 1

Monist and Dualist Tendencies in Platonism before Plotinus (in Russian

Directory of Open Access Journals (Sweden)

Dillon, John

2008-01-01

Full Text Available The author argues that the Platonism that Plotinus inherits – setting aside Ammonius Saccas, of whom we know all too little – is by the later second century distinctly dualist in tendency, and is able, especially in the case of Plutarch, to quote Plato to its purpose. Plato himself, though, as the author maintains, is, despite appearances to the contrary, what one might term a ‘modified monist’. That is to say, he fully recognizes the degree of imperfection and evil in the world, and holds it to be ineradicable, but he does not in the last resort believe in a positive countervailing force to the Good or the One. What we have is simply a negative force, whether Indefinite Dyad, disorderly World-Soul, or Receptacle, which is an inevitable condition of their being a world at all, but which, as a side-effect of introducing diversity, generates various sorts of imperfection. It is this scenario that justifies his follower Hermodorus in declaring that Plato recognizes only a single first principle, and it to this sort of monism – if anything, in a more pronounced form – that Plotinus returns. The article is published in its English version in Vol. I, issue 1

The Methodological Analysis of the Plato’s Doctrine About Space and the Person in Dialogue “Timaeus”

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Viacheslav Meshkov

2016-10-01

Full Text Available The paper focus is on the main methodological sets of Plato which substantially influenced his philosophic and scientific thinking, expressed in the dialogue ‘Timaeus’, as well as defined the specific of his doctrine in relation to the cosmos and human being: the principle of substantial perfection, deterministic approach, a tendency to analyze the empiric material with the means of mathematical objects. Plato’s understanding of the cosmos and human body as lively, holistic constructions enabled their fruitful systematic studies. Shaping his teaching on the soul and the body of human being, Plato endeavored to solve one of the most complicated tasks: to establish the first theoretical, mathematised system, and under such conditions to fill the pure language of observations with ideal constructs. The author shows that one of the most important scientific achievements of the Athenian philosopher was the use of the thinking constructions of geometrical triangles, which made possible creating of the theoretical models of living organisms, with explaining their nature and functioning that was one among the first in the history of science. Moreover Plato was the first in the history of science who filled with the theoretical contents not the first elements only, but all the examined material objects.

Performance and Philosophy Now

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Tasoula Kallenou

2015-11-01

Full Text Available Was Plato the first philosophical dramatist to explore philosophical ideas through dramatic content, introducing dramatic structures currently in line with contemporary theatre? If Plato was an influential figure for philosophers as well as theatre-makers, it can arguably be said that he was a silent pioneer in creating the newly defined discipline of Performance Philosophy. There is an obvious polarity between performance and philosophy since both disciplines are on the quest of exploring and presenting what life is. At least this can be said of ancient Greek and Roman philosophy. Conceived as “biou techne” the art of living, Greek and Roman philosophers, especially the Epicureans, Stoics and Skeptics, saw philosophy as a way of conceiving what a good life is (a life worth living and pursuing its practical realization for the attainment of eudemonia. Plato was arguably the first significant philosopher to explore philosophical ideas through dramatic content, introducing dramatic structures currently in line with contemporary theatre views. As such, he can be seen as an influential figure for theatre makers as well as for philosophers. Plato’s artistic intention was to uncover the artist that lacked substance and support the knowledgeable creative philosophical mind that besides instant emotional pleasure has to contribute in social development.

Quality Assurance for Clinical Trials

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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

Trial-to-trial dynamics of selective long-term-memory retrieval with continuously changing retrieval targets.

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Kizilirmak, Jasmin M; Rösler, Frank; Khader, Patrick H

2014-10-01

How do we control the successive retrieval of behaviorally relevant information from long-term memory (LTM) without being distracted by other potential retrieval targets associated to the same retrieval cues? Here, we approach this question by investigating the nature of trial-by-trial dynamics of selective LTM retrieval, i.e., in how far retrieval in one trial has detrimental or facilitatory effects on selective retrieval in the following trial. Participants first learned associations between retrieval cues and targets, with one cue always being linked to three targets, forming small associative networks. In successive trials, participants had to access either the same or a different target belonging to either the same or a different cue. We found that retrieval times were faster for targets that had already been relevant in the previous trial, with this facilitatory effect being substantially weaker when the associative network changed in which the targets were embedded. Moreover, staying within the same network still had a facilitatory effect even if the target changed, which became evident in a relatively higher memory performance in comparison to a network change. Furthermore, event-related brain potentials (ERPs) showed topographically and temporally dissociable correlates of these effects, suggesting that they result from combined influences of distinct processes that aid memory retrieval when relevant and irrelevant targets change their status from trial to trial. Taken together, the present study provides insight into the different processing stages of memory retrieval when fast switches between retrieval targets are required. Copyright © 2014 Elsevier Inc. All rights reserved.

Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency.

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Berendt, Louise; Petersen, Lene Grejs; Bach, Karin Friis; Poulsen, Henrik Enghusen; Dalhoff, Kim

2017-01-01

To characterize and quantify barriers towards the publication of academic drug trials. We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines agencies since 2004. A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were 92% (95% CI: 88-97%) and 93% (95% CI: 89-97%) respectively. The publication rate of completed trials was 73% (95% CI: 62-79%). RCTs were published faster than non-RCTs (quartile time to publication 2.9 vs. 3.1 years, p = 0.0412). Many academic drug trials are left unpublished. Main barriers towards publication were related to the process from completion to publication. Hence, there is much to gain by facilitating the process from analysis to publication. Research institutions and funders should actively influence this process, e.g. by requiring the publication of trial results within a given time after completion.

