Hut clusters on Ge(001) surfaces studied by STM and synchrotron X-ray diffraction

DEFF Research Database (Denmark)

Nielsen, M.; Smilgies, D.-M.; Feidenhans'l, R.

1996-01-01

Nanoscale hut clusters formed on Ge(001) surfaces by depositing one monolayer of indium and annealing at temperatures between 350 and 500 degrees C were studied by scanning tunnelling microscopy and synchrotron X-ray diffraction. It was found that the hut clusters form regular arrays over...

Profile of pregnant women using delivery hut services of the Ballabgarh Health and Demographic Surveillance System in rural north India.

Science.gov (United States)

Kant, Shashi; Haldar, Partha; Singh, Arvind K; Archana, S; Misra, Puneet; Rai, Sanjay

2016-08-01

To describe women who attended two delivery huts in rural Haryana, India. The present observational study assessed routinely collected service provision data from two delivery huts located at primary health centers in the district of Faridabad. Data on sociodemographic characteristics, prenatal care, use of free transport services, and maternal and neonatal indicators at delivery were assessed for all pregnant women who used the delivery hut services from January 2012 to June 2014. During the study period, 1796 deliveries occurred at the delivery huts. The mean age of the mothers was 23.3 ± 3.3 years (95% confidence interval 23.1-23.5). Of 1648 mothers for whom data were available, 1039 (63.0%) had travelled less than 5 km to the delivery hut. The proportion of mothers who belonged to a lower caste increased from 31.0% (193/622) in 2012 to 41.1% (162/394) in 2014. The proportion of mothers who were illiterate also increased, from 8.1% (53/651) in 2012 to 26.4% (104/394) in 2014. Belonging to a disadvantaged social group (in terms of caste or education) was not an obstacle to use of delivery hut services. The delivery huts might have satisfied some unmet needs of community members in rural India. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

The effect of farrowing environment and previous experience on the maternal behaviour of sows in indoor pens and outdoor huts.

Science.gov (United States)

Wülbers-Mindermann, M; Berg, C; Illmann, G; Baulain, U; Algers, B

2015-04-01

Outdoor farrowing huts facilitate a less restricted maternal behaviour in sows compared with sows kept indoors in farrowing pens. The aim of our study was to investigate whether there are behavioural differences between primiparous sows kept outdoors in farrowing huts and indoors in pens, and whether the maternal behaviour during the second parity, when all sows were kept outdoors in farrowing huts, would differ between sows that have experienced the indoor or the outdoor environment, respectively, during their first parturition. A total of 26 Yorkshire×Swedish Landrace sows were studied. Of these, 11 sows were housed outdoors in farrowing huts during both parturitions (group=OUTOUT). The other 15 sows were kept indoors in a barn with single farrowing pens during their first parturition. During their second parturition, sows were kept outdoors in farrowing huts (group=INOUT). The behaviour was video recorded from 2 h prepartum to 48 h postpartum. The sows' responsiveness to playbacks of a piglet's screams was tested on days 2 to 3 postpartum. Parity 1: during the last 2 h prepartum, OUTOUT sows had a higher proportion of observations in the sternal lying position (Pbehavioural differences between INOUT and OUTOUT sows. In conclusion, it is not problematic for a second parity sow with initial maternal experience from an indoor farrowing pen to be kept outdoors in farrowing huts during its following farrowing.

Luminescence dating of anthropogenic features of the San Luis Valley, Colorado: from stone huts to stone walls

Science.gov (United States)

Mahan, Shannon; Donlan, Rebecca A.; Kardos, Barbara Maat

2015-01-01

The Snake Nest Wall site and the Crestone Stone Huts are in the northern San Luis Valley, Colorado, and provide a unique opportunity to date high-altitude archeological sites of unknown age and origin using optically stimulated luminescence (OSL). We sampled sediment underlying foundation stones of these structures to establish a chronological framework for each site's construction. OSL dating of the quartz grains directly under the Snake Nest Wall suggest that the stones and, therefore, the structure was most recently emplaced between 1855 and 1890 A.D. Dating of the sediment beneath the Crestone Stone Huts suggests the construction time of these huts is between 1860 and 1890 A.D. Analysis of the equivalent dose (DE) dispersion of the OSL samples at Snake Nest Wall and the Crestone Huts shows that the majority of sediments were fully bleached prior to deposition and the low scatter suggests that short-term or shallow alluvial processes were the dominant transport for sediments. In both cases, the OSL ages show that the construction was during very recent historical times, although it is likely that the Snake Nest Wall was rebuilt in the late 19th century. Further study is warranted at the Snake Nest Wall since it shows signs of greater antiquity and a continued presence of human use. The Crestone Huts are shown to be a product of railroad building during the boomtown days of Lucky and Crestone.

Experimental hut evaluation of bednets treated with an organophosphate (chlorpyrifos-methyl or a pyrethroid (lambdacyhalothrin alone and in combination against insecticide-resistant Anopheles gambiae and Culex quinquefasciatus mosquitoes

Directory of Open Access Journals (Sweden)

Corbel Vincent

2005-05-01

Full Text Available Abstract Background Pyrethroid resistant mosquitoes are becoming increasingly common in parts of Africa. It is important to identify alternative insecticides which, if necessary, could be used to replace or supplement the pyrethroids for use on treated nets. Certain compounds of an earlier generation of insecticides, the organophosphates may have potential as net treatments. Methods Comparative studies of chlorpyrifos-methyl (CM, an organophosphate with low mammalian toxicity, and lambdacyhalothrin (L, a pyrethroid, were conducted in experimental huts in Côte d'Ivoire, West Africa. Anopheles gambiae and Culex quinquefasciatus mosquitoes from the area are resistant to pyrethroids and organophosphates (kdr and insensitive acetylcholinesterase Ace.1R. Several treatments and application rates on intact or holed nets were evaluated, including single treatments, mixtures, and differential wall/ceiling treatments. Results and Conclusion All of the treatments were effective in reducing blood feeding from sleepers under the nets and in killing both species of mosquito, despite the presence of the kdr and Ace.1R genes at high frequency. In most cases, the effects of the various treatments did not differ significantly. Five washes of the nets in soap solution did not reduce the impact of the insecticides on A. gambiae mortality, but did lead to an increase in blood feeding. The three combinations performed no differently from the single insecticide treatments, but the low dose mixture performed encouragingly well indicating that such combinations might be used for controlling insecticide resistant mosquitoes. Mortality of mosquitoes that carried both Ace.1R and Ace.1S genes did not differ significantly from mosquitoes that carried only Ace.1S genes on any of the treated nets, indicating that the Ace.1R allele does not confer effective resistance to chlorpyrifos-methyl under the realistic conditions of an experimental hut.

Towards the ecotourism: a decision support model for the assessment of sustainability of mountain huts in the Alps.

Science.gov (United States)

Stubelj Ars, Mojca; Bohanec, Marko

2010-12-01

This paper studies mountain hut infrastructure in the Alps as an important element of ecotourism in the Alpine region. To improve the decision-making process regarding the implementation of future infrastructure and improvement of existing infrastructure in the vulnerable natural environment of mountain ecosystems, a new decision support model has been developed. The methodology is based on qualitative multi-attribute modelling supported by the DEXi software. The integrated rule-based model is hierarchical and consists of two submodels that cover the infrastructure of the mountain huts and that of the huts' surroundings. The final goal for the designed tool is to help minimize the ecological footprint of tourists in environmentally sensitive and undeveloped mountain areas and contribute to mountain ecotourism. The model has been tested in the case study of four mountain huts in Triglav National Park in Slovenia. Study findings provide a new empirical approach to evaluating existing mountain infrastructure and predicting improvements for the future. The assessment results are of particular interest for decision makers in protected areas, such as Alpine national parks managers and administrators. In a way, this model proposes an approach to the management assessment of mountain huts with the main aim of increasing the quality of life of mountain environment visitors as well as the satisfaction of tourists who may eventually become ecotourists. Copyright © 2010 Elsevier Ltd. All rights reserved.

The destabilization of the Pilatte hut (2577 m a.s.l. - Ecrins massif, France), a paraglacial process?

Science.gov (United States)

Ravanel, Ludovic; Dubois, Laurent; Fabre, Sébastien; Duvillard, Pierre-Allain; Deline, Philip

2015-04-01

The Pilatte hut is located at 2572 m a.s.l. at Saint-Christophe-en-Oisans (south of the Ecrins Massif, France), at a 3-hours-walk from La Bérarde hamlet. Its capacity is 120 beds for hikers and climbers who are engaged in the ascent of Les Bans (3669 m a.s.l.). Built on a rocky ledge on the right side of the Pilatte Glacier (A = 2.64 km2; L = 2.6 km), it currently dominates the glacier by about 150 m. This relief results from the retreat of the glacier since the end of the Little Ice Age, as the till around the hut was deposited during this stage. The glacier has lost about 1.8 km in length during the same period. A first wooden hut was built in 1925 and presently serves as a winter refuge. In 1954, the growth of mountain activities led to the construction of a larger hut made of cemented stones. An extension to the west made of reinforced concrete was built in 1994. But in the late 1980s, severe damages to the 1954 part of the building were already recognized: vertical cracks lining the north and south facades, ,subsidence (c. 10 cm downstream) of the ground floor, cracked interior walls. Currently, the evolution of the instability is monitored by several methods: - since 2003, cracks in the building are surveyed by 25 Saugnac gauges, while an outside fracture in the rock is surveyed by a simple extensometer; - since 2009, 8 strain gauges allow to annually measure displacements along the main fractures that delimit the unstable rock mass; - a high-resolution topographic data set acquired by terrestrial laser scanning from the surface of the glacier in July 2014 has completed the monitoring. The acting process is a translational slide of a rock mass with a volume of about 300 000 m3, initiated by the glacier shrinkage. Therefore, it has to be considered as a paraglacial process. Even if the slide velocity is presently decreasing, a demolition project of the hut is under consideration in favor of a new building on the right side of the valley, 800 m downstream the

Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial

OpenAIRE

Ayisha Diop, MPH; Bocar Daff, MD; Maimouna Sow, MA; Jennifer Blum, MPH; Mamadou Diagne, PhD; Nancy L Sloan, DrPH; Beverly Winikoff, MD

2016-01-01

Background: Access to injectable uterotonics for management of postpartum haemorrhage remains limited in Senegal outside health facilities, and misoprostol and oxytocin delivered via Uniject have been deemed viable alternatives in community settings. We aimed to compare the efficacy of these drugs when delivered by auxiliary midwives at maternity huts. Methods: We did an unmasked cluster-randomised controlled trial at maternity huts in three districts in Senegal. Maternity huts with auxili...

Comparison of experimental hut entrance and exit behavior between Anopheles darlingi from the Cayo District, Belize, and Zungarococha, Peru.

Science.gov (United States)

Sachs, Paige; Diaz Rodriguez, Gloria Alicia; Briceno, Ireneo; King, Russell; Achee, Nicole L; Grieco, John P

2013-12-01

Anopheles darlingi is a major vector for malaria in Central and South America. Behavioral, ecological, genetic, and morphologic variability has been observed across its wide distribution. Recent studies have documented that 2 distinct genotypes exist for An. darlingi: a northern lineage (Belize, Guatemala, Colombia, Venezuela, and Panama) and a southern lineage (Amazonia and southern Brazil). In order to determine if these genotypes exhibited different behavioral traits, entrance and exit movement patterns between 2 field populations of An. darlingi that represented each genotype were evaluated using experimental huts. The Belize population exhibited bimodal entrance, with peak entry occurring between 7:00-8:00 p.m. and 5:00-6:00 a.m. and peak exiting occurring between 7:00-8:00 p.m. The Peru population exhibited unimodal entrance, with peak entry occurring between 10:00-11:00 p.m. and peak exiting occurring between 11:00-12:00 a.m. with a secondary smaller peak at 2:30 a.m. Entrance and exit behavioral patterns were significantly different between the Belize and Peru populations of An. darlingi (log-rank [Mantel-Cox] P < 0.001). Information from the present study will be used in the future to determine if there is a correlation between genotype and host-seeking behavior and can be used in the present for regional vector risk assessment.

Ultrastructural modification of the plasma membrane in HUT 102 lymphoblasts by long-wave ultraviolet light, psoralen, and PUVA

International Nuclear Information System (INIS)

Malinin, G.I.; Lo, H.K.; Hornicek, F.J.; Malinin, T.I.

1990-01-01

Ultrastructural alterations of the plasma membrane in HUT 102 lymphoblasts were assessed after a 2-h interaction with a suprapharmacologic (15 micrograms/ml) concentration of 8-MOP, 2-h irradiation with UVA (2.1 mW/cm2), and the exposure of the HUT 102 cells to PUVA under the same conditions. The dark reaction of HUT cells with 8-MOP resulted in the disappearance of microvilli, the emergence of plasma-membrane-associated spherical bodies, formation of lamellar fungiform membrane evaginations, and, in approximately 1% of the cells, formation of uropods and cell capping. Except for uropod formation and cell capping, UVA has induced the same plasma-membrane alterations, and was more deleterious to structural cytoplasmic integrity than 8-MOP. Morphologic changes of the plasma membrane in PUVA-exposed cells tended to replicate structural alterations elicited independently during the dark reaction by suprapharmacologic 8-MOP concentrations. Partial retention of microvilli by cells after PUVA was the sole exception. In light of all available evidence we conclude that psoralen during the dark reactions interacts with plasma membrane lipids by as yet undisclosed mechanisms and that in addition to lipids, membrane proteins are also the primary target of the initial interaction of HUT 102 cells with psoralen during PUVA treatment

Pizza Hut, Domino's, and the Public Schools: Making Sense of Commercialization.

Science.gov (United States)

Stark, Andrew

2001-01-01

Describes different types of partnerships between schools and businesses, discussing the benefits of and drawbacks to the commercial aspects of programs like Pizza Hut's, in which children who read a certain number of books receive free pizza, and programs like Dominos', in which schools receive materials or money in return for students buying…

`Mountain Hut` promotion programme of Isar Amperwerke - interim project report; Foerderprogramm Berghuetten der Isar-Amperwerke - Projektstatus

Energy Technology Data Exchange (ETDEWEB)

Pfeiffer, G.; Reiner, H. [Isar-Amperwerke AG, Abt. ETK, Muenchen (Germany)

1997-12-31

The purpose of the ``Mountain Hut`` promotion programme is to accelerate the conversion of mountain hut power supply systems to renewables. Under this programme, which exclusively promotes the installation of renewable energy systems (hydropower, solar energy, wind power, biomass), Isar Amperwerke contributes up to a maximum of 50% of the investment costs. The present article briefly reports on four projects that have already been realised. (HW) [Deutsch] Mit dem Foerderprogramm `Berghuetten` soll die Stromversorgung von Berghuetten staerker auf erneuerbare Energietraeger umgestellt werden. Die Zuschussrate der Isar-Amper-Werke betraegt dabei maximal 50%, wobei nur regenerative Energien (Wasserkraft, Solarenergie, Windkraft und Biomasse) gefoerdert werden. Der vorliegende Beitrag gibt einen Ueberblick ueber vier schon realisierte Projekte. (HW)

Growth and decay of hcp-like Cu hut-shaped structures on W(100)

NARCIS (Netherlands)

Bollmann, Tjeerd Rogier Johannes; van Gastel, Raoul; Wormeester, Herbert; Zandvliet, Henricus J.W.; Poelsema, Bene

2012-01-01

We have studied both the morphology and structure of thin Cu deposits on W(100) during growth and desorption, using low-energy electron microscopy (LEEM) and selective area low-energy electron diffraction (μLEED). During growth at 674 K hut-shaped Cu crystallites with steep facets (> 54∘) coexist

Multiangular L-band Datasets for Soil Moisture and Sea Surface Salinity Retrieval Measured by Airborne HUT-2D Synthetic Aperture Radiometer

Science.gov (United States)

Kainulainen, J.; Rautiainen, K.; Seppänen, J.; Hallikainen, M.

2009-04-01

SMOS is the European Space Agency's next Earth Explorer satellite due for launch in 2009. It aims for global monitoring of soil moisture and ocean salinity utilizing a new technology concept for remote sensing: two-dimensional aperture synthesis radiometry. The payload of SMOS is Microwave Imaging Radiometer by Aperture Synthesis, or MIRAS. It is a passive instrument that uses 72 individual L-band receivers for measuring the brightness temperature of the Earth. From each acquisition, i.e. integration time or snapshot, MIRAS provides two-dimensional brightness temperature of the scene in the instrument's field of view. Thus, consecutive snapshots provide multiangular measurements of the target once the instrument passes over it. Depending on the position of the target in instrument's swath, the brightness temperature of the target at incidence angles from zero up to 50 degrees can be measured with one overpass. To support the development MIRAS instrument, its calibration, and soil moisture and sea surface salinity retrieval algorithm development, Helsinki University of Technology (TKK) has designed, manufactured and tested a radiometer which operates at L-band and utilizes the same two-dimensional methodology of interferometery and aperture synthesis as MIRAS does. This airborne instrument, called HUT-2D, was designed to be used on board the University's research aircraft. It provides multiangular measurements of the target in its field of view, which spans up to 30 degrees off the boresight of the instrument, which is pointed to the nadir. The number of independent measurements of each target point depends on the flight speed and altitude. In addition to the Spanish Airborne MIRAS demonstrator (AMIRAS), HUT-2D is the only European airborne synthetic aperture radiometer. This paper presents the datasets and measurement campaigns, which have been carried out using the HUT-2D radiometer and are available for the scientific community. In April 2007 HUT-2D participated

Yaşar Şâdi Efendi’nin “Hutût-ı Meşâhir” İsimli Hatıra Defteri ve Muhtevası

OpenAIRE

BERK, Süleyman

2015-01-01

The periodicals of “Hutût-ı Meşâhir” can be considered as a type of journal. (Hutût-i meşâhir: The writings of celebrities) Many different people may be offered to write on these journals with their handwriting and they are expected to express themselves via anything like poems, aphorism or any other artistic skills spontaneously. The most comprehensive journal among the reprints of “Hutût-ı Meşâhir” that are discovered up to now, is the one that belongs to Yaşar Sadi. In the period coveri...

Durability study on material of wooden panel elements used for the old living hut built in 1969 at Syowa Station, Antarctica

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Toshimasa Konishi

2002-09-01

Full Text Available The purpose of this study is to determine the durability of the old living hut built in 1969 at Syowa Station, Japan's permanent Antarctic observation facility, especially of its wooden panels. The hut, of high floor type wooden panel construction, was built in January 1969. To determine the durability, part of the hut, which was brought back to Japan after 30 years, was rebuilt, then taken apart again under controlled test conditions. Tests included visual observation, testing of the wooden material, and testing of the performance of the thermal insulation material. The results showed that the material in the roof panels deteriorated considerably more than that in the walls and floors. In the severe polar conditions, the strength of the overall structure depends heavily on the joints between panels. It is clear that material on the indoor sides, and in the interiors of the panels, hardly deteriorated at all after 30 years.

Evolution of hut access facing glacier shrinkage in the Mer de Glace basin (Mont Blanc massif, France)

Science.gov (United States)

Mourey, Jacques; Ravanel, Ludovic

2016-04-01

Given the evolution of high mountain environment due to global warming, mountaineering routes and huts accesses are more and more strongly affected by glacial shrinkage and concomitant gravity processes, but almost no studies have been conducted on this relationship. The aim of this research is to describe and explain the evolution over the last century of the access to the five alpine huts around the Mer de Glace glacier (Mont Blanc massif), the larger French glacier (length = 11.5 km, area = 30 km²), a major place for Alpine tourism since 1741 and the birthplace of mountaineering, by using several methods (comparing photographs, surveying, collecting historical documents). While most of the 20th century shows no marked changes, loss of ice thickness and associated erosion of lateral moraines generate numerous and significant changes since the 1990s. Boulder falls, rockfalls and landslides are the main geomorphological processes that affect the access, while the glacier surface lowering makes access much longer and more unstable. The danger is then greatly increased and the access must be relocated and/or equipped more and more frequently (e.g. a total of 520 m of ladders has been added). This questions the future accessibility to the huts, jeopardizing an important part of mountaineering and its linked economy in the Mer de Glace area.

'Like Playing with Fire Under a Hut' - You Will Get Burnt If You Do ...

African Journals Online (AJOL)

'Like Playing with Fire Under a Hut' - You Will Get Burnt If You Do Not Adjust: Reflections of Social Work Students on Adjusting to University Life. ... High dropout rates in first year and the enculturation into the academic literacies essential in promoting a successful academic adjustment are some of the challenges faced by ...

Comparison of a fission-gas effects in a transient overpower test (HUT 5-7A) to FRAS3 code predictions

International Nuclear Information System (INIS)

Gruber, E.E.; Randklev, E.H.

1979-01-01

Fission gas has an important bearing on fuel dynamics during reactor transients. Fission-gas bubble sizes and densities, both within grains and on grain boundaries, are characterized as functions of radial location at the axial midplane in studies of PNL-9 fuel microstructures before and after the HUT 5-7A (PNL 9-25) TREAT test. The FRAS3 code, being developed to model fission-gas effects in reactor transients, is applied to analyze the results of the HUT 5-7A test are presented to illustrate the observed phenomena and the validity of the modeling approach

Insecticidal and sterilizing effect of Olyset Duo®, a permethrin and pyriproxyfen mixture net against pyrethroid-susceptible and -resistant strains of Anopheles gambiae s.s.: a release-recapture assay in experimental huts

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Djènontin Armel

2015-01-01

Full Text Available In the context of the widespread distribution of pyrethroid resistance among malaria vectors, we did a release-recapture trial in experimental huts to investigate the insecticidal and sterilizing effects of a novel long-lasting net (LN, Olyset® Duo, incorporating a mixture of permethrin (PER and the insect growth regulator (IGR, pyri-proxyfen (PPF. An LN containing PPF alone and a classic Olyset® Net were tested in parallel as positive controls. The effect of progressive number of holes (6, 30, or 150 that may accrue in nets over time was simulated. We used two laboratory Anopheles gambiae s.s. strains: the susceptible Kisumu strain and the pyrethroid-resistant VK-Per strain having solely kdr as resistance mechanism. The effect of these nets on the reproductive success of blood-fed females that survived the different LNs conditions was recorded. Regardless of the mosquito strain, the LNs containing PPF alone with as many as 30 holes drastically reduced the number of eggs laid by females succeeding in feeding, i.e. fecundity by 98% and egg hatching rate (fertility by 93% relative to untreated control net. Very few of the resistant females blood fed and survived under the Olyset® Duo with similar number of holes (up to 30 but of these few, the inhibition of reproductive success was 100%. There was no evidence that the Olyset® Duo LN with 150 holes impacted fecundity or fertility of the resistant colony. The efficacy of Olyset® Duo is encouraging and clearly illustrates that this new net might be a promising tool for malaria transmission control and resistance management.

Insecticidal and sterilizing effect of Olyset Duo®, a permethrin and pyriproxyfen mixture net against pyrethroid-susceptible and -resistant strains of Anopheles gambiae s.s.: a release-recapture assay in experimental huts.

Science.gov (United States)

Djènontin, Armel; Ahoua Alou, Ludovic P; Koffi, Alphonsine; Zogo, Barnabas; Duarte, Elves; N'Guessan, Raphael; Moiroux, Nicolas; Pennetier, Cédric

2015-01-01

In the context of the widespread distribution of pyrethroid resistance among malaria vectors, we did a release-recapture trial in experimental huts to investigate the insecticidal and sterilizing effects of a novel long-lasting net (LN), Olyset® Duo, incorporating a mixture of permethrin (PER) and the insect growth regulator (IGR), pyri-proxyfen (PPF). An LN containing PPF alone and a classic Olyset® Net were tested in parallel as positive controls. The effect of progressive number of holes (6, 30, or 150) that may accrue in nets over time was simulated. We used two laboratory Anopheles gambiae s.s. strains: the susceptible Kisumu strain and the pyrethroid-resistant VK-Per strain having solely kdr as resistance mechanism. The effect of these nets on the reproductive success of blood-fed females that survived the different LNs conditions was recorded. Regardless of the mosquito strain, the LNs containing PPF alone with as many as 30 holes drastically reduced the number of eggs laid by females succeeding in feeding, i.e. fecundity by 98% and egg hatching rate (fertility) by 93% relative to untreated control net. Very few of the resistant females blood fed and survived under the Olyset® Duo with similar number of holes (up to 30) but of these few, the inhibition of reproductive success was 100%. There was no evidence that the Olyset® Duo LN with 150 holes impacted fecundity or fertility of the resistant colony. The efficacy of Olyset® Duo is encouraging and clearly illustrates that this new net might be a promising tool for malaria transmission control and resistance management. © A. Djènontin et al., published by EDP Sciences, 2015.

Avaliação de Coberturas de Cabanas de Maternidade em Sistema Intensivo de Suínos Criados ao Ar Livre (Siscal, no Verão Maternity Hut Covering Evaluation in Outdoor Pig Production System, Summer Data

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Paulo Giovanni de Abreu

2001-12-01

Full Text Available O objetivo deste trabalho foi estudar as condições térmicas ambientais de diferentes materiais de cobertura de cabana de maternidade, no verão, utilizando os seguintes tratamentos: 1 cabana de maternidade coberta com fécula de isopor 2 cabana de maternidade coberta com isolamento de alumínio 3 cabana de maternidade coberta com tela e capim na cobertura 4 cabana de maternidade coberta com lona e capim na cobertura 5 ambiente ao ar livre e 6 à sombra da árvore. O delineamento experimental usado foi em blocos casualizados, em esquema de parcelas subdivididas, com 6 tratamentos nas parcelas, 5 horas nas subparcelas e 3 repetições. A categoria animal utilizada foi porcas lactantes, Landrace x Large White, distribuídas aleatoriamente por ordem de parto. Foi determinada a Umidade Relativa do Ar (UR, a Velocidade do Ar, a Temperatura Ambiente (Ta e foram calculados o Índice de Temperatura de Globo e Umidade (ITGU e a Carga Térmica Radiante (CTR. Apesar de os materiais utilizados como cobertura de maternidade terem melhorado o conforto térmico das porcas em relação as condições ambientais, ainda, não foram suficientes em atender as condições ideais de conforto térmico.The objective of this study was to evaluate the environmental thermal conditions of different maternity hut covering materials, in the summer period through the following treatments: 1 maternity hut with polystyrene fecula covering 2 maternity hut with isolation of aluminum covering 3 maternity hut with screen and grass covering 4 maternity hut with canvas and grass covering 5 outdoor environment 6 under shade a tree. The six treatments were arranged in a randomized split-plot design where the six treatments were in the plot with five schedules hours in the subplots and three replicates. Sow lactantes Landrace x Large White were alloted at random considering farrowing order. Relative Humidity Air (RH, Air Speed, and Environmental Temperature (Te data were determined

Indoor residual spraying with a mixture of clothianidin (a neonicotinoid insecticide and deltamethrin provides improved control and long residual activity against pyrethroid resistant Anopheles gambiae sl in Southern Benin.

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Corine Ngufor

Full Text Available There is an urgent need for new insecticides for indoor residual spraying (IRS which can provide improved and prolonged control of malaria vectors that have developed resistance to existing insecticides. The neonicotinoid, clothianidin represents a class of chemistry new to public health. Clothianidin acts as an agonist on nicotinic acetyl choline receptors. IRS with a mixture of Clothianidin and another WHO approved insecticide such as deltamethrin could provide improved control of insecticide resistant malaria vector populations and serve as a tool for insecticide resistance management.The efficacy and residual activity of a novel IRS mixture of deltamethrin and clothianidin was evaluated against wild pyrethroid resistant An. gambiae sl in experimental huts in Cove, Benin. Two application rates of the mixture were tested and comparison was made with clothianidin and deltamethrin applied alone. To assess the residual efficacy of the treatments on different local wall substrates, the inner walls of the experimental huts were covered with either cement, mud or plywood.Clothianidin demonstrated a clear delayed expression in mortality of wild pyrethroid resistant An. gambiae sl in the experimental huts which reached its full effect 120 hours after exposure. Overall mortality over the 12-month hut trial was 15% in the control hut and 24-29% in the deltamethrin-treated huts. The mixture of clothianidin 200mg/m2 and deltamethrin 25mg/m2 induced high overall hut mortality rates (87% on mud walls, 82% on cement walls and 61% on wooden walls largely due to the clothianidin component and high hut exiting rates (67-76% mostly due to the deltamethrin component. Mortality rates remained >80% for 8-9 months on mud and cement walls. The residual activity trend was confirmed by results from monthly in situ cone bioassays with laboratory susceptible An. gambiae Kisumu strain.IRS campaigns with the mixture of clothianidin plus deltamethrin have the potential to

Indoor residual spraying with a mixture of clothianidin (a neonicotinoid insecticide) and deltamethrin provides improved control and long residual activity against pyrethroid resistant Anopheles gambiae sl in Southern Benin.

Science.gov (United States)

Ngufor, Corine; Fongnikin, Augustin; Rowland, Mark; N'Guessan, Raphael

2017-01-01

There is an urgent need for new insecticides for indoor residual spraying (IRS) which can provide improved and prolonged control of malaria vectors that have developed resistance to existing insecticides. The neonicotinoid, clothianidin represents a class of chemistry new to public health. Clothianidin acts as an agonist on nicotinic acetyl choline receptors. IRS with a mixture of Clothianidin and another WHO approved insecticide such as deltamethrin could provide improved control of insecticide resistant malaria vector populations and serve as a tool for insecticide resistance management. The efficacy and residual activity of a novel IRS mixture of deltamethrin and clothianidin was evaluated against wild pyrethroid resistant An. gambiae sl in experimental huts in Cove, Benin. Two application rates of the mixture were tested and comparison was made with clothianidin and deltamethrin applied alone. To assess the residual efficacy of the treatments on different local wall substrates, the inner walls of the experimental huts were covered with either cement, mud or plywood. Clothianidin demonstrated a clear delayed expression in mortality of wild pyrethroid resistant An. gambiae sl in the experimental huts which reached its full effect 120 hours after exposure. Overall mortality over the 12-month hut trial was 15% in the control hut and 24-29% in the deltamethrin-treated huts. The mixture of clothianidin 200mg/m2 and deltamethrin 25mg/m2 induced high overall hut mortality rates (87% on mud walls, 82% on cement walls and 61% on wooden walls) largely due to the clothianidin component and high hut exiting rates (67-76%) mostly due to the deltamethrin component. Mortality rates remained >80% for 8-9 months on mud and cement walls. The residual activity trend was confirmed by results from monthly in situ cone bioassays with laboratory susceptible An. gambiae Kisumu strain. IRS campaigns with the mixture of clothianidin plus deltamethrin have the potential to provide

Pengaruh Strategi Diferensiasi Terhadap Loyalitas Konsumen Melalui Kepuasan Konsumen Pada Restoran Pizza Hut Di Medan

OpenAIRE

Utami, Desty Arief

2016-01-01

Competition among the companies which produce fast food today is highly competitive. One of the techniques to able to compete is by providing satisfaction to consumers effectively in order to obtain new customers and maintain old customers and by carrying out differentiation strategy as what has been done by Pizza Hut Restaurant in Medan. The aim of differentiation is to facilitate the facilitation of strong value for a product, and it is expected that consumers realize its value so that it c...

Interzonal air and moisture transport through large horizontal openings in a full-scale two-story test-hut: Part 2 - CFD study

Energy Technology Data Exchange (ETDEWEB)

Vera, S. [Department of Building, Civil and Environmental Engineering, Concordia University, 1455 de Maisonneuve Blvd. West, Montreal, Quebec (Canada); Department of Construction Engineering and Management, Pontificia Universidad Catolica de Chile, Av. Vicuna Mackenna 4860, San Agustin building, 3rd floor, Campus San Joaquin, Macul, Santiago 6904411 (Chile); Fazio, P.; Rao, J. [Department of Building, Civil and Environmental Engineering, Concordia University, 1455 de Maisonneuve Blvd. West, Montreal, Quebec (Canada)

2010-03-15

The aim of this paper is to study the air and moisture transport through a large horizontal opening in a full-scale two-story test-hut with mixed ventilation by means of computational fluid dynamics (CFD) simulations. CFD allows extending the experimental study presented in the companion paper and overcoming some limitations of experimental data. More than 80 cases were simulated for conditions similar to those tested experimentally and for additional ventilation rates and temperature difference between the two rooms. CFD simulations were performed in Airpak and the indoor zero-equation turbulence model was used. The CFD model was extensively validated with the distributions of air speed, temperature and humidity ratio measured across the two rooms, as well as with the measured interzonal mass airflows through the horizontal opening. CFD simulation results show that temperature difference between the two rooms and ventilation rate strongly influence the interzonal mass airflows through the opening when the upper room is colder than the lower room, while warm convective air currents from the baseboard heater and from the moisture source placed in the lower room cause upward mass airflows when the upper room is warmer than the lower room. Finally, empirical relationships between the upward mass airflow and the temperature difference between the two rooms are developed. (author)

"Conical Hut": A Basic Form of House Types in Timor Island

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Y. R. Chen

2015-08-01

Full Text Available Timor Island situates in the southeast end of Southeast Asia. The island accommodates many ethnic groups, which produce many diverse house types. As visiting East Timor in 2012 and Timor Island in 2014, we found the “Pair- House Type” widely spread over Timor Island. Uma Lulik (holy house, accommodating the ancestry soul, fireplace and elder’s bed, and Uma Tidor (house for sleep, containing living, sleeping and working space, compose the pair-house. The research team visited 14 ethnic groups and their houses, some of which were measured and drawn into 3D models as back to Taiwan. Uma Tidors of each ethnic group are quite similar with rectangular volume and hip roof, however, one of the fourteen ethnic groups can build cylinder houses for Uma Tidor. Uma Luliks of different ethnic groups are diversified and special. One group of the Uma Luliks shows a rectangular or square volume sheltered by a hip roof. The other group of Uma Luliks presents a non-specific volume under a conical roof, that we called the “conical hut”. Seven ethnic groups, Atoni, Weimua, Makassae, Mambai, Bunaq, Kemak and Bekais, have built “conical huts” for the use of Uma Lulik. People of the seven ethnic groups can construct a reasonable structural system to support the conical roof, and take good advantage of the space under the conical roof to meet their sacred needs and everyday life. “Conical Hut” may be regarded as the basic form of the house types adopted by the seven ethnic groups. It contains the basic spatial limits and the formal properties that the construction systems have to follow. Based on the concise rules of the basic form, people of each ethnic group use their talents, skills and building materials to generate variations of “conical hut”, which are different in house scale, spatial layout, construction system and form. The “conical huts” contain the consistency that all the huts come from the basic form, meanwhile, they also present

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

Science.gov (United States)

Logvinov, Ilana

2014-03-01

Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection. Copyright © 2014 Elsevier Inc. All rights reserved.

Measurements of experimental precision for trials with cowpea (Vigna unguiculata L. Walp.) genotypes.

Science.gov (United States)

Teodoro, P E; Torres, F E; Santos, A D; Corrêa, A M; Nascimento, M; Barroso, L M A; Ceccon, G

2016-05-09

The aim of this study was to evaluate the suitability of statistics as experimental precision degree measures for trials with cowpea (Vigna unguiculata L. Walp.) genotypes. Cowpea genotype yields were evaluated in 29 trials conducted in Brazil between 2005 and 2012. The genotypes were evaluated with a randomized block design with four replications. Ten statistics that were estimated for each trial were compared using descriptive statistics, Pearson correlations, and path analysis. According to the class limits established, selective accuracy and F-test values for genotype, heritability, and the coefficient of determination adequately estimated the degree of experimental precision. Using these statistics, 86.21% of the trials had adequate experimental precision. Selective accuracy and the F-test values for genotype, heritability, and the coefficient of determination were directly related to each other, and were more suitable than the coefficient of variation and the least significant difference (by the Tukey test) to evaluate experimental precision in trials with cowpea genotypes.

Experimental burn plot trial in the Kruger National Park: history, experimental design and suggestions for data analysis

Directory of Open Access Journals (Sweden)

R. Biggs

2003-12-01

Full Text Available The experimental burn plot (EBP trial initiated in 1954 is one of few ongoing long-termfire ecology research projects in Africa. The trial aims to assess the impacts of differentfire regimes in the Kruger National Park. Recent studies on the EBPs have raised questions as to the experimental design of the trial, and the appropriate model specificationwhen analysing data. Archival documentation reveals that the original design was modified on several occasions, related to changes in the park's fire policy. These modifications include the addition of extra plots, subdivision of plots and changes in treatmentsover time, and have resulted in a design which is only partially randomised. The representativity of the trial plots has been questioned on account of their relatively small size,the concentration of herbivores on especially the frequently burnt plots, and soil variation between plots. It is suggested that these factors be included as covariates inexplanatory models or that certain plots be excluded from data analysis based on resultsof independent studies of these factors. Suggestions are provided for the specificationof the experimental design when analysing data using Analysis of Variance. It is concluded that there is no practical alternative to treating the trial as a fully randomisedcomplete block design.

Clinical Trials of an Experimental Ebola Vaccine: A Canadian ...

International Development Research Centre (IDRC) Digital Library (Canada)

This initiative supports phases 2 and 3 clinical trials of an experimental Ebola vaccine. The experimental vaccine is based on an attenuated recombinant Vesicular Stomatitis Virus vector (VSV-EBOV). The Public Health Agency of Canada developed the vaccine and licensed it to NewLink Genetics and Merck. Early vaccine ...

Independent power source hybrid system - recent examples mainly of mountain huts.; Dokuritsu dengengata no haiburiddo shisutemu -saikin no yamagoya deno jirei wo chushin ni.

Energy Technology Data Exchange (ETDEWEB)

Mori, T. [Kanagawa Inst. of Tech., Kanagawa (Japan)

2000-09-30

History of the independent power source hybrid systems used at such as mountain huts were outlined, and recent application examples of the hybrid systems were explained. At Natsuzawa mineral spring in Nagano pref., 7 kW of hybrid power generator system composed of solar cell and wind power generator, as well as 400 W of small hydraulic power generator are working supplying electric power for the private sewerage system, and the system without diesel generator is being tested. At Senjogahara refuge hut in South Alps, a hybrid power generation system composed of 10.7 kW of solar cell and 6.4 kW of wind power generator was installed, and is working. In mountainous area, there exist critical factors such as weather condition and difficulty in carrying equipment, accordingly, cost reduction and sizing down of relevant apparatus such as batteries and inverters are expected. (NEDO)

Testing devices or experimental systems? Cancer clinical trials take the genomic turn.

Science.gov (United States)

Nelson, Nicole C; Keating, Peter; Cambrosio, Alberto; Aguilar-Mahecha, Adriana; Basik, Mark

2014-06-01

Clinical trials are often described as machine-like systems for generating specific information concerning drug safety and efficacy, and are understood as a component of the industrial drug development processes. This paper argues that contemporary clinical trials in oncology are not reducible to mere drug testing. Drawing on ethnographic fieldwork and interviews with researchers in the field of oncology from 2010 to 2013, we introduce a conceptual contrast between trials as testing machines and trials as clinical experimental systems to draw attention to the ways trials are increasingly being used to ask open-ended scientific questions. When viewed as testing machines, clinical trials are seen as a means to produce answers to straightforward questions and deviations from the protocol are seen as bugs in the system; but practitioners can also treat trials as clinical experimental systems to investigate as yet undefined problems and where heterogeneity becomes a means to produce novel biological or clinical insights. The rise of "biomarker-driven" clinical trials in oncology, which link measurable biological characteristics such as genetic mutations to clinical features such as a patient's response to a particular drug, exemplifies a trend towards more experimental styles of clinical work. These transformations are congruent with changes in the institutional structure of clinical research in oncology, including a movement towards more flexible, networked research arrangements, and towards using individual patients as model systems for asking biological questions. Copyright © 2014 Elsevier Ltd. All rights reserved.

Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial.

Science.gov (United States)

Diop, Ayisha; Daff, Bocar; Sow, Maimouna; Blum, Jennifer; Diagne, Mamadou; Sloan, Nancy L; Winikoff, Beverly

2016-01-01

Access to injectable uterotonics for management of postpartum haemorrhage remains limited in Senegal outside health facilities, and misoprostol and oxytocin delivered via Uniject have been deemed viable alternatives in community settings. We aimed to compare the efficacy of these drugs when delivered by auxiliary midwives at maternity huts. We did an unmasked cluster-randomised controlled trial at maternity huts in three districts in Senegal. Maternity huts with auxiliary midwives located 3-21 km from the closest referral centre were randomly assigned (1:1; via a computer-generated random allocation overseen by Gynuity Health Projects) to either 600 μg oral misoprostol or 10 IU oxytocin in Uniject (intramuscular), stratified by reported previous year clinic volume (deliveries) and geographical location (inland or coastal). Maternity huts that had been included in a previous study of misoprostol for prevention of postpartum haemorrhage were excluded to prevent contamination. Pregnant women in their third trimester were screened for eligibility either during community outreach or at home-based prenatal visits. Only women delivered by the auxiliary midwives in the maternity huts were eligible for the study. Women with known allergies to prostaglandins or pregnancy complications were excluded. The primary outcome was mean change in haemoglobin concentration measured during the third trimester and after delivery. This study was registered with ClinicalTrials.gov, number NCT01713153. 28 maternity hut clusters were randomly assigned-14 to the misoprostol group and 14 to the oxytocin group. Between June 6, 2012, and Sept 21, 2013, 1820 women were recruited. 647 women in the misoprostol group and 402 in the oxytocin group received study drug and had recorded pre-delivery and post-delivery haemoglobin concentrations, and overall 1412 women delivered in the study maternity huts. The mean change in haemoglobin concentrations was 3·5 g/L (SD 16·1) in the misoprostol group

Indoor application of attractive toxic sugar bait (ATSB in combination with mosquito nets for control of pyrethroid-resistant mosquitoes.

Directory of Open Access Journals (Sweden)

Zachary P Stewart

Full Text Available BACKGROUND: Attractive toxic sugar bait (ATSB sprayed onto vegetation has been successful in controlling Anopheles mosquitoes outdoors. Indoor application of ATSB has yet to be explored. The purpose of this study was to determine whether ATSB stations positioned indoors have the potential to kill host-seeking mosquitoes and constitute a new approach to control of mosquito-borne diseases. METHODS: Insecticides were mixed with dyed sugar solution and tested as toxic baits against Anopheles arabiensis, An. Gambiae s.s. and Culex quinquefasciatus in feeding bioassay tests to identify suitable attractant-insecticide combinations. The most promising ATSB candidates were then trialed in experimental huts in Moshi, Tanzania. ATSB stations were hung in huts next to untreated mosquito nets occupied by human volunteers. The proportions of mosquitoes killed in huts with ATSB treatments relative to huts with non-insecticide control treatments huts were recorded, noting evidence of dye in mosquito abdomens. RESULTS: In feeding bioassays, chlorfenapyr 0.5% v/v, boric acid 2% w/v, and tolfenpyrad 1% v/v, mixed in a guava juice-based bait, each killed more than 90% of pyrethroid-susceptible An. Gambiae s.s. and pyrethroid-resistant An. arabiensis and Cx. quinquefasciatus. In the hut trial, mortality rates of the three ATSB treatments ranged from 41-48% against An. arabiensis and 36-43% against Cx. quinquefasciatus and all were significantly greater than the control mortalities: 18% for An. arabiensis, 7% for Cx. quinquefasciatus (p<0.05. Mortality rates with ATSB were comparable to those with long lasting insecticidal nets previously tested against the same species in this area. CONCLUSIONS: Indoor ATSB shows promise as a supplement to mosquito nets for controlling mosquitoes. Indoor ATSB constitute a novel application method for insecticide classes that act as stomach poisons and have not hitherto been exploited for mosquito control. Combined with LLIN, indoor

PV plants for Alpine huts: Installation and operating experience at seven ENEL plants

International Nuclear Information System (INIS)

Belli, G.; Iliceto, A.; Previ, A.

1988-01-01

The problem of supplying electric power to isolated users far from the electricity distribution grid is one of general interest. Such consumers are nowadays generally supplied with electricity produced by small diesel generator-sets, and only recently have photovoltaic arrays and wind-turbines offered an alternative to the internal combustion engine. ENEL, as a State-owned electricity utility, is interested in the development of this particular application of renewable energy sources. Enlarging a low-voltage distribution network to connect consumers whose power requirements are extremely low (about 1000 kWh/year) may, in certain conditions, be uneconomical, both for the utility, which has to absorb most of the expense involved in construction and maintenance, and for the consumer himself. The paper reports the design criteria, the tests and the problems encountered in electrifying seven alpine huts belonging to CAI (Italian Alpine Club)

UKRAINIAN HUT IN PROVERBS AND SAYINGS

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LAHDAN S. P

2016-07-01

Full Text Available Raising of problem. In modern Ukrainian society, which is undergoing a national renaissance, greatly deepened interest in the symbols of material and spiritual culture as a form of identification and identity. Inseparable from life as language, song, were and are proverbs and sayings. As an expression of acute intelligence people, aesthetic preferences, high morality, humor, accuracy, wit and strength, wisdom and beauty of poetic language, they accompany mankind from antiquity and enrich the new generation. Valuable signs of Ukrainian culture proverbs are also the fact that generally have exemplary character, as giving advice, caution, warn, approve, condemn. Based on rich experience, proverbs reflect all sectors of the Ukrainian people, especially bright life, habits, lifestyle and mentality. The most important element of life without which you cannot imagine life before and today is the house - the personification of his native home, family, independence, well-being and hospitality. In the beginning attached great importance to the house, she was treated with great respect, ordered decorated holiday and protected. It found expression in many proverbs and sayings. These samples of folk wisdom affecting the eternal themes so do not lose their relevance today. Their research makes it possible to understand the deeper spirituality, especially the outlook of the Ukrainian people. Purpose. To find out the semantics of the component "khata" in the proverbs and sayings identify productivity in shaping Ukrainian folklore. Conclusion. Proverbs and sayings of the component "hut" reflect various spheres of life Ukrainian: the organization of life, family relationships, moral and ethical code, mentality, especially social relations. Home is inseparable from its inhabitants, becoming masters of character, its appearance characterizes the attitude of the hosts it, the house represents those relationships that have developed between family members

Efficacy of PermaNet® 3.0 and PermaNet® 2.0 nets against laboratory-reared and wild Anopheles gambiae sensu lato populations in northern Tanzania.

Science.gov (United States)

Kweka, Eliningaya J; Lyaruu, Lucile J; Mahande, Aneth M

2017-01-18

Mosquitoes have developed resistance against pyrethroids, the only class of insecticides approved for use on long-lasting insecticidal nets (LLINs). The present study sought to evaluate the efficacy of the pyrethroid synergist PermaNet® 3.0 LLIN versus the pyrethroid-only PermaNet® 2.0 LLIN, in an East African hut design in Lower Moshi, northern Tanzania. In this setting, resistance to pyrethroid insecticides has been identified in Anopheles gambiae mosquitoes. Standard World Health Organization bioefficacy evaluations were conducted in both laboratory and experimental huts. Experimental hut evaluations were conducted in an area where there was presence of a population of highly pyrethroid-resistant An. arabiensis mosquitoes. All nets used were subjected to cone bioassays and then to experimental hut trials. Mosquito mortality, blood-feeding inhibition and personal protection rate were compared between untreated nets, unwashed LLINs and LLINs that were washed 20 times. Both washed and unwashed PermaNet® 2.0 and PermaNet® 3.0 LLINs had knockdown and mortality rates of 100% against a susceptible strain of An. gambiae sensu stricto. The adjusted mortality rate of the wild mosquito population after use of the unwashed PermaNet® 3.0 and PermaNet® 2.0 nets was found to be higher than after use of the washed PermaNet® 2.0 and PermaNet® 3.0 nets. Given the increasing incidence of pyrethroid resistance in An. gambiae mosquitoes in Tanzania, we recommend that consideration is given to its distribution in areas with pyrethroid-resistant malaria vectors within the framework of a national insecticide-resistance management plan.

Microrandomized trials: An experimental design for developing just-in-time adaptive interventions.

Science.gov (United States)

Klasnja, Predrag; Hekler, Eric B; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A

2015-12-01

This article presents an experimental design, the microrandomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals' health behaviors. Microrandomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. The article describes the microrandomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Microrandomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Microrandomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions' effects, enabling creation of more effective JITAIs. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

Differential substrate subsidence of the EnviHUT project pitched extensive green roof

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Nečadová Klára

2017-01-01

Full Text Available In primary phase of testing building physical characteristics of the EnviHUT project extensive and semi-intensive roofs with 30° inclination occurred exceptional substrate subsidence. An extensive testing field with retaining geocell-system evinced differential subsidence of individual sectors after six months. Measured subsidence of installed substrate reached 40 % subsidence compared to originally designed height (intended layer thickness. Subsequent deformation of geocell-system additionally caused partial slide of substrate to drip edge area. These slides also influenced initial development of stonecrop plants on its surface. Except functional shortages the aesthetical function of the whole construction is influenced by the mentioned problem. The stated paper solves mentioned issues in view of installation method optimization, selection and modification of used roof substrate and in view of modification of geometric and building installed elements retaining system arrangement. Careful adjustment of roof system geometry and enrichment of original substrate fraction allow full functionality from pitched extensive green roof setting up. The modification scheme and its substantiation is a part of this technical study output.

UKRAINIAN HUT AS THE ARCHETYPAL MODEL IN THE WORKS OF ALEXANDER DOVZHENKO

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YEVSEYEVA H. P.

2016-04-01

Full Text Available Raising of problem. Archetypal model of national dwelling is the basic and determining element of material and spiritual culture, because design features, decorative artwork, ornamentation housing, amulet symbols as elements of the home’s interior structure the ideological system and act as a kind of code for understanding the primary landmark of the national worldview. The purpose. Identify the main components of the design features of the Ukrainian house image on the material of the story "Izba" and the tale "the Enchanted Desna" Alexander Dovzhenko. Conclusions. Research of reproduction features of the Ukrainian hut image in the art world of Alexander Dovzhenko allowed to structure arhetipo model of national dwelling, which appears as the center of the universe and as the source of all organic life forms. Antagonism of the profane and of the sacred can be solved through a paradoxical focus of such binary oppositions as power/spiritual strength, closeness/openness. An important means of the essential characteristics revealing of the house image is the apophaticism device.

[HSP90 inhibitor 17-AAG plays an important role in JAK3/STAT5 signaling pathways in HTLV-1 infection cell line HUT-102].

Science.gov (United States)

Yang, Q Q; Tan, H; Fu, Z P; Ma, Q; Song, J L

2017-08-14

Objective: To analyze whether heat-shock protein 90 (HSP90) be involved in a permanently abnormal activated JAK/STAT signaling in ATL cells in vitro. Methods: The effect of 17-AAG on proliferation of ATL cell lines HUT-102 was assessed using CCK8 at different time points. Cell apoptosis was measured by flow cytometry. The specific proteins HSP90, STAT5, p-STAT5 and JAK3 were detected by Western blotting. Results: Overexpression of HSP90 in HUT-102 cell lines was disclosed ( P AAG led to reduced cell proliferation, but there was no significant change in terms of cell proliferation when the concentration of 17-AAG between 2 000-8 000 nmol/L ( P >0.05) . 17-AAG induced cell apoptosis in different time-points and concentrations. 17-AAG don't affect the expression of JAK3 gene. Conclusion: This study indicated that JAK3 as HSP90 client protein was aberrantly activated in HTLV-1-infected T-cell lines, leading to constitutive activation of p-STAT5 in JAK/STAT signal pathway, which demonstrated that HSP90-inhibitors 17-AAG inhibited the growth of HTLV-1-infected T-cell lines by reducing cell proliferation and inducing cell apoptosis.

Micro-Randomized Trials: An Experimental Design for Developing Just-in-Time Adaptive Interventions

Science.gov (United States)

Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.

2015-01-01

Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463

Insecticide resistance profile of Anopheles gambiae from a phase II field station in Cové, southern Benin: implications for the evaluation of novel vector control products.

Science.gov (United States)

Ngufor, Corine; N'Guessan, Raphael; Fagbohoun, Josias; Subramaniam, Krishanthi; Odjo, Abibatou; Fongnikin, Augustin; Akogbeto, Martin; Weetman, David; Rowland, Mark

2015-11-18

Novel indoor residual spraying (IRS) and long-lasting insecticidal net (LLIN) products aimed at improving the control of pyrethroid-resistant malaria vectors have to be evaluated in Phase II semi-field experimental studies against highly pyrethroid-resistant mosquitoes. To better understand their performance it is necessary to fully characterize the species composition, resistance status and resistance mechanisms of the vector populations in the experimental hut sites. Bioassays were performed to assess phenotypic insecticide resistance in the malaria vector population at a newly constructed experimental hut site in Cové, a rice growing area in southern Benin, being used for WHOPES Phase II evaluation of newly developed LLIN and IRS products. The efficacy of standard WHOPES-approved pyrethroid LLIN and IRS products was also assessed in the experimental huts. Diagnostic genotyping techniques and microarray studies were performed to investigate the genetic basis of pyrethroid resistance in the Cové Anopheles gambiae population. The vector population at the Cové experimental hut site consisted of a mixture of Anopheles coluzzii and An. gambiae s.s. with the latter occurring at lower frequencies (23 %) and only in samples collected in the dry season. There was a high prevalence of resistance to pyrethroids and DDT (>90 % bioassay survival) with pyrethroid resistance intensity reaching 200-fold compared to the laboratory susceptible An. gambiae Kisumu strain. Standard WHOPES-approved pyrethroid IRS and LLIN products were ineffective in the experimental huts against this vector population (8-29 % mortality). The L1014F allele frequency was 89 %. CYP6P3, a cytochrome P450 validated as an efficient metabolizer of pyrethroids, was over-expressed. Characterizing pyrethroid resistance at Phase II field sites is crucial to the accurate interpretation of the performance of novel vector control products. The strong levels of pyrethroid resistance at the Cové experimental hut

Phase 3 Oncology Clinical Trials in South Africa: Experimentation or Therapeutic Misconception?

