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1

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 (OFDMA)based 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; Kumbesan Sandrasegaran; Riyaj Basukala; Rachod Patachaianand; Toyoba Sohana Afrin

2011-01-01

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Women drivers' behavior in well-known versus less familiar locations.  

UK PubMed Central (United Kingdom)

INTRODUCTION: Through observations this study sought to examine the effects of road familiarity on driving performance. METHOD: Severe and minor traffic violations, dangerous behaviors, and speeding were assessed in well known and in less familiar locations. RESULTS: As compared to less known locations, drivers in well known locations performed more severe and minor violations, more dangerous behaviors, and they drove above the speed limit more often. DISCUSSION: The results are discussed in the context of Theory of Risk Homeostasis (later re-labeled as Target Risk Theory), the psychological effect of familiarity on driving performance, and the phenomenon of automatic driving. Presenting the risk of driving in familiar locations would assist to elevate safe driving.

Rosenbloom T; Perlman A; Shahar A

2007-01-01

3

The ability to point to well-known places in young and older adults.  

UK PubMed Central (United Kingdom)

BACKGROUND AND AIMS: A mental map of well-known places is organized according to a specific orientation where spatial information located in front of a person is more accessible than information located at the back (front-back effect). This study investigated age-related differences between young and older adults in building a mental map of well-known places when front and back pointing were required. METHODS: Thirty young (20-30 year olds) and 29 older (60-72 year olds) adults living in the same Italian town were compared in their ability to point to places inside their own town, and surrounding villages located in the front and back of their physical position in the city. A series of visuo-spatial tasks were also administered. RESULTS: Our results showed that young and older adults' performance in pointing to well-known places did not differ significantly, and that participants were affected by the pointing direction (i.e. forwards vs. backwards) and the type of place (i.e. in town vs. surrounding villages). It was easier for both young and older adults to point to places in town that were in front of them rather than behind them; there were no differences between pointing forwards or backwards in the surrounding villages. The influence of visuo-spatial abilities on pointing performance changed as a function of age: it was only in the older adults (not in the younger) that a spatial visualization task correlated with pointing performance. CONCLUSIONS: This study showed that older adults, despite their spatial cognitive decline shown by visuo-spatial tasks, retained the ability to build a mental representation of well-known places and were specifically sustained by spatial visualization ability.

Meneghetti C; Borella E; Fiore F; De Beni R

2013-05-01

4

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

UK PubMed Central (United Kingdom)

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

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

2005-02-01

5

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

UK PubMed Central (United Kingdom)

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

Getoff N

2013-04-01

6

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

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

2013-01-01

7

Zaprinast, a well-known cyclic guanosine monophosphate-specific phosphodiesterase inhibitor, is an agonist for GPR35.  

Science.gov (United States)

We found that zaprinast, a well-known cyclic guanosine monophosphate-specific phosphodiesterase inhibitor, acted as an agonist for a G protein-coupled receptor, GPR35. In our intracellular calcium mobilization assay, zaprinast activated rat GPR35 strongly (geometric mean EC(50) value of 16nM), whereas it activated human GPR35 moderately (geometric mean EC(50) value of 840nM). We also demonstrated that GPR35 acted as a Galpha(i/o)- and Galpha(16)-coupled receptor for zaprinast when heterologously expressed in human embryonic kidney 293 (HEK 293) cells. These findings will facilitate the research on GPR35 and the drug discovery of the GPR35 modulators. PMID:16934253

Taniguchi, Yasuhito; Tonai-Kachi, Hiroko; Shinjo, Katsuhiro

2006-08-17

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Zaprinast, a well-known cyclic guanosine monophosphate-specific phosphodiesterase inhibitor, is an agonist for GPR35.  

UK PubMed Central (United Kingdom)

We found that zaprinast, a well-known cyclic guanosine monophosphate-specific phosphodiesterase inhibitor, acted as an agonist for a G protein-coupled receptor, GPR35. In our intracellular calcium mobilization assay, zaprinast activated rat GPR35 strongly (geometric mean EC(50) value of 16nM), whereas it activated human GPR35 moderately (geometric mean EC(50) value of 840nM). We also demonstrated that GPR35 acted as a Galpha(i/o)- and Galpha(16)-coupled receptor for zaprinast when heterologously expressed in human embryonic kidney 293 (HEK 293) cells. These findings will facilitate the research on GPR35 and the drug discovery of the GPR35 modulators.

Taniguchi Y; Tonai-Kachi H; Shinjo K

2006-09-01

9

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

10

A review of age-related dehydroepiandrosterone decline and its association with well-known geriatric syndromes: is treatment beneficial?  

UK PubMed Central (United Kingdom)

Abstract Dehydroepiandrosterone (DHEA) and its sulfate ester are the most abundant steroids in humans. DHEA levels fall with age in men and women, reaching values sometimes as low as 10%-20% of those encountered in young individuals. This age-related decrease suggests an "adrenopause" phenomenon. Studies point toward several potential roles of DHEA, mainly through its hormonal end products, making this decline clinically relevant. Unfortunately, even if positive effects of DHEA on muscle, bone, cardiovascular disease, and sexual function seem rather robust, extremely few studies are large enough and/or long enough for conclusions regarding its effects on aging. Moreover, because it has been publically presented as a "fountain of youth" equivalent, over-the-counter preparations lacking pharmacokinetic and pharmacodynamic data are widely used worldwide. Conceptually, supplementing a pre-hormone is extremely interesting, because it would permit the human organism to adequately use it throughout long periods, increasing or decreasing end products according to his needs. Nevertheless, data on the safety profile of long-term DHEA supplementation are still lacking. In this article, we examine the potential relation between low DHEA levels and well-known age-related diseases, such as sarcopenia, osteoporosis, dementia, sexual disorders, and cardiovascular disease. We also review risks and benefits of existing protocols of DHEA supplementation.

Samaras N; Samaras D; Frangos E; Forster A; Philippe J

2013-08-01

11

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

UK PubMed Central (United Kingdom)

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

Carpentieri A; Ratner DM; Ghosh SK; Banerjee S; Bushkin GG; Cui J; Lubrano M; Steffen M; Costello CE; O'Keefe B; Robbins PW; Samuelson J

2010-11-01

12

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

UK PubMed Central (United Kingdom)

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 (ED(10) 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 ED(10) value was 0.835 µg/cm(2). The ED(10) 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 ED(10) 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.

Fischer LA; Menné T; Voelund A; Johansen JD

2011-06-01

13

Structure and luminescence properties of a well-known macrometallocyclic trinuclear Au(I) complex and its adduct with a perfluorinated fluorophore showing cooperative anisotropic supramolecular interactions.  

UK PubMed Central (United Kingdom)

The structure and luminescence properties of a well-known trinuclear Au(i) imidazolate complex are determined for the first time along with its interaction with the organic ? acid perfluoronaphthalene in the solid state and solution.

Elbjeirami O; Rashdan MD; Nesterov V; Rawashdeh-Omary MA

2010-10-01

14

Structure and luminescence properties of a well-known macrometallocyclic trinuclear Au(I) complex and its adduct with a perfluorinated fluorophore showing cooperative anisotropic supramolecular interactions.  

Science.gov (United States)

The structure and luminescence properties of a well-known trinuclear Au(i) imidazolate complex are determined for the first time along with its interaction with the organic ? acid perfluoronaphthalene in the solid state and solution. PMID:20852760

Elbjeirami, Oussama; Rashdan, Maher D; Nesterov, Vladimir; Rawashdeh-Omary, Manal A

2010-09-17

15

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; Daniel M. Fernandez-Mayoralas; Nuria Muñoz-Jareño; Victoria San Antonio-Arce

2007-01-01

16

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

Scientific Electronic Library Online (English)

Full Text Available 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 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 (more) 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 i (more) s 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.

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

2007-01-01

17

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

International Nuclear Information System (INIS)

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

1996-05-11

18

An analytical study on the existence of solitary wave and double layer solution of the well-known energy integral at M= Mc  

CERN Document Server

A general theory for the existence of solitary wave and double layer at M= Mc has been discussed, where Mc is the lower bound of the Mach number M, i.e., solitary wave and/or double layer solutions of the well-known energy integral start to exist for M> Mc. Ten important theorems have been proved to confirm the existence of solitary wave and double layer at M = Mc. If V({\\phi})({\\equiv}V(M,{\\phi})) denotes the Sagdeev potential with {\\phi} is the perturbed field or perturbed dependent variable associated with the specific problem, V(M,{\\phi}) is well defined as a real number for all M {\\in} \\mathcal{M} and for all {\\phi} {\\in} {\\Phi}, and V(M,0)=V'(M,0)=V"(Mc,0)=0, V'''(Mc,0)0), \\deltaV/\\deltaM 0 and for all {\\phi}({\\in} {\\Phi}) > 0 ({\\phi}({\\in}{\\Phi}) Mc, then there does not exist positive (negative) potential solitary wave at M= Mc. Result -3: It is not possible to have coexistence of both positive and negative potential solitary structures (including double layers) at M= Mc. Apart from the conditions of...

Das, Animesh

2011-01-01

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 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, eventualmente, uma intervenção cirúrgica urgente. Doença coronariana, síndrome aórtica aguda, cardiopatias congênitas, valvopatias e arritmias são sob este tó (more) pico 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 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 th (more) em, 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.

Yuan, Shi-Min; Jing, Hua

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; Hua Jing

2011-01-01

 
 
 
 
21

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

Scientific Electronic Library Online (English)

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

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

2008-03-01

22

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

Directory of Open Access Journals (Sweden)

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

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

2008-01-01

23

[Primula eczema--well-known and overlooked  

UK PubMed Central (United Kingdom)

A case of primula dermatitis presenting as recurrent hand eczema is reported. In spite of a positive patch test reaction to primin, the diagnosis was not made until three years later, when the patient was shown a colour photo of Primula obconica and admitted contact with the plant. Since few patients are able to supply correct information of exposure to this primula species, it is recommended to show colour photos of the plant as a routine procedure in cases where there are positive patch test reactions to primin.

Paulsen E

1994-02-01

24

A ''well-known'' advanced oxidation reaction revisited. The photo-Fenton-oxidation of 4-chlorophenol and 2,4-dichloro-phenol in a homogeneous and a heterogeneous system  

Energy Technology Data Exchange (ETDEWEB)

The oxidative degradation of 4-chlorophenol and 2,4-dichlorophenol by the thermal and photochemically enhanced Fenton reactions has served as a model reaction for the comparison of different reaction conditions. The process of dechlorination of the chlorinated phenols is generally monitored by the determination of the chloride anion by ion chromatography. Some authors even proposed the measurement of the released chloride as a convenient measure for the advancement of Fenton reactions of reaction mixtures occurring in the environment. Therefore, we revisited these ''well-known'' reactions and combined mechanistic investigations of the formed chemical intermediates by GC-mass spectroscopy with the determinations of thorough chloride balances. This mechanistic tool was further employed for the comparison of the homogeneous and the heterogeneous photochemically enhanced Fenton degradation of 4-chlorophenol and 2,4-dichlorophenol. A mixture of ferric sulphate and hydrogen peroxide was employed for the homogeneous Fenton reactions, whereas the heterogeneous Fenton experiments were performed using an iron(III)-exchanged zeolite Y photocatalyst. Different reaction pathways for the homogenous and heterogeneous (photo)Fenton reactions and especially for the oxidative degradation of 4-chlorophenol and 2,4-dichlorophenol were observed. Consequences for the comparison of different operating conditions of (photo)Fenton processes are discussed. (orig.)

Rios-Enriquez, M.A.; Bossmann, S.H.; Oliveros, E.; Shahin, N.; Braun, A.M. [Lehrstuhl fuer Umweltmesstechnik, am Engler-Bunte Inst. der Univ. Karlsruhe (Germany); Duran-de-Bazua, C. [Facultad de Quimica, Univ. Nacional Autonoma de Mexico (Mexico)

2003-07-01

25

Solar p--p reaction: a well known process  

International Nuclear Information System (INIS)

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

1978-01-07

26

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

DEFF Research Database (Denmark)

In a recent open pilot trial, R-salbutamol sulphate, a well-known molecule with anti-inflammatory effects, was tested successfully on patients with therapy-resistant discoid lupus erythematosus (DLE).

Jemec, Gregor; Ullman, Susanne

2009-01-01

27

Clinical Trials  

Medline Plus

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. ...

28

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

UK PubMed Central (United Kingdom)

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

García Fernández FP; López Casanova P; Pancorbo Hidalgo PL; Verdú Soriano J

2009-01-01

29

Not well known, used little and needed: Canadian chaplains' experiences of published spiritual assessment tools.  

Science.gov (United States)

What are Canadian chaplains' experiences of published assessment tools? Utilizing a quantitative and qualitative methodology with multiple investigators and theoretical triangulation, this article reports the results of a survey of chaplains in the Canadian Association for Pastoral Practice and Education (CAPPE) and interview results of 15 chaplains in three focus groups. Findings indicated that published spiritual assessment tools are not well know, used little, criticized for being reductionistic and not fitting the clinical situation. Participants noted, however, that spiritual assessment is needed for spiritual care. Thirty percent reported the development of their own tools (not published) and three published tools were mentioned by 50% and more. Discussion, limitations of the research, and suggestions for education, practice, and future research are offered. PMID:15943149

O'Connor, Thomas St James; O'Neill, Kathleen; Van Staalduinen, Grace; Meakes, Elizabeth; Penner, Carol; Davis, Katherine

30

Not well known, used little and needed: Canadian chaplains' experiences of published spiritual assessment tools.  

UK PubMed Central (United Kingdom)

What are Canadian chaplains' experiences of published assessment tools? Utilizing a quantitative and qualitative methodology with multiple investigators and theoretical triangulation, this article reports the results of a survey of chaplains in the Canadian Association for Pastoral Practice and Education (CAPPE) and interview results of 15 chaplains in three focus groups. Findings indicated that published spiritual assessment tools are not well know, used little, criticized for being reductionistic and not fitting the clinical situation. Participants noted, however, that spiritual assessment is needed for spiritual care. Thirty percent reported the development of their own tools (not published) and three published tools were mentioned by 50% and more. Discussion, limitations of the research, and suggestions for education, practice, and future research are offered.

O'Connor TS; O'Neill K; Van Staalduinen G; Meakes E; Penner C; Davis K

2005-01-01

31

Keratosis follicularis squamosa (Dohi): a follicular keratotic disorder well known in Japan.  

UK PubMed Central (United Kingdom)

Keratosis follicularis squamosa (KFS) is a keratinizing disorder, which is well recognized in Japan but rarely reported in other countries. KFS is characterized by asymptomatic small scaly patches with a follicular plug that is scattered on the trunk and thighs. It is easily diagnosed by its characteristic appearance that was originally described in Japanese as "lotus leaves on the water". We report a typical case of KFS and review the mainly Japanese literature. We conclude that KFS is a distinct clinical entity of unknown origin. World-wide recognition of this disease should further clarify the prevalence and pathogenesis of this skin condition.

Shimizu S; Shimizu T; Tateishi Y; Shimizu H

2001-05-01

32

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; Xiaofeng Liao; Aqeel Ur Rehman,; Afshan Azam; M.I. Abdullah

2012-01-01

33

New indication for therapeutic potential of an old well-known drug (propranolol) for multiple myeloma.  

UK PubMed Central (United Kingdom)

PURPOSE: Propranolol, a non-selective ?-adrenergic receptor blocker, has been used for the treatment of the patients with hypertension for more than 50 years. There are several in vitro and in vivo evidences that ?-adrenergic receptor antagonists inhibit proliferation and angiogenesis and also increase apoptosis in breast, skin, and colon cancers. The aim of this study was to investigate the cytotoxic and apoptotic effects of propranolol and the genes involved in propranolol-induced apoptosis in multiple myeloma cells. METHODS: Time-dependent antiproliferation and apoptotic effects of propranolol were subsequently determined by MTT cell proliferation assay, changes in caspase-3 activity, loss of mitochondrial membrane potential (MMP), and also the localization of phosphatidylserine in the plasma membrane. Changes in expression levels of NF-?B pathway were examined by qRT-PCR array. RESULTS: IC50 values of propranolol on U266 cells were calculated as 141, 100, and 75 ?M after 24-, 48-, and 72-h propranolol exposure, respectively. There were significant increases in caspase-3 activity, loss of MMP, and increases in apoptotic cell population in response to propranolol in U266 cells in a time- and dose-dependent manner. There were increases in expression levels of BCL10, TRAF family members, interleukins, TLR1-4, TNFRSF10B, NF-?B, and the inhibitors of NF-?B genes, and significant decreases in expression levels of Bcl-2 in response to propranolol treatment were observed. CONCLUSION: These results revealed that propranolol has antiproliferative and apoptotic effects on multiple myeloma cells. Being supported with in vivo analyses, propranolol can be a good and economical way to treat multiple myeloma patients.

Kozanoglu I; Yandim MK; Cincin ZB; Ozdogu H; Cakmakoglu B; Baran Y

2013-02-01

34

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; Hamidreza Asgari Dehabadi

2012-01-01

35

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

Directory of Open Access Journals (Sweden)

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

William A. Paradise; Benjamin J. Vesper; Ajay Goel; Joshua D. Waltonen; Kenneth W. Altman; G. Kenneth Haines III; James A. Radosevich

2010-01-01

36

Conservative phylogenetic occurrence of ortho-chlorobenzoate dioxygenase by well-known chlorobenzoate degrading bacteria.  

Czech Academy of Sciences Publication Activity Database

. Prague : Institute of Chemical Technology Prague, 2001. s. -.[Innovative Approaches to the On-Site Assessment and Remediation of Contaminated Sites. 24.05.2001-02.06.2001, Prague]Výzkumný zám?r: CEZ:AV0Z5020903Kód oboru RIV: EB - Genetika a molekulární biologie

Prouza, MarekG; Totevová, Sonja; Pavl?, Lenka

37

Correlations between transmural gastric potential difference and a well-known mathematical model.  

UK PubMed Central (United Kingdom)

After administration of several gastric irritants, time curves of the transmural gastric potential difference (GPD) were obtained. An attempt was made at fitting a mathematical function to these curves in order to facilitate and improve their evaluation. The Bateman function proved to be a useful description tool. In pharmacokinetics, this function is used amongst others for describing concentration profiles. For a total of 74 GPD curves, biexponential functions were fitted by the RIP-technique. The following irritants were administered: acetylsalicylic acid (ASA; 1000 mg, 500 mg, 250 mg), theophylline (480 mg, 350 mg), indomethacine (50 mg), and ethanol (20 ml, 40 v/v). The following results were obtained: The Bateman function is suitable for describing the observed biphasic time course of gastric potential difference, which includes lesion and restitution ("two compartment model"); correlation was high (r = 0.9). The curve parameters computed by this technique--area AUB, mean time, mean drop--are comparable to those obtained by pragmatic procedures (trapezoid rule). In particular, there is a distinct dosage-response relation between parameters correlated to irritating potency and the administered dose of ASA. Due to considerable interindividual variation of the parameters, ultimate assessment of their relationships to specific irritants could not be done.

Kaerner HJ; Venitz J; Lücker PW

1984-10-01

38

Clinical Trials  

Medline Plus

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

39

Clinical Trials  

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Full Text Available ... You Be Interested in a Clinical Trial? People volunteer to take part in clinical trials for many ... to benefit from a new treatment. Often people volunteer because they want to contribute to a research ...

40

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 ...

 
 
 
 
41

Clinical Trials  

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Full Text Available ... the fastest way to find new treatments that work in people. You may be interested in or ... and how well it may or may not work. Why are Clinical Trials Important? Researchers use clinical ...

42

Clinical Trials  

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

43

Participating in Clinical Trials  

Medline Plus

Full Text Available ... Z > Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks and Benefits ... of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study ...

44

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 b...

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

45

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

International Nuclear Information System (INIS)

The quality and the power of human activities affect the external environment in different ways that can be measured and evaluated by means of several approaches and indicators. While the scientific community has been publishing several proposals for sustainable development indicators, there is still no consensus regarding the best approach to the use of these indicators and their reliability to measure sustainability. It is important, therefore, to question the effectiveness of sustainable development indicators in an effort to continue in the search for sustainability. This paper compares the results obtained with emergy accounting with five global Sustainability Metrics (SMs) proposed in the literature to verify if metrics are communicating coherent and similar information to guide decision makers towards sustainable development. Results obtained using emergy indices are discussed with the aid of emergy ternary diagrams. Metrics are confronted with emergy results, and the degree of variability among them is analyzed using a correlation matrix created for the Mercosur nations. The contrast of results clearly shows that metrics arrive at different interpretations about the sustainability of the nations studied, but also that some metrics may be grouped and used more prudently. Mercosur is presented as a case study to highlight and explain the discrepancies and similarities among Sustainability Metrics, and to expose the extent of emergy accounting.

1212-01-00

46

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

Science.gov (United States)

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

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

2013-07-22

47

Complementary notes on a `well-known' marine heterotrichous ciliate, Folliculinopsis producta (Wright, 1859) Frauré-Fremiet, 1936 (Protozoa, ciliophora)  

Science.gov (United States)

The living morphology and infraciliature of a heterotrichous ciliate, Folliculinopsis producta (Wright, 1859) Frauré-Fremiet, 1936, which was collected from the north coast of China, were investigated by in vivo observation and protargol impregnation techniques. As a new contribution, a redescription is presented: large Folliculinopsis of green to dark green in color, 800 1500µmn in size; two peristomial lobes of approximately equal size, 300 400µm in length; adoral zone of membranelles containing about 1000 membranelles, lying along lobe margins and exhibiting two circles within buccal cavity; 50 70 somatic kineties in mid-body; macronucleus miniliform, consisting of about 20 beads; lorica smooth, vase-shaped, (300 500)µm × (90 130)µm in size, with 5 12 spiral ridges on neck tube; marine habitat.

Ji, Daode; Lin, Xiaofeng; Song, Weibo

2004-04-01

48

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

49

Hepatitis C: Clinical Trials  

Science.gov (United States)

... trials to make this decision. Testing drugs for hepatitis C is very important, and clinical trials are a ... All medicines that you can now get for hepatitis C were first tested in clinical trials. How do ...

50

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.

51

Participating in Clinical Trials  

Medline Plus

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

52

Participating in Clinical Trials  

Medline Plus

Full Text Available ... as surgical techniques, psychiatric therapy, or radiotherapy. Click image for description Scientists usually do years of experiments ... join this type of trial. Prevention Trials Click image for description In prevention trials, researchers study ways ...

53

Erectile dysfunction is frequent in systemic sclerosis and associated with severe disease: a study of the EULAR Scleroderma Trial and Research group  

Digital Repository Infrastructure Vision for European Research (DRIVER)

INTRODUCTION: Erectile dysfunction (ED) is common in men with systemic sclerosis (SSc) but the demographics, risk factors and treatment coverage for ED are not well known. METHOD: This study was carried out prospectively in the multinational EULAR Scleroderma Trial and Research database by amending ...

Foocharoen, Chingching; Tyndall, Alan; Hachulla, Eric; Rosato, Edoardo; Allanore, Yannick; Farge-Bancel, Dominique

54

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 ... and side effects, and to find the correct drug dosage. A Phase II trial is similar to ...

55

Participating in Clinical Trials  

Medline Plus

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

56

Clinical Trial Information Management  

Science.gov (United States)

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

57

Alzheimer's Disease Clinical Trials Database  

Science.gov (United States)

... National Alzheimer's Project Act (NAPA) About ADEAR Find Alzheimer's Disease and Related Clinical Trials To find clinical ... 4380. See all clinical trials currently recruiting Featured Alzheimer's Disease Clinical Trials Systolic Blood Pressure Intervention Trial: ...

58

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 Related Pages

59

Thyroid Cancer - Featured Clinical Trials  

Science.gov (United States)

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

60

Alzheimer's Association TrialMatch  

Science.gov (United States)

... 8:30 p.m. CT Monday-Friday) About Alzheimer's Association TrialMatch ® Overview We need your help How ... TrialMatch Where do trial listings come from? About Alzheimer's Association TrialMatch Overview Welcome to Alzheimer's Association TrialMatch®, ...

 
 
 
 
61

Nutrition Intervention Trials - Linxian  

Science.gov (United States)

Dysplasia Trial. The dysplasia trial, conducted in three communes (Yaocun, Rencun, and Donggang) in northern Linxian, enrolled 40- to 69-year-old adults who had evidence of esophageal dysplasia on a balloon cytology examination but had no history of malignancy.

62

Clinical Trials 101  

Science.gov (United States)

Clinical Trials 101 You will need Adobe Flash Player 8 or later and JavaScript enabled to view this video. You can view the movie here Video of webinar for public health professionals introducing clinical trials and explaining key concepts, June 2011.

63

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... care expected while in a trial, and the cost of the trial. The following questions might be ... a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes. Diagnostic trials ...

64

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... happens during a clinical trial? The clinical trial process depends on the kind of trial being conducted. ... What is informed consent? Informed consent is the process of learning the key facts about a clinical ...

65

Update on TROG trials  

International Nuclear Information System (INIS)

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

2001-10-04

66

Inept media trials of clinical trials.  

UK PubMed Central (United Kingdom)

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

Ramamurthy NV

2012-04-01

67

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

Directory of Open Access Journals (Sweden)

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

Jim Rogers

2010-01-01

68

Clinical Trials Management  

Science.gov (United States)

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

69

Participating in Clinical Trials  

Medline Plus

Full Text Available ... prevent a disease. A clinical trial may also compare experimental treatments or tests to those already available ... treatments, their risks, and how well they work compare existing therapies to decide which one, or a ...

70

Participating in Clinical Trials  

Medline Plus

Full Text Available ... more sleep, keeping mentally active, or eating nutritious foods, can prevent a problem taking certain medicines, or ... many more people are tested. If the U.S. Food and Drug Administration agrees that the trial results ...

71

Participating in Clinical Trials  

Medline Plus

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

72

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

International Nuclear Information System (INIS)

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

1990-01-01

73

COPD exacerbations admitted to intensive care unit. Organization, mortality, and noninvasive or invasive mechanical ventilation strategies: are they sufficiently well known?  

Directory of Open Access Journals (Sweden)

Full Text Available Antonio M EsquinasIntensive Care Unit, Hospital Morales Meseguer, Murcia, SpainWe read with interest the survival analysis of chronic obstructive pulmonary disease (COPD) patients who are admitted to critical care units with exacerbation, conducted in Saudi Arabia by Alaithan et al.1 This study makes an important contribution on the real practice of intensive care units (ICUs). The authors, in the overall results, provided some great information similar in some aspects to previous epidemiologic surveys where a low level of consciousness on admission, need for endotracheal intubation (ETI), being a current smoker, cardiopulmonary arrest, tracheostomy, and development of acute renal failure are associated with higher ICU and hospital mortality. Although, study design showed some limitations with respect to interpretation predictors of mortality, there are aspects that differ compared to previous studies in this area that could be taken into account for clinical and practical implications.View original paper by Alaithan and colleagues.

Esquinas AM

2013-01-01

74

Cystone, a Well-known Herbal Formulation Improves Renal Function in Rats with Acute Renal Failure (ARF) Induced by Glycerol Intoxication  

Directory of Open Access Journals (Sweden)

Full Text Available The present study was aimed to evaluate the beneficial effect of Cystone syrup in an experimental animal model of renal failure in rats. Cystone syrup was evaluated against glycerol-induced acute renal failure (ARF) in rats, biochemical parameters, kidney weight and histopathological evaluation was performed to conclude the beneficial effect of Cystone syrup. Administration of single dose of 50% v/v glycerol (8ml/kg.i.m) caused severe renal dysfunction associated with significant increase in markers of renal function such as serum urea (p<0.01), creatinine (p<0.01), blood urea nitrogen (BUN) (p<0.01), decrease in the Creatinine clearance (Ccr) (p<0.01) and increase in kidney weight to body weight ratio (p<0.01)compared to control group. These changes were in accordance with the histopathological findings showing severe tubular necrosis, degeneration and moderate luminal cast formation. Pre-treatment withCystone (5 ml/kg, p.o) for seven days, alleviated the glycerol induced renal dysfunction significantly by maintaining serum urea (p<0.01), creatinine (p<0.05), BUN (p<0.01) and kidney weight to body weight ratio (p<0.05), improved the creatinine clearance (p<0.05) compared to untreated glycerol control. In addition, histopathology of Cystone (5 ml/kg, p.o) treated group showed mild to moderate tubular necrosis and degeneration. The findings of the present study demonstrates the usefulness of Cystone syrup inreversing the biochemical/ structural markers of renal dysfunction observed in experimental model of renal failure in rats.

Rajesh S; Mohamed Rafiq; Viswanatha Gl; Mohammed Azeemuddin M; Uday Kumar Vk; Patki Ps

2012-01-01

75

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

76

[April 22nd, 2005 law of patients' rights and end of life: not a well-known law due to poor communication].  

UK PubMed Central (United Kingdom)

The law number 2005-370 of April 22, 2005, or "Leonetti law", is a very important law for patients' rights and management of the end of life. In spite of its importance, it seems to remain largely unknown to ordinary citizen and even health professionals. In this study, we evaluated the knowledge of this law among general practitioners from Isere (France), and looked at the best communication mode to channel information about the law. The analysis of the content of the 581 answers out of 1050 sent questionnaires (55,3%) confirms the poor knowledge about the law. General practitioners went through a self-evaluation about their knowledge: they estimate they had a rather low knowledge, with a median at 2 over 10. 23% had never heard about the law. Paradoxically, the objective evaluation of their knowledge gives more positive results (below 56,3% per question). However, their mistakes deal with important points of the law: traceability of decisions, trusted person, value of advanced directives, and collegial medical procedure. In addition to accompanying the patient and his family, the role of the general practitioner in respect to this law lies more specifically in helping patients who want to draft early directives or to designate a trusted person. In primary care, tough decisions concerning withholding or withdrawal of treatments should be made collaboratively.

de Bazelaire C; Laval G; Aubry R

2009-06-01

77

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

Science.gov (United States)

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

2010-01-01

78

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

UK PubMed Central (United Kingdom)

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.

