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Sample records for well-known arginusai trial

  1. A proposition well known to geometers

    Science.gov (United States)

    Erlichson, Herman

    2001-03-01

    This note describes laboratory experiment ?13 in the liberal arts physics course Galileo to Newton and Beyond. The title of these experiment is Newton's Collision Experiments with Pendulums. Newton described these experiments in his Principia (pp. 22-25). He used these experiments to provide experimental confirmation for his action-reaction law. The note focuses on a mathematical proposition which was well known to geometers at the time of Newton, that "the velocity of a pendulum body in the lowest point is as the chord of the arc which it has described in its descent."

  2. Bottom-up effects modulate saccadic latencies in well-known eye movement paradigm.

    Science.gov (United States)

    van Stockum, Saskia; Macaskill, Michael R; Anderson, Tim J

    2011-07-01

    A well-known eye movement paradigm combines saccades (fast eye movements) with a perceptual discrimination task. At a variable time after the onset of a central arrow cue indicating the target direction [the stimulus onset asynchrony (SOA)], discrimination symbols appear briefly at saccade target and non-target locations. A previous study revealed an unexpected effect of SOA on saccadic latencies: latencies were longer in trials with longer SOAs. It was suggested that this effect reflects a top-down process as observers may wait for the discrimination symbol to appear before executing saccades. However, symbol onsets may also modulate saccade latencies from the bottom-up. To clarify the origin of the SOA effect on latencies in this paradigm, we used a simplified version of the original task plus two new symbol onset conditions for comparison. The results indicate that the modulation of saccadic latencies was not due to a top-down strategy, but to a combination of two opposing bottom-up effects: the symbol onsets at the target location shortened saccade latencies, while symbol onsets at non-target locations lengthened saccade latencies. PMID:20730444

  3. A well known and important adverse effect of phenytoin in a neurosurgical patient.

    Science.gov (United States)

    Tomar, Gaurav Singh; Saxena, Anudeep; Kumar, Niraj; Goyal, Keshav

    2015-01-01

    Gum hypertrophy is a well-known and important adverse effect of phenytoin therapy in a neurosurgical patient. We present an interesting case of a 21-year-old man who, following head injury after a road traffic accident, developed status epilepticus diagnosed with gum hypertrophy in the jaws, with ongoing antiepileptics. He was managed conservatively as per hospital protocol. PMID:26475882

  4. ORGANIZATIONAL CAPABILITIES FOR STRATEGIC LEADERSHIP IN WELL-KNOWN LOGISTICS COMPANIES IN FINLAND

    OpenAIRE

    Urb, Liina

    2011-01-01

    This study focuses on organizational capabilities for strategic leadership in logistics companies in today’s hectic and dynamic business environment. The main aim of the thesis is to understand and to explore the logistics companies use organizational capabilities for strategic leadership and how they react to the changes. The mini-survey was made by analyzing seven well-known logistics companies in Finland. Organizational capabilities include formulating strategies, learning process, pla...

  5. An investigation on consumer’s behaviors towards well-known luxury brands

    OpenAIRE

    Mohammad Javad Ghasemi

    2014-01-01

    This paper presents an empirical investigation to find the relationship between consumer’s behaviors towards well-known luxury brands in Iranian market. The study designs a questionnaire in Likert scale and distributes it among 250 randomly people who purchase luxury products. The study investigates the effects of three variables including perception value, social normality and need for being exclusive on perception of a brand for motivating customers to purchase luxury products. In addition,...

  6. On Relationship between the Boston Bound and Well-Known Bounds for Cyclic Codes

    Science.gov (United States)

    Zheng, Junru; Kaida, Takayasu

    For a cyclic code, the BCH Bound and the Hartmann-Tzeng bound are two of well-known lower bounds for its minimum distance. New bounds are proposed by N. Boston in 2001, that depend on defining set of cyclic code. In this paper, we consider the between the Boston bound and these two bounds for non-binary cyclic codes from numerical examples.

  7. Qualitative understanding of the Lorenz equations through a well-known second order dynamical system

    Science.gov (United States)

    Miari, Massimo

    1986-09-01

    In the present paper we show how it is possible to reduce the Lorenz system, modeling the onset of turbulence in the Bénard problem, to a well-known dynamical system on a two-dimensional manifold. The reduction is made by applying in a skillful way the center manifold theory. In such a way one obtains a syntetic qualitative description of some relevant aspects of the phase portraits and of the bifurcations in the original system.

  8. ORGANIZATIONAL CAPABILITIES FOR STRATEGIC LEADERSHIP IN WELL-KNOWN LOGISTICS COMPANIES IN FINLAND

    OpenAIRE

    Urb, Liina

    2011-01-01

    This study focuses on organizational capabilities for strategic leadership in logistics companies in today’s hectic and dynamic business environment. The main aim of the thesis is to understand and to explore the logistics companies use organizational capabilities for strategic leadership and how they react to the changes. The mini-survey was made by analyzing seven well-known logistics companies in Finland. Organizational capabilities include formulating strategies, learning process, pla...

  9. An investigation on consumer’s behaviors towards well-known luxury brands

    Directory of Open Access Journals (Sweden)

    Mohammad Javad Ghasemi

    2014-03-01

    Full Text Available This paper presents an empirical investigation to find the relationship between consumer’s behaviors towards well-known luxury brands in Iranian market. The study designs a questionnaire in Likert scale and distributes it among 250 randomly people who purchase luxury products. The study investigates the effects of three variables including perception value, social normality and need for being exclusive on perception of a brand for motivating customers to purchase luxury products. In addition, the study tries to find out whether customers’ educational backgrounds influence on purchasing luxury products or not. Cronbach alphas are all well above the minimum acceptable level, which validates the survey. Using structural equation modeling, the study confirms all hypotheses of the survey.

  10. Structural, electronic and optical properties of well-known primary explosive: Mercury fulminate.

    Science.gov (United States)

    Yedukondalu, N; Vaitheeswaran, G

    2015-11-28

    Mercury Fulminate (MF) is one of the well-known primary explosives since 17th century and it has rendered invaluable service over many years. However, the correct molecular and crystal structures are determined recently after 300 years of its discovery. In the present study, we report pressure dependent structural, elastic, electronic and optical properties of MF. Non-local correction methods have been employed to capture the weak van der Waals interactions in layered and molecular energetic MF. Among the non-local correction methods tested, optB88-vdW method works well for the investigated compound. The obtained equilibrium bulk modulus reveals that MF is softer than the well known primary explosives Silver Fulminate (SF), silver azide and lead azide. MF exhibits anisotropic compressibility (b > a > c) under pressure, consequently the corresponding elastic moduli decrease in the following order: C22 > C11 > C33. The structural and mechanical properties suggest that MF is more sensitive to detonate along c-axis (similar to RDX) due to high compressibility of Hg⋯O non-bonded interactions along that axis. Electronic structure and optical properties were calculated including spin-orbit (SO) interactions using full potential linearized augmented plane wave method within recently developed Tran-Blaha modified Becke-Johnson (TB-mBJ) potential. The calculated TB-mBJ electronic structures of SF and MF show that these compounds are indirect bandgap insulators. Also, SO coupling is found to be more pronounced for 4d and 5d-states of Ag and Hg atoms of SF and MF, respectively. Partial density of states and electron charge density maps were used to describe the nature of chemical bonding. Ag-C bond is more directional than Hg-C bond which makes SF to be more unstable than MF. The effect of SO coupling on optical properties has also been studied and found to be significant for both (SF and MF) of the compounds. PMID:26627968

  11. Structural, electronic and optical properties of well-known primary explosive: Mercury fulminate

    Science.gov (United States)

    Yedukondalu, N.; Vaitheeswaran, G.

    2015-11-01

    Mercury Fulminate (MF) is one of the well-known primary explosives since 17th century and it has rendered invaluable service over many years. However, the correct molecular and crystal structures are determined recently after 300 years of its discovery. In the present study, we report pressure dependent structural, elastic, electronic and optical properties of MF. Non-local correction methods have been employed to capture the weak van der Waals interactions in layered and molecular energetic MF. Among the non-local correction methods tested, optB88-vdW method works well for the investigated compound. The obtained equilibrium bulk modulus reveals that MF is softer than the well known primary explosives Silver Fulminate (SF), silver azide and lead azide. MF exhibits anisotropic compressibility (b > a > c) under pressure, consequently the corresponding elastic moduli decrease in the following order: C22 > C11 > C33. The structural and mechanical properties suggest that MF is more sensitive to detonate along c-axis (similar to RDX) due to high compressibility of Hg⋯O non-bonded interactions along that axis. Electronic structure and optical properties were calculated including spin-orbit (SO) interactions using full potential linearized augmented plane wave method within recently developed Tran-Blaha modified Becke-Johnson (TB-mBJ) potential. The calculated TB-mBJ electronic structures of SF and MF show that these compounds are indirect bandgap insulators. Also, SO coupling is found to be more pronounced for 4d and 5d-states of Ag and Hg atoms of SF and MF, respectively. Partial density of states and electron charge density maps were used to describe the nature of chemical bonding. Ag—C bond is more directional than Hg—C bond which makes SF to be more unstable than MF. The effect of SO coupling on optical properties has also been studied and found to be significant for both (SF and MF) of the compounds.

  12. Eco-friendly methodologies for the synthesis of some aromatic esters, well-known cosmetic ingredients.

    Science.gov (United States)

    Villa, C; Baldassari, S; Gambaro, R; Mariani, E; Loupy, A

    2005-02-01

    Solid-liquid solvent-free phase transfer catalysis (PTC) and acidic catalysis in dry media were applied, with noticeable improvement and simplification over classical procedures in a Green Chemistry context, to the synthesis of some aromatic esters useful as cosmetic ingredients: 3-methylbutyl 4-methoxycinnamate, 2-ethylhexyl 4-methoxycinnamate, 2-ethylhexyl 4-(dimethylamino)benzoate and 2-ethylhexyl salicylate, well-known ultraviolet B sunscreen filters; 4-isopropylbenzyl salicylate, UV absorber and cutaneous antilipoperoxidant; propyl 4-hydroxybenzoate and butyl 4-hydroxybenzoate (parabens), antimicrobial agents. The reactions were performed under microwave (MW) activation and conventional heating. The best results for the synthesis of cinnamic, salicylic and 4-(dimethylamino)benzoic esters were achieved by in situ preformed carboxylates alkylation with alkyl bromides using PTC. The 4-hydroxybenzoates were obtained in good yields by classical esterification of the acid with alcohols using a simple heterogeneous mixture of reagents with catalytic amounts of p-toluenesulfonic acid (PTSA). The comparisons of yields and thermal profiles under either MW or conventional heating were studied and reported. PMID:18492177

  13. Time course of EEG oscillations during repeated listening of a well-known aria

    Directory of Open Access Journals (Sweden)

    Lutz Jäncke

    2015-07-01

    Full Text Available While previous studies have analyzed mean neurophysiological responses to musical stimuli, the current study aimed to identify specific time courses of EEG oscillations, which are associated with dynamic changes in the acoustic features of the musical stimulus. In addition, we were interested in whether these time courses change during a repeated presentation of the same musical piece. A total of 16 subjects repeatedly listened to the well-known aria “Nessun dorma,” sung by Paul Potts, while continuous 128-channel EEG and heart rate (HR, as well as electrodermal (EDA responses, were recorded. The time courses for the EEG oscillations were calculated using a time resolution of 1 second for several frequency bands, on the basis of individual alpha-peak frequencies (theta, low alpha-1, low alpha-2, upper alpha, and beta. For all frequency bands, we identified a more or less continuous increase in power relative to a baseline period, indicating strong event-related synchronization (ERS during music listening. The ERS time courses, however, did not correlate strongly with the time courses of the acoustic features of the aria. In addition, we did not observe changes in EEG oscillations after repeated presentation of the same musical piece. Aside from this distinctive feature, we identified a remarkable variability in EEG oscillations, both within and between the repeated presentations of the aria. We interpret the continuous increase in ERS observed in all frequency bands during music listening as an indicator of a particular neurophysiological and psychological state evoked by music listening. We suggest that this state is characterized by increased internal attention (accompanied by reduced external attention, increased inhibition of brain networks not involved in the generation of this internal state, the maintenance of a particular level of general alertness, and a type of brain state that can be described as “mind wandering.” The overall state can be categorize

  14. Well-known trademark protection. A comparative study between the laws of the European Union and Vietnam

    OpenAIRE

    Phan Ngoc, Tam

    2011-01-01

    Well-known trademarks have been recognized as one of the most important types of trademark in the trademark system as reflected in both national law and in international treaties. The legal regime of well-known trademark protection has been continuously enhanced and developed over time due to the increasing importance of well-known trademarks becoming known to a worldwide public as well as development of their role in the international trade system. However, these legal issues are novel conce...

  15. The paraplegic Viking and the one-armed pianist--some well known persons with locomotor disability.

    Science.gov (United States)

    Stensman, R

    1983-01-01

    A review is given of persons from history, culture and science, with locomotor disability, who by different reasons have become well known. It is shown that these persons, in spite of their disabilities, have reached prominent positions. PMID:6232700

  16. Cystone, a well-known herbal formulation, inhibits struvite crystal growth formation in single diffusion gel growth technique

    Directory of Open Access Journals (Sweden)

    Pralhad S. Patki

    2013-02-01

    Full Text Available Objective: The present study was aimed to evaluate the beneficial effect of Cystone® against struvite crystal growth in in vitro conditions. Methods: Various concentrations of Cystone® was prepared in 1 M magnesium acetate solution and evaluated for crystal growth inhibition assay by a well-known method called single diffusion gel growth technique in vitro. Results: Cystone®, a well-known polyherbal formulation, at 0.5, 1 and 2% concentrations showed significant and dose-dependent inhibition of struvite crystal growth formation in in vitro by reducing number, total mass and total volume of the struvite crystals formed and also caused fragmentation of grown struvite crystals in the gel matrix. Conclusion: The results of the present study indicate, Cystone® significantly retards the formation of struvite stones and also brings about its fragmentation. This could be one of the probable mechanisms behind the beneficial effect offered by Cystone® in the clinical management of urolithiasis and urinary tract infections. [J Exp Integr Med 2013; 3(1: 51-55

  17. Defect of the well-known (classical) expression for the ionization rate in gas-discharge plasma and its modification

    Science.gov (United States)

    Litvinov, I. I.

    2015-11-01

    A critical analysis is given of the well-known expression for the electron-impact ionization rate constant ? i of neutral atoms and ions, derived by linearization of the ionization cross section ? i (?) as a function of the electron energy near the threshold I and containing the characteristic factor ( I + 2 kT). Using the classical Thomson expression for the ionization cross section, it is shown that in addition to the linear slope of ? i (?), it is also necessary to take into account the large negative curvature of this function near the threshold. In this case, the second term in parentheses changes its sign, which means that the commonly used expression for ? i (˜4 kT/I) already at moderate values of the temperature ( kT/I ˜ 0.1). The source of this error lies in a mathematical mistake in the original approach and is related to the incorrect choice of the sequential orders of terms small in the parameter kT/I. On the basis of a large amount of experimental data and considerations similar to the Gryzinski theory, a universal two-parameter modification of the Thomson formula (as well as the Bethe—Born formula) is proposed and a new simple expression for the ionization rate constant for arbitrary values of kT/I is derived.

  18. Monophyly or polyphyly? Possible conflict between morphological and molecular interpretations of the well-known genus Zoothamnium (Ciliophora, Peritrichia)

    Science.gov (United States)

    Li, Lifang; Ma, Honggang; Al-Rasheid, Khaled A. S.

    2015-03-01

    In this paper, we explore possible conflict between morphological and molecular interpretations of phylogenetic relationships within the well-known peritrichous genus Zoothamnium. On the basis of morphological evidence, for a long time this genus has been believed to be a well-defined monophyletic taxon. Nonetheless, Zoothamnium exhibits higher genetic diversity than the gross morphology of its species. Here, we used all available genetic information for the small subunit of ribosomal RNA (SSU rRNA) and internal transcribed spacer region (ITS1-5.8S-ITS2) for this genus to reconstruct phylogenies for four datasets (SSU rRNA, ITS1, ITS2, and ITS1-5.8S-ITS2) and a combined dataset (SSU rRNA+ITS1-5.8SITS2) using different phylogenetic methods and with consideration of the secondary structure of the genes. Confidence in phylogenetic tree selection was assessed with the approximately unbiased test. The molecular results showed both that Zoothamnium is more likely to be polyphyletic, and morphologically similar genera Zoothamnopsis and Myoschiston were always nested among Zoothamnium species. Accordingly, as with some other groups of ciliates, to understand more fully the correct phylogeny of Zoothamnium there remains a need for additional data from both morphological and molecular studies, covering additional Zoothamnium spp. and members of closely related genera (e.g. Zoothamnopsis, Myoschiston, and Epistylis).

  19. Extensive gaps and biases in our knowledge of a well-known fauna: Implications for integrating biological traits into macroecology

    KAUST Repository

    Tyler, Elizabeth

    2011-12-09

    Aim Ecologists seeking to describe patterns at ever larger scales require compilations of data on the global abundance and distribution of species. Comparable compilations of biological data are needed to elucidate the mechanisms behind these patterns, but have received far less attention. We assess the availability of biological data across an entire assemblage: the well-documented demersal marine fauna of the United Kingdom. We also test whether data availability for a species depends on its taxonomic group, maximum body size, the number of times it has been recorded in a global biogeographic database, or its commercial and conservation importance. Location Seas of the United Kingdom. Methods We defined a demersal marine fauna of 973 species from 15 phyla and 40 classes using five extensive surveys around the British Isles. We then quantified the availability of data on eight key biological traits (termed biological knowledge) for each species from online databases. Relationships between biological knowledge and our predictors were tested with generalized linear models. Results Full data on eight fundamental biological traits exist for only 9% (n= 88) of the UK demersal marine fauna, and 20% of species completely lack data. Clear trends in our knowledge exist: fish (median biological knowledge score = six traits) are much better known than invertebrates (one trait). Biological knowledge increases with biogeographic knowledge and (to a lesser extent) with body size, and is greater in species that are commercially exploited or of conservation concern. Main conclusions Our analysis reveals deep ignorance of the basic biology of a well-studied fauna, highlighting the need for far greater efforts to compile biological trait data. Clear biases in our knowledge, relating to how well sampled or \\'important\\' species are suggests that caution is required in extrapolating small subsets of biologically well-known species to ecosystem-level studies. © 2011 Blackwell Publishing Ltd.

  20. Well-known surface and extracellular antigens of pathogenic microorganisms among the immunodominant proteins of the infectious microalgae Prototheca zopfii

    Science.gov (United States)

    Irrgang, Alexandra; Murugaiyan, Jayaseelan; Weise, Christoph; Azab, Walid; Roesler, Uwe

    2015-01-01

    Microalgae of the genus Prototheca (P.) are associated with rare but severe infections (protothecosis) and represent a potential zoonotic risk. Genotype (GT) 2 of P. zopfii has been established as pathogenic agent for humans, dogs, and cattle, whereas GT1 is considered to be non-pathogenic. Since pathogenesis is poorly understood, the aim of this study was to determine immunogenic proteins and potential virulence factors of P. zopfii GT2. Therefore, 2D western blot analyses with sera and isolates of two dogs naturally infected with P. zopfii GT2 have been performed. Cross-reactivity was determined by including the type strains of P. zopfii GT2, P. zopfii GT1, and P. blaschkeae, a close relative of P. zopfii, which is known to cause subclinical forms of bovine mastitis. The sera showed a high strain-, genotype-, and species-cross-reactivity. A total of 198 immunogenic proteins have been analyzed via MALDI—TOF MS. The majority of the 86 identified proteins are intracellularly located (e.g., malate dehydrogenase, oxidoreductase, 3-dehydroquinate synthase) but some antigens and potential virulence factors, known from other pathogens, have been found (e.g., phosphomannomutase, triosephosphate isomerase). One genotype-specific antigen could be identified as heat shock protein 70 (Hsp70), a well-known antigen of eukaryotic pathogens with immunological importance when located extracellularly. Both sera were reactive to glyceraldehyde-3-phosphate-dehydrogenase of all investigated strains. This house-keeping enzyme is found to be located on the surface of several pathogens as virulence factor. Flow-cytometric analysis revealed its presence on the surface of P. blaschkeae. PMID:26484314

  1. Well-known surface and extracellular antigens of pathogenic microorganisms among the immunodominant proteins of the infectious microalgae Prototheca zopfii.

    Science.gov (United States)

    Irrgang, Alexandra; Murugaiyan, Jayaseelan; Weise, Christoph; Azab, Walid; Roesler, Uwe

    2015-01-01

    Microalgae of the genus Prototheca (P.) are associated with rare but severe infections (protothecosis) and represent a potential zoonotic risk. Genotype (GT) 2 of P. zopfii has been established as pathogenic agent for humans, dogs, and cattle, whereas GT1 is considered to be non-pathogenic. Since pathogenesis is poorly understood, the aim of this study was to determine immunogenic proteins and potential virulence factors of P. zopfii GT2. Therefore, 2D western blot analyses with sera and isolates of two dogs naturally infected with P. zopfii GT2 have been performed. Cross-reactivity was determined by including the type strains of P. zopfii GT2, P. zopfii GT1, and P. blaschkeae, a close relative of P. zopfii, which is known to cause subclinical forms of bovine mastitis. The sera showed a high strain-, genotype-, and species-cross-reactivity. A total of 198 immunogenic proteins have been analyzed via MALDI-TOF MS. The majority of the 86 identified proteins are intracellularly located (e.g., malate dehydrogenase, oxidoreductase, 3-dehydroquinate synthase) but some antigens and potential virulence factors, known from other pathogens, have been found (e.g., phosphomannomutase, triosephosphate isomerase). One genotype-specific antigen could be identified as heat shock protein 70 (Hsp70), a well-known antigen of eukaryotic pathogens with immunological importance when located extracellularly. Both sera were reactive to glyceraldehyde-3-phosphate-dehydrogenase of all investigated strains. This house-keeping enzyme is found to be located on the surface of several pathogens as virulence factor. Flow-cytometric analysis revealed its presence on the surface of P. blaschkeae. PMID:26484314

  2. IgG4-related Hashimoto’s thyroiditis – A new variant of a well known disease

    Directory of Open Access Journals (Sweden)

    Henrique Vara Luiz

    2014-11-01

    Full Text Available Hashimoto’s thyroiditis (HT has been characterized for many years as a well-defined clinicopathologic entity, but is now considered a heterogeneous disease. IgG4-related HT is a new subtype characterized by thyroid inflammation rich in IgG4-positive plasma cells and marked fibrosis. It may be part of the systemic IgG4-related disease. We report a case of a 56-year-old Portuguese man who presented with a one-month history of progressive neck swelling and dysphagia. Laboratory testing revealed increased inflammatory parameters, subclinical hypothyroidism and very high levels of thyroid autoantibodies. Cervical ultrasound (US demonstrated an enlarged and heterogeneous thyroid gland and two hypoechoic nodules. US-guided fine needle aspiration cytology was consistent with lymphocytic thyroiditis. The patient was submitted to total thyroidectomy and microscopic examination identified typical findings of HT, marked fibrosis limited within the thyroid capsule and lymphoplasmacytic infiltration, with >50 IgG4-positive plasma cells per high-power field and an IgG4/IgG ratio of >40%. After surgery, serum IgG4 concentration was high-normal. Symptoms relief and reduction in laboratory inflammatory parameters were noticed. Thyroid function is controlled with levothyroxine. To our knowledge we report the first case of IgG4-related HT in a non-Asian patient. We also perform a review of the literature regarding IgG4-related disease and IgG4-related HT. Our case highlights this new variant of the well known HT, and helps physicians in recognizing its main clinical features, allowing for proper diagnosis and treatment.

  3. Síndrome de Rett: 50 años de historia de un trastorno aun no bien conocido / Rett syndrome: 50 years' history of a still not well known condition

    Scientific Electronic Library Online (English)

    Jaime, Campos-Castello; Daniel M., Fernandez-Mayoralas; Nuria, Muñoz-Jareño; Victoria, San Antonio-Arce.

    Full Text Available Desde que fue descrito por primera vez por Andreas Rett hace 50 años, el síndrome de Rett (SR) ha sido objeto de muchas investigaciones, sin embargo continúa siendo un trastorno aún no bien conocido. Presentamos nuestra propia experiencia y una revisión de la literatura sobre el SR. Se trata de un t [...] rastorno del neurodesarrollo, dominante ligado a X, que afecta casi siempre a mujeres, la mayoría de los casos de forma esporádica. El diagnóstico de SR debe hacerse en base a la observación clínica. Las principales características son la aparición de un retraso mental, cambios conductuales, estereotipias, pérdida del lenguaje y, sobre todo, del uso propositivo de las manos, aparición de una apraxia de la marcha, presencia de alteraciones de la respiración y, frecuentemente, crisis epilépticas. Los criterios diagnósticos consensuados internacionalmente son aquí revisados. El SR se debe en la mayoría de casos a mutaciones del gen MECP2, si bien una proporción de casos atípicos puede estar causada por mutaciones de CDKL5, particularmente la variante con epilepsia precoz. Sin embargo, los mecanismos patogénicos moleculares no son bien conocidos, así como la relación entre las mutaciones de MECP2 y otros trastornos del desarrollo. Revisamos también los hallazgos de neuroimagen, neuropatológicos y neurobioquímicos descritos en el SR. Respecto al tratamiento, aparte del sintomático, no hay ninguno que se haya mostrado eficaz. Un trabajo reciente abre perspectivas terapéuticas futuras al haber demostrado mediante un modelo animal de ratón la reversión de los síntomas neurológicos mediante la activación de la expresión de MeCP2. Abstract in english Since it was first described by Andrea Rett 50 years ago, Rett syndrome (RS) has been the subject of further investigations, nonetheless it continues to be a not well known condition. Our own experience and an updated literature review on RS is presented. RS is a severe dominant X chromosome-linked [...] neurodevelopmental disorder with a characteristic clinical picture that mostly occurs in girls, most of the cases are sporadic and genetically determined. The diagnosis of RS is made based on observation and clinical assessment. Main clinical features are mental retardation, behavioural changes, stereotypes, loss of speech and hand skills, gait apraxia, irregular breathing with hyperventilation while awake, and frequent seizures. The internationally established criteria are reviewed. RS is caused by mutations in MECP2 in the majority of cases, but a proportion of atypical cases may result from mutations in CDKL5, particularly the early onset seizure variant. However, the molecular pathogenesis of this disorder remains unclear, as well as the relation between the mutations in MECP2 and other neurodevelopmental disorders. Neuroimaging, neuropathological and biochemical findings in RS are reviewed. Besides symptomatic treatment, no therapeutic trials have shown effectiveness. Some perspectives in the treatment of RS have been provided by a recent work showing a phenotypic reversal by activation of MeCP2 expression in a mouse model.

  4. Síndrome de Rett: 50 años de historia de un trastorno aun no bien conocido Rett syndrome: 50 years' history of a still not well known condition

    Directory of Open Access Journals (Sweden)

    Jaime Campos-Castello

    2007-01-01

    Full Text Available Desde que fue descrito por primera vez por Andreas Rett hace 50 años, el síndrome de Rett (SR ha sido objeto de muchas investigaciones, sin embargo continúa siendo un trastorno aún no bien conocido. Presentamos nuestra propia experiencia y una revisión de la literatura sobre el SR. Se trata de un trastorno del neurodesarrollo, dominante ligado a X, que afecta casi siempre a mujeres, la mayoría de los casos de forma esporádica. El diagnóstico de SR debe hacerse en base a la observación clínica. Las principales características son la aparición de un retraso mental, cambios conductuales, estereotipias, pérdida del lenguaje y, sobre todo, del uso propositivo de las manos, aparición de una apraxia de la marcha, presencia de alteraciones de la respiración y, frecuentemente, crisis epilépticas. Los criterios diagnósticos consensuados internacionalmente son aquí revisados. El SR se debe en la mayoría de casos a mutaciones del gen MECP2, si bien una proporción de casos atípicos puede estar causada por mutaciones de CDKL5, particularmente la variante con epilepsia precoz. Sin embargo, los mecanismos patogénicos moleculares no son bien conocidos, así como la relación entre las mutaciones de MECP2 y otros trastornos del desarrollo. Revisamos también los hallazgos de neuroimagen, neuropatológicos y neurobioquímicos descritos en el SR. Respecto al tratamiento, aparte del sintomático, no hay ninguno que se haya mostrado eficaz. Un trabajo reciente abre perspectivas terapéuticas futuras al haber demostrado mediante un modelo animal de ratón la reversión de los síntomas neurológicos mediante la activación de la expresión de MeCP2.Since it was first described by Andrea Rett 50 years ago, Rett syndrome (RS has been the subject of further investigations, nonetheless it continues to be a not well known condition. Our own experience and an updated literature review on RS is presented. RS is a severe dominant X chromosome-linked neurodevelopmental disorder with a characteristic clinical picture that mostly occurs in girls, most of the cases are sporadic and genetically determined. The diagnosis of RS is made based on observation and clinical assessment. Main clinical features are mental retardation, behavioural changes, stereotypes, loss of speech and hand skills, gait apraxia, irregular breathing with hyperventilation while awake, and frequent seizures. The internationally established criteria are reviewed. RS is caused by mutations in MECP2 in the majority of cases, but a proportion of atypical cases may result from mutations in CDKL5, particularly the early onset seizure variant. However, the molecular pathogenesis of this disorder remains unclear, as well as the relation between the mutations in MECP2 and other neurodevelopmental disorders. Neuroimaging, neuropathological and biochemical findings in RS are reviewed. Besides symptomatic treatment, no therapeutic trials have shown effectiveness. Some perspectives in the treatment of RS have been provided by a recent work showing a phenotypic reversal by activation of MeCP2 expression in a mouse model.

  5. Health status of adults with Short Stature: A comparison with the normal population and one well-known chronic disease (Rheumatoid Arthritis)

    OpenAIRE

    Naess Eva E; Andresen Inger-Lise; Johansen Heidi; Hagen Kare

    2007-01-01

    Abstract Background To examine the subjective health status of adults with short stature (ShSt) and compare with the general population (GP) and one well-known chronic disease, rheumatoid artritis (RA). In addition, to explore the association between age, gender, height, educational level and different aspects of health status of adults with short stature. Methods A questionnaire was mailed to 72 subjects with short stature registered in the database of a Norwegian resource centre for rare di...

  6. Predicting hourly solar irradiations on inclined surfaces based on the horizontal measurements: Performances of the association of well-known mathematical models

    International Nuclear Information System (INIS)

    In a lot of sites, at best, only global irradiations on horizontal planes are available. As most systems using solar energy are tilted, it is obvious that these data are not sufficient. The purpose of our work consists in predicting the solar irradiation on inclined surfaces based on horizontal measurements. To reach this goal, two previous studies were performed. They consisted in quantifying the accuracy of various well-known models of the literature: the first type of models (seven correlations) calculated diffuse horizontal irradiations from global ones and the second type (fifteen models) computed global irradiations on inclined planes from diffuse and global components on a horizontal surface. This study combines the two classes of models and calculates the adequacy of each association for experimental hourly data collected on the French Mediterranean site of Ajaccio. We compared these combinations with the Olmo model, transforming global irradiations directly onto tilted planes from horizontal ones

  7. Type 2 diabetes and metformin. First choice for monotherapy: weak evidence of efficacy but well-known and acceptable adverse effects.

    Science.gov (United States)

    2014-11-01

    Many guidelines recommend metformin as first-line therapy for patients with type 2 diabetes. This recommendation is primarily based on the results of the Ukpds trial published in 1998. However, the methodology of this trial has been criticised. In 2014, does the harm-benefit balance of metformin still justify its first-line use in type 2 diabetes? To answer this question, we conducted a review of the literature using the standard Prescrire methodology. In the Ukpds trial, involving about 1700 overweight diabetic patients, metformin monotherapy for about 10 years was more effective in reducing mortality than glycaemic control based mainly on dietary measures, and also more effective than treatment with a sulphonylurea such as chlorpropamide or glibenclamide, or with insulin. However, these results are undermined by several methodological flaws. In the Adopt trial, in which about 4400 patients were followed for 4 years, metformin, glibenclamide and rosiglitazone did not have significantly different effects on the risk of death or cardiovascular events. A meta-analysis of ten randomised trials versus placebo or other hypoglycaemic drugs did not show that metformin monotherapy had a statistically significant effect on mortality. In the Cosmic trial, including more than 5000 patients, metformin monotherapy for one year was not more effective in reducing mortality than another oral hypoglycaemic drug. In the Spread-Dimcad trial in 304 diabetic patients with coronary artery disease, metformin monotherapy appeared to be more effective in preventing cardiovascular complications than glipizide after 5 years of follow-up. The adverse effects of metformin mainly consist of dose-dependent gastrointestinal disorders and rare cases or life-threatening lactic aciaosis. Kidney failure reduces metformin elimination. Metformin rarely causes hypoglycaemia and has no effect on body weight. It does not increase cancer-related mortality. It sometimes causes vitamin B12 deficiency leading to macrocytic anaemia or peripheral neuropathy. Metformin mainly carries a risk of interactions with drugs that impair renal function, such as non-steroidal anti-inflammatory drugs and iodinated contrast media. Renal failure can lead to metformin accumulation and an increased risk of lactic acidosis. In mid-2014, the only study to show a reduction in mortality and complications of diabetes remains the Ukpds trial. Taken together, the available data suggest that metformin monotherapy tends to reduce mortality and cardiovascular morbidity and mortality. Its adverse effects have been extensively studied and are acceptable provided renal function is monitored, especially in situations in which patients are at risk of kidney failure.The harm-benefit balance of metformin monotherapy remains favourable in most patients with type 2 diabetes when dietary measures alone are not sufficient. PMID:25954799

  8. Simultaneous determination of 11 active components in two well-known traditional Chinese medicines by HPLC coupled with diode array detection for quality control.

    Science.gov (United States)

    Yin, Lianhong; Lu, Binan; Qi, Yan; Xu, Lina; Han, Xu; Xu, Youwei; Peng, Jinyong; Sun, Changkai

    2009-05-01

    A simple and sensitive high-performance liquid chromatography coupled with diode array detection (HPLC-DAD) method was investigated for simultaneous determination of 11 components (chlorogenic acid, coptisine, epiberberine, jatrorrhizine, berberine, palmatine, baicalin, wogonoside, baicalein, wogonin and chrysin) in Qinhuanghouzheng (QHHZ) capsule and Xiaoerqingre (XEQR) tablet, for quality control of these two well-known traditional Chinese medicines (TCMs). The method was established using an Eclipse Plus C(18) (150 mm x 4.6 mm i.d., 5 microm) column. The mobile phase comprising methanol (A) 3% phosphoric acid (B) (pH 2.0, adjusted by triethylamine) was used to elute the targets in gradient elution mode. Flow rate and detection wavelength were set at 0.8 mL/min and 270 nm, respectively. All calibration curves showed good linearity with R(2) > 0.9995. Inter- and intra-day precisions for all investigated components expressed as relative standard deviation (R.S.D.) ranged from 0.26% to 1.77%. Recoveries measured at three concentrations were in the range of 95.0-103.0% with R.S.D. Phellodendron amurense Rupr. PMID:19264437

  9. Health status of adults with Short Stature: A comparison with the normal population and one well-known chronic disease (Rheumatoid Arthritis

    Directory of Open Access Journals (Sweden)

    Naess Eva E

    2007-02-01

    Full Text Available Abstract Background To examine the subjective health status of adults with short stature (ShSt and compare with the general population (GP and one well-known chronic disease, rheumatoid artritis (RA. In addition, to explore the association between age, gender, height, educational level and different aspects of health status of adults with short stature. Methods A questionnaire was mailed to 72 subjects with short stature registered in the database of a Norwegian resource centre for rare disorders, response rate 61% (n = 44, age 16–61. Health status was assessed with SF-36 version 2. Comparison was done with age and gender matched samples from the general population in Norway (n = 264 and from subjects with RA (n = 88. Results The ShSt sample reported statistically significant impaired health status in all SF-36 subscales compared with the GP sample, most in the physical functioning, Mean Difference (MD 34 (95% Confidence Interval (CI 25–44. The ShSt reported poorer health status in mental health, MD 11 (95% CI 4–18 and social functioning, MD 11 (95% CI 2–20 but better in role physical MD 13 (95% CI 1–25 than the RA sample. On the other subscales there were minor difference between the ShSt and the RA sample. Within the short stature group there was a significant association between age and all SF-36 physical subcales, height was significantly associated with physical functioning while level of education was significantly associated with mental health. Conclusion People with short stature reported impaired health status in all SF-36 subscales indicating that they have health problems that influence their daily living. Health status seems to decline with increasing age, and earlier than in the general population.

  10. EFECTO ANTITROMBÓTICO, UNA CARACTERÍSTICA POCO CONOCIDA DE LAS FRUTAS Y HORTALIZAS ANTITHROMBOTIC EFFECT, A NOT WELL KNOWN CHARACTERISTIC OF FRUITS AND VEGETABLES

    Directory of Open Access Journals (Sweden)

    Constanza Torres U

    2008-03-01

    Full Text Available Las enfermedades cardiovasculares (ECV son la principal causa de mortalidad en el mundo. Varios de los factores de riesgo de las ECV, como dislipidemias, hipertensión arterial y diabetes mellitus, son influenciados por la alimentación. Es conocido que las frutas y hortalizas contienen antioxidantes, y que su consumo en una cantidad adecuada disminuye el riesgo cardiovascular. Sin embargo, su efecto antitrombótico (antiagregante plaquetario, anticoagulante y fibrinolítico es poco conocido. En esta revisión se describen brevemente dichos efectos, tanto in vitro como in vivo, y los posibles mecanismos que podrían explicar éstos. En cuanto al efecto antiagregante plaquetario, entre las frutas que poseen dicha característica se incluyen uva negra, piña, frutilla y kiwi. Entre las hortalizas en que se ha descrito efecto antiagregante están el ajo, la cebolla, el cebollín, el tomate y el melón. Por su parte, el efecto anticoagulante, entre las frutas, sólo se ha encontrado en la piña, y entre las hortalizas en ajos y cebollas. El efecto fibrinolítico se ha descrito en frutas como el kiwi y la piña, y hortalizas como el ajo, las cebollas y la soya. Algunas frutas (piña y kiwi y hortalizas (ajo y cebollas presentan más de un efecto antitrombótico por lo que seguramente su consumo regular protege de las ECV. Nosotros hemos iniciado el estudio, por lo pronto in vitro, del posible efecto antitrombótico de frutas y hortalizas de la Región del Maule. Siendo necesario aumentar el consumo interno y las exportaciones de frutas y hortalizas, tanto para mejorar la salud de la población como desde el punto de vista económico, parece relevante contribuir al conocimiento de los efectos aquí descritos, los que son menos conocidos que el efecto antioxidanteCardiovascular diseases (CVD are the leading cause of death in the world. Several risk factors for CVD, such as lipid disorders, hypertension and diabetes mellitus, are influenced by food. It is well known that fruits and vegetables contain antioxidants and its adequate consumption reduces cardiovascular risk. However, its antithrombotic effect (antiplatelet agent, anticoagulant and fibrinolytic is little known. This review briefly describes these effects, both in vivo and in vitro, and the possible mechanisms that could explain this effect. Fruits such as black grape, pineapple, strawberry and kiwi show this effect. Among the vegetables that have antiaggregatory effect are garlic, onions, welsh onions, tomatoes and melons. On the other hand, the anticoagulant effect has only been found in fruits like pineapple, and among the vegetables in garlic and onions. The fibrinolytic effect has been described in fruits like kiwi and pineapple, and in vegetables such as garlic, onions and soybeans. Some fruits (pineapple and kiwi and vegetables (onion and garlic have more than one antithrombotic effect so their regular consumption certainly protects from CVD. We have begun the study, initially in vitro, of the potential antithrombotic effect of fruits and vegetables in the Maule Region. It is necessary to increase our domestic consumption and export of fruits and vegetables, both to improve the health of the population and the economy. The reasons above stated describe the importance of the contribution of knowledge due to the fact that antioxidant effects are less known

  11. EFECTO ANTITROMBÓTICO, UNA CARACTERÍSTICA POCO CONOCIDA DE LAS FRUTAS Y HORTALIZAS / ANTITHROMBOTIC EFFECT, A NOT WELL KNOWN CHARACTERISTIC OF FRUITS AND VEGETABLES

    Scientific Electronic Library Online (English)

    Constanza, Torres U; Luis, Guzmán J; Rodrigo, Moore-Carrasco; Iván, Palomo G.

    2008-03-01

    Full Text Available Las enfermedades cardiovasculares (ECV) son la principal causa de mortalidad en el mundo. Varios de los factores de riesgo de las ECV, como dislipidemias, hipertensión arterial y diabetes mellitus, son influenciados por la alimentación. Es conocido que las frutas y hortalizas contienen antioxidantes [...] , y que su consumo en una cantidad adecuada disminuye el riesgo cardiovascular. Sin embargo, su efecto antitrombótico (antiagregante plaquetario, anticoagulante y fibrinolítico) es poco conocido. En esta revisión se describen brevemente dichos efectos, tanto in vitro como in vivo, y los posibles mecanismos que podrían explicar éstos. En cuanto al efecto antiagregante plaquetario, entre las frutas que poseen dicha característica se incluyen uva negra, piña, frutilla y kiwi. Entre las hortalizas en que se ha descrito efecto antiagregante están el ajo, la cebolla, el cebollín, el tomate y el melón. Por su parte, el efecto anticoagulante, entre las frutas, sólo se ha encontrado en la piña, y entre las hortalizas en ajos y cebollas. El efecto fibrinolítico se ha descrito en frutas como el kiwi y la piña, y hortalizas como el ajo, las cebollas y la soya. Algunas frutas (piña y kiwi) y hortalizas (ajo y cebollas) presentan más de un efecto antitrombótico por lo que seguramente su consumo regular protege de las ECV. Nosotros hemos iniciado el estudio, por lo pronto in vitro, del posible efecto antitrombótico de frutas y hortalizas de la Región del Maule. Siendo necesario aumentar el consumo interno y las exportaciones de frutas y hortalizas, tanto para mejorar la salud de la población como desde el punto de vista económico, parece relevante contribuir al conocimiento de los efectos aquí descritos, los que son menos conocidos que el efecto antioxidante Abstract in english Cardiovascular diseases (CVD) are the leading cause of death in the world. Several risk factors for CVD, such as lipid disorders, hypertension and diabetes mellitus, are influenced by food. It is well known that fruits and vegetables contain antioxidants and its adequate consumption reduces cardiova [...] scular risk. However, its antithrombotic effect (antiplatelet agent, anticoagulant and fibrinolytic) is little known. This review briefly describes these effects, both in vivo and in vitro, and the possible mechanisms that could explain this effect. Fruits such as black grape, pineapple, strawberry and kiwi show this effect. Among the vegetables that have antiaggregatory effect are garlic, onions, welsh onions, tomatoes and melons. On the other hand, the anticoagulant effect has only been found in fruits like pineapple, and among the vegetables in garlic and onions. The fibrinolytic effect has been described in fruits like kiwi and pineapple, and in vegetables such as garlic, onions and soybeans. Some fruits (pineapple and kiwi) and vegetables (onion and garlic) have more than one antithrombotic effect so their regular consumption certainly protects from CVD. We have begun the study, initially in vitro, of the potential antithrombotic effect of fruits and vegetables in the Maule Region. It is necessary to increase our domestic consumption and export of fruits and vegetables, both to improve the health of the population and the economy. The reasons above stated describe the importance of the contribution of knowledge due to the fact that antioxidant effects are less known

  12. 100 km under ground. Longest well-known aqueduct tunnel of the antique in Jordan and Syria; 100 km unter Tage. Laengster bisher bekannter Aquaedukttunnel der Antike in Jordanien und Syrien

    Energy Technology Data Exchange (ETDEWEB)

    Doering, Mathias [Technische Univ. Bergakademie Freiberg (Germany). IWTG

    2010-05-15

    Since 2004, the author of the contribution under consideration investigates an ancient tunnel system with unknown extents in the border area between Jordan and Syria. It is a part of a nearly 170 km long Roman aqueduct which supplies three cities with water. The nearly 106 km long, partly plastered tunneling system was built from approximately 2,900 building pits with stairs in open ends tunneling. Not only mallet and iron, but also half-mechanical propulsion equipment were used due to regular cut traces. The aqueduct might be one the most extensive aqueducts in the Roman antiquity. The tunnel might be the longest well-known tunnel from the antiquity.

  13. IgG4-related Hashimoto’s thyroiditis – A new variant of a well known disease / Tireoidite de Hashimoto associada a IgG4 – Uma nova variante de uma doença bem conhecida

    Scientific Electronic Library Online (English)

    Henrique Vara, Luiz; Diogo, Gonçalves; Tiago Nunes da, Silva; Isabel, Nascimento; Ana, Ribeiro; Manuela, Mafra; Isabel, Manita; Jorge, Portugal.

    2014-11-01

    Full Text Available A tireoidite de Hashimoto (TH) foi caracterizada durante muitos anos como uma entidade clinicopatológica bem definida, mas é atualmente considerada uma patologia heterogênea. A TH associada a IgG4 apresenta-se como um novo subtipo, sendo caracterizada por inflamação da tireoide com numerosos plasmóc [...] itos IgG4-positivos e fibrose extensa. É possível que pertença ao espectro da doença sistêmica associada a IgG4. Relatamos o caso de um homem português de 56 anos que se apresentou com aumento progressivo do volume cervical e disfagia, com um mês de evolução. A avaliação laboratorial revelou elevação dos parâmetros inflamatórios, hipotireoidismo subclínico e níveis muito elevados de autoanticorpos tireoidianos. Por ultrassonografia cervical demonstrou-se tireoide aumentada, heterogênea, com dois nódulos hipoecoicos. Foi realizada citologia aspirativa com agulha fina guiada por ultrassom, compatível com tireoidite linfocítica. O doente foi submetido à tireoidectomia total e o exame histológico revelou achados típicos de TH, extensa fibrose localizada dentro da cápsula tireoidiana e infiltrado linfoplasmocitário, com >50 plasmócitos IgG4-positivos por campo de grande ampliação e uma relação IgG4/IgG >40%. Após cirurgia, a concentração sérica de IgG4 encontrava-se no limite superior do normal. Ocorreu melhoria sintomática e redução dos parâmetros inflamatórios. A função tireoidiana foi controlada com levotiroxina. Relatamos o primeiro caso de TH associada a IgG4 num indivíduo não asiático. Além disso, realizamos uma revisão da literatura sobre doença associada a IgG4 e TH associada a IgG4. Este caso destaca uma nova variante da TH e permite aos médicos reconhecerem suas principais características clínicas, proporcionando diagnóstico e tratamento adequados. Abstract in english Hashimoto’s thyroiditis (HT) has been characterized for many years as a well-defined clinicopathologic entity, but is now considered a heterogeneous disease. IgG4-related HT is a new subtype characterized by thyroid inflammation rich in IgG4-positive plasma cells and marked fibrosis. It may be part [...] of the systemic IgG4-related disease. We report a case of a 56-year-old Portuguese man who presented with a one-month history of progressive neck swelling and dysphagia. Laboratory testing revealed increased inflammatory parameters, subclinical hypothyroidism and very high levels of thyroid autoantibodies. Cervical ultrasound (US) demonstrated an enlarged and heterogeneous thyroid gland and two hypoechoic nodules. US-guided fine needle aspiration cytology was consistent with lymphocytic thyroiditis. The patient was submitted to total thyroidectomy and microscopic examination identified typical findings of HT, marked fibrosis limited within the thyroid capsule and lymphoplasmacytic infiltration, with >50 IgG4-positive plasma cells per high-power field and an IgG4/IgG ratio of >40%. After surgery, serum IgG4 concentration was high-normal. Symptoms relief and reduction in laboratory inflammatory parameters were noticed. Thyroid function is controlled with levothyroxine. To our knowledge we report the first case of IgG4-related HT in a non-Asian patient. We also perform a review of the literature regarding IgG4-related disease and IgG4-related HT. Our case highlights this new variant of the well known HT, and helps physicians in recognizing its main clinical features, allowing for proper diagnosis and treatment.

  14. Accretion onto some well-known regular black holes

    OpenAIRE

    Jawad, Abdul; Shahzad, M. Umair

    2016-01-01

    In this work, we discuss the accretion onto static spherically symmetric regular black holes for specific choices of the equation of state parameter. The underlying regular black holes are charged regular black holes using the Fermi–Dirac distribution, logistic distribution, nonlinear electrodynamics, respectively, and Kehagias–Sftesos asymptotically flat regular black holes. We obtain the critical radius, critical speed, and squared sound speed during the accretion process near the regular b...

  15. Accretion onto Some Well-Known Regular Black Holes

    OpenAIRE

    Jawad, Abdul; Shahzad, M. Umair

    2016-01-01

    In this work, we discuss the accretion onto static spherical symmetric regular black holes for specific choices of equation of state parameter. The underlying regular black holes are charged regular black hole using Fermi-Dirac Distribution, logistic distribution, nonlinear electrodynamics, respectively and Kehagias-Sftesos asymptotically flat regular black hole. We obtain the critical radius, critical speed and squared sound speed during the accretion process near the regular black holes. We...

  16. A Well-Known But Still Surprising Generator

    Science.gov (United States)

    Haugland, Ole Anton

    2014-12-01

    The bicycle generator is often mentioned as an example of a method to produce electric energy. It is cheap and easily accessible, so it is a natural example to use in teaching. There are different types, but I prefer the old side-wall dynamo. The most common explanation of its working principle seems to be something like the illustration in Fig. 1. The illustration is taken from a popular textbook in the Norwegian junior high school.1 Typically it is explained as a system of a moving magnet or coils that directly results in a varying magnetic field through the coils. According to Faraday's law a voltage is induced in the coils. Simple and easy! A few times I have had a chance to glimpse into a bicycle generator, and I was somewhat surprised to sense that the magnet rotated parallel to the turns of the coil. How could the flux through the coil change and induce a voltage when the magnet rotated parallel to the turns of the coil? When teaching electromagnetic induction I have showed the students a dismantled generator and asked them how this could work. They naturally found that this was more difficult to understand than the principle illustrated in Fig. 1. Other authors in this journal have discussed even more challenging questions concerning electric generators.2,3

  17. Log-concavity property for some well-known distributions

    OpenAIRE

    G.R. Mohtashami Borzadaran; H. A. Mohtashami Borzadaran

    2011-01-01

    Interesting properties and propositions, in many branches of science such as economics have been obtained according to the property of cumulative distribution function of a random variable as a concave function. Caplin and Nalebuff (1988,1989), Bagnoli and Khanna (1989) and Bagnoli and Bergstrom (1989 , 1989, 2005) have discussed the log-concavity property of probability distributions and their applications, especially in economics. Log-concavity concerns twice dif...

