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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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, p...

Urb, Liina

2011-01-01

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

Directory of Open Access Journals (Sweden)

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.

Mohammad Javad Ghasemi

2014-03-01

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The Distances and Absolute Magnitudes of Some Well-Known Red Variables  

Science.gov (United States)

Distances and absolute magnitudes have been obtained from an early distribution of Hipparcos data for a number of well-known late-type variables. These data were requested in 1981 in order to ensure that these important stars were not excluded from the Input Catalogue on account of their variability or very red color. Measurements were requested for 20 Mira variables, and 14 of these were successfully observed. Of these, the nearest to the Sun were found to be R Leo (at 102 pc), chi Cyg (106), R Cas (107), R Car (128), T Cep (210), and R Aql (211), with formal errors ranging from plus or minus 12 to plus or minus 57 pc. The absolute visual magnitudes of Miras at mean maximum range approximately from --2.5 to +2.0 with a clear dependence on spectral type (cooler stars being fainter). This trend is reversed for absolute magnitudes in the near infrared. Results are also given for 10 small-amplitude variables of late type. The nearest of these are L_2 Pup (M5 III, 61 pc) and R Dor (M8e, 62 pc). The symbiotic star CH Cyg lies at a rather uncertain distance of 268 plus or minus 65 pc. Data were obtained for 23 carbon stars, including the brightest representatives of each of several subgroups. The nearest of these was found to be the SRb variable U Hya, at 162 plus or minus 20 pc. The stars 19 Psc, Y CVn, W Ori, and HD 201626 were all found to be somewhat more than 200 pc from the Sun.

Wing, R. F.

4

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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...

Phan Ngoc, Tam

2011-01-01

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Vitamin-induced intracellular electrons are the mechanism for their well-known beneficial effects: a review.  

Science.gov (United States)

A new conception of the action mechanisms of vitamins and some other compounds without a vitamin status is briefly presented. It is based on results obtained through pulse radiolysis, molecular radiation biological investigations, and in vitro studies. The data clearly show that antioxidant vitamins (C, E, ?-carotene) and B vitamins and related compounds possess the capability to emit "solvated electrons" in aqueous solutions or polar media. In consequence, the well-known vitamin effects are attributed to the action of the emitted solvated electrons and the resulting vitamin free radicals rather than the vitamin molecules per se, as generally accepted. PMID:23306138

Getoff, Nikola

2013-04-01

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

Directory of Open Access Journals (Sweden)

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

Pralhad S. Patki

2013-02-01

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Implications of Two Well-Known Models for Instructional Designers in Distance Education: Dick-Carey versus Morrison-Ross-Kemp  

Science.gov (United States)

This paper first summarizes, and then compares and contrasts two well-known instructional design models: Dick and Carey Model (DC) and Morrison, Ross and Kemp model (MRK). The target audiences of both models are basically instructional designers. Both models have applications for different instructional design settings. They both see the…

Akbulut, Yavuz

2007-01-01

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[Well-known Swiss physician Albrecht von Haller and his contribution to the development of modern physiology as a separate discipline].  

Science.gov (United States)

The article presents data about well-known Swiss physician, the anatomist, the physiologist, embryologist, the scientist and poet Albrecht FON HALLER. His role in the development of modern physiology as the separate discipline based on physiological experiment is considered. PMID:19663025

Pavlovski?, L N

2008-01-01

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

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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 Norweg...

2007-01-01

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A method of determining the response function of neutron detectors by irradiating them in neutron fields with well-known spectra  

International Nuclear Information System (INIS)

A general approach is presented to solve the problem which is based on the formulation of the inverse problem, i.e. unfolding of the response function R(E) using the results of measurements of the detector response in well-known neutron fields. For the example of the detector used in personnel dosimetry the neutron spectra are selected, a mathematical model of the R(E) unfolding process is given, and measurements in real neutron fields are carried out. The R(E) unfolding results are given for an albedo and a film dosimeter. (author)

1988-06-01

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Implications of Two Well-Known Models For Instructional Designers In Distance Education:Dick-Carey Versus Morrison-Ross-Kemp  

Directory of Open Access Journals (Sweden)

Full Text Available This paper first summarizes, and then compares and contrasts two well-known instructional design models: Dick and Carey Model (DC and Morrison, Ross and Kemp model (MRK. The target audiences of both models are basically instructional designers. Both models have applications for different instructional design settings. They both see the instructional design as a means to problem-solving. However, there are also differences between the two models. Applications of each model for instructional design and technology are discussed, and a reference to instructional designers in distance education was made.

Yavuz AKBULUT

2007-04-01

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A comparison of computational data, obtained with a variety of well-known radiation transport codes (MCNP, ANISN, FLUKA, ROZ6H)  

International Nuclear Information System (INIS)

A verification of the calculational data obtained with different well-known radiation transport codes and nuclear cross section sets (MCNP+ENDF/B, ANISN+HILO, FLUKA92) has been made by comparison with the results of precision ROZ6H+SADCO calculations and available experimental data. The results obtained with the MCNP+ENDF/B-5 package and ROZ6H+SADCO-computed data for neutron penetration in iron at energies E?14 MeV are in good agreement. For the calculations using ANISN at energies ?400 MeV and FLUKA at energies ?200 GeV, there are significant discrepancies both from the ROZ6H calculations and experimental data. The differences are discussed. (orig.)

1996-05-11

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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)

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.

Naess Eva E

2007-02-01

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

Science.gov (United States)

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.

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

2007-01-01

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

Science.gov (United States)

A simple and sensitive high-performance liquid chromatography coupled with diode array detection (HPLC-DAD) method was investigated for simultaneous determination of 11 components (chlorogenic acid, coptisine, epiberberine, jatrorrhizine, berberine, palmatine, baicalin, wogonoside, baicalein, wogonin and chrysin) in Qinhuanghouzheng (QHHZ) capsule and Xiaoerqingre (XEQR) tablet, for quality control of these two well-known traditional Chinese medicines (TCMs). The method was established using an Eclipse Plus C(18) (150 mm x 4.6 mm i.d., 5 microm) column. The mobile phase comprising methanol (A) 3% phosphoric acid (B) (pH 2.0, adjusted by triethylamine) was used to elute the targets in gradient elution mode. Flow rate and detection wavelength were set at 0.8 mL/min and 270 nm, respectively. All calibration curves showed good linearity with R(2) > 0.9995. Inter- and intra-day precisions for all investigated components expressed as relative standard deviation (R.S.D.) ranged from 0.26% to 1.77%. Recoveries measured at three concentrations were in the range of 95.0-103.0% with R.S.D. < or = 3%. The validated method is simple, reliable, and successfully applied to determine the contents of the selected compounds in QHHZ capsule and XEQR tablet for quality evaluation and control. The 11 main active marker compounds measured occur only in 2 or 3 plant species out of 7-10 species comprising the two TCMs. Additional procedures need to be developed for the quality control of plant materials other than Coptis chinensis Franch, Scutellaria baicalensis Georgi and Phellodendron amurense Rupr. PMID:19264437

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

2009-05-01

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

Scientific Electronic Library Online (English)

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

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

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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)

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.

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

2010-05-15

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Matter collineations of some well-known spacetimes  

International Nuclear Information System (INIS)

Matter collineations of the Bianchi types-I, -II, -III, -VIII and -IX, and Kantowski-Sachs spacetimes are derived in this paper. It is found that matter collineations turn out similar to Ricci collineations with different constraint equations. It is solved the constraint equation for a particular case and obtain three cosmological models which represent perfect-fluid dust solutions

2001-06-01

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Solar p--p reaction: a well known process  

International Nuclear Information System (INIS)

It is emphasized that the pp reaction should be able to be calculated to a similar precision as the corresponding radiative neutron--proton capture, having an uncertainty of one to two percent. Also recent calculations of heavy meson exchanges in the treatment of meson-exchange currents are noted. 10 references

1978-01-07

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Using well-known techniques for classifying user behavior profiles  

Digital Repository Infrastructure Vision for European Research (DRIVER)

The security of a computer is based on the realization of confidentiality, integrity, and availability. A computer can keep track of computer users to improve the security in the system. However, this does not prevent a user from impersonating another user. If a computer system can model the behavior of the users, it can be very beneficial detecting masqueraders, assisting them or predicting their future actions. In this paper, we present three different methods for classifying the behavior o...

Iglesias, Jose? Antonio; Ledezma, Agapito; Sanchis, Araceli

2008-01-01

 
 
 
 
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Clinical Trials  

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Full Text Available ... well it may or may not work. Why are Clinical Trials Important? Researchers use clinical trials to ... a research effort that may help others. How are Clinical Trials Conducted? Every clinical trial is designed ...

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

DEFF Research Database (Denmark)

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).

Jemec, Gregor; Ullman, Susanne

2009-01-01

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Clinical Trials  

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Full Text Available ... how well it may or may not work. Why are Clinical Trials Important? Researchers use clinical trials ... com hc010104 Last reviewed: 09/15/2012 1 Why Should You Be Interested in a Clinical Trial? ...

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Clinical Trials  

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Full Text Available ... and help answer some of the most common questions. What is a Clinical Trial? A clinical trial ... is designed to answer a set of research questions. The doctors who conduct a clinical trial follow ...

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Clinical Trials  

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Full Text Available ... ongoing basis. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' ...

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Clinical Trials  

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Full Text Available ... 15/2012 1 Why Should You Be Interested in a Clinical Trial? People volunteer to take part ... What Protection Do You Have As A Participant In A Clinical Trial? The ethical and legal codes ...

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Clinical Trials  

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Full Text Available ... Do You Have As A Participant In A Clinical Trial? The ethical and legal codes that govern medical practice apply to clinical trials. In addition, most clinical research is federally ...

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Clinical Trials  

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Full Text Available ... and effective. During a trial, more and more information is gained about a new treatment, its risks, ... trial, you will continue to receive any new information about the study that may affect your willingness ...

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Clinical Trials  

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Full Text Available ... laboratory. The treatments with the most promising laboratory results are moved into clinical trials. Clinical trials help ... treatment will be disappointing. However, based on laboratory results, the researchers have reason to believe that the ...

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Clinical Trials  

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Full Text Available ... trial is a research study done to evaluate new treatments in people. Carefully conducted clinical trials are the fastest way to find new treatments that work in people. You may be ...

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Trial-by-trial fluctuations in the event-related electroencephalogram reflect dynamic changes in the degree of surprise.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

The P300 component of the human event-related brain potential has often been linked to the processing of rare, surprising events. However, the formal computational processes underlying the generation of the P300 are not well known. Here, we formulate a simple model of trial-by-trial learning of stimulus probabilities based on Information Theory. Specifically, we modeled the surprise associated with the occurrence of a visual stimulus to provide a formal quantification of the "subjective proba...

Mars, Rb; Debener, S.; Gladwin, Te; Harrison, Lm; Haggard, P.; Rothwell, JC; Bestmann, S.

2008-01-01

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Classical EIS and square pattern signals comparison based on a well-known reference impedance  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Electrochemical impedance spectroscopy or ac impeda nce methods are popularly used for the diagnosis of electrochemical generators (batteries or fuel cell) . It is now possible to acquire and quantitatively interpret the experimental electrical impedances of such syst ems, whose evolutions indirectly reflect the modifications of the internal electrochemical proce ss. The scope of these measurement methods is to identify the frequency response function of the sys tem under test by applying a s...

Al-nazer, Rouba; Cattin, Viviane; Granjon, Pierre; Montaru, Maxime; Ranieri, Marco; Heiries, Vincent

2013-01-01

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The well-known unknown photographer Jaan Klõšeiko / Ellu Maar  

Index Scriptorium Estoniae

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

Maar, Ellu, 1982-

2010-01-01

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

Science.gov (United States)

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

Miele, C; Beguinot, F

2012-05-01

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A bound for the smoothing parameter in certain well-known nonparametric density estimators  

Science.gov (United States)

Two classes of nonparametric density estimators, the histogram and the kernel estimator, both require a choice of smoothing parameter, or 'window width'. The optimum choice of this parameter is in general very difficult. An upper bound to the choices that depends only on the standard deviation of the distribution is described.

Terrell, G. R.

1980-01-01

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

Directory of Open Access Journals (Sweden)

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.

Mohmood Mohammadian

2012-08-01

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Pimafucort®. New approach to well-known drug Pimafucort®. Nowe spojrzenie na dobrze znany lek  

Directory of Open Access Journals (Sweden)

Full Text Available Pimafucort, which is composed of natamycin, neomycin and hydrocortisone is a valuable drug used in mixed infections caused by bacteria and fungi as well as in the onset of acute inflammation in different dermatoses (e.g. eczema or intertrigo with secondary contamination.

Wojciech Baran

2011-09-01

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Recurrent hypoglycemia…: A less well-known presentation of Sheehan's syndrome.  

Science.gov (United States)

Sheehan's syndrome is a rare cause of recurrent hypoglycemia. We present a case of a middle aged woman who presented with recurrent life threatening hypoglycemia. Based on a past history of severe post partum hemmorhage and a clinical picture of myxedema and secondary amennorhea, laboratory and neuroimaging was undertaken to confirm a diagnosis of Sheehan's syndrome. The patient responded to treatment with thyroxine and steroids in replacement doses. The case report emphasises the importance of early suspicion and management of this easily missed and treatable condition. PMID:24346393

Dosi, R V; Bhatt, N R; Patell, R D; Raj, R R

2013-01-01

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Nitric Oxide: Perspectives and Emerging Studies of a Well Known Cytotoxin  

Directory of Open Access Journals (Sweden)

Full Text Available The free radical nitric oxide (NO? is known to play a dual role in human physiology and pathophysiology. At low levels, NO? can protect cells; however, at higher levels, NO? is a known cytotoxin, having been implicated in tumor angiogenesis and progression. While the majority of research devoted to understanding the role of NO? in cancer has to date been tissue-specific, we herein review underlying commonalities of NO? which may well exist among tumors arising from a variety of different sites. We also discuss the role of NO? in human physiology and pathophysiology, including the very important relationship between NO? and the glutathione-transferases, a class of protective enzymes involved in cellular protection. The emerging role of NO? in three main areas of epigenetics—DNA methylation, microRNAs, and histone modifications—is then discussed. Finally, we describe the recent development of a model cell line system in which human tumor cell lines were adapted to high NO? (HNO levels. We anticipate that these HNO cell lines will serve as a useful tool in the ongoing efforts to better understand the role of NO? in cancer.

James A. Radosevich

2010-07-01

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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 c...

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

2010-01-01

 
 
 
 
41

Numerical evaluation of the intensity transport equation for well-known wavefronts and intensity distributions  

Science.gov (United States)

In order to obtain a clearer interpretation of the Intensity Transport Equation (ITE), in this work, we propose an algorithm to solve it for some particular wavefronts and its corresponding intensity distributions. By simulating intensity distributions in some planes, the ITE is turns into a Poisson equation with Neumann boundary conditions. The Poisson equation is solved by means of the iterative algorithm SOR (Simultaneous Over-Relaxation).

Campos-García, Manuel; Granados-Agustín, Fermín.; Cornejo-Rodríguez, Alejandro; Estrada-Molina, Amilcar; Avendaño-Alejo, Maximino; Moreno-Oliva, Víctor Iván.

2013-11-01

42

Clinical Trials  

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Full Text Available ... to take part in clinical trials for many reasons. First is the hope that by participating in ... However, based on laboratory results, the researchers have reason to believe that the new treatment will be ...

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Clinical Trials  

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Full Text Available ... Informed Consent Informed consent is a process of learning key facts about a clinical trial before deciding ... for your specific condition. ©1995-2012, The Patient Education Institute, Inc. www.X-Plain.com hc010104 Last ...

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Clinical Trials  

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Full Text Available ... a group receives is often decided by a process called “randomization.” It's like tossing a coin, only ... and benefits. Informed Consent Informed consent is a process of learning key facts about a clinical trial ...

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Clinical Trials  

Medline Plus

Full Text Available ... team. What Protection Do You Have As A Participant In A Clinical Trial? The ethical and legal ... federally regulated with built-in safeguards to protect participants. This document is for informational purposes and is ...

46

Clinical Trials  

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Full Text Available ... treatments in people. Each study is designed to learn about a potential treatment and its effects on ... Informed Consent Informed consent is a process of learning key facts about a clinical trial before deciding ...

47

Participating in Clinical Trials  

Medline Plus

Full Text Available ... 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 of a clinical trial is ...

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Learn about Clinical Trials  

Science.gov (United States)

Learn About Clinical Trials In English En español Updated: 07/01/2013 Learn About Clinical Trials What ... Dictionary Search for Clinical Trials NCI Publications Español Learn About Clinical Trials Help Yourself, Help Others You ...

49

Participating in Clinical Trials  

Medline Plus

Full Text Available ... such as surgical techniques, psychiatric therapy, or radiotherapy. Click for more information Scientists usually do years of ... can join this type of trial. Prevention Trials Click for more information In prevention trials, researchers study ...

50

Current Clinical Trials  

Science.gov (United States)

Current Clinical Trials Related Pages Breast Cancer Home PageNCI's gateway for information about breast cancer. Early Detection and Prevention Trials for Breast CancerFrom NCI's clinical trials database. Breast Cancer Home PageNCI's gateway for information

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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 ...

52

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

Directory of Open Access Journals (Sweden)

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

Azize Hassan

2011-12-01

53

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

Science.gov (United States)

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

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

2003-01-01

54

Pharmacognostical study and establishment of quality parameters of aerial parts of Costus speciosus-a well known tropical folklore medicine  

Science.gov (United States)

Objective To evaluate the diagnostic pharmacognostical characters of Costus speciosus (aerial parts) along with their physico-chemical parameters and fluorosence analysis. Method The pharmacognostical characters were determined in terms of macroscopy, microscopy, powder microscopy, leaf constant, fluorescence analysis and preliminary phytochemical investigation. Results The findings of macroscopy revealed that leaves elliptic to oblong or oblong-lancoelate, thick, spirally arranged, with stem clasping sheaths up to 4 cm, flowers large, white, cone-like terminal spikes, with bright red bracts. Transverse section of leaflet showed the presence of cuticularised epidermis with polygonal cells on adaxial surface and bluntly angled cells on abaxial surface of lamina, mesophyll cells differentiated in to single layered palisade cells on each surface and 2-3 layered spongy parenchyma, unicellular and uniseriate multicellular covering trichomes, paracytic stomata and vascular bundles surrounded by sclerenchymatous multicellular sheath. Preliminary phytochemical screening exhibited the presence of various phytochemical groups like alkaloids, glycosides, steroids, phenolic constituents. Further, the leaf constants, powder microscopy and fluorescence characteristics indicated outstanding results from this investigation Conclusions Various pharmacognostical and physico-chemical parameters have pivotal roles in identification, authentication and establishment of quality parameters of the species.

Singh, Pradeep; Khosa, Ratan Lal; Srivastava, Shruti; Mishra, Garima; Jha, Keshri Kishor; Srivastava, Sourabh; Sangeeta; Verma, Ramesh Kumar; Tahseen, Mohd Adil

2014-01-01

55

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.

2010-07-01

56

Enhancing Hormonal Therapy for Breast Cancer by Combination with a Well- Known Approved Pharmaceutical with Little Toxicity.  

Science.gov (United States)

The beneficial effects of hormonal therapy with antiestrogens or aromatase inhibitors for estrogen receptor (ER) positive metastatic breast cancer are limited by the phenomenon of hormonal resistance. We have found that valproic acid (VPA), a pharmaceutic...

P. Kushner

2008-01-01

57

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

Science.gov (United States)

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

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

2013-11-01

58

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

Energy Technology Data Exchange (ETDEWEB)

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.

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

59

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

Energy Technology Data Exchange (ETDEWEB)

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)

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

60

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

2003-01-01

 
 
 
 
61

Participating in Clinical Trials  

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Full Text Available ... of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study ... or may compare existing treatments with each other in order to determine which one is safer or ...

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Participating in Clinical Trials  

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Full Text Available ... not intended to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described based on their phase. The U.S. Food and Drug Administration typically requires ...

63

The Kindergarten Clinical Trial  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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 is de...

Janice Weinberg

2009-01-01

64

Clinical Trial Information Management  

Science.gov (United States)

An interoperable clinical trial information technology platform can facilitate the reporting, analysis, and sharing of clinical trial data across sites. Clinical trials using consistent Common Data Elements and standard Case Report Forms modules will improve study start-up times and facilitate data collection. A widely recognized credentialing system can eliminate the need to reestablish credentials for personnel and sites each time a trial is initiated.

65

Flexible manufacturing field trial  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

2009-01-01

66

Skin Cancer - Featured Clinical Trials  

Science.gov (United States)

Skin Cancer - Featured Clinical Trials The following list shows Featured Clinical Trials for a specific type of cancer. You may also want to view: Multiple Cancer Types - Featured Clinical Trials Supportive Care - Featured Clinical Trials

67

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... to clinical trials. Clinical trials currently recruiting research participants are listed at the bottom of this page. ... natural settings. Why participate in a clinical trial? Participants in clinical trials can play a more active ...

68

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... kind of trial being conducted. The clinical trial team includes doctors and nurses as well other health ... of trials, the participant works with a research team. Clinical trial participation is most successful when the ...

69

Thyroid Cancer - Featured Clinical Trials  

Science.gov (United States)

Thyroid Cancer - Featured Clinical Trials The following list shows Featured Clinical Trials for a specific type of cancer. You may also want to view: Multiple Cancer Types - Featured Clinical Trials Supportive Care - Featured Clinical Trials Related

70

Understanding noninferiority trials  

Directory of Open Access Journals (Sweden)

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.

Seokyung Hahn

2012-11-01

71

The Kindergarten Clinical Trial  

Directory of Open Access Journals (Sweden)

Full Text Available 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 is described, and possible additional activities with kindergarteners and older children are discussed.Keywords: clinical trial, role-play, elementary school

Janice Weinberg

2009-11-01

72

Five years of Trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

This editorial marks the launch of a special collection of articles highlighting 'Five years of Trials' (http://www.trialsjournal.com/series/5years). The journal's achievements on its objectives since 2006 are described and some of the challenges still ahead are outlined - in particular further innovating in the reporting of trials and the publication of negative results. The other articles in this series are examples of where Trials has demonstrated progress on its objectives. These include ...

Altman, Douglas G.; Hrynaszkiewicz, Iain; Furberg, Curt D.; Grimshaw, Jeremy M.; Rothwell, Peter M.

2011-01-01

73

Compliance in clinical trials.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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.

1989-01-01

74

Traumeel S® for pain relief following hallux valgus surgery: a randomized controlled trial  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Background In spite of recent advances in post-operative pain relief, pain following orthopedic surgery remains an ongoing challenge for clinicians. We examined whether a well known and frequently prescribed homeopathic preparation could mitigate post-operative pain. Method We performed a randomized, double blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S® in minimizing post-operative pain an...

2010-01-01

75

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 ...

76

A trial bank model for the publication of clinical trials.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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...

Sim, I.; Rennels, G.

1995-01-01

77

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... A BASIC INTRODUCTION TO CLINICAL TRIALS List of Current Clinical Trials/Studies Related to TSC . Also, you ... and benefits in the study compare with my current treatment? How might this trial affect my daily ...

78

What Is a Clinical Trial?  

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Full Text Available ... a clinical trial? Clinical trials evaluate promising new cancer treatments or methods, from radiation and chemotherapy to new surgical techniques. This process helps determine ...

79

Participating in Clinical Trials  

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Full Text Available ... trial is to find out if an experimental drug, therapy, medical device, lifestyle change, or test will ... nutritious foods, can prevent a problem taking certain medicines, or vitamins, or getting vaccines will prevent a ...

80

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 ...

 
 
 
 
81

Participating in Clinical Trials  

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Full Text Available ... safety, the emphasis in Phase 2 is on effectiveness. This phase aims to obtain preliminary data on ... III trial gathers more information about safety and effectiveness, studying different populations and different dosages and using ...

82

Participating in Clinical Trials  

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Full Text Available ... existing treatments with each other in order to determine which one is safer or more effective. The ... 2 and 3 trials to be conducted to determine if the drug can be approved for use. ...

83

Participating in Clinical Trials  

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Full Text Available ... body tissues genetic tests that look for genes linked to some types of disease. Diagnostic Trials In ... on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who ...

84

Comparability of prostate trials  

DEFF Research Database (Denmark)

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

Suciu, S; Sylvester, R

1993-01-01

85

Participating in Clinical Trials  

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Full Text Available ... Researchers may study the role of caregivers, support groups, and various types of social interventions. Supportive care ... trial tests an experimental treatment on a small group of often healthy people (20 to 80), to ...

86

Participating in Clinical Trials  

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

87

Clinical Trials Management  

Science.gov (United States)

The Division of Cancer Prevention supports clinical trials funded by investigator-initiated grants. Investigators using this funding mechanism need to refer to requirements from NCI's Division of Extramural Activities including their publication The Grants Process Book.

88

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... know that the experimental treatment is working? Will results of the trials be provided to me? Who will be in charge of my care? What if I change my mind about participating in the study? Where do the ideas for trials ... promising laboratory results are moved into clinical trials. During a trial, ...

89

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

DEFF Research Database (Denmark)

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

Hare, Kristoffer B; Lohmander, L Stefan

2014-01-01

90

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

Science.gov (United States)

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

2014-01-01

91

Sequential medical trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

A model for sequential clinical trials is discussed. Three proposed stopping rules are studied by the Monte Carlo method for small patient horizons and mathematically for large patient horizons. They are shown to be about equally effective and asymptotically optimal from both Bayesian and frequentist points of view and are markedly superior to any fixed sample size procedure.

Lai, T. L.; Levin, Bruce; Robbins, Herbert; Siegmund, David

1980-01-01

92

Basic Introduction to Clinical Trials  

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Full Text Available ... way to detect certain diseases or health conditions. Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness. What are ...

93

Basic Introduction to Clinical Trials  

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Full Text Available ... TSC Clinics Physician Referral TSC Clinical Trials TSC Natural History Database Tissue Donation Audio & Video Archives State & National ... Opportunities TSC Alert Newsletter Archives Clinical Trials TSC Natural History Database Research Resources International Scientific Advisory Board TSC ...

94

Basic Introduction to Clinical Trials  

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Full Text Available ... way to detect certain diseases or health conditions. Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness. ...

95

Basic Introduction to Clinical Trials  

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Full Text Available ... and well-executed clinical trials provide the best approach for eligible participants to: Play an active role ... experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. Prevention trials look ...

96

Basic Introduction to Clinical Trials  

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Full Text Available ... TSC Clinics Physician Referral TSC Clinical Trials TSC Natural History Database Tissue Donation Audio & Video Archives State & ... Opportunities TSC Alert Newsletter Archives Clinical Trials TSC Natural History Database Research Resources International Scientific Advisory Board ...

97

Basic Introduction to Clinical Trials  

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Full Text Available ... Board TSC Professionals Online Discussion Group Professional Referral List Sign Up TSC Clinics CME Opportunities TS Alliance ... Get Involved A BASIC INTRODUCTION TO CLINICAL TRIALS List of Current Clinical Trials/Studies Related to TSC . ...

98

Basic Introduction to Clinical Trials  

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Full Text Available ... Referral TSC Clinical Trials TSC Natural History Database Tissue Donation Audio & Video Archives State & National Resources Brochures, ... Diagnostic Criteria TSC Consensus Recommendations Publications Clinical Trials Tissue Donation Professional Advisory Board TSC Professionals Online Discussion ...

99

What Is a Clinical Trial?  

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Full Text Available ... milder side effects from their treatment. If trial results warrant, the new treatment becomes standard therapy for ... our cure rates were very low. As a result of clinical trials that have been going on ...

100

Cervical Cancer Prevention Clinical Trials  

Science.gov (United States)

Programs and Projects Cervical Cancer Clinical Trials Ongoing Phase I/II Prevention Trials Funded and Monitored by the Breast and Gynecologic Cancer Research Group (BGCRG) Principal Investigator Funding Mechanism Title of Award

 
 
 
 
101

Basic Introduction to Clinical Trials  

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Full Text Available ... Research Conference Highlights Text Size Get Involved A BASIC INTRODUCTION TO CLINICAL TRIALS List of Current Clinical ... Related to TSC . Also, you can download our "Basic Introduction to Clinical Trials" informational brochure or download ...

102

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, ... returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes. Diagnostic trials are conducted to ...

103

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally ... the study; and if applicable, the schedule of tests, procedures, medications, and dosages. Participants in an interventional ( ...

104

Basic Introduction to Clinical Trials  

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Full Text Available ... Alliance Grants Program Other TSC Funding Opportunities TSC Alert Newsletter Archives Clinical Trials TSC Natural History Database ... Alliance Grants Program Other TSC Funding Opportunities TSC Alert Newsletter Archives Clinical Trials TSC Natural History Database ...

105

Basic Introduction to Clinical Trials  

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Full Text Available ... that work in people and methods to improve health. Interventional trials determine whether experimental treatments or new ... and effective under controlled environments. Observational trials address health issues in large groups of people or populations ...

106

What Is a Clinical Trial?  

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Full Text Available ... is a clinical trial? Clinical trials evaluate promising new cancer treatments or methods, from radiation and chemotherapy to new surgical techniques. This process helps determine if the ...

107

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... National Conference Presentations Clinical Manifestations Diagnostic Criteria TSC Consensus Recommendations Publications Clinical Trials Tissue Donation Professional Advisory ...

108

Traumeel S® for pain relief following hallux valgus surgery: a randomized controlled trial  

Science.gov (United States)

Background In spite of recent advances in post-operative pain relief, pain following orthopedic surgery remains an ongoing challenge for clinicians. We examined whether a well known and frequently prescribed homeopathic preparation could mitigate post-operative pain. Method We performed a randomized, double blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S® in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus. Eighty consecutive patients were randomized to receive either Traumeel tablets or an indistinguishable placebo, and took primary and rescue oral analgesics as needed. Maximum numerical pain scores at rest and consumption of oral analgesics were recorded on day of surgery and for 13 days following surgery. Results Traumeel was not found superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial, however a transient reduction in the daily maximum post-operative pain score favoring the Traumeel arm was observed on the day of surgery, a finding supported by a treatment-time interaction test (p = 0.04). Conclusions Traumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score on the day of surgery is of questionable clinical importance. Trial Registration This study was registered at ClinicalTrials.gov. # NCT00279513

2010-01-01

109

Traumeel S® for pain relief following hallux valgus surgery: a randomized controlled trial  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background In spite of recent advances in post-operative pain relief, pain following orthopedic surgery remains an ongoing challenge for clinicians. We examined whether a well known and frequently prescribed homeopathic preparation could mitigate post-operative pain. Method We performed a randomized, double blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S® in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus. Eighty consecutive patients were randomized to receive either Traumeel tablets or an indistinguishable placebo, and took primary and rescue oral analgesics as needed. Maximum numerical pain scores at rest and consumption of oral analgesics were recorded on day of surgery and for 13 days following surgery. Results Traumeel was not found superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial, however a transient reduction in the daily maximum post-operative pain score favoring the Traumeel arm was observed on the day of surgery, a finding supported by a treatment-time interaction test (p = 0.04. Conclusions Traumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score on the day of surgery is of questionable clinical importance. Trial Registration This study was registered at ClinicalTrials.gov. # NCT00279513

Freedman Laurence

2010-04-01

110

Gateways to clinical trials.  

