WorldWideScience
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A proposition well known to geometers  

Science.gov (United States)

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

Erlichson, Herman

2001-03-01

2

Video Streaming Performance Under Well-Known Packet Scheduling Algorithms  

Directory of Open Access Journals (Sweden)

Full Text Available Video streaming is becoming increasingly popular among the wireless users. However, supporting videostreaming over the wireless networks is not an easy task due to the dynamic radio propagationenvironment, limited radio resources as well as Quality of Service (QoS requirements of the videostreaming that need to be satisfied at acceptable levels. Most studies proposed to support video streamingare computationally expensive to be used in Orthogonal Frequency Division Multiple Access (OFDMAbased wireless IP networks. This paper evaluates video streaming performance under three well-knownalgorithms that are more practical to be used in the OFDMA based wireless IP networks due to theirreduced complexity. It is demonstrated via computer simulation that Proportional Fair (PF algorithmoutperforms other well-known algorithms by providing video streaming QoS at acceptable levels whilstmaximizing cell throughput.

Huda Adibah Mohd Ramli

2011-02-01

3

Low, Superlow, and Superduperlow Sets: An Exposition of a Known But Not Well-Known Result  

OpenAIRE

A set is low if A' \\le_T HALT. A set is superlow if A' \\le_tt HALT. A set is superduperlow if A' \\le_btt HALT. While it was known that any superduperlow is decidable it does not seem to be well known. We include two unpublished proofs of this result: One from Carl Jockush and one from Frank Stephan.

Gasarch, William

2015-01-01

4

How to Normalize Co-Occurrence Data? An Analysis of Some Well-Known Similarity Measures  

OpenAIRE

In scientometric research, the use of co-occurrence data is very common. In many cases, a similarity measure is employed to normalize the data. However, there is no consensus among researchers on which similarity measure is most appropriate for normalization purposes. In this paper, we theoretically analyze the properties of similarity measures for co-occurrence data, focusing in particular on four well-known measures: the association strength, the cosine, the inclusion index, and the Jaccard...

Eck, N. J. P.; Waltman, L. R.

2009-01-01

5

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

6

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

OpenAIRE

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

7

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

8

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

Science.gov (United States)

...communications by or on behalf of well-known seasoned issuers. 230.163 Section...communications by or on behalf of well-known seasoned issuers. Preliminary Note to...an offering by or on behalf of a well-known seasoned issuer, as defined in...

2010-04-01

9

The antiretroviral lectin cyanovirin-N targets well-known and novel targets on the surface of Entamoeba histolytica trophozoites.  

Science.gov (United States)

Entamoeba histolytica, the protist that causes amebic dysentery and liver abscess, has a truncated Asn-linked glycan (N-glycan) precursor composed of seven sugars (Man(5)GlcNAc(2)). Here, we show that glycoproteins with unmodified N-glycans are aggregated and capped on the surface of E. histolytica trophozoites by the antiretroviral lectin cyanovirin-N and then replenished from large intracellular pools. Cyanovirin-N cocaps the Gal/GalNAc adherence lectin, as well as glycoproteins containing O-phosphodiester-linked glycans recognized by an anti-proteophosphoglycan monoclonal antibody. Cyanovirin-N inhibits phagocytosis by E. histolytica trophozoites of mucin-coated beads, a surrogate assay for amebic virulence. For technical reasons, we used the plant lectin concanavalin A rather than cyanovirin-N to enrich secreted and membrane proteins for mass spectrometric identification. E. histolytica glycoproteins with occupied N-glycan sites include Gal/GalNAc lectins, proteases, and 17 previously hypothetical proteins. The latter glycoproteins, as well as 50 previously hypothetical proteins enriched by concanavalin A, may be vaccine targets as they are abundant and unique. In summary, the antiretroviral lectin cyanovirin-N binds to well-known and novel targets on the surface of E. histolytica that are rapidly replenished from large intracellular pools. PMID:20852023

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

2010-11-01

10

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

DEFF Research Database (Denmark)

Background. Allergic contact dermatitis is triggered by chemicals in the environment. Primary prevention is aimed at minimizing the risk of induction, whereas secondary and tertiary prevention are aimed at reducing elicitation. Objectives. To identify the elicitation doses that will elicit an allergic reaction in 10% of allergic individuals under patch test conditions (ED10 patch test) for different allergens, and to compare the results with those for different allergens and with animal data indicating sensitizing potency from the literature. Materials and methods. The literature was searched for patch test elicitation studies that fulfilled six selected criteria. The elicitation doses were calculated, and fitted dose–response curves were drawn. Results. Sixteen studies with eight different allergens–methylchloroisothiazolinone/ methylisothiazolinone, formaldehyde, nickel, cobalt, chromium, isoeugenol, hydroxyiso hexyl 3-cyclohexene carboxaldehyde, and methyldibromo glutaronitrile–were selected. The median ED10 value was 0.835 µg/cm2. The ED10 patch test values were all within a factor of 7 from the lowest to the highest value, leaving out three outliers. No obvious patterns between the sensitization and elicitation doses for the allergens were found. Conclusions. We found a rather small variation in the ED10 patch test between the allergens, and no clear relationship between induction potency and elicitation threshold of a range of allergens. This knowledge may stimulate thoughts on introducing a generic approach for limitations in exposure to well-known allergens.

Neergaard, Louise Arup; Menné, Torkil

2011-01-01

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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

12

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

Directory of Open Access Journals (Sweden)

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

Jaime Campos-Castello

2007-01-01

13

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

Scientific Electronic Library Online (English)

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

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

14

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

OpenAIRE

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 ...

Akbulut, Yavuz

2007-01-01

15

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

Scientific Electronic Library Online (English)

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

Shi-Min, Yuan; Hua, Jing.

2011-06-01

16

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.

2008-03-01

17

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

Directory of Open Access Journals (Sweden)

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

Constanza Torres U

2008-03-01

18

Matter Collineations of Some Well Known Spacetimes  

CERN Document Server

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

Sharif, M

2001-01-01

19

Beyond trial types.  

Science.gov (United States)

Conventional wisdom on psychological experiments has held that when one or more independent variables are manipulated it is essential that all other conditions are kept constant such that confounding factors can be assumed negligible (Woodworth, 1938). In practice, the latter assumption is often questionable because it is generally difficult to guarantee that all other conditions are constant between any two trials. Therefore, the most common way to check for confounding violations of this assumption is to split the experimental conditions in terms of "trial types" to simulate a reduction of unintended trial-by-trial variation. Here, we pose a method which is more general than the use of trial types: use of mathematical models treating measures of potentially confounding factors and manipulated variables as equals on the single-trial level. We show how the method can be applied with models that subsume under the generalized linear item response theory (GLIRT), which is the case for most of the well-known psychometric models (Mellenbergh, 1994). As an example, we provide a new analysis of a single-letter recognition experiment using a nested likelihood ratio test that treats manipulated and measured variables equally (i.e., in exactly the same way) on the single-trial level. The test detects a confounding interaction with time-on-task as a single-trial measure and yields a substantially better estimate of the effect size of the main manipulation compared with an analysis made in terms of trial types. PMID:24793447

Dyrholm, Mads; Vangkilde, Signe; Bundesen, Claus

2015-05-01

20

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

Scientific Electronic Library Online (English)

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

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

2014-11-01

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Public, epicureans celebrate well-known dining guide  

Science.gov (United States)

Centuries ago, the experience of â??dining outâ? for most travelers would have been a potentially harrowing one. Faced with few options, most persons on the road would have to settle for the unpredictable fare of a local innkeeper. With the arrival of the automobile and the expansion of dining options, travelers often had more choices, but how to choose? One such traveling salesman by the name of Duncan Hines compiled a list of 167 dining establishments in 1935 that he soon began to pass out to friends and acquaintances. Soon, a deluge of dining guides came on the market over the coming decades, and one of these young upstarts recently celebrated its 25th year in existence. The Zagat Survey was first published in 1979 as a guide to restaurants in New York, and has since grown to cover the entire country, and also branched out into other subjects to rate and pick apart at length, including golf, hotels, and nightlife. The guides are the inventions of Tim and Nina Zagat, who originally started the guidebook as a small hobby. Despite the guidebooksâ?? popularity, they are not without their critics. As anyone can logon to the Zagat website and cast their votes on various aspects of the dining experience at different restaurants, some have claimed that this process results in a widely varying range of opinions, and that some of these opinions undermine the more qualified opining of food critics and professional chefs.The first link leads to a recent piece from Slate.com on the long-running restaurant guidebook series, and includes a brief interview with Tim Zagat. The second link will whisk visitors away to an article from this Wednesdayâ??s San Francisco Chronicle that discusses the online voting process utilized by Zagat that some suggest may be compromising the guidebookâ??s credibility and accuracy. The third link leads to another article from the Chicago Sun-Times that discusses the results of the annual Zagat survey of the nationâ??s top restaurants. Interestingly enough, the survey finds that Philadelphians are the best tippers in the country, and that denizens of the â??Second Cityâ? donâ??t tip so poorly either. The fourth link leads to the Zagat homepage, where visitors can offer their own informed opinions on various restaurants from Ivarâ??s Acres of Clams in Seattle to the legendary Rainbow Room in New York. The fifth link offers some biographical information about that longtime restaurant critic, Mr. Duncan Hines, courtesy of the equally venerable corporate entity that bears his name. The final link leads to a fun story from Forbes.com from several weeks ago that profiles the most expensive restaurants in the United States, including the Ginza Sushiko in Los Angeles, where meals costs over $600 for a mere two persons.

22

Video Streaming Performance Under Well-Known Packet Scheduling Algorithms  

OpenAIRE

Video streaming is becoming increasingly popular among the wireless users. However, supporting videostreaming over the wireless networks is not an easy task due to the dynamic radio propagationenvironment, limited radio resources as well as Quality of Service (QoS) requirements of the videostreaming that need to be satisfied at acceptable levels. Most studies proposed to support video streamingare computationally expensive to be used in Orthogonal Frequency Division Multiple Access (OFDMA)bas...

Huda Adibah Mohd Ramli; Kumbesan Sandrasegaran; Riyaj Basukala; Rachod Patachaianand; Toyoba Sohana Afrin

2011-01-01

23

Clinical Trials  

OpenAIRE

The clinical practice of resuscitation science is dependent on discoveries generated in the basic science and animal laboratory and then translated into clinical trials for application in humans. The successful implementation of prospective, randomized, controlled, clinical trials in the field of cardiac arrest remains challenging and continues to evolve. Funding for clinical trials of cardiac arrest is limited, and there are significant obstacles to performing such studies because of the ina...

Aufderheide, Tom P.

2010-01-01

24

Clinical Trials  

Directory of Open Access Journals (Sweden)

Full Text Available The clinical practice of resuscitation science is dependent on discoveries generated in the basic science and animal laboratory and then translated into clinical trials for application in humans. The successful implementation of prospective, randomized, controlled, clinical trials in the field of cardiac arrest remains challenging and continues to evolve. Funding for clinical trials of cardiac arrest is limited, and there are significant obstacles to performing such studies because of the inability to obtain informed consent under these emergency circumstances. The absence of reliable national statistics on cardiac arrest, evaluation of neurological outcome, and potential confounders such as post-resuscitation hospital-based care and quality of cardiopulmonary resuscitation (CPR continue to challenge cardiac arrest clinical trials. Nonetheless, the immense public health burden of cardiac arrest is being recognized, appropriate public health initiatives to address the problem are being implemented, and the resuscitation research community is meeting this challenge.

TOM P. AUFDERHEIDE

2010-09-01

25

Stroke Trials Registry  

Science.gov (United States)

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

26

Participating in Clinical Trials  

Medline Plus

Full Text Available ... supportive care trials. Treatment Trials In treatment trials, researchers may gather information about experimental treatments, their risks, ... this basic research. Screening Trials In screening trials, researchers study ways of finding a disease before symptoms ...

27

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 ... phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials to be ...

28

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 ... the risk of getting a disease or a specific medical problem. These trials find out if lifestyle ...

29

Participating in Clinical Trials  

Medline Plus

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

30

Participating in Clinical Trials  

Medline Plus

Full Text Available ... is safer or more effective. The five main types of clinical trials are treatment, screening, diagnostic, prevention, ... tests that look for genes linked to some types of disease. Diagnostic Trials In diagnostic trials, researchers ...

31

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 ...

32

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 ... of caregivers, support groups, and various types of social interventions. Supportive care interventions are not intended to ...

33

RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH  

OpenAIRE

This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as “ma...

Reichman, Jerome H.

2009-01-01

34

Preventive Effect of Korean Red Ginseng for Acute Respiratory Illness: A Randomized and Double-Blind Clinical Trial  

OpenAIRE

Korean Red Ginseng (KRG) is a functional food and has been well known for keeping good health due to its anti-fatigue and immunomodulating activities. However, there is no data on Korean red ginseng for its preventive activity against acute respiratory illness (ARI). The study was conducted in a randomized, double-blinded, placebo-controlled trial in healthy volunteers (Clinical Trial Number: NCT01478009). Our primary efficacy end point was the number of ARI reported and secondary efficacy en...

Lee, Chang-seop; Lee, Ju-hyung; Oh, Mira; Choi, Kyung-min; Jeong, Mi Ran; Park, Jong-dae; Kwon, Dae Young; Ha, Ki-chan; Park, Eun-ock; Lee, Nuri; Kim, Sun-young; Choi, Eun-kyung; Kim, Min-gul; Chae, Soo-wan

2012-01-01

35

[Type 3 membranoproliferative glomerulonephritis: an unusual variety of well-known pathology].  

Science.gov (United States)

Light microscopy, immunohistochemistry, and submiscroscopy were used to study a renal biopsy specimen obtained from a 51-year-old old male suffering from type 3 membranoproliferative glomerulonephritis (MPGN-3) concurrent with HCV infection. Along with the signs characteristic of MPGN-3 (glomerulosclerosis; crescents; subendothelial and subepithelial deposits; proliferation of mesangial and endothelial cells), abundant pro- and myelocytes were found in the glomerular capillary lumens with active granular formation in the Golgi apparatus and with granular exocytosis into the glomerular basement membrane. Apoptotic elements were recorded among both glomerular and tubular epithelial cells. PMID:19507577

Khokhlov, S E; Borovo?, S G; Vorob'eva, O A; Borisova, E A; Kardanova, Zh Zh; Nevorotin, A I

2009-01-01

36

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

Czech Academy of Sciences Publication Activity Database

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

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

37

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

38

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

OpenAIRE

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

Mohmood Mohammadian; Hamidreza Asgari Dehabadi

2012-01-01

39

Direct Activation of Human Phospholipase C by Its Well Known Inhibitor U73122*  

OpenAIRE

Phospholipase C (PLC) enzymes are an important family of regulatory proteins involved in numerous cellular functions, primarily through hydrolysis of the polar head group from inositol-containing membrane phospholipids. U73122 (1-(6-((17?-3-methoxyestra-1,3,5(10)-trien-17-yl)amino)hexyl)-1H-pyrrole-2,5-dione), one of only a few small molecules reported to inhibit the activity of these enzymes, has been broadly applied as a pharmacological tool to implicate PLCs in diverse experimental phenot...

Klein, Ryan R.; Bourdon, David M.; Costales, Chester L.; Wagner, Craig D.; White, Wendy L.; Williams, Jon D.; Hicks, Stephanie N.; Sondek, John; Thakker, Dhiren R.

2011-01-01

40

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

41

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

42

Taxonomic validation of a well-known odontoglossum (orchidaceae: oncidiinae) “ghost”  

Scientific Electronic Library Online (English)

Full Text Available The plant that was first called “Odontoglossum wyattianum” by Gurney Wilson was exhibited at a meeting of the Royal Horticultural Society on January 3, 1928. No official description was ever published and no type specimen was ever designated, or has surfaced, hence making this distinct species a tax [...] onomic ‘ghost’. The taxonomic validation of Odontoglossum wyattianum is made here through the designation of a holotype, together with a diagnosis, a brief taxonomic history and comparison with similar and closely related species.

Stig, Dalström.

2014-12-01

43

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

OpenAIRE

We investigate the conditional power under the framework of linear regression models so that it can be applied to most actual clinical trials in which multiple treatment effects and covariate effects are included. It is well known that the standard power of a regular test for a treatment contrast depends on unknown parameters only through the contrast itself. However it is not true in general for conditional power. Conditions for this to happen are established here and some instances are ill...

Hedayat, A. S.; Sinha, Bikas K.; Li Wei

2012-01-01

44

Clinical Trial Results: A Clinical Trial Bazaar!  

OpenAIRE

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

Fojo, Antonio Tito; Bates, Susan E.

2014-01-01

45

Participating in Clinical Trials  

Medline Plus

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

46

Participating in Clinical Trials  

Medline Plus

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 ...

47

Participating in Clinical Trials  

Science.gov (United States)

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

48

Participating in Clinical Trials  

Medline Plus

Full Text Available ... National Institutes of Health funds much of this basic research. Screening Trials In screening trials, researchers study ... nutritious foods, can prevent a problem taking certain medicines, or vitamins, or getting vaccines will prevent a ...

49

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.

50

Diet restriction in migraine, based on IgG against foods: A clinical double-blind, randomised, cross-over trial  

OpenAIRE

Introduction: It is well-known that specific foods trigger migraine attacks in some patients. We aimed to investigate the effect of diet restriction, based on IgG antibodies against food antigens on the course of migraine attacks in this randomised, double blind, cross-over, headache-diary based trial on 30 patients diagnosed with migraine without aura.

Alpay, Kadriye; Ertas?, Mustafa; Orhan, Elif Kocasoy; U?stay, Didem Kanca; Lieners, Camille; Baykan, Betu?l

2010-01-01

51

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

52

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

53

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 ...

54

Participating in Clinical Trials  

Medline Plus

Full Text Available ... The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials to be conducted to determine if the drug can be approved for use. A Phase I trial tests an experimental treatment on a ...

55

Participating in Clinical Trials  

Medline Plus

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

56

Clinical trials in children.  

Science.gov (United States)

Safety and efficacy data on many medicines used in children are surprisingly scarce. As a result children are sometimes given ineffective medicines or medicines with unknown harmful side effects. Better and more relevant clinical trials in children are needed to increase our knowledge of the effects of medicines and to prevent the delayed or non-use of beneficial therapies. Clinical trials provide reliable evidence of treatment effects by rigorous controlled testing of interventions on human subjects. Paediatric trials are more challenging to conduct than trials in adults because of the paucity of funding, uniqueness of children and particular ethical concerns. Although current regulations and initiatives are improving the scope, quantity and quality of trials in children, there are still deficiencies that need to be addressed to accelerate radically equitable access to evidence-based therapies in children. PMID:24325152

Joseph, Pathma D; Craig, Jonathan C; Caldwell, Patrina H Y

2015-03-01

57

HIV/AIDS Clinical Trials  

Science.gov (United States)

... safe and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help ... related to HIV Can anyone participate in an HIV/AIDS clinical trial? It depends on the study. ...

58

Randomized Controlled Trial on the Effects of Tualang Honey and Hormonal Replacement Therapy (HRT) on Cardiovascular Risk Factors, Hormonal Profiles and Bone Density Among Postmenopausal Women: A Pilot Study  

OpenAIRE

Results of recent trial have shown some negative effects of HRT on postmenopausal women. Therefore, there has been a need to search for an alternative treatment and honey is one of the well known traditional remedies used in minimizing postmenopausal problems. The objectives of the study were to investigate the effects of Tualang honey on the cardiovascular risk factors, changes in hormonal profiles and also effect on the bone. A randomized controlled trial comparing the effects of Tualang ho...

Nik Hazlina Nik Hussain; Siti Amrah Sulaiman; Intan Idiana Hassan; Azidah Abdul Kadir; Norhayati Mohd Nor; Shaiful Bahari Ismail; Lili Husniati Yaacob; Rahimah Zakaria; Nazlah Shaniza Shafie; Juhara Haron; Kamarul Imran Musa

2012-01-01

59

[Globalization of clinical trials].  

Science.gov (United States)

Based on reviews of the Japanese clinical trial situation in lung cancer, gastric cancer, prostate cancer and breast cancer, it was clear that much progress has been made in short time. There are considerable differences between Japan and the West and also differences between clinical areas in Japan. For regulatory purposes bridging studies have become increasingly important. Use of identical protocols are required for effective bridging. Participations in global phase III trials is the best way of achieving registration in Japan. For successful global trials in Japan it is important to include Japanese investigators in the preparation of the protocol and to recognise the challenges facing such a project. Clinical practice in diagnosis and treatment have many differences, thus it is recommended to have clear and detailed information in the protocol. Hard end points like survival are important since they are not biased by cultural differences. There are clear difficulties with HE or QOL outcomes. The emergence of focus on evidence based medicine is also happening in Japan and will help to harmonize documentation across the world. For large adjuvant or prevention cancer global trials are essential. To facilitate global studies further development of infrastructure is necessary in Japan. Use of electronic data capture web based communication etc. will help overcome communication difficulties. Other improvements that will make Japanese participation in global trials easier and better include establishment of clinical trial centre at each hospital, introduction of trial coordinators or study nurses and an improved collaboration with company staff. A critical issue that also need addressing is agreement of centre target recruitment. We need to introduce a new flexible system in Japan if participation in global trial is to be optimised. If we can address these issues Japanese investigators and collaborative groups should be able to initiate and lead global trials in the future. PMID:12722692

Akaza, Hideyuki; Fukuoka, Masahiro; Ohtsu, Atsushi; Usami, Michiyuki; Ikeda, Tadashi; Aiba, Keisuke; Isonishi, Seiji; Ohashi, Yasuo; Saijo, Nagahiro; Sone, Saburo; Tsukagoshi, Shigeru; Tsuruo, Takashi; Kato, Masuhiro; Mikami, Osamu; Dong, Rui-Ping; von Euler, Mikael; Blackledge, George; Stribling, Don

2003-04-01

60

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

61

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 ...

62

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 ... nutritious foods, can prevent a problem taking certain medicines, or vitamins, or getting vaccines will prevent a ...

63

Participating in Clinical Trials  

Medline Plus

Full Text Available ... find out if an experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, ... positive, they will approve the experimental drug or device. A Phase IV trial for drugs or devices ...

64

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.

65

Advancing Precision Medicine Trials  

Science.gov (United States)

Advances in cancer genomics are leading to new clinical trials for patients whose tumors will be extensively analyzed genomically and whose treatment will be based on the identified molecular abnormalities.

66

National Lung Screening Trial  

Science.gov (United States)

Information 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.

67

Clinical Trial Phases  

Directory of Open Access Journals (Sweden)

Full Text Available Developers of drugs, biologicals, and medical devices must ensure product safety, demonstrate medical benefit in people, and mass produce the product. Preclinical development starts before clinical trials and the main goals are to determine safety and effectiveness of the intervention. If preclinical studies show that the therapy is safe and effective, clinical trials are started. Clinical trial phases are steps in the research to determine if an intervention would be beneficial or detrimental to humans and include Phases 0, I, II, III, IV, and V clinical studies. Understanding the basis of clinical trial phases will help researchers plan and implement clinical study protocols and, by doing so, improve the number of therapies coming to market for patients.

Vicki L. Mahan

2014-12-01

68

Participating in Clinical Trials  

Medline Plus

Full Text Available ... lifestyle changes, such as exercising more, getting more sleep, keeping mentally active, or eating nutritious foods, can ... positive, they will approve the experimental drug or device. A Phase IV trial for drugs or devices ...

69

Veterinary Clinical Trials  

Science.gov (United States)

... feline Complete heart block—canine Fragmented coronoid processes Spinal cord injuries Acute disc herniations Testing pancreatic function Searchable Clinical Trials Database For Cancer In Pet Animals sponsored by ...

70

Participating in Clinical Trials  

Medline Plus

Full Text Available ... experimental treatment in people. Most of this early research occurs at universities and medical centers across the country. The National Institutes of Health funds much of this basic research. Screening Trials ...

71

Clinical Trial Basics  

Science.gov (United States)

... 000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect ... use. Some concepts to understand Typically, clinical trials compare a new product or therapy with another that ...

72

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

73

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 ... the effects of research treatmenton various types of cancer. Once researchers are satisfied that the treatment has ...

74

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

75

What Is a Clinical Trial?  

Medline Plus

Full Text Available ... in clinical trials is given in a very specific manner, according to written instructions and guidelines called ... clear explanation, patients have many questions about their specific clinical trial. Potential side effects often tops the ...

76

Participating in a Clinical Trial  

Science.gov (United States)

... 28, 2014 Select a Language: Fact Sheet 205 Participating in a Clinical Trial WHAT IS A CLINICAL ... A CLINICAL TRIAL? WHAT ARE THE BENEFITS OF PARTICIPATING? WHAT ARE THE RISKS? HOW ARE PARTICIPANTS PROTECTED? ...

77

Ovarian Cancer Prevention Clinical Trials  

Science.gov (United States)

Programs and Projects Ovarian Cancer Prevention 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

78

What Is a Clinical Trial?  

Medline Plus

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 ...

79

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

International Nuclear Information System (INIS)

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

80

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

Science.gov (United States)

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

Furnham, Adrian; Crump, John

2014-08-01

81

University of Pennsylvania Study finds new combo of chemo and well-known malaria drug delivers double punch to tumors  

Science.gov (United States)

Blocking autophagy -- the process of "self-eating" within cells -- is turning out to be a viable way to enhance the effectiveness of a wide variety of cancer treatments, report researchers from the Abramson Cancer Center at the University of Pennsylvania. Specifically, blocking the action of an acidic inner cell part, which acts like a stomach and chews up proteins for recycling, is the main attack strategy.

82

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.t of emergy accounting.

83

Evolutionarily repurposed networks reveal the well-known antifungal drug thiabendazole to be a novel vascular disrupting agent.  

Science.gov (United States)

Studies in diverse organisms have revealed a surprising depth to the evolutionary conservation of genetic modules. For example, a systematic analysis of such conserved modules has recently shown that genes in yeast that maintain cell walls have been repurposed in vertebrates to regulate vein and artery growth. We reasoned that by analyzing this particular module, we might identify small molecules targeting the yeast pathway that also act as angiogenesis inhibitors suitable for chemotherapy. This insight led to the finding that thiabendazole, an orally available antifungal drug in clinical use for 40 years, also potently inhibits angiogenesis in animal models and in human cells. Moreover, in vivo time-lapse imaging revealed that thiabendazole reversibly disassembles newly established blood vessels, marking it as vascular disrupting agent (VDA) and thus as a potential complementary therapeutic for use in combination with current anti-angiogenic therapies. Importantly, we also show that thiabendazole slows tumor growth and decreases vascular density in preclinical fibrosarcoma xenografts. Thus, an exploration of the evolutionary repurposing of gene networks has led directly to the identification of a potential new therapeutic application for an inexpensive drug that is already approved for clinical use in humans. PMID:22927795

Cha, Hye Ji; Byrom, Michelle; Mead, Paul E; Ellington, Andrew D; Wallingford, John B; Marcotte, Edward M

2012-01-01

84

Antimicrobial activity of high-mobility-group box 2: a new function to a well-known protein.  