Singer SR; Amit-Kohn M; Weiss S; Rosenblum J; Maoz G; Samuels N; Lukasiewicz E; Freedman L; Paltiel O; Itzchaki M; Niska M; Oberbaum M

2010-01-01

79

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

Singer Shepherd R; Amit-Kohn Michal; Weiss Samuel; Rosenblum Jonathan; Maoz Guy; Samuels Noah; Lukasiewicz Esther; Freedman Laurence; Paltiel Ora; Itzchaki Menachem; Niska Meir; Oberbaum Menachem

2010-01-01

80

Beaufort Sea dispersant trial  

Energy Technology Data Exchange (ETDEWEB)

In August 1986, an offshore dispersant trial was conducted in the Beaufort Sea. The purpose of this trial was to determine the effectiveness of aerially applied dispersants under arctic conditions, to evaluate the efficacy of multi-hit dispersant application, and to define the logistic and cost considerations for conducting a full-scale dispersant operation in the Beaufort Sea. All of the objectives outlined in the trial protocol were achieved as planned. In general, the results indicated that it is logistically possible to conduct an aerial dispersant operation in the Arctic and that there is some indication (mostly visual and photographic) that dispersants produce the desired effect. In spite of this, there is still no clear evidence that dispersants are as effective as they need to be for environmental protection purposes. The trial showed that some mechanism that creates a phenomenon known as 'emulsion balls' interferes with the dispersion process and results in an overall reduction in dispersant effectiveness. These 'balls' formed on the surface of the water in each of the sprayed slicks and tended to confuse the interpretation of the infrared imagery, which was the prime method used in determining dispersant effectiveness. Until the uncertainties created by the presence of these balls can be resolved, the use of remote sensing as a technique for determining dispersant effectiveness should be supported with an adequate ground truthing program. 21 refs., 35 figs., 6 tabs.

Swiss, J.J.; Vanderkooy, N.

1988-01-01

 
 
 
 
81

Basic Introduction to Clinical Trials  

Medline Plus

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

82

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... conducted. The clinical trial team includes doctors and nurses as well other health care professionals. They check ... someone decide whether to participate, the doctors and nurses involved in the trial explain the details of ...

83

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... in a clinical trial? All clinical trials have guidelines about who can participate. The factors that allow ... participant is a non-English speaking person, federal guidelines require a version of the consent form be ...

84

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... a clinical trial? A clinical trial (also called clinical research) is a research study using human volunteers designed ... a website that provides regularly updated information about clinical research in human volunteers -- www.clinicaltrials.gov , where you ...

85

Basic Introduction to Clinical Trials  

Medline Plus

Full Text Available ... agrees to participate in a clinical trial that compares an experimental medicine or device with a standard ... risks, side effects, and benefits in the study compare with my current treatment? How might this trial ...

86

Basic Introduction to Clinical Trials  

Medline Plus

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

87

Basic Introduction to Clinical Trials  

Medline Plus

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

88

Basic Introduction to Clinical Trials  

Medline Plus

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

89

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 ...

90

Basic Introduction to Clinical Trials  

Medline Plus

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

91

Funding oncology clinical trials: are cooperative group trials sustainable?  

UK PubMed Central (United Kingdom)

PURPOSE: Many oncology clinical trials departments (CTDs) are in serious fiscal deficit and their sustainability is in jeopardy. This study investigates whether the payment models used to fund industry versus cooperative group trials contribute to the fiscal deficit of a CTD. METHODS: We examined the lifetime costs of all cooperative group and industry trials activated in the CTD of a cancer center between 2007 and 2011. A trial's lifetime is defined as being from the date the first patient was accrued until the last patient's actual or projected final follow-up visit. For each trial, we calculated the lifetime monthly net income, which was defined as monthly revenue minus monthly costs. Data sources included study protocols, trial budgets, and accrual data. RESULTS: Of the 97 trials analyzed, 64 (66%) were cooperative group trials. The pattern of lifetime net income for cooperative group trials has a positive peak during patient accrual followed by a negative trough during follow-up. In contrast, the pattern for industry trials resembled an "l" shape. The patterns reflect the differing payment models: upfront lump-sum payments (cooperative group) versus milestone payments (industry). CONCLUSION: The negative trough in the lifetime net income of a cooperative group trial occurs because follow-up costs are typically not funded or are underfunded. CTDs accrue more patients in new trials to offset that deficit. The CTD uses revenue from accrual to existing trials to cross-subsidize past trials in follow-up. As the number of patients on follow-up increases, the fiscal deficit grows larger each year, perpetuating the cycle.

Seow HY; Whelan P; Levine MN; Cowan K; Lysakowski B; Kowaleski B; Snider A; Xu RY; Arnold A

2012-05-01

92

A randomised controlled trial of nurse-managed trial conclusion following early phase cancer trial participation.  

UK PubMed Central (United Kingdom)

The effect of a nurse-managed intervention, for early phase cancer trial participants at trial conclusion, on psychosocial outcomes was evaluated at two cancer centres in the Midlands, England using a randomised controlled trial. It involved 117 patients who were participating in an early phase cancer clinical trial. It was a nurse-managed trial exit, which included a trial exit interview, trial feedback information leaflet and telephone follow-up compared with standard care at trial conclusion. Psychological distress at 1 week and 4-6 weeks post-trial conclusion, patient's knowledge and understanding and patient's satisfaction were assessed. The results showed there was no significant difference between the two groups regarding scores for anxiety and depression at time one and time two. There is some suggestion that the intervention reduced anxiety from trial conclusion to follow-up (P=0.27). Patients in both groups felt they had contributed to cancer research through trial participation. However, intervention patients were more likely to feel that they knew how the trial was going (P<0.001), knew how other people in the trial were doing (P=0.001), had all the feedback they needed about the trial they took part in (P<0.01) and knew how they would be followed up (P=0.02). Patient satisfaction with the intervention was high (median score=4.5 where 5 is greatest satisfaction). In conclusion, nurse-managed trial conclusion led to positive outcomes for patients who had recently completed a clinical trial.

Cox K; Wilson E; Arthur A; Elkan R; Armstrong S

2005-07-01

93

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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

Bayés M; Rabasseda X; Prous JR

2007-01-01

94

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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

Bayes M; Rabasseda X; Prous JR

2006-04-01

95

Carotid endarterectomy: trials and tribulations.  

Science.gov (United States)

Since its introduction 40 years ago, the value of carotid endarterectomy has been controversial. In the early 1980s, several clinical trials were initiated to determine the efficacy of this operation in patients with carotid stenoses who were either symptomatic or asymptomatic for retinal or hemispheric ischemia. In 1991, interim results were published for the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the European Carotid Surgery Trial (ECST), both reporting efficacy for surgery in patients with symptomatic carotid artery stenosis of greater than 70%. Subgroup analyses revealed variable risk groups. The Veterans Administration (VA) Symptomatic Trial (Cooperative Studies Program 309 of the Department of Veterans Affairs) terminated early because of these results and its findings were consistent with the results of the larger trials. NASCET and ECST continue for symptomatic patients with carotid stenoses between 30% and 69%. The results of three trials in asymptomatic patients, the Mayo asymptomatic trial, the Carotid Artery Stenosis with Asymptomatic Narrowing: Operation Versus Aspirin trial, and the VA Asymptomatic Trial (Cooperative Studies Protocol 167 of the Department of Veterans Affairs), have been reported. None showed a statistically significant benefit for surgery in the prevention of stroke or death. However, none was sufficiently large to exclude such a benefit. The large Asymptomatic Carotid Atherosclerosis Study is in progress. Differences in the results and design of these trials are discussed as are restrictions in the applicability of their results. PMID:8285592

Easton, J D; Wilterdink, J L

1994-01-01

96

The detection of adverse events in randomized clinical trials: can we really say new medicines are safe?  

UK PubMed Central (United Kingdom)

BACKGROUND: While it is well known that randomized controlled trials (RCTs) are usually designed with sufficient sample size and power to detect the efficacy but not safety of a medicine, the extent to which RCTs quantify safety has not been well ascertained. PURPOSE: The aim of this study was to assess the safety data available for five commonly prescribed medicines at the time of marketing. METHODS: Published RCTs for five medicines risperidone, sertraline, donepezil, strontium ranelate and tramadol extended release were identified. All adverse events (AEs) in the trials were independently extracted by two clinical researchers. Using the sample size in the trials, the power to detect the observed difference in AEs rates between the treatment and placebo groups was calculated. A power of 80% or more was deemed adequate to detect AEs; studies with power of < 80% were deemed insufficiently powered to detect AEs. RESULTS: 12 RCTs were identified. Six trials were insufficiently powered to detect any of the potential AEs reported. Of the 150 evaluated AEs, the trials were insufficiently powered to detect 81% (122/150) of the AEs reported. For the adverse events that were detected with adequate powered clinical trials, only 53% (10/19) of potentially very common AEs (?10%) and 17% (18/106) of potentially common AEs (1%-<10%) were identified. CONCLUSION: Trials are insufficiently powered to detect the majority of adverse events that are reported in clinical trials, even for common adverse events. Observations other than primary efficacy endpoints such as AEs that are not prespecified with adequate power should be treated as hypothesis generating only and not justification of evidence. Claims of safety based on trial evidence not designed for the safety endpoint are often premature.

Wahab IA; Pratt NL; Kalisch LM; Roughead EE

2013-04-01

97

Gateways to clinical trials.  

Science.gov (United States)

Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables 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: 131-I-Chlorotoxin, 423557; Abatacept, Ad.Egr.TNF.11D, Adalimumab, AE-941, Ambrisentan, AMR-001, Anacetrapib, Anakinra, Aripiprazole, Atazanavir sulfate; BAY-639044, Bazedoxifene acetate, Belimumab, Bevacizumab, Bortezomib, Botulinum toxin type B, Brivaracetam, Bucindolol hydrochloride; Carfilzomib, Carisbamate, CCX-282, CD20Bi, Ceftobiprole, Certolizumab pegol, CF-101, Cinacalcet hydrochloride, Cypher; Darifenacin hydrobromide, Degarelix acetate, Denosumab, Desvenlafaxine succinate, Dexlansoprazole, Dexverapamil, Drotrecogin alfa (activated), Duloxetine hydrochloride, Dutasteride; Efalizumab, EPs-7630, Escitalopram oxalate, Etoricoxib; Fluticasone furoate, Fondaparinux sodium, Fospropofol disodium; Hexadecyloxypropyl-cidofovir, HIV gp120/NefTat/AS02A, HPV-6/11/16/18; INCB-18424, Incyclinide, Inhalable human insulin, Insulin detemir; KNS-760704, KW-0761; Lacosamide, Lenalidomide, Levetiracetam, Licofelone, Lidocaine/prilocaine; mAb 216, MEDI-528, Men ACWY, Meningococcal C-CRM197 vaccine, Methylnaltrexone bromide; Nemifitide ditriflutate, Nicotine conjugate vaccine, Nilotinib hydrochloride monohydrate; Octaparin; Parathyroid hormone (human recombinant), Pegaptanib octasodium, Pitrakinra, Prasterone, Pregabalin; Ranelic acid distrontium salt, Rasagiline mesilate, Retigabine, Rimonabant, RTS,S/AS02D; Sarcosine, Sitaxentan sodium, Solifenacin succinate, Sunitinib malate; Taranabant, Taxus, Teduglutide, Teriparatide, Ticagrelor, Travoprost, TRU-015; USlipristal acetate, Urocortin 2; Vardenafil hydrochloride hydrate; YM-155, Yttrium 90 (90Y) ibritumomab tiuxetan; Zanolimumab, Zoledronic acid monohydrate, Zotarolimus, Zotarolimus-eluting stent. PMID:18560631

Moral, M A; Tomillero, A

2008-03-01

98

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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: 131-I-Chlorotoxin, 423557; Abatacept, Ad.Egr.TNF.11D, Adalimumab, AE-941, Ambrisentan, AMR-001, Anacetrapib, Anakinra, Aripiprazole, Atazanavir sulfate; BAY-639044, Bazedoxifene acetate, Belimumab, Bevacizumab, Bortezomib, Botulinum toxin type B, Brivaracetam, Bucindolol hydrochloride; Carfilzomib, Carisbamate, CCX-282, CD20Bi, Ceftobiprole, Certolizumab pegol, CF-101, Cinacalcet hydrochloride, Cypher; Darifenacin hydrobromide, Degarelix acetate, Denosumab, Desvenlafaxine succinate, Dexlansoprazole, Dexverapamil, Drotrecogin alfa (activated), Duloxetine hydrochloride, Dutasteride; Efalizumab, EPs-7630, Escitalopram oxalate, Etoricoxib; Fluticasone furoate, Fondaparinux sodium, Fospropofol disodium; Hexadecyloxypropyl-cidofovir, HIV gp120/NefTat/AS02A, HPV-6/11/16/18; INCB-18424, Incyclinide, Inhalable human insulin, Insulin detemir; KNS-760704, KW-0761; Lacosamide, Lenalidomide, Levetiracetam, Licofelone, Lidocaine/prilocaine; mAb 216, MEDI-528, Men ACWY, Meningococcal C-CRM197 vaccine, Methylnaltrexone bromide; Nemifitide ditriflutate, Nicotine conjugate vaccine, Nilotinib hydrochloride monohydrate; Octaparin; Parathyroid hormone (human recombinant), Pegaptanib octasodium, Pitrakinra, Prasterone, Pregabalin; Ranelic acid distrontium salt, Rasagiline mesilate, Retigabine, Rimonabant, RTS,S/AS02D; Sarcosine, Sitaxentan sodium, Solifenacin succinate, Sunitinib malate; Taranabant, Taxus, Teduglutide, Teriparatide, Ticagrelor, Travoprost, TRU-015; USlipristal acetate, Urocortin 2; Vardenafil hydrochloride hydrate; YM-155, Yttrium 90 (90Y) ibritumomab tiuxetan; Zanolimumab, Zoledronic acid monohydrate, Zotarolimus, Zotarolimus-eluting stent.

Moral MA; Tomillero A

2008-03-01

99

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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.

Tomillero A; Moral MA

2010-11-01

100

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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.

Bayes M; Rabasseda X; Prous JR

2006-09-01

 
 
 
 
101

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: Abiraterone acetate, Ad5CMV-p53, adefovir dipivoxil, AE-941, ambrisentan, aripiprazole, atomoxetine hydrochloride, atrasentan; BCH-10618, bimatoprost, BMS-184476, BMS-275183, BMS-387032, botulinum toxin type B, BR-1, BR96-Doxorubicin; Capravirine, caspofungin acetate, cinacalcet hydrochloride; Darbepoetin alfa, desloratadine, dextrin sulfate, DJ-927, duloxetine hydrochloride; Elacridar, emtricitabine, eplerenone, ertapenem sodium, escitalopram oxalate, ESP-24217, etoricoxib, exenatide, ezetimibe; Ferumoxtran-10, fondaparinux sodium, fosamprenavir calcium; GS-7904L, GW-5634; HMN-214, human insulin; IC-14, imatinib mesylate, indiplon, insulin glargine, insulinotropin, iseganan hydrochloride; Lanthanum carbonate, L-Arginine hydrochloride, LEA29Y, lenalidomide, LE-SN38, lestaurtinib, L-MDAM, lometrexol, lopinavir, lopinavir/ritonavir; Magnesium sulfate, maraviroc, mepolizumab, metreleptin, milataxel, MNA-715, morphine hydrochloride; Nesiritide, neutrophil-inhibitory factor, NK-911; Olanzapine/fluoxetine hydrochloride, olmesartan medoxomil, omalizumab, ortataxel, oxycodone hydrochloride/ibuprofen; Panitumumab, patupilone, PC-515, PD-MAGE-3 Vaccine, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ ribavirin, pemetrexed disodium, pimecrolimus, prasugrel, pregabalin, PRO-2000; Rosuvastatin calcium, RPR-113090; sabarubicin hydrochloride, safinamide mesilate, SB-715992, sitaxsentan sodium, soblidotin, synthadotin; Tadalafil, taltobulin, temsirolimus, tenofovir disoproxil fumarate, tenofovir disoproxil fumarate/emtricitabine, testosterone gel, tigecycline, tipranavir, tirapazamine, trabectedin, travoprost; UCN-01; Vardenafil hydrochloride hydrate; XB-947; Yttrium 90 (90Y) ibritumomab tiuxetan. PMID:15605126

Bayés, M; Rabasseda, X; Prous, J R

2004-10-01

102

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: ABT-510, adalimumab, alefacept, ambrisentan, aminolevulinic acid methyl ester, armodafinil, aselizumab, asenapine maleate, azelnidipine; Bevacizumab, bexarotene, bimosiamose, biphasic insulin aspart, bortezomib, bosentan, BQ-123; C340, cannabidiol, caspofungin acetate, CC-4047, certolizumab pegol, cetuximab, ciclesonide, cilansetron, Cypher; Dabigatran etexilate, darbepoetin alfa, darifenacin hydrobromide, desloratadine, dexosome vaccine (melanoma), dimethyl fumarate, dronabinol/cannabidiol, drospirenone, drospirenone/estradiol, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Efalizumab, eglumetad hydrate, emoxipin hydrochloride, eplerenone, erlotinib hydrochloride, escitalopram oxalate, etonogestrel/ethinylestradiol; Garenoxacin mesilate, gamma-hydroxybutyrate sodium, gefitinib; H5N1 pandemic influenza vaccine, human growth hormone-(177-191), human insulin; Indacaterol, INKP-100, INKP-102, insulin glargine, i.v. gamma-globulin; KLH; Lapatinib, L-arginine hydrochloride, lasofoxifene tartrate, levocetirizine, licochalcone A, LMI vaccine, lomefloxacin, lubiprostone, lumiracoxib; Miglustat, mycograb; Natalizumab, NCX-4016, nortopixantrone hydrochloride; Olmesartan medoxomil, omalizumab, oral insulin, OrM3; Parathyroid hormone (human recombinant), parecoxib sodium, PCK-3145, PEG-filgrastim, peginterferon alfa-2a, pemetrexed disodium, pexelizumab, photochlor, pimecrolimus, pneumococcal 7-valent conjugate vaccine, polyphenon E; R-126638, R-411, resveratrol, roflumilast, RS-86, ruboxistaurin mesilate hydrate, rupatadine fumarate; Sipuleucel-T, somatropin, St. John's Wort extract; Tadalafil, Taxus, telbivudine, telithromycin, temsirolimus, teriparatide, teverelix, tigecycline, tiotropium bromide, tolterodine, tolvaptan, treprostinil sodium, typhoid vaccine; Vardenafil hydrochloride hydrate, vildagliptin, voriconazole; Ximelagatran; Zanolimumab, zileuton.

Bayés M; Rabasseda X; Prous JR

2006-01-01

103

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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:(R)-Flurbiprofen, 90Yttrium-DOTA-huJ591; ABT-510, ACP-103, Ad5-FGF4, adalimumab, ademetionine, AG-7352, alemtuzumab, Amb a 1 ISS-DNA, anakinra, apaziquone, aprepitant, aripiprazole, atazanavir sulfate; BAL-8557, bevacizumab, BMS-188797, bortezomib, bosentan, brivudine; Calcipotriol/betamethasone dipropionate, cannabidiol, caspofungin acetate, catumaxomab, CERE-120, cetuximab, ciclesonide, cilomilast, cizolirtine citrate, Cypher, cystemustine; Dalbavancin, darifenacin hydrobromide, dasatinib, deferasirox, denosumab, desmoteplase, dihydrexidine, dimethyl fumarate, dutasteride, DW-166HC; Eculizumab, enfuvirtide, entecavir, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, eszopiclone, etoricoxib, everolimus; Fallypride, febuxostat, fenretinide, fesoterodine, fingolimod hydrochloride; Gabapentin enacarbil, gefitinib; hMaxi-K, human papillomavirus vaccine, HYAL-CT1101; Imatinib mesylate, indiplon, inolimomab, ISAtx-247; J591; Lacosamide, landiolol, lasofoxifene tartrate, lestaurtinib, lidocaine/prilocaine, linezolid, lixivaptan, lonafarnib, lopinavir, lopinavir/ritonavir, lumiracoxib; Natalizumab, nesiritide; OC-108, omalizumab, onercept, OSC; Palifermin, palonosetron hydrochloride, parathyroid hormone (human recombinant), parecoxib sodium, PD-MAGE-3 vaccine, PEG-filgrastim, peginterferon alfa-2a, peginterferon alfa-2b, pegsunercept, pelitinib, pitavastatin calcium, plerixafor hydrochloride, posaconazole, prasterone sulfate, pregabalin; Ramelteon, ranelic acid distrontium salt, rasburicase, rosuvastatin calcium, rotigotine, RSD-1235, rufinamide, rupatadine fumarate; Sarizotan hydrochloride, SHL-749, sirolimus-eluting stent, solifenacin succinate, sunitinib malate; Tadalafil, talampanel, tasidotin hydrochloride, Taxus, tegaserod maleate, telavancin hydrochloride, tenofovir disoproxil fumarate, tiotropium bromide, tocilizumab, tositumomab, treprostinil sodium, tridolgosir hydrochloride, TTS-CD3; Ularitide; Valdecoxib, Val-Tyr sardine peptidase, vardenafil hydrochloride hydrate, voriconazole; Yttrium (90Y) edotreotide, Yttrium 90 (90Y) ibritumomab tiuxetan; Zileuton, zucapsaicin.

Bayes M; Rabasseda X; Prous JR

2006-07-01

104

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

105

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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.

Tomillero A; Moral MA

2008-10-01

106

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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

Tomillero A; Moral MA

2009-09-01

107

Gateways to clinical trials.  

Science.gov (United States)

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

Bayés, M; Rabasseda, X; Prous, J R

2005-04-01

108

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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

Bayés M; Rabasseda X; Prous JR

2005-04-01

109

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

110

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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.

Tomillero A; Moral MA

2010-12-01

111

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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

Bayés M; Rabasseda X; Prous JR

2007-12-01

112

Gateways to clinical trials.  

Science.gov (United States)

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

Bayés, M; Rabasseda, X; Prous, J R

2007-12-01

113

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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: Abiraterone acetate, Ad5CMV-p53, adefovir dipivoxil, AE-941, ambrisentan, aripiprazole, atomoxetine hydrochloride, atrasentan; BCH-10618, bimatoprost, BMS-184476, BMS-275183, BMS-387032, botulinum toxin type B, BR-1, BR96-Doxorubicin; Capravirine, caspofungin acetate, cinacalcet hydrochloride; Darbepoetin alfa, desloratadine, dextrin sulfate, DJ-927, duloxetine hydrochloride; Elacridar, emtricitabine, eplerenone, ertapenem sodium, escitalopram oxalate, ESP-24217, etoricoxib, exenatide, ezetimibe; Ferumoxtran-10, fondaparinux sodium, fosamprenavir calcium; GS-7904L, GW-5634; HMN-214, human insulin; IC-14, imatinib mesylate, indiplon, insulin glargine, insulinotropin, iseganan hydrochloride; Lanthanum carbonate, L-Arginine hydrochloride, LEA29Y, lenalidomide, LE-SN38, lestaurtinib, L-MDAM, lometrexol, lopinavir, lopinavir/ritonavir; Magnesium sulfate, maraviroc, mepolizumab, metreleptin, milataxel, MNA-715, morphine hydrochloride; Nesiritide, neutrophil-inhibitory factor, NK-911; Olanzapine/fluoxetine hydrochloride, olmesartan medoxomil, omalizumab, ortataxel, oxycodone hydrochloride/ibuprofen; Panitumumab, patupilone, PC-515, PD-MAGE-3 Vaccine, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ ribavirin, pemetrexed disodium, pimecrolimus, prasugrel, pregabalin, PRO-2000; Rosuvastatin calcium, RPR-113090; sabarubicin hydrochloride, safinamide mesilate, SB-715992, sitaxsentan sodium, soblidotin, synthadotin; Tadalafil, taltobulin, temsirolimus, tenofovir disoproxil fumarate, tenofovir disoproxil fumarate/emtricitabine, testosterone gel, tigecycline, tipranavir, tirapazamine, trabectedin, travoprost; UCN-01; Vardenafil hydrochloride hydrate; XB-947; Yttrium 90 (90Y) ibritumomab tiuxetan.

Bayés M; Rabasseda X; Prous JR

2004-10-01

114

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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:(R)-Flurbiprofen, 90Yttrium-DOTA-huJ591; ABT-510, ACP-103, Ad5-FGF4, adalimumab, ademetionine, AG-7352, alemtuzumab, Amb a 1 ISS-DNA, anakinra, apaziquone, aprepitant, aripiprazole, atazanavir sulfate; BAL-8557, bevacizumab, BMS-188797, bortezomib, bosentan, brivudine; Calcipotriol/betamethasone dipropionate, cannabidiol, caspofungin acetate, catumaxomab, CERE-120, cetuximab, ciclesonide, cilomilast, cizolirtine citrate, Cypher, cystemustine; Dalbavancin, darifenacin hydrobromide, dasatinib, deferasirox, denosumab, desmoteplase, dihydrexidine, dimethyl fumarate, dutasteride, DW-166HC; Eculizumab, enfuvirtide, entecavir, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, eszopiclone, etoricoxib, everolimus; Fallypride, febuxostat, fenretinide, fesoterodine, fingolimod hydrochloride; Gabapentin enacarbil, gefitinib; hMaxi-K, human papillomavirus vaccine, HYAL-CT1101; Imatinib mesylate, indiplon, inolimomab, ISAtx-247; J591; Lacosamide, landiolol, lasofoxifene tartrate, lestaurtinib, lidocaine/prilocaine, linezolid, lixivaptan, lonafarnib, lopinavir, lopinavir/ritonavir, lumiracoxib; Natalizumab, nesiritide; OC-108, omalizumab, onercept, OSC; Palifermin, palonosetron hydrochloride, parathyroid hormone (human recombinant), parecoxib sodium, PD-MAGE-3 vaccine, PEG-filgrastim, peginterferon alfa-2a, peginterferon alfa-2b, pegsunercept, pelitinib, pitavastatin calcium, plerixafor hydrochloride, posaconazole, prasterone sulfate, pregabalin; Ramelteon, ranelic acid distrontium salt, rasburicase, rosuvastatin calcium, rotigotine, RSD-1235, rufinamide, rupatadine fumarate; Sarizotan hydrochloride, SHL-749, sirolimus-eluting stent, solifenacin succinate, sunitinib malate; Tadalafil, talampanel, tasidotin hydrochloride, Taxus, tegaserod maleate, telavancin hydrochloride, tenofovir disoproxil fumarate, tiotropium bromide, tocilizumab, tositumomab, treprostinil sodium, tridolgosir hydrochloride, TTS-CD3; Ularitide; Valdecoxib, Val-Tyr sardine peptidase, vardenafil hydrochloride hydrate, voriconazole; Yttrium (90Y) edotreotide, Yttrium 90 (90Y) ibritumomab tiuxetan; Zileuton, zucapsaicin. PMID:16894408

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115

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

Gateways to Clinical Trials is a guide to the most recent clinical trials reported 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:[188Re]-HDD; A-179578, adalimumab, AK-602, albumin interferon alfa, alfimeprase, amelubant, anakinra, anti-CD2 MAb, APD-356, aripiprazole, atvogen; Bimatoprost, bimosiamose, BLP-25, brivaracetam; Caspofungin acetate, cilansetron, CMV vaccine (bivalent), conivaptan hydrochloride, Cypher; Darbepoetin alfa, darifenacin hydrobromide, D-D4FC, decitabine, dnaJP1, doranidazole, dronedarone hydrochloride; Efalizumab, efaproxiral sodium, emtricitabine, Endeavor, entecavir, erlotinib hydrochloride, escitalopram oxalate, etoricoxib, etravirine, ezetimibe; Fampridine, fenretinide, ferumoxtran-10, forodesine hydrochloride; Gantacurium chloride, gemi-floxacin mesilate, Glyminox, GW-501516; HBV-ISS, hepavir B, human insulin, HuMax-CD20, hyaluronic acid, HyCAMP; Icatibant, IDEA-070, IGN-311, imatinib mesylate, insulin detemir, insulin glargine, insulin glulisine; Lapatinib, lasofoxifene tartrate, LB-80380, liarozole fumarate, liposome encapsulated doxorubicin, lumiracoxib, LY-570310; MC-1, melatonin, merimepodib, metanicotine, midostaurin; Natalizumab, nicotine conjugate vaccine, NYVAC-HIV C; Patupilone, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pelitinib, Peru-15, pexelizumab, PHP, pimecrolimus, prednisolone sodium metasulfobenzoate; Recombinant alfa1-antitrypsin (AAT), retigabine, rHA influenza vaccine, rifalazil, rofecoxib, rosiglitazone maleate/Metformin hydrochloride, rostaporfin, rosuvastatin calcium, rubitecan; Selenite sodium, semilente insulin, SMP-797, sorafenib; Talampanel, tenofovir disoproxil fumarate, TER-199, tiotropium bromide, torcetrapib, treprostinil sodium, TTA; ValboroPro, valdecoxib, val-mCyd, valtorcitabine dihydrochloride: XP-828L.

Bayés M; Rabasseda X; Prous JR

2005-01-01

116

The trials of ECT.  

UK PubMed Central (United Kingdom)

Since its introduction in 1934, electroconvulsive therapy has been subjected to a large number of clinical trials of varying methodological sophistication. Although doubts continue to be expressed about the efficacy of ECT, there is a remarkable degree of unanimity in the findings of trials published over a period of 50 years: improvement rates in depression of 70-80 per cent, compared with 20-30 per cent in untreated controls. The principal caveat is that ECT is not a ubiquitous treatment, even in the field of depression, and only patients with endogenous illnesses, whether unipolar or bipolar, can be expected to respond. Even among these, ECT cannot be expected to prevent the relapses in an illness whose underlying course is episodic. The published studies leave little doubt that ECT is statistically more effective than any of the antidepressant drugs, although the relative difference in outcome between the 2 forms of therapy is small, and drugs are to be preferred in mild or moderate cases. However, ECT is an effective and rapidly acting treatment for severe depressive illness, and the rapidity of the response makes its early use desirable in patients at risk of suicide, and those showing marked retardation, agitation and weight loss.

Kiloh LG

1985-01-01

117

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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

Bayés M; Rabasseda X; Prous JR

2003-12-01

118

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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: ABT-510, ABX-EGF, acetyldinaline, ACIDFORM, acyline, afeletecan hydrochloride, anecortave acetate, apolizumab, l-arginine hydrochloride, asimadoline, atazanavir sufate, atlizumab; BMS-181176, BMS-188667; CAB-175, carnosine, CDP-870, CEP-701, CEP-7055, CGC-1072, ChimeriVax-JE, ciclesonide, cilomilast, clofarabine, combretastatin A-4 phosphate, cryptophycin 52; Duloxetine hydrochloride; E-5564, eculizumab, elcometrine, emtricitabine, ENO, epratuzumab, eszopiclone, everolimus; Fampridine, flurbiprofen nitroxybutyl ester; Garenoxacin mesilate, gestodene, GI-181771, gimatecan, gomiliximab; Halofuginone hydrobromide, hGH, hLM609; ICA-17043, IL-1 receptor type II, IMC-1C11, iodine (I131) tositumomab, irofulven, ISAtx-247; J591; L-778123, lanthanum carbonate Lasofoxifene tartrate, LDP-02, LE-AON, leteprinim potassium, lintuzumab, liraglutide, lubiprostone, lumiracoxib, lurtotecan, LY-450108, LY-451395; MAb G250, magnesium sulfate, MDX-210, melatonin, 2-methoxy-estradiol, monophosphoryl lipid A; NM-3, nolpitantium besilate; Ocinaplon, olpadronic acid sodium salt, oral heparin; Palonosetron hydrochloride, pemetrexed disodium, PI-88, picoplatin, plevitrexed, polyphenon E, pramlintide acetate, pregabalin, prinomastat, pyrazoloacridine; Resiniferatoxin, rhEndostatin, roxifiban acetate; S-18886, siplizumab, sitaxsentan sodium, solifenacin succinate, SU-11248, SU-6668; Talampanel, TAPgen, testosterone transdermal gel, trabectedin; VEGF-2 gene therapy, visilizumab; ZD-6416, ZD-6474.