Science.gov (United States)

Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: ABT-510, adalimumab, alefacept, alemtuzumab, AMG-531, anakinra, armodafinil, asenapine maleate, atazanavir sulfate, atorvastatin; Bortezomib, bosentan; CEB-1555, cetuximab, ciclesonide, clodronate, CT-011; Darifenacin hydrobromide, desloratadine; E-7010, ecallantide, eculizumab, efalizumab, eltrombopag, erlotinib hydrochloride, eslicarbazepine acetate, eszopiclone, ezetimibe; Febuxostat, fosamprenavir calcium, fulvestrant; Gefitinib, genistein; Haemophilus influenzae B vaccine, human papillomavirus vaccine; Imatinib mesylate, insulin glargine; Lenalidomide, liposomal cisplatin; MAb G250, mapatumumab, midostaurin, MP4, mycophenolic acid sodium salt; Natalizumab, neridronic acid, NSC-330507; Oblimersen sodium, ofatumumab, omalizumab, oral insulin, oregovomab; Paliperidone, parathyroid hormone (human recombinant), peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pegylated arginine deiminase 20000, pemetrexed disodium, pimecrolimus, pitavastatin, pneumococcal 7-valent conjugate vaccine, prasterone, pregabalin, pumosetrag hydrochloride; Recombinant malaria vaccine, retigabine, rivaroxaban, Ro-26-9228, romidepsin, rosuvastatin calcium, rotavirus vaccine; SGN-30, sitaxsentan sodium, solifenacin succinate, sorafenib, sunitinib malate; Tadalafil, tegaserod maleate, temsirolimus, TER-199, tifacogin, tiludronic acid, tiotropium bromide; Vildagliptin, VNP-40101M, vorinostat; YM-150, yttrium 90 (90Y) ibritumomab tiuxetan; Zanolimumab, zoledronic acid monohydrate. PMID:16810345

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

2006-04-01

111

Gateways to clinical trials.  

Science.gov (United States)

Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prouse Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 101M, 3F8; Abatacept, ABT-263, Adalimumab, AG-7352, Agatolimod sodium, Alfimeprase, Aliskiren fumarate, Alvimopan hydrate, Aminolevulinic acid hexyl ester, Ammonium tetrathiomolybdate, Anakinra, Aripiprazole, AS-1404, AT-9283, Atomoxetine hydrochloride, AVE-1642, AVE-9633, Axitinib, AZD-0530; Becocalcidiol, Belotecan hydrochloride, Bevacizumab, BG-9928, BIBF-1120, BMS-275183, Bortezomib, Bosentan; Catumaxomab, Cetuximab, CHR-2797, Ciclesonide, Clevidipine, Cypher, Cytarabine/daunorubicin; Darifenacin hydrobromide, Darunavir, Denosumab, Desvenlafaxine succinate, Disufenton sodium, Duloxetine hydrochloride, Dutasteride; Eculizumab, Efalizumab, Eicosapentaenoic acid/docosahexaenoic acid, Eplerenone, Epratuzumab, Erlotinib hydrochloride, Escitalopram oxalate, Ethynylcytidine, Etravirine, Everolimus, Ezetimibe; Fulvestrant; Garenoxacin mesilate, Gefitinib, Gestodene; HI-164, Hydralazine hydrochloride/isosorbide dinitrate; Icatibant acetate, ICX-RHY, Idraparinux sodium, Indacaterol, Ispronicline, Ivabradine hydrochloride, Ixabepilone; KB-2115, KW-2449; L-791515, Lapatinib ditosylate, LGD-4665, Licofelone, Liposomal doxorubicin, Lisdexamfetamine mesilate, Lumiracoxib; Methoxy polyethylene glycol-epoetin-beta, Miglustat, Mipomersen sodium, Mitumprotimut-T, MK-0822A, MK-0974; Nelarabine; Obatoclax mesylate, Olmesartan medoxomil, Olmesartan medoxomil/hydrochlorothiazide; Paliperidone, Palonosetron hydrochloride, Panitumumab, Pegfilgrastim, Peginterferon alfa-2a, Pemetrexed disodium, Perospirone hydrochloride, Pertuzumab, Pimecrolimus, Pitrakinra, Pixantrone maleate, Posaconazole, Pregabalin; Quercetin; RALGA, Raltegravir potassium, Ranelic acid distrontium salt, rhHistone 1.3, Rimonabant, Rivaroxaban, Rosuvastatin calcium, RTS,S/SBAS2; Satraplatin, SNDX-275, Sodium butyrate, Solifenacin succinate, Sorafenib, SU-14813, Sunitinib malate; Tadalafil, Tafenoquine succinate, Tamatinib fosdium, Taxus, Telbivudine, Telmisartan/hydrochlorothiazide, Temsirolimus, Tiotropium bromide, Tipranavir, Tocilizumab, Trabectedin, Tramadol hydrochloride/acetaminophen; Ulipristal acetate, Uracil, Ursodeoxycholyltaurine; Valdecoxib, Vardenafil hydrochloride hydrate, Varenicline tartrate, Vildagliptin, Vinflunine, Vitespen, Vorinostat; ZK-EPO, Zoledronic acid monohydrate. PMID:18389098

Bayés, M; Rabasseda, X

2008-01-01

112

Gateways to clinical trials.  

Science.gov (United States)

Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Intergrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 249553, 2-Methoxyestradiol; Abatacept, Adalimumab, Adefovir dipivoxil, Agalsidase beta, Albinterferon alfa-2b, Aliskiren fumarate, Alovudine, Amdoxovir, Amlodipine besylate/atorvastatin calcium, Amrubicin hydrochloride, Anakinra, AQ-13, Aripiprazole, AS-1404, Asoprisnil, Atacicept, Atrasentan; Belimumab, Bevacizumab, Bortezomib, Bosentan, Botulinum toxin type B, Brivaracetam; Catumaxomab, Cediranib, Cetuximab, cG250, Ciclesonide, Cinacalcet hydrochloride, Curcumin, Cypher; Darbepoetin alfa, Denosumab, Dihydrexidine; Eicosapentaenoic acid/docosahexaenoic acid, Entecavir, Erlotinib hydrochloride, Escitalopram oxalate, Etoricoxib, Everolimus, Ezetimibe; Febuxostat, Fenspiride hydrochloride, Fondaparinux sodium; Gefitinib, Ghrelin (human), GSK-1562902A; HSV-tk/GCV; Iclaprim, Imatinib mesylate, Imexon, Indacaterol, Insulinotropin, ISIS-112989; L-Alanosine, Lapatinib ditosylate, Laropiprant; Methoxy polyethylene glycol-epoetin-beta, Mipomersen sodium, Motexafin gadolinium; Natalizumab, Nimotuzumab; OSC, Ozarelix; PACAP-38, Paclitaxel nanoparticles, Parathyroid Hormone-Related Protein-(1-36), Pasireotide, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Picoplatin, Pimecrolimus, Pitavastatin calcium, Plitidepsin; Ranelic acid distrontium salt, Ranolazine, Recombinant human relaxin H2, Regadenoson, RFB4(dsFv)-PE38, RO-3300074, Rosuvastatin calcium; SIR-Spheres, Solifenacin succinate, Sorafenib, Sunitinib malate; Tadalafil, Talabostat, Taribavirin hydrochloride, Taxus, Temsirolimus, Teriparatide, Tiotropium bromide, Tipifarnib, Tirapazamine, Tocilizumab; UCN-01, Ularitide, Uracil, Ustekinumab; V-260, Vandetanib, Vatalanib succinate, Vernakalant hydrochloride, Vorinostat; YM-155; Zileuton, Zoledronic acid monohydrate. PMID:18200333

Bayés, M; Rabasseda, X; Prous, J R

2007-12-01

113

Gateways to clinical trials.  

Science.gov (United States)

Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort extract, synthetic human secretin; Taxus, telavancin hydrochloride, telithromycin, temoporfin, tenofovir disoproxil fumarate, tenofovir disoproxil fumarate/emtricitabine, teriparatide, testosterone gel, TG-1024, tirapazamine, travoprost, travoprost/timolol; Valdecoxib, valganciclovir hydrochloride, voriconazole; Ximelagatran. PMID:15834452

Bayés, M; Rabasseda, X; Prous, J R

2005-04-01

114

Gateways to clinical trials.  

Science.gov (United States)

Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: AAV1/SERCA2a, Abacavir sulfate/lamivudine, Adalimumab, Aliskiren fumarate, Ambrisentan, Aripiprazole, AT-7519, Atazanavir sulfate, Atomoxetine hydrochloride, Azacitidine, Azelnidipine; Besifloxacin hydrochloride, Bevacizumab, Bioabsorbable everolimus-eluting coronary stent, Bortezomib, Bosentan, Budesonide/formoterol fumarate; CAIV-T, Carisbamate, Casopitant mesylate, Certolizumab pegol, Cetuximab, Ciclesonide, Ciprofloxacin/dexamethasone, CTCE-9908; Dalcetrapib, Darunavir, Deferasirox, Desloratadine, Disitertide, Drotrecogin alfa (activated), DTA-H19, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Efalizumab, Emtricitabine, Eribulin mesilate, Escitalopram oxalate, Eszopiclone, EUR-1008, Everolimus-eluting coronary stent, Exenatide; Fampridine, Fluticasone furoate, Formoterol fumarate/fluticasone propionate, Fosamprenavir calcium, Fulvestrant; Gabapentin enacarbil, GS-7904L; HPV-6/11/16/18, Human Secretin, Hydralazine hydrochloride/isosorbide dinitrate; Imatinib mesylate, Imexon, Inalimarev/Falimarev, Indacaterol, Indacaterol maleate, Inhalable human insulin, Insulin detemir, Insulin glargine, Ixabepilone; L-Alanosine, Lapatinib ditosylate, Lenalidomide, Levocetirizine dihydrochloride, Liraglutide, Lisdexamfetamine mesilate, Lopinavir, Loratadine/montelukast sodium, Lutropin alfa; MeNZB, Mepolizumab, Micafungin sodium, Morphine hydrochloride; Nabiximols, Nikkomycin Z; Olmesartan medoxomil, Omalizumab; Paclitaxel-eluting stent, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Perifosine, PF-489791, Plitidepsin, Posaconazole, Pregabalin; QAX-576; Raltegravir potassium, Ramelteon, Rasagiline mesilate, Recombinant human relaxin H2, rhGAD65, Rivaroxaban, Rosuvastatin calcium, Rotigotine; Saxagliptin, SCH-530348, Sirolimus-eluting stent, SLIT-amikacin, Sorafenib, Sotrastaurin, SR-16234, Sulforaphane; Tadalafil, Tanespimycin, Tapentadol hydrochloride, Teriparatide, Tesofensine, Tiotropium bromide, Tipifarnib, Tirapazamine, TMC-207, Tocilizumab, Tolvaptan, Tosedostat, Treprostinil sodium; Ustekinumab; Varespladib methyl, Vicriviroc, Vildagliptin, Vildagliptin/metformin hydrochloride, Volociximab, Voriconazole; Ziconotide, Ziprasidone hydrochloride. PMID:19907722

Tomillero, A; Moral, M A

2009-09-01

115

Clinical trials in India.  

Science.gov (United States)

The concept of outsourcing for the development and global studies on new drugs has become widely accepted in the pharmaceutical industry due to its cost and uncertainty. India is going to be the most preferred location for contract pharma research and development due to its huge treatment naïve population, human resources, technical skills, adoption/amendment/implementation of rules/laws by regulatory authorities, and changing economic environment. But still 'miles to go' to fulfill the pre-requisites to ensure India's success. In spite of all the pitfalls, the country is ambitious and optimist to attract multinational pharmaceutical companies to conduct their clinical trials in India. PMID:17391981

Maiti, Rituparna; M, Raghavendra

2007-07-01

116

The Trial of Sacco & Vanzetti  

Science.gov (United States)

In 1927, Ferdinando Nicola Sacco and Bartolomeo Vanzetti were executed for the armed robbery of two pay-clerks in South Braintree, Massachusetts in 1920. Their case became a cause celebre across the world, as many felt that their trial was prejudiced by the prevailing anti-immigrant and anti-anarchist sentiment of the time. This collection of documents related to their trial is offered as part of the "Famous Trials" site created by Professor Douglas Linder at the University of Missouri, Kansas City School of Law. Visitors to the site can view a chronology of events, maps, biographies of the trial participants, and statements from the sentencing phase of the trial. Additionally, visitors can also read letters written from Sacco and Vanzetti during their incarceration and also look over a selection of images from their trial. The site is rounded out by a thorough bibliography and a short collection of additional websites.

117

Gateways to clinical trials.  

Science.gov (United States)

Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abacavir sulfate, abciximab, acetylcysteine, adefovir dipivoxil, alfuzosin hydrochloride, aliskiren fumarate, alosetron hydrochloride, amlodipine besilate, apomorphine hydrochloride, atazanavir, atorvastatin, atorvastatin calcium, atrasentan; Basiliximab, beraprost sodium, bevacizumab, bivalirudin, botulinum toxin type A, botulinum toxin type B; Celecoxib, cetuximab, cilansetron, cilomilast; Daclizumab, darbepoetin alfa, docetaxel, duloxetine hydrochloride; Efalizumab, efavirenz, eletriptan,, entecavir, eplerenone, epoetin alfa, eptifibatide, esomeprazole magnesium. ezetimibe; Filgrastim, finasteride, fluvastatin sodium, follitropin alfa; Gemcitabine, gemeprost, ghrelin (human); HE-2000; Infliximab, 111In-Pentetreotide, interferon alfa-2 alpha, interferon alfa-2 beta, interferon beta-1 alpha, irbesartan, irinotecan hydrochloride; Ketamine hydrochloride; L-778123, lafutidine, lamivudine, lamivudine/zidovudine, latanoprost, letrozole, licofelone, lopinavir, losartan potassium, loxiglumide, lubeluzole; Magnesium sulfate, MeGLA, meloxicam, mycophenolate mofetil; NBI-6024, nelfinavir mesilate, nesiritide, nevirapine, niacin, NN-2211; Octreotide, orlistat; PC-515, peginterferon alfa-2 alpha, peginterferon alfa-2b, pemetrexed disodium, pibrozelesin hydrochloride, pimagedine, pirfenidone, pitavastatin calcium, premarin/trimegestone, prucalopride; Rabeprazole sodium; reboxetine, risedronate sodium, ritonavir, rituximab, rofecoxib, roflumilast, rosuvastatin calcium; Sertraline, sibutramine hydrochloride monohydrate, sildenafil citrate, spironolactone, stavudine; Tacrolimus, tadalafil, tamsulosin hydrochloride, tenecteplase, thalidomide, travoprost; Valsartan; Zoledronic acid monohydrate. PMID:12500432

Bayés, M; Rabasseda, X; Prous, J R

2002-10-01

118

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... the Center for Information and Study on Clinical Research Participation (CISCRP). MEDscape News Article on the Recent MILES Trial Sirolimus for Lymphangioleiomyomatosis (requires free online ...

119

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)

1992-01-01

120

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... Summaries Research Teleconference Presentations National Conference Presentations Clinical Manifestations Diagnostic Criteria TSC Consensus Recommendations Publications Clinical Trials Tissue Donation ...

 
 
 
 
121

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

Directory of Open Access Journals (Sweden)

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

T. G. Tolstikova

2006-01-01

122

Dissecting Pamela (and ATIC) with Occam's Razor: existing, well-known Pulsars naturally account for the "anomalous" Cosmic-Ray Electron and Positron Data  

CERN Document Server

We argue that both the positron fraction measured by PAMELA and the peculiar spectral features reported in the total differential electron-positron flux measured by ATIC have a very natural explanation in electron-positron pairs produced by nearby pulsars. We show that the greatly improved quality of current data allow us to reverse-engineer the problem: given the regions of pulsar parameter space favored by PAMELA and by ATIC, are there known pulsars that naturally explain the data? We address this question by (1) outlining simple theoretical models for estimating the energy output, the diffusion setup and the injection spectral index of electron-positron pairs, and by (2) considering all known pulsars (as given in the ATNF catalogue). It appears unlikely that a single pulsar be responsible for both the PAMELA result and for the ATIC excess, although two sources are enough to naturally explain both of the experimental results. We list several candidate pulsars that can individually or coherently contribute t...

Profumo, Stefano

2008-01-01

123

Magnetism in matter before the discovery of quantum spin: Bohr's less well-known contribution to the transition from classical to quantum physics.  

Science.gov (United States)

How does one explain magnetic effects in matter when one views matter as a collection of classical charges in motion? The answer is: not at all! This is one of the points that Niels Bohr made in his doctoral dissertation in 1911, two years before addressing the issue of the stability of the hydrogen atom. The result, later rediscovered by H.J.van Leeuwen was amplified and formalized in Van Vleck's 1932 text on electric and magnetic susceptibilities and it is currently known as the Bohr-van Leeuwen theorem. We will review Bohr's two derivations, one statistical and one based on the motion of individual electrons. We will then propose reasons why this result, unlike that on the stability of hydrogen, did not lead to a major development in quantum theory but, instead, had to wait until after the introduction of spin and exchange forces in quantum mechanics to become generally known.

van Huele, Jean-Francois

2008-03-01

124

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

1990-01-01

125

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)

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.

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

1990-06-01

126

The ability of molecular docking to unravel the controversy and challenges related to P-glycoprotein-a well-known, yet poorly understood drug transporter.  

Science.gov (United States)

P-glycoprotein is the most crucial membrane transporter implicated in tumor resistance. Intensive efforts were paid to elucidate the complex mechanism of transport and to identify modulators of this transporter. However, the borderline between substrates and modulators is very thin and identification of the binding sites within P-glycoprotein is complex. Herein, we provide an intensive review of those issues and use molecular docking to assess its ability: first, to differentiate between three groups (substrates, modulators and non-substrates) and second to identify the binding sites. After thorough statistical analysis, we conclude despite the various challenges that molecular docking should not be underestimated as differences between the distinct groups were significant. However, when it comes to defining the binding site, care must be taken, since consensus throughout literature could not be reached. PMID:24748336

Zeino, Maen; Saeed, Mohamed E M; Kadioglu, Onat; Efferth, Thomas

2014-08-01

127

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

"nMyofibroma is a neoplasia of myofibroblasts that can be solitary or multiple and it is found most commonly in the head & neck region including scalp, forehead, parotid region and oral cavity. In the eyelid it is rarely reported. It has a benign course in the solitary form and fatal in its multiple form. A 4 month male infant referred to Farabi hospital -the referral center for eye diseases- with a 2 month history of a mass in his eyelid with gradual enlargement with no other compla...

Fahimeh Asadi Amoli; Amir Hossein Sina; Aboulfazl Kasai; Zahra Ayan

2010-01-01

128

Gateways to clinical trials.  

Science.gov (United States)

Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com.This issue focuses on the following selection of drugs: ABT-263, AC-2307, Aclidinium bromide, Adefovir dipivoxil, ADH-1, Agatolimod sodium, Alefacept, Aliskiren fumarate, Aminolevulinic acid methyl ester, Anakinra, Apaziquone, Aprepitant, Aripiprazole, ASM-8, Atiprimod hydrochloride, AVE-0277, AVE-1642, AVE-8062, Axitinib, Azacitidine, AZD-0530; Bazedoxifene acetate, Bevacizumab, Bexarotene, BI-2536, Biphasic insulin aspart, BMS-387032, BMS-663513, Bortezomib, BQ-123, Brivanib alaninate, BSI-201; Caspofungin acetate, CDX-110, Cetuximab, Ciclesonide, CR-011, Cypher; Daptomycin, Darbepoetin alfa, Dasatinib, Decitabine, Deferasirox, Denosumab, Dexlansoprazole, Dexmethylphenidate hydrochloride, DNA-Hsp65 vaccine, Dovitinib, Drotrecogin alfa (activated), DTaP-HBV-IPV/Hibvaccine, DTaP-IPV-HB-PRP-T, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Elacytarabine, Emtricitabine, Endothelin, Entecavir, Eplivanserin fumarate, Escitalopram oxalate, Everolimus, Ezetimibe, Ezetimibe/simvastatin; Farletuzumab, Fesoterodine fumarate, Fibrin sealant (human), Fulvestrant; Gefitinib, Gemtuzumab ozogamicin, Glufosfamide, GSK-1562902A; Hib-TT; Imatinib mesylate, IMC-11F8, Imidazoacridinone, IMP-321, INCB-18424, Indiplon, Indisulam, INNO-406, Irinotecan hydrochloride/Floxuridine, ITF-2357, Ixabepilone; KRN-951; Lasofoxifene tartrate; Lenalidomide, LGD-4665, Lonafarnib, Lubiprostone, Lumiliximab; MDX-1100, Melan-A/MART-1/gp100/IFN-alfa, Methyl-CDDO, Metreleptin, MLN-2704, Mycophenolic acid sodium salt; Na-ASP-2, Naproxcinod, Nilotinib hydrochloride monohydrate, NPI-2358; Oblimersen sodium, Odanacatib; Paclitaxel nanoparticles, PAN-811, Panobinostat, PBI-1402, PC-515, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Perillyl alcohol, Perphenazine 4-aminobutyrate, PeviPRO/breast cancer, PF-03814735, PHA-739358, Pimecrolimus, Plitidepsin, Posaconazole, Prasterone, Prasugrel, Pregabalin, Prucalopride, PRX-08066; rAAV2-TNFR:Fc, Ranelic acid distrontium salt, Ranibizumab, rCD154-CLL, Retapamulin, RTS,S/SBAS2, rV-PSA-TRICOM/rF-PSA-TRICOM; SG-2000, Sinecatechins, Sirolimus-eluting stent, Sorafenib, SP-1640, Strontium malonate, Succinobucol, Sunitinib malate; Taxus, Teduglutide, Telavancin hydrochloride, Telbivudine, Telmisartan/hydrochlorothiazide, Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate/emtricitabine, Tocilizumab; Ustekinumab; V-5 Immunitor, Voriconazole, Vorinostat; Xience V, XL-184, XL-647, XL-765; Y-39983, Zibotentan. PMID:18985183

Tomillero, A; Moral, M A

2008-09-01

129

Gateways to clinical trials.  

Science.gov (United States)

Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 131I-labetuzumab; Abacavir sulfate, abatacept, adalimumab, ademetionine, adjuvanted influenza vaccine, alefacept, alemtuzumab, amlodipine, amphotericin B, anakinra, aripiprazole, aspirin, axitinib; Betamethasone dipropionate, bevacizumab, biphasic insulin aspart, bortezomib, bosentan, botulinum toxin type B, BQ-123; Calcium folinate, canertinib dihydrochloride, carboplatin, carmustine, cetirizine hydrochloride, cetuximab, cholecalciferol, ciclesonide, ciclosporin, cinacalcet hydrochloride, cisplatin, clarithromycin, clofazimine, cold-adapted influenza vaccine trivalent, CpG-7909; Darbepoetin alfa, darifenacin hydrobromide, DB-289, desloratadine, Dexamet, dicycloverine hydrochloride, dimethyl fumarate, docetaxel, dolastatin 10, drospirenone, drospirenone/estradiol, duloxetine hydrochloride; Ecogramostim, edotecarin, efaproxiral sodium, enalapril maleate, epoetin beta, epoprostenol sodium, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, estradiol, etanercept; Fluconazole, fludarabine phosphate, fluorouracil; Gefitinib, gemcitabine, Ghrelin (human), glibenclamide, glimepiride, GTI-2040; Haloperidol, human insulin, hydrocortisone probutate; Imatinib mesylate, indisulam, influenza vaccine, inhaled insulin, insulin aspart, insulin glulisine, insulin lispro, irinotecan, ispronicline; Lamivudine, lamivudine/zidovudine/abacavir sulfate, lapatinib, letrozole, levocetirizine, lomustine, lonafarnib, lumiracoxib;Magnesium sulfate, MD-1100, melphalan, metformin hydrochloride, methotrexate, metoclopramide hydrochloride, mitiglinide calcium hydrate, monophosphoryl lipid A, montelukast sodium, motexafin gadolinium, mycophenolate mofetil, mycophenolic acid sodium salt; Nitisinone; Omalizumab, omapatrilat, ONYX-015, oxaliplatin; Paclitaxel, paclitaxel nanoparticles, panitumumab, parathyroid hormone (human recombinant), peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pertuzumab, phosphatidylcholine-rich phospholipid mixture, pimecrolimus, pioglitazone hydrochloride, pramlintide acetate, prasterone; QR-333; Ranelic acid distrontium salt, ranolazine, rasagiline mesilate, RFB4(dsFv)-PE38, ribavirin, rifabutin, risperidone, rituximab, rofecoxib, rosiglitazone maleate, rosiglitazone maleate/metformin hydrochloride, rotavirus vaccine; S-236, salmeterol xinafoate, sarizotan hydrochloride, sildenafil, sildenafil citrate, sunitinib malate; Tadalafil, tegaserod maleate, temozolomide, tenofovir disoproxil fumarate, teriparatide, tiotropium bromide, tipifarnib, trabectedin, treprostinil sodium; Vandetanib, vardenafil hydrochloride hydrate, vatalanib succinate, vinflunine, virosome influenza vaccine, voriconazole; Zidovudine. PMID:16636723

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

2006-03-01

130

Electromagnetic Radiation: On Trial  

Science.gov (United States)

This activity introduces students to the properties of electromagnetic radiation in a variety of ways. For example, they put the different types of the electromagnetic radiation on trial, selecting the judge, prosecutor, defense counsel, and jury, and learning about electromagnetic energy by arguing the pros and cons of each wavelength. During this activity, students are introduced to the general properties of electromagnetic waves, learn to analyze the relation between the specific properties of waves and their position in the electromagnetic spectrum, and discuss methods used to detect and analyze different waves. Students also learn about scientists whose work contributed to our understanding of electromagnetic energy. Students are encouraged to use an electronic bulletin board to communicate with each other, posting insights, ideas, evidence and questions on electromagnetic energy.

2007-05-16

131

What Is a Clinical Trial?  

Medline Plus

Full Text Available ... a clinical trial? Clinical trials evaluate promising new cancer treatments or methods, from radiation and chemotherapy to new ... re considering. Of course, no patient with active cancer ever receives treatment known to be inferior. In fact, all clinical ...

132

How Do Clinical Trials Protect Participants?  

Science.gov (United States)

... NHLBI on Twitter. How Do Clinical Trials Protect Participants? Protecting the safety of people who take part ... that clinical trials are ethical and that the participants' rights are protected. The IRB reviews the trial's ...

133

Frailty Intervention Trial (FIT  

Directory of Open Access Journals (Sweden)

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.

Lockwood Keri

2008-10-01

134

Quality Assurance for Clinical Trials  

Science.gov (United States)

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

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

2013-01-01

135

Sequential boundaries approach in clinical trials with unequal allocation ratios  

Directory of Open Access Journals (Sweden)

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

Ayatollahi Seyyed

2006-01-01

136

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for ... Others Ways to Give Volunteer Sign-Up Form Special Events TSC Connect Outreach & Awareness Tools Government Relations ...

137

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... Resources Young Adult Resources Family Support TSC Connect Publications & Information Sheets TSC Clinics Physician Referral TSC Clinical ... Presentations Clinical Manifestations Diagnostic Criteria TSC Consensus Recommendations Publications Clinical Trials Tissue Donation Professional Advisory Board TSC ...

138

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... Adult Resources Family Support TSC Connect Publications & Information Sheets TSC Clinics Physician Referral TSC Clinical Trials TSC ... Archives State & National Resources Brochures, Books, & Booklets Information Sheets Perspective Magazine Archives Life Stages Guides & Personal Journals ...

139

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... Newsletter Archives Clinical Trials TSC Natural History Database Research Resources International Scientific Advisory Board Tuberous Sclerosis Alliance Support Community Top-Rated Nonprofit by GreatNonprofits Member of the National Organization for Rare Disease America's ...

140

What Is a Clinical Trial?  

Medline Plus

Full Text Available ... The new therapy is compared directly to existing standard therapy, to discover if the new therapy does, ... If trial results warrant, the new treatment becomes standard therapy for all patients. Dr. Stanley Watkins provides ...

 
 
 
 
141

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... effectiveness of a drug, biologic (such as a vaccine), device (such as prosthesis) or other treatment or ... from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes. Diagnostic trials are conducted ...

142

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... a research study using human volunteers designed to determine the safety and effectiveness of a drug, biologic ( ... people and methods to improve health. Interventional trials determine whether experimental treatments or new ways of using ...

143

What Is a Clinical Trial?  

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Full Text Available ... and the duration of the patient's life, the quality of their life, has changed dramatically. As a ... fact, all clinical trial patients receive the highest quality medical care, with thorough, careful monitoring during the ...

144

What Is a Clinical Trial?  

Medline Plus

Full Text Available ... clinical trial, you must sign an informed consent statement. This statement means you understand what treatments you may receive, ... responsibility and possible outcomes. So before signing this statement, be sure to learn all you can about ...

145

Measuring cancer clinical trial understanding.  

Science.gov (United States)

Researchers, practitioners, and participants in cancer clinical trials must have a clear understanding of clinical trials if participation in them is to be solicited ethically and effectively. A valid and reliable measure of cancer clinical trial understanding did not exist prior to a 2005 study conducted for the Coalition of Cooperative Cancer Groups. This report outlines a measure derived from that study, discusses the rationale for its component items, examines its psychometric properties, and demonstrates the relationship of this measure to the enrollment decision. Data from national samples of cancer survivors and the general public demonstrate the measure's validity and reliability. Results are discussed as they relate to patient understanding of clinical trials, informed decision making, and health communication processes. PMID:21218302

Miller, Jon D; Kotowski, Michael R; Comis, Robert L; Smith, Sandi W; Silk, Kami J; Colaizzi, Diane D; Kimmel, Linda G

2011-01-01

146

ADS Europe Flight Trials Programme.  

