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1

Reconstruction of models via well-known scale factors  

Science.gov (United States)

We explore the reconstruction scheme of new holographic dark energy and modified f( R) Horava-Lifshitz gravity in the presence of three well-known scale factors such as the emergent, logamediate and intermediate ones. We analyze the behavior of reconstructed models corresponding to these scale factors. We also present the analysis of the equation of state parameter which shows consistency with the present cosmological scenario. The squared speed of sound is also developed in this framework for analyzing the instability of the reconstructed models for all scale factors.

Jawad, Abdul

2014-10-01

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

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

Science.gov (United States)

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

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

2011-07-01

4

Geometric discord and Measurement-induced nonlocality for well known bound entangled states  

Digital Repository Infrastructure Vision for European Research (DRIVER)

We employ geometric discord and measurement induced nonlocality to quantify non classical correlations of some well-known bipartite bound entangled states, namely the two families of Horodecki's ($2\\otimes 4$, $3\\otimes 3$ and $4\\otimes 4$ dimensional) bound entangled states and that of Bennett etal's in $3\\otimes 3$ dimension. In most of the cases our results are analytic and both the measures attain relatively small value. The amount of quantumness in the $4\\otimes 4$ boun...

Rana, Swapan; Parashar, Preeti

2012-01-01

5

Perspectives on craniosynostosis: sutural biology, some well-known syndromes, and some unusual syndromes.  

Science.gov (United States)

Perspectives on craniosynostosis are discussed under the following headings: sutural biology (anatomic and genetic categories of synostosis; sutures, suture systems, and types of craniosynostosis; well-known syndromes (Muenke syndrome and Pfeiffer syndrome); and unusual syndromes (thanatophoric dysplasia, Beare-Stevenson cutis gyrata syndrome, Crouzonodermoskeletal syndrome, Carpenter syndrome, Elejalde syndrome, hypomandibular faciocranial syndrome, and craniorhiny). Five of these syndromes are caused by fibroblast growth factor receptor (FGFR) mutations; one is caused by ras-like in rat brain 23 (RAB23) mutations; and three have Mendelian patterns of inheritance, but the molecular basis remains unknown to date. PMID:19293680

Cohen, M Michael

2009-03-01

6

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

Science.gov (United States)

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

Yuan, Shi-Min; Jing, Hua

2011-01-01

7

Mobile System to Guide Blind People in a Well-Known Environment  

Science.gov (United States)

The system aids to low-vision disabled people to move in a well-known environment, at the University of Almeria. So, a 3G mobile phone has been used in order to help blind people to have a better standard of life because they could go from a building to other using his mobile phone. Therefore, audible instructions are used to inform the user, which will have been decided in advance by the computer vision module (the decision will be taken according to the environment). That module captures images in real time (using the camera of the mobile phone, which has to be over the chest of the user, fixed with a string) and recognizes static objects in the middle of the way. Moreover, it tries to avoid the situation in which the user is going out of the way. On the other hand, an application has been developed so as to supervise all the users of the system and even visualize their position.

Domene, Luis M.; Piedra, José A.; Cantón, Manuel

8

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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 a...

Patki, Pralhad S.; Thippeswamy Agadihiremath; Viswanatha, Gollapalle L.; Anturlikar, Suryakanth D.; Jayaramaiah, Kavya K.; Mohamed Rafiq

2013-01-01

9

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

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

11

Alexander Ya. Orolv - Well-Known Scientist and Recognized Organizer of Astronmoical Research. Little Known Facts of His Life  

Science.gov (United States)

Alexander Ya. Orlov is a well-known astronomer and geophysicist as well as a worldrecognized organizer of scientific research in Russia, the USSR, and Ukraine. Orlov has formulated his main scientific ideas during the Odesa's period of life. He studied a tidal deformation of the Earth and its polar motion using the gravity and latitude observations. He has proposed new defenitions of a mean pole and a mean latitude, as wel as a new method for determing the Earth pole coordinates. To the end of 1940-ties, the Orlov's scientific ideas were implemented and stimulated a development of a research field, which is now called as Astrogeodynamics or Space Geodynamics. Among the representatives of the Orlov's scientific school are about 20 Doctors of Sciences and more than 40 Candidates of Sciences, including the members of Academy of Sciences of Ukraine and other countries. Among them are N.Stoyko-Radilenko (France), J.Witkowski (Poland), V.Zhardetsky (Yugoslavia-Austria-USA), D.Pyaskovsky, Z.Aksent'eva, E.Lavrentieva, N.Popov, E.Fedorov and A.Korol in Ukraine. The deserved followers of the Orlov's scientific ideas were also I.Androsov, I.Dyukov, K.Mansurova, B.Novopashennyj, N.V.Zimmerman in Russia and M.Bursa (Chesh Republic), who worked with him, as well as his sons, A.A.Orlov and B.A. Orlov. The Orlov's life and scientific activity were fully described in many articles. For that reason in this paper we will focus on the little-known facts of the Orlov's scientific-organizational activity, for example, the Orlov's appointments as a director of observatories in Odesa, Poltava, m.Pip-Ivan, Pulkovo, and Kyiv; interesesting facts related to his membership in the Academies of Sciences of the USSR and Ukrainian SSR; organization of a large-scale program on the latitude observations and gravimetric survey. We describe briefly his life and his astrogeodynamic scientific school.

Yatskiv, Ya. S.; Vavilova, I. B.; Korsun', A. A.

12

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

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

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

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  

Digital Repository Infrastructure Vision for European Research (DRIVER)

It is well-known that hypertension is a very common disease, and severe cerebrovascular accidents might occur if the blood pressure is not properly controlled. However, conditions associated with uncontrolled hypertension may be overlooked, and may become critical and eventually require a surgical intervention on an urgent basis. Coronary artery disease, acute aortic syndrome, congenital and valvular heart disease, and arrhythmias are under this topic of discussion. Of them, coronary artery d...

Shi-Min Yuan; Hua Jing

2011-01-01

16

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

Directory of Open Access Journals (Sweden)

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

Yavuz AKBULUT

2007-04-01

17

Transcripts of soybean isoflavone 7-O-glucosyltransferase and hydroxyisoflavanone dehydratase gene homologues are at least as abundant as transcripts of their well known counterparts.  

Science.gov (United States)

The enzymes of the isoflavonoid pathway produce isoflavones, which have multiple functions in defence and symbiosis. Recently, we identified known and novel homologues of several of these enzymes in the soybean genome sequence. In the present study, we have investigated the transcript levels of the isoflavone 7-O-glucosyltransferase (GmIF7GT) and 2-hydroxyisoflavanone dehydratase (HIDH) gene homologues in soybean seedling organs (shoot tips, unifoliate leaves, unifoliate nodes, epicotyls, cotyledons, cotyledonary nodes, hypocotyls and roots) as well as flowers, seeds and whole pods using real-time reverse-transcription polymerase chain reaction (real-time RT-PCR). In addition, the transcript levels were also measured in three cell layers of the soybean pod (exocarp, mesocarp and endocarp) dissected using laser capture microdissection (LCM) at two different developmental stages. Statistical analysis has shown that the transcript level of a less known gene homologue of isoflavone 7-O-glucosyltransferase (GmIF7GT4) is significantly higher (about 11-fold) in the roots than the well known gene homologue (GmIF7GT1) and the other less known homologues. It was also shown that the transcript levels of the less known gene homologue of 2-hydroxyisoflavanone dehydratase (HIDH2) do not differ from those of the well known homologue (HIDH1). PMID:21741851

Livingstone, Julie M; Zolotarov, Yevgen; Strömvik, Martina V

2011-09-01

18

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

Directory of Open Access Journals (Sweden)

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

Naess Eva E

2007-02-01

19

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 SciELO Brazil | Language: English Abstract in portuguese 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

20

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

Directory of Open Access Journals (Sweden)

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

Shi-Min Yuan

2011-06-01

 
 
 
 
21

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

Energy Technology Data Exchange (ETDEWEB)

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

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

2010-05-15

22

A Well-Known But Still Surprising Generator  

Science.gov (United States)

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

Haugland, Ole Anton

2014-12-01

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A Well-Known but Still Surprising Generator  

Science.gov (United States)

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

Haugland, Ole Anton

2014-01-01

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Clinical Trials  

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Full Text Available Clinical Trials Introduction A clinical trial is a research study done to evaluate new treatments in people. Carefully ... a Clinical Trial? A clinical trial is a research study conducted to evaluate new treatments in people. Each ...

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Clinical Trials  

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

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Clinical Trials  

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Full Text Available ... Trials Introduction A clinical trial is a research study done to evaluate new treatments in people. Carefully ... Clinical Trial? A clinical trial is a research study conducted to evaluate new treatments in people. Each ...

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Clinical Trials  

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Full Text Available Clinical Trials Introduction A clinical trial is a research study done to evaluate new treatments in people. ... a Clinical Trial? A clinical trial is a research study conducted to evaluate new treatments in people. ...

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Clinical Trials  

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Full Text Available ... Informed Consent Informed consent is a process of learning key facts about a clinical trial before deciding ... As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical ...

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Clinical Trials  

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Full Text Available ... In A Clinical Trial? The ethical and legal codes that govern medical practice apply to clinical trials. ... at http://clinicaltrials.gov ClinicalTrials.gov provides patients, families, and members of the public easy access to ...

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Clinical Trials  

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

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Clinical Trials  

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

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Clinical Trials  

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

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Clinical Trials  

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Full Text Available ... Trial? The ethical and legal codes that govern medical practice apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to ...

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Clinical Trials  

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Full Text Available ... help answer some of the most common questions. What is a Clinical Trial? A clinical trial is ... doctors or other members of the research team. What Protection Do You Have As A Participant In ...

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

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

2008-01-01

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

Scientific Electronic Library Online (English)

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

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

2011-07-01

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Clinical Trials  

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Full Text Available ... Any well-run clinical trial is reviewed for patient safety and scientific merit by the research institution. Every ... should provide for monitoring the data and the safety of patients on an ongoing basis. As a clinical trial ...

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Clinical Trials  

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Full Text Available ... doctor or healthcare professional or a Any well-run clinical trial is reviewed for patient safety and ... material, it may become out of date over time. It is important that you rely on the ...

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Clinical Trials  

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Full Text Available ... ask your doctors or other members of the research team. What Protection Do You Have As A Participant In A Clinical Trial? The ethical and legal codes that govern medical practice apply to clinical ...

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Clinical Trials  

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Full Text Available ... Informed Consent Informed consent is a process of learning key facts about a clinical trial before deciding ... the fastest way to find new treatments that work in people. You may be interested in or ...

 
 
 
 
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Clinical Trials  

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Full Text Available ... be sure to ask your doctors or other members of the research team. What Protection Do You ... clinicaltrials.gov ClinicalTrials.gov provides patients, families, and members of the public easy access to information about ...

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Clinical Trials  

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Full Text Available ... information about the location of clinical trials, their design and purpose, criteria for participation and links to ... for your specific condition. ©1995-2012, The Patient Education Institute, Inc. www.X-Plain.com hc010104 Last ...

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Clinical Trials  

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Full Text Available ... and nurses involved in the trial explain the details of the study. Then you are given an ... merit by the research institution. Every study should provide for monitoring the data and the safety of ...

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Clinical Trials  

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Full Text Available ... for patient safety and scientific merit by the research institution. Every study should provide for monitoring the data and the safety of patients on an ongoing basis. As a clinical trial ...

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Clinical Trials  

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Full Text Available ... Sometimes, no standard treatment yet exists. In drug studies of such cases, one group might receive a new drug and the control group, none. But no one is placed in a control group without ... better than the others in a study, the trial is stopped and the participants in ...

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Bernoulli Trials  

Science.gov (United States)

This online, interactive lesson on Bernoulli provides examples, exercises, and applets. The site, created by Kyle Siegrist of the University of Alabama - Huntsville, covers binomial, geometric, negative binomial, and multinomial distributions. This page is a part of a much larger virtual laboratory on mathematics. It provides a great overview of Bernoulli trials, but also links users to additional lessons on mathematics.

Siegrist, Kyle

47

Clinical Trials  

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Full Text Available ... for your specific condition. ©1995-2012, The Patient Education Institute, Inc. www.X-Plain.com hc010104 Last reviewed: 09/15/2012 1 Why Should You Be Interested in a Clinical Trial? People volunteer to ...

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A class of non-contractive, trial-dependent update rules for Iterative Learning Control  

Digital Repository Infrastructure Vision for European Research (DRIVER)

In this paper, a family of trial-dependent update laws is studied and contrasted with a class of fixed update laws. In particular, it is investigated whether the principle of equivalent feedback extends to trial-dependent update laws. It turns out that this is not the case. Nonetheless, it is shown that a well-known performance bound arising in feedback control architectures, Bode's sensitivity integral, also applies here

Verwoerd, M. H. A.; Meinsma, G.; Vries, T. J. A.

2004-01-01

49

Search for Clinical Trials  

Science.gov (United States)

$data$data Search for Clinical Trials Clinical Trial Questions?Get Help:1-800-4-CANCERLiveHelp online chat Popular Resources Help Using the NCI Clinical Trials Search Form How to Find a Cancer Treatment Trial: A 10-Step Guide Learn About Clinical Trials About

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Participating in Clinical Trials  

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

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Participating in Clinical Trials  

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Full Text Available ... occur. These methods, often called screening tests, can include imaging tests that produce pictures of what is ... type of trial. Prevention Trials Click for more information In prevention trials, researchers study ways to reduce ...

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Participating in Clinical Trials  

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Full Text Available ... Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is ... on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who ...

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How to Register Trials  

Science.gov (United States)

The following steps are designed to guide you through the process of registering trials with NCI's Clinical Trials Reporting Program (CTRP). For detailed instructions, see the NCI Clinical Trials Reporting Program Registration Site User's Guide.

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Participating in Clinical Trials  

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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 ...

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Participating in Clinical Trials  

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Full Text Available ... and supportive care trials. Treatment Trials In treatment trials, researchers may gather information about experimental treatments, their risks, and how well they work compare existing therapies to decide which ...

56

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

CERN Document Server

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

Zhao, Li-Chen

2014-01-01

57

Perspectives on craniofacial asymmetry. III. Common and/or well-known causes of asymmetry.  

Science.gov (United States)

Mandibular asymmetry may be caused by infection or trauma. Unilateral facial paralysis has many causes and Bell's palsy, which is idiopathic, is the most common type. Asymmetric muscle involvement is discussed, including the masseter, temporalis, depressor anguli oris, extraocular, and sternocleidomastoid muscles. Tumors that present asymmetrically are also considered, including the juvenile hemangioma, lymphangioma, osteoma, embryonal rhabdomyosarcoma, and Burkitt's lymphoma. Finally, some miscellaneous conditions are discussed, including fibrous dysplasia, mucus retention phenomenon, electrical burns of the mouth, and cancrum oris. PMID:7608575

Cohen, M M

1995-04-01

58

IgG4-Related Hashimoto's Thyroiditis - A New Variant of a Well Known Disease  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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...

Vara Luiz, H.; Gonc?alves, D.; Nunes Da Silva, T.; Nascimento, I.; Ribeiro, A.; Mafra, M.; Manita, I.; Portugal, J.

2014-01-01

59

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

Scientific Electronic Library Online (English)

Full Text Available SciELO Costa Rica | Language: English Abstract in english 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

60

On-line p,T calibration based on well-known phase transitions  

Science.gov (United States)

The fluid encapsulation technique allows for simultaneous in situ pressure and temperature calibration, at present up to 6 GPa and 800 °C, using on-line data processing. Each experimental run is done quasi-isobarically with continuous variation of temperature. Temperature is determined by the thermal emf's of S- or K-type thermocouples placed in contact with accepted standard calibration materials which undergo pressure and temperature dependent phase transitions. In the course of this study, the phase diagrams of Bi, Hg, Sn, Tl, Pb, and Fe have been reinvestigated and self-consistency between transitions of all of these materials was used to determine the p,T(emf) coordinations. Thermal emf's, for the S-type thermocouple, are converted to temperature using a 20-degree polynomial that fits the IPTS-68 data to within 0.4 K and is continuously differentiable in the temperature range from 0 to 1705 °C.

Secco, R. A.; Schloessin, H. H.

1986-09-01

 
 
 
 
61

The well-known unknown photographer Jaan Klõšeiko / Ellu Maar  

Index Scriptorium Estoniae

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

Maar, Ellu, 1982-

2010-01-01

62

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

63

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

Directory of Open Access Journals (Sweden)

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

Haider Al Kim

2014-11-01

64

Cost Estimation: A Survey of Well-known Historic Cost Estimation Techniques  

Directory of Open Access Journals (Sweden)

Full Text Available Number of contributors has made their efforts to produce different modeling techniques in last four decades. This paper is about the comprehensive descriptive exploration of the models that were presented in the early stages of the software estimation field and covers most of the famous available and practiced parametric models and few non-parametric techniques. All widespread models discussed at one place will give our readers a prospect to comprehend the pros and cons, similarities and the differences among these models

Syed Ali Abbas

2012-04-01

65

Thermodynamic Properties of Rock-Forming Garnets: How Well Known are They?  

Science.gov (United States)

Garnet is an important rock-forming mineral whose geological occurrence is widespread. The silicate garnets (E3G2Si3O12) show extensive compositional variability and the various end-members are stable over an enormous range of rock compositions and pressure and temperature conditions. Extensive geothermometry and geobarometry studies involving garnet have been made. Thus, much research has been done to determine garnet's thermodynamic properties. There are now several internally consistent mineralogical thermodynamic databases and their use is widespread. It is common belief in some/many circles that the present databases represent "the final word" on thermodynamic properties at least in terms of most end-member silicates. The question arises - How true is this assumption in the case of garnet? We have been and are presently engaged in investigating the thermodynamic properties of garnet, where volumetric properties and heat-capacity behavior play a central role. The volumes of the various end-member garnets are now known precisely. Only secondary effects arising from extra minor components (e.g., OH-,Fe3+,Mn3+) have yet to be worked out exactly. In terms of heat capacity Cp behavior, new calorimetric data allow improved understanding. Low T calorimetric measurements on spessartine were made recently and show that previous estimates for S° were in error (Dachs et al. 2009). New unpublished calorimetric results on grossular appear to have resolved long-standing uncertainty regarding its precise S° value. S° for silica-free hydrogrossular has also been determined for the first time. Cp measurements are now focusing on almandine and here low T electronic and magnetic properties must be considered. One can conclude that Cp, S°, ?H°f, V and ?G°f for the common silicate garnet end-members are now well determined to about 1000 K. Cp behavior above roughly 1000 K is less certain for some garnets (e.g., almandine, spessartine). What about thermodynamic behavior of garnet solid solutions? Here, there is much less is known (Geiger 1999). The precise mixing behavior of most garnet binaries, for example, is not understood. An exception is the pyrope-grossular binary, which has now been investigated numerous times and some consensus on its mixing properties now exist. In a related area, crystal-chemical investigations are providing good insight on possible macroscopic thermodynamic mixing behavior. Here, for example, low temperature synchrotron measurements on line broadening of powder diffraction lines give the first quantitative lattice-strain determinations on a solid solution (Dapiaggi et al. 20005). The asymmetric nature of the mixing functions ?Hex, ?Sex, and ?Vex can be explained via strain and local Ca/Mg-O bond behavior. Another area needing further investigation is short-range order. 29Si NMR spectroscopic study of synthetic Py-Gr garnets indicates that some short-range Ca-Mg order may be present. Bosenick et al. (1999) estimate that configurational entropy effects of about 2 J/mole.K may result at T > 1000 °C. It remains to be determined, however, what the structural state is at lower temperatures of 600 to 900 °C. The degree of short-range order could be substantial in metamorphic garnet solid solutions.