Science.gov (United States)

Malan, Tina; Moodley, Keymanthri

2016-02-01

Although clinical research in oncology is vital to improve current understanding of cancer and to validate new treatment options, voluntary informed consent is a critical component. Oncology research participants are a particularly vulnerable population; hence, therapeutic misconception often leads to ethical and legal challenges. We conducted a qualitative study administering semi-structured questionnaires on 29 adult, Phase 3, oncology clinical trial participants at three different private oncology clinical trial sites in South Africa. A descriptive content analysis was performed to identify perceptions of these participants regarding Phase 3 clinical trials. We found that most participants provided consent to be included in the trial for self-benefit. More than half of the participants had a poor understanding of Phase 3 clinical trials, and almost half the participants believed the clinical trial did not pose any significant risk to them. The word "hope" was used frequently by participants, displaying clear optimism with regard to the clinical trial and its outcome. This indicated that therapeutic misconception does occur in the South African oncology research setting and has the potential to lead to underestimation of the risks of a Phase 3 clinical trial. Emphasizing the experimental nature of a clinical trial during the consent process is critical to address therapeutic misconception in oncology research. © The Author(s) 2016.

The impact of free trial acceptance on demand for alternative nicotine products: evidence from experimental auctions.

Science.gov (United States)

Rousu, Matthew C; O'Connor, Richard J; Bansal-Travers, Maansi; Pitcavage, James M; Thrasher, James F

2015-06-11

This study explored the relationship between product trials and consumer demand for alternative nicotine products (ANP). An experimental auction was conducted with 258 adult smokers, wherein participants were randomly assigned to one of four experimental conditions. The participants received the opportunity to try, but did not have to accept, one of three relatively novel ST products (i.e., snus, dissolvable tobacco, or medicinal nicotine), or they were placed into a control group (i.e., no trial). All the participants then bid on all three of these products, as well as on cigarettes. We assessed interest in using ANP based on both trial of the product and bids placed for the products in the experimental auction. Fewer smokers were willing to try snus (44%) than dissolvable tobacco (64%) or medicine nicotine (68%). For snus, we find modest evidence suggesting that willingness to try is associated with greater demand for the product. For dissolvable tobacco or medicinal nicotine, we find no evidence that those who accept the product trial have higher demand for the product. Free trials of a novel ANP were not strongly associated with product demand, as assessed by willingness to pay. Given the debate over the potential for ANP to reduce the harm from smoking, these results are important in understanding the impact of free trial offers on adoption of ST product as a strategy to reduce harm from tobacco use.

A 2 MW, 170 GHz coaxial cavity gyrotron - experimental verification of the design of main components

Energy Technology Data Exchange (ETDEWEB)

Piosczyk, B [Forschungszentrum Karlsruhe, Association EURATOM-FZK, Institut fuer Hochleistungsimpuls- und Mikrowellentechnik (IHM), Postfach 3640, D-76021 Karlsruhe (Germany); Dammertz, G [Forschungszentrum Karlsruhe, Association EURATOM-FZK, Institut fuer Hochleistungsimpuls- und Mikrowellentechnik (IHM), Postfach 3640, D-76021 Karlsruhe (Germany); Dumbrajs, O [Department of Engineering Physics and Mathematics, Helsinki University of Technology, Association EURATOM-TEKES, FIN-02150 Espoo (Finland)] (and others)

2005-01-01

A 2 MW, CW, 170 GHz coaxial cavity gyrotron is under development in cooperation between European Research Institutions (FZK Karlsruhe, CRPP Lausanne, HUT Helsinki) and the European tube industry (TED, Velizy, France). The design of critical components has recently been examined experimentally at FZK Karlsruhe with a short pulse ({approx} few ms) coaxial cavity gyrotron. This gyrotron uses the same cavity and the same quasioptical (q.o.) RF-output system as designed for the industrial prototype and a very similar electron gun.

Implications of medical devices quality assurance for implementation of experimental clinical trials

International Nuclear Information System (INIS)

Tirindelli Danesi, D.; Altavista, P.; Marino, C.; Benassi, M.

1992-01-01

The basis for all controlled clinical trials is the comparison of a new treatment with the standard treatment. The effect of the experimental procedure on the natural history of the disease is the result observed; but the interpretation of the results in cancer clinical experimentation is often difficult due to the variability of the clinical course of individual cancers in a given category. It has been possible to categorize cancers by means of prognostic factors and evaluate the results of therapy within each prognostic category, but there is still much variability within each category. The only way to determine whether or not a new treatment can be used for a particular form of cancer is to try it out on patients in clinical trials. The cooperative practice was originally induced by the realistic need for large sample sizes, but the variability in the interpretation of the results increased due to difficulties in comparing data. This is one of the main problems in cancer literature. These problems originate from inconsistent or incomplete reporting of the patient population under study, the treatment administered, the statistical methods employed to assess treatment efficacy and from differences in the definition of response criteria. This paper tries to outline the impact on the results evaluation of the lack of standardized prognostic factors and standardized therapeutic modalities in the selection and treatment of patients included in clinical trials

Investigation of the concrete foundation of the old living hut built in 1969 at Syowa Station, Antarctic

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Takayuki Hirai

2002-09-01

Full Text Available Concrete specimens taken from the pier of the concrete foundation of the old living hut built in 1969 at Syowa Station, Antarctica, were brought back to Japan for investigation of deterioration conditions. This concrete was made by mixing alumina cement brought from Japan with gravel, sand, and water removed from melted snow, all taken from the surface ground of East Ongul Island on which Syowa Station is located, and by placing and shaping it into permanent form. The pier concrete is examined by composition analysis, compressive strength test and neutralization depth measurement of the cored sample. Transformation of the hydration products of alumina cement, from CAH10 to C3AH6 and AH3, was found to be completed. The maximum neutralization depth was found to be 26 mm. In addition, the compressive strength decreased by 22% from the time of construction as judged from a specimen at construction time. Based on these observations, deterioration of the concrete is in progress, but not to the extent that either its strength or durability is a problem with regard to serviceability.

Application of PCM energy storage in combination with night ventilation for space cooling

International Nuclear Information System (INIS)

Barzin, Reza; Chen, John J.J.; Young, Brent R.; Farid, Mohammed M.

2015-01-01

Highlights: • Night ventilation were tested in combination with PCM-impregnated gypsum boards. • The Price-based method were experimentally used to perform peak load shifting. • Importance of the application of a smart control were experimentally investigated. • A cost and energy saving up to 93% and 92% per day respectively were achieved. - Abstract: In recent years, as a result of the continuous increase in energy demand, the use of energy storage has become increasingly important. To address this problem, the application of phase change materials (PCM) in buildings has received attention because of their high energy storage density and their ease of incorporation in building envelopes. Despite large experimental works conducted on the application phase change materials in buildings, there is very little work done on this application in combination with night ventilation. In this study, the application of night ventilation in combination with PCM-impregnated gypsum boards for cooling purposes was experimentally investigated. Two identical test huts equipped with “smart” control systems were used for testing the concept. One hut was constructed using impregnated gypsum boards, while the other hut was finished with ordinary gypsum board. Initially an air conditioning (AC) unit, without night ventilation, was used in both huts to charge the PCM during low peak period, showing very little savings in electricity. However, when night ventilation was used to charge the PCM instead, a weekly electricity saving of 73% was achieved.

The patient's safety and access to experimental drugs after the termination of clinical trials: regulations and trends.

Science.gov (United States)

da Silva, Ricardo Eccard; Amato, Angélica Amorim; Sousa, Thiago do Rego; de Carvalho, Marta Rodrigues; Novaes, Maria Rita Carvalho Garbi

2018-05-12

Participants' rights and safety must be guaranteed not only while a clinical trial is being conducted but also when a clinical trial finishes. The criteria for post-trial access to experimental drugs, however, are unclear in various countries. The objectives of this study were (i) to ascertain if there were regulations or guidelines related to patients' access to drugs after the end of clinical trials in the countries selected in the study and (ii) to analyze trends in post-trial access in countries classified by their level of economic development. This study is a retrospective review. The data are from the records of clinical trials from 2014 registered in the World Health Organization's International Clinical Trials Registry Platform (ICTRP) database. Among the countries selected, provision of drugs post-trial is mandatory only in Argentina, Brazil, Chile, Finland, and Peru. The plans for post-trial access tend to be more present in low- and middle-income and upper middle-income countries, in comparison with high-income countries. Studies involving vulnerable populations are 2.53 times more likely to have plans for post-trial access than studies which do not. The guaranteeing of post-trial access remains mandatory in few countries. Considering that individuals seen as vulnerable have been included in clinical trials without plans for post-trial access, stakeholders must discuss the need to develop regulations mandating the guaranteeing of post-trial access in specified situations.

The activity of the pyrrole insecticide chlorfenapyr in mosquito bioassay: towards a more rational testing and screening of non-neurotoxic insecticides for malaria vector control.

Science.gov (United States)

Oxborough, Richard M; N'Guessan, Raphael; Jones, Rebecca; Kitau, Jovin; Ngufor, Corine; Malone, David; Mosha, Franklin W; Rowland, Mark W

2015-03-24

The rapid selection of pyrethroid resistance throughout sub-Saharan Africa is a serious threat to malaria vector control. Chlorfenapyr is a pyrrole insecticide which shows no cross resistance to insecticide classes normally used for vector control and is effective on mosquito nets under experimental hut conditions. Unlike neurotoxic insecticides, chlorfenapyr owes its toxicity to disruption of metabolic pathways in mitochondria that enable cellular respiration. A series of experiments explored whether standard World Health Organization (WHO) guidelines for evaluation of long-lasting insecticidal nets, developed through testing of pyrethroid insecticides, are suitable for evaluation of non-neurotoxic insecticides. The efficacy of WHO recommended cone, cylinder and tunnel tests was compared for pyrethroids and chlorfenapyr. To establish bioassay exposure times predictive of insecticide-treated net (ITN) efficacy in experimental hut trials, standard three-minute bioassays of pyrethroid and chlorfenapyr ITNs were compared with longer exposures. Mosquito behaviour and response to chlorfenapyr ITN in bioassays conducted at night were compared to day and across a range of temperatures representative of highland and lowland transmission. Standard three-minute bioassay of chlorfenapyr produced extremely low levels of mortality compared to pyrethroids. Thirty-minute day-time bioassay produced mortality closer to hut efficacy of chlorfenapyr ITN but still fell short of the WHO threshold. Overnight tunnel test with chlorfenapyr produced 100% mortality and exceeded the WHO threshold of 80%. The endogenous circadian activity rhythm of anophelines results in inactivity by day and raised metabolism and flight activity by night. A model which explains improved toxicity of chlorfenapyr ITN when tested at night, and during the day at higher ambient temperature, is that activation of chlorfenapyr and disruption of respiratory pathways is enhanced when the insect is more metabolically

The effects of McDonalds, Kentucky Fried Chicken and Pizza Hut meals on recommended diets.

Science.gov (United States)

Malouf, N M; Colagiuri, S

1995-06-01

The objective was to study the effect of three common takeaway meals on recommended healthy diets. New South Wales Department of Health recommended diets of 5020, 6275, 9205 and 12,540 kilojoules were used. An evening meal from each of these diets was substituted with one of three common fast food chain takeaway meals 1, 2, 3 and 5 times per week. The 3 takeaway meals were from McDonalds, Pizza Hut and Kentucky Fried Chicken. The effects of each of these meals on average daily kilojoule, fibre, fat, P/S ratio, protein and carbohydrate intakes were assessed. The takeaway meals were high in fat and kilojoules and low in fibre and therefore contravened the Dietary Guidelines for Australians. Addition of these meals increased average kilojoule consumption and the percentage energy contribution of fat and decreased the P/S ratio and fibre intake. The magnitude of these deleterious effects was directly proportional to the number of times the meals were included each week and inversely proportional to the energy content of the diet. The adverse effects were greatest with the McDonalds and Kentucky Fried Chicken meals. Takeaway meals may be convenient but the meals which were tested were too high in fat and kilojoules and too low in fibre to be a regular part of a balanced diet. Even one takeaway meal per week adversely affects the lower kilojoule recommended healthy diets.

Translocations (5;17) and (7;17) in patients with de novo or therapy-related myelodysplastic syndromes or acute nonlymphocytic leukemia. A possible association with acquired pseudo-Pelger-Hut anomaly and small vacuolated granulocytes

International Nuclear Information System (INIS)

La, J.L.Z.; Zandecki, M.; Fenaux, P.; Le Baron, F.; Bauters, F.; Cosson, A.; Deminatti, M.

1990-01-01

Twelve patients [two with de novo myelodysplastic syndrome (MDS), four with secondary MDS, five with de novo acute nonlymphocytic leukemia (ANLL), one with secondary ANLL] showed a 17p deletion resulting from translocations involving 17p: t(5;17)(p11;p11) in four cases, t(7;17)(p11;p11) in six cases, complex (5;17)(q23;p12) translocation with dicentric chromosome in one case, and t(17;?)(p11-12;?) in the remaining patient. All these structural anomalies were observed in hypodiploid clones associated with total or partial monosomy of chromosomes 5 and 7 (12 cases), monosomy 12 (five cases), monosomy 3 (four cases), and monosomy 4 (three cases). Median survival was only 3.3 months (range 3 days to 8 months). Striking features were observed in bone marrow mature granulocytes: all but one case had a pseudo-Pelger-Hut anomaly in a significant number of granulocytes, and eight patients had granulocytes with reduced size and clear cytoplasmic vacuoles. Careful cytological review of 51 patients with MDS or ANLL and various cytogenetic anomalies was performed for comparison: vacuolated granulocytes were a very uncommon finding. On the other hand, eight patients had a pseudo-Pelger-Hut anomaly, which correlated significantly with total monosomy 17 in these patients. A possible correlation between cytological anomalies and cytogenetic data is discussed, and the role of 17p in the nuclear segmentation of granulocytes is stressed

Considerations that may influence the result of trials assessing tensile strength in experimental surgery Considerações que podem influir no resultado de pesquisas que avaliam a resistência tênsil em cirurgia experimental

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Lucas Félix Rossi

2007-12-01

Full Text Available PURPOSE: To provide information gathered upon the execution of trials assessing tensile strength in experimental surgeries. METHODS: Descriptive study considering details on the execution of trials assessing tensile strength in experimental surgery. RESULTS: The analysis of the rupture force in a mechanical test machine is an adequate technique since it provides precise and quick results. It can, undoubtedly, be developed in this context of the eminently mechanical analysis of trials on experimental surgery. CONCLUSION: The utilization of a mechanical test machine is a useful tool in the assessment of materials' strength, providing accurate results. Nevertheless the trials must be well structured analyzing the multiple variables so as to attain a pattern of constant reproducibility and to provide the necessary reliability.OBJETIVO: Fornecer informações advindas da experiência com a realização de trabalhos que avaliam a resistência tênsil em cirurgia experimental. MÉTODOS: Estudo descritivo considerando detalhes da execução de trabalhos que avaliam a resistência tênsil em cirurgia experimental. RESULTADOS: A análise da força de ruptura em máquina de ensaios mecânicos é uma técnica apropriada e que fornece resultados precisos e rápidos. Pode ser desenvolvida neste contexto da análise eminentemente mecânica de estudos em cirurgia experimental. CONCLUSÃO: A utilização da máquina de ensaios mecânicos é uma ferramenta útil na avaliação da resistência de materiais fornecendo resultados precisos. Entretanto os trabalhos devem ser estruturados analisando múltiplas variáveis para alcançar um padrão de reprodutibilidade constante e trazer a confiabilidade necessária ao estudo.

What's in a Trial? On the Importance of Distinguishing Between Experimental Lab Studies and Randomized Controlled Trials: The Case of Cognitive Bias Modification and Alcohol Use Disorders.

Science.gov (United States)

Wiers, Reinout W; Boffo, Marilisa; Field, Matt

2018-05-01

Recently, the National Institutes of Health (NIH) redefined clinical trials to include any study involving behavioral or biomedical interventions. In line with a general framework from experimental medicine, we argue that it is crucial to distinguish between experimental laboratory studies aimed at revealing psychological mechanisms underlying behavior and randomized controlled trials (RCTs) in clinical samples aimed at testing the efficacy of an intervention. As an illustration, we reviewed the current state of the evidence on the efficacy of cognitive bias modification (CBM) interventions in alcohol use disorders. A recent meta-analysis "cast serious doubts on the clinical utility of CBM interventions for addiction." That analysis combined experimental laboratory studies and RCTs. We demonstrated that, when studies are differentiated regarding study type (experimental laboratory study or RCT), mode of delivery (controlled experiment or Internet), and population (healthy volunteers or patients), the following effects are found: (a) short-lived effects of CBM on drinking behavior in experimental laboratory studies in students, but only when the bias is successfully manipulated; (b) small but robust effects of CBM on treatment outcome when administered as an adjunct to established treatments in clinical settings in RCTs with alcohol-dependent patients; and (c) nonspecific effects (reduced drinking irrespective of condition) in RCTs of CBM administered online to problem drinkers. We discuss how CBM might be improved when it is better integrated into regular treatment, especially cognitive behavioral therapy, and we conclude that disregarding the difference between experimental laboratory studies and RCTs can lead to invalid conclusions.

Field evaluation of the bio-efficacy of three pyrethroid based coils against wild populations of anthropophilic mosquitoes in Northern Tanzania

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Shandala Msangi

2010-01-01

Full Text Available Aims: This study aims to assess the feeding inhibition and repellency effect of three brands of mosquito coils in experimental huts (East African design. Evaluated products were all pyrethroid-based mosquito coils - Kiboko; , Total; and Risasi; . Mosfly (0.1% D-allethrin was a positive control. Indoor resting behavior, feeding inhibition and induced exophily were measured as responses of burnt coil smoke in huts. Materials and methods: Resting mosquitoes were collected inside the huts, in window traps and verandah traps using mechanical aspirators. Identified to species level and sex. Results: A total of 1460 mosquitoes were collected, 58.9% (n=860 were Anopheles gambiae s.l while 41.1% (n=600 Culex quinquefasciatus. Indoor resting mosquitoes in all treated huts were significantly reduced than in negative control (DF=4, F=18.6, P < 0.001. Species found to rest indoors were not statistical different between the positive control (Mosfly coil and other three treated huts (DF=3, F=1.068, P=0.408. Cx.quinquefasciatus had significantly higher induced exophily in all treatments comparing to An.gambiae s.l (DF=1, F=5.34, P=0.050. Comparison between species (An.gambiae s.l and Cx. quinquefasciatus for the feeding inhibition among treated huts was not statistically significant (DF=1, F=0.062, P=0.810. Conclusion: Introduction of several personal protection measures will be ideal to supplement the existing gap in reducing the man vector contacts hence lowering the disease transmission.

Sample size determinations for group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms.

Science.gov (United States)

Heo, Moonseong; Litwin, Alain H; Blackstock, Oni; Kim, Namhee; Arnsten, Julia H

2017-02-01

We derived sample size formulae for detecting main effects in group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms. Such designs are necessary when experimental interventions need to be administered to groups of subjects whereas control conditions need to be administered to individual subjects. This type of trial, often referred to as a partially nested or partially clustered design, has been implemented for management of chronic diseases such as diabetes and is beginning to emerge more commonly in wider clinical settings. Depending on the research setting, the level of hierarchy of data structure for the experimental arm can be three or two, whereas that for the control arm is two or one. Such different levels of data hierarchy assume correlation structures of outcomes that are different between arms, regardless of whether research settings require two or three level data structure for the experimental arm. Therefore, the different correlations should be taken into account for statistical modeling and for sample size determinations. To this end, we considered mixed-effects linear models with different correlation structures between experimental and control arms to theoretically derive and empirically validate the sample size formulae with simulation studies.

The importance of considering community-level effects when selecting insecticidal malaria vector products

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Coosemans Marc

2011-08-01

Full Text Available Abstract Background Insecticide treatment of nets, curtains or walls and ceilings of houses represent the primary means for malaria prevention worldwide. Direct personal protection of individuals and households arises from deterrent and insecticidal activities which divert or kill mosquitoes before they can feed. However, at high coverage, community-level reductions of mosquito density and survival prevent more transmission exposure than the personal protection acquired by using a net or living in a sprayed house. Methods A process-explicit simulation of malaria transmission was applied to results of 4 recent Phase II experimental hut trials comparing a new mosaic long-lasting insecticidal net (LLIN which combines deltamethrin and piperonyl butoxide with another LLIN product by the same manufacturer relying on deltamethrin alone. Results Direct estimates of mean personal protection against insecticide-resistant vectors in Vietnam, Cameroon, Burkina Faso and Benin revealed no clear advantage for combination LLINs over deltamethrin-only LLINs (P = 0.973 unless both types of nets were extensively washed (Relative mean entomologic inoculation rate (EIR ± standard error of the mean (SEM for users of combination nets compared to users of deltamethrin only nets = 0.853 ± 0.056, P = 0.008. However, simulations of impact at high coverage (80% use predicted consistently better impact for the combination net across all four sites (Relative mean EIR ± SEM in communities with combination nets, compared with those using deltamethrin only nets = 0.613 ± 0.076, P Conclusion Process-explicit simulations of community-level protection, parameterized using locally-relevant experimental hut studies, should be explicitly considered when choosing vector control products for large-scale epidemiological trials or public health programme procurement, particularly as growing insecticide resistance necessitates the use of multiple active ingredients.

Efficacy of PermaNet® 2.0 and PermaNet® 3.0 against insecticide-resistant Anopheles gambiae in experimental huts in Côte d'Ivoire

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Koffi Alphonsine A

2011-06-01

Full Text Available Abstract Background Pyrethroid resistance in vectors could limit the efficacy of long-lasting insecticidal nets (LLINs because all LLINs are currently treated with pyrethroids. The goal of this study was to evaluate the efficacy and wash resistance of PermaNet® 3.0 compared to PermaNet® 2.0 in an area of high pyrethroid in Côte d'Ivoire. PermaNet® 3.0 is impregnated with deltamethrin at 85 mg/m2 on the sides of the net and with deltamethrin and piperonyl butoxide on the roof. PermaNet® 2.0 is impregnated with deltamethrin at 55 mg/m2 across the entire net. Methods The study was conducted in the station of Yaokoffikro, in central Côte d'Ivoire. The efficacy of intact unwashed and washed LLINs was compared over a 12-week period with a conventionally-treated net (CTN washed to just before exhaustion. WHO cone bioassays were performed on sub-sections of the nets, using wild-resistant An. gambiae and Kisumu strains. Mosquitoes were collected five days per week and were identified to genus and species level and classified as dead or alive, then unfed or blood-fed. Results Mortality rates of over 80% from cone bioassays with wild-caught pyrethroid-resistant An. gambiae s.s were recorded only with unwashed PermaNet® 3.0. Over 12 weeks, a total of 7,291 mosquitoes were collected. There were significantly more An. gambiae s.s. and Culex spp. caught in control huts than with other treatments (P An. gambiae s.s and Culex spp, were lower for the control than for other treatments (P 0.05 except for unwashed PermaNet® 3.0 (P Conclusions This study showed that unwashed PermaNet® 3.0 caused significantly higher mortality against pyrethroid resistant An. gambiae s.s and Culex spp than PermaNet® 2.0 and the CTN. The increased efficacy with unwashed PermaNet® 3.0 over PermaNet® 2.0 and the CTN was also demonstrated by higher KD and mortality rates (KD > 95% and mortality rate > 80% in cone bioassays performed with wild pyrethroid-resistant An. gambiae s

Medidas do grau de precisão experimental em ensaios de competição de cultivares de milho Measures of experimental precision degree in corn cultivar competition trials

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Alberto Cargnelutti Filho

2009-02-01

Full Text Available O objetivo deste trabalho foi avaliar a adequação de algumas estatísticas como medidas do grau de precisão experimental, e as relações entre elas. Foram usados os dados de produtividade de grãos de 101 ensaios de competição de cultivares de milho (Zea mays L., realizados no Estado do Rio Grande do Sul, nos anos agrícolas 2002/2003, 2003/2004 e 2004/2005. Foi estudada a relação entre 12 estatísticas, estimadas para cada ensaio, e as análises de correlação de trilha e de agrupamento foram realizadas com base nessas estatísticas. Os limites de classe estabelecidos, a partir das estatísticas acurácia seletiva, herdabilidade, coeficiente de determinação e valor do teste F para cultivar, mostraram-se adequados para estimar o grau de precisão experimental de ensaios de competição de cultivares de milho. Por essas estatísticas, 89% dos ensaios de competição de cultivares de milho apresentaram precisão alta ou muito alta e 5% dos ensaios poderiam ser escartados em razão da insuficiência na precisão experimental. As estatísticas acurácia seletiva, herdabilidade, coeficiente de determinação e valor do teste F para cultivar têm relação direta entre si e são mais adequadas do que o coeficiente de variação e a diferença mínima significativa pelo teste de Tukey, em percentagem da média, para avaliação da precisão experimental em ensaios de competição de cultivares de milho.The objective of this work was to evaluate the appropriateness of some statistics as experimental precision measures and the relationships among them. Grain yield data from 101 cultivar competition trials of corn (Zea mays L., which were carried out in the Rio Grande do Sul state, Brazil, in the agricultural years 2002/2003, 2003/2004 and 2004/2005, were used. Relationship among 12 statistics, estimated from each trial, was studied and correlation, path and cluster analysis were calculated based on these statistics. Class limits established by

The entomopathogenic fungus Beauveria bassiana reduces instantaneous blood feeding in wild multi-insecticide-resistant Culex quinquefasciatus mosquitoes in Benin, West Africa

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Howard Annabel FV

2010-09-01

Full Text Available Abstract Background Mosquito-borne diseases are still a major health risk in many developing countries, and the emergence of multi-insecticide-resistant mosquitoes is threatening the future of vector control. Therefore, new tools that can manage resistant mosquitoes are required. Laboratory studies show that entomopathogenic fungi can kill insecticide-resistant malaria vectors but this needs to be verified in the field. Methods The present study investigated whether these fungi will be effective at infecting, killing and/or modifying the behaviour of wild multi-insecticide-resistant West African mosquitoes. The entomopathogenic fungi Metarhizium anisopliae and Beauveria bassiana were separately applied to white polyester window netting and used in combination with either a permethrin-treated or untreated bednet in an experimental hut trial. Untreated nets were used because we wanted to test the effect of fungus alone and in combination with an insecticide to examine any potential additive or synergistic effects. Results In total, 1125 female mosquitoes were collected during the hut trial, mainly Culex quinquefasciatus Say. Unfortunately, not enough wild Anopheles gambiae Giles were collected to allow the effect the fungi may have on this malaria vector to be analysed. None of the treatment combinations caused significantly increased mortality of Cx. quinquefasciatus when compared to the control hut. The only significant behaviour modification found was a reduction in blood feeding by Cx. quinquefasciatus, caused by the permethrin and B. bassiana treatments, although no additive effect was seen in the B. bassiana and permethrin combination treatment. Beauveria bassiana did not repel blood foraging mosquitoes either in the laboratory or field. Conclusions This is the first time that an entomopathogenic fungus has been shown to reduce blood feeding of wild mosquitoes. This behaviour modification indicates that B. bassiana could potentially be a new

The influence of a tilt training programme on the renin-angiotensin-aldosterone system activity in patients with vasovagal syncope.

Science.gov (United States)

Gajek, Jacek; Zyśko, Dorota; Krzemińska, Sylwia; Mazurek, Walentyna

2009-08-01

We assessed the influence of short-term and long-term tilt training on the activity of the renin-angiotensin-aldosterone system (RAAS) in vasovagal patients. Thirty-nine patients (28 F, 11 M) aged 39.7 +/- 11.2 years with a history of vasovagal syncope and a positive head-up tilt test (HUT) were studied. Blood samples for plasma renin activity (PRA) and aldosterone (ALDO) concentration were drawn at the baseline, immediately after HUT and 10 min after HUT, during the diagnostic, the negative short-term (2-5 days) follow-up HUT and long-term (1-3 months) follow-up HUT. Tilt training was started after diagnostic HUT. In diagnostic HUT, PRA increased significantly immediately after HUT comparing to the baseline, during recovery the values did not change. ALDO concentration increased after HUT comparing to baseline and further increased during recovery. After short-term tilt training, PRA and ALDO concentrations did not significantly change compared to their corresponding values in diagnostic HUT. After long-term tilt training, PRA did not significantly change compared to the values in the diagnostic and short-term follow-up HUT. ALDO concentration also did not change significantly at the baseline and immediately after HUT, and 10 min after HUT ALDO concentration was significantly lower than after diagnostic HUT. Tilt training changes the response of RAAS to the prolonged orthostasis in vasovagal patients. The coupling between PRA and ALDO after diagnostic HUT has been found to be altered and the physiological relationship was restored after long-term tilt training. The beneficial effect of tilt training depends partially on changed RAAS activation.

Intervention on whole grain with healthy balanced diet to manage childhood obesity (GReat-Child™trial): study protocol for a quasi-experimental trial.

Science.gov (United States)

Koo, H C; Poh, B K; Ruzita, Abd Talib

2016-01-01

The rapid increase in childhood obesity is a serious public health problem, and has led to the development of many interventions. However, no intervention has emphasized whole grains as a strategy to manage childhood obesity. Therefore, this article describes the protocol of a 12-week multi-component, family-based intervention on whole grain, using a healthy balanced diet for managing childhood obesity. The GReat-Child trial utilize a quasi-experimental method in which two schools in Kuala Lumpur are assigned to intervention and control groups. The eligibility criteria are overweight/obese children, aged 9 through 11 years, who has no serious co-morbidities. The children who report consuming whole-grain foods in their 3-day diet-recall during the screening will be excluded. The study sample is characterized by anthropometric measurements (weight, height, percentage of body fat and waist circumference), whole grain and nutrient intakes (3-day 24-h diet recalls), and their knowledge, attitudes and practices towards whole grain. The 12-week intervention is comprised of three components addressing behaviour, personal and environmental factors, based on social cognitive theory: (1) individual diet counselling for the parents; (2) six 30-min nutrition education classes and (3) school delivery of whole-grain foods; The control school does not receive any interventions, however, for ethical purposes, a health talk is conducted after the entire GReat-Child Trial is completed. The GReat-Child trial represents a novel approach to examining the effectiveness of the intervention of whole grain in a healthy balanced diet on managing childhood obesity. We anticipate that this trial will reveal not only whether whole grain intervention will be effective in managing childhood obesity, but also provide greater insights into the acceptance of whole grain among Malaysian children.

Small-scale field evaluation of push-pull system against early- and outdoor-biting malaria mosquitoes in an area of high pyrethroid resistance in Tanzania [version 1; referees: 2 approved

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Arnold S. Mmbando

2017-11-01

Full Text Available Background: Despite high coverage of indoor interventions like insecticide-treated nets, mosquito-borne infections persist, partly because of outdoor-biting, early-biting and insecticide-resistant vectors. Push-pull systems, where mosquitoes are repelled from humans and attracted to nearby lethal targets, may constitute effective complementary interventions. Methods: A partially randomized cross-over design was used to test efficacy of push-pull in four experimental huts and four local houses, in an area with high pyrethroid resistance in Tanzania. The push-pull system consisted of 1.1% or 2.2% w/v transfluthrin repellent dispensers and an outdoor lure-and-kill device (odour-baited mosquito landing box. Matching controls were set up without push-pull. Adult male volunteers collected mosquitoes attempting to bite them outdoors, but collections were also done indoors using exit traps in experimental huts and by volunteers in the local houses. The collections were done hourly (1830hrs-0730hrs and mosquito catches compared between push-pull and controls. An. gambiae s.l. and An. funestus s.l. were assessed by PCR to identify sibling species, and ELISA to detect Plasmodium falciparum and blood meal sources. Results: Push-pull in experimental huts reduced outdoor-biting for An. arabiensis and Mansonia species by 30% and 41.5% respectively. However, the reductions were marginal and insignificant for An. funestus (12.2%; p>0.05 and Culex (5%; p>0.05. Highest protection against all species occurred before 2200hrs. There was no significant difference in number of mosquitoes inside exit traps in huts with or without push-pull. In local households, push-pull significantly reduced indoor and outdoor-biting of An. arabiensis by 48% and 25% respectively, but had no effect on other species. Conclusion: This push-pull system offered modest protection against outdoor-biting An. arabiensis, without increasing indoor mosquito densities. Additional experimentation

The Susceptibility and Behavioral Response of Anopheles Albimanus Weidemann and Anopheles Vestitipennis Dyar and Knab (Diptera: Culicidae) to Insecticides in Northern Belize, Central America

National Research Council Canada - National Science Library

Bangs, Michael J

1999-01-01

During a 9-month study (1995-1996) in Caledonia Village, northern Belize, anopheline mosquitoes collected off human-bait and from experimental huts were evaluated for their susceptibility and behavioral responses to DDT and deltamethrin...

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

Science.gov (United States)

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

Measuring effectiveness, efficiency and equity in an experimental Payments for Ecosystem Services trial.

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Martin, Adrian; Gross-Camp, Nicole; Kebede, Bereket; McGuire, Shawn

2014-09-01

There is currently a considerable effort to evaluate the performance of Payments for Ecosystem Services as an environmental management tool. The research presented here contributes to this work by using an experimental design to evaluate Payments for Ecosystem Services as a tool for supporting biodiversity conservation in the context of an African protected area. The trial employed a 'before and after' and 'with and without' design. We present the results of social and ecological surveys to investigate the impacts of the trial in terms of its effectiveness, efficiency and equity. We find the scheme to be effective at bringing about additional conservation outcomes. However, we also found that increased monitoring is similarly effective in the short term, at lower cost. The major difference - and arguably the significant contribution of the Payments for Ecosystem Services - was that it changed the motives for protecting the park and improved local perceptions both of the park and its authority. We discuss the implications of these results for conservation efficiency, arguing that efficiency should not be defined in terms of short-term cost-effectiveness, but also in terms of the sustainability of behavioral motives in the long term. This insight helps us to resolve the apparent trade-off between goals of equity and efficiency in Payments for Ecosystem Services.

Understanding noninferiority trials

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Seokyung Hahn

2012-11-01

Full Text Available Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

Traditional and innovative experimental and clinical trial designs and their advantages and pitfalls.

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Weimer, Katja; Enck, Paul

2014-01-01

Many study designs and design variants have been developed in the past to either overcome or enhance drug-placebo differences in clinical trials or to identify and characterize placebo responders in experimental studies. They share many commonalities as well as differences that are discussed here: the role of deception and ethical restrictions, habituation effects and the control of the natural course of disease, assay sensitivity testing and effective blinding, acceptability and motivation of patients and volunteers, and the development of individualized medicine. These are fostered by two opposite strategies: utilizing the beneficial aspects of the placebo response-and avoiding its negative counterpart, the nocebo effect-in medical routine for the benefit of patients, and minimizing-by controlling-the negative aspects of the placebo effect during drug development.

Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea

Science.gov (United States)

Sissoko, Daouda; Laouenan, Cedric; Folkesson, Elin; M’Lebing, Abdoul-Bing; Beavogui, Abdoul-Habib; Baize, Sylvain; Camara, Alseny-Modet; Maes, Piet; Shepherd, Susan; Danel, Christine; Carazo, Sara; Conde, Mamoudou N.; Gala, Jean-Luc; Colin, Géraldine; Savini, Hélène; Bore, Joseph Akoi; Le Marcis, Frederic; Koundouno, Fara Raymond; Petitjean, Frédéric; Lamah, Marie-Claire; Diederich, Sandra; Tounkara, Alexis; Poelart, Geertrui; Berbain, Emmanuel; Dindart, Jean-Michel; Duraffour, Sophie; Lefevre, Annabelle; Leno, Tamba; Peyrouset, Olivier; Irenge, Léonid; Bangoura, N’Famara; Palich, Romain; Hinzmann, Julia; Kraus, Annette; Barry, Thierno Sadou; Berette, Sakoba; Bongono, André; Camara, Mohamed Seto; Chanfreau Munoz, Valérie; Doumbouya, Lanciné; Souley Harouna; Kighoma, Patient Mumbere; Koundouno, Fara Roger; Réné Lolamou; Loua, Cécé Moriba; Massala, Vincent; Moumouni, Kinda; Provost, Célia; Samake, Nenefing; Sekou, Conde; Soumah, Abdoulaye; Arnould, Isabelle; Komano, Michel Saa; Gustin, Lina; Berutto, Carlotta; Camara, Diarra; Camara, Fodé Saydou; Colpaert, Joliene; Delamou, Léontine; Jansson, Lena; Kourouma, Etienne; Loua, Maurice; Malme, Kristian; Manfrin, Emma; Maomou, André; Milinouno, Adele; Ombelet, Sien; Sidiboun, Aboubacar Youla; Verreckt, Isabelle; Yombouno, Pauline; Bocquin, Anne; Carbonnelle, Caroline; Carmoi, Thierry; Frange, Pierre; Mely, Stéphane; Nguyen, Vinh-Kim; Pannetier, Delphine; Taburet, Anne-Marie; Treluyer, Jean-Marc; Kolie, Jacques; Moh, Raoul; Gonzalez, Minerva Cervantes; Kuisma, Eeva; Liedigk, Britta; Ngabo, Didier; Rudolf, Martin; Thom, Ruth; Kerber, Romy; Gabriel, Martin; Di Caro, Antonino; Wölfel, Roman; Badir, Jamal; Bentahir, Mostafa; Deccache, Yann; Dumont, Catherine; Durant, Jean-François; El Bakkouri, Karim; Gasasira Uwamahoro, Marie; Smits, Benjamin; Toufik, Nora; Van Cauwenberghe, Stéphane; Ezzedine, Khaled; Dortenzio, Eric; Pizarro, Louis; Etienne, Aurélie; Guedj, Jérémie; Fizet, Alexandra; Barte de Sainte Fare, Eric; Murgue, Bernadette; Tran-Minh, Tuan; Rapp, Christophe; Piguet, Pascal; Poncin, Marc; Draguez, Bertrand; Allaford Duverger, Thierry; Barbe, Solenne; Baret, Guillaume; Defourny, Isabelle; Carroll, Miles; Raoul, Hervé; Augier, Augustin; Eholie, Serge P.; Yazdanpanah, Yazdan; Levy-Marchal, Claire; Antierrens, Annick; Van Herp, Michel; Günther, Stephan; de Lamballerie, Xavier; Keïta, Sakoba; Mentre, France

2016-01-01

Background Ebola virus disease (EVD) is a highly lethal condition for which no specific treatment has proven efficacy. In September 2014, while the Ebola outbreak was at its peak, the World Health Organization released a short list of drugs suitable for EVD research. Favipiravir, an antiviral developed for the treatment of severe influenza, was one of these. In late 2014, the conditions for starting a randomized Ebola trial were not fulfilled for two reasons. One was the perception that, given the high number of patients presenting simultaneously and the very high mortality rate of the disease, it was ethically unacceptable to allocate patients from within the same family or village to receive or not receive an experimental drug, using a randomization process impossible to understand by very sick patients. The other was that, in the context of rumors and distrust of Ebola treatment centers, using a randomized design at the outset might lead even more patients to refuse to seek care. Therefore, we chose to conduct a multicenter non-randomized trial, in which all patients would receive favipiravir along with standardized care. The objectives of the trial were to test the feasibility and acceptability of an emergency trial in the context of a large Ebola outbreak, and to collect data on the safety and effectiveness of favipiravir in reducing mortality and viral load in patients with EVD. The trial was not aimed at directly informing future guidelines on Ebola treatment but at quickly gathering standardized preliminary data to optimize the design of future studies. Methods and Findings Inclusion criteria were positive Ebola virus reverse transcription PCR (RT-PCR) test, age ≥ 1 y, weight ≥ 10 kg, ability to take oral drugs, and informed consent. All participants received oral favipiravir (day 0: 6,000 mg; day 1 to day 9: 2,400 mg/d). Semi-quantitative Ebola virus RT-PCR (results expressed in “cycle threshold” [Ct]) and biochemistry tests were performed at day 0

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

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Rufin eVanRullen

2011-04-01

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

Effect of aging and adhesive durability on panel plywood of the old living hut built in 1969 at Syowa Station, Antarctica

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Hirotsugu Sekiguchi

2002-09-01

Full Text Available We herein report on an evaluation of durability of plywood of the old living hut built in 1969 brought back to Japan in terms of adhesiveness as well as adhesive strength between of wooden frame and plywood. Measuring water absorption percentage of test samples taken from wooden panel, we tested on adhesive bonding between veneers and compressed shearing of plywood and wooden frame ,and then measure their adhesive bonding. As a result, we conclude that plywood used for interior obtains high adhesive strength due to low water absorption percentage of the plywood on the other hand, the absorption strength of plywood for exterior is remarkably weakened because of the high water absorption percentage. In addition to that, since adhesive strength between panel plywood and wooden frame is stronger than that of between veneers, epoxy resin is suitable, yet we recognized that adhesion specs on metal panel for exterior should be reviewed in future. After all, weakened adhesive strength of plywood is mainly caused by moisture content in the plywood, and in order to improve panel durability, it is necessary to prevent wooden materials from rising moisture content with countermeasures of incoming of snow melting water, anti-condensation , and anti-rust of steel plate for exterior wall, as well as improve performance of water resisting adhesive.

Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial: A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea.

Directory of Open Access Journals (Sweden)

Daouda Sissoko

2016-03-01

Full Text Available Ebola virus disease (EVD is a highly lethal condition for which no specific treatment has proven efficacy. In September 2014, while the Ebola outbreak was at its peak, the World Health Organization released a short list of drugs suitable for EVD research. Favipiravir, an antiviral developed for the treatment of severe influenza, was one of these. In late 2014, the conditions for starting a randomized Ebola trial were not fulfilled for two reasons. One was the perception that, given the high number of patients presenting simultaneously and the very high mortality rate of the disease, it was ethically unacceptable to allocate patients from within the same family or village to receive or not receive an experimental drug, using a randomization process impossible to understand by very sick patients. The other was that, in the context of rumors and distrust of Ebola treatment centers, using a randomized design at the outset might lead even more patients to refuse to seek care. Therefore, we chose to conduct a multicenter non-randomized trial, in which all patients would receive favipiravir along with standardized care. The objectives of the trial were to test the feasibility and acceptability of an emergency trial in the context of a large Ebola outbreak, and to collect data on the safety and effectiveness of favipiravir in reducing mortality and viral load in patients with EVD. The trial was not aimed at directly informing future guidelines on Ebola treatment but at quickly gathering standardized preliminary data to optimize the design of future studies.Inclusion criteria were positive Ebola virus reverse transcription PCR (RT-PCR test, age ≥ 1 y, weight ≥ 10 kg, ability to take oral drugs, and informed consent. All participants received oral favipiravir (day 0: 6,000 mg; day 1 to day 9: 2,400 mg/d. Semi-quantitative Ebola virus RT-PCR (results expressed in "cycle threshold" [Ct] and biochemistry tests were performed at day 0, day 2, day 4, end

The importance of communication in promoting voluntary participation in an experimental trial: A qualitative study based on the assessment of the gamma-interferon test for the diagnosis of bovine tuberculosis in France.

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Clémence Boireau

Full Text Available Understanding the factors leading each stakeholder to participate in an experimental trial is a key element for improving trial set-up and for identifying selection bias in statistical analyses. An experimental protocol, validated by the European Commission, was developed in France to assess the ability of the gamma-interferon test in terms of accuracy to replace the second intradermal skin test in cases of suspected bovine tuberculosis. Implemented between 2013 and 2015, this experimental trial was based on voluntary participation. To determine and understand the motivation or reluctance of farmers to take part in this trial, we carried out a sociological survey in France. Our study was based on semi-structured interviews with the farmers and other stakeholders involved. The analysis of findings demonstrated that shortening the lock-up period during tuberculosis suspicion, following the use of a gamma-interferon test, was an important aim and a genuine challenge for the animal health stakeholders. However, some farmers did not wish to continue the trial because it could potentially have drastic consequences for them. Moreover, misunderstandings and confusion concerning the objectives and consequences of the trial led stakeholders to reject it forcefully. Based on our results, we offer some recommendations: clear and appropriate communication tools should be prepared to explain the protocol and its aims. In addition, these types of animal health trials should be designed with the stakeholders' interests in mind. This study provides a better understanding of farmer motivations and stakeholder influences on trial participation and outcomes. The findings can be used to help design trials so that they promote participation by farmers and by all animal health stakeholders in general.

Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

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Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

2018-02-01

Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

[Effects of fructose on triglycerides in individuals with diabetes: a Meta-analysis of experimental trials].

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Xiang, Xuesong; Zhao, Jia; Zhu, Jing; Zhang, Peng; Wang, Zhu; Yang, Yuexin

2015-05-01

To assess the effects of fructose on the blood triglycerides, particularly examining treatment dose, duration, and control of food in individuals with diabetes. A systematic review and Meta-analysis of experimental clinical trials were conducted to investigate the effect of isocaloric fructose exchange for carbohydrate on triglycerides, total cholesterol. MedLine, EMBASE, The Cochrane Library, CMBdisc, CNKI (1970-2014), and some related journals were searched. Heterogeneity was assessed by 2 tests and quantified by I2. Meta-analysis was conducted by RevMan 5.3. 15 reports (21 trials) met the eligibility criteria. Isocaloric fructose exchange for carbohydrate raised triglycerides under specific conditions in individuals with type 2 diabetes. A triglyceride-raising effect without heterogeneity was seen only in type 2 diabetes when the dose was ≥ 100 g fructose/d (WMD 0.17, 95% CI0.08 - 0.25, P triglyceride-raising effect with heterogeneity was seen in type 2 diabetes when the reference carbohydrate was starch (WMD 0.13, 95% CI 0.02 - 0.23 , P = 0.02). Effect of fructose on the level of TG in type 2 diabetes patients is more sensitive than that in type 1 diabetes. The effect on triglycerides is dose dependent and depends on what kinds of carbohydrate is being exchanged with fructose.

Mitochondrial Replacement Therapy: Halachic Considerations for Enrolling in an Experimental Clinical Trial

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Tendler, Rabbi Moshe D.; Loike, John D.

2015-01-01

The transition of new biotechnologies into clinical trials is a critical step in approving a new drug or therapy in health care. Ethically recruiting appropriate volunteers for these clinical trials can be a challenging task for both the pharmaceutical companies and the US Food and Drug Administration. In this paper we analyze the Jewish halachic perspectives of volunteering for clinical trials by focusing on an innovative technology in reproductive medicine, mitochondrial replacement therapy. The halachic perspective encourages individuals to volunteer for such clinical trials under the ethical principles of beneficence and social responsibility, when animal studies have shown that health risks are minimal. PMID:26241230

Mitochondrial Replacement Therapy: Halachic Considerations for Enrolling in an Experimental Clinical Trial

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Rabbi Moshe D. Tendler

2015-07-01

Full Text Available The transition of new biotechnologies into clinical trials is a critical step in approving a new drug or therapy in health care. Ethically recruiting appropriate volunteers for these clinical trials can be a challenging task for both the pharmaceutical companies and the US Food and Drug Administration. In this paper we analyze the Jewish halachic perspectives of volunteering for clinical trials by focusing on an innovative technology in reproductive medicine, mitochondrial replacement therapy. The halachic perspective encourages individuals to volunteer for such clinical trials under the ethical principles of beneficence and social responsibility, when animal studies have shown that health risks are minimal.

The impact of product information and trials on demand for smokeless tobacco and cigarettes: evidence from experimental auctions.

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Rousu, Matthew C; O'Connor, Richard J; Thrasher, James F; June, Kristie M; Bansal-Travers, Maansi; Pitcavage, James

2014-03-01

Epidemiological and toxicological evidence suggests lower risk of smokeless tobacco (ST) products compared to cigarettes. Less is known, however, about consumer perceptions and use of novel forms of ST, including snus and dissolvable tobacco. In this study, we conducted in-person experimental auctions in Buffalo, NY, Columbia, SC, and Selinsgrove, PA with 571 smokers to test the impact of information and product trials on smokers' preferences. Auctions were conducted between November 2010-November 2011. We found no evidence of an impact of product trials on demand in our auctions. Anti-ST information increased demand for cigarettes when presented alone, but when presented with pro-ST information it decreased demand for cigarettes. It did not decrease demand for ST products. Anti-smoking information increased demand for ST products, but did not affect cigarette demand. These findings suggest that credible and effective communications about tobacco harm reduction should reinforce the negative effects of smoking. Copyright © 2013 Elsevier Inc. All rights reserved.

Spatial Repellency and the Field Evaluation of a Push-Pull Strategy for the Control of Malaria Vectors in Northern Belize, Central America

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2014-09-18

monitoring of knocked down mosquitoes. To control for residual chemical contamination from repellent treatments, all huts and interception traps were...to discontinue any ongoing trial if the institution is found to have contravened any of the above conditions. 7. The applicant shall cover food ...albopictus (Skuse) from Selangor, Malaysia . Trap Biomed 30:220-30 31. Cherington E, Ek E, Cho P, Burgess F, Hernandez B, et al. 2010. Forest Cover and

Comparative study of radon concentration in selected modern and traditional building at Kenyatta University

International Nuclear Information System (INIS)

Chege, W.M.; Rathore, I.V.S.; Chhabra, S.C.; Mustapha, A.O.

2010-01-01

Radon is leading source of radiation exposure to the public and increases risk of cancer (UNSCEAR, 2000). There is general lack of data on indoor radon in Kenya especially on building design-traditional versus modern. In rural Kenya traditional mud huts coexist with modern stone building. Indoor radon found to vary widely in Kenya: Mustapha et al (2002): 5-1200 Bqm3, Maina et al (2004): 5-704 Bqm3. None of previous works indicates radon variation with building design. The aim of the current study is to compare radon concentrations in coexisting stone buildings and mud huts. Such data would be useful in formulation of policies regarding housing, as part of radon data base in Kenya Experimental Techniques Characteristic of selected buildings: Traditional Huts: Single roomed, Wall made of wood and plastered using mud, bare floor and no ceiling, grass-thatched or mud plastered, doors and windows remained open during the sampling period. Modern Buildings: (Classes used to represent modern building). Those made of natural stone, wooden floor, ceiling, doors and windows remained shut during the sampling period. Measurement of Radon Concentration Radon sampling was done using Charcoal canisters (EPA type). They were activated, and then exposed simultaneously at sampling sites for 48 hours. Analysis and data acquisition was done using NaI(Tl) gamma-ray spectrometer. Radon concentration was calculated based on gamma rays emitted by 214Pb (295 and 352 keV) and 214Bi (609 keV). 13 Results and Discussion Radon levels were higher in classrooms and significantly high in huts. Mean (Bqm-3 ) Minimum (Bqm-3 ) Maximum (Bqm-3 ). Traditional huts had 170.3 15.6 30.2 315.4 while modern buildings had 193 ±19.3 115.76 257.2. There were higher levels in classroom despite lower levels of 226Ra (50.18 Bqkg-1) in natural stone. Possible source of high concentrations: - radon seeping in through floor boards building up over time as building more closed up - Radon concentration was more varied

The impact of trial runs on the acceptability of pigouvian taxes: experimental evidence

Energy Technology Data Exchange (ETDEWEB)

Cherry, Todd L.; Kallbekken, Steffen; Kroll, Stephen

2011-07-01

This paper examines the political difficulty of enacting welfare-enhancing Pigouvian taxes. Using referenda in a market experiment with externalities, we investigate the effect of trial periods on the acceptability of two theoretically equivalent variants of Pigouvian taxes. While implementing either tax is in subjects material self-interest, we find significant levels of opposition to both tax schemes, though the level differs considerably. Results show that trial runs can overcome initial tax aversion, significantly increasing acceptability. The effect is robust across tax schemes, but a trial with one scheme does not affect the acceptability of the other. Trial periods also mitigate initial biases in preferences of alternative tax schemes. (auth)

Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials.