Science.gov (United States)

The world's largest trial of satellite based Automatic Dependent Surveillance (ADS) in the ICAO Aeronautical Telecommunications Network standard environment is being executed in Europe. A Consortium, led by the United Kingdom's National Air Traffic Servic...

S. S. van Leeuwen

1996-01-01

147

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups ... type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical ...

148

What Is a Clinical Trial?  

Medline Plus

Full Text Available ... treatment is an improvement over existing treatments. For patients' safety, new treatments are developed in phases. Initially, ... they open clinical trials to large numbers of patients for the final test phase. The new therapy ...

149

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... If a participant is a non-English speaking person, federal guidelines require a version of the consent ... experimental or control) to participate in? No, each person who agrees to participate in a clinical trial ...

150

Clinical Trials and Older People  

Science.gov (United States)

... studies. Also, newspapers in large cities may have advertisements for clinical trials at nearby hospitals, clinics, or ... the control group or the treatment group. Side effects —undesirable or adverse effects caused by a treatment. ...

151

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... website that provides regularly updated information about clinical research in human volunteers -- www.clinicaltrials.gov , where you will find additional links to other medical research resources, such as: Access to all clinical trials ...

152

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... know (or the research team knows) that I am in the experimental or control/placebo group? Knowledge ... How long will the trial last? If I am assigned to a control or placebo group, will ...

153

Public Assistance Worker Job Trial.  

Science.gov (United States)

The Public Assistance Worker Job Trial was developed for use as a personnel selection tool for the position of Income Maintenance Worker Trainee within the Pennsylvania Department of Public Welfare. This report outlines the steps taken to develop and cons...

A. I. Fiks H. P. Bawden S. W. Davies J. D. Gaspari A. M. Meek

1976-01-01

154

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and ... in their own health care, gain access to new research treatments before they are widely available, and ...

155

Informative noncompliance in endpoint trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Noncompliance with study medications is an important issue in the design of endpoint clinical trials. Including noncompliant patient data in an intention-to-treat analysis could seriously decrease study power. Standard methods for calculating sample size account for noncompliance, but all assume that noncompliance is noninformative, i.e., that the risk of discontinuation is independent of the risk of experiencing a study endpoint. Using data from several published clinical trials (OPTIMAAL, L...

Snapinn, Steven M.; Jiang, Qi; Iglewicz, Boris

2004-01-01

156

Collaborative trial on groundwater sampling  

Digital Repository Infrastructure Vision for European Research (DRIVER)

The trial presented here was conducted by BRGM in collaboration with LNE under the work program AQUAREF 2009 with the support of ONEMA. This is a collaborative trial on groundwater sampling and on field physico chemical measurement. It is not a proficiency test. He had three goals: * Observe and evaluate the practices of groundwater sampling to improve future guides, standards and specifications. * Assess the impact of sampling on variability of results. * Study the accuracy of field measurem...

Ghestem, Jean Philippe; Fisicaro, Paula; Champion, Rachel

2011-01-01

157

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

1992-04-01

158

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

Directory of Open Access Journals (Sweden)

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

Xie Cheng-long

2013-01-01

159

Phase II Cancer Prevention Clinical Trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

The development of agents to prevent cancer requires an iterative process of target identification, preclinical testing, and early and late phase clinical trials to establish efficacy and safety. Since phase III definitive efficacy trials with cancer endpoints require a lengthy timeframe and considerable resources for completion, it is critical to first optimize agent delivery and trial design and to determine preliminary efficacy via the conduct of phase II trials. Phase II trials vary consi...

2010-01-01

160

Endpoints in cancer clinical trials.  

Science.gov (United States)

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

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

2014-02-01

 
 
 
 
161

Clinical trials on AIDS start.  

Science.gov (United States)

A 6-month clinical trial in the Philippines sought to determine the efficacy of coconut oil and of "monolaurin," a coconut oil byproduct, in killing HIV by breaking down its coating. This research is based on the theory that medium-chain fatty acids, like monolaurin, can have this effect on certain viruses. The trial involves 12 women and 3 men in the early stage of HIV infection. 10 patients will take different doses of monolaurin, and 5 will consume coconut oil. It is hypothesized that the regimen will lead to higher CD4 counts and a lower viral load. The trial was almost abandoned because it received only lukewarm approval from the Health Secretary. PMID:12349090

162

A review of international clinical trial registration  

Directory of Open Access Journals (Sweden)

Full Text Available 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 of clinical trial registration. This review briefly introduced the definition, justification, contents, history, current status of clinical trial registration, and introduced the information regarding important international clinical trial registries in detail. Clinical trial registration should be developed toward a transparent, compulsory and comprehensive stage

He YU

2007-05-01

163

Jury discrimination in criminal trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

This paper examines the impact of jury racial composition on trial outcomes using a unique dataset of all felony trials in Sarasota County, Florida between 2004 and 2009. We utilize a research design that exploits day-to-day variation in the composition of the jury pool to isolate quasi-random variation in the composition of the seated jury. We find strong evidence that all-white juries acquit whites more often and are less favorable to black versus white defendants when compared to juries wi...

Anwar, Shamena; Bayer, Patrick; Hjalmarsson, Randi

2010-01-01

164

National Lung Screening Trial (NLST)  

Science.gov (United States)

A collection of material about 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.

165

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... each person who agrees to participate in a clinical trial that compares an experimental medicine or device with a standard treatment or placebo ... Health (NIH) is the U.S. National Library of Medicine (NLM). The NLM developed a ... research in human volunteers -- www.clinicaltrials.gov , where ...

166

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... Overview Outreach Toolkit Government Action Team TS Alliance Online Support Community Facebook Twitter YouTube CaringBridge How to Make a ... Clinical Trials Tissue Donation Professional Advisory Board Professional Online Discussion ... Top-Rated Nonprofit by GreatNonprofits Member of the ...

167

What Is a Clinical Trial?  

Medline Plus

Full Text Available ... and see whether the treatment has any harmful effects. A second phase determines the effects of research treatmenton various types of cancer. Once ... active life, or experience fewer and milder side effects from their treatment. If trial results warrant, the ...

168

2012 Consortia for Early Phase Prevention Trials  

Science.gov (United States)

DCP Consortia for Early Phase Trials 2012 Consortia for Early Phase Prevention Trials Standard Operating Procedures (SOP), Consortia 2012 (DOC, 500KB) (All SOP Documents with Table of Contents) DCP Acronym List, Consortia 2012 (DOC, 63KB)

169

Microbicide clinical trial adherence: insights for introduction  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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...

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

2013-01-01

170

Sample Size Estimation in Clinical Trial  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Every clinical trial should be planned. This plan should include the objective of trial, primary and secondary end-point, method of collecting data, sample to be included, sample size with scientific justification, method of handling data, statistical methods and assumptions. This plan is termed as clinical trial protocol. One of the key aspects of this protocol is sample size estimation. The aim of this article is to discuss how important sample size estimation is for a clinical trial, and a...

Sakpal, Tushar Vijay

2010-01-01

171

Optimising the analysis of stroke trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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.

2008-01-01

172

Denoising of single-trial matrix representations using 2D nonlinear diffusion filtering.  

Science.gov (United States)

In this paper we present a novel application of denoising by means of nonlinear diffusion filters (NDFs). NDFs have been successfully applied for image processing and computer vision areas, particularly in image denoising, smoothing, segmentation, and restoration. We apply two types of NDFs for the denoising of evoked responses in single-trials in a matrix form, the nonlinear isotropic and the anisotropic diffusion filters. We show that by means of NDFs we are able to denoise the evoked potentials resulting in a better extraction of physiologically relevant morphological features over the ongoing experiment. This technique offers the advantage of translation-invariance in comparison to other well-known methods, e.g., wavelet denoising based on maximally decimated filter banks, due to an adaptive diffusion feature. We compare the proposed technique with a wavelet denoising scheme that had been introduced before for evoked responses. It is concluded that NDFs represent a promising and useful approach in the denoising of event related potentials. Novel NDF applications of single-trials of auditory brain responses (ABRs) and the transcranial magnetic stimulation (TMS) evoked electroencephalographic responses denoising are presented in this paper. PMID:19819259

Mustaffa, I; Trenado, C; Schwerdtfeger, K; Strauss, D J

2010-01-15

173

GPON FTTH trial: lessons learned  

Science.gov (United States)

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.

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

2009-11-01

174

Potential Representation - Global vs. Local Trial Functions  

Science.gov (United States)

Many systems of trial functions are available for representing potential fields on the sphere or parts of the sphere. We distinguish global trial functions (such as spherical harmonics) from localized trial functions (such as spline basis functions, scaling functions, wavelets, and Slepian functions). All these systems have their own pros and cons. We discuss the advantages and disadvantages of several selected systems of trial functions and propose criteria for their applicability. Moreover, we present an algorithm which is able to combine different types of trial functions. This yields a sparser solution which combines the features of the different basis systems which are used.

Michel, Volker

2014-05-01

175

COMPETING COMMITMENTS in CLINICAL TRIALS  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

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

2009-01-01

176

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

Directory of Open Access Journals (Sweden)

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.

Daly Fergus

2007-03-01

177

Some statistical issues in HIV vaccine trials.  

Science.gov (United States)

Efficacy trials of prophylactic HIV vaccines will be among the most difficult clinical trials ever attempted. Not only will there be challenges with the recruitment and retention of high-risk uninfected individuals, there will be many statistical challenges to the design, conduct, analysis, and interpretation of these trials. General features of an efficacy trial are described, including choice for the primary endpoint and testing for and estimating vaccine efficacy. Secondary objectives of trials are also discussed. These include determining the correlates of protective immunity, assessing the impact of HIV genetic variation on vaccine efficacy, and using biological markers such as viral load and CD4+ lymphocyte cell count to gain insight on a vaccine's ability to prevent or delay disease. The use of biological markers as surrogates for disease outcome is discussed. Last, trial designs for studying several candidate vaccines or other HIV prevention strategies in a single trial are examined. PMID:7846417

Rida, W N; Lawrence, D N

178

Impact of a clinical trial initiative on clinical trial enrollment in a multidisciplinary prostate cancer clinic.  

Science.gov (United States)

Clinical oncology trials are hampered by low accrual rates, with fewer than 5% of adult patients with cancer treated on study. Clinical trial enrollment was evaluated at The University of Texas MD Anderson Cancer Center's Multidisciplinary Prostate Cancer Clinic (MPCC) to assess whether a clinical trial initiative, introduced in 2006, impacted enrollment. The trial initiative included posting trial-specific information in clinic, educating patients about appropriate clinical trial options during the treatment recommendation discussion, and providing patients with trial-specific educational information. The investigators evaluated the frequency of clinical trial enrollment for men with newly diagnosed prostate cancer seen in the MPCC from 2004 to 2008. Logistic regression evaluated the impact of patient characteristics and the clinical trial initiative on trial enrollment. The median age of the 1370 men was 64 years; 32% had low-risk, 49% had intermediate-risk, and 19% had high-risk disease. Overall, 74% enrolled in at least one trial and 29% enrolled in more than one trial. Trial enrollment increased from 39% before the initiative (127/326) to 84% (880/1044) after the trial initiative. Patient enrollment increased in laboratory studies (from 25% to 80%), quality-of-life studies (from 10% to 26%), and studies evaluating investigational treatments and systemic agents (from 6% to 15%) after the trial initiative. In multivariate analysis, younger men (Pimplementation of the clinical trial initiative (P<.001) were more likely to enroll in trials. Clinical trial enrollment in the MPCC was substantially higher than that seen nationally in adult patients with cancer, and enrollment rates increased after the introduction of a clinical trial initiative. PMID:24994920

Madsen, Lydia T; Kuban, Deborah A; Choi, Seungtaek; Davis, John W; Kim, Jeri; Lee, Andrew K; Domain, Delora; Levy, Larry; Pisters, Louis L; Pettaway, Curtis A; Ward, John F; Logothetis, Christopher; Hoffman, Karen E

2014-07-01

179

Application of a kinematic GPS to ship maneuvering trials; Soju seino shiken eno kinematic GPS no riyo ni tsuite  

Energy Technology Data Exchange (ETDEWEB)

There has been a great progress in position measurement capability of well-known Global Positioning Systems (GPS) and the accuracy has been remarkably improved in the cm order, especially in a kinematic GPS (KGPS) which is based on the phase identification of GPS carrier waves. For the KGPS, interference measurement type differential GPS (DGPS) can be applied to moving ship. Accuracy of the KGPS has been examined. The sea trials of the coastal cargo ship have been conducted for grasping the performance improvement during trials by means of the KGPS. High accuracy in the measurements was evaluated about 2 cm horizontally and 5 cm vertically. The accuracy was occasionally degraded by the cycle slip generated with multi-pass and radio cutout. It is required to consider the setting position of antennas. Although the KGPS can determine the position in remarkably high accuracy, the direction can not be determined from a single measurement. It is required to determine the angle by combining the measurements. From the measurements during ship maneuvering trials using the KGPS, it was found that information required for evaluating the maneuvering performance, such as longitudinal and lateral velocities, turning angle velocity, and yawing angle, can be accurately determined. 5 refs., 8 figs., 5 tabs.

Hirata, N.; Kose, K.; Takase, S.; Ito, R. [Hiroshima University, Hiroshima (Japan). Faculty of Engineering; Nakamura, Y.; Terada, K.

1997-09-04

180

Microbicide clinical trial adherence: insights for introduction  

Directory of Open Access Journals (Sweden)

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.

Cynthia Woodsong

2013-04-01

 
 
 
 
181

Microbicide clinical trial adherence: insights for introduction  

Science.gov (United States)

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.

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

2013-01-01

182

The hidden effects of blinded, placebo-controlled randomized trials: an experimental investigation.  

Science.gov (United States)

The knowledge of having only a 50% chance of receiving an active drug can result in reduced efficacy in blinded randomized clinical trials (RCTs) compared to clinical practice (reduced external validity). Moreover, minor onset sensations associated with the drug (but not with an inert placebo) can further challenge the attribution of group differences to drug-specific efficacy (internal validity). We used a randomized experimental study with inert placebos (inert substance) vs active placebos (inducing minor sensations), and different instructions about group allocation (probability of receiving drug: 0%, 50%, 100%). One hundred forty-four healthy volunteers were informed that a new application method for a well-known painkiller would be tested. Pain thresholds were assessed before and after receiving nasal spray. Half of the nasal sprays were inert placebos (sesame oil), while the other half were active placebos inducing prickling nasal sensations (sesame oil with 0.014% capsaicin). The major outcome was pain threshold after placebo application. A substantial expectation effect was found for the inert placebo condition, with participants who believed they had received an active drug reporting the highest pain thresholds. Active placebos show substantial differences to passive placebos in the 50% chance group. Therefore, patient expectations are significantly different in placebo-controlled clinical trials (50% chance) vs clinical practice (100% chance). Moreover, minor drug onset sensations can challenge internal validity. Effect sizes for these mechanisms are medium, and can substantially compete with specific drug effects. For clinical trials, new study designs are needed that better control for these effects. PMID:23084328

Rief, Winfried; Glombiewski, Julia A

2012-12-01

183

Composite endpoints in clinical trials.  

Science.gov (United States)

Composite endpoints are often used in clinical trials, especially in the cardiovascular area. Decreases in sample size requirements, ability to assess the net effect of an intervention and to avoid bias in presence of competing risks are the most cited advantages for their use. However, there is a risk of misinterpretation when heterogeneity among components with respect to either importance, number of events, or magnitude of treatment effect exist. In the following review we present a conceptual discussion about the rationale and interpretation of such variables. Also, a user's friendly guide to interpret the results of clinical trials based on composite endpoints is presented. We also present an empirical study that provides evidence of the use of misleading composite endpoints in cardiovascular clinical trials. Las variables de resultado combinadas en los ensayos clinicos son un recurso metodologico usado con frecuencia, especialmente en los estudios cardiovasculares. Las motivaciones más importantes para su utilizacion son aumentar la potencia estadística del estudio, valorar el beneficio neto de una intervencion y evitar una interpretacion errónea del resultado en presencia de riesgos competitivos. Sin embargo, su interpretación puede ser problemática si hay heterogeneidad entre los componentes en cuanto a su importancia, la frecuencia de eventos o el efecto de la intervencion. En la discusión que sigue se presenta un revisión conceptual de los problemas del uso y la interpretación de las variables de resultado combinadas en ensayos clinicos, especialmente los cardiovasculares. Se presenta además una sencilla guia de interpretacion de los resultados de los estudios que utilizan variables de resultado combinadas a partir de la cual se puede valorar nuestra confianza en dichos resultados. Finalmente, se presenta un estudio empírico sobre cuál ha sido el uso real de variables de resultado combinadas potencialmente problemáticas en ensayos clinicos cardiovasculares. PMID:24775785

Ferreira-González, Ignacio; Alonso-Coello, Pablo; Solà, Ivan; Pacheco-Huergo, Valeria; Domingo-Salvany, Antónia; Alonso, Jordi; Montori, Víctor; Permanyer-Miralda, Gaietá

2008-01-01

184

Registration of noncommercial randomised clinical trials: the feasibility of using trial registries to monitor the number of trials  

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Full Text Available Abstract Background A 2003 survey suggested the number of noncommercial trials in the UK was declining. Formation of the NIHR in 2006 and increased research spending by the Department of Health may have increased the number of noncommercial trials but no data are available. Methods Available data on UK noncommercial trials (were obtained from the two relevant registries: ISRCTN register for the UK, and US ClinicalTrials.gov. Data on each trial were sorted by start year, and compared with the: 2003 survey, and UKCRN portfolio database from 2007. Results The number of UK noncommercial trials registered rose from 25 in 1990 to 188 in 1999, peaked at 533 in 2003, and fell back to 334 in 2009. Total trials registered was similar to but slightly above those in the 2003 survey up to 1998, then rose sharply to 2002 before falling to 2007. From 2007 to 2009 the number registered to start each year was similar to but slightly above the UKCRN database. Less than 10% of UK noncommercial trials registered with ClinGov for most years before 2005, but this rose to 35% by 2009. Conclusions For the periods of overlap, trial registration data provide fairly similar totals to other sources on the number of noncommercial trials starting each year. The rise and fall in the number of trials registered between 1999 and 2007 was due to those registered in the ISRCTN database as funded by NHS Trusts. After 2007, the number of trials registered as funded by NHS Trusts has fallen in the ISRCTN register but these trials may have migrated to the US ClinGov register. The total number of noncommercial trial starts, excluding those funded by NHS Trusts, has been upward since around 2002. By 2009 the two main funders were NIHR and charities. Feasibility of using registration data to monitor the number of noncommercial trials has been demonstrated but is complicated by the use of two registers and difficulties in accessing the data. We recommend an annual report on the number of noncommercial trials registering each year.

Raftery James

2012-08-01

185

Mobiilipeligrafiikan optimointi : Case: Trials Frontier  

Digital Repository Infrastructure Vision for European Research (DRIVER)

The aim of this study is to highlight the most important aspects and techniques of game graphics optimizations from the 3D-graphic artist’s point of view. The techniques I learned relate closely to the Trials Frontier - mobile game, which is under development at Redlynx Ubisoft -studios at the time this thesis is being written. I work as a 3d graphic artist in this project and I have created most of the 3d-objects and textures for this game. During this project I have come across many techn...

2013-01-01

186

Protocol and data INCA trial  

Digital Repository Infrastructure Vision for European Research (DRIVER)

The file INCAdata.csv contains the data collected during the INCA study (100 records with 152 variables). The data have been analysed and outcomes were published by Pelsser et al (2011): "Effects of a restricted elimination diet on the behaviour of children with attention-deficit hyperactivity disorder (INCA study): a randomised controlled trial." The Lancet 377: 494-503 (doi:10.1016/S0140-6736(10)62227-1). Further explanation of the variable abbreviations is in the file INCAvar.csv while the...

Pelsser, L. M.; Frankena, K.; Toorman, J.; Savelkoul, H. F. J.; Dubois, A. E. J.; Rodrigues Pereira, R.; Haagen, T. A.; Rommelse, N. N.; Buitelaar, J. K.

2012-01-01

187

Trial burns for hazardous waste incinerators  

Energy Technology Data Exchange (ETDEWEB)

This guide concentrates on those aspects of a trial burn that are the most important and those that are potentially troublesome. It contains practical explanations based on experience of Midwest Research Institute (MRI) and others in conducting trial burns and related tests for EPA. Comments of several industrial plant owners and operators are included in the Guide. It is directed mainly to incinerator operators, those who may conduct the actual sampling and analysis and those who must interpret trial burn results, but it will also be useful for regulatory personnel and others who need to understand trial burns. Potential trouble spots that have been encountered are: (1) trial burns frequently take more time and effort than an operator anticipates and (2) failure to meet the trial burn requirements.

Gorman, P.; Hathaway, R.; Wallace, D.; Trenholm, A.

1987-01-01

188

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

Directory of Open Access Journals (Sweden)

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

JoshuaCarp

2013-09-01

189

Five years of Trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract This editorial marks the launch of a special collection of articles highlighting 'Five years of Trials' (http://www.trialsjournal.com/series/5years). The journal's achievements on its objectives since 2006 are described and some of the challenges still ahead are outlined - in particular further innovating in the reporting of trials and the publication of negative results. The other articles in this series are examples of where Trials has demonst...

Altman Douglas G; Hrynaszkiewicz Iain; Furberg Curt D; Grimshaw Jeremy M; Rothwell Peter M

2011-01-01

190

Registro dos ensaios clínicos / Clinical trials register  

Scientific Electronic Library Online (English)

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

Carlos Alberto, Guimarães.

191

How should zoster trials be conducted?  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

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

1995-01-01

192

Randomized Clinical Trials in Stroke Research  

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A randomized clinical trial (RCT) is widely regarded as the most rigorous study design to determine the efficacy of intervention since spurious causality and bias associated with other experimental designs can be avoided. The purpose of this article is to provide clinicians and clinical researchers with the types of randomized clinical trials used in stroke studies and to discuss the advantages and limitations in each type of randomized stroke clinical trials.

Ahn, Chul; Ahn, Daniel

2010-01-01

193

[Randomized controlled trials in psychiatry].  

Science.gov (United States)

In the past twenty years, evidence based medicine (EBM) has become a dominant paradigm of the contemporary medical practice. Since the emergence of the significant article by Geddes and Harrison in 1997, this doctrine has become part of psychiatry too. According to the rules of EBM, the most valuable clinical data comes from randomized-controlled trials (RCT). Nevertheless there are numerous researchers who point out at some limitations making RCT less valid in psychiatry than in other medical disciplines. The authors of this paper reviewed the available literature on the place of RCT in psychiatry and subsequently presented current opinions about the reliability of those trials, as well as highlighted the possible solutions of potential controversies. We suggest that in spite of the limitations mentioned above, RCT remains the most valuable research strategy in psychiatry. Most of the obstacles do not differ significantly from the problems seen in other medical fields. There are also known methods of improving methodology of RCT (such as recruiting larger groups of patients or performing expertise-based RCT). PMID:23214154

Jaeschke, Rafa?; Siwek, Marcin; Brozek, Jan; Brudkiewicz, Pawe?

2012-01-01

194

Developing clinical trials for biosimilars.  

Science.gov (United States)

Biosimilars offer the prospect of providing efficacious and safe treatment options for many diseases, including cancer, while potentially increasing accessibility with greater affordability relative to biologics. Because biologics are large, complex molecules that cannot be exactly duplicated, biosimilars cannot be considered "generic" versions of biologic drugs. This review will examine important considerations for biosimilar clinical trials. Since the aim of biosimilar manufacturing is to produce a molecule highly similar to the reference biologic, a comparability exercise is needed to demonstrate similarity with the reference biologic product based on physicochemical characterization. In vitro analytical studies and in vivo studies as well as pharmacokinetic/pharmacodynamic (PK/PD) assessments also are conducted. Lastly, because it may not be possible to fully characterize a biosimilar in relation to its reference biologic, robust pharmacovigilance strategies are utilized to ensure that any matters in regard to safety can be monitored. Other key topics will be discussed, including regulatory guidance for the evaluation of biosimilars, clinical trial design considerations, and whether data submitted for the approval of a biosimilar for one indication can be extrapolated to other indications for which the reference biologic is approved. European and Canadian experiences in biosimilar development will be reviewed. PMID:24560024

Bui, Lynne A; Taylor, Carrie

2014-02-01

195

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.

196

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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 trial...

Treweek Shaun; Zwarenstein Merrick

2009-01-01

197

Resistant hypertension optimal treatment trial: a randomized controlled trial.  

Science.gov (United States)

The prevalence of resistant hypertension (ReHy) is not well established. Furthermore, diuretics, angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers, and calcium channel blockers are largely used as the first 3-drug combinations for treating ReHy. However, the fourth drug to be added to the triple regimen is still controversial and guided by empirical choices. We sought (1) to determine the prevalence of ReHy in patients with stage II hypertension; (2) to compare the effects of spironolactone vs clonidine, when added to the triple regimen; and (3) to evaluate the role of measuring sympathetic and renin-angiotensin-aldosterone activities in predicting blood pressure response to spironolactone or clonidine. The Resistant Hypertension Optimal Treatment (ReHOT) study (ClinicalTrials.gov NCT01643434) is a prospective, multicenter, randomized trial comprising 26 sites in Brazil. In step 1, 2000 patients will be treated according to hypertension guidelines for 12 weeks, to detect the prevalence of ReHy. Medical therapy adherence will be checked by pill count monitoring. In step 2, patients with confirmed ReHy will be randomized to an open label 3-month treatment with spironolactone (titrating dose, 12.5-50 mg once daily) or clonidine (titrating dose, 0.1-0.3 mg twice daily). The primary endpoint is the effective control of blood pressure after a 12-week randomized period of treatment. The ReHOT study will disseminate results about the prevalence of ReHy in stage II hypertension and the comparison of spironolactone vs clonidine for blood pressure control in patients with ReHy under 3-drug standard regimen. PMID:24338935

Krieger, Eduardo M; Drager, Luciano F; Giorgi, Dante Marcelo Artigas; Krieger, Jose Eduardo; Pereira, Alexandre Costa; Barreto-Filho, José Augusto Soares; da Rocha Nogueira, Armando; Mill, José Geraldo

2014-01-01

198

Increasing recruitment to randomised trials: a review of randomised controlled trials  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Poor recruitment to randomised controlled trials (RCTs is a widespread and important problem. With poor recruitment being such an important issue with respect to the conduct of randomised trials, a systematic review of controlled trials on recruitment methods was undertaken in order to identify strategies that are effective. Methods We searched the register of trials in Cochrane library from 1996 to end of 2004. We also searched Web of Science for 2004. Additional trials were identified from personal knowledge. Included studies had to use random allocation and participants had to be allocated to different methods of recruitment to a 'real' randomised trial. Trials that randomised participants to 'mock' trials and trials of recruitment to non-randomised studies (e.g., case control studies were excluded. Information on the study design, intervention and control, and number of patients recruited was extracted by the 2 authors. Results We identified 14 papers describing 20 different interventions. Effective interventions included: telephone reminders; questionnaire inclusion; monetary incentives; using an 'open' rather than placebo design; and making trial materials culturally sensitive. Conclusion Few trials have been undertaken to test interventions to improve trial recruitment. There is an urgent need for more RCTs of recruitment strategies.

Torgerson David J

2006-07-01

199

Can we rely on the best trial? A comparison of individual trials and systematic reviews  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background The ideal evidence to answer a question about the effectiveness of treatment is a systematic review. However, for many clinical questions a systematic review will not be available, or may not be up to date. One option could be to use the evidence from an individual trial to answer the question? Methods We assessed how often (a the estimated effect and (b the p-value in the most precise single trial in a meta-analysis agreed with the whole meta-analysis. For a random sample of 200 completed Cochrane Reviews (January, 2005 we identified a primary outcome and extracted: the number of trials, the statistical weight of the most precise trial, the estimate and confidence interval for both the highest weighted trial and the meta-analysis overall. We calculated the p-value for the most precise trial and meta-analysis. Results Of 200 reviews, only 132 provided a meta-analysis of 2 or more trials, with a further 35 effect estimates based on single trials. The average number of trials was 7.3, with the most precise trial contributing, on average, 51% of the statistical weight to the summary estimate from the whole meta-analysis. The estimates of effect from the most precise trial and the overall meta-analyses were highly correlated (rank correlation of 0.90. There was an 81% agreement in statistical conclusions. Results from the most precise trial were statistically significant in 60 of the 167 evaluable reviews, with 55 of the corresponding systematic reviews also being statistically significant. The five discrepant results were not strikingly different with respect to their estimates of effect, but showed considerable statistical heterogeneity between trials in these meta-analyses. However, among the 101 cases in which the most precise trial was not statistically significant, the corresponding meta-analyses yielded 31 statistically significant results. Conclusions Single most precise trials provided similar estimates of effects to those of the meta-analyses to which they contributed, and statistically significant results are generally in agreement. However, "negative" results were less reliable, as may be expected from single underpowered trials. For systematic reviewers we suggest that: (1 key trial(s in a review deserve greater attention (2 systematic reviewers should check agreement of the most precise trial and the meta analysis. For clinicians using trials we suggest that when a meta-analysis is not available, a focus on the most precise trial is reasonable provided it is adequately powered.

Shepperd Sasha

2010-03-01

200

[Internet use in clinical trials].  

Science.gov (United States)

Recruiting patients is a critical point of today's clinical research and, along the years, several solutions have been proposed, even if their efficacy seems to be doubtful. On the other hand, nowadays, Internet represents a great opportunity for improving clinical trial recruitments. Nevertheless, on-line recruitment services (e-recruitment) could ensure some advantages (such as facilitating interaction between supply and demand of clinical research, time and money savings/optimizations, data entry errors reduction), but also raise some issues (such as those related to sampling, information, consent, real identity of participants and risks for data breaches). The article debates on the difficulties to recruit patients for clinical research, in general, and e-recruitment particularly, discussing some ethical issues raised by internet enrolment. PMID:24589968

Refolo, P; Sacchini, D; Minacori, R; Spagnolo, A G

2014-01-01

 
 
 
 
201

Safety Monitoring in Clinical Trials  

Directory of Open Access Journals (Sweden)

Full Text Available Monitoring patient safety during clinical trials is a critical component throughout the drug development life-cycle. Pharmaceutical sponsors must work proactively and collaboratively with all stakeholders to ensure a systematic approach to safety monitoring. The regulatory landscape has evolved with increased requirements for risk management plans, risk evaluation and minimization strategies. As the industry transitions from passive to active safety surveillance activities, there will be greater demand for more comprehensive and innovative approaches that apply quantitative methods to accumulating data from all sources, ranging from the discovery and preclinical through clinical and post-approval stages. Statistical methods, especially those based on the Bayesian framework, are important tools to help provide objectivity and rigor to the safety monitoring process.