The clinical significance of 5% change in vital capacity in patients with idiopathic pulmonary fibrosis: extended analysis of the pirfenidone trial

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Nakata Koichiro

2011-07-01

Full Text Available Abstract Background Our phase III clinical trial of pirfenidone for patients with idiopathic pulmonary fibrosis (IPF revealed the efficacy in reducing the decline of vital capacity (VC and increasing the progression-free survival (PFS time by pirfenidone. Recently, marginal decline in forced VC (FVC has been reported to be associated with poor outcome in IPF. We sought to evaluate the efficacy of pirfenidone from the aspects of 5% change in VC. Methods Improvement ratings based on 5% change in absolute VC, i.e., "improved (VC ≥ 5% increase", "stable (VC Results In the comparison of the improvement ratings, the statistically significant differences were clearly revealed at months 3, 6, 9, and 12 between pirfenidone and placebo groups. Risk reductions by pirfenidone to placebo were approximately 35% over the study period. In the comparison of the PFS times, statistically significant difference was also observed between pirfenidone and placebo groups. The positive/negative predictive values in placebo and pirfenidone groups were 86.1%/50.8% and 87.1%/71.7%, respectively. Further, the baseline characteristics of patients worsened at month 3 had generally severe impairment, and their clinical outcomes including mortality were also significantly worsened after 1 year. Conclusions The efficacy of pirfenidone in Japanese phase III trial was supported by the rating of 5% decline in VC, and the VC changes at month 3 may be used as a prognostic factor of IPF. Trial Registration This clinical trial was registered with the Japan Pharmaceutical Information Center (JAPIC on September 13th, 2005 (Registration Number: JAPICCTI-050121.

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

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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

A Sensitivity Approach to Identification of Ship Dynamics From Sea Trial Data

DEFF Research Database (Denmark)

Blanke, M.; Knudsen, Morten

1998-01-01

Non-linear mathematical models of ships comprise one hundred parameters, or more, and differences between full-scale trials and model tests are difficult to associate with individual terms. Direct identification of parameters would be advantageous. The paper employs a sensitivity approach...... in an attempt to achieve this. Using the method on full-scale data from a containership, a good fit in roll and yaw is obtained, but the method reveals that this does not imply good determination of individual parameters. The sensitivity method is found to be easily applied for both identification...

Microbicide clinical trial adherence: insights for introduction.

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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.

Shedding light on research participation effects in behaviour change trials: a qualitative study examining research participant experiences.

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MacNeill, Virginia; Foley, Marian; Quirk, Alan; McCambridge, Jim

2016-01-29

The sequence of events in a behaviour change trial involves interactions between research participants and the trial process. Taking part in such a study has the potential to influence the behaviour of the participant, and if it does, this can engender bias in trial outcomes. Since participants' experience has received scant attention, the aim of this study is thus to generate hypotheses about which aspects of the conduct of behaviour change trials might matter most to participants, and thus have potential to alter subsequent behaviours and bias trial outcomes Twenty participants were opportunistically screened for a health compromising behaviour (unhealthy diet, lack of exercise, smoking or alcohol consumption) and recruited if eligible. Semi structured face to face interviews were conducted, after going through the usual processes involved in trial recruitment, baseline assessment and randomisation. Participants were given information on the contents of an intervention or control condition in a behaviour change trial, which was not actually implemented. Three months later they returned to reflect on these experiences and whether they had any effect on their behaviour during the intervening period. Data from the latter interview were analysed thematically using a modified grounded theory approach. The early processes of trial participation raised awareness of unhealthy behaviours, although most reported having had only fleeting intentions to change their behaviour as a result of taking part in this study, in the absence of interventions. However, careful examination of the accounts revealed evidence of subtle research participation effects, which varied according to the health behaviour, and its perceived social acceptability. Participants' relationships with the research study were viewed as somewhat important in stimulating thinking about whether and how to make lifestyle changes. These participants described no dramatic impacts attributable to taking part in

Massed Trials versus Trials Embedded into Game Play: Child Outcomes and Preference

Science.gov (United States)

Ledford, Jennifer R.; Chazin, Kate T.; Harbin, Emilee R.; Ward, Sarah E.

2017-01-01

Limited data are available regarding how response prompting procedures should be used in early childhood settings. The purpose of this study was to compare the efficiency of progressive time delay instruction presented via two trial arrangements: massed and embedded. During massed trial sessions, a short instructional session was conducted,…

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...

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...

Australasian Experience and Trials in Sentinel Lymph Node Biopsy: The RACS SNAC Trial

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Owen A. Ung

2004-10-01

Conclusions: The SNAC trial is one of the fastest accruing clinical trials in Australasia. It is on track to determine whether differences in morbidity, with equivalent cancer-related outcomes, exist between SLNB and AC for women with early breast cancer.

A randomized controlled Alzheimer's disease prevention trial's evolution into an exposure trial: the PREADViSE Trial.