Bayés M; Rabasseda X; Prous JR

2003-07-01

119

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abetimus sodium, ademetionine, agalsidase alfa, agalsidase beta, alemtuzumab, alfimeprase, AMG-162, androgel, anidulafungin, antigastrin therapeutic vaccine, aripiprazole, atomoxetine hydrochloride; Bazedoxifene acetate, bevacizumab, bosentan; Caldaret hydrate, canfosfamide hydrochloride, choriogonadotropin alfa, ciclesonide, combretastatin A-4 phosphate, CY-2301; Darbepoetin alfa, darifenacin hydrobromide, decitabine, degarelix acetate, duloxetine hydrochloride; ED-71, enclomiphene citrate, eplerenone, epratuzumab, escitalopram oxalate, eszopiclone, ezetimibe; Fingolimod hydrochloride, FP-1096; HMR-3339A, HSV-TK/GCV gene therapy, human insulin, HuOKT3gamma1(Ala234-Ala235); Idursulfase, imatinib mesylate, indiplon, InnoVax C insulin glargine, insulin glulisine, irofulven; Labetuzumab, lacosamide, lanthanum carbonate, LyphoDerm, Lyprinol; Magnesium sulfate, metelimumab, methylphenidate hydrochloride; Natalizumab, NO-aspirin; OROS(R); PC-515, pegaptanib sodium, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, peptide YY3-36, posaconazole, pregabalin, PT-141, pyridoxamine; R-744, ramelteon, ranelic acid distrontium salt, rebimastat, repinotan hydrochloride, rhC1, rhGAD65, rosiglitazone maleate/metformin hydrochloride; Sardomozide, solifenacin succinate; Tadalafil, taxus, telavancin, telithromycin, tenofovir disoproxil fumarate, teriparatide, testosterone transdermal patch, tetomilast, tirapazamine, torcetrapib; Valspodar, vardenafil hydrochloride hydrate, vildagliptin; Yttrium Y90 epratuzumab; Ziprasidone hydrochloride.

Bayés M; Rabasseda X; Prous JR

2004-12-01

120

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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: 166Ho-DOTMP 5A8; A-179578, abetimus sodium, adefovir dipivoxil, AGI-1067, AIDSVAX gp120 B/B, AK-602, alefacept alemtuzumab, aliskiren fumarate, ALVAC vCP1433, ALVAC vCP1452, anecortave acetate, arzoxifene hydrochloride, atazanavir sulfate, atlizumab, avasimibe; Binodenoson, BMS-488043; Choriogonadotropin alfa, ciclesonide, COL-1621, CVT-3146, CVT-E002, Cypher; Daptomycin, darbepoetin alfa, darunavir, D-D4FC, deferasirox, desloratadine, desmoteplase, duloxetine hydrochloride, DX-9065a; E-5564, efalizumab, emfilermin, emivirine, emtricitabine, enfuvirtide, estradiol acetate, ezetimibe; Frovatriptan; Gallium maltolate, gefitinib; HIV-1 Immunogen, human insulin; Iguratimod, IL-4/IL-13 Trap, imatinib mesylate, inhaled insulin, insulin glargine, irofulven, ISS-1018, ivabradine hydrochloride; Lutropin alfa; Melatonin; Nesiritide; O6-Benzylguanine, omapatrilat, oritavancin, ospemifene; Parecoxib sodium, peginterferon alfa-2a, pexelizumab, pimecrolimus, pirfenidone, pramlintide acetate, prasterone sulfate PT-141; Rasburicase, razaxaban hydrochloride, recombinant malaria vaccine, rhBMP-2/ACS, roflumilast, rosiglitazone maleate/metformin hydrochloride, rotavirus vaccine; SCH-D, sitaxsentan sodium, solifenacin succinate; Targinine hydrochloride, taxus, TER-199, tramadol hydrochloride/acetaminophen; Valdecoxib, valganciclovir hydrochloride, vatalanib succinate, VEG Trap(R1R2); Ximelagatran; Yttrium Y90 Epratuzumab.

Bayes M; Rabasseda X; Prous JR

2004-05-01

 
 
 
 
121

Japan nuclear ship sea trial  

International Nuclear Information System (INIS)

[en] The sea trial of the first Japan nuclear Ship 'MUTSU' was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author)

1992-01-01

122

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: (-)-Epigallocatechin gallate; ACP-103, Ad.Egr.TNF.11 D, adalimumab, AF-IL 12, AIDSVAX gp120 B/B, alefacept, alemtuzumab, a-Galactosylceramide, ALVAC vCP 1452, alvimopan hydrate, alvocidib hydrochloride, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, anakinra, anidulafungin, antarelix, aprepitant, aripiprazole, arsenic sulfide, asoprisnil, atazanavir sulfate, atomoxetine hydrochloride; Bevacizumab, bimatoprost, BMS-184476, bortezomib, bosentan, botulinum toxin type B, BrachySil, brivudine; Caffeine, calcipotriol/betamethasone dipropionate, cannabidiol, capsaicin for injection, caspofungin acetate, CC-4047, cetuximab, CGP-36742, clofazimine, CpG-7909, Cypher; Darbepoetin alfa, dextromethorphan/quinidine sulfate, dimethylfumarate, dronabinol/cannabidiol, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecogramostim, efalizumab, eletriptan, emtricitabine, enfuvirtide, eplerenone, esomeprazole magnesium, estradiol acetate, eszopiclone, etoricoxib, exenatide, ezetimibe, ezetimibe/simvastatin; Fampridine, fondaparinux sodium, fosamprenavir calcium; Gefitinib, GPI-0100; hA 20, HTU-PA, human insulin, HuOKT 3 gamma 1(Ala 234-Ala 235), hyaluronic acid; Icatibant, imatinib mesylate, Indiplon, INKP-100, INKP-102, iodine (I131) tositumomab, istradefylline, IV gamma-globulin, ivabradine hydrochloride, ixabepilone; Lacosamide, landiolol, lanthanum carbonate, lasofoxifene tartrate, LB-80380, lenalidomide, lidocaine/tetracaine, linezolid, liposomal doxorubicin, liposomal vincristine sulfate, lopinavir, lopinavir/ritonavir, lumiracoxib, lurtotecan; Maribavir, morphine glucuronide, MVA-5 T 4; NBI-56418, NCX-4016, nesiritide, nicotine conjugate vaccine, NSC-330507; Oglufanide, omalizumab, oxipurinol; Palifermin, palonosetron hydrochloride, parecoxib sodium, PEG-filgrastim, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, PEGylated interferon alfacon-1, perospirone hydrochloride, pimecrolimus, pixantrone maleate, plerixafor hydrochloride, PowderJect lidocaine, pradefovir mesylate, prasterone, pregabalin, Prostvac VF, PT-141, PTC-124, pyridoxamine; QS-21, quercetin; R-126638, R-411, ralfinamide, rasagiline mesilate, rF-PSA, RG-2077, rhThrombin, rimonabant hydrochloride, rofecoxib, rosuvastatin calcium, rotigotine hydrochloride, rV-PSA; S-18886, S-303, seocalcitol, SGN-40, sitaxsentan sodium, SPP-301, St. John's Wort extract; Tadalafil, taxus, telithromycin, tenatoprazole, tenofovir disoproxil fumarate, testosterone MDTS, testosterone transdermal patch, tgAAC-09, TH-9507, thioacetazone, tipifarnib, TQ-1011, trabectedin, travoprost, trimethoprim; Valdecoxib, valganciclovir hydrochloride, valopicitabine, voriconazole; Xcellerated T cells. PMID:16179960

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

123

The quality of alcohol treatment research: an examination of influential controlled trials and development of a quality rating system.  

UK PubMed Central (United Kingdom)

BACKGROUND: The importance of evidence-based practice has stimulated interest in the methodology of clinical trials. Various weaknesses of evaluation research in the alcohol field have been indicated previously. This study set out to develop a comprehensive system for the assessment of the methodological quality of outcome research for treatment of alcohol misuse and to apply the system to well-known trials in the area. METHODOLOGY: A sample of the most highly cited controlled trials of interventions for alcohol misuse was selected using the Science Citation Index. Thirty methodological criteria were formulated and a scoring system devised. Two raters applied this system to the sample of trials. Reliability testing was performed and used to refine the criteria. RESULTS: Inter-rater reliability of the overall quality score was initially 0.85 and 0.92 after review and re-rating. Internal consistency was also high (0.87). Quality score correlated with year of publication. Certain areas of methodology were poorly addressed in the sample, including specification of main outcomes, documentation of recruitment and selection procedures, testing of blinding, analysis of withdrawals and reporting of results. DISCUSSION: The methodology of this sample of trials was frequently deficient in ways which might bias results or compromise generalizability. It is recommended that the system of quality assessment described here is used to evaluate existing research and to inform the design of future studies.

Moncrieff J; Drummond DC

1998-06-01

124

Electromagnetic Radiation: On Trial  

Science.gov (United States)

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

2007-05-16

125

Gateways to clinical trials.  

UK PubMed Central (United Kingdom)

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.

Bayes M; Rabasseda X; Prous JR

2003-11-01

126

Collaborative trial on groundwater sampling  

Digital Repository Infrastructure Vision for European Research (DRIVER)

The trial presented here was conducted by BRGM in collaboration with LNE under the work program AQUAREF 2009 with the support of ONEMA. This is a collaborative trial on groundwater sampling and on field physico chemical measurement. It is not a proficiency test. He had three goals: * Observe and eva...

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

127

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

128

Patient Safety in Clinical Trials  

Science.gov (United States)

Information for patients, their families and friends, and the general public about how the rights and safety of people who take part in clinical trials are protected. Learn about informed consent, institutional review boards (IRB's), and how trials are closely monitored for safety.

129

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 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: Abiraterone acetate, acyline, adalimumab, adenosine triphosphate, AEE-788, AIDSVAX gp120 B/B, AK-602, alefacept, alemtuzumab, alendronic acid sodium salt, alicaforsen sodium, alprazolam, amdoxovir, AMG-162, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, aminophylline hydrate, anakinra, anecortave acetate, anti-CTLA-4 MAb, APC-8015, aripiprazole, aspirin, atazanavir sulfate, atomoxetine hydrochloride, atorvastatin calcium, atrasentan, AVE-5883, AZD-2171; Betamethasone dipropionate, bevacizumab, bimatoprost, biphasic human insulin (prb), bortezomib, BR-A-657, BRL-55730, budesonide, busulfan; Calcipotriol, calcipotriol/betamethasone dipropionate, calcium folinate, capecitabine, capravirine, carmustine, caspofungin acetate, cefdinir, certolizumab pegol, CG-53135, chlorambucil, ciclesonide, ciclosporin, cisplatin, clofarabine, clopidogrel hydrogensulfate, clozapine, co-trimoxazole, CP-122721, creatine, CY-2301, cyclophosphamide, cypher, cytarabine, cytolin; D0401, darbepoetin alfa, darifenacin hydrobromide, DASB, desipramine hydrochloride, desloratadine, desvenlafaxine succinate, dexamethasone, didanosine, diquafosol tetrasodium, docetaxel, doxorubicin hydrochloride, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecallantide, efalizumab, efavirenz, eletriptan, emtricitabine, enfuvirtide, enoxaparin sodium, estramustine phosphate sodium, etanercept, ethinylestradiol, etonogestrel, etonogestrel/ethinylestradiol, etoposide, exenatide; Famciclovir, fampridine, febuxostat, filgrastim, fludarabine phosphate, fluocinolone acetonide, fluorouracil, fluticasone propionate, fluvastatin sodium, fondaparinux sodium; Gaboxadol, gamma-hydroxybutyrate sodium, gefitinib, gelclair, gemcitabine, gemfibrozil, glibenclamide, glyminox; Haloperidol, heparin sodium, HPV 16/HPV 18 vaccine, human insulin, human insulin; Icatibant, imatinib mesylate, indium 111 (111In) ibritumomab tiuxetan, infliximab, INKP-100, iodine (I131) tositumomab, IoGen, ipratropium bromide, ixabepilone; L-870810, lamivudine, lapatinib, laquinimod, latanoprost, levonorgestrel, licochalcone a, liposomal doxorubicin, lopinavir, lopinavir/ritonavir, lorazepam, lovastatin; Maraviroc, maribavir, matuzumab, MDL-100907, melphalan, methotrexate, methylprednisolone, mitomycin, mitoxantrone hydrochloride, MK-0431, MN-001, MRKAd5 HIV-1 gag/pol/nef, MRKAd5gag, MVA.HIVA, MVA-BN Nef, MVA-Muc1-IL-2, mycophenolate mofetil; Nelfinavir mesilate, nesiritide, NSC-330507; Olanzapine, olmesartan medoxomil, omalizumab, oral insulin, osanetant; PA-457, paclitaxel, paroxetine, paroxetine hydrochloride, PCK-3145, PEG-filgrastim, peginterferon alfa-2a, peginterferon alfa-2b, perillyl alcohol, pexelizumab, pimecrolimus, pitavastatin calcium, porfiromycin, prasterone, prasugrel, pravastatin sodium, prednisone, pregabalin, prinomastat, PRO-2000, propofol, prostate cancer vaccine; Rasagiline mesilate, rhBMP-2/ACS, rhBMP-2/BCP, rhC1, ribavirin, rilpivirine, ritonavir, rituximab, Ro-26-9228, rosuvastatin calcium, rosuvastatin sodium, rubitecan; Selodenoson, simvastatin, sirolimus, sitaxsentan sodium, sorafenib, SS(dsFv)-PE38, St. John's Wort extract, stavudine; Tacrolimus, tadalafil, tafenoquine succinate, talaglumetad, tanomastat, taxus, tegaserod maleate, telithromycin, tempol, tenofovir, tenofovir disoproxil fumarate, testosterone enanthate, TH-9507, thalidomide, tigecycline, timolol maleate, tiotropium bromide, tipifarnib, torcetrapib, trabectedin, travoprost, travoprost/timolol, treprostinil sodium; Valdecoxib, vardenafil hydrochloride hydrate, varenicline, VEGF-2 gene therapy, venlafaxine hydrochloride, vildagliptin, vincristine sulfate, voriconazole, VRX-496, VX-385; Warfarin sodium; Ximelagatran; Yttrium 9

Bayés, M; Rabasseda, X; Prous, J R

2005-06-01

130

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

Directory of Open Access Journals (Sweden)

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

Xie Cheng-long; Gu Yong; Wang Wen-Wen; Lu Lin; Fu Deng-lei; Liu Ai-ju; Li Hui-qin; Li Ji-huang; Lin Yan; Tang Wen-jie; Zheng Guo-qing

2013-01-01

131

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

UK PubMed Central (United Kingdom)

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

Xie CL; Gu Y; Wang WW; Lu L; Fu DL; Liu AJ; Li HQ; Li JH; Lin Y; Tang WJ; Zheng GQ

2013-01-01

132

Clinical trials in neonatal sepsis.  

UK PubMed Central (United Kingdom)

Antibiotic licensing studies remain a problem in neonates. The classical adult clinical syndrome-based licensing studies do not apply to neonates, where sepsis is the most common infection. The main obstacle to conducting neonatal antibiotic trials is a lack of consensus on the definition of neonatal sepsis itself and the selection of appropriate endpoints. This article describes the difficulties of the clinical and laboratory definitions of neonatal sepsis and reviews the varying designs of previous neonatal sepsis trials. The optimal design of future trials of new antibiotics will need to be based on pharmacokinetic/pharmacodynamic parameters, combined with adequately powered clinical studies to determine safety and efficacy.

Oeser C; Lutsar I; Metsvaht T; Turner MA; Heath PT; Sharland M

2013-07-01

133

Modelling trial-by-trial changes in the mismatch negativity.  

Science.gov (United States)

The mismatch negativity (MMN) is a differential brain response to violations of learned regularities. It has been used to demonstrate that the brain learns the statistical structure of its environment and predicts future sensory inputs. However, the algorithmic nature of these computations and the underlying neurobiological implementation remain controversial. This article introduces a mathematical framework with which competing ideas about the computational quantities indexed by MMN responses can be formalized and tested against single-trial EEG data. This framework was applied to five major theories of the MMN, comparing their ability to explain trial-by-trial changes in MMN amplitude. Three of these theories (predictive coding, model adjustment, and novelty detection) were formalized by linking the MMN to different manifestations of the same computational mechanism: approximate Bayesian inference according to the free-energy principle. We thereby propose a unifying view on three distinct theories of the MMN. The relative plausibility of each theory was assessed against empirical single-trial MMN amplitudes acquired from eight healthy volunteers in a roving oddball experiment. Models based on the free-energy principle provided more plausible explanations of trial-by-trial changes in MMN amplitude than models representing the two more traditional theories (change detection and adaptation). Our results suggest that the MMN reflects approximate Bayesian learning of sensory regularities, and that the MMN-generating process adjusts a probabilistic model of the environment according to prediction errors. PMID:23436989

Lieder, Falk; Daunizeau, Jean; Garrido, Marta I; Friston, Karl J; Stephan, Klaas E

2013-02-21

134

Modelling trial-by-trial changes in the mismatch negativity.  

UK PubMed Central (United Kingdom)

The mismatch negativity (MMN) is a differential brain response to violations of learned regularities. It has been used to demonstrate that the brain learns the statistical structure of its environment and predicts future sensory inputs. However, the algorithmic nature of these computations and the underlying neurobiological implementation remain controversial. This article introduces a mathematical framework with which competing ideas about the computational quantities indexed by MMN responses can be formalized and tested against single-trial EEG data. This framework was applied to five major theories of the MMN, comparing their ability to explain trial-by-trial changes in MMN amplitude. Three of these theories (predictive coding, model adjustment, and novelty detection) were formalized by linking the MMN to different manifestations of the same computational mechanism: approximate Bayesian inference according to the free-energy principle. We thereby propose a unifying view on three distinct theories of the MMN. The relative plausibility of each theory was assessed against empirical single-trial MMN amplitudes acquired from eight healthy volunteers in a roving oddball experiment. Models based on the free-energy principle provided more plausible explanations of trial-by-trial changes in MMN amplitude than models representing the two more traditional theories (change detection and adaptation). Our results suggest that the MMN reflects approximate Bayesian learning of sensory regularities, and that the MMN-generating process adjusts a probabilistic model of the environment according to prediction errors.

Lieder F; Daunizeau J; Garrido MI; Friston KJ; Stephan KE

2013-01-01

135

Modelling Trial-by-Trial Changes in the Mismatch Negativity  

Science.gov (United States)

The mismatch negativity (MMN) is a differential brain response to violations of learned regularities. It has been used to demonstrate that the brain learns the statistical structure of its environment and predicts future sensory inputs. However, the algorithmic nature of these computations and the underlying neurobiological implementation remain controversial. This article introduces a mathematical framework with which competing ideas about the computational quantities indexed by MMN responses can be formalized and tested against single-trial EEG data. This framework was applied to five major theories of the MMN, comparing their ability to explain trial-by-trial changes in MMN amplitude. Three of these theories (predictive coding, model adjustment, and novelty detection) were formalized by linking the MMN to different manifestations of the same computational mechanism: approximate Bayesian inference according to the free-energy principle. We thereby propose a unifying view on three distinct theories of the MMN. The relative plausibility of each theory was assessed against empirical single-trial MMN amplitudes acquired from eight healthy volunteers in a roving oddball experiment. Models based on the free-energy principle provided more plausible explanations of trial-by-trial changes in MMN amplitude than models representing the two more traditional theories (change detection and adaptation). Our results suggest that the MMN reflects approximate Bayesian learning of sensory regularities, and that the MMN-generating process adjusts a probabilistic model of the environment according to prediction errors.

Lieder, Falk; Daunizeau, Jean; Garrido, Marta I.; Friston, Karl J.; Stephan, Klaas E.

2013-01-01

136

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

UK PubMed Central (United Kingdom)

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

De Vos M; Thorne JD; Yovel G; Debener S

2012-11-01

137

What Is a Clinical Trial?  

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

138

Basic Introduction to Clinical Trials  

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Full Text Available ... often helpful to talk to a physician, family members, or friends about deciding to participate a clinical ... the clinical trial and feel comfortable asking the members of the health care team questions about it, ...

139

Basic Introduction to Clinical Trials  

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Full Text Available ... trials have guidelines about who can participate. The factors that allow someone to participate in a clinical ... reliable results. These criteria are based on such factors as age, gender, the type and stage of ...

140

Basic Introduction to Clinical Trials  

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Full Text Available ... and effectiveness of their treatment. What is a placebo? A placebo is an inactive pill, liquid, or powder that ... clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some ...

 
 
 
 
141

What Is a Clinical Trial?  

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Full Text Available ... treatment as a patient in New York. But since the protocol is written for physicians, your doctor ... of a clinical trial cannot be guaranteed, and since the therapies and treatments are new, there's always ...

142

Critical Reading of Therapeutic Trials  

Directory of Open Access Journals (Sweden)

Full Text Available Critically reading therapeutic trials consists in determining whether the treatment studied offers a sufficient and relevant benefit to patients in daily medical practice. Thus, critical reading implies that we answer the following questions : are the results reliable? is the trial’s methodology dependable? are the statistical results reliable? what is its epistemological value? are the results reproducible? have they been confirmed by other trials and are they consistent with our basic knowledge on the subject? is the effect size large enough and how precise is its estimation? what is the risk-benefit ratio? are the results relevant to daily clinical practice, and how representative are the results and can they be extrapolated?

Cucherat M

2001-01-01

143

Basic Introduction to Clinical Trials  

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Full Text Available ... Informed consent is the process of learning the key facts about a clinical trial before deciding whether ... such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in ...

144

Basic Introduction to Clinical Trials  

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

145

Building Quality into Clinical Trials  

Science.gov (United States)

... Building Quality into Clinical Trials. To determine the safety and effectiveness of medical products, they must be studied in humans. ... More results from www.fda.gov/drugs/developmentapprovalprocess/smallbusinessassistance

146

Basic Introduction to Clinical Trials  

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Full Text Available ... widely available, and help others by contributing to medical research. Who can participate in a clinical trial? ... and exclusion criteria is an important principle of medical research that helps to produce reliable results. These ...

147

Basic Introduction to Clinical Trials  

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Full Text Available ... in clinical trials can play a more active role in their own health care, gain access to ... approach for eligible participants to: Play an active role in their health care decisions. Gain access to ...

148

Funded DCIS Projects: Clinical Trials  

Science.gov (United States)

Skip to Content Cancer Control and Population Sciences Home Applied Research Home Ductal Carcinoma in Situ Research Resources Funded DCIS Projects: Awarded NIH Grants Research with Non-NIH Funding Clinical Trials DCIS Resources: About Workshop Funding Funded

149

Basic Introduction to Clinical Trials  

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Full Text Available ... in a clinical trial that compares an experimental medicine or device with a standard treatment or placebo ... reported as being “likely” related to the experimental medicine, instead of “possibly related”. Or the participant might ...

150

What Is a Clinical Trial?  

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

151

Basic Introduction to Clinical Trials  

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Full Text Available ... for other expenses? What type of long-term follow up care is part of this study? How ... list of current trials/studies related to TSC. Follow the "TSC Road to the Special Olympbics" with ...

152

Basic Introduction to Clinical Trials  

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

153

Global warming on trial  

International Nuclear Information System (INIS)

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

1992-01-01

154

Global warming on trial  

Energy Technology Data Exchange (ETDEWEB)

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

Broeker, W.S.

1992-04-01

155

Malaria Diagnostics in Clinical Trials.  

UK PubMed Central (United Kingdom)

Malaria diagnostics are widely used in epidemiologic studies to investigate natural history of disease and in drug and vaccine clinical trials to exclude participants or evaluate efficacy. The Malaria Laboratory Network (MLN), managed by the Office of HIV/AIDS Network Coordination, is an international working group with mutual interests in malaria disease and diagnosis and in human immunodeficiency virus/acquired immunodeficiency syndrome clinical trials. The MLN considered and studied the wide array of available malaria diagnostic tests for their suitability for screening trial participants and/or obtaining study endpoints for malaria clinical trials, including studies of HIV/malaria co-infection and other malaria natural history studies. The MLN provides recommendations on microscopy, rapid diagnostic tests, serologic tests, and molecular assays to guide selection of the most appropriate test(s) for specific research objectives. In addition, this report provides recommendations regarding quality management to ensure reproducibility across sites in clinical trials. Performance evaluation, quality control, and external quality assessment are critical processes that must be implemented in all clinical trials using malaria tests.

Murphy SC; Shott JP; Parikh S; Etter P; Prescott WR; Stewart VA

2013-09-01

156

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

157

The International Stroke Trial database  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background We aimed to make individual patient data from the International Stroke Trial (IST), one of the largest randomised trials ever conducted in acute stroke, available for public use, to facilitate the planning of future trials and to permit additional secondary analyses. Methods For each randomised patient, we have extracted data on the variables assessed at randomisation, at the early outcome point (14-days after randomisation or prior discharge) and at 6-months and provide them as an analysable database. Results The IST dataset includes data on 19 435 patients with acute stroke, with 99% complete follow-up. Over 26.4% patients were aged over 80 years at study entry. Background stroke care was limited and none of the patients received thrombolytic therapy. Conclusions The IST dataset provides a source of primary data which could be used for planning further trials, for sample size calculations and for novel secondary analyses. Given the age distribution and nature of the background treatment given, the data may be of value in planning trials in older patients and in resource-poor settings.

Sandercock Peter AG; Niewada Maciej; Cz?onkowska Anna

2011-01-01

158

MRI lesions as a surrogate for relapses in multiple sclerosis: a meta-analysis of randomised trials.  

UK PubMed Central (United Kingdom)

BACKGROUND: A meta-analysis of randomised trials in relapsing-remitting multiple sclerosis published in 2009 showed a quantitative relation between the treatment effects detected on MRI lesions and clinical relapses. We aimed to validate that relation using data from a large and independent set of clinical trials in multiple sclerosis. METHODS: We searched Medline for clinical trials that assessed disease-modifying drugs for relapsing-remitting multiple sclerosis published from Sept 1, 2008, to Oct 31, 2012. We extracted data for the treatment effects on MRI lesions and on relapses from each trial, and the correlation of log transformed relative measures of these treatment effects was assessed with a weighted linear regression analysis. The R(2) value was estimated to quantify the strength of the correlation, and we used an interaction test to test for a difference in slope from the previously estimated equation. We also ran several sensitivity analyses. FINDINGS: We identified 31 eligible trials, which provided data for 18 901 patients with relapsing-remitting multiple sclerosis. The regression equation derived using data from these studies showed a relation between the concurrent treatment effects on MRI lesions and relapses (slope=0·52; R(2)=0·71), much the same as was previously estimated (pinteraction=0·45). Analysis of trials that tested the same drugs in phase 2 and phase 3 studies showed that the effects on MRI lesions over short follow-up periods (6-9 months) can also predict the effects on relapses over longer follow-up periods (12-24 months), with reported effects on relapses that were within the 95% prediction intervals in eight of nine trials. INTERPRETATION: Our findings indicate that the effect of a treatment on relapses can be accurately predicted by the effect of that therapy on MRI lesions, implying that the use of MRI markers as primary endpoints in future clinical trials of treatments for multiple sclerosis can be considered, in specific situations, such as in trials testing generics or biosimilars of drugs with a well known mechanism of action or in paediatric trials testing drugs already approved for adults. FUNDING: None.

Sormani MP; Bruzzi P

2013-07-01

159

Effects of supplementation with curcuminoids on dyslipidemia in obese patients: a randomized crossover trial.  

UK PubMed Central (United Kingdom)

Dyslipidemia is a leading risk factor for cardiovascular disease and is also a common feature of obesity. Curcumin is a bioactive phytochemical with well-known antioxidant, anti-inflammatory, and cardioprotective properties. The present study investigated the hypolipidemic activity of curcumin in obese individuals. Participants (n?=?30) were treated with curcuminoids (1?g/day), or placebo in a randomized, double-blind, placebo-controlled, crossover trial. Serum concentrations of total cholesterol, triglycerides, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol, together with anthropometric parameters and high-sensitivity C-reactive protein were measured before and after each treatment period. Anthropometric parameters including weight, BMI, waist circumference, hip circumference, arm circumference, and body fat remained statistically unchanged by the end of trial (p?>?0.05). As for the lipid profile parameters, serum triglycerides were significantly reduced following curcumin supplementation (p?=?0.009). However, curcuminoids were not found to affect serum levels of total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and high-sensitivity C-reactive protein (p?>?0.05). In summary, the findings of the present study indicated that curcuminoid supplementation (1?g/day for 30?days) leads to a significant reduction in serum triglycerides concentrations but do not have a significant influence on other lipid profile parameters as well as body mass index and body fat.

Mohammadi A; Sahebkar A; Iranshahi M; Amini M; Khojasteh R; Ghayour-Mobarhan M; Ferns GA

2013-03-01

160

Basic Introduction to Clinical Trials  

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Full Text Available ... before they are widely available. Obtain expert medical care at leading health care facilities during the trial. Help others by contributing ... and feel comfortable asking the members of the health care team questions about it, the care expected while ...

 
 
 
 
161

What Is a Clinical Trial?  

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

162

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.

163

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....

164

Basic Introduction to Clinical Trials  

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Full Text Available ... and the participant may withdraw from the trial at any time. If a participant is a non-English speaking person, federal guidelines require a version of the consent form be provided in a language the participant can understand. What is a protocol? ...

165

Baseline differences in the HF-ACTION trial by sex.  

