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Sample records for experimental hut trial

  1. Efficacy of Bendiocarb Used for Indoor Residual Spraying for Malaria Control in Madagascar: Results With Local Anopheles Species (Diptera: Culicidae) From Experimental Hut Trials.

    Science.gov (United States)

    Randriamaherijaona, Sanjiarizaha; Nepomichene, Thiery Nirina Jean Jose; Assoukpa, Jade; Madec, Yoann; Boyer, Sébastien

    2017-07-01

    To control malaria in Madagascar, two primary vector control interventions are being scaled up: insecticide-treated nets and indoor residual spraying of bendiocarb, which was implemented in the Malagasy Central Highlands in 2009. The current efficacy of bendiocarb against Anopheles species was evaluated in a small-scale field trial. An experimental hut trial comparing the effectiveness of bendiocarb sprayed on five substrates (cement, wood, tin, mud, and vegetative materials) was carried out against Anopheles species in two study sites located in the eastern foothills of Madagascar. No significant difference was detected in either exophily or blood-feeding rates between treated and untreated huts. The mortality rate was significantly greater in treated huts compared to untreated huts. Efficacy up to 80% was found for 5 mo posttreatment. Although effective, bendiocarb has been used for 7 yr, and therefore an alternative insecticide may be needed to avoid the emergence of resistance. © The Authors 2017. Published by Oxford University Press on behalf of Entomological Society of America. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  2. Combining indoor residual spraying with chlorfenapyr and long-lasting insecticidal bed nets for improved control of pyrethroid-resistant Anopheles gambiae: an experimental hut trial in Benin

    National Research Council Canada - National Science Library

    Ngufor, Corine; N'Guessan, Raphael; Boko, Pelagie; Odjo, Abibatou; Vigninou, Estelle; Asidi, Alex; Akogbeto, Martin; Rowland, Mark

    2011-01-01

    .... Chlorfenapyr IRS and a pyrethroid-impregnated polyester LLIN (WHO approved) were tested separately and together in experimental huts in southern Benin against pyrethroid resistant Anopheles gambiae and Culex quinquefasciatus...

  3. Olyset Duo® (a pyriproxyfen and permethrin mixture net): an experimental hut trial against pyrethroid resistant Anopheles gambiae and Culex quinquefasciatus in Southern Benin

    National Research Council Canada - National Science Library

    Ngufor, Corine; N'guessan, Raphael; Fagbohoun, Josias; Odjo, Abibatou; Malone, David; Akogbeto, Martin; Rowland, Mark

    2014-01-01

    ... effect of pyriproxyfen. The efficacy of Olyset Duo, a newly developed mixture LN containing pyriproxyfen and permethrin, was evaluated in experimental huts in southern Benin against pyrethroid resistant Anopheles gambiae...

  4. A modified experimental hut design for studying responses of disease-transmitting mosquitoes to indoor interventions: the Ifakara experimental huts.

    Directory of Open Access Journals (Sweden)

    Fredros O Okumu

    Full Text Available Differences between individual human houses can confound results of studies aimed at evaluating indoor vector control interventions such as insecticide treated nets (ITNs and indoor residual insecticide spraying (IRS. Specially designed and standardised experimental huts have historically provided a solution to this challenge, with an added advantage that they can be fitted with special interception traps to sample entering or exiting mosquitoes. However, many of these experimental hut designs have a number of limitations, for example: 1 inability to sample mosquitoes on all sides of huts, 2 increased likelihood of live mosquitoes flying out of the huts, leaving mainly dead ones, 3 difficulties of cleaning the huts when a new insecticide is to be tested, and 4 the generally small size of the experimental huts, which can misrepresent actual local house sizes or airflow dynamics in the local houses. Here, we describe a modified experimental hut design - The Ifakara Experimental Huts- and explain how these huts can be used to more realistically monitor behavioural and physiological responses of wild, free-flying disease-transmitting mosquitoes, including the African malaria vectors of the species complexes Anopheles gambiae and Anopheles funestus, to indoor vector control-technologies including ITNs and IRS. Important characteristics of the Ifakara experimental huts include: 1 interception traps fitted onto eave spaces and windows, 2 use of eave baffles (panels that direct mosquito movement to control exit of live mosquitoes through the eave spaces, 3 use of replaceable wall panels and ceilings, which allow safe insecticide disposal and reuse of the huts to test different insecticides in successive periods, 4 the kit format of the huts allowing portability and 5 an improved suite of entomological procedures to maximise data quality.

  5. Olyset Duo® (a pyriproxyfen and permethrin mixture net: an experimental hut trial against pyrethroid resistant Anopheles gambiae and Culex quinquefasciatus in Southern Benin.

    Directory of Open Access Journals (Sweden)

    Corine Ngufor

    Full Text Available Alternative compounds which can complement pyrethroids on long-lasting insecticidal nets (LN in the control of pyrethroid resistant malaria vectors are urgently needed. Pyriproxyfen (PPF, an insect growth regulator, reduces the fecundity and fertility of adult female mosquitoes. LNs containing a mixture of pyriproxyfen and pyrethroid could provide personal protection through the pyrethroid component and reduce vector abundance in the next generation through the sterilizing effect of pyriproxyfen.The efficacy of Olyset Duo, a newly developed mixture LN containing pyriproxyfen and permethrin, was evaluated in experimental huts in southern Benin against pyrethroid resistant Anopheles gambiae and Culex quinquefasciatus. Comparison was made with Olyset Net® (permethrin alone and a LN with pyriproxyfen alone (PPF LN. Laboratory tunnel tests were performed to substantiate the findings in the experimental huts.Overall mortality of wild pyrethroid resistant An. gambiae s.s. was significantly higher with Olyset Duo than with Olyset Net (50% vs. 27%, P = 0.01. Olyset DUO was more protective than Olyset Net (71% vs. 3%, P<0.001. The oviposition rate of surviving blood-fed An. gambiae from the control hut was 37% whereas none of those from Olyset Duo and PPF LN huts laid eggs. The tunnel test results were consistent with the experimental hut results. Olyset Duo was more protective than Olyset Net in the huts against wild pyrethroid resistant Cx. quinquefasciatus although mortality rates of this species did not differ significantly between Olyset Net and Olyset Duo. There was no sterilizing effect on surviving blood-fed Cx. quinquefasciatus with the PPF-treated nets.Olyset Duo was superior to Olyset Net in terms of personal protection and killing of pyrethroid resistant An. gambiae, and sterilized surviving blood-fed mosquitoes. Mixing pyrethroid and pyriproxyfen on a LN shows potential for malaria control and management of pyrethroid resistant vectors by

  6. A new long-lasting indoor residual formulation of the organophosphate insecticide pirimiphos methyl for prolonged control of pyrethroid-resistant mosquitoes: an experimental hut trial in Benin.

    Directory of Open Access Journals (Sweden)

    Mark Rowland

    Full Text Available BACKGROUND: Indoor residual spraying (IRS is widely used for malaria transmission control in sub-Saharan Africa. Resistance to pyrethroids in the mosquito Anopheles gambiae is a growing problem. There is an urgent need to develop long-lasting alternative insecticides to reduce selection pressure for pyrethroid resistance and to provide control with a single IRS application in countries with long transmission seasons. METHODS: Two capsule suspension formulations (CS of the organophosphate pirimiphos methyl were evaluated as IRS treatments in experimental huts in an area of Benin where the mosquitoes Anopheles gambiae and Culex quinquefasciatus are resistant to pyrethroids but susceptible to organophosphates. The CS formulations were tested alongside an emulsifiable concentrate (EC formulation of pirimiphos methyl and a CS formulation of the pyrethroid lambdacyhalothrin. RESULTS: The two CS formulations of pirimiphos methyl gave prolonged control of An. gambiae and Cx. quinquefasciatus. In cement huts application rates of 0.5 g/m(2 induced high mortality of An. gambiae for almost a year: overall mortality rates 87% (95% CI 82-91% and 92% (95% CI 88-94%. In mud huts application rates of 1 g/m(2 induced high mortality of An. gambiae for 10 months: overall mortality rates 75% (95% CI 69-81% and 76% (95% CI 68-83%. The EC formulation of pirimiphos methyl failed to control An. gambiae two months after spraying. The pyrethroid lambdacyhalothrin demonstrated prolonged residual activity in bioassay tests but failed to control pyrethroid resistant An. gambiae that entered the huts. Pirimiphos methyl CS was highly active against Culex quinquefasciatus and gave control for 10 months in cement huts and 6 months in mud huts. CONCLUSION: Pirimiphos methyl CS (Actellic 300 CS applied at 1 g/m(2 shows great promise for providing prolonged control of pyrethroid-resistant An gambiae and for delaying pyrethroid resistance. An alternative to DDT, giving year

  7. A new long-lasting indoor residual formulation of the organophosphate insecticide pirimiphos methyl for prolonged control of pyrethroid-resistant mosquitoes: an experimental hut trial in Benin.

    Science.gov (United States)

    Rowland, Mark; Boko, Pelagie; Odjo, Abibatou; Asidi, Alex; Akogbeto, Martin; N'Guessan, Raphael

    2013-01-01

    Indoor residual spraying (IRS) is widely used for malaria transmission control in sub-Saharan Africa. Resistance to pyrethroids in the mosquito Anopheles gambiae is a growing problem. There is an urgent need to develop long-lasting alternative insecticides to reduce selection pressure for pyrethroid resistance and to provide control with a single IRS application in countries with long transmission seasons. Two capsule suspension formulations (CS) of the organophosphate pirimiphos methyl were evaluated as IRS treatments in experimental huts in an area of Benin where the mosquitoes Anopheles gambiae and Culex quinquefasciatus are resistant to pyrethroids but susceptible to organophosphates. The CS formulations were tested alongside an emulsifiable concentrate (EC) formulation of pirimiphos methyl and a CS formulation of the pyrethroid lambdacyhalothrin. The two CS formulations of pirimiphos methyl gave prolonged control of An. gambiae and Cx. quinquefasciatus. In cement huts application rates of 0.5 g/m(2) induced high mortality of An. gambiae for almost a year: overall mortality rates 87% (95% CI 82-91%) and 92% (95% CI 88-94%). In mud huts application rates of 1 g/m(2) induced high mortality of An. gambiae for 10 months: overall mortality rates 75% (95% CI 69-81%) and 76% (95% CI 68-83%). The EC formulation of pirimiphos methyl failed to control An. gambiae two months after spraying. The pyrethroid lambdacyhalothrin demonstrated prolonged residual activity in bioassay tests but failed to control pyrethroid resistant An. gambiae that entered the huts. Pirimiphos methyl CS was highly active against Culex quinquefasciatus and gave control for 10 months in cement huts and 6 months in mud huts. Pirimiphos methyl CS (Actellic 300 CS) applied at 1 g/m(2) shows great promise for providing prolonged control of pyrethroid-resistant An gambiae and for delaying pyrethroid resistance. An alternative to DDT, giving year-round transmission control in sub-Saharan Africa is now a

  8. Olyset Duo® (a pyriproxyfen and permethrin mixture net): an experimental hut trial against pyrethroid resistant Anopheles gambiae and Culex quinquefasciatus in Southern Benin.

    Science.gov (United States)

    Ngufor, Corine; N'guessan, Raphael; Fagbohoun, Josias; Odjo, Abibatou; Malone, David; Akogbeto, Martin; Rowland, Mark

    2014-01-01

    Alternative compounds which can complement pyrethroids on long-lasting insecticidal nets (LN) in the control of pyrethroid resistant malaria vectors are urgently needed. Pyriproxyfen (PPF), an insect growth regulator, reduces the fecundity and fertility of adult female mosquitoes. LNs containing a mixture of pyriproxyfen and pyrethroid could provide personal protection through the pyrethroid component and reduce vector abundance in the next generation through the sterilizing effect of pyriproxyfen. The efficacy of Olyset Duo, a newly developed mixture LN containing pyriproxyfen and permethrin, was evaluated in experimental huts in southern Benin against pyrethroid resistant Anopheles gambiae and Culex quinquefasciatus. Comparison was made with Olyset Net® (permethrin alone) and a LN with pyriproxyfen alone (PPF LN). Laboratory tunnel tests were performed to substantiate the findings in the experimental huts. Overall mortality of wild pyrethroid resistant An. gambiae s.s. was significantly higher with Olyset Duo than with Olyset Net (50% vs. 27%, P = 0.01). Olyset DUO was more protective than Olyset Net (71% vs. 3%, Ppyriproxyfen on a LN shows potential for malaria control and management of pyrethroid resistant vectors by preventing further selection of pyrethroid resistant phenotypes.

  9. Combining indoor residual spraying with chlorfenapyr and long-lasting insecticidal bed nets for improved control of pyrethroid-resistant Anopheles gambiae: an experimental hut trial in Benin

    Directory of Open Access Journals (Sweden)

    Ngufor Corine

    2011-11-01

    Full Text Available Abstract Background Neither indoor residual spraying (IRS nor long-lasting insecticidal nets (LLINs are able to fully interrupt transmission in holoendemic Africa as single interventions. The combining of IRS and LLINs presents an opportunity for improved control and management of pyrethroid resistance through the simultaneous presentation of unrelated insecticides. Method Chlorfenapyr IRS and a pyrethroid-impregnated polyester LLIN (WHO approved were tested separately and together in experimental huts in southern Benin against pyrethroid resistant Anopheles gambiae and Culex quinquefasciatus. The bed nets were deliberately holed with either six or 80 holes to examine the effect of increasing wear and tear on protectiveness. Anopheles gambiae were genotyped for the kdr gene to assess the combination's potential to prevent the selection of pyrethroid resistance. Results The frequency of kdr was 84%. The overall mortality rates of An. gambiae were 37% and 49% with the six-hole and 80-hole LLINs, respectively, and reached 57% with chlorfenapyr IRS. Overall mortality rates were significantly higher with the combination treatments (82-83% than with the LLIN or IRS individual treatments. Blood feeding (mosquito biting rates were lowest with the 6-hole LLIN (12%, intermediate with the 80-hole LLIN (32% and highest with untreated nets (56% with the 6-hole and 54% with the 80-hole nets. Blood feeding (biting rates and repellency of mosquitoes with the combination of LLIN and chlorfenapyr IRS showed significant improvement compared to the IRS treatment but did not differ from the LLIN treatments indicating that the LLINs were the primary agents of personal protection. The combination killed significantly higher proportions of Cx. quinquefasciatus (51%, 41% than the LLIN (15%, 13% or IRS (32% treatments. Conclusion The chlorfenapyr IRS component was largely responsible for controlling pyrethroid-resistant mosquitoes and the LLIN component was largely

  10. Combining indoor residual spraying with chlorfenapyr and long-lasting insecticidal bed nets for improved control of pyrethroid-resistant Anopheles gambiae: an experimental hut trial in Benin.

    Science.gov (United States)

    Ngufor, Corine; N'Guessan, Raphael; Boko, Pelagie; Odjo, Abibatou; Vigninou, Estelle; Asidi, Alex; Akogbeto, Martin; Rowland, Mark

    2011-11-16

    Neither indoor residual spraying (IRS) nor long-lasting insecticidal nets (LLINs) are able to fully interrupt transmission in holoendemic Africa as single interventions. The combining of IRS and LLINs presents an opportunity for improved control and management of pyrethroid resistance through the simultaneous presentation of unrelated insecticides. Chlorfenapyr IRS and a pyrethroid-impregnated polyester LLIN (WHO approved) were tested separately and together in experimental huts in southern Benin against pyrethroid resistant Anopheles gambiae and Culex quinquefasciatus. The bed nets were deliberately holed with either six or 80 holes to examine the effect of increasing wear and tear on protectiveness. Anopheles gambiae were genotyped for the kdr gene to assess the combination's potential to prevent the selection of pyrethroid resistance. The frequency of kdr was 84%. The overall mortality rates of An. gambiae were 37% and 49% with the six-hole and 80-hole LLINs, respectively, and reached 57% with chlorfenapyr IRS. Overall mortality rates were significantly higher with the combination treatments (82-83%) than with the LLIN or IRS individual treatments. Blood feeding (mosquito biting) rates were lowest with the 6-hole LLIN (12%), intermediate with the 80-hole LLIN (32%) and highest with untreated nets (56% with the 6-hole and 54% with the 80-hole nets). Blood feeding (biting) rates and repellency of mosquitoes with the combination of LLIN and chlorfenapyr IRS showed significant improvement compared to the IRS treatment but did not differ from the LLIN treatments indicating that the LLINs were the primary agents of personal protection. The combination killed significantly higher proportions of Cx. quinquefasciatus (51%, 41%) than the LLIN (15%, 13%) or IRS (32%) treatments. The chlorfenapyr IRS component was largely responsible for controlling pyrethroid-resistant mosquitoes and the LLIN component was largely responsible for blood feeding inhibition and personal

  11. Efficacy of Olyset (R) Duo, a permethrin and pyriproxyfen mixture net against wild pyrethroid-resistant Anopheles gambiae s.s. from Cote d'Ivoire : an experimental hut trial

    OpenAIRE

    Koffi, A.A.; Alou, L. P. A.; Djenontin, A.; Kabran, J. P. K.; Dosso, Y.; Kone, A.; Moiroux, Nicolas; Pennetier, Cédric

    2015-01-01

    Pyrethroid resistance in malaria vectors has spread across sub-Saharan Africa. Alternative tools and molecules are urgently needed for effective vector control. One of the most promising strategies to prevent or delay the development of resistance is to use at least two molecules having unrelated modes of action in combination in the same bed net. We evaluated in experimental huts in Cote d'Ivoire, a new polyethylene long-lasting insecticidal net (LN) product, Olyset (R) Duo, incorporating pe...

  12. Efficacy of Olyset? Duo, a permethrin and pyriproxyfen mixture net against wild pyrethroid-resistant Anopheles gambiae s.s. from C?te d?Ivoire: an experimental hut trial

    OpenAIRE

    Koffi Alphonsine A; Ahoua Alou Ludovic P; Djenontin Armel; Kabran Jean-Paul K.; Dosso Youssouf; Kone Aboubacar; Moiroux Nicolas; Pennetier Cedric

    2015-01-01

    Pyrethroid resistance in malaria vectors has spread across sub-Saharan Africa. Alternative tools and molecules are urgently needed for effective vector control. One of the most promising strategies to prevent or delay the development of resistance is to use at least two molecules having unrelated modes of action in combination in the same bed net. We evaluated in experimental huts in Côte d’Ivoire, a new polyethylene long-lasting insecticidal net (LN) product, Olyset® Duo, incorporating perme...

  13. Efficacy of Olyset® Duo, a permethrin and pyriproxyfen mixture net against wild pyrethroid-resistant Anopheles gambiae s.s. from Côte d'Ivoire: an experimental hut trial.

    Science.gov (United States)

    Koffi, Alphonsine A; Ahoua Alou, Ludovic P; Djenontin, Armel; Kabran, Jean-Paul K; Dosso, Youssouf; Kone, Aboubacar; Moiroux, Nicolas; Pennetier, Cedric

    2015-01-01

    Pyrethroid resistance in malaria vectors has spread across sub-Saharan Africa. Alternative tools and molecules are urgently needed for effective vector control. One of the most promising strategies to prevent or delay the development of resistance is to use at least two molecules having unrelated modes of action in combination in the same bed net. We evaluated in experimental huts in Côte d'Ivoire, a new polyethylene long-lasting insecticidal net (LN) product, Olyset® Duo, incorporating permethrin (PER) and pyriproxyfen (PPF), an insect growth regulator (IGR). PPF alone or in combination with permethrin had a significant impact on fertility (7-12% reduction relative to control) and no effect on fecundity of wild multi-resistant An. gambiae s.s. These results triggered crucial research questions on the behaviour of targeted mosquitoes around the LN. To maximize the sterilizing effect of PPF in the combination, there would be a need for a trade-off between the necessary contact time of the insect with PPF and the surface content of the pyrethroid insecticide that is bioavailable and induces excito-repellency. © A.A. Koffi et al., published by EDP Sciences, 2015.

  14. Efficacy of Olyset® Duo, a permethrin and pyriproxyfen mixture net against wild pyrethroid-resistant Anopheles gambiae s.s. from Côte d’Ivoire: an experimental hut trial

    Science.gov (United States)

    Koffi, Alphonsine A.; Ahoua Alou, Ludovic P.; Djenontin, Armel; Kabran, Jean-Paul K.; Dosso, Youssouf; Kone, Aboubacar; Moiroux, Nicolas; Pennetier, Cedric

    2015-01-01

    Pyrethroid resistance in malaria vectors has spread across sub-Saharan Africa. Alternative tools and molecules are urgently needed for effective vector control. One of the most promising strategies to prevent or delay the development of resistance is to use at least two molecules having unrelated modes of action in combination in the same bed net. We evaluated in experimental huts in Côte d’Ivoire, a new polyethylene long-lasting insecticidal net (LN) product, Olyset® Duo, incorporating permethrin (PER) and pyriproxyfen (PPF), an insect growth regulator (IGR). PPF alone or in combination with permethrin had a significant impact on fertility (7–12% reduction relative to control) and no effect on fecundity of wild multi-resistant An. gambiae s.s. These results triggered crucial research questions on the behaviour of targeted mosquitoes around the LN. To maximize the sterilizing effect of PPF in the combination, there would be a need for a trade-off between the necessary contact time of the insect with PPF and the surface content of the pyrethroid insecticide that is bioavailable and induces excito-repellency. PMID:26489480

  15. Efficacy of Olyset® Duo, a permethrin and pyriproxyfen mixture net against wild pyrethroid-resistant Anopheles gambiae s.s. from Côte d’Ivoire: an experimental hut trial

    Directory of Open Access Journals (Sweden)

    Koffi Alphonsine A.

    2015-01-01

    Full Text Available Pyrethroid resistance in malaria vectors has spread across sub-Saharan Africa. Alternative tools and molecules are urgently needed for effective vector control. One of the most promising strategies to prevent or delay the development of resistance is to use at least two molecules having unrelated modes of action in combination in the same bed net. We evaluated in experimental huts in Côte d’Ivoire, a new polyethylene long-lasting insecticidal net (LN product, Olyset® Duo, incorporating permethrin (PER and pyriproxyfen (PPF, an insect growth regulator (IGR. PPF alone or in combination with permethrin had a significant impact on fertility (7–12% reduction relative to control and no effect on fecundity of wild multi-resistant An. gambiae s.s. These results triggered crucial research questions on the behaviour of targeted mosquitoes around the LN. To maximize the sterilizing effect of PPF in the combination, there would be a need for a trade-off between the necessary contact time of the insect with PPF and the surface content of the pyrethroid insecticide that is bioavailable and induces excito-repellency.

  16. The behaviour of mosquitoes in relation to humans under holed bednets: the evidence from experimental huts

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    Seth R Irish

    2014-11-01

    Full Text Available The physical integrity of bednets is a concern of national malaria control programs, as it is a key factor in determining the rate of replacement of bednets. It is largely assumed that increased numbers of holes will result in a loss of protection of sleepers from potentially infective bites. Experimental hut studies are valuable in understanding mosquito behaviour indoors, particularly as it relates to blood feeding and mortality. This review summarises findings from experimental hut studies, focusing on two issues: (i the effect of different numbers or sizes of holes in bednets and (ii feeding behaviour and mortality with holed nets as compared with unholed nets. As might be expected, increasing numbers and area of holes resulted in increased blood feeding by mosquitoes on sleepers. However, the presence of holes did not generally have a large effect on the mortality of mosquitoes. Successfully entering a holed mosquito net does not necessarily mean that mosquitoes spend less time in contact with the net, which could explain the lack in differences in mortality. Further behavioural studies are necessary to understand mosquito behaviour around nets and the importance of holed nets on malaria transmission.

  17. An experimental hut study to quantify the effect of DDT and airborne pyrethroids on entomological parameters of malaria transmission

    Science.gov (United States)

    2014-01-01

    Background Current malaria vector control programmes rely on insecticides with rapid contact toxicity. However, spatial repellents can also be applied to reduce man-vector contact, which might ultimately impact malaria transmission. The aim of this study was to quantify effects of airborne pyrethroids from coils and DDT used an indoor residual spray (IRS) on entomological parameters that influence malaria transmission. Methods The effect of Transfluthrin and Metofluthrin coils compared to DDT on house entry, exit and indoor feeding behaviour of Anopheles gambiae sensu lato were measured in experimental huts in the field and in the semi-field. Outcomes were deterrence - reduction in house entry of mosquitoes; irritancy or excito-repellency – induced premature exit of mosquitoes; blood feeding inhibition and effect on mosquito fecundity. Results Transfluthrin coils, Metofluthrin coils and DDT reduced human vector contact through deterrence by 38%, 30% and 8%, respectively and induced half of the mosquitoes to leave huts before feeding (56%, 55% and 48%, respectively). Almost all mosquitoes inside huts with Metofluthrin and Transfluthrin coils and more than three quarters of mosquitoes in the DDT hut did not feed, almost none laid eggs and 67%, 72% and 70% of all mosquitoes collected from Transfluthrin, Metofluthrin and DDT huts, respectively had died after 24 hours. Conclusion This study highlights that airborne pyrethroids and DDT affect a range of anopheline mosquito behaviours that are important parameters in malaria transmission, namely deterrence, irritancy/excito-repellency and blood-feeding inhibition. These effects are in addition to significant toxicity and reduced mosquito fecundity that affect mosquito densities and, therefore, provide community protection against diseases for both users and non-users. Airborne insecticides and freshly applied DDT had similar effects on deterrence, irritancy and feeding inhibition. Therefore, it is suggested that

  18. Experimental hut evaluation of the pyrrole insecticide chlorfenapyr on bed nets for the control of Anopheles arabiensis and Culex quinquefasciatus.

    Science.gov (United States)

    Mosha, F W; Lyimo, I N; Oxborough, R M; Malima, R; Tenu, F; Matowo, J; Feston, E; Mndeme, R; Magesa, S M; Rowland, M

    2008-05-01

    To determine the efficacy of chlorfenapyr against Anopheles arabiensis and Culex quinquefasciatus in East Africa and to identify effective dosages for net treatment in comparison with the commonly used pyrethroid deltamethrin. Chlorfenapyr was evaluated on bed nets in experimental huts against A. arabiensis and C. quinquefasciatus in Northern Tanzania, at application rates of 100-500 mg/m(2). In experimental huts, mortality rates in A. arabiensis were high (46.0-63.9%) for all dosages of chlorfenapyr and were similar to that of deltamethrin-treated nets. Mortality rates in C. quinquefasciatus were higher for chlorfenapyr than for deltamethrin. Despite a reputation for being slow acting, >90% of insecticide-induced mortality in laboratory tunnel tests and experimental huts occurred within 24 h, and the speed of killing was no slower than for deltamethrin-treated nets. Chlorfenapyr induced low irritability and knockdown, which explains the relatively small reduction in blood-feeding rate. Combining chlorfenapyr with a more excito-repellent pyrethroid on bed nets for improved personal protection, control of pyrethroid-resistant mosquitoes and pyrethroid resistance management would be advantageous.

  19. Loss of protection with insecticide-treated nets against pyrethroid-resistant Culex quinquefasciatus mosquitoes once nets become holed: an experimental hut study

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    Irish SR

    2008-06-01

    Full Text Available Abstract Background An important advantage of pyrethroid-treated nets over untreated nets is that once nets become worn or holed a pyrethroid treatment will normally restore protection. The capacity of pyrethroids to kill or irritate any mosquito that comes into contact with the net and prevent penetration of holes or feeding through the sides are the main reasons why treated nets continue to provide protection despite their condition deteriorating over time. Pyrethroid resistance is a growing problem among Anopheline and Culicine mosquitoes in many parts of Africa. When mosquitoes become resistant the capacity of treated nets to provide protection might be diminished, particularly when holed. An experimental hut trial against pyrethroid-resistant Culex quinquefasciatus was therefore undertaken in southern Benin using a series of intact and holed nets, both untreated and treated, to assess any loss of protection as nets deteriorate with use and time. Results There was loss of protection when untreated nets became holed; the proportion of mosquitoes blood feeding increased from 36.2% when nets were intact to between 59.7% and 68.5% when nets were holed to differing extents. The proportion of mosquitoes blood feeding when treated nets were intact was 29.4% which increased to 43.6–57.4% when nets were holed. The greater the number of holes the greater the loss of protection regardless of whether nets were untreated or treated. Mosquito mortality in huts with untreated nets was 12.9–13.6%; treatment induced mortality was less than 12%. The exiting rate of mosquitoes into the verandas was higher in huts with intact nets. Conclusion As nets deteriorate with use and become increasingly holed the capacity of pyrethroid treatments to restore protection is greatly diminished against resistant Culex quinquefasciatus mosquitoes.

  20. 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

    OpenAIRE

    Djènontin, A; Ahoua Alou, LP; Koffi, A; Zogo, B; Duarte, E.; N'Guessan, R; Moiroux, N; Pennetier, C

    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 (R) Duo, incorporating a mixture of permethrin (PER) and the insect growth regulator (IGR), pyriproxyfen (PPF). An LN containing PPF alone and a classic Olyset (R) Net were tested in parallel as positive controls. The effect of progressive number of ho...

  1. Chlorfenapyr (A Pyrrole Insecticide) Applied Alone or as a Mixture with Alpha-Cypermethrin for Indoor Residual Spraying against Pyrethroid Resistant Anopheles gambiae sl: An Experimental Hut Study in Cove, Benin.

    Science.gov (United States)

    Ngufor, Corine; Critchley, Jessica; Fagbohoun, Josias; N'Guessan, Raphael; Todjinou, Damien; Rowland, Mark

    2016-01-01

    Indoor spraying of walls and ceilings with residual insecticide remains a primary method of malaria control. Insecticide resistance in malaria vectors is a growing problem. Novel insecticides for indoor residual spraying (IRS) which can improve the control of pyrethroid resistant malaria vectors are urgently needed. Insecticide mixtures have the potential to improve efficacy or even to manage resistance in some situations but this possibility remains underexplored experimentally. Chlorfenapyr is a novel pyrrole insecticide which has shown potential to improve the control of mosquitoes which are resistant to current WHO-approved insecticides. The efficacy of IRS with chlorfenapyr applied alone or as a mixture with alpha-cypermeththrin (a pyrethroid) was evaluated in experimental huts in Cove, Southern Benin against wild free flying pyrethroid resistant Anopheles gambiae sl. Comparison was made with IRS with alpha-cypermethrin alone. Fortnightly 30-minute in situ cone bioassays were performed to assess the residual efficacy of the insecticides on the treated hut walls. Survival rates of wild An gambiae from the Cove hut site in WHO resistance bioassays performed during the trial were >90% with permethrin and deltamethrin treated papers. Mortality of free-flying mosquitoes entering the experimental huts was 4% in the control hut. Mortality with alpha-cypermethrin IRS did not differ from the control (5%, P>0.656). The highest mortality was achieved with chlorfenapyr alone (63%). The alpha-cypermethrin + chlorfenapyr mixture killed fewer mosquitoes than chlorfenapyr alone (43% vs. 63%, P<0.001). While the cone bioassays showed a more rapid decline in residual mortality with chlorfenapyr IRS to <30% after only 2 weeks, fortnightly mortality rates of wild free-flying An gambiae entering the chlorfenapyr IRS huts were consistently high (50-70%) and prolonged, lasting over 4 months. IRS with chlorfenapyr shows potential to significantly improve the control of malaria

  2. An experimental hut evaluation of Olyset® nets against anopheline mosquitoes after seven years use in Tanzanian villages

    Directory of Open Access Journals (Sweden)

    Mosha Frank W

    2008-02-01

    Full Text Available Abstract Background Long-lasting insecticidal nets (LLINs are advocated by WHO for protection against malaria. Of the three brands of LLINs currently approved by WHO, Olyset® is the only one currently granted full recommendation. With this type of LLIN, the insecticide (permethrin is incorporated into the polyethylene fibre during manufacture and diffuses from the core to the surface, thereby maintaining surface concentrations. It has not been determined for how long Olyset nets remain protective against mosquitoes in household use. Methods Examples of Olyset nets, which had been in use in Tanzanian villages for seven years, were tested in experimental huts against naturally entering Anopheles gambiae and Anopheles funestus mosquitoes. Performance was compared with new Olyset nets, conventionally treated ITNs (either newly treated with alphacypermethrin or taken from local villages after 1.5 years of use and untreated nets. All nets were artificially holed except for the seven-year Olyset nets, which had developed holes during prolonged domestic use. Results Anopheles funestus and An. gambiae in NE Tanzania are susceptible to pyrethroids. The new Olyset nets caused high mortality against An. funestus (73.9% and An. gambiae (62.7% in experimental huts. The seven-year Olyset nets caused 58.9% mortality against An. funestus and 40.0% mortality against An. gambiae. The freshly treated alphacypermethrin nets also caused high mortality against An. funestus (70.6% and An. gambiae (72.0%; this decreased to 58.4% and 69.6% respectively after 1.5 years of use. The new Olyset nets inhibited blood-feeding by 40–50%. The 7 year Olyset nets showed no feeding inhibition over that shown by the untreated nets. The alphacypermethrin treated nets failed to inhibit blood-feeding after 1.5 years of use. However iHhhdn laboratory tunnel tests samples of all types of treated net including the 7 year Olyset inhibited blood-feeding by more than 95%. Conclusion After

  3. An experimental hut evaluation of Olyset® nets against anopheline mosquitoes after seven years use in Tanzanian villages

    Science.gov (United States)

    Malima, Robert C; Magesa, Stephen M; Tungu, Patrick K; Mwingira, Victor; Magogo, Frank S; Sudi, Wema; Mosha, Frank W; Curtis, Christopher F; Maxwell, Caroline; Rowland, Mark

    2008-01-01

    Background Long-lasting insecticidal nets (LLINs) are advocated by WHO for protection against malaria. Of the three brands of LLINs currently approved by WHO, Olyset® is the only one currently granted full recommendation. With this type of LLIN, the insecticide (permethrin) is incorporated into the polyethylene fibre during manufacture and diffuses from the core to the surface, thereby maintaining surface concentrations. It has not been determined for how long Olyset nets remain protective against mosquitoes in household use. Methods Examples of Olyset nets, which had been in use in Tanzanian villages for seven years, were tested in experimental huts against naturally entering Anopheles gambiae and Anopheles funestus mosquitoes. Performance was compared with new Olyset nets, conventionally treated ITNs (either newly treated with alphacypermethrin or taken from local villages after 1.5 years of use) and untreated nets. All nets were artificially holed except for the seven-year Olyset nets, which had developed holes during prolonged domestic use. Results Anopheles funestus and An. gambiae in NE Tanzania are susceptible to pyrethroids. The new Olyset nets caused high mortality against An. funestus (73.9%) and An. gambiae (62.7%) in experimental huts. The seven-year Olyset nets caused 58.9% mortality against An. funestus and 40.0% mortality against An. gambiae. The freshly treated alphacypermethrin nets also caused high mortality against An. funestus (70.6%) and An. gambiae (72.0%); this decreased to 58.4% and 69.6% respectively after 1.5 years of use. The new Olyset nets inhibited blood-feeding by 40–50%. The 7 year Olyset nets showed no feeding inhibition over that shown by the untreated nets. The alphacypermethrin treated nets failed to inhibit blood-feeding after 1.5 years of use. However iHhhdn laboratory tunnel tests samples of all types of treated net including the 7 year Olyset inhibited blood-feeding by more than 95%. Conclusion After seven years of use

  4. 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.

  5. 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

    Directory of Open Access Journals (Sweden)

    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.

  6. 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. PMID:26489479

  7. 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.

  8. Sustainable Mobile Tourist Hut for Greenland

    DEFF Research Database (Denmark)

    Qu, Jing; Villumsen, O.; Villumsen, Arne

    Greenland is experiencing growing tourism in recent years, which increases demand for tourists’ accommodation. Small huts are a traditional way for overnight stays in Greenland due to scattered population and lack of infrastructure. However, the existing huts in Greenland cannot provide satisfact......Greenland is experiencing growing tourism in recent years, which increases demand for tourists’ accommodation. Small huts are a traditional way for overnight stays in Greenland due to scattered population and lack of infrastructure. However, the existing huts in Greenland cannot provide...... satisfactory service for tourists. Meanwhile, climate change is threatening the arctic environment and causing retreating of ice so tourist attractions might change in years. Therefore mobility and sustainability are two key factors of new tourist huts....

  9. Next Generation MK III Lightweight HUT/Hatch Assembly Project

    Data.gov (United States)

    National Aeronautics and Space Administration — A prototype Next Generation MK III Lightweight HUT/Hatch Assembly will be fabricated and delivered during Phase II. Maximum weight reduction for the Hard Upper Torso...

  10. Next Generation MK III Lightweight HUT/Hatch Assembly Project

    Data.gov (United States)

    National Aeronautics and Space Administration — The Next Generation MK III Lightweight HUT/Hatch Assembly will maximize the Hard Upper Torso - Hatch assembly weight reduction through the combination of innovative...

  11. Olyset Duo® (a Pyriproxyfen and Permethrin Mixture Net): An Experimental Hut Trial against Pyrethroid Resistant Anopheles gambiae and Culex quinquefasciatus in Southern Benin.

    OpenAIRE

    Ngufor, C; N'Guessan, R; Fagbohoun, J; Odjo, A; Malone, D.; Akogbeto, M.; Rowland, M

    2014-01-01

    Background Alternative compounds which can complement pyrethroids on long-lasting insecticidal nets (LN) in the control of pyrethroid resistant malaria vectors are urgently needed. Pyriproxyfen (PPF), an insect growth regulator, reduces the fecundity and fertility of adult female mosquitoes. LNs containing a mixture of pyriproxyfen and pyrethroid could provide personal protection through the pyrethroid component and reduce vector abundance in the next generation through the sterilizing effect...

  12. UKRAINIAN HUT IN PROVERBS AND SAYINGS

    Directory of Open Access Journals (Sweden)

    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

  13. Next-Generation MKIII Lightweight HUT/Hatch Assembly

    Science.gov (United States)

    McCarthy, Mike; Toscano, Ralph

    2013-01-01

    The MK III (H-1) carbon-graphite/ epoxy Hard Upper Torso (HUT)/Hatch assembly was designed, fabricated, and tested in the early 1990s. The spacesuit represented an 8.3 psi (˜58 kPa) technology demonstrator model of a zero prebreathe suit. The basic torso shell, brief, and hip areas of the suit were composed of a carbon-graphite/epoxy composite lay-up. In its current configuration, the suit weighs approximately 120 lb (˜54 kg). However, since future planetary suits will be designed to operate at 0.26 bar (˜26 kPa), it was felt that the suit's re-designed weight could be reduced to 79 lb (˜35 kg) with the incorporation of lightweight structural materials. Many robust, lightweight structures based on the technologies of advanced honeycomb materials, revolutionary new composite laminates, metal matrix composites, and recent breakthroughs in fullerene fillers and nanotechnology lend themselves well to applications requiring materials that are both light and strong. The major problem involves the reduction in weight of the HUT/ Hatch assembly for use in lunar and/or planetary applications, while at the same time maintaining a robust structural design. The technical objective is to research, design, and develop manufacturing methods that support fa b rica - tion of a lightweight HUT/Hatch assembly using advanced material and geometric redesign as necessary. Additionally, the lightweight HUT/Hatch assembly will interface directly with current MK III hardware. Using the new operating pressure and current MK III (H-1) interfaces as a starting block, it is planned to maximize HUT/Hatch assembly weight reduction through material selection and geometric redesign. A hard upper torso shell structure with rear-entry closure and corresponding hatch will be fabricated. The lightweight HUT/Hatch assembly will retrofit and interface with existing MK III (H-1) hardware elements, providing NASA with immediate "plug-andplay" capability. NASA crewmembers will have a lightweight

  14. Demonstration of Raman-based, dispersion-managed VCSEL technology for fibre-to-the-hut application

    Science.gov (United States)

    Rotich Kipnoo, E. K.; Kiboi Boiyo, D.; Isoe, G. M.; Chabata, T. V.; Gamatham, R. R. G.; Leitch, A. W. R.; Gibbon, T. B.

    2017-03-01

    For the first time, we experimentally investigate the use of vertical cavity surface emitting lasers (VCSELs) in the fibre-to-the-home (FTTH) flavour for Africa, known as fibre-to-the-hut. Fibre-to-the-hut is a VCSEL based passive optical network technology designed and optimized for African continent. VCSELs have attracted attention in optical communication due to its vast advantages; low power consumption, relatively cheap costs among others. A 4.25 Gb/s uncooled VCSEL is used in a dispersion managed, Raman assisted network achieving beyond 100 km of error free transmission suited for FTTHut scenario. Energy-efficient high performance VCSEL is modulated using a 27-1 PRBS pattern and the signal transmitted on a G.655 fibre utilizing the minimum attenuation window.

  15. Energy self-sufficiency of mountain huts in Triglav National Park

    Directory of Open Access Journals (Sweden)

    Urban Jensterle

    2013-12-01

    Full Text Available The electricity supply of mountain huts in Triglav National Park has changed in last 20 years. It is no longer based on fossil fuels but on renewable energy sources . In summer 2012, all analyzed mountain huts had solar cells, some also used wind energy. We are presenting a typology of mountain huts according to energy supply, their needs for energy, electricity and heat supply. Proposals and priorities were set for those mountain huts who still use fossil fuels for electricity production.

  16. 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 ...

  17. Strain in nanoscale Germanium hut clusters on Si(001) studied by x-ray diffraction

    DEFF Research Database (Denmark)

    Steinfort, A.J.; Scholte, P.M.L.O.; Ettema, A.

    1996-01-01

    Scanning tunneling microscopy and synchrotron x-ray diffraction have been used to investigate nanoscale Ge hut clusters on Si(001). We have been able to identify the contributions to the scattered x-ray intensity which arise solely from the hut clusters and have shown that x-ray diffraction can b...

  18. Crystal structure of a bicupin protein HutD involved in histidine utilization in Pseudomonas.

    Science.gov (United States)

    Gerth, M L; Liu, Y; Jiao, W; Zhang, X-X; Baker, E N; Lott, J S; Rainey, P B; Johnston, J M

    2017-08-01

    Cupins form one of the most functionally diverse superfamilies of proteins, with members performing a wide range of catalytic, non-catalytic, and regulatory functions. HutD is a predicted bicupin protein that is involved in histidine utilization (Hut) in Pseudomonas species. Previous genetic analyses have suggested that it limits the upper level of Hut pathway expression, but its mechanism of action is unknown. Here, we have determined the structure of PfluHutD at 1.74 Å resolution in several crystallization conditions, and identified N-formyl-l-glutamate (FG, a Hut pathway intermediate) as a potential ligand in vivo. Proteins 2017; 85:1580-1588. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  19. A Common Catalytic Mechanism for Proteins of the HutI Family

    Energy Technology Data Exchange (ETDEWEB)

    Tyagi,R.; Eswaramoorthy, S.; Burley, S.; Raushel, F.; Swaminathan, S.

    2008-01-01

    Imidazolonepropionase (HutI) (imidazolone-5-propanote hydrolase, EC 3.5.2.7) is a member of the amidohydrolase superfamily and catalyzes the conversion of imidazolone-5-propanoate to N-formimino-l-glutamate in the histidine degradation pathway. We have determined the three-dimensional crystal structures of HutI from Agrobacterium tumefaciens (At-HutI) and an environmental sample from the Sargasso Sea Ocean Going Survey (Es-HutI) bound to the product [N-formimino-l-glutamate (NIG)] and an inhibitor [3-(2, 5-dioxoimidazolidin-4-yl)propionic acid (DIP)], respectively. In both structures, the active site is contained within each monomer, and its organization displays the landmark feature of the amidohydrolase superfamily, showing a metal ligand (iron), four histidines, and one aspartic acid. A catalytic mechanism involving His265 is proposed on the basis of the inhibitor-bound structure. This mechanism is applicable to all HutI forms.

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

    National Research Council Canada - National Science Library

    Malouf, Nasseem M; Colagiuri, Stephen

    1995-01-01

    .... 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...

  1. Efficient Implementation of the Barnes-Hut Octree Algorithm for Monte Carlo Simulations of Charged Systems

    CERN Document Server

    Gan, Zecheng

    2013-01-01

    Computer simulation with Monte Carlo is an important tool to investigate the function and equilibrium properties of many systems with biological and soft matter materials solvable in solvents. The appropriate treatment of long-range electrostatic interaction is essential for these charged systems, but remains a challenging problem for large-scale simulations. We have developed an efficient Barnes-Hut treecode algorithm for electrostatic evaluation in Monte Carlo simulations of Coulomb many-body systems. The algorithm is based on a divide-and-conquer strategy and fast update of the octree data structure in each trial move through a local adjustment procedure. We test the accuracy of the tree algorithm, and use it to computer simulations of electric double layer near a spherical interface. It has been shown that the computational cost of the Monte Carlo method with treecode acceleration scales as $\\log N$ in each move. For a typical system with ten thousand particles, by using the new algorithm, the speed has b...