H. Amy Xia

2013-01-01

202

Controversy, Trials, and Crime--Oh My!  

Science.gov (United States)

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

Rott, Kim

2006-01-01

203

Cancer Clinical Trial Leadership and Management Program  

Science.gov (United States)

Posted: 06/23/2014 Posted: 06/23/2014 Cancer Clinical Trial Leadership and Management Program Quick Facts Free, short U.S.-based training program for cancer clinical trials nurse managers from the island of Ireland Helps facilitate cross-border and

204

Comments: Statistical Analysis for Multisite Trials  

Science.gov (United States)

In this article, the author shares his comments on statistical analysis for multisite trials, and focuses on the contribution of Stephen Raudenbush, Sean Reardon, and Takako Nomi to future research. Raudenbush, Reardon, and Nomi provide a major contribution to future research on variation in program impacts by showing how to use multisite trials

Bloom, Howard S.

2012-01-01

205

Innovative study design for paediatric clinical trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Purpose Despite representing a fundamental step towards the efficacious and safe utilisation of drugs in the paediatric population, the conduct of clinical trials in children poses several problems. Methodological issues and ethical concerns represent the major obstacles that have traditionally limited paediatric research. The randomised clinical trial, mainstay of clinical studies to assess the effects of any therapeutic intervention, shows some...

2011-01-01

206

Ethics of clinical trials in Nigeria.  

Science.gov (United States)

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

Okonta, Patrick I

2014-05-01

207

Uptake of breast cancer prevention and screening trials  

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Abstract Background: Uptake of cancer trials and in particular prevention trials has been disappointing globally. Methods: We have assessed uptake to three randomized chemotherapy breast cancer prevention trials and two dietary prevention trials in women at increased familial risk and compared it with uptake of screening trials across a range of risk categories. Results: Uptake of drug prevention trials remains low at 5.3-13.6%, but is significantly higher in the ...

2010-01-01

208

Data considerations in ischemic stroke trials.  

Science.gov (United States)

Data drive the analyses of any ischemic stroke trial, culminating in the main results and potential next steps. The distinct purpose of a given trial, advancing a novel treatment or examining routine clinical practice, determines the nature of essential data elements. Information gathering for an effective trial depends on ample data, adequate infrastructure, and properly planned statistical analyses. This review highlights the fact that successful future trials will require appropriate expertise that extends far beyond these basic considerations in order to move from identification of basic risk factors that are associated with outcomes to knowledge of pathophysiology and causation of outcomes. Efficient and productive data collection by local and central sites must be complemented by expert core lab adjudications. Source data archiving, including complete DICOM imaging datasets or biological specimens, are needed to maximize the potential for study interpretation and financial investment. Standard terminology, such as common data elements and definitions, enhance study comparisons. Screening logs attest to generalizability of a study. Real-time data transmission and core lab evaluation will be critical to guide adaptive trial design. Despite the overwhelming focus on the intervention in a particular treatment trial, individual pathophysiology must be considered. Understanding individual subject characteristics is a tenet of the coming era of precision stroke care, where the course of a given patient and eventual outcome is paramount. This will require a new approach to data collection in clinical trials. PMID:24641718

Liebeskind, David S; Feldmann, Edward

2014-05-01

209

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

1987-01-01

210

Genomic sequencing in clinical trials  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Human genome sequencing is the process by which the exact order of nucleic acid base pairs in the 24 human chromosomes is determined. Since the completion of the Human Genome Project in 2003, genomic sequencing is rapidly becoming a major part of our translational research efforts to understand and improve human health and disease. This article reviews the current and future directions of clinical research with respect to genomic sequencing, a technology that is just beginning to find its way into clinical trials both nationally and worldwide. We highlight the currently available types of genomic sequencing platforms, outline the advantages and disadvantages of each, and compare first- and next-generation techniques with respect to capabilities, quality, and cost. We describe the current geographical distributions and types of disease conditions in which these technologies are used, and how next-generation sequencing is strategically being incorporated into new and existing studies. Lastly, recent major breakthroughs and the ongoing challenges of using genomic sequencing in clinical research are discussed.

Mestan Karen K

2011-12-01

211

Single-trial normalization for event-related spectral decomposition reduces sensitivity to noisy trials  

Directory of Open Access Journals (Sweden)

These spectral methods do not have strong consensus for comparing pre and post-stimulus activity. When computing ERSP, pre-stimulus baseline removal is usually performed after averaging the spectral estimate of multiple trials. Correcting the baseline of each single-trial prior to averaging spectral estimates is an alternative baseline correction method. However, we show that this method leads to positively skewed post-stimulus ERSP values. We eventually present new single-trial based ERSP baseline correction methods that perform trial normalization or centering prior to applying classical baseline correction methods. We show that single-trial correction methods minimize the contribution of artifactual data trials with high-amplitude spectral estimates and are robust to outliers when performing statistical inference testing. We then characterize these methods in terms of their time-frequency responses and behavior when performing statistical inference testing compared to classical ERSP methods.

RomainGrandchamp

2011-09-01

212

Population activity changes during a trial-to-trial adaptation of bullfrog retinal ganglion cells.  

Science.gov (United States)

A 'trial-to-trial adaptation' of bullfrog retinal ganglion cells in response to a repetitive light stimulus was investigated in the present study. Using the multielectrode recording technique, we studied the trial-to-trial adaptive properties of ganglion cells and explored the activity of population neurons during this adaptation process. It was found that the ganglion cells adapted with different degrees: their firing rates were decreased in different extents from early-adaptation to late-adaptation stage, and this was accompanied by a decrease in cross-correlation strength. In addition, adaptation behavior was different for ON-response and OFF-response, which implied that the mechanism of the trial-to-trial adaptation might involve bipolar cells and/or their synapses with other neurons and the stronger adaptation in the ganglion cells' OFF-responses might reflect the requirement to avoid possible saturation in the OFF circuit. PMID:24848616

Ding, Wei; Xiao, Lei; Jing, Wei; Zhang, Pu-Ming; Liang, Pei-Ji

2014-07-01

213

New Psoriasis Drug Shows Promise in Trials  

Science.gov (United States)

... features on this page, please enable JavaScript. New Psoriasis Drug Shows Promise in Trials Secukinumab appears more ... Wednesday, July 9, 2014 Related MedlinePlus Pages Medicines Psoriasis WEDNESDAY, July 9, 2014 (HealthDay News) -- A new ...

214

Planning System Identification Trials of Waterway Tows.  

Science.gov (United States)

This report presents a plan for determining hydrodynamic coefficients of maneuvering simulation models for river tow/barge flotillas from data collected during free-running maneuvering trials of the full-scale river tows themselves. The plan includes spec...

T. L. Trankle

1980-01-01

215

Melanoma Drug Trials Show Significant Promise  

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... sharing features on this page, please enable JavaScript. Melanoma Drug Trials Show Significant Promise By targeting immune ... Monday, June 2, 2014 Related MedlinePlus Pages Medicines Melanoma MONDAY, June 2, 2014 (HealthDay News) -- A relatively ...

216

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

217

NIH Clinical Research Trials and You  

Science.gov (United States)

... Funding Information Search the NIH Guide Search the NIH Guide NIH Guide advanced search Quick Links RePORT ... Jobs at NIH NIH Director’s Blog NIH Home NIH Clinical Research Trials and You Home The Basics ...

218

PLCO Cancer Screening Trial Completes Recruitment  

Science.gov (United States)

The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial, sponsored by the National Cancer Institute (NCI), reached a significant milestone last month with the enrollment of its final participant

219

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

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Abstract Background and purpose Placebo response rates in clinical trials vary considerably and are observed frequently. For new drugs it can be difficult to prove effectiveness superior to placebo. It is unclear what contributes to improvement in the placebo groups. We wanted to clarify, what elements of clinical trials determine placebo variability. Methods We analysed a representative sample of 141 published long-term trials (randomized, double-blind, placebo...

2005-01-01

220

Consumers’ Trial Buying Process of Service Innovation.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Peltonen, Laura

2013-01-01

 
 
 
 
221

Quality of clinical trials: A moving target  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Bhatt, Arun

2011-01-01

222

Marketing and clinical trials: a case study  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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...

2007-01-01

223

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)

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.

Delaney Brendan

2010-04-01

224

On the Complexity of Trial and Error  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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...

Bei, Xiaohui; Chen, Ning; Zhang, Shengyu

2012-01-01

225

Multiple treatment comparisons in epilepsy monotherapy trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Background The choice of antiepileptic drug for an individual should be based upon the highest quality evidence regarding potential benefits and harms of the available treatments. Systematic reviews and meta-analysis of randomised controlled trials should be a major source of evidence supporting this decision making process. We summarise all available individual patient data evidence from randomised controlled trials that compared at least two out of eight antiepilep...

Tudur Smith Catrin; Marson Anthony G; Chadwick David W; Williamson1 Paula R

2007-01-01

226

Association of trial registration with the results and conclusions of published trials of new oncology drugs  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Registration of clinical trials has been introduced largely to reduce bias toward statistically significant results in the trial literature. Doubts remain about whether advance registration alone is an adequate measure to reduce selective publication, selective outcome reporting, and biased design. One of the first areas of medicine in which registration was widely adopted was oncology, although the bulk of registered oncology trials remain unpublished. The net influence of registration on the literature remains untested. This study compares the prevalence of favorable results and conclusions among published reports of registered and unregistered randomized controlled trials of new oncology drugs. Methods We conducted a cross-sectional study of published original research articles reporting clinical trials evaluating the efficacy of drugs newly approved for antimalignancy indications by the United States Food and Drug Administration (FDA from 2000 through 2005. Drugs receiving first-time approval for indications in oncology were identified using the FDA web site and Thomson Centerwatch. Relevant trial reports were identified using PubMed and the Cochrane Library. Evidence of advance trial registration was obtained by a search of clinicaltrials.gov, WHO, ISRCTN, NCI-PDQ trial databases and corporate trial registries, as well as articles themselves. Data on blinding, results for primary outcomes, and author conclusions were extracted independently by two coders. Univariate and multivariate logistic regression identified associations between favorable results and conclusions and independent variables including advance registration, study design characteristics, and industry sponsorship. Results Of 137 original research reports from 115 distinct randomized trials assessing 25 newly approved drugs for treating cancer, the 54 publications describing data from trials registered prior to publication were as likely to report statistically significant efficacy results and reach conclusions favoring the test drug (for results, OR = 1.77; 95% CI = 0.87 to 3.61 as reports of trials not registered in advance. In multivariate analysis, reports of prior registered trials were again as likely to favor the test drug (OR = 1.29; 95% CI = 0.54 to 3.08; large sample sizes and surrogate outcome measures were statistically significant predictors of favorable efficacy results at p Conclusions Trial registration alone, without a requirement for full reporting of research results, does not appear to reduce a bias toward results and conclusions favoring new drugs in the clinical trials literature. Our findings support the inclusion of full results reporting in trial registers, as well as protocols to allow assessment of whether results have been completely reported.

Bero Lisa

2009-12-01

227

Developing antitussives: the ideal clinical trial.  

Science.gov (United States)

Antitussive drugs are amongst the most widely used medications worldwide; however no new class of drugs have been introduced into the market for many years. Trials showing patient benefit are scarce and have been hampered by the lack of objective and validated outcome measures. Recent improvements in the assessment of cough will facilitate better trials and aid the development of antitussive drugs. When conducting a trial, patient selection is of paramount importance. Patients with unexplained chronic cough and sub-acute cough following upper respiratory tract infection are ideal because they represent an unmet clinical need and an untapped market for pharmaceutical companies. Patients with asthma and chronic obstructive pulmonary disease are less suitable since cough suppression is not always desirable and the findings of trials may not be generalisable to all patients with cough. Randomized, placebo-controlled, double-blind clinical trials are obviously the gold standard. The choice of placebo, whether inert or active, depends on the incidence and severity of drug side-effects. The primary outcome measure should be objective and cough monitors are the ideal tool. Subjective outcome measures should be used to assess symptoms and health related quality of life. Properly conducted clinical trials are an opportunity to evaluate the benefits of currently available therapies and aid advances in the antitussive drug market. PMID:19041729

Birring, Surinder S

2009-04-01

228

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

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Pyoderma gangrenosum (PG is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network’s STOP GAP Trial has been designed to address this lack of trial evidence. Methods The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4?mg/kg/day to prednisolone (0.75?mg/kg/day. A total of 140 participants are to be recruited over a period of 4?years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6?weeks is assessed blinded to treatment allocation (using digital images of the ulcers. Secondary outcomes include: (i time to healing; (ii global assessment of improvement; (iii PG inflammation assessment scale score; (iv self-reported pain; (v health-related quality of life; (vi time to recurrence; (vii treatment failures; (viii adverse reactions to study medications; and (ix cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG; measurable ulceration (that is, not pustular PG; and patients aged over 18?years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size, stratified by lesion size, and presence or absence of underlying systemic disease (for example, rheumatoid arthritis. Patients who require topical therapy are asked to enter a parallel observational study (case series. If topical therapy fails and systemic therapy is required, participants are then considered for inclusion in the randomised trial. Trial registration Current controlled trials: ISRCTN35898459. Eudract No.2008-008291-14.

Craig Fiona F

2012-04-01

229

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

1974-05-02

230

Internet trials: participant experiences and perspectives  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants’ attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. Objective To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. Methods All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. Results 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate. Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants’ comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience – a perceived benefit – and a lack connectedness and understanding – a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet; security, privacy and confidentiality issues; perceived benefits and disadvantages for researchers; technical aspects of using the Internet; and the impact of Internet data collection on information quality. Overall, more advantages were noted by participants, consistent with their preference for this mode of research over others. The majority of participants (69% would prefer to participate in Internet-based research compared to other modes of data collection in the future. Conclusion Participants in our survey would prefer to participate in Internet-based trials in the future compared to other ways of conducting trials. From the participants’ perspective, participating in Internet-based trials involves trade-offs. The central trade-off is between flexibility and convenience – a perceived benefit – and lack of connectedness and understanding – a perceived disadvantage. Strategies to maintain the convenience of the Internet while increasing opportunities for participants to feel supported, well-informed and well-understood would seem likely to increase the acceptability of Internet-based trials.

Mathieu Erin

2012-10-01

231

Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Retreatment Trial (CRRT). AIDS Clinical Trial Group (ACTG) protocol 228.  

Science.gov (United States)

This document contains the study data collection forms for the CMV Retinitis Retreatment Trial (CRRT). These forms also serve as dictionary to the data sets for the trial. The trial was a multicenter, unmasked clinical trial conducted by the Studies of th...

1995-01-01

232

Results of the gas carrier reliquefaction plant trial  

Digital Repository Infrastructure Vision for European Research (DRIVER)

In the paper results of the gas carrier reliquefaction plant trial are considered. Safe transportation of liquefied gases is explained. The construction of the ship on trial is described. Designed parameters of the reliquefaction plant are presented. Heat gain into cargo tanks is obtained. Volumetric capacity, cooling capacity, volumetric efficiency and power consumption of the compressors are determined. Results of the main engine trial, diesel generator trial, reliquefaction plant trial, an...

2007-01-01

233

To fail or not to fail : clinical trials in depression  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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.

Santen, Gijs Willem Eduard

2008-01-01

234

Centralized National Ethical Review of Clinical Trials in Croatia  

Science.gov (United States)

Aim To present the Croatian system of ethical review of clinical trials and assessment outcomes of the applications reviewed by the Croatian Central Ethics Committee. Methods Clinical trial applications reviewed by the Croatian Central Ethics Committee, which has the legal mandate to review clinical trials of medicinal products and medical devices, were retrospectively analyzed from May 2004 to the end of 2008 according to the number, research area, and type of opinion issued. Applications from 2008 were analyzed separately according to the study phase, participants (adult trials vs pediatric trials), and sponsor (commercial trials vs academic trials). Data were analyzed by descriptive statistics. Results Since its establishment in 2004, the Croatian Central Ethics Committee has reviewed 407 trials. The greatest number of clinical trials was in the field of oncology (n?=?69), mental and behavioral disorders (n?=?52), and endocrine, nutritional, and metabolic diseases (n?=?50). In the initial assessment of clinical trials, 60% applications received a conditionally positive opinion. In 28% of applications, the opinion had to be postponed because additional documentation or explanations were required. In 2008, the Croatian Central Ethics Committee reviewed 99 trials, most of which were phase III trials (n?=?57). Five clinical trials included pediatric population and 3 were academic clinical trials. Conclusion The model of centralized clinical trial review seems to be appropriate for the current number of clinical trials conducted in Croatia. The efficient and standardized review process of clinical trials by the Central Ethics Committee may positively affect the increasing number of clinical trials conducted in Croatia. Future development includes the transparency of the clinical trials through a publically available database and establishing the basis for conducting academic clinical trials.

Vitezic, Dinko; Lovrek, Maja; Tomic, Sinisa

2009-01-01

235

Randomised clinical trials of choroidal melanoma treatment.  

Directory of Open Access Journals (Sweden)

Full Text Available Purpose: To illustrate an approach to evidence-based medical practice by reporting the Collaborative Ocular Melanoma Study (COMS randomised clinical trials and cohort studies of choroidal melanoma. Methods: COMS randomised clinical trials of Iodine-125 (I-125 brachytherapy, adjunctive cohort study of visual acuity in eyes treated with brachytherapy and adjunctive natural history study. COMS randomised clinical trial of pre-enucleation radiation. Results: The COMS I-125 brachytherapy trial (N = 1,317 patients of medium-sized choroidal melanoma showed 5-year all-cause mortality of 18% [95% Confidence Interval (CI, 16-20%] and no statistically significant difference in mortality following 1-125 brachytherapy or enucleation. Adjunctive cohort natural history study (N-42 patients of patients eligible for the I-125 brachytherapy trial who deferred treatment or had no melanoma treatment had a 5-year all-cause mortality of 30% (95% CI, 18-47%. The COMS pre-enucleation radiation trial (N = 1,003 patients of large-sized choroidal melanoma showed 5-year all-cause mortality of 40% (95% CI, 37-44%. Conclusions: Evidence derived from randomised clinical trials and cohort studies shows the need for longterm (? 5 years follow-up to determine the efficacy of treatment for choroidal melanoma by any modality. The rather similar 5-year mortality for treated and untreated medium melanoma patients suggests that metastatic dissemination may occur at an early stage of choroidal melanoma. To increase longterm survival, ocular treatment of choroidal melanoma must strive for diagnosis and treatment of melanoma at an early stage when metastasis is less likely and be combined with measures to detect and treat micrometastasis

Straatsma Bradley

2003-01-01

236

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

Science.gov (United States)

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

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

2009-01-01

237

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

Science.gov (United States)

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

238

New trial proposed for when drugs fail.  

Science.gov (United States)

On May 11, 1995, community AIDS representatives met with members of the Clinical Trials subcommittee of the Inter-Company Collaboration for AIDS Drug Development (ICC) to discuss several proposals. David Barry, M.D., chairman of the Clinical Trials subcommittee, suggested an innovative trial design that would include studies of combinations of drugs (often new ones) in patients who already have resistant virus (experienced patients). By studying experienced patients, it may be possible to learn more than what would apply to just naive patients. It would also provide a surrogate marker for duration of benefit. Trials would use a small number of patients (usually under thirty) who would receive different drug combination regimens. CD4 count and viral load would be followed throughout the study. Those who do not fair well would immediately move to a different regimen. Three other proposals were discussed at the meeting. Bill Bahlman of the Treatment and Data Committee of ACT UP/New York, proposed small, uncontrolled screening trials for initial tests of new combinations. Jules Levin of the New York University Community Advisory Board, proposed comparing MK-639 (the Merck protease inhibitor) alone, versus saquinavir (the Hoffmann-La Roche protease inhibitor) alone, versus the two together. This would be a randomized, pilot study with about 90 patients, lasting 24 weeks. It would look for toxicity, changes in viral load and in CD4 count, and resistance patterns. The third proposal suggested computerizing medical records, thereby making future studies safer and faster. PMID:11362467

James, J S

1995-05-19

239

Randomized trials, statistics, and clinical inference.  

Science.gov (United States)

The completion and proper assessment of prospective, randomized controlled trials is essential for best medical practice. However, even though randomized trials are generally considered the pinnacle of evidence-based medicine, they are not infrequently poorly designed, implemented with inadequate quality control, and/or are subject to inappropriate interpretation or generalization, resulting in suboptimal clinical care and/or future investigative directions. The present report describes the most common and egregious misrepresentations from randomized trials, many of which may be attributed to the fallacies that arise from underpowered studies, resulting in overly optimistic or unwarranted conclusions. Caution is necessary when assessing composite outcomes, secondary end points, subgroup analyses, and the results of meta-analysis and meta-regression. Sponsors and investigators must accept responsibility for optimizing the design and execution of clinical trials, and practitioners, guidelines committees, editors, and regulators must critically interpret the data and literature arising from such studies. It is hoped that the principles embodied in the present commentary will spur improved design of future randomized trials and thoughtful critical appraisal by health care providers. PMID:20117455

Stone, Gregg W; Pocock, Stuart J

2010-02-01

240

A systematic review and meta-analysis of trials of treatment of depression from India  

Science.gov (United States)

Background: Antidepressants hold the center stage in the treatment of depression in current clinical practice. However, it is also well-known that the treatment response and dosage requirement are influenced by ethnic variations. Although many efficacy studies have evaluated the efficacy of antidepressants, there is lack of systematic reviews and meta-analysis of the existing literature from India. Objective: To systematically review the efficacy of treatment of depression in the Indian context. Materials and Methods: We searched PubMed, Psychinfo, Medknow and Google scholar to identify studies published in peer-reviewed English language journals. All controlled trials from India evaluating the clinical efficacy of antidepressants, electroconvulsive therapy (ECT), and repetitive transcranial magnetic stimulation (rTMS) for management of depression were evaluated. Data were extracted using standard procedures and risk of bias was evaluated. Effect sizes were computed for the individual studies. Results: Effect sizes were computed from 35 clinical trials. Overall, medications were superior to placebo for treatment of depression (mean effect size (ES) of 0.87, confidence intervals (CI of 0.71-1.02). The effect was greatest for tricyclic antidepressants (ES of 1.00, CI of 0.80-1.21) followed by monoamine oxidase inhibitors (ES 0.54, CI of 0.40-0.67). ECT was superior to antidepressants (ES 0.32, CI of ? 0.21 to 0.86) and active rTMS was found to be superior to sham rTMS with mean effect size of 0.74 (CI 0.39-1.08). Risk of bias was found to be considerable. However, the review literature suggests that most of the studies have not been powered adequately and have been limited to small sample sizes. Conclusions: Although there is some data from India with respect to efficacy of antidepressants, most of the trials have been of shorter duration have been inadequately powered. The available data support the superiority of antidepressants over placebo and that of ECT over antidepressants.

Sarkar, Siddharth; Grover, Sandeep

2014-01-01

 
 
 
 
241

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)

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

Kuznetsov, D A; Zavijalov, N V

1987-01-01

242

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

OBJECTIVE: the association of sternal and vertebral fractures has previously been described in the literature. These lesions are frequently overlooked at the initial evaluation. The purpose of this study was to review and discuss the diagnostic methods used to diagnose these lesions and to highlight the importance of early recognition of these fractures. METHODS: we performed a retrospective analysis of six patients who suffered sternal and concomitant vertebral fractures. Clinical charts and...

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

2010-01-01

243

New uses for a well-known fruit. Biogas production from residues of olive and olive oil production; Alte Frucht bekommt neue Bedeutung. Aus Reststoffen der Oliven- und Olivenoelproduktion kann Biogas erzeugt werden  

Energy Technology Data Exchange (ETDEWEB)

Olive pulp and other residues of olive oil production can be used for biogas production. The contribution goes into detail about the biogas production process and the difficulties that may arise. (orig.)

Bartel, Regina

2009-09-15

244

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

Directory of Open Access Journals (Sweden)

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

Waldén Markus

2009-06-01

245

Update on clinical trials in Dysphagia.  

Science.gov (United States)

Randomized clinical trials (RCTs) are often known as the gold standard in treatment efficacy studies. This article defines the characteristics of RCTs and the factors that investigators must consider in designing clinical trials in dysphagia. Design issues unique to behavioral treatments often used in dysphagia are discussed. Ongoing RCTs in dysphagia are described including studies of (1) the effectiveness of the Shaker exercise versus standardized treatment in patients with severe dysphagia resulting from stroke or treatment for head and neck cancer who have been nonoral for at least three months; (2) the comparative effects of nectar- and honey-thickened liquids versus chin tuck posture and in patients with dementia or Parkinson's disease with or without dementia who aspirate on thin liquids; and (3) the comparative effects of muscle exercise versus sensory postural therapy for dysphagia resulting from treatment for head and neck cancer. Issues in generalizing from the results of clinical trials are also described. PMID:16685468

Logemann, Jeri A

2006-04-01

246

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.)

2010-05-01

247

Current Vaccine Trials in Glioblastoma: A Review  

Science.gov (United States)

Glioblastoma (GBM) is the most common primary brain tumor, and despite aggressive therapy with surgery, radiation, and chemotherapy, average survival remains at about 1.5 years. The highly infiltrative and invasive nature of GBM requires that alternative treatments for this disease be widespread and targeted to tumor cells. Immunotherapy in the form of tumor vaccines has the potential to meet this need. Vaccines against GBM hold the promise of triggering specific and systemic antitumor immune responses that may be the key to eradicating this unrelenting cancer. In this review, we will discuss past and present clinical trials of various GBM vaccines and their potential impact on the future care of GBM patients. There have been many promising phase I and phase II GBM vaccine studies that have led to ongoing and upcoming phase III trials. If the results of these randomized trials show a survival benefit, immunotherapy will become a standard part of the treatment of this devastating disease.

Xu, Linda W.; Chow, Kevin K. H.

2014-01-01

248

Advances in cardiology: clinical trial update.  

Science.gov (United States)

Multiple key cardiology trials have been presented or published over recent months, several with the potential to change clinical practice. In this article, we summarize and place in clinical context new trial findings regarding anticoagulation in the cardiac catheterization laboratory (enoxaparin, fondaparinux and unfractionated heparin), the implications of genetic polymorphisms and functional testing for antiplatelet therapy (clopidogrel and ticagrelor), new oral anticoagulants for use in atrial fibrillation (apixiban and rivaroxaban), optimal pacing strategies and pharmacological agents in heart failure (ivabradine, eplerenone, cardiac resynchronization therapy, telemonitoring and intracoronary bone marrow stem cell infusion). Clinical trials in percutaneous structural intervention (transcatheter aortic valve implantation, MONARC™ mitral annular implant, STARFlex(®) patent foramen ovale device) and advanced percutaneous coronary intervention (everolimus-eluting stents, biodegradable polymer/polymer-free technologies and contemporary use of intravascular ultrasound) are also discussed. PMID:21627472

Howe, Andrew J; Shand, James A; Menown, Ian B A

2011-05-01

249

Random error in clinical trials (II  

Directory of Open Access Journals (Sweden)

Full Text Available Random error in clinical trials can induce several types of flaws. One of them is to show a possible association that does not really exist when too many variables are linked (Type I error. Another type of failure is the opposite: the correlation does actually exist, but the study does not account for it because of insufficient sample size (Type II error. Another common mistake occurs in the unit of analysis in cluster randomized trials, when analyzing data from individual subjects as if they were independent.

Miguel Araujo Alonso

2012-07-01

250

Thymus pathology observed in the MGTX trial.  

Science.gov (United States)

The MGTX trial is the first prospective, randomized clinical trial that aims to evaluate the impact of extended transsternal thymectomy on myasthenic symptoms, prednisone requirements, and quality of life in patients with nonthymomatous, anti-acetylcholine receptor autoantibody-positive myasthenia gravis (MG). Here, we give an overview of the rationale of thymectomy and the standardized macroscopic and histopathological work-up of thymectomy specimens as fixed in MGTX standard operating procedures, including the grading of thymic lymphofollicular hyperplasia and the morphometric strategy to assess thymic involution. PMID:23278583

Marx, Alexander; Pfister, Frederik; Schalke, Berthold; Nix, Wilfred; Ströbel, Philipp

2012-12-01

251

Clinical Trials in Male Hormonal Contraception  

Directory of Open Access Journals (Sweden)

Full Text Available Research has established the principle of hormonal male contraception based on suppression of gonadotropins and spermatogenesis. All hormonal male contraceptives use testosterone, but only in East Asian men can testosterone alone suppress spermatogenesis to a level compatible with contraceptive protection. In Caucasians, additional agents are required of which progestins are favored. Clinical trials concentrate on testosterone combined with norethisterone, desogestrel, etonogestrel or depot-medroxyprogesterone acetate. The first randomized, placebo-controlled clinical trial performed by the pharmaceutical industry demonstrated the effectiveness of a combination of testosterone undecanoate and etonogestrel in suppressing spermatogenesis in volunteers.

Nieschlag E

2011-01-01

252

Photovoltaic domestic field trial. Third annual report  

Energy Technology Data Exchange (ETDEWEB)

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.

NONE

2005-07-01

253

Clinical Trials : Growing Opportunities for India  

Digital Repository Infrastructure Vision for European Research (DRIVER)

The US$65-billion (in 2005), global R&D pie is expected to grow to US$l00-billion by 2010. If India secures even a small share of this, it could grow 2-billion business.Thus, pharmaceutical R&D, whether outsourcing or indigenous, is likely to emerge as a multi­billion dollar industry, including contract research and manufacturing, clinical trials, etc. Indian clinical trials market in 2006 was US$ 140million and is growing at a CAGR of 40% for the last 3 years. India is fast emerging as a fa...