  18. Accretion onto Some Well-Known Regular Black Holes

    CERN Document Server

    Jawad, Abdul

    2016-01-01

    In this work, we discuss the accretion onto static spherical symmetric regular black holes for specific choices of equation of state parameter. The underlying regular black holes are charged regular black hole using Fermi-Dirac Distribution, logistic distribution, nonlinear electrodynamics, respectively and Kehagias-Sftesos asymptotically flat regular black hole. We obtain the critical radius, critical speed and squared sound speed during the accretion process near the regular black holes. We also study the behavior of radial velocity, energy density and rate of change of mass for each regular black holes.

  19. A Well-Known but Still Surprising Generator

    Science.gov (United States)

    Haugland, Ole Anton

    2014-01-01

    The bicycle generator is often mentioned as an example of a method to produce electric energy. It is cheap and easily accessible, so it is a natural example to use in teaching. There are different types, but I prefer the old side-wall dynamo. The most common explanation of its working principle seems to be something like the illustration in Fig.…

  20. Simple Expalanation of a Well-Known Collision Experiment.

    Science.gov (United States)

    Herrmann, F.; Schmalzle, P.

    1981-01-01

    Explains that the result of collision experiments with a linear arrangement of several identical elastic balls cannot be predicted solely from the conservation laws and energy and momentum. Indicates that the system of balls must be capable of dispersion-free energy propagation. (Author/JN)

  1. [Controlled randomized clinical trials].

    Science.gov (United States)

    Jaillon, Patrice

    2007-01-01

    It is generally agreed that the first comparative clinical trial in history was done by James Lind in 1747, in the treatment of scurvy. The general bases of modern experimental medicine were published by Claude Bernard in 1865. However, it is the development of new drugs and the evolution of methodological concepts that led to the first randomized controlled clinical trial, in 1948, which showed that the effects of streptomycin on pulmonary tuberculosis were significantly different from those of a placebo. Today, "evidence-based" medicine aims to rationalize the medical decision-making process by taking into account, first and foremost, the results of controlled randomized clinical trials, which provide the highest level of evidence. In the second half of the 20th century it became clear that different kinds of clinical trials might not provide the same level of evidence. Practitioners' intimate convictions must be challenged by the results of controlled clinical trials. Take the CAST trial for example, which, in 1989, tested antiarrhythmic drugs versus placebo in patients with myocardial infarction. It was well known that ventricular arrhythmias were a factor of poor prognosis in coronary heart disease, and it was therefore considered self-evident that drug suppression of these ventricular arrhythmias would reduce the mortality rate. In the event, the CAST trial showed the exact opposite, with an almost 3-fold increase in total mortality among patients with coronary heart disease who were treated with antiarrhythmic drugs. These results had a profound impact on the use of antiarrythmic drugs, which became contraindicated after myocardial infarction. A clinical trial has to fulfill certain methodological standards to be accepted as evidence-based medicine. First, a working hypothesis has to be formulated, and then the primary outcome measure must be chosen before beginning the study. An appropriate major endpoint for efficacy must be selected, in keeping with the primary outcome. One may choose either a single endpoint (for instance all-cause mortality; or a composite criterion taking into account various manifestations of the same health disorder (for instance cardiovascular mortality plus non lethal myocardial infarction plus non lethal ischemic stroke). The trial must be controlled, i.e. must compare the intervention with a standard or dummy treatment. A randomization process is used to ensure that the groups are comparable. The patients must be monitored and the results analyzed in double-blind manner The required number of patients is calculated based on the working hypothesis ("superiority" trial or "equivalence" trial), as well as the spontaneous variability of the main endpoint, and the alpha and beta statistical risks. The experimental design (cross-over or parallel groups) is chosen according to the primary outcome measure and the disease characteristics. Finally, the results must be analyzed in an intention-to-treat manner, taking into account all the patients who were initially randomized. The results of these methodologically sound trials form the basis for official therapeutic guidelines, which help physicians to choose the best treatments for their patients. However, extrapolating the results of randomized controlled clinical trials to the general patient population is not always straightforward. For instance, it is well known that patients who participate in clinical trials are highly selected and therefore somewhat unrepresentative. In addition, their numbers are limited and the treatment period is often much shorter than in routine management of a chronic disease. Finally, patients in clinical trials are monitored more closely than in routine practice. This is why we need post-marketing pharmacoepidemiological studies, in which cohorts of patients exposed to the treatment in question are monitored sufficiently long to determine the precise risk-benefit ratio. Controlled clinical trials are lacking in various fields of biomedical research, either because drug companies consi

  2. DISTRIBUCIÓN, HISTORIA NATURAL Y CONSERVACIÓN DE UNA RANA MARSUPIAL POCO CONOCIDA, GASTROTHECA HELENAE (ANURA: HEMIPHRACTIDAE), EN EL PARQUE NACIONAL NATURAL TAMÁ, COLOMBIA / DISTRIBUTION, NATURAL HISTOR Y AND CONSERVATION OF THE NOT VERY WELL KNOWN MARSUPIAL FROG GASTROTHECA HELENAE (ANURA: HEMIPHRACTIDAE) IN THE TAMÁ NATIONAL PARK, COLOMBIA

    Scientific Electronic Library Online (English)

    Aldemar A, Acevedo; Karen Lizeth, Silva; Rosmery, Franco; Diego J, Lizcano.

    2011-07-01

    Full Text Available Gastrotheca helenae es una rana marsupial poco conocida, dada su limitada distribución al estar restringida al complejo Macizo El Tamá compartido por Colombia y Venezuela. Evaluamos el estado actual de sus poblaciones mediante la búsqueda en nuevas localidades y describimos aspectos de la historia n [...] atural de la especie, con el fin de generar futuros planes de conservación para los anfibios de zonas altas de la Cordillera Nororiental. Abstract in english The marsupial frog Gastrotheca helenae is a not very well known species, as it has a limited distribution that is restricted to the Tamá massif complex shared by Colombia and Venezuela. We assessed the current status of their populations, by means of a search in new locations and we describe aspects [...] of the species natural history, in order to generate future conservation plans for the amphibians in the highlands of the North Eastern Cordillera.

  3. La importancia de los cuentos conocidos en el aprendizaje del inglés como lengua extranjera: una propuesta metodológica para el aula de 5 años1 / The importance of well-known stories to English language learning: a methodological proposal for 5 years old students

    Directory of Open Access Journals (Sweden)

    Mª del Mar González-Martín

    2016-01-01

    Full Text Available Resumen Las narraciones de cuentos son un recurso ampliamente utilizado en la enseñanza del inglés como lengua extranjera en el aula de educación infantil, pudiéndose introducir de diferentes modos. En el trabajo presentamos el diseño de una propuesta para fomentar la participación de los niños en la narración de cuentos en inglés que son ya conocidos en su lengua madre. Este enfoque, basado en dos métodos, el TPR-Storytelling y el método Artigal, se pone a prueba en una clase con niños de 5 años, en una intervención educativa de 3 sesiones. Los resultados de este estudio piloto muestran la eficacia de la propuesta en relación al grado de participación en la actividad, comprensión general y adquisición de vocabulario. Por otra parte, esta experiencia visibiliza las fortalezas y aspectos a mejorar de la propuesta, permitiendo el rediseño de la misma en este sentido. Abstract Storytelling is a common resource to teach English as a foreign language to very young children, this can be done in different ways. In this paper, we present the design of an approach to foster children’s participation in English storytelling of well-known stories in their mother tongue. This approach, based on two methods, TPR-Storytelling and Artigal’s, is tested in a class of five-year old children, in a 3-session educational intervention. The results of this pilot study show the effectiveness of the proposal in terms of degree of participation in the activity, general understanding and vocabulary acquisition. Additionally, the experience brings to the fore the strengths and weaknesses of the method and allows its redesign on these grounds.

  4. Clinical Trials

    Science.gov (United States)

    ... by participating in a clinical trial is to science first and to the patient second. More About Clinical Trials Comparing Alternative Treatments Benefits of Participation Treatment During a Trial Participation Requirements Drawbacks of ...

  5. Clinical Trials

    Science.gov (United States)

    Clinical trials are research studies that test how well new medical approaches work in people. Each study ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to ...

  6. Types of 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.

  7. How well-known is the Cephalaspidean fauna (Mollusca: Opisthobranchia) in the Indo-Pacific region?

    DEFF Research Database (Denmark)

    Cedhagen, Tomas

    The gastropod group Cephalaspidea contains about 700 recent species worldwide. The status of the research on the group, indicated as the number of described species, in the tropical Indo-Pacific region is compared with other areas. The number ofspecies are 118 in the Indo-Pacific, 168 in Japan, a...

  8. A phytopharmacological review on Justicia picta (Acanthaceae): A well known tropical folklore medicinal plant

    OpenAIRE

    Pradeep Singh; Ratan Lal Khosa; Garima Mishra; Mohd Adil Tahseen

    2015-01-01

    The Acanthaceae family is an important source of therapeutic drugs and the ethno pharmacological knowledge of this family requires urgent documentation as several of its species are near extinction. Justicia is the largest genus of Acanthaceae with approximately 600 species. Aim of the present review is to present literature for the traditional uses & pharmacological review of Justicia picta (Family: Acanthaceae) and to discuss further priorities of research yet to be discovered.

  9. The Effect of Thread-Level Speculation on a Set of Well-known Web Applications

    OpenAIRE

    Martinsen, Jan Kasper; Grahn, Håkan; Isberg, Anders

    2011-01-01

    Previous studies have shown that there are large di?erences between the workload of established JavaScript benchmarks and popular Web Applications. It has also been shown that popular optimization techniques, such as just-in-time compilation, many times degrade the performance of Web Applications. Further, since JavaScript is a sequential language it cannot take advantage of multicore processors. In this paper, we propose to use Thread-Level Speculation (TLS) as an alternative optimization te...

  10. About the activity and selectivity of less well-known metathesis catalysts during ADMET polymerizations

    Directory of Open Access Journals (Sweden)

    Hatice Mutlu

    2010-12-01

    Full Text Available We report on the catalytic activity of commercially available Ru-indenylidene and “boomerang” complexes C1, C2 and C3 in acyclic diene metathesis (ADMET polymerization of a fully renewable ?,?-diene. A high activity of these catalysts was observed for the synthesis of the desired renewable polyesters with molecular weights of up to 17000 Da, which is considerably higher than molecular weights obtained using the same monomer with previously studied catalysts. Moreover, olefin isomerization side reactions that occur during the ADMET polymerizations were studied in detail. The isomerization reactions were investigated by degradation of the prepared polyesters via transesterification with methanol, yielding diesters. These diesters, representing the repeat units of the polyesters, were then quantified by GC-MS.

  11. Unusual liquid-liquid phase transition in aqueous mixtures of a well-known dendrimer.

    Science.gov (United States)

    da Costa, Viviana C P; Annunziata, Onofrio

    2015-10-28

    Liquid-liquid phase separation (LLPS) has been extensively investigated for polymer and protein solutions due to its importance in mixture thermodynamics, separation science and self-assembly processes. However, to date, no experimental studies have been reported on LLPS of dendrimer solutions. Here, it is shown that LLPS of aqueous solutions containing a hydroxyl-functionalized poly(amido amine) dendrimer of fourth generation is induced in the presence of sodium sulfate. Both the LLPS temperature and salt-dendrimer partitioning between the two coexisting phases at constant temperature were measured. Interestingly, our experiments show that LLPS switches from being induced by cooling to being induced by heating as the salt concentration increases. The two coexisting phases also show opposite temperature response. Thus, this phase transition exhibits a simultaneous lower and upper critical solution temperature-type behavior. Dynamic light-scattering and dye-binding experiments indicate that no appreciable conformational change occurs as the salt concentration increases. To explain the observed phase behavior, a thermodynamic model based on two parameters was developed. The first parameter, which describes dendrimer-dendrimer interaction energy, was determined by isothermal titration calorimetry. The second parameter describes the salt salting-out strength. By varying the salting-out parameter, it is shown that the model achieves agreement not only with the location of the experimental binodal at 25 °C but also with the slope of this curve around the critical point. The proposed model also predicts that the unusual temperature behavior of this phase transition can be described as the net result of two thermodynamic factors with opposite temperature responses: salt thermodynamic non-ideality and salting-out strength. PMID:26451401

  12. Mimicking Livor Mortis: a Well-Known but Unsubstantiated Color Profile in Sapromyiophily.

    Science.gov (United States)

    Chen, Gao; Ma, Xiao-Kai; Jürgens, Andreas; Lu, Jun; Liu, Er-Xi; Sun, Wei-Bang; Cai, Xiang-Hai

    2015-09-01

    By emitting strong scents resembling rotting organic materials suitable for oviposition and/or foraging of flies, sapromyiophilous flowers mimic the substrates that attract flies as pollinators. It has been suggested that the wide range of volatile organic compounds emitted by this deceptive pollination system reflects the trophic preferences of flies to different types of substrate, including herbivore and carnivore feces, carrion, and fruiting bodies of fungi. Previous studies suggest that floral scents play a particularly important role in sapromyiophily. However, few studies on the relative importance of floral color or synergy between visual and olfactory cues in sapromyiophily have been substantiated. In this study, we analyzed fetid floral odor, floral pigment composition, and reflectance of an Amorphophallus konjac C. Koch inflorescence, and we conducted bioassays with different visual and/or olfactory cues to explore an unsubstantiated color profile in sapromyiophily: mimicking livor mortis. Our analysis showed A. konjac can emit oligosulphide-dominated volatile blends similar to those emitted by carrion. Necrophagous flies cannot discriminate between the color of an inflorescence, livor mortis, and floral pigments. We concluded that mimicking livor mortis may represent a common tactic of pollinator attraction in "carrion flower" systems within angiosperms. PMID:26306591

  13. Comparing the personality of three well-known sporting brands in Iran

    OpenAIRE

    Mohmood Mohammadian; Hamidreza Asgari Dehabadi

    2012-01-01

    A significant amount of literature specifies that there are benefits for having a favorable brand personality, such as purchase intentions and enhanced brand attitudes and higher degrees of consumer trust and loyalty. Brand differentiation is one of most important issues to handle competition in the hostile marketplace. A reliable solution for establishing the distinctiveness of a brand is through brand personality. This study analyzes the personality of Adidas, Nike and Puma brands in Iran u...

  14. The Effect of Thread-Level Speculation on a Set of Well-known Web Applications

    OpenAIRE

    Martinsen, Jan; Grahn, Håkan; Isberg, Anders

    2011-01-01

    Previous studies have shown that there are large di?erences between the workload of established JavaScript benchmarks and popular Web Applications. It has also been shown that popular optimization techniques, such as just-in-time compilation, many times degrade the performance of Web Applications. Further, since JavaScript is a sequential language it cannot take advantage of multicore processors. In this paper, we propose to use Thread-Level Speculation (TLS) as an ...

  15. About the activity and selectivity of less well-known metathesis catalysts during ADMET polymerizations.

    Science.gov (United States)

    Mutlu, Hatice; Montero de Espinosa, Lucas; Türünç, O?uz; Meier, Michael A R

    2010-01-01

    We report on the catalytic activity of commercially available Ru-indenylidene and "boomerang" complexes C1, C2 and C3 in acyclic diene metathesis (ADMET) polymerization of a fully renewable ?,?-diene. A high activity of these catalysts was observed for the synthesis of the desired renewable polyesters with molecular weights of up to 17000 Da, which is considerably higher than molecular weights obtained using the same monomer with previously studied catalysts. Moreover, olefin isomerization side reactions that occur during the ADMET polymerizations were studied in detail. The isomerization reactions were investigated by degradation of the prepared polyesters via transesterification with methanol, yielding diesters. These diesters, representing the repeat units of the polyesters, were then quantified by GC-MS. PMID:21160555

  16. The well-known unknown photographer Jaan Klõšeiko / Ellu Maar

    Index Scriptorium Estoniae

    Maar, Ellu, 1982-

    2010-01-01

    Graafik ja fotograaf Jaan Klõšeikost, kes on 45 aastat jäädvustanud kunsti- ja kultuurisündmusi. Galerii Vaal kodulehel ilmunud J. Klõšeiko fotoseeriatest (12), fotod valis ja saatesõnad kirjutas J. Klõšeiko

  17. Macro with Pico Cells (HETNETS System Behaviour using Well-Known Scheduling Algorithms

    Directory of Open Access Journals (Sweden)

    Haider Al Kim

    2014-11-01

    Full Text Available This paper demonstrates the concept of using Heterogeneous network s ( HetNets to improve Long Term Evolution (LTE system by introducing the LTE A dvance (LTE - A . The type of HetNets that has been chosen for this study is Macro with Pic o cells. Comparing the system performance with and without Pico cells has clearly illustrated using three well - know n scheduling algorithms ( Proportional Fair P F, Maximum Largest Weighted Delay First MLWDF and Exponential/Proportional Fair EXP/PF. The syst em is judged based on throughpu t, Pac ket Loss Ratio PLR , delay and f airness. . A simulation platform called LTE - Sim has been used to collect the data and produce the paper’s outcomes and graphs. The result s prove that adding Pico cells enhances the overall system performance. From the simulation outcomes, the overall system performance is as follows: throughput is duplicated or tripled based on the number of users , the PLR is almost quartered , the delay is nearly reduced ten times (PF case and c hange d to be a half (MLWDF/EXP cases, and the fairness stays closer to value of 1 . It is considered an efficient and cost effective way to increase the throughput, coverage and reduce the latency.

  18. Macro with Pico Cells (HetNets) System Behavior Using Well-known scheduling Algorithms

    OpenAIRE

    Haider Al Kim; Kumbesan Sandrasegaran; Pantha Ghosal,; Shouman Barua

    2014-01-01

    This paper demonstrates the concept of using Heterogeneous network s ( HetNets ) to improve Long Term Evolution (LTE) system by introducing the LTE A dvance (LTE - A) . The type of HetNets that has been chosen for this study is Macro with Pic o cells. Comparing the system performance with and without Pico cells has clearly illustrated using three well - know n scheduling algorithms ( Proportional Fair P F, Max...

  19. The well-known unknown photographer Jaan Klõšeiko / Ellu Maar

    Index Scriptorium Estoniae

    Maar, Ellu, 1982-

    2010-01-01

    Graafik ja fotograaf Jaan Klõšeikost, kes on 45 aastat jäädvustanud kunsti- ja kultuurisündmusi. Galerii Vaal kodulehel ilmunud J. Klõšeiko fotoseeriatest (12), fotod valis ja saatesõnad kirjutas J. Klõšeiko

  20. A Quantitative Relation between Modulational Instability and the Well-known Nonlinear Excitations

    CERN Document Server

    Zhao, Li-Chen

    2014-01-01

    We study on explicit relations between modulational instability and analytical nonlinear excitations in a self-focusing Kerr nonlinear fiber in anomalous group velocity dispersion regime, such as bright soliton, nonlinear continuous wave, Akhmediev breather, Peregrine rogue wave, and Kuznetsov-Ma breather. We present a quantitative correspondence between them based on the dominant frequency and propagation constant of each perturbation on a continuous wave background. Especially, we find rogue wave comes from modulational instability under the "resonance" perturbation with continuous wave background. These results will deepen our realization on rogue wave excitation and could be helpful for controllable nonlinear waves excitations in nonlinear fiber and other nonlinear systems.

  1. Comparing the personality of three well-known sporting brands in Iran

    Directory of Open Access Journals (Sweden)

    Mohmood Mohammadian

    2012-08-01

    Full Text Available A significant amount of literature specifies that there are benefits for having a favorable brand personality, such as purchase intentions and enhanced brand attitudes and higher degrees of consumer trust and loyalty. Brand differentiation is one of most important issues to handle competition in the hostile marketplace. A reliable solution for establishing the distinctiveness of a brand is through brand personality. This study analyzes the personality of Adidas, Nike and Puma brands in Iran using Aaker,s brand personality dimensions [Aakar (1997. Dimensions of brand personality. Journal of Marketing Resources, 24, 347–356]. First, data are collected using a questionnaire designed based on Aaker,s model. Second, the K-S and Friedman tests are done to analyze the collected data. Results indicate that in terms of sincerity and competence, Adidas scores are higher than two other brands. Nike in point of view of excitement, and Puma in terms of sophisticated and ruggedness dimensions have higher position in comparison to other brands.

  2. [Compilation of historical anecdotes about chronic wounds. Well-known people who have suffered from them].

    Science.gov (United States)

    García Fernández, Francisco Pedro; López Casanova, Pablo; Pancorbo Hidalgo, Pedro Luis; Verdú Soriano, José

    2009-01-01

    Throughout the course of human history many people have been affected by the presence of chronic wounds. Millions of anonymous people have suffered bed sores, varicose ulcers, arterial ulcers or neuropathic ulcers. But there have been some famous people who, from time to time, remove these lesions from their cloak of invisibility In our day and age, every time a famous person suffers from these wounds, we observe how the means of communication publicize this health problem. However famous people also suffered from these wounds in the past. In this article, the authors will review historical figures who died due to these feared sores. Kings or saints have been affected by this problem. Specifically the authors will focus on six historical figures: three kings, one composer and two saints,; the authors shall analyze the influence of chronic wounds as a cause of their deaths. This article was submitted at the VII National Symposium on Bed Sores and Chronic Wounds and at the First Latin American Congress on Ulcers and Wounds. PMID:19354144

  3. Mobility Assisted Solutions for Well-known Attacks in Mobile Wireless Sensor Network

    OpenAIRE

    Abu Saleh Md. Tayeen; A.F.M. Sultanul Kabir; Razib Hayat Khan

    2011-01-01

    Over the past few years the domain of wireless sensor networks applications is increasing widely. So security is becoming a major concern for WSN. These networks are generally deployed randomly and left unattended. These facts coupled together make it vulnerable to different dangerous attacks like node capture attack, node replication attack, wormhole attack, sinkhole attack etc. Several detection schemes and countermeasures have been proposed in the literature to defend against such attacks ...

  4. Gamma-enolase: a well known tumour marker, with a less-known role in cancer:

    OpenAIRE

    Kos, Janko; Vižin, Tjaša

    2015-01-01

    Gamma-enolase, known also as neuron-specific enolase (NSE), is an enzyme of the glycolytic pathway, which is expressed predominantly in neurons and cells of the neuroendocrine system. As a tumour marker it is used in diagnosis and prognosis of cancer; however, the mechanisms enrolling it in malignant progression remain elusive. As a cytoplasmic enzyme gamma-enolase is involved in increased aerobic glycolysis, the main source of energy in cancer cells, supporting cell proliferation. However, d...

  5. Disease-mongering through clinical trials.

    Science.gov (United States)

    González-Moreno, María; Saborido, Cristian; Teira, David

    2015-06-01

    Our goal in this paper is to articulate a precise concept of at least a certain kind of disease-mongering, showing how pharmaceutical marketing can commercially exploit certain diseases when their best definition is given through the success of a treatment in a clinical trial. We distinguish two types of disease-mongering according to the way they exploit the definition of the trial population for marketing purposes. We argue that behind these two forms of disease-mongering there are two well-known problems in the statistical methodology of clinical trials (the reference class problem and the distinction between statistical and clinical significance). Overcoming them is far from simple. PMID:25863220

  6. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... Veterans and the Public Frequently Asked Questions About Clinical Research Studies What is a clinical trial? A clinical trial is a research program ... were first tested in clinical trials. How do clinical trials work? Clinical trials follow a set of ...

  7. Stroke Trials Registry

    Science.gov (United States)

    ... News About Neurology Image Library Search The Internet Stroke Center Trials Registry Clinical Trials Interventions Conditions Sponsors ... a clinical trial near you Welcome to the Stroke Trials Registry Our registry of clinical trials in ...

  8. A randomized controlled trial of R-salbutamol for topical treatment of discoid lupus erythematosus

    DEFF Research Database (Denmark)

    Jemec, G B E; Ullman, S; Goodfield, M; Bygum, A; Olesen, A B; Berth-Jones, J; Nyberg, F; Cramers, M; Faergemann, J; Andersen, P; Kuhn, A; Ruzicka, T

    2009-01-01

    BACKGROUND: In a recent open pilot trial, R-salbutamol sulphate, a well-known molecule with anti-inflammatory effects, was tested successfully on patients with therapy-resistant discoid lupus erythematosus (DLE). OBJECTIVES: To compare the efficacy and safety of R-salbutamol cream 0.5% vs. placeb...

  9. Trial Watch

    Science.gov (United States)

    Galluzzi, Lorenzo; Vacchelli, Erika; Fridman, Wolf Hervé; Galon, Jerome; Sautès-Fridman, Catherine; Tartour, Eric; Zucman-Rossi, Jessica; Zitvogel, Laurence; Kroemer, Guido

    2012-01-01

    Since the advent of hybridoma technology, dating back to 1975, monoclonal antibodies have become an irreplaceable diagnostic and therapeutic tool for a wide array of human diseases. During the last 15 years, several monoclonal antibodies (mAbs) have been approved by FDA for cancer therapy. These mAbs are designed to (1) activate the immune system against tumor cells, (2) inhibit cancer cell-intrinsic signaling pathways, (3) bring toxins in the close proximity of cancer cells, or (4) interfere with the tumor-stroma interaction. More recently, major efforts have been made for the development of immunostimulatory mAbs that either enhance cancer-directed immune responses or limit tumor- (or therapy-) driven immunosuppression. Some of these antibodies, which are thought to facilitate tumor eradication by initiating or sustaining a tumor-specific immune response, have already entered clinical trials. In this Trial Watch, we will review and discuss the clinical progress of the most important mAbs that are have entered clinical trials after January 2008. PMID:22720209

  10. Clinical Trials Reporting Program

    Science.gov (United States)

    The Clinical Trial Reporting Program is a comprehensive database of all NCI-supported clinical trials. The database exists to identify gaps in clinical research andduplicative studies, prioritization and enhance patient accrual to trials by making physicians aware of relevant opportunities for participation in clinical trials.

  11. Discrete Trials Teaching

    Science.gov (United States)

    Ghezzi, Patrick M.

    2007-01-01

    The advantages of emphasizing discrete trials "teaching" over discrete trials "training" are presented first, followed by a discussion of discrete trials as a method of teaching that emerged historically--and as a matter of necessity for difficult learners such as those with autism--from discrete trials as a method for laboratory research. The…

  12. How Do Clinical Trials Work?

    Science.gov (United States)

    ... Studies NHLBI Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a ... protect patients and help produce reliable study results. Clinical Trial Protocol Each clinical trial has a master ...

  13. Clinical Trials and Older People

    Science.gov (United States)

    ... Clinical Trials and Older People Heath and Aging Clinical Trials and Older People What is a clinical ... trial is right for you. What is a clinical trial? A clinical trial is a particular type ...

  14. Can exposure limitations for well-known contact allergens be simplified? An analysis of dose-response patch test data

    DEFF Research Database (Denmark)

    Neergaard, Louise Arup; Menné, Torkil; Voelund, Aage; Johansen, Jeanne Duus

    2011-01-01

    Allergic contact dermatitis is triggered by chemicals in the environment. Primary prevention is aimed at minimizing the risk of induction, whereas secondary and tertiary prevention are aimed at reducing elicitation.......Allergic contact dermatitis is triggered by chemicals in the environment. Primary prevention is aimed at minimizing the risk of induction, whereas secondary and tertiary prevention are aimed at reducing elicitation....

  15. Aspects of the nutritional value of cooked Egyptian goose (Alopochen aegyptiacus) meat compared with other well-known fowl species.

    Science.gov (United States)

    Geldenhuys, Greta; Hoffman, Louwrens C; Muller, Nina

    2013-11-01

    There is no scientific research regarding Egyptian goose (Alopochen aegyptiacus) meat; therefore, a chemical analysis to establish the nutritional characteristics of the breast portion is described. Meat from guinea fowl, Pekin duck, ostrich, and broiler chicken were used as a reference. The high intramuscular fat content of Egyptian goose meat (5.6 g/100 g) may be linked to the fact that this species relies on fat for heat insulation and buoyancy. Egyptian goose meat is very high in polyunsaturated fatty acids (39.7%). The polyunsaturated fatty acid/saturated fatty acid ratio is within the recommendations (>0.4), although the n-6/n-3 ratio is higher than the suggested value of 5. The high Fe content of 7.5 mg/100 g is the differentiating factor within the mineral compositions and is related to the physical activity endured by the breast muscle of Egyptian geese. This study provides new insight into the nutritional characteristics of a meat species providing crucial information that is, as of yet, not available in the literature. PMID:24135611

  16. Diabetes and Behavioral Learning Principles: Often Neglected yet Well-Known and Empirically Validated Means of Optimizing Diabetes Care Behavior.

    Science.gov (United States)

    Stoeckel, Maggie; Duke, Danny

    2015-07-01

    Managing diabetes is known to be invasive, pervasive, and unrelenting, making adherence to the treatment regimen difficult to accomplish. Ongoing clinical and research efforts have attempted to address the struggles faced by youth and adults with diabetes. Recent research supports the integration of behavioral interventions into clinical practice to assist patients and families with the goal of improving health outcomes. Empirically supported and well-documented behavioral learning principles, particularly positive reinforcement, are often underutilized in modern diabetes care. We posit that most diabetes care providers are aware of these principles. However, the constraints of today's medical systems have become significant barriers to purposefully and consistently applying them to promote improved diabetes care. We provide a brief overview of basic behavioral principles and common barriers to implementation, discuss relevant interventions, and present several examples of applications in clinical settings. We conclude with recommendations to raise awareness regarding the importance of consistently integrating relevant behavioral learning principles and interventions into diabetes care settings. PMID:25957526

  17. A Big Five facet analysis of sub-clinical narcissism: understanding boldness in terms of well-known personality traits.

    Science.gov (United States)

    Furnham, Adrian; Crump, John

    2014-08-01

    This study aimed to examine a Big Five 'bright-side' analysis of a sub-clinical personality disorder, i.e. narcissism. A total of 6957 British adults completed the NEO-PI-R, which measures the Big Five Personality factors at the domain and the facet level, as well as the Hogan Development Survey (HDS), which has a measure of Narcissism called Bold as one of its dysfunctional interpersonal tendencies. Correlation and regression results confirmed many of the associations between the Big Five domains and facets (NEO-PI-R) and sub-clinical narcissism. The Bold (Narcissism) scale from the HDS was the criterion variable in all analyses. Bold individuals are disagreeable extraverts with very low scores on facet Modesty but moderately high scores on Assertiveness, Competence and Achievement Striving. The study confirmed work using different population groups and different measures. PMID:24733713

  18. Cucumber, melon, pumpkin, and squash: are rules of editing in flowering plants chloroplast genes so well known indeed?

    Science.gov (United States)

    Guzowska-Nowowiejska, Magdalena; Fiedorowicz, Ewa; Plader, Wojciech

    2009-04-01

    The similarities and differences in the chloroplast genes editing patterns of four species from one family (and two genera), which is the first-ever attempt at comparison of such data in closely related species, is discussed. The effective use of the chloroplast genes editing patterns in evolutionary studies, especially in evaluating the kinship between closely related species, is thereby proved. The results indicate that differences in editing patterns between different genera (Cucumis and Cucurbita) exist, and some novel editing sites can be identified even now. However, surprising is the fact of finding editing in the codon for Arg (in flowering plants detected before only in Cuscuta reflexa chloroplast genome, Funk et al.,[Funk H.T., Berg S., Krupinska K., Maier U.G. and Krause K., 2007. Complete DNA sequences of the plastid genomes of two parasitic flowering plants species, Cuscuta reflexa and Cuscuta gronovi. BMC Plant Biol. 7:45, doi: 10.1186/1471-2229-7-45.]), which was believed to have been lost during evolution before the emergence of angiosperms. In addition, the existence of silent editing in plant chloroplasts has been confirmed, and some probable reasons for its presence are pointed out herein. PMID:19162145

  19. Enabling Low Cost Biopharmaceuticals: A Systematic Approach to Delete Proteases from a Well-Known Protein Production Host Trichoderma reesei

    Science.gov (United States)

    Landowski, Christopher P.; Huuskonen, Anne; Wahl, Ramon; Westerholm-Parvinen, Ann; Kanerva, Anne; Hänninen, Anna-Liisa; Salovuori, Noora; Penttilä, Merja; Natunen, Jari; Ostermeier, Christian; Helk, Bernhard; Saarinen, Juhani; Saloheimo, Markku

    2015-01-01

    The filamentous fungus Trichoderma reesei has tremendous capability to secrete proteins. Therefore, it would be an excellent host for producing high levels of therapeutic proteins at low cost. Developing a filamentous fungus to produce sensitive therapeutic proteins requires that protease secretion is drastically reduced. We have identified 13 major secreted proteases that are related to degradation of therapeutic antibodies, interferon alpha 2b, and insulin like growth factor. The major proteases observed were aspartic, glutamic, subtilisin-like, and trypsin-like proteases. The seven most problematic proteases were sequentially removed from a strain to develop it for producing therapeutic proteins. After this the protease activity in the supernatant was dramatically reduced down to 4% of the original level based upon a casein substrate. When antibody was incubated in the six protease deletion strain supernatant, the heavy chain remained fully intact and no degradation products were observed. Interferon alpha 2b and insulin like growth factor were less stable in the same supernatant, but full length proteins remained when incubated overnight, in contrast to the original strain. As additional benefits, the multiple protease deletions have led to faster strain growth and higher levels of total protein in the culture supernatant. PMID:26309247

  20. Comparing emergy accounting with well-known sustainability metrics. The case of Southern Cone Common Market, Mercosur

    Energy Technology Data Exchange (ETDEWEB)

    Giannetti, B.F.; Almeida, C.M.V.B.; Bonilla, S.H. [Programa de Pos-Graduacao em Engenharia de Producao, Universidade Paulista, R. Dr. Bacelar 1212, Cep 04026-002, Sao Paulo (Brazil)

    2010-07-15

    The quality and the power of human activities affect the external environment in different ways that can be measured and evaluated by means of several approaches and indicators. While the scientific community has been publishing several proposals for sustainable development indicators, there is still no consensus regarding the best approach to the use of these indicators and their reliability to measure sustainability. It is important, therefore, to question the effectiveness of sustainable development indicators in an effort to continue in the search for sustainability. This paper compares the results obtained with emergy accounting with five global Sustainability Metrics (SMs) proposed in the literature to verify if metrics are communicating coherent and similar information to guide decision makers towards sustainable development. Results obtained using emergy indices are discussed with the aid of emergy ternary diagrams. Metrics are confronted with emergy results, and the degree of variability among them is analyzed using a correlation matrix created for the Mercosur nations. The contrast of results clearly shows that metrics arrive at different interpretations about the sustainability of the nations studied, but also that some metrics may be grouped and used more prudently. Mercosur is presented as a case study to highlight and explain the discrepancies and similarities among Sustainability Metrics, and to expose the extent of emergy accounting. (author)

  1. Comparing emergy accounting with well-known sustainability metrics: The case of Southern Cone Common Market, Mercosur

    Energy Technology Data Exchange (ETDEWEB)

    Giannetti, B.F. [Programa de Pos-Graduacao em Engenharia de Producao, Universidade Paulista, R. Dr. Bacelar 1212, Cep 04026-002, Sao Paulo (Brazil); Almeida, C.M.V.B., E-mail: cmvbag@unip.b [Programa de Pos-Graduacao em Engenharia de Producao, Universidade Paulista, R. Dr. Bacelar 1212, Cep 04026-002, Sao Paulo (Brazil); Bonilla, S.H. [Programa de Pos-Graduacao em Engenharia de Producao, Universidade Paulista, R. Dr. Bacelar 1212, Cep 04026-002, Sao Paulo (Brazil)

    2010-07-15

    The quality and the power of human activities affect the external environment in different ways that can be measured and evaluated by means of several approaches and indicators. While the scientific community has been publishing several proposals for sustainable development indicators, there is still no consensus regarding the best approach to the use of these indicators and their reliability to measure sustainability. It is important, therefore, to question the effectiveness of sustainable development indicators in an effort to continue in the search for sustainability. This paper compares the results obtained with emergy accounting with five global Sustainability Metrics (SMs) proposed in the literature to verify if metrics are communicating coherent and similar information to guide decision makers towards sustainable development. Results obtained using emergy indices are discussed with the aid of emergy ternary diagrams. Metrics are confronted with emergy results, and the degree of variability among them is analyzed using a correlation matrix created for the Mercosur nations. The contrast of results clearly shows that metrics arrive at different interpretations about the sustainability of the nations studied, but also that some metrics may be grouped and used more prudently. Mercosur is presented as a case study to highlight and explain the discrepancies and similarities among Sustainability Metrics, and to expose the extent of emergy accounting.

  2. The Antiretroviral Lectin Cyanovirin-N Targets Well-Known and Novel Targets on the Surface of Entamoeba histolytica Trophozoites ? †

    OpenAIRE

    Carpentieri, Andrea; Ratner, Daniel M.; Ghosh, Sudip K; Banerjee, Sulagna; Bushkin, G. Guy; Cui, Jike; Lubrano, Michael; Steffen, Martin; Costello, Catherine E; O'Keefe, Barry; Robbins, Phillips W; Samuelson, John

    2010-01-01

    Entamoeba histolytica, the protist that causes amebic dysentery and liver abscess, has a truncated Asn-linked glycan (N-glycan) precursor composed of seven sugars (Man5GlcNAc2). Here, we show that glycoproteins with unmodified N-glycans are aggregated and capped on the surface of E. histolytica trophozoites by the antiretroviral lectin cyanovirin-N and then replenished from large intracellular pools. Cyanovirin-N cocaps the Gal/GalNAc adherence lectin, as well as glycoproteins containing O-ph...

  3. A Study on the Knowledge, Attitude and Behavior of University Students’ Towards the Well Known Branded Products

    Directory of Open Access Journals (Sweden)

    Azize Hassan

    2011-12-01

    Full Text Available Nowadays branding, marketing literature appears to be an important concept. Consumers' attitudes towards goods and services together with increased levels of education also have become more sensitive. Many of the young people are the actual mass for the brand. At this point, young people's attitudes towards brands and information are important to determine the behavior. Heading from this importance, it was tried to measure knowledge, attitude and behavior of high brand awareness for products among 384 students who are learning in Gölba?? Campus of Gazi University. As a result of this research it was found that the joining students preferred the high brand awareness products. Accordingly, high brand awareness products are seen by students, as mostly reliable products, which provides possibility of protection to consumers that can be easily found on the shelves and have more promotions but they are thinking that their prices are not the same everywhere.

  4. Bio-MTBE. How to reduce CO{sub 2} footprint in fuels with a well known premium gasoline component

    Energy Technology Data Exchange (ETDEWEB)

    Busch, O.; Schade, A.; Rasch, H.; Schulte-Koerne, E. [Evonik Industries AG, Marl (Germany)

    2012-07-01

    With the revision of Renewable Energy Directive (RED) and Fuels Quality Directive (FQD) in 2009 the EU Commission promoted the use of biofuels, especially of those made from residues and waste because of their favourable CO{sub 2} footprint. Crude glycerol is an inevitable residue of conventional biodiesel production and can therefore be used to make 2{sup nd} generation biofuels, in this case bio-methanol. Methanol itself has several application issues as a fuel and can only be blended into gasoline at low quantities (max. 3 vol.-% according to European gasoline specification EN 228). However, today methanol is virtually absent in European gasoline due to its detrimental properties (e.g. corrosivity, water miscibility, etc.). In contrast to this, MTBE (methyl tertiary butyl ether) made from methanol and isobutylene is a high value gasoline component that can be blended into gasoline at high quantities without any application issues. Current European gasoline specification allows up to 15 vol.-%% and the revised FQD has enabled the specification to be expanded to up to 22 vol.-% MTBE in gasoline. Thus, bio-methanol converted into bio-MTBE is an appropriate pathway to get a 2{sup nd} generation biofuel into the blending pool with perfect compatibility with infrastructure and the existing car fleet. (orig.)

  5. Antimicrobial Growth Promoters Used in Animal Feed: Effects of Less Well Known Antibiotics on Gram-Positive Bacteria

    Science.gov (United States)

    Butaye, Patrick; Devriese, Luc A.; Haesebrouck, Freddy

    2003-01-01

    There are not many data available on antibiotics used solely in animals and almost exclusively for growth promotion. These products include bambermycin, avilamycin, efrotomycin, and the ionophore antibiotics (monensin, salinomycin, narasin, and lasalocid). Information is also scarce for bacitracin used only marginally in human and veterinary medicine and for streptogramin antibiotics. The mechanisms of action of and resistance mechanisms against these antibiotics are described. Special emphasis is given to the prevalence of resistance among gram-positive bacteria isolated from animals and humans. Since no susceptibility breakpoints are available for most of the antibiotics discussed, an alternative approach to the interpretation of MICs is presented. Also, some pharmacokinetic data and information on the influence of these products on the intestinal flora are presented. PMID:12692092

  6. Antimicrobial Growth Promoters Used in Animal Feed: Effects of Less Well Known Antibiotics on Gram-Positive Bacteria

    OpenAIRE

    Butaye, Patrick; Devriese, Luc A.; Haesebrouck, Freddy

    2003-01-01

    There are not many data available on antibiotics used solely in animals and almost exclusively for growth promotion. These products include bambermycin, avilamycin, efrotomycin, and the ionophore antibiotics (monensin, salinomycin, narasin, and lasalocid). Information is also scarce for bacitracin used only marginally in human and veterinary medicine and for streptogramin antibiotics. The mechanisms of action of and resistance mechanisms against these antibiotics are described. Special emphas...

  7. Not well known and long time been lost sight of. The great accidents of uranium hexafluoride in the world

    International Nuclear Information System (INIS)

    This issue reports the accident of uranium hexafluoride leak occurred at Pierrelatte on the 1. july 1977. A container with U F6 was handled to be stored before to be shifted. The gate broke and the liquid U F6 was thrown out under the pressure of gaseous U F6. A white very opaque cloud was formed. It was composed of hydrofluoric acid (HF) and crystals of uranium oxyfluoride (UO2F2). The cloud spread on 1800 meters and became invisible after several kilometers. The fallout was followed as far as Avignon with a maximum of HF pollution of 82 micrograms by cubic metre. The measurement of uranium in urines of working personnel showed that for 320 persons (on 420 workers) the results were not null. Three persons were sent at hospital for kidney surveillance but fortunately without consequences. This accident allowed in less than one month to get major improvements that years of administrative procedures did not get. (N.C.)

  8. Compiling some well-known anomalies of granular superconductors and recognizing their innate dependence on sample preparation and processing

    Science.gov (United States)

    Passos, W. A. C.; Lisboa-Filho, P. N.; de Andrade, R.; Salama, K.; Ortiz, W. A.

    2002-07-01

    Following a recent paper reviewing the current understanding of the most common anomalies exhibited by superconductors, the present contribution reports some recent results which further demonstrate that, in good-quality melt-textured samples, the fishtail anomaly becomes experimentally accessible as the granularity generated by oxygen deficiency is decreased by re-oxygenation of the samples.

  9. Comparing emergy accounting with well-known sustainability metrics: The case of Southern Cone Common Market, Mercosur

    International Nuclear Information System (INIS)

    The quality and the power of human activities affect the external environment in different ways that can be measured and evaluated by means of several approaches and indicators. While the scientific community has been publishing several proposals for sustainable development indicators, there is still no consensus regarding the best approach to the use of these indicators and their reliability to measure sustainability. It is important, therefore, to question the effectiveness of sustainable development indicators in an effort to continue in the search for sustainability. This paper compares the results obtained with emergy accounting with five global Sustainability Metrics (SMs) proposed in the literature to verify if metrics are communicating coherent and similar information to guide decision makers towards sustainable development. Results obtained using emergy indices are discussed with the aid of emergy ternary diagrams. Metrics are confronted with emergy results, and the degree of variability among them is analyzed using a correlation matrix created for the Mercosur nations. The contrast of results clearly shows that metrics arrive at different interpretations about the sustainability of the nations studied, but also that some metrics may be grouped and used more prudently. Mercosur is presented as a case study to highlight and explain the discrepancies and similarities among Sustainability Metrics, and to expose the extent of emergy accounting.

  10. Zinc-responsive acral hyperkeratotic dermatosis-A novel entity or a subset of some well-known dermatosis?

    Directory of Open Access Journals (Sweden)

    Arghyaprasun Ghosh

    2015-01-01

    Full Text Available Background: We are reporting a series of interesting cases, which presented to us with psoriasiform lesions distributed over the acral regions of the body. The cases are unusual because they were resistant to conventional treatment modalities like topical corticosteroids, tacrolimus and oral methotrexate but showed significant improvement on oral zinc therapy. Materials and Methods: Ten patients with characteristic clinical features of distinctive hyperkeratotic plaque in the acral areas, who were resistant to treatment by different modalities including potent topical steroids and oral methotrexate, were included for detailed investigations. A proper history was taken and relevant laboratory investigations were done which included blood count, urine, liver function, renal function, hepatitis-C virus serology and serum zinc levels. Patients were followed up every 2 weeks. Histopathological examinations of the lesional tissue were done at baseline and after 6 weeks of therapy. Patients were given oral zinc daily and no other treatment during the 6 weeks course. Results: All our patients were non-reactive to hepatitis-C. Of the ten patients only one patient (10% showed low titer of serum zinc, another (10% showed higher zinc level, while the rest of the patients had normal zinc level. Five of our patients had chronic renal failure, one had Grave′s disease and the remaining had no associated systemic illness. Histopathology mostly showed hyperkeratosis, acanthosis, prominent granular layer, spongiosis and dermal infiltrate. After 6 weeks of follow up, all patients showed rapid and remarkable therapeutic response with zinc. Conclusions: We here report a series of patients, discernible because of their uniform clinical presentation of acral hypekeratotic plaques and in showing a noticeable response to zinc. Clinical, histopathological and laboratory investigations were done to rule out diseases of similar morphology including psoriasis, acral necrolytic erythema and lichen simplex chronicus. Authors understand that further studies with greater number cases and more detailed investigations are required to establish exact etio-pathogenesis and nomenclature of this distinct subset of patients.

  11. Gamma-enolase: a well-known tumour marker, with a less-known role in cancer

    International Nuclear Information System (INIS)

    Gamma-enolase, known also as neuron-specific enolase (NSE), is an enzyme of the glycolytic pathway, which is expressed predominantly in neurons and cells of the neuroendocrine system. As a tumour marker it is used in diagnosis and prognosis of cancer; however, the mechanisms enrolling it in malignant progression remain elusive. As a cytoplasmic enzyme gamma-enolase is involved in increased aerobic glycolysis, the main source of energy in cancer cells, supporting cell proliferation. However, different cellular localisation at pathophysiological conditions, proposes other cellular engagements. The C-terminal part of the molecule, which is not related to glycolytic pathway, was shown to promote survival of neuronal cells by regulating neuronal growth factor receptor dependent signalling pathways, resulting also in extensive actin cytoskeleton remodelling. This additional function could be important also in cancer cells either to protect cells from stressful conditions and therapeutic agents or to promote tumour cell migration and invasion. Gamma-enolase might therefore have a multifunctional role in cancer progression: it supports increased tumour cell metabolic demands, protects tumour cells from stressful conditions and promotes their invasion and migration

  12. Gamma-enolase: a well-known tumour marker, with a less-known role in cancer

    OpenAIRE

    Vizin Tjasa; Kos Janko

    2015-01-01

    Background. Gamma-enolase, known also as neuron-specific enolase (NSE), is an enzyme of the glycolytic pathway, which is expressed predominantly in neurons and cells of the neuroendocrine system. As a tumour marker it is used in diagnosis and prognosis of cancer; however, the mechanisms enrolling it in malignant progression remain elusive. As a cytoplasmic enzyme gamma-enolase is involved in increased aerobic glycolysis, the main source of energy in cancer cells, supporting cell proliferation...

  13. Research Areas: Clinical Trials

    Science.gov (United States)

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

  14. Clinical Trial Basics

    Science.gov (United States)

    ... of clinical research make a difference? What are clinical trials and why do people participate? Clinical trials ... treatments for others in the future. What is clinical research? Clinical research is medical research that involves ...

  15. What Are Clinical Trials?

    Science.gov (United States)

    Information covering the basics of cancer clinical trials, including what they are, where they take place, and the types of clinical trials. Also, explains phases, randomization, placebo, and members of the research team.

  16. Informed Consent (Clinical Trials)

    Science.gov (United States)

    ... Research Cancer Treatment Types of Treatment Side Effects Clinical Trials Information for Patients and Caregivers A to ... Staging Prognosis Treatment Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings ...

  17. Flexible manufacturing field trial

    OpenAIRE

    Cruz, Nuno; Gomes, Ricardo

    2009-01-01

    Within the European project R-Fieldbus (http://www.hurray.isep.ipp.pt/activities/rfieldbus/), an industrial manufacturing field trial was developed. This field trial was conceived as a demonstration test bed for the technologies developed during the project. Because the R-Fieldbus field trial included prototype hardware devices, the purpose of this equipment changed and since the conclusion of the project, several new technologies also emerged, therefore an update of the field trial was requi...

  18. Salem Witch Trials.

    Science.gov (United States)

    Ray, Benjamin

    2003-01-01

    Presents a lesson plan that focuses on the Salem (Massachusetts) witchcraft trials. Explains that the first section of the lesson has students learn about the trials as described in the court records. The second section asks students to interpret various images of the trials. (CMK)

  19. Clinical Trials for Dry AMD

    Science.gov (United States)

    ... Degeneration? / Dry AMD / Clinical Trials For Dry AMD Clinical Trials For Dry AMD Listen Clinical trials are the final research phase before a ... is testing in humans through a succession of clinical trials. Research on treatments starts in the laboratory ...

  20. Clinical Trials in Vision Research

    Science.gov (United States)

    ... Research at NEI Education Programs Training and Jobs Clinical Trials in Vision Research Listen Clinical studies depend ... vision research in the United States. Basics of Clinical Trials What is a clinical trial? Clinical trials ...

  1. Clinical Trials for Wet AMD

    Science.gov (United States)

    ... Browse: Home / Research / Clinical Trials For Wet AMD Clinical Trials For Wet AMD Listen Clinical trials are the final research phase before a ... is testing in humans through a succession of clinical trials. Research on treatments starts in the laboratory ...

  2. AIDS Clinical Trials Group Network

    Science.gov (United States)

    ... Center Statistical and Data Management Center Glossaries Sites Clinical Trials About the Trial Process Trials Open to Enrollment Layman’s Study Summaries Access to Published Data Clinical Trials Resources Committees Executive Scientific Resource Community General ...