Science.gov (United States)

The human intestinal tract is highly colonized by a vast number of microorganisms. Despite this permanent challenge, infections remain rare, due to a very effective barrier defense system. Essential effectors of this system are antimicrobial peptides and proteins (AMPs), which are secreted by intestinal epithelial and lymphoid cells, balance the gut microbial community, and prevent the translocation of microorganisms. Several antimicrobial proteins have already been identified in the gut. Nonetheless, we hypothesized that additional AMPs are yet to be discovered in this setting. Using biological screening based on antimicrobial function, here we identified competent antibacterial activity of high-mobility-group box 2 (HMGB2) against Escherichia coli. By recombinant expression, we confirmed this biologically new antimicrobial activity against different commensal and pathogenic bacteria. In addition, we demonstrated that the two DNA-binding domains (HMG boxes A and B) are crucial for the antibiotic function. We detected HMGB2 in several gastrointestinal tissues by mRNA analysis and immunohistochemical staining. In addition to the nuclei, we also observed HMGB2 in the cytoplasm of intestinal epithelial cells. Furthermore, HMGB2 was detectable in vitro in the supernatants of two different cell types, supporting an extracellular function. HMGB2 expression was not changed in inflammatory bowel disease but was detected in certain stool samples of patients, whereas it was absent from control individuals. Taken together, we characterized HMGB2 as an antimicrobial protein in intestinal tissue, complementing the diverse repertoire of gut mucosal defense molecules. PMID:23877675

Küchler, Robert; Schroeder, Bjoern O; Jaeger, Simon U; Stange, Eduard F; Wehkamp, Jan

2013-10-01

85

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

OpenAIRE

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...

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

2003-01-01

86

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. PMID:25182951

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

2014-01-01

87

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

OpenAIRE

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

Wei, Ming Q.; Crespo-ortiz, Maria P.

2012-01-01

88

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

Science.gov (United States)

Background: We are reporting a series of interesting cases, which presented to us with psoriasiform lesions distributed over the acral regions of the body. The cases are unusual because they were resistant to conventional treatment modalities like topical corticosteroids, tacrolimus and oral methotrexate but showed significant improvement on oral zinc therapy. Materials and Methods: Ten patients with characteristic clinical features of distinctive hyperkeratotic plaque in the acral areas, who were resistant to treatment by different modalities including potent topical steroids and oral methotrexate, were included for detailed investigations. A proper history was taken and relevant laboratory investigations were done which included blood count, urine, liver function, renal function, hepatitis-C virus serology and serum zinc levels. Patients were followed up every 2 weeks. Histopathological examinations of the lesional tissue were done at baseline and after 6 weeks of therapy. Patients were given oral zinc daily and no other treatment during the 6 weeks course. Results: All our patients were non-reactive to hepatitis-C. Of the ten patients only one patient (10%) showed low titer of serum zinc, another (10%) showed higher zinc level, while the rest of the patients had normal zinc level. Five of our patients had chronic renal failure, one had Grave's disease and the remaining had no associated systemic illness. Histopathology mostly showed hyperkeratosis, acanthosis, prominent granular layer, spongiosis and dermal infiltrate. After 6 weeks of follow up, all patients showed rapid and remarkable therapeutic response with zinc. Conclusions: We here report a series of patients, discernible because of their uniform clinical presentation of acral hypekeratotic plaques and in showing a noticeable response to zinc. Clinical, histopathological and laboratory investigations were done to rule out diseases of similar morphology including psoriasis, acral necrolytic erythema and lichen simplex chronicus. Authors understand that further studies with greater number cases and more detailed investigations are required to establish exact etio-pathogenesis and nomenclature of this distinct subset of patients. PMID:25814700

Ghosh, Arghyaprasun; Aggarwal, Ishad; De, Abhishek; Samanta, Ayan; Chatterjee, Gobinda; Bala, Sanchaita; Biswas, Projna; Chowdhary, Nidhi

2015-01-01

89

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

Energy Technology Data Exchange (ETDEWEB)

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

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

2012-07-01

90

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

Directory of Open Access Journals (Sweden)

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

Suh Sang-Yeon

2012-01-01

91

Evidence and Clinical Trials.  

Science.gov (United States)

This dissertation explores the use of a mathematical measure of statistical evidence, the log likelihood ratio, in clinical trials. The methods and thinking behind the use of an evidential measure are contrasted with traditional methods of analyzing data, which depend primarily on a p-value as an estimate of the statistical strength of an observed data pattern. It is contended that neither the behavioral dictates of Neyman-Pearson hypothesis testing methods, nor the coherency dictates of Bayesian methods are realistic models on which to base inference. The use of the likelihood alone is applied to four aspects of trial design or conduct: the calculation of sample size, the monitoring of data, testing for the equivalence of two treatments, and meta-analysis--the combining of results from different trials. Finally, a more general model of statistical inference, using belief functions, is used to see if it is possible to separate the assessment of evidence from our background knowledge. It is shown that traditional and Bayesian methods can be modeled as two ends of a continuum of structured background knowledge, methods which summarize evidence at the point of maximum likelihood assuming no structure, and Bayesian methods assuming complete knowledge. Both schools are seen to be missing a concept of ignorance- -uncommitted belief. This concept provides the key to understanding the problem of sampling to a foregone conclusion and the role of frequency properties in statistical inference. The conclusion is that statistical evidence cannot be defined independently of background knowledge, and that frequency properties of an estimator are an indirect measure of uncommitted belief. Several likelihood summaries need to be used in clinical trials, with the quantitative disparity between summaries being an indirect measure of our ignorance. This conclusion is linked with parallel ideas in the philosophy of science and cognitive psychology.

Goodman, Steven N.

1989-11-01

92

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 the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issues focuses on the following selection of drugs: 4'-Thio-ara-C, 5-methyltetrahydrofolate; ABT-089, AD-237, AF-37702, alvocidib hydrochloride, apricitabine, armodafinil, atrasentan, AVE-5883, avian influenza vaccine, azimilide hydrochloride; Banoxantrone, BIBF-1120; CD34+ cells, certolizumab pegol, CHIR-258, cilansetron, CoFactor, CX-3543, cystemustine; D-003, dexloxiglumide, DMXB-anabaseine; Ecogramostim, elcometrine, elcometrine/ethinylestradiol, etravirine; Fenretinide, fingolimod hydrochloride, fospropofol disodium; Gaboxadol, gestodene, glutamine; Human insulin, hyaluronic acid; Incyclinide, indacaterol, ispronicline, istradefylline; Labradimil, lamifiban, lapatinib, L-arginine hydrochloride, liposomal cisplatin, liposome encapsulated paclitaxel, LY-517717; Manidipine hydrochloride/delapril hydrochloride, maraviroc, MBP(82-98), MD-0727, MDX-214, melanotan I, MMR vaccine; Nacystelyn, nalfurafine hydrochloride, nibentan, nilotinib, NK-105; OBI-1, oblimersen sodium, olmesartan medoxomil, olmesartan medoxomil/hydrochlorothiazide, oregovomab; Pexelizumab, PG-116800, PG-CPT, PHA-794428, prasugrel; RC-3095, rDNA insulin, RFB4(dsFv)-PE38, rhEndostatin, rhenium Re-186 etidronate, rhGM-CSF, roflumilast, romidepsin; Sarcosine, SGLU1, SGN-40, succinobucol; TAU, teduglutide, telatinib, tesofensine, tipifarnib, tirapazamine, TKA-731, tolvaptan, trabectedin; Vaccimel, vatalanib succinate, velafermin, vildagliptin, vinflunine; XP-19986; YM-155. PMID:17344945

Bayés, M; Rabasseda, X; Prous, J R

2007-01-01

93

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

Science.gov (United States)

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

Netser, Shai; Dutta, Arkadeb; Gutfreund, Yoram

2014-03-01

94

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

Tomillero, A; Moral, M A

2010-11-01

95

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

Tomillero, A; Moral, M A

2010-12-01

96

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

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

2006-09-01

97

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: 5-Methyltetrahydrofolate, 9-aminocamptothecin; AdPEDF.11, AE-37, albumin interferon alfa, alicaforsen sodium, alvocidib hydrochloride, AMG-706, arginine butyrate, avanafil, axitinib, azimilide hydrochloride; BAY-579352, belagenpumatucel-L, beta-lapachone, BHT-3009, BIBW-2992, bremelanotide, BX-471; Casopitant mesylate, cediranib, certolizumab pegol, CH-1504, ChimeriVax-West Nile, clofazimine, CpG-7909, curcumin, Cypher; Dapoxetine hydrochloride, darusentan, diflomotecan, D-methionine, dnaJP1, D-serine, DTPw-HB Hib-MenAC, DTPw-HepB-Hib; E-7010, ecogramostim, edodekin alfa, EGFRvlll peptide vaccine, elcometrine, elcometrine/ethinylestradiol, elsilimomab, enrasentan, ertumaxomab, etalocib sodium, exisulind; Fenretinide, fesoterodine, fingolimod hydrochloride, fontolizumab; Gefitinib, gemtuzumab ozogamicin, ghrelin (human), GV-1001; HTU-PA, human papillomavirus vaccine; Indacaterol, indiplon, interleukin-21, intranasal insulin, irinotecan hydrochloride/floxuridine, ISIS-301012, ispinesib mesylate, ixabepilone; K562/GM-CSF; Lapatinib, L-BLP-25, linezolid, liposome encapsulated paclitaxel, LY-2124275; MC-1, MC-1/lisinopril, MDX-066, melanoma vaccine, MMR-V, multivalent (ACYW) meningitis vaccine; Nilotinib, nobori, nociceptin; Oblimersen sodium, orbofiban acetate, ospemifene; Paliperidone, panitumumab, PEG-filgrastim, PEGylated interferon alfacon-1, perflubutane, pertuzumab, phenserine tartrate, phVEGF-A165, pleconaril, prasugrel, prednisolone sodium metasulfobenzoate; R-411, recombinant malaria vaccine, rhGM-CSF, roflumilast, romidepsin, ruboxistaurin mesilate hydrate; Sirolimus-eluting stent, SR-4554, St. John's Wort extract; Talabostat, Taxus, TGN-255, tifacogin, tiotropium bromide, tolevamer sodium, trabectedin, tretinoin LF; Vatalanib succinate; Yellow fever vaccine, YM-155. PMID:17235418

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

2006-12-01

98

Gateways to clinical trials.  

Science.gov (United States)

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

Tomillero, A; Moral, M A

2008-10-01

99

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

100

The International Stroke Trial database  

OpenAIRE

Abstract Background We aimed to make individual patient data from the International Stroke Trial (IST), one of the largest randomised trials ever conducted in acute stroke, available for public use, to facilitate the planning of future trials and to permit additional secondary analyses. Methods For each randomised patient, we have extracted data on the variables assessed at randomisation, at the early outcome point (14-days after randomisation or prior discharge) and at 6-months and provide t...

Ag, Sandercock Peter; Niewada Maciej; Cz?onkowska Anna

2012-01-01

101

Radiobiological modeling and clinical trials  

International Nuclear Information System (INIS)

Purpose: Standard clinical trial designs can lead to restrictive conclusions: the 'best recommended treatments' based on trial results, although generally applicable to patient populations, do not necessarily apply to individual patients. In theory, radiobiological modeling, coupled with reliable predictive assays, can be used to rationalize the selection of patients for particular schedules in trials. Materials and Methods: Linear-quadratic modeling of radiotherapy can be used to simulate a clinical trial. This is achieved by random sampling techniques where the key radiobiological parameters (?, ?, Tpot and clonogen number) are selected from known or expected ranges. Clinical trial design in radiotherapy may be improved by formal radiobiological assessment designed to estimate the likely changes in tumor cure probability (TCP) and the likely normal tissue biologically effective dose (BED). Modeling may also be used to rationalize the allocation of patients to a test or standard schedule or for individual optimization of a treatment schedule. Such approaches depend on there being reliable predictive assays of the radiobiological parameters in individual patients. The influence of variations in predictive assay accuracy on the improved outcomes are assessed. Results: Clinical trials, which have been preceded by modeling simulation, offer potentially substantial improvements in the results of cancer treatment by radiotherapy. These exceed the usual gains fotherapy. These exceed the usual gains found in standard clinical trials. Conclusion: Future preclinical trial design should include modeling assessments that indicate how best to structure the trial

102

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)

103

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: Adalimumab, aeroDose insulin inhaler, agomelatine, alendronic acid sodium salt, aliskiren fumarate, alteplase, amlodipine, aspirin, atazanavir; Bacillus Calmette-Guérin, basiliximab, BQ-788, bupropion hydrochloride; Cabergoline, caffeine citrate, carbamazepine, carvedilol, celecoxib, cyclosporine, clopidogrel hydrogensulfate, colestyramine; Dexamethasone, diclofenac sodium, digoxin, dipyridamole, docetaxel, dutasteride; Eletriptan, enfuvirtidie, eplerenone, ergotamine tartrate, esomeprazole magnesium, estramustine phosphate sodium; Finasteride, fluticasone propionate, fosinopril sodium; Ganciclovir, GBE-761-ONC, glatiramer acetate, gliclazide, granulocyte-CSF; Heparin sodium, human isophane insulin (pyr), Hydrochlorothiazide; Ibuprofen, inhaled insulin, interferon alfa, interferon beta-1a; Laminvudine, lansoprazole, lisinopril, lonafarnib, losartan potassium, lumiracoxib; MAb G250, meloxicam methotrexate, methylprednisolone aceponate, mitomycin, mycophenolate mofetil; Naproxen sodium, natalizumab, nelfinavir mesilate, nemifitide ditriflutate, nimesulide; Omalizumab, omapatrilat, omeprazole, oxybutynin chloride; Pantoprazole sodium, paracetamol, paroxetine, pentoxifylline, pergolide mesylate, permixon, phVEGF-A165, pramipexole hydrochloride, prasterone, prednisone, probucol, propiverine hydrochloride; Rabeprazole sodium, resiniferatoxin, risedronate sodium, risperidone, rofecoxib rosiglitazone maleate, ruboxistaurin mesilate hydrate; Selegiline transdermal system, sertraline, sildenafil citrate, streptokinase; Tadalafil, tamsulosin hydrochloride, technosphere/Insulin, tegaserod maleate, tenofovir disoproxil fumarate, testosterone heptanoate, testosterone undecanoate, tipifarnib, tolterodine tartrate, topiramate, troglitazone; Ursodeoxycholic acid; Valdecoxib, valsartan, vardenafil, venlafaxine hydrochloride, VX-745. PMID:12428432

Bayés, M; Rabasseda, X; Prous, J R

2002-09-01

104

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

105

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 can be 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, acarbose, alefacept, alteplase, amisulpride, amoxicillin trihydrate, apomorphine hydrochloride, aprepitant, argatroban monohydrate, aspirin, atenolol; Betamethasone dipropionate, betamethasone valerate, bicalutamide, bleomycin sulfate; Calcium carbonate, candesartan cilexetil, celecoxib, cetirizine hydrochloride, cisplatin, clarithromycin, clavulanate potassium, clomethiazole edisilate, clopidogrel hydrogensulfate, cyclophosphamide, chorionic gonadotropin (human); Dalteparin sodium, desloratadine, dexamethasone, doxorubicin, DPC-083; Efalizumab, efavirenz, enoxaparin sodium, eprosartan mesilate, etanercept, etoposide, ezetimibe; Faropenem daloxate, fenofibrate, fluocinolone acetonide, flutamide, fluvastatin sodium, follitropin beta, fondaparinux sodium; Gabapentin, glibenclamide, goserelin, granisetron hydrochloride; Haloperidol, hydrochlorothiazide; Imiquimod, interferon beta-1a, irbesartan, iseganan hydrochloride; L-758298, lamivudine, lanoteplase, leflunomide, leuprorelin acetate, loratadine, losartan potassium; Melagatran, metformin hydrochloride, methotrexate, metronidazole, micafungin sodium, mitoxantrone hydrochloride; Nelfinavir mesilate, neutral insulin injection, nizatidine; Olopatadine hydrochloride, omeprazole, ondansetron hydrochloride; Pamidronate sodium, paracetamol, paroxetine hydrochloride, perindopril, pimecrolimus, pioglitazone hydrochloride, piroxicam, pleconaril, pralmorelin, pravastatin sodium, prednisolone, prednisone, propofol; Raloxifene hydrochloride, ranpirnase, remifentanil hydrochloride, risedronate sodium, risperidone, rofecoxib, ropinirole hydrochloride, rosuvastatin calcium; Sevoflurane, sildenafil citrate, simvastatin, somatropin; Tacrolimus, tamoxifen citrate, telmisartan, temozolomide, thiopental sodium, tinzaparin sodium, tirofiban hydrochloride, treosulfan, triamcinolone acetonide; Urokinase; Valsartan, vardenafil, vincristine; Warfarin sodium; Ximelagatran; Zidovudine. PMID:12092009

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

2002-05-01

106

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

107

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 the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issues focuses on the following selection of drugs: (-)-Epigallocatechin gallate, (-)-gossypol, 2-deoxyglucose, 3,4-DAP, 7-monohydroxyethylrutoside; Ad5CMV-p53, adalimumab, adefovir dipivoxil, ADH-1, alemtuzumab, aliskiren fumarate, alvocidib hydrochloride, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, amrubicin hydrochloride, AN-152, anakinra, anecortave acetate, antiasthma herbal medicine intervention, AP-12009, AP-23573, apaziquone, aprinocarsen sodium, AR-C126532, AR-H065522, aripiprazole, armodafinil, arzoxifene hydrochloride, atazanavir sulfate, atilmotin, atomoxetine hydrochloride, atorvastatin, avanafil, azimilide hydrochloride; Bevacizumab, biphasic insulin aspart, BMS-214662, BN-83495, bortezomib, bosentan, botulinum toxin type B; Caspofungin acetate, cetuximab, chrysin, ciclesonide, clevudine, clofarabine, clopidogrel, CNF-1010, CNTO-328, CP-751871, CX-717, Cypher; Dapoxetine hydrochloride, darifenacin hydrobromide, dasatinib, deferasirox, dextofisopam, dextromethorphan/quinidine sulfate, diclofenac, dronedarone hydrochloride, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Edaravone, efaproxiral sodium, emtricitabine, entecavir, eplerenone, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, etoricoxib, ezetimibe, ezetimibe/simvastatin; Finrozole, fipamezole hydrochloride, fondaparinux sodium, fulvestrant; Gabapentin enacarbil, gaboxadol, gefitinib, gestodene, ghrelin (human); Human insulin, human papillomavirus vaccine; Imatinib mesylate, immunoglobulin intravenous (human), indiplon, insulin detemir, insulin glargine, insulin glulisine, intranasal insulin, istradefylline, i.v. gamma-globulin, ivabradine hydrochloride, ixabepilone; LA-419, lacosamide, landiolol, lanthanum carbonate, lidocaine/prilocaine, liposomal cisplatin, lutropin alfa; Matuzumab, MBP(82-98), mecasermin, MGCD-0103, MMR-V, morphine hydrochloride, mycophenolic acid sodium salt; Natalizumab, NCX-4016, neridronic acid, nesiritide, nilotinib, NSC-330507; O6-benzylguanine, olanzapine/fluoxetine hydrochloride, omalizumab; Panitumumab, parathyroid hormone (human recombinant), parecoxib sodium, PEG-filgrastim, peginterferon alfa-2a, peginterferon alfa-2b, pegvisomant, pemetrexed disodium, perospirone hydrochloride, pexelizumab, phorbol 12-myristate 13-acetate, pneumococcal 7-valent conjugate vaccine, posaconazole, pramiconazole, prasugrel, pregabalin, prilocaine; rAAV-GAD65, raclopride, rasagiline mesilate, retapamulin, rosuvastatin calcium, rotigotine, rufinamide; SarCNU, SB-743921, SHL-749, sirolimus-eluting stent, sitaxsentan sodium, sorafenib; TachoSil, tadalafil, talampanel, Taxus, tegaserod maleate, telithromycin, telmisartan/hydrochlorothiazide, temsirolimus, tenatoprazole, teriflunomide, tetrathiomolybdate, ticilimumab, timcodar dimesilate, tipifarnib, tirapazamine, TPI, tramiprosate, trifluridine/TPI, trimethoprim; Ularitide, Urocortin 2; Valdecoxib, valganciclovir hydrochloride, valproate magnesium, valspodar, vardenafil hydrochloride hydrate, vitespen, vofopitant hydrochloride, volociximab, vorinostat; Yttrium 90 (90Y) ibritumomab tiuxetan; Ziprasidone hydrochloride, zotarolimus, zotarolimus-eluting stent. PMID:17136234

Bayés, M; Rabasseda, X; Prous, J R

2006-10-01

108

Clinical Trials for Dry AMD  

Science.gov (United States)

... more information, visit ClinicalTrials.gov . February 2015 MacuCLEAR Eyedrops – Recruiting This is a Phase II/III, double ... information, visit Clinical Trials.gov . February 2015 Othera Eye Drops – Not Recruiting This is a Phase II clinical ...

109

Industrial demonstration trials  

International Nuclear Information System (INIS)

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

110

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

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

2002-04-01

111

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

112

Behavioral Therapies Trials  

Science.gov (United States)

Background: Behavior change is integral to the prevention and treatment of many disorders associated with deleterious lifestyles. Rigorous scientific testing of behavior change interventions is an important goal for nursing research. Approach: The stage model for behavioral therapy development is recommended as a useful framework for evaluating behavior change strategies. The NIH model specifies three stages from initial testing of novel behavioral therapies to their dissemination in community settings. Definitions of each step in a Stage I trial and a case example of Mindfulness-Based Stress Reduction (MBSR) in therapeutic community treatment are provided. Results: It is feasible to adapt a behavioral therapy such as MBSR using the stage model framework. Steps in the process include: (a) determining pilot study design and describing the population; (b) modifying the intervention and developing the manual; (c) training the teachers; (d) implementing a pilot study; and (e) monitoring treatment integrity. Discussion: The development of behavior therapies requires the same scientific rigor used in pharmacotherapy research. Stage I of the model enables consideration of the “dose” of a behavioral intervention necessary to achieve behavior change in a defined population. The stage model offers an excellent approach to achieving rigor in a variety of potentially useful therapies of interest to nurse researchers. PMID:17495577

Marcus, Marianne T.; Liehr, Patricia R.; Schmitz, Joy; Moeller, F. Gerald; Swank, Paul; Fine, Micki; Cron, Stanley; Granmayeh, L. Kian; Carroll, Deidra D.

2008-01-01

113

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

114

What Is a Clinical Trial?  

Medline Plus

Full Text Available ... randomization," ensures different therapies are evaluated fairly. The outcome of a clinical trial cannot be guaranteed, and ... receive, possible side effects, your responsibility and possible outcomes. So before signing this statement, be sure to ...

115

What Is a Clinical Trial?  

Medline Plus

Full Text Available ... Once researchers are satisfied that the treatment has potential benefit and acceptable risk, they open clinical trials ... are new, there's always some risk. When discussing potential benefits, ask your doctor about potential risks of ...

116

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 ...

117

What Is a Clinical Trial?  

Medline Plus

Full Text Available ... together through the use of clinical trials. Announcer: Doctors carefully screen patients to find out if the ... York. But since the protocol is written for physicians, your doctor will need to explain the treatment ...

118

What Is a Clinical Trial?  

Medline Plus

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 ...

119

AIDS Clinical Trials Group Network  

Science.gov (United States)

... Matrix State of the ACTG ACTG Operational Manual Templates and Forms Annual Progress Reports Performance Evaluation Program ... Clinical Trials Resources Committees Executive Executive Committee Leadership Steering Committee Scientific Agenda Steering Committee Data Management Committee ...

120

Bayesian Clinical Trials in Action  

OpenAIRE

Although the frequentist paradigm has been the predominant approach to clinical trial design since the 1940s, it has several notable limitations. The alternative Bayesian paradigm has been greatly enhanced by advancements in computational algorithms and computer hardware. Compared to its frequentist counterpart, the Bayesian framework has several unique advantages, and its incorporation into clinical trial design is occurring more frequently. Using an extensive literature review to assess how...

Lee, J. Jack; Chu, Caleb T.

2012-01-01

121

Common statistical concerns in clinical trials  

OpenAIRE

Statistics are an integral part of clinical trials. Elements of statistics span clinical trial design, data monitoring, analyses, and reporting. A solid understanding of statistical concepts by clinicians improves the comprehension and the resulting quality of clinical trials. This manuscript outlines common statistical concerns in clinical trials that are important for clinicians to understand.

Evans, Scott R.

2010-01-01

122

The Styx Field Trial  

Science.gov (United States)

A 13-year assessment has been made of the effectiveness of a monthly drug treatment programme for the control of tapeworms in dogs in order to prevent hydatidosis (Echinococcus granulosus) and cysticercosis (Taenia hydatigena and T. ovis) in sheep. The age-specific prevalence of T. hydatigena in lambs was used as the principal indicator. The trial was carried out in the Styx Valley of the Maniototo Plain in the South Island of New Zealand. Over an 8-year period dogs were treated monthly with bunamidine hydrochloride at about 25 mg/kg with little effect on the prevalence of T. hydatigena in lambs. The addition of niclosamide at 50 mg/kg for 1 year also had little effect. Eggs appeared to survive from one season to the next. Those shed prior to the lamb-rearing season gave rise to endemic-type patterns; whereas patent infections occurring during this period rapidly gave rise to an epidemic-type pattern or a ”cysticercosis storm”. In this 9-year period there were 16 ”cysticercosis storms” and all susceptible lambs were infected. These storms did not necessarily give rise to a similar prevalence on neighbouring farms, but may have contributed to the overall infective pattern. A similar situation occurred in the first year that nitroscanate at 100 mg/kg was introduced. During this 10-year period, arecoline surveillance of the dog population was undertaken in the remainder of the county and many dogs were found to harbour tapeworms. Both resident and introduced dogs may have contributed to the infective patterns in the Styx Valley. Treatment with nitroscanate was continued monthly in the Styx Valley and niclosamide was used in the remainder of the County for a further 3 years. There was a marked reduction in the age-specific prevalence and lambs on many farms were free from T. hydatigena at slaughter. However, one ”breakdown” occurred and this was almost certainly autochthonous. Comparisons with an earlier period when arecoline surveillance was used in the Styx Valley, indicate that the present evidence favours a drug-orientated treatment programme of the definitive host for the control of cysticercosis. However, ”breakdowns” caused by either autochthonous or itinerant sources have profound effects, since they involve all susceptible age-cohorts including those that have never been infected and those that have lost the immunity induced by an earlier infection. PMID:308408

Gemmell, M. A.

1978-01-01

123

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

124

The UKAEA defect detection trials  

International Nuclear Information System (INIS)

The UKAEA initiated Defect Detection Trials (DDT) in an attempt to confirm that currently available non-destructive testing techniques are capable of satisfactory detection and sizing of defects in a PWR pressure vessel. The paper outlines the scope of the trials and describes the test specimens employed. Other papers present the results reported by the various inspection teams. When the Trials were initiated in June 1980 there was a requirement that some results should be available by early 1982. This was to provide information in advance of the proposed UK-PWR Public Inquiry. The timescale had a significant influence on the scope of the trials and in the design of the test pieces. The principal objective was to assess the ability of selected NDT techniques to detect and correctly classify significant defects. These techniques were selected on the basis of the results obtained by alternative procedures in previous trials and in addition, techniques which were in such an advanced state of development that they could be considered as candidates for use in the first UK-PWR reactor. These selected NDT techniques were evaluated on specially prepared test pieces. The test pieces were made to simulate sections from a PWR pressure vessel and each incorporated particular defects, fabrication characteristics and geometric features considered to be of significance to reactor pressure vessel (RPV) inspection. (U.K.)

125

Can orthopedic trials change practice?  