  2. 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.

  3. B14 hut at the Bronze Age settlement of Mursia (Pantelleria

    Directory of Open Access Journals (Sweden)

    Florencia Debandi

    2015-12-01

    Full Text Available This contribute deals with the explanation of the archaeological excavation of the B14 hut, that symbolizes the residential structures of the earliest phase of the village, but at the same time it can be considered exceptional for the size and for the inner setting. The stratigraphic sequence shows several episodes of transformation of inhabited space with real twisting changes that took place early in the history of the hut. In particular, in spite of the initial planning of the dwellings, each single feature adapted shape and size to different requirements among inhabitants, both productive and domestic. Ceramics of each phase of the sequence are presented showing vase types used especially in the earliest phase of the settlement. A the end of the life, the hut was completely covered by other dwellings.

  4. Wood-destroying soft rot fungi in the historic expedition huts of Antarctica.

    Science.gov (United States)

    Blanchette, Robert A; Held, Benjamin W; Jurgens, Joel A; McNew, Douglas L; Harrington, Thomas C; Duncan, Shona M; Farrell, Roberta L

    2004-03-01

    Three expedition huts in the Ross Sea region of Antarctica, built between 1901 and 1911 by Robert F. Scott and Ernest Shackleton, sheltered and stored the supplies for up to 48 men for 3 years during their explorations and scientific investigation in the South Pole region. The huts, built with wood taken to Antarctica by the early explorers, have deteriorated over the past decades. Although Antarctica has one of the coldest and driest environments on earth, microbes have colonized the wood and limited decay has occurred. Some wood in contact with the ground contained distinct microscopic cavities within secondary cell walls caused by soft rot fungi. Cadophora spp. could be cultured from decayed wood and other woods sampled from the huts and artifacts and were commonly associated with the soft rot attack. By using internal transcribed spacer sequences of ribosomal DNA and morphological characteristics, several species of Cadophora were identified, including C. malorum, C. luteo-olivacea, and C. fastigiata. Several previously undescribed Cadophora spp. also were found. At the Cape Evans and Cape Royds huts, Cadophora spp. commonly were isolated from wood in contact with the ground but were not always associated with soft rot decay. Pure cultures of Cadophora used in laboratory decay studies caused dark staining of all woods tested and extensive soft rot in Betula and Populus wood. The presence of Cadophora species, but only limited decay, suggests there is no immediate threat to the structural integrity of the huts. These fungi, however, are widely found in wood from the historic huts and have the capacity to cause extensive soft rot if conditions that are more conducive to decay become common.

  5. Experimental and trial-based study of Resilient Packet Ring

    Science.gov (United States)

    Ramnath, Vasudha; Cheng, Heng Seng; Ngoh, Lek Heng

    2002-08-01

    An experimental study of the Resilient Packet Ring (RPR) media access control (MAC) technology that is optimized for IP traffic in the metropolitan-area-network (MAN) environment is described. The study involved the deployment and trials of a RPR testbed encompassing a public optical fiber infrastructure in which Cisco Systems' Dynamic Packet Transport (DPT) Ring Technology - a prestandard RPR implementation - was used. We focus on a number of important RPR protocol features that are vital to the future success of RPR as a MAN/wide-area-network (WAN) network technology. Related research on RPR/DPT has been done so far through simulation studies only. Standardization of RPR is currently being performed by the Institute of Electrical and Electronics Engineers (IEEE) 802.17 working group and is expected to be completed in 2003. Also, we present and discuss the experiments and tests performed to investigate the key features of RPR, along with the results obtained.

  6. The Structural Insulated Panel SIP Hut: Preliminary Evaluation of Energy Efficiency and Indoor Air Quality

    Science.gov (United States)

    2015-08-19

    styrene was initially selected since most SIPs con- tain polystyrene foam. ERDC/CERL TR-15-19 50 Figure 5-3. IECU drawing – showing the location...hut construction material outgassing is performed, the TO-15 analyte list should be expanded and “library” type analyses should be performed for GC

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

    Science.gov (United States)

    Chen, Y. R.; Lim, Y. L.; Wang, M. H.; Chen, C. Y.

    2015-08-01

    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 the diversification that each conical hut has

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

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

    Early vaccine trials During the multicentre phase 1 trials, researchers demonstrated the vaccine's safety and its ability to provoke an immune response (immunogenicity). The next trials will determine the expanded safety, protective immune response, and efficacy of the vaccine with at-risk populations in Africa. The trials will ...

  9. Adequacy of different experimental designs for eucalyptus spacing trials in Portuguese environmental conditions

    Science.gov (United States)

    Paula Soares; Margarida Tome

    2000-01-01

    In Portugal, several eucalyptus spacing trials cover a relatively broad range of experimental designs: trials with a non-randomized block design with plots of different size and number of trees per plot; trials based on a non-systematic design in which spacings were randomized resulting in a factorial arrangement with plots of different size and shape and equal number...

  10. B3 and B9 huts at the Bronze Age settlement of Mursia (Pantelleria

    Directory of Open Access Journals (Sweden)

    Matteo Cantisani

    2015-12-01

    Full Text Available The hut B3 and B9, located on the southwestern edge of Sector B of the prehistoric settlement of Mursia, identify frequent structural changes inside the residential unit. The huts are characterized by architectural components and floor plans typical of the early phase of this part of the settlement and show clear traces of continuous occupation in spite of the architectural rearrangement. The reconstruction of the stratigraphic sequence, the analysis of the formation processes of the material culture, the study on the use of the space associated with specific patterns of spatial distribution of objects showed a process of formation of the archaeological record dynamic and never interrupted by clear elements of discontinuity.

  11. SMOS calibration and validation activities with airborne interferometric radiometer HUT-2D during spring 2010

    DEFF Research Database (Denmark)

    Kainulainen, J.; Rautiainen, K.; Sievinen, P.

    2010-01-01

    In this paper we present calibration and validation activities of European Space Agency’s SMOS mission, which utilize airborne interferomentric L-band radiometer system HUT-2D of the Aalto University. During spring 2010 the instrument was used to measure three SMOS validation target areas, one...... in Denmark and two in Germany. We present these areas shortly, and describe the airborne activities. We show some exemplary measurements of the radiometer system and demonstrate the studies using the data....

  12. 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

    Directory of Open Access Journals (Sweden)

    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

  13. 78 FR 36677 - Radio Experimentation and Market Trials-Streamlining Rules

    Science.gov (United States)

    2013-06-19

    ... COMMISSION 47 CFR Part 5 Radio Experimentation and Market Trials--Streamlining Rules AGENCY: Federal... the transfer of program, medical testing, and compliance testing experimental radio licenses, while... program, and innovation zone program Experimental Radio Service (ERS) licenses to complement the existing...

  14. Avian host-selection by Culex pipiens in experimental trials.

    Directory of Open Access Journals (Sweden)

    Jennifer E Simpson

    Full Text Available Evidence from field studies suggests that Culex pipiens, the primary mosquito vector of West Nile virus (WNV in the northeastern and north central United States, feeds preferentially on American robins (Turdus migratorius. To determine the contribution of innate preferences to observed preference patterns in the field, we conducted host preference trials with a known number of adult female C. pipiens in outdoor cages comparing the relative attractiveness of American robins with two common sympatric bird species, European starling, Sternus vulgaris and house sparrow, Passer domesticus. Host seeking C. pipiens were three times more likely to enter robin-baited traps when with the alternate host was a European starling (n = 4 trials; OR = 3.06; CI [1.42-6.46] and almost twice more likely when the alternative was a house sparrow (n = 8 trials; OR = 1.80; CI = [1.22-2.90]. There was no difference in the probability of trap entry when two robins were offered (n = 8 trials. Logistic regression analysis determined that the age, sex and weight of the birds, the date of the trial, starting-time, temperature, humidity, wind-speed and age of the mosquitoes had no effect on the probability of a choosing a robin over an alternate bird. Findings indicate that preferential feeding by C. pipiens mosquitoes on certain avian hosts is likely to be inherent, and we discuss the implications innate host preferences may have on enzootic WNV transmission.

  15. 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.

  16. Experimental Trials and "What Works?" in Education: The Case of Grammar for Writing

    Science.gov (United States)

    Wyse, Dominic; Torgerson, Carole

    2017-01-01

    The place of evidence to inform educational effectiveness has received increasing attention internationally in the last two decades. An important contribution to evidence-informed policy has been greater attention to experimental trials including randomised controlled trials (RCTs). The aim of this paper is to examine the use of evidence,…

  17. 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.

  18. An Antarctic hot spot for fungi at Shackleton's historic hut on Cape Royds.

    Science.gov (United States)

    Blanchette, Robert A; Held, Benjamin W; Arenz, Brett E; Jurgens, Joel A; Baltes, Nicolas J; Duncan, Shona M; Farrell, Roberta L

    2010-07-01

    The historic expedition huts located in the Ross Sea Region of the Antarctic and the thousands of artifacts left behind by the early explorers represent important cultural heritage from the "Heroic Era" of Polar exploration. The hut at Cape Royds built by Ernest Shackleton and members of the 1907-1908 British Antarctic Expedition has survived the extreme Antarctic environment for over 100 years, but recent studies have shown many forms of deterioration are causing serious problems, and microbial degradation is evident in the historic wood. Conservation work to reduce moisture at the hut required removal of fodder, wood, and many different types of organic materials from the stables area on the north side of the structure allowing large numbers of samples to be obtained for these investigations. In addition, wood from historic food storage boxes exposed in a ravine adjacent to the hut were also sampled. Fungi were cultured on several different media, and pure cultures were obtained and identified by sequencing of the internal transcribed spacer region of rDNA. From the 69 cultures of filamentous fungi obtained, the most predominant genera were Cadophora (44%) followed by Thielavia (17%) and Geomyces (15%). Other fungi found included Cladosporium, Chaetomium, and isolates identified as being in Pezizomycotina, Onygenales, Nectriaceae, and others. No filamentous basidiomycetes were found. Phylogenetic analyses of the Cadophora species showed great species diversity present revealing Cadophora malorum, Cadophora luteo-olivacea, Cadophora fastigiata, as well as Cadophora sp. 4E71-1, a C. malorum-like species, and Cadophora sp. 7R16-1, a C. fastigiata-like species. Scanning electron microscopy showed extensive decay was present in the wood samples with type 1 and type 2 forms of soft rot evident in pine and birch wood, respectively. Fungi causing decay in the historic wooden structures and artifacts are of great concern, and this investigation provides insight into the

  19. H5hut: A High-Performance I/O Library for Particle-based Simulations

    Energy Technology Data Exchange (ETDEWEB)

    Howison, Mark; Adelmann, Andreas; Bethel, E. Wes; Gsell, Achim; Oswald, Benedikt; Prabhat,

    2010-09-24

    Particle-based simulations running on large high-performance computing systems over many time steps can generate an enormous amount of particle- and field-based data for post-processing and analysis. Achieving high-performance I/O for this data, effectively managing it on disk, and interfacing it with analysis and visualization tools can be challenging, especially for domain scientists who do not have I/O and data management expertise. We present the H5hut library, an implementation of several data models for particle-based simulations that encapsulates the complexity of HDF5 and is simple to use, yet does not compromise performance.

  20. 78 FR 25137 - Radio Experimentation and Market Trials-Streamlining Rules

    Science.gov (United States)

    2013-04-29

    ... April 29, 2013 Part II Federal Communications Commission 47 CFR Parts 0, 1, 2, et al. Radio..., 1, 2, 5, 22, 73, 74, 80, 87, 90 and 101 Radio Experimentation and Market Trials--Streamlining Rules... streamlines the Commission rules to modernize the Experimental Radio Service (ERS). The rules adopted in the...

  1. 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 ...

  2. 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.

  3. Surgical experimentation and clinical trials: differences and related ethical problems

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2013-06-01

    Full Text Available Surgical techniques are not introduced into clinical practice as the result of randomised clinical trials (RCT, but usually through the gradual evolution of existing techniques or, more rarely, through audacious departures from the norm that are decided by a surgical team on the basis of experience. Sham surgery is held by some to be not only an ethically acceptable procedure but also a perfectly fit and proper one, as it could endow surgical experiments with the strict methodological and statistical precision typically associated with RCTs. This article first briefly examines some of the methodological aspects of both RCTs and surgical experiments and then offers a few considerations regarding the ethical issues raised by sham surgery.

  4. 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.

  5. Õhutõrjerelvade ost võib tuua suure teadusinvesteeringu või tellimuse / Hannes Krause

    Index Scriptorium Estoniae

    Krause, Hannes

    2006-01-01

    Õhutõrjerelvade riigihankele kutsutud relvatootjad peavad tegema ka pakkumise Eesti teaduskeskustelt või kaitsetööstuselt mitmesaja miljoni krooni eest toodete või teenuste ostmise kohta. Vastuostu põhimõtet rakendatakse Eestis esimest korda, hankel on kutsutud osalema relvatootjad MBDA Missile Systems ja Raytheon Company

  6. Experimental trials with V 4 HR and LaSota Newcastle disease virus ...

    African Journals Online (AJOL)

    Experimental trials with V 4 HR and LaSota Newcastle disease virus vaccines administered to chicks via eye drop, drinking water and commercial feed Essais experimentaux avec des vaccins V 4 HR et LaSota contre le virus de la maladie de newcastle administres a ... Bulletin of Animal Health and Production in Africa.

  7. 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

    Med, Google Scholar and Web of Science Citation Index for studies that assessed whether supposedly indistinguishable interventions (experimental and control) in randomized clinical drug trials could be distinguished based on physical properties (e.g. appearance or smell). Two persons decided on study...

  8. CMOS-compatible dense arrays of Ge quantum dots on the Si(001 surface: hut cluster nucleation, atomic structure and array life cycle during UHV MBE growth

    Directory of Open Access Journals (Sweden)

    Arapkina Larisa

    2011-01-01

    Full Text Available Abstract We report a direct observation of Ge hut nucleation on Si(001 during UHV molecular beam epitaxy at 360°C. Nuclei of pyramids and wedges were observed on the wetting layer (WL (M × N patches starting from the coverage of 5.1 Å and found to have different structures. Atomic models of nuclei of both hut species have been built as well as models of the growing clusters. The growth of huts of each species has been demonstrated to follow generic scenarios. The formation of the second atomic layer of a wedge results in rearrangement of its first layer. Its ridge structure does not repeat the nucleus. A pyramid grows without phase transitions. A structure of its vertex copies the nucleus. Transitions between hut species turned out to be impossible. The wedges contain point defects in the upper corners of the triangular faces and have preferential growth directions along the ridges. The derived structure of the {105} facet follows the paired dimer model. Further growth of hut arrays results in domination of wedges, and the density of pyramids exponentially drops. The second generation of huts arises at coverages >10 Å; new huts occupy the whole WL at coverages ~14 Å. Nanocrystalline Ge 2D layer begins forming at coverages >14 Å.

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

    Directory of Open Access Journals (Sweden)

    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

  10. 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.

  11. 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.

  12. Differential substrate subsidence of the EnviHUT project pitched extensive green roof

    Directory of Open Access Journals (Sweden)

    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.

  13. Twenty thousand-year-old huts at a hunter-gatherer settlement in eastern Jordan.

    Directory of Open Access Journals (Sweden)

    Lisa A Maher

    Full Text Available Ten thousand years before Neolithic farmers settled in permanent villages, hunter-gatherer groups of the Epipalaeolithic period (c. 22-11,600 cal BP inhabited much of southwest Asia. The latest Epipalaeolithic phase (Natufian is well-known for the appearance of stone-built houses, complex site organization, a sedentary lifestyle and social complexity--precursors for a Neolithic way of life. In contrast, pre-Natufian sites are much less well known and generally considered as campsites for small groups of seasonally-mobile hunter-gatherers. Work at the Early and Middle Epipalaeolithic aggregation site of Kharaneh IV in eastern Jordan highlights that some of these earlier sites were large aggregation base camps not unlike those of the Natufian and contributes to ongoing debates on their duration of occupation. Here we discuss the excavation of two 20,000-year-old hut structures at Kharaneh IV that pre-date the renowned stone houses of the Natufian. Exceptionally dense and extensive occupational deposits exhibit repeated habitation over prolonged periods, and contain structural remains associated with exotic and potentially symbolic caches of objects (shell, red ochre, and burnt horn cores that indicate substantial settlement of the site pre-dating the Natufian and outside of the Natufian homeland as currently understood.

  14. Understanding the molecular mechanisms of cancer prevention by dietary phytochemicals: From experimental models to clinical trials.

    Science.gov (United States)

    Maru, Girish B; Hudlikar, Rasika R; Kumar, Gaurav; Gandhi, Khushboo; Mahimkar, Manoj B

    2016-02-26

    Chemoprevention is one of the cancer prevention approaches wherein natural/synthetic agent(s) are prescribed with the aim to delay or disrupt multiple pathways and processes involved at multiple steps, i.e., initiation, promotion, and progression of cancer. Amongst environmental chemopreventive compounds, diet/beverage-derived components are under evaluation, because of their long history of exposure to humans, high tolerability, low toxicity, and reported biological activities. This compilation briefly covers and compares the available evidence on chemopreventive efficacy and probable mechanism of chemoprevention by selected dietary phytochemicals (capsaicin, curcumin, diallyl sulphide, genistein, green/black tea polyphenols, indoles, lycopene, phenethyl isocyanate, resveratrol, retinoids and tocopherols) in experimental systems and clinical trials. All the dietary phytochemicals covered in this review have demonstrated chemopreventive efficacy against spontaneous or carcinogen-induced experimental tumors and/or associated biomarkers and processes in rodents at several organ sites. The observed anti-initiating, anti-promoting and anti-progression activity of dietary phytochemicals in carcinogen-induced experimental models involve phytochemical-mediated redox changes, modulation of enzymes and signaling kinases resulting to effects on multiple genes and cell signaling pathways. Results from clinical trials using these compounds have not shown them to be chemopreventive. This may be due to our: (1) inability to reproduce the exposure conditions, i.e., levels, complexity, other host and lifestyle factors; and (2) lack of understanding about the mechanisms of action and agent-mediated toxicity in several organs and physiological processes in the host. Current research efforts in addressing the issues of exposure conditions, bioavailability, toxicity and the mode of action of dietary phytochemicals may help address the reason for observed mismatch that may ultimately

  15. TummyTrials: A Feasibility Study of Using Self-Experimentation to Detect Individualized Food Triggers.

    Science.gov (United States)

    Karkar, Ravi; Schroeder, Jessica; Epstein, Daniel A; Pina, Laura R; Scofield, Jeffrey; Fogarty, James; Kientz, Julie A; Munson, Sean A; Vilardaga, Roger; Zia, Jasmine

    2017-05-02

    Diagnostic self-tracking, the recording of personal information to diagnose or manage a health condition, is a common practice, especially for people with chronic conditions. Unfortunately, many who attempt diagnostic self-tracking have trouble accomplishing their goals. People often lack knowledge and skills needed to design and conduct scientifically rigorous experiments, and current tools provide little support. To address these shortcomings and explore opportunities for diagnostic self-tracking, we designed, developed, and evaluated a mobile app that applies a self-experimentation framework to support patients suffering from irritable bowel syndrome (IBS) in identifying their personal food triggers. TummyTrials aids a person in designing, executing, and analyzing self-experiments to evaluate whether a specific food triggers their symptoms. We examined the feasibility of this approach in a field study with 15 IBS patients, finding that participants could use the tool to reliably undergo a self-experiment. However, we also discovered an underlying tension between scientific validity and the lived experience of self-experimentation. We discuss challenges of applying clinical research methods in everyday life, motivating a need for the design of self-experimentation systems to balance rigor with the uncertainties of everyday life.

  16. The glycaemic outcomes of Cinnamon, a review of the experimental evidence and clinical trials.

    Science.gov (United States)

    Medagama, Arjuna B

    2015-10-16

    Cinnamon is currently marketed as a remedy for obesity, glucose intolerance, diabetes mellitus and dyslipidaemia. Integrative medicine is a new concept that combines conventional treatment with evidence-based complementary therapies. The aim of this review is to critically evaluate the experimental evidence available for cinnamon in improving glycaemic targets in animal models and humans. Insulin receptor auto-phosphorlylation and de-phosphorylation, glucose transporter 4 (GLUT-4 ) receptor synthesis and translocation, modulation of hepatic glucose metabolism through changes in Pyruvate kinase (PK) and Phosphenol Pyruvate Carboxikinase (PEPCK), altering the expression of PPAR (γ) and inhibition of intestinal glucosidases are some of the mechanisms responsible for improving glycaemic control with cinnamon therapy. We reviewed 8 clinical trials that used Cinnamomum cassia in aqueous or powder form in doses ranging from 500 mg to 6 g per day for a duration lasting from 40 days to 4 months as well as 2 clinical trials that used cinnamon on treatment naïve patients with pre-diabetes. An improvement in glycaemic control was seen in patients who received Cinnamon as the sole therapy for diabetes, those with pre-diabetes (IFG or IGT) and in those with high pre-treatment HbA1c. In animal models, cinnamon reduced fasting and postprandial plasma glucose and HbA1c. Cinnamon has the potential to be a useful add-on therapy in the discipline of integrative medicine in managing type 2 diabetes. At present the evidence is inconclusive and long-term trials aiming to establish the efficacy and safety of cinnamon is needed. However, high coumarin content of Cinnamomum cassia is a concern, but Cinnamomum zeylanicum with its low coumarin content would be a safer alternate.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  19. The influence of trial order on learning from reward vs. punishment in a probabilistic categorization task: experimental and computational analyses.

    Science.gov (United States)

    Moustafa, Ahmed A; Gluck, Mark A; Herzallah, Mohammad M; Myers, Catherine E

    2015-01-01

    Previous research has shown that trial ordering affects cognitive performance, but this has not been tested using category-learning tasks that differentiate learning from reward and punishment. Here, we tested two groups of healthy young adults using a probabilistic category learning task of reward and punishment in which there are two types of trials (reward, punishment) and three possible outcomes: (1) positive feedback for correct responses in reward trials; (2) negative feedback for incorrect responses in punishment trials; and (3) no feedback for incorrect answers in reward trials and correct answers in punishment trials. Hence, trials without feedback are ambiguous, and may represent either successful avoidance of punishment or failure to obtain reward. In Experiment 1, the first group of subjects received an intermixed task in which reward and punishment trials were presented in the same block, as a standard baseline task. In Experiment 2, a second group completed the separated task, in which reward and punishment trials were presented in separate blocks. Additionally, in order to understand the mechanisms underlying performance in the experimental conditions, we fit individual data using a Q-learning model. Results from Experiment 1 show that subjects who completed the intermixed task paradoxically valued the no-feedback outcome as a reinforcer when it occurred on reinforcement-based trials, and as a punisher when it occurred on punishment-based trials. This is supported by patterns of empirical responding, where subjects showed more win-stay behavior following an explicit reward than following an omission of punishment, and more lose-shift behavior following an explicit punisher than following an omission of reward. In Experiment 2, results showed similar performance whether subjects received reward-based or punishment-based trials first. However, when the Q-learning model was applied to these data, there were differences between subjects in the reward

  20. Implementation of biological nutrient removal from municipal wastewater in Finland - HUT/Savonlinna process, a challenge to the UCT process; Asumisjaeteveden biologisen ravinteiden poiston toteuttaminen Suomen oloissa - HUT/Savonlinna-prosessi UCT-prosessin haastajana

    Energy Technology Data Exchange (ETDEWEB)

    Kiuru, H. [Helsinki Univ. of Technology, Otaniemi (Finland)

    2000-07-01

    The laboratory for Environmental Engineering at the Helsinki University of Technology carried out two successive full-scale R and D projects on biological nutrient removal. As a result of these projects, Pihlajaniemi Wastewater Treatment at Savonlinna in 1991-1996, an activated sludge process, called the HUT/Savonlinna process, was developed. By making use of the organic carbon in wastewater and without any added chemicals, the process is able to reduce the phosphorus content of water by more than 90% and the nitrogen content by about 70%. Total phosphorus contents averaging less than 0.5 mg/l and total nitrogen contents of 8-12 mg/l are usual in the secondary settled wastewater. These projects demonstrated that biological nutrient removal from domestic wastewater would best be started in Finland with year-round complete nitrification. This is the most demanding phase in the removal of biological nutrients from municipal wastewater and also the most expensive way to treat municipal wastewater with the conventional aerated activated sludge process. From there, it would be natural to proceed to effective nitrogen removal by means of denitrification. In that way the operating costs of the treatment plant would be markedly reduced. Nitrogen removal could be implemented without any extension of the treatment plant beyond what would be needed for complete year-round nitrification. The chemical removal of phosphorus from wastewater carried out as simultaneous precipitation could then easily replaced by biological phosphorus removal. This procedure would bring the operating costs of the treatment plant below the level normal in the conventional treatment of municipal wastewaters with an activated sludge process with simultaneous phosphorus precipitation. For this modification the treatment plants would not even have to be enlarged. When biological nutrient removal from municipal wastewaters is implemented in Finland, the HUT/Savonlinna process will surely challenge the UCT

  1. The antiproliferative effect of kefir cell-free fraction on HuT-102 malignant T lymphocytes.

    Science.gov (United States)

    Rizk, Sandra; Maalouf, Katia; Baydoun, Elias

    2009-01-01

    Kefir is produced by adding kefir grains (a mass of proteins, polysaccharides, bacteria, and yeast) to pasteurized milk; it has been shown to control several cellular types of cancer, such as Sarcoma 180 in mice, Lewis lung carcinoma, and human mammary cancer. Human T-cell lymphotropic virus type 1 (HTLV-1) is the causative agent of adult T-cell leukemia, which is a fatal disease with no effective treatment. The current study aims at investigating the effect of a cell-free fraction of kefir on HuT-102 cells, which are HTLV-1-positive malignant T-lymphocytes. Cells were incubated with different kefir concentrations: the cytotoxicity of the compound was evaluated by determining the percentage viability of cells. The effect of all the noncytotoxic concentrations of kefir cell-free fraction on the proliferation of HuT-102 cells was then assessed. The levels of transforming growth factor (TGF)-alpha mRNA upon kefir treatment were then analyzed using reverse transcriptase polymerase chain reaction. Finally, the growth inhibitory effects of kefir on cell cycle progression and/or apoptosis were assessed by flow cytometry. The maximum cytotoxicity recorded at 80 microg/microL for 48 hours was only 43%. The percent reduction in proliferation was very significant, dose and time dependent, and reached 98% upon 60-microg/microL treatment for 24 hours. Kefir cell-free fraction caused the downregulation of TGF-alpha, which is a cytokine that induces the proliferation and replication of cells. Finally, a marked increase in cell cycle distribution was noted in the pre-G1 phase. In conclusion, kefir is effective in inhibiting proliferation and inducing apoptosis of HTLV-1-positive malignant T-lymphocytes. Therefore, further in vivo investigation is highly recommended.

  2. The effects of levamisole on experimental endometriosis: a randomized controlled trial in a rat model.

    Science.gov (United States)

    Azimirad, Afshin; Alborzi, Saeed; Kumar, Perikala Vijayananda; Zarei, Afsoon; Azimirad, Mina

    2013-12-01

    To assess the effects of levamisole on experimental endometriosis in rats through the histopathology of the implants, the blood leukocyte and lymphocyte counts and the concentrations of interleukin-6, vascular endothelial growth factor-A and tumor necrosis factor-alpha in the peritoneal environment at the three healthy, endometriotic and post-treatment milestones. Twenty-two 8-week-old Sprague-Dawley rats with normal estrus cycles were recruited in a prospective, parallel-group, placebo-controlled, double-blind, stratified-randomized animal trial with the equal allocation ratio of 1:1 challenging the efficacy of levamisole. Endometriosis was induced. After 6 weeks, laparotomy was performed to randomly excise one implant for histopathology assessment. Based on the results, they were stratified randomized and allocated (by software) to two groups of nine: levamisole (5 mg/rat/day) or placebo. After 6 weeks, necropsy was done. Two days before each laparotomy, blood samples and during the procedure, peritoneal wash were collected for ELISA. Seven rats showed success in treatment in the levamisole group, while three did in the other group. The histopathology results descriptively revealed a drop in the levamisole group, which was not meaningful statistically (0.66 ± 1.32 vs. 2.00 ± 1.50, p = 0.065). The comparisons of the post-treatment leukocytes and lymphocytes in the groups showed significant differences (11088.88 ± 5869.50 vs. 4677.77 ± 3476.98, p = 0.008, and 8588.88 ± 5721.32 vs. 3511.11 ± 2835.24, p = 0.014, respectively). The results of the cytokines were mostly, but not completely, in favor of the efficacy of levamisole. This study indicates a possible successful role for levamisole in the treatment of experimental endometriosis. Further studies to assess the effects of high dose levamisole on endometriosis are recommended.

  3. 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 (166Nmotor control patterns during gait. Consequently, the simulations did not accurately predict medial/lateral tibio-femoral force distribution and muscle activation timing. Copyright © 2013 IPEM

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

    Directory of Open Access Journals (Sweden)

    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.

  5. 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)

  6. Mosquito Nets Treated with a Mixture of Chlorfenapyr and Alphacypermethrin Control Pyrethroid Resistant Anopheles gambiae and Culex quinquefasciatus Mosquitoes in West Africa: e87710

    National Research Council Canada - National Science Library

    Corine Ngufor; Andreas A Kudom; Pelagie Boko; Abibathou Odjo; David Malone; Mark Rowland

    2014-01-01

    .... Methods The pyrrole chlorfenapyr and the pyrethroid alphacypermethrin were tested individually and as a mixture on mosquito nets in an experimental hut trial in southern Benin against pyrethroid...

  7. Mosquito nets treated with a mixture of chlorfenapyr and alphacypermethrin control pyrethroid resistant Anopheles gambiae and Culex quinquefasciatus mosquitoes in West Africa

    National Research Council Canada - National Science Library

    N'Guessan, Raphael; Ngufor, Corine; Kudom, Andreas A; Boko, Pelagie; Odjo, Abibathou; Malone, David; Rowland, Mark

    2014-01-01

    .... The pyrrole chlorfenapyr and the pyrethroid alphacypermethrin were tested individually and as a mixture on mosquito nets in an experimental hut trial in southern Benin against pyrethroid resistant...

  8. An in silico approach helped to identify the best experimental design, population, and outcome for future randomized clinical trials.

    Science.gov (United States)

    Bajard, Agathe; Chabaud, Sylvie; Cornu, Catherine; Castellan, Anne-Charlotte; Malik, Salma; Kurbatova, Polina; Volpert, Vitaly; Eymard, Nathalie; Kassai, Behrouz; Nony, Patrice

    2016-01-01

    The main objective of our work was to compare different randomized clinical trial (RCT) experimental designs in terms of power, accuracy of the estimation of treatment effect, and number of patients receiving active treatment using in silico simulations. A virtual population of patients was simulated and randomized in potential clinical trials. Treatment effect was modeled using a dose-effect relation for quantitative or qualitative outcomes. Different experimental designs were considered, and performances between designs were compared. One thousand clinical trials were simulated for each design based on an example of modeled disease. According to simulation results, the number of patients needed to reach 80% power was 50 for crossover, 60 for parallel or randomized withdrawal, 65 for drop the loser (DL), and 70 for early escape or play the winner (PW). For a given sample size, each design had its own advantage: low duration (parallel, early escape), high statistical power and precision (crossover), and higher number of patients receiving the active treatment (PW and DL). Our approach can help to identify the best experimental design, population, and outcome for future RCTs. This may be particularly useful for drug development in rare diseases, theragnostic approaches, or personalized medicine. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. 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

  10. Experimental precision in corn trials using the Papadakis method Precisão experimental dos ensaios de milho pelo método de Papadakis

    Directory of Open Access Journals (Sweden)

    Lindolfo Storck

    2010-12-01

    Full Text Available The objective of this work was to verify whether the use of the Papadakis method in competing corn hybrid trials would lead to modifications in the validity of assumptions for the mathematical model of variance analysis and for experimental precision indicators. To achieve this, corn-grain-yield data from 25 competing corn hybrid trials, performed in a design of complete randomized blocks, were examined. Each trial entailed verification of assumptions, variance analysis, hypothesis tests, statistics to identify experimental precision, and analysis using the Papadakis method. This method improves experimental precision indicators. The assumptions were valid for both analysis types (without Papadakis and with Papadakis. Mean figures for the Fasoulas differentiation index increased from 8.5 to 20.7 and selective precision rose from 0.82 to 0.92. Trials with three repetitions analyzed using the Papadakis method enabled the identification of superior corn hybrids in relation to grain yield, with 86.5% precision. To maintain the same precision in conventional analysis, four times the number of repetitions would be necessary.Objetivou-se, no trabalho, verificar se há modificações em relação ao atendimento dos pressupostos do modelo matemático da análise de variância e indicadores de precisão experimental, com a aplicação do método de Papadakis, em ensaios de competição de híbridos de milho. Para isso, foram usados os dados de produtividade de grãos de milho de 25 ensaios de competição de híbridos, conduzidos no delineamento blocos completos ao acaso. Em cada ensaio, foram realizadas: a verificação dos pressupostos, a análise de variância, os testes de hipóteses, estatísticas para identificação da precisão experimental e a análise pelo método de Papadakis. O método de Papadakis melhora os indicadores de precisão experimental. Os pressupostos não foram violados para os dois métodos de análise (sem Papadakis e com

  11. Human guinea pigs and the ethics of experimentation: the BMJ's correspondent at the Nuremberg medical trial.

    Science.gov (United States)

    Weindling, P.

    1996-01-01

    Though the Nuremberg medical trial was a United States military tribunal, British forensic pathologists supplied extensive evidence for the trial. The BMJ had a correspondent at the trial, and he endorsed a utilitarian legitimation of clinical experiments, justifying the medical research carried out under Nazism as of long term scientific benefit despite the human costs. The British supported an international medical commission to evaluate the ethics and scientific quality of German research. Medical opinions differed over whether German medical atrocities should be given publicity or treated in confidence. The BMJ's correspondent warned against medical researchers being taken over by a totalitarian state, and these arguments were used to oppose the NHS and any state control over medical research. Images Fig 1 PMID:8973237

  12. Human guinea pigs and the ethics of experimentation: the BMJ's correspondent at the Nuremberg medical trial.

    Science.gov (United States)

    Weindling, P

    1996-12-07

    Though the Nuremberg medical trial was a United States military tribunal, British forensic pathologists supplied extensive evidence for the trial. The BMJ had a correspondent at the trial, and he endorsed a utilitarian legitimation of clinical experiments, justifying the medical research carried out under Nazism as of long term scientific benefit despite the human costs. The British supported an international medical commission to evaluate the ethics and scientific quality of German research. Medical opinions differed over whether German medical atrocities should be given publicity or treated in confidence. The BMJ's correspondent warned against medical researchers being taken over by a totalitarian state, and these arguments were used to oppose the NHS and any state control over medical research.

  13. 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

  14. Promoting resilience in youth from divorced families: lessons learned from experimental trials of the New Beginnings Program.

    Science.gov (United States)

    Wolchik, Sharlene A; Schenck, Clorinda E; Sandler, Irwin N

    2009-12-01

    This article focuses on the contributions that the program of research on the New Beginnings Program (NBP) has made to understanding pathways to resilience in youth who experience parental divorce. First, the research demonstrating that divorce increases risk for mental health, physical health, and social adaptation problems is reviewed. Next, theory and research linking social environmental-level and youth-level modifiable risk factors and resilience resources to youth's postdivorce adjustment are presented. The conceptual framework underlying the NBP and the risk factors and resilience resources targeted in this program are described next. The short-term and long-term results of two experimental, randomized efficacy trials of the NBP and moderators and mediators of its effects are then presented. Analyses that examine whether youth self-systems beliefs account for the links between program-induced changes in family-level resilience resources and positive long-term program on adaptation outcomes are presented and how experimental trials can be used to further theories of resilience for youth facing adversities is discussed. The final section describes directions for future research on the NBP.

  15. 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

  16. The glycaemic outcomes of Cinnamon, a review of the experimental evidence and clinical trials

    OpenAIRE

    Medagama, Arjuna B

    2015-01-01

    Introduction Cinnamon is currently marketed as a remedy for obesity, glucose intolerance, diabetes mellitus and dyslipidaemia. Integrative medicine is a new concept that combines conventional treatment with evidence-based complementary therapies. Aim The aim of this review is to critically evaluate the experimental evidence available for cinnamon in improving glycaemic targets in animal models and humans. Results Insulin receptor auto-phosphorlylation and de-phosphorylation, glucose transport...

  17. Helping Students Make Sense of Graphs: An Experimental Trial of SmartGraphs Software

    Science.gov (United States)

    Zucker, Andrew; Kay, Rachel; Staudt, Carolyn

    2014-06-01

    Graphs are commonly used in science, mathematics, and social sciences to convey important concepts; yet students at all ages demonstrate difficulties interpreting graphs. This paper reports on an experimental study of free, Web-based software called SmartGraphs that is specifically designed to help students overcome their misconceptions regarding graphs. SmartGraphs allows students to interact with graphs and provides hints and scaffolding to help students, if they need help. SmartGraphs activities can be authored to be useful in teaching and learning a variety of topics that use graphs (such as slope, velocity, half-life, and global warming). A 2-year experimental study in physical science classrooms was conducted with dozens of teachers and thousands of students. In the first year, teachers were randomly assigned to experimental or control conditions. Data show that students of teachers who use SmartGraphs as a supplement to normal instruction make greater gains understanding graphs than control students studying the same content using the same textbooks, but without SmartGraphs. Additionally, teachers believe that the SmartGraphs activities help students meet learning goals in the physical science course, and a great majority reported they would use the activities with students again. In the second year of the study, several specific variations of SmartGraphs were researched to help determine what makes SmartGraphs effective.

  18. Conducting experimental research in marginalised populations: clinical and methodological implications from a mixed-methods randomised controlled trial in Kenya.

    Science.gov (United States)

    Lowther, Keira; Harding, Richard; Ahmed, Aabid; Gikaara, Nancy; Ali, Zippy; Kariuki, Hellen; Sherr, Lorraine; Simms, Victoria; Selman, Lucy

    2016-01-01

    Experimental studies to test interventions for people living with HIV in low- and middle-income countries are essential to ensure appropriate and effective clinical care. The implications of study participation on outcome data in such populations have been discussed theoretically, but rarely empirically examined. We aimed to explore the effects of participating in a randomised controlled trial conducted in an HIV clinic in Mombasa, Kenya. We report qualitative data from the Treatment Outcomes in Palliative Care trial, which evaluated the impact of a nurse-led palliative care intervention for HIV positive adults on antiretroviral therapy compared to standard care. Participants in both arms attended five monthly quantitative data collection appointments. Post-trial exit, 10 control and 20 intervention patients participated in semi-structured qualitative interviews, analysed using thematic analysis. We found benefit attributed to the compassion of the research team, social support, communication, completion of patient reported outcome measures (PROMs) and material support (transport reimbursement). Being treated with compassion and receiving social support enabled participants to build positive relationships with the research team, which improved mental health and well-being. Open and non-judgmental communication made participants feel accepted. Participants described how repeated completion of the PROMs was a prompt for reflection, through which they began to help themselves and self-care. Participant reimbursements relieved financial hardship and enabled them to fulfil their social responsibilities, enhancing self-worth. These findings emphasise the importance of compassion, support and effective communication in the clinical encounter, particularly in stigmatised and isolated populations, and the potential of the integration of simple PROMs to improve patient outcomes. Participation in research has unexpected positive benefits for participants, which should be

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

    Directory of Open Access Journals (Sweden)

    Fergus G Neville

    Full Text Available 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.

  20. Removal of Cardiopulmonary Resuscitation Artifacts with an Enhanced Adaptive Filtering Method: An Experimental Trial

    Directory of Open Access Journals (Sweden)

    Yushun Gong

    2014-01-01

    Full Text Available Current automated external defibrillators mandate interruptions of chest compression to avoid the effect of artifacts produced by CPR for reliable rhythm analyses. But even seconds of interruption of chest compression during CPR adversely affects the rate of restoration of spontaneous circulation and survival. Numerous digital signal processing techniques have been developed to remove the artifacts or interpret the corrupted ECG with promising result, but the performance is still inadequate, especially for nonshockable rhythms. In the present study, we suppressed the CPR artifacts with an enhanced adaptive filtering method. The performance of the method was evaluated by comparing the sensitivity and specificity for shockable rhythm detection before and after filtering the CPR corrupted ECG signals. The dataset comprised 283 segments of shockable and 280 segments of nonshockable ECG signals during CPR recorded from 22 adult pigs that experienced prolonged cardiac arrest. For the unfiltered signals, the sensitivity and specificity were 99.3% and 46.8%, respectively. After filtering, a sensitivity of 93.3% and a specificity of 96.0% were achieved. This animal trial demonstrated that the enhanced adaptive filtering method could significantly improve the detection of nonshockable rhythms without compromising the ability to detect a shockable rhythm during uninterrupted CPR.

  1. Experimental chemotherapy of Schistosomiasis III: laboratory and clinical trials with trichlorphone, an organophosphorus compound

    Directory of Open Access Journals (Sweden)

    Naftale Katz

    1968-10-01

    Full Text Available Oogram studies have been carried out on mice, hamsters, and Cebus morikeys experimentally infected with Schistosoma mansoni and treated with trichlorphone (0,0-dimethyl 1-hydroxy-2, 2, 2-trichloroethylphosphonate. In mice, despite a slight hepatic shift of schistosomes, all animais presented oogram changes when dosed, per os, at the schedules of 200, and 100 mg/kg/day × 7. In hamsters, antischistosomal activity could be detected only at toxic leveis. In monkeys, trichlorphone showed insignificant action even after oral administration of 30 mg/kg/day for 10 consecutive days. In 5 volunteers, a sharp drop in cholinesterase plasma level was observed 24 hours after a single oral dose of 7.5 mg/kg. However, cholinesterase levels returned to the initial values within a period of 11 to 27 days. Trichlorphone was then administered to 12 schistosome patients (7.5 mg/kg/day, every fort- night, × 5. One month after therapy, interruption of egg laying was observed in 6 patients. Late parasitological control showed that all treated patients continued to pass viable S. mansoni eggs with their stools.

  2. 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

    Directory of Open Access Journals (Sweden)

    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.

  3. THE CONTROL OF ANOPHELINE MOSQUITOS BY THE SPRAYING OF DELTAMETHRIN ON RAFFIA CURTAINS USED IN MINERS' HUTS IN AREAS ENDEMIC FOR MALARIA

    Directory of Open Access Journals (Sweden)

    FIGUEIREDO Regina

    1998-01-01

    Full Text Available The residual potential of an aqueous solution of Deltamethrin (FW 25 mg i.a./m2 was evaluated on raffia curtains. These are sheets of synthetic material used in the construction of huts to house miners. Experiments were conducted during 420 days and the curtains were always rolled up in the daytime and unrolled in late afternoon. Data analyzed by logarithmic regression indicated that raffia treated with Deltamethrin had higher mortality indices than that covered with DDT. The residual capacity of Deltamethrin on raffia was high. The mortality percentage was above 85% after 360 days and dropped to about 50% at 420 days. The effect of DDT was reduced after 180 days and reached zero by the end of the experiment. Based on the results of these experiments, it is recommended that Deltamethrin be used to spray raffia curtains in mining regions and other areas that are endemic for malaria.

  4. Antitumor Effects of Lidocaine on Human Breast Cancer Cells: AnIn VitroandIn VivoExperimental Trial.

    Science.gov (United States)

    Chamaraux-Tran, Thiên-Nga; Mathelin, Carole; Aprahamian, Marc; Joshi, Girish P; Tomasetto, Catherine; Diemunsch, Pierre; Akladios, Cherif

    2018-01-01

    Retrospective studies have suggested a protective effect of regional anesthesia against recurrence after cancer surgery. But confirmation of the in vivo antitumor effects is lacking. We examined the in vitro antitumor effects of lidocaine on various breast cancer cell lines and then assessed these properties in vivo at clinically relevant concentrations. In vitro experiments: normal breast epithelial cells (NBEC) MCF-10A and three tumor breast epithelial cells (TBEC) lines (MCF-7 luminal A, MDA-MB-231 triple-negative and SKBr3 HER2 positive) were exposed to increasing concentrations of lidocaine. Cell viability, migration and anchorage-independent growth were assessed by MTT, wound healing, and soft-agar growth assays. In vivo experiments: 6-week-old severe combined immunodeficient mice were injected intraperitoneally with MDA-MB-231 cells and were treated with intraperitoneal lidocaine or phosphate-buffered saline. The mice were euthanized when they reached experimental endpoints or sacrificed to determine peritoneal carcinomatosis index and global tumor volumes. Lidocaine reduced the viability of all the cell lines, inhibited migration of TBEC compared to the NBEC, and compromised the anchorage-independent growth of the triple-negative cells. Intraperitoneal lidocaine improved survival of mice with MDA-MB-231 peritoneal carcinomatosis using doses that are consistent with the current clinical settings for analgesia. In agreement with the notion that local anesthesia may be beneficial for cancer therapy, lidocaine has a protective effect against breast cancer cells in experimental studies. However, the beneficial impact of local anesthetics on breast cancer needs to be strengthened by additional preclinical and clinical trials. Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

  5. Adjuvant treatment with dexamethasone plus anti-C5 antibodies improves outcome of experimental pneumococcal meningitis: a randomized controlled trial.