  3. Understanding noninferiority trials

    Directory of Open Access Journals (Sweden)

    Seokyung Hahn

    2012-11-01

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

  4. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P; Christensen, I; Denis, L

    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...

  5. The FOCUS trial

    DEFF Research Database (Denmark)

    Glenthøj, Louise B; Fagerlund, Birgitte; Randers, Lasse; Hjorthøj, Carsten R; Wenneberg, Christina; Krakauer, Kristine; Vosgerau, Astrid; Gluud, Christian; Medalia, Alice; Roberts, David L; Nordentoft, Merete

    2015-01-01

    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.MethodsThe FOCUS trial (Function and Overall Cognition in Ultra-high risk States) is a randomised, parallel group, observer-blinded clinical.......DiscussionThis is the first trial to evaluate the effects of neurocognitive and social cognitive remediation in UHR patients. The FOCUS trial results will provide evidence on the effect of targeted and comprehensive cognitive rehabilitation on cognition, daily living, and symptomatology as well as long-term outcome...

  6. Preventing knee injuries in adolescent female football players – design of a cluster randomized controlled trial [NCT00894595

    OpenAIRE

    Waldén Markus; Hägglund Martin; Atroshi Isam

    2009-01-01

    Abstract Background Knee injuries in football are common regardless of age, gender or playing level, but adolescent females seem to have the highest risk. The consequences after severe knee injury, for example anterior cruciate ligament (ACL) injury, are well-known, but less is known about knee injury prevention. We have designed a cluster randomized controlled trial (RCT) to evaluate the effect of a warm-up program aimed at preventing acute knee injury in adolescent female football. Methods ...

  7. Clinical trial structures

    OpenAIRE

    Evans, Scott R

    2010-01-01

    Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is crucial. The selection of a clinical trial design structure requires logic and creativity. Common structural designs are discussed.

  8. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P; Christensen, I; Denis, L

    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...

  9. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  10. HIV/AIDS Clinical Trials

    Science.gov (United States)

    ... APIs Widgets Order Publications Skip Nav HIV/AIDS Clinical Trials Home > Clinical Trials Español Text Size Use ... Vaccine Research HIV Preventive Vaccines HIV Therapeutic Vaccines Clinical Trial News Friday, March 18, 2016 AIDS-Kaposi’s ...

  11. 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 ...

  12. Update on TROG trials

    International Nuclear Information System (INIS)

    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

  13. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  14. Anchor Trial Launch

    Science.gov (United States)

    NCI has launched a multicenter phase III clinical trial called the ANCHOR Study -- Anal Cancer HSIL (High-grade Squamous Intraepithelial Lesion) Outcomes Research Study -- to determine if treatment of HSIL in HIV-infected individuals can prevent anal canc

  15. Who's in Clinical Trials?

    Science.gov (United States)

    ... Consumers Home For Consumers Consumer Updates Who's in Clinical Trials? Share Tweet Linkedin Pin it More sharing ... it very helpful.” back to top Designing Better Clinical Studies Beyond transparency, FDA hopes this initiative will ...

  16. Polyp Prevention Trial

    Science.gov (United States)

    The primary objective of the Polyp Prevention Trial (PPT) is to determine whether a low fat, high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous polyps of the large bowel.

  17. Clinical Trials - Participants

    Science.gov (United States)

    ... principal investigator (PI), who is often a doctor. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness. IRB review Most, but not all, clinical trials in the ...

  18. Narrating the Mensalão trial

    DEFF Research Database (Denmark)

    Damgaard, Mads

    2015-01-01

    Coming to a close in the last days of 2012, the trial of the so-called mensalão network was heralded as Brazil's trial of the century. Involving corruption in the top ranks of the business world and the former government, the process ended with an exceptional result in the sense that severe...... sentences were meted out to 25 of the 38 defendants, thereby breaking an established pattern of impunity for corrupt politicians in Brazilian courts. As a scandal potentially harmful for the governing party and the former president Luis “Lula” da Silva, the eyes and spotlights of the national media were...... fixed on the trial. However, the varying and contested ways in which the case was presented by media from the outbreak of the scandal in 2005 until the end of the trial bears witness to the fact that narratives concerning corruption scandals can potentially encompass a broad range of political and...

  19. The ONTARGET trial programme

    DEFF Research Database (Denmark)

    Unger, Thomas; Kintscher, Ulrich; Kappert, Kai; Steckelings, Ulrike M.

    2009-01-01

    The ONTARGET trial programme tested the effects of the angiotensin AT1 receptor blocker (ARB), telmisartan, alone or in combination with the angiotensin converting enzyme (ACE) inhibitor, ramipril, in more than 25.000 patients at high cardiovascular risk including diabetes on a combined endpoint consisting of cardiovascular death, non-fatal stroke or myocardial infarction and hospitalisation for congestive heart failure. Patient selection and study procedures followed the previous HOPE trial. In...

  20. Orthopaedic trial networks.

    OpenAIRE

    Rangan, A.; Brealey, S; Carr, A.

    2012-01-01

    Randomized controlled trials (RCTs) are considered the most robust design for evaluating health care interventions. However, it is difficult to acquire funding for RCTs, and they are complex to set up. Threats to their successful conduct and impact on clinical practice, particularly in surgical trials, include problems with recruitment, notably in terms of clinical equipoise and patient acceptability. Historically, RCTs are less common in surgical specialties, and their contribution to the or...

  1. The FOCUS trial

    DEFF Research Database (Denmark)

    Glenthøj, Louise B; Fagerlund, Birgitte; Randers, Lasse; Hjorthøj, Carsten R; Wenneberg, Christina; Krakauer, Kristine; Vosgerau, Astrid; Gluud, Christian; Medalia, Alice; Roberts, David L; Nordentoft, Merete

    2015-01-01

    BackgroundCognitive 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.MethodsThe FOCUS trial (Function and Overal...

  2. Fundamentals of clinical trial design

    OpenAIRE

    Evans, Scott R

    2010-01-01

    Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is crucial. Issues in trial conduct and analyses should be anticipated during trial design and thoughtfully addressed. Fundamental clinical trial design issues are discussed.

  3. Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

    Science.gov (United States)

    Dawson, Liza; Zwerski, Sheryl

    2015-06-01

    This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. PMID:25230397

  4. A Bayesian Approach to Surrogacy Assessment Using Principal Stratification in Clinical Trials

    OpenAIRE

    Li, Yun; Taylor, Jeremy M.G.; Elliott, Michael R.

    2009-01-01

    A surrogate marker (S) is a variable that can be measured earlier and often easier than the true endpoint (T) in a clinical trial. Most previous research has been devoted to developing surrogacy measures to quantify how well S can replace T or examining the use of S in predicting the effect of a treatment (Z). However, the research often requires one to fit models for the distribution of T given S and Z. It is well known that such models do not have causal interpretations because the models c...

  5. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.; Hunter, D. J.; Jiang, G.-L.; Skou, Søren Thorgaard; Wang, S.; Schnitzer, T.

    2015-01-01

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct, and...... reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After the...... index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations. In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials...

  6. Gateways to clinical trials.

    Science.gov (United States)

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

    2007-05-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issues focuses on the following selection of drugs: (-)-Epigallocatechin gallate, 101M, AAV-AADC, AGN-201904-Z; Agomelatine, AN-0128, AN-2690, Arginine butyrate, Asenapine maleate; Belinostat, Bortezomib, BQ-123, BQ-788; Bucindolol hydrochloride; Certolizumab pegol; Dasatinib, Denosumab, Desvenlafaxine succinate; Ecogramostim, Esomeprazole magnesium; Homoharringtonine; huN901-DM1, Hyaluronic acid; Incyclinide; L-Arginine hydrochloride; Mepolizumab; Nematode anticoagulant protein c2, Nilotinib; Oblimersen sodium; R-115866, Raltegravir potassium, Retapamulin, Romidepsin, Rusalatide acetate; Sarcosine, SCIO-469, Soblidotin, Sorivudine; Tilarginine hydrochloride, Tipifarnib; Uracil; Vildagliptin. PMID:17609744

  7. Narrating the Mensalão trial:

    DEFF Research Database (Denmark)

    Damgaard, Mads

    2015-01-01

    Coming to a close in the last days of 2012, the trial of the so-called mensalão network was heralded as Brazil's trial of the century. Involving corruption in the top ranks of the business world and the former government, the process ended with an exceptional result in the sense that severe sentences were meted out to 25 of the 38 defendants, thereby breaking an established pattern of impunity for corrupt politicians in Brazilian courts. As a scandal potentially harmful for the governing party a...

  8. The challenge of recruiting patients into a placebo-controlled surgical trial

    DEFF Research Database (Denmark)

    Hare, Kristoffer B; Lohmander, L Stefan

    2014-01-01

    BACKGROUND: Randomized placebo-controlled trials represent the gold standard in evaluating healthcare interventions but are rarely performed within orthopedics. Ethical concerns or well-known challenges in recruiting patients for surgical trials in general have been expressed and adding a placebo component only adds to this complexity. The purpose of this study was to report the challenges of recruiting patients into an orthopedic placebo-controlled surgical trial, to determine the number of patients needed to be screened and allocated in order to include one participant into the trial, and to identify reasons associated with participation in a placebo-controlled randomized surgical trial. METHODS: Data were extracted from an ongoing placebo-controlled randomized controlled trial (RCT) on meniscectomy versus placebo surgery. We calculated the number of patients needed to be screened in order to include the required number of participants into the RCT. Participating patients were asked about their rationale for joining the study and which type of information was most useful for deciding upon participation. RESULTS: A total of 476 patients entered the screening group, of which 190 patients fulfilled the inclusion and exclusion criteria. 102 patients declined to participate in the study due to various reasons and 46 were later excluded (no meniscus lesion on the magnetic resonance imaging scan or withdrawn consent). A total of 40 patients were finally included in the RCT. To include one patient into the RCT, 11.9 individuals needed to be screened. A total of 69% of participating patients considered the oral information to be the most important and the most common reason for participating was the contribution to research (90%). CONCLUSIONS: Patients are willing to participate in an orthopedic placebo-controlled surgical trial. Oral information given by the surgeon to the patient and the contribution to research are important aspects to enhance patient recruitment. TRIAL REGISTRATION: ClinicalTrials.gov NCT01264991, registered 21 December 2010.

  9. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.; Finch, C. F.; Bennell, K. L.; Story, B.; Spindler, K.; Kemp, J.; Lohmander, L. S.

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...

  10. Clinical Trials Guidelines

    Science.gov (United States)

    Consensus Recommendations for the Use of 18F-FDG PET as an Indicator of Therapeutic Response in Patients in National Cancer Institute Trials, Shankar LK, Hoffman JM, Bacharach S, Graham MM, et al. J Nucl Med (2006) 47:1059-1066. Print This Page Clinical

  11. The ONTARGET trial programme

    DEFF Research Database (Denmark)

    Unger, Thomas; Kintscher, Ulrich; Kappert, Kai; Steckelings, Ulrike M.

    2009-01-01

    The ONTARGET trial programme tested the effects of the angiotensin AT1 receptor blocker (ARB), telmisartan, alone or in combination with the angiotensin converting enzyme (ACE) inhibitor, ramipril, in more than 25.000 patients at high cardiovascular risk including diabetes on a combined endpoint ...

  12. Ensuring Participant Safety and Trial Integrity with Clinical Trials Oversight

    OpenAIRE

    Godfrey, Catherine; Payton, Manizhe; Tasker, Sybil; Proestel, Scott; Schouten, Jeffrey T

    2014-01-01

    Clinical trial oversight is a critical element that ensures the protection of research participants and integrity of the data collected. The trial sponsor, a local IRB and independent monitoring committees all contribute with complementary but overlapping responsibilities. Consistency among these groups is essential for the smooth conduct of a clinical trial, but may be challenging in resource-limited settings (RLS). Capacity building and training for RLS may improve clinical trials oversight...

  13. Intravenous Vitamin C administration reduces fatigue in office workers: a double-blind randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Suh Sang-Yeon

    2012-01-01

    Full Text Available Abstract Background Studies of the efficacy of vitamin C treatment for fatigue have yielded inconsistent results. One of the reasons for this inconsistency could be the difference in delivery routes. Therefore, we planned a clinical trial with intravenous vitamin C administration. Methods We evaluated the effect of intravenous vitamin C on fatigue in office workers. A group of 141 healthy volunteers, aged 20 to 49 years participated in this randomized, double-blind, controlled clinical trial. The trial group received 10 grams of vitamin C with normal saline intravenously, while the placebo group received normal saline only. Since vitamin C is a well-known antioxidant, oxidative stress was measured. Fatigue score, oxidative stress, and plasma vitamin C levels were measured before intervention, and again two hours and one day after intervention. Adverse events were monitored. Results The fatigue scores measured at two hours after intervention and one day after intervention were significantly different between the two groups (p = 0.004; fatigue scores decreased in the vitamin C group after two hours and remained lower for one day. Trial also led to higher plasma vitamin C levels and lower oxidative stress compared to the placebo group (p Conclusion Thus, intravenous vitamin C reduced fatigue at two hours, and the effect persisted for one day. There were no significant differences in adverse events between two groups. High dose intravenous vitamin C proved to be safe and effective against fatigue in this study. Trial Registration The clinical trial registration of this trial is http://ClinicalTrials.govNCT00633581.

  14. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.; Finch, C. F.; Bennell, K. L.; Story, B.; Spindler, K.; Kemp, J.; Lohmander, L. S.

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform the design, conduct and analytical approaches to RCTs evaluating the preventative effect of joint injury prevention strategies. Recommendations regarding the design, conduct, and reporting of RCTs evalu...

  15. Randomised clinical trial

    DEFF Research Database (Denmark)

    Meineche-Schmidt, V.; Christensen, E.; Bytzer, P.

    2011-01-01

    Background: Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable. Aim: To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment. Methods: Eight hundred and five uninvestigated, primary care patients with upper GI ....... Conclusions In patients with uninvestigated dyspepsia, PPI responders can be reliably identified by a simple pocket chart using symptoms and patient characteristics (ClinicalTrials.gov NCT00318968). © 2010 Blackwell Publishing Ltd....

  16. Randomised clinical trial

    DEFF Research Database (Denmark)

    Meineche-Schmidt, V.; Christensen, E.; Bytzer, P.

    2011-01-01

    Background: Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable. Aim: To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment. Methods: Eight hundred and five uninvestigated, primary care patients with upper GI ....... Conclusions In patients with uninvestigated dyspepsia, PPI responders can be reliably identified by a simple pocket chart using symptoms and patient characteristics (ClinicalTrials.gov NCT00318968). © 2010 Blackwell Publishing Ltd....

  17. NATO SOCMET trials

    Science.gov (United States)

    Jenden, C. M.

    1993-11-01

    During 1993, Canada, France, Germany and the United Kingdom will be participating in the Smoke and Obscurants Countermeasures Materials Evaluation Tests (SOCMET). The tests will be carried out under the auspices of the NATO Army Armaments Group, AC/225, Panel VI, Sub-Panel 7 whose interests include multispectral smoke screening systems. The tests will comprise two sets of trials; one under cold climate conditions in Quebec, Canada, during February/March 1993 and the other in temperate conditions in Bourges, France during September 1993. This paper provides an insight into the management and aims of SOCMET. The evaluations will be seeking to identify candidate materials which create effective obscurant screens in the visible, infrared and millimetric bands of the electromagnetic spectrum. These materials will be disseminated through a range area dispersal. A key element of the trials will be the evaluation of field test instrumentation which may eventually lead to the development of standardized evaluation techniques. Following the trials, a scientific workshop will be held to review the results. A final report will be presented to NATO which will form the basis of future collaborative developments on multispectral screening systems leading towards standard NATO documentation on smoke and obscurant systems.

  18. Ongoing activity in the optic tectum is correlated on a trial-by-trial basis with the pupil dilation response.

    Science.gov (United States)

    Netser, Shai; Dutta, Arkadeb; Gutfreund, Yoram

    2014-03-01

    The selection of the appropriate stimulus to induce an orienting response is a basic task thought to be partly achieved by tectal circuitry. Here we addressed the relationship between neural activity in the optic tectum (OT) and orienting behavioral responses. We recorded multiunit activity in the intermediate/deep layers of the OT of the barn owl simultaneously with pupil dilation responses (PDR, a well-known orienting response common to birds and mammals). A trial-by-trial analysis of the responses revealed that the PDR generally did not correlate with the evoked neural responses but significantly correlated with the rate of ongoing neural activity measured shortly before the stimulus. Following this finding, we characterized ongoing activity in the OT and showed that in the intermediate/deep layers it tended to fluctuate spontaneously. It is characterized by short periods of high ongoing activity during which the probability of a PDR to an auditory stimulus inside the receptive field is increased. These high-ongoing activity periods were correlated with increase in the power of gamma band local field potential oscillations. Through dual recordings, we showed that the correlation coefficients of ongoing activity decreased as a function of distance between recording sites in the tectal map. Significant correlations were also found between recording sites in the OT and the forebrain entopallium. Our results suggest that an increase of ongoing activity in the OT reflects an internal state during which coupling between sensory stimulation and behavioral responses increases. PMID:24304859

  19. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2010-12-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Thomson Reuters Integrity(SM), the drug discovery and development portal, http://www.thomsonreutersintegrity.com. This issue focuses on the following selection of drugs: 17-Hydroxyprogesterone caproate; Abacavir sulfate/lamivudine, Aclidinium bromide, Adalimumab, Adefovir, Alemtuzumab, Alkaline phosphatase, Amlodipine, Apilimod mesylate, Aripiprazole, Axitinib, Azacitidine; Belotecan hydrochloride, Berberine iodide, Bevacizumab, Bortezomib, Bosentan, Bryostatin 1; Calcipotriol/hydrocortisone, Carglumic acid, Certolizumab pegol, Cetuximab, Cinacalcet hydrochloride, Cixutumumab, Coumarin, Custirsen sodium; Darbepoetin alfa, Darifenacin hydrobromide, Darunavir, Dasatinib, Denibulin hydrochloride, Denosumab, Diacetylmorphine, Dulanermin, Duloxetine hydrochloride; Ecogramostim, Enfuvirtide, Entecavir, Enzastaurin hydrochloride, Eplerenone, Escitalopram oxalate, Esomeprazole sodium, Etravirine, Everolimus, Ezetimibe; Fenofibrate/pravastatin sodium, Ferric carboxymaltose, Flavangenol, Fondaparinux sodium; Glutamine, GSK-1024850A; Hepatitis B hyperimmunoglobulin, Hib-MenC, HIV-LIPO-5; Immunoglobulin intravenous (human), Indacaterol maleate, Indibulin, Indium 111 (¹¹¹In) ibritumomab tiuxetan, Influenza A (H1N1) 2009 Monovalent vaccine, Inhalable human insulin, Insulin glulisine; Lapatinib ditosylate, Leucovorin/UFT; Maraviroc, Mecasermin, MMR-V, Morphine hydrochloride, Morphine sulfate/naltrexone hydrochloride, Mycophenolic acid sodium salt; Naproxen/esomeprazole magnesium, Natalizumab; Oncolytic HSV; Paliperidone, PAN-811, Paroxetine, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b/ribavirin, Pegvisomant, Pemetrexed disodium, Pimecrolimus, Posaconazole, Pregabalin; Raltegravir potassium, Ranelic acid distrontium salt, Rasburicase, Rilpivirine hydrochloride; Sertindole, Sivelestat sodium hydrate, Sorafenib, Sumatriptan succinate/naproxen sodium, Sunitinib malate; Tafluprost, Telithromycin, Temsirolimus, Tenofovir disoproxil fumavate, Tenofovir disoproxil fumarate/emtricitabine, Teriparatide, Ticagrelor, Tigecycline, Tipranavir, Tirapazamine, Trimetrexate; Ulipristal acetate; Valganciclovir hydrochloride, Vicriviroc, Vorinostat; Yttrium 90 (90Y) ibritumomab tiuxetan. PMID:21225012

  20. Gateways to clinical trials.

    Science.gov (United States)

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

    2006-09-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com This issue focuses on the following selection of drugs: A-007, A6, adalimumab, adenosine triphosphate, alefacept, alemtuzumab, AllerVax Ragweed, amphora, anakinra, angiotensin-(1-7), anidulafungin, apomine, aripiprazole, atomoxetine hydrochloride, avanafil; BAL-8557, becatecarin, bevacizumab, biphasic insulin aspart, BMS-188797, bortezomib, bosentan, botulinum toxin type B, brivudine; Calcipotriol/betamethasone dipropionate, caspofungin acetate, catumaxomab, certolizumab pegol, cetuximab, CG-0070, ciclesonide, cinacalcet hydrochloride, clindamycin phosphate/benzoyl peroxide, cryptophycin 52, Cypher; Dabigatran etexilate, darapladib, darbepoetin alfa, decitabine, deferasirox, desloratadine, dexanabinol, dextromethorphan/quinidine sulfate, DMF, drotrecogin alfa (activated), duloxetine hydrochloride; E-7010, edaravone, efalizumab, emtricitabine, entecavir, eplerenone, erlotinib hydrochloride, escitalopram oxalate, estradiol valerate/dienogest, eszopiclone, exenatide, ezetimibe; Fondaparinux sodium, fulvestrant; Gefitinib, gestodene, GYKI-16084; Hyaluronic acid, hydralazine hydrochloride/isosorbide dinitrate; Imatinib mesylate, indiplon, insulin glargine; Juzen-taiho-to; Lamivudine/zidovudine/abacavir sulfate, L-arginine hydrochloride, lasofoxifene tartrate, L-BLP-25, lenalidomide, levocetirizine, levodopa/carbidopa/entacapone, lexatumumab, lidocaine/prilocaine, lubiprostone, lumiracoxib; MAb-14.18, mitoquidone; Natalizumab, neridronic acid, neuradiab; Olpadronic acid sodium salt, omalizumab; p53-DC vaccine, parathyroid hormone (human recombinant), peginterferon alfa-2a, peginterferon alfa-2b, pemetrexed disodium, perifosine, pimecrolimus, prasterone, prasugrel, PRO-2000, Pseudostat; R24, rasburicase, RHAMM R3 peptide, rilonacept, rosuvastatin calcium, rotavirus vaccine, rufinamide; Sabarubicin hydrochloride, SHL-749, sirolimus-eluting stent, SLx-2101, sodium butyrate, sorafenib, SU-6668; TachoSil, tadalafil, taxus, tegaserod maleate, telbivudine, tenofovir disoproxil fumarate, teriparatide, tetramethylpyrazine, teverelix, tiotropium bromide, tipifarnib, tirapazamine, tolvaptan, TransvaxTM hepatitis C vaccine, treprostinil sodium; Valganciclovir hydrochloride, valsartan/amlodipine, vandetanib, vardenafil hydrochloride hydrate, vatalanib succinate, veglin, voriconazole; Yttrium 90 (90Y) ibritumomab tiuxetan; Zileuton, zotarolimus, zotarolimus-eluting stent. PMID:17003851

  1. Gateways to clinical trials.

    Science.gov (United States)

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

    2003-12-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abetimus sodium, adalimumab, alefacept, alemtuzumab, almotriptan, AMGN-0007, anakinra, anti-CTLA-4 Mab, L-arginine hydrochloride, arzoxifene hydrochloride, astemizole, atazanavir sulfate, atlizumab; Belimumab, BG-9928, binodenoson, bosentan, botulinum toxin type B, bovine lactoferrin, BufferGel; Caspofungin acetate, ciclesonide,cilomilast, ciluprevir, clofarabine, CVT-3146; Darbepoetin alfa, desloratadine, diflomotecan, doripenem, dronedarone hydrochloride, drotrecogin alfa (activated), DT388-GM-CSF, duloxetine hydrochloride, E-5564, efalizumab, enfuvirtide, esomeprazole magnesium, estradiol acetate, ETC-642, exenatide, exisulind, ezetimib; Febuxostat; Gallium maltolate, ganirelix acetate, garenoxacin mesilate, gefitinib; H11, HuMax; IL-15, IDD-1, IGIV-C, imatinib mesylate, ISIS-14803, ITF-1697, ivabradine hydrochloride; KRN-5500; L-365260, levetiracetam, levosimendan, licofelone, linezolid, LJP-1082, lopinavir lumiracoxib; MCC-478, melatonin, morphine hydrochloride, morphine-6-glucuronide, moxidectin; N-Acetylcarnosine, natalizumab, NM-702, NNC-05-1869, NSC-703940; Ocinaplon OM-89, omalizumab, omeprazole/ sodium bicarbonate, OPC-28326, ospemifene; PEG-filgrastim peginterferon alfa-2a, pegsunercept, pirfenidone, pralmorelin, pregabalin; Recombinant glucagon-like peptide-1 (7-36) amide, repifermin, RSD-1235; S-8184, selodenoson, sodium dichloroacetate, suberanilohydroxamic acid; TAS-102, terfenadine, teriparatide, tipranavir troxacitabine; Ximelagatran; YM-337. PMID:14735233

  2. Gateways to Clinical Trials.

    Science.gov (United States)

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

    2002-09-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Adalimumab, aeroDose insulin inhaler, agomelatine, alendronic acid sodium salt, aliskiren fumarate, alteplase, amlodipine, aspirin, atazanavir; Bacillus Calmette-Guérin, basiliximab, BQ-788, bupropion hydrochloride; Cabergoline, caffeine citrate, carbamazepine, carvedilol, celecoxib, cyclosporine, clopidogrel hydrogensulfate, colestyramine; Dexamethasone, diclofenac sodium, digoxin, dipyridamole, docetaxel, dutasteride; Eletriptan, enfuvirtidie, eplerenone, ergotamine tartrate, esomeprazole magnesium, estramustine phosphate sodium; Finasteride, fluticasone propionate, fosinopril sodium; Ganciclovir, GBE-761-ONC, glatiramer acetate, gliclazide, granulocyte-CSF; Heparin sodium, human isophane insulin (pyr), Hydrochlorothiazide; Ibuprofen, inhaled insulin, interferon alfa, interferon beta-1a; Laminvudine, lansoprazole, lisinopril, lonafarnib, losartan potassium, lumiracoxib; MAb G250, meloxicam methotrexate, methylprednisolone aceponate, mitomycin, mycophenolate mofetil; Naproxen sodium, natalizumab, nelfinavir mesilate, nemifitide ditriflutate, nimesulide; Omalizumab, omapatrilat, omeprazole, oxybutynin chloride; Pantoprazole sodium, paracetamol, paroxetine, pentoxifylline, pergolide mesylate, permixon, phVEGF-A165, pramipexole hydrochloride, prasterone, prednisone, probucol, propiverine hydrochloride; Rabeprazole sodium, resiniferatoxin, risedronate sodium, risperidone, rofecoxib rosiglitazone maleate, ruboxistaurin mesilate hydrate; Selegiline transdermal system, sertraline, sildenafil citrate, streptokinase; Tadalafil, tamsulosin hydrochloride, technosphere/Insulin, tegaserod maleate, tenofovir disoproxil fumarate, testosterone heptanoate, testosterone undecanoate, tipifarnib, tolterodine tartrate, topiramate, troglitazone; Ursodeoxycholic acid; Valdecoxib, valsartan, vardenafil, venlafaxine hydrochloride, VX-745. PMID:12428432

  3. Quality Assurance for Clinical Trials

    OpenAIRE

    GeoffreyStephenIbbott; AnnetteHaworth; DavidScottFollowill

    2013-01-01

    Cooperative groups, of which the Radiation Therapy Oncology Group (RTOG) 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 QA offices that is is charged with assuring that participating institu...

  4. Japan nuclear ship sea trial

    International Nuclear Information System (INIS)

    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)

  5. Industrial demonstration trials

    International Nuclear Information System (INIS)

    Prototypes of the plant components, meeting the specifications set by the process and built by industrial firms in collaboration with the supervisor and the C.E.A., are subjected to trial runs on the UF6 test bench of the Pierrelatte testing zone. These items of equipment (diffuser, compressor, exchanger) are placed in an industrial operation context very similar to that of an enrichment plant. Their performance is measured within a broad region around the working point and their reliability observed over periods up to several tens of thousands of hours. Between 1969 and 1973 six industrial demonstration test benches have been built, marking the stages in the technical preparation of the 1973 file on the basis of which the decision of building was taken by Eurodif

  6. Vicarious trial and error.

    Science.gov (United States)

    Redish, A David

    2016-02-19

    When rats come to a decision point, they sometimes pause and look back and forth as if deliberating over the choice; at other times, they proceed as if they have already made their decision. In the 1930s, this pause-and-look behaviour was termed 'vicarious trial and error' (VTE), with the implication that the rat was 'thinking about the future'. The discovery in 2007 that the firing of hippocampal place cells gives rise to alternating representations of each of the potential path options in a serial manner during VTE suggested a possible neural mechanism that could underlie the representations of future outcomes. More-recent experiments examining VTE in rats suggest that there are direct parallels to human processes of deliberative decision making, working memory and mental time travel. PMID:26891625

  7. A Well-Known Lesion in An Unusual Location: Infantile Myofibroma of the Eyelid:A Case Report and Review of Literature

    Directory of Open Access Journals (Sweden)

    Fahimeh Asadi Amoli

    2010-12-01

    Full Text Available Myofibroma is a neoplasia of myofibroblasts that can be solitary or multiple and it is found most commonly in the head & neck region including scalp, forehead, parotid region and oral cavity. In the eyelid it is rarely reported. It has a benign course in the solitary form and fatal in its multiple form. A 4 month male infant referred to Farabi hospital -the referral center for eye diseases- with a 2 month history of a mass in his eyelid with gradual enlargement with no other complaints. The only abnormal physical finding was a 2.5 cm mass in the eyelid. This mass was excised and sent to the hospital pathology laboratory. When confronting a spindle cell lesion with a nodular or multinodular growth pattern which appears biphasic due to alteration of light and dark staining areas, the surgical pathologist should think to the possibility of myofibroma. Its pattern of growth and architecture rules out the other differential diagnoses like nodular fasciitis, fibrous histiocytoma, infantile fibromatosis, and peripheral primitive neuroectodermal tumor, mesenchymal chondrosarcoma, malignant hemangiopericytoma, juvenile fibrosarcoma and poorly differentiated synovial sarcoma. In difficult cases immunohistochemical staining is helpful that is Vimentin & Actin positivity & Desmin, CK, EMA & S100 negativity.

  8. The use of a new approach to prevention and therapy of acute arterial hypertension with complex of well-known drugs with vegetable glycosides (experimental study

    Directory of Open Access Journals (Sweden)

    T. G. Tolstikova

    2006-01-01

    Full Text Available Aim. To evaluate antihypertensive efficacy of nifedipine (N and nifedipine complex (NC in acute test in rats with adrenaline model of arterial hypertension.Material and methods. N is a conventional short acting formulation while NC is a new formulation of nifedipine in complex with glycyrrhizic acid. NC has an active substance 10 times less than N does in the same dose. Adrenaline which results in two times increase in blood pressure (BP during 4 min was administered as a single i.v. dose (0,03 mg/kg to normotensive unconscious male rats (body weight 190-220 g. NC and N were administered in the same dose (3,5 mg/kg before and after adrenaline administration. Systolic BP recovering time was assessed. BP level was measured with direct method in carotid artery.Results. NC and N decreased in systolic BP in normotensive rats by 26 and 30% respectively. NC and N administered before adrenaline administration resulted in systolic BP recovering time reduction to 94,4 and 79,7 s respectively, which are less than this in control (204,8 s, ?<0,001. Difference in time between NC and N is not significant (p<0,1. NC and N administered after adrenaline administration resulted in systolic BP recovering time reduction to 104,7 and 139 s respectively, which are also less than this in control (204,8 s, ?<0,001. Difference in time between NC and N in this model is also not significant (p<0,1.Conclusion. NC with contents of active substance 10 times less than in N showed antihypertensive efficacy similar with this in N. NC can be used for prevention and therapy of acute arterial hypertension.

  9. Evidence chain-based causality identification in herb-induced liver injury: exemplification of a well-known liver-restorative herb Polygonum multiflorum.

    Science.gov (United States)

    Wang, Jiabo; Ma, Zhijie; Niu, Ming; Zhu, Yun; Liang, Qingsheng; Zhao, Yanling; Song, Jingyuan; Bai, Zhaofang; Zhang, Yaming; Zhang, Ping; Li, Na; Meng, Yakun; Li, Qi; Qin, Lushan; Teng, Guangju; Cao, Junling; Li, Baosen; Chen, Shilin; Li, Yonggang; Zou, Zhengsheng; Zhou, Honghao; Xiao, Xiaohe

    2015-12-01

    Herbal medicines have recently been recognized as the second most common cause of drug-induced liver injury (DILI) in the United States. However, reliable methods to identify the DILI causality of some herbs, such as Heshouwu (dried root of Polygonum multiflorum), remain lacking. In this study, a total of 12 307 inpatients with liver dysfunction and 147 literature-reported cases of Heshouwu DILI were screened. A general algorithm indicated that only 22.5% (9/40) and 30.6% (45/147) of all hospitalization and literature case reports, respectively, demonstrate the high probability of DILI causality of Heshouwu. By contrast, 95% (19/20) of all cases prospectively investigated by pharmacognosy, phytochemistry, and metabolomic tests exhibited highly probable causality, including a patient who was previously incorrectly attributed and a case that was excluded from Heshouwu causality by pharmacognostic evidence. Toxin (heavy metals, pesticides, and mycotoxins) contamination was also excluded from Heshouwu DILI causality. The objectivity of these screening methods for Heshouwu DILI diagnosis addresses safety concerns regarding stilbene-containing herbal medicines and dietary supplements. PMID:26459430

  10. Exposing the secrets of two well-known Lactobacillus casei phages, J-1 and PL-1, by genomic and structural analysis.

    Science.gov (United States)

    Dieterle, Maria Eugenia; Bowman, Charles; Batthyany, Carlos; Lanzarotti, Esteban; Turjanski, Adrián; Hatfull, Graham; Piuri, Mariana

    2014-11-01

    Bacteriophage J-1 was isolated in 1965 from an abnormal fermentation of Yakult using Lactobacillus casei strain Shirota, and a related phage, PL-1, was subsequently recovered from a strain resistant to J-1. Complete genome sequencing shows that J-1 and PL-1 are almost identical, but PL-1 has a deletion of 1.9 kbp relative to J-1, resulting in the loss of four predicted gene products involved in immunity regulation. The structural proteins were identified by mass spectrometry analysis. Similarly to phage A2, two capsid proteins are generated by a translational frameshift and undergo proteolytic processing. The structure of gene product 16 (gp16), a putative tail protein, was modeled based on the crystal structure of baseplate distal tail proteins (Dit) that form the baseplate hub in other Siphoviridae. However, two regions of the C terminus of gp16 could not be modeled using this template. The first region accounts for the differences between J-1 and PL-1 gp16 and showed sequence similarity to carbohydrate-binding modules (CBMs). J-1 and PL-1 GFP-gp16 fusions bind specifically to Lactobacillus casei/paracasei cells, and the addition of l-rhamnose inhibits binding. J-1 gp16 exhibited a higher affinity than PL-1 gp16 for cell walls of L. casei ATCC 27139 in phage adsorption inhibition assays, in agreement with differential adsorption kinetics observed for both phages in this strain. The data presented here provide insights into how Lactobacillus phages interact with their hosts at the first steps of infection. PMID:25217012

  11. Exposing the Secrets of Two Well-Known Lactobacillus casei Phages, J-1 and PL-1, by Genomic and Structural Analysis

    OpenAIRE

    Dieterle, Maria Eugenia; Bowman, Charles; Batthyany, Carlos; Lanzarotti, Esteban; Turjanski, Adrián; Hatfull, Graham; Piuri, Mariana

    2014-01-01

    Bacteriophage J-1 was isolated in 1965 from an abnormal fermentation of Yakult using Lactobacillus casei strain Shirota, and a related phage, PL-1, was subsequently recovered from a strain resistant to J-1. Complete genome sequencing shows that J-1 and PL-1 are almost identical, but PL-1 has a deletion of 1.9 kbp relative to J-1, resulting in the loss of four predicted gene products involved in immunity regulation. The structural proteins were identified by mass spectrometry analysis. Similar...

  12. Review of the chronic exposure pathways models in MACCS (MELCOR Accident Consequence Code System) and several other well-known probabilistic risk assessment models

    Energy Technology Data Exchange (ETDEWEB)

    Tveten, U. (Institutt for Energiteknikk, Kjeller (Norway))

    1990-06-01

    The purpose of this report is to document the results of the work performed by the author in connection with the following task, performed for US Nuclear Regulatory Commission, (USNRC) Office of Nuclear Regulatory Research, Division of Systems Research: MACCS Chronic Exposure Pathway Models: Review the chronic exposure pathway models implemented in the MELCOR Accident Consequence Code System (MACCS) and compare those models to the chronic exposure pathway models implemented in similar codes developed in countries that are members of the OECD. The chronic exposures concerned are via: the terrestrial food pathways, the water pathways, the long-term groundshine pathway, and the inhalation of resuspended radionuclides pathway. The USNRC has indicated during discussions of the task that the major effort should be spent on the terrestrial food pathways. There is one chapter for each of the categories of chronic exposure pathways listed above.

  13. Review of the chronic exposure pathways models in MACCS [MELCOR Accident Consequence Code System] and several other well-known probabilistic risk assessment models

    International Nuclear Information System (INIS)

    The purpose of this report is to document the results of the work performed by the author in connection with the following task, performed for US Nuclear Regulatory Commission, (USNRC) Office of Nuclear Regulatory Research, Division of Systems Research: MACCS Chronic Exposure Pathway Models: Review the chronic exposure pathway models implemented in the MELCOR Accident Consequence Code System (MACCS) and compare those models to the chronic exposure pathway models implemented in similar codes developed in countries that are members of the OECD. The chronic exposures concerned are via: the terrestrial food pathways, the water pathways, the long-term groundshine pathway, and the inhalation of resuspended radionuclides pathway. The USNRC has indicated during discussions of the task that the major effort should be spent on the terrestrial food pathways. There is one chapter for each of the categories of chronic exposure pathways listed above

  14. Evidence of phytohormones and phenolic acids variability in garden-waste-derived vermicompost leachate, a well-known plant growth stimulant

    OpenAIRE

    Aremu, A.O.; Stirk, W. A.; Kulkarni, M. G.; Tarkowská, D. (Danuše); Ture?ková, V. (Veronika); Grúz, J. (Ji?í); Šubrtová, M. (Michaela); P?n?ík, A. (Aleš); Novák, O.; Doležal, K. (Karel); Strnad, M.; van Staden, J.

    2015-01-01

    Cytokinins, auxins, abscisic acid, gibberellins (GAs) and brassinosteroids (BRs) as well as the phenolic acid content in three batches of vermicompost leachate (VCL) were quantified using ultra high performance liquid chromatography-tandem mass spectrometry. N (6)-isopentenyladenine formed the major (60 %) proportion of the CK content while dihydrozeatin had the lowest (< 0.02 %) concentration. Indole-3-acetic acid ranged from approximately 0.55-0.77 pmol/mL. A total of 18 GAs including bioac...

  15. Well known outstanding geoid and relief depressions as regular wave woven features on Eartg (Indian geoid minimum), Moon (SPA basin), Phobos (Stickney crater), and Miranda (an ovoid).

    Science.gov (United States)

    Kochemasov, Gennady G.

    2010-05-01

    A very unreliable interpretation of the deepest and large depressions on the Moon and Phobos as the impact features is not synonymous and causes many questions. A real scientific understanding of their origin should take into consideration a fact of their similar tectonic position with that of a comparable depression on so different by size, composition, and density heavenly body as Earth. On Earth as on other celestial bodies there is a fundamental division on two segments - hemispheres produced by an interference of standing warping wave 1 (long 2?R) of four directions [1]. One hemisphere is uplifted (continental, highlands) and the opposite subsided (oceanic, lowlands). Tectonic features made by wave 2 (sectors) adorn this fundamental structure. Thus, on the continental risen segment appear regularly disposed sectors, also uplifted and subsided. On the Earth's eastern continental hemisphere they are grouped around the Pamirs-Hindukush vertex of the structural octahedron made by interfering waves2. Two risen sectors (highly uplifted African and the opposite uplifted Asian) are separated by two fallen sectors (subsided Eurasian and the opposite deeply subsided Indoceanic). The Indoceanic sector with superposed on it subsided Indian tectonic granule (?R/4-structure) produce the deepest geoid minimum of Earth (-112 m). The Moon demonstrates its own geoid minimum of the same relative size and in the similar sectoral tectonic position - the SPA basin [2, 3]. This basin represents a deeply subsided sector of the sectoral structure around the Mare Orientale (one of vertices of the lunar structural octahedron). To this Mare converge four sectors: two subsided - SPA basin and the opposite Procellarum Ocean, and two uplifted - we call them the "Africanda sector" and the opposite "Antiafricanda one" to stress structural similarity with Earth [2]. The highest "Africanda sector" is built with light anorthosites; enrichment with Na makes them even less dense that is required by the sector highest elevation. Procellarum Ocean is filled with basalts and Ti-basalts. The SPA basin must be filled with even denser rocks. One expects here feldspar-free, pyroxene enriched rocks with some admixture of Fe metal and troilite. The spectral observations of Carle Pieters [4] confirm orthopyroxene enrichment and absence of feldspar. Enigmatic large and deep depression of crater Stickney on Phobos with an appropriate scale adjustment to much larger Earth and Moon occupies a similar structural position to the Indian geoid minimum and the SPA basin. Such situation cannot be random and proves a common origin of these remarkable tectonic features at so different celestial bodies. This conclusion is reinforced by taking for a comparison another small heavenly body- Uranus satellite Miranda. Imaged by Voyager 2 spacecraft in 1986 it shows two kinds of terrains (PIA01980 & others). Subsided provinces (ovoids) characterized by intensive curvilinear folding and faulting interrupt uplifted densely cratered old provinces. One of the deeply subsided ovoids with curvilinear folds pattern (compression under subsidence) perfectly fits into a sector boundary. References: [1] Kochemasov G. (1999) Theorems of wave planetary tectonics // Geophys. Res. Abstr., V.1, #3, 700. [2] Kochemasov G.G. (1998) The Moon: Earth-type sectoral tectonics, relief and relevant chemical features // The 3rd International Confernce on Exploration and Utilization of the Moon, Oct. 11-14, 1998, Moscow, Russia, Abstracts, p. 29. [3] Kochemasov G.G. (1998) Moon-Earth: similarity of sectoral organization // 32nd COSPAR Scientific Assembly, Nagoya, Japan, 12-19 July 1998, Abstracts, p. 77. [4] Pieters C. (1997) Annales Geophys., v. 15, pt. III, p. 792.

  16. 17 CFR 230.163 - Exemption from section 5(c) of the Act for certain communications by or on behalf of well-known...

    Science.gov (United States)

    2010-04-01

    ...section for such written communication that is an offer shall be...Legend. (i) Every written communication that is an offer made in...the offering to which this communication relates. Before you invest...visiting EDGAR on the SEC Web site at...

  17. Gypsy moth revisited : studies on the natural enemy complex of Lymantria dispar L. (Lep., Lymantriidae) during an outbreak in a well known gypsy moth area

    OpenAIRE

    Hoch, Gernot; Kalbacher, Georg; Schopf, Axel

    2008-01-01

    We have been surveying a gypsy moth, Lymantria dispar (Lep., Lymantriidae), population in the oak forest of Klingenbach near Eisenstadt, Austria, since 1992. During the last gradation from 1993 to 1996, we studied the natural enemy complex at this site in comparison with other locations where no outbreak occurred (HOCH et al. 2001). During the latency years, an experimental study on the impact of predators on L. dispar pupal populations was performed (GSCHWANTNER et al. 2002). The population ...

  18. Carbon nitride, a well-known substance. Production of H2 from light; Kohlenstoffnitrid - ein alter Bekannter. H{sub 2}-Herstellung durch Lichteinstrahlung

    Energy Technology Data Exchange (ETDEWEB)

    Wang, Xinchen [Max-Planck-Institut fuer Kolloid - und Grenzflaechenforschung, Potsdam (Germany)

    2009-04-15

    H2 production from water with the aid of solar energy and catalysts requires no fossil fuels and is an ideal energy source for the future. For an economically efficient utilisation of water and solar energy, catalysts are required that are efficient, stable, inexpensive, and which react to light. Carbon nitride is a polymer which produces hydrogen when exposed to visible light in the presence of an electron donor. In contrast to other semiconductors, carbon nitride is chemically and thermally stable and easy to produce. It will mark an important step in the direction of photosynthesis. (orig.)

  19. Evidence of phytohormones and phenolic acids variability in garden-waste-derived vermicompost leachate, a well-known plant growth stimulant.

    Czech Academy of Sciences Publication Activity Database

    Aremu, A.O.; Stirk, W.A.; Kulkarni, M. G.; Tarkowská, Danuše; Ture?ková, Veronika; Grúz, Ji?í; Šubrtová, Michaela; P?n?ík, Aleš; Novák, Ond?ej; Doležal, Karel; Strnad, Miroslav; van Staden, J.

    2015-01-01

    Ro?. 75, ?. 2 (2015), s. 483-492. ISSN 0167-6903 R&D Projects: GA MŠk LK21306; GA ?R GA14-34792S; GA MŠk(CZ) LO1204 Institutional support: RVO:61389030 Keywords : Abscisic acid * Biostimulant * Brassinosteroids Subject RIV: EB - Genetics ; Molecular Biology Impact factor: 1.672, year: 2014

  20. Novel PI3K/AKT targeting anti-angiogenic activities of 4-vinylphenol, a new therapeutic potential of a well-known styrene metabolite

    Science.gov (United States)

    Yue, Grace Gar-Lee; Lee, Julia Kin-Ming; Kwok, Hin-Fai; Cheng, Ling; Wong, Eric Chun-Wai; Jiang, Lei; Yu, Hua; Leung, Hoi-Wing; Wong, Yuk-Lau; Leung, Ping-Chung; Fung, Kwok-Pui; Lau, Clara Bik-San

    2015-01-01

    The pneumo- and hepato-toxicity of 4-vinylphenol (4VP), a styrene metabolite, has been previously reported. Nevertheless, the present study reported the novel anti-angiogenic activities of 4VP which was firstly isolated from the aqueous extract of a Chinese medicinal herb Hedyotis diffusa. Our results showed that 4VP at non-toxic dose effectively suppressed migration, tube formation, adhesion to extracellular matrix proteins, as well as protein and mRNA expressions of metalloproteinase-2 of human endothelial cells (HUVEC and HMEC-1). Investigation of the signal transduction revealed that 4VP down-regulated PI3K/AKT and p38 MAPK. Besides, 4VP interfered with the phosphorylation of ERK1/2, the translocation and expression of NFkappaB. In zebrafish embryo model, the new blood vessel growth was significantly blocked by 4VP (6.25–12.5??g/mL medium). The VEGF-induced blood vessel formation in Matrigel plugs in C57BL/6 mice was suppressed by 4VP (20–100??g/mL matrigel). In addition, the blood vessel number and tumor size were reduced by intraperitoneal 4VP (0.2–2?mg/kg) in 4T1 breast tumor-bearing BALB/c mice, with doxorubicin as positive control. Together, the in vitro and in vivo anti-angiogenic activities of 4VP were demonstrated for the first time. These findings suggest that 4VP has great potential to be further developed as an anti-angiogenic agent. PMID:26053458

  1. 95 years anniversary of Professor BL Kashcheyev (1920 - 2004) - the well-known Ukrainian researcher of meteors by the radar method

    Science.gov (United States)

    Kolomiyets, Svitlana

    2015-08-01

    Meteor astronomy is constantly evolving. We can distinguish several stages in the development of meteor astronomy. One of these steps is the period associated with carrying out the global program called "International Geophysical Year 1957" (IGY1957). Thanks to this program in Ukraine in Kharkiv has been studied meteors using radar techniques. One of the organizers of the IGY 1957 meteor program execution in Ukraine (and in the former Soviet Union) was prof. BL Kashcheyev (1920-2004). At the IAU GA in 1958 prof. BL Kashcheyev made the report on the meteor radar studies in Kharkiv. These research were considered by the IAU Commission 22 as the best in the world. The name of Professor BL Kashcheyev related to the creation of the Kharkiv meteor radar system and the long series of meteor observations, creating the database of 250 thousand orbits of faint meteors (12^ M), carrying out the variety of meteor projects (including the GLOBMET). In 2004 the Kharkiv meteor radar complex was given the status of national heritage of Ukraine. In 2007, the organizers of the program "International Heliophisic Year 2007" (IHY2007) remarked the BL Kashcheyev contribution to the IGY 1957 (the certificate and the pin "The IGY1957 Gold ").

  2. Patient Safety in Clinical Trials

    Science.gov (United States)

    Information for patients, their families and friends, and the general public about how the rights and safety of people who take part in clinical trials are protected. Learn about informed consent, institutional review boards (IRB's), and how trials are closely monitored for safety.

  3. Defendants' Rights in Criminal Trials.

    Science.gov (United States)

    Martin, Ralph C., II; Keeley, Elizabeth

    1997-01-01

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

  4. Clinical Research and Clinical Trials

    Science.gov (United States)

    ... Research Clinical Trials & Clinical Research Skip sharing on social media links Share this: Page Content Clinical research is research that directly involves a particular person or group of people, or that uses materials from humans, such as their behavior or samples of their tissue. A clinical trial ...

  5. Dramatization of Salem Witch Trial.

    Science.gov (United States)

    Chorak, Elizabeth

    1988-01-01

    Presents a lesson which can provide elementary students with an opportunity to compare fair and unfair trials. Stating that the lesson works best if an attorney is used as a resource person, the plan includes a short play about a Salem, Massachusetts witch trial and follow-up questions to stimulate student discussion. (GEA)

  6. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998...

  7. Complying with the European Clinical Trials directive while surviving the administrative pressure : An alternative approach to toxicity registration in a cancer trial

    DEFF Research Database (Denmark)

    Frandsen, Thomas Leth; Heyman, Mats

    2014-01-01

    The European Clinical Trials Directive of 2004 has increased the amount of paper work and reduced the number of initiated clinical trials. Particularly multinational trials have been delayed. To meet this challenge we developed a novel, simplified, fast and easy strategy for on-line toxicity registration for patients treated according to the Nordic/Baltic acute lymphoblastic leukaemia protocol, NOPHO ALL 2008, for children and young adults, including three randomisations. We used a risk-assessment based approach, avoiding reporting of expected adverse events and instead concentrating on 20 well-known serious, but rarer events with focus on changes in therapy introduced in the treatment protocol. This toxicity registration strategy was approved by the relevant regulatory authorities in all seven countries involved, as compliant within the EU directive of 2004. The centre compliance to registration was excellent with 98.9% of all patients being registered within 5weeks from the requested quarterly registration. Currently, four toxicities (thrombosis, fungal infections, pancreatitis and allergic reactions) have been chosen for further detailed exploration due to the cumulative fraction of patients with positive registrations exceeding 5%. This toxicity registration offers real-time toxicity profiles of the total study cohort and provides early warnings of specific toxicities that require further investigation.