UK PubMed Central (United Kingdom)

BACKGROUND: In patients with heart failure (HF), assessment of functional capacity plays an important prognostic role. Both 6-minute walk and cardiopulmonary exercise testing have been used to determine physical function and to determine prognosis and even listing for transplantation. However, as in HF trials, the number of women reported has been small, and the cutoffs for transplantation have been representative of male populations and extrapolated to women. It is also well known that peak VO(2) as a determinant of fitness is inherently lower in women than in men and potentially much lower in the presence of HF. Values for a female population from which to draw for this important determination are lacking. METHODS: The HF-ACTION trial randomized 2,331 patients (28% women) with New York Heart Association class II-IV HF due to systolic dysfunction to either a formal exercise program in addition to optimal medical therapy or to optimal medical therapy alone without any formal exercise training. To characterize differences between men and women in the interpretation of final cardiopulmonary exercise testing models, the interaction of individual covariates with sex was investigated in the models of (1) VE/VCO(2), (2) VO(2) at ventilatory threshold (VT), (3) distance on the 6-minute walk, and (4) peak VO(2). RESULTS: The women were younger than the men and more likely to have a nonischemic etiology and a higher ejection fraction. Dose of angiotensin converting enzyme inhibitor (ACEI) was lower in the women, on average. The lower ACEI dose may reflect the higher use of angiotensin II receptor blocker (ARB) in women. Both the peak VO(2) and the 6-minute walk distance were significantly lower in the women than in the men. Perhaps the most significant finding in this dataset of baseline characteristics is that the peak VO(2) for women was significantly lower than that for men with similar ventricular function and health status. CONCLUSION: Therefore, in a well-medicated, stable, class II-IV HF cohort of patients who are able to exercise, women have statistically significantly lower peak VO(2) and 6-minute walk distance than men with similar health status and ventricular function. These data should prompt careful thought when considering prognostic markers for women and listing for cardiac transplant.

Piña IL; Kokkinos P; Kao A; Bittner V; Saval M; Clare B; Goldberg L; Johnson M; Swank A; Ventura H; Moe G; Fitz-Gerald M; Ellis SJ; Vest M; Cooper L; Whellan D

2009-10-01

166

NIH Clinical Research Trials and You  

Science.gov (United States)

... at NIH NIH Director’s Blog NIH Home NIH Clinical Research Trials and You Home The Basics Finding a ... Common Terms If You Have a Question NIH Clinical Research Trials and You Highlights Working to Prevent Breast ...

167

National Emphysema Treatment Trial (NETT) Protocol.  

Science.gov (United States)

The National Emphysema Treatment Trial (NETT) is a multicenter, randomized clinical trial of usual medical therapy alone versus usual medical therapy plus lung reduction surgery (LVRS) for moderate to severe emphysema. Every patient will complete 6 to 10 ...

1999-01-01

168

Clinical Trials and Complementary and Alternative Medicine  

Science.gov (United States)

... trials in general and also to trials involving complementary and alternative medicine A group of diverse medical and health care ... place of conventional medicine. The National Center for Complementary and Alternative Medicine (NCCAM) is the Federal Government's lead agency for ...

169

Vaccines in trials for nicotine cessation therapy.  

UK PubMed Central (United Kingdom)

Three nicotine vaccines currently in clinical trials may offer alternatives to traditional pharmacologic smoking cessation therapy. Although the trial results are promising, these vaccines pose ethical questions and their role in clinical practice remains unclear.

Bennett L

2013-09-01

170

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.

McKinstry Brian; Hammersley Victoria; Daly Fergus; Sullivan Frank

2007-01-01

171

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

2007-01-01

172

Varied acceptance of clinical trial results.  

Science.gov (United States)

The subject of varied acceptance of clinical trial results is discussed in the context of review of trials with which I have been involved and my subjective evaluation of their impact on the practice of clinical medicine. My experience goes back to 1949 and a World Health Organization trial of hyperimmune gamma globulin against rabies. This was followed by a large trial of secondary prevention of poliomyelitis. I participated in the planning and initiation of the first chronic disease trial, the University Group Diabetes Program (UGDP). The latter lasted for 15 years and its ramifications continue to this day. My next trial was the Coronary Drug Project (CDP), a complex trial with more than 8,000 patients. The trials of aspirin and aspirin combined with persantine (the CDPA, AMIS, PARIS I, and PARIS II) followed. My last three trials were a trial of photocoagulation in diabetic retinopathy (DRS), a six-country trial of the antiarrhythmic drug mexiletine (IMPACT), and a study involving two diagnostic procedures for pulmonary embolism (PIOPED). When one considers, in retrospect, the plethora of trials one is struck by the uniform absence of a priori considerations of the impact on medical practice, or likely lack thereof, of possible outcomes. PMID:2605962

Klimt, C R

1989-12-01

173

Varied acceptance of clinical trial results.  

UK PubMed Central (United Kingdom)

The subject of varied acceptance of clinical trial results is discussed in the context of review of trials with which I have been involved and my subjective evaluation of their impact on the practice of clinical medicine. My experience goes back to 1949 and a World Health Organization trial of hyperimmune gamma globulin against rabies. This was followed by a large trial of secondary prevention of poliomyelitis. I participated in the planning and initiation of the first chronic disease trial, the University Group Diabetes Program (UGDP). The latter lasted for 15 years and its ramifications continue to this day. My next trial was the Coronary Drug Project (CDP), a complex trial with more than 8,000 patients. The trials of aspirin and aspirin combined with persantine (the CDPA, AMIS, PARIS I, and PARIS II) followed. My last three trials were a trial of photocoagulation in diabetic retinopathy (DRS), a six-country trial of the antiarrhythmic drug mexiletine (IMPACT), and a study involving two diagnostic procedures for pulmonary embolism (PIOPED). When one considers, in retrospect, the plethora of trials one is struck by the uniform absence of a priori considerations of the impact on medical practice, or likely lack thereof, of possible outcomes.

Klimt CR

1989-12-01

174

Quality of Variational Trial States  

CERN Multimedia

Besides perturbation theory (which clearly requires the knowledge of the exact unperturbed solution), variational techniques represent the main tool for any investigation of the eigenvalue problem of some semibounded operator H in quantum theory. For a reasonable choice of the employed trial subspace of the domain of H, the lowest eigenvalues of H usually can be located with acceptable precision whereas the trial-subspace vectors corresponding to these eigenvalues approximate, in general, the exact eigenstates of H with much less accuracy. Accordingly, various measures for the accuracy of the approximate eigenstates derived by variational techniques are scrutinized. In particular, the matrix elements of the commutator of the operator H and (suitably chosen) different operators with respect to degenerate approximate eigenstates of H obtained by variational methods are proposed as new criteria for the accuracy of variational eigenstates. These considerations are applied to precisely that Hamiltonian for which t...

Lucha, Wolfgang; Lucha, Wolfgang; Schoberl, Franz F.

1999-01-01

175

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

176

Medical coding in clinical trials.  

Science.gov (United States)

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 performed to categorize the medical terms reported appropriately so that they can be analyzed/reviewed. This article describes process which is used for medical coding in clinical data management and two most commonly used medical dictionaries MedDRA and WHO-DDE in brief. It is expected to help medical coders to understand the process of medical coding in clinical data management. Few common issues which the medical coder faces while performing medical coding, are also highlighted. PMID:21829779

Babre, Deven

2010-01-01

177

Medical coding in clinical trials.  

UK PubMed Central (United Kingdom)

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 performed to categorize the medical terms reported appropriately so that they can be analyzed/reviewed. This article describes process which is used for medical coding in clinical data management and two most commonly used medical dictionaries MedDRA and WHO-DDE in brief. It is expected to help medical coders to understand the process of medical coding in clinical data management. Few common issues which the medical coder faces while performing medical coding, are also highlighted.

Babre D

2010-01-01

178

Randomized controlled trials in pouchitis.  

UK PubMed Central (United Kingdom)

Pouchitis is the most common complication of Proctocolectomy with ileal pouch-anal anastomosis (IPAA) in patients with ulcerative colitis (UC). The diagnosis of pouchitis requires the presence of symptoms, together with characteristic endoscopic and histological abnormalities. The exact cause of pouchitis is not known. Whereas 'acute' pouchitis can be treated rapidly and successfully in the majority of patients, "refractory" and 'chronic pouchitis' remain therapeutic challenges to patients and physicians. Metronidazole and Ciprofloxacin budesonide enemas and oral probiotic therapy with VSL#3 all appear to be effective therapies for acute and/or chronic pouchitis. The medical therapy of pouchitis remains largely empiric, and additional multicenter, randomized, double-blind, placebo-con- trolled, dose-ranging trials are needed. In future trials, treatment indications such as active acute or chronic pouchitis and maintenance of remission for acute or chronic pouchitis should be clearly defined.

Gionchetti P; Calafiore A; Pratico C; Laureti S; Vitali G; Poggioli G; Campieri M; Rizzello F

2012-11-01

179

Bayesian Adaptive Methods for Clinical Trials  

CERN Multimedia

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

180

Neuroimaging outcomes for clinical trials.  

Science.gov (United States)

A wide range of drugs is currently under development for treating Alzheimer's Disease (AD). Clinical trials traditionally use rating scales, such as neuropsychological tests and disability scales, as outcome measures. However, their intrinsic measurement variability, the slow disease progression, and the low effectiveness of the drugs developed so far have led to trial designs with hundreds of subjects per treatment arm. Furthermore, a key issue is to establish what effect are these compounds having on the biological progression of the disease, beyond delaying symptomatic progression. The development of imaging markers, either structural, functional, or amyloid, with proven sensitivity to disease progression has recently paved the way for their use as outcome measures in clinical trials. The use of imaging measures has the double advantage of decreasing the number of subjects per treatment arm whilst also providing a direct measure of the degree of disease modification induced by the "active" molecules. The reviewed techniques, except for the most recent amyloid imaging, are those applied to prospective studies investigating changes of imaging markers over time. PMID:17653497

Frisoni, G B; Caroli, A

 
 
 
 
181

Market Trials of Irradiated Spices  

International Nuclear Information System (INIS)

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

2009-01-01

182

Challenges and opportunities in SLE clinical trials.  

UK PubMed Central (United Kingdom)

PURPOSE OF REVIEW: To provide an update on the field of clinical trials in systemic lupus erythematosus (SLE). This review will examine failed and successful clinical trials in SLE in order to draw lessons and determine the optimal ways forward. RECENT FINDINGS: Over the past decade, many clinical trials in SLE met with limited success, but in the past 2 years several SLE clinical trials have been successful. The two large phase III randomized controlled trials (RCTs) of belimumab achieved their primary endpoints and resulted in food and drug administration and European medicines agency approval of the drug. Characteristics of these trials were, among other things, a very large number of patients (>800 each), compound clinical endpoints, and a flexible design with regards to concomitant medication use. Likewise, large randomized controlled trials with mycophenolate mofetil, although nominally unsuccessful, clearly demonstrated the clinical benefit of this drug in lupus nephritis. Posthoc analyses of several failed trials involving abatacept and rituximab revealed design elements and/or outcomes that might have changed the outcomes of these studies. Many smaller trials have also been reported, in some instances with surprisingly positive results. SUMMARY: An improved understanding of specific design features in SLE clinical trials combined with robust outcomes will make it possible more effectively to design and conduct clinical trials in SLE.

van Vollenhoven RF

2013-09-01

183

Clinical trials: innovation, progress and controversy  

Directory of Open Access Journals (Sweden)

Full Text Available Greg S MartinDepartment of Pulmonary, Allergy and Critical Care, Emory University, Atlanta, Georgia, USAThe Open Access Journal of Clinical Trials began in 2009 with the goal of being an authoritative, open access source for international, peer-reviewed publications in the field of human research and clinical trials. Since then, the Open Access Journal of Clinical Trials has published approximately 30 high-quality articles on original research, innovative reviews, and critical commentaries. These articles have spanned many aspects of clinical trials wonderfully, including trial design and management; legal, ethical and regulatory issues of clinical trials; subject participation and retention in clinical trials; and data collection and data management.

Martin GS

2011-01-01

184

Discussion of treatment trials in intensive care.  

UK PubMed Central (United Kingdom)

PURPOSE: This study aimed to characterize whether and how the option of a treatment trial is discussed with surrogates in intensive care units. MATERIALS AND METHODS: We audio-recorded 72 family conferences for 72 patients at high risk for death or severe functional impairment in 5 intensive care units in San Francisco, California. We analyzed transcripts to develop a coding framework for whether and how trials were discussed. RESULTS: Trials were offered in 15% of conferences. We identified 2 types: (1) time-limited trials, defined as continuing all intensive, life-sustaining treatments, with a plan to reassess after a defined time period based on prespecified clinical milestones, and (2) symptom-limited trials, defined as using basic medical care aimed at survival (rather than purely comfort-focused treatment) once ventilatory support is withdrawn, with a plan to reassess based on patient symptoms. Clinicians frequently did not inform surrogates about key elements of the trial such as criteria by which the effectiveness of the trial would be evaluated and possible next steps based on trial results. CONCLUSIONS: In this cohort of critically ill patients, trials were infrequently and incompletely discussed. Additional work is needed to improve communication about treatment trials and evaluate their impact on patient and family outcomes.

Schenker Y; Tiver GA; Hong SY; White DB

2013-10-01

185

Maximizing scientific knowledge from randomized clinical trials  

DEFF Research Database (Denmark)

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

Gustafsson, Finn; Atar, Dan

2010-01-01

186

Microbicide clinical trial adherence: insights for introduction  

Directory of Open Access Journals (Sweden)

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

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

2013-01-01

187

Ethics review and clinical trials.  

UK PubMed Central (United Kingdom)

Author's replySir—Your editorial (Jan 24, p 225) advocating pragmatism in research ethics is of concern, particularly in view of The Lancet's willingness to lower its ethical standards for studies carried out in tyrannies.1 and 2 The proposed pragmatism of “compatible with the realities of health care in the country where the study is to be conducted” would sanction the work of Josef Mengele.3Responsibility for ethical standards cannot be completely devolved to local ethical committees because many factors other than ethical matters might influence their decisions. Questions need to be raised about why a particular population was chosen, who will benefit, and who has financed the research and why. The reason that trials of antiviral agents for the treatment of HIV are liable to be unethical in African countries is that the local population is unlikely to benefit from the results of the trial because of the cost of the drug. It is unethical to conduct research on a population when the results of that research will not be of use to that population. The non-availability of standard therapy in a particular healthcare system is not sufficient grounds to make placebo control still ethical. Those who want to pursue placebo-controlled trials of one agent may have had a hand in influencing the health authorities not to make standard treatment available, as might have happened in the UK with respect to ?-interferon for multiple sclerosis.International journals are a major bastion against unethical practice. The test is whether a journal such as The Lancet would refuse to publish a well-conducted and scientifically important study because it was unethical. A pragmatic approach suggests it would publish, giving the green light to unscrupulous investigators to travel the world looking for opportunities to conduct ethically dubious research.

Ellis SJ

1998-04-01

188

VTT Field Trial Finnish Experiences  

Energy Technology Data Exchange (ETDEWEB)

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

Martikka, Elina; Haemaelaeinen, Marko [Radiation and Nuclear Safety Authority (STUK), Helsinki (Finland)

2003-05-01

189

Amyloid imaging in clinical trials.  

UK PubMed Central (United Kingdom)

The possibility to map amyloid-beta, the Alzheimer's disease hallmark protein, in vivo opens the application for amyloid imaging in clinical trials with disease-modifying agents. Monitoring change in amyloid burden, particularly when potential amyloid-lowering drugs are at play, requires accurate analytical methods. Studies to date have used suboptimal methods that do not account for heterogeneous changes in flow associated with disease progression and potentially with anti-amyloid drugs. In this commentary, we discuss practical and methodological issues regarding longitudinal amyloid imaging and propose several quantitative, yet feasible, alternatives for reliable assessment of changes over time in amyloid burden.

Ossenkoppele R; Prins ND; van Berckel BN

2013-08-01

190

Trial burns for hazardous waste incinerators  

Energy Technology Data Exchange (ETDEWEB)

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

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

1987-01-01

191

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

UK PubMed Central (United Kingdom)

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 monitoring and congruency-based 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 whose recruitment varies with previous-trial congruency than with theories that link CSEs to previous-trial response conflict.

Weissman DH; Carp J

2013-01-01

192

Registro dos ensaios clínicos/ Clinical trials register  

Scientific Electronic Library Online (English)

Full Text Available Abstract in english The International Committee of Medical Journal Editors (ICMJE) proposed trials registration in a public trials registry, as a condition for publication. This policy started after July 1, 2005, and was supported by the World Association of Medical Editors (WAME). In May 19, 2006, the WHO urged 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 th (more) e 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.

Guimarães, Carlos Alberto

2007-06-01

193

Design of oncology clinical trials: a review.  

UK PubMed Central (United Kingdom)

Cancer is a disease that occurs due to the uncontrolled multiplication of cells that invade nearby tissues and can spread to other parts of the body. An increased incidence of cancer in the world has led to an increase in oncology research and in the number of oncology trials. Well designed oncology clinical trials are a key part of developing effective anti-cancer drugs. This review focuses on statistical considerations in the design and analysis of oncology clinical trials.

Ananthakrishnan R; Menon S

2013-10-01

194

Refuse derived fuel combustion trials  

Energy Technology Data Exchange (ETDEWEB)

In the UK in recent years the emphasis on energy from waste by combustion has been on the production of densified refuse derived fuel (dRDF). This arose because energy was seen as the prime resource that could be recovered from municipal solid waste (MSW) and it was anticipated that dRDF could take advantage of the large number of small to medium sized industrial and commercial coal fired boilers operating in the UK. However, the take up of RDF was much slower than expected. The prices of conventional fuels fell making RDF less attractive and a number of of combustion related problems, which are only now being solved, further limited the use of RDF. Warren Spring Laboratory (WSL) has been involved in dRDF combustion trials funded by the UK Departments of the Environnment and Energy (through the Energy Technology Support Unit (ETSU) on a range of coal fired appliances. This work has been supported by laboratory based programmes to establish the fundamental characteristics of RDF. The main findings from the trial programmes are summarised. (author)

Burnley, S.J. [Warren Spring Lab., Stevenage (United Kingdom)

1988-09-01

195

[Randomized controlled trials in psychiatry].  

UK PubMed Central (United Kingdom)

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

Jaeschke R; Siwek M; Brozek J; Brudkiewicz P

2012-01-01

196

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.

Watson Judith M; Torgerson David J

2006-01-01

197

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

198

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

Energy Technology Data Exchange (ETDEWEB)

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

Bartel, Regina

2009-09-15

199

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

Directory of Open Access Journals (Sweden)

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

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

2010-01-01

200

The chance to go in new Directions - the active use of solar energy for the air-conditioning of buildings is still not well known; Die Chance, neue Wege zu gehen  

Energy Technology Data Exchange (ETDEWEB)

This article discusses the use of solar energy not only for heating purposes, but also to provide cooling for buildings. Various ways of using electrical and thermal energy provided by solar systems are discussed, including classical compressor-based refrigeration technology as well as absorption and adsorption systems using silica gel and zeolite. Newer approaches such as Desiccant Evaporative Cooling and the use of fluid sorption agents are also briefly discussed. The article also describes several of the around twenty solar-supported cooling systems installed in Germany, including the first self-sufficient solar air-conditioning system at the University of Freiburg. The author stresses the necessity of keeping cooling loads in the buildings low and the central importance of the planning processes involved.

Mertz, G.

2002-07-01

 
 
 
 
201

Post SELECT: selenium on trial.  

UK PubMed Central (United Kingdom)

Selenium is an essential trace element for humans and other animals that is required in very small amounts for proper growth and functioning. Several selenium compounds have shown promise as cancer chemopreventive and chemotherapeutic agents. However, the negative outcome of the SELECT trial to some extent dampened the enthusiasm of selenium-related drug development. A look at the selenium compounds, their diverse mechanism of action, bioavailability and efficacy based on chemical structure, however, suggests that failure of SELECT that used selenomethionine supplement to prevent prostate cancer was not a failure of selenium compounds as a whole. This is certainly true in regard to therapeutic applications of selenium compounds. This article puts these arguments in perspective, and based on the literature reports, especially several newly developed selenium compounds, emphasizes the importance of selenium in the development of chemopreventive and particularly chemotherapeutic drugs for cancer in near future.

Sharma AK; Amin S

2013-02-01

202

Safety Monitoring in Clinical Trials  

Directory of Open Access Journals (Sweden)

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

Bin Yao; Li Zhu; Qi Jiang; H. Amy Xia

2013-01-01

203

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

UK PubMed Central (United Kingdom)

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

Berghmans TM; Hulsewé KW; Buurman WA; Luyer MD

2012-01-01

204

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.

1997-01-01

205

Safety methodology in pediatric psychopharmacology trials.  

UK PubMed Central (United Kingdom)

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

Yuill K; Carandang C

2013-04-01

206

Internet-delivered attention modification training as a treatment for social phobia: a randomized controlled trial.  

UK PubMed Central (United Kingdom)

Attentional biases toward social threat are a well-known phenomenon in social phobia. Recently, computer-delivered trainings have been developed to modify these patterns of attention and thereby reduce anxiety symptoms. Distribution of such attention trainings (ATs) via internet might be a promising approach in overcoming obstacles in health care utilization. However, there is no evidence supporting the effectiveness of internet-based ATs in clinical populations. The current trial examined effects of an internet-based AT on self-report measures, behavioral data and diagnostic status in individuals with social phobia (N = 56). Participants were randomly assigned to either AT using a modified dot probe paradigm or a control condition without attention modification. After training and at a 4-month follow-up, both groups showed small, albeit significant reductions in social anxiety and depression, but there was no evidence for superiority of the AT condition. The present findings question the effectiveness of internet-based ATs in social phobia. Future studies need to investigate effective variants of internet-based ATs before they can be widely applied.

Neubauer K; von Auer M; Murray E; Petermann F; Helbig-Lang S; Gerlach AL

2013-02-01

207

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

Ünlü Ça?da?; de Korte Niels; Daniels Lidewine; Consten Esther CJ; Cuesta Miguel A; Gerhards Michael F; van Geloven Anna AW; van der Zaag Edwin S; van der Hoeven Joost AB; Klicks Rutger; Cense Huib A; Roumen Rudi MH; Eijsbouts Quirijn AJ; Lange Johan F; Fockens Paul; de Borgie Corianne AJM; Bemelman Wilem A; Reitsma Johannes B; Stockmann Hein BAC; Vrouenraets Bart C; Boermeester Marja A

2010-01-01

208

Single-Trial Inference on Visual Attention  

DEFF Research Database (Denmark)

In this paper we take a step towards single-trial behavioral modeling within a Theory of Visual Attention (TVA). In selective attention tasks, such as the Partial Report paradigm, the subject is asked to ignore distractors and only report stimuli that belong to the target class. Nothing about a distractor is observed directly in the subject’s overt behavior, hence behavioral modeling of such trials involves out-marginalizing the variables that represent the distractors’ influence on behavior. In this paper we derive equations for inferring a latent representation of the distractors on a Partial Report trial. This result retrodicts a latent attentional state of the subject using the observed response from that particular trial and thus differs from other predictions made with TVA which are based on expected values of observed variables. We show an example of the result in single-trial analysis of an occipital EEG component.

Dyrholm, Mads; Kyllingsbæk, SØren

2011-01-01

209

Bayesian adaptive trials offer advantages in comparative effectiveness trials: an example in status epilepticus.  

UK PubMed Central (United Kingdom)

OBJECTIVE: We present a novel Bayesian adaptive comparative effectiveness trial comparing three treatments for status epilepticus that uses adaptive randomization with potential early stopping. STUDY DESIGN AND SETTING: The trial will enroll 720 unique patients in emergency departments and uses a Bayesian adaptive design. RESULTS: The trial design is compared to a trial without adaptive randomization and produces an efficient trial in which a higher proportion of patients are likely to be randomized to the most effective treatment arm while generally using fewer total patients and offers higher power than an analogous trial with fixed randomization when identifying a superior treatment. CONCLUSION: When one treatment is superior to the other two, the trial design provides better patient care, higher power, and a lower expected sample size.

Connor JT; Elm JJ; Broglio KR

2013-08-01

210

Reporting Complaints Related to FDA-Regulated Clinical Trials  

Science.gov (United States)

... Science and Research Special Topics Clinical Trials and Human Subject Protection - Section Contents Menu Science and Research Special Topics Clinical Trials and Human Subject Protection Complaints relating to Clinical trials - Reporting Complaints Related ...

211

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

Directory of Open Access Journals (Sweden)

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; Wu Zhen-Jie; Wang Peng-Fei; Aung Lynn Htet Htet; Yin Rui-Xing

2012-01-01

212

The Mycotic Ulcer Treatment Trial  

Science.gov (United States)

Objective To compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis. Methods This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. Main Outcome Measures The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. Results A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycin-treated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=?0.18 logMAR; 95% CI, ?0.30 to ?0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=?0.41 logMAR; 95% CI, ?0.61 to ?0.20; P<.001; odds ratio for perforation=0.06; 95% CI, 0.01 to 0.28; P<.001), while non-Fusarium cases fared similarly (regression coefficient=?0.02 logMAR; 95% CI, ?0.17 to 0.13; P=.81; odds ratio for perforation=1.08; 95% CI, 0.48 to 2.43; P=.86). Conclusions Natamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. Application to Clinical Practice Voriconazole should not be used as monotherapy in filamentous keratitis. Trial Registration clinicaltrials.gov Identifier: NCT00996736

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

2013-01-01

213

Cancer screening trials: nuts and bolts.  

UK PubMed Central (United Kingdom)

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

Prorok PC; Marcus PM

2010-06-01

214

The Clinical Trials Transformation Initiative (CTTI).  

UK PubMed Central (United Kingdom)

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 initiative 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.

Grignolo A

2011-01-01

215

Limits to clinical trials in surgical areas  

Scientific Electronic Library Online (English)

Full Text Available Abstract in english Randomized clinical trials are considered to be the gold standard of evidence-based medicine nowadays. However, it is important that we point out some limitations of randomized clinical trials relating to surgical interventions. There are limitations that affect the external and internal validity of many surgical study designs. Some limitations can be bypassed, but can make it more difficult for the study to be carried out. Other limitations cannot be bypassed. When it is (more) intended to extrapolate the result of a randomized clinical trial, the premise is that the performed or to be performed intervention will be similar wherever applied and/or for every doctor using it. However, no matter how standardized the technique may be, the results are not similar for all surgeons, which implies a significant limitation to surgical randomized clinical trials concerning external validity. When considering the various limitations presented for performing surgical trials capable of generating scientific evidence within the patterns currently proposed in the evidence level classifications of medical publications, it is necessary to rethink whether those scientific evidence levels are similarly applicable to surgical works and to nonsurgical trials. We currently live in a time of supposed ''inferiority'' of surgical scientific works under the optics of the current quality criteria for a ''suitable'' clinical trial

Demange, Marco Kawamura; Fregni, Felipe

2011-01-01

216

Sponsorship and design characteristics of trials registered in ClinicalTrials.gov.  

UK PubMed Central (United Kingdom)

OBJECTIVE: We examine the extent to which ClinicalTrials.gov is meeting its goal of providing oversight and transparency of clinical trials with human subjects. We analyzed the ClinicalTrials.gov database contents as of June 2011, comparing interventions, medical conditions, and trial characteristics by sponsor type. We also conducted a detailed analysis of incomplete data. RESULTS: Among trials with only government sponsorship (N=9252), 36% were observational and 64% interventional; in contrast, almost all (90%) industry-only sponsored trials were interventional. Industry-only sponsored interventional trials (N=30,036) were most likely to report a drug intervention (81%), followed by biologics (9%) and devices (8%). Government-only interventional trials (N=5886) were significantly more likely to test behavioral interventions (28%) and procedures (13%) than industry-only trials (p<0.001). Medical conditions most frequently studied in industry-only trials were cancer (19%), cardiovascular conditions (12%) and endocrine/metabolic disorders (11%). Government-only funded trials were more likely to study mental health (19% vs. 7% for industry, p<.001), and viral infections, including HIV (15% vs 7% for industry, p<.001). Government-funded studies are significantly more likely to be missing data about study design and intervention arms in the registry. For all studies, we report ambiguous and contradictory data entries. CONCLUSIONS: Industry-sponsored studies differ systematically from government-sponsored studies in study type, choice of interventions, conditions studied, and completeness of submitted information. Imprecise study design information, incomplete coding of conditions, out-of-date or unspecified enrollment numbers, and other missing data continue to hinder robust analyses of trials registered in ClinicalTrials.gov.

Roumiantseva D; Carini S; Sim I; Wagner TH

2013-03-01

217

Are explanatory trials ethical? Shifting the burden of justification in clinical trial design.  

UK PubMed Central (United Kingdom)

Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under "ideal" conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under "usual" conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs.

Borgerson K

2013-08-01

218

Are explanatory trials ethical? Shifting the burden of justification in clinical trial design.  

Science.gov (United States)

Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under "ideal" conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under "usual" conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs. PMID:23812957

Borgerson, Kirstin

2013-08-01

219

Genomic sequencing in clinical trials  

Directory of Open Access Journals (Sweden)

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

Mestan Karen K; Ilkhanoff Leonard; Mouli Samdeep; Lin Simon

2011-01-01

220

IAEA monitoring field trials workshop  

Energy Technology Data Exchange (ETDEWEB)

Recent safeguards inspections in Iraq and elsewhere by the International Atomic Energy Agency (IAEA) have led to the supposition that environmental monitoring can aid in verifying declared and in detecting undeclared nuclear activities or operations. This assumption was most recently examined by the IAEA`s Standing Advisory Group on Safeguards Implementation (SAGSI), in their reports to the IAEA Board of Governors. In their reports, SAGSI suggested that further assessment and development of environmental monitoring would be needed to fully evaluate its potential application to enhanced IAEA safeguards. Such an inquiry became part of the IAEA ``Programme 93+2`` assessment of measures to enhance IAEA safeguards. In March, 1994, the International Safeguards Group at Oak Ridge hosted an environmental monitoring field trial workshop for IAEA inspectors to train them in the techniques needed for effective environmental sampling. The workshop included both classroom lectures and actual field sampling exercises. The workshop was designed to emphasize the analytical infrastructure needed for an environmental program, practical sampling methods, and suggested procedures for properly planning a sampling campaign. Detailed techniques for swipe, vegetation, soil, biota, and water associated sampling were covered. The overall approach to the workshop, and observed results, are described.

Ross, H.H.; Cooley, J.N.; Belew, W.L. [Lockheed Martin Energy Systems, Oak Ridge, TN (United States)

1995-12-31

 
 
 
 
221

From ClinicalTrials.gov trial registry to an analysis-ready database of clinical trial results.  

UK PubMed Central (United Kingdom)

BACKGROUND: The ClinicalTrials.gov web site provides a convenient interface to look up study results, but it does not allow downloading data in a format that can be readily used for quantitative analyses. PURPOSE: To develop a system that automatically downloads study results from ClinicalTrials.gov and provides an interface to retrieve study results in a spreadsheet format ready for analysis. METHODS: Sherlock(®) identifies studies by intervention, population, or outcome of interest and in seconds creates an analytic database of study results ready for analyses. The outcome classification algorithms used in Sherlock were validated against a classification by an expert. CONCLUSIONS: Having a database ready for analysis that can be updated automatically, dramatically extends the utility of the ClinicalTrials.gov trial registry. It increases the speed of comparative research, reduces the need for manual extraction of data, and permits answering a vast array of questions.