    Science.gov (United States)

    Kasanmoentalib, E Soemirien; Valls Seron, Mercedes; Morgan, B Paul; Brouwer, Matthijs C; van de Beek, Diederik

    2015-08-15

    We compared adjunctive treatment with placebo, dexamethasone, anti-C5 antibodies, and the combination of dexamethasone plus anti-C5 antibodies in experimental pneumococcal meningitis. In this prospective, investigator-blinded, randomized trial, 96 mice were infected intracisternally with 10(7) CFU/ml Streptococcus pneumoniae serotype 3, treated with intraperitoneal ceftriaxone at 20 h, and randomly assigned to intraperitoneal adjunctive treatment with placebo (saline), dexamethasone, anti-C5 antibodies, or dexamethasone plus anti-C5 antibodies. The primary outcome was survival during a 72-h observational period that was analyzed with the log-rank test. Secondary outcome was clinical severity, scored on a validated scale using a linear mixed model. Mortality rates were 16 of 16 mice (100%) in the placebo group, 12 of 15 mice (80%) in the dexamethasone group, 25 of 31 mice (80%) in the anti-C5 antibody group, and 18 of 30 mice (60%) in the dexamethasone plus anti-C5 antibody group (Fisher's exact test for overall difference, P = .012). Mortality of mice treated with dexamethasone plus anti-C5 antibodies was lower compared to the anti-C5 antibody-treated mice (log-rank P = .039) and dexamethasone-treated mice (log-rank P = .040). Clinical severity scores for the dexamethasone plus anti-C5 antibody-treated mice increased more slowly (0.199 points/h) as compared to the anti-C5 antibody-treated mice (0.243 points/h, P = .009) and dexamethasone-treated mice (0.249 points/h, P = .012). Modeling of severity data suggested an additive effect of dexamethasone and anti-C5 antibodies. Adjunctive treatment with dexamethasone plus anti-C5 antibodies improves survival in severe experimental meningitis caused by S. pneumoniae serotype 3, posing an important new treatment strategy for patients with pneumococcal meningitis.

  6. Immunization with H1, HASPB1 and MML Leishmania proteins in a vaccine trial against experimental canine leishmaniasis.

    Science.gov (United States)

    Moreno, J; Nieto, J; Masina, S; Cañavate, C; Cruz, I; Chicharro, C; Carrillo, E; Napp, S; Reymond, C; Kaye, P M; Smith, D F; Fasel, N; Alvar, J

    2007-07-20

    The protective capabilities of three Leishmania recombinant proteins - histone 1 (H1) and hydrophilic acylated surface protein B1 (HASPB1) immunized singly, or together as a protein cocktail vaccine with Montanide, and the polyprotein MML immunized with MPL-SE adjuvant - were assessed in beagle dogs. Clinical examination of the dogs was carried out periodically under blinded conditions and the condition of the dogs defined as asymptomatic or symptomatic. At the end of the trial, we were able to confirm that following infection with L. infantum promastigotes, five out of eight dogs immunized with H1 Montanide, and four out of eight dogs immunized with either the combination of HASPB1 with Montanide or the combination of H1+HASPB1 with Montanidetrade mark, remained free of clinical signs, compared with two out of seven dogs immunized with the polyprotein MML and adjuvant MPL-SE, and two out of eight dogs in the control group. The results demonstrate that HASPB1 and H1 antigens in combination with Montanide were able to induce partial protection against canine leishmaniasis, even under extreme experimental challenge conditions.

  7. 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.

  8. Experimental precision in corn trials using the Papadakis method Precisão experimental dos ensaios de milho pelo método de Papadakis

    National Research Council Canada - National Science Library

    Lindolfo Storck; Sidinei José Lopes; Alberto Cargnelutti Filho; Alessandro Dal'Col Lúcio; Marcos Toebe

    2010-01-01

    The objective of this work was to verify whether the use of the Papadakis method in competing corn hybrid trials would lead to modifications in the validity of assumptions for the mathematical model...

  9. Cysteine proteinases from papaya (Carica papaya) in the treatment of experimental Trichuris suis infection in pigs: two randomized controlled trials.

    Science.gov (United States)

    Levecke, Bruno; Buttle, David J; Behnke, Jerzy M; Duce, Ian R; Vercruysse, Jozef

    2014-05-30

    Cysteine proteinases (CPs) from papaya (Carica papaya) possess anthelmintic properties against human soil-transmitted helminths (STH, Ascaris lumbricoides, Trichuris trichiura and hookworm), but there is a lack of supportive and up-to-date efficacy data. We therefore conducted two randomized controlled trials in pigs to assess the efficacy of papaya CPs against experimental infections with T. suis. First, we assessed efficacy by means of egg (ERR) and adult worm reduction rate (WRR) of a single-oral dose of 450 μmol active CPs (CP450) against low (inoculum of 300 eggs) and high (inoculum of 3,000 eggs) intensity T. suis infections and compared the efficacy with those obtained after a single-oral dose of 400 mg albendazole (ALB). In the second trial, we determined and compared the efficacy of a series of CP doses (45 [CP45], 115 [CP115], 225 [CP225], and 450 [CP450] μmol) against high intensity infections. CP450 was highly efficacious against both levels of infection intensity, resulting in ERR and WRR of more than 97%. For both levels of infection intensity, CP450 was significantly more efficacious compared to ALB by means of WRR (low infection intensity: 99.0% vs. 39.0%; high infection intensity; 97.4% vs. 23.2%). When the efficacy was assessed by ERR, a significant difference was only observed for high intensity infections, CP450 being more efficacious than ALB (98.9% vs. 59.0%). For low infection intensities, there was no significant difference in ERR between CP450 (98.3%) and ALB (64.4%). The efficacy of CPs increased as a function of increasing dose. When determined by ERR, the efficacy ranged from 2.1% for CP45 to 99.2% for CP450. For WRR the results varied from -14.0% to 99.0%, respectively. Pairwise comparison revealed a significant difference in ERR and WRR only between CP45 and CP450, the latter being more efficacious. A single dose of 450 μmol CPs provided greater efficacy against T. suis infections in pigs than a single-oral dose of 400 mg ALB

  10. Are There Scenarios When the Use of Non-Placebo-Control Groups in Experimental Trial Designs Increase Expected Value to Society?

    Science.gov (United States)

    Uyei, Jennifer; Braithwaite, R Scott

    2016-01-01

    Despite the benefits of the placebo-controlled trial design, it is limited by its inability to quantify total benefits and harms. Such trials, for example, are not designed to detect an intervention's placebo or nocebo effects, which if detected could alter the benefit-to-harm balance and change a decision to adopt or reject an intervention. In this article, we explore scenarios in which alternative experimental trial designs, which differ in the type of control used, influence expected value across a range of pretest assumptions and study sample sizes. We developed a decision model to compare 3 trial designs and their implications for decision making: 2-arm placebo-controlled trial ("placebo-control"), 2-arm intervention v. do nothing trial ("null-control"), and an innovative 3-arm trial design: intervention v. do nothing v. placebo trial ("novel design"). Four scenarios were explored regarding particular attributes of a hypothetical intervention: 1) all benefits and no harm, 2) no biological effect, 3) only biological effects, and 4) surreptitious harm (no biological benefit or nocebo effect). Scenario 1: When sample sizes were very small, the null-control was preferred, but as sample sizes increased, expected value of all 3 designs converged. Scenario 2: The null-control was preferred regardless of sample size when the ratio of placebo to nocebo effect was >1; otherwise, the placebo-control was preferred. Scenario 3: When sample size was very small, the placebo-control was preferred when benefits outweighed harms, but the novel design was preferred when harms outweighed benefits. Scenario 4: The placebo-control was preferred when harms outweighed placebo benefits; otherwise, preference went to the null-control. Scenarios are hypothetical, study designs have not been tested in a real-world setting, blinding is not possible in all designs, and some may argue the novel design poses ethical concerns. We identified scenarios in which alternative experimental study

  11. Experimental strategy of animal trial for the approval of anti-diabetic agents prior to their use in pre-human clinical trials

    Directory of Open Access Journals (Sweden)

    Vivek K. Bajpai

    2016-03-01

    Full Text Available Although several naturally available drugs have been historically used for the treatment of diabetes mellitus throughout the world, few of them have been validated by scientific criteria. Before approval of any drug developed it should pass through animal trial prior to clinical human trial, which should followed by some standard ethical rules. Recently, a large diversity of animal models have been developed to better understand the pathogenesis of diabetes mellitus, and new drugs have been introduced in the market to treat this autoimmune disease. In the present article, we demonstrated some standard handling procedure of animal trial for the approval of anti-diabetic drug, which could be helpful for both academics and industrial scientific community to conduct the animal experiments. This research also contributes in the field of ethnopharmacology to design new strategies for the development of novel drugs to treat this serious condition of diabetes mellitus that constitutes a global public health.

  12. Conducting experimental research in marginalised populations::clinical and methodological implications from a mixed-methods randomized controlled trial in Kenya

    OpenAIRE

    Lowther, K; Harding, R; Ahmed, A.; Gikaara, N; Ali, Z; Kariuki, H; Sherr, L; Simms, V; Selman, L

    2016-01-01

    ABSTRACT Experimental studies to test interventions for people living with HIV in low- and middle-income countries are essential to ensure appropriate and effective clinical care. The implications of study participation on outcome data in such populations have been discussed theoretically, but rarely empirically examined. We aimed to explore the effects of participating in a randomised controlled trial conducted in an HIV clinic in Mombasa, Kenya. We report qualitative data from the Treatment...

  13. Use of a Box Model to Estimate the Airborne Concentration of Volatilized DDT in an Experimental Hut in a Tropical Climate

    Science.gov (United States)

    2012-06-19

    cakes )  using  two...for  the  emission  chambers.    An  emission  factor  was  estimated  by  observing  the  moth   crystal   cake ...Physical  Chemical  Properties  for  DDT                  Pure  DDT  is  a  white,  crystalline   powder

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

    Science.gov (United States)

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

    2017-12-01

    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.

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

    Directory of Open Access Journals (Sweden)

    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

  16. A Comparison of the Quality of Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and Developing Countries.

    Directory of Open Access Journals (Sweden)

    David J Diemert

    2017-01-01

    , DC. Although there was no difference in the rate of correct answers between participants in Belo Horizonte and Washington, DC, there was a significant gap between participants at these two locations compared to Americaninhas (p = 0.0002 and p = 0.0001, respectively, which had a lower percentage of correct answers. Attitudes towards participating in the clinical trial also differed by site: while approximately 40% had doubts about participating in Washington, DC and Belo Horizonte, only 1.5% had concerns in Americaninhas. Finally, in Belo Horizonte and Washington, high percentages cited a desire to help others as motivation for participating, whereas in Americaninhas, the most common reason for participating was personal interest (p = 0.001. Understanding of information about a Phase 1 clinical trial of an experimental hookworm vaccine following informed consent was suboptimal, regardless of study site. Although overall there were no differences in knowledge between Brazil and the US, a lower level of understanding about the trial was seen in participants at the rural, resource-limited Brazilian site. These findings demonstrate the need for educational interventions directed at potential clinical trial participants, both in developing and developed countries, in order to improve understanding of the informed consent document.

  17. A Comparison of the Quality of Informed Consent for Clinical Trials of an Experimental Hookworm Vaccine Conducted in Developed and Developing Countries.

    Science.gov (United States)

    Diemert, David J; Lobato, Lucas; Styczynski, Ashley; Zumer, Maria; Soares, Amanda; Gazzinelli, Maria Flávia

    2017-01-01

    was no difference in the rate of correct answers between participants in Belo Horizonte and Washington, DC, there was a significant gap between participants at these two locations compared to Americaninhas (p = 0.0002 and p = 0.0001, respectively), which had a lower percentage of correct answers. Attitudes towards participating in the clinical trial also differed by site: while approximately 40% had doubts about participating in Washington, DC and Belo Horizonte, only 1.5% had concerns in Americaninhas. Finally, in Belo Horizonte and Washington, high percentages cited a desire to help others as motivation for participating, whereas in Americaninhas, the most common reason for participating was personal interest (p = 0.001). Understanding of information about a Phase 1 clinical trial of an experimental hookworm vaccine following informed consent was suboptimal, regardless of study site. Although overall there were no differences in knowledge between Brazil and the US, a lower level of understanding about the trial was seen in participants at the rural, resource-limited Brazilian site. These findings demonstrate the need for educational interventions directed at potential clinical trial participants, both in developing and developed countries, in order to improve understanding of the informed consent document.

  18. Effect of live and inactivated Lactobacillus rhamnosus GG on experimentally induced rhinovirus colds: randomised, double blind, placebo-controlled pilot trial.

    Science.gov (United States)

    Kumpu, M; Kekkonen, R A; Korpela, R; Tynkkynen, S; Järvenpää, S; Kautiainen, H; Allen, E K; Hendley, J O; Pitkäranta, A; Winther, B

    2015-01-01

    The aim of this work was to investigate the usability of an experimental rhinovirus model in probiotic trials aiming to assess effectiveness in viral infections, and to provide preliminary data of live and inactivated probiotic Lactobacillus rhamnosus GG for larger-scale trials utilising the model. 59 subjects were randomised to receive 100 ml of fruit juice supplemented with 10(9) cfu of live or heat-inactivated (by spray-drying) L. rhamnosus GG or control juice daily for six weeks. After three weeks subjects were intranasally inoculated with experimental rhinovirus. Infection rate (at least one positive culture for challenge virus on five days following inoculation or at least four-fold rise in antibody response to challenge virus) was 14/19 in the group receiving live probiotic strain and 18/20 both in the group receiving heat-inactivated probiotic strain and in the control group (P=0.36). The occurrence and severity of cold symptoms on the five days following the inoculation was lowest in the group receiving live probiotic strain (P=0.45). This trial was the first one dedicated to the investigation of the effect of probiotics using the experimental rhinovirus model. The model showed potential for demonstration of efficacy of probiotics in controlled respiratory viral infections. Occurrence and severity of cold symptoms and number of subjects with rhinovirus infection was lowest in the group receiving live L. rhamnosus GG, but differences were not statistically significant. Further large-scale studies are needed to demonstrate the efficacy of L. rhamnosus GG in respiratory infections.

  19. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes.

    Science.gov (United States)

    Sievenpiper, J L; Kendall, C W C; Esfahani, A; Wong, J M W; Carleton, A J; Jiang, H Y; Bazinet, R P; Vidgen, E; Jenkins, D J A

    2009-08-01

    Dietary non-oil-seed pulses (chickpeas, beans, peas, lentils, etc.) are a good source of slowly digestible carbohydrate, fibre and vegetable protein and a valuable means of lowering the glycaemic-index (GI) of the diet. To assess the evidence that dietary pulses may benefit glycaemic control, we conducted a systematic review and meta-analysis of randomised controlled experimental trials investigating the effect of pulses, alone or as part of low-GI or high-fibre diets, on markers of glycaemic control in people with and without diabetes. We searched MEDLINE, EMBASE, CINAHL, and the Cochrane Library for relevant controlled trials of >or=7 days. Two independent reviewers (A. Esfahani and J. M. W. Wong) extracted information on study design, participants, treatments and outcomes. Data were pooled using the generic inverse variance method and expressed as standardised mean differences (SMD) with 95% CIs. Heterogeneity was assessed by chi (2) and quantified by I (2). Meta-regression models identified independent predictors of effects. A total of 41 trials (39 reports) were included. Pulses alone (11 trials) lowered fasting blood glucose (FBG) (-0.82, 95% CI -1.36 to -0.27) and insulin (-0.49, 95% CI -0.93 to -0.04). Pulses in low-GI diets (19 trials) lowered glycosylated blood proteins (GP), measured as HbA(1c) or fructosamine (-0.28, 95% CI -0.42 to -0.14). Finally, pulses in high-fibre diets (11 trials) lowered FBG (-0.32, 95% CI -0.49 to -0.15) and GP (-0.27, 95% CI -0.45 to -0.09). Inter-study heterogeneity was high and unexplained for most outcomes, with benefits modified or predicted by diabetes status, pulse type, dose, physical form, duration of follow-up, study quality, macronutrient profile of background diets, feeding control and design. Pooled analyses demonstrated that pulses, alone or in low-GI or high-fibre diets, improve markers of longer term glycaemic control in humans, with the extent of the improvements subject to significant inter-study heterogeneity

  20. 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

    Directory of Open Access Journals (Sweden)

    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.

  1. Experimental induction of panic-like symptoms in patients with postural tachycardia syndrome.

    Science.gov (United States)

    Khurana, Ramesh K

    2006-12-01

    Patients with postural tachycardia syndrome (POTS) might be misdiagnosed with panic disorder due to shared clinical features. The first aim of our study was to investigate the relationship between symptoms of POTS and panic disorder. The second aim was to delineate clinical features distinguishing symptoms of POTS from panic disorder. A total of 11 patients with POTS and 11 control subjects participated in an IRB-approved, prospective, placebo-controlled study. The experimentally induced panic-like symptoms of POTS were systematically studied using the Acute Panic Inventory (API) questionnaire. The participants answered the questionnaire after each placebo infusion and after each of the three provoking stimuli: head-up tilt test (HUT), isoproterenol infusion (ISI), and sodium lactate infusion (SLI). API responses were summed for each subject at each time point of administration. Individual API symptoms and summed responses were analyzed for statistical significance. All patients with POTS developed symptoms of orthostatic intolerance during HUT. Pharmacologically induced symptoms subjectively mimicked spontaneous symptoms in 5 of 11 patients during ISI and in none of 11 patients during SLI. In contrast, API scores in these patients reached panic threshold in 0 of 11 following HUT, in 4 of 11 following ISI and in 4 of 11 following SLI. Individual symptoms analysis revealed that significant increase in scores was limited to the somatic symptoms of palpitations, dyspnea, and twitching or trembling. In conclusion, the symptoms of POTS are phenomenologically different and clinically distinguishable from panic disorder symptoms.

  2. A contribution to the study of acute schistosomiasis (an experimental trial Contribuição ao estudo da esquistossomose aguda (uma tentativa experimental

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    Zilton A. Andrade

    1987-09-01

    Full Text Available In an attempt to establish an experimental model of acute schistosomiasis, sequential histological changes were investigated in the skin, lung, liver and spleen of mice infected with 30 or 100 cercariae of Schistosoma mansoni according to four sets of experiments: single infection, repeated infections, unisexual infection and infection in mice born from infected mothers. Animals were killed every other day from exposure up to 50 days after infection. Only mild, isolated, focal inflammatory changes were found before the appearance of mature eggs in the liver, even when repeated infections were made. Severe changes of reactive hepatitis and splenitis appeared suddenly when the first mature eggs were deposited, around the 37th to 42nd day after infection. The mature eggs induced lytic and coagulative necrosis of hepatocytes around them which was soon followed by dense infiltration of eosinophils. So, mature egg-induced lesions appeared as the major factors in the pathogenesis of acute schistosomiasis in mice. Mice born from infected mothers were apparently able to rapidly modulate the egg-lesions, forming early fibrotic granulomas. The murine model of acute schistosomiasis appeared adequate for the study of pathology and pathogenesis of acute schistosomiasis.Numa tentativa para se estabelecer um modelo experimental para o estudo da esquistossomose aguda foram estudadas as alterações presentes na pele, pulmões, fígado e baço de comundongos submetidos a infecção com 30 ou 100 cercarias do Schistosoma mansoni e divididos em quatro tipos de experimentos: infecção simples, infecções repetidas, infecção unissexuada e infecção em animais provenientes de mães infectadas. Os animais foram sacrificados em dias alternados a partir do momento da infecção até 50 dias depois. As lesões encontadas na fase pré-postural foram discretas e poucas, mesmo quando os animais foram submetidos a infecções repetidas. As alterações mais súbitas e

  3. 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.

  4. Randomized clinical trial: efficacy and safety of PPC-5650 on experimental esophageal pain and hyperalgesia in healthy volunteers

    DEFF Research Database (Denmark)

    Olesen, Anne Estrup; Nielsen, Lecia Møller; Larsen, Isabelle Myriam

    2015-01-01

    : The study was a randomized, double-blinded, placebo-controlled, crossover trial in healthy males. Esophageal electrical, thermal, mechanical, and chemical stimulations were performed, pain perception was rated, and referred pain areas were drawn. Sensitization was induced by intraluminal esophageal acid.......58-26.47, p = 0.04), but there was no effects on thermal-, electrical-, and chemical-induced pain (all p > 0.05). PPC-5650 did not affect referred pain areas to any stimulation (all p > 0.05). Ten participants reported adverse events during the placebo treatment period, and nine participants reported adverse...

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

    DEFF Research Database (Denmark)

    Dunning, Jake; Sahr, Foday; Rojek, Amanda

    2016-01-01

    BACKGROUND: 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. METHODS AND FINDINGS: In this single-arm phase 2 trial, adults with laboratory-confirmed EVD...... 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...

  6. Nurse-led follow-up care for head and neck cancer patients: a quasi-experimental prospective trial

    NARCIS (Netherlands)

    Leeuw, J.A.M. de; Prins, J.B.; Teerenstra, S.; Merkx, M.A.W.; Marres, H.A.M.; Achterberg, T. van

    2013-01-01

    PURPOSE: The aim of this study was to compare conventional medical follow-up with follow-up containing additional nursing consultations regarding the psychosocial adjustment and health-related quality of life (HRQOL) of head and neck cancer patients. METHODS: Using a quasi-experimental design,

  7. Avaliação da precisão experimental em ensaios de competição de cultivares de soja Experimental precision evaluation of soybean cultivar yield trials

    Directory of Open Access Journals (Sweden)

    Lindolfo Storck

    2010-06-01

    Full Text Available Foram usados os dados de produtividade de grãos, de 216 ensaios de competição de cultivares de soja [Glycine max (L. Merrill], realizados no Estado do Rio Grande do Sul, nos anos agrícolas 2003/2004, 2004/2005 e 2005/2006, com o objetivo de avaliar a acurácia seletiva e outras 15 estatísticas como medidas do grau de precisão experimental dos ensaios de soja. Os valores mínimo, máximo, média, desvio padrão e coeficiente de variação foram obtidos para 16 estatísticas de cada ensaio. A estatística acurácia seletiva, AS=(1-1/F½, foi correlacionada com as demais estatísticas. Para cada faixa de precisão (baixa, moderada, alta e muito alta, segundo a estatística AS, foi obtida a frequência simples e relativa de ensaios para as diferentes categorias (ciclo, ano, significância entre blocos e entre genótipos e no geral. Segundo esta estatística, 76,4% dos ensaios de competição de cultivares de soja têm precisão alta e muito alta e apenas 6,9% tem precisão baixa. A estatística acurácia seletiva é adequada para avaliar a precisão experimental dos ensaios de competição de genótipos de soja. Descartar ensaios apenas por ter coeficiente de variação muito alto é uma atitude desaconselhável.Data of 216 soybean [Glycine max (L. Merrill] yield trials conducted in the State of Rio Grande do Sul during the 2003/04, 2004/05 and 2005/06 were used in order to evaluate the selective accuracy and other 15 statistics as a measurement of the degree of experimental precision of soybean yield trials. The minimum, maximum, average standard deviation and variation coefficient were obtained of 16 statistics in each experiment. The statistics selective accuracy, SA=(1-1/F½, was correlated with all others. For each precision class (low, moderate, high and very high according to the selective accuracy, the simple and relative frequency were obtained for each different categories (growth duration, year, significance among blocks and among

  8. Dementia care mapping in nursing homes: effects on caregiver attitudes, job satisfaction, and burnout. A quasi-experimental trial.

    Science.gov (United States)

    Dichter, Martin Nikolaus; Trutschel, Diana; Schwab, Christian Günter Georg; Haastert, Burkhard; Quasdorf, Tina; Halek, Margareta

    2017-12-01

    The Dementia Care Mapping (DCM) method is an internationally recognized complex intervention in dementia research and care for implementing person-centered care. The Leben-QD II trial aimed to evaluate the effectiveness of DCM with regard to caregivers. The nine participating nursing home units were allocated to three groups: (1) DCM method experienced ≥ 1 year, (2) DCM newly introduced during this trial, and (3) regular rating of residents' quality of life (control group). Linear mixed models were fit to cluster-aggregated data after 0, 6, and 18 months, adjusting for repeated measurements and confounders. The primary outcome was the Approaches to Dementia Questionnaire (ADQ) score; the secondary outcomes were the Copenhagen Psychosocial Questionnaire (COPSOQ) and the Copenhagen Burnout Inventory (CBI). The analysis included 201 caregivers with 290 completed questionnaires (all three data collection time points). The ADQ showed a significant time and time*intervention effect. At baseline, the estimated least-square means for the ADQ were 71.98 (group A), 72.46 (group B), and 71.15 (group C). The non-linear follow-up of group A indicated an estimated-least square means of 69.71 (T 1) and 68.97 (T 2); for group B, 72.80 (T 1) and 72.29 (T 2); and for group C, 66.43 (T 1) and 70.62 (T 2). The DCM method showed a tendency toward negatively affecting the primary and secondary outcomes; this finding could be explained by the substantial deviation in adherence to the intervention protocol.

  9. 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

  10. 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

  11. Water table response to an experimental alley farming trial: dissecting the spatial and temporal structure of the data.

    Science.gov (United States)

    Noorduijn, S L; Ghadouani, A; Vogwill, R; Smettem, K R J; Legendre, P

    2010-09-01

    Clearing vegetation for traditional agriculture diminishes native habitat and reduces plant transpiration, leading to increased groundwater recharge and onset of dryland salinization due to rising groundwater and mobilization of salt stores in the soil profile. This change in hydrology and salinity can also negatively affect biodiversity in many semiarid regions. Alternating native perennial tree belts with mono-species agriculture within the tree belt alleys is one possible system that can provide recharge control and recover some of the ecosystem services of degraded agricultural landscapes. To assess the effect of this agroforestry technique on groundwater levels, an alley farming trial was established in 1995, incorporating different combinations of belt width, alley width, and revegetation density. Transects of piezometers within each design have been monitored from October 1995 to January 2008. The data set consisted of 70 piezometers monitored on 39 dates. Two trends were observed within the raw data: An increase in water table depth with time and an increase in the range of depths monitored at the site were clearly discernible. However, simple hydrograph analysis of the data has proved unsuccessful at distinguishing the effect of the tree belts on the water table morphology. The statistical techniques employed in this paper to show the effect of the experiment on the water table were variation partitioning, principal coordinates of neighbor matrices (PCNM), and canonical redundancy analysis (RDA). The environmental variables (alley farming design, distance of piezometer from the tree belt, and percentage vegetation cover including edge effect) explained 20-30% of the variation of the transformed and detrended data for the entire site. The spatial PCNM variables explained a further 20-30% of the variation. Partitioning of the site into a northern and southern block increased the proportion of explained variation for the plots in the northern block. The

  12. 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.

    Science.gov (United States)

    Boireau, Clémence; Dufour, Barbara; Praud, Anne

    2017-01-01

    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.

  13. 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.

    Directory of Open Access Journals (Sweden)

    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.

  14. Field trial on the efficacy of an experimental fasciolicide compared with some commercial compounds in naturally infected cattle.

    Science.gov (United States)

    Vera Montenegro, Y; Ibarra Velarde, F; Quiroz Romero, H; Hernández Campos, A; Castillo, R

    2003-09-01

    The efficacy of 5-chloro-2-methylthio-6-(1-napthyloxy)-1H-benzimidazole was evaluated with three commercial fasciolicides in terms of the percentage of egg reduction in cattle. Fifty Swiss cows were selected for inclusion in the trial based on finding eggs of Fasciola hepatica in their feces. On day 0, they were blocked in five groups (G) of ten animals each according to fecal egg counts. G1 received compound alpha at 12 mg/kg p.o.; G2 triclabendazole at 12 mg/kg p.o.; G3.closantel at 3.5 mg/kg s.c.; G4 clorsulon at 2.0 mg/kg s.c. G5 animals served as untreated controls. Fecal analysis was performed on days 0, 7, 14, 21, 28, 60 and 90. Efficacy was measured on days 14 and 21. In addition, the extension and intensity effects were determined on day 60. The percentage efficacy for groups 1-4 was 98.1, 98.7, 98.2 and 97.9 on day 14 and 98.5, 97.9, 97.7 and 97.9 on day 21, respectively. No statistical differences were observed between treated groups.

  15. An exploratory clinical trial to evaluate the efficacy of an experimental dentifrice formulation in the relief of dentine hypersensitivity.

    Science.gov (United States)

    Parkinson, C; Constantin, P; Goyal, C; Hall, C

    2017-01-01

    This study aimed to investigate whether addition of an octadecene/maleic anhydride copolymer (O/MA) to a potassium nitrate (KNO3) dentifrice could facilitate delivery of potassium to dentine and enhance its efficacy in dentine hypersensitivity relief. This was a randomised, examiner-blind, controlled, parallel group study in 139 healthy subjects with at ≥2 sensitive teeth. Assessment of dentine hypersensitivity to tactile (Yeaple probe) and evaporative (air) stimuli (Schiff Sensitivity Scale, visual analogue scale [VAS]) was carried out at baseline and after 1, 2, 4 and 8 weeks twice daily treatment with an experimental 5% KNO3/3% O/MA dentifrice, a comparator 5% KNO3 dentifrice (active comparator), a 0% KNO3/3% O/MA dentifrice (placebo) and a regular fluoride dentifrice (negative control). This study was not powered to detect statistically significant differences between treatments. Across the treatment period an improvement in sensitivity to evaporative air stimulus was observed for all products and to a tactile stimulus for the potassium-containing treatments, with the greatest reductions for the experimental dentifrice (5% KNO3/3% O/MA). Reductions in sensitivity observed for the potassium-containing dentifrices compared to the placebo and negative control dentifrices were statistically significantly for Schiff sensitivity score and tactile threshold at all time-points and for VAS at Weeks 4 and 8. Trends in the study data also favoured the experimental dentifrice, compared to the active comparator dentifrice, for all clinical measures. Study treatments were generally well tolerated. This study provides initial clinical evidence to suggest that addition of a polymer excipient may enhance the anti-sensitivity efficacy of potassium-containing dentifrices. Daily use potassium-containing dentifrices are established as efficacious for the relief of dentine hypersensitivity. Inclusion of a polymer excipient in such formulations may facilitate delivery of potassium

  16. Seasonal foraging responses of beavers to sodium-enhanced foods: An experimental assessment with field feeding trials

    Science.gov (United States)

    Strules, Jennifer; DeStefano, Stephen

    2015-01-01

    Salt drive is a seasonal phenomenon common to several classes of wild herbivores. Coincident with shifts of nutrient quality when plants resume growth in the spring, sodium is secondarily lost as surplus potassium is excreted. The beaver (Castor canadensis) is an herbivore whose dietary niche closely follows that of other herbivores that are subject to salt drive, but no published studies to date have assessed the likelihood of its occurrence. To quantify if beavers experience seasonal salt drive, we designed a field experiment to measure the foraging responses of beavers to sodium-enhanced foods. We used sodium-treated (salted) and control (no salt) food items (aspen [Populus tremuloides] and pine [Pinus spp.] sticks) during monthly feeding trials at beaver-occupied wetlands. If conventional ontogeny of salt drive was operant, we expected to observe greater utility of sodium-treated food items by beavers in May and June. Further, if water lilies (Nymphaea spp. and Nuphar spp.) supply beavers with sodium to meet dietary requirements as is widely speculated, we expected foraging responses to sodium-treated food items at wetlands where water lilies were absent to be greater than at wetlands where water lily was present. Aspen was selected by beavers in significantly greater amounts than pine. There was no difference between the mean percent consumed of salted and control aspen sticks by beavers at lily and non-lily wetlands, and no differences in temporal consumption associated with salted or control pine sticks at either wetland type. Salted pine was consumed in greater amounts than unsalted pine. We propose that the gastrointestinal or renal physiology of beavers may preclude solute loss, thereby preventing salt drive.

  17. Experimental protocol of a randomized controlled clinical trial investigating exercise, subclinical atherosclerosis, and walking mobility in persons with multiple sclerosis.

    Science.gov (United States)

    Griffith, Garett; Klaren, Rachel E; Motl, Robert W; Baynard, Tracy; Fernhall, Bo

    2015-03-01

    This randomized controlled trial (RCT) will investigate the effects of a home-based aerobic exercise training regimen (i.e., cycle ergometry) on subclinical atherosclerosis and walking mobility in persons with multiple sclerosis (MS) and minimal disability. This RCT will recruit 54 men and women who have an Expanded Disability Status Scale characteristic of the 1st stage of MS (i.e., 0-4.0) to participate in a 3 month exercise or stretching intervention, with assessments of subclinical atherosclerosis and walking mobility conducted at baseline, week 6 (midpoint), and week 12 (conclusion) of the program. The exercise intervention will consist of 3 days/week of cycling, with a gradual increase of duration followed by an increase in intensity across the 3 month period. The attention-control condition will incorporate stretching activities and will require the same contact time commitment as the exercise condition. Both study groups will participate in weekly video chat sessions with study personnel in order to monitor and track program adherence. Primary outcomes will consist of assessments of vascular structure and function, as well as several walking tasks. Additional outcomes will include questionnaires, cardiorespiratory fitness assessment, and a 1-week free-living physical activity assessment. This investigation will increase understanding of the role of aerobic exercise as part of a treatment plan for managing subclinical atherosclerosis and improving walking mobility persons in the 1st stage of MS. Overall, this study design has the potential to lead to effective aerobic exercise intervention strategies for this population and improve program adherence. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. Neuropharmacological Properties of Withania somnifera - Indian Ginseng: An Overview on Experimental Evidence with Emphasis on Clinical Trials and Patents.

    Science.gov (United States)

    Yenisetti, Sarat C; Manjunath, M J; Muralidhara, C

    2016-01-01

    Owing to the increasing aged population globally, disorders and diseases of the CNS are anticipated to increase and profoundly impact the health care. As these neurodegenerative diseases (NDD) are complex, multifactorial and do not have identified etiological factors, unfortunately, drugs developed for the purpose have not met with the expected success. Hence, there has been a constant demand for the development of natural therapeutic adjuvants which are safe and possess the potential to attenuate multiple pathways. Numerous herbal/natural products have been used as therapeutics in Ayurvedic system of medicine to treat NDD and other memory-related disorders. Withania somnifera (Ashwagandha, WS), popularly called as "Indian Ginseng" is one such plant which possesses a variety of beneficial neuropharmacological properties. In this review, we have attempted to review critically the existing literature and patents related to the neuroprotective efficacy of WS roots and the underlying mechanism/s. Standardized extracts of Withania somnifera (WS) have been demonstrated to possess multidimensional neuromodulatory effects both in vitro and animal models. The spectrum of effects evidenced comprises of attenuation of oxidative damage by enhancing the antioxidant defense system with concomitant enhancement of the expression of marker proteins responsible for growth, differentiation and communication of neural cells. Specific effects of WS are attributable to its potential to modulate neurotrophic factors, cytoskeletal elements, cell adhesion molecules and synaptic proteins. Generation of new data by employing systematic contemporary approaches such as bioinformatics, molecular docking studies, identification of specific gene targets and epigenetic regulation would provide the necessary impetus to validate fully the neurotherapeutic potential of the phytochemicals derived from WS. More importantly, well-designed clinical trials are required to exploit the neuromodulatory

  19. 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

  20. Time course of copeptin during a model of experimental pain and hyperalgesia: A randomised volunteer crossover trial.

    Science.gov (United States)

    Mauermann, Eckhard; Blum, Claudine A; Lurati Buse, Giovanna; Bandschapp, Oliver; Ruppen, Wilhelm

    2017-05-01

    A reliable biomarker for quantifying pain or hyperalgesia has yet to be found. A surrogate marker of arginine vasopressin, copeptin, is elevated in a number of states of physiological and psychological stress and may have a role in quantifying pain and/or hyperalgesia. To evaluate copeptin as a biomarker for pain or hyperalgesia developing after 120 min of sustained electrical stimulation. Secondary analysis of a randomised, double-blinded, crossover trial. Single, tertiary university hospital from September 2014 to January 2015. A total of 16 healthy, opioid-naïve white men with no confounding medication or history of pain. Copeptin and cortisol were measured five times during an established model of transdermal electrical stimulation designed to assess pain and hyperalgesia. The primary outcome was the change in copeptin concentration after 120 min of sustained electrical stimulation. Secondary outcomes were copeptin and cortisol concentrations after a subsequent period of rest and analyses of copeptin and cortisol concentrations were made in high-dose and low-dose fentanyl groups separately. Total copeptin concentrations were not significantly elevated after 120 min [9.15 pmol l (interquartile ranges (IQR), 3.45 to 35.45 pmol l); P = 0.150] compared with baseline [6.15 pmol l (IQR, 3.60 to 10.62 pmol l)]. In the high-dose fentanyl group, there was a significant increase in copeptin within individuals [P = 0.001; median, 37.9 pmol l (IQR, 8.1 to 62 pmol l)] after 120 min, and in the low-dose fentanyl group a significant decrease in copeptin concentrations within individuals [P = 0.006; median, 4.7 pmol l (IQR, 3.13 to 9.35 pmol l)]. No correlation between copeptin concentration and either the area under the pain curve or area under the hyperalgesia curve could be found, indicating that the observed differences may be due to other fentanyl-mediated effects. Copeptin concentrations do not appear to be associated

  1. Sensory trigeminal ULF-TENS stimulation reduces HRV response to experimentally induced arithmetic stress: A randomized clinical trial.

    Science.gov (United States)

    Monaco, Annalisa; Cattaneo, Ruggero; Ortu, Eleonora; Constantinescu, Marian Vladimir; Pietropaoli, Davide

    2017-05-01

    Ultra Low Frequency Transcutaneous Electric Nervous Stimulation (ULF-TENS) is extensively used for pain relief and for the diagnosis and treatment of temporomandibular disorders (TMD). In addition to its local effects, ULF-TENS acts on the autonomic nervous system (ANS), with particular reference to the periaqueductal gray (PAG), promoting the release of endogenous opioids and modulating descending pain systems. It has been suggested that the PAG participates in the coupling between the emotional stimulus and the appropriate behavioral autonomic response. This function is successfully investigated by HRV. Therefore, our goal is to investigate the effects of trigeminal ULF-TENS stimulation on autonomic behavior in terms of HRV and respiratory parameters during an experimentally-induced arithmetic stress test in healthy subjects. Thirty healthy women between 25 and 35years of age were enrolled and randomly assigned to either the control (TENS stimulation off) or test group (TENS stimulation on). Heart (HR, LF, HF, LF/HF ratio, DET, RMSSD, PNN50, RR) and respiratory (BR) rate were evaluated under basal, T1 (TENS off/on), and stress (mathematical task) conditions. Results showed that HRV parameters and BR significantly changed during the arithmetic stress paradigm (pTENS and control group could be discriminated only by non-linear HRV data, namely RR and DET (p=0.038 and p=0.027, respectively). During the arithmetic task, LF/HF ratio was the most sensitive parameter to discriminate between groups (p=0.019). Our data suggest that trigeminal sensory ULF-TENS reduces the autonomic response in terms of HRV and BR during acute mental stress in healthy subjects. Future directions of our work aim at applying the HRV and BR analysis, with and without TENS stimulation, to individuals with dysfunctional ANS among those with TMD. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Effects of interferential therapy parameter combinations upon experimentally induced pain in pain-free participants: a randomized controlled trial.

    Science.gov (United States)

    Dounavi, Myrto D; Chesterton, Linda S; Sim, Julius

    2012-07-01

    Little evidence exists regarding parameter selection for hypoalgesia using interferential therapy (IFT). This study investigated segmental and extrasegmental hypoalgesic effects of different IFT parameter combinations upon experimentally induced pressure pain threshold (PPT) in pain-free volunteers. The participants were randomly assigned to 6 groups: control, placebo, bipolar constant amplitude modulation frequency (AMF), bipolar sweep AMF, quadripolar constant AMF, and quadripolar sweep AMF. The study was conducted in a university laboratory. One hundred eighty adults who were healthy and pain-free participated in the study. Interferential therapy was delivered to all groups at high, to-tolerance intensity and at high AMF. Stimulation to the dominant forearm was delivered for 30 minutes, with monitoring for a further 30 minutes. Pain pressure threshold was measured at the area of first dorsal interosseous muscle of the dominant and nondominant hands (segmental measurements) and over the tibialis anterior muscle (extrasegmental measurement) at baseline and at 10-minute intervals using a pressure algometer. Square root transformed PPT data were analyzed using repeated-measures analysis of variance. There was a significant change in PPT over time, but no significant between-subjects difference in segmental or extrasegmental PPT between any of the IFT groups and the placebo or control group. Thus, IFT delivered in any of these parameter combinations did not significantly affect the PPT of pain-free participants compared with the control or placebo group. Success of blinding was not evaluated. This study showed that IFT delivered at high, to-tolerance intensity and high AMF does not produce significant segmental and extrasegmental hypoalgesic effects on PPT in participants who were healthy compared with a control or placebo group. Further research is warranted to investigate the hypoalgesic effect of different IFT parameter combinations and to explain its possible

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

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    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.

  4. 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

  5. Effect of compost supplies on soil bulk density and aggregate stability. Results from a six years trial in two experimental fields in Northern Italy

    Science.gov (United States)

    Calzolari, C.; Ungaro, F.; Salvador, P.; Torri, D.

    2009-04-01

    Results of a long term trial (2002-2007) on the effect of different organic amendments on topsoil structural properties at the end of the 6th year are presented. Two soils located in two experimental farms of the Emilia-Romagna region (Northern Italy), namely a silty clay loam Haplic Calcisol under sorghum (Sorghum bicolor, L.) continuous cropping, and a silty Calcaric Cambisols under peach (Persica vulgaris, Mill.), have been treated with a different amount of organic amendments. Four different treatments were tested plus control: manure (10 Mg ha-1 y-1), low input compost (5 and 10 Mg ha-1 y-1), high input compost (10 and 40 Mg ha-1 y-1), and no-tillage. In all the plots soil samples were collected three times every year: at the beginning of the growing season, at full crop coverage and after harvest. At each time, samples were collected in three replicates and soil bulk density and aggregate stability were measured. At the end of the 6 years trial 930 bulk density and 405 aggregate stability measurements were made available. The influence of organic amendments on soil physical properties is different according to the considered soil property and to the different soils. Soil bulk density (BD) shows clear and statistically significant differences among the tested theses, all with a marked seasonality and distinct temporal trends. The overall trends observed in the two soils are coherent with the amount of organic matter distributed in the different theses and with the field operations (tillage mainly), but with a short term effect. More important, over the period of observation and within each year, the treatments exhibit cyclical variations due to climate seasonality. Among the treatments, that with distribution of manure exhibits the weakest seasonal variations and a substantially stable general trend, with BD values slightly lower than those observed for the control. Different effects are also observed on soil aggregates stability, but also in this case a

  6. Web-based Mindfulness-based Cognitive Therapy for reducing residual depressive symptoms: An open trial and quasi-experimental comparison to propensity score matched controls.

    Science.gov (United States)

    Dimidjian, Sona; Beck, Arne; Felder, Jennifer N; Boggs, Jennifer M; Gallop, Robert; Segal, Zindel V

    2014-12-01

    Mindfulness-based Cognitive Therapy (MBCT) has been shown to effectively prevent relapse and reduce residual depressive symptoms (RDS), yet it faces barriers to dissemination. The present study examined Mindful Mood Balance (MMB), the first web-based approach to deliver the core content of MBCT. Of the 107 recurrently depressed individuals screened, 100 elected to enroll in the study and received MMB in an 8-session open trial with 6-month follow-up. Outcomes included depressive symptom severity, rumination and mindful awareness, and program engagement. A quasi-experimental comparison between MMB participants and propensity matched case-controls receiving usual depression care (UDC) (N = 100) also was conducted. The full sample and the subgroup with residual depressive symptoms (N = 42) showed significantly reduced depressive severity, which was sustained over six months, and improvement on rumination and mindfulness. Examination of acceptability of MMB indicated that 42% of participants within the full sample and 36% of the RDS subgroup completed all 8 sessions and 53% within the full sample and 50% within the RDS subgroup completed at least 4 sessions, and that participants engaged with daily mindfulness practice. MMB also was associated with significant reduction in RDS severity as compared to quasi-experimental propensity matched controls. Although the use of a non-randomized design, with potential unmeasured differences between groups, and short interval of clinical follow-up were limitations, findings from this study support the web-based delivery of MBCT and suggest clinical benefits for participants with histories of depression and with RDS, relative to those receiving usual care alone. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Experimental pain ratings and reactivity of cortisol and soluble tumor necrosis factor-α receptor II following a trial of hypnosis: results of a randomized controlled pilot study.

