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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. 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

  3. 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...

  4. 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,...

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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).

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. 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

  16. 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.

  17. 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.

  18. 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...

  19. 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

  20. 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

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. [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

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

    DEFF Research Database (Denmark)

    Jemec, Gregor; Ullman, Susanne

    2009-01-01

    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).

  9. 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 ...

  10. 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 ...

  11. 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.

  12. 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.

  13. Clinical Trials

    Science.gov (United States)

    ... Clinical Trials Click here × Liam hopes for a future without blood cancers. You can help make someday ... contact an LLS Information Specialist, who can conduct personalized clinical trial searches and help you develop a list of ... Integrative Medicine and Complementary and Alternative Therapies Types of CAM ...

  14. 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 ...

  15. 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

  16. Clinical Trials - Participants

    Science.gov (United States)

    Clinical Trials — Participants Participate in a Clinical Trial Interested in information for researchers about clinical trials? NIMH supports a large number of research studies, including both laboratory and clinical ...

  17. 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 ...

  18. 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 ...

  19. 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.

  20. 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…

  1. 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.

  2. 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.

  3. 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...

  4. 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

  5. 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.

  6. 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

  7. Unknown properties of well-known zeolites. Transformation of hydrocarbons over ZSM-5.

    Czech Academy of Sciences Publication Activity Database

    Sazama, Petr; D?de?ek, Ji?í; Palumbo, L.; Bordiga, S.; Gábová, Vendula; Wichterlová, Blanka

    Bratislava : Slovak University of Technology, 2009 - (HorváthB, B.; Hronec, M.), s. 81-86 ISBN 978-80-227-2923-9. [Pannonian International Symposium of Technology /19./. Štrbské Pleso (SK), 08.09.2009-12.09.2009] R&D Projects: GA ?R GP203/08/P593 Institutional research plan: CEZ:AV0Z40400503 Keywords : zeolite s * ZSM-5 * analysis of Al distribution * catalytic activity of H+ Subject RIV: CF - Physical ; Theoretical Chemistry

  8. 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 ...

  9. 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.

  10. 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 ...

  11. 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

  12. 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. placebo on DLE lesions in a multicentre, double-blinded, randomized, placebo-controlled phase II trial. METHODS: Thirty-seven patients with at least one newly developed DLE lesion were randomized - 19 to the R...

  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. 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 ...

  15. 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 ...

  16. 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.

  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. [Fibrates in the light of large clinical trials].

    Science.gov (United States)

    Krysiak, Robert; Rudzki, Henryk; Handzlik-Orlik, Gabriela; Gdula-Dymek, Anna; Okopie?, Bogus?aw

    2015-04-01

    Peroxisome proliferator-activated receptor (PPAR)? activators (fibrates) are one of the major group of hypolipidemic agents, that have been presented to have clinical benefits in prevention and treatment of cardiovascular disorders. Apart from their well-known hypolipidemic properties, fibrates produce other so-called pleiotropic effects, including anti-inflammatory and anti-oxidant action, as well as reduction in procoagulant activity and improvement in endothelial function. These observations are in line with some of the results from large randomised clinical trials, which indicated the benefits from therapy with fibrates other than we could expect from their hypolipidemic properties. Nevertheless, the analysis of these studies supports the argument that patients with mixed dyslipidemia and carbohydrate metabolism disturbances are the group, which benefits the most from fibrate therapy. In this article, particular attention is devoted to the results of the large clinical trials. We try to explain the differences between the results of various studies. PMID:25938391

  19. 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 ...

  20. 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 ...

  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. 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 ...

  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. 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 ...

  5. 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...

  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. 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 Wednesday, December 23, 2015 HIV Antibody ...

  8. 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

  9. 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

  10. 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.

  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 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...

  12. 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...

  13. 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...

  14. 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.

  15. 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

  16. 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...

  17. 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.

  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 a...

  19. 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...

  20. 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

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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...

  6. 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

  7. 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.

  8. 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.

  9. 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.)

  10. 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.

  11. 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)

  12. 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

  13. 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

  14. 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...

  15. 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

  16. El antígeno carcinoembrionario: a propósito de un viejo conocido / The carcinoembryonic antigen: by the way a well-known friend

    Scientific Electronic Library Online (English)

    Félix Ignacio, Téllez-Ávila; Sandra Minerva, García-Osogobio.

    2005-12-01

    Full Text Available El antígeno carcinoembrionario (ACE) es una glucoproteína localizada en el polo apical de los enterocitos. Los genes que codifican para el ACE se localizan en el cromosoma 19q13.2. El grupo total está constituido por 29 genes, divididos en tres subgrupos de los cuales se expresan sólo 18. En el indi [...] viduo sano existen múltiples funciones del ACE que han sido ampliamente estudiadas, su función como molécula de adhesión ha sido la más ampliamente difundida. En pacientes sanos además de expresarse a nivel de colon el ACE se expresa en células de la lengua, esófago, estómago, cervix y próstata. Los pacientes que reciben una mayor utilidad clínica son aquellos con cáncer colorrectal (CCR), cáncer gástrico y cáncer de ovario. Su uso más amplio es en el CCR, actualmente se utiliza como marcador pronóstico, estadiaje, marcador de recurrencia, de respuesta al tratamiento y como indicador de metástasis a nivel hepático. Existen algunas patologías no neoplásicas que causan elevación de las cifras séricas de ACE. Actualmente se estudia al ACE como blanco de inmunoterapia dirigida a tumores que contengan células que expresen esta molécula Abstract in english The carcinoembryonic antigen (CEA) is glycoprotein localized in the apical surface of mature enterocytes. The members of the CEA gene family are clustered on chromosome 19q13.2. It is formed by 29 genes, of which 18 are expressed. Many functions of CEA have been known in healthy individuals, however [...] its role as cell adhesion molecule is the most studied. Besides the colon, CEA is expressed in the stomach, tongue, oesophagus, cervix, and prostate. The most important clinical function is in colorectal, gastric and ovary cancer. It is used as prognosis marker, staging system, recurrence, treatment response and liver metastases. There are many no neoplasic-diseases that enhance CEA value. Actually, the CEA is being studying as target of immunotherapy.

  17. 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...

  18. Gateways to clinical trials.

    Science.gov (United States)

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

    2005-12-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables 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: 131I-chTNT; Abatacept, adalimumab, alemtuzumab, APC-8015, aprepitant, atazanavir sulfate, atomoxetine hydrochloride, azimilide hydrochloride; Bevacizumab, bortezomib, bosentan, buserelin; Caspofungin acetate, CC-4047, ChAGCD3, ciclesonide, clopidogrel, curcumin, Cypher; Dabigatran etexilate, dapoxetine hydrochloride, darbepoetin alfa, darusentan, denosumab, DMXB-Anabaseine, drospirenone, drospirenone/estradiol, duloxetine hydrochloride, dutasteride; Edodekin alfa, efaproxiral sodium, elaidic acid-cytarabine, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, eszopiclone, etonogestrel/testosterone decanoate, exenatide; Fulvestrant; Gefitinib, glycine, GVS-111; Homoharringtonine; ICC-1132, imatinib mesylate, iodine (I131) tositumomab, i.v. gamma-globulin; Levetiracetam, levocetirizine, lintuzumab, liposomal nystatin, lumiracoxib, lurtotecan; Manitimus, mapatumumab, melatonin, micafungin sodium, mycophenolic acid sodium salt; Oblimersen sodium, OGX-011, olmesartan medoxomil, omalizumab, omapatrilat, oral insulin; Parathyroid hormone (human recombinant), pasireotide, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, phVEGF-A165, pimecrolimus, pitavastatin calcium, plerixafor hydrochloride, posaconazole, pramlintide acetate, prasterone, pregabalin, PT-141; Quercetin; Ranolazine, rosuvastatin calcium, rubitecan, rupatadine fumarate; Sardomozide, sunitinib malate; Tadalafil, talactoferrin alfa, tegaserod maleate, telithromycin, testosterone transdermal patch, TH-9507, tigecycline, tiotropium bromide, tipifarnib, tocilizumab, treprostinil sodium; Valdecoxib, vandetanib, vardenafil hydrochloride hydrate, voriconazole. PMID:16395422

  19. 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

  20. 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

  1. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2010-11-01

    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: Abatacept, Adalimumab, AdCD40L, Adefovir, Aleglitazar, Aliskiren fumarate, AM-103, Aminolevulinic acid methyl ester, Amlodipine, Anakinra, Aprepitant, Aripiprazole, Atazanavir sulfate, Axitinib; Belimumab, Bevacizumab, Bimatoprost, Bortezomib, Bupropion/naltrexone; Calcipotriol/betamethasone dipropionate, Certolizumab pegol, Ciclesonide, CYT-997; Darbepoetin alfa, Darunavir, Dasatinib, Desvenlafaxine succinate, Dexmethylphenidate hydrochloride cogramostim; Eltrombopag olamine, Emtricitabine, Escitalopram oxalate, Eslicarbazepine acetate, Eszopiclone, Etravirine, Everolimus-eluting coronary stent, Exenatide, Ezetimibe; Fenretinide, Filibuvir, Fludarabine; Golimumab; Hepatitis B hyperimmunoglobulin, HEV-239, HP-802-247, HPV-16/18 AS04, HPV-6/11/16/18, Human albumin, Human gammaglobulin; Imatinib mesylate, Inotuzumab ozogamicin, Invaplex 50 vaccine; Lapatinib ditosylate, Lenalidomide, Liposomal doxorubicin, Lopinavir, Lumiliximab, LY-686017; Maraviroc, Mecasermin rinfabate; Narlaprevir; Ocrelizumab, Oral insulin, Oritavancin, Oxycodone hydrochloride/naloxone; Paclitaxel-eluting stent, Palonosetron hydrochloride, PAN-811, Paroxetine, Pazopanib hydrochloride, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Pitavastatin calcium, Posaconazole, Pregabalin, Prucalopride succinate; Raltegravir potassium, Ranibizumab, RHAMM R3 peptide, Rosuvastatin calcium; Salclobuzic acid sodium salt, SCY-635, Selenate sodium, Semapimod hydrochloride, Silodosin, Siltuximab, Silybin, Sirolimus-eluting stent, SIR-Spheres, Sunitinib malate; Tapentadol hydrochloride, Tenofovir disoproxil fumarate, Tocilizumab, Tositumomab/iodine (I131) tositumomab, Trabectedin, TransVax™ hepatitis C vaccine; Ustekinumab; V-260, Valspodar, Varenicline tartrate, VCL-IPT1, Vildagliptin, VRC-HIVADV014-00-VP, VRC-HIVDNA009-00-VP, VRC-HIVDNA016-00-VP; Yttrium 90 (90Y) ibritumomab tiuxetan, Yttrium Y90 Epratuzumab; Zibotentan, Zotarolimus-eluting stent. PMID:21225019

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

    Science.gov (United States)

    Clinical Trials: Information and Options for People with Mood Disorders What are clinical trials? Clinical trials are research studies involving people, ... before the trial begins. What happens during a clinical trial? In some clinical trials, participants are given ...

  3. 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)

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. 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 ...

  9. 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.

  10. The ALCHEMIST Lung Cancer Trials

    Science.gov (United States)

    A collection of material about the ALCHEMIST lung cancer trials that will examine tumor tissue from patients with certain types of early-stage, completely resected non-small cell lung cancer for gene mutations in the EGFR and ALK genes, and assign patients with these gene mutations to treatment trials testing post-surgical use of drugs targeted against these mutations.

  11. 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

  12. Gateways to Clinical Trials.

    Science.gov (United States)

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

    2002-04-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the world's first drug discovery and development portal, and provides information on study design, treatments, conclusions and references. This issue focuses on the following selection of drugs: Abiciximab, acetylcholine chloride, acetylcysteine, alefacept, alemtuzumab, alicaforsen, alteplase, aminopterin, amoxicillin sodium, amphotericin B, anastrozole, argatroban monohydrate, arsenic trioxide, aspirin, atazanavir, atorvastatin, augmerosen, azathioprine; Benzylpenicillin, BMS-284756, botulinum toxin type A, botulinum toxin type B, BQ-123, budesonide, BXT-51072; Calcium folinate, carbamazepine, carboplatin, carmustine, ceftriaxone sodium, cefuroxime axetil, chorionic gonadotropin (human), cimetidine, ciprofloxacin hydrochloride, cisplatin, citalopram hydrobromide, cladribine, clarithromycin, clavulanic acid, clofarabine, clopidogrel hydrogensulfate, clotrimazole, CNI-1493, colesevelam hydrochloride, cyclophosphamide, cytarabine; Dalteparin sodium, daptomycin, darbepoetin alfa, debrisoquine sulfate, dexrazoxane, diaziquone, didanosine, docetaxel, donezepil, doxorubicin hydrochloride liposome injection, DX-9065a; Eberconazole, ecogramostim, eletriptan, enoxaparin sodium, epoetin, epoprostenol sodium, erlizumab, ertapenem sodium, ezetimibe; Fampridine, fenofibrate, filgrastim, fluconazole, fludarabine phosphate, fluorouracil, 5-fluorouracil/epinephrine, fondaparinux sodium, formoterol fumarate; Gabapentin, gemcitabine, gemfibrozil, glatiramer; Heparin sodium, homoharringtonine; Ibuprofen, iloprost, imatinib mesilate, imiquimod, interferon alpha-2b, interferon alpha-2c, interferon-beta; KW-6002; Lamotrigine, lanoteplase, metoprolol tartrate, mitoxantrone hydrochloride; Naproxen sodium, naratriptan, Natalizumab, nelfinavir mesilate, nevirapine, nifedipine, NSC-683864; Oral heparin; Paclitaxel, peginterferon alfa-2b, phenytoin, pimecrolimus, piperacillin, pleconaril, pramipexole hydrochloride, prednisone, pregabalin, progesterone; Rasburicase, ravuconazole, reteplase, ribavirin, rituximab, rizatriptan, rosiglitazone maleate, rotigotine; Semaxanib, sildenafil citrate, simvastatin, stavudine, sumatriptan; Tacrolimus, tamoxifen citrate, tanomastat, tazobactam, telithromycin, tenecteplase, tolafentrine, tolterodine tartrate, triamcinolone acetonide, trimetazidine, troxacitabine; Valproic acid, vancomycin hydrochloride, vincristine, voriconazole, Warfarin sodium; Ximelagatran, Zidovudine, zolmitriptan. PMID:12087878

  13. 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.

  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 variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialis...

  15. 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.

  16. 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-? 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.

  17. 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.

  18. Glossary of Clinical Trials Terms

    Science.gov (United States)

    ... Model (Design) . To Top D DATA MONITORING COMMITTEE (DMC) A group of independent scientists who monitor the ... Data Monitoring Committee data element on ClinicalTrials.gov.) DMC See Data Monitoring Committee (DMC) . DOUBLE BLIND MASKING ...

  19. 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...

  20. 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...

  1. Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Xie Cheng-long

    2013-01-01

    Full Text Available Abstract Background Insomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD is a well known classic Chinese herbal prescription for insomnia and has been treating people’s insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia. Methods A systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions. Results Twelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information. Conclusions Despite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well-designed RCTs are needed.

  2. 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 research studies ... aren’t infected with HIV. What is a clinical trial? A clinical trial is a research study ...

  3. 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,...

  4. 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....

  5. 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)...

  6. 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

  7. 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.

  8. 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.

  9. 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 ...

  10. 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 ...

  11. 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 ...

  12. 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.

  13. 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 ...

  14. 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...

  15. Clinical trials update 2014: year in review.

    Science.gov (United States)

    Peroutka, Stephen J

    2015-01-01

    This section of Headache annually reviews the status of recently completed and ongoing major clinical trials involving common headache disorders. The review will focus on multicenter trials of new therapies as well as novel formulations of previously approved therapeutics. Table?1 summarizes the major therapeutic headache trials that were ongoing at the end of 2014, according to data obtained from both the "ClinicalTrials.Gov" website and from corporate press releases and presentations. PMID:25522893

  16. 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…

  17. 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.

  18. 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 ...

  19. 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.

  20. 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...

  1. 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

  2. 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...

  3. 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...

  4. Lattice sieving and trial division

    OpenAIRE

    Golliver, R. A.; Lenstra, Arjen K.; McCurley, K. S.

    1994-01-01

    Reports on work in progress on our new implementation of the relation collection stage of the general number field sieve integer factoring algorithm. Our experiments indicate that we have achieved a substantial speed-up compared to other implementations that are reported in the literature. The main improvements are a new lattice sieving technique and a trial division method that is based on lattice sieving in a hash table. This also allows us to collect triple and quadruple large prime relati...

  5. 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...

  6. Human clinical trials in antiepileptogenesis

    OpenAIRE

    Mani, Ram; Pollard, John; Dichter, Marc A.

    2011-01-01

    Blocking the development of epilepsy (epileptogenesis) is a fundamental research area with the potential to provide large benefits to patients by avoiding the medical and social consequences that occur with epilepsy and lifelong therapy. Human clinical trials attempting to prevent epilepsy (antiepileptogenesis) have been few and universally unsuccessful to date. In this article, we review data about possible pathophysiological mechanisms underlying epileptogenesis, discuss potential intervent...

  7. COMPETING COMMITMENTS in CLINICAL TRIALS

    OpenAIRE

    Lidz, Charles W; Appelbaum, Paul S; Joffe, Steven; Albert, Karen; Rosenbaum, Jill; Simon, Lorna

    2009-01-01

    Most discussion about clinical care in clinical trials has concerned whether subjects’ care may be compromised by research procedures. The possibility that clinical researchers might give priority to helping their “patients” even if that required deviating from the imperatives of the research protocol largely has been ignored. We conducted an on-line survey with clinical researchers, including physicians, research nurses and other research staff, to assess the ways and frequency with which cl...

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

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

    Science.gov (United States)

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

    2014-10-01

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

  16. 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

  17. 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 ...

  18. 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

  19. 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...

  20. The Virtual International Stroke Trials Archive

    OpenAIRE

    ALI, M.; Bath, P.M.W.; Curram, J.; S. M. Davis; Diener, H. -C; Donnan, G A; Fisher, M; Gregson, B. A.; Grotta, J.; HACKE, W; Hennerici, M. G.; Hommel, M.; Kaste, M.; Marler, J.R.; Sacco, R L.

    2007-01-01

    Background and Purpose - Stroke has global importance and it causes an increasing amount of human suffering and economic burden, but its management is far from optimal. The unsuccessful outcome of several research programs highlights the need for reliable data on which to plan future clinical trials. The Virtual International Stroke Trials Archive aims to aid the planning of clinical trials by collating and providing access to a rich resource of patient data to perform exploratory analy...

  1. Clinical trials: innovation, progress and controversy

    OpenAIRE

    Martin GS

    2011-01-01

    Greg S MartinDepartment of Pulmonary, Allergy and Critical Care, Emory University, Atlanta, Georgia, USAThe Open Access Journal of Clinical Trials began in 2009 with the goal of being an authoritative, open access source for international, peer-reviewed publications in the field of human research and clinical trials. Since then, the Open Access Journal of Clinical Trials has published approximately 30 high-quality articles on original research, innovative reviews, and critical commentaries. T...

  2. 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.

  3. 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.

  4. 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...

  5. Generalisability of results from randomised drug trials. A trial on antimanic treatment

    DEFF Research Database (Denmark)

    Licht, R W; Gouliaev, G

    1997-01-01

    Exemplified by a randomised trial on antimanic treatment, this paper addresses the question of whether selection of patients for drug trials may limit the applicability of study results from the randomised patients to a wider population.