  8. Complying with the European Clinical Trials directive while surviving the administrative pressure - an alternative approach to toxicity registration in a cancer trial

    DEFF Research Database (Denmark)

    Frandsen, Thomas Leth; Heyman, Mats

    2014-01-01

    The European Clinical Trials Directive of 2004 has increased the amount of paper work and reduced the number of initiated clinical trials. Particularly multinational trials have been delayed. To meet this challenge we developed a novel, simplified, fast and easy strategy for on-line toxicity registration for patients treated according to the Nordic/Baltic acute lymphoblastic leukaemia protocol, NOPHO ALL 2008, for children and young adults, including three randomisations. We used a risk-assessment based approach, avoiding reporting of expected adverse events and instead concentrating on 20 well-known serious, but rarer events with focus on changes in therapy introduced in the treatment protocol. This toxicity registration strategy was approved by the relevant regulatory authorities in all seven countries involved, as compliant within the EU directive of 2004. The centre compliance to registration was excellent with 98.9% of all patients being registered within 5weeks from the requested quarterly registration.Currently, four toxicities (thrombosis, fungal infections, pancreatitis and allergic reactions) have been chosen for further detailed exploration due to the cumulative fraction of patients with positive registrations exceeding 5%. This toxicity registration offers real-time toxicity profiles of the total study cohort and provides early warnings of specific toxicities that require further investigation.

  9. Complying with the European Clinical Trials directive while surviving the administrative pressure - an alternative approach to toxicity registration in a cancer trial.

    Science.gov (United States)

    Frandsen, Thomas Leth; Heyman, Mats; Abrahamsson, Jonas; Vettenranta, Kim; Åsberg, Ann; Vaitkeviciene, Goda; Pruunsild, Kaie; Toft, Nina; Birgens, Henrik; Hallböök, Helena; Quist-Paulsen, Petter; Griškevi?ius, Laimonas; Helt, Louise; Hansen, Birgitte Vilsbøll; Schmiegelow, Kjeld

    2014-01-01

    The European Clinical Trials Directive of 2004 has increased the amount of paper work and reduced the number of initiated clinical trials. Particularly multinational trials have been delayed. To meet this challenge we developed a novel, simplified, fast and easy strategy for on-line toxicity registration for patients treated according to the Nordic/Baltic acute lymphoblastic leukaemia protocol, NOPHO ALL 2008, for children and young adults, including three randomisations. We used a risk-assessment based approach, avoiding reporting of expected adverse events and instead concentrating on 20 well-known serious, but rarer events with focus on changes in therapy introduced in the treatment protocol. This toxicity registration strategy was approved by the relevant regulatory authorities in all seven countries involved, as compliant within the EU directive of 2004. The centre compliance to registration was excellent with 98.9% of all patients being registered within 5weeks from the requested quarterly registration. Currently, four toxicities (thrombosis, fungal infections, pancreatitis and allergic reactions) have been chosen for further detailed exploration due to the cumulative fraction of patients with positive registrations exceeding 5%. This toxicity registration offers real-time toxicity profiles of the total study cohort and provides early warnings of specific toxicities that require further investigation. PMID:24231337

  10. Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    Information about actively enrolling, ongoing, and completed clinical trials of cancer prevention, early detection, and supportive care, including phase I, II, and III agent and action trials and clinical trials management. |

  11. Frailty Intervention Trial (FIT

    Directory of Open Access Journals (Sweden)

    Lockwood Keri

    2008-10-01

    Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a new approach to the treatment of older people at risk of further functional decline and institutionalisation. The strategies to be examined are readily transferable to routine clinical practice and are applicable broadly in the setting of aged care health services. Trial Registration Australian New Zealand Clinical Trails Registry: ACTRN12608000250336.

  12. Bayes' postulate for trinomial trials

    Science.gov (United States)

    Diniz, M. A.; Polpo, A.

    2012-10-01

    In this paper, we discuss Bayes' postulate and its interpretation. We extend the binomial trial method proposed by de Finetti [1] to trinomial trials, for which we argue that the consideration of equiprobability a priori for the possible outcomes of the trinomial trials implies that the parameter vector has Dirichlet(1,1) as prior. Based on this result, we agree with Stigler [2] in that the notion in Bayes' postulate stating "absolutely know nothing" is related to the possible outcomes of an experiment and not to "non-information" about the parameter.

  13. Sequential boundaries approach in clinical trials with unequal allocation ratios

    Directory of Open Access Journals (Sweden)

    Ayatollahi Seyyed

    2006-01-01

    Full Text Available Abstract Background In clinical trials, both unequal randomization design and sequential analyses have ethical and economic advantages. In the single-stage-design (SSD, however, if the sample size is not adjusted based on unequal randomization, the power of the trial will decrease, whereas with sequential analysis the power will always remain constant. Our aim was to compare sequential boundaries approach with the SSD when the allocation ratio (R was not equal. Methods We evaluated the influence of R, the ratio of the patients in experimental group to the standard group, on the statistical properties of two-sided tests, including the two-sided single triangular test (TT, double triangular test (DTT and SSD by multiple simulations. The average sample size numbers (ASNs and power (1-β were evaluated for all tests. Results Our simulation study showed that choosing R = 2 instead of R = 1 increases the sample size of SSD by 12% and the ASN of the TT and DTT by the same proportion. Moreover, when R = 2, compared to the adjusted SSD, using the TT or DTT allows to retrieve the well known reductions of ASN observed when R = 1, compared to SSD. In addition, when R = 2, compared to SSD, using the TT and DTT allows to obtain smaller reductions of ASN than when R = 1, but maintains the power of the test to its planned value. Conclusion This study indicates that when the allocation ratio is not equal among the treatment groups, sequential analysis could indeed serve as a compromise between ethicists, economists and statisticians.

  14. Let's face it, from trial to trial: comparing procedures for N170 single-trial estimation.

    Science.gov (United States)

    De Vos, Maarten; Thorne, Jeremy D; Yovel, Galit; Debener, Stefan

    2012-11-15

    The estimation of event-related single trial EEG activity is notoriously difficult but is of growing interest in various areas of cognitive neuroscience, such as multimodal neuroimaging and EEG-based brain computer interfaces. However, an objective evaluation of different approaches is lacking. The present study therefore compared four frequently-used single-trial data filtering procedures: raw sensor amplitudes, regression-based estimation, bandpass filtering, and independent component analysis (ICA). High-density EEG data were recorded from 20 healthy participants in a face recognition task and were analyzed with a focus on the face-selective N170 single-trial event-related potential. Linear discriminant analysis revealed significantly better single-trial estimation for ICA compared to raw sensor amplitudes, whereas the other two approaches did not improve classification accuracy. Further analyses suggested that ICA enabled extraction of a face-sensitive independent component in each participant, which led to the superior performance in single trial estimation. Additionally, we show that the face-sensitive component does not directly represent activity from a neuronal population exclusively involved in face-processing, but rather the activity of a network involved in general visual processing. We conclude that ICA effectively facilitates the separation of physiological trial-by-trial fluctuations from measurement noise, in particular when the process of interest is reliably reflected in components representing the neural signature of interest. PMID:22877577

  15. Glossary of Clinical Trials Terms

    Science.gov (United States)

    ... These data include demographics, such as age and gender, and study-specific measures (for example, systolic blood pressure, prior ... data element on ClinicalTrials.gov.) CLINICAL STUDY A research study using human subjects to evaluate biomedical or health- ...

  16. National Lung Screening Trial (NLST)

    Science.gov (United States)

    The National Lung Screening Trial (NLST), a research study sponsored by the National Cancer Institute that used low-dose helical CT scans or chest X-ray to screen men and women at risk for lung cancer.

  17. The ALCHEMIST Lung Cancer Trial

    Science.gov (United States)

    A collection of material about the ALCHEMIST lung cancer trial that will examine tumor tissue from patients with early-stage, completely resected lung cancer for gene mutations in the EGFR and ALK genes, and a

  18. Global warming on trial

    International Nuclear Information System (INIS)

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

  19. Adaptive designs in clinical trials

    OpenAIRE

    Suresh Bowalekar

    2011-01-01

    In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, th...

  20. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998. Quality was assessed by means of a validated 5-point scale and separate quality components associated with empirical evidence of bias. Only 26% of all RCTs reported sample size calculations, 52% adequa...

  1. Acupuncture trials and informed consent

    OpenAIRE

    Miller, F G; Kaptchuk, T. J.

    2007-01-01

    Participants are often not informed by investigators who conduct randomised, placebo?controlled acupuncture trials that they may receive a sham acupuncture intervention. Instead, they are told that one or more forms of acupuncture are being compared in the study. This deceptive disclosure practice lacks a compelling methodological rationale and violates the ethical requirement to obtain informed consent. Participants in placebo?controlled acupuncture trials should be provided an accurate disc...

  2. 32 CFR 935.111 - New trial.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false New trial. 935.111 Section 935.111 National... WAKE ISLAND CODE Appeals and New Trials § 935.111 New trial. A Judge of the Wake Island Court may order a new trial as required in the interest of justice, or vacate any judgment and enter a new one,...

  3. 5 CFR 316.304 - Trial period.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Trial period. 316.304 Section 316.304... Term Employment § 316.304 Trial period. (a) The first year of service of a term employee is a trial... completion of the required trial period in the same manner as prescribed by § 315.802 of this chapter....

  4. 32 CFR 935.105 - Trial.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Trial. 935.105 Section 935.105 National Defense... CODE Criminal Actions § 935.105 Trial. (a) If the accused pleads not guilty, he is entitled to a trial... Court considers practicable and necessary to the ends of justice. There is no trial by jury. (b)...

  5. HIV/AIDS Clinical Trials Fact Sheet

    Science.gov (United States)

    HIV Prevention HIV/AIDS Clinical Trials (Last updated 9/15/2015; last reviewed 9/15/2015) Key Points HIV/AIDS clinical trials are ... and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help researchers ...

  6. Einstein's Jury: Trial by Telescope

    Science.gov (United States)

    Crelinsten, Jeffrey

    2007-03-01

    While Einstein's theory of relativity ultimately laid the foundation for modern studies of the universe, it took a long time to be accepted. Between 1905 and 1930, relativity was poorly understood and Einstein worked hard to try to make it more accessible to scientists and scientifically literate laypeople. Its acceptance was largely due to the astronomy community, which undertook precise measurements to test Einstein's astronomical predictions. The well-known 1919 British eclipse expeditions that made Einstein famous did not convince most scientists to accept relativity. The 1920s saw numerous attempts to measure light-bending, as well as solar line displacements and even ether-drift. How astronomers approached the ``Einstein problem'' in these early years before and after the First World War, and how the public reacted to what they reported, helped to shape attitudes we hold today about Einstein and his ideas.

  7. Prediction of exploratory decision-making from single-trial topographic EEG analyses

    Directory of Open Access Journals (Sweden)

    Athina Tzovara

    2011-11-01

    Full Text Available Decision-making in an uncertain environment is driven by two major needs: exploring the environment to gather information or exploiting acquired knowledge to maximize reward. The processes underlying exploratory decision-making have been mainly studied by means of functional magnetic resonance imaging leaving their temporal aspects under-explored. Here, using a well-known gambling paradigm in reinforcement learning we aim at detecting when in time, at the single-trial level, the brain generators responsible for these decisions have been sufficiently activated to lead to the following decision. Our analyses, following a classification scheme, are based on extracting time-unlocked voltage topographies during reward presentation and using them to predict decisions made on the next trial. Classification accuracy, measured as the area under the Receiver Operator’s Characteristic curve was on average across 7 subjects 0.65±0.02. The crucial time period, over which enough evidence was accumulated to accurately make this prediction, started from the display of the previous reward and lasted on average across trials and subjects up to 570±18 ms post-stimulus. On an individual subject basis, distributed source estimations were performed on the extracted topographies to statistically evaluate the neural correlates of decision making. For trials leading to exploration, there was significantly higher activity in dorsolateral prefrontal cortex and in the right parietal supramarginal gyrus; areas responsible for task-switching and modulating behavior under risk and deduction. No area was more active during exploitation. We show for the first time the temporal evolution of differential patterns of brain activation in an exploratory decision-making task on a single-trial basis.

  8. Globalization of Alzheimer's disease clinical trials

    OpenAIRE

    Cummings, Jeffrey; Reynders, Robert; Zhong, Kate

    2011-01-01

    Alzheimer's disease (AD) therapies are increasingly being tested in global clinical trials. A search of ClincalTrials.gov revealed that of 269 currently active trials, 28% are currently being conducted in the United States; the majority of trials and the majority of trial sites are ex-US. The US has the largest number of trial sites of any single country; cumulatively, nearly half of all sites are outside the US. The US conducts more trials in all phases of drug development but has a greater ...

  9. Endpoints in cancer clinical trials.

    Science.gov (United States)

    Fiteni, F; Westeel, V; Pivot, X; Borg, C; Vernerey, D; Bonnetain, F

    2014-02-01

    Endpoints are measurable clinical and biological findings that are used for the development and assessment of treatment options. In the treatment of cancer, endpoints can be classified into two categories: "patient-centered clinical endpoints" including overall survival (OS) and health-related quality of life (QoL), and "tumor-centered clinical endpoints" such as progression-free survival. Surrogate endpoints are tumor-centered clinical endpoints that can be used as substitutes for patient-centered clinical endpoints, particularly OS. The choice of endpoints in oncology trials is a major problem. The published Consolidated Standards of Reporting Trials (CONSORT) best-practice guidelines encourage the reporting of clearly defined primary and secondary outcome measures. OS is the gold standard of endpoints but as increasing numbers of effective salvage treatments become available for many types of cancer, much larger numbers of patients are included; this requires a longer follow-up period and increases the cost of clinical trials. Thus, tumor-centered clinical endpoints that can be assessed earlier and used as surrogates for overall survival are increasingly studied, but most of them currently lack standardized definitions to enable cross comparison of results among different clinical trials and they have not been validated as surrogate endpoints. In addition, the variability of their definition can strongly impact the trial's conclusions by affecting both statistical power and estimation. In this context, QoL constitutes an available and useful surrogate endpoint for trials to ensure treatment benefit from both the patient and public health points of view. Methodological research should be pursued to develop standard outcome definitions for use in cancer clinical trials and to define a standardized longitudinal analysis of QoL data. PMID:24440056

  10. Interventional trials in atypical parkinsonism.

    Science.gov (United States)

    Eschlböck, S; Krismer, F; Wenning, G K

    2016-01-01

    Atypical parkinson disorders (APD) are rapidly progressive neurodegenerative diseases with a variable clinical presentation that may even mimic Parkinson's disease. Multiple system atrophy (MSA), progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are commonly summarized under this umbrella term. Significant developments in research have expanded knowledge and have broadened available symptomatic treatments, particularly for the treatment of neurogenic orthostatic hypotension. Nonetheless, symptomatic support still remains limited in all of these disorders. Currently, there exists no effective treatment to delay disease progression and disease-modifying trials have failed to provide coherent and convincing results. Recent trials of rasagiline (in MSA), rifampicin (in MSA), tideglusib (in PSP) and davunetide (in PSP) reported negative results. Nevertheless, large cohorts of patients were recruited for interventional studies in the last few years which improved our understanding of trial methodology in APDs immensely. In addition, remarkable progress in basic research has been reported recently and will provide a solid foundation for future therapeutic trials. In this review, we will summarize published randomized, placebo-controlled clinical trials (RCTs) in APDs. Additionally, the design of ongoing and unpublished interventions will be presented. PMID:26421389

  11. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

    Møller, Christian H; Jensen, Birte Østergaard; Gluud, Christian; Perko, Mario J; Lund, Jens T; Andersen, Lars Willy; Madsen, Jan Kyst; Hughes, Pia; Steinbrüchel, Daniel A

    2007-01-01

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

  12. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

    Møller, Christian H; Jensen, Birte Østergaard; Gluud, Christian; Perko, Mario J; Lund, Jens T; Andersen, Lars Willy; Madsen, Jan Kyst; Hughes, Pia; Steinbrüchel, Daniel A

    2007-01-01

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

  13. Trials for malpractice on radiodiagnostics

    International Nuclear Information System (INIS)

    Two medical malpractice lawsuits involving radiologists are presented. On the base of these claims and the radiological malpractice trials reported in the literature, evaluated by means of a data bank, we have studied the cause of the litigations presented by the patients after the radiological examinations, the verdicts and the settlement established. 16 refs

  14. Clinical Trials Shed Light on Minority Health

    Science.gov (United States)

    ... Products For Consumers Home For Consumers Consumer Updates Clinical Trials Shed Light on Minority Health Share Tweet ... health disparities The importance of including minorities in clinical trials Research collaborations OMH Director Jonca Bull's perspective ...

  15. Clinical Trials: Key to Medical Progress

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: Key to Medical Progress Past Issues / Summer ... this page please turn Javascript on. Photo iStock Clinical trials are research studies that test how well ...

  16. Artificial Pancreas Works Well in Home Trial

    Science.gov (United States)

    ... nlm.nih.gov/medlineplus/news/fullstory_154683.html Artificial Pancreas Works Well in Home Trial Study found ... 2015 (HealthDay News) -- The latest trial of an artificial pancreas system offers good news for people with ...

  17. NIH Clinical Research Trials and You

    Science.gov (United States)

    ... the News “Why should I participate in a clinical trial?” It’s your involvement that helps researchers to ... Learn more about participating » The Basics Finding a Clinical Trial Personal Stories For Parents and Children Highlights ...

  18. Microbicide clinical trial adherence: insights for introduction

    OpenAIRE

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

    2013-01-01

    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...

  19. Why are clinical trials necessary in India?

    OpenAIRE

    Poongothai, Subramani; Unnikrishnan, Ranjit; Balasubramanian, Jeyakumar; Nair, Mohan Damodaran; Mohan, Viswanathan

    2014-01-01

    Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. In addition to advancing science, clinical trials offer myriad benefits to the participants. The recent hue that created in India about clinical trials is probably an exaggeration of facts. However, these points to the need for ensur...

  20. Optimising the analysis of stroke trials

    OpenAIRE

    Gray, Laura Jayne

    2008-01-01

    Most large acute stroke trials have shown no treatment effect. Functional outcome is routinely used as the primary outcome in stroke trials. This is usually analysed using a binary analysis, e.g. death or dependency versus independence. This project assessed which statistical approaches are most efficient in analysing functional outcome data from stroke trials. Fifty five data sets from 47 (54,173 patients) completed randomised trials were assessed. Re-analysing this data with a variety ...

  1. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

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

  2. Clinical Trials Information for Patients and Caregivers

    Science.gov (United States)

    Perhaps you are thinking about participating in a clinical trial. Or maybe you have a friend or family member with cancer and are wondering if a clinical trial is right for them. This section contains basic information about clinical trials, things to think about when deciding to take part and questions to ask your doctor.

  3. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram; Zannad, Faiez; Pfeffer, Marc A

    2010-01-01

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

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

    Science.gov (United States)

    Unsworth, Nash; McMillan, Brittany D.

    2014-01-01

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

  5. Field trial of a pulsed limestone diversion well

    Science.gov (United States)

    Sibrell, Philip L.; Denholm, C.; Dunn, Margaret

    2013-01-01

    The use of limestone diversion wells to treat acid mine drainage (AMD) is well-known, but in many cases, acid neutralization is not as complete as would be desired. Reasons for this include channeling of the water through the limestone bed, and the slow reaction rate of the limestone gravel. A new approach to improve the performance of the diversion well was tested in the field at the Jennings Environmental Education Center, near Slippery Rock, PA. In this approach, a finer size distribution of limestone was used so as to allow fluidization of the limestone bed, thus eliminating channeling and increasing particle surface area for faster reaction rates. Also, water flow was regulated through the use of a dosing siphon, so that consistent fluidization of the limestone sand could be achieved. Testing began late in the summer of 2010, and continued through November of 2011. Initial system performance during the 2010 field season was good, with the production of net alkaline water, but hydraulic problems involving air release and limestone sand retention were observed. In the summer of 2011, a finer size of limestone sand was procured for use in the system. This material fluidized more readily, but acid neutralization tapered off after several days. Subsequent observations indicated that the hydraulics of the system was compromised by the formation of iron oxides in the pipe leading to the limestone bed, which affected water distribution and flow through the bed. Although results from the field trial were mixed, it is believed that without the formation of iron oxides and plugging of the pipe, better acid neutralization and treatment would have occurred. Further tests are being considered using a different hydraulic configuration for the limestone sand fluidized bed.

  6. GPON FTTH trial: lessons learned

    Science.gov (United States)

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

    2009-11-01

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

  7. What Are Clinical Trials? | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... of this page please turn Javascript on. Feature: Clinical Trials What Are Clinical Trials? Past Issues / Fall 2010 Table of Contents ... conducted all the time. The Different Phases of Clinical Trials Clinical trials related to drugs are classified ...

  8. VTT Field Trial Finnish Experiences

    International Nuclear Information System (INIS)

    Finland is actively taking part in the actions related to the implementation of the Additional Protocol. AP creates lots of challenges, not only to the IAEA but also to the EURATOM and especially to the states. In the European Union, to implement AP there are three basic boundary conditions: use of Side Letters for to transfer the duties from the States to the European Commission, statements for the Council minutes concerning the internal communication in the EU and the Additional Protocol itself. Finnish Government has made the decision not to use any Side Letters. So, Finland is going to fulfill all the obligations itself except the common duties with the European Commission. For the common duties the practical and fluent communication channels between Finland and EURATOM has to be described. STUK, Radiation and Nuclear Safety Authority, has been chosen to be a 'site representative' for all sites in Finland. There are certain challenges, which must be solved before AP comes into force in the EU. To prepare to these challenges IAEA, EURATOM and Finland started the VTT Field Trial in Otaniemi, Espoo, during the summer 2000. VTT was chosen to be a site for the Field Trial, because it's divided to the several locations all over the Finland, i e. it's complexity in defining the site boundaries, and because it is the main location where possible nuclear R and D is conducted. Thus the objectives of the VTT Field Trial were: a) to define the site, b) to determine the roles between IAEA, EU and the state, and to create information flow procedure between these organisations and c) to 97 perform a complementary access procedure. Also the R and D declaration was prepared. Finnish experiences of the VTT Field Trial is described in this paper. The most challenging part was to create practical information flow procedure between all the parties dealing with the AP, not only the new and the technical nature of the AP

  9. The DAHANCA 6 randomized trial

    DEFF Research Database (Denmark)

    Lyhne, Nina M; Primdahl, Hanne; Kristensen, Claus A; Andersen, Elo; Johansen, Jørgen; Andersen, Lisbeth J; Evensen, Jan; Mortensen, Hanna R; Overgaard, Jens

    2015-01-01

    PURPOSE: The DAHANCA 6 trial evaluated tumor response and morbidity after moderate accelerated radiotherapy compared to conventional fractionated radiotherapy in patients treated for glottic squamous cell carcinoma (SCC). Further, the failure pattern and incidence of new primary tumors were explored. PATIENTS AND METHODS: Six hundred and ninety-four patients with non-metastatic glottic SCC were randomized between six or five weekly fractions (fx/w) of radiotherapy to the same total dose. The med...

  10. A Public Trial De Novo

    DEFF Research Database (Denmark)

    Vedel, Jane Bjørn; Gad, Christopher

    2011-01-01

    This article addresses the concept of “industrial interests” and examines its role in a topical controversy about a large research grant from a private foundation, the Novo Nordisk Foundation, to the University of Copenhagen. The authors suggest that the debate took the form of a “public trial” where the grant and close(r) intermingling between industry and public research was prosecuted and defended. First, the authors address how the grant was framed in the media. Second, they redescribe the c...

  11. Conducting a successful clinical trial

    OpenAIRE

    Hagino, Carol C.

    1991-01-01

    While the Randomized Clinical Trial (RCT) is one of many research designs, it is the most powerful design available to researchers for investigating the efficacy (i.e. producing the desired effect under very controlled, ideal conditions) and effectiveness (i.e. producing the desired effect under normal, practical conditions) of an intervention. Because the RCT is the design of choice whenever possible, but is also one of the most difficult designs to execute successfully, the following articl...

  12. How transparent are migraine clinical trials?: Repository of Registered Migraine Trials (RReMiT)

    OpenAIRE

    Dufka, Faustine L.; Dworkin, Robert H.; Rowbotham, Michael C.

    2014-01-01

    Transparency in research requires public access to unbiased information prior to trial initiation and openly available results upon study completion. The Repository of Registered Migraine Trials is a global snapshot of registered migraine clinical trials and scorecard of results availability via the peer-reviewed literature, registry databases, and gray literature. The 295 unique clinical trials identified employed 447 investigational agents, with 30% of 154 acute migraine trials and 11% of 1...

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

    OpenAIRE

    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 surrogac...

  14. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram; Zannad, Faiez; Pfeffer, Marc A

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...... particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists is...

  15. Bayesian Adaptive Methods for Clinical Trials

    CERN Document Server

    Berry, Scott M

    2010-01-01

    Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, "Bayesian Adaptive Methods for Clinical Trials" explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. The book first summarizes the current state of clinical trial design and analysis and introduces the m

  16. Market Trials of Irradiated Spices

    International Nuclear Information System (INIS)

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

  17. Interpreting and using clinical trials.

    Science.gov (United States)

    Doig, G S

    1998-07-01

    In 1754, aboard HMS Salisbury, James Lind conducted a simple, controlled clinical trial. He took 12 patients with "pale and bloated skin, listlessness, an aversion to exercise, swollen gums, halitosis, ecchymotic mucous membranes, and limb edema" and allocated them to receive treatment with one of six different therapies. Since the patients receiving two of his six chosen interventions had such a dramatic recovery, he felt ethically obligated to end his trial and administer these treatments to all the remaining sailors. Today we fully recognize the impact that the controlled clinical trial can have on the development of new interventions. Unfortunately, very few of these interventions are likely to have as dramatic an impact on outcomes as lemons and oranges did on scurvy. Because the interventions we study tend to have relatively small treatment effects, and because the design and reporting of published RCTs has consistently been documented to be less than perfect, there is a real need for us to develop critical appraisal skills. This article is by no means the only approach to critical appraisal, but hopefully it serves as an adequate starting point for the journey. PMID:9700445

  18. Clinical trials and gender medicine

    Directory of Open Access Journals (Sweden)

    Mariarita Cassese

    2011-01-01

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

  19. Credentialing for participation in clinical trials

    Directory of Open Access Journals (Sweden)

    ThomasFitzgerald

    2012-12-01

    Full Text Available 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.

  20. Design of surgical randomized controlled trials involving multiple interventions

    DEFF Research Database (Denmark)

    Gurusamy, Kurinchi S; Gluud, Christian; Nikolova, Dimitrinka; Davidson, Brian R

    2011-01-01

    Surgical trials evaluating multiple interventions can be carried out by using parallel or factorial trial design. The optimal trial method has not been established.......Surgical trials evaluating multiple interventions can be carried out by using parallel or factorial trial design. The optimal trial method has not been established....

  1. Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: A case study

    Directory of Open Access Journals (Sweden)

    Daly Fergus

    2007-03-01

    Full Text Available Abstract Background It is notoriously difficult to recruit patients to randomised controlled trials in primary care. This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window. Bell's palsy, an acute unilateral paralysis of the facial nerve is just such a relatively rare condition. In this case study we describe the organisational issues presented in setting up a large randomised controlled trial of the management of Bell's palsy across primary and secondary care in Scotland and how we managed to successfully recruit and retain patients presenting in the community. Methods Where possible we used existing evidence on recruitment strategies to maximise recruitment and retention. We consider that the key issues in the success of this study were; the fact that the research was seen as clinically important by the clinicians who had initial responsibility for recruitment; employing an experienced trial co-ordinator and dedicated researchers willing to recruit participants seven days per week and to visit them at home at a time convenient to them, hence reducing missed patients and ensuring they were retained in the study; national visibility and repeated publicity at a local level delivered by locally based principal investigators well known to their primary care community; encouraging recruitment by payment to practices and reducing the workload of the referring doctors by providing immediate access to specialist care; good collaboration between primary and secondary care and basing local investigators in the otolarnygology trial centres Results Although the recruitment rate did not meet our initial expectations, enhanced retention meant that we exceeded our planned target of recruiting 550 patients within the planned time-scale. Conclusion While difficult, recruitment to and retention within multi-centre trials from primary care can be successfully achieved through the application of the best available evidence, establishing good relationships with practices, minimising the workload of those involved in recruitment and offering enhanced care to all participants. Primary care trialists should describe their experiences of the methods used to persuade patients to participate in their trials when publishing their results.

  2. Microbicide clinical trial adherence: insights for introduction

    Directory of Open Access Journals (Sweden)

    Cynthia Woodsong

    2013-04-01

    Full Text Available 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.

  3. Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform.

    Science.gov (United States)

    Treweek, Shaun; Altman, Doug G; Bower, Peter; Campbell, Marion; Chalmers, Iain; Cotton, Seonaidh; Craig, Peter; Crosby, David; Davidson, Peter; Devane, Declan; Duley, Lelia; Dunn, Janet; Elbourne, Diana; Farrell, Barbara; Gamble, Carrol; Gillies, Katie; Hood, Kerry; Lang, Trudie; Littleford, Roberta; Loudon, Kirsty; McDonald, Alison; McPherson, Gladys; Nelson, Annmarie; Norrie, John; Ramsay, Craig; Sandercock, Peter; Shanahan, Daniel R; Summerskill, William; Sydes, Matt; Williamson, Paula; Clarke, Mike

    2015-01-01

    Randomised trials are at the heart of evidence-based healthcare, but the methods and infrastructure for conducting these sometimes complex studies are largely evidence free. Trial Forge ( www.trialforge.org ) is an initiative that aims to increase the evidence base for trial decision making and, in doing so, to improve trial efficiency.This paper summarises a one-day workshop held in Edinburgh on 10 July 2014 to discuss Trial Forge and how to advance this initiative. We first outline the problem of inefficiency in randomised trials and go on to describe Trial Forge. We present participants' views on the processes in the life of a randomised trial that should be covered by Trial Forge.General support existed at the workshop for the Trial Forge approach to increase the evidence base for making randomised trial decisions and for improving trial efficiency. Agreed upon key processes included choosing the right research question; logistical planning for delivery, training of staff, recruitment, and retention; data management and dissemination; and close down. The process of linking to existing initiatives where possible was considered crucial. Trial Forge will not be a guideline or a checklist but a 'go to' website for research on randomised trials methods, with a linked programme of applied methodology research, coupled to an effective evidence-dissemination process. Moreover, it will support an informal network of interested trialists who meet virtually (online) and occasionally in person to build capacity and knowledge in the design and conduct of efficient randomised trials.Some of the resources invested in randomised trials are wasted because of limited evidence upon which to base many aspects of design, conduct, analysis, and reporting of clinical trials. Trial Forge will help to address this lack of evidence. PMID:26044814

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

    Science.gov (United States)

    Sleight, P

    2004-02-01

    Clinical trials now increasingly impinge on society at large. First there is growing emphasis from health organizations on the need for unbiased evidence about the effectiveness of promoted remedies. Second, as most novel treatments accrue increased costs to society, these need to be evaluated in terms of value for money. Third, there has been confusion and concern about the resolution of conflicting evidence, especially the role of advertising and commercial pressures from a powerful pharmaceutical industry motivated by profit. Fourth, there is concern about research fraud and the ethics of clinical trials. Fifth, there is increasing suspicion of political advice, which sometimes has sought to reassure an anxious public on the basis of complex and possibly inadequate scientific information. Some of these issues are addressed by truly independent and properly constituted data and safety monitoring committees, which are of particular importance when academic investigators or universities have a large financial conflict of interest. This is now more problematic with the current encouragement of investigator-led spin-off companies. These issues are best resolved by independent financial support (from government or other institutions) rather than relying on the commercial sponsor. PMID:14746553

  5. Gatekeepers for pragmatic clinical trials.

    Science.gov (United States)

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

    2015-10-01

    To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding the use of limited and valuable resources. PMID:26374683

  6. Guidelines for planning clinical trials.

    Science.gov (United States)

    Forbes, J F

    1977-10-01

    This paper outlines the necessary steps involved in setting up and administering a clinical trial. The importance of adequate preparation, with careful definition of priorities and objectives, is emphasized. Guidelines for writing a clinical protocol are discussed in detail, as well as aids to deal with the running of the study, statistical planning, and presentation of results. The principle of different types of study, methods of patient assessment, and an overall plan of study, have already been introduced in the preceding paper. PMID:273406

  7. The DiaS trial

    DEFF Research Database (Denmark)

    Andreasson, Kate; Krogh, Jesper; Rosenbaum, Bent; Gluud, Christian; Jobes, David A; Nordentoft, Merete

    2014-01-01

    BACKGROUND: In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personality disorder. The majority of patients (70% to 75%) with borderline personality disorder have a history of deliberate self-harm and 10% have a lifetime risk to die by suicide. The DiaS trial is comparing ...

  8. Melanoma vaccines: trials and tribulations

    Directory of Open Access Journals (Sweden)

    Dillman RO

    2013-10-01

    Full Text Available Robert O Dillman1,21Hoag Cancer Institute and Hoag Institute for Research and Education, Newport Beach, CA, USA; 2University of California Irvine, Irvine, CA, USAAbstract: Metastatic melanoma has been a target of immunotherapy for more than 4 decades. Three immunotherapeutics have received regulatory approval for treating melanoma: interferon-alpha, interleukin-2, and ipilimumab. The antitumor mechanisms of these products depend on enhancing existing immune responses, including autoimmune effects. The combination of autologous, cytotoxic T-lymphocytes plus high-dose interleukin-2 is a promising patient-specific therapy, but has limited clinical application. Other approaches include vaccines targeting melanoma-associated antigens, and patient-specific vaccines that utilize autologous tumor. Non-patient-specific vaccine approaches target melanocyte differentiation antigens (eg, tyrosinase, Melan-A, gp100, antigens identified by cytotoxic T-lymphocytes (eg, NY-Eso-1, Melan-A/Mart-1, Mage-3, and antigens originally identified by murine monoclonal antibodies (gangliosides, gp97, gp225. Self-renewing cells in tumor cell lines may represent tumor stem cells, but vaccines derived from allogeneic tumor cell lines have yielded disappointing results in randomized trials. Patient-specific vaccines can be derived from bulk autologous tumor or autologous tumor cell lines, and intratumoral injections of immunostimulatory fusion products have shown promise. While technically more complex to manufacture, patient-specific vaccines derived from autologous tumor cell lines have the potential to target tumor stem cells and overcome interpatient tumor cell heterogeneity. This article reviews sources of melanoma-associated antigens, costimulatory agents, and clinical trial results for various melanoma vaccines. Comparing Phase II trials is difficult because of the wide range of vaccine strategies and the differences in study patient populations; therefore, randomized trials are necessary to prove the efficacy of such products. Therapeutic vaccines are more likely to enhance, rather than replace, other anti-melanoma immune therapies. In particular, effective vaccines may be synergistic with products that block T-cell immune checkpoint molecules such as ipilimumab and monoclonal antibodies that interfere with programmed death ligand-receptor interactions.Keywords: melanoma, vaccines, melanoma-associated antigens, melanoma stem cells, dendritic cells, GM-CSF, checkpoint molecules

  9. Future clinical trials: Principles versus practice

    International Nuclear Information System (INIS)

    In developing a new cancer therapy for clinical applications, the usual process is to run a series of clinical trials to determine the appropriate doses of the new therapy, to determine the response to the new therapy and then to determine patient survival when treated by the new therapy. There are currently thousands of these trials being run worldwide. As a whole, it appears that selected principles of good clinical trials design such as the need for written protocols and written hypotheses to be tested have been well accepted practices. There also appears to be general confusion over the use of the principles of statistical inference in these trials. In this paper a review of the current thinking on what constitutes a good clinical trial is presented; particular emphasis is placed on those principles of statistical inference that have not been widely received in the clinical trials process

  10. Congruency sequence effects are driven by previous-trial congruency, not previous-trial response conflict.

    Directory of Open Access Journals (Sweden)

    JoshuaCarp

    2013-09-01

    Full Text Available Congruency effects in distracter interference tasks are often smaller after incongruent trials than after congruent trials. However, the sources of such congruency sequence effects (CSEs are controversial. The conflict monitoring model of cognitive control links CSEs to the detection and resolution of response conflict. In contrast, competing theories attribute CSEs to attentional or affective processes that vary with previous-trial congruency (incongruent vs. congruent. The present study sought to distinguish between conflict and non-conflict accounts of CSEs. To this end, we determined whether CSEs are driven by previous-trial reaction time (RT--a putative measure of response conflict--or by previous-trial congruency. In two experiments using a face-word Stroop task (n=49, we found that current-trial congruency effects did not vary with previous-trial RT independent of previous-trial congruency. In contrast, current-trial congruency effects were influenced by previous-trial congruency independent of previous-trial RT. These findings appear more consistent with theories that attribute CSEs to non-conflict processes that vary with previous-trial congruency than with theories that link CSEs to previous-trial response conflict.

  11. Civil society perspectives on negative biomedical HIV prevention trial results and implications for future trials.

    Science.gov (United States)

    Essack, Zaynab; Koen, Jennifer; Slack, Catherine; Lindegger, Graham; Newman, Peter A

    2012-01-01

    Community engagement is crucial to ongoing development and testing of sorely needed new biomedical HIV prevention technologies. Yet, negative trial results raise significant challenges for community engagement in HIV prevention trials, including the early termination of the Cellulose Sulfate microbicide trial and two Phase IIb HIV vaccine trials (STEP and Phambili). The present study aimed to explore the perspectives and experiences of civil society organization (CSO) representatives regarding negative HIV prevention trial results and perceived implications for future trials. We conducted in-depth interviews with 14 respondents from a broad range of South African and international CSOs, and analyzed data using thematic analysis. CSO representatives reported disappointment in response to negative trial results, but acknowledged such outcomes as inherent to clinical research. Respondents indicated that in theory negative trial results seem likely to impact on willingness to participate in future trials, but that in practice people in South Africa have continued to volunteer. Negative trial results were described as having contributed to improving ethical standards, and to a re-evaluation of the scientific agenda. Such negative results were identified as potentially impacting on funding for trials and engagement activities. Our findings indicate that trial closures may be used constructively to support opportunities for reflection and renewed vigilance in strategies for stakeholder engagement, communicating trial outcomes, and building research literacy among communities; however, these strategies require sustained resources for community engagement and capacity-building. PMID:22360605

  12. International Clinical Trial Day and clinical trials in Ethiopia and Africa.

    Science.gov (United States)

    Fekadu, Abebaw; Teferra, Solomon; Hailu, Asrat; Gebre-Mariam, Tsige; Addissie, Adamu; Deressa, Wakgari; Yimer, Getnet; Reja, Ahmed

    2014-01-01

    Low income countries like Ethiopia are underrepresented in clinical research. As a major public commitment to clinical research, Ethiopia celebrated the International Clinical Trial Day (ICTD) for the first time on 20 May 2014 under the auspices of Addis Ababa University. The motto for the day was 'Clinical Trials for Excellence in Patient Care'. The celebration offered an opportunity to inform academic staff, researchers, students and the leadership about clinical trials being conducted and to discuss the future of clinical trials in the country. Although clear challenges to the conduct of trials abound, clinical trials registered from Ethiopia in trial registration databases is increasing. Cross-country collaborations, international funding support, motivation of academic staff to conduct clinical trials and the commitment and engagement of the leadership in research are all improving. The overall impact of clinical trials is also encouraging. For example, some of the trials conducted in Ethiopia have informed treatment guidelines. However, administrative capacity, research infrastructure as well as financial support remain weak. There is a need for enhanced university-industry linkage and translation of research findings into locally relevant evidence. Ethiopia, as well as the whole of Africa, has an unparalleled opportunity to lead the way in clinical trials, given its prospect of development and the need to have locally relevant evidence for its growing population. In this commentary we reflect on the celebration of ICTD, the status and opportunities for conducting clinical trials and the way forward for facilitating clinical trials in Ethiopia and Africa. PMID:25526797

  13. A Public Trial De Novo

    DEFF Research Database (Denmark)

    Vedel, Jane Bjørn; Gad, Christopher

    2011-01-01

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

  14. RECENT CLINICAL TRIALS IN LUPUS NEPHRITIS

    OpenAIRE

    Ward, Michael M

    2014-01-01

    Recent clinical trials have provided evidence for the efficacy of low-dose intravenous cyclophosphamide and mycophenolate mofetil as induction treatment for patients with proliferative lupus nephritis in comparative trials with standard-dose intravenous cyclophosphamide. Trials of maintenance treatments have had more variable results, but suggest that mycophenolate mofetil may be similar to quarterly standard-dose intravenous cyclophosphamide and somewhat more efficacious than azathioprine. D...

  15. Registro dos ensaios clínicos / Clinical trials register

    Scientific Electronic Library Online (English)

    Carlos Alberto, Guimarães.

    2007-06-01

    Full Text Available [...] Abstract in english The International Committee of Medical Journal Editors (ICMJE) proposed trials registration in a public trials registry, as a condition for publication. This policy started after July 1, 2005, and was supported by the World Association of Medical Editors (WAME). In May 19, 2006, the WHO urged resear [...] ch institutions and companies to register all medical studies that test treatments on human beings, whether they involve patients or healthy volunteers. The WHO also started the International Clinical Trials Registry Platform (ICTRP), aimed at standardizing the way information of studies is made available to the public. The following registers contribute data directly to the Who Search Portal: Australian Clinical Trials Registry, ClinicalTrials.gov, and International Standard Randomized Controlled Trial Number Register. In May 15, 2007, the Latin American and Caribbean Center on Health Sciences Information (BIREME) published a recommendation for editors of health journals indexed in Latin American and Caribbean Literature on Health Sciences (LILACS) and Scientific Library Electronic Online (ScieLO) about registration of clinical trials. In addition to the UMIN Clinical Trial Registry and the Nederlands Trial Register, the ICMJE is now accepting registration in any of the primary registers that participate in the WHO ICTRP. The ICMJE is also adopting the WHO's definition of clinical trial. Three years ago, trials registration was the exception; now it is the rule. Registration facilitates the dissemination of information, and it helps to assure trial participants that the information that accrues as a result of their altruism will become part of the public record.

  16. How should zoster trials be conducted?

    OpenAIRE

    Wood, M. J.; Balfour, Hank; Beutner, Karl; Bruxelle, Jean; Fiddian, Paul; Johnson, Robert; Kay, Richard; Cubed, S.; Portnoy, Joseph; Rentier, Bernard; Whitley, Richard

    1995-01-01

    In 1994, an international group of interested clinicians and biostatisticians met to discuss the design of clinical trials in herpes tester. They agreed that trials in herpes tester should have prospectively agreed definitions of all outcome measures and plans for data analysis. In immunocompetent individuals, in whom pain is the major outcome measure, trials should only include patients over the age of 50 years, and for those recruited within 72 fi of rash onset, should be designed to demons...

  17. Internet trials: participant experiences and perspectives

    OpenAIRE

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

    2012-01-01

    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...

  18. Help Finding NCI-Supported Clinical Trials

    Science.gov (United States)

    This page explains how to use the clinical trials search form to find NCI-supported clinical trials and review the results of your searches. It is helpful to gather as much information as possible before a search. Information such as the specific type and stage of cancer, the type of trial that might be relevant (treatment, diagnostic, supportive care), and other details about the patient will be helpful.

  19. Power analysis of trials with multilevel data

    CERN Document Server

    Moerbeek, Mirjam

    2015-01-01

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

  20. ?????????????? Randomized Trials: Usage in Educational Research

    Directory of Open Access Journals (Sweden)

    ??? Hak-Ping Tam

    2010-12-01

    Full Text Available ????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? Randomized trials have been around for many years as a research design. However, many factors have contributed to an emphasis on their use recently in the field of educational research and this has stirred much discussion from different aspects. The purpose of this paper is to offer an extended introduction to randomized trial design for educational researchers. It begins with an introduction to the social background that contributed to the current stress on the design. Next, the components that constitute a randomized trial will be explained with particular attention to the relationship between random assignment and causation. Two formats of randomized trials, namely, randomized controlled trials and cluster randomized trials will then be described. Afterwards, examples are given to illustrate the intricacies and the kinds of considerations needed for real world applications. Next, some concerns about randomized trials are briefly summarized followed by a presentation of counterarguments against them. The text closes with a discussion of relevant issues pertaining to randomized trial and observational studies. With awareness of the features of and the issues in such designs, interested researchers will be more comprehensive in planning a randomized trial.

  1. Clinical trials with fast neutrons in Europe

    International Nuclear Information System (INIS)

    There is an increasing number of European centres with facilities for fast neutron treatment. To prepare protocols for multi-centre trials and to make treatment results intercomparable, many obstacles have to be overcome. A provision for two dose levels in the neutron treatment arm of a trial could enable the estimation of the local cure rate for an acceptable late complication rate. The considerations on which future trials are based as well as the main characteristics of trials in progress in Europe are reported. (author)

  2. Participants' uptake of clinical trial results: a randomised experiment. : Informing participants about trial results via Internet

    OpenAIRE

    Mancini, Julien; Genre, Dominique; Dalenc, Florence; Ferrero, Jean-Marc; Kerbrat, Pierre; Martin, Anne-Laure; Roché, Henri,; Maylevin, F; Tarpin, Carole; Viens, Patrice; Genève, Jean; Julian-Reynier, Claire

    2010-01-01

    BACKGROUND: Participants are showing great interest these days in obtaining the results of clinical trials. The aim of this study was to assess patients' uptake and understanding of the results of the trial in which they have participated and the impact of a letter offering patients the possibility of consulting the trial results on a specific website. METHODS: Breast cancer patients participating in a trial on the efficacy of Trastuzumab were randomly subdivided into an Internet group (who r...

  3. Preclinical trials in autosomal dominant AD: Implementation of the DIAN-TU trial

    OpenAIRE

    Mills, S.M.; Mallmann, J.; Santacruz, A.M.; Fuqua, A.; Carril, M.; Aisen, P.S.; Althage, M.C.; Belyew, S.; Benzinger, T.L.; Brooks, W.S.; Buckles, V.D.; Cairns, N.J.; Clifford, D.; Danek, A; Fagan, A.M.

    2013-01-01

    The Dominantly Inherited Alzheimer’s Network Trials Unit (DIAN-TU) was formed to direct the design and management of interventional therapeutic trials of international DIAN and autosomal dominant Alzheimer’s disease (ADAD) participants. The goal of the DIAN-TU is to implement safe trials that have the highest likelihood of success while advancing scientific understanding of these diseases and clinical effects of proposed therapies. The DIAN-TU has launched a trial design that leverages the ex...

  4. Generalizing Evidence From Randomized Clinical Trials to Target Populations: The ACTG 320 Trial

    OpenAIRE

    Cole, Stephen R.; Elizabeth A. Stuart

    2010-01-01

    Properly planned and conducted randomized clinical trials remain susceptible to a lack of external validity. The authors illustrate a model-based method to standardize observed trial results to a specified target population using a seminal human immunodeficiency virus (HIV) treatment trial, and they provide Monte Carlo simulation evidence supporting the method. The example trial enrolled 1,156 HIV-infected adult men and women in the United States in 1996, randomly assigned 577 to a highly act...

  5. Analysis of Between-Trial and Within-Trial Neural Spiking Dynamics

    OpenAIRE

    Czanner, Gabriela; Eden, Uri T.; Wirth, Sylvia; Yanike, Marianna; Wendy A. Suzuki; Brown, Emery N.

    2008-01-01

    Recording single-neuron activity from a specific brain region across multiple trials in response to the same stimulus or execution of the same behavioral task is a common neurophysiology protocol. The raster plots of the spike trains often show strong between-trial and within-trial dynamics, yet the standard analysis of these data with the peristimulus time histogram (PSTH) and ANOVA do not consider between-trial dynamics. By itself, the PSTH does not provide a framework for statistical infer...

  6. Phase I (first-in-man) prophylactic vaccine's clinical trials: Selecting a clinical trial site

    OpenAIRE

    Shantanu Mehta; Vishal Goyal; Kavita Singh

    2015-01-01

    An appropriately equipped and staffed Phase I unit is critical for smooth conduct of a first-in-man clinical trial. The first-in-man prophylactic vaccine trial(s) requires basic infrastructure of clinical trial site, experienced and dedicated site staff and healthy adults as volunteers. The facility should have access to equipment, emergency services, laboratory, pharmacy and archiving. In terms of design, infrastructure, workflow and manpower, a Phase I unit for testing a novel vaccine or dr...

  7. The L'Aquila trial

    Science.gov (United States)

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

    2013-04-01

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

  8. Alien wavelength modeling tool and field trial

    DEFF Research Database (Denmark)

    Sambo, N.; Sgambelluri, A.; Secondini, M.; Petersen, Martin Nordal; Fagertun, Anna Manolova; Roberts, G.

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

  9. National Lung Screening Trial Results: Fast Facts

    Science.gov (United States)

    On November 4, 2010, the NLST reported initial trial results, showing 20 percent fewer lung cancer deaths among trial participants screened with low-dose helical CT (also known as spiral CT) compared to those who got screened with chest X-rays.

  10. Homo Economicus and the Salem Witch Trials.

    Science.gov (United States)

    Mixon, Franklin G., Jr.

    2000-01-01

    Provides background information on the Salem Witch Trials (Salem, Massachusetts) and the medical explanation of the young village girls' behavior in Salem called ergotism (bread poisoning). Presents an economic interpretation of those trials, stating that the ministers employed religious beliefs about witchcraft to maintain their churchs' monopoly…

  11. For better or worse: Prior trial accuracy affects current trial accuracy in visual search.

    Science.gov (United States)

    Winkle, Jonathan; Biggs, Adam; Ericson, Justin; Mitroff, Stephen

    2015-01-01

    Life is not a series of independent events, but rather, each event is influenced by what just happened and what might happen next. However, many research studies treat any given trial as an independent and isolated event. Some research fields explicitly test trial-to-trial influences (e.g., repetition priming, task switching), but many, including visual search, largely ignore potential inter-trial effects. While trial-order effects could wash out with random presentation orders, this does not diminish their potential impact (e.g., would you want your radiologist to be negatively affected by his/her prior success in screening for cancer?). To examine biases related to prior trial performance, data were analyzed from airport security officers and Duke University participants who had completed a visual search task. Participants searched for a target "T" amongst "pseudo-L" distractors with 50% of trials containing a target. Four set sizes were used (8,16,24,32), and participants completed the search task without feedback. Inter-trial analyses revealed that accuracy for the current trial was related to the outcome of the previous trial, with trials following successful searches being approximately 10% more accurate than trials following failed searches. Pairs of target-absent or target-present trials predominantly drove this effect; specifically, accuracy on target-present trials was contingent on a previous hit or miss (i.e., other target-present trials), while accuracy on target-absent trials was contingent on a previous correct rejection or false alarm (i.e., other target-absent trials). Inter-trial effects arose in both population samples and were not driven by individual differences, as assessed by mixed-effects linear modeling. These results have both theoretical and practical implications. Theoretically, it is worth considering how to control for inter-trial variance in statistical models of behavior. Practically, characterizing the conditions that modulate inter-trial effects might help professionals searchers perform more accurately, which can have life-saving consequences. Meeting abstract presented at VSS 2015. PMID:26327059

  12. Paperless clinical trials: Myth or reality?

    Directory of Open Access Journals (Sweden)

    Sandeep K Gupta

    2015-01-01

    Full Text Available There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process.

