WorldWideScience

Sample records for well-known arginusai trial

  1. Well-known Images of the Koran

    OpenAIRE

    YAVUZ, Ömer Faruk

    2011-01-01

    In this article, it will be discussed the huge impact of images or the prejudices in understanding of a text and impacts or manifestations of well-known Images of the Koran among Muslim individuals and societies. In this context, it will be dealt with more common Images of the Koran in the Muslim society by examining these images and trying to determine the healthy image of the Koran. These images of the Koran are as follows: Kor’an is the most accurate history book, prophetic book, prayer b...

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

    Science.gov (United States)

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

    2011-07-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

    Miari, Massimo

    1986-09-01

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

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

    OpenAIRE

    Mohammad Javad Ghasemi

    2014-01-01

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

  6. 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...

  7. Design of AQM in Supporting TCP Based on the Well-Known AIMD Model

    OpenAIRE

    Kim, Ki Baek; Tang, Ao; Low, Steven H.

    2003-01-01

    In this paper, we investigate how to design AQM with a low-pass filter (average queuing) in supporting TCP based on the well-known AIMD dynamic model. Since we formulate the AQM design problem for the given TCP as state-space models, we get three important features. First, we derive PD-type (Proportional-Derivative) AQM structure with a low-pass filter which includes P-type (Proportional) RED in terms of queue length. Second, we compensate for delays in congestion measure...

  8. 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.

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

    Science.gov (United States)

    Yedukondalu, N; Vaitheeswaran, G

    2015-11-28

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

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

    Science.gov (United States)

    Yedukondalu, N.; Vaitheeswaran, G.

    2015-11-01

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

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

    International Nuclear Information System (INIS)

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

  12. Assumptions for well-known statistical techniques: Disturbing explanations for why they are seldom checked

    Directory of Open Access Journals (Sweden)

    RinkHoekstra

    2012-05-01

    Full Text Available A valid interpretation of most statistical techniques requires that the criteria for one or more assumptions are met. In published articles, however, little information tends to be reported on whether the data satisfy the assumptions underlying the statistical techniques used. This could be due to self-selection: Only manuscripts with data fulfilling the assumptions are submitted. Another, more disquieting, explanation would be that violations of assumptions are hardly checked for in the first place. In this article a study is presented on whether and how 30 researchers checked fictitious data for violations of assumptions in their own working environment. They were asked to analyze the data as they would their own data, for which often used and well-known techniques like the t-procedure, ANOVA and regression were required. It was found that they hardly ever checked for violations of assumptions. Interviews afterwards revealed that mainly lack of knowledge and nonchalance, rather than more rational reasons like being aware of the robustness of a technique or unfamiliarity with an alternative, seem to account for this behavior. These data suggest that merely encouraging people to check for violations of assumptions will not lead them to do so, and that the use of statistics is opportunistic.

  13. Cardiac surgery and hypertension: a dangerous association that must be well known.

    Science.gov (United States)

    Yuan, Shi-Min; Jing, Hua

    2011-01-01

    It is well-known that hypertension is a very common disease, and severe cerebrovascular accidents might occur if the blood pressure is not properly controlled. However, conditions associated with uncontrolled hypertension may be overlooked, and may become critical and eventually require a surgical intervention on an urgent basis. Coronary artery disease, acute aortic syndrome, congenital and valvular heart disease, and arrhythmias are under this topic of discussion. Of them, coronary artery disease including myocardial infarction and especially postinfarction myocardial rupture, and aortic dissection are major critical situations that physicians may encounter in clinical practice. The role that hypertension plays in these conditions can be complex, including hemodynamic, electrophysiological and biomolecular factors, where the latter may prevail in the current era. Coronary artery disease may be associated with a reduced nitric oxide synthesis. Transforming growth factor and matrix metalloproteinases have been observed in relation to aortic syndrome. Wnt, p38 and JNK signaling pathway may be involved in the development of ventricular hypertrophy responsible for cardiac arrythmias. Various gene phynotypes may present in different congenital heart defects. This article is to present these conditions, and to further discuss the possible etiologies and the potential treatment strategies so as to highlight the relevance at a prognostic level. PMID:21894419

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

    Science.gov (United States)

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

    2005-02-01

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

  15. 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

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

    OpenAIRE

    Phan Ngoc, Tam

    2011-01-01

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

  17. 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

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

    Science.gov (United States)

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

    2015-03-01

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

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

    International Nuclear Information System (INIS)

    A critical analysis is given of the well-known expression for the electron-impact ionization rate constant αi of neutral atoms and ions, derived by linearization of the ionization cross section σi(ε) as a function of the electron energy near the threshold I and containing the characteristic factor (I + 2kT). Using the classical Thomson expression for the ionization cross section, it is shown that in addition to the linear slope of σi(ε), 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 αi (∼4kT/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

  20. 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.

  1. 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...

  2. 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

  3. 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.

  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. 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.

  6. 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.

  7. Cardiac surgery and hypertension: a dangerous association that must be well known Cirurgia cardíaca e hipertensão: uma associação perigosa que deve ser bem conhecida

    Directory of Open Access Journals (Sweden)

    Shi-Min Yuan

    2011-06-01

    Full Text Available It is well-known that hypertension is a very common disease, and severe cerebrovascular accidents might occur if the blood pressure is not properly controlled. However, conditions associated with uncontrolled hypertension may be overlooked, and may become critical and eventually require a surgical intervention on an urgent basis. Coronary artery disease, acute aortic syndrome, congenital and valvular heart disease, and arrhythmias are under this topic of discussion. Of them, coronary artery disease including myocardial infarction and especially postinfarction myocardial rupture, and aortic dissection are major critical situations that physicians may encounter in clinical practice. The role that hypertension plays in these conditions can be complex, including hemodynamic, electrophysiological and biomolecular factors, where the latter may prevail in the current era. Coronary artery disease may be associated with a reduced nitric oxide synthesis. Transforming growth factor and matrix metalloproteinases have been observed in relation to aortic syndrome. Wnt, p38 and JNK signaling pathway may be involved in the development of ventricular hypertrophy responsible for cardiac arrythmias. Various gene phynotypes may present in different congenital heart defects. This article is to present these conditions, and to further discuss the possible etiologies and the potential treatment strategies so as to highlight the relevance at a prognostic level.É sabido que a hipertensão é uma doença muito comum, e que os acidentes cerebrovasculares graves podem ocorrer se a pressão sanguínea não for apropriadamente controlada. Contudo, as condições associadas à hipertensão não controlada podem ser negligenciadas, e tornarem-se críticas, necessitando, eventualmente, uma intervenção cirúrgica urgente. Doença coronariana, síndrome aórtica aguda, cardiopatias congênitas, valvopatias e arritmias são sob este tópico de discussão. Dentre eles, a doença corornariana, inclusive o infarto do miocárdio e especialmente a ruptura cardíaca pós-infarto e a dissecção aórtica, são as situações críticas principais que os médicos podem encontrar na prática clínica. O papel que a hipertensão desempenha nessas condições pode ser complexo, incluindo fatores hemodinâmicos, eletrofisiológicos e biomoleculares, nos quais o último pode prevalecer atualmente. A doença coronariana pode associar-se com uma redução na síntese de óxido nítrico. Fator de crescimento transformador e nas metaloproteinases da matriz têm sido observados em relação à síndrome aórtica. O Wnt, p38 e a via de sinalização JNK caminho podem estar implicado no desenvolvimento da hipertrofia ventricular responsável por arritmias cardíacas. Vários fenótipos dos genes podem apresentar defeitos cardíacos congênitos diferentes. Este artigo apresenta essas condições, e discute, além disso, possíveis etiologias e as estratégias de tratamento potenciais bem destacar sua importância quanto a prognóstico.

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

    Science.gov (United States)

    Herrmann, F.; Schmalzle, P.

    1981-01-01

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

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

    OpenAIRE

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

    2011-01-01

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

  10. Accretion onto Some Well-Known Regular Black Holes

    CERN Document Server

    Jawad, Abdul

    2016-01-01

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

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

    Directory of Open Access Journals (Sweden)

    G. R. Mohtashami Borzadaran

    2011-12-01

    Full Text Available Interesting properties and propositions, in many branches of science such as economics have been obtained according to the property of cumulative distribution function of a random variable as a concave function. Caplin and Nalebuff (1988,1989, Bagnoli and Khanna (1989 and Bagnoli and Bergstrom (1989 , 1989, 2005 have discussed the log-concavity property of probability distributions and their applications, especially in economics. Log-concavity concerns twice differentiable real-valued function g whose domain is an interval on extended real line. g as a function is said to be log-concave on the interval (a,b if the function ln(g is a concave function on (a,b. Log-concavity of g on (a,b is equivalent to g'/g being monotone decreasing on (a,b or (ln(g" 6] have obtained log-concavity for distributions such as normal, logistic, extreme-value, exponential, Laplace, Weibull, power function, uniform, gamma, beta, Pareto, log-normal, Student's t, Cauchy and F distributions. We have discussed and introduced the continuous versions of the Pearson family, also found the log-concavity for this family in general cases, and then obtained the log-concavity property for each distribution that is a member of Pearson family. For the Burr family these cases have been calculated, even for each distribution that belongs to Burr family. Also, log-concavity results for distributions such as generalized gamma distributions, Feller-Pareto distributions, generalized Inverse Gaussian distributions and generalized Log-normal distributions have been obtained.

  12. A Well-Known but Still Surprising Generator

    Science.gov (United States)

    Haugland, Ole Anton

    2014-01-01

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

  13. Accretion onto some well-known regular black holes

    Science.gov (United States)

    Jawad, Abdul; Shahzad, M. Umair

    2016-03-01

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

  14. Accretion onto Some Well-Known Regular Black Holes

    OpenAIRE

    Jawad, Abdul; Shahzad, M. Umair

    2016-01-01

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

  15. Accretion onto some well-known regular black holes

    OpenAIRE

    Jawad, Abdul; Shahzad, M. Umair

    2016-01-01

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

  16. A Well-Known but Still Surprising Generator

    Science.gov (United States)

    Haugland, Ole Anton

    2014-01-01

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

  17. DISTRIBUCIN, HISTORIA NATURAL Y CONSERVACIN DE UNA RANA MARSUPIAL POCO CONOCIDA, GASTROTHECA HELENAE (ANURA: HEMIPHRACTIDAE), EN EL PARQUE NACIONAL NATURAL TAM, COLOMBIA / DISTRIBUTION, NATURAL HISTOR Y AND CONSERVATION OF THE NOT VERY WELL KNOWN MARSUPIAL FROG GASTROTHECA HELENAE (ANURA: HEMIPHRACTIDAE) IN THE TAM 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 distribucin al estar restringida al complejo Macizo El Tam compartido por Colombia y Venezuela. Evaluamos el estado actual de sus poblaciones mediante la bsqueda en nuevas localidades y describimos aspectos de la historia n [...] atural de la especie, con el fin de generar futuros planes de conservacin 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 Tam 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.

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

    DEFF Research Database (Denmark)

    Hare, Kristoffer B; Lohmander, L Stefan; Roos, Ewa M.

    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...... 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....

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

    Directory of Open Access Journals (Sweden)

    Mª del Mar González-Martín

    2016-01-01

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

  20. Clinical Trials

    Science.gov (United States)

    ... Trials Brochure (PDF) Learn more about participating in reseach Clinical Trials A clinical trial is a study ... therapy and another group may receive a standard method of psychotherapy or a combination of psychotherapy and ...

  1. Clinical Trials

    Science.gov (United States)

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

  2. Characteristics of clinical trial websites: information distribution between ClinicalTrials.gov and 13 primary registries in the WHO registry network

    OpenAIRE

    Ogino, Daisuke; Takahashi, Kunihiko; Sato, Hajime

    2014-01-01

    Background It is well known that information about clinical trials is not easily accessible by the public. In Japan, clinical trial information can be accessed by the general public through online registries; however, many people find these registries difficult to use. To improve current clinical trial registries, we propose that combining them with clinical information phrased in lay terms would be beneficial to other interested professionals such as journalists and clinicians, as well as th...

  3. Whose data set is it anyway? Sharing raw data from randomized trials

    OpenAIRE

    Vickers Andrew J

    2006-01-01

    Abstract Background Sharing of raw research data is common in many areas of medical research, genomics being perhaps the most well-known example. In the clinical trial community investigators routinely refuse to share raw data from a randomized trial without giving a reason. Discussion Data sharing benefits numerous research-related activities: reproducing analyses; testing secondary hypotheses; developing and evaluating novel statistical methods; teaching; aiding design of future trials; met...

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

    Science.gov (United States)

    Garca Fernndez, Francisco Pedro; Lpez Casanova, Pablo; Pancorbo Hidalgo, Pedro Luis; Verd Soriano, Jos

    2009-01-01

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

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

    OpenAIRE

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

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Pradeep Singh

    2015-12-01

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

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

    Science.gov (United States)

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

    2010-01-01

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

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

    Science.gov (United States)

    da Costa, Viviana C P; Annunziata, Onofrio

    2015-11-21

    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

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

    OpenAIRE

    Kos, Janko; Viin, Tjaa

    2015-01-01

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

  10. New expectations from the well-known medicinal properties of Arctium lappa.

    Science.gov (United States)

    Miele, C; Beguinot, F

    2012-05-01

    AMP-activated protein kinase (AMPK) serves as a major regulator of energy homeostasis and is activated by different glucose-lowering agents. Indeed, AMPK has been identified as an attractive target for the development of innovative molecules to treat type 2 diabetes. In this issue of Diabetologia (doi: 10.1007/s00125-011-2366-3 ), Huang and co-workers report that arctigenin activates muscle uptake of glucose and inhibits hepatocyte gluconeogenesis and lipogenesis by reducing mitochondrial respiration and inducing AMPK activity. Importantly, it is reported that arctigenin improves glucose and lipid metabolism in ob/ob mice. Based on this evidence, Huang and co-workers suggest that arctigenin may represent a valuable lead compound for developing innovative glucose-lowering molecules. While these findings are not entirely novel and mechanistic investigations are needed, the results strongly support the concept that arctigenin deserves to be further considered because of its several potentially beneficial in vivo effects. In particular, the authors conclude that further mechanistic studies on arctigenin might provide novel insight and opportunities for selective modulation of subcutaneous and visceral fat mass. PMID:22358500

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

    DEFF Research Database (Denmark)

    Cedhagen, Tomas

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

  12. Zika virus disease: a new look at a well-known disease

    Directory of Open Access Journals (Sweden)

    I. V. Shestakova

    2016-04-01

    Full Text Available For the first time in the domestic medical literature presents a deep review about epidemiological, clinical, and laboratory knowledge of Zika virus disease, based mainly on the publications of foreign authors and leading international organizations from 1947 to March 2016. Analyzed the essence of the problem, treatment of patients with Zika virus disease and infected pregnant women, indicated the unresolved question. For the first time were systematic sources of contemporary information about Zika virus disease for professionals and patients.

  13. 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

  14. Zika virus disease: a new look at a well-known disease

    OpenAIRE

    I. V. Shestakova

    2016-01-01

    For the first time in the domestic medical literature presents a deep review about epidemiological, clinical, and laboratory knowledge of Zika virus disease, based mainly on the publications of foreign authors and leading international organizations from 1947 to March 2016. Analyzed the essence of the problem, treatment of patients with Zika virus disease and infected pregnant women, indicated the unresolved question. For the first time were systematic sources of contemporary information abou...

  15. 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 α,ω-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.

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

    Index Scriptorium Estoniae

    Maar, Ellu, 1982-

    2010-01-01

    Graafik ja fotograaf Jaan Kleikost, kes on 45 aastat jdvustanud kunsti- ja kultuurisndmusi. Galerii Vaal kodulehel ilmunud J. Kleiko fotoseeriatest (12), fotod valis ja saatesnad kirjutas J. Kleiko

  17. 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.

  18. 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...

  19. A generalization of some well-known distances and related isometries

    OpenAIRE

    Çolakoğlu, Harun Bariş; Kaya, Rüstem

    2011-01-01

    In this paper, we define a family of distance functions in the real plane, m-distance function, which includes the taxicab, Chinese checker, maximum, and alpha distance functions as special cases, and we show that the m-distance function determines a metric. Then we give some properties of the m-distance, and determine isometries of the plane with respect to the m-distance. Finally, we extend the m-distance function to three and n-dimensional spaces, and show that each...

  20. 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

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

    OpenAIRE

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

    2011-01-01

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

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

    OpenAIRE

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

    2014-01-01

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

  3. 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.

  4. Disease-mongering through clinical trials.

    Science.gov (United States)

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

    2015-06-01

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

  5. 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 ...

  6. The Trial

    Science.gov (United States)

    Bryant, Jen

    2004-01-01

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

  7. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... treatment, screening, diagnostic, prevention, and supportive care trials. Treatment Trials In treatment trials, researchers may gather information about experimental treatments, ...

  8. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects ... Trials In treatment trials, researchers may gather information about experimental treatments, their risks, and how well they ...

  9. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Usually, trial participants must show signs of the disease or condition before they can join this type of trial. Prevention Trials Click for more information In prevention trials, ...

  10. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A ... to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described ...

  11. Participating in Clinical Trials

    Science.gov (United States)

    ... this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical ... to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described based ...

  12. Clinical Trial Basics

    Science.gov (United States)

    ... of clinical research make a difference? What are clinical trials and why do people participate? Clinical trials are ... them ineligible to continue the study. Types of clinical trials There are different types of clinical trials. Natural ...

  13. Participating in Clinical Trials

    Medline Plus

    Full Text Available Home > Health topics A-Z > Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks ... centers across the country. The National Institutes of Health funds much of this basic research. Screening Trials ...

  14. 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? ... trial is right for you. What is a clinical trial? A clinical trial is a particular type of ...

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study ... lifestyle changes, such as exercising more, getting more sleep, keeping mentally active, or eating nutritious foods, can ...

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study that involves human subjects. The purpose ...

  17. Towards sustainable clinical trials

    OpenAIRE

    Group, Sustainable Trials Study

    2007-01-01

    Currently, few researchers think about the carbon footprint of their trial. The Sustainable Trials Study Group reports that clinical trials are carbon intensive and suggests ways to make them more efficient

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... trial is to find out if an experimental drug, therapy, medical device, lifestyle change, or test will ... disease. Phases of Clinical Trials Clinical trials of drugs are usually described based on their phase. The ...

  19. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical ... to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described based ...

  20. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed Consent Should I Join a Clinical Trial? Frequently Asked ... experimental treatments, their risks, and how well they work compare existing therapies ...

  1. Clinical Trials in Vision Research

    Science.gov (United States)

    ... Eye Health Information > Clinical Trials in Vision Research Clinical Trials in Vision Research Listen Clinical studies depend on ... vision research in the United States. Basics of Clinical Trials What is a clinical trial? Clinical trials are ...

  2. 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 clinical ... protect patients and help produce reliable study results. Clinical Trial Protocol Each clinical trial has a master plan ...