    Science.gov (United States)

    Goodin, Burel R; Quinn, Noel B; Kronfli, Tarek; King, Christopher D; Page, Gayle G; Haythornthwaite, Jennifer A; Edwards, Robert R; Stapleton, Laura M; McGuire, Lynanne

    2012-01-01

    Current evidence supports the efficacy of hypnosis for reducing the pain associated with experimental stimulation and various acute and chronic conditions; however, the mechanisms explaining how hypnosis exerts its effects remain less clear. The hypothalamic-pituitary-adrenal (HPA) axis and pro-inflammatory cytokines represent potential targets for investigation given their purported roles in the perpetuation of painful conditions; yet, no clinical trials have thus far examined the influence of hypnosis on these mechanisms. Healthy participants, highly susceptible to the effects of hypnosis, were randomized to either a hypnosis intervention or a no-intervention control. Using a cold pressor task, assessments of pain intensity and pain unpleasantness were collected prior to the intervention (Pre) and following the intervention (Post) along with pain-provoked changes in salivary cortisol and the soluble tumor necrosis factor-α receptor II (sTNFαRII). Compared with the no-intervention control, data analyses revealed that hypnosis significantly reduced pain intensity and pain unpleasantness. Hypnosis was not significantly associated with suppression of cortisol or sTNFαRII reactivity to acute pain from Pre to Post; however, the effect sizes for these associations were medium-sized. Overall, the findings from this randomized controlled pilot study support the importance of a future large-scale study on the effects of hypnosis for modulating pain-related changes of the HPA axis and pro-inflammatory cytokines. Wiley Periodicals, Inc.

  8. Trials of Improved Practices (TIPs to Enhance the Dietary and Iron-Folate Intake during Pregnancy- A Quasi Experimental Study among Rural Pregnant Women of Varanasi, India.

    Directory of Open Access Journals (Sweden)

    Siddharudha Shivalli

    Full Text Available Behavior Change Communications (BCC play a decisive role in modifying socio-cultural norms affecting the perception and nutritional practices during pregnancy.To examine the effectiveness of 'Trials of Improved Practices' (TIPs on dietary and iron-folate intake during pregnancy.Community based quasi experimental study with a control group.Four villages of Chiraigaon Community Development Block of Varanasi, India from May 2010 and recruited from August 2010. End line assessment, after 12 weeks of intervention, was completed in April 2011.Pregnant women in 13-28 weeks of gestation.TIPs was implemented in addition to ongoing essential obstetric care services in two villages through 3 home (assessment, negotiation and evaluation visits and only assessment and evaluation visits in the other two control villages. Interpersonal communication, endorsing the active participation of family members and home based reminder materials were the TIPs based strategies. The effect of TIPs was assessed by comparing key outcome variables at baseline and after 12 weeks of intervention.Hemoglobin%, anemia prevalence, weight gain, compliance for iron-folate supplementation and dietary intake of calorie, protein, calcium and iron.A total of 86 participants completed the study. At the end, mean hemoglobin levels were 11.5±1.24 g/dl and 10.37±1.38 g/dl in the TIPs and control groups, respectively. The prevalence of anemia reduced by half in TIPs group and increased by 2.4% in the control group. Weight gain (grams/week was significantly (p<0.01 higher in TIPs group (326.9±91.8 vs. 244.6±97.4. More than 85% of the PW in TIPs group were compliant for Iron-folate and only 38% were compliant among controls. The mean intake of protein increased by 1.78gm in intervention group and decreased by 1.81 gm in controls (p<0.05. More than two thirds of PW in TIPs group were taking one extra meal and only one third of controls were doing the same.TIPs found to be an effective

  9. 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

  10. [Between research and genocide. The Nuremberg physician trials 1946/47: Raphael Lemkins point of view on human experimentation and genocide].

    Science.gov (United States)

    Weindling, Paul

    2007-01-01

    While the significance of the new concept of genocide, as introduced by the Polish émigré jurist Raphael Lemkin, has been recognised, its importance for the Nuremberg Medical Trial has been overlooked. Lemkin commented extensively on the Trial, and his views are presented here. These comments help illuminate a neglected facet of the Trial, that of eugenics and racial extermination, taken at the time as amounting to genocide. Far from neglecting eugenics as some have suggested, the eugenic component of the Trial was extensive.

  11. The effect of a combination of gabapentin and donepezil in an experimental pain model in healthy volunteers: Results of a randomized controlled trial.

    Science.gov (United States)

    Boyle, Yvonne; Fernando, Disala; Kurz, Hazel; Miller, Sam R; Zucchetto, Mauro; Storey, James

    2014-12-01

    This double-blind, placebo-controlled, 3-period cross-over, 4-treatment option, incomplete block study (ClinicalTrials.gov number NCT01485185), with an adaptive design for sample size re-estimation, was designed to evaluate gabapentin plus donepezil in an established experimental model of electrical hyperalgesia. Thirty healthy male subjects aged 18-55 years were randomized to receive gabapentin 900 mg or gabapentin 900 mg+donepezil 5mg for 2 of the 3 treatment periods, with 50% of subjects randomized to receive placebo (negative control) and 50% to gabapentin 1800 mg (positive control) for the remaining period. Each treatment period was 14 days. Gabapentin or corresponding placebo was administered on Day 13 and the morning of Day 14. Donepezil or corresponding placebo was administered nocturnally from Day 1-13 and the morning of Day 14. Co-primary endpoints were the area of pinprick hyperalgesia (260 mN von Frey filament) and allodynia (stroking by cotton bud) evoked by electrical hyperalgesia on Day 14. Gabapentin 1800 mg (n=14) significantly reduced the area of allodynia vs placebo (n=14; -12.83 cm(2); 95% confidence interval [CI] -23.14 to -2.53; P=0.015) with supportive results for hyperalgesia (-14.04 cm(2); 95% CI -28.49-0.41; P=0.057), validating the electrical hyperalgesia model. Gabapentin+donepezil (n=30) significantly reduced the area of hyperalgesia vs gabapentin 900 mg (n=30; -11.73 cm(2); 95% CI -21.04 to -2.42; P=0.014), with supportive results for allodynia (-6.62 cm(2); 95% CI -13.29-0.04; P=0.052). The adverse event profile for gabapentin+donepezil was similar to the same dose of gabapentin. Data are supportive of further clinical investigation of a gabapentin-and-donepezil combination in patients with an inadequate response to gabapentin. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  12. Insecurity, distress and mental health: experimental and randomized controlled trials of a psychosocial intervention for youth affected by the Syrian crisis.

    Science.gov (United States)

    Panter-Brick, Catherine; Dajani, Rana; Eggerman, Mark; Hermosilla, Sabrina; Sancilio, Amelia; Ager, Alastair

    2017-10-02

    Strengthening the evidence base for humanitarian interventions that provide psychosocial support to war-affected youth is a key priority. We tested the impacts of an 8-week programme of structured activities informed by a profound stress attunement (PSA) framework (Advancing Adolescents), delivered in group-format to 12-18 year-olds in communities heavily affected by the Syrian crisis. We included both Syrian refugee and Jordanian youth. We followed an experimental design, comparing treatment youth and wait-list controls over two programme implementation cycles, randomizing to study arm in cycle 2 (ClinicalTrials.gov ID: NCT03012451). We measured insecurity, distress, mental health difficulties, prosocial behaviour and post-traumatic stress symptoms at three time-points: baseline (n = 817 youth; 55% Syrian, 43% female), postintervention (n = 463; 54% Syrian, 47% female), and follow-up (n = 212, 58% Syrian, 43% female). Regression models assessed: prospective intervention impacts, adjusting for baseline scores, trauma exposure, age, and gender; differential impacts across levels of trauma exposure and activity-based modality; and sustained recovery 1 year later. We analysed cycle-specific and cycle-pooled data for youth exclusively engaged in Advancing Adolescents and for the intent-to-treat sample. We found medium to small effect sizes for all psychosocial outcomes, namely Human Insecurity (β = -7.04 (95% CI: -10.90, -3.17), Cohen's d = -0.4), Human Distress (β = -5.78 (-9.02, -2.54), d = -0.3), and Perceived Stress (β = -1.92 (-3.05, -0.79), d = -0.3); and two secondary mental health outcomes (AYMH: β = -3.35 (-4.68, -2.02), d = -0.4; SDQ: β = -1.46 (-2.42, -0.50), d = -0.2). We found no programme impacts for prosocial behaviour or post-traumatic stress reactions. Beneficial impacts were stronger for youth with exposure to four trauma events or more. While symptoms alleviated for both intervention and control groups over time, there were sustained effects of

  13. Thermal conditions of rock slopes below unstable infrastructure in Alpine permafrost area: the cases of the Cosmiques hut and the Grands Montets cable-car station (Mont Blanc massif)

    Science.gov (United States)

    Duvillard, Pierre-Allain; Magnin, Florence; Mörtl, Christian; Ravanel, Ludovic; Deline, Philip

    2017-04-01

    Thermal state of steep permafrost-affected rock faces is crucial to assess the safety and reliability of mountain infrastructure as current permafrost degradation affects the rock slope stability. In the Mont-Blanc massif, 23 infrastructures are built on such a rock face with 13 of them that are characterized by a high risk of destabilization (Duvillard et al., 2015), including the upper station of the Grands Montets cable car (3325 m a.s.l.) as well as the Cosmiques hut (3613 m a.s.l.) on which we will focus. These two buildings have already been affected by different geomorphological processes. A rockfall event (600 m3) occurred for example on the SE face on the Arête inférieure des Cosmiques on the 21st of August 1998 (Ravanel et al., 2013) and the Grands Montets case shows a slow subsidence of the stairway over the last decade. In order to better assess the role of the permafrost in these processes and to gain insight on possible future geomorphic activity, we characterized the current permafrost conditions and simulated its changes up to the end of the 21st century using two complementary approaches: (i) the result of ERT (Electrical Resistivity Tomography) surveys carried out in October 2016 on the northern and southern faces right below the Cosmiques hut (at the level of the foundations) and at the Aiguilles des Grands Montets; (ii) the modeling of mean annual rock surface temperature for 2016 and at the end of the 21st century (Magnin et al., in rev.). Duvillard P.-A., Ravanel L., Deline P. (2015). Risk assessment of infrastructure destabilisation due to global warming in the high French Alps. Journal of Alpine Research, 103 (2). Magnin F., Josnin J.-Y., Ravanel L., Pergaud J., Pohl B., Deline P. (in rev.). Modelling rock wall permafrost degradation in the Mont Blanc massif from the LIA to the end of the 21st century. The Cryosphere Discuss., doi:10.5194/tc-2016-132. Ravanel L., Deline P., Lambiel C. and Vincent C. (2013). Instability of a high alpine

  14. From transplanting Schwann cells in experimental rat spinal cord injury to their transplantation into human injured spinal cord in clinical trials.

    Science.gov (United States)

    Bunge, Mary B; Monje, Paula V; Khan, Aisha; Wood, Patrick M

    2017-01-01

    Among the potential therapies designed to repair the injured spinal cord is cell transplantation, notably the use of autologous adult human Schwann cells (SCs). Here, we detail some of the critical research accomplished over the last four decades to establish a foundation that enables these cells to be tested in clinical trials. New culture systems allowed novel information to be gained about SCs, including discovering ways to stimulate their proliferation to acquire adequately large numbers for transplantation into the injured human spinal cord. Transplantation of rat SCs into rat models of spinal cord injury has demonstrated that SCs promote repair of injured spinal cord. Additional work required to gain approval from the Food and Drug Administration for the first SC trial in the Miami Project is disclosed. This trial and a second one now underway are described. © 2017 Elsevier B.V. All rights reserved.

  15. Understanding noninferiority trials

    Directory of Open Access Journals (Sweden)

    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.

  16. PRECISÃO EXPERIMENTAL E TAMANHO DA ÁREA DE EXPERIMENTOS DE CAMPO COM FRUTEIRAS E OUTRAS PLANTAS PERENES ARBÓREAS EM FUNÇÃO DA UNIDADE EXPERIMENTAL E DO NÚMERO DE REPETIÇÕES PRECISION AND AREA SIZE IN FIELD TRIALS WITH PERENNIAL PLANTS AND FRUITS TREES AS FUNCTION OF THE PLOT AND NUMBER OF REPLICATES

    Directory of Open Access Journals (Sweden)

    ADROALDO GUIMARÃES ROSSETTI

    2001-12-01

    Full Text Available Um problema dos experimentos de campo com plantas perenes e frutíferas arbóreas é o tamanho da área, devido ao porte das plantas que normalmente exigem largos espaçamentos. É muito freqüente, nesses experimentos, o uso de parcelas grandes, em detrimento do número de repetições, com a justificativa de diminuir a área experimental, a mão-de-obra e o conseqüente custo da pesquisa. Essa prática, contudo, traz prejuízos à precisão das estimativas dos parâmetros e à aplicação eficiente de testes estatísticos. Este trabalho foi realizado com o objetivo de mostrar que o aumento do número de repetições com o uso de parcelas pequenas aumenta a precisão dos experimentos, das estimativas do erro experimental e dos efeitos de tratamentos, favorece a detecção de diferenças significativas entre os tratamentos e contribui para diminuir a área experimental. Desenvolveu-se um procedimento que associa o tamanho da unidade experimental ao número de repetições, pela minimização da variância da média de cada tratamento, que permite o uso de maior número de repetições, para aumentar a precisão dos testes, obter maior uniformidade no experimento e melhorar a qualidade das pesquisas. Os resultados obtidos permitiram observar que o uso de parcelas pequenas favorece o aumento do número de repetições, permite obter melhores estimativas do erro experimental, dos efeitos de tratamentos e dos parâmetros, além de dar mais eficiência aos testes estatísticos a serem aplicados aos dados. Observou-se, também, diminuição substancial do número de plantas necessárias aos experimentos e do tamanho da área experimental.Area size is a matter of concern in field trials with perennial plants and fruits trees, as they usually require large spacings. Big plots and small number of replications are frequently used in these cases to justify the reduction in the experimental area, labor and consequently in the costs of the research. However

  17. Generating and predicting high quality action plans to facilitate physical activity and fruit and vegetable consumption: results from an experimental arm of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Dominique Alexandra Reinwand

    2016-04-01

    Full Text Available Abstract Background In order to improve the transition from an intention to a change in health behaviour, action planning is a frequently used behavioural change method. The quality of action plans in terms of instrumentality and specificity is important in terms of supporting a successful change in health behaviour. Until now, little has been known about the predictors of action plan generation and the predictors of high quality action plans and, therefore, the current study investigates these predictors. Method A randomised controlled trial was conducted to improve physical activity (PA and fruit and vegetable (FV consumption using a web-based computer tailored intervention. During the 8-week intervention period, participants in the intervention arm (n = 346 were guided (step-by-step to generate their own action plans to improve their health behaviours. Demographic characteristics, social cognitions, and health behaviour were assessed at baseline by means of self-reporting. Whether participants generated action plans was tracked by means of server registrations within two modules of the intervention. Results The action planning component of the intervention regarding physical activity and fruit and vegetable consumption was used by 40.9 and 20.7 % of the participants, respectively. We found that participants who were physically active at baseline were less likely to generate action plans concerning physical activity. With regards to generating fruit and vegetable action plans, participants with a high risk perception and a strong intention to eat fruit and vegetables on a daily basis made more use of the action planning component for this behaviour. Finally, the large majority of the action plans for physical activity (96.6 % and fruit and vegetable consumption (100 % were instrumental and about half of the action plans were found to be highly specific (PA = 69.6 %/FV = 59.7 %. The specificity of the action plans is associated

  18. High- and Low-Level Dissonance-Based Eating Disorder Prevention Programs with Young Women with Body Image Concerns: An Experimental Trial

    Science.gov (United States)

    McMillan, Whitney; Stice, Eric; Rohde, Paul

    2011-01-01

    Objective: As cognitive dissonance is theorized to contribute to the effects of dissonance-based eating disorder prevention programs, we evaluated a high-dissonance version of this program against a low-dissonance version and a wait-list control condition to provide an experimental test of the mechanism of intervention effects. Method: Female…

  19. Influence of Erythropoietin on Cognitive Performance during Experimental Hypoglycemia in Patients with Type 1 Diabetes Mellitus: A Randomized Cross-Over Trial

    Science.gov (United States)

    Kristensen, Peter Lommer; Pedersen-Bjergaard, Ulrik; Kjær, Troels Wesenberg; Olsen, Niels Vidiendal; Dela, Flemming; Holst, Jens Juul; Faber, Jens; Tarnow, Lise; Thorsteinsson, Birger

    2013-01-01

    Introduction The incidence of severe hypoglycemia in type 1 diabetes has not decreased over the past decades. New treatment modalities minimizing the risk of hypoglycemic episodes and attenuating hypoglycemic cognitive dysfunction are needed. We studied if treatment with the neuroprotective hormone erythropoietin (EPO) enhances cognitive function during hypoglycemia. Materials and Methods Eleven patients with type 1 diabetes, hypoglycemia unawareness and recurrent severe hypoglycemia completed the study. In a double-blind, randomized, balanced, cross-over study using clamped hypoglycemia they were treated with 40,000 IU of EPO or placebo administered intravenously six days before the two experiments. Cognitive function (primary endpoint), hypoglycemic symptoms, and counter-regulatory hormonal response were recorded. Results Compared with placebo, EPO treatment was associated with a significant reduction in errors in the most complex reaction time task (−4.7 (−8.1 to −1.3), p = 0.01) and a less reaction time prolongation (−66 (−117 to −16) msec, p = 0.02). EPO treatment did not change performance in other measures of cognition. Hypoglycemic symptoms, EEG-changes, and counter-regulatory hormone concentrations did not differ between EPO and placebo treatment. Conclusion In patients with type 1 diabetes and hypoglycemia unawareness, treatment with EPO is associated with a beneficial effect on cognitive function in a complex reaction time task assessing sustained attention/working memory. Hypoglycemic symptoms and hormonal responses were not changed by EPO treatment. Trial Registration ClinicalTrials.gov NCT00615368 PMID:23577069

  20. Influence of erythropoietin on cognitive performance during experimental hypoglycemia in patients with type 1 diabetes mellitus: a randomized cross-over trial.

    Directory of Open Access Journals (Sweden)

    Peter Lommer Kristensen

    Full Text Available The incidence of severe hypoglycemia in type 1 diabetes has not decreased over the past decades. New treatment modalities minimizing the risk of hypoglycemic episodes and attenuating hypoglycemic cognitive dysfunction are needed. We studied if treatment with the neuroprotective hormone erythropoietin (EPO enhances cognitive function during hypoglycemia.Eleven patients with type 1 diabetes, hypoglycemia unawareness and recurrent severe hypoglycemia completed the study. In a double-blind, randomized, balanced, cross-over study using clamped hypoglycemia they were treated with 40,000 IU of EPO or placebo administered intravenously six days before the two experiments. Cognitive function (primary endpoint, hypoglycemic symptoms, and counter-regulatory hormonal response were recorded.Compared with placebo, EPO treatment was associated with a significant reduction in errors in the most complex reaction time task (-4.7 (-8.1 to -1.3, p = 0.01 and a less reaction time prolongation (-66 (-117 to -16 msec, p = 0.02. EPO treatment did not change performance in other measures of cognition. Hypoglycemic symptoms, EEG-changes, and counter-regulatory hormone concentrations did not differ between EPO and placebo treatment.In patients with type 1 diabetes and hypoglycemia unawareness, treatment with EPO is associated with a beneficial effect on cognitive function in a complex reaction time task assessing sustained attention/working memory. Hypoglycemic symptoms and hormonal responses were not changed by EPO treatment.ClinicalTrials.gov NCT00615368.

  1. Influence of erythropoietin on cognitive performance during experimental hypoglycemia in patients with type 1 diabetes mellitus: a randomized cross-over trial.

    Science.gov (United States)

    Kristensen, Peter Lommer; Pedersen-Bjergaard, Ulrik; Kjær, Troels Wesenberg; Olsen, Niels Vidiendal; Dela, Flemming; Holst, Jens Juul; Faber, Jens; Tarnow, Lise; Thorsteinsson, Birger

    2013-01-01

    The incidence of severe hypoglycemia in type 1 diabetes has not decreased over the past decades. New treatment modalities minimizing the risk of hypoglycemic episodes and attenuating hypoglycemic cognitive dysfunction are needed. We studied if treatment with the neuroprotective hormone erythropoietin (EPO) enhances cognitive function during hypoglycemia. Eleven patients with type 1 diabetes, hypoglycemia unawareness and recurrent severe hypoglycemia completed the study. In a double-blind, randomized, balanced, cross-over study using clamped hypoglycemia they were treated with 40,000 IU of EPO or placebo administered intravenously six days before the two experiments. Cognitive function (primary endpoint), hypoglycemic symptoms, and counter-regulatory hormonal response were recorded. Compared with placebo, EPO treatment was associated with a significant reduction in errors in the most complex reaction time task (-4.7 (-8.1 to -1.3), p = 0.01) and a less reaction time prolongation (-66 (-117 to -16) msec, p = 0.02). EPO treatment did not change performance in other measures of cognition. Hypoglycemic symptoms, EEG-changes, and counter-regulatory hormone concentrations did not differ between EPO and placebo treatment. In patients with type 1 diabetes and hypoglycemia unawareness, treatment with EPO is associated with a beneficial effect on cognitive function in a complex reaction time task assessing sustained attention/working memory. Hypoglycemic symptoms and hormonal responses were not changed by EPO treatment. ClinicalTrials.gov NCT00615368.

  2. 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).

  3. 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).

  4. Hut collectieve aspect in de Deense woningbouw

    DEFF Research Database (Denmark)

    Welling, Helen

    2003-01-01

    'The collective aspect in danish housing development'. Artiklen gennemgår udviklingen af en række kollektive funktioner relateret til boligen. Eksemplerne er taget fra Boligselskaberne i perioden 1920-1970.......'The collective aspect in danish housing development'. Artiklen gennemgår udviklingen af en række kollektive funktioner relateret til boligen. Eksemplerne er taget fra Boligselskaberne i perioden 1920-1970....

  5. 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. "

  6. THE HUT ME SKIN AS TRANSITIONAL SPACE

    Directory of Open Access Journals (Sweden)

    Brigitte Rota

    2011-12-01

    Full Text Available This was a keynote address delivered at the International Integrative Psychotherapy Association Conference in Vichy, France. Focus was on individual sessions and art therapy with play as a way to create a space for creation and emerging of Self.

  7. Effect of Wheelchair Running on Recovery of Blood Lactate and Physical Performance after High-Intensity Intermittent Exercise – An Experimental Trial

    Directory of Open Access Journals (Sweden)

    Karthikeyan G

    2012-04-01

    Full Text Available Background and Purpose: Repetitive sprint sport players perform high intensity exercise only for a small percentage of a total game and such periods are often instrumental in determining the eventual outcome. Recovery is a key factor for performance, and constant lack of recovery or insufficient recovery turns into overtraining which is detrimental in achieving peak performance. The purpose was to find out the effect of wheelchair running on the physical performance recovery after high-intensity intermittent exercise. Method: Ten sportsmen having the age range from 20 to 29, VO2max Ranges from 60.51 to 64.29 were randomly divided into experimental and control groups. After filling pre-participation questionnaire and 30-min of supine rest, Blood lactate and the field tests for the measurement of static balance, power, speed and agility were applied. The subjects were made to run in the treadmill and to increase the intensity to reach the Target Heart Rate (THR. After 1-min the subjects were given rest for 15-s and after that they started exercise again and thus the subjects completed several bouts of such exercises until exhaustion followed by either Passive rest or wheelchair running for the duration of 10 minutes. Parameters were measures after completed the exercise bout and after the recovery. Results: After the recovery in experimental group significant improvement found only in blood lactate (p<0.01 and no significant changes found in other parameters while in control group no significant changes found in all parameters. There was no significant difference found in all the parameters including blood lactate between the groups. Conclusion: Both wheelchair running and passive recovery are same in the efficiency of blood lactate removal and restoration of physical performance following intense intermittent exercise.

  8. 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)

    Fongnikin, Augustin; Rowland, Mark; N’Guessan, Raphael

    2017-01-01

    Introduction 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. Methods 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. Results 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. Conclusion IRS campaigns with the mixture of clothianidin plus

  9. Experimental trials on the feasibility of offshore seed production of the mussel Mytilus edulis in the German Bight: installation, technical requirements and environmental conditions

    Science.gov (United States)

    Buck, Bela Hieronymus

    2007-06-01

    This study summarizes the activities and findings during a 2 year investigation on the grow-out of blue mussels ( Mytilus edulis) and the technical requirements to withstand harsh weather conditions at an offshore location. The experimental sites were two different test areas, each 5 ha in size, 12-15 m in depth, in the vicinity of the offshore lighthouse “Roter Sand” located 15-17 nautical miles northwest of the city of Bremerhaven (Germany). Two versions of submerged longline systems were deployed: a conventional polypropylene longline in 2002 as well as a steel hawser longline in 2003, both featuring different versions of buoyancy modes. The spat collectors and grow-out ropes were suspended perpendicular from the horizontal longline for several months beginning in March of each respective year. The test sites were visited and sampled on a monthly basis using research vessels. Larval abundances in the surrounding water column reached numbers of up to 1,467 individuals m-3. Post-larval settlement success varied through the entire experimental period, ranging from 29 to 796 individuals of spat per meter of collector. Settled mussels reached a shell length of up to 28 mm 6 months after settlement. Based on the growth rates observed for the seed, it is projected that mussels would reach market size (50 mm) in 12-15 months post settlement, and at the observed densities, each meter of collector rope could yield 10.9 kg of harvestable mussels. The polypropylene line resisted storm conditions with wind waves of up to 6.4 m and current velocities of 1.52 m s-1 and was retrieved in autumn of 2002. In contrast, the steel hawser-based line did not withstand the harsh weather conditions. The steel-based line consisted of six twisted strands that were untwisted by the strong currents and turbulences and consequently the individual strands were torn. Additionally, the line was accidentally cut by a yacht in July 2003. The biological study revealed that the tested location

  10. [Crosslinking sodium hyaluronate gel with different ratio of molecular weight for subcutaneous injection: animal experimental study and clinical trials subcutaneous injection].

    Science.gov (United States)

    Ran, Weizhi; Wang, Xiaoli; Hu, Yuefei; Gao, Songying; Yang, Yahong; Sun, Jian; Sun, Shuming; Liu, Zhongmei; Wang, Jiangling

    2015-05-01

    To investigate the biocompatibility and degradation rate of crosslinking sodium hyaluronate gel with different ratio of molecular weight, so as to choose the effective, safe and totally degraded hyaluronate gel for aesthetic injection. (1) Compound colloid was formed by cross-linking the divinyl sulphone and sodium hyaluronate with different molecular weight (4 x 10(5), 8 x 10(5), 10 x 10(5), 12 x 10(5)). (2) Healthy level KM mice was randomly divided into two groups to receive hyaluronic acid gel or liquid injection. Each group was subdivided into three subgroup to receive hyaluronic acid with different molecular weight. The biocompatibility and degradation rate, of hyaluronate were observed at 7, 90, 180 days after injection. At the same time, different molecular weight of sodium hyaluronate gel is sealed or exposed respectively under the low temperature preservation to observe its natural degradation rate. (3) The most stable colloid was selected as aesthetic injector for volunteers to observe the aesthetic effect. The sodium hyaluronate gel with molecular of 4 x 10(5) was completely degraded 90 days later. The sodium hyaluronate gel with molecular of 8 x 10(5) was completely degraded 180 days later. The sodium hyaluronate gel with molecular of 10 x 10(5) was degraded to 90.0% after 180 days. The sodium hyaluronate liquid can be degraded completely within 7 days. The colloid could be kept for at least 12 months when sealed under low temperature, but was totally degraded when exposed for I d. Sodium hyaluronate gel with molecular 10 x 10(5) was confirmed to be kept for at least 6 months in animal experiment and clinical trials. Under the same condition of material ratio, the higher the molecular weight is, the lower the degradation rate is. But the liquidity of gel is not good for injection when molecular weight is too large. It suggests that Sodium hyaluronate gel with molecular 10 x 10(5) maybe the best choice in cosmetic injections.

  11. Investigating the clinical feasibility of an adapted early mobility readiness protocol for critical ill patients: A non-randomised experimental pilot trial.

    Science.gov (United States)

    Conradie, Elmarie; Fourie, Catharina E; Hanekom, Susan D

    2017-10-01

    Uncertainty exists whether a therapeutic early mobility position will affect the outcome of a critically ill patient. To evaluate the feasibility of an existing protocol to identify patients who would tolerate this position. A non-randomised experimental pilot trail was performed. Twice weekly, all patients nursed in surgical and respiratory units were screened with the protocol. Haemodynamic parameters, mean arterial pressure and central venous oxygen saturation of included patients were tested in the baseline position followed by the testing position at 0, 3 and 10minutes. We screened 138 patients. Eleven patients passed the protocol, male/female (9/2) with a median (range) age of 47 (20-67) years. Placement from the 10minutes baseline position to the 0min testing position resulted in a mean difference of the mean arterial pressure of 2.03 (95% Confidence interval -1.12 to 5.18), and the mean difference of central venous oxygen saturation was 0.79 (95% Confidence interval -3.15 to 4.74). One adverse event was noted. The protocol provides healthcare professionals with an interim tool to identify patients who would tolerate a therapeutic upright position. While the results question the clinical feasibility of protocol. The effect of incorporating a therapeutic early mobility position into standard nursing care, on patient outcome can now be investigated. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Impact of applied progressive deep muscle relaxation training on the health related quality of life among prostate cancer patients--a quasi experimental trial.

    Science.gov (United States)

    Isa, Mohamad-Rodi; Moy, Foong Ming; Razack, Azad-Hassan Abdul; Zainuddin, Zulkifli Md; Zainal, Nor-Zuraida

    2013-01-01

    To determine the impact of applied progressive muscle relaxation training on health related quality of life among prostate cancer patients. A quasi-experimental study was conducted at the University Malaya Medical Centre (UMMC) and Universiti Kebangsaan Malaysia Medical Centre (UKMMC) over six months. Patients from UMMC received the intervention and patients from UKMMC as a comparison group. The general health related quality of life was measured using Short Form-36 (SF-36). A total of 77 patients from the intervention group and 78 patients from the comparison group participated in the study. At the end of the study, only 90.9% in intervention group and 87.2% in comparison group completed the study. There were significant differences between intervention and comparison groups for mental component summary (MCS) (p=0.032) and overall health related quality of life (p=0.042) scores. However, there was no significant difference between groups for physical component summary (PCS) (p=0.965). The improvement in MCS and overall QOL showed the potential of APMRT in the management of prostate cancer patients. Future studies should be carried out over a longer duration to provide stronger evidence for the introduction of relaxation therapy among prostate cancer patients as a coping strategy to improve their QOL. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. Therapeutic trial in experimental tegumentary leishmaniasis caused by Leishmania (Leishmania amazonensis. A comparative study between mefloquine and aminosidine Ensaio terapêutico na leishmaniose tegumentar experimental causada por Leishmania (Leishmania amazonensis. Um estudo comparativo entre mefloquina e aminosidine

    Directory of Open Access Journals (Sweden)

    Letícia Oba Galvão

    2000-08-01

    Full Text Available One hundred and eighty-two male inbred C57/BL/6 mice were infected with 3 x 106 Leishmania (Leishmania amazonensis promastigotes of the MHOM/BR/PH8 strain by means of a subcutaneous injection in the right ear. The animals were separated in three groups: 1 oral mefloquine hydrochloride treatment (16mg/kg/day/10 days, 2 intramuscular aminosidine (Paromomycin® treatment (20mg/kg/20 days and 3 control. Twenty six mice of each treated group were sacrificed, one at the end of treatment (nine weeks after inoculation, and one six weeks later (fifteen weeks after inoculation. Control Group animals were sacrificed at weeks six, nine and fifteen after inoculation. There was no significant difference between Group 1 (mefloquine and Group 3 (control subjects. Group 2 animals (aminosidine presented the smallest differences of all, both at the end of the treatment and six weeks later. The histopato-logical parameters have shown the following findings: a there was no significant difference between the mefloquine treated group and the control group; the group treated with aminosidine showed fewer of vacuolated macrophages than the control group, at week 9 (end of treatment. b both at the end of treatment and six weeks later, evaluation of tissue necrosis and tissue fibrosis revealed no differences between the treated groups. It was found that six weeks after the end of treatment, mice in the control group presented significantly more severe degrees of fibrosis than mice in the other groups. It can be concluded that mefloquine showed limited therapeutic effect in this experimental model, whereas aminosidine had a significant effect. Nevertheless, neither of them resulted in cure of the lesions.Foram utilizados 182 camundongos machos, isogênicos, da linhagem C57BL/6 inoculados na orelha direita com 3,0 x 10(6 formas promastigotas da cepa MHOM/BR/PH8 de Leishmania (Leishmania amazonensis. Os animais foram separados em três grupos: 1 52 animais tratados com

  14. Development and trial manufacturing of 1/2-scale partial mock-up of blanket box structure for fusion experimental reactor

    Science.gov (United States)

    Hashimoto, Toshiyuki; Takatsu, Hideyuki; Sato, Satoshi

    1994-07-01

    Conceptual design of breeding blanket has been discussed during the CDA (Conceptual Design Activities) of ITER (International Thermonuclear Experimental Reactor). Structural concept of breeding blanket is based on box structure integrated with first wall and shield, which consists of three coolant manifolds for first wall, breeding and shield regions. The first wall must have cooling channels to remove surface heat flux and nuclear heating. The box structure includes plates to form the manifolds and stiffening ribs to withstand enormous electromagnetic load, coolant pressure and blanket internal (purge gas) pressure. A 1/2-scale partial model of the blanket box structure for the outboard side module near midplane is manufactured to estimate the fabrication technology, i.e. diffusion bonding by HIP (Hot Isostatic Pressing) and EBW (Electron Beam Welding) procedure. Fabrication accuracy is a key issue to manufacture first wall panel because bending deformation during HIP may not be small for a large size structure. Data on bending deformation during HIP was obtained by preliminary manufacturing of HIP elements. For the shield structure, it is necessary to reduce the welding strain and residual stress of the weldment to establish the fabrication procedure. Optimal shape of the parts forming the manifolds, welding locations and welding sequence have been investigated. In addition, preliminary EBW tests have been performed in order to select the EBW conditions, and fundamental data on built-up shield have been obtained. Especially, welding deformation by joining the first wall panel to the shield has been measured, and total deformation to build-up shield by EBW has been found to be smaller than 2 mm. Consequently, the feasibility of fabrication technologies has been successfully demonstrated for a 1m-scaled box structure including the first wall with cooling channels by means of HIP, EBW and TIG (Tungsten Inert Gas arc)-welding.

  15. Simplifying the WHO 'how to hand rub' technique: three steps are as effective as six-results from an experimental randomized crossover trial.

    Science.gov (United States)

    Tschudin-Sutter, S; Rotter, M L; Frei, R; Nogarth, D; Häusermann, P; Stranden, A; Pittet, D; Widmer, A F

    2017-06-01

    The World Health Organization (WHO) issued guidelines on hand hygiene recommending a six-step 'how to hand rub' technique for applying alcohol-based hand rub. However, adherence to all six steps is poor. We assessed a simplified three-step technique and compared it to the conventional WHO six-step technique in terms of bacterial count reduction on healthcare workers' hands. Thirty-two participants were randomly assigned to clean their hands following the six-step 'how to hand rub' technique (WHO reference group) or a simplified three-step technique (intervention group). Assignments were reversed after 1 day. The degree of bacterial killing was assessed following the European norm for testing hand hygiene products. Hands were contaminated with Escherichia coli, and the mean logarithmic reduction in bacterial counts was compared between both techniques. Bacterial density before hand hygiene performance did not differ between the WHO reference group (median 6.37 log10 CFU, interquartile range (IQR) 6.19-6.54) and the intervention group (median 6.34 log10 CFU, IQR 6.17-6.60, p 0.513). After hand hygiene, the logarithmic reduction factor was higher in the intervention group (median 4.45, IQR 4.04-5.15) compared to the WHO reference group (median 3.91, IQR 3.69-4.62, p 0.021). The WHO six-step 'how to hand rub' technique can be simplified to a 3-step procedure based on the reduction of bacterial counts on healthcare workers' hands achieved under experimental conditions. The proposed technique is easier to perform and could improve adherence to the execution of hand hygiene action. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  16. Qualitative suggestions about chemical weed control of poplar in the nursery and possible improvement on the basis of experimental trials over fifteen years

    Directory of Open Access Journals (Sweden)

    Gennaro M

    2009-06-01

    Full Text Available In this work the results of over fifteen years of experimentation are summarized, concerning the possibility of use of herbicides included in several chemical classes and with various mechanisms of action on poplar clones of different species, European and North American. The active ingredients were tested mainly singly or in commercial mixtures as well, applied before emergence (interpreted here as sprout of poplar cuttings not yet occurred and before weed infestation or after emergence (interpreted here as cuttings with sprouts 20-25 cm long and after weed colonisation. Almost 50% of the 43 tested formulations has proved to be unserviceable in poplar nursery because of the hard damage induced on plantlets, i.e. dicotyledonicides and those with a wide action range, especially applied after emergence. It was the case of acetolactate synthase inhibitors and synthetic auxins. About 25% of formulations has proved to be utilizable with limited risks and 20% without risk. After emergence, the lowest damage was caused by graminicide compounds included in the class of acetyl-CoA carboxylase inhibitors (e.g. diclofop-methyl, cycloxydim; before emergence, very good applicative opportunities were showed by microtubule assembly inhibitors, especially propyzamide, and the cellulose synthesis inhibitor isoxaben. Among the herbicides utilizable with some risk after emergence, the photosynthesis inhibitors pyridate and phenmedipham (singly or in mixture were interesting since they are the only ones that allow the control of broad-leaved weeds in the presence of herbaceous poplar shoots. Before emergence, flufenacet and isoxaflutole were remarkable as well, the latter being active versus hardly limited weeds. In summary, besides the two aforesaid compounds, the graminicide cycloxydim and - more cautiously - clodinafop and propaquizafop may be hopefully introduced in poplar nurseries after emergence, in association with the wide action range mixture of

  17. Clinical Trials

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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 ...

  18. 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 ...

  19. 'I've Changed My Mind', Mindfulness-Based Childbirth and Parenting (MBCP) for pregnant women with a high level of fear of childbirth and their partners: study protocol of the quasi-experimental controlled trial.

    Science.gov (United States)

    Veringa, Irena K; de Bruin, Esther I; Bardacke, Nancy; Duncan, Larissa G; van Steensel, Francisca J A; Dirksen, Carmen D; Bögels, Susan M

    2016-11-07

    Approximately 25 % of pregnant women suffer from a high level of Fear of Childbirth (FoC), as assessed by the Wijma Delivery Expectancy Questionnaire (W-DEQ-A, score ≥66). FoC negatively affects pregnant women's mental health and adaptation to the perinatal period. Mindfulness-Based Childbirth and Parenting (MBCP) seems to be potentially effective in decreasing pregnancy-related anxiety and stress. We propose a theoretical model of Avoidance and Participation in Pregnancy, Birth and the Postpartum Period in order to explore FoC and to evaluate the underlying mechanisms of change of MBCP. The 'I've Changed My Mind' study is a quasi-experimental controlled trial among 128 pregnant women (week 16-26) with a high level of FoC, and their partners. Women will be allocated to MBCP (intervention group) or to Fear of Childbirth Consultation (FoCC; comparison group). Primary outcomes are FoC, labour pain, and willingness to accept obstetrical interventions. Secondary outcomes are anxiety, depression, general stress, parental stress, quality of life, sleep quality, fatigue, satisfaction with childbirth, birth outcome, breastfeeding self-efficacy and cost-effectiveness. The total study duration for women is six months with four assessment waves: pre- and post-intervention, following the birth and closing the maternity leave period. Given the high prevalence and severe negative impact of FoC this study can be of major importance if statistically and clinically meaningful benefits are found. Among the strengths of this study are the clinical-based experimental design, the extensive cognitive-emotional and behavioural measurements in pregnant women and their partners during the entire perinatal period, and the representativeness of study sample as well as generalizability of the study's results. The complex and innovative measurements of FoC in this study are an important strength in clinical research on FoC not only in pregnant women but also in their partners. Dutch Trial

  20. Analysing the effect of stand density and site conditions on structure and growth of oak species using Nelder trials along an environmental gradient: experimental design, evaluation methods, and results

    Directory of Open Access Journals (Sweden)

    Enno Uhl

    2015-05-01

    Full Text Available Background Most current approaches in forest science and practice require information about structure and growth of individual trees rather than - or in addition to - sum and mean values of growth and yield at forest stand level as provided by classic experimental designs. By inventing the wheel design, Nelder provided the possibility to turn to the individual tree as basic information unit. Such trials provide valuable insights into the dependency of growth on stand density at particular sites. Methods Here, we present an extension of the original design and evaluation by Nelder. (i We established Nelder wheels along an environmental gradient through Europe in atlantic climate in Belgium and Germany, Mediterranean climate in Italy, continental climate in Hungary as well as on high land climate in Mexico. Such disjunct Nelder wheels along an environmental gradient can be regarded and analysed as a two-factor design with the factors of site condition and stand density. (ii We present an advanced statistical approach to evaluate density dependent growth dynamics of trees planted in form of the Nelder design, which considers spatio-temporal autocorrelation. (iii We prove the usefulness of the methods in improving ecological theory concerning density related productivity, trade-offs between facilitation and competition, and allometric relations between size variables. Results First evaluations based on remeasured Nelder wheels in oak (Quercus roburL. show a size growth differentiation during the first observation period. In particular, height growth is accelerated under higher competition indicating facilitation effects. We detect furthermore a high variability in allometric relations. Conclusions The proposed design, methods, and results are discussed regarding their impact on forest practice, model building, and ecological theory. We conclude that the extended Nelder approach is highly efficient in providing currently lacking individual tree level

  1. Clinical Trials

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    Full Text Available ... help produce reliable study results. Clinical trials are one of the final stages of a long and ... trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of lowering ...

  2. Clinical Trials

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    Full Text Available ... they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. The NIH may partner ... the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing ...

  3. Clinical Trials

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    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  4. Clinical Trials

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    Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  5. Clinical Trials

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    Full Text Available ... are research studies that explore whether a medical strategy, treatment, or device is safe and effective for ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  6. Clinical Trials

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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 ( ...

  7. Clinical Trials

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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 ...

  8. Clinical Trials

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    Full Text Available ... and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

  9. Clinical Trials

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    Full Text Available ... research—that is, who is eligible. Each trial must include only people who fit the patient traits ... to take part in the study. Each trial must include only people who fit the patient traits ...

  10. Clinical Trials

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    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ... lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...

  11. Clinical Trials

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    Full Text Available ... also requires DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs for some earlier phase trials that involve high-risk procedures (such as gene therapy) or ...

  12. 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, ... care providers might be part of your treatment team. They will monitor your health closely. You may ...

  13. Lung-protective ventilation initiated in the emergency department (LOV-ED): a study protocol for a quasi-experimental, before-after trial aimed at reducing pulmonary complications.