  13. Paperless clinical trials: Myth or reality?

    Science.gov (United States)

    Gupta, Sandeep K.

    2015-01-01

    There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process. PMID:26288464

  14. Why are clinical trials necessary in India?

    Science.gov (United States)

    Poongothai, Subramani; Unnikrishnan, Ranjit; Balasubramanian, Jeyakumar; Nair, Mohan Damodaran; Mohan, Viswanathan

    2014-01-01

    Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. In addition to advancing science, clinical trials offer myriad benefits to the participants. The recent hue that created in India about clinical trials is probably an exaggeration of facts. However, these points to the need for ensuring proper compliance with the regulatory norms and proper training of concerned personnel in good clinical practice (GCP). This will ensure that India continues to reap the benefits of clinical trials and also become a world leader in this field. PMID:24741480

  15. Clinical trials in Russia: achieving excellence

    Science.gov (United States)

    Reznik, Robert S.; Ichim, Thomas E.; Petrov, Vladimir; Reznik, Boris N.

    2005-06-01

    The Russian population offers a unique opportunity for conducting clinical trials in general, and specifically in the area of Medical Devices. Although the regulatory framework for approval of clinical trials and eventual marketing registration is based on an American-style format, details of operating in the Russian framework are very different. Understanding and leveraging the unique characteristics of the Russian system on the patient side, the investigator side, and the regulatory side is important in extracting optimum value out of clinical trials in Russia. Having performed Medical Device research and clinical trials in Russia, the authors overview the present system and describe various strategies for working in this growing but still under-utilized clinical trials arena.

  16. Why are clinical trials necessary in India?

    Directory of Open Access Journals (Sweden)

    Subramani Poongothai

    2014-01-01

    Full Text Available Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. In addition to advancing science, clinical trials offer myriad benefits to the participants. The recent hue that created in India about clinical trials is probably an exaggeration of facts. However, these points to the need for ensuring proper compliance with the regulatory norms and proper training of concerned personnel in good clinical practice (GCP. This will ensure that India continues to reap the benefits of clinical trials and also become a world leader in this field.

  17. Ethics of clinical trials in Nigeria

    Directory of Open Access Journals (Sweden)

    Patrick I Okonta

    2014-01-01

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

  18. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria. PMID:25013247

  19. A randomized, placebo-controlled trial of oxycodone and of gabapentin for acute pain in herpes zoster.

    Science.gov (United States)

    Dworkin, Robert H; Barbano, Richard L; Tyring, Stephen K; Betts, Robert F; McDermott, Michael P; Pennella-Vaughan, Janet; Bennett, Gary J; Berber, Erhan; Gnann, John W; Irvine, Carrie; Kamp, Cornelia; Kieburtz, Karl; Max, Mitchell B; Schmader, Kenneth E

    2009-04-01

    Although acute pain in patients with herpes zoster can be severe and has a substantial impact on health-related quality of life, there have been no randomized clinical trials of oral medications specifically for its ongoing treatment. A randomized clinical trial was conducted in which 87 subjects >or=50 years of age with herpes zoster within 6 calendar days of rash onset and with worst pain in the past 24h >or=3 on a 0-10 rating scale initiated 7 days of treatment with famciclovir in combination with 28 days of treatment with either controlled-release (CR) oxycodone, gabapentin, or placebo. Subjects were evaluated for adverse effects of treatment, acute pain, and health-related quality of life. The results showed that CR-oxycodone and gabapentin were generally safe and were associated with adverse events that reflect well-known effects of these medications. Discontinuing participation in the trial, primarily associated with constipation, occurred more frequently in subjects randomized to CR-oxycodone (27.6%) compared with placebo (6.9%). Treatment with CR-oxycodone reduced the mean worst pain over days 1-8 (p=0.01) and days 1-14 (p=0.02) relative to placebo but not throughout the entire 28-day treatment period as pain resolved in most subjects. Gabapentin did not provide significantly greater pain relief than placebo, although the data for the first week were consistent with a modest benefit. By demonstrating that CR-oxycodone is safe, generally adequately tolerated, and appears to have efficacy for relieving acute pain, the results of this clinical trial provide a foundation for evidence-based treatment for acute pain in herpes zoster. PMID:19195785

  20. Clinical Trials: Information and Options for People with Mood Disorders

    Science.gov (United States)

    ... Research Find Research Studies Peer Support Research WeSearchTogether Clinical Trials: Information and Options for People with Mood Disorders What are clinical trials? Clinical trials are research studies involving people, ...

  1. Efficacy, effectiveness, and behavior change trials in exercise research

    OpenAIRE

    Courneya Kerry S

    2010-01-01

    Abstract Background The widespread incorporation of behavioral support interventions into exercise trials has sometimes caused confusion concerning the primary purpose of a trial. The purpose of the present paper is to offer some conceptual and methodological distinctions among three types of exercise trials with a view towards improving their design, conduct, reporting, and interpretation. Discussion Exercise trials can be divided into "health outcome trials" or "behavior change trials" base...

  2. Clinical trial registration in oral health journals.

    Science.gov (United States)

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

    2015-03-01

    Prospective registration of randomized controlled trials (RCTs) represents the best solution to reporting bias. The extent to which oral health journals have endorsed and complied with RCT registration is unknown. We identified journals publishing RCTs in dentistry, oral surgery, and medicine in the Journal Citation Reports. We classified journals into 3 groups: journals requiring or recommending trial registration, journals referring indirectly to registration, and journals providing no reference to registration. For the 5 journals with the highest 2012 impact factors in each group, we assessed whether RCTs with results published in 2013 had been registered. Of 78 journals examined, 32 (41%) required or recommended trial registration, 19 (24%) referred indirectly to registration, and 27 (35%) provided no reference to registration. We identified 317 RCTs with results published in the 15 selected journals in 2013. Overall, 73 (23%) were registered in a trial registry. Among those, 91% were registered retrospectively and 32% did not report trial registration in the published article. The proportion of trials registered was not significantly associated with editorial policies: 29% with results in journals that required or recommended registration, 15% in those that referred indirectly to registration, and 21% in those providing no reference to registration (P = 0.05). Less than one-quarter of RCTs with results published in a sample of oral health journals were registered with a public registry. Improvements are needed with respect to how journals inform and require their authors to register their trials. PMID:25274753

  3. Justifying clinical trials for porcine islet xenotransplantation.

    Science.gov (United States)

    Ellis, Cara E; Korbutt, Gregory S

    2015-01-01

    The development of the Edmonton Protocol encouraged a great deal of optimism that a cell-based cure for type I diabetes could be achieved. However, donor organ shortages prevent islet transplantation from being a widespread solution as the supply cannot possibly equal the demand. Porcine islet xenotransplantation has the potential to address these shortages, and recent preclinical and clinical trials show promising scientific support. Consequently, it is important to consider whether the current science meets the ethical requirements for moving toward clinical trials. Despite the potential risks and the scientific unknowns that remain to be investigated, there is optimism regarding the xenotransplantation of some types of tissue, and enough evidence has been gathered to ethically justify clinical trials for the most safe and advanced area of research, porcine islet transplantation. Researchers must make a concerted effort to maintain a positive image for xenotransplantation, as a few well-publicized failed trials could irrevocably damage public perception of xenotransplantation. Because all of society carries the burden of risk, it is important that the public be involved in the decision to proceed. As new information from preclinical and clinical trials develops, policy decisions should be frequently updated. If at any point evidence shows that islet xenotransplantation is unsafe, then clinical trials will no longer be justified and they should be halted. However, as of now, the expected benefit of an unlimited supply of islets, combined with adequate informed consent, justifies clinical trials for islet xenotransplantation. PMID:26381492

  4. Cancer screening trials: nuts and bolts.

    Science.gov (United States)

    Prorok, Philip C; Marcus, Pamela M

    2010-06-01

    The most rigorous and valid approach to evaluating cancer screening modalities is the randomized controlled trial (RCT). RCTs are major undertakings and the intricacies of trial design, operations, and management are generally underappreciated by the typical researcher. The purpose of this article is to inform the reader of the "nuts and bolts" of designing and conducting cancer screening RCTs. Following a brief introduction as to why RCTs are critical in evaluating screening modalities, we discuss design considerations, including the choice of design type and duration of follow-up. We next present an approach to sample-size calculations. We then discuss aspects of trial implementation, including recruitment, randomization, and data management. A discussion of commonly employed data analyses comes next, and includes methods for the primary analysis (comparison of cause-specific mortality rates between the screened and control arms for the cancer of interest), as well as for secondary endpoints such as sensitivity. We follow with a discussion of sequential monitoring and interim analysis techniques, which are used to examine the primary outcome while the trial is ongoing. We close with thoughts on lessons learned from past cancer screening RCTs and provide recommendations for future trials. Throughout the presentation we illustrate topics with examples from completed or ongoing RCTs, including the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial and the National Lung Screening Trial (NLST). PMID:20709206

  5. National trials involving lymphatic mapping for melanoma: the Multicenter Selective Lymphadenectomy Trial, the Sunbelt Melanoma Trial, and the Florida Melanoma Trial.

    Science.gov (United States)

    Reintgen, Douglas; Pendas, Solange; Jakub, James; Swor, Gray; Giuliano, Rosemary; Bauer, Jan; Cassall, Robert; Duhaime, Lisa; Alsarrai, Marwin; Shivers, Steve

    2004-06-01

    Radioguided surgery and lymphatic mapping provide more accurate staging and a less morbid operation for the patient with malignant melanoma. It has rapidly become the standard of care for the nodal staging of this disease. Regional and national trials have been designed to address various questions that concern the application of this technique. The Multicenter Selective Lymphadenectomy Trial (MSLT), being performed by Donald Morton at the John Wayne Cancer Institute, is a national trial that will address whether this surgical strategy provides a survival benefit for patients. The national, industry-sponsored SunBelt Melanoma Trial (SBMT), with Kelly McMasters from the University of Louiville as the principle investigator, will determine the role of molecular staging in patients who undergo sentinel lymph node (SLN) harvest. In another arm of the study, the role of adjuvant interferon alfa (IFN) will be examined in patients with minimal disease in the regional basin, those patients with just one microscopically positive SLN. Finally, the Florida Melanoma Trial (FMT), with the central office and laboratory located at the Lakeland Regional Cancer Center, is a regional, industry-sponsored trial that will determine whether all patients with a positive SLN need to undergo a complete lymph node dissection (CLND) of the affected basin. Clinicians await the results of these three trials to help to determine the final role of radioguided surgery in patients with malignant melanoma. PMID:15190494

  6. Field trials at Bikini Atoll

    International Nuclear Information System (INIS)

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

  7. IAEA monitoring field trials workshop

    International Nuclear Information System (INIS)

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

  8. Function: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Shakuri Seyed Kazem

    2015-03-01

    Full Text Available Introduction: Prevention of pulmonary complications after coronary artery bypass graft is attended as a very important issue. The aim of this study was to evaluate the role of pulmonary rehabilitation before surgery for reducing the risk of pulmonary complications after surgery. Methods: In a randomized clinical trial, 60 patients undergoing heart surgery were randomly divided into two groups A and B. Chest physiotherapy was performed before and after surgery on group A patients however it was done on group B’s, only after surgery. Effects of preoperative pulmonary rehabilitation were compared between two groups, using spirometry and arterial blood gas (ABG. Results: Thirty nine males (65% and 21 females (35% with mean age of 8.10 ± 9.56 were analyzed.The mean differences were statistically significant for predicted forced vital capacity (FVC (CI95%:1.3 to 8.7 and Predicted Peak Flow indices (PEF (CI 95%: 1.9 to 9.4 of spirometry indicator,PCO2 index (of ABG parameter (CI 95%: 1.4 to 8.9 and mean oxygen saturation (mean Spo2 (CI 95%: 0.6 to 1.7 of ABG index in two groups. Conclusion: The performance of pulmonary rehabilitation program before surgery is recommended, as it may result in the reduction of complications of heart surgery.

  9. 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.

  10. Are explanatory trials ethical? Shifting the burden of justification in clinical trial design.

    Science.gov (United States)

    Borgerson, Kirstin

    2013-08-01

    Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under "ideal" conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under "usual" conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs. PMID:23812957

  11. Trial-Based Tournament: Rank and Earnings

    OpenAIRE

    Pongou, Roland; Tchantcho, Bertrand; Tedjeugang, Narcisse

    2015-01-01

    Trial-based tournament is a widespread hiring mechanism in organizations. Upon a job opening, an applicant is tried out at the job, then swaps with another competing applicant, and so on, with each non-competing worker holding the same position across trials. The job is offered to the applicant whose trial has had the most positive effect on the organization's output. We formalize this tournament model, deriving measures of relative performance that can be used to rank workers for each job an...

  12. Provenance trials of larch in Siberia

    Energy Technology Data Exchange (ETDEWEB)

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

    1995-12-31

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

  13. A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis (DIABOLO trial

    Directory of Open Access Journals (Sweden)

    Fockens Paul

    2010-07-01

    Full Text Available Abstract Background Conservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy. It is, however, uncertain whether patients with acute diverticulitis indeed benefit from antibiotics. In most guidelines issued by professional organizations antibiotics are considered mandatory in the treatment of mild diverticulitis. This advice lacks evidence and is merely based on experts' opinion. Adverse effects of the use of antibiotics are well known, including allergic reactions, development of bacterial resistance to antibiotics and other side-effects. Methods A randomized multicenter pragmatic clinical trial comparing two treatment strategies for uncomplicated acute diverticulitis. I A conservative strategy with antibiotics: hospital admission, supportive measures and at least 48 hours of intravenous antibiotics which subsequently are switched to oral, if tolerated (for a total duration of antibiotic treatment of 10 days. II A liberal strategy without antibiotics: admission only if needed on clinical grounds, supportive measures only. Patients are eligible for inclusion if they have a diagnosis of acute uncomplicated diverticulitis as demonstrated by radiological imaging. Only patients with stages 1a and 1b according to Hinchey's classification or "mild" diverticulitis according to the Ambrosetti criteria are included. The primary endpoint is time-to-full recovery within a 6-month follow-up period. Full recovery is defined as being discharged from the hospital, with a return to pre-illness activities, and VAS score below 4 without the use of daily pain medication. Secondary endpoints are proportion of patients who develop complicated diverticulitis requiring surgery or non-surgical intervention, morbidity, costs, health-related quality of life, readmission rate and acute diverticulitis recurrence rate. In a non-inferiority design 264 patients are needed in each study arm to detect a difference in time-to-full recovery of 5 days or more with a power of 85% and a confidence level of 95%. With an estimated one percent of patients lost to follow up, a total of 533 patients will be included. Conclusion A clinically relevant difference of more than 5 days in time-to-full recovery between the two treatment strategies is not expected. The liberal strategy without antibiotics and without the strict requirement for hospital admission is anticipated to be more a more cost-effective approach. Trial registration Trial registration number: NCT01111253

  14. A comparison of interventional clinical trials in rare versus non-rare diseases: an analysis of ClinicalTrials.gov

    OpenAIRE

    Bell, Stuart A; Tudur Smith, Catrin

    2014-01-01

    Objectives To provide a comprehensive characterisation of rare disease clinical trials registered in ClinicalTrials.gov, and compare against characteristics of trials in non-rare diseases. Design Registry based study of ClinicalTrials.gov registration entries. Methods The ClinicalTrials.gov registry comprised 133,128 studies registered to September 27, 2012. By annotating medical subject heading descriptors to condition terms we could identify rare and non-rare disease trials. A total of 24,0...

  15. Characterisation of lung tumour under dosage for interpretation of clinical trial data

    International Nuclear Information System (INIS)

    Full text: It is well known that the periphery of lung tumours is under-dosed in radiotherapy as a result of electronic disequilibrium at the interface of lung and tumour tissue. Clinical trials often employ dose calculation algorithms which poorly approximate the dose to peripheral regions of tumour volumes. The aim of this study was to develop a set of systematic under-dosage estimates corresponding to various clinical parameters. High resolution Monte Carlo radiation transport calculations were undertaken for a systematic set of generic lung tumours irradiated with an external photon beam. Varied parameters include beam energy, field size, tumour size and distance to chest wall. Calculations were undertaken using both EGSnrc and GEAI T4. A 'Dose Reduction Factor' is defined which describes the dose to the peripheral 'shell' 01 the tumour, as relevant for multiple-field and arc therapy. For a 6 MV beam, under-dosage is typically between 2 and 5% for the different arrangements investigated, and for a 15 MV beam it is between 5 and 8% (relative to the central dose). Good agreement between EGSnrc and GEANT4 was demonstrated. Comparisons with pencil beam convolution calculations indicate that the treatment planning system does not identify this under-dosage. A systematic set of data has been obtained that characterises the extent of peripheral under-dosage in lung tumours for the retrospective evaluation of clinical trial data. The data presented i: also informative for clinics using less sophisticated planning algorithms, particularly when dose is being prescribed to covering isodoses. (author)

  16. On Some Aspects of Conditional Power Evaluation In Two-phase Clinical Trials Under Linear Regression

    Directory of Open Access Journals (Sweden)

    A. S. Hedayat

    2012-07-01

    Full Text Available Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman","serif";} We investigate the conditional power under the framework of linear regression models so that it can be applied to most actual clinical trials in which multiple treatment effects and covariate effects are included. It is well known that the standard power of a regular test for a treatment contrast depends on unknown parameters only through the contrast itself. However it is not true in general for conditional power. Conditions for this to happen are established here and some instances are illustrated. We also show that similar arguments can be made about the sufficient statistics for the conditional power.

  17. Low-cost glass ionomer cement as ART sealant in permanent molars: a randomized clinical trial

    Scientific Electronic Library Online (English)

    Daniela, HESSE; Clarissa Calil, BONIFÁCIO; Camila de Almeida Brandão, GUGLIELMI; Carolina da, FRANCA; Fausto Medeiros, MENDES; Daniela Prócida, RAGGIO.

    Full Text Available Clinical trials are normally performed with well-known brands of glass ionomer cement (GIC), but the cost of these materials is high for public healthcare in less-affluent communities. Given the need to research cheaper materials, it seems pertinent to investigate the retention rate of a low-cost GI [...] C applied as atraumatic restorative treatment (ART) sealants in two centers in Brazil. Four hundred and thirty-seven 6-to-8-year-old schoolchildren were selected in two cities in Brazil. The children were randomly divided into two groups, according to the tested GIC applied in the first permanent molars. The retention rate was evaluated after 3, 6 and 12 months. Kaplan-Meier survival analysis and the log-rank test were performed. The variables were tested for association with sealant longevity, using logistic regression analyses (? = 5%). The retention rate of sealants after 12 months was 19.1%. The high-cost GIC brand presented a 2-fold-more-likely-to-survive rate than the low-cost brand (p

  18. Clinical Trials and Translational Research Advisory Committee

    Science.gov (United States)

    CCCT supports the NCI Clinical Trials and Translational Research Advisory Committee (CTAC), an external oversight committee that advises NCI leadership on ways to enhance NCI's clinical and translational research enterprises.

  19. Problems for clinical trial with fast neutrons

    International Nuclear Information System (INIS)

    It has been confirmed through a clinical trial that the local control rate for radioresistant tumors or locally advanced tumors would be improved by applying such a high LET radiations. The treatment policy for various diseases candidated to this trial has reached an agreement among the oncologists. On the other hand, there were some problems to promote fast neutron therapy. These were as follows. (a) Evaluation of late effects of the normal tissues in the relation with local control of the tumors. (b) Promotion of a randomized clinical trial for accurate evaluation of the results. (c) Development of a system for high LET radiation therapy, including distribution of the machines. From this trial, improvement of the dose distribution for fast neutrons was urgently recommended in order to apply the special features of high LET radiations in radiotherapy. (author)

  20. Nutrition Intervention Trials in Linxian, China

    Science.gov (United States)

    Randomized controlled trials were launched in 1985 to test the effects of multiple vitamin and mineral interventions on total mortality and total and cause-specific cancer mortality in a rural Chinese population

  1. Citicoline for ischemic stroke: ICTUS trial

    Directory of Open Access Journals (Sweden)

    Vladimir Anatolyevich Parfenov

    2012-12-01

    Full Text Available The paper gives data available in the literature on the use of citicoline in an experimental model of ischemic stroke (IS and in randomized multicenter placebo-controlled trials. It analyzes the results of the ICTUS trial in which 2298 patients with IS who received randomly citicoline or placebo for 24 hours after the onset of symptoms (I000 mg intravenously every I2 hours during the first 3 days, then orally as one 500-mg tablet every 12 hours during 6 weeks. The results of the trial confirmed the safety of citicoline used in IS, but failed to show its significant advantage over placebo in reducing the degree of disability (global improvement 90 days later. However, to pool the results of the ICTUS trial with those of other randomized multicenter placebo-controlled studies demonstrates a significant decrease in the degree of disability in IS patients treated with citicoline.

  2. Smart Technology in Lung Disease Clinical Trials.

    Science.gov (United States)

    Geller, Nancy L; Kim, Dong-Yun; Tian, Xin

    2016-01-01

    This article describes the use of smart technology by investigators and patients to facilitate lung disease clinical trials and make them less costly and more efficient. By "smart technology" we include various electronic media, such as computer databases, the Internet, and mobile devices. We first describe the use of electronic health records for identifying potential subjects and then discuss electronic informed consent. We give several examples of using the Internet and mobile technology in clinical trials. Interventions have been delivered via the World Wide Web or via mobile devices, and both have been used to collect outcome data. We discuss examples of new electronic devices that recently have been introduced to collect health data. While use of smart technology in clinical trials is an exciting development, comparison with similar interventions applied in a conventional manner is still in its infancy. We discuss advantages and disadvantages of using this omnipresent, powerful tool in clinical trials, as well as directions for future research. PMID:26135330

  3. Give Therapy Tools a Pre-Trial

    Science.gov (United States)

    Davis, Georgia M.

    1969-01-01

    Stresses the need for local materials centers which loan speech and hearing materials to therapists for trial and evaluation. Borrowing privileges enhance the probability of careful selection and purchase of needed materials. (MB)

  4. Overcoming Age Limits in Cancer Clinical Trials

    Science.gov (United States)

    Adolescents, young adults, and the elderly lag far behind other age groups when it comes to enrolling in clinical trials. Their participation is critical to advancing effective therapies for these age groups.

  5. Calculating Outsourcing Strategies and Trials of Strength

    DEFF Research Database (Denmark)

    Christensen, Mark; Skærbæk, Peter; Tryggestad, Kjell

    was termed ‘internal optimization’ to first increase efficiency and be followed by anticipated sequential tenders to test the free market against internal provision. This option implied a time perspective where outsourcing, if not economically feasible, would be postponed and subsequently tested. The...... we show how the two strategic options emerged and were pitted against each other in what Latour and Callon describe as ‘trials of strength’. The contribution of the paper is in four parts: 1. highlights how accounting inscriptions take part in formulating, evaluating and advancing different...... outsourcing strategies during a series of trials of strength, 2. develops the concept of ‘trial of strength’ for accounting and organization research by showing how ‘the rules of the game’ for the trials of strength can become challenged and controversial, 3. shows that, in addition to the pervasive role of...

  6. The Hawthorne Effect: a randomised, controlled trial

    OpenAIRE

    van Haselen Robbert; Iliffe Steve; Warner James; McCarney Rob; Griffin Mark; Fisher Peter

    2007-01-01

    Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participant...

  7. Phase 1 Trials in Pancreatic Cancer

    Directory of Open Access Journals (Sweden)

    Esther Yu

    2014-07-01

    Full Text Available Despite many clinical trials over the last two decades since the approval of gemcitabine, the survival of patients with pancreatic cancer has improved by a few only months. This disappointing reality underlines an urgent need to develop more effective drugs or better combinations. A variety of phase I trials were presented at the annual meeting of ASCO 2014 focusing on locally advanced and metastatic pancreatic cancer. We summarize four abstracts (abstracts #4116, #4123, #4026, #4138.

  8. Marketing and clinical trials: a case study

    OpenAIRE

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

    2007-01-01

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

  9. Controlled trial of psychotherapy for bulimia nervosa

    OpenAIRE

    Freeman, C P L; Barry, F.; Dunkeld-Turnbull, J; Henderson, A.

    1988-01-01

    In a randomised controlled trial of different types of psychotherapy for bulimia 92 women were assigned to receive cognitive-behaviour therapy (n=32), behaviour therapy (30), or group therapy (30) for 15 weeks and a further 20 (controls) assigned to remain on a waiting list for 15 weeks. Eating behaviour and psychopathology were assessed by standard methods. At the end of the trial the controls had significantly higher scores than the treated groups on all measures of bulimic behaviour. In te...

  10. Cancer Screening Trials: Nuts and Bolts

    OpenAIRE

    Prorok, Philip C; Marcus, Pamela M

    2010-01-01

    The most rigorous and valid approach to evaluating cancer screening modalities is the randomized controlled trial, or RCT. RCTs are major undertakings and the intricacies of trial design, operations, and management are generally under appreciated by the typical researcher. The purpose of this chapter is to inform the reader of the “nuts and bolts” of designing and conducting cancer screening RCTs. Following a brief introduction as to why RCTs are critical in evaluating screening modalities, w...

  11. Quality of clinical trials: A moving target

    OpenAIRE

    Bhatt, Arun

    2011-01-01

    Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common defic...

  12. Rationale for the tinnitus retraining therapy trial

    OpenAIRE

    Craig Formby; Roberta Scherer

    2013-01-01

    The Tinnitus Retraining Therapy Trial (TRTT) is a National Institutes of Health-sponsored, multi-centered, placebo-controlled, randomized trial evaluating the efficacy of tinnitus retraining therapy (TRT) and its component parts, directive counseling and sound therapy, as treatments for subjective debilitating tinnitus in the military. The TRTT will enroll 228 individuals at an allocation ratio of 1:1:1 to: (1) directive counseling and sound therapy using conventional sound generators; (2) di...

  13. Consumers’ Trial Buying Process of Service Innovation.

    OpenAIRE

    Peltonen, Laura

    2013-01-01

    The aim of this thesis was to investigate and give a deeper understanding of consumers’ trial buying process of a service innovation in an online environment. More specifically, this thesis tries to clarify the connection between consumers’ adoption decisions, external influences and the service experience of an innovation in an online environment. A trial buying process was studied in order to increase the case company HOK-Elanto’s knowledge of how their customers make adoption decisions whe...

  14. Randomised Trial Support for Orthopaedic Surgical Procedures

    OpenAIRE

    Lim, Hyeung C.; Adie, Sam; Naylor, Justine M; Harris, Ian A.

    2014-01-01

    We investigated the proportion of orthopaedic procedures supported by evidence from randomised controlled trials comparing operative procedures to a non-operative alternative. Orthopaedic procedures conducted in 2009, 2010 and 2011 across three metropolitan teaching hospitals were identified, grouped and ranked according to frequency. Searches of the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Re...

  15. Single-Trial Inference on Visual Attention

    DEFF Research Database (Denmark)

    Dyrholm, Mads; Kyllingsbæk, Søren; Vangkilde, Signe Allerup; Habekost, Thomas; Bundesen, Claus

    2011-01-01

    In this paper we take a step towards single-trial behavioral modeling within a Theory of Visual Attention (TVA). In selective attention tasks, such as the Partial Report paradigm, the subject is asked to ignore distractors and only report stimuli that belong to the target class. Nothing about a distractor is observed directly in the subject’s overt behavior, hence behavioral modeling of such trials involves out-marginalizing the variables that represent the distractors’ influence on behavior. In...

  16. The Moral Trial: On Ethics and Economics

    OpenAIRE

    Lanteri, Alessandro

    2008-01-01

    This dissertation investigates the experimental evidence exposing how economists’ behaviour differs from that of non-economists, in that economists display more self-interested conduct. A veritable Moral Trial has stemmed from that evidence, in which it is argued that economists are selfish, thus immoral, and it is recommended that we change the teaching of economics. I therefore disassemble the Moral Trial (Section I) and examine the psychological and logical soundness of both evidence and c...

  17. International dosage differences in fluoxetine clinical trials.

    OpenAIRE

    Patten, S; Cipriani, A; Brambilla, P.; Nosè, M; Barbui, C.

    2005-01-01

    OBJECTIVE: International differences are thought to exist in dosages used by clinicians treating mood disorders. This study examined international dosage differences in antidepressant clinical trials, using a database formed and maintained as a component of a Cochrane review of comparative clinical trials of fluoxetine. METHODS: This systematic review included 132 studies. A detailed set of methodological features and results were abstracted from the original publications and entered into an ...

  18. Congruency sequence effects are driven by previous-trial congruency, not previous-trial response conflict

    OpenAIRE

    Weissman, Daniel H.; Carp, Joshua

    2013-01-01

    Congruency effects in distracter interference tasks are often smaller after incongruent trials than after congruent trials. However, the sources of such congruency sequence effects (CSEs) are controversial. The conflict monitoring model of cognitive control links CSEs to the detection and resolution of response conflict. In contrast, competing theories attribute CSEs to attentional or affective processes that vary with previous-trial congruency (incongruent vs. congruent). The present study s...

  19. Survival After Solid Cancers in Antithrombotic Trials.

    Science.gov (United States)

    Serebruany, Victor L; Tomek, Ales; Kim, Moo Hyun

    2015-09-15

    The impact of antithrombotics on cancer is currently under intense investigation because of the excess of solid cancers in trials after thienopyridines such as TRITON (prasugrel), DAPT (prasugrel and clopidogrel), PAR-1 thrombin antagonist in TRACER (vorapaxar), pyrimidines in PEGASUS (ticagrelor), and in APPRAISE-2 after apixaban. However, whether patient survival after solid cancer (SASC) in antithrombotic trials may be affected is unknown. We matched the 1-year SASC rate in antithrombotic trials reported by Food and Drug Administration with the census averages in Surveillance, Epidemiology, and End Results (SEER) Program by the US National Cancer Institute and World Health Organization (WHO) surveys. The Food and Drug Administration provided the SASC data for 3 trials with similar cancer survival of about 70% for the first year of follow-up in TRITON, APPRAISE-2, and ARISTOTEL. Adjusted cancers in TRITON with SEER (odds ratio 0.92; 95% confidence interval 0.53 to 1.59, p = 0.4351) and WHO (odds ratio 0.99; 95% confidence interval 0.57 to 1.7, p = 1.00) revealed very close if not identical SASC rates in antithrombotic trials compared to epidemiologic census estimates. In conclusion, SASC rates in patients enrolled in antithrombotic trials do not differ from SEER or World Health Organization averages. PMID:26189037

  20. Patient representatives' views on patient information in clinical cancer trials

    DEFF Research Database (Denmark)

    Dellson, Pia; Nilbert, Mef; Carlsson, Christina

    2016-01-01

    consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. METHODS: Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I...

  1. Recent trials to verify quantum mechanics

    International Nuclear Information System (INIS)

    An account of the experiments which deal with the verification of Quantum Mechanics and the hidden variable problem is made. First, the well-known EPR paradox is recalled which, in spite of its refutation by Bohr, was the starting point of the questionning on the completeness of Quantum Mechanics and of hidden variable theories; and then Bell's theorem, which shows that the two approaches, Quantum Mechanics and hidden variables, can be put in contradiction. Thereafter the various types of experiments which have been carried out on that subject, mostly concerning the correlation measurements between two photons emitted by a quantum system are described. The most recent experimental results are diverging, some of them to confirm and some others to contradict quantum mechanics. A review of these is given; and a discussion is presented about their possible implications

  2. Internet trials: participant experiences and perspectives

    Directory of Open Access Journals (Sweden)

    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; security, privacy and confidentiality issues; perceived benefits and disadvantages for researchers; technical aspects of using the Internet; and the impact of Internet data collection on information quality. Overall, more advantages were noted by participants, consistent with their preference for this mode of research over others. The majority of participants (69% would prefer to participate in Internet-based research compared to other modes of data collection in the future. Conclusion Participants in our survey would prefer to participate in Internet-based trials in the future compared to other ways of conducting trials. From the participants’ perspective, participating in Internet-based trials involves trade-offs. The central trade-off is between flexibility and convenience – a perceived benefit – and lack of connectedness and understanding – a perceived disadvantage. Strategies to maintain the convenience of the Internet while increasing opportunities for participants to feel supported, well-informed and well-understood would seem likely to increase the acceptability of Internet-based trials.

  3. To fail or not to fail : clinical trials in depression

    OpenAIRE

    Santen, Gijs Willem Eduard

    2008-01-01

    To fail or not to fail – Clinical trials in depression investigates the causes of the high failure rate of clinical trials in depression research. Apart from the difficulties in the search for new antidepressants during drug discovery, faulty clinical trial designs hinder their evaluation during drug development. This thesis focuses on three important aspects of clinical trials in depression: clinical endpoints, data analysis and trial design-related factors.

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

    Science.gov (United States)

    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

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

    Directory of Open Access Journals (Sweden)

    RufinVanRullen

    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.

  6. Biomarkers in T cell therapy clinical trials

    Directory of Open Access Journals (Sweden)

    Kalos Michael

    2011-08-01

    Full Text Available Abstract T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.

  7. Quality of clinical trials: A moving target.

    Science.gov (United States)

    Bhatt, Arun

    2011-10-01

    Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials. PMID:22145122

  8. Quality of clinical trials: A moving target

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2011-01-01

    Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

  9. Public information about clinical trials and research.

    Science.gov (United States)

    Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice

    2003-01-01

    Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research. PMID:14655315

  10. Factors influencing the participation of older people in clinical trials - data analysis from the MAVIS trial. | accrualnet.cancer.gov

    Science.gov (United States)

    Older people are less likely to be included in clinical trials. This study explores factors that influence older people’s decisions to participate in randomized clinical trials. The strongest motivator for participation was altruism. Participants valued simple trial designs, which minimize burden on participants, are well organized, and include regular and friendly communication with trial staff. The findings of this survey could be used to plan and design trials in a manner that would maximize recruitment and retention of the elderly.

  11. A trial on unruptured intracranial aneurysms (the TEAM trial): results, lessons from a failure and the necessity for clinical care trials

    OpenAIRE

    Molyneux Andrew J; Darsaut Tim E; Raymond Jean

    2011-01-01

    Abstract The trial on endovascular management of unruptured intracranial aneurysms (TEAM), a prospective randomized trial comparing coiling and conservative management, initiated in September 2006, was stopped in June 2009 because of poor recruitment (80 patients). Aspects of the trial design that may have contributed to this failure are reviewed in the hope of identifying better ways to successfully complete this special type of pragmatic trial which seeks to test two strategies that are in ...

  12. Franz Kafka's The Trial: guilty or innocent?

    Science.gov (United States)

    Siegel, E

    1996-07-01

    Through an examination of The Trial by Kafka I attempt to show that the depiction of the Court apparatus is dynamically related to the commission of unconscious crimes of the type we encounter in our patients. To provide a context for the novel, I discuss Kafka's biography and some possible unconscious motivations. My goal is to show how the concept of a particular type of superego pressure can be used to understand the subtle irony in The Trial. Although Joseph K.'s behavior frequently involves oedipal crimes, there are many preoedipal themes that help account for his experience of the Court. I contrast this psychoanalytic understanding of K.'s guilt with that of literary critics who interpret The Trial as an allegory of guilt but who minimize the psychological dimensions. PMID:8856824

  13. Developments in statistical evaluation of clinical trials

    CERN Document Server

    Oud, Johan; Ghidey, Wendimagegn

    2014-01-01

    This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

  14. Flaw detection trial using virtual ultrasonic testing

    International Nuclear Information System (INIS)

    This report presents features of ultrasonic simulation and aspects to be considered in virtual inspection trials. A simulation trial implementation and results are reported, with main purpose to test different features of the selected simulation software in creation and analysis of a virtual detectability trial. A series of simulations was conducted using simple test block geometry that included notch shaped flaws with varying depths. To make the case realistic, significant structural noise and moderate attenuation were added to the simulation using the material properties settings. The simulation was run using different probe frequency values and crystal dimensions to produce variation in the flaw detectability.The simulated ultrasonic inspection data was analyzed using analysis tools of the used software. The signal-to-noise ratios and locations of the detected indications were characterized and detectability dependence on the notch height was assessed. Also, study about signal-to-noise ratios measured from the detected indications was performed. (orig.)

  15. Problems and alternatives to classical randomized trials

    International Nuclear Information System (INIS)

    Randomized clinical trials are regarded as the most credible way of generating scientific data comparing the benefits of different therapies. However, randomized studies present difficulties in their execution. Often physicians are unwilling to participate in such studies because they do not wish to inform the patient that the treatment program will be chosen by a chance mechanism. They feel such a discussion may compromise the physician-patient relationship. In this chapter alternatives to classical randomized trials are discussed, both the advantages and the pitfalls. Also discussed are some aspects of the strategy of clinical experimentation. It is pointed out that the initiation of the definitive Phase III trials made on the basis of little prior expectation of success (''trying something out'') tends to generate false-positive results

  16. Plafibride: clinical trial of a new platelet antiaggregating agent.

    Science.gov (United States)

    Olivella, J; Vicens, B

    1981-01-01

    A clinical study with a new anti-aggregant preparation; N-2-(p-chlorophenoxy)-isobutyryl-N'-morpholinomethylurea (plafibride, ITA 104), is shown in this paper. A double blind study, was carried out comparing its effects with those of a well known antiaggregant agent, dipyridamole. No clinical nor analytical side effects of importance were observed. PMID:7032532

  17. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

    Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months. Our primary outcomes were cognitive functioning (ADAS-Cog and participant and carer-rated quality of life (QOL-AD. Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT, with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group, and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048

  18. Preventing knee injuries in adolescent female football players – design of a cluster randomized controlled trial [NCT00894595

    Directory of Open Access Journals (Sweden)

    Waldén Markus

    2009-06-01

    Full Text Available Abstract Background Knee injuries in football are common regardless of age, gender or playing level, but adolescent females seem to have the highest risk. The consequences after severe knee injury, for example anterior cruciate ligament (ACL injury, are well-known, but less is known about knee injury prevention. We have designed a cluster randomized controlled trial (RCT to evaluate the effect of a warm-up program aimed at preventing acute knee injury in adolescent female football. Methods In this cluster randomized trial 516 teams (309 clusters in eight regional football districts in Sweden with female players aged 13–17 years were randomized into an intervention group (260 teams or a control group (256 teams. The teams in the intervention group were instructed to do a structured warm-up program at two training sessions per week throughout the 2009 competitive season (April to October and those in the control group were informed to train and play as usual. Sixty-eight sports physical therapists are assigned to the clubs to assist both groups in data collection and to examine the players' acute knee injuries during the study period. Three different forms are used in the trial: (1 baseline player data form collected at the start of the trial, (2 computer-based registration form collected every month, on which one of the coaches/team leaders documents individual player exposure, and (3 injury report form on which the study therapists report acute knee injuries resulting in time loss from training or match play. The primary outcome is the incidence of ACL injury and the secondary outcomes are the incidence of any acute knee injury (except contusion and incidence of severe knee injury (defined as injury resulting in absence of more than 4 weeks. Outcome measures are assessed after the end of the 2009 season. Discussion Prevention of knee injury is beneficial for players, clubs, insurance companies, and society. If the warm-up program is proven to be effective in reducing the incidence of knee injury, it can have a major impact by reducing the future knee injury burden in female football as well as the negative long-term disabilities associated with knee injury. Trial registration NCT00894595

  19. SPIRIT 2013 Statement : Defining Standard Protocol Items for Clinical Trials

    DEFF Research Database (Denmark)

    Chan, An-Wen; Tetzlaff, Jennifer M

    2013-01-01

    The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

  20. Registration of clinical trials: Is it really needed?

    Directory of Open Access Journals (Sweden)

    Ameer Aslam

    2013-01-01

    Full Text Available Background and Aims: Withholding findings of clinical trials for publication or presentation to the regulatory authorities is a major concern. We aimed to address the importance of clinical trial registration and whether it is needed or not. Discussion: For ethical conduct of clinical trial, registration is an important but debatable issue due to proprietary interest of the pharmaceutical industry. Over the years, investigating agencies uncovered several instances of misconduct during the clinical trial. The International committee of medical journal editors requires registration of trial methodology, but does not require registration of trial results; however, the U.S. Food and Drug Administration Amendments does require researchers to register results. Conclusion: Prospective registration of clinical trial is mandatory for more transparent research and sustaining the validity of evidence based practice and availability of reliable data. Clinical trials registration has the potential to contribute substantially to improve clinical trial transparency and reducing publication bias and selective reporting.

  1. WP6 - Application Integration, Trials and Evaluation

    DEFF Research Database (Denmark)

    Prasad, Neeli R.; Cetin, Bilge Kartal; Moran, Humberto; Yousuf, Sofyan M.; Soldatos, John; Robles, Ramiro Samano; Dimitropoulos, Panos; Zarokostas, Nikos; Kolokouris, Ioannis; LECLERCQ, Jean-Philippe

    2009-01-01

    This deliverable contains all the details on the planning, description of business cases, business goals stakeholders, IT infrastructure, evaluation guidelines and other aspects of the pilot trials, that are envisioned for demonstrating the benefits of the ASPIRE middleware platform. These pilot...... trials mainly consist of controlled and carefully designed experiments that will be organized either by those partners of the consortium who have previous experience on demos or similar events for small and medium enterprises (SMEs), or by other institutions that have accepted to test the ASPIRE...

  2. Clinical Trial Design in Neuroendocrine Tumors.

    Science.gov (United States)

    Halperin, Daniel M; Yao, James C

    2016-02-01

    Neuroendocrine tumors (NETs) present tremendous opportunities for productive clinical investigation, but substantial challenges as well. Investigators must be aware of common pitfalls in study design, informed by an understanding of the history of trials in the field, to make the best use of available data and our patient volunteers. We believe the salient issues in clinical trial design and interpretation in the NET field are patient homogeneity, standardized response assessment, and rigorous design and execution. Whether designing or interpreting a study in patients with NET, these principles should drive assessment. PMID:26614378

  3. Bamboo as Soil Reinforcement: A Laboratory Trial

    OpenAIRE

    Alhaji Mohammed MUSTAPHA

    2008-01-01

    A lateritic soil classified as A-6 under AASHTO soil classification system was reinforced with 0, 1, 2 and 3 bamboo specimens at laboratory trial level to evaluate its unconfined compressive strength (UCS) and modulus of rigidity. The soil specimens were molded in cylindrical form of 38mm diameter and 76mm height while the bamboo specimens were trimmed in to circular plates of 34mm diameter and 3mm thickness. The trial soil specimens are: soil specimen without bamboo specimen (0 bamboo), soil...

  4. Future of Clinical Trials in Nepal

    Directory of Open Access Journals (Sweden)

    Brijesh Sathian

    2011-07-01

    Full Text Available Nowadays the output—and rewards—of research are based almost entirely on published papers in scientific journals. Scientists in low-income and middle-income settings would like to conduct research for their populations according to their own concerns. They want to be in the frontlines of national and global communications about their country’s experiences. I recommend that properly trained clinical trial experts from developed countries should conduct some workshops on the design, conduct and ethical issues in clinical trials to terminate the research misconduct in developing countries.

  5. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations and...... empirical analyses support the blinding of patients, health-care providers, and outcome assessors as to the trial intervention to which patients have been allocated. We encourage extensive pretrial testing of blinding procedures and explicit reporting of who was in the blinded condition and the methods used...... to ensure blinding....

  6. Photovoltaic domestic field trial. Third annual report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2005-07-01

    An update on a photovoltaics field trial that has been running for four years is presented. The PV Domestic Field Trial was set up to use the design, construction, performance and monitoring of PV units to generate data for utilities, builders and other current and potential users of PVs. Subjects covered were appearance of the systems, architectural integration, fixing methods, cost effectiveness, opinions of users, monitoring and results. During the past 12 months, most of the human effort has gone into collation of data from 22 of the 28 projects. The study was sponsored by Great Britain's DTI.

  7. Sternal and vertebral fractures, a well-known association, usually overlooked: review of six clinical cases Fracturas vertebrales y fracturas concomitantes del esternón: revisión de seis casos Fraturas vertebrais e fraturas concomitantes do esterno: revisão de seis casos

    Directory of Open Access Journals (Sweden)

    Alvaro Silva G.

    2010-09-01

    Full Text Available OBJECTIVE: the association of sternal and vertebral fractures has previously been described in the literature. These lesions are frequently overlooked at the initial evaluation. The purpose of this study was to review and discuss the diagnostic methods used to diagnose these lesions and to highlight the importance of early recognition of these fractures. METHODS: we performed a retrospective analysis of six patients who suffered sternal and concomitant vertebral fractures. Clinical charts and imaging studies were reviewed. RESULTS: all patients were diagnosed with sternal fractures at the initial evaluation, but only two were diagnosed with vertebral fractures. CONCLUSION: failure to recognize these fractures at initial evaluation may be associated with the fact that the upper thoracic region is difficult to explore. In the presence of sternal fractures, a vertebral fracture must be ruled out even though major injuries are not present. A computer tomography (CT scan and magnetic resonance imaging (MRI should be obtained despite negative X-rays if clinical suspicion is present.OBJETIVO: la asociación de las fracturas del esternón y vertebrales ha sido descrita previamente en la literatura. Estas lesiones son frecuentemente descuidadas en la evaluación inicial. El objetivo de este estudio fue analizar y discutir los métodos diagnósticos utilizados para estas lesiones y resaltar la importancia del reconocimiento precoz de estas fracturas. MÉTODOS: fue realizado un análisis retrospectivo de seis pacientes que sufrieron concomitantemente fracturas del esternón y vertebrales, por medio del análisis de las historias clínicas y exámenes de imagen. RESULTADOS: todos los pacientes fueron diagnosticados con fracturas del esternón en la evaluación inicial, pero solamente dos fueron diagnosticados con fracturas vertebrales. CONCLUSIONES: el hecho de no reconocer estas fracturas en la evaluación inicial puede estar asociado a la dificultad de explorar la región torácica superior. En la presencia de fracturas del esternón, una fractura vertebral debe ser descartada, así no estén presentes lesiones mayores. La tomografía computarizada y la resonancia magnética deben ser obtenidas en el momento de sospecha clínica, aunque el rayo-X sea negativo.OBJETIVO: a associação de fraturas do esterno e vertebral tem sido previamente descrita na literatura. Essas lesões são frequentemente negligenciadas na avaliação inicial. O objetivo deste estudo foi analisar e discutir os métodos diagnósticos utilizados para essas lesões e salientar a importância do reconhecimento precoce dessas fraturas. MÉTODOS: foi realizada uma análise retrospectiva de seis pacientes que sofreram, concomitantemente, fraturas do esterno e vertebrais, por meio da análise de prontuários e exames de imagem. RESULTADOS: todos os pacientes foram diagnosticados com fraturas do esterno na avaliação inicial, mas somente dois foram diagnosticados com fraturas vertebrais. CONCLUSÃO: o não-reconhecimento dessas fraturas na avaliação inicial pode ser associado à dificuldade de explorar a região torácica superior. Na presença de fraturas do esterno, uma fratura vertebral deve ser descartada, embora lesões maiores não sejam presentes. A tomografia computadorizada (TC e a ressonância magnética (RM devem ser obtidas se houver suspeita clínica, apesar de os raios-X serem negativos.

  8. Sternal and vertebral fractures, a well-known association, usually overlooked: review of six clinical cases / Fracturas vertebrales y fracturas concomitantes del esternón: revisión de seis casos / Fraturas vertebrais e fraturas concomitantes do esterno: revisão de seis casos

    Scientific Electronic Library Online (English)

    Alvaro, Silva G.; Paulina de, la Fuente D; Andrés, Schmidt-Hebbel N; Manuel, Valencia C.; José, Antonio Riera M; Javier del Río, A; Bernardo, Merello T; Carlos, Thibaut L..

    2010-09-01

    Full Text Available OBJETIVO: a associação de fraturas do esterno e vertebral tem sido previamente descrita na literatura. Essas lesões são frequentemente negligenciadas na avaliação inicial. O objetivo deste estudo foi analisar e discutir os métodos diagnósticos utilizados para essas lesões e salientar a importância d [...] o reconhecimento precoce dessas fraturas. MÉTODOS: foi realizada uma análise retrospectiva de seis pacientes que sofreram, concomitantemente, fraturas do esterno e vertebrais, por meio da análise de prontuários e exames de imagem. RESULTADOS: todos os pacientes foram diagnosticados com fraturas do esterno na avaliação inicial, mas somente dois foram diagnosticados com fraturas vertebrais. CONCLUSÃO: o não-reconhecimento dessas fraturas na avaliação inicial pode ser associado à dificuldade de explorar a região torácica superior. Na presença de fraturas do esterno, uma fratura vertebral deve ser descartada, embora lesões maiores não sejam presentes. A tomografia computadorizada (TC) e a ressonância magnética (RM) devem ser obtidas se houver suspeita clínica, apesar de os raios-X serem negativos. Abstract in spanish OBJETIVO: la asociación de las fracturas del esternón y vertebrales ha sido descrita previamente en la literatura. Estas lesiones son frecuentemente descuidadas en la evaluación inicial. El objetivo de este estudio fue analizar y discutir los métodos diagnósticos utilizados para estas lesiones y res [...] altar la importancia del reconocimiento precoz de estas fracturas. MÉTODOS: fue realizado un análisis retrospectivo de seis pacientes que sufrieron concomitantemente fracturas del esternón y vertebrales, por medio del análisis de las historias clínicas y exámenes de imagen. RESULTADOS: todos los pacientes fueron diagnosticados con fracturas del esternón en la evaluación inicial, pero solamente dos fueron diagnosticados con fracturas vertebrales. CONCLUSIONES: el hecho de no reconocer estas fracturas en la evaluación inicial puede estar asociado a la dificultad de explorar la región torácica superior. En la presencia de fracturas del esternón, una fractura vertebral debe ser descartada, así no estén presentes lesiones mayores. La tomografía computarizada y la resonancia magnética deben ser obtenidas en el momento de sospecha clínica, aunque el rayo-X sea negativo. Abstract in english OBJECTIVE: the association of sternal and vertebral fractures has previously been described in the literature. These lesions are frequently overlooked at the initial evaluation. The purpose of this study was to review and discuss the diagnostic methods used to diagnose these lesions and to highlight [...] the importance of early recognition of these fractures. METHODS: we performed a retrospective analysis of six patients who suffered sternal and concomitant vertebral fractures. Clinical charts and imaging studies were reviewed. RESULTS: all patients were diagnosed with sternal fractures at the initial evaluation, but only two were diagnosed with vertebral fractures. CONCLUSION: failure to recognize these fractures at initial evaluation may be associated with the fact that the upper thoracic region is difficult to explore. In the presence of sternal fractures, a vertebral fracture must be ruled out even though major injuries are not present. A computer tomography (CT) scan and magnetic resonance imaging (MRI) should be obtained despite negative X-rays if clinical suspicion is present.