  3. Clinical Trial Results: A Clinical Trial Bazaar!

    OpenAIRE

    Fojo, Antonio Tito; Bates, Susan E

    2014-01-01

    The Oncologist’s Clinical Trial Results section welcomes both positive and negative results in an effort to share information, speed discovery, and inform the field. Clinical Trial Results submissions have shown how succinctly the salient features of a submission can be presented, with more in-depth information to be found online.

  4. 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 Gölbaşı 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.

  5. 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

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

    DEFF Research Database (Denmark)

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

    2011-01-01

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

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

    Science.gov (United States)

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

    2002-07-01

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

  8. 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

  9. Antitumor Activity of Artemisinin and Its Derivatives: From a Well-Known Antimalarial Agent to a Potential Anticancer Drug

    OpenAIRE

    WEI, MING Q.; Crespo-Ortiz, Maria P.

    2011-01-01

    Improvement of quality of life and survival of cancer patients will be greatly enhanced by the development of highly effective drugs to selectively kill malignant cells. Artemisinin and its analogs are naturally occurring antimalarials which have shown potent anticancer activity. In primary cancer cultures and cell lines, their antitumor actions were by inhibiting cancer proliferation, metastasis, and angiogenesis. In xenograft models, exposure to artemisinins substantially reduces tumor volu...

  10. 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

  11. 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.

  12. 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.

  13. 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

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

    OpenAIRE

    Vizin Tjasa; Kos Janko

    2015-01-01

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

  15. 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.)

  16. 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)

  17. 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.

  18. 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

  19. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical ... researchers may gather information about experimental treatments, their risks, and how well they work compare existing therapies ...

  20. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... determine if the drug can be approved for use. A Phase I trial tests an experimental treatment ... the correct drug dosage. A Phase II trial uses more people (100 to 300). While the emphasis ...

  1. 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.

  2. 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 Z ... Staging Prognosis Treatment Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer ...

  3. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Institutes of Health funds much of this basic research. Screening Trials In screening trials, researchers study ways of finding a disease before symptoms occur. These methods, often called screening tests, can include imaging tests ...

  4. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... of Health funds much of this basic research. Screening Trials In screening trials, researchers study ways of finding a disease before symptoms occur. These methods, often called screening tests, can include imaging tests that produce pictures ...

  5. Hepatitis C: Clinical Trials

    Science.gov (United States)

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

  6. The Kindergarten Clinical Trial

    OpenAIRE

    Janice Weinberg

    2009-01-01

    Janice WeinbergDepartment of Biostatistics, Boston University School of Public Health, Boston, MA, USAAbstract: The author describes an imaginary clinical trial performed using her daughter’s kindergarten class in Arlington, Massachusetts as study subjects. The children are introduced to several age-appropriate concepts related to clinical trials including defining a study question and randomization. Basic concepts in clinical trials are introduced, the Kindergarten Clinical Trial i...

  7. Salem Witch Trials.

    Science.gov (United States)

    Ray, Benjamin

    2003-01-01

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

  8. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... topic was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study ...

  9. 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 ...

  10. 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 ...

  11. 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 Information ...

  12. 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.

  13. Compliance in clinical trials.

    OpenAIRE

    Pullar, T; Kumar, S.; Feely, M

    1989-01-01

    Compliance with treatment can be an important determinant of the outcome of clinical trials. To date there is no completely satisfactory method of measuring compliance and some of the most widely used methods are inadequate. The various methods of measuring compliance and how they have been applied to clinical trials are described, and improvements in the standard of the measurement and reporting of compliance in clinical trials are suggested.

  14. Comparability of prostate trials

    DEFF Research Database (Denmark)

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

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

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... disease or prevent a disease from returning. Supportive Care Trials In supportive care trials, researchers look for ways to make life ... groups, and various types of social interventions. Supportive care interventions are not intended to treat or cure ...

  16. Clinical trial structures

    OpenAIRE

    Evans, Scott R

    2010-01-01

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

  17. CLINICAL TRIALS.GOV

    Science.gov (United States)

    ClinicalTrials.gov provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Institutes of Health (NIH), through its National Library of Medi...

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ... 000 people. If the U.S. Food and Drug Administration agrees that the trial results are positive, they ...

  19. Miscanthus production field trials

    Energy Technology Data Exchange (ETDEWEB)

    Jones, B. [University Coll., Dublin (Ireland)

    1993-12-31

    Under the E.C. Joule program in 1989, a European network started on 18 sites a replicated production trial of an asian plant to produce biomass. The trials show that it is possible to successfully establish a Miscanthus crop under a wide range of climatic and edaphic conditions in Europe. Tests and results are presented. (TEC).

  20. The COLOFOL trial

    DEFF Research Database (Denmark)

    Hansdotter Andersson, Pernilla; Wille-Jørgensen, Peer; Horváth-Puhó, Erzsébet; Petersen, Sune Høirup; Martling, Anna; Sørensen, Henrik Toft; Syk, Ingvar

    2016-01-01

    trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study. MATERIALS AND METHODS: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient......INTRODUCTION: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL...... stage and localization. The analyses will be stratified by these variables. Taken together, we conclude that our trial results will be robust and possible to extrapolate to the target population....

  1. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

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

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...... both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials and their...... utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety of...

  2. A trial bank model for the publication of clinical trials.

    OpenAIRE

    I. Sim; Rennels, G.

    1995-01-01

    Clinical trials constitute one of the main sources of medical knowledge, yet trial reports are difficult to find, read, and apply to clinical care. Reasons for these difficulties include the lack of a common, standardized, structure for trial reports; the restricted length of reports; and limited computer support for use of the literature. We propose a new model of reporting clinical trials, in which trials are published as both prose commentary and as data in electronic "trial banks." The pr...

  3. Clinical Research and Clinical Trials

    Science.gov (United States)

    ... of Health A-Z Topics | Directory Connect with us: Toggle navigation Health & Research A-Z Topics Symptoms, treatments, research, articles, clinical trials, resources Clinical Trials & Clinical Research Find clinical trials, ...

  4. Glossary of Clinical Trials Terms

    Science.gov (United States)

    ... results data element on ClinicalTrials.gov.) ALLOCATION A clinical trial design strategy used to assign participants to an ... A group or subgroup of participants in a clinical trial that receives specific interventions , or no intervention, according ...

  5. 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 ...

  6. 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

  7. Inept media trials of clinical trials

    Directory of Open Access Journals (Sweden)

    N V Ramamurthy

    2012-01-01

    Full Text Available The Indian media in general, with the exception of a few domain expert journalists, have failed to comprehend the complexities involved in the clinical trial process. In the run up to the deadline-based coverage of a story, a majority of them fall short in conveying the right perspective to readers, but nevertheless they have been successful in sensationalizing an event in this arena. Possibly by unintended misrepresentation, or mostly out of ignorance of the nuances involved in the clinical trials process, the media has done more harm than good, and got away with it. On the other side, the industry has been reluctant to engage with the media in a meaningful dialog for too long now. It bears not only the consequences of damage to its professional reputation following such reportage, but also the repercussions of unnecessary clampdowns by the regulators. Science journalism in India has yet to rise as a profession.

  8. Narrating the Mensalo 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 mensalo 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...

  9. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in this topic was provided by the National ...

  10. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or tests to those already available or may compare existing ...

  11. Who's in Clinical Trials?

    Science.gov (United States)

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

  12. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... in this topic was provided by the National Library of Medicine Topic last reviewed: December 2013 For ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ...

  13. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or ... of them, is the best treatment for a disease evaluate treatment methods such as surgical techniques, psychiatric ...

  14. Clinical Trial Basics

    Science.gov (United States)

    ... help others and to contribute to moving science forward. Participants with an illness or disease also participate ... the study? Cost issues Will I have to pay for any part of the trial such as ...

  15. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials ...

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... ways of finding a disease before symptoms occur. These methods, often called screening tests, can include imaging ... getting a disease or a specific medical problem. These trials find out if lifestyle changes, such as ...

  17. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... if an experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent ... medical problem. These trials find out if lifestyle changes, such as exercising more, getting more sleep, keeping ...

  19. Clinical Trials: New Developments

    OpenAIRE

    2000-01-01

    Canadian respiratory health research is recognized as being among the best worldwide. Many Canadian researchers are leaders in international projects, including large scale clinical trials. There is, however, a need to develop a structure that could foster the collaboration of Canadian investigators in joint projects of this sort. In the past few years, discussions have taken place on what could be a Canadian Thoracic Society (CTS) Clinical Trials Group. This is a wonderful opportunity to put...

  20. 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.

  1. Complementary and Alternative Medicine Cancer Clinical Trials

    Science.gov (United States)

    ... Introduction Cancer CAM Clinical Trials Introduction What are clinical trials? A clinical trial is one of the final ... and effective. What are the different types of clinical trials? Treatment trials test new treatments (like a new ...

  2. Trial incentive in sequential litigation

    OpenAIRE

    Bernhardt, D.; Xu, Z

    2012-01-01

    We analyze when and why trials can emerge in equilibrium when a defendant may sequentially face multiple plaintiffs. Subsequent potential plaintiffs learn about their chances of winning from the initial trial outcome. A trial in the initial case is like an experiment that the defendant can run that would induce plaintiffs’ learning. We show that the initial case can go to trial in equilibrium when a favorable trial outcome for the defense can deter potential future plaintiffs from filing laws...

  3. Hahnemann and the methodology of pathogenetic trials in healthy volunteers: a reappraisal.

    Directory of Open Access Journals (Sweden)

    Jim Rogers

    2010-10-01

    Full Text Available This article assesses the guidelines and protocols that Hahnemann developed for homeopathic pathogenetic trials (HPTs - often referred to as proving - and reappraise them in the light of more recent knowledge and protocols for clinical trials involving human subjects. Innovative features and methods introduced by Hahnemann and aimed at reducing bias are noted. A number of features which are now known to lead to bias in trials and which may be included in the reporting of symptoms are discussed in relation to HPTs. These features include: absence of control groups, absence of random allocation, absence of blinding, the inclusion of trivial and pre-existing symptoms, the inclusion of well-known acquaintances as trial participants, and the lack of definition of the healthy state. Advice from experts and papers published in recent decades related to the design of HPTs are discussed. The importance of developing methods to screen participants in HPTs for susceptibility to the tested medicine is discussed. The absence of trials meeting high quality standards in their design is highlighted. The article concludes with a plea for researchers to show the same desire for rigour and innovation that Hahnemann did in the development of HPTs, whilst fully recognising the requirements and protocols necessary for any trial of medicines on human beings, so that, as Hahnemann wanted, only reliable symptoms from HPTs will be admitted in the materia medica and clinical practice.

  4. Whose data set is it anyway? Sharing raw data from randomized trials

    Directory of Open Access Journals (Sweden)

    Vickers Andrew J

    2006-05-01

    Full Text Available Abstract Background Sharing of raw research data is common in many areas of medical research, genomics being perhaps the most well-known example. In the clinical trial community investigators routinely refuse to share raw data from a randomized trial without giving a reason. Discussion Data sharing benefits numerous research-related activities: reproducing analyses; testing secondary hypotheses; developing and evaluating novel statistical methods; teaching; aiding design of future trials; meta-analysis; and, possibly, preventing error, fraud and selective reporting. Clinical trialists, however, sometimes appear overly concerned with being scooped and with misrepresentation of their work. Both possibilities can be avoided with simple measures such as inclusion of the original trialists as co-authors on any publication resulting from data sharing. Moreover, if we treat any data set as belonging to the patients who comprise it, rather than the investigators, such concerns fall away. Conclusion Technological developments, particularly the Internet, have made data sharing generally a trivial logistical problem. Data sharing should come to be seen as an inherent part of conducting a randomized trial, similar to the way in which we consider ethical review and publication of study results. Journals and funding bodies should insist that trialists make raw data available, for example, by publishing data on the Web. If the clinical trial community continues to fail with respect to data sharing, we will only strengthen the public perception that we do clinical trials to benefit ourselves, not our patients.

  5. 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

  6. 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...

  7. Adaptive trial designs.

    Science.gov (United States)

    Lai, Tze Leung; Lavori, Philip William; Shih, Mei-Chiung

    2012-01-01

    We review adaptive designs for clinical trials, giving special attention to the control of the Type I error in late-phase confirmatory trials, when the trial planner wishes to adjust the final sample size of the study in response to an unblinded analysis of interim estimates of treatment effects. We point out that there is considerable inefficiency in using the adaptive designs that employ conditional power calculations to reestimate the sample size and that maintain the Type I error by using certain weighted test statistics. Although these adaptive designs have little advantage over familiar group-sequential designs, our review also describes recent developments in adaptive designs that are both flexible and efficient. We also discuss the use of Bayesian designs, when the context of use demands control over operating characteristics (Type I and II errors) and correction of the bias of estimated treatment effects. PMID:21838549

  8. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  9. A 12-week multidomain intervention versus active control to reduce risk of Alzheimer’s disease: study protocol for a randomized controlled trial

    OpenAIRE

    Anstey, Kaarin J.; Bahar-Fuchs, Alex; Herath, Pushpani; Rebok, George W.; Cherbuin, Nicolas

    2013-01-01

    Background Disappointing results from clinical trials of disease-modifying interventions for Alzheimer’s dementia (AD), along with reliable identification of modifiable risk factors in mid life from epidemiological studies, have contributed to calls to invest in risk-reduction interventions. It is also well known that AD-related pathological processes begin more than a decade before the development of clinical signs. These observations suggest that lifestyle interventions might be most effect...

  10. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... order to determine which one is safer or more effective. The five main types of clinical trials are treatment, screening, ... surgical techniques, psychiatric therapy, or radiotherapy. Click for more information Scientists usually do years of experiments in the laboratory and in ...

  11. Randomized clinical trial

    DEFF Research Database (Denmark)

    Olesen, Anne Estrup; Nielsen, Lecia Møller; Larsen, Isabelle Myriam; Drewes, Asbjørn Mohr

    2015-01-01

    METHODS: The study was a randomized, double-blinded, placebo-controlled, crossover trial in healthy males. Esophageal electrical, thermal, mechanical, and chemical stimulations were performed, pain perception was rated, and referred pain areas were drawn. Sensitization was induced by intraluminal...

  12. 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...

  13. 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...

  14. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... usually described based on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 ... to about 3,000 people. If the U.S. Food and Drug Administration agrees that the trial results are positive, ...

  15. HIV/AIDS Clinical Trials

    Science.gov (United States)

    ... Home Apps APIs Widgets Order Publications Skip Nav HIV/AIDS Clinical Trials Home > Clinical Trials Español Text ... Renal (Kidney) Complications/Damage Skin Diseases FDA-Approved HIV Drugs Abacavir Atazanavir Atripla Cobicistat Combivir Complera Darunavir ...

  16. Inconsistent treatment estimates from mis-specified logistic regression analyses of randomized trials.

    Science.gov (United States)

    Matthews, J N S; Badi, N H

    2015-08-30

    When the difference between treatments in a clinical trial is estimated by a difference in means, then it is well known that randomization ensures unbiassed estimation, even if no account is taken of important baseline covariates. However, when the treatment effect is assessed by other summaries, for example by an odds ratio if the outcome is binary, then bias can arise if some covariates are omitted, regardless of the use of randomization for treatment allocation or the size of the trial. We present accurate closed-form approximations for this asymptotic bias when important normally distributed covariates are omitted from a logistic regression. We compare this approximation with ones in the literature and derive more convenient forms for some of these existing results. The expressions give insight into the form of the bias, which simulations show is usable for distributions other than the normal. The key result applies even when there are additional binary covariates in the model. PMID:25869059

  17. 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-salbutamol cream 0.5% and 18 to placebo - and treated twice daily for 8 weeks. Efficacy was...... significantly higher in the active group compared with the placebo group (P = 0.013), and a statistically significantly greater decrease in the size of the lesional area was also seen in the overall analysis of the R-salbutamol-treated patients (P = 0.0197). No serious adverse events were reported. CONCLUSIONS...

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

    Directory of Open Access Journals (Sweden)

    Suh Sang-Yeon

    2012-01-01

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

  19. Randomised clinical trial

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  20. Randomised clinical trial

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  1. NATO SOCMET trials

    Science.gov (United States)

    Jenden, C. M.

    1993-11-01

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

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

    Science.gov (United States)

    Netser, Shai; Dutta, Arkadeb; Gutfreund, Yoram

    2014-03-01

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

  3. MindTrial: An Intelligent System for Clinical Trials

    OpenAIRE

    Lee, Yugyung; Dinakarpandian, Deendayal; Katakam, Nikhilesh; Owens, Dennis

    2010-01-01

    The recruitment of human subjects for clinical trials research is a critically important step in the discovery of new cures for diseases. However, the current recruitment methodologies are inherently inefficient. Considerable resources are expended in efforts to recruit adequate numbers of patient volunteers who meet the inclusion/exclusion criteria for clinical trials. Recruitment is particularly challenging for trials involving vulnerable, psychiatrically disordered groups. We have develope...

  4. 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

  5. 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 (In) 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

  6. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2008-10-01

    Gateways to clinical trials is a guide to the most recent trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (+)-Dapoxetine hydrochloride, (S)-Tenatoprazole sodium salt monohydrate 19-28z, Acotiamide hydrochloride hydrate, ADV-TK, AE-37, Aflibercept, Albinterferon alfa-2b, Aliskiren fumarate, Asenapine maleate, Axitinib; Bavituximab, Becatecarin, beta-1,3/1,6-Glucan, Bevacizumab, Bremelanotide; Calcipotriol/betamethasone dipropionate, Casopitant mesylate, Catumaxomab, CDX-110, Cediranib, CMD-193, Cositecan; Darinaparsin, Denosumab, DP-b99, Duloxetine hydrochloride; E75, Ecogramostim, Elacytarabine, EMD-273063, EndoTAG-1, Enzastaurin hydrochloride, Eplerenone, Eribulin mesilate, Esomeprazole magnesium, Etravirine, Everolimus, Ezetimibe; Faropenem daloxate, Febuxostat, Fenretinide; Ghrelin (human); I-131 ch-TNT-1/B, I-131-3F8, Iclaprim, Iguratimod, Iloperidone, Imatinib mesylate, Inalimarev/Falimarev, Indacaterol, Ipilimumab, Iratumumab, Ispinesib mesylate, Ixabepilone; Lapatinib ditosylate, Laquinimod sodium, Larotaxel dehydrate, Linezolid, LOR-2040; Mapatumumab, MKC-1, Motesanib diphosphate, Mycophenolic acid sodium salt; NK-012; Olanzapine pamoate, Oncolytic HSV, Ortataxel; Paclitaxel nanoparticles, Paclitaxel poliglumex, Paliperidone palmitate, Panitumumab, Patupilone, PCV-9, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pertuzumab, Picoplatin, Pimavanserin tartrate, Pimecrolimus, Plerixafor hydrochloride, PM-02734, Poly I:CLC, PR1, Prasugrel, Pregabalin, Progesterone caproate, Prucalopride, Pumosetrag hydrochloride; RAV-12, RB-006, RB-007, Recombinant human erythropoietin alfa, Rimonabant, Romidepsin; SAR-109659, Satraplatin, Sodium butyrate; Tadalafil, Talampanel, Tanespimycin, Tarenflurbil, Tariquidar, Taurine, Tecovirimat, Telatinib, Telavancin hydrochloride, Telcagepant, Terameprocol, Tesofensine, Tetrodotoxin, Tezampanel, Tipifarnib, TPI-287, Tremelimumab; Valspodar, Vatalanib succinate, VCL-CB01, vCP1452, Vorinostat; XL-228; Ziprasidone hydrochloride. PMID:19088949

  7. Quality Assurance for Clinical Trials

    OpenAIRE

    GeoffreyStephenIbbott; AnnetteHaworth; DavidScottFollowill

    2013-01-01

    Cooperative groups, of which the Radiation Therapy Oncology Group (RTOG) is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several QA offices that is is charged with assuring that participating institu...