2008-01-01

254

Future of Clinical Trials in Nepal  

Directory of Open Access Journals (Sweden)

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

Brijesh Sathian

2011-07-01

255

Central Retinal Enrichment Supplementation Trials (CREST): Design and Methodology of the CREST Randomized Controlled Trials  

Science.gov (United States)

Purpose The Central Retinal Enrichment Supplementation Trials (CREST) aim to investigate the potential impact of macular pigment (MP) enrichment, following supplementation with a formulation containing 10?mg lutein (L), 2?mg zeaxanthin (Z) and 10?mg meso-zeaxanthin (MZ), on visual function in normal subjects (Trial 1) and in subjects with early age-related macular degeneration (AMD; Trial 2). Methods CREST is a single center, double-blind, randomized clinical trial. Trial 1 (12-month follow-up) subjects are randomly assigned to a formulation containing 10?mg?L, 10?mg MZ and 2?mg Z (n?=?60) or placebo (n?=?60). Trial 2 (24-month follow-up) subjects are randomly assigned to a formulation containing 10?mg?L, 10?mg MZ, 2?mg Z plus 500?mg vitamin C, 400?IU vitamin E, 25?mg zinc and 2?mg copper (Intervention A; n?=?75) or 10?mg?L and 2?mg Z plus 500?mg vitamin C, 400?IU vitamin E, 25?mg zinc and 2?mg copper (Intervention B; n?=?75). Contrast sensitivity (CS) at 6 cycles per degree represents the primary outcome measure in each trial. Secondary outcomes include: CS at other spatial frequencies, MP, best-corrected visual acuity, glare disability, photostress recovery, light scatter, cognitive function, foveal architecture, serum carotenoid concentrations, and subjective visual function. For Trial 2, AMD morphology, reading speed and reading acuity are also being recorded. Conclusions CREST is the first study to investigate the impact of supplementation with all three macular carotenoids in the context of a large, double-blind, randomized clinical trial.

Beatty, Stephen; Stack, Jim; Dennison, Jessica; O'Regan, Sarah; Meagher, Katherine A.; Peto, Tunde; Nolan, John

2014-01-01

256

EEG activity reveals a trial-by-trial representation of the correctness of decisions  

Directory of Open Access Journals (Sweden)

Full Text Available Performance monitoring is an executive function, which we depend on for detecting and evaluating the consequences of our behavior. Although event related potentials (ERPs have revealed the existence of differences after correct and incorrect decisions, it is not known whether there is a trial-by-trial representation of the accuracy of the decision. We recorded the electroencephalographic activity (EEG while participants performed a perceptual discrimination task, with two levels of difficulty, in which they received immediate feedback. Receiver Operating Characteristic (ROC analyses were used to reveal two components that convey trial-by-trial representations of the correctness of the decisions. Firstly, the performance monitoring-related negativity (PM-N, a negative deflection whose amplitude is higher (more negative after incorrect trials. Secondly, the performance monitoring-related positivity (PM-P, a positive deflection whose amplitude is higher after incorrect trials. During the time periods corresponding to these components, trials can be accurately categorized as correct or incorrect by looking at the EEG activity; this categorization is more accurate when based on the PM-P. We further show that the difficulty of the discrimination task has a different effect on each component: after easy trials the latency of the PM-N is shorter and the amplitude of the PM-P is higher than after difficult trials. Consistent with previous interpretations of performance-related ERPs, these results suggest a functional differentiation between these components. The PM-N could be related to an automatic error detection system, responsible for fast behavioral corrections of ongoing actions, while the PM-P could reflect the difference between expected and actual outcomes and be related to long-term changes in the decision process.

JoseLPardo-Vazquez

2014-03-01

257

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

Science.gov (United States)

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

2014-01-01

258

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

Directory of Open Access Journals (Sweden)

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

Gerritsen Annette

2011-03-01

259

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

Directory of Open Access Journals (Sweden)

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.

Veerus Piret

2005-04-01

260

Cytomegalovirus vaccine: phase II clinical trial results.  

Science.gov (United States)

Cytomegalovirus (CMV) is one of the most significant viral pathogens during pregnancy and in immunocompromised patients. Antiviral prophylactic strategies are limited by toxicities, drug-drug interactions and development of antiviral resistance. A safe and protective vaccine against CMV is highly desirable in view of the potential positive impact on CMV-associated morbidity and mortality as well as healthcare costs. Unfortunately, this demand could not be met in the past four decades although development of a CMV vaccine has been ranked at the highest priority by the US Institute of Medicine. Multiple different vaccine candidates have been developed and evaluated in phase I clinical trials and few succeeded to phase II trials. Nevertheless, two different vaccines showed recently promising results in trials that studied healthy adults and immunocompromised solid-organ and bone-marrow transplant recipients, respectively. The gB/MF59 vaccine exhibited a vaccine efficacy of 50% in healthy, postpartum females. In transplant patients, gB/MF59 and the DNA vaccine TransVax both limited the periods of viraemia and consequently the need for antiviral treatment. The success of these trials is encouraging and will probably give new impetus to the development of an effective CMV vaccine. Sterilizing immunity may not be attainable in the near future and may not be necessary for a CMV vaccine to have a significant impact on health care as discussed in the present review. PMID:24283990

Rieder, F; Steininger, C

2014-05-01

 
 
 
 
261

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)

2007-03-01

262

Part B: Celladon Corporation: GM Trials  

Dec 23, 2012 ... For the first trial: “A Phase 2b, Double-Blind, Placebo-Controlled, Multinational,. \\Multicenter, Randomized Study Evaluating the Safety and Efficacy of \\Intracoronary .... A new treatment option for this patient population which reduced \\... indication for HF based on a reduction in the frequency and/or delaying ...

263

Unit: Petroleum, Inspection Pack, National Trial Print.  

Science.gov (United States)

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

Australian Science Education Project, Toorak, Victoria.

264

Trial access to Cambridge University Press ebooks  

CERN Multimedia

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.

CERN Library

2011-01-01

265

Synthesizing Results from the Trial State Assessment.  

Science.gov (United States)

Uses data from the Trial State Assessment of the National Assessment of Educational Progress to describe and illustrate a two-stage statistical model for investigating state-to-state variation in mathematics achievement. Results reveal considerable state-to-state heterogeneity in mathematics proficiency, but most heterogeneity is explainable on…

Raudenbush, Stephen W.; Fotiu, Randall P.; Cheong, Yuk Fai

1999-01-01

266

Trial & Error to Collusion - The Discrete Case  

Digital Repository Infrastructure Vision for European Research (DRIVER)

In this note we study a very simple trial & error learning process in the context of a Cournot oligopoly. Without any knowledge of the payoff functions players increase, respectively decrease, their quantity by one unit as long as this leads to higher profits. We show that despite the absence of any coordination or punishing device this process converges to a collusive outcome.

Huck, Steffen; Normann, Hans-theo; Oechssler, Jo?rg

2000-01-01

267

How a Cancer Trial Ended in Betrayal  

Science.gov (United States)

In this case study, students learn about the complexities and issues associated with clinical trials. After reading a newspaper story about a fraudulently conducted clinical trial involving a treatment for skin cancer, students simulate their own small-scale “clinical trial” in class. The simulation involves a secret breaching of a blind test and manipulation of data to favor a positive effect for a particular proprietary drug. As part of the simulation, students examine “before” and "after” photographs of skin lesions from “patients.”  Developed for first- or second-year college students, the case focuses on the scientific method, with special attention to the issues of objectivity and ethics in scientific research. The case study can be adapted to emphasize other topics, such as the pathophysiology and treatment of cancer.  It can also be tailored to specific student populations, such as health professional students , by including in the case more information on the drug approval process (pre-clinical and clinical trials), T-cell lymphoma, and the effects of the immunosuppresive drug, BCX-34.

Chen-Izu, Ye

2002-01-01

268

Pipeline Decommissioning Trial AWE Berkshire UK - 13619  

Energy Technology Data Exchange (ETDEWEB)

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)

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

2013-07-01

269

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)

2013-02-24

270

ADEPT - Abnormal Doppler Enteral Prescription Trial  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Pregnancies complicated by abnormal umbilical artery Doppler blood flow patterns often result in the baby being born both preterm and growth-restricted. These babies are at high risk of milk intolerance and necrotising enterocolitis, as well as post-natal growth failure, and there is no clinical consensus about how best to feed them. Policies of both early milk feeding and late milk feeding are widely used. This randomised controlled trial aims to determine whether a policy of early initiation of milk feeds is beneficial compared with late initiation. Optimising neonatal feeding for this group of babies may have long-term health implications and if either of these policies is shown to be beneficial it can be immediately adopted into clinical practice. Methods and Design Babies with gestational age below 35 weeks, and with birth weight below 10th centile for gestational age, will be randomly allocated to an "early" or "late" enteral feeding regimen, commencing milk feeds on day 2 and day 6 after birth, respectively. Feeds will be gradually increased over 9-13 days (depending on gestational age using a schedule derived from those used in hospitals in the Eastern and South Western Regions of England, based on surveys of feeding practice. Primary outcome measures are time to establish full enteral feeding and necrotising enterocolitis; secondary outcomes include sepsis and growth. The target sample size is 400 babies. This sample size is large enough to detect a clinically meaningful difference of 3 days in time to establish full enteral feeds between the two feeding policies, with 90% power and a 5% 2-sided significance level. Initial recruitment period was 24 months, subsequently extended to 38 months. Discussion There is limited evidence from randomised controlled trials on which to base decisions regarding feeding policy in high risk preterm infants. This multicentre trial will help to guide clinical practice and may also provide pointers for future research. Trial registration Current Controlled Trials ISRCTN: 87351483

McCormick Kenny

2009-10-01

271

Trial-to-trial, uncertainty-based adjustment of decision boundaries in visual categorization.  

Science.gov (United States)

Categorization is a cornerstone of perception and cognition. Computationally, categorization amounts to applying decision boundaries in the space of stimulus features. We designed a visual categorization task in which optimal performance requires observers to incorporate trial-to-trial knowledge of the level of sensory uncertainty when setting their decision boundaries. We found that humans and monkeys did adjust their decision boundaries from trial to trial as the level of sensory noise varied, with some subjects performing near optimally. We constructed a neural network that implements uncertainty-based, near-optimal adjustment of decision boundaries. Divisive normalization emerges automatically as a key neural operation in this network. Our results offer an integrated computational and mechanistic framework for categorization under uncertainty. PMID:24272938

Qamar, Ahmad T; Cotton, R James; George, Ryan G; Beck, Jeffrey M; Prezhdo, Eugenia; Laudano, Allison; Tolias, Andreas S; Ma, Wei Ji

2013-12-10

272

Most Breast Cancer Screening Trials Have a Flawed Design  

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In the present article, we discuss that why most breast cancer screening trials have a flawed origin. We suggest some solutions to correct these flaws so that more valid and reliable screening trials can be conducted in the future.

Gurnani, Nishant; Srivastava, Anurag

2011-01-01

273

EU Parliament, ministers agree to more clinical trial transparency in clinical trials | EurActiv  

... Those accusations were epitomised in a book, Bad Pharma by Ben Goldacre, a research fellow of epidemiology at the London School of ... More on this topic News Pharma industry tries to mobilise patient groups in clinical trials battleHealth NGO pushes for more transparency in clinical ...trialsHealth experts critical of pharma industry's new transparency rulesInterview Pharma chief: Governments must stop thinking short-term More in this section Ukrainian leadership vote ...

274

Trial effects in single-trial ERP components and autonomic responses at very long ISIs.  

Science.gov (United States)

Single-trial data from autonomic and ERP measures were used to capture the rapidly decreasing initial responses characteristic of the orienting reflex (OR) to repeated stimuli. Stimulus-response patterns were compared to determine central analogues of autonomic indices of processes leading to the OR, and the OR itself. Participants were presented with 12 indifferent tones in an auditory dishabituation paradigm. Temporal principal component analysis (PCA) decomposed EOG-corrected ERP data for 16 subjects. Response patterns of ERPs, cardiac, and respiratory responses were compared to the phasic skin conductance response (SCR). SCR decremented over trials, recovered on the change trial, and dishabituated to the representation of the standard, meeting the formal definition of habituation required of the OR. The evoked cardiac response showed no trial effects. Respiratory pause (RP) decreased linearly over trials, recovering marginally on the change trial. Nine identifiable ERP components were extracted: P1, N1-3, N1-1, processing negativity (PN), P2, P3a, P3b, a novelty-sensitive P3 component (labelled HabP3), and the slow wave (SW). P3b and SW showed decrement over trials, but with no recovery, HabP3 showed decrement and increased response on the change trial, while the P1, N1 subcomponents, P2 and P3a were insensitive to novelty. Stimulus-response patterns of the RP and HabP3 suggest sensitivity to novelty processing, while the P1, N1-3, N-1, PN, P2, P3a and cardiac deceleration appear to mark processing prior to novelty, such as stimulus transient detection (cardiac deceleration) and/or intensity processing. This study supports predictions of preliminary process theory, demonstrating fractionation of 3 autonomic and 9 ERP components to novelty, and disconfirming the unitary nature of the OR. PMID:24681245

MacDonald, Brett; Barry, Robert J

2014-06-01

275

Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials  

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There is mounting scientific evidence pointing to genetic or physiologic distinctions between genders and among racial and ethnic groups that influence disease risk and severity and response to treatment. The diverse enrollment of subjects engaged in clinical trials research is, thus, critical to developing safer and more effective drugs and medical devices. However, in the United States, there are striking disparities in clinical trial participation. To address this problem, the Food and Dru...

Coakley, Meghan; Fadiran, Emmanuel Olutayo; Parrish, L. Jo; Griffith, Rachel A.; Weiss, Eleanor; Carter, Christine

2012-01-01

276

The CRASH trial: the first large-scale, randomised, controlled trial in head injury  

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The global epidemic of head injuries is just beginning. Many are caused by road traffic crashes. It is estimated that, by 2020, road traffic crashes will have moved from its present position of ninth to third in the world disease burden ranking, as measured in disability adjusted life years. In developing countries, it will have moved to second. The Corticosteroid Randomisation After Significant Head Injury (CRASH) trial is a large-scale, randomised, controlled trial, among adults with head i...

Roberts, Ian

2001-01-01

277

Trial-by-trial analysis of intermanual transfer during visuomotor adaptation  

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Studies of intermanual transfer have been used to probe representations formed during skill acquisition. We employ a new method that provides a continuous assay of intermanual transfer, intermixing right- and left-hand trials while limiting visual feedback to right-hand movements. We manipulated the degree of awareness of the visuomotor rotation, introducing a 22.5° perturbation in either an abrupt single step or gradually in ?1° increments every 10 trials. Intermanual transfer was observ...

2011-01-01

278

ICD-10 FIELD TRIALS IN INDIA - A REPORT  

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The draft of the tenth revision of the International Classification Of Diseases, Chapter V (ICD-10) was subjected to extensive field trials throughout the world. In India, Nine Field Trial Centres (PTCs) conducted the field trials. The results showed that the ICD-10 was quite adequate in its face-validity, reliability, applicability and ease of use. A brief account of the field trials and the result are reported.

1992-01-01

279

Inadequate description of educational interventions in ongoing randomized controlled trials  

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Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs) o...

Pino Cécile; Boutron Isabelle; Ravaud Philippe

2012-01-01

280

Good clinical practice: International quality standard for clinical trials  

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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 subj...

Radulovi? Siniša S.

2003-01-01

 
 
 
 
281

The problem of truth in war crimes trials  

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The author discusses the relationship between the truth and criminal trial in general, with a special focus on war crimes trials and their consequences for the fragile processes of consolidation of violated collective identities in post-conflict states. The authors challenge the idea that a criminal trial is a search for the truth, and present a philosophical argument to the effect that the trial is in fact an event conforming to the model of what the author calls “quasi-epistemologic...

Fati? Aleksandar; Bulatovi? Aleksandra

2012-01-01

282

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

Directory of Open Access Journals (Sweden)

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

Walach Harald

2005-08-01

283

The Beta Agonist Lung Injury TrIal (BALTI - prevention trial protocol  

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Full Text Available Abstract Background Acute lung injury complicates approximately 25-30% of subjects undergoing oesophagectomy. Experimental studies suggest that treatment with beta agonists may prevent the development of acute lung injury by decreasing inflammatory cell infiltration, activation and inflammatory cytokine release, enhancing basal alveolar fluid clearance and improving alveolar capillary barrier function. Methods/Design The Beta Agonist Lung Injury TrIal (prevention is a multi-centre, randomised, double blind, placebo-controlled trial. The aim of the trial is to determine in patients undergoing elective transthoracic oesphagectomy, if treatment with inhaled salmeterol 100 mcg twice daily started at induction of anaesthesia and continued for 72 hours thereafter compared to placebo affect the incidence of early acute lung injury and other clinical, resource and patient focused outcomes. The primary outcome will be the development of acute lung injury within 72 hours of oesophagectomy. The trial secondary outcomes are the development of acute lung injury during the first 28 days post operatively; PaO2: FiO2 ratio; the number of ventilator and organ failure free days, 28 and 90 day survival; health related quality of life and resource utilisation. The study aims to recruit 360 patients from 10 UK centres. Trial registration number Current Controlled Trials ISRCTN47481946

Gates Simon

2011-03-01

284

Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial  

Science.gov (United States)

The Etiology and Early Marker Studies (EEMS) is an ongoing component of the PLCO Trial. By collecting biologic materials and risk factor information from trial participants before the diagnosis of disease, PLCO EEMS adds substantial value to the trial, providing a resource for cancer research, focused, in particular, on cancer etiology and early markers.

285

Globally optimal trial design for local decision making.  

Science.gov (United States)

Value of information methods allows decision makers to identify efficient trial design following a principle of maximizing the expected value to decision makers of information from potential trial designs relative to their expected cost. However, in health technology assessment (HTA) the restrictive assumption has been made that, prospectively, there is only expected value of sample information from research commissioned within jurisdiction. This paper extends the framework for optimal trial design and decision making within jurisdiction to allow for optimal trial design across jurisdictions. This is illustrated in identifying an optimal trial design for decision making across the US, the UK and Australia for early versus late external cephalic version for pregnant women presenting in the breech position. The expected net gain from locally optimal trial designs of US$0.72M is shown to increase to US$1.14M with a globally optimal trial design. In general, the proposed method of globally optimal trial design improves on optimal trial design within jurisdictions by: (i) reflecting the global value of non-rival information; (ii) allowing optimal allocation of trial sample across jurisdictions; (iii) avoiding market failure associated with free-rider effects, sub-optimal spreading of fixed costs and heterogeneity of trial information with multiple trials. PMID:18435429

Eckermann, Simon; Willan, Andrew R

2009-02-01

286

Fair Press or Trial Prejudice?: Perceptions of Criminal Defendants.  

Science.gov (United States)

Examines criminal defendants' perceptions of the free press/fair trial issue with respect to perceived influences of media coverage on the disposition of criminal cases and the outcome of criminal trials. Concludes that the press' influence on trials is generally perceived as minimal and fair. (MM)

Sherard, Regina Ganelle

1987-01-01

287

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.)

1996-03-01

288

[Causes of death in surgically treated ulcer patients. Results from the Aarhus County Vagotomy Trial].  

Science.gov (United States)

It is a well-known observation that patients submitted to operation for benign duodenal or gastric ulceration have reduced long-term survival as compared with the basic population. This excessive mortality may attributed to association between peptic ulceration and other conditions, particularly pulmonary disease, cirrhosis of the liver and suicide. In order to investigate whether there is a difference in the pattern of causes of death in patients treated with classical gastric resection and patients treated the vagotomy methods employed in recent years, an analysis of the causes of death in 169 patients was undertaken. During the years 1972-1977 these patients had been treated with selective gastric vagotomy with drainage, selective gastric vagotomy with antrectomy, parietal cell vagotomy with or without drainage for duodenal ulceration, pyloric ulceration, prepyloric ulceration or combined ulceration. This is termed the Aarhus County Vagotomy Trial. Comparison with the basic population reveals statistically significant excessive mortality from gastro-intestinal disease including the subgroups benign ulcer disease and cirrhosis of the liver and accidents including the subgroup of suicide. The mortality from malignant conditions did not differ significantly from the control group with the exception of significantly increased incidence of cancer of the stomach. The death ratio was increased for cancer in the lungs and pancreas but this was not statistically significant. These results are in agreement with reviews based on resection materials apart from the observation that a significant excess mortality from cancer of the stomach was demonstrated in this patient group in the present investigation which is not a constant finding in previous investigations. In addition, no increased incidence of benign pulmonary disease could be demonstrated. PMID:2603235

Ditlevsen, S

1989-12-01

289

Oropharyngeal dysphagia, free water protocol and quality of life: an update from a prospective clinical trial.  

Science.gov (United States)

Oropharyngeal dysphagia, typically associated with older adults, represents a spectrum of swallowing disorders with potentially serious complications and a negative impact on quality of life. A major complication of dysphagia is caused by aspiration, predominantly of thin liquids, which may cause aspiration pneumonia. Given that thin liquids are typically aspirated, the conventional therapy involves altering the diet to one consisting of modified solid consistencies and thickened fluids. While it is well known that this approach is appropriate for aspiration, it does represent difficulties with compliancy and quality of life. We have undertaken a relatively large scale clinical trial to investigate the relationships between the effects of free access to water and the development of aspiration, aspects of hydration and issues related to quality in people with dysphagia. Along with clinical observations and findings from others we have previously stratified people with dysphagia, namely those that are immobile or who have low mobility and severe degenerative neurological dysfunction, at highest risk of developing aspiration pneumonia following intake of water. In the present study, we have extended our previous clinical results. Our findings indicate that following purposeful selection of people with dysphagia with their own mobility and relatively healthy cognitive function, free access to water did not result in aspiration pneumonia, improved measures of hydration and in particular, significantly increased quality of life when compared to a diet consisting of thickened fluids only. Overall, we conclude that in people with good mobility and cognitive ability, there is no need to deviate from the Frazier Rehabilitation Centre free water protocol, which allows for the provision of water to people with dysphagia with strict guidelines particularly in relation to good physical ability. PMID:24392465

Karagiannis, Martha; Karagiannis, Tom C

2014-01-01

290

SEM/TIMS analysis trials on hotswipe samples taken from a shielded cell at Harwell  

International Nuclear Information System (INIS)

The IAEA require advanced techniques and procedures for the detection of traces of actinides to be applied to their environmental sampling programme for nuclear safeguards as a means to detect undeclared activities. 'Swipe' samples taken from within nuclear facilities by IAEA inspectors require analysis to determine their actinide content and composition by bulk and particle measurements. The use of analytical equipment capable of analysing individual particles, particularly of actinides, is essential to optimise the IAEA's aim to monitor Member State's nuclear activities more proficiently. A trial has been undertaken at the Harwell Laboratory of AEA Technology to establish the efficacy of scanning electron microscopy (SEM) and thermal ionisation mass spectrometry (TIMS) for the particle and bulk characterisation, respectively, of actinides on samples taken from within a shielded cell. These measurements were supported by ?-spectrometry and ?-spectrometry. 'Hotswipe' samples taken from within a shielded cell with a well-known recent history have been prepared for particle and bulk analysis. SEM has been used to characterise individual particles from the swipe samples and the results have been related to known cell activities. Samples were prepared for SEM using a simple procedure to minimise the potential for sample contamination. The method proved to be capable of identifying 1 ?m particles that contained U, Pu, Pa and Np. The measurement of U/Pu ratios was limited to particles that contained >2% Pu in U by weight. TIMS, together with alpha spectrometry, has been used to determine the bulk actinide composition of the samples whilst gamma spectrometry has been used to determine the fission product composition. Further work to improve the potential of SEM, and also secondary ionisation mass spectrometry (SIMS), for the measurement of hotswipe samples has been proposed. (author)

1998-01-01

291

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

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Abstract Background Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. Methods Deta...

2012-01-01

292

Trial-by-Trial Adjustments of Cognitive Control Following Errors and Response Conflict are Altered in Pediatric Obsessive Compulsive Disorder  

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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 adjustments of cognitive control characterize 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...

Liu, Yanni; Gehring, William J.; Weissman, Daniel H.; Taylor, Stephan F.; Fitzgerald, Kate Dimond

2012-01-01

293

Delaying the oocyte maturation trigger by one day leads to a higher metaphase II oocyte yield in IVF/ICSI: a randomised controlled trial  

Science.gov (United States)

Background The negative impact of rising progesterone levels on pregnancy rates is well known, but data on mature oocyte yield are conflicting. We examined whether delaying the oocyte maturation trigger in IVF/ICSI affected the number of mature oocytes and investigated the potential influence of serum progesterone levels in this process. Methods Between January 31, 2011, and December 31, 2011, 262 consecutive patients were monitored using ultrasound plus hormonal evaluation. Those with?>?=3 follicles with a mean diameter of?>?=18 mm were divided into 2 groups depending on their serum progesterone levels. In cases with a progesterone level??1 ng/ml were randomised in the same manner, irrespective of the percentage of larger follicles (>?=?18 mm). The number of metaphase II oocytes was our primary outcome variable. Because some patients were included more than once, correction for duplicate patients was performed. Results In the study arm with low progesterone (1 ng/ml), the mean numbers of metaphase II oocytes (+/-SD) were 11.81 (+/-9.91) and 12.03 (+/-7.09) for the delayed and control groups, respectively. After adjusting for PCOS (polycystic ovary syndrome) and female pathology, the mean difference was -0.44 (95% CI: -3.65-2.78; p?=?0.79). Conclusions Delaying oocyte maturation in patients with low progesterone levels yields greater numbers of mature oocytes. Trial registration B67020108975 (Belgian registration) and NCT01980563 (ClinicalTrials.gov).

2014-01-01

294

Media reporting of tenofovir trials in Cambodia and Cameroon  

Directory of Open Access Journals (Sweden)

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.

Wong Elaine

2005-08-01

295

A Comparison of In-Context and Traditional Instructional Approaches: Total Task, Single Trial versus Backward Chaining, Multiple Trials.  

Science.gov (United States)

Total task (single trial instruction) and backward chaining (multiple trials instruction) were used to teach eight children with severe handicaps. Total task, single trial instruction resulted in superior acquisition of independent steps in the training setting for three students. In all cases, instructional time was substantially less for total…

Kayser, Joan E.; And Others

1986-01-01

296

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)

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.

YanniLiu

2012-05-01

297

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

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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 we...

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

2011-01-01

298

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

Directory of Open Access Journals (Sweden)

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.

Heger Ulrike

2011-11-01

299

Coping with Trial-to-Trial Variability of Event Related Signals: A Bayesian Inference Approach  

Science.gov (United States)

In electro-neurophysiology, single-trial brain responses to a sensory stimulus or a motor act are commonly assumed to result from the linear superposition of a stereotypic event-related signal (e.g. the event-related potential or ERP) that is invariant across trials and some ongoing brain activity often referred to as noise. To extract the signal, one performs an ensemble average of the brain responses over many identical trials to attenuate the noise. To date, h s simple signal-plus-noise (SPN) model has been the dominant approach in cognitive neuroscience. Mounting empirical evidence has shown that the assumptions underlying this model may be overly simplistic. More realistic models have been proposed that account for the trial-to-trial variability of the event-related signal as well as the possibility of multiple differentially varying components within a given ERP waveform. The variable-signal-plus-noise (VSPN) model, which has been demonstrated to provide the foundation for separation and characterization of multiple differentially varying components, has the potential to provide a rich source of information for questions related to neural functions that complement the SPN model. Thus, being able to estimate the amplitude and latency of each ERP component on a trial-by-trial basis provides a critical link between the perceived benefits of the VSPN model and its many concrete applications. In this paper we describe a Bayesian approach to deal with this issue and the resulting strategy is referred to as the differentially Variable Component Analysis (dVCA). We compare the performance of dVCA on simulated data with Independent Component Analysis (ICA) and analyze neurobiological recordings from monkeys performing cognitive tasks.

Ding, Mingzhou; Chen, Youghong; Knuth, Kevin H.; Bressler, Steven L.; Schroeder, Charles E.

2005-01-01

300

Ranibizumab: Phase III clinical trial results.  

Science.gov (United States)

Ranibizumab therapy is the first treatment for neovascular AMD to improve vision for most patients. The benefits apply to all angiographic subtypes of neovascular AMD and across all lesion sizes. Although the pivotal phase III trials (MARINA and ANCHOR) used monthly injections of ranibizumab for 2 years, the ongoing PIER, PrONTO, and SAILOR trials are investigating less frequent dosing regimens, and preliminary results from the PrONTO study suggest that fewer injections will most likely result in visual acuity improvements similar to the results from the phase III trials. When comparing the ANCHOR results with the FOCUS results, it also becomes apparent that the combination of ranibizumab with PDT does not necessarily result in better visual acuity outcomes, and the use of PDT may even reduce the visual acuity benefits achieved with ranibizumab alone (see Figs. 1-3). It seems unlikely that combination therapy provides any significant advantage over ranibizumab alone unless the combination of PDT and ranibizumab can decrease the need for frequent retreatment. The results from the PrONTO Study already suggest that less frequent treatment with ranibizumab is possible by using a variable dosing regimen with OCT. Ranibizumab also seems to be safe, with the 2-year MARINA data showing no increase in the incidence of systemic adverse events that could be associated with anti-VEGF therapy, such as myocardial infarction and stroke. There was a hint of a safety concern, however, in the pooled 1-year safety results from the MARINA and ANCHOR trials. Although the combined rate of myocardial infarction and stroke during the first year of the ANCHOR and MARINA trials was similar in the control and the 0.3-mg ranibizumab arms (1.3% and 1.6% respectively), these adverse events were slightly higher in the 0.5-mg ranibizumab arm (2.9%). These differences are not statistically significant, however, and probably do not represent a dose-dependent increase in risk because the 2-year results from the MARINA trial with the same monthly injection regimen showed no increased risk of thromboembolic events. In December 2005, Genentech submitted a Biologics License Application to the FDA for the use of ranibizumab in the treatment of neovascular wet AMD based on 1-year clinical efficacy and safety data from the two pivotal phase III trials, ANCHOR and MARINA, and the phase I-II FOCUS trial. Genentech has been granted a 6-month Priority Review from the FDA with a decision anticipated 6 months from the December submission date or by the end of June 2006 [29]. By the summer of 2006, this revolutionary therapy should be available for the treatment of neovascular AMD. At that time, the major dilemma facing most retina specialists will be whether to use intravitreal ranibizumab or intravitreal bevacizumab, the low cost alternative, for the treatment of neovascular AMD. PMID:16935211

Rosenfeld, Philip J; Rich, Ryan M; Lalwani, Geeta A

2006-09-01

 
 
 
 
301

Annual technical report. PV domestic field trial  

Energy Technology Data Exchange (ETDEWEB)

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.

NONE

2002-07-01

302

First clinical trial with iohexol in myelography  

Energy Technology Data Exchange (ETDEWEB)

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.

Lossius, R.; Eldevik, O.P.; Weber, H.; Oftedal, S.I.; Stroemme, J.H. (Ullevaal Sykehus, Oslo (Norway))

1983-01-01

303

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.)