  6. 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

  7. ?????????????? 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.

  8. 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...

  9. 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...

  10. 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...

  11. 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.

  12. 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

  13. 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 ...

  14. 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 ").

  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. 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.

  17. 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.

  18. 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

  19. 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.)

  20. 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...

  1. 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

  2. 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

  3. 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.

  4. 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.

    2015-01-01

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

  5. 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.

  6. 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

  7. 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.

  8. 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

  9. Justifying clinical trials for porcine islet xenotransplantation.

    Science.gov (United States)

    Ellis, Cara E; Korbutt, Gregory S

    2015-09-01

    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

  10. 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

  11. 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

  12. Stimulation of the autonomic nervous system in colorectal surgery: a study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Berghmans Tim MP

    2012-06-01

    Full Text Available Abstract Background Postoperative ileus (POI is a well-known complication of abdominal surgery and is considered to be caused by a local inflammation in the gut. Previously it has been shown that both local and systemic inflammation can be reduced by stimulation of the autonomic nervous system via lipid rich nutrition. Stimulation of the autonomic nervous system releases acetylcholine from efferent vagal nerve endings that binds to nicotinic receptors located on the inflammatory cells leading to a decrease of pro-inflammatory mediators. Besides administration of nutrition there are other ways of stimulating the autonomic nervous system such as gum chewing. Methods/design This prospective, placebo-controlled randomized trial will include 120 patients undergoing colorectal surgery which are randomized for gum chewing preoperatively and in the direct postoperative phase or a placebo. Postoperative ileus will be assessed both clinically by time to first flatus and time to first defecation and by determination of gastric motility using ultrasound to measure dimensions of the antrum. Furthermore the inflammatory response is quantified by analyzing pro-inflammatory mediators. Finally, markers of gut barrier integrity will be measured as well as occurrence of postoperative complications. Discussion We hypothesize that chewing gum preoperatively and in the direct postoperative phase in patients undergoing colorectal surgery dampens local and systematic inflammation, via activation of the autonomic nervous system. Down-regulation of the inflammatory cascade via stimulation of the vagus nerve will ameleriote POI and enhance postoperative recovery. Trial registration NTR2867

  13. 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.

  14. 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

  15. 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...

  16. 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

  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. 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

  19. 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

  20. 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)

  1. Wireless Pacemaker Shows Promise in Early Trial

    Science.gov (United States)

    ... nlm.nih.gov/medlineplus/news/fullstory_154399.html Wireless Pacemaker Shows Promise in Early Trial Though it ... MONDAY, Aug. 31, 2015 (HealthDay News) --A tiny, wireless heart pacemaker showed promise in early tests and ...

  2. 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)

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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...

  8. The AIDS Clinical Trials Information Service (ACTIS): a decade of providing clinical trials information.

    OpenAIRE

    Katz, Deborah G.; Dutcher, Gale A.; Toigo, Theresa A.; Bates, Ruthann; Temple, Freda; Cadden, Cynthia G.

    2002-01-01

    The AIDS Clinical Trials Information Service (ACTIS) is a central resource for information about federally and privately funded HIV/AIDS clinical trials. Sponsored by four components of the U.S. Department of Health and Human Services, ACTIS has been a key part of U.S. HIV/AIDS information and education services since 1989. ACTIS offers a toll-free telephone service, through which trained information specialists can provide callers with information about AIDS clinical trials in English or Spa...

  9. 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...

  10. Rationale for the tinnitus retraining therapy trial

    OpenAIRE

    Formby, Craig; Scherer, Roberta

    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...

  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. 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 ...

  13. 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...

  14. Clinical trials of treatment for personality disorders.

    Science.gov (United States)

    Paris, Joel

    2008-09-01

    The objective of this review is to examine clinical trials of the treatment of personality disorders (PDs). The method is a narrative review of published controlled trials of psychotherapy and pharmacotherapy. Results show that a variety of methods reduce impulsivity, with less striking results for affective instability. There is good support for well-structured methods of psychotherapy, mainly in borderline personality disorder (BPD), but evidence for the efficacy of pharmacotherapy is weak. Research on other PD categories is sparse. PMID:18638650

  15. Ethical Issues in Clinical Trials Involving Nanomedicine

    OpenAIRE

    David B. Resnik; Tinkle, Sally S.

    2006-01-01

    Nanomedicine shows tremendous promise for improving medical diagnosis, treatment, and prevention, but it also raises a variety of ethical concerns. Because of the paucity of data on the physicochemical properties of nanoscale materials in biological systems, clinical trials of nanomedicine products present some unique challenges related to risk minimization, management and communication involving human subjects. Although these clinical trials do not raise any truly novel ethical issues, the r...

  16. DESIGNING PHASE 0 CANCER CLINICAL TRIALS

    OpenAIRE

    Murgo, Anthony J.; Kummar, Shivaani; Rubinstein, Larry; Gutierrez, Martin; Collins, Jerry; Kinders, Robert; Parchment, Ralph E.; Ji, Jiuping (Jay); Steinberg, Seth M; Yang, Sherry X.; Hollingshead, Melinda; Chen, Alice; Helman, Lee; Wiltrout, Robert; Tomaszewski, Joseph E.

    2008-01-01

    Phase 0 trials are designed primarily to evaluate the pharmacodynamic and/or pharmacokinetic properties of selected investigational agents prior to initiating more traditional phase 1 testing. One of the major objectives of phase 0 trials is to interrogate and refine a target or biomarker assay for drug effect in human samples implementing procedures developed and validated in preclinical models. Thus, close collaboration between laboratory scientists and clinical investigators is essential t...

  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. 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...

  19. 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...

  20. 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...

  1. 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

    2011-01-01

    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 trials. Methods Randomised phase III trials on adult patients with gastrointestinal diseases registered before January 2009 in http://ClinicalTrials.gov were eligible for inclusion. From http://ClinicalTrials.gov all data elements in the database required by the International Committee of Medical Journal 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 elements of the required ICMJE data list were not filled in, with missing data in 22% and 11%, respectively, of cases concerning the primary outcome measure and sample size. In 26% of the published papers, data on sample size calculations were missing and discrepancies between sample size reporting in http://ClinicalTrials.gov and published trials existed. Conclusion The quality of registration of randomised controlled trials still needs improvement.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. Narrating the Mensalão trial: : configurations of corruption

    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 social actors besides those on trial. Viewing corruption as the thematic focus of the media texts, this wider scope of enquiry into the mensalão affair allows us to see that media, political actors and institutions use cases of corruption for much more than mere condemnation of transgressions: The narratives constructed in the Brazilian media reflect but also produce a series of salient political and social developments in the nation's self-imagination and political arena.

  9. 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.

  10. 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

  11. 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

  12. 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.

  13. 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

  14. 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.

  15. 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.)

  16. 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

  17. 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

  18. 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

  19. 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...

  20. Powered toothbrushes: a review of clinical trials.

    Science.gov (United States)

    Heasman, P A; McCracken, G I

    1999-07-01

    There is now a vast range of powered toothbrushes (PTBs) available on the market and the efficacy of each product is usually determined in one, or a series of controlled clinical trials. This article reviews briefly the design of PTBs, some of the proposed indications for their use, and the principal observations from published studies of these products. The important issues regarding the regulation and design of trials involving PTBs are discussed and some recommendations are proposed with a view to developing a more structured approach to testing these products. PMID:10412844

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. Randomized controlled trials of malaria intervention trials in Africa, 1948 to 2007: a descriptive analysis

    Directory of Open Access Journals (Sweden)

    Gerritsen Annette

    2011-03-01

    Full Text Available Abstract Background Nine out of ten deaths from malaria occur in sub-Saharan Africa. Various control measures have achieved some progress in the control of the disease, but malaria is still a major public health problem in Africa. Randomized controlled trials (RCTs are universally considered the best study type to rigorously assess whether an intervention is effective. The study reported here provides a descriptive analysis of RCTs reporting interventions for the prevention and treatment of malaria conducted in Africa, with the aim of providing detailed information on their main clinical and methodological characteristics, that could be used by researchers and policy makers to help plan future research. Methods Systematic searches for malaria RCTs were conducted using electronic databases (Medline, Embase, the Cochrane Library, and an African geographic search filter to identify RCTs conducted in Africa was applied. Results were exported to the statistical package STATA 8 to obtain a random sample from the overall data set. Final analysis of trial characteristics was done in a double blinded fashion by two authors using a standardized data extraction form. Results A random sample of 92 confirmed RCTs (from a total of 943 reports obtained between 1948 and 2007 was prepared. Most trials investigated drug treatment in children with uncomplicated malaria. Few trials reported on treatment of severe malaria or on interventions in pregnant women. Most trials were of medium size (100-500 participants, individually randomized and based in a single centre. Reporting of trial quality was variable. Although three-quarter of trials provided information on participants' informed consent and ethics approval, more details are needed. Conclusions The majority of malaria RCT conducted in Africa report on drug treatment and prevention in children; there is need for more research done in pregnant women. Sources of funding, informed consent and trial quality were often poorly reported. Overall, clearer reporting of trials is needed.

  6. 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.

  7. 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.

  8. 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

  9. 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…

  10. [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

  11. 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…

  12. 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.

  13. 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.

  14. 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...

  15. 25 CFR 11.314 - Jury trials.

    Science.gov (United States)

    2010-04-01

    ...INTERIOR LAW AND ORDER COURTS OF INDIAN OFFENSES AND LAW AND ORDER CODE Criminal Procedure § 11.314 Jury trials...the prosecutor informs the court before the case comes to...the prosecutor informs the court that no sentence of...

  16. Discipline Goes on Trial at Colleges

    Science.gov (United States)

    Lipka, Sara

    2009-01-01

    Conduct officers have been moving away from the legalistic disciplinary systems that colleges built in the latter half of the 20th century on the belief that they'd lose lawsuits without them. Confident now that judges won't expect those systems to conform to the rules of criminal procedure, colleges are making hearings less like trials, and more…

  17. 25 CFR 11.313 - Trial procedure.

    Science.gov (United States)

    2010-04-01

    ...ORDER CODE Criminal Procedure § 11.313 Trial procedure. (a) The time and place of court sessions, and all other details of judicial procedure shall be set out in rules of court approved by the chief magistrate of the Court of...

  18. 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)

  19. 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)

  20. Pipeline Decommissioning Trial AWE Berkshire UK - 13619

    International Nuclear Information System (INIS)

    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)

  1. Questions & Answers - NIH Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)

    Science.gov (United States)

    ... Questions and Answers: NIH Glucosamine/Chondroitin Arthritis Intervention Trial Primary Study On this page: About the Study ... Study What is the Glucosamine/chondroitin Arthritis Intervention Trial (GAIT)? GAIT is the first large-scale, multicenter ...

  2. Vaccine for Deadly Respiratory Virus Shows Promise in Early Trial

    Science.gov (United States)

    ... for Deadly Respiratory Virus Shows Promise in Early Trial Researcher hopes to see routine RSV immunization within ... similar vaccines are now being tested in clinical trials or will be tested soon. "We hope that ...

  3. Clinical Trials: A Crucial Key to Human Health Research

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: A Crucial Key to Human Health Research ... the forefront of human health research today are clinical trials—studies that use human volunteers to help ...

  4. Including Clinical Trials in Your Practice | accrualnet.cancer.gov

    Science.gov (United States)

    This resource is a Web-based course for healthcare providers who are interested in becoming clinical trials investigators and incorporating cancer clinical trials into their practices. A certificate of completion is offered at the end of the course.

  5. Lead editorial: Trials – using the opportunities of electronic publishing to improve the reporting of randomised trials

    Directory of Open Access Journals (Sweden)

    Grimshaw Jeremy M

    2006-03-01

    Full Text Available Abstract This editorial introduces the new online, open access, peer-reviewed journal Trials. The journal considers manuscripts on any aspect of the design, performance, and findings of randomised controlled trials in any discipline related to health care, and also encourages the publication of protocols. Trialists will be able to provide the necessary detail for a true and complete scientific record. They will be able to communicate not only all outcome measures, as well as varying analyses and interpretations, but also in-depth descriptions of what they did and honest reflections about what they learnt. Trials also encourages articles covering generic issues related to trials, for example focussing on the design, conduct, analysis, interpretation, or reporting.

  6. 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)

  7. 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

  8. 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...

  9. 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

  10. Sharing clinical trial data on patient level: Opportunities and challenges

    OpenAIRE

    Franz Koenig; Jim Slattery; Trish Groves; Thomas Lang; Yoav Benjamini; Simon Day; Peter Bauer; Martin Posch

    2014-01-01

    In recent months one of the most controversially discussed topics among regulatory agencies, the pharmaceutical industry, journal editors, and academia has been the sharing of patient-level clinical trial data. Several projects have been started such as the European Medicines Agency´s (EMA) “proactive publication of clinical trial data”, the BMJ open data campaign, or the AllTrials initiative. The executive director of the EMA, Dr. Guido Rasi, has recently announced that clinical trial data o...

  11. 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). T...

  12. 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.

  13. 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...

  14. 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...

  15. 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...

  16. 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.

  17. A National Strategy to Develop Pragmatic Clinical Trials Infrastructure

    OpenAIRE

    Concannon, Thomas W.; Guise, Jeanne-Marie; Dolor, Rowena J; Meissner, Paul; Tunis, Sean; Krishnan, Jerry A; Pace, Wilson D.; Saltz, Joel; Hersh, William R; Michener, Lloyd; Carey, Timothy S

    2014-01-01

    An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols.

  18. 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...

  19. 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...

  20. 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...

  1. 32 CFR 9.6 - Conduct of the trial.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 1 2010-07-01 2010-07-01 false Conduct of the trial. 9.6 Section 9.6 National... TRIALS BY MILITARY COMMISSIONS OF CERTAIN NON-UNITED STATES CITIZENS IN THE WAR AGAINST TERRORISM § 9.6 Conduct of the trial. (a) Pretrial procedures—(1) Preparation of the Charges. The Prosecution...

  2. 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...

  3. 40 CFR 265.402 - 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 Chemical, Physical, and Biological Treatment § 265.402 Waste analysis and trial tests... analyses and trial treatment tests (e.g., bench scale or pilot plant scale tests); or (ii) Obtain...

  4. 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...

  5. 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...

  6. 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).

  7. Missing radiographic data handling in randomized clinical trials in rheumatoid arthritis.

    Science.gov (United States)

    Huang, Xiaohong; Jiao, Lixia; Wei, Lynn; Quan, Hui; Teoh, Leah; Koch, Gary G

    2013-01-01

    In recent years, there has been increasing interest in compounds that have potential to slow down the structural joint damage in rheumatoid arthritis (RA) patients. Radiographs are instrumental in assessing structure damage in RA. Radiographic analyses results have become essential in establishing a "delay in structural progression" claim in newly developed agents for the treatment of RA. It is well known that the radiographic progression data generally follow a nonnormal distribution that is loaded with excessive zeros. A special concern about the radiographic data analyses is the handling of the seemingly high rate of missing values due to dropout or unreadable images. There are no uniform ways to handle missing radiographic data, and such data usually show considerable sensitivity to the imputation method chosen under the complexity of the nonnormal data and the unique missing mechanism. In this research, we proposed both an innovative multiple-imputation algorithm and a novel method called the mean rank imputation method under the nonparametric framework for sensitivity analyses. A simulation study was designed using rank analysis of covariance (ANCOVA) to extensively assess and compare the finite performance of these two new methods along with four other missing data handling methods previously used in the RA trials, namely, linear extrapolation, last observation carried-forward (LOCF), median quartile bin imputation, and median imputation under various settings. Our simulation results suggest that the multiple-imputation algorithm, providing an mITT analysis population, yields an inflated type I error and artificially good power. The proposed mean rank imputation method, following a true ITT principle, both is powerful and maintains type I error at the nominal level. PMID:24138441

  8. 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...

  9. Uncertainty in the Translation of Preclinical Experiments to Clinical Trials. Why do Most Phase III Clinical Trials Fail?

    OpenAIRE

    Lowenstein, Pedro R; Castro, Maria G

    2009-01-01

    A large majority of Phase III, large scale, clinical trials will fail, including gene therapy trials. This paper attempts to address some of the causes that may have inadvertently led to such a high failure rate. After briefly reviewing the detailed and high quality work that goes both into the preparation and conduct of such large Phase III clinical trials, and the preclinical science that is used to support and originate such trials, this paper proposes a novel approach to translational med...

  10. Randomization in substance abuse clinical trials

    Directory of Open Access Journals (Sweden)

    Woolson Robert F

    2006-02-01

    Full Text Available Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Results Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. Conclusion We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn randomization schemes and other highly adaptive designs. In many instances, simple or blocked randomization with stratification on a major covariate or two will accomplish the same objectives as an urn or adaptive design, and it can do so with more simply implemented schedules and without the dangers of overmatching. Furthermore, the proper analysis, fully accounting for the stratified design, can be conducted.

  11. 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...

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. 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,...

  17. Veterinary oncology clinical trials: design and implementation.

    Science.gov (United States)

    Thamm, Douglas H; Vail, David M

    2015-08-01

    There has been a recent increase in interest among veterinarians and the larger biomedical community in the evaluation of novel cancer therapies in client-owned (pet) animals with spontaneous cancer. This includes novel drugs designed to be veterinary therapeutics, as well as agents for which data generated in animals with tumors may inform human clinical trial design and implementation. An understanding of the process involved in moving a therapeutic agent through the stages of clinical evaluation is critical to the successful implementation of clinical investigations, as well as interpretation of the veterinary oncology literature. This review outlines considerations in the design and conduct of the various phases of oncology clinical trials, along with recent adaptations/modifications of these basic designs that can enhance the generation of timely and meaningful clinical data. PMID:25582798

  18. 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.

  19. 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.

  20. Decision-Making Trial and Evaluation Laboratory

    OpenAIRE

    Elham Falatoonitoosi; Zulkiflle Leman; Shahryar Sorooshian; Meysam Salimi

    2013-01-01

    The aim of this study is introducing a technique to illuminate composite issue, aspects or system factors, the complicated problems need to be structured with graphical illustration and analyzed casual interdependence and influences throughout the organization. Decision-Making Trial and Evaluation Laboratory (DEMATEL) methodology is proposed to for researching and solving complex and intertwined problem groups because of its capability in verifying interdependence between variables and try to...

  1. 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

  2. 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...

  3. 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...

  4. 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 ...

  5. 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

  6. 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.

  7. 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...

  8. Immuno-contraception undergoing promising trials.

    Science.gov (United States)

    Koshy, L M

    1994-08-15

    Immuno-contraception instructs the body to recognize a self-molecule as foreign, so that the body attacks the molecule, thereby effecting contraception. When researchers in India were developing a contraceptive vaccine, they considered 3 things: the targeted molecule should be crucial for reproduction, it should be transient in nature, and the antibodies against this molecule should not cross-react with other molecules in the body. They have developed a vaccine using beta-human chorionic gonadotropin (hCG). The pregnant woman's body produces beta-hCG. It sustains the corpus luteum for production of progesterone which induces changes in the uterus conducive to implantation of the zygote. Researchers have linked beta-hCG with a carrier molecule (tetanus toxoid or diphtheria) to induce an immune attack. They have successfully completed phase 2 efficacy trials. This vaccine also protects against tetanus or diphtheria. Animal studies show that it does not have any harmful side effects and is reversible. The phase 2 trials included women with 2 children cohabiting with fertile partners. Once the antibody titres surpassed the protective threshold, they discontinued contraceptive use and any avoided pregnancies would be attributed to the vaccine alone. The trials exceeded the norm of 750 protected menstrual cycles for the vaccine to be considered efficacious in April 1993. Researchers continued to monitor the women until their anti-beta-hCG titres reached a near-zero level. They are now ready to begin phase 3 trials. Logistical obstacles to overcome are a 2 month-lapse between 1st dose and sufficient titres to protect against pregnancy and multiple injections. Neem oil use may provide protection during the lag phase since it stimulates immune cells in the reproductive tract and has embryocidal and spermicidal effects. A single injection of biodegradable microcarrier systems releasing the vaccine may address the problem with multiple doses. PMID:12179186

  9. 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

  10. 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.