    Science.gov (United States)

    Fuller, Brian M; Ferguson, Ian; Mohr, Nicholas M; Stephens, Robert J; Briscoe, Cristopher C; Kolomiets, Angelina A; Hotchkiss, Richard S; Kollef, Marin H

    2016-04-11

    In critically ill patients, acute respiratory distress syndrome (ARDS) and ventilator-associated conditions (VACs) are associated with increased mortality, survivor morbidity and healthcare resource utilisation. Studies conclusively demonstrate that initial ventilator settings in patients with ARDS, and at risk for it, impact outcome. No studies have been conducted in the emergency department (ED) to determine if lung-protective ventilation in patients at risk for ARDS can reduce its incidence. Since the ED is the entry point to the intensive care unit for hundreds of thousands of mechanically ventilated patients annually in the USA, this represents a knowledge gap in this arena. A lung-protective ventilation strategy was instituted in our ED in 2014. It aims to address the parameters in need of quality improvement, as demonstrated by our previous research: (1) prevention of volutrauma; (2) appropriate positive end-expiratory pressure setting; (3) prevention of hyperoxia; and (4) aspiration precautions. The lung-protective ventilation initiated in the emergency department (LOV-ED) trial is a single-centre, quasi-experimental before-after study testing the hypothesis that lung-protective ventilation, initiated in the ED, is associated with reduced pulmonary complications. An intervention cohort of 513 mechanically ventilated adult ED patients will be compared with over 1000 preintervention control patients. The primary outcome is a composite outcome of pulmonary complications after admission (ARDS and VACs). Multivariable logistic regression with propensity score adjustment will test the hypothesis that ED lung-protective ventilation decreases the incidence of pulmonary complications. Approval of the study was obtained prior to data collection on the first patient. As the study is a before-after observational study, examining the effect of treatment changes over time, it is being conducted with waiver of informed consent. This work will be disseminated by

  14. Using the Intervention Mapping protocol to develop a family-based intervention for improving lifestyle habits among overweight and obese children: study protocol for a quasi-experimental trial

    Directory of Open Access Journals (Sweden)

    Tonje Holte Stea

    2016-10-01

    Full Text Available Abstract Background In light of the high prevalence of childhood overweight and obesity, there is a need of developing effective prevention programs to address the rising prevalence and the concomitant health consequences. The main aim of the present study is to systematically develop and implement a tailored family-based intervention for improving lifestyle habits among overweight and obese children, aged 6–10 years old, enhancing parental self-efficacy, family engagement and parent-child interaction. A subsidiary aim of the intervention study is to reduce the prevalence of overweight and obesity among those participating in the intervention study. Methods/design The Intervention Mapping protocol was used to develop a tailored family-based intervention for improving lifestyle habits among overweight and obese children. In order to gather information on local opportunities and barriers, interviews with key stakeholders and a 1-year pilot study was conducted. The main study has used a quasi-experimental controlled design. Locally based Healthy Life Centers and Public Health Clinics are responsible for recruiting families and conducting the intervention. The effect of the study will be measured both at completion of the 6 months intervention study and 6 and 18 months after the intervention period. An ecological approach was used as a basis for developing the intervention. The behavioral models and educational strategies include individual family counselling meetings, workshops focusing on regulation of family life, nutrition courses, and physical activity groups providing tailored information and practical learning sessions. Parents will be educated on how to use these strategies at home, to further support their children in improving their behaviors. Discussion A systematic and evidence-based approach was used for development of this family-based intervention study targeting overweight and obese children, 6–10 years old. This program, if

  15. Utilização do método de Papadakis na melhoria da qualidade experimental de ensaios com soja Use of the Papadakis method to improve soybean trial quality

    Directory of Open Access Journals (Sweden)

    Lindolfo Storck

    2008-05-01

    Full Text Available O trabalho teve como objetivo verificar as modificações na análise estatística, em relação ao atendimento aos pressupostos do modelo matemático e aos diferentes indicadores de precisão, que podem ser atribuídas à aplicação do método de Papadakis, na análise dos ensaios de competição de genótipos de soja. Foram usados os resultados da produção de grãos de soja de 226 ensaios de competição de genótipos, executados no delineamento de blocos completos ao acaso. Em cada ensaio, foram realizados: a verificação dos pressupostos, a análise da variância, os testes de hipóteses e outras estatísticas para identificação da precisão. Para verificar os ganhos em precisão, os mesmos dados foram analisados pelo método de Papadakis. Os pressupostos não foram violados em nenhum dos dois métodos de análise. A média do índice de diferenciação de Fasoulas aumentou de 5 para 12,43, em blocos homogêneos, e para 13,85, em blocos heterogêneos. O coeficiente de determinação, adequado para a classificação de precisão de experimentos, foi aproximadamente 10% superior com o uso do método de Papadakis, independentemente da eficiência do uso de blocos. A eficiência do método de Papadakis independe da eficiência do uso dos blocos e permite melhorias nos indicadores de precisão experimental.The objective of this work was to verify the modifications in statistical analysis regarding the assumption fulfillment and the different precision indicators which can be attributed to the application of the Papadakis method, in the analysis of soybean grain yield experiments. The results of soybean yield of 226 trials of genotype competition, performed in a design of complete randomized blocks, were used. For each experiment, the assumptions were checked for: the variance analyses, hypothesis tests and other analysis to identify its precision. In order to verify the profit in precision, the same data were analyzed using the Papadakis

  16. Clinical Trials

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    Full Text Available ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  17. Clinical Trials

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    Full Text Available ... The results from other clinical 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 was already in common ...

  18. Clinical Trials

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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 ...

  19. Redesigning TRACER trial after TRITON.

    Science.gov (United States)

    Serebruany, Victor L

    2015-10-15

    Designing of smart clinical trials is critical for regulatory approval and future drug utilization. Importantly, trial design should be reconsidered if the interim analyses suggest unexpected harm, or conflicting results were yielded from the other trials within the same therapeutic area. With regard to antiplatelet agents, the perfect example is redesigning of the ongoing PRoFESS trial by eliminating aspirin from clopidogrel arm after the earlier MATCH trial results became available. The goal was to aseess the unchanged TRACER trial design in light of the evidence yielded from the earlier completed TRITON trial. TRACER was designed as a triple versus dual antiplatelet trial in NSTEMI patients with no previous long-term outcome data supporting such aggressive strategy. TRITON data represented dual versus dual antiplatelet therapy, and became available before TRACER enrollment starts revealing prasugrel front-loaded early vascular benefit predominantly in STEMI patients with the growing over time bleeding and cancer risks. Moreover, large prasugrel NSTEMI TRITON cohort exhibited trend towards excess mortality in experimental arm warning against aggressive TRACER design. The long-term TRITON results in general, and especially in the NSTEMI patients challenge unchanged TRACER trial design. Applying dual, rather than triple antiplatelet therapy protocol modification should be considered in TRACER to minimize bleeding, cancer, and non-cardiovascular death risks. Copyright © 2015. Published by Elsevier Ireland Ltd.

  20. Experimental philosophy.

    Science.gov (United States)

    Knobe, Joshua; Buckwalter, Wesley; Nichols, Shaun; Robbins, Philip; Sarkissian, Hagop; Sommers, Tamler

    2012-01-01

    Experimental philosophy is a new interdisciplinary field that uses methods normally associated with psychology to investigate questions normally associated with philosophy. The present review focuses on research in experimental philosophy on four central questions. First, why is it that people's moral judgments appear to influence their intuitions about seemingly nonmoral questions? Second, do people think that moral questions have objective answers, or do they see morality as fundamentally relative? Third, do people believe in free will, and do they see free will as compatible with determinism? Fourth, how do people determine whether an entity is conscious?

  1. Clinical Trials

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    Full Text Available ... a laboratory (lab), where scientists first develop and test new ideas. If an approach seems promising, the ... Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study ...

  2. Clinical Trials

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    Full Text Available ... review data from a clinical trial for safety problems or differences in results among different groups. The DSMB also reviews research results from other relevant studies. These results may ...

  3. Clinical Trials

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    Full Text Available ... harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. ... Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance of ...

  4. Clinical Trials

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    Full Text Available ... participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional guidance on participating ...

  5. Clinical Trials

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    Full Text Available ... get special protection as research subjects. Almost always, parents must give legal consent for their child to ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. ...

  6. Clinical Trials

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    Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...

  7. Clinical Trials

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    Full Text Available ... scale phase III trials begin, the FDA provides input on how these studies should be done. Patient ... of stakeholders and advisory groups, NHLBI has received input and has established a multi-pronged approach to ...

  8. Clinical Trials

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    Full Text Available ... or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that ...

  9. Clinical Trials

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    Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are ...

  10. Clinical Trials

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    Full Text Available ... long and careful research process. The process often begins in a laboratory (lab), where scientists first develop ... IRB reviews the trial's protocol before the study begins. An IRB will only approve research that deals ...

  11. Clinical Trials

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    Full Text Available ... always, parents must give legal consent for their child to take part in a clinical trial. When ... minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  12. Clinical Trials

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    Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

  13. Clinical Trials

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    Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ... the new approach. You also will have the support of a team of health care providers, who ...

  14. Clinical Trials

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    Full Text Available ... States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for new medicines ...

  15. Clinical Trials

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    Full Text Available ... Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and ... drugs, and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical ...

  16. Clinical Trials

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    Full Text Available ... care providers might be part of your treatment team. They will monitor your health closely. You may ... taking part in a clinical trial. Your treatment team also may ask you to do other tasks. ...

  17. Clinical Trials

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    Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at cc-prpl@cc.nih.gov or call ...

  18. Clinical Trials

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    Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... medical centers, and hospitals. ClinicalTrials.gov View a database of clinical studies (past and present) funded or ...

  19. Clinical Trials

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ...

  20. Clinical Trials

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

  1. Clinical Trials

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    Full Text Available ... Masking, or "blinding," helps avoid bias. For this reason, researchers also may not be told which treatments ... from a study at any time, for any reason. Also, during the trial, you have the right ...

  2. Clinical Trials

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    Full Text Available ... clinical trials are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees all research ...

  3. Clinical Trials

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    Full Text Available ... you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking ... people will need to travel or stay in hospitals to take part in clinical trials. For example, ...

  4. Clinical Trials

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    Full Text Available ... include factors such as a patient's age and gender, the type and stage of disease, and whether ... in a clinical trial, find out ahead of time about costs and coverage. You should learn about ...

  5. Stroke Trials Registry

    Science.gov (United States)

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

  6. Experimental medicine 1000 years ago.

    Science.gov (United States)

    Abdel-Halim, Rabie E

    2011-05-01

    Little is known about the state of experimentation in the field of medicine during the Medieval Islamic era. With few exceptions, most of the contemporary sources on history of medicine propagate the idea that the roots of experimental medicine in its modern form, including clinical trials and drug-potency studies, first started during the European Renaissance in the 16(th) to the 18(th) centuries. This study is part of an ongoing multidisciplinary primary-source investigation of the original Arabic works of 11 Islamic medical scholars who lived and practiced between the 9(th) and the 13(th) centuries. The study critically evaluated and documented their contributions to the development of the scientific method and experimental medicine during that medieval Islamic era in several areas including critical appraisal of previous knowledge, clinical observations and case reports, clinical therapeutic trials, drug potency trials, experimentation on animals, dissection and dissection experiments as well as postmortem examinations. In each of the above-mentioned areas, significant contributions were made during the Medieval Islamic era from as early as the ninth century AD.

  7. Randomized Clinical Trials in Stroke Research

    OpenAIRE

    Ahn, Chul; Ahn, Daniel

    2010-01-01

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

  8. Animal experimentation.

    Science.gov (United States)

    Kolar, Roman

    2006-01-01

    Millions of animals are used every year in often times extremely painful and distressing scientific procedures. Legislation of animal experimentation in modern societies is based on the supposition that this is ethically acceptable when certain more or less defined formal (e.g. logistical, technical) demands and ethical principles are met. The main parameters in this context correspond to the "3Rs" concept as defined by Russel and Burch in 1959, i.e. that all efforts to replace, reduce and refine experiments must be undertaken. The licensing of animal experiments normally requires an ethical evaluation process, often times undertaken by ethics committees. The serious problems in putting this idea into practice include inter alia unclear conditions and standards for ethical decisions, insufficient management of experiments undertaken for specific (e.g. regulatory) purposes, and conflicts of interest of ethics committees' members. There is an ongoing societal debate about ethical issues of animal use in science. Existing EU legislation on animal experimentation for cosmetics testing is an example of both the public will for setting clear limits to animal experiments and the need to further critically examine other fields and aspects of animal experimentation.

  9. Publish, not perish: Introducing Experimental Hematology & Oncology

    OpenAIRE

    Li, Zihai; Hsueh, Chung-Tsen; Liu, Delong

    2012-01-01

    Abstract As a scientific discipline, medicine can only be advanced by experimentation. Experimentation could either validate or refute a hypothesis. Unfortunately, today's publication climate strongly favors publication of positive research findings, especially with clinical trials. Experimental Hematology & Oncology (eHO) is a new open access online journal that emphasizes preclinical, patient-oriented and translational aspects of research. The journal differentiates from others in the field...

  10. [Controlled randomized clinical trials].

    Science.gov (United States)

    Jaillon, Patrice

    2007-01-01

    It is generally agreed that the first comparative clinical trial in history was done by James Lind in 1747, in the treatment of scurvy. The general bases of modern experimental medicine were published by Claude Bernard in 1865. However, it is the development of new drugs and the evolution of methodological concepts that led to the first randomized controlled clinical trial, in 1948, which showed that the effects of streptomycin on pulmonary tuberculosis were significantly different from those of a placebo. Today, "evidence-based" medicine aims to rationalize the medical decision-making process by taking into account, first and foremost, the results of controlled randomized clinical trials, which provide the highest level of evidence. In the second half of the 20th century it became clear that different kinds of clinical trials might not provide the same level of evidence. Practitioners' intimate convictions must be challenged by the results of controlled clinical trials. Take the CAST trial for example, which, in 1989, tested antiarrhythmic drugs versus placebo in patients with myocardial infarction. It was well known that ventricular arrhythmias were a factor of poor prognosis in coronary heart disease, and it was therefore considered self-evident that drug suppression of these ventricular arrhythmias would reduce the mortality rate. In the event, the CAST trial showed the exact opposite, with an almost 3-fold increase in total mortality among patients with coronary heart disease who were treated with antiarrhythmic drugs. These results had a profound impact on the use of antiarrythmic drugs, which became contraindicated after myocardial infarction. A clinical trial has to fulfill certain methodological standards to be accepted as evidence-based medicine. First, a working hypothesis has to be formulated, and then the primary outcome measure must be chosen before beginning the study. An appropriate major endpoint for efficacy must be selected, in keeping with the

  11. Experimental macroevolution†

    Science.gov (United States)

    Bell, Graham

    2016-01-01

    The convergence of several disparate research programmes raises the possibility that the long-term evolutionary processes of innovation and radiation may become amenable to laboratory experimentation. Ancestors might be resurrected directly from naturally stored propagules or tissues, or indirectly from the expression of ancestral genes in contemporary genomes. New kinds of organisms might be evolved through artificial selection of major developmental genes. Adaptive radiation can be studied by mimicking major ecological transitions in the laboratory. All of these possibilities are subject to severe quantitative and qualitative limitations. In some cases, however, laboratory experiments may be capable of illuminating the processes responsible for the evolution of new kinds of organisms. PMID:26763705

  12. Acupuncture on experimental epilepsies.

    Science.gov (United States)

    Chen, R C; Huang, Y H

    1984-01-01

    The therapeutic effect of acupuncture on epilepsies was evaluated in 4 experimental models. 24 acupuncture points were tried. In electroconvulsive threshold model, square wave electrical stimulus of 0.2 msec and 6 Hz was applied through a pair of cotton electrodes at the cornea of mice for 3 sec. The stimulus intensity to induce stun reaction of the mouse was compared. In 86 control animals, the stimulus threshold was 0.70 +/- 0.22 mA. In the acupuncture treated group (N = 80), the threshold was 0.75 +/- 0.14 mA. In maximal electroshock model, the stimulus parameters were 60 Hz, 0.4 sec and 75 mA. The tonic extensor response of the hindlimbs of the mice was observed. 75.7% of the 115 control mice and 77.5% of the 80 acupuncture treated mice were observed to have tonic extensor response. In the focal cortical penicillin model, penicillin was applied at the subpial space over the exposed cortex of 24 cats. After the appearance of repeated spikes in ECoG, acupuncture was performed. In 175 trials the interictal spikes were decreased in 16 times, increased in 82 times. In 99 trials during seizures, the ictal activity was decreased in 4 times, increased in 79 times. In the intravenous penicillin model, high dose penicillin (1,000,000-1,500,000 U/kg) was given to 20 cats. It induced repetitive spikes and frequently even seizure discharges in EEG. Acupuncture was then tried. In 192 instances, acupuncture reduced the spikes in 13, increased the spikes in 103 times. In 74 trials during seizures, the ictal activity was suppressed in 4 times and aggravated in 66 times.(ABSTRACT TRUNCATED AT 250 WORDS)

  13. Clinical Trials

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    Full Text Available ... This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ...

  14. Clinical Trials

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    Full Text Available ... educational programs and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board ... of a group of research and study topic experts. The NIH also requires ...

  15. Clinical Trials

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    Full Text Available ... examples of clinical trials that test principles or strategies include studies that explore whether surgery or other medical treatments ... board consists of a group of research and study topic experts. The NIH also ... alternative strategies for diagnosis or treatment. In addition, the NIH ...

  16. The Trial

    Science.gov (United States)

    Bryant, Jen

    2004-01-01

    Growing up in Flemington, New Jersey, put Jen Bryant in the heart of the lore behind the Lindbergh baby kidnapping. Family stories of the events of the day and extensive research led to "The Trial," a novel in verse. The first several parts of this novel are included here.

  17. Clinical Trials

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    Full Text Available ... taking the same treatment the same way. These patients are closely watched by Data and Safety Monitoring Boards. Even if you don't directly ... risk procedures (such as gene therapy) or vulnerable patients (such as ... trial for safety problems or differences in results among different groups. ...

  18. Experimental macroevolution.

    Science.gov (United States)

    Bell, Graham

    2016-01-13

    The convergence of several disparate research programmes raises the possibility that the long-term evolutionary processes of innovation and radiation may become amenable to laboratory experimentation. Ancestors might be resurrected directly from naturally stored propagules or tissues, or indirectly from the expression of ancestral genes in contemporary genomes. New kinds of organisms might be evolved through artificial selection of major developmental genes. Adaptive radiation can be studied by mimicking major ecological transitions in the laboratory. All of these possibilities are subject to severe quantitative and qualitative limitations. In some cases, however, laboratory experiments may be capable of illuminating the processes responsible for the evolution of new kinds of organisms. © 2016 The Author(s).

  19. Experimental Methodology in English Teaching and Learning: Method Features, Validity Issues, and Embedded Experimental Design

    Science.gov (United States)

    Lee, Jang Ho

    2012-01-01

    Experimental methods have played a significant role in the growth of English teaching and learning studies. The paper presented here outlines basic features of experimental design, including the manipulation of independent variables, the role and practicality of randomised controlled trials (RCTs) in educational research, and alternative methods…

  20. Meet Clinical Trial Participants

    Science.gov (United States)

    ... page please turn JavaScript on. Feature: Clinical Trials Meet Clinical Trial Participants Past Issues / Fall 2016 Table ... Articles Clinical Trials, A Healthier Future for All / Meet Clinical Trial Participants / North Carolinians Volunteer for Knee ...

  1. Textbook of clinical trials

    National Research Council Canada - National Science Library

    Day, Simon; Machin, David; Green, Sylvan B

    2006-01-01

    ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 The Development of Clinical Trials Simon...

  2. Experimental music for experimental physics

    CERN Multimedia

    Rosaria Marraffino

    2014-01-01

    Using the sonification technique, physicist and composer Domenico Vicinanza paid homage to CERN at its 60th anniversary ceremony. After months of hard work, he turned the CERN Convention and LHC data into music.   Click here to download the full score of the "LHChamber music". Every birthday deserves gifts and CERN’s 60th anniversary was no exception. Two gifts were very special, thanks to the hard work of Domenico Vicinanza, a physicist and composer. He created two experimental pieces by applying the sonification technique to the CERN Convention and to data recorded by the four LHC detectors during Run 1. “This technique allows us to ‘hear’ data using an algorithm that translates numbers or letters into notes. It keeps the same information enclosed in a graph or a document, but has a more aesthetic exposition,” explains Domenico Vicinanza. “The result is meant to be a metaphor for scientific cooperation, in which d...

  3. Instrumented Suit Hard Upper Torso (HUT) for Ergonomic Assessment Project

    Data.gov (United States)

    National Aeronautics and Space Administration — Crewmembers undergo strenuous suited training for EVA missions. Frequent exposure to such activities can eventually lead to Cumulative Trauma Disorders/Injuries and...

  4. The Moral Trial: On Ethics and Economics

    OpenAIRE

    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 selfish, thus immoral, and it is recommended that we change the teaching of economics. I therefore disassemble the Moral Trial (Section I) and examine the psychological and logical soundness of both ev...

  5. Trial registration in pediatric surgery trials.

    Science.gov (United States)

    Rokhsefat, Sana; Morra, Deanna E; Offringa, Martin; Askie, Lisa M; Kelly, Lauren E

    2017-10-23

    Prospective clinical trial registration serves to increase transparency and to mitigate selective reporting bias. An assessment of adult surgical trials revealed poor trial registration practice with incomplete provision of information in registries and inconsistent information in the corresponding publication. The extent and completeness of pediatric surgical trial registration are unknown. We aimed to determine the proportion and adequacy of clinical trial registration in pediatric surgery trials published in 2014. Using sensitive search strategies in MEDLINE, abstracts and full-texts of prospective pediatric intervention studies published in 2014 were screened in duplicate. Pediatric surgical trials were included. Clinical trial registration numbers obtained from publications were searched in trial registries. Data were extracted based on WHO 20-item minimum data set to determine the completeness of registration data. The proportion of registered trials was recorded and registration data were compared to reported data in the corresponding publication. Our search and abstract screening identified 3375 articles for full text review. Following coding, a total of 54 pediatric surgical trials were included and analyzed; 28% (15/54) of which published a registration number. In trials which reported a registration number, 40% (6/15) were retrospectively registered and 40% (6/15) had made changes to their registered primary and/or secondary outcome measures. One included published trial reported an incorrect registration number. Analysis of pediatric surgery trials published in 2014 revealed a poor prospective trial registration rate and incomplete registration data. Our study supports future initiatives for improved registration behaviors in pediatric surgery trials to ensure high-quality, transparent, reproducible evidence is generated. Therapeutic (clinical trials), level II. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Are herders protected by their herds? An experimental analysis of zooprophylaxis against the malaria vector Anopheles arabiensis

    Directory of Open Access Journals (Sweden)

    Young Stephen

    2011-03-01

    Full Text Available Abstract Background The number of Anopheles arabiensis (Diptera: Culicidae and Anopheles pharoensis caught by human and cattle baits was investigated experimentally in the Arba Minch district of southern Ethiopia to determine if attraction to humans, indoors or outdoors, was affected by the presence or absence of cattle. Methods Field studies were made of the effect of a surrounding ring (10 m radius of 20 cattle on the numbers of mosquitoes collected by human-baited sampling methods (i inside or (ii outside a hut. Results The numbers of An. arabiensis caught outdoors by a human landing catch (HLC with or without a ring of cattle were not significantly different (2 × 2 Latin square comparisons: means = 24.8 and 37.2 mosquitoes/night, respectively; n = 12, P > 0.22, Tukey HSD, whereas, the numbers of An. pharoensis caught were significantly reduced (44% by a ring of cattle (4.9 vs. 8.7; n = 12, P An. arabiensis in human-baited traps (HBT was 25 times greater than in cattle-baited traps (CBT (34.0 vs. 1.3, n = 24; P An. pharoensis there was no significant difference. Furthermore, HBT and CBT catches were unaffected by a ring of cattle (4 × 4 Latin square comparison for either An. arabiensis (n = 48; P > 0.999 or An. pharoensis (n = 48, P > 0.870. The HLC catches indoors vs. outdoors were not significantly different for either An. arabiensis or An. pharoensis (n = 12, P > 0.969, but for An. arabiensis only, the indoor catch was reduced significantly by 49% when the hut was surrounded by cattle (Tukey HSD, n = 12, P > 0.01. Conclusions Outdoors, a preponderance of cattle (20:1, cattle:humans does not provide any material zooprophylactic effect against biting by An. arabiensis. For a human indoors, the presence of cattle outdoors nearly halved the catch. Unfortunately, this level of reduction would not have an appreciable impact on malaria incidence in an area with typically > 1 infective bite/person/night. For An. pharoensis, cattle significantly

  7. Using the Intervention Mapping protocol to develop a family-based intervention for improving lifestyle habits among overweight and obese children: study protocol for a quasi-experimental trial.

    Science.gov (United States)

    Stea, Tonje Holte; Haugen, Tommy; Berntsen, Sveinung; Guttormsen, Vigdis; Øverby, Nina Cecilie; Haraldstad, Kristin; Meland, Eivind; Abildsnes, Eirik

    2016-10-18

    In light of the high prevalence of childhood overweight and obesity, there is a need of developing effective prevention programs to address the rising prevalence and the concomitant health consequences. The main aim of the present study is to systematically develop and implement a tailored family-based intervention for improving lifestyle habits among overweight and obese children, aged 6-10 years old, enhancing parental self-efficacy, family engagement and parent-child interaction. A subsidiary aim of the intervention study is to reduce the prevalence of overweight and obesity among those participating in the intervention study. The Intervention Mapping protocol was used to develop a tailored family-based intervention for improving lifestyle habits among overweight and obese children. In order to gather information on local opportunities and barriers, interviews with key stakeholders and a 1-year pilot study was conducted. The main study has used a quasi-experimental controlled design. Locally based Healthy Life Centers and Public Health Clinics are responsible for recruiting families and conducting the intervention. The effect of the study will be measured both at completion of the 6 months intervention study and 6 and 18 months after the intervention period. An ecological approach was used as a basis for developing the intervention. The behavioral models and educational strategies include individual family counselling meetings, workshops focusing on regulation of family life, nutrition courses, and physical activity groups providing tailored information and practical learning sessions. Parents will be educated on how to use these strategies at home, to further support their children in improving their behaviors. A systematic and evidence-based approach was used for development of this family-based intervention study targeting overweight and obese children, 6-10 years old. This program, if feasible and effective, may be adjusted to local contexts and

  8. Effect of the Web-Based Intervention MyPlan 1.0 on Self-Reported Fruit and Vegetable Intake in Adults Who Visit General Practice: A Quasi-Experimental Trial.

    Science.gov (United States)

    Plaete, Jolien; Crombez, Geert; Van der Mispel, Celien; Verloigne, Maite; Van Stappen, Vicky; De Bourdeaudhuij, Ilse

    2016-02-29

    adults initially agreed to participate (control group: n=149; GPs' intervention group: n=41; researchers' intervention group: n=236). A high attrition rate was observed in both intervention groups (71.8%, 199/277) and in the control group (59.1%, 88/149). In comparison to no change in the control group, both the GPs' intervention group (fruit: χ(2)1=10.9, P=.004; vegetable: χ(2)1=5.3, P=.02) and the researchers' intervention group (fruit: χ(2)1=18.0, P=.001; vegetable: χ(2)1=12.8, PWeb-based intervention MyPlan 1.0 was used compared to usual care of health promotion in general practice (ie, flyers with general information). However, further investigation on which (or combinations of which) behavior change techniques are effective, how to increase response rates, and the influence of delivery mode in routine practice is required. ClinicalTrials.gov NCT02211040; https://clinicaltrials.gov/ct2/show/NCT02211040 (Archived by WebCite® at http://www.webcitation.org/6f8yxTRii).

  9. Evaluation of selective spraying of bendiocarb (Ficam VC) for the control of Anopheles flavirostris in the Philippines.

    Science.gov (United States)

    Asinas, C Y; Hugo, C T; Boase, C J; Evans, R G

    1994-12-01

    The effectiveness of selective and complete spray applications of bendiocarb for the control of the major malaria vector, Anopheles flavirostris, was compared in an experimental hut trial in the Philippines. Selective spraying involved treatment of the vector's preferred indoor resting sites, namely, the lower wall areas, wall areas immediately surrounding the doors and windows, and eaves. Complete spraying involved treatment of all internal wall and ceiling areas, and the eaves. At intervals over a 6-month period, mosquitoes were released into the huts and recaptured within 13 h, either inside the huts, or within the interior of net traps placed over the huts. Mortality levels differed by < 8% between the spray regimens over the posttreatment period, with both regimens giving 75-100% kill of An. flavirostris during the initial 3 months. The time spent spraying and spray volume used during treatment of village houses were respectively 36 and 49% less under the selective spraying regime. Selective application of bendiocarb therefore shows considerable promise, both in terms of efficacy and cost effectiveness, for the control of An. flavirostris in the Philippines.

  10. How Do Clinical Trials Work?

    Science.gov (United States)

    ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore whether ...

  11. Improving precision of forage yield trials: A case study

    Science.gov (United States)

    Field-based agronomic and genetic research relies heavily on the data generated from field evaluations. Therefore, it is imperative to optimize the precision of yield estimates in cultivar evaluation trials to make reliable selections. Experimental error in yield trials is sensitive to several facto...

  12. The Medical Ethics of Clinical Therapeutic Trials*

    African Journals Online (AJOL)

    Clinical therapeutic trials, or human experimentation with drugs, are abso- lutely necessary, because data gained from experiments on animals cannot always be directly extrapolated onto man as being applicable. Variations are also found in the different animal species. Tt is impossible to obtain data in animals regarding.

  13. 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

  14. [Radiotherapy phase I trials' methodology: Features].

    Science.gov (United States)

    Rivoirard, R; Vallard, A; Langrand-Escure, J; Guy, J-B; Ben Mrad, M; Yaoxiong, X; Diao, P; Méry, B; Pigne, G; Rancoule, C; Magné, N

    2016-12-01

    In clinical research, biostatistical methods allow the rigorous analysis of data collection and should be defined from the trial design to obtain the appropriate experimental approach. Thus, if the main purpose of phase I is to determine the dose to use during phase II, methodology should be finely adjusted to experimental treatment(s). Today, the methodology for chemotherapy and targeted therapy is well known. For radiotherapy and chemoradiotherapy phase I trials, the primary endpoint must reflect both effectiveness and potential treatment toxicities. Methodology should probably be complex to limit failures in the following phases. However, there are very few data about methodology design in the literature. The present study focuses on these particular trials and their characteristics. It should help to raise existing methodological patterns shortcomings in order to propose new and better-suited designs. Copyright © 2016 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

  15. Experimental Engineering: Articulating and Valuing Design Experimentation

    DEFF Research Database (Denmark)

    Vallgårda, Anna; Grönvall, Erik; Fritsch, Jonas

    2017-01-01

    In this paper we propose Experimental Engineering as a way to articulate open- ended technological experiments as a legitimate design research practice. Experimental Engineering introduces a move away from an outcome or result driven design process towards an interest in existing technologies...

  16. 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.

  17. Feasibility of feature-based indexing, clustering, and search of clinical trials. A case study of breast cancer trials from ClinicalTrials.gov.

    Science.gov (United States)

    Boland, M R; Miotto, R; Gao, J; Weng, C

    2013-01-01

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

  18. Adaptive Programming Improves Outcomes in Drug Court: An Experimental Trial.

    Science.gov (United States)

    Marlowe, Douglas B; Festinger, David S; Dugosh, Karen L; Benasutti, Kathleen M; Fox, Gloria; Croft, Jason R

    2012-04-01

    Prior studies in Drug Courts reported improved outcomes when participants were matched to schedules of judicial status hearings based on their criminological risk level. The current experiment determined whether incremental efficacy could be gained by periodically adjusting the schedule of status hearings and clinical case-management sessions in response to participants' ensuing performance in the program. The adjustments were made pursuant to a priori criteria specified in an adaptive algorithm. Results confirmed that participants in the full adaptive condition (n = 62) were more than twice as likely as those assigned to baseline-matching only (n = 63) to be drug-abstinent during the first 18 weeks of the program; however, graduation rates and the average time to case resolution were not significantly different. The positive effects of the adaptive program appear to have stemmed from holding noncompliant participants more accountable for meeting their attendance obligations in the program. Directions for future research and practice implications are discussed.

  19. Solar disinfection of drinking water and diarrhoea in Maasai children: a controlled field trial.

    Science.gov (United States)

    Conroy, R M; Elmore-Meegan, M; Joyce, T; McGuigan, K G; Barnes, J

    Solar radiation reduces the bacterial content of water, and may therefore offer a method for disinfection of drinking water that requires few resources and no expertise. We distributed plastic water bottles to 206 Maasai children aged 5-16 years whose drinking water was contaminated with faecal coliform bacteria. Children were instructed to fill the bottle with water and leave it in full sunlight on the roof of the hut (solar group), or to keep their filled bottles indoors in the shade (control group). A Maasai-speaking fieldworker who lived in the community interviewed the mother of each child once every 2 weeks for 12 weeks. Occurrence and severity of diarrhoea was recorded at each follow-up visit. Among the 108 children in households allocated solar treatment, diarrhoea was reported in 439 of the 2-week reporting periods during the 12-week trial (average 4.1 [SD 1.2] per child). By comparison, the 98 children in the control households reported diarrhoea during 444 2-week reporting periods (average 4.5 [1.2] per child). Diarrhoea severe enough to prevent performance of duties occurred during 186 reporting periods in the solar group and during 222 periods in the control group (average 1.7 [1.2] vs 2.3 [1.4]). After adjustment for age, solar treatment of drinking water was associated with a reduction in all diarrhoea episodes (odds ratio 0.66 [0.50-0.87]) and in episodes of severe diarrhoea (0.65 [0.50-0.86]). Our findings suggest that solar disinfection of water may significantly reduce morbidity in communities with no other means of disinfection of drinking water, because of lack of resources or in the event of a disaster.

  20. 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

    National Research Council Canada - National Science Library

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

    2015-01-01

    .... 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...

  1. Clinical trials in rhinosinusitis: Identifying areas for improvement.

    Science.gov (United States)

    Ramsey, Tam; Lai, Wanda; Guo, Eric; Svider, Peter F; Zuliani, Giancarlo; Eloy, Jean Anderson; Folbe, Adam J

    2017-11-06

    To characterize trends in rhinosinusitis clinical trials to provide recommendations for therapeutic directions, highlight possible redundancy, and provide a framework for prioritization of future clinical trials. Database analysis. Data were collected from ClinicalTrials.gov including all clinical trials that focused on rhinosinusitis with the exclusion of trials withdrawn prior to enrollment. Variables recorded included study design, study population, pharmaceutical involvement, publication, and whether a trial was a medical or surgical intervention. Associated publications were identified using the PubMed, Embase, and Cochrane databases. There were 269 rhinosinusitis clinical trials, dating from 1993 to 2017, that met inclusion reauirements. Of the studies included in this analysis, 51.7% had at least one scientific publication, and of those with publications, 80.6% had positive results and 19.3% had negative results. Twenty-three clinical trials (8.5%) studied drugs already approved for rhinosinusitis, 113 (42.0%) trials studied drugs that were approved for other uses, 42 (15.6%) trials studied experimental drugs, and 102 (39.4%) studied surgical intervention. Of the trials studying drugs, the data showed many clinical trials that studied the same drug. The data demonstrate a steady decline in clinical trials with medical intervention and a rise in clinical trials with surgical intervention. This analysis is the first to characterize rhinosinusitis clinical trials, highlighting the over-representation of certain drugs and demonstrating an increased focus on clinical trials employing surgical intervention. We provide a framework to discuss prioritization of future studies to guide clinical and research practice. 4. Laryngoscope, 2017. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

  2. Soil fertility management in pasture small-plot trials: potential pitfalls ...

    African Journals Online (AJOL)

    Small-plot cutting trials are of particular importance in research relating to intensive pastures. Undetected changes in soil fertility during the course of experimentation may detract from the validity of results in trials of this kind. Information from field trials conducted in KwaZulu-Natal during the past two decades are used to ...

  3. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    "Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide...

  4. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... and Public Home » Hepatitis C » Treatment Decisions Viral Hepatitis Menu Menu Viral Hepatitis Viral Hepatitis Home For ... can I find out about participating in a hepatitis C clinical trial? Many trials are being conducted ...

  5. Informed Consent (Clinical Trials)

    Science.gov (United States)

    ... Cancer Treatment Types of Cancer Treatment Side Effects Clinical Trials Information A to Z List of Cancer Drugs ... Staging Prognosis Treatment Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer ...

  6. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  7. Clinical trials of homoeopathy

    NARCIS (Netherlands)

    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

  8. Clinical Research and Clinical Trials

    Science.gov (United States)

    ... Contracts section of the NIH website. Find NICHD Clinical Trials NIH maintains the ClinicalTrials.gov website as the main database of publicly and privately funded clinical trials. Each trial has its own pre-defined research ...

  9. HIRENASD Experimental Data

    Data.gov (United States)

    National Aeronautics and Space Administration — Experimental Data for HIRENASD configuration Zip files below contain the experimental data for the pressure coefficients, both the static and the forced oscillation...

  10. Ethics in Animal Experimentation

    Directory of Open Access Journals (Sweden)

    Yusuf Ergun

    2010-08-01

    Full Text Available Experimental animals are frequently used to obtain information for primarily scientific reasons. In the present review, ethics in animal experimentation is examined. At first, the history of animal experimentation and animal rights is outlined. Thereafter, the terms in relation with the topic are defined. Finally, prominent aspects of 3Rs constituting scientific and ethical basis in animal experimentation are underlined. [Archives Medical Review Journal 2010; 19(4.000: 220-235

  11. Ethics in Animal Experimentation

    OpenAIRE

    Yusuf Ergun

    2010-01-01

    Experimental animals are frequently used to obtain information for primarily scientific reasons. In the present review, ethics in animal experimentation is examined. At first, the history of animal experimentation and animal rights is outlined. Thereafter, the terms in relation with the topic are defined. Finally, prominent aspects of 3Rs constituting scientific and ethical basis in animal experimentation are underlined. [Archives Medical Review Journal 2010; 19(4.000): 220-235

  12. Microexperiencia Educativa (Microeducational Experimentation).

    Science.gov (United States)

    Burton Meis, Roberto

    1970-01-01

    Experimentation for educational reform in Argentina is limited to specifically designated schools which are to be in a permanent state of experimentation. This article presents the official statements designating the experimental schools and includes remarks covering administration, evaluation, and supervision. (VM)

  13. Fundamentals of Experimental Pharmacology

    National Research Council Canada - National Science Library

    Bhatt, J

    2012-01-01

    ... or in human volunteers. Thus, an experimental pharmacology using animal models continues to be the starting point for a new drug research. The book Fundamentals of Experimental Pharmacology by Dr. M. N. Ghosh has really been a cornerstone for postgraduate students and researchers engaged in animal experimentation. It has always been useful for pos...

  14. The COLOFOL trial

    DEFF Research Database (Denmark)

    Hansdotter Andersson, Pernilla; Wille-Jørgensen, Peer; Horváth-Puhó, Erzsébet

    2016-01-01

    INTRODUCTION: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL...... trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study. MATERIALS AND METHODS: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient...... and localization. The analyses will be stratified by these variables. Taken together, we conclude that our trial results will be robust and possible to extrapolate to the target population....

  15. Construction of Virtual Psychology Laboratory Describing Exploratory Experimental Behavior

    Science.gov (United States)

    Nakaike, Ryuichi; Miwa, Kazuhisa

    In the present study, we show a simulated experiment environment, VPL(Virtual Psychology Laboratory), for visualizing user's exploratory experimental behavior, and present two main modules of the environment: (1) a cognitive simulator and (2) a system for automatically describing experimenter's behavior based on EBS (Exploratory Behavior Schema) proposed by the author. Users use this environment as an experimental psychologist who investigates human collaborative discovery. They experience many trials of conducting experiments using the simulated environment, and analyze by themselves their experimental processes based on the description of their behavior by EBS. It is expected that learners can notice their errors of experimental planning and refine various types of knowledge related to the experimental skills by repeating the experimental activities in this environment.

  16. Is animal experimentation fundamental?

    Science.gov (United States)

    d'Acampora, Armando José; Rossi, Lucas Félix; Ely, Jorge Bins; de Vasconcellos, Zulmar Acciolli

    2009-01-01

    The understanding about the utilization of experimental animals in scientific research and in teaching is many times a complex issue. Special attention needs to be paid to attain the understanding by the general public of the importance of animal experimentation in experimental research and in undergraduate medical teaching. Experimental teaching and research based on the availability of animals for experimentation is important and necessary for the personal and scientific development of the physician-to-be. The technological arsenal which intends to mimic experimentation animals and thus fully replace their use many times does not prove to be compatible with the reality of the living animal. The purpose of this paper is to discuss aspects concerning this topic, bringing up an issue which is complex and likely to arouse in-depth reflections.

  17. Transonic Experimental Research Facility

    Data.gov (United States)

    Federal Laboratory Consortium — The Transonic Experimental Research Facility evaluates aerodynamics and fluid dynamics of projectiles, smart munitions systems, and sub-munitions dispensing systems;...

  18. 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.

  19. Fundamentals of Experimental Pharmacology

    National Research Council Canada - National Science Library

    Ghosh, M

    2007-01-01

    ... to its unique approach in comparison to other books available on Experimental pharmacology. The main purpose of this book was to give a theoretical background followed by the appropriate experimental techniques. The late Prof. H. O. Schild, then Professor of Pharmacology, University College London in his brief introduction to the first editi...

  20. Theory-laden experimentation

    DEFF Research Database (Denmark)

    Schindler, Samuel

    2013-01-01

    The thesis of theory-ladenness of observations, in its various guises, is widely considered as either ill-conceived or harmless to the rationality of science. The latter view rests partly on the work of the proponents of New Experimentalism who have argued, among other things, that experimental p...

  1. Introduction: Experimental Green Strategies

    DEFF Research Database (Denmark)

    Peters, Terri

    2011-01-01

    Defining new ways in which archietcts are responding to the challenge of creating sustainable architecture , Experimental Green Strategies present a state of the art in applied ecological architectural research.......Defining new ways in which archietcts are responding to the challenge of creating sustainable architecture , Experimental Green Strategies present a state of the art in applied ecological architectural research....

  2. Strength of Experimental Grouts

    DEFF Research Database (Denmark)

    Sørensen, Eigil V.

     The present report describes tests carried out on 5 experimental grouts developed by BASF Construction Materials and designed for use in grouted connections of offshore windmill foundations....... The present report describes tests carried out on 5 experimental grouts developed by BASF Construction Materials and designed for use in grouted connections of offshore windmill foundations....

  3. Could phase 3 medicine trials be tagged as pragmatic? A case study: The Salford COPD trial.

    Science.gov (United States)

    Dal-Ré, Rafael

    2017-07-07

    Randomized clinical trials (RCTs) can be classified as explanatory or pragmatic. Currently, explanatory and pragmatic are considered to be the extremes of a continuum: Many trials have some features of both explanatory and pragmatic RCTs. The Salford Chronic Obstructive Respiratory Disease (COPD) trial was an open-label phase 3 RCT assessing an experimental product (fluticasone furoate-vilanterol) vs usual care. The Salford investigators labelled it as "the world's first phase 3 pragmatic RCT" in COPD patients. The evaluation of the Salford trial by means of the PRECIS-2 tool, yielded a mix of both extremes (explanatory and pragmatic) with several of the 9 domains close to the explanatory extreme and few to the pragmatic one. A number of the features could not be considered as being minimal changes over usual clinical practice. Hence, it would be difficult to accept that the Salford COPD trial was a pragmatic RCT. In addition, all trial participants could have been subject to the Hawthorne effect. The scientific community needs to be rigorous enough when using certain terms related to RCT. It is clear that the Salford COPD trial had particular features-sharing some of explanatory phase 3 RCTs and some of pragmatic RCTs. This, however, is not enough to tag it as a "pragmatic" RCT providing "real-world" data. These words should not be used when referring to prelicensed RCT, unless they really describe how was the trial conducted and the type of data gathered-something that with the current clinical trial regulations will only occur in very rare circumstances. © 2017 John Wiley & Sons, Ltd.

  4. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...

  5. Clinical trial structures

    OpenAIRE

    Evans, Scott R.

    2010-01-01

    Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is crucial. The selection of a clinical trial design structure requires logic and creativity. Common structural designs are discussed.

  6. The OA Trial Bank

    DEFF Research Database (Denmark)

    van Middelkoop, Marienke; Arden, N K; Atchia, I.

    2016-01-01

    Objective: To evaluate the efficacy of intra-articular (IA) glucocorticoids for knee or hip osteoarthritis (OA) in specific subgroups of patients with severe pain and inflammatory signs using individual patient data (IPD) from existing trials. Design: Randomized trials evaluating one or more IA g...

  7. 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

  8. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...... both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials...... and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety...

  9. 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.

  10. Ultrasound v. sham ultrasound for experimentally induced delayed ...

    African Journals Online (AJOL)

    In a double-blind controlled trial, delayed-onset muscle soreness (DOMS) was experimentally induced in both bicep muscles of 15 females. Sham US was applied to one bicep (n=15 biceps) and pulsed active US to the other bicep (n=15 biceps) of each participant, 48 and 72 h after induction of DOMS. Primary and ...

  11. Experimental approaches and applications

    CERN Document Server

    Crasemann, Bernd

    1975-01-01

    Atomic Inner-Shell Processes, Volume II: Experimental Approaches and Applications focuses on the physics of atomic inner shells, with emphasis on experimental aspects including the use of radioactive atoms for studies of atomic transition probabilities. Surveys of modern techniques of electron and photon spectrometry are also presented, and selected practical applications of inner-shell processes are outlined. Comprised of six chapters, this volume begins with an overview of the general principles underlying the experimental techniques that make use of radioactive isotopes for inner-sh

  12. Experimental semiotics: a review.

    Science.gov (United States)

    Galantucci, Bruno; Garrod, Simon

    2011-01-01

    In the last few years a new line of research has appeared in the literature. This line of research, which may be referred to as experimental semiotics (ES; Galantucci, 2009; Galantucci and Garrod, 2010), focuses on the experimental investigation of novel forms of human communication. In this review we will (a) situate ES in its conceptual context, (b) illustrate the main varieties of studies thus far conducted by experimental semioticians, (c) illustrate three main themes of investigation which have emerged within this line of research, and (d) consider implications of this work for cognitive neuroscience.