Science.gov (United States)

Kryscio, R J; Abner, E L; Schmitt, F A; Goodman, P J; Mendiondo, M; Caban-Holt, A; Dennis, B C; Mathews, M; Klein, E A; Crowley, J J

2013-01-01

To summarize the ongoing prevention of Alzheimer's disease (AD) by vitamin E and selenium (PREADViSE) trial as an ancillary study to SELECT (a large prostate cancer prevention trial) and to present the blinded results of the first year as an exposure study. PREADViSE was designed as a double blind randomized controlled trial (RCT). SELECT terminated after median of 5.5 years of exposure to supplements due to a futility analysis. Both trials then converted into an exposure study. In the randomized component PREADViSE enrolled 7,547 men age 62 or older (60 if African American). Once the trial terminated 4,246 of these men volunteered for the exposure study. Demographics were similar for both groups with exposure volunteers having baseline mean age 67.3 ± 5.2 years, 15.3 ± 2.4 years of education, 9.8% African Americans, and 22.0% reporting a family history of dementia. In the RCT men were randomly assigned to either daily doses of 400 IU of vitamin E or placebo and 200 µg of selenium or placebo using a 2x2 factorial structure. In the RCT, participants completed the memory impairment screen (MIS), and if they failed, underwent a longer screening (based on an expanded Consortium to Establish a Registry in AD [CERAD] battery). CERAD failure resulted in visits to their clinician for medical examination with records of these examinations forwarded to the PREADViSE center for further review. In the exposure study, men are contacted by telephone and complete the telephone version of the memory impairment screen (MIS-T) screen. If they fail the MIS-T, a modified telephone interview of cognitive status (TICS-M) exam is given. A failed TICS-M exam also leads to a visit to their clinician for an in-depth examination and forwarding of records for a centralized consensus diagnosis by expert clinicians. A subgroup of the men who pass the MIS-T also take the TICS-M exam for validation purposes. While this ancillary trial was open to all 427 SELECT clinical sites, only 130 (30

The Anglo-Scandinavian Cardiac Outcomes Trial lipid lowering arm: extended observations 2 years after trial closure

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Sever, Peter S; Poulter, Neil R; Dahlof, Bjorn

2008-01-01

Aims To determine the cardiovascular benefits in those originally assigned atorvastatin in the Anglo-Scandinavian Cardiac Outcomes Trial-2.2 years after closure of the lipid-lowering arm of the trial (ASCOT-LLA). Methods and results The Blood Pressure Lowering Arm of the ASCOT trial (ASCOT......-BPLA) compared two different antihypertensive treatment strategies on cardiovascular outcomes. ASCOT-LLA was a double-blind placebo-controlled trial of atorvastatin in those enrolled into ASCOT-BPLA with total cholesterol concentrations at baseline of ... enrolled in ASCOT-BPLA and 10 305 were further assigned either atorvastatin, 10 mg, or placebo. ASCOT-LLA was stopped prematurely after a median 3.3 years follow-up because of substantial cardiovascular benefits in those assigned atorvastatin. Trial physicians were invited to offer atorvastatin to all...

Age-related differences in the neural correlates of trial-to-trial variations of reaction time

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Nancy E. Adleman

2016-06-01

Full Text Available Intra-subject variation in reaction time (ISVRT is a developmentally-important phenomenon that decreases from childhood through young adulthood in parallel with the development of executive functions and networks. Prior work has shown a significant association between trial-by-trial variations in reaction time (RT and trial-by-trial variations in brain activity as measured by the blood-oxygenated level-dependent (BOLD response in functional magnetic resonance imaging (fMRI studies. It remains unclear, however, whether such “RT-BOLD” relationships vary with age. Here, we determined whether such trial-by-trial relationships vary with age in a cross-sectional design. We observed an association between age and RT-BOLD relationships in 11 clusters located in visual/occipital regions, frontal and parietal association cortex, precentral/postcentral gyrus, and thalamus. Some of these relationships were negative, reflecting increased BOLD associated with decreased RT, manifesting around the time of stimulus presentation and positive several seconds later. Critically for present purposes, all RT-BOLD relationships increased with age. Thus, RT-BOLD relationships may reflect robust, measurable changes in the brain-behavior relationship across development.

Internet trials: participant experiences and perspectives.

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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

EL PLACER: ESCENARIO ESTÉTICO-VITALIZADOR DE LA EDUCACIÓN | PLEASURE: AESTHETIC VITALIZING-DESIGN OF EDUCATION

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Yolimar Herrera Bastardo

2016-08-01

Full Text Available The purpose of this article was to reveal the historicity of the category pleasure as the foundation of an aesthetic - vitalizing proposal of education. For this, genealogy is the alternative to build another rationality around pleasure. In that sense, the following themes were discussed: a pleasure, as a determinant factor in life. Woven ethical - aesthetic reconfigurator of education; b pleasure of divinity and of psychic life: aesthetic overlaps in pedagogy, c pleasure of modernity: scenario for the education of the future. With the theoretical contributions of Plato, Aristotle, Epicurus, St. Augustine, Freud, Foucault, Onfray and Lipovestky, discursive paths were rewritten in relation to pleasure and were placed interweaved with the educational context to reveal lines of escape that in the aesthetic ground make education a space for creativity, inter-subjectivity and otherness. In conclusion, the vitalizing power of pleasure makes the social meaning of education to transform towards the formation of a new citizen more human in the understanding of aiming the common good.

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.

Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative

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Rachel G. Greenberg

2018-03-01

Of the 136 providers surveyed, 52/136 (38% had previously referred a pediatric patient to a trial, and only 17/136 (12% had ever been an investigator for a pediatric trial. Lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. Overall, providers perceived greater challenges related to parental concerns and parent or child logistical barriers than study implementation and ethics or regulatory barriers as barriers to their practice serving as a trial site. Providers who had previously been an investigator for a pediatric trial were less likely to be concerned with potential barriers than non-investigators. Understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation.