Cepeda MS; Lobanov V; Berlin JA

2013-04-01

222

Potential bias in ophthalmic pharmaceutical clinical trials  

Directory of Open Access Journals (Sweden)

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

Paul Varner

2008-01-01

223

The ARUBA trial: current status, future hopes.  

UK PubMed Central (United Kingdom)

BACKGROUND AND PURPOSE: Report on the status of an on-going National Institutes of Neurological Disorders and Stroke (NINDS)-supported clinical trial of management of unbled brain arteriovenous malformations. SUMMARY OF REVIEW: Begun in April 2007 with 3 centers, the trial has grown to 65 centers, and has randomized 124 patients through mid-June 2010 en route to the planned 400. The current literature continues to support the rationale for the trial. CONCLUSIONS: ARUBA is steadily approaching its monthly randomization goals and has already reached the number needed to test the maximum published interventional complication rates against the minimum hemorrhage rates for natural history.

Mohr JP; Moskowitz AJ; Stapf C; Hartmann A; Lord K; Marshall SM; Mast H; Moquete E; Moy CS; Parides M; Pile-Spellman J; Al-Shahi Salman R; Weinberg A; Young WL; Estevez A; Kureshi I; Brisman JL

2010-08-01

224

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

2010-01-01

225

From the laboratory to clinical trials and back again: lessons learned from HIV prevention trials.  

UK PubMed Central (United Kingdom)

PROBLEM: Inadequate, irrelevant, or inappropriate timing of biological specimen collection during clinical trials is a cause for delay in understanding and explaining correlates of protection and/or effectiveness, particularly at the portal of entry in the context of sexual HIV transmission and its prevention. METHODS: We present examples of HIV prevention trials to illustrate the impact of preplanned versus unplanned laboratory science program on the interpretation of trial results and advancement of the field. RESULTS: Of the five completed pre-exposure prophylaxis trials, only two announced main outcome results simultaneously with data on correlates of drug-related effectiveness. In four of the vaccine trials completed, the only one that showed a protective effect presented data on protection correlates significantly later. CONCLUSION: Clinical trials must preplan collaborative immunophysiological research and prioritize biological specimen collection and storage for enhancement of research on correlates of protection. Similarly appropriate specimens should be prioritized for pathogenesis research.

Sibeko S; Makvandi-Nejad S

2013-02-01

226

The Perth fuel cell bus trial  

Energy Technology Data Exchange (ETDEWEB)

This paper presents in a short way the Perth fuel bus trial aspects as follows: project background; operating conditions; operational results; life cycle analysis; public perceptions; economic analysis; questions.

Cockroft, Colin [Murdoch University, Perth, Western Australia (Australia)

2006-07-01

227

Constructing common cohorts from trials with overlapping eligibility criteria: implications for comparing effect sizes between trials.  

UK PubMed Central (United Kingdom)

BACKGROUND: Comparing findings from separate trials is necessary to choose among treatment options, however differences among study cohorts may impede these comparisons. PURPOSE: As a case study, to examine the overlap of study cohorts in two large randomized controlled clinical trials that assess interventions to reduce risk of major cardiovascular disease events in adults with type 2 diabetes in order to explore the feasibility of cross-trial comparisons METHODS: The Action for Health in Diabetes (Look AHEAD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trials enrolled 5145 and 10,251 adults with type 2 diabetes, respectively. Look AHEAD assesses the efficacy of an intensive lifestyle intervention designed to produce weight loss; ACCORD tests pharmacological therapies for control of glycemia, hyperlipidemia, and hypertension. Incidence of major cardiovascular disease events is the primary outcome for both trials. A sample was constructed to include participants from each trial who appeared to meet eligibility criteria and be appropriate candidates for the other trial's interventions. Demographic characteristics, health status, and outcomes of members and nonmembers of this constructed sample were compared. RESULTS: Nearly 80% of Look AHEAD participants were projected to be ineligible for ACCORD; ineligibility was primarily due to better glycemic control or no early history of cardiovascular disease. Approximately 30% of ACCORD participants were projected to be ineligible for Look AHEAD, often for reasons linked to poorer health. The characteristics of participants projected to be jointly eligible for both trials continued to reflect differences between trials according to factors likely linked to retention, adherence, and study outcomes. LIMITATIONS: Accurate ascertainment of cross-trial eligibility was hampered by differences between protocols. CONCLUSIONS: Despite several similarities, the Look AHEAD and ACCORD cohorts represent distinct populations. Even within the subsets of participants who appear to be eligible and appropriate candidates for trials of both modes of intervention, differences remained. Direct comparisons of results from separate trials of lifestyle and pharmacologic interventions are compromised by marked differences in enrolled cohorts.

Mount DL; Feeney P; Fabricatore AN; Coday M; Bahnson J; Byington R; Phelan S; Wilmoth S; Knowler WC; Hramiak I; Osei K; Sweeney ME; Espeland MA

2009-10-01

228

Randomized clinical stroke trials in 2006.  

Science.gov (United States)

This article reviews randomized control trials (RCT's) published in 2006 of various medications evaluated for stroke patients. These trials were primarily efficacy studies. These included aggrenox (an antiplatelet agent), magnesium (to treat arterial spasm after an aneurysmal subarachnoid hemorrhage), NXY (a free radical trapping agent) and albumin which were both tested as a neuroprotectant, amphetamine (to aid motor recovery), fluoxetine (an anti-depressant and anxiolytic) and low molecular weight heparin (for prevention of deep vein thrombosis post-stroke). PMID:18220941

Rabadi, Meheroz H; Blass, John P

2008-01-01

229

International guidelines for clinical trials with pediculicides.  

UK PubMed Central (United Kingdom)

Pediculosis capitis, infestation with head lice, is common in all human societies. Chemical pediculicides are often used to control head louse infestations, particularly in wealthy communities. A significant number of different protocols have been used to test the efficacy and safety of pediculicides in clinical trials; this constrains scientific comparison of the evidence for efficacy of the different pediculicides. Here we recommend protocols for clinical trials of the efficacy and safety of single-, two-, and three-treatment interventions.

Barker SC; Burgess I; Meinking TL; Mumcuoglu KY

2012-07-01

230

Therapeutic trials for systemic sclerosis: An update  

Directory of Open Access Journals (Sweden)

Full Text Available The pathogenesis of systemic sclerosis (SSc) is complex, and the final story is yet to be elucidated. The clinical heterogeneity of the disease, its various autoimmune and antibody profiles, its long course and tendency for spontaneous cure makes the design of clinical trials difficult. The overwhelming need in this disease is to diagnose it early and identify those patients who will benefit most from early, aggressive treatment. We attempt to review data from recent clinical trials and the lessons derived.

Sardana Kabir; Garg V

2008-01-01

231

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

Directory of Open Access Journals (Sweden)

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

Graffy Jonathan; Bower Peter; Ward Elaine; Wallace Paul; Delaney Brendan; Kinmonth Ann-Louise; Collier David; Miller Julia

2010-01-01

232

More outcomes than trials: a call for consistent data collection across stroke rehabilitation trials.  

Science.gov (United States)

Stroke survivors experience complex combinations of impairments, activity limitations, and participation restrictions. The essential components of stroke rehabilitation remain elusive. Determining efficacy in randomized controlled trials (RCTs) is challenging; there is no commonly agreed primary outcome measure for rehabilitation trials. Clinical guidelines depend on proof of efficacy in RCTs and meta-analyses. However, diverse trial aims, differing methods, inconsistent data collection, and use of multiple assessment tools hinder comparability across trials. Consistent data collection in acute stroke trials has facilitated meta-analyses to inform trial design and clinical practice. With few exceptions, inconsistent data collection has hindered similar progress in stroke rehabilitation research. There is an urgent need for the routine collection of a core dataset of common variables in rehabilitation trials. The European Stroke Organisation Outcomes Working Group, the National Institutes of Neurological Disorders and Stroke Common Data Elements project, and the Collaborative Stroke Audit and Research project have called for consistency in data collection in stroke trials. Standardizing data collection can decrease study start up times, facilitate data sharing, and inform clinical guidelines. Although achieving consensus on which outcome measures to use in stroke rehabilitation trials is a considerable task, perhaps a feasible starting point is to achieve consistency in the collection of data on demography, stroke severity, and stroke onset to inclusion times. Longer term goals could include the development of a consensus process to establish the core dataset. This should be endorsed by researchers, funders, and journal editors in order to facilitate sustainable change. PMID:23280265

Ali, M; English, C; Bernhardt, J; Sunnerhagen, K S; Brady, M

2013-01-01

233

Qualitative research within trials: developing a standard operating procedure for a clinical trials unit.  

UK PubMed Central (United Kingdom)

BACKGROUND: Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. METHODS: Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). RESULTS: The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. CONCLUSIONS: We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials.

Rapport F; Storey M; Porter A; Snooks H; Jones K; Peconi J; Sánchez A; Siebert S; Thorne K; Clement C; Russell I

2013-01-01

234

Developing antitussives: the ideal clinical trial.  

UK PubMed Central (United Kingdom)

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

Birring SS

2009-04-01

235

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

Directory of Open Access Journals (Sweden)

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

Craig Fiona F; Thomas Kim S; Mitchell Eleanor J; Williams Hywel C; Norrie John; Mason James M; Ormerod Anthony D

2012-01-01

236

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.  

UK PubMed Central (United Kingdom)

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 FF; Thomas KS; Mitchell EJ; Williams HC; Norrie J; Mason JM; Ormerod AD

2012-01-01

237

Internet trials: participant experiences and perspectives  

Directory of Open Access Journals (Sweden)

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

Mathieu Erin; Barratt Alexandra; Carter Stacy M; Jamtvedt Gro

2012-01-01

238

Information on blinding in registered records of clinical trials  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Information on blinding is part of the data that should be provided upon registration of a trial at a clinical trials registry. Reporting of blinding is often absent or of low quality in published articles of clinical trials. This study researched the presence and quality of information on blinding in registered records of clinical trials and highlights the important role of data-recording formats at clinical trial registries in ensuring high-quality registration.

Viergever Roderik F; Ghersi Davina

2012-01-01

239

Clinical trials in ALS: what did we learn from recent trials in humans?  

UK PubMed Central (United Kingdom)

Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disease. No treatment is currently able to stop the disease process. In the absence of new active compounds there is an urgent need to develop new strategies based on the neuroprotective activity of available drugs. ALS is a heterogeneous disease. To build up these therapeutic trials, we need to have a better understanding of the prognostic factors in this disease. During the Phase IV Rilutek Trial in France, we developed in a large population of patients a prognostic score based on clinical parameters available at the bedside. The most significant variables are vital capacity, spasticity, fasciculations, swallowing, cough and creatininemia. This score proved to be very useful in daily use in the clinic and for planning disease management in ALS as in the design of therapeutic trials. In ALS clinical trials, efficacy can be evaluated using survival or functional parameters. In phase II trials, function remains the most commonly used. In phase III trials, the gold standard endpoint remains the survival rate at month 18. We analyzed the most recent ALS trials published in the literature. This review suggests that in these trials there is a discrepancy between drug effects on survival versus function. These results suggest that a reappraisal of strategies to identify therapeutic targets for ALS is required.

Meininger V

2005-01-01

240

Clinical trials in ALS: what did we learn from recent trials in humans?  

Science.gov (United States)

Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disease. No treatment is currently able to stop the disease process. In the absence of new active compounds there is an urgent need to develop new strategies based on the neuroprotective activity of available drugs. ALS is a heterogeneous disease. To build up these therapeutic trials, we need to have a better understanding of the prognostic factors in this disease. During the Phase IV Rilutek Trial in France, we developed in a large population of patients a prognostic score based on clinical parameters available at the bedside. The most significant variables are vital capacity, spasticity, fasciculations, swallowing, cough and creatininemia. This score proved to be very useful in daily use in the clinic and for planning disease management in ALS as in the design of therapeutic trials. In ALS clinical trials, efficacy can be evaluated using survival or functional parameters. In phase II trials, function remains the most commonly used. In phase III trials, the gold standard endpoint remains the survival rate at month 18. We analyzed the most recent ALS trials published in the literature. This review suggests that in these trials there is a discrepancy between drug effects on survival versus function. These results suggest that a reappraisal of strategies to identify therapeutic targets for ALS is required. PMID:16909027

Meininger, Vincent

2005-01-01

 
 
 
 
241

Roadmap for the European Network of Gynaecological Trial groups (ENGOT) Trials.  

UK PubMed Central (United Kingdom)

The European Network for Gynaecological Oncological Trial groups (ENGOT) is a research network of the European Society of Gynaecological Oncology and was founded in Berlin in October 2007. Earlier, we reported on the ENGOT minimal requirements for trials between academic groups and pharmaceutical companies. In this paper, we summarize the roadmap for performing trials in the ENGOT framework. In this roadmap, we define how an ENGOT trial should be set up and discuss the following items: What are the conditions to classify a study as an ENGOT trial? What is an ENGOT protocol? How are an ENGOT protocol, informed consent (ICF), and case report form (CRF) produced? How is the center selection and feasibility performed in ENGOT trials? How are regulatory and operational tasks handled? How should a confidentiality agreement between the industry and the whole ENGOT network be negotiated? How are contracts made between the industry and ENGOT and between ENGOT groups? How are funding, insurance, and communication flow arranged in ENGOT trials? What are the requirements for conducting substudies and what are the tasks for the leading group in an ENGOT trial? A template of a confidentiality agreement, a checklist of ENGOT criteria for new study proposals, and guidelines for authorship are also provided.

Vergote I; Elser G; Votan B; Farrelly L; De Roover J; Bryce J; du Bois A

2013-09-01

242

Roadmap for the European Network of Gynaecological Trial groups (ENGOT) Trials.  

Science.gov (United States)

The European Network for Gynaecological Oncological Trial groups (ENGOT) is a research network of the European Society of Gynaecological Oncology and was founded in Berlin in October 2007. Earlier, we reported on the ENGOT minimal requirements for trials between academic groups and pharmaceutical companies. In this paper, we summarize the roadmap for performing trials in the ENGOT framework. In this roadmap, we define how an ENGOT trial should be set up and discuss the following items: What are the conditions to classify a study as an ENGOT trial? What is an ENGOT protocol? How are an ENGOT protocol, informed consent (ICF), and case report form (CRF) produced? How is the center selection and feasibility performed in ENGOT trials? How are regulatory and operational tasks handled? How should a confidentiality agreement between the industry and the whole ENGOT network be negotiated? How are contracts made between the industry and ENGOT and between ENGOT groups? How are funding, insurance, and communication flow arranged in ENGOT trials? What are the requirements for conducting substudies and what are the tasks for the leading group in an ENGOT trial? A template of a confidentiality agreement, a checklist of ENGOT criteria for new study proposals, and guidelines for authorship are also provided. PMID:23970159

Vergote, Ignace; Elser, Gabriele; Votan, Benedicte; Farrelly, Laura; De Roover, Joke; Bryce, Jane; du Bois, Andreas

2013-09-01

243

Biomarkers in T cell therapy clinical trials  

Directory of Open Access Journals (Sweden)

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

2011-01-01

244

Ethical issues in naturalistic versus controlled trials.  

UK PubMed Central (United Kingdom)

Ethical core issues in research with human subjects are related to informed consent and risk-benefit assessment. This is valid for all types of studies. However, there has been much greater focus of ethical considerations on controlled clinical trials than on naturalistic trials, probably because the former are interventional in nature and may have unknown and perhaps severe somatic risks, whereas naturalistic studies seem not to intervene but only to observe, and therefore are assumed to have fewer or almost no risks. However, there are also ethical implications in naturalistic trials, although their weight is differently accentuated, more with potential, more with potential psychological burdens of the observational procedures and more with potential physical risks in interventional trials. This will be elaborated with examples of placebo-controlled trials and of incidental findings in screenings, of marketing influences on observational studies, and of psychological burdens by survey interviews. The ethical implications will be analyzed within a more general framework. Finally, recommendations will be offered.

Helmchen H

2011-01-01

245

Prostate cancer vaccines in clinical trials.  

Science.gov (United States)

This review presents important information about the current state of the art for vaccine immunotherapy of prostate cancer. It includes important preclinical research for each of the important prostate cancer vaccines to have reached clinical trials. To date, the only prostate cancer vaccine that has completed Phase III trials and has been approved and licensed by the US FDA is Sipuleucel-T, which immunizes patients against the prostate-associated antigen prostatic acid phosphatase. The benefits and concerns associated with the vaccine are presented. A current Phase III trial is currently underway using the vaccinia-based prostate-specific antigen vaccine Prostvac-TRICOM. Other immunotherapeutic vaccines in trials include the Ad/prostate-specific antigen vaccine Ad5-prostate-specific antigen and the DNA/prostatic acid phosphatase vaccine. A cellular vaccine, GVAX, has been in clinical trials but has not seen continuous study. This review also delves into the multiple immune regulatory elements that must be overcome in order to obtain strong antitumor-associated antigen immune responses capable of effectively destroying prostate tumor cells. PMID:22913261

Lubaroff, David M

2012-07-01

246

Prostate cancer vaccines in clinical trials.  

UK PubMed Central (United Kingdom)

This review presents important information about the current state of the art for vaccine immunotherapy of prostate cancer. It includes important preclinical research for each of the important prostate cancer vaccines to have reached clinical trials. To date, the only prostate cancer vaccine that has completed Phase III trials and has been approved and licensed by the US FDA is Sipuleucel-T, which immunizes patients against the prostate-associated antigen prostatic acid phosphatase. The benefits and concerns associated with the vaccine are presented. A current Phase III trial is currently underway using the vaccinia-based prostate-specific antigen vaccine Prostvac-TRICOM. Other immunotherapeutic vaccines in trials include the Ad/prostate-specific antigen vaccine Ad5-prostate-specific antigen and the DNA/prostatic acid phosphatase vaccine. A cellular vaccine, GVAX, has been in clinical trials but has not seen continuous study. This review also delves into the multiple immune regulatory elements that must be overcome in order to obtain strong antitumor-associated antigen immune responses capable of effectively destroying prostate tumor cells.

Lubaroff DM

2012-07-01

247

Patient reported outcomes (PROs) in clinical trials: is 'in-trial' guidance lacking? a systematic review.  

UK PubMed Central (United Kingdom)

BACKGROUND: Patient reported outcomes (PROs) are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on 'in-trial' activity (recruitment, data collection and data inputting) and the management of 'concerning' PRO data (i.e., data which raises concern for the well-being of the trial participant) appears to be lacking. The purpose of this review was to determine the extent and nature of published guidelines addressing these areas. METHODS AND FINDINGS: Systematic review of 1,362 articles identified 18 eligible papers containing 'in-trial' guidelines. Two independent authors undertook a qualitative content analysis of the selected papers. Guidelines presented in each of the articles were coded according to an a priori defined coding frame, which demonstrated reliability (pooled Kappa 0.86-0.97), and validity (<2% residual category coding). The majority of guidelines present were concerned with 'pre-trial' activities (72%), for example, outcome measure selection and study design issues, or 'post-trial' activities (16%) such as data analysis, reporting and interpretation. 'In-trial' guidelines represented 9.2% of all guidance across the papers reviewed, with content primarily focused on compliance, quality control, proxy assessment and reporting of data collection. There were no guidelines surrounding the management of concerning PRO data. CONCLUSIONS: The findings highlight there are minimal in-trial guidelines in publication regarding PRO data collection and management in clinical trials. No guidance appears to exist for researchers involved with the handling of concerning PRO data. Guidelines are needed, which support researchers to manage all PRO data appropriately and which facilitate unbiased data collection.

Kyte DG; Draper H; Ives J; Liles C; Gheorghe A; Calvert M

2013-01-01

248

The generalizability of psychotherapy efficacy trials in major depressive disorder: an analysis of the influence of patient selection in efficacy trials on symptom outcome in daily practice  

Digital Repository Infrastructure Vision for European Research (DRIVER)

Abstract Background Treatment guidelines for major depressive disorder (MDD) are based on results from randomized clinical trials, among others in psychotherapy efficacy trials. However, patients in these trials differ from routine practice patients since trials use stringent criter...

van der Lem Rosalind; de Wever Wouter WH; van der Wee Nic JA; van Veen Tineke; Cuijpers Pim; Zitman Frans G

249

Flaw detection trial using virtual ultrasonic testing  

International Nuclear Information System (INIS)

This report presents features of ultrasonic simulation and aspects to be considered in virtual inspection trials. A simulation trial implementation and results are reported, with main purpose to test different features of the selected simulation software in creation and analysis of a virtual detectability trial. A series of simulations was conducted using simple test block geometry that included notch shaped flaws with varying depths. To make the case realistic, significant structural noise and moderate attenuation were added to the simulation using the material properties settings. The simulation was run using different probe frequency values and crystal dimensions to produce variation in the flaw detectability.The simulated ultrasonic inspection data was analyzed using analysis tools of the used software. The signal-to-noise ratios and locations of the detected indications were characterized and detectability dependence on the notch height was assessed. Also, study about signal-to-noise ratios measured from the detected indications was performed. (orig.)

2010-01-01

250

Traditional multiplicity adjustment methods in clinical trials.  

UK PubMed Central (United Kingdom)

This tutorial discusses important statistical problems arising in clinical trials with multiple clinical objectives based on different clinical variables, evaluation of several doses or regiments of a new treatment, analysis of multiple patient subgroups, etc. Simultaneous assessment of several objectives in a single trial gives rise to multiplicity. If unaddressed, problems of multiplicity can undermine integrity of statistical inferences. The tutorial reviews key concepts in multiple hypothesis testing and introduces main classes of methods for addressing multiplicity in a clinical trial setting. General guidelines for the development of relevant and efficient multiple testing procedures are presented on the basis of application-specific clinical and statistical information. Case studies with common multiplicity problems are used to motivate and illustrate the statistical methods presented in the tutorial, and software implementation of the multiplicity adjustment methods is discussed. Copyright © 2013 John Wiley & Sons, Ltd.

Dmitrienko A; D'Agostino R Sr

2013-09-01

251

[Recent clinical trials of tumor immunotherapy].  

UK PubMed Central (United Kingdom)

Many recent clinical trials of immunotherapy for advanced tumors have reported remarkable results. For example, blockade of cytotoxic T-lymphocyte antigen 4 (CTLA-4) significantly improved median overall survival of melanoma patients. Blockade of programmed cell death 1 (PD-1) or programmed cell death 1 ligand 1 (PD-L1) induced durable tumor regression and prolonged disease stabilization in patients with advanced cancers, including melanoma, non-small-cell lung cancer, and renal cell cancer. In addition, adoptive cell transfer of tumor infiltrating lymphocytes (TILs) and T cells transduced with high avidity T cell receptor (TCR) genes have been reported to elicit marked durable tumor regression in melanoma patients. Further, clinical trials of cancer vaccines targeting various tumors have been conducted to prolong overall survival. In this review, some remarkable results achieved in recent clinical trials are summarized.

Inozume T

2013-01-01

252

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

Science.gov (United States)

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. PMID:23295957

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krleža-Jeri?, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Doré, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2013-02-01

253

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

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

2007-01-01

254

Investigator experiences with financial conflicts of interest in clinical trials.  

UK PubMed Central (United Kingdom)

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

Rochon PA; Sekeres M; Hoey J; Lexchin J; Ferris LE; Moher D; Wu W; Kalkar SR; Van Laethem M; Gruneir A; Gold J; Maskalyk J; Streiner DL; Taback N; Chan AW

2011-01-01

255

Randomized clinical stroke rehabilitation trials in 2005.  

Science.gov (United States)

This article reviews randomized control trials (RCTs) undertaken in stroke rehabilitation in the year 2005. A Medline search generated 31 RCTs in stroke rehabilitation in the year 2005 in the English language. These trials were primarily efficacy studies of a number of treatments: medications such as folate, vitamin B12 and bisphosphonates in preventing osteoporotic related hip fractures, compression stockings in preventing deep vein thrombosis (DVT), use of mechanical robots and positioning of the upper limb to help improve function; and, transcranial magnetic coil stimulation, acupuncture and neural tissue transplant to enhance motor recovery in post-stroke patients. PMID:17191132

Rabadi, Meheroz H

2006-12-27

256

Crowd psychology in South African murder trials.  

UK PubMed Central (United Kingdom)

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

Colman AM

1991-10-01

257

Clinical Trials in Male Hormonal Contraception  

Directory of Open Access Journals (Sweden)

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

Nieschlag E

2011-01-01

258

Photovoltaic domestic field trial. Third annual report  

Energy Technology Data Exchange (ETDEWEB)

An update on a photovoltaics field trial that has been running for four years is presented. The PV Domestic Field Trial was set up to use the design, construction, performance and monitoring of PV units to generate data for utilities, builders and other current and potential users of PVs. Subjects covered were appearance of the systems, architectural integration, fixing methods, cost effectiveness, opinions of users, monitoring and results. During the past 12 months, most of the human effort has gone into collation of data from 22 of the 28 projects. The study was sponsored by Great Britain's DTI.

NONE

2005-07-01

259

Feasibility of Feature-based Indexing, Clustering, and Search of Clinical Trials. A Case Study of Breast Cancer Trials from ClinicalTrials.gov.  

UK PubMed Central (United Kingdom)

Background: When standard therapies fail, clinical trials provide experimental treatment opportunities for patients with drug-resistant illnesses or terminal diseases. Clinical Trials can also provide free treatment and education for individuals who otherwise may not have access to such care. To find relevant clinical trials, patients often search online; however, they often encounter a significant barrier due to the large number of trials and in-effective indexing methods for reducing the trial search space. Objectives: This study explores the feasibility of feature-based indexing, clustering, and search of clinical trials and informs designs to automate these processes. Methods: We decomposed 80 randomly selected stage III breast cancer clinical trials into a vector of eligibility features, which were organized into a hierarchy. We clustered trials based on their eligibility feature similarities. In a simulated search process, manually selected features were used to generate specific eligibility questions to filter trials iteratively. Results: We extracted 1,437 distinct eligibility features and achieved an inter-rater agreement of 0.73 for feature extraction for 37 frequent features occurring in more than 20 trials. Using all the 1,437 features we stratified the 80 trials into six clusters containing trials recruiting similar patients by patient-characteristic features, five clusters by disease-characteristic features, and two clusters by mixed features. Most of the features were mapped to one or more Unified Medical Language System (UMLS) concepts, demonstrating the utility of named entity recognition prior to mapping with the UMLS for automatic feature extraction. Conclusions: It is feasible to develop feature-based indexing and clustering methods for clinical trials to identify trials with similar target populations and to improve trial search efficiency.

Boland MR; Miotto R; Gao J; Weng C

2013-05-01

260

Preclinical trials in autosomal dominant AD: Implementation of the DIAN-TU trial.  

UK PubMed Central (United Kingdom)

The Dominantly Inherited Alzheimer's Network Trials Unit (DIAN-TU) was formed to direct the design and management of interventional therapeutic trials of international DIAN and autosomal dominant Alzheimer's disease (ADAD) participants. The goal of the DIAN-TU is to implement safe trials that have the highest likelihood of success while advancing scientific understanding of these diseases and clinical effects of proposed therapies. The DIAN-TU has launched a trial design that leverages the existing infrastructure of the ongoing DIAN observational study, takes advantage of a variety of drug targets, incorporates the latest results of biomarker and cognitive data collected during the observational study, and implements biomarkers measuring Alzheimer's disease (AD) biological processes to improve the efficiency of trial design. The DIAN-TU trial design is unique due to the sophisticated design of multiple drugs, multiple pharmaceutical partners, academics servings as sponsor, geographic distribution of a rare population and intensive safety and biomarker assessments. The implementation of the operational aspects such as home health research delivery, safety magnetic resonance imagings (MRIs) at remote locations, monitoring clinical and cognitive measures, and regulatory management involving multiple pharmaceutical sponsors of the complex DIAN-TU trial are described.

Mills SM; Mallmann J; Santacruz AM; Fuqua A; Carril M; Aisen PS; Althage MC; Belyew S; Benzinger TL; Brooks WS; Buckles VD; Cairns NJ; Clifford D; Danek A; Fagan AM; Farlow M; Fox N; Ghetti B; Goate AM; Heinrichs D; Hornbeck R; Jack C; Jucker M; Klunk WE; Marcus DS; Martins RN; Masters CM; Mayeux R; McDade E; Morris JC; Oliver A; Ringman JM; Rossor MN; Salloway S; Schofield PR; Snider J; Snyder P; Sperling RA; Stewart C; Thomas RG; Xiong C; Bateman RJ

2013-09-01

 
 
 
 
261

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

Scientific Electronic Library Online (English)

Full Text Available 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 initiative 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 (more) 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.

Grignolo, Alberto

2011-01-01

262

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

Science.gov (United States)

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

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

2013-01-30

263

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

UK PubMed Central (United Kingdom)

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.

Edwards RT; Hounsome B; Linck P; Russell IT

2008-01-01

264

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

UK PubMed Central (United Kingdom)

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

Bookman EB; Din-Lovinescu C; Worrall BB; Manolio TA; Bennett SN; Laurie C; Mirel DB; Doheny KF; Anderson GL; Wehr K; Weinshilboum R; Chen DT

2013-01-01

265

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.

Edwards Rhiannon T; Hounsome Barry; Linck Pat; Russell Ian T

2008-01-01

266

Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov.  

UK PubMed Central (United Kingdom)

IMPORTANCE: Clinical trials are essential to cancer care, and data about the current state of research in oncology are needed to develop benchmarks and set the stage for improvement. OBJECTIVE: To perform a comprehensive analysis of the national oncology clinical research portfolio. DESIGN: All interventional clinical studies registered on ClinicalTrials.gov between October 2007 and September 2010 were identified using Medical Subject Heading terms and submitted conditions. They were reviewed to validate classification, subcategorized by cancer type, and stratified by design characteristics to facilitate comparison across cancer types and with other specialties. RESULTS: Of 40 970 interventional studies registered between October 2007 and September 2010, a total of 8942 (21.8%) focused on oncology. Compared with other specialties, oncology trials were more likely to be single arm (62.3% vs 23.8%; P < .001), open label (87.8% vs 47.3%; P < .001), and nonrandomized (63.9% vs 22.7%; P < .001). There was moderate but significant correlation between number of trials conducted by cancer type and associated incidence and mortality (Spearman rank correlation coefficient, 0.56 [P = .04] and 0.77 [P = .001], respectively). More than one-third of all oncology trials were conducted solely outside North America. CONCLUSIONS AND RELEVANCE: There are significant variations between clinical trials in oncology and other diseases, as well as among trials within oncology. The differences must be better understood to improve both the impact of cancer research on clinical practice and the use of constrained resources.