Science.gov (United States)

Background and purpose The impact of large, randomized trials in orthopedic surgery on surgeons' preferences for a particular surgical approach remains unclear. We surveyed surgeons to assess whether they would change practice based upon results of a large, multicenter randomized controlled hip fracture trial. Methods We conducted a cross-sectional survey among International Hip Fracture Research Collaborative (IHFRC) surgeons and surgeons who were members of Arbeitsgemeinschaft fuer Osteosynthesefragen - Association for the Study of Internal Fixation (AO/ASIF) to determine the likelihood that they would change practice based on findings of a proposed large, multicenter randomized controlled trial (the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH) study). We asked surgeons their current preferences for the management of displaced femoral neck fractures and whether a trial that definitively revealed a substantial improvement in function and quality of life with no difference in risk of revision surgery was important and would cause them to change practice. Results Of 883 surgeons surveyed, 210 responded from IHFRC and 586 from AO/ASIF (a response rate of 90%). Most surgeons (61%) preferred hemiarthroplasty (HA) for treating displaced femoral neck fractures. 72% of responding surgeons believed that a substantial improvement in patient function with total hip arthroplasty (THA) and no adverse effects on revision surgery would be an important finding. Moreover, of 483 surgeons who preferred hemiarthroplasty, 62% would change their practice based upon the findings of the trial. Interpretation Large clinical trials in orthopedics are worthwhile endeavors, as they have the potential to change practice among surgeons. Surgeons seem willing to adopt alternative surgical approaches if the evidence is compelling and sound. PMID:20146638

Dijkman, Bernadette G; Kooistra, Bauke W; Pemberton, Julia; Sprague, Sheila; Bhandari, Mohit

2010-01-01

126

What Is a Clinical Trial?  

Medline Plus

Full Text Available ... So before signing this statement, be sure to learn all you can about the study. To help you make a decision, the National Cancer Institute offers publications explaining your disease as well as clinical trials. To receive such information, simply dial 1-800-4-CANCER.

127

Through trial & error to collusion  

OpenAIRE

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

1999-01-01

128

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 ...

129

DIABETES PREVENTION TRIAL TYPE 1  

Science.gov (United States)

The Diabetes Prevention Trial--Type 1 (DPT-1) is a nationwide study to see if we can prevent or delay type 1 diabetes, also known as insulin-dependent diabetes. Nine medical centers and more than 350 clinics in the United States and Canada are taking part in the study....

130

The Calgary Libraries Telidon Trial.  

Science.gov (United States)

The Calgary Libraries Telidon Trial involved four major libraries--Calgary Public, Mount Royal College, Southern Alberta Institute of Technology, and the University of Calgary--and resulted in videotex library services. This report discusses the beginning of the project, types of information input, conclusions of library-information providers, and…

Toombs, Michelle; Wilson, Bob

1982-01-01

131

Trials with a Strain Gauge.  

Science.gov (United States)

Describes an attempt to match the goals of the practical demonstration of the use of a strain gauge and the technical applications of science and responding to student questions in early trials, while keeping within the level of electronics in advanced physics. (Author/JRH)

Auty, Geoff

1996-01-01

132

Video - National Lung Screening Trial  

Science.gov (United States)

DCP Videos & Webinars National Lung Screening Trial: From Concept Design to Primary Result Presenter Richard Fagerstrom, PhD Air date 11/11/2011 YouTube embedded video: http://www.youtube-nocookie.com/embed/MnvATLr-smY

133

2012 Consortia for Early Phase Prevention Trials  

Science.gov (United States)

2012 DCP Consortia for Early Phase Prevention Trials 2012 Consortia for Early Phase Prevention Trials Standard Operating Procedures (SOP), Consortia 2012 (DOC, 517KB) (All SOP Documents with Table of Contents) DCP Acronym List, Consortia 2012

134

Why are clinical trials necessary in India?  

OpenAIRE

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

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

2014-01-01

135

Bayesian Adaptive Methods for Clinical Trials  

CERN Document Server

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

Berry, Scott M

2010-01-01

136

Lessons from maraviroc clinical trials.  

Science.gov (United States)

Evaluation of: Gulick RM, Lalezari J, Goodrich J et al. Maraviroc for previously treated patients with R5 HIV-1 infection. N. Engl. J. Med. 359, 1429-1441 (2008). Maraviroc is the first commercially available HIV chemokine receptor antagonist targeting HIV that utilizes the CCR5 chemokine receptor (R5 tropic). The Maraviroc versus Optimized Therapy in Viremic Antiretroviral Treatment-Experienced Patients (MOTIVATE) trials were two randomized, placebo-controlled studies designed to demonstrate the activity of maraviroc in triple-class-experienced HIV individuals, with a primary end point of viral load suppression at 48 weeks. Maraviroc outperformed the placebo plus optimized background (OBT) arm, and exhibited a favorable safety profile with low discontinuation rates, which equaled those of the placebo plus OBT group. The results of these trials led to maraviroc receiving regulatory approval for the treatment of HIV. PMID:21692669

Troia-Cancio, Paolo; Asmuth, David M

2011-06-01

137

Pediatric Obstructive Uropathy: Clinical Trials  

International Nuclear Information System (INIS)

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

138

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

139

The misguided ethics of crossover trials.  

Science.gov (United States)

Crossover is increasingly favored in trials of cancer therapies; even those that seek to establish the basic efficacy of novel drugs. Crossover is done in part for trial recruitment, but also out of a sense of doing the right thing-offering the investigational agent to more patients. In this paper, we argue that this ethical inclination-that crossover is a preferred trial choice-is misguided. In seeking to sate the desires of participants, we might undermine a trial's ability to answer a meaningful clinical question. When a trial is incapable of answering a question, it becomes unethical. Using a crossover strategy in oncology clinical trials can make trials less ethical, not more. PMID:24365533

Prasad, Vinay; Grady, Christine

2014-03-01

140

Market Trials of Irradiated Spices  

International Nuclear Information System (INIS)

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

141

Clinical Trials in Head Injury  

Science.gov (United States)

Traumatic brain injury (TBI) remains a major public health problem globally. In the United States the incidence of closed head injuries admitted to hospitals is conservatively estimated to be 200 per 100,000 population, and the incidence of penetrating head injury is estimated to be 12 per 100,000, the highest of any developed country in the world. This yields an approximate number of 500,000 new cases each year, a sizeable proportion of which demonstrate signficant long-term disabilities. Unfortunately, there is a paucity of proven therapies for this disease. For a variety of reasons, clinical trials for this condition have been difficult to design and perform. Despite promising pre-clinical data, most of the trials that have been performed in recent years have failed to demonstrate any significant improvement in outcomes. The reasons for these failures have not always been apparent and any insights gained were not always shared. It was therefore feared that we were running the risk of repeating our mistakes. Recognizing the importance of TBI, the National Institute of Neurological Disorders and Stroke (NINDS) sponsored a workshop that brought together experts from clinical, research, and pharmaceutical backgrounds. This workshop proved to be very informative and yielded many insights into previous and future TBI trials. This paper is an attempt to summarize the key points made at the workshop. It is hoped that these lessons will enhance the planning and design of future efforts in this important field of research. PMID:12042091

NARAYAN, RAJ K.; MICHEL, MARY ELLEN; Ansell, Beth; Baethmann, Alex; Biegon, Anat; Bracken, Michael B.; Bullock, M. Ross; Choi, Sung C.; Clifton, Guy L.; Contant, Charles F.; Coplin, William M.; Dietrich, W. Dalton; Ghajar, Jamshid; Grady, Sean M.; Grossman, Robert G.; Hall, Edward D.; Heetderks, William; Hovda, David A.; Jallo, Jack; Katz, Russell L.; Knoller, Nachshon; Kochanek, Patrick M.; Maas, Andrew I.; Majde, Jeannine; Marion, Donald W.; Marmarou, Anthony; Marshall, Lawrence F.; McIntosh, Tracy K.; Miller, Emmy; Mohberg, Noel; Muizelaar, J. Paul; Pitts, Lawrence H.; Quinn, Peter; Riesenfeld, Gad; Robertson, Claudia S.; Strauss, Kenneth I.; Teasdale, Graham; Temkin, Nancy; Tuma, Ronald; Wade, Charles; Walker, Michael D.; Weinrich, Michael; Whyte, John; Wilberger, Jack; Young, A. Byron; Yurkewicz, Lorraine

2006-01-01

142

Efficacy and safety of cinnarizine in the prophylaxis of migraine headaches in children: an open, randomized comparative trial with propranolol.  

Science.gov (United States)

Migraine headaches are common in children. Early diagnosis and appropriate interventions are mandatory to prevent decades of suffering and diminished quality of life. There is need for data regarding the efficacy and safety of prophylactic agents in children with migraine; therefore, we designed a randomized clinical trial to compare the efficacy and safety of cinnarizine with that of a well-known prophylactic agent (propranolol) in the prophylaxis of pediatric migraine headache. A total of 120 patients aged between 6 and 17 years were recruited and 113 patients succeeded in completing all phases of the trial. Of them, 57 patients were given cinnarizine, and propranolol was administered in 56 patients. Reduction in headache frequency was the main response to treatment. Cinnarizine reduced the baseline headache frequency by more than 50% in 74.6% of patients and the mean headache frequency per month was reduced from 11.851 ± 0.739 (mean ± SEM) to 3.358 ± 0.739 (mean ± SEM) attacks per month (P cinnarizine appeared thus as effective as propranolol and safe for the prophylaxis of migraine in children, but this remains to be confirmed in a double-blind placebo-controlled trial. PMID:22427290

Togha, Mansoureh; Malamiri, Reza Azizi; Rashidi-Ranjbar, Neda; Asa, Solmaz; Mahvelati, Farhad; Ashrafi, Mahmoud Reza

2012-03-01

143

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

144

Maximizing scientific knowledge from randomized clinical trials  

DEFF Research Database (Denmark)

Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were discussed by a group of trialists. This review focuses on the arguments for conducting posttrial database studies and presents examples of studies in which posttrial knowledge generation has been substantial. Possible strategies to ensure successful trial database or biobank generation are discussed, in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists is outlined.

Gustafsson, Finn; Atar, Dan

2010-01-01

145

Lessons from the SYNTAX trial  

OpenAIRE

Despite the fact that CABG is the standard of care for patients with multivessel coronary arteries and/or left main stem stenosis, PCI has become a rival to CABG in patients with multivessel coronary artery disease or left main disease. However, the need for repeat revascularization, in-stent stenosis and thrombosis remain the achilis heal of PCI. SYNTAX trial randomized patients with left main disease and/or three-vessel disease to PCI with TAXus stent or CABG with the concept that PCI is no...

Alamri, Hussein S.; Alotaiby, Mohammed; Almoghairi, Abdulrahman; El Oakley, Rieda M.

2010-01-01

146

Statistical aspects of clinical trials  

International Nuclear Information System (INIS)

A basic understanding of the various disciplines involved in the planning and conducting of a clinical trial is a prerequisite for a fruitful result. This paper explains some of the statistical ideas and vocabulary used in the process of documenting the X-ray contrast medium iopentol Nycomed AS, Oslo, Norway). Topics discussed include the concepts of the significance level, the null-value, and the corresponding confidence interval, in controlled situations and in exploratory analysis; and a discussion of parametric vs. non-parametric methods. (author). 8 refs.; 2 figs.; 1 tab

147

Melanoma vaccines: trials and tribulations  

Directory of Open Access Journals (Sweden)

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

Dillman RO

2013-10-01

148

Calibration trials with multibeam sonars  

Science.gov (United States)

A series of calibration trials have been performed with several multibeam sonars by means of the standard-target method. These have included multiple units of the Simrad SM2000 Multibeam Echo Sounder operating at 90 or 200 kHz, with external transmitter in each case. The principal measurements have been of the full two-dimensional directivity characteristics of the main lobes. Issues of sensitivity, linearity, dynamic range, and near-field effects have also been studied. [Work supported by NSF Grant No. OCE-0002664.

Chu, Dezhang; Foote, Kenneth G.; Baldwin, Kenneth C.; Mayer, Larry A.; McLeod, Andrew; Hufnagle, Lawrence C.; Jech, J. Michael; Michaels, William

2003-10-01

149

Learning by trial and error  

OpenAIRE

A person learns by trial and error if he occasionally tries out new strategies, rejecting choices that are “erroneous” in the sense that they do not lead to higher payoffs. In a game, however, strategies can become erroneous due to a change of behavior by someone else. Such passive errors may also trigger a search for new and better strategies, but the nature of the search is different than when a player is actively engaged in experimentation. This paper introduces a simple version of thi...

Prof Hobart Young

2008-01-01

150

RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH.  

Science.gov (United States)

This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as "market exclusivity" and in Europe as "data exclusivity," these rights prohibit would-be generic producers from obtaining regulatory approval based on the original producers' undisclosed test data. Market and data exclusivity is codified in US and European domestic law as well as the North American Free Trade Agreement (NAFTA) and, to a lesser degree, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Market and data exclusivity is binding an increasing number of developing countries via Free Trade Agreements (FTAs), which hinder developing countries from manufacturing generic drugs. At a minimum, negotiators should replace the norm of exclusive control over data with a liability rule, or take and pay rule, in which generic manufacturers can use original manufacturers' clinical trial data in exchange for reasonable compensation. A more fundamental solution requires questioning the status quo of proprietary clinical trial data. The conventional wisdom is that market and data exclusivity, and drug developers' consequent ability to limit competition from generics above and beyond patent protection, are a necessary incentive for drug developers to fund ever more expensive clinical trials. Clinical trial data, however, are public goods that will be undersupplied and over protected so long as private actors provide them. Moreover, manufacturers have an incentive to present clinical trial data so that they support regulatory approval at the expense of public health. Although liability rules are better than the status quo, they would not resolve the problem of treating a public good as proprietary. Governments should thus oversee and fund clinical trials as the public good that they are. Clinical tests should be awarded to the most qualified scientists through a competitive process, financed in part with the decrease in drug costs to governmental health care programs and in part with drug developers' contributions, selected to maximize social benefit, and made global via intergovernmental bodies to maximize social return. This would reduce the cost of redundant investigations to the global public health system, lower supply costs to drug consumers, and lower the breakeven point for investment in research to discover new drugs. PMID:20431702

Reichman, Jerome H

2009-01-01

151

RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH  

Science.gov (United States)

This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as “market exclusivity” and in Europe as “data exclusivity,” these rights prohibit would-be generic producers from obtaining regulatory approval based on the original producers’ undisclosed test data. Market and data exclusivity is codified in US and European domestic law as well as the North American Free Trade Agreement (NAFTA) and, to a lesser degree, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Market and data exclusivity is binding an increasing number of developing countries via Free Trade Agreements (FTAs), which hinder developing countries from manufacturing generic drugs. At a minimum, negotiators should replace the norm of exclusive control over data with a liability rule, or take and pay rule, in which generic manufacturers can use original manufacturers’ clinical trial data in exchange for reasonable compensation. A more fundamental solution requires questioning the status quo of proprietary clinical trial data. The conventional wisdom is that market and data exclusivity, and drug developers’ consequent ability to limit competition from generics above and beyond patent protection, are a necessary incentive for drug developers to fund ever more expensive clinical trials. Clinical trial data, however, are public goods that will be undersupplied and over protected so long as private actors provide them. Moreover, manufacturers have an incentive to present clinical trial data so that they support regulatory approval at the expense of public health. Although liability rules are better than the status quo, they would not resolve the problem of treating a public good as proprietary. Governments should thus oversee and fund clinical trials as the public good that they are. Clinical tests should be awarded to the most qualified scientists through a competitive process, financed in part with the decrease in drug costs to governmental health care programs and in part with drug developers’ contributions, selected to maximize social benefit, and made global via intergovernmental bodies to maximize social return. This would reduce the cost of redundant investigations to the global public health system, lower supply costs to drug consumers, and lower the breakeven point for investment in research to discover new drugs. PMID:20431702

REICHMAN, JEROME H.

2009-01-01

152

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

153

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

Science.gov (United States)

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

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

2012-01-01

154

[Hazard, risk and harm in clinical trials].  

Science.gov (United States)

Investigators and other stakeholders involved in clinical trials are not aware about all possible harms, hazards and risks related to this activity. Different categories of harms may occur during clinical trials like: physical (injury, illness, pain, suffering, or discomfort), psychological, social, economic, legal, dignitary and relational. Clinical trial participants are not the only one stakeholder exposed to different types of hazards. Among others the most important are: investigators, sponsors, centers (where clinical trials are conducted), contract research organizations and bioethics committees. Regardless of multiple hazards, substantial harms are discovered relatively rare. This situation could be explained by a small number of high risk potential clinical trials and low social awareness about different types of possible harms. Proper education should ameliorate our knowledge about hazards, risks and harms in clinical trials. PMID:18942326

Czarkowski, Marek

2008-08-01

155

Innovative clinical trial design for pediatric therapeutics  

OpenAIRE

Until approximately 15 years ago, sponsors rarely included children in the development of therapeutics. US and European legislation has resulted in an increase in the number of pediatric trials and specific label changes and dosing recommendations, although infants remain an understudied group. The lack of clinical trials in children is partly due to specific challenges in conducting trials in this patient population. Therapeutics in special populations, including premature infants, obese chi...

Laughon, Matthew M.; Benjamin, Daniel K.; Capparelli, Edmund V.; Kearns, Gregory L.; Berezny, Katherine; Paul, Ian M.; Wade, Kelly; Barrett, Jeff; Smith, Phillip Brian; Cohen-wolkowiez, Michael

2011-01-01

156

Clinical Trials for Supportive and Palliative Care  

Science.gov (United States)

Clinical trials for supportive and palliative care explore ways to improve the comfort and quality of life of cancer patients and cancer survivors. These trials study ways to help people who are experiencing symptoms related to cancer and its treatment, such as nausea, pain, weight loss, sleep disorders, and depression. Some of these trials also look at nutrition, group therapy, and other interventions to help cancer patients and survivors.

157

Traversing the Translational Trail for Trials  

OpenAIRE

The principles of spinal cord injury clinical trial programs are briefly reviewed as one example of the challenge faced by most human studies of neurologically directed therapeutic interventions, including rehabilitation strategies. Different trial protocols are reviewed, as are inclusion/exclusion criteria for study subjects, the choice of clinical endpoints, and the statistical approaches that might be used in a trial program. Potential factors that might confound the accurate interpretatio...

Steeves, John D.; Kramer, John L. K.; Zariffa, Jose

2012-01-01

158

Potential bias in ophthalmic pharmaceutical clinical trials  

OpenAIRE

Paul VarnerJohn J Pershing Veterans’ Administration Medical Center, Poplar Bluff, Missouri, USAAbstract: To make clinicians aware of potential sources of error in ophthalmic pharmaceutical clinical trials that can lead to erroneous interpretation of results, a critical review of the study design of various pharmaceutical ophthalmic clinical trials was completed. Discrepancies as a result of study shortcomings may explain observed differences between reported ophthalmic trial data an...

Paul Varner

2008-01-01

159

Logistics and management of clinical trials.  

OpenAIRE

This chapter is concerned with some of the more mundane aspects of the day to day design, planning, documentation, and management of clinical trials, rather than with the finer points of trial design which are dealt with in detail elsewhere. The points considered here, taken individually, seem obvious and trivial but it is hoped that some may be helpful in obtaining the maximum return for the work invested in running a trial.

Greenberg, G.

1982-01-01

160

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.

2007-06-01

161

Intracellular Signaling Transduction Pathways Triggered by a Well-Known Anti-GHR Monoclonal Antibody, Mab263, in Vitro and in Vivo  

OpenAIRE

A series of studies have reported that monoclonal antibody 263 (Mab263), a monoclonal antibody against the growth hormone receptor (GHR), acts as an agonist in vitro and in vivo. However, the intracellular signaling pathways triggered by Mab263 have not yet been delineated. Therefore, we examined the intracellular signaling pathways induced by Mab263 in vivo and in vitro in the present study. The results show that this antibody activated janus kinase 2 (JAK2), signal transducer and activator...

Hainan Lan; Wei Li; Honglong Jiang; Yanhong Yang; Xin Zheng

2014-01-01

162

An outline of a programme investigating particle creation by a black hole with the help of well-known quantum-field effects in flat spacetime  

International Nuclear Information System (INIS)

A programme investigating particle creation in a black hole by the application of flat-spacetime, quantum-field results is carried out. The utilization of the Casimir-effect results and those of accelerated mirrors reveals that a black hole should produce blackbody radiation that exactly coincides with Hawking's. An important difference between the vacuum stress-tensors of scalar and electromagnetic fields is found. The blackbody spectrum of Hawking radiation is due to the interaction of the radiation with a ''cavity'' formed by the potential baerier of the gravitational field. The consideration of the potential-baerier finite conductivity makes it possible to eliminate the pathology of the vacuum stress-tensor on the horizon and to reveal that the blackbody radiation should be created in the whole region (3M, infinity). (author)

163

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

Science.gov (United States)

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

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

2014-11-01

164

The First Order Absolute Central Moment as an Edge-Detector in Cardiovascular Imaging: A Comparison with Two Well-Known Edge-Detectors  

OpenAIRE

Cardiovascular imaging usually requires the detection and the localization of contours. Many mathematical operators have been studied to improve the performances of the edge detection algorithms but the most frequently used operators in literature remain the Laplacian of Gaussian (LoG) and the gradient of Gaussian (GoG). Recently, a new mathematical operator, which has been obtained from the generalization of the first absolute central moment, has been proposed. The aim of this paper is to co...

Faita, Francesco; Gemignani, Vincenzo; Giannoni, Massimo; Benassi, Antonio; Ferdeghini, Ezio Maria; Demi, Marcello

2005-01-01

165

Assessing the suitability and safety of a well-known bud-galling wasp, Trichilogaster acaciaelongifoliae, for biological control of Acacia longifolia in Portugal  

OpenAIRE

Acacia longifolia is a widespread invasive plant species in Portugal. In South Africa, it is controlled by a bud-galling wasp, Trichilogaster acaciaelongifoliae, which could also be used in Portugal. Biological control of invasive alien plants has received little consideration anywhere in Europe and has never been attempted in Portugal. The lack of a suitably-large quarantine facility necessitated the use of a novel approach to test non-target species in Portugal. Mature T. acaciaelongifoliae...

Marchante, H.; Freitas, H.; Hoffmann, J. H.

2011-01-01

166

Thiabendazole, a well-known antifungal drug, exhibits anti-metastatic melanoma B16F10 activity via inhibiting VEGF expression and inducing apoptosis.  

Science.gov (United States)

Thiabendazole, an orally available antifungal drug, has been used in clinical practice for 40 years. Previous studies indicated its potential in inhibiting angiogenesis in both animal models and in human cells. Malignant melanoma is associated with angiogenesis and it is unknown whether thiabendazole is effective for malignant melanoma or not. In our research, the effects of thiabendazole on the proliferation of the murine metastatic melanoma cell line B16F10 in vitro and in vivo and the molecular mechanism were investigated. Assay of cell viability, chick embryo chorioallantoic membrane assay, quantitative real-time PCR, Western blot, wound healing assay, annexin V/propidium iodide (AV/PI) assay and B16F10-xenograft model were applied to elucidate the mechanism of thiabendazole on B16F10 cells. Thiabendazole inhibited B16F10 proliferation in vitro in a dose- and time-dependent manner with an IC50 of 532.4 +/- 32.6, 322.9 +/- 28.9, 238.5 +/- 19.8 microM at 24, 48, and 72 h, respectively. Moreover, thiabendazole inhibited the angiogenesis and the migration of B16F10 cells in vitro. Furthermore, thiabendazole restrained transcription and translation of the VEGF gene in B16F10 in vitro, and the apoptotic percentage of B16F10 cells was increased after exposure to thiabendazole. Finally, in the B16F10-bearing mice model, thiabendazole significantly suppressed tumor growth with inhibitory rates of 16.5%, 35.4% and 48.7% at the treatment of thiabendazole 20, 40 and 80 mg/kg, respectively. These results further indicated that thiabendazole may be a potential candidate for the treatment of malignant melanoma. PMID:24400443

Zhang, Jinnan; Zhao, Conghai; Gao, Yufei; Jiang, Yang; Liang, Huaxin; Zhao, Gang

2013-12-01

167

MD Anderson study finds patients with aberrations in two genes respond better to drugs blocking a well-known cancer pathway  

Science.gov (United States)

Cancer patients with mutations or variations in two genes -– PIK3CA and PTEN -– who have failed to respond to several standard treatments, respond significantly better to anti-cancer drugs that inhibit these genes' pathways of action, according to research from the MD Anderson Cancer Center presented at the 24th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Dublin, Ireland.

168

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

OpenAIRE

"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 co...

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

2010-01-01

169

A well-known lesion in an unusual location: infantile myofibroma of the eyelid: a case report and review of literature.  

Science.gov (United States)

Myofibroma is a neoplasia of myofibroblasts that can be solitary or multiple and it is found most commonly in the head & neck region including scalp, forehead, parotid region and oral cavity. In the eyelid it is rarely reported. It has a benign course in the solitary form and fatal in its multiple form. A 4 month male infant referred to Farabi hospital -the referral center for eye diseases- with a 2 month history of a mass in his eyelid with gradual enlargement with no other complaints. The only abnormal physical finding was a 2.5 cm mass in the eyelid. This mass was excised and sent to the hospital pathology laboratory. When confronting a spindle cell lesion with a nodular or multinodular growth pattern which appears biphasic due to alteration of light and dark staining areas, the surgical pathologist should think to the possibility of myofibroma. Its pattern of growth and architecture rules out the other differential diagnoses like nodular fasciitis, fibrous histiocytoma, infantile fibromatosis, and peripheral primitive neuroectodermal tumor, mesenchymal chondrosarcoma, malignant hemangiopericytoma, juvenile fibrosarcoma and poorly differentiated synovial sarcoma. In difficult cases immunohistochemical staining is helpful that is Vimentin & Actin positivity & Desmin, CK, EMA & S100 negativity. PMID:21287484

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

2010-01-01

170

As newspapers continue to face hard times, some look back to the days of the well-known columnists who chronicled their cities  

Science.gov (United States)

Paper Cuts: Diligently plotting the decline of US newspapershttp://www.guardian.co.uk/media/pda/2009/apr/06/newspapers-downturnTweaking the Cable Model, to Avoid Newspapers' Fatehttp://bits.blogs.nytimes.com/2009/04/06/tweaking-the-cable-model-to-avoid-newspapers-fate/Herb Caen and his cityhttp://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/04/04/LV5016MC6J.DTLCaen on capital punishmenthttp://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/03/31/DD61167SUF.DTLMike Roykohttp://www.suntimes.com/news/royko/index.htmlFor the Love of Mikehttp://www.press.uchicago.edu/Misc/Chicago/730735.htmlEmmett Watsonhttp://www.seattlepi.com/local/22773_watson12.shtmlThe late 1990s and early 2000s were hard times for those who grew up reading daily newspapers in cities like Chicago, Seattle, and San Francisco. During these years, the acerbic and insightful commentaries of Mike Royko at the Chicago Tribune, Herb Caen at the San Francisco Chronicle, and Emmett Watson at the Seattle Times disappeared from the paper as all three gentlemen passed away during this period. These men might have been a bit disturbed by a number of recent trends in the newspaper business, including the recent demise of the print version of the once venerable Seattle Post-Intelligencer and the bankruptcy problems faced by the Chicago Sun-Times media group. As Carl Nolte, a Chronicle staff writer, noted in a column this week, "Herb Caen was the voice, the conscience, the civic maestro of a San Francisco that was part reality, part a myth of his own creation." Technological innovations have certainly increased the number of viewpoints available to the average reader, but it remains to be seen whether any of them will have the staying power of these three creative individuals.The first link will take users to a very compelling entry on the Digital Content weblog created by The Guardian newspaper. This particular entry includes a link to the Paper Cuts website, which details the decline of the newspaper industry in the United States during the past year. The second link will whisk users away to a post on the New York Times "Bits" weblog, which talks about how the cable industry may address the migration of viewers to the Internet. Moving on, the third link leads to the recent piece on Caen written by Carl Nolte for the San Francisco Chronicle. The fourth link leads to a column that Caen wrote about capital punishment on May 1, 1960. The fifth link leads to a series of columns written by Mike Royko on such subjects as the Chicago Cubs and Mayor Richard J. Daley. The sixth link is in the same vein, as it offers a clutch of additional columns written by Royko. Finally, the last link leads to a piece by John Hahn of the Seattle Post-Intelligencer commemorating noted journalist and one-time minor league ballplayer, Emmett Watson.

Grinnell, Max

2009-04-10

171

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

172

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

Directory of Open Access Journals (Sweden)

Full Text Available "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 complaints. The only abnormal physical finding was a 2.5 cm mass in the eyelid. This mass was excised and sent to the hospital pathology laboratory. When confronting a spindle cell lesion with a nodular or multinodular growth pattern which appears biphasic due to alteration of light and dark staining areas, the surgical pathologist should think to the possibility of myofibroma. Its pattern of growth and architecture rules out the other differential diagnoses like nodular fasciitis, fibrous histiocytoma, infantile fibromatosis, and peripheral primitive neuroectodermal tumor, mesenchymal chondrosarcoma, malignant hemangiopericytoma, juvenile fibrosarcoma and poorly differentiated synovial sarcoma. In difficult cases immunohistochemical staining is helpful that is Vimentin & Actin positivity & Desmin, CK, EMA & S100 negativity.

Fahimeh Asadi Amoli

2010-11-01

173

Kudoa trifolia sp. n. - molecular phylogeny suggests a new spore morphology and unusual tissue location for a well-known genus.  

Science.gov (United States)

A new species of myxozoan, Kudoa trifolia sp. n., was found in various organs of the golden grey mullet, Liza aurata (Risso), and the thinlip mullet, L. ramada (Risso), from the western Mediterranean. Spores developed in subspherical plasmodia of 0.28-1 mm diameter within connective tissue, predominantly in the spleen, the outer wall of the gall bladder and the gut, the mesenteries and occasionally also in the gills. The spores of K. trifolia differ from the commonly known shape of Kudoa by considerable enlargement of one of the four valve cells, thus forming a 'spore body', which contains the major part of the binucleate sporoplasm. Scanning electron microscopy of the spores revealed the presence of grape-like appendages, which occur in bundles terminally on the valve cells. Phylogenetic analysis based on the 18S rDNA sequence of K. trifolia showed that this species is deeply embedded in the genus Kudoa despite its aberrant morphology and host tissue location. This suggests important amendments to the morphological diagnosis of the genus Kudoa. PMID:17169107

Holzer, A S; Blasco-Costa, I; Sarabeev, V L; Ovcharenko, M O; Balbuena, J A

2006-12-01

174

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

DEFF Research Database (Denmark)

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

Licht, R W; Gouliaev, G

1997-01-01

175

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.

176

Inactive trials of transport systems  

International Nuclear Information System (INIS)

The design and manufacture of a mock-up of a crate handling and size reduction (CHSR) facility, an experimental programme on the evaluation of a commercial air-transporter, and the selection, manufacture and commissioning trials of an integrated conveyor system for transporting crated waste into and within the mock-up facility, are considered. The mock-up facility was used for the test programme on the air-transporter and conveyor system. The air-transporter was considered suitable for transporting waste on the metal floor in the main dismantling area of the CHSR facility because it can tolerate asymmetric loading, the exhaust air flow liberated from the air-pads is low and it has excellent manoeuvrability. Commissioning trials were carried out on a commercial conveyor system consisting of unpowered rollers in the reception area, a powered slatted conveyor in the air-lock and an unpowered roller table placed on the air-transporter in the working area. It was demonstrated that a large asymmetrically loaded wooden crate can be transported into and within the facility by this method. Further design and experimental work necessary before the system can be used for remote operation is discussed. (author)

177

Adaptive designs for noninferiority trials.  

Science.gov (United States)

A method of testing for noninferiority followed by testing for superiority in an adaptive group sequential design is presented. The method permits a data-dependent increase in sample size without any inflation of type-1 error. Closed-form expressions for computing conditional power and the sample size required to achieve any desired conditional power are derived. A new statistical method for performing inference on the primary efficacy parameter is derived. The method is used to obtain the p-value, median-unbiased point estimate and confidence interval for the efficacy parameter. For normal endpoints with known variance, the coverage of the confidence interval is exact. In other settings, the coverage is exact for large samples. An illustrative example is provided in which the methods of testing and estimation are applied to an actual clinical trial of acute bacterial skin and skin-structure infection. The operating characteristics of the trial are obtained by simulation and demonstrate that the type-1 error is preserved, the point estimate is median unbiased, and the confidence interval provides exact coverage up to Monte Carlo accuracy. PMID:23494872

Gao, Ping; Liu, Lingyun; Mehta, Cyrus

2013-05-01

178

Domestic and international trials, 1700-2000: The trial in history, vol. II  

OpenAIRE

How does the trial function? What are the tools, in terms of legal principle, scientific knowledge, social norms, and political practice, which underpin this most important decision-making process? This collection of nine essays by an international group of scholars explores these crucial questions. Focusing both on English criminal, military, and parliamentary trials, and upon national and international trials for war crimes, this book illuminates the diverse forces that have shaped trials d...

Melikan, R. A.

2003-01-01

179

Recruitment, Retention, and Blinding in Clinical Trials  

OpenAIRE

The recruitment and retention of participants and the blinding of participants, health care providers, and data collectors present challenges for clinical trial investigators. This article reviews challenges and alternative strategies associated with these three important clinical trial activities. Common recruiting pitfalls, including low sample size, unfriendly study designs, suboptimal testing locations, and untimely recruitment are discussed together with strategies for overcoming these b...

Page, Stephen J.; Persch, Andrew C.

2013-01-01

180

Update on Randomized Controlled Clinical trial data  

OpenAIRE

MERCK SYMPOSIUM forum room Tibolone, an update on observational studies and clinical trials including 13.000 patients Chair: Leon Speroff 1. Chiara Benedetto (IT) - Update on Randomized Controlled Clinical trial data 2. Samy Suissa (CA) - Update on Observational Study data 3. Leon Speroff (US) - Update on Clinical Recommendations and Practical Guidelines

Benedetto, Chiara

2010-01-01

181

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

182

Safety methodology in pediatric psychopharmacology trials.  

Science.gov (United States)

In recent years, there has been an increase in pediatric clinical trials as the result of an identified need for greater research with this population. Given the potential risks, and the vulnerability of the population, there has also been an identified need for greater safety elicitation and monitoring in pediatric psychopharmacology trials, for example, through the use of a data and safety monitoring board (DSMB). However, research indicates that pediatric trials and psychiatric trials are less likely to use a DSMB. The rationale for the current study was to determine what safety methodologies have been reported in pediatric psychopharmacology trials over the past 10 years. A literature review was conducted of all pediatric psychopharmacology trials published since 2001. Results indicated that the most common elicitation method was collecting laboratory information and vital signs. Six percent of trials solely relied on spontaneous reporting of adverse events, and only 11.8% reported using a DSMB. These results suggest that elicitation methods and use of DSMBs are still low. Practical considerations, affected stakeholders, and barriers are discussed. Recommendations for moving forward include the use of multiple elicitation methods and automatic requirement of a DSMB for pediatric psychopharmacology trials, required completion of a standardized safety reporting form, and engaging multiple interested parties in these processes. PMID:23607408

Yuill, Kathryn; Carandang, Carlo

2013-04-01

183

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

184

The Mycotic Ulcer Treatment Trial  

Science.gov (United States)

Objective To compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis. Methods This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. Main Outcome Measures The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. Results A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycin-treated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=?0.18 logMAR; 95% CI, ?0.30 to ?0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=?0.41 logMAR; 95% CI, ?0.61 to ?0.20; PNatamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. Application to Clinical Practice Voriconazole should not be used as monotherapy in filamentous keratitis. Trial Registration clinicaltrials.gov Identifier: NCT00996736 PMID:23710492

Prajna, N. Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Prajna, Lalitha; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E.; Ray, Kathryn J.; Zegans, Michael E.; McLeod, Stephen D.; Porco, Travis C.; Acharya, Nisha R.; Lietman, Thomas M.

2013-01-01

185

Why are clinical trials necessary in India?  

Science.gov (United States)

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

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

2014-04-01

186

NIH-Sponsored HIV Vaccine Trial Launches in South Africa  

Science.gov (United States)

... 2015 NIH-sponsored HIV vaccine trial launches in South Africa Early-stage trial aims to build on RV144 ... trial called HVTN 100 has been launched in South Africa to study an investigational HIV vaccine regimen for ...

187

Clinical trial registration in oral health journals.  

Science.gov (United States)

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

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

2015-03-01

188

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

Directory of Open Access Journals (Sweden)

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

Scardino Peter T

2009-03-01

189

Provenance trials of larch in Siberia  

Energy Technology Data Exchange (ETDEWEB)

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

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

1995-12-31

190

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

191

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

Science.gov (United States)

An appropriately equipped and staffed Phase I unit is critical for smooth conduct of a first-in-man clinical trial. The first-in-man prophylactic vaccine trial(s) requires basic infrastructure of clinical trial site, experienced and dedicated site staff and healthy adults as volunteers. The facility should have access to equipment, emergency services, laboratory, pharmacy and archiving. In terms of design, infrastructure, workflow and manpower, a Phase I unit for testing a novel vaccine or drug are quite similar. However, there are some important attributes, which should be taken into consideration, while performing pre-trial site selection for conducting phase I trial with a new or novel vaccine. PMID:25878951

Mehta, Shantanu; Goyal, Vishal; Singh, Kavita

2015-01-01

192

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

193

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

194

Reovirus: Rationale and clinical trial update.  

Science.gov (United States)

Early clinical trials of reovirus administered via the intratumoral or intravenous routes in patients with advanced cancers established the safety profile and MTD of these agents. Reovirus is an orphan virus and is the cause of a well-documented subclinical syndrome. Preclinical evidence of the novel mechanisms of anticancer activity of reovirus provided the rationale for advancing this agent into clinical trials. Preclinical studies have also defined the specificity of the antitumor activity of reovirus, and also its efficacy in combination with cytotoxic chemotherapies and immunosuppressants. Early clinical trials of combinations of the injectable oncolytic reovirus therapy Reolysin (Oncolytics Biotech Inc) plus cytotoxic chemotherapies are ongoing, as are phase II trials of Reolysin as a single agent for the treatment of specific tumor types. PMID:19806501

Lal, Rohit; Harris, Dean; Postel-Vinay, Sophie; de Bono, Johann

2009-10-01

195

Clinical Trials: Key to Medical Progress  

Science.gov (United States)

... basic kinds of trials: observational and interventional. An observational study is done to find out what causes a ... Medicine (NLM), which manages the Web site. "With patients taking an increasingly ... studies on everything from Alzheimer's disease to zinc supplements. ...

196

TREATMENT OF LEAD EXPOSED CHILDREN TRIAL  

Science.gov (United States)

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

197

Registration of Trials in Clinicaltrials.gov  

Science.gov (United States)

Meetings & Events Investigators' - Site Coordinators' Opportunity for Research Excellence (I-SCORE) Workshop March 20-21, 2014 Poster Presentations – Full List « Previous | Next »   Registration of Trials in Clinicaltrials.gov Anne Tompkins, Troy

198

Clinical Trials and Translational Research Advisory Committee  

Science.gov (United States)

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

199

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

OpenAIRE

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 = 2...

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

2005-01-01

200

Incidental genetic findings in randomized clinical trials: recommendations from the Genomics and Randomized Trials Network (GARNET)  

OpenAIRE

Recommendations and guidance on how to handle the return of genetic results to patients have offered limited insight into how to approach incidental genetic findings in the context of clinical trials. This paper provides the Genomics and Randomized Trials Network (GARNET) recommendations on incidental genetic findings in the context of clinical trials, and discusses the ethical and practical issues considered in formulating our recommendations. There are arguments in support of as well as aga...

Bookman, Ebony B.; Din-lovinescu, Corina; Worrall, Bradford B.; Manolio, Teri A.; Bennett, Siiri N.; Laurie, Cathy; Mirel, Daniel B.; Doheny, Kimberly F.; Anderson, Garnet L.; Wehr, Kate; Weinshilboum, Richard; Chen, Donna T.

2013-01-01

201

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

202

Marketing and clinical trials: a case study  

OpenAIRE

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...

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

2007-01-01

203

Consumers’ Trial Buying Process of Service Innovation.  

OpenAIRE

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

204

Quality of clinical trials: A moving target  

OpenAIRE

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

205

The Hawthorne Effect: a randomised, controlled trial  

OpenAIRE

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

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

2007-01-01

206

Legal aspects of clinical trials in Israel.  

Science.gov (United States)

Clinical trials were mainly the concern of medical ethics until the first code on this subject was laid down in a judgment given by a military tribunal in Nuremberg in 1947. In 1964 the World Medical Association adopted the Declaration of Helsinki, which was revised in 1975, regarding clinical trials and research. The Declaration of Helsinki and the developments in the pharmacological and pharmaceutical sciences led to legislation regarding clinical trials and human experimentation. In Israel it is forbidden to use any drug that is not registered. In order to register a drug, evidence of quality, safety and efficacy is necessary, and the means by which these factors are proved is the clinical trial, which demands appropriate legislation. Developments in various medical fields, as well as new treatment techniques, brought about the need for more comprehensive legislation on experimentation on human beings and embryos. In Israel, this field is covered by two enactments, the first on drugs and the second on any other experimentation on human beings. However, these enactments are frame laws, which lay down the rule that no clinical trial may be carried out without the prior approval of the Ministry of Health. They also state the minimum conditions to be met, and provide the Ministry with the authority to add any conditions at any time, as well as the right to stop the trial. The Declaration of Helsinki serves as the minimal legal basis for clinical trials. Some legal problems relating to the clinical trial remain unsolved and are left to the discretion of the Ministry of Health. The author makes some observations and suggestions with regard to matters of consent, incompetents as subjects, the right of withdrawal, and the power of the Ministry. PMID:6862852

Frenkel, D A

1983-05-01

207

Better therapeutic trials in ovarian cancer.  

Science.gov (United States)

The Ovarian Task Force of the Gynecologic Cancer Steering Committee convened a clinical trials planning meeting on October 28-29, 2011, with the goals to identify key tumor types, associated molecular pathways, and biomarkers for targeted drug intervention; review strategies to improve early-phase screening, therapeutic evaluation, and comparison of new agents; and optimize design of randomized trials in response to an evolving landscape of scientific, regulatory, and funding priorities. The meeting was attended by international clinical and translational investigators, pharmaceutical industry representatives, government regulators, and patient advocates. Panel discussions focused on disease types, early-phase trials, and randomized trials. A manuscript team summarized the discussions and assisted with formulating key recommendations. A more integrated and efficient approach for screening new agents using smaller selective randomized trials in specific disease-type settings was endorsed, together with collaborative funding models between industry and the evolving national clinical trials network, as well as efforts to enhance public awareness and study enrollment through advocacy. PMID:24627272

Bookman, Michael A; Gilks, C Blake; Kohn, Elise C; Kaplan, Karen O; Huntsman, David; Aghajanian, Carol; Birrer, Michael J; Ledermann, Jonathan A; Oza, Amit M; Swenerton, Kenneth D

2014-04-01

208

Talking About Trials: Overcoming Bottlenecks in Clinical Communication  

Science.gov (United States)

Participation in clinical trials by adult patients is dismally low. No one knows how many patients are offered the opportunity to enroll in trials. NCI researchers are studying how patients hear about trials, whether they discuss enrollment with their providers, and the roles they play in deciding to participate in a trial.

209

The International "Trial of the 20th Century": Nuremberg.  

Science.gov (United States)

Considers the Nuremberg trials to be the "Trial of the Century." Highlights the series of 13 trials in which Nazi leaders, officials, judges, and others were tried, and most convicted, for war crimes. Relates that these trials had far-reaching effects in that they showed that moral obligations transcend national boundaries. (CMK)

Chemerinsky, Erwin

1999-01-01

210

SPIRIT 2013 statement: defining standard protocol items for clinical trials.  

OpenAIRE

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and f...

Chan, Aw; Tetzlaff, Jm; Altman, Dg; Laupacis, A.; Gøtzsche, Pc; Krlez?a-jeric?, K.; Hro?bjartsson, A.; Mann, H.; Dickersin, K.; Berlin, Ja; Dore?, Cj; Parulekar, Wr; Summerskill, Ws; Groves, T.; Schulz, Kf

2013-01-01

211

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

212

Using regional broccoli trial data to select experimental hybrids for input into advanced yield trials  

Science.gov (United States)

A large amount of phenotypic trait data are being generated in regional trials that are implemented as part of the Specialty Crop Research Initiative (SCRI) project entitled “Establishing an Eastern Broccoli Industry”. These data are used to identify the best entries in the trials for inclusion in ...

213

Randomized discontinuation trials: utility and efficiency.  

Science.gov (United States)

The randomized discontinuation trial (RDT) is a two-phase trial. In phase I all patients are openly treated with the medication being evaluated. In phase II, those who have responded are randomly assigned to continue the same treatment or switch to placebo. Usually, non-compliers and "adverse reactors" identified in phase I are excluded from phase II. To investigate the value of this design, we reviewed the advantages and limitations of discontinuation studies, and compared the RDT design to the classic randomized clinical trial design in terms of clinical utility and efficiency (sample size). A computer model was used to study the efficiency of the two designs under a broad range of assumptions. The RDT design is particularly useful in studying the effect of long-term, non-curative therapies, especially when the clinically important effect is relatively small, and the use of placebo should be minimized for ethical or feasibility reasons. However, its use is limited if the objective of an investigation is to estimate the magnitude of absolute treatment effects and toxic effects in the source population, or to evaluate a potentially curative treatment. Our results indicate that selecting responders prior to randomization has a very strong effect on the relative efficiency of the trial. Further improvement may be achieved by excluding non-compliers and adverse reactors. Under the assumptions tested in our model, the sample size required in phase II of an RDT was only 20-50% of that in a classic trial. PMID:8263581

Kopec, J A; Abrahamowicz, M; Esdaile, J M

1993-09-01

214

Quality of clinical trials: A moving target.  

Science.gov (United States)

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

Bhatt, Arun

2011-10-01

215

Narrating the Mensalão trial: : configurations of corruption  

DEFF Research Database (Denmark)

Coming to a close in the last days of 2012, the trial of the so-called mensalão network was heralded as Brazil's trial of the century. Involving corruption in the top ranks of the business world and the former government, the process ended with an exceptional result in the sense that severe sentences were meted out to 25 of the 38 defendants, thereby breaking an established pattern of impunity for corrupt politicians in Brazilian courts. As a scandal potentially harmful for the governing party and the former president Luis “Lula” da Silva, the eyes and spotlights of the national media were fixed on the trial. However, the varying and contested ways in which the case was presented by media from the outbreak of the scandal in 2005 until the end of the trial bears witness to the fact that narratives concerning corruption scandals can potentially encompass a broad range of political and social actors besides those on trial. Viewing corruption as the thematic focus of the media texts, this wider scope of enquiry into the mensalão affair allows us to see that media, political actors and institutions use cases of corruption for much more than mere condemnation of transgressions: The narratives constructed in the Brazilian media reflect but also produce a series of salient political and social developments in the nation's self-imagination and political arena.

Damgaard, Mads

2015-01-01

216

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

217

SPIRIT 2013 Statement : Defining Standard Protocol Items for Clinical Trials  

DEFF Research Database (Denmark)

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

Chan, An-Wen; Tetzlaff, Jennifer M

2013-01-01

218

Investigator experiences with financial conflicts of interest in clinical trials  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Financial conflicts of interest (fCOI can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience. Methods Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source. Results 844 investigators responded (76% and 732 (66% provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively. Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%. Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43% and dissemination (53% to 64% stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85 or witnessed (n = 236 a fCOI; over 70% of these situations related to industry trials. Conclusion Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.

Van Laethem Marleen

2011-01-01

219

Developments in statistical evaluation of clinical trials  

CERN Document Server

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

Oud, Johan; Ghidey, Wendimagegn

2014-01-01

220

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. PMID:24804271

Xu, Linda W; Chow, Kevin K H; Lim, Michael; Li, Gordon

2014-01-01

221

Are outcome-adaptive allocation trials ethical?  

Science.gov (United States)

Randomization is firmly established as a cornerstone of clinical trial methodology. Yet, the ethics of randomization continues to generate controversy. The default, and most efficient, allocation scheme randomizes patients equally (1:1) across all arms of study. However, many randomized trials are using outcome-adaptive allocation schemes, which dynamically adjust the allocation ratio in favor of the better performing treatment arm. Advocates of outcome-adaptive allocation contend that it better accommodates clinical equipoise and promotes informed consent, since such trials limit patient-subject exposure to sub-optimal care. In this essay, we argue that this purported ethical advantage of outcome-adaptive allocation does not stand up to careful scrutiny in the setting of two-armed studies and/or early-phase research. PMID:25649106

Hey, Spencer Phillips; Kimmelman, Jonathan

2015-04-01

222

Trial in the Presence of the Accused  

OpenAIRE

The ICTY, the ICTR and the SCSL seem to have developed a rather common line. Though the ICTY RPE do not contain a provision similar to Rule 60 of the SCSL RPE (and Rule 82bis of the ICTR RPE), a revocation of the right to self-representation, in conformity with the Šešelj decision, would or could have the same effect as a trial in absentia: a trial without the participation of the defendant himself. Furthermore, repeated misconduct of the accused will result in his removal from ...

Franken, A. A.

2010-01-01

223

Crowd psychology in South African murder trials.  

Science.gov (United States)

South African courts have recently accepted social psychological phenomena as extenuating factors in murder trials. In one important case, eight railway workers were convicted of murdering four strike breakers during an industrial dispute. The court accepted conformity, obedience, group polarization, deindividuation, bystander apathy, and other well-established psychological phenomena as extenuating factors for four of the eight defendants, but sentenced the others to death. In a second trial, death sentences of five defendants for the "necklace" killing of a young woman were reduced to 20 months imprisonment in the light of similar social psychological evidence. Practical and ethical issues arising from expert psychological testimony are discussed. PMID:1746773

Colman, A M

1991-10-01

224

Blinding in randomized clinical trials: imposed impartiality  

DEFF Research Database (Denmark)

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

Hróbjartsson, A; Boutron, I

2011-01-01

225

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

226

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

227

Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background There is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest. UK Clinical Research Collaboration (UKCRC does not require a standard operating procedure (SOP for economic evaluation as a prerequisite for trial unit registration. We judge that such a SOP facilitates the integration of health economics into trials. Methods A collaboration between health economists and trialists at Bangor University led to the development of a SOP for economic evaluation alongside pragmatic trials, in addition to the twenty SOPs required by UKCRC for registration, which include randomisation, data management and statistical analysis. Results Our recent telephone survey suggests that no other UKCRC-registered trials unit currently has an economic SOP. Conclusion We argue that UKCRC should require, from all Trials Units undertaking economic evaluation and seeking registration or re-registration, a SOP for economic evaluation as one of their portfolio of supporting SOPs.

Russell Ian T

2008-11-01

228

Incidental genetic findings in randomized clinical trials: recommendations from the Genomics and Randomized Trials Network (GARNET).  

Science.gov (United States)

Recommendations and guidance on how to handle the return of genetic results to patients have offered limited insight into how to approach incidental genetic findings in the context of clinical trials. This paper provides the Genomics and Randomized Trials Network (GARNET) recommendations on incidental genetic findings in the context of clinical trials, and discusses the ethical and practical issues considered in formulating our recommendations. There are arguments in support of as well as against returning incidental genetic findings in clinical trials. For instance, reporting incidental findings in clinical trials may improve the investigator-participant relationship and the satisfaction of participation, but it may also blur the line between clinical care and research. The issues of whether and how to return incidental genetic findings, including the costs of doing so, should be considered when developing clinical trial protocols. Once decided, plans related to sharing individual results from the aim(s) of the trial, as well as incidental findings, should be discussed explicitly in the consent form. Institutional Review Boards (IRBs) and other study-specific governing bodies should be part of the decision as to if, when, and how to return incidental findings, including when plans in this regard are being reconsidered. PMID:23363732

Bookman, Ebony B; Din-Lovinescu, Corina; Worrall, Bradford B; Manolio, Teri A; Bennett, Siiri N; Laurie, Cathy; Mirel, Daniel B; Doheny, Kimberly F; Anderson, Garnet L; Wehr, Kate; Weinshilboum, Richard; Chen, Donna T

2013-01-01

229

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

Scientific Electronic Library Online (English)

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

Alberto, Grignolo.

230

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

231

Trial & Error to Collusion - The Discrete Case  

OpenAIRE

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

232

Assessing laboratory performance in Trichinella ring trials.  

Science.gov (United States)

Trichinosis (Trichinellosis) is a zoonotic disease acquired by eating raw or not adequately processed pork or wild game infected with the larvae of the roundworm genus Trichinella. According to European regulations, animals susceptible to Trichinella have to be examined for infestation. To evaluate the performance of laboratories in Germany, inter-laboratory comparisons known as "ring trials" were introduced by the Federal Institute for Risk Assessment in 2004. The current method of analysis makes use of tolerance zones based on the number of larvae in the sample, but does not permit one to determine if a given lab can detect an infested sample reliably, as required by the quality assurance recommendations of the International Commission on Trichinellosis (ICT). A new way of analysing the ring trial data is presented here, which is based on Bayesian hierarchical models. The model implements the ICT requirement by providing an estimate for the probability that a given lab would fail to detect a sample containing, say, five larvae. When applied to the 87 labs that participated in Germany's 2009 ring trials, it turns out this probability is greater than 10% for 21 of them, although only 10 of these in fact returned a false negative result. Such a new method is required to abide by the ICT requirements and make ring trials effective. PMID:24838905

Petroff, David; Hasenclever, Dirk; Makrutzki, Gregor; Riehn, Katharina; Lücker, Ernst

2014-08-01

233

History on Trial: The Case of Columbus.  

Science.gov (United States)

Describes the experiences of one high school class as they attempted to sort out the conflicting representations of Christopher Columbus. The students examined several textbooks and other histories. They then conducted a mock trial to determine if Columbus should be considered a criminal, a hero, or both. (MJP)

Como, Robert M.; O' Connor, John S.

1998-01-01

234

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

235

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.

Ye Chen-Izu

2002-01-01

236

Supportive and Palliative Care Clinical Trials  

Science.gov (United States)

Clinical trials for supportive and palliative care explore ways to improve the comfort and quality of life of cancer patients and cancer survivors, such as studying ways to help people prevent or manage nausea, pain, sleep disorders, depression, or other effects from cancer or its treatment.

237

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)

238

Assessing outcome in head injury trials.  

Science.gov (United States)

It is often suggested that one reason that neuroprotection trials in head injury have not shown benefit is the insensitivity of the outcome measures employed. The review considers strengths and weaknesses of the main approaches to assessing outcome in head injury trials. Determination of a response to neuroprotection requires a measure that is both sensitive to differences in outcome and is also influenced by brain injury. Sets of tests have been proposed for use in clinical trials that include scales of disability and handicap and measures of neuropsychological impairment. The Glasgow Outcome Scale (GOS) covers the whole spectrum of outcome after head injury and is the most popular primary endpoint for head injury trials. Although the GOS is a simple scale, small changes in the distribution of outcome can be detected with appropriate sample sizes. Late outcome in survivors can be influenced by various personal and environmental factors in addition to initial brain pathology. Other rating scales and questionnaires do not appear to offer significant advantages over the GOS, but can be used to supplement the information collected. Neuropsychological tests have properties that make them attractive as outcome measures, although there are practical difficulties with using tests. Neuropsychological assessment is potentially a powerful way of testing specific hypotheses concerning the effects of treatment. All current outcome measures have limitations; choice of the most appropriate endpoint will depend both on the properties of the measures available, and on the anticipated effects of treatment. PMID:11562298

Wilson, J T

2001-10-01

239

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.

240

Multiattribute evaluation of regional cotton variety trials.  

Science.gov (United States)

The Australian Cotton Cultivar Trials (ACCT) are designed to investigate various cotton [Gossypium hirsutum (L.)] lines in several locations in New South Wales and Queensland each year. If these lines are to be assessed by the simultaneous use of yield and lint quality data, then a multivariate technique applicable to three-way data is desirable. Two such techniques, the mixture maximum likelihood method of clustering and three-mode principal component analysis, are described and used to analyze these data. Applied together, the methods enhance each other's usefulness in interpreting the information on the line response patterns across the locations. The methods provide a good integration of the responses across environments of the entries for the different attributes in the trials. For instance, using yield as the sole criterion, the excellence of the namcala and coker group for quality is overlooked. The analyses point to a decision in favor of either high yields of moderate to good quality lint or moderate yield but superior lint quality. The decisions indicated by the methods confirmed the selections made by the plant breeders. The procedures provide a less subjective, relatively easy to apply and interpret analytical method of describing the patterns of performance and associations in complex multiattribute and multilocation trials. This should lead to more efficient selection among lines in such trials. PMID:24226223

Basford, K E; Kroonenberg, P M; Delacy, I H; Lawrence, P K

1990-02-01

241

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)

242

Clinical Trials: A Crucial Key to Human Health Research  

Science.gov (United States)

... Past Issues Clinical Trials: A Crucial Key to Human Health Research Past Issues / Summer 2006 Table of Contents ... Javascript on. Photo: PhotoDisc At the forefront of human health research today are clinical trials—studies that use ...

243

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

Science.gov (United States)

... about external links Menu Questions and Answers: NIH Glucosamine/Chondroitin Arthritis Intervention Trial Primary Study On this ... More Information About the Study What is the Glucosamine/chondroitin Arthritis Intervention Trial (GAIT)? GAIT is the ...

244

Use of crowdsourcing for cancer clinical trial development.  

Science.gov (United States)

Patient and physician awareness and acceptance of trials and patient ineligibility are major cancer clinical trial accrual barriers. Yet, trials are typically conceived and designed by small teams of researchers with limited patient input. We hypothesized that through crowdsourcing, the intellectual and creative capacity of a large number of researchers, clinicians, and patients could be harnessed to improve the clinical trial design process. In this study, we evaluated the feasibility and utility of using an internet-based crowdsourcing platform to inform the design of a clinical trial exploring an antidiabetic drug, metformin, in prostate cancer. Over a six-week period, crowd-sourced input was collected from 60 physicians/researchers and 42 patients/advocates leading to several major (eg, eligibility) and minor modifications to the clinical trial protocol as originally designed. Crowdsourcing clinical trial design is feasible, adds value to the protocol development process, and may ultimately improve the efficiency of trial conduct. PMID:25217580

Leiter, Amanda; Sablinski, Tomasz; Diefenbach, Michael; Foster, Marc; Greenberg, Alex; Holland, John; Oh, William K; Galsky, Matthew D

2014-10-01

245

Most Breast Cancer Screening Trials Have a Flawed Design  

OpenAIRE

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

246

Step 4: Closing Out a Cancer Prevention Clinical Trial  

Science.gov (United States)

Step 4: 2003 Closing Out a Cancer Prevention Clinical Trial Standard Operating Procedures The standard operating procedures (SOPs) listed below are written to help study staff close-out a Cancer Prevention Clinical Trial. SOP #1: Conducting Close-out

247

Beyond randomized controlled trials: a critical comparison of trials with nonrandomized studies.  

Science.gov (United States)

Observational analogs of randomized clinical trials (RCTs) are well accepted in the study of disease risk factors, diagnosis, and prognosis. There is controversy about observational studies when the focus is on the intended benefit due to lack of blinding and poor control for unmeasured confounding. Well-designed randomized clinical trials are costly both in time and money. Therefore, existing databases are used increasingly and are often the only feasible source with which to examine delayed health effects. We reviewed the reasons for possible discrepancies between RCTs and observational studies. There can be different patient populations, differences in therapeutic regimen, control of confounding, follow-up, measuring outcome, and differences arising from the intention-to-treat analysis. Observational studies cannot replace trials, nor do trials make observational studies unnecessary. Both designs are susceptible to particular bias, so neither provides perfect information. PMID:17058242

Sørensen, Henrik Toft; Lash, Timothy L; Rothman, Kenneth J

2006-11-01

248

Early participant attrition from clinical trials: role of trial design and logistics. | accrualnet.cancer.gov  

Science.gov (United States)

Researchers determined that to help reduce attrition in early phases of a trial, the time between consent to be screened and screening should be minimized. Additionally, duration of screening, especially for minority patients, should be minimized.

249

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

Science.gov (United States)

Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection. PMID:24440100

Logvinov, Ilana

2014-03-01

250

Establishing a clinical trials network in nephrology: experience of the Australasian Kidney Trials Network.  

Science.gov (United States)

Chronic kidney disease is a major public health problem globally. Despite this, there are fewer high-quality, high-impact clinical trials in nephrology than other internal medicine specialties, which has led to large gaps in evidence. To address this deficiency, the Australasian Kidney Trials Network, a Collaborative Research Group, was formed in 2005. Since then, the Network has provided infrastructure and expertise to conduct patient-focused high-quality, investigator-initiated clinical trials in nephrology. The Network has not only been successful in engaging the nephrology community in Australia and New Zealand but also in forming collaborations with leading researchers from other countries. This article describes the establishment, development, and functions of the Network. The article also discusses the current and future funding strategies to ensure uninterrupted conduct of much needed clinical trials in nephrology to improve the outcomes of patients affected by kidney diseases with cost-effective interventions. PMID:24088955

Morrish, Alicia T; Hawley, Carmel M; Johnson, David W; Badve, Sunil V; Perkovic, Vlado; Reidlinger, Donna M; Cass, Alan

2014-01-01

251

Alternative medicine on trial: Clinical trials home in on complementary therapies and complex natural products  

OpenAIRE

Scientists are increasingly applying the rigours of clinical trials to test the efficacy of alternative therapies and natural compounds. The results so far give a mixed picture whether the therapies tested fare better than classical drugs or even placebo.

Hunter, Philip

2012-01-01

252

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

Directory of Open Access Journals (Sweden)

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

Grimshaw Jeremy M

2006-03-01

253

Novel ocular antihypertensive compounds in clinical trials  

Directory of Open Access Journals (Sweden)

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

Chen J

2011-05-01

254

Use of ordinal outcomes in vascular prevention trials: comparison with binary outcomes in published trials  

OpenAIRE

Background and Purpose—Vascular prevention trials mostly count “yes/no” (binary) outcome events, eg, stroke/no stroke. Analysis of ordered categorical vascular events (eg, fatal stroke/nonfatal stroke/no stroke) is clinically relevant and could be more powerful statistically. Although this is not a novel idea in the statistical community, ordinal outcomes have not been applied to stroke prevention trials in the past. Methods—Summary data on stroke, myocardial infarction, c...

Bath, Philip M. W.; Geeganage, Chamila; Gray, Laura J.; Collier, T.; Pocock, S.

2008-01-01

255

Establishing a clinical trials network in nephrology: experience of the Australasian Kidney Trials Network  

OpenAIRE

Chronic kidney disease is a major public health problem globally. Despite this, there are fewer high-quality, high-impact clinical trials in nephrology than other internal medicine specialties, which has led to large gaps in evidence. To address this deficiency, the Australasian Kidney Trials Network, a Collaborative Research Group, was formed in 2005. Since then, the Network has provided infrastructure and expertise to conduct patient-focused high-quality, investigator-initiated clinical tri...

Morrish, Alicia T.; Hawley, Carmel M.; Johnson, David W.; Badve, Sunil V.; Perkovic, Vlado; Reidlinger, Donna M.; Cass, Alan

2013-01-01

256

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

OpenAIRE

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

Lamb, Se; Williams, Ma; Williamson, Em; Gates, S.; Withers, Ej; Mt-isa, S.; Ashby, D.; Castelnuovo, E.; Underwood, M.; Cooke, Mw

2012-01-01

257

ICD-10 FIELD TRIALS IN INDIA - A REPORT  

OpenAIRE

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.

Raghuram, R.; Shamasundar, C.

1992-01-01

258

Analysis of repeated measurement data in the clinical trials  

OpenAIRE

Statistics is an integral part of Clinical Trials. Elements of statistics span Clinical Trial design, data monitoring, analyses and reporting. A solid understanding of statistical concepts by clinicians improves the comprehension and the resulting quality of Clinical Trials. In biomedical research it has been seen that researcher frequently use t-test and ANOVA to compare means between the groups of interest irrespective of the nature of the data. In Clinical Trials we record the data on the ...

Singh, Vineeta; Rana, Rakesh Kumar; Singhal, Richa

2013-01-01

259

Cluster randomised trials in the medical literature: two bibliometric surveys  

OpenAIRE

Abstract Background Several reviews of published cluster randomised trials have reported that about half did not take clustering into account in the analysis, which was thus incorrect and potentially misleading. In this paper I ask whether cluster randomised trials are increasing in both number and quality of reporting. Methods Computer search for papers on cluster randomised trials since 1980, hand search of trial reports published in selected volumes of the British Medical Journal over 20 y...

Martin, Bland J.

2004-01-01

260

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

261

A National Strategy to Develop Pragmatic Clinical Trials Infrastructure  

OpenAIRE

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

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

2014-01-01

262

Behavioral risk assessment in HIV Vaccine Trials Network (HVTN) clinical trials: A qualitative study exploring HVTN staff perspectives  

OpenAIRE

In HIV vaccine trials, the collection and analysis of participant behavior data associated with risk of acquiring HIV-infection is important for a number of reasons. Although the rationale for behavioral risk assessment in HIV vaccine clinical trials is clear, consistent collection of behavioral data over time and across protocols has been challenging for the HIV Vaccine Trials Network (HVTN). Integrating biomedical and behavioral research within the same preventive vaccine clinical trial has...

Andrasik, Michele Peake; Karuna, Shelly T.; Nebergall, Michelle; Koblin, Beryl A.; Kublin, Jim G.

2013-01-01

263

Randomization in substance abuse clinical trials  

Directory of Open Access Journals (Sweden)

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

Woolson Robert F

2006-02-01

264

Management of clinical trials in developing countries.  

Science.gov (United States)

Clinical trials need to consider specifics in trial circumstances when novel measures to improve health call for assessment in developing countries. Predictions regarding safety and efficacy under regional conditions, deriving from data of trials in affected populations in another part of the world, cannot always be accepted as reliable indicators of future regional performance. The primary objective should be to reveal new information. This discussion of the management of clinical trials in developing countries focuses on the following: the protocol; staff and supervision; locations and logistics; the use of a pilot study; drugs and compliance; and ethics. At an initial workshop a planning group with the broadest possible representation draws up a protocol. Ideally, the protocol is never imposed but is developed through extensive consultation and coordination. Its initial objective is an agreement on how to make a specific study feasible. Initial goals should be restricted to answering a few simple but meaningful questions. Information in the study protocol includes: aims and objectives; precise definitions of clinical variables; detailed description plus frequency and timing of clinical procedures, laboratory tests, and so forth; case report forms; consent forms and any warning notices written in the local language; work manuals for the pharmacist of drug supervisor; the treatment allocation procedure and individual treatment charts; the labeling code, emergency code breaking, and referral procedures; precise guidelines for evaluation and management of known adverse reactions; and an investigational data brochure. Selection of a competent, dependable, and enthusiastic principal investigator, available for the full duration of the study is essential. Suitable trial sites should be carefully chosen to avoid conditions that might prevent application of adequate scientific standards. In case of doubt about the logistical feasibility, starting with a trial run of the test procedures or with a pilot study using an established drug should be considered in order to detect potential problems concerning availability of scientific and technical expertise, equipment or reagents. It is necessary to check national clearances for investigating new agents. Permits may be required from a review body, a manufacturer, or from an authority. All needed drug supplies should be obtained at once together with information on stability under expected storage conditions. An independent measure of patient compliance needs to be agreed upon. Projects should be reviewed as well as approved by an independent local group, practicing the highest standards of protection of the rights of the individual. Data collection begins with identification of subjects, by photographs of faces, in addition to careful records of name, household, domicile, and occupation. PMID:6832461

de Maar, E W; Chaudhury, R R; Kofi Ekue, J M; Granata, F; Walker, A N

1983-01-01

265

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 nourishedwas 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.)

266

Are randomized clinical trials good for us (in the short term)? Evidence for a "trial effect". | accrualnet.cancer.gov  

Science.gov (United States)

The authors of this literature review found weak evidence that randomized clinical trials have a positive effect on patient outcomes. This effect seems to be larger when an existing effective treatment is used as part of the trial’s protocol.

267

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

Science.gov (United States)

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

268

Extending the CONSORT statement to cluster randomized trials: for discussion.  

Science.gov (United States)

The need for clear reporting of randomized controlled trials has been emphasized recently. The CONSORT Statement has made evidence-based suggestions for a checklist and a patient flow diagram. Adapting this for cluster randomized controlled trials presents particular challenges. Simple changes in the checklist and diagram for the completely randomized two level cluster randomized trials are suggested for discussion. An example taken from an unpublished trial demonstrates that these changes are less simple to implement, although extensions to electronic publications may be helpful. These suggestions should be formally evaluated. Further work is required to consider the cases of more levels and of stratified or pair-matched cluster randomized trials. PMID:11180315

Elbourne, D R; Campbell, M K

2001-02-15

269

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

270

Life insurance and clinical trial participants.  

Science.gov (United States)

Are the informed consent forms of clinical trials silent on the rights and obligations of participants with respect to their life insurance policies? Though life insurance in India has poor penetration, it has increased over the last couple of years after the entry of private insurance providers. When a person buys his life insurance, the insurance company carries out the process of underwriting which involves the risk profile assessment of the individual on the basis of information provided, including reports of medical investigations (if done). The policy documents of the majority of insurance providers state that a claim is not allowed in a case of suicide within one year of commencement, or revival, of the policy. In a parallel situation, assume that a person enters a drug trial leading to change in the risk profile. PMID:25716445

Shah, Pankaj

2015-01-01

271

Randomised controlled trials: important but overrated?  

LENUS (Irish Health Repository)

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

Boylan, J F

2012-02-01

272

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.)

273

Clinical trials of conformal therapy - physics aspects  

International Nuclear Information System (INIS)

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

274

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

275

Is the haematopoietic effect of testosterone mediated by erythropoietin? The results of a clinical trial in older men.  

Science.gov (United States)

The stimulatory effects of testosterone on erythropoiesis are very well known, but the mechanisms underlying the erythropoietic action of testosterone are still poorly understood, although erythropoietin has long been considered a potential mediator. A total of 108 healthy men >65 years old with serum testosterone concentration dL were recruited by direct mailings to alumni of the University of Pennsylvania and Temple University, and randomized to receive a 60-cm(2) testosterone or placebo patch for 36 months. Ninety-six subjects completed the trial. We used information and stored serum specimens from this trial to test the hypothesis that increasing testosterone increases haemoglobin by stimulating erythropoietin production. We used information of 67 men, 43 in the testosterone group and 24 in the placebo group who had banked specimens available for assays of testosterone, haemoglobin and erythropoietin at baseline and after 36 months. The original randomized clinical study was primarily designed to verify the effects of testosterone on bone mineral density. The primary outcome of this report was to investigate whether or not transdermal testosterone increases haemoglobin by increasing erythropoietin levels. The mean age ± SD of the 67 subjects at baseline was 71.8 ± 4.9 years. Testosterone replacement therapy for 36 months, as compared with placebo, induced a significant increase in haemoglobin (0.86 ± 0.31 g/dL, p = 0.01), but no change in erythropoietin levels (-0.24 ± 2.16 mIU/mL, p = 0.91). Included time-varying measure of erythropoietin did not significantly account for the effect of testosterone on haemoglobin (Treatment-by-time: ? = 0.93, SE = 0.33, p = 0.01). No serious adverse effect was observed. Transdermal testosterone treatment of older men for 36 months significantly increased haemoglobin, but not erythropoietin levels. The haematopoietic effect of testosterone does not appear to be mediated by stimulation of erythropoietin production. PMID:23258626

Maggio, M; Snyder, P J; Ceda, G P; Milaneschi, Y; Luci, M; Cattabiani, C; Masoni, S; Vignali, A; Volpi, R; Lauretani, F; Peachey, H; Valenti, G; Cappola, A R; Longo, D; Ferrucci, L

2013-01-01

276

Application of trial risk acceptance criteria  

International Nuclear Information System (INIS)

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

277

Clinical trial of a weaning protocol  

OpenAIRE

Krishnan and colleagues have conducted a prospective clinical trial of a weaning strategy previously demonstrated to enhance clinical outcomes of mechanically ventilated patients. They draw conclusions quite different from those drawn in an accompanying editorial. Krishnan and colleagues compared the outcomes of patients supported with mechanical ventilation for at least 24 hours. The outcome of those patients weaned from mechanical ventilation was compared with the outcome of those patients ...

Morris, Alan H.

2004-01-01

278

Northwestern University trial emerging optical solutions  

CERN Multimedia

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

2001-01-01

279

Randomised clinical trial of chest drainage systems.  

OpenAIRE

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

280

Analyzing Incomplete Discrete Longitudinal Clinical Trial Data  

OpenAIRE

Commonly used methods to analyze incomplete longitudinal clinical trial data include complete case analysis (CC) and last observation carried forward (LOCF). However, such methods rest on strong assumptions, including missing completely at random (MCAR) for CC and unchanging profile after dropout for LOCF. Such assumptions are too strong to generally hold. Over the last decades, a number of full longitudinal data analysis methods have become available, such as the linear mix...

Jansen, Ivy; Beunckens, Caroline; Molenberghs, Geert; Verbeke, Geert; Mallinckrodt, Craig

2006-01-01

281

Addressing Missing Data in Clinical Trials  

OpenAIRE

The reliability and interpretability of results from clinical trials can be substantially reduced by missing data. Frequently used approaches to address these concerns, such as upward adjustments in sample sizes or simplistic methods for handling missing data, including last-observation-carried-forward, complete-case, or worst-case analyses, are usually inadequate. Although rational imputation methods may be useful to treat missingness after it has occurred, these methods depend on untestable...

Fleming, Thomas R.

2011-01-01

282

Ethics of clinical trials in Nigeria  

OpenAIRE

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

Okonta, Patrick I.

2014-01-01

283

A Matched Crossover Design for Clinical Trials  

OpenAIRE

Two design principles are used frequently in clinical trials: 1) A subject is "matched" or "paired" with a similar subject to reduce the chance that other variables obscure the primary comparison of interest. 2) A subject serves as his/her own control by "crossing over" from one treatment to another during the course of an experiment. There are situations in which it may be advantageous to use the two design principles –crossing over and matching –simultaneously. That is, it may be advant...

Simon, Laura J.; Chinchilli, Vernon M.

2007-01-01

284

Continuous Glucose Monitoring and Clinical Trials  

OpenAIRE

The use of glucose sensors during clinical trials seems like a great idea at first glance. Continuous glucose monitoring (CGM) should allow the gathering of more detailed information about metabolic control, without requiring much additional effort. In principle, CGM can reduce the duration of such studies and the number of participants required. The aim of this commentary is to highlight some of the reasons why, in practice, at least some of these hopes have not been realized. It is not only...

Heinemann, Lutz

2009-01-01

285

Multiple treatment comparisons in epilepsy monotherapy trials  

Directory of Open Access Journals (Sweden)

Full Text Available 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 antiepileptic drugs given as monotherapy. Methods Multiple treatment comparisons from epilepsy monotherapy trials were synthesized in a single stratified Cox regression model adjusted for treatment by epilepsy type interactions and making use of direct and indirect evidence. Primary outcomes were time to treatment failure and time to 12 month remission from seizures. A secondary outcome was time to first seizure. Results Individual patient data for 6418 patients from 20 randomised trials comparing eight antiepileptic drugs were synthesized. For partial onset seizures (4628 (72% patients, lamotrigine, carbamazepine and oxcarbazepine provide the best combination of seizure control and treatment failure. Lamotrigine is clinically superior to all other drugs for treatment failure but estimates suggest a disadvantage compared to carbamazepine for time to 12 month remission [Hazard Ratio (95% Confidence Interval = 0.87(0.73 to 1.04] and time to first seizure [1.29(1.13 to 1.48]. Phenobarbitone may delay time to first seizure [0.77(0.61 to 0.96] but at the expense of increased treatment failure [1.60(1.22 to 2.10]. For generalized onset tonic clonic seizures (1790 (28% patients estimates suggest valproate or phenytoin may provide the best combination of seizure control and treatment failure but some uncertainty remains about the relative effectiveness of other drugs. Conclusion For patients with partial onset seizures, results favour carbamazepine, oxcarbazepine and lamotrigine. For generalized onset tonic clonic seizures, results favour valproate and phenytoin.

Chadwick David W

2007-11-01

286

Reinforcement learning design for cancer clinical trials  

OpenAIRE

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

287

Gender analysis of moxifloxacin clinical trials  

OpenAIRE

Purpose: To determine the inclusion of women and the sex-stratification of results in moxifloxacin Clinical Trials (CTs), and to establish whether these CTs considered issues that specifically affect women, such as pregnancy and use of hormonal therapies. Previous publications about women’s inclusion in CTs have not specifically studied therapeutic drugs. Although this type of drug is taken by men and women at a similar rate, adverse effects occur more frequently in the latter. Methods: We ...

Chilet-rosell, Elisa; Ruiz-cantero, Ma Teresa; Pardo, Ma Angeles

2013-01-01

288

Incidental diagnosis in healthy clinical trial subjects.  

OpenAIRE

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, Cj; Rowland, R.; Lillie, Pj; Meyer, J.; Sheehy, Sh; O Hara, Ga; Hamill, M.; Donaldson, H.; Dinsmore, L.; Poulton, Id; Gilbert, Sc; Mcshane, H.; Hill, Av

2012-01-01

289

Randomized controlled trials in bariatric surgery.  

Science.gov (United States)

To fill a void in the literature, we performed a literature search and subsequently reviewed randomized controlled trials (RCTs) in the field of obesity surgery that were published over the past 40 years. All RCTs published in the English between January 1972 and December 2011 were identified through a literature search using the PubMed database. The following search terms were used: "bariatric surgery", "obesity surgery", and "weight reducing surgery". Studies of basic science and anesthesia-related pain management were excluded. The extracted trials were divided into four groups: comparisons of different interventions, intraoperative surgical techniques, preoperative evaluation, and postoperative care. The literature search produced 753 manuscripts, of which 168 met the eligibility criteria. Among 168 papers, 32 % compared different interventions, 48 % assessed intraoperative surgical techniques, 18 % assessed postoperative care, and the remaining 2 % assessed preoperative evaluation. The RCTs were published in 47 different journals, most commonly in Obesity Surgery (28.6 %) and the Annals of Surgery (11.9 %). Trials were conducted in 25 different countries, with the greatest contribution from the USA (35.1 %). There was a progressive increase in published trials from 1972 to 2011, with 119 RCTs (70.8 %) being published over the last decade. A trend for an increasing number of published RCTs in the field of bariatric surgery was observed over the recent years. Although data from large, adequately powered, long-term RCTs are still lacking, any surgical intervention appears to be more effective than medical care for the treatment of morbid obesity. PMID:23099855

Chan, Chien-Pin; Wang, Bing-Yen; Cheng, Ching-Yuan; Lin, Ching-Hsiung; Hsieh, Ming-Chia; Tsou, Jun-Jiun; Lee, Wei-Jei

2013-01-01

290

Decision-Making Trial and Evaluation Laboratory  

OpenAIRE

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

Elham Falatoonitoosi; Zulkiflle Leman; Shahryar Sorooshian; Meysam Salimi

2013-01-01

291

A multivariate approach linking reported side effects of clinical antidepressant and antipsychotic trials to in vitro binding affinities.  

Science.gov (United States)

The vast majority of approved antidepressants and antipsychotics exhibit a complex pharmacology. The mechanistic understanding of how these psychotropic medications are related to adverse drug reactions (ADRs) is crucial for the development of novel drug candidates and patient adherence. This study aims to associate in vitro assessed binding affinity profiles (39 compounds, 24 molecular drug targets) and ADRs (n=22) reported in clinical trials of antidepressants and antipsychotics (n>59.000 patients) by the use of robust multivariate statistics. Orthogonal projection to latent structures (O-PLS) regression models with reasonable predictability were found for several frequent ADRs such as nausea, diarrhea, hypotension, dizziness, headache, insomnia, sedation, sleepiness, increased sweating, and weight gain. Results of the present study support many well-known pharmacological principles such as the association of hypotension and dizziness with ?1-receptor or sedation with H1-receptor antagonism. Moreover, the analyses revealed novel or hardly investigated mechanisms for common ADRs including the potential involvement of 5-HT6-antagonism in weight gain, muscarinic receptor antagonism in dizziness, or 5-HT7-antagonism in sedation. To summarize, the presented study underlines the feasibility and value of a multivariate data mining approach in psychopharmacological development of antidepressants and antipsychotics. PMID:25044049

Michl, Johanna; Scharinger, Christian; Zauner, Miriam; Kasper, Siegfried; Freissmuth, Michael; Sitte, Harald H; Ecker, Gerhard F; Pezawas, Lukas

2014-09-01

292

Money and morals : ending clinical trials for financial reasons.  

Science.gov (United States)

Too often, biopharmaceutical companies stop their clinical trialsClinical trials solely for financial reasons. In this chapter, we discuss this phenomenon against the backdrop of a 2011 decision by Geron Corporation to abandon its stem cell clinical trial for spinal cord injury (SCI), the preliminary results of which were released in May 2014. We argue that the resultant harms are widespread and are different in nature from the consequences of stopping trials for scientific or medical reasons. We examine the ethical and social effects that arise from such decisions and discuss them in light of ethical frameworks, including duties of individual stakeholders and corporate sponsors. We offer ways that sponsors and clinical sites can ensure that trials are responsibly started, and once started adequately protect the interests of participants. We conclude with recommendations that industry sponsors of clinical trialsClinical trials should adopt in order to advance a collective and patient-centered research ethic. PMID:25062706

Eaton, Margaret L; Kwon, Brian K; Scott, Christopher Thomas

2015-01-01

293

Clinical Trials and Treatment of ATL.  

Science.gov (United States)

ATL is a distinct peripheral T-lymphocytic malignancy associated with human T-cell lymphotropic virus type I (HTLV-1). The diversity in clinical features and prognosis of patients with this disease has led to its subtype-classification into four categories, acute, lymphoma, chronic, and smoldering types, defined by organ involvement, and LDH and calcium values. In case of acute, lymphoma, or unfavorable chronic subtypes (aggressive ATL), intensive chemotherapy like the LSG15 regimen (VCAP-AMP-VECP) is usually recommended if outside of clinical trials, based on the results of a phase 3 trial. In case of favorable chronic or smoldering ATL (indolent ATL), watchful waiting until disease progression has been recommended, although the long-term prognosis was inferior to those of, for instance, chronic lymphoid leukemia. Retrospective analysis suggested that the combination of interferon alpha and zidovudine was apparently promising for the treatment of ATL, especially for types with leukemic manifestation. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is also promising for the treatment of aggressive ATL possibly reflecting graft versus ATL effect. Several new agent trials for ATL are ongoing and in preparation, including a defucosylated humanized anti-CC chemokine receptor 4 monoclonal antibody, IL2-fused with diphtheria toxin, histone deacetylase inhibitors, a purine nucleoside phosphorylase inhibitor, a proteasome inhibitor, and lenalidomide. PMID:23259064

Tsukasaki, Kunihiro; Tobinai, Kensei

2012-01-01

294

Gateways to clinical trials. December 2008.  

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 have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: AAV1/SERCA2a; Abatacept, ABT-263, Adalimumab, Aflibercept, Afobazole, Aliskiren fumarate, Anakinra, Atazanavir/ritonavir, Aviscumine, Axitinib, Azacitidine; Bevacizumab, Biphasic insulin aspart, Bortezomib, Briobacept; Carmoterol hydrochloride, CCX-282, Ceftobiprole medocaril, Certolizumab pegol, Cetuximab; Darifenacin hydrobromide, Dasatinib, Denosumab, Doripenem, Duloxetine hydrochloride; E-7080, Epratuzumab, Erlotinib hydrochloride, Everolimus, Exenatide, Ezetimibe/simvastatin; Gefitinib, Golimumab; gamma-Hydroxybutyrate sodium; Imatinib mesylate, Insulin detemir, Insulin glulisine, IVX-0142; Laquinimod sodium, Linezolid, Lopinavir/ritonavir; Ocrelizumab, Omalizumab; Parecoxib sodium, Pemetrexed disodium, Pregabalin; Rosuvastatin calcium, Rotigotine; Sorafenib, Sugammadex sodium; Tapentadol hydrochloride, Tenofovir disoproxil fumarate/emtricitabine, Tocilizumab; Ularitide, Ustekinumab; Valsartan/amlodipine besylate, Varenicline tartrate, Vatalanib succinate, Vildagliptin, Vorinostat. PMID:19271026

Tomillero, A; Moral, M A

2008-12-01

295

Sample size for equivalence trials: a case study from a vaccine lot consistency trial.  

Science.gov (United States)

For some trials, simple but subtle assumptions can have a profound impact on the size of the trial. A case in point is a vaccine lot consistency (or equivalence) trial. Standard sample size formulas used for designing lot consistency trials rely on only one component of variation, namely, the variation in antibody titers within lots. The other component, the variation in the means of titers between lots, is assumed to be equal to zero. In reality, some amount of variation between lots, however small, will be present even under the best manufacturing practices. Using data from a published lot consistency trial, we demonstrate that when the between-lot variation is only 0.5 per cent of the total variation, the increase in the sample size is nearly 300 per cent when compared with the size assuming that the lots are identical. The increase in the sample size is so pronounced that in order to maintain power one is led to consider a less stringent criterion for demonstration of lot consistency. The appropriate sample size formula that is a function of both components of variation is provided. We also discuss the increase in the sample size due to correlated comparisons arising from three pairs of lots as a function of the between-lot variance. PMID:18416439

Ganju, Jitendra; Izu, Allen; Anemona, Alessandra

2008-08-30

296

International subarachnoid aneurysm trial – ISAT Part II: Study protocol for a randomized controlled trial  

Science.gov (United States)

Background The International Subarachnoid Aneurysm Trial (ISAT) demonstrated improved one-year clinical outcomes for patients with ruptured intracranial aneurysms treated with endovascular coiling compared to surgical clipping. Patients included in ISAT were mostly good grade subarachnoid hemorrhage (SAH) patients with small anterior circulation aneurysms. The purported superiority of coiling is commonly extrapolated to patients not studied in the original trial or to those treated using new devices not available at the time. Conversely, many patients are treated by clipping despite ISAT, because they are thought either to be better candidates for surgery, or to offer more durable protection from aneurysm recurrences. These practices have never been formally validated. Thus, for many ruptured aneurysm patients the question of which treatment modality leads to a superior clinical outcome remains unclear. Methods/trial design ISAT II is a pragmatic, multicenter, randomized trial comparing clinical outcomes for non-ISAT patients with subarachnoid hemorrhage allocated to coiling or clipping. Inclusion criteria are broad. The primary end-point is the incidence of poor clinical outcome (defined as mRS >2) at one year, just as in ISAT. Secondary end-points include measures of treatment safety for a number of pre-specified subgroups, with efficacy end-points including the presence of a major recurrence at one year; 1,896 patients (862 each arm plus 10% losses) are required to demonstrate a significant difference between coiling and clipping, hypothesizing 23% and 30% poor clinical outcome rates, for coiling and clipping, respectively. The trial should involve at least 50 international centers, and will take approximately 12 years to complete. Analysis will be by intention-to-treat. Trial registration ISAT II is registered at clinicaltrials.gov: NCT01668563. PMID:23714335

2013-01-01

297

Phase I trials involving radiation therapy, quantifying the risks  

International Nuclear Information System (INIS)

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

298

Clinical trials in crisis: Four simple methodologic fixes.  

Science.gov (United States)

There is growing consensus that the US clinical trials system is broken, with trial costs and complexity increasing exponentially, and many trials failing to accrue. Yet, concerns about the expense and failure rate of randomized trials are only the tip of the iceberg; perhaps what should worry us most is the number of trials that are not even considered because of projected costs and poor accrual. Several initiatives, including the Clinical Trials Transformation Initiative and the "Sensible Guidelines Group" seek to push back against current trends in clinical trials, arguing that all aspects of trials-including design, approval, conduct, monitoring, analysis, and dissemination-should be based on evidence rather than contemporary norms. Proposed here are four methodologic fixes for current clinical trials. The first two aim to simplify trials, reducing costs, and increasing patient acceptability by dramatically reducing eligibility criteria-often to the single criterion that the consenting physician is uncertain which of the two randomized arms is optimal-and by clinical integration, investment in data infrastructure to bring routinely collected data up to research grade to be used as endpoints in trials. The second two methodologic fixes aim to shed barriers to accrual, either by cluster randomization of clinicians (in the case of modifications to existing treatment) or by early consent, where patients are offered the chance of being randomly selected to be offered a novel intervention if disease progresses at a subsequent point. Such solutions may be partial, or result in a new set of problems of their own. Yet, the current crisis in clinical trials mandates innovative approaches: randomized trials have resulted in enormous benefits for patients, and we need to ensure that they continue to do so. PMID:25278228

Vickers, Andrew J

2014-12-01

299

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

OpenAIRE

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 samp...

Shepperd Sasha; Glasziou Paul P; Brassey Jon

2010-01-01

300

SELECT Trial Results Examined: Why Fish Oil, DHA and “Oily Fish” Are Inflammatory, Leading to Increases in Prostate Cancer, Epithelial Cancers and CVD  

Directory of Open Access Journals (Sweden)

Full Text Available In July 2013, using data and plasma collected in the Selenium and Vitamin E Cancer Prevention Trial (SELECT, results were shown consistent with prior results of the controversial 2011 Prostate Cancer Prevention Trial. Both trials exhibited unexpected associations: 1 Fish oil and fish oil’s DHA significantly increase prostate cancer in men; in particular, high grade prostate cancer; 2 Harmful trans fats did not exhibit their well-known significant and harmful effects; 3 Omega-6 series fatty acids LA (Parent omega-6 and long-chain metabolite AA were not shown to increase risk of prostate cancer as expected. These unexpected results mystified researchers. However, these clinical results confirm the prevailing medical science; they do not run counter to it. Pre-21st century studies mistook irrelevant associations for cause/effect relationships, disregarding known incontrovertible science. Utilizing established state-of-the-art physiology and biochemistry, these mistakes will be fully explained. When taken prophylactically in the amounts normally recommended, marine (fish oils will be shown harmful to humans. Marine oil—and, in particular, its component DHA, with its highly reactive 5 bis-allylic bonds—will be shown to be highly inflammatory, therefore cancer-causing. These epidemiological studies are complemented by a variety of underpublicized physiological and biochemical findings showing that fish oil heightens premature lipid peroxidation and damages arterial endothelium in a way that increases the risk of all cancers. Most importantly, the cancer-causing effect of fish oil supplements, and all marine oils, will physiologically and biochemically be shown to possibly be significantly more harmful than trans fats.

Brian Scott Peskin

2013-10-01

301

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

302

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)

303

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)

304

Dynamic flux synthesis with discontinuous trial functions  

International Nuclear Information System (INIS)

A method has been developed that allows the use of precalculated dynamic flux shapes as trial functions for the solution of the space-dependent kinetics equation. The basis of the method is that, for the type of transients encountered in CANDU design and safety analysis, the delayed neutron source that arises from precursors that are formed during the transient has a negligible effect on the shaping of the dynamic flux. This allows a single set of available flux shapes to be used in solving a wide variety of problems. The accuracy of the method is demonstrated by a comparison with finite difference solutions

305

InovCity – structure of trials evaluation  

OpenAIRE

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

Moreira, Ine?s Almeida Campos

2012-01-01

306

Optimal sampling ratios in comparative diagnostic trials.  

Science.gov (United States)

A subjective sampling ratio between the case and the control groups is not always an efficient choice to maximize the power or to minimize the total required sample size in comparative diagnostic trials.We derive explicit expressions for an optimal sampling ratio based on a common variance structure shared by several existing summary statistics of the receiver operating characteristic curve. We propose a two-stage procedure to estimate adaptively the optimal ratio without pilot data. We investigate the properties of the proposed method through theoretical proofs, extensive simulation studies and a real example in cancer diagnostic studies. PMID:24948841

Dong, Ting; Tang, Liansheng Larry; Rosenberger, William F

2014-04-01

307

Good clinical practice: International quality standard for clinical trials  

Directory of Open Access Journals (Sweden)

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

Radulovi? Siniša S.

2003-01-01

308

The Sri Lanka Clinical Trials Registry--moving forward.  

Science.gov (United States)

The Sri Lanka Clinical Trials Registry (SLCTR) is a Primary Registry in the Registry Network of the World Health Organization's International Clinical Trials Registry Platform (WHO-ICTRP), and regularly feeds data to its Clinical Trials Search Portal. Over the last few years, the SLCTR has been able to achieve its original objective of providing a national trial register for Sri Lankan researchers, but its role has always been more than that of a mere storehouse of trial data. The research landscape is rapidly changing in Sri Lanka, and the SLCTR has been a key stimulus to a resurgent interest in clinical research among the Sri Lankan research community. The SLCTR is working together with its partner stakeholders to facilitate research in the country, and to ensure that clinical trials conducted in Sri Lanka meet the highest ethical and scientific standards. PMID:21894616

Ranawaka, Udaya K; Goonaratna, Colvin

2011-01-01

309

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

Science.gov (United States)

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

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

2013-01-01

310

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

311

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

Directory of Open Access Journals (Sweden)

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

Burgess LJ

2011-09-01

312

Should desperate volunteers be included in randomised controlled trials?  

OpenAIRE

Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguements that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its eth...

Allmark, P.; Mason, S.

2006-01-01

313

The Role of Tax Administration Lawyers in Criminal Trials  

OpenAIRE

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

Pe?clat, Me?lanie

2013-01-01

314

A surplus of positive trials: weighing biases and reconsidering equipoise  

OpenAIRE

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

Felson, David T.; Glantz, Leonard

2004-01-01

315

Analysis of Safety from a Human Clinical Trial with Pterostilbene  

OpenAIRE

Objectives. The purpose of this trial was to evaluate the safety of long-term pterostilbene administration in humans. Methodology. The trial was a prospective, randomized, double-blind placebo-controlled intervention trial enrolling patients with hypercholesterolemia (defined as a baseline total cholesterol ?200?mg/dL and/or baseline low-density lipoprotein cholesterol ?100?mg/dL). Eighty subjects were divided equally into one of four groups: (1) pterostilbene 125?mg twice daily, (2...

Riche, Daniel M.; Mcewen, Corey L.; Riche, Krista D.; Sherman, Justin J.; Wofford, Marion R.; David Deschamp; Michael Griswold

2013-01-01

316

Disability as an outcome in MS clinical trials.  

OpenAIRE

BACKGROUND: Inferences about long-term effects of therapies in multiple sclerosis (MS) have been based on surrogate markers studied in short-term trials. Preventing progressive disability is the key therapeutic goal but there remains no validated definition for its measurement in a trial context. Meanwhile, MS trials continue to shorten and to depend on unvalidated surrogates. Since there have been no treatment claims for improving unremitting disability, worsening of disability in the placeb...

Ebers, Gc; Heigenhauser, L.; Daumer, M.; Lederer, C.; Noseworthy, Jh

2008-01-01

317

Incorporating Clinical Trial Data Into Daily Cancer Care  

OpenAIRE

The objective of clinical trials is to determine the effectiveness and safety of specific interventions. Regulatory agencies, clinicians, and patients depend on clinical trials because they provide the most reliable information about treatment outcomes. The ability to predict how a patient may respond to a given treatment and what potential types, degree, and frequency of adverse events could occur is invaluable. Although data from clinical trials can determine effective treatment options for...

Pelusi, Jody

2012-01-01

318

A Brief History of Placebos and Clinical Trials in Psychiatry  

OpenAIRE

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

Shorter, Edward

2011-01-01

319

Key Concepts of Clinical Trials: A Narrative Review  

OpenAIRE

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

320

Implications of HIV PrEP Trials Results  

OpenAIRE

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

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

2011-01-01

321

Application of remote sensing to agricultural field trials.  

OpenAIRE

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.

1993-01-01

322

Clinical Trials Resources for Advocates | accrualnet.cancer.gov  

Science.gov (United States)

Recently, we had a question from an AccrualNet member regarding clinical trial resources for advocates. While AccrualNet is targeted toward clinical trialists on the front lines, it is also a helpful tool for others who may not be directly recruiting participants to trials, but who are also considered to be on the front lines for accrual. They are the patient and clinical trial advocates.

323

Clinical trial outcome in neuropathic pain: relationship to study characteristics.  

DEFF Research Database (Denmark)

BACKGROUND: Several recent randomized clinical trials have found that the medications being evaluated for neuropathic pain did not significantly differ from placebo for the primary efficacy endpoint, despite encouraging results from prior preclinical and clinical studies. It is unclear whether these trials were unsuccessful because the medications truly lack efficacy or whether characteristics of the trials compromised the demonstration of treatment benefits. OBJECTIVE: To identify factors associated with positive (i.e., favors medication) vs negative outcomes of placebo-controlled neuropathic pain trials. METHODS: We examined study characteristics associated with positive vs negative clinical trial outcomes for neuropathic pain treatments using the information provided in a comprehensive meta-analysis and additional ratings for 106 clinical trials. RESULTS: Univariate analyses indicated that the results of medication vs placebo comparisons were more likely to be positive when medication response rates were greater, placebo response rates were lower, and studies were published earlier. In a multivariate analysis performed to identify independent contributions of study characteristics to trial outcomes, greater medication response, reduced placebo response, and larger sample sizes were each uniquely associated with positive outcomes. In addition, greater medication response rates and parallel groups designs were each independently associated with greater placebo response rates. CONCLUSIONS: The results suggest that study characteristics may contribute to the outcomes of clinical trials of treatments for neuropathic pain and provide an impetus for investigating strategies for decreasing placebo response rates and thereby possibly increasing the likelihood of positive outcomes in trials of efficacious treatments.

Katz, Jennifer; Finnerup, Nanna B

2008-01-01

324

The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS trial  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II have demonstrated a mortality benefit of ?-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of ?-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction.

Bristow Michael R

2001-02-01

325

Randomized trials in the treatment of Barrett's esophagus.  

Science.gov (United States)

Treatment for Barrett's esophagus (BE) has consisted of medical treatment (acid suppression medications), surgery (fundoplication) and endoscopic ablative techniques (photodynamic therapy, argon plasma coagulation and multipolar electrocoagulation). Despite the large number of clinical trials of the efficacy of different therapeutic modalities, there is a paucity of published randomized controlled trials. The aim of this review is to evaluate the published randomized therapeutic trials in patients with BE. A comprehensive MEDLINE search was performed to review randomized clinical trials of different therapeutic modalities in BE. Only eight randomized studies have been published. The eight randomized studies reviewed include: two trials that evaluated medical and surgical therapy; two placebo controlled trials for photodynamic therapy (PDT); one placebo controlled trial comparing argon plasma coagulation (APC) versus surveillance; two trials comparing PDT versus APC; and one trial comparing APC versus multipolar electrocoagulation (MPEC). All the studies are prospective, however only one study is double-blinded. Each study has a small sample size, uses a different population of BE patients (dysplasia versus no dysplasia, short segment BE versus long segment BE), has different defined endpoints (endoscopic ablation of BE, number of treatments required for endoscopic ablation of BE, and elimination of high grade dysplasia) and the methodology for the treatment modalities is different among the studies. Though the data to support the use of endoscopic ablative techniques in the treatment of BE are promising, more rigorous double-blind and larger, well designed randomized studies are required to draw any definitive conclusions. PMID:16197527

Faybush, E M; Sampliner, R E

2005-01-01

326

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

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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

327

Gateways to clinical trials. March 2003.  

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 devlopment protal, http://integrity.prous.com. This issue focuses on the following selection of drugs: AAV-CF, adalimumab, ademetionine, afeletecan hydrochloride, agomelatine, alemtuzumab, almotriptan, amdoxovir, aplidine, aranose, arsenic sulfide, atazanavir, atlizumab; Bimatoprost, BMS-181176, BMS-188667, bortezomib, bryostatin 1; Combretastatin A-4 phosphate; Darbepoetin alfa, darusentan, deferasirox, desloratadine, DTaP-HBV-IPV/Hib-vaccine, DTI-0009; Eculizumab, edodekin alfa, emtricitabine, enfuvirtide, epoetin, esomeprazole magnesium etoricoxib; Fampridine, fenretinide, FR-146687; Galiximab, gamma-Hydroxybutyrate sodium, ganirelix acetate, gefitinib, Gemtuzumab ozogamicin, gimatecan; HEA125xOKT3, hIL-13-PE38QQR, HSV-2 theracine, Hu14.18-IL-2, human gammaglobulin; Idraparinux sodium, imatinib mesylate, IMiD3, insulin detemir, interleukin-4, irofulven, ISAtx-247; JT-1001; Levetiracetam, levosimendan, liposomal doxorubicin, liposomal vincristine sulfate, lixivaptan, lopinavir, lumiracoxib; Maxacalcitol, melatonin, midostaurin, MLN-518; Neridronic acid, nesiritide, nitronaproxen; Oblimersen sodium, oregovomab; PEG-filgrastim polyglutamate paclitaxel, prasterone, pregabalin; Rosuvastatin calcium, rotigotine hydrochloride; SGN-30; T-1249, tenofovir disoproxil fumarate, teriparatide, tiotropium bromide, tipranavir, TMC-114, trabectedin, transdermal selegiline; UK-427857; Valdecoxib, valganciclovir hydrochloride, vardenafil, vatalanib succinate, vincristine sulfate TCS; Zofenopril calcium. PMID:12731460

Bayés, M; Rabasseda, X; Prous, J R

2003-03-01

328

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 riodic 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

329

The challenges and opportunities of conducting a clinical trial in a low resource setting: The case of the Cameroon mobile phone SMS (CAMPS trial, an investigator initiated trial  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Conducting clinical trials in developing countries often presents significant ethical, organisational, cultural and infrastructural challenges to researchers, pharmaceutical companies, sponsors and regulatory bodies. Globally, these regions are under-represented in research, yet this population stands to gain more from research in these settings as the burdens on health are greater than those in developed resourceful countries. However, developing countries also offer an attractive setting for clinical trials because they often have larger treatment naive populations with higher incidence rates of disease and more advanced stages. These factors can present a reduction in costs and time required to recruit patients. So, balance needs to be found where research can be encouraged and supported in order to bring maximum public health benefits to these communities. The difficulties with such trials arise from problems with obtaining valid informed consent, ethical compensation mechanisms for extremely poor populations, poor health infrastructure and considerable socio-economic and cultural divides. Ethical concerns with trials in developing countries have received attention, even though many other non-ethical issues may arise. Local investigator initiated trials also face a variety of difficulties that have not been adequately reported in literature. This paper uses the example of the Cameroon Mobile Phone SMS trial to describe in detail, the specific difficulties encountered in an investigator-initiated trial in a developing country. It highlights administrative, ethical, financial and staff related issues, proposes solutions and gives a list of additional documentation to ease the organisational process.

Ongolo-Zogo Pierre

2011-06-01

330

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

OpenAIRE

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

331

The “House Calls” Trial: A Randomized Controlled Trial to Reduce Racial Disparities in Live Donor Kidney Transplantation: Rationale and Design  

OpenAIRE

Despite a substantially lower rate of live donor kidney transplantation among Black Americans compared to White Americans, there are few systematic efforts to reduce this racial disparity. This paper describes the rationale and design of a randomized controlled trial aims evaluating the comparative effectiveness of three different educational interventions for increasing live donor kidney transplantation in Black Americans. This trial is a single-site, urn-randomized controlled trial with a p...

Rodrigue, James R.; Pavlakis, Martha; Egbuna, Ogo; Paek, Mathew; Waterman, Amy D.; Mandelbrot, Didier A.

2012-01-01

332

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

Directory of Open Access Journals (Sweden)

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

333

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

OpenAIRE

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

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

2011-01-01

334

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

Directory of Open Access Journals (Sweden)

Full Text Available Background: in a previous paper we reported the statistical analysis and other distribution data of a homeopathic pathogenetic trial (HPT of Plumbum metallicum 30cH carried out by our group. However, at that time we did not report the resulting pure materia medica, i.e., the totality of symptoms elicited by the tested medicine on healthy volunteers. Aim: to communicate to the homeopathic community the full record of symptoms collected in our HPT of Plb. Methods: methods to collect and select symptoms have been reported in the previous paper. In synthesis were excluded all previous common symptoms of volunteers, even with slight differences, and selected only those that were really unknown, never seen, unusual or very strange for the prover. In this paper special emphasis was given to new symptoms as well as unusual or repeated dreams, while in the previous paper special emphasis was given to repeated and crossed symptoms. Results: symptoms are reported in their chronological order of appearance in each volunteer. 37 new symptoms were found, useful to update Homeopathic Repertories. It is also included a synthesis of the original HPT of Plb carried out in 1828 in order to make available the full experimental materia medica currently existing. Conclusions: the new HPT, besides widening the pathogenetic picture of Plb (skin and mucosae symptoms, also allowed us to give new and deeper meanings to some of the symptoms reported in the original trial, such as Anxiety, Activity, Depression, Slowness, Gastro-oesophageal problems, Colitis. The dreams complete the remedy image, mainly in work, religion and sexual themes. Up to the present time there is no peer-reviewed publication devoted to HPTs. For this reason, researchers are compelled to publish HPTs as private editions. This results in poor control of the quality of publications and a lack of standards on how to present the results of HPTs.

Christa Pichler

2011-03-01

335

Potential pitfalls in the design and reporting of clinical trials. | accrualnet.cancer.gov  

Science.gov (United States)

Factors that can lead to insufficient recruitment to a clinical trial include overestimation of support for the trial, failure to engage the target population in trial design, and inaccurate estimates of appropriate sample size and trial duration. Improved public acceptance of a trial can be a major factor in ensuring participation.

336

Escritas de luz: Der Prozess/ The Trial  

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Full Text Available ResumoLiteratura e cinema constituem duas linguagens distintas, irredutíveis. Suas gramáticas, léxicos e sintaxes são radicalmente diferentes. Toda imagem, e a fortiori toda sucessão de imagens, é necessariamente, inevitavelmente, “infiel”ao texto. No seu filme The trial, Orson Welles apropriou-se do romance de Kafka — O processo — para recriá-lo nos seus próprios termos. O romance não exprime uma mensagem política ou doutrinária; mas, sobretudo, um certo estado de espírito antiautoritário. Reencontramos, sob uma outra forma,e com outros meios estéticos, esse mesmo estado de espírito no filme.AbstractLiterature and cinema are two distinct and irreducible languages. Their grammar, vocabulary and syntax are radically different. All image, and more so any succession ofimages is necessarily, inevitably, “unfaithful” to the text. Inhis movie The trial Orson Welles took possession of Kafka’s novel Der Prozess and re-created it in his own terms. The novel does not express a political or doctrinaire message, but rather a certain anti-authoritarian state of mind. One finds, in a different form, and with other aesthetic means, the samestate of mind in the movie.ResuméeLittérature et cinéma constituent deux langages distincts, irréductibles. Leur grammaire, leur lexique, leur syntaxe sont radicalement différents. Toute image, et à fortiori toute succession d’images est nécessairement,  inévitablement, “ infidèle ” au texte. Dans son film The trial Orson Welles s’est approprié du roman de Kafka — Le procès — pour le récréer dans ses propres termes. Le roman n’exprime pas un message politique ou doctrinaire, mais plutôt un certain état d’esprit anti-autoritaire. On retrouve, sous une autreforme, et avec d’autres moyens esthétiques, ce même état d’esprit dans le film.Michael Löwy é um sociólogo nascido no Brasil, formado em Ciências Sociais na Universidade de São Paulo e radicado na França. Diretor emérito de pesquisas do Centre National de la Recherche Scientifique (CNRS, foi homenageado com a medalha de prata do CNRS em Ciências Sociais no ano de 1994. É autor de Walter Benjamin: aviso de incêndio (2005, Franz Kafka: sonhador insubmisso (2005, Lucien Goldmann ou a dialética da totalidade (2009, A teoria da revolução no jovem Marx (2012 e organizador de Revoluções (2009 e Capitalismo como religião (2013, de Walter Benjamin.

Michael Löwy

2015-02-01

337

DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative Treatment. A MULTICENTER RANDOMISED CLINICAL TRIAL  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses. Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management. We, therefore, constructed a randomised clinical trial comparing these two treatment strategies. Methods/design The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management. Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used. The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years. Discussion Considering the high incidence and the multicenter design of this study, it may be assumed that the number of patients needed for this study (n = 214, may be gathered within one and a half year. Depending on the expertise and available equipment, we prefer to perform a laparoscopic resection on patients randomised for elective surgery. Should this be impossible, an open technique may be used as this also reflects the current situation. Trial Registration (Trial register number: NTR1478

van de Wall Bryan JM

2010-08-01

338

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

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

Whitehead Craig

2008-02-01

339

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

340

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

341

Book review: writing history in international criminal trials  

OpenAIRE

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

342

Barriers to clinical trial recruitment in head and neck cancer.  

Science.gov (United States)

Despite substantial improvements in the treatment of head and neck cancer (HNC) over the last two decades, overall survival rates remain unsatisfactory. The need for improved therapeutic approaches for HNC patients is hampered by low patient recruitment rates in HNC clinical trials, particularly Phase III studies. Based on an analysis of ClinicalTrials.gov, this article identified several potential barriers to patient recruitment in Phase I-III clinical trials of treatments for HNC. Of 694 HNC trials identified on ClinicalTrials.gov from multiple sites worldwide, 91 (13.1%) were identified as either terminated, suspended or withdrawn; 27.5% (n=25) of these did not provide an additional reason for stopping recruitment early. Insufficient accrual was the most common reason provided for trial closure (n=23, 25.3%). Possible reasons for the insufficient accrual rates include the inappropriate designs of these studies given the change in HNC tumour biology in the last 20years, the low incidence of the disease, and the diversity of treatment standards and referral processes across countries. Given the low numbers of drugs approved for HNC, it is important that barriers to recruitment in this field are addressed to allow new therapies to be successfully validated in completed clinical trials. This review discusses how these accrual challenges may be overcome with changes to clinical trial designs, including their adaptation to specific subgroups, such as human papillomavirus-positive patients. PMID:25593017

Haddad, Robert I; Chan, Anthony T C; Vermorken, Jan B

2015-03-01

343

Use of 'sham' radiotherapy in randomized clinical trials  

International Nuclear Information System (INIS)

The objective of this systematic review was to identify quality trials that use sham radiotherapy in their design and review them to determine its potential value. The Cochrane Library, Pubmed and a Reference Search served as data sources. Trials were included if they met a minimum quality score of 3 on a validated assessment instrument (which assesses randomization, control and blinding) and if they compared sham radiotherapy to active treatment. External beam therapy and brachytherapy trials were considered. Twenty-six trials were identified, collectively including 2663 participants in the period of 1970-2004. All the trials studied the value of radiotherapy for treatment or prevention of benign diseases, including multiple sclerosis, coronary artery restenosis, age-related macular degeneration and Graves' ophthalmopathy. There were no trials relating to the use of radiotherapy in the treatment of malignancy. This review showed that it is possible to carry out sham radiotherapy with due regard for ethical concerns, with effective blinding and high levels of patient acceptance. Large sample sizes with multicentre trial designs were achievable. Although the statistical philosophy for using sham radiotherapy in trials is legitimate, it is no longer routinely used.

344

Facilitating large-scale clinical trials: in Asia.  

Science.gov (United States)

The number of clinical trials conducted in Asian countries has started to increase as a result of expansion of the pharmaceutical market in this area. There is a growing opportunity for large-scale clinical trials because of the large number of patients, significant market potential, good quality of data, and the cost effective and qualified medical infrastructure. However, for carrying out large-scale clinical trials in Asia, there are several major challenges, including the quality control of data, budget control, laboratory validation, monitoring capacity, authorship, staff training, and nonstandard treatment that need to be considered. There are also several difficulties in collaborating on international trials in Asia because Asia is an extremely diverse continent. The major challenges are language differences, diversity of patterns of disease, and current treatments, a large gap in the experience with performing multinational trials, and regulatory differences among the Asian countries. In addition, there are also differences in the understanding of global clinical trials, medical facilities, indemnity assurance, and culture, including food and religion. To make regional and local data provide evidence for efficacy through the standardization of these differences, unlimited effort is required. At this time, there are no large clinical trials led by urologists in Asia, but it is anticipated that the role of urologists in clinical trials will continue to increase. PMID:21062654

Choi, Han Yong; Ko, Jae-Wook

2010-01-01

345

An Overview of NCI’s National Clinical Trials Network  

Science.gov (United States)

Information about the National Clinical Trial Network’s (NCTN) structure, a summary of the changes taking place as a result of the NCTN launch, and a synopsis of how these changes build on the success of the Cooperative Group program and will improve the speed and efficiency of cancer clinical trials.

346

Trial by Jury in Russian Military Courts  

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Full Text Available 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 impartiality in Russian military courts with participation of lay decision-makers. In particular, the article will analyze two high-profile cases which resulted in acquittals of Russian officers accused of killing several Chechen civilians during counter-terrorist operations in Chechnya.

Nikolai P. Kovalev

2008-07-01

347

ATLAS Canada lightpath data transfer trial  

CERN Document Server

Emerging grids play a significant role in the computational, data, storage, and network requirements of high energy physics experiments coming online in the next few years. One such requirement, the bulk transfer of data over advanced high speed optical networks is necessary as such experiments are highly distributed with resources and participants from research laboratories and institutions spanning the globe. This trial at the iGrid 2002 conference attempts to stress the feasibility of high speed bulk data transfer over an end-to-end lightpath, a dedicated point-to-point optical link. Specifically, the objective was to transfer 1 TB of Monte Carlo data from TRIUMF in Vancouver, Canada, to CERN in Geneva, Switzerland. A rate equivalent to transferring a full CD of data every 8 s was achieved. (15 refs).

Kost, C J; Caron, B; Hong, W; 10.1016/S0167-739X(03)00082-7

2003-01-01

348

Parabolic Trough Solar Collector Initial Trials  

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Full Text Available This paper discusses initial trials of parabolic trough solar collector (PTSC in Bandung. PTSC model consists of concentrator, absorber and tracking system. Concentrator designs are made with 2m aperture width, 6m length and 0.75m focal distance. The design is equipped with an automatic tracking system which is driven using 12V and 24Watt DC motor with 0.0125rpm rotational speed. Absorber/receiver is designed with evacuated tube type, with 1 inch core diameter and tube made of AISI304 and coated with black oxide, the outer tube is borosilicate glass with a 70 mm diameter and 1.5 m length. Working fluid stored in single type of thermal storage tank, a single phase with 37.7 liter volume. PTSC model testing carried out for 2 hours and 10 minutes produces heat output and input of 11.5 kW and 0.64 kW respectively. 

Ghalya Pikra

2011-12-01

349

Eurados trial performance test for photon dosimetry  

DEFF Research Database (Denmark)

Within the framework of the EURADOS Action entitled Harmonisation and Dosimetric Quality Assurance in Individual Monitoring for External Radiation, trial performance tests for whole-body and extremity personal dosemeters were carried out. Photon, beta and neutron dosemeters were considered. This paper summarises the results of the whole-body photon dosemeter test. Twenty-six dosimetry services from all EU Member States and Switzerland participated. Twelve different radiation fields were used to simulate various workplace irradiation fields. Dose values from 0.4 mSv to 80 mSv were chosen. From 312 single results, 26 fell outside the limits of the trumpet curve and 32 were outside the range 1/1.5 to 1.5. Most outliers resulted from high energy R-F irradiations without electronic equilibrium. These fields are not routinely encountered by many of the participating dosimetry services. If the results for this field are excluded, most participating services satisfied the evaluation criteria.

Stadtmann, H.; Bordy, J.M.

2001-01-01

350

Mechanical ventilation: lessons from the ARDSNet trial  

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Full Text Available Abstract The acute respiratory distress syndrome (ARDS is an inflammatory disease of the lungs characterized clinically by bilateral pulmonary infiltrates, decreased pulmonary compliance and hypoxemia. Although supportive care for ARDS seems to have improved over the past few decades, few studies have shown that any treatment can decrease mortality for this deadly syndrome. In the 4 May 2000 issue of New England Journal of Medicine, the results of an NIH-sponsored trial were presented; they demonstrated that the use of a ventilatory strategy that minimizes ventilator-induced lung injury leads to a 22% decrease in mortality. The implications of this study with respect to clinical practice, further ARDS studies and clinical research in the critical care setting are discussed.

Marco Ranieri V

2000-08-01

351

The Svalbard shoreline oilspill field trials  

International Nuclear Information System (INIS)

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

352

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

353

Trial watch: Peptide vaccines in cancer therapy.  

Science.gov (United States)

Prophylactic vaccination constitutes one of the most prominent medical achievements of history. This concept was first demonstrated by the pioneer work of Edward Jenner, dating back to the late 1790s, after which an array of preparations that confer life-long protective immunity against several infectious agents has been developed. The ensuing implementation of nation-wide vaccination programs has de facto abated the incidence of dreadful diseases including rabies, typhoid, cholera and many others. Among all, the most impressive result of vaccination campaigns is surely represented by the eradication of natural smallpox infection, which was definitively certified by the WHO in 1980. The idea of employing vaccines as anticancer interventions was first theorized in the 1890s by Paul Ehrlich and William Coley. However, it soon became clear that while vaccination could be efficiently employed as a preventive measure against infectious agents, anticancer vaccines would have to (1) operate as therapeutic, rather than preventive, interventions (at least in the vast majority of settings), and (2) circumvent the fact that tumor cells often fail to elicit immune responses. During the past 30 y, along with the recognition that the immune system is not irresponsive to tumors (as it was initially thought) and that malignant cells express tumor-associated antigens whereby they can be discriminated from normal cells, considerable efforts have been dedicated to the development of anticancer vaccines. Some of these approaches, encompassing cell-based, DNA-based and purified component-based preparations, have already been shown to exert conspicuous anticancer effects in cohorts of patients affected by both hematological and solid malignancies. In this Trial Watch, we will summarize the results of recent clinical trials that have evaluated/are evaluating purified peptides or full-length proteins as therapeutic interventions against cancer. PMID:23264902

Vacchelli, Erika; Martins, Isabelle; Eggermont, Alexander; Fridman, Wolf Hervé; Galon, Jerome; Sautès-Fridman, Catherine; Tartour, Eric; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

2012-12-01

354

Contemporary issues in clinical trials for medulloblastoma  

International Nuclear Information System (INIS)

Medulloblastoma is the seminal pediatric brain tumor providing opportunities for clinical investigation to define improved treatment strategies for both disease control and ultimate functional integrity. Recent studies addressing neuraxis radiation dose provide a 'standard' for conventional therapy while establishing 5-year disease control rates for 'favorable' or 'low risk' presentations approximating 60% following surgery and irradiation. A highly visible recent report of combined post-operative irradiation and chemotherapy incorporating a platinum- and alkylator-based regimen indicates 5-year disease control approaching 90% in localized medulloblastoma. Despite unfavorable outcome with reduced-dose neuraxis irradiation in earlier trials, further data from recent studies suggest the addition of post-operative chemotherapy to similarly reduced-dose neuraxis irradiation (23.4 Gy) in 'favorable' presentations may result in progression-free survival rates at least equivalent to those achieved with full-dose neuraxis irradiation (36 Gy) absent chemotherapy. The panel will (1) provide updated information regarding the major clinical trials that form the basis for current and planned protocols and (2) debate the therapeutic modifications appropriate for contemporary clinical investigations. Critical in planning future studies in the analysis of risk factors that may identify 'favorable' patients versus 'high risk' patients. Risk-related studies appropriately address maintalated studies appropriately address maintaining or improving current disease control rates in the context of diminishing late treatment sequelae for 'favorable' presentations. For those identified as 'high risk' (e.g., patients with disease beyond the primary site), studies are in development that increase the intensity of chemotherapy and explore modifications of radiation delivery. Study designs that permit assessment of innovations in surgical, radiotherapeutic, and chemotherapeutic approaches will be presented and debated by the panelists representing the two cooperative/competing modalities and neuro-oncology biostatistics

355

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

356

Inadequate description of educational interventions in ongoing randomized controlled trials  

Directory of Open Access Journals (Sweden)

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

Pino Cécile

2012-05-01

357

Clinical outcomes in clinical trials of anti-HIV treatment  

DEFF Research Database (Denmark)

Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?

Reekie, J; Mocroft, A

2007-01-01

358

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

359

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

OpenAIRE

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

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

2013-01-01

360

Prevention of atherosclerotic complications: controlled trial of ketanserin. Prevention of Atherosclerotic Complications with Ketanserin Trial Group.  

OpenAIRE

STUDY OBJECTIVE--To determine whether ketanserin, an antagonist at the serotonin receptor, prevents important vascular events such as death, myocardial infarction, major stroke, and amputation of a leg in patients with claudication. DESIGN--Double blind, randomised, placebo controlled trial after a single blind run in period of placebo treatment for one month. SETTING--One hundred and forty seven outpatient clinics in 14 countries. PATIENTS--Total of 3899 patients over 40 years old who had ha...

1989-01-01

361

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

OpenAIRE

Abstract Background The objectives are to compare the effectiveness of cell phone-supported SMS messaging to standard care on adherence, quality of life, retention, and mortality in a population receiving antiretroviral therapy (ART) in Nairobi, Kenya. Methods and Design A multi-site randomized controlled open-label trial. A central randomization centre provided opaque envelopes to allocate treatments. Patients initiating ART at three comprehensive care clinics in Kenya will be randomized to ...

Blake, Ball T.; Ngugi Elizabeth; Estambale Benson; Nguti Rosemary; Barasa Samson; Karanja Sarah; Habyarimana James; Jack William; Chung Michael; Ritvo Paul; Kariri Antony; Mills Edward J; Lester Richard T; Thabane Lehana; Kimani Joshua

2009-01-01

362

Clustering in surgical trials - database of intracluster correlations  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Randomised trials evaluation of surgical interventions are often designed and analysed as if the outcome of individual patients is independent of the surgeon providing the intervention. There is reason to expect outcomes for patients treated by the same surgeon tend to be more similar than those under the care of another surgeon due to previous experience, individual practice, training, and infrastructure. Such a phenomenon is referred to as the clustering effect and potentially impacts on the design and analysis adopted and thereby the required sample size. The aim of this work was to inform trial design by quantifying clustering effects (at both centre and surgeon level for various outcomes using a database of surgical trials. Methods Intracluster correlation coefficients (ICCs were calculated for outcomes from a set of 10 multicentre surgical trials for a range of outcomes and different time points for clustering at both the centre and surgeon level. Results ICCs were calculated for 198 outcomes across the 10 trials at both centre and surgeon cluster levels. The number of cases varied from 138 to 1370 across the trials. The median (range average cluster size was 32 (9 to 51 and 6 (3 to 30 for centre and surgeon levels respectively. ICC estimates varied substantially between outcome type though uncertainty around individual ICC estimates was substantial, which was reflected in generally wide confidence intervals. Conclusions This database of surgical trials provides trialists with valuable information on how to design surgical trials. Our data suggests clustering of outcome is more of an issue than has been previously acknowledged. We anticipate that over time the addition of ICCs from further surgical trial datasets to our database will further inform the design of surgical trials.

Cook Jonathan A

2012-01-01

363

Minehound TM trials in Cambodia, Bosnia, and Angola  

Science.gov (United States)

This paper describes the trials of the MINEHOUND TM dual sensor, land mine detector carried out in Cambodia, Bosnia and Angola. MINEHOUND TM has been developed for use in humanitarian demining as a means of improving the efficiency of clearance operations. The trials were sponsored by the UK Department for International Development (DFID). ERA Technology Ltd conducted the trials, which were monitored by staff drawn from the countries participating in the International Test and Evaluation Programme (ITEP) for humanitarian de-mining. Experienced deminers from the Mines Advisory Group (MAG) and Norwegian Peoples Aid (NPA) used the pre-production units in live minefields. The objectives of the trial were: 1. To record information on the performance of MINEHOUND TM when used in a live minefield. 2. To determine the reduction in False Alarm Rate (FAR) that could be achieved using a dual sensor mine detector. The trials were conducted in three mine-affected countries for a period of eight weeks per country; the programme of trials ran from July 2005 to December 2005, with an additional smaller trial in late February 2006. The results of the trials showed that MINEHOUND TM achieved 100% detection of the mines encountered and an improvement in FAR of better than 5:1 compared with a basic metal detector. The trials enabled optimisation of the production design and clearly demonstrated that new technology can be brought to humanitarian clearance operations in a safe and controlled manner. As a result of the highly successful trials, Vallon and ERA will produce the MINEHOUND TM (Type number VMR1) starting in Q3 of 2006.

Daniels, David J.; Curtis, Paul

2006-05-01

364

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

365

Do current clinical trials meet society's needs?: a critical review of recent evidence.  

Science.gov (United States)

This paper describes some important controversies regarding the current state of clinical trials research in cardiology. Topics covered include the inadequacy of trial research on medical devices, problems with industry-sponsored trials, the lack of head-to-head trials of new effective treatments, the need for wiser handling of drug safety issues, the credibility (or lack thereof) of trial reports in medical journals, problems with globalization of trials, the role of personalized (stratified) medicine in trials, the need for new trials of old drugs, the need for trials of treatment withdrawal, the importance of pragmatic trials of treatment strategies, and the limitations of observational comparative effectiveness studies. All issues are illustrated by recent topical trials in cardiology. Overall, we explore the extent to which clinical trials, as currently practiced, are successful in meeting society's expectations. PMID:25301467

Pocock, Stuart J; Gersh, Bernard J

2014-10-14

366

Disclosure of investigators' recruitment performance in multicenter clinical trials : a further step for research transparency  

DEFF Research Database (Denmark)

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

Dal-Ré, Rafael; Moher, David

2011-01-01

367

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

Science.gov (United States)

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

2012-02-09

368

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

369

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

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

Callahan Christopher M

2012-06-01

370

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

DEFF Research Database (Denmark)

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

Toft, Palle; Olsen, Hanne Tanghus

2014-01-01

371

The placebo response in clinical trials: more questions than answers.  

Science.gov (United States)

Meta-analyses and re-analyses of trial data have not been able to answer some of the essential questions that would allow prediction of placebo responses in clinical trials. We will confront these questions with current empirical evidence. The most important question asks whether the placebo response rates in the drug arm and in the placebo arm are equal. This 'additive model' is a general assumption in almost all placebo-controlled drug trials but has rarely been tested. Secondly, we would like to address whether the placebo response is a function of the likelihood of receiving drug/placebo. Evidence suggests that the number of study arms in a trial may determine the size of the placebo and the drug response. Thirdly, we ask what the size of the placebo response is in 'comparator' studies with a direct comparison of a (novel) drug against another drug. Meta-analytic and experimental evidence suggests that comparator studies may produce higher placebo response rates when compared with placebo-controlled trials. Finally, we address the placebo response rate outside the laboratory and outside of trials in clinical routine. This question poses a serious challenge whether the drug response in trials can be taken as evidence of drug effects in clinical routine. PMID:21576146

Enck, Paul; Klosterhalfen, Sibylle; Weimer, Katja; Horing, Björn; Zipfel, Stephan

2011-06-27

372

Construction of ethics in clinical research: clinical trials registration  

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

C. A. Caramori

2007-01-01

373

Incorporating clinical trial data into daily cancer care.  

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The objective of clinical trials is to determine the effectiveness and safety of specific interventions. Regulatory agencies, clinicians, and patients depend on clinical trials because they provide the most reliable information about treatment outcomes. The ability to predict how a patient may respond to a given treatment and what potential types, degree, and frequency of adverse events could occur is invaluable. Although data from clinical trials can determine effective treatment options for patients, it is the explanation of what to expect from treatment and how it may affect quality of life that will determine which option a patient chooses. Translating clinical trial data into "real life" can be challenging for the oncology advanced practitioner (AP) because primary and secondary endpoints may differ among clinical trials. This variability can produce confusion when comparing, contrasting, and translating clinical evidence into clinical practice. This article reviews clinical trial endpoints and surrogate markers and describes how findings can influence decision-making and patient care. With social media increasing patients' awareness and encouraging active participation in their own care, it is imperative that APs be able to articulate clinical trial outcomes along with their strengths, limitations, and life impact. PMID:25031968

Pelusi, Jody

2012-11-01

374

Bayesian monitoring of phase II trials in cancer chemoprevention.  

Science.gov (United States)

Early randomized Phase II cancer chemoprevention trials which assess short-term biological activity are critical to the decision process to advance to late Phase II/Phase III trials. We have adapted published Bayesian interim analysis methods (Spiegelhalter et al., J. R. Statist. Soc A, 1994; 157: 357-416) which give greater flexibility and simplicity of inference to the monitoring of randomized controlled Phase II trials using intermediate endpoints. The Bayesian stopping rule is designed to stop the trial more quickly when the evidence suggests ineffectiveness rather than when it suggests biological activity, thus allowing resources to be concentrated on those agents that show the most promise in this early stage of testing. We investigate frequentist performance characteristics of the proposed method through simulation of randomized placebo controlled trials with a growth factor intermediate end-point using mean and variance values derived from the literature. Simulation results show expected error rates and trial size similar to other commonly used group sequential methods for this setting. These results suggest that the Bayesian approach to interim analysis is well suited for monitoring small randomized controlled Phase II chemoprevention trials for early detection of either inactive or promising agents. PMID:10465313

Cronin, K A; Freedman, L S; Lieberman, R; Weiss, H L; Beenken, S W; Kelloff, G J

1999-08-01

375

Sample sizes in dosage investigational clinical trials: a systematic evaluation.  

Science.gov (United States)

The main purpose of investigational phase II clinical trials is to explore indications and effective doses. However, as yet, there is no clear rule and no related published literature about the precise suitable sample sizes to be used in phase II clinical trials. To explore this, we searched for clinical trials in the ClinicalTrials.gov registry using the keywords "dose-finding" or "dose-response" and "Phase II". The time span of the search was September 20, 1999, to December 31, 2013. A total of 2103 clinical trials were finally included in our review. Regarding sample sizes, 1,156 clinical trials had accounting for 55.0% of the studies reviewed, and only 17.2% of the studies reviewed had >100 patient cases in a single group. Sample sizes used in parallel study designs tended to be larger than those of crossover designs (median sample size 151 and 37, respectively). In conclusion, in the earlier phases of drug research and development, there are a variety of designs for dosage investigational studies. The sample size of each trial should be comprehensively considered and selected according to the study design and purpose. PMID:25609916

Huang, Ji-Han; Su, Qian-Min; Yang, Juan; Lv, Ying-Hua; He, Ying-Chun; Chen, Jun-Chao; Xu, Ling; Wang, Kun; Zheng, Qing-Shan

2015-01-01

376

Women's willingness to participate in microbicide trials in Northern Thailand.  

Science.gov (United States)

To assess women's interests and concerns regarding participation in trials of microbicides in Chiang Rai, Thailand, we administered structured questionnaires. Before answering the questionnaire, women attended an educational session on microbicides and clinical trials. Of 370 participants, 82% correctly answered 8 or more of the 11 overall comprehension questions, indicating an adequate knowledge base among the women from which to answer questions about attitudes toward microbicide trials. The most common motivations for participating in a trial were "getting tested for HIV" and "doing something good for women's health." The greatest barrier to participation was women's fear that if they proposed use of a microbicide, their husbands might feel protected and thereby have more sex partners. Overall, 6.2% said they would be "definitely willing to participate," and 66.8% said they wanted to participate but wanted to think about it. Most women previously unacquainted with the concept of microbicides or clinical trial design displayed adequate knowledge of these subjects after the short educational session. If women's initial reactions are validated by actual willingness, surveys could prove valuable for selecting sites for microbicide trials, estimating enrollment rates, and tailoring trials to make them most acceptable to women. PMID:11588513

Tharawan, K; Manopaiboon, C; Ellertson, C; Limpakarnjanarat, K; Chaikummao, S; Kilmarx, P H; Blanchard, K; Coggins, C; Mastro, T D; Elias, C

2001-10-01

377

Motivation and frustration in cardiology trial participation: the patient perspective  

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

Silmara Meneguin

2012-01-01

378

Motivation and frustration in cardiology trial participation: the patient perspective  

Scientific Electronic Library Online (English)

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

Silmara, Meneguin; Luiz Antônio Machado, Cesar.

379

Collateral lessons from recent acute ischemic stroke trials.  

Science.gov (United States)

Numerous acute ischemic stroke trials have recently published detailed results, providing an opportunity to consider the role of collaterals in stroke pathophysiology and their influential effect on patient outcomes. Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS), the largest randomized controlled trial of device therapy to date, tested the potential augmentation of collateral perfusion. SYNTHESIS Expansion, Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE), and Interventional Management of Stroke (IMS) III chronicled the saga of endovascular therapy trialed against medical treatment for acute ischemic stroke. These recent randomized studies, however, largely neglect current device technology available for endovascular therapy as advanced by the TREVO2 and SOLITAIRE™(TM) FR With the Intention For Thrombectomy (SWIFT) studies. Such exhaustive efforts in recent trials have failed to introduce a new treatment for stroke that unequivocally improves patient outcomes. Collateral perfusion is widely recognized to vary across individuals in any population and exerts a dramatic effect on baseline variables including the time course of ischemic injury, stroke severity, imaging findings, and therapeutic opportunities. Similarly, collaterals have been recognized to influence recanalization, reperfusion, hemorrhagic transformation, and subsequent neurological outcomes after stroke. Collateral lessons may be gleaned from these trials, to expand consideration of overall study results and perhaps most importantly, alter ongoing and new trials in development. Detailed analyses of available information on collaterals from these trials demonstrate that collaterals may be more influential than the choice of treatment modality or intervention. PMID:24641715

Liebeskind, David S

2014-05-01

380

An evaluation of the results of neutron therapy trials  

International Nuclear Information System (INIS)

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

381

REDUCED MUSCLE PAIN INTENSITY RATING DURING REPEATED CYCLING TRIALS  

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

Frank E. Marino

2004-06-01

382

Consumer input into research: the Australian Cancer Trials website  

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

Butow Phyllis N

2011-06-01

383

Barriers to Participation in Cancer Prevention Clinical Trials  

Science.gov (United States)

Background Cancer prevention clinical trials seek to enroll individuals at increased risk for cancer. Little is known about attitudes among physicians and at-risk individuals towards cancer prevention clinical trials. We sought to characterize barriers to prevention trial participation among medical oncologists and first-degree relatives of their patients. Methods Physician participants were practicing oncologists in Pennsylvania. Eligible first-degree participants were adult relatives of a cancer patient being treated by one of the study physicians. The influence of perceived psychosocial and practical barriers on level of willingness to participate in cancer prevention clinical trials was investigated. Results Response rate was low among physicians, 137/478(29%), and modest among eligible first-degree relatives, 82/129(64%). Lack of access to an eligible population for prevention clinical trials was the most commonly cited barrier to prevention clinical trials among oncologists. Nearly half (45%) of first-degree relatives had not heard of cancer prevention clinical trials, but 68% expressed interest in learning more, and 55% expressed willingness to participate. In the proportional odds model, greater information source seeking/responsiveness (i.e. interest in learning more about clinical prevention trials from more information sources)(p=0.04), and having fewer psychosocial barriers (p=0.02) were associated with a greater willingness to participate. Conclusions Many individuals who may be at greater risk for developing cancer because of having a first-degree relative with cancer are unaware of the availability of clinical cancer prevention trials. Nonetheless, many perceive low personal risk associated with these studies, and are interested in learning more. PMID:20515420

Hall, Michael J; Egleston, Brian; Miller, Suzanne M.; Buzaglo, Joanne S.; Millard, Jennifer; Ridgway, Caroline; Damjanov, Nevena; Sprandio, John D.; Meropol, Neal J.

2010-01-01

384

Effects of a short outpatient rehabilitation treatment on disability of multiple sclerosis patients--a randomised controlled trial.  

Science.gov (United States)

It is well known that neurorehabilitation can reduce disability or improve handicap of people with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of a short period (6 weeks) of a tailored, individualised outpatient rehabilitation program in people with progressive MS. A randomised-controlled trial was undertaken in patients with primary and secondary progressive MS referred to the Centro Sclerosi Multipla of Catania. One hundred and eleven patients were assessed at baseline and at 12 weeks with validated measures of disability (Functional Independence Measure (FIM)) and impairment (Expanded Disability Status Scale (EDSS) and Functional Systems Scale). Of the 111, 58 were randomly assigned to the treatment group and 53 to the control group. All patients had been previously trained in a home exercise program. Both groups were well matched for age, sex, disease duration and severity, disability and quality of life (Short Form-36). At the end of 6 weeks patients allocated to the rehabilitation treatment group showed significant improvement in their level of disability compared with the control group,while the level of impairment did not change. Thirty-two patients of the treatment group and four of the control group improved on the FIM by two or more steps at 12 weeks (p<0.0001). An improvement by 1 EDSS step occurred in only two patients of the treatment group and in one patient of the control group. Benefits were maintained for a further six weeks. This study demonstrates that a short outpatient rehabilitation treatment improves disability of MS patients, without changing their impairment and confirms the effectiveness of rehabilitation in people with MS. PMID:12883930

Patti, Francesco; Ciancio, Maria Rita; Cacopardo, Manuela; Reggio, Ester; Fiorilla, Teresa; Palermo, Filippo; Reggio, Arturo; Thompson, Alan J

2003-07-01

385

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

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

Ivaldo Jesus Lima de Oliveira

2015-01-01

386

On an Approach to Bayesian Sample Sizing in Clinical Trials  

CERN Document Server

This paper explores an approach to Bayesian sample size determination in clinical trials. The approach falls into the category of what is often called "proper Bayesian", in that it does not mix frequentist concepts with Bayesian ones. A criterion for a "successful trial" is defined in terms of a posterior probability, its probability is assessed using the marginal distribution of the data, and this probability forms the basis for choosing sample sizes. We illustrate with a standard problem in clinical trials, that of establishing superiority of a new drug over a control.

Muirhead, Robb J

2012-01-01

387

The role of clinical trials in veterinary oncology.  

Science.gov (United States)

Clinical trials for companion animals are becoming more common and more accessible to pet owners as veterinary oncologists seek to expand their knowledge of tumor biology in companion animal species and improve the way they diagnose and treat cancer for these animals. Many owners enroll their pets because they wish to participate in clinical cancer research that may ultimately benefit pets and people. Understanding the goals, benefits, and risks of clinical trials participation provides the knowledge needed by primary care veterinarians to counsel their clients as to whether clinical trial participation is a good choice for them and their pets. PMID:25174911

Burton, Jenna; Khanna, Chand

2014-09-01

388

On the methodology of drug trials in migraine with aura  

DEFF Research Database (Denmark)

INTRODUCTION: Specific problems occur in clinical treatment trials for migraine with aura that differ from those encountered in treatment trials for migraine without aura. DISCUSSION: Based on our experience with four such trials, we point to a number of possible solutions and outline areas for future inquiry. We make recommendations about subject selection; the choice, definition and assessment of outcome measures; optimal treatments in relation to aura and headache; and we provide samples of study report forms used to record occurrence of aura and headache in this population.

Hauge, Anne Werner; Hougaard, Anders

2010-01-01

389

Clinical trials - from anecdotes to evidence based medicine  

Directory of Open Access Journals (Sweden)

Full Text Available Treatments based on theory and anecdote with extravagant public claims without being properly tested has become past time in medical practice. Only valid unbiased and relevant evidence obtained by methodology of clinical trials should be adopted in medical practice and practice guidelines. In such way clinical decisions are based on evidence rather than on authority. Inevitable part of clinical trials is medical ethics formally defined within the Nuremberg Code, World Medical Association Declaration of Helsinki and guidelines issued by the U.S. Department of Health, Education and Welfare. This paper presents in short history of clinical trials and current status worldwide.

Baji? Nada

2003-01-01

390

The STRIPES Trial - Support to Rural India's Public Education System  

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Full Text Available Abstract Background Performance of primary school students in India lags far below government expectations, and major disparity exists between rural and urban areas. The Naandi Foundation has designed and implemented a programme using community members to deliver after-school academic support for children in over 1,100 schools in five Indian states. Assessments to date suggest that it might have a substantial effect. This trial aims to evaluate the impact of this programme in villages of rural Andhra Pradesh and will compare test scores for children in three arms: a control and two intervention arms. In both intervention arms additional after-school instruction and learning materials will be offered to all eligible children and in one arm girls will also receive an additional 'kit' with a uniform and clothes. Methods/Design The trial is a cluster-randomised controlled trial conducted in conjunction with the CHAMPION trial. In the CHAMPION trial 464 villages were randomised so that half receive health interventions aiming to reduce neonatal mortality. STRIPES will be introduced in those CHAMPION villages which have a public primary school attended by at least 15 students at the time of a baseline test in 2008. 214 villages of the 464 were found to fulfil above criteria, 107 belonging to the control and 107 to the intervention arm of the CHAMPION trial. These latter 107 villages will serve as control villages in the STRIPES trial. A further randomisation will be carried out within the 107 STRIPES intervention villages allocating half to receive an additional kit for girls on the top of the instruction and learning materials. The primary outcome of the trial is a composite maths and language test score. Discussion The study is designed to measure (i whether the educational intervention affects the exam score of children compared to the control arm, (ii if the exam scores of girls who receive the additional kit are different from those of girls living in the other STRIPES intervention arm. One of the goals of the STRIPES trial is to provide benefit to the controls of the CHAMPION trial. We will also conduct a cost-benefit analysis in which we calculate the programme cost for 0.1 standard deviation improvement for both intervention arms. Trial Registration Current controlled trials ISRCTN69951502

Elbourne Diana

2010-02-01

391

Randomized Controlled Trial on the Effects of Tualang Honey and Hormonal Replacement Therapy (HRT on Cardiovascular Risk Factors, Hormonal Profiles and Bone Density Among Postmenopausal Women: A Pilot Study  

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Full Text Available Results of recent trial have shown some negative effects of HRT on postmenopausal women. Therefore, there has been a need to search for an alternative treatment and honey is one of the well known traditional remedies used in minimizing postmenopausal problems. The objectives of the study were to investigate the effects of Tualang honey on the cardiovascular risk factors, changes in hormonal profiles and also effect on the bone. A randomized controlled trial comparing the effects of Tualang honey 20 g/day and HRT for a 4-month intervention period among healthy postmenopausal Malay women aged 45-60 years old was conducted. The primary outcome measures were changes from baseline on the cardiovascular risk profiles, hormonal profiles and effect on bone. Tualang honey compared with low dose HRT, consumed for 4 months by postmenopausal women had no demonstrable effects on the parameters examined such as blood pressure measurement, body mass index and waist circumference. There was no significant difference in the lipid profile, blood sugar profile and bone density between the two groups at the end of the study period.

Nik Hazlina Nik Hussain

2012-04-01

392

Forecasting Sensorimotor Adaptability from Baseline Inter-Trial Correlations  

Science.gov (United States)

One of the greatest challenges surrounding adaptation to the spaceflight environment is the large variability in symptoms, and corresponding functional impairments, from one crewmember to the next. This renders preflight training and countermeasure development difficult, as a "one-size-fits-all" approach is inappropriate. Therefore, it would be highly advantageous to know ahead of time which crewmembers might have more difficulty adjusting to the novel g-levels inherent to spaceflight. Such knowledge could guide individually customized countermeasures, which would enable more efficient use of crew time, both preflight and inflight, and provide better outcomes. The primary goal of this project is to look for a baseline performance metric that can forecast sensorimotor adaptability without exposure to an adaptive stimulus. We propose a novel hypothesis that considers baseline inter-trial correlations, the trial-to-trial fluctuations in motor performance, as a predictor of individual sensorimotor adaptive capabilities. To-date, a strong relationship has been found between baseline inter-trial correlations and adaptability in two oculomotor systems. For this project, we will explore an analogous predictive mechanism in the locomotion system. METHODS: Baseline Inter-trial Correlations: Inter-trial correlations specify the relationships among repeated trials of a given task that transpire as a consequence of correcting for previous performance errors over multiple timescales. We can quantify the strength of inter-trial correlations by measuring the decay of the autocorrelation function (ACF), which describes how rapidly information from past trials is "forgotten." Processes whose ACFs decay more slowly exhibit longer-term inter-trial correlations (longer memory processes), while processes whose ACFs decay more rapidly exhibit shorterterm inter-trial correlations (shorter memory processes). Longer-term correlations reflect low-frequency activity, which is more easily measured in the frequency domain. Therefore, we use the power spectrum (PS), which is the Fourier transform of the ACF, to describe our inter-trial correlations. The decay of the PS yields a straight line on a log-log frequency plot, which we quantify by Beta = - (slope of PS on log-log axes). Hence, Beta is a measure of the strength of inter- trial correlations in the baseline data. Larger Beta values are indicative of longer inter-trial correlations. Experimental Approach: We will begin by performing a retrospective analysis of treadmill-gait adaptation data previously collected by Dr. Bloomberg and colleagues. Specifically, we will quantify the strength of inter-trial correlations in the baseline step cadence and heart rate data and compare it to the locomotor adaptability performance results already described by these investigators. Incorporating these datasets will also allow us to explore the applicability of (and potential limitations surrounding) the use of Beta in forecasting physiological performance. We will also perform a new experiment, in which Beta will be derived from baseline data collected during over-ground (non-treadmill) walking, which will enable us to consider locomotor performance, through the parameter Beta, under the most functionallyrelevant, natural gait condition. This experiment will incorporate two baseline and five post-training over-ground locomotion tests to explore the consistency and potential adaptability of the Beta values themselves. HYPOTHESES: We hypothesize that the strength of baseline inter-trial correlations of step cadence and heart rate will relate to locomotor adaptability. Specifically, we anticipate that individuals who show weaker longer-term inter-trial correlations in baseline step cadence data will be the better adaptors, as step cadence can be modified in real-time (i.e., online corrections are an inherent property of the locomotor system; analogous to results observed in the VOR). Conversely, because heart rate is not altered mid-beat, we expect that individuals who demonstrate stronger lon

Beaton, K. H.; Bloomberg, J. J.

2014-01-01

393

All metal PCP field trial update  

Energy Technology Data Exchange (ETDEWEB)

This paper described a new technology designed to assist in steam assisted gravity drainage (SAGD) and cyclic steam stimulation (CSS) processes. Based on a standard progressing cavity pump (PCP), the PCM Vulcain used a completely metallic pump to push temperatures to 350 degrees C. The design also included a high temperature seal. The all-metal PCP was constructed of 3 hydro-formed stator tubes with flanges connected to an outer housing. This paper provided completion configurations for both downhole and surface equipment as well as results of field trials conducted to evaluate the new technology. It was concluded that the tests have demonstrated that the process is more cost effective and provides better quality control than standard PCPs. Tests have also confirmed its hydraulic performance, differential pressures, and its ability to operate optimally with a wide range of viscosities. Outlines of case studies and modelling studies conducted to optimize the pump's performance were included. 2 refs., 1 tab., 6 figs.

Damnjanovic, A.; Jahn, S.; Mitskopoulos, G.; Seince, L. [Kudu Industries PCM, Calgary, AB (Canada)

2008-07-01

394

Analyzing Incomplete Discrete Longitudinal Clinical Trial Data  

CERN Document Server

Commonly used methods to analyze incomplete longitudinal clinical trial data include complete case analysis (CC) and last observation carried forward (LOCF). However, such methods rest on strong assumptions, including missing completely at random (MCAR) for CC and unchanging profile after dropout for LOCF. Such assumptions are too strong to generally hold. Over the last decades, a number of full longitudinal data analysis methods have become available, such as the linear mixed model for Gaussian outcomes, that are valid under the much weaker missing at random (MAR) assumption. Such a method is useful, even if the scientific question is in terms of a single time point, for example, the last planned measurement occasion, and it is generally consistent with the intention-to-treat principle. The validity of such a method rests on the use of maximum likelihood, under which the missing data mechanism is ignorable as soon as it is MAR. In this paper, we will focus on non-Gaussian outcomes, such as binary, categorica...

Jansen, I; Molenberghs, G; Verbeke, G; Mallinckrodt, C; Jansen, Ivy; Beunckens, Caroline; Molenberghs, Geert; Verbeke, Geert; Mallinckrodt, Craig

2006-01-01

395

Interpretation of Subgroup Effects in Published Trials  

DEFF Research Database (Denmark)

With the rapidly expanding number of studies reporting on treatment subgroups come new challenges in analyzing and interpreting this sometimes complex area of the literature. This article discusses 3 important issues regarding the analysis and interpretation of existing trials or systematic reviews that report on treatment effect modifiers (subgroups) for specific physical therapy interventions. The key messages are: (1) point estimates of treatment modifier effect size (interaction effect) and their confidence intervals can be calculated using group-level data when individual patient-level data are not available; (2) interaction effects do not define the total effect size of the intervention in the subgroup but rather how much more effective it is in the subgroup than in those not in the subgroup; (3) recommendations regarding the use of an intervention in a subgroup need to consider the size and direction of the main effect and the interaction effect; and (4) rather than simply judging whether a treatment modifier effect is clinically important based only on the interaction effect size, a better criterion is to determine whether the combined effect of the interaction effect and main effect makes the difference between an overall effect that is clinically important and one that is not clinically important.

Hancock, Mark J; Kjær, Per

2013-01-01

396

Decision-Making Trial and Evaluation Laboratory  

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

Elham Falatoonitoosi

2013-04-01

397

Imaging in early phase childhood cancer trials  

Energy Technology Data Exchange (ETDEWEB)

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

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

2009-02-15

398

The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations.  

Science.gov (United States)

Pharmaceutical companies increasingly perform clinical trials in developing nations. Governments of host nations see the trials as a way to provide otherwise unaffordable medical care, while trial sponsors are drawn to those countries by lower costs, the prevalence of diseases rare in developed nations, and large numbers of impoverished patients. Local governments, however, fail to police trials, and the FDA does not monitor trials in foreign countries, resulting in the routine violation of international standards for the protection of human subjects. This Note proposes independent accreditation of those institutions involved in clinical trials--the institutional review boards which oversee trial protocol; the organizations, such as pharmaceutical companies, which sponsor the trials; and the research organizations that conduct the trials. Accreditation, similar to that used in the footwear and apparel industries, would increase the transparency of pharmaceutical trials and would enable the United States government and consumers to hold trial sponsors accountable for their actions. PMID:16755695

Kelleher, Finnuala

2004-01-01

399

A randomised clinical trial of a comprehensive exercise program for chronic whiplash: trial protocol  

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Full Text Available Abstract Background Whiplash is the most common injury following a motor vehicle accident. Approximately 60% of people suffer persistent pain and disability six months post injury. Two forms of exercise; specific motor relearning exercises and graded activity, have been found to be effective treatments for this condition. Although the effect sizes for these exercise programs, individually, are modest, pilot data suggest much larger effects on pain and disability are achieved when these two treatments are combined. The aim of this study is to investigate the effectiveness and cost-effectiveness of this comprehensive exercise approach for chronic whiplash. Methods/Design A multicentre randomised controlled trial will be conducted. One hundred and seventy-six participants with chronic grade I to II whiplash will be recruited in Sydney and Brisbane, Australia. All participants will receive an educational booklet on whiplash and in addition, those randomised to the comprehensive exercise group (specific motor relearning and graded activity exercises will receive 20 progressive and individually-tailored, 1 hour exercise sessions over a 12 week period (specific motor relearning exercises: 8 sessions over 4 weeks; graded activity: 12 sessions over 8 weeks. The primary outcome to be assessed is pain intensity. Other outcomes of interest include disability, health-related quality of life and health service utilisation. Outcomes will be measured at baseline, 14 weeks, 6 months and 12 months by an assessor who is blinded to the group allocation of the subjects. Recruitment is due to commence in late 2009. Discussion The successful completion of this trial will provide evidence on the effectiveness and cost-effectiveness of a simple treatment for the management of chronic whiplash. Trial registration ACTRN12609000825257

Latimer Jane

2009-12-01

400

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

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

Ball T Blake

2009-09-01

401

Intrathecal baclofen treatment in dystonic cerebral palsy: a randomized clinical trial: the IDYS trial  

Science.gov (United States)

Background Dystonic cerebral palsy is primarily caused by damage to the basal ganglia and central cortex. The daily care of these patients can be difficult due to dystonic movements. Intrathecal baclofen treatment is a potential treatment option for dystonia and has become common practice. Despite this widespread adoption, high quality evidence on the effects of intrathecal baclofen treatment on daily activities is lacking and prospective data are needed to judge the usefulness and indications for dystonic cerebral palsy. The primary aim of this study is to provide level one clinical evidence for the effects of intrathecal baclofen treatment on the level of activities and participation in dystonic cerebral palsy patients. Furthermore, we hope to identify clinical characteristics that will predict a beneficial effect of intrathecal baclofen in an individual patient. Methods/Design A double blind placebo-controlled multi-center randomized clinical trial will be performed in 30 children with dystonic cerebral palsy. Patients aged between 4 and 25 years old with a confirmed diagnosis of dystonic cerebral palsy, Gross Motor Functioning Classification System level IV or V, with lesions in the cerebral white matter, basal ganglia or central cortex and who are eligible for intrathecal baclofen treatment will be included. Group A will receive three months of continuous intrathecal baclofen treatment and group B will receive three months of placebo treatment, both via an implanted pump. After this three month period, all patients will receive intrathecal baclofen treatment, with a follow-up after nine months. The primary outcome measurement will be the effect on activities of and participation in daily life measured by Goal Attainment Scaling. Secondary outcome measurements on the level of body functions include dystonia, spasticity, pain, comfort and sleep-related breathing disorders. Side effects will be monitored and we will study whether patient characteristics influence outcome. Discussion The results of this study will provide data for evidence-based use of intrathecal baclofen in dystonic cerebral palsy. Trial registration Nederlands Trial Register, NTR3642 PMID:24165282

2013-01-01

402

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

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

Margrain Tom H

2012-07-01

403

Prevention trial in the Cherokee Nation: design of a randomized community trial.  

Science.gov (United States)

Despite advances in prevention science and practice in recent decades, the U.S. continues to struggle with significant alcohol-related risks and consequences among youth, especially among vulnerable rural and Native American youth. The Prevention Trial in the Cherokee Nation is a partnership between prevention scientists and Cherokee Nation Behavioral Health to create, implement, and evaluate a new, integrated community-level intervention designed to prevent underage drinking and associated negative consequences among Native American and other youth living in rural high-risk underserved communities. The intervention builds directly on results of multiple previous trials of two conceptually distinct approaches. The first is an updated version of CMCA, an established community environmental change intervention, and the second is CONNECT, our newly developed population-wide intervention based on screening, brief intervention, and referral to treatment (SBIRT) research. CMCA direct-action community organizing is used to engage local citizens to address community norms and practices related to alcohol use and commercial and social access to alcohol among adolescents. The new CONNECT intervention expands traditional SBIRT to be implemented universally within schools. Six key research design elements optimize causal inference and experimental evaluation of intervention effects, including a controlled interrupted time-series design, purposive selection of towns, random assignment to study condition, nested cohorts as well as repeated cross-sectional observations, a factorial design crossing two conceptually distinct interventions, and multiple comparison groups. The purpose of this paper is to describe the strong partnership between prevention scientists and behavioral health leaders within the Cherokee Nation, and the intervention and research design of this new community trial. PMID:24615546

Komro, Kelli A; Wagenaar, Alexander C; Boyd, Misty; Boyd, B J; Kominsky, Terrence; Pettigrew, Dallas; Tobler, Amy L; Lynne-Landsman, Sarah D; Livingston, Melvin D; Livingston, Bethany; Molina, Mildred M Maldonado

2015-02-01

404

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

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

Schlitt Hans

2010-04-01

405

The Metabolic and Endocrine Response and Health Implications of Consuming Sugar-Sweetened Beverages: Findings From Recent Randomized Controlled Trials123  

Science.gov (United States)

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

Rippe, James M.

2013-01-01

406

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

DEFF Research Database (Denmark)

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

Danielsen, Anne Kjaergaard; Correa-Marinez, Adiela

2011-01-01

407

A pragmatic cluster randomised controlled trial of a Diabetes REcall And Management system: the DREAM trial  

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Full Text Available Abstract Background Following the introduction of a computerised diabetes register in part of the northeast of England, care initially improved but then plateaued. We therefore enhanced the existing diabetes register to address these problems. The aim of the trial was to evaluate the effectiveness and efficiency of an area wide 'extended,' computerised diabetes register incorporating a full structured recall and management system, including individualised patient management prompts to primary care clinicians based on locally-adapted, evidence-based guidelines. Methods The study design was a pragmatic, cluster randomised controlled trial, with the general practice as the unit of randomisation. Set in 58 general practices in three Primary Care Trusts in the northeast of England, the study outcomes were the clinical process and outcome variables held on the diabetes register, patient-reported outcomes, and service and patient costs. The effect of the intervention was estimated using generalised linear models with an appropriate error structure. To allow for the clustering of patients within practices, population averaged models were estimated using generalized estimating equations. Results Patients in intervention practices were more likely to have at least one diabetes appointment recorded (OR 2.00, 95% CI 1.02, 3.91, to have a recording of a foot check (OR 1.87, 95% CI 1.09, 3.21, have a recording of receiving dietary advice (OR 2.77, 95% CI 1.22, 6.29, and have a recording of blood pressure (BP (OR 2.14, 95% CI 1.06, 4.36. There was no difference in mean HbA1c or BP levels, but the mean cholesterol level in patients from intervention practices was significantly lower (-0.15 mmol/l, 95% CI -0.25, -0.06. There were no differences in patient-reported outcomes or in patient-reported use of drugs, or uptake of health services. The average cost per patient was not significantly different between the intervention and control groups. Costs incurred in administering the system at the register and in general practice were in addition to these. Conclusion This study has shown benefits from an area-wide, computerised diabetes register incorporating a full structured recall and individualised patient management system. However, these benefits were achieved at a cost. In future, these costs may fall as electronic data exchange becomes a reliable reality. Trial registration: International Standard Randomised Controlled Trial Number (ISRCTN Register, ISRCTN32042030.

Grimshaw Jeremy M

2007-02-01

408

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

Directory of Open Access Journals (Sweden)

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

Alvaro Silva G.

2010-09-01

409

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

410

Processes for Quality Improvements in Radiation Oncology Clinical Trials  

International Nuclear Information System (INIS)

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

411

Outcomes and endpoints in cancer trials: bridging the divide.  

Science.gov (United States)

Cancer is not one disease. Outcomes and endpoints in trials should incorporate the therapeutic modality and cancer type because these factors affect clinician and patient expectations. In this Review, we discuss how to: define the importance of endpoints; make endpoints understandable to patients; improve the use of patient-reported outcomes; advance endpoints to parallel changes in trial design and therapeutic interventions; and integrate these improvements into trials and practice. Endpoints need to reflect benefit to patients, and show that changes in tumour size either in absolute terms (response and progression) or relative to control (progression) are clinically relevant. Improvements in trial design should be accompanied by improvements in available endpoints. Stakeholders need to come together to determine the best approach for research that ensures accountability and optimises the use of available resources. PMID:25638556

Wilson, Michelle K; Collyar, Deborah; Chingos, Diana T; Friedlander, Michael; Ho, Tony W; Karakasis, Katherine; Kaye, Stan; Parmar, Mahesh K B; Sydes, Matthew R; Tannock, Ian F; Oza, Amit M

2015-01-01

412

Smoking Cessation Drug Proves Effective in Single-Center Trial  

Science.gov (United States)

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

413

Ethical considerations concerning treatment allocation in drug development trials.  

Science.gov (United States)

It is claimed that much of the opposition to placebos is based on the misunderstanding that their use implies the withholding of effective treatments. It is also argued that the ethical feasibility of a trial must be judged by comparing the likely prognosis of patients in the trial to their expectations outside the trial. Furthermore, a longer-term perspective of the patients needs is necessary; the ethical dilemmas involved cannot be resolved at the point of sickness. Some device such as the 'original position' of the philosopher John Rawls is needed. Finally, it is argued that placebo run-ins involve a violation of consent and should be eliminated from clinical trials. PMID:12357586

Senn, S

2002-10-01

414

A pilot trial of dextromethorphan in amyotrophic lateral sclerosis.  

Science.gov (United States)

Assuming the presence of glutamate-induced neurotoxicity in amyotrophic lateral sclerosis 14 patients were treated with dextromethorphan, an N-methyl-D-aspartate receptor antagonist. The patients were treated with 150 mg dextromethorphan or placebo daily for 12 weeks in a double-blind crossover trial, with a wash out period of 4 weeks between the two treatment periods. Thereafter the surviving patients were treated with 300 mg dextromethorphan daily for up to 6 months in an open trial. No positive effects on clinical or neurophysiological parameters (relative number of axons, and compound muscle action potentials in the abductor digiti minimi muscle) were observed either in the double-blind trial or in the open trial. PMID:8437010

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

1993-02-01

415

Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial  

DEFF Research Database (Denmark)

To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR.

Kreiner, Frederik; Galbo, Henrik

2010-01-01

416

Phase 0/I/II Cancer Prevention Clinical Trials Program  

Science.gov (United States)

To efficiently design and conduct early phase clinical trials necessary to assess the potential of cancer preventive agents of various classes, many of which are directed at molecular targets which have been shown to be expressed in intraepithelial neoplasia (IEN).

417

Reducing trial length in force platform posturographic sleep deprivation measurements  

Science.gov (United States)

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

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

2007-09-01

418

Wrongful termination: lessons from the geron clinical trial.  

Science.gov (United States)

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

Scott, Christopher Thomas; Magnus, David

2014-12-01

419

Lung Cancer Screening Saves Lives: The National Lung Screening Trial  

Science.gov (United States)

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

420

CliniProteus: A flexible clinical trials information management system  

Science.gov (United States)

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

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

2007-01-01

421

Patients’ preferences for selection of endpoints in cardiovascular clinical trials  

Directory of Open Access Journals (Sweden)

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

Robert D. Chow

2014-02-01

422

Antibiotic prophylaxis in permanent pacemaker implantation: a prospective randomised trial.  

OpenAIRE

BACKGROUND--Pacemaker pocket infection is a potentially serious problem after permanent pacemaker implantation. Antibiotic prophylaxis is commonly prescribed to reduce the incidence of this complication, but current trial evidence of its efficacy is conflicting. A large prospective randomised trial was therefore performed of antibiotic prophylaxis in permanent pacemaker implantation. The intention was firstly to determine whether antibiotic prophylaxis is efficacious in these patients and sec...

Mounsey, J. P.; Griffith, M. J.; Tynan, M.; Gould, F. K.; Macdermott, A. F.; Gold, R. G.; Bexton, R. S.

1994-01-01

423

Black patients receive less clinical trial information than white patients  

Science.gov (United States)

A study from the Wayne State University School of Medicine and the Barbara Ann Karmanos Cancer Institute comparing how physicians discuss clinical trials during clinical interactions with black patients versus white patients further confirms racial disparities in the quality of communication between physicians and patients. Oncologists provided black patients with less information overall about cancer clinical trials compared with white patients, according to data presented at the Fifth AACR Conference on The Science of Cancer Health Disparities, Oct. 27-30, 2012.

424

A review of human and analogue insulin trials.  

OpenAIRE

A recent meta-analysis evaluated trials of the rapid-acting analogues insulin lispro and insulin aspart, performed before the introduction of the basal analogues, insulin glargine and insulin detemir. This article reviews the effect of rapid-acting and basal insulin analogues separately and in combination, relative to human insulin. Outcomes evaluated include HbA(1c), hypoglycaemia, postprandial glucose (PPG), and weight changes. Results from trials that matched defined criteria are presented...

Gough, Sc

2007-01-01

425

Methodological quality and reporting of ethical requirements in clinical trials  

OpenAIRE

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

Ruiz-canela, M.; Irala, J.; Martinez-gonzalez, M. A.; Gomez-gracia, E.; Fernandez-crehuet, J.

2001-01-01

426

Statins in heart failure: do we need another trial?  

OpenAIRE

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

Ko, Bonsu; Kadirvelu A; Dd, Reidpath

2013-01-01

427

Quality evaluation of controlled clinical information service trials.  

OpenAIRE

Randomized controlled clinical trials are increasingly accepted as tools of computer technology assessment and, therefore, quality evaluation of trials has great theoretical and practical significance. The purpose of this study was to assist the design of evaluation studies and synthesis of published results by developing and validating an easy-to-use quality scoring method. The development of the new scoring system was based on the available quality evaluation methods and the analysis of 19 ...

Balas, E. A.; Austin, S. M.; Brown, G. D.; Mitchell, J. A.

1993-01-01

428

How to Calculate Sample Size in Randomized Controlled Trial?  

OpenAIRE

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

Zhong, Baoliang

2009-01-01

429

Difficulties in recruitment for a randomized controlled trial involving hysterosalpingography  

OpenAIRE

Abstract Background The usefulness of hysterosalpingography (HSG) as routine investigation in the fertility work-up prior to laparoscopy and dye had been assessed in a randomized controlled trial. Recruiting subjects to the study was more difficult than anticipated. The objective of this study was to explore possible reasons for non-participation in the trial. Methods All newly referred subfertile women admitted to the Reproductive Medicine Clinic of Leiden University Medical Centre between 1...

Helmerhorst Frans M; Jm, Craen Anton; Am, Perquin Denise

2006-01-01

430

Qigong and Fibromyalgia: Randomized Controlled Trials and Beyond  

OpenAIRE

Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6–8 weeks) produces improvements in core domains for fibromyalgia (p...

Jana Sawynok; Mary Lynch

2014-01-01

431

Unique perception of clinical trials by Korean cancer patients  

Directory of Open Access Journals (Sweden)

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

Lee Su Jin

2012-12-01

432

Reporting Methods of Blinding in Randomized Trials Assessing Nonpharmacological Treatments  

OpenAIRE

BACKGROUND: Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard) methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. METHODS AND FINDINGS: We systematically searched in Medline and the Cochrane Methodology Register for randomized con...