  13. 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

  14. Clinical trial registration in fertility trials - a case for improvement?

    Science.gov (United States)

    Farquhar, Cynthia M; Showell, Marian G; Showell, Emily A E; Beetham, Penny; Baak, Nora; Mourad, Selma; Jordan, Vanessa M B

    2017-09-01

    What is the prevalence and source of prospectively and retrospectively registered and unregistered trials in fertility treatments? Trial registration is low and does not appear to be changing over the 5 years studied. Trial registration is associated with lower risk of bias than in unregistered trials. The Cochrane Gynaecology and Fertility Group's specialised register was searched on 5 November 2015 for randomised controlled trials (RCTs) published from January 2010 to December 2014. Eligible trials included randomised women or men for fertility treatments, were published in full text, and written in English. Two reviewers independently assessed trial registration status for each trial, by searching the publication, trial registries, and by contacting the original authors. Of 693 eligible RCTS, only 44% were registered trials. Of 309 registered trials, 21.7% were prospectively registered, 15.8% were registered within 6 months of first patient enrolment and 62.5% were retrospectively registered trials. Prospective trial registration by country varied from 0% to 100%. The highest frequency of prospective trial registration amongst the top 10 publishing countries was 31% in the Netherlands. Only English language trials were included in this review. Prospective trial registration is still low. Journals, funders and ethics committees could have a greater role to increase trial registration. University of Auckland. No competing interests.

  15. Comparison of German and American law concerning clinical trials.

    Science.gov (United States)

    Deutsch, E

    1983-01-01

    In German and American law, clinical trials require a positive benefit-risk evaluation, free and informed consent, medical and scientific qualification of the doctor, and a written research protocol. American law requires a written consent, which is free of undue influence, the subject being instructed that he is free to withdraw from the trial. In German law, an orally given consent is sufficient for therapeutic trials. With minor or incompetent research subjects, informed consent to therapeutic clinical experimentation has to be given by their parents or guardians, the permissibility of which, in other trials, is controversial. In non-therapeutic trials, blind studies, double-bind studies, and trials involving placebos, special attention has to be paid to the risk-benefit analysis and to informed consent, which in these cases, even in Germany, must be written. The most outstanding feature of American law of clinical trial is that the experimentation is subject to previous control and approval by institutional review boards. The most interesting difference in German law is the investigator's duty to effect an insurance against the risks of the research subject's death or invalidity.

  16. Experimental economics in antitrust

    NARCIS (Netherlands)

    Normann, H.T.; Müller, W.; Blair, R.D.; Sokol, D.D.

    2015-01-01

    This chapter assesses the scope and the specific contribution of laboratory experiments for antitrust. It reviews experiments that have addressed specific antitrust issues, problems, and institutions. The chapter mainly covers experimental studies on collusion (tacit and explicit, conscious

  17. Nuclear test experimental science

    Energy Technology Data Exchange (ETDEWEB)

    Struble, G.L.; Middleton, C.; Bucciarelli, G.; Carter, J.; Cherniak, J.; Donohue, M.L.; Kirvel, R.D.; MacGregor, P.; Reid, S. (eds.)

    1989-01-01

    This report discusses research being conducted at Lawrence Livermore Laboratory under the following topics: prompt diagnostics; experimental modeling, design, and analysis; detector development; streak-camera data systems; weapons supporting research.

  18. The Experimental Art School

    DEFF Research Database (Denmark)

    Ørum, Tania

    2014-01-01

    The article describes the Experimental Art School from its early beginnings, its development from formal experiments to political action, the question of gender and politics, and the power of the self-organised......The article describes the Experimental Art School from its early beginnings, its development from formal experiments to political action, the question of gender and politics, and the power of the self-organised...

  19. Frozen waves: experimental generation

    OpenAIRE

    Vieira, TA; Gesualdi, MRR; Zamboni-Rached, M

    2012-01-01

    Frozen waves (FWs) are very interesting particular cases of nondiffracting beams whose envelopes are static and whose longitudinal intensity patterns can be chosen a priori. We present here for the first time (that we know of) the experimental generation of FWs. The experimental realization of these FWs was obtained using a holographic setup for the optical reconstruction of computer generated holograms (CGH), based on a 4-f Fourier filtering system and a nematic liquid crystal spatial light ...

  20. 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 ...

  1. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

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

  2. Clinical Trials - Multiple Languages

    Science.gov (United States)

    ... clínicos: Tema de salud de MedlinePlus - español (Spanish) National Library of Medicine Clinical Trials - English ... PDF American Cancer Society Characters not displaying correctly on this page? See language ...

  3. Anchor Trial Launch

    Science.gov (United States)

    NCI has launched a multicenter phase III clinical trial called the ANCHOR Study -- Anal Cancer HSIL (High-grade Squamous Intraepithelial Lesion) Outcomes Research Study -- to determine if treatment of HSIL in HIV-infected individuals can prevent anal canc

  4. ClinicalTrials.gov

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  5. Randomized trial of treadmill walking with body weight support to establish walking in subacute stroke: the MOBILISE trial.

    Science.gov (United States)

    Ada, Louise; Dean, Catherine M; Morris, Meg E; Simpson, Judy M; Katrak, Pesi

    2010-06-01

    The main objective of this randomized trial was to determine whether treadmill walking with body weight support was effective at establishing independent walking more often and earlier than current physiotherapy intervention for nonambulatory stroke patients. A randomized trial with concealed allocation, blinded assessment, and intention-to-treat analysis was conducted. One hundred twenty-six stroke patients who were unable to walk were recruited and randomly allocated to an experimental or a control group within 4 weeks of stroke. The experimental group undertook up to 30 minutes per day of treadmill walking with body weight support via an overhead harness whereas the control group undertook up to 30 minutes of overground walking. The primary outcome was the proportion of participants achieving independent walking within 6 months. Kaplan-Meier estimates of the proportion of experimental participants who achieved independent walking were 37% compared with 26% of the control group at 1 month, 66% compared with 55% at 2 months, and 71% compared with 60% at 6 months (P=0.13). The experimental group walked 2 weeks earlier, with a median time to independent walking of 5 weeks compared to 7 weeks for the control group. In addition, 14% (95% CI, -1-28) more of the experimental group were discharged home. Treadmill walking with body weight support is feasible, safe, and tends to result in more people walking independently and earlier after stroke. Trial Registration- ClinicalTrial.gov (NCT00167531).

  6. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For each...... relating to obsolescence, fidelity of intervention delivery, and adherence and crossover. Assessment and analysis raise questions regarding blinding and clustering of observations. This paper describes methodological problems in the design and conduct of surgical randomized trials and proposes strategies...

  7. Amiodarone: clinical trials.

    Science.gov (United States)

    Naccarelli, G V; Wolbrette, D L; Patel, H M; Luck, J C

    2000-01-01

    Amiodarone is an antiarrhythmic agent commonly used in the treatment of supraventricular and ventricular tachyarrhythmias. This article reviews the results and clinical implications of primary and secondary prevention trials in which amiodarone was used in one of the treatment arms. Key post-myocardial infarction primary prevention trials include the European Myocardial Infarct Amiodarone Trial (EMIAT) and the Canadian Amiodarone Myocardial Infarction Trial (CAMIAT), both of which demonstrated that amiodarone reduced arrhythmic but not overall mortality. In congestive heart failure patients, amiodarone was studied as a primary prevention strategy in two pivotal trials: Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiac en Argentina (GESICA) and Amiodarone in Patients With Congestive Heart Failure and Asymptomatic Ventricular Arrhythmia (CHF-STAT). Amiodarone was associated with a neutral overall survival and a trend toward improved survival in nonischemic cardiomyopathy patients in CHF/STAT and improved survival in GESICA. In post-myocardial infarction patients with nonsustained ventricular tachycardia and a depressed ejection fraction, the Multicenter Automatic Defibrillator Implantation Trial (MADIT) demonstrated that implantable cardioverter-defibrillators (ICD) statistically improved survival compared to the antiarrhythmic drug arm, most of whose patients were taking amiodarone. In patients with histories of sustained ventricular tachycardia or ventricular fibrillation, the Cardiac Arrest Study in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) trial demonstrated that empiric amiodarone lowered arrhythmic recurrence rates compared to other drugs guided by serial Holter or electrophysiologic studies. However, arrhythmic death rates were high in both treatment arms of the study. Several secondary prevention trials, including the Antiarrhythmics Versus Implantable Defibrillators Study (AVID), the Canadian Implantable Defibrillator Study

  8. Fundamentals of clinical trial design

    OpenAIRE

    Evans, Scott R.

    2010-01-01

    Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is crucial. Issues in trial conduct and analyses should be anticipated during trial design and thoughtfully addressed. Fundamental clinical trial design issues are discussed.

  9. Experimental Research in Marketing

    Directory of Open Access Journals (Sweden)

    Jose Mauro Hernandez

    2014-05-01

    Full Text Available Considering the growing number of scientific studies published in the marketing field and the development of unique theories of the area (Hunt, 2010, using experimental designs seems increasingly appropriate to investigate marketing phenomena. This article aims to discuss the main elements in conducting experimental studies and also to stimulate researchers to adopt this research method. Several international journals (e.g., JCR, JCP, JMR, JR, JBR have been publishing articles based on experiments that not only demonstrate a relationship between two events, but also elucidate how they occur by means of mediation and moderation analyses. This article intents to be a roadmap for novice researchers on how to conduct experiments and to offer new perspectives in experimental research for experienced researchers.  

  10. Self-experimentation.

    Science.gov (United States)

    Davis, John K

    2003-01-01

    Except in certain cases of unusual risk, self-experimentation should not be encouraged. It is usually scientifically inadequate for lack of proper controls and sufficient subjects to generate meaningful results. It is also inadequate as an ethical test because even if lay persons are also enrolled, self-experimentation is neither necessary nor sufficient to establish that they may participate. It is not necessary to establish that lay persons may participate because institutional ethics review and informed consent are better ways to determine this. It is not sufficient because the investigator may be more risk accepting or not medically typical. Moreover, because scientific research is now done in teams, self-experimentation may involve undue influence when junior investigators participate as research subjects.

  11. Knockout reactions: experimental aspects

    Energy Technology Data Exchange (ETDEWEB)

    Cortina Gil, D. [Santiago de Compostela Univ. (Spain)

    2007-07-01

    The availability of radioactive beams has given rise to intense activity in the field of direct reactions. The removal of one(two)-nucleon (referred to as nucleon knockout in this text) from a fast exotic projectile has been extensively investigated. This lecture provides a general overview of the experimental results achieved using this technique. The sensitivity of the method to different experimental aspects is illustrated with a few examples. Special attention is given to the application of nucleon-knockout reactions as a general purpose spectroscopic tool. (author)

  12. Experimental headache in humans

    DEFF Research Database (Denmark)

    Iversen, Helle Klingenberg

    1995-01-01

    The need for valid human experimental models of headache is obvious. Several compounds have been proposed as headache-inducing agents, but only the nitroglycerin (NTG) model has been validated. In healthy subjects, intravenous infusions of the nitric oxide (NO) donor NTG induce a dose-dependent h......The need for valid human experimental models of headache is obvious. Several compounds have been proposed as headache-inducing agents, but only the nitroglycerin (NTG) model has been validated. In healthy subjects, intravenous infusions of the nitric oxide (NO) donor NTG induce a dose...

  13. Music listening for anxiety relief in children in the preoperative period: a randomized clinical trial

    National Research Council Canada - National Science Library

    Franzoi, Mariana André Honorato; Goulart, Cristina Bretas; Lara, Elizabete Oliveira; Martins, Gisele

    2016-01-01

    ...: randomized controlled clinical trial pilot study with 52 children in the preoperative period, aged 3 to 12 years, undergoing elective surgery and randomly allocated in the experimental group (n = 26) and control group (n = 26...

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

    African Journals Online (AJOL)

    A placebo-controlled clinical trial is a trial where some of the volunteers are given the new drug being tested, and the other volunteers are given a placebo. A placebo looks exactly like the experimental drugs in every respect both in appearance and wrappings which, is prescribed in identical way to the real drug.

  15. 78 FR 49444 - Oral Rabies Vaccine Trial; Availability of a Supplement to an Environmental Assessment and...

    Science.gov (United States)

    2013-08-14

    ... Animal and Plant Health Inspection Service Oral Rabies Vaccine Trial; Availability of a Supplement to an... efficacy of an experimental oral rabies vaccine for wildlife in New Hampshire, New York, Ohio, Vermont, and... potential environmental impact associated with our oral rabies vaccine field trial. The finding, which is...

  16. 76 FR 56731 - Oral Rabies Vaccine Trial; Availability of an Environmental Assessment and Finding of No...

    Science.gov (United States)

    2011-09-14

    ... Animal and Plant Health Inspection Service Oral Rabies Vaccine Trial; Availability of an Environmental... safety and efficacy of an experimental oral rabies vaccine for wildlife in West Virginia. \\1\\ To view the... implementation of a field trial to test the safety and efficacy of the AdRG1.3 wildlife rabies vaccine in...

  17. 77 FR 49409 - Oral Rabies Vaccine Trial; Availability of an Environmental Assessment and Finding of No...

    Science.gov (United States)

    2012-08-16

    ... Animal and Plant Health Inspection Service Oral Rabies Vaccine Trial; Availability of an Environmental... with the proposed field trial to test the safety and efficacy of an experimental oral rabies vaccine....3 wildlife rabies vaccine in New Hampshire, New York, Ohio, Vermont, and West Virginia, including...

  18. 77 FR 40322 - Oral Rabies Vaccine Trial; Availability of an Environmental Assessment

    Science.gov (United States)

    2012-07-09

    ... Animal and Plant Health Inspection Service Oral Rabies Vaccine Trial; Availability of an Environmental... experimental rabies vaccine in field safety and immunogenicity trials in portions of New Hampshire, New York... distribution of baits containing vaccinia-rabies glycoprotein (V-RG) vaccine to stop the spread of specific...

  19. Administrative Aspects of Human Experimentation.

    Science.gov (United States)

    Irvine, George W.

    1992-01-01

    The following administrative aspects of scientific experimentation with human subjects are discussed: the definition of human experimentation; the distinction between experimentation and treatment; investigator responsibility; documentation; the elements and principles of informed consent; and the administrator's role in establishing and…

  20. Outsourcing of experimental work

    DEFF Research Database (Denmark)

    Nielsen, Henrik

    2011-01-01

    With the development of new technologies for simultaneous analysis of many genes, transcripts, or proteins (the "omics" revolution), it has become common to outsource parts of the experimental work. In order to maintain the integrity of the research projects, it is important that the interphase...

  1. Aspects of Experimental Hepatocarcinogenesis

    African Journals Online (AJOL)

    1974-04-06

    Apr 6, 1974 ... The remaining articles in this series are: Part Il-Hyperplastic nodules; Part Ill-Iron overload and hepatocarcinogenesis; Part IV-Changes in the liver fol- lowing cessation of carcinogen administration; Part V-. The ultrastructural morphology of early hepatocellular carcinomas. EXPERIMENTAL METHOD.

  2. Experimental high energy physics

    CERN Document Server

    De Paula, L

    2004-01-01

    A summary of the contributions on experimental high energy physics to the XXIV Brazilian National Meeting on Particle and Fields is presented. There were 5 invited talks and 32 submitted contributions. The active Brazilian groups are involved in several interesting projects but suffer from the lack of funding and interaction with Brazilian theorists.

  3. Experimental status of physics

    Indian Academy of Sciences (India)

    In a short period of time, we will have a large amount of results from -factories including ones on CP violation. In this talk, we briefly review the current experimental status of -physics. After a quick description of -facilities, we divide this vast field into two categories: (1) weak interaction and QCD, (2) unitarity triangle and ...

  4. Experimental Search for Pentaquarks

    CERN Document Server

    Hicks, K

    2005-01-01

    The experimental evidence for pentaquarks, both old an new, is discussed. Constraints due to $K^+N$ scattering data from previous decades is first reviewed, followed by experiments with positive evidence and those with null results. Finally, the problem of the narrow width of the Theta+ pentaquark is discussed, along with theoretical implications.

  5. Dr Ahmed Experimental

    African Journals Online (AJOL)

    Dr. Ahmed

    possible to directly determine the infection rates from the flies caught off the experimental animals. This was estimated through the dissection of 180 flies trapped from several sites within the. LGA using Nitse trap (Omoogun 1994) and Biconical trap. (Challier & Larvessiere 1973). The trypanosoma species were identified by ...

  6. Trends in animal experimentation.

    Science.gov (United States)

    Monteiro, Rosangela; Brandau, Ricardo; Gomes, Walter J; Braile, Domingo M

    2009-01-01

    The search of the understanding of etiological factors, mechanisms and treatment of the diseases has been taking to the development of several animal models in the last decades. To discuss aspects related to animal models of experimentation, animal choice and current trends in this field in our country. In addition, this study evaluated the frequency of experimental articles in medical journals. Five Brazilian journals indexed by LILACS, SciELO, MEDLINE, and recently incorporate for Institute for Scientific Information Journal of Citation Reports were analyzed. All the papers published in those journals, between 2007 and 2008, that used animal models, were selected based on the abstracts. Of the total of 832 articles published in the period, 92 (11.1%) experimentation papers were selected. The number of experimental articles ranged from 5.2% to 17.9% of the global content of the journal. In the instructions to the authors, four (80%) journals presented explicit reference to the ethical principles in the conduction of studies with animals. The induced animal models represented 100% of the articles analyzed in this study. The rat was the most employed animal in the analyzed articles (78.3%). The present study can contribute, supplying subsidies for adoption of future editorials policies regarding the publication of animal research papers in Brazilian Journal of Cardiovascular Surgery.

  7. Network Science Experimentation Vision

    Science.gov (United States)

    2015-09-01

    capabilities and performance of a heterogeneous collection of interdependent networks . This report outlines and discusses an experimentation vision that...has been shown to depend upon the capabilities and performance of a heterogeneous collection of interdependent networks . Such a collection of networks ...well as tactical military networks . In particular, wireless tactical networks can be simulated with high fidelity, using off the shelf simulation

  8. Semiconductor Research Experimental Techniques

    CERN Document Server

    Balkan, Naci

    2012-01-01

    The book describes the fundamentals, latest developments and use of key experimental techniques for semiconductor research. It explains the application potential of various analytical methods and discusses the opportunities to apply particular analytical techniques to study novel semiconductor compounds, such as dilute nitride alloys. The emphasis is on the technique rather than on the particular system studied.

  9. Experimental modal analysis

    DEFF Research Database (Denmark)

    Ibsen, Lars Bo; Liingaard, Morten

    This technical report concerns the basic theory and principles for experimental modal analysis. The sections within the report are: Output-only modal analysis software (section 1.1), general digital analysis (section 1.2), basics of structural dynamics and modal analysis (section 1.3) and system...

  10. Strategic Experimentation : A Revision

    NARCIS (Netherlands)

    Bolton, P.; Harris, C.

    1996-01-01

    This paper extends the classic two-armed bandit problem to a many-agent setting in which I players each face the same experi- mentation problem.The main change from the single-agent prob- lem is that an agent can now learn from the current experimentation of other agents.Information is therefore a

  11. Experimental Medicine in Psychiatry New Approaches in Schizophrenia, Depression and Cognition.

    Science.gov (United States)

    Dawson, Gerard R

    The use of experimental medicine studies to bridge the gap between Phase 1 and 2 drug trials and so to enhance translation of basic neuroscience studies using experimental animals to the clinic is proposed. Illustrative examples are provided for affective disorders and schizophrenia in relation also to cognitive dysfunction.

  12. Outdoor Biology Instructional Strategies Trial Edition. Set III.

    Science.gov (United States)

    Fairwell, Kay, Ed.; And Others

    The predominant focus of the 24 Outdoor Biology Instructional Strategies (OBIS) Trial Edition Set III activities is on animal behavior, and the adaptations and diversity of both plants and animals. Night time activities, games, investigation, experimentation, and crafts are used to study ants, birds, clams, water snails, water striders, spiders,…

  13. A field vaccine trial in Tanzania demonstrates partial protection ...

    African Journals Online (AJOL)

    This study demonstrated a baseline level of MCF-seropositivity among cattle in northern Tanzania of 1% and showed that AlHV-1 virus-neutralizing antibodies could be induced in Tanzanian zebu shorthorn cross cattle by our attenuated vaccine, a correlate of protection in previous experimental trials. The vaccine reduced ...

  14. Severe sepsis: are PROWESS and PROWESS-SHOCK trials comparable? A clinical and statistical heterogeneity analysis.

    Science.gov (United States)

    Kalil, Andre C; Florescu, Diana F

    2013-07-04

    Despite the same manufacturer, the same drotrecogin alfa activated dose, and the same placebo-controlled design, the negative result from the PROWESS-SHOCK trial contradicted the survival benefit observed in the PROWESS trial. We hypothesize that the different results were due to factors other than the experimental therapy and performed an analysis of the clinical heterogeneity (differences related to the trials' clinical aspects) and the statistical heterogeneity (differences related to the trials' statistical aspects) between these trials. Baseline characteristics and co-interventions were analyzed by chi-square testing and mortality was analyzed by random-effects modeling and I2. Our findings show that clinical variables presented significant heterogeneity, and that up to 90% of the mortality differences between both trials were not due to chance. These results demonstrate that PROWESS and PROWESS-SHOCK are not comparable trials due to the highly significant clinical and statistical heterogeneity. We propose a new and pragmatic solution.

  15. Adaptive clinical trial designs for simultaneous testing of matched diagnostics and therapeutics.

    Science.gov (United States)

    Scher, Howard I; Nasso, Shelley Fuld; Rubin, Eric H; Simon, Richard

    2011-11-01

    A critical challenge in the development of new molecularly targeted anticancer drugs is the identification of predictive biomarkers and the concurrent development of diagnostics for these biomarkers. Developing matched diagnostics and therapeutics will require new clinical trial designs and methods of data analysis. The use of adaptive design in phase III trials may offer new opportunities for matched diagnosis and treatment because the size of the trial can allow for subpopulation analysis. We present an adaptive phase III trial design that can identify a suitable target population during the early course of the trial, enabling the efficacy of an experimental therapeutic to be evaluated within the target population as a later part of the same trial. The use of such an adaptive approach to clinical trial design has the potential to greatly improve the field of oncology and facilitate the development of personalized medicine. ©2011 AACR

  16. GOST: A generic ordinal sequential trial design for a treatment trial in an emerging pandemic.

    Science.gov (United States)

    Whitehead, John; Horby, Peter

    2017-03-01

    Conducting clinical trials to assess experimental treatments for potentially pandemic infectious diseases is challenging. Since many outbreaks of infectious diseases last only six to eight weeks, there is a need for trial designs that can be implemented rapidly in the face of uncertainty. Outbreaks are sudden and unpredictable and so it is essential that as much planning as possible takes place in advance. Statistical aspects of such trial designs should be evaluated and discussed in readiness for implementation. This paper proposes a generic ordinal sequential trial design (GOST) for a randomised clinical trial comparing an experimental treatment for an emerging infectious disease with standard care. The design is intended as an off-the-shelf, ready-to-use robust and flexible option. The primary endpoint is a categorisation of patient outcome according to an ordinal scale. A sequential approach is adopted, stopping as soon as it is clear that the experimental treatment has an advantage or that sufficient advantage is unlikely to be detected. The properties of the design are evaluated using large-sample theory and verified for moderate sized samples using simulation. The trial is powered to detect a generic clinically relevant difference: namely an odds ratio of 2 for better rather than worse outcomes. Total sample sizes (across both treatments) of between 150 and 300 patients prove to be adequate in many cases, but the precise value depends on both the magnitude of the treatment advantage and the nature of the ordinal scale. An advantage of the approach is that any erroneous assumptions made at the design stage about the proportion of patients falling into each outcome category have little effect on the error probabilities of the study, although they can lead to inaccurate forecasts of sample size. It is important and feasible to pre-determine many of the statistical aspects of an efficient trial design in advance of a disease outbreak. The design can then be

  17. The CYTONOX trial

    DEFF Research Database (Denmark)

    Gade, Christina; Mikus, Gerd; Christensen, Hanne Rolighed

    2016-01-01

    INTRODUCTION: In Denmark, it is estimated that 3-5% of children are obese. Obesity is associated with pathophysiological alterations that may lead to alterations in the pharmacokinetics of drugs. In adults, obesity was found to influence important drug-metabolising enzyme pathways. The impact...... of obesity-related alterations on drug metabolism and its consequences for drug dosing remains largely unknown in both children and adults. An altered drug metabolism may contribute significantly to therapeutic failure or toxicity. The aim of this trial is to investigate the in vivo activity of CYP3A4, CYP2E......1 and CYP1A2 substrates in obese versus non-obese children. METHODS: The CYTONOX trial is an open-label explorative pharmacokinetic trial. We intend to include 50 obese and 50 non-obese children. The primary end points are: in vivo clearance of CYP3A4, CYP2E1 and CYP1A2 substrates, which...

  18. Is workflow technology suitable to represent and manage clinical trials?

    Science.gov (United States)

    Fazi, P; Grifoni, P; Luzi, D; Ricci, F L; Vignetti, M

    2000-01-01

    The clinical trial has to be rigidly followed because it identifies a uniform clinical behaviour, which has to be adopted by the different physicians carrying out the test. The life cycle of the clinical trial is therefore based on a planning and definition phase, a next experimental phase connected with its diffusion to the involved centres and finally an evaluation phase of the results. An information system, which supports the users in the different phases of the clinical trial life cycle, has to take into account the different characteristics of each phase. The aim of this paper is to illustrate the role of WF technology as a component of an information system which supports the life cycle of a clinical trial also on the basis of the experience of the Italian Group for Haematological Disease of Adults (GIMEMA).

  19. TOP2017 Experimental summary

    CERN Document Server

    Giammanco, Andrea

    2017-01-01

    Thanks to the unprecedentedly fast accumulation of high-energy data at the LHC during the ongoing Run~2, most of the traditional top-quark analyses are experiencing the luxury of having to worry about how to punch through the ``Systematics Wall'', and think about new ways to maximize the utility of their data. New processes involving top quarks are being studied for the first time, and the good old pair-production processes are being explored in unusual settings, such as collisions involving heavy ions, or ``reference data'' collected by the LHC at relatively low centre-of-mass energy. The TOP2017 conference featured 37 talks delivered by experimental physicists, including seven in the ``Young Scientists Forum'' where young colleagues were given the opportunity to elaborate more deeply than usual on their own work. As it is impossible to do justice to all the experimental resu...

  20. Experimental Design Research

    DEFF Research Database (Denmark)

    This book presents a new, multidisciplinary perspective on and paradigm for integrative experimental design research. It addresses various perspectives on methods, analysis and overall research approach, and how they can be synthesized to advance understanding of design. It explores the foundations...... of experimental approaches and their utility in this domain, and brings together analytical approaches to promote an integrated understanding. The book also investigates where these approaches lead to and how they link design research more fully with other disciplines (e.g. psychology, cognition, sociology......, computer science, management). Above all, the book emphasizes the integrative nature of design research in terms of the methods, theories, and units of study—from the individual to the organizational level. Although this approach offers many advantages, it has inherently led to a situation in current...

  1. Experimental Animal Welfare

    Directory of Open Access Journals (Sweden)

    Yusuf Ergun

    2011-02-01

    Full Text Available It is an obvious obligation for investigators to consume millions of experimental animals every year to obtain scientific data. Because most of these experiments involve painful and distressing procedures, to obey the so-called 3Rs, reduction, refinement and replacement, is a prerequisite for those who would apply to ethics committees for a given research proposal. Of the 3Rs, refinement could be defined as “decrease in the incidence of severity of inhumane procedures applied to those animals, which have to be used”. In this context, animal welfare and well-being have been referred to the concept of refinement. In the present review, general principles relating to experimental animal welfare will be discussed. [Archives Medical Review Journal 2011; 20(1.000: -

  2. The CMS experimental cavern

    CERN Multimedia

    Maximilien Brice

    2005-01-01

    These images taken in early September 2005 show the cathedral-like cavern into which the CMS experiment will be installed. The 26X26X60 cubic metre hall is the largest underground cavern at CERN, located under the town of Cessy in France. Weighing 12 500 tonnes, the huge CMS detector will be assembled in a specially constructed hall above ground before being lowered into the experimental hall ready for the LHC start-up in 2008.

  3. The Massabesic Experimental Forest

    Science.gov (United States)

    Thomas W. McConkey; Wendell E. Smith

    1958-01-01

    White pine and fire! These two - the tree and its destroyer, fire - are keys to the history and present make-up of the research program on the Massabesic Experimental Forest at Alfred, Maine. The Forest was established in the late 1930's to study the management of eastern white pine. During World War II, it was shut down, and reopened again in 1946. Then, in 1947...

  4. Ingratiation: Experimental Evidence

    OpenAIRE

    Robin, Stéphane; Rusinowska, Agnieszka; Villeval, Marie Claire

    2014-01-01

    We investigate experimentally ingratiatory behavior expressed by opinion conformity. Both individuals' performance at a task and their opinions on various topics can be observed before unequal payoffs are assigned by a second mover. In some treatments, first movers can change their opinion after learning that held by the second mover. We find evidence of high ingratiation indices, as opinion conformity is rewarded. However, second movers reward conformity less when it is common knowledge that...

  5. Methods of experimental physics

    CERN Document Server

    Williams, Dudley

    1962-01-01

    Methods of Experimental Physics, Volume 3: Molecular Physics focuses on molecular theory, spectroscopy, resonance, molecular beams, and electric and thermodynamic properties. The manuscript first considers the origins of molecular theory, molecular physics, and molecular spectroscopy, as well as microwave spectroscopy, electronic spectra, and Raman effect. The text then ponders on diffraction methods of molecular structure determination and resonance studies. Topics include techniques of electron, neutron, and x-ray diffraction and nuclear magnetic, nuclear quadropole, and electron spin reson

  6. The CYTONOX trial

    DEFF Research Database (Denmark)

    Gade, Christina; Mikus, Gerd; Christensen, Hanne Rolighed

    2016-01-01

    of obesity-related alterations on drug metabolism and its consequences for drug dosing remains largely unknown in both children and adults. An altered drug metabolism may contribute significantly to therapeutic failure or toxicity. The aim of this trial is to investigate the in vivo activity of CYP3A4, CYP2E...... will be defined by using well-tested probes; midazolam, chlorzoxazone and caffeine. Each of the probes will be administered as a single dose. Subsequently, blood and urine samples will be collected at pre-specified times. CONCLUSION: The aim of the CYTONOX trial is to investigate the in vivo activity of CYP3A4...

  7. Reporting Quality of Social and Psychological Intervention Trials: A Systematic Review of Reporting Guidelines and Trial Publications

    Science.gov (United States)

    Grant, Sean P.; Mayo-Wilson, Evan; Melendez-Torres, G. J.; Montgomery, Paul

    2013-01-01

    Background Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. Objective/Design We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials. Data Sources (1) To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2) To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. Eligibility (1) Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2) Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. Results (1) We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2) Our review of trials (n = 239) revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information) and abstracts (55%); information about blinding (15%), sequence generation (23%), and allocation concealment (17%); and details about actual delivery of experimental (43%) and control interventions (34%), participant uptake (25%), and service environment (28%). Only 11 of 40 journals referenced reporting guidelines in “Instructions to Authors.” Conclusion Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely

  8. Reporting quality of social and psychological intervention trials: a systematic review of reporting guidelines and trial publications.

    Science.gov (United States)

    Grant, Sean P; Mayo-Wilson, Evan; Melendez-Torres, G J; Montgomery, Paul

    2013-01-01

    Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials. (1) To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2) To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. ELIGIBILITY: (1) Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2) Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. (1) We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2) Our review of trials (n = 239) revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information) and abstracts (55%); information about blinding (15%), sequence generation (23%), and allocation concealment (17%); and details about actual delivery of experimental (43%) and control interventions (34%), participant uptake (25%), and service environment (28%). Only 11 of 40 journals referenced reporting guidelines in "Instructions to Authors." Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely missing from trial publications; most leading journals in social and

  9. 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

  10. The ONTARGET trial programme

    DEFF Research Database (Denmark)

    Unger, Thomas; Kintscher, Ulrich; Kappert, Kai

    2009-01-01

    The ONTARGET trial programme tested the effects of the angiotensin AT1 receptor blocker (ARB), telmisartan, alone or in combination with the angiotensin converting enzyme (ACE) inhibitor, ramipril, in more than 25.000 patients at high cardiovascular risk including diabetes on a combined endpoint...

  11. Statistically Valid Planting Trials

    Science.gov (United States)

    C. B. Briscoe

    1961-01-01

    More than 100 million tree seedlings are planted each year in Latin America, and at least ten time'that many should be planted Rational control and development of a program of such magnitude require establishing and interpreting carefully planned trial plantings which will yield statistically valid answers to real and important questions. Unfortunately, many...

  12. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...

  13. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

    Østervig, R M; Sonne, A; Rasmussen, L S

    2015-01-01

    starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...... the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... registered when it could be verified that patient enrolment was started after registration in a trial registry. RESULTS: We identified 200 RCTs. Dates for patient enrolment were not specified in 51 (25.5%). The proportion of correctly registered trials increased significantly from 17.1% (19/111) for trials...

  14. Informed consent in experimentation involving mentally impaired persons: ethical issues

    Directory of Open Access Journals (Sweden)

    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.

  15. Trial in absentia

    Directory of Open Access Journals (Sweden)

    Knežević Saša

    2014-01-01

    Full Text Available The active participation of parties and other procedural subjects in trial proceedings is essential for the exercise of the principle of immediacy. The presence of parties and other subjects in the presentation of evidence is essential in the process of fact-finding and deciding on the admissibility of evidence, either by hearing testimonies or examining the presented material evidence. The international instruments on human rights' protection promote the right of the defendant to participate in the proceedings involving charges raised against him/her. Although the defendant's testimony is primarily used as a tool for the effective operation of the defense, legislations do not refute this highly important source of evidence. The defendant's presence in trial is highly important for the exercise of the immediacy principle and other basic procedural principles. The process of determining the factual grounds is further aggravated if the parties are not present in court proceedings. Consequently, legislations provide a wide range of measures to ensure the defendant's presence in criminal proceedings. The Serbian Criminal Procedure Act provides the instruments for securing the presence of parties in criminal proceedings. It is particularly important to ensure the presence of the defendant in the central stage of the criminal proceedings. Yet, there are sometimes significant criminal and political reasons for the defendant to be tried in absentia, which implies a divergence from some important procedural principles. The presentation of evidence and fact-finding may ensue even without the defendant's physical presence in the proceedings in case of the defendant's default (failure to appear] in summary proceedings and in case where the defendant is a fugitive from justice or unavailable to public authorities (either in summary or in regular trial proceedings]. Trial in absentia is not allowed in trials involving minors.

  16. Models of experimental epilepsy

    Directory of Open Access Journals (Sweden)

    Fatih Ekici

    2011-03-01

    Full Text Available Epilepsy is the most common serious neurological conditionin the world, with an estimated prevalence of 1% ofthe population. A large number of experimental modelsof seizure and epilepsy have been developed. These experimentalmodels are elicited by chemical convulsants,electrical stimulation, genetic models, structural lesions,physical stimuli (cold, pressure, hyperthermia, electricalin animals. Well-characterized animal models may allowthe understanding of the basic mechanisms underlyingepileptogenesis (it refers to the alteration of a normalneuronal network into a hyperexcitable network in whichrecurrent, spontaneous seizures occur. Moreover, thesemodels might also prove useful in identifying novel therapeuticapproaches to treatment of epilepsy. J Clin ExpInvest 2011; 2(1: 118-123

  17. Experimental Axion Review

    CERN Multimedia

    CERN. Geneva

    2016-01-01

    Axions are a natural consequence of the Peccei-Quinn mechanism, the most compelling solution to the strong-CP problem. Similar axion-like particles (ALPs) also appear in a number of possible extensions of the Standard Model, notably in string theories. Both axions and ALPs are very well motivated candidates for the Dark Matter, and in addition would be copiously produced at the stellar cores. Some anomalous astrophysical observations could be hinting the existence of these particles. They are object of increasing interest by experimentalists. I will briefly review the motivation to search for axions and ALPs, as well as the current status and future prospects of the experimental landscape.

  18. Outsourcing of experimental work.

    Science.gov (United States)

    Nielsen, Henrik

    2011-01-01

    With the development of new technologies for simultaneous analysis of many genes, transcripts, or proteins (the "omics" revolution), it has become common to outsource parts of the experimental work. In order to maintain the integrity of the research projects, it is important that the interphase between the researcher and the service is further developed. This involves robust protocols for sample preparation, an informed choice of analytical tool, development of standards for individual technologies, and transparent data analysis. This chapter introduces some of the problems related to analysis of RNA samples in the "omics" context and gives a few hints and key references related to sample preparation for the non-specialist.

  19. Experimental Blade Research

    DEFF Research Database (Denmark)

    Eder, Martin Alexander; Branner, Kim; Berring, Peter

    This report is a summary of the results obtained in the project: Experimental Blade Research – phase 2 (EBR2). The project was supported by the Danish Energy Authority through the 2010 Energy Technology Development and Demonstration Program (EUDP 2010-II) and has journal no. 64011-0006. The project...... has been running from spring 2011 to the end of 2014. Being a summary report, this report only contains a collection of the research topics and the major results. For more details, see the publications listed at the end of this report....

  20. Embryo manipulation and experimentation.

    Science.gov (United States)

    Warren, M A

    1991-09-01

    I have argued that early human embryos are not human beings, and do not have normal rights. Like human sperm and ova, they are both alive and biologically human. However, they lack the physiological development necessary to sustain a capacity for sentience. If Ford is right, then they are not yet individual human organisms. But the more important point is that their lack of a capacity for sentience makes them inappropriate candidates for the ascription of moral rights. Thus, research on human embryos produced in vitro is not a wrong against them--at least so long as experimentally manipulated embryos are not returned to the womb, or artificially gestated to a stage at which they might become sentient. Some of the more difficult issues about embryo experimentation involve the rights of women as experimental subject and donors. The consent of both male and female gamete donors should normally be required for the production or experimental use of IVF embryos. (Possible exceptions might include cases in which one or both progenitors have died, and the survivor or other responsible family member wished to donate the (frozen) IVF embryos for research or other uses.) However, it is women's rights that are most apt to be endangered, for example, if the large scale therapeutic or commercial use of human embryos leads to a demand for large numbers of ova. Thus, it is vital that researchers and policy-makers heed feminist concerns about embryo research and the new biomedical technologies it may yield. Given adequate information and appropriate procedural protections, women are capable of making autonomous decisions about donating ova or embryos for biomedical research. But regulatory safeguards are needed to ensure against their being coerced, deceived, or manipulated into becoming ovum or embryo donors. As Daniel Callahan has detailed, biomedical technology has reached the point where we can no longer afford to provide everyone with all of the innovative therapies that might

  1. 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.

  2. Street Law Mock Trial Manual.

    Science.gov (United States)

    McGuire, Patricia, Ed.; O'Brien, Edward L.; Arbetman, Lee; Mills, Vivian H.; Pannell, Andrew

    Designed to facilitate the expanded use of mock trials, this manual is divided into two principle sections--a teacher's guide and a student's guide. The teacher's guide contains specific advice to teachers on all aspects of preparing for a mock trial and seven specific lesson plans for a 2- to 3-week mock trial unit. Each lesson contains…

  3. The Trial of Katherine Harrison.

    Science.gov (United States)

    Woodward, Walter W.

    2003-01-01

    Presents a lesson plan in which the teacher and students participate in a mock trial of Katherine Harrison, who was accused of witchcraft in the seventeenth century. Provides background information about the trial, as well as primary sources of the testimonies given by witnesses during the trial. (CMK)

  4. [Animal experimentation in Israel].

    Science.gov (United States)

    Epstein, Yoram; Leshem, Micah

    2002-04-01

    In 1994 the Israeli parliament (Knesset) amended the Cruelty to Animals Act to regulate the use of experimental animals. Accordingly, animal experiments can only be carried out for the purposes of promoting health and medical science, reducing suffering, advancing scientific research, testing or production of materials and products (excluding cosmetics and cleaning products) and education. Animal experiments are only permitted if alternative methods are not possible. The National Board for Animal Experimentation was established to implement the law. Its members are drawn from government ministries, representatives of doctors, veterinarians, and industry organizations, animal rights groups, and academia. In order to carry out an animal experiment, the institution, researchers involved, and the specific experiment, all require approval by the Board. To date the Board has approved some 35 institutions, about half are public institutions (universities, hospitals and colleges) and the rest industrial firms in biotechnology and pharmaceutics. In 2000, 250,000 animals were used in research, 85% were rodents, 11% fowls, 1,000 other farm animals, 350 dogs and cats, and 39 monkeys. Academic institutions used 74% of the animals and industry the remainder. We also present summarized data on the use of animals in research in other countries.

  5. Whither Experimental Semantics?

    Directory of Open Access Journals (Sweden)

    Michael Devitt

    2012-01-01

    Full Text Available The main goal of the paper is to propose a methodology for the theory of reference in which experiments feature prominently. These experiments should primarily test linguistic usage rather than the folk’s referential intuitions. The proposed methodology urges the use of: (A philosophers’ referential intuitions, both informally and, occasionally, scientifically gathered; (B the corpus, both informally and scientifically gathered; (C elicited production; and, occasionally, (D folk’s referential intuitions. The most novel part of this is (C and that is where most of the experimental work should be. The secondary goal of the paper is to defend my earlier paper “Experimental Semantics” from the criticisms of Machery, Mallon, Nichols, and Stich in “If Folk Intuitions Vary, Then What?” They charge that I have seriously misunderstood their goal in “Semantics, Cross-Cultural Style” and that many of my arguments are “largely irrelevant”. I argue that these charges are baseless.

  6. Inflammatory pain in experimental burns in man

    DEFF Research Database (Denmark)

    Pedersen, J L

    2000-01-01

    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......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...... is an example of such a model, and several groups have performed studies of analgesics and pain mechanisms based on the model. The thesis aims to provide a critical review of the human burn model as a tool in pain research, and to give suggestions for development of the model and future research. The pain...

  7. Funding oncology clinical trials: are cooperative group trials sustainable?

    Science.gov (United States)

    Seow, Hsien-Yeang; Whelan, Patrick; Levine, Mark N; Cowan, Kathryn; Lysakowski, Barbara; Kowaleski, Brenda; Snider, Anne; Xu, Rebecca Y; Arnold, Andrew

    2012-05-01

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

  8. Lipid metabolism in experimental animals

    Directory of Open Access Journals (Sweden)

    Sánchez-Muñiz, Francisco J.

    1998-08-01

    Full Text Available Publications are scarce in the way in chich metabolic processes are affected by the ingestion of heated fats used to prepare food. Similarly studies measuring metabolic effects of the consumption on fried food are poorly known. The purpose of this presentation is to summarize information on frying fats and frying foods upon lipid metabolism in experimental animals. Food consumption is equivalent or even higher when oils or the fat content of frying foods are poorly alterated decreasing their acceptability when their alteration degree increase. After 4hr. experiment the digestibility and absorption coefficients of a single dosis of thermooxidized oils were significantly decreased in rats, however the digestive utilization of frying thermooxidized oils included in diets showed very little change in comparison with unused oils by feeding trials on rats. Feeding rats different frying fats induced a slight hypercholesterolemic effect being the magnitude of this effect related to the linoleic decrease in diet produced by frying. However HDL, the main rat-cholesterol carrier, also increased, thus the serum cholesterol/HDL-cholesterol ratio did not change. Results suggest that rats fed frying fats adapt their lipoprotein metabolism increasing the number of HDL particles. Deep fat frying deeply changed the fatty acid composition of foods, being possible to increase their n-9 or n-6 fatty acid and to decrease the saturated fatty acid contents by frying. When olive oil-and sunflower oil-fried sardines were used as the only protein and fat sources of rats-diets in order to prevent the dietary hypercholesterolemia it was provided that both fried-sardine diets showed a powerful check effect on the cholesterol raising effect induced by dietary cholesterol. The negative effect of feeding rats cholesterol plus bovine bile to induce hypercholesterolemia on some cell-damage markers such as lactate dehydrogenase, transaminases, alkaline phosphatase, was

  9. Evaluation of a nurse mentoring intervention to family caregivers in the management of delirium after cardiac surgery (MENTOR_D): a study protocol for a randomized controlled pilot trial

    National Research Council Canada - National Science Library

    Mailhot, Tanya; Cossette, Sylvie; Bourbonnais, Anne; Côté, José; Denault, André; Côté, Marie-Claude; Lamarche, Yoan; Guertin, Marie-Claude

    2014-01-01

    .... Therefore, this randomized pilot trial examines the acceptability, feasibility, and preliminary efficacy of an experimental nursing intervention to help family caregivers manage post-cardiac surgery...