  11. 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...

  12. 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.

    2001-01-01

    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 paper summarises the results of the whole-body photon dosemeter test. Twenty-six dosimetry services from all EU Member States and Switzerland participated. Twelve different radiation fields were used to ...

  13. 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...

  14. Propensity Score Matching in Randomized Clinical Trials

    OpenAIRE

    Xu, Zhenzhen; Kalbfleisch, John D.

    2010-01-01

    Cluster randomization trials with relatively few clusters have been widely used in recent years for evaluation of health care strategies. On average, randomized treatment assignment achieves balance in both known and unknown confounding factors between treatment groups, however, in practice investigators can only introduce a small amount of stratification and cannot balance on all the important variables simultaneously. The limitation arises especially when there are many confounding variable...

  15. Clinical trials for stem cell therapies

    Directory of Open Access Journals (Sweden)

    Lomax Geoff

    2011-05-01

    Full Text Available Abstract In recent years, clinical trials with stem cells have taken the emerging field in many new directions. While numerous teams continue to refine and expand the role of bone marrow and cord blood stem cells for their vanguard uses in blood and immune disorders, many others are looking to expand the uses of the various types of stem cells found in bone marrow and cord blood, in particular mesenchymal stem cells, to uses beyond those that could be corrected by replacing cells in their own lineage. Early results from these trials have produced mixed results often showing minor or transitory improvements that may be attributed to extracellular factors. More research teams are accelerating the use of other types of adult stem cells, in particular neural stem cells for diseases where beneficial outcome could result from either in-lineage cell replacement or extracellular factors. At the same time, the first three trials using cells derived from pluripotent cells have begun.

  16. 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

  17. 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

  18. 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

  19. Biomarker-based trials in neuro-oncology.

    Science.gov (United States)

    Ballman, Karla V

    2015-09-01

    Treatment of brain tumors is increasingly informed by biomarkers. One use is to appropriately group tumors with similar genetic/genomic characteristics and to design trials separately for the individual groups. The biomarker's use is to predict patient response so that the most effective treatment can be selected for patients based on their tumor characteristics. Trial designs that recruit unselected patients are poorly suited for identifying treatments effective only in subsets of patients given the relatively small numbers of patients available for trials. Investigators are beginning to use different designs that better account for tumor heterogeneity. In this article, an overview of the role of biomarkers in brain tumor trials is presented in the context of existing clinical trials as well as trials that may be launched within the next several years. PMID:26408305

  20. 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...

  1. 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.

  2. 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)

  3. 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...

  4. 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)

  5. 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....

  6. Implications of HIV PrEP Trials Results

    OpenAIRE

    Veronese, Fulvia; Anton, Peter; Fletcher, Courtney V.; DeGruttola, Victor; MCGOWAN, Ian; Becker, Stephen; Zwerski, Sheryl; Burns, David

    2011-01-01

    Six randomized clinical trials have been implemented to examine the efficacy of tenofovir disoproxil fumarate (TDF) and/or TDF/emtricitabine (TDF/FTC) as preexposure prophylaxis for HIV-1 infection (PrEP). Although largely complementary, the six trials have many similar features. As the earliest results become available, an urgent question may arise regarding whether changes should be made in the conduct of the other trials. To consider this in advance, a Consultation on the Implications of H...

  7. 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.

  8. 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...

  9. 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...

  10. 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 ...

  11. Assessing the generalizability of randomized trial results to target populations.

    Science.gov (United States)

    Stuart, Elizabeth A; Bradshaw, Catherine P; Leaf, Philip J

    2015-04-01

    Recent years have seen increasing interest in and attention to evidence-based practices, where the "evidence" generally comes from well-conducted randomized trials. However, while those trials yield accurate estimates of the effect of the intervention for the participants in the trial (known as "internal validity"), they do not always yield relevant information about the effects in a particular target population (known as "external validity"). This may be due to a lack of specification of a target population when designing the trial, difficulties recruiting a sample that is representative of a prespecified target population, or to interest in considering a target population somewhat different from the population directly targeted by the trial. This paper first provides an overview of existing design and analysis methods for assessing and enhancing the ability of a randomized trial to estimate treatment effects in a target population. It then provides a case study using one particular method, which weights the subjects in a randomized trial to match the population on a set of observed characteristics. The case study uses data from a randomized trial of school-wide positive behavioral interventions and supports (PBIS); our interest is in generalizing the results to the state of Maryland. In the case of PBIS, after weighting, estimated effects in the target population were similar to those observed in the randomized trial. The paper illustrates that statistical methods can be used to assess and enhance the external validity of randomized trials, making the results more applicable to policy and clinical questions. However, there are also many open research questions; future research should focus on questions of treatment effect heterogeneity and further developing these methods for enhancing external validity. Researchers should think carefully about the external validity of randomized trials and be cautious about extrapolating results to specific populations unless they are confident of the similarity between the trial sample and that target population. PMID:25307417

  12. 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...

  13. Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials.

    Science.gov (United States)

    Kim, Young-Dae; Heo, In; Shin, Byung-Cheul; Crawford, Cindy; Kang, Hyung-Won; Lim, Jung-Hwa

    2013-01-01

    To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD) in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were "acupuncture" and "PTSD." No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs) and 2 uncontrolled clinical trials (UCTs) out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT) were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs). One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD. PMID:23476697

  14. The Cessation in Pregnancy Incentives Trial (CPIT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tappin David M

    2012-07-01

    Full Text Available Abstract Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010 highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n?=?600 will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an efficient trial design without introducing outcome bias? Can incentives be introduced in a way that is feasible and acceptable? Discussion This phase II trial will establish a workable design to reduce the risks associated with a future definitive phase III multicenter randomized controlled trial and establish a framework to assess the costs and benefits of financial incentives to help pregnant smokers to quit. Trial registration Current Controlled Trials ISRCTN87508788

  15. 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...

  16. Phase 0 Trials: Expediting the Development of Chemoprevention Agents

    OpenAIRE

    Kummar, Shivaani; DOROSHOW, JAMES H

    2011-01-01

    Phase 0 trials are first-in-human clinical trials performed under the Exploratory IND [investigational new drug] Guidance of the US Food and Drug Administration. Unlike traditional phase I trials, these studies have no therapeutic or diagnostic intent but instead aim to provide only pharmacokinetic and/or pharmacodynamic data to inform the next step in developing an agent. We discuss the role that such trials, including one reported by Reid et al. (beginning on page XXX in this issue of the j...

  17. 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

  18. 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.

  19. 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

  20. Prevention and intervention trials for colorectal cancer.

    Science.gov (United States)

    Komiya, Masami; Fujii, Gen; Takahashi, Mami; Iigo, Masaaki; Mutoh, Michihiro

    2013-07-01

    There have been a number of candidates for chemopreventive agents from synthetic drugs and natural compounds suggested to prevent colorectal cancer. However, they have shown modest efficacy in humans. The reason for this could be partly explained by the use of inappropriate models in vitro and in vivo, and the limitation of chemoprevention trials. In Japan, there are no cancer chemopreventive medicines, and few cancer chemoprevention trials to date. In contrast, an increase in the prevalence of colorectal cancer in Japan has forced us to develop more efficient chemopreventive strategies. It is now a good time to review in detail the current status and future prospects for chemoprevention of colorectal cancer with respect to the future development of chemopreventive medicines, particularly using synthetic drugs and natural compounds in Asian populations. The role and mode of action of available synthetic drugs, mainly aspirin and metformin, are reviewed. In addition, the possible impact of natural compounds with anti-inflammatory/immunosuppressive properties, such as ?3 polyunsaturated fatty acid and lactoferrin, are also reviewed. PMID:23613189

  1. 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.

  2. 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

  3. Alzheimer's disease: clinical trials and drug development.

    Science.gov (United States)

    Mangialasche, Francesca; Solomon, Alina; Winblad, Bengt; Mecocci, Patrizia; Kivipelto, Miia

    2010-07-01

    Alzheimer's disease is the most common cause of dementia in elderly people. Research into Alzheimer's disease therapy has been at least partly successful in terms of developing symptomatic treatments, but has also had several failures in terms of developing disease-modifying therapies. These successes and failures have led to debate about the potential deficiencies in our understanding of the pathogenesis of Alzheimer's disease and potential pitfalls in diagnosis, choice of therapeutic targets, development of drug candidates, and design of clinical trials. Many clinical and experimental studies are ongoing, but we need to acknowledge that a single cure for Alzheimer's disease is unlikely to be found and that the approach to drug development for this disorder needs to be reconsidered. Preclinical research is constantly providing us with new information on pieces of the complex Alzheimer's disease puzzle, and an analysis of this information might reveal patterns of pharmacological interactions instead of single potential drug targets. Several promising randomised controlled trials are ongoing, and the increased collaboration between pharmaceutical companies, basic researchers, and clinical researchers has the potential to bring us closer to developing an optimum pharmaceutical approach for the treatment of Alzheimer's disease. PMID:20610346

  4. The ONTARGET trial programme : Facts and lessons

    DEFF Research Database (Denmark)

    Unger, Thomas; Kintscher, Ulrich

    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 the parallel TRANSCEND study, nearly 6.000 patients, all intolerant to ACE inhibition, were subjected to telmisartan or placebo. In ONTARGET, telmisartan proved to be non-inferior to ramipril with respect to the combined primary endpoint and all secondary endpoints, and was better tolerated than ramipril. Combination treatment (dual RAS blockade) was not superior to ramipril (and telmisartan-) treatment but associated with more side effects. In TRANSCEND, telmisartan was not superior to placebo when applying the abovecombined primary endpoint but was significantly better with respect to the predefined main secondary endpoint corresponding to HOPE, i.e. excluding hospitalization for congestive heart failure. Telmisartan thus proved to be the first and so far the only representative of the ARB class that can be used as an alternative to the "gold standard" ACE-inhibitor, ramipril, in patients at high cardiovascular risk with or without hypertension. © 2009 Bentham Science Publishers Ltd.

  5. 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

  6. [Depression and legal capacity to stand trial].

    Science.gov (United States)

    Bolecha?a, Filip; Skupie?, Elzbieta

    2006-01-01

    The criteria for assessment of legal capacity to stand trial have long been a significant issue in the Polish criminal law. The main problem in opinionating practice is the fact that the code of penal procedure and the executive penal code do not provide any univocal criteria of a mental disease that should be met according to the legal regulations in force. Because of their nature and lack of uniformity, depression and affective disorders pose a particularly great problem for experts who should opinionate on the legal capacity of the suspected and the accused to stand trial. On the one hand, it cannot be accepted that a mental illness renders a person unable to substantially understand legal proceedings and to make a rational defense. On the other hand, however, emotional reactions and mild-degree depression disorders that are only natural when an individual violates law should not be allowed to be regarded as a grave disease and to paralyze legal proceedings. In the present study, the authors have attempted to describe the guidelines that should be followed by court-appointed experts in psychiatry that are commissioned by the court to assess the mental state of an individual. The report emphasizes that in such cases, a thorough analysis, based on medical and legal premises and the experience of the involved court experts are necessary. PMID:16708615

  7. 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

  8. 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...

  9. 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...

  10. Categorization of field trials with GM plants in the Netherlands: applicable to field trials with GM forest trees?

    OpenAIRE

    Glandorf DCM

    2014-01-01

    In the Netherlands, criteria have been set for field trials with genetically modified (GM) plants. These criteria are based on the step-by-step principle as described in European Directive 2001/18/EC. Three categories of field trials are defined. The first category concerns small-scale field trials with GM plants that are not well characterised on the molecular and phenotypic level. Confinement measures are applied in order to limit potential adverse effects to the field location. The second ...

  11. 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...

  12. 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 ...

  13. Meta-analysis of efficacy and safety of intravenous ferric carboxymaltose (Ferinject) from clinical trial reports and published trial data

    OpenAIRE

    Gaskell Helen; Moore R Andrew; Rose Peter; Allan Jonathan

    2011-01-01

    Abstract Background Recommendations given for intravenous iron treatment are typically not supported by a high level of evidence. This meta-analysis addressed this by summarising the available date from clinical trials of ferric carboxymaltose using clinical trial reports and published reports. Methods Clinical trial reports were supplemented by electronic literature searches comparing ferric carboxymaltose with active comparators or placebo. Various outcomes were sought for efficacy (attainm...

  14. 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.

  15. 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...

  16. 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.

  17. The Hidden Economic Impact of Non-enrolling Clinical Trials from the Academic Medical Center Perspective | accrualnet.cancer.gov

    Science.gov (United States)

    This study compares oncology and nononcology clinical trial accrual performance and assesses the economic impact of these trials at a single institution. For this assessment, terminated trials resulting in 0 or 1 accruals were defined as nonenrolling trials. The number of nonenrolling sites was stratified by oncology and nononcology trials and summarized across funding mechanisms categorized by industry, institutional, federal, and nonfunded trials. The percentage of nonenrolling trials was significantly greater for oncology trials (around 41%) compared with nononcology trials (around 25%).

  18. 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

  19. 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.

  20. 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.

  1. VAST: Vertebral Artery Stenting Trial. Protocol for a randomised safety and feasibility trial

    Directory of Open Access Journals (Sweden)

    Lo TH

    2008-11-01

    Full Text Available Abstract Background Twenty to 30 percent of all transient ischaemic attacks and ischaemic strokes involve tissue supplied by the vertebrobasilar circulation. Atherosclerotic stenosis ? 50% in the vertebral artery accounts for vertebrobasilar stroke in at least one third of the patients. The risk of recurrent vascular events in patients with vertebral stenosis is uncertain and revascularisation of vertebral stenosis is rarely performed. Observational studies have suggested that the risk of subsequent stroke or death in patients with vertebrobasilar ischaemic events is comparable with that in patients with carotid territory events. Treatment of vertebral stenosis by percutaneous transluminal angioplasty has been introduced as an attractive treatment option. The safety and benefit of stenting of symptomatic vertebral stenosis as compared with best medical therapy alone remains to be elucidated in a randomised clinical trial. Study objectives The primary aim of the Vertebral Artery Stenting Trial (VAST is to assess whether stenting for symptomatic vertebral artery stenosis ? 50% is feasible and safe. A secondary aim is to assess the rate of new vascular events in the territory of the vertebrobasilar arteries in patients with symptomatic vertebral stenosis ? 50% on best medical therapy with or without stenting. Design This is a randomised, open clinical trial, comparing best medical treatment with or without vertebral artery stenting in patients with recently symptomatic vertebral artery stenosis ? 50%. The trial will include a total of 180 patients with transient ischaemic attack or non-disabling ischaemic stroke attributed to vertebral artery stenosis ? 50%. The primary outcome is any stroke, vascular death, or non-fatal myocardial infarction within 30 days after start of treatment. Secondary outcome measures include any stroke or vascular death during follow-up and the degree of (restenosis after one year. Discussion Improvements both in imaging of the vertebral artery and in endovascular techniques have created new opportunities for the treatment of symptomatic vertebral artery stenosis. This trial will assess the feasibility and safety of stenting for symptomatic vertebral artery stenosis and will provide sufficient data to inform a conclusive randomised trial testing the benefit of this treatment strategy. The VAST is supported by the Netherlands Heart Foundation (2007B045; ISRCTN29597900.

  2. 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

  3. 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.

  4. Community Organizing for Database Trial Buy-In by Patrons

    Science.gov (United States)

    Pionke, J. J.

    2015-01-01

    Database trials do not often garner a lot of feedback. Using community-organizing techniques can not only potentially increase the amount of feedback received but also deepen the relationship between the librarian and his or her constituent group. This is a case study of the use of community-organizing techniques in a series of database trials for…

  5. 40 CFR 265.200 - 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 Tank Systems § 265.200 Waste analysis and trial tests. In addition to performing the... different process than any previously used in that tank system: (a) Conduct waste analyses and...

  6. Reforms speed initiation of NCI-sponsored clinical trials

    Science.gov (United States)

    The process of opening a cancer clinical trial for patient accrual often takes years, and research has shown that trials which are slow to register patients often fail to finish. Following a thorough review, NCI’s Operational Efficiency Working Group prod

  7. 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.

  8. An irrational trial equation method and its applications

    Indian Academy of Sciences (India)

    Xing-Hua Du

    2010-09-01

    An irrational trial equation method was proposed to solve nonlinear differential equations. By this method, a number of exact travelling wave solutions to the Burgers–KdV equation and the dissipative double sine-Gordon equation were obtained. A more general irrational trial equation method was discussed, and many exact solutions to the Fujimoto–Watanabe equation were given.

  9. 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.

  10. Disorder in the Court: America's High-Profile Trials.

    Science.gov (United States)

    Baker, Debra

    1999-01-01

    Discusses the U.S. public's fascination with the judicial system and high-profile court cases. Highlights several trials that have been deemed the "Trial of the 20th Century." Explains that there are certain dramatic and societal elements inherent in particular cases making them high profile, such as religion, racism, revenge, scandal, and fame.…

  11. Implementation of the NCI’s National Clinical Trials Network

    Science.gov (United States)

    NCI is launching a new clinical trials research network intended to improve treatment for the more than 1.6 million Americans diagnosed with cancer each year. The new system, NCI’s National Clinical Trials Network (NCTN), will facilitate the rapid initia

  12. Problems encountered in recruiting patients to an ophthalmic drug trial.

    OpenAIRE

    Quick, A. M.; Khaw, P. T.; Elkington, A R

    1989-01-01

    Two clinical trials to assess the efficacy of two topical beta-blocker preparations involved the recruitment of 60 and 40 patients respectively. The greatest obstacle encountered in carrying out the trials was recruiting patients. This difficulty is reported in detail and comparisons are made with the experience of others who have met similar problems.

  13. 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. 

  14. 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. Knovel?s 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...

  15. 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.

  16. 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

  17. European user trial of paging by satellite

    Science.gov (United States)

    Fudge, R. E.; Fenton, C. J.

    British Telecom conceived the idea of adapting their existing paging service, together with the use of existing terrestrial pagers, to yield a one way data (i.e., paging) satellite service to mobiles. The user trial of paging by satellites was successful. It demonstrated that services could be provided over a wide geographical area to low priced terminals. Many lessons were learned in unexpected areas. These include the need for extensive liaison with all users involved, especially the drivers, to ensure they understood the potential benefits. There was a significant desire for a return acknowledgement channel or even a return data channel. Above all there is a need to ensure that the equipment can be taken across European borders and legitimately used in all European countries. The next step in a marketing assessment would be to consider the impact of two way data messaging such as INMARSAT-C.

  18. Eurados trial performance test for photon dosimetry

    DEFF Research Database (Denmark)

    Stadtmann, H.; Bordy, J.M.

    2001-01-01

    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 paper summarises the results of the whole-body photon dosemeter test. Twenty-six dosimetry services from all EU Member States and Switzerland participated. Twelve different radiation fields were used to simulate various workplace irradiation fields. Dose values from 0.4 mSv to 80 mSv were chosen. From 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 results for this field are excluded, most participating services satisfied the evaluation criteria.