Hirsch BR; Califf RM; Cheng SK; Tasneem A; Horton J; Chiswell K; Schulman KA; Dilts DM; Abernethy AP

2013-06-01

267

Dialogues on diversifying clinical trials: successful strategies for engaging women and minorities in clinical trials.  

UK PubMed Central (United Kingdom)

There is mounting scientific evidence pointing to genetic or physiologic distinctions between genders and among racial and ethnic groups that influence disease risk and severity and response to treatment. The diverse enrollment of subjects engaged in clinical trials research is, thus, critical to developing safer and more effective drugs and medical devices. However, in the United States, there are striking disparities in clinical trial participation. To address this problem, the Food and Drug Administration (FDA) Office of Women's Health and the Society for Women's Health Research (SWHR) together convened the 2-day meeting, Dialogues on Diversifying Clinical Trials. The conference was held in Washington, DC, on September 22-23, 2011, and brought together a wide range of speakers from clinical research, industry, and regulatory agencies. Here, we present the major findings discussed at this meeting about female and minority patients and physicians and their willingness to participate in clinical trials and the barriers that sponsors face in recruiting a diverse trial population. We also discuss some recommendations for improving trial diversity through new technologies and greater efficiency in trial regulation and review.

Coakley M; Fadiran EO; Parrish LJ; Griffith RA; Weiss E; Carter C

2012-07-01

268

Preclinical trials in autosomal dominant AD: Implementation of the DIAN-TU trial.  

Science.gov (United States)

The Dominantly Inherited Alzheimer's Network Trials Unit (DIAN-TU) was formed to direct the design and management of interventional therapeutic trials of international DIAN and autosomal dominant Alzheimer's disease (ADAD) participants. The goal of the DIAN-TU is to implement safe trials that have the highest likelihood of success while advancing scientific understanding of these diseases and clinical effects of proposed therapies. The DIAN-TU has launched a trial design that leverages the existing infrastructure of the ongoing DIAN observational study, takes advantage of a variety of drug targets, incorporates the latest results of biomarker and cognitive data collected during the observational study, and implements biomarkers measuring Alzheimer's disease (AD) biological processes to improve the efficiency of trial design. The DIAN-TU trial design is unique due to the sophisticated design of multiple drugs, multiple pharmaceutical partners, academics servings as sponsor, geographic distribution of a rare population and intensive safety and biomarker assessments. The implementation of the operational aspects such as home health research delivery, safety magnetic resonance imagings (MRIs) at remote locations, monitoring clinical and cognitive measures, and regulatory management involving multiple pharmaceutical sponsors of the complex DIAN-TU trial are described. PMID:24016464

Mills, S M; Mallmann, J; Santacruz, A M; Fuqua, A; Carril, M; Aisen, P S; Althage, M C; Belyew, S; Benzinger, T L; Brooks, W S; Buckles, V D; Cairns, N J; Clifford, D; Danek, A; Fagan, A M; Farlow, M; Fox, N; Ghetti, B; Goate, A M; Heinrichs, D; Hornbeck, R; Jack, C; Jucker, M; Klunk, W E; Marcus, D S; Martins, R N; Masters, C M; Mayeux, R; McDade, E; Morris, J C; Oliver, A; Ringman, J M; Rossor, M N; Salloway, S; Schofield, P R; Snider, J; Snyder, P; Sperling, R A; Stewart, C; Thomas, R G; Xiong, C; Bateman, R J

2013-09-06

269

Sample size requirements in trials using repeated measurements and the impact of trial design.  

UK PubMed Central (United Kingdom)

OBJECTIVE: Sample size calculations for clinical trials generally use expected changes between groups, and variances obtained from the literature. However, this approach neglects the impact of differences in trial design. We studied the effects of variations in trial design on the required sample size. METHODS: Data were used from the METEOR (Measuring Effects on Intima-Media Thickness: an Evaluation of Rosuvastatin) trial in which carotid intima-media thickness (CIMT) measurements were performed twice at baseline, at 6, 12 and 18 months, and twice at the end of 2-year study treatment. A sample size formula for continuous outcome measures that incorporates between- and within-individual variance components was used to evaluate the impact of differences in the length of follow-up, and the number of CIMT examinations. RESULTS: Trial designs with a shorter duration of follow-up have increased within-individual variance and require larger sample sizes to detect the same treatment effect. Reduction in the number of examinations within a trial with a given duration, i.e. by using single rather than duplicate baseline and end-of-study scans or by not performing intermediate scans, also increased the required sample size to maintain the same power. CONCLUSION: A longer trial duration and/or more frequent examinations within a trial which has repeated measures of an outcome variable substantially increase study power and reduce the required sample size. In situations where the costs of recruiting, retaining and examining individual participants are known, the sample size, study length and number of examinations can be balanced to optimize the trial design relative to costs or other study objectives.

Peters SA; Palmer MK; den Ruijter HM; Grobbee DE; Crouse JR 3rd; O'Leary DH; Evans GW; Raichlen JS; Bots ML

2012-05-01

270

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

Directory of Open Access Journals (Sweden)

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

Lutje Vittoria; Gerritsen Annette; Siegfried Nandi

2011-01-01

271

Clinical trial registration system and evidence-based medicine  

Directory of Open Access Journals (Sweden)

Full Text Available ABSTRACT: The authors briefly introduced the management of clinical test for new drug development, clinical trials for drugs prepared in hospital and post-market drugs, and other types of clinical trials. The mechanism of WHO International Clinical Trial Register Platform (WHO ICTRP), Chinese Clinical Trial Register (ChiCTR) and Chinese Clinical Trial Registration and Publishing Collaboration (ChiCTRPC) were also introduced. The authors suggested the trialists to practice the basic philosophy of evidence-based medicine as the rules of their thought and action, and considered that this is the inner guarantee system for the validity of clinical trials.

Tai-xiang WU

2007-01-01

272

Double PPH Technique for Hemorrhoidal Prolapse: A Multicentric, Prospective, and Nonrandomized Trial.  

UK PubMed Central (United Kingdom)

Introduction. Longo's technique (or PPH technique) is well known worldwide. Meta-analysis suggests that the failure due to persistence or recurrence is close to 7.7%. One of the reasons for the recurrence is the treatment of the advanced hemorrhoidal prolapse with a single stapling device, which is not enough to resect the appropriate amount of prolapse. Materials and methods. We describe the application of "Double PPH Technique" (D-PPH) to treat large hemorrhoidal prolapses. We performed a multicentric, prospective, and nonrandomized trial from July 2008 to July 2009, wherein 2 groups of patients with prolapse and hemorrhoids were treated with a single PPH or a D-PPH. Results were compared. The primary outcome was evaluation of safety and efficacy of the D-PPH procedure in selected patients with large hemorrhoidal prolapse. Results. In all, 281 consecutive patients suffering from hemorrhoidal prolapse underwent surgery, of whom 74 were assigned intraoperatively to D-PPH, whereas 207 underwent single PPH. Postoperative complications were 5% in both groups (P = .32), in particular: postoperative major bleeding 3.0% in PPH versus 4.1% D-PPH (P = .59); pain 37.9 % PPH versus 27.3% D-PPH (mean visual analog scale [VAS] = 2.5 vs 2.9, respectively; P = .72); and fecal urgency 2.1% PPH versus 5.7% D-PPH (P = .8). Persistence of hemorrhoidal prolapse at 12-month follow-up was 3.7% in the PPH group versus 5.9% in the D-PPH group (P = .5). Conclusions. Our data support the hypothesis that an accurate intraoperative patient selection for single (PPH) or double (D-PPH) stapled technique will lower in a significant way the incidence of recurrence after Longo's procedure for hemorrhoidal prolapse.

Braini A; Narisetty P; Favero A; Calandra S; Calandra A; Caponnetto F; Digito F; Da Pozzo F; Marcotti E; Porebski E; Rovedo S; Terrosu G; Torricelli L; Stuto A

2013-01-01

273

Developing regulatory-compliant electronic case report forms for clinical trials: experience with the demand trial.  

UK PubMed Central (United Kingdom)

The use of electronic case report forms (CRF) to gather data in randomized clinical trials has grown to progressively replace paper-based forms. Computerized form designs must ensure the same data quality expected of paper CRF, by following Good Clinical Practice rules. Electronic data capture (EDC) tools must also comply with applicable statutory and regulatory requirements. Here the authors focus on the development of computerized systems for clinical trials implementing FDA and EU recommendations and regulations, and describe a laptop-based electronic CRF used in a randomized, multicenter clinical trial.

Ene-Iordache B; Carminati S; Antiga L; Rubis N; Ruggenenti P; Remuzzi G; Remuzzi A

2009-05-01

274

Developing regulatory-compliant electronic case report forms for clinical trials: experience with the demand trial.  

Science.gov (United States)

The use of electronic case report forms (CRF) to gather data in randomized clinical trials has grown to progressively replace paper-based forms. Computerized form designs must ensure the same data quality expected of paper CRF, by following Good Clinical Practice rules. Electronic data capture (EDC) tools must also comply with applicable statutory and regulatory requirements. Here the authors focus on the development of computerized systems for clinical trials implementing FDA and EU recommendations and regulations, and describe a laptop-based electronic CRF used in a randomized, multicenter clinical trial. PMID:19261946

Ene-Iordache, Bogdan; Carminati, Sergio; Antiga, Luca; Rubis, Nadia; Ruggenenti, Piero; Remuzzi, Giuseppe; Remuzzi, Andrea

2009-03-04

275

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

UK PubMed Central (United Kingdom)

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

Kepplinger J; Barlinn K; Kolieskova S; Bavarsad Shahripour R; Pallesen LP; Schrempf W; Graehlert X; Schwanebeck U; Sisson A; Zerna C; Puetz V; Reichmann H; Albright KC; Alexandrov AW; Vosko M; Mikulik R; Bodechtel U; Alexandrov AV

2013-08-01

276

A Bayesian Shrinkage Model for Incomplete Longitudinal Binary Data with Application to the Breast Cancer Prevention Trial.  

Science.gov (United States)

We consider inference in randomized longitudinal studies with missing data that is generated by skipped clinic visits and loss to follow-up. In this setting, it is well known that full data estimands are not identified unless unverified assumptions are imposed. We assume a non-future dependence model for the drop-out mechanism and partial ignorability for the intermittent missingness. We posit an exponential tilt model that links non-identifiable distributions and distributions identified under partial ignorability. This exponential tilt model is indexed by non-identified parameters, which are assumed to have an informative prior distribution, elicited from subject-matter experts. Under this model, full data estimands are shown to be expressed as functionals of the distribution of the observed data. To avoid the curse of dimensionality, we model the distribution of the observed data using a Bayesian shrinkage model. In a simulation study, we compare our approach to a fully parametric and a fully saturated model for the distribution of the observed data. Our methodology is motivated by, and applied to, data from the Breast Cancer Prevention Trial. PMID:21516191

Wang, C; Daniels, M J; Scharfstein, D O; Land, S

2010-12-01

277

Improvement of hospital care for patients with non-Hodgkin's lymphoma: protocol for a cluster randomized controlled trial (PEARL study).  

UK PubMed Central (United Kingdom)

BACKGROUND: Malignant lymphomas constitute a diverse group of cancers of lymphocytes. One well-known disease is Hodgkin's lymphoma; the others are classified as non-Hodgkin's lymphoma (NHL). NHLs are the most common hematologic neoplasms in adults worldwide, and in 2012 over 170,000 new cases were estimated in the United States and Europe.In previous studies, several practice gaps in hospital care for patients with NHL have been identified. To decrease this variation in care, the present study aims to perform a problem analysis in which barriers to and facilitators for optimal NHL care will be identified and, based on these findings, to develop (tailored) improvement strategies. Subsequently, we will assess the effectiveness, feasibility and costs of the improvement strategies. METHODS/DESIGN: Barriers and facilitators will be explored using the literature, using interviews and questionnaires among physicians involved in NHL care, and patients diagnosed with NHL. The results will be used to develop a tailored improvement strategy. A cluster randomized controlled trial involving 19 Dutch hospitals will be conducted. Hospitals will be randomized to receive either an improvement strategy tailored to the barriers and facilitators found or, a standard strategy of audit and feedback.The effects of both strategies will be evaluated using previously developed quality indicators. Adherence to the indicators will be measured before and after the intervention period based on medical records from newly diagnosed NHL patients. To study the feasibility of both strategies, a process evaluation will be additionally performed. Data about exposure to the different elements of the strategies will be collected using questionnaires. Economic evaluation from a healthcare perspective will compare the two implementation strategies, where the costs of the implementation strategy and changes in healthcare consumption will be assessed. DISCUSSION: The presence of variation in the use of diagnostic tests, treatment, and follow-up between different physicians in different hospitals in the Netherlands is important for patients. To reduce the existing variation in care, implementation of tailored interventions to improve NHL care is necessary. TRIAL REGISTRATION: This trial is registered at ClinicalTrial.gov as the PEARL study, registration number NCT01562509.

Stienen JJ; Hermens RP; Wennekes L; van de Schans SA; Dekker HM; Blijlevens NM; van der Maazen RW; Adang EM; van Krieken JH; Ottevanger PB

2013-01-01

278

Eligibility criteria in knee osteoarthritis clinical trials: systematic review.  

Science.gov (United States)

There is an increasing concern over generalizability of trial results. We investigated eligibility criteria of knee osteoarthritis clinical trials. Eligible trials were randomized, placebo-controlled trials that were identified by searches in MEDLINE, SCOPUS, and the Cochrane Central Register of Controlled Trials. We then attempted to extract data on the eligibility criteria by employing predetermined criteria. From 355 randomized knee osteoarthritis trials, we reviewed data categorized by non-osteoarthritis-related and osteoarthritis-related factors. A variety of items were used in the eligibility criteria. Regarding the non-osteoarthritis-related factors, ethical considerations, such as inability to give an informed consent (79.4 %) or medical conditions potential for risks by test treatments (56.0 %) or by participation in a trial (57.2 %), were the common reasons for excluding patients from a trial. Concerning the osteoarthritis-related factors, most of the trials did not specify age and symptom severity. When trials specifying these items were investigated, patients with 40 to 80 years in age and grade 2 in the Kellgren-Lawrence scale were mostly included into a trial. For the pain intensity, patients with ?20-40 in the 100-mm visual analog scale and ?6-8 in the WOMAC pain subscale were commonly enrolled into a trial. These findings warrant further investigation on the generalizability of trial results. PMID:23877490

Koog, Yun Hyung; Wi, Hyungsun; Jung, Won Young

2013-07-23

279

Clinical Trials : Growing Opportunities for India  

Directory of Open Access Journals (Sweden)

Full Text Available The US$65-billion (in 2005), global R&D pie is expected to grow to US$l00-billion by 2010. If India secures even a small share of this, it could grow 2-billion business.Thus, pharmaceutical R&D, whether outsourcing or indigenous, is likely to emerge as a multi­billion dollar industry, including contract research and manufacturing, clinical trials, etc. Indian clinical trials market in 2006 was US$ 140million and is growing at a CAGR of 40% for the last 3 years. India is fast emerging as a favoured destination for clinical trials outsourcing, in view of the country's advantages like large pool of patients, faster patient recruitment, well trained English speaking physicians and IPR (Intellectual property rights) protection, besides lower labour costs. Over 100 pharmaceutical companies, including big multinationals such as Pfizer and Merck, are currently outsourcing clinical trials in the country. Also, there is an increased awareness regarding ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) guidelines for conduct of clinical research. Besides, India's inherent advantage in IT skills helped in outsourcing of high-end activities like data management.

Dayanidhi Behera; Amol Shindikar

2008-01-01

280

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 ...

Heinemann, Lutz

 
 
 
 
281

Winding trials for ITER toroidal filed coils  

International Nuclear Information System (INIS)

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

2012-01-01

282

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.

283

Randomized Clinical Stroke Trials in 2007  

Digital Repository Infrastructure Vision for European Research (DRIVER)

This article reviews the randomized control trials (RCT’s) that were published in 2007 of emerging pharmacotherapies in patients with acute (? 2 weeks), sub-acute (2 to 12 weeks) and chronic (? 12 weeks) stroke. A Medline search generated 22 RCT’s in stroke in the year 2007 in the English language. ...

Rabadi, Meheroz H; Blass, John P

284

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 ...

Ragaa H.M. Salama

285

Trials show delayed recurrence in ovarian cancer.  

UK PubMed Central (United Kingdom)

Phase I trials of 2 treatments for recurrent ovarian cancer-a 2-step immunotherapy treatment and an antibody-drug conjugate-demonstrated promising early results in delaying recurrence, in work presented at the American Association for Cancer Research Annual Meeting 2013.

Bender E

2013-06-01

286

Partnership brings clinical trials to communities.  

UK PubMed Central (United Kingdom)

The Leukemia & Lymphoma Society and Dana-Farber Cancer Institute have formed the Blood Cancer Research Partnership, designed to bring innovative clinical trials to community practices. Organizers say this will help studies accrue more patients and give more patients access to investigational therapies.

2013-08-01

287

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.

288

The SYNERGY trial: study design and rationale.  

UK PubMed Central (United Kingdom)

BACKGROUND: Enoxaparin was shown to be superior to unfractionated heparin in the patients with non-ST-segment elevation acute coronary syndromes (ACS) in the Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-wave Coronary Events study and the Thrombolysis In Myocardial Infarction (TIMI) 11B trial. However, enoxaparin has had limited acceptance in clinical practice, in part because of the contemporary management of these patients, which includes glycoprotein IIb/IIIa inhibition and the use of early invasive management strategies. STUDY DESIGN: The Superior Yield of the New strategy of Enoxaparin, Revascularization and GlYcoprotein IIb/IIIa inhibitors (SYNERGY) trial is an 8000-patient, prospective, randomized, open-label, multicenter investigation of enoxaparin compared with unfractionated heparin in patients at high risk with non-ST-segment elevation ACS treated with an early invasive strategy. The primary efficacy end point is death or nonfatal myocardial infarction 30 days after enrollment. IMPLICATIONS: The SYNERGY trial is the largest study currently planned for the acute therapy of patients with non-ST-segment elevation ACS and the first large trial since the publication of the revised American College of Cardiology/American Heart Association guidelines for the management of these patients. In addition to evaluating the potential superiority of enoxaparin over unfractionated heparin, this investigation will provide important observations of current treatment strategies in patients with ACS.

2002-06-01

289

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

UK PubMed Central (United Kingdom)

The stimulatory effects of testosterone on erythropoiesis are very well known, but the mechanisms underlying the erythropoietic action of testosterone are still poorly understood, although erythropoietin has long been considered a potential mediator. A total of 108 healthy men >65 years old with serum testosterone concentration <475 ng/dL were recruited by direct mailings to alumni of the University of Pennsylvania and Temple University, and randomized to receive a 60-cm(2) testosterone or placebo patch for 36 months. Ninety-six subjects completed the trial. We used information and stored serum specimens from this trial to test the hypothesis that increasing testosterone increases haemoglobin by stimulating erythropoietin production. We used information of 67 men, 43 in the testosterone group and 24 in the placebo group who had banked specimens available for assays of testosterone, haemoglobin and erythropoietin at baseline and after 36 months. The original randomized clinical study was primarily designed to verify the effects of testosterone on bone mineral density. The primary outcome of this report was to investigate whether or not transdermal testosterone increases haemoglobin by increasing erythropoietin levels. The mean age ± SD of the 67 subjects at baseline was 71.8 ± 4.9 years. Testosterone replacement therapy for 36 months, as compared with placebo, induced a significant increase in haemoglobin (0.86 ± 0.31 g/dL, p = 0.01), but no change in erythropoietin levels (-0.24 ± 2.16 mIU/mL, p = 0.91). Included time-varying measure of erythropoietin did not significantly account for the effect of testosterone on haemoglobin (Treatment-by-time: ? = 0.93, SE = 0.33, p = 0.01). No serious adverse effect was observed. Transdermal testosterone treatment of older men for 36 months significantly increased haemoglobin, but not erythropoietin levels. The haematopoietic effect of testosterone does not appear to be mediated by stimulation of erythropoietin production.

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

2013-01-01

290

The established status epilepticus trial 2013.  

UK PubMed Central (United Kingdom)

Benzodiazepine-refractory status epilepticus (established status epilepticus, ESE) is a relatively common emergency condition with several widely used treatments. There are no controlled, randomized, blinded clinical trials to compare the efficacy and tolerability of currently available treatments for ESE. The ESE treatment trial is designed to determine the most effective and/or the least effective treatment of ESE among patients older than 2 years by comparing three arms: fosphenytoin (fPHT) levetiracetam (LVT), and valproic acid (VPA). This is a multicenter, randomized, double-blind, Bayesian adaptive, phase III comparative effectiveness trial. Up to 795 patients will be randomized initially 1:1:1, and response-adaptive randomization will occur after 300 patients have been recruited. Randomization will be stratified by three age groups, 2-18, 19-65, and 66 and older. The primary outcome measure is cessation of clinical seizure activity and improving mental status, without serious adverse effects or further intervention at 60 min after administration of study drug. Each subject will be followed until discharge or 30 days from enrollment. This trial will include interim analyses for early success and futility. This trial will be considered a success if the probability that a treatment is the most effective is >0.975 or the probability that a treatment is the least effective is >0.975 for any treatment. Proposed total sample size is 795, which provides 90% power to identify the most effective and/or the least effective treatment when one treatment arm has a true response rate of 65% and the true response rate is 50% in the other two arms.

Bleck T; Cock H; Chamberlain J; Cloyd J; Connor J; Elm J; Fountain N; Jones E; Lowenstein D; Shinnar S; Silbergleit R; Treiman D; Trinka E; Kapur J

2013-09-01

291

The established status epilepticus trial 2013.  

Science.gov (United States)

Benzodiazepine-refractory status epilepticus (established status epilepticus, ESE) is a relatively common emergency condition with several widely used treatments. There are no controlled, randomized, blinded clinical trials to compare the efficacy and tolerability of currently available treatments for ESE. The ESE treatment trial is designed to determine the most effective and/or the least effective treatment of ESE among patients older than 2 years by comparing three arms: fosphenytoin (fPHT) levetiracetam (LVT), and valproic acid (VPA). This is a multicenter, randomized, double-blind, Bayesian adaptive, phase III comparative effectiveness trial. Up to 795 patients will be randomized initially 1:1:1, and response-adaptive randomization will occur after 300 patients have been recruited. Randomization will be stratified by three age groups, 2-18, 19-65, and 66 and older. The primary outcome measure is cessation of clinical seizure activity and improving mental status, without serious adverse effects or further intervention at 60 min after administration of study drug. Each subject will be followed until discharge or 30 days from enrollment. This trial will include interim analyses for early success and futility. This trial will be considered a success if the probability that a treatment is the most effective is >0.975 or the probability that a treatment is the least effective is >0.975 for any treatment. Proposed total sample size is 795, which provides 90% power to identify the most effective and/or the least effective treatment when one treatment arm has a true response rate of 65% and the true response rate is 50% in the other two arms. PMID:24001084

Bleck, Thomas; Cock, Hannah; Chamberlain, James; Cloyd, James; Connor, Jason; Elm, Jordan; Fountain, Nathan; Jones, Elizabeth; Lowenstein, Daniel; Shinnar, Shlomo; Silbergleit, Robert; Treiman, David; Trinka, Eugen; Kapur, Jaideep

2013-09-01

292

[Legislative frame and clinical trials in Lebanon].  

UK PubMed Central (United Kingdom)

UNLABELLED: In Lebanon, as in other developing countries, most of the clinical trials are achieved without considering any rule adopted in the industrialized countries, which causes serious ethical problems. This study aims to review the different Lebanese texts related to clinical trials in order to show the existing legislative frame, and to formulate suggestions that help the legislator defining better this activity. We reviewed and analyzed the Lebanese legislation related to the clinical trials especially the Lebanese law project about "therapeutic trials on human subjects" and conducted semi-directive interviews with actors from the society. RESULTS: We noticed a legislative gap in this domain, highlighting the fragility of the social link in the health domain, and reverberating negatively on the physician/physician, physician/hospital, physician/industrial and industrial/hospital relationships, in addition to many gaps affecting the skills of physicians-investigators. In spite of the promising institutional effort, the national frame of clinical trials does not seem to be sufficient regarding the ignorance of applied legislative texts, the industrial promoter's weight, and the pressures. This is applied to the absence of a powerful national coordinator, the inexistence of a pharmacovigilance system or a skillful authority for the sanitary security of health products, and the confusion in the concepts of medical ethics and deontology. In conclusion were presented for achieving improvements on many levels: an objective criticism of the law project proposed in 2002 followed by a call to review its content and improve it in order to reach an instructive and applicable global legislation ; an action that can be realized only through educating adequately the investigators, and informing the large public in order to guide the governors towards a legislation allowing people in Lebanon to "live well " with complete dignity.

Abou-Mrad F

2010-09-01

293

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

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

2009-01-01

294

The Radiation oncology practice standards trial  

International Nuclear Information System (INIS)

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

2010-01-01

295

Novel ocular antihypertensive compounds in clinical trials  

Directory of Open Access Journals (Sweden)

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

Chen J; Runyan SA; Robinson MR

2011-01-01

296

Impact and costs of incentives to reduce attrition in online trials: two randomized controlled trials.  

UK PubMed Central (United Kingdom)

BACKGROUND: Attrition from follow-up is a major methodological challenge in randomized trials. Incentives are known to improve response rates in cross-sectional postal and online surveys, yet few studies have investigated whether they can reduce attrition from follow-up in online trials, which are particularly vulnerable to low follow-up rates. OBJECTIVES: Our objective was to determine the impact of incentives on follow-up rates in an online trial. METHODS: Two randomized controlled trials were embedded in a large online trial of a Web-based intervention to reduce alcohol consumption (the Down Your Drink randomized controlled trial, DYD-RCT). Participants were those in the DYD pilot trial eligible for 3-month follow-up (study 1) and those eligible for 12-month follow-up in the DYD main trial (study 2). Participants in both studies were randomly allocated to receive an offer of an incentive or to receive no offer of an incentive. In study 1, participants in the incentive arm were randomly offered a £5 Amazon.co.uk gift voucher, a £5 charity donation to Cancer Research UK, or entry in a prize draw for £250. In study 2, participants in the incentive arm were offered a £10 Amazon.co.uk gift voucher. The primary outcome was the proportion of participants who completed follow-up questionnaires in the incentive arm(s) compared with the no incentive arm. RESULTS: In study 1 (n = 1226), there was no significant difference in response rates between those participants offered an incentive (175/615, 29%) and those with no offer (162/611, 27%) (difference = 2%, 95% confidence interval [CI] -3% to 7%). There was no significant difference in response rates among the three different incentives offered. In study 2 (n = 2591), response rates were 9% higher in the group offered an incentive (476/1296, 37%) than in the group not offered an incentive (364/1295, 28%) (difference = 9%, 95% CI 5% to 12%, P < .001). The incremental cost per extra successful follow-up in the incentive arm was £110 in study 1 and £52 in study 2. CONCLUSION: Whereas an offer of a £10 Amazon.co.uk gift voucher can increase follow-up rates in online trials, an offer of a lower incentive may not. The marginal costs involved require careful consideration. TRIAL REGISTRATION: ISRCTN31070347; http://www.controlled-trials.com/ISRCTN31070347 (Archived by WebCite at http://www.webcitation.org/5wgr5pl3s).

Khadjesari Z; Murray E; Kalaitzaki E; White IR; McCambridge J; Thompson SG; Wallace P; Godfrey C

2011-01-01

297

Publication bias in clinical trials due to statistical significance or direction of trial results.  

UK PubMed Central (United Kingdom)

BACKGROUND: The tendency for authors to submit, and of journals to accept, manuscripts for publication based on the direction or strength of the study findings has been termed publication bias. OBJECTIVES: To assess the extent to which publication of a cohort of clinical trials is influenced by the statistical significance, perceived importance, or direction of their results. SEARCH STRATEGY: We searched the Cochrane Methodology Register (The Cochrane Library [Online] Issue 2, 2007), MEDLINE (1950 to March Week 2 2007), EMBASE (1980 to Week 11 2007) and Ovid MEDLINE In-Process & Other Non-Indexed Citations (March 21 2007). We also searched the Science Citation Index (April 2007), checked reference lists of relevant articles and contacted researchers to identify additional studies. SELECTION CRITERIA: Studies containing analyses of the association between publication and the statistical significance or direction of the results (trial findings), for a cohort of registered clinical trials. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data. We classified findings as either positive (defined as results classified by the investigators as statistically significant (P < 0.05), or perceived as striking or important, or showing a positive direction of effect) or negative (findings that were not statistically significant (P >/= 0.05), or perceived as unimportant, or showing a negative or null direction in effect). We extracted information on other potential risk factors for failure to publish, when these data were available. MAIN RESULTS: Five studies were included. Trials with positive findings were more likely to be published than trials with negative or null findings (odds ratio 3.90; 95% confidence interval 2.68 to 5.68). This corresponds to a risk ratio of 1.78 (95% CI 1.58 to 1.95), assuming that 41% of negative trials are published (the median among the included studies, range = 11% to 85%). In absolute terms, this means that if 41% of negative trials are published, we would expect that 73% of positive trials would be published.Two studies assessed time to publication and showed that trials with positive findings tended to be published after four to five years compared to those with negative findings, which were published after six to eight years. Three studies found no statistically significant association between sample size and publication. One study found no significant association between either funding mechanism, investigator rank, or sex and publication. AUTHORS' CONCLUSIONS: Trials with positive findings are published more often, and more quickly, than trials with negative findings.

Hopewell S; Loudon K; Clarke MJ; Oxman AD; Dickersin K

2009-01-01

298

Statistical and methodological issues in microbicide trial design.  

UK PubMed Central (United Kingdom)

Microbicide trials aim to measure the effect of a microbicide in reducing the risk of acquiring human immunodeficiency virus. Such trials present a number of challenging issues from design and conduct through to analysis and reporting. This begins with the initial identification of the target trial population. Prevention trials need to identify those at risk of human immunodeficiency virus infection. This can be more difficult in the general population compared with treatment trials that can target specific patient groups who have a confirmed diagnosis of the disease of interest. Consequently, microbicide trial participants will inevitably be recruited who are never at risk of HIV infection. In this chapter we outline the main features of microbicide trial design, key issues during conduct and analysis, and discuss the challenges specific to these types of clinical trials.

Crook AM; Nunn AJ

2012-08-01

299

Q&A: Eric Winer on neoadjuvant clinical trials.  

UK PubMed Central (United Kingdom)

Eric Winer, MD, professor of medicine at Harvard Medical School and director of the Breast Oncology Center at Dana-Farber Cancer Institute, discusses presurgical trials for breast cancer and the roles such trials may eventually play in drug approvals.