Trial-to-trial reoptimization of motor behavior due to changes in task demands is limited.

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Orban de Xivry J-J

Full Text Available Each task requires a specific motor behavior that is tuned to task demands. For instance, writing requires a lot of accuracy while clapping does not. It is known that the brain adjusts the motor behavior to different task demands as predicted by optimal control theory. In this study, the mechanism of this reoptimization process is investigated by varying the accuracy demands of a reaching task. In this task, the width of the reaching target (0.5 or 8 cm was varied either on a trial-to-trial basis (random schedule or in blocks (blocked schedule. On some trials, the hand of the subjects was clamped to a rectilinear trajectory that ended 2 cm on the left or right of the target center. The rejection of this perturbation largely varied with target width in the blocked schedule but not in the random schedule. That is, subjects exhibited different motor behavior in the different schedules despite identical accuracy demands. Therefore, while reoptimization has been considered immediate and automatic, the differences in motor behavior observed across schedules suggest that the reoptimization of the motor behavior is neither happening on a trial-by-trial basis nor obligatory. The absence of trial-to-trial mechanisms, the inability of the brain to adapt to two conflicting task demands and the existence of a switching cost are discussed as possible sources of the non-optimality of motor behavior during the random schedule.

A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

Science.gov (United States)

Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

2014-01-01

Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. SLEEP 2014;37(9):1553-1563. PMID:25142566

Healthcare professionals' views of the use and administration of two salvage therapy drugs for acute ulcerative colitis: a nested qualitative study within the CONSTRUCT trial.

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Clement, Clare; Rapport, Frances; Seagrove, Anne; Alrubaiy, Laith; Williams, John

2017-02-22

Insight into healthcare professionals' views and experiences of the use of ciclosporin and infliximab as salvage therapies for acute ulcerative colitis (UC) and how this may affect participation in a comparison trial is lacking. The study aimed to capture views and opinions of healthcare professionals about the two drugs within the CONSTRUCT trial. An interview-based qualitative study using Framework Analysis embedded within an open-label, pragmatic randomised trial. National Health Service Health Boards and Trusts, including large teaching and district hospitals in England, Scotland and Wales. Principal Investigators (PIs) for trial sites (who were all consultant gastroenterologists) and nurses responsible for administering and monitoring the salvage therapy drugs across trial sites. 15 PIs and 8 nurses recruited from a range of sites stratified by site recruitment rates were interviewed. Interviews revealed that professionals made judgements regarding the salvage therapies largely based on experience of giving the two drugs and perceptions of effectiveness and adverse side effects. A clear preference for infliximab among nurses was revealed, largely based on experiences of administration and drug handling, with some doctors strongly favouring infliximab based on experience of prescribing the drug as well as patient views and the existing evidence base. Most doctors were more equivocal, and all were prepared to suspend preferences and wait for evidence of effectiveness and safety from the CONSTRUCT trial. PIs also questioned guidelines around drug use and restrictions placed on personal autonomy in delivering best patient care. Findings highlight healthcare professionals' preference for the salvage treatment, infliximab in treating steroid-resistant UC, largely based on resource intensive nursing requirements of intravenous administration of ciclosporin. Not all doctors expressed this preference, being more equivocal, and all professionals were content to suspend

Suppression of the µ rhythm during speech and non-speech discrimination revealed by independent component analysis: implications for sensorimotor integration in speech processing.

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Bowers, Andrew; Saltuklaroglu, Tim; Harkrider, Ashley; Cuellar, Megan

2013-01-01

Constructivist theories propose that articulatory hypotheses about incoming phonetic targets may function to enhance perception by limiting the possibilities for sensory analysis. To provide evidence for this proposal, it is necessary to map ongoing, high-temporal resolution changes in sensorimotor activity (i.e., the sensorimotor μ rhythm) to accurate speech and non-speech discrimination performance (i.e., correct trials.). Sixteen participants (15 female and 1 male) were asked to passively listen to or actively identify speech and tone-sweeps in a two-force choice discrimination task while the electroencephalograph (EEG) was recorded from 32 channels. The stimuli were presented at signal-to-noise ratios (SNRs) in which discrimination accuracy was high (i.e., 80-100%) and low SNRs producing discrimination performance at chance. EEG data were decomposed using independent component analysis and clustered across participants using principle component methods in EEGLAB. ICA revealed left and right sensorimotor µ components for 14/16 and 13/16 participants respectively that were identified on the basis of scalp topography, spectral peaks, and localization to the precentral and postcentral gyri. Time-frequency analysis of left and right lateralized µ component clusters revealed significant (pFDRspeech discrimination trials relative to chance trials following stimulus offset. Findings are consistent with constructivist, internal model theories proposing that early forward motor models generate predictions about likely phonemic units that are then synthesized with incoming sensory cues during active as opposed to passive processing. Future directions and possible translational value for clinical populations in which sensorimotor integration may play a functional role are discussed.