  19. 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.

  20. 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.

  1. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

    Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63%. Information about the caregivers was missing for 70% of trials. Most trials (73% took place in the United States or United Kingdom, 64% involved only one centre, and participating centers were mainly tertiary-care, academic or university hospitals (51%. Conclusions Educational interventions assessed in ongoing RCTs of educational interventions are poorly described in trial registries. The lack of adequate description raises doubts about the ability of trial registration to help patients and researchers know about the treatment evaluated in trials of education.

  2. 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

  3. Sample size determination in clinical trials with multiple endpoints

    CERN Document Server

    Sozu, Takashi; Hamasaki, Toshimitsu; Evans, Scott R

    2015-01-01

    This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clin...

  4. Placebo control and clinical trial of Chinese medicine

    Directory of Open Access Journals (Sweden)

    Jing Wu

    2010-10-01

    Full Text Available World Health Organization aims to develop safe, effective and practical traditional medicine. Traditional Chinese medicine (TCM and other complementary and alternative medicine are being recognized in the whole world nowadays. However, the definite effect of Chinese medicine is still in need of scientific research proof. Placebo control is of equal importance to active control and blank control in clinical trial of TCM. This article briefly reviewed the importance of placebo control and commented on its present situation in clinical trial of TCM. This article also brought up the preliminary proposals of placebo application in TCM clinical trial. We should emphasize scientific placebo preparation and good design of placebo-controlled trial, which are directed by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. A good clinical trial project will avoid unnecessary wastes and provide safe and effective treatment for people.

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

    OpenAIRE

    Burgess LJ; Sulzer NU

    2011-01-01

    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...

  6. First trial rewards promote 1-trial learning and prolonged memory in pigeon and baboon

    OpenAIRE

    Cook, Robert; Fagot, Joël

    2009-01-01

    There is a long-standing debate in educational settings on the influence of positive and negative consequences on learning. Although positive rewards seem desirable from an ethical perspective, 1-trial learning has been best demonstrated in the animal literature with tasks using highly salient negative consequences, such as shock or illness, and so far only in tasks requiring the acquisition of a singular stimulus-response association. Here we show that pigeons and baboons can concurrently le...

  7. Randomized controlled trials of malaria intervention trials in Africa, 1948 to 2007: a descriptive analysis

    OpenAIRE

    Gerritsen Annette; Lutje Vittoria; Siegfried Nandi

    2011-01-01

    Abstract Background Nine out of ten deaths from malaria occur in sub-Saharan Africa. Various control measures have achieved some progress in the control of the disease, but malaria is still a major public health problem in Africa. Randomized controlled trials (RCTs) are universally considered the best study type to rigorously assess whether an intervention is effective. The study reported here provides a descriptive analysis of RCTs reporting interventions for the prevention and treatment of ...

  8. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    OpenAIRE

    Young-Dae Kim; In Heo; Byung-Cheul Shin; Cindy Crawford; Hyung-Won Kang; Jung-Hwa Lim

    2013-01-01

    To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD) in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional th...

  9. 45 CFR 81.71 - Statement of position and trial briefs.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Statement of position and trial briefs. 81.71... trial briefs. The presiding officer may require parties and amici curiae to file written statements of... trial briefs....

  10. Clinical Trial Results Vary Widely, But Always Advance Research | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... of this page please turn Javascript on. Feature: Clinical Trials Clinical Trial Results Vary Widely, But Always Advance Research ... very emotional." Should You Be Interested in a Clinical Trial People volunteer to take part in clinical ...

  11. 77 FR 9947 - Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Science.gov (United States)

    2012-02-21

    ...Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information...Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information...Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control...

  12. 75 FR 63188 - Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Science.gov (United States)

    2010-10-14

    ...Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information...Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information...Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control...

  13. 76 FR 22404 - Analgesic Clinical Trials Innovation, Opportunities, and Networks (ACTION) Initiative

    Science.gov (United States)

    2011-04-21

    ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration...FDA-2011-N-0012] Analgesic Clinical Trials Innovation, Opportunities...support of the Analgesic Clinical Trials Innovation, Opportunities...slow down analgesic clinical trials and analgesic drug...

  14. 75 FR 9228 - Draft Guidance for Industry on Non-Inferiority Clinical Trials; Availability

    Science.gov (United States)

    2010-03-01

    ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration...on Non-Inferiority Clinical Trials; Availability AGENCY: Food...Non- Inferiority Clinical Trials.'' This draft guidance provides...Non-Inferiority Clinical Trials.'' The draft guidance...

  15. 78 FR 7437 - Proposed Collection; Comment Request (60-Day FRN); The Clinical Trials Reporting Program (CTRP...

    Science.gov (United States)

    2013-02-01

    ...DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes...60-Day FRN); The Clinical Trials Reporting Program (CTRP) Database...Proposed Collection: The Clinical Trials Reporting Program (CTRP) Database...Information Collection: The Clinical Trials Reporting Program (CTRP)...

  16. 77 FR 6808 - Proposed Collection; Comment Request: Information Program on Clinical Trials; Maintaining a...

    Science.gov (United States)

    2012-02-09

    ...Request: Information Program on Clinical Trials; Maintaining a Registry...projects, the National Library of Medicine (NLM), the National Institutes...Title: Information Program on Clinical Trials: Maintaining a Registry...which was established as a clinical trial registry under...

  17. 77 FR 22578 - Submission for OMB Review; Comment Request; Information Program on Clinical Trials: Maintaining a...

    Science.gov (United States)

    2012-04-16

    ...Request; Information Program on Clinical Trials: Maintaining a Registry...1995, the National Library of Medicine (NLM), the National Institutes...Title: Information Program on Clinical Trials: Maintaining a Registry...which was established as a clinical trial registry under...

  18. 76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

    Science.gov (United States)

    2011-08-19

    ...use as an endpoint in clinical trials.'' This draft...for Imaging Endpoints in Clinical Trials'' cosponsored...the Society of Nuclear Medicine, and the Radiological...practice standard and a clinical trial standard, and...

  19. Single-trial detection for intraoperative somatosensory evoked potentials monitoring.

    Science.gov (United States)

    Hu, L; Zhang, Z G; Liu, H T; Luk, K D K; Hu, Y

    2015-12-01

    Abnormalities of somatosensory evoked potentials (SEPs) provide effective evidence for impairment of the somatosensory system, so that SEPs have been widely used in both clinical diagnosis and intraoperative neurophysiological monitoring. However, due to their low signal-to-noise ratio (SNR), SEPs are generally measured using ensemble averaging across hundreds of trials, thus unavoidably producing a tardiness of SEPs to the potential damages caused by surgical maneuvers and a loss of dynamical information of cortical processing related to somatosensory inputs. Here, we aimed to enhance the SNR of single-trial SEPs using Kalman filtering and time-frequency multiple linear regression (TF-MLR) and measure their single-trial parameters, both in the time domain and in the time-frequency domain. We first showed that, Kalman filtering and TF-MLR can effectively capture the single-trial SEP responses and provide accurate estimates of single-trial SEP parameters in the time domain and time-frequency domain, respectively. Furthermore, we identified significant correlations between the stimulus intensity and a set of indicative single-trial SEP parameters, including the correlation coefficient (between each single-trial SEPs and their average), P37 amplitude, N45 amplitude, P37-N45 amplitude, and phase value (at the zero-crossing points between P37 and N45). Finally, based on each indicative single-trial SEP parameter, we investigated the minimum number of trials required on a single-trial basis to suggest the existence of SEP responses, thus providing important information for fast SEP extraction in intraoperative monitoring. PMID:26557929

  20. Trial design issues and treatment effect modeling in multi-regional schizophrenia trials.

    Science.gov (United States)

    Chen, Yeh-Fong; Wang, Sue-Jane; Khin, Ni A; Hung, H M James; Laughren, Thomas P

    2010-01-01

    In recent years, we have seen an increasing trend of foreign data as part of clinical trial data submitted in new drug class="hlt">applications (NDA) to US Food and Drug Administration (FDA). To understand the design and analysis characteristics, we studied schizophrenia multi-regional clinical trials (MRCTs). The schizophrenia data set consisted of a total of 12,585 patients collected from 33 clinical trials with 63.8% patients from North America, the largest region. The data set constituted 10 schizophrenia drug programs in support of NDAs submitted to FDA from December 1993 to December 2005. Two main objectives were pursued. First, we investigated some study design issues including potential heterogeneity of treatment effect via meta analysis and placebo response pattern over time. Second, we performed empirical modeling in two ways, supervised and unsupervised, to explain potential impact of baseline covariates on treatment effect in MRCTs. Based on our analysis results, placebo response appeared to increase over time and primarily attributed to US region. On average, the observed treatment effect in the US was generally smaller than non-US region. Both supervised and unsupervised empirical modeling selected baseline Positive and Negative Syndrome Scale total score as one of the most important covariates explaining a treatment effect. Region also played a role in explaining potential treatment effect heterogeneity. When baseline body weight was considered as a covariate in an empiric model, our results indicated that it alone did not seem to be an important factor in explaining regional difference. PMID:20872622

  1. Comparing community and specialty provider-based recruitment in a randomized clinical trial: clinical trial in fecal incontinence

    Science.gov (United States)

    Recruitment of participants to clinical trials remains a significant challenge, especially for research addressing topics of a sensitive nature such as fecal incontinence (FI). The Fiber Study, a randomized controlled trial on symptom management for FI, successfully enrolled 189 community-living adu...

  2. Effects of a Stimulus Prompt Display on Therapists' Accuracy, Rate, and Variation of Trial Type Delivery during Discrete Trial Teaching

    Science.gov (United States)

    May, Richard J.; Austin, Jennifer L.; Dymond, Simon

    2011-01-01

    Research on training therapists to deliver discrete trial teaching (DTT) has tended to focus on a limited range of therapist competencies and may have neglected important variables such as the rate and variation of trial types delivered across complete teaching sessions. Stimulus prompting procedures may facilitate the delivery of DTT for the…

  3. The Ecologic Validity of Fructose Feeding Trials: Supraphysiological Feeding of Fructose in Human Trials Requires Careful Consideration When Drawing Conclusions on Cardiometabolic Risk

    OpenAIRE

    Choo, Vivian L.; John L. Sievenpiper

    2015-01-01

    Background Select trials of fructose overfeeding have been used to implicate fructose as a driver of cardiometabolic risk. Objective We examined temporal trends of fructose dose in human controlled feeding trials of fructose and cardiometabolic risk. Methods We combined studies from eight meta-analyses on fructose and cardiometabolic risk to assess the average fructose dose used in these trials. Two types of trials were identified: (1) substitution trials, in which energy f...

  4. Efficacy of fish intake on vitamin D status : a meta-analysis of randomized controlled trials

    DEFF Research Database (Denmark)

    Lehmann, Ulrike; Gjessing, Hanne Rosendahl

    2015-01-01

    BACKGROUND: It is well known that fish is the major natural source of vitamin D in the diet; therefore, this meta-analysis investigated the influence of fish consumption in randomized controlled trials (RCTs) on serum 25-hydroxyvitamin D [25(OH)D] concentrations. OBJECTIVE: A literature search was carried out in Medline, Embase, Web of Science, and the Cochrane Library (up to February 2014) for RCTs that investigated the effect of fish consumption on 25(OH)D concentrations in comparison to other dietary interventions. RESULTS: Seven articles and 2 unpublished study data sets with 640 subjects and 14 study groups met the inclusion criteria and were included in this meta-analysis. Compared with controls, the consumption of fish increased 25(OH)D concentrations, on average, by 4.4 nmol/L (95% CI: 1.7, 7.1 nmol/L; P < 0.0001, I(2) = 25%; 9 studies).The type of the fish also played a key role: the consumption of fatty fish resulted in a mean difference of 6.8 nmol/L (95% CI: 3.7, 9.9 nmol/L; P < 0.0001, I(2) = 0%; 7 study groups), whereas for lean fish the mean difference was 1.9 nmol/L (95% CI: -2.3, 6.0 nmol/L; P < 0.38, I(2) = 37%; 7 study groups). Short-term studies (4-8 wk) showed a mean difference of 3.8 nmol/L (95% CI: 0.6, 6.9 nmol/L; P < 0.02, I(2) = 38%; 10 study groups), whereas in long-term studies (?6 mo) the mean difference was 8.3 nmol/L (95% CI: 2.1, 14.5 nmol/L; P < 0.009, I(2) = 0%; 4 study groups). CONCLUSION: As the major food source of vitamin D, fish consumption increases concentrations of 25(OH)D, although recommended fish intakes cannot optimize vitamin D status.

  5. Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gregson Barbara A

    2012-10-01

    Full Text Available Abstract Background Intracranial hemorrhage occurs in over 60% of severe head injuries in one of three types: extradural (EDH; subdural (SDH; and intraparenchymal (TICH. Prompt surgical removal of significant SDH and EDH is established and widely accepted. However, TICH is more common and is found in more than 40% of severe head injuries. It is associated with a worse outcome but the role for surgical removal remains undefined. Surgical practice in the treatment of TICHs differs widely around the world. The aim of early surgery in TICH removal is to prevent secondary brain injury. There have been trials of surgery for spontaneous ICH (including the STICH II trial, but none so far of surgery for TICH. Methods/Design The UK National Institutes of Health Research has funded STITCH(Trauma to determine whether a policy of early surgery in patients with TICH improves outcome compared to a policy of initial conservative treatment. It will include a health economics component and carry out a subgroup analysis of patients undergoing invasive monitoring. This is an international multicenter pragmatic randomized controlled trial. Patients are eligible if: they are within 48 h of injury; they have evidence of TICH on CT scan with a confluent volume of attenuation significantly raised above that of the background white and grey matter that has a total volume >10 mL; and their treating neurosurgeon is in equipoise. Patients will be ineligible if they have: a significant surface hematoma (EDH or SDH requiring surgery; a hemorrhage/contusion located in the cerebellum; three or more separate hematomas fulfilling inclusion criteria; or severe pre-existing physical or mental disability or severe co-morbidity which would lead to poor outcome even if the patient made a full recovery from the head injury. Patients will be randomized via an independent service. Patients randomized to surgery receive surgery within 12 h. Both groups will be monitored according to standard neurosurgical practice. All patients have a CT scan at 5 days (+/?2 days to assess changes in hematoma size. Follow-up is by postal questionnaire at 6 and 12 months. The recruitment target is 840 patients. Trial registration Current Controlled Trials ISRCTN19321911

  6. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ?45?years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared to subjects treated in the control group. Outcomes The primary outcome is the Alzheimer’s Disease Cooperative Studies Group Activities of Daily Living Scale; secondary outcome measures are two performance-based measures including the Short Physical Performance Battery and Short Portable Sarcopenia Measure. Outcome assessments for both the caregiver-reported scale and subjects’ physical performance scales are completed in the subject’s home. Randomization Eligible patient-care giver dyads will be stratified by clinic type and block randomized with a computer developed randomization scheme using a 1:1 allocation ratio. Blinding Single blinded. Research assistants completing the outcome assessments were blinded to the subjects’ treatment group. Trial status Ongoing ClinicalTrial.Gov identifier NCT01314950; date of completed registration 10 March 2011; date first patient randomized 9 March 2011

  7. Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation (NONSEDA Trial) : study protocol for a randomised controlled trial

    DEFF Research Database (Denmark)

    Toft, Palle; Olsen, Hanne Tanghus

    2014-01-01

    BACKGROUND: Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level. No randomised trial has been conducted comparing sedation with no sedation, a priori powered to have all-cause mortality as primary outcome.The objective is to assess the benefits and harms of non-sedation versus sedation with a daily wake-up trial in critically ill patients. METHODS: The non-sedation (NONSEDA) trial is an investigator-initiated, randomised, clinical, parallel-group, multinational trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden.Inclusion criteria are mechanically ventilated patients with expected duration of mechanical ventilation >24 hours.Exclusion criteria are non-intubated patients, patients with severe head trauma, coma at admission or status epilepticus, patients treated with therapeutic hypothermia, patients with PaO2/FiO2 < 9 where sedation might be necessary to ensure sufficient oxygenation or place the patient in prone position.Experimental intervention is non-sedation supplemented with pain management during mechanical ventilation.Control intervention is sedation with a daily wake-up trial.The primary outcome will be all cause mortality at 90 days after randomization. Secondary outcomes will be: days until death throughout the total observation period; coma- and delirium-free days; highest RIFLE score; days until discharge from the intensive care unit (within 28 days); days until the participant is without mechanical ventilation (within 28 days); and proportion of patients with a major cardiovascular outcome. Explorative outcomes will be: all cause mortality at 28 days after randomisation; days until discharge from the intensive care unit; days until the participant is without mechanical ventilation; days until discharge from the hospital; organ failure.Trial size: we will include 700 participants (2 x 350) in order to detect or reject 25% relative risk reduction in mortality with a type I error risk of 5% and a type II error risk of 20% (power at 80%). DISCUSSION: The trial investigates potential benefits of non-sedation. This might have large impact on the future treatment of mechanically ventilated critically ill patients.Trial register: ClinicalTrials.gov NCT0196768, 09.01.2014.

  8. Effects of Oral Vitamin C Supplementation on Anxiety in Students: A Double-Blind, Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    de Oliveira, Ivaldo Jesus Lima; de Souza, Victor Vasconcelos; Motta, Vitor; Da-Silva, Sérgio Leme

    2015-01-01

    Vitamin C ascorbic acid) is a well-known antioxidant that is involved in anxiety, stress, depression, fatigue and mood state in humans. Studies have suggested that oxidative stress may trigger neuropsychological disorders. Antioxidants may play an important therapeutic role in combating the damage caused by oxidative stress in individuals that suffer from anxiety. In this context, it was hypothesized that oral vitamin C supplementation would reduce anxiety. However, few up to date studies have evaluated the consequences of oral vitamin C supplementation on anxiety in humans. The present study examined the effects of oral vitamin C supplements in 42 high school students, in a randomized, double-blind, placebo-controlled trial. The students were given either vitamin C (500 mg day(-1)) or placebo. Plasma concentrations of vitamin C and blood pressure were measured before the intervention and then one day after the intervention. Anxiety levels were evaluated for each student before and after 14 days following supplementation with the Beck Anxiety Inventory. Results showed that vitamin C reduced anxiety levels and led to higher plasma vitamin C concentration compared to the placebo. The mean heart rates were also significantly different between vitamin C group and placebo control group. Present study results not only provide evidence that vitamin C plays an important therapeutic role for anxiety but also point a possible use for antioxidants in the prevention or reduction of anxiety. This suggests that a diet rich in vitamin C may be an effective adjunct to medical and psychological treatment of anxiety and improve academic performance. PMID:26353411

  9. Effects of Oral Vitamin C Supplementation on Anxiety in Students: A Double-Blind, Randomized, Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Ivaldo Jesus Lima de Oliveira

    2015-01-01

    Full Text Available Vitamin C (ascorbic acid is a well-known antioxidant that is involved in anxiety, stress, depression, fatigue and mood state in humans. Studies have suggested that oxidative stress may trigger neuropsychological disorders. Antioxidants may play an important therapeutic role in combating the damage caused by oxidative stress in individuals that suffer from anxiety. In this context, it was hypothesized that oral vitamin C supplementation would reduce anxiety. However, few up to date studies have evaluated the consequences of oral vitamin C supplementation on anxiety in humans. The present study examined the effects of oral vitamin C supplements in 42 high school students, in a randomized, double-blind, placebo-controlled trial. The students were given either vitamin C (500 mg day-1 or placebo. Plasma concentrations of vitamin C and blood pressure were measured before the intervention and then one day after the intervention. Anxiety levels were evaluated for each student before and after 14 days following supplementation with the Beck Anxiety Inventory. Results showed that vitamin C reduced anxiety levels and led to higher plasma vitamin C concentration compared to the placebo. The mean heart rates were also significantly different between vitamin C group and placebo control group. Present study results not only provide evidence that vitamin C plays an important therapeutic role for anxiety but also point a possible use for antioxidants in the prevention or reduction of anxiety. This suggests that a diet rich in vitamin C may be an effective adjunct to medical and psychological treatment of anxiety and improve academic performance.