1983-01-01

304

On the Complexity of Trial and Error  

CERN Document Server

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,...

Bei, Xiaohui; Zhang, Shengyu

2012-01-01

305

Seven myths of randomisation in clinical trials.  

Science.gov (United States)

I consider seven misunderstandings that may be encountered about the nature, purpose and properties of randomisation in clinical trials. Some concern the practical realities of clinical research on patients. Others are to do with the value and purpose of balance. Still others are to do with a confusion about the role of conditioning in valid statistical inference. I consider a simple game of chance involving two dice to illustrate some points about inference and then consider the seven misunderstandings in turn. I conclude that although one should not make a fetish of randomisation, when proposing alternatives to randomisation in clinical trials, one should be very careful to be precise about the exact nature of the alternative being considered if one is to avoid the danger of underestimating the advantages that randomisation can offer. PMID:23255195

Senn, Stephen

2013-04-30

306

Phase III prostate cancer chemoprevention trials.  

Science.gov (United States)

Chemoprevention refers to the use of pharmacologic interventions to delay, prevent, or reverse carcinogenesis with the ultimate goal of reducing cancer incidence. Two large, population-based, phase 3 prostate cancer prevention trials reported that 5-alpha reductase inhibitors significantly reduce prostate cancer risk. However, this class of agents were also associated with increased detection of high-grade prostate cancer. Another large, phase 3 prostate cancer prevention clinical trial showed no benefit for long-term supplementation with the trace element Se, given in the form of selenomethionine, or vitamin E, either individually or in combination. Paradoxically, a significant increase in prostate cancer was observed among men randomized to receive vitamin E alone. A great deal of progress had been made in the field of prostate cancer prevention over the past decade. Future studies will focus on prevention of disease progression in men on Active Surveillance, immunotherapy, mechanistically based drug combinations, and novel biomarkers of risk and benefit. PMID:24531780

Parnes, Howard L; Brawley, Otis W; Minasian, Lori M; Ford, Leslie G

2014-01-01

307

Famous Trials: UMKC School of Law, Prof. Douglas Linder  

Science.gov (United States)

Created by Professor Doug Linder of the University of Missouri-Kansas City Law School, this site tells the stories of twelve famous trials from American history with a mix of images, primary documents, and Linder's own analysis and overviews. Some of the trials featured include the "Scottsboro Boys," the Chicago Seven, the Rosenbergs, the My Lai Courts Martial, and the Scopes "Monkey" trial. Most of the trial studies include biographical sketches, chronologies, maps (where appropriate), a number of complete or excerpted original documents, quotes from trial participants, images, bibliography and links, and Linder's description and commentary.

Linder, Douglas O.

308

End points and clinical trial design in pulmonary arterial hypertension.  

Science.gov (United States)

New and emerging therapies might provide benefit in patients with pulmonary arterial hypertension. Their efficacy and safety will be compared with existing combination therapies in randomized clinical trials. Appropriate end points for these trials need to be identified: these will include exercise testing, the composite end point of time to clinical worsening, and hemodynamic markers, including advanced imaging modalities and biomarkers. Quality-of-life questionnaires are useful and important secondary end points; pulmonary arterial hypertension-specific questionnaires are currently being developed. Advantages and disadvantages of various trial designs, including placebo-controlled monotherapy or add-on trials, noninferiority studies, and withdrawal trials are also discussed. PMID:19555863

McLaughlin, Vallerie V; Badesch, David B; Delcroix, Marion; Fleming, Thomas R; Gaine, Sean P; Galiè, Nazzareno; Gibbs, J Simon R; Kim, Nick H; Oudiz, Ronald J; Peacock, Andrew; Provencher, Steeve; Sitbon, Olivier; Tapson, Victor F; Seeger, Werner

2009-06-30

309

Randomised clinical trial of chest drainage systems.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

BACKGROUND: Problems in the management of thoracic trauma have stimulated the search for an alternative to underwater seals for drainage of the pleural cavity. A chest drainage bag incorporating a one way flutter valve has been compared with underwater seal drains in a randomised clinical trial. METHODS: During June-December 1989 119 patients undergoing elective thoracotomy were randomised to receive postoperative chest drainage by drainage bags (56 patients, 87 drains) or by underwater seal ...

Sarniak, R. M.

1992-01-01

310

Improved Endpoints for Cancer Immunotherapy Trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Unlike chemotherapy, which acts directly on the tumor, cancer immunotherapies exert their effects on the immune system and demonstrate new kinetics that involve building a cellular immune response, followed by changes in tumor burden or patient survival. Thus, adequate design and evaluation of some immunotherapy clinical trials require a new development paradigm that includes reconsideration of established endpoints. Between 2004 and 2009, several initiatives facilitated by the Cancer Immunot...

Hoos, Axel; Eggermont, Alexander M. M.; Janetzki, Sylvia; Hodi, F. Stephen; Ibrahim, Ramy; Anderson, Aparna; Humphrey, Rachel; Blumenstein, Brent; Old, Lloyd; Wolchok, Jedd

2010-01-01

311

Improved endpoints for cancer immunotherapy trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Unlike chemotherapy, which acts directly on the tumor, cancer immunotherapies exert their effects on the immune system and demonstrate new kinetics that involve building a cellular immune response, followed by changes in tumor burden or patient survival. Thus, adequate design and evaluation of some immunotherapy clinical trials require a new development paradigm that includes reconsideration of established endpoints. Between 2004 and 2009, several initiatives facilitated by the Cancer Immunot...

Hoos, A.; Eggermont, A. M. M.; Janetzki, S.; Hodi, F. S.; Ibrahim, R.; Anderson, A.; Humphrey, R.; Blumenstein, B.; Old, L.; Wolchok, J.

2010-01-01

312

Propensity Score Matching in Randomized Clinical Trials  

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

Xu, Zhenzhen; Kalbfleisch, John D.

2010-01-01

313

Reinforcement learning design for cancer clinical trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

We develop reinforcement learning trials for discovering individualized treatment regimens for life-threatening diseases such as cancer. A temporal-difference learning method called Q-learning is utilized which involves learning an optimal policy from a single training set of finite longitudinal patient trajectories. Approximating the Q-function with time-indexed parameters can be achieved by using support vector regression or extremely randomized trees. Within this framework, we demonstrate ...

Zhao, Yufan; Kosorok, Michael R.; Zeng, Donglin

2009-01-01

314

Balance algorithm for cluster randomized trials  

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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 h...

Carter Ben R; Hood Kerenza

2008-01-01

315

Marketing and clinical trials: a case study  

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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 analy...

2007-01-01

316

Methodological Issues in Current Antipsychotic Drug Trials  

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Every year numerous reports on antipsychotic drug trials are being published in neuropsychiatric journals, adding new information to our knowledge in the field. The information however is often hard for the reader to interpret, sometimes contradictory to comparable available studies and leaves more questions open than it actually answers. Although the overall quality of the studies is rather good, there are manifold options for further improvement in the conception, conduct, and reporting of ...

Leucht, Stefan; Heres, Stephan; Hamann, Johannes; Kane, John M.

2008-01-01

317

Clinical and Therapeutic Trials of Nigella Sativa  

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Seeds of Nigella sativa (N. sativa) have been used for thousands of years as a spice and food preservative. The oil and seed constituents have shown potential medicinal properties in traditional medicine. This review lists and discusses different therapeutic trials of N. sativa seeds and its active ingredients in many diseases affecting body systems. It has anti?oxidant effects through enhancing the oxidant scavenger system that leads to antitoxic effects induced by several insults. Its ...

2010-01-01

318

Incidental Diagnosis in Healthy Clinical Trial Subjects  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Previously unrecognized medical conditions identified in volunteers for early phase clinical studies have significant clinical and ethical implications for the participant. It is therefore crucial that the potential for unexpected diagnosis is addressed during the informed consent process. But the frequency of incidental diagnosis in healthy volunteers who attend for clinical trial screening remains unclear. To assess this we retrospectively analyzed 1,131 independent screening visits for 990...

Duncan, Christopher Ja; Rowland, Rosalind; Lillie, Patrick J.; Meyer, Joel; Sheehy, Susanne H.; O Hara, Geraldine A.; Hamill, Matthew; Donaldson, Hannah; Dinsmore, Laura; Poulton, Ian D.; Gilbert, Sarah C.; Mcshane, Helen; Hill, Adrian Vs

2012-01-01

319

A comparative trial of liver biopsy needles.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

A sheathed needle (Tru-Cut) was compared with a suction biopsy needle (Menghini) in a randomised prospective trial over 18 months to determine whether the former offered any special advantages in routine percutaneous liver biopsy. Seventy-seven consecutive biopsies were performed by a single operator. Although biopsy fragmentation was commoner with the suction needle, the length and volume of the largest core obtained was similar to results with the sheathed needle. Cytology provided useful a...

1980-01-01

320

Unimed Pharmaceuticals begins HIV wasting syndrome trial.  

Science.gov (United States)

Unimed Pharmaceuticals announced the beginning of a phase II trial to test the safety and efficacy of Androgel-DHT (dihydrotestosterone gel) for treating HIV wasting syndrome and low testosterone levels in AIDS patients. The gel delivers the hormone by being absorbed into the skin. The company has also notified the FDA that this product qualifies for orphan drug designation for treating weight loss in AIDS patients. PMID:11363535

1996-05-01

 
 
 
 
321

ADEPT - Abnormal Doppler Enteral Prescription Trial  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Background Pregnancies complicated by abnormal umbilical artery Doppler blood flow patterns often result in the baby being born both preterm and growth-restricted. These babies are at high risk of milk intolerance and necrotising enterocolitis, as well as post-natal growth failure, and there is no clinical consensus about how best to feed them. Policies of both early milk feeding and late milk feeding are widely used. This randomised controlled trial aims to determin...

Leaf Alison; Dorling Jon; Kempley Steve; McCormick Kenny; Mannix Paul; Brocklehurst Peter

2009-01-01

322

Self admission for myocardial infarction. Controlled trial.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

In a randomised controlled trial of 511 men under 65 followed for 1451 man/years, half the patients were invited to readmit themselves to hospital if ischaemic pain recurred. The majority of such patients who were readmitted took advantage of the scheme. There was no evidence that they admitted themselves unnecessarily. Time from the onset of pain to admission was significantly reduced in those who made use of the scheme. All of the seven successful resuscitations among patients readmitted oc...

Reynell, P. C.

1983-01-01

323

Women’s health and clinical trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Women have traditionally been underrepresented in clinical trials. In order to translate recent advances in our understanding of the molecular and physiological bases of sex differences into new therapeutics and health practices, sound sex-specific clinical data are imperative. Since the founding of the Office of Research on Women’s Health within the Office of the Director at the NIH in 1990, inequities in federally funded biomedical research, diagnosis, and treatment of diseases affecting ...

2003-01-01

324

Postregistration trials: should we? How do we?  

Science.gov (United States)

Postregistration trials or postmarketing or phase IV trials are tools to investigate any treatment that is already approved and is, therefore, available for prescription use. The main objectives of these trials are typical effectiveness, more structured surveillance for uncommon or rare side effects, and the potential development of new indications. Several issues need to be addressed in the postregistration phase of the evaluation of a therapeutic treatment. Among those we will focus on two ethical challenges: reporting bias from industry-sponsored research and use of placebo as one of the arms in controlled studies where proven treatment already exists. The review of this topic is particularly relevant in the field of critical care because it is ongoing in the debate about the opportunity to perform a new placebo-controlled study with the recombinant human activated protein C (activated drotrecogin alfa-activated protein C). In fact, despite the approval of activated protein C for treatment of patients with severe sepsis and high risk of death, several issues regarding the efficacy and safety of its administration have been recognized by several investigators to the point that the European Medicines Agency asked for a new placebo-controlled study to further clarify the benefit/risk profile of activated protein C. PMID:19104216

Del Sorbo, Lorenzo; Thompson, B Taylor; Ranieri, V Marco

2009-01-01

325

Treat-to-target trials in diabetes.  

Science.gov (United States)

Treat-to-target is a therapeutic concept that considers well defined and specific physiologic targets as aims in controlling the pathophysiology of the disease. It has been widely used in diseases that pathophysiology includes, chronic metabolic and physiological disturbances, namely rheumatic conditions, vascular medicine and diabetes. In diabetes, the availability of "gold-standard" quantitative measures like fasting plasma glucose and glycated hemoglobin make the application of treat-to-target trials especially pertinent. Treatment modalities which have used single therapeutic agents or combinations or in combination with a variety of titration algorithms and implementation protocols have broadened our understanding of diabetes management with specific reference to insulin initiation and maintenance. Treat-to-target trials have been used to investigate a wide variety of questions including efficacy, safety, effect of treatment on comorbidities and patient satisfaction, ideal mechanisms to implement insulin initiation etc. A more generalized acceptance and implementation of treat-to-target trials may finally revolutionize diabetes management by combining aspects of individual care with standard treatment protocols. PMID:24741511

Wangnoo, Subhash K; Sethi, Bipin; Sahay, Rakesh K; John, Mathew; Ghosal, Samit; Sharma, Surendra K

2014-03-01

326

Clinical trials for stem cell therapies  

Directory of Open Access Journals (Sweden)

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

Lomax Geoff

2011-05-01

327

Treat-to-target trials in diabetes  

Science.gov (United States)

Treat-to-target is a therapeutic concept that considers well defined and specific physiologic targets as aims in controlling the pathophysiology of the disease. It has been widely used in diseases that pathophysiology includes, chronic metabolic and physiological disturbances, namely rheumatic conditions, vascular medicine and diabetes. In diabetes, the availability of “gold-standard” quantitative measures like fasting plasma glucose and glycated hemoglobin make the application of treat-to-target trials especially pertinent. Treatment modalities which have used single therapeutic agents or combinations or in combination with a variety of titration algorithms and implementation protocols have broadened our understanding of diabetes management with specific reference to insulin initiation and maintenance. Treat-to-target trials have been used to investigate a wide variety of questions including efficacy, safety, effect of treatment on comorbidities and patient satisfaction, ideal mechanisms to implement insulin initiation etc. A more generalized acceptance and implementation of treat-to-target trials may finally revolutionize diabetes management by combining aspects of individual care with standard treatment protocols.

Wangnoo, Subhash K.; Sethi, Bipin; Sahay, Rakesh K.; John, Mathew; Ghosal, Samit; Sharma, Surendra K.

2014-01-01

328

Evaluation of eligibility and recruitment in breast cancer clinical trials.  

Science.gov (United States)

Objectives of the study were to measure recruitment rates in clinical trials and to identify patients, physicians or trials characteristics associated with higher recruitment rates. Among patients who had a clinical trial available for their cancer, 83.5% (345/413) met the eligibility criteria to at least one clinical trial. At least one trial was proposed to 33.1% (113/341) of the eligible patients and 19.7% (68/345) were recruited. Overall recruitment was 16.5% (68/413). In multivariate analyses, trial proposal and enrollment were lower for elderly patients and higher in high cancer stages. Trials from pharmaceutical industry had higher recruitment rates and trials testing hormonal therapy enrolled more patients. Breast cancer patients' accrual to a clinical trial could be improved by trying to systematically identify all eligible patients and propose a trial to those eligible and to whom the treatment is planned to be equivalent to the standard arm of the trial. PMID:24679829

Lemieux, Julie; Forget, Geneviève; Brochu, Olyvia; Provencher, Louise; Cantin, Guy; Desbiens, Christine; Doyle, Catherine; Poirier, Brigitte; Camden, Stéphanie; Durocher, Martin

2014-08-01

329

What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC and the Health Technology Assessment (HTA Programme. Methods The cohort of trials was identified from the administrative databases held by the two funding bodies. 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria. The full scientific applications and subsequent trial reports submitted by the trial teams to the funders provided the principal data sources. Associations between trial characteristics and recruitment success were tested using the Chi-squared test, or Fisher's exact test where appropriate. Results Less than a third (31% of the trials achieved their original recruitment target and half (53% were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41% trials and early recruitment problems were identified in 77 (63% trials. The inter-relationship between trial features and recruitment success was complex. A variety of strategies were employed to try to increase recruitment, but their success could not be assessed. Conclusion Recruitment problems are complex and challenging. Many of the trials in the cohort experienced recruitment difficulties. Trials often required extended recruitment periods (sometimes supported by additional funds. While this is of continuing concern, success in addressing the trial question may be more important than recruitment alone.

Francis David

2006-04-01

330

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

Directory of Open Access Journals (Sweden)

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

Zielinski Stephanie M

2012-01-01

331

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)

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.

Grimshaw Jeremy M

2010-02-01

332

Trial-to-trial fluctuations in attentional state and their relation to intelligence.  

Science.gov (United States)

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 subsequent trial performance on the fluid intelligence measures, such that when participants rated their current attentional state as highly focused on the current task, performance tended to be high compared to when participants reported their current attentional state as being low and unfocused on the current task. Furthermore, overall attentional state ratings and variability in attentional state ratings were moderately correlated with overall levels of performance on the fluid intelligence measures. However, attentional state ratings did not predict performance on the measure of crystallized intelligence. These results suggest a strong link between variation in attention state and variation in fluid intelligence as postulated by a number of recent theories. (PsycINFO Database Record (c) 2014 APA, all rights reserved). PMID:24417327

Unsworth, Nash; McMillan, Brittany D

2014-05-01

333

A model–based approach to trial–by–trial P300 amplitude fluctuations  

Directory of Open Access Journals (Sweden)

Full Text Available It has long been recognized that the amplitude of the P300 component of event–related brain potentials is sensitive to the degree to which eliciting stimuli are surprising to the observers (Donchin, 1981. While Squires et al. (1976 showed and modeled dependencies of P300 amplitudes from observed stimuli on various time scales, Mars et al. (2008 proposed a computational model keeping track of stimulus probabilities on a long–term time scale. We suggest here a computational model which integrates prior information with short–term, long–term, and alternation–based experiential influences on P300 amplitude fluctuations. To evaluate the new model, we measured trial–by–trial P300 amplitude fluctuations in a simple two–choice response time task, and tested the computational models of trial–by–trial P300 amplitudes using Bayesian model evaluation. The results reveal that the new digital filtering (DIF model provides a superior account of the trial–by–trial P300 amplitudes when compared to both, Squires et al.’s (1976 model, and Mars et al.’s (2008 model. We show that the P300–generating system can be described as two parallel first–order infinite impulse response (IIR low–pass filters and an additional fourth–order finite impulse response (FIR high–pass filter. Implications of the acquired data are discussed with regard to the neurobiological distinction between short–term, long–term, and working memory as well as from the point of view of predictive coding models and Bayesian learning theories of cortical function.

TimFingscheidt

2013-02-01

334

Infrastructure needs for translational integration of mouse and human trials.  

Science.gov (United States)

Advances in the treatment of human cancer are frequently limited by the inability to test novel drugs and drug combinations in patients in a rapid and streamlined manner. Increasing data from the application of clinically relevant mouse models has highlighted the ability of preclinical trials in mice to address this problem, and has paved the way for what is now termed the "Co-Clinical Trial Project," in which mouse trials are performed concurrently with human trials. This in turn enables efficient patient stratification and therapy optimization based on molecular determinants for effective treatment of cancer. To fully realize the potential of preclinical, coclinical, and postclinical trials in mice, there is a need to establish key principles for carrying out therapeutic mouse trials, to standardize practices for performing such trials, and to establish mouse hospitals where trials can be integrated with corresponding clinical trial efforts in humans. Here we describe critical infrastructural components that are required for effective implementation of such efforts and suggest a model for how mouse hospitals for clinical trials should be established. PMID:24173312

Clohessy, John G; de Stanchina, Elisa

2013-12-01

335

Key concepts of clinical trials: a narrative review.  

Science.gov (United States)

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

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

2011-09-01

336

Designing implant trials in 2010: a recipe for success.  

Science.gov (United States)

In a recent evaluation of 1017 device trials listed on a clinical trials register (www.clinicaltrials.gov) between 2005 and 2009, only 84 (8.2%) represented orthopedic device evaluations. These device trials notably had few numbers of patients and few centers and represented approximately 7% of drug trials on the same registry. The relatively small proportion of device trials in orthopedics may represent a lack of interest; however, given the device focus of the field, the answer is more likely to be a lack of necessity?historically, regulatory pathways to implant approvals have not required clinical trials and have largely focused on preclinical and early case-series evaluations. The changing landscape of the regulatory environment necessitates a renewed interest in high-quality clinical research. Specifically, randomized trials of implants in orthopedics are poised to become major designs in the future. Given the general uncertainty in knowledge of regulatory pathways among researchers and health care providers, the current symposium was developed to clarify the design and execution of device trials in a changing regulatory environment. We focus our papers on the Food and Drug Administration (FDA) device classes and regulatory pathways (510K), design challenges in regulatory trials, site audits, and standard operating procedures. In over a decade of conducting trials, we have also realized the critical importance of data-management systems and contract research organizations. Not every clinician, device manufacturer, or researcher planning a randomized trial will have the infrastructure or experience to meet the strict regulatory compliance guidelines for the proper conduct of the trial. Understanding what to look for in a contract research organization is extremely helpful, especially in an environment of limited funding and high expectations. We hope that the current symposium will provide a broad context to clinical trials of orthopedic devices. Despite the challenges of the current regulatory arena, there has never been a more exciting time to conduct research in our field. PMID:20939776

Bhandari, Mohit

2009-01-01

337

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)

2011-11-01

338

Trial by Jury in Russian Military Courts  

Digital Repository Infrastructure Vision for European Research (DRIVER)

One of peculiar features of the military criminal justice system in Russia is that in some cases military defendants may apply for trial by jury. Unlike the existing U.S. court-martial jury and the Russian military jury of the early 1900s (World War I period) which were comprised of the members of the armed forces, in modern Russia jurors trying military defendants are civilians. This article aims to provide a brief history of military jury in Russia and identify issues of independence and im...

2008-01-01

339

Analysis and correction of sea trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

2012-01-01

340

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)

1986-01-01

 
 
 
 
341

Waste preparation, handling and storage trials  

Energy Technology Data Exchange (ETDEWEB)

This report summarises the demonstration scheme projects and assesses the preparation, handling and storage equipment utilised. It goes on to discuss the range of size reduction, densification, separation, handling and storage equipment currently available on the market and assesses their suitability for raw, shredded and pelletized waste. Where possible, trials were performed on the more promising technologies with raw, shredded and pelletized waste. In addition a database of equipment suppliers, equipment performance statistics and budget costs was collated and incorporated in a database operated by ECOTEC, which is used to service enquiries. (author).

Evans, D.; Hand, G.

1992-12-31

342

Randomized clinical stroke trials in 2004.  

Science.gov (United States)

Randomized clinical stroke trials published during 2004 dealt primarily with prevention of strokes by reducing risk factors. The usefulness of innovative versions of widely known treatment modalities was documented. These included angiotensin-converting enzyme inhibitors against hypertension, acarabose against diabetes, and the antiplatelet agent triflusal instead of aspirin. A large British study confirmed the value of treatment with simvastatin. Appropriately powered studies found no benefit for stroke prevention of either vitamin treatment to lower homocysteine or hormonal replacement in post-menopausal women. The circumstances under which antithrombotic, anticoagulant and surgical treatments of acute ischemic stroke are appropriate were further specified. PMID:15975326

Rabadi, Meheroz H; Blass, John

2005-07-01

343

Phase III trials of targeted anticancer therapies: redesigning the concept.  

Science.gov (United States)

Randomized phase III trials provide the gold-standard evidence for the approval of new drugs: an experimental treatment is compared with the current standard of care to identify clinically relevant differences in a predefined endpoint. However, there are several problems relating to the current role of phase III trials in drug development including the limited clinical benefit observed for some approved agents, the necessity for large trials to detect these differences, the inability of such trials to identify rare but important toxicities, and high cost. The design of phase III trials evaluating drug combinations, and those including biomarkers, presents additional challenges. Here, we review these problems and suggest that phase III trials with adaptive designs in selected prescreened populations could reduce these limitations. PMID:23881926

Ocana, Alberto; Amir, Eitan; Vera-Badillo, Francisco; Seruga, Bostjan; Tannock, Ian F

2013-09-15

344

Impact, Challenges, and Future Projections of Vaccine Trials in Africa  

Science.gov (United States)

Immunization remains the most cost effective method for the control of infectious diseases. Therefore, there is a global effort to deploy new vaccines for disease control and eradication. These new vaccines must be tested in the settings in which they will be used. This necessity has required the conduct of many vaccine trials in Africa, where several infectious diseases with significant public health impact are prevalent. However, these areas have peculiarities and are just beginning to gain expertise in the conduct of such trials. The vaccine developers and sponsors of these trials may also not be conversant with some issues unique to the trial site. The understanding gap from both partners can result in challenges if not addressed during the planning phase of the trial. This review seeks to highlight the issues surrounding the conduct of clinical trials in resource-constrained settings and suggests some ways of circumventing them.

Idoko, Olubukola T.; Kochhar, Sonali; Agbenyega, Tsiri E.; Ogutu, Bernhards; Ota, Martin O. C.

2013-01-01

345

Design of clinical trials in acute kidney injury: report from an NIDDK workshop on trial methodology.  

Science.gov (United States)

Acute kidney injury (AKI) remains a complex clinical problem associated with significant short-term morbidity and mortality and lacking effective pharmacologic interventions. Patients with AKI experience longer-term risks for progressive chronic ESRD, which diminish patients' health-related quality of life and create a larger burden on the healthcare system. Although experimental models have yielded numerous promising agents, translation into clinical practice has been unsuccessful, possibly because of issues in clinical trial design, such as delayed drug administration, masking of therapeutic benefit by adverse events, and inadequate sample size. To address issues of clinical trial design, the National Institute of Diabetes and Digestive and Kidney Diseases sponsored a workshop titled "Clinical Trials in Acute Kidney Injury: Current Opportunities and Barriers" in December 2010. Workshop participants included representatives from academia, industry, and government agencies whose areas of expertise spanned basic science, clinical nephrology, critical care medicine, biostatistics, pharmacology, and drug development. This document summarizes the discussions of collaborative workgroups that addressed issues related to patient selection, study endpoints, the role of novel biomarkers, sample size and power calculations, and adverse events and pilot/feasibility studies in prevention and treatment of AKI. Companion articles outline the discussions of workgroups for model trials related to prevention or treatment of established AKI in different clinical settings, such as in patients with sepsis. PMID:22442182

Palevsky, Paul M; Molitoris, Bruce A; Okusa, Mark D; Levin, Adeera; Waikar, Sushrut S; Wald, Ron; Chertow, Glenn M; Murray, Patrick T; Parikh, Chirag R; Shaw, Andrew D; Go, Alan S; Faubel, Sarah G; Kellum, John A; Chinchilli, Vernon M; Liu, Kathleen D; Cheung, Alfred K; Weisbord, Steven D; Chawla, Lakhmir S; Kaufman, James S; Devarajan, Prasad; Toto, Robert M; Hsu, Chi-yuan; Greene, Tom; Mehta, Ravindra L; Stokes, John B; Thompson, Aliza M; Thompson, B Taylor; Westenfelder, Christof S; Tumlin, James A; Warnock, David G; Shah, Sudhir V; Xie, Yining; Duggan, Emily G; Kimmel, Paul L; Star, Robert A

2012-05-01

346

The Beta Agonist Lung Injury TrIal (BALTI) - prevention trial protocol  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Background Acute lung injury complicates approximately 25-30% of subjects undergoing oesophagectomy. Experimental studies suggest that treatment with beta agonists may prevent the development of acute lung injury by decreasing inflammatory cell infiltration, activation and inflammatory cytokine release, enhancing basal alveolar fluid clearance and improving alveolar capillary barrier function. Methods/Design The Beta Agonist Lung Injury TrIal (preventio...

Perkins Gavin D; Park Daniel; Alderson Derek; Cooke Matthew W; Gao Fang; Gates Simon; Lamb Sarah E; Mistry Dipesh; Thickett David R

2011-01-01

347

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

DEFF Research Database (Denmark)

The TORCH (Towards a Revolution in COPD Health) trial has highlighted some important issues in the design and analysis of long term trials in chronic obstructive pulmonary disease. These include collection of off-treatment exacerbation data, analysis of exacerbation rates and the effect of inclusion of patients receiving inhaled corticosteroids (ICS) prior to randomisation. When effective medications are available to patients who withdraw, inclusion of off-treatment data can mask important treatment effects on exacerbation rates. Analysis of on-treatment data avoids this bias but it needs to 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 among patients with previous use of ICS compared to those with no prior use on all study treatments. Retrospective subgroup analysis suggests ICS reduced exacerbation rates compared with placebo, regardless of prior use of ICS before entry to the study. Factorial analysis provides an alternative analysis for trials with combinations of treatments, but assumes no interaction between treatments, an assumption which cannot be verified by a significance test. No definitive conclusions can yet be drawn on whether ICS treatment has an effect on mortality.

Keene, O N; Vestbo, J

2009-01-01

348

Grassroots Campaign Trail Methods to Recruit for Clinical Trials: Recruitment Lessons Learned from Trail to Trial  

Science.gov (United States)

Background: Literature reviews have identified recruitment as the single most challenging obstacle in conducting pediatric trials. This paper describes a paradigm shift in recruitment design, developed from experience with grassroots campaigns through the DRINK study (Decreasing the Rates of Illness in Kids). The objective of this study was to explain a new method for recruiting in clinical trials based on lessons learned from grassroots political campaigning. Methods and findings: The study described is a randomized controlled trial of 638 3–6 year olds from the Washington, DC Area. The design involved a comparison between new recruiting approaches modeled after grassroots campaigns and traditional techniques. Traditional techniques for the purpose of this paper are defined by the use of physician referral, mass media such as radio and television advertisements, along with posters in public places like the subway. Grassroots approaches alternatively developed and utilized community contacts and employed targeted small market media community. The main outcome measures were the percentage of budget used and the number of eligible participants recruited. Conclusions: The results showed that the grassroots recruitment approach saved 30% of the budget, recruited 638 kids in 4 months and retained over 90% for the 90 day trial. New techniques need further exploration as community studies are stressed.

Murphy, Megan; Merenstein, Daniel

2011-01-01

349

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

Directory of Open Access Journals (Sweden)

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

Tappin David M

2012-07-01

350

Drug safety assessment in clinical trials: methodological challenges and opportunities  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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 challeng...

Singh, Sonal; Loke, Yoon K.