ChroPac-Trial: Duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial

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Schlitt Hans

2010-04-01

Full Text Available Abstract Background A recently published systematic review indicated superiority of duodenum-preserving techniques when compared with pancreatoduodenectomy, for the treatment of patients with chronic pancreatitis in the head of the gland. A multicentre randomised trial to confirm these results is needed. Methods/Design ChroPac aims to investigate differences in quality of life, mortality and morbidity during 24 months after surgery (duodenum-preserving pancreatic head resection versus pancreatoduodenectomy in patients with chronic pancreatitis of the pancreatic head. ChroPac is a randomised, controlled, observer and patient blinded multicentre surgical trial with two parallel comparison groups. The primary outcome measure will be the average quality of life during 24 months after surgery. Statistical analysis is based on the intention-to-treat population. Analysis of covariance will be applied for the intervention group comparison adjusting for age, centre and quality of life before surgery. Level of significance is set at 5% (two-sided and sample size (n = 100 per group is determined to assure a power of 90%. Discussion The ChroPac trial will explore important outcomes from different perspectives (e.g. surgeon, patient, health care system. Its pragmatic approach promises high external validity allowing a comprehensive evaluation of the surgical strategy for treatment of patients with chronic pancreatitis. Trial registration Controlled-trials.com ISRCTN38973832

Community-led trials: Intervention co-design in a cluster randomised controlled trial.

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Andersson, Neil

2017-05-30

In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control.Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies.A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a "male competence".Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the conventional wisdom about how

Community-led trials: Intervention co-design in a cluster randomised controlled trial

Directory of Open Access Journals (Sweden)

Neil Andersson

2017-05-01

Full Text Available Abstract In conventional randomised controlled trials (RCTs, researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control. Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies. A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a “male competence”. Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the

How to Evaluate Phase Differences between Trial Groups in Ongoing Electrophysiological Signals

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VanRullen, Rufin

2016-01-01

A growing number of studies endeavor to reveal periodicities in sensory and cognitive functions, by comparing the distribution of ongoing (pre-stimulus) oscillatory phases between two (or more) trial groups reflecting distinct experimental outcomes. A systematic relation between the phase of spontaneous electrophysiological signals, before a stimulus is even presented, and the eventual result of sensory or cognitive processing for that stimulus, would be indicative of an intrinsic periodicity in the underlying neural process. Prior studies of phase-dependent perception have used a variety of analytical methods to measure and evaluate phase differences, and there is currently no established standard practice in this field. The present report intends to remediate this need, by systematically comparing the statistical power of various measures of “phase opposition” between two trial groups, in a number of real and simulated experimental situations. Seven measures were evaluated: one parametric test (circular Watson-Williams test), and three distinct measures of phase opposition (phase bifurcation index, phase opposition sum, and phase opposition product) combined with two procedures for non-parametric statistical testing (permutation, or a combination of z-score and permutation). While these are obviously not the only existing or conceivable measures, they have all been used in recent studies. All tested methods performed adequately on a previously published dataset (Busch et al., 2009). On a variety of artificially constructed datasets, no single measure was found to surpass all others, but instead the suitability of each measure was contingent on several experimental factors: the time, frequency, and depth of oscillatory phase modulation; the absolute and relative amplitudes of post-stimulus event-related potentials for the two trial groups; the absolute and relative trial numbers for the two groups; and the number of permutations used for non-parametric testing

Geographic differences in heart failure trials.

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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.

Cross-Over Clinical Trials?

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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.

Clinical Development of a Cytomegalovirus DNA Vaccine: From Product Concept to Pivotal Phase 3 Trial

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Michele Gerber

2013-09-01

Full Text Available 2013 marks a milestone year for plasmid DNA vaccine development as a first-in-class cytomegalovirus (CMV DNA vaccine enters pivotal phase 3 testing. This vaccine consists of two plasmids expressing CMV antigens glycoprotein B (gB and phosphoprotein 65 (pp65 formulated with a CRL1005 poloxamer and benzalkonium chloride (BAK delivery system designed to enhance plasmid expression. The vaccine’s planned initial indication under investigation is for prevention of CMV reactivation in CMV-seropositive (CMV+ recipients of an allogeneic hematopoietic stem cell transplant (HCT. A randomized, double-blind placebo-controlled phase 2 proof-of-concept study provided initial evidence of the safety of this product in CMV+ HCT recipients who underwent immune ablation conditioning regimens. This study revealed a significant reduction in viral load endpoints and increased frequencies of pp65-specific interferon-γ-producing T cells in vaccine recipients compared to placebo recipients. The results of this endpoint-defining trial provided the basis for defining the primary and secondary endpoints of a global phase 3 trial in HCT recipients. A case study is presented here describing the development history of this vaccine from product concept to initiation of the phase 3 trial.

Clinical Development of a Cytomegalovirus DNA Vaccine: From Product Concept to Pivotal Phase 3 Trial.

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Smith, Larry R; Wloch, Mary K; Chaplin, Jennifer A; Gerber, Michele; Rolland, Alain P

2013-09-25

2013 marks a milestone year for plasmid DNA vaccine development as a first-in-class cytomegalovirus (CMV) DNA vaccine enters pivotal phase 3 testing. This vaccine consists of two plasmids expressing CMV antigens glycoprotein B (gB) and phosphoprotein 65 (pp65) formulated with a CRL1005 poloxamer and benzalkonium chloride (BAK) delivery system designed to enhance plasmid expression. The vaccine's planned initial indication under investigation is for prevention of CMV reactivation in CMV-seropositive (CMV⁺) recipients of an allogeneic hematopoietic stem cell transplant (HCT). A randomized, double-blind placebo-controlled phase 2 proof-of-concept study provided initial evidence of the safety of this product in CMV⁺ HCT recipients who underwent immune ablation conditioning regimens. This study revealed a significant reduction in viral load endpoints and increased frequencies of pp65-specific interferon-γ-producing T cells in vaccine recipients compared to placebo recipients. The results of this endpoint-defining trial provided the basis for defining the primary and secondary endpoints of a global phase 3 trial in HCT recipients. A case study is presented here describing the development history of this vaccine from product concept to initiation of the phase 3 trial.