  9. The Endicott Report. Trends in Employment of College and University Graduates in Business and Industry 1975. Twenty-Ninth Annual Report. A Survey of 160 Well-Known Business and Industrial Concerns.

    Science.gov (United States)

    Endicott, Frank S.

    A total of 160 companies supplied information for the 29th annual report regarding the employment of college graduates in business. Most are large or medium-size corporations that regularly recruit college men and women. A total of 31 percent of these companies plan to contact fewer colleges in 1975, but 29 percent will contact more schools. The…

  10. The RAZOR (randomized open vs robotic cystectomy) trial: study design and trial update.

    Science.gov (United States)

    Smith, Norm D; Castle, Erik P; Gonzalgo, Mark L; Svatek, Robert S; Weizer, Alon Z; Montgomery, Jeffrey S; Pruthi, Raj S; Woods, Michael E; Tollefson, Matthew K; Konety, Badrinath R; Shabsigh, Ahmad; Krupski, Tracey; Barocas, Daniel A; Dash, Atreya; Quek, Marcus L; Kibel, Adam S; Parekh, Dipen J

    2015-02-01

    The purpose of the RAZOR (randomized open vs robotic cystectomy) study is to compare open radical cystectomy (ORC) vs robot-assisted RC (RARC), pelvic lymph node dissection (PLND) and urinary diversion for oncological outcomes, complications and health-related quality of life (HRQL) measures with a primary endpoint of 2-year progression-free survival (PFS). RAZOR is a multi-institutional, randomized, non-inferior, phase III trial that will enrol at least 320 patients with T1-T4, N0-N1, M0 bladder cancer with ?160 patients in both the RARC and ORC arms at 15 participating institutions. Data will be collected prospectively at each institution for cancer outcomes, complications of surgery and HRQL measures, and then submitted to trial data management services Cancer Research and Biostatistics (CRAB) for final analyses. To date, 306 patients have been randomized and accrual to the RAZOR trial is expected to conclude in 2014. In this study, we report the RAZOR trial experimental design, objectives, data safety, and monitoring, and accrual update. The RAZOR trial is a landmark study in urological oncology, randomizing T1-T4, N0-N1, M0 patients with bladder cancer to ORC vs RARC, PLND and urinary diversion. RAZOR is a multi-institutional, non-inferiority trial evaluating cancer outcomes, surgical complications and HRQL measures of ORC vs RARC with a primary endpoint of 2-year PFS. Full data from the RAZOR trial are not expected until 2016-2017. PMID:25626182

  11. Preclinical trials in autosomal dominant AD: implementation of the DIAN-TU trial.

    Science.gov (United States)

    Mills, S M; Mallmann, J; Santacruz, A M; Fuqua, A; Carril, M; Aisen, P S; Althage, M C; Belyew, S; Benzinger, T L; Brooks, W S; Buckles, V D; Cairns, N J; Clifford, D; Danek, A; Fagan, A M; Farlow, M; Fox, N; Ghetti, B; Goate, A M; Heinrichs, D; Hornbeck, R; Jack, C; Jucker, M; Klunk, W E; Marcus, D S; Martins, R N; Masters, C M; Mayeux, R; McDade, E; Morris, J C; Oliver, A; Ringman, J M; Rossor, M N; Salloway, S; Schofield, P R; Snider, J; Snyder, P; Sperling, R A; Stewart, C; Thomas, R G; Xiong, C; Bateman, R J

    2013-10-01

    The Dominantly Inherited Alzheimer's Network Trials Unit (DIAN-TU) was formed to direct the design and management of interventional therapeutic trials of international DIAN and autosomal dominant Alzheimer's disease (ADAD) participants. The goal of the DIAN-TU is to implement safe trials that have the highest likelihood of success while advancing scientific understanding of these diseases and clinical effects of proposed therapies. The DIAN-TU has launched a trial design that leverages the existing infrastructure of the ongoing DIAN observational study, takes advantage of a variety of drug targets, incorporates the latest results of biomarker and cognitive data collected during the observational study, and implements biomarkers measuring Alzheimer's disease (AD) biological processes to improve the efficiency of trial design. The DIAN-TU trial design is unique due to the sophisticated design of multiple drugs, multiple pharmaceutical partners, academics servings as sponsor, geographic distribution of a rare population and intensive safety and biomarker assessments. The implementation of the operational aspects such as home health research delivery, safety magnetic resonance imagings (MRIs) at remote locations, monitoring clinical and cognitive measures, and regulatory management involving multiple pharmaceutical sponsors of the complex DIAN-TU trial are described. PMID:24016464

  12. The Clinical Trials Transformation Initiative (CTTI) / La Clinical Trials Transformation Initiative, CTTI

    Scientific Electronic Library Online (English)

    Alberto, Grignolo.

    Full Text Available The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership created in 2007 between the United States Food and Drug Administration (FDA) and Duke University for the purpose of identifying practices that will increase the quality and efficiency of clinical trials. The initiat [...] ive was generated from the realization that the clinical trials system in the United States has been suffering as a result of increasingly longer study start-up times, slowing enrollment of patients into trials, increasing clinical trial costs, and declining investigator interest in participating in clinical trials. Although CTTI was created to address a crisis for US clinical research, it seeks to identify practice improvements that can be applied internationally, and is therefore engaging international collaborators with international efforts that have similar objectives. CTTI's approach is to involve all sectors in the selection, conduct, and interpretation of its projects; to keep the dialogue open across sectors; to provide evidence that can influence regulatory guidance, and to attempt to create a "level playing field" when recommending change. The hope is that a broad and diverse data-driven discussion of the important issues in clinical trials will lead to meaningful change for the benefit of all concerned, and importantly for patients.

  13. Characteristics of randomised trials on diseases in the digestive system registered in ClinicalTrials.gov: a retrospective analysis

    DEFF Research Database (Denmark)

    Wildt, Signe; Krag, Aleksander; Gluud, Liselotte

    2011-01-01

    Editors (ICMJE) member journals were extracted. The subsequent publications for registered trials were identified. For published trials, data concerning publication date, primary and secondary endpoint, sample size, and whether the journal adhered to ICMJE principles were extracted. Differences between...... primary and secondary outcomes, sample size and sample size calculations data in http://ClinicalTrials.gov and in the published paper were registered. Results 105 trials were evaluated. 66 trials (63%) were published. 30% of trials were registered incorrectly after their completion date. Several data......Objectives To evaluate the adequacy of reporting of protocols for randomised trials on diseases of the digestive system registered in http://ClinicalTrials.gov and the consistency between primary outcomes, secondary outcomes and sample size specified in http://ClinicalTrials.gov and published...

  14. Who wants to join preventive trials? – Experience from the Estonian Postmenopausal Hormone Therapy Trial [ISRCTN35338757

    Directory of Open Access Journals (Sweden)

    Veerus Piret

    2005-04-01

    Full Text Available Abstract Background The interest of patients in participating in randomized clinical trials involving treatments has been widely studied, but there has been much less research on interest in preventive trials. The objective of this study was to find out how many women would be interested in a trial involving postmenopausal hormone therapy (PHT and how the women's background characteristics and opinions correlated to their interest. Methods The data come from recruitment questionnaires (n = 2000 sent to women in Estonia in 1998. A random sample of women aged 45 to 64 was drawn from the Population Registry. The trial is a two-group randomized trial comparing estrogen-progestogen therapy with placebo or no drugs. A brief description of the study was attached to the questionnaires. Women were not told at this stage of the recruitment which group they would be assigned to, however, they were told of the chance to receive either hormone, placebo or no treatment. Results After two reminders, 1312 women (66% responded. Eleven percent of the women approached (17% of the respondents were interested in joining the trial, and 8% wanted more information before deciding. When the 225 women who stated clearly that they were interested in joining and the 553 women who said they were not interested were compared, it was found that interested women were younger and, adjusting for age, that more had given birth; in other respects, the sociodemographic characteristics and health habits of the interested women were similar to those of the non-interested women. The interested women had made more use of more health services, calcium preparations and PHT, they were more often overweight, and more had chronic diseases and reported symptoms. Interested women's opinions on the menopause were more negative, and they favoured PHT more than the non-interested women. Conclusion Unlike the situation described in previous reports on preventive trials, in this case Estonian women interested in participating in a PHT trial were not healthier than other women. This suggests that trials involving PHT are more similar to treatment trials than to preventive trials. In a randomized controlled trial, more information should be obtained from those women who decline to participate.

  15. Electronic Cigarette Trial and Use among Young Adults: Reasons for Trial and Cessation of Vaping

    OpenAIRE

    Lois Biener; Eunyoung Song; Sutfin, Erin L; John Spangler; Mark Wolfson

    2015-01-01

    This paper identifies predictors of trial and current use, and reasons for trying and ceasing use of electronic cigarettes (e-cigarettes) among young adults, with particular attention to former and never smokers. Data are from a mail survey of a population-based sample of adults aged 18 to 35 (N = 4740) in three U.S. metropolitan areas. Survey items assessed trial and use of e-cigarettes, cigarette smoking status, and reasons for trial and for ceasing use of e-cigarettes. Almost 23% reported ...

  16. 7 CFR 1755.3 - Field trials.

    Science.gov (United States)

    2010-01-01

    ...trial and awareness of the effort and responsibility this entails. (e) The test site for the field...Responsibility for testing, test equipment and normal operation... (6) Availability of test equipment on site during...details of problems of failures encountered during...

  17. Understanding Clinical Trials | accrualnet.cancer.gov

    Science.gov (United States)

    Skip to content The National Cancer Institute www.cancer.gov The National Institutes of Health AccrualNetTM STRATEGIES, TOOLS AND RESOURCES TO SUPPORT ACCRUAL TO CLINICAL TRIALS User menu Register Sign In Search form Search Main menu Protocol Accrual

  18. [Single-trial estimation of dynamic spectrum].

    Science.gov (United States)

    Li, Gang; Xiong, Chan; Wang, Hui-quan; Lin, Ling; Zhang, Bao-ju; Tong, Ying

    2011-07-01

    To improve the efficiency and accuracy of the dynamic spectrum data processing, the method of single-trial estimation was adopted. First, the rising edge of the whole band PPG was extracted, which was calculated by averaging superimposed collected photoelectric plethysmography (PPG) at all wavelengths as a template per single pulse; Second, this template was used to correct the rising edge of PPG at all wavelengths, and the difference of absorbance was calculate, and then a single-trial DS was obtained; finally, the single-trial DS which contained the gross error under the 3sigma criterion was removed, and then the remaining superimposed single-trial DS was averaged as the final output of the DS. Data measured from 10 volunteers were compared with the results of the extraction in frequency domain: the correlation coefficient distribution of the DS from the same finger of the same individual was improved from 0.006775 to 0.0003840; the correlation coefficient distribution of the DS from the different fingers of the same individual was improved from 0.01393 to 0.002205, whereas the differences of DS between different indivisuals with high quality, and accelerate the process of DS put into practical application. PMID:21942039

  19. New EORTC clinical trials for BNCT

    International Nuclear Information System (INIS)

    Due to ethical reasons, a separated optimization of the two components of BNCT in the frame of clinical investigations can only be performed applying the whole binary system. The ongoing trial at HFR (High Flux Reactor Petten) has proven the feasibility of BNCT under defined conditions. On that basis the European Commission supported a comprehensive research project on boron imaging including three further clinical studies. In the first trial the boron uptake related to the blood boron concentration and surrounding normal tissue in various solid tumours will be examined using BSH (Sodiumborocaptate), BPA (Boronophenylalanine) or both in order to explore tumour entities, which may gain benefit from BNCT. The major objectives of the second trial are to define the maximum tolerated single and cumulative dose, and the dose limiting toxicity of BSH. The third clinical trial, a phase II study is designed to evaluate the anti-tumour effect of fractionated BNCT at the Petten treatment facility against cerebral metastasis of malignant melanoma using BPA. (author)

  20. Winding trials for ITER toroidal filed coils

    International Nuclear Information System (INIS)

    Cable-in-conduit (CIC) conductors using Nb3Sn strands are used in ITER toroidal fields (TF) coils. The wound TF conductor must be inserted in the groove of the radial plate (RP), which is part of the mechanical structure supporting the large electromagnetic force. Since the available gap between the conductor and RP groove is 0.5 - 3 mm, the tolerance of the circumferences of the winding and RP groove are +/- 0.023%. Since a tolerance of approximately +/-0.01% is needed for the RP machining, the conductor length of the winding must be controlled with an accuracy of +/- 0.01%. In this study, in order to resolve the above technical issues, the authors performed several trials on winding as the part of the activities in Phase II of TF coil manufacture. In these trials, the accuracy of the conductor length measurement system using the optical equipment was evaluated, and winding trials were performed on a 1/3-scale double-pancake (DP) winding to demonstrate use of the winding system. In addition, the conductor length of the 1/3-scale DP trial winding was evaluated, and the elongation of the conductor due to bending was clarified. (author)

  1. Unit: Petroleum, Inspection Pack, National Trial Print.

    Science.gov (United States)

    Australian Science Education Project, Toorak, Victoria.

    This is a National Trial Print of a unit on petroleum developed for the Australian Science Education Project. The package contains the teacher's edition of the written material and a script for a film entitled "The Extraordinary Experience of Nicholas Nodwell" emphasizing the uses of petroleum and petroleum products in daily life and designed to…

  2. Unit Microbes, First Trial Materials, Inspection Set.

    Science.gov (United States)

    Australian Science Education Project, Toorak, Victoria.

    The Australian Science Education Project is producing materials designed for use in grades 7-10 of Australian schools. This is the first trial version of a unit investigating microbial action. One of the student booklets contains instructions for the activities demonstrating food decay which all students are expected to complete. The other student…

  3. Trial access to Cambridge University Press ebooks

    CERN Multimedia

    CERN Library

    2011-01-01

    From 1 August till 31 October, CERN users are invited to enjoy a trial access to all Cambridge University Press electronic books: http://ebooks.cambridge.org/. Please don't hesitate to send feedback to library.desk@cern.ch.

  4. Trial NCT00983580 | Division of Cancer Prevention

    Science.gov (United States)

    This phase II trial is studying how well giving acetylsalicylic acid together with eflornithine works in treating patients at high risk for colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acetylsalicylic acid and eflornithine may prevent colorectal cancer.

  5. Trial NCT02123849 | Division of Cancer Prevention

    Science.gov (United States)

    This randomized phase II clinical trial studies the safety and effects of acetylsalicylic acid (aspirin) taken continuously or intermittently on gene expression in the nasal tissue of current smokers. Smokers are at increased risk of developing lung cancer. Acetylsalicylic acid may be useful in preventing lung cancer.

  6. Blast densification trials for oilsands tailings

    Energy Technology Data Exchange (ETDEWEB)

    Port, A. [Klohn Crippen Berger Ltd., Vancouver, BC (Canada); Martens, S. [Klohn Crippen Berger Ltd., Calgary, AB (Canada); Eaton, T. [Shell Canada Ltd., Calgary, AB (Canada)

    2010-07-01

    The Shell Canada Muskeg River Mine External Tailings Facility (ETF) is an upstream constructed tailings facility located near Fort McMurray, Alberta. Raises have incrementally stepped out over the beach since construction of the starter dam and deposition within standing water has left some parts of the beach in a loose state. In order to assess the effectiveness of blast densification, a blast densification trial program that was conducted in 2006 at the ETF. The primary purpose of the test program was to determine the effectiveness of blast densification in tailings containing layers and zones of bitumen. The paper described the site characterization and explosive compaction trial program, with particular reference to test layout; drilling methodology; and blasting and timing sequence. The paper also described the instrumentation, including the seismographs; high pressure electric piezometers; low pressure electric piezometers; vibrating wire piezometers; inclinometers; settlement gauges; and surveys. Trial observations and post-trial observations were also presented. It was concluded that controlled blasting techniques could be used to safely induce liquefaction in localized areas within the tailings deposit, with a resulting increase in the tailings density. 5 refs., 1 tab., 14 figs.

  7. Gone fishing in a fluid trial

    DEFF Research Database (Denmark)

    Hjortrup, Peter B; Haase, Nicolai; Wetterslev, Jørn; Perner, Anders

    2016-01-01

    , of 26 Scandinavian intensive care units between 2009 and 2011. Patients aged 18 years or older with severe sepsis and in need of fluid resuscitation, randomised in the Scandinavian Starch for Severe Sepsis/ Septic Shock (6S) trial. MAIN OUTCOME MEASURE: Ninety-day mortality. RESULTS: We included all...

  8. Stroke Prevention Trials in Sickle Cell Anemia

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2006-06-01

    Full Text Available As part of an International Pediatric Stroke Study launched in 2002, the Stroke Prevention Trial in Sickle Cell Anemia (STOP reports a reduction in the number of overt clinical strokes in children with critically high transcranial Doppler velocities (>200 cm/sec who were regularly transfused.

  9. Pipeline Decommissioning Trial AWE Berkshire UK - 13619

    Energy Technology Data Exchange (ETDEWEB)

    Agnew, Kieran [AWE, Aldermaston, Reading, RG7 4PR (United Kingdom)

    2013-07-01

    This Paper details the implementation of a 'Decommissioning Trial' to assess the feasibility of decommissioning the redundant pipeline operated by AWE located in Berkshire UK. The paper also presents the tool box of decommissioning techniques that were developed during the decommissioning trial. Constructed in the 1950's and operated until 2005, AWE used a pipeline for the authorised discharge of treated effluent. Now redundant, the pipeline is under a care and surveillance regime awaiting decommissioning. The pipeline is some 18.5 km in length and extends from AWE site to the River Thames. Along its route the pipeline passes along and under several major roads, railway lines and rivers as well as travelling through woodland, agricultural land and residential areas. Currently under care and surveillance AWE is considering a number of options for decommissioning the pipeline. One option is to remove the pipeline. In order to assist option evaluation and assess the feasibility of removing the pipeline a decommissioning trial was undertaken and sections of the pipeline were removed within the AWE site. The objectives of the decommissioning trial were to: - Demonstrate to stakeholders that the pipeline can be removed safely, securely and cleanly - Develop a 'tool box' of methods that could be deployed to remove the pipeline - Replicate the conditions and environments encountered along the route of the pipeline The onsite trial was also designed to replicate the physical prevailing conditions and constraints encountered along the remainder of its route i.e. working along a narrow corridor, working in close proximity to roads, working in proximity to above ground and underground services (e.g. Gas, Water, Electricity). By undertaking the decommissioning trial AWE have successfully demonstrated the pipeline can be decommissioned in a safe, secure and clean manor and have developed a tool box of decommissioning techniques. The tool box of includes; - Hot tapping - a method of breaching the pipe while maintaining containment to remove residual liquids, - Crimp and shear - remote crimping, cutting and handling of pipe using the excavator - Pipe jacking - a way of removing pipes avoiding excavations and causing minimal disturbance and disruption. The details of the decommissioning trial design, the techniques employed, their application and effectiveness are discussed and evaluated here in. (authors)

  10. Novel ocular antihypertensive compounds in clinical trials

    Directory of Open Access Journals (Sweden)

    Chen J

    2011-05-01

    Full Text Available June Chen1, Stephen A Runyan1, Michael R Robinson21Department of Biological Sciences, 2Ophthalmology Clinical Research, Allergan, Inc, Irvine, CA, USAIntroduction: Glaucoma is a multifactorial disease characterized by progressive optic nerve injury and visual field defects. Elevated intraocular pressure (IOP is the most widely recognized risk factor for the onset and progression of open-angle glaucoma, and IOP-lowering medications comprise the primary treatment strategy. IOP elevation in glaucoma is associated with diminished or obstructed aqueous humor outflow. Pharmacotherapy reduces IOP by suppressing aqueous inflow and/or increasing aqueous outflow.Purpose: This review focuses on novel non-FDA approved ocular antihypertensive compounds being investigated for IOP reduction in ocular hypertensive and glaucoma patients in active clinical trials within approximately the past 2 years.Methods: The mode of IOP reduction, pharmacology, efficacy, and safety of these new agents were assessed. Relevant drug efficacy and safety trials were identified from searches of various scientific literature databases and clinical trial registries. Compounds with no specified drug class, insufficient background information, reformulations, and fixed-combinations of marketed drugs were not considered.Results: The investigational agents identified comprise those that act on the same targets of established drug classes approved by the FDA (ie, prostaglandin analogs and ?-adrenergic blockers as well as agents belonging to novel drug classes with unique mechanisms of action. Novel targets and compounds evaluated in clinical trials include an actin polymerization inhibitor (ie, latrunculin, Rho-associated protein kinase inhibitors, adenosine receptor analogs, an angiotensin II type 1 receptor antagonist, cannabinoid receptor agonists, and a serotonin receptor antagonist.Conclusion: The clinical value of novel compounds for the treatment of glaucoma will depend ultimately on demonstrating favorable efficacy and benefit-to-risk ratios relative to currently approved prostaglandin analogs and ?-blockers and/or having complementary modes of action.Keywords: intraocular pressure, glaucoma progression, clinical trials, drug development, aqueous humor dynamics, antihypertensive

  11. Using e-technologies in clinical trials.

    Science.gov (United States)

    Rosa, Carmen; Campbell, Aimee N C; Miele, Gloria M; Brunner, Meg; Winstanley, Erin L

    2015-11-01

    Clinical trials have been slow to incorporate e-technology (digital and electronic technology that utilizes mobile devices or the Internet) into the design and execution of studies. In the meantime, individuals and corporations are relying more on electronic platforms and most have incorporated such technology into their daily lives. This paper provides a general overview of the use of e-technologies in clinical trials research, specifically within the last decade, marked by rapid growth of mobile and Internet-based tools. Benefits of and challenges to the use of e-technologies in data collection, recruitment and retention, delivery of interventions, and dissemination are provided, as well as a description of the current status of regulatory oversight of e-technologies in clinical trials research. As an example of ways in which e-technologies can be used for intervention delivery, a summary of e-technologies for treatment of substance use disorders is presented. Using e-technologies to design and implement clinical trials has the potential to reach a wide audience, making trials more efficient while also reducing costs; however, researchers should be cautious when adopting these tools given the many challenges in using new technologies, as well as threats to participant privacy/confidentiality. Challenges of using e-technologies can be overcome with careful planning, useful partnerships, and forethought. The role of web- and smartphone-based applications is expanding, and the increasing use of those platforms by scientists and the public alike make them tools that cannot be ignored. PMID:26176884

  12. The Radiation oncology practice standards trial

    International Nuclear Information System (INIS)

    Full text: In 2008 the Commonwealth Government approved funding of up to $1.4 million for radiation oncology practice standards (the standards) to be drafted, trialled, finalised and published. A Tripartite Standards Committee comprising representatives from the Royal Australian and New Zealand College of Radiologists (RANZCR), Australian Insti tute of Radiography (AIR) and Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM) coordinated and managed the drafting of the standards. Following public consultation in September 2008, the draft standards were endorsed for trjalling by the Radiation Oncology Reform Implementation Committee (RORIC) of the Australian Health Ministers' Advisory Council (AHMAC). In June 2009 the National Association of Testing Authorities, Australia (NATA) was engaged by the Department of Health and Ageing to conduct a trial of the draft standards by collecting feedback on their implementability with a representative sample of radiation oncology facilities. The trial formally commenced in January 20 I 0 and data is being collected via an on-line questionnaire, follow up site visits and a focus group meeting. The results will be used to establish baseline data on compliance and to assess the costs of compliance. A steering committee comprising representatives from the Tripartite Standards Committee is assisting the Commonwealth to oversight the project. The standards trial is due for completion by the end of 20 I 0, subject to facilities completing all components of the trial in the required time. The outcomes of the trial will inform a revision of the standards by the Tripartite Standards Committee for finalisation and publication. At this time consideration will be given to the tools required by facilities to assist their longer term use within the sector. This may include how compliance with the standards might be assessed. This presentation will describe the process and findings to date and describe the next steps to be taken.

  13. RTOG: Updated results of randomized trials

    International Nuclear Information System (INIS)

    Objective: To review the background, rationale and available results for recently completed randomized comparative clinical trials of the Radiation Therapy Oncology Group (RTOG), including inter group trials in which the RTOG has been the managing group or a major participant. When available, laboratory studies will be correlated with clinical results. Prospective comparative trials with concurrent control groups are necessary to ovoid bias in the acquisition and interpretation of data that contribute to the care of patients. The RTOG has conducted such trials for 28 years seeking increased survival and improved quality of life including organ preservation. The disease sites investigated (brain, head and neck, lung, gastrointestinal, genitourinary, and gynecological tracts) account for more than half of all deaths from cancer in the U. S. The major research strategies include dose intensification by means of altered fractionation and 3-dimensional conformal radiation therapy, chemical and biological modification, and integration of radiation therapy with chemotherapy and resection. Recent results document improved survival in patients with carcinomas of the cervix, esophagus, lung, and nasopharynx, organ conservation with carcinomas of the anal canal, and increased disease-free survival with carcinoma of the prostate. Data from laboratory correlation's suggest important roles for nuclear proliferation antigens, DNA content, and tumor suppressor genes. Central review of histopathological findings has proved to be of great importance for certain but not all malignant tumors studied. At present, more than 250 institutions in North America participate in clinical trials of the RTOG. This broad involvement of the radiation oncology community permits rapid transfer of benefits found by the RTOG into standard practice

  14. EDF plan for a dispersant injection trial

    International Nuclear Information System (INIS)

    In its strategy for SG fouling control, EDF is considering the use of dispersant as a preventive remedy. A trial on Golfech 2 started in May 2012. The dispersant selected for the trial is Polyacrylic Acid (PAA). The main goals of the test are to check and quantify the gain on iron transport to blowdown, to evaluate the possible effects on secondary side chemistry and the operational costs of the injection - reactant, ion exchange resins and filters. The results of the test, if satisfying, will be used to set EDF strategy for dispersant long term use on its fleet. So, one concern about the trial is to make sure that the conclusions of this test will be applicable to a wide range of EDF plants. For that purpose, several criteria have been examined for the choice of the candidate plant such as fouling level, secondary circuit materials (presence or absence of copper alloys,...), SG tube material, thermal power margin, secondary side chemistry (amine used and pH applied). Before starting the trial, EDF had to take into account the international feedback and to adapt it to its specific requirements: the neutralization amine was switched from ETA to morpholine, additional work had been completed to validate the innocuousness of PAA injection for EDF plants... This work especially includes laboratory testing of secondary side corrosion cracking in the presence of PAA and water chemistries used in EdF plants. Moreover, investigation on the thermal stability of PAA and degradation products was completed and further evaluation of environmental impact was performed. A dedicated skid for the injection of PAA was implemented in Golfech Chemicals injection room. The installation and the process were notably designed to take into account the high viscosity of the commercial product, and the need to proceed to a good rinsing of the pipes without increasing the discharged effluents. The first available data from Golfech 2 trial are also provided and discussed. (authors)

  15. Analyze the trial’s accrual data for lessons learned | accrualnet.cancer.gov

    Science.gov (United States)

    The team will likely have a general sense of how recruitment went for the trial. You may even be able to think of a few things you know now that you wish you had known at the start of the trial. Use accrual data to confirm (or not) your impressions on recruitment. If your team faced accrual difficulties, use this stage for learning and improving.

  16. Managing Injuries of the Neck Trial (MINT): a randomised controlled trial of treatments for whiplash injuries.

    OpenAIRE

    Lamb, SE; Williams, MA; Williamson, EM; Gates, S.; Withers, EJ; Mt-Isa, S; Ashby, D.; Castelnuovo, E; Underwood, M.; Cooke, MW

    2012-01-01

    OBJECTIVES: To examine the clinical effectiveness of a stepped care approach over a 12-month period after an acute whiplash injury; to estimate the costs and cost-effectiveness of each strategy including treatments and subsequent health-care costs; and to gain participants' perspective on experiencing whiplash injury, NHS treatment, and recovery within the context of the Managing Injuries of the Neck Trial (MINT). DESIGN: Two linked, pragmatic, randomised controlled trials. In Step 1, emergen...

  17. Methods for therapeutic trials in COPD: lessons from the TORCH trial

    DEFF Research Database (Denmark)

    Keene, O N; Vestbo, J; Anderson, J A; Calverley, P M A; Celli, B; Ferguson, G T; Jenkins, C; Jones, P W

    2009-01-01

    The TORCH (Towards a Revolution in COPD Health) trial has highlighted some important issues in the design and analysis of long term trials in chronic obstructive pulmonary disease. These include collection of off-treatment exacerbation data, analysis of exacerbation rates and the effect of inclusion of patients receiving inhaled corticosteroids (ICS) prior to randomisation. When effective medications are available to patients who withdraw, inclusion of off-treatment data can mask important treat...

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

    OpenAIRE

    Rapport, F; Storey, M.; Porter, A.; Snooks, H.; Jones, K; Peconi, J.; Sanchez, A.; Siebert, S; Thorn, K.; Clement, C.(Department of Physics, Stockholm University, Stockholm, Sweden; The Oskar Klein Centre, Stockholm, Sweden); Russell, I.T.

    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 influen...

  19. The National Lung Screening Trial: Overview and Study Design1

    OpenAIRE

    2011-01-01

    The National Lung Screening Trial is a multicenter, randomized controlled trial comparing low-dose helical CT with chest radiography in the screening of current and former heavy smokers for lung cancer.

  20. The therapeutic effect of clinical trials: understanding placebo response rates in clinical trials – A secondary analysis

    Directory of Open Access Journals (Sweden)

    Walach Harald

    2005-08-01

    Full Text Available Abstract Background and purpose Placebo response rates in clinical trials vary considerably and are observed frequently. For new drugs it can be difficult to prove effectiveness superior to placebo. It is unclear what contributes to improvement in the placebo groups. We wanted to clarify, what elements of clinical trials determine placebo variability. Methods We analysed a representative sample of 141 published long-term trials (randomized, double-blind, placebo-controlled; duration > 12 weeks to find out what study characteristics predict placebo response rates in various diseases. Correlational and regression analyses with study characteristics and placebo response rates were carried out. Results We found a high and significant correlation between placebo and treatment response rate across diseases (r = .78; p Conclusion Medication response rates and placebo response rates in clinical trials are highly correlated. Trial characteristics can explain some portion of the variance in placebo healing rates in RCTs. Placebo response in trials is only partially due to methodological artefacts and only partially dependent on the diagnoses treated.

  1. Cross-System Evaluation of Clinical Trial Search Engines

    OpenAIRE

    Jiang, Silis Y.; Weng, Chunhua

    2014-01-01

    Clinical trials are fundamental to the advancement of medicine but constantly face recruitment difficulties. Various clinical trial search engines have been designed to help health consumers identify trials for which they may be eligible. Unfortunately, knowledge of the usefulness and usability of their designs remains scarce. In this study, we used mixed methods, including time-motion analysis, think-aloud protocol, and survey, to evaluate five popular clinical trial search engines with 11 u...

  2. What is the impact of ethics on clinical trials?

    Science.gov (United States)

    Spielman, Bethany

    2016-01-01

    Ethics has often been ignored or evaded in clinical trials, and the conditions under which global clinical trials are conducted make this problem likely to persist. Ethics can, however, have an impact at any of several stages of a trial when the individuals involved are committed. This editorial provides historical examples of ignoring, evading or, alternatively, using ethical help to improve clinical trials, and suggests that the actual role of ethics depends on the individuals involved. PMID:26414551

  3. Sampling bias in an internet treatment trial for depression

    OpenAIRE

    Donkin, L; Hickie, I B; Christensen, H.; Naismith, S L; Neal, B; Cockayne, N L; Glozier, N

    2012-01-01

    Internet psychological interventions are efficacious and may reduce traditional access barriers. No studies have evaluated whether any sampling bias exists in these trials that may limit the translation of the results of these trials into real-world application. We identified 7999 potentially eligible trial participants from a community-based health cohort study and invited them to participate in a randomized controlled trial of an online cognitive behavioural therapy programme for people wit...

  4. Trial wave functions for High-Pressure Metallic Hydrogen

    OpenAIRE

    Pierleoni, Carlo; Delaney, Kris T.; Morales, Miguel A.; Ceperley, David M.; Holzmann, Markus

    2007-01-01

    Many body trial wave functions are the key ingredient for accurate Quantum Monte Carlo estimates of total electronic energies in many electron systems. In the Coupled Electron-Ion Monte Carlo method, the accuracy of the trial function must be conjugated with the efficiency of its evaluation. We report recent progress in trial wave functions for metallic hydrogen implemented in the Coupled Electron-Ion Monte Carlo method. We describe and characterize several types of trial functions of increas...

  5. Conducting randomized trials in general practice: methodological and practical issues.

    OpenAIRE

    Ward, E.; M. King; Lloyd, M.; Bower, P.; Friedli, K.

    1999-01-01

    The evaluation of the outcome of health services technologies is a requirement for their efficient provision in clinical practice. The most reliable evidence for treatment efficacy comes from randomized trials. Randomized trials in general practice pose particular methodological and practical difficulties. In this paper, we discuss how best to plan and manage a clinical trial in this setting. We base our discussion on our experience of conducting randomized trials to evaluate the effectivenes...

  6. 28 CFR 52.02 - Criminal proceedings: Pretrial, trial.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Criminal proceedings: Pretrial, trial. 52.... MAGISTRATE JUDGES § 52.02 Criminal proceedings: Pretrial, trial. (a) A judge of the district court, without... elect “trial, judgment, and sentencing by a judge of the district court and * * * may have a right...

  7. 40 CFR 265.225 - Waste analysis and trial tests.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 25 2010-07-01 2010-07-01 false Waste analysis and trial tests. 265... DISPOSAL FACILITIES Surface Impoundments § 265.225 Waste analysis and trial tests. (a) In addition to the... the different process: (i) Conduct waste analyses and trial treatment tests (e.g., bench scale...

  8. 32 CFR 150.22 - Petitions for new trial.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 1 2010-07-01 2010-07-01 false Petitions for new trial. 150.22 Section 150.22... trial. (a) Whether submitted to the Judge Advocate General by the accused in propria persona or by counsel for the accused, a petition for new trial submitted while the accused's case is undergoing...

  9. 5 CFR 301.204 - Status and trial period.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Status and trial period. 301.204 Section... EMPLOYMENT Overseas Limited Appointment § 301.204 Status and trial period. (a) An overseas limited employee... she is required to serve a trial period of 1 year when given an overseas limited appointment...

  10. 32 CFR 644.117 - Procedure prior to trial.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Procedure prior to trial. 644.117 Section 644.117... ESTATE HANDBOOK Acquisition Acquisition by Condemnation Proceedings § 644.117 Procedure prior to trial... United States Attorneys in negotiating settlements, preparing cases for trial, and in conducting...

  11. 77 FR 6867 - Practice Guide for Proposed Trial Rules

    Science.gov (United States)

    2012-02-09

    ...Parts 42 and 90 Practice Guide for Proposed Trial Rules...PTO-P-2011-0094] Practice Guide for Proposed Trial Rules...review, the transitional program for covered business...this document a practice guide for the proposed trial...guide should be sent by electronic mail message over...

  12. The Certificate of Secondary Education Trial Examinations: Handicraft.

    Science.gov (United States)

    Schools Council, London (England).

    These trial examinations in handicrafts for certification in secondary education in England are similar to previously published trial examinations in religious knowledge, experimental exams, and the place of the personal topic in history. Half of the booklet deals with (1) the trial examination's history and description, (2) details of the…

  13. Citation bias of hepato-biliary randomized clinical trials

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Gluud, Christian

    2002-01-01

    The objective of this study was to assess whether trials with a positive (i.e., statistically significant) outcome are cited more often than negative trials. We reviewed 530 randomized clinical trials on hepato-biliary diseases published in 11 English-language journals indexed in MEDLINE from 1985...

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

    DEFF Research Database (Denmark)

    Sever, Peter S; Poulter, Neil R; Dahlof, Bjorn; Wedel, Hans; Beevers, Gareth; Caulfield, Mark; Collins, Rory; Kjeldsen, Sverre E; Kristinsson, Arni; McInnes, Gordon; Mehlsen, Jesper; Nieminen, Markku S; O'Brien, Eoin T; Ostergren, Jan

    2008-01-01

    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).

  15. Supportive treatment with megestrol acetate during radio-(chemo-)therapy. A randomized trial

    International Nuclear Information System (INIS)

    Background: The value of megestrol acetate in treating tumor anorexia and cachexia of terminal patients is well known. However, the supportive effect of megestrol acetate during intensive radio-(chemo-)therapy was not investigated up to now. Therefore a randomized trial was performed including patients with advanced tumors in the head and neck region. Patients and Methods: From June 1991 to December 1993 a total of 64 patients were admitted to a randomized, double-blind placebo-controlled study. During and up to 6 weeks following radiotherapy patients received 160 mg/d megestrol acetate or placebo. The nutritional status (anthropometric and laboratory parameters) and the quality-of-life index according to Padilla et al. were determined prior to therapy, 1, 4, 6 weeks later during radiotherapy and 12, 18 weeks after completion. Results: Sixty-one out of 64 patients were evaluable (control group: n=30; megestrol acetate patients: n=31). One patients refused further participation after randomization. One patient in each arm was excluded due to side effects (impotence, diarrhoea). Further side effects were not observed. In the control group the nutrititional parameters (body weight, triceps skinfold) and the subjective feeling of the patients deteriorated during radiotherapy and did not restore following radiotherapy. By contrast, the patients of the megestrol acetate group were able to stabilize these parameters. This difference was most prominent in the orally nourished patients (weight loss during therapy: Control group: -4.1 kg; megestrol acetate group: -0.8 kg; p=0.004); but not in the patients fed by percutaneous endoscopically guided gastrostomy (weight loss control group: -2.4 kg; megestrol acetate group: -0.8 kg; p=0.14). Conclusion: In patients on radiochemotherapy megestrol acetate prevents patients from further deterioration of the nutritional status and quality of life. (orig.)

  16. Adaptive Trial Design: Could We Use This Approach to Improve Clinical Trials in the Field of Global Health?

    OpenAIRE

    Lang, T.

    2011-01-01

    We need more clinical trials in the world's poorest regions to evaluate new drugs and vaccines, and also to find better ways to manage health issues. Clinical trials are expensive, time consuming, and cumbersome. However, in wealthier regions these limiting factors are being addressed to make trials less administrative and improve the designs. A good example is adaptive trial design. This innovation is becoming accepted by the regulators and has been taken up by the pharmaceutical industry to...

  17. Reversal of the neurological deficit in acute stroke with the signal of efficacy trial of auto-BPAP to limit damage from suspected sleep apnea (Reverse-STEAL): study protocol for a randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Although the negative impact of sleep apnea on the clinical course of acute ischemic stroke (AIS) is well known, data regarding non-invasive ventilation in acute patients are scarce. Several studies have shown its tolerability and safety, yet no controlled randomized sequential phase studies exist that aim to establish the efficacy of early non-invasive ventilation in AIS patients. Methods/design We decided to examine our hypothesis that early non-invasive ventilation with auto-titrating bilevel positive airway pressure (auto-BPAP) positively affects short-term clinical outcomes in AIS patients. We perform a multicenter, prospective, randomized, controlled, third rater- blinded, parallel-group trial. Patients with AIS with proximal arterial obstruction and clinically suspected sleep apnea will be randomized to standard stroke care alone or standard stroke care plus auto-BPAP. Auto-BPAP will be initiated within 24 hours of stroke onset and performed for a maximum of 48 hours during diurnal and nocturnal sleep. Patients will undergo unattended cardiorespiratory polygraphy between days three and five to assess sleep apnea. Our primary endpoint will be any early neurological improvement on the NIHSS at 72 hours from randomization. Safety, tolerability, short-term and three-months functional outcomes will be assessed as secondary endpoints by un-blinded and blinded observers respectively. Discussion We expect that this study will advance our understanding of how early treatment with non-invasive ventilation can counterbalance, or possibly reverse, the deleterious effects of sleep apnea in the acute phase of ischemic stroke. The study will provide preliminary data to power a subsequent phase III study. Trial registration Clinicaltrials.gov Identifier: NCT01812993 PMID:23941576

  18. The first documented controlled trial in history.

    Science.gov (United States)

    Koren, Gideon

    2015-01-01

     The first reported controlled human trial was conducted 2500 years ago by the Biblical judge Gideon Ben Yoash, who challenged God's Angel: "I will put a fleece of wool on the threshing floor. If there is dew on the fleece only, and it is dry on all the ground, then I will know that Thou wilt deliver Israel through me, as Thou hast spoken". In the control part of the trial he asked the Angel to keep the wool dry while the ground around it will be soaked with morning dew. It is unfortunate that these principles were not practiced for thousands of years thereafter, as many medical challenges could have been solved earlier.   PMID:25599380

  19. Prostate Cancer Prevention: Concepts and Clinical Trials.

    Science.gov (United States)

    Hamilton, Zachary; Parsons, J Kellogg

    2016-04-01

    Prevention is an important treatment strategy for diminishing prostate cancer morbidity and mortality and is applicable to both early- and late-stage disease. There are three basic classifications of cancer prevention: primary (prevention of incident disease), secondary (identification and treatment of preclinical disease), and tertiary (prevention of progression or recurrence). Based on level I evidence, 5-alpha reductase inhibitors (5-ARIs) should be considered in selected men to prevent incident prostate cancer. Level I evidence also supports the consideration of dutasteride, a 5-ARI, for tertiary prevention in active surveillance and biochemical recurrence patients. Vitamins and supplements, including selenium or vitamin E, have not been proven in clinical trials to prevent prostate cancer and in the case of Vitamin E has been found to increase the risk of incident prostate cancer. Ongoing and future trials may further elucidate the role of diet and immunotherapy for prevention of prostate cancer. PMID:26957512

  20. THE RIGHT TO A FAIR TRIAL

    Directory of Open Access Journals (Sweden)

    FLORICA BRASOVEANU

    2012-05-01

    Full Text Available Among the general rights of the citizen on finds the free access to justice, the rights to defense and the right to legal security. The jurisprudence based on principles of law and on international treaties, caused the appearance, along the constitutional protection provided by default by a lawyer, of the need of fair and equitable procedures to ensure a balance in the rights of the parties. Today the right to a fair trial is a fundamental right most frequently invoked in front of Romanian courts, as in complaints to the European Court of Human Rights. This study is intended as a guide of the most important solutions that have been promoted to ensure the protection of the right to a fair trial with all the guarantees that are involved, starting with the right of access to justice and ending with the right to adversarial proceedings.

  1. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

    Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

  2. Malaria vaccines: lessons from field trials

    Directory of Open Access Journals (Sweden)

    Claudio J. Struchiner

    1994-07-01

    Full Text Available Malaria vaccine candidates have already been tested and new trials are being carried out. We present a brief description of specific issues of validity that are relevant when assessing vaccine efficacy in the field and illustrate how the application of these principles might improve our interpretation of the data being gathered in actual malaria vaccine field trials. Our discussion assumes that vaccine evaluation shares the same general principles of validity with epidemiologic causal inference, i.e., the process of drawing inferences from epidemiologic data aiming at the identification of causes of diseases. Judicious exercise of these principles indicates that, for meaningful interpretation, measures of vaccine efficacy require definitions based upon arguments conditional on the amount of exposure to infection, and specification of the initial and final states in which one believes the effect of interest takes place.

  3. On the Complexity of Trial and Error

    CERN Document Server

    Bei, Xiaohui; Zhang, Shengyu

    2012-01-01

    Motivated by certain applications from physics, biochemistry, economics, and computer science, in which the objects under investigation are not accessible because of various limitations, we propose a trial-and-error model to examine algorithmic issues in such situations. Given a search problem with a hidden input, we are asked to find a valid solution, to find which we can propose candidate solutions (trials), and use observed violations (errors), to prepare future proposals. In accordance with our motivating applications, we consider the fairly broad class of constraint satisfaction problems, and assume that errors are signaled by a verification oracle in the format of the index of a violated constraint (with the content of the constraint still hidden). Our discoveries are summarized as follows. On one hand, despite the seemingly very little information provided by the verification oracle, efficient algorithms do exist for a number of important problems. For the Nash, Core, Stable Matching, and SAT problems,...

  4. Media reporting of tenofovir trials in Cambodia and Cameroon

    Directory of Open Access Journals (Sweden)

    Wong Elaine

    2005-08-01

    Full Text Available Abstract Background Two planned trials of pre-exposure prophylaxis tenofovir in Cambodia and Cameroon to prevent HIV infection in high-risk populations were closed due to activist pressure on host country governments. The international news media contributed substantially as the primary source of knowledge transfer regarding the trials. We aimed to characterize the nature of reporting, specifically focusing on the issues identified by media reports regarding each trial. Methods With the aid of an information specialist, we searched 3 electronic media databases, 5 electronic medical databases and extensively searched the Internet. In addition we contacted stakeholder groups. We included media reports addressing the trial closures, the reasons for the trial closures, and who was interviewed. We extracted data using content analysis independently, in duplicate. Results We included 24 reports on the Cambodian trial closure and 13 reports on the Cameroon trial closure. One academic news account incorrectly reported that it was an HIV vaccine trial that closed early. The primary reasons cited for the Cambodian trial closure were: a lack of medical insurance for trial related injuries (71%; human rights considerations (71%; study protocol concerns (46%; general suspicions regarding trial location (37% and inadequate prevention counseling (29%. The primary reasons cited for the Cameroon trial closure were: inadequate access to care for seroconverters (69%; participants not sufficiently informed of risks (69%; inadequate number of staff (46%; participants being exploited (46% and an unethical study design (38%. Only 3/23 (13% reports acknowledged interviewing research personnel regarding the Cambodian trial, while 4/13 (30.8% reports interviewed researchers involved in the Cameroon trial. Conclusion Our review indicates that the issues addressed and validity of the media reports of these trials is highly variable. Given the potential impact of the media in formulation of health policy related to HIV, efforts are needed to effectively engage the media during periods of controversy in the HIV/AIDS epidemic.

  5. Trial-by-trial adjustments of cognitive control following errors and response conflict are altered in pediatric obsessive compulsive disorder

    Directory of Open Access Journals (Sweden)

    YanniLiu

    2012-05-01

    Full Text Available Background: Impairments of cognitive control have been theorized to drive the repetitive thoughts and behaviors of obsessive compulsive disorder (OCD from early in the course of illness. However, it remains unclear whether altered trial-by-trial adjustment of cognitive control characterizes young patients. To test this hypothesis, we determined whether trial-by-trial adjustments of cognitive control are altered in children with OCD, relative to healthy controls. Methods: Forty-eight patients with pediatric OCD and forty-eight healthy youth performed the Multi-Source Interference Task. Two types of trial-by-trial adjustments of cognitive control were examined: post-error slowing (i.e., slower responses after errors than after correct trials and post-conflict adaptation (i.e., faster responses in high-conflict incongruent trials that are preceded by other high-conflict incongruent trials, relative to low-conflict congruent trials. Results: While healthy youth exhibited both post-error slowing and post-conflict adaptation, patients with pediatric OCD failed to exhibit either of these effects. Further analyses revealed that patients with low symptom severity showed a reversal of the post-conflict adaptation effect, whereas patients with high symptom severity did not show any post-conflict adaptation. Conclusion: Two types of trial-by-trial adjustments of cognitive control are altered in pediatric OCD. These abnormalities may serve as early markers of the illness.

  6. Characterization of Trial-to-Trial Fluctuations in Local Field Potentials Recorded in Cerebral Cortex of Awake Behaving Macaque

    OpenAIRE

    Menzer, David L.; Bokil, Hemant; Ryou, Jae Wook; Schiff, Nicholas D.; Purpura, Keith P.; Mitra, Partha P.

    2009-01-01

    In analyzing neurophysiologic data, individual experimental trials are usually assumed to be statistically independent. However, many studies employing functional imaging and electrophysiology have shown that brain activity during behavioral tasks includes temporally correlated trial-to-trial fluctuations. This could lead to spurious results in statistical significance tests used to compare data from different interleaved behavioral conditions presented throughout an experiment. We characteri...

  7. Competing events and costs of clinical trials: Analysis of a randomized trial in prostate cancer

    International Nuclear Information System (INIS)

    Background: Clinical trial costs may be reduced by identifying enriched subpopulations of patients with favorable risk profiles for the events of interest. However, increased selectivity affects accrual rates, with uncertain impact on clinical trial cost. Methods: We conducted a secondary analysis of Southwest Oncology Group (SWOG) 8794 randomized trial of adjuvant radiotherapy for high-risk prostate cancer. The primary endpoint was metastasis-free survival (MFS), defined as time to metastasis or death from any cause (competing mortality). We used competing risks regression models to identify an enriched subgroup at high risk for metastasis and low risk for competing mortality. We applied a cost model to estimate the impact of enrichment on trial cost and duration. Results: The treatment effect on metastasis was similar in the enriched subgroup (HR, 0.42; 95% CI, 0.23–0.76) compared to the whole cohort (HR, 0.50; 95% CI, 0.30–0.81) while the effect on competing mortality was not significant in the subgroup or the whole cohort (HR 0.70; 95% CI 0.39–1.23, vs. HR 0.94; 95% CI, 0.68–1.31). Due to the higher incidence of metastasis relative to competing mortality in the enriched subgroup, the treatment effect on MFS was greater in the subgroup compared to the whole cohort (HR 0.55; 95% CI 0.36–0.82, vs. HR 0.77; 95% CI, 0.58–1.01). Trial cost was 75% less in the subgroup compared to the whole cohort ($1.7 million vs. $6.8 million), and the trial duration was 30% shorter (8.4 vs. 12.0 years). Conclusion: Competing event enrichment can reduce clinical trial cost and duration, without sacrificing generalizability

  8. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  9. Curcumin: clinical trial finds no antiviral effect.