Winer E

2013-08-01

300

Hepatitis B Clinical Trials: What You Need to Know  

Science.gov (United States)

Hepatitis B Clinical Trials What You Need To Know There are several promising new drugs that are being ... I learn more about specific clinical trials for hepatitis B? First, talk to your doctor. If he or ...

 
 
 
 
301

Plant Growth Regulator Trials on Spring and Winter Barley.  

Science.gov (United States)

The present report encompasses trials conducted by the Scottish Agricultural Colleges on spring barley from 1980-82 and winter barley from 1979-82. The growth regulators assessed in the trials were: ethephon + mepiquat chloride (Terpal), ethephon (Cerone)...

W. G. W. Paterson G. A. Blackett W. D. Gill

1983-01-01

302

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

Directory of Open Access Journals (Sweden)

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

Walach Harald; Sadaghiani Catarina; Dehm Cornelia; Bierman Dick

2005-01-01

303

Mislabeling controlled clinical trials (CCTs) as "randomized clinical trials (RCTs)" in dental specialty journals.  

UK PubMed Central (United Kingdom)

OBJECTIVES: This study aimed to investigate whether studies published in dental journals with the highest impact factor, representing the 5 major dental specialties and titled as randomized clinical trials (RCTs) are truly RCTs. A second objective was to explore the association of journal type and other publication characteristics on correct classification. METHODS: The American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), the British Journal of Oral and Maxillofacial Surgery (BJOMS), the International Journal of Prosthodontics (IJP), the Journal of Clinical Periodontology (JCP), and the Journal of Endodontics (JOE) were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed using descriptive statistics, and univariable and multivariable examination of statistical associations via ordinal logistic regression modeling (proportional odds model). RESULTS: A total of 222 trials were identified. From the included trials, 88 (39.64%) were considered to be RCTs, 107 (48.20%) were considered to be of unclear status, and 27 (12.16%) were not considered as RCTs. In the multivariable analysis among the included variables, journal type, involvement of statistician, year of publication, multicenter trial, and number of authors were significant predictors of correctly classifying a study as an RCT versus no RCT and of unclear status. CONCLUSIONS: This study indicates the need for clear and accurate reporting of clinical trials and the need for educating investigators on RCT methodology.

Koletsi D; Pandis N; Polychronopoulou A; Eliades T

2012-09-01

304

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

Directory of Open Access Journals (Sweden)

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

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

2011-01-01

305

Electronic search strategies to identify reports of cluster randomized trials in MEDLINE: low precision will improve with adherence to reporting standards  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Cluster randomized trials (CRTs) present unique methodological and ethical challenges. Researchers conducting systematic reviews of CRTs (e.g., addressing methodological or ethical issues) require efficient electronic search strategies (filters or hedges) to identify trials in electronic databases such as MEDLINE. According to the CONSORT statement extension to CRTs, the clustered design should be clearly identified in titles or abstracts; however, variability in terminology may make electronic identification challenging. Our objectives were to (a) evaluate sensitivity ("recall") and precision of a well-known electronic search strategy ("randomized controlled trial" as publication type) with respect to identifying CRTs, (b) evaluate the feasibility of new search strategies targeted specifically at CRTs, and (c) determine whether CRTs are appropriately identified in titles or abstracts of reports and whether there has been improvement over time. Methods We manually examined a wide range of health journals to identify a gold standard set of CRTs. Search strategies were evaluated against the gold standard set, as well as an independent set of CRTs included in previous systematic reviews. Results The existing strategy (randomized controlled trial.pt) is sensitive (93.8%) for identifying CRTs, but has relatively low precision (9%, number needed to read 11); the number needed to read can be halved to 5 (precision 18.4%) by combining with cluster design-related terms using the Boolean operator AND; combining with the Boolean operator OR maximizes sensitivity (99.4%) but would require 28.6 citations read to identify one CRT. Only about 50% of CRTs are clearly identified as cluster randomized in titles or abstracts; approximately 25% can be identified based on the reported units of randomization but are not amenable to electronic searching; the remaining 25% cannot be identified except through manual inspection of the full-text article. The proportion of trials clearly identified has increased from 28% between the years 2000-2003, to 60% between 2004-2007 (absolute increase 32%, 95% CI 17 to 47%). Conclusions CRTs should include the phrase "cluster randomized trial" in titles or abstracts; this will facilitate more accurate indexing of the publication type by reviewers at the National Library of Medicine, and efficient textword retrieval of the subset employing cluster randomization.

Taljaard Monica; McGowan Jessie; Grimshaw Jeremy M; Brehaut Jamie C; McRae Andrew; Eccles Martin P; Donner Allan

2010-01-01

306

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 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, os espectadores do julgamento e o público mais amplo. O desenvolvimento da cirurgia ginecológica alterou as relações entre médico e paciente, permitindo que mulheres po (more) bres 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 bodies and gynecological disease for female patients, trial spectators, and the larger public. It suggests that the development of gynecological surgery altered doctor-patient r (more) elationships 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.

Morantz-Sanchez, Regina

2005-06-01

307

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  

Directory of Open Access Journals (Sweden)

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

2005-01-01

308

Key Issues in the Reporting of Trial Information at ...  

Science.gov (United States)

Text VersionPage 1. 1 Key Issues in the Reporting of Trial Information at ClinicalTrials.gov ... Editors Funders 6 Page 7. Summary of Key Points • ClinicalTrials.gov ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

309

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 ch...

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

310

Randomization in substance abuse clinical trials  

Directory of Open Access Journals (Sweden)

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

Hedden Sarra L; Woolson Robert F; Malcolm Robert J

2006-01-01

311

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.

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

2005-01-01

312

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

Science.gov (United States)

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

313

Economic analysis of secondary trial data.  

UK PubMed Central (United Kingdom)

Clinical trials may furnish data to conduct economic analyses. An economic analysis requires us to identify all opportunity costs associated with the intervention over the time horizon chosen for the analysis and enumerate the improvements in benefits from the intervention of interest. We review the basic steps used when performing economic studies based on secondary analysis of data from clinical trials using examples from myocardial infarction studies. Different types of economic analyses and the potential contributions of Markov modeling are described. Issues of measuring quality of life, patient utilities, cost of care, and potential sources of cost data are reviewed. The interpretation of incremental cost-effectiveness ratios is discussed and economic benchmarks for defining good and poor value interventions are provided.

Simpson KN; Tilley BC

2012-01-01

314

Recruitment, retention, and blinding in clinical trials.  

UK PubMed Central (United Kingdom)

The recruitment and retention of participants and the blinding of participants, health care providers, and data collectors present challenges for clinical trial investigators. This article reviews challenges and alternative strategies associated with these three important clinical trial activities. Common recruiting pitfalls, including low sample size, unfriendly study designs, suboptimal testing locations, and untimely recruitment are discussed together with strategies for overcoming these barriers. The use of active controls, technology-supported visit reminders, and up-front scheduling is recommended to prevent attrition and maximize retention of participants. Blinding is conceptualized as the process of concealing research design elements from key players in the research process. Strategies for blinding participants, health care providers, and data collectors are suggested.

Page SJ; Persch AC

2013-03-01

315

Annual technical report. PV domestic field trial  

Energy Technology Data Exchange (ETDEWEB)

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

NONE

2002-07-01

316

The National Emphysema Treatment Trial (NETT)  

Science.gov (United States)

Substantial information regarding the role of lung volume reduction surgery (LVRS) in severe emphysema emanates from the National Emphysema Treatment Trial (NETT). The NETT was not a crossover trial and therefore was able to examine the effects of optimal medical management and LVRS on short- and long-term survival, as well as lung function, exercise performance, and quality of life. The NETT generated multiple insights into the preoperative, perioperative, and postoperative management of patients undergoing thoracotomy; described pain control techniques that were safe and effective; and emphasized the need to address nonpulmonary issues to optimize surgical outcomes. After the NETT, newer investigation has focused on bronchoscopic endobronchial interventions and other techniques less invasive than LVRS to achieve lung reduction. In this review, we summarize what we currently know about the role of LVRS in the treatment of severe emphysema as a result of insights gained from the NETT and provide a brief review of the newer techniques of lung volume reduction.

Cordova, Francis; Sternberg, Alice L.; Martinez, Fernando J.

2011-01-01

317

First clinical trial with iohexol in myelography  

Energy Technology Data Exchange (ETDEWEB)

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

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

1983-01-01

318

Beta Blocker Heart Attack Trial: design features.  

UK PubMed Central (United Kingdom)

The Beta Blocker Heart Attack Trial (BHAT) is a multicenter, randomized, double-blind, placebo control clinical trial sponsored by the National Heart, Lung, and Blood Institute designed to test the effectiveness of regular propranolol administration in reducing total mortality in patients who have survived a recent acute myocardial infarction. A number of other fatal and nonfatal response variables are also being monitored. Three thousand eight hundred thirty-seven patients, ages 30-69, are being followed at 31 clinical centers for a minimum of about 2 and a maximum of 4 years after the infarction. A number of design features of BHAT are discussed. These include maintenance of patient logs, guidelines for obtaining informed consent of patients, assessment of patient knowledge about BHAT, adjustment of study drug dose based on serum levels, and comparison of 1-hr and 24-hr ambulatory electrocardiogram readings.

1981-12-01

319

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.; Halloran M. Elizabeth; Brunet Robert C.; Ribeiro José M. C.; Massad Eduardo

1994-01-01

320

Industry funded clinical trials: bias and quality.  

UK PubMed Central (United Kingdom)

The quality of the clinical data supporting the development and ultimately the approval for medical use of new drugs is often challenged. Many share the perception that the business goals of the pharmaceutical industry overrule the best scientific efforts to accrue critical knowledge on a new molecule, in order to inform investment of resources, regulatory approvals and appropriate use by patients. Despite this common belief, few scientists have attempted to assess objectively the quality of industry funded (IF) clinical trials by measuring it and comparing it with non-industry funded (NIF) clinical trials in a data-driven fashion. Overall, the average quality of IF clinical research has been reported to be higher than the quality of NIF clinical research.

Del Parigi A

2012-01-01

 
 
 
 
321

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

322

Clinical trials on systemic necrotizing vasculitides.  

UK PubMed Central (United Kingdom)

Treatments of systemic necrotizing vasculitides have progressed markedly over the past few decades. The first attempts to obtain better-adapted therapeutic strategies evaluated the indications of conventional drugs, and their abilities to prolong survival and prevent relapses, while decreasing the severity and number of side effects. Most of the prospective clinical trials were organized by the French Vasculitis Study Group and the European Vasculitis Study Group, and have contributed to optimizing targeted treatment strategies. Recent therapeutic strategies include immunomodulating methods, like plasma exchanges, or products, like intravenous immunoglobulins, or, more recently, new agents called biotherapies. Some of the latter have achieved promising effects, for example, anti-tumor necrosis factor-alpha and anti-CD20 monoclonal antibodies, and are now being evaluated in prospective trials.

Guillevin L

2010-06-01

323

Clinical trials on systemic necrotizing vasculitides.  

Science.gov (United States)

Treatments of systemic necrotizing vasculitides have progressed markedly over the past few decades. The first attempts to obtain better-adapted therapeutic strategies evaluated the indications of conventional drugs, and their abilities to prolong survival and prevent relapses, while decreasing the severity and number of side effects. Most of the prospective clinical trials were organized by the French Vasculitis Study Group and the European Vasculitis Study Group, and have contributed to optimizing targeted treatment strategies. Recent therapeutic strategies include immunomodulating methods, like plasma exchanges, or products, like intravenous immunoglobulins, or, more recently, new agents called biotherapies. Some of the latter have achieved promising effects, for example, anti-tumor necrosis factor-alpha and anti-CD20 monoclonal antibodies, and are now being evaluated in prospective trials. PMID:20206461

Guillevin, Loïc

2010-03-04

324

Endpoints for clinical trials of sarcoidosis.  

UK PubMed Central (United Kingdom)

Over the past few years an increasing number of prospective controlled sarcoidosis treatment trials have been completed. Unfortunately, these studies utilize different endpoints making comparisons between studies difficult. At the recent World Association of Sarcoidosis and other Granulomatous disease (WASOG) meeting, a session was dedicated to the evaluation of clinical endpoints for various disease manifestations. These included pulmonary, pulmonary hypertension, fatigue, cutaneous, and a classification of clinical disease phenotypes. Based on the available literature and our current understanding of the disease, recommendations for clinical evaluation were proposed for each disease category. For example, it was recommended that pulmonary studies should include changes in the forced vital capacity. Additionally, it was recommended that all trials should incorporate measurement of quality of life.

Baughman RP; Drent M; Culver DA; Grutters JC; Handa T; Humbert M; Judson MA; Lower EE; Mana J; Pereira CA; Prasse A; Sulica R; Valyere D; Vucinic V; Wells AU

2012-10-01

325

Endpoints for clinical trials of sarcoidosis.  

Science.gov (United States)

Over the past few years an increasing number of prospective controlled sarcoidosis treatment trials have been completed. Unfortunately, these studies utilize different endpoints making comparisons between studies difficult. At the recent World Association of Sarcoidosis and other Granulomatous disease (WASOG) meeting, a session was dedicated to the evaluation of clinical endpoints for various disease manifestations. These included pulmonary, pulmonary hypertension, fatigue, cutaneous, and a classification of clinical disease phenotypes. Based on the available literature and our current understanding of the disease, recommendations for clinical evaluation were proposed for each disease category. For example, it was recommended that pulmonary studies should include changes in the forced vital capacity. Additionally, it was recommended that all trials should incorporate measurement of quality of life. PMID:23461070

Baughman, R P; Drent, M; Culver, D A; Grutters, J C; Handa, T; Humbert, M; Judson, M A; Lower, E E; Mana, J; Pereira, C A; Prasse, A; Sulica, R; Valyere, D; Vucinic, V; Wells, A U

2012-10-01

326

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

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390).

Heger Ulrike; Voss Sabine; Knebel Phillip; Doerr-Harim Colette; Neudecker Jens; Schuhmacher Christoph; Faist Eugen; Diener Markus K; Kieser Meinhard; Seiler Christoph M; Büchler Markus W

2011-01-01

327

Trial surfaces, gauge fields, and planar solitons  

Energy Technology Data Exchange (ETDEWEB)

In this paper we offer one generalization of the Rajaraman trial orbit method for finding solitons in (1+1)-dimensional scalar field theory to (2+1)-dimensional models with scalar and gauge fields. By this means we find solitons in the bosonic sector of the Georgi-Glashow, Chern-Simons, and standard models, which are strings in three dimensions, suitably deformed by allowing the Goldstone bosons to become pseudo Goldstone bosons.

Fuertes, W.G. (Department of Physics, Universidad de Oviedo (Spain)); Guilarte, J.M. (Department of Physics, Universidad de Salamanca (Spain))

1994-06-15

328

Randomized clinical stroke trials in 2003.  

Science.gov (United States)

Randomized clinical stroke trials published during 2003 dealt with what impact treatment of stroke risk factors have on reducing future strokes. Treatment of hypertension and hyperlipidemia, and atrial fibrillation with a new anticoagulant, were confirmed to be beneficial. Treatment with female hormones was not beneficial. A potentially important study indicated that donepezil is a useful treatment for dementia in people who have had strokes. PMID:15191698

Rabadi, Meheroz H; Blass, John

2004-07-01

329

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.

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

2007-01-01

330

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

331

Unimed Pharmaceuticals begins HIV wasting syndrome trial.  

Science.gov (United States)

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

1996-05-01

332

Adaptive Allocation Theory in Clinical Trials  

CERN Multimedia

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 discussed.

Zhang, L X

2006-01-01

333

A randomized controlled trial of H  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ? CIN3 as the outcome. Methods/Design HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration International Standard Randomised Controlled Trial Number Register, ISRCTN79347302

Ogilvie Gina S; van Niekerk Dirk J; Krajden Mel; Martin Ruth E; Ehlen Thomas G; Ceballos Kathy; Peacock Stuart J; Smith Laurie W; Kan Lisa; Cook Darrel A; Mei Wendy; Stuart Gavin CE; Franco Eduardo L; Coldman Andrew J

2010-01-01

334

A network meta-analysis of randomized controlled trials for comparing the effectiveness and safety profile of treatments with marketing authorization for relapsing multiple sclerosis.  

UK PubMed Central (United Kingdom)

WHAT IS KNOWN AND OBJECTIVE: The relative effectiveness and safety profile of the treatments with marketing authorization for relapsing multiple sclerosis (MS) are not well known because randomized controlled trials with head-to-head comparisons between these treatments do not exist. Thus, a network of multiple-treatments meta-analysis was performed using four clinical outcomes: 'patients free of relapse', 'patients without disease progression', 'patients without MRI progression' and 'patients with adverse events'. METHODS: Randomized controlled trials (RCTs) on MS were systematically searched in PubMed and Cochrane Central Register of Controlled Trial. The network analysis performed pairwise comparisons between the marketed treatments (Betaferon 250mcg, Avonex 30mcg, Rebif 44mcg, Rebif 22mcg, Aubagio 7 mg, Aubagio 14 mg, Copaxone 20 mg, Tysabri 300 mg, Gilenya 0·5 mg and Novantrone 12 mg/m(2) ) using direct and indirect analyses. RESULTS AND DISCUSSION: The analysis included 48 articles, involving 20 455 patients with MS. The direct analysis showed better response for more than one outcome for Gilenya compared with Avonex ('patients free of relapse' and 'patients without MRI progression') and for Betaferon compared with Avonex ('patients without disease progression' and 'patients without MRI progression'). The indirect analysis indicated that Tysabri may have better relative effectiveness compared with the other treatments for two outcomes: 'patients free of relapse' and 'patients without MRI progression'. Regarding 'patients with adverse events', no data were available for all comparisons to make fair inferences. WHAT IS NEW AND CONCLUSION: This was an attempt, for the first time, to compare the efficacy and safety profile of existing approved treatments for relapsing MS. Although some treatments have shown better response, the results of the network analysis should be interpreted with caution because of the lack of RCTs with head-to-head comparisons between treatments.

Hadjigeorgiou GM; Doxani C; Miligkos M; Ziakas P; Bakalos G; Papadimitriou D; Mprotsis T; Grigoriadis N; Zintzaras E

2013-08-01

335

Clinical trial design in biosimilar drug development.  

Science.gov (United States)

In contrast to most drugs which are chemically synthesized and have a known structure, biological drugs are derived from living organisms or their products. Biologicals are structurally more complex and unique from chemically synthesized small drug molecules because of their larger size and intricate manufacturing process. Secondary to their protein structure, they are also more prone to acute and chronic immune responses. Biosimilars are intended to offer comparable safety and efficacy relative to reference brand biologicals, yet they are not generic alternatives to the original compounds and so are currently not considered interchangeable. Given their structural complexity, multifaceted manufacturing processes and risk for immunogenicity, biosimilars require class-specific regulatory approval pathways. Here we seek to provide a general overview of clinical trial design in the era of biosimilar drug development. This will include a review of the regulatory requirements for clinical trials in Europe and the United States, followed by a review of two biosimilars that have recently reported results of randomized trials against branded biologicals. PMID:23161336

Dranitsaris, G; Dorward, K; Hatzimichael, E; Amir, E

2012-11-17

336

Clinical trial design in biosimilar drug development.  

UK PubMed Central (United Kingdom)

In contrast to most drugs which are chemically synthesized and have a known structure, biological drugs are derived from living organisms or their products. Biologicals are structurally more complex and unique from chemically synthesized small drug molecules because of their larger size and intricate manufacturing process. Secondary to their protein structure, they are also more prone to acute and chronic immune responses. Biosimilars are intended to offer comparable safety and efficacy relative to reference brand biologicals, yet they are not generic alternatives to the original compounds and so are currently not considered interchangeable. Given their structural complexity, multifaceted manufacturing processes and risk for immunogenicity, biosimilars require class-specific regulatory approval pathways. Here we seek to provide a general overview of clinical trial design in the era of biosimilar drug development. This will include a review of the regulatory requirements for clinical trials in Europe and the United States, followed by a review of two biosimilars that have recently reported results of randomized trials against branded biologicals.

Dranitsaris G; Dorward K; Hatzimichael E; Amir E

2013-04-01

337

Syncrude hydraulic oil sands tailings deposition trial  

Energy Technology Data Exchange (ETDEWEB)

A full-scale hydraulic tailings deposition trial was conducted at the Syncrude Canada Ltd. oil sands mine near Fort McMurray to evaluate the technique of contained beaching as a method of tailings deposition for construction of oil sand tailings storage facilities. Contained beaching is a variation of conventional hydraulic cell construction commonly used in the oil sands industry whereby tailings are hydraulically deposited in long beaches between pre-built containment dykes. The beaching trial comprised an intensive two-week, 24-hour monitoring program of tailings deposition in a large full scale test cell (200 m wide by 1200 m long). The monitoring program was followed by a program of sampling and testing of the deposited tailings beach. The results of the monitoring program allowed an accurate mass balance of solids and water for the tailings deposition trial. A high solids capture of 93.2% of the total tailings solids in the test cell was attained. The density of the deposited beach was found to be similar to other methods of oil sand tailings beach deposition. 1 ref., 5 tabs., 5 figs.

Plewes, H.; Rice, S.; Hitchman, R. [Klohn-Crippen Consultants Ltd., Richmond, BC (Canada); List, B. [Syncrude Canada Ltd., Edmonton, AB (Canada)

1995-12-31

338

Balance algorithm for cluster randomized trials  

Directory of Open Access Journals (Sweden)

Full Text Available Abstract Background Within cluster randomized trials no algorithms exist to generate a full enumeration of a block randomization, balancing for covariates across treatment arms. Furthermore, often for practical reasons multiple blocks are required to fully randomize a study, which may not have been well balanced within blocks. Results We present a convenient and easy to use randomization tool to undertake allocation concealed block randomization. Our algorithm highlights allocations that minimize imbalance between treatment groups across multiple baseline covariates. We demonstrate the algorithm using a cluster randomized trial in primary care (the PRE-EMPT Study) and show that the software incorporates a trade off between independent random allocations that were likely to be imbalanced, and predictable deterministic approaches that would minimise imbalance. We extend the methodology of single block randomization to allocate to multiple blocks conditioning on previous allocations. Conclusion The algorithm is included as Additional file 1 and we advocate its use for robust randomization within cluster randomized trials. Additional File 1 Cluster randomization allocation algorithm version 1. Algorithms scripted in R to provide robust cluster randomization. Click here for file

Carter Ben R; Hood Kerenza

2008-01-01

339

Tirapazamine: from bench to clinical trials.  

UK PubMed Central (United Kingdom)

Tumour hypoxia continues to remain one of the greatest challenges in the treatment of solid tumours. An important avenue to follow with both radiotherapy and chemotherapy is the development of hypoxic cytotoxins such as tirapazamine. The present review covers the history of tirapazamine from preclinical models to clinical trials. The biochemistry as well as the pharmacokinetics of this bioreductive agent are presented. Laboratory data demonstrating the enhanced effect of radiation and cisplatin when combined with tirapazamine are also discussed. There is considerable evidence supporting the potentiation of anti-tumour effect of cisplatin by tirapazamine. Several clinical trials for various tumour sites have been testing the synergistic effect of cisplatin-tirapazamine with and without radiotherapy. These are also reviewed in the present paper. The current literature data on tirapazamine leaves unanswered questions about its action and toxicity. While the current number of phase III trials limits comprehensive conclusions about the administration of this drug, there is a unanimous indication that further clinical studies are warranted.

Marcu L; Olver I

2006-01-01

340

The use of minimization in clinical trials.  

Science.gov (United States)

Since its introduction in 1974 the use of the term Minimization has been broadened to include other algorithms. All algorithms use patient characteristics to determine the assignment that produces the best overall balance between treatment groups. They differ in whether or not they use all of the data from each previously assigned subject to assign subsequent subjects so the methods are classified as complete or partial minimization. PubMed, Citation Index and Cochrane searches determined the frequency of articles using these types of minimization and a subset was selected for detailed review regarding the adequacy of the usage and reporting of minimization. In the past 10 years usage has increased three fold over the previous decade but is still less than 2% of clinical trials. None of the studies makes maximum use of minimization and they are not following good reporting practices. Concerns about the use of minimization have involved selection bias and statistical analysis. Several modifications to minimization are suggested to reduce the possibility of selection bias so that adding randomization will rarely be required. Separating primary and secondary analyses can avoid the statistical problems that minimization poses. The two types of analyses are distinguished by opposite limiting signs, providing reliable, simplified statistical results. This will improve data utilization and make clinical trials more reproducible. Minimization should be the method of choice in assigning subjects in all clinical trials. PMID:20060500

Taves, Donald R

2010-01-08

 
 
 
 
341

The use of minimization in clinical trials.  

UK PubMed Central (United Kingdom)

Since its introduction in 1974 the use of the term Minimization has been broadened to include other algorithms. All algorithms use patient characteristics to determine the assignment that produces the best overall balance between treatment groups. They differ in whether or not they use all of the data from each previously assigned subject to assign subsequent subjects so the methods are classified as complete or partial minimization. PubMed, Citation Index and Cochrane searches determined the frequency of articles using these types of minimization and a subset was selected for detailed review regarding the adequacy of the usage and reporting of minimization. In the past 10 years usage has increased three fold over the previous decade but is still less than 2% of clinical trials. None of the studies makes maximum use of minimization and they are not following good reporting practices. Concerns about the use of minimization have involved selection bias and statistical analysis. Several modifications to minimization are suggested to reduce the possibility of selection bias so that adding randomization will rarely be required. Separating primary and secondary analyses can avoid the statistical problems that minimization poses. The two types of analyses are distinguished by opposite limiting signs, providing reliable, simplified statistical results. This will improve data utilization and make clinical trials more reproducible. Minimization should be the method of choice in assigning subjects in all clinical trials.

Taves DR

2010-03-01

342

Clinical trials for stem cell therapies  

Directory of Open Access Journals (Sweden)

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

Trounson Alan; Thakar Rahul G; Lomax Geoff; Gibbons Don

2011-01-01

343

Regulatory aspects of clinical trials in children.  

UK PubMed Central (United Kingdom)

Since introduction of the EU Paediatric Regulation in January 2007 the development and the life cycle of a drug in pre- and post-authorisation period has changed significantly. Pharmacovigilance science has traditionally been a discipline focussed on the post-marketing or post-authorisation period, with due attention directed towards pre-clinical safety data, clinical trials and adverse events. As the biological sciences have evolved, pharmacovigilance has slowly shifted toward earlier, proactive consideration of risks and potential benefits of drugs in the pre- and post-approval stages of drug development, leading to a maturing of drug safety risk management. The development of drugs for the paediatric population has changed the awareness that not only the safety issues need to be thoroughly investigated for a safe treatment of the children. In conjunction with the knowledge about efficacy, pharmacokinetic/pharmacodynamic and the age appropriate formulation for the concerned drug, the impact on the aim to apply safe medicines for children will steadily increase. Therefore, a proposal for a joint effort performing clinical research and appropriate drug development and clinical trials in children needs a strong support from a number of stakeholders like Clinical Trial Network, Paediatric Society, pharmaceutical industry and authorities.

Mentzer D

2009-01-01

344

Optimizing biologically targeted clinical trials for neurofibromatosis.  

UK PubMed Central (United Kingdom)

INTRODUCTION: The neurofibromatoses (neurofibromatosis type 1, NF1 and neurofibromatosis type 2, NF2) comprise the most common inherited conditions in which affected children and adults develop tumors of the central and peripheral nervous system. In this review, the authors discuss how the establishment of the Neurofibromatosis Clinical Trials Consortium (NFCTC) has positively impacted on the design and execution of treatment studies for individuals with NF1 and NF2. AREAS COVERED: Using an extensive PUBMED search in collaboration with select NFCTC members expert in distinct NF topics, the authors discuss the clinical features of NF1 and NF2, the molecular biology of the NF1 and NF2 genes, the development and application of clinically relevant Nf1 and Nf2 genetically engineered mouse models and the formation of the NFCTC to enable efficient clinical trial design and execution. EXPERT OPINION: The NFCTC has resulted in a more seamless integration of mouse preclinical and human clinical trials efforts. Leveraging emerging enabling resources, current research is focused on identifying subtypes of tumors in NF1 and NF2 to deliver the most active compounds to the patients most likely to respond to the targeted therapy.

Gutmann DH; Blakeley JO; Korf BR; Packer RJ

2013-04-01

345

The bottleneck effect in lung cancer clinical trials.  

Science.gov (United States)

Clinical trials provide the most promising way to improve treatment outcomes in cancer. This study examined the rate at which eligible patients with lung cancer, at a National Cancer Institute-designated cancer center in the South, were offered a clinical trial and explored for reasons for ineligibility. We retrospectively reviewed 300 randomly selected lung cancer patients' medical records seen in 2010, to assess clinical trial offers to eligible patients, reasons for not offering an eligible patient a trial, demographic factors associated with eligibility, and reasons for refusal among those offered a trial. Of the 300 patient charts, seven were excluded for lack of confirmed lung cancer diagnosis. Forty-six of the remaining 293 (15.7 %) patients were eligible for a clinical trial. Forty-five of the 46 (97.8 %) were considered for a trial by their oncologist. Thirty-five of the 45 (77.8 %) were offered a trial: 15 agreed (42.9 % of those offered, 5.1 % of patients reviewed), 11 declined, and 9 were undecided at the end of the review window. Patients with poor Eastern Cooperative Oncology Group (ECOG) performance status levels and small cell (SC) diagnoses were significantly less likely to be eligible for a trial. Results suggest that oncologists at the cancer center are effectively presenting all eligible patients with the option of a clinical trial; however, there is a need to increase the number of approved clinical trials for patients with SC or ECOG score greater than 2. PMID:23733149

Gonzalez, Luis E; Sutton, Steven K; Pratt, Christie; Gilbertson, Matthew; Antonia, Scott; Quinn, Gwendolyn P

2013-09-01

346

Trials needed to assess knee proprioception following stroke.  

UK PubMed Central (United Kingdom)

BACKGROUND AND PURPOSE: This study explores the number of trials required to identify clinically significant impairments in knee joint position sense and movement sense following stroke. METHOD: Proprioception was assessed in 33 stroke patients aged 37-87 years. Ten trials for each assessment were performed in sitting and supine positions using both verbal response techniques and contralateral limb matching. RESULTS: Forty-six percent of participants were identified with a proprioceptive deficit. The trial where the first incorrect response occurred varied across individuals and testing positions. Performing only one trial detected proprioceptive impairments in less than 10% patients, and incorrect responses did not always occur in the first 5 trials. In sitting, no participant failed the assessment of knee joint position sense using the verbal response technique after only 6 trials. In supine, no participant failed the assessment of knee movement sense using the verbal response technique after only 6 trials. For the assessment of knee joint position sense in sitting using contralateral limb matching an estimated 9.4% of patients with a deficit would be missed if only 3 trials were used in preference to 5. For assessment of knee joint position sense in sitting, an estimated 18.8% of patients with deficits would be missed if only 3 trials were used rather than 10 trials. CONCLUSIONS: Clinicians should perform at least 10 trials in either sitting or supine to quantify joint position sense and movement sense at the knee following stroke.