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Schroen, Anneke T; Petroni, Gina R; Wang, Hongkun; Gray, Robert; Wang, Xiaofei F; Cronin, Walter; Sargent, Daniel J; Benedetti, Jacqueline; Wickerham, Donald L; Djulbegovic, Benjamin; Slingluff, Craig L

2010-08-01

A major challenge for randomized phase III oncology trials is the frequent low rates of patient enrollment, resulting in high rates of premature closure due to insufficient accrual. We conducted a pilot study to determine the extent of trial closure due to poor accrual, feasibility of identifying trial factors associated with sufficient accrual, impact of redesign strategies on trial accrual, and accrual benchmarks designating high failure risk in the clinical trials cooperative group (CTCG) setting. A subset of phase III trials opened by five CTCGs between August 1991 and March 2004 was evaluated. Design elements, experimental agents, redesign strategies, and pretrial accrual assessment supporting accrual predictions were abstracted from CTCG documents. Percent actual/predicted accrual rate averaged per month was calculated. Trials were categorized as having sufficient or insufficient accrual based on reason for trial termination. Analyses included univariate and bivariate summaries to identify potential trial factors associated with accrual sufficiency. Among 40 trials from one CTCG, 21 (52.5%) trials closed due to insufficient accrual. In 82 trials from five CTCGs, therapeutic trials accrued sufficiently more often than nontherapeutic trials (59% vs 27%, p = 0.05). Trials including pretrial accrual assessment more often achieved sufficient accrual than those without (67% vs 47%, p = 0.08). Fewer exclusion criteria, shorter consent forms, other CTCG participation, and trial design simplicity were not associated with achieving sufficient accrual. Trials accruing at a rate much lower than predicted (accrual rate) were consistently closed due to insufficient accrual. This trial subset under-represents certain experimental modalities. Data sources do not allow accounting for all factors potentially related to accrual success. Trial closure due to insufficient accrual is common. Certain trial design factors appear associated with attaining sufficient accrual. Defining

Access to Experimental Cancer Drugs

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An experimental drug has been tested in the lab and with animals and approved for testing in people by the FDA, but can’t yet be advertised, sold, or prescribed. Experimental drugs may be available through clinical trials or expanded access programs - learn more about these programs and how to talk to your doctor.

Promoting walking to school: results of a quasi-experimental trial.

Science.gov (United States)

McKee, Rosie; Mutrie, Nanette; Crawford, Fiona; Green, Brian

2007-09-01

To assess the impact of a combined intervention on children's travel behaviour, stage of behavioural change and motivations for and barriers to actively commuting to school. A quasi-experimental trial involving pre- and post-intervention mapping of routes to school by active and inactive mode of travel and surveys of "stage of behaviour change" and motivations for and barriers to actively commuting to school. The intervention school participated in a school-based active travel project for one school term. Active travel was integrated into the curriculum and participants used interactive travel-planning resources at home. The control school participated in before and after measurements but did not receive the intervention. Two primary schools in Scotland with similar socioeconomic and demographic profiles. Two classes of primary 5 children and their families and teachers. Post intervention, the mean distance travelled to school by walking by intervention children increased significantly from baseline, from 198 to 772 m (389% increase). In the control group mean distance walked increased from 242 to 285 m (17% increase). The difference between the schools was significant (t (38) = -4.679, pschool by car by intervention children reduced significantly from baseline, from 2018 to 933 m (57.5% reduction). The mean distance travelled to school by car by control children increased from baseline, from 933 to 947 m (1.5% increase). The difference in the change between schools was significant (t (32) = 4.282, peffective in achieving an increase in the mean distance travelled by active mode and a reduction in the mean distance travelled by inactive mode on school journey.

Influence of experimental esophageal acidification on sleep bruxism: a randomized trial.

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Ohmure, H; Oikawa, K; Kanematsu, K; Saito, Y; Yamamoto, T; Nagahama, H; Tsubouchi, H; Miyawaki, S

2011-05-01

The aim of this cross-over, randomized, single-blinded trial was to examine whether intra-esophageal acidification induces sleep bruxism (SB). Polysomnography with electromyogram (EMG) of masseter muscle, audio-video recording, and esophageal pH monitoring were performed in a sleep laboratory. Twelve healthy adult males without SB participated. Intra-esophageal infusions of 5-mL acidic solution (0.1 N HCl) or saline were administered. The frequencies of EMG bursts, rhythmic masticatory muscle activity (RMMA) episodes, grinding noise, and the RMMA/microarousal ratio were significantly higher in the 20-minute period after acidic infusion than after saline infusion. RMMA episodes including SB were induced by esophageal acidification. This trial is registered with the UMIN Clinical Trials Registry, UMIN000002923. ASDA, American Sleep Disorders Association; EMG, electromyogram; GER, gastroesophageal reflux; LES, lower esophageal sphincter; NREM, non-rapid eye movement; REM, rapid eye movement; RMMA, rhythmic masticatory muscle activity; SB, sleep bruxism; SD, standard deviation; UES, upper esophageal sphincter.

N-doped hollow urchin-like anatase TiO2@C composite as a novel anode for Li-ion batteries

Science.gov (United States)

Xing, Yalan; Wang, Shengbin; Fang, Baizeng; Song, Ge; Wilkinson, David P.; Zhang, Shichao

2018-05-01

N-doped hollow urchin-like anatase TiO2 spheres (HUTSs) with carbon coating (HUTS@C) are prepared through a facile and scalable hydrothermal reaction followed by coating of polypyrrole and carbonization. The HUTS is composed of radially grown anatase nanorods and possesses an enhanced percentage of exposed {001} facets compared with P25 TiO2 nanoparticles. After the carbon coating, the HUTS@C retains the hollow nanostructure although covered with an N-doped carbon layer. As an anode for Li-ion batteries, the HUTS@C delivers a higher capacity of 165.1 mAh g-1 at 1C after 200 cycles and better rate capability (111.7 mAh g-1 at 10C) than the HUTS. Further electrochemical studies reveal that the HUTS@C has a better electrochemical reversibility, lower charge-transfer resistance, and higher Li-ion diffusion coefficient due to its unique nanosctructure including the hollow core, anatase phase of TiO2 microspheres with high exposed {001} facets and the N-doped carbon layer, which facilitates mass transport and enhances electrical conductivity.

Longitudinal evaluation of Ocimum and other plants effects on the feeding behavioral response of mosquitoes (Diptera: Culicidae in the field in Tanzania

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Tenu Filemoni

2008-10-01

Full Text Available Abstract Background The use of repellent materials from plants against nuisance insects is common with great potential to compliment existing malaria control programmes and this requires evaluation in the field. Ocimum plant species, Ocimum suave (Willd and O. kilimandscharicum (Guerke materials and their essential oils extracted by steam distillation were evaluated in the field and experimental huts for repellence, exophily and feeding inhibition effects against three mosquito species, Anopheles arabiensis (Patton, An. gambiae ss (Giles and Culex quinquefasciatus (Say. The protective effect of essential oils from Ocimum plants were compared with N, N-diethly-3- methylbenzamide (DEET, a standard synthetic repellent. Also, the protective effect of fumigation by burning of repellent plants; Ocimum suave, Ocimum kilimandscharicum, Azadirachta indica, Eucalyptus globules and Lantana camara were tested in experimental huts and selected local houses. Results In the field, protection by Ocimum plants from mosquito bites was high and there was small variation among different mosquito species. Protection efficiency was 93.4%, 91.98% and 89.75% for An. arabiensis while for Cx. quinquefaciatus it was 91.30%, 88.65% and 90.50% for DEET, Ocimum suave and O. kilimandscharicum respectively. In the experimental hut, deterrence induced by burning of Ocimum and other plants ranged from 73.1.0% to 81.9% for An. arabiensis and 56.5% to 67.8% for Cx. quinquefaciatus, while feeding inhibition was 61.1% to 100% for An. arabiensis and 50% to 100% for Cx. quinquefaciatus. Evaluations under field conditions confirmed high protective efficacy, enhanced feeding inhibition and house entry inhibition (Deterrence. Conclusion This study shows the potential of Ocimum suave and Ocimum kilimandscharicum crude extracts and whole plants of Ocimum suave, Ocimum kilimandscharicum, Azadirachta indica, Eucalyptus globules and Lantana camara for use in protecting against human biting

Which is preferable for orthostatic hypotension diagnosis in older adults: active standing test or head-up tilt table test?

Science.gov (United States)

Aydin, Ali Ekrem; Soysal, Pinar; Isik, Ahmet Turan

2017-01-01

Correct evaluation of orthostatic hypotension (OH) is crucial in geriatric practice, since OH is associated with mortality and morbidity. The study aimed to determine the most appropriate method for measuring blood pressure in transition from supine to upright position in order to diagnose OH in older adults. Active standing test (AST) and head-up tilt table (HUT) test as well as comprehensive geriatric assessment (CGA), including mini-mental state examination or the cognitive state test, mini-nutritional assessment, basic and instrumental activities of daily living, and Tinetti performance-oriented mobility assessment indexes, were performed in 290 geriatric patients. The prevalence of OH during HUT and AST was 19% and 37%, respectively. In patients with OH during HUT, the frequency of dementia and recurrent falls were higher ( P 0.05). Comparison of the groups according to CGA measurements revealed significant differences in terms of cognition, nutritional status, activities of daily life, and balance function in patients with OH only during HUT ( P 0.05). The sensitivity, specificity, positive predictive value, and negative predictive values of AST were 49.0%, 65.5%, 25.0%, and 84.6% respectively, according to HUT. The results suggest that orthostatic blood pressure changes determined by HUT might be of higher clinical significance than that by AST in older adults. It might be important that the evaluation of OH by HUT should be included in daily geriatric practice.

Gaseous emissions in pressurized fluidized-bed combustion: Analysis and summary of the pilot experiments

International Nuclear Information System (INIS)

Korpela, T.; Hippinen, I.

1995-01-01

The project connects the experimental data from the projects of pressurised fluidized-bed technology by HUT/EVO. The research objectives are behaviour of sulphur absorbents and reduction of sulphur dioxide emissions, reduction of nitrogen oxide emissions, release of vapour-phase alkali metals and carbon monoxide emissions. Optimal process conditions in relation to minimising the emissions are clarified

78 FR 25137 - Radio Experimentation and Market Trials-Streamlining Rules

Science.gov (United States)

2013-04-29

... rigor and diligence that the Commission demands under the program experimental license program. 38. The... rules to modernize the Experimental Radio Service (ERS). The rules adopted in the Report and Order... the Experimental Radio Service rules to provide additional flexibility to innovators, so that they can...

Spot profile analysis and lifetime mapping in ultrafast electron diffraction: Lattice excitation of self-organized Ge nanostructures on Si(001

Directory of Open Access Journals (Sweden)

T. Frigge

2015-05-01

Full Text Available Ultrafast high energy electron diffraction in reflection geometry is employed to study the structural dynamics of self-organized Germanium hut-, dome-, and relaxed clusters on Si(001 upon femtosecond laser excitation. Utilizing the difference in size and strain state the response of hut- and dome clusters can be distinguished by a transient spot profile analysis. Surface diffraction from {105}-type facets provide exclusive information on hut clusters. A pixel-by-pixel analysis of the dynamics of the entire diffraction pattern gives time constants of 40, 160, and 390 ps, which are assigned to the cooling time constants for hut-, dome-, and relaxed clusters.

Pentaquarks. An experimental overview

International Nuclear Information System (INIS)

Barna, D.

2005-01-01

Since the recent observation of a pentaquark (Θ + = qqqqq-bar) state (see Nakano et al. (LEPS Collaboration), Phys. Rev. Lett.91 (2003) 012002-1) several positive and negative experimental results have emerged. These results are overviewed, with a trial to find common features among them. (author)

Improving the precision of genotype selection in wheat performance trials

Directory of Open Access Journals (Sweden)

Giovani Benin

2013-12-01

Full Text Available The aim of this study was to verify whether using the Papadakis method improves model assumptions and experimental accuracy in field trials used to determine grain yield for wheat lineages indifferent Value for Cultivation and Use (VCU regions. Grain yield data from 572 field trials at 31 locations in the VCU Regions 1, 2, 3 and 4 in 2007-2011 were used. Each trial was run with and without the use of the Papadakis method. The Papadakis method improved the indices of experimental precision measures and reduced the number of experimental repetitions required to predict grain yield performance among the wheat genotypes. There were differences among the wheat adaptation regions in terms of the efficiency of the Papadakis method, the adjustment coefficient of the genotype averages and the increases in the selective accuracy of grain yield.

The mast on the house

DEFF Research Database (Denmark)

Landberg, L.

1997-01-01

An often encountered problem when preparing the basic input data for a wind atlas is the correction for the influence of the house or hut on which the mast - whose data forms the basis of this wind atlas - is placed. The paper will describe an experiment, where this problem has been addressed....... The knowledge gained will be used to give guide-lines as to the use of the WASP program to correct the observations. Should the house/hut simply be treated as an extension of the mast, should the house/hut be treated as a hill with speed-up effects, or should the house/hill be ignored completely? The paper...... will show that the house/hut should indeed be treated as a hill with speed-up effects. Placing meteorological masts on houses or huts is common practice in quite a few countries in the world. The problem is therefore one which most people involved in detailed wind resource assessment will face sooner...

The mast on the house

DEFF Research Database (Denmark)

Landberg, L.

2000-01-01

An often encountered problem when preparing the basic input data for a wind atlas study is the correction for the influence of the house or hut on which the mast—whose data form the basis of this wind atlas—is placed. The article will describe an experiment where this problem has been addressed....... The knowledge gained will be used to give guidelines as to the use of the WAsP program to correct the observations. Should the house/hut simply be treated as an extension of the mast, should the house/hut be treated as a hill with speed-up effects, or should the house/hill be ignored completely? The paper...... will show that the house/hut should indeed be treated as a hill with speed-up effects. Placing meteorological masts on houses or huts is common practice in quite a few countries in the world. The problem is therefore one which most people involved in detailed wind resource assessment will face sooner...

Nonconsensual clinical trials: a foreseeable risk of offshoring under global corporatism.

Science.gov (United States)

Spielman, Bethany

2015-03-01

This paper explores the connection of offshoring and outsourcing to nonconsensual global pharmaceutical trials in low-income countries. After discussing reasons why the topic of nonconsensual offshored clinical trials may be overlooked in bioethics literature, I suggest that when pharmaceutical corporations offshore clinical trials today, nonconsensual experiments are often foreseeable and not simply the result of aberrant ethical conduct by a few individuals. Offshoring of clinical trials is structured so that experiments can be presented as health care in a unique form of outsourcing from the host country to pharmaceutical corporations. Bioethicists' assessments of the risks and potential benefits of offshore corporate pharmaceutical trials should therefore systematically include not only the hoped for benefits and the risks of the experimental drug but also the risk that subjects will not have consented, as well as the broader international consequences of nonconsensual experimentation.

Reward-prospect interacts with trial-by-trial preparation for potential distraction.

Science.gov (United States)

Marini, Francesco; van den Berg, Berry; Woldorff, Marty G

2015-02-01

When attending for impending visual stimuli, cognitive systems prepare to identify relevant information while ignoring irrelevant, potentially distracting input. Recent work (Marini et al., 2013) showed that a supramodal distracter-filtering mechanism is invoked in blocked designs involving expectation of possible distracter stimuli, although this entails a cost ( distraction-filtering cost ) on speeded performance when distracters are expected but not presented. Here we used an arrow-flanker task to study whether an analogous cost, potentially reflecting the recruitment of a specific distraction-filtering mechanism, occurs dynamically when potential distraction is cued trial-to-trial ( cued distracter-expectation cost ). In order to promote the maximal utilization of cue information by participants, in some experimental conditions the cue also signaled the possibility of earning a monetary reward for fast and accurate performance. This design also allowed us to investigate the interplay between anticipation for distracters and anticipation of reward, which is known to engender attentional preparation. Only in reward contexts did participants show a cued distracter-expectation cost, which was larger with higher reward prospect and when anticipation for both distracters and reward were manipulated trial-to-trial. Thus, these results indicate that reward prospect interacts with the distracter expectation during trial-by-trial preparatory processes for potential distraction. These findings highlight how reward guides cue-driven attentional preparation.

Magnitude of effects in clinical trials published in high-impact general medical journals.

Science.gov (United States)

Siontis, Konstantinos C M; Evangelou, Evangelos; Ioannidis, John P A

2011-10-01

Prestigious journals select for publication studies that are considered most important and informative. We aimed to examine whether high-impact general (HIG) medical journals systematically demonstrate more favourable results for experimental interventions compared with the rest of the literature. We scrutinized systematic reviews of the Cochrane Database (Issue 4, 2009) and meta-analyses published in four general journals (2008-09). Eligible articles included ≥1 binary outcome meta-analysis(es) pertaining to effectiveness with ≥1 clinical trial(s) published in NEJM, JAMA or Lancet. Effect sizes in trials from NEJM, JAMA or Lancet were compared with those from other trials in the same meta-analyses by deriving summary relative odds ratios (sRORs). Additional analyses examined separately early- and late-published trials in HIG journals and journal-specific effects. A total of 79 meta-analyses including 1043 clinical trials were analysed. Trials in HIG journals had similar effects to trials in other journals, when there was large-scale evidence, but showed more favourable results for experimental interventions when they were small. When HIG trials had less than 40 events, the sROR was 1.64 [95% confidence interval (95% CI): 1.23-2.18). The difference was most prominent when small early trials published in HIG journals were compared with subsequent trials [sROR 2.68 (95% CI: 1.33-5.38)]. Late-published HIG trials showed no consistent inflation of effects. The patterns did not differ beyond chance between NEJM, JAMA or Lancet. Small trials published in the most prestigious journals show more favourable effects for experimental interventions, and this is most prominent for early-published trials in such journals. No effect inflation is seen for large trials.

An experimental trial exploring the impact of continuous transdermal alcohol monitoring upon alcohol consumption in a cohort of male students.

Science.gov (United States)

Neville, Fergus G; Williams, Damien J; Goodall, Christine A; Murer, Jeffrey S; Donnelly, Peter D

2013-01-01

To examine the impact of continuous transdermal alcohol monitoring upon alcohol consumption in male students at a Scottish university. Using a within-subject mixed-methods design, 60 male university students were randomly allocated into three experimental conditions using AUDIT score stratified sampling. Participants in Conditions A and B were asked not to consume alcohol for a 14-day period, with those in Condition A additionally being required to wear a continuous transdermal alcohol monitoring anklet. Condition C participants wore an anklet and were asked to continue consuming alcohol as normal. Alcohol consumption was measured through alcohol timeline follow-back, and using data collected from the anklets where available. Diaries and focus groups explored participants' experiences of the trial. Alcohol consumption during the 14-day trial decreased significantly for participants in Conditions A and B, but not in C. There was no significant relative difference in units of alcohol consumed between Conditions A and B, but significantly fewer participants in Condition A drank alcohol than in Condition B. Possible reasons for this difference identified from the focus groups and diaries included the anklet acting as a reminder of commitment to the study (and the agreement to sobriety), participants feeling under surveillance, and the use of the anklet as a tool to resist social pressure to consume alcohol. The study provided experience in using continuous transdermal alcohol monitors in an experimental context, and demonstrated ways in which the technology may be supportive in facilitating sobriety. Results from the study have been used to design a research project using continuous transdermal alcohol monitors with ex-offenders who recognise a link between their alcohol consumption and offending behaviour.

Closure Report for Corrective Action Unit 340: NTS Pesticide Release Sites Nevada Test Site, Nevada

Energy Technology Data Exchange (ETDEWEB)

C. M. Obi

2000-05-01

The purpose of this report is to provide documentation of the completed corrective action and to provide data confirming the corrective action. The corrective action was performed in accordance with the approved Corrective Action Plan (CAP) (U.S. Department of Energy [DOE], 1999) and consisted of clean closure by excavation and disposal. The Area 15 Quonset Hut 15-11 was formerly used for storage of farm supplies including pesticides, herbicides, and fertilizers. The Area 23 Quonset Hut 800 was formerly used to clean pesticide and herbicide equipment. Steam-cleaning rinsate and sink drainage occasionally overflowed a sump into adjoining drainage ditches. One ditch flows south and is referred to as the quonset hut ditch. The other ditch flows southeast and is referred to as the inner drainage ditch. The Area 23 Skid Huts were formerly used for storing and mixing pesticide and herbicide solutions. Excess solutions were released directly to the ground near the skid huts. The skid huts were moved to a nearby location prior to the site characterization performed in 1998 and reported in the Corrective Action Decision Document (CADD) (DOE, 1998). The vicinity and site plans of the Area 23 sites are shown in Figures 2 and 3, respectively.

Identifying the effective concentration for spatial repellency of the dengue vector Aedes aegypti.

Science.gov (United States)

Achee, Nicole; Masuoka, Penny; Smith, Philip; Martin, Nicholas; Chareonviryiphap, Theeraphap; Polsomboon, Suppaluck; Hendarto, Joko; Grieco, John

2012-12-28

Current efforts are underway to quantify the chemical concentration in a treated air space that elicits a spatial repellent (deterrent) response in a vector population. Such information will facilitate identifying the optimum active ingredient (AI) dosage and intervention coverage important for the development of spatial repellent tools--one of several novel strategies being evaluated for vector-borne disease control. This study reports initial findings from air sampling experiments conducted under field conditions to describe the relationship between air concentrations of repellent AIs and deterrent behavior in the dengue vector, Aedes aegypti. Air samples were taken inside and outdoors of experimental huts located in Pu Tuey Village, Kanchanaburi Province, Thailand in conjunction with mosquito behavioral evaluations. A mark-release-recapture study design using interception traps was used to measure deterrency of Ae. aegypti against 0.00625% metofluthrin coils and DDT-treated fabric (2g/m2) within separate experimental trials. Sentinel mosquito cohorts were positioned adjacent to air sampling locations to monitor knock down responses to AI within the treated air space. Air samples were analyzed using two techniques: the U.S. Environmental Protection Agency (USEPA) Compendium Method TO-10A and thermal desorption (TD). Both the USEPA TO-10A and TD air sampling methods were able to detect and quantify volatized AIs under field conditions. Air samples indicated concentrations of both repellent chemicals below thresholds required for toxic responses (mortality) in mosquitoes. These concentrations elicited up to a 58% and 70% reduction in Ae. aegypti entry (i.e., deterrency) into treated experimental huts using metofluthrin coils and DDT-treated fabric, respectively. Minimal knock down was observed in sentinel mosquito cohorts positioned adjacent to air sampling locations during both chemical evaluations. This study is the first to describe two air sampling

Identifying the effective concentration for spatial repellency of the dengue vector Aedes aegypti

Directory of Open Access Journals (Sweden)

Achee Nicole

2012-12-01

Full Text Available Abstract Background Current efforts are underway to quantify the chemical concentration in a treated air space that elicits a spatial repellent (deterrent response in a vector population. Such information will facilitate identifying the optimum active ingredient (AI dosage and intervention coverage important for the development of spatial repellent tools – one of several novel strategies being evaluated for vector-borne disease control. This study reports initial findings from air sampling experiments conducted under field conditions to describe the relationship between air concentrations of repellent AIs and deterrent behavior in the dengue vector, Aedes aegypti. Methods Air samples were taken inside and outdoors of experimental huts located in Pu Tuey Village, Kanchanaburi Province, Thailand in conjunction with mosquito behavioral evaluations. A mark-release-recapture study design using interception traps was used to measure deterrency of Ae. aegypti against 0.00625% metofluthrin coils and DDT-treated fabric (2g/m2 within separate experimental trials. Sentinel mosquito cohorts were positioned adjacent to air sampling locations to monitor knock down responses to AI within the treated air space. Air samples were analyzed using two techniques: the U.S. Environmental Protection Agency (USEPA Compendium Method TO-10A and thermal desorption (TD. Results Both the USEPA TO-10A and TD air sampling methods were able to detect and quantify volatized AIs under field conditions. Air samples indicated concentrations of both repellent chemicals below thresholds required for toxic responses (mortality in mosquitoes. These concentrations elicited up to a 58% and 70% reduction in Ae. aegypti entry (i.e., deterrency into treated experimental huts using metofluthrin coils and DDT-treated fabric, respectively. Minimal knock down was observed in sentinel mosquito cohorts positioned adjacent to air sampling locations during both chemical evaluations. Conclusions

Effect of Aedes aegypti exposure to spatial repellent chemicals on BG-Sentinel™ trap catches.

Science.gov (United States)

Salazar, Ferdinand V; Achee, Nicole L; Grieco, John P; Prabaripai, Atchariya; Ojo, Tolulope A; Eisen, Lars; Dureza, Christine; Polsomboon, Suppaluck; Chareonviriyaphap, Theeraphap

2013-05-20

An integrated approach to reduce densities of adult Aedes aegypti inside homes is currently being evaluated under experimentally controlled field conditions. The strategy combines a spatial repellent (SR) treatment (applied indoors) with the Biogents Sentinel™ (BGS) mosquito trap positioned in the outdoor environment. In essence, when combined, the goal is to create a push-pull mechanism that will reduce the probability of human-vector contact. The current study measured BGS recapture rates of Ae. aegypti test cohorts that were exposed to either SR or control (chemical-free) treatments within experimental huts. The objective was to define what, if any, negative impact SR may have on BGS trap efficacy (i.e., reduced BGS collection). Aedes aegypti females were exposed to SR compounds within experimental huts in the form of either treated fabric (DDT and transfluthrin) or mosquito coil (metofluthrin). Test cohorts were released within individual screen house cubicles, each containing 4 BGS traps, following SR exposure according to treatment. Two separate test cohorts were evaluated: (i) immediate release (IR) exposed from 06:00-12:00 hours and released at 12:00 hours and (ii) delayed release (DR) exposed from12:00-18:00 hours and released at 05:30 hours the following day. BGS recapture was monitored at 09:30, 13:30 and 15:30 hours and the cumulative recapture by time point quantified. Exposure of Ae. aegypti females to either DDT or metofluthrin did not significantly impact BGS capture as compared to cohorts of non-exposed females. This was true for both IR and DR exposure populations. IR cohorts exposed to transfluthrin resulted in significantly lower BGS recapture compared to matched controls but this effect was primarily due to high mosquito mortality during transfluthrin trials. Our data indicate no more than minor and short-lived impacts (i.e., reduced attraction) on BGS trap catches following exposure to the pyrethroid compounds transfluthrin and metofluthrin

Efficacy of Olyset® Plus, a new long-lasting insecticidal net incorporating permethrin and piperonyl-butoxide against multi-resistant malaria vectors [corrected].

Directory of Open Access Journals (Sweden)

Cédric Pennetier

Full Text Available Due to the rapid extension of pyrethroid resistance in malaria vectors worldwide, manufacturers are developing new vector control tools including insecticide mixtures containing at least two active ingredients with different mode of action as part of insecticide resistance management. Olyset® Plus is a new long-lasting insecticidal net (LLIN incorporating permethrin and a synergist, piperonyl butoxide (PBO, into its fibres in order to counteract metabolic-based pyrethroid resistance of mosquitoes. In this study, we evaluated the efficacy of Olyset® Plus both in laboratory and field against susceptible and multi-resistant malaria vectors and compared with Olyset Net, which is a permethrin incorporated into polyethylene net. In laboratory, Olyset® Plus performed better than Olyset® Net against susceptible Anopheles gambiae strain with a 2-day regeneration time owing to an improved permethrin bleeding rate with the new incorporation technology. It also performed better than Olyset® Net against multiple resistant populations of An. gambiae in experimental hut trials in West Africa. Moreover, the present study showed evidence for a benefit of incorporating a synergist, PBO, with a pyrethroid insecticide into mosquito netting. These results need to be further validated in a large-scale field trial to assess the durability and acceptability of this new tool for malaria vector control.

A precisão experimental relacionada ao uso de bordaduras nas extremidades das fileiras em ensaios de milho The experimental precision related by using border plants at the ends of rows in corn trials

Directory of Open Access Journals (Sweden)

Alberto Cargnelutti Filho

2003-08-01

Full Text Available Foram conduzidos quatro experimentos de competição de cultivares de milho, durante o ano agrícola de 2000/2001, e três no ano 2001/2002, na área experimental do Departamento de Fitotecnia da UFSM, Santa Maria, com o objetivo de verificar se o uso de bordadura nas extremidades das fileiras melhora a precisão experimental. Foi usado o delineamento em blocos ao acaso com três repetições, sendo os blocos espaçados entre si de um metro, e as parcelas constituídas por duas fileiras espaçadas de 0,8m com 5,0m de comprimento, com a área útil formada pelos quatro metros centrais. Para a variável rendimento de grãos de milho, procedeu-se a verificação das pressuposições do modelo, a análise da variância com teste F e a aplicação do teste Scott-Knott para as comparações entre as médias estimadas na área útil e na área total. A estatística diferença mínima significativa pelo teste de Tukey foi usada como principal indicador da precisão, cuja significância foi testada pelo teste F dos respectivos quadrados médios do erro. Todas as pressuposições do modelo matemático, nos sete experimentos, foram atendidas. Para o rendimento de grãos, o descarte dos resultados da bordadura nas extremidades das fileiras não altera a precisão experimental na comparação de cultivares.Seven experiments of corn cultivar competition were carried out to quantify the experimental precision improvement by evaluating border plants at the ends of rows of corn trials. The experiments were conducted during 2000 and 2001 grown seasons at the experimental area of the Fitotecnia Department, Federal University of Santa Maria, RS, Brazil. Each cultivar was replicated three times in plots of two rows of 5.0m separated by 0.80m following a randomized complete block design. The 0.5m of the ends of the same plot rows was considered as border plants and was separated evaluated. Data on grain yield of plot and total yield including border plants were used

Methods and design of a 10-week multi-component family meals intervention: a two group quasi-experimental effectiveness trial

Directory of Open Access Journals (Sweden)

Catherine Rogers

2017-01-01

Full Text Available Abstract Background Given the ongoing childhood obesity public health crisis and potential protective effect of family meals, there is need for additional family meals research, specifically experimental studies with expanded health outcomes that focus on the at-risk populations in highest need of intervention. Future research, specifically intervention work, would also benefit from an expansion of the target age range to include younger children, who are laying the foundation of their eating patterns and capable of participating in family meal preparations. The purpose of this paper is to address this research gap by presenting the objectives and research methods of a 10-week multi-component family meals intervention study aimed at eliciting positive changes in child diet and weight status. Methods This will be a group quasi-experimental trial with staggered cohort design. Data will be collected via direct measure and questionnaires at baseline, intervention completion (or waiting period for controls, and 10-weeks post-intervention. Setting will be faith-based community center. Participants will be 60 underserved families with at least 1, 4–10 year old child will be recruited and enrolled in the intervention (n = 30 or waitlist control group (n = 30. The intervention (Simple Suppers is a 10-week family meals program designed for underserved families from racial/ethnic diverse backgrounds. The 10, 90-min program lessons will be delivered weekly over the dinner hour. Session components include: a interactive group discussion of strategies to overcome family meal barriers, plus weekly goal setting for caregivers; b engagement in age-appropriate food preparation activities for children; and c group family meal for caregivers and children. Main outcome measures are change in: child diet quality; child standardized body mass index; and frequency of family meals. Regression models will be used to compare response variables results of

Spatiotemporal dynamics of random stimuli account for trial-to-trial variability in perceptual decision making

Science.gov (United States)

Park, Hame; Lueckmann, Jan-Matthis; von Kriegstein, Katharina; Bitzer, Sebastian; Kiebel, Stefan J.

2016-01-01

Decisions in everyday life are prone to error. Standard models typically assume that errors during perceptual decisions are due to noise. However, it is unclear how noise in the sensory input affects the decision. Here we show that there are experimental tasks for which one can analyse the exact spatio-temporal details of a dynamic sensory noise and better understand variability in human perceptual decisions. Using a new experimental visual tracking task and a novel Bayesian decision making model, we found that the spatio-temporal noise fluctuations in the input of single trials explain a significant part of the observed responses. Our results show that modelling the precise internal representations of human participants helps predict when perceptual decisions go wrong. Furthermore, by modelling precisely the stimuli at the single-trial level, we were able to identify the underlying mechanism of perceptual decision making in more detail than standard models. PMID:26752272

MIDAS: a practical Bayesian design for platform trials with molecularly targeted agents.

Science.gov (United States)

Yuan, Ying; Guo, Beibei; Munsell, Mark; Lu, Karen; Jazaeri, Amir

2016-09-30

Recent success of immunotherapy and other targeted therapies in cancer treatment has led to an unprecedented surge in the number of novel therapeutic agents that need to be evaluated in clinical trials. Traditional phase II clinical trial designs were developed for evaluating one candidate treatment at a time and thus not efficient for this task. We propose a Bayesian phase II platform design, the multi-candidate iterative design with adaptive selection (MIDAS), which allows investigators to continuously screen a large number of candidate agents in an efficient and seamless fashion. MIDAS consists of one control arm, which contains a standard therapy as the control, and several experimental arms, which contain the experimental agents. Patients are adaptively randomized to the control and experimental agents based on their estimated efficacy. During the trial, we adaptively drop inefficacious or overly toxic agents and 'graduate' the promising agents from the trial to the next stage of development. Whenever an experimental agent graduates or is dropped, the corresponding arm opens immediately for testing the next available new agent. Simulation studies show that MIDAS substantially outperforms the conventional approach. The proposed design yields a significantly higher probability for identifying the promising agents and dropping the futile agents. In addition, MIDAS requires only one master protocol, which streamlines trial conduct and substantially decreases the overhead burden. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Field Monitoring of Experimental Hot Mix Asphalt Projects Placed in Massachusetts

Science.gov (United States)

2017-06-30

Since 2000, Massachusetts has been involved with numerous field trials of experimental hot mix asphalt mixtures. These experimental mixtures included several pilot projects using the Superpave mixture design methodology, utilization of warm mix aspha...

Experimental gingivitis, bacteremia and systemic biomarkers: a randomized clinical trial.

Science.gov (United States)

Kinane, D F; Zhang, P; Benakanakere, M; Singleton, J; Biesbrock, A; Nonnenmacher, C; He, T

2015-12-01

Bacteremia and systemic inflammatory markers are associated with periodontal and systemic diseases and may be linking mechanisms between these conditions. We hypothesized that in the development of gingival inflammation, systemic markers of inflammation and bacteremia would increase. To study the effect of bacteremia on systemic inflammatory markers, we recruited 80 subjects to participate in an experimental gingivitis study. Subjects were stratified based on gender, smoking and the number of bleeding sites and then randomized to one of two groups: control group (n = 40) or experimental gingivitis group (n = 40). Subjects in the control group conducted an oral hygiene regimen: brushing twice daily with a regular sodium fluoride cavity protection dentifrice and a standard manual toothbrush, flossing twice daily, and mouth rinsing with an anti-cavity fluoride rinse once daily. The experimental group stopped brushing and flossing, and used only the fluoride anti-cavity mouth rinse for 21 d. Seventy-nine of 80 subjects were evaluable. One subject in the control group was excluded from the results due to antibiotic use during the study. Our data showed the experimental gingivitis group exhibited a significant (p gingival inflammatory indices relative to baseline and the control group but a decrease in bacteremia and soluble intercellular adhesion molecule-1 levels vs. baseline. Bacteremia was negatively correlated with gingival inflammatory indices and soluble intercellular adhesion molecule-1 levels in the experimental gingivitis group, thus negating our hypothesis. We conclude that there are marked differences in systemic cytokine levels over the course of short-term experimentally induced gingivitis and further conclude that a long-term periodontitis study must be considered to address mechanisms whereby oral diseases may affect systemic diseases. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Tilt table testing in patients with suspected epilepsy1

DEFF Research Database (Denmark)

Edfors, R.; Erdal, J.; Rogvi-Hansen, B.

2008-01-01

BACKGROUND: Approximately 20-30% of patients with epilepsy are misdiagnosed and syncope often seems to be the mistaken cause. We re-evaluated patients referred to an epilepsy clinic where suspicion of neurally mediated (reflex) syncope were raised using tilt table testing (HUT). METHODS: HUT...... laboratory results and medical records of 120 consecutive patients were reviewed retrospectively over a period of 27 months. RESULTS: HUT was positive in 59 (49%) patients. Seventeen of 38 (45%) patients previously diagnosed with epilepsy and taking antiepileptic drugs were found to be misdiagnosed. Four...... of 21 patients with epilepsy (19%) had dual diagnoses of reflex syncope and epilepsy. CONCLUSION: HUT is an informative investigation when suspicions of reflex syncope are raised in patients referred to an epilepsy clinic. Reflex syncope is an important and common differential diagnosis of epilepsy...

Design of Phase II Non-inferiority Trials.

Science.gov (United States)

Jung, Sin-Ho

2017-09-01

With the development of inexpensive treatment regimens and less invasive surgical procedures, we are confronted with non-inferiority study objectives. A non-inferiority phase III trial requires a roughly four times larger sample size than that of a similar standard superiority trial. Because of the large required sample size, we often face feasibility issues to open a non-inferiority trial. Furthermore, due to lack of phase II non-inferiority trial design methods, we do not have an opportunity to investigate the efficacy of the experimental therapy through a phase II trial. As a result, we often fail to open a non-inferiority phase III trial and a large number of non-inferiority clinical questions still remain unanswered. In this paper, we want to develop some designs for non-inferiority randomized phase II trials with feasible sample sizes. At first, we review a design method for non-inferiority phase III trials. Subsequently, we propose three different designs for non-inferiority phase II trials that can be used under different settings. Each method is demonstrated with examples. Each of the proposed design methods is shown to require a reasonable sample size for non-inferiority phase II trials. The three different non-inferiority phase II trial designs are used under different settings, but require similar sample sizes that are typical for phase II trials.

Should desperate volunteers be included in randomised controlled trials?

Science.gov (United States)

Allmark, P; Mason, S

2006-09-01

Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguments that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire.

Contact irritant responses of Aedes aegypti Using sublethal concentration and focal application of pyrethroid chemicals.

Directory of Open Access Journals (Sweden)

Hortance Manda

Full Text Available BACKGROUND: Previous studies have demonstrated contact irritant and spatial repellent behaviors in Aedes aegypti following exposure to sublethal concentrations of chemicals. These sublethal actions are currently being evaluated in the development of a push-pull strategy for Ae. aegypti control. This study reports on mosquito escape responses after exposure to candidate chemicals for a contact irritant focused push-pull strategy using varying concentrations and focal application. METHODS: Contact irritancy (escape behavior, knockdown and 24 hour mortality rates were quantified in populations of female Ae. aegypti under laboratory conditions and validated in the field (Thailand and Peru using experimental huts. Evaluations were conducted using varying concentrations and treatment surface area coverage (SAC of three pyrethroid insecticides: alphacypermethrin, lambacyhalothrin and deltamethrin. RESULTS: Under laboratory conditions, exposure of Ae. aegypti to alphacypermethrin using the standard field application rate (FAR resulted in escape responses at 25% and 50% SAC that were comparable with escape responses at 100% SAC. Significant escape responses were also observed at <100% SAC using ½FAR of all test compounds. In most trials, KD and 24 hour mortality rates were higher in mosquitoes that did not escape than in those that escaped. In Thailand, field validation studies indicated an early time of exit (by four hours and 40% increase in escape using ½FAR of alphacypermethrin at 75% SAC compared to a matched chemical-free control. In Peru, however, the maximum increase in Ae. aegypti escape from alphacypermethrin-treated huts was 11%. CONCLUSIONS/SIGNIFICANCE: Results presented here suggest a potential role for sublethal and focal application of contact irritant chemicals in an Ae. aegypti push-pull strategy to reduce human-vector contact inside treated homes. However, the impact of an increase in escape response on dengue virus transmission is

Effect of root planing on surface topography: an in-vivo randomized experimental trial.

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Rosales-Leal, J I; Flores, A B; Contreras, T; Bravo, M; Cabrerizo-Vílchez, M A; Mesa, F

2015-04-01

The root surface topography exerts a major influence on clinical attachment and bacterial recolonization after root planing. In-vitro topographic studies have yielded variable results, and clinical studies are necessary to compare root surface topography after planing with current ultrasonic devices and with traditional manual instrumentation. The aim of this study was to compare the topography of untreated single-rooted teeth planed in vivo with a curette, a piezoelectric ultrasonic (PU) scraper or a vertically oscillating ultrasonic (VOU) scraper. In a randomized experimental trial of 19 patients, 44 single-rooted teeth were randomly assigned to one of four groups for: no treatment; manual root planing with a curette; root planing with a PU scraper; or root planing with a VOU scraper. Post-treatment, the teeth were extracted and their topography was analyzed in 124 observations with white-light confocal microscopy, measuring the roughness parameters arithmetic average height, root-mean-square roughness, maximum height of peaks, maximum depth of valleys, absolute height, skewness and kurtosis. The roughness values arithmetic average height and root-mean-square roughness were similar after each treatment and lower than after no treatment ( p  0.05). Both ultrasonic devices reduce the roughness, producing a similar topography to that observed after manual instrumentation with a curette, to which they appear to represent a valid alternative. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Experimenter gender and replicability in science.

Science.gov (United States)

Chapman, Colin D; Benedict, Christian; Schiöth, Helgi B

2018-01-01

There is a replication crisis spreading through the annals of scientific inquiry. Although some work has been carried out to uncover the roots of this issue, much remains unanswered. With this in mind, this paper investigates how the gender of the experimenter may affect experimental findings. Clinical trials are regularly carried out without any report of the experimenter's gender and with dubious knowledge of its influence. Consequently, significant biases caused by the experimenter's gender may lead researchers to conclude that therapeutics or other interventions are either overtreating or undertreating a variety of conditions. Bearing this in mind, this policy paper emphasizes the importance of reporting and controlling for experimenter gender in future research. As backdrop, it explores what we know about the role of experimenter gender in influencing laboratory results, suggests possible mechanisms, and suggests future areas of inquiry.

A research-based strategy for managing housing adaptations: study protocol for a quasi-experimental trial.

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Ekstam, Lisa; Carlsson, Gunilla; Chiatti, Carlos; Nilsson, Maria H; Malmgren Fänge, Agneta

2014-11-29

The primary aim of this paper is to describe the design of a project evaluating the effects of using a research-based strategy for managing housing adaptations (HAs). The evaluation targets clients' perspectives in terms of activity, participation, usability, fear of falling, fall incidence, use of mobility devices, and health-related quality of life, and determines the societal effects of HAs in terms of costs. Additional aims of the project are to explore and describe this strategy in relation to experiences and expectations (a) among clients and cohabitants and (b) occupational therapists in ordinary practice. This study is a quasi-experimental trial applying a multiphase design, combining quantitative and qualitative data. At the experimental sites, the occupational therapists (OTs) apply the intervention, i.e. a standardized research-based strategy for HA case management. At the control site, the occupational therapists are following their regular routine in relation to HA. Three municipalities in south Sweden will be included based on their population, their geographical dispersion, and their similar organizational structures for HA administration. Identical data on outcomes is being collected at all the sites at the same four time points: before the HA and then 3, 6, and 12 months after the HA. The data-collection methods are semi-structured qualitative interviews, observations, clinical assessments, and certificates related to each client's HA. The intervention in this study has been developed and tested through many years of research and in collaboration with practitioners. This process includes methodological development and testing research aimed at identifying the most important outcomes and research targeting current HA case-management procedures in Swedish municipalities. When the study is completed, the results will be used for further optimization of the practice strategy for HA, in close collaboration with the data-collecting OTs. No: NCT01960582.

A Coorientational Analysis of Trial Lawyer and News Reporter Relationships.

Science.gov (United States)

Lipschultz, Jeremy Harris

A study considered the relationships of trial lawyers and news reporters, using the coorientation measurement model and Q-methodology, and adapting an analysis of variance experimental design. Sixty statements were constructed and administered to 24 subjects (12 trial lawyers and 12 news reporters) in two large midwestern cities. It was found…

Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual.

Science.gov (United States)

Tang, Chad; Hess, Kenneth R; Sanders, Dwana; Davis, Suzanne E; Buzdar, Aman U; Kurzrock, Razelle; Lee, J Jack; Meric-Bernstam, Funda; Hong, David S

2017-03-15

Purpose: Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center (Houston, TX) and analyzed their effects on the trial activation timeline and enrolment. Experimental Design: Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database, we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results: We identified three facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship [industry (133 ICT and 133 non-ICT trials) or institutional (68 ICT and 68 non-ICT trials)]. ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrolment (median difference of 0.3 months for industry vs. 1.2 months for institutional; all matched P infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual. Clin Cancer Res; 23(6); 1407-13. ©2016 AACR . ©2016 American Association for Cancer Research.

Landscape and Residential Variables Associated with Plague-Endemic Villages in the West Nile Region of Uganda

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MacMillan, Katherine; Enscore, Russell E.; Ogen-Odoi, Asaph; Borchert, Jeff N.; Babi, Nackson; Amatre, Gerald; Atiku, Linda A.; Mead, Paul S.; Gage, Kenneth L.; Eisen, Rebecca J.

2011-01-01

Plague, caused by the bacteria Yersinia pestis, is a severe, often fatal disease. This study focuses on the plague-endemic West Nile region of Uganda, where limited information is available regarding environmental and behavioral risk factors associated with plague infection. We conducted observational surveys of 10 randomly selected huts within historically classified case and control villages (four each) two times during the dry season of 2006 (N = 78 case huts and N = 80 control huts), which immediately preceded a large plague outbreak. By coupling a previously published landscape-level statistical model of plague risk with this observational survey, we were able to identify potential residence-based risk factors for plague associated with huts within historic case or control villages (e.g., distance to neighboring homestead and presence of pigs near the home) and huts within areas previously predicted as elevated risk or low risk (e.g., corn and other annual crops grown near the home, water storage in the home, and processed commercial foods stored in the home). The identified variables are consistent with current ecologic theories on plague transmission dynamics. This preliminary study serves as a foundation for future case control studies in the area. PMID:21363983

Differential effects of lower body negative pressure and upright tilt on splanchnic blood volume

Science.gov (United States)

Taneja, Indu; Moran, Christopher; Medow, Marvin S.; Glover, June L.; Montgomery, Leslie D.; Stewart, Julian M.

2015-01-01

Upright posture and lower body negative pressure (LBNP) both induce reductions in central blood volume. However, regional circulatory responses to postural changes and LBNP may differ. Therefore, we studied regional blood flow and blood volume changes in 10 healthy subjects undergoing graded lower-body negative pressure (−10 to −50 mmHg) and 8 subjects undergoing incremental head-up tilt (HUT; 20°, 40°, and 70°) on separate days. We continuously measured blood pressure (BP), heart rate, and regional blood volumes and blood flows in the thoracic, splanchnic, pelvic, and leg segments by impedance plethysmography and calculated regional arterial resistances. Neither LBNP nor HUT altered systolic BP, whereas pulse pressure decreased significantly. Blood flow decreased in all segments, whereas peripheral resistances uniformly and significantly increased with both HUT and LBNP. Thoracic volume decreased while pelvic and leg volumes increased with HUT and LBNP. However, splanchnic volume changes were directionally opposite with stepwise decreases in splanchnic volume with LBNP and stepwise increases in splanchnic volume during HUT. Splanchnic emptying in LBNP models regional vascular changes during hemorrhage. Splanchnic filling may limit the ability of the splanchnic bed to respond to thoracic hypovolemia during upright posture. PMID:17085534

Citicoline for ischemic stroke: ICTUS trial

Directory of Open Access Journals (Sweden)

Vladimir Anatolyevich Parfenov

2012-01-01

Full Text Available The paper gives data available in the literature on the use of citicoline in an experimental model of ischemic stroke (IS and in randomized multicenter placebo-controlled trials. It analyzes the results of the ICTUS trial in which 2298 patients with IS who received randomly citicoline or placebo for 24 hours after the onset of symptoms (I000 mg intravenously every I2 hours during the first 3 days, then orally as one 500-mg tablet every 12 hours during 6 weeks. The results of the trial confirmed the safety of citicoline used in IS, but failed to show its significant advantage over placebo in reducing the degree of disability (global improvement 90 days later. However, to pool the results of the ICTUS trial with those of other randomized multicenter placebo-controlled studies demonstrates a significant decrease in the degree of disability in IS patients treated with citicoline.

Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

Directory of Open Access Journals (Sweden)

Paul P Christopher

Full Text Available Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials.This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50, and willingness to participate in the clinical trial.154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female; 74 (48.1% had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004 in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017. Willingness to participate in the hypothetical trial was not significantly different (p = 0.603 between intervention (52.1%, 95% CI [40.2% to 62.4%] and control (56.3%, 95% CI [45.3% to 66.6%] groups.An enhanced educational intervention augmenting

Single-trial regression elucidates the role of prefrontal theta oscillations in response conflict

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Michael X Cohen

2011-02-01

Full Text Available In most cognitive neuroscience experiments there are many behavioral and experimental dynamics, and many indices of brain activity, that vary from trial to trial. For example, in studies of response conflict, conflict is usually treated as a binary variable (i.e., response conflict exists or does not in any given trial, whereas some evidence and intuition suggests that conflict may vary in intensity from trial to trial. Here we demonstrate that single-trial multiple regression of time-frequency electrophysiological activity reveals neural mechanisms of cognitive control that are not apparent in cross-trial averages. We also introduce a novel extension to oscillation phase coherence and synchronization analyses, based on weighted phase modulation, that has advantages over standard coherence measures in terms of linking electrophysiological dynamics to trial-varying behavior and experimental variables. After replicating previous response conflict findings using trial-averaged data, we extend these findings using single trial analytic methods to provide novel evidence for the role of medial frontal-lateral prefrontal theta-band synchronization in conflict-induced response time dynamics, including a role for lateral prefrontal theta-band activity in biasing response times according to perceptual conflict. Given that these methods shed new light on the prefrontal mechanisms of response conflict, they are also likely to be useful for investigating other neurocognitive processes.

Fluid Redistribution and Heart Rate in Humans During Whole-Body Tilting, G(z) Centrifugation, and Lower Body Negative Pressure

Science.gov (United States)

Watenpaugh, D. E.; Breit, G. A.; Ballard, R. E.; Murthy, G.; Hargens, A. R.

1994-01-01

Gravity creates blood pressure gradients which redistribute body fluids towards the feet. Positive G(z) centrifugation and lower body negative pressure (LBNP) have been proposed to simulate these and other effects of gravity during long-term existence in microgravity. We hypothesized that the magnitude of upper-to-lower body fluid redistribution would increase according to the following order: short-arm centrifugation (SAC), long-arm centrifugation (LAC), head-up tilt (HUT), and LBNP. To test this hypothesis, we employed strain gauge plethysmography of the neck, thigh and calf during HUT and supine SAC and LAC up to lG(z) at the feet, and during supine LBNP to 100 mm Hg. Supine 100 mm Hg LBNP generates footward force and produces transmural blood pressures in the foot approximately equal to 1 G(z) (90 deg) HUT. Heart rate was measured via cardiotachometry. Control measurements were made while supine. SAC and LAC elicited similar increases in thigh volume at 1 G(z) (2.3 +/- 0.4 and 2.1 +/- 0.1%, respectively; mean +/- se, n greater than or equal to 7). At 100 mm Hg LBNP, thigh volume increased (3.4 +/- 0.3%) significantly more than during l G(z) centrifugation (p less than 0.05). Surprisingly, due to a paradoxical 0.6% reduction of thigh volume between 0.8 and 1.0 G(z) HUT, thigh volume was increased only 0.6 +/- 0.3% at 1 G(z) HUT. The calf demonstrated similar, although less definitive, responses to the various gravitational stimuli. Neck volume tended to decrease less during HUT than during the other stimuli. Heart rate increased similarly during HUT (18 +/- 2 beats/min) and LAC (12 +/- 2 beats/min), and exhibited still greater elevation during LBNP (29 +/- 4 beats/min), yet did not increase during SAC. These results suggest upright posture activates mechanisms that counteract footward fluid redistribution which are not activated during supine applications of simulated gravity. LAC more closely approximated effects of normal gravity (HUT) than LBNP. Therefore

PR Crisis Melalui Media Sosial

Directory of Open Access Journals (Sweden)

Gladys Carlina

2017-07-01

Full Text Available The background of this research is communication, new media, PR and PR Crisis. Fourth of this background has a close relationship, starting from communication, human in everyday life would require communication to receive and convey information, human can not be released from human life. The advancement of the times and the development of technology, causing people to communicate easily and the development of this era caused a new challenge for the PR and PR Crisis of a company, they should be able to maintain a positive image of the company in the minds of people. In this study using descriptive qualitative methodology, it contains many writings and drawings compared to the numbers. The purpose of this research is to know the strategy used by Pizza Hut in dealing with the issue of expired food. Penelitin results, social media is very positive impact on Pizza Hut in the recovery of food issues expired. The strategy used by the Pizza Hut Crisis PR is to utilize social media. Visible from the issue of expired food that disappeared in public and Pizza Hut restaurant until now crowded visited. Latar belakang dari penelitian ini yaitu komunikasi, media baru, PR dan PR Krisis. Keempat dari latar belakang ini mempunyai hubungan yang erat, dimulai dari komunikasi, manusia di dalam kehidupan sehari-hari tentunya memerlukan komunikasi untuk menerima dan menyampaikan informasi, manusia tidak bisa dilepaskan dari kehidupan manusia. Majunya perkembangan zaman dan perkembangan teknologi, menyebabkan manusia melakukan komunikasi dengan mudah dan perkembangan zaman ini menyebabkan adanya tantangan baru bagi para PR dan PR Krisis sebuah perusahaan, mereka harus bisa mempertahankan citra positif perusahaan di benak masyarakat. Dalam penelitian ini menggunakan metodologi kualitatif deksriptif, memuat banyak tulisan dan gambar dibandingkan angka-angka. Tujuan dari penelitian ini untuk mengetahui strategi yang digunakan oleh Pizza Hut dalam menangani isu makanan

Results from an experimental trial at a Head Start center to evaluate two meal service approaches to increase fruit and vegetable intake of preschool aged children

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Harnack Lisa J

2012-04-01

Full Text Available Abstract Background Strategies to increase fruit and vegetable consumption of preschool aged children are needed. Objectives Evaluate the independent effects of the following meal service strategies on intake of fruits and vegetables of preschool children: 1. Serving fruits and vegetables in advance of other menu items as part of traditional family style meal service; and 2. Serving meals portioned and plated by providers. Methods Fifty-three preschool aged children completed a randomized crossover experiment conducted at a Head Start center in Minneapolis, MN. Over a six week trial period each of the experimental meal service strategies (serving fruits and vegetable first and serving meals portioned by providers was implemented during lunch service for two one-week periods. Two one-week control periods (traditional family style meal service with all menu items served at once were also included over the six week trial period. Childrens lunch intake was observed as a measure of food and nutrient intake during each experimental condition. Results Fruit intake was significantly higher (p Conclusions Serving fruits in advance of other meal items may be a low cost easy to implement strategy for increasing fruit intake in young children. However, serving vegetables first does not appear to increase vegetable intake. Results provide support for current recommendations for traditional family style meal service in preschool settings.