    Science.gov (United States)

    James, J S

    1996-03-01

    A New England clinical trial examined curcumin and its effectiveness as an antiviral agent in 40 participants. Viral load tests, including baseline testing, were conducted in the fourth and eighth weeks, following high- and low-dose regimens. The study found no evidence that curcumin reduced viral load or increased CD4 counts. Despite this finding, patients claimed they liked taking curcumin because they felt better and were willing to put up with the minor gastrointestinal effects. PMID:11363190

  10. Interpretation of Subgroup Effects in Published Trials

    DEFF Research Database (Denmark)

    Hancock, Mark J; Kjær, Per; Korsholm, Lars; Kent, Peter

    2013-01-01

    With the rapidly expanding number of studies reporting on treatment subgroups come new challenges in analyzing and interpreting this sometimes complex area of the literature. This article discusses 3 important issues regarding the analysis and interpretation of existing trials or systematic reviews that report on treatment effect modifiers (subgroups) for specific physical therapy interventions. The key messages are: (1) point estimates of treatment modifier effect size (interaction effect) and ...

  11. Alternative methods to evaluate trial level surrogacy

    OpenAIRE

    CORTINAS ABRAHANTES, Jose; SHKEDY, Ziv; Molenberghs, Geert

    2008-01-01

    Background The evaluation and validation of surrogate endpoints have been extensively studied in the last decade. Prentice [1] and Freedman, Graubard and Schatzkin [2] laid the foundations for the evaluation of surrogate endpoints in randomized clinical trials. Later, Buyse et al. [5] proposed a meta-analytic methodology, producing different methods for different settings, which was further studied by Alonso and Molenberghs [9], in their unifying approach based on information theory. Purpose ...

  12. Efficient designs of multiple sclerosis clinical trials

    OpenAIRE

    Vrecko, Dean Emile

    2007-01-01

    Multiple sclerosis (MS) is a debilitating disease that attacks the central nervous system. Much research has been conducted to investigate the efficacy of various treatments in reducing the number of active brain lesions in patients, an indicator of disease activity. However, there has been little research regarding the time series nature of these lesion counts. This project focuses on sample size recommendations for Phase II MS/MRI clinical trials using a longitudinal model. We explore desig...

  13. Trial NCT02169271 | Division of Cancer Prevention

    Science.gov (United States)

    This randomized phase II trial studies acetylsalicylic acid compared to placebo in treating high-risk patients with subsolid lung nodules. A nodule is a growth or lump that may be malignant (cancer) or benign (not cancer). Chemoprevention is the use of drugs to keep cancer from forming or coming back. The use of acetylsalicylic acid may keep cancer from forming in patients with subsolid lung nodules.

  14. Clinical trials--a brave new partnership?

    OpenAIRE

    Thornton, H

    1994-01-01

    The need for informed consent is considered from the patient's viewpoint by an examination of the shortcomings of the UK Ductal Carcinoma In Situ (DCIS) trial and its failure satisfactorily to accrue both profession and patient. The impersonal, negative aspects of the informed consent process in the research situation are contrasted with the positive benefits of confidence fostered by the traditional doctor/patient relationship. The need for new research with a partnership between patient and...

  15. Application of trial risk acceptance criteria

    International Nuclear Information System (INIS)

    The objective of this paper is to investigate some of the implications inherent in the application of various proposed sets of risk acceptance criteria. A power-law model of risk aversion is utilized to estimate the equivalent number of individual deaths and is treated parametrically. The implications of ALARA requirements for cost-effective improvements are also illustrated. The risks assessed for various technological endeavors, as well as some estimated natural background risks, are compared to the trial criteria

  16. Personalized Medicine: Genomics Trials in Oncology

    OpenAIRE

    Hayes, Daniel F.; Schott, Anne F

    2015-01-01

    The era of genomics-based medicine promises to provide molecular tests that will permit precision medicine. However, in 2015, it is not clear what the terms genomics-based medicine, molecular tests, or precision medicine mean. In this report, we review the definitions of these terms and other important semantics relative to what it takes to get a tumor biomarker into standard clinical practice, and the potential clinical trial designs that are being considered to determine if tumor biomarker ...

  17. MR Imaging Biomarkers in Oncology Clinical Trials.

    Science.gov (United States)

    Abramson, Richard G; Arlinghaus, Lori R; Dula, Adrienne N; Quarles, C Chad; Stokes, Ashley M; Weis, Jared A; Whisenant, Jennifer G; Chekmenev, Eduard Y; Zhukov, Igor; Williams, Jason M; Yankeelov, Thomas E

    2016-02-01

    The authors discuss eight areas of quantitative MR imaging that are currently used (RECIST, DCE-MR imaging, DSC-MR imaging, diffusion MR imaging) in clinical trials or emerging (CEST, elastography, hyperpolarized MR imaging, multiparameter MR imaging) as promising techniques in diagnosing cancer and assessing or predicting response of cancer to therapy. Illustrative applications of the techniques in the clinical setting are summarized before describing the current limitations of the methods. PMID:26613873

  18. Balance algorithm for cluster randomized trials

    OpenAIRE

    Hood Kerenza; Carter Ben R

    2008-01-01

    Abstract Background Within cluster randomized trials no algorithms exist to generate a full enumeration of a block randomization, balancing for covariates across treatment arms. Furthermore, often for practical reasons multiple blocks are required to fully randomize a study, which may not have been well balanced within blocks. Results We present a convenient and easy to use randomization tool to undertake allocation concealed block randomization. Our algorithm highlights allocations that mini...

  19. Northwestern University trial emerging optical solutions

    CERN Multimedia

    2001-01-01

    Nortel Networks, SBC Ameritech and Northwestern University announced the creation of OMNInet (Optical Metro Network Initiative), a collaborative experimental network. The OMNInet technology trial, a four-site network located in Chicago, will provide a test bed for all-optical switching, advanced high-speed technology such as 10 gigabit Ethernet (10GE) and will test next-generation applications in healthcare, industrial design, finance and commerce.

  20. Activating clinical trials: a process improvement approach

    OpenAIRE

    Martinez, Diego A.; Tsalatsanis, Athanasios; Yalcin, Ali; Zayas-Castro, José L.; Djulbegovic, Benjamin

    2016-01-01

    Background The administrative process associated with clinical trial activation has been criticized as costly, complex, and time-consuming. Prior research has concentrated on identifying administrative barriers and proposing various solutions to reduce activation time, and consequently associated costs. Here, we expand on previous research by incorporating social network analysis and discrete-event simulation to support process improvement decision-making. Methods We searched for all operatio...

  1. Future of Clinical Trials in Nepal

    OpenAIRE

    Brijesh Sathian

    2011-01-01

    Nowadays the output—and rewards—of research are based almost entirely on published papers in scientific journals. Scientists in low-income and middle-income settings would like to conduct research for their populations according to their own concerns. They want to be in the frontlines of national and global communications about their country’s experiences. I recommend that properly trained clinical trial experts from developed countries should conduct some workshops on the design, conduct an...

  2. Ethics of clinical trials in Nigeria

    OpenAIRE

    Okonta, Patrick I

    2014-01-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of c...

  3. [Medical nutrition in Alzheimer's: the trials].

    Science.gov (United States)

    Scheltens, Philip; Twisk, Jos W R

    2013-01-01

    We describe the small but statistically significant effects of the medical nutrition diet 'Souvenaid' on memory in early Alzheimer's disease in two published randomised clinical trials. We specifically discuss the design and statistical approach, which were predefined and meet current standards in the field. Further research is needed to substantiate the long term effects and learn more about the mode of action of Souvenaid. PMID:24326116

  4. Causal Mediation Analyses for Randomized Trials

    OpenAIRE

    Lynch, Kevin G.; CARY, Mark; Gallop, Robert; Ten Have, Thomas R.

    2008-01-01

    In the context of randomized intervention trials, we describe causal methods for analyzing how post-randomization factors constitute the process through which randomized baseline interventions act on outcomes. Traditionally, such mediation analyses have been undertaken with great caution, because they assume that the mediating factor is also randomly assigned to individuals in addition to the randomized baseline intervention (i.e., sequential ignorability). Because the mediating factors are t...

  5. The metabolic and endocrine response and health implications of consuming sugar-sweetened beverages: findings from recent randomized controlled trials.

    Science.gov (United States)

    Rippe, James M

    2013-11-01

    Fructose-containing sugars, including fructose itself, high fructose corn syrup (HFCS), and sucrose have engendered considerable controversy. The effects of HFCS and sucrose in sugar-sweetened beverages, in particular, have generated intense scientific debate that has spilled over to the public. This controversy is related to well-known differences in metabolism between fructose and glucose in the liver. In addition, research studies have often been conducted comparing pure fructose and pure glucose even though neither is consumed to any appreciable degree in isolation in the human diet. Other evidence has been drawn from animal studies and epidemiologic or cohort studies. Few randomized controlled trials (RCTs) have compared HFCS with sucrose (the 2 sugars most commonly consumed in the human diet) at dosage amounts within the normal human consumption range. This review compares results of recently concluded RCTs with other forms of evidence related to fructose, HFCS, and sucrose. We conclude that great caution must be used when suggesting adverse health effects of consuming these sugars in the normal way they are consumed and at the normal amounts in the human diet, because RCTs do not support adverse health consequences at these doses when employing these sugars. PMID:24228199

  6. Modernizing Eligibility Criteria for Molecularly Driven Trials.

    Science.gov (United States)

    Kim, Edward S; Bernstein, David; Hilsenbeck, Susan G; Chung, Christine H; Dicker, Adam P; Ersek, Jennifer L; Stein, Steven; Khuri, Fadlo R; Burgess, Earle; Hunt, Kelly; Ivy, Percy; Bruinooge, Suanna S; Meropol, Neal; Schilsky, Richard L

    2015-09-01

    As more clinical trials of molecularly targeted agents evolve, the number of eligibility criteria seems to be increasing. The importance and utility of eligibility criteria must be considered in the context of the fundamental goal of a clinical trial: to understand the risks and benefits of a treatment in the intended-use patient population. Although eligibility criteria are necessary to define the population under study and conduct trials safely, excessive requirements may severely restrict the population available for study, and often, this population is not reflective of the general population for which the drug would be prescribed. The American Society of Clinical Oncology Cancer Research Committee, which comprises academic faculty, industry representatives, and patient advocates, evaluated this issue. Evaluation results were mixed. Most physicians agreed that excessive eligibility criterias slow study enrollment rates and prolong the duration of enrollment; however, this hypothesis was difficult to validate with the data examined. We propose the organization of a public workshop, with input from regulatory bodies and key stakeholders, with the goal of developing an algorithmic approach to determining eligibility criteria for individual study protocols, which may help guide future investigators and companies in streamlining eligibility criteria in the era of molecularly driven therapy. PMID:26195710

  7. European Nicotinamide Diabetes Intervention Trial (ENDIT)

    DEFF Research Database (Denmark)

    Gale, E A M; Bingley, P J; Emmett, C L; Collier, T; Reimers, Jesper Irving

    2004-01-01

    assess whether high dose nicotinamide prevents or delays clinical onset of diabetes in people with a first-degree family history of type 1 diabetes. METHOD: We did a randomised double-blind placebo-controlled trial of nicotinamide in 552 relatives with confirmed islet cell antibody (ICA) levels of 20...... the treatment groups. Of 159 participants who developed diabetes in the course of the trial, 82 were taking nicotinamide and 77 were on placebo. The unadjusted hazard ratio for development of diabetes was 1.07 (95% CI 0.78-1.45; p=0.69), and the hazard ratio adjusted for age-at-entry, baseline glucose...... tolerance, and number of islet autoantibodies detected was 1.01 (0.73-1.38; p=0.97). Of 168 (30.4%) participants who withdrew from the trial, 83 were on placebo. The number of serious adverse events did not differ between treatment groups. Nicotinamide treatment did not affect growth in children or first...

  8. Neuroprotection Trials in Traumatic Brain Injury.

    Science.gov (United States)

    Chakraborty, Shamik; Skolnick, Brett; Narayan, Raj K

    2016-04-01

    Traumatic brain injury (TBI) is a significant cause of mortality and morbidity worldwide. Current treatment of acute TBI includes surgical intervention when needed, followed by supportive critical care such as optimizing cerebral perfusion, preventing pyrexia, and treating raised intracranial pressure. While effective in managing the primary injury to the brain and skull, these treatment modalities do not address the complex secondary cascades that occur at a cellular level following initial injury and greatly affect the ultimate neurologic outcome. These secondary processes involve changes in ionic flux, disruption of cellular function, derangement of blood flow and the blood-brain barrier, and elevated levels of free radicals. Over the past few decades, numerous pharmacologic agents and modalities have been investigated in an attempt to interrupt these secondary processes. No neuroprotective agents currently exist that have been proven to improve neurologic outcome following TBI. However, these trials have contributed significantly to the understanding of the clinical sequelae of TBI and to improvements in the quality of care for TBI. With the experience and insights that have been accrued with the trials to date, we will be able to optimize future trial designs and refine established neurologic endpoints to better identify new therapeutic agents and further improve neurologic outcomes from this often devastating condition. PMID:26883431

  9. The WHO Global Programme for Vaccines and Immunization Vaccine Trial Registry.

    OpenAIRE

    Robertson, S E; Mayans, M. V.; S. Horsfall; Wright, P. F.; Clemens, J.; Ivanoff, B.; P. H. Lambert

    1997-01-01

    In 1995, the WHO Global Programme for Vaccines and Immunization established a Vaccine Trial Registry. As of September 1996, this registry included 50 WHO-supported vaccine trials, of which 25 (50%) were completed studies. The vaccines most frequently tested have been against measles (9 trials), poliovirus (8 trials), cholera (8 trials), enterotoxigenic Escherichia coli (4 trials), and pneumococcus (4 trials). Nearly 80% of these trials have been conducted in developing countries, with the lar...

  10. Electronic Cigarette Trial and Use among Young Adults: Reasons for Trial and Cessation of Vaping

    Directory of Open Access Journals (Sweden)

    Lois Biener

    2015-12-01

    Full Text Available This paper identifies predictors of trial and current use, and reasons for trying and ceasing use of electronic cigarettes (e-cigarettes among young adults, with particular attention to former and never smokers. Data are from a mail survey of a population-based sample of adults aged 18 to 35 (N = 4740 in three U.S. metropolitan areas. Survey items assessed trial and use of e-cigarettes, cigarette smoking status, and reasons for trial and for ceasing use of e-cigarettes. Almost 23% reported trial of e-cigarettes, and 8.4% reported using them in the past month. Current smokers were much more likely to have tried e-cigarettes (70.2% than both former (32.3% and never smokers (7.6%; p < 0.001 and to have used them in the past month (30.8%, 10.1%, 2.0% respectively; p < 0.001. Smoking status and scores on sensation seeking were significant independent predictors of both trial and current use of e-cigarettes. Never-smokers cite curiosity as the reason for trying e-cigarettes and also that their friends used them. The most frequent reason for ceasing use among never and former smokers was health concerns. For virtually none of them were e-cigarettes their first exposure to nicotine.

  11. Electronic Cigarette Trial and Use among Young Adults: Reasons for Trial and Cessation of Vaping.

    Science.gov (United States)

    Biener, Lois; Song, Eunyoung; Sutfin, Erin L; Spangler, John; Wolfson, Mark

    2015-01-01

    This paper identifies predictors of trial and current use, and reasons for trying and ceasing use of electronic cigarettes (e-cigarettes) among young adults, with particular attention to former and never smokers. Data are from a mail survey of a population-based sample of adults aged 18 to 35 (N = 4740) in three U.S. metropolitan areas. Survey items assessed trial and use of e-cigarettes, cigarette smoking status, and reasons for trial and for ceasing use of e-cigarettes. Almost 23% reported trial of e-cigarettes, and 8.4% reported using them in the past month. Current smokers were much more likely to have tried e-cigarettes (70.2%) than both former (32.3%) and never smokers (7.6%; p < 0.001) and to have used them in the past month (30.8%, 10.1%, 2.0% respectively; p < 0.001). Smoking status and scores on sensation seeking were significant independent predictors of both trial and current use of e-cigarettes. Never-smokers cite curiosity as the reason for trying e-cigarettes and also that their friends used them. The most frequent reason for ceasing use among never and former smokers was health concerns. For virtually none of them were e-cigarettes their first exposure to nicotine. PMID:26694438

  12. Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses

    DEFF Research Database (Denmark)

    Kjaergard, L L; Villumsen, J; Gluud, C

    2001-01-01

    To explore whether reported methodologic quality affects estimated intervention effects in randomized trials and contributes to discrepancies between the results of large randomized trials and small randomized trials in meta-analyses.......To explore whether reported methodologic quality affects estimated intervention effects in randomized trials and contributes to discrepancies between the results of large randomized trials and small randomized trials in meta-analyses....

  13. Inter-Trial Contingencies in Contingent-Capture Experiments.

    Science.gov (United States)

    Goller, Florian; Ansorge, Ulrich

    2015-09-01

    Several studies showed that attention can be captured in a top-down contingent way. Here, attention capture by cues depended on a match of cues' features to the features of the searched-for targets. However, the influence of the cue-target position relations in a preceding trial n-1 has not been considered in most studies, although these relations can have an influence: Cueing effects in a trial n can be larger if the preceding trial n-1 was valid rather than invalid (Gratton Effect). Such inter-trial contingencies could contribute to contingent-capture effects, but this was never tested. The aim of our study was to fill this gap. We used the classic contingent-capture protocol and analysed cueing effects in trial n as a function of cue validity (valid versus invalid) and cue type (matching versus non-matching) in trial n-1. In Experiment 1, participants searched for a white onset target. A valid cue in trial n-1 boosted the cuing effect in a subsequent trial n, which indicates a Gratton effect. Surprisingly, these inter-trial contingencies did not hold for matching onset cues but only for non-matching red color cues. Similar effects of the non-matching cues were also found if cues and targets both changed their positions from trial to trial, rendering position priming as an unlikely explanation (Experiment 2). However, no inter-trial contingencies were found during search for red color targets (Experiment 3). In an additional experiment, we explored whether task difficulty may be an important moderator for inter-trial contingencies in the contingent-capture paradigm. Our results provide a new perspective on contingent capture and add to the growing literature on the importance of inter-trial contingencies. Meeting abstract presented at VSS 2015. PMID:26326002

  14. Electronic search strategies to identify reports of cluster randomized trials in MEDLINE: low precision will improve with adherence to reporting standards

    Directory of Open Access Journals (Sweden)

    Grimshaw Jeremy M

    2010-02-01

    Full Text Available Abstract Background Cluster randomized trials (CRTs present unique methodological and ethical challenges. Researchers conducting systematic reviews of CRTs (e.g., addressing methodological or ethical issues require efficient electronic search strategies (filters or hedges to identify trials in electronic databases such as MEDLINE. According to the CONSORT statement extension to CRTs, the clustered design should be clearly identified in titles or abstracts; however, variability in terminology may make electronic identification challenging. Our objectives were to (a evaluate sensitivity ("recall" and precision of a well-known electronic search strategy ("randomized controlled trial" as publication type with respect to identifying CRTs, (b evaluate the feasibility of new search strategies targeted specifically at CRTs, and (c determine whether CRTs are appropriately identified in titles or abstracts of reports and whether there has been improvement over time. Methods We manually examined a wide range of health journals to identify a gold standard set of CRTs. Search strategies were evaluated against the gold standard set, as well as an independent set of CRTs included in previous systematic reviews. Results The existing strategy (randomized controlled trial.pt is sensitive (93.8% for identifying CRTs, but has relatively low precision (9%, number needed to read 11; the number needed to read can be halved to 5 (precision 18.4% by combining with cluster design-related terms using the Boolean operator AND; combining with the Boolean operator OR maximizes sensitivity (99.4% but would require 28.6 citations read to identify one CRT. Only about 50% of CRTs are clearly identified as cluster randomized in titles or abstracts; approximately 25% can be identified based on the reported units of randomization but are not amenable to electronic searching; the remaining 25% cannot be identified except through manual inspection of the full-text article. The proportion of trials clearly identified has increased from 28% between the years 2000-2003, to 60% between 2004-2007 (absolute increase 32%, 95% CI 17 to 47%. Conclusions CRTs should include the phrase "cluster randomized trial" in titles or abstracts; this will facilitate more accurate indexing of the publication type by reviewers at the National Library of Medicine, and efficient textword retrieval of the subset employing cluster randomization.

  15. Homeopathic pathogenetic trial of Plumbum metallicum: the complete 2000 trial with a synthesis of the original 1828 trial

    OpenAIRE

    Christa Pichler; Andrea Maria Signorini

    2011-01-01

    Background: in a previous paper we reported the statistical analysis and other distribution data of a homeopathic pathogenetic trial (HPT) of Plumbum metallicum 30cH carried out by our group. However, at that time we did not report the resulting pure materia medica, i.e., the totality of symptoms elicited by the tested medicine on healthy volunteers. Aim: to communicate to the homeopathic community the full record of symptoms collected in our HPT of Plb. Methods: methods to collect and select...

  16. Clinical trial designs for predictive marker validation in cancer treatment trials.

    Science.gov (United States)

    Sargent, Daniel J; Conley, Barbara A; Allegra, Carmen; Collette, Laurence

    2005-03-20

    Current staging and risk-stratification methods in oncology, while helpful, fail to adequately predict malignancy aggressiveness and/or response to specific treatment. Increased knowledge of cancer biology is generating promising marker candidates for more accurate diagnosis, prognosis assessment, and therapeutic targeting. To apply these exciting results to maximize patient benefit, a disciplined application of well-designed clinical trials for assessing the utility of markers should be used. In this article, we first review the major issues to consider when designing a clinical trial assessing the usefulness of a predictive marker. We then present two classes of clinical trial designs: the Marker by Treatment Interaction Design and the Marker-Based Strategy Design. In the first design, we assume that the marker splits the population into groups in which the efficacy of a particular treatment will differ. This design can be viewed as a classical randomized clinical trial with upfront stratification for the marker. In the second design, after the marker status is known, each patient is randomly assigned either to have therapy determined by their marker status or to receive therapy independent of marker status. The predictive value of the marker is assessed by comparing the outcome of all patients in the marker-based arm to that of all of the patients in the non-marker-based arm. We present detailed sample size calculations for a specific clinical scenario. We discuss the advantages and disadvantages of the two trial designs and their appropriateness to specific clinical situations to assist investigators seeking to design rigorous, marker-based clinical trials. PMID:15774793

  17. ClinicalTrials.gov as a Data Source for Semi-Automated Point-Of-Care Trial Eligibility Screening

    Science.gov (United States)

    Pfiffner, Pascal B.; Oh, JiWon; Miller, Timothy A.; Mandl, Kenneth D.

    2014-01-01

    Background Implementing semi-automated processes to efficiently match patients to clinical trials at the point of care requires both detailed patient data and authoritative information about open studies. Objective To evaluate the utility of the ClinicalTrials.gov registry as a data source for semi-automated trial eligibility screening. Methods Eligibility criteria and metadata for 437 trials open for recruitment in four different clinical domains were identified in ClinicalTrials.gov. Trials were evaluated for up to date recruitment status and eligibility criteria were evaluated for obstacles to automated interpretation. Finally, phone or email outreach to coordinators at a subset of the trials was made to assess the accuracy of contact details and recruitment status. Results 24% (104 of 437) of trials declaring on open recruitment status list a study completion date in the past, indicating out of date records. Substantial barriers to automated eligibility interpretation in free form text are present in 81% to up to 94% of all trials. We were unable to contact coordinators at 31% (45 of 146) of the trials in the subset, either by phone or by email. Only 53% (74 of 146) would confirm that they were still recruiting patients. Conclusion Because ClinicalTrials.gov has entries on most US and many international trials, the registry could be repurposed as a comprehensive trial matching data source. Semi-automated point of care recruitment would be facilitated by matching the registry's eligibility criteria against clinical data from electronic health records. But the current entries fall short. Ultimately, improved techniques in natural language processing will facilitate semi-automated complex matching. As immediate next steps, we recommend augmenting ClinicalTrials.gov data entry forms to capture key eligibility criteria in a simple, structured format. PMID:25334031

  18. Key concepts of clinical trials: a narrative review.

    Science.gov (United States)

    Umscheid, Craig A; Margolis, David J; Grossman, Craig E

    2011-09-01

    The recent focus of federal funding on comparative effectiveness research underscores the importance of clinical trials in the practice of evidence-based medicine and health care reform. The impact of clinical trials not only extends to the individual patient by establishing a broader selection of effective therapies, but also to society as a whole by enhancing the value of health care provided. However, clinical trials also have the potential to pose unknown risks to their participants, and biased knowledge extracted from flawed clinical trials may lead to the inadvertent harm of patients. Although conducting a well-designed clinical trial may appear straightforward, it is founded on rigorous methodology and oversight governed by key ethical principles. In this review, we provide an overview of the ethical foundations of trial design, trial oversight, and the process of obtaining approval of a therapeutic, from its pre-clinical phase to post-marketing surveillance. This narrative review is based on a course in clinical trials developed by one of the authors (DJM), and is supplemented by a PubMed search predating January 2011 using the keywords "randomized controlled trial," "patient/clinical research," "ethics," "phase IV," "data and safety monitoring board," and "surrogate endpoint." With an understanding of the key principles in designing and implementing clinical trials, health care providers can partner with the pharmaceutical industry and regulatory bodies to effectively compare medical therapies and thereby meet one of the essential goals of health care reform. PMID:21904102

  19. Patient Income Level and Cancer Clinical Trial Participation

    Science.gov (United States)

    Unger, Joseph M.; Hershman, Dawn L.; Albain, Kathy S.; Moinpour, Carol M.; Petersen, Judith A.; Burg, Kenda; Crowley, John J.

    2013-01-01

    Purpose Studies have shown an association between socioeconomic status (SES) and quality of oncology care, but less is known about the impact of patient SES on clinical trial participation. Patients and Methods We assessed clinical trial participation patterns according to important SES (income, education) and demographic factors in a large sample of patients surveyed via an Internet-based treatment decision tool. Logistic regression, conditioning on type of cancer, was used. Attitudes toward clinical trials were assessed using prespecified items about treatment, treatment tolerability, convenience, and cost. Results From 2007 to 2011, 5,499 patients were successfully surveyed. Forty percent discussed clinical trials with their physician, 45% of discussions led to physician offers of clinical trial participation, and 51% of offers led to clinical trial participation. The overall clinical trial participation rate was 9%. In univariate models, older patients (P = .002) and patients with lower income (P = .001) and education (P = .02) were less likely to participate in clinical trials. In a multivariable model, income remained a statistically significant predictor of clinical trial participation (odds ratio, 0.73; 95% CI, 0.57 to 0.94; P = .01). Even in patients age ? 65 years, who have universal access to Medicare, lower income predicted lower trial participation. Cost concerns were much more evident among lower-income patients (P < .001). Conclusion Lower-income patients were less likely to participate in clinical trials, even when considering age group. A better understanding of why income is a barrier may help identify ways to make clinical trials better available to all patients and would increase the generalizability of clinical trial results across all income levels. PMID:23295802

  20. Bicycle weight and commuting time: randomised trial

    OpenAIRE

    Groves, J

    2010-01-01

    Objective To determine whether the author’s 20.9 lb (9.5 kg) carbon frame bicycle reduced commuting time compared with his 29.75 lb (13.5 kg) steel frame bicycle. Design Randomised trial. Setting Sheffield and Chesterfield, United Kingdom, between mid-January 2010 and mid-July 2010. Participants One consultant in anaesthesia and intensive care. Main outcome measure Total time to complete the 27 mile (43.5 kilometre) journey from Sheffield to Chesterfield Royal Hospital and back. Results The t...

  1. Eurados trial performance test for photon dosimetry

    DEFF Research Database (Denmark)

    Stadtmann, H.; Bordy, J.M.; Ambrosi, P.; Bartlett, D.T.; Christensen, P.; Colgan, T.; Hyvonen, H.

    Within the framework of the EURADOS Action entitled Harmonisation and Dosimetric Quality Assurance in Individual Monitoring for External Radiation, trial performance tests for whole-body and extremity personal dosemeters were carried out. Photon, beta and neutron dosemeters were considered. This...... 312 single results, 26 fell outside the limits of the trumpet curve and 32 were outside the range 1/1.5 to 1.5. Most outliers resulted from high energy R-F irradiations without electronic equilibrium. These fields are not routinely encountered by many of the participating dosimetry services. If the...

  2. Feeding trials of green seaweed Ulva fasciata

    OpenAIRE

    Alam, J.M.; Qasim, R.

    1993-01-01

    For the nutritional evaluation of green seaweed Ulva fasciata, a feeding trial was performed in albino rats. The results indicated that the 20% replacement of seaweed U. fasciata instead of carrot or lettuce in rad diet causes no harmful effects, as evident by a non-significant change in blood constituents and serum enzyme levels. The weight gain observed in rats with U. fasciata diet was same as that of control diet. The true digestibility ratio of U. fasciata was 80.20% with carrot and 83.4...

  3. Inactive trials of transport systems: phase II

    International Nuclear Information System (INIS)

    Progress made during 1984-85 is reviewed in four sections: the design and installation of a stainless steel working floor in the mock-up of a crate handling and size reduction facility; the detailed evaluation of a single air pad of the type used on commercial air-transporter; an experimental programme designed to examine the problems associated with the operation of a commercial air-transporter; the design, manufacture and commissioning trials of two powered conveyor units which when combined complete a remotely operated transfer system for transporting crated waste into and within the mock-up facility. (author)

  4. Analysis and correction of sea trials

    OpenAIRE

    Haakenstad, Katharina

    2012-01-01

    When a ship-owner orders a vessel from a shipyard, a contract is written to confirm and guarantee the agreement for both parts. An important requirement of the contract is the vessel's speed at a given engine power, RPM and draught, in "ideal" conditions (i.e. calm, infinitely deep and current free water, with smooth hull and propeller surfaces at with no wind and zero drift and rudder angle). The speed capacity of the recently built ship is measured carrying out a speed trial....

  5. Credentialing Institutions for Advanced Technology Clinical Trials

    International Nuclear Information System (INIS)

    The Radiological Physics Center (RPC) is charged with assuring the consistent delivery of radiation doses to patients on NCI sponsored clinical trials. To accomplish this, the RPC conducts annual mailed audits of machine calibration, dosimetry audit visits to institutions, reviews of treatment records, and credentialing procedures requiring the irradiation of anthropomorphic phantoms. Through these measurements, the RPC has gained an understanding of the level of quality assurance (QA) practised in this cohort of institutions, and a database of measurements of beam characteristics of a large number of treatment machines. The results of irradiations of phantoms have yielded insight into the delivery of advanced technology treatment procedures. (author)

  6. The Electronic Evidence in Trial Proceedings

    Directory of Open Access Journals (Sweden)

    Monica Pocora

    2015-05-01

    Full Text Available This paper will consider theoretical and practical issues which arise in trial proceedings, throughout the virtual presence of persons involved. The EU Convention of 2000 provide the legal base for the use of video conference. In most jurisdictions, all forms of evidence is admissible, subject to rules relating to the exclusion of evidence because of improper actions or because the inclusion of the evidence would be unfair to the defendant. There is a difference between the admissibility of the evidence and laying the correct foundations before the evidence can be admitted.

  7. InovCity – structure of trials evaluation

    OpenAIRE

    Moreira, Inês Almeida Campos

    2012-01-01

    In 2007, the UK government commissioned the Energy Demand Research Project to conduct a large scale experiment of smart metering technologies to test the impacts from many different forms of feedback to residential consumers. A full evaluation of the results was completed in 2011. In Portugal, EDP is also conducting smart meter trials in a project called InovCity in the city of Évora whose results will be evaluated during 2012. In this work, the case of Great Britain is studied as a refere...

  8. 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

    Background 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. Methods 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. Results 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). Conclusions The quality of published outcome analysis definitions and trial registrations in JCCP is suboptimal. Greater attention to proper trial registration and outcome analysis definition in published reports is needed. PMID:26581079

  9. Examining the clinical trial feasibility process and its implications for a trial site

    Directory of Open Access Journals (Sweden)

    Burgess LJ

    2011-09-01

    Full Text Available LJ Burgess, NU SulzerTREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and Stellenbosch University, Parow, South AfricaObjectives: To retrospectively analyze feasibility questionnaires to evaluate the number of trials that resulted in patient enrolment and the mean time frame involved.Methods: This study was conducted by TREAD Research, a site-managed organization based in the Western Cape, South Africa, between January 2004 and December 2009. All feasibility questionnaires received by the site over this time period were analyzed. Descriptive statistics were used to analyze the data.Results: A total of 252 feasibility questionnaires were received; 207 were accepted and 45 rejected. An average of 26.8% of trials started out of those feasibilities that were accepted by the site. The average time frame from feasibility acceptance to patient enrolment was 12.9 months (range 2.7–33.5 months.Conclusion: Improving the trial feasibility process would markedly improve a trial site’s ability to plan effectively and efficiently allocate appropriate resources.Keywords: resource allocation, business planning, clinical research organizations

  10. Revisiting sample size: are big trials the answer?

    Science.gov (United States)

    Lurati Buse, Giovanna A L; Botto, Fernando; Devereaux, P J

    2012-07-18

    The superiority of the evidence generated in randomized controlled trials over observational data is not only conditional to randomization. Randomized controlled trials require proper design and implementation to provide a reliable effect estimate. Adequate random sequence generation, allocation implementation, analyses based on the intention-to-treat principle, and sufficient power are crucial to the quality of a randomized controlled trial. Power, or the probability of the trial to detect a difference when a real difference between treatments exists, strongly depends on sample size. The quality of orthopaedic randomized controlled trials is frequently threatened by a limited sample size. This paper reviews basic concepts and pitfalls in sample-size estimation and focuses on the importance of large trials in the generation of valid evidence. PMID:22810453

  11. Statistical challenges for central monitoring in clinical trials: a review.

    Science.gov (United States)

    Oba, Koji

    2016-02-01

    Recently, the complexity and costs of clinical trials have increased dramatically, especially in the area of new drug development. Risk-based monitoring (RBM) has been attracting attention as an efficient and effective trial monitoring approach, which can be applied irrespectively of the trial sponsor, i.e., academic institution or pharmaceutical company. In the RBM paradigm, it is expected that a statistical approach to central monitoring can help improve the effectiveness of on-site monitoring by prioritizing and guiding site visits according to central statistical data checks, as evidenced by examples of actual trial datasets. In this review, several statistical methods for central monitoring are presented. It is important to share knowledge about the role and performance capabilities of statistical methodology among clinical trial team members (i.e., sponsors, investigators, data managers, monitors, and biostatisticians) in order to adopt central statistical monitoring for assessing data quality in the actual clinical trial. PMID:26499195

  12. Good clinical practice: International quality standard for clinical trials

    Directory of Open Access Journals (Sweden)

    Radulovi? Siniša S.

    2003-01-01

    Full Text Available A clinical trial is one of the most important examples of experimental studies. Clinical trials represent an indispensable tool for testing, in a rigorous scientific manner, the efficacy of new therapies. Good Clinical Practice is an international ethical and scientific quality standard for clinical trials, concerning the design, conduct, performance, monitoring auditing, recording, analysis and reporting. This is an assurance to the public that the rights, safety and well-being of trial subjects are protected, and that clinical trial data is credible. The above definitions are consistent with the principles that have their origin in the declaration of Helsinki. The objectives of Good Clinical Practice are to protect the rights of trial subjects, to enhance credibility of data and to improve the quality of science.

  13. Practical considerations for adaptive trial design and implementation

    CERN Document Server

    Pinheiro, José; Kuznetsova, Olga

    2014-01-01

    This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers.  In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low.  One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, t...

  14. Citation bias of hepato-biliary randomized clinical trials

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Gluud, Christian

    2002-01-01

    The objective of this study was to assess whether trials with a positive (i.e., statistically significant) outcome are cited more often than negative trials. We reviewed 530 randomized clinical trials on hepato-biliary diseases published in 11 English-language journals indexed in MEDLINE from 1985-1996. From each trial, we extracted the statistical significance of the primary study outcome (positive or negative), the disease area, and methodological quality (randomization and double blinding). The number of citations during two calendar years after publication was obtained from Science Citation Index. There was a significant positive association between a statistically significant study outcome and the citation frequency (beta, 0.55, 95% confidence interval, 0.39-0.72). The disease area and adequate generation of the allocation sequence were also significant predictors of the citation frequency. We concluded that positive trials are cited significantly more often than negative trials. The association was not explained by disease area or methodological quality.

  15. Minimal clinically important differences in pharmacological trials.

    Science.gov (United States)

    Jones, Paul W; Beeh, Kai M; Chapman, Kenneth R; Decramer, Marc; Mahler, Donald A; Wedzicha, Jadwiga A

    2014-02-01

    The concept of a minimal clinically important difference (MCID) is well established. Here, we review the evidence base and methods used to define MCIDs as well as their strengths and limitations. Most MCIDs in chronic obstructive pulmonary disease (COPD) are empirically derived estimates applying to populations of patients. Validated MCIDs are available for many commonly used outcomes in COPD, including lung function (100 ml for trough FEV1), dyspnea (improvement of ? 1 unit in the Transition Dyspnea Index total score or 5 units in the University of California, San Diego Shortness of Breath Questionnaire), health status (reduction of 4 units in the St George's Respiratory Questionnaire total score), and exercise capacity (47.5 m for the incremental shuttle walking test, 45-85 s for the endurance shuttle walking test, and 46-105 s for constant-load cycling endurance tests), but there is currently no validated MCID for exacerbations. In a clinical trial setting, many factors, including study duration, withdrawal rate, baseline severity, and Hawthorne effects, can influence the measured treatment effect and determine whether it reaches the MCID. We also address recent challenges presented by clinical trials that compare active treatments and suggest that MCIDs should be used to identify the additional proportion of patients who benefit, for example, when one drug is replaced by another or when a second drug is added to a first. We propose the term "minimum worthwhile incremental advantage" to describe this parameter. PMID:24383418

  16. Meta-analysis in clinical trials revisited.

    Science.gov (United States)

    DerSimonian, Rebecca; Laird, Nan

    2015-11-01

    In this paper, we revisit a 1986 article we published in this Journal, Meta-Analysis in Clinical Trials, where we introduced a random-effects model to summarize the evidence about treatment efficacy from a number of related clinical trials. Because of its simplicity and ease of implementation, our approach has been widely used (with more than 12,000 citations to date) and the "DerSimonian and Laird method" is now often referred to as the 'standard approach' or a 'popular' method for meta-analysis in medical and clinical research. The method is especially useful for providing an overall effect estimate and for characterizing the heterogeneity of effects across a series of studies. Here, we review the background that led to the original 1986 article, briefly describe the random-effects approach for meta-analysis, explore its use in various settings and trends over time and recommend a refinement to the method using a robust variance estimator for testing overall effect. We conclude with a discussion of repurposing the method for Big Data meta-analysis and Genome Wide Association Studies for studying the importance of genetic variants in complex diseases. PMID:26343745

  17. Bamboo as Soil Reinforcement: A Laboratory Trial

    Directory of Open Access Journals (Sweden)

    Alhaji Mohammed MUSTAPHA

    2008-12-01

    Full Text Available A lateritic soil classified as A-6 under AASHTO soil classification system was reinforced with 0, 1, 2 and 3 bamboo specimens at laboratory trial level to evaluate its unconfined compressive strength (UCS and modulus of rigidity. The soil specimens were molded in cylindrical form of 38mm diameter and 76mm height while the bamboo specimens were trimmed in to circular plates of 34mm diameter and 3mm thickness. The trial soil specimens are: soil specimen without bamboo specimen (0 bamboo, soil specimen with one bamboo specimen in the center (1 bamboo, soil specimen with one bamboo specimen on top and one at the bottom (2 bamboos and soil specimen with one bamboo specimen on top, center and bottom (3 bamboos. Though, the dry density of the molded soil specimen decreased from 1.638Mg/m3 at 0 bamboo to 1.470Mg/m2 at 3 bamboos, the UCS increased from 226KN/m2 at 0 bamboo to 621KN/m2 at 3 bamboos. Also, for each of the 3 percentage strains (0.5, 1.0 and 1.5% considered, the modulus of rigidity increased with bamboo specimens.

  18. Leucaena leucocephala trials in Uttar Pradesh (India)

    Energy Technology Data Exchange (ETDEWEB)

    Chaturvedi, A.N.

    1981-10-01

    Trials of high yielding Leucaena varieties imported from Hawaii and Australia, etc. are being carried out in Uttar Pradesh since 1976-1977. Two varieites of K-8 of Hawaiian and Fiji origin respectively were tried in hills. The Fiji variety exhibited poor growth but the Hawaiian variety has grown vigourously. The plants grow well only in deep moist soils and on dry soils manuring and irrigation for two years is required. It can grow upto 1300 metres elevation and is vulnerable to heavy damage by cattle, deer, monkeys, etc. The species grows well even in Lantana infested areas and started producing seeds within six months of planting. Trials of Leucaena varieties in Tarai region showed gummosis during March 1980. The infected tree stops growing and starts drying from the top and generally dies. The species is not considered suitable for planting in Tarai region under unirrigated conditions. It has, however, done very well in Clutterbuckganj Nursery at Bareilly in good soil and under irrigated condition. In acidic soils its growth has been observed to be poor but it has done very well on soil with pH of about 9. It can tolerate light shade but is not suitable for frosty areas or those with clayey soils. Pre-treatment with scarification, boiling in water, soaking in water for 24-48 hours has given about 85% germination. However Leucaena has also been observed to germinate freely from seed even without treatment and the ground floor in old plantations in carpeted with seedlings.

  19. Competency to stand trial among female inpatients.

    Science.gov (United States)

    Kois, Lauren; Pearson, Jessica; Chauhan, Preeti; Goni, Margaret; Saraydarian, Lisa

    2013-08-01

    Competency to stand trial evaluations are conducted by forensic mental health professionals to opine whether defendants possess the mental abilities to understand, appreciate, and reason in regard to their court proceedings. The majority of research on competency to stand trial evaluations has focused on males, with research on female defendants being relatively underexplored. Even less is known of diverse female samples referred for competency evaluation. In the current study, we sought to examine whether characteristics associated with competency among predominantly male samples translate to a racially, ethnically, and culturally diverse group of female defendants (N = 288, 85% non-White). Chi-square analyses revealed significant relationships between findings of incompetence and defendants' diagnosis of a psychotic disorder, active psychotic symptoms, medication noncompliance, nonparticipation in the evaluation, and nonfelony charges. Logistic regression analysis indicated that defendants who experienced active psychotic symptoms, did not participate in their evaluations, and were not compliant with their medication were most likely to be found incompetent. Notably, neither minority status nor age was a significant characteristic in predicting incompetence. These findings in particular differ from much of the literature and highlight the need to examine competency within a cross-cultural framework, as characteristics associated with competency opinions do not necessarily translate across demographic groups. PMID:23148467

  20. Phase 0 clinical trial- an overview

    Directory of Open Access Journals (Sweden)

    Aanchal Satija

    2011-07-01

    Full Text Available Drug discovery begins in the laboratory with target identification and validation followed by pre-clinical and clinical development. The entire process takes around 10 to 15 years. It is associated with high costs and a high rate of failure. The probability of a drug going beyond Phase I testing is quite low. The quest for discovering anti-cancer agents has shifted from non-specific chemotherapeutic agents to a specific molecular target-based approach. Drug development processes for various drugs need to be re-evaluated. Phase 0 clinical trials act as a novel tool to hasten and improve the drug development from laboratory to clinic. Phase 0 studies enable go versus no-go decisions for a new drug early in its development process. The administration of a single sub-therapeutic dose provides preliminary data on the pharmacokinetics of the drug. It helps in confirming whether the drug behaves in humans as was predicted by pre-clinical studies. Notwithstanding, Phase 0 clinical studies are associated with some disadvantages. This article describes about Phase 0- its rationale, conduct, potential benefits and limitations. Key Words: Drug development, phase 0, clinical trial

  1. [Facing the unreliability of clinical trials literature].

    Science.gov (United States)

    Jefferson, Tom

    2016-01-01

    Journal publications of randomized controlled trials ("literature") have so far formed the basis for evidence of the effects of pharmaceuticals and biologicals. In the last decade, progressively accumulating evidence has shown that literature is affected by reporting bias with evident implications for the reliability of any decision based on literature or its derivatives such as research synthesis. Another important factor is the growing body of evidence of the fragility of editorial quality control mechanisms in biomedicine ande their easy exploitation for marketing purposes in the symbiosis between publishing and the pharmaceutical industry. Regulatory documents are probably more reliable than currently accessible other sources but there are many severe limitations to the long-term use of regulatory documents for research synthesis and decision-making. Instead of trying to reform the fields of research, industry, government, regulation and publishing, I propose basing public health decisions and reimbursement of any important interventions on independent trials and studies following the model pioneered by the Mario Negri Institute of Pharmacological Research. PMID:26901365

  2. Fluoxetine for trichotillomania: an open clinical trial.

    Science.gov (United States)

    Koran, L M; Ringold, A; Hewlett, W

    1992-01-01

    Of 17 adult patients with long-standing trichotillomania, 13 completed an 8- to 12-week open trial of fluoxetine, up to 80 mg per day. No patient had obsessive-compulsive disorder or major depression. We used the compulsions subscale of the Yale-Brown Obsessive-Compulsive Scale (YBOCS) to rate patients' hair-pulling behavior. The 13 completing patients' mean YBOCS score decreased significantly from 10.15 at baseline to 5.92 at the completion visit (Student's paired t = 4.82, df = 12, two-tailed p less than .001). Of these 13 patients, 5 experienced a 50 percent or greater decrease in their pulling behavior as measured by the YBOCS; 4 experienced between a 25 percent and 50 percent decrease. Three of the patients stopped pulling entirely, as did 2 of the 4 noncompleting patients. Three noncompleting patients discontinued treatment because of side effects, and 1 insisted on early use of behavior therapy. Comparative treatment trials elucidating the indications, risks, and expectable benefits of psychotherapeutic and pharmacological treatments are needed. PMID:1513916

  3. The Role of Tax Administration Lawyers in Criminal Trials

    OpenAIRE

    Péclat, Mélanie

    2013-01-01

    Criminal trials for tax evasion and VAT frauds Criminal trials for tax evasion clearly differ from standard trials. The Public prosecutor is not free to prosecute unless the ministry of Finance takes legal action. The complaint lodged by the ministry of Finances is filtered by the Commission on Fiscal Offences (Commission des infractions fiscales CIF), which decides which cases require criminal prosecution. Only a minority of the tax evasion cases handled by the tax administration are prosecu...

  4. European randomized lung cancer screening trials : Post NLST

    DEFF Research Database (Denmark)

    Field, John K; van Klaveren, Rob

    2013-01-01

    Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects of their trials at August 2010, which included 32,000 people, inclusion of UKLS pilot trial will reach 36,000. An interim analysis is planned, but the final mortality data testing is scheduled for 2015.

  5. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida; Tendal, Britta; Hilden, Jørgen; Boutron, Isabelle; Ravaud, Philippe; Brorson, Stig

    2013-01-01

    BACKGROUND: Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS: We conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central ...

  6. Patient representatives’ views on patient information in clinical cancer trials

    OpenAIRE

    Dellson, Pia; Nilbert, Mef; Carlsson, Christina

    2016-01-01

    Background Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives’ views and perceptions on the written trial information used in clinical cancer trials. Methods Written patient information leaflet...

  7. Registration of Clinical Trials: Is it Really Needed?

    OpenAIRE

    Aslam, Ameer; Imanullah, Sameera; Asim, Mohammad; El-Menyar, Ayman

    2013-01-01

    Background and Aims: Withholding findings of clinical trials for publication or presentation to the regulatory authorities is a major concern. We aimed to address the importance of clinical trial registration and whether it is needed or not. Discussion: For ethical conduct of clinical trial, registration is an important but debatable issue due to proprietary interest of the pharmaceutical industry. Over the years, investigating agencies uncovered several instances of misconduct during the cli...

  8. A surplus of positive trials: weighing biases and reconsidering equipoise

    OpenAIRE

    Felson, David T.; Glantz, Leonard

    2004-01-01

    In this issue, Fries and Krishnan raise provocative new ideas to explain the surfeit of positive industry sponsored trials evaluating new drugs. They suggest that these trials were designed after so much preliminary work that they were bound to be positive (design bias) and that this violates clinical equipoise, which they characterize as an antiquated concept that should be replaced by a focus on subject autonomy in decision making and expected value for all treatments in a trial. We contend...

  9. An Internet-Based Cancer Clinical Trials Matching Resource

    OpenAIRE

    Metz, James M; Coyle, Carolyn; Hudson, Courtney; Hampshire, Margaret

    2005-01-01

    Background Many patients are now accessing the Internet to obtain cancer clinical trials information. However, services offering clinical trials recruitment information have not been well defined. Objectives This study describes one of the first Web-based cancer clinical trials matching resources and the demographics of users who were successfully matched. Methods OncoLink is the Internet-based educational resource managed by the University of Pennsylvania Cancer Center (UPCC) and serves betw...

  10. Data retention after a patient withdraws consent in clinical trials

    OpenAIRE

    Gabriel A; Mercado CP

    2011-01-01

    André P Gabriel, Charles P MercadoDepartment of Medicine, Columbia University Medical Center, New York, NY, USAAbstract: Patient retention is critically important in the conduct of a successful clinical trial. The power in numbers in multicenter trials is dependent on the completion of follow-up for every patient randomized. If at the end of a clinical trial, a significant number of randomized patients are missing outcome data, there will not be enough pool for data analyses to con...

  11. Application of remote sensing to agricultural field trials.

    OpenAIRE

    Clevers, J. G. P. W.

    1993-01-01

    Remote sensing techniques enable quantitative information about a field trial to be obtained instantaneously and non-destructively. The aim of this study was to identify a method that can reduce inaccuracies in field trial analysis, and to identify how remote sensing can support and/or replace conventional field measurements in field trials.In the literature there is a certain consensus that the best bands from which characteristic spectral information about vegetation can be extracted are th...

  12. The Columbia Registry of Controlled Clinical Computer Trials.

    OpenAIRE

    Balas, E. A.; MITCHELL, J A; Bopp, K.; Brown, G. D.; Ewigman, B. T.

    1992-01-01

    Numerous reports on randomized controlled clinical trials of computer-based interventions have been published. These trials provide useful evaluations of the impact of information technology on patient care. Unfortunately, several obstacles make access to the trial reports difficult. Barriers include the large variety of publications in which reports may appear, non-standard descriptors, and incomplete indexing. Some analyzers indicate inadequate testing of computer methods. The purpose of es...