Trial sponsorship and self-reported conflicts of interest in breast cancer radiation therapy: An analysis of prospective clinical trials.

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Leite, Elton T T; Moraes, Fabio Y; Marta, Gustavo N; Taunk, Neil K; Vieira, Marina T L; Hanna, Samir A; Silva, João Luis F; Carvalho, Heloisa A

2017-06-01

We aim to assess any association between study and self-reported conflict of interest (COI) or trial sponsorship in breast cancer radiation clinical trials. We searched PubMed for all clinical trials (CTs) published between 09/2004 and 09/2014 related to breast cancer. We included only radiotherapy CTs with primary clinical endpoints. We classified eligible trials according to the funding source, presence or absence of conflict of interest, study conclusion and impact factor (IF). 1,603 CTs were retrieved. 72 randomized clinical trials were included for analysis. For-profit (PO), not for profit organization (nPO), none and not reported sponsorship rates were 9/72 (12.5%), 35/72 (48.6%), 1/72 (1.4%), 27/72 (37.5%), respectively. Present, absent or not reported COI were found in 6/72 (8.3%), 43/72 (59.7%) and 23/72 (32%) of the CTs, respectively. Conclusion was positive, neutral and negative in 57/72 (79.1%), 9/72 (12.5%) and 6/72 (8.4%) of the trials, respectively. Positive conclusion was reported in 33/44 (75%) funded trials (PO and nPO) and 5/6 (83.3%) CTs with reported COI. On univariate analysis no association with funding source (P=0.178), COI (P=0.678) or trial region (P=0.567) and trial positive conclusion was found. Sponsored trials (HR 4.50, 95CI-0.1.23-16.53;P=0.0023) and positive trials (HR 4.78, 95CI- 1.16-19.63;P=0.030) were more likely to be published in higher impact factor journals in the multivariate analysis. nPO funding was reported in almost 50% of the evaluated CTs. No significant association between study conclusion and funding source, COI or trial region was identified. Sponsored trials and positive trials were more likely to be published in higher impact factor journals. Copyright © 2017 Elsevier Ltd. All rights reserved.

Do clinical trials conducted in India match its healthcare needs? An audit of the Clinical Trials Registry of India

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Mansi Chaturvedi

2017-01-01

Full Text Available Background: India continues to contribute disproportionately to the global burden of disease and public health research output from India is also known to be not commensurate with her healthcare needs. We carried out the present study to assess if clinical trials were in line with the health care needs of the country by auditing the clinical trials registry of India. Materials and Methods: All the clinical studies registered in CTRI between July 20, 2007 and December 31, 2015 were searched in the “Trial Search” section. The total number of studies, their phases of development, and therapeutic areas were assessed. Trials in each therapeutic area was compared with the disease burden (DALYs in that area taken from Global Health Estimates [2014] Summary Tables of the WHO. The number of trials conducted per state in India was also compared with the population of that state [Census 2011]. Results: A total of 6474 studies were registered of which 3325 (51.4% were clinical trials. The state of Maharashtra had the highest number trials [16.4%] followed by Karnataka ( 11.6% and Tamil Nadu (10%. Populous states like Uttar Pradesh (5.3% and Bihar (1.4% had far fewer trials. The largest number of trials was in the area of cancer (16.4%, followed by diabetes (12.1% and cardiovascular diseases (10.1%. Infectious and parasitic diseases had the highest DALYs (82,681 and ranked first in disease burden but accounted for only 5% of the total trials and ranked 7th according to number of trials. Cancer ranked first in the number of trials (16.4%, but ranked 6th based on DALYs. Conclusion: Clinical trials conducted in India are not in consonance with her health care needs. Strengthening the capacity for conducting trials in the populous states and the north-eastern part of the country is necessary to allow a more equitable selection of participants. The government should introduce policies to encourage new drug development in areas where needed the most.

Automated classification of eligibility criteria in clinical trials to facilitate patient-trial matching for specific patient populations.

Science.gov (United States)

Zhang, Kevin; Demner-Fushman, Dina

2017-07-01

To develop automated classification methods for eligibility criteria in ClinicalTrials.gov to facilitate patient-trial matching for specific populations such as persons living with HIV or pregnant women. We annotated 891 interventional cancer trials from ClinicalTrials.gov based on their eligibility for human immunodeficiency virus (HIV)-positive patients using their eligibility criteria. These annotations were used to develop classifiers based on regular expressions and machine learning (ML). After evaluating classification of cancer trials for eligibility of HIV-positive patients, we sought to evaluate the generalizability of our approach to more general diseases and conditions. We annotated the eligibility criteria for 1570 of the most recent interventional trials from ClinicalTrials.gov for HIV-positive and pregnancy eligibility, and the classifiers were retrained and reevaluated using these data. On the cancer-HIV dataset, the baseline regex model, the bag-of-words ML classifier, and the ML classifier with named entity recognition (NER) achieved macro-averaged F2 scores of 0.77, 0.87, and 0.87, respectively; the addition of NER did not result in a significant performance improvement. On the general dataset, ML + NER achieved macro-averaged F2 scores of 0.91 and 0.85 for HIV and pregnancy, respectively. The eligibility status of specific patient populations, such as persons living with HIV and pregnant women, for clinical trials is of interest to both patients and clinicians. We show that it is feasible to develop a high-performing, automated trial classification system for eligibility status that can be integrated into consumer-facing search engines as well as patient-trial matching systems. Published by Oxford University Press on behalf of the American Medical Informatics Association 2017. This work is written by US Government employees and is in the public domain in the US.