  8. Gateways to clinical trials.

    Science.gov (United States)

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

    2003-12-01

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

  9. 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)

  10. Vicarious trial and error.

    Science.gov (United States)

    Redish, A David

    2016-02-19

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1990-06-01

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

  13. 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. Original article The effect of three-dimensional imaging of well-known objects on time and accuracy of mental rotation

    Directory of Open Access Journals (Sweden)

    Piotr Francuz

    2014-07-01

    Full Text Available Background The purpose of this study was to verify hypotheses concerning the effect of three-dimensional imaging and the canonicity of objects presented in the original position on the reaction time (RT and the accuracy (A of mental rotation task (MRT execution. The classical paradigm of MRT, developed by Shepard and Metzler (1971, was used in the experiment. Participants and procedure One hundred fifty-eight undergraduate students (88 female and 70 male, aged 18-30 years, participated in the experiment. All participants had normal vision or corrected vision, and reported no stereo blindness. The sequential version of the MRT was used in the experiment. Participants answered whether the object observed in the second position was only rotated or both rotated and mirror-reversed, in comparison to its original position. The answer (accuracy and its latency (RT were recorded. Results As predicted by the mental rotation model, both the “U”-shaped A-MRT distribution and the inverted “U”-shaped RT-MRT distribution were found, due to the angular disparity. For the RT-MRT, this effect was more pronounced when the objects were displayed stereoscopically than in a plane, and when the objects were presented in the original position from the canonical orientation rather than an unusual point of view. On the other hand, in the case of the A-MRT, an effect of the orientation of objects presented in the original position on strengthening the relationship between accuracy and angular disparity was found. Conclusions The results indicated that the interactions between the presentation of the objects in the mental rotation task (stereoscopically vs. in a plane and the orientation of the object in its original position (canonically vs. unusual are more complicated than would appear from predictions of classical theories of mental rotation. The results of this study are discussed in relation to the theories of recognition and categorization.

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

    OpenAIRE

    Aremu, A.O.; Stirk, W. A.; Kulkarni, M. G.; Tarkowsk, D. (Danue); Ture?kov, V. (Veronika); Grz, J. (Ji?); ubrtov, M. (Michaela); P?n?k, A. (Ale); Novk, O.; Doleal, K. (Karel); Strnad, M.; van Staden, J.

    2015-01-01

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

  16. 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 ").

  17. 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

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

    Science.gov (United States)

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

    2014-11-01

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

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

    OpenAIRE

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

    2014-01-01

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

  20. 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

  1. 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; Turečková, Veronika; Grúz, Jiří; Šubrtová, Michaela; Pěnčík, Aleš; Novák, Ondřej; Doležal, Karel; Strnad, Miroslav; van Staden, J.

    2015-01-01

    Roč. 75, č. 2 (2015), s. 483-492. ISSN 0167-6903 R&D Projects: GA MŠk LK21306; GA ČR 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

  2. Market trials of irradiated chicken

    International Nuclear Information System (INIS)

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

  3. Dramatization of Salem Witch Trial.

    Science.gov (United States)

    Chorak, Elizabeth

    1988-01-01

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

  4. 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...

  5. Defendants' Rights in Criminal Trials.

    Science.gov (United States)

    Martin, Ralph C., II; Keeley, Elizabeth

    1997-01-01

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

  6. 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.

  7. 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. |

  8. 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.

  9. Social media in clinical trials.

    Science.gov (United States)

    Thompson, Michael A

    2014-01-01

    Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape. PMID:24857086

  10. The Dynamo Clinical Trial

    Science.gov (United States)

    Ayres, Thomas R.

    2016-04-01

    The Dynamo Clinical Trial evaluates long-term stellar magnetic health through periodic X-ray examinations (by the Chandra Observatory). So far, there are only three subjects enrolled in the DTC: Alpha Centauri A (a solar-like G dwarf), Alpha Cen B (an early K dwarf, more active than the Sun), and Alpha Canis Majoris A (Procyon, a mid-F subgiant similar in activity to the Sun). Of these, Procyon is a new candidate, so it is too early to judge how it will fare. Of the other two, Alpha Cen B has responded well, with a steady magnetic heartbeat of about 8 years duration. The sickest of the bunch, Alpha Cen A, was in magnetic cardiac arrest during 2005-2010, but has begun responding to treatment in recent years, and seems to be successfully cycling again, perhaps achieving a new peak of magnetic health in the 2016 time frame. If this is the case, it has been 20 years since A's last healthful peak, significantly longer than the middle-aged Sun's 11-year magnetic heartbeat, but perhaps in line with Alpha Cen A's more senescent state (in terms of "relative evolutionary age," apparently an important driver of activity). (By the way, don't miss the exciting movie of the Alpha Cen stars' 20-year X-ray dance.)

  11. [Euripides and Heraclitus on the attitude towards the corpse--an unrecognized fragment of Heraclitus in Electra, v. 289].

    Science.gov (United States)

    Moog, Ferdinand Peter

    2007-01-01

    Among the fragments of Heraclitus preserved to our times there is one saying that corpses ought to be disposed of more urgently than excrements Diels/Kranz 22 B 96. This sentence of an aphoristic nature, as frequently in the case of Heraclitus' scripts, allows many different interpretations. Even in antiquity these words led to vitriolic reactions and perplexed other writers. It is why they have been frequently quoted. Nevertheless, it has been overlooked until now that Euripides, the youngest of the three great Attic tragedians, had inserted them into one of his dramas. In his Electra it is the title figure who uses them while reporting the slaughter of Agamemnon. The quotation bears witness to Euripides' erudition as of one of the earliest men known to have possessed a private library. He must, therefore, have had access to many treatises on various subjects, among them to the work by Heraclitus. The Electra is a kind of homage to the obscure thinker from Ephesus. From this fact, and from the plot of this particular play, we may gain some insight into an ambivalent attitude of the ancient Greeks towards the corpse that certainly influenced ideas about human anatomy in particular and medical knowledge in general. A characteristic feature of the malefactors, namely Aigisthos and Clytaimestra, is the deliberate dishonouring of their victims corpse. By contrast, the noble characters Orestes and Electra never violate the corpse of their arch-enemy Aigisthos, but see to it that he is properly buried. Burial was, particularly in Athens, so essential that in the well-known Arginusai trial the failure to bury the fallen soldiers resulted in capital punishment for the accused. Nevertheless, it is likely that Euripides, following Heraclitus, did not reject the anatomical examination of corpses for scientific purposes, as he was not only in this regard a supporter of science and progress. Perhaps Plato's notion of the human body as the tomb of the soul is foreshadowed here. This notion may have helped demythologize the corpse. Anyway, it is striking to observe the beginnings of the so-called Hippocratic medicine on the coast of Asia Minor and the near islands. It is exactly this part of the world where the pre-Socratics had made their first attempts at reasoning about the nature of being and made the transition from mythos to logos a few generations earlier. That intellectual climate was certainly good for nourishing scientific ideas of paramount importance. Heraclitus was without doubt one of the deepest-thinking pre-Socratics. The acceptance of his results by many critical thinkers of the time, such as Euripides, helped them attain their due recognition. PMID:18354901

  12. Bayes' postulate for trinomial trials

    Science.gov (United States)

    Diniz, M. A.; Polpo, A.

    2012-10-01

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

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

    Directory of Open Access Journals (Sweden)

    Ayatollahi Seyyed

    2006-01-01

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

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

    Science.gov (United States)

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

    2012-11-15

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

  15. 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.

  16. The ALCHEMIST Lung Cancer Trial

    Science.gov (United States)

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

  17. Types of Treatment: Clinical Trials

    Science.gov (United States)

    ... Previous Article Palliative Care Next Article How a Clinical Trial Works Follow us Subscribe to a newsletter This field is required ... Fundraising Disclosure Refund Policy Work for LLS Contact Us Email Subscription Center

  18. Global warming on trial

    International Nuclear Information System (INIS)

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

  19. Adaptive designs in clinical trials

    OpenAIRE

    Suresh Bowalekar

    2011-01-01

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

  20. Malaria Diagnostics in Clinical Trials

    OpenAIRE

    Murphy, Sean C.; Joseph P. Shott; Parikh, Sunil; Etter, Paige; Prescott, William R.; Stewart, V Ann

    2013-01-01

    Malaria diagnostics are widely used in epidemiologic studies to investigate natural history of disease and in drug and vaccine clinical trials to exclude participants or evaluate efficacy. The Malaria Laboratory Network (MLN), managed by the Office of HIV/AIDS Network Coordination, is an international working group with mutual interests in malaria disease and diagnosis and in human immunodeficiency virus/acquired immunodeficiency syndrome clinical trials. The MLN considered and studied the wi...

  1. Acupuncture trials and informed consent

    OpenAIRE

    Miller, F G; Kaptchuk, T J

    2007-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Athina Tzovara

    2011-11-01

    Full Text Available Decision-making in an uncertain environment is driven by two major needs: exploring the environment to gather information or exploiting acquired knowledge to maximize reward. The processes underlying exploratory decision-making have been mainly studied by means of functional magnetic resonance imaging leaving their temporal aspects under-explored. Here, using a well-known gambling paradigm in reinforcement learning we aim at detecting when in time, at the single-trial level, the brain generators responsible for these decisions have been sufficiently activated to lead to the following decision. Our analyses, following a classification scheme, are based on extracting time-unlocked voltage topographies during reward presentation and using them to predict decisions made on the next trial. Classification accuracy, measured as the area under the Receiver Operators Characteristic curve was on average across 7 subjects 0.650.02. The crucial time period, over which enough evidence was accumulated to accurately make this prediction, started from the display of the previous reward and lasted on average across trials and subjects up to 57018 ms post-stimulus. On an individual subject basis, distributed source estimations were performed on the extracted topographies to statistically evaluate the neural correlates of decision making. For trials leading to exploration, there was significantly higher activity in dorsolateral prefrontal cortex and in the right parietal supramarginal gyrus; areas responsible for task-switching and modulating behavior under risk and deduction. No area was more active during exploitation. We show for the first time the temporal evolution of differential patterns of brain activation in an exploratory decision-making task on a single-trial basis.

  3. Globalization of Alzheimer's disease clinical trials

    OpenAIRE

    Cummings, Jeffrey; Reynders, Robert; Zhong, Kate

    2011-01-01

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

  4. Endpoints in cancer clinical trials.

    Science.gov (United States)

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

    2014-02-01

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

  5. A review of international clinical trial registration

    OpenAIRE

    Yu, He; Jian-ping LIU

    2007-01-01

    ABSTRACT: Clinical trials play a critical role in medical research. However, only a few clinical trials conducted at present have been registered at various clinical trial registries. Clinical trial registration can prevent bias in these registered trials effectively and avoid unnecessary waste of resources due to meaningless repeats. Moreover, it will benefit the development of evidence-based medicine, and promote human welfare. Great attention has been paid to the importance and necessity o...

  6. Interventional trials in atypical parkinsonism.

    Science.gov (United States)

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

    2016-01-01

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

  7. The FIB-PPH trial

    DEFF Research Database (Denmark)

    Wikkelsoe, Anne J; Afshari, Arash; Stensballe, Jakob; Langhoff-Roos, Jens; Albrechtsen, Charlotte; Ekelund, Kim; Hanke, Gabriele; Sharif, Heidi; Mitchell, Anja U; Svare, Jens; Troelstrup, Ane; Pedersen, Lars M; Lauenborg, Jeannet; Gøttge, Mette; Bødker, Birgit; Moeller, Ann M

    2012-01-01

    haemostasis and thus worsening the ongoing bleeding. A plasma level of fibrinogen below 2 g/L in the early phase of postpartum haemorrhage is associated with subsequent development of severe haemorrhage. Use of fibrinogen concentrate allows high-dose substitution without the need for blood type cross match....... So far no publications of randomised controlled trials involving acutely bleeding patients in the obstetrical setting have been published. This trial aims to investigate if early treatment with fibrinogen concentrate reduces the need for blood transfusion in women suffering severe PPH. METHODS: In...... this randomised placebo controlled double blind multicenter trial, parturients with primary PPH are eligible following vaginal delivery in case of: Manual removal of placenta (blood loss [greater than or equal to] 500 ml) or manual exploration of the uterus after the birth of placenta (blood loss...

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

  9. Prototype aircraft development trials with particular reference to tropical trials

    Directory of Open Access Journals (Sweden)

    S. C. Keshu

    1958-04-01

    Full Text Available Flight development trials on prototype aircraft play a vital part in the design and development programme of a new aircraft and facilitate the introduction of the aircraft for operational use in Air Force Squadrons. The facilities required for such flight testing, the training of technical personnel and the organization of a flight test center are briefly described.

  10. Ongoing clinical trials in AKI.

    Science.gov (United States)

    Faubel, Sarah; Chawla, Lakhmir S; Chertow, Glenn M; Goldstein, Stuart L; Jaber, Bertrand L; Liu, Kathleen D

    2012-05-01

    AKI is an important public health issue. AKI is a common hospital complication associated with increased in-hospital and long-term mortality, extensive morbidity (including prolonged hospital length of stay), and an estimated annual cost of at least $10 billion in the United States. At present, no specific therapy has been developed to prevent AKI, hasten recovery of kidney function, or abrogate the deleterious systemic effects of AKI. However, recent progress includes establishing a consensus definition of AKI and discovery of novel biomarkers that may allow early detection of AKI. Furthermore, significant insights into the pathophysiology of AKI and its deleterious systemic effects have been gleaned from animal studies. Urgently needed are large, definitive randomized clinical trials testing interventions to prevent and/or treat AKI. This review summarizes and analyzes current ongoing clinical trials registered with clinicaltrials.gov that address prevention or management of AKI. The purpose of this review is to provide a resource for people interested in potential prophylactic and therapeutic approaches to patient care and investigators hoping to plan and execute the next round of randomized clinical trials. Finally, this review discusses research needs that are not addressed by the current clinical trials portfolio and suggests key areas for future research in AKI. PMID:22442183

  11. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

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

    2007-01-01

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

  12. Trials for malpractice on radiodiagnostics

    International Nuclear Information System (INIS)

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

  13. 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.

  14. Clinical Trials Shed Light on Minority Health

    Science.gov (United States)

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

  15. Clinical Trials: Key to Medical Progress

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: Key to Medical Progress Past Issues / Summer 2008 ... this page please turn Javascript on. Photo iStock Clinical trials are research studies that test how well new ...

  16. Optimising the analysis of stroke trials

    OpenAIRE

    Gray, Laura Jayne

    2008-01-01

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

  17. Microbicide clinical trial adherence: insights for introduction

    OpenAIRE

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

    2013-01-01

    After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase...

  18. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

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

  19. 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 ... safe and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help ...

  20. 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…

  1. 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.

  2. 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 Clinical ... conducted all the time. The Different Phases of Clinical Trials Clinical trials related to drugs are classified into ...

  3. GPON FTTH trial: lessons learned

    Science.gov (United States)

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

    2009-11-01

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

  4. Pediatric Obstructive Uropathy: Clinical Trials

    International Nuclear Information System (INIS)

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

  5. The design of multicentre trials.

    Science.gov (United States)

    Fedorov, Valerii; Jones, Byron

    2005-06-01

    The analysis of data collected in multicentre trials offers challenges because the data from the individual centres must be combined in some way to give an overall evaluation of the differences between the treatments in the trial. We propose that the combined response to treatment (CRT) be used as this overall measure. The definition and estimation of the CRT can be derived from either a fixed-effects or a random-effects model. For the latter we introduce the ECRT--the expected combined response to treatment. We describe and compare both types of model and express our preference for the random-effects model. We stress that the number of patients enrolled at a centre is a random variable and show that this source of randomness inflates the variance of the estimated ECRT. Variability in enrolment rates over the centres further inflates this variance. A simple conclusion from our results is that if variability in the treatment and centre effects, in the enrolment time, in the number of patients enrolled at a centre and in the enrolment rates is not properly accounted for, then an underpowered trial may result. Using properties of estimators generated by the random-effects model we propose methods for determining the optimal number of centres and total number of patients to enrol in a trial to minimize a loss function that accounts for centre and patient costs and loss of revenue. We discuss variants of the loss function and corresponding optimization problems for different types of enrolment. We end the paper with brief generalizations of the developed techniques to the case where the response is binary. PMID:15969302

  6. VTT Field Trial Finnish Experiences

    International Nuclear Information System (INIS)

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

  7. 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...

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

    OpenAIRE

    Renfro, Lindsay A.; Shi, Qian; Xue, Yuan; LI, JUNLONG; Shang, Hongwei; Sargent, Daniel J.

    2014-01-01

    Evaluation of candidate surrogate endpoints using individual patient data from multiple clinical trials is considered the gold standard approach to validate surrogates at both patient and trial levels. However, this approach assumes the availability of patient-level data from a relatively large collection of similar trials, which may not be possible to achieve for a given disease application. One common solution to the problem of too few similar trials involves performing trial-level surrogac...

  9. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

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

    2010-01-01

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

  10. 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

  11. 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.

  12. Acceptance Checklist for Clinical Effectiveness Pilot Trials: a systematic approach.

    OpenAIRE

    Charlesworth, G.; Burnell, K.; Hoe, J.; Orrell, M; Russell, I

    2013-01-01

    Conducting a pilot trial is important in preparing for, and justifying investment in, the ensuing larger trial. Pilot trials using the same design and methods as the subsequent main trial are ethically and financially advantageous especially when pilot and main trial data can be pooled. For explanatory trials in which internal validity is paramount, there is little room for variation of methods between the pilot and main trial. For pragmatic trials, where generalisability or external validity...