Geiger, C. A.; Dachs, E.

2011-12-01

66

Trial Watch  

Science.gov (United States)

Lenalidomide is a synthetic derivative of thalidomide currently approved by the US Food and Drug Administration for use in patients affected by multiple myeloma (in combination with dexamethasone) and low or intermediate-1 risk myelodysplastic syndromes that harbor 5q cytogenetic abnormalities. For illustrative purposes, the mechanism of action of lenalidomide can be subdivided into a cancer cell-intrinsic, a stromal, and an immunological component. Indeed, lenalidomide not only exerts direct cell cycle-arresting and pro-apoptotic effects on malignant cells, but also interferes with their physical and functional interaction with the tumor microenvironment and mediates a robust, pleiotropic immunostimulatory activity. In particular, lenalidomide has been shown to stimulate the cytotoxic functions of T lymphocytes and natural killer cells, to limit the immunosuppressive impact of regulatory T cells, and to modulate the secretion of a wide range of cytokines, including tumor necrosis factor ?, interferon ? as well as interleukin (IL)-6, IL-10, and IL-12. Throughout the last decade, the antineoplastic and immunostimulatory potential of lenalidomide has been investigated in patients affected by a wide variety of hematological and solid malignancies. Here, we discuss the results of these studies and review the status of clinical trials currently assessing the safety and efficacy of this potent immunomodulatory drug in oncological indications. PMID:24482747

Semeraro, Michaela; Vacchelli, Erika; Eggermont, Alexander; Galon, Jerome; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

2013-01-01

67

The Diflunisal Trial: study accrual and drug tolerance.  

Science.gov (United States)

Familial amyloidotic polyneuropathy (FAP) is a protein folding disorder that induces neuropathy and cardiomyopathy, leading to death within 7-15 years after onset of clinical disease. In vitro, small ligands binding the thyroid hormone docking site stabilize tetrameric transthyretin, inhibiting amyloid fibril formation. We undertook a randomized, placebo-controlled clinical trial to determine whether diflunisal, a well-known non-steroidal anti-inflammatory drug (NSAID) alters neurologic disease progression in FAP. We enrolled 130 subjects with wide age and FAP mutation representation. To date, few recognized complications of NSAIDs have occurred in the study cohort. Data collection will be completed by November 2012. PMID:22551208

Berk, John L; Suhr, Ole B; Sekijima, Yoshiki; Yamashita, Taro; Heneghan, Michael; Zeldenrust, Steven R; Ando, Yukio; Ikeda, Shu-ichi; Gorevic, Peter; Merlini, Giampaolo; Kelly, Jeffrey W; Skinner, Martha; Bisbee, Alice B; Dyck, Peter J; Obici, Laura

2012-06-01

68

Managing clinical trials  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.

Kenyon Sara

2010-07-01

69

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

When the difference between treatments in a clinical trial is estimated by a difference in means, then it is well known that randomization ensures unbiassed estimation, even if no account is taken of important baseline covariates. However, when the treatment effect is assessed by other summaries, e.g. by an odds ratio if the outcome is binary, then bias can arise if some covariates are omitted, regardless of the use of randomization for treatment allocation or the size of th...

Matthews, J. N. S.; Badi, Nuri H.

2014-01-01

70

Participating in Clinical Trials  

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Full Text Available ... condition. These trials also continue to study safety, including short-term side effects. This phase can last several years. A Phase III trial gathers more information about safety and effectiveness, studying different populations and ...

71

Participating in Clinical Trials  

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Full Text Available ... clinical trial is to find out if an experimental drug, therapy, medical device, lifestyle change, or test ... prevent a disease. A clinical trial may compare experimental products or tests to those already available or ...

72

Participating in Clinical Trials  

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Full Text Available ... and various types of social interventions. Supportive care interventions are not intended to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described based ...

73

Search NCI Clinical Trials  

Science.gov (United States)

Choose one of the following cancer types to view the clinical trials actively enrolling participants in studies to prevent that type of cancer. All studies are supported by NCI, but not all originate from the Division of Cancer Prevention. Not every cancer type will have active trials at all times. For cancer types not listed here, visit NCI's Clinical Trials information webpage.

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Participating in Clinical Trials  

Medline Plus

Full Text Available ... trial is to find out if an experimental drug, therapy, medical device, lifestyle change, or test will help ... trials to be conducted to determine if the drug can be approved for use. A Phase I trial tests an experimental treatment on a small group of often healthy people ( ...

75

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

76

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

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Thyroid Cancer - Featured Clinical Trials  

Science.gov (United States)

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

78

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

79

Help with Understanding Trial Descriptions  

Science.gov (United States)

This section will help you understand the information that is shown for each trial. Trial descriptions differ based on the source of the trial. Some trials are directly submitted to PDQ and others are imported from the National Library of Medicine's ClincalTrials.gov database. Details about trial descriptions are given below.

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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 ...

 
 
 
 
81

Participating in Clinical Trials  

Medline Plus

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

82

A trial bank model for the publication of clinical trials.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Sim, I.; Rennels, G.

1995-01-01

83

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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 f...

Waldén Markus; Hägglund Martin; Atroshi Isam

2009-01-01

84

Clinical Trials in Vision Research  

Science.gov (United States)

... Programs Training and Jobs Clinical Trials in Vision Research Listen Clinical studies depend on people who volunteer. Download the Clinical Trials in Vision Research Booklet (PDF* - 1.5MB) Download the Clinical Trials ...

85

What Is a Clinical Trial?  

Medline Plus

Full Text Available ... trials to large numbers of patients for the final test phase. The new therapy is compared directly ... clinical trial might be right for them. The medical treatment in clinical trials is given in a ...

86

HIV/AIDS Clinical Trials  

Science.gov (United States)

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

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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  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

88

Update on TROG trials  

International Nuclear Information System (INIS)

Full text: Validation of treatment methodologies can only be achieved in the context of unambiguous, efficiently managed, randomised and controlled clinical trials. Since 1991, the Trans-Tasman Radiation Oncology Group (TROG) has coordinated over 29 protocols in radiation oncology, including several key randomised controlled trials. The impetus behind TROG is the establishment of an evidence base for particular approaches to radiotherapy and its adjunct use with alternative and complementary treatment methods. As the level of technology incorporated into radiotherapy continues to increase, as the need for improved accuracy in dose assessment increases and as the requirements of realistic quality assurance (QA) for clinical trials becomes more demanding it is imperative that all professionals involved in radiotherapy, including physicists, become actively involved in the QA of trials. This is particularly important for large scale multi-centre trials which intend to prove the benefits of particular treatment approaches on a national or international stage rather then in the context of a single clinic. This talk will: 1. Examine the outcomes of TROG trials to date in terms of the information obtained. 2. Briefly consider current and impending TROG trials and their requirements in terms of clinical and physics input. 3. Examine the results of international clinical trials in terms of the influence they have had on radiotherapy practice and health outcomes, and the advantactice and health outcomes, and the advantages they have obtained by consistent co-operation between clinical and technological staff. 4. Consider the benefits of multi-centre clinical trials and the QA controls that are necessary to ensure accuracy of resulting recommendations. Copyright (2001) Australasian College of Physical Scientists and Engineers in Medicine

89

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.

90

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 ...

91

Cancer Clinical Trials  

Science.gov (United States)

... professionals, including other doctors and nurses, laboratory technicians, pharmacists, dietitians, and social workers, to provide medical and ... who have similar characteristics helps ensure that the outcome of a trial is due to the intervention ...

92

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 ...

93

Participating in Clinical Trials  

Medline Plus

Full Text Available ... of caregivers, support groups, and various types of social interventions. Supportive care interventions are not intended to ... These trials also continue to study safety, including short-term side effects. This phase can last several ...

94

Participating in Clinical Trials  

Medline Plus

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

95

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 ...

96

Participating in Clinical Trials  

Medline Plus

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

97

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 ...

98

Predicting Accrual Achievement: Monitoring Accrual Milestones of NCI-CTEP Sponsored Clinical Trials  

Science.gov (United States)

BACKGROUND The need to increase the number oncology clinical trials with sufficient enrollments is a well-known issue particularly for trials targeting therapeutic applications. It is critical to identify early predictors of eventual study accrual achievement. METHODS All non-pediatric, phase I, I/II, II, and III therapeutic studies supported by the National Cancer Institute-Cancer Therapy Evaluation Program between 2000–2007 (n=764) were analyzed for accrual performance. Accrual achievement is defined as those enrolling 100% or more of the stated minimum accrual goal at the time of trial closure. Two accrual milestones were analyzed per trial: time-to-first patient enrollment and expected-time-to-accrual. Multivariate-logistic regression analysis was used to calculate the odds ratio with respect to the likelihood of clinical trial accrual achievement. RESULTS A total of 81.5 percent (n=623) of the trials did not achieve projected accrual goals within the anticipated accruing period. Furthermore, 37.2 percent (n=284) of trials failed to achieve the minimum projected accrual at study closure regardless of time the trial was open. Trials that accrue the first enrollment beyond two months (n=379,49.6%) are significantly less likely to achieve accrual performance than those trials that enroll patients under two months (odds ratio:0. 637,95% CI:0.464–0.875, p=0.005). Of the studies that are open beyond the anticipated enrollment period (n=603), those do not achieve at least 60.0% of the projected minimum accrual (n=391,64.8%) have a significantly less likelihood of achieving final accruals by study closure (odds ratio; 0.190,95% CI:0.055–0.652, p=0.008). CONCLUSIONS The time-to-first-patient enrollment as well as expected-time-to-accrual is shown to be valid measures to evaluate likelihood of achieving minimum projected accrual. PMID:21447723

Cheng, Steven K.; Dietrich, Mary S.; Finnigan, Shanda; Dilts, David M.

2011-01-01

99

[Results from randomized controlled trials: the Hokusai-VTE study].  

Science.gov (United States)

The association of parenteral rapid-onset anticoagulants with oral anticoagulants has become the standard of treatment for venous thromboembolism. Vitamin K antagonists, the most widely used oral anticoagulants, should be administered for at least 3 months or, in some patients, indefinitely. Although this approach is highly effective, it suffers from well known practical limitations. In order to overcome these limitations, a number of studies have assessed the role of novel oral anticoagulant drugs also in this setting. These studies compared standard treatment of venous thromboembolism with the newer compounds that were either administered as a stand alone therapy from the first day or started after an initial course of parenteral therapy. Novel oral anticoagulant drugs have consistently been shown to be as effective as the standard of treatment, and were associated with significantly fewer bleeding events regardless of the study design. The Hokusai-VTE study, the last of these trials to be published, was a randomized controlled trial comparing in more than 8000 patients edoxaban with warfarin in a double blind fashion after an initial course of parenteral treatment with enoxaparin or unfractionated heparin, administered for at least 5 days. We hereby present and discuss the design, the study population, and the results of the Hokusai-VTE trial. PMID:25621573

Ageno, Walter

2014-12-01

100

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

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

2010-01-01

 
 
 
 
101

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

102

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

Science.gov (United States)

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

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

2013-11-01

103

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

104

The Prevailing Obstacles in Web Accessibility on Three Well-Known Websites for Older People with sight difficulties  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Prior research has argued that there is no one best approach to evaluating web accessibility and proposes the adoption of multiple approaches. Following these proposals this research used three different approaches for evaluating accessibility on websites for accessibility to older persons with sight difficulties as there are advantages and disadvantages to each approach. Approached used included: (1) Using automated tools to determine accessibility, which looks at the code of websites to get...

O Reilly, Sarah

2012-01-01

105

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

Directory of Open Access Journals (Sweden)

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

Azize Hassan

2011-12-01

106

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

Scientific Electronic Library Online (English)

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

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

2005-12-01

107

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.)

108

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.

109

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

110

Clinical efficacy and safety of buyang huanwu decoction for acute ischemic stroke: a systematic review and meta-analysis of 19 randomized controlled trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Buyang Huanwu Decoction (BHD) is a well-known traditional Chinese herbal prescription for treating stroke-induced disability. The objective of this study was to evaluate the efficacy and safety of BHD for acute ischemic stroke. A systematic literature search was performed in 6 databases until February 2012. Randomized controlled clinical trials (RCTs) that evaluate efficacy and safety of BHD for acute ischemic stroke were included. Nineteen RCTs with 1580 individuals were identified. The stud...

Chi-zi Hao; Fan Wu; Jiangang Shen; Lin Lu; Deng-lei Fu; Wei-jing Liao; Guo-qing Zheng

2012-01-01

111

Clinical Trial Basics  

Science.gov (United States)

... therapies or procedures in the laboratory and in animal studies, the most promising experimental treatments are moved into ... the researchers carefully examine information collected during the study ... After a phase I or II trial, the researchers decide whether to move on ...

112

Participating in Clinical Trials  

Medline Plus

Full Text Available ... to find out if an 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 ... universities and medical centers across the country. The National Institutes of ...

113

Clinical Trials Guidelines  

Science.gov (United States)

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

114

What Is a Clinical Trial?  

Medline Plus

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

115

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

116

Insurance Coverage and Clinical Trials  

Science.gov (United States)

... your benefits. What are approved clinical trials? Approved clinical trials are research studies that: Test ways to prevent, detect, or treat cancer or other life-threatening diseases Are funded or ...

117

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 ...

118

What Is a Clinical Trial?  

Medline Plus

Full Text Available Announcer: What is a clinical trial? Clinical trials evaluate promising new cancer treatments or methods, from radiation and chemotherapy ... informed consent statement. This statement means you understand what treatments you may receive, possible side effects, your ...

119

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

120

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

Directory of Open Access Journals (Sweden)

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

Freedman Laurence

2010-04-01

 
 
 
 
121

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

122

Holocaust Denial on Trial  

Science.gov (United States)

The past few years have seen a number of demonstration projects arrive on the Internet for use as pedagogical tools in college-level instruction. One such project is the Holocaust Denial on Trial site, developed as part of Emory University's Witness to the Holocaust Program and the Institute for Jewish Studies. Visitors unfamiliar with the case will want to begin with the background section, which outlines the nature of the case, along with answering some basic questions about the participants in the trial. The site contains literally hundreds of primary documents related to the widely discussed British court case in which David Irving (a British Holocaust denier) sued Professor Deborah Lipstadt and her British publisher for libel. The site begins with the complete text of the judgment against Irving, and follows with full-text transcripts spanning from the January 2000 opening statements to closing remarks in March 2000. This site provides an in-depth look into one of the most riveting court trials regarding the nature of Holocaust scholarship (and libel), as well as serving as a well-conceived online educational tool.

123

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

124

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

125

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

126

Gateways to clinical trials.  

Science.gov (United States)

Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 101M, 166Ho-DOTMP, 3-AP; Abatacept, abetimus sodium, ACR-16, adefovir dipivoxil, alefacept, AMD-070, aminolevulinic acid hexyl ester, anatumomab mafenatox, anti-CTLA-4 MAb, antigastrin therapeutic vaccine, AP-12009, AP-23573, APC-8024, aripiprazole, ATL-962, atomoxetine hydrochloride; Bevacizumab, bimatoprost, bortezomib, bosentan, BR-1; Calcipotriol/betamethasone dipropionate, cinacalcet hydrochloride, clofazimine, colchicine, cold-adapted influenza vaccine trivalent, CRM197; Desloratadine, desoxyepothilone B, diethylhomospermine; Edodekin alfa, efalizumab, elcometrine, eletriptan, enfuvirtide, entecavir, EP-2101, eplerenone, erlotinib hydrochloride, etoricoxib, everolimus, exherin, ezetimibe; Febuxostat, fluorescein lisicol, fosamprenavir calcium, frovatriptan; Hemoglobin raffimer, HSPPC-96, human insulin; Imatinib mesylate, insulin detemir, insulin glargine, IRX-2, istradefylline, IV gamma-globulin, ixabepilone; Kahalalide F; L-759274, levodopa/carbidopa/entacapone, licofelone, lonafarnib, lopinavir, lurtotecan, LY-156735; MAb G250, mecasermin, melatonin, midostaurin, muraglitazar; Nesiritide, nitronaproxen; O6-Benzylguanine, olmesartan medoxomil, olmesartan medoxomil/hydrochlorothiazide, omapatrilat, oral insulin; Parecoxib sodium, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ ribavirin, pemetrexed disodium, peptide YY3-36, PG-CPT, phenoxodiol, pimecrolimus, posaconazole; Rasagiline mesilate, rDNA insulin, RG228, rimonabant hydrochloride, rosuvastatin calcium, rotigotine hydrochloride; S-3304, safinamide mesilate, salcaprozic acid sodium salt, SDZ-SID-791, SGN-30, soblidotin, squalamine; Telmisartan/hydrochlorothiazide, testosterone gel, TF(c)-KLH conjugate vaccine, TH-9507, theraloc, tipifarnib, tocilizumab, travoprost; ValboroPro, valdecoxib, veglin, voriconazole; Ximelagatran. PMID:15538546

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

2004-09-01

127

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

128

Gateways to clinical trials.  

Science.gov (United States)

Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables 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

129

Chinese herb trial.  

Science.gov (United States)

St. Luke's-Roosevelt Hospital in New York has opened a phase I/II clinical trial of AZT and TJ-9, a blend of seven medicinal herbs from a traditional oriental medicine known as Xiao Chai Hu Tang. The preparation, also known as Sho-Saiko-To (SSKT), appears to be fairly safe. The study will not measure how well the body absorbs and distributes the herbal blend. Without this data, the results will be harder to interpret because there will be no way of knowing whether the documented laboratory concentrations can be achieved in people. PMID:11363002

1995-12-01

130

Fibrolase: trials and tribulations.  

Science.gov (United States)

Fibrolase is the fibrinolytic enzyme isolated from Agkistrodon contortrix contortrix (southern copperhead snake) venom. The enzyme was purified by a three-step HPLC procedure and was shown to be homogeneous by standard criteria including reverse phase HPLC, molecular sieve chromatography and SDS-PAGE. The purified enzyme is a zinc metalloproteinase containing one mole of zinc. It is composed of 203 amino acids with a blocked amino-terminus due to cyclization of the terminal Gln residue. Fibrolase shares a significant degree of homology with enzymes of the reprolysin sub-family of metalloproteinases including an active site homology of close to 100%; it is rapidly inhibited by chelating agents such as EDTA, and by alpha2-macroglobulin (?2?). The enzyme is a direct-acting thrombolytic agent and does not rely on plasminogen for clot dissolution. Fibrolase rapidly cleaves the A(?)-chain of fibrinogen and the B(?)-chain at a slower rate; it has no activity on the ?-chain. The enzyme exhibits the same specificity with fibrin, cleaving the ?-chain more rapidly than the ?-chain. Fibrolase was shown to have very effective thrombolytic activity in a reoccluding carotid arterial thrombosis model in the canine. A recombinant version of the enzyme was made in yeast by Amgen, Inc. (Thousand Oaks, CA, USA) and called alfimeprase. Alfimeprase is identical to fibrolase except for a two amino acid truncation at the amino-terminus and the insertion of a new amino-terminal amino acid in the truncated protein; these changes lead to a more stable enzyme for prolonged storage. Alfimeprase was taken into clinical trials by Nuvelo, Inc. (San Carlos, CA), which licensed the enzyme from Amgen. Alfimeprase was successful in Phase I and II clinical trials for peripheral arterial occlusion (PAO) and central venous access device (CVAD) occlusion. However, in Phase III trials alfimeprase did not meet the expected end points in either PAO or CVAD occlusion and in a Phaase II stroke trial, and Nuvelo dropped further development in 2008. PMID:22069611

Markland, Francis S; Swenson, Steve

2010-04-01

131

Methodological Challenges in Online Trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Health care and health care services are increasingly being delivered over the Internet. There is a strong argument that interventions delivered online should also be evaluated online to maximize the trial's external validity. Conducting a trial online can help reduce research costs and improve some aspects of internal validity. To date, there are relatively few trials of health interventions that have been conducted entirely online. In this paper we describe the major methodological issues t...

Murray, E.; Khadjesari, Z.; White, I. R.; Kalaitzaki, E.; Godfrey, C.; Mccambridge, J; Thompson, S. G.; Wallace, P.

2009-01-01

132

The International Stroke Trial database  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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...

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

2012-01-01

133

A therapeutic trial of maytansine.  

Science.gov (United States)

A phase II clinical trial of maytansine, a stathmokinetic ansa macrolide, was undertaken in 70 patients. The maximally tolerated dose was 2.0 mg/m2 repeated at 21-day intervals. Gastrointestinal and central neurologic toxicity were dose limiting. No myelosuppression was noted. Two patients demonstrated transient responses. Therapeutic results from four other clinical trials were reviewed. Although additional clinical trials may be warranted in patients with bladder and small cell carcinoma, at the dose schedule reported, maytansine does not appear to possess a broad spectrum of antitumor activity. Additional clinical trials should be limited. PMID:757139

Blum, R H; Wittenberg, B K; Canellos, G P; Mayer, R J; Skarin, A T; Henderson, I C; Parker, L M; Frei, E

1978-01-01

134

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

135

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

136

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: Aciclovir, alemtuzumab, alendronic acid sodium salt, alicaforsen sodium, alteplase, amifostine hydrate, antithymocyte globulin (equine), aspirin, atorvastatin calcium, azathioprine; Bacillus Calmette-Guérin, basiliximab, bicalutamide, bimatoprost, BMS-214662, brimonidine tartrate, buprenorphine hydrochloride; Cabergoline, carbamazepine, carboplatin, ciclosporine, cisplatin, cyclophosphamide; Daclizumab, desmopressin acetate, dihydroergotamine mesylate, dorzolamide hydrochloride, doxorubicin, dutasteride; Everolimus; Fluocinolone acetonide, frovatriptan, FTY-720, fulvestrant; Gabapentin, galantamine hydrobromide, ganciclovir, gemcitabine, glatiramer acetate; Hydrocodone bitartrate; Interferon beta, interferon beta-1a, interferon beta-1b, ipratropium bromide; Ketotifen; Lamivudine, latanoprost, levodopa, lidocaine hydrochloride, lonafarnib; Metformin hydrochloride, methylprednisolone, metoclopramide hydrochloride, mirtazapine, mitoxantrone hydrochloride, modafinil, muromonab-CD3, mycophenolate mofetil; NS-2330; Olopatadine hydrochloride, omalizumab, oxcarbazepine, oxycodone hydrochloride; Paclitaxel, paracetamol, piribedil, pramipexole hydrochloride, pravastatin sodium, prednisone; Quetiapine fumarate; Raloxifene hydrochloride, rituximab, rizatriptan sulfate, Ro-63-8695, ropinirole hydrochloride, rosiglitazone maleate; Simvastatin, siplizumab, sirolimus; Tacrolimus, tegaserod maleate, timolol maleate, tiotropium bromide, tipifarnib, tizanidine hydrochloride, tolterodine tartrate, topiramate, travoprost; Unoprostone isopropyl ester; Valganciclovir hydrochloride, visilizumab; Zidovudine. PMID:12224444

Bayés, M; Rabasseda, X; Prous, J R

2002-01-01

137

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, abarelix, adalimumab, adefovir dipivoxil, AdGVVEGF121.10, anastrozole, anecortave acetate, aripiprazole, asulacrine isethionate, atazanavir, ATL-962, 16-Aza-epothilone B; Bevacizumab, bicalutamide, blonanserin, BMS-188667, bosentan; Celecoxib, celmoleukin, cetuximab, cilomilast, cinacalcet hydrochloride, CNTF(Ax15), colesevelam hydrochloride; Daclizumab, delavirdine mesilate, desogestrel, desoxyepothilone B, dexmethylphenidate hydrochloride, duloxetine hydrochloride; Ecogramostim, emtricitabine, epalrestat, escitalopram oxalate, examorelin, exendin-4, ezetimibe; Fidarestat, frovatriptan; HIV-1 Immunogen; Iloperidone, insulin detemir, insulin lispro, irinotecan hydrochloride; Keratinocyte growth factor; Lasofoxifene tartrate, levetiracetam, levormeloxifene, levosimendan, lumiracoxib, LY-307161 SR; Memantine hydrochloride, MEN-10755, metformin hydrochloride, metreleptin, motexafin gadolinium; Naratriptan hydrochloride, natalizumab, nesiritide, nicotine, NN-2211, NN-414; Olanzapine, omalizumab; Pegaptanib sodium, peginterferon alfa-2a, peginterferon alfa-2b, pegvisomant, pimecrolimus, pirfenidone, pramlintide acetate prasterone, pregabalin; Quetiapine fumarate; Rabeprazole sodium, raloxifene hydrochloride, raltitrexed, rDNA insulin, rFGF-2, risedronate sodium, rofecoxib, roflumilast, rosiglitazone maleate; SN-22995; Tacrolimus, tadalafil, tegaserod maleate, tiotropium bromide, tomoxetine hydrochloride, trastuzumab, trimegestone; Voglibose, Voriconazole; Ziprasidone hydrochloride. PMID:12616707

Bayés, M; Rabasseda, X; Prous, J R

2002-11-01

138

Gateways to clinical trials.  

Science.gov (United States)

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

Tomillero, A; Moral, M A

2008-09-01

139

Defendants' Rights in Criminal Trials.  

Science.gov (United States)

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

Martin, Ralph C., II; Keeley, Elizabeth

1997-01-01

140

Alzheimer's Association TrialMatch  

Science.gov (United States)

... Already have an account? Log in. About Alzheimer's Association TrialMatch ® Alzheimer's Association TrialMatch is a free, easy-to-use clinical ... to create a profile. Step 3 The Alzheimer's Association will compare your unique profile to its comprehensive, ...

 
 
 
 
141

What Is a Clinical Trial?  

Medline Plus

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

142

Electromagnetic Radiation: On Trial  

Science.gov (United States)

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

143

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: Abarelix, ABX-EGF, ademetionine, agomelatine, AMGN-0007, 9-aminocamptothecin, AN-9, anecortave acetate, anidulafungin, AOD-9604, apolizumab, apomate, L-arginine hydrochloride, arzoxifene hydrochloride; Bevacizumab, BP-897, BufferGel; Capravirine, carboxyamidotriazole, carnosine, CC-4047, CEP-701, cerivastatin sodium, clofarabine, conivaptan hydrochloride, CP-461, CS-003; Daptomycin, darifenacin, decitabine, deferasirox, duloxetine hydrochloride; Eberconazole, Ecyd, efalizumab, eglumegad hydrate, EMD-72000, (-)-epigallocatechin gallate, exatecan mesilate, exenatide; Fampridine, fenretinide, ferumoxtran-10; Gadofosveset sodium, garenoxacin mesilate, genistein, glutamine, GPI-15715; Hexyl insulin M2, human insulin, HYB-165; Indisulam, irofulven; KRN-5500, L-796568, laurocapram, lidocaine/prilocaine, lonafarnib, lotrafiban; Melagatran, melatonin, 2-methoxyestradiol, metreleptin, motexafin gadoliniu, motexafin lutetium; Natalizumab, nelarabine, NO-aspirin, NSC-683864; ONO-6126; Pemetrexed disodium, pexelizumab, pirfenidone, PncCRM9, polyglutamate paclitaxel, pramlintide acetate pregabalin, PRO-2000; Ragaglitazar, ramelteon, rasagiline mesilate, rDNA insulin, recombinant glucagon-like peptide-1 (7-36) amide, recombinant human parathyroid hormone (1-84), reolysin RG228, roflumilast, roxifiban acetate, RPI-4610, rubitecan; Safinamide mesilate, solifenacin succinate, SRL-172; T-138067, tafenoquine succinate, tecadenoson, TER-286, tesaglitazar, tetrathiomolybdate, tezosentan disodium, TheraCIM, tigecycline, tipifarnib, tolvaptan, trabectedin, tributyrin, trimegestone, troxacitabine; UCN-01, urokinase alfa; Vinflunine, viscum fraxini 2; Xcellerated T cells, ximelagatran. PMID:14685303

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

2003-11-01

144

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

Science.gov (United States)

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

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

2014-01-01

145

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

146

Bayes' postulate for trinomial trials  

Science.gov (United States)

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

Diniz, M. A.; Polpo, A.

2012-10-01

147

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

148

Sequential boundaries approach in clinical trials with unequal allocation ratios  

Science.gov (United States)

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. PMID:16412232

Jafari, Peyman; Ayatollahi, Seyyed Mohammad Taghi; Behboodian, Javad

2006-01-01

149

HIV/AIDS Clinical Trials  

Science.gov (United States)

... and Alternative Medicine Expanded Access Studies Gene Therapy HIV Therapeutic Vaccines Treatment Adherence Treatment-Experienced Patients Treatment Failure Treatment-Naive Patients Trials by Age Adolescents and Children (birth to 17) Adults (18-65) ...

150

Video on demand internal trial  

Science.gov (United States)

This NYNEX internal trial was designed to test a variety of technical concepts pertaining to a true video on demand system. A three building complex was selected for the trial using coaxial and fiber optic transport systems. The trial period was approximately six weeks long with a total of eighteen movies available twenty four hours a day. A fully automated system was designed at the NYNEX Science and Technology Laboratory that incorporated video equipment and laser disk players. This system is controlled by a pair of Sun Microsystems workstations communicating via a local area network. Valuable knowledge was gained in the area of jukebox design, control systems, and menuing. Fiber optic delivery systems were investigated along with coaxial systems. The user base for this trial consisted of NYNEX employees instead of residential customers. Although the user base was not ideal, we gained insight into how people interact with a fully automated system.

Sell, Chris

1993-02-01

151

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 ...

152

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 ...

153

Medical Coding in Clinical Trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Data generated in all clinical trial are recorded on the data collection instrument Case report Form / Electronic Case Report Form by investigators located at various sites in various countries. In multicentric clinical trials since different investigator or medically qualified experts are from different sites / centers recording the medical term(s) uniformly is a big challenge. Medical coders from clinical data management team process these terms and perform medical coding. Medical coding is...

Babre, Deven

2010-01-01

154

Acupuncture trials and informed consent  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Miller, F. G.; Kaptchuk, T. J.

2007-01-01

155

Blindness in Randomized Controlled Trials  

Directory of Open Access Journals (Sweden)

Full Text Available In combination with randomization, blinding or masking is an important factor inrandomized controlled trials (RCTs, particularly in trials that assess therapeutic effects.Here an attempt is made to explain blindness and why it is important. In clinical trials,blinding is defined as the condition imposed on a study in which study participants,health care providers and assessors collecting outcome data are unaware of the assignedintervention throughout the study. A single-blind trial means that usually one ofthree above mentioned categories of individuals remains unaware of the interventionassignment throughout the trial. The optimal approach, however, is the double-blind trialin which neither the participant nor the health care providers and assessors involved inimplementation of the intervention, evaluation or measurement of outcomes are aware ofthe treatment received. Additionally, nomenclature such as triple-blind or quadruple-blindexist in the literature which offer different and confusing interpretations and definitions.Thus what is very important in reporting the clinical trial is that researchers shouldclearly state those who are blinded and unblinded in their trial rather than solely labelingtheir trial as single-blind, double blind, etc. This issue is quite useful for the reader tojudge the effects of blinding on bias reduction. Knowledge of treatment allocation canaffect patients’ responses since participants who know that they have received a newintervention may report symptoms differently from blinded participants. Another riskof unblinding in the therapeutic trial is unequal cointervention in which patients receivea wide range of other treatments that will, on average, favorably affect their outcomes.This phenomenon may cause confusion in determining whether any outcome differencesare due to the experimental treatment or to unequal cointervention. Furthermore, lack ofblinding can cause ascertainment bias.Ascertainment bias is more important in subjective outcome assessments such aspain scores. Under these circumstances, if individuals are not successfully blinded,psychological responses to intervention could affect the measure of association. The lastrisk of unblinding that should be considered in designing of trials is contamination of thecontrol group. When the clinician or the patient is pretty suspicious that the experimentaltreatment is better than standard treatment one or both of them may take some actionsleading to access of control group to the experimental treatment. This contaminationresults in a decrease in any difference in outcomes between the two groups. Otheressential topics that should be taken into account in the blinding procedure are themethods to maintain blinding of participants and health care providers, assessment ofsuccess of blinding and the difference between blinding and allocation concealment. Wewill consider these topics in future notes (1-2.

Mansour Shamsipour

2010-01-01

156

Phase II Cancer Prevention Clinical Trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Szabo, Eva

2010-01-01

157

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.)

158

A review of international clinical trial registration  

Directory of Open Access Journals (Sweden)

Full Text Available ABSTRACT: Clinical trials play a critical role in medical research. However, only a few clinical trials conducted at present have been registered at various clinical trial registries. Clinical trial registration can prevent bias in these registered trials effectively and avoid unnecessary waste of resources due to meaningless repeats. Moreover, it will benefit the development of evidence-based medicine, and promote human welfare. Great attention has been paid to the importance and necessity of clinical trial registration. This review briefly introduced the definition, justification, contents, history, current status of clinical trial registration, and introduced the information regarding important international clinical trial registries in detail. Clinical trial registration should be developed toward a transparent, compulsory and comprehensive stage

He YU

2007-05-01

159

Clinical trials on AIDS start.  

Science.gov (United States)

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

160

Integrated efficacy to effectiveness trials.  

Science.gov (United States)

Experts in clinical research, therapeutic development, and comparative effectiveness are continually frustrated in their attempts to fit the square peg of therapeutic development into the round hole of clinical trials. Trials can be optimized to provide signals in highly controlled experiments or to estimate an intervention's effect in poorly controlled real-world settings, but not both simultaneously. Selker and colleagues propose a continuum that creates a smooth transition from controlled experiments to real-world, real-time studies within a single mechanism. PMID:24448458

Califf, R M

2014-02-01

 
 
 
 
161

Prototype aircraft development trials with particular reference to tropical trials  

Directory of Open Access Journals (Sweden)

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

S. C. Keshu

2014-05-01

162

The Trials of Presidential Impeachment.  

Science.gov (United States)

Compares the impeachment proceedings in the trials of Andrew Johnson, Richard Nixon, and Bill Clinton. Categorizes an impeachable offense as one that threatens the safety of the country, either as treason or bribery. Asserts that President Clinton did not violate the Constitution and therefore should not have been impeached. (CMK)

Finkelman, Paul

1999-01-01

163

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

164

Prostate Cancer Prevention Trial (PCPT)  

Science.gov (United States)

A fact sheet about the Prostate Cancer Prevention Trial (PCPT), which found that 25 percent fewer men taking the drug finasteride developed prostate cancer than men not taking the drug but that men who developed prostate cancer while taking finasteride were more likely to have high-grade cancers.

165

Trials for malpractice on radiodiagnostics  

International Nuclear Information System (INIS)

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

166

What Is a Clinical Trial?  

Medline Plus

Full Text Available ... effects. A second phase determines the effects of research treatmenton various types of cancer. Once researchers are satisfied that the treatment has potential benefit and acceptable risk, they open clinical trials to large numbers of patients for the final test phase. The new therapy ...

167

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....

168

5 CFR 316.304 - Trial period.  

Science.gov (United States)

...2010-01-01 2010-01-01 false Trial period. 316.304 Section 316.304 Administrative Personnel OFFICE OF PERSONNEL... TEMPORARY AND TERM EMPLOYMENT Term Employment § 316.304 Trial period. (a) The first...

2010-01-01

169

Help With Your Clinical Trial Search Results  

Science.gov (United States)

The number of trials that match your criteria and the number of trials displayed per page are shown. You can also see the search criteria that you entered in the search form or choose to hide the criteria.

170

NCI's Clinical Trials Programs and Initiatives  

Science.gov (United States)

Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives to transform cancer clinical trials to be more flexible and responsive to the rapid advances being made in oncologic sciences.

171

NCI’s National Clinical Trials Enterprise  

Science.gov (United States)

The NCI’s national clinical trials program supports both small early-phase clinical trials and large-scale clinical trials. This program has changed the face of clinical oncology, establishing the safety and efficacy of many therapies now commonly used to treat patients with cancer.

172

Registro dos ensaios clínicos Clinical trials register  

Directory of Open Access Journals (Sweden)

Full Text Available 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 research 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

173

Methodological bias in cluster randomised trials  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Cluster randomised trials can be susceptible to a range of methodological problems. These problems are not commonly recognised by many researchers. In this paper we discuss the issues that can lead to bias in cluster trials. Methods We used a sample of cluster randomised trials from a recent review and from a systematic review of hip protectors. We compared the mean age of participants between intervention groups in a sample of 'good' cluster trials with a sample of potentially biased trials. We also compared the effect sizes, in a funnel plot, between hip protector trials that used individual randomisation compared with those that used cluster randomisation. Results There is a tendency for cluster trials, with evidence methodological biases, to also show an age imbalance between treatment groups. In a funnel plot we show that all cluster trials show a large positive effect of hip protectors whilst individually randomised trials show a range of positive and negative effects, suggesting that cluster trials may be producing a biased estimate of effect. Conclusion Methodological biases in the design and execution of cluster randomised trials is frequent. Some of these biases associated with the use of cluster designs can be avoided through careful attention to the design of cluster trials. Firstly, if possible, individual allocation should be used. Secondly, if cluster allocation is required, then ideally participants should be identified before random allocation of the clusters. Third, if prior identification is not possible, then an independent recruiter should be used to recruit participants.

Torgerson David J

2005-03-01

174

7 CFR 1755.3 - Field trials.  

Science.gov (United States)

...Equipment Contract for Field Trial (Secondary—Delivery...RUS Form 399a, as well as three copies of the RUS...Telecommunications Equipment Field Trial”, and forward them...as the case may be, as well as three copies of the RUS...Telecommunications Field Trial”, and forward...

2010-01-01

175

The Internet and randomised controlled trials.  

Science.gov (United States)

Several factors constrain the implementation of Randomised Controlled Trials (RCTs). To obtain large sample sizes a multicentred multinational trial may be necessary or a long sampling period. The larger the trial the larger is the unit cost. To allow larger sample sizes, shorter sampling periods and lower unit costs, new methods are needed. The Internet and in particular the WWW provides such an opportunity. The WWW can provide global access, fast interaction and automation. A prototype Internet Trials Service (ITS) is currently being tested with a real international clinical trial (the Growth Restriction Intervention Trial--GRIT). The ITS is hosted on a Web server. It provides a series of HTML documents that describe the GRIT protocol. Registered centres may enter patients into the GRIT trial via ITS. Java applets are used to collect trial data before returning the study number and randomisation. ITS assumes all trial data will be intercepted by a sniffer. Therefore no information is sent that could specifically identify a patient, this must be sent later by more secure means. ITS assumes that trial centres can be spoofed. To authenticate the patients entered into the trial and the trial data sent, a regular audit report is sent to each centre by secure means for confirmation. By using Java, a full functional data entry system can be developed that runs locally within any Java enabled browser. It can perform data validation locally and also provide a sophisticated user interface. PMID:9506401

Kelly, M A; Oldham, J

1997-11-01

176

The importance of doing trials right while doing the right trials.  

Science.gov (United States)

Effort is being expended in investigating efficiency measures (i.e., doing trials right) through achievement of accrual and endpoint goals for clinical trials. It is time to assess the impact of such trials on meeting the critical needs of cancer patients by establishing effectiveness measures (i.e., doing the right trials). PMID:22072734

Dilts, David M; Cheng, Steven K

2012-01-01

177

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

178

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

179

Conducting a successful clinical trial  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Hagino, Carol C.

1991-01-01

180

COMPETING COMMITMENTS in CLINICAL TRIALS  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

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

2009-01-01

 
 
 
 
181

A pilot trial in horses  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Traditional diagnostics mainly used Doppler echocardiography for the fast identification of direction, velocity, intensity and characteristic of blood flows. Recent devices offer the possibility of visualising the myocardium regarding direction and velocity of movement using the Doppler principle. In collaboration with human medicine, the present pilot trial compared the velocity profiles of the myocardium determined in horses to those of the human being and of the pig (DERUMEAUX 1998; STR...

Spieker, Eva Patricia

2010-01-01

182

Credentialing for participation in clinical trials  

Directory of Open Access Journals (Sweden)

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

ThomasFitzgerald

2012-12-01

183

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

Directory of Open Access Journals (Sweden)

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

Daly Fergus

2007-03-01

184

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 treatment groups (P = 0.358). No significant adverse effects were reported. In this open study, 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

185

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

Directory of Open Access Journals (Sweden)

Full Text Available 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 of transcription 3 (STAT3, STAT1 and extracellular signal-regulated kinase 1/2 (ERK1/2, but not STAT5. The phosphorylation kinetics of JAK2, STAT3/1 and ERK1/2 induced by Mab263 were subsequently analyzed in dose-response and time course experiments. Our observations indicate that Mab263 induced different intracellular signaling pathways than GH, which indicates that Mab263 is a signal-specific molecule and that Mab263 may be a valuable biological reagent to study the mechanism(s of GHR-mediated intracellular signaling pathways.

Hainan Lan

2014-11-01

186

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

187

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

188

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

189

Well-known Herbig Ae star AB Aur. I. Investigation of variability of the emission lines in the region 0.37-0.88 ?m  

International Nuclear Information System (INIS)

The variability of the profiles, equivalent widths (EW/sub ?/), and relative intensities of of the emission lines in the spectrum of AB Aur has been investigated with a photoelectric scanner. During a 20-day period of observations, EW/sub ?/H/sub ?/ varied from 23.20 to 35.35 /angstrom/. The mean value was EW/sub ?/H/sub ?/ = 27.25 /angstrom/, the rms fluctuation 3.60 +- 0.07 /angstrom/. The shortest variability time was 1 h. The chromospheric lines of the infrared Ca II triplet, K Ca II, the emission lines H?-H13, P12-P20, OI 8446.5 /angstrom/ and others were investigated using spectra obtained photographically or with an image tube. The intensities of these lines vary by factors 2-4 during a time from one hour to several years. The nature of the variability of the emission lines of AB Aur suggests that the deep chromosphere is not a centrally symmetric or axisymmetric formation but rather a conglomerate of gas condensations of different densities and velocities

190

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

Directory of Open Access Journals (Sweden)

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

T. G. Tolstikova

2006-01-01

191

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

192

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

193

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

194

Clinical Trials Explained: A Guide to Clinical Trials in the NHS For Healthcare Professionals  

Digital Repository Infrastructure Vision for European Research (DRIVER)

What will happen during and after a clinical trial? How will a trial affect my quality of life? What are the benefits and risks of a trial? What does giving consent mean and what will it involve? Will I incur costs during and because of the trial? These are the questions that should be raised every time a health care professional talks through with a patient the pros and cons of entering a clinical trial. Clinical Trials Explained has been designed in consultation with doctors and patients wh...

Kerr, Dj; Knox, K.; Robertson, Dc; Stewart, D.; Watson, R.

2007-01-01

195

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

196

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

197

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

198

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

Science.gov (United States)

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

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

2014-10-01

199

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

200

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.

 
 
 
 
201

Innovative clinical trial design for pediatric therapeutics  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

202

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

203

Traversing the Translational Trail for Trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

204

Pharmaceutical clinical trial supply chain management  

Digital Repository Infrastructure Vision for European Research (DRIVER)

New drug development follows an extended sequence of steps (discovery, animal trials, FDA application (IND), product and process development, three phases of clinical trials, FDA filing and approval and launch) as a result of which it takes many years and considerable expense (upwards of $1 Billion) to bring a new drug to market. The clinical trials constitute a critically important and very expensive part of the development process as it involves producing, distributing and administering the...

Chen, Ye

2012-01-01

205

Trials and tribulations in charged particle radiotherapy  

International Nuclear Information System (INIS)

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

206

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.

207

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

208

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

209

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Background Poor recruitment to randomised controlled trials (RCTs) is a widespread and important problem. With poor recruitment being such an important issue with respect to the conduct of randomised trials, a systematic review of controlled trials on recruitment methods was undertaken in order to identify strategies that are effective. Methods We searched the register of trials in Cochrane library from 1996 to end of 2004. We also searched Web of Scien...

Torgerson David J; Watson Judith M

2006-01-01

210

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

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

2008-01-01

211

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

Directory of Open Access Journals (Sweden)

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

Torgerson David J

2006-07-01

212

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

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Randomised controlled trials are the best research design for decisions about the effect of different interventions but randomisation does not, of itself, promote the applicability of a trial's results to situations other than the precise one in which the trial was done. While methodologists and trialists have rightly paid great attention to internal validity, much less has been given to applicability. This narrative review is aimed at those planning to conduct trials, and those aiming to use the information in them. It is intended to help the former group make their trials more widely useful and to help the latter group make more informed decisions about the wider use of existing trials. We review the differences between the design of most randomised trials (which have an explanatory attitude and the design of trials more able to inform decision making (which have a pragmatic attitude and discuss approaches used to assert applicability of trial results. If we want evidence from trials to be used in clinical practice and policy, trialists should make every effort to make their trial widely applicable, which means that more trials should be pragmatic in attitude.

Treweek Shaun

2009-06-01

213

The L'Aquila trial  

Science.gov (United States)

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

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

2013-04-01

214

25 CFR 11.314 - Jury trials.  

Science.gov (United States)

...ORDER COURTS OF INDIAN OFFENSES AND LAW AND ORDER CODE Criminal Procedure § 11.314 Jury trials. (a) A defendant has a right, upon demand, to a jury trial in any criminal case: (1) That is punishable by a maximum sentence...

2010-04-01

215

Update on Randomized Controlled Clinical trial data  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

216

Regulatory issues for clinical gene therapy trials.  

Science.gov (United States)

Gene therapy trials are among the most heavily regulated clinical trials. In this review, the basic tenets of human subject research are discussed in the context of the regulatory bodies which oversee this work. The challenges faced by academic research are outlined, including new and proposed regulations which impact human gene therapy investigators. PMID:12133267

Cornetta, Kenneth; Smith, Franklin O

2002-07-01

217

Planning Clinical Trials and Navigating Regulatory Requirements  

Science.gov (United States)

National and regional regulatory authorities have heightened the level of oversight and regulation required for clinical trials in recent years. So, when trials are conducted in more than one country, the differing regulations can be complicated and difficult to navigate. This checklist explains the requirements for collaborating with U.S.-based groups.

218

Feedback after Good Trials Enhances Learning  

Science.gov (United States)

Recent studies (Chiviacowsky & Wulf, 2002, 2005) have shown that learners prefer to receive feedback after they believe they had a "good" rather than "poor" trial. The present study followed up on this finding and examined whether learning would benefit if individuals received feedback after good relative to poor trials. Participants practiced a…

Chiviacowsky, Suzete; Wulf, Gabriele

2007-01-01

219

The Eichmann Trial on East German Television  

Directory of Open Access Journals (Sweden)

Full Text Available The trial against Adolf Eichmann was one of the first transnational media events on television. Its world-wide coverage required transnational cooperation. Using East German television reports about the trial this article argues that although the event transcended national borders it maintained at the same time ideological boundaries.

Judith Keilbach

2014-06-01

220

Carotene and Retinol Efficacy Trial (CARET)  

Science.gov (United States)

The Carotene and Retinol Efficacy Trial (CARET) was a randomized, double-blind, placebo-controlled trial of the cancer prevention efficacy and safety of a daily combination of 30 milligrams (mg) of beta-carotene and 25,000 IU of retinyl palmitate in 18,314 persons who were at high risk for lung cancer.

 
 
 
 
221

The WHO Vaccine Trial Registry.  

Science.gov (United States)

The WHO Vaccine Trial Registry prospectively registers clinical vaccine studies supported by WHO. Through December 1999, the registry includes 103 studies from 43 countries, with nearly 80% in developing countries. The registry documents an expanding research capacity, with an average of 3.9 new studies per year during 1987-1993, rising to 10.7 per year during 1994-2000. The studies concern a broad spectrum of infectious organisms, including: Clostridium tetani (tetanus), dengue virus, enterotoxigenic Escherichia coli (ETEC), Haemophilus influenzae type b (Hib), hepatitis B virus, measles virus, Mycobacterium tuberculosis, Neisseria meningitidis (meningococcus), poliovirus, respiratory syncytial virus (RSV), rotavirus, Salmonella typhi, Shigella, Streptococcus pneumoniae (pneumococcus), and Vibrio cholerae. PMID:11567743

Robertson, S E; Mayans, M V; El-Husseiny, A; Clemens, J D; Ivanoff, B

2001-10-12

222

Marketing and clinical trials: a case study  

Directory of Open Access Journals (Sweden)

Full Text Available 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, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

Entwistle Vikki A

2007-11-01

223

Ethics of clinical trials in Nigeria.  

Science.gov (United States)

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

Okonta, Patrick I

2014-05-01

224

28 CFR 52.02 - Criminal proceedings: Pretrial, trial.  

Science.gov (United States)

... 2010-07-01 false Criminal proceedings: Pretrial, trial...MAGISTRATE JUDGES § 52.02 Criminal proceedings: Pretrial, trial...judge to hear and determine criminal pretrial matters pending...the defendant that he has a right to elect “trial,...

2010-07-01

225

Methodological Issues in Conducting Treatment Trials for Psychological Nonepileptic Seizures  

Digital Repository Infrastructure Vision for European Research (DRIVER)

A randomized, placebo-controlled trial has yet to be completed in patients with psychological non-epileptic seizures (NES). Treatment publications for NES are limited to class III trials and class IV reports. Little is written on the methodology of treatment trials in NES. The authors describe the procedures and limitations of such a trial to inform future NES treatment trials, based on their prospective, open-label pharmacological, feasibility trial. The authors review the recruitment, enrol...

Lafrance, W. Curt; Blum, Andrew S.; Miller, Ivan W.; Ryan, Christine E.; Keitner, Gabor I.

2007-01-01

226

The selection of cases for randomised trials: a registry survey of concurrent trial and non-trial patients. The British Stomach Cancer Group.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

A randomised trial of adjuvant chemotherapy vs placebo in operable stomach cancer recruited 249 patients from the West Midlands Region between 1976-1980. A Cancer Registry survey identified a further 1261 suitable concurrent cases. Trial patients were compared with the 960 non-trial cases from participating Districts. Only 493 (51%) non-trial cases passed all of the prospective trial selection criteria for entry. Stage and fitness caused the majority of exclusions and were also highly prognos...

Ward, L. C.; Fielding, J. W.; Dunn, J. A.; Kelly, K. A.

1992-01-01

227

Data considerations in ischemic stroke trials.  

Science.gov (United States)

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

Liebeskind, David S; Feldmann, Edward

2014-05-01

228

Trial participation disclosure and gel use behavior in the CAPRISA 004 tenofovir gel trial  

Science.gov (United States)

Disclosure, or open communication, by female microbicide trial participants of their trial participation and use of an investigational HIV prevention drug to a sexual partner may affect participants' trial product usage behavior and contribute to poor adherence. With mixed results from recent microbicide clinical trials being linked to differing participant adherence, insights into the communication dynamics between trial participants and their sexual partners are particularly important. We examined the quantitative association between (1) communication of trial participation to a partner and participant adherence to gel and (2) communication of trial participation to a partner and participant HIV status. An in-depth adherence and product acceptability assessment was administered to the women participating in the CAPRISA 004 trial. Additionally, we collected qualitative data related to communication of trial participation and gel use. Qualitatively, among 165 women who had reported that they had discussed trial participation with others, most (68%) stated that they communicated participation to their sexual partner. Most of the women who had communicated study participation with their partners had received a positive/neutral response from their partner. Some of these women stated that gel use was easy; only a small number said that gel use was difficult. Among women who did not communicate their study participation to their partners, difficulty with gel use was more common and some women stated that they feared communicating their participation. Quantitatively, there was no statistically significant difference in the proportions of women who had communicated study participation to a partner across different adherence levels or HIV status. A deeper knowledge of the dynamics surrounding trial participation communication to male partners will be critical to understanding the spectrum of trial product usage behavior, and ultimately to designing tailored strategies to assist trial participants with product adherence. PMID:25285564

Succop, Stacey M.; MacQueen, Kathleen M.; van Loggerenberg, Francois; Majola, Nelisile; Karim, Quarraisha Abdool; Karim, Salim S. Abdool

2014-01-01

229

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

230

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

Directory of Open Access Journals (Sweden)

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

Fockens Paul

2010-07-01

231

Putting trials on trial--the costs and consequences of small trials in depression: a systematic review of methodology.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

STUDY OBJECTIVE: To determine why, despite 122 randomised controlled trials, there is no consensus about whether the selective serotonin reuptake inhibitors or tricyclic and related antidepressants should be used as first line treatment of depression. DESIGN: Systematic review of all RCTs comparing selective serotonin reuptake inhibitors and tricyclic or heterocyclic antidepressants. MAIN RESULTS: The shortcomings identified in the 122 trials were as follows: (1) there was inadequate descript...

Hotopf, M.; Lewis, G.; Normand, C.

1997-01-01

232

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

233

Efficacy, effectiveness, and behavior change trials in exercise research  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background The widespread incorporation of behavioral support interventions into exercise trials has sometimes caused confusion concerning the primary purpose of a trial. The purpose of the present paper is to offer some conceptual and methodological distinctions among three types of exercise trials with a view towards improving their design, conduct, reporting, and interpretation. Discussion Exercise trials can be divided into "health outcome trials" or "behavior change trials" based on their primary outcome. Health outcome trials can be further divided into efficacy and effectiveness trials based on their potential for dissemination into practice. Exercise efficacy trials may achieve high levels of exercise adherence by supervising the exercise over a short intervention period ("traditional" exercise efficacy trials or by the adoption of an extensive behavioral support intervention designed to accommodate unsupervised exercise and/or an extended intervention period ("contemporary" exercise efficacy trials. Exercise effectiveness trials may emanate from the desire to test exercise interventions with proven efficacy ("traditional" exercise effectiveness trials or the desire to test behavioral support interventions with proven feasibility ("contemporary" exercise effectiveness trials. Efficacy, effectiveness, and behavior change trials often differ in terms of their primary and secondary outcomes, theoretical models adopted, selection of participants, nature of the exercise and comparison interventions, nature of the behavioral support intervention, sample size calculation, and interpretation of trial results. Summary Exercise researchers are encouraged to clarify the primary purpose of their trial to facilitate its design, conduct, and interpretation.

Courneya Kerry S

2010-11-01

234

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

International Nuclear Information System (INIS)

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

235

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

236

Where do imaging clinical trials take place?  

Science.gov (United States)

Imaging clinical trials take place in doctor's offices, cancer centers, other medical centers, community hospitals and clinics, and veterans' and military hospitals in cities and towns across the United States and in other countries. Imaging clinical

237

7 CFR 1755.3 - Field trials.  

Science.gov (United States)

...operational effectiveness of a new or revised product...equipment derived from new inventions or concepts untried within...for a field trial, the new and improved materials...Coaxial cable system electronics; (vi) Fiber...

2010-01-01

238

Ebola Drug Shows Promise in Monkey Trial  

Science.gov (United States)

... sharing features on this page, please enable JavaScript. Ebola Drug Shows Promise in Monkey Trial Experimental medicine ... Mozes Tuesday, February 10, 2015 Related MedlinePlus Page Ebola TUESDAY, Feb. 10, 2015 (HealthDay News) -- An investigational ...

239

Clinical trials in systemic lupus erythematosus: a status report on ongoing trials.  

Science.gov (United States)

To describe the characteristics of trials in systemic lupus erythematous (SLE) listed in ClinicalTrials.gov such as study design, funding sources and aspects of the disease and drugs under investigation. We conducted a survey of ongoing clinical trials that were registered in the ClinicalTrials.gov website. We used the advanced search option and applied the following inclusion criteria, "SLE," "open studies," "interventional," and "adults 18 years or older." Of 97 eligible studies, 34.0 % were phase 3 or 4, 49.5 % were phase 1, 2 or 2/3 and in 16.5 %, we could not determine the study phase. Most trials were randomized (69.0 %) and 48.4 % were double blinded; 34 % of the trials were placebo controlled, 19.6 % had an active agent comparator and 46.4 % had no comparator. Universities and pharmaceutical industries were the primary sponsors for 45.3 and 39.1 % of the trials, respectively, and government agencies for 10.3 %. Multi-center trials based in the USA (US) accounted for 40.2 % of the trials, 46.4 % were outside of the US and 13.4 % were in the US as well as other countries. The most frequently used endpoint was drug efficacy (30.9 %) followed by disease severity indices (25.7 %), drug safety (14.4 %), remission rates and times to remission (7.2 %), and inflammatory markers and antibody titers (7.2 %). The majority of ongoing clinical trials in SLE are university or industry-funded, randomized phase 1, 2, or 2/3 trials, focused on drug efficacy. Federal funding for trials in SLE within and outside the US remains low. PMID:24752544

Gumber, Divya; Paul, Jisna; Ranganathan, Prabha

2014-12-01

240

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

Even in well-controlled laboratory environments, apparently identical repetitions of an experimental trial can give rise to highly variable perceptual outcomes and behavioral responses. This variability is generally discarded as a reflection of intrinsic noise in neuronal systems. However, part of this variability may be accounted for by trial-by-trial fluctuations of the phase of ongoing oscillations at the moment of stimulus presentation. For example, the phase of an electro-encephalogram (...

RufinVanRullen; NikoBusch; JulienDubois

2011-01-01

 
 
 
 
241

Psoriatic arthritis assessment tools in clinical trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

In order to measure disease activity, progression, and change with therapy in psoriatic arthritis (PsA), it is important to use accurate, reliable, and feasible outcome measures that can ideally be employed in longitudinal cohorts, clinical trials, and clinical practice. Until recently, there has been little focus on this methodology in PsA. Clinical trials and long term clinical registries have used disparate outcome measures. With emerging therapies, the focus on the methodology of outcome ...

Mease, P.; Antoni, C.; Gladman, D.; Taylor, W.

2005-01-01

242

The Hawthorne Effect: a randomised, controlled trial  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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.

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

2007-01-01

243

Rationale for the tinnitus retraining therapy trial  

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

Formby, Craig; Scherer, Roberta

2013-01-01

244

Quality of clinical trials: A moving target  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Bhatt, Arun

2011-01-01

245

Randomization in substance abuse clinical trials  

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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 tot...

Woolson Robert F; Hedden Sarra L; Malcolm Robert J

2006-01-01

246

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

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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

247

Cancer Screening Trials: Nuts and Bolts  

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

Prorok, Philip C.; Marcus, Pamela M.

2010-01-01

248

Ethical Issues in Clinical Trials Involving Nanomedicine  

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

Resnik, David B.; Tinkle, Sally S.

2006-01-01

249

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

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

Bero Lisa

2009-12-01

250

Relational Dynamics in Perception: Impacts on trial-to-trial variation  

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Full Text Available We show that trial-to-trial variability in sensory detection of a weak visual stimulus is dramatically diminished when rather than presenting a fixed stimulus contrast, fluctuations in a subject's judgment are matched by fluctuations in stimulus contrast. This attenuation of fluctuations does not involve a change in the subject's psychometric function. The result is consistent with the interpretation of trial-to-trial variability in this sensory detection task being a high-level meta-cognitive control process that explores for something that our brains are so used to: subject-object relational dynamics.

ShimonMarom

2011-04-01

251

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

... Those accusations were epitomised in a book, Bad Pharma by Ben Goldacre, a research fellow of epidemiology at the London School of Hygiene and Tropical Medicine, and a co-founder of the transparency campaign All Trials. Earlier this year, the European Federation of Pharmaceutical Industries and Associations (EFPIA) made new commitments, which include improving data sharing with researchers, enhancing public access to clinical study information, sharing results with patients who participate in clinical trials, certifying producers for sharing clinical trial information and publishing clinical trial results....

252

[Searching clinical trials registries: procedure and documentation].  

Science.gov (United States)

The identification of unpublished data is an important component in the assessment of drugs for a systematic review. This is why searching in clinical trials registries is indispensable. However, this type of search is not regularly conducted. At present, clinical trials registries that also contain results data are still seldom-used sources, which may be due to a number of reasons. On the one hand, there are a large number of clinical trials registries whose quality is difficult to judge sometimes; on the other hand, their heterogeneity and partly inadequate functionality such as, for example, the lack of export options, complicate searches of these sources. The present paper addresses the features of searches in clinical trials registries and describes the approach taken by the German Institute for Quality and Efficiency in Health Care (IQWiG). Initially, we describe the various types of registries and offer assistance with the selection of the clinical trials registries to be searched. A further focus lies on the description of the search procedure itself, as well as on the selection of the relevant registry entries and the documentation of this process in order to support those planning their own search in clinical trials registries. PMID:20701108

Hausner, Elke; Kaiser, Thomas

2010-01-01

253

IPF clinical trial design and endpoints  

Science.gov (United States)

Purpose of review There remains a dire need for therapies that impact the clinical course of patients with idiopathic pulmonary fibrosis (IPF). Indeed, there is a surge of interest in IPF therapeutics, with many candidate agents in various stages of development. Optimal design and implementation of the appropriate prospective clinical trials are essential to demonstrate clinical efficacy of promising drugs for the treatment of IPF. A key element in the success of such clinical trials is the choice of the best endpoint(s) to match the design of the study. Recent findings Although the results of many IPF clinical trials have been disappointing, these trials have provided valuable insights into the epidemiology and natural history of the disease and have sparked debate into the best clinical trial designs and endpoints. Summary This review will discuss the various clinical trial endpoints that have been used or proposed with a focus on their potential utility, as well as possible pitfalls that investigators should consider in the design of such studies. Video abstract http://links.lww.com/COPM/A13 PMID:25022315

Nathan, Steven D.; Meyer, Keith C.

2014-01-01

254

Decision support tools for clinical trial design.  

Science.gov (United States)

Many published clinical trials are poorly designed, suggesting that the protocol was incomplete, disorganised, or contained errors. This fact motivated the development of a suite of decision support tools for the design of randomised controlled clinical trials. In this paper we describe these tools, discussing both underlying theoretical issues and usage of the tools. The core tool--Design-a-Trial (DaT)--critiques data entered so as to guide design of a scientifically and ethically sound trial. DaT outputs a text protocol describing the trial, and a corresponding symbolic representation. Linked to DaT is a tool for authoring plans that form part of the trial. A key feature of this tool is the provision of macros for describing commonly occurring plan constructs. We describe another linked tool which generates solutions to Prolog queries requesting advice on how a plan should be revised so as to comply with safety and efficacy requirements. The user is able to navigate a path through the solution search space by interacting with natural language representations of the Prolog sub-goals. This provides the flexibility to generate useful and informative partial solutions, symbolic and textual, for inclusion in the symbolic plan representation and protocol document, respectively. PMID:12636978

Modgil, S; Hammond, P

2003-02-01

255

Implementation of the NCI’s National Clinical Trials Network  

Science.gov (United States)

NCI is launching a new clinical trials research network intended to improve treatment for the more than 1.6 million Americans diagnosed with cancer each year. The new system, NCI’s National Clinical Trials Network (NCTN), will facilitate the rapid initiation and completion of cancer clinical trials at over 3,000 clinical trials sites.

256

A Comparison of Randomised Controlled Trials in Health and Education  

Science.gov (United States)

Health care and educational trials face similar methodological challenges. Methodological reviews of health care trials have shown that a significant proportion have methodological flaws. Whether or not educational trials have a similar proportion of poor-quality trials is unknown. The authors undertook a methodological comparison between health…

Torgerson, Carole J.; Torgerson, David J.; Birks, Yvonne F.; Porthouse, Jill

2005-01-01

257

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.

258

Intravenous magnesium prevents atrial fibrillation after coronary artery bypass grafting: a meta-analysis of 7 double-blind, placebo-controlled, randomized clinical trials  

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Full Text Available Abstract Background Postoperative atrial fibrillation (POAF is the most common complication after coronary artery bypass grafting (CABG. The preventive effect of magnesium on POAF is not well known. This meta-analysis was undertaken to assess the efficacy of intravenous magnesium on the prevention of POAF after CABG. Methods Eligible studies were identified from electronic databases (Medline, Embase, and the Cochrane Library. The primary outcome measure was the incidence of POAF. The meta-analysis was performed with the fixed-effect model or random-effect model according to heterogeneity. Results Seven double-blind, placebo-controlled, randomized clinical trials met the inclusion criteria including 1,028 participants. The pooled results showed that intravenous magnesium reduced the incidence of POAF by 36% (RR 0.64; 95% confidence interval (CI 0.50-0.83; P = 0.001; with no heterogeneity between trials (heterogeneity P = 0.8, I2 = 0%. Conclusions This meta-analysis indicates that intravenous magnesium significantly reduces the incidence of POAF after CABG. This finding encourages the use of intravenous magnesium as an alternative to prevent POAF after CABG. But more high quality randomized clinical trials are still need to confirm the safety.

Gu Wan-Jie

2012-04-01

259

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

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

Craig Fiona F

2012-04-01

260

A General Framework for the Evaluation of Clinical Trial Quality  

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Flawed evaluation of clinical trial quality allows flawed trials to thrive (get funded, obtain IRB approval, get published, serve as the basis of regulatory approval, and set policy). A reasonable evaluation of clinical trial quality must recognize that any one of a large number of potential biases could by itself completely invalidate the trial results. In addition, clever new ways to distort trial results toward a favored outcome may be devised at any time. Finally, the vested financial and...

Berger, Vance W.; Alperson, Sunny Y.

2009-01-01

 
 
 
 
261

Internet trials: participant experiences and perspectives  

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

Mathieu Erin

2012-10-01

262

Randomised clinical trials of choroidal melanoma treatment.  

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

Straatsma Bradley

2003-01-01

263

The Trial of Napoleon: A Case Study for Using Mock Trials.  

Science.gov (United States)

Describes a course entitled "The Trial of Napoleon Bonaparte" that focuses on a fictitious mock trial of Napoleon Bonaparte to answer the question: did Napoleon pervert or preserve the gain of the French Revolution? Discusses the strengths and weaknesses of the course. (CMK)

MacKay, Charles

2000-01-01

264

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

Science.gov (United States)

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

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

2009-01-01

265

Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: clinical trial design  

Digital Repository Infrastructure Vision for European Research (DRIVER)

The International Campaign for Cures of Spinal Cord Injury Paralysis established a panel tasked with reviewing the methodology for clinical trials for spinal cord injury (SCI), and making recommendations on the conduct of future trials. This is the fourth of four papers. Here, we examine the phases of a clinical trial program, the elements, types, and protocols for valid clinical trial design. The most rigorous and valid SCI clinical trial would be a prospective double-blind randomized contro...

Lammertse, D.; Tuszynski, Mh; Steeves, Jd; Curt, A.; Fawcett, Jw; Rask, C.; Ditunno, Jf; Fehlings, Mg; Guest, Jd; Ellaway, Ph; Kleitman, N.; Blight, Ar; Dobkin, Bh; Grossman, R.; Katoh, H.

2006-01-01

266

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

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Full Text Available Even in well-controlled laboratory environments, apparently identical repetitions of an experimental trial can give rise to highly variable perceptual outcomes and behavioral responses. This variability is generally discarded as a reflection of intrinsic noise in neuronal systems. However, part of this variability may be accounted for by trial-by-trial fluctuations of the phase of ongoing oscillations at the moment of stimulus presentation. For example, the phase of an EEG oscillation reflecting the rapid waxing and waning of sustained attention can predict the perception of a subsequent visual stimulus at threshold. Similar ongoing periodicities account for a portion of the trial-by-trial variability of visual reaction times. We review the available experimental evidence linking ongoing EEG phase to perceptual and attentional variability, and the corresponding methodology. We propose future tests of this relation, and discuss the theoretical implications for understanding the neuronal dynamics of sensory perception.

RufinVanRullen

2011-04-01

267

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

268

Biomarkers in T cell therapy clinical trials  

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

Kalos Michael

2011-08-01

269

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

270

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

271

Franz Kafka's The Trial: guilty or innocent?  

Science.gov (United States)

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

Siegel, E

1996-07-01

272

Problems and alternatives to classical randomized trials  

International Nuclear Information System (INIS)

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

273

The Hawthorne Effect: a randomised, controlled trial  

Directory of Open Access Journals (Sweden)

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

van Haselen Robbert

2007-07-01

274

General pretrial publicity in sexual assault trials.  

Science.gov (United States)

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

Woody, William Douglas; Viney, Wayne

2007-10-01

275

Powered toothbrushes: a review of clinical trials.  

Science.gov (United States)

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

Heasman, P A; McCracken, G I

1999-07-01

276

The Statistics of Phase 0 Trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

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

2010-01-01

277

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

278

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.

279

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

Science.gov (United States)

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

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

2015-02-01

280

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

 
 
 
 
281

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)

282

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.

283

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.

284

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

285

Contact the Coordinating Center for Clinical Trials  

Science.gov (United States)

Contact the Coordinating Center for Clinical Trials Office of the DirectorNational Cancer Institute9609 Medical Center DriveBethesda, MD 20892-9774Phone: 240-276-6160Fax: 240-276-7876Email: NCICCCT@mail.nih.govInternet: http://cancer.gov/aboutnci/organization/ccct CCCT

286

New Data from HPV Vaccine Trials Available  

Science.gov (United States)

Results from three years of follow-up data from two clinical trials of Gardasil, a vaccine that protects against the HPV viruses known to cause 70 percent of all cases of cervical cancer, have been published in the May 10, 2007, New England Journal of Medicine.

287

Cytomegalovirus vaccine: phase II clinical trial results.  

Science.gov (United States)

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

Rieder, F; Steininger, C

2014-05-01

288

Blast densification trials for oilsands tailings  

Energy Technology Data Exchange (ETDEWEB)

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

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

2010-07-01

289

Personalized Treatment Trial for Breast Cancer Launched  

Science.gov (United States)

The Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, was launched on May 23, 2006, to examine whether genes that are frequently associated with risk of recurrence for women with early-stage breast cancer can be used to assign patients to the most appropriate and effective treatment. Questions and Answers, TAILORx en Español

290

Trial industrial mining-separation complex  

International Nuclear Information System (INIS)

Full text: The report is constructed as the comment to a video clip showing work trial of industrial mining-separation complex (IMSC), working on deposit Kokpatas. In the report basic cycles of the technological circuit of enrichment gold-containing on IMSC are explained, and the special attention is given work of irradiation-measuring (IMD) and separating (SD) devices

291

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)

292

Informed consent doesn't exist in AMI trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Hilden and Gammelgaard's (H&G) comments on the evaluation and application of statistical trials and on informed consent lead to the same conclusion that there are special circumstances when clinical trials are performed in emergency situations.

Verdu-pascual, F.; Castello-ponce, A.

2002-01-01

293

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 ...

294

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

295

Randomized phase II trials: time for a new era in clinical trial design.  

Science.gov (United States)

The classic single-arm oncology phase II trial designs for evaluating an experimental regimen/agent are limited by multiple sources of bias arising from the inability to separate trial effects (such as patient selection, trial eligibility, imaging techniques and assessment schedule, and treatment locations) from treatment effect on clinical outcomes. Changes in patient population based on biologic subsetting, newer imaging technologies, the use of alternative end points, constrained resources, and the multitude of promising therapies for a given disease make randomized phase II designs, with a concurrent control arm where necessary, attractive. In this brief report, we discuss the salient features of the randomized designs for phase II trials, which when properly applied under the constraints of their underlying inference framework can assure optimal use of limited phase III financial and patient resources. PMID:20581575

Mandrekar, Sumithra J; Sargent, Daniel J

2010-07-01

296

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.

297

ADEPT - Abnormal Doppler Enteral Prescription Trial  

Directory of Open Access Journals (Sweden)

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

McCormick Kenny

2009-10-01

298

Controlled trials in epilepsy: a review.  

Science.gov (United States)

A comprehensive review, evaluating 51 randomized double-blind controlled studies, covering different aspects of epileptology, is presented. Trials were grouped according to the investigated topic and for each group an attempt was made to derive an overall conclusion. The majority of studies investigated antiepileptic drug treatments. Other topics were: psychotropic effect of antiepileptic drugs, folic acid and vitamin D administration in epilepsy, and EEG investigations. A cross-sectional analysis of items such as designs, patient sampling principles, recording of effect parameters and side effects, concomitant treatments, and statistical evaluations demonstrated that cross-over designs, investigating fixed dosage schedules, were extensively used. Less than half of these studies included a washout period between treatments, complicating the interpretation of the obtained results. The vast majority of studies involved only chronic patients; and marked heterogeneity in patient selection with respect to age, seizure type, and mental status, and severity of epilepsy was observed. Classifications of seizures varied between the studies. The most prominent effect parameter was seizure frequency. The use of heterogeneous patient samples frequently necessitated equalization of widely different seizure types in order to perform statistical analyses. The mean duration of trials was 6 months, precluding evaluation of chronic toxicity. The majority of studies recorded side effects, but data collection was rather unsystematic and statistical evaluation was seldom applied. Most studies were add-on trials, and since concomitant treatment was frequently changed during the investigations, it was difficult to evaluate the influence of this variable. A correlation analysis across trials demonstrated, among other things, that the common assumption that short controlled trials provide too optimistic results, could not be substantiated. This survey provides no firm indication of which drug is more suitable for which seizure type. PMID:6814901

Gram, L; Bentsen, K D; Parnas, J; Flachs, H

1982-10-01

299

The Radiation oncology practice standards trial  

International Nuclear Information System (INIS)

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

300

SAAB IRST: the system and flight trials  

Science.gov (United States)

Saab Bofors Dynamics has developed an IRST-system (Infra Red Search and Track) named IR-OTIS (Optical Tracking and Identification System) and flight trials have been carried out with the system mounted on a Saab JA37 Viggen fighter aircraft. This paper consists of three major parts. First an overview of Saab's IRST-programs. The second part describes the system ( IR-OTIS(Viggen) ) that made flight trials during 1998 and 1999 and finally a report from the flight trials. IR-OTIS has mainly three operating modes: 1) IRST-mode where the system covers several different FOS (Field Of Search). 2) FLIR-mode (Forward Looking IR) where the systems LOS (Line Of Sight) is directed from the aircraft. 3) Track-mode where the built-in-tracker controls the LOS. It is also possible to switch from IRST-mode to track-mode automatically. Physically the IR-OTIS(Viggen) consists of the SU (Sensor Unit) and the SPU (Signal Processing Unit). The SU is operating in the longwave IR-band with a 288*4 detector. In all modes the Sensor Unit generates images in 25 Hz and it is also possible to choose one of three FOV. The SPU consists of a Saab designed image processing hardware and several DSPs. Functions in the SPU includes a scene-based NUC (Non Uniformity Correction), anti-Narcissus, a point-target detector including estimation of SNR and a clutter classifier for CFAR, target association, a correlation target tracker and an AGC for image presentation. We carried out over 50 flight trials during 1998 and 1999 in three different rounds. The functionality of the system has increased during the rounds and at the end of the trials all major goals were achieved.

Andersson, Ingmar A.; Haglund, Leif

2003-01-01

 
 
 
 
301

RTOG: Updated results of randomized trials  

International Nuclear Information System (INIS)

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

302

Can we identify non-stationary dynamics of trial-to-trial variability?  

Science.gov (United States)

Identifying sources of the apparent variability in non-stationary scenarios is a fundamental problem in many biological data analysis settings. For instance, neurophysiological responses to the same task often vary from each repetition of the same experiment (trial) to the next. The origin and functional role of this observed variability is one of the fundamental questions in neuroscience. The nature of such trial-to-trial dynamics however remains largely elusive to current data analysis approaches. A range of strategies have been proposed in modalities such as electro-encephalography but gaining a fundamental insight into latent sources of trial-to-trial variability in neural recordings is still a major challenge. In this paper, we present a proof-of-concept study to the analysis of trial-to-trial variability dynamics founded on non-autonomous dynamical systems. At this initial stage, we evaluate the capacity of a simple statistic based on the behaviour of trajectories in classification settings, the trajectory coherence, in order to identify trial-to-trial dynamics. First, we derive the conditions leading to observable changes in datasets generated by a compact dynamical system (the Duffing equation). This canonical system plays the role of a ubiquitous model of non-stationary supervised classification problems. Second, we estimate the coherence of class-trajectories in empirically reconstructed space of system states. We show how this analysis can discern variations attributable to non-autonomous deterministic processes from stochastic fluctuations. The analyses are benchmarked using simulated and two different real datasets which have been shown to exhibit attractor dynamics. As an illustrative example, we focused on the analysis of the rat's frontal cortex ensemble dynamics during a decision-making task. Results suggest that, in line with recent hypotheses, rather than internal noise, it is the deterministic trend which most likely underlies the observed trial-to-trial variability. Thus, the empirical tool developed within this study potentially allows us to infer the source of variability in in-vivo neural recordings. PMID:24769735

Balaguer-Ballester, Emili; Tabas-Diaz, Alejandro; Budka, Marcin

2014-01-01

303

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

Science.gov (United States)

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

MacDonald, Brett; Barry, Robert J

2014-06-01

304

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

305

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

306

Trial-by-Trial Adaptation of Movements during Mental Practice under Force Field  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Human nervous system tries to minimize the effect of any external perturbing force by bringing modifications in the internal model. These modifications affect the subsequent motor commands generated by the nervous system. Adaptive compensation along with the appropriate modifications of internal model helps in reducing human movement errors. In the current study, we studied how motor imagery influences trial-to-trial learning in a robot-based adaptation task. Two groups of subjects performed ...

Anwar, Muhammad Nabeel; Khan, Salman Hameed

2013-01-01

307

Analysis of repeated measurement data in the clinical trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

308

Continental cement trial burn strategy follow-up  

Energy Technology Data Exchange (ETDEWEB)

The Continental Trial Burn strategy, presented at the 1995 BIF Conference, included the use of {open_quotes}data-in-lieu-of{close_quotes} from previous compliance testing conducted at the facility. Since the submission of the Trial Burn Plan and the 1995 presentation, Continental Cement has completed their two campaign trial burn. This paper will update the implementation of the Continental Trial Burn strategy. 1 fig., 1 tab.

Woodford, J. [Gossman Consulting, Inc., Springboro, OH (United States); Winders, H. [Continental Cement Company, Hannibal, MO (United States); Constans, D.L. [Gossman Consulting, Inc., Peachtree City, GA (United States)

1997-12-31

309

Clinical Trial Design Issues in Mild to Moderate Alzheimer Disease  

Digital Repository Infrastructure Vision for European Research (DRIVER)

The field of clinical trials and therapeutics in Alzheimer Disease (AD) is little more than 20 years old. Considerable progress has been made in crafting appropriate designs for clinical trials of promising therapeutic agents for AD. This article reviews basic issues in diagnostic criteria, choice of outcome measures, duration of trials and analytic strategies. Through trial and error, a general set of strategies has evolved for the assessment of putative therapies for mild to moderate AD. Th...

Knopman, David S.

2008-01-01

310

Cluster randomised trials in the medical literature: two bibliometric surveys  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Martin, Bland J.

2004-01-01

311

The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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 ...

Bristow Michael R; Eichhorn Eric J

2001-01-01

312

Good clinical practice: International quality standard for clinical trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

A clinical trial is one of the most important examples of experimental studies. Clinical trials represent an indispensable tool for testing, in a rigorous scientific manner, the efficacy of new therapies. Good Clinical Practice is an international ethical and scientific quality standard for clinical trials, concerning the design, conduct, performance, monitoring auditing, recording, analysis and reporting. This is an assurance to the public that the rights, safety and well-being of trial subj...

Radulovi? Siniša S.

2003-01-01

313

Registering clinical trials in India: a scientific and ethical imperative.  

Science.gov (United States)

The Clinical Trials Registery-India is an online, primary register of the WHO's International Clinical Trials Registry Platform. It was launched on 20 July 2007, and is now open to the prospective registration of clinical trials of any intervention conducted in India involving human participants. Registration is voluntary and free, and the register is searchable free of charge. Public disclosure of all 20 items in the WHO Trial Registration Data Set is mandatory for a valid registration number to be allocated. This number is required if the results are to be published in journals that endorse the International Committee of Medical Journal Editors' position on prospective trials registration. Trials in the Clinical Trials Registery-India will be included in the central repository of the WHO's International Clinical Trials Registry Platform search portal. In addition to the 20 items, the Clinical Trials Registery-India also requires mandatory disclosure of details of ethics committee and regulatory clearances. Further items pertaining to the methods that improve the internal validity of the trial are optional and serve as a template to improve trial design and the reliability of results. The success of this endeavour depends on the cooperation of the pharmaceutical industry, academic institutions, medical associations, ethics committees and medical journal editors in India. In the absence of legislation, ethics committees and medical journal editors have an important role in ensuring prospective registration of trials. PMID:18472701

Tharyan, Prathap; Ghersi, Davina

2008-01-01

314

46 CFR 58.01-30 - Trial-trip observance.  

Science.gov (United States)

...2010-10-01 2010-10-01 false Trial-trip observance. 58.01-30 Section 58...Requirements § 58.01-30 Trial-trip observance. The operation of main...auxiliaries shall be observed on the trial trip of each new vessel and all...

2010-10-01

315

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

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Background: Impairments of cognitive control have been theorized to drive the repetitive thoughts and behaviors of obsessive compulsive disorder (OCD) from early in the course of illness. However, it remains unclear whether altered trial-by-trial adjustment of cognitive control characterizes young patients. To test this hypothesis, we determined whether trial-by-trial adjustments of cognitive control are altered in children with OCD, relative to healthy controls. Methods: Forty-eight ...

YanniLiu; WilliamJGehring

2012-01-01

316

Media reporting of tenofovir trials in Cambodia and Cameroon  

Directory of Open Access Journals (Sweden)

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

Wong Elaine

2005-08-01

317

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

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

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

2011-01-01

318

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.)

319

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

Science.gov (United States)

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

Karagiannis, Martha; Karagiannis, Tom C

2014-01-01

320

Single-trial discrimination for integrating simultaneous EEG and fMRI: Identifying cortical areas contributing to trial-to-trial variability in the auditory oddball task  

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The auditory oddball task is a well-studied stimulus paradigm used to investigate the neural correlates of simple target detection. It elicits several classic event-related potentials (ERPs), the most prominent being the P300 which is seen as a neural correlate of subjects' detection of rare (target) stimuli. Though trial-averaging is typically used to identify and characterize such ERPs, their latency and amplitude can vary on a trial-to-trial basis reflecting variability in the underlying n...

Goldman, Robin I.; Wei, Cheng-yu; Philiastides, Marios G.; Gerson, Adam D.; Friedman, David; Brown, Truman R.; Sajda, Paul

2009-01-01

 
 
 
 
321

Randomized clinical trials with biomarkers: design issues.  

Science.gov (United States)

Clinical biomarker tests that aid in making treatment decisions will play an important role in achieving personalized medicine for cancer patients. Definitive evaluation of the clinical utility of these biomarkers requires conducting large randomized clinical trials (RCTs). Efficient RCT design is therefore crucial for timely introduction of these medical advances into clinical practice, and a variety of designs have been proposed for this purpose. To guide design and interpretation of RCTs evaluating biomarkers, we present an in-depth comparison of advantages and disadvantages of the commonly used designs. Key aspects of the discussion include efficiency comparisons and special interim monitoring issues that arise because of the complexity of these RCTs. Important ongoing and completed trials are used as examples. We conclude that, in most settings, randomized biomarker-stratified designs (ie, designs that use the biomarker to guide analysis but not treatment assignment) should be used to obtain a rigorous assessment of biomarker clinical utility. PMID:20075367

Freidlin, Boris; McShane, Lisa M; Korn, Edward L

2010-02-01

322

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

323

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

324

Clinical trials in hepatocellular carcinoma: an update.  

Science.gov (United States)

The success of sorafenib has spurred an explosive increase of clinical trials testing novel molecular targets and other agents in the treatment of hepatocellular carcinoma (HCC). The paradigm of the studies has been characterized by three noticeable changes. First, the molecular targets of interest have expanded from angiogenesis to cancer cell-directed oncogenic signaling pathways for advanced HCC treatment. Agents targeting EGFR, FGFR, PI3K/Akt/mTOR, TGF-?, c-Met, MEK, IGF signaling, and histone deacetylase have been actively explored. Second, the target indication has shifted from advanced stage to early or intermediate stages of disease. The feasibility of combining locoregional therapies and targeted agents, and the use of novel agents after curative treatments are currently under active investigation. Finally, the therapeutic strategy has shifted from monotherapy to combination targeted therapy. We aim to provide a comprehensive overview of newly disclosed and ongoing clinical trials for the treatment of HCC. PMID:24400222

Shen, Ying-Chun; Lin, Zhong-Zhe; Hsu, Chih-Hung; Hsu, Chiun; Shao, Yu-Yun; Cheng, Ann-Lii

2013-08-01

325

Bayesian Adaptive Randomization Designs for Clinical Trial  

Directory of Open Access Journals (Sweden)

Full Text Available Bayesian Adaptive Randomization Design (BARD is widely used in clinical trials, this design allow to adaptively assign patients to the better treatment. The aim of this study is to compare the potential of Simple Bayesian Adaptive Randomization Design (SBARD with two common designs (Pocock and O’Brien Flemming, in detecting the effect of treatments. The 5,000 simulations are done to evaluate the performance of SBARD and the two common designs under the same clinical scenarios. The operating characteristics of the SBARD and two common designs are presented. We found that, under scenario 4, the SBARD has greater power (0.938 than the Pocock and O’Brien Flemming designs in detecting the difference between control and treatment arms, using small number of total subjects (116 vs., 292, 600. The SBARD design would be one of the simplest design incorporates with the short term outcomes in clinical trial.

Busaba Supawattanabodee

2015-01-01

326

Malaria vaccines: lessons from field trials  

Directory of Open Access Journals (Sweden)

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

Struchiner Claudio J.

1994-01-01

327

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

328

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.)

329

Adaptive Allocation Theory in Clinical Trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Various adaptive randomization procedures (adaptive designs) have been proposed to clinical trials. This paper discusses several broad families of procedures, such as the play-the-winner rule and Markov chain model, randomized play-the-winner rule and urn models, drop-the-loser rule, doubly biased coin adaptive design. Asymptotic theories are presented with several pivotal proofs. The effect of delayed responses, the power and variability comparison of these designs are also...

Zhang, Li-xin

2006-01-01

330

Clinical and Therapeutic Trials of Nigella Sativa  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Salama, Ragaa H. M.

2010-01-01

331

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

332

Mammographic screening: evidence from randomised controlled trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

BACKGROUND: All randomised breast cancer screening trials have shown a reduction in breast cancer mortality in the 'invited for mammography' screening arm compared with the 'control arm' for women aged 50 years and older at randomisation (overall 25%). However, individually published point estimates differ and concern has been raised about methodological quality and outcome measures. Materials and Methods Review of the evidence on breast c...

Koning, H. J.

2003-01-01

333

Randomised clinical trial of chest drainage systems.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Sarniak, R. M.

1992-01-01

334

Ethical issues in postauthorization drug trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

This thesis is an attempt to raise some ethical issues that are specific to phase IV drug trials and to provide preliminary responses to such issues. We limited ourselves to issues of informed consent, risk-benefit assessment, and the therapeutic orientation of phase IV. On the issue of informed consent (IC) and phase IV, we deliberated on issues related to form and procedure. First, we demonstrated that in phase IV non-interventional studies, though IC remains the standard, the manner of...

Bernabe, R. D. L. C.

2013-01-01

335

Clinical trials in acute ischemic stroke.  

Science.gov (United States)

Acute ischemic stroke (AIS) is a major cause of mortality and disability and remains a serious and significant global health problem. The development of neurovascular protectants to treat AIS successfully has been beset by disappointments and setbacks. Many promising candidates have lacked significant pleiotropic protective activity for brain tissue and cerebral blood vessels in clinical trials, while those with protective activity have had poor bioavailability or high toxicity. Moreover, the majority of agents did not confer significant neurovascular protection or clinical efficacy, as measured by standard behavioral endpoints in clinical trials of heterogeneous populations of patients with AIS. The recombinant tissue plasminogen activator alteplase is approved in many countries for the treatment of AIS in the first 3 h after symptom onset. Many drug candidates have been subject to clinical trials, including those with anti-excitotoxic, anti-inflammatory, antioxidant, antiapoptotic/regenerative, calcium/adrenergic-modulating/antihypertensive, thrombolytic, nootropic/stimulant, fluid regulatory, or oxygen-delivering mechanisms of action. Some agents, such as tenecteplase, edaravone and minocycline, may be approved for global use in the future. This review evaluates almost all neurovascular protectants subject to clinical trial evaluation for the treatment of AIS, and includes 241 studies conducted between 1978 and 2014. The development of agents that reduce brain injury after AIS will require new and different approaches based on a deeper understanding of the pathophysiology of AIS. Moreover, the future treatment for AIS is likely to lie in combination therapy rather than monotherapy. Additional approaches to the testing and use of neurovascular protectants should be considered. PMID:25160686

Kikuchi, Kiyoshi; Tanaka, Eiichiro; Murai, Yoshinaka; Tancharoen, Salunya

2014-10-01

336

Clinical Trials in Hepatocellular Carcinoma: An Update  

Digital Repository Infrastructure Vision for European Research (DRIVER)

The success of sorafenib has spurred an explosive increase of clinical trials testing novel molecular targets and other agents in the treatment of hepatocellular carcinoma (HCC). The paradigm of the studies has been characterized by three noticeable changes. First, the molecular targets of interest have expanded from angiogenesis to cancer cell-directed oncogenic signaling pathways for advanced HCC treatment. Agents targeting EGFR, FGFR, PI3K/Akt/mTOR, TGF-?, c-Met, MEK, IGF signaling, and h...

Shen, Ying-chun; Lin, Zhong-zhe; Hsu, Chih-hung; Hsu, Chiun; Shao, Yu-yun; Cheng, Ann-lii

2013-01-01

337

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

338

Cluster Randomized Trials With Treatment Noncompliance  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Cluster randomized trials (CRTs) have been widely used in field experiments treating a cluster of individuals as the unit of randomization. This study focused particularly on situations where CRTs are accompanied by a common complication, namely, treatment noncompliance or, more generally, intervention nonadherence. In CRTs, compliance may be related not only to individual characteristics but also to the environment of clusters individuals belong to. Therefore, analyses ignoring the connectio...

Jo, Booil; Asparouhov, Tihomir; Muthe?n, Bengt O.; Ialongo, Nicholas S.; Brown, C. Hendricks

2008-01-01

339

Continuous Glucose Monitoring and Clinical Trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

340

Evaluation of eligibility and recruitment in breast cancer clinical trials.  

Science.gov (United States)

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

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

2014-08-01

 
 
 
 
341

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

Directory of Open Access Journals (Sweden)

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

Zielinski Stephanie M

2012-01-01

342

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

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

Francis David

2006-04-01

343

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

2014-07-26

344

Adolescent experiences in a vaccine trial: a pilot study  

Scientific Electronic Library Online (English)

Full Text Available SciELO South Africa | Language: English Abstract in english ABSTRACT Little is known about how adolescents experience clinical trials. We assessed the experiences of South African adolescent participants in a clinical trial, employing semi-structured interviews to gather qualitative data on the experiences and effects of trial participation. Despite misunder [...] standing certain concepts regarding assent and trial processes subsequent to enrolment, participants reported positive experiences overall. Subjects' motivations for participation included: an ability to help others; receipt of healthcare; and free blood screening. Participants expressed fears associated with trial procedures, such as phlebotomy; however, these apprehensions diminished as the trial progressed. We found that conducting qualitative research within a trial site is feasible, and can provide insight into the uptake and acceptability of interventions.

Amber, Abrams; Nandi, Siegfried; Hennie, Geldenhuys.

2011-12-01

345

Extremity dosimetry trial: Devonport royal dockyard  

International Nuclear Information System (INIS)

This trial was undertaken to assess extremity dosemeters, which were made available to Devonport Royal Dockyard and determine the most suitable to the site. The trial included operational and laboratory-based exposures. Operational exposures were within a submarine reactor compartment and a waste storage area. Laboratory exposures were undertaken using 241Am, 137Cs and 60Co sources to compare and contrast the dosemeters energy response. In addition, the low dose response and the response if placed in the incorrect orientation were also assessed. Ten passive and two active dosemeters were tested, with three highlighted as the most technically suitable, DSTL Harshaw DXT-RAD, HPA Harshaw EXT-RAD and the AMEC Panasonic UD-807A. The most technically suitable dosemeter was the DSTL Harshaw DXT-RAD, due to good responses within all aspects of the trial and the user's preference for the ring type design. The John Caunt ED2 electronic dosemeter 2 (ED2) also performed well, but suffered radio frequency interference. (authors)

346

Moral justification of Phase 1 oncology trials.  

Science.gov (United States)

This article attempts to answer the following normative questions: Can one consider the design of Phase 1 trials ethically appropriate due to the unfavorable ratio of risks and benefits? What are some ethical safeguards for Phase 1 oncology research? A comparative review of literature contributed to the consolidation of the proposed ethical framework for Phase 1 oncology trials. This framework gives a special attention to issues of therapeutic misconception and vulnerability. The benefits and dangers associated with the enrollment in trials are described as well as the absence of alternatives, treatment-specific optimism, and vagueness in factual presentation during the informed consent process. The notion of therapeutic misconception is contrasted with optimism despite realism that stems from psychological, cultural, and religious factors and not necessarily from the lack of information. Close attention is given to the possible ways in which the inherent uncertainty and resulting cognitive biases may affect the informed consent process and the definition of therapeutic misconception. The article ends with recommendations for an ethical way of enrolling palliative patients in early stages of oncology research, giving special attention to provision of adequate consent, protection of vulnerability, and avoidance of therapeutic misconception. PMID:24813655

Dubov, Alex

2014-06-01

347

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

348

A double-blind, randomized, placebo-controlled trial of oral isotretinoin in the treatment of recalcitrant facial flat warts.  

Science.gov (United States)

Abstract Background: Recalcitrant facial flat warts are caused by human papillomavirus and may persist for years despite treatment. Isotretinoin has demonstrated benefits in the treatment of recalcitrant, genital and common warts, but placebo-controlled trials have not been performed. Objective: To determine whether isotretinoin is safe and effective for recalcitrant facial flat warts. Methods: Isotretinoin 30?mg/day or placebo was administered to 16 and 15 patients, respectively, in double-blind, randomized fashion for 12 weeks. Cutaneous lesions were assessed and adverse events including serologic and ophthalmologic changes were recorded. It is considered that warts were recalcitrant if the patient was treated for at least 3 years with at least three of the following options: retinoids, 5-fluorouracil, imiquimod and cryotherapy using liquid nitrogen. Results: Each patient in the istotretinoin group showed complete clearance of all flat warts, while none of the patients in the placebo group showed any improvement (p?=?0.0001). The most frequent adverse event was cheilitis. There were no statistically significant changes in the laboratory findings. Limitations: The study design does not permit complete blinding of the dermatologist who can easily recognize the adverse effects of isotretinoin. The clinical findings, however, were so dramatic that this would not have impacted the findings. Another limitation of the study is a lack of follow-up to assess for recurrence after the drug was discontinued. Conclusions: Isotretinoin is an effective treatment for recalcitrant flat facial warts with a well-known, manageable safety profile. PMID:24547881

Olguin-García, María Guadalupe; Jurado-Santa Cruz, Fermín; Peralta-Pedrero, María Luisa; Morales-Sánchez, Martha Alejandra

2014-02-19

349

De "corpos" a "pessoas": a atuação das pacientes através do julgamento da Dra. Mary Dixon Jones de 1892 From "bodies" to "persons": female patient agency as revealed in the 1892 trial of Dr. Mary Dixon Jones  

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Full Text Available Este artigo discute o sensacional processo de 1892 entre o jornal Eagle, Do Brooklin, Nova Iorque, e uma conhecida cirurgiã ginecologista, Dra. Mary Amanda Dixon Jones. Sugiro que o evento confirmou e ajudou a mudar a compreensão sobre o corpo feminino e as doenças ginecológicas para as pacientes, os espectadores do julgamento e o público mais amplo. O desenvolvimento da cirurgia ginecológica alterou as relações entre médico e paciente, permitindo que mulheres pobres e de classe média falassem no tribunal sobre sua penosa experiência da doença. O julgamento proporcionou um canal público incomum para a divulgação das reclamações quanto à condição feminina, assim como para discussão sobre a prática médica.This article examines a sensational public libel trial that took place in 1892 between the Brooklyn, New York, Eagle newspaper and a well-known female gynecological surgeon, Dr. Mary Amanda Dixon Jones. I suggest that the event both affirmed and helped authorized changing understandings of women's bodies and gynecological disease for female patients, trial spectators, and the larger public. It suggests that the development of gynecological surgery altered doctor-patient relationships which enabled middle class and even some poor women to speak in the courtroom about the burdensome experience of illness. The trial provided an unusual public venue for airing disappointments and complaints about the female condition, as well as the discussion about medical practices.

Regina Morantz-Sanchez

2005-06-01

350

De "corpos" a "pessoas": a atuação das pacientes através do julgamento da Dra. Mary Dixon Jones de 1892 / From "bodies" to "persons": female patient agency as revealed in the 1892 trial of Dr. Mary Dixon Jones  

Scientific Electronic Library Online (English)

Full Text Available SciELO Brazil | Language: Portuguese Abstract in portuguese Este artigo discute o sensacional processo de 1892 entre o jornal Eagle, Do Brooklin, Nova Iorque, e uma conhecida cirurgiã ginecologista, Dra. Mary Amanda Dixon Jones. Sugiro que o evento confirmou e ajudou a mudar a compreensão sobre o corpo feminino e as doenças ginecológicas para as pacientes, o [...] s espectadores do julgamento e o público mais amplo. O desenvolvimento da cirurgia ginecológica alterou as relações entre médico e paciente, permitindo que mulheres pobres e de classe média falassem no tribunal sobre sua penosa experiência da doença. O julgamento proporcionou um canal público incomum para a divulgação das reclamações quanto à condição feminina, assim como para discussão sobre a prática médica. Abstract in english This article examines a sensational public libel trial that took place in 1892 between the Brooklyn, New York, Eagle newspaper and a well-known female gynecological surgeon, Dr. Mary Amanda Dixon Jones. I suggest that the event both affirmed and helped authorized changing understandings of women's b [...] odies and gynecological disease for female patients, trial spectators, and the larger public. It suggests that the development of gynecological surgery altered doctor-patient relationships which enabled middle class and even some poor women to speak in the courtroom about the burdensome experience of illness. The trial provided an unusual public venue for airing disappointments and complaints about the female condition, as well as the discussion about medical practices.

Regina, Morantz-Sanchez.

2005-06-01

351

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

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

TimFingscheidt

2013-02-01

352

THE PRE-TRIAL CHAMBER JUDGE  

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Full Text Available The importance of this work lies in important changes in the new Code of Criminal Procedure, amendments justified by the new realities of a democratic society in which criminal procedural rules must be adapted according to the daily realities in the achievement of justice. The purpose of the paper is given by the need of approaching at a theoretically level the institution of The Pre-Trial Chamber Judge, given that so far there have not been developed any works on the subject. This paper addresses both practitioners and litigants.

Edgar Lauren?iu DUMBRAV?

2014-05-01

353

THE PRE-TRIAL CHAMBER JUDGE  

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Full Text Available The importance of this work lies in important changes in the new Code of Criminal Procedure, amendments justified by the new realities of a democratic society in which criminal procedural rules must be adapted according to the daily realities in the achievement of justice. The purpose of the paper is given by the need of approaching at a theoretically level the institution of The Pre-Trial Chamber Judge, given that so far there have not been developed any works on the subject. This paper addresses both practitioners and litigants.

Edgar Laurentiu DUMBRAVA

2014-12-01

354

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)

355

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)

356

Clinical trials of hypoxic cell sensitizers  

International Nuclear Information System (INIS)

This paper reviews the use of nitroimidazoles as radiosensitizers from their introduction into the clinical treatment of cancer with radiotherapy in 1974 to the present. Clinical trials with radiosensitizers are conventionally divided into 3 phases. Phase I included the initial escalation of drug dose and the establishment of dose limiting toxicity. The Phase II studies are directed toward specific tumor sites and histologies and genenerally involved a specific radiation regimen and a specific sensitizer drug regimen used in combination. The phase III studies are large scale investigations which are controlled and randomized. Radiosensitizer studies relevant to each phase are reviewed

357

THE RIGHT TO A FAIR TRIAL  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Among the general rights of the citizen on finds the free access to justice, the rights to defense and the right to legal security. The jurisprudence based on principles of law and on international treaties, caused the appearance, along the constitutional protection provided by default by a lawyer, of the need of fair and equitable procedures to ensure a balance in the rights of the parties. Today the right to a fair trial is a fundamental right most frequently invoked in front of Romanian co...

FLORICA BRASOVEANU

2012-01-01

358

Good clinical practice: International quality standard for clinical trials  

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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

359

Clinical trial design in the era of comparative effectiveness research  

Directory of Open Access Journals (Sweden)

Full Text Available Anke C Winter, Graham A Colditz Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St Louis, MO, USA Abstract: Clinical trials are one of the key study designs in the evolving field of comparative effectiveness research. Evaluating the effectiveness of interventions in real-world settings is complex and demands a rethinking of the traditional clinical trial approach as well as transformation of the clinical trial landscape. Novel strategies and refinement of existing approaches have been proposed to generate evidence that can guide health care stakeholders in their decision process. The purpose of this review is to discuss clinical trial design approaches in the era of comparative effectiveness research. We will focus on aspects relevant to the type of clinical trial, study population and recruitment, randomization process, outcome measures, and data collection. Keywords: review, clinical trial, comparative effectiveness research

Winter AC

2014-10-01

360

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

 
 
 
 
361

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

Science.gov (United States)

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

Torgerson, Carole J.

2009-01-01

362

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

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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

363

Analysis of Safety from a Human Clinical Trial with Pterostilbene  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

364

Application of remote sensing to agricultural field trials.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Clevers, J. G. P. W.

1993-01-01

365

Strategies to improve recruitment to randomised controlled trials.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

BACKGROUND: Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research. OBJECTIVES: To quantify the effects of strategies to improve recruitment of participants to randomised controlled trials. SEARCH STRATEGY: We searched the Cochrane Methodology Review Group Specialised Register - CMR (The Cochrane Library (online) Issue 1 2008) (searched 20 February 2008); MEDLINE, Ovid (1950 to date o...

Treweek, S.; Mitchell, E.; Pitkethly, M.; Cook, J.; Kjeldstrøm, M.; Taskila, T.; Johansen, M.; Sullivan, F.; Wilson, S.; Jackson, C.; Jones, R.

2010-01-01

366

Design, analysis and presentation of factorial randomised controlled trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Background The evaluation of more than one intervention in the same randomised controlled trial can be achieved using a parallel group design. However this requires increased sample size and can be inefficient, especially if there is also interest in considering combinations of the interventions. An alternative may be a factorial trial, where for two interventions participants are allocated to receive neither intervention, one or the other, or both. Factorial trials ...

Little Paul; Montgomery Alan A; Peters Tim J

2003-01-01

367

The clinical-economic trial: promise, problems, and challenges.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

The clinical-economic trial is a study design that is appearing with greater frequency in medical and public health literature. Some experienced investigators view these trials with skepticism; to policy makers they represent a promising step in the control of rising health care costs. The success of clinical-economic trials in meeting the important goal of more rational and efficient use of health care resources will depend on the strengths and limitations of the research method. As part of ...

Powe, Nr; Griffiths, Ri

1995-01-01

368

Clinical trial design in the era of comparative effectiveness research  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Anke C Winter, Graham A Colditz Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St Louis, MO, USA Abstract: Clinical trials are one of the key study designs in the evolving field of comparative effectiveness research. Evaluating the effectiveness of interventions in real-world settings is complex and demands a rethinking of the traditional clinical trial approach as well as transformation of the clinical trial landscape. Novel strategies a...

Ac, Winter; Ga, Colditz

2014-01-01

369

Assessing the Generalizability of Randomized Trial Results to Target Populations.  

Science.gov (United States)

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

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

2014-10-12

370

Decision support for clinical trial eligibility determination in breast cancer.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

We have developed a system for clinical trial eligibility determination where patients or primary care providers can enter clinical information about a patient and obtain a ranked list of clinical trials for which the patient is likely to be eligible. We used clinical trial eligibility information from the National Cancer Institute's Physician Data Query (PDQ) database. We translated each free-text eligibility criterion into a machine executable statement using a derivation of the Arden Synta...

Ohno-machado, L.; Wang, S. J.; Mar, P.; Boxwala, A. A.

1999-01-01

371

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

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

Tappin David M

2012-07-01

372

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

373

Minority Enrollment in Parkinson’s Disease Clinical Trials  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Under-representation of minorities in clinical trials limits access to information relevant to all segments of the population. We assessed the enrollment of minority subjects with Parkinson’s disease (PD) into clinical trials. We searched PubMed for published studies of PD trials conducted in the US over the past 20 years and found that only 41 reported racial/ethnic participation (17%). In those trials reporting race/ethnicity, 8% of subjects were non-white, compared to 20% of the non-whit...

Schneider, Myra G.; Swearingen, Christopher J.; Shulman, Lisa M.; Ye, Jian; Baumgarten, Mona; Tilley, Barbara C.

2009-01-01

374

[Effect of the GCP Directive on academic drug trials  

DEFF Research Database (Denmark)

Since 2004, adherence to Good Clinical Practice has been mandatory for all clinical drug trials. This was new to the investigator-initiated trials. Our study showed no association between the implementation of the Directive and investigator or industry-initiated trials. However, a steady decline was observed over the entire period. Presumably, the introduction of GCP did not entail a decline because of the presence of GCP units at university hospitals. Thus, researchers can conduct clinical drug trials under the same regulations as drug companies Udgivelsesdato: 2008/8/11

Berendt, L.; Hakansson, C.

2008-01-01

375

Trial wave functions for High-Pressure Metallic Hydrogen  

CERN Document Server

Many body trial wave functions are the key ingredient for accurate Quantum Monte Carlo estimates of total electronic energies in many electron systems. In the Coupled Electron-Ion Monte Carlo method, the accuracy of the trial function must be conjugated with the efficiency of its evaluation. We report recent progress in trial wave functions for metallic hydrogen implemented in the Coupled Electron-Ion Monte Carlo method. We describe and characterize several types of trial functions of increasing complexity in the range of the coupling parameter $1.0 \\leq r_s \\leq1.55$. We report wave function comparisons for disordered protonic configurations and preliminary results for thermal averages.

Pierleoni, Carlo; Morales, Miguel A; Ceperley, David M; Holzmann, Markus

2007-01-01

376

Patent litigation settlement in Germany: Why parties settle during trial  

Digital Repository Infrastructure Vision for European Research (DRIVER)

This paper looks at the decision to settle patent litigation in Germany from a new angle by focusing on detailed data on within-trial actions and motivations by plain-tiff, defendant and the courts. Using a new dataset covering about 80% of all patent litigation cases in Germany between 2000 and 2008 we estimate the likelihood of within-trial settlement. We find that the within-trial settlement decision is to some degree driven by the proceedings that change the pre-trial setting of the negot...

Cremers, Katrin; Schliessler, Paula

2012-01-01

377

The Medical Research Council trials in adult acute lymphocytic leukemia.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Overall, the MRC Adult Leukaemia Trials have been successful, in that since the 1970s they have demonstrated a stepwise improvement in outcome. Examination of the survival curves shows the DFS rate at 5 years in UKALL Trial 1 of 5% rising to 38% in UKALL Trial XII (year 2000). Unfortunately, compared with children with ALL, these results in adults must be regarded as poor, because in the UKALL children's trials the EFS rate at 5 years for a child entered in the year 2000 is expected to be abo...

Durrant, Ij; Richards, Sm; Prentice, Hg; Goldstone, Ah

2000-01-01

378

Diagnostic randomized controlled trials: the final frontier  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Clinicians, patients, governments, third-party payers, and the public take for granted that diagnostic tests are accurate, safe and effective. However, we may be seriously misled if we are relying on robust study design to ensure accurate, safe, and effective diagnostic tests. Properly conducted, randomized controlled trials are the gold standard for assessing the effectiveness and safety of interventions, yet are rarely conducted in the assessment of diagnostic tests. Instead, diagnostic cohort studies are commonly performed to assess the characteristics of a diagnostic test including sensitivity and specificity. While diagnostic cohort studies can inform us about the relative accuracy of an experimental diagnostic intervention compared to a reference standard, they do not inform us about whether the differences in accuracy are clinically important, or the degree of clinical importance (in other words, the impact on patient outcomes. In this commentary we provide the advantages of the diagnostic randomized controlled trial and suggest a greater awareness and uptake in their conduct. Doing so will better ensure that patients are offered diagnostic procedures that will make a clinical difference.

Rodger Marc

2012-08-01

379

Phase 0 clinical trial- an overview  

Directory of Open Access Journals (Sweden)

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

Aanchal Satija

2011-07-01

380

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

 
 
 
 
381

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.  

Science.gov (United States)

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. PMID:21658262

Mbuagbaw, Lawrence; Thabane, Lehana; Ongolo-Zogo, Pierre; Lang, Trudie

2011-01-01

382

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

Directory of Open Access Journals (Sweden)

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

Molyneux Andrew J

2011-03-01

383

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

384

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

385

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

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

2013-01-01

386

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Background Previous research reviewed treatment success and whether the collective uncertainty principle is met in RCTs in the US National Cancer Institute portfolio. This paper classifies clinical trials funded by the UK HTA programme by results using the method applied to the US Cancer Institute trials, and compares the two portfolios. Methods Data on all completed randomised controlled trials funded by the HTA programme 1993-2008 were extracted. Each...

Dent Louise; Raftery James

2011-01-01

387

Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Background The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study. Methods We searched the 454,449 records on publications in The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, Issue 3, 2005 (CD-ROM version) for possible country of origin. We inspected a random sample of 906 records for informati...

Nikolova Dimitrinka; Gluud Christian

2007-01-01

388

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

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

2009-01-01

389

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

390

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Seyed Ali Reza Hosseini; Shadan Darbooy; Akram Salimi

2013-01-01

391

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

Science.gov (United States)

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

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

2014-07-01

392

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

Directory of Open Access Journals (Sweden)

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

Raftery James

2011-05-01

393

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.

394

Impact of Payment Policy on Enrollment and Retention in Clinical Trials | accrualnet.cancer.gov  

Science.gov (United States)

To avoid financial loss, clinical trial sites are analyzing a trial's financial impact and may decide not to initiate a trial if financial implications are negative. This abstract may be useful for those designing trials as well as institutions considering participating in a trial.

395

Review of clinical trials for mitochondrial disorders: 1997-2012.  

Science.gov (United States)

Over the last 15 years, some 16 open and controlled clinical trials for potential treatments of mitochondrial diseases have been reported or are in progress, and are summarized and reviewed herein. These include trials of administering dichloroacetate (an activator of pyruvate dehydrogenase complex), arginine or citrulline (precursors of nitric oxide), coenzyme Q10 (CoQ10; part of the electron transport chain and an antioxidant), idebenone (a synthetic analogue of CoQ10), EPI-743 (a novel oral potent 2-electron redox cycling agent), creatine (a precursor of phosphocreatine), combined administration (of creatine, ?-lipoate, and CoQ10), and exercise training (to increase muscle mitochondria). These trials have included patients with various mitochondrial disorders, a selected subcategory of mitochondrial disorders, or specific mitochondrial disorders (Leber hereditary optic neuropathy or mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes). The trial designs have varied from open-label/uncontrolled, open-label/controlled, or double-blind/placebo-controlled/crossover. Primary outcomes have ranged from single, clinically-relevant scores to multiple measures. Eight of these trials have been well-controlled, completed trials. Of these only 1 (treatment with creatine) showed a significant change in primary outcomes, but this was not reproduced in 2 subsequent trials with creatine with different patients. One trial (idebenone treatment of Leber hereditary optic neuropathy) did not show significant improvement in the primary outcome, but there was significant improvement in a subgroup of patients. Despite the paucity of benefits found so far, well-controlled clinical trials are essential building blocks in the continuing search for more effective treatment of mitochondrial disease, and current trials based on information gained from these prior experiences are in progress. Because of difficulties in recruiting sufficient mitochondrial disease patients and the relatively large expense of conducting such trials, advantageous strategies include crossover designs (where possible), multicenter collaboration, and the selection of very few, clinically relevant, primary outcomes. PMID:23361264

Kerr, Douglas S

2013-04-01

396

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

Science.gov (United States)

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

397

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

398

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

Directory of Open Access Journals (Sweden)

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

399

46 CFR 58.01-30 - Trial-trip observance.  

Science.gov (United States)

...2 2010-10-01 2010-10-01 false Trial-trip observance. 58.01-30 Section 58.01-30 Shipping COAST...SYSTEMS General Requirements § 58.01-30 Trial-trip observance. The operation of main and auxiliary engines,...

2010-10-01

400

The Technical Report of NAEP's 1990 Trial State Assessment Program.  

Science.gov (United States)

This report documents the design and data analysis procedures of the Trial State Assessment Program of the National Assessment of Educational Progress (NAEP). Today the NAEP is the only survey using advanced plausible values methodology that uses a multiple imputation procedure in a psychometric context. The 1990 Trial State Assessment collected…

Koffler, Stephen L.; And Others

 
 
 
 
401

A sequential procedure for monitoring clinical trials against historical controls.  

Science.gov (United States)

In this paper, we develop a sequential procedure to monitor clinical trials against historical controls. When there is a strong ethical concern about randomizing patients to existing treatment because biological and medical evidence suggests that the new treatment is potentially superior to the existing one, or when the enrollment is too limited for randomization of subjects into experimental and control groups, one can monitor the trial sequentially against historical controls if the historical data with required quality and sample size are available to form a valid reference for the trial. This design of trial is sometimes the only alternative to a randomized phase III trial design that is intended but not feasible in situations such as above. Monitoring this type of clinical trial leads to a statistical problem of comparing two population means in a situation in which data from one population are sequentially collected and compared with all data from the other population at each interim look. The proposed sequential procedures is based on the sequential conditional probability ratio test (SCPRT) by which the conclusion of the sequential test would be virtually the same as that arrived at by a non-sequential test based on all data at the planned end of the trial. We develop the sequential procedure by proposing a Brownian motion that emulates the test statistic, and then proposing an SCPRT that is adapted to the special properties of the trial. PMID:16900551

Xiong, Xiaoping; Tan, Ming; Boyett, James

2007-03-30

402

The dream and reality of histology agnostic cancer clinical trials.  

Science.gov (United States)

Emerging technologies and progress in data processing allowed for new insights on gene expression, genomics and epigenomics, and mechanisms of cancer genesis and progression. The development of new therapeutic strategies should therefore be triggered by the understanding of the underlying biology through sophisticated clinical trials. Therefore, the methodology and the design of cancer clinical trials as well as the methods of their implementation are under profound changes. Targeting specific pathways has open the hope of a more focused and personalized medicine which has the potential to bring more efficient and tailored treatments to patients. It has been questioned therefore whether clinical trials traditionally designed for specific tumor types could not re-visited towards trials gathering patients based on molecular features rather than pure pathology criteria. The complexity of the cancer biology being the result of so many different interactive mechanisms whether driving or not the process of cancer cells is an additional level of complexity to approach more inclusive clinical trial access. Nevertheless, a number of innovative solutions to address biological challenges across histologies have been initiated and the question of whether histology agnostic trials could be conceived is a logical next question. This paper questions the advantages and the limits of clinical trials performed across tumor types bearing similar selected molecular features and looks further into the feasibility of such histology agnostic trials. PMID:25349876

Lacombe, Denis; Burock, Susen; Bogaerts, Jan; Schoeffski, Patrick; Golfinopoulos, Vassilis; Stupp, Roger

2014-09-12

403

Ambulatory pessary trial unmasks occult stress urinary incontinence.  

Science.gov (United States)

Objective. We evaluated the use of a one-week ambulatory pessary trial in predicting patients' postoperative outcomes for occult stress incontinence. Methods. Patients with anterior vaginal wall prolapse were offered a pessary trial to predict response to reconstruction. We performed a retrospective review of 4 years of cases. All patients underwent a detailed evaluation including videourodynamics with and without pessary reduction. Results. Twenty-six patients completed the 1-week pessary trial. Ten (38%) women showing no evidence of stress urinary incontinence (SUI) underwent surgical repair of prolapse without anti-incontinence procedure. None of these patients had SUI postoperatively. Sixteen women (61%) had occult stress urinary incontinence on evaluation and underwent concurrent sling procedure. Three (19%) of these patients were identified by the pessary trial alone. Twenty-five of the 26 patients were without clinical stress incontinence at a mean follow up of 12 months (range 4-37 months). The pessary trial correctly predicted persistent urgency in six patients and persistent frequency in five. No patients with SUI or persistent voiding difficult were missed in a pessary trial. Conclusion. An ambulatory pessary trial is an effective, easy, and inexpensive method to approximate anatomic results achieved by surgery under real-life conditions. In our series, 20% of patients with occult SUI were identified by pessary trial alone. PMID:21949665

Chughtai, Bilal; Spettel, Sara; Kurman, Jonathan; De, Elise

2012-01-01

404

Process evaluation in randomised controlled trials of complex interventions  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Most randomised controlled trials focus on outcomes, not on the processes involved in implementing an intervention. Using an example from school based health promotion, this paper argues that including a process evaluation would improve the science of many randomised controlled trials

Oakley, A.; Strange, V.; Bonell, C.; Allen, E.; Stephenson, J.

2006-01-01

405

Future vision for the quality assurance of oncology clinical trials  

Directory of Open Access Journals (Sweden)

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

ThomasFitzGerald, MD

2013-03-01

406

Field Testing of the Discrete-Trials Teaching Evaluation Form  

Science.gov (United States)

We assessed the reliability and validity of the discrete-trials teaching evaluation form (DTTEF), a 21-item checklist for assessing instructors conducting discrete-trials teaching (DTT). In Phase 1, six consultants in an applied behavior analysis program for children with autism rated the 21 components of the DTTEF with a mean of 6.2 on a 7-point…

Jeanson, Brigitte; Thiessen, Carly; Thomson, Kendra; Vermeulen, Rhiannon; Martin, Garry L.; Yu, C. T.

2010-01-01

407

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.

408

Ethical issues posed by cluster randomized trials in health research  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics ...

Donner Allan; Brehaut Jamie C; Boruch Robert; Binik Ariella; Taljaard Monica; Grimshaw Jeremy M; Weijer Charles; Eccles Martin P; Gallo Antonio; McRae Andrew D; Saginur Raphael; Zwarenstein Merrick

2011-01-01

409

Review on clinical trials of targeted treatments in malignant mesothelioma  

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Jakobsen, Jan Nyrop; Sørensen, Jens Benn

2011-01-01

410

Review on clinical trials of targeted treatments in malignant mesothelioma  

DEFF Research Database (Denmark)

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

Jakobsen, Jan Nyrop; SØrensen, Jens Benn

2011-01-01

411

Fresh Market Tomato Cultivar Observation Trial for Northern Indiana, 2001  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Fresh market tomatoes were grown in an unreplicated trial at the Pinney-Purdue Agricultural Center in Wanatah, Indiana. The trial included 11 red beefsteak types, one yellow stuffing type, and one smallfruited yellow type. Yield and average fruit number are reported.

Maynard, Elizabeth

2001-01-01

412

The application of disease management to clinical trial designs.  

Science.gov (United States)

The utilization of disease management (DM) as a minimum standard of care is believed to facilitate pronounced benefits in overall patient outcome and cost management. Randomized clinical trials remain the gold standard evaluative tool in clinical medicine. However, the extent to which contemporary cardiovascular clinical trials incorporate DM components into their treatment or control arms is unknown. Our study is the first to evaluate the extent to which clinical trials incorporate DM as a minimum standard of care for both the intervention and control groups. In total, 386 clinical trials published in 3 leading medical journals between 2003 and 2006 were evaluated. For each study, elements related to DM care, as defined using the American Heart Association Taxonomy, were abstracted and characterized. Our results demonstrate that while the application of DM has increased over time, only 3.4% of the clinical trials examined incorporated all 8 DM elements (and only 11% of such trials incorporated 4 DM elements). A significant association was found between study year and the inclusion of more than 3 elements of DM (chi(2) = 10.10 (3); p = 0.018). In addition, associations were found between study objective and DM criteria, as well as between cohort type and domains described. Our study serves as a baseline reference for the tracking of DM within, and its application to, randomized clinical trials. Moreover, our results underscore the need for broader implementation and evaluation of DM as a minimum care standard within clinical trial research. PMID:19663623

Puterman, Jared; Alter, David A

2009-08-01

413

Psychiatry on trial: the Norway 2011 massacre.  

Science.gov (United States)

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

Roth, Walton T; Dager, Stephen R

2014-03-01

414

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

415

Diagnostic trials using CT scanning in urology  

Energy Technology Data Exchange (ETDEWEB)

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

Fujita, T. (Fujita Gakuen Univ., Toyoake, Aichi (Japan). School of Medicine)

1981-07-01

416

Parabolic Trough Solar Collector Initial Trials  

Directory of Open Access Journals (Sweden)

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

417

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

418

Diagnostic trials using CT scanning in urology  

International Nuclear Information System (INIS)

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

419

Clinical trial of DADDS in lepromatous leprosy.  

Science.gov (United States)

This presentation reports the results of a short clinical trial with DADDS in 23 patients of lepromatous leprosy. Injections of DADDS administered intramuscularly in a dose of 225 mg every 70 days produced clinical regression noticeable earliest at few week after the secondn injection. A fall in the morphological index from 5.0 to 0.6 was observed in patients who had received from 3 to 7 injections. Erythema nodosum leprosum was encountered in 7 cases, four of which had moderate to severe grades of reaction. It is advisible to discontinue further injection of DADDS if initial signs of ENL are noticed, which are likely to occur after the second injection. These ENL responded well to the usual line of antireaction treatment. DDS level in blood was found to be more than 10 ng/ml before the fresh administration of DADDS upto the seventh injection, representing the period of follow-up in this study. PMID:799207

Ganapati, R; Naik, S S; Shah, M H; Shirsat, L S; Gaitonde, B B

1976-07-01

420

Quality assurance in the CHART clinical trial  

International Nuclear Information System (INIS)

As part of the clinical trial of CHART (continuous hyperfractionated accelerated radiotherapy) a quality assurance programme was included. The technical part of this -- which is reported in this paper -- is a series of tests designed to check all aspects of treatment planning and delivery. The results of visits to the 13 participating centres -- and repeat visits to some of these centres -- are discussed. The main areas tested were as follows. The linear accelerator: mechanical, and optical, scales and indicators; radiation field size; flatness and symmetry. Dosimetry: output; wedge factor; beam energy; phantom measurements against a plan calculated by the centre. Simulator: mechanical, optical scales and indicators. The results show these centres work within the tolerances chosen for most parameters. Flatness, wedge factor and energy were areas of weakness in some centres. This must be partly the cause of the spread of phantom measurements which, after removal of variations in output, still range from -7 to +6% between calculated and measured values

 
 
 
 
421

Comparative leprosy vaccine trial in south India.  

Science.gov (United States)

This report provides results from a controlled, double blind, randomized, prophylactic leprosy vaccine trial conducted in South India. Four vaccines, viz BCG, BCG+ killed M. leprae, M.w and ICRC were studied in this trial in comparison with normal saline placebo. From about 3,00,000 people, 2,16,000 were found eligible for vaccination and among them, 1,71,400 volunteered to participate in the study. Intake for the study was completed in two and a half years from January 1991. There was no instance of serious toxicity or side effects subsequent to vaccination for which premature decoding was required. All the vaccine candidates were safe for human use. Decoding was done after the completion of the second resurvey in December 1998. Results for vaccine efficacy are based on examination of more than 70% of the original "vaccinated" cohort population, in both the first and the second resurveys. It was possible to assess the overall protective efficacy of the candidate vaccines against leprosy as such. Observed incidence rates were not sufficiently high to ascertain the protective efficacy of the candidate vaccines against progressive and serious forms of leprosy. BCG+ killed M. leprae provided 64% protection (CI 50.4-73.9), ICRC provided 65.5% protection (CI 48.0-77.0), M.w gave 25.7% protection (CI 1.9-43.8) and BCG gave 34.1% protection (CI 13.5-49.8). Protection observed with the ICRC vaccine and the combination vaccine (BCG+ killed M. leprae) meets the requirement of public health utility and these vaccines deserve further consideration for their ultimate applicability in leprosy prevention. PMID:10189587

Gupte, M D; Vallishayee, R S; Anantharaman, D S; Nagaraju, B; Sreevatsa; Balasubramanyam, S; de Britto, R L; Elango, N; Uthayakumaran, N; Mahalingam, V N; Lourdusamy, G; Ramalingam, A; Kannan, S; Arokiasamy, J

1998-01-01

422

Rationale for the tinnitus retraining therapy trial.  

Science.gov (United States)

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

Formby, Craig; Scherer, Roberta

2013-01-01

423

Controlled trial of aerobic exercise in hypertension.  

Science.gov (United States)

To determine the antihypertensive efficacy of aerobic exercise training in mild essential hypertension, a prospective randomized controlled trial was conducted comparing an aerobic exercise regimen to a placebo exercise regimen, with a crossover replication of the aerobic regimen in the placebo exercise group. The study took place in an outpatient research clinic in a university-affiliated Veterans Administration medical center. Twenty-seven men with untreated diastolic blood pressure (DBP) of 90-104 mm Hg were randomized to the two exercise regimens. Ten patients completed the aerobic regimen. Nine patients completed the control regimen, seven of whom subsequently entered and completed the aerobic regimen. The aerobic regimen consisted of walking, jogging, stationary bicycling, or any combination of these activities for 30 minutes, four times a week, at 65-80% maximal heart rate. The control regimen consisted of slow calisthenics and stretching for the same duration and frequency but maintaining less than 60% maximal heart rate. DBP decreased 9.6 +/- 4.7 mm Hg in the aerobic exercise group but increased 0.8 +/- 6.2 mm Hg in the placebo control exercise group (p = 0.02). Systolic blood pressure (SBP) decreased 6.4 +/- 9.1 mm Hg in the aerobic group and increased 0.9 +/- 9.7 mm Hg in the control group (p = 0.11). Subsequently, seven of the nine controls entered a treatment crossover and completed the aerobic regimen with significant reductions in both DBP (-6.1 +/- 3.2 mm Hg, p less than 0.01) and SBP (-8.1 +/- 5.7 mm Hg, p less than 0.01). BP changes were not associated with any significant changes in weight, body fat, urinary electrolytes, or resting heart rate. This randomized controlled trial provides evidence for the independent BP lowering effect of aerobic exercise in unmedicated mildly hypertensive men. PMID:2184945

Martin, J E; Dubbert, P M; Cushman, W C

1990-05-01

424

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

425

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

426

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

427

Automatic denoising of single-trial evoked potentials.  

Science.gov (United States)

We present an automatic denoising method based on the wavelet transform to obtain single trial evoked potentials. The method is based on the inter- and intra-scale variability of the wavelet coefficients and their deviations from baseline values. The performance of the method is tested with simulated event related potentials (ERPs) and with real visual and auditory ERPs. For the simulated data the presented method gives a significant improvement in the observation of single trial ERPs as well as in the estimation of their amplitudes and latencies, in comparison with a standard denoising technique (Donoho's thresholding) and in comparison with the noisy single trials. For the real data, the proposed method largely filters the spontaneous EEG activity, thus helping the identification of single trial visual and auditory ERPs. The proposed method provides a simple, automatic and fast tool that allows the study of single trial responses and their correlations with behavior. PMID:23142653

Ahmadi, Maryam; Quian Quiroga, Rodrigo

2013-02-01

428

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

Ebbing, Marta

2010-01-01

429

A concept for trial institutions focussing on randomised controlled trials in surgery  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Background Although considered the reference standard for generating valid scientific evidence of a treatment's benefits and harms, the number of Randomised Controlled Trials (RCT) comparing surgical techniques remains low. Much effort has been made in order to overcome methodological issues and improve quality of RCTs in surgery. To the present there has been, however, only little emphasis on development and maintenance of institutions for implementation of adequate...

Büchler Markus W; Kienle Peter; Wente Moritz N; Fischer Lars; Diener Markus K; Rahbari Nuh N; Seiler Christoph M

2008-01-01

430

Heparin-coated Wiktor stents in human coronary arteries (MENTOR trial). MENTOR Trial Investigators.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

The purpose of this study was to determine the feasibility, safety, and efficacy of elective stenting with heparin-coated Wiktor stents in patients with coronary artery disease. In experimental studies, heparin coating has been shown to prevent subacute thrombosis and restenosis. Recently, a new method of heparin coating was developed, resulting in a more stable and predictable heparin layer on stent devices. This trial constitutes the first in-human use of this coating procedure, applied on ...

Vrolix, M. C.; Legrand, Victor; Reiber, J. H.; Grollier, G.; Schalij, M. J.; Brunel, P.; Martinez-elbal, L.; Gomez-recio, M.; Bar, F. W.; Bertrand, M. E.; Colombo, A.; Brachman, J.

2000-01-01

431

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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

432

Facing the trial of internationalizing clinical trials to developing countries: some evidence from Mexico  

Digital Repository Infrastructure Vision for European Research (DRIVER)

In pursuit of innovation, developing countries play an increasingly relevant role for multinational pharmaceutical firms. Driven partly by cost considerations but also by some host country-specific scientific and technological factors, global drug companies increasingly relocate part of their drug development activities to those countries. In particular, expansion of clinical trials performed in some of the more advanced developing countries is notable over the last years. This paper critical...

Santiago-rodriguez, Fernando

2008-01-01

433

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

Digital Repository Infrastructure Vision for European Research (DRIVER)

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...

Callahan Christopher M; Boustani Malaz A; Schmid Arlene A; Austrom Mary G; Miller Douglas K; Gao Sujuan; Morris Carrie S; Vogel Mickey; Hendrie Hugh C

2012-01-01

434

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

435

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

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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

436

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

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...Industry: Early Clinical Trials With Live...Biotherapeutic Products: Chemistry, Manufacturing...Industry: Early Clinical Trials with Live...Biotherapeutic Products: Chemistry, Manufacturing...Industry: Early Clinical Trials with Live...Biotherapeutic Products: Chemistry,...

2010-10-14

437

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

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...Industry: Early Clinical Trials With Live...Biotherapeutic Products: Chemistry, Manufacturing...Industry: Early Clinical Trials With Live...Biotherapeutic Products: Chemistry, Manufacturing...Industry: Early Clinical Trials With Live...Biotherapeutic Products: Chemistry,...

2012-02-21

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