  10. Scientific Opinion on field trials for bovine tuberculosis vaccination

    Directory of Open Access Journals (Sweden)

    EFSA Panel on Animal Health and Welfare (AHAW

    2013-12-01

    Full Text Available The opinion provides advice relating to the design of field trials to test the performance of a vaccine for bovine tuberculosis (bTB, along with a test to Detect Infected among Vaccinated Animals (DIVA. The objective of cattle vaccination is to use the vaccine in combination with presently applied control measures within the EU as an aid towards bTB eradication. The ideal field trials for the DIVA test will follow the OIE guidelines for test validation. Any deviations from the ideal trial design in relation to DIVA test performance should be justified, and the bias that may subsequently be introduced should be accounted for. The ideal field trial design for vaccination performance should implement a double-blind randomised test scenario, and allow for known risk factors in the field situation. Any deviations from the ideal trial design in relation to vaccine performance should also be justified and bias that may subsequently be introduced should be accounted for. Relevant risk factors and possible confounders that should be taken into consideration in the design of field trials are described in this opinion. The safety of a candidate vaccine is guaranteed in the registration of a vaccine medication by a competent authority. The field trials will need to fulfil these requirements to prove that the use of this vaccine in the field is safe for both public health and the environment. Some additional remarks regarding the safety of this specific vaccine are included in this opinion.

  11. Pharmacologically active: Clinical trials and the pharmaceutical industry

    Scientific Electronic Library Online (English)

    Michael, Kahn; Michael, Gastrow.

    2008-02-01

    Full Text Available Multinational pharmaceutical companies ('pharmas') import and produce pharmaceuticals and also conduct clinical trials which are an important aspect of research and development (R&D). This may raise the question: Is South Africa a guinea pig for the pharmas? The Department of Trade and Industry Nati [...] onal Industrial Policy Framework¹ designates chemicals, plastic fabrication and pharmaceuticals as a key value chain. So a second question could be: Can South Africa be a manufacturer for the pharmas, or can it leverage strengths in medical research and the conducting of clinical trials so as to develop a discovery-led industry? This paper analyses and quantifies the state of the clinical trials industry in South Africa, and concludes that: (i) a sizeable clinical trials industry exists, and that these trials are predominantly phase 3 and global in scope; (ii) South Africa is not a specific or unique guinea pig - a range of conditions is studied as part of global trials; and (iii) while South Africa has excellent prospects for increased clinical trials activity, R&D investment is too low to make it a major pharmaceutical contender.

  12. An evaluation of the results of neutron therapy trials

    International Nuclear Information System (INIS)

    Twenty-five randomised clinical trials have been completed which have investigated the value of fast neutron therapy. The results of these trials are reviewed in terms of the reported rates of local tumour control and late morbidity. The trials have included patients with cancers of the head and neck region, brain, lung, pancreas, cervix, bladder and rectum. None has demonstrated neutrons to be advantageous compared with photons. Two trials of locally advanced prostate cancer have given conflicting results. A trial of mixed schedule therapy has demonstrated improved local tumour control and survival. A trial of neutrons alone for similar stage disease has not shown any therapeutic advantages. It is still claimed that salivary gland tumours may be more effectively treated by neutrons but the clinical trial results are not definitive. Late morbidity after neutron therapy is a persistent cause for concern and often has been unacceptably high. There is no convincing evidence that fast neutrons are either as safe or as effective in cancer control as photon therapy. (orig.)

  13. Construction of ethics in clinical research: clinical trials registration

    Scientific Electronic Library Online (English)

    C. A., Caramori.

    Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceut [...] ical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong conclusions) led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE), supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO) created the International Clinical Trial Registry Platform (ICTRP), which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

  14. Does Milk Cause Constipation? A Crossover Dietary Trial

    Directory of Open Access Journals (Sweden)

    Peter D. Jones

    2013-01-01

    Full Text Available The aims of this study were to: (1 determine whether replacement of cow’s milk protein with soy resolves Chronic Functional Constipation (CFC; and (2 investigate the effects of cow’s milk ? casein A1 and cow’s milk ? casein A2 on CFC. Children diagnosed with CFC were recruited to one of two crossover trials: Trial 1 compared the effects of cow’s milk and soy milk; Trial 2 compared the effects of cow’s milk ? casein A1 and cow’s milk ? casein A2. Resolution of constipation was defined as greater than eight bowel motions during a two week intervention. Thirteen children (18 to 144 months participated in Trial 1 (6 boys, 7 girls. Nine participants who completed the soy epoch all experienced resolution (p < 0.05. Thirty-nine children (21 to 144 months participated in Trial 2 (25 boys, 14 girls. Resolution of constipation was highest during the washout epoch, 81%; followed by cow’s milk ? casein A2, 79%; and cow’s milk ? casein A1, 57%; however, the proportions did not differ statistically. The results of Trial 1 demonstrate an association between CFC and cow’s milk consumption but Trial 2 failed to show an effect from type of casein. Some other component in cow’s milk common to both A1 and A2 milk may be causing a problem in these susceptible children.

  15. New clinical trials for nonmotor manifestations of Parkinson's disease.

    Science.gov (United States)

    Schrag, Anette; Sauerbier, Anna; Chaudhuri, Kallol Ray

    2015-09-15

    Nonmotor manifestations in Parkinson's disease (PD) encompass a range of clinical features, including neuropsychiatric problems, autonomic dysfunction, sleep disorders, fatigue, and pain. Despite their importance for patients' quality of life, the evidence base for their treatment is relatively sparse. Nevertheless, the last few years have seen a number of new trials starting that specifically address nonmotor features as an outcome measure in clinical trials. Large randomized, controlled trials in the last 3 years reported improvement of psychosis with the new selective serotonin 5-HT2A inverse agonist pimavanserin and of postural hypotension with the oral norepinephrine precursor droxidopa. Smaller new randomized, controlled trials support the effectiveness of Deep Brain Stimulation and opiates for pain, of rivastigmine for apathy and piribedil for apathy post-DBS, group cognitive behavioral therapy for depression and/or anxiety, continuous positive airway pressure for sleep apnea in PD and doxepin for insomnia, and of solifenacin succinate and transcutaneous tibial nerve stimulation for urinary symptoms. A number of new smaller or open trials as well as post-hoc analyses of randomized, controlled trials have suggested usefulness of other treatments, and new randomized, controlled trials are currently ongoing. © 2015 International Parkinson and Movement Disorder Society. PMID:26371623

  16. Motivation and frustration in cardiology trial participation: the patient perspective

    Scientific Electronic Library Online (English)

    Silmara, Meneguin; Luiz Antônio Machado, Cesar.

    Full Text Available OBJECTIVE: The participation of humans in clinical cardiology trials remains essential, but little is known regarding participant perceptions of such studies. We examined the factors that motivated participation in such studies, as well as those that led to participant frustration. METHODS: Patients [...] who had participated in hypertension and coronary arterial disease (phases II, III, and IV) clinical trials were invited to answer a questionnaire. They were divided into two groups: Group I, which included participants in placebo-controlled clinical trials after randomization, and Group II, which included participants in clinical trials in which the tested treatment was compared to another drug after randomization and in which a placebo was used in the washout period. RESULTS: Eighty patients (47 patients in Group I and 33 patients in Group II) with different socio-demographic characteristics were interviewed. Approximately 60% of the patients were motivated to participate in the trial with the expectation of personal benefit. Nine participants (11.2%) expressed the desire to withdraw, which was due to their perception of risk during the testing in the clinical trial (Group I) and to the necessity of repeated returns to the institution (Group II). However, the patients did not withdraw due to fear of termination of hospital treatment. CONCLUSIONS: Although this study had a small patient sample, the possibility of receiving a benefit from the new tested treatment was consistently reported as a motivation to participate in the trials.

  17. Motivation and frustration in cardiology trial participation: the patient perspective

    Directory of Open Access Journals (Sweden)

    Silmara Meneguin

    2012-01-01

    Full Text Available OBJECTIVE: The participation of humans in clinical cardiology trials remains essential, but little is known regarding participant perceptions of such studies. We examined the factors that motivated participation in such studies, as well as those that led to participant frustration. METHODS: Patients who had participated in hypertension and coronary arterial disease (phases II, III, and IV clinical trials were invited to answer a questionnaire. They were divided into two groups: Group I, which included participants in placebo-controlled clinical trials after randomization, and Group II, which included participants in clinical trials in which the tested treatment was compared to another drug after randomization and in which a placebo was used in the washout period. RESULTS: Eighty patients (47 patients in Group I and 33 patients in Group II with different socio-demographic characteristics were interviewed. Approximately 60% of the patients were motivated to participate in the trial with the expectation of personal benefit. Nine participants (11.2% expressed the desire to withdraw, which was due to their perception of risk during the testing in the clinical trial (Group I and to the necessity of repeated returns to the institution (Group II. However, the patients did not withdraw due to fear of termination of hospital treatment. CONCLUSIONS: Although this study had a small patient sample, the possibility of receiving a benefit from the new tested treatment was consistently reported as a motivation to participate in the trials.

  18. Construction of ethics in clinical research: clinical trials registration

    Directory of Open Access Journals (Sweden)

    C. A. Caramori

    2007-01-01

    Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

  19. Introduction to a generalized method for adaptive randomization in trials

    Directory of Open Access Journals (Sweden)

    Hoare Zoë SJ

    2013-01-01

    Full Text Available Abstract Background Ideally clinical trials should use some form of randomization for allocating participants to the treatment groups under trial. As an integral part of the process of assessing the effectiveness of these treatment groups, randomization performed well can reduce, if not eliminate, some forms of bias that can be evident in non-randomized trials. Given the vast set of possible randomization methods to choose from we demonstrate a method that incorporates many of the advantages of these other methods. Methods A step-by-step introduction of how to use the adaptive randomization algorithm for conducting a clinical trial is given. Results The implications, effects and capabilities of using the adaptive randomization algorithm are fully demonstrated and explained using simulated data and examples from actual trials. Conclusions This paper provides an introduction to a dynamic type of treatment allocation, which fulfills the CONSORT requirements of participants being randomly allocated whilst maintaining a level of control of the balances overall, within the stratification variables and within the strata simultaneously. Maintaining control of the imbalances within the groups is vital particularly if interim analyses are planned. Trial registration Current controlled trials ISRCTN17551624, ISRCTN37558856, ISRCTN97185214.

  20. Patients' Motivation about Clinical Trials: A Local Perspective from Turkey

    Directory of Open Access Journals (Sweden)

    Hakan TABAN

    2011-01-01

    Full Text Available Objective: To investigate attitudes concerning clinical trials amongst potential Turkish research participants.Patients and Methods: This is a survey of 504 Turkish patients who applied to 4 research and education hospitals in Istanbul, Turkey in March and April 2008. Attitudes and knowledge of the patients concerning clinical trials were measured.Results: Of the 504 patients, 62.3% were male and the mean ± SD age was 36.8±14.0 years. Most of the respondents (88.3% believed that the new drugs should not be used directly on human beings without being tested on human subjects and 52.2% thought that clinical trials were being performed in Turkey. 97.8% of the patients believed that new drugs should be developed, 71.4% specified that the new drugs should be tested on human subjects durring the research period, 84.5% mentioned that apart from clinical trials they could not use a drug that had never been tested on human beings. Only 28.6% of the respondents believed that clinical trials could be performed on healthy human subjects. The educational status was an affecting factor for the patients' attitudes toward clinical trials. Only 7 (1.4% patients in the survey participated in a clinical trial previously, but 33.7% of the survey group indicates that they may agree with participating in a clinical trial.Conclusion: This survey presents first and valuable information about Turkish patients' attitudes for clinical trials. The results of this survey provide an understanding of Turkish patients' motivations, and supply information concerning recruitment and retention strategies. (Marmara Medical Journal 2011;24:179-84

  1. REDUCED MUSCLE PAIN INTENSITY RATING DURING REPEATED CYCLING TRIALS

    Directory of Open Access Journals (Sweden)

    Frank E. Marino

    2004-06-01

    Full Text Available The purpose of this study was to investigate muscle pain intensity rating using a 10-point category-ratio pain intensity scale during self-paced cycling exercise within three trials. Eleven subjects (age 21.4 ± 2.6 years; VO2 peak 3.3 ± 0.9 L·min-1 performed a 60-min cycling trial on three occasions. During each trial subjects cycled at the utmost work intensity for 60-min. To simulate competitive training, 1-min maximal effort sprints were performed every 10-mins into the trial. Ambient temperature and relative humidity were set at 33 ± 0.7 oC and 63 ± 2.0%, respectively. During exercise, subjects ranked the muscle pain intensity at 5 min intervals and following each sprint effort. Simple main effects revealed that muscle pain intensity ratings were significantly lower in trial 3 compared with trial 1 at the 50 min [F = 4.5(2 30; p = 0.015, eta2 = 0.05], 55 min [F = 4.89(2, 30; p = 0.011; eta2 = 0.05], and 60 min [F = 3.6(2, 30; p = 0.034; eta2 = 0.04] time interval. Repeated measures ANOVA revealed a significant increase in the mean distance cycled amongst the trials (p < 0001. These results indicate an attenuation in muscle pain intensity rating with endurance exercise training when performed over three trials. The reduced pain intensity rating may be due to adjustments in cadence and gear selection amongst the trials.

  2. Consumer input into research: the Australian Cancer Trials website

    Directory of Open Access Journals (Sweden)

    Butow Phyllis N

    2011-06-01

    Full Text Available Abstract Background The Australian Cancer Trials website (ACTO was publicly launched in 2010 to help people search for cancer clinical trials recruiting in Australia, provide information about clinical trials and assist with doctor-patient communication about trials. We describe consumer involvement in the design and development of ACTO and report our preliminary patient evaluation of the website. Methods Consumers, led by Cancer Voices NSW, provided the impetus to develop the website. Consumer representative groups were consulted by the research team during the design and development of ACTO which combines a search engine, trial details, general information about trial participation and question prompt lists. Website use was analysed. A patient evaluation questionnaire was completed at one hospital, one week after exposure to the website. Results ACTO's main features and content reflect consumer input. In February 2011, it covered 1, 042 cancer trials. Since ACTO's public launch in November 2010, until the end of February 2011, the website has had 2, 549 new visits and generated 17, 833 page views. In a sub-study of 47 patient users, 89% found the website helpful for learning about clinical trials and all respondents thought patients should have access to ACTO. Conclusions The development of ACTO is an example of consumers working with doctors, researchers and policy makers to improve the information available to people whose lives are affected by cancer and to help them participate in their treatment decisions, including consideration of clinical trial enrolment. Consumer input has ensured that the website is informative, targets consumer priorities and is user-friendly. ACTO serves as a model for other health conditions.

  3. The GUSTO trial and the open artery theory.

    Science.gov (United States)

    Califf, R M

    1997-12-01

    The GUSTO trials have provided continuing insight into the complexities of a simple fundamental relationship: early and sustained coronary perfusion in patients with acute myocardial infarction leads to lower mortality and morbidity. To a large extent, the GUSTO trials have attempted to develop approaches to therapy that will ensure the highest early rate of reperfusion with the least risk. A table provides a summary of the completed trials and those that are planned in attempts to provide further knowledge in the continuing quest to improve the plight of patients with acute myocardial infarction. PMID:9447334

  4. Does Milk Cause Constipation? A Crossover Dietary Trial

    OpenAIRE

    Jones, Peter D.; Roberts, Tim K; Dunstan, Richard H.; Crowley, Elesa T.; Williams, Lauren T

    2013-01-01

    The aims of this study were to: (1) determine whether replacement of cow’s milk protein with soy resolves Chronic Functional Constipation (CFC); and (2) investigate the effects of cow’s milk ? casein A1 and cow’s milk ? casein A2 on CFC. Children diagnosed with CFC were recruited to one of two crossover trials: Trial 1 compared the effects of cow’s milk and soy milk; Trial 2 compared the effects of cow’s milk ? casein A1 and cow’s milk ? casein A2. Resolution of constipation was defined as gr...

  5. Access to medications and conducting clinical trials in LMICs.

    Science.gov (United States)

    Okpechi, Ikechi G; Swanepoel, Charles R; Venter, Francois

    2015-03-01

    Access to essential medications is limited in many low-to-middle income countries (LMICs) and those that are available may be prohibitively expensive to the general population. Clinical trials have been suggested as an approach to improve drug access in LMICs but the number of trials conducted in these countries is small because of regulatory issues and a lack of infrastructure. In this article, Nature Reviews Nephrology asks three experts their opinions on how to improve drug access and increase the numbers of clinical trials conducted in LMICs. PMID:25668002

  6. European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE: A randomised control trial

    Directory of Open Access Journals (Sweden)

    Billingham Lucinda

    2008-09-01

    Full Text Available Abstract Background Renal failure is a frequent complication of multiple myeloma and when severe is associated with a greatly increased morbidity and mortality. The principal cause of severe renal failure is cast nephropathy, a direct consequence of high concentrations of monoclonal free light chains (FLCs in patients' sera. FLC removal by extended haemodialysis, using a high cut-off dialyser, has recently been described as a novel therapeutic option. Methods The EUropean trial of free LIght chain removal by exTEnded haemodialysis in cast nephropathy (EuLITE trial is a prospective, randomised, multicentre, open label clinical trial to investigate the clinical benefits of FLC removal haemodialysis in patients with cast nephropathy, dialysis dependent acute renal failure and de novo multiple myeloma. Recruitment commenced in May 2008. In total, 90 patients will be recruited. Participants will be randomised, centrally, upon enrolment, to either trial chemotherapy and FLC removal haemodialysis or trial chemotherapy and standard high flux haemodialysis. Trial chemotherapy consists of bortezomib, doxorubicin and dexamethasone. FLC removal haemodialysis is undertaken with two Gambro HCO 1100 dialysers in series using an intensive treatment schedule. The primary outcome for the study is independence of dialysis at 3 months. Secondary outcomes are: duration of dialysis, reduction in serum FLC concentrations; myeloma response and survival. Hypothesis FLC removal haemodialysis will increase the rate of renal recovery in patients with severe renal failure secondary to cast nephropathy in de novo multiple myeloma. Trial registration ISRCTN45967602

  7. Attitudes and perceptions of AIDS clinical trials group site coordinators on HIV clinical trial recruitment and retention: a descriptive study.