  10. Experimental techniques; Techniques experimentales

    Energy Technology Data Exchange (ETDEWEB)

    Roussel-Chomaz, P. [GANIL CNRS/IN2P3, CEA/DSM, 14 - Caen (France)

    2007-07-01

    This lecture presents the experimental techniques, developed in the last 10 or 15 years, in order to perform a new class of experiments with exotic nuclei, where the reactions induced by these nuclei allow to get information on their structure. A brief review of the secondary beams production methods will be given, with some examples of facilities in operation or under project. The important developments performed recently on cryogenic targets will be presented. The different detection systems will be reviewed, both the beam detectors before the targets, and the many kind of detectors necessary to detect all outgoing particles after the reaction: magnetic spectrometer for the heavy fragment, detection systems for the target recoil nucleus, {gamma} detectors. Finally, several typical examples of experiments will be detailed, in order to illustrate the use of each detector either alone, or in coincidence with others. (author)

  11. Experimental Multiport Bicone Antenna

    Science.gov (United States)

    Eskelinen, Pekka; Ylinen, Juhana

    2013-01-01

    A practical, easily manufactured multiport bicone antenna suitable for many receiving tasks such as direction finding systems can be made by using sharp-edged metal fins on the feeding coax center conductor to provide a tapered transition and connection path to coaxial probes. This construction resembles an arrow's tail. Already four mutually orthogonal fins can give full 360 degree azimuth coverage with suitable -3 dB port pattern overlap. Five experimental constructions working at Ku and Ka bands, each with fractional bandwidths of 23 to 31 per cent, are shown with full dimensional details. Suitable fin tapering is close to the full air gap in the coax and fin thickness should be less than 1/16th of the outer conductor diameter.

  12. Management an experimental approach.

    Science.gov (United States)

    Reed, J C; Aspy, V H

    1978-06-01

    An experimental teaching procedure was devised and tested for integrating the nursing process, nursing care plans, the research process and management principals. The integration defined as the problem oriented process (POP) was tested with 16 students over two semesters. The results indicated that the POP was a successful integration that aided the student in "getting it all together." As one of the students put it: This experience will give future students, as it did me, a better understanding of how research is best utilized. The students can use almost all their past learning experiences, bringing it all together in one situation. He (the student) can use his communication skills to detect a problem, his research skills to design planned intervention and evaluation and his interpersonal skills to measure his effectiveness as a change agent. Finally, he can use his nursing skills and knowledge of pathophysiology in a setting most like what he will find upon graduation.

  13. The FOCUS trial

    DEFF Research Database (Denmark)

    Glenthøj, Louise B; Fagerlund, Birgitte; Randers, Lasse

    2015-01-01

    of the cognitive training to their everyday lives. Follow-up assessments will be conducted at 6 and 12 months after randomisation. The primary outcome is the composite score on the Brief Assessment of Cognition in Schizophrenia at cessation of treatment after 6 months. Secondary outcomes are social and daily...... versus standard treatment. The cognitive remediation consists of 24 weekly group-based and manualised sessions targeting neurocognition and social cognition. In addition to the group sessions, the patients will be offered 12 individual sessions aiming at maximising the transfer of the effects......: This is the first trial to evaluate the effects of neurocognitive and social cognitive remediation in UHR patients. The FOCUS trial results will provide evidence on the effect of targeted and comprehensive cognitive rehabilitation on cognition, daily living, and symptomatology as well as long-term outcome...

  14. The SafeBoosC II randomized trial

    DEFF Research Database (Denmark)

    Plomgaard, Anne M; van Oeveren, Wim; Petersen, Tue Hvass

    2016-01-01

    BACKGROUND: The SafeBoosC phase II multicentre randomized clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline vs. no NIRS data and treatment as usual in the control group...... during the first 72 h of life. The trial demonstrated a significant reduction in the burden of cerebral hypoxia in the experimental group. We now report the blindly assessed and analyzed treatment effects on electroencephalographic (EEG) outcomes (burst rate and spectral edge frequency 95% (SEF95...

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

    Science.gov (United States)

    Christopher, Paul P; Appelbaum, Paul S; Truong, Debbie; Albert, Karen; Maranda, Louise; Lidz, Charles

    2017-01-01

    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

  16. Design and analysis issues for economic analysis alongside clinical trials.

    Science.gov (United States)

    Marshall, Deborah A; Hux, Margaret

    2009-07-01

    Clinical trials can offer a valuable and efficient opportunity to collect the health resource use and outcomes data for economic evaluation. However, economic and clinical studies differ fundamentally in the question they seek to answer. The design and analysis of trial-based cost-effectiveness studies require special consideration, which are reviewed in this article. Traditional randomized controlled trials, using an experimental design with a controlled protocol, are designed to measure safety and efficacy for product registration. Cost-effectiveness analysis seeks to measure effectiveness in the context of routine clinical practice, and requires collection of health care resources to allow estimation of cost over an equal timeframe for each treatment alternative. In assessing suitability of a trial for economic data collection, the comparator treatment and other protocol factors need to reflect current clinical practice and the trial follow-up must be sufficiently long to capture important costs and effects. The broadest available population and a measure of effectiveness reflecting important benefits for patients are preferred for economic analyses. Special analytical issues include dealing with missing and censored cost data, assessing uncertainty of the incremental cost-effectiveness ratio, and accounting for the underlying heterogeneity in patient subgroups. Careful consideration also needs to be given to data from multinational studies since practice patterns can differ across countries. Although clinical trials can be an efficient opportunity to collect data for economic evaluation, careful consideration of the suitability of the study design, and appropriate analytical methods must be applied to obtain rigorous results.

  17. Efficacy of the Olyset Duo net against insecticide-resistant mosquito vectors of malaria.

    Science.gov (United States)

    Ngufor, Corine; N'Guessan, Raphael; Fagbohoun, Josias; Todjinou, Damien; Odjo, Abibath; Malone, David; Ismail, Hanafy; Akogbeto, Martin; Rowland, Mark

    2016-09-14

    Olyset Duo is a new long-lasting insecticidal net treated with permethrin (a pyrethroid) and pyriproxyfen, an insect growth regulator that disrupts the maturation of oocytes in mosquitoes exposed to the net. We tested the Olyset Duo net against pyrethroid-resistant Anopheles gambiae mosquitoes, which transmit malaria parasites, in laboratory bioassays and in a trial in Benin using experimental huts that closely resemble local habitations. Host-seeking mosquitoes that entered to feed were free to contact the occupied nets and were collected the next morning from exit traps. Surviving blood-fed mosquitoes were observed for effects on reproduction. Control nets were treated with pyrethroid only or pyriproxyfen only, and nets were tested unwashed and after 20 standardized washes. The Olyset Duo net showed improved efficacy and wash resistance relative to the pyrethroid-treated net in terms of mosquito mortality and prevention of blood feeding. The production of offspring among surviving blood-fed A. gambiae in the hut trial was reduced by the pyriproxyfen-treated net and the Olyset Duo net both before washing (90 and 71% reduction, respectively) and after washing (38 and 43% reduction, respectively). The degree of reproductive suppression in the hut trial was predicted by laboratory tunnel tests but not by cone bioassays. The overall reduction in reproductive rate of A. gambiae with the Olyset Duo net in the trial was 94% with no washing and 78% after 20 washes. The Olyset Duo net has the potential to provide community control of mosquito populations and reduce malaria transmission in areas of high insecticide resistance. Copyright © 2016, American Association for the Advancement of Science.

  18. 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.

  19. Experimental Particle Physics

    Energy Technology Data Exchange (ETDEWEB)

    Rosenfeld, Carl [Univ of South Carolina; Mishra, Sanjib R. [Univ of South Carolina; Petti, Roberto [Univ of South Carolina; Purohit, Milind V. [Univ of South Carolina

    2014-08-31

    The high energy physics group at the University of South Carolina, under the leadership of Profs. S.R. Mishra, R. Petti, M.V. Purohit, J.R. Wilson (co-PI's), and C. Rosenfeld (PI), engaged in studies in "Experimental Particle Physics." The group collaborated with similar groups at other universities and at national laboratories to conduct experimental studies of elementary particle properties. We utilized the particle accelerators at the Fermi National Accelerator Laboratory (Fermilab) in Illinois, the Stanford Linear Accelerator Center (SLAC) in California, and the European Center for Nuclear Research (CERN) in Switzerland. Mishra, Rosenfeld, and Petti worked predominantly on neutrino experiments. Experiments conducted in the last fifteen years that used cosmic rays and the core of the sun as a source of neutrinos showed conclusively that, contrary to the former conventional wisdom, the "flavor" of a neutrino is not immutable. A neutrino of flavor "e," "mu," or "tau," as determined from its provenance, may swap its identity with one of the other flavors -- in our jargon, they "oscillate." The oscillation phenomenon is extraordinarily difficult to study because neutrino interactions with our instruments are exceedingly rare -- they travel through the earth mostly unimpeded -- and because they must travel great distances before a substantial proportion have made the identity swap. Three of the experiments that we worked on, MINOS, NOvA, and LBNE utilize a beam of neutrinos from an accelerator at Fermilab to determine the parameters governing the oscillation. Two other experiments that we worked on, NOMAD and MIPP, provide measurements supportive of the oscillation experiments. Good measurements of the neutrino oscillation parameters may constitute a "low energy window" on related phenomena that are otherwise unobservable because they would occur only at energies way above the reach of conceivable accelerators. Purohit and Wilson participated in the Ba

  20. Randomised double blind placebo controlled trial of prednisolone in children admitted to hospital with respiratory syncytial virus bronchiolitis

    NARCIS (Netherlands)

    van Woensel, JBM; Wolfs, TFW; vanAalderen, WMC; Brand, PLP; Kimpen, JLL

    Background - Experimental and clinical evidence suggests that respiratory syncytial virus (RSV) bronchiolitis is an immune mediated disease. Corticosteroids might therefore be effective in the treatment of RSV bronchiolitis. Methods - A randomised double blind trial was conducted in children up to

  1. Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review.

    Science.gov (United States)

    Hunsinger, Matthew; Smith, Shannon M; Rothstein, Daniel; McKeown, Andrew; Parkhurst, Melissa; Hertz, Sharon; Katz, Nathaniel P; Lin, Allison H; McDermott, Michael P; Rappaport, Bob A; Turk, Dennis C; Dworkin, Robert H

    2014-11-01

    Assessment of treatment safety is 1 of the primary goals of clinical trials. Organizations and working groups have created reporting guidelines for adverse events (AEs). Previous research examining AE reporting for pharmacologic clinical trials of analgesics in major pain journals found many reporting inadequacies, suggesting that analgesic trials are not adhering to existing AE reporting guidelines. The present systematic review documented AE reporting in 3 main pain journals for nonpharmacologic, noninterventional (NP/NI) trials examining pain treatments. To broaden our pool of nonpharmacologic trials, we also included trials examining acupuncture, leech therapy, and noninvasive stimulation techniques (eg, transcutaneous electrical nerve stimulation). We documented AE reporting at 2 levels of specificity using coding manuals based on the Consolidated Standards of Reporting Trials (CONSORT) harms reporting standards and Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) AE reporting checklist. We identified a number of inadequacies in AE reporting across the 3 journals. For example, using the ACTTION coding manual, we found that less than one-half of the trials reported specific AE assessment methods; approximately one-third of the trials reported withdrawals due to AEs for each study arm; and about one-fourth of the trials reported all specific AEs. We also examined differences in AE reporting across several trial characteristics, finding that AE reporting was generally more detailed in trials with patients versus those using healthy volunteers undergoing experimentally evoked pain. These results suggest that investigators conducting and reporting NP/NI clinical trials are not adequately describing the assessment and occurrence of AEs. Copyright © 2014 International Association for the Study of Pain. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    S Gowri

    2017-01-01

    Conclusion: The number of clinical trials in dentistry are low in India, and more focus should be placed by dental investigators regarding the reporting standards. Furthermore, researchers and trial sponsors should aim at publication of the research findings so that it is made publically available for use. A clear-cut need exists for an increase in both the quantity and quality of clinical trials in dentistry.

  3. Experimental Neutrino Physics

    Energy Technology Data Exchange (ETDEWEB)

    Wilkes, Richard Jeffrey [Univ. of Washington, Seattle, WA (United States)

    2017-11-15

    The University of Washington (UW) HEP neutrino group performed experimental research on the physics of neutrinos, using the capabilities offered by the T2K Experiment and the Super-Kamiokande Neutrino Observatory. The UW group included senior investigator R. J. Wilkes, two PhD students, four MS degree students, and a research engineer, all of whom are members of the international scientific collaborations for T2K and Super-Kamiokande. During the period of support, within T2K we pursued new precision studies sensitive to new physics, going beyond the limits of current measurements of the fundamental neutrino oscillation parameters (mass differences and mixing angles). We began efforts to measure (or significantly determine the absence of) 1 the CP-violating phase parameter δCP and determine the neutrino mass hierarchy. Using the Super-Kamiokande (SK) detector we pursued newly increased precision in measurement of neutrino oscillation parameters with atmospheric neutrinos, and extended the current reach in searches for proton decay, in addition to running the most sensitive supernova watch instrument [Scholberg 2012], performing other astrophysical neutrino studies, and analyzing beam-induced events from T2K. Overall, the research addressed central questions in the field of particle physics. It included the training of graduate students (both PhD and professional MS degree students), and postdoctoral researchers. Undergraduate students also participated as laboratory assistants.

  4. Experimental microdosimetry; Experimentele microdosimetrie

    Energy Technology Data Exchange (ETDEWEB)

    Farahmand, M.; Bos, A.J.J.; Zoetelief, J.; Van Eijk, C.W.E. [Afdeling Stralingstechnologie, Interfacultair Reactor Instituut IRI, Technische Universiteit Delft, Delft (Netherlands)

    2001-12-01

    In the exchange between ionizing radiation and matter radiation energy is emitted in discrete portions. The discipline that studies the statistical distribution of energy deposition on a microscopic level is microdosimetry. The aim of microdosimetry is to find the correlation between the distribution of energy depositions (microdosimetry spectra) and the biological damage caused by radiation. In experimental microdosimetry use is made of a Tissue-Equivalent Proportional Counter (TEPC), the subject of this article. [Dutch] Bij wisselwerking van ioniserende straling met materie wordt de stralingsenergie afgegeven in discrete porties. Het vakgebied dat de statistische distributie van die energiedeposities op microscopisch niveau onderzoekt wordt aangeduid met microdosimetrie. Het uiteindelijke doel daarbij is om een samenhang te vinden tussen de distributie van energiedeposities (de microdosimetrische spectra) en de schade die optreedt als biologisch materiaal wordt blootgesteld aan straling. In de experimentele microdosimetrie wordt meestal gebruik gemaakt van een Tissue-Equivalent Proportional Counter (TEPC). Van microdosimetrische spectra gemeten met een TEPC blijkt dat deze gerelateerd zijn aan het effect van straling in biologisch materiaal. Ze kunnen daarom worden gebruikt voor het experimenteel bepalen van de kwaliteitsfactor van de straling.

  5. Experimental quantum data locking

    Science.gov (United States)

    Liu, Yang; Cao, Zhu; Wu, Cheng; Fukuda, Daiji; You, Lixing; Zhong, Jiaqiang; Numata, Takayuki; Chen, Sijing; Zhang, Weijun; Shi, Sheng-Cai; Lu, Chao-Yang; Wang, Zhen; Ma, Xiongfeng; Fan, Jingyun; Zhang, Qiang; Pan, Jian-Wei

    2016-08-01

    Classical correlation can be locked via quantum means: quantum data locking. With a short secret key, one can lock an exponentially large amount of information in order to make it inaccessible to unauthorized users without the key. Quantum data locking presents a resource-efficient alternative to one-time pad encryption which requires a key no shorter than the message. We report experimental demonstrations of a quantum data locking scheme originally proposed by D. P. DiVincenzo et al. [Phys. Rev. Lett. 92, 067902 (2004), 10.1103/PhysRevLett.92.067902] and a loss-tolerant scheme developed by O. Fawzi et al. [J. ACM 60, 44 (2013), 10.1145/2518131]. We observe that the unlocked amount of information is larger than the key size in both experiments, exhibiting strong violation of the incremental proportionality property of classical information theory. As an application example, we show the successful transmission of a photo over a lossy channel with quantum data (un)locking and error correction.

  6. [Animal experimentation, animal welfare and scientific research].

    Science.gov (United States)

    Tal, H

    2013-10-01

    Hundreds of thousands of laboratory animals are being used every year for scientific experiments held in Israel, mostly mice, rats, rabbits, guinea pigs, and a few sheep, cattle, pigs, cats, dogs, and even a few dozen monkeys. In addition to the animals sacrificed to promote scientific research, millions of animals slain every year for other purposes such as meat and fine leather fashion industries. While opening a front against all is an impossible and perhaps an unjustified task, the state of Israel enacted the Animal Welfare (Animal Experimentation) Law (1994). The law aims to regulate scientific animal experiments and to find the appropriate balance between the need to continue to perform animal experiments for the advancement of research and medicine, and at the same time to avoid unnecessary trials and minimize animal suffering. Among other issues the law deals with the phylogenetic scale according to which experimental animals should be selected, experiments for teaching and practicing, and experiments for the cosmetic industry. This article discusses bioethics considerations in animal experiments as well as the criticism on the scientific validity of such experiments. It further deals with the vitality of animal studies and the moral and legal obligation to prevent suffering from laboratory animals.

  7. An Experimental Study of Soft Lubrication

    Science.gov (United States)

    Wu, Qianhong; Gacka, Thomas; Nathan, Rungun; Wu, Li-Zhu; Cbmss Team

    2012-11-01

    Lift generation in soft porous media, as a planing surface glides over it, is a new topic in porous media flow with superior potential for lubrication and squeeze damping. This paper presents the first experimental study of this phenomenon. The experimental setup consists of a running conveyer belt covered with a soft porous sheet, and a stationary instrumented inclined planar upper board. Twelve pressure transducers mounted on the upper board captured the pore pressure generation, while a load cell was used to capture the total lifting force, arising from both the pore pressure and the compression of the solid fibers. One finds that the pore pressure distribution is consistent with theoretical predictions (Feng and Weinbaum, JFM, 2000; Wu et al., MSSE, 2006, 2011), and depends on the running belt velocity, U, the mechanical properties of the porous material, and the compression ratios of the porous layer. For a typical trial (h2/h1=5,h2/h0=1, U=3.8 m/s, where h2, h1, and h0 are the leading edge, trailing edge, and undeformed porous layer thicknesses, respectively), 68% of the lifting force was generated by the pore pressure. It conclusively demonstrates the validity of using soft porous materials for super lubrication. applications. Villanova Cellular Biomechanics and Sports Science Laboratory.

  8. 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.

  9. Associations between psychological variables and pain in experimental pain models. A systematic review

    DEFF Research Database (Denmark)

    Hansen, M S; Horjales-Araujo, E; Dahl, J B

    2015-01-01

    are predictive of the level of pain following experimental pain models. METHODS: A systematic search on the databases, PubMed, Embase, Cochcrane library, and Clinicaltrials.gov was performed during September 2014. All trials investigating the association between psychological variables and experimental pain...... and experimental pain. CONCLUSION: Psychological factors may have predictive value when investigating experimental pain. However, due to substantial heterogeneity and methodological shortcomings of the published literature, firm conclusions are not possible.......BACKGROUND: The association between pain and psychological characteristics has been widely debated. Thus, it remains unclear whether an individual's psychological profile influences a particular pain experience, or if previous pain experience contributes to a certain psychological profile...

  10. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998......-blinding. The median quality score of all trials was 3 points (range, 1-5 points). Multiple logistic regression analysis explored the association between quality and therapeutic areas, number of centers, external funding, year of publication, and country of origin. High-quality trials were most likely to investigate......, single-center trials, and trials with no external funding. Quality did not improve with time and was not associated with country of origin. The main conclusions are that the quality of RCTs in HEPATOLOGY needs improvement and that the probability of high quality increased with the number of centers...

  11. Experimental thermodynamics experimental thermodynamics of non-reacting fluids

    CERN Document Server

    Neindre, B Le

    2013-01-01

    Experimental Thermodynamics, Volume II: Experimental Thermodynamics of Non-reacting Fluids focuses on experimental methods and procedures in the study of thermophysical properties of fluids. The selection first offers information on methods used in measuring thermodynamic properties and tests, including physical quantities and symbols for physical quantities, thermodynamic definitions, and definition of activities and related quantities. The text also describes reference materials for thermometric fixed points, temperature measurement under pressures, and pressure measurements. The publicatio

  12. Taguchi method of experimental design in materials education

    Science.gov (United States)

    Weiser, Martin W.

    1993-01-01

    Some of the advantages and disadvantages of the Taguchi Method of experimental design as applied to Materials Science will be discussed. This is a fractional factorial method that employs the minimum number of experimental trials for the information obtained. The analysis is also very simple to use and teach, which is quite advantageous in the classroom. In addition, the Taguchi loss function can be easily incorporated to emphasize that improvements in reproducibility are often at least as important as optimization of the response. The disadvantages of the Taguchi Method include the fact that factor interactions are normally not accounted for, there are zero degrees of freedom if all of the possible factors are used, and randomization is normally not used to prevent environmental biasing. In spite of these disadvantages it is felt that the Taguchi Method is extremely useful for both teaching experimental design and as a research tool, as will be shown with a number of brief examples.

  13. Fibrolase: Trials and Tribulations

    Science.gov (United States)

    Markland, Francis S.; Swenson, Steve

    2010-01-01

    Fibrolase is the fibrinolytic enzyme isolated from Agkistrodon contortrix contortrix (southern copperhead snake) venom. The enzyme was purified by a three-step HPLC procedure and was shown to be homogeneous by standard criteria including reverse phase HPLC, molecular sieve chromatography and SDS-PAGE. The purified enzyme is a zinc metalloproteinase containing one mole of zinc. It is composed of 203 amino acids with a blocked amino-terminus due to cyclization of the terminal Gln residue. Fibrolase shares a significant degree of homology with enzymes of the reprolysin sub-family of metalloproteinases including an active site homology of close to 100%; it is rapidly inhibited by chelating agents such as EDTA, and by alpha2-macroglobulin (α2Μ). The enzyme is a direct-acting thrombolytic agent and does not rely on plasminogen for clot dissolution. Fibrolase rapidly cleaves the A(α)-chain of fibrinogen and the B(β)-chain at a slower rate; it has no activity on the γ-chain. The enzyme exhibits the same specificity with fibrin, cleaving the α-chain more rapidly than the β-chain. Fibrolase was shown to have very effective thrombolytic activity in a reoccluding carotid arterial thrombosis model in the canine. A recombinant version of the enzyme was made in yeast by Amgen, Inc. (Thousand Oaks, CA, USA) and called alfimeprase. Alfimeprase is identical to fibrolase except for a two amino acid truncation at the amino-terminus and the insertion of a new amino-terminal amino acid in the truncated protein; these changes lead to a more stable enzyme for prolonged storage. Alfimeprase was taken into clinical trials by Nuvelo, Inc. (San Carlos, CA), which licensed the enzyme from Amgen. Alfimeprase was successful in Phase I and II clinical trials for peripheral arterial occlusion (PAO) and central venous access device (CVAD) occlusion. However, in Phase III trials alfimeprase did not meet the expected end points in either PAO or CVAD occlusion and in a Phaase II stroke trial

  14. The CHANGE trial

    DEFF Research Database (Denmark)

    Speyer, Helene; Norgaard, Hans Christian Brix; Birk, Merete

    2016-01-01

    Life expectancy in patients with schizophrenia is reduced by 20 years for men and 15 years for women compared to the general population. About 60% of the excess mortality is due to physical illnesses, with cardiovascular disease being dominant. CHANGE was a randomized, parallel-group, superiority...... cardiorespiratory fitness, physical activity, weight, diet and smoking. In conclusion, the CHANGE trial did not support superiority of individual lifestyle coaching or care coordination compared to treatment as usual in reducing cardiovascular risk in patients with schizophrenia spectrum disorders and abdominal...

  15. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.

    2015-01-01

    the members voted we calculated the median score among the nine members of the working group who completed the score. The document includes 25 recommendations regarding randomization, blocking and stratification, blinding, enhancing accuracy of patient-reported outcomes (PRO), selecting a study population......The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct...

  16. 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

  17. 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

  18. Ongoing therapeutic trials and outcome measures for Duchenne muscular dystrophy.

    Science.gov (United States)

    Govoni, Alessandra; Magri, Francesca; Brajkovic, Simona; Zanetta, Chiara; Faravelli, Irene; Corti, Stefania; Bresolin, Nereo; Comi, Giacomo P

    2013-12-01

    Muscular dystrophy is a heterogeneous group of genetic disorders characterised by progressive muscle tissue degeneration. No effective treatment has been discovered for these diseases. Preclinical and clinical studies aimed at the development of new therapeutic approaches have been carried out, primarily in subjects affected with dystrophinopathies (Duchenne and Becker muscular dystrophy). In this review, we outline the current therapeutic approaches and past and ongoing clinical trials, highlighting both the advantages and limits of each one. The experimental designs of these trials were based on different rationales, including immunomodulation, readthrough strategies, exon skipping, gene therapy, and cell therapy. We also provide an overview of available outcome measures, focusing on their reliability in estimating meaningful clinical improvement in order to aid in the design of future trials. This perspective is extremely relevant to the field considering the recent development of novel therapeutic approaches that will result in an increasing number of clinical studies over the next few years.

  19. Practical trials in medical education

    DEFF Research Database (Denmark)

    Tolsgaard, Martin G; Kulasegaram, Kulamakan M; Ringsted, Charlotte

    2017-01-01

    administration, quality of care, patient outcomes and cost. CONCLUSIONS: Practical trials in medical education may contribute to bridge the gap between education theory and practice and aid decision makers in making evidence-based choices and priorities. Conducting practical trials is not without challenges...... controlled settings generalise to the real-life education context. One way of bridging this gap is applying the concept of practical trials in medical education. In this paper we elaborate on characteristics of practical trials and based on examples from medical education we discuss the challenges...

  20. Experimental Object-Oriented Modelling

    DEFF Research Database (Denmark)

    Hansen, Klaus Marius

    and discuss techniques for handling and representing uncertainty when modelling in experimental system development. These techniques are centred on patterns and styles for handling uncertainty in object-oriented software architectures. Tools We present the Knight tool designed for collaborative modelling......This thesis examines object-oriented modelling in experimental system development. Object-oriented modelling aims at representing concepts and phenomena of a problem domain in terms of classes and objects. Experimental system development seeks active experimentation in a system development project...... through, e.g., technical prototyping and active user involvement. We introduce and examine “experimental object-oriented modelling” as the intersection of these practices. The contributions of this thesis are expected to be within three perspectives on models and modelling in experimental system...

  1. The possibility of critical realist randomised controlled trials.

    Science.gov (United States)

    Porter, Sam; McConnell, Tracey; Reid, Joanne

    2017-03-21

    Some realists have criticised randomised controlled trials for their inability to explain the causal relations that they identify; to take into account the influence of the social context of the interventions they evaluate; and to account for individual difference. However, among realists, there is controversy over whether it is possible to improve trials by making them realist, or whether realism and the philosophical assumptions underlying trials are incompatible. This paper contributes to the debate in Trials on this issue. The debate thus far has concentrated on the possibility of combining trial methodology with that of realist evaluation. We concur with the contention that it is not feasible to combine randomised controlled trial design with the realist evaluation approach. However, we argue that a different variant of realism, critical realism, provides a more appropriate theoretical grounding for realist trials. In contrast to realist evaluation, which regards social mechanisms as an amalgam of social resources and people's reasoning, critical realism insists on their distinction. It does so on the basis of its assertion of the need to distinguish between social structures (in which resources lie) and human agency (which is at least partly guided by reasoning). From this perspective, conceiving of social mechanisms as external to participants can be seen as a valid methodological strategy for supplementing the exclusive concentration of trials on outcomes. While accepting realist evaluation's insistence that causality in open systems involves a configuration of multiple generative mechanisms, we adopt the critical realist interpretation of the experimental method, which sees it as creating artificial closure in order to identify the effects of specific causal mechanisms. If randomised controlled trials can be regarded as epidemiological proxies that substitute probabilistic controls over extraneous factors for closed experiments, their examination of the

  2. Experimental evidence for action imitation in killer whales (Orcinus orca).

    Science.gov (United States)

    Abramson, José Z; Hernández-Lloreda, Victoria; Call, Josep; Colmenares, Fernando

    2013-01-01

    Comparative experimental studies of imitative learning have focused mainly on primates and birds. However, cetaceans are promising candidates to display imitative learning as they have evolved in socioecological settings that have selected for large brains, complex sociality, and coordinated predatory tactics. Here we tested imitative learning in killer whales, Orcinus orca. We used a 'do-as-other-does' paradigm in which 3 subjects witnessed a conspecific demonstrator's performance that included 15 familiar and 4 novel behaviours. The three subjects (1) learned the copy command signal 'Do that' very quickly, that is, 20 trials on average; (2) copied 100 % of the demonstrator's familiar and novel actions; (3) achieved full matches in the first attempt for 8-13 familiar behaviours (out of 15) and for the 2 novel behaviours (out of 2) in one subject; and (4) took no longer than 8 trials to accurately copy any familiar behaviour, and no longer than 16 trials to copy any novel behaviour. This study provides experimental evidence for body imitation, including production imitation, in killer whales that is comparable to that observed in dolphins tested under similar conditions. These findings suggest that imitative learning may underpin some of the group-specific traditions reported in killer whales in the field.

  3. Experimental Design and Some Threats to Experimental Validity: A Primer

    Science.gov (United States)

    Skidmore, Susan

    2008-01-01

    Experimental designs are distinguished as the best method to respond to questions involving causality. The purpose of the present paper is to explicate the logic of experimental design and why it is so vital to questions that demand causal conclusions. In addition, types of internal and external validity threats are discussed. To emphasize the…

  4. Observer bias in randomized clinical trials with time-to-event outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2014-01-01

    intravenous administration of the same drug, resulting in bias favouring the control intervention, RHR 1.33 (0.98 to 1.82). Seven trials of cytomegalovirus retinitis, tibial fracture and multiple sclerosis compared experimental interventions with standard control interventions, e.g. placebo, no-treatment......BACKGROUND: We wanted to evaluate the impact of nonblinded outcome assessors on estimated treatment effects in time-to-event trials. METHODS: Systematic review of randomized clinical trials with both blinded and nonblinded assessors of the same time-to-event outcome. Two authors agreed on inclusion...... or active control, resulting in bias favouring the experimental intervention, RHR 0.73 (0.57 to 0.93), indicating an average exaggeration of nonblinded hazard ratios by 27% (7% to 43%). CONCLUSIONS: Lack of blinded outcome assessors in randomized trials with subjective time-to-event outcomes causes high...

  5. Built-in hyperspectral camera for smartphone in visible, near-infrared and middle-infrared lights region (first report): trial products of beans-size Fourier-spectroscopic line-imager and feasibility experimental results of middle-infrared spectroscopic imaging

    Science.gov (United States)

    Ishimaru, Ichiro; Kawashima, Natsumi; Hosono, Satsuki

    2016-05-01

    We had already proposed and reported the little-finger size hyperspectral-camera that was able to be applied to visible and infrared lights. The proposed method has been expected to be mounted on smartphones for healthcare sensors, and unmanned air vehicles such as drones for antiterrorism measures or environmental measurements. In this report, we will mention the trial product of the thumb size apparatus whose lens diameter was 5[mm]. The proposed Fourier spectroscopic imager is a kind of wavefront-division and common-path phase-shift interferometers. We installed the relative inclined phase-shifter onto optical Fourier transform plane of infinity corrected optical systems. The infinity corrected optical systems was configured with an objective lens and a cylindrical imaging lens. The relative inclined phase-shifter, what was made from a thin glass less than 0.3[mm] thick, had the wedge-prism and cuboid-glass region, because half surface of a thin glass was polished at an oblique angle of around 1[deg.]. The collimated half flux of objective beams derived from single-bright points on objective surface penetrate through the wedge prism and the cuboid glass respectively. These two beams are interfered each other and form the infererogram as spatial fringe patterns. In this case, the horizontal axis on 2-dimensional light receiving device is assigned to the amount of phase-shift. And also the vertical axis is assigned to the imaging coordinates on a line view field. Thus, by installing thin phase-shifter onto optical Fourier transform plane, the line spectroscopic imager, what obtains 1 dimensional spectral character distributions, were able to be realized.

  6. An Experimental Test of a Biodynamic Method of Weed Suppression: The Biodynamic Seed Peppers

    OpenAIRE

    Bruce Kenneth Kirchoff

    2016-01-01

    An experimental test of a biodynamic agriculture method of weed suppression was carried out in growth chambers to establish the feasibility of the method as a preliminary to field trials. Four generations of Brassica rapa plants were used in a randomized block design. Treated flats received ashed seeds prepared according to biodynamic indications. Seed weight and counts were measured at the end of each generation, and germination of the control and experimental seed was investigated at the en...

  7. Topics in clinical trial management

    NARCIS (Netherlands)

    B.A. Kirwan (Bridget Anne)

    2004-01-01

    textabstractThe aim of this thesis is to show how clinical trial conduct can be managed while respecting the underlying scientific principles. Chapter 2 describes the main results of PICO (PImobendan in COngestive heart failure), a trial which investigated a positive inotropic agent in patients

  8. Defendants' Rights in Criminal Trials.

    Science.gov (United States)

    Martin, Ralph C., II; Keeley, Elizabeth

    1997-01-01

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

  9. Erythropoietin in patients with aneurysmal subarachnoid haemorrhage: a double blind randomised clinical trial

    DEFF Research Database (Denmark)

    Springborg, J B; Møller, C; Gideon, P

    2007-01-01

    BACKGROUND: Erythropoietin (EPO) is neuroprotective in experimental models of stroke and subarachnoid haemorrhage (SAH) and possibly in patients with thromboembolic stroke. We studied the efficacy and safety of EPO in patients with SAH. METHODS: A larger scale clinical trial was planned...... no statistically significant group differences in the primary or secondary outcome measures. EPO was well tolerated. CONCLUSIONS: Beneficial effects of EPO in patients with SAH cannot be excluded or concluded on the basis of this study and larger scale trials are warranted....

  10. Open source in Experimental Psychology

    OpenAIRE

    Dalmaijer, Edwin

    2015-01-01

    Talk on using open-source software in experimental psychology. Presented on 3 March 2015, at the Attention, Brain and Cognitive Development group (http://www.psy.ox.ac.uk/research/attention-brain-and-cognitive-development-group) at the University of Oxford's Department of Experimental Psychology.

  11. Experimental Mathematics and Computational Statistics

    Energy Technology Data Exchange (ETDEWEB)

    Bailey, David H.; Borwein, Jonathan M.

    2009-04-30

    The field of statistics has long been noted for techniques to detect patterns and regularities in numerical data. In this article we explore connections between statistics and the emerging field of 'experimental mathematics'. These includes both applications of experimental mathematics in statistics, as well as statistical methods applied to computational mathematics.

  12. Cameroon Journal of Experimental Biology

    African Journals Online (AJOL)

    The Cameroon Journal of Experimental Biology is the official journal of the Cameroon Forum for Biological Sciences (CAFOBIOS). It is an interdisciplinary journal for the publication of original research papers, short communications and review articles in all fields of experimental biology including biochemistry, physiology, ...

  13. A standard experimental 'chemical burn'.

    Science.gov (United States)

    Kim, J; Weibel, T J; Carter, E J; Calobrace, M B; Foldi, J F; Zawacki, B E

    1994-06-01

    To establish a standard method for producing experimental cutaneous injuries caused by contact with corrosive liquids, we modified an apparatus and method recommended by Walker and Mason in 1967 to produce experimental thermal burns. The resulting procedure proved to be safe, reproducible, humane and efficient and can be used with a wide variety of corrosive liquids.

  14. LTDNA Evidence on Trial.

    Science.gov (United States)

    Roberts, Paul

    2016-01-01

    Adopting the interpretative/hermeneutical method typical of much legal scholarship, this article considers two sets of issues pertaining to LTDNA profiles as evidence in criminal proceedings. The section titled Expert Evidence as Forensic Epistemic Warrant addresses some rather large questions about the epistemic status and probative value of expert testimony in general. It sketches a theoretical model of expert evidence, highlighting five essential criteria: (1) expert competence; (2) disciplinary domain; (3) methodological validity; (4) materiality; and (5) legal admissibility. This generic model of expert authority, highlighting law's fundamentally normative character, applies to all modern forms of criminal adjudication, across Europe and farther afield. The section titled LTDNA Evidence in UK Criminal Trials then examines English and Northern Irish courts' attempts to get to grips with LTDNA evidence in recent cases. Better appreciating the ways in which UK courts have addressed the challenges of LTDNA evidence may offer some insights into parallel developments in other legal systems. Appellate court rulings follow a predictable judicial logic, which might usefully be studied and reflected upon by any forensic scientist or statistician seeking to operate effectively in criminal proceedings. Whilst each legal jurisdiction has its own unique blend of jurisprudence, institutions, cultures and historical traditions, there is considerable scope for comparative analysis and cross-jurisdictional borrowing and instruction. In the spirit of promoting more nuanced and sophisticated international interdisciplinary dialogue, this article examines UK judicial approaches to LTDNA evidence and begins to elucidate their underlying institutional logic. Legal argument and broader policy debates are not confined to considerations of scientific validity, contamination risks and evidential integrity, or associated judgments of legal admissibility or exclusion. They also crucially

  15. Do Current Clinical Trials Meet Society's Needs?

    National Research Council Canada - National Science Library

    Stuart J Pocock; Bernard J Gersh

    2014-01-01

    .... Topics covered include the inadequacy of trial research on medical devices, problems with industry-sponsored trials, the lack of head-to-head trials of new effective treatments, the need for wiser...

  16. Aterosclerose experimental em coelhos Experimental atherosclerosis in rabbits

    Directory of Open Access Journals (Sweden)

    Waleska C. Dornas

    2010-08-01

    Full Text Available Numerosas pesquisas têm sido realizadas utilizando modelos experimentais para estudar o desenvolvimento da aterosclerose com dieta induzindo hiperlipidemia. Devido ao fato de que coelhos são muito sensíveis a dietas ricas em colesterol e acumulam grandes quantidades no plasma, a utilização destes animais como modelo experimental para avaliar o desenvolvimento de aterosclerose é de grande relevância, trazendo informação sobre fatores que contribuem para progressão e regressão aplicadas a situações humanas. Sendo assim, nessa revisão a função aterogênica do colesterol é mostrada em trabalhos que incluem o coelho como modelo experimental, uma vez que este animal tornou-se o mais popular modelo experimental de aterosclerose.Many researches have been conducted in experimental models in order to study the development of atherosclerosis from hyperlipidemia-inducing diets. Since rabbits are very sensitive to cholesterol-rich diets and accumulate large amounts of cholesterol in their plasma, their use as experimental models to evaluate the development of atherosclerosis is highly relevant and brings information on factors that contribute to the progression and regression of this condition that can be applied to humans. As such, this review includes studies on the atherogenic function of cholesterol based on rabbits as the experimental model, since they have become the most largely used experimental model of atherosclerosis.

  17. Experimental human pneumococcal carriage models for vaccine research.

    Science.gov (United States)

    Ferreira, Daniela M; Jambo, Kondwani C; Gordon, Stephen B

    2011-09-01

    Pneumococcal conjugate vaccines have had unprecedented success in controlling vaccine-type invasive pneumococcal disease. As serotype replacement and the complexity of designing vaccines to multiple capsular polysaccharides ultimately pose a threat to these vaccines, the development of alternative protein vaccines is important. Protein vaccines offer the promise of extended serotype coverage, reduced cost, and improved protection against otitis media and pneumococcal pneumonia. As placebo-controlled trials are not currently ethically justifiable, human pneumococcal challenge models using prevention of carriage as a test endpoint offer an attractive link between preclinical studies and clinical efficacy trials. Experimental human pneumococcal carriage studies offer a means of describing mechanisms of protection against carriage and a clinical tool to choose between vaccine candidates. Copyright © 2011 Elsevier Ltd. All rights reserved.

  18. Experimental Evolution with Caenorhabditis Nematodes

    Science.gov (United States)

    Teotónio, Henrique; Estes, Suzanne; Phillips, Patrick C.; Baer, Charles F.

    2017-01-01

    The hermaphroditic nematode Caenorhabditis elegans has been one of the primary model systems in biology since the 1970s, but only within the last two decades has this nematode also become a useful model for experimental evolution. Here, we outline the goals and major foci of experimental evolution with C. elegans and related species, such as C. briggsae and C. remanei, by discussing the principles of experimental design, and highlighting the strengths and limitations of Caenorhabditis as model systems. We then review three exemplars of Caenorhabditis experimental evolution studies, underlining representative evolution experiments that have addressed the: (1) maintenance of genetic variation; (2) role of natural selection during transitions from outcrossing to selfing, as well as the maintenance of mixed breeding modes during evolution; and (3) evolution of phenotypic plasticity and its role in adaptation to variable environments, including host–pathogen coevolution. We conclude by suggesting some future directions for which experimental evolution with Caenorhabditis would be particularly informative. PMID:28592504

  19. Experimental Entanglement of Four Particles

    Science.gov (United States)

    2016-09-22

    electrons and protons with quantum Monte Carlo methods; their simulations were, however, performed with trial wavefunctions based on the fixed static...type first- principles simulations. The basic formalism was first presented by Marx and Parrinello12. Recently this scheme was further developed by the

  20. Informed consent in human experimentation before the Nuremberg code.

    Science.gov (United States)

    Vollmann, J; Winau, R

    1996-12-07

    The issue of ethics with respect to medical experimentation in Germany during the 1930s and 1940s was crucial at the Nuremberg trials and related trials of doctors and public health officials. Those involved in horrible crimes attempted to excuse themselves by arguing that there were no explicit rules governing medical research on human beings in Germany during the period and that research practices in Germany were not different from those in allied countries. In this context the Nuremberg code of 1947 is generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent. New research, however, indicates that ethical issues of informed consent in guidelines for human experimentation were recognised as early as the nineteenth century. These guidelines shed light on the still contentious issue of when the concepts of autonomy, informed consent, and therapeutic and non-therapeutic research first emerged. This issue assumes renewed importance in the context of current attempts to assess liability and responsibility for the abuse of people in various experiments conducted since the second world war in the United States, Canada, Russia, and other nations.

  1. Methods of analysis and number of replicates for trials with large numbers of soybean genotypes

    Directory of Open Access Journals (Sweden)

    Gilvani Matei

    Full Text Available ABSTRACT: The aim of this study was to evaluate the experimental precision of different methods of statistical analysis for trials with large numbers of soybean genotypes, and their relationship with the number of replicates. Soybean yield data (nine trials; 324 genotypes; 46 cultivars; 278 lines; agricultural harvest of 2014/15 were used. Two of these trials were performed at the same location, side by side, forming a trial with six replicates. Each trial was analyzed by the randomized complete block, triple lattice design, and use of the Papadakis method. The selective accuracy, least significant difference, and Fasoulas differentiation index were estimated, and model assumptions were tested. The resampling method was used to study the influence of the number of replicates, by varying the number of blocks and estimating the precision measurements. The experimental precision indicators of the Papadakis method are more favorable as compared to the randomized complete block design and triple lattice. To obtain selective accuracy above the high experimental precision range in trials with 324 soybean genotypes, two repetitions can be used, and data can be analyzed using the randomized complete block design or Papadakis method.

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

    Directory of Open Access Journals (Sweden)

    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

  3. Statistical frequency-dependent analysis of trial-to-trial variability in single time series by recurrence plots

    Directory of Open Access Journals (Sweden)

    Tamara eTosic

    2016-01-01

    Full Text Available For decades, research in neuroscience has supported the hypothesis that brain dynamics exhibits recurrent metastable states connected by transients, which together encode fundamental neural information processing. To understand the system’s dynamics it is important to detect such recurrence domains, but it is challenging to extract them from experimental neuroscience datasets due to the large trial-to-trial variability. The proposed methodology extracts recurrent metastable states in univariate time series by transforming datasets into their time-frequency representations and computing recurrence plots based on instantaneous spectral power values in various frequency bands. Additionally, a new statistical inference analysis compares different trial recurrence plots with corresponding surrogates to obtain statistically significant recurrent structures. This combination of methods is validated by applying it to two artificial datasets. In a final study of visually-evoked Local Field Potentials in partially anesthetized ferrets, the methodology is able to reveal recurrence structures of neural responses with trial-to-trial variability. Focusing on different frequency bands, the delta-band activity is much less recurrent than alpha-band activity. Moreover, alpha-activity is susceptible to pre-stimuli, while delta-activity is much less sensitive to pre-stimuli. This difference in recurrence structures in different frequency bands indicates diverse underlying information processing steps in the brain.