  13. Credentialing for participation in clinical trials

    Directory of Open Access Journals (Sweden)

    ThomasFitzgerald

    2012-12-01

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

  14. Design of surgical randomized controlled trials involving multiple interventions

    DEFF Research Database (Denmark)

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

    2011-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Daly Fergus

    2007-03-01

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

  16. Data monitoring committees for pragmatic clinical trials.

    Science.gov (United States)

    Ellenberg, Susan S; Culbertson, Richard; Gillen, Daniel L; Goodman, Steven; Schrandt, Suzanne; Zirkle, Maryan

    2015-10-01

    In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical trials require careful consideration when developing interim data monitoring plans, and trial sponsors, investigators, and data monitoring committees should agree on a plan before trial inception. Finally, special expertise, such as an informatics, may be helpful on data monitoring committees for some pragmatic clinical trials. Patient representatives may provide particularly valuable insights in the monitoring process. PMID:26374679

  17. Microbicide clinical trial adherence: insights for introduction

    Directory of Open Access Journals (Sweden)

    Cynthia Woodsong

    2013-04-01

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

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

    Science.gov (United States)

    Sleight, P

    2004-02-01

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

  19. 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

  20. 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

  1. Guidelines for planning clinical trials.

    Science.gov (United States)

    Forbes, J F

    1977-10-01

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

  2. Legislation for trial registration and data transparency

    Directory of Open Access Journals (Sweden)

    Wu Tai-Xiang

    2010-05-01

    Full Text Available Abstract Public confidence in clinical trials has been eroded by data suppression, misrepresentation and manipulation. Although various attempts have been made to achieve universal trial registration- e.g., Declaration of Helsinki, WHO clinical Trial Registry Platform (WHO ICTRP, the International Committee of Medical Journal Editors requirement- they have not succeeded, probably because they lack the enough power of enforcement. Legislation appears to be the most efficient and effective means to ensure that all researchers register their trials and disseminate their data accurately and in a timely manner. We propose that a global network be established. This could be accomplished in two steps. The first step is to legislate about trial registration and data transparency, such as USA's FDAAA Act 2007; and the second step to establish a global network to ensure uniform, international consistency in policy and enforcement of trial registration and data transparency.

  3. Future clinical trials: Principles versus practice

    International Nuclear Information System (INIS)

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

  4. 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

  5. A systematic review of homeopathic pathogenetic trials

    OpenAIRE

    Rogers, J.

    2009-01-01

    Homeopathic medicine remains widely used in Britain and around the world. The evidence on which homeopaths base decisions about which homeopathic medicines to prescribe comes largely from homeopathic pathogenetic trials ( HPTs).Such trials aim to produce pathogenetic effects in healthy participants by administering repeated doses of a homeopathic medicine. A previous systematic review of the quality of all such trials performed between 1945 and 1995 found that they were generally of poor qual...

  6. RECENT CLINICAL TRIALS IN LUPUS NEPHRITIS

    OpenAIRE

    Ward, Michael M

    2014-01-01

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

  7. 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

  8. Clinical trials with fast neutrons in Europe

    International Nuclear Information System (INIS)

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

  9. Trials and tribulations in charged particle radiotherapy

    International Nuclear Information System (INIS)

    A number of aspects of radiotherapy using protons and ions such as carbon and neon are discussed, focusing less on the oft-enumerated advantages or potential advantages of these particles as on those aspects which are, or may be, problematic. First, for protons and so-called heavy ions separately, the potential advantages and disadvantages of the particles, on physical and radiobiological grounds, are reviewed and some outstanding problems, both technical and scientific, are enumerated. Then, mention is made of the danger that financial pressures can lead to suboptimal medical care of patients. Finally, the issue of clinical trials, and especially randomized clinical trials, is addressed. On the one hand, very few randomized trials have been reported. On the other hand, there is a widespread desire to see trials of charged particle therapy undertaken. The ethical considerations are briefly reviewed and it is concluded that they pose strong limitations on the types of trials which can be undertaken. Nevertheless, some clinical trials would certainly be appropriate and desirable and a number are suggested, under the categories of retrospective non-randomized clinical trials, prospective non-randomized clinical trials, and prospective-randomized clinical trials.

  10. Carbon cost of pragmatic randomised controlled trials: retrospective analysis of sample of trials

    OpenAIRE

    Lyle, Katy; Dent, Louise; Bailey, Sally; Kerridge, Lynn; Roberts, Ian; Milne, Ruairidh

    2009-01-01

    Objective To calculate the global warming potential, in carbon dioxide (CO2) equivalent emissions, from a sample of pragmatic randomised controlled trials. Design Retrospective analysis. Data source Internal data held by NIHR Evaluation, Trials and Studies Coordinating Centre. Studies included All eligible pragmatic randomised controlled trials funded by the NIHR Health Technology Assessment programme during 2002 and 2003. Main outcome measure CO2 equivalents for trial activities calculated w...

  11. Making trials matter: pragmatic and explanatory trials and the problem of applicability

    OpenAIRE

    Treweek Shaun; Zwarenstein Merrick

    2009-01-01

    Abstract Randomised controlled trials are the best research design for decisions about the effect of different interventions but randomisation does not, of itself, promote the applicability of a trial's results to situations other than the precise one in which the trial was done. While methodologists and trialists have rightly paid great attention to internal validity, much less has been given to applicability. This narrative review is aimed at those planning to conduct trials, and those aimi...

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

    OpenAIRE

    Shantanu Mehta; Vishal Goyal; Kavita Singh

    2015-01-01

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

  13. What Have We Learned about Trial Design From NIMH-Funded Pragmatic Trials?

    OpenAIRE

    March, John; Kraemer, Helena C.; Trivedi, Madhukar; Csernansky, John; Davis, John; Ketter, Terence A.; Glick, Ira D.

    2010-01-01

    At the 2008 annual meeting of the American College of Neuropsychopharmacology (ACNP), a symposium was devoted to the following question: ‘what have we learned about the design of pragmatic clinical trials (PCTs) from the recent costly long-term, large-scale trials of psychiatric treatments?' in order to inform the design of future trials. In all, 10 recommendations were generated placing emphasis on (1) appropriate conduct of pragmatic trials; (2) clinical, rather than, merely statistical sig...

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

    OpenAIRE

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

    2008-01-01

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

  15. 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; De 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...

  16. 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.

  17. Lessons learned from benchmark orthopaedic trials.

    Science.gov (United States)

    Swiontkowski, Marc F; Agel, Julie

    2012-07-18

    Benchmark trials in orthopaedics are designed to address a question of substantial interest to clinicians and patients. They are also designed to have prospective data collection, an adequate sample size, an appropriate duration of follow-up based on the injury or treatment under study, blinded adjudication of the outcome variables, appropriate statistical analyses, and widespread and effective dissemination of the information learned in the trial. There are multiple lessons to be gleaned from these trials: (1) Identifying an engaging and relevant clinical question will make it easier to identify centers that are willing to participate. (2) Individual site leadership, both of the overall project and at the individual site, is critical to the success of any trial. (3) Not every trial needs to have a randomized design; observational trials can provide data that will impact clinical care. (4) Patients should understand the long-term goals of the project when they are enrolled so that they have a sense of the importance of their role in the study. (5) Follow-up rates that are >90% are possible for orthopaedic trials, but effort and money are required to achieve this. (6) Patients who do not agree to be randomized should be enrolled as subjects in a parallel observational design if it is available. (7) Blinded adjudication of the outcome variables is recommended whenever feasible. (8) Partnership with the academic community is mandatory for the success of industry-funded, phase-3 United States Food and Drug Administration trials. (9) Intention-to-treat analysis and as-treated analysis should be reported. Benchmark orthopaedic trials can and will change clinical practice, but detailed planning must occur to ensure that the results are believable and relevant to the orthopaedic community. These trials are time-consuming and expensive, but with the use of careful initial planning and continued oversight during the trial, Level-I evidence will be obtained and will be useful in clinical care. PMID:22810440

  18. The DiaS trial

    DEFF Research Database (Denmark)

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

    2014-01-01

    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 dialectical behavior therapy with collaborative assessment and management of suicidality......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......-informed supportive psychotherapy, for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder. Both treatments have previously shown effects in this group of patients on suicide ideation and self...

  19. 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 case by introducing new “evidence” that, because of this framing, did not reach “the court.” The...... article ends with a discussion of some implications of the analysis, including that policy making, academic research, and public debates might benefit from more detailed accounts of interests and stakes....

  20. Alien wavelength modeling tool and field trial

    DEFF Research Database (Denmark)

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

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

  1. Homo Economicus and the Salem Witch Trials.

    Science.gov (United States)

    Mixon, Franklin G., Jr.

    2000-01-01

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

  2. 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.

  3. Blinded trials taken to the test

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Forfang, E; Haahr, M T; Als-Nielsen, B; Brorson, S

    2007-01-01

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

  4. The Child and Adolescent Psychiatry Trials Network

    Science.gov (United States)

    March, John S.; Silva, Susan G.; Compton, Scott; Anthony, Ginger; DeVeaugh-Geiss, Joseph; Califf, Robert; Krishnan, Ranga

    2004-01-01

    Objective: The current generation of clinical trials in pediatric psychiatry often fails to maximize clinical utility for practicing clinicians, thereby diluting its impact. Method: To attain maximum clinical relevance and acceptability, the Child and Adolescent Psychiatry Trials Network (CAPTN) will transport to pediatric psychiatry the practical…

  5. 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 ...

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

    Science.gov (United States)

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

    2015-01-01

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

  7. Why are clinical trials necessary in India?

    Directory of Open Access Journals (Sweden)

    Subramani Poongothai

    2014-01-01

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

  8. Design and analyses of clinical trials

    International Nuclear Information System (INIS)

    The course will use RTOG studies to illustrate design and analysis issues for phase I, phase II, and phase III trials. The issues discussed will include types of statistical errors, the selection of study endpoints, choice of the appropriate study population, determination of sample sizes, randomization, and plans for statistical analyses. Estimation of the sample sizes will be discussed for both absolute survival (alive or dead) and cause specific failure (local failure). For phase III trials, Data Monitoring Committees are now widely used in multi-centered trials. Their main purpose is to determine if there are sufficient evidence to terminate a study for efficacy or safety reasons. The results of two such terminated trials will be used to illustrate the DMC's function. The question of when should a trial be reported at medical meeting and in the literature will be explored. The emphasis will be on concepts and statistical notations will be kept to a minimum

  9. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

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

  10. Ethics of clinical trials in Nigeria

    Directory of Open Access Journals (Sweden)

    Patrick I Okonta

    2014-01-01

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

  11. Registration of randomized clinical trials - a challenge

    DEFF Research Database (Denmark)

    Østervig, Rebecca; Sonne, Asger; Rasmussen, L S

    2015-01-01

    BACKGROUND: Registration of interventional studies is necessary according to the Declaration of Helsinki but implementation has been a challenge for many journals. Acta Anaesthesiologica Scandinavica (Acta) requires registration for studies conducted after January 1(st) 2010. We aimed to assess the...... proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... registered when it could be verified that patient enrolment was started after registration in a trial registry. RESULTS: We identified 200 RCTs. Dates for patient enrolment were not specified in 51 (25.5%). The proportion of correctly registered trials increased significantly from 17.1% (19/111) for trials...

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

    Science.gov (United States)

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

    2009-04-01

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

  13. Obtaining evidence by a single well-powered trial or several modestly powered trials.

    Science.gov (United States)

    IntHout, Joanna; Ioannidis, John Pa; Borm, George F

    2016-04-01

    There is debate whether clinical trials with suboptimal power are justified and whether results from large studies are more reliable than the (combined) results of smaller trials. We quantified the error rates for evaluations based on single conventionally powered trials (80% or 90% power) versus evaluations based on the random-effects meta-analysis of a series of smaller trials. When a treatment was assumed to have no effect but heterogeneity was present, the error rates for a single trial were increased more than 10-fold above the nominal rate, even for low heterogeneity. Conversely, for meta-analyses on a series of trials, the error rates were correct. When selective publication was present, the error rates were always increased, but they still tended to be lower for a series of trials than single trials. We conclude that evidence of efficacy based on a series of (smaller) trials, may lower the error rates compared with using a single well-powered trial. Only when both heterogeneity and selective publication can be excluded, a single trial is able to provide conclusive evidence. PMID:23070590

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

    OpenAIRE

    Courneya Kerry S

    2010-01-01

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

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

    DEFF Research Database (Denmark)

    Dal-Ré, Rafael; Moher, David; Gluud, Christian; Treweek, Shaun; Demotes-Mainard, Jacques; Carné, Xavier

    2011-01-01

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

  16. Cancer screening trials: nuts and bolts.

    Science.gov (United States)

    Prorok, Philip C; Marcus, Pamela M

    2010-06-01

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

  17. Justifying clinical trials for porcine islet xenotransplantation.

    Science.gov (United States)

    Ellis, Cara E; Korbutt, Gregory S

    2015-01-01

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

  18. Biomarkers for Alzheimer's disease therapeutic trials.

    Science.gov (United States)

    Hampel, Harald; Wilcock, Gordon; Andrieu, Sandrine; Aisen, Paul; Blennow, Kaj; Broich, K; Carrillo, Maria; Fox, Nick C; Frisoni, Giovanni B; Isaac, Maria; Lovestone, Simon; Nordberg, Agneta; Prvulovic, David; Sampaio, Christina; Scheltens, Philip; Weiner, Michael; Winblad, Bengt; Coley, Nicola; Vellas, Bruno

    2011-12-01

    The development of disease-modifying treatments for Alzheimer's disease requires innovative trials with large numbers of subjects and long observation periods. The use of blood, cerebrospinal fluid or neuroimaging biomarkers is critical for the demonstration of disease-modifying therapy effects on the brain. Suitable biomarkers are those which reflect the progression of AD related molecular mechanisms and neuropathology, including amyloidogenic processing and aggregation, hyperphosphorylation, accumulation of tau and neurofibrillary tangles, progressive functional, metabolic and structural decline, leading to neurodegeneration, loss of brain tissue and cognitive symptoms. Biomarkers should be used throughout clinical trial phases I-III of AD drug development. They can be used to enhance inclusion and exclusion criteria, or as baseline predictors to increase the statistical power of trials. Validated and qualified biomarkers may be used as outcome measures to detect treatment effects in pivotal clinical trials. Finally, biomarkers can be used to identify adverse effects. Questions regarding which biomarkers should be used in clinical trials, and how, are currently far from resolved. The Oxford Task Force continues and expands the work of our previous international expert task forces on disease-modifying trials and on endpoints for Alzheimer's disease clinical trials. The aim of this initiative was to bring together a selected number of key international opinion leaders and experts from academia, regulatory agencies and industry to condense the current knowledge and state of the art regarding the best use of biological markers in Alzheimer's disease therapy trials and to propose practical recommendations for the planning of future AD trials. PMID:21130138

  19. 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

  20. Function: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Shakuri Seyed Kazem

    2015-03-01

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

  1. 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

  2. Eosinophilic esophagitis: trials and tribulations.

    Science.gov (United States)

    Allen, Katrina J; Heine, Ralf G

    2011-08-01

    Eosinophilic esophagitis (EE) is a recently recognized form of pan-esophagitis, which is characterized by the presence of at least 15 eosinophils per high power field on esophageal histology. EE is closely associated with atopic disorders and occurs predominantly in male patients. Young children are more likely to be sensitized to food allergens whilst aeroallergen sensitization predominates in older children and adults--a pattern reminiscent of the "atopic march". EE presents with a diverse range of gastrointestinal symptoms, including regurgitation, vomiting, feeding difficulties or refusal in infancy, in addition to dysphagia and food bolus impaction in older children and adults. The diagnosis may also be ascertained incidentally in patients undergoing gastroscopy for other suspected gastrointestinal conditions, such as gastroesophageal reflux disease or celiac disease. Complications mainly relate to subepithelial remodeling and fibrosis which may result in dysmotility, dysphagia and esophageal strictures. The proportion of EE patients at risk of these complications is unknown due to a paucity of data on the natural history of EE. There are only few randomized controlled trials assessing the efficacy of treatment modalities for EE, which currently either involve food allergen elimination or use of swallowed aerosolized corticosteroids. This article aims to discuss the complex issues of the diagnosis and long-term management that confront clinicians who care for children with EE. PMID:21415771

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

    Directory of Open Access Journals (Sweden)

    Scardino Peter T

    2009-03-01

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

  4. Pragmatic design in randomized controlled trials.

    Science.gov (United States)

    Purgato, M; Barbui, C; Stroup, S; Adams, C

    2015-01-01

    At more than 10 years after the paper by Hotopf and colleagues regarding pragmatic trials in psychiatry, the field has evolved and is evolving further. There have been many developments in our understanding of what pragmatism really means, and excellent examples of truly pragmatic trials in psychiatry are currently available. Funders have helped encourage more emphasis on the need for such studies, but 'local' and trans-national regulations could help more. Consumers of the evidence should have a greater voice in generating the research agenda and, as this happens, the questions generated are more likely to be answered by a pragmatic approach to trials. PMID:25065958

  5. Analysis of the second Field trial

    OpenAIRE

    Iglesias, Eva Marcos; Pellegrino, Massimiliano; Carl, Michael; García-Martínez, Mercedes; Mesa-Lao, Bartolomé; Underwood, Nancy

    2014-01-01

    In this work package, we evaluate the CasMaCat workbench in eld trials to study the use of the workbench in a real-world environment. We will also integrate the workbench into com- munity translation platforms and collect user activity data from both eld trials and volunteer translators. This Deliverable covers Tasks 6.1 and 6.2. Task 6.1: Three eld trials at a translation agency (Celer Soluciones SL)to evaluate the CasMaCat workbench in a real-world professional translat...

  6. THE RIGHT TO A FAIR TRIAL

    OpenAIRE

    FLORICA BRASOVEANU

    2012-01-01

    In the determination of his civil rights and obligations or of any criminal charge against him, everyone is entitled to a fair and public hearing within a reasonable time by an independent and impartial tribunal established by law. The right to fair trial is seen as an essential right in all countries respecting the rule of law. A trial in these countries that is deemed unfair will typically be restarted, or its verdict quashed. The right to a fair trial is explicitly proclaimed in Article 10...