    Science.gov (United States)

    King, William D; Defreitas, Donna; Smith, Kimberly; Andersen, Janet; Perry, Lisa Patton; Adeyemi, Toyin; Mitty, Jennifer; Fritsche, Jan; Jeffries, Carrie; Littles, Melvin; Fischl, Margaret; Pavlov, Gregory; Mildvan, Donna

    2007-08-01

    HIV-seropositive blacks, Hispanics, women of all ethnicities, and injection drug users (IDUs) have low rates of clinical trial participation. The opinions of research nurses and study coordinators as potential facilitators and barriers to access to clinical trials may contribute to this disparity. Study coordinators and research nurses from the adult AIDS Clinical Trials Group (ACTG) clinical trials units responded to an anonymous computer-based survey comprising multiple choice questions and clinical scenarios. Descriptive statistics were used to determine frequencies of responses. Recruitment rates of blacks, Hispanics, women and IDUs were mostly rated appropriate compared with the geographic region demographics. Most sites ranked white men as being the most interested in clinical trials. Sites rated their most effective interactions were with white men. Respondents felt they were less likely to enroll individuals who had missed previous clinical appointments or did not speak English. Perceptions that IDUs, Hispanics, blacks, and, to a lesser extent, women had less interest in clinical trials participation than white males may affect recruitment of the targeted populations. Interventions to improve interactions with targeted populations and to remove logistical and language barriers may improve the diversity of clinical trial participants. PMID:17711380

  8. Personalized radiotherapy: concepts, biomarkers and trial design.

    Science.gov (United States)

    Ree, A H; Redalen, K R

    2015-07-01

    In the past decade, and pointing onwards to the immediate future, clinical radiotherapy has undergone considerable developments, essentially including technological advances to sculpt radiation delivery, the demonstration of the benefit of adding concomitant cytotoxic agents to radiotherapy for a range of tumour types and, intriguingly, the increasing integration of targeted therapeutics for biological optimization of radiation effects. Recent molecular and imaging insights into radiobiology will provide a unique opportunity for rational patient treatment, enabling the parallel design of next-generation trials that formally examine the therapeutic outcome of adding targeted drugs to radiation, together with the critically important assessment of radiation volume and dose-limiting treatment toxicities. In considering the use of systemic agents with presumed radiosensitizing activity, this may also include the identification of molecular, metabolic and imaging markers of treatment response and tolerability, and will need particular attention on patient eligibility. In addition to providing an overview of clinical biomarker studies relevant for personalized radiotherapy, this communication will highlight principles in addressing clinical evaluation of combined-modality-targeted therapeutics and radiation. The increasing number of translational studies that bridge large-scale omics sciences with quality-assured phenomics end points-given the imperative development of open-source data repositories to allow investigators the access to the complex data sets-will enable radiation oncology to continue to position itself with the highest level of evidence within existing clinical practice. PMID:25989697

  9. Decision-Making Trial and Evaluation Laboratory

    Directory of Open Access Journals (Sweden)

    Elham Falatoonitoosi

    2013-04-01

    Full Text Available The aim of this study is introducing a technique to illuminate composite issue, aspects or system factors, the complicated problems need to be structured with graphical illustration and analyzed casual interdependence and influences throughout the organization. Decision-Making Trial and Evaluation Laboratory (DEMATEL methodology is proposed to for researching and solving complex and intertwined problem groups because of its capability in verifying interdependence between variables and try to improve them by offering a specific chart to reflect interrelationships between variables. In this technique experts plays complementary and approval role in all steps and sections. , key factors will be clarified by using the direct-influenced matrix and then it specifies priorities of each factor. The end product of the DEMATEL process is a visual demonstration-the Impact-Relations Map (IRM-by which respondents organize their own actions in the world. First In this study, DEMATEL methodology in explained and then kind of different problems which can be solved by DEMATEL, will discussed and finally the method of DEMATEL is detailed completely.

  10. Imaging in early phase childhood cancer trials

    Energy Technology Data Exchange (ETDEWEB)

    Adamson, Peter C. [Children' s Hospital of Philadelphia, Division of Clinical Pharmacology and Therapeutics, Philadelphia, PA (United States)

    2009-02-15

    Advances made in the treatment of childhood malignancies during the last four decades have resulted in overall cure rates of approximately 80%, but progress has slowed significantly during the last 10 years, underscoring the need for more effective and less toxic agents. Current research is focused on development of molecularly targeted agents, an era ushered in with the discovery of imatinib mesylate for the treatment of chronic myelogenous leukemia. Since imatinib's introduction into the clinic, an increasing number of tyrosine kinase inhibitors have been developed and entered into clinical trials and practice. Parallel to the initial advances made in molecularly targeted agents has been the development of a spectrum of novel imaging modalities. Future goals for imaging in childhood cancer research thus include (1) patient identification based on target identification or other biologic characteristics of the tumor, (2) assessing pharmacokinetic-pharmacodynamic (PK-PD) effects, and (3) predictive value with an early indication of patient benefit. Development and application of novel imaging modalities for children with cancer can serve to streamline development of molecularly targeted agents. (orig.)

  11. Imaging in early phase childhood cancer trials

    International Nuclear Information System (INIS)

    Advances made in the treatment of childhood malignancies during the last four decades have resulted in overall cure rates of approximately 80%, but progress has slowed significantly during the last 10 years, underscoring the need for more effective and less toxic agents. Current research is focused on development of molecularly targeted agents, an era ushered in with the discovery of imatinib mesylate for the treatment of chronic myelogenous leukemia. Since imatinib's introduction into the clinic, an increasing number of tyrosine kinase inhibitors have been developed and entered into clinical trials and practice. Parallel to the initial advances made in molecularly targeted agents has been the development of a spectrum of novel imaging modalities. Future goals for imaging in childhood cancer research thus include (1) patient identification based on target identification or other biologic characteristics of the tumor, (2) assessing pharmacokinetic-pharmacodynamic (PK-PD) effects, and (3) predictive value with an early indication of patient benefit. Development and application of novel imaging modalities for children with cancer can serve to streamline development of molecularly targeted agents. (orig.)

  12. Hypertrophic cardiomyopathy: The need for randomized trials.

    Science.gov (United States)

    Olivotto, Iacopo; Tomberli, Benedetta; Spoladore, Roberto; Mugelli, Alessandro; Cecchi, Franco; Camici, Paolo G

    2013-01-01

    Hypertrophic cardiomyopathy (HCM) is a complex cardiac condition characterized by variable degrees of asymmetric left ventricular (LV) hypertrophy, generally associated with mutations in sarcomere protein genes. While generally perceived as rare, HCM is the most common genetic heart disease with over one million affected individuals in Europe alone and represents a prevalent cause of sudden cardiac death in the young. To date, HCM remains an orphan disease, as recommended treatment strategies are based on the empirical use of old drugs with little evidence supporting their clinical benefit in this context. In the six decades since the original description of the disease, less than fifty pharmacological studies have been performed in HCM patients, enrolling little over 2,000 HCM patients, mostly comprising small non-randomized cohorts. No specific agent has been convincingly shown to affect outcome, and critical issues such as prevention of myocardial energy depletion, microvascular ischemia, progressive myocardial fibrosis and the peculiar mechanisms of arrhythmogenesis in HCM still need to be addressed in a systematic fashion. However, there is increasing evidence that a variety of drugs may counter the effects of sarcomere protein mutations and the resulting pathophysiological abnormalities at the molecular, cellular and organ level. Following major advances in our understanding of HCM and increasing opportunities for networking among large international referral centres, the opportunity now exists to identify potentially effective treatments and implement adequately designed pharmacological trials, with the ultimate aim to impact the natural course of the disease, alleviate symptoms and improve quality of life in our patients. PMID:24689025

  13. The effects of radiation therapy on quality of life in women with breast cancer: Results of a randomized trial

    International Nuclear Information System (INIS)

    Purpose/Objective: The effects of radiation therapy on quality of life of women with breast cancer are not well known. The purpose of this study was to evaluate the effect of breast irradiation on quality of life including cosmetic outcome in the context of a randomized controlled trial. Methods: Between 1984 and 1989 a randomized trial was conducted in Ontario in which women with node-negative breast cancer who had undergone lumpectomy and axillary section were randomized either to postoperative radiation (4000 cGy in 16 fractions to the whole breast, followed by a boost of 1250 cGy in five fractions to the primary site) or no further treatment (J Natl Cancer Inst 1996; 88:1659). A modified version of the breast cancer chemotherapy questionnaire (J Clin Oncol 1988; 6:1798) containing 17 items was administered to women at baseline, one month and two months postrandomization. Each item was scored on a Likert scale from ''1'' All of the Time to ''7'' None of the Time. Patient assessments of breast pain and cosmetic outcome were also evaluated every three months for the first two years of the study. Results: Of 837 patients, 416 were randomly allocated to radiation therapy and 421 to no further treatment. The groups were comparable in terms of baseline characteristics. Factor analysis identified three different domains of the quality of life instrument: emotional/social, fatigue, and physical/inconvenience. There was a significant difference in the physical/inconvenience and fatigue domain scores between the radiation and control groups over time. The differences in scores between groups at two months post randomization were 0.97, p = 0.0001; 0.33, p=0.0001; and 0.03, p=0.62 for the physical/inconvenience, fatigue and emotional/social domains respectively. The percentage of patients who were troubled by breast pain differed between radiation and control groups up to one year (33.3% vs 19.9%, p = 0.001 at 6 months). Beyond one year, no difference was detected. The percent of patients who were troubled by the appearance of their breast did not differ between the two groups (4.8% vs 4.8%, p = 0.97 at 2 years). Conclusion: Results indicate that while radiation increased patients' fatigue and other physical symptoms including inconvenience, it did not have a major impact on other parameters of quality of life. Radiation did increase breast pain in the first year, but longer term, no difference was detected in pain or cosmetic outcome as perceived by patients

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

    Directory of Open Access Journals (Sweden)

    Schlitt Hans

    2010-04-01

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

  15. Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials.

    Science.gov (United States)

    Riaz, Haris; Raza, Sajjad; Khan, Muhammad Shahzeb; Riaz, Irbaz Bin; Krasuski, Richard A

    2015-12-15

    Previous authors have suggested a higher likelihood for industry-sponsored (IS) studies to have positive outcomes than non-IS studies, though the influence of publication bias was believed to be a likely confounder. We attempted to control for the latter using a prepublication database to compare the primary outcome of recent trials based on sponsorship. We used the "advanced search" feature in the clinicaltrials.gov website to identify recently completed phase III studies involving the implementation of a pharmaceutical agent or device for which primary data were available. Studies were categorized as either National Institutes of Health (NIH) sponsored or IS. Results were labeled "favorable" if the results favored the intervention under investigation or "unfavorable" if the intervention fared worse than standard medical treatment. We also performed an independent literature search to identify the cardiovascular trials as a case example and again categorized them into IS versus NIH sponsored. A total of 226 studies sponsored by NIH were found. When these were compared with the latest 226 IS studies, it was found that IS studies were almost 4 times more likely to report a positive outcome (odds ratio [OR] 3.90, 95% confidence interval [CI] 2.6087 to 5.9680, p <0.0001). As a case example of a specialty, we also identified 25 NIH-sponsored and 215 IS cardiovascular trials, with most focusing on hypertension therapy (31.6%) and anticoagulation (17.9%). IS studies were 7 times more likely to report favorable outcomes (OR 7.54, 95% CI 2.19 to 25.94, p = 0.0014). They were also considerably less likely to report unfavorable outcomes (OR 0.11, 95% CI 0.04 to 0.26, p <0.0001). In conclusion, the outcomes of large clinical studies especially cardiovascular differ considerably on the basis of their funding source, and publication bias appears to have limited influence on these findings. PMID:26611124

  16. The Depression in Visual Impairment Trial (DEPVIT: trial design and protocol

    Directory of Open Access Journals (Sweden)

    Margrain Tom H

    2012-07-01

    Full Text Available Abstract Background The prevalence of depression in people with a visual disability is high but screening for depression and referral for treatment is not yet an integral part of visual rehabilitation service provision. One reason for this may be that there is no good evidence about the effectiveness of treatments in this patient group. This study is the first to evaluate the effect of depression treatments on people with a visual impairment and co morbid depression. Methods /design The study is an exploratory, multicentre, individually randomised waiting list controlled trial. Participants will be randomised to receive Problem Solving Therapy (PST, a ‘referral to the GP’ requesting treatment according to the NICE’s ‘stepped care’ recommendations or the waiting list arm of the trial. The primary outcome measure is change (from randomisation in depressive symptoms as measured by the Beck’s Depression Inventory (BDI-II at 6?months. Secondary outcomes include change in depressive symptoms at 3?months, change in visual function as measured with the near vision subscale of the VFQ-48 and 7 item NEI-VFQ at 3 and 6?months, change in generic health related quality of life (EQ5D, the costs associated with PST, estimates of incremental cost effectiveness, and recruitment rate estimation. Discussion Depression is prevalent in people with disabling visual impairment. This exploratory study will establish depression screening and referral for treatment in visual rehabilitation clinics in the UK. It will be the first to explore the efficacy of PST and the effectiveness of NICE’s ‘stepped care’ approach to the treatment of depression in people with a visual impairment. Trial registration ISRCTN46824140

  17. The HAART cell phone adherence trial (WelTel Kenya1: a randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Ball T Blake

    2009-09-01

    Full Text Available Abstract Background The objectives are to compare the effectiveness of cell phone-supported SMS messaging to standard care on adherence, quality of life, retention, and mortality in a population receiving antiretroviral therapy (ART in Nairobi, Kenya. Methods and Design A multi-site randomized controlled open-label trial. A central randomization centre provided opaque envelopes to allocate treatments. Patients initiating ART at three comprehensive care clinics in Kenya will be randomized to receive either a structured weekly SMS ('short message system' or text message slogan (the intervention or current standard of care support mechanisms alone (the control. Our hypothesis is that using a structured mobile phone protocol to keep in touch with patients will improve adherence to ART and other patient outcomes. Participants are evaluated at baseline, and then at six and twelve months after initiating ART. The care providers keep a weekly study log of all phone based communications with study participants. Primary outcomes are self-reported adherence to ART and suppression of HIV viral load at twelve months scheduled follow-up. Secondary outcomes are improvements in health, quality of life, social and economic factors, and retention on ART. Primary analysis is by 'intention-to-treat'. Sensitivity analysis will be used to assess per-protocol effects. Analysis of covariates will be undertaken to determine factors that contribute or deter from expected and determined outcomes. Discussion This study protocol tests whether a novel structured mobile phone intervention can positively contribute to ART management in a resource-limited setting. Trial Registration Trial Registration Number: NCT00830622

  18. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial.

    LENUS (Irish Health Repository)

    French, Helen P

    2009-01-01

    Osteoarthritis (OA) of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT) found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy.

  19. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS trial: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wu Samuel S

    2007-11-01

    Full Text Available Abstract Background Locomotor training using body weight support and a treadmill as a therapeutic modality for rehabilitation of walking post-stroke is being rapidly adopted into clinical practice. There is an urgent need for a well-designed trial to determine the effectiveness of this intervention. The objective of the Locomotor Experience Applied Post-Stroke (LEAPS trial is to determine if there is a difference in the proportion of participants who recover walking ability at one year post-stroke when randomized to a specialized locomotor training program (LTP, conducted at 2- or 6-months post-stroke, or those randomized to a home based non-specific, low intensity exercise intervention (HEP provided 2 months post-stroke. We will determine if the timing of LTP delivery affects gait speed at 1 year and whether initial impairment severity interacts with the timing of LTP. The effect of number of treatment sessions will be determined by changes in gait speed taken pre-treatment and post-12, -24, and -36 sessions. Methods/Design We will recruit 400 adults with moderate or severe walking limitations within 30 days of stroke onset. At two months post stroke, participants are stratified by locomotor impairment severity as determined by overground walking speed and randomly assigned to one of three groups: (a LTP-Early; (b LTP-Late or (c Home Exercise Program -Early. The LTP program includes body weight support on a treadmill and overground training. The LTP and HEP interventions are delivered for 36 sessions over 12 weeks. Primary outcome measure include successful walking recovery defined as the achievement of a 0.4 m/s gait speed or greater by persons with initial severe gait impairment or the achievement of a 0.8 m/s gait speed or greater by persons with initial moderate gait impairment. LEAPS is powered to detect a 20% difference in the proportion of participants achieving successful locomotor recovery between the LTP groups and the HEP group, and a 0.1 m/s mean difference in gait speed change between the two LTP groups. Discussion The goal of this single-blinded, phase III randomized clinical trial is to provide evidence to guide post-stroke walking recovery programs. Trial registration NCT00243919.

  20. Early closure of temporary ileostomy--the EASY trial : protocol for a randomised controlled trial

    DEFF Research Database (Denmark)

    Danielsen, Anne Kjaergaard; Correa-Marinez, Adiela

    2011-01-01

    Objective The objective is to evaluate efficiency based on data on morbidity and mortality, health-related quality of life and healthcare-related costs after early reversal of temporary ileostomy after rectal resection for cancer compared with the standard procedure (late reversal). Background Reversal of a temporary ileostomy is generally associated with a low morbidity and mortality. However, ostomy reversal may cause complications requiring reoperation with subsequent major complications, in ranges from 0% to 7-9% and minor complications varying from 4-5% to 30%. Based on studies exploring and describing the time of closure in previous studies which are mostly of low quality, a recent review concluded that closing a temporary stoma within 2 weeks did not seem to be associated with an increase in morbidity and mortality. Design and methods Early closure of temporary ileostomy (EASY), a randomised controlled trial, is a prospective randomised controlled multicentre study which is performed within the framework of the Scandinavian Surgical Outcomes Research Group (http://www.ssorg.net/) and plans to include 200 patients from Danish and Swedish hospitals. The primary end-point of the study is the frequency of complications 0-12 months after surgery (the stoma creation operation). The secondary end-points of the study are (1) comparison of the total costs of the two groups at 6 and 12 months after surgery (stoma creation); (2) comparison of health-related quality of life in the two groups evaluated with the 36-item short-form and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29/CR30 at 3, 6 and 12 months after surgery (stoma creation); and (3) comparison of disease-specific quality of life in the two groups at 3, 6 and 12 months after surgery (stoma creation). Discussion The aim of the EASY trial is to evaluate the efficiency of early reversal of temporary ileostomy after surgery for rectal cancer versus late reversal. The EASY trial isexpected to have a huge impact on patient safety as well as an improvement in patient-reported outcome. Clinical trials identifier NCT01287637.

  1. Smoking Cessation Drug Proves Effective in Single-Center Trial

    Science.gov (United States)

    The smoking cessation drug cytisine was more effective than a placebo at helping participants abstain from smoking, according to results of a randomized controlled trial published in the September 29, 2011, issue of the New England Journal of Medicine.

  2. Trial Yields Positive Data on Pembrolizumab for Lung Cancer

    Science.gov (United States)

    Findings from an early phase clinical trial may point to a biomarker that identifies patients with advanced non-small cell lung cancer most likely to respond to the immunotherapy drug pembrolizumab (Keytruda®).

  3. Planning a Clinical Trial Checklist | accrualnet.cancer.gov

    Science.gov (United States)

    This checklist consists of a series of steps to consider when planning to open a clinical trial. Some of the steps are specific to the study site that developed the checklist but they may represent comparable processes at other institutions.

  4. Clinical Research Trials | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... version of this page please turn Javascript on. Clinical Research Trials Past Issues / Summer 2012 Table of Contents Let the Opportunities to Join A Clinical Study Find You How does clinical research work? ...