  13. Drug safety assessment in clinical trials: methodological challenges and opportunities

    OpenAIRE

    Singh Sonal; Loke Yoon K

    2012-01-01

    Abstract Randomized controlled trials are the principal means of establishing the efficacy of drugs. However pre-marketing trials are limited in size and duration and exclude high-risk populations. They have limited statistical power to detect rare but potentially serious adverse events in real-world patients. We summarize the principal methodological challenges in the reporting, analysis and interpretation of safety data in clinical trials using recent examples from systematic reviews. These...

  14. Evaluation of Patient Enrollment in Oncology Phase I Clinical Trials

    OpenAIRE

    Biessen, D.; Cranendonk, Merlijn; Schiavon, Gaia; van der Holt, Bronno; Wiemer, Erik; Eskens, Ferry; Verweij, Jaap; de Jonge, Maja; Mathijssen, Ron

    2013-01-01

    Introduction. For anticancer drug development, it is crucial that patients participate in early-phase clinical trials. The main aim of this study was to gain insight into the motivations and other variables influencing patients in their decision to participate in phase I oncology trials. Materials and Methods. Over a period of 25 months, all patients who were informed about (specific) phase I trials in our cancer center were retrospectively included in this study. Data on providing informed c...

  15. A Brief History of Placebos and Clinical Trials in Psychiatry

    OpenAIRE

    SHORTER, EDWARD

    2011-01-01

    The history of placebos in psychiatry can be understood only in the context of randomized controlled trials (RCTs). Placebo treatments are as old as medicine itself, and are particularly effective in dealing with psychosomatic symptoms. In psychiatry, placebos have mainly been featured in clinical drug trials. The earliest controlled trial in psychiatry (not involving drugs) occurred in 1922, followed by the first crossover studies during the 1930s. Meanwhile the concept of randomization was ...

  16. ADAPT: The Wrong Way to Stop a Clinical Trial

    OpenAIRE

    . .

    2006-01-01

    Editorial Commentary Background: Evidence from observational studies suggests that people taking certain nonsteroidal anti-inflammatory drugs (NSAIDs) are at lower risk of developing Alzheimer's disease. However, in order to reliably find out whether NSAIDs reduce the risk of Alzheimer's, it is important to perform a properly designed randomized trial. Such a trial, ADAPT, was sponsored by the United States National Institute on Aging, and the study started recruitment in 2001. The trial invo...

  17. Long-term visual search: Examining trial-by-trial learning over extended visual search experiences.

    Science.gov (United States)

    Ericson, Justin; Biggs, Adam; Winkle, Jonathan; Gancayco, Christina; Mitroff, Stephen

    2015-09-01

    Airport security personnel search for a large number of prohibited items that vary in size, shape, color, category-membership, and more. This highly varied search set creates challenges for search accuracy, including how searchers are trained in identifying a myriad of potential targets. This challenge has both practical and theoretical implications (i.e., determining how best to obtain high accuracy, and how large memory sets interact with visual search performance, respectively). Recent research on "hybrid visual and memory search" (e.g., Wolfe, 2012) has begun to address such issues, but many questions remain. The current study addressed a difficult problem for traditional laboratory-based research-how does trial-by-trial learning develop over time for a large number of target types? This issue, which we call "long-term visual search," is key for understanding how reoccurring information in retained in memory so that it can aid future searches. Through the use of "big data" from the mobile application Airport Scanner (Kedlin Co.), it is possible to address such previously intractable questions. Airport Scanner is a game where players serve as an airport security officers looking for prohibited items in simulated bags. The game has over 7 million downloads and provides a powerful tool for psychological research (Mitroff et al., 2014 JEP:HPP). Trial-by-trial learning for multiple different targets was addressed by analyzing data from 50,000 participants. Distinct learning curves for each specific target revealed that accuracy rises asymptotically across trials without deteriorating to initially low starting levels. Additionally, an investigation into the number of to-be-searched-for target items indicated that performance accuracy remained high even as the memorized set size increased. The results suggest that items stored in memory generate their own item-specific template that is reinforced from repeated exposures. These findings offer insight into how novices develop into experts at target detection over the course of training. Meeting abstract presented at VSS 2015. PMID:26326796

  18. Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials

    Science.gov (United States)

    Ferreira-González, Ignacio; Permanyer-Miralda, Gaiet; Domingo-Salvany, Antònia; Heels-Ansdell, Diane; Montori, Victor M; Akl, Elie A; Bryant, Dianne M; Alonso-Coello, Pablo; Alonso, Jordi; Worster, Andrew; Upadhye, Suneel; Jaeschke, Roman; Schünemann, Holger J; Pacheco-Huergo, Valeria; Wu, Ping; Mills, Edward J; Guyatt, Gordon H

    2007-01-01

    Objective To explore the extent to which components of composite end points in randomised controlled trials vary in importance to patients, the frequency of events in the more and less important components, and the extent of variability in the relative risk reductions across components. Design Systematic review of randomised controlled trials. Data sources Cardiovascular randomised controlled trials published in the Lancet, Annals of Internal Medicine, Circulation, European Heart Journal, JAMA, and New England Journal of Medicine, from 1 January 2002 to 30 June 2003. Component end points of composite end points were categorised according to importance to patients as fatal, critical, major, moderate, or minor. Results Of 114 identified randomised controlled trials that included a composite end point of importance to patients, 68% (n=77) reported complete component data for the primary composite end point; almost all (98%; n=112) primary composite end points included a fatal end point. Of 84 composite end points for which component data were available, 54% (n=45) showed large or moderate gradients in both importance to patients and magnitude of effect across components. When analysed by categories of importance to patients, the most important components were associated with lower event rates in the control group (medians of 3.3-3.7% for fatal, critical, and major outcomes; 12.3% for moderate outcomes; and 8.0% for minor outcomes). Components of greater importance to patients were associated with smaller treatment effects than less important ones (relative risk reduction of 8% for death and 33% for components of minor importance to patients). Conclusion The use of composite end points in cardiovascular trials is frequently complicated by large gradients in importance to patients and in magnitude of the effect of treatment across component end points. Higher event rates and larger treatment effects associated with less important components may result in misleading impressions of the impact of treatment. PMID:17403713

  19. Credentialing institutions for advanced technology clinical trials

    International Nuclear Information System (INIS)

    The Radiological Physics Center (RPC) is responsible for credentialing institutions to use advanced technologies in radiation therapy clinical trials sponsored by the US National Cancer Institute (NCI). The RPC was founded in 1968 and has functioned continuously for 42 years to support NCI-sponsored clinical trials. The focus of this presentation is on the RPC's evaluation of advanced technology radiation therapy. The use of the RPC's benchmarks and anthropomorphic phantoms has revealed a number of interesting observations about the delivery of IMRT and SBRT, some of which have caught the attention of the public and the news media. Medical physicists should be aware of, and understand these results. At institutions that participate in NCI-sponsored clinical trials, the RPC monitors the basic machine output and brachytherapy source strengths, the dosimetry data utilized by the institutions, the calculation algorithms used for treatment planning, and the institutions' quality control procedures. The methods of monitoring include on-site dosimetry review by an RPC physicist, and a variety of remote audit tools. During the on-site evaluation, the institution's physicists and radiation oncologists are interviewed, physical measurements are made on the therapy machines, dosimetry and quality assurance data are reviewed, and patient dose calculations are evaluated. The remote audit tools include 1) mailed dosimeters evaluated on a periodic basis to verify output calibration and simple questionnaires to document changes in personnel, equipment, and dosimetry practices, 2) comparison of dosimetry data with RPC ''standard'' data to verify the compatibility of dosimetry data, 3) evaluation of reference and actual patient calculations to verify the validity of treatment planning algorithms, and 4) review of the institution's written quality assurance procedures and records. Mailable anthropomorphic phantoms are also used to verify tumor dose delivery for special treatment techniques. Any discrepancies identified by the RPC are pursued to help the institution find the origin of the discrepancies and identify and implement methods to resolve them. The RPC has recently extended all of the monitoring and credentialing programs to include proton beam facilities. Institutions are required to irradiate an anthropomorphic phantom to participate in certain clinical trials that involve advanced technologies such as IMRT and SBRT. The institution must handle the phantom as if it were a patient; they perform a CT simulation, develop a treatment plan, and then deliver the treatment according to their plan. The phantom is returned to the RPC where the dosimeters are removed and analyzed. The treatment plan must be submitted electronically to the Image-Guided Therapy QA Center (ITC), a QA center that participates with the RPC to handle digital data. The RPC then compares the institution's treatment plan with the results of the dosimeter analysis. Criteria for agreement vary with phantom model, but for several phantoms are 7% dose and 4 mm distance to agreement. The RPC has reported on several occasions that the failure rate with the anthropomorphic phantoms ranges between 20% and 30%. This large failure rate has been commented upon by the American Association of Physicists in Medicine (AAPM) and other organizations, and a topic of concern for several of the clinical trials study groups

  20. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida; Tendal, Britta; Hilden, Jørgen; Boutron, Isabelle; Ravaud, Philippe; Brorson, Stig

    2013-01-01

    BACKGROUND: Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS: We......%). Heterogeneity was moderate (I(2) = 46%, p = 0.02) and unexplained by metaregression. INTERPRETATION: We provide empirical evidence for observer bias in randomized clinical trials with subjective measurement scale outcomes. A failure to blind assessors of outcomes in such trials results in a high risk of...... substantial bias....

  1. Statistical considerations for a trial of Ebola virus disease therapeutics.

    Science.gov (United States)

    Proschan, Michael A; Dodd, Lori E; Price, Dionne

    2016-02-01

    The 2014 West African outbreak of Ebola virus ravaged Liberia, Sierra Leone, and Guinea, causing hemorrhagic fever and death. The need to identify effective therapeutics was acute. The usual drug development paradigm of phase I, followed by phase II, and then phase III trials would take too long. These and other factors led to the design of a clinical trial of Ebola virus disease therapeutics that differs from more conventional clinical trial designs. This article describes the Ebola virus disease medical countermeasures trial design and the thinking behind it. PMID:26768567

  2. Sample sizes in dosage investigational clinical trials: a systematic evaluation

    OpenAIRE

    Huang, Ji-Han; Su, Qian-Min; Yang, Juan; Lv, Ying-Hua; He, Ying-Chun; Chen, Jun-Chao; Xu, Ling; Wang, Kun; Zheng, Qing-shan

    2015-01-01

    The main purpose of investigational phase II clinical trials is to explore indications and effective doses. However, as yet, there is no clear rule and no related published literature about the precise suitable sample sizes to be used in phase II clinical trials. To explore this, we searched for clinical trials in the ClinicalTrials.gov registry using the keywords “dose-finding” or “dose–response” and “Phase II”. The time span of the search was September 20, 1999, to December 31, 2013. A tota...

  3. Stopping trials early for benefit--not so fast!

    Science.gov (United States)

    Faust, Andrew C; Chung, Tammy; Feldman, Mark

    2012-11-01

    On October 25, 2011, Eli Lilly and Company announced the voluntary withdrawal of Xigris (drotrecogin alfa [activated]) following the negative results of its most recent clinical trial, the PROWESS-SHOCK study. The purpose of this commentary is to briefly review the history of drotrecogin alfa, discuss issues surrounding early cessation of clinical trials for benefit, and highlight the scientific and ethical dilemmas faced when deciding whether or not to stop a trial early for benefit. This review should serve as an introduction to the topic of stopping trials early for benefit. PMID:23136354

  4. A review of prospective Clinical Trials for neurogenic bladder: Pharmaceuticals

    Science.gov (United States)

    Braschi, Emmanuel; Lavelle, John

    2014-01-01

    Introduction The neurogenic urinary bladder is defined as a dysfunctional bladder associated with a known neurological injury. We review the data from good quality clinical trials looking at drug therapy for the neurogenic bladder. Materials and methods In order to identify as many prospective trials as possible, we performed Internet searches, using the same search string: Urinary Bladder, neurogenic (MESH). In each case, the search was limited to clinical trial, prospective trial, subjects were human and the language was English. There was no year limit for our search. The next step was duplicate removal, which led to a final number of 580 papers. We defined clear inclusion criteria for the papers. Results A total of 82 full text papers were reviewed and analyzed according to the previously mentioned algorithm. The oldest two prospective clinical trials date back to 1976, with an obvious increase in number of trials each year, reaching more than five trials per year after 2001, which demonstrates increased interest toward the subject. The total number of patients included in the trials is 3904, 888 of which are children. The male: female ratio is close to 1, although there were 9 studies where no information regarding the sex of the patients was available. Conclusions Our analysis stresses the acute need for good quality trials looking at the drugs used for the management of the patients with neurogenic bladders, with adequate statistical power to support the data they present. PMID:25247085

  5. New developments in the conduct and management of multi-center trials : an international review of clinical trial units

    DEFF Research Database (Denmark)

    Gluud, C; SØrensen, T I

    1995-01-01

    There is an urgent need for the performance of more, better designed, and better managed randomized clinical trials. After visits to 43 leading organizations and units involved in clinical trials in Europe and North America during 1993, the way of conducting randomized clinical trials was analyzed. By using a structured questionnaire, information on recent improvements in the way randomized clinical trials are performed was identified. These developments encompass human aspects (better information, collaboration, and communication) as well as non-human aspects (press button phone randomization and data management systems). By employing such developments, randomized clinical trials can run much more efficiently. This facilitates faster and better answers to the questions addressed by randomized clinical trials, thereby also making them more ethical.

  6. Phase I (first-in-man prophylactic vaccine?s clinical trials: Selecting a clinical trial site

    Directory of Open Access Journals (Sweden)

    Shantanu Mehta

    2015-01-01

    Full Text Available An appropriately equipped and staffed Phase I unit is critical for smooth conduct of a first-in-man clinical trial. The first-in-man prophylactic vaccine trial(s requires basic infrastructure of clinical trial site, experienced and dedicated site staff and healthy adults as volunteers. The facility should have access to equipment, emergency services, laboratory, pharmacy and archiving.In terms of design, infrastructure, workflow and manpower, a Phase I unit for testing a novel vaccine or drug are quite similar. However, there are some important attributes, which should be taken into consideration, while performing pre-trial site selection for conducting phase I trial with a new or novel vaccine.

  7. The challenges and opportunities of conducting a clinical trial in a low resource setting: The case of the Cameroon mobile phone SMS (CAMPS trial, an investigator initiated trial

    Directory of Open Access Journals (Sweden)

    Ongolo-Zogo Pierre

    2011-06-01

    Full Text Available Abstract Conducting clinical trials in developing countries often presents significant ethical, organisational, cultural and infrastructural challenges to researchers, pharmaceutical companies, sponsors and regulatory bodies. Globally, these regions are under-represented in research, yet this population stands to gain more from research in these settings as the burdens on health are greater than those in developed resourceful countries. However, developing countries also offer an attractive setting for clinical trials because they often have larger treatment naive populations with higher incidence rates of disease and more advanced stages. These factors can present a reduction in costs and time required to recruit patients. So, balance needs to be found where research can be encouraged and supported in order to bring maximum public health benefits to these communities. The difficulties with such trials arise from problems with obtaining valid informed consent, ethical compensation mechanisms for extremely poor populations, poor health infrastructure and considerable socio-economic and cultural divides. Ethical concerns with trials in developing countries have received attention, even though many other non-ethical issues may arise. Local investigator initiated trials also face a variety of difficulties that have not been adequately reported in literature. This paper uses the example of the Cameroon Mobile Phone SMS trial to describe in detail, the specific difficulties encountered in an investigator-initiated trial in a developing country. It highlights administrative, ethical, financial and staff related issues, proposes solutions and gives a list of additional documentation to ease the organisational process.

  8. A trial on unruptured intracranial aneurysms (the TEAM trial: results, lessons from a failure and the necessity for clinical care trials

    Directory of Open Access Journals (Sweden)

    Molyneux Andrew J

    2011-03-01

    Full Text Available Abstract The trial on endovascular management of unruptured intracranial aneurysms (TEAM, a prospective randomized trial comparing coiling and conservative management, initiated in September 2006, was stopped in June 2009 because of poor recruitment (80 patients. Aspects of the trial design that may have contributed to this failure are reviewed in the hope of identifying better ways to successfully complete this special type of pragmatic trial which seeks to test two strategies that are in routine clinical use. Cultural, conceptual and bureaucratic hurdles and difficulties obstruct all trials. These obstacles are however particularly misplaced when the trial aims to identify what a good medical practice should be. A clean separation between research and practice, with diverging ethical and scientific requirements, has been enforced for decades, but it cannot work when care needs to be provided in the presence of pervasive uncertainty. Hence valid and robust scientific methods need to be legitimately re-integrated into clinical practice when reliable knowledge is in want. A special status should be reserved for what we would call 'clinical care trials', if we are to practice in a transparent and prospective fashion a medicine that leads to demonstrably better patient outcomes.

  9. Homeopathic pathogenetic trial of Plumbum metallicum: the complete 2000 trial with a synthesis of the original 1828 trial

    Directory of Open Access Journals (Sweden)

    Christa Pichler

    2011-03-01

    Full Text Available Background: in a previous paper we reported the statistical analysis and other distribution data of a homeopathic pathogenetic trial (HPT of Plumbum metallicum 30cH carried out by our group. However, at that time we did not report the resulting pure materia medica, i.e., the totality of symptoms elicited by the tested medicine on healthy volunteers. Aim: to communicate to the homeopathic community the full record of symptoms collected in our HPT of Plb. Methods: methods to collect and select symptoms have been reported in the previous paper. In synthesis were excluded all previous common symptoms of volunteers, even with slight differences, and selected only those that were really unknown, never seen, unusual or very strange for the prover. In this paper special emphasis was given to new symptoms as well as unusual or repeated dreams, while in the previous paper special emphasis was given to repeated and crossed symptoms. Results: symptoms are reported in their chronological order of appearance in each volunteer. 37 new symptoms were found, useful to update Homeopathic Repertories. It is also included a synthesis of the original HPT of Plb carried out in 1828 in order to make available the full experimental materia medica currently existing. Conclusions: the new HPT, besides widening the pathogenetic picture of Plb (skin and mucosae symptoms, also allowed us to give new and deeper meanings to some of the symptoms reported in the original trial, such as Anxiety, Activity, Depression, Slowness, Gastro-oesophageal problems, Colitis. The dreams complete the remedy image, mainly in work, religion and sexual themes. Up to the present time there is no peer-reviewed publication devoted to HPTs. For this reason, researchers are compelled to publish HPTs as private editions. This results in poor control of the quality of publications and a lack of standards on how to present the results of HPTs.

  10. A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: Trial protocol

    OpenAIRE

    Cox, Helen; Tilbrook, Helen; Aplin, John; Chuang, Ling-Hsiang; Hewitt, Catherine; Jayakody, Shalmini; Semlyen, Anna; Soares, Marta O; Torgerson, David; Trewhela, Alison; Watt, Ian; Worthy, Gill

    2010-01-01

    A systematic review revealed three small randomised controlled trials of yoga for low back pain, all of which showed effects on back pain that favoured the yoga group. To build on these studies a larger trial, with longer term follow-up, and a number of different yoga teachers delivering the intervention is required. This study protocol describes the details of a randomised controlled trial (RCT) to determine the effectiveness and cost-effectiveness of Yoga for chronic Low Back Pain, which is...

  11. Randomised trials of STD treatment for HIV prevention: report of an international workshop. HIV/STD Trials Workshop Group.

    OpenAIRE

    Hayes, R.; Wawer, M; Gray, R.; Whitworth, J.; Grosskurth, H; MABEY, D.

    1997-01-01

    Three community trials of the impact of STD treatment interventions on HIV incidence in rural populations have been completed or are in progress in Uganda and Tanzania. Investigators from these trials met for a joint technical workshop in Baltimore in May 1996. This report summarises the consensus of the workshop, with the aim of providing useful input to research on HIV intervention strategies. Issues discussed include: (i) the role of community randomised trials; (ii) strategies for STD man...

  12. The “House Calls” Trial: A Randomized Controlled Trial to Reduce Racial Disparities in Live Donor Kidney Transplantation: Rationale and Design

    OpenAIRE

    Rodrigue, James R.; Pavlakis, Martha; Egbuna, Ogo; Paek, Mathew; Waterman, Amy D; Mandelbrot, Didier A.

    2012-01-01

    Despite a substantially lower rate of live donor kidney transplantation among Black Americans compared to White Americans, there are few systematic efforts to reduce this racial disparity. This paper describes the rationale and design of a randomized controlled trial aims evaluating the comparative effectiveness of three different educational interventions for increasing live donor kidney transplantation in Black Americans. This trial is a single-site, urn-randomized controlled trial with a p...

  13. DeLLITE Depression in late life: an intervention trial of exercise. Design and recruitment of a randomised controlled trial

    OpenAIRE

    Keeling Sally; Peri Kathy; Hatcher Simon; Elley C Raina; Dowell Tony; Kolt Gregory S; Hayman Karen J; Moyes Simon A; Falloon Karen; Kerse Ngaire; Robinson Elizabeth; Parsons John; Wiles Janine; Arroll Bruce

    2008-01-01

    Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE) is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years a...

  14. Improving the quality of randomized controlled trials in Chinese herbal medicine, Part ?: clinical trial design and methodology

    Directory of Open Access Journals (Sweden)

    Zhao-Xiang BIAN

    2006-03-01

    Full Text Available Objective: To discuss the quality of randomized controlled trials (RCTs in Chinese herbal medicine (CHM with respect to design and methodology, and provide suggestions for further improvement in future clinical trials. Methods: A search of the Cochrane Library was conducted to identify RCTs of CHM on line in July 2005. Quality of the RCTs was assessed using a 11-item checklist modified from the revised CONSORT statement, with 2 items specific to CHM (i.e. herb preparation form and quality control of herbs. Results: The search yielded 167 RCTs that were selected for assessment. All trials included statements about the interventions, objectives, primary outcome design, statistical methods, and herb preparation form. Although 163 (97.6% trials reported inclusion criteria, exclusion criteria were only reported in 26 (15.6% trials. Fewer than 10% of trials clearly stated the random allocation sequence generation methods, and only 2.4% mentioned allocation concealment. The vast majority (86.8% of trials were open-label, while only 13.2% used blinding. Almost half (45.5% administered the CHM intervention as a tea or decoction. Only one trial (0.6% reported a sample size calculation, and a single trial (0.6% discussed quality control of the CHM intervention. Conclusion: The overall methodologic quality of RCTs in CHM was poor. It is essential to improve the design of future RCTs in this clinical area. Recommendations: (1 Investigator conducting RCTs should have formal training about clinical trial design; (2 A flow chart is recommended to ensure that all essential steps of clinical trial design are included. (3 Conducting pilot studies prior to RCTs may help improve their design; (4 Registration of clinical trials and publishing their protocols prior to enrolment may reduce publication bias and solicit peer reviews of the proposed design; (5 Collaboration between CHM investigators and traditional medicine academic research centers interested in integrative medicine may lead to quality improvement of RCTs of CHM.

  15. Impact of Cyclooxygenase Inhibitors in the Women's Health Initiative Hormone Trials: Secondary Analysis of a Randomized Trial

    OpenAIRE

    HSIA, JUDITH; Kuller, Lewis; Pettinger, Mary; Choe, John H.; Limacher, Marian; Oberman, Albert; Ockene, Judith; O'Sullivan, Mary Jo; Jennifer G Robinson; Manson, JoAnn Elisabeth; LANGER, Robert D

    2006-01-01

    Objectives: We evaluated the hypothesis that cyclooxygenase (COX) inhibitor use might have counteracted a beneficial effect of postmenopausal hormone therapy, and account for the absence of cardioprotection in the Women's Health Initiative hormone trials. Estrogen increases COX expression, and inhibitors of COX such as nonsteroidal anti-inflammatory agents appear to increase coronary risk, raising the possibility of a clinically important interaction in the trials. Design: The hormone trials ...

  16. Can we improve the statistical analysis of stroke trials? Statistical re-analysis of functional outcomes in stroke trials

    OpenAIRE

    Bath, Philip

    2007-01-01

    Background Most large acute stroke trials have been neutral. Functional outcome is usually analysed using a yes or no answer, e.g. death or dependency vs. independence. We assessed which statistical approaches are most efficient in analysing outcomes from stroke trials. Methods Individual patient data from acute, rehabilitation and stroke unit trials studying the effects of interventions which alter functional outcome were assessed. Outcomes included modified Rankin Scale, Bar...

  17. Escritas de luz: Der Prozess/ The Trial

    Directory of Open Access Journals (Sweden)

    Michael Löwy

    2015-02-01

    Full Text Available ResumoLiteratura e cinema constituem duas linguagens distintas, irredutíveis. Suas gramáticas, léxicos e sintaxes são radicalmente diferentes. Toda imagem, e a fortiori toda sucessão de imagens, é necessariamente, inevitavelmente, “infiel”ao texto. No seu filme The trial, Orson Welles apropriou-se do romance de Kafka — O processo — para recriá-lo nos seus próprios termos. O romance não exprime uma mensagem política ou doutrinária; mas, sobretudo, um certo estado de espírito antiautoritário. Reencontramos, sob uma outra forma,e com outros meios estéticos, esse mesmo estado de espírito no filme.AbstractLiterature and cinema are two distinct and irreducible languages. Their grammar, vocabulary and syntax are radically different. All image, and more so any succession ofimages is necessarily, inevitably, “unfaithful” to the text. Inhis movie The trial Orson Welles took possession of Kafka’s novel Der Prozess and re-created it in his own terms. The novel does not express a political or doctrinaire message, but rather a certain anti-authoritarian state of mind. One finds, in a different form, and with other aesthetic means, the samestate of mind in the movie.ResuméeLittérature et cinéma constituent deux langages distincts, irréductibles. Leur grammaire, leur lexique, leur syntaxe sont radicalement différents. Toute image, et à fortiori toute succession d’images est nécessairement,  inévitablement, “ infidèle ” au texte. Dans son film The trial Orson Welles s’est approprié du roman de Kafka — Le procès — pour le récréer dans ses propres termes. Le roman n’exprime pas un message politique ou doctrinaire, mais plutôt un certain état d’esprit anti-autoritaire. On retrouve, sous une autreforme, et avec d’autres moyens esthétiques, ce même état d’esprit dans le film.Michael Löwy é um sociólogo nascido no Brasil, formado em Ciências Sociais na Universidade de São Paulo e radicado na França. Diretor emérito de pesquisas do Centre National de la Recherche Scientifique (CNRS, foi homenageado com a medalha de prata do CNRS em Ciências Sociais no ano de 1994. É autor de Walter Benjamin: aviso de incêndio (2005, Franz Kafka: sonhador insubmisso (2005, Lucien Goldmann ou a dialética da totalidade (2009, A teoria da revolução no jovem Marx (2012 e organizador de Revoluções (2009 e Capitalismo como religião (2013, de Walter Benjamin.

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

    DEFF Research Database (Denmark)

    Sever, Peter S; Poulter, Neil R; Dahlof, Bjorn; Wedel, Hans; Beevers, Gareth; Caulfield, Mark; Collins, Rory; Kjeldsen, Sverre E; Kristinsson, Arni; McInnes, Gordon; Mehlsen, Jesper; Nieminen, Markku S; O'Brien, Eoin T; Ostergren, Jan

    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...

  19. Individual nutrition therapy and exercise regime: A controlled trial of injured, vulnerable elderly (INTERACTIVE trial

    Directory of Open Access Journals (Sweden)

    Whitehead Craig

    2008-02-01

    Full Text Available Abstract Background Proximal femoral fractures are amongst the most devastating consequences of osteoporosis and injurious accidental falls with 25–35% of patients dying in the first year post-fracture. Effective rehabilitation strategies are evolving however, despite established associations between nutrition, mobility, strength and strength-related functional outcomes; there has been only one small study with older adults immediately following fragility fracture where a combination of both exercise and nutrition have been provided. The aim of the INTERACTIVE trial is to establish whether a six month, individualised exercise and nutrition program commencing within fourteen days of surgery for proximal femur fracture, results in clinically and statistically significant improvements in physical function, body composition and quality of life at an acceptable level of cost and resource use and without increasing the burden of caregivers. Methods and Design This randomised controlled trial will be performed across two sites, a 500 bed acute hospital in Adelaide, South Australia and a 250 bed acute hospital in Sydney, New South Wales. Four hundred and sixty community-dwelling older adults aged > 70 will be recruited after suffering a proximal femoral fracture and followed into the community over a 12-month period. Participants allocated to the intervention group will receive a six month individualised care plan combining resistance training and nutrition therapy commencing within 14 days post-surgery. Outcomes will be assessed by an individual masked to treatment allocation at six and 12 months. To determine differences between the groups at the primary end-point (six months, ANCOVA or logistic regression will be used with models adjusted according to potential confounders. Discussion The INTERACTIVE trial is among the first to combine nutrition and exercise therapy as an early intervention to address the serious consequence of rapid deconditioning and weight loss and subsequent ability to regain pre-morbid function in older patients post proximal femoral fracture. The results of this trial will guide the development of more effective rehabilitation programs, which may ultimately lead to reduced health care costs, and improvements in mobility, independence and quality of life for proximal femoral fracture sufferers. Trial registration Australian Clinical Trials Registry: ACTRN12607000017426.

  20. DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative Treatment. A MULTICENTER RANDOMISED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    van de Wall Bryan JM

    2010-08-01

    Full Text Available Abstract Background Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses. Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management. We, therefore, constructed a randomised clinical trial comparing these two treatment strategies. Methods/design The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management. Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used. The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years. Discussion Considering the high incidence and the multicenter design of this study, it may be assumed that the number of patients needed for this study (n = 214, may be gathered within one and a half year. Depending on the expertise and available equipment, we prefer to perform a laparoscopic resection on patients randomised for elective surgery. Should this be impossible, an open technique may be used as this also reflects the current situation. Trial Registration (Trial register number: NTR1478

  1. The CORONIS Trial. International study of caesarean section surgical techniques: a randomised fractional, factorial trial

    Directory of Open Access Journals (Sweden)

    2007-10-01

    Full Text Available Abstract Background Caesarean section is one of the most commonly performed operations on women throughout the world. Rates have increased in recent years – about 20–25% in many developed countries. Rates in other parts of the world vary widely. A variety of surgical techniques for all elements of the caesarean section operation are in use. Many have not yet been rigorously evaluated in randomised controlled trials, and it is not known whether any are associated with better outcomes for women and babies. Because huge numbers of women undergo caesarean section, even small differences in post-operative morbidity rates between techniques could translate into improved health for substantial numbers of women, and significant cost savings. Design CORONIS is a multicentre, fractional, factorial randomised controlled trial and will be conducted in centres in Argentina, Ghana, India, Kenya, Pakistan and Sudan. Women are eligible if they are undergoing their first or second caesarean section through a transverse abdominal incision. Five comparisons will be carried out in one trial, using a 2 × 2 × 2 × 2 × 2 fractional factorial design. This design has rarely been used, but is appropriate for the evaluation of several procedures which will be used together in clinical practice. The interventions are: • Blunt versus sharp abdominal entry • Exteriorisation of the uterus for repair versus intra-abdominal repair • Single versus double layer closure of the uterus • Closure versus non-closure of the peritoneum (pelvic and parietal • Chromic catgut versus Polyglactin-910 for uterine repair The primary outcome is death or maternal infectious morbidity (one or more of the following: antibiotic use for maternal febrile morbidity during postnatal hospital stay, antibiotic use for endometritis, wound infection or peritonitis or further operative procedures; or blood transfusion. The sample size required is 15,000 women in total; at least 7,586 women in each comparison. Discussion Improvements in health from optimising caesarean section techniques are likely to be more significant in developing countries, because the rates of postoperative morbidity in these countries tend to be higher. More women could therefore benefit from improvements in techniques. Trial registration The CORONIS Trial is registered in the Current Controlled Trials registry. ISCRTN31089967.

  2. Review of clinical trials for mitochondrial disorders: 1997-2012.

    Science.gov (United States)

    Kerr, Douglas S

    2013-04-01

    Over the last 15 years, some 16 open and controlled clinical trials for potential treatments of mitochondrial diseases have been reported or are in progress, and are summarized and reviewed herein. These include trials of administering dichloroacetate (an activator of pyruvate dehydrogenase complex), arginine or citrulline (precursors of nitric oxide), coenzyme Q10 (CoQ10; part of the electron transport chain and an antioxidant), idebenone (a synthetic analogue of CoQ10), EPI-743 (a novel oral potent 2-electron redox cycling agent), creatine (a precursor of phosphocreatine), combined administration (of creatine, ?-lipoate, and CoQ10), and exercise training (to increase muscle mitochondria). These trials have included patients with various mitochondrial disorders, a selected subcategory of mitochondrial disorders, or specific mitochondrial disorders (Leber hereditary optic neuropathy or mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes). The trial designs have varied from open-label/uncontrolled, open-label/controlled, or double-blind/placebo-controlled/crossover. Primary outcomes have ranged from single, clinically-relevant scores to multiple measures. Eight of these trials have been well-controlled, completed trials. Of these only 1 (treatment with creatine) showed a significant change in primary outcomes, but this was not reproduced in 2 subsequent trials with creatine with different patients. One trial (idebenone treatment of Leber hereditary optic neuropathy) did not show significant improvement in the primary outcome, but there was significant improvement in a subgroup of patients. Despite the paucity of benefits found so far, well-controlled clinical trials are essential building blocks in the continuing search for more effective treatment of mitochondrial disease, and current trials based on information gained from these prior experiences are in progress. Because of difficulties in recruiting sufficient mitochondrial disease patients and the relatively large expense of conducting such trials, advantageous strategies include crossover designs (where possible), multicenter collaboration, and the selection of very few, clinically relevant, primary outcomes. PMID:23361264

  3. Parabolic Trough Solar Collector Initial Trials

    Directory of Open Access Journals (Sweden)

    Ghalya Pikra

    2011-12-01

    Full Text Available This paper discusses initial trials of parabolic trough solar collector (PTSC in Bandung. PTSC model consists of concentrator, absorber and tracking system. Concentrator designs are made with 2m aperture width, 6m length and 0.75m focal distance. The design is equipped with an automatic tracking system which is driven using 12V and 24Watt DC motor with 0.0125rpm rotational speed. Absorber/receiver is designed with evacuated tube type, with 1 inch core diameter and tube made of AISI304 and coated with black oxide, the outer tube is borosilicate glass with a 70 mm diameter and 1.5 m length. Working fluid stored in single type of thermal storage tank, a single phase with 37.7 liter volume. PTSC model testing carried out for 2 hours and 10 minutes produces heat output and input of 11.5 kW and 0.64 kW respectively. 

  4. Drugs and clinical trials in neurodegenerative diseases

    Directory of Open Access Journals (Sweden)

    Paolo Stanzione

    2011-01-01

    Full Text Available Neurodegenerative diseases are disabling conditions continuously increasing due to aging of population. A disease modifying therapy that slows or stops disease progression is therefore a major unmet medical need. Unfortunately, research for effective treatments is hampered by lack of knowledge on the pathologic processes underpinning these diseases and of reliable biomarkers. Clinical trials are difficult, as they require large populations that need to be followed for very long periods to capture possible effects on disease progression. These difficulties produce frequent failures and waste of human and economic resources. Since research has to continue in this area, until comprehensive knowledge of basic pathologic processes is obtained, alternative study designs can be considered to identify disease modifiers and to reduce costs of clinical studies.

  5. News from the Library: Knovel trial period

    CERN Multimedia

    CERN Library

    2014-01-01

    Knovel is a Web-based database integrating technical information with analytical and search tools. It is specifically aimed at the engineering community, offering validated content derived from the most trusted sources.   Knovel combines the functionalities of an e-book platform and a search engine querying a plurality of online databases. These functionalities are complemented by analytical tools that permit the extraction and manipulation of data from e-book content. Knovelʼs tools - including its interactive tables and graphs - not only help users to find information hidden in complex graphs, equations and tables quickly, but also to analyse and manipulate data as easily as sorting a spreadsheet. Using either simple keywords or full Boolean queries, Knovel searches across different data sets to find the information engineers need, however deeply it may be buried. For more information please visit why.knovel.com and the corresponding Youtube channel. A trial period of Knovel for the whol...

  6. Field trials results of guided wave tomography

    International Nuclear Information System (INIS)

    Corrosion is one of the industries major issues regarding the integrity of assets. Guided wave travel time tomography is a method capable of providing an absolute wall thickness map. This method is currently making the transition from the laboratory to the field. For this purpose a dedicated data acquisition system and special purpose EMAT sensor rings have been developed. The system can be deployed for permanent monitoring and inspections. Field trials have been conducted on various pipes with different diameters, containing either liquid or gas. The main focus has been on pipe supports. The results demonstrate the successful operation of the technology in the field. Expected corrosion damage was clearly visible on the produced results enabling asset owner to make calculated decisions on the pipelines safety, maintenance and operations

  7. Field trials results of guided wave tomography

    Science.gov (United States)

    Volker, Arno; van Zon, Tim; van der Leden, Edwin

    2015-03-01

    Corrosion is one of the industries major issues regarding the integrity of assets. Guided wave travel time tomography is a method capable of providing an absolute wall thickness map. This method is currently making the transition from the laboratory to the field. For this purpose a dedicated data acquisition system and special purpose EMAT sensor rings have been developed. The system can be deployed for permanent monitoring and inspections. Field trials have been conducted on various pipes with different diameters, containing either liquid or gas. The main focus has been on pipe supports. The results demonstrate the successful operation of the technology in the field. Expected corrosion damage was clearly visible on the produced results enabling asset owner to make calculated decisions on the pipelines safety, maintenance and operations.

  8. Commentary: Pursuing justice in death penalty trials.

    Science.gov (United States)

    Watson, Clarence; Eth, Spencer; Leong, Gregory B

    2012-01-01

    The capital trial, by its nature, is fraught with emotionally disturbing elements that jurors must face when deciding the ultimate fate of a guilty defendant. A confluence of mitigating and aggravating factors influences a capital jury's decision to impose a sentence of death. The presence or absence of defendant remorse in these cases may make all the difference in whether a capital defendant's life is spared. This commentary examines the onerous emotional toll encountered by capital jurors in light of the findings of Corwin and colleagues regarding defendant remorse and juror's need for affect. The commentary also presents practical and ethics-related considerations that should be kept in mind when reflecting on their study. PMID:22396341

  9. Mechanical ventilation: lessons from the ARDSNet trial

    Directory of Open Access Journals (Sweden)

    Marco Ranieri V

    2000-08-01

    Full Text Available Abstract The acute respiratory distress syndrome (ARDS is an inflammatory disease of the lungs characterized clinically by bilateral pulmonary infiltrates, decreased pulmonary compliance and hypoxemia. Although supportive care for ARDS seems to have improved over the past few decades, few studies have shown that any treatment can decrease mortality for this deadly syndrome. In the 4 May 2000 issue of New England Journal of Medicine, the results of an NIH-sponsored trial were presented; they demonstrated that the use of a ventilatory strategy that minimizes ventilator-induced lung injury leads to a 22% decrease in mortality. The implications of this study with respect to clinical practice, further ARDS studies and clinical research in the critical care setting are discussed.

  10. Lessons learned from the Sunbelt Melanoma Trial.

    Science.gov (United States)

    McMasters, Kelly M; Noyes, R Dirk; Reintgen, Douglas S; Goydos, James S; Beitsch, Peter D; Davidson, B Scott; Sussman, Jeffrey J; Gershenwald, Jeffrey E; Ross, Merrick I

    2004-07-01

    The Sunbelt Melanoma Trial is an ongoing multicenter prospective randomized trial that involves 79 centers and over 3600 patients from across the United States and Canada. This is one of the first large randomized studies to incorporate molecular staging using reverse transcriptase polymerase chain reaction (RT-PCR). While the results related to the primary endpoints of the study are not yet available, several analyses have shed light on many aspects of sentinel lymph node (SLN) biopsy and melanoma prognostic factors. In particular, we have developed a practical definition of sentinel nodes based on the degree of radioactivity. We have established the low rate of postoperative complications associated with SLN biopsy as compared to complete lymph node dissection. We have identified factors that predict the presence of SLN metastases. In contrast, we have been unable to identify factors that indicate a low risk of non-sentinel node metastases in patients with a positive sentinel node, suggesting that completion lymphadenectomy is appropriate for such patients. We have further established the value of identifying interval or in-transit sentinel nodes, which can be the only site of nodal metastasis. We have evaluated the particular challenges associated with SLN biopsy of head and neck melanomas, have evaluated the patterns of early recurrence, and have identified an interesting correlation between increasing patient age and a number of prognostic factors. Future analyses will evaluate the benefit of early therapeutic lymphadenectomy and early institution of adjuvant interferon alfa-2b therapy, as well as the validity of molecular staging. PMID:15221928

  11. Gateways to Clinical Trials. June 2002.

    Science.gov (United States)

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

    2002-06-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abacavir sulfate, abarelix, abciximab, alicaforsen sodium, almotriptan, alteplase, amlodipine, amoxicillin trihydrate, amprenavir, argatroban monohydrate, aspirin, atorvastatin calcium, azathioprine; Baclofen, benidipine hydrochloride, benserazide, BMS-214662, bosentan, botulinum toxin type B; Candesartan cilexetil, carbamazepine, carbidopa, carboplatin, ceftriaxone sodium, celecoxib, cetirizine hydrochloride, clarithromycin, clavulanate potassium, clopidogrel hydrogensulfate, clozapine, CPI-1189, cyclophosphamide, cytarabine; Darbepoetin alfa, denileukin diftitox, dexamethasone, dipyridamole, droperidol, DW-166HC; Ebastine, efalizumab, efavirenz, eletriptan, enalapril maleate, enfuvirtide, enoxaparin sodium, enrasentan, entacapone, epoetin, eprosartan mesilate, etanercept, etoricoxib; Fenofibratefexofenadine hydrochloride, filgrastim, fludarabine phosphate, fluoxetine hydrochloride fluvoxamine maleate, frovatriptan, furosemide; Gabapentin, galantamine hydrobromide, gatifloxacin, gefitinib, ghrelin (human), glatiramer acetate; Haloperidol; Ibuprofen, ibuprofen, guaiacol ester, idarubicin hydrochloride, imipramine hydrochloride, imiquimod, interferon beta, interferon beta-1a, interferon beta-1b, interferon omega, irbesartan, itraconazole; Ketorolac, ketorolac tromethamine; Lamifiban, lamotrigine, lanoteplase, lansoprazole, leflunomide, leuprorelin acetate, levetiracetam, levocetirizine, levodopa, lisinopril, loratadine; Manidipine, methylprednisolone, metronidazole, mirtazapine, mizolastine, modafinil, morphine sulfate; Naproxen sodium, naratriptan hydrochloride, nifedipine, NSC-683864; Ofloxacin, olanzapine, omalizumab, omapatrilat, ondansetron hydrochloride, oxcarbazepine; Paclitaxel, parecoxib sodium, paroxetine hydrochloride, phenytoin sodium, pimecrolimus, pramipexole hydrochloride, pravastatin, prednisone, pregabalin; Quetiapine fumarate; Ranitidine hydrochloride, rasburicase, ritonavir, rivastigmine tartrate, rizatriptan benzoate, rofecoxib; Saquinavir mesilate, sertraline, sildenafil citrate, simvastatin, sumatriptan succinate; Tacrolimus, tiagabine hydrochloride, ticlopidine hydrochloride, tirofiban hydrochloride, tolvaptan, topiramate, tretinoin; Valproic acid, valsartan, venlafaxine hydrochloride, verapamil; Warfarin sodium; Ximelagatran; Zanamivir, ziconotide, zolmitriptan, zonisamide. PMID:12168506

  12. Rationale for the tinnitus retraining therapy trial

    Directory of Open Access Journals (Sweden)

    Craig Formby

    2013-01-01

    Full Text Available The Tinnitus Retraining Therapy Trial (TRTT is a National Institutes of Health-sponsored, multi-centered, placebo-controlled, randomized trial evaluating the efficacy of tinnitus retraining therapy (TRT and its component parts, directive counseling and sound therapy, as treatments for subjective debilitating tinnitus in the military. The TRTT will enroll 228 individuals at an allocation ratio of 1:1:1 to: (1 directive counseling and sound therapy using conventional sound generators; (2 directive counseling and placebo sound generators; or (3 standard of care as administered in the military. Study centers include a Study Chair′s Office, a Data Coordinating Center, and six Military Clinical Centers with treatment and data collection standardized across all clinics. The primary outcome is change in Tinnitus Questionnaire (TQ score assessed longitudinally at 3, 6, 12, and 18-month follow-up visits. Secondary outcomes include: Change in TQ sub-scales, Tinnitus Handicap Inventory, Tinnitus Functional Index, and TRT interview visual analog scale; audiometric and psychoacoustic measures; and change in quality of life. The TRTT will evaluate TRT efficacy by comparing TRT (directive counseling and conventional sound generators with standard of care; directive counseling by comparing directive counseling plus placebo sound generators versus standard of care; and sound therapy by comparing conventional versus placebo sound generators. We hypothesize that full TRT will be more efficacious than standard of care, directive counseling and placebo sound generators more efficacious than standard of care, and conventional more efficacious than placebo sound generators in habituating the tinnitus awareness, annoyance, and impact on the study participant′s life.

  13. Quality assessment of reports on clinical trials in the Journal of Hepatology

    DEFF Research Database (Denmark)

    Gluud, C; Nikolova, D

    1998-01-01

    Electronic searches on databases for randomised clinical trials and controlled clinical trials do not identify as many trials as handsearches, and trial reporting may be flawed. The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make a qual...

  14. Quality assessment of reports on clinical trials in the Journal of Hepatology

    DEFF Research Database (Denmark)

    Gluud, C; Nikolova, D

    1998-01-01

    Electronic searches on databases for randomised clinical trials and controlled clinical trials do not identify as many trials as handsearches, and trial reporting may be flawed. The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make a qualitative assessment of the reporting.

  15. Spatiotemporal dynamics of random stimuli account for trial-to-trial variability in perceptual decision making.

    Science.gov (United States)

    Park, Hame; Lueckmann, Jan-Matthis; von Kriegstein, Katharina; Bitzer, Sebastian; Kiebel, Stefan J

    2016-01-01

    Decisions in everyday life are prone to error. Standard models typically assume that errors during perceptual decisions are due to noise. However, it is unclear how noise in the sensory input affects the decision. Here we show that there are experimental tasks for which one can analyse the exact spatio-temporal details of a dynamic sensory noise and better understand variability in human perceptual decisions. Using a new experimental visual tracking task and a novel Bayesian decision making model, we found that the spatio-temporal noise fluctuations in the input of single trials explain a significant part of the observed responses. Our results show that modelling the precise internal representations of human participants helps predict when perceptual decisions go wrong. Furthermore, by modelling precisely the stimuli at the single-trial level, we were able to identify the underlying mechanism of perceptual decision making in more detail than standard models. PMID:26752272

  16. Future vision for the quality assurance of oncology clinical trials

    Directory of Open Access Journals (Sweden)

    ThomasFitzGerald, MD

    2013-03-01

    Full Text Available The National Cancer Institute clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence based process improvements for clinical oncology patient care. The cooperative groups are undergoing a transformation process as we further integrate molecular biology into personalized patient care and move to incorporate international partners in clinical trials. To support this vision, data acquisition and data management informatics tools must become both nimble and robust to support transformational research at an enterprise level. Information, including imaging, pathology, molecular biology, radiation oncology, surgery, systemic therapy and patient outcome data needs to be integrated into the clinical trial charter using adaptive clinical trial mechanisms for design of the trial. This information needs to be made available to investigators using digital processes for real time data analysis. Future clinical trials will need to be designed and completed in a timely manner facilitated by nimble informatics processes for data management. This paper discusses both past experience and future vision for clinical trials as we move to develop data management and quality assurance processes to meet the needs of the modern trial.

  17. Towards a framework of success factors for clinical trials

    DEFF Research Database (Denmark)

    Buonansegna, Erika; Salomo, SØren

    2012-01-01

    Clinical trials in the pharmaceutical industry are the most critical part of the drug development process with respect to obtaining the market approval from the authorities. Clinical trials are highly expensive, time-consuming and often unsuccessful. While new product development (NPD) literature has extensively investigated success factors in R&D projects, it has not directly addressed success factors in clinical trials, as the late testing stage of a NPD yet. The aim of this paper is to enhance our understanding of the clinical trial management by creating a new conceptual framework of success factors. This paper creates the new framework by combining success factors from NPD literature and from empirical evidence collected through 11 semi-structured interviews with experts in clinical trials. The framework of success factors provides managerial guidelines for practitioners to optimize clinical trials reducing failures and increasing profits. The framework directs managerial focus on the most important factors for success and helps managers in decision-making of operational tasks. The framework can also be applied as a checklist for assessing the status of a clinical trial and later as a benchmarking tool to compare clinical trial processes. Dependencies among the identified factors seem to exist, thus a set of propositions, can be developed from the success factors and be the basis for future empirical testing.

  18. 75 FR 37380 - Trademark Trial and Appeal Board (TTAB) Actions

    Science.gov (United States)

    2010-06-29

    ... Patent and Trademark Office Trademark Trial and Appeal Board (TTAB) Actions ACTION: Proposed collection; comment request. SUMMARY: The United States Patent and Trademark Office (USPTO), as part of its continuing... following methods: E-mail: InformationCollection@uspto.gov . Include ``0651- 0040 Trademark Trial and...

  19. Book review: writing history in international criminal trials

    OpenAIRE

    O'Leary, Tara

    2012-01-01

    In this engaging and accessible book, Richard Ashby Wilson addresses key questions related to the legal relevance of history in international criminal trials. Should history play a role in trials, what form should it take, and why does it matter? What can history explain about criminal accountability, crimes under international law, and conflict? Reviewed by Tara O’Leary.

  20. Use of 'sham' radiotherapy in randomized clinical trials

    International Nuclear Information System (INIS)

    The objective of this systematic review was to identify quality trials that use sham radiotherapy in their design and review them to determine its potential value. The Cochrane Library, Pubmed and a Reference Search served as data sources. Trials were included if they met a minimum quality score of 3 on a validated assessment instrument (which assesses randomization, control and blinding) and if they compared sham radiotherapy to active treatment. External beam therapy and brachytherapy trials were considered. Twenty-six trials were identified, collectively including 2663 participants in the period of 1970-2004. All the trials studied the value of radiotherapy for treatment or prevention of benign diseases, including multiple sclerosis, coronary artery restenosis, age-related macular degeneration and Graves' ophthalmopathy. There were no trials relating to the use of radiotherapy in the treatment of malignancy. This review showed that it is possible to carry out sham radiotherapy with due regard for ethical concerns, with effective blinding and high levels of patient acceptance. Large sample sizes with multicentre trial designs were achievable. Although the statistical philosophy for using sham radiotherapy in trials is legitimate, it is no longer routinely used.