  7. 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

  8. 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

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

    OpenAIRE

    Bell, Stuart A; Tudur Smith, Catrin

    2014-01-01

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

  10. 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

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

    International Nuclear Information System (INIS)

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

  12. Nutrients, foods, dietary patterns and telomere length: Update of epidemiological studies and randomized trials.

    Science.gov (United States)

    Freitas-Simoes, Tania-Marisa; Ros, Emilio; Sala-Vila, Aleix

    2016-04-01

    Identifying simple strategies to prevent or delay age-associated pathologies is a major public health concern. Attrition of telomeres, chromatin structures that help maintain genome stability, leads to cell death or senescence. Thus telomere length is a reliable hallmark of biological aging and the risk of developing age-related chronic diseases through common oxidation and inflammation mechanisms. Variability in telomere shortening that is independent of chronological age suggests that it is a modifiable factor, which may be explained in part by lifestyle variables such as smoking, adiposity, physical exercise, and diet. Here we summarize data from published studies focused on nutrition (nutrients, foods, and dietary patterns) and telomere length. Research on the topic is incipient and most data comes from epidemiologic studies, often cross-sectional in design. Consistent with well-known evidence of benefit or harm for chronic age-related diseases, dietary antioxidants and consumption of antioxidant-rich, plant-derived foods help maintain telomere length. In contrast, total and saturated fat intake and consumption of refined flour cereals, meat and meat products, and sugar-sweetened beverages relate to shorter telomeres. Data on alcohol and dairy products is controversial. There is evidence that adherence to the Mediterranean diet is associated with longer telomeres. Randomized clinical trials are limited to seafood-derived long-chain n-3 polyunsaturated fatty acids, with promising results. To fill the many gaps in our knowledge of the aging process and confirm nutrition as a useful tool to counteract biological aging more research is warranted, particularly observational studies using repeated measurements of telomere length and randomized trials of foods and dietary patterns with sequential telomere analyses. PMID:26975532

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

    Directory of Open Access Journals (Sweden)

    A. S. Hedayat

    2012-07-01

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

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

    Scientific Electronic Library Online (English)

    Daniela, HESSE; Clarissa Calil, BONIFCIO; Camila de Almeida Brando, GUGLIELMI; Carolina da, FRANCA; Fausto Medeiros, MENDES; Daniela Prcida, 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

  15. Randomised trials for the Fitbit generation

    OpenAIRE

    Dempsey, Walter; Liao, Peng; Klasnja, Pedja; Nahum-Shani, Inbal; Murphy, Susan A.

    2015-01-01

    Data from activity trackers and mobile phones can be used to craft personalised health interventions. But measuring the efficacy of these “treatments” requires a rethink of the traditional randomised trial.

  16. 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

  17. Calculating Outsourcing Strategies and Trials of Strength

    DEFF Research Database (Denmark)

    Christensen, Mark; Skærbæk, Peter; Tryggestad, Kjell

    outsourcing strategies during a series of trials of strength, 2. develops the concept of ‘trial of strength’ for accounting and organization research by showing how ‘the rules of the game’ for the trials of strength can become challenged and controversial, 3. shows that, in addition to the pervasive role of...... demonstrates the power of projects and their use of accounting calculation. We study how the two options emerged and were valued differently by the supra-national outsourcing program and the local Defense projects over 22 years and how that valuation process involved accounting. Drawing on Actor-Network Theory...... we show how the two strategic options emerged and were pitted against each other in what Latour and Callon describe as ‘trials of strength’. The contribution of the paper is in four parts: 1. highlights how accounting inscriptions take part in formulating, evaluating and advancing different...

  18. Smart Technology in Lung Disease Clinical Trials.

    Science.gov (United States)

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

    2016-01-01

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

  19. Problems for clinical trial with fast neutrons

    International Nuclear Information System (INIS)

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

  20. 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.

  1. Survival in prostate cancer prevention trial detailed

    Science.gov (United States)

    In the NCI-sponsored Prostate Cancer Prevention Trial, initial findings from a decade ago showed that the drug finasteride significantly reduced the risk of prostate cancer, but among those who did develop prostate cancer, paradoxically, the drug was asso

  2. TREATMENT OF LEAD EXPOSED CHILDREN TRIAL

    Science.gov (United States)

    The Treatment of Lead-exposed Children (TLC) clinical trial compared the effect of lead chelation with succimer to placebo therapy. Outcomes included IQ, neuropsychological function, behavior, physical growth and blood pressure three years after initiation of treatment. Residenti...

  3. Mountain rescue stretchers: usability trial.

    Science.gov (United States)

    Hignett, Sue; Willmott, Joseph Wayne; Clemes, Stacy

    2009-01-01

    In the UK mountain rescues are carried out by highly trained volunteers in all weather conditions and at any time of the day/night. They interface with other services when they hand over the casualty to either land or air ambulances. The design of the stretcher is important to the safety of both the volunteers and casualties. This paper reports a usability trial to evaluate the features of mountain rescue stretchers and identify characteristics for future design. Two mountain rescue teams in the English Lake District participated in a five week field experiment. Data were collected using postural analysis with Rapid Entire Body Analysis, Body Part Discomfort Surveys, Rated Perceived Exertion and focus groups to compare the performance of four stretchers: Split Thomas, Ferno Titan, MacInnes mark 6 and MacInnes mark 7. None of the stretchers had an overall advantage, with benefits for some features counterbalanced by disadvantages resulting from others. All the stretchers produced shoulder discomfort with the Split Thomas and MacInnes 6 lowering the postural risks through the use of skids/wheel in the carrying phase. The key design features for future MR stretchers include: reduced unloaded weight (e.g. light weight materials and mesh platforms); undercarriage system to reduce the carrying load; adjustable handles at the front and back positions; flexible carrying system with an optional harness attachment; ease of assembly in adverse environmental conditions; large carrying capacity. It is suggested that military emergency evacuation should be considered in addition to mountain rescue tasks to identify a larger commercial market for development. PMID:20037233

  4. Cancer Screening Trials: Nuts and Bolts

    OpenAIRE

    Prorok, Philip C; Marcus, Pamela M

    2010-01-01

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

  5. The Hawthorne Effect: a randomised, controlled trial

    OpenAIRE

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

    2007-01-01

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

  6. Strength of Mock-up Trial Grout

    DEFF Research Database (Denmark)

    Sørensen, Eigil V.

    The present report describes tests carried out on samples taken and cast during the execution of a mock-up trial placement of the high performance grout MASTERFLOW 9500 on January 21, 2009.......The present report describes tests carried out on samples taken and cast during the execution of a mock-up trial placement of the high performance grout MASTERFLOW 9500 on January 21, 2009....

  7. Trials within trials? Researcher, funder and ethical perspectives on the practicality and acceptability of nesting trials of recruitment methods in existing primary care trials

    Directory of Open Access Journals (Sweden)

    Delaney Brendan

    2010-04-01

    Full Text Available Abstract Background Trials frequently encounter difficulties in recruitment, but evidence on effective recruitment methods in primary care is sparse. A robust test of recruitment methods involves comparing alternative methods using a randomized trial, 'nested' in an ongoing 'host' trial. There are potential scientific, logistical and ethical obstacles to such studies. Methods Telephone interviews were undertaken with four groups of stakeholders (funders, principal investigators, trial managers and ethics committee chairs to explore their views on the practicality and acceptability of undertaking nested trials of recruitment methods. These semi-structured interviews were transcribed and analysed thematically. Results Twenty people were interviewed. Respondents were familiar with recruitment difficulties in primary care and recognised the case for 'nested' studies to build an evidence base on effective recruitment strategies. However, enthusiasm for this global aim was tempered by the challenges of implementation. Challenges for host studies included increasing complexity and management burden; compatibility between the host and nested study; and the impact of the nested study on trial design and relationships with collaborators. For nested recruitment studies, there were concerns that host study investigators might have strong preferences, limiting the nested study investigators' control over their research, and also concerns about sample size which might limit statistical power. Nested studies needed to be compatible with the main trial and should be planned from the outset. Good communication and adequate resources were seen as important. Conclusions Although research on recruitment was welcomed in principle, the issue of which study had control of key decisions emerged as critical. To address this concern, it appeared important to align the interests of both host and nested studies and to reduce the burden of hosting a recruitment trial. These findings should prove useful in devising a programme of research involving nested studies of recruitment interventions.

  8. Phase 1 Trials in Pancreatic Cancer

    Directory of Open Access Journals (Sweden)

    Esther Yu

    2014-07-01

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

  9. Rationale for the tinnitus retraining therapy trial

    OpenAIRE

    Craig Formby; Roberta Scherer

    2013-01-01

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

  10. 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...

  11. The Moral Trial: On Ethics and Economics

    OpenAIRE

    Lanteri, Alessandro

    2008-01-01

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

  12. 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...

  13. Consumers Trial Buying Process of Service Innovation.

    OpenAIRE

    Peltonen, Laura

    2013-01-01

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

  14. Clinical trials design: protocols and endpoints.

    Science.gov (United States)

    Wyllie, M G

    2000-10-01

    Over the last decade there has been a proliferation in clinical trials to test agents for the treatment of erectile dysfunction (ED). Many aspects of clinical trials design and conduct and guidelines for future conduct have been the subject of a recent comprehensive review (Rosen R et al. In: Proceedings of the 1st International Consultation on Erectile Dysfunction 1999). The present article attempts to extend that analysis from trials that focus purely on symptomatic improvement of ED to trials relevant to the management of the ED patient in the community. Although the regulatory approval process accounts for the bulk of the clinical trials undertaken, studies are also initiated for concept testing, post-marketing surveillance and for promotional and/or pricing reasons. The trial design can be dependent on which of the above objectives is being served. However, there are also many common features that are summarized below; the major focus is placed on regulatory-standard or 'pivotal' studies. International Journal of Impotence Research (2000) 12, Suppl 4, S53-S58. PMID:11035387

  15. Survival After Solid Cancers in Antithrombotic Trials.

    Science.gov (United States)

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

    2015-09-15

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

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

    DEFF Research Database (Denmark)

    Wildt, Signe; Krag, Aleksander; Gluud, Liselotte

    2011-01-01

    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...... 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...

  17. 21 CFR 886.1415 - Ophthalmic trial lens frame.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens frame. 886.1415 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1415 Ophthalmic trial lens frame. (a) Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for...

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

    DEFF Research Database (Denmark)

    Dellson, Pia; Nilbert, Mef; Carlsson, Christina

    2016-01-01

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

  19. 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

  20. 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.

  1. 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

  2. Mind the gap: An empirical study of post-trial access in HIV biomedical prevention trials.

    Science.gov (United States)

    Haire, Bridget; Jordens, Christopher

    2015-08-01

    The principle of providing post-trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post-trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, sponsors, and regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post-trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post-trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account. PMID:26193849

  3. 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.

  4. Quality of clinical trials: A moving target.

    Science.gov (United States)

    Bhatt, Arun

    2011-10-01

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

  5. 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.

  6. Quality of clinical trials: A moving target

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2011-01-01

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

  7. Recent trial results of an LWIR polarimeter

    Science.gov (United States)

    Connor, Barry; Carrie, Iain

    2009-05-01

    The aim of this paper is to describe the results of various trials involving a high-resolution thermal imager that has been designed to be sensitive to polarised radiation. Polarisation has the potential to discriminate man-made objects and disturbed earth from background clutter. Polarisation combined with conventional thermal imaging within the one camera offers the potential to significantly reduce false alarms in surveillance and detection applications. The camera used during the trials is a technology demonstrator developed by Thales Optronics, UK. The camera operates in the longwave infra red and has a QWIP polarisation-sensitive detector. The results presented in this paper include recent trials in the UK and USA. The aim of the trials was to assess the utility in using a LWIR polarimeter for detection of difficult objects from background clutter. Thermal and polarised images were captured and processed in order to detect anomalies. Several polarisation-based discriminative imaging techniques are applied to trials imagery. The effect of the diurnal cycle on the effectiveness of polarisation for object discrimination will be assessed.

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

    OpenAIRE

    Molyneux Andrew J; Darsaut Tim E; Raymond Jean

    2011-01-01

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

  9. 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

  10. Problems and alternatives to classical randomized trials

    International Nuclear Information System (INIS)

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

  11. 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.

  12. Cooperative Group Trials in the Community Setting.

    Science.gov (United States)

    Lloyd Wade, James; Petrelli, Nicholas J; McCaskill-Stevens, Worta

    2015-10-01

    Over the last 40 years the National Cancer Institute (NCI) has created a vibrant public-private partnership for the implementation of NCI-sponsored cooperative group (Network) clinical trials throughout the United States and Canada. Over these four decades, the cancer clinical trials process has become more complex more precise and more resource intensive. During this same time period, financial resources to support the NCI community research initiative have become more constrained. The newest manifestation of NCI-sponsored community based cancer clinical trial research, known as the National Community Oncology Research Program (NCORP) began initial operation August 1, 2014. We describe several key strategies that community sites may use to not only be successful but to thrive in this new financially austere research environment. PMID:26433550

  13. Government initiatives in autism clinical trials.

    Science.gov (United States)

    Vitiello, Benedetto; Wagner, Ann

    2004-01-01

    Randomized clinical trials remain the most valid method of testing the efficacy and safety of treatments. While efforts to elucidate the genetic and neurodevelopmental bases of autism are underway, clinicians and families are in need of scientifically valid information on how to best treat patients with autism. The effectiveness of many interventions currently used in communities has not been adequately tested. Given the high public health relevance of autism treatment research and the low interest of the pharmaceutical industry in autism, the role of the National Institutes of Health in supporting this research is paramount. Among recently launched initiatives in autism clinical trials, there are the Research Units on Pediatric Psychopharmacology Autism Network and the network of centers for Studies to Advance Autism Research and Treatment. These and other government activities in the area of autism clinical trials are here briefly reviewed. PMID:14999177

  14. The future of neonatal therapeutic trials.

    Science.gov (United States)

    Stephenson, T; Budge, H

    2006-07-01

    Neonatology has undoubtedly benefited from clinical trials. Nevertheless, more treatments based on inadequate experimental evidence are given than those that are supported by a validated evidence base. Clinicians seeking the basis for their current and future clinical practice are faced with challenges in the shadow of recent UK legislation and government recommendations. All patients must be protected from inappropriate research, but the benefits of regulations must be appropriately balanced with those of properly conducted clinical trials. It is ethically difficult both to persist with treatments of unproven benefit and unknown harm and to deny infants potentially valuable therapies. It is important that trials are conducted within the new legislative framework, but their future may rest with innovative solutions and the determination of all involved in the process. PMID:16790737

  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. 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

  17. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

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

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

    Directory of Open Access Journals (Sweden)

    Ameer Aslam

    2013-01-01

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

  19. Future of Clinical Trials in Nepal

    Directory of Open Access Journals (Sweden)

    Brijesh Sathian

    2011-07-01

    Full Text Available Nowadays the outputand rewardsof 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 countrys experiences. I recommend that properly trained clinical trial experts from developed countries should conduct some workshops on the design, conduct and ethical issues in clinical trials to terminate the research misconduct in developing countries.

  20. General pretrial publicity in sexual assault trials.

    Science.gov (United States)

    Woody, William Douglas; Viney, Wayne

    2007-10-01

    An experiment was designed to explore effects of general pretrial publicity in sexual assault trials. Four pretrial publicity conditions (no publicity, neutral news media, prodefendant, and antidefendant) in the form of simulated newspaper articles were presented to 356 participants. Participants subsequently read a mock rape trial summary and reported verdicts. In the absence of pretrial publicity related to sexual assault, women were more likely than men to convict the defendant, but the presence of sexual assault pretrial publicity in any form eliminated sex differences in conviction rates. PMID:18175495

  1. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

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

  2. 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.

  3. The Statistics of Phase 0 Trials

    OpenAIRE

    Rubinstein, Larry V.; Steinberg, Seth M.; Kummar, Shivaani; Kinders, Robert; PARCHMENT, RALPH E.; Murgo, Anthony J; Tomaszewski, Joseph E.; Doroshow, James H.

    2010-01-01

    The PD-driven phase 0 trial is a new form, designed to be a first-in-man study, often of a new agent, conducted to assess drug effect on a molecular target, by means of a pharmacodynamic (PD) assay, in a very small number (10–15) of patients. Such a study is meant to be a proof of principle trial to determine whether the agent yields the PD effect predicted by pre-clinical studies. The dosage is meant to be pharmacologically active, but neither toxic nor likely to yield clinical benefit. Such...

  4. 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...

  5. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

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

  6. Not well known and long time been lost sight of. The great accidents of uranium hexafluoride in the world; Peu connus et longtemps occultes. Les grands accidents d'hexafluorure d'uranium dans le monde

    Energy Technology Data Exchange (ETDEWEB)

    Andurand, R

    2004-11-15

    This review tackles the accidents of uranium hexafluorides in the world. This study is made in three parts. This first part explains what is uranium hexafluoride, gives its characteristics, the problems of storage, the tests of resistance of the containers before coming to the accidents themselves. (N.C.)

  7. François Hollande is by no means certain to win the French Presidential election. He may yet fall foul of France’s well-known ‘Frontrunner Syndrome’, as Sarkozy’s fightback begins.

    OpenAIRE

    Murray, Rainbow

    2012-01-01

    In the run up to France’s presidential election on 22 April opinion polls place President Nicolas Sarkozy on the back foot against the Socialist candidate François Hollande. Yet Rainbow Murray argues that the contest is far from over yet. Sarkozy can draw on his recent experience on the European and world stages, and Hollande must overcome historical trends where election frontrunners in France see their support fall dramatically in the immediate run up to Presidential elections.

  8. On the appearance of polyadenylate polymerase activity in blood serum of animals exposed to a short-term influence by N,N'-ethylenethiourea, a well known hepatic carcinogen: a preliminary report.

    Science.gov (United States)

    Kuznetsov, D A; Zavijalov, N V

    1987-01-01

    Daily intragastric administration of a carcinogen N,N'-ethylenethiourea (ETU) (85 mg/kg body wt, congruent to 0.1 DL50) leads to significant polyadenylate polymerase (PAP) activity in rat blood serum by the 10th day of experiment. A similar course of N,N'-ethyleneurea (EU) fails to affect this enzyme activity in the blood. Also, PAP activity is not registered in the blood serum of intact rats. PMID:2433026

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

    Science.gov (United States)

    Endicott, Frank S.

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

  10. Differences in trial knowledge and motives for participation among cancer patients in phase 3 clinical trials.

    Science.gov (United States)

    Godskesen, T M; Kihlbom, U; Nordin, K; Silén, M; Nygren, P

    2016-05-01

    While participants in clinical oncology trials are essential for the advancement of cancer therapies, factors decisive for patient participation have been described but need further investigation, particularly in the case of phase 3 studies. The aim of this study was to investigate differences in trial knowledge and motives for participation in phase 3 clinical cancer trials in relation to gender, age, education levels and former trial experience. The results of a questionnaire returned from 88 of 96 patients (92%) were analysed using the Mann-Whitney U-test. There were small, barely relevant differences in trial knowledge among patients when stratified by gender, age or education. Participants with former trial experience were less aware about the right to withdraw. Male participants and those aged ≥65 years were significantly more motivated by a feeling of duty, or by the opinions of close ones. Men seem more motivated than women by external factors. With the awareness that elderly and single male participants might be a vulnerable group and participants with former trial experience are less likely to be sufficiently informed, the information consent process should focus more on these patients. We conclude that the informed consent process seems to work well, with good results within most subgroups. PMID:25904313

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

    Science.gov (United States)

    de Xivry J-J, Orban; de Xivry, Jean-Jacques Orban

    2013-01-01

    Each task requires a specific motor behavior that is tuned to task demands. For instance, writing requires a lot of accuracy while clapping does not. It is known that the brain adjusts the motor behavior to different task demands as predicted by optimal control theory. In this study, the mechanism of this reoptimization process is investigated by varying the accuracy demands of a reaching task. In this task, the width of the reaching target (0.5 or 8 cm) was varied either on a trial-to-trial basis (random schedule) or in blocks (blocked schedule). On some trials, the hand of the subjects was clamped to a rectilinear trajectory that ended 2 cm on the left or right of the target center. The rejection of this perturbation largely varied with target width in the blocked schedule but not in the random schedule. That is, subjects exhibited different motor behavior in the different schedules despite identical accuracy demands. Therefore, while reoptimization has been considered immediate and automatic, the differences in motor behavior observed across schedules suggest that the reoptimization of the motor behavior is neither happening on a trial-by-trial basis nor obligatory. The absence of trial-to-trial mechanisms, the inability of the brain to adapt to two conflicting task demands and the existence of a switching cost are discussed as possible sources of the non-optimality of motor behavior during the random schedule. PMID:23776593

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

    OpenAIRE

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

    2015-01-01

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

  13. Chelation therapy after the Trial to Assess Chelation Therapy: results of a unique trial

    OpenAIRE

    Maria D. Avila; Escolar, Esteban; Lamas, Gervasio A.

    2014-01-01

    Purpose of review EDTA chelation therapy has been in off-label use for the treatment of atherosclerosis. We review the results of the first large-scale randomized trial of this treatment. Recent findings The trial to assess chelation therapy was a $30 million National Institutes of Health-funded study of the safety and efficacy of EDTA-based chelation infusions in 1708 post-myocardial infarction (MI) patients. The trial to assess chelation therapy demonstrated a significant (P = 0.035) 18% re...

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

    Directory of Open Access Journals (Sweden)

    Veerus Piret

    2005-04-01

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

  15. Blast densification trials for oilsands tailings

    Energy Technology Data Exchange (ETDEWEB)

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

    2010-07-01

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

  16. Stroke Prevention Trials in Sickle Cell Anemia

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2006-06-01

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

  17. Gone fishing in a fluid trial

    DEFF Research Database (Denmark)

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

    2016-01-01

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

  18. Raw data from clinical trials: within reach?

    Science.gov (United States)

    Doshi, Peter; Goodman, Steven N; Ioannidis, John P A

    2013-12-01

    Making raw data from clinical trials widely publically available should reduce selective reporting biases and enhance the reproducibility of and trust in clinical research. The optimal procedures for data sharing are hotly debated. Some of the caveats and limitations in proposed data-sharing policies are potentially restrictive, and we argue in favor of more widespread availability of data from clinical research. PMID:24295825

  19. Winding trials for ITER toroidal filed coils

    International Nuclear Information System (INIS)

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

  20. 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)

  1. Review of the optic neuritis treatment trial

    International Nuclear Information System (INIS)

    The Optic Neuritis Treatment Trial (ONTT) is a multicenter controlled clinical trial. The primary objective of this trial is to assess the efficacy of corticosteroids in the treatment of optic neuritis. Treatment with intravenous methylprednisolone resulted in a more rapid return of the visual function to normal. Oral prednisone alone was associated with a significantly increased risk of recurrent optic neuritis. The trial also provided invaluable information about the clinical profile of optic neuritis and its relationship to Multiple Sclerosis (MS). At 6 months after the initial optic neuritis attack, a 12-month follow-up of patients was begun and the data collected during this period indicated that visual acuity was more than 20/20 in 69%, 20/40 in 93%, and 20/200 or less in only 3% of the patients. The risk of MS within 10 years after the first episode of optic neuritis was 56% among patients who were found to have had one or more characteristic white-matter lesions at baseline, as compared to only 22% for patients who had no observable lesions at baseline. (author)

  2. 7 CFR 1755.3 - Field trials.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Field trials. 1755.3 Section 1755.3 Agriculture... considered for acceptance by RUS or when a previously accepted item has been subjected to such major..., high probability of lightning damage, etc., for which the product is being evaluated. The material...

  3. Trial access to Cambridge University Press ebooks

    CERN Multimedia

    CERN Library

    2011-01-01

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

  4. Cluster Randomized Trials with Treatment Noncompliance

    Science.gov (United States)

    Jo, Booil; Asparouhov, Tihomir; Muthen, Bengt O.; Ialongo, Nicholas S.; Brown, C. Hendricks

    2008-01-01

    Cluster randomized trials (CRTs) have been widely used in field experiments treating a cluster of individuals as the unit of randomization. This study focused particularly on situations where CRTs are accompanied by a common complication, namely, treatment noncompliance or, more generally, intervention nonadherence. In CRTs, compliance may be…

  5. Preparedness for AIDS vaccine trials in India.

    Science.gov (United States)

    Excler, Jean-Louis; Kochhar, Sonali; Kapoor, Sushma; Das, Sweta; Bahri, Jyoti; Ghosh, Meenakshi Datta; Ganguly, N K; Nayyar, Anjali; Chataway, Mark

    2008-06-01

    India bears a heavy disease burden of HIV/AIDS infected and affected people. A safe, effective and accessible preventive AIDS vaccine, used along with other preventive interventions, is urgently needed to stem the epidemic. This review highlights the extensive preparedness activities undertaken from 2002 by the International AIDS Vaccine Initiative (IAVI), its Indian government and non government partners with the Indian scientific, political, media and community stakeholders and the capacity building process, before the conduct of the first ever AIDS vaccine trials in India in early 2005. Issues addressed included mistrust of clinical research due to past history of some unethical trials, transparency, community involvement, stigma and discrimination, provision for care and treatment of participants, informed consent, gender considerations, approval process, and operational aspects. The strong political support along with preparedness activities led to the successful conduct of AIDS vaccine trials enrolling equitably healthy women and men from all sections of society. This has paved the way for future vaccine trials in the country. PMID:18765870

  6. 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 ...

  7. 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)

  8. 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)

  9. Using e-technologies in clinical trials.

    Science.gov (United States)

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

    2015-11-01

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

  10. RTOG: Updated results of randomized trials

    International Nuclear Information System (INIS)

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

  11. 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)

  12. 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 β-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 β-blockers and/or having complementary modes of action.Keywords: intraocular pressure, glaucoma progression, clinical trials, drug development, aqueous humor dynamics, antihypertensive

  13. The Radiation oncology practice standards trial

    International Nuclear Information System (INIS)

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

  14. 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.; 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...

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

    OpenAIRE

    2011-01-01

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

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

    OpenAIRE

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

    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...

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

    OpenAIRE

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

    1999-01-01

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

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

    OpenAIRE

    Butow Phyllis N; Crossing Sally; Barratt Alexandra L; Dear Rachel F; Hanson Susan; Tattersall Martin HN

    2011-01-01

    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. Consu...

  19. Trial wave functions for High-Pressure Metallic Hydrogen

    OpenAIRE

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

    2007-01-01

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

  20. Contribution of clinical trials to gross domestic product in Hungary

    OpenAIRE

    Kaló, Zoltán; Antal, János; Pénzes, Miklós; Pozsgay, Csilla; Szepezdi, Zsuzsanna; Nagyjánosi, László

    2014-01-01

    Aim To determine the contribution of clinical trials to the gross domestic product (GDP) in Hungary. Methods An anonymous survey of pharmaceutical companies and clinical research organizations (CROs) was conducted to estimate their clinical trial-related employment and revenues. Clinical trial documents at the National Institute of Pharmacy (NIP) were analyzed to estimate trial-related revenues at health care institutions and the value of investigational medical products (IMPs) based on avoid...

  1. Cross-System Evaluation of Clinical Trial Search Engines

    OpenAIRE

    Jiang, Silis Y.; Weng, Chunhua

    2014-01-01

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

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

    Science.gov (United States)

    Schools Council, London (England).

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

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

    International Nuclear Information System (INIS)

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

  4. The Use of Electronic Data Capture Tools in Clinical Trials: Web-Survey of 259 Canadian Trials

    OpenAIRE

    El Emam, Khaled; Jonker, Elizabeth; Sampson, Margaret; KRLEŽA-JERIĆ, KARMELA; Neisa, Angelica

    2009-01-01

    Background Electronic data capture (EDC) tools provide automated support for data collection, reporting, query resolution, randomization, and validation, among other features, for clinical trials. There is a trend toward greater adoption of EDC tools in clinical trials, but there is also uncertainty about how many trials are actually using this technology in practice. A systematic review of EDC adoption surveys conducted up to 2007 concluded that only 20% of trials are using EDC systems, but ...

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

    Science.gov (United States)

    2013-01-01

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

  6. Media reporting of tenofovir trials in Cambodia and Cameroon

    Directory of Open Access Journals (Sweden)

    Wong Elaine

    2005-08-01

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

  7. Rare cancer trial design: lessons from FDA approvals.

    Science.gov (United States)

    Gaddipati, Himabindu; Liu, Ke; Pariser, Anne; Pazdur, Richard

    2012-10-01

    A systematic analysis of clinical trials supporting rare cancer drug approvals may identify concepts and terms that can inform the effective design of prospective clinical trials for rare cancers. In this article, using annual incidence ≤6 of 100,000 individuals to define "rare cancer," we identified clinical trials for rare cancers, supporting U.S. Food and Drug Administration (FDA) drug approvals for rare cancer indications between December 1987 and May 2011. We characterized each selected trial for study design, sample size, primary efficacy endpoints, and statistical comparisons. We also profiled trials with regard to type of submission, review designation, and approval type. Our results indicated that, of 99 trials that supported the approvals of 45 drugs for 68 rare cancer indications, one third of these trials were randomized; 69% of approvals relied on objective response rate as the primary efficacy endpoint; and 63% were based on a single trial. Drugs granted accelerated approval appeared more likely to be associated with postmarketing safety findings, relative to drugs approved under the regular approval. Data collected across clinical trials were robust: Use of different lower incidence rates in analyzing these trials did not have effects on trial characteristics. The absolute number of drug approvals for rare cancer indications increased markedly over time. We concluded that one third of clinical trials supporting drug approvals for rare cancer indications were randomized, affirming the feasibility and value of randomized trial design to evaluate drugs for rare cancers. Postmarketing safety data may relate to trial design and approval type. An operational definition of "rare cancer" can be useful for the analysis of trial data and for the path toward harmonizing the terminology in the area of clinical research on rare cancers. PMID:22718862

  8. 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 Past ... very emotional." Should You Be Interested in a Clinical Trial People volunteer to take part in clinical trials ...

  9. THE RIGHT TO A FAIR TRIAL

    Directory of Open Access Journals (Sweden)

    FLORICA BRASOVEANU

    2012-05-01

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

  10. 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,...

  11. Prostate Cancer Prevention: Concepts and Clinical Trials.

    Science.gov (United States)

    Hamilton, Zachary; Parsons, J Kellogg

    2016-04-01

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

  12. 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.

  13. Diabetic nephropathy: landmark clinical trials and tribulations.

    Science.gov (United States)

    Chan, Gary C W; Tang, Sydney C W

    2016-03-01

    Diabetic nephropathy remains the most common cause of end-stage renal disease worldwide. The current standard of therapy for diabetic nephropathy involves stringent blood pressure control via blockade of the renin-angiotensin system and control of hyperglycemia. Despite these strategies, diabetic nephropathy is still seen to progress relentlessly. A pressing need for novel therapeutic agents has fueled endless basic science research projects and clinical trials in the quest for a more specific therapy. Throughout the process, only a handful of ancillary agents have shown experimental promise and even fewer have demonstrated an impact in human trials. This review article aims to summarize the available data from landmark studies for the main therapeutic approaches investigated. PMID:25637638

  14. 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.

  15. First clinical trial with iohexol in myelography

    International Nuclear Information System (INIS)

    This is a report of the first clinical trial with iohexol in lumbar myelography. The investigation was carried out as an open, non-comparative study in 30 patients and was part of a mulicentre trial. Iohexol doses of 10 to 15 ml (180 mg I/ml) were used and clinical and laboratory tests were performed before and during 48 h after myelography. Spinal repuncture 6 or 24 h after myelography was done in all patients. Only minor side effects of temporary duration were recorded in 8 patients. No seizures or spikes on EEG were seen. There was no significant increase in CSF parameters such as white cell counts, protein or IgG. (Auth.)

  16. Clinical trials of conformal therapy - physics aspects

    International Nuclear Information System (INIS)

    If Conformal Therapy (CFRT) hadn't existed, physicists would have invented it! So many of the concepts involved are physicist ones: 3-D dose calculation/planning, Beam's-Eye-View, Dose-Volume Histograms, Multileaf Collimators, Computer-Controlled Delivery, Megavoltage Imaging, Optimization, Inverse Planning, Tomotherapy, Biological Modeling, even Protons. All the above developments, many of them involving fairly expensive technology, are on trial. If we wish to be able to use and to continue development of these physicist tools in the future then it has to be demonstrated conclusively that CFRT results in improved clinical outcome. Physicists should therefore be in the front line of planning, executing and evaluating Clinical Trials of Conformal Therapy, by which I mean Randomized, Prospective Phase-III trials i.e. ones that have improved complication-free local control/survival as their endpoint. A prospective, randomized trial to assess the effect of reducing the volume of irradiated normal tissue on acute side-effects in pelvic radiotherapy (93% prostate or bladder ca.) has been carried out at our centre, on 266 patients. In both arms a 3-field, 6 MV x-ray technique was used with identical dose prescriptions; in the conventional arm rectangular fields were employed whereas in the conformal arm the fields were shaped with customized blocks drawn according to the Beam's-Eye-View of the target volume. Substantial differences in normal-tissue volumes (rectum, bladder etc.) were achieved: mean High-Dose Volume (∼ PTV) of 690 cm3 for the conformal technique vs 940 cm3 conventionally. Comprehensive quality-of-life questionnaire were completed before the start of treatment, weekly during and for 3 weeks after the end of treatment and then monthly for a further 2 months. A clear pattern of an increase during followed by a decrease after treatment in symptoms relating to bowel and bladder functions was observed for the patient group as a whole. However, a very extensive analysis has not revealed any significant differences in symptoms, nor in medication prescribed between the two arms. This result is not consistent with the findings of Soffen et al (1992) and by Vijayakumar et al (1993) but these were non-randomized studies. There are many lessons to be learned from the RMT trial e.g. DVH accuracy should be checked beforehand, a standardized symptom-scoring system should also be used (e.g. RTOG). We are about to begin a prospective, randomized trial of dose escalation (64 vs 74 Gy) for prostate cancer and are attempting to broaden this into a Europe-wide multi-centre trial in which the emphasis will be on a sufficient dose difference between the arms rather than on prescribing a given technique for all participants. The future of a great deal of physics research hangs on the outcome of such clinical trials

  17. Annual technical report. PV domestic field trial

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-07-01

    This report describes progress at the first five sites of the UK photovoltaic (PV) domestic field trial. All five sites are generating electricity, but one has not yet been commissioned and two sites are not yet monitoring performance. The BedZED development has roof-mounted PV modules and PV cells installed in sealed double-glazing. Solar slates/tiles have been installed at the Laing Homes development in Montagu Road, where the designer has sought to minimise the visual impact of the PV system on the roofs. At Hunters Moon, PV modules have been retrofitted and some unforeseen difficulties have arisen. PV is an integral part of the roof design at the state-of-the-art low energy development by Integer Houses at Greenfields. Corn Croft uses a British mounting system to facilitate integration of the modules flush with the roof. Installation issues and the progress of the trial are discussed.

  18. The first documented controlled trial in history.

    Science.gov (United States)

    Koren, Gideon

    2015-01-01

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

  19. Rett Syndrome: Reaching for Clinical Trials.

    Science.gov (United States)

    Pozzo-Miller, Lucas; Pati, Sandipan; Percy, Alan K

    2015-07-01

    Rett syndrome (RTT) is a syndromic autism spectrum disorder caused by loss-of-function mutations in MECP2. The methyl CpG binding protein 2 binds methylcytosine and 5-hydroxymethycytosine at CpG sites in promoter regions of target genes, controlling their transcription by recruiting co-repressors and co-activators. Several preclinical studies in mouse models have identified rational molecular targets for drug therapies aimed at correcting the underlying neural dysfunction. These targeted therapies are increasingly translating into human clinical trials. In this review, we present an overview of RTT and describe the current state of preclinical studies in methyl CpG binding protein 2-based mouse models, as well as current clinical trials in individuals with RTT. PMID:25861995

  20. Designing Clinical Trials of Intervention for Mobility Disability: Results from the Lifestyle Interventions and Independence for Elders (LIFE) Pilot Trial

    Science.gov (United States)

    Clinical trials to assess interventions for mobility disability are critically needed, however data for efficiently designing such trials are lacking. Our results are described from the LIFE pilot clinical trial, in which 424 volunteers aged 70-89 years were randomly assigned to one of two intervent...

  1. 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.

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

    International Nuclear Information System (INIS)

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

  3. 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.

  4. OpenTrials: towards a collaborative open database of all available information on all clinical trials.

    Science.gov (United States)

    Goldacre, Ben; Gray, Jonathan

    2016-01-01

    OpenTrials is a collaborative and open database for all available structured data and documents on all clinical trials, threaded together by individual trial. With a versatile and expandable data schema, it is initially designed to host and match the following documents and data for each trial: registry entries; links, abstracts, or texts of academic journal papers; portions of regulatory documents describing individual trials; structured data on methods and results extracted by systematic reviewers or other researchers; clinical study reports; and additional documents such as blank consent forms, blank case report forms, and protocols. The intention is to create an open, freely re-usable index of all such information and to increase discoverability, facilitate research, identify inconsistent data, enable audits on the availability and completeness of this information, support advocacy for better data and drive up standards around open data in evidence-based medicine. The project has phase I funding. This will allow us to create a practical data schema and populate the database initially through web-scraping, basic record linkage techniques, crowd-sourced curation around selected drug areas, and import of existing sources of structured and documents. It will also allow us to create user-friendly web interfaces onto the data and conduct user engagement workshops to optimise the database and interface designs. Where other projects have set out to manually and perfectly curate a narrow range of information on a smaller number of trials, we aim to use a broader range of techniques and attempt to match a very large quantity of information on all trials. We are currently seeking feedback and additional sources of structured data. PMID:27056367

  5. Activating clinical trials: a process improvement approach

    OpenAIRE

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

    2016-01-01

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

  6. Personalized Medicine: Genomics Trials in Oncology

    OpenAIRE

    Hayes, Daniel F.; Schott, Anne F

    2015-01-01

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

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

    Science.gov (United States)

    Scheltens, Philip; Twisk, Jos W R

    2013-01-01

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

  8. 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...

  9. Biomarkers in T cell therapy clinical trials

    OpenAIRE

    Kalos Michael

    2011-01-01

    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 pri...

  10. Balance algorithm for cluster randomized trials

    OpenAIRE

    Hood Kerenza; Carter Ben R

    2008-01-01

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

  11. 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...