Effect of altered arterial perfusion pressure on vascular conductance and muscle blood flow dynamic response during exercise in humans.

Science.gov (United States)

Villar, Rodrigo; Hughson, Richard L

2013-03-01

Changes in vascular conductance (VC) are required to counter changes in muscle perfusion pressure (MPP) to maintain muscle blood flow (MBF) during exercise. We investigated the recruitment of VC as a function of peak VC measured in three body positions at two different work rates to test the hypothesis that adaptations in VC compensated changes in MPP at low-power output (LPO), but not at high-power output (HPO). Eleven healthy volunteers exercised at LPO and HPO (repeated plantar flexion contractions at 20-30% maximal voluntary contraction, respectively) in horizontal (HOR), 35° head-down tilt (HDT), and 45° head-up tilt (HUT). Muscle blood flow velocity and popliteal diameter were measured by ultrasound to determine MBF, and VC was estimated by dividing MBF flow by MPP. Peak VC was unaffected by body position. The rates of increase in MBF and VC were significantly faster in HUT and slower in HDT than HOR, and rates were faster in LPO than HPO. During LPO exercise, the increase in, and steady-state values of, MBF were less for HUT and HDT than HOR; the increase in VC was less in HUT than HOR and HDT. During HPO exercise, MBF in the HDT was reduced compared with HOR and HUT, even though VC reached 92% VC peak, which was greater than HOR, which was, in turn, greater than HUT. Reduced MBF during HPO HDT exercise had the functional consequence of a significant increase in muscle electromyographic index, revealing the effects of MPP on O2 delivery during exercise.

The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials

DEFF Research Database (Denmark)

Bello, Segun; Wei, Maoling; Hilden, Jørgen

2016-01-01

to systematically identify and analyse studies of matching quality in drug trials. Our primary objective was to assess the proportion of studies that concluded that the matching was inadequate; our secondary objective was to describe mechanisms for inadequate matching. Methods: Systematic review. We searched Pub...... published before 1977. The studies differed considerably with regard to design, methodology and analysis. Sixteen of the 36 studies (44 %) concluded inadequate matching. When we adapted high or low thresholds for inadequate matching, the number of trials with inadequate matching was reduced to 12 (33...

Experimental knee joint pain during strength training and muscle strength gain in healthy subjects: a randomized controlled trial.

Science.gov (United States)

Sørensen, T J; Langberg, H; Hodges, P W; Bliddal, H; Henriksen, M

2012-01-01

Knee joint pain and reduced quadriceps strength are cardinal symptoms in many knee pathologies. In people with painful knee pathologies, quadriceps exercise reduces pain, improves physical function, and increases muscle strength. A general assumption is that pain compromises muscle function and thus may prevent effective rehabilitation. This study evaluated the effects of experimental knee joint pain during quadriceps strength training on muscle strength gain in healthy individuals. Twenty-seven healthy untrained volunteers participated in a randomized controlled trial of quadriceps strengthening (3 times per week for 8 weeks). Participants were randomized to perform resistance training either during pain induced by injections of painful hypertonic saline (pain group, n = 13) or during a nonpainful control condition with injection of isotonic saline (control group, n = 14) into the infrapatellar fat pad. The primary outcome measure was change in maximal isokinetic muscle strength in knee extension/flexion (60, 120, and 180 degrees/second). The group who exercised with pain had a significantly larger improvement in isokinetic muscle strength at all angular velocities of knee extension compared to the control group. In knee flexion there were improvements in isokinetic muscle strength in both groups with no between-group differences. Experimental knee joint pain improved the training-induced gain in muscle strength following 8 weeks of quadriceps training. It remains to be studied whether knee joint pain has a positive effect on strength gain in patients with knee pathology. Copyright © 2012 by the American College of Rheumatology.

Counterbalancing for Serial Order Carryover Effects in Experimental Condition Orders

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Brooks, Joseph L.

2012-01-01

Reactions of neural, psychological, and social systems are rarely, if ever, independent of previous inputs and states. The potential for serial order carryover effects from one condition to the next in a sequence of experimental trials makes counterbalancing of condition order an essential part of experimental design. Here, a method is proposed…

77 FR 40322 - Oral Rabies Vaccine Trial; Availability of an Environmental Assessment

Science.gov (United States)

2012-07-09

...] Oral Rabies Vaccine Trial; Availability of an Environmental Assessment AGENCY: Animal and Plant Health... assessment relative to an oral rabies vaccination field trial in New Hampshire, New York, Ohio, Vermont, and West Virginia. The environmental assessment analyzes the use of an experimental rabies vaccine in field...

Informed consent in experimentation involving mentally impaired persons: ethical issues

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Carlo Petrini

2010-12-01

Full Text Available The problem of experimentation involving subjects whose mental condition prevents them from understanding information and providing proper informed consent has been addressed in various codes, declarations, conventions, treaties and regulations adopted by national, international and supranational institutions and authorities. This article summarizes the basic ethical criteria these documents provide and stresses the historical development from the nearly total exclusion of incapacitated subjects, established in the mid-twentieth century, to their contemporary inclusion in clinical trials on certain ethical conditions. The problem of proxy consent by legal representatives for participation in clinical trials is addressed particularly in reference to current Italian regulations. Exceptions to human experimentation requirements in emergency situations are also briefly discussed.

The Moral Trial: On Ethics and Economics

NARCIS (Netherlands)

A. Lanteri (Alessandro)

2008-01-01

textabstractThis dissertation investigates the experimental evidence exposing how economists’ behaviour differs from that of non-economists, in that economists display more self-interested conduct. A veritable Moral Trial has stemmed from that evidence, in which it is argued that economists are

Optimum level of salt in French-type bread. Influence of income status, salt level in daily bread consumption, and test location.

Science.gov (United States)

Sosa, M; Flores, A; Hough, G; Apro, N; Ferreyra, V; Orbea, M M

2008-10-01

The objectives of the present study were to measure the ideal salt concentration in French-type bread among Argentine consumers in a home-usage-test (HUT) considering income status and salt content of daily bread consumption as covariables, and to compare the ideal salt concentrations measured in a HUT and a central-location test (CLT). For the HUT, 420 consumers each received a sample of bread with a single salt concentration, and for the CLT, 100 consumers each received 7 samples with different salt concentrations. For each sample, consumers responded if they found the bread "not-salty-enough,"okay," or "too-salty." Neither income level nor salt content of daily bread influenced probability of rejection. The optimum sodium concentrations (milligrams per 100 g of bread dry basis) +/- 95% confidence limits for the HUT and CLT were 980 +/- 74 and 1157 +/- 87, respectively. These values are substantially higher than 628, the mean sodium content of the bread sampled from the bakery shops where consumers bought their daily bread.

Early history of soil contamination with fission products

International Nuclear Information System (INIS)

Nagel, E.

1985-01-01

Underneath a balloon and instrument hut demolished today and on the natural pasture next to it, a series of 2 to 4-layer soil samples was carried out to determine the contents in Cs-137 and Sr-90. The results showed a sudded decrease of the Cs concentration behind the walls of the hut, but no further decrease towards the centre of the hut. As expected, the decrease of Sr-90 concentration was slower, both in a horizontal line and in the depth. The results reveal that the soil underneath the hut has not received further fission products since it was built in 1956 from depositions of later nuclear weapon tests. Furthermore, the radionuclides were not transported much further into lower strata so that by taking into consideration of the half-life of the two nuclides their concentration in the soil can be traced back to the year 1956 for comparison with the results measured at the time. (orig./HP) [de

Systemic steroid reduces long-term hearing loss in experimental pneumococcal meningitis

DEFF Research Database (Denmark)

Worsøe, Lise Lotte; Brandt, C.T.; Lund, S.P.

2010-01-01

Sensorineural hearing loss is a common complication of pneumococcal meningitis. Treatment with corticosteroids reduces inflammatory response and may thereby reduce hearing loss. However, both experimental studies and clinical trials investigating the effect of corticosteroids on hearing loss have...... generated conflicting results. The objective of the present study was to determine whether systemic steroid treatment had an effect on hearing loss and cochlear damage in a rat model of pneumococcal meningitis.......Sensorineural hearing loss is a common complication of pneumococcal meningitis. Treatment with corticosteroids reduces inflammatory response and may thereby reduce hearing loss. However, both experimental studies and clinical trials investigating the effect of corticosteroids on hearing loss have...

A studentized permutation test for three-arm trials in the 'gold standard' design.

Science.gov (United States)

Mütze, Tobias; Konietschke, Frank; Munk, Axel; Friede, Tim

2017-03-15

The 'gold standard' design for three-arm trials refers to trials with an active control and a placebo control in addition to the experimental treatment group. This trial design is recommended when being ethically justifiable and it allows the simultaneous comparison of experimental treatment, active control, and placebo. Parametric testing methods have been studied plentifully over the past years. However, these methods often tend to be liberal or conservative when distributional assumptions are not met particularly with small sample sizes. In this article, we introduce a studentized permutation test for testing non-inferiority and superiority of the experimental treatment compared with the active control in three-arm trials in the 'gold standard' design. The performance of the studentized permutation test for finite sample sizes is assessed in a Monte Carlo simulation study under various parameter constellations. Emphasis is put on whether the studentized permutation test meets the target significance level. For comparison purposes, commonly used Wald-type tests, which do not make any distributional assumptions, are included in the simulation study. The simulation study shows that the presented studentized permutation test for assessing non-inferiority in three-arm trials in the 'gold standard' design outperforms its competitors, for instance the test based on a quasi-Poisson model, for count data. The methods discussed in this paper are implemented in the R package ThreeArmedTrials which is available on the comprehensive R archive network (CRAN). Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

78 FR 33798 - Oral Rabies Vaccine Trial; Availability of a Supplemental Environmental Assessment

Science.gov (United States)

2013-06-05

... Inspection Service [Docket No. APHIS-2013-0046] Oral Rabies Vaccine Trial; Availability of a Supplemental... Inspection Service has prepared a supplemental environmental assessment (EA) relative to an oral rabies... analyzes expanding the field trial for an experimental oral rabies vaccine for wildlife to additional areas...

Nubia's mother: being pregnant in the time of experimental vaccines and therapeutics for Ebola.

Science.gov (United States)

Caluwaerts, Séverine

2017-12-14

During the 2014-2016 Ebola epidemic, Médecins Sans Frontières (MSF) treated Ebola-positive pregnant women in its Ebola Treatment Centers (ETCs). For pregnant women with confirmed Ebola virus disease, inclusion in clinical vaccine/drug/therapeutic trials was complicated. Despite their extremely high Ebola-related mortality in previous epidemics (89-93%) and a neonatal mortality of 100%, theoretical concerns about safety of vaccines and therapeutics in pregnancy were invoked, limiting pregnant women's access to an experimental live attenuated vaccine and brincidofovir, an experimental antiviral. Favipiravir, another experimental antiviral, was made available to pregnant women only after extensive negotiations and under a 'Monitored Emergency Use of Unregistered and Experimental Interventions' (MEURI) protocol. This paper describes the case of a pregnant woman who presented to the ETCs near the end of the Ebola epidemic in Guinea. The pregnant patient was admitted with confirmed Ebola disease. She was previously denied access to potentially protective vaccination due to pregnancy, and access to experimental ZMapp was only possible through a randomized clinical trial (presenting a 50% chance of not receiving ZMapp). She received favipiravir, but died of Ebola-related complications. The infant, born in the ETC, tested positive for Ebola at birth. The infant received ZMapp (under MEURI access outside of the clinical trial), an experimental drug GS5734, and a buffy coat of an Ebola survivor, and survived. Though the infant did have access to experimental therapeutics within 24 h of birth, access to other experimental compounds for her mother was denied, raising serious ethical concerns.

Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps in a Medicaid managed care plan: study protocol

Directory of Open Access Journals (Sweden)

Ratanawongsa Neda

2012-01-01

Full Text Available Abstract Background Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps. Methods/Design This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252, primary outcomes will be

Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol

Science.gov (United States)

2012-01-01

Background Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps). Methods/Design This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and

Intravenous saline administration in patients with severe acquired brain injury and orthostatic intolerance for tilt-table mobilization

DEFF Research Database (Denmark)

Riberholt, Christian; Olesen, Niels; Hovind, Peter

2018-01-01

Primary objective: This study aimed to investigate the effect of intravenous saline administration on orthostatic hypotension (OH) during head up tilt (HUT) and the change in the renin–angiotensin–aldosterone system before and after HUT in patients with severe acquired brain injury (ABI). Research...... artery blood flow velocity. Blood samples were collected before and after two HUT sessions separated by 1 hour and saline was administered in between. Main outcomes and results: Patients’ ability to stand upright did not change after saline administration due to OH. The patients showed signs of reduced...... fluid administration. Research focusing on the ability to retain fluid after bed rest is warranted....

Single-trial regression elucidates the role of prefrontal theta oscillations in response conflict

NARCIS (Netherlands)

Cohen, M.X.; Cavanagh, J.F.

2011-01-01

In most cognitive neuroscience experiments there are many behavioral and experimental dynamics, and many indices of brain activity, that vary from trial to trial. For example, in studies of response conflict, conflict is usually treated as a binary variable (i.e., response conflict exists or does

Inactive trials of transport systems

International Nuclear Information System (INIS)

Haberlin, M.M.; Hardy, A.R.

1985-06-01

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

The net effect of alternative allocation ratios on recruitment time and trial cost.

Science.gov (United States)

Vozdolska, Ralitza; Sano, Mary; Aisen, Paul; Edland, Steven D

2009-04-01

Increasing the proportion of subjects allocated to the experimental treatment in controlled clinical trials is often advocated as a method of increasing recruitment rates and improving the performance of trials. The presumption is that the higher likelihood of randomization to the experimental treatment will be perceived by potential study enrollees as an added benefit of participation and will increase recruitment rates and speed the completion of trials. However, studies with alternative allocation ratios require a larger sample size to maintain statistical power, which may result in a net increase in time required to complete recruitment and a net increase in total trial cost. To describe the potential net effect of alternative allocation ratios on recruitment time and trial cost. Models of recruitment time and trial cost were developed and used to compare trials with 1:1 allocation to trials with alternative allocation ratios under a range of per subject costs, per day costs, and enrollment rates. In regard to time required to complete recruitment, alternative allocation ratios are net beneficial if the recruitment rate improves by more than about 4% for trials with a 1.5:1 allocation ratio and 12% for trials with a 2:1 allocation ratio. More substantial improvements in recruitment rate, 13 and 47% respectively for scenarios we considered, are required for alternative allocation to be net beneficial in terms of tangible monetary cost. The cost models were developed expressly for trials comparing proportions or means across treatment groups. Using alternative allocation ratio designs to improve recruitment may or may not be time and cost-effective. Using alternative allocation for this purpose should only be considered for trial contexts where there is both clear evidence that the alternative design does improve recruitment rates and the attained time or cost efficiency justifies the added study subject burden implied by a larger sample size.

Identification of risk factors for plague in the West Nile Region of Uganda.

Science.gov (United States)

Eisen, Rebecca J; MacMillan, Katherine; Atiku, Linda A; Mpanga, Joseph T; Zielinski-Gutierrez, Emily; Graham, Christine B; Boegler, Karen A; Enscore, Russell E; Gage, Kenneth L

2014-06-01

Plague is an often fatal, primarily flea-borne rodent-associated zoonosis caused by Yersinia pestis. We sought to identify risk factors for plague by comparing villages with and without a history of human plague cases within a model-defined plague focus in the West Nile Region of Uganda. Although rat (Rattus rattus) abundance was similar inside huts within case and control villages, contact rates between rats and humans (as measured by reported rat bites) and host-seeking flea loads were higher in case villages. In addition, compared with persons in control villages, persons in case villages more often reported sleeping on reed or straw mats, storing food in huts where persons sleep, owning dogs and allowing them into huts where persons sleep, storing garbage inside or near huts, and cooking in huts where persons sleep. Compared with persons in case villages, persons in control villages more commonly reported replacing thatch roofing, and growing coffee, tomatoes, onions, and melons in agricultural plots adjacent to their homesteads. Rodent and flea control practices, knowledge of plague, distance to clinics, and most care-seeking practices were similar between persons in case villages and persons in control villages. Our findings reinforce existing plague prevention recommendations and point to potentially advantageous local interventions. © The American Society of Tropical Medicine and Hygiene.

Comparison of hen preference for nesting substrate material, and performance in a free range production system

Science.gov (United States)

This project consisted of 200 Hy-Line Brown hens and was conducted utilizing the brood-grow-lay range huts at the North Carolina Department of Agriculture and Consumer Services’ Piedmont Research Station. Fifty hens were placed in each pen/paddock providing 1338 cm2/hen of floor space in the hut an...

Ethics of clinical trials.

Science.gov (United States)

Palter, S F

1996-05-01

The modern clinical trial is a form of human experimentation. There is a long history of disregard for individual rights of the patient in this context, and special attention must be paid to ethical guidelines for these studies. Clinical trials differ in basic ways from clinical practice. Foremost is the introduction of outside interests, beyond those of the patient's health, into the doctor-patient therapeutic alliance. Steps must be taken to protect the interests of the patient when such outside influence exists. Kantian moral theory and the Hippocratic oath dictate that the physician must respect the individual patient's rights and hold such interests paramount. These principles are the basis for informed consent. Randomization of patients is justified when a condition of equipoise exists. The changing nature of health care delivery in the United States introduces new outside interests into the doctor-patient relationship.

75 FR 71699 - Pesticide Experimental Use Permits; Receipt of Amendment and Extension Applications; Comment Request

Science.gov (United States)

2010-11-24

... Food, Drug, and Cosmetic Act (FFDCA) or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA... trials to evaluate insect and herbicide efficacy, agronomic performance, and breeding lines. Also proposed is the production of seed for future plantings of experimental and regulatory field trials...

Go!: results from a quasi-experimental obesity prevention trial with hospital employees

Directory of Open Access Journals (Sweden)

Lara J. LaCaille

2016-02-01

Full Text Available Abstract Background Worksite obesity prevention interventions using an ecological approach may hold promise for reducing typical weight gain. The purpose of this study was to examine the effectiveness of Go!, an innovative 12-month multi-component worksite obesity prevention intervention. Methods A quasi-experimental non-equivalent control group design was utilized; 407 eligible hospital employees (intervention arm and 93 eligible clinic employees (comparison arm participated. The intervention involved pedometer distribution, labeling of all foods in the worksite cafeteria and vending machines (with calories, step equivalent, and a traffic light based on energy density signaling recommended portion, persuasive messaging throughout the hospital, and the integration of influential employees to reinforce healthy social norms. Changes in weight, BMI, waist circumference, physical activity, and dietary behavior after 6 months and 1 year were primary outcomes. Secondary outcomes included knowledge, perceptions of employer commitment to employee health, availability of information about diet, exercise, and weight loss, perceptions of coworker support and frequency of health discussions with coworkers. A process evaluation was conducted as part of the study. Results Repeated measures ANCOVA indicated that neither group showed significant increases in weight, BMI, or waist circumference over 12 months. The intervention group showed a modest increase in physical activity in the form of walking, but decreases in fruit and vegetable servings and fiber intake. They also reported significant increases in knowledge, information, perceptions of employer commitment, and health discussions with peers. Employees expressed positive attitudes towards all components of the Go! intervention. Conclusions This low-intensity intervention was well-received by employees but had little effect on their weight over the course of 12 months. Such results are consistent with

Multiple linear regression to estimate time-frequency electrophysiological responses in single trials.

Science.gov (United States)

Hu, L; Zhang, Z G; Mouraux, A; Iannetti, G D

2015-05-01

Transient sensory, motor or cognitive event elicit not only phase-locked event-related potentials (ERPs) in the ongoing electroencephalogram (EEG), but also induce non-phase-locked modulations of ongoing EEG oscillations. These modulations can be detected when single-trial waveforms are analysed in the time-frequency domain, and consist in stimulus-induced decreases (event-related desynchronization, ERD) or increases (event-related synchronization, ERS) of synchrony in the activity of the underlying neuronal populations. ERD and ERS reflect changes in the parameters that control oscillations in neuronal networks and, depending on the frequency at which they occur, represent neuronal mechanisms involved in cortical activation, inhibition and binding. ERD and ERS are commonly estimated by averaging the time-frequency decomposition of single trials. However, their trial-to-trial variability that can reflect physiologically-important information is lost by across-trial averaging. Here, we aim to (1) develop novel approaches to explore single-trial parameters (including latency, frequency and magnitude) of ERP/ERD/ERS; (2) disclose the relationship between estimated single-trial parameters and other experimental factors (e.g., perceived intensity). We found that (1) stimulus-elicited ERP/ERD/ERS can be correctly separated using principal component analysis (PCA) decomposition with Varimax rotation on the single-trial time-frequency distributions; (2) time-frequency multiple linear regression with dispersion term (TF-MLRd) enhances the signal-to-noise ratio of ERP/ERD/ERS in single trials, and provides an unbiased estimation of their latency, frequency, and magnitude at single-trial level; (3) these estimates can be meaningfully correlated with each other and with other experimental factors at single-trial level (e.g., perceived stimulus intensity and ERP magnitude). The methods described in this article allow exploring fully non-phase-locked stimulus-induced cortical

Evaluation of a musculoskeletal model with prosthetic knee through six experimental gait trials.

Science.gov (United States)

Kia, Mohammad; Stylianou, Antonis P; Guess, Trent M

2014-03-01

Knowledge of the forces acting on musculoskeletal joint tissues during movement benefits tissue engineering, artificial joint replacement, and our understanding of ligament and cartilage injury. Computational models can be used to predict these internal forces, but musculoskeletal models that simultaneously calculate muscle force and the resulting loading on joint structures are rare. This study used publicly available gait, skeletal geometry, and instrumented prosthetic knee loading data [1] to evaluate muscle driven forward dynamics simulations of walking. Inputs to the simulation were measured kinematics and outputs included muscle, ground reaction, ligament, and joint contact forces. A full body musculoskeletal model with subject specific lower extremity geometries was developed in the multibody framework. A compliant contact was defined between the prosthetic femoral component and tibia insert geometries. Ligament structures were modeled with a nonlinear force-strain relationship. The model included 45 muscles on the right lower leg. During forward dynamics simulations a feedback control scheme calculated muscle forces using the error signal between the current muscle lengths and the lengths recorded during inverse kinematics simulations. Predicted tibio-femoral contact force, ground reaction forces, and muscle forces were compared to experimental measurements for six different gait trials using three different gait types (normal, trunk sway, and medial thrust). The mean average deviation (MAD) and root mean square deviation (RMSD) over one gait cycle are reported. The muscle driven forward dynamics simulations were computationally efficient and consistently reproduced the inverse kinematics motion. The forward simulations also predicted total knee contact forces (166Nphysiological motor control patterns during gait. Consequently, the simulations did not accurately predict medial/lateral tibio-femoral force distribution and muscle activation timing. Copyright

Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol.

Science.gov (United States)

Ratanawongsa, Neda; Handley, Margaret A; Quan, Judy; Sarkar, Urmimala; Pfeifer, Kelly; Soria, Catalina; Schillinger, Dean

2012-01-26

Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps). This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and functional status with

2016 Louisiana “Ho” nursery variety trials

Science.gov (United States)

In the Sugarcane Research Unit’s sugarcane variety program, promising experimental varieties are assigned permanent “HoCP” or “Ho” numbers three years after selection in the seedling stage. These varieties are then planted in replicated yield trials at USDA’s Ardoyne Farm in Schriever and at the LS...

Arterial wave reflection decreases gradually from supine to upright

DEFF Research Database (Denmark)

van den Bogaard, Bas; Westerhof, Berend E; Best, Hendrik

2011-01-01

BACKGROUND. An increase in total peripheral resistance (TPR) usually increases arterial wave reflection. During passive head-up tilt (HUT), however, arterial wave reflection decreases with increasing TPR. This study addressed whether arterial wave reflection gradually decreases during HUT. METHODS....... In 10 healthy volunteers (22-39 years, nine males), we recorded finger arterial pressures in supine position (0°), and 30°and 70°degrees HUT and active standing (90°). Aortic pressure was constructed from the finger pressure signal and hemodynamics were calculated. Arterial wave reflection...... from 0.9 dyn s/cm(5) at 0? to 1.2, 1.4 and 1.4 dyn s/cm(5) at 30°, 70° and 90° (p wave reflection...

Rating the methodological quality of single-subject designs and n-of-1 trials: introducing the Single-Case Experimental Design (SCED) Scale.

Science.gov (United States)

Tate, Robyn L; McDonald, Skye; Perdices, Michael; Togher, Leanne; Schultz, Regina; Savage, Sharon

2008-08-01

Rating scales that assess methodological quality of clinical trials provide a means to critically appraise the literature. Scales are currently available to rate randomised and non-randomised controlled trials, but there are none that assess single-subject designs. The Single-Case Experimental Design (SCED) Scale was developed for this purpose and evaluated for reliability. Six clinical researchers who were trained and experienced in rating methodological quality of clinical trials developed the scale and participated in reliability studies. The SCED Scale is an 11-item rating scale for single-subject designs, of which 10 items are used to assess methodological quality and use of statistical analysis. The scale was developed and refined over a 3-year period. Content validity was addressed by identifying items to reduce the main sources of bias in single-case methodology as stipulated by authorities in the field, which were empirically tested against 85 published reports. Inter-rater reliability was assessed using a random sample of 20/312 single-subject reports archived in the Psychological Database of Brain Impairment Treatment Efficacy (PsycBITE). Inter-rater reliability for the total score was excellent, both for individual raters (overall ICC = 0.84; 95% confidence interval 0.73-0.92) and for consensus ratings between pairs of raters (overall ICC = 0.88; 95% confidence interval 0.78-0.95). Item reliability was fair to excellent for consensus ratings between pairs of raters (range k = 0.48 to 1.00). The results were replicated with two independent novice raters who were trained in the use of the scale (ICC = 0.88, 95% confidence interval 0.73-0.95). The SCED Scale thus provides a brief and valid evaluation of methodological quality of single-subject designs, with the total score demonstrating excellent inter-rater reliability using both individual and consensus ratings. Items from the scale can also be used as a checklist in the design, reporting and critical

Terminal illness and access to Phase 1 experimental agents, surgeries and devices: reviewing the ethical arguments.

Science.gov (United States)

Schüklenk, Udo; Lowry, Christopher

2009-01-01

The advent of AIDS brought about a group of patients unwilling to accept crucial aspects of the methodological standards for clinical research investigating Phase 1 drugs, surgeries or devices. Their arguments against placebo controls in trials, which depended--at the time--on the terminal status of patient volunteers led to a renewed discussion of the ethics of denying patients with catastrophic illnesses access to last-chance experimental drugs, surgeries or devices. Existing ethics and health policy literature on the topic of access to experimental drugs. The positions of those arguing for or against free access to experimental drugs for terminally ill patients are irreconcilable. At stake are questions about the kinds of personal sacrifices society can reasonably expect patients in clinical trials to make to ensure statistically predictive results. These would benefit by necessity a much larger number of current and future patients--the conflict is about individual versus public interests. It is also about the question of whether or not the state can legitimately prevent patients with terminal illnesses from unfettered access to experimental drugs, surgeries or devices in order to motivate them to participate in clinical trials. We review the ethical arguments for and against the provision of access to Phase 1 agents for terminally ill patients. Finding a compromise between providing free or no access to Phase 1 drugs for terminally ill patients. We ought to investigate means to increase access to experimental drugs for terminally ill patients without sacrificing necessary clinical trials' sounds scientific methods.

Counterbalancing for serial order carryover effects in experimental condition orders

OpenAIRE

Brooks, Joseph L

2012-01-01

Reactions of neural, psychological, and social systems are rarely, if ever, independent of previous inputs and states. The potential for serial order carryover effects from one condition to the next in a sequence of experimental trials makes counterbalancing of condition order an essential part of experimental design. Here, a method is proposed for generating counterbalanced sequences for repeated-measures designs including those with multiple observations of each condition on one participant...

Northwestern University trial emerging optical solutions

CERN Multimedia

2001-01-01

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

Dose-specific effects of transcutaneous electrical nerve stimulation (TENS) on experimental pain: a systematic review.

Science.gov (United States)

Claydon, Leica S; Chesterton, Linda S; Barlas, Panos; Sim, Julius

2011-09-01

To determine the hypoalgesic effects of transcutaneous electrical nerve stimulation (TENS) parameter combinations on experimental models in healthy humans. Searches were performed using the electronic databases Ovid MEDLINE, CINAHL, AMED, and Web of Science (from inception to December 2009). Manual searches of journals and reference lists of retrieved trials were also performed. Randomized controlled trials (RCTs) were included in the review if they compared the hypoalgesic effect of TENS relative with placebo and control, using an experimental pain model in healthy human participants. Two reviewers independently selected the trials, assessed their methodologic quality and extracted data. Forty-three RCTs were eligible for inclusion. A best evidence synthesis revealed: Overall "conflicting" (inconsistent findings in multiple RCTs) evidence of TENS efficacy on experimental pain irrespective of TENS parameters used. Overall intense TENS has "moderate" evidence of efficacy (1 high-quality and 2 low-quality trials). Conventional TENS has overall conflicting evidence of efficacy, this is derived from "strong" evidence of efficacy (generally consistent findings in multiple high-quality RCTs) on pressure pain but strong evidence of inefficacy on other pain models. "Limited" evidence (positive findings from 1 RCT) of hypoalgesia exists for some novel parameters. Low-intensity, low-frequency, local TENS has strong evidence of inefficacy. Inappropriate TENS (using "barely perceptible" intensities) has moderate evidence of inefficacy. The level of hypoalgesic efficacy of TENS is clearly dependent on TENS parameter combination selection (defined in terms of intensity, frequency, and stimulation site) and experimental pain model. Future clinical RCTs may consider these TENS dose responses.

Effect of acute exposure to hypergravity (GX vs. GZ) on dynamic cerebral autoregulation

Science.gov (United States)

Serrador, J. M.; Wood, S. J.; Picot, P. A.; Stein, F.; Kassam, M. S.; Bondar, R. L.; Rupert, A. H.; Schlegel, T. T.

2001-01-01

We examined the effects of 30 min of exposure to either +3GX (front-to-back) or +GZ (head-to-foot) centrifugation on cerebrovascular responses to 80 degrees head-up tilt (HUT) in 14 healthy individuals. Both before and after +3 GX or +3 GZ centrifugation, eye-level blood pressure (BP(eye)), end tidal PCO2 (PET(CO2)), mean cerebral flow velocity (CFV) in the middle cerebral artery (transcranial Doppler ultrasound), cerebral vascular resistance (CVR), and dynamic cerebral autoregulatory gain (GAIN) were measured with subjects in the supine position and during subsequent 80 degrees HUT for 30 min. Mean BP(eye) decreased with HUT in both the GX (n = 7) and GZ (n = 7) groups (P centrifugation only in the GZ group (P centrifugation. CFV decreased during HUT more significantly after centrifugation than before centrifugation in both groups (P centrifugation compared with before centrifugation, GAIN increased in both groups (P centrifugation resulted in a leftward shift of the cerebral autoregulation curve. We speculate that this leftward shift may have been due to vestibular activation (especially during +GX) or potentially to an adaptation to reduced cerebral perfusion pressure during +GZ.

Gaseous emissions in pressurised fluidised-bed combustion. Analysis and summary of the pilot experiments

International Nuclear Information System (INIS)

Korpela, T.; Hippinen, I.; Konkola, M.

1996-01-01

The influence of operating conditions on gaseous emissions in pressurised fluidised-bed combustion have been studied. The research objectives have been behaviour of sulphur absorbents and reduction of sulphur dioxide emissions, reduction of nitrogen oxide emissions, release of vapour-phase alkalimetals and carbon monoxide emissions. The sulphur capture capacities of calcium-based sorbents under PFBC conditions have been studied at a pressurised fluidised-bed reactor and at a pressurised thermogravimetric apparatus. The project has also connected results of the experimental PFBC at HUT/EVO. (author)

Gaseous emissions in pressurised fluidised-bed combustion. Analysis and summary of the pilot experiments; Kaasumaiset paeaestoet paineistetussa leijukerrospoltossa. Koetulosten kaesittely ja yhteenveto

Energy Technology Data Exchange (ETDEWEB)

Korpela, T.; Hippinen, I.; Konkola, M. [Helsinki Univ. of Technology, Espoo (Finland)

1996-12-01

The influence of operating conditions on gaseous emissions in pressurised fluidised-bed combustion have been studied. The research objectives have been behaviour of sulphur absorbents and reduction of sulphur dioxide emissions, reduction of nitrogen oxide emissions, release of vapour-phase alkalimetals and carbon monoxide emissions. The sulphur capture capacities of calcium-based sorbents under PFBC conditions have been studied at a pressurised fluidised-bed reactor and at a pressurised thermogravimetric apparatus. The project has also connected results of the experimental PFBC at HUT/EVO. (author)

The Experimental Role of Accounting in Shaping Project

DEFF Research Database (Denmark)

Christensen, Mark; Skærbæk, Peter; Tryggestad, Kjell

2016-01-01

, 2009) and the literature on accounting as programs (Miller, 1991, Miller and Power, 2013) by showing how accounting plays an experimental role in shaping the dynamics between a New Public Management programme of outsourcing and its projects. The study illuminates decisionmaking about programs...... and strategic options as a trial of strength involving accounting in an experimental role, in our case, over how to source the facilities management in the Danish Defence Forces. Our contribution is to show how accounting plays an experimental role in generating new and unexpected program options...... of economic experiments with (out-)sourcing options using various accounting data such as; location specific cost data in vivo (real life data like those from the accounting system) for individual barracks, and aggregated cost data and cost projections in vitro ( in a controlled experimental project setting...

Evidence-based intervention against bullying and cyberbullying: Evaluation of the NoTrap! program in two independent trials.

Science.gov (United States)

Palladino, Benedetta E; Nocentini, Annalaura; Menesini, Ersilia

2016-01-01

The NoTrap! (Noncadiamointrappola!) program is a school-based intervention, which utilizes a peer-led approach to prevent and combat both traditional bullying and cyberbullying. The aim of the present study was to evaluate the efficacy of the third Edition of the program in accordance with the recent criteria for evidence-based interventions. Towards this aim, two quasi-experimental trials involving adolescents (age M = 14.91, SD = .98) attending their first year at different high schools were conducted. In Trial 1 (control group, n = 171; experimental group, n = 451), latent growth curve models for data from pre-, middle- and post-tests showed that intervention significantly predicted change over time in all the target variables (victimization, bullying, cybervictimization, and cyberbullying). Specifically, target variables were stable for the control group but decreased significantly over time for the experimental group. Long-term effects at the follow up 6 months later were also found. In Trial 2 (control group, n = 227; experimental group, n = 234), the moderating effect of gender was examined and there was a reported decrease in bullying and cyberbullying over time (pre- and post-test) in the experimental group but not the control group, and this decrease was similar for boys and girls. © 2016 Wiley Periodicals, Inc.

Hemodynamic response to exercise and head-up tilt of patients implanted with a rotary blood pump: a computational modeling study.

Science.gov (United States)

Lim, Einly; Salamonsen, Robert Francis; Mansouri, Mahdi; Gaddum, Nicholas; Mason, David Glen; Timms, Daniel L; Stevens, Michael Charles; Fraser, John; Akmeliawati, Rini; Lovell, Nigel Hamilton

2015-02-01

The present study investigates the response of implantable rotary blood pump (IRBP)-assisted patients to exercise and head-up tilt (HUT), as well as the effect of alterations in the model parameter values on this response, using validated numerical models. Furthermore, we comparatively evaluate the performance of a number of previously proposed physiologically responsive controllers, including constant speed, constant flow pulsatility index (PI), constant average pressure difference between the aorta and the left atrium, constant average differential pump pressure, constant ratio between mean pump flow and pump flow pulsatility (ratioP I or linear Starling-like control), as well as constant left atrial pressure ( P l a ¯ ) control, with regard to their ability to increase cardiac output during exercise while maintaining circulatory stability upon HUT. Although native cardiac output increases automatically during exercise, increasing pump speed was able to further improve total cardiac output and reduce elevated filling pressures. At the same time, reduced venous return associated with upright posture was not shown to induce left ventricular (LV) suction. Although P l a ¯ control outperformed other control modes in its ability to increase cardiac output during exercise, it caused a fall in the mean arterial pressure upon HUT, which may cause postural hypotension or patient discomfort. To the contrary, maintaining constant average pressure difference between the aorta and the left atrium demonstrated superior performance in both exercise and HUT scenarios. Due to their strong dependence on the pump operating point, PI and ratioPI control performed poorly during exercise and HUT. Our simulation results also highlighted the importance of the baroreflex mechanism in determining the response of the IRBP-assisted patients to exercise and postural changes, where desensitized reflex response attenuated the percentage increase in cardiac output during exercise and

Experimental melanoma metastasis in lungs of mice with congenital coagulation disorders

NARCIS (Netherlands)

Brüggemann, Lois W.; Versteeg, Henri H.; Niers, Tatjana M.; Reitsma, Pieter H.; Spek, C. Arnold

2008-01-01

Experimental animal studies as well as clinical trials have shown that interventions targeting the blood coagulation cascade inhibit cancer cell metastasis. These data support the hypothesis that congenital prothrombotic disorders, like factor V Leiden, facilitate metastasis whereas bleeding

Influences on visit retention in clinical trials: insights from qualitative research during the VOICE trial in Johannesburg, South Africa.

Science.gov (United States)

Magazi, Busisiwe; Stadler, Jonathan; Delany-Moretlwe, Sinead; Montgomery, Elizabeth; Mathebula, Florence; Hartmann, Miriam; van der Straten, Ariane

2014-07-28

Although significant progress has been made in clinical trials of women-controlled methods of HIV prevention such as microbicides and Pre-exposure Prophylaxis (PrEP), low adherence to experimental study products remains a major obstacle to being able to establish their efficacy in preventing HIV infection. One factor that influences adherence is the ability of trial participants to attend regular clinic visits at which trial products are dispensed, adherence counseling is administered, and participant safety is monitored. We conducted a qualitative study of the social contextual factors that influenced adherence in the VOICE (MTN-003) trial in Johannesburg, South Africa, focusing on study participation in general, and study visits in particular. The research used qualitative methodologies, including in-depth interviews (IDI), serial ethnographic interviews (EI), and focus group discussions (FGD) among a random sub-sample of 102 female trial participants, 18 to 40 years of age. A socio-ecological framework that explored those factors that shaped trial participation and adherence to study products, guided the analysis. Key codes were developed to standardize subsequent coding and a node search was used to identify texts relating to obstacles to visit adherence. Our analysis includes coded transcripts from seven FGD (N = 40), 41 IDI, and 64 serial EI (N = 21 women). Women's kinship, social, and economic roles shaped their ability to participate in the clinical trial. Although participants expressed strong commitments to attend study visits, clinic visit schedules and lengthy waiting times interfered with their multiple obligations as care givers, wage earners, housekeepers, and students. The research findings highlight the importance of the social context in shaping participation in HIV prevention trials, beyond focusing solely on individual characteristics. This points to the need to focus interventions to improve visit attendance by promoting a culture of

Mexican-American perspectives on participation in clinical trials: A qualitative study

Directory of Open Access Journals (Sweden)

Mariana Arevalo

2016-12-01

Full Text Available Clinical trials are essential to advancing knowledge to reduce disease morbidity and mortality; however, ethnic and racial minorities remain under-represented in those studies. We explored knowledge and perceptions of clinical trials among Mexican-Americans in Texas. We conducted focus groups (N = 128 stratified by gender, language preference, and geographical location. This paper presents four emergent, primary themes: 1 knowledge and understanding of clinical trials, 2 fears and concerns about participating, 3 perceived benefits of participating, and 4 incentives to participate. Results suggest that lack of knowledge and understanding of clinical trials leads to misunderstanding about research, including fears and lack of trust. Participants indicated that fears related to perceived experimentation, harm, immigration status, and lack of clinical trial opportunities within their communities were barriers to participation. On the other hand, free healthcare access, helping family members in the future, and monetary incentives could facilitate participation. We also found differences across themes by language, gender, and place of residence. Findings from our study could inform the development of interventions to enhance recruitment of Mexican-American participants into clinical trials.

Experimental and clinical trial of measuring urinary velocity with the pitot tube and a transrectal ultrasound guided video urodynamic system.

Science.gov (United States)

Tsujimoto, Yukio; Nose, Yorihito; Ohba, Kenkichi

2003-01-01

The pitot tube is a common device to measure flow velocity. If the pitot tube is used as an urodynamic catheter, urinary velocity and urethral pressure may be measured simultaneously. However, to our knowledge, urodynamic studies with the pitot tube have not been reported. We experimentally and clinically evaluated the feasibility of the pitot tube to measure urinary velocity with a transrectal ultrasound guided video urodynamic system. We carried out a basal experiment measuring flow velocity in model urethras of 4.5-8.0 mm in inner diameter with a 12-Fr pitot tube. In a clinical trial, 79 patients underwent transrectal ultrasound guided video urodynamic studies with the 12-Fr pitot tube. Urinary velocity was calculated from dynamic pressure (Pd) with the pitot tube formula and the correcting equation according to the results of the basal experiment. Velocity measured by the pitot tube was proportional to the average velocity in model urethras and the coefficients were determined by diameters of model urethras. We obtained a formula to calculate urinary velocity from the basal experiment. The urinary velocity could be obtained in 32 of 79 patients. Qmax was 8.1 +/- 4.3 mL/s (mean +/- SD; range, 18.4-1.3 mL/s), urethral diameter was 7.3 +/- 3.0 mm (mean +/- SD; range, 18.7-4.3 mm) and urinary velocity was 69.4 +/- 43.6 (mean +/- SD; range, 181.3-0 cm/s) at maximum flow rate. The correlation coefficient of Qmax measured by a flowmeter versus Qdv flow rate calculated with urethral diameter and velocity was 0.41 without significant difference. The use of the pitot tube as an urodynamic catheter to a transrectal ultrasound-guided video urodynamic system can measure urethral pressure, diameter and urinary velocity simultaneously. However, a thinner pitot tube and further clinical trials are needed to obtain more accurate results.

Inflammatory pain in experimental burns in man

DEFF Research Database (Denmark)

Pedersen, J L

2000-01-01

stimuli may be more reproducible. A methodological study also demonstrated that habituation to experimental pain developed as the study proceeded. Habituation is common in experimental pain models, and dividing analgesics and placebo evenly between the study days is one way of eliminating the effects......Human experimental pain models are important tools in pain research. The primary aims of pain research in normal man is 1) to provide insight in pain mechanisms, 2) to provide a rational basis for clinical trials of pain relieving interventions, and 3) to confirm the anti-nociceptive effects...... demonstrated in animal models. Most often clinical pain is due to tissue damage leading to acute inflammation and hyperalgesia, but only few human pain models have examined pain responses in injured tissues. Therefore, models with controlled and reversible tissue trauma are needed. The human burn model...

Hydrolysable chestnut tannins for reduction of postweaning diarrhea: Efficacy on an experimental ETEC F4 model.

Science.gov (United States)

Girard, Marion; Thanner, Sophie; Pradervand, Nicolas; Hu, Dou; Ollagnier, Catherine; Bee, Giuseppe

2018-01-01

An experimental model for postweaning diarrhea with enterotoxigenic Escherichia coli F4 (ETEC F4) was set up in piglets, and the efficacy of 1% chestnut-tannin extract in preventing diarrhea was subsequently assessed. In a first trial (infection model), 32 Swiss Large White piglets (age: 24 days; average BW: 7.8 ± 0.8 kg) were randomly assigned to two experimental groups (infected [INF], noninfected [NINF]). In a subsequent trial, 72 Swiss Large White piglets (age: 26 days; average BW: 7.4 ± 1.5 kg) were blocked by BW and assigned within block to four experimental groups: NINF-CO: not infected and fed a standard control starter diet (CO); INF-CO: infected and fed the CO diet; NINF-TA: not infected and fed the CO diet supplemented with 1% chestnut extract containing 54% of hydrolysable tannins (TA); and INF-TA: infected and fed the TA diet. Both diets (TA and CO) were formulated to be isocaloric and isoproteic and to meet or surpass the nutritional requirements. In both trials, four days after weaning, piglets assigned to the INF group received an oral suspension of ETEC F4. Fecal score, ETEC shedding in feces (only in trial 2), and growth performance traits were measured for the following 14 days post infection. In both trials, more than 50% of the INF piglets developed diarrhea within six days post infection. Tannins reduced (P < 0.05) the average fecal score, the percentage of piglets in diarrhea, and the duration of diarrhea, whereas feed intake and the average daily gain were unaffected.

Experimental Implementation of a Passive Millimeter-Wave Fast Sequential Lobing Radiometric Seeker Sensor

OpenAIRE

Massimiliano Rossi; Riccardo Maria Liberati; Marco Frasca; Mauro Angelini

2018-01-01

The paper investigates the theory of operation of a passive millimeter-wave seeker sensor using a fast electronic sequential-lobing technique and the experimental validation obtained through laboratory trials. The paper analyzes in detail the theoretical performance of a difference channel sensor and a pseudo-monopulse sensor deriving agile formulas for the estimation of target angular tracking accuracy and the subsequent experimental validation.

Informed consent for clinical trials of deep brain stimulation in psychiatric disease: challenges and implications for trial design.

Science.gov (United States)

Lipsman, Nir; Giacobbe, Peter; Bernstein, Mark; Lozano, Andres M

2012-02-01

Advances in neuromodulation and an improved understanding of the anatomy and circuitry of psychopathology have led to a resurgence of interest in surgery for psychiatric disease. Clinical trials exploring deep brain stimulation (DBS), a focally targeted, adjustable and reversible form of neurosurgery, are being developed to address the use of this technology in highly selected patient populations. Psychiatric patients deemed eligible for surgical intervention, such as DBS, typically meet stringent inclusion criteria, including demonstrated severity, chronicity and a failure of conventional therapy. Although a humanitarian device exemption by the US Food and Drug Administration exists for its use in obsessive-compulsive disorder, DBS remains a largely experimental treatment in the psychiatric context, with its use currently limited to clinical trials and investigative studies. The combination of a patient population at the limits of conventional therapy and a novel technology in a new indication poses interesting challenges to the informed consent process as it relates to clinical trial enrollment. These challenges can be divided into those that relate to the patient, their disease and the technology, with each illustrating how traditional conceptualisations of research consent may be inadequate in the surgical psychiatry context. With specific reference to risk analysis, patient autonomy, voluntariness and the duty of the clinician-researcher, this paper will discuss the unique challenges that clinical trials of surgery for refractory psychiatric disease present to the consent process. Recommendations are also made for an ethical approach to clinical trial consent acquisition in this unique patient population.

How to Evaluate Phase Differences between Trial Groups in Ongoing Electrophysiological Signals

Science.gov (United States)

VanRullen, Rufin

2016-01-01

A growing number of studies endeavor to reveal periodicities in sensory and cognitive functions, by comparing the distribution of ongoing (pre-stimulus) oscillatory phases between two (or more) trial groups reflecting distinct experimental outcomes. A systematic relation between the phase of spontaneous electrophysiological signals, before a stimulus is even presented, and the eventual result of sensory or cognitive processing for that stimulus, would be indicative of an intrinsic periodicity in the underlying neural process. Prior studies of phase-dependent perception have used a variety of analytical methods to measure and evaluate phase differences, and there is currently no established standard practice in this field. The present report intends to remediate this need, by systematically comparing the statistical power of various measures of “phase opposition” between two trial groups, in a number of real and simulated experimental situations. Seven measures were evaluated: one parametric test (circular Watson-Williams test), and three distinct measures of phase opposition (phase bifurcation index, phase opposition sum, and phase opposition product) combined with two procedures for non-parametric statistical testing (permutation, or a combination of z-score and permutation). While these are obviously not the only existing or conceivable measures, they have all been used in recent studies. All tested methods performed adequately on a previously published dataset (Busch et al., 2009). On a variety of artificially constructed datasets, no single measure was found to surpass all others, but instead the suitability of each measure was contingent on several experimental factors: the time, frequency, and depth of oscillatory phase modulation; the absolute and relative amplitudes of post-stimulus event-related potentials for the two trial groups; the absolute and relative trial numbers for the two groups; and the number of permutations used for non-parametric testing

Laboratory of High resolution gamma spectrometry; Laboratorio de espectrometria gamma de alta resolucion

Energy Technology Data Exchange (ETDEWEB)

Mendez G, A.; Giber F, J.; Rivas C, I.; Reyes A, B

1992-01-15

The Department of Nuclear Experimentation of the Nuclear Systems Management requests the collaboration of the Engineering unit for the supervision of the execution of the work of the High resolution Gamma spectrometry and low bottom laboratory, using the hut of the sub critic reactor of the Nuclear Center of Mexico. This laboratory has the purpose of determining the activity of special materials irradiated in nuclear power plants. In this report the architecture development, concepts, materials and diagrams for the realization of this type of work are presented. (Author)

Laboratory of High resolution gamma spectrometry

International Nuclear Information System (INIS)

Mendez G, A.; Giber F, J.; Rivas C, I.; Reyes A, B.

1992-01-01

The Department of Nuclear Experimentation of the Nuclear Systems Management requests the collaboration of the Engineering unit for the supervision of the execution of the work of the High resolution Gamma spectrometry and low bottom laboratory, using the hut of the sub critic reactor of the Nuclear Center of Mexico. This laboratory has the purpose of determining the activity of special materials irradiated in nuclear power plants. In this report the architecture development, concepts, materials and diagrams for the realization of this type of work are presented. (Author)

Evaluating the design and reporting of pragmatic trials in osteoarthritis research.

Science.gov (United States)

Ali, Shabana Amanda; Kloseck, Marita; Lee, Karen; Walsh, Kathleen Ellen; MacDermid, Joy C; Fitzsimmons, Deborah

2018-01-01

Among the challenges in health research is translating interventions from controlled experimental settings to clinical and community settings where chronic disease is managed daily. Pragmatic trials offer a method for testing interventions in real-world settings but are seldom used in OA research. The aim of this study was to evaluate the literature on pragmatic trials in OA research up to August 2016 in order to identify strengths and weaknesses in the design and reporting of these trials. We used established guidelines to assess the degree to which 61 OA studies complied with pragmatic trial design and reporting. We assessed design according to the pragmatic-explanatory continuum indicator summary and reporting according to the pragmatic trials extension of the CONsolidated Standards of Reporting Trials guidelines. None of the pragmatic trials met all 11 criteria evaluated and most of the trials met between 5 and 8 of the criteria. Criteria most often unmet pertained to practitioner expertise (by requiring specialists) and criteria most often met pertained to primary outcome analysis (by using intention-to-treat analysis). Our results suggest a lack of highly pragmatic trials in OA research. We identify this as a point of opportunity to improve research translation, since optimizing the design and reporting of pragmatic trials can facilitate implementation of evidence-based interventions for OA care. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Two controlled trials to increase participant retention in a randomized controlled trial of mobile phone-based smoking cessation support in the United Kingdom.