  4. 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.

  5. 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.

  6. Uniformity trial size in estimates of plot size in restrict areas

    Directory of Open Access Journals (Sweden)

    Diogo Vanderlei Schwertner

    Full Text Available ABSTRACTThe aim of this study was to determine the uniformity trial size when estimating optimum plot size in order to evaluate fresh phytomass in lettuce plants and fruit weight in sweet peppers. Production data, collected in uniformity trial on lettuce in a plastic greenhouse in both summer and winter, lettuce in plastic tunnels in autumn and winter, and sweet pepper in a plastic greenhouse in the summer-autumn and spring-summer seasons, were used to plan different uniformity trial sizes in crop rows. In all the experiments, each plant was evaluated individually and considered as a basic experimental unit. For each size in a uniformity trial, 3,000 resamples, randomly taken with replacement, were used to estimate optimum plot size. Uniformity trial using 27 basic experimental units to evaluate the fresh phytomass of lettuce plants, and with 29 basic experimental units to assess fruit weight in sweet pepper, are sufficient to estimate optimum plot size, with an amplitude of the 95% confidence interval of less than or equal to two basic experimental units.

  7. Mouth rinsing with a carbohydrate solution does not influence cycle time trial performance in the heat.

    Science.gov (United States)

    Watson, Phillip; Nichols, David; Cordery, Philip

    2014-09-01

    Ten endurance-trained males were recruited to examine the possible role of carbohydrate (CHO) receptors in the mouth influencing exercise performance in the heat. Volunteers completed an incremental test to exhaustion to determine peak oxygen uptake, a familiarisation trial, followed by 2 experimental trials. Trials consisted of a 1-h time trial undertaken in a climatic chamber maintained at 30 °C, 60% relative humidity. Immediately before, and at regular intervals throughout exercise, subjects ingested a bolus of water and then were provided with either a placebo (PLA) or a 6.4% glucose (CHO) solution to rinse in the mouth for 10 s before being expectorated. There was no difference in total work done between the PLA and CHO trials (758.8 ± 149.0 kJ; 762.6 ± 141.1 kJ; P = 0.951). Pacing was also similar, with no differences in power output apparent during the experimental trials (P = 0.546). Core temperature (P = 0.615), heart rate (P = 0.505), ratings of perceived exertion (P = 0.181), and perceived thermal stress (P = 0.416) were not influenced by the nature of the intervention. Blood glucose concentrations were similar during the CHO and PLA trials (P = 0.117). In contrast to the findings of several studies undertaken in temperate conditions, the present investigation failed to support role of oral sensing of CHO in influencing performance during prolonged exercise in warm conditions.

  8. 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

  9. P. falciparum Enhances HIV Replication in an Experimental Malaria Challenge System: e39000

    National Research Council Canada - National Science Library

    Marika Orlov; Florin Vaida; Olivia C Finney; David M Smith; Angela K Talley; Ruobing Wang; Stefan H Kappe; Qianqian Deng; Robert T Schooley; Patrick E Duffy

    2012-01-01

    ... naïve volunteers experimentally infected with P. falciparum in a malaria challenge trial.PBMCs collected before the malaria challenge and at several time points post-infection were infected with HIV-1 and co-cultured with either P...

  10. The influence of diet on Lawsonia intracellularis colonization in pigs upon experimental challenge

    DEFF Research Database (Denmark)

    Boesen, Henriette T.; Jensen, Tim Kåre; Schmidt, Anja S.

    2004-01-01

    The objective of this investigation was to study if different feeding strategies influence experimental infections of pigs with Lawsonia intracellularis, the causative agent of proliferative enteropathy. In three sequential trials, a total of 144 weaned pigs were fed five different diets all made...

  11. Experimental Vaccine for Mosquito-Borne Chikungunya Virus Rates Well in Clinical Study | FNLCR

    Science.gov (United States)

    An experimental vaccine for mosquito-borne chikungunya virus, which spread to the U.S. this year, appears to be safe and well-tolerated while offering protection against the virus, according to the results of a first-in-human clinical trial. The vacc

  12. Computer Assisted English Language Learning in Costa Rican Elementary Schools: An Experimental Study

    Science.gov (United States)

    Alvarez-Marinelli, Horacio; Blanco, Marta; Lara-Alecio, Rafael; Irby, Beverly J.; Tong, Fuhui; Stanley, Katherine; Fan, Yinan

    2016-01-01

    This study presents first-year findings of a 25-week longitudinal project derived from a two-year longitudinal randomized trial study at the elementary school level in Costa Rica on effective computer-assisted language learning (CALL) approaches in an English as a foreign language (EFL) setting. A pre-test-post-test experimental group design was…

  13. Planning an Academic Clinical Trial.

    Science.gov (United States)

    Champion, Kim M; Jones, Gemma R

    2015-01-01

    Clinical trials are performed to discover or verify the efficacy and safety of one or more investigational medicinal product (IMP). Biological medicinal products, including gene therapies, offer groundbreaking new opportunities for the treatment of disease and injury, but they are also highly regulated and trials with these products can be logistically challenging to set up and execute. To ensure a compliant and successful trial, it is important to know and understand the regulatory framework, and to be aware of available guidance documents published to advise the different stakeholders on how to develop, manufacture, handle, administer, or destroy these products safely and legally. This chapter summarizes the standard requirements and considerations applicable for clinical trials with IMPs and also describes additional requirements for trials with gene therapies or genetically modified microorganisms (GMM).This chapter has been written from the perspective of a UK noncommercial (academic) sponsor. As such, the discussion and guidance has its basis in gene therapy research as governed by UK law. Nevertheless, European legislation and guidance documents are also referenced; most of the following recommendations will be applicable to clinical trials with a gene therapy medicinal product in any European Member State, and the overriding principles would be applicable to any trial.

  14. Experimental context modulates warning signal effects

    Directory of Open Access Journals (Sweden)

    W. Machado-Pinheiro

    2004-07-01

    Full Text Available Previous studies have shown that saccadic eye responses but not manual responses were sensitive to the kind of warning signal used, with visual onsets producing longer saccadic latencies compared to visual offsets. The aim of the present study was to determine the effects of distinct warning signals on manual latencies and to test the premise that the onset interference, in fact, does not occur for manual responses. A second objective was to determine if the magnitude of the warning effects could be modulated by contextual procedures. Three experimental conditions based on the kind of warning signal used (visual onset, visual offset and auditory warning were run in two different contexts (blocked and non-blocked. Eighteen participants were asked to respond to the imperative stimulus that would occur some milliseconds (0, 250, 500 or 750 ms after the warning signal. The experiment consisted in three experimental sessions of 240 trials, where all the variables were counterbalanced. The data showed that visual onsets produced longer manual latencies than visual offsets in the non-blocked context (275 vs 261 ms; P < 0.001. This interference was obtained, however, only for short intervals between the warning and the stimulus, and was abolished when the blocked context was used (256 vs 255 ms; P = 0.789. These results are discussed in terms of bottom-up and top-down interactions, mainly those related to the role of attentional processing in canceling out competitive interactions and suppressive influences of a distractor on the relevant stimulus.

  15. Preclinical electrogastrography in experimental pigs

    Science.gov (United States)

    Květina, Jaroslav; Varayil, Jithinraj Edakkanambeth; Ali, Shahzad Marghoob; Kuneš, Martin; Bureš, Jan; Tachecí, Ilja; Rejchrt, Stanislav; Kopáčová, Marcela

    2010-01-01

    Surface electrogastrography (EGG) is a non-invasive means of recording gastric myoelectric activity or slow waves from cutaneous leads placed over the stomach. This paper provides a comprehensive review of preclinical EGG. Our group recently set up and worked out the methods for EGG in experimental pigs. We gained our initial experience in the use of EGG in assessment of porcine gastric myoelectric activity after volume challenge and after intragastric administration of itopride and erythromycin. The mean dominant frequency in pigs is comparable with that found in humans. EGG in experimental pigs is feasible. Experimental EGG is an important basis for further preclinical projects in pharmacology and toxicology. PMID:21217873

  16. Experimentation on humans and nonhumans.

    Science.gov (United States)

    Pluhar, Evelyn B

    2006-01-01

    In this article, I argue that it is wrong to conduct any experiment on a nonhuman which we would regard as immoral were it to be conducted on a human, because such experimentation violates the basic moral rights of sentient beings. After distinguishing the rights approach from the utilitarian approach, I delineate basic concepts. I then raise the classic "argument from marginal cases" against those who support experimentation on nonhumans but not on humans. After next replying to six important objections against that argument, I contend that moral agents are logically required to accord basic moral rights to every sentient being. I conclude by providing criteria for distinguishing ethical from unethical experimentation.

  17. Experimental design a chemometric approach

    CERN Document Server

    Deming, SN

    1987-01-01

    Now available in a paperback edition is a book which has been described as ``...an exceptionally lucid, easy-to-read presentation... would be an excellent addition to the collection of every analytical chemist. I recommend it with great enthusiasm.'' (Analytical Chemistry). Unlike most current textbooks, it approaches experimental design from the point of view of the experimenter, rather than that of the statistician. As the reviewer in `Analytical Chemistry' went on to say: ``Deming and Morgan should be given high praise for bringing the principles of experimental design to the level of the p

  18. Huts and Nuts’ or ’Hearts and Minds?’ -- Anthropologists and Operational Art

    Science.gov (United States)

    2008-12-06

    effort to understand Japan and the Japanese that became most visible—after the war. One reason was the publication of The Chrysanthemum and the Sword...the Japanese for the U.S. government. When The Chrysanthemum and the Sword was published in 1946 more than 500,000 Americans still remained in Japan...Released 6 November 2007. http://www.aaanet.org/pdf/EB_Resolution_110807.pdf. Benedict, Ruth. The Chrysanthemum and the Sword: Patterns of Japanese

  19. The image of the black soul: From the hut near the Congo to the ...

    African Journals Online (AJOL)

    The black man, argues the paper, has drunk from life-giving essences, and thereby borrowed from immortality. The black soul is capable of moving up and down the hierarchy of life or being. It is therefore part of the essence of the black soul to move from slaves to freemen. The paper concludes that as the rivers deepen with ...

  20. Source passing test in Vesivehmaa air field - 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

    Carborne radiation monitors were tested for point source responses at distances 10 m, 20 m, 50 m, 100 m, 150 m, and 200 m using speed of 20 km h{sup -1} and 50 km h{sup -1}. A large pressurised ionisation chamber (PIC), and HPGe detector (relative efficiency 36.9%) and a NaI(Tl) scintillator detector (size 5`x5`) were used. The sources had a nominal activity of 22 MBq ({sup 60}Co) and 1.85 GBq ({sup 137}Cs). The {sup 60}Co source strength was under the detection limit in all measurements. The detection of the {sup 137}Cs source is visually clear up to 50 m for the spectrometers and up to 20 m for PIC. Statistical analysis shows that {sup 137}Cs source could be detected up to 100 m with the spectrometers and up to 50 m with PIC if the background is well known. (au).

  1. Airborne fallout mapping of {sup 137}Cs - 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 create a fallout map of {sup 137}Cs on 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 NaI system (5`x5`). Both systems produced similar maps. The average {sup 137}Cs fallout within the area (lakes and ponds included) was 88 kBq m{sup -2,} the maximum value being 161 kBq m{sup -2}. In an emergency the HPGe is superior to NaI because of its better energy resolution, giving possibility to obtain nuclide-specific results. (au).

  2. From holes to huts: reconstructing an extinct type of architecture at the Sixth Nile Cataract

    Czech Academy of Sciences Publication Activity Database

    Varadzin, Ladislav; Varadzinová, L.; Pacina, J.

    2017-01-01

    Roč. 91, č. 357 (2017), s. 589-604 ISSN 0003-598X Institutional support: RVO:67985912 Keywords : North Africa * Sudan * Sixth Nile Cataract * Mesolithic * architecture * drilled holes Subject RIV: AC - Archeology, Anthropology, Ethnology Impact factor: 1.536, year: 2016

  3. “I Built My Hut near the Congo”: Langston Hughes's Aesthetic Debt ...

    African Journals Online (AJOL)

    Despite the immense contribution of George E. Kent, Richard K. Barksdale, Akiba Sullivan Harper, R. Baxter Miller and others to Hughes scholarship generally, a great deal still needs to be done, especially with respect to the poet's adaptation of aesthetic material from the African world view to illuminate his verse. True ...

  4. Making controlled experimentation more informative in inquiry investigations

    Science.gov (United States)

    McElhaney, Kevin Wei Hong

    This dissertation incorporates three studies that examine how the design of inquiry based science instruction, dynamic visualizations, and guidance for experimentation contribute to physics students' understanding of science. I designed a week-long, technology-enhanced inquiry module on car collisions that logs students' interactions with a visualization. Students studied the module and responded to pretests, posttests, and embedded prompts that assessed students' understanding of motion graphs and collisions. In Study 1, students (N=148) made large, significant overall pretest to posttest gains. Regression models showed that the propensity for students to conduct controlled trials was the strongest predictor of learning when controlling for prior knowledge and other experimentation measures. Successful learners employed a goal-directed experimentation approach that connected their experimentation strategy to content knowledge. Study 2 investigated the effect of limiting students' experimentation on their planning, strategies, and learning outcomes. Students (N=58) made large, significant overall pretest to posttest gains. Students constrained to twelve trials isolated variables in their experiments better than the unconstrained students. However, the constrained students significantly underperformed the unconstrained students on the module assessments, indicating that isolating variables during experimentation did not lead to improved learning outcomes. In Study 3, students (N=166) were assigned to conditions that prompted them either to isolate or compare variables. Both groups made moderate, significant pretest to posttest gains. Students in the compare treatment used more diverse experimentation strategies than students in the isolate treatment. Compare students made nuanced interpretations of collision events based on threshold values. Case studies illustrate how comparing rather than isolating variables helped students use wide-ranging strategies to reach

  5. Frailty Intervention Trial (FIT

    Directory of Open Access Journals (Sweden)

    Lockwood Keri

    2008-10-01

    Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a

  6. Injection Moulding Simulation and Experimental Validation of Hearing Aid Shells

    DEFF Research Database (Denmark)

    Islam, Aminul; Li, Xiaoliu

    ) mode was adopted in this work to simulate the injection molding process of a hearing aid shell made of Polybutylene Terephthalate (PBT) filled with 30% glass fiber. The typical hearing aid shells are complex thin-walled structures made by injection molding. Highly sophisticated molds and lots...... of process optimizations by trial and errors are needed to make successful shells for hearing aids. In this context, a dedicated simulation tool can be very useful to reduce the time and cost for developing the new hearing aids. In this work, the injection molding experimental validation of the Moldex3D...

  7. Designing clinical trials for amblyopia.

    Science.gov (United States)

    Holmes, Jonathan M

    2015-09-01

    Randomized clinical trial (RCT) study design leads to one of the highest levels of evidence, and is a preferred study design over cohort studies, because randomization reduces bias and maximizes the chance that even unknown confounding factors will be balanced between treatment groups. Recent randomized clinical trials and observational studies in amblyopia can be taken together to formulate an evidence-based approach to amblyopia treatment, which is presented in this review. When designing future clinical studies of amblyopia treatment, issues such as regression to the mean, sample size and trial duration must be considered, since each may impact study results and conclusions. Copyright © 2015 Elsevier Ltd. All rights reserved.

  8. Optimizing odor-baited trap methods for collecting mosquitoes during the malaria season in The Gambia.

    Directory of Open Access Journals (Sweden)

    Musa Jawara

    Full Text Available BACKGROUND: Baited traps are potential tools for removal or surveillance of disease vectors. To optimize the use of counter-flow traps baited with human odor (nylon socks that had been worn for a single day to capture wild mosquitoes in the Gambia, investigations were conducted at a field experimental site. METHODOLOGY/PRINCIPAL FINDINGS: Experiments employing Latin square design were conducted with a set of six huts to investigate the effects of the following on overnight mosquito trap catches: (1 placement of traps indoors or immediately outdoors, CO(2 supply, and presence of a human subject in the hut; (2 trap height for collecting mosquitoes immediately outdoors; (3 height and distance from hut; (4 interaction between multiple traps around a single hut and entry of mosquitoes into huts. A total of 106,600 adult mosquitoes (9.1% Anopheles gambiae s.l., 4.0% other Anopheles species were collected over 42 nights. The high numbers of An. gambiae s.l. and other mosquitoes collected by odor-baited traps required CO(2 but were largely independent of the presence of a person sleeping in the hut or of trap placement indoors or outdoors. For outdoor collection that is considered less intrusive, traps opening 15 cm above the floor of the hut veranda were more highly effective than traps at other heights or further from the hut. There was no significant evidence of saturation or competition by the traps, with multiple traps around a hut each collecting almost as many mosquitoes as single traps and no effect on the numbers of mosquitoes entering the huts. CONCLUSIONS/SIGNIFICANCE: The outdoor trapping protocol is convenient to compare attractiveness of different odors or synthetic chemicals to malaria vectors and other wild mosquitoes. The finding that such traps are reliably attractive in the presence or absence of a human volunteer encourages their potential development as standardised surveillance tools.

  9. Modelling Trial-by-Trial Changes in the Mismatch Negativity

    Science.gov (United States)

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

    2013-01-01

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

  10. Multi-Directional Experimental Facility

    Data.gov (United States)

    Federal Laboratory Consortium — The ATLSS Multi-directional Experimental Laboratory was constructed in 1987 under funding from the National Science Foundation to be a major facility for large-scale...

  11. HIRENASD Experimental Data - matlab format

    Data.gov (United States)

    National Aeronautics and Space Administration — This resource contains the experimental data that was included in tecplot input files but in matlab files. dba1_cp has all the results is dimensioned (7,2) first...

  12. Strongly correlated systems experimental techniques

    CERN Document Server

    Mancini, Ferdinando

    2015-01-01

    The continuous evolution and development of experimental techniques is at the basis of any fundamental achievement in modern physics. Strongly correlated systems (SCS), more than any other, need to be investigated through the greatest variety of experimental techniques in order to unveil and crosscheck the numerous and puzzling anomalous behaviors characterizing them. The study of SCS fostered the improvement of many old experimental techniques, but also the advent of many new ones just invented in order to analyze the complex behaviors of these systems. Many novel materials, with functional properties emerging from macroscopic quantum behaviors at the frontier of modern research in physics, chemistry and materials science, belong to this class of systems. The volume presents a representative collection of the modern experimental techniques specifically tailored for the analysis of strongly correlated systems. Any technique is presented in great detail by its own inventor or by one of the world-wide recognize...

  13. Animal Experimentation in High Schools

    Science.gov (United States)

    Ansevin, Kystyna D.

    1970-01-01

    Recommends that teacher and student be provided with the broadest possible spectrum of meaningful and feasible experiments in which the comfort of the experimental animal is protected by the design of the experiment. (BR)

  14. An Experimental Text-Commentary

    Science.gov (United States)

    O'Brien, Joan

    1976-01-01

    An experimental text-commentary of selected passages from Sophocles'"Antigone" is described. The commentary is intended for students seeking more than a conventional translation who do not know enough Greek to use a standard commentary. (RM)

  15. GAUSS Project Trials Results

    Science.gov (United States)

    Di Fazio, Antonella; Vernucci, Antonio; Rossini, Eugenio

    2003-07-01

    the Consortium Partners. The former ones constitute the ground and space segments, the latter ones include the advanced user terminal and the applications. The assembled system was used as test-bed during the trail campaign, to validate and prove the provided services and developed applications.The GAUSS Demonstrator includes the following components:ß The Mobile User Terminal installed on a car (van) or on a boat. An innovative multi-mode user equipment was developed, consisting of the following main components:- An integrated NAV / COM digital receive front-end (DFRE), able to de-multiplex the NAV signals (the current GNSS1 band and the simulated Galileo bands), and the COM signal in the S-UMTS band;- For COM: a transmit front-end, and a baseband & control section operating in CDMA and supporting the upper protocol layers (UMTS packet transmission standard based - for short packet); a RF subsystem, including the L→S bands conversion;- For NAV: a GNSS (GPS, EGNOS) navigation receiver, the GNSS1 System (MTB - Mediterranean Test bed, ESTB / EGNOS System Test Bed) for navigation;* The Communication capacity on the INMARSAT 3F5 Satellite* The Gateway, located in LARIO Telespazio premises* The Lario07 Station* The Service Centre* The Service Provider.The GAUSS Demonstrator reflects all the main elements of a complete user platform for service provisioning: mobility assistance, safety and transport efficient management are the core of the developed applications. Applications were developed, specifically to provide reliable and effective services to the citizens: road info-mobility and fleet management, inland waterways vessel traffic management and information, port/terminals appointment monitoring & control, dangerous goods transhipment supervision, emergency assistance.A trial campaign, run into real environments, was performed in Summer 2002. GAUSS Demonstrator performances and benefits were validated with the direct involvement of an inter-modal transport user

  16. How to write an experimental research paper.

    Science.gov (United States)

    Pamir, M N

    2002-01-01

    The art and practice of academic neurosurgery are mastered by defining and learning the pertinent basic principles and skills. This article aims to present general guidelines to one of the many roles of a neurosurgeon: Writing an experimental research paper. Every research report must use the "IMRAD formula: introduction, methods, results and discussion". After the IMRAD is finished, abstract should be written and the title should be "created". Your abstract should answer these questions: "Why did you start?, what did you do?, what answer did you get?, and what does it mean?". Title of the research paper should be short enough to catch glance and memory of the reader and be long enough to give the essential information of what the paper is about. Writing about the results of the experiment is no easier than the research itself. As surgery, writing a scientific paper is also an improvisation, but general principles should be learned and used in practice. The most effective style of learning basic skills to construct a research paper is the "trial and error" type.

  17. Persuasion in experimental ultimatum games

    DEFF Research Database (Denmark)

    Andersson, Ola; Galizzi, Matteo M.; Hoppe, Tim

    2010-01-01

    We study persuasion effects in experimental ultimatum games and find that Proposers' payoffs significantly increase if, along with offers, they can send messages which Responders read before deciding. Higher payoffs are driven by both lower offers and higher acceptance rates.......We study persuasion effects in experimental ultimatum games and find that Proposers' payoffs significantly increase if, along with offers, they can send messages which Responders read before deciding. Higher payoffs are driven by both lower offers and higher acceptance rates....

  18. General footage ISOLDE experimental hall

    CERN Multimedia

    2016-01-01

    Overview of the ISOLDE experimental hall. Equipment and experiments. Taken from the WITCH / EBIS platform: ISOLDE hall infrastructure, GHM line, LA1, LA2, LA0, central beamline, COLLAPS experiment, CRIS experiment, ISOLTRAP experiment, laser guidance from building 508 into the hall for laser spectroscopy COLLAPS and CRIS. Taken from the HIE ISOLDE shielding tunnel roof: ISOLDE hall infrastructure, WITCH experiment, VITO line, TAS experiment. General footage: High Tension room entrance and EBIS platform, staircases and passages in the experimental hall.

  19. [The ethics of animal experimentation].

    Science.gov (United States)

    Goffi, Jean-Yves

    2013-01-01

    The paper starts with a short definition of animal experimentation, then three main approaches to the practice are considered: unconditional approval (as advocated by Claude Bernard), conditional and restricted approval (as advocated by Peter Singer) and strict prohibition (as advocated by Tom Regan and Gary Francione). It is argued that what is actually approved or condemned in animal experimentation is the value of the scientific enterprise.

  20. Experimental aspects of colour reconnection

    CERN Document Server

    Watson, M F

    1997-01-01

    This report summarises experimental aspects of the phenomena of colour reconnection in W+W- production, concentrating on charged multiplicity and event shapes, which were carried out as part of the Phenomenology Workshop on LEP2 Physics, Oxford, Physics Department and Keble College, 14-18 April, 1997. The work includes new estimates of the systematic uncertainty which may be attributed to colour reconnection effects in experimental measurements of Mw.

  1. Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Emanuelsson, Frida; Skou Thomsen, Ann Sofia

    2014-01-01

    BACKGROUND: Blinding patients in clinical trials is a key methodological procedure, but the expected degree of bias due to nonblinded patients on estimated treatment effects is unknown. METHODS: Systematic review of randomized clinical trials with one sub-study (i.e. experimental vs control....... There was a larger effect size difference in 10 acupuncture trials [-0.63 (-0.77 to -0.49)], than in the two non-acupuncture trials [-0.17 (-0.41 to 0.07)]. Lack of patient blinding also increased attrition and use of co-interventions: ratio of control group attrition risk 1.79 (1.18 to 2.70), and ratio of control...

  2. The Trident Warrior experimentation process

    OpenAIRE

    Barrett, Kevin R.

    2005-01-01

    The Chief of Naval Operations defines FORCEnet as the "operational construction and architectural framework for Naval Warfare in the Information Age which integrates warriors, sensors, networks, command and control, platforms and weapons into a networked, distributed combat force, scalable across the spectrum of conflict from seabed to space and sea to land." The Trident Warrior experiments are the Navy's premier FORCEnet Sea Trial experiments. The purpose of the Trident Warrior experiments i...

  3. Experimental therapies for yellow fever

    OpenAIRE

    Julander, Justin G.

    2012-01-01

    A number of viruses in the family Flaviviridae are the focus of efforts to develop effective antiviral therapies. Success has been achieved with inhibitors for the treatment of hepatitis C, and there is interest in clinical trials of drugs against dengue fever. Antiviral therapies have also been evaluated in patients with Japanese encephalitis and West Nile encephalitis. However, no treatment has been developed against the prototype flavivirus, yellow fever virus (YFV). Despite the availabili...

  4. Clinical Trials in Vision Research

    Science.gov (United States)

    ... Clinical Trials in Vision Research Booklet for Nook, iPad and iPhone (EPUB - 1.6MB) Download the Clinical ... NEI Office of Science Communications, Public Liaison, and Education. Technical questions about this website can be addressed ...

  5. Clinical Trials: Information and Options for People with Mood Disorders

    Science.gov (United States)

    ... Clinical Trials: Information and Options for People with Mood Disorders What are clinical trials? Clinical trials are research ... during a clinical trial? Clinical trials that test mood disorder treatments are usually conducted on an outpatient basis, ...

  6. 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.

  7. Experimental investigation of transverse flow estimation using transverse oscillation

    DEFF Research Database (Denmark)

    Udesen, Jesper; Jensen, Jørgen Arendt

    2003-01-01

    Conventional ultrasound scanners can only display the blood velocity component parallel to the ultrasound beam. Introducing a laterally oscillating field gives signals from which the transverse velocity component can be estimated using 2:1 parallel receive beamformers. To yield the performance...... with a mean relative bias of 6.3% and a mean relative standard deviation of 5.4% over the entire vessel length. With the experimental ultrasound scanner RASMUS the simulations are reproduced in an experimental flow phantom using a linear array transducer and vessel characteristics as in the simulations....... The flow is generated with the Compuflow 1000 programmable flow pump giving a parabolic velocity profile of the blood mimicking fluid in the flow phantom. The profiles are estimated for 310 trials each containing of 32 data vectors. The relative mean bias over entire blood vessel is found to be 10...

  8. 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

  9. 5 CFR 316.304 - Trial period.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Trial period. 316.304 Section 316.304... Term Employment § 316.304 Trial period. (a) The first year of service of a term employee is a trial... completion of the required trial period in the same manner as prescribed by § 315.802 of this chapter. (b...

  10. 32 CFR 935.105 - Trial.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Trial. 935.105 Section 935.105 National Defense... CODE Criminal Actions § 935.105 Trial. (a) If the accused pleads not guilty, he is entitled to a trial... Court considers practicable and necessary to the ends of justice. There is no trial by jury. (b) All...

  11. 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.

  12. The classic caries clinical trial: constraints and opportunities.

    Science.gov (United States)

    Stamm, J W

    2004-01-01

    The history of clinical trials would include events in 1747 on board the Salisbury, a British Navy vessel at sea with 12 seamen critically ill with scurvy. Involving these 12 sailors in a study, an officer on board by the name of Lind evaluated six potential treatments for scurvy, and rapidly reached the conclusion that daily consumption of citrus fruits returned the men fit for duty in approximately six days (Bull, 1959). The concept of experimental randomization was first developed by Sir R.A. Fisher (1925, 1926), and the method was introduced to medical research via a study of tuberculosis treatment by Amberson and co-workers (1931), who randomized 24 TB patients into two groups, one to receive the experimental therapy, the other serving as the control. Amberson et al. also incorporated the concept of blinding into their study. Sir Austin Bradford Hill codified and built on the principles of scientific experimentation developed by Fisher, and introduced the use of random numbers in the allocation of patients in the British Medical Research Council (1948) study of the effect of streptomycin in the treatment of tuberculosis (Daniels and Hill, 1952; Hill, 1952). The first applications of clinical trial methodology for testing interventions on dental, oral, and maxillofacial diseases and conditions are more difficult to determine. For dental caries prevention, however, Chilton and Fertig (1958) and Slack and Martin (1964) were certainly among the early caries clinical trial pioneers. As clinical trials have come into the mainstream of clinical research in medicine and dentistry, a great deal of developmental work has focused on their methodological enhancement. The most successful of these efforts have come from fruitful, ongoing collaborations among clinician investigators, biostatisticians, data management specialists, biomedical ethicists, and others with an academic interest in clinical trial design and utilization. During the past 25 years, the emergence of

  13. 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.

  14. Frailty Intervention Trial (FIT).

    Science.gov (United States)

    Fairhall, Nicola; Aggar, Christina; Kurrle, Susan E; Sherrington, Catherine; Lord, Stephen; Lockwood, Keri; Monaghan, Noeline; Cameron, Ian D

    2008-10-13

    Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity). Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty.We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a new approach to the treatment of older people at risk of further

  15. a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MS Yıldırım

    2016-02-01

    Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.

  16. LTDNA Evidence on Trial

    Directory of Open Access Journals (Sweden)

    Paul Roberts

    2016-10-01

    factfinders in criminal trials.

  17. EXPERIMENTAL

    African Journals Online (AJOL)

    denise

    CHEMICAL AND ANTICONVULSANT SCREENING OF CRINUM JAGUS. M.O. Edema* and F.E. Okieimen. Chemistry Department, University of Benin, Benin City, Nigeria. E-mail: marydema@uniben.edu. ABSTRACT. INTRODUCTION ... pharmacological evaluation of some plant material that are frequently used locally as.

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

    Directory of Open Access Journals (Sweden)

    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.

  19. Trial history biases the spatial programming of antisaccades.

    Science.gov (United States)

    Rastgardani, Tara; Lau, Victor; Barton, Jason J S; Abegg, Mathias

    2012-10-01

    The historical context in which saccades are made influences their latency and error rates, but less is known about how context influences their spatial parameters. We recently described a novel spatial bias for antisaccades, in which the endpoints of these responses deviate towards alternative goal locations used in the same experimental block, and showed that expectancy (prior probability) is at least partly responsible for this 'alternate-goal bias'. In this report we asked whether trial history also plays a role. Subjects performed antisaccades to a stimulus randomly located on the horizontal meridian, on a 40° angle downwards from the horizontal meridian, or on a 40° upward angle, with all three locations equally probable on any given trial. We found that the endpoints of antisaccades were significantly displaced towards the goal location of not only the immediately preceding trial (n - 1) but also the penultimate (n - 2) trial. Furthermore, this bias was mainly present for antisaccades with a short latency of programming of upcoming antisaccades, that this historical effect persists over many seconds, and that it influences mainly rapidly generated eye movements. Because corrective saccades eliminate the historical bias, we suggest that the bias arises in processes generating the response vector, rather than processes generating the perceptual estimate of goal location.

  20. [Key aspects in interpreting clinical trials in radiology].

    Science.gov (United States)

    Díaz Gómez, L; García Villar, C; Seguro Fernández, Á

    2015-01-01

    A clinical trial is an experimental study to evaluate the efficacy and safety of a treatment or diagnostic technique in human beings. To ensure the methodological quality of a clinical trial and the validity of its results, various checklists have been elaborated to identify biases that could invalidate its conclusions. This article focuses on the points we need to consider in the critical evaluation of a clinical trial. We can usually find this information in the "materials and methods" and "results" sections of articles. Randomization, follow-up (or analysis of losses), blinding, and equivalence between groups (apart from the intervention itself) are some key aspects related to design. In the "results" section, we need to consider what measures of clinical efficacy were used (relative risk, odds ratio, or number needed to treat, among others) and the precision of the results (confidence intervals). Once we have confirmed that the clinical trial fulfills these criteria, we need to determine whether the results can be applied in our environment and whether the benefits obtained justify the risks and costs involved. Copyright © 2014 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

  1. Reperfusion injury in humans: a review of clinical trials on reperfusion injury inhibitory strategies.

    Science.gov (United States)

    Dirksen, Maurits T; Laarman, Gerrit J; Simoons, Maarten L; Duncker, Dirk J G M

    2007-06-01

    The principal therapy in patients with myocardial infarction to limit infarct size is myocardial reperfusion by mechanical or pharmacological intervention. Reperfusion has been proposed to cause myocardial injury beyond that caused by the preceding ischaemia, termed "reperfusion injury" (RI). While the precise mechanism of RI is still incompletely understood, a large number of clinical studies have been performed over the past decade targeting some of the postulated mechanisms of RI. These clinical studies were based on experimental data demonstrating significant myocardial salvage. Nevertheless, clinical benefits were absent or very limited. The purpose of this review is to provide an overview of the various strategies that inhibit RI and to discuss potential mechanisms that may contribute to the discrepancy between the promising pre-clinical data and the rather disappointing results obtained from prospective clinical trials. There are numerous differences between the experimental models and clinical studies, including the fact that experimental studies typically use abrupt occlusion and reperfusion protocols in animals with previously healthy myocardium that apparently do not predict the therapeutic efficacy of novel cardioprotective agents in a clinical setting with pre-existing progressive coronary disease, intermittent coronary occlusion, and relatively late reperfusion. However, discrepancies also exist between experimental studies. Future experimental studies of reperfusion injury should use models that mimic the clinical situation more closely. Furthermore, future large clinical trials should only be performed in cases where the drug under investigation proved to reduce RI in a series of well-designed (possibly multicenter) experimental studies and in clinical trials with predefined subgroups.

  2. Experimental search for quantum gravity

    CERN Document Server

    2018-01-01

    This book summarizes recent developments in the research area of quantum gravity phenomenology. A series of short and nontechnical essays lays out the prospects of various experimental possibilities and their current status. Finding observational evidence for the quantization of space-time was long thought impossible. In the last decade however, new experimental design and technological advances have changed the research landscape and opened new perspectives on quantum gravity. Formerly dominated by purely theoretical constructions, quantum gravity now has a lively phenomenology to offer. From high precision measurements using macroscopic quantum oscillators to new analysis methods of the cosmic microwave background, no stone is being left unturned in the experimental search for quantum gravity. This book sheds new light on the connection of astroparticle physics with the quantum gravity problem. Gravitational waves and their detection are covered. It illustrates findings from the interconnection between gene...

  3. 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.

  4. Design approaches to experimental mediation.

    Science.gov (United States)

    Pirlott, Angela G; MacKinnon, David P

    2016-09-01

    Identifying causal mechanisms has become a cornerstone of experimental social psychology, and editors in top social psychology journals champion the use of mediation methods, particularly innovative ones when possible (e.g. Halberstadt, 2010, Smith, 2012). Commonly, studies in experimental social psychology randomly assign participants to levels of the independent variable and measure the mediating and dependent variables, and the mediator is assumed to causally affect the dependent variable. However, participants are not randomly assigned to levels of the mediating variable(s), i.e., the relationship between the mediating and dependent variables is correlational. Although researchers likely know that correlational studies pose a risk of confounding, this problem seems forgotten when thinking about experimental designs randomly assigning participants to levels of the independent variable and measuring the mediator (i.e., "measurement-of-mediation" designs). Experimentally manipulating the mediator provides an approach to solving these problems, yet these methods contain their own set of challenges (e.g., Bullock, Green, & Ha, 2010). We describe types of experimental manipulations targeting the mediator (manipulations demonstrating a causal effect of the mediator on the dependent variable and manipulations targeting the strength of the causal effect of the mediator) and types of experimental designs (double randomization, concurrent double randomization, and parallel), provide published examples of the designs, and discuss the strengths and challenges of each design. Therefore, the goals of this paper include providing a practical guide to manipulation-of-mediator designs in light of their challenges and encouraging researchers to use more rigorous approaches to mediation because manipulation-of-mediator designs strengthen the ability to infer causality of the mediating variable on the dependent variable.

  5. Experimental application of QCD antennas

    Energy Technology Data Exchange (ETDEWEB)

    Bobrovskyi, Sergei

    2010-02-15

    A serious problem in searches for new physics at the LHC is the rejection of QCD induced multijet events. In this thesis the formalism of QCD antenna variables based on the SPHEL approximation of QCD matrix elements is applied for the rst time on experimentally reconstructed jets in order to discriminate QCD from supersymmetric processes. The new observables provide additional information with respect to traditional event shape variables. Albeit correlated with experimentally measured missing transverse energy, the variables can be used to improve the signal to background ratio. (orig.)

  6. Experimentation and Bricolage on Institutions

    DEFF Research Database (Denmark)

    Cartel, Melodie; Boxenbaum, Eva; Aggeri, Franck

    This paper examines how innovative institutional arrangements are generated during processes of institutional bricolage. The aim of the paper is to highlight how an arrangement is selected among the others when many alternatives exist or are imaginable. To address this question, we present...... a qualitative study of institutional bricolage in the context of the making of the European carbon market. We suggest that, during episodes of experimental bricolage, alternative arrangements may be tested and evaluated inside experimental spaces named platforms. We identify three selection mechanisms...

  7. Qualitative tools and experimental philosophy

    Science.gov (United States)

    Andow, James

    2016-01-01

    Abstract Experimental philosophy brings empirical methods to philosophy. These methods are used to probe how people think about philosophically interesting things such as knowledge, morality, and freedom. This paper explores the contribution that qualitative methods have to make in this enterprise. I argue that qualitative methods have the potential to make a much greater contribution than they have so far. Along the way, I acknowledge a few types of resistance that proponents of qualitative methods in experimental philosophy might encounter, and provide reasons to think they are ill-founded. PMID:28392629

  8. Potential Pitfalls of Experimental Design

    OpenAIRE

    Phillip Watkins

    2017-01-01

    Good experimental design begins with the end in mind. An early conversation with a statistician will both increase the chances of an experimental study contributing to the literature and minimize the risks to participating human subjects.  Sir R.A. Fisher felt that “to consult the statistician after an experiment is finished is often merely to ask him to conduct a post mortem examination: he can perhaps say what the experiment died of.” To this end, some questions from a statistician are pres...

  9. EXPERIMENTAL LIPOSOMAL VIRAL VACCINE SAFETY

    Directory of Open Access Journals (Sweden)

    Romanova OA

    2016-12-01

    Full Text Available Introduction. With the transport links development there is rather important issue respiratory viral infections spread, especially influenza. The only method controlling influenza is vaccination. Search and development effective and safe vaccines is important. Material and methods. In base SO "Mechnikov Institute Microbiology and Immunology National Ukrainian Academy Medical Sciences" in the scientific theme "Developing new approaches to creating viral vaccines and study specific activity depending of type and degree component`s modification" was created several experimental influenza vaccine with subsequent component`s modification for selecting the most optimal pattern of safety and immunogenicity. In assessing the influenza vaccine safety is using a few criteria, including, reactivity, as measured by the frequency of local and systemic adverse (negative effects, which due to its introduction, and for lipid content drugs, ability to influence oxidation processes. At present study phase was determined: a systemic reaction and local reaction of delayed-type hypersensitivity (foot pad swelling assay;b lipids and proteins peroxidation processes after administration officinal and experimental vaccines (content protein’s carbonyl groups, lipid’s hydroperoxides, activity of glutathione-peroxidase.Study objects were trivalent seasonal influenza vaccine, "Vaxigrip" (Sanofi Pasteur, S.A., France, "Inflexal V" (Biotech Ltd. Berne, Switzerland and experimental vaccine samples. Highest immunogenicity vaccines had undergone improvements and modifications using adjuvant systems and acylation influenza proteins. Liposomes 2 – the experimental influenza vaccine with a liposome negative charge and antigenic composition like split vaccines "Vaksihryp". Liposomes 2.1 - the adjuvantexperimental influenza vaccine with modifications liposomal components (etoniy and chlorophyllipt molecules embedded in liposomal membrane. Liposomes 2.2 - the adjuvant

  10. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010

    NARCIS (Netherlands)

    Califf, R.M.; Zarin, D.A.; Kramer, J.M.; Sherman, R.E.; Aberle, L.H.; Tasneem, A.

    2012-01-01

    CONTEXT: Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. Strengthened reporting requirements for studies registered with ClinicalTrials.gov enable a comprehensive evaluation of the national trials

  11. Pragmatic trial design elements showed a different impact on trial interpretation and feasibility than explanatory elements

    NARCIS (Netherlands)

    Nieuwenhuis, Joost B.; Irving, Elaine; Oude Rengerink, Katrien; Lloyd, Emily; Goetz, Iris; Grobbee, Diederick E.; Stolk, Pieter; Groenwold, Rolf H H; Zuidgeest, Mira G P

    2016-01-01

    OBJECTIVE: To illustrate how pragmatic trial design elements, or inserting explanatory trial elements in pragmatic trials affect validity, generalizability, precision and operational feasibility. STUDY DESIGN AND SETTING: From illustrative examples identified through the IMI Get Real Consortium, we

  12. Clinical trials. A pending subject.

    Science.gov (United States)

    Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

    2017-07-31

    Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  13. Need to improve clinical trials in rare neurodegenerative disorders.

    Science.gov (United States)

    Puopolo, Maria; Pocchiari, Maurizio

    2011-01-01

    Rare neurodegenerative diseases are fatal and no therapy is available to cure or slow down the progression of disease. We report possibly weaknesses in the management of clinical studies in these diseases, ranging from poor preclinical studies, difficulties in the recruitment of patients, delay in the onset of treatment because of lack in early disease-specific biomarkers, and suboptimal design of Phase II clinical trials. The adoption of innovative statistical approaches in early Phase II trials might improve the screening of drugs in rare neurodegenerative disorders, but this implicates efforts from clinical researchers, statisticians, and regulatory people to the development of new strategies that should maintain rigorous scientific integrity together with a more ethical approach to human experimentations.

  14. Need to improve clinical trials in rare neurodegenerative disorders

    Directory of Open Access Journals (Sweden)

    Maria Puopolo

    2011-01-01

    Full Text Available Rare neurodegenerative diseases are fatal and no therapy is available to cure or slow down the progression of disease. We report possibly weaknesses in the management of clinical studies in these diseases, ranging from poor preclinical studies, difficulties in the recruitment of patients, delay in the onset of treatment because of lack in early disease-specific biomarkers, and suboptimal design of Phase II clinical trials. The adoption of innovative statistical approaches in early Phase II trials might improve the screening of drugs in rare neurodegenerative disorders, but this implicates efforts from clinical researchers, statisticians, and regulatory people to the development of new strategies that should maintain rigorous scientific integrity together with a more ethical approach to human experimentations.

  15. 76 FR 48119 - Oral Rabies Vaccine Trial; Availability of a Risk Assessment and an Environmental Assessment

    Science.gov (United States)

    2011-08-08

    ... Animal and Plant Health Inspection Service Oral Rabies Vaccine Trial; Availability of a Risk Assessment... prepared to assess the risks associated with an experimental rabies vaccine, analyzes the use of that... evaluate a wildlife rabies vaccine that will produce sufficient levels of population immunity in raccoons...

  16. Insights from full-rotation Nelder spacing trials with Eucalyptus in ...

    African Journals Online (AJOL)

    Insights from full-rotation Nelder spacing trials with Eucalyptus in São Paulo, Brazil. ... The choice of spacing among trees for operational plantations is typically based on one or more experimental plantations that test for the response of tree and stand growth to a range of tree-to-tree distances. The most common design for ...

  17. 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…

  18. A variational approach to determine the optimal power distribution for cycling in a time trial

    NARCIS (Netherlands)

    de Jong, J.; Fokkink, R.J.; Olsder, G.J.; Schwab, A.L.; van der Helm, F.C.T.; Jansen, A.J.

    2016-01-01

    The optimal pacing strategy of a cyclist in an individual time-trial depends on terrain, weather conditions and the cyclists endurance capacity. Previous experimental and theoretical studies have shown that a suboptimal pacing strategy may have a substantial negative effect. In this paper we

  19. Frederick National Lab Supports Clinical Trials for Vaccine Against Mosquito-borne Chikungunya | FNLCR

    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

  20. 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