  5. Quantifying and documenting prior beliefs in clinical trials.

    Science.gov (United States)

    Chaloner, K; Rhame, F S

    2001-02-28

    Collecting and documenting subjective prior beliefs from knowledgeable clinicians about the potential results of a clinical trial has many advantages. Two large trials of prophylactic treatments in an HIV-positive population are used as examples. The trials recruited patients of primary care physicians and compared treatments which were in use in clinical practice. Opinions about these trials were elicited from 58 practising HIV clinicians. It is shown how the documented opinions can be used to augment the monitoring process; the prior opinions are updated with interim data using approximate Bayesian methods to give posterior opinions incorporating interim results. These posterior opinions can be used by the monitoring board to anticipate the clinicians' reaction to the results. Eliciting prior beliefs is also ethically important for documenting the nature of the uncertainty or equipoise. Important information is provided for the informed consent process and Institutional Review Board (IRB). PMID:11223902

  6. IEA joint trials: new lessons from old plantations

    Energy Technology Data Exchange (ETDEWEB)

    Hall, R.B. (Iowa State Univ., IA (US). Dept. of Forestry); Ostry, M.E. (USDA Forest Service, St. Paul, MN (US)); Nordh, N.E. (Swedish Univ. of Agricultural Sciences, Uppsala (Sweden). Energy Forestry Project)

    1992-01-01

    Two international trials of potential biomass species families and clones planted in 1985 have been analyzed to determine changing patterns in growth, diseases, and insects. In the Swedish trial, with close spacing and short rotations, Salix viminalis clones gave the best average yield of 17.4 Mg/Ha/yr on the first coppice rotation. In the Minnesota, USA trial, with wider spacings and a longer rotation Populus alba hybrid clones gave the best average yields of 5.5 Mg/Ha/yr. The most important disease and insect problems encountered were Septoria musiva stem cankers on some Populus clones; frost die back in some Salix clones; and the leaf blotch miner, Fenusa dohrnii, on most Alnus families. Recommendations for future international cooperation in field trials are presented. (author).

  7. Challenges with engaging participants in behavioral intervention research trials

    Directory of Open Access Journals (Sweden)

    David Olem

    2009-11-01

    Full Text Available David Olem, Kelly M Sharp, Mallory O JohnsonDepartment of Medicine, University of California, San Francisco, CA, USAAbstract: In clinical trials research, nonadherence to an investigational health promotion intervention poses threats to internal validity, thus raising concern over the trial outcomes and interpretation of results. Successfully helping participants to engage in and complete a multisession intervention can be particularly challenging. This task can become more complicated when working with participants who are dealing with chronic health conditions and are from diverse cultural, socio-economic, and marginalized backgrounds who may have competing needs, beliefs, and priorities that conflict with the needs of the trial protocols. This paper identifies some of the challenges to helping individuals participate in the sessions of a behavioral intervention and shares a set of strategies developed by a clinical research team to engage with participants and minimize barriers to completing the intervention.Keywords: clinical trials, behavioral interventions, retention, internal validity

  8. Processes for Quality Improvements in Radiation Oncology Clinical Trials

    International Nuclear Information System (INIS)

    Quality assurance in radiotherapy (RT) has been an integral aspect of cooperative group clinical trials since 1970. In early clinical trials, data acquisition was nonuniform and inconsistent and computational models for radiation dose calculation varied significantly. Process improvements developed for data acquisition, credentialing, and data management have provided the necessary infrastructure for uniform data. With continued improvement in the technology and delivery of RT, evaluation processes for target definition, RT planning, and execution undergo constant review. As we move to multimodality image-based definitions of target volumes for protocols, future clinical trials will require near real-time image analysis and feedback to field investigators. The ability of quality assurance centers to meet these real-time challenges with robust electronic interaction platforms for imaging acquisition, review, archiving, and quantitative review of volumetric RT plans will be the primary challenge for future successful clinical trials

  9. CliniProteus: A flexible clinical trials information management system

    Science.gov (United States)

    Mathura, Venkatarajan S; Rangareddy, Mahendiranath; Gupta, Pankaj; Mullan, Michael

    2007-01-01

    Clinical trials involve multi-site heterogeneous data generation with complex data input-formats and forms. The data should be captured and queried in an integrated fashion to facilitate further analysis. Electronic case-report forms (eCRF) are gaining popularity since it allows capture of clinical information in a rapid manner. We have designed and developed an XML based flexible clinical trials data management framework in .NET environment that can be used for efficient design and deployment of eCRFs to efficiently collate data and analyze information from multi-site clinical trials. The main components of our system include an XML form designer, a Patient registration eForm, reusable eForms, multiple-visit data capture and consolidated reports. A unique id is used for tracking the trial, site of occurrence, the patient and the year of recruitment. Availability http://www.rfdn.org/bioinfo/CTMS/ctms.html. PMID:21670796

  10. Lung Cancer Screening Saves Lives: The National Lung Screening Trial

    Science.gov (United States)

    NCI funded the National Lung Screening Trial, an eight-year study that used new technology to detect small, aggressive tumors early enough to surgically remove them. This approach reduced lung cancer deaths among participants by 20 percent.

  11. Reducing trial length in force platform posturographic sleep deprivation measurements

    Science.gov (United States)

    Forsman, P.; Hæggström, E.; Wallin, A.

    2007-09-01

    Sleepiness correlates with sleep-related accidents, but convenient tests for sleepiness monitoring are scarce. The posturographic test is a method to assess balance, and this paper describes one phase of the development of a posturographic sleepiness monitoring method. We investigated the relationship between trial length and accuracy of the posturographic time-awake (TA) estimate. Twenty-one healthy adults were kept awake for 32 h and their balance was recorded, 16 times with 30 s trials, as a function of TA. The balance was analysed with regards to fractal dimension, most common sway amplitude and time interval for open-loop stance control. While a 30 s trial allows estimating the TA of individual subjects with better than 5 h accuracy, repeating the analysis using shorter trial lengths showed that 18 s sufficed to achieve the targeted 5 h accuracy. Moreover, it was found that with increasing TA, the posturographic parameters estimated the subjects' TA more accurately.

  12. Wrongful termination: lessons from the Geron clinical trial.

    Science.gov (United States)

    Scott, Christopher Thomas; Magnus, David

    2014-12-01

    Geron Corporation is a publically traded company that launched a phase I clinical trial of a human embryonic stem cell-based therapy for spinal cord injury. The company enrolled the first patient in October 2010 and stopped the trial 1 year later. The fifth patient had been enrolled but not transplanted when the company announced the trial's end. After discussions with clinical staff and family, an agreement was reached to add her to the cohort and proceed with the transplant. Two and half years later, the research is still waiting to restart. With this background in mind, we discuss the major ethical and social questions raised by the Geron case. We offer recommendations for institutional review boards and clinical sites as they deliberate approvals of early-phase trials in frontier medicine. PMID:25298371

  13. Locally aggressive colonic and rectal cancer ,clinical trial

    OpenAIRE

    Radu, V; Ion, D; ?erban, MB; Ciurea, M.

    2010-01-01

    This clinical trial studies local invasions from primary colonic and rectal cancers (urinary bladder, abdominal wall, small bowls, uterus, vagina, stomach, bile tract, spleen, duodenum, pancreas, ureters, kidneys), with or without undiscovered metastasis.

  14. Review of EGFR TKIs in metastatic NSCLC, including ongoing trials

    Directory of Open Access Journals (Sweden)

    BarbaraMelosky

    2014-09-01

    Full Text Available Recent clinical trials have demonstrated the efficacy of epidermal growth factor receptor (EGFR tyrosine kinase inhibitors (TKI in the treatment of patients with advanced metastatic non-small cell lung cancer. Most of these recent trials were conducted in patients with EGFR mutation-positive tumours. As our knowledge of the EGFR mutation and its resistant pathways develops, the complexity of the situation expands. This article briefly reviews the pivotal trials leading to approval of EGFR TKIs in the first-line setting for patients with EGFR mutation-positive non-small cell lung carcinomas. It discusses the historical use of EGFR TKIs after the first line setting in unselected patients and briefly describes ongoing trials.

  15. 'Cloud computing' and clinical trials: report from an ECRIN workshop.

    Science.gov (United States)

    Ohmann, Christian; Canham, Steve; Danielyan, Edgar; Robertshaw, Steve; Legré, Yannick; Clivio, Luca; Demotes, Jacques

    2015-01-01

    Growing use of cloud computing in clinical trials prompted the European Clinical Research Infrastructures Network, a European non-profit organisation established to support multinational clinical research, to organise a one-day workshop on the topic to clarify potential benefits and risks. The issues that arose in that workshop are summarised and include the following: the nature of cloud computing and the cloud computing industry; the risks in using cloud computing services now; the lack of explicit guidance on this subject, both generally and with reference to clinical trials; and some possible ways of reducing risks. There was particular interest in developing and using a European 'community cloud' specifically for academic clinical trial data. It was recognised that the day-long workshop was only the start of an ongoing process. Future discussion needs to include clarification of trial-specific regulatory requirements for cloud computing and involve representatives from the relevant regulatory bodies. PMID:26220186

  16. Lung Cancer Precision Medicine Trials: Adapting to Progress

    Science.gov (United States)

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

  17. A model for harmonizing flow cytometry in clinical trials

    OpenAIRE

    Maecker, Holden T.; McCoy, J. Philip

    2010-01-01

    Complexities in sample handling, instrument setup and data analysis are barriers to the effective use of flow cytometry to monitor immunological parameters in clinical trials. The novel use of a central laboratory may help mitigate these issues.

  18. Run-Reversal Equilibrium for Clinical Trial Randomization

    Science.gov (United States)

    Grant, William C.

    2015-01-01

    In this paper, we describe a new restricted randomization method called run-reversal equilibrium (RRE), which is a Nash equilibrium of a game where (1) the clinical trial statistician chooses a sequence of medical treatments, and (2) clinical investigators make treatment predictions. RRE randomization counteracts how each investigator could observe treatment histories in order to forecast upcoming treatments. Computation of a run-reversal equilibrium reflects how the treatment history at a particular site is imperfectly correlated with the treatment imbalance for the overall trial. An attractive feature of RRE randomization is that treatment imbalance follows a random walk at each site, while treatment balance is tightly constrained and regularly restored for the overall trial. Less predictable and therefore more scientifically valid experiments can be facilitated by run-reversal equilibrium for multi-site clinical trials. PMID:26079608

  19. Patients’ preferences for selection of endpoints in cardiovascular clinical trials

    Directory of Open Access Journals (Sweden)

    Robert D. Chow

    2014-02-01

    Full Text Available Background: To reduce the duration and overall costs of cardiovascular trials, use of the combined endpoints in trial design has become commonplace. Though this methodology may serve the needs of investigators and trial sponsors, the preferences of patients or potential trial subjects in the trial design process has not been studied. Objective: To determine the preferences of patients in the design of cardiovascular trials. Design: Participants were surveyed in a pilot study regarding preferences among various single endpoints commonly used in cardiovascular trials, preference for single vs. composite endpoints, and the likelihood of compliance with a heart medication if patients similar to them participated in the trial design process. Participants: One hundred adult English-speaking patients, 38% male, from a primary care ambulatory practice located in an urban setting. Key results: Among single endpoints, participants rated heart attack as significantly more important than death from other causes (4.53 vs. 3.69, p=0.004 on a scale of 1–6. Death from heart disease was rated as significantly more important than chest pain (4.73 vs. 2.47, p<0.001, angioplasty/PCI/CABG (4.73 vs. 2.43, p<0.001, and stroke (4.73 vs. 2.43, p<0.001. Participants also expressed a slight preference for combined endpoints over single endpoint (43% vs. 57%, incorporation of the opinions of the study patient population into the design of trials (48% vs. 41% for researchers, and a greater likelihood of medication compliance if patient preferences were considered during trial design (67% indicated a significant to major effect. Conclusions: Patients are able to make judgments and express preferences regarding trial design. They prefer that the opinions of the study population rather than the general population be incorporated into the design of the study. This novel approach to study design would not only incorporate patient preferences into medical decision making, but it also has the potential to improve compliance with cardiovascular medications.

  20. Unique perception of clinical trials by Korean cancer patients

    Directory of Open Access Journals (Sweden)

    Lee Su Jin

    2012-12-01

    Full Text Available Abstract Background In the past few years, the number of clinical trials has increased rapidly in East Asia, especially for gastric and hepatobiliary cancer that are prevalent in Asian populations. However, the actual degree of understanding or perceptions of clinical trials by cancer patients in East Asian countries have seldom been studied. Methods Between July 1st and November 30th of 2011, we conducted a prospective study to survey cancer patients regarding their awareness of, and willingness to participate in, a clinical trial. Patients with gastrointestinal/hepatobiliary cancer who visited the Hematology-Oncology outpatient clinic at Samsung Medical Center (SMC were enrolled. A total of 21 questions were asked including four questions which used the Visual analogue scale (VAS score. Results In this survey study, 1,000 patients were asked to participate and 675 patients consented to participate (67.5%. The awareness of clinical trials was substantially higher in patients who had a higher level of education (pp=0.004, and had a higher economic status (p=0.001. However, the willingness to participate in a clinical trial was not affected by the level of education or economic status of patients. The most influential factors for patient willingness to participate were a physician recommendation (n=181, 26.8%, limited treatment options (n=178, 26.4%, and expectations of effectiveness of new anti-cancer drugs (n=142, 21.0%. Patients with previous experience in clinical trials had a greater willingness to participate in clinical trials compared to patients without previous experience (p Conclusions This large patient cohort survey study showed that Korean cancer patients are more aware of clinical trials, but awareness did not translate into willingness to participate.

  1. West Berkshire perineal management trial: three year follow up.

    OpenAIRE

    Sleep, J; Grant, A

    1987-01-01

    Women who had participated in a randomised controlled trial of policies of restricted (10%) versus liberal (51%) episiotomy during spontaneous vaginal delivery were recontacted by postal questionnaire three years after delivery. Altogether 674 out of 1000 responded, and there was no evidence of a differential response rate between the two trial groups. Similar numbers of women in the two groups reported further deliveries, almost all of which had been vaginal and spontaneous. Fewer women allo...

  2. Reporting outcomes of back pain trials: A modified Delphi study

    DEFF Research Database (Denmark)

    Froud, Robert; Eldridge, Sandra; Kovacs, Francisco; Breen, Alan; Bolton, Jenni; Dunn, Kate; Fritz, Julie; Keller, Anne; Kent, Peter; Lauridsen, Henrik Hein; Ostelo, Raymond; Pincus, Tamar; Tulder, Maurits van; Vogel, Steven; Underwood, Martin

    2011-01-01

    BACKGROUND: Low back pain is a common and expensive health complaint. Many low back pain trials have been conducted, but these are reported in a variety of ways and are often difficult to interpret. AIM: To facilitate consensus on a statement recommending reporting methods for future low back pain trials. METHODS: We presented experts with clinicians' views on different reporting methods and asked them to rate and comment on the suitability reporting methods for inclusion in a standardized set. ...

  3. Human Computer Interaction Issues in Clinical Trials Management Systems

    OpenAIRE

    Starren, Justin B.; Payne, Philip R.O.; KAUFMAN, David R.

    2006-01-01

    Clinical trials increasingly rely upon web-based Clinical Trials Management Systems (CTMS). As with clinical care systems, Human Computer Interaction (HCI) issues can greatly affect the usefulness of such systems. Evaluation of the user interface of one web-based CTMS revealed a number of potential human-computer interaction problems, in particular, increased workflow complexity associated with a web application delivery model and potential usability problems resulting from the use of ambiguo...

  4. Spacing extinction trials alleviates renewal and spontaneous recovery

    OpenAIRE

    Urcelay, Gonzalo P; Wheeler, Daniel S.; Miller, Ralph R.

    2009-01-01

    Studies of extinction in classical conditioning situations can reveal techniques that maximize the effectiveness of exposure-based behavior therapies. In three experiments, we investigated the effect of varying the intertrial interval during an extinction treatment in a fear-conditioning preparation with rats as subjects. In Experiment 1, we found less fear at test (i.e., more effective extinction) when extinction trials were widely spaced, relative to intermediate or massed extinction trials...

  5. A pilot trial of dextromethorphan in amyotrophic lateral sclerosis.

    OpenAIRE

    Askmark, H; Aquilonius, S M; Gillberg, P G; Liedholm, L J; Stålberg, E; Wuopio, R

    1993-01-01

    Assuming the presence of glutamate-induced neurotoxicity in amyotrophic lateral sclerosis 14 patients were treated with dextromethorphan, an N-methyl-D-aspartate receptor antagonist. The patients were treated with 150 mg dextromethorphan or placebo daily for 12 weeks in a double-blind crossover trial, with a wash out period of 4 weeks between the two treatment periods. Thereafter the surviving patients were treated with 300 mg dextromethorphan daily for up to 6 months in an open trial. No pos...

  6. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton; Lundgren, Jens Dilling

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provid...

  7. Moxibustion for cephalic version: a feasibility randomised controlled trial

    OpenAIRE

    Bisits Andrew; Dahlen Hannah; Smith Caroline A; Do Carole K; Schmied Virginia

    2011-01-01

    Abstract Background Moxibustion (a type of Chinese medicine which involves burning a herb close to the skin) has been used to correct a breech presentation. Evidence of effectiveness and safety from systematic reviews is encouraging although significant heterogeneity has been found among trials. We assessed the feasibility of conducting a randomised controlled trial of moxibustion plus usual care compared with usual care to promote cephalic version in women with a breech presentation, and exa...

  8. Economic analysis and randomised controlled trials: an investment appraisal approach

    OpenAIRE

    Backhouse, Martin E.

    2006-01-01

    Randomised controlled trials (RCTs) play a fundamental role in the development and marketing activities of pharmaceutical companies. They are the primary means of evaluating the tolerability, safety and efficacy of a drug, and for providing information relevant for pricing and reimbursement decisions and clinical decision-making. RCTs require a substantial investment by pharmaceutical companies and the financial consequences of poorly or sub-optimally designed trials are potentially substanti...

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

    OpenAIRE

    Ayatollahi Seyyed; Jafari Peyman; Behboodian Javad

    2006-01-01

    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 infl...

  10. How to Calculate Sample Size in Randomized Controlled Trial?

    OpenAIRE

    ZHONG, Baoliang

    2009-01-01

    To design clinical trials, efficiency, ethics, cost effectively, research duration and sample size calculations are the key things to remember. This review highlights the statistical issues to estimate the sample size requirement. It elaborates the theory, methods and steps for the sample size calculation in randomized controlled trials. It also emphasizes that researchers should consider the study design first and then choose appropriate sample size calculation method.

  11. The Danish randomized lung cancer CT screening trial

    DEFF Research Database (Denmark)

    Pedersen, Jesper H; Ashraf, Haseem; Dirksen, Asger; Bach, Karen; Hansen, Hanne; Toennesen, Phillip; Thorsen, Hanne; Brodersen, John; Skov, Birgit Guldhammer; Døssing, Martin; Mortensen, Jann; Richter, Klaus; Clementsen, Paul; Seersholm, Niels

    2009-01-01

    INTRODUCTION: Lung cancer screening with low dose computed tomography (CT) has not yet been evaluated in randomized clinical trials, although several are underway. METHODS: In The Danish Lung Cancer Screening Trial, 4104 smokers and previous smokers from 2004 to 2006 were randomized to either screening with annual low dose CT scans for 5 years or no screening. A history of cigarette smoking of at least 20 pack years was required. All participants have annual lung function tests, and questionnair...

  12. Statins in heart failure: do we need another trial?

    OpenAIRE

    Bonsu KO; Kadirvelu A; Reidpath DD

    2013-01-01

    Kwadwo Osei Bonsu, Amudha Kadirvelu, Daniel Diamond ReidpathSchool of Medicine and Health Sciences, Monash University Sunway Campus, Bandar Sunway, MalaysiaAbstract: Statins lower serum cholesterol and are employed for primary and secondary prevention of cardiovascular events. Clinical evidence from observational studies, retrospective data, and post hoc analyses of data from large statin trials in various cardiovascular conditions, as well as small scale randomized trials, suggest survival a...