Science.gov (United States)

Severi, Ettore; Free, Caroline; Knight, Rosemary; Robertson, Steven; Edwards, Philip; Hoile, Elizabeth

2011-10-01

Loss to follow-up of trial participants represents a threat to research validity. To date, interventions designed to increase participants' awareness of benefits to society of completing follow-up, and the impact of a telephone call from a senior female clinician and researcher requesting follow-up have not been evaluated robustly. Trial 1 aimed to evaluate the effect on trial follow-up of written information regarding the benefits of participation to society. Trial 2 aimed to evaluate the effect on trial follow-up of a telephone call from a senior female clinician and researcher. Two single-blind randomized controlled trials were nested within a larger trial, Txt2stop. In Trial 1, participants were allocated using minimization to receive a refrigerator magnet and a text message emphasizing the benefits to society of completing follow-up, or to a control group receiving a simple reminder regarding follow-up. In Trial 2, participants were randomly allocated to receive a telephone call from a senior female clinician and researcher, or to a control group receiving standard Txt2stop follow-up procedures. Trial 1: 33.5% (327 of 976) of the intervention group and 33.8% (329 of 974) of the control group returned the questionnaire within 26 weeks of randomization, risk ratio (RR) 0.99; 95% confidence interval (CI) 0.88-1.12. In all, 83.3% (813 of 976) of the intervention group and 82.2% (801 of/974) of the control group sent back the questionnaire within 30 weeks of randomization, RR 1.01; 95% CI 0.97, 1.05. Trial 2: 31% (20 of 65) of the intervention group and 32% (20 of 62) of the control group completed trial follow-up, RR 0.93; 95%CI 0.44, 1.98. In presence of other methods to increase follow-up neither experimental method (refrigerator magnet and text message emphasizing participation's benefits to society nor a telephone call from study's principal investigator) increased participant follow-up in the Txt2stop trial.

Sitting and standing blood pressure measurements are not accurate for the diagnosis of orthostatic hypotension.

LENUS (Irish Health Repository)

Cooke, J

2012-01-31

INTRODUCTION: Orthostatic hypotension (OH) is associated with troublesome symptoms and increased mortality. It is treatable and deserving of accurate diagnosis. This can be time consuming. The current reference standard for its diagnosis is head-up tilt (HUT) testing with continuous beat-to-beat plethysmography. Our objective was to assess the accuracy of sit-stand testing with semi-automatic sphygmomanometry for the diagnosis of OH. DESIGN: Retrospective test of diagnostic accuracy. METHODS: This was a retrospective study performed using a database maintained by a busy syncope unit. HUT testing was performed using an automated tilt table with Finometer monitoring. A 3 min 70 degrees HUT was performed following 5 min supine. Sitting blood pressure (BP) was measured following 3 min rest. Standing BP was measured within 30 s of assuming the upright posture. The results of sit-stand testing were compared with HUT testing as a reference standard. Both tests happened within 5 min of each other and patients underwent no intervention between tests. RESULTS: From a total of 1452 consecutive HUTs, we identified 730 with pre-test measures of sitting and standing BP. The mean age of this group was 70.57 years (SD = 15.1), 62% were female. The sensitivity of sit-stand testing was calculated as 15.5%, specificity as 89.9%, positive predictive value as 61.7%, negative predictive value as 50.2% and the likelihood ratio as 1.6. The area under the Receiver Operator Curve was 0.564. CONCLUSION: We have demonstrated that sit-stand testing for OH has very low diagnostic accuracy. We recommend that the more time-consuming reference standard method of diagnosis be used if the condition is suspected.

Elm Green Nursing Home, New Dunsink Lane, Castleknock, Dublin 15.

LENUS (Irish Health Repository)

Cooke, J

2012-01-31

INTRODUCTION: Orthostatic hypotension (OH) is associated with troublesome symptoms and increased mortality. It is treatable and deserving of accurate diagnosis. This can be time consuming. The current reference standard for its diagnosis is head-up tilt (HUT) testing with continuous beat-to-beat plethysmography. Our objective was to assess the accuracy of sit-stand testing with semi-automatic sphygmomanometry for the diagnosis of OH. DESIGN: Retrospective test of diagnostic accuracy. METHODS: This was a retrospective study performed using a database maintained by a busy syncope unit. HUT testing was performed using an automated tilt table with Finometer monitoring. A 3 min 70 degrees HUT was performed following 5 min supine. Sitting blood pressure (BP) was measured following 3 min rest. Standing BP was measured within 30 s of assuming the upright posture. The results of sit-stand testing were compared with HUT testing as a reference standard. Both tests happened within 5 min of each other and patients underwent no intervention between tests. RESULTS: From a total of 1452 consecutive HUTs, we identified 730 with pre-test measures of sitting and standing BP. The mean age of this group was 70.57 years (SD = 15.1), 62% were female. The sensitivity of sit-stand testing was calculated as 15.5%, specificity as 89.9%, positive predictive value as 61.7%, negative predictive value as 50.2% and the likelihood ratio as 1.6. The area under the Receiver Operator Curve was 0.564. CONCLUSION: We have demonstrated that sit-stand testing for OH has very low diagnostic accuracy. We recommend that the more time-consuming reference standard method of diagnosis be used if the condition is suspected.

Determining airborne concentrations of spatial repellent chemicals in mosquito behavior assay systems.

Directory of Open Access Journals (Sweden)

Nicholas J Martin

Full Text Available BACKGROUND: Mosquito behavior assays have been used to evaluate the efficacy of vector control interventions to include spatial repellents (SR. Current analytical methods are not optimized to determine short duration concentrations of SR active ingredients (AI in air spaces during entomological evaluations. The aim of this study was to expand on our previous research to further validate a novel air sampling method to detect and quantitate airborne concentrations of a SR under laboratory and field conditions. METHODOLOGY/PRINCIPAL FINDINGS: A thermal desorption (TD gas chromatography-mass spectrometry (GC-MS method was used to determine the amount of dichlorodiphenyltrichloroethane (DDT in samples of air. During laboratory experiments, 1 L volumes of air were collected over 10 min intervals from a three-chamber mosquito behavior assay system. Significantly higher levels of airborne DDT were measured in the chamber containing textiles treated with DDT compared to chambers free of AI. In the field, 57 samples of air were collected from experimental huts with and without DDT for onsite analysis. Airborne DDT was detected in samples collected from treated huts. The mean DDT air concentrations in these two huts over a period of four days with variable ambient temperature were 0.74 µg/m(3 (n = 17; SD = 0.45 and 1.42 µg/m(3 (n = 30; SD = 0.96. CONCLUSIONS/SIGNIFICANCE: The results from laboratory experiments confirmed that significantly different DDT exposure conditions existed in the three-chamber system establishing a chemical gradient to evaluate mosquito deterrency. The TD GC-MS method addresses a need to measure short-term (<1 h SR concentrations in small volume (<100 L samples of air and should be considered for standard evaluation of airborne AI levels in mosquito behavior assay systems. Future studies include the use of TD GC-MS to measure other semi-volatile vector control compounds.

Mouse-resistant insulated covers keep pipes from freezing

Energy Technology Data Exchange (ETDEWEB)

Anon.

2010-01-15

Fabric wellhead covers and insulated blankets are commonly used at well sites in the Wyoming coalbed methane field to keep surface pipes from freezing. These materials are often chewed up by mice who build nests close to the warm pipes. The mice attract rattlesnakes, a potentially serious problem for the workmen who check the wells daily. Kennon Products of Sheridan, Wyoming solved this problem by making a flexible covering material that has a coating of hardened guard plates that prevents mice from chewing through it. More than a hundred of Kennon's mouse-resistant wellhead covers have been used successfully in the gas fields for over a year. They can be installed in less than 30 minutes and cost only a fraction of what a fiberglass hut costs to purchase and install. Huts are being discouraged for use on federal lands because they alter the nesting patterns of eagles, who perch upon them to hunt rodents. Huts also trap methane gas, which is a potential safety hazard. Kennon's mouse-resistant wellhead covers are lower than the fiberglass huts and blend into the landscape. The company is working on camouflage colours to make wellheads less noticeable. In the future, the company plans to insulate water pipes. 1 fig.

An Evaluation of Interference Mitigation Schemes for HAPS Systems

Directory of Open Access Journals (Sweden)

Nam Kim

2008-07-01

Full Text Available The International Telecommunication Union-Radiocommunication sector (ITU-R has conducted frequency sharing studies between fixed services (FSs using a high altitude platform station (HAPS and fixed-satellite services (FSSs. In particular, ITU-R has investigated the power limitations related to HAPS user terminals (HUTs to facilitate frequency sharing with space station receivers. To reduce the level of interference from the HUTs that can harm a geostationary earth orbit (GEO satellite receiver in a space station, previous studies have taken two approaches: frequency sharing using a separated distance (FSSD and frequency sharing using power control (FSPC. In this paper, various performance evaluation results of interference mitigation schemes are presented. The results include performance evaluations using a new interference mitigation approach as well as conventional approaches. An adaptive beamforming scheme (ABS is introduced as a new scheme for efficient frequency sharing, and the interference mitigation effect on the ABS is examined considering pointing mismatch errors. The results confirm that the application of ABS enables frequency sharing between two systems with a smaller power reduction of HUTs in a cocoverage area compared to this reduction when conventional schemes are utilized. In addition, the analysis results provide the proper amount of modification at the transmitting power level of the HUT required for the suitable frequency sharing.

Clinical Trials

Medline Plus

Full Text Available ... Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial ... clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical trial's protocol describes what ...

Islamist Distortions: Hizb ut- Tahrir a Breeding Ground for Al- Qaida Recruitment

Directory of Open Access Journals (Sweden)

Krishna Mungur

2009-01-01

Full Text Available In 1953, a radical splinter organization from the Muslim Brotherhood,Hizb ut-Tahrir (HuT, was founded by the Al-Azhar University (Cairo,Egypt educated jurist Sheikh Taqiuddin an-Nabhani who criticized theMuslim Brotherhood for collaborating with Egyptian secularists, such as Gamal Abdel Nasser. A sizable portion of the more radical members of the Muslim Brotherhood broke away, to join Nabhani's budding movement. Today, HuT is known to operate in more than forty countries, calling for the restoration of the Islamic Caliphate, with a history of violence and links to violent terrorist organizations. Given increasing tensions in the region over the presence of coalition troops, Predator drone airstrikes, a destabilized Pakistan, and lawless regions in Afghanistan, HuT is well positioned to amplify the strategic threat to coalition forces serving in the Pakistan and Afghanistan theaters.

Experimental Implementation of a Passive Millimeter-Wave Fast Sequential Lobing Radiometric Seeker Sensor

Directory of Open Access Journals (Sweden)

Massimiliano Rossi

2018-01-01

Full Text Available The paper investigates the theory of operation of a passive millimeter-wave seeker sensor using a fast electronic sequential-lobing technique and the experimental validation obtained through laboratory trials. The paper analyzes in detail the theoretical performance of a difference channel sensor and a pseudo-monopulse sensor deriving agile formulas for the estimation of target angular tracking accuracy and the subsequent experimental validation.

Clinical trial participation. Viewpoints from racial/ethnic groups.

Science.gov (United States)

Roberson, N L

1994-11-01

Racial/ethnic groups' participation in clinical trials is a relatively new area of research that warrants attention. Although racial/ethnic groups have been included in experimental studies since the 1940s, they were not included in significant numbers in clinical trials for cancer. Clinical trials play a dominant role in clinical oncology. Despite this state-of-the-art cancer treatment, however, there is mounting concern that this scientific progress is not being shared equitably by all segments of the U.S. population. There is underrepresentation of members of racial/ethnic groups in cancer clinical trials, which suggests that participation may be a critical issue. Unfortunately, little is known or documented about these groups' participation in clinical trials. This paper discusses racial/ethnic groups' views and opinions about clinical trial participation. Diagnostic research was conducted as a beginning phase to investigate this new area of research. African Americans, Hispanics, and Native Americans in three Buffalo, New York, communities were selected as study subjects. Data were collected via telephone surveys. Qualitative methods were employed for data analysis and reporting. Findings showed that study subjects knew little about cancer clinical trials and basically had no opportunity to participate. They believed that participation in clinical trials could be beneficial. In each of the three groups, however, there were cultural factors believed to influence participation. A primary concern was "mistrust of white people" and the feeling of being treated like "guinea pigs." Based on study findings, it was evident that recruitment for improving participation requires strategic planning that involves participants representative of the study population. To yield results, the plan should be tailored to the target group, presented as a credible study, designed to reflect trust in the medical care team, and implemented through a continuous educational process.

76 FR 81991 - National Spectrum Sharing Research Experimentation, Validation, Verification, Demonstration and...

Science.gov (United States)

2011-12-29

... NATIONAL SCIENCE FOUNDATION National Spectrum Sharing Research Experimentation, Validation... requirements of national level spectrum research, development, demonstration, and field trial facilities... to determine the optimal way to manage and use the radio spectrum. During Workshop I held at Boulder...

Study design issues in trials among children with MAM

International Nuclear Information System (INIS)

Friis, Henrik

2014-01-01

There is a need for acceptable and affordable food aid products for children with moderate acute malnutrition (MAM), which effectively restore body tissues and functions. The effects of potential products need to be assessed through randomised controlled trials (RCT). However, nutritional RCTs pose ethical and scientific challenges. Control groups are usually given “standard of care”, but recommendations for treatment do not exist in all settings or supplements are not always available. In places where treatment is nonexistent, not giving any food to children in the control group is not without ethical concerns. However, from public health and scientific perspectives, it is problematic to compare with supplements which are not recommended or the effect of which is unknown. Firstly, it is of questionable value for a low-income country that a trial is conducted to compare an experimental supplement to a supplement that is not already standard of care, and national ethics committees may not grant permission for such a trial. Secondly, it is difficult to interpret findings from a trial comparing an experimental supplement to one that has not been properly tested. Hence, where supplementation is not standard of care, it may be ethically justifiable to have an unsupplemented control group. In such cases, mothers should receive health education and the children should receive medical attention, be monitored closely, and referred for further medical examination and treatment if not recovering. Delayed supplementation may also be considered. Food interventions are complex, since supplements with the same energy content may be based on different ingredients, and nutrients in different forms and amounts. Consequently, there are an infinite number of potential food supplements, yet only a few can be tested in trials. Some components may be potentially important, but costly. If several factors are of interest, then a factorial design may be needed. E.g. the treatFOOD trial

Symposium on the Tropospheric Chemistry of the Antarctic Region: Pre- Conference Abstracts

Science.gov (United States)

1991-06-01

sampling stack, Pollak counter, ozone meter, recording system in aurora hut, Old Pole Station, 1974. 15 OZONE CONCENTRATION AND MICROMETEOROLOGICAL...and no evident relation with the sediments of four small lakes collected in the area. Aurora hut and balloon inflation shelter, as seen from the head... Amazon ). Results from this work accord with those in the first one. A discussion will be made on how tracers from the NH are transported into the SH

Clinical Trials

Medline Plus

Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

Together We STRIDE: A quasi-experimental trial testing the effectiveness of a multi-level obesity intervention for Hispanic children in rural communities.

Science.gov (United States)

Ko, Linda K; Rillamas-Sun, Eileen; Bishop, Sonia; Cisneros, Oralia; Holte, Sarah; Thompson, Beti

2018-04-01

Hispanic children are disproportionally overweight and obese compared to their non-Hispanic white counterparts in the US. Community-wide, multi-level interventions have been successful to promote healthier nutrition, increased physical activity (PA), and weight loss. Using community-based participatory approach (CBPR) that engages community members in rural Hispanic communities is a promising way to promote behavior change, and ultimately weight loss among Hispanic children. Led by a community-academic partnership, the Together We STRIDE (Strategizing Together Relevant Interventions for Diet and Exercise) aims to test the effectiveness of a community-wide, multi-level intervention to promote healthier diets, increased PA, and weight loss among Hispanic children. The Together We STRIDE is a parallel quasi-experimental trial with a goal of recruiting 900 children aged 8-12 years nested within two communities (one intervention and one comparison). Children will be recruited from their respective elementary schools. Components of the 2-year multi-level intervention include comic books (individual-level), multi-generational nutrition and PA classes (family-level), teacher-led PA breaks and media literacy education (school-level), family nights, a farmer's market and a community PA event (known as ciclovia) at the community-level. Children from the comparison community will receive two newsletters. Height and weight measures will be collected from children in both communities at three time points (baseline, 6-months, and 18-months). The Together We STRIDE study aims to promote healthier diet and increased PA to produce healthy weight among Hispanic children. The use of CBPR approach and the engagement of the community will springboard strategies for intervention' sustainability. Clinical Trials Registration Number: NCT02982759 Retrospectively registered. Copyright © 2018 Elsevier Inc. All rights reserved.

NUCLEAR HEATING IN LIF DOSEMETERS IN A FUSION NEUTRON FIELD, TRIAL OF DIRECT COMPARISON OF EXPERIMENTAL AND SIMULATED RESULTS.

Science.gov (United States)

Pohorecki, Wladyslaw; Obryk, Barbara

2017-09-29

The results of nuclear heating measured by means of thermoluminescent dosemeters (TLD-LiF) in a Cu block irradiated by 14 MeV neutrons are presented. The integral Cu experiment relevant for verification of copper nuclear data at neutron energies characteristic for fusion facilities was performed in the ENEA FNG Laboratory at Frascati. Five types of TLDs were used: highly photon sensitive LiF:Mg,Cu,P (MCP-N), 7LiF:Mg,Cu,P (MCP-7) and standard, lower sensitivity LiF:Mg,Ti (MTS-N), 7LiF:Mg,Ti (MTS-7) and 6LiF:Mg,Ti (MTS-6). Calibration of the detectors was performed with gamma rays in terms of air-kerma (10 mGy of 137Cs air-kerma). Nuclear heating in the Cu block was also calculated with the use of MCNP transport code Nuclear heating in Cu and air in TLD's positions was calculated as well. The nuclear heating contribution from all simulated by MCNP6 code particles including protons, deuterons, alphas tritons and heavier ions produced by the neutron interactions were calculated. A trial of the direct comparison between experimental results and results of simulation was performed. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Clinical and experimental applications of sodium phenylbutyrate.

Science.gov (United States)

Iannitti, Tommaso; Palmieri, Beniamino

2011-09-01

Histone acetyltransferase and histone deacetylase are enzymes responsible for histone acetylation and deacetylation, respectively, in which the histones are acetylated and deacetylated on lysine residues in the N-terminal tail and on the surface of the nucleosome core. These processes are considered the most important epigenetic mechanisms for remodeling the chromatin structure and controlling the gene expression. Histone acetylation is associated with gene activation. Sodium phenylbutyrate is a histone deacetylase inhibitor that has been approved for treatement of urea cycle disorders and is under investigation in cancer, hemoglobinopathies, motor neuron diseases, and cystic fibrosis clinical trials. Due to its characteristics, not only of histone deacetylase inhibitor, but also of ammonia sink and chemical chaperone, the interest towards this molecule is growing worldwide. This review aims to update the current literature, involving the use of sodium phenylbutyrate in experimental studies and clinical trials.

The use of placebo control in clinical trials: An overview of the ...

African Journals Online (AJOL)

The use of placebo control in clinical trials: An overview of the ethical issues involved for the protection of human research participants. ... A placebo looks exactly like the experimental drugs in every respect both in appearance and wrappings ...

Development of a cancer clinical trials multi-media intervention: clinical trials: are they right for you?

Science.gov (United States)

Wells, Kristen J; Quinn, Gwendolyn P; Meade, Cathy D; Fletcher, Michelle; Tyson, Dinorah Martinez; Jim, Heather; Jacobsen, Paul B

2012-08-01

To describe processes used to develop a multi-media psycho-educational intervention to prepare patients for a discussion about cancer clinical trials (CTs). Guided by a Steering Committee, formative research was conducted to develop an informative and engaging tool about cancer CTs. Twenty-three patients and caregivers participated in formative in-depth interviews to elicit information about perceptions of cancer CTs to inform production of a new media product. Formative research revealed participants had concerns about experimentation, held beliefs that cancer CTs were for patients who had no other treatment options, and wanted a balance of information about pros and cons of CT participation. The value of physicians as credible spokespersons and the use of patients as role-models were supported. Using iterative processes, the production team infused the results into creation of a multimedia psycho-educational intervention titled Clinical Trials: Are they Right for You? An intervention, developed through an iterative consumer-focused process involving multiple stakeholders and formative research, may result in an engaging informative product. If found to be efficacious, Clinical Trials: Are they Right for You? is a low-cost and easily disseminated multimedia psycho-educational intervention to assist cancer patients with making an informed decision about cancer CTs. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Effect of Acute Exposure to Hypergravity (Gx vs. Gz) on Dynamic Cerebral Autoregulation

Science.gov (United States)

Serrador, Jorge M.; Wood, S. J.; Picot, P. A.; Stein, F.; Kassam, M. S.; Bondar, R. L.; Rupert, A. H.; Schlegel, T. T.

2001-01-01

We examined the effects of 30 min of exposure to either +3G(sub x) or +3G(sub z) centrifugation on cerebrovascular responses to 800 head-up tilt (HUT) in 14 healthy individuals. Both before and after +3G(sub x) or +3G(sub z) centrifugation, eye-level blood pressure (BP(sub eye)), end tidal CO2 (P(sub ET)CO2), mean cerebral flow velocity (CFV) in the middle cerebral artery (trans cranial Doppler ultrasound), cerebral vascular resistance (CVR) and dynamic cerebral autoregulatory gain (GAIN) were measured with subjects in the supine position and during subsequent 800 HUT for 30 min. Mean BP(sub eye) decreased with HUT in both the G(sub x) (n= 7) and G(sub z) (n=7) groups (P less than 0.00l), with the decrease being greater after centrifugation only in the G(sub z) group (P less than 0.05). P(sub ET)CO2 also decreased with HUT in both groups (P less than 0.0l), but the absolute level of decrease was unaffected by centrifugation. CFV decreased during HUT more significantly after than before centrifugation in both groups (P less than 0.02). However, these greater decreases were not associated with greater increases in CVR. In the supine position after compared to before centrifugation, GAIN increased in both groups (P less than 0.05, suggesting an autoregulatory deficit), with the change being correlated to a measure of otolith function (the linear vestibulo-ocular reflex) in the G(sub x) group (R=0.76, P less than 0.05) but not in the G(sub z) group (R=0.24, P=0.60). However, GAIN was subsequently restored to pre-centrifugation levels during post-centrifugation HUT (i.e., as BP(sub eye) decreased), suggesting that both types of centrifugation resulted in a leftward shift of the cerebral autoregulation curve. We speculate that this leftward shift may have been due to vestibular activation (especially during +G(sub x)) or potentially to an adaptation to reduced cerebral perfusion pressure during +G(sub z).

Understanding cognitive processes behind acceptance or refusal of phase I trials.

Science.gov (United States)

Pravettoni, Gabriella; Mazzocco, Ketti; Gorini, Alessandra; Curigliano, Giuseppe

2016-04-01

Participation in phase I trials gives patients the chance to obtain control over their disease by trying an experimental therapy. The patients' vulnerability, the informed consent process aiming at understanding the purpose and potential benefits of the phase I trial, and the complexity of the studies may impact the patient's final decision. Emotionally difficult health conditions may induce patients to succumb to cognitive biases, allocating attention only on a part of the provided information. Filling the gap in patients' information process can foster the implementation of strategies to help physicians tailor clinical trials' communication providing personalized support and tailored medical information around patients' need, so avoiding cognitive biases in patients and improving informed shared decision quality. The aim of the present review article focuses on the analysis of cognitive and psychological factors that affect patients' decision to participate or not to early phase clinical trials. Copyright © 2016. Published by Elsevier Ireland Ltd.

Quantifying behavioural interactions between humans and mosquitoes: Evaluating the protective efficacy of insecticidal nets against malaria transmission in rural Tanzania

Directory of Open Access Journals (Sweden)

Mathenge Evan

2006-11-01

Full Text Available Abstract Background African malaria vectors bite predominantly indoors at night so sleeping under an Insecticide-Treated Net (ITN can greatly reduce malaria risk. Behavioural adaptation by mosquitoes to increasing ITN coverage could allow vector mosquitoes to bite outside of peak sleeping hours and undermine efficacy of this key malaria prevention measure. Methods High coverage with largely untreated nets has been achieved in the Kilombero Valley, southern Tanzania through social marketing programmes. Direct surveys of nightly biting activity by An. gambiae Giles were conducted in the area before (1997 and after (2004 implementation of ITN promotion. A novel analytical model was applied to estimate the effective protection provided by an ITN, based on published experimental hut trials combined with questionnaire surveys of human sleeping behaviour and recorded mosquito biting patterns. Results An. gambiae was predominantly endophagic and nocturnal in both surveys: Approximately 90% and 80% of exposure occurred indoors and during peak sleeping hours, respectively. ITNs consistently conferred >70% protection against exposure to malaria transmission for users relative to non-users. Conclusion As ITN coverage increases, behavioural adaptation by mosquitoes remains a future possibility. The approach described allows comparison of mosquito biting patterns and ITN efficacy at multiple study sites and times. Initial results indicate ITNs remain highly effective and should remain a top-priority intervention. Combined with recently developed transmission models, this approach allows rapid, informative and cost-effective preliminary comparison of diverse control strategies in terms of protection against exposure before more costly and intensive clinical trials.

Does the StartReact Effect Apply to First-Trial Reactive Movements?

Directory of Open Access Journals (Sweden)

Katrin Sutter

Full Text Available StartReact is the acceleration of reaction time by a startling acoustic stimulus (SAS. The SAS is thought to release a pre-prepared motor program. Here, we investigated whether the StartReact effect is applicable to the very first trial in a series of repeated unpractised single-joint movements.Twenty healthy young subjects were instructed to perform a rapid ankle dorsiflexion movement in response to an imperative stimulus. Participants were divided in two groups of ten. Both groups performed 17 trials. In one group a SAS (116 dB was given in the first trial, whereas the other group received a non-startling sound (70 dB as the first imperative stimulus. In the remaining 16 trials, the SAS was given as the imperative stimulus in 25% of the trials in both groups. The same measurement was repeated one week later, but with the first-trial stimuli counterbalanced between groups.When a SAS was given in the very first trial, participants had significantly shorter onset latencies compared to first-trial responses to a non-startling stimulus. Succeeding trials were significantly faster compared to the first trial, both for trials with and without a SAS. However, the difference between the first and succeeding trials was significantly larger for responses to a non-startling stimulus compared to responses triggered by a SAS. SAS-induced acceleration in the first trial of the second session was similar to that in succeeding trials of session 1.The present results confirm that the StartReact phenomenon also applies to movements that have not yet been practiced in the experimental context. The excessive SAS-induced acceleration in the very first trial may be due to the absence of integration of novel context-specific information with the existing motor memory for movement execution. Our findings demonstrate that StartReact enables a rapid release of motor programs in the very first trial also without previous practice, which might provide a behavioural

Experimental Evaluation of Instructional Consultation Teams on Teacher Beliefs and Practices

Science.gov (United States)

Vu, Phuong; Shanahan, Katherine Bruckman; Rosenfield, Sylvia; Gravois, Todd; Koehler, Jessica; Kaiser, Lauren; Berger, Jill; Vaganek, Megan; Gottfredson, Gary D.; Nelson, Deborah

2013-01-01

Instructional Consultation Teams (IC Teams) are an early intervention service intended to support teachers in working with struggling students. This is a large-scale experimental trial investigating the effects of IC Teams on teacher efficacy, instructional practices, collaboration, and job satisfaction. Public elementary schools (N = 34) were…

Low Latitude Aeronomy Study in Africa

Science.gov (United States)

2016-02-09

was acquired and an aluminum base plate was attached to the optical dome for mounting on the top of the house for the instrument. The dome was...Preparation in Ivory Coast NCAR also worked closely with our Ivory Coast colleagues to make the necessary preparation for the site. An optical dome ...constructed a new hut to house the FPI with their funding (Figure 2). Figure 2. The hut (under construction earlier in 2015) in Korhogo Ivory

Market Trials of Irradiated Spices

International Nuclear Information System (INIS)

Charoen, Saovapong; Eemsiri, Jaruratana; Sajjabut, Surasak

2009-07-01

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

Some manufacture and installation problems in experimental assemblies for fusion research

International Nuclear Information System (INIS)

Partridge, J.E.; Rappe, G.; Hoare, F.; McDonald, J.

1976-01-01

Many of the manufacturing problems encountered when developing specialised items of fusion apparatus are only solved after much experimentation and a good deal of trial and error. After the experiment is built such problems may be forgotten and are often not recorded so that subsequent workers in the same field may start with no past experience on which to build. The paper therefore highlights some of the manufacturing problems which have been solved during the construction of some of the experimental apparatus at Culham

The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema

DEFF Research Database (Denmark)

Ibler, Kristina Sophie; Agner, Tove; Hansen, Jane L.

2010-01-01

. The experimental group undergoes patch and prick testing; classification of the hand eczema; demonstration of hand washing and appliance of emollients; individual counselling, and a skin-care programme. The control group receives no intervention. All participants are reassessed after six months. The primary...... strategies are needed to reduce occupational hand eczema. METHODS/DESIGN: We describe the design of a randomised clinical trial to investigate the effects of classification of hand eczema plus individual counselling versus no intervention. The trial includes health-care workers with hand eczema identified...

A Global Remote Laboratory Experimentation Network and the Experiment Service Provider Business Model and Plans

Directory of Open Access Journals (Sweden)

Tor Ivar Eikaas

2003-07-01

Full Text Available This paper presents results from the IST KAII Trial project ReLAX - Remote LAboratory eXperimentation trial (IST 1999-20827, and contributes with a framework for a global remote laboratory experimentation network supported by a new business model. The paper presents this new Experiment Service Provider business model that aims at bringing physical experimentation back into the learning arena, where remotely operable laboratory experiments used in advanced education and training schemes are made available to a global education and training market in industry and academia. The business model is based on an approach where individual experiment owners offer remote access to their high-quality laboratory facilities to users around the world. The usage can be for research, education, on-the-job training etc. The access to these facilities is offered via an independent operating company - the Experiment Service Provider. The Experiment Service Provider offers eCommerce services like booking, access control, invoicing, dispute resolution, quality control, customer evaluation services and a unified Lab Portal.

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

Science.gov (United States)

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

2014-01-01

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

Adaptive Clinical Trials: Advantages and Disadvantages of Various Adaptive Design Elements.

Science.gov (United States)

Korn, Edward L; Freidlin, Boris

2017-06-01

There is a wide range of adaptive elements of clinical trial design (some old and some new), with differing advantages and disadvantages. Classical interim monitoring, which adapts the design based on early evidence of superiority or futility of a treatment arm, has long been known to be extremely useful. A more recent application of interim monitoring is in the use of phase II/III designs, which can be very effective (especially in the setting of multiple experimental treatments and a reliable intermediate end point) but do have the cost of having to commit earlier to the phase III question than if separate phase II and phase III trials were performed. Outcome-adaptive randomization is an older technique that has recently regained attention; it increases trial complexity and duration without offering substantial benefits to the patients in the trial. The use of adaptive trials with biomarkers is new and has great potential for efficiently identifying patients who will be helped most by specific treatments. Master protocols in which trial arms and treatment questions are added to an ongoing trial can be especially efficient in the biomarker setting, where patients are screened for entry into different subtrials based on evolving knowledge about targeted therapies. A discussion of three recent adaptive clinical trials (BATTLE-2, I-SPY 2, and FOCUS4) highlights the issues. Published by Oxford University Press 2017. This work is written by US Government employees and is in the public domain in the US.

Big Data Mining and Adverse Event Pattern Analysis in Clinical Drug Trials.

Science.gov (United States)

Federer, Callie; Yoo, Minjae; Tan, Aik Choon

2016-12-01

Drug adverse events (AEs) are a major health threat to patients seeking medical treatment and a significant barrier in drug discovery and development. AEs are now required to be submitted during clinical trials and can be extracted from ClinicalTrials.gov ( https://clinicaltrials.gov/ ), a database of clinical studies around the world. By extracting drug and AE information from ClinicalTrials.gov and structuring it into a database, drug-AEs could be established for future drug development and repositioning. To our knowledge, current AE databases contain mainly U.S. Food and Drug Administration (FDA)-approved drugs. However, our database contains both FDA-approved and experimental compounds extracted from ClinicalTrials.gov . Our database contains 8,161 clinical trials of 3,102,675 patients and 713,103 reported AEs. We extracted the information from ClinicalTrials.gov using a set of python scripts, and then used regular expressions and a drug dictionary to process and structure relevant information into a relational database. We performed data mining and pattern analysis of drug-AEs in our database. Our database can serve as a tool to assist researchers to discover drug-AE relationships for developing, repositioning, and repurposing drugs.

Nonresponse bias in randomized controlled experiments in criminology: Putting the Queensland Community Engagement Trial (QCET) under a microscope.

Science.gov (United States)

Antrobus, Emma; Elffers, Henk; White, Gentry; Mazerolle, Lorraine

2013-01-01

The goal of this article is to examine whether or not the results of the Queensland Community Engagement Trial (QCET)-a randomized controlled trial that tested the impact of procedural justice policing on citizen attitudes toward police-were affected by different types of nonresponse bias. We use two methods (Cochrane and Elffers methods) to explore nonresponse bias: First, we assess the impact of the low response rate by examining the effects of nonresponse group differences between the experimental and control conditions and pooled variance under different scenarios. Second, we assess the degree to which item response rates are influenced by the control and experimental conditions. Our analysis of the QCET data suggests that our substantive findings are not influenced by the low response rate in the trial. The results are robust even under extreme conditions, and statistical significance of the results would only be compromised in cases where the pooled variance was much larger for the nonresponse group and the difference between experimental and control conditions was greatly diminished. We also find that there were no biases in the item response rates across the experimental and control conditions. RCTs that involve field survey responses-like QCET-are potentially compromised by low response rates and how item response rates might be influenced by the control or experimental conditions. Our results show that the QCET results were not sensitive to the overall low response rate across the experimental and control conditions and the item response rates were not significantly different across the experimental and control groups. Overall, our analysis suggests that the results of QCET are robust and any biases in the survey responses do not significantly influence the main experimental findings.

Combinatorial control of adhesion of Brucella abortus 2308 to host cells by transcriptional rewiring of the trimeric autotransporter btaE gene.

Science.gov (United States)

Sieira, Rodrigo; Bialer, Magalí G; Roset, Mara S; Ruiz-Ranwez, Verónica; Langer, Tomás; Arocena, Gastón M; Mancini, Estefanía; Zorreguieta, Angeles

2017-02-01

Regulatory network plasticity is a key attribute underlying changes in bacterial gene expression and a source of phenotypic diversity to interact with the surrounding environment. Here, we sought to study the transcriptional circuit of HutC, a regulator of both metabolic and virulence genes of the facultative intracellular pathogen Brucella. Using in silico and biochemical approaches, we identified a novel functional HutC-binding site upstream of btaE, a trimeric-autotransporter adhesin involved in the attachment of Brucella to host extracellular matrix components. Moreover, we identified two additional regulators, one of which, MdrA, acts in concert with HutC to exert a combinatorial control of both btaE promoter activity and attachment of Brucella to HeLa cells. Analysis of btaE promoter sequences of different species indicated that this HutC-binding site was generated de novo by a single point mutation in a virulent Brucella strain, indicative of a transcriptional rewiring event. In addition to major domain organization differences existing between BtaE proteins within the genus Brucella, our analyses revealed that sequences upstream of btaE display high variability probably associated to intrinsic promoter structural features, which may serve as a substrate for reciprocal selection during co-evolution between this pathogen and its mammalian host. © 2016 John Wiley & Sons Ltd.

An Evaluation of Interference Mitigation Schemes for HAPS Systems

Directory of Open Access Journals (Sweden)

Kim Nam

2008-01-01

Full Text Available Abstract The International Telecommunication Union-Radiocommunication sector (ITU-R has conducted frequency sharing studies between fixed services (FSs using a high altitude platform station (HAPS and fixed-satellite services (FSSs. In particular, ITU-R has investigated the power limitations related to HAPS user terminals (HUTs to facilitate frequency sharing with space station receivers. To reduce the level of interference from the HUTs that can harm a geostationary earth orbit (GEO satellite receiver in a space station, previous studies have taken two approaches: frequency sharing using a separated distance (FSSD and frequency sharing using power control (FSPC. In this paper, various performance evaluation results of interference mitigation schemes are presented. The results include performance evaluations using a new interference mitigation approach as well as conventional approaches. An adaptive beamforming scheme (ABS is introduced as a new scheme for efficient frequency sharing, and the interference mitigation effect on the ABS is examined considering pointing mismatch errors. The results confirm that the application of ABS enables frequency sharing between two systems with a smaller power reduction of HUTs in a cocoverage area compared to this reduction when conventional schemes are utilized. In addition, the analysis results provide the proper amount of modification at the transmitting power level of the HUT required for the suitable frequency sharing.

Defining standardized protocols for determining the efficacy of a postmilking teat disinfectant following experimental exposure of teats to mastitis pathogens.

Science.gov (United States)

Schukken, Y H; Rauch, B J; Morelli, J

2013-04-01

The objective of this paper was to define standardized protocols for determining the efficacy of a postmilking teat disinfectant following experimental exposure of teats to both Staphylococcus aureus and Streptococcus agalactiae. The standardized protocols describe the selection of cows and herds and define the critical points in performing experimental exposure, performing bacterial culture, evaluating the culture results, and finally performing statistical analyses and reporting of the results. The protocols define both negative control and positive control trials. For negative control trials, the protocol states that an efficacy of reducing new intramammary infections (IMI) of at least 40% is required for a teat disinfectant to be considered effective. For positive control trials, noninferiority to a control disinfectant with a published efficacy of reducing new IMI of at least 70% is required. Sample sizes for both negative and positive control trials are calculated. Positive control trials are expected to require a large trial size. Statistical analysis methods are defined and, in the proposed methods, the rate of IMI may be analyzed using generalized linear mixed models. The efficacy of the test product can be evaluated while controlling for important covariates and confounders in the trial. Finally, standards for reporting are defined and reporting considerations are discussed. The use of the defined protocol is shown through presentation of the results of a recent trial of a test product against a negative control. Copyright © 2013 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Two biomarker-directed randomized trials in European and Chinese patients with nonsmall-cell lung cancer: the BRCA1-RAP80 Expression Customization (BREC) studies.

Science.gov (United States)

Moran, T; Wei, J; Cobo, M; Qian, X; Domine, M; Zou, Z; Bover, I; Wang, L; Provencio, M; Yu, L; Chaib, I; You, C; Massuti, B; Song, Y; Vergnenegre, A; Lu, H; Lopez-Vivanco, G; Hu, W; Robinet, G; Yan, J; Insa, A; Xu, X; Majem, M; Chen, X; de Las Peñas, R; Karachaliou, N; Sala, M A; Wu, Q; Isla, D; Zhou, Y; Baize, N; Zhang, F; Garde, J; Germonpre, P; Rauh, S; ALHusaini, H; Sanchez-Ronco, M; Drozdowskyj, A; Sanchez, J J; Camps, C; Liu, B; Rosell, R

2014-11-01

In a Spanish Lung Cancer Group (SLCG) phase II trial, the combination of BRCA1 and receptor-associated protein 80 (RAP80) expression was significantly associated with outcome in Caucasian patients with nonsmall-cell lung cancer (NSCLC). The SLCG therefore undertook an industry-independent collaborative randomized phase III trial comparing nonselected cisplatin-based chemotherapy with therapy customized according to BRCA1/RAP80 expression. An analogous randomized phase II trial was carried out in China under the auspices of the SLCG to evaluate the effect of BRCA1/RAP80 expression in Asian patients. Eligibility criteria included stage IIIB-IV NSCLC and sufficient tumor specimen for molecular analysis. Randomization to the control or experimental arm was 1 : 1 in the SLCG trial and 1 : 3 in the Chinese trial. In both trials, patients in the control arm received docetaxel/cisplatin; in the experimental arm, patients with low RAP80 expression received gemcitabine/cisplatin, those with intermediate/high RAP80 expression and low/intermediate BRCA1 expression received docetaxel/cisplatin, and those with intermediate/high RAP80 expression and high BRCA1 expression received docetaxel alone. The primary end point was progression-free survival (PFS). Two hundred and seventy-nine patients in the SLCG trial and 124 in the Chinese trial were assessable for PFS. PFS in the control and experimental arms in the SLCG trial was 5.49 and 4.38 months, respectively [log rank P = 0.07; hazard ratio (HR) 1.28; P = 0.03]. In the Chinese trial, PFS was 4.74 and 3.78 months, respectively (log rank P = 0.82; HR 0.95; P = 0.82). Accrual was prematurely closed on the SLCG trial due to the absence of clinical benefit in the experimental over the control arm. However, the BREC studies provide proof of concept that an international, nonindustry, biomarker-directed trial is feasible. Thanks to the groundwork laid by these studies, we expect that ongoing further research on alternative biomarkers to

Inattentional blindness on the full-attention trial: Are we throwing out the baby with the bathwater?

Science.gov (United States)

White, Rebekah C; Davies, Martin; Aimola Davies, Anne M

2018-03-01

When attention is otherwise engaged, observers may experience inattentional blindness, failing to notice objects or events that are presented in plain sight. In an inattentional blindness experiment, an unexpectedstimulus ispresented alongside primary-task stimuli, and its detection is probed. We evaluate a criterion that is commonly used to exclude observers from the data analysis. On the final experimental trial, observers do not perform the primary task, but instead look for anything new. Observers who fail to report the unexpected stimulus on thisfull-attention trialare excluded. On the basis of 4 hypothetical experiments and a review of 128 actual experiments from the literature, we demonstrate some potentially problematic consequences of implementing the full-attention-trial exclusion criterion. Excluded observers may cluster in experimental conditions and the exclusion criterion may lead researchers to understate the pervasiveness of inattentional blindness. It may even render usblindto inattentional blindness on the full-attention trial. Copyright © 2017 Elsevier Inc. All rights reserved.

Mixture-based gatekeeping procedures in adaptive clinical trials.

Science.gov (United States)

Kordzakhia, George; Dmitrienko, Alex; Ishida, Eiji

2018-01-01

Clinical trials with data-driven decision rules often pursue multiple clinical objectives such as the evaluation of several endpoints or several doses of an experimental treatment. These complex analysis strategies give rise to "multivariate" multiplicity problems with several components or sources of multiplicity. A general framework for defining gatekeeping procedures in clinical trials with adaptive multistage designs is proposed in this paper. The mixture method is applied to build a gatekeeping procedure at each stage and inferences at each decision point (interim or final analysis) are performed using the combination function approach. An advantage of utilizing the mixture method is that it enables powerful gatekeeping procedures applicable to a broad class of settings with complex logical relationships among the hypotheses of interest. Further, the combination function approach supports flexible data-driven decisions such as a decision to increase the sample size or remove a treatment arm. The paper concludes with a clinical trial example that illustrates the methodology by applying it to develop an adaptive two-stage design with a mixture-based gatekeeping procedure.

Clinical Trials

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Full Text Available ... take part in a clinical trial. When researchers think that a trial's potential risks are greater than ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

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Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

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Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are ... earlier than they would be in general medical practice. This is because late-phase trials have large ...

Clinical Trials

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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

Clinical Trials

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Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... will be done during the clinical trial and why. Each medical center that does the study uses ...

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Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ...

Small sarcocysts can be a feature of experimental infections with Sarcocystis neurona merozoites.

Science.gov (United States)

Marsh, Antoinette E; Chaney, Sarah B; Howe, Daniel K; Saville, William J; Reed, Stephen M

2017-10-15

Several reports indicate the presence of small tissue cysts associated with Sarcocystis neurona infections. Several failed attempts to develop tissue cysts in potential intermediate host using in vitro derived parasites originally isolated from horses with equine protozoal myeloencephalitis suggest that the experimental methods to achieve bradyzoites with those isolates was not possible. Those prior studies reported the lack of detectable sarcocysts based on histology and in vivo feeding trials. A recent report of successful production and detection of small sarcocysts triggered us to review archived tissues from earlier experimental infection studies. The retrospective review sought to determine if small sized sarcocysts were not detected due to their relatively smaller size and infrequency as compared to larger sized sarcocysts produced with other isolates in these experimental inoculation trials. Tissues from two prior in vivo inoculation studies, involving in vitro-produced parasites inoculated into laboratory-reared cats and raccoons, were re-examined by immunohistochemistry staining to more easily detect the tissue cysts. In the experimental cat study no small tissue cysts were seen, consistent with the original publication results. However, in the experimental raccoon study, one raccoon inoculated with an EPM-derived isolate, SN-UCD1, had small sarcocysts not reported in the original publication. This retrospective study suggests that much closer scrutiny of tissues, including the use of immunohistochemistry on tissue sections is required to detect the smaller S. neurona sarcocysts associated with the experimental inoculations of the isolates originally derived from horses with EPM. Published by Elsevier B.V.

The HERrespect intervention to address violence against female garment workers in Bangladesh: study protocol for a quasi-experimental trial.

Science.gov (United States)

Al Mamun, Mahfuz; Parvin, Kausar; Yu, Marat; Wan, Jessica; Willan, Samantha; Gibbs, Andrew; Jewkes, Rachel; Naved, Ruchira Tabassum

2018-04-18

Women in Bangladesh experience high rates of Intimate Partner Violence (IPV). IPV is more prevalent against income earning women compared to their non-earning counterparts, and Workplace Violence (WPV) is also common. Such violence is a violation of women's rights, and also constrains them from contributing to their personal growth, household, community and the economy at large. There is limited evidence on what works to prevent IPV and WPV amongst garment workers. This paper describes an evaluation of HERrespect, an intervention which aims to reduce IPV and WPV against female garment workers in and around Dhaka, Bangladesh. The trial employs a quasi-experimental design, with four intervention and four control factories. In the intervention factories a randomly selected cohort of married female line workers, a cohort of male line workers, and all middle management staff received the intervention. The intervention strategies involved (1) gender transformative group-based training for workers and management staff; (2) joint session between workers (15 female and male) and middle-management staff; (3) factory-wide activities; (4) awareness raising among top management; (5) factory policy review and development and 6) a community based campaign. For the evaluation, a cohort of randomly selected female workers and a cohort of selected management staff have been established. All workers (n = 800) and management staff (n = 395) from these cohorts were interviewed at baseline using two different questionnaires, and will be interviewed in the endline, 24 months post-baseline. Intention to treat analysis will be used for assessing the impact of HERrespect, comparing the intervention and control factories. To our knowledge this is the first study that seeks to evaluate the impact on IPV and WPV, of group sessions with female workers, male workers, and management; factory-wide campaigns and a community intervention among female garment workers in Bangladesh. Apart

Epitaxial clusters studied by synchrotron x-ray diffraction and scanning tunneling microscopy

DEFF Research Database (Denmark)

Nielsen, M.; Feidenhans'l, R.; Rasmussen, F.B.

1998-01-01

Nanoscale clusters are often formed during heteroepitaxial crystal growth. Misfit between the lattice parameter of the substrate and the adsorbate stimulates the formation of regular clusters with a characteristic size. The well-known "hut-clusters" formed during the growth of Ge on Si(001) are a...... similar to the "hut clusters". We demonstrate that X-ray diffraction in combination with scanning tunneling microscopy can be used to determine the fundamental properties of such clusters. (C) 1998 Elsevier Science B.V. All rights reserved....

Studies on development of experimental system for trial manufacture of semi-field scale lysimeter

International Nuclear Information System (INIS)

Kamada, Hiroshi; Yukawa, Masae; Watabe, Teruhisa; Tanaka, Hirobumi; Ohwaku, Keiichi

1978-01-01

Because of difficulties in conduct of in situ experiments using the radiotracer method for this purpose, it is necessary to develope the technique on utilization of the results obtained by the laboratory works to resolve phenomenon in the actual environment. For this kind of extrapolation, optimum size of experimental model, designed as large as reasonable in scale to simulate the actual environment (defined as the term, 'semi-field scale experimental model' for convenience) was investigated. For this kind of extrapolation, optimum size of experimental model, designed as large as reasonable in scale to simulate the actual environment (defined as the term, 'semi-field scale experimental model' for convenience) was investigated. For this object, following experiments are especially conducted. The effects of vegetation to the mobility of transition elements in the surface layer of soil was studied by Wagner pot experiment. The vertical movement pattern of radionuclides in the deeper layer in the ground, especially transfer of long-lived-nuclides from soil into water, was investigated using radioactivity survey data of fallout. These results indicated the importance of information on the behaviour of contaminants in 'surface soil', 'Intermediate zone', 'capillary zone' and 'aquifer'. Therefore, an experimental mode, consisted of above four parts, was designed. The apparatus would include several substructures; an artificial rainfall apparatus, the Lysimeter, and receptive basin and so on. A regulation system for the fluctuation of hydraulic gradient in the aquifer would be also required. In order to get information on the above four parts of ground constitutions altogether, approximately 4 - 12 m depth was recommended for the model. (author)

Height determination at the transfer unit in isotopic distillation of hydrogen on type B7 ordered column packing

International Nuclear Information System (INIS)

Pop, F.; Croitoru, C.; Peculea, M.

2001-01-01

Owing to the low pressure drop implied by ordered column packings these are often utilized for vacuum distillations and separation of mixtures in which the important component occurs at a very low concentration, as for instance is the case of water, deuterium or oxygen isotopic distillation. The paper presents a model for determination of the height of transfer unit (HTU) in the hydrogen isotopic distillation installation, equipped with ordered column packing of B7 type. The computed values for HUT based on the analogy between heat, moment and mass transfer, were compared with the experimental data

Remune trial will stop; new trials planned.

Science.gov (United States)

James, J S

1999-05-21

A clinical trial using remune, the anti-HIV vaccine developed by the late Dr. Jonas Salk, has been ended. The study is a clinical-endpoint trial which looks for statistically significant differences in AIDS sickness or death between patients who add remune to their treatment regimens versus those who use a placebo. Agouron Pharmaceuticals and the Immune Response Corporation who were conducting the trial announced their decision to stop it after an analysis by the Data Safety Monitoring Board. No differences in clinical endpoints were found and it was projected that continuing the trial would likely not find any. The companies are now planning two new Phase III trials using viral load testing rather than clinical endpoints as study criteria.

Intestinal colonization of broiler chickens by Campylobacter spp. in an experimental infection study

DEFF Research Database (Denmark)

Bahrndorff, Simon; Garcia Clavero, Ana Belén; Vigre, Håkan

2015-01-01

Consumption of poultry meat is considered as one of the main sources of human campylobacteriosis, and there is clearly a need for new surveillance and control measures based on quantitative data on Campylobacter spp. colonization dynamics in broiler chickens. We conducted four experimental...... infection trials, using four isolators during each infection trial to evaluate colonization of individual broiler chickens by Campylobacter jejuni over time. Individual and pooled faecal samples were obtained at days 4, 7 and 12 post-inoculation (p.i.) and caecal samples at day 12 p.i. There were large...

Clinical Trials

Medline Plus

Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key ... Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

Replicating Experimental Impact Estimates Using a Regression Discontinuity Approach. NCEE 2012-4025

Science.gov (United States)

Gleason, Philip M.; Resch, Alexandra M.; Berk, Jillian A.

2012-01-01

This NCEE Technical Methods Paper compares the estimated impacts of an educational intervention using experimental and regression discontinuity (RD) study designs. The analysis used data from two large-scale randomized controlled trials--the Education Technology Evaluation and the Teach for America Study--to provide evidence on the performance of…

Inefficient cognitive control in adult ADHD: evidence from trial-by-trial Stroop test and cued task switching performance

Directory of Open Access Journals (Sweden)

Heuser Isabella

2007-08-01

Full Text Available Abstract Background Contemporary neuropsychological models of ADHD implicate impaired cognitive control as contributing to disorder characteristic behavioral deficiencies and excesses; albeit to varying degrees. While the traditional view of ADHD postulates a core deficiency in cognitive control processes, alternative dual-process models emphasize the dynamic interplay of bottom-up driven factors such as activation, arousal, alerting, motivation, reward and temporal processing with top-down cognitive control. However, neuropsychological models of ADHD are child-based and have yet to undergo extensive empirical scrutiny with respect to their application to individuals with persistent symptoms in adulthood. Furthermore, few studies of adult ADHD samples have investigated two central cognitive control processes: interference control and task-set coordination. The current study employed experimental chronometric Stroop and task switching paradigms to investigate the efficiency of processes involved in interference control and task-set coordination in ADHD adults. Methods 22 adults diagnosed with persistent ADHD (17 males and 22 matched healthy control subjects performed a manual trial-by-trial Stroop color-word test and a blocked explicitly cued task switching paradigm. Performance differences between neutral and incongruent trials of the Stroop task measured interference control. Task switching paradigm manipulations allowed for measurement of transient task-set updating, sustained task-set maintenance, preparatory mechanisms and interference control. Control analyses tested for the specificity of group × condition interactions. Results Abnormal processing of task-irrelevant stimulus features was evident in ADHD group performance on both tasks. ADHD group interference effects on the task switching paradigm were found to be dependent on the time allotted to prepare for an upcoming task. Group differences in sustained task-set maintenance and

Clinical Trials

Medline Plus

Full Text Available ... clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage. You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about ...

Effect of caffeine on cycling time-trial performance in the heat.