Piriyaprasarth P; Morris ME; Delany C; Winter A; Finch S

2009-03-01

347

Globalization of clinical trials - where are we heading?  

Science.gov (United States)

The last decade has witnessed a greater transparency in clinical research with the advent of clinical trial registries. The aim of the study was to describe the trends in the globalization of clinical trials in the last five years. We performed an internet search using the WHO International clinical trials registry platform (WHO ICTRP) to identify the clinical trials conducted from January 2007 to December 31, 2011 among 25 countries. Among the 25 countries, the United States, Japan and Germany occupy the top positions in the total number of clinical trials conducted. Clinical trials in the US (36312) constituted 31.5% of the total number of trials performed during this period. However over a period of five years both US and Western Europe appear to show a decline, while the emerging countries show a rise in clinical trials registered. Among the emerging countries China, India and Republic of Korea are most active regions involved in clinical trials. Cancer, diabetes and respiratory diseases were most widely researched areas overall. Although the study confirms the transition in the clinical trials research towards emerging countries, the developed regions of the world still contribute to more than 70% of the trials registered worldwide. PMID:22963351

George, Melvin; Selvarajan, Sandhiya; S, Suresh-Kumar; Dkhar, Steven A; Chandrasekaran, Adithan

2013-05-01

348

Globalization of clinical trials - where are we heading?  

UK PubMed Central (United Kingdom)

The last decade has witnessed a greater transparency in clinical research with the advent of clinical trial registries. The aim of the study was to describe the trends in the globalization of clinical trials in the last five years. We performed an internet search using the WHO International clinical trials registry platform (WHO ICTRP) to identify the clinical trials conducted from January 2007 to December 31, 2011 among 25 countries. Among the 25 countries, the United States, Japan and Germany occupy the top positions in the total number of clinical trials conducted. Clinical trials in the US (36312) constituted 31.5% of the total number of trials performed during this period. However over a period of five years both US and Western Europe appear to show a decline, while the emerging countries show a rise in clinical trials registered. Among the emerging countries China, India and Republic of Korea are most active regions involved in clinical trials. Cancer, diabetes and respiratory diseases were most widely researched areas overall. Although the study confirms the transition in the clinical trials research towards emerging countries, the developed regions of the world still contribute to more than 70% of the trials registered worldwide.

George M; Selvarajan S; S SK; Dkhar SA; Chandrasekaran A

2013-05-01

349

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

Directory of Open Access Journals (Sweden)

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

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

2006-01-01

350

Adolescent experiences in a vaccine trial: a pilot study  

Scientific Electronic Library Online (English)

Full Text Available 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 misunderstanding certain concepts regarding assent and trial processes subsequent to enrolment, participants reported positive experiences overall. Subjects' motivations for participat (more) ion 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.

Abrams, Amber; Siegfried, Nandi; Geldenhuys, Hennie

2011-12-01

351

Acute kidney injury clinical trial design: old problems, new strategies.  

UK PubMed Central (United Kingdom)

Apart from supportive dialysis there are no universally accepted interventions in acute kidney injury (AKI). We have summarized the outcomes of all published randomized, placebo-controlled studies of non-dialysis treatment of AKI. Forty-nine trials were identified, only one of which was in a paediatric population. Sixteen trials had positive outcomes; these trials are not comparable in terms of methodology used or outcomes assessed, and they share many of the problems of the negative trials. We discuss the flaws in clinical trial design that have contributed to poor or uncertain outcomes and propose minimum requirements for future trials. In particular, future trials should incorporate biomarkers specific to the etiology of the AKI, and treatment should match the phase of injury.

Endre ZH; Pickering JW

2013-02-01

352

Comparing attitudes to fish consumption between clinical trial participants and non?trial individuals  

UK PubMed Central (United Kingdom)

Aim: The study aims to investigate attitudes and perceptions influencing fish consumption in a sample of clinical trial participants and compare these perceptions to those expressed by a sample of adults not involved in the trial. Methods: Six semi?structured focus groups were conducted; three with participants of a weight loss trial which incorporated specific and general fish consumption advice (n?=?15) and three with non?trial participants from the same study population (n?=?14). All data were recorded digitally and transcribed verbatim by the moderator. Data analysis was carried out using NVivo (QSR International Pty Ltd, Melbourne, Victoria, Australia). Factors influencing fish consumption were coded into a number of sub?themes and themes. Results: The main factors that influenced fish consumption were health impact, the cost of consuming fish and seafood products, the physical and sensory characteristics of fish, food preferences of family members, and the culinary positions of fish and seafood. Conclusion: This study highlighted attitudes and perceptions that may influence fish consumption. A clinical trial incorporating dietetic intervention appeared to influence the importance participants placed on nutrition education; however, additional practical strategies may be required to address barriers to consumption such as perceived price and availability.

NEALE EP; NOLAN?CLARK D; PROBST YC; BATTERHAM MJ; TAPSELL LC

2012-06-01

353

Clinical trials in India: Where do we stand globally?  

UK PubMed Central (United Kingdom)

AIMS: To evaluate the trend of clinical trials in India over the last 4 years compared to the well-established countries using clinical trial registries since the advent of clinical trial registry of India (CTRI). MATERIALS AND METHODS: The data of clinical trials registered in India, United States (US), and European Union (EU) were obtained from websites of CTRI, clinicaltrial.gov and EU clinical trial registry, respectively from July 20, 2007 to August 29, 2011 for a period of 4 years. Trials registered in Australia, Canada, China, and Japan were obtained from WHO's international clinical trial registry platform for the same period. We used search words for the common diseases such as diabetes, hypertension, etc.. RESULTS: The total number of clinical trials registered during the study period was 67,448 across seven study nations. Clinical trials from India constituted only 2.7% of the total number of trials carried out, compared to US constituting 47% of the total number of trials registered, followed by 18% from EU and 11% from Japan. However, India, China, and Japan have been found to show an increase of 3.7%, 5.1%, and 13.1% increase in the number of trials registered in 2011 compared to 2007. In contrast, US and EU showed a decline of 11.3% and 11.95% respectively in the total number of trials registered in 2011 compared to 2007. CONCLUSIONS: Although India shows gradual increase in trials registered since the advent of CTRI, still it continues to lag behind established countries in clinical research.

Selvarajan S; George M; Kumar SS; Dkhar SA

2013-07-01

354

Pancreatic cancer clinical trials and accrual in the United States.  

UK PubMed Central (United Kingdom)

PURPOSE: Pancreatic cancer clinical trials open in the United States and their accrual were examined to identify opportunities to accelerate progress in the treatment of pancreatic cancer. METHODS: Pancreatic cancer-specific clinical trials open in the United States in the years 2011 and 2012 were obtained from the Pancreatic Cancer Action Network database. Accrual information was obtained from trial sponsors. RESULTS: The portfolio of pancreatic cancer clinical trials identified by type (adenocarcinoma or neuroendocrine), phase, disease stage, and treatment approach is reported. More than half of trials for patients with pancreatic ductal adenocarcinoma applied biologic insights to new therapeutic approaches, and 38% focused on optimization of radiation or chemotherapy delivery or regimens. In 2011, pancreatic cancer trials required total enrollment of 11,786 patients. Actual accrual to 93.2% of trials was 1,804 patients, an estimated 4.57% of the patients with pancreatic cancer alive in that year. The greatest need was for patients with resectable cancer. Trials open in 2011 enrolled an average of 15% of their total target accrual. Physician recommendations greatly influenced patients' decision to enroll or not enroll onto a clinical trial. Matching to a clinical trial within a 50-mile radius and identifying trials for recurrent/refractory disease were documented as challenges for patient accrual. CONCLUSION: Overall trial enrollment indicates that pancreatic cancer trials open in 2011 would require 6.7 years on average to complete accrual. These results suggest that harmonizing patient supply and demand for clinical trials is required to accelerate progress toward improving survival in pancreatic cancer.

Hoos WA; James PM; Rahib L; Talley AW; Fleshman JM; Matrisian LM

2013-09-01

355

AcuTrials®: an online database of randomized controlled trials and systematic reviews of acupuncture  

Science.gov (United States)

Background The growing quantity of Complementary and Alternative Medicine literature requires databases enabled with increasingly powerful search capabilities. To address this need in the area of acupuncture research, a bibliographic database of randomized controlled trials (RCTs) and systematic reviews called AcuTrials® has been developed by the Oregon College of Oriental Medicine. AcuTrials® introduces a comprehensive keyword thesaurus that categorizes details of treatment protocols and research design to an extent not currently available in MEDLINE or other databases. Description AcuTrials®, which went live in January of 2010 and is updated monthly, currently contains over 1250 articles from more than 300 journals. Articles included are English language RCTs and systematic reviews that report on medical conditions in human subjects treated by needle acupuncture. Study details are indexed by 14 key domains, such as acupuncture style and needling protocol, to create an acupuncture-relevant, searchable keyword catalogue. Keywords follow the National Library of Medicine (NLM) MeSH terminology when possible, and new keywords were created in cases where no appropriate MeSH terms were available. The resulting keyword catalogue enables users to perform sensitive, targeted searches for particular aspects of acupuncture treatment and research design. Conclusions AcuTrials® provides an extensive and innovative keyword catalogue of acupuncture research, allowing users to efficiently navigate, locate and assess the evidence base in ways not currently possible with other databases. By providing a more powerful suite of search options, the AcuTrials® database has the potential to enhance the accessibility and quality of acupuncture research.

2013-01-01

356

A model-based approach to trial-by-trial p300 amplitude fluctuations.  

Science.gov (United States)

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. PMID:23404628

Kolossa, Antonio; Fingscheidt, Tim; Wessel, Karl; Kopp, Bruno

2013-02-08

357

A model-based approach to trial-by-trial p300 amplitude fluctuations.  

UK PubMed Central (United Kingdom)

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.

Kolossa A; Fingscheidt T; Wessel K; Kopp B

2012-01-01

358

Empowering natural clinical trial advocates: nurses and outreach workers.  

Science.gov (United States)

Cancer clinical trials are essential to advancing the prevention and treatment of cancer, yet adult participation rates in clinical trials remain abysmal. Despite the essential contributions of clinical trials to science and medicine, adult participation in clinical trials remains exceedingly low, with only 2%-4% of all adult patients with cancer in the U.S. participating in clinical trials. Clinical trials accrual rates in Hawai'i follow this national trend of less than 3% of eligible patients participating in trials. Recognizing the need to increase awareness about clinical trials, the National Cancer Institute's Cancer Information Service-Pacific Region, through the Hawai'i Clinical Trials Education Coalition, has employed strategic dissemination plans to train and educate key target audiences, including registered nurses, nursing students, and community outreach workers about the availability of over 90 cancer clinical trials in Hawai'i. Previous research suggests that nurses often play a vital role in increasing a patient's understanding of clinical trials and may also act as a patient advocate in regards to participation in a clinical trial. A train-the-trainer model curriculum was developed using the Clinical Trials Education Series (CTES), a collection of multi-level resources designed by the National Cancer Institute, to educate various constituents about clinical trials. The training curriculum and workshop format is adapted based on both formal and informal needs assessments conducted with audiences prior to the planned training, yet key elements remain central to the training model. In addition, an interactive, internet-based case study was developed using local place names and cultural cues to allow training participants to engage in realistic and practical methods for locating and sharing information about clinical trials with patients and the public. This training model has been implemented in a variety of settings including three statewide nursing conferences, two college campuses, and a community-based workshop. Evaluation results consistently indicate statistically significant increases in participants' knowledge and awareness related to clinical trials, and a cadre of trained clinical trials advocates is developing. Health professional advocacy towards adult participation in clinical trials is gaining momentum, with plans to expand the training model throughout the Pacific region. PMID:19772149

Mitschke, Diane B; Cassel, Kevin; Higuchi, Paula

2007-03-01

359

Empowering natural clinical trial advocates: nurses and outreach workers.  

UK PubMed Central (United Kingdom)

Cancer clinical trials are essential to advancing the prevention and treatment of cancer, yet adult participation rates in clinical trials remain abysmal. Despite the essential contributions of clinical trials to science and medicine, adult participation in clinical trials remains exceedingly low, with only 2%-4% of all adult patients with cancer in the U.S. participating in clinical trials. Clinical trials accrual rates in Hawai'i follow this national trend of less than 3% of eligible patients participating in trials. Recognizing the need to increase awareness about clinical trials, the National Cancer Institute's Cancer Information Service-Pacific Region, through the Hawai'i Clinical Trials Education Coalition, has employed strategic dissemination plans to train and educate key target audiences, including registered nurses, nursing students, and community outreach workers about the availability of over 90 cancer clinical trials in Hawai'i. Previous research suggests that nurses often play a vital role in increasing a patient's understanding of clinical trials and may also act as a patient advocate in regards to participation in a clinical trial. A train-the-trainer model curriculum was developed using the Clinical Trials Education Series (CTES), a collection of multi-level resources designed by the National Cancer Institute, to educate various constituents about clinical trials. The training curriculum and workshop format is adapted based on both formal and informal needs assessments conducted with audiences prior to the planned training, yet key elements remain central to the training model. In addition, an interactive, internet-based case study was developed using local place names and cultural cues to allow training participants to engage in realistic and practical methods for locating and sharing information about clinical trials with patients and the public. This training model has been implemented in a variety of settings including three statewide nursing conferences, two college campuses, and a community-based workshop. Evaluation results consistently indicate statistically significant increases in participants' knowledge and awareness related to clinical trials, and a cadre of trained clinical trials advocates is developing. Health professional advocacy towards adult participation in clinical trials is gaining momentum, with plans to expand the training model throughout the Pacific region.

Mitschke DB; Cassel K; Higuchi P

2007-03-01

360

Analysis of scientific truth status in controlled rehabilitation trials.  

UK PubMed Central (United Kingdom)

RATIONALE, AIMS AND OBJECTIVES: Systematic reviews, meta-analyses and clinical guidelines (reviews) are intended to inform clinical practice, and in this sense can be thought of as scientific truthmakers. High-quality controlled trials should align to this truth, and method quality markers should predict truth status. We sought to determine in what way controlled trial quality relates to scientific truth, and to determine predictive utility of trial quality and bibliographic markers. METHOD: A sample of reviews in rehabilitation medicine was examined. Two scientific truth dimensions were established based on review outcomes. Quality and bibliographic markers were extracted from associated trials for use in a regression analysis of their predictive utility for trial truth status. Probability analysis was undertaken to examine judgments of future trial truth status. RESULTS: Of the 93 trials included in contemporaneous reviews, overall, n = 45 (48%) were true. Randomization was found more in true trials than false trials in one truth dimension (P = 0.03). Intention-to-treat analysis was close to significant in one truth dimension (P = 0.058), being more commonly used in false trials. There were no other significant differences in quality or bibliographic variables between true and false trials. Regression analysis revealed no significant predictors of trial truth status. Probability analysis reported that the reasonable chance of future trials being true was between 2 and 5%, based on a uniform prior. CONCLUSIONS: The findings are at odds with what is considered gold-standard research methods, but in line with previous reports. Further work should focus on scientific dynamics within healthcare research and evidence-based practice constructs.

Kerry R; Madouasse A; Arthur A; Mumford SD

2013-08-01

 
 
 
 
361

Patient income level and cancer clinical trial participation.  

UK PubMed Central (United Kingdom)

PURPOSE: Studies have shown an association between socioeconomic status (SES) and quality of oncology care, but less is known about the impact of patient SES on clinical trial participation. PATIENTS AND METHODS: We assessed clinical trial participation patterns according to important SES (income, education) and demographic factors in a large sample of patients surveyed via an Internet-based treatment decision tool. Logistic regression, conditioning on type of cancer, was used. Attitudes toward clinical trials were assessed using prespecified items about treatment, treatment tolerability, convenience, and cost. RESULTS: From 2007 to 2011, 5,499 patients were successfully surveyed. Forty percent discussed clinical trials with their physician, 45% of discussions led to physician offers of clinical trial participation, and 51% of offers led to clinical trial participation. The overall clinical trial participation rate was 9%. In univariate models, older patients (P = .002) and patients with lower income (P = .001) and education (P = .02) were less likely to participate in clinical trials. In a multivariable model, income remained a statistically significant predictor of clinical trial participation (odds ratio, 0.73; 95% CI, 0.57 to 0.94; P = .01). Even in patients age ? 65 years, who have universal access to Medicare, lower income predicted lower trial participation. Cost concerns were much more evident among lower-income patients (P < .001). CONCLUSION: Lower-income patients were less likely to participate in clinical trials, even when considering age group. A better understanding of why income is a barrier may help identify ways to make clinical trials better available to all patients and would increase the generalizability of clinical trial results across all income levels.

Unger JM; Hershman DL; Albain KS; Moinpour CM; Petersen JA; Burg K; Crowley JJ

2013-02-01

362

Propensity score matching in randomized clinical trials.  

UK PubMed Central (United Kingdom)

Cluster randomization trials with relatively few clusters have been widely used in recent years for evaluation of health-care strategies. On average, randomized treatment assignment achieves balance in both known and unknown confounding factors between treatment groups, however, in practice investigators can only introduce a small amount of stratification and cannot balance on all the important variables simultaneously. The limitation arises especially when there are many confounding variables in small studies. Such is the case in the INSTINCT trial designed to investigate the effectiveness of an education program in enhancing the tPA use in stroke patients. In this article, we introduce a new randomization design, the balance match weighted (BMW) design, which applies the optimal matching with constraints technique to a prospective randomized design and aims to minimize the mean squared error (MSE) of the treatment effect estimator. A simulation study shows that, under various confounding scenarios, the BMW design can yield substantial reductions in the MSE for the treatment effect estimator compared to a completely randomized or matched-pair design. The BMW design is also compared with a model-based approach adjusting for the estimated propensity score and Robins-Mark-Newey E-estimation procedure in terms of efficiency and robustness of the treatment effect estimator. These investigations suggest that the BMW design is more robust and usually, although not always, more efficient than either of the approaches. The design is also seen to be robust against heterogeneous error. We illustrate these methods in proposing a design for the INSTINCT trial.

Xu Z; Kalbfleisch JD

2010-09-01

363

Propensity score matching in randomized clinical trials.  

Science.gov (United States)

Cluster randomization trials with relatively few clusters have been widely used in recent years for evaluation of health-care strategies. On average, randomized treatment assignment achieves balance in both known and unknown confounding factors between treatment groups, however, in practice investigators can only introduce a small amount of stratification and cannot balance on all the important variables simultaneously. The limitation arises especially when there are many confounding variables in small studies. Such is the case in the INSTINCT trial designed to investigate the effectiveness of an education program in enhancing the tPA use in stroke patients. In this article, we introduce a new randomization design, the balance match weighted (BMW) design, which applies the optimal matching with constraints technique to a prospective randomized design and aims to minimize the mean squared error (MSE) of the treatment effect estimator. A simulation study shows that, under various confounding scenarios, the BMW design can yield substantial reductions in the MSE for the treatment effect estimator compared to a completely randomized or matched-pair design. The BMW design is also compared with a model-based approach adjusting for the estimated propensity score and Robins-Mark-Newey E-estimation procedure in terms of efficiency and robustness of the treatment effect estimator. These investigations suggest that the BMW design is more robust and usually, although not always, more efficient than either of the approaches. The design is also seen to be robust against heterogeneous error. We illustrate these methods in proposing a design for the INSTINCT trial. PMID:19995353

Xu, Zhenzhen; Kalbfleisch, John D

2010-09-01

364

Randomized clinical stroke trials in 2004.  

Science.gov (United States)

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

Rabadi, Meheroz H; Blass, John

2005-07-01

365

Clinical trials in orthodontics I: demographic details of clinical trials published in three orthodontic journals between 1989 and 1998.  

UK PubMed Central (United Kingdom)

Aim: To test the hypothesis that there is insufficient evidence available, from clinical trials, to allow evidence-based decisions to be made on the effectiveness of orthodontic treatment. OBJECTIVES: To identify reports of orthodontic clinical trials and assess their demographic characteristics. DESIGN: A retrospective, observational study. SETTING: The American Journal of Orthodontics and Dentofacial Orthopedics, British Journal of Orthodontics, and European Journal Orthodontics. DATA SOURCE: Clinical trials published between 1989 and 1998. METHOD: A hand-search was performed to identify all clinical trials. The journal and year of publication, research method, interventions, and sample size of the trials reported were recorded. RESULTS: One-hundred-and-fifty-five trial reports were identified of which 56 (36.1%) were published from 1989 to 1993 and 99 (69%) from 1994 to 1998. Ninety-nine (69%) reports were published in the AJO-DO, 18 (11.6%) in the BJO and 38 (24.5%) in the EJO. Eighty-five (54.8%) were reports of randomized controlled trials and 70 (45.2%) of controlled clinical trials. The interventions most frequently assessed were bonding materials (21.9%), growth modification treatments (21.3%), and oral hygiene procedures (9.0%). The median sample size was 32 (IQR 19.5, 50). CONCLUSION: There is sufficient evidence available from clinical trials to warrant doing systematic reviews of orthodontic clinical trials to aid decision-making.

Harrison JE

2003-03-01

366

Good clinical practice: International quality standard for clinical trials  

Directory of Open Access Journals (Sweden)

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

Radulovi? Siniša S.

2003-01-01

367

Advancing the educational and career pathway for clinical trials nurses.  

UK PubMed Central (United Kingdom)

Clinical trials nurses play a pivotal role in the conduct of clinical research, but the educational and career pathway for these nurses remains unclear. This article reports findings from a survey of nurses working in cancer clinical trials research in Australia. Most participants held postgraduate qualifications (42 of 61); however, clinical trials education was primarily attained through short professional development courses. Interest in pursuing trial-specific postgraduate education was high, but barriers were identified, including cost, time, and unclear benefit for career advancement. Job titles varied substantially, which is indicative of an unclear employment pathway. These findings suggest that initiatives to improve the educational and career pathway for clinical trials nurses are needed and should include the following: formal educational preparation, greater consistency in employment status, and clearer career progression. These strategies should be underpinned by broad professional recognition of the clinical trials nurse as a specialized nursing role.

Scott K; White K; Roydhouse JK

2013-04-01

368

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

UK PubMed Central (United Kingdom)

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

Kim YD; Heo I; Shin BC; Crawford C; Kang HW; Lim JH

2013-01-01

369

Grassroots campaign trail methods to recruit for clinical trials: recruitment lessons learned from trail to trial.  

UK PubMed Central (United Kingdom)

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

Murphy M; Merenstein D

2011-01-01

370

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

UK PubMed Central (United Kingdom)

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

Palevsky PM; Molitoris BA; Okusa MD; Levin A; Waikar SS; Wald R; Chertow GM; Murray PT; Parikh CR; Shaw AD; Go AS; Faubel SG; Kellum JA; Chinchilli VM; Liu KD; Cheung AK; Weisbord SD; Chawla LS; Kaufman JS; Devarajan P; Toto RM; Hsu CY; Greene T; Mehta RL; Stokes JB; Thompson AM; Thompson BT; Westenfelder CS; Tumlin JA; Warnock DG; Shah SV; Xie Y; Duggan EG; Kimmel PL; Star RA

2012-05-01

371

Impact of length or relevance of questionnaires on attrition in online trials: randomized controlled trial.  

Digital Repository Infrastructure Vision for European Research (DRIVER)

There has been limited study of factors influencing response rates and attrition in online research. Online experiments were nested within the pilot (study 1, n = 3780) and main trial (study 2, n = 2667) phases of an evaluation of a Web-based intervention for hazardous drinkers: the Down Your Drink ...

McCambridge, J; Kalaitzaki, E; White, IR; Khadjesari, Z; Murray, E; Linke, S; Thompson, SG; Godfrey, C; Wallace, P

372

Challenges of randomized controlled trial design in plastic surgery  

Science.gov (United States)

Randomized controlled trials are the gold standard of evidence-based medicine. In the field of plastic surgery, designing these studies is much more challenging than in pharmaceutical medicine. Randomized trials in plastic surgery encompass several road blocks including problems shared with other surgical trials: equipoise, high cost, placebo issues and learning curves following the establishment of a novel approach. In addition, plastic surgery has more subjective outcomes, thus making study design even more difficult in assessing the end result.

Hassanein, Aladdin H; Herrera, Fernando A; Hassanein, Omar

2011-01-01

373

Shining light on vitamin D trials in chronic kidney disease.  

Science.gov (United States)

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

Nigwekar, Sagar U; Thadhani, Ravi I

2013-02-01

374

[Clinical trial updates for malignant brain tumors].  

Science.gov (United States)

Gliomas account for approximately 40% of all brain tumors and are thus the most common primary tumors of the central nervous system (CNS). High-grade (WHO grades III and IV) malignant gliomas that include anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic oligoastrocytoma (AOA), and glioblastoma multiforme (GBM) are often resistant to treatment; especially, GBM, the most common glioma in adults, kills patients within a median time span of a year after diagnosis despite treatment with aggressive surgical resection, chemotherapy, and radiotherapy. In 2006, Temozolomide (TMZ) was certified as the treatment agent for malignant gliomas in Japan, and it is now used as the first-line therapy. However, its clinical outcomes depend on the O(6)-methylguanine-DNA methyltransferase (MGMT) status, and MGMT modification is one of the key factors to obtain greater clinical benefits. Previously, we demonstrated that Interferon-? (IFN-?) markedly enhanced chemosensitivity to TMZ in an in vitro study of human glioma cells; this finding suggested that one of the major mechanisms by which IFN-? enhances chemosensitivity is the downregulation of MGMT transcription via p53 induction. Previously, we tried clinical trial of gene therapy by means of IFN-? gene in order to evaluate the safety, feasibility, and preliminary clinical effectiveness, and reasonable results could be obtained. As a next step, we are conducting a clinical trial study, namely, genomic therapy using with siRNA-MGMT. We hope that these new regimen will be safe and well tolerated, and may prolong survival in patients with GBM. PMID:22277391

Wakabayashi, Toshihiko

2011-11-01

375

[Clinical trial updates for malignant brain tumors].  

UK PubMed Central (United Kingdom)

Gliomas account for approximately 40% of all brain tumors and are thus the most common primary tumors of the central nervous system (CNS). High-grade (WHO grades III and IV) malignant gliomas that include anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic oligoastrocytoma (AOA), and glioblastoma multiforme (GBM) are often resistant to treatment; especially, GBM, the most common glioma in adults, kills patients within a median time span of a year after diagnosis despite treatment with aggressive surgical resection, chemotherapy, and radiotherapy. In 2006, Temozolomide (TMZ) was certified as the treatment agent for malignant gliomas in Japan, and it is now used as the first-line therapy. However, its clinical outcomes depend on the O(6)-methylguanine-DNA methyltransferase (MGMT) status, and MGMT modification is one of the key factors to obtain greater clinical benefits. Previously, we demonstrated that Interferon-? (IFN-?) markedly enhanced chemosensitivity to TMZ in an in vitro study of human glioma cells; this finding suggested that one of the major mechanisms by which IFN-? enhances chemosensitivity is the downregulation of MGMT transcription via p53 induction. Previously, we tried clinical trial of gene therapy by means of IFN-? gene in order to evaluate the safety, feasibility, and preliminary clinical effectiveness, and reasonable results could be obtained. As a next step, we are conducting a clinical trial study, namely, genomic therapy using with siRNA-MGMT. We hope that these new regimen will be safe and well tolerated, and may prolong survival in patients with GBM.

Wakabayashi T

2011-11-01

376

Prevention and intervention trials for colorectal cancer.  

Science.gov (United States)

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

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

2013-04-23

377

Randomized clinical stroke trials in 2007.  

Science.gov (United States)

This article reviews the randomized control trials (RCT's) that were published in 2007 of emerging pharmacotherapies in patients with acute (/= 12 weeks) stroke. A Medline search generated 22 RCT's in stroke in the year 2007 in the English language. These trials were primarily efficacy studies. These included the role of statins (an anti-lipid agent) in reducing post-stroke morbidity and mortality, and decreasing the carotid atherosclerotic plaque in middle aged patients at increased risk of cardiovascular disease; glucose-potassium-insulin infusion in hyperglyceamic acute stroke patients; pioglitazone (an anti-diabetic medication) to reduce recurrence of stroke in Type 2 diabetic patients; administration of intra-arterial urokinase (a thrombolytic agent) and the role of laser therapy in clot dissolution given that at present there is only one FDA approved thrombolytic agent (r TPA); benefit of warfarin (an anticoagulant) in elderly patients with atrial fibrillation in the community; NXY (a free radical trapping agent) and minocycline both tested as neuroprotectants; and zoledronate (an intravenous bisphosphonate) to prevent loss of bone mineral density of the affected extremity, and finally the role of nicardipine (a Calcium channel blocker) in the prevention of vasospasm, and hydrocortisone to prevent hyponatraemia after sub-arachnoid hemorrhage. Finally the role of non-pharmacotherapy like stents for patient's with internal carotid artery dissection with tandem internal carotid and middle cerebral artery occlusion and in vertebral artery stenosis. PMID:19452012

Rabadi, Meheroz H; Blass, John P

2008-10-31

378

Competency to stand trial among female inpatients.  

UK PubMed Central (United Kingdom)

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

Kois L; Pearson J; Chauhan P; Goni M; Saraydarian L

2013-08-01

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

2011-01-01

380

Clinical trial of BNCT for glioblastoma multiforme  

Energy Technology Data Exchange (ETDEWEB)

Boron neutron capture therapy (BNCT) is a binary treatment modality that can selectively irradiate tumor tissue. BNCT uses drugs containing a stable isotope of boron, {sup 10}B, to sensitize tumor cells to irradiation by low-energy (thermal) neutrons. The interaction of the {sup 10}B with a thermal neutron (neutron capture) causes the {sup 10}B nucleus to split, releasing an alpha particle and a lithium nucleus. These products of the {sup 10}B(n,a){sup 7}Li reaction are very damaging to cells but have a combined path length in tissue of {approx}14{mu}m, or roughly the diameter of one or two cells. Thus, most of the ionizing energy imparted to tissue is localized to {sup 10}B-loaded cells, and it is the distribution pattern of the boron compound that is the key to the effectiveness of BNCT. Based on extensive preclinical studies, a phase I/II clinical trial of BNCT for patients with a highly malignant type of brain tumor, glioblastoma multiforme (GBM), was initiated using the epithermal neutron beam of the Brookhaven Medical Research Reactor. The objectives of the phase I/II clinical trial are: 1. to determine the safety of a series of escalating BNCT doses using a boronated amino acid (BPA) and epithermal neutrons; 2. to evaluate any ad