2012-01-01

351

Data retention after a patient withdraws consent in clinical trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Gabriel A; Cp, Mercado

2011-01-01

352

Advances in designs for Alzheimer’s disease clinical trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

There is an urgent need to identify new treatments for the rapidly growing population of people with Alzheimer’s disease (AD). Innovations in clinical trial designs many help to reduce development time, provide more definitive answers regarding drug efficacy, and facilitate prioritizing compounds to be advanced to Phase III clinical trials. Standard designs compare drug and placebo changes from baseline on a rating scale. Baysian adaptive clinical trials allow the use of data collected in t...

Cummings, Jeffrey; Gould, Heath; Zhong, Kate

2012-01-01

353

Key Concepts of Clinical Trials: A Narrative Review  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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 ...

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

2011-01-01

354

Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial  

Science.gov (United States)

The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial is a large-scale clinical trial to determine whether certain cancer screening tests reduce deaths from prostate, lung, colorectal, and ovarian cancer. The underlying rationale for the trial is that screening for cancer may enable doctors to discover and treat the disease earlier. Numerous epidemiologic and ancillary studies are included to answer related crucial questions.

355

Shining light on vitamin D trials in chronic kidney disease.  

Science.gov (United States)

Vitamin D compounds may have extraskeletal functions. Chronic kidney disease (CKD) offers an opportunity to investigate these actions, as vitamin D deficiency is prevalent in this population and actions of vitamin D such as those on the heart and glucose metabolism are highly relevant. However, recent randomized controlled trials have tempered enthusiasm. We appraise a trial by de Boer et al. that addresses effects of paricalcitol on glucose metabolism in CKD, and offer perspectives on future trials. PMID:23364588

Nigwekar, Sagar U; Thadhani, Ravi I

2013-02-01

356

The perils of PCR: can we accurately 'correct' antimalarial trials?  

Science.gov (United States)

During follow-up in antimalarial drug trials, treated subjects can be newly infected. PCR correction is used to distinguish this re-infection from drug failure (recrudescence) and to adjust final drug efficacy estimates. The epidemiological, biological and technical limitations of PCR correction and how this may lead to misclassification in drug trial outcomes are underappreciated. This article considers these limitations and proposes a framework for reporting, interpreting, and improving PCR correction of antimalarial trials.

Juliano, Jonathan J; Gadalla, Nahla; Sutherland, Colin J.; Meshnick, Steven R

2010-01-01

357

Media reporting of tenofovir trials in Cambodia and Cameroon  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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. <...

Mills Edward; Rachlis Beth; Wu Ping; Wong Elaine; Wilson Kumanan; Singh Sonal

2005-01-01

358

Open-access clinical trial registries: the Italian scenario  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Background Citizens, patients and their representatives are increasingly insisting on working with health professionals to organize and discuss research protocols. The International Committee of Medical Journal Editors recommended setting up a public clinical trial registry where anyone can find key information about a trial. Around the world, governments have, in fact, now begun to legislate mandatory disclosure of all clinical trials. The aims of the present survey...

Mosconi Paola; Roberto Anna

2012-01-01

359

Application of remote sensing to agricultural field trials.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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...

Clevers, J. G. P. W.

1986-01-01

360

Targeting targeted agents: open issues for clinical trial design  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Molecularly targeted agents for the treatment of solid tumors had entered the market in the last 5 years, with a great impact upon both the scientific community and the society. Many randomized phase III trials conducted in recent years with new targeted agents, despite previous data coming from preclinical research and from phase II trials were often promising, have produced disappointingly negative results. Some other trials have actually met their primary endpoint, demonstrating a statisti...

Bria, Emilio; Di Maio, Massimo; Carlini, Paolo; Cuppone, Federica; Giannarelli, Diana; Cognetti, Francesco; Milella, Michele

2009-01-01

 
 
 
 
361

Leucaena leucocephala trials in Uttar Pradesh (India)  

Energy Technology Data Exchange (ETDEWEB)

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.

Chaturvedi, A.N.

1981-10-01

362

Economic analysis in randomized control trials.  

Science.gov (United States)

In medical technology assessment, randomized control trials (RCTs) play an important role in determining the relative efficacy of compared treatments. As scarce resources necessitate choosing among options for care, comparing costs of alternative tests, treatments, or programs also becomes important. This study assessed the prevalence and completeness of economic analyses in RCTs published from January 1966 through June 1988. It was found that only 121 of over 50,000 published randomized trials (0.2%) included economic analyses. For a random sample of 51 of these 121 studies, results revealed a mean quality of research score of 0.32 (SD of measurement = 0.14) and a mean economic analysis completeness score of 0.52 (SD = 0.13) on scales of 0 to 1. It was also found that higher economic completeness scores were positively correlated with later dates of publication (r = 0.28, P = 0.046) and with the presence of a statement of study perspective (r = 0.38, P = 0.006). A near-zero correlation between the economic completeness and the quality of research scores was revealed. Also noted were several deficiencies among the economic analyses, including improper allocation of overhead costs, absence of sensitivity analyses, and the fact that only 28% of the 51 studies included some form of aggregation of treatment costs and consequences. Progress in health care depends on accurate assessments of both relative efficacy and costs. The quality of both needs improvement. PMID:1538611

Adams, M E; McCall, N T; Gray, D T; Orza, M J; Chalmers, T C

1992-03-01

363

Analyzing acute procedural pain in clinical trials.  

Science.gov (United States)

Because acute procedural pain tends to increase with procedure time, assessments of pain management strategies must take that time relationship into account. Statistical time-course analyses are, however, complex and require large patient numbers to detect differences. The current study evaluated the abilities of various single and simple composite measures such as averaged pain or individual patient pain slopes to detect treatment effects. Secondary analyses were performed with the data from 3 prospective randomized clinical trials that assessed the effect of a self-hypnotic relaxation intervention on procedural pain, measured every 10-15minutes during vascular/renal interventions, breast biopsies, and tumor embolizations. Single point-in-time and maximal pain comparisons were poor in detecting treatment effects. Linear data sets of individual patient slopes yielded the same qualitative results as the more complex repeated measures analyses, allowing the use of standard statistical approaches (eg, Kruskal-Wallis), and promising analyses of smaller subgroups, which otherwise would be underpowered. With nonlinear data, a simple averaged score was highly sensitive in detecting differences. Use of these 2 workable and relatively simple approaches may be a first step towards facilitating the development of data sets that could enable meta-analyses of data from acute pain trials. PMID:24731852

Lang, Elvira V; Tan, Gabriel; Amihai, Ido; Jensen, Mark P

2014-07-01

364

Bamboo as Soil Reinforcement: A Laboratory Trial  

Directory of Open Access Journals (Sweden)

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

Alhaji Mohammed MUSTAPHA

2008-12-01

365

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

Directory of Open Access Journals (Sweden)

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

Forster Anne

2011-06-01

366

Angiographic outcomes contradict platelet data in the PLATO trial: confusion over official trial substudies.  

Science.gov (United States)

Major indication-seeking phase 3 clinical trials usually include numerous subanalyses and substudies designed to facilitate the interpretation of results, often providing putative mechanisms that might explain clinical outcomes. Such subanalyses and/or substudies may focus on socioeconomic implications, cost-effectiveness, biomarker applicability, subgroup analyses, etc. Novel antiplatelet agents may benefit from substudies aimed at elucidating the effects on platelets, while angiographic data are also essential for the adequate assessment of coronary flow. Ideally, the data yielded from substudies should correlate well with the main results of the trial. However, in the PLATO (PLATelet Inhibition and Clinical Outcomes) trial, official angiographic data (PLATO-A) contradict platelet (PLATO-P) substudy results. While the large (n = 2,616) PLATO-A concluded that coronary flow and myocardial perfusion were almost identical after ticagrelor or clopidogrel, the small (n = 24) single-center PLATO-P suggested that ticagrelor achieved a highly significantly greater antiplatelet effect compared to clopidogrel after loading in patients enrolled in the same trial and at similar time points. In contrast to PLATO-P, PLATO-A corresponds well with clinical outcomes including the early percutaneous coronary intervention 'ticagrelor death paradox' in PLATO-USA patients and the lack of an early ticagrelor benefit in the overall invasive PLATO cohort reported by the FDA. The discrepancy between PLATO-A and PLATO-P is obvious and lacks a reasonable explanation: platelet activity and coronary flow are generally inversely related, as consistently shown for other antiplatelet regimens, and should be particularly matched when assessed in the frame of the same trial. PMID:24457905

Serebruany, Victor L

2014-01-01

367

Effectiveness of continuous glucose monitoring during diabetic pregnancy (GlucoMOMS trial; a randomised controlled trial  

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Full Text Available Abstract Background Hyperglycemia in pregnancy is associated with poor perinatal outcome. Even if pregnant women with diabetes are monitored according to current guidelines, they do much worse than their normoglycaemic counterparts, marked by increased risks of pre-eclampsia, macrosomia, and caesarean section amongst others. Continuous Glucose Monitoring (CGM is a new method providing detailed information on daily fluctuations, used to optimize glucose control. Whether this tool improves pregnancy outcome remains unclear. In the present protocol, we aim to assess the effect of CGM use in diabetic pregnancies on pregnancy outcome. Methods/design The GlucoMOMS trial is a multicenter open label randomized clinical trial with a decision and cost-effectiveness study alongside. Pregnant women aged 18 and over with either diabetes mellitus type 1 or 2 on insulin therapy or with gestational diabetes requiring insulin therapy before 30 weeks of gestation will be asked to participate. Consenting women will be randomly allocated to either usual care or complementary CGM. All women will determine their glycaemic control by self-monitoring of blood glucose levels and HbA1c. In addition, women allocated to CGM will use it for 5–7 days every six weeks. Based on their CGM profiles they receive dietary advice and insulin therapy adjustments if necessary. The primary outcome measure is rate of macrosomia, defined as a birth weight above the 90th centile. Secondary outcome measures will be birth weight, composite neonatal morbidity, maternal outcome and costs. The analyses will be according to the intention to treat principle. Discussion With this trial we aim at clarifying whether the CGM improves pregnancy outcome when used during diabetic pregnancies. Trial registration Nederlands Trial Register: NTR2996

Voormolen Daphne N

2012-12-01

368

Maintenance Chemotherapy in Ovarian Cancer: A Trial-Sequential Analysis  

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Full Text Available In patients with epithelian ovarian cancer who have achieved remission after initial surgery and induction chemotherapy, the role of maintenance chemotherapy is controversial. We carried out a trial-sequential analysis that included 4 randomised controlled trials. The end-point was progression at 3 years while the boundary for non-inferiority was set at ±20% in risk ratio. The results of our trial-sequential analysis indicated the futility of maintenance chemotherapy, i.e. proof of no effectiveness. Consequently, no further trials of this type should be performed to assess the effectiveness of this intervention in this clinical condition.  

Andrea Messori

2013-08-01

369

The problem of truth in war crimes trials  

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Full Text Available The author discusses the relationship between the truth and criminal trial in general, with a special focus on war crimes trials and their consequences for the fragile processes of consolidation of violated collective identities in post-conflict states. The authors challenge the idea that a criminal trial is a search for the truth, and present a philosophical argument to the effect that the trial is in fact an event conforming to the model of what the author calls “quasi-epistemological games”, rather than the model of an epistemological engine. The purpose of the trial is quasi-epistemological, because the model of an epistemological engine entails that the trial is primarily a search for the truth, while this is not the case with criminal trials in general, and especially with war crimes trials. He argues that, while the criminal trial readily invites the truth of the events if it is discovered, it can be and often is both valid and valuable regardless of whether “the truth, the full truth, and nothing but the truth” is discovered in its course.

Fati? Aleksandar

2012-01-01

370

Open-access clinical trial registries: the Italian scenario  

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Full Text Available Abstract Background Citizens, patients and their representatives are increasingly insisting on working with health professionals to organize and discuss research protocols. The International Committee of Medical Journal Editors recommended setting up a public clinical trial registry where anyone can find key information about a trial. Around the world, governments have, in fact, now begun to legislate mandatory disclosure of all clinical trials. The aims of the present survey were to assess the availability of clinical trial registries for Italian citizens and to examine the transparency of the data items reported. Methods The availability of open-access clinical trial registries was surveyed on a sample of 182 websites, including research institutes and centers of excellence (IRCCS-teaching hospitals, hospitals and associations. For each registry we downloaded a sample of two trials to assess the correspondence of the data items reported. Results from the Italian and international registries were compared. Results Fifteen percent of the sample had an open-access registry of clinical trials. Comparison of the data items available, in terms of completeness and transparency, from institutional and international registries indicated wide variability. Conclusions Italian citizens, patients and their associations have scant access to local registries of clinical trials, and international registries are generally more informative. On the European level, advocacy and lobby actions are needed among citizens and patients to boost the diffusion of open-access clinical trial registries without language barriers, thereby facilitating participation, access to information, and the coordination of clinical research.

Mosconi Paola

2012-10-01

371

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

2010-11-09

372

Effect of the Mediterranean diet on blood pressure in the PREDIMED trial: results from a randomized controlled trial  

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Background: Hypertension can be prevented by adopting healthy dietary patterns. Our aim was to assess the 4-year effect on blood pressure (BP) control of a randomized feeding trial promoting the traditional Mediterranean dietary pattern. Methods: The PREDIMED primary prevention trial is a randomized, single-blinded, controlled trial conducted in Spanish primary healthcare centers. We recruited 7,447 men (aged 55 to 80 years) and women (aged 60 to 80 years) who had high risk for cardiovascular...

Toledo, Estefania; Hu, Frank B.; Estruch, Ramon; Buil-cosiales, Pilar; Corella, Dolores; Salas-salvado?, Jordi; Covas, M. Isabel; Aro?s, Fernando; Go?mez-gracia, Enrique; Fiol, Miquel; Lapetra, Jose; Serra-majem, Luis; Pinto, Xavier; Lamuela-ravento?s, Rosa M.; Saez, Guillermo

2013-01-01

373

Regulatory Aspects of Clinical Trials in Iran: Third Year Report of Clinical Trial Committee in Food and Drug Organization  

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Background: Clinical Trial Committee (CTC) has been established in Food and Drug Organization (FDO), in 2003 to assure efficacy and safety of all types of medicinal products which are meant to be registered in Iran Drug List and/or obtain market authorization.Methods: All clinical trial files, meeting minutes and databases in CTC secretariat in FDO were reviewed. Relevant information and data extracted, analyzed and reported.Results: Total number of clinical trial (CT) files received by CTC, ...

2013-01-01

374

A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: Trial protocol  

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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...

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

375

Anticholinergic Versus Botulinum Toxin A Comparison Trial for the Treatment of Bothersome Urge Urinary Incontinence: ABC Trial  

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This trial compares the change in urgency urinary incontinence episodes over 6 months, tolerability and cost effectiveness between women receiving daily anticholinergic therapy plus a single intra-detrusor injection of saline versus a single intra-detrusor injection of 100 unit of botulinum toxin A plus daily oral placebo tablets. We present the rationale and design of a randomized controlled trial, Anticholinergic versus Botulinum Toxin, Comparison Trial for the Treatment of Bothersome Urge ...

Visco, Anthony G.; Brubaker, Linda; Richter, Holly E.; Nygaard, Ingrid; Paraiso, Marie Fidela; Menefee, Shawn A.; Schaffer, Joseph; Wei, John; Chai, Toby; Janz, Nancy; Spino, Cathie; Meikle, Susan

2012-01-01

376

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

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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 (ST...

Briel Matthias; Lane Melanie; Montori Victor M; Bassler Dirk; Glasziou Paul; Malaga German; Akl Elie A; Ferreira-Gonzalez Ignacio; Alonso-Coello Pablo; Urrutia Gerard; Kunz Regina; Culebro Carolina; da Silva Suzana; Flynn David N; Elamin Mohamed B

2009-01-01

377

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

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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.

Zhao-Xiang BIAN

2006-03-01

378

Trial-to-trial carry-over of item- and relational-information in auditory short-term memory  

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Using a short-term recognition memory task we evaluated the carry-over across trials of two types of auditory information: the characteristics of individual study sounds (item information), and the relationships between the study sounds (relational information). On each trial, subjects heard two successive broadband study sounds and then decided whether a subsequently presented probe sound had been in the study set. On some trials, the probe item's similarity to stimuli presented on the prece...

2009-01-01

379

Impact of cyclooxygenase inhibitors in the women's health initiative hormone trials: secondary analysis of a randomized trial  

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Objectives: We evaluated the hypothesis that cyclooxygenase (COX) inhibitor use might have counteracted a beneficial effect of postmenopausal hormone therapy, and account for the absence of cardioprotection in the Women's Health Initiative hormone trials. Estrogen increases COX expression, and inhibitors of COX such as nonsteroidal anti-inflammatory agents appear to increase coronary risk, raising the possibility of a clinically important interaction in the trials. Design: The hormone trials ...

Hsia, Judith; Kuller, Lewis; Pettinger, Mary; Choe, John H.; Limacher, Marian; Oberman, Albert; Ockene, Judith; O Sullivan, Mary Jo; Robinson, Jennifer G.; Manson, Joann Elisabeth; Langer, Robert D.

2006-01-01

380

DeLLITE Depression in late life: an intervention trial of exercise. Design and recruitment of a randomised controlled trial  

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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 s...

Kerse Ngaire; Falloon Karen; Moyes Simon A; Hayman Karen J; Dowell Tony; Kolt Gregory S; Raina, Elley C.; Hatcher Simon; Peri Kathy; Keeling Sally; Robinson Elizabeth; Parsons John; Wiles Janine; Arroll Bruce

2008-01-01

 
 
 
 
381

Treatment success in pragmatic randomised controlled trials: a review of trials funded by the UK Health Technology Assessment programme  

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Full Text Available Abstract Background Previous research reviewed treatment success and whether the collective uncertainty principle is met in RCTs in the US National Cancer Institute portfolio. This paper classifies clinical trials funded by the UK HTA programme by results using the method applied to the US Cancer Institute trials, and compares the two portfolios. Methods Data on all completed randomised controlled trials funded by the HTA programme 1993-2008 were extracted. Each trial's primary results was classified into six categories; 1 statistically significant in favour of the new treatment, 2 statistically significant in favour of the control treatment 3 true negative, 4 truly inconclusive, 5 inconclusive in favour of new treatment or 6 inconclusive in favour of control treatment. Trials were classified by comparing the 95% confidence interval for the difference in primary outcome to the difference specified in the sample size calculation. The results were compared with Djulbegovic's analysis of NCI trials. Results Data from 51 superiority trials were included, involving over 48,000 participants and a range of diseases and interventions. 85 primary comparisons were available because some trials had more than two randomised arms or had several primary outcomes. The new treatment had superior results (whether significant or not in 61% of the comparisons (52/85 95% CI 49.9% to 71.6%. The results were conclusive in 46% of the comparisons (19% statistically significant in favour of the new treatment, 5% statistically significant in favour of the control and 22% true negative. The results were classified as truly inconclusive (i.e. failed to answer the question asked for 24% of comparisons (20/85. HTA trials included fewer truly inconclusive and statistically significant results and more results rated as true negative than NCI trials. Conclusions The pattern of results in HTA trials is similar to that of the National Cancer Institute portfolio. Differences that existed were plausible given the differences in the types of trials -HTA trials are more pragmatic. The results indicate HTA trials are compatible with equipoise. This classification usefully summarises the results from clinical trials and enables comparisons of different portfolios of trials.

Raftery James

2011-05-01

382

RReACT goes global: Perils and pitfalls of constructing a global open-access database of registered analgesic clinical trials and trial results.  

Science.gov (United States)

Eliminating publication bias requires ensuring public awareness of studies and access to results. Clinical trial registries provide basic trial information, but access to unbiased trial results is inadequate. Nearly all studies of trial registration and results reporting have been limited to the ClinicalTrials.gov registry. We analyzed trial registration, registry functionality, cross-registry harmonization, and results reporting on all 15 primary registries in the World Health Organization International Clinical Trials Registry Platform (ICTRP) for postherpetic neuralgia, painful diabetic neuropathy, and fibromyalgia. A total of 447 unique trials were identified, with 86 trials listed on more than one registry. A comprehensive search algorithm was used to find trial results in the peer-reviewed literature and the grey literature. Creating a global database of registered trials and trial results proved surprisingly difficult for several reasons: 1) ICTRP does not reliably identify trials listed on multiple registries, manual searches are necessary; 2) Searching ICTRP yields different results than searching individual registries; 3) Outcome measure descriptions for multiply registered trials vary between registries; 4) Registry-publication pairings are often inaccurate or incomplete; 5) Grey literature results are not permanent. Overall, only 46% of all trials had results available. Trials registered on ClinicalTrials.gov were significantly more likely to have results (52% vs 18%, Pmeeting abstracts and peer-reviewed papers, specific strategies are offered to facilitate identifying multiply registered studies and ensuring accurate pairing of results and publications. PMID:24726925

Munch, Troels; Dufka, Faustine L; Greene, Kaitlin; Smith, Shannon M; Dworkin, Robert H; Rowbotham, Michael C

2014-07-01

383

TEMPSC trials in the Northumberland Strait  

Energy Technology Data Exchange (ETDEWEB)

The number of offshore projects and shipping operations in ice-covered waters is steadily increasing. In addition to helicopter evacuation, ships and offshore platforms must be equipped with evacuation systems such as the Totally Enclosed, Motor Propelled Survival Craft (TEMPSC) of either davit-launched or free-fall types. BMT Fleet Technology Limited (BMT FTL) conducted a study to test a TEMPSC in ice conditions and to provide a detailed analysis of its survivability. The core of the project was the deployment of an instrumented TEMPSC into the Northumberland Strait between the mainland of Canada and Prince Edward Island during March 2003. This paper presented the background to the project and its objectives. It provided a description of the TEMPSC used in the trials, and of the instrumentation that was fitted to record its performance. It described the trials that were planned, and the difference with those that were actually undertaken. A summary of key findings and their safety implications were presented. The overall objective was to provide a baseline picture of some capabilities of a standard, SOLAS-approved TEMPSC in ice operations. The trials addressed adequacy of hull strengthening to resist pressure and impact loads; life support; and, propulsor and steering system vulnerability. Although the data collected was specific to the Schat-Harding KISS design and to the ice conditions of the Northumberland Strait, many of the findings can be applied to other craft and locations. The study showed that the TEMPSC was not held and crushed by pressure. Ice thickness was found to be a less directly important factor in survivability. The TEMPSC design was more capable than expected of surviving prolonged exposure to ice. The flexibility of the structure helped distribute and limit many load peaks, and the hull ultimate strength is sufficient to resist loads of the magnitude required to displace the hull globally. It was determined that the risk level for evacuation into ice-infested waters depends on the length of exposure prior to rescue and on the probability of wind and tidal conditions. Although survivors in ice-covered waters in a standard TEMPSC are unlikely to freeze, they would find the experience uncomfortable due to condensation, motion, and noise. 1 tab., 9 figs.

Kendrick, A.; Igloliorte, G.; Steele, M. [BMT Fleet Technology Ltd., Kanata (Canada)

2006-11-15

384

Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial  

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Full Text Available Abstract Background Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE. The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group. Methods/Design A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ? 25.0 kg/m2 will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months. Discussion Evidence-based approaches to the high burden of obesity and cardiovascular disease risk in person with serious mental illness are urgently needed. The ACHIEVE Trial is tailored to persons with serious mental illness in community settings. This multi-site randomized clinical trial will provide a rigorous evaluation of a practical behavioral intervention designed to accomplish and sustain weight loss in persons with serious mental illness. Trial Registration Clinical Trials.gov NCT00902694

Guallar Eliseo

2010-12-01

385

The CORONIS Trial. International study of caesarean section surgical techniques: a randomised fractional, factorial trial  

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Full Text Available Abstract Background Caesarean section is one of the most commonly performed operations on women throughout the world. Rates have increased in recent years – about 20–25% in many developed countries. Rates in other parts of the world vary widely. A variety of surgical techniques for all elements of the caesarean section operation are in use. Many have not yet been rigorously evaluated in randomised controlled trials, and it is not known whether any are associated with better outcomes for women and babies. Because huge numbers of women undergo caesarean section, even small differences in post-operative morbidity rates between techniques could translate into improved health for substantial numbers of women, and significant cost savings. Design CORONIS is a multicentre, fractional, factorial randomised controlled trial and will be conducted in centres in Argentina, Ghana, India, Kenya, Pakistan and Sudan. Women are eligible if they are undergoing their first or second caesarean section through a transverse abdominal incision. Five comparisons will be carried out in one trial, using a 2 × 2 × 2 × 2 × 2 fractional factorial design. This design has rarely been used, but is appropriate for the evaluation of several procedures which will be used together in clinical practice. The interventions are: • Blunt versus sharp abdominal entry • Exteriorisation of the uterus for repair versus intra-abdominal repair • Single versus double layer closure of the uterus • Closure versus non-closure of the peritoneum (pelvic and parietal • Chromic catgut versus Polyglactin-910 for uterine repair The primary outcome is death or maternal infectious morbidity (one or more of the following: antibiotic use for maternal febrile morbidity during postnatal hospital stay, antibiotic use for endometritis, wound infection or peritonitis or further operative procedures; or blood transfusion. The sample size required is 15,000 women in total; at least 7,586 women in each comparison. Discussion Improvements in health from optimising caesarean section techniques are likely to be more significant in developing countries, because the rates of postoperative morbidity in these countries tend to be higher. More women could therefore benefit from improvements in techniques. Trial registration The CORONIS Trial is registered in the Current Controlled Trials registry. ISCRTN31089967.

2007-10-01

386

Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial).  

Science.gov (United States)

BACKGROUND: More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The situation on university campuses is even more startling, with as many as 1 in 4 female students being victims of rape or attempted rape. The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program can reduce the incidence of sexual assault among university-attending women, when compared to current university practice of providing informational brochures. METHODS: The trial will evaluate a theoretically and empirically sound four-unit, 12-hour education program that has been demonstrated in pilot studies to have short-term efficacy. Three of the four units provide information, skills, and practice aimed at decreasing the time needed for women to assess situations with elevated risk of acquaintance sexual assault as dangerous and to take action, reducing emotional obstacles to taking action, and increasing the use of the most effective methods of verbal and physical self-defense. The fourth unit focuses on facilitating a stronger positive sexuality from which women may resist sexual coercion by male intimates more successfully. The trial will extend the pilot evaluations by expanding the participant pool and examining the long term efficacy of the program. A total of 1716 first-year female students (age 17 to 24 years) from three Canadian universities will be enrolled. The primary outcome is completed sexual assault, measured by The Sexual Experiences Survey - Short Form Victimization instrument. Secondary outcomes include changes in knowledge, attitudes, and skills related to the process of sexual assault resistance. Outcomes will be measured at baseline, 1 week, 6, 12, 18, and 24 months. DISCUSSION: The results of the trial will be used to produce a maximally effective sexual assault resistance education program that can be adopted by universities, to assess whether aspects of the program need to be strengthened, and also to indicate how long the effects of the program last and at which point in time refresher sessions may be necessary.Trial registration: ClinicalTrials.gov NCT01338428. PMID:23702221

Senn, Charlene Y; Eliasziw, Misha; Barata, Paula C; Thurston, Wilfreda E; Newby-Clark, Ian R; Radtke, H Lorraine; Hobden, Karen L

2013-05-23

387

Clinical trials in locally advanced breast cancer  

International Nuclear Information System (INIS)

Survival after treatment of locally advanced breast cancer is poor and resembles that for untreated breast cancer. Although retrospective comparisons have suggested that the addition of systemic treatment might be beneficial, a literature survey of the controlled clinical trials failed to show consistent survival benefits of any treatment modality. The local control, or time to local progression, on the other hand seems to be improved by increasing the dose of radiotherapy, or by the addition of endocrine or cytostatic treatment. Further studies should be undertaken to find better means to subdivide patients in different treatment groups. Since the present treatment modalities are unlikely to improve survival more than marginally, clinical studies are necessary to search for the best palliative treatment, until experimental work provides us with better treatment tools. (orig.)

1990-01-01

388

Clinical trials of bisphosphonates in multiple myeloma.  

Science.gov (United States)

More than 80% of patients with multiple myeloma (MM) have osteolytic bone disease, which increases the risk of skeletal-related events (SREs) such as pathologic fracture, spinal cord compression, and the need for radiotherapy or surgery. Bone disease is primarily due to increased osteoclastic activity and impaired osteoblast activity. Bisphosphonates are pyrophosphate analogues with high bone affinity that can inhibit osteoclastic activity. Pamidronate and zoledronic acid are the most commonly used bisphosphonates in multiple myeloma. Other agents include ibandronate and clodronate. Bisphosphonates are associated with several adverse events, such as renal toxicity and osteonecrosis of the jaw. The optimal duration of bisphosphonate therapy has yet to be determined. Clinical trials are investigating tailored approaches to management based on treatment-related changes in levels of bone resorption markers. PMID:23073123

Mahindra, Anuj; Pozzi, Samantha; Raje, Noopur

2012-09-01

389

The penumbra of randomized control trials.  

Science.gov (United States)

Pre-occupation with randomized control trials as the basis of evidence-based medicine has increasingly shadowed other study designs over the last half a century. These include surveys, case-control studies, and case-cohort studies. They have the potential to overcome several ethical and cost constraints, but depend on the embedding of research in routine practice, emphasis on relevant but limited, accurate, and complete data, harnessing of information technology for this purpose, and epidemiological and statistical literacy among clinicians. Only then will it be possible to nurture and network research-oriented practices by therapeutic areas. Given these, the alternative study designs can pave the way to regulatory reforms that will ultimately benefit the discoverers, approvers and users of health-care tools. PMID:24010055

Nanivadekar, Arun S

2013-07-01

390

Synthesizing Results from Trial State Assessment  

Science.gov (United States)

Using data collected under the Trial State Assessment (TSA) of the National Assessment of Educational Progress (NAEP), this article describes and illustrates a two-stage statistical model for investigating state-to-state variation in mathematics achievement. At the first stage, within each state, a two-level hierarchical linear model is estimated via maximum likelihood. At the second stage, results are combined across states using Bayesian estimation implemented via the Gibbs sampler. The results reveal considerable state-to-state heterogeneity in mathematics proficiency, but most heterogeneity is explainable on the basis of covariates defined on students, teachers, and schools. The findings suggest that interest in state comparisons might productively focus on state differences in mean proficiency. The analytical approach can be applied in other cases where data are dense at the lower level of a hierarchy but thin at the higher level.

Raudenbush, S. W.; Fotiu, R. P.; Cheong, Y. F.