  13. Challenges with engaging participants in behavioral intervention research trials

    OpenAIRE

    David Olem; Kelly M Sharp; Johnson, Mallory O.

    2009-01-01

    David Olem, Kelly M Sharp, Mallory O JohnsonDepartment of Medicine, University of California, San Francisco, CA, USAAbstract: In clinical trials research, nonadherence to an investigational health promotion intervention poses threats to internal validity, thus raising concern over the trial outcomes and interpretation of results. Successfully helping participants to engage in and complete a multisession intervention can be particularly challenging. This task can become more complicated when w...

  14. Cohort Profile: The Promotion of Breastfeeding Intervention Trial (PROBIT)

    OpenAIRE

    Patel, Rita; Oken, Emily; Bogdanovich, Natalia; Matush, Lidia; Sevkovskaya, Zinaida; Chalmers, Beverley; Hodnett, Ellen D.; Vilchuck, Konstantin; Michael S. Kramer; Martin, Richard M.

    2013-01-01

    SummaryThe PROmotion of Breastfeeding Intervention Trial (PROBIT) is a multicentre, cluster-randomized controlled trial conducted in the Republic of Belarus, in which the experimental intervention was the promotion of increased breastfeeding duration and exclusivity, modelled on the Baby-friendly hospital initiative. Between June 1996 and December 1997, 17 046 mother–infant pairs were recruited during their postpartum hospital stay from 31 maternity hospitals, of which 16 hospitals and their ...

  15. Optimal Design for Experiments with Potentially Failing Trials

    OpenAIRE

    Hackl, Peter

    1994-01-01

    We discuss the problem of optimal allocation of the design points of an experiment for the case where the trials may fail with non-zero probability. Numerical results for D-optimal designs are given for estimating the coefficients of a polynomial regression. For small sample sizes these designs may deviate substantially from the corresponding designs in the case of certain response. They can be less efficient, but are less affected by failing trials. (author's abstract)

  16. Clinical Trials and the Projected Future of Liver Xenotransplantation

    OpenAIRE

    FUNG, JOHN; Rao, Abdul; Starzl, Thomas

    1997-01-01

    The trial and error of the pioneering xenotransplant trials over the past three decades has defined the limitation of the species used. Success was tantalizingly close with the chimpanzee, baboon, and other primates. The use of more disparate species has been frustrated by the xenoantibody barrier. Future attempts at clinical xenotransplantation will be hampered by the consideration of the species of animals and the nature of the organs to be transplanted. On one hand, primate donors have the...

  17. CliniProteus: A flexible clinical trials information management system

    OpenAIRE

    Mathura, Venkatarajan S; Rangareddy, Mahendiranath; GUPTA, PANKAJ; Mullan, Michael

    2007-01-01

    Clinical trials involve multi-site heterogeneous data generation with complex data input-formats and forms. The data should be captured and queried in an integrated fashion to facilitate further analysis. Electronic case-report forms (eCRF) are gaining popularity since it allows capture of clinical information in a rapid manner. We have designed and developed an XML based flexible clinical trials data management framework in .NET environment that can be used for eff...

  18. Assessing bias in osteoarthritis trials included in Cochrane reviews

    DEFF Research Database (Denmark)

    Hansen, Julie B; Juhl, Carsten Bogh; Boutron, Isabelle; Tugwell, Peter; Ghogomu, Elizabeth A T; Pardo Pardo, Jordi; Rader, Tamara; Wells, George A; Mayhew, Alain; Maxwell, Lara; Lund, Hans; Christensen, Robin

    2014-01-01

    INTRODUCTION: The validity of systematic reviews and meta-analysis depends on methodological quality and unbiased dissemination of trials. Our objective is to evaluate the association of estimates of treatment effects with different bias-related study characteristics in meta-analyses of interventions used for treating pain in osteoarthritis (OA). From the findings, we hope to consolidate guidance on interpreting OA trials in systematic reviews based on empirical evidence from Cochrane reviews. M...

  19. Controlled trial of balneotherapy in treatment of low back pain.

    OpenAIRE

    Konrad, K.; Tatrai, T; Hunka, A; Vereckei, E; Korondi, I

    1992-01-01

    Three treatments for non-specific lumbar pain--balneotherapy, underwater traction bath, and underwater massage--were assessed in a randomised prospective controlled trial in 158 outpatients. Each group was treated for four weeks and patients were reviewed at the end of this period and at 12 months after entry to the trial. The prescription of analgesics and the pain score were significantly reduced in all three treated groups, but there was no difference between the three groups. No significa...

  20. Single Trial Probability Applications: Can Subjectivity Evade Frequency Limitations?

    OpenAIRE

    David Howden

    2009-01-01

    Frequency probability theorists define an event’s probability distribution as the limit of a repeated set of trials belonging to a homogeneous collective. The subsets of this collective are events which we have deficient knowledge about on an individual level, although for the larger collective we have knowledge its aggregate behavior. Hence, probabilities can only be achieved through repeated trials of these subsets arriving at the established frequencies that define the probabilities. Crove...

  1. Methods for analyzing cost effectiveness data from cluster randomized trials

    OpenAIRE

    Clark Allan; Fairall Lara; Bachmann Max O; Mugford Miranda

    2007-01-01

    Abstract Background Measurement of individuals' costs and outcomes in randomized trials allows uncertainty about cost effectiveness to be quantified. Uncertainty is expressed as probabilities that an intervention is cost effective, and confidence intervals of incremental cost effectiveness ratios. Randomizing clusters instead of individuals tends to increase uncertainty but such data are often analysed incorrectly in published studies. Methods We used data from a cluster randomized trial to d...

  2. Detailed statistical analysis plan for the pulmonary protection trial

    DEFF Research Database (Denmark)

    Buggeskov, Katrine B; Jakobsen, Janus C

    2014-01-01

    BACKGROUND: Pulmonary dysfunction complicates cardiac surgery that includes cardiopulmonary bypass. The pulmonary protection trial evaluates effect of pulmonary perfusion on pulmonary function in patients suffering from chronic obstructive pulmonary disease. This paper presents the statistical plan for the main publication to avoid risk of outcome reporting bias, selective reporting, and data-driven results as an update to the published design and method for the trial. RESULTS: The pulmonary protection trial is a randomized, parallel group clinical trial that assesses the effect of pulmonary perfusion with oxygenated blood or CustodiolTM HTK (histidine-tryptophan-ketoglutarate) solution versus no pulmonary perfusion in 90 chronic obstructive pulmonary disease patients. Patients, the statistician, and the conclusion drawers are blinded to intervention allocation. The primary outcome is the oxygenation index from 10 to 15 minutes after the end of cardiopulmonary bypass until 24 hours thereafter. Secondary outcome measures are oral tracheal intubation time, days alive outside the intensive care unit, days alive outside the hospital, and 30- and 90-day mortality, and one or more of the following selected serious adverse events: pneumothorax or pleural effusion requiring drainage, major bleeding, reoperation, severe infection, cerebral event, hyperkaliemia, acute myocardial infarction, cardiac arrhythmia, renal replacement therapy, and readmission for a respiratory-related problem. CONCLUSIONS: The pulmonary protection trial investigates the effect of pulmonary perfusion during cardiopulmonary bypass in chronic obstructive pulmonary disease patients. A preserved oxygenation index following pulmonary perfusion may indicate an effect and inspire to a multicenter confirmatory trial to assess a more clinically relevant outcome.Trial registration: ClinicalTrials.gov identifier: NCT01614951, registered on 6 June 2012.

  3. Design of the Trial of Activity in Adolescent Girls (TAAG)

    OpenAIRE

    Stevens, June; MURRAY, DAVID M.; Catellier, Diane J; Hannan, Peter J; Lytle, Leslie A.; ELDER, JOHN P.; Young, Deborah R; Simons-Morton, Denise G.; Webber, Larry S

    2005-01-01

    The primary aim of the Trial of Activity in Adolescent Girls (TAAG) is to test an intervention to reduce by half the age-related decline in moderate to vigorous physical activity (MVPA) in middle school girls. The intervention will be evaluated using a group-randomized trial involving 36 middle schools. The primary endpoint is the mean difference in intensity-weighted minutes (i.e., MET-minutes) of MVPA between intervention and comparison schools assessed using accelerometry.

  4. Trial manufacture of x-band accelerator disks

    International Nuclear Information System (INIS)

    In the X-band accelerator scheme of future linear colliders with normal conductor technology, major issue was the mass production of accelerator structures and microwave transmission devices with ultrahigh precision. Hitachi Ltd. has a technology of ultrahigh precision machining of soft metals, and made trial manufacturing of accelerator disks with ultrahigh precision during half a year from the spring of 2004 based on the blueprint prepared by KEK. The results of this trial are reported. (K.Y.)

  5. Methodological quality and reporting of ethical requirements in clinical trials

    OpenAIRE

    Ruiz-Canela, M.; de Irala, J.; Martinez-Gonzalez, M.A.; Gomez-Gracia, E.; Fernandez-Crehuet, J. (Joaquín)

    2001-01-01

    Objectives—To assess the relationship between the approval of trials by a research ethics committee (REC) and the fact that informed consent from participants (ICP) was obtained, with the quality of study design and methods. Design—Systematic review using a standardised checklist. Main measures—Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British Me...

  6. Clinical trial design enabling {\\epsilon}-optimal treatment rules

    OpenAIRE

    Manski, Charles F.; Tetenov, Aleksey

    2015-01-01

    Medical research has evolved conventions for choosing sample size in randomized clinical trials that rest on the theory of hypothesis testing. Bayesians have argued that trials should be designed to maximize subjective expected utility in settings of clinical interest. This perspective is compelling given a credible prior distribution on treatment response, but Bayesians have struggled to provide guidance on specification of priors. We use the frequentist statistical decisio...

  7. Ethical Considerations for Clinical Trials in Inflammatory Bowel Disease

    OpenAIRE

    David T. Rubin; Becker, Samuel; Siegler, Mark

    2014-01-01

    Although advancements in the field of inflammatory bowel disease (IBD) include effective therapies for many patients with Crohn’s disease and ulcerative colitis, there remains a large unmet need, and there is a large number of investigational agents in the pipeline. Drug development through clinical trials is critical to understanding the safety and efficacy of new therapies in the affected human population, and the need for ethical trial design is of the utmost importance. This paper explore...

  8. Detailed statistical analysis plan for the pulmonary protection trial

    DEFF Research Database (Denmark)

    Buggeskov, Katrine B; Jakobsen, Janus C; Secher, Niels H; Jonassen, Thomas; Andersen, Lars W; Steinbrüchel, Daniel A; Wetterslev, Jørn

    2014-01-01

    BACKGROUND: Pulmonary dysfunction complicates cardiac surgery that includes cardiopulmonary bypass. The pulmonary protection trial evaluates effect of pulmonary perfusion on pulmonary function in patients suffering from chronic obstructive pulmonary disease. This paper presents the statistical plan for the main publication to avoid risk of outcome reporting bias, selective reporting, and data-driven results as an update to the published design and method for the trial. RESULTS: The pulmonary pro...

  9. Review of Clinical Trials for Mitochondrial Disorders: 1997–2012

    OpenAIRE

    Kerr, Douglas S.

    2013-01-01

    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 ora...

  10. Strategic Analysis of Clinical Trial Outsourcing to China

    OpenAIRE

    Yang, Haiyan

    2008-01-01

    With the increasing amounts of clinical data required for drug regulatory approval and the fierce competition for patients in the Western countries, the cost of clinical trials continues to rise considerably. This study suggests that outsourcing clinical trials to China is an effective strategy to reduce cost and cycle time of drug development. China offers a high market potential and strong research capacity that can provide long term benefits to pharmaceutical and biotech companies. An inte...

  11. Recommendations to choose the primary endpoint in cardiovascular clinical trials

    OpenAIRE

    Gómez Melis, Guadalupe; Gómez Mateu, Moisés; Dafni, Urania

    2013-01-01

    Background – A composite endpoint is often used as the primary endpoint to assess the efficacy of a new treatment in randomized clinical trials (RCT). In cardiovascular trials, the often rare event of the relevant primary endpoint (individual or composite), such as cardiovascular death (CV death), Myocardial Infarction (MI), or both, is combined with a more common secondary endpoint, such as target lesion revascularization, with the aim to increase the statistical power of the stu...

  12. MRI as an outcome in multiple sclerosis clinical trials.

    OpenAIRE

    M. Daumer; Neuhaus, A; Morrissey, S.; Hintzen, R.; Ebers, GC

    2009-01-01

    INTRODUCTION: T2-weighted and gadolinium enhanced T1-weighted MRI scans measure plaque burden and breakdown of the blood-brain barrier, respectively, in multiple sclerosis (MS) lesions. These have become widely used outcome measures for monitoring disease activity in clinical trials and clinical practice. However, their use as surrogates or biomarkers for disability and relapses, key clinical outcome measures, has remained incompletely validated. METHODS: In a clinical trial database comprise...

  13. Randomized Clinical Trials of Constitutional Acupuncture: A Systematic Review

    OpenAIRE

    Sun-Mi Choi; Jong Yeol Kim; Byung-Cheul Shin; Myeong Soo Lee

    2009-01-01

    The aim of this systematic review is to compile and critically evaluate the evidence from randomized clinical trials (RCTs) for the effectiveness of acupuncture using constitutional medicine compared to standard acupuncture. Ten databases were searched through to December 2008 without language restrictions. We also hand-searched nine Korean journals of oriental medicine. We included prospective RCTs of any form of acupuncture with or without electrical stimulation. The included trials had to ...

  14. Metadata-based analysis to improve clinical trial exchange

    OpenAIRE

    Luzi, Daniela (CNR-IRPPS); Ricci, Fabrizio L. (CNR-IRPPS); Serbanati, Luca D.; GreyNet, Grey Literature Network Service

    2006-01-01

    There are various, important information sources devoted to the diffusion of clinical trials, but they fail to achieve a complete coverage of clinical research. The demand for a mandatory public registration of clinical trials is emerging from different institutions, which are making efforts to develop common metadata schemas to both increase information exchange and make this information publicly available. The paper describes a metadata analysis of the various solutions of CT data represent...

  15. MIRANDA RULE. IMPACT ON THE ROMANIAN CRIMINAL TRIAL

    OpenAIRE

    Mircea DAMASCHIN; Corina DUMITRU

    2009-01-01

    We hereby want to analyze the right of the accused or of the defendant against self incrimination in a criminal trial, a relatively recent right introduced in the Romanian law, directly connected with the right to self defense in a criminal trial. Furthermore, we will approach the obligations held by the Romanian legislator, within the prerogatives of the criminal legal authorities for guaranteeing this right and meanings that can be retained in case of breach of such procedure. In order to e...

  16. Vitamins and minerals for women: recent programs and intervention trials

    OpenAIRE

    Greiner, Ted

    2011-01-01

    Women's nutrition has received little attention in nutrition programming, even though clinical trials and intervention trials have suggested that dietary improvement or supplementation with several nutrients may improve their health, especially in low-income settings, the main focus of this paper. Most attention so far has focused on how improvements in maternal nutrition can improve health outcomes for infants and young children. Adequate vitamin D and calcium nutrition throughout life may r...

  17. Ash Deposition Trials at Three Power Stations in Denmark

    DEFF Research Database (Denmark)

    Laursen, Karin; Frandsen, Flemming; Larsen, Ole Hede

    1998-01-01

    Six full-scale trials were conducted at three power stations in Denmark: Ensted, Funen, and Vendsyssel power stations. During these trials, pulverized coal, bottom ash, fly ash, and deposits from cooled probes were sampled and analyzed with various techniques. On the basis of SEM analyses, the deposits can be grouped into five textural types, which all possess distinct textural and chemical characteristics. Likewise, the deposition mechanisms for these five types are characteristic and they may ...

  18. Unfulfilled translation opportunities in industry sponsored clinical trials.

    Science.gov (United States)

    Smed, Marie; Getz, Kenneth A

    2013-05-01

    Knowledge generated by site representatives through their participation in clinical trials is valuable for testing new products in use and obtaining final market approval. The leverage of this important knowledge is however challenged as the former direct relationships between in-house staff in the industry and site representatives are changing. The process of clinical trials has increased in complexity over the years, resulting in additional management layers. Besides an increase in internal management layers, sponsors often also outsource various tasks related to clinical trials to a CRO (Contract Research Organization) and thereby adding another link in the relationships between site and sponsor. These changes are intended to optimize the time-consuming and costly trial phases; however, there is a need to study whether valuable knowledge and experience is compromised in the process. Limited research exists on the full range of clinical practice insights obtained by investigators during and after clinical trials and how well these insights are transferred to study sponsors. This study explores the important knowledge-transfer processes between sites and sponsors and to what extent sites' knowledge gained in clinical trials is utilized by the industry. Responses from 451 global investigative site representatives are included in the study. The analysis of the extensive dataset reveals that the current processes of collaboration between sites and the industry restrict the leverage of valuable knowledge gained by physicians in the process of clinical trials. These restrictions to knowledge-transfer between site and sponsor are further challenged if CRO partners are integrated in the trial process. PMID:23454567

  19. Consolidated Standards of Reporting Trials (CONSORT): considerations for neuropsychological research.

    Science.gov (United States)

    Miller, Justin B; Schoenberg, Mike R; Bilder, Robert M

    2014-01-01

    Evidence-based medicine (EBM) is a pillar of clinical medicine (Sackett, Rosenberg, Gray, Haynes, & Richardson, 1996 ), but only recently has this been systematically discussed within the context of clinical neuropsychology (e.g., Chelune, 2010 ). Across the medical sciences, randomized controlled trials (RCTs) are often considered the most important source of evidence for treatment efficacy. To facilitate the conduct, dissemination, and evaluation of research findings, reporting standards have been implemented, including the Consolidated Standards of Reporting Trials (CONSORT) statement. This paper considers the implications of the CONSORT statement for the reporting of clinical trials that include neuropsychological endpoints. Adopting specific guidelines for trials involving neuropsychology endpoints will ultimately serve to strengthen the empirical evidence base by increasing uniformity within the literature, decrease ambiguity in reporting, improving trial design, and fostering methodological transparency. Implementing uniform reporting standards will also facilitate meta-analytic review of evidence from published trials, benefiting researchers, clinicians, educators and practitioners, as well as journal editors, reviewers, and ultimately, health care consumers. PMID:24766549

  20. Participants' uptake of clinical trial results: a randomised experiment

    Science.gov (United States)

    Mancini, J; Genre, D; Dalenc, F; Ferrero, J-M; Kerbrat, P; Martin, A-L; Roché, H; Maylevin, F; Tarpin, C; Viens, P; Genève, J; Julian-Reynier, C

    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 received the letter of invitation) and a control group (who did not receive it). Among 115 HER2-positive women from 21 centres, 107 (93%) answered a self-administered questionnaire. Results: Most of the patients in both groups had access to the Internet (72.0%). The majority (97.2%) stated that receiving information about the trial results would be useful, and the oncologist was the most frequently preferred information provider. The Internet group's declared uptake of the trial results was only slightly higher (47.1% vs 33.9% P=0.166); however, they understood the results significantly more accurately (18.8% vs 5.6% P=0.039). Interpretation: Although Internet was not the respondents' preferred source of information, the possibility of using this source slightly increased the uptake and understanding of the results. PMID:20197767