WorldWideScience

Sample records for controlled field trial

  1. Contamination control and revegetation (Field trials)

    International Nuclear Information System (INIS)

    Robison, William L.; Stone, Earl L.

    1986-01-01

    The LLNL/DOE field program at Bikini Atoll began in 1977. The first few years were devoted to developing an adequate data base from which to do an updated dose assessment of Bikini and Eneu Islands. The results indicated that 137 Cs was the most significant radionuclide, actually accounting for more than 90% of the total estimated wholebody and bone marrow dose, and that the terrestrial food chain (especially coconut) was the most significant potential exposure pathway. Strontium-90 accounts for only about 507% of the total bone marrow dose and the transuranics, 239+240 Pu and 241 Am, less than 1%. Thus, if the intake of 137 Cs can be reduced to 10% or less of its current concentration in food crops the radiological dose for Bikini Island would be within federal guidelines. However, samples of vegetation and soil will be analyzed for Sr and the transuranics to ensure an adequate data for evaluation of these radionuclide. In 1980, prior to the formation of the BARC, the goals of our Marshall Island program were extended to include an initial evaluation of methods to reduce the uptake of 137 Cs by food crops and/or reduce the 137 Cs soil inventory. We expanded one of our experiments and added two more when the BARC was formed and additional funding became available for evaluating the rehabilitation of Bikini Atoll

  2. Mindfulness Training and Reductions in Teacher Stress and Burnout: Results from Two Randomized, Waitlist-Control Field Trials

    Science.gov (United States)

    Roeser, Robert W.; Schonert-Reichl, Kimberly A.; Jha, Amishi; Cullen, Margaret; Wallace, Linda; Wilensky, Rona; Oberle, Eva; Thomson, Kimberly; Taylor, Cynthia; Harrison, Jessica

    2013-01-01

    The effects of randomization to mindfulness training (MT) or to a waitlist-control condition on psychological and physiological indicators of teachers' occupational stress and burnout were examined in 2 field trials. The sample included 113 elementary and secondary school teachers (89% female) from Canada and the United States. Measures were…

  3. Impact of weed control strategies on resistance evolution in Alopecurus myosuroides – a long-term field trial

    Directory of Open Access Journals (Sweden)

    Ulber, Lena

    2016-02-01

    Full Text Available The impact of various herbicide strategies on populations of Alopecurus myosuroides is investigated in a longterm field trial situated in Wendhausen (Germany since 2009. In the initial years of the field experiment, resistant populations were selected by means of repeated application of the same herbicide active ingredients. For the selection of different resistance profiles, herbicides with actives from different HRAC groups were used. The herbicide actives flupyrsulfuron, isoproturon und fenoxaprop-P were applied for two years on large plots. In a succeeding field trial starting in 2011, it was investigated if the now existing resistant field populations could be controlled by various herbicide strategies. Eight different strategies consisting of various herbicide combinations were tested. Resistance evolution was investigated by means of plant counts and molecular genetic analysis.

  4. Field efficacy of expanded polystyrene and shredded waste polystyrene beads for mosquito control in artificial pools and field trials, Islamic Republic of Iran.

    Science.gov (United States)

    Soltani, A; Vatandoost, H; Jabbari, H; Mesdaghinia, A R; Mahvi, A H; Younesian, M; Hanafi-Bojd, A A; Bozorgzadeh, S

    2012-10-01

    Concerns about traditional chemical pesticides has led to increasing research into novel mosquito control methods. This study compared the effectiveness of 2 different types of polystyrene beads for control of mosquito larvae in south-east Islamic Republic of Iran. Simulated field trials were done in artificial pools and field trials were carried out in 2 villages in an indigenous malaria area using WHO-recommended methods. Application of expanded polystyrene beads or shredded, waste polystyrene chips to pool surfaces produced a significant difference between pre-treatment and post-treatment density of mosquitoes (86% and 78% reduction respectively 2 weeks after treatment). There was no significant difference between the efficacy of the 2 types of material. The use of polystyrene beads as a component of integrated vector management with other supportive measures could assist in the control of mosquito-borne diseases in the Islamic Republic of Iran and neighbouring countries.

  5. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

    Directory of Open Access Journals (Sweden)

    Poeze Martijn

    2011-05-01

    Full Text Available Abstract Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%, non-union (5-21% and early osteo-arthritis (up to 32% which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning. Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation

  6. Field trial of a synthetic tsetse-repellent technology developed for the control of bovine trypanosomosis in Kenya.

    Science.gov (United States)

    Bett, B; Randolph, T F; Irungu, P; Nyamwaro, S O; Kitala, P; Gathuma, J; Grace, D; Vale, G; Hargrove, J; McDermott, J

    2010-12-01

    We conducted a field trial among Maasai cattle-keepers in Nkuruman and Nkineji areas of Kenya to evaluate the effectiveness of a synthetic tsetse-repellent technology developed for the control of trypanosomosis in cattle. The technology was a repellent (2-methoxy 4-methylphenol) emitted from dispensers attached to collars worn by cattle. Treatment was allocated at the herd level to ensure adequate protection of all the animals in a herd, with measurements of effectiveness conducted at the individual-animal level. The trial began in April 2005 and ran for 16 months including a baseline phase of 4 months. We recruited 12 herds in each area using a restricted random-sampling technique and distributed them equally into intervention (repellent) and control groups. Sample size was determined using a formal power calculation. Effectiveness or minimal worthwhile difference was defined as a 50% reduction in the incidence of trypanosome infection in the treated versus control group (effectiveness below which the technology was considered by experts as not viable compared to existing control techniques). All the animals in the recruited herds were screened monthly (buffy-coat technique) for trypanosome infections. The analysis followed the principle of intention-to-treat by which subjects are analysed according to their initial treatment assignment, regardless of the mechanical performance of the device. Crude and adjusted effects of the technology were 23% (ptechnology estimated in this study did not achieve the threshold of 50% reduction in the trypanosome infection incidence set a priori to indicate effectiveness (ptechnology package was not sufficiently effective in reducing trypanosome infection incidence under natural tsetse challenge to merit commercial development. Copyright © 2010 Elsevier B.V. All rights reserved.

  7. Differentiation of organic and non-organic winter wheat cultivars from a controlled field trial by crystallization patterns.

    Science.gov (United States)

    Kahl, Johannes; Busscher, Nicolaas; Mergardt, Gaby; Mäder, Paul; Torp, Torfinn; Ploeger, Angelika

    2015-01-01

    There is a need for authentication tools in order to verify the existing certification system. Recently, markers for analytical authentication of organic products were evaluated. Herein, crystallization with additives was described as an interesting fingerprint approach which needs further evidence, based on a standardized method and well-documented sample origin. The fingerprint of wheat cultivars from a controlled field trial is generated from structure analysis variables of crystal patterns. Method performance was tested on factors such as crystallization chamber, day of experiment and region of interest of the patterns. Two different organic treatments and two different treatments of the non-organic regime can be grouped together in each of three consecutive seasons. When the k-nearest-neighbor classification method was applied, approximately 84% of Runal samples and 95% of Titlis samples were classified correctly into organic and non-organic origin using cross-validation. Crystallization with additive offers an interesting complementary fingerprint method for organic wheat samples. When the method is applied to winter wheat from the DOK trial, organic and non-organic treated samples can be differentiated significantly based on pattern recognition. Therefore crystallization with additives seems to be a promising tool in organic wheat authentication. © 2014 Society of Chemical Industry.

  8. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial.

    Science.gov (United States)

    Hannemann, Pascal; Göttgens, Kevin W A; van Wely, Bob J; Kolkman, Karel A; Werre, Andries J; Poeze, Martijn; Brink, Peter R G

    2011-05-06

    The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences.Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning).Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory.Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional

  9. Entomopathogenic nematodes for the control of the codling moth (Cydia pomonella L.) in field and laboratory trials.

    Science.gov (United States)

    Odendaal, D; Addison, M F; Malan, A P

    2016-09-01

    Three commercially available entomopathogenic nematode (EPN) strains (Steinernema feltiae and Heterorhabditis bacteriophora Hb1 and Hb2) and two local species (S. jeffreyense and S. yirgalemense) were evaluated for the control of the codling moth (Cydia pomonella). In field spray trials, the use of S. jeffreyense resulted in the most effective control (67%), followed by H. bacteriophora (Hb1) (42%) and S. yirgalemense (41%). Laboratory bioassays using spray application in simulated field conditions indicate S. feltiae to be the most virulent (67%), followed by S. yirgalemense (58%). A laboratory comparison of the infection and penetration rate of the different strains showed that, at 14°C, all EPN strains resulted in slower codling moth mortality than they did at 25°C. After 48 h, 98% mortality was recorded for all species involved. However, the washed codling moth larvae, cool-treated (at 14°C) with S. feltiae or S. yirgalemense, resulted in 100% mortality 24 h later at room temperature, whereas codling moth larvae treated with the two H. bacteriophora strains resulted in 68% and 54% control, respectively. At 14°C, S. feltiae had the highest average penetration rate of 20 IJs/larva, followed by S. yirgalemense, with 14 IJs/larva. At 25°C, S. yirgalemense had the highest penetration rate, with 39 IJs/larva, followed by S. feltiae, with 9 IJs/larva. This study highlights the biocontrol potential of S. jeffreyense, as well as confirming that S. feltiae is a cold-active nematode, whereas the other three EPN isolates tested prefer warmer temperatures.

  10. Commentary: Randomized controlled trials in autism spectrum disorder: state of the field and challenges for the future.

    Science.gov (United States)

    Simonoff, Emily

    2018-04-01

    This issue of the Journal includes two articles summarizing the evidence from clinical trials aimed at improving symptoms of autism. French and Kennedy (Journal of Child Psychology and Psychiatry, 2018, xx, xxxx) systematically review randomized controlled trials (RCTs) aimed at an "early intervention" and focus on trials including children with or at risk of autism under age 6 years. Although no type of intervention were excluded from their review, none of the included 48 RCTs employed pharmacological modalities and the overwhelming majority tested psychological/behavioural interventions aimed at modifying aspects of observed behaviours that are abnormal in children with autism. Using the standard Cochrane tool for evaluating risk of bias, French and Kennedy conclude that many RCTs are of low quality, which throws into question the reliance that should be placed on the findings. © 2018 Association for Child and Adolescent Mental Health.

  11. A cluster randomized control field trial of the ABRACADABRA web-based literacy intervention: Replication and extension of basic findings.

    Directory of Open Access Journals (Sweden)

    Noella Angele Piquette

    2014-12-01

    Full Text Available The present paper reports a cluster randomized control trial evaluation of teaching using ABRACADABRA (ABRA, an evidence-based and web-based literacy intervention (http://abralite.concordia.ca with 107 kindergarten and 96 grade 1 children in 24 classes (12 intervention 12 control classes from all 12 elementary schools in one school district in Canada. Children in the intervention condition received 10-12 hours of whole class instruction using ABRA between pre- and post-test. Hierarchical linear modeling of post-test results showed significant gains in letter-sound knowledge for intervention classrooms over control classrooms. In addition, medium effect sizes were evident for three of five outcome measures favoring the intervention: letter-sound knowledge (d = +.66, phonological blending (d = +.52, and word reading (d = +.52, over effect sizes for regular teaching. It is concluded that regular teaching with ABRA technology adds significantly to literacy in the early elementary years.

  12. Field trials in South China to control the diamondback moth, Plutella xylostella (Lepidoptera: Plutellidae) using radiation-induced sterility

    International Nuclear Information System (INIS)

    Yang, R.; Xia, D.; Gu, W.; Zhang, Y.

    2002-01-01

    This paper discusses the control of the diamondback moth, Plutella xylostella by the sterile insect technique (SIT). Our studies included mating characteristics, sterility of the F 1 generation, dispersal and recapture of irradiated moths, as well as control of DBM using SIT and F 1 sterility, and an economic evaluation of F 1 sterility to protect cabbage. Male DBM mated an average of 16 times and female DBM mated an average of 4 times. However, irradiated male DBM only mated an average of 7.2 times. Seventy percent of matings occurred from 18:00-24:00 h with an average duration of 80 min. Irradiated male moths and untreated male moths exhibited the same attraction to female moths. After 10 days, most (94.2%) of the released, sterile DBM were recaptured within 40 m of the release site. Only one DBM was recaptured at 120 m from the release site. The area of dispersal was calculated to be 696 m 2 during the first three days. In a field study to control DBM by releases of irradiated insects, the ratio of sterile to wild DBM was 4.7:1. During this study, the egg sterility in the F 1 and F 2 generations was 79.0% and 81.7%, respectively. The developmental times for the F 1 and F 2 generations were 4 and 12 days longer, respectively, than for DBM in the control area. Thus, the number of DBM generations was reduced in the treated field. With successive releases over two generations, the control effectiveness was 80.8% in the F 1 generation and 79.1% in the F 2 generation. The cost of using F 1 sterility to control DBM in a small field was similar to the cost of using pesticides. Therefore, the use of F 1 sterility should be an economically viable control strategy for DBM that also would help protect the environment from the overuse of pesticides. (author)

  13. Field trials at Bikini Atoll

    International Nuclear Information System (INIS)

    Robison, William L.; Stone, Earl L.

    1987-01-01

    Last year's report summarized the status of both the long on-going soil and plant sampling programs (initiated by LLNL in 1978) and the field experiments aimed at reducing radionuclide levels in food plants to acceptable levels. In the current report the two are combined into a single summary table, indicating for each field trial or survey the results to date, information expected by the spring of 1988, and projection, if any, for continuation beyond FY1988. This table is therefore a comprehensive survey of the program and accordingly the individual items in it have been coded to facilitate reference to them. Analytical results from field studies installed in 1985 and 1986 are now providing much new information, briefly described below. In part, these results bear out or enlarge the hypotheses that prompted the studies. They also suggest how some treatments may be modified or combined for greater effectiveness. We shall discuss here certain groups of studies of immediate interest that deal with the blocking effects of potassium and other ions on cesium-137 uptake by plants, the effect of removing topsoil (excavation), cultural studies which involve the manipulation of the subsoil, plus some others

  14. Field trials at Bikini Atoll

    Energy Technology Data Exchange (ETDEWEB)

    Robison, William L [Lawrence Livermore National Laboratory, Environmental Sciences Division, Livermore, CA (United States); Stone, Earl L [University of Florida, Soil Science Department, Gainesville, FL (United States)

    1987-07-01

    Last year's report summarized the status of both the long on-going soil and plant sampling programs (initiated by LLNL in 1978) and the field experiments aimed at reducing radionuclide levels in food plants to acceptable levels. In the current report the two are combined into a single summary table, indicating for each field trial or survey the results to date, information expected by the spring of 1988, and projection, if any, for continuation beyond FY1988. This table is therefore a comprehensive survey of the program and accordingly the individual items in it have been coded to facilitate reference to them. Analytical results from field studies installed in 1985 and 1986 are now providing much new information, briefly described below. In part, these results bear out or enlarge the hypotheses that prompted the studies. They also suggest how some treatments may be modified or combined for greater effectiveness. We shall discuss here certain groups of studies of immediate interest that deal with the blocking effects of potassium and other ions on cesium-137 uptake by plants, the effect of removing topsoil (excavation), cultural studies which involve the manipulation of the subsoil, plus some others.

  15. A literature review of applied adaptive design methodology within the field of oncology in randomised controlled trials and a proposed extension to the CONSORT guidelines.

    Science.gov (United States)

    Mistry, Pankaj; Dunn, Janet A; Marshall, Andrea

    2017-07-18

    The application of adaptive design methodology within a clinical trial setting is becoming increasingly popular. However the application of these methods within trials is not being reported as adaptive designs hence making it more difficult to capture the emerging use of these designs. Within this review, we aim to understand how adaptive design methodology is being reported, whether these methods are explicitly stated as an 'adaptive design' or if it has to be inferred and to identify whether these methods are applied prospectively or concurrently. Three databases; Embase, Ovid and PubMed were chosen to conduct the literature search. The inclusion criteria for the review were phase II, phase III and phase II/III randomised controlled trials within the field of Oncology that published trial results in 2015. A variety of search terms related to adaptive designs were used. A total of 734 results were identified, after screening 54 were eligible. Adaptive designs were more commonly applied in phase III confirmatory trials. The majority of the papers performed an interim analysis, which included some sort of stopping criteria. Additionally only two papers explicitly stated the term 'adaptive design' and therefore for most of the papers, it had to be inferred that adaptive methods was applied. Sixty-five applications of adaptive design methods were applied, from which the most common method was an adaptation using group sequential methods. This review indicated that the reporting of adaptive design methodology within clinical trials needs improving. The proposed extension to the current CONSORT 2010 guidelines could help capture adaptive design methods. Furthermore provide an essential aid to those involved with clinical trials.

  16. IAEA monitoring field trials workshop

    International Nuclear Information System (INIS)

    Ross, H.H.; Cooley, J.N.; Belew, W.L.

    1995-01-01

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

  17. Alien wavelength modeling tool and field trial

    DEFF Research Database (Denmark)

    Sambo, N.; Sgambelluri, A.; Secondini, M.

    2015-01-01

    A modeling tool is presented for pre-FEC BER estimation of PM-QPSK alien wavelength signals. A field trial is demonstrated and used as validation of the tool's correctness. A very close correspondence between the performance of the field trial and the one predicted by the modeling tool has been...