New approaches to trials in glomerulonephritis.

Science.gov (United States)

Craig, Jonathan C; Tong, Allison; Strippoli, Giovanni F M

2017-01-01

Randomized controlled trials are required to reliably identify interventions to improve the outcomes for people with glomerulonephritis (GN). Unfortunately, although easier, observational studies are inherently unreliable even though the findings of both study designs agree most of the time. Currently there are ∼790 trials in GN, but suboptimal design and reporting, together with small sample sizes, mean that they may not be reliable for decision making. If the history is somewhat bleak, the future looks bright, with recent initiatives to improve the quality, size and relevance of clinical trials in nephrology, including greater patient engagement, trial networks, core outcome sets, registry-based trials and adaptive designs. Given the current state of the evidence informing the care of people with GN, disruptive technologies and pervasive culture change is required to ensure that the potential of trials to improve the health of people with this complex condition is to be realized. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Internet trials: participant experiences and perspectives

Science.gov (United States)

2012-01-01

Background 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. Objective 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. Methods All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. Results 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

Internet trials: participant experiences and perspectives

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Mathieu Erin

2012-10-01

Full Text Available Abstract Background 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. Objective 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. Methods All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. Results 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

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,

[The epiglottis in antiquity in medicine and philosophy].

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Repici, L

1990-01-01

In Antiquity, the epiglottis and the related question whether drink enters the lung is a problem embracing both differently organized philosophical strategies and differently developed medical competences. Over the centuries, the history of a physiological question gradually turns into a debate where we find philosophers disagreeing with philosophers and physicians with physicians. A peculiar feature of this debate is that from a certain time on it involves a division between those who defend Plato's view on the subject and those who (philosophers as well as physicians) criticize it. Plato, Aristotle and Chrysippus, the Hippocratic authors and Erasistratus in the testimony of Aulus Gellius, Plutarch and indirectly also of Cicero, and then Galen and Macrobius have a special place in the development of this topic.

Terrorists on Trial: A Performative Perspective

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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.

Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey

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Houston Helen

2010-12-01

Full Text Available Abstract Background Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be fed back to research participants both for ethical research practice and for ensuring their co-operation in a trial. This study aims to determine participants' preferences for type of leaflet (short versus long used to summarise the findings of a randomised trial; and to test whether certain characteristics explained participants' preferences. Methods 553 participants in a randomised trial about General Practitioners' access to Magnetic Resonance Imaging for patients presenting with suspected internal derangement of the knee were asked in the final follow-up questionnaire whether they would like to be fed back the results of the trial. Participants who agreed to this were included in a postal questionnaire survey asking about their preference, if any, between a short and a long leaflet and what it was about the leaflet that they preferred. Multinomial logistic regression was used to test whether certain demographics of responding participants along with treatment group explained whether a participant had a preference for type of leaflet or no preference. Results Of the participants who returned the final follow-up questionnaire, 416 (88% agreed to receive the results of the trial. Subsequently 132 (32% participants responded to the survey. Most participants preferred the longer leaflet (55% and the main reasons for this were the use of technical information (94% and diagrams (89%. There was weak evidence to suggest that gender might explain whether participants have a preference for type of leaflet or not (P = 0.084. Conclusions Trial participants want to receive feed back about the results and appear to prefer a longer leaflet. Males and females might require information to be communicated to them differently and should

The optimal design of stepped wedge trials with equal allocation to sequences and a comparison to other trial designs.

Science.gov (United States)

Thompson, Jennifer A; Fielding, Katherine; Hargreaves, James; Copas, Andrew

2017-12-01

Background/Aims We sought to optimise the design of stepped wedge trials with an equal allocation of clusters to sequences and explored sample size comparisons with alternative trial designs. Methods We developed a new expression for the design effect for a stepped wedge trial, assuming that observations are equally correlated within clusters and an equal number of observations in each period between sequences switching to the intervention. We minimised the design effect with respect to (1) the fraction of observations before the first and after the final sequence switches (the periods with all clusters in the control or intervention condition, respectively) and (2) the number of sequences. We compared the design effect of this optimised stepped wedge trial to the design effects of a parallel cluster-randomised trial, a cluster-randomised trial with baseline observations, and a hybrid trial design (a mixture of cluster-randomised trial and stepped wedge trial) with the same total cluster size for all designs. Results We found that a stepped wedge trial with an equal allocation to sequences is optimised by obtaining all observations after the first sequence switches and before the final sequence switches to the intervention; this means that the first sequence remains in the control condition and the last sequence remains in the intervention condition for the duration of the trial. With this design, the optimal number of sequences is [Formula: see text], where [Formula: see text] is the cluster-mean correlation, [Formula: see text] is the intracluster correlation coefficient, and m is the total cluster size. The optimal number of sequences is small when the intracluster correlation coefficient and cluster size are small and large when the intracluster correlation coefficient or cluster size is large. A cluster-randomised trial remains more efficient than the optimised stepped wedge trial when the intracluster correlation coefficient or cluster size is small. A

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

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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.

Trial Courts in the Judicial Process.