Science.gov (United States)

Pitchford, Nathan W; Fell, James W; Leveritt, Michael D; Desbrow, Ben; Shing, Cecilia M

2014-07-01

The purpose of this investigation was to determine whether a moderate dose of caffeine would improve a laboratory simulated cycling time-trial in the heat. Nine well-trained male subjects (VO2max 64.4±6.8mLmin(-1)kg(-1), peak power output 378±40W) completed one familiarisation and two experimental laboratory simulated cycling time-trials in environmental conditions of 35°C and 25% RH 90min after consuming either caffeine (3mgkg(-1) BW) or placebo, in a double blind, cross-over study. Time-trial performance was faster in the caffeine trial compared with the placebo trial (mean±SD, 3806±359s versus 4079±333s, p=0.06, 90%CI 42-500s, 86% likelihood of benefit, d=-0.79). Caffeine ingestion was associated with small to moderate increases in average heart rate (p=0.178, d=0.39), VO2 (p=0.154, d=0.45), respiratory exchange ratio (p=0.292, d=0.35) and core temperature (p=0.616, d=0.22) when compared to placebo, however, these were not statistically significant. Average RPE during the caffeine supplemented time-trial was not significantly different from placebo (p=0.41, d=-0.13). Caffeine supplementation at 3mgkg(-1) BW resulted in a worthwhile improvement in cycling time-trial performance in the heat. Double-blind cross-over study. Copyright © 2013 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Randomised controlled trials and changing public health practice

Directory of Open Access Journals (Sweden)

Anne Cockcroft

2017-05-01

Full Text Available Abstract One reason for doing randomised controlled trials (RCTs is that experiments can be convincing. Early epidemiological experimenters, such as Jenner and the smallpox vaccine and Snow and his famous Broad Street pump handle, already knew the answer they were demonstrating; they used the experiments as knowledge translation devices to convince others. More sophisticated modern experiments include cluster randomised controlled trials (CRCTs for experiments in the public health setting. The knowledge translation value remains: RCTs and CRCTs can potentially stimulate changes of practice among stakeholders. Capitalising on the knowledge translation value of RCTs requires more than the standard reporting of trials. Those who are convinced by a trial and want to act, need to know how the trial relates to their own context, what contributed to success, and what might make it even more effective. Implementation research unpacks the back-story, examining how and why an intervention worked. The Camino Verde trial of community mobilisation for control of dengue reported a significant impact on entomological indices of the Aedes aegypti vector, and on serological dengue virus infection and self-reported dengue cases. This important study should lead to studies of similar interventions in other contexts, and ultimately to changes in dengue control practices. This supplement is the back-story of the trial, providing information to help researchers and planners to make use of the trial findings. Background articles include the full protocol, a systematic review of CRCTs of approaches for Aedes aegypti control, epidemiological and entomological findings from the baseline survey, and how baseline findings were used to set up the intervention. Secondary analyses of the entomological findings examine associations with the use of the larvicide temephos, and the impact of the intervention in different conditions of water supply and seasons. Other articles

Formulation, quality control and shelf life of the experimental cytostatic drug cyclopentenyl cytosine

NARCIS (Netherlands)

Schimmel, Kirsten; Guchelaar, Henk-Jan; van Kan, Erik

2006-01-01

This paper describes the formulation and quality control of an aqueous sterilized formulation of the experimental cytostatic drug cyclopentenyl cytosine (CPEC) to be used in Phase I/II clinical trials. The raw drug substance was extensively tested. A High Pressure Liquid Chromotography (HPLC) method

SheppHeartCABG trial-comprehensive early rehabilitation after coronary artery bypass grafting

DEFF Research Database (Denmark)

Hojskov, Ida Elisabeth; Moons, Philip; Hansen, Niels Viggo

2017-01-01

rehabilitation. The SheppHeartCABG trial will investigate the effect of early comprehensive rehabilitation in early phase rehabilitation versus usual care. The aim of this paper is to present the protocol for the SheppHeartCABG trial. METHODS/ANALYSIS: SheppHeartCABG is an investigator-initiated randomised...... clinical superiority trial with blinded outcome assessment, employing 1:1 central randomisation to rehabilitation plus usual care versus usual care alone. On the basis of a sample size calculation, 326 patients undergoing coronary artery bypass grafting will be included from two clinical sites. All...... patients receive usual care and patients allocated to the experimental intervention follow 4 weeks rehabilitation consisting of an exercise programme, psycho-educative consultations and a compact mindfulness programme. The primary outcome is physical function measured by the 6-min walk test. The secondary...

Experimental transport phenomena and optimization strategies for thermoelectrics

Energy Technology Data Exchange (ETDEWEB)

Ehrlich, A C; Gillespie, D J

1997-07-01

When a new and promising thermoelectric material is discovered, an effort is undertaken to improve its figure of merit. If the effort is to be more efficient than one of trial and error with perhaps some rule of thumb guidance then it is important to be able to make the connection between experimental data and the underlying material characteristics, electronic and phononic, that influence the figure of merit. Transport and fermiology experimental data can be used to evaluate these material characteristics and thus establish trends as a function of some controllable parameter, such as composition. In this paper some of the generic-materials characteristics, generally believed to be required for a high figure of merit, will be discussed in terms of the experimental approach to their evaluation and optimization. Transport and fermiology experiments will be emphasized and both will be outlined in what they can reveal and what can be obscured by the simplifying assumptions generally used in their interpretation.

Clinical Trials

Medline Plus

Full Text Available ... need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in ... Maryland, runs clinical trials. Many other clinical trials take place in medical centers and ... trial can have many benefits. For example, you may gain access to new treatments before ...

Leidos Biomed Supports Clinical Trials for Vaccine Against Mosquito-borne Chikungunya | FNLCR Staging

Science.gov (United States)

An experimental vaccine for mosquito-borne chikungunya is being tested at sites in the Caribbean as part of a phase II clinical trial being managed by the Frederick National Lab. No vaccine or treatment currently exists for the viral disease, which c

Combining dosimetry and toxicity: analysis of two UK phase III clinical trials

International Nuclear Information System (INIS)

Gulliford, Sarah L

2014-01-01

There are many advantages to performing a clinical trial when implementing a novel radiotherapy technique. The clinical trials framework enables the safety and efficacy of the 'experimental arm' to be tested and ensures practical support, rigorous quality control and data monitoring for participating centres. In addition to the clinical and follow-up data collected from patients within the trial, it is also possible to collect 3-D dosimetric information from the corresponding radiotherapy treatment plans. Analysing the combination of dosimetric, clinical and follow-up data enhances the understanding of the relationship between the dose delivered to both the target and normal tissue structures and reported outcomes and toxicity. Aspects of the collection, collation and analysis of data from two UK multicentre Phase III radiotherapy trials are presented here. MRC-RT01 dose-escalation prostate radiotherapy trial ISRCTN47772397 was one of the first UK multi-centre radiotherapy trials to collect 3-D dosimetric data. A number of different analysis methodologies were implemented to investigate the relationship between the dose distribution to the rectum and specific rectal toxicities. More recently data was collected from the PARSPORT trial (Parotid Sparing IMRT vs conventional head and neck radiotherapy) ISRCTN48243537. In addition to the planned analysis, dosimetric analysis was employed to investigate an unexpected finding that acute fatigue was more prevalent in the IMRT arm of the trial. It can be challenging to collect 3-D dosimetric information from multicentre radiotherapy trials. However, analysing the relationship between dosimetric and toxicity data provides invaluable information which can influence the next generation of radiotherapy techniques.

Can training improve laypersons helping behaviour in first aid? A randomised controlled deception trial.

Science.gov (United States)

Van de Velde, Stijn; Roex, Ann; Vangronsveld, Karoline; Niezink, Lidewij; Van Praet, Koen; Heselmans, Annemie; Donceel, Peter; Vandekerckhove, Philippe; Ramaekers, Dirk; Aertgeerts, Bert

2013-04-01

There is limited evidence indicating that laypersons trained in first aid provide better help, but do not help more often than untrained laypersons. This study investigated the effect of conventional first aid training versus conventional training plus supplementary training aimed at decreasing barriers to helping. The authors conducted a randomised controlled trial. After 24 h of conventional first aid training, the participants either attended an experimental lesson to reduce barriers to helping or followed a control lesson. The authors used a deception test to measure the time between the start of the unannounced simulated emergency and seeking help behaviour and the number of particular helping actions. The authors randomised 72 participants to both groups. 22 participants were included in the analysis for the experimental group and 36 in the control group. The authors found no statistically or clinically significant differences for any of the outcome measures. The time until seeking help (geometrical mean and 95% CI) was 55.5 s (42.9 to 72.0) in the experimental group and 56.5 s (43.0 to 74.3) in the control group. 57% of the participants asked a bystander to seek help, 40% left the victim to seek help themselves and 3% did not seek any help. Supplementary training on dealing with barriers to helping did not alter the helping behaviour. The timing and appropriateness of the aid provided can be improved. The authors registered this trial at ClinicalTrials.gov as NCT00954161.

Physical activity and trial-by-trial adjustments of response conflict.

Science.gov (United States)

Kamijo, Keita; Takeda, Yuji

2013-08-01

The relationship of physical activity to trial-by-trial adjustments of response conflict was assessed using behavioral task performance, the N2 event-related brain potential component, and phase-locking values (PLVs) in a lower gamma band during a perceptual conflict task. Nineteen physically active and 19 inactive young adults (mean age = 21.3 years) performed a Navon task, using a global letter made up of local letters of either the same kind (congruent trials) or a different kind (incongruent trials). Findings revealed that active individuals exhibited smaller N2 amplitudes and greater PLVs on incongruent trials that were preceded by incongruent trials compared with those preceded by congruent trials. Such phenomena were not observed for inactive individuals. These results suggest that greater physical activity is associated with larger trial-by-trial adjustments of response conflict, which we attribute to upregulation of top-down cognitive control and reductions in response conflict.

Clinical trials in dentistry in India: Analysis from trial registry.

Science.gov (United States)

Gowri, S; Kannan, Sridharan

2017-01-01

Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy

Angulated Dental Implants in Posterior Maxilla FEA and Experimental Verification

Directory of Open Access Journals (Sweden)

Hamed A. Hamed

2018-02-01

Full Text Available AIM: This study aimed to evaluate the effect of different implant angulations in posterior maxilla on stress distribution by finite element analysis and verify its results experimentally. METHODS: Two simplified models were prepared for an implant placed vertically and tilted 25° piercing the maxillary sinus. Geometric models' components were prepared by Autodesk Inventor then assembled in ANSYS for finite element analysis. The results of finite element analysis were verified against experimental trials results which were statistically analysed using student t-test (level of significance p < 0.05. RESULTS: Implant - abutment complex absorbed the load energy in case of vertical implant better than the case of angulated one. That was reflected on cortical bone stress, while both cases showed stress levels within the physiological limits. Comparing results between FEA and experiment trials showed full agreement. CONCLUSION: It was found that the tilted implant by 25° can be utilised in the posterior region maxilla for replacing maxillary first molar avoiding sinus penetration. The implant-bone interface and peri-implant bones received the highest Von Mises stress. Implant - bone interface with angulated implant received about 66% more stresses than the straight one.

Angulated Dental Implants in Posterior Maxilla FEA and Experimental Verification.

Science.gov (United States)

Hamed, Hamed A; Marzook, Hamdy A; Ghoneem, Nahed E; El-Anwar, Mohamed I

2018-02-15

This study aimed to evaluate the effect of different implant angulations in posterior maxilla on stress distribution by finite element analysis and verify its results experimentally. Two simplified models were prepared for an implant placed vertically and tilted 25° piercing the maxillary sinus. Geometric models' components were prepared by Autodesk Inventor then assembled in ANSYS for finite element analysis. The results of finite element analysis were verified against experimental trials results which were statistically analysed using student t-test (level of significance p < 0.05). Implant - abutment complex absorbed the load energy in case of vertical implant better than the case of angulated one. That was reflected on cortical bone stress, while both cases showed stress levels within the physiological limits. Comparing results between FEA and experiment trials showed full agreement. It was found that the tilted implant by 25° can be utilised in the posterior region maxilla for replacing maxillary first molar avoiding sinus penetration. The implant-bone interface and peri-implant bones received the highest Von Mises stress. Implant - bone interface with angulated implant received about 66% more stresses than the straight one.

Handcrafted Vacuum-Assisted Device for Skin Ulcers Treatment Versus Traditional Therapy, Randomized Controlled Trial.

Science.gov (United States)

Gonzalez, Israel Gonzalez; Angel, Medina Andrade Luis; Baez, Maria Valeria Jimenez; Ruiz Flores, Brenda; de Los Angeles Martinez Ferretiz, Maria; Woolf, Stephanny Vanestty; López, Israel; Sandoval-Jurado, Luis; Pat-Espadas, Fany Guadalupe; Cruz, Alan Alejandro Reyes; Delgado, Arsenio Torres

2017-02-01

Chronic lower limb ulcers constitute a public health problem, with important socioeconomic implications and high attention cost. This trial evaluates handcrafted vacuum-assisted therapy versus traditional treatment effectiveness for lower limbs ulcers. It was a prospective randomized clinical trial conducted over 144 patients with lower limbs ulcers. Patients were randomized into two groups of 72 patients: Experimental group were treated with debridement, cure and a handcrafted vacuum-assisted device that was changed every 72 h. Control group was treated with debridement and cure with soap every 24 h. Ulcers were evaluated every 72 h and on 10th day. The presence of systemic inflammatory response, pain, granulation tissue and viability for discharge was registered and analyzed . After exclusion of 18 patients, 126 were included, 65.1% were men with an average of 58 years. Sole region ulcer by diabetic foot was the more frequent in both groups (73%). Leukocytes count, systemic inflammatory response and pain were significantly lower in experimental group (p ulcers. This system would benefit patients favoring earlier infection control, faster granulation tissue appearance and earlier discharge. Clinical trials registered in https://www.clinicaltrials.gov/ Number NCT02512159.

Experimental investigations of a chimney-dependent solar crop dryer

Energy Technology Data Exchange (ETDEWEB)

Afriyie, J.K.; Nazha, M.A.A.; Rajakaruna, H. [School of Engineering and Technology, De Montfort University, Queens Building, The Gateway, Leicester LE1 9BH (United Kingdom); Forson, F.K. [Department of Mechanical Engineering, Kwame Nkrumah University of Science and Technology, Kumasi (Ghana)

2009-01-15

An experimental investigation into the performance of a solar crop dryer with solar chimney and no air preheating is described. Tests were first performed on the cabinet dryer, using a normal chimney. The trials were repeated with a solar chimney. Still with the solar chimney, further trials were carried out with the roof of the drying chamber inclined further to form a tent dryer. The described tests include no-load tests for airflow rate measurements and drying tests, with cassava as the crop. Air velocities, temperatures, ambient relative humidity and the drop in crop moisture contents at different stages of the drying process are also presented. The effects of the various configurations described above on the drying process are deduced and discussed while comparing the experimental results with one another. In addition, the performance of the dryer in relation to other natural convection dryers is discussed. The results show that the solar chimney can increase the airflow rate of a direct-mode dryer especially when it is well designed with the appropriate angle of drying-chamber roof. However, the increase in flow rate only increases the drying rate when the relative humidity (RH) of the ambient air is below a certain mark (60% for cassava). (author)

Experimental vaccine against lactococcosis in cultured rainbowtrout (Oncorhynchus mykiss

Directory of Open Access Journals (Sweden)

Moazzeni Jula, Gh.

2011-06-01

Full Text Available Lactococcus garvieae is the etiological agent of lactococcosis, an emerging disease which affects several fish species and causes important economic losses both in marine and freshwater aquaculture. Lactococcosis usually happens when water temperature increases over 15°C during the year. Normally, it causes a hyperacute and haemorrhagic septicemia in fish. This paper presents a procedure for producing experimental vaccine for rainbow trout (Oncorhynchus mykiss lactococcosis including aspects such as pathogen characterization, pathogenicity, mass cultivation, safety, potency and field trial tests for immersion use. In the potency test, after challenging the vaccinated fish with live pathogenic bacteria (1×107 bacteria per milliliter of immersing solution and observing for 72 hours thereafter, 10% of fish died while the control group showed 60% mortality within the observation time. In the field trial from vaccination time onward till marketing of the fish, those mortalities that occurred in groups of vaccinated and non-vaccinated fish were recorded. Total death occurred in the vaccinated group was 11%, while in non vaccinated group this number was approaching 23%. This observation indicates a 50% reduction in mortality in the vaccinated group. This is the first report on experimental vaccine against lactococcosis in fish that is produced and tested in Iran.

New experimental treatments for core social domain in autism spectrum disorders.

Science.gov (United States)

Canitano, Roberto

2014-01-01

Current therapeutics in autism spectrum disorders (ASD) only treat the associated symptoms, without addressing core social dysfunctions. A paradigm shift in research of the pathogenesis of ASD, its synaptic abnormalities and altered signaling in multiple dynamic systems, have led to new experimental treatments for treating the core social abnormalities of ASD. NMDA antagonists, especially memantine, have been introduced in clinical trials addressing glutamatergic transmission in children and adolescents with ASD. GABAergic signaling has been targeted in trials using the GABAB receptor agonist arbaclofen for ASD patients with promising results. Oxytocin has been recognized as implicated in social development and affiliative behaviors. Preliminary findings from clinical trials using oxytocin in children with ASD show encouraging improvements in social cognition, but larger studies are needed. In two of the single gene disorders associated with ASD, Insulin Growth Factor (IGF-1) is a new treatment that has been tested in Rett syndrome and Phelan-McDermid syndrome (Chromosome 22 deletion syndrome). IGF-1 has been demonstrated to reverse the reduction in the number of excitatory synapses and the density of neurons that characterize these conditions in animal studies and it is being introduced as an experimental treatment. As a novel approach to verify treatment efficacy, neural processing modifications were recently evaluated by fMRI after a pivotal response training intervention. Another study of neural changes in response to treatment examined variations in EEG signaling in patients after an Early Start Denver Model (ESDM) intervention.

New experimental treatments of core social domain in Autism Spectrum Disorders

Directory of Open Access Journals (Sweden)

Roberto eCanitano

2014-06-01

Full Text Available Current therapeutics in Autism Spectrum Disorders (ASD only treat the associated symptoms, without addressing core social dysfunctions. A paradigm shift in research of the pathogenesis of ASD, its synaptic abnormalities and altered signaling in multiple dynamic systems, have led to new experimental treatments for treating the core social abnormalities of ASD. NMDA antagonists, especially memantine, have been introduced in clinical trials addressing glutamatergic transmission in children and adolescents with ASD. GABAergic signaling has been targeted in trials using the GABAB receptor agonist arbaclofen for ASD patients with promising results. Oxytocin has been recognized as implicated in social development and affiliative behaviours. Preliminary findings from clinical trials using oxytocin in children with ASD show encouraging improvements in social cognition, but larger studies are needed. In two of the single gene disorders associated with ASD, Insulin Growth Factor (IGF-1 is a new treatment that has been tested in Rett Syndrome and Phelan-McDermid Syndrome (Chromosome 22 deletion syndrome. IGF-1 has been demonstrated to reverse the reduction in the number of excitatory synapses and the density of neurons that characterize these conditions in animal studies and it is being introduced as an experimental treatment..As a novel approach to verify treatment efficacy,neural processing modifications were recently evaluated by fMRI after a Pivotal Response Training (PRT intervention. Another study of neural changes in response to treatment examined variations in EEG signaling in patientsafter an Early Start Denver Model (ESDM intervention.

Inadequate description of educational interventions in ongoing randomized controlled trials

Directory of Open Access Journals (Sweden)

Pino Cécile

2012-05-01

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

Recruitment to publicly funded trials--are surgical trials really different?

Science.gov (United States)

Cook, Jonathan A; Ramsay, Craig R; Norrie, John

2008-09-01

Good recruitment is integral to the conduct of a high-quality randomised controlled trial. It has been suggested that recruitment is particularly difficult for evaluations of surgical interventions, a field in which there is a dearth of evidence from randomised comparisons. While there is anecdotal speculation to support the inference that recruitment to surgical trials is more challenging than for medical trials we are unaware of any formal assessment of this. In this paper, we compare recruitment to surgical and medical trials using a cohort of publicly funded trials. Overall recruitment to trials was assessed using of a cohort of publicly funded trials (n=114). Comparisons were made by using the Recruitment Index, a simple measure of recruitment activity for multicentre randomised controlled trials. Recruitment at the centre level was also investigated through three example surgical trials. The Recruitment Index was found to be higher, though not statistically significantly, in the surgical group (n=18, median=38.0 IQR (10.7, 77.4)) versus (n=81, median=34.8 IQR (11.7, 98.0)) days per recruit for the medical group (median difference 1.7 (-19.2, 25.1); p=0.828). For the trials where the comparison was between a surgical and a medical intervention, the Recruitment Index was substantially higher (n=6, 68.3 (23.5, 294.8)) versus (n=93, 34.6 (11.7, 90.0); median difference 25.9 (-35.5, 221.8); p=0.291) for the other trials. There was no clear evidence that surgical trials differ from medical trials in terms of recruitment activity. There was, however, support for the inference that medical versus surgical trials are more difficult to recruit to. Formal exploration of the recruitment data through a modelling approach may go some way to tease out where important differences exist.

The GReat-Child™ Trial: A Quasi-Experimental Intervention on Whole Grains with Healthy Balanced Diet to Manage Childhood Obesity in Kuala Lumpur, Malaysia

Directory of Open Access Journals (Sweden)

Hui Chin Koo

2018-01-01

Full Text Available Background: The GReat-Child Trial was a quasi-experimental intervention that has emphasized whole grain as a strategy to manage childhood obesity. Methods: Two schools in Kuala Lumpur with similar demographic characteristics were assigned as intervention (IG and control (CG. Eligibility criteria were overweight/obese children aged 9 to 11 years who had no serious co-morbidity. Children who reported consuming wholegrain foods in their 3-day diet-recall during screening were excluded. A total of 63 children (31 IG; 32 CG completed the entire intervention program. The IG children underwent six 30-min nutrition education lessons and had school delivery of wholegrain food on a daily basis over a 12-week period. Parents of IG children attended 1-h individual diet counseling. Anthropometric outcomes including BMI-for-age z-score (BAZ, body fat percentage and waist circumference were measured at baseline [T0], post-intervention [T1] (3rd month and follow-up [T2] (9th month. Results: IG showed significantly lower BAZ (weighted difference: −0.12; 95% CI: −0.21, −0.03; p = 0.009, body fat percentage (weighted difference: −2.6%; 95% CI: −3.7, −1.5; p < 0.001 and waist circumference (weighted difference: −2.4 cm; 95% CI: −3.8, −1.0; p = 0.001 compared to CG. IG reported significantly lower body fat percentage (weighted difference: −3.4%; 95% CI: 1.8, 5.0; p < 0.001 and waist circumference (weighted difference: −2.1 cm; 95% CI: −3.7, −0.5; p = 0.014 at T1 compared to T0. Conclusions: The GReat-Child Trial made a positive impact in managing childhood obesity. It can be incorporated into childhood obesity intervention programs that are being implemented by the policy makers.

The GReat-Child™ Trial: A Quasi-Experimental Intervention on Whole Grains with Healthy Balanced Diet to Manage Childhood Obesity in Kuala Lumpur, Malaysia.

Science.gov (United States)

Koo, Hui Chin; Poh, Bee Koon; Abd Talib, Ruzita

2018-01-30

Background: The GReat-Child Trial was a quasi-experimental intervention that has emphasized whole grain as a strategy to manage childhood obesity. Methods: Two schools in Kuala Lumpur with similar demographic characteristics were assigned as intervention (IG) and control (CG). Eligibility criteria were overweight/obese children aged 9 to 11 years who had no serious co-morbidity. Children who reported consuming wholegrain foods in their 3-day diet-recall during screening were excluded. A total of 63 children (31 IG; 32 CG) completed the entire intervention program. The IG children underwent six 30-min nutrition education lessons and had school delivery of wholegrain food on a daily basis over a 12-week period. Parents of IG children attended 1-h individual diet counseling. Anthropometric outcomes including BMI-for-age z-score (BAZ), body fat percentage and waist circumference were measured at baseline [T0], post-intervention [T1] (3rd month) and follow-up [T2] (9th month). Results: IG showed significantly lower BAZ (weighted difference: -0.12; 95% CI: -0.21, -0.03; p = 0.009), body fat percentage (weighted difference: -2.6%; 95% CI: -3.7, -1.5; p < 0.001) and waist circumference (weighted difference: -2.4 cm; 95% CI: -3.8, -1.0; p = 0.001) compared to CG. IG reported significantly lower body fat percentage (weighted difference: -3.4%; 95% CI: 1.8, 5.0; p < 0.001) and waist circumference (weighted difference: -2.1 cm; 95% CI: -3.7, -0.5; p = 0.014) at T1 compared to T0. Conclusions: The GReat-Child Trial made a positive impact in managing childhood obesity. It can be incorporated into childhood obesity intervention programs that are being implemented by the policy makers.

Microbiological profile and calprotectin expression in naturally occurring and experimentally induced gingivitis.

Science.gov (United States)

Farina, Roberto; Guarnelli, Maria Elena; Figuero, Elena; Herrera, David; Sanz, Mariano; Trombelli, Leonardo

2012-10-01

This study was performed to evaluate the microbiological profile and the calprotectin expression in gingival crevicular fluid (GCF) in spontaneous and experimentally induced gingival inflammation. Thirty-seven periodontally healthy subjects were evaluated in real life conditions (N-O gingivitis) as well as after 21 days of experimental gingivitis trial (E-I gingivitis). During the experimental gingivitis trial, in one maxillary quadrant (test quadrant), gingival inflammation was induced by oral hygiene abstention, while in the contralateral (control) quadrant, oral hygiene was routinely continued. The results of the study showed that (1) the microbiological profile of quadrants where gingival inflammation was experimentally induced (i.e., E-I test quadrants) differed significantly from that of either quadrants where gingival inflammation was controlled by proper plaque control (i.e., E-I control quadrants) or quadrants with N-O gingivitis, and (2) GCF calprotectin was significantly higher at E-I test quadrants compared to either E-I control quadrants or quadrants with N-O gingivitis. A positive intrasubject correlation was found between GCF concentration of calprotectin at sites presenting N-O and E-I gingivitis. N-O and E-I gingivitis showed a different microbiological profile of the subgingival environment. GCF calprotectin is a reliable marker of gingival inflammation, and its concentration in N-O gingivitis is correlated with its expression in E-I gingivitis. The modality of plaque accumulation seems to affect the subgingival microbiological profile associated with a gingivitis condition. Calprotectin levels in GCF may be regarded as a promising marker of the individual susceptibility to develop gingival inflammation in response to experimentally induced plaque accumulation.

Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

Science.gov (United States)

Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

2012-07-01

Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

Clinical pharmacists on medical care of pediatric inpatients: a single-center randomized controlled trial.

Directory of Open Access Journals (Sweden)

Chuan Zhang

Full Text Available OBJECTIVE: To explore the best interventions and working patterns of clinical pharmacists in pediatrics and to determine the effectiveness of clinical pharmacists in pediatrics. METHODS: We conducted a randomized controlled trial of 160 pediatric patients with nerve system disease, respiratory system disease or digestive system disease, who were randomly allocated into two groups, with 80 in each group. Interventions by clinical pharmacists in the experimental group included answering questions of physicians and nurses, giving advice on treating patients, checking prescriptions and patient counseling at discharge. In the control group, patients were treated without clinical pharmacist interventions. RESULTS: Of the 109 interventions provided by clinical pharmacists during 4 months, 47 were consultations for physicians and nurses, 31 were suggestions of treatment, with 30 accepted by physicians (96.77% and 31 were medical errors found in 641 prescriptions. Five adverse drug reactions were submitted to the adverse drug reaction monitoring network, with three in the experimental group and two in the control group. The average length of stay (LOS for patients with respiratory system diseases in the experimental group was 6.45 days, in comparison with 10.83 days in the control group, which was statistically different (p value<0.05; Average drug compliance rate in the experimental group was 81.41%, in comparison with 70.17% of the control group, which was statistically different (p value<0.05. Cost of drugs and hospitalization and rate of readmission in two weeks after discharge in the two groups were not statistically different. CONCLUSION: Participation by clinical pharmacists in the pharmacotherapy of pediatric patients can reduce LOS of patients with respiratory system disease and improve compliance rate through discharge education, showing no significant effects on prevention of ADR, reduction of cost of drugs and hospitalization and readmission

Experimental Treatment of Ebola Virus Disease with TKM-130803: A Single-Arm Phase 2 Clinical Trial.

Science.gov (United States)

Dunning, Jake; Sahr, Foday; Rojek, Amanda; Gannon, Fiona; Carson, Gail; Idriss, Baimba; Massaquoi, Thomas; Gandi, Regina; Joseph, Sebatu; Osman, Hassan K; Brooks, Timothy J G; Simpson, Andrew J H; Goodfellow, Ian; Thorne, Lucy; Arias, Armando; Merson, Laura; Castle, Lyndsey; Howell-Jones, Rebecca; Pardinaz-Solis, Raul; Hope-Gill, Benjamin; Ferri, Mauricio; Grove, Jennifer; Kowalski, Mark; Stepniewska, Kasia; Lang, Trudie; Whitehead, John; Olliaro, Piero; Samai, Mohammed; Horby, Peter W

2016-04-01

TKM-130803, a small interfering RNA lipid nanoparticle product, has been developed for the treatment of Ebola virus disease (EVD), but its efficacy and safety in humans has not been evaluated. In this single-arm phase 2 trial, adults with laboratory-confirmed EVD received 0.3 mg/kg of TKM-130803 by intravenous infusion once daily for up to 7 d. On days when trial enrolment capacity was reached, patients were enrolled into a concurrent observational cohort. The primary outcome was survival to day 14 after admission, excluding patients who died within 48 h of admission. After 14 adults with EVD had received TKM-130803, the pre-specified futility boundary was reached, indicating a probability of survival to day 14 of ≤0.55, and enrolment was stopped. Pre-treatment geometric mean Ebola virus load in the 14 TKM-130803 recipients was 2.24 × 109 RNA copies/ml plasma (95% CI 7.52 × 108, 6.66 × 109). Two of the TKM-130803 recipients died within 48 h of admission and were therefore excluded from the primary outcome analysis. Of the remaining 12 TKM-130803 recipients, nine died and three survived. The probability that a TKM-130803 recipient who survived for 48 h will subsequently survive to day 14 was estimated to be 0.27 (95% CI 0.06, 0.58). TKM-130803 infusions were well tolerated, with 56 doses administered and only one possible infusion-related reaction observed. Three patients were enrolled in the observational cohort, of whom two died. Administration of TKM-130803 at a dose of 0.3 mg/kg/d by intravenous infusion to adult patients with severe EVD was not shown to improve survival when compared to historic controls. Pan African Clinical Trials Registry PACTR201501000997429.

L'invisible invité

OpenAIRE

Frémy, Anne

2012-01-01

Tiré du site Internet de Onestar Press: ""They’re a kind of cabin or hut, very basic and awkwardly assembled, wedged into the space of the balcony between the guardrail and the wall of the building.The vertical sides are made of plywood, canvas or tarp, and are topped by a vegetal roofing that is more or less dry, more or less green, threaded with palm wattle. These huts are opaque and seem to communicate with apartments…" Excerpt from L’Invisible invité by Anne Frémy, english by Bruce Bender...

RARtool: A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes.

Science.gov (United States)

Ryeznik, Yevgen; Sverdlov, Oleksandr; Wong, Weng Kee

2015-08-01

Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool , a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simulations, an investigator can assess design characteristics under a variety of experimental scenarios and select the best procedure for practical implementation. We illustrate the utility of our RARtool software by redesigning a survival trial from the literature.

Clinical Trials

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Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...

Clinical Trials

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Full Text Available ... Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance ...

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Full Text Available ... more information about eligibility criteria, go to "How Do Clinical Trials Work?" Some trials enroll people who ... for adults. For more information, go to "How Do Clinical Trials Protect Participants?" For more information about ...

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Full Text Available ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

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Full Text Available ... clinical trials are vital to the process of improving medical care. Many people volunteer because they want ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

Clinical Trials

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Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

Clinical Trials

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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... from a study at any time, for any reason. Also, during the trial, you have the right ...

Clinical Trials

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Full Text Available ... you agree to take part in the trial. Talk with your doctor about specific trials you're ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

Clinical Trials

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Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

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Full Text Available ... any clinical trial before you agree to take part in the trial. Talk with your doctor about specific trials you're interested in. For a list of questions to ask your doctor and the ...

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Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

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Full Text Available ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ... stop a trial, or part of a trial, early if the strategy or treatment is having harmful ...

Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

International Nuclear Information System (INIS)

Poh, Catherine F; Durham, J Scott; Brasher, Penelope M; Anderson, Donald W; Berean, Kenneth W; MacAulay, Calum E; Lee, J Jack; Rosin, Miriam P

2011-01-01

Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in

Clinical Trials

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Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

The effects of gait retraining in runners with patellofemoral pain: A randomized trial.

Science.gov (United States)

Roper, Jenevieve L; Harding, Elizabeth M; Doerfler, Deborah; Dexter, James G; Kravitz, Len; Dufek, Janet S; Mermier, Christine M

2016-06-01

Running popularity has increased resulting in a concomitant increase in running-related injuries with patellofemoral pain most commonly reported. The purpose of this study was to determine whether gait retraining by modifying footstrike patterns from rearfoot strike to forefoot strike reduces patellofemoral pain and improves associated biomechanical measures, and whether the modification influences risk of ankle injuries. Sixteen subjects (n=16) were randomly placed in the control (n=8) or experimental (n=8) group. The experimental group performed eight gait retraining running sessions over two weeks where footstrike pattern was switched from rearfoot strike to forefoot strike, while the control group performed running sessions with no intervention. Variables were recorded pre-, post-, and one-month post-running trials. Knee pain was significantly reduced post-retraining (Pforefoot strike pattern leads to reduced knee pain, and should be considered a possible strategy for management of patellofemoral pain in recreational runners. This trial is registered at the US National Institutes of Health (clinicaltrials.gov) #NCT02567123. Published by Elsevier Ltd.

Clinical Trials

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Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...

Neural-humoral responses during head-up tilt in healthy young white and black women

Science.gov (United States)

Jarvis, Sara S.; Shibata, Shigeki; Okada, Yoshiyuki; Levine, Benjamin D.; Fu, Qi

2014-01-01

Young black women have higher prevalence of hypertension during pregnancy compared to white women, which may be attributable to differences in blood pressure (BP) regulation. We hypothesized that young normotensive black women would demonstrate augmented muscle sympathetic nerve activity (MSNA) and renal-adrenal responses to orthostasis. Fifteen white and ten black women (30 ± 4 vs. 32 ± 6 years; means ± SD) had haemodynamics and MSNA measured during baseline (BL), 30 and 60° head-up tilt (HUT), and recovery. Blood was drawn for catecholamines, direct renin, vasopressin, and aldosterone. BL brachial systolic BP (SBP: 107 ± 6 vs. 101 ± 9 mmHg) and diastolic BP (DBP: 62 ± 4 vs. 56 ± 7 mmHg) were higher in white women (both p < 0.05). Δ DBP (60° HUT-BL) was greater in black women compared to white (p < 0.05). Cardiac output and total peripheral resistance were similar between groups. MSNA burst frequency was higher in whites (BL: 16 ± 10 vs. 14 ± 9 bursts/min, main effect p < 0.05) and increased in both groups during HUT (60°: 39 ± 8 vs. 34 ± 13 bursts/min, p < 0.05 from BL). Noradrenaline was higher in white women during 60° HUT (60° HUT: 364 ± 102 vs. 267 ± 89 pg/ml, p < 0.05). Direct renin was higher and vasopressin and Δ aldosterone tended to be higher in blacks (BL, direct renin: 12.1 ± 5.0 vs. 14.4 ± 3.7 pg/ml, p < 0.05; BL, vasopressin: 0.4 ± 0.0 vs. 1.6 ± 3.6 pg/ml, p = 0.065; Δ aldosterone: −0.9 ± 5.1 vs. 3.8 ± 7.5 ng/ml; p = 0.069). These results suggest that young normotensive white women may rely on sympathetic neural activity more so than black women who have a tendency to rely on the renal-adrenal system to regulate BP during an orthostatic stress. PMID:24624092

Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

Directory of Open Access Journals (Sweden)

Joseph S Ross

2009-09-01

Full Text Available ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006.Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data

Trial Watch: Toll-like receptor agonists in oncological indications.

Science.gov (United States)

Aranda, Fernando; Vacchelli, Erika; Obrist, Florine; Eggermont, Alexander; Galon, Jérôme; Sautès-Fridman, Catherine; Cremer, Isabelle; Henrik Ter Meulen, Jan; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

2014-01-01

Toll-like receptors (TLRs) are an evolutionarily conserved group of enzymatically inactive, single membrane-spanning proteins that recognize a wide panel of exogenous and endogenous danger signals. Besides constituting a crucial component of the innate immune response to bacterial and viral pathogens, TLRs appear to play a major role in anticancer immunosurveillance. In line with this notion, several natural and synthetic TLR ligands have been intensively investigated for their ability to boost tumor-targeting immune responses elicited by a variety of immunotherapeutic and chemotherapeutic interventions. Three of these agents are currently approved by the US Food and Drug Administration (FDA) or equivalent regulatory agencies for use in cancer patients: the so-called bacillus Calmette-Guérin, monophosphoryl lipid A, and imiquimod. However, the number of clinical trials testing the therapeutic potential of both FDA-approved and experimental TLR agonists in cancer patients is stably decreasing, suggesting that drug developers and oncologists are refocusing their interest on alternative immunostimulatory agents. Here, we summarize recent findings on the use of TLR agonists in cancer patients and discuss how the clinical evaluation of FDA-approved and experimental TLR ligands has evolved since the publication of our first Trial Watch dealing with this topic.

Stochastic resonance whole-body vibration improves postural control in health care professionals: a worksite randomized controlled trial.

Science.gov (United States)

Elfering, Achim; Schade, Volker; Stoecklin, Lukas; Baur, Simone; Burger, Christian; Radlinger, Lorenz

2014-05-01

Slip, trip, and fall injuries are frequent among health care workers. Stochastic resonance whole-body vibration training was tested to improve postural control. Participants included 124 employees of a Swiss university hospital. The randomized controlled trial included an experimental group given 8 weeks of training and a control group with no intervention. In both groups, postural control was assessed as mediolateral sway on a force plate before and after the 8-week trial. Mediolateral sway was significantly decreased by stochastic resonance whole-body vibration training in the experimental group but not in the control group that received no training (p < .05). Stochastic resonance whole-body vibration training is an option in the primary prevention of balance-related injury at work. Copyright 2014, SLACK Incorporated.

Funding source, conflict of interest and positive conclusions in neuro-oncology clinical trials.

Science.gov (United States)

Moraes, Fabio Y; Mendez, Lucas C; Taunk, Neil K; Raman, Srinivas; Suh, John H; Souhami, Luis; Slotman, Ben; Weltman, Eduardo; Spratt, Daniel E; Berlin, Alejandro; Marta, Gustavo N

2018-02-01

We aimed to test any association between authors' conclusions and self-reported COI or funding sources in central nervous system (CNS) studies. A review was performed for CNS malignancy clinical trials published in the last 5 years. Two investigators independently classified study conclusions according to authors' endorsement of the experimental therapy. Statistical models were used to test for associations between positive conclusions and trials characteristics. From February 2010 to February 2015, 1256 articles were retrieved; 319 were considered eligible trials. Positive conclusions were reported in 56.8% of trials with industry-only, 55.6% with academia-only, 44.1% with academia and industry, 77.8% with none, and 76.4% with not described funding source (p = 0.011). Positive conclusions were reported in 60.4% of trials with unrelated COI, 60% with related COI, and 60% with no COI reported (p = 0.997). Factors that were significantly associated with the presence of positive conclusion included trials design (phase 1) [OR 11.64 (95 CI 4.66-29.09), p source [OR 2.45 (95 CI 1.22-5.22), p = 0.011]. In a multivariable regression model, all these factors remained significantly associated with trial's positive conclusion. Funding source and self-reported COI did not appear to influence the CNS trials conclusion. Funding source information and COI disclosure were under-reported in 14.1 and 17.2% of the CNS trials. Continued efforts are needed to increase rates of both COI and funding source reporting.

Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial.

Science.gov (United States)

Tanaka, Atsushi; Shimabukuro, Michio; Okada, Yosuke; Taguchi, Isao; Yamaoka-Tojo, Minako; Tomiyama, Hirofumi; Teragawa, Hiroki; Sugiyama, Seigo; Yoshida, Hisako; Sato, Yasunori; Kawaguchi, Atsushi; Ikehara, Yumi; Machii, Noritaka; Maruhashi, Tatsuya; Shima, Kosuke R; Takamura, Toshinari; Matsuzawa, Yasushi; Kimura, Kazuo; Sakuma, Masashi; Oyama, Jun-Ichi; Inoue, Teruo; Higashi, Yukihito; Ueda, Shinichiro; Node, Koichi

2017-04-12

Type 2 diabetes mellitus (T2DM) is characterized by systemic metabolic abnormalities and the development of micro- and macrovascular complications, resulting in a shortened life expectancy. A recent cardiovascular (CV) safety trial, the EMPA-REG OUTCOME trial, showed that empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, markedly reduced CV death and all-cause mortality and hospitalization for heart failure in patients with T2DM and established CV disease (CVD). SGLT2 inhibitors are known to not only decrease plasma glucose levels, but also favorably modulate a wide range of metabolic and hemodynamic disorders related to CV pathways. Although some experimental studies revealed a beneficial effect of SGLT2 inhibitors on atherosclerosis, there is a paucity of clinical data showing that they can slow the progression of atherosclerosis in patients with T2DM. Therefore, the EMBLEM trial was designed to investigate whether empagliflozin treatment can improve endothelial function, which plays a pivotal role in the pathogenesis of atherosclerosis, in patients with T2DM and established CVD. The EMBLEM trial is an ongoing, prospective, multicenter, placebo-controlled double-blind randomized, investigator-initiated clinical trial in Japan. A total of 110 participants with T2DM (HbA1c range 6.0-10.0%) and with established CVD will be randomized (1:1) to receive either empagliflozin 10 mg once daily or a placebo. The primary endpoint of the trial is change in the reactive hyperemia (RH)-peripheral arterial tonometry-derived RH index at 24 weeks from baseline. For comparison of treatment effects between the treatment groups, the baseline-adjusted means and their 95% confidence intervals will be estimated by analysis of covariance adjusted for the following allocation factors: HbA1c (EMBLEM is the first trial to assess the effect of empagliflozin on endothelial function in patients with T2DM and established CVD. Additionally, mechanisms associating

Mom’s Hut,A Restful Harbor

Institute of Scientific and Technical Information of China (English)

JENNIFER LIM

1996-01-01

I have become very fond of returning to my own parents’ home, and to my mother’s side, ever since I was 30. When I am tired of life in the noisy city and being a mother and wife, returning to my mother’s side makes me feel like a daughter again. There I am free from worries and can enjoy the tender care and love of my mother. In the morning, lying in bed lazily in the most comfortable posture, I do not need to urge my son to get up for school. The clatter Mother makes when she goes to the kitchen to prepare breakfast is the

Detecting hidden sources-STUK/HUT team

Energy Technology Data Exchange (ETDEWEB)

Nikkinen, M.; Aarnio, P. [Helsinki Univ. of Technology, Espoo (Finland); Honkamaa, T.; Tiilikainen, H. [Finnish Centre for Radiation and Nuclear Safety, Helsinki (Finland)

1997-12-31

The task of the team was to locate and to identify hidden sources in a specified area in Padasjoki Auttoinen village. The team used AB-420 helicopter of the Finnish Frontier Guard. The team had two measuring systems: HPGe system (relative efficiency 18%) and 5`x5` NaI system. The team found two sources in real-time and additional two sources after 24 h analysis time. After the locations and characteristics of the sources were announced it was found out that altogether six sources would have been possible to find using the measured data. The total number of sources was ten. The NaI detector was good at detecting and locating the sources and HPGe was most useful in identification and calculation of the activity estimates. The following development should be made: 1) larger detectors are needed, 2) the software has to be improved. (This has been performed after the exercise) and 3) the navigation must be based on DGPS. visual navigation causes easily gaps between the flight lines and some sources may not be detected. (au).

Carborne fallout mapping - STUK/HUT team

Energy Technology Data Exchange (ETDEWEB)

Honkamaa, T.; Tiilikainen, H. [Finnish Centre for Radiation and Nuclear Safety, Helsinki (Finland); Aarnio, P.; Nikkinen, M. [Helsinki Univ. of Technology, Espoo (Finland)

1997-12-31

During the summer 1995 altogether 8,625 spectrometric and 3,108 dose-rate measurements were performed in Padasjoki Auttoinen village using carborne measuring devices. As a result {sup 137}Cs fallout and dose-rate maps were produced. The highest measured values in the test area II were 160 kBq m{sup -2} for fallout and 0.22 {mu}Sv h{sup -1} for dose-rate. One hot spot was found beside the test area (dose rate 0.31 {mu}Sv h{sup -1}). On the cultivated areas the measured count rates in {sup 137}Cs-window are three to four times lower than in the forest areas in average, indicating an altered depth profile of caesium. (au).

Carborne fallout mapping - STUK/HUT team

International Nuclear Information System (INIS)

Honkamaa, T.; Tiilikainen, H.; Aarnio, P.; Nikkinen, M.

1997-01-01

During the summer 1995 altogether 8,625 spectrometric and 3,108 dose-rate measurements were performed in Padasjoki Auttoinen village using carborne measuring devices. As a result 137 Cs fallout and dose-rate maps were produced. The highest measured values in the test area II were 160 kBq m -2 for fallout and 0.22 μSv h -1 for dose-rate. One hot spot was found beside the test area (dose rate 0.31 μSv h -1 ). On the cultivated areas the measured count rates in 137 Cs-window are three to four times lower than in the forest areas in average, indicating an altered depth profile of caesium. (au)

Carborne fallout mapping - STUK/HUT team

Energy Technology Data Exchange (ETDEWEB)

Honkamaa, T; Tiilikainen, H [Finnish Centre for Radiation and Nuclear Safety, Helsinki (Finland); Aarnio, P; Nikkinen, M [Helsinki Univ. of Technology, Espoo (Finland)

1998-12-31

During the summer 1995 altogether 8,625 spectrometric and 3,108 dose-rate measurements were performed in Padasjoki Auttoinen village using carborne measuring devices. As a result {sup 137}Cs fallout and dose-rate maps were produced. The highest measured values in the test area II were 160 kBq m{sup -2} for fallout and 0.22 {mu}Sv h{sup -1} for dose-rate. One hot spot was found beside the test area (dose rate 0.31 {mu}Sv h{sup -1}). On the cultivated areas the measured count rates in {sup 137}Cs-window are three to four times lower than in the forest areas in average, indicating an altered depth profile of caesium. (au).

Detecting hidden sources-STUK/HUT team

Energy Technology Data Exchange (ETDEWEB)

Nikkinen, M; Aarnio, P [Helsinki Univ. of Technology, Espoo (Finland); Honkamaa, T; Tiilikainen, H [Finnish Centre for Radiation and Nuclear Safety, Helsinki (Finland)

1998-12-31

The task of the team was to locate and to identify hidden sources in a specified area in Padasjoki Auttoinen village. The team used AB-420 helicopter of the Finnish Frontier Guard. The team had two measuring systems: HPGe system (relative efficiency 18%) and 5`x5` NaI system. The team found two sources in real-time and additional two sources after 24 h analysis time. After the locations and characteristics of the sources were announced it was found out that altogether six sources would have been possible to find using the measured data. The total number of sources was ten. The NaI detector was good at detecting and locating the sources and HPGe was most useful in identification and calculation of the activity estimates. The following development should be made: 1) larger detectors are needed, 2) the software has to be improved. (This has been performed after the exercise) and 3) the navigation must be based on DGPS. visual navigation causes easily gaps between the flight lines and some sources may not be detected. (au).

UKRAINIAN HUT - RETURN TO THE HISTORY

Directory of Open Access Journals (Sweden)

BABENKO V. A.

2016-06-01

Full Text Available Formulation of the problem. Today's generation of young people is at the crossroads of different ages, outlooks, in transition between past and future. It is very difficult to find their identity in the modern world, find themselves in time and history ... The transfer of national experience of each state, attracting traditions, norms and values of each people to cultural and historical treasure of the world has always been, is and will be the most important functions of education in the historical development mankind. Collective monograph "History and tradition hatobuduvannya Ukrainian Dnipro region" is a significant step in achieving this primary function of education. This work, with which you can solve important tasks now facing the humanitarian academic disciplines such as help the young person understand the most important humanistic values and traditions of our society; promote understanding of the nature of social and interpersonal relations, their sociocultural and other aspects; orient students to study subjects that form in their understanding of the identity of the individual, helping to master a certain amount of knowledge that underlie the formation of personal citizenship. Analysis of previous publications. Detection of the social nature and essence of tradition and history ukrayinskohonarodnohozhytla, its role and place in society, correlation and mechanism of succession as a prerequisite for social progress, dedicated work Voropay A., G. Chubinskogo Bulasheva A., H. Wolf, V.Voytovych [ 3; 6; 1; 2; 4] and other scientists. The authors gathered economically Ukrainian traditions prevailing among the people for many centuries the lives of our ancestors. Modern scholars A. Danyluk, V. Samoilovych, Mr. Yurchenko [5; 7] and highlighted the continued use of Ukrainian traditions in hatno-commercial construction. Nevertheless there are very few developments relating to such influential in economic and industrial terms, the region as the Dnieper region. Conclusions. Having the honor to participate at least in a way this is extremely important and profound book about Ukraine and Ukrainians want to complete their review of our words of prominent Ukrainian historian and culture expert Miroslav Popovich: "... Ukraine makes people not blood and earth. Ukraine makes them and the culture in which they are involved ... Ukraine - people who maintain and develop from generation to generation certain standard of living, values and norms, life and culture ... Buildings, books, music, live only when they read, perceive understand. What a huge and bottomless that dumb us the walls of ancient monasteries and pages of new and old books - silent until we find the key to understanding and empathy - all that is a national culture, without which callous earth and stranger blood ... options accident and loss of values lot revival only one option. This careful preservation of all that served in our history, truth, goodness and beauty. "

BCG+MMC trial: adding mitomycin C to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer: a randomised phase III trial (ANZUP 1301)

International Nuclear Information System (INIS)

Hayne, Dickon; Stockler, Martin; McCombie, Steve P.; Chalasani, Venu; Long, Anne; Martin, Andrew; Sengupta, Shomik; Davis, Ian D.

2015-01-01

Despite adequate trans-urethral resection of the bladder tumour (TURBT), non-muscle-invasive bladder cancer (NMIBC) is associated with high rates of recurrence and progression. Instillation of Bacillus Calmette-Guérin (BCG) into the urinary bladder after TURBT (adjuvant intravesical administration) reduces the risk of both recurrence and progression, and this is therefore the standard of care for high-risk tumours. However, over 30 % of people still recur or progress despite optimal delivery of BCG. Our meta-analysis suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both mitomycin and BCG. These promising findings require corroboration in a definitive, large scale, randomised phase III trial using standard techniques for intravesical administration. The BCG + MMC trial (ANZUP 1301) is an open-label, randomised, stratified, two-arm multi-centre phase III trial comparing the efficacy and safety of standard intravesical therapy (BCG alone) against experimental intravesical therapy (BCG and mitomycin) in the treatment of adults with resected, high-risk NMIBC. Participants in the control group receive standard treatment with induction (weekly BCG for six weeks) followed by maintenance (four-weekly BCG for ten months). Participants in the experimental group receive induction (BCG weeks 1, 2, 4, 5, 7, and 8; mitomycin weeks 3, 6, and 9) followed by four-weekly maintenance (mitomycin weeks 13, 17, 25, 29, 37, and 41; BCG weeks 21, 33, and 45). The trial aims to include 500 participants who will be centrally randomised to one of the two treatment groups in a 1:1 ratio stratified by T-stage, presence of CIS, and study site. The primary endpoint is disease-free survival; secondary endpoints are disease activity, time to recurrence, time to progression, safety, health-related quality of life, overall survival, feasibility, and resource use

Methods and design of a 10-week multi-component family meals intervention: a two group quasi-experimental effectiveness trial.

Science.gov (United States)

Rogers, Catherine; Anderson, Sarah E; Dollahite, Jamie S; Hill, Tisa F; Holloman, Chris; Miller, Carla K; Pratt, Keeley J; Gunther, Carolyn

2017-01-09

Given the ongoing childhood obesity public health crisis and potential protective effect of family meals, there is need for additional family meals research, specifically experimental studies with expanded health outcomes that focus on the at-risk populations in highest need of intervention. Future research, specifically intervention work, would also benefit from an expansion of the target age range to include younger children, who are laying the foundation of their eating patterns and capable of participating in family meal preparations. The purpose of this paper is to address this research gap by presenting the objectives and research methods of a 10-week multi-component family meals intervention study aimed at eliciting positive changes in child diet and weight status. This will be a group quasi-experimental trial with staggered cohort design. Data will be collected via direct measure and questionnaires at baseline, intervention completion (or waiting period for controls), and 10-weeks post-intervention. Setting will be faith-based community center. Participants will be 60 underserved families with at least 1, 4-10 year old child will be recruited and enrolled in the intervention (n = 30) or waitlist control group (n = 30). The intervention (Simple Suppers) is a 10-week family meals program designed for underserved families from racial/ethnic diverse backgrounds. The 10, 90-min program lessons will be delivered weekly over the dinner hour. Session components include: a) interactive group discussion of strategies to overcome family meal barriers, plus weekly goal setting for caregivers; b) engagement in age-appropriate food preparation activities for children; and c) group family meal for caregivers and children. Main outcome measures are change in: child diet quality; child standardized body mass index; and frequency of family meals. Regression models will be used to compare response variables results of intervention to control group, controlling for

Clinical Trials

Medline Plus

Full Text Available ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Clinical trials for children have the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ...

Clinical Trials

Medline Plus

Full Text Available ... give permission for their child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Find a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

Managing clinical trials

Directory of Open Access Journals (Sweden)

Kenyon Sara

2010-07-01

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

Single-Trial Evoked Potential Estimating Based on Sparse Coding under Impulsive Noise Environment

Directory of Open Access Journals (Sweden)

Nannan Yu

2018-01-01

Full Text Available Estimating single-trial evoked potentials (EPs corrupted by the spontaneous electroencephalogram (EEG can be regarded as signal denoising problem. Sparse coding has significant success in signal denoising and EPs have been proven to have strong sparsity over an appropriate dictionary. In sparse coding, the noise generally is considered to be a Gaussian random process. However, some studies have shown that the background noise in EPs may present an impulsive characteristic which is far from Gaussian but suitable to be modeled by the α-stable distribution 1<α≤2. Consequently, the performances of general sparse coding will degrade or even fail. In view of this, we present a new sparse coding algorithm using p-norm optimization in single-trial EPs estimating. The algorithm can track the underlying EPs corrupted by α-stable distribution noise, trial-by-trial, without the need to estimate the α value. Simulations and experiments on human visual evoked potentials and event-related potentials are carried out to examine the performance of the proposed approach. Experimental results show that the proposed method is effective in estimating single-trial EPs under impulsive noise environment.

Clinical Trials

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Full Text Available ... more screening tests to see which test produces the best results. Some companies and groups sponsor clinical trials that test the ... and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

Public titles of clinical trials should have ethics review.

Science.gov (United States)

Saenz, Carla; Reveiz, Ludovic; Tisdale, John F

2015-09-01

A key aspect to guarantee that research with human subjects is ethical is being overlooked. Ethics review committees invest great effort examining the informed consent documents of research protocols to ensure that potential participants can provide consent validly and are not deluded into thinking that the experimental intervention they may sign up for is already known to be therapeutic. However, these efforts to avoid what is called the "therapeutic misconception" might be in vain if the title with which the studies are being introduced to the potential participants escapes ethics review. Research participants might be deceived by clinical trials entitled "novel therapy" when the point of the trial is precisely to find out whether the intervention at stake is therapeutic or not. Providing potential research participants with such misleading information hampers their ability to make informed decisions. The well-established scrutiny that ethics review committees exercise with regard to consent forms is limited if the registration of clinical trials, for which a public title is chosen, constitutes a process that is independent from the ethics review. In this article, we examine this problem, assess recent measures to integrate clinical trial registration with ethics review processes, and provide specific recommendations to solve the problem and ultimately enhance the accountability, transparency, and ethics of research with human subjects. Copyright © 2015 Pan American Health Organization. Published by Elsevier Inc. All rights reserved.

Initiation of a phase-I trial of neutron capture therapy at the MIT research reactor

International Nuclear Information System (INIS)

Harling, O.K.; Bernard, J.A.; Yam, Chun-Shan

1995-01-01

The Massachusetts Institute of Technology (MIT), the New England Medical Center (NEMC), and Boston University Medical Center (BUMC) initiated a phase-1 trial of boron neutron capture therapy (BNCT) on September 6, 1994, at the 5-MW(thermal) MIT research reactor (MITR). A novel form of experimental cancer therapy, BNCT is being developed for certain types of highly malignant brain tumors such as glioblastoma and melanoma. The results of the phase-1 trials on patients with tumors in the legs or feet are described

A cluster-randomised trial of a multifaceted quality improvement intervention in Brazilian intensive care units (Checklist-ICU trial): statistical analysis plan.

Science.gov (United States)

Damiani, Lucas P; Cavalcanti, Alexandre B; Moreira, Frederico R; Machado, Flavia; Bozza, Fernando A; Salluh, Jorge I F; Campagnucci, Valquiria P; Normilio-Silva, Karina; Chiattone, Viviane C; Angus, Derek C; Berwanger, Otavio; Chou H Chang, Chung-

2015-06-01

The Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units (Checklist- ICU) trial is a pragmatic, two-arm, cluster-randomised trial involving 118 intensive care units in Brazil, with the primary objective of determining if a multifaceted qualityimprovement intervention with a daily checklist, definition of daily care goals during multidisciplinary daily rounds and clinician prompts can reduce inhospital mortality. To describe our trial statistical analysis plan (SAP). This is an ongoing trial conducted in two phases. In the preparatory observational phase, we collect three sets of baseline data: ICU characteristics; patient characteristics, processes of care and outcomes; and completed safety attitudes questionnaires (SAQs). In the randomised phase, ICUs are assigned to the experimental or control arms and we collect patient data and repeat the SAQ. Our SAP includes the prespecified model for the primary and secondary outcome analyses, which account for the cluster-randomised design and availability of baseline data. We also detail the multiple mediation models that we will use to assess our secondary hypothesis (that the effect of the intervention on inhospital mortality is mediated not only through care processes targeted by the checklist, but also through changes in safety culture). We describe our approach to sensitivity and subgroup analyses and missing data. We report our SAP before closing our study database and starting analysis. We anticipate that this should prevent analysis bias and enhance the utility of results.

The Veterinary Clinical Trials Network - a Pragmatic Approach to Filling the Evidence Gaps for Veterinary Practice

Directory of Open Access Journals (Sweden)

Hannah Doit

2017-04-01

Full Text Available Including current published evidence is vital as part of evidence-based decision making in veterinary practice. Sometimes there is no published evidence which is relevant or applicable to the clinical situation.This can be either because it refers to patients with experimentally induced conditions, from a referral population or who lack the co-morbities often seen outside of the experimental context. The Veterinary Clinical Trials Network is unique. It is a rapidly expanding network of veterinary practices, with whom we are working to establish methods for running prospective, pragmatic, practical clinical trials in veterinary practice.Data is extracted from the patient record using an XML Schema. The data extracted is already captured by the Practice Management Software (PMS system as part of the consultation, no extra information is required, and the extraction method is automated. This improves participation as it minimises the time input required from vets and vet nurses. Other data is obtained directly from owners of the animals involved.By working with a large number of first opinion veterinary practices we are able to include enough patients to ensure that our trials are suitably powered, and the participants will be representative of the wider vet-visiting pet population. The research generated from this clinical trials network will help strengthen the evidence base to aid decision making by veterinary practitioners.

Lessons learned using HAMMLAB experimenter systems: Input for HAMMLAB 2000 functional requirements

International Nuclear Information System (INIS)

Sebok, Angelia L.

1998-02-01

To design a usable HAMMLAB 2000, lessons learned from use of the existing HAMMLAB must be documented. User suggestions are important and must be taken into account. Different roles in HAMMLAB experimental sessions are identified, and major functions of each role were specified. A series of questionnaires were developed and administered to different users of HAMMLAB, each tailored to the individual job description. The results of those questionnaires are included in this report. Previous HAMMLAB modification recommendations were also reviewed, to provide input to this document. A trial experimental session was also conducted, to give an overview of the tasks in HAMMLAB. (author)

Chasing red herrings: Memory of distractors causes fixation in creative problem solving.

Science.gov (United States)

Beda, Zsolt; Smith, Steven M

2018-03-07

Two experiments tested the red herring retrieval hypothesis, which states that fixation in creative problem solving is worse when memory for red herrings (i.e., inappropriate or incorrect solutions) is strengthened. In Experiment 1, when associations between Remote Associates Test (RAT) problem words (e.g., COTTAGE, SWISS, CAKE) and related red herring words (e.g., hut, chocolate, icing) were strengthened via repetition, an encoding variable, fixation was found to increase. In Experiment 2, when associations were formed between RAT problem contexts and red herrings, then subsequent reinstatement of problem contexts during RAT problem solving trials (as compared with showing new contexts) also worsened fixation effects. Our results add to the increasing body of research that connects memory with creative problem solving, and they suggest possible ways for overcoming fixation effects.

Clinical Trials

Medline Plus

Full Text Available ... resources to the strategies and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking part in a clinical trial is different ...

Current Evidence to Justify, and the Methodological Considerations for a Randomised Controlled Trial Testing the Hypothesis that Statins Prevent the Malignant Progression of Barrett's Oesophagus

Directory of Open Access Journals (Sweden)

David Thurtle

2014-12-01

Full Text Available Barrett’s oesophagus is the predominant risk factor for oesophageal adenocarcinoma, a cancer whose incidence is increasing and which has a poor prognosis. This article reviews the latest experimental and epidemiological evidence justifying the development of a randomised controlled trial investigating the hypothesis that statins prevent the malignant progression of Barrett’s oesophagus, and explores the methodological considerations for such a trial. The experimental evidence suggests anti-carcinogenic properties of statins on oesophageal cancer cell lines, based on the inhibition of the mevalonate pathway and the production of pro-apoptotic proteins. The epidemiological evidence reports inverse associations between statin use and the incidence of oesophageal carcinoma in both general population and Barrett’s oesophagus cohorts. Such a randomised controlled trial would be a large multi-centre trial, probably investigating simvastatin, given the wide clinical experience with this drug, relatively low side-effect profile and low financial cost. As with any clinical trial, high adherence is important, which could be increased with therapy, patient, doctor and system-focussed interventions. We would suggest there is now sufficient evidence to justify a full clinical trial that attempts to prevent this aggressive cancer in a high-risk population.

Microscopic model for the non-linear fluctuating hydrodynamic of 4 He superfluid helium deduced by maximum entropy method

International Nuclear Information System (INIS)

Alvarez R, J.T.

1998-01-01

This thesis presents a microscopic model for the non-linear fluctuating hydrodynamic of superfluid helium ( 4 He), model developed by means of the Maximum Entropy Method (Maxent). In the chapter 1, it is demonstrated the necessity to developing a microscopic model for the fluctuating hydrodynamic of the superfluid helium, starting from to show a brief overview of the theories and experiments developed in order to explain the behavior of the superfluid helium. On the other hand, it is presented the Morozov heuristic method for the construction of the non-linear hydrodynamic fluctuating of simple fluid. Method that will be generalized for the construction of the non-linear fluctuating hydrodynamic of the superfluid helium. Besides, it is presented a brief summary of the content of the thesis. In the chapter 2, it is reproduced the construction of a Generalized Fokker-Planck equation, (GFP), for a distribution function associated with the coarse grained variables. Function defined with aid of a nonequilibrium statistical operator ρhut FP that is evaluated as Wigneris function through ρ CG obtained by Maxent. Later this equation of GFP is reduced to a non-linear local FP equation from considering a slow and Markov process in the coarse grained variables. In this equation appears a matrix D mn defined with a nonequilibrium coarse grained statistical operator ρhut CG , matrix elements are used in the construction of the non-linear fluctuating hydrodynamics equations of the superfluid helium. In the chapter 3, the Lagrange multipliers are evaluated for to determine ρhut CG by means of the local equilibrium statistical operator ρhut l -tilde with the hypothesis that the system presents small fluctuations. Also are determined the currents associated with the coarse grained variables and furthermore are evaluated the matrix elements D mn but with aid of a quasi equilibrium statistical operator ρhut qe instead of the local equilibrium operator ρhut l -tilde. Matrix

Clinical trials of homoeopathy.

Science.gov (United States)

Kleijnen, J; Knipschild, P; ter Riet, G

1991-01-01

OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

Clinical Trials

Medline Plus

Full Text Available ... about your health or fill out forms about how you feel. Some people will need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in Bethesda, Maryland, runs clinical trials. Many other clinical trials take place ...

Clinical Trials

Medline Plus

Full Text Available ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment options. Together, you can make the ... more about, or taking part in, clinical trials, talk with your doctor. He or she may know about ... clinical trials. NIH Clinical Research Studies ...

A systematic review of estrogens for recurrent urinary tract infections: third report of the hormones and urogenital therapy (HUT) committee.

Science.gov (United States)

Cardozo, L; Lose, G; McClish, D; Versi, E; de Koning Gans, H

2001-01-01

Our objective was to apply a meta-analysis to the available data to evaluate the effect of estrogen supplementation in the prevention of recurrent urinary tract infections in postmenopausal women. The literature review incorporated articles based on a search of Excerpta Medica, Medline, Science Citation Index and a manual search of commonly read journals in the fields of urology, gynecology, gerontology and primary healthcare, from January 1969 to December 1998. The search was not limited to English-language publications. Inclusion criteria were peer-reviewed articles containing original data with a primary outcome of symptomatic urinary tract infections and an estrogen-treated group. Articles were categorized into randomized controlled trials, case-control studies and self-controlled series. Of the articles reviewed, five were randomized controlled trials, two were case-control studies and three were self-control series. Meta-analysis of data from 334 subjects revealed a significant benefit from estrogen over placebo (odds ratio = 2.51, 95% confidence interval = 1.48 4.25). The most convincing results were obtained using the vaginal route of administration. A variety of different estrogen preparations have been employed in the few published reports, making comparison of the data difficult. However, vaginal administration seems to be effective in the prevention of recurrent urinary tract infections in postmenopausal women.

Training Head Start Teachers to Conduct Trial-Based Functional Analysis of Challenging Behavior

Science.gov (United States)

Rispoli, Mandy; Burke, Mack D.; Hatton, Heather; Ninci, Jennifer; Zaini, Samar; Sanchez, Lisa

2015-01-01

Trial-based functional analysis (TBFA) is a procedure for experimentally identifying the function of challenging behavior within applied settings. The purpose of this study was to examine the effects of a TBFA teacher-training package in the context of two Head Start centers implementing programwide positive behavior support (PWPBS). Four Head…

Testing a Violence-Prevention Intervention for Incarcerated Women Using a Randomized Control Trial

Science.gov (United States)

Kubiak, Sheryl Pimlott; Kim, Woo Jong; Fedock, Gina; Bybee, Deborah

2015-01-01

Objective: Beyond Violence (BV), a new prevention program for women with assaultive offenses, demonstrated feasibility in previous studies. This study's purpose is to assess the efficacy of BV using a randomized control trial. Method: Eligible women were randomly assigned to treatment as usual (TAU) and the experimental condition (BV). Measures of…

Quasi-experimental study designs series-paper 4: uses and value.

Science.gov (United States)

Bärnighausen, Till; Tugwell, Peter; Røttingen, John-Arne; Shemilt, Ian; Rockers, Peter; Geldsetzer, Pascal; Lavis, John; Grimshaw, Jeremy; Daniels, Karen; Brown, Annette; Bor, Jacob; Tanner, Jeffery; Rashidian, Arash; Barreto, Mauricio; Vollmer, Sebastian; Atun, Rifat

2017-09-01

Quasi-experimental studies are increasingly used to establish causal relationships in epidemiology and health systems research. Quasi-experimental studies offer important opportunities to increase and improve evidence on causal effects: (1) they can generate causal evidence when randomized controlled trials are impossible; (2) they typically generate causal evidence with a high degree of external validity; (3) they avoid the threats to internal validity that arise when participants in nonblinded experiments change their behavior in response to the experimental assignment to either intervention or control arm (such as compensatory rivalry or resentful demoralization); (4) they are often well suited to generate causal evidence on long-term health outcomes of an intervention, as well as nonhealth outcomes such as economic and social consequences; and (5) they can often generate evidence faster and at lower cost than experiments and other intervention studies. Copyright © 2017 Elsevier Inc. All rights reserved.

Primary infection protects pigs against re-infection with Lawsonia intracellularis in experimental challenge studies

DEFF Research Database (Denmark)

Riber, Ulla; Hvass, Henriette Cordes; Boutrup, Torsten Snogdal

2011-01-01

In two separate trials previous termpigsnext term were experimentally infected with previous termLawsonia intracellularisnext term at 5–6 weeks of age followed by antibiotic treatment and resolution of the previous termprimary infection and then renext term-inoculated at 12–13 weeks of age. A tre...

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

Science.gov (United States)

Lamb, S E; Williams, M A; Williamson, E M; Gates, S; Withers, E J; Mt-Isa, S; Ashby, D; Castelnuovo, E; Underwood, M; Cooke, M W

2012-01-01

To examine the clinical effectiveness of a stepped care approach over a 12-month period after an acute whiplash injury; to estimate the costs and cost-effectiveness of each strategy including treatments and subsequent health-care costs; and to gain participants' perspective on experiencing whiplash injury, NHS treatment, and recovery within the context of the Managing Injuries of the Neck Trial (MINT). Two linked, pragmatic, randomised controlled trials. In Step 1, emergency departments (EDs) were cluster randomised to usual care advice (UCA) or The Whiplash Book advice (WBA)/active management advice. In Step 2, participants were individually randomised to either a single session of advice from a physiotherapist or a physiotherapy package of up to six sessions. An economic evaluation and qualitative study were run in parallel with the trial. Twelve NHS trusts in England comprising 15 EDs. People who attended EDs with an acute whiplash injury of whiplash-associated disorder grades I-III were eligible for Step 1. People who had attended EDs with whiplash injuries and had persistent symptoms 3 weeks after ED attendance were eligible for Step 2. In Step 1, the control intervention was UCA and the experimental intervention was a psycho-educational intervention (WBA/active management advice). In Step 2 the control treatment was reinforcement of the advice provided in Step 1 and the experimental intervention was a package of up to six physiotherapy treatments. The primary outcome was the Neck Disability Index (NDI), which measures severity and frequency of pain and symptoms, and a range of activities including self-care, driving, reading, sleeping and recreation. Secondary outcomes included the mental and physical health-related quality-of-life (HRQoL) subscales of the Short Form questionnaire-12 items (SF-12) and the number of work days lost. A total of 3851 patients were recruited to Step 1 of the trial. 1598 patients attending EDs were randomised to UCA, and 2253 were

ORCHIDS: an Observational Randomized Controlled Trial on Childhood Differential Susceptibility

Directory of Open Access Journals (Sweden)

Chhangur Rabia R

2012-10-01

Full Text Available Abstract Background A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children’s development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes. However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-environment interactions to obtain more insight into a moderating effects of polymorphisms on the link between parenting and child behavior, and b behavioral mechanisms that underlie these gene-(gene-environment interactions in an experimental design. Methods/Design The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training. In a screening, families with children aged 4–8 who show mild to (subclinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest, after 6 months (i.e., posttest, and after 10 months (i.e., follow-up. Discussion This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and

The influence of anti-infective periodontal treatment on C-reactive protein: a systematic review and meta-analysis of randomized controlled trials.

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Ryan T Demmer

Full Text Available Periodontal infections are hypothesized to increase the risk of adverse systemic outcomes through inflammatory mechanisms. The magnitude of effect, if any, of anti-infective periodontal treatment on systemic inflammation is unknown, as are the patient populations most likely to benefit. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs to test the hypothesis that anti-infective periodontal treatment reduces systemic c-reactive protein (CRP.MEDLINE, EMBASE, CENTRAL and CINAHL databases were searched using sensitivity-enhancing search terms. Eligible RCTs enrolled patients with periodontal infection, compared a clearly defined anti-infective periodontal intervention (experimental group to an "inactive control" (no periodontal intervention or to an "active control" (lower treatment intensity than the experimental group. Mean differences in final CRP values at the earliest post-treatment time point (typically 1-3 months between experimental and control groups were analyzed using random-effects regression. Among 2,753 possible studies 20 were selected, which included 2,561 randomized patients(median=57. Baseline CRP values were >3.0 mg/L in 40% of trials. Among studies with a control group receiving no treatment, the mean difference in CRP final values among experimental treatment vs. control groups was -0.37 mg/L [95%CI=-0.64, -0.11], (P=0.005, favoring experimental treatment. Trials for which the experimental group received antibiotics had stronger effects (P for interaction=0.03 and the mean difference in CRP final values among experimental treatment vs. control was -0.75 mg/L [95%CI=-1.17,-0.33]. No treatment effect was observed among studies using an active treatment comparator. Treatment effects were stronger for studies that included patients with co-morbidities vs. studies that included "systemically healthy" patients, although the interaction was not significant (P=0.48.Anti-infective periodontal

Blood pressure and heart rate variability analysis of orthostatic challenge in normal human pregnancies.

Science.gov (United States)

Heiskanen, Nonna; Saarelainen, Heli; Valtonen, Pirjo; Lyyra-Laitinen, Tiina; Laitinen, Tomi; Vanninen, Esko; Heinonen, Seppo

2008-11-01

The aim of the present study was to evaluate pregnancy-related changes in autonomic regulatory functions in healthy subjects. We studied cardiovascular autonomic responses to head-up tilt (HUT) in 28 pregnant women during the third trimester of pregnancy and 3 months after parturition. The maternal ECG and non-invasive beat-to-beat blood pressure were recorded in the horizontal position (left-lateral position) and during HUT in the upright position. Stroke volume was assessed from blood pressure signal by using the arterial pulse contour method. Heart rate variability (HRV) was analysed in frequency domain, and baroreflex sensitivity by the cross-spectral and the sequence methods. In the horizontal position, all frequency components of HRV were lower during pregnancy than 3 months after parturition (P pregnancy had no influence on normalized low frequency and high frequency powers. During pregnancy haemodynamics was well balanced with only minor changes in response to postural change while haemodynamic responses to HUT were more remarkable after parturition. In pregnant women HRV and especially its very low frequency component increased in response to HUT, whereas at 3 months after parturition the direction of these changes was opposite. Parasympathetic deactivation towards term is likely to contribute to increased heart rate and cardiac output at rest, whereas restored sympathetic modulation with modest responses may contribute stable peripheral resistance and sufficient placental blood supply under stimulated conditions. It is important to understand cardiovascular autonomic nervous system and haemodynamic control in normal pregnancy before being able to judge whether they are dysregulated in complicated pregnancies.

Toe blood pressure and leg muscle oxygenation with body posture.

Science.gov (United States)

Rosales-Velderrain, Armando; Cardno, Michael; Mateus, Jaime; Kumar, Ravindra; Schlabs, Thomas; Hargens, Alan R

2011-05-01

In 1980 Katkov and Chestukhin measured blood pressures and oxygenation invasively at various body tilt angles at different locations on the body, including the foot. To our knowledge, such measurements have not been performed noninvasively. Therefore, the purpose of this study was to measure toe blood pressure (TBP) and lower limb muscle oxygenation noninvasively at various body tilt angles, and to assess the use of a Finometer for noninvasive TBP measurements. Our noninvasive results are compared with those performed by Katkov and Chestukhin. We hypothesized that: 1) the Finometer provides a noninvasive measurement of TBP at different tilt angles; and 2) muscle oxygenation is highest with 0 and -6 degrees, and decreases with increased head-up tilt (HUT). There were 10 subjects who were exposed to different body tilt angles (-6, 0, 10, 30, 70, and 90 degrees). At each angle we measured TBP noninvasively with a Finometer and muscle tissue oxygenation by near infrared spectroscopy. We found a strong correlation between TBP using the Finometer and TBP predicted by adding the hydrostatic component due to body tilt to the standard arm blood pressure measurement. At 10, 30, 70, and 90 degrees both TBP and tissue oxygenation were significantly different from the 0 degree (supine) level. Oxygenation decreased and TBP increased with higher HUT angles. No differences were observed in TBP or oxygenation between -6 and 0 degree. The Finometer accurately measures TBP noninvasively with body tilt. Also, muscle oxygenation is highest at small HUT angles and decreases with increased HUT.

[Experimental study on acid mine drainage treatment using mine tailings of Xiangsi Valley, Tongling, China].

Science.gov (United States)

Zhang, Nan; Chen, Tian-Hu; Zhou, Yue-Fei; Li, Shao-Jie; Jin, Jie; Wang, Yan-Ming

2012-04-01

Mine tailings in Xiangsi Valley, Tongling, China, is a typical skarn-type tailing with high contents of carbonates. This study designed dynamic leaching experiments to investigate the efficiency of this tailing under the acid mine drainage treatment. During 80 d trial period, the physical and chemical properties of influents were fixed and the effluents were monitored. After the trial, the speciation of Fe, Cu and Zn in solid was analyzed. The results showed that during the trial period, pH value maintained above 7.5. Moreover, the concentrations of Cu, Zn, Fe ions in effluents kept below 0.1, 0.4 and 1 mg x L(-1), respectively. In addition, the permeability coefficient of experimental column kept decreasing during the experimental period (from 0.23 cm x s(-1) to 0.10 cm x s(-1)). Five-step sequential extraction method was employed to study the distribution of elements at different depths. The results showed that Cu2+, Zn2+ were removed mainly through sorption and precipitation. This study indicates that Tongling skarn mine tailings have strong acid neutralization as well as heavy metal binding capacities. Therefore, the authors suggest that this mine tailing, which used to be waste, has a potential in AMD control and treatment.

Trigger effect of infrared femtosecond laser irradiation on neoplasm in experimental cervical cancer

Science.gov (United States)

Gening, Tatyana; Voronova, Olga; Zolotovskii, Igor; Sysoliatin, Alexey; Dolgova, Dinara; Abakumova, Tatyana

2013-02-01

The present work discusses effect of infrared (IR) femtosecond laser irradiation on neoplasm of white mice with experimental cervical cancer- 5 (CC-5 on the 20th and 30th days after tumor transplantation). Tumor tissue was irradiated by femtosecond erbium doped fiber laser: the wavelength is 1.55 μm, average and peak powers are1,25 mW and 6kW, respectively, irradiation trials n=10. The average energy density (energy dose) on a tissue for two groups of animals was 0,24 J/cm2 and 0,36 J/cm2 for a single trial. Irradiation was followed by biochemical determination of LPO AOS parameters ("Lipid peroxidation-antioxidants" system): malondialdehyde (MDA), activity of superoxide dismutase (SOD), catalase and glutathione-reductase (GR), glutathione-S-transferase (GST). A subsequent morphological study of tumor tissue was performed. Mathematical analysis of data demonstrates a weak dependence of the studied parameters on energy dose. The latter implies the trigger effect of IR femtosecond laser irradiation on redox-dependent processes in neoplasm at experimental cervical cancer.

A randomised controlled trial evaluating family mediated exercise (FAME therapy following stroke

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Stokes Emma

2008-06-01

Full Text Available Abstract Background Stroke is a leading cause of disability among adults worldwide. Evidence suggests that increased duration of exercise therapy following stroke has a positive impact on functional outcome following stroke. The main objective of this randomised controlled trial is to evaluate the impact of additional family assisted exercise therapy in people with acute stroke. Methods/Design A prospective multi-centre single blind randomised controlled trial will be conducted. Forty patients with acute stroke will be randomised into either an experimental or control group. The experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The control group will receive routine therapy with no additional formal input from their family members. Participants will be assessed at baseline, post intervention and followed up at three months using a series of standardised outcome measures. A secondary aim of the project is to evaluate the impact of the family mediated exercise programme on the person with stroke and the individual(s assisting in the delivery of exercises using a qualitative methodology. The study has gained ethical approval from the Research Ethics Committees of each of the clinical sites involved in the study. Discussion This study will evaluate a structured programme of exercises that can be delivered to people with stroke by their 'family members/friends'. Given that the progressive increase in the population of older people is likely to lead to an increased prevalence of stroke in the future, it is important to reduce the burden of this illness on the individual, the family and society. Family mediated exercises can maximise the carry over outside formal physiotherapy sessions, giving patients the opportunity for informal practice. Trial Registration The protocol for this study is registered with the US NIH Clinical trials registry (NCT00666744

MDM2 inhibitor nutlin-3a induces apoptosis and senescence in cutaneous T-cell lymphoma: Role of p53

DEFF Research Database (Denmark)

Manfé, Valentina; Biskup, Edyta Urszula; Johansen, Peter

2012-01-01

cell lines, P53 mutation analysis identified a homozygous nonsense mutation (R196Stop in Hut-78) and a homozygous missense mutation (G245S in SeAx). In MyLa2000, Mac1, and Mac2a carrying wild-type P53, nutlin-3a induced apoptosis and senescence demonstrated by permanent G0/G1 cell-cycle block...... with intact p53 but also in Hut-78, SeAx, and Sézary cells. Thus, targeting p53 by nutlin-3a may constitute a therapeutic approach in CTCL because of increased apoptosis and senescence of tumor cells....

Using simulation to aid trial design: Ring-vaccination trials.

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Matt David Thomas Hitchings

2017-03-01

Full Text Available The 2014-6 West African Ebola epidemic highlights the need for rigorous, rapid clinical trial methods for vaccines. A challenge for trial design is making sample size calculations based on incidence within the trial, total vaccine effect, and intracluster correlation, when these parameters are uncertain in the presence of indirect effects of vaccination.We present a stochastic, compartmental model for a ring vaccination trial. After identification of an index case, a ring of contacts is recruited and either vaccinated immediately or after 21 days. The primary outcome of the trial is total vaccine effect, counting cases only from a pre-specified window in which the immediate arm is assumed to be fully protected and the delayed arm is not protected. Simulation results are used to calculate necessary sample size and estimated vaccine effect. Under baseline assumptions about vaccine properties, monthly incidence in unvaccinated rings and trial design, a standard sample-size calculation neglecting dynamic effects estimated that 7,100 participants would be needed to achieve 80% power to detect a difference in attack rate between arms, while incorporating dynamic considerations in the model increased the estimate to 8,900. This approach replaces assumptions about parameters at the ring level with assumptions about disease dynamics and vaccine characteristics at the individual level, so within this framework we were able to describe the sensitivity of the trial power and estimated effect to various parameters. We found that both of these quantities are sensitive to properties of the vaccine, to setting-specific parameters over which investigators have little control, and to parameters that are determined by the study design.Incorporating simulation into the trial design process can improve robustness of sample size calculations. For this specific trial design, vaccine effectiveness depends on properties of the ring vaccination design and on the

Experimental knee pain evoke spreading hyperalgesia and facilitated temporal summation of pain

DEFF Research Database (Denmark)

Jørgensen, Tanja Schjødt; Henriksen, Marius; Danneskiold-Samsøe, Bente

2013-01-01

OBJECTIVES: This study evaluated the deep-tissue pressure pain sensitivity and temporal summation of pain within and around healthy knees exposed to experimental pain. DESIGN: The study was designed as a randomized crossover trial, with each subject tested on 1 day. SETTING: All tests were carried...... occasions: baseline, immediately after the injection, and when pain had vanished. Assessments sites were located in the peripatellar region, vastus lateralis, and tibialis anterior muscles. RESULTS: The experimental knee pain model demonstrated 1) hyperalgesia to pressure stimulation on the infrapatellar...... fat pad during experimental pain, and 2) facilitated temporal summation of pressure pain at the infrapatellar fat pad and knee-related muscles. CONCLUSION: The increased sensitivity and temporal summation found in this study were exclusive to deep -tissue with no contralateral decreased pain...

Functional exercise after total hip replacement (FEATHER a randomised control trial

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Monaghan Brenda

2012-11-01

Full Text Available Abstract Background Prolonged physical impairments in range of movement, postural stability and walking speed are commonly reported following total hip replacement (THR. It is unclear from the current body of evidence what kind of exercises should be performed to maximize patient function and quality of life. Methods/design This will be a single blind multi centre randomized control trial with two arms. Seventy subjects post primary total hip arthroplasty will be randomized into either an experimental group (n=35, or to a control group (n=35. The experimental group will attend a functional exercise class twice weekly for a six week period from week 12 to week 18 post surgery. The functional exercise group will follow a circuit based functional exercise class supervised by a chartered Physiotherapist. The control group will receive usual care. The principal investigator (BM will perform blinded outcome assessments on all patients using validated measures for pain, stiffness, and function using the Western Ontario and Mc Master Universities Osteoarthritis index (WOMAC. This is the primary outcome measurement tool. Secondary outcome measurements include Quality of life (SF-36, 6 min walk test, Visual Analogue Scale, and the Berg Balance score. The WOMAC score will be collated on day five post surgery and repeated at week twelve and week eighteen. All other measurements will be taken at week 12 and repeated at week eighteen. In addition a blinded radiologist will measure gluteus medius cross sectional area using real time ultrasound for all subjects at week 12 and at week 18 to determine if the functional exercise programme has any effect on muscle size. Discussion This randomised controlled trial will add to the body of evidence on the relationship between muscle size, functional ability, balance, quality of life and time post surgery in patients following total hip arthroplasty. The CONSORT guidelines will be followed to throughout. Ethical

Detailed statistical analysis plan for the target temperature management after out-of-hospital cardiac arrest trial

DEFF Research Database (Denmark)

Nielsen, Niklas; Winkel, Per; Cronberg, Tobias

2013-01-01

Animal experimental studies and previous randomized trials suggest an improvement in mortality and neurological function with temperature regulation to hypothermia after cardiac arrest. According to a systematic review, previous trials were small, had a risk of bias, evaluated select populations......, and did not treat hyperthermia in the control groups. The optimal target temperature management (TTM) strategy is not known. To prevent outcome reporting bias, selective reporting and data-driven results, we present the a priori defined detailed statistical analysis plan as an update to the previously...

Systemic steroid reduces long-term hearing loss in experimental pneumococcal meningitis

DEFF Research Database (Denmark)

Worsøe, Lise Lotte; Brandt, C.T.; Lund, S.P.

2010-01-01

Sensorineural hearing loss is a common complication of pneumococcal meningitis. Treatment with corticosteroids reduces inflammatory response and may thereby reduce hearing loss. However, both experimental studies and clinical trials investigating the effect of corticosteroids on hearing loss have...... generated conflicting results. The objective of the present study was to determine whether systemic steroid treatment had an effect on hearing loss and cochlear damage in a rat model of pneumococcal meningitis....

Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

Science.gov (United States)

Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

2008-12-01

Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

Science.gov (United States)

Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S; Adams, Marc A

2015-09-11

Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults' PA compared to the static intervention components. Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message-based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants' daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently active and are overweight or obese. WalkIT is one of

Inactive trials of transport systems: phase II

International Nuclear Information System (INIS)

Haberlin, M.M.; Hardy, A.R.; Kennedy, S.T.

1986-11-01

Progress made during 1984-85 is reviewed in four sections: the design and installation of a stainless steel working floor in the mock-up of a crate handling and size reduction facility; the detailed evaluation of a single air pad of the type used on commercial air-transporter; an experimental programme designed to examine the problems associated with the operation of a commercial air-transporter; the design, manufacture and commissioning trials of two powered conveyor units which when combined complete a remotely operated transfer system for transporting crated waste into and within the mock-up facility. (author)

A trial of distributed portable data acquisition and processing system implementation: the qdpb - data processing with branchpoints

International Nuclear Information System (INIS)

Gritsaj, K.I.; Isupov, A.Yu.

2001-01-01

A trial of distributed portable data acquisition and processing system qdpb is issued. An experimental setup data and hardware dependent code is separated from the generic part of the qdpb system. The generic part implementation is described

Clinical trials as treatment option: bioethics and health care disparities in substance dependency.

Science.gov (United States)

Timmermans, Stefan; McKay, Tara

2009-12-01

Bioethicists have warned against the dangers of mixing research with treatment. They are concerned that research priorities may take precedence over individual patient needs and that research subjects tend to misunderstand the purpose of research or overestimate the direct medical benefits of participating in studies. Yet, other work has questioned whether clinical research can always be separated from therapeutic benefit for participants. Using in-depth interviews with participants in two phase III randomized U.S. clinical trials for methamphetamine dependency, we examine the treatment options available to participants, their experiences with participating in the trials, and potential problems of trial participation. We find that while participants have experience with four alternative treatment modalities - quitting alone, support groups, in-patient treatment facilities, and consulting primary care physicians - the randomized clinical trials compare favorably to alternatives because they provide access to evidence-based behavioral treatments, specialized medical professionals, non-judgmental staff, and the possibility of receiving an experimental drug. We conclude that while randomized clinical trials are imperfect substitutes for clinical care, they constitute a fragile and sporadic therapeutic niche in a country with fundamental problems in access to health care, a mixed punitive-therapeutic drug addiction policy, and a profit-driven pharmaceutical development and approval process.

Decoding sequence learning from single-trial intracranial EEG in humans.

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Marzia De Lucia

Full Text Available We propose and validate a multivariate classification algorithm for characterizing changes in human intracranial electroencephalographic data (iEEG after learning motor sequences. The algorithm is based on a Hidden Markov Model (HMM that captures spatio-temporal properties of the iEEG at the level of single trials. Continuous intracranial iEEG was acquired during two sessions (one before and one after a night of sleep in two patients with depth electrodes implanted in several brain areas. They performed a visuomotor sequence (serial reaction time task, SRTT using the fingers of their non-dominant hand. Our results show that the decoding algorithm correctly classified single iEEG trials from the trained sequence as belonging to either the initial training phase (day 1, before sleep or a later consolidated phase (day 2, after sleep, whereas it failed to do so for trials belonging to a control condition (pseudo-random sequence. Accurate single-trial classification was achieved by taking advantage of the distributed pattern of neural activity. However, across all the contacts the hippocampus contributed most significantly to the classification accuracy for both patients, and one fronto-striatal contact for one patient. Together, these human intracranial findings demonstrate that a multivariate decoding approach can detect learning-related changes at the level of single-trial iEEG. Because it allows an unbiased identification of brain sites contributing to a behavioral effect (or experimental condition at the level of single subject, this approach could be usefully applied to assess the neural correlates of other complex cognitive functions in patients implanted with multiple electrodes.

Feasibility of a randomised trial of a continuing medical education program in shared decision-making on the use of antibiotics for acute respiratory infections in primary care: the DECISION+ pilot trial

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Laurier Claudine

2011-01-01

Full Text Available Abstract Background The misuse and limited effectiveness of antibiotics for acute respiratory infections (ARIs are well documented, and current approaches targeting physicians or patients to improve appropriate use have had limited effect. Shared decision-making could be a promising strategy to improve appropriate antibiotic use for ARIs, but very little is known about its implementation processes and outcomes in clinical settings. In this matter, pilot studies have played a key role in health science research over the past years in providing information for the planning, justification, and/or refinement of larger studies. The objective of our study was to assess the feasibility and acceptability of the study design, procedures, and intervention of the DECISION+ program, a continuing medical education program in shared decision-making among family physicians and their patients on the optimal use of antibiotics for treating ARIs in primary care. Methods A pilot clustered randomised trial was conducted. Family medicine groups (FMGs were randomly assigned, to either the DECISION+ program, which included three 3-hour workshops over a four- to six-month period, or a control group that had a delayed exposure to the program. Results Among 21 FMGs contacted, 5 (24% agreed to participate in the pilot study. A total of 39 family physicians (18 in the two experimental and 21 in the three control FMGs and their 544 patients consulting for an ARI were recruited. The proportion of recruited family physicians who participated in all three workshops was 46% (50% for the experimental group and 43% for the control group, and the overall mean level of satisfaction regarding the workshops was 94%. Conclusions This trial, while aiming to demonstrate the feasibility and acceptability of conducting a larger study, has identified important opportunities for improving the design of a definitive trial. This pilot trial is informative for researchers and clinicians

A machine learning approach to identify clinical trials involving nanodrugs and nanodevices from ClinicalTrials.gov.

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Diana de la Iglesia

Full Text Available Clinical Trials (CTs are essential for bridging the gap between experimental research on new drugs and their clinical application. Just like CTs for traditional drugs and biologics have helped accelerate the translation of biomedical findings into medical practice, CTs for nanodrugs and nanodevices could advance novel nanomaterials as agents for diagnosis and therapy. Although there is publicly available information about nanomedicine-related CTs, the online archiving of this information is carried out without adhering to criteria that discriminate between studies involving nanomaterials or nanotechnology-based processes (nano, and CTs that do not involve nanotechnology (non-nano. Finding out whether nanodrugs and nanodevices were involved in a study from CT summaries alone is a challenging task. At the time of writing, CTs archived in the well-known online registry ClinicalTrials.gov are not easily told apart as to whether they are nano or non-nano CTs-even when performed by domain experts, due to the lack of both a common definition for nanotechnology and of standards for reporting nanomedical experiments and results.We propose a supervised learning approach for classifying CT summaries from ClinicalTrials.gov according to whether they fall into the nano or the non-nano categories. Our method involves several stages: i extraction and manual annotation of CTs as nano vs. non-nano, ii pre-processing and automatic classification, and iii performance evaluation using several state-of-the-art classifiers under different transformations of the original dataset.The performance of the best automated classifier closely matches that of experts (AUC over 0.95, suggesting that it is feasible to automatically detect the presence of nanotechnology products in CT summaries with a high degree of accuracy. This can significantly speed up the process of finding whether reports on ClinicalTrials.gov might be relevant to a particular nanoparticle or nanodevice

A machine learning approach to identify clinical trials involving nanodrugs and nanodevices from ClinicalTrials.gov.

Science.gov (United States)

de la Iglesia, Diana; García-Remesal, Miguel; Anguita, Alberto; Muñoz-Mármol, Miguel; Kulikowski, Casimir; Maojo, Víctor

2014-01-01

Clinical Trials (CTs) are essential for bridging the gap between experimental research on new drugs and their clinical application. Just like CTs for traditional drugs and biologics have helped accelerate the translation of biomedical findings into medical practice, CTs for nanodrugs and nanodevices could advance novel nanomaterials as agents for diagnosis and therapy. Although there is publicly available information about nanomedicine-related CTs, the online archiving of this information is carried out without adhering to criteria that discriminate between studies involving nanomaterials or nanotechnology-based processes (nano), and CTs that do not involve nanotechnology (non-nano). Finding out whether nanodrugs and nanodevices were involved in a study from CT summaries alone is a challenging task. At the time of writing, CTs archived in the well-known online registry ClinicalTrials.gov are not easily told apart as to whether they are nano or non-nano CTs-even when performed by domain experts, due to the lack of both a common definition for nanotechnology and of standards for reporting nanomedical experiments and results. We propose a supervised learning approach for classifying CT summaries from ClinicalTrials.gov according to whether they fall into the nano or the non-nano categories. Our method involves several stages: i) extraction and manual annotation of CTs as nano vs. non-nano, ii) pre-processing and automatic classification, and iii) performance evaluation using several state-of-the-art classifiers under different transformations of the original dataset. The performance of the best automated classifier closely matches that of experts (AUC over 0.95), suggesting that it is feasible to automatically detect the presence of nanotechnology products in CT summaries with a high degree of accuracy. This can significantly speed up the process of finding whether reports on ClinicalTrials.gov might be relevant to a particular nanoparticle or nanodevice, which is

Attachment Competences in Children With ADHD During the Social-Skills Training and Attachment (SOSTRA) Randomized Clinical Trial

DEFF Research Database (Denmark)

Storebø, Ole Jakob; Skoog, Maria Annette Annelie; Darling Rasmussen, Pernille

2014-01-01

% confidence interval = [0.31, 3.58], p = .91). In total, 17 children (36%) changed their entry status, 1 (2%) from secure to insecure attachment, while 16 (34%) changed from insecure to secure attachment. Conclusion: The experimental treatment does not seem to affect attachment competences compared......Objective: To investigate the effects of social-skills training and a parental training program on children with ADHD as measured by the children's attachment competences. Method: The SOSTRA trial is a randomized, parallel-group, outcome-assessor-blinded, superiority trial evaluating 8 weeks social......-skills training and parental training plus standard treatment versus standard treatment alone for 8- to 12-year old children with ADHD. Results: There were no significant differences in attachment competences at 6 months between the experimental (n = 25) and the control (n = 22) groups (odds ratio = 1.06, 95...

Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study.

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Andrew Schumacher

Full Text Available Informed consent forms (ICFs for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies.We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics.Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials were significantly longer (P < .0001 and had lower Flesch ease-of-reading scores (P = .003 than investigator-initiated trials (N = 11. At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011. The scores did not differ significantly by type of cancer therapy (P = .12 or trial sponsor (P = .38.Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient's education level or cultural characteristics should be evaluated across socio-demographic groups.Clinicaltrials.gov NCT01772511.

Monochromatic minibeam radiotherapy: theoretical and experimental dosimetry for preclinical treatment plans

Energy Technology Data Exchange (ETDEWEB)

Deman, P; Vautrin, M; Stupar, V; Barbier, E L; Elleaume, H; Esteve, F; Adam, J F, E-mail: adam@esrf.fr [INSERM, U836, BP 170, Grenoble Cedex 9, F-38042 (France)

2011-07-21

Monochromatic x-ray minibeam radiotherapy is a new radiosurgery approach based on arrays of submillimetric interlaced planar x-ray beams. The aim of this study was to characterize the dose distributions obtained with this new modality when being used for preclinical trials. Monte Carlo simulations were performed in water phantoms. Percentage depth-dose curves and dose profiles were computed for single incidences and interleaved incidences of 80 keV planar x-ray minibeam (0.6 x 5 mm) arrays. Peak to valley dose ratios were also computed at various depths for an increasing number of minibeams. 3D experimental polymer gel (nPAG) dosimetry measurements were performed using MRI devices designed for small animal imaging. These very high spatial resolution (50 {mu}m) dose maps were compared to the simulations. Preclinical minibeams dose distributions were fully characterized. Experimental dosimetry correlated well with Monte Carlo calculations (Student t-tests: p > 0.1). F98 tumor-bearing rats were also irradiated with interleaved minibeams (80 keV, prescribed dose: 25 Gy). This associated preclinical trial serves as a proof of principle of the technique. The mean survival time of irradiated glioma-bearing rats increased significantly, when compared to the untreated animals (59.6 {+-} 2.8 days versus 28.25 {+-} 0.75 days, p < 0.001).

Understanding Clinical Trials

Science.gov (United States)

Watch these videos to learn about some basic aspects of cancer clinical trials such as the different phases of clinical trials, methods used to protect patient safety, and how the costs of clinical trials are covered.

Experimental Investigations of Noise Control in Planetary Gear Set by Phasing

Directory of Open Access Journals (Sweden)

S. H. Gawande

2014-01-01

Full Text Available Now a days reduction of gear noise and resulting vibrations has received much attention of the researchers. The internal excitation caused by the variation in tooth mesh stiffness is a key factor in causing vibration. Therefore to reduce gear noise and vibrations several techniques have been proposed in recent years. In this research the experimental work is carried out to study the effect of planet phasing on noise and subsequent resulting vibrations of Nylon-6 planetary gear drive. For this purpose experimental set-up was built and trials were conducted for two different arrangements (i.e., with phasing and without phasing and it is observed that the noise level and resulting vibrations were reduced by planet phasing arrangement. So from the experimental results it is observed that by applying the meshing phase difference one can reduce planetary gear set noise and vibrations.

Mass and heat transfer on B7 structured packing in the separation of hydrogen isotopes by distillation

International Nuclear Information System (INIS)

Croitoru, C.; Pop, F.; Titescu, Gh.; Culcer, M.; Iliescu, M.; Stefanescu, I.; Trancota, D.; Peculea, M.

2002-01-01

The paper presents theoretical and experimental data concerning mass and heat transfer on B7 ordered packing, at deuterium separation by distillation. The first section of the paper is dedicated to the mass transfer study of hydrogen distillation, while the second section deals with mass and heat transfer in water distillation. A mathematical model was worked out and compared with experimental data, obtained from two laboratory distillation plants for deuterium separation. From the first plant experimental data concerning B7 ordered packing efficiency of hydrogen cryogenic distillation at 250 deg. C level were obtained. Data concerning mass and heat transfer on the same packing in deuterium separation by water vacuum distillation at 60 deg. C level were obtained in the second plant. HUT values, mass and heat transfer coefficients both theoretically evaluated and experimentally determined were found to be comparable with those obtained from chemical industry separation processes. The fact justifies the use of multi-tubular column model for description of transfer processes in distillation columns equipped with B7 structured packing. (authors)

Massage therapy decreases pain and perceived fatigue after long-distance Ironman triathlon: a randomised trial

Directory of Open Access Journals (Sweden)

Guilherme S Nunes

2016-04-01

Full Text Available Question: Can massage therapy reduce pain and perceived fatigue in the quadriceps of athletes after a long-distance triathlon race (Ironman? Design: Randomised, controlled trial with concealed allocation, intention-to-treat analysis and blinded outcome assessors. Participants: Seventy-four triathlon athletes who completed an entire Ironman triathlon race and whose main complaint was pain in the anterior portion of the thigh. Intervention: The experimental group received massage to the quadriceps, which was aimed at recovery after competition, and the control group rested in sitting. Outcome measures: The outcomes were pain and perceived fatigue, which were reported using a visual analogue scale, and pressure pain threshold at three points over the quadriceps muscle, which was assessed using digital pressure algometry. Results: The experimental group had significantly lower scores than the control group on the visual analogue scale for pain (MD –7 mm, 95% CI –13 to –1 and for perceived fatigue (MD –15 mm, 95% CI –21 to –9. There were no significant between-group differences for the pressure pain threshold at any of the assessment points. Conclusion: Massage therapy was more effective than no intervention on the post-race recovery from pain and perceived fatigue in long-distance triathlon athletes. Trial registration: Brazilian Registry of Clinical Trials, RBR-4n2sxr. [Nunes GS, Bender PU, de Menezes FS, Yamashitafuji I, Vargas VZ, Wageck B (2016 Massage therapy decreases pain and perceived fatigue after long-distance Ironman triathlon: a randomised trial. Journal of Physiotherapy 62: 83–87

New phase II trial of avelumab, a PD-L1 inhibitor, in recurrent respiratory papillomatosis | Center for Cancer Research

Science.gov (United States)

Dr. Christian Hinrichs, Investigator and Lasker Clinical Research Scholar in the Experimental Transplantation and Immunology Branch (ETIB), is leading a trial of avelumab in patients with recurrent respiratory papillomatosis (RRP). Learn more...

Latency correction of event-related potentials between different experimental protocols

Science.gov (United States)

Iturrate, I.; Chavarriaga, R.; Montesano, L.; Minguez, J.; Millán, JdR

2014-06-01

Objective. A fundamental issue in EEG event-related potentials (ERPs) studies is the amount of data required to have an accurate ERP model. This also impacts the time required to train a classifier for a brain-computer interface (BCI). This issue is mainly due to the poor signal-to-noise ratio and the large fluctuations of the EEG caused by several sources of variability. One of these sources is directly related to the experimental protocol or application designed, and may affect the amplitude or latency of ERPs. This usually prevents BCI classifiers from generalizing among different experimental protocols. In this paper, we analyze the effect of the amplitude and the latency variations among different experimental protocols based on the same type of ERP. Approach. We present a method to analyze and compensate for the latency variations in BCI applications. The algorithm has been tested on two widely used ERPs (P300 and observation error potentials), in three experimental protocols in each case. We report the ERP analysis and single-trial classification. Main results. The results obtained show that the designed experimental protocols significantly affect the latency of the recorded potentials but not the amplitudes. Significance. These results show how the use of latency-corrected data can be used to generalize the BCIs, reducing the calibration time when facing a new experimental protocol.

Types of Cancer Clinical Trials

Science.gov (United States)

Information about the several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, supportive and palliative care trials. Each type of trial is designed to answer different research questions.

Evaluation of fast experimental reactor claddings, (2)

International Nuclear Information System (INIS)

Miura, Makoto; Nagaki, Hiroshi; Koyama, Masahiro; Tanaka, Yasumasa

1974-01-01

Thin-walled fine tubes of Type 316 austenitic stainless steel are used for fuel cladding in Joyo (experimental FBR). The material exhibits the change of the mechanical properties in long-time annealing at high temperature, resulting from the precipitation of carbide in structure. In this connection, the experiment and the results on the changes of the microstructure and mechanical properties (proof stress and hardness) are described. The test specimens are the fuel cladding tubes produced for trial for Joyo core and those for FFTF core made in the U.S.A. They were heated between 400 0 and 850 0 C for 1000 hr in vacuum. (Mori, K.)

Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial

Science.gov (United States)

2014-01-01

Background Over the years, there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture. It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5 years without implant failures, when delayed loading was used. However, other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied. Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading. Methods/design This prospective nine-center randomized controlled clinical trial is still ongoing. The final patient will complete the trial in 2016. In total, 180 edentulous patients between 60 and 89 years with sufficient complete dentures will receive one median implant in the edentulous mandible, which will retain the existing complete denture using a ball attachment. Loading of the median implant is either immediately after implant placement (experimental group) or delayed by 3 months of submerged healing at second-stage surgery (control group). Follow-up of patients will be performed for 24 months after implant loading. The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group. The secondary outcome measures encompass clinical, technical and subjective variables. The study was funded by the Deutsche Forschungsgemeinschaft (German research foundation, KE 477/8-1). Discussion This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded. If viable, this treatment option will strongly improve everyday dental practice. Trial registration The trial

Conducting clinical trials in Singapore.

Science.gov (United States)

Woo, K T

1999-04-01

All clinical trials in Singapore will now have to conform to the Medicines (Clinical Trials) Amended Regulations 1998 and the Singapore Good Clinical Practice (GCP) Guidelines 1998. The Medical Clinical Research Committee (MCRC) has been established to oversee the conduct of clinical drug trials in Singapore and together with the legislations in place, these will ensure that clinical trials conducted in Singapore are properly controlled and the well-being of trial subjects are safe guarded. All clinical drug trials require a Clinical Trial Certificate from the MCRC before the trial can proceed. The hospital ethics committee (EC) vets the application for a trial certificate before it is sent to MCRC. The drug company sponsoring the trial has to indemnify the trial investigators and the hospital for negligence arising from the trial. The MCRC, apart from ensuring the safety of trial subjects, has to provide continuing review of the clinical trial and monitors adverse events in the course of the trial. The EC will conduct continuing review of clinical trials. When a non-drug clinical trial is carried out, the EC will ensure that the proposed protocol addresses ethical concerns and meets regulatory requirements for such trials. There is great potential for pharmaceutical Research & Development (R&D) in Singapore. We must develop our skills and infrastructure in clinical trials to enable Singapore to be a regional hub for R&D of drugs in Asia.

Affective-Cognitive Behavioral Therapy for Fibromyalgia: A Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Robert L. Woolfolk

2012-01-01

Full Text Available A randomized controlled trial was conducted to assess the efficacy of an individually administered form of cognitive behavioral treatment for fibromyalgia. In an additive design, 76 patients diagnosed with fibromyalgia were randomly assigned to either the experimental treatment (affective-cognitive behavioral therapy, 10 individual sessions, one per week administered concurrently with treatment-as-usual or to an unaugmented treatment-as-usual condition. Statistical analysis conducted at the end of treatment (3 months after the baseline assessment and at a followup (9 months after the baseline assessment indicated that the patients receiving the experimental treatment reported less pain and overall better functioning than control patients, both at posttreatment and at followup. The implications of these findings for future research are discussed.

Trial-to-Trial Fluctuations in Attentional State and Their Relation to Intelligence

Science.gov (United States)

Unsworth, Nash; McMillan, Brittany D.

2014-01-01

Trial-to-trial fluctuations in attentional state while performing measures of intelligence were examined in the current study. Participants performed various measures of fluid and crystallized intelligence while also providing attentional state ratings prior to each trial. It was found that pre-trial attentional state ratings strongly predicted…

Estimating economic thresholds for site-specific weed control using manual weed counts and sensor technology: an example based on three winter wheat trials.

Science.gov (United States)

Keller, Martina; Gutjahr, Christoph; Möhring, Jens; Weis, Martin; Sökefeld, Markus; Gerhards, Roland

2014-02-01

Precision experimental design uses the natural heterogeneity of agricultural fields and combines sensor technology with linear mixed models to estimate the effect of weeds, soil properties and herbicide on yield. These estimates can be used to derive economic thresholds. Three field trials are presented using the precision experimental design in winter wheat. Weed densities were determined by manual sampling and bi-spectral cameras, yield and soil properties were mapped. Galium aparine, other broad-leaved weeds and Alopecurus myosuroides reduced yield by 17.5, 1.2 and 12.4 kg ha(-1) plant(-1)  m(2) in one trial. The determined thresholds for site-specific weed control with independently applied herbicides were 4, 48 and 12 plants m(-2), respectively. Spring drought reduced yield effects of weeds considerably in one trial, since water became yield limiting. A negative herbicide effect on the crop was negligible, except in one trial, in which the herbicide mixture tended to reduce yield by 0.6 t ha(-1). Bi-spectral cameras for weed counting were of limited use and still need improvement. Nevertheless, large weed patches were correctly identified. The current paper presents a new approach to conducting field trials and deriving decision rules for weed control in farmers' fields. © 2013 Society of Chemical Industry.

Microscopic model for the non-linear fluctuating hydrodynamic of {sup 4} He superfluid helium deduced by maximum entropy method; Modelo microscopico para la hidrodinamica fluctuante no lineal del {sup 4}He superfluido deducido mediante el metodo de maxima entropia

Energy Technology Data Exchange (ETDEWEB)

Alvarez R, J.T

1998-10-01

This thesis presents a microscopic model for the non-linear fluctuating hydrodynamic of superfluid helium ({sup 4} He), model developed by means of the Maximum Entropy Method (Maxent). In the chapter 1, it is demonstrated the necessity to developing a microscopic model for the fluctuating hydrodynamic of the superfluid helium, starting from to show a brief overview of the theories and experiments developed in order to explain the behavior of the superfluid helium. On the other hand, it is presented the Morozov heuristic method for the construction of the non-linear hydrodynamic fluctuating of simple fluid. Method that will be generalized for the construction of the non-linear fluctuating hydrodynamic of the superfluid helium. Besides, it is presented a brief summary of the content of the thesis. In the chapter 2, it is reproduced the construction of a Generalized Fokker-Planck equation, (GFP), for a distribution function associated with the coarse grained variables. Function defined with aid of a nonequilibrium statistical operator {rho}hut{sub FP} that is evaluated as Wigneris function through {rho}{sub CG} obtained by Maxent. Later this equation of GFP is reduced to a non-linear local FP equation from considering a slow and Markov process in the coarse grained variables. In this equation appears a matrix D{sub mn} defined with a nonequilibrium coarse grained statistical operator {rho}hut{sub CG}, matrix elements are used in the construction of the non-linear fluctuating hydrodynamics equations of the superfluid helium. In the chapter 3, the Lagrange multipliers are evaluated for to determine {rho}hut{sub CG} by means of the local equilibrium statistical operator {rho}hut{sub l}-tilde with the hypothesis that the system presents small fluctuations. Also are determined the currents associated with the coarse grained variables and furthermore are evaluated the matrix elements D{sub mn} but with aid of a quasi equilibrium statistical operator {rho}hut{sub qe} instead

Impact of Video Self-Monitoring with Graduated Training on Implementation of Embedded Instructional Learning Trials

Science.gov (United States)

Bishop, Crystal D.; Snyder, Patricia A.; Crow, Robert E.

2015-01-01

We used a multi-component single-subject experimental design across three preschool teachers to examine the effects of video self-monitoring with graduated training and feedback on the accuracy with which teachers monitored their implementation of embedded instructional learning trials. We also examined changes in teachers' implementation of…

Design of clinical trials involving multiple hypothesis tests with a common control.

Science.gov (United States)

Schou, I Manjula; Marschner, Ian C

2017-07-01

Randomized clinical trials comparing several treatments to a common control are often reported in the medical literature. For example, multiple experimental treatments may be compared with placebo, or in combination therapy trials, a combination therapy may be compared with each of its constituent monotherapies. Such trials are typically designed using a balanced approach in which equal numbers of individuals are randomized to each arm, however, this can result in an inefficient use of resources. We provide a unified framework and new theoretical results for optimal design of such single-control multiple-comparator studies. We consider variance optimal designs based on D-, A-, and E-optimality criteria, using a general model that allows for heteroscedasticity and a range of effect measures that include both continuous and binary outcomes. We demonstrate the sensitivity of these designs to the type of optimality criterion by showing that the optimal allocation ratios are systematically ordered according to the optimality criterion. Given this sensitivity to the optimality criterion, we argue that power optimality is a more suitable approach when designing clinical trials where testing is the objective. Weighted variance optimal designs are also discussed, which, like power optimal designs, allow the treatment difference to play a major role in determining allocation ratios. We illustrate our methods using two real clinical trial examples taken from the medical literature. Some recommendations on the use of optimal designs in single-control multiple-comparator trials are also provided. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Clinical Trials

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Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...

Modelflow Estimates of Stroke Volume Do Not Correlate With Doppler Ultrasound Estimates During Upright Posture

Science.gov (United States)

Ferguson, Connor R.; Lee, Stuart M. C.; Stenger, Michael B.; Platts, Steven H.; Laurie, Steven S.

2014-01-01

Orthostatic intolerance affects 60-80% of astronauts returning from long-duration missions, representing a significant risk to completing mission-critical tasks. While likely multifactorial, a reduction in stroke volume (SV) represents one factor contributing to orthostatic intolerance during stand and head up tilt (HUT) tests. Current measures of SV during stand or HUT tests use Doppler ultrasound and require a trained operator and specialized equipment, restricting its use in the field. BeatScope (Finapres Medical Systems BV, The Netherlands) uses a modelflow algorithm to estimate SV from continuous blood pressure waveforms in supine subjects; however, evidence supporting the use of Modelflow to estimate SV in subjects completing stand or HUT tests remain scarce. Furthermore, because the blood pressure device is held extended at heart level during HUT tests, but allowed to rest at the side during stand tests, changes in the finger arterial pressure waveform resulting from arm positioning could alter modelflow estimated SV. The purpose of this project was to compare Doppler ultrasound and BeatScope estimations of SV to determine if BeatScope can be used during stand or HUT tests. Finger photoplethysmography was used to acquire arterial pressure waveforms corrected for hydrostatic finger-to-heart height using the Finometer (FM) and Portapres (PP) arterial pressure devices in 10 subjects (5 men and 5 women) during a stand test while simultaneous estimates of SV were collected using Doppler ultrasound. Measures were made after 5 minutes of supine rest and while subjects stood for 5 minutes. Next, SV estimates were reacquired while each arm was independently raised to heart level, a position similar to tilt testing. Supine SV estimates were not significantly different between all three devices (FM: 68+/-20, PP: 71+/-21, US: 73+/-21 ml/beat). Upon standing, the change in SV estimated by FM (-18+/-8 ml) was not different from PP (-21+/-12), but both were significantly

Linking ClinicalTrials.gov and PubMed to track results of interventional human clinical trials.

Directory of Open Access Journals (Sweden)

Vojtech Huser

Full Text Available OBJECTIVE: In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world's largest clinical trial registry. MATERIALS AND METHODS: We considered two trial result artifacts: (1 existence of a trial result journal article that is formally linked to a registered trial or (2 the deposition of a trial's basic summary results within the registry. RESULTS: The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2% had no structured trial-article link present. A total of 2367 trials (26.6% deposited basic summary results within the registry. Of those, 969 trials (10.9% were classified as trials with extended results and 1398 trials (15.7% were classified as trials with only required basic results. The majority of the trials (54.8% had no evidence of results, based on either linked result articles or basic summary results (silent trials, while a minimal number (9.2% report results through both registry deposition and publication. DISCUSSION: Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the "trialome". Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased. CONCLUSION: Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.

Variability, plot size and border effect in lettuce trials in protected environment

Directory of Open Access Journals (Sweden)

Daniel Santos

2018-03-01

Full Text Available ABSTRACT The variability within rows of cultivation may reduce the accuracy of experiments conducted in a complete randomized block design if the rows are considered as blocks, however, little is known about this variability in protected environments. Thus, our aim was to study the variability of the fresh mass in lettuce shoot, growing in protected environment, and to verify the border effect and size of the experimental unit in minimizing the productive variability. Data from two uniformity trials carried out in a greenhouse in autumn and spring growing seasons were used. In the statistical analyses, it was considered the existence of parallel cultivation rows the lateral openings of the greenhouse and of columns perpendicular to these openings. Different scenarios were simulated by excluding rows and columns to generate several borders arrangements and also to use different sizes of the experimental unit. For each scenario, homogeneity test of variances between remaining rows and columns was performed, and it was calculated the variance and coefficient of variation. There is variability among rows in trials with lettuce in plastic greenhouses and the border use does not bring benefits in terms of reduction of the coefficient of variation or minimizing the cases of heterogeneous variances among rows. In experiments with lettuce in a plastic greenhouse, the use of an experimental unit size greater than or equal to two plants provides homogeneity of variances among rows and columns and, therefore, allows the use of a completely randomized design.

Distribution-independent hierarchicald N-body methods

International Nuclear Information System (INIS)

Aluru, S.

1994-01-01

The N-body problem is to simulate the motion of N particles under the influence of mutual force fields based on an inverse square law. The problem has applications in several domains including astrophysics, molecular dynamics, fluid dynamics, radiosity methods in computer graphics and numerical complex analysis. Research efforts have focused on reducing the O(N 2 ) time per iteration required by the naive algorithm of computing each pairwise interaction. Widely respected among these are the Barnes-Hut and Greengard methods. Greengard claims his algorithm reduces the complexity to O(N) time per iteration. Throughout this thesis, we concentrate on rigorous, distribution-independent, worst-case analysis of the N-body methods. We show that Greengard's algorithm is not O(N), as claimed. Both Barnes-Hut and Greengard's methods depend on the same data structure, which we show is distribution-dependent. For the distribution that results in the smallest running time, we show that Greengard's algorithm is Ω(N log 2 N) in two dimensions and Ω(N log 4 N) in three dimensions. We have designed a hierarchical data structure whose size depends entirely upon the number of particles and is independent of the distribution of the particles. We show that both Greengard's and Barnes-Hut algorithms can be used in conjunction with this data structure to reduce their complexity. Apart from reducing the complexity of the Barnes-Hut algorithm, the data structure also permits more accurate error estimation. We present two- and three-dimensional algorithms for creating the data structure. The multipole method designed using this data structure has a complexity of O(N log N) in two dimensions and O(N log 2 N) in three dimensions

The impact of preload reduction with head-up tilt testing on longitudinal and transverse left ventricular mechanics.

Science.gov (United States)

Schneider, Caroline; Forsythe, Lynsey; Somauroo, John; George, Keith; Oxborough, David

2018-01-03

Left ventricular (LV) function is dependent on load, intrinsic contractility and relaxation with a variable impact on specific mechanics. Strain (ε) imaging allows the assessment of cardiac function however the direct relationship between volume and strain is currently unknown. The aim of this study was to establish the impact of preload reduction through head-up tilt (HUT) testing on simultaneous left ventricular (LV) longitudinal and transverse function and their respective contribution to volume change. A focused transthoracic echocardiogram was performed on 10 healthy male participants (23 ± 3 years,) in the supine position and following 1 min and 5 min of HUT testing. Raw temporal longitudinal ε (Ls) and transverse ε (Ts) values were exported and divided into 5% increments across the cardiac cycle and corresponding LV volumes were traced at each 5% increment. This provided simultaneous LV longitudinal and transverse ε and volume-loops (deformation-volume analysis - DVA). There was a leftward- shift of the ε -volume loop from supine to 1 min and 5 min of HUT, ptransverse thickening from supine to 1min, which was further augmented at 5min (p=0.018). Preload reduction occurs within 1 minute of HUT but does not further reduce at 5 minutes. This decline is associated with a decrease in longitudinal ε and concomitant increase in transverse ε. Consequently, augmented transverse relaxation appears to be an important factor in the maintenance of LV filling in the setting of reduced preload. DVA provides information on the relative contribution of mechanics to a change in LV volume and may have a role in the assessment of clinical populations. © 2018 The authors.

Clinical Impact Research - how to choose experimental or observational intervention study?

Science.gov (United States)

Malmivaara, Antti

2016-11-01

Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. The new concept is based on a narrative review of the literature and on author's idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author's previous work on the concepts benchmarking controlled trial and system impact research (SIR). The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messages The new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals. The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study designs: randomized controlled trials (RCTs) (experimental

Brightness temperature simulation of snow cover based on snow grain size evolution using in situ data

Science.gov (United States)

Wu, Lili; Li, Xiaofeng; Zhao, Kai; Zheng, Xingming; Jiang, Tao

2016-07-01

Snow depth parameter inversion from passive microwave remote sensing is of great significance to hydrological process and climate systems. The Helsinki University of Technology (HUT) model is a commonly used snow emission model. Snow grain size (SGS) is one of the important input parameters, but SGS is difficult to obtain in broad areas. The time series of SGS are first evolved by an SGS evolution model (Jordan 91) using in situ data. A good linear relationship between the effective SGS in HUT and the evolution SGS was found. Then brightness temperature simulations are performed based on the effective SGS and evolution SGS. The results showed that the biases of the simulated brightness temperatures based on the effective SGS and evolution SGS were -6.5 and -3.6 K, respectively, for 18.7 GHz and -4.2 and -4.0 K for 36.5 GHz. Furthermore, the model is performed in six pixels with different land use/cover type in other areas. The results showed that the simulated brightness temperatures based on the evolution SGS were consistent with those from the satellite. Consequently, evolution SGS appears to be a simple method to obtain an appropriate SGS for the HUT model.

Survey of cabbage experimental hybrids (Brassica oleracea var. capitata L.

Directory of Open Access Journals (Sweden)

Červenski Janko

2006-01-01

Full Text Available Cabbage takes up significant area in vegetable sowing structure, and one of the factors of improving this production is adequate varieties selection. During the breeding process, experimental hybrids are tested in relation to currently grown varieties and hybrids in production. In this paper the characteristics of 18 cabbage genotypes are presented, out of which there are 9 experimental hybrids, 4 varieties and 5 hybrids from broader production. Cabbage genotypes in the trial are of differing length of growing season, as well as differing head weight. Properties variability analysis was performed using PCA method, where two main components were chosen based on screen test, and these were used to define 57.7%. Head weight and head diameter are properties based on which the tested hybrids were graded into quantitatively different groups.

Clinical Trials

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Full Text Available ... to main content U.S. Department of Health & Human ... of people. Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ...

Clinical Trials

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Full Text Available ... risks that outweigh any possible benefits. Clinical Trial Phases Clinical trials of new medicines or medical devices are done in phases. These phases have different purposes and help researchers ...

A phase I/II trial of AT9283, a selective inhibitor of aurora kinase in children with relapsed or refractory acute leukemia: challenges to run early phase clinical trials for children with leukemia.

Science.gov (United States)

Vormoor, B; Veal, G J; Griffin, M J; Boddy, A V; Irving, J; Minto, L; Case, M; Banerji, U; Swales, K E; Tall, J R; Moore, A S; Toguchi, M; Acton, G; Dyer, K; Schwab, C; Harrison, C J; Grainger, J D; Lancaster, D; Kearns, P; Hargrave, D; Vormoor, J

2017-06-01

Aurora kinases regulate mitosis and are commonly overexpressed in leukemia. This phase I/IIa study of AT9283, a multikinase inhibitor, was designed to identify maximal tolerated doses, safety, pharmacokinetics, and pharmacodynamic activity in children with relapsed/refractory acute leukemia. The trial suffered from poor recruitment and terminated early, therefore failing to identify its primary endpoints. AT9283 caused tolerable toxicity, but failed to show clinical responses. Future trials should be based on robust preclinical data that provide an indication of which patients may benefit from the experimental agent, and recruitment should be improved through international collaborations and early combination with established treatment strategies. © 2016 Wiley Periodicals, Inc.

A trial of direct control of pine engraver beetles on a small logging unit

Science.gov (United States)

W. L. Jackson

1960-01-01

Laboratory tests and small-scale field trials have shown the insecticide lindane to be highly toxic to pine engraver beetles. On the basis of that information, the insecticide was applied to fresh logging slash heavily infested with pine engraver beetles at Challenge Experimental Forest in 1959. Costs were reasonable and no insurmountable problems were encountered....

Clinical Trials

Medline Plus

Full Text Available ... well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

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

Directory of Open Access Journals (Sweden)

Emili Balaguer-Ballester

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

Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

Science.gov (United States)

Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

2017-12-01

Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (ppublication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

Preclinical experimental models of drug metabolism and disposition in drug discovery and development

Directory of Open Access Journals (Sweden)

Donglu Zhang

2012-12-01

Full Text Available Drug discovery and development involve the utilization of in vitro and in vivo experimental models. Different models, ranging from test tube experiments to cell cultures, animals, healthy human subjects, and even small numbers of patients that are involved in clinical trials, are used at different stages of drug discovery and development for determination of efficacy and safety. The proper selection and applications of correct models, as well as appropriate data interpretation, are critically important in decision making and successful advancement of drug candidates. In this review, we discuss strategies in the applications of both in vitro and in vivo experimental models of drug metabolism and disposition.

Relations between zero-inflated variables in trials with horticultural crops

Directory of Open Access Journals (Sweden)

Alessandro D. Lúcio

2016-06-01

Full Text Available Certain characteristics of some vegetable crops allow multiple harvests during the production cycle; however, to our knowledge, no study has described the behavior of fruit production with progression of the production cycle in vegetable crops with multiple harvests that present data overdispersion. We aimed to characterize the data overdispersion of zero-inflated variables and identify the behavior of these variables during the production cycle of several vegetable crops with multiple harvests. Data from 11 uniformity trials were used without applying treatments; these comprise the database from the Experimental Plants Group at the Federal University of Santa Maria, Brazil. The trials were conducted using four horticultural species grown during different cultivation seasons, cultivation environments, and experimental structures. Although at each harvest, a larger number of basic units with harvest fruit was observed than units without harvest fruit, the basic unit percentage without fruit was high, generating an overdispersion within each individual harvest. The variability within each harvest was high and increased with the evolution of the production cycle of Capsicum annuum, Solanum lycopersicum var. cerasiforme, Phaseolus vulgaris, and Cucurbita pepo species. However, the correlation coefficient between the mean weight and number of harvest fruits tended to remain constant during the crop production cycle. These behaviors show that harvest management should be done individually, at each harvest, such that data overdispersion is reduced.

Relations between zero-inflated variables in trials with horticultural crops

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Lúcio, A.D.; Nunes, L.F.; Rego, F.; Pasini, M.P.B.

2016-11-01

Certain characteristics of some vegetable crops allow multiple harvests during the production cycle; however, to our knowledge, no study has described the behavior of fruit production with progression of the production cycle in vegetable crops with multiple harvests that present data overdispersion. We aimed to characterize the data overdispersion of zero-inflated variables and identify the behavior of these variables during the production cycle of several vegetable crops with multiple harvests. Data from 11 uniformity trials were used without applying treatments; these comprise the database from the Experimental Plants Group at the Federal University of Santa Maria, Brazil. The trials were conducted using four horticultural species grown during different cultivation seasons, cultivation environments, and experimental structures. Although at each harvest, a larger number of basic units with harvest fruit was observed than units without harvest fruit, the basic unit percentage without fruit was high, generating an overdispersion within each individual harvest. The variability within each harvest was high and increased with the evolution of the production cycle of Capsicum annuum, Solanum lycopersicum var. cerasiforme, Phaseolus vulgaris, and Cucurbita pepo species. However, the correlation coefficient between the mean weight and number of harvest fruits tended to remain constant during the crop production cycle. These behaviors show that harvest management should be done individually, at each harvest, such that data overdispersion is reduced. (Author)

Sensitivity of adaptive enrichment trial designs to accrual rates, time to outcome measurement, and prognostic variables

Directory of Open Access Journals (Sweden)

Tianchen Qian

2017-12-01

Full Text Available Adaptive enrichment designs involve rules for restricting enrollment to a subset of the population during the course of an ongoing trial. This can be used to target those who benefit from the experimental treatment. Trial characteristics such as the accrual rate and the prognostic value of baseline variables are typically unknown when a trial is being planned; these values are typically assumed based on information available before the trial starts. Because of the added complexity in adaptive enrichment designs compared to standard designs, it may be of special concern how sensitive the trial performance is to deviations from assumptions. Through simulation studies, we evaluate the sensitivity of Type I error, power, expected sample size, and trial duration to different design characteristics. Our simulation distributions mimic features of data from the Alzheimer's Disease Neuroimaging Initiative cohort study, and involve two subpopulations based on a genetic marker. We investigate the impact of the following design characteristics: the accrual rate, the time from enrollment to measurement of a short-term outcome and the primary outcome, and the prognostic value of baseline variables and short-term outcomes. To leverage prognostic information in baseline variables and short-term outcomes, we use a semiparametric, locally efficient estimator, and investigate its strengths and limitations compared to standard estimators. We apply information-based monitoring, and evaluate how accurately information can be estimated in an ongoing trial.

Methods for experimental design principles and applications for physicists and chemists

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Goupy, J

1993-01-01

A method for organizing and conducting scientific experiments is described in this volume which enables experimenters to reduce the number of trials run, while retaining all the parameters that may influence the result. The choice of ideal experiments is based on mathematical concepts, but the author adopts a practical approach and uses theory only when necessary. Written for experimenters by an experimenter, it is an introduction to the philosophy of scientific investigation. Researchers with limited time and resources at their disposal will find this text a valuable guide for solving specific problems efficiently. The presentation makes extensive use of examples, and the approach and methods are graphical rather than numerical. All calculations can be performed on a personal computer; readers are assumed to have no previous knowledge of the subject. The presentation is such that the beginner may acquire a thorough understanding of the basic concepts. However, there is also sufficient material to challenge t...

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Genotype by environment interaction in sunflower (Helianthus annus L.) to optimize trial network efficiency

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Gonzalez-Barrios, P.; Castro, M.; Pérez, O.; Vilaró, D.; Gutiérrez, L.

2017-07-01

Modeling genotype by environment interaction (GEI) is one of the most challenging aspects of plant breeding programs. The use of efficient trial networks is an effective way to evaluate GEI to define selection strategies. Furthermore, the experimental design and the number of locations, replications, and years are crucial aspects of multi-environment trial (MET) network optimization. The objective of this study was to evaluate the efficiency and performance of a MET network of sunflower (Helianthus annuus L.). Specifically, we evaluated GEI in the network by delineating mega-environments, estimating genotypic stability and identifying relevant environmental covariates. Additionally, we optimized the network by comparing experimental design efficiencies. We used the National Evaluation Network of Sunflower Cultivars of Uruguay (NENSU) in a period of 20 years. MET plot yield and flowering time information was used to evaluate GEI. Additionally, meteorological information was studied for each sunflower physiological stage. An optimal network under these conditions should have three replications, two years of evaluation and at least three locations. The use of incomplete randomized block experimental design showed reasonable performance. Three mega-environments were defined, explained mainly by different management of sowing dates. Late sowings dates had the worst performance in grain yield and oil production, associated with higher temperatures before anthesis and fewer days allocated to grain filling. The optimization of MET networks through the analysis of the experimental design efficiency, the presence of GEI, and appropriate management strategies have a positive impact on the expression of yield potential and selection of superior cultivars.

Eugenia uniflora Dentifrice for Treating Gingivitis in Children: Antibacterial Assay and Randomized Clinical Trial.

Science.gov (United States)

Jovito, Vanessa de Carvalho; Freires, Irlan Almeida; Ferreira, Danilo Augusto de Holanda; Paulo, Marçal de Queiroz; Castro, Ricardo Dias de

2016-01-01

School-age children are frequently at high risk for the onset of biofilm-dependent conditions, including dental caries and periodontal diseases. The objective of this study was to evaluate the clinical efficacy of a dentifrice containing Eugenia uniflora Linn. (Surinam cherry) extract versus a triclosan-based comparator in treating gingivitis in children aged 10-12 years. The in vitro antibacterial potential of the dentifrice was tested against oral pathogens (Streptococcus mutans, Streptococcus oralis and Lactobacillus casei). Then a phase-II clinical trial was conducted with 50 subjects aged 10-12 years, with clinical signs of gingivitis. The subjects were randomly assigned to the experimental group (n=25) and control group (n=25), in which participants used the experimental dentifrice and a triclosan-based fluoridated dentifrice (Colgate Total 12(r)), respectively. Clinical examinations assessed the presence of gingivitis (primary outcome) and biofilm accumulation (secondary outcome) using the Gingival-Bleeding Index (GBI) and Simplified Oral Hygiene Index (OHI-S), respectively, at baseline and after seven days of tooth brushing 3x/day. The data were analyzed using paired and unpaired t-test (GBI) and Wilcoxon and Mann-Whitney (OHI-S), with p≤0.05. The experimental dentifrice showed efficient antibacterial activity in vitro. In the clinical trial, a significant reduction in gingival bleeding was observed in both experimental and control groups (puniflora dentifrice showed anti-gingivitis properties in children aged 10-12 years. Thus, it may be a potentially efficient and safe product to be used alternatively in preventive dental practice.

Integrative Blood Pressure Response to Upright Tilt Post Renal Denervation

Science.gov (United States)

Howden, Erin J.; East, Cara; Lawley, Justin S.; Stickford, Abigail S.L.; Verhees, Myrthe; Fu, Qi

2017-01-01

Abstract BACKGROUND Whether renal denervation (RDN) in patients with resistant hypertension normalizes blood pressure (BP) regulation in response to routine cardiovascular stimuli such as upright posture is unknown. We conducted an integrative study of BP regulation in patients with resistant hypertension who had received RDN to characterize autonomic circulatory control. METHODS Twelve patients (60 ± 9 [SD] years, n = 10 males) who participated in the Symplicity HTN-3 trial were studied and compared to 2 age-matched normotensive (Norm) and hypertensive (unmedicated, HTN) control groups. BP, heart rate (HR), cardiac output (Qc), muscle sympathetic nerve activity (MSNA), and neurohormonal variables were measured supine, and 30° (5 minutes) and 60° (20 minutes) head-up-tilt (HUT). Total peripheral resistance (TPR) was calculated from mean arterial pressure and Qc. RESULTS Despite treatment with RDN and 4.8 (range, 3–7) antihypertensive medications, the RDN had significantly higher supine systolic BP compared to Norm and HTN (149 ± 15 vs. 118 ± 6, 108 ± 8 mm Hg, P < 0.001). When supine, RDN had higher HR, TPR, MSNA, plasma norepinephrine, and effective arterial elastance compared to Norm. Plasma norepinephrine, Qc, and HR were also higher in the RDN vs. HTN. During HUT, BP remained higher in the RDN, due to increases in Qc, plasma norepinephrine, and aldosterone. CONCLUSION We provide evidence of a possible mechanism by which BP remains elevated post RDN, with the observation of increased Qc and arterial stiffness, as well as plasma norepinephrine and aldosterone levels at approximately 2 years post treatment. These findings may be the consequence of incomplete ablation of sympathetic renal nerves or be related to other factors. PMID:28338768

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Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...

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Full Text Available ... Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including ... our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

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Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

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Full Text Available ... treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ... are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and ...

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Full Text Available ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...

Effects of triclosan on host response and microbial biomarkers during experimental gingivitis.

Science.gov (United States)

Pancer, Brooke A; Kott, Diana; Sugai, James V; Panagakos, Fotinos S; Braun, Thomas M; Teles, Ricardo P; Giannobile, William V; Kinney, Janet S

2016-05-01

This exploratory randomized, controlled clinical trial sought to evaluate anti-inflammatory and -microbial effects of triclosan during experimental gingivitis as assessed by host response biomarkers and biofilm microbial pathogens. Thirty participants were randomized to triclosan or control dentifrice groups who ceased homecare for 21 days in an experimental gingivitis (EG) protocol. Plaque and gingival indices and saliva, plaque, and gingival crevicular fluid (GCF) were assessed/collected at days 0, 14, 21 and 35. Levels and proportions of 40 bacterial species from plaque samples were determined using checkerboard DNA-DNA hybridization. Ten biomarkers associated with inflammation, matrix degradation, and host protection were measured from GCF and saliva and analysed using a multiplex array. Participants were stratified as "high" or "low" responders based on gingival index and GCF biomarkers and bacterial biofilm were combined to generate receiver operating characteristic curves and predict gingivitis susceptibility. No differences in mean PI and GI values were observed between groups and non-significant trends of reduction of host response biomarkers with triclosan treatment. Triclosan significantly reduced levels of A. actinomycetemcomitans and P. gingivalis during induction of gingivitis. Triclosan reduced microbial levels during gingivitis development (ClinicalTrials.gov NCT01799226). © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Thinning trials in lowland plantations in the Veneto Region (North-eastern Italy

Directory of Open Access Journals (Sweden)

Mario Pividori

2014-06-01

Full Text Available Thinning trials in lowland plantations in the Veneto Region (North-eastern Italy. More than 234 hectares of new plantations of lowland mixed forest have been realized in the last 20 years in the Veneto Region (North-eastern Italy. In many of these is now needed to start thinning operations, but there is a lack of experience about this topic. Aim of this work was to undertake an experimentation on different types of thinnings. The thinning trial has been performed at Bosco San Marco forest, municipality of Cessalto (Venice, in a very dense hornbeam-oak plantation aged 16. In 2010, three different thinning types were implemented on 9 hectares according to the following layout: geometrical (34% of woody mass removed, selective (15%, mixed geometrical-selective (30%, control plot. Three years later no significant differences between thinning trials in term of diametric growth, geometrical thinning excepted, were observed. These results provide a suite of solutions to the forest manager for choosing the early thinning type in high tree density condition.

Effectiveness of Bioactive Food Components in Experimental Colon Carcinogenesis

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Emília Hijová

2009-01-01

Full Text Available The aim of the present study was the evaluation of possible protective effects of selected bioactive food components in experimental N,N-dimethylhydrazine (DMH-induced colon carcinogenesis. Wistar albino rats (n = 92 were fed a high fat diet or conventional laboratory diet. Two weeks after the beginning of the trial, DMH injections were given to six groups of rats at the dose of 20 mg/kg b.w. twice weekly. The activity of bacterial enzymes in faeces and serum bile acid concentrations were determined. High fat diet, DMH injections, and their combination significantly increased the activies of β-galactosidase, β-glucuronidase, and α-glucosidase (p p < 0.001, as well as the bile acid concentration compared to the group at the highest risk. The protective effects of selected bioactive food components in experimentally induced colon carcinogenesis allow for their possible use in cancer prevention or treatment.

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Full Text Available ... trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ...

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Full Text Available ... Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... and advance medical care. They also can help health care decisionmakers direct resources to the strategies and treatments ...

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Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's ...

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Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

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Full Text Available ... identified earlier than they would be in general medical practice. This is because late-phase trials have large ... supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

Group psychotherapy for eating disorders: A randomized clinical trial and a pre-treatment moderator and mediator analyses

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Davidsen, Annika Helgadóttir

disorders in group therapy. We conducted a randomized clinical trial and included 159 adult participants, 156 females and 3 males, diagnosed with bulimia nervosa, binge eating disorder, or eating disorder not otherwise specified according to DSM-IV. Eighty participants were allocated to the experimental...

Discrete-Trial Functional Analysis and Functional Communication Training with Three Individuals with Autism and Severe Problem Behavior

Science.gov (United States)

Schmidt, Jonathan D.; Drasgow, Erik; Halle, James W.; Martin, Christian A.; Bliss, Sacha A.

2014-01-01

Discrete-trial functional analysis (DTFA) is an experimental method for determining the variables maintaining problem behavior in the context of natural routines. Functional communication training (FCT) is an effective method for replacing problem behavior, once identified, with a functionally equivalent response. We implemented these procedures…

Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial

Directory of Open Access Journals (Sweden)

Doyle Conor

2011-10-01

Full Text Available Abstract Background Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Methods/Design Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. Discussion When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment.

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Full Text Available ... the clinical trial you take part in, the information gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care. Many people volunteer because ...

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Full Text Available ... people who fit the patient traits for that study (the eligibility criteria). Eligibility criteria differ from trial to trial. They include factors such as a patient's age and gender, the type and stage of disease, and whether ...

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Full Text Available ... Sponsors also may stop a trial, or part of a trial, early if the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight ...

Successful recruitment to trials: findings from the SCIMITAR+ Trial.

Science.gov (United States)

Peckham, Emily; Arundel, Catherine; Bailey, Della; Callen, Tracy; Cusack, Christina; Crosland, Suzanne; Foster, Penny; Herlihy, Hannah; Hope, James; Ker, Suzy; McCloud, Tayla; Romain-Hooper, Crystal-Bella; Stribling, Alison; Phiri, Peter; Tait, Ellen; Gilbody, Simon

2018-01-19

Randomised controlled trials (RCT) can struggle to recruit to target on time. This is especially the case with hard to reach populations such as those with severe mental ill health. The SCIMITAR+ trial, a trial of a bespoke smoking cessation intervention for people with severe mental ill health achieved their recruitment ahead of time and target. This article reports strategies that helped us to achieve this with the aim of aiding others recruiting from similar populations. SCIMITAR+ is a multi-centre pragmatic two-arm parallel-group RCT, which aimed to recruit 400 participants with severe mental ill health who smoke and would like to cut down or quit. The study recruited primarily in secondary care through community mental health teams and psychiatrists with a smaller number of participants recruited through primary care. Recruitment opened in October 2015 and closed in December 2016, by which point 526 participants had been recruited. We gathered information from recruiting sites on strategies which led to the successful recruitment in SCIMITAR+ and in this article present our approach to trial management along with the strategies employed by the recruiting sites. Alongside having a dedicated trial manager and trial management team, we identified three main themes that led to successful recruitment. These were: clinicians with a positive attitude to research; researchers and clinicians working together; and the use of NHS targets. The overriding theme was the importance of relationships between both the researchers and the recruiting clinicians and the recruiting clinicians and the participants. This study makes a significant contribution to the limited evidence base of real-world cases of successful recruitment to RCTs and offers practical guidance to those planning and conducting trials. Building positive relationships between clinicians, researchers and participants is crucial to successful recruitment.

Bayesian methods for the design and interpretation of clinical trials in very rare diseases

Science.gov (United States)

Hampson, Lisa V; Whitehead, John; Eleftheriou, Despina; Brogan, Paul

2014-01-01

This paper considers the design and interpretation of clinical trials comparing treatments for conditions so rare that worldwide recruitment efforts are likely to yield total sample sizes of 50 or fewer, even when patients are recruited over several years. For such studies, the sample size needed to meet a conventional frequentist power requirement is clearly infeasible. Rather, the expectation of any such trial has to be limited to the generation of an improved understanding of treatment options. We propose a Bayesian approach for the conduct of rare-disease trials comparing an experimental treatment with a control where patient responses are classified as a success or failure. A systematic elicitation from clinicians of their beliefs concerning treatment efficacy is used to establish Bayesian priors for unknown model parameters. The process of determining the prior is described, including the possibility of formally considering results from related trials. As sample sizes are small, it is possible to compute all possible posterior distributions of the two success rates. A number of allocation ratios between the two treatment groups can be considered with a view to maximising the prior probability that the trial concludes recommending the new treatment when in fact it is non-inferior to control. Consideration of the extent to which opinion can be changed, even by data from the best feasible design, can help to determine whether such a trial is worthwhile. © 2014 The Authors. Statistics in Medicine published by John Wiley & Sons, Ltd. PMID:24957522

Promising Therapeutics with Natural Bioactive Compounds for Improving Learning and Memory — A Review of Randomized Trials

Directory of Open Access Journals (Sweden)

Jin-Yong Choi

2012-09-01

Full Text Available Cognitive disorders can be associated with brain trauma, neurodegenerative disease or as a part of physiological aging. Aging in humans is generally associated with deterioration of cognitive performance and, in particular, learning and memory. Different therapeutic approaches are available to treat cognitive impairment during physiological aging and neurodegenerative or psychiatric disorders. Traditional herbal medicine and numerous plants, either directly as supplements or indirectly in the form of food, improve brain functions including memory and attention. More than a hundred herbal medicinal plants have been traditionally used for learning and memory improvement, but only a few have been tested in randomized clinical trials. Here, we will enumerate those medicinal plants that show positive effects on various cognitive functions in learning and memory clinical trials. Moreover, besides natural products that show promising effects in clinical trials, we briefly discuss medicinal plants that have promising experimental data or initial clinical data and might have potential to reach a clinical trial in the near future.

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.

Science.gov (United States)

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

2012-04-28

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. 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

Forecasting Sensorimotor Adaptability from Baseline Inter-Trial Correlations

Science.gov (United States)

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

2014-01-01

measured in the frequency domain. Therefore, we use the power spectrum (PS), which is the Fourier transform of the ACF, to describe our inter-trial correlations. The decay of the PS yields a straight line on a log-log frequency plot, which we quantify by Beta = - (slope of PS on log-log axes). Hence, Beta is a measure of the strength of inter- trial correlations in the baseline data. Larger Beta values are indicative of longer inter-trial correlations. Experimental Approach: We will begin by performing a retrospective analysis of treadmill-gait adaptation data previously collected by Dr. Bloomberg and colleagues. Specifically, we will quantify the strength of inter-trial correlations in the baseline step cadence and heart rate data and compare it to the locomotor adaptability performance results already described by these investigators. Incorporating these datasets will also allow us to explore the applicability of (and potential limitations surrounding) the use of Beta in forecasting physiological performance. We will also perform a new experiment, in which Beta will be derived from baseline data collected during over-ground (non-treadmill) walking, which will enable us to consider locomotor performance, through the parameter Beta, under the most functionallyrelevant, natural gait condition. This experiment will incorporate two baseline and five post-training over-ground locomotion tests to explore the consistency and potential adaptability of the Beta values themselves. HYPOTHESES: We hypothesize that the strength of baseline inter-trial correlations of step cadence and heart rate will relate to locomotor adaptability. Specifically, we anticipate that individuals who show weaker longer-term inter-trial correlations in baseline step cadence data will be the better adaptors, as step cadence can be modified in real-time (i.e., online corrections are an inherent property of the locomotor system; analogous to results observed in the VOR). Conversely, because heart rate is not

Clinical Trials

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Full Text Available ... other expenses (for example, travel and child care)? Who will be in charge of my care? What will happen after the trial? Taking part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

Does clinical equipoise apply to cluster randomized trials in health research?

Science.gov (United States)

2011-01-01

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial

Uganda gets set for vaccine trials, but the ethical debate continues.

Science.gov (United States)

1997-04-01

An HIV vaccine trial scheduled for 1997 involves 2000 male and female members of the Uganda People's Defence Force. The volunteers are 18-40 years old and have been evaluated for 18 months. The trial of Alvac-HIV vaccine developed by Pasteur Manieux Connaught will be conducted by the Joint Clinical Research Council, a joint venture of Makerere University and the Ministries of Health and Defence, in collaboration with the Johns Hopkins University. The vaccine has already been tested on 300 volunteers in France and the US. The initial stage of testing will involve a randomized, placebo-controlled, double-blind trial comparing the safety and immunogenicity of four successive injections in 20 HIV-negative and 20 HIV-positive volunteers. Follow-up will continue for a year. While volunteers will get free medical attention if they develop a severe reaction to the vaccine and will receive a full explanation about the experimental nature of the vaccine, it has not been determined how volunteers will be compensated if something unforeseen goes wrong. Additional concerns revolve around Uganda's readiness to institute proper legal controls and ethical standards in cases of biomedical research.

Improvement in balance using a virtual reality-based stepping exercise: a randomized controlled trial involving individuals with chronic stroke.

Science.gov (United States)

Lloréns, Roberto; Gil-Gómez, José-Antonio; Alcañiz, Mariano; Colomer, Carolina; Noé, Enrique

2015-03-01

To study the clinical effectiveness and the usability of a virtual reality-based intervention compared with conventional physical therapy in the balance recovery of individuals with chronic stroke. Randomized controlled trial. Outpatient neurorehabilitation unit. A total of 20 individuals with chronic stroke. The intervention consisted of 20 one-hour sessions, five sessions per week. The experimental group combined 30 minutes with the virtual reality-based intervention with 30 minutes of conventional training. The control group underwent one hour conventional therapy. Balance performance was assessed at the beginning and at the end of the trial using the Berg Balance Scale, the balance and gait subscales of the Tinetti Performance-Oriented Mobility Assessment, the Brunel Balance Assessment, and the 10-m Walking Test. Subjective data of the virtual reality-based intervention were collected from the experimental group, with a feedback questionnaire at the end of the trial. The results revealed a significant group-by-time interaction in the scores of the Berg Balance Scale (p Virtual reality interventions can be an effective resource to enhance the improvement of balance in individuals with chronic stroke. © The Author(s) 2014.

Interpreting clinical trial results by deductive reasoning: In search of improved trial design.

Science.gov (United States)

Kurbel, Sven; Mihaljević, Slobodan

2017-10-01

Clinical trial results are often interpreted by inductive reasoning, in a trial design-limited manner, directed toward modifications of the current clinical practice. Deductive reasoning is an alternative in which results of relevant trials are combined in indisputable premises that lead to a conclusion easily testable in future trials. © 2017 WILEY Periodicals, Inc.

Attitudes of Patients in Developing Countries Toward Participating in Clinical Trials: A Survey of Saudi Patients Attending Primary Health Care Services

Directory of Open Access Journals (Sweden)

Lateefa O. Al-Dakhil

2016-07-01

Full Text Available Objectives: Clinical trials are experimental projects that include patients as subjects. A number of benefits are directly associated with clinical trials. Healthcare processes and outcomes can be improved with the help of clinical trials. This study aimed to assess the attitudes and beliefs of patients about their contribution to and enrolment in clinical trials. Methods: A cross-sectional study design was used for data collection and analysis. A questionnaire was developed with six categories to derive effective outcomes. Results: Of the 2000 participants approached to take part in the study, 1081 agreed. The majority of the study population was female, well educated, and unaware of clinical trials. Only 324 subjects (30.0% had previously agreed to participate in a clinical trial. The majority (87.1% were motivated to participate in clinical trials due to religious aspects. However, fear of any risk was the principal reason (79.8% that reduced their motivation to participate. Conclusions: The results of this study revealed that patients in Saudi Arabia have a low awareness and are less willing to participate in clinical trials. Different motivational factors and awareness programs can be used to increase patient participation in the future.

Random forests of interaction trees for estimating individualized treatment effects in randomized trials.

Science.gov (United States)

Su, Xiaogang; Peña, Annette T; Liu, Lei; Levine, Richard A

2018-04-29

Assessing heterogeneous treatment effects is a growing interest in advancing precision medicine. Individualized treatment effects (ITEs) play a critical role in such an endeavor. Concerning experimental data collected from randomized trials, we put forward a method, termed random forests of interaction trees (RFIT), for estimating ITE on the basis of interaction trees. To this end, we propose a smooth sigmoid surrogate method, as an alternative to greedy search, to speed up tree construction. The RFIT outperforms the "separate regression" approach in estimating ITE. Furthermore, standard errors for the estimated ITE via RFIT are obtained with the infinitesimal jackknife method. We assess and illustrate the use of RFIT via both simulation and the analysis of data from an acupuncture headache trial. Copyright © 2018 John Wiley & Sons, Ltd.

Pre-trial Intervention: The Manhattan Court Employment Project of the Vera Institute of Justice. Final Report.

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Vera Inst. of Justice, New York, NY.

The final report of an experimental pre-trial intervention program of intensive manpower services (individual and group counseling and job, training, or academic placement with the help of career developers) for selected defendants in Manhattan covers the period November 1967 through October 1970. After three years and 1,300 participants,…

Clinical Impact Research – how to choose experimental or observational intervention study?

Science.gov (United States)

Malmivaara, Antti

2016-01-01

Abstract Background: Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. Aims: This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. Methods: The new concept is based on a narrative review of the literature and on author’s idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author’s previous work on the concepts benchmarking controlled trial and system impact research (SIR). Results: The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. Conclusions: CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messagesThe new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals.The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study

Fundamentals of clinical trials

CERN Document Server

Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

2015-01-01

This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

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)

Craig Fiona F

2012-04-01

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

Imaging vascular function for early stage clinical trials using dynamic contrast-enhanced magnetic resonance imaging

Energy Technology Data Exchange (ETDEWEB)

Leach, M.O.; Orton, M. [Institute of Cancer Research and Royal Marsden NHS Foundation Trust, Cancer Research UK and EPSRC Cancer Imaging Centre, Sutton, Surrey (United Kingdom); Morgan, B. [Univ. of Leicester, College of Medicine, Biological Sciences and Psychology, Leicester (United Kingdom); Tofts, P.S. [Brighton and Sussex Medical School, Univ. of Sussex, Clinical Imaging Sciences Centre, Sussex (United Kingdom); Buckley, D.L. [University of Leeds, Division of Medical Physics, Leeds (United Kingdom); Huang, W. [Oregon Health and Science Univ., Advanced Imaging Research Centre, Portland, OR (United States); Horsfield, M.A. [Medical Physics Section, Leicester Royal Infirmary, Dept. of Cardiovascular Sciences, Leicester (United Kingdom); Chenevert, T.L. [Univ. of Michigan Health System, Ann Arbor, MI (United States); Collins, D.J. [Royal Marsden Hospital NHS Foundation Trust, Cancer Research UK and EPSRC Cancer Imaging Centre, Sutton, Surrey (United Kingdom); Jackson, A. [Univ. of Manchester, Wolfson Molecular Imaging Centre, Withington, Manchester, M20 3LJ (United Kingdom); Lomas, D. [Univ. of Cambridge, Dept. of Radiology, Cambridge (United Kingdom); Whitcher, B. [Unit 2 Greenways Business Park, Mango Solutions, Chippenham (United Kingdom); Clarke, L. [Cancer Imaging Program, Imaging Technology Development Branch, Rockville, MD (United States); Plummer, R. [Univ. of Newcastle Upon Tyne, The Medical School, Medical Oncology, Northern Inst. for Cancer Research, Newcastle Upon Tyne (United Kingdom); Judson, I. [Royal Marsden Hospital, Sutton, Surrey (United Kingdom); Jones, R. [Beatson West of Scotland Cancer Centre, Glasgow (United Kingdom); Alonzi, R. [Mount Vernon Cancer Centre, Northwood (United Kingdom); Brunner, T. [Gray Inst. for Radiation, Oncology and Biology, Oxford (United Kingdom); Koh, D.M. [Royal Marsden NHS Foundation Trust, Diagnostic Radiology, Sutton, Surrey (United Kingdom)] [and others

2012-07-15

Many therapeutic approaches to cancer affect the tumour vasculature, either indirectly or as a direct target. Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) has become an important means of investigating this action, both pre-clinically and in early stage clinical trials. For such trials, it is essential that the measurement process (i.e. image acquisition and analysis) can be performed effectively and with consistency among contributing centres. As the technique continues to develop in order to provide potential improvements in sensitivity and physiological relevance, there is considerable scope for between-centre variation in techniques. A workshop was convened by the Imaging Committee of the Experimental Cancer Medicine Centres (ECMC) to review the current status of DCE-MRI and to provide recommendations on how the technique can best be used for early stage trials. This review and the consequent recommendations are summarised here. (orig.)

Challenges and opportunities in designing clinical trials for neuromyelitis optica

Science.gov (United States)

Barron, Gerard; Behne, Jacinta M.; Bennett, Jeffery L.; Chin, Peter S.; Cree, Bruce A.C.; de Seze, Jerome; Flor, Armando; Fujihara, Kazuo; Greenberg, Benjamin; Higashi, Sayumi; Holt, William; Khan, Omar; Knappertz, Volker; Levy, Michael; Melia, Angela T.; Palace, Jacqueline; Smith, Terry J.; Sormani, Maria Pia; Van Herle, Katja; VanMeter, Susan; Villoslada, Pablo; Walton, Marc K.; Wasiewski, Warren; Wingerchuk, Dean M.; Yeaman, Michael R.

2015-01-01

Current management of neuromyelitis optica (NMO) is noncurative and only partially effective. Immunosuppressive or immunomodulatory agents are the mainstays of maintenance treatment. Safer, better-tolerated, and proven effective treatments are needed. The perceived rarity of NMO has impeded clinical trials for this disease. However, a diagnostic biomarker and recognition of a wider spectrum of NMO presentations has expanded the patient population from which study candidates might be recruited. Emerging insights into the pathogenesis of NMO have provided rationale for exploring new therapeutic targets. Academic, pharmaceutical, and regulatory communities are increasingly interested in meeting the unmet needs of patients with NMO. Clinical trials powered to yield unambiguous outcomes and designed to facilitate rapid evaluation of an expanding pipeline of experimental agents are needed. NMO-related disability occurs incrementally as a result of attacks; thus, limiting attack frequency and severity are critical treatment goals. Yet, the severity of NMO and perception that currently available agents are effective pose challenges to study design. We propose strategies for NMO clinical trials to evaluate agents targeting recovery from acute attacks and prevention of relapses, the 2 primary goals of NMO treatment. Aligning the interests of all stakeholders is an essential step to this end. PMID:25841026

Caffeinated nitric oxide-releasing lozenge improves cycling time trial performance.

Science.gov (United States)

Lee, J; Kim, H T; Solares, G J; Kim, K; Ding, Z; Ivy, J L

2015-02-01

Boosting nitric oxide production during exercise by various means has been found to improve exercise performance. We investigated the effects of a nitric oxide releasing lozenge with added caffeine (70 mg) on oxygen consumption during steady-state exercise and cycling time trial performance using a double-blinded randomized, crossover experimental design. 15 moderately trained cyclists (7 females and 8 males) were randomly assigned to ingest the caffeinated nitric oxide lozenge or placebo 5 min before exercise. Oxygen consumption and blood lactate were assessed at rest and at 50%, 65% and 75% maximal oxygen consumption. Exercise performance was assessed by time to complete a simulated 20.15 km cycling time-trial course. No significant treatment effects for oxygen consumption or blood lactate at rest or during steady-state exercise were observed. However, time-trial performance was improved by 2.1% (p<0.01) when participants consumed the nitric oxide lozenge (2,424±69 s) compared to placebo (2,476±78 s) and without a significant difference in rating of perceived exertion. These results suggest that acute supplementation with a caffeinated nitric oxide releasing lozenge may be a practical and effective means of improving aerobic exercise performance. © Georg Thieme Verlag KG Stuttgart · New York.

A cross-cultural study of acceptability and food pairing for hot sauces.