  12. 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.

  13. Alternative methods to evaluate trial level surrogacy

    OpenAIRE

    Cortinas Abrahantes, Jose; SHKEDY, Ziv; Molenberghs, Geert

    2008-01-01

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

  14. 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

  15. Friendship Dynamics Between Emotions and Trials

    OpenAIRE

    Paola Rebughini

    2011-01-01

    The aim of this article is to analyze friendship ties and the emotions connected to them in some particular phases of life: periods when subjects are faced with difficult challenges such as mourning, separation, job loss or illness. Under these circumstances, friendship ties and emotions take on exceptional intensity. To investigate this moments I will use the analytical concept of trial and I will outline its heuristic utility in the analysis of friendship ties. The article is based on a res...

  16. Clinical Trials and their Impact on Society

    OpenAIRE

    Olga Lidia Cuevas Pérez; Ana María Molina Gómez; Diana Rosa Fernández Ruiz

    2016-01-01

    Today there are countless examples that illustrate the nature of technoscience, including biotechnology and pharmacology. The clinical trial is the appropriate methodology used by clinical pharmacology to test the efficacy and safety of a treatment or intervention in humans. It constitutes the cornerstone of research. Once the preclinical research is completed, one of the biggest challenges currently facing the Cuban Pharmaceutical and Biotechnological Industry is precisely the clinical evalu...

  17. Bacteriophage Therapy: Advances in Formulation Strategies and Human Clinical Trials.

    Science.gov (United States)

    Vandenheuvel, Dieter; Lavigne, Rob; Brüssow, Harald

    2015-11-01

    Recently, a number of phage therapy phase I and II safety trials have been concluded, showing no notable safety concerns associated with the use of phage. Though hurdles for efficient treatment remain, these trials hold promise for future phase III clinical trials. Interestingly, most phage formulations used in these clinical trials are straightforward phage suspensions, and not much research has focused on the processing of phage cocktails in specific pharmaceutical dosage forms. Additional research on formulation strategies and the stability of phage-based drugs will be of key importance, especially with phage therapy advancing toward phase III clinical trials. PMID:26958930

  18. The Colon Health and Life-Long Exercise Change trial: a randomized trial of the National Cancer Institute of Canada Clinical Trials Group

    OpenAIRE

    Courneya, K.S.; Booth, C. M.; S. Gill; P. O’brien; Vardy, J.; Friedenreich, C.M.; Au, H.J.; Brundage, M.D.; Tu, D; Dhillon, H.; Meyer, R. M.

    2008-01-01

    Background Observational studies indicate that physical activity (pa) is strongly associated with improved disease outcomes in colon cancer survivors, but a randomized controlled trial is needed to determine whether the association is causal and whether new policies to promote exercise are justified. Purpose The co.21 Colon Health and Life-Long Exercise Change (challenge) trial undertaken by the National Cancer Institute of Canada Clinical Trials Group (ncic ctg) is designed to determine the ...

  19. Neuroprotection Trials in Traumatic Brain Injury.

    Science.gov (United States)

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

    2016-04-01

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

  20. Gateways to clinical trials. December 2008.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2008-12-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables 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: AAV1/SERCA2a; Abatacept, ABT-263, Adalimumab, Aflibercept, Afobazole, Aliskiren fumarate, Anakinra, Atazanavir/ritonavir, Aviscumine, Axitinib, Azacitidine; Bevacizumab, Biphasic insulin aspart, Bortezomib, Briobacept; Carmoterol hydrochloride, CCX-282, Ceftobiprole medocaril, Certolizumab pegol, Cetuximab; Darifenacin hydrobromide, Dasatinib, Denosumab, Doripenem, Duloxetine hydrochloride; E-7080, Epratuzumab, Erlotinib hydrochloride, Everolimus, Exenatide, Ezetimibe/simvastatin; Gefitinib, Golimumab; gamma-Hydroxybutyrate sodium; Imatinib mesylate, Insulin detemir, Insulin glulisine, IVX-0142; Laquinimod sodium, Linezolid, Lopinavir/ritonavir; Ocrelizumab, Omalizumab; Parecoxib sodium, Pemetrexed disodium, Pregabalin; Rosuvastatin calcium, Rotigotine; Sorafenib, Sugammadex sodium; Tapentadol hydrochloride, Tenofovir disoproxil fumarate/emtricitabine, Tocilizumab; Ularitide, Ustekinumab; Valsartan/amlodipine besylate, Varenicline tartrate, Vatalanib succinate, Vildagliptin, Vorinostat. PMID:19271026

  1. European Nicotinamide Diabetes Intervention Trial (ENDIT)

    DEFF Research Database (Denmark)

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

    2004-01-01

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

  2. Privacy and confidentiality in pragmatic clinical trials.

    Science.gov (United States)

    McGraw, Deven; Greene, Sarah M; Miner, Caroline S; Staman, Karen L; Welch, Mary Jane; Rubel, Alan

    2015-10-01

    With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons—which encompasses their interests in health information privacy—can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations. PMID:26374682

  3. Protocol for the Femoroacetabular Impingement Trial (FAIT)

    Science.gov (United States)

    Palmer, A. J. R.; Ayyar-Gupta, V.; Dutton, S. J.; Rombach, I.; Cooper, C. D.; Pollard, T. C.; Hollinghurst, D.; Taylor, A.; Barker, K. L.; McNally, E. G.; Beard, D. J.; Andrade, A. J.; Carr, A. J.; Glyn-Jones, S.

    2014-01-01

    Aims Femoroacetabular Junction Impingement (FAI) describes abnormalities in the shape of the femoral head–neck junction, or abnormalities in the orientation of the acetabulum. In the short term, FAI can give rise to pain and disability, and in the long-term it significantly increases the risk of developing osteoarthritis. The Femoroacetabular Impingement Trial (FAIT) aims to determine whether operative or non-operative intervention is more effective at improving symptoms and preventing the development and progression of osteoarthritis. Methods FAIT is a multicentre superiority parallel two-arm randomised controlled trial comparing physiotherapy and activity modification with arthroscopic surgery for the treatment of symptomatic FAI. Patients aged 18 to 60 with clinical and radiological evidence of FAI are eligible. Principal exclusion criteria include previous surgery to the index hip, established osteoarthritis (Kellgren–Lawrence ≥ 2), hip dysplasia (centre-edge angle < 20°), and completion of a physiotherapy programme targeting FAI within the previous 12 months. Recruitment will take place over 24 months and 120 patients will be randomised in a 1:1 ratio and followed up for three years. The two primary outcome measures are change in hip outcome score eight months post-randomisation (approximately six-months post-intervention initiation) and change in radiographic minimum joint space width 38 months post-randomisation. ClinicalTrials.gov: NCT01893034. Cite this article: Bone Joint Res 2014;3:321–7. PMID:25431439

  4. Modernizing Eligibility Criteria for Molecularly Driven Trials.

    Science.gov (United States)

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

    2015-09-01

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

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

    OpenAIRE

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

    1997-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Lois Biener

    2015-12-01

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

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

    Science.gov (United States)

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

    2015-01-01

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

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

    DEFF Research Database (Denmark)

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

    2001-01-01

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

  9. 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.

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

    OpenAIRE

    Christa Pichler; Andrea Maria Signorini

    2011-01-01

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

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

    Science.gov (United States)

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

    2005-03-20

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

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

    Science.gov (United States)

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

    2014-01-01

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

  13. Trial-to-Trial Reoptimization of Motor Behavior Due to Changes in Task Demands Is Limited

    OpenAIRE

    de Xivry, Jean-Jacques Orban

    2013-01-01

    Each task requires a specific motor behavior that is tuned to task demands. For instance, writing requires a lot of accuracy while clapping does not. It is known that the brain adjusts the motor behavior to different task demands as predicted by optimal control theory. In this study, the mechanism of this reoptimization process is investigated by varying the accuracy demands of a reaching task. In this task, the width of the reaching target (0.5 or 8 cm) was varied either on a trial-to-trial ...

  14. A data grid for imaging-based clinical trials

    Science.gov (United States)

    Zhou, Zheng; Chao, Sander S.; Lee, Jasper; Liu, Brent; Documet, Jorge; Huang, H. K.

    2007-03-01

    Clinical trials play a crucial role in testing new drugs or devices in modern medicine. Medical imaging has also become an important tool in clinical trials because images provide a unique and fast diagnosis with visual observation and quantitative assessment. A typical imaging-based clinical trial consists of: 1) A well-defined rigorous clinical trial protocol, 2) a radiology core that has a quality control mechanism, a biostatistics component, and a server for storing and distributing data and analysis results; and 3) many field sites that generate and send image studies to the radiology core. As the number of clinical trials increases, it becomes a challenge for a radiology core servicing multiple trials to have a server robust enough to administrate and quickly distribute information to participating radiologists/clinicians worldwide. The Data Grid can satisfy the aforementioned requirements of imaging based clinical trials. In this paper, we present a Data Grid architecture for imaging-based clinical trials. A Data Grid prototype has been implemented in the Image Processing and Informatics (IPI) Laboratory at the University of Southern California to test and evaluate performance in storing trial images and analysis results for a clinical trial. The implementation methodology and evaluation protocol of the Data Grid are presented.

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

    Science.gov (United States)

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

    2011-09-01

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

  16. Phase I trials involving radiation therapy, quantifying the risks

    International Nuclear Information System (INIS)

    Over one third of cancer patients receive radiation therapy (RT) at some point. Our purpose was to quantify the risks to patients associated with enrolment onto RT-based phase I trials. All phase I and phase I/II clinical trials involving RT published in English between 2001 and 2010 were identified via a PubMed search. For pragmatic reasons, we focused on trials from 2001, 2005 and 2009. For each trial we calculated a 'toxicity ratio' equal to the number of grade 3/4/5 toxic events divided by the number of patients in the trial. Linear regression was used to determine which variables were associated with higher toxicity ratios. There were a total of 33 treatment-related deaths, and 1812 acute grade 3/4 toxicities among the 2994 subjects in 98 trials. The median toxicity ratio over 98 trials was 0.46 (95% confidence interval (CI) 0.34 to 0.58). Multivariate regression analysis showed that toxicity ratios were significantly higher in trials with chemotherapy (P=0.002) and in trials for cancers of the head-and-neck (P<0.001). The median toxicity ratio in chemotherapy trials was 0.60 (95% CI: 0.48 to 0.72) compared with trials without chemotherapy 0.08 (95% CI: 0.03 to 0.13). Although the risk of grade 5 toxicity is low, the risk of major toxicity is significant in phase I RT trials. These values are comparable to published risk estimates for phase I non-RT trials.

  17. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The Info Trial Group

    DEFF Research Database (Denmark)

    Kruse, A Y; Kjaergard, L L; Krogsgaard, K; Gluud, C; Mortensen, E L; Gottschau, A; Bjerg, A M

    2000-01-01

    attitude toward randomized clinical trials was assessed in a randomized, parallel group, evaluator-blinded trial among 415 outpatients. The patients were randomized to the following groups: control (no intervention), leaflet, brochure, or booklet. Knowledge was assessed by a 17-item multiple-choice...

  18. The Electronic Evidence in Trial Proceedings

    Directory of Open Access Journals (Sweden)

    Monica Pocora

    2015-05-01

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

  19. Feeding trials of green seaweed Ulva fasciata

    OpenAIRE

    Alam, J.M.; Qasim, R.

    1993-01-01

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

  20. How to Appraise a Clinical Trial Critically

    OpenAIRE

    Sutherland, Lloyd R

    1995-01-01

    Most clinicians wish to base their therapeutic decisions on scientific data but are often overwhelmed by the number of case reports, open series and other therapeutic trials published each year. It is essential to develop a personal screening plan that can alert the clinician to which reports deserve extra attention, as they may alter management, and to which reports can be ignored. The first step is to review the abstract. Decisions related to therapeutics should be based on ‘randomized’, ‘c...

  1. Bicycle weight and commuting time: randomised trial

    OpenAIRE

    Groves, J

    2010-01-01

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

  2. 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)

  3. 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)

  4. Uncovering the emotional aspects of working on a clinical trial: a qualitative study of the experiences and views of staff involved in a type 1 diabetes trial

    OpenAIRE

    Lawton, J.; Kirkham, J.; White, D.; Rankin, D; Cooper, C; Heller, S

    2015-01-01

    Background The perspectives and experiences of trial staff are increasingly being investigated as these can be used to improve recruitment, adherence to trial protocols and support given to future staff. We interviewed staff working on a type 1 diabetes trial in order to aid interpretation of trial findings, inform recommendations for the rollout of the treatments investigated and provide recommendations for the conduct of future trials. However, our interviews uncovered aspects of trial w...

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

    Directory of Open Access Journals (Sweden)

    Radulovi? Sinia S.

    2003-01-01

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

  6. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G; Hróbjartsson, Asbjørn

    2014-01-01

    provided for subjective outcome: (1) dependent on assessor judgment, (2) patient-reported outcome, or (3) private phenomena (ie, phenomena only assessable by the patient). Of the 200 clinical trial reports, 12 used the term "subjective" and/or "objective" about outcomes, but no clinical trial reports...... explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial, in......OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...

  7. 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 Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...... optimistic estimates of effect. We pooled the differences in effect size using inverse variance random-effects meta-analysis and used metaregression to identify potential reasons for variation. RESULTS: We included 24 trials in our review. The main meta-analysis included 16 trials (involving 2854 patients...

  8. 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...

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

    Science.gov (United States)

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

    2012-07-18

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

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

    Science.gov (United States)

    Oba, Koji

    2016-02-01

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

  11. 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 Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two......%). Heterogeneity was moderate (I(2) = 46%, p = 0.02) and unexplained by metaregression. INTERPRETATION: We provide empirical evidence for observer bias in randomized clinical trials with subjective measurement scale outcomes. A failure to blind assessors of outcomes in such trials results in a high risk of...

  12. 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...... concluded that positive trials are cited significantly more often than negative trials. The association was not explained by disease area or methodological quality....

  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

    be combined with careful analysis of withdrawal patterns across treatments. The negative binomial model is currently the best approach to statistical analysis of exacerbation rates, while analysis of time to exacerbation can supplement this approach. In the TORCH trial, exacerbation rates were higher...

  14. Randomised Controlled Trials in Education Research: A Case Study of an Individually Randomised Pragmatic Trial

    Science.gov (United States)

    Torgerson, Carole J.

    2009-01-01

    The randomised controlled trial (RCT) is an evaluative method used by social scientists in order to establish whether or not an intervention is effective. This contribution discusses the fundamental aspects of good RCT design. These are illustrated through the use of a recently completed RCT which evaluated an information and communication…

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

    Directory of Open Access Journals (Sweden)

    Burgess LJ

    2011-09-01

    Full Text Available LJ Burgess, NU SulzerTREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and Stellenbosch University, Parow, South AfricaObjectives: To retrospectively analyze feasibility questionnaires to evaluate the number of trials that resulted in patient enrolment and the mean time frame involved.Methods: This study was conducted by TREAD Research, a site-managed organization based in the Western Cape, South Africa, between January 2004 and December 2009. All feasibility questionnaires received by the site over this time period were analyzed. Descriptive statistics were used to analyze the data.Results: A total of 252 feasibility questionnaires were received; 207 were accepted and 45 rejected. An average of 26.8% of trials started out of those feasibilities that were accepted by the site. The average time frame from feasibility acceptance to patient enrolment was 12.9 months (range 2.733.5 months.Conclusion: Improving the trial feasibility process would markedly improve a trial sites ability to plan effectively and efficiently allocate appropriate resources.Keywords: resource allocation, business planning, clinical research organizations

  16. Controlled trial of azathioprine in chronic ulcerative colitis.

    OpenAIRE

    Kirk, A P; Lennard-Jones, J E

    1982-01-01

    A double-blind controlled trial of azathioprine in a dose of 2-2.5 mg/kg body weight over six months was conducted among 44 patients with active chronic ulcerative colitis. Three patients treated with placebo did not complete the trial because their disease became so severe that colectomy was performed. Among patients who completed the trial the mean dose of prednisolone necessary to control the disease decreased in those treated with azathioprine and those treated with placebo; the reduction...

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

    OpenAIRE

    Singh Sonal; Loke Yoon K

    2012-01-01

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

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

    OpenAIRE

    Dellson, Pia; Nilbert, Mef; Carlsson, Christina

    2016-01-01

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

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

    OpenAIRE

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

    2013-01-01

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

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

    OpenAIRE

    . .

    2006-01-01

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

  1. Interim analysis in long-term clinical trials

    OpenAIRE

    Es, Gerrit Anne

    1990-01-01

    textabstractThe purpose of this dissertation is to evaluate the usefulness of both stopping rules and estimation methods in long-term clinical trials with interim analyses. The ASPECT trial, a long-term clinical trial to assess the effect of anticoagulant therapy on mortality in patients after myocardial infarction which is currently conducted in the Netherlands, serves as a major example throughout this dissertation. In the final stage of the development of a new therapy usually a large-scal...

  2. An Internet-Based Cancer Clinical Trials Matching Resource

    OpenAIRE

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

    2005-01-01

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

  3. Application of remote sensing to agricultural field trials.

    OpenAIRE

    Clevers, J. G. P. W.

    1986-01-01

    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...

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

    OpenAIRE

    Felson, David T.; Glantz, Leonard

    2004-01-01

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

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

    OpenAIRE

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

    2013-01-01

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

  6. The Columbia Registry of Controlled Clinical Computer Trials.

    OpenAIRE

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

    1992-01-01

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

  7. 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...

  8. Phase I Clinical Trials in Patients ≥80

    OpenAIRE

    Gaddipati, Himabindu; Fu, Pingfu; Dowlati, Afshin

    2011-01-01

    Phase I clinical trials play a crucial role in development of therapeutics for cancer patients. During phase I clinical trials common toxicities are delineated, dose limiting toxicities (DLT) are determined and a dose for phase II studies is recommended. However, reviews of the phase I population indicate a younger group of participants with a median age of 50-55. No data exists on the performance of octogenarians on phase I trials. Concerns for enrollment of this patient population, relates ...

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

    OpenAIRE

    SHORTER, EDWARD

    2011-01-01

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

  10. Figures in clinical trial reports: current practice & scope for improvement

    OpenAIRE

    Travison Thomas G; Pocock Stuart J; Wruck Lisa M

    2007-01-01

    Abstract Background Most clinical trial publications include figures, but there is little guidance on what results should be displayed as figures and how. Purpose To evaluate the current use of figures in Trial reports, and to make constructive suggestions for future practice. Methods We surveyed all 77 reports of randomised controlled trials in five general medical journals during November 2006 to January 2007. The numbers and types of figures were determined, and then each Figure was assess...