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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)

Effect of Whey Supplementation on Circulating C-Reactive Protein: A Meta-Analysis of Randomized Controlled Trials

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Zhou, Ling-Mei; Xu, Jia-Ying; Rao, Chun-Ping; Han, Shufen; Wan, Zhongxiao; Qin, Li-Qiang

2015-01-01

Whey supplementation is beneficial for human health, possibly by reducing the circulating C-reactive protein (CRP) level, a sensitive marker of inflammation. Thus, a meta-analysis of randomized controlled trials was conducted to evaluate their relationship. A systematic literature search was conducted in July, 2014, to identify eligible studies. Either a fixed-effects model or a random-effects model was used to calculate pooled effects. The meta-analysis results of nine trials showed a slight, but no significant, reduction of 0.42 mg/L (95% CI −0.96, 0.13) in CRP level with the supplementation of whey protein and its derivates. Relatively high heterogeneity across studies was observed. Subgroup analyses showed that whey significantly lowered CRP by 0.72 mg/L (95% CI −0.97, −0.47) among trials with a daily whey dose ≥20 g/day and by 0.67 mg/L (95% CI −1.21, −0.14) among trials with baseline CRP ≥3 mg/L. Meta-regression analysis revealed that the baseline CRP level was a potential effect modifier of whey supplementation in reducing CRP. In conclusion, our meta-analysis did not find sufficient evidence that whey and its derivates elicited a beneficial effect in reducing circulating CRP. However, they may significantly reduce CRP among participants with highly supplemental doses or increased baseline CRP levels. PMID:25671415

Differences in Investigator-Initiated Trials between Japan and Other Countries: Analyses of Clinical Trials Sponsored by Academia and Government in the ClinicalTrials.gov Registry and in the Three Japanese Registries.

Directory of Open Access Journals (Sweden)

Tatsuya Ito

Full Text Available Following the amendment of the Pharmaceutical Affairs Law in Japan in 2003 researchers were permitted to begin investigator-initiated trials (IITs. In subsequent years, however, the number of IITs remained low. In other countries in Asia as well as in Europe, North America, and South Africa, the number of IITs has increased over the past decade. The differences in the characteristics of IITs between Japan and other countries are unknown. Some studies have analyzed the characteristics of all clinical trials according to registry databases, but there has been less research focusing on IITs.The purpose of this study is to analyze the characteristics of IITs in the ClinicalTrials.gov registry and in the three Japanese registries, to identify differences in IITs between Japan and other countries.Using Thomson Reuters Pharma™, trials sponsored by academia and government as IITs in 2010 and registered in ClinicalTrials.gov were identified. IITs from 2004 to 2012 in Japan were identified in the three Japanese registries: the University Hospital Medical Information Network Clinical Trials Registry, the Japan Pharmaceutical Information Center Clinical Trials Information, and the Japan Medical Association Center for Clinical Trials, Clinical Trials Registry. Characterization was made of the trial purposes, phases, participants, masking, arms, design, controls, and other data.New and revised IITs registered in ClinicalTrials.gov during 2010 averaged about 40% of all sponsor-identified trials. IITs were nearly all early-phase studies with small numbers of participants. A total of 56 Japanese IITs were found over a period of 8 years, and these were also almost nearly all early-phase studies with small numbers of participants.There appear to be no great differences between Japan and other countries in terms of characteristics of IITs. These results should prompt a new review of the IIT environment in Japan.

A pilot feeding study for adults with asthma: The healthy eating better breathing trial.

Directory of Open Access Journals (Sweden)

Emily P Brigham

Full Text Available Evidence from observational studies and to a lesser extent clinical trials suggest that a healthy diet may improve symptoms and lung function in patients with asthma. We conducted a pilot study to determine the feasibility of conducting a larger scale dietary trial and to provide preliminary evidence on the impact of a healthy diet on asthma outcomes.In a randomized, two period cross-over trial, participants with asthma received a 4-week dietary intervention followed by a usual diet (or vice versa, separated by a 4-week washout. The dietary intervention was a healthy diet rich in unsaturated fat. During the dietary intervention, participants ate three meals per week on site at the Johns Hopkins ProHealth Research Center. All remaining meals and snacks were provided for participants to consume off-site. During the control diet, participants were instructed to continue their usual dietary intake. Relevant biomarkers and asthma clinical outcomes were assessed at 0, 2, and 4 weeks after starting each arm of the study.Eleven participants were randomized, and seven completed the full study protocol. Among these seven participants, average age was 42 years, six were female, and six were African American. Participant self-report of dietary intake revealed significant increases in fruit, vegetable, and omega-3 fatty acid intake with the dietary intervention compared to usual diet. Serum carotenoids (eg. lutein and beta-cryptoxanthin increased in the intervention versus control. Total cholesterol decreased in the intervention versus control diet. There was no consistent effect on asthma outcomes.The findings suggest that a feeding trial in participants with asthma is feasible. Larger trials are needed to definitively assess the potential benefits of dietary interventions on pulmonary symptoms and function in patients with asthma.

Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years

DEFF Research Database (Denmark)

Gluud, Christian; Nikolova, Dimitrinka

2007-01-01

The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study.......The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study....

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: protocol for a feasibility randomized pilot trial.

Science.gov (United States)

Johnstone, Jennie; Meade, Maureen; Marshall, John; Heyland, Daren K; Surette, Michael G; Bowdish, Dawn Me; Lauzier, Francois; Thebane, Lehana; Cook, Deborah J

2015-01-01

Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 10 10 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

Science.gov (United States)

Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

2015-01-01

Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

Directory of Open Access Journals (Sweden)

Marleine Azar

Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is