2010-10-01

391

The Svalbard shoreline oilspill field trials  

Energy Technology Data Exchange (ETDEWEB)

The 1997 Svalbard shoreline oil spill field experiment was conducted to quantify the effectiveness of different in situ shoreline treatment options that are commonly used to accelerate natural oil removal processes on mixed coarse sediment beaches. Three experimental sites were chosen near the mining town of Sveagruva on Spitsbergen, the largest island in Svalbard, Norway. 5,500 litres of an intermediate fuel oil, was applied directly to a 3 m wide area of the upper intertidal zone sediment surface in a controlled and uniform manner. Full scale treatments began one week after oiling to allow for wave and tidal washing and stabilization of the oiled zone. Five treatment options were used: (1) sediment relocation, (2) tilling (or aeration); (3) bioremediation, (4) tilling combined with bioremediation, and (5) natural recovery. The sediment was treated in the same way as in an actual response operation. The trials were successful from both an operational and experimental point of view. 14 refs., 2 tabs., 9 figs.

Sergy, G.A. [Environment Canada, Edmonton, AB (Canada); Guenette, C.C. [SINTEF Applied Chemistry Environmental Engineering, Trondheim (Norway); Owens, E.H. [Owens Coastal Consultants, Bainbridge Island, WA (United States); Prince, R.C. [Exxon Research and Engineering Co., Annandale, NJ (United States)

1998-09-01

392

Psychiatry on trial: the Norway 2011 massacre.  

Science.gov (United States)

On July 22, 2011, Anders Breivik, a Norwegian citizen, detonated a fertilizer bomb near government buildings in Oslo, killing eight people, and then proceeded to a nearby island where the Labor Party was holding a youth camp. There, he killed 69 people before being arrested. Just before these events, he posted a "compendium" on the Web explaining his actions and encouraging others to do likewise. Much of the ensuing media coverage and trial focused on whether he was sane and whether he had a psychiatric diagnosis. One team of court-appointed psychiatrists found him to be psychotic with a diagnosis of paranoid schizophrenia and legally insane. A second team found him neither psychotic nor schizophrenic and, thus, legally sane. Their contrary opinions were not reconciled by observing his behavior in court. We discuss why experienced psychiatrists reached such fundamentally opposing diagnostic conclusions about a "home-grown" terrorist holding extreme political views. PMID:24566502

Roth, Walton T; Dager, Stephen R

2014-03-01

393

News from the Library: Knovel trial period  

CERN Multimedia

Knovel is a Web-based database integrating technical information with analytical and search tools. It is specifically aimed at the engineering community, offering validated content derived from the most trusted sources.   Knovel combines the functionalities of an e-book platform and a search engine querying a plurality of online databases. These functionalities are complemented by analytical tools that permit the extraction and manipulation of data from e-book content. Knovel?s tools - including its interactive tables and graphs - not only help users to find information hidden in complex graphs, equations and tables quickly, but also to analyse and manipulate data as easily as sorting a spreadsheet. Using either simple keywords or full Boolean queries, Knovel searches across different data sets to find the information engineers need, however deeply it may be buried. For more information please visit why.knovel.com and the corresponding Youtube channel. A trial period of Knovel for the whol...

CERN Library

2014-01-01

394

European user trial of paging by satellite  

Science.gov (United States)

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

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

395

Diagnostic trials using CT scanning in urology  

International Nuclear Information System (INIS)

We attempted various new diagnostic trials using CT scanning. The results obtained were: 1) Twelve transplanted kidneys were scanned after bolus contrast administration. Enhancing indices (EI) calculated from the formula: EI = (CT numbers 10 minutes after injection) / (CT numbers before injection) were inversely proportional to serum creatinine. 2) CT guided puncture was successful in percutaneous nephrostomy in 3 of 5 cases of obstructive uropathy and in 5 cases of renal cystic disease. 3) Emergent CT scans were diagnostically useful in 9 cases of urinary tract injury to indicate the surgery. 4) CT scans after perivesical pneumography in 5 cases of the vesical tumor diclosed the perivesical invasion. 5) Cervical CT scans was performed as localization study of parathyroid gland in 3 cases of secondary hyperparathyroidism in chronic renal insufficiency. More than 1400 mg of parathyroid gland in the neck was clearly visualized on cervical CT scans. (author)

1981-01-01

396

Inclusion of women in clinical trials  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract There is increasing concern among many in the medical arena about the extent to which the effects of treatment, either good or bad, apply to specific subgroups of individuals. Women comprise one of the most frequently considered 'subgroups' of patients. In the 1980s, much political attention was focused on concerns about equity in the research enterprise. In this paper, we briefly describe the statutory approaches to achieving equity in research, beginning with The NIH Revitalization Act of 1993. We go on to describe clinical, methodological and political factors affecting these discussions. We conclude that the controversy over the inclusion of women in clinical trials probably stems, in part, from theoretical concerns about gender differences in treatment effects and, in part, by legitimate fears of exposing fetuses to investigational drugs. However, we believe that the broader issue centres on biological factors, possibly defined by genes or gene expression, that may directly or indirectly modify the effect of specific treatments on specific individuals. A growing concern of physicians, regulators, healthcare policy makers and patients is the extent to which the effects of treatment, both good and bad, apply to specific subgroups. Do results of clinical trials apply consistently and equally across all clinically meaningful subclasses of patients enrolled in the studies? Can the results of those studies be extrapolated to patients or types of patients who did not participate in the original research? Reliable data on these issues are rarely available at the time of drug approval and are more difficult to generate once the drug is on the market and readily available.

Ellenberg Susan S

2009-10-01

397

Trial watch: DNA vaccines for cancer therapy.  

Science.gov (United States)

The foundation of modern vaccinology dates back to the 1790s, when the English physician Edward Jenner uncovered the tremendous medical potential of prophylactic vaccination. Jenner's work ignited a wave of nationwide vaccination campaigns abating the incidence of multiple life-threatening infectious diseases and culminating with the eradication of natural smallpox virus, which was definitively certified by the WHO in 1980. The possibility of using vaccines against cancer was first proposed at the end of the 19th century by Paul Ehrlich and William Coley. However, it was not until the 1990s that such a hypothesis began to be intensively investigated, following the realization that the immune system is not completely unresponsive to tumors and that neoplastic cells express immunogenic tumor-associated antigens (TAAs). Nowadays, anticancer vaccines are rapidly moving from the bench to the bedside, and a few prophylactic and therapeutic preparations have already been approved by FDA for use in humans. In this setting, one interesting approach is constituted by DNA vaccines, i.e., TAA-encoding circularized DNA constructs, often of bacterial origin, that are delivered to patients as such or by means of specific vectors, including (but not limited to) liposomal preparations, nanoparticles, bacteria and viruses. The administration of DNA vaccines is most often performed via the intramuscular or subcutaneous route and is expected to cause (1) the endogenous synthesis of the TAA by myocytes and/or resident antigen-presenting cells; (2) the presentation of TAA-derived peptides on the cell surface, in association with MHC class I molecules; and (3) the activation of potentially therapeutic tumor-specific immune responses. In this Trial Watch, we will summarize the results of recent clinical trials that have evaluated/are evaluating DNA vaccines as therapeutic interventions against cancer. PMID:23734328

Senovilla, Laura; Vacchelli, Erika; Garcia, Pauline; Eggermont, Alexander; Fridman, Wolf Hervé; Galon, Jérôme; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

2013-04-01

398

Rationale for the tinnitus retraining therapy trial  

Science.gov (United States)

The Tinnitus Retraining Therapy Trial (TRTT) is a National Institutes of Health-sponsored, multi-centered, placebo-controlled, randomized trial evaluating the efficacy of tinnitus retraining therapy (TRT) and its component parts, directive counseling and sound therapy, as treatments for subjective debilitating tinnitus in the military. The TRTT will enroll 228 individuals at an allocation ratio of 1:1:1 to: (1) directive counseling and sound therapy using conventional sound generators; (2) directive counseling and placebo sound generators; or (3) standard of care as administered in the military. Study centers include a Study Chair’s Office, a Data Coordinating Center, and six Military Clinical Centers with treatment and data collection standardized across all clinics. The primary outcome is change in Tinnitus Questionnaire (TQ) score assessed longitudinally at 3, 6, 12, and 18-month follow-up visits. Secondary outcomes include: Change in TQ sub-scales, Tinnitus Handicap Inventory, Tinnitus Functional Index, and TRT interview visual analog scale; audiometric and psychoacoustic measures; and change in quality of life. The TRTT will evaluate TRT efficacy by comparing TRT (directive counseling and conventional sound generators) with standard of care; directive counseling by comparing directive counseling plus placebo sound generators versus standard of care; and sound therapy by comparing conventional versus placebo sound generators. We hypothesize that full TRT will be more efficacious than standard of care, directive counseling and placebo sound generators more efficacious than standard of care, and conventional more efficacious than placebo sound generators in habituating the tinnitus awareness, annoyance, and impact on the study participant’s life.

Formby, Craig; Scherer, Roberta

2013-01-01

399

Rationale for the tinnitus retraining therapy trial.  

Science.gov (United States)

The Tinnitus Retraining Therapy Trial (TRTT) is a National Institutes of Health-sponsored, multi-centered, placebo-controlled, randomized trial evaluating the efficacy of tinnitus retraining therapy (TRT) and its component parts, directive counseling and sound therapy, as treatments for subjective debilitating tinnitus in the military. The TRTT will enroll 228 individuals at an allocation ratio of 1:1:1 to: (1) directive counseling and sound therapy using conventional sound generators; (2) directive counseling and placebo sound generators; or (3) standard of care as administered in the military. Study centers include a Study Chair's Office, a Data Coordinating Center, and six Military Clinical Centers with treatment and data collection standardized across all clinics. The primary outcome is change in Tinnitus Questionnaire (TQ) score assessed longitudinally at 3, 6, 12, and 18-month follow-up visits. Secondary outcomes include: Change in TQ sub-scales, Tinnitus Handicap Inventory, Tinnitus Functional Index, and TRT interview visual analog scale; audiometric and psychoacoustic measures; and change in quality of life. The TRTT will evaluate TRT efficacy by comparing TRT (directive counseling and conventional sound generators) with standard of care; directive counseling by comparing directive counseling plus placebo sound generators versus standard of care; and sound therapy by comparing conventional versus placebo sound generators. We hypothesize that full TRT will be more efficacious than standard of care, directive counseling and placebo sound generators more efficacious than standard of care, and conventional more efficacious than placebo sound generators in habituating the tinnitus awareness, annoyance, and impact on the study participant's life. PMID:23571304

Formby, Craig; Scherer, Roberta

2013-01-01

400

The Postoperative Pain Assessment Skills pilot trial  

Science.gov (United States)

BACKGROUND/OBJECTIVES: Pain-related misbeliefs among health care professionals (HCPs) are common and contribute to ineffective postoperative pain assessment. While standardized patients (SPs) have been effectively used to improve HCPs’ assessment skills, not all centres have SP programs. The present equivalence randomized controlled pilot trial examined the efficacy of an alternative simulation method – deteriorating patient-based simulation (DPS) – versus SPs for improving HCPs’ pain knowledge and assessment skills. METHODS: Seventy-two HCPs were randomly assigned to a 3 h SP or DPS simulation intervention. Measures were recorded at baseline, immediate postintervention and two months postintervention. The primary outcome was HCPs’ pain assessment performance as measured by the postoperative Pain Assessment Skills Tool (PAST). Secondary outcomes included HCPs knowledge of pain-related misbeliefs, and perceived satisfaction and quality of the simulation. These outcomes were measured by the Pain Beliefs Scale (PBS), the Satisfaction with Simulated Learning Scale (SSLS) and the Simulation Design Scale (SDS), respectively. Student’s t tests were used to test for overall group differences in postintervention PAST, SSLS and SDS scores. One-way analysis of covariance tested for overall group differences in PBS scores. RESULTS: DPS and SP groups did not differ on post-test PAST, SSLS or SDS scores. Knowledge of pain-related misbeliefs was also similar between groups. CONCLUSIONS: These pilot data suggest that DPS is an effective simulation alternative for HCPs’ education on postoperative pain assessment, with improvements in performance and knowledge comparable with SP-based simulation. An equivalence trial to examine the effectiveness of deteriorating patient-based simulation versus standardized patients is warranted.

McGillion, Michael; Dubrowski, Adam; Stremler, Robyn; Watt-Watson, Judy; Campbell, Fiona; McCartney, Colin; Victor, J Charles; Wiseman, Jeffrey; Snell, Linda; Costello, Judy; Robb, Anja; Nelson, Sioban; Stinson, Jennifer; Hunter, Judith; Dao, Thuan; Promislow, Sara; McNaughton, Nancy; White, Scott; Shobbrook, Cindy; Jeffs, Lianne; Mauch, Kianda; Leegaard, Marit; Beattie, W Scott; Schreiber, Martin; Silver, Ivan

2011-01-01

 
 
 
 
401

Gateways to Clinical Trials. June 2002.  

Science.gov (United States)

Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abacavir sulfate, abarelix, abciximab, alicaforsen sodium, almotriptan, alteplase, amlodipine, amoxicillin trihydrate, amprenavir, argatroban monohydrate, aspirin, atorvastatin calcium, azathioprine; Baclofen, benidipine hydrochloride, benserazide, BMS-214662, bosentan, botulinum toxin type B; Candesartan cilexetil, carbamazepine, carbidopa, carboplatin, ceftriaxone sodium, celecoxib, cetirizine hydrochloride, clarithromycin, clavulanate potassium, clopidogrel hydrogensulfate, clozapine, CPI-1189, cyclophosphamide, cytarabine; Darbepoetin alfa, denileukin diftitox, dexamethasone, dipyridamole, droperidol, DW-166HC; Ebastine, efalizumab, efavirenz, eletriptan, enalapril maleate, enfuvirtide, enoxaparin sodium, enrasentan, entacapone, epoetin, eprosartan mesilate, etanercept, etoricoxib; Fenofibratefexofenadine hydrochloride, filgrastim, fludarabine phosphate, fluoxetine hydrochloride fluvoxamine maleate, frovatriptan, furosemide; Gabapentin, galantamine hydrobromide, gatifloxacin, gefitinib, ghrelin (human), glatiramer acetate; Haloperidol; Ibuprofen, ibuprofen, guaiacol ester, idarubicin hydrochloride, imipramine hydrochloride, imiquimod, interferon beta, interferon beta-1a, interferon beta-1b, interferon omega, irbesartan, itraconazole; Ketorolac, ketorolac tromethamine; Lamifiban, lamotrigine, lanoteplase, lansoprazole, leflunomide, leuprorelin acetate, levetiracetam, levocetirizine, levodopa, lisinopril, loratadine; Manidipine, methylprednisolone, metronidazole, mirtazapine, mizolastine, modafinil, morphine sulfate; Naproxen sodium, naratriptan hydrochloride, nifedipine, NSC-683864; Ofloxacin, olanzapine, omalizumab, omapatrilat, ondansetron hydrochloride, oxcarbazepine; Paclitaxel, parecoxib sodium, paroxetine hydrochloride, phenytoin sodium, pimecrolimus, pramipexole hydrochloride, pravastatin, prednisone, pregabalin; Quetiapine fumarate; Ranitidine hydrochloride, rasburicase, ritonavir, rivastigmine tartrate, rizatriptan benzoate, rofecoxib; Saquinavir mesilate, sertraline, sildenafil citrate, simvastatin, sumatriptan succinate; Tacrolimus, tiagabine hydrochloride, ticlopidine hydrochloride, tirofiban hydrochloride, tolvaptan, topiramate, tretinoin; Valproic acid, valsartan, venlafaxine hydrochloride, verapamil; Warfarin sodium; Ximelagatran; Zanamivir, ziconotide, zolmitriptan, zonisamide. PMID:12168506

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

2002-06-01

402

rAAV human trial experience.  

Science.gov (United States)

Recombinant AAV vectors have been used in clinical trials since the mid-1990s, with over 300 subjects enrolled in studies. Although there are not yet licensed AAV products, there are several clear examples of clinical efficacy, and recombinant AAV vectors have a strong safety record after administration both locally and systemically. This chapter provides a review of two types of studies that have shown efficacy, including studies for Leber's congenital amaurosis, a hereditary retinal degenerative disorder in which subretinal administration of AAV has shown efficacy in terms of improvement in multiple measures of visual/retinal function; and of Parkinson's disease which has also shown improvement in clinical and imaging studies after gene transfer to the CNS. The chapter also provides a detailed review of the results of studies of gene therapy for hemophilia, in which short-term efficacy was achieved, but expression of the donated gene failed to persist, likely due to an immune response to the vector. Safety issues relating to AAV-mediated gene transfer are discussed, including a detailed review of the single death to have occurred in an AAV gene therapy trial (likely unrelated to the AAV vector), and of issues related to integration and insertional mutagenesis, risk of germline transmission, and risks related to immune responses to either vector or transgene product. Finally, protocols for determining the presence of vector DNA in body fluids using real-time quantitative PCR, and for isolating, cryopreserving, and testing peripheral blood mononuclear cells for interferon-? (IFN-?) responses to capsid are described in detail. PMID:22034041

High, Katherine A; Aubourg, Patrick

2011-01-01

403

Review on clinical trials of targeted treatments in malignant mesothelioma  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Purpose Malignant mesothelioma (MM) is an aggressive tumor of the serosal surfaces with a poor prognosis. Advances in the understanding of tumor biology have led to the development of several targeted treatments, which have been evaluated in clinical trials. This article is a comprehensive review of all clinical trials evaluating the effect of targeted treatments in MM. Methods An extensive litera...

2011-01-01

404

Depression Prevention Research: Design, Implementation, and Analysis of Randomized Trials.  

Science.gov (United States)

This document contains three papers concerned with prevention intervention research, a new area of depression research which has shown great promise for contributing new knowledge to the understanding of depression. The first paper, "Clinical Trials vs. Prevention Trials: Methodological Issues in Depression Research" (Ricardo F. Munoz), emphasizes…

Munoz, Ricardo F.; And Others

405

Future vision for the quality assurance of oncology clinical trials  

Directory of Open Access Journals (Sweden)

Full Text Available The National Cancer Institute clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence based process improvements for clinical oncology patient care. The cooperative groups are undergoing a transformation process as we further integrate molecular biology into personalized patient care and move to incorporate international partners in clinical trials. To support this vision, data acquisition and data management informatics tools must become both nimble and robust to support transformational research at an enterprise level. Information, including imaging, pathology, molecular biology, radiation oncology, surgery, systemic therapy and patient outcome data needs to be integrated into the clinical trial charter using adaptive clinical trial mechanisms for design of the trial. This information needs to be made available to investigators using digital processes for real time data analysis. Future clinical trials will need to be designed and completed in a timely manner facilitated by nimble informatics processes for data management. This paper discusses both past experience and future vision for clinical trials as we move to develop data management and quality assurance processes to meet the needs of the modern trial.

ThomasFitzGerald, MD

2013-03-01

406

Book review: writing history in international criminal trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

In this engaging and accessible book, Richard Ashby Wilson addresses key questions related to the legal relevance of history in international criminal trials. Should history play a role in trials, what form should it take, and why does it matter? What can history explain about criminal accountability, crimes under international law, and conflict? Reviewed by Tara O’Leary.

O Leary, Tara

2012-01-01

407

Trial-managed discharge of saline water to Hunter River  

Energy Technology Data Exchange (ETDEWEB)

A trial scheme to manage salinity levels in the Hunter River was undertaken during January and February of 1993. The trial has led to a greater understanding of the relationship between water quality and quantity within the Hunter and engaged a sense of co-operation between the stakeholders.

Harris, E.

1993-01-01

408

Medicare Policy Change Helped Boost Elderly Enrollment in Cancer Trials  

Science.gov (United States)

Since the federal Medicare program revised its policy and began paying for the routine patient care costs of clinical trials, the percentage of patients using Medicare plus supplemental insurance to pay for their care during a clinical trial has increased, according to a study in the Journal of Clinical Oncology (published online Dec. 5, 2005).

409

Adaptive design methods in clinical trials – a review  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract In recent years, the use of adaptive design methods in clinical research and development based on accrued data has become very popular due to its flexibility and efficiency. Based on adaptations applied, adaptive designs can be classified into three categories: prospective, concurrent (ad hoc, and retrospective adaptive designs. An adaptive design allows modifications made to trial and/or statistical procedures of ongoing clinical trials. However, it is a concern that the actual patient population after the adaptations could deviate from the originally target patient population and consequently the overall type I error (to erroneously claim efficacy for an infective drug rate may not be controlled. In addition, major adaptations of trial and/or statistical procedures of on-going trials may result in a totally different trial that is unable to address the scientific/medical questions the trial intends to answer. In this article, several commonly considered adaptive designs in clinical trials are reviewed. Impacts of ad hoc adaptations (protocol amendments, challenges in by design (prospective adaptations, and obstacles of retrospective adaptations are described. Strategies for the use of adaptive design in clinical development of rare diseases are discussed. Some examples concerning the development of Velcade intended for multiple myeloma and non-Hodgkin's lymphoma are given. Practical issues that are commonly encountered when implementing adaptive design methods in clinical trials are also discussed.

Chang Mark

2008-05-01

410

Towards a framework of success factors for clinical trials  

DEFF Research Database (Denmark)

Clinical trials in the pharmaceutical industry are the most critical part of the drug development process with respect to obtaining the market approval from the authorities. Clinical trials are highly expensive, time-consuming and often unsuccessful. While new product development (NPD) literature has extensively investigated success factors in R&D projects, it has not directly addressed success factors in clinical trials, as the late testing stage of a NPD yet. The aim of this paper is to enhance our understanding of the clinical trial management by creating a new conceptual framework of success factors. This paper creates the new framework by combining success factors from NPD literature and from empirical evidence collected through 11 semi-structured interviews with experts in clinical trials. The framework of success factors provides managerial guidelines for practitioners to optimize clinical trials reducing failures and increasing profits. The framework directs managerial focus on the most important factors for success and helps managers in decision-making of operational tasks. The framework can also be applied as a checklist for assessing the status of a clinical trial and later as a benchmarking tool to compare clinical trial processes. Dependencies among the identified factors seem to exist, thus a set of propositions, can be developed from the success factors and be the basis for future empirical testing.

Buonansegna, Erika; Salomo, Søren

2012-01-01

411

Controlled trial of slow-release aminophylline in childhood asthma: are short-term trials valid?  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Slow-release aminophylline, although widely used for the prophylaxis of childhood asthma, has had only limited formal assessment. A four-month double-blind cross-over trial of slow-release aminophylline (14 mg/kg twice daily) was carried out in 24 children with perennial asthma. Satisfactory serum theophylline concentrations were obtained in 17 children, with few side effects. There was a significant improvement in mild daytime and night-time symptoms. The incidence of more severe symptoms wa...

1982-01-01

412

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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 randomi...

2011-01-01

413

Putting Direct Perpetrators on Trial: the Ovcara Massacre Trial in Belgrade  

Digital Repository Infrastructure Vision for European Research (DRIVER)

This paper is based on ethnographical fieldwork conducted in The Hague, Croatia and Serbia. It addresses the distinction between command and individual responsibility on the one hand, and between individual responsibility and collective guilt on the other, by focusing on the two trials related to the Ovcara massacre, the one in the International Criminal Tribunal for the former Yugoslavia (ICTY) and the one in Belgrade, and on non-juridical attempts to deal with the past in Serbia. My main qu...

Mahieu, Stephanie

2007-01-01

414

Total or Partial Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial  

Science.gov (United States)

Background In the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two fundamentally different approaches to knee replacement for patients with unicompartmental disease: some surgeons feel that it is always best to replace both the knee compartments with a total knee replacement (TKR); whereas others feel it is best to replace just the damaged component of the knee using a partial or unicompartment replacement (UKR). Both interventions are established and well-documented procedures. Little evidence exists to prove the clinical and cost-effectiveness of either management option. This provides an explanation for the high variation in treatment of choice by individual surgeons for the same knee pathology. The aim of the TOPKAT study will be to assess the clinical and cost effectiveness of TKRs compared to UKRs in patients with medial compartment osteoarthritis. Methods/Design The design of the study is a single layer multicentre superiority type randomised controlled trial of unilateral knee replacement patients. Blinding will not be possible as the surgical scars for each procedure differ. We aim to recruit 500 patients from approximately 28 secondary care orthopaedic units from across the UK including district general and teaching hospitals. Participants will be randomised to either UKR or TKR. Randomisation will occur using a web-based randomisation system. The study is pragmatic in terms of implant selection for the knee replacement operation. Participants will be followed up for 5 years. The primary outcome is the Oxford Knee Score, which will be collected via questionnaires at 2 months, 1 year and then annually to 5 years. Secondary outcomes will include cost-effectiveness, patient satisfaction and complications data. Trial registration Current Controlled Trials ISRCTN03013488; ClinicalTrials.gov Identifier: NCT01352247

2013-01-01

415

How to Read a Clinical Trial Paper: A Lesson in Basic Trial Statistics  

Digital Repository Infrastructure Vision for European Research (DRIVER)

While the number of clinical trials performed yearly is increasing, the application of these results to individual patients is quite difficult. This article reviews key portions of the process of applying research results to clinical practice. The first step involves defining the study population and determining whether these patients are similar to the patients seen in clinical practice in terms of demographics, disease type, and disease severity. The dropout rate should be compared between ...

Govani, Shail M.; Higgins, Peter D. R.

2012-01-01

416

Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Laparoscopic surgery has become popular during the last decade, mainly because it is associated with fewer postoperative complications than the conventional open approach. It remains unclear, however, if this benefit is observed after laparoscopic correction of perforated peptic ulcer (PPU). The goal of the present study was to evaluate whether laparoscopic closure of a PPU is as safe as conventional open correction. The study was based on a randomized controlled trial in which nine medical c...

Bertleff, M. J. O. E.; Halm, J. A.; Bemelman, W. A.; Ham, A. C.; Harst, E.; Oei, H. I.; Smulders, J. F.; Steyerberg, E. W.; Lange, J. F.

2009-01-01

417

Placebo control and clinical trial of Chinese medicine  

Directory of Open Access Journals (Sweden)

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

Jing Wu

2010-10-01

418

The status of clinical trials: Cause for concern  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Americans see clinical research as important, with over 15 million American residents participating in NIH-sponsored studies in 2008 and growing yearly. Methods Documents reporting NIH supported Clinical Research projects were reviewed. Results When compared with other studies, the number of interventional Phase III and Phase IV trials have decreased from 20% to 4.4% from 1994-2008. Conclusions This finding most likely has occurred for several reasons. One reason is that the physician lacks an infrastructure for designing and carrying out trials. This lack is because of an absence of a coordinated effort to train clinical trialists. It is clear that the Nation needs a more purposeful approach to developing and maintaining the infrastructure for designing and conducting clinical trials. Building it de novo trial by trial is profoundly inefficient, to say nothing about time consuming and error prone.

Meinert Curtis L

2010-07-01

419

Homocysteine-lowering clinical trials in Norway. Cardiovascular and cancer outcomes in the Western Norway B Vitamin Intervention Trial and the Norwegian Vitamin Trial  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Introduction: Observational studies have reported associations between levels of the amino acid homocysteine in the circulation and risk of cardiovascular disease. Oral administration of the synthetic B vitamins folic acid and cyanocobalamin (vitamin B12) can lower plasma total homocysteine levels. In the Western Norway B Vitamin Intervention Trial (WENBIT) and the Norwegian Vitamin Trial (NORVIT), patients with ischemic heart disease were randomized to groups receiving folic acid plus vitami...

Ebbing, Marta

2010-01-01

420

Trial-by-trial fluctuations in CNV amplitude reflect anticipatory adjustment of response caution.  

Science.gov (United States)

The contingent negative variation, a slow cortical potential, occurs when humans are warned by a stimulus about an upcoming task. The cognitive processes that give rise to this EEG potential are not yet well understood. To explain these processes, we adopt a recently developed theoretical framework from the area of perceptual decision-making. This framework assumes that the basal ganglia control the tradeoff between fast and accurate decision-making in the cortex. It suggests that an increase in cortical excitability serves to lower response caution, which results in faster but more error prone responding. We propose that the CNV reflects this increased cortical excitability. To test this hypothesis, we conducted an EEG experiment in which participants performed the random dot motion task either under speed or under accuracy stress. Our results show that trial-by-trial fluctuations in participants' response speed as well as model-based estimates of response caution correlated with single-trial CNV amplitude under conditions of speed but not accuracy stress. We conclude that the CNV might reflect adjustments of response caution, which serves to enhance quick decision-making. PMID:24699015

Boehm, Udo; van Maanen, Leendert; Forstmann, Birte; van Rijn, Hedderik

2014-08-01

 
 
 
 
421

Selection of intervention components in an internet stop smoking participant preference trial: beyond randomized controlled trials.  

Science.gov (United States)

To address health problems that have a major impact on global health requires research designs that go beyond randomized controlled trials. One such design, the participant preference trial, provides additional information in an ecologically valid manner, once intervention efficacy has been demonstrated. The current study presents illustrative data from a participant preference trial of an internet-based smoking cessation intervention. Participants (N=7763) from 124 countries accessed the intervention and were allowed to choose from nine different site components to aid their quit attempt. Of consenting participants, 36.7% completed at least one follow-up assessment. Individuals with depression were more likely to choose a mood management module and participants who smoked a higher number of cigarettes were more likely to choose a cigarette counter and a nicotine replacement therapy guide. Furthermore, depressed participants selecting the mood management component were more likely to report at least one successful 7 day quit (37.2% vs. 22.2%) in the 12 months following the intervention. Thus, participants with depressive symptoms appear to make choices on the basis of their needs and to benefit from these decisions. This suggests that providing the ability to customize previously validated resources may be a successful way to widely disseminate interventions. PMID:22985547

Schueller, Stephen M; Leykin, Yan; Pérez-Stable, Eliseo J; Muñoz, Ricardo F

2013-01-30

422

From HOPE trial to ONTARGET trial: the «hope» to reach the «target» — to improve prognosis in high risk patients  

Directory of Open Access Journals (Sweden)

Full Text Available Results of HOPE trial are analyzed. It is noted, that treatment with angiotensine converting enzyme inhibitor (iACE ramipril improves the prognosis in high risk cardio-vascular patients. The objectives and study design of ONTARGET/TRANSCEND trials are introduced. Perspectives of joint use of ACE inhibitor and antagonist of angiotensin II receptor are discussed.

Yu.M. Lopatin

2006-01-01

423

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

Science.gov (United States)

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

2010-10-14

424

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

Science.gov (United States)

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

2012-02-21

425

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

Science.gov (United States)

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

2011-08-19

426

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

Science.gov (United States)

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

2012-04-16