  11. Minimal clinically important differences in pharmacological trials.

    Science.gov (United States)

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

    2014-02-01

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

  12. Citation Sentiment Analysis in Clinical Trial Papers.

    Science.gov (United States)

    Xu, Jun; Zhang, Yaoyun; Wu, Yonghui; Wang, Jingqi; Dong, Xiao; Xu, Hua

    2015-01-01

    In scientific writing, positive credits and negative criticisms can often be seen in the text mentioning the cited papers, providing useful information about whether a study can be reproduced or not. In this study, we focus on citation sentiment analysis, which aims to determine the sentiment polarity that the citation context carries towards the cited paper. A citation sentiment corpus was annotated first on clinical trial papers. The effectiveness of n-gram and sentiment lexicon features, and problem-specified structure features for citation sentiment analysis were then examined using the annotated corpus. The combined features from the word n-grams, the sentiment lexicons and the structure information achieved the highest Micro F-score of 0.860 and Macro-F score of 0.719, indicating that it is feasible to use machine learning methods for citation sentiment analysis in biomedical publications. A comprehensive comparison between citation sentiment analysis of clinical trial papers and other general domains were conducted, which additionally highlights the unique challenges within this domain. PMID:26958274

  13. Leucaena leucocephala trials in Uttar Pradesh (India)

    Energy Technology Data Exchange (ETDEWEB)

    Chaturvedi, A.N.

    1981-10-01

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

  14. Competency to stand trial among female inpatients.

    Science.gov (United States)

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

    2013-08-01

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

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

    Science.gov (United States)

    Jefferson, Tom

    2016-01-01

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

  16. Phase 0 clinical trial- an overview

    Directory of Open Access Journals (Sweden)

    Aanchal Satija

    2011-07-01

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

  17. Clinical trials in branch retinal vein occlusion

    Directory of Open Access Journals (Sweden)

    Tandava Krishnan Panakanti

    2016-01-01

    Full Text Available Branch retinal vein occlusion (BRVO is the second most common retinal vascular disorder. The management of macular edema has changed considerably over time. The laser is considered the gold standard treatment for over two decades. However, visual recovery with laser is usually slow and incomplete. The advent of intravitreal agents, specifically anti-vascular endothelial growth factors (VEGF have heralded a new era which promises rapid recovery of vision and quality of vision. Randomized clinical trials have reported optimal results with anti-VEGF agents (ranibizumab, bevacizumab, and aflibercept compared to laser therapy or steroids. However, nearly 50% of the patients require repeat intravitreal anti-VEGF therapy up to 4 years after initiating therapy to sustain the visual gains. The adverse events (systemic and ocular of these agents are minimal. Monotherapy with anti-VEGF agents have been found to provide better results than any combination with laser. This review article summarizes evidence from randomized controlled trials evaluating treatment options for the treatment of macular edema secondary to BRVO with a special focus on anti-VEGF therapy.

  18. 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

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

    Science.gov (United States)

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

    2007-01-01

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

  20. The Home-Based Older People's Exercise (HOPE trial: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Forster Anne

    2011-06-01

    Full Text Available Abstract Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE trial is a two arm, assessor blind pilot randomised controlled trial (RCT to assess the effectiveness of a 12 week exercise intervention (the HOPE programme designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT, measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL, EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D quality of life measure and the geriatric depression scale (GDS, measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS, record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881

  1. Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis

    OpenAIRE

    Legocki, Laurie J.; Meurer, William J; Frederiksen, Shirley; Lewis, Roger J; Durkalski, Valerie L.; Berry, Donald A.; Barsan, William G; Fetters, Michael D.

    2015-01-01

    Background In an adaptive clinical trial (ACT), key trial characteristics may be altered during the course of the trial according to predefined rules in response to information that accumulates within the trial itself. In addition to having distinguishing scientific features, adaptive trials also may involve ethical considerations that differ from more traditional randomized trials. Better understanding of clinical trial experts’ views about the ethical aspects of adaptive designs could assis...

  2. 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

  3. THE TESTOSTERONE TRIALS: THE DESIGN OF SEVEN COORDINATED TRIALS TO DETERMINE IF TESTOSTERONE TREATMENT BENEFITS ELDERLY MEN

    Science.gov (United States)

    Snyder, Peter J; Ellenberg, Susan S; Cunningham, Glenn R; Matsumoto, Alvin M; Bhasin, Shalender; Barrett-Connor, Elizabeth; Gill, Thomas M; Farrar, John T; Cella, David; Rosen, Raymond C; Resnick, Susan M; Swerdloff, Ronald S; Cauley, Jane A; Cifelli, Denise; Fluharty, Laura; Pahor, Marco; Ensrud, Kristine E; Lewis, Cora E; Molitch, Mark E; Crandall, Jill P; Wang, Christina; Budoff, Matthew J; Wenger, Nanette K; Mohler, Emile R; Bild, Diane E; Cook, Nakela L; Keaveny, Tony M; Kopperdahl, David L; Lee, David; Schwartz, Ann V; Storer, Thomas W; Ershler, William B; Roy, Cindy N; Raffel, Leslie J; Romashkan, Sergei; Hadley, Evan

    2014-01-01

    Background The prevalence of low testosterone levels in men increases with age, as does the prevalence of decreased mobility, sexual function, self-perceived vitality, cognitive abilities, bone mineral density, and glucose tolerance, and of increased anemia and coronary artery disease. Similar changes occur in men who have low serum testosterone concentrations due to known pituitary or testicular disease, and testosterone treatment improves the abnormalities. Prior studies of the effect of testosterone treatment in elderly men, however, have produced equivocal results. Purpose To describe a coordinated set of clinical trials designed to avoid the pitfalls of prior studies and determine definitively if testosterone treatment of elderly men with low testosterone is efficacious in improving symptoms and objective measures of age-associated conditions. Methods We present the scientific and clinical rationale for the decisions made in the design of this trial. Results We designed The Testosterone Trials as a coordinated set of seven trials to determine if testosterone treatment of elderly men with low serum testosterone concentrations and also symptoms and objective evidence of impaired mobility and/or diminished libido and/or reduced vitality would be efficacious in improving mobility (Physical Function Trial), sexual function (Sexual Function Trial), fatigue (Vitality Trial), cognitive function (Cognitive Function Trial), hemoglobin (Anemia Trial), bone density (Bone Trial), and coronary artery plaque volume (Cardiovascular Trial). The scientific advantages of this coordination were common eligibility criteria, treatment and monitoring and the ability to pool safety data. The logistical advantages were a single steering committee, data coordinating center and data safety monitoring board (DSMB), the same clinical trial sites, and the possibility of men participating in multiple trials. The major consideration in subject selection was setting the eligibility criterion for serum testosterone low enough to ensure that the men were unequivocally testosterone deficient, but not so low as to preclude sufficient enrollment or eventual generalizability of the results. The major considerations in choosing primary end points for each trial were identifying those of the highest clinical importance and identifying the minimum clinically important differences between treatment arms for sample size estimation. Potential Limitations Setting the serum testosterone concentration sufficiently low to ensure that most men would be unequivocally testosterone deficient, as well as many other entry criteria, resulted in screening approximately 30 men in person to randomize one subject. Conclusions The Testosterone Trials were designed to determine definitively if testosterone treatment of elderly men with low testosterone would have any clinical benefit. Designing The Testosterone Trials as a coordinated set of seven trials afforded many important scientific and logistical advantages but required an intensive recruitment and screening effort. PMID:24686158

  4. Statistical considerations for a trial of Ebola virus disease therapeutics.

    Science.gov (United States)

    Proschan, Michael A; Dodd, Lori E; Price, Dionne

    2016-02-01

    The 2014 West African outbreak of Ebola virus ravaged Liberia, Sierra Leone, and Guinea, causing hemorrhagic fever and death. The need to identify effective therapeutics was acute. The usual drug development paradigm of phase I, followed by phase II, and then phase III trials would take too long. These and other factors led to the design of a clinical trial of Ebola virus disease therapeutics that differs from more conventional clinical trial designs. This article describes the Ebola virus disease medical countermeasures trial design and the thinking behind it. PMID:26768567

  5. The challenge of comorbidity in clinical trials for multiple sclerosis

    Science.gov (United States)

    Miller, Aaron; Sormani, Maria Pia; Thompson, Alan; Waubant, Emmanuelle; Trojano, Maria; O'Connor, Paul; Reingold, Stephen; Cohen, Jeffrey A.

    2016-01-01

    Objective: We aimed to provide recommendations for addressing comorbidity in clinical trial design and conduct in multiple sclerosis (MS). Methods: We held an international workshop, informed by a systematic review of the incidence and prevalence of comorbidity in MS and an international survey about research priorities for studying comorbidity including their relation to clinical trials in MS. Results: We recommend establishing age- and sex-specific incidence estimates for comorbidities in the MS population, including those that commonly raise concern in clinical trials of immunomodulatory agents; shifting phase III clinical trials of new therapies from explanatory to more pragmatic trials; describing comorbidity status of the enrolled population in publications reporting clinical trials; evaluating treatment response, tolerability, and safety in clinical trials according to comorbidity status; and considering comorbidity status in the design of pharmacovigilance strategies. Conclusion: Our recommendations will help address knowledge gaps regarding comorbidity that interfere with the ability to interpret safety in monitored trials and will enhance the generalizability of findings from clinical trials to “real world” settings where the MS population commonly has comorbid conditions. PMID:26888986

  6. A review of prospective Clinical Trials for neurogenic bladder: Pharmaceuticals

    Science.gov (United States)

    Braschi, Emmanuel; Lavelle, John

    2014-01-01

    Introduction The neurogenic urinary bladder is defined as a dysfunctional bladder associated with a known neurological injury. We review the data from good quality clinical trials looking at drug therapy for the neurogenic bladder. Materials and methods In order to identify as many prospective trials as possible, we performed Internet searches, using the same search string: Urinary Bladder, neurogenic (MESH). In each case, the search was limited to clinical trial, prospective trial, subjects were human and the language was English. There was no year limit for our search. The next step was duplicate removal, which led to a final number of 580 papers. We defined clear inclusion criteria for the papers. Results A total of 82 full text papers were reviewed and analyzed according to the previously mentioned algorithm. The oldest two prospective clinical trials date back to 1976, with an obvious increase in number of trials each year, reaching more than five trials per year after 2001, which demonstrates increased interest toward the subject. The total number of patients included in the trials is 3904, 888 of which are children. The male: female ratio is close to 1, although there were 9 studies where no information regarding the sex of the patients was available. Conclusions Our analysis stresses the acute need for good quality trials looking at the drugs used for the management of the patients with neurogenic bladders, with adequate statistical power to support the data they present. PMID:25247085

  7. Recruitment and Retention of Patients into Emergency Medicine Clinical Trials

    Science.gov (United States)

    Cofield, Stacey; Conwit, Robin; Barsan, William; Quinn, James

    2010-01-01

    The emergency medicine and pre-hospital environments are unlike any other clinical environments and require special consideration to allow the successful implementation of clinical trials. This article reviews the specific issues involved in Emergency Medicine Clinical Trials (EMCT), and provides strategies from emergency medicine and non-emergency medicine trials to maximize recruitment and retention. While the evidence supporting some of these strategies is deficient, addressing recruitment and retention issues with specific strategies will help researchers deal with these issues in their funding applications and in turn develop the necessary infrastructure to participate in emergency medicine clinical trials. PMID:21040112

  8. Phase I (first-in-man prophylactic vaccine?s clinical trials: Selecting a clinical trial site

    Directory of Open Access Journals (Sweden)

    Shantanu Mehta

    2015-01-01

    Full Text Available An appropriately equipped and staffed Phase I unit is critical for smooth conduct of a first-in-man clinical trial. The first-in-man prophylactic vaccine trial(s requires basic infrastructure of clinical trial site, experienced and dedicated site staff and healthy adults as volunteers. The facility should have access to equipment, emergency services, laboratory, pharmacy and archiving.In terms of design, infrastructure, workflow and manpower, a Phase I unit for testing a novel vaccine or drug are quite similar. However, there are some important attributes, which should be taken into consideration, while performing pre-trial site selection for conducting phase I trial with a new or novel vaccine.

  9. 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.

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

    Directory of Open Access Journals (Sweden)

    Molyneux Andrew J

    2011-03-01

    Full Text Available Abstract The trial on endovascular management of unruptured intracranial aneurysms (TEAM, a prospective randomized trial comparing coiling and conservative management, initiated in September 2006, was stopped in June 2009 because of poor recruitment (80 patients. Aspects of the trial design that may have contributed to this failure are reviewed in the hope of identifying better ways to successfully complete this special type of pragmatic trial which seeks to test two strategies that are in routine clinical use. Cultural, conceptual and bureaucratic hurdles and difficulties obstruct all trials. These obstacles are however particularly misplaced when the trial aims to identify what a good medical practice should be. A clean separation between research and practice, with diverging ethical and scientific requirements, has been enforced for decades, but it cannot work when care needs to be provided in the presence of pervasive uncertainty. Hence valid and robust scientific methods need to be legitimately re-integrated into clinical practice when reliable knowledge is in want. A special status should be reserved for what we would call 'clinical care trials', if we are to practice in a transparent and prospective fashion a medicine that leads to demonstrably better patient outcomes.

  11. Randomised trials of STD treatment for HIV prevention: report of an international workshop. HIV/STD Trials Workshop Group.

    OpenAIRE

    Hayes, R.; Wawer, M; Gray, R.; Whitworth, J.; Grosskurth, H; MABEY, D.

    1997-01-01

    Three community trials of the impact of STD treatment interventions on HIV incidence in rural populations have been completed or are in progress in Uganda and Tanzania. Investigators from these trials met for a joint technical workshop in Baltimore in May 1996. This report summarises the consensus of the workshop, with the aim of providing useful input to research on HIV intervention strategies. Issues discussed include: (i) the role of community randomised trials; (ii) strategies for STD man...

  12. 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...

  13. 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...

  14. 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...

  15. Can we improve the statistical analysis of stroke trials? Statistical re-analysis of functional outcomes in stroke trials

    OpenAIRE

    Bath, Philip

    2007-01-01

    Background Most large acute stroke trials have been neutral. Functional outcome is usually analysed using a yes or no answer, e.g. death or dependency vs. independence. We assessed which statistical approaches are most efficient in analysing outcomes from stroke trials. Methods Individual patient data from acute, rehabilitation and stroke unit trials studying the effects of interventions which alter functional outcome were assessed. Outcomes included modified Rankin Scale, Bar...

  16. Improving the quality of randomized controlled trials in Chinese herbal medicine, Part ?: clinical trial design and methodology

    Directory of Open Access Journals (Sweden)

    Zhao-Xiang BIAN

    2006-03-01

    Full Text Available Objective: To discuss the quality of randomized controlled trials (RCTs in Chinese herbal medicine (CHM with respect to design and methodology, and provide suggestions for further improvement in future clinical trials. Methods: A search of the Cochrane Library was conducted to identify RCTs of CHM on line in July 2005. Quality of the RCTs was assessed using a 11-item checklist modified from the revised CONSORT statement, with 2 items specific to CHM (i.e. herb preparation form and quality control of herbs. Results: The search yielded 167 RCTs that were selected for assessment. All trials included statements about the interventions, objectives, primary outcome design, statistical methods, and herb preparation form. Although 163 (97.6% trials reported inclusion criteria, exclusion criteria were only reported in 26 (15.6% trials. Fewer than 10% of trials clearly stated the random allocation sequence generation methods, and only 2.4% mentioned allocation concealment. The vast majority (86.8% of trials were open-label, while only 13.2% used blinding. Almost half (45.5% administered the CHM intervention as a tea or decoction. Only one trial (0.6% reported a sample size calculation, and a single trial (0.6% discussed quality control of the CHM intervention. Conclusion: The overall methodologic quality of RCTs in CHM was poor. It is essential to improve the design of future RCTs in this clinical area. Recommendations: (1 Investigator conducting RCTs should have formal training about clinical trial design; (2 A flow chart is recommended to ensure that all essential steps of clinical trial design are included. (3 Conducting pilot studies prior to RCTs may help improve their design; (4 Registration of clinical trials and publishing their protocols prior to enrolment may reduce publication bias and solicit peer reviews of the proposed design; (5 Collaboration between CHM investigators and traditional medicine academic research centers interested in integrative medicine may lead to quality improvement of RCTs of CHM.

  17. Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

    OpenAIRE

    Mullan Rebecca J; Bankhead Clare R; Kaur Jagdeep; Sood Amit; Raatz Heike; Mulla Sohail M; Burns Karen EA; Nordmann Alain J; Lampropulos Julianna F; Bucher Heiner C; Karanicolas Paul J; You John J; Elnour Nisrin; Soares Heloisa P; Kirpalani Haresh

    2009-01-01

    Abstract Background Randomized clinical trials (RCTs) stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs) may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1), which systematically reviewed the epidemiol...

  18. Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

    OpenAIRE

    Rahu Mati; Veerus Piret; Hovi Sirpa-Liisa; Hemminki Elina

    2008-01-01

    Abstract Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT), originally planned to continue for five years, was planned in co-operation with t...

  19. Individual nutrition therapy and exercise regime: A controlled trial of injured, vulnerable elderly (INTERACTIVE trial

    Directory of Open Access Journals (Sweden)

    Whitehead Craig

    2008-02-01

    Full Text Available Abstract Background Proximal femoral fractures are amongst the most devastating consequences of osteoporosis and injurious accidental falls with 25–35% of patients dying in the first year post-fracture. Effective rehabilitation strategies are evolving however, despite established associations between nutrition, mobility, strength and strength-related functional outcomes; there has been only one small study with older adults immediately following fragility fracture where a combination of both exercise and nutrition have been provided. The aim of the INTERACTIVE trial is to establish whether a six month, individualised exercise and nutrition program commencing within fourteen days of surgery for proximal femur fracture, results in clinically and statistically significant improvements in physical function, body composition and quality of life at an acceptable level of cost and resource use and without increasing the burden of caregivers. Methods and Design This randomised controlled trial will be performed across two sites, a 500 bed acute hospital in Adelaide, South Australia and a 250 bed acute hospital in Sydney, New South Wales. Four hundred and sixty community-dwelling older adults aged > 70 will be recruited after suffering a proximal femoral fracture and followed into the community over a 12-month period. Participants allocated to the intervention group will receive a six month individualised care plan combining resistance training and nutrition therapy commencing within 14 days post-surgery. Outcomes will be assessed by an individual masked to treatment allocation at six and 12 months. To determine differences between the groups at the primary end-point (six months, ANCOVA or logistic regression will be used with models adjusted according to potential confounders. Discussion The INTERACTIVE trial is among the first to combine nutrition and exercise therapy as an early intervention to address the serious consequence of rapid deconditioning and weight loss and subsequent ability to regain pre-morbid function in older patients post proximal femoral fracture. The results of this trial will guide the development of more effective rehabilitation programs, which may ultimately lead to reduced health care costs, and improvements in mobility, independence and quality of life for proximal femoral fracture sufferers. Trial registration Australian Clinical Trials Registry: ACTRN12607000017426.

  20. 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.