  18. 167: CRITICALLY APPRAISE OF THE REPORTING QUALITY OF RANDOMIZED CONTROLLED TRIALS ARTICLES IN THE FIELD OF DIABETES IN MEDICAL GUIDELINES IN IRAN

    Science.gov (United States)

    Aletaha, Azadeh; Baradaran, Hamid Reza; Soltani, Akbar; Ramezani, Amir

    2017-01-01

    Background and aims To determine the quality of randomized controlled clinical trial reports in diabetes research in Iran and their presence in domestic and foreign credible guidelines which can imply whether randomized controlled trial articles in the field of diabetes are of good quality or not with respect to their high level of received citations, quality and credibility. Method We included RCTs conducted on Diabetes mellitus in Iran. Animal studies, educational, interventions, and non-randomized trials were excluded. This was a bibliographic study examining published journal articles involving RCTs in diabetes research from Iranian authors. A systematic search of ten databases(ISI Web of science, Scopus, PubMed, Science Direct, The Cochrane Library, Taylor & Francis Online, Biomed Central, EBSCO, ProQuest and OVID)were undertaken from July 2004–2014. We excluded duplicated publications reporting the same groups of participants and intervention two independent reviewers identify all eligible articles specifically designed data extraction form. Two reviewers assessed the quality of reporting by CONSORT 2010 (Consolidated Standards of Reporting Trials) checklist statement and also evaluate each article with Scientometry tools in 260 valid English diabetes guidelines. Result Overall, we included 185 RCTs on diabetes mellitus, One hundred and eight five (185) studies were included and appraised. Half of them (55.7%) were published in Iranian journals. Most (89.7%) were parallel RCTs, and being performed on type2 diabetic patients (77.8%). Less than half of the CONSORT items (43.2%) were reported in studies, totally. The reporting of randomization and blinding were poor. A few studies 15.1% mentioned the method of random sequence generation and strategy of allocation concealment. And only 34.8% of trials report how blinding was applied. From 185 articles, twelve articles (10%) are presented in 260 Guidelines. Conclusion The reporting quality of abstracts of RCTs

  19. Static magnetic field therapy for symptomatic diabetic neuropathy: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Weintraub, Michael I; Wolfe, Gil I; Barohn, Richard A; Cole, Steven P; Parry, Gareth J; Hayat, Ghazala; Cohen, Jeffrey A; Page, Jeffrey C; Bromberg, Mark B; Schwartz, Sherwyn L

    2003-05-01

    To determine if constant wearing of multipolar, static magnetic (450G) shoe insoles can reduce neuropathic pain and quality of life (QOL) scores in symptomatic diabetic peripheral neuropathy (DPN). Randomized, placebo-control, parallel study. Forty-eight centers in 27 states. Three hundred seventy-five subjects with DPN stage II or III were randomly assigned to wear constantly magnetized insoles for 4 months; the placebo group wore similar, unmagnetized device. Nerve conduction and/or quantified sensory testing were performed serially. Daily visual analog scale scores for numbness or tingling and burning and QOL issues were tabulated over 4 months. Secondary measures included nerve conduction changes, role of placebo, and safety issues. Analysis of variance (ANOVA), analysis of covariance (ANCOVA), and chi-square analysis were performed. There were statistically significant reductions during the third and fourth months in burning (mean change for magnet treatment, -12%; for sham, -3%; P<.05, ANCOVA), numbness and tingling (magnet, -10%; sham, +1%; P<.05, ANCOVA), and exercise-induced foot pain (magnet, -12%; sham, -4%; P<.05, ANCOVA). For a subset of patients with baseline severe pain, statistically significant reductions occurred from baseline through the fourth month in numbness and tingling (magnet, -32%; sham, -14%; P<.01, ANOVA) and foot pain (magnet, -41%; sham, -21%; P<.01, ANOVA). Static magnetic fields can penetrate up to 20mm and appear to target the ectopic firing nociceptors in the epidermis and dermis. Analgesic benefits were achieved over time.

  20. Solid oxide fuel cell field trial evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Wilcox, C.P.; Winstanley, R.; Nietsch, T.; Smith, C.; Knight, R.; Seymore, C.

    2000-07-01

    This report focuses on issues relating to a field trial of a solid oxide fuel cell (SOFC). Aspects examined include markets for SOFC systems, the choice of systems for demonstration in year 2002, the assessment of industrial interest, and evaluation and ranking of candidate systems. The identification and evaluation of interest in field trials, the estimation of the capital and running costs of a field trial, and identification of the benefits to the UK and barriers to implementation of SOFC systems are discussed. (UK)

  1. Visual field protective effect of Erigeron breviscapus (vant.) Hand. Mazz. extract on glaucoma with controlled intraocular pressure: a randomized, double-blind, clinical trial.

    Science.gov (United States)

    Zhong, Yisheng; Xiang, Minhong; Ye, Wen; Cheng, Yu; Jiang, Youqin

    2010-01-01

    To evaluate the visual field protective effect of Erigeron breviscapus (vant.) Hand. Mazz. (EBHM) extract on glaucoma with controlled intraocular pressure (IOP). Forty patients (40 eyes) with primary open-angle glaucoma, visual field defects and a postsurgical IOP of <18 mmHg were enrolled. The EBHM and placebo tablets were given orally according to the randomized and double-blind principle. Two tablets (of either EBHM or placebo) were taken three times a day for a period of 6 months. Patients were examined every 2 months after treatment commenced. At the end of the study, the results were given to the drug manufacturer. All patients completed the prospective, randomized, double-blind, clinical trial. No obvious adverse effects were found in patients during the treatment period. In the placebo group, no significant difference was found in mean defect (MD) or mean sensitivity (MS) between the values at pre-treatment and after 2, 4, and 6 months of treatment. After 6 months of EBHM treatment, the MD was significantly decreased and the MS was significantly increased compared with pre-treatment (p < 0.05). In the patients with moderate and late glaucoma, the MD was significantly decreased and the MS was significantly increased after 2, 4, and 6 months of EBHM treatment compared with pre-treatment. EBHM extract may have a partial protective effect on the visual field of glaucoma patients with controlled IOP. Further studies are needed to determine the safety and effectiveness of long-term EBHM treatment.

  2. Soil stabilization field trial : interim report II.

    Science.gov (United States)

    2002-02-01

    Shrinkage cracks in cement-stabilized bases/subbase can be alleviated by specifying the right cement dosage, or by other additives/procedures that suppress crack susceptibility. A field trial of six 1000 ft sections to investigate several alternative...

  3. Field assessment of a novel household-based water filtration device: a randomised, placebo-controlled trial in the Democratic Republic of Congo.

    Science.gov (United States)

    Boisson, Sophie; Kiyombo, Mbela; Sthreshley, Larry; Tumba, Saturnin; Makambo, Jacques; Clasen, Thomas

    2010-09-10

    Household water treatment can improve the microbiological quality of drinking water and may prevent diarrheal diseases. However, current methods of treating water at home have certain shortcomings, and there is evidence of bias in the reported health impact of the intervention in open trial designs. We undertook a randomised, double-blinded, placebo-controlled trial among 240 households (1,144 persons) in rural Democratic Republic of Congo to assess the field performance, use and effectiveness of a novel filtration device in preventing diarrhea. Households were followed up monthly for 12 months. Filters and placebos were monitored for longevity and for microbiological performance by comparing thermotolerant coliform (TTC) levels in influent and effluent water samples. Mean longitudinal prevalence of diarrhea was estimated among participants of all ages. Compliance was assessed through self-reported use and presence of water in the top vessel of the device at the time of visit. Over the 12-month follow-up period, data were collected for 11,236 person-weeks of observation (81.8% total possible). After adjusting for clustering within the household, the longitudinal prevalence ratio of diarrhoea was 0.85 (95% confidence interval: 0.61-1.20). The filters achieved a 2.98 log reduction in TTC levels while, for reasons that are unclear, the placebos achieved a 1.05 log reduction (pwater the previous day. The filter maintained a constant flow rate over time, though 12.4% of filters were damaged during the course of the study. While the filter was effective in improving water quality, our results provide little evidence that it was protective against diarrhea. The moderate reduction observed nevertheless supports the need for larger studies that measure impact against a neutral placebo. Current Controlled Trials ISRCTN03844341.

  4. Field trials for the control of the Mediterranean fruit-fly by radiation induced sterility. Part of a coordinated programme on fruit-fly eradication of control by the sterile-male technique

    International Nuclear Information System (INIS)

    Mellado, L.; Arroyo, M.; Jimenez, A.; Ros, P.; Caballero, F.; Vargas, C.

    1975-12-01

    More than 50 million insects were used in field trials in which the applicability of the sterile insects release method to the control of Ceratitis capitata in Spain was tested. The areas concerned were Santa Fe, Purchil and Armilla. Whereas the infestation of untreated areas (controls) was 92 %, chemically treated areas (using Lebaycid and other insecticides) ranged from 1.2 to 17 %, and areas over which sterile insects had been released showed less than 1.3 % infestation. The economic aspects and advantages of the sterile insect method compared with chemical control measures are pointed out

  5. Assessing the usefulness of mineral licks containing herbal extracts with anti-parasitic properties for the control of gastrointestinal helminths in grazing sheep – a field trial

    Directory of Open Access Journals (Sweden)

    Nosal P.

    2016-06-01

    Full Text Available One of the alternative methods of parasite control, of particular importance in sustainable farming, is the use of medicinal plants. The specific aim of the present field trial was to assess the anti-parasitic effects of herbal extracts contained in a commercially available lick formulation for sheep. At the outset of this study conducted during the grazing season, all animals were de-wormed and then randomly assigned to one of the two separately kept groups (treatment and control, each consisting of 25 animals (11 ewes and 14 lambs. The treatment group received mineral licks containing the extracts of the plants with anti-parasitic properties, while control animals received standard mineral licks ad libitum. Rectal fecal samples were collected monthly from all animals for the McMaster analyses. There were no significant differences in the prevalence and intensity of helminth infections between the treatment and control groups. Thus, we were not able to ascertain the efficacy of the commercial herbal de-wormer tested for the control of gastrointestinal helminths in grazing ewes and their lambs.

  6. Controlling magnetic field profiles

    International Nuclear Information System (INIS)

    Freeman, J.R.

    1979-04-01

    A method for designing solenoid magnets with controlled field profiles is discussed. The method, originated by D.B. Montgomery, minimizes both the field errors and the power consumption. An NOS time-sharing computer program for the CDC-6600, entitled MAGCOR, was constructed to provide an interactive magnet design capability. Results obtained during the design of magnets for a radial line electron accelerator are presented. 9 figures

  7. Microbial control of emerald ash borer, Agrilus planipennis (Coleoptera: Buprestidae) with Beauveria bassiana strain GHA: Greenhouse and field trials

    Science.gov (United States)

    Houping Liu; Leah S. Bauer

    2008-01-01

    In 2003-2004, the lethal and sublethal effects of Beauveria bassiana strain GHA on emerald ash borer, Agrilus planipennis (Coleoptera: Buprestidae) adults and larvae were evaluated using topical spray and fungal band treatments in the greenhouse and field. B. bassiana strain GHA was moderately effective against...

  8. Acute peripheral joint injury: cost and effectiveness of low-field-strength MR imaging--results of randomized controlled trial.

    NARCIS (Netherlands)

    Nikken, J.J.; Oei, E.H.; Ginai, A.Z.; Krestin, G.P.; Verhaar, J.A.N.; Vugt, A.B. van; Hunink, M.G.M.

    2005-01-01

    PURPOSE: To assess prospectively if a short imaging examination performed with low-field-strength dedicated magnetic resonance (MR) imaging in addition to radiography is effective and cost saving compared with the current diagnostic imaging strategy (radiography alone) in patients with recent acute

  9. Transcranial pulsed electromagnetic fields for multiple chemical sensitivity: Study protocol for a randomized, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Tran, Marie Thi Dao; Skovbjerg, Sine; Arendt-Nielsen, Lars

    2013-01-01

    . The symptoms may have severe impact on patients' lives, but an evidence-based treatment for the condition is nonexisting. The pathophysiology is unclarified, but several indicators point towards abnormal processing of sensory signals in the central nervous system. Pulsed electromagnetic fields (PEMF) offer...... follow-up according to a predefined timetable. The primary outcome will be a measurement of the impact of MCS on everyday life. The secondary outcomes will be measurements of MCS symptoms, psychological distress (stress, anxiety or depressive symptoms), capsaicin-induced secondary punctate hyperalgesia...

  10. The impact of an urban sewerage system on childhood diarrhoea in Tehran, Iran: a concurrent control field trial.

    Science.gov (United States)

    Kolahi, Ali-Asghar; Rastegarpour, Ali; Sohrabi, Mohammad-Reza

    2009-05-01

    The stepwise implementation of the Tehran Sewerage Project provided a convenient setting for which health impacts of an urban sewerage system could be examined with appropriate controls. In 2001, Tehran municipal districts 17 and 18 had no sewerage system connections, but areas within these districts had been planned to be connected by 2006. These areas were chosen as an intervention group. Neighbouring areas, with a similar socio-economic status, that had not been planned to connect to the sewerage system by 2006, were chosen as controls. Homes within designated areas were randomized and surveyed twice to determine diarrhoea incidences for children aged 6-60 months, once in 2001, before connection to the sewerage system, and once again in 2006, after the intervention. By 2006, 76% of the homes in the intervention zones were connected to the sewerage system. In the first stage of the study, diarrhoea incidences for intervention and control groups were 18.6 and 16.6%, respectively. In the second stage, incidences decreased to 10.1 and 10.5%, respectively. Data collected from 4179 children demonstrated that the diarrhoea incidence had decreased by 46% in the intervention group, whereas it had decreased by 37% in the controls.

  11. Effects of resource-building group intervention on career management and mental health in work organizations: randomized controlled field trial.

    Science.gov (United States)

    Vuori, Jukka; Toppinen-Tanner, Salla; Mutanen, Pertti

    2012-03-01

    A resource-building group intervention was developed to enhance career management, mental health, and job retention in work organizations. The in-company training program provided employees with better preparedness to manage their own careers. The program activities were universally implemented using an organization-level, 2-trainer model with trainers from the human resources management and occupational health services. The study was a within-organizations, randomly assigned field experimental study; it investigated the impacts of the intervention on immediate career management preparedness and later mental health and intentions to retire early. A total of 718 eligible individuals returned a questionnaire in 17 organizations and became voluntary participants. The respondents were randomly assigned to either an intervention (N = 369) or a comparison group (N = 349). Those in the intervention group were invited to group intervention workshops, whereas those in the comparison group received printed information about career and health-related issues. The 7-month follow-up results showed that the program significantly decreased depressive symptoms and intentions to retire early and increased mental resources among the group participants compared to the others. The mediation analyses demonstrated that the increase in career management preparedness as a proximal impact of the intervention mediated the longer term mental health effects. Those who benefited most from the intervention as regards their mental health were employees with elevated levels of depression or exhaustion and younger employees, implying additional benefits of a more targeted use of the intervention. The results demonstrated the benefits of the enhancement of individual-level career management and resilience resources as career and health promotion practice in work organizations.

  12. Photovoltaic domestic field trial. Third annual report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2005-07-01

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

  13. 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.

  14. Effects of Pulsed Electromagnetic Fields on Return to Sports After Arthroscopic Debridement and Microfracture of Osteochondral Talar Defects: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial.

    Science.gov (United States)

    Reilingh, Mikel L; van Bergen, Christiaan J A; Gerards, Rogier M; van Eekeren, Inge C; de Haan, Rob J; Sierevelt, Inger N; Kerkhoffs, Gino M M J; Krips, Rover; Meuffels, Duncan E; van Dijk, C N; Blankevoort, Leendert

    2016-05-01

    Osteochondral defects (OCDs) of the talus usually affect athletic patients. The primary surgical treatment consists of arthroscopic debridement and microfracture. Various possibilities have been suggested to improve the recovery process after debridement and microfracture. A potential solution to obtain this goal is the application of pulsed electromagnetic fields (PEMFs), which stimulate the repair process of bone and cartilage. The use of PEMFs after arthroscopic debridement and microfracture of an OCD of the talus leads to earlier resumption of sports and an increased number of patients that resume sports. Randomized controlled trial; Level of evidence, 1. A total of 68 patients were randomized to receive either PEMFs (n = 36) or placebo (n = 32) after arthroscopic treatment of an OCD of the talus. The primary outcomes (ie, the number of patients who resumed sports and time to resumption of sports) were analyzed with Kaplan-Meier curves as well as Mann-Whitney U, chi-square, and log-rank tests. Secondary functional outcomes were assessed with questionnaires (American Orthopaedic Foot and Ankle Society ankle-hindfoot score, Foot and Ankle Outcome Score, EuroQol, and numeric rating scales for pain and satisfaction) at multiple time points up to 1-year follow-up. To assess bone repair, computed tomography scans were obtained at 2 weeks and 1 year postoperatively. Almost all outcome measures improved significantly in both groups. The percentage of sport resumption (PEMF, 79%; placebo, 80%; P = .95) and median time to sport resumption (PEMF, 17 weeks; placebo, 16 weeks; P = .69) did not differ significantly between the treatment groups. Likewise, there were no significant between-group differences with regard to the secondary functional outcomes and the computed tomography results. PEMF does not lead to a higher percentage of patients who resume sports or to earlier resumption of sports after arthroscopic debridement and microfracture of talar OCDs. Furthermore, no

  15. Soil stabilization field trial : interim report III.

    Science.gov (United States)

    2003-11-01

    Shrinkage cracks in cement-stabilized bases/subbase can be alleviated by specifying the right cement dosage, or by other additives/procedures that suppress crack susceptibility. A field trial of six 1000 ft test sections to investigate several altern...

  16. Soil stabilization field trial : interim report.

    Science.gov (United States)

    2001-04-01

    Shrinkage cracks in cement-stabilized bases/subbase can be alleviated by specifying : the right cement dosage, or by other additives/procedures that suppress crack susceptibility. A field : trial of six 1000 ft test sections to investigate several al...

  17. Soil stabilization field trial : interim report I.

    Science.gov (United States)

    2001-04-01

    Shrinkage cracks in cement-stabilized bases/subbase can be alleviated by specifying the right cement dosage, or by other additives/procedures that suppress crack susceptibility. A field trial of six 1000 ft test sections to investigate several altern...

  18. Microwave bale moisture sensing: Field trial

    Science.gov (United States)

    A microwave moisture measurement technique was developed for moisture sensing of cotton bales after the bale press. The technique measures the propagation delay of a microwave signal that is transmitted through the cotton bale. This research conducted a field trial to test the sensor in a commercial...

  19. 7 CFR 1755.3 - Field trials.

    Science.gov (United States)

    2010-01-01

    ...; (5) Responsibility for testing, test equipment and normal operation and maintenance during the trial... Telephone Systems of RUS Borrowers,” RUS Bulletin 344-2. When new items of materials or equipment are... modifications that its suitability cannot be determined based on laboratory data and/or field experience, a...

  20. [Placebo-controlled trials in schizophrenia].

    Science.gov (United States)

    Melamed, Yuval; Davidson, Michael; Bleich, Avi

    2004-03-01

    Clinical trials involving human subjects give rise to ethical and medico-legal dilemmas. Essential research of new drugs may potentially expose patients to ineffective medications or to placebo. The complexity of the problem increases when dealing with mentally ill patients, for whom, on the one hand there is no known cure for their disease, and on the other hand, it is sometimes questionable whether or not they are able to provide informed consent to participate in clinical trials. The Israel Psychiatric Association decided to develop a position paper on the subject of placebo-controlled clinical trials in schizophrenia patients. Discussion groups were established, and the available material in the professional literature was examined, with an emphasis on recent developments. The Declaration of Helsinki and its amendments were analyzed, and experts in the field were consulted. Clinical drug trials for development of new medications are essential in all fields of medicine, especially in psychiatry. The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. However, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when it may provide substantial benefit for some patients. Simultaneously, it is our duty to provide stringent restrictions that will enable strict supervision over the scientific, clinical and ethical aspects of the trials. We propose the following criteria for approval of pharmaceutical trials that include a placebo arm: scientific justification; clinical and ethical justification; provision of informed consent; recruitment of patients hospitalized voluntarily; prevention of harm; administration of additional potential therapeutic interventions; benefit to patients participating in the study; control and follow

  1. Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population-based screening (TOSYMA): protocol of a randomised controlled trial.

    Science.gov (United States)

    Weigel, Stefanie; Gerss, Joachim; Hense, Hans-Werner; Krischke, Miriam; Sommer, Alexander; Czwoydzinski, Jörg; Lenzen, Horst; Kerschke, Laura; Spieker, Karin; Dickmaenken, Stefanie; Baier, Sonja; Urban, Marc; Hecht, Gerold; Heidinger, Oliver; Kieschke, Joachim; Heindel, Walter

    2018-05-14

    Development of digital breast tomosynthesis (DBT) provides a technology that generates three-dimensional data sets, thus reducing the pitfalls of overlapping breast tissue. Observational studies suggest that the combination of two-dimensional (2D) digital mammography and DBT increases diagnostic accuracy. However, because of duplicate exposure, this comes at the cost of an augmented radiation dose. This undesired adverse impact can be avoided by using synthesised 2D images reconstructed from the DBT data (s2D).We designed a diagnostic superiority trial on a high level of evidence with the aim of providing a comparison of screening efficacy parameters resulting from DBT+s2D versus the current screening standard 2D full-field digital mammography (FFDM) in a multicentre and multivendor setting on the basis of the quality-controlled, population-based, biennial mammography screening programme in Germany. 80 000 women in the eligible age 50-69 years attending the routine mammography screening programme and willing to participate in the TOSYMA trial will be assigned by 1:1 randomisation to either the intervention arm (DBT+s2D) or the control arm (FFDM) during a 12-month recruitment period in screening units of North Rhine-Westphalia and Lower Saxony. State cancer registries will provide the follow-up of interval cancers.Primary endpoints are the detection rate of invasive breast cancers at screening examination and the cumulative incidence of interval cancers in the 2 years after a negative examination. Secondary endpoints are the detection rate of ductal carcinoma in situ and of tumour size T1, the recall rate for assessment, the positive predictive value of recall and the cumulative 12-month incidence of interval cancers. An adaptive statistical design with one interim analysis provides the option to modify the design. This protocol has been approved by the local medical ethical committee (2016-132-f-S). Results will be submitted to international peer

  2. High compliance randomized controlled field trial of solar disinfection of drinking water and its impact on childhood diarrhea in rural Cambodia

    CSIR Research Space (South Africa)

    McGuigan, KG

    2011-09-01

    Full Text Available of a 1 year randomized controlled trial investigating the effect of SODIS of drinking water on the incidence of dysentery and nondysentery diarrhea among children of age 6 months to 5 years living in rural communities in Cambodia. They compared 426...

  3. Field trial on a novel control method for the dengue vector, Aedes aegypti by the systematic use of Olyset® Net and pyriproxyfen in Southern Vietnam

    Directory of Open Access Journals (Sweden)

    Tsunoda Takashi

    2013-01-01

    Full Text Available Abstract Background Jars, tanks, and drums provide favorable rearing/breeding sites for Aedes aegypti in Vietnam. However, the use of insecticides to control mosquitoes at such breeding sites has not been approved in Vietnam since they are also often sources of drinking water, making larval vector control difficult. Mosquito nets pre-treated with long-lasting insecticide treated nets (LLITNs form an effective measure for malaria control. We examined changes in the abundance of immature Aedes aegypti to evaluate the efficacy of covering ceramic jars with lids comprising one type of LLITN, Olyset® Net, in inhibiting oviposition by adult females, and to evaluate the effect of treating other breeding containers, such as flower vases, inside and around the outside of houses with a slow-release pyriproxyfen formulation to kill pupae. Methods We selected 313 households for the trial and 363 households for the control in Tan Chanh, Long An province, Vietnam. In the trial area, Olyset® Net lids were used to cover five major types of water container (ceramic jars, cylindrical concrete tanks, other concrete tanks, plastic drums, and plastic buckets, while pyriproxyfen was used to treat flower vases and ant traps. We also monitored dengue virus transmission by measuring anti-dengue IgM and IgG levels in healthy residents in both control and trial areas to estimate the effectiveness of Olyset® Net at controlling the dengue vector, Aedes aegypti. Results The container-index and house-index for immature Ae. aegypti fell steeply one month after treatment in the trial area. Lids with Olyset® Net that fit container openings clearly seemed to reduce the presence of immature Ae. aegypti as the density of pupae decreased 1 month after treatment in the trial area. Pyriproxyfen was also effective at killing pupae in the water containers in the trial area. Although the dengue seroconversion rate was not influenced by Olyset® Net, it was lower in two-five year old

  4. Field trial on a novel control method for the dengue vector, Aedes aegypti by the systematic use of Olyset® Net and pyriproxyfen in Southern Vietnam.

    Science.gov (United States)

    Tsunoda, Takashi; Kawada, Hitoshi; Huynh, Trang T T; Luu, Loan Le; Le, San Hoang; Tran, Huu Ngoc; Vu, Huong Thi Que; Le, Hieu Minh; Hasebe, Futoshi; Tsuzuki, Ataru; Takagi, Masahiro

    2013-01-11

    Jars, tanks, and drums provide favorable rearing/breeding sites for Aedes aegypti in Vietnam. However, the use of insecticides to control mosquitoes at such breeding sites has not been approved in Vietnam since they are also often sources of drinking water, making larval vector control difficult. Mosquito nets pre-treated with long-lasting insecticide treated nets (LLITNs) form an effective measure for malaria control. We examined changes in the abundance of immature Aedes aegypti to evaluate the efficacy of covering ceramic jars with lids comprising one type of LLITN, Olyset® Net, in inhibiting oviposition by adult females, and to evaluate the effect of treating other breeding containers, such as flower vases, inside and around the outside of houses with a slow-release pyriproxyfen formulation to kill pupae. We selected 313 households for the trial and 363 households for the control in Tan Chanh, Long An province, Vietnam. In the trial area, Olyset® Net lids were used to cover five major types of water container (ceramic jars, cylindrical concrete tanks, other concrete tanks, plastic drums, and plastic buckets), while pyriproxyfen was used to treat flower vases and ant traps. We also monitored dengue virus transmission by measuring anti-dengue IgM and IgG levels in healthy residents in both control and trial areas to estimate the effectiveness of Olyset® Net at controlling the dengue vector, Aedes aegypti. The container-index and house-index for immature Ae. aegypti fell steeply one month after treatment in the trial area. Lids with Olyset® Net that fit container openings clearly seemed to reduce the presence of immature Ae. aegypti as the density of pupae decreased 1 month after treatment in the trial area. Pyriproxyfen was also effective at killing pupae in the water containers in the trial area. Although the dengue seroconversion rate was not influenced by Olyset® Net, it was lower in two-five year old children when compared to older children and adults in

  5. Malaria vaccines: lessons from field trials

    Directory of Open Access Journals (Sweden)

    Claudio J. Struchiner

    1994-07-01

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

  6. Effect of manual therapy versus proprioceptive neuromuscular facilitation in dynamic balance, mobility and flexibility in field hockey players. A randomized controlled trial.

    Science.gov (United States)

    Espí-López, Gemma V; López-Martínez, Susana; Inglés, Marta; Serra-Añó, Pilar; Aguilar-Rodríguez, Marta

    2018-04-22

    To compare the effectiveness of a specific Manual Therapy (MT) protocol applied to field hockey players (FHP), versus a Proprioceptive Neuromuscular Facilitation (PNF) protocol, in the improvement of dynamic balance, active range of movement and lumbar flexibility one-week and four-weeks after the treatment. Randomized controlled trial. Participants were assigned to 2 groups: MT and PNF. 30 min' sessions were performed once a week for three weeks. Three evaluations were performed: basal, one-week and four-weeks post-treatment. University of Valencia (Spain). 22 in MT group and 20 in PNF group. Dynamic Balance, measured with Star Excursion Balance Test; Active Range of Motion (ROM), using a manual goniometer and Lumbar Flexibility, assessed with Fingertip-to-floor test. Both groups significantly improved in lateral and medial dynamic balance one-week post-treatment (p < 0.05); but the improvement in the MT group lasted until the fourth-week after treatment in both reaches (lateral and medial) (p < 0.05). MT group also obtained significant improvements in dorsal flexion of the ankle in the fourth-week post-treatment (p < 0.05) and in lumbar flexibility one-week post-treatment (p < 0.05). MT and PNF improve dynamic balance one-week post-treatment; however, the improvement obtained through MT is maintained four-weeks later. Only MT improves dorsal flexion of the ankle four-weeks post-treatment and lumbar flexibility one-week post-treatment. Copyright © 2018 Elsevier Ltd. All rights reserved.

  7. Pulsed magnetic field versus ultrasound in the treatment of postnatal carpal tunnel syndrome: A randomized controlled trial in the women of an Egyptian population

    Directory of Open Access Journals (Sweden)

    Dalia M. Kamel

    2017-01-01

    Full Text Available The aim of this study was to compare the effects of pulsed electromagnetic field versus pulsed ultrasound in treating patients with postnatal carpal tunnel syndrome. The study was a randomized, double-blinded trial. Forty postnatal female patients with idiopathic carpal tunnel syndrome were divided randomly into two equal groups. One group received pulsed electromagnetic field, with nerve and tendon gliding exercises for the wrist, three times per week for four weeks. The other group received pulsed ultrasound and the same wrist exercises. Pain level, sensory and motor distal latencies and conduction velocities of the median nerve, functional status scale and hand grip strength were assessed pre- and post-treatment. There was a significant decrease (P  0.05. In conclusion, while the symptoms were alleviated in both groups, pulsed electromagnetic field was more effective than pulsed ultrasound in treating postnatal carpal tunnel syndrome.

  8. Biochar: from laboratory mechanisms through the greenhouse to field trials

    Science.gov (United States)

    Masiello, C. A.; Gao, X.; Dugan, B.; Silberg, J. J.; Zygourakis, K.; Alvarez, P. J. J.

    2014-12-01

    The biochar community is excellent at pointing to individual cases where biochar amendment has changed soil properties, with some studies showing significant improvements in crop yields, reduction in nutrient export, and remediation of pollutants. However, many studies exist which do not show improvements, and in some cases, studies clearly show detrimental outcomes. The next, crucial step in biochar science and engineering research will be to develop a process-based understanding of how biochar acts to improve soil properties. In particular, we need a better mechanistic understanding of how biochar sorbs and desorbs contaminants, how it interacts with soil water, and how it interacts with the soil microbial community. These mechanistic studies need to encompass processes that range from the nanometer to the kilometer scale. At the nanometer scale, we need a predictive model of how biochar will sorb and desorb hydrocarbons, nutrients, and toxic metals. At the micrometer scale we need models that explain biochar's effects on soil water, especially the plant-available fraction of soil water. The micrometer scale is also where mechanistic information is neeed about microbial processes. At the macroscale we need physical models to describe the landscape mobility of biochar, because biochar that washes away from fields can no longer provide crop benefits. To be most informative, biochar research should occur along a lab-greenhouse-field trial trajectory. Laboratory experiments should aim determine what mechanisms may act to control biochar-soil processes, and then greenhouse experiments can be used to test the significance of lab-derived mechanisms in short, highly replicated, controlled experiments. Once evidence of effect is determined from greenhouse experiments, field trials are merited. Field trials are the gold standard needed prior to full deployment, but results from field trials cannot be extrapolated to other field sites without the mechanistic backup provided

  9. Field trials results of guided wave tomography

    International Nuclear Information System (INIS)

    Volker, Arno; Zon, Tim van; Leden, Edwin van der

    2015-01-01

    Corrosion is one of the industries major issues regarding the integrity of assets. Guided wave travel time tomography is a method capable of providing an absolute wall thickness map. This method is currently making the transition from the laboratory to the field. For this purpose a dedicated data acquisition system and special purpose EMAT sensor rings have been developed. The system can be deployed for permanent monitoring and inspections. Field trials have been conducted on various pipes with different diameters, containing either liquid or gas. The main focus has been on pipe supports. The results demonstrate the successful operation of the technology in the field. Expected corrosion damage was clearly visible on the produced results enabling asset owner to make calculated decisions on the pipelines safety, maintenance and operations

  10. Field trials results of guided wave tomography

    Science.gov (United States)

    Volker, Arno; van Zon, Tim; van der Leden, Edwin

    2015-03-01

    Corrosion is one of the industries major issues regarding the integrity of assets. Guided wave travel time tomography is a method capable of providing an absolute wall thickness map. This method is currently making the transition from the laboratory to the field. For this purpose a dedicated data acquisition system and special purpose EMAT sensor rings have been developed. The system can be deployed for permanent monitoring and inspections. Field trials have been conducted on various pipes with different diameters, containing either liquid or gas. The main focus has been on pipe supports. The results demonstrate the successful operation of the technology in the field. Expected corrosion damage was clearly visible on the produced results enabling asset owner to make calculated decisions on the pipelines safety, maintenance and operations.

  11. Annual technical report. PV domestic field trial

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-07-01

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

  12. Lessons From Paired Data From exPVP Maize Lines in Agronomic Field Trials and RGB And Hyperspectral Time-Series Imaging In Controlled Environments

    Science.gov (United States)

    Schnable, J. C.; Pandey, P.; Ge, Y.; Xu, Y.; Qiu, Y.; Liang, Z.

    2017-12-01

    Maize Zea mays ssp. mays is one of three crops, along with rice and wheat, responsible for more than 1/2 of all calories consumed around the world. Increasing the yield and stress tolerance of these crops is essential to meet the growing need for food. The cost and speed of plant phenotyping is currently the largest constraint on plant breeding efforts. Datasets linking new types of high throughput phenotyping data collected from plants to the performance of the same genotypes under agronomic conditions across a wide range of environments are essential for developing new statistical approaches and computer vision based tools. A set of maize inbreds and hybrids - primarily recently off patent lines - were phenotyped using a high throughput platform at University of Nebraska-Lincoln. These lines have been previously subjected to high density genotyping, and scored for a core set of 13 phenotypes in field trials across 13 North American states in 2014, 2015, 2016, and 2017. Correlations between image-based measurements and manual measurements demonstrated the feasibility of quantifying variation in plant architecture using image data. However, we demonstrate that naive approaches to measuring traits such as biomass where are developed without integrating genotypic information can introduce nonrandom measurement errors which are confounded with variation between plant accessions. Analysis of hyperspectral image data demonstrated unique signatures from stem tissue which were not identified using aerial imagry. Integrating heritable phenotypes from high-throughput phenotyping data with field data from different environments can reveal previously unknown factors influencing yield plasticity.

  13. Impact of selected magnetic fields on the therapeutic effect in patients with lumbar discopathy: A prospective, randomized, single-blinded, and placebo-controlled clinical trial.

    Science.gov (United States)

    Taradaj, Jakub; Ozon, Marcin; Dymarek, Robert; Bolach, Bartosz; Walewicz, Karolina; Rosińczuk, Joanna

    2018-03-23

    Interdisciplinary physical therapy together with pharmacological treatment constitute conservative treatment strategies related to low back pain (LBP). There is still a lack of high quality studies aimed at an objective evaluation of physiotherapeutic procedures according to their effectiveness in LBP. The aim of this study is to carry out a prospective, randomized, single-blinded, and placebocontrolled clinical trial to evaluate the effectiveness of magnetic fields in discopathy-related LBP. A group of 177 patients was assessed for eligibility based on inclusion and exclusion criteria. In the end, 106 patients were randomly assigned into 5 comparative groups: A (n = 23; magnetic therapy: 10 mT, 50 Hz); B (n = 23; magnetic therapy: 5 mT, 50 Hz); C (n = 20; placebo magnetic therapy); D (n = 20; magnetic stimulation: 49.2 μT, 195 Hz); and E (n = 20; placebo magnetic stimulation). All patients were assessed using tests for pain intensity, degree of disability and range of motion. Also, postural stability was assessed using a stabilographic platform. In this study, positive changes in all clinical outcomes were demonstrated in group A (p 0.05). It was determined that the application of magnetic therapy (10 mT, 50 Hz, 20 min) significantly reduces pain symptoms and leads to an improvement of functional ability in patients with LBP.

  14. Recent randomized controlled trials in otolaryngology.

    Science.gov (United States)

    Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

    2015-03-01

    To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  15. A cluster randomized non-inferiority field trial on the immunogenicity and safety of tetanus toxoid vaccine kept in controlled temperature chain compared to cold chain.

    Science.gov (United States)

    Juan-Giner, Aitana; Domicent, Camille; Langendorf, Céline; Roper, Martha H; Baoundoh, Paul; Fermon, Florence; Gakima, Primitive; Zipursky, Simona; Tamadji, Mbaihol; Grais, Rebecca F

    2014-10-29

    In resource-poor settings, cold chain requirements present barriers for vaccine delivery. We evaluated the immunogenicity and safety of tetanus toxoid (TT) vaccine in "Controlled Temperature Chain" (CTC; up to 40 °C for cold chain (SCC; 2-8 °C). Prior to the study, stability parameters of TT-CTC were shown to meet international requirements. A cluster randomized, non-inferiority trial was conducted in Moïssala district, Chad, December 2012-March 2013. Thirty-four included clusters were randomized to CTC or SCC. Women aged 14-49 years, eligible for TT vaccination and with a history of ≤1 TT dose, received two TT doses 4 weeks apart. Participants were blinded to allocation strategy. Tetanus antibody titers were measured using standard ELISA at inclusion and 4 weeks post-TT2. Primary outcome measures were post-vaccination seroconversion and fold-increase in geometric mean concentrations (GMC). Non-inferiority was by seroconversion difference (TTSCC-TTCTC) 95% of participants; upper 95%CI of the difference was 5.6%. Increases in GMC were over 4-fold; upper 95%CI of GMC ratio was 1.36 in the adjusted analysis. Few adverse events were recorded. This study demonstrates the immunogenicity and safety of TT in CTC at cold chain cannot be maintained. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  16. Quality control of involved field radiotherapy in the HD 13 and HD 14 trials. Report of the radiotherapy panel of the German Hodgkin Study Group (GHSG)

    International Nuclear Information System (INIS)

    Kriz, J.; Haverkamp, U.; Eich, H.T.; Baues, C.; Engenhart-Cabillic, R.; Herfarth, K.; Lukas, P.; Pluetschow, A.; Fuchs, M.; Engert, A.; Schmidberger, H.; Staar, S.

    2017-01-01

    As part of the foundation of the German Hodgkin Study Group (GHSG) in 1978, a central radiotherapy (RT) reference centre was established to evaluate and to improve the quality of treatment. During the study generations, the quality assurance programs (QAP) were continued and adapted to the demands of each study. The purpose of this article is to demonstrate the results of the fifth study generation and to compare them to the previous findings. With the start of the fourth GHSG study generation (HD10-12), a central prospective review of all diagnostic images was established to create an individual treatment plan for each early stage study patient. The quality of involved field RT was retrospectively evaluated by an expert panel of radiation oncologists. In the fifth study generation (HD13-15), the retrospective review of radiotherapy performed was refined and the results were compared with the findings of the fourth generation. The expert panel analyzed the RT planning and application of 1037 (28 %) patients (HD13 n = 465, HD14 n = 572). Simulation films were available in 85 % of cases and verification films in 87 %. RT was assessed as major violation in 46 % (HD13 = 38 %, HD14 = 52 %), minor violation in 9 % (HD13 = 9 %, HD14 = 9 %) and according to the protocol in 45 % (HD13 = 52 %, HD14 = 38 %). The value for QAP of RT within the GHSG trials is well known. Still there were several protocol violations. In the future, the QAP program has to be adapted to the requirements of ''modern RT'' in malignant lymphoma. (orig.) [de

  17. Application of remote sensing to agricultural field trials

    NARCIS (Netherlands)

    Clevers, J.G.P.W.

    1986-01-01

    Remote sensing techniques enable quantitative information about a field trial to be obtained instantaneously and non-destructively. The aim of this study was to identify a method that can reduce inaccuracies in field trial analysis, and to identify how remote sensing can support and/or

  18. Trials on the Timing of Chemical Control of Lentil weevil, Bruchus lentis Frӧlich (Coleoptera: Chrysomelidae: Bruchinae in Lentil Field in Gachsaran Region (Iran

    Directory of Open Access Journals (Sweden)

    K. Saeidi

    2017-12-01

    Full Text Available The lentil weevil, Bruchus lentis Frӧlich, (Coleoptera: Chrysomelidae: Bruchinae is the most serious pest of lentil in Iran. Economic losses due to this pest reach up to 40% of the lentil crop. Over a two-year study (2012 and 2013 in Agricultural Research Station of Gachsaran Region, best timing of chemical control of B. lentis was determined. A field experiment with cultivation of lentil Sina variety Lens culinaris Medik was conducted in a randomized complete block design with five treatments and three replications. The treatments consisted of spraying four times (respectively, during the early flowering, 10 days after the first spraying, 10 days after the second spraying; 10 days after the third spraying and control (without spraying. For the spraying from Endosulfan insecticide EC50% at ratio one liter per hectare was used. Three samples were taken from the pods and totally 150 pods from each replicate for contaminations of seeds were investigated. After the determination of the percent of seeds contamination, results were statistically analysed. Based on the results obtained, first spray treatment, with the mean contamination of 15.45% and second spray treatment with the mean contamination of 12.25% had the highest impact on reducing contamination lentil seeds to B. lentis and between them there was no statistically significant difference and were in one group. Therefore, spraying one time during the early flowering until 15 days after it was the best time to control of B. lentis.

  19. SU-F-P-52: A Meta-Analysis of Controlled Clinical Trials Comparing Elective Nodal Irradiation with Involved-Field Irradiation for Conformal Or Intensity-Modulated Radiotherapy in Patients with Esophageal Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Bai, W; Zhang, R; Zhou, Z; Qiao, X [The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei (China)

    2016-06-15

    Purpose: To compare elective nodal irradiation with involved-field irradiation for three-dimensional conformal radiotherapy or intensity-modulated radiotherapy in patients with esophageal cancer by a metaanalysis. Methods: Wanfang, CNKI, VIP, CBM databases, PubMed, Embase and Cochrane Library were searched to identify the controlled clinical trials of elective nodal irradiation with involved-field irradiation for three-dimensional conformal radiotherapy or intensity-modulated radiotherapy in patients with esophageal cancer. The obtained data were analyzed using Stata 11.0. The difference between two groups was estimated by calculating the odds ratio (OR) with 95% confidence interval (95% CI). Results: A total of 12 controlled clinical trials involving 1095 esophageal cancer patients, which were selected according to inclusion and exclusion criteria, were included in this meta-analysis. The meta-analysis showed that the elective nodal irradiation group reduced the rates of out-field failure comparing with involved-field irradiation group (OR=3.727, P=0.007). However, the rates of ≥grades 3 acute radiation pneumonitis and esophagitis were significantly higher in the elective nodal irradiation group than in the involved-field irradiation group (OR=0.348, P=0.001, OR=0.385, P=0.000). 1-, 2-, 3-year local control rates (OR=0.966, P=0.837, OR=0.946, P=0.781; OR=0.732P=0.098) and 1-, 3-, 5-year survival rates were similar in the two groups ( OR=0.966, P=0.837; OR=0.946, P=0.781; OR=0.732, P=0.098; OR=0.952, P=0.756; OR=1.149, P=0.422; OR=0.768, P=0.120). It is the same with the rates of distant metastasis (OR=0.986, P=0.937). Conclusion: Compared with involved-field irradiation, the elective nodal irradiation can reduce the rates of out-field failure for three-dimensional conformal radiotherapy or intensity-modulated radiotherapy in patients with esophageal cancer. However, its advantage of local control and survival rates is not obvious and it increases the incidence

  20. [Principles of controlled clinical trials].

    Science.gov (United States)

    Martini, P

    1962-01-01

    The recovery of the patient should be facilitated as the result of therapeutic research. The basic rule for every therapeutic-clinical trial mist involve a comparison of therapeutic approaches. In acute conditions, such as acute infectious diseases, infarcts, etc., comparisons should be made between two or more groups: the collective therapeutic comparison = the between patients trial. The formation of groups, to be compared one with the other can be justified only if one is reasonably sure that a pathogenic condition indeed exists. In chronic diseases, which extend essentially unchanged over a lengthy period but are nevertheless reversible, therapeutic comparisons may be made between two or more time intervals within the course of the disease in the same individual. This type of therapeutic trial rests primarily upon a (refined!) type of specious reasoning and secondarily, upon modified statistics: the individual therapeutic comparison = the within patient trial. The collective therapeutic comparison, on the one hand, and the individual therapeutic comparison on the other, overlap somewhat in scope. The immediate therapeutic effect is not always an indication of its true value, which may become evident only upon long-term treatment. The short-term trials of therapeutic regimens in an individual must, therefore, be frequently supplemented by long-term trials which can only be carried out by comparing two groups. For many clinical investigations, therefore, the joint efforts of numerous hospitals are absolutely necessary. The second basic rule of therapeutic research is the elimination of secondary causes. The difficulties introduced by these secondary considerations are far greater in therapeutic trials carried out on ambulatory patients than has been hitherto realized. In order to remove subjective secondary causes, the author demanded, in 1931, the use of hidden or illusory media (placebos, dummies) that is, unconscious causative agents. The double blind

  1. The role of mHealth intervention on maternal and child health service delivery: findings from a randomized controlled field trial in rural Ethiopia.

    Science.gov (United States)

    Atnafu, Asfaw; Otto, Kate; Herbst, Christopher H

    2017-01-01

    The provision of consistent and quality maternal and child health (MCH) services is a challenge for Ethiopia where most of the population lives in the rural setup. Health service delivery is constrained mainly by shortage of health professionals, meager resources, limited awareness among the society and bureaucratic procedures. Low health service utilization of antenatal care (ANC), delivery services, and postnatal care (PNC) are believed to contribute for high maternal and child mortality rates. Innovative approach like mHealth based technological intervention believed to alleviate such challenges in countries like ours. However, currently, there are few evidences that demonstrate the impact of mHealth technology applications on the level of service utilization. Therefore, the objective our study is to assess the role of mobile phone equipped with short message service (SMS) based data-exchange software linking community health workers to Health Centers in rural Ethiopia affect selected MCH outcomes. A community-based randomized control trial (RCT) was conducted in three woredas of Guraghe zone (Ezha, partial &Abeshge full intervention, Sodo Control). Mobile phones equipped with FrontlineSMS based, locally developed application was distributed to all health extension workers (HEWs) to both intervention woredas who filled maternal, child and stock related forms and submitted to the central server which in turn sends reminder about the scheduled date of ANC visit, expected date of delivery, PNC, immunization schedule and vaccine and contraceptive stock status. Moreover, in Abeshge, the voluntary health workers (vCHW) and HEW supervisors in both intervention woreda were given a phone to facilitate communication with the HEW. No mobile was offered to the control woreda.Pre [2012] and post [2013] intervention community based survey on mothers who have under 5 and under 1 year old child was done to assess the effect of the mobile intervention on selected MCH process

  2. Conducting field trials for frost tolerance breeding in cereals.

    Science.gov (United States)

    Cattivelli, Luigi

    2014-01-01

    Cereal species can be damaged by frost either during winter or at flowering stage. Frost tolerance per se is only a part of the mechanisms that allow the plants to survive during winter; winterhardiness also considers other biotic or physical stresses that challenge the plants during the winter season limiting their survival rate. While frost tolerance can also be tested in controlled environments, winterhardiness can be determined only with field evaluations. Post-heading frost damage occurs from radiation frost events in spring during the reproductive stages. A reliable evaluation of winterhardiness or of post-heading frost damage should be carried out with field trials replicated across years and locations to overcome the irregular occurrence of natural conditions which satisfactorily differentiate genotypes. The evaluation of post-heading frost damage requires a specific attention to plant phenology. The extent of frost damage is usually determined with a visual score at the end of the winter.

  3. Quality control of involved field radiotherapy in the HD 13 and HD 14 trials. Report of the radiotherapy panel of the German Hodgkin Study Group (GHSG)

    Energy Technology Data Exchange (ETDEWEB)

    Kriz, J.; Haverkamp, U.; Eich, H.T. [University of Muenster, Department of Radiation Oncology, Muenster (Germany); Baues, C. [University of Cologne, Department of Radiation Oncology, Cologne (Germany); Engenhart-Cabillic, R. [University of Marburg, Department of Radiation Oncology, Marburg (Germany); Herfarth, K. [University of Heidelberg, Department of Radiation Oncology, Heidelberg (Germany); Lukas, P. [University of Innsbruck, Department of Radiation Oncology, Innsbruck (Austria); Pluetschow, A.; Fuchs, M.; Engert, A. [University of Cologne, Department of Internal Medicine, Cologne (Germany); Schmidberger, H. [University of Mainz, Department of Radiation Oncology, Mainz (Germany); Staar, S. [Bremen Mitte, Department of Radiation Oncology, Bremen (Germany)

    2017-02-15

    As part of the foundation of the German Hodgkin Study Group (GHSG) in 1978, a central radiotherapy (RT) reference centre was established to evaluate and to improve the quality of treatment. During the study generations, the quality assurance programs (QAP) were continued and adapted to the demands of each study. The purpose of this article is to demonstrate the results of the fifth study generation and to compare them to the previous findings. With the start of the fourth GHSG study generation (HD10-12), a central prospective review of all diagnostic images was established to create an individual treatment plan for each early stage study patient. The quality of involved field RT was retrospectively evaluated by an expert panel of radiation oncologists. In the fifth study generation (HD13-15), the retrospective review of radiotherapy performed was refined and the results were compared with the findings of the fourth generation. The expert panel analyzed the RT planning and application of 1037 (28 %) patients (HD13 n = 465, HD14 n = 572). Simulation films were available in 85 % of cases and verification films in 87 %. RT was assessed as major violation in 46 % (HD13 = 38 %, HD14 = 52 %), minor violation in 9 % (HD13 = 9 %, HD14 = 9 %) and according to the protocol in 45 % (HD13 = 52 %, HD14 = 38 %). The value for QAP of RT within the GHSG trials is well known. Still there were several protocol violations. In the future, the QAP program has to be adapted to the requirements of ''modern RT'' in malignant lymphoma. (orig.) [German] Seit Gruendung der German Hodgkin Study Group (GHSG) im Jahr 1978 wurde ein zentrales Qualitaetssicherungsprogramm (QAP) der Radiotherapie (RT) etabliert, um die Qualitaet der RT sicherzustellen. Waehrend der fortlaufenden Studiengenerationen wurde dieses QAP kontinuierlich weiterentwickelt. In dieser Auswertung werden die Ergebnisse der fuenften Studiengeneration (HD13-15) praesentiert und mit frueheren Ergebnissen

  4. Effects of Hypotensive Anesthesia on Reducing Intraoperative Blood Loss, Duration of Operation, and Quality of Surgical Field During Orthognathic Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Lin, Susie; McKenna, Samuel J; Yao, Chuan-Fong; Chen, Yu-Ray; Chen, Chit

    2017-01-01

    The objective of this study was to evaluate the efficacy of hypotensive anesthesia in reducing intraoperative blood loss, decreasing operation time, and improving the quality of the surgical field during orthognathic surgery. A systematic review and meta-analysis of randomized controlled trials addressing these issues were carried out. An electronic database search was performed. The risk of bias was evaluated with the Jadad Scale and Delphi List. The inverse variance statistical method and a random-effects model were used. Ten randomized controlled trials were included for analysis. Our meta-analysis indicated that hypotensive anesthesia reduced intraoperative blood loss by a mean of about 169 mL. Hypotensive anesthesia was not shown to reduce the operation time for orthognathic surgery, but it did improve the quality of the surgical field. Subgroup analysis indicated that for blood loss in double-jaw surgery, the weighted mean difference favored the hypotensive group, with a reduction in blood loss of 175 mL, but no statistically significant reduction in blood loss was found for anterior maxillary osteotomy. If local anesthesia with epinephrine was used in conjunction with hypotensive anesthesia, the reduction in intraoperative blood loss was increased to 254.93 mL. Hypotensive anesthesia was effective in reducing blood loss and improving the quality of the surgical field, but it did not reduce the operation time for orthognathic surgery. The use of local anesthesia in conjunction with hypotensive general anesthesia further reduced the amount of intraoperative blood loss for orthognathic surgery. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  5. Spread and control of blackgrass (Alopecurus myosuroides according to an increasing occurrence of resistance - Evaluation of field trials in the federal states Brandenburg, Hessen, Saxony, Saxony-Anhalt and Thuringia in the years 2000 - 2014

    Directory of Open Access Journals (Sweden)

    Meinlschmidt, Ewa

    2016-02-01

    Full Text Available An increasing occurrence of blackgrass (Alopecurus myosuroides with high densities has been reported for Brandenburg, Hessen, Saxony-Anhalt, Saxony and Thuringia. In recent years, an increasing resistance to blackgrass especially to ALS inhibitors and partially to ACCase inhibitors has been reported for some eastern federal states and Hessen, too. It was determined to what extent dicotyledonous weeds are associated with blackgrass. The efficacy of different herbicide applications was tested in field trials between 2000 and 2014. A total of 191 trials have been included in the analysis of blackgrass. Using the HRAC-classification of herbicides tested, combinations of herbicides were used which might contribute to solve problems specifically linked to the detected resistance situation of the site. The study aimed to identify the right timing of the herbicide applications as well as applications as single or serial treatments and the use of herbicide at reduced doses according to the intensity of blackgrass. In autumn, single applications of soil active herbicides were not effective enough, especially at a high density of more than 500 heads of blackgrass per m2. The mixtures of soil active herbicides with leave active herbicides applied in autumn achieved very good control. The herbicide sequences were more effective than single applications. In order to counteract further spread of herbicide resistance, the right choice of the mode of action and highly efficacious herbicide treatments are the methods of choice, of course in addition to nonchemical controlling measures such as delayed autumn drilling, ploughing and crop rotation.

  6. Design of a randomized controlled trial on the effect on return to work with coaching plus light therapy and pulsed electromagnetic field therapy for workers with work-related chronic stress

    Directory of Open Access Journals (Sweden)

    Antonius M. C. Schoutens

    2016-07-01

    Full Text Available Abstract Background Work-related chronic stress is a common problem among workers. The core complaint is that the employee feels exhausted, which has an effect on the well-being and functioning of the employee, and an impact on the employer and society. The employee’s absence is costly due to lost productivity and medical expenses. The usual form of care for work-related chronic stress is coaching, using a cognitive-behavioural approach whose primary aim is to reduce symptoms and improve functioning. Light therapy and pulsed electromagnetic field therapy are used for the treatment of several mental and physical disorders. The objective of this study is to determine whether coaching combined with light therapy plus pulsed electromagnetic field therapy is an effective treatment for reducing absenteeism, fatigue and stress, and improving quality of life compared to coaching alone. Methods/design The randomized placebo-controlled trial consists of three arms. The population consists of 90 participants with work-related chronic stress complaints. The research groups are: (i intervention group; (ii placebo group; and (iii control group. Participants in the intervention group will be treated with light therapy/pulsed electromagnetic field therapy for 12 weeks, twice a week for 40 min, and coaching (once a fortnight for 50 min. The placebo group receives the same treatment but with the light and pulsed electromagnetic field switched to placebo settings. The control group receives only coaching for 12 weeks, a course of six sessions, once a fortnight for 50 min. The primary outcome is the level of return to work. Secondary outcomes are fatigue, stress and quality of life. Outcomes will be measured at baseline, 6 weeks, 12 and 24 weeks after start of treatment. Discussion This study will provide information about the effectiveness of coaching and light therapy plus pulsed electromagnetic field therapy on return to work, and secondly on fatigue

  7. A field test of a web-based workplace health promotion program to improve dietary practices, reduce stress, and increase physical activity: randomized controlled trial.

    Science.gov (United States)

    Cook, Royer F; Billings, Douglas W; Hersch, Rebekah K; Back, Anita S; Hendrickson, April

    2007-06-19

    Most work sites engage in some form of health promotion programming designed to improve worker health and reduce health care costs. Although these programs have typically been delivered through combinations of seminars and print materials, workplace health promotion programs are increasingly being delivered through the Internet. The purpose of this research was to evaluate the effectiveness of a Web-based multimedia health promotion program for the workplace, designed to improve dietary practices, reduce stress, and increase physical activity. Using a randomized controlled trial design with pretest-posttest comparisons within each group, 419 employees of a human resources company were randomly assigned to the Web-based condition or to a condition that provided print materials on the same topics. All subjects were assessed at pretest and posttest through an online questionnaire containing multiple measures of health behavior and attitudes. The test period was 3 months. Questionnaire data were analyzed mainly by analysis of covariance and t tests. Retention rates were good for both groups-85% for the Web-based group and 87% for the print group. Subjects using the Web-based program performed significantly better than the print group on Attitudes Toward a Healthful Diet (F(1,415) = 7.104, P = .008) and Dietary Stage of Change (F(1,408) = 6.487, P = .01), but there were no significant group differences on the five other dietary measures. Both groups also showed improvement from pretest to posttest on most dietary measures, as indicated by significant t tests. Within the Web-based group, dosage analyses showed significant effects of the number of times the subject accessed the program on measures of Dietary Self-Efficacy (F(2,203) = 5.270, P = .003), Attitudes Toward a Healthful Diet (F(2,204) = 2.585, P = .045), and Dietary Stage of Change (F(2,200) = 4.627, P = .005). No significant differences were found between the two groups on measures of stress or physical

  8. The influence of catch trials on the consolidation of motor memory in force field adaptation tasks

    Directory of Open Access Journals (Sweden)

    Anne eFocke

    2013-07-01

    Full Text Available In computational neuroscience it is generally accepted that human motor memory contains neural representations of the physics of the musculoskeletal system and the objects in the environment. These representations are called internal models. Force field studies, in which subjects have to adapt to dynamic perturbations induced by a robotic manipulandum, are an established tool to analyze the characteristics of such internal models. The aim of the current study was to investigate whether catch trials during force field learning could influence the consolidation of motor memory in more complex tasks. Thereby, the force field was more than double the force field of previous studies (35 Ns/m. Moreover, the arm of the subjects was not supported. A total of forty-six subjects participated in this study and performed center-out movements at a robotic manipulandum in two different force fields. Two control groups learned force field A on day 1 and were retested in the same force field on day 3 (AA. Two test groups additionally learned an interfering force field B (=-A on day 2 (ABA. The difference between the two test and control groups, respectively, was the absence (0% or presence (19% of catch trials, in which the force field was turned off suddenly. The results showed consolidation of force field A on day 3 for both control groups. Test groups showed no consolidation of force field A (19% catch trials and even poorer performance on day 3 (0% catch trials. In conclusion, it can be stated that catch trials seem to have a positive effect on the performance on day 3 but do not trigger a consolidation process as shown in previous studies that used a lower force field viscosity with supported arm. These findings indicate that the results of previous studies in which less complex tasks were analyzed, cannot be fully transferred to more complex tasks. Moreover, the effects of catch trials in these situations are insufficiently understood and further research

  9. Evaluation of a randomized controlled trial on the effect on return to work with coaching combined with light therapy and pulsed electromagnetic field therapy for workers with work-related chronic stress

    Directory of Open Access Journals (Sweden)

    Karen Nieuwenhuijsen

    2017-10-01

    Full Text Available Abstract Background Chronic work-related stress is quite prevalent in the working population and is in some cases accompanied by long-term sick leave. These stress complaints highly impact employees and are costly due to lost productivity and medical expenses. A new treatment platform with light therapy plus Pulsed Electro Magnetic Fields (PEMF in combination with coaching was used to assess whether more positive effects on return to work, stress, work-related fatigue, and quality of life could be induced compared to coaching alone. Methods A placebo-controlled trial was executed after inclusion of 96 workers, aged 18–65 with work-related chronic stress complaints and who were on sick leave (either part-time or full-time. Participants were divided into three arms at random. Group 1 (n = 28 received the treatment and coaching (Intervention group, group 2 (n = 28 received the treatment with the device turned off and coaching (Placebo group and group 3 (n = 28 received coaching only (Control group. The data were collected at baseline, and after 6, 12 and 24 weeks. The primary outcome was % return to work, and secondary outcomes were work-related fatigue (emotional exhaustion and need for recovery after work, stress (distress and hair cortisol, and quality of life (SF-36 dimensions: vitality, emotional role limitation, and social functioning. Results Eighty-four workers completed all measurements, 28 in each group. All groups improved significantly over time in the level of return to work, as well as on all secondary outcomes. No statistical differences between the three groups were found either on the primary outcome or on any of the secondary outcomes. Conclusions Light therapy with Pulsed Electro Magnetic Fields PEMF therapy has no additional effect on return to work, stress, fatigue, and quality of live compared to coaching alone. Trial registration NTR4794 , registration date: 18-sep-2014

  10. Randomised controlled trials in Scandinavian educational research

    DEFF Research Database (Denmark)

    Pontoppidan, Maiken; Keilow, Maria; Dietrichson, Jens

    2018-01-01

    of this paper is to examine the history of randomised controlled trials in Scandinavian compulsory schools (grades 0–10; pupil ages 6-15). Specifically, we investigate drivers and barriers for randomised controlled trials in educational research and the differences between the three Scandinavian countries...... crucial for the implementation of RCTs and are likely more important in smaller countries such as the Scandinavian ones. Supporting institutions have now been established in all three countries, and we believe that the use of RCTs in Scandinavian educational research is likely to continue....... or more interventions were randomly assigned to groups of students and carried out in a school setting with the primary aim of improving the academic performance of children aged 6-15 in grades 0–10 in Denmark, Norway, or Sweden. We included both conducted and ongoing trials. Publications that seemed...

  11. Assessing the risk of bias in randomized controlled trials in the field of dentistry indexed in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database.

    Science.gov (United States)

    Ferreira, Christiane Alves; Loureiro, Carlos Alfredo Salles; Saconato, Humberto; Atallah, Alvaro Nagib

    2011-03-01

    Well-conducted randomized controlled trials (RCTs) represent the highest level of evidence when the research question relates to the effect of therapeutic or preventive interventions. However, the degree of control over bias between RCTs presents great variability between studies. For this reason, with the increasing interest in and production of systematic reviews and meta-analyses, it has been necessary to develop methodology supported by empirical evidence, so as to encourage and enhance the production of valid RCTs with low risk of bias. The aim here was to conduct a methodological analysis within the field of dentistry, regarding the risk of bias in open-access RCTs available in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database. This was a methodology study conducted at Universidade Federal de São Paulo (Unifesp) that assessed the risk of bias in RCTs, using the following dimensions: allocation sequence generation, allocation concealment, blinding, and data on incomplete outcomes. Out of the 4,503 articles classified, only 10 studies (0.22%) were considered to be true RCTs and, of these, only a single study was classified as presenting low risk of bias. The items that the authors of these RCTs most frequently controlled for were blinding and data on incomplete outcomes. The effective presence of bias seriously weakened the reliability of the results from the dental studies evaluated, such that they would be of little use for clinicians and administrators as support for decision-making processes.

  12. Soil stabilization field trial : final report.

    Science.gov (United States)

    2006-01-01

    A five-year study was initiated seeking materials/additives and procedures that help to mitigate : crack susceptibility in cement-treated material (CTM). A field test program of six 305-m (1000-ft) test : sections was implemented in August 2000. The ...

  13. Design of a randomized controlled trial on the effect on return to work with coaching plus light therapy and pulsed electromagnetic field therapy for workers with work-related chronic stress.

    Science.gov (United States)

    Schoutens, Antonius M C; Frings-Dresen, Monique H W; Sluiter, Judith K

    2016-07-19

    Work-related chronic stress is a common problem among workers. The core complaint is that the employee feels exhausted, which has an effect on the well-being and functioning of the employee, and an impact on the employer and society. The employee's absence is costly due to lost productivity and medical expenses. The usual form of care for work-related chronic stress is coaching, using a cognitive-behavioural approach whose primary aim is to reduce symptoms and improve functioning. Light therapy and pulsed electromagnetic field therapy are used for the treatment of several mental and physical disorders. The objective of this study is to determine whether coaching combined with light therapy plus pulsed electromagnetic field therapy is an effective treatment for reducing absenteeism, fatigue and stress, and improving quality of life compared to coaching alone. The randomized placebo-controlled trial consists of three arms. The population consists of 90 participants with work-related chronic stress complaints. The research groups are: (i) intervention group; (ii) placebo group; and (iii) control group. Participants in the intervention group will be treated with light therapy/pulsed electromagnetic field therapy for 12 weeks, twice a week for 40 min, and coaching (once a fortnight for 50 min). The placebo group receives the same treatment but with the light and pulsed electromagnetic field switched to placebo settings. The control group receives only coaching for 12 weeks, a course of six sessions, once a fortnight for 50 min. The primary outcome is the level of return to work. Secondary outcomes are fatigue, stress and quality of life. Outcomes will be measured at baseline, 6 weeks, 12 and 24 weeks after start of treatment. This study will provide information about the effectiveness of coaching and light therapy plus pulsed electromagnetic field therapy on return to work, and secondly on fatigue, stress and quality of life in people with work-related chronic

  14. a randomised controlled trial oftwo prostaglandin regitnens

    African Journals Online (AJOL)

    Design. A prospective randomised controlled trial. Setting. Department of Obstetrics and Gynae- ... hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 .... Tygerberg Hospital for permission to publish, and Upjohn. (Pry) Ltd for supplying the Prepidil gel used in the study. 1.

  15. Is the randomised controlled trial the best?

    African Journals Online (AJOL)

    The randomised controlled trial (RCT) is recog nised as the gold standard of research methods, particularly to test efficacy. The primary benefit of the RCT, as everyone knows, is to prevent patient selection bias. And it should also guarantee some rigour of research methodology. It is always prospective. In a nonrandomised ...

  16. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

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

  17. Empirical trials of plant field guides.

    Science.gov (United States)

    Hawthorne, W D; Cable, S; Marshall, C A M

    2014-06-01

    We designed 3 image-based field guides to tropical forest plant species in Ghana, Grenada, and Cameroon and tested them with 1095 local residents and 20 botanists in the United Kingdom. We compared users' identification accuracy with different image formats, including drawings, specimen photos, living plant photos, and paintings. We compared users' accuracy with the guides to their accuracy with only their prior knowledge of the flora. We asked respondents to score each format for usability, beauty, and how much they would pay for it. Prior knowledge of plant names was generally low (<22%). With a few exceptions, identification accuracy did not differ significantly among image formats. In Cameroon, users identifying sterile Cola species achieved 46-56% accuracy across formats; identification was most accurate with living plant photos. Botanists in the United Kingdom accurately identified 82-93% of the same Cameroonian species; identification was most accurate with specimens. In Grenada, users accurately identified 74-82% of plants; drawings yielded significantly less accurate identifications than paintings and photos of living plants. In Ghana, users accurately identified 85% of plants. Digital color photos of living plants ranked high for beauty, usability, and what users would pay. Black and white drawings ranked low. Our results show the potential and limitations of the use of field guides and nonspecialists to identify plants, for example, in conservation applications. We recommend authors of plant field guides use the cheapest or easiest illustration format because image type had limited bearing on accuracy; match the type of illustration to the most likely use of the guide for slight improvements in accuracy; avoid black and white formats unless the audience is experienced at interpreting illustrations or keeping costs low is imperative; discourage false-positive identifications, which were common; and encourage users to ask an expert or use a herbarium for

  18. Differences in field effectiveness and adoption between a novel automated chlorination system and household manual chlorination of drinking water in Dhaka, Bangladesh: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Amy J Pickering

    Full Text Available The number of people served by networked systems that supply intermittent and contaminated drinking water is increasing. In these settings, centralized water treatment is ineffective, while household-level water treatment technologies have not been brought to scale. This study compares a novel low-cost technology designed to passively (automatically dispense chlorine at shared handpumps with a household-level intervention providing water disinfection tablets (Aquatab, safe water storage containers, and behavior promotion. Twenty compounds were enrolled in Dhaka, Bangladesh, and randomly assigned to one of three groups: passive chlorinator, Aquatabs, or control. Over a 10-month intervention period, the mean percentage of households whose stored drinking water had detectable total chlorine was 75% in compounds with access to the passive chlorinator, 72% in compounds receiving Aquatabs, and 6% in control compounds. Both interventions also significantly improved microbial water quality. Aquatabs usage fell by 50% after behavioral promotion visits concluded, suggesting intensive promotion is necessary for sustained uptake. The study findings suggest high potential for an automated decentralized water treatment system to increase consistent access to clean water in low-income urban communities.

  19. Differences in Field Effectiveness and Adoption between a Novel Automated Chlorination System and Household Manual Chlorination of Drinking Water in Dhaka, Bangladesh: A Randomized Controlled Trial

    Science.gov (United States)

    Pickering, Amy J.; Crider, Yoshika; Amin, Nuhu; Bauza, Valerie; Unicomb, Leanne; Davis, Jennifer; Luby, Stephen P.

    2015-01-01

    The number of people served by networked systems that supply intermittent and contaminated drinking water is increasing. In these settings, centralized water treatment is ineffective, while household-level water treatment technologies have not been brought to scale. This study compares a novel low-cost technology designed to passively (automatically) dispense chlorine at shared handpumps with a household-level intervention providing water disinfection tablets (Aquatab), safe water storage containers, and behavior promotion. Twenty compounds were enrolled in Dhaka, Bangladesh, and randomly assigned to one of three groups: passive chlorinator, Aquatabs, or control. Over a 10-month intervention period, the mean percentage of households whose stored drinking water had detectable total chlorine was 75% in compounds with access to the passive chlorinator, 72% in compounds receiving Aquatabs, and 6% in control compounds. Both interventions also significantly improved microbial water quality. Aquatabs usage fell by 50% after behavioral promotion visits concluded, suggesting intensive promotion is necessary for sustained uptake. The study findings suggest high potential for an automated decentralized water treatment system to increase consistent access to clean water in low-income urban communities. PMID:25734448

  20. Differences in field effectiveness and adoption between a novel automated chlorination system and household manual chlorination of drinking water in Dhaka, Bangladesh: a randomized controlled trial.

    Science.gov (United States)

    Pickering, Amy J; Crider, Yoshika; Amin, Nuhu; Bauza, Valerie; Unicomb, Leanne; Davis, Jennifer; Luby, Stephen P

    2015-01-01

    The number of people served by networked systems that supply intermittent and contaminated drinking water is increasing. In these settings, centralized water treatment is ineffective, while household-level water treatment technologies have not been brought to scale. This study compares a novel low-cost technology designed to passively (automatically) dispense chlorine at shared handpumps with a household-level intervention providing water disinfection tablets (Aquatab), safe water storage containers, and behavior promotion. Twenty compounds were enrolled in Dhaka, Bangladesh, and randomly assigned to one of three groups: passive chlorinator, Aquatabs, or control. Over a 10-month intervention period, the mean percentage of households whose stored drinking water had detectable total chlorine was 75% in compounds with access to the passive chlorinator, 72% in compounds receiving Aquatabs, and 6% in control compounds. Both interventions also significantly improved microbial water quality. Aquatabs usage fell by 50% after behavioral promotion visits concluded, suggesting intensive promotion is necessary for sustained uptake. The study findings suggest high potential for an automated decentralized water treatment system to increase consistent access to clean water in low-income urban communities.

  1. Control groups in recent septic shock trials

    DEFF Research Database (Denmark)

    Pettilä, Ville; Hjortrup, Peter B; Jakob, Stephan M

    2016-01-01

    PURPOSE: The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials. METHODS: We searched for original articles presenting......, and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting. RESULTS: A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58...... % the proportion of patients with elevated lactate values. Five studies (21 %) provided data to estimate the proportion of septic shock patients fulfilling the Sepsis-3 definition. The mean data completeness score was 19 out of 36 (range 8-32). Of 18 predefined control group characteristics, a mean of 8 (range 2...

  2. A randomized, double-blind, placebo-controlled field trial to determine the efficacy and safety of Malarone (atovaquone/proguanil) for the prophylaxis of malaria in Zambia.

    Science.gov (United States)

    Sukwa, T Y; Mulenga, M; Chisdaka, N; Roskell, N S; Scott, T R

    1999-04-01

    Malaria poses a major health risk to people who are exposed to infection in malaria-endemic areas. A randomized, double-blind, placebo-controlled study was conducted to determine the efficacy and safety of Malarone (250 mg of atovaquone/100 mg of proguanil hydrochloride per tablet) for the chemoprophylaxis of Plasmodium falciparum malaria in Zambia. Adult volunteers received a three-day treatment course of Malarone to eliminate pre-existing parasitemia and were then immediately randomized to treatment with either one Malarone tablet daily (n = 136), or one placebo tablet daily (n = 138) for at least 10 weeks. Malaria blood smears were prepared on a weekly basis and a failure of chemoprophylaxis was defined as any subject who had a positive blood smear, or who withdrew from the study due to a treatment-related adverse event. The prophylaxis success rates in the Malarone and placebo groups were 98% and 63%, respectively (P < 0.001). The most commonly reported adverse events with at least a possible causal relationship to study medication were headache and abdominal pain, which occurred with a higher incidence in the placebo group. No subjects were withdrawn from the study due to a treatment-related adverse event. Thus, Malarone appears to have an excellent safety and efficacy profile for the chemoprophylaxis of P. falciparum infection.

  3. Evaluation of a randomized controlled trial on the effect on return to work with coaching combined with light therapy and pulsed electromagnetic field therapy for workers with work-related chronic stress.

    Science.gov (United States)

    Nieuwenhuijsen, Karen; Schoutens, Antonius M C; Frings-Dresen, Monique H W; Sluiter, Judith K

    2017-10-02

    Chronic work-related stress is quite prevalent in the working population and is in some cases accompanied by long-term sick leave. These stress complaints highly impact employees and are costly due to lost productivity and medical expenses. A new treatment platform with light therapy plus Pulsed Electro Magnetic Fields (PEMF) in combination with coaching was used to assess whether more positive effects on return to work, stress, work-related fatigue, and quality of life could be induced compared to coaching alone. A placebo-controlled trial was executed after inclusion of 96 workers, aged 18-65 with work-related chronic stress complaints and who were on sick leave (either part-time or full-time). Participants were divided into three arms at random. Group 1 (n = 28) received the treatment and coaching (Intervention group), group 2 (n = 28) received the treatment with the device turned off and coaching (Placebo group) and group 3 (n = 28) received coaching only (Control group). The data were collected at baseline, and after 6, 12 and 24 weeks. The primary outcome was % return to work, and secondary outcomes were work-related fatigue (emotional exhaustion and need for recovery after work), stress (distress and hair cortisol), and quality of life (SF-36 dimensions: vitality, emotional role limitation, and social functioning). Eighty-four workers completed all measurements, 28 in each group. All groups improved significantly over time in the level of return to work, as well as on all secondary outcomes. No statistical differences between the three groups were found either on the primary outcome or on any of the secondary outcomes. Light therapy with Pulsed Electro Magnetic Fields PEMF therapy has no additional effect on return to work, stress, fatigue, and quality of live compared to coaching alone. NTR4794 , registration date: 18-sep-2014.

  4. Field Trial of the Enhanced Data Authentication System (EDAS)

    Energy Technology Data Exchange (ETDEWEB)

    Thomas, Maikael A.; Baldwin, George T.; Hymel, Ross W

    2016-05-01

    The goal of the field trial of EDAS was to demonstrate the utility of secure branching of operator instrumentation for nuclear safeguards, identify any unforeseen implementation and application issues with EDAS, and confirm whether the approach is compatible with operator concerns and constraints.

  5. Large scale photovoltaic field trials. Second technical report: monitoring phase

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2007-09-15

    This report provides an update on the Large-Scale Building Integrated Photovoltaic Field Trials (LS-BIPV FT) programme commissioned by the Department of Trade and Industry (Department for Business, Enterprise and Industry; BERR). It provides detailed profiles of the 12 projects making up this programme, which is part of the UK programme on photovoltaics and has run in parallel with the Domestic Field Trial. These field trials aim to record the experience and use the lessons learnt to raise awareness of, and confidence in, the technology and increase UK capabilities. The projects involved: the visitor centre at the Gaia Energy Centre in Cornwall; a community church hall in London; council offices in West Oxfordshire; a sports science centre at Gloucester University; the visitor centre at Cotswold Water Park; the headquarters of the Insolvency Service; a Welsh Development Agency building; an athletics centre in Birmingham; a research facility at the University of East Anglia; a primary school in Belfast; and Barnstable civic centre in Devon. The report describes the aims of the field trials, monitoring issues, performance, observations and trends, lessons learnt and the results of occupancy surveys.

  6. A field trial on the effects of algae addition to calf feed. Project T2014

    NARCIS (Netherlands)

    Elissen, H.J.H.; Berg, van den W.; Kootstra, A.M.J.

    2015-01-01

    This report describes a field trial that took place between 1 July and 2 October 2015 at a Dutch rose veal farm in which a group of 30 calves was fed with formula milk of which 2% of the dry matter was substituted with concentrated freshwater algae. The control group consisted of 25 calves. The farm

  7. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

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

  8. Design and Management of Field Trials of Transgenic Cereals

    Science.gov (United States)

    Bedő, Zoltán; Rakszegi, Mariann; Láng, László

    The development of gene transformation systems has allowed the introgression of alien genes into plant genomes, thus providing a mechanism for broadening the genetic resources available to plant breeders. The design and the management of field trials vary according to the purpose for which transgenic cereals are developed. Breeders study the phenotypic and genotypic stability of transgenic plants, monitor the increase in homozygosity of transgenic genotypes under field conditions, and develop backcross generations to transfer the introduced genes into secondary transgenic cereal genotypes. For practical purposes, they may also multiply seed of the transgenic lines to produce sufficient amounts of grain for the detailed analysis of trait(s) of interest, to determine the field performance of transgenic lines, and to compare them with the non-transformed parental genotypes. Prior to variety registration, the Distinctness, Uniformity and Stability (DUS) tests and Value for Cultivation and Use (VCU) experiments are carried out in field trials. Field testing includes specific requirements for transgenic cereals to assess potential environmental risks. The capacity of the pollen to survive, establish and disseminate in the field test environment, the potential for gene transfer, the effects of products expressed by the introduced sequences and phenotypic and genotypic instability that might cause deleterious effects must all be specifically monitored, as required by EU Directives 2003/701/EC (1) on the release of genetically modified higher plants in the environment.

  9. Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform

    Directory of Open Access Journals (Sweden)

    S. Kannan

    2016-03-01

    Conclusion: The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these trials and more support from various organizations.

  10. Note on field trials of a new prototype solar still

    Energy Technology Data Exchange (ETDEWEB)

    Anand, S P

    1977-01-01

    Observations on field trials of a prototype still, of modified design, with respect to the quantity and quality of the fresh water obtained are reported. An average yield of 3.6 liters/m/sup 2//day of fresh water was obtained during the post-monsoon season and winter months. Traces of dissolved copper, zinc and iron were observed in the distilled water and the causes of metallic contamination are discussed. 10 references.

  11. Relevance of randomised controlled trials in oncology.

    Science.gov (United States)

    Tannock, Ian F; Amir, Eitan; Booth, Christopher M; Niraula, Saroj; Ocana, Alberto; Seruga, Bostjan; Templeton, Arnoud J; Vera-Badillo, Francisco

    2016-12-01

    Well-designed randomised controlled trials (RCTs) can prevent bias in the comparison of treatments and provide a sound basis for changes in clinical practice. However, the design and reporting of many RCTs can render their results of little relevance to clinical practice. In this Personal View, we discuss the limitations of RCT data and suggest some ways to improve the clinical relevance of RCTs in the everyday management of patients with cancer. RCTs should ask questions of clinical rather than commercial interest, avoid non-validated surrogate endpoints in registration trials, and have entry criteria that allow inclusion of all patients who are fit to receive treatment. Furthermore, RCTs should be reported with complete accounting of frequency and management of toxicities, and with strict guidelines to ensure freedom from bias. Premature reporting of results should be avoided. The bar for clinical benefit should be raised for drug registration, which should require publication and review of mature data from RCTs, post-marketing health outcome studies, and value-based pricing. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Field dodder – How to control it?

    Directory of Open Access Journals (Sweden)

    Marija Sarić-Krsmanović

    2015-04-01

    Full Text Available Broad geographic distribution and spectrum of hosts make field dodder, Cuscuta campestris, one of the most widespread and most harmful pests among flowering parasitic plants. Field dodder may become a problem in vegetable nurseries (e.g. tomato, sweet pepper and cabbage or in potato or some other crop grown in plastic greenhouses. However, the most devastating damage comes from field dodder outbreaks in newly-established perennial legume crops (alfalfa, clover, etc., which are generally the preferred hosts of this parasitic flowering species. Apart from alfalfa and clover, an expansion of field dodder has been observed in recent years in sugar beet, too. Different measures are available for controlling field dodder, from preventive (pure seeding material, tolerant cultivars, etc., to mechanical removal (mowing and hand weeding to herbicide treatments. The most successful control of field dodder requires a systematic approach ensured through integrated protection, which contributes to a more effective control of parasitic flowering plants.

  13. Evaluation of field trials of innovative practices in science education

    OpenAIRE

    Gerloff-Gasser, C; Büchel, K

    2012-01-01

    Science and technology (S&T) education is vital to increase the science literacy in modern societies and to stimulate more young people to opt for careers in S&T. Because there are considerable differences in S&T education among and sometimes within countries, it is promising to adopt an adaptive strategy to its innovation that allows a fit to the specific conditions of each of the countries. In this report, we present first results of field trials with innovative practices in S&T educatio...

  14. US genetic regulations: bacterial field trial to go ahead.

    Science.gov (United States)

    Budiansky, S

    The National Institutes of Health's Recombinant DNA Advisory Committee (RAC) has approved a commercial proposal by Advanced Genetic Sciences Inc. to field-test recombinant ice-nucleating bacteria. Its decision came two weeks after a federal judge halted a similar trial by researchers from the University of California at Berkeley, and barred RAC from approving other federally-funded research that would release genetically-engineered organisms into the environment. The ruling, which resulted from an action filed by activist Jeremy Rifkin, exempted privately-funded research. RAC will continue to review commercial proposals, which are submitted voluntarily and are not legally bound by the committee decisions.

  15. PV domestic field trial. Third annual technical report

    Energy Technology Data Exchange (ETDEWEB)

    Crick, F.; Davies, N.; Munzinger, M.; Pearsall, N.; Martin, C.

    2004-07-01

    This report summaries the results of a field trials investigating the design, construction and operation of photovoltaic (PV) systems installed during 2003 to provide information for utilities, building developers and those involved in PV installations and operations. Topics examined include the appearance of the systems, their architectural integration, the different fixing methods, the cost effectiveness of the systems, problems encountered, and monitoring activities. Key issues discussed include communication and co-ordination between interested bodies, siting and location, and good practice. Details are given of monitoring inspection visits, and performance analysis.

  16. [Damage control in field surgery].

    Science.gov (United States)

    Samokhvalov, I M; Manukovskiĭ, V A; Badalov, V I; Severin, V V; Golovko, K P; Denisenko, V V

    2011-09-01

    Damage control surgery (DCS) is an important option in the store of war surgery and surgery of trauma. The main purpose of our investigation was to specify the percentage of the injured who need DCS. We performed retrospective study of the patients in the combat operations in Chechnya (1994-2002) and in peacetime (2005-2010). Total lethality in group with the standard surgical approach was 62.3%. It was significantly higher than the lethality in group of patients who underwent DCS - 50.0% (p < 0.05). Thus, the experience of DCS in War Surgery Department confirms that DCS is perspective tendency in treatment of patients with severe and extremely severe trauma, and allows decreasing lethality in 12.3%.

  17. Randomised controlled trial of mesalazine in IBS.

    Science.gov (United States)

    Barbara, Giovanni; Cremon, Cesare; Annese, Vito; Basilisco, Guido; Bazzoli, Franco; Bellini, Massimo; Benedetti, Antonio; Benini, Luigi; Bossa, Fabrizio; Buldrini, Paola; Cicala, Michele; Cuomo, Rosario; Germanà, Bastianello; Molteni, Paola; Neri, Matteo; Rodi, Marcello; Saggioro, Alfredo; Scribano, Maria Lia; Vecchi, Maurizio; Zoli, Giorgio; Corinaldesi, Roberto; Stanghellini, Vincenzo

    2016-01-01

    Low-grade intestinal inflammation plays a role in the pathophysiology of IBS. In this trial, we aimed at evaluating the efficacy and safety of mesalazine in patients with IBS. We conducted a phase 3, multicentre, tertiary setting, randomised, double-blind, placebo-controlled trial in patients with Rome III confirmed IBS. Patients were randomly assigned to either mesalazine, 800 mg, or placebo, three times daily for 12 weeks, and were followed for additional 12 weeks. The primary efficacy endpoint was satisfactory relief of abdominal pain/discomfort for at least half of the weeks of the treatment period. The key secondary endpoint was satisfactory relief of overall IBS symptoms. Supportive analyses were also performed classifying as responders patients with a percentage of affirmative answers of at least 75% or >75% of time. A total of 185 patients with IBS were enrolled from 21 centres. For the primary endpoint, the responder patients were 68.6% in the mesalazine group versus 67.4% in the placebo group (p=0.870; 95% CI -12.8 to 15.1). In explorative analyses, with the 75% rule or >75% rule, the percentage of responders was greater in the mesalazine group with a difference over placebo of 11.6% (p=0.115; 95% CI -2.7% to 26.0%) and 5.9% (p=0.404; 95% CI -7.8% to 19.4%), respectively, although these differences were not significant. For the key secondary endpoint, overall symptoms improved in the mesalazine group and reached a significant difference of 15.1% versus placebo (p=0.032; 95% CI 1.5% to 28.7%) with the >75% rule. Mesalazine treatment was not superior than placebo on the study primary endpoint. However, a subgroup of patients with IBS showed a sustained therapy response and benefits from a mesalazine therapy. ClincialTrials.gov number, NCT00626288. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  18. Do randomized controlled trials discuss healthcare costs?

    Directory of Open Access Journals (Sweden)

    G Michael Allan

    Full Text Available BACKGROUND: Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. METHODS AND FINDINGS: We randomly sampled 188 RCTs spanning three years (2003-2005 from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188 of RCTs; any actual costs were included in 7.4% (14/188 of RCTs; and any mention of costs was included in 27.7% (52/188 of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005 and any mention of costs (Cochran-Armitage test, p = 0.02. Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009 or any mention of costs (OR = 0.63, p = 0.02. Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. CONCLUSION: While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

  19. Do randomized controlled trials discuss healthcare costs?

    Science.gov (United States)

    Allan, G Michael; Korownyk, Christina; LaSalle, Kate; Vandermeer, Ben; Ma, Victoria; Klein, Douglas; Manca, Donna

    2010-08-23

    Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs) routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. We randomly sampled 188 RCTs spanning three years (2003-2005) from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188) of RCTs; any actual costs were included in 7.4% (14/188) of RCTs; and any mention of costs was included in 27.7% (52/188) of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005) and any mention of costs (Cochran-Armitage test, p = 0.02). Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009) or any mention of costs (OR = 0.63, p = 0.02). Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

  20. Trial manufacture of ITER toroidal field coil radial plate

    International Nuclear Information System (INIS)

    Takano, Katsutoshi; Koizumi, Norikiyo; Shimizu, Tatsuya; Nakajima, Hideo; Esaki, Koichi; Nagamoto, Yoshifumi; Makino, Yoshinobu

    2012-01-01

    In an ITER toroidal field (TF) coil, tight tolerances of 1 mm in flatness and a few millimeters in profile are required to manufacture a radial plate (RP), although the height and width of the RP are 13 m and 9 m, respectively. In addition, since cover plates (CPs) should be fitted to a groove in the RP with tolerance of 0.5 mm, tight tolerances are also required for the CPs. The authors therefore performed preliminary and full-scale trials to achieve tight tolerances that meet the required RP manufacturing schedule, such as one RP every three weeks. Before the full-scale trials, preliminary trials were performed to optimize machining procedures, welding conditions and assembly procedures for the RP, and the manufacturing processes for the straight and curved CP segments. Based on these preliminary trial results, full-scale RP and CPs were fabricated. The flatness achieved for the RP is 1 mm, except at the top and bottom where gravity support is insufficient. If the gravity support is suitable, it is expected that a flatness of 1 mm is achievable. The profile of the RP was measured to be within the targeted range, better than 2 mm. In addition, most of the CPs fit the corresponding groove of the RP. Although the issue of hot-cracking in the weld still remains, the test results indicate that this problem can be prevented by improving the geometry of the welding joint. Thus, we can conclude that the manufacturing procedures for RP and CP have been demonstrated. (author)

  1. Programming the control of magnetic field measurements

    International Nuclear Information System (INIS)

    David, L.

    1998-01-01

    This paper gives a short review concerning the new NMR probe measurement control system. Then it presents the new program 'CYCLOCHAMP' attached to the magnetic field measurement which also allows to cycle the magnetic field inside the cyclotrons and to equilibrate it among the SSC sectors. (authors)

  2. Acupuncture and asthma: a review of controlled trials

    NARCIS (Netherlands)

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

    1991-01-01

    BACKGROUND: Published controlled trials of acupuncture in asthma have often contained a small number of subjects and the results are contradictory. Controlled trials have been reviewed to determine whether clearer conclusions could be obtained by assessing as many studies as possible according to

  3. Opioid detoxification : from controlled clinical trial to clinical practice

    NARCIS (Netherlands)

    Dijkstra, Boukje A G; De Jong, Cor A J; Wensing, Michel; Krabbe, Paul F M; van der Staak, Cees P F

    2010-01-01

    Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results

  4. DSSHerbicide: Herbicide field trials in winter wheat. How to come to a decision

    Directory of Open Access Journals (Sweden)

    Sefzat, David

    2014-02-01

    Full Text Available Herbicide decision support systems can calculate efficient, economically optimized herbicide mixtures with reduced dosages, if field specific weed data are given. Thus, they can be a sensible tool for integrated weed control. However, advises of decision support systems have to be tested before introducing them into practical farming. In Mecklenburg-Vorpommern two herbicide field trials were installed with four different prototypes of decision support systems. An untreated plot and three expert advices, private advisors, official advisory service and a farmer decision, were included as additional test variables. Herbicide efficacies in autumn, weed dry matter after spring applications, herbicide costs and wheat yield were measured to evaluate the decision support system prototypes. In one field trial with low weed density before treatments efficacies were at least 85%. In two prototypes efficacies were lower than in the expert plots. No significant differences between decision variables were found regarding weed dry matter after spraying in spring. On this site, herbicide costs were higher when expert advises were used compared to decision support system advises. No significant differences were detected in yield. Even yield in “untreated” was not significantly different. The second field trial carried higher weed densities. Here herbicide efficacies were lower in all treatments. Poa annua and Matricaria recutita were significantly affected by the treatments resulting from the decision tools. However, these differences did not result in statistically different weed dry matter or wheat yield. Three of the prototypes advised solutions with very low herbicide costs in autumn, but high costs in spring. As a result, total weed costs in these plots were higher than in the plots advised by experts. It is concluded from the field trials, that different prototypes of decision support systems are giving sensible herbicide advice. In fields with low

  5. Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial.

    Science.gov (United States)

    Shukla, Vivek V; Bansal, Satvik; Nimbalkar, Archana; Chapla, Apurva; Phatak, Ajay; Patel, Dipen; Nimbalkar, Somashekhar

    2018-04-15

    To compare individual efficacy and additive effects of pain control interventions in preterm neonates. Randomized controlled trial. Level-3 University affiliated neonatal intensive care unit. 200 neonates (26-36 wk gestational age) requiring heel-prick for bedside glucose assessment. Exclusion criteria were neurologic impairment and critical illness precluding study interventions. Neonates were randomly assigned to Kangaroo mother care with Music therapy, Music therapy, Kangaroo Mother care or Control (no additional intervention) groups. All groups received expressed breast milk with cup and spoon as a baseline pain control intervention. Assessment of pain using Premature Infant Pain Profile (PIPP) score on recorded videos. The mean (SD) birth weight and gestational age of the neonates was 1.9 (0.3) kg and 34 (2.3) wk, respectively. Analysis of variance showed significant difference in total PIPP score across groups (P<0.001). Post-hoc comparisons using Sheffe's test revealed that the mean (SD) total PIPP score was significantly lower in Kangaroo mother care group [7.7 (3.9) vs. 11.5 (3.4), 95% CI(-5.9, -1.7), P<0.001] as well as Kangaroo mother care with Music therapy group [8.5 (3.2) vs. 11.5 (3.4), 95%CI (-5.1, -0.9), P=0.001] as compared to Control group. PIPP score was not significantly different between Control group and Music therapy group. Kangaroo mother care with and without Music therapy (with expressed breast milk) significantly reduces pain on heel-prick as compared to expressed breast milk alone. Kangaroo mother care with expressed breast milk should be the first choice as a method for pain control in preterm neonates.

  6. Field dodder (Cuscuta campestris) control with flumioxazin

    Science.gov (United States)

    Field dodder is an important weed in alfalfa grown for seed production, requiring stringent control to keep the alfalfa seed free of dodder seed contamination. Pendimethalin has been the primary tool used to control dodder in alfalfa seed production for over 25 years. Flumioxazin was recently regis...

  7. Strong field control of predissociation dynamics.

    Science.gov (United States)

    Corrales, María E; Balerdi, Garikoitz; Loriot, Vincent; de Nalda, Rebeca; Bañares, Luis

    2013-01-01

    Strong field control scenarios are investigated in the CH3I predissociation dynamics at the origin of the second absorption B-band, in which state-selective electronic predissociation occurs through the crossing with a valence dissociative state. Dynamic Stark control (DSC) and pump-dump strategies are shown capable of altering both the predissociation lifetime and the product branching ratio.

  8. Mean Field Type Control with Congestion

    Energy Technology Data Exchange (ETDEWEB)

    Achdou, Yves, E-mail: achdou@ljll.univ-paris-diderot.fr; Laurière, Mathieu [Univ. Paris Diderot, Sorbonne Paris Cité, Laboratoire Jacques-Louis Lions, UMR 7598, UPMC, CNRS (France)

    2016-06-15

    We analyze some systems of partial differential equations arising in the theory of mean field type control with congestion effects. We look for weak solutions. Our main result is the existence and uniqueness of suitably defined weak solutions, which are characterized as the optima of two optimal control problems in duality.

  9. Passive drainage and biofiltration of landfill gas: Australian field trial

    International Nuclear Information System (INIS)

    Dever, S.A.; Swarbrick, G.E.; Stuetz, R.M.

    2007-01-01

    In Australia a significant number of landfill waste disposal sites do not incorporate measures for the collection and treatment of landfill gas. This includes many old/former landfill sites, rural landfill sites, non-putrescible solid waste and inert waste landfill sites, where landfill gas generation is low and it is not commercially viable to extract and beneficially utilize the landfill gas. Previous research has demonstrated that biofiltration has the potential to degrade methane in landfill gas, however, the microbial processes can be affected by many local conditions and factors including moisture content, temperature, nutrient supply, including the availability of oxygen and methane, and the movement of gas (oxygen and methane) to/from the micro-organisms. A field scale trial is being undertaken at a landfill site in Sydney, Australia, to investigate passive drainage and biofiltration of landfill gas as a means of managing landfill gas emissions at low to moderate gas generation landfill sites. The design and construction of the trial is described and the experimental results will provide in-depth knowledge on the application of passive gas drainage and landfill gas biofiltration under Sydney (Australian) conditions, including the performance of recycled materials for the management of landfill gas emissions

  10. Field Trial Measurements to Validate a Stochastic Aircraft Boarding Model

    Directory of Open Access Journals (Sweden)

    Michael Schultz

    2018-03-01

    Full Text Available Efficient boarding procedures have to consider both operational constraints and the individual passenger behavior. In contrast to the aircraft handling processes of fueling, catering and cleaning, the boarding process is more driven by passengers than by airport or airline operators. This paper delivers a comprehensive set of operational data including classification of boarding times, passenger arrival times, times to store hand luggage, and passenger interactions in the aircraft cabin as a reliable basis for calibrating models for aircraft boarding. In this paper, a microscopic approach is used to model the passenger behavior, where the passenger movement is defined as a one-dimensional, stochastic, and time/space discrete transition process. This model is used to compare measurements from field trials of boarding procedures with simulation results and demonstrates a deviation smaller than 5%.

  11. Solar field control for desalination plants

    Energy Technology Data Exchange (ETDEWEB)

    Roca, Lidia [Convenio Universidad de Almeria, Plataforma Solar de Almeria, Ctra. Senes s/n, 04200 Tabernas, Almeria (Spain); Berenguel, Manuel [Universidad de Almeria, Dpto. Lenguajes y Computacion, Ctra. Sacramento s/n, 04120 Almeria (Spain); Yebra, Luis; Alarcon-Padilla, Diego C. [CIEMAT, Plataforma Solar de Almeria, Ctra. Senes s/n, 04200 Tabernas, Almeria (Spain)

    2008-09-15

    This paper presents the development and application of a feedback linearization control strategy for a solar collector field supplying process heat to a multi-effect seawater distillation plant. Since one objective is to use as much as possible the solar resource, control techniques can be used to produce the maximum heat process in the solar field. The main purpose of the controller presented in this paper is to manipulate the water flow rate to maintain an outlet-inlet temperature gradient in the collectors, thereby ensuring continuous process heating, or in other words, continuous production of fresh water in spite of disturbances. The dynamic behaviour of this solar field was approximated by a simplified lumped-parameters nonlinear model based on differential equations, validated with real data and used in the feedback linearization control design. Experimental results in the seawater desalination plant at the Plataforma Solar de Almeria (Spain) show good agreement of the model and real data despite the approximations included. Moreover, by using feedback linearization control it is possible to track a constant gradient temperature reference in the solar field with good results. (author)

  12. Field trial of a pulsed limestone diversion well

    Science.gov (United States)

    Sibrell, Philip L.; Denholm, C.; Dunn, Margaret

    2013-01-01

    The use of limestone diversion wells to treat acid mine drainage (AMD) is well-known, but in many cases, acid neutralization is not as complete as would be desired. Reasons for this include channeling of the water through the limestone bed, and the slow reaction rate of the limestone gravel. A new approach to improve the performance of the diversion well was tested in the field at the Jennings Environmental Education Center, near Slippery Rock, PA. In this approach, a finer size distribution of limestone was used so as to allow fluidization of the limestone bed, thus eliminating channeling and increasing particle surface area for faster reaction rates. Also, water flow was regulated through the use of a dosing siphon, so that consistent fluidization of the limestone sand could be achieved. Testing began late in the summer of 2010, and continued through November of 2011. Initial system performance during the 2010 field season was good, with the production of net alkaline water, but hydraulic problems involving air release and limestone sand retention were observed. In the summer of 2011, a finer size of limestone sand was procured for use in the system. This material fluidized more readily, but acid neutralization tapered off after several days. Subsequent observations indicated that the hydraulics of the system was compromised by the formation of iron oxides in the pipe leading to the limestone bed, which affected water distribution and flow through the bed. Although results from the field trial were mixed, it is believed that without the formation of iron oxides and plugging of the pipe, better acid neutralization and treatment would have occurred. Further tests are being considered using a different hydraulic configuration for the limestone sand fluidized bed.

  13. Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial.

    Science.gov (United States)

    Fleischmann, Robert; Decker, Anne-Marie; Kraft, Antje; Mai, Knut; Schmidt, Sein

    2017-12-01

    Regulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity. This study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and randomly allocated to enter cross-sectional data obtained during routine visits either through pCRF or eCRF. A balanced randomization list was generated before enrolment commenced. 90 and 30 records were gathered for the time that 27 patients and 2 study nurses required to report 2025 and 2037 field values, respectively. The primary hypothesis, that eCRF use is faster than pCRF use, was tested by a two-tailed t-test. Analysis of variance and covariance were used to evaluate predictors of entry performance. Data integrity was evaluated by descriptive statistics. All randomized patients were included in the study (eCRF group n = 13, pCRF group n = 14). eCRF, as compared to pCRF, data collection was associated with significant time savings  across all conditions (8.29 ± 5.15 min vs. 10.54 ± 6.98 min, p = .047). This effect was not defined by participant type, i.e. patients or study nurses (F (1,112)  = .15, p = .699), CRF length (F (2,112)  = .49, p = .609) or patient age (Beta = .09, p = .534). Additional 5.16 ± 2.83 min per CRF were saved with eCRFs due to data transcription redundancy when patients answered questionnaires directly in eCRFs. Data integrity was

  14. Field trials on the store dressing with rock phosphate

    Directory of Open Access Journals (Sweden)

    Pentti Hänninen

    1960-01-01

    Full Text Available The possibility of improving the soil phosphorus status by a store dressing with rock phosphate has been studied in two field trials of five years standing. Hyperphosphate Reno was applied to the nurse crop of a red clover-timothy ley in amounts of 0, 1000 kg/ha, or 2000 kg/ha, respectively. The split-plot technique was used to study the response of the ley to an additional annual application of 200 kg/ha of superphosphate. The soil analyses distinctly proved that, in spite of a careful working in of the hyperphosphate with a spade harrow, the fertilizer had not penetrated deeper than to the layer from 1 to 3 inches, with a large part of it remaining in the top inch. The treatment with hyperphosphate had mostly increased the fraction of the calcium-bound phosphorus, and, to a very low degree, the aluminium-bound phosphorus. The effect of superphosphate could be detected only in the fractions of aluminium- and iron-bound phosphorus of the surface inch. Although the store dressing did not produce marked responses in the yields of either trial, the statistically significant negative interaction between the effect of it and of superphosphate may be taken to indicate that hyperphosphate was able to improve the phosphorus status of these soils to some degree. The analyses of the hay samples from one of the trials in the fifth experimental year showed that the store dressing, particularly with the higher amount of hyperphosphate was able to increase the phosphorus content of hay to a satisfactory level which was equal to that produced by the annual superphosphate dressing only. Their combined effect resulted in the production of hay dry matter containing more than 0.24 % of P. In one of the experiments the residual effect of the treatments on rye was studied. The response to superphosphate was highly significant, probably owing to the high demands of phosphorus by rye, connected with the overwintering conditions, and also to the fact that ploughing in

  15. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    Science.gov (United States)

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  16. Randomized controlled trials of COX-2 inhibitors

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; De Bruin, Marie L; Knol, Mirjam J

    2011-01-01

    trials after the 2004 market withdrawal of rofecoxib were excluded. RESULTS: Median defined daily dose (DDD) of celecoxib (2.00) was higher than the median DDD of rofecoxib (1.00; p ... celecoxib after the withdrawal of rofecoxib because the overall median DDD of celecoxib was substantially higher than the median DDD of rofecoxib, while non-selective NSAID DDDs were comparable....

  17. Publication status of contemporary oncology randomised controlled trials worldwide.

    Science.gov (United States)

    Chen, Yu-Pei; Liu, Xu; Lv, Jia-Wei; Li, Wen-Fei; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

    2016-10-01

    Little is known about the extent of selective publication in contemporary oncology randomised controlled trials (RCTs) worldwide. This study aimed to evaluate the rates of publication and timely publication (within 24 months) for contemporary oncology RCTs from all over the world. We also investigated the trial characteristics associated with publication and timely publication. We identified all phase III oncology RCTs registered on ClinicalTrials.gov with a primary completion date between January 2008 and December 2012. We searched PubMed and EMBASE to identify publications. The final search date was 31 December 2015. Our primary outcome measure was the time to publication from the primary completion date to the date of primary publication in a peer-reviewed journal. We identified 598 completed oncology RCTs; overall, 398 (66.6%) had been published. For published trials, the median time to publication was 25 months (interquartile range, 16-37 months). Only 192 trials (32.1%) were published within 24 months. Timely publication was independently associated with trials completed late in 2012. Trials conducted in Asia and other regions were less likely to have timely publication, but trials conducted in different locations were all equally likely to be published. Industry- and NIH-funded trials were equally likely to be published timely or at any time after trial completion. Among 391 published trials with clear primary outcomes, there was a trend for timely publication of positive trials compared with negative trials. Despite the ethical obligations and societal expectations of disclosing findings promptly, oncology RCTs performed poorly. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

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

  19. Field bus technology in accelerator control systems

    International Nuclear Information System (INIS)

    Tang Shuming

    1999-01-01

    Since eighties to now, the computer technology, network communication and ULSI technology have been developing rapidly. The level of control for industries and scientific experiments has been upgraded accordingly, so as to meet the increasing requirements for automation. The control systems become more complicated; the devices in control systems become more and more intelligent. However the cost of DCS (Distributed Control System) is quite expensive and the period of system integration is very long. More than ten measurement results for two methods defined in the world, in order to get inter operability of intelligent devices and reduce the costs. The author presents the development trend of fieldbuses briefly and describes the main performances of CAN, LONWORKS, WOLDFIP and PROFIBUS which are mainly used in the world today. The author proposes that the field bus technology will be introduced into the accelerator control systems in the country

  20. Joint remote data transmission field trial at Ahaus

    International Nuclear Information System (INIS)

    Pekkarinen, J.; Meylemans, P.; Rudolf, K.; Schink, F.J.; Kuribayashi, T.; Leslie, R.F.; Neumann, G.

    2001-05-01

    The international safeguards authorities Euratom Safeguards Office and international atomic energy agency (IAEA) intend to improve the effectiveness and efficiency of their inspection efforts in nuclear facilities by replacing unattended remote monitoring technology for on-site inspection activities. In order to study aspects of cost-effectiveness as well as technical feasibility and reliability, a 13-month dedicated field trial was performed at the Ahaus spent fuel storage facility testing the remote retrieval of authenticated and encrypted image data files from a digital multi-camera optical surveillance system (DMOS) with three cameras. Each image data file was released with a delay of 24 hours for remote retrieval via ISDN. Retrieval, reviewing and archiving took place at Euratom headquarters in Luxembourg. Due to the applied distributed data storage concept no loss of data took place. The data reduction principle of front end scene change detection worked reliably, i.e. it was possible to significantly reduce the amount of data to be remotely transmitted and the associated transmission costs. Under the assumption that technically mature safeguards instrumentation is available, the implementation of remote monitoring systems is technically feasible but requires cost-benefit analyses on a case-by-case basis. (orig.) [de

  1. Reducing Reforestation Costs in Lebanon: Adaptive Field Trials

    Directory of Open Access Journals (Sweden)

    Garabet (Garo Haroutunian

    2017-05-01

    Full Text Available Lebanon’s Ministry of Environment initiated a project in 2009 to determine low-cost reforestation techniques for stone pine (Pinus pinea and Lebanon cedar (Cedrus libani for large-scale land rehabilitation activities in the arid Middle East. Irrigation (several techniques vs. no water, planting (8- to 18-month-old seedlings, seeding, and soil preparation methods were evaluated in three sets of adaptive management field trials. The aim was to reduce reforestation costs while still achieving sufficient regeneration. A key result for management was that non-irrigated seed planting of stone pine and possibly of Lebanon cedar showed promise for cost-effective reforestation and could be competitive with seedlings, given correct seed source and planting conditions. Stone pine seeds collected from nearby mother trees and planted without irrigation on sandy soil showed 35% survival for <600 USD/ha; seedlings planted without irrigation cost about 2500 USD/ha and achieved 50–70% survival (costs based on 800 seedlings/ha. Water supplements increased establishment costs over 2 years without concomitant improvements to survival. Future studies should evaluate how soil texture and soil preparation interact with other factors to affect seed germination and survival for each species.

  2. Heat treatment trials for ITER toroidal field coils

    International Nuclear Information System (INIS)

    Matsui, Kunihiro; Hemmi, Tsutomu; Koizumi, Norikiyo; Nakajima, Hideo; Kimura, Satoshi; Nakamoto, Kazunari

    2012-01-01

    Cable-in-conduit (CIC) conductors using Nb 3 Sn strands are used in ITER toroidal fields (TF) coils. Heat treatment generates thermal strain in CIC conductors because of the difference in thermal expansion between the Nb 3 Sn strands and the stainless-steel jacket. The elongation/shrinkage of the TF conductor may make it impossible to insert a wound TF conductor into the groove of a radial plate. In addition, it is expected that the deformation of the winding due to heat treatment-based release of the residual force in the jacket may also make it impossible to insert the winding in the groove, and that correcting the winding geometry to allow insertion of the winding may influence the superconducting performance of the TF conductor. The authors performed several trials using heat treatment as the part of activities in Phase II of TF coil procurement aiming to resolve the above-mentioned technical issues, and evaluated the elongations of 0.064, 0.074 and 0.072% for the straight and curved conductors and 1/3-scale double-pancake (DP) winding, respectively. It was confirmed that correction if the deformed winding did not influence the superconducting performance of the conductor. (author)

  3. Not a load of rubbish: simulated field trials in large-scale containers.

    Science.gov (United States)

    Hohmann, M; Stahl, A; Rudloff, J; Wittkop, B; Snowdon, R J

    2016-09-01

    Assessment of yield performance under fluctuating environmental conditions is a major aim of crop breeders. Unfortunately, results from controlled-environment evaluations of complex agronomic traits rarely translate to field performance. A major cause is that crops grown over their complete lifecycle in a greenhouse or growth chamber are generally constricted in their root growth, which influences their response to important abiotic constraints like water or nutrient availability. To overcome this poor transferability, we established a plant growth system comprising large refuse containers (120 L 'wheelie bins') that allow detailed phenotyping of small field-crop populations under semi-controlled growth conditions. Diverse winter oilseed rape cultivars were grown at field densities throughout the crop lifecycle, in different experiments over 2 years, to compare seed yields from individual containers to plot yields from multi-environment field trials. We found that we were able to predict yields in the field with high accuracy from container-grown plants. The container system proved suitable for detailed studies of stress response physiology and performance in pre-breeding populations. Investment in automated large-container systems may help breeders improve field transferability of greenhouse experiments, enabling screening of pre-breeding materials for abiotic stress response traits with a positive influence on yield. © 2016 John Wiley & Sons Ltd.

  4. First Field Trial of Optical Label-Based Switching and Packet Drop on a 477km NTON/Sprint Link

    International Nuclear Information System (INIS)

    Hernandez, V J; Pan, Z; Cao, J; Tsui, V K; Bansal, Y; Fong, S K H; Zhang, Y; Jeon, M Y; Yoo, S J B; Bodtker, B; Bond, S; Lennon, W J; Higashi, H; Lyles, B; McDonald, R

    2001-01-01

    We demonstrate the first field trial of optical label-based wavelength switching and packet drop on 476.8km of the National Transparent Optical Network. Subcarrier multiplexed labels control a switch fabric that includes a tunable wavelength converter and arrayed waveguide grating router

  5. Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology.

    Science.gov (United States)

    Gazzard, Gus; Konstantakopoulou, Evgenia; Garway-Heath, David; Barton, Keith; Wormald, Richard; Morris, Stephen; Hunter, Rachael; Rubin, Gary; Buszewicz, Marta; Ambler, Gareth; Bunce, Catey

    2018-05-01

    The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis. The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication. ISRCTN32038223, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  6. Controlling Casimir force via coherent driving field

    Science.gov (United States)

    Ahmad, Rashid; Abbas, Muqaddar; Ahmad, Iftikhar; Qamar, Sajid

    2016-04-01

    A four level atom-field configuration is used to investigate the coherent control of Casimir force between two identical plates made up of chiral atomic media and separated by vacuum of width d. The electromagnetic chirality-induced negative refraction is obtained via atomic coherence. The behavior of Casimir force is investigated using Casimir-Lifshitz formula. It is noticed that Casimir force can be switched from repulsive to attractive and vice versa via coherent control of the driving field. This switching feature provides new possibilities of using the repulsive Casimir force in the development of new emerging technologies, such as, micro-electro-mechanical and nano-electro-mechanical systems, i.e., MEMS and NEMS, respectively.

  7. Standards for reporting randomized controlled trials in neurosurgery.

    Science.gov (United States)

    Kiehna, Erin N; Starke, Robert M; Pouratian, Nader; Dumont, Aaron S

    2011-02-01

    The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996 to standardize the reporting and improve the quality of clinical trials. Despite having been endorsed by major medical journals and shown to improve the quality of reported trials, neurosurgical journals have yet to formally adopt these reporting criteria. The purpose of this study is to evaluate the quality and reporting of randomized controlled trials (RCTs) in neurosurgery and the factors that may affect the quality of reported trials. The authors evaluated all neurosurgical RCTs published in 2006 and 2007 in the principal neurosurgical journals (Journal of Neurosurgery; Neurosurgery; Surgical Neurology; Journal of Neurology, Neurosurgery, and Psychiatry; and Acta Neurochirurgica) and in 3 leading general medical journals (Journal of the American Medical Association, Lancet, and the New England Journal of Medicine). Randomized controlled trials that addressed operative decision making or the treatment of neurosurgical patients were included in this analysis. The RCT quality was evaluated using the Jadad score and the CONSORT checklist. In 2006 and 2007, 27 RCTs relevant to intracranial neurosurgery were reported. Of these trials, only 59% had a Jadad score ≥ 3. The 3 major medical journals all endorsed the CONSORT guidelines, while none of the neurosurgical journals have adopted these guidelines. Randomized controlled trials published in the 3 major medical journals had a significantly higher mean CONSORT score (mean 41, range 39-44) compared with those published in neurosurgical journals (mean 26.4, range 17-38; p journals (mean 3.42, range 2-5) than neurosurgical journals (mean 2.45, range 1-5; p = 0.05). Despite the growing volume of RCTs in neurosurgery, the quality of reporting of these trials remains suboptimal, especially in the neurosurgical journals. Improved awareness of the CONSORT guidelines by journal editors, reviewers, and authors of these papers could

  8. From Controlled Trial to Community Adoption: The Multisite Translational Community Trial

    Science.gov (United States)

    Murimi, Mary; Gonzalez, Anjelica; Njike, Valentine; Green, Lawrence W.

    2011-01-01

    Methods for translating the findings of controlled trials, such as the Diabetes Prevention Program, into real-world community application have not been clearly defined. A standardized research methodology for making and evaluating such a transition is needed. We introduce the multisite translational community trial (mTCT) as the research analog to the multisite randomized controlled trial. The mTCT is adapted to incorporate the principles and practices of community-based participatory research and the increased relevance and generalizability gained from diverse community settings. The mTCT is a tool designed to bridge the gap between what a clinical trial demonstrates can work in principle and what is needed to make it workable and effective in real-world settings. Its utility could be put to the test, in particular with practice-based research networks such as the Prevention Research Centers. PMID:21680935

  9. Effects of feedback on residential electricity demand—Findings from a field trial in Austria

    International Nuclear Information System (INIS)

    Schleich, Joachim; Klobasa, Marian; Gölz, Sebastian; Brunner, Marc

    2013-01-01

    This paper analyzes the effects of providing feedback on electricity consumption in a field trial involving more than 1500 households in Linz, Austria. About half of these households received feedback together with information about electricity-saving measures (pilot group), while the remaining households served as a control group. Participation in the pilot group was random, but households were able to choose between two types of feedback: access to a web portal or written feedback by post. Results from cross section OLS regression suggest that feedback provided to the pilot group corresponds with electricity savings of around 4.5% for the average household. Our results from quantile regressions imply that for households in the 30th to the 70th percentile of electricity consumption, feedback on electricity consumption is statistically significant and effects are highest in absolute terms and as a share of electricity consumption. For percentiles below or above this range, feedback appears to have no effect. Finally, controlling for a potential endogeneity bias induced by non random participation in the feedback type groups, we find no difference in the effects of feedback provided via the web portal and by post. - Highlights: • We estimate the effects of feedback on household electricity use in a field trial in Linz, Austria. • Providing feedback on electricity use corresponds with average savings of around 4.5%. • Effects of feedback are most pronounced in the 30th to the 70th percentile. • Feedback provided via a web portal and by post appears equally effective

  10. The Asthma Control Questionnaire as a clinical trial endpoint

    DEFF Research Database (Denmark)

    Barnes, P J; Casale, T B; Dahl, Ronald

    2014-01-01

    these component endpoints; however, there is no consensus on the optimal instrument for use in clinical trials. The Asthma Control Questionnaire (ACQ) has been shown to be a valid, reliable instrument that allows accurate and reproducible assessment of asthma control that compares favourably with other commonly...

  11. 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

  12. Randomised controlled trials in educational research: Ontological ...

    African Journals Online (AJOL)

    based practice in medical and clinical settings because they are associated with a particular ontological and epistemological perspective that is situated within a positivist world view. It assumes that environments and variables can be controlled ...

  13. Heterogenic control groups in randomized, controlled, analgesic trials of total hip and knee arthroplasty.

    Science.gov (United States)

    Karlsen, Anders P; Mathiesen, Ole; Dahl, Jørgen B

    2018-03-01

    Postoperative analgesic interventions are often tested adjunct to basic non-opioid analgesics in randomized controlled trials (RCTs). Consequently, treatment in control groups, and possible assay sensitivity, differs between trials. We hypothesized that postoperative opioid requirements and pain intensities vary between different control groups in analgesic trials. Control groups from RCTs investigating analgesic interventions after total hip and knee arthroplasty were categorized based on standardized basic analgesic treatment. Morphine consumption 0 to 24 hours postoperatively, and resting pain scores at 6 and 24 hours for subgroups of basic treatments, were compared with ANOVA. In an additional analysis, we compared pain and opioid requirements in trials where a non-steroidal anti-inflammatory drug (NSAID) was administered as an intervention with trial where NSAID was administered in a control group. We included 171 RCTs employing 28 different control groups with large variability in pain scores and opioid requirements. Four types of control groups (comprising 78 trials) were eligible for subgroup comparisons. These subgroups received "opioid" alone, "NSAID + opioid", "acetaminophen + opioid", or "NSAID + acetaminophen + opioid", respectively. Morphine consumption and pain scores varied substantially between these groups, with no consistent superior efficacy in any subgroup. Additionally, trials administering NSAID as an intervention demonstrated lower pain scores and opioid requirements than trials where NSAID was administered in a control group. Analgesic treatment in RCT control groups varies considerably. Control groups receiving various combinations of opioid, NSAID and acetaminophen did not differ consistently in pain and opioid requirements. Pain and opioid requirements were lower in trials administering NSAID as an intervention compared with trials administering NSAID in a control group.

  14. Evaluation of Metarhizium anisopliae var. anisopliae Qu-M845 Isolate to Control Varroa destructor (Acari: Varroidae in Laboratory and Field Trials Evaluación del Aislamiento Qu-M845 de Metarhizium anisopliae var. anisopliae para el Control de Varroa destructor (Acari: Varroidae en Ensayos de Laboratorio y Terreno

    Directory of Open Access Journals (Sweden)

    Marta Rodríguez

    2009-12-01

    Full Text Available The effectiveness of the Metarhizium anisopliae (Metschinkoff Qu-M845 isolate was evaluated in laboratory and field trials. It was previously selected for thermal resistance (at 30 and 35 ºC and pathogenicity on Varroa destructor (Anderson and Trueman. In the laboratory, the first evaluations were carried out by spraying and increasing the concentration from zero to 10(8 conidia mL-1 on varroa adults. Lethal concentrations required for 50 and 90% mite mortality (LC50 and LC90 were 3.8 x 10(5 and 8 x 10(7 conidia mL-1, respectively (χ2 = 2.03. In the autumn field trials, three application methods (doses of 5 x 10(10 conidia per hive were evaluated. The treatments were: a conidia stamped on filter paper, located on every second frame inside the hive; b dry conidia sprinkled on and between frames; and c dry conidia in a dispenser path at the entrance of the hive. Furthermore, untreated hives were included as controls. After 21 days of treatment, the dry conidia sprinkled on and between frames showed 67% less bees infested by the mite than the control (p La efectividad del aislamiento Qu-M845 de Metarhizium anisopliae (Metschinkoff, seleccionado previamente por su resistencia a temperaturas de 30 y 35 ºC, y patogenicidad sobre Varroa destructor Anderson y Trueman fue evaluada en laboratorio y en ensayos de terreno. Las primeras pruebas consistieron en pulverizar concentraciones crecientes de 0 a 10(8 conidias mL-1 sobre varroas adultas. La concentración letal para matar el 50 y 90% de la población (CL50 y CL90 fueron de 3,8 x 10(5 y 8 x 10(7 conidias mL-1, respectivamente (χ² = 2,03. En otoño se evaluaron en terreno tres métodos de aplicación de una dosis de 5 x 10(10 conidias por colmena. Los tratamientos fueron: a conidias estampadas en papel filtro ubicado cada dos panales móviles al interior de la colmena; b conidias espolvoreadas sobre y entre los panales; y c dispensador de conidias ubicado en la piquera de las colmenas. Además se

  15. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  16. 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

  17. Controlled trial of balneotherapy in treatment of low back pain.

    Science.gov (United States)

    Konrad, K; Tatrai, T; Hunka, A; Vereckei, E; Korondi, I

    1992-01-01

    Three treatments for non-specific lumbar pain--balneotherapy, underwater traction bath, and underwater massage--were assessed in a randomised prospective controlled trial in 158 outpatients. Each group was treated for four weeks and patients were reviewed at the end of this period and at 12 months after entry to the trial. The prescription of analgesics and the pain score were significantly reduced in all three treated groups, but there was no difference between the three groups. No significant change occurred in spinal motion and the straight leg raising test. After one year only the analgesic consumption was significantly lower than in the control group. PMID:1535495

  18. Field trials of 100G and beyond: an operator's point of view

    Science.gov (United States)

    Vorbeck, S.; Schneiders, M.; Weiershausen, W.; Mayer, H.; Schippel, A.; Wagner, P.; Ehrhardt, A.; Braun, R.; Breuer, D.; Drafz, U.; Fritzsche, D.

    2011-01-01

    In this article we present a summary of the latest 100 Gbps field trials in the network of Deutsche Telekom AG with industry partners. We cover a brown field approach as alien wavelength on existing systems, a green field high speed overlay network approach and a high speed interface router-router coupling.

  19. Mindfulness Meditation Training and Executive Control Network Resting State Functional Connectivity: A Randomized Controlled Trial.

    Science.gov (United States)

    Taren, Adrienne A; Gianaros, Peter J; Greco, Carol M; Lindsay, Emily K; Fairgrieve, April; Brown, Kirk Warren; Rosen, Rhonda K; Ferris, Jennifer L; Julson, Erica; Marsland, Anna L; Creswell, J David

    Mindfulness meditation training has been previously shown to enhance behavioral measures of executive control (e.g., attention, working memory, cognitive control), but the neural mechanisms underlying these improvements are largely unknown. Here, we test whether mindfulness training interventions foster executive control by strengthening functional connections between dorsolateral prefrontal cortex (dlPFC)-a hub of the executive control network-and frontoparietal regions that coordinate executive function. Thirty-five adults with elevated levels of psychological distress participated in a 3-day randomized controlled trial of intensive mindfulness meditation or relaxation training. Participants completed a resting state functional magnetic resonance imaging scan before and after the intervention. We tested whether mindfulness meditation training increased resting state functional connectivity (rsFC) between dlPFC and frontoparietal control network regions. Left dlPFC showed increased connectivity to the right inferior frontal gyrus (T = 3.74), right middle frontal gyrus (MFG) (T = 3.98), right supplementary eye field (T = 4.29), right parietal cortex (T = 4.44), and left middle temporal gyrus (T = 3.97, all p < .05) after mindfulness training relative to the relaxation control. Right dlPFC showed increased connectivity to right MFG (T = 4.97, p < .05). We report that mindfulness training increases rsFC between dlPFC and dorsal network (superior parietal lobule, supplementary eye field, MFG) and ventral network (right IFG, middle temporal/angular gyrus) regions. These findings extend previous work showing increased functional connectivity among brain regions associated with executive function during active meditation by identifying specific neural circuits in which rsFC is enhanced by a mindfulness intervention in individuals with high levels of psychological distress. Clinicaltrials.gov,NCT01628809.

  20. Assessing the Effectiveness of Defensive Aid Suite Technology Using a Field Trial and Modelling and Simulation

    National Research Council Canada - National Science Library

    Fournier, Pierre

    2002-01-01

    ...) community that Defensive Aid Suite (DAS) technologies can improve the protection of LAVs. A prototype DAS system was developed by DRDC Valcartier and tested in field trials held in 1995 and 1999...

  1. Use of reflectance confocal microscopy to evaluate 5-fluorouracil 0.5%/salicylic acid 10% in the field-directed treatment of subclinical lesions of actinic keratosis: subanalysis of a Phase III, randomized, double-blind, vehicle-controlled trial.

    Science.gov (United States)

    Ulrich, M; Reinhold, U; Falqués, M; Rodriguez Azeredo, R; Stockfleth, E

    2018-03-01

    Actinic keratosis (AK) is a common skin disorder that can progress to invasive squamous-cell carcinoma. AK can present as clinical (visible) or subclinical (invisible) lesions within areas of chronic sun damage. The importance of treating subclinical AK is gaining support. We present a subanalysis of a previously published Phase III, double-blind, vehicle-controlled study (NCT02289768), to assess 5-fluorouracil (5-FU) 0.5%/salicylic acid 10% treatment of subclinical AK lesions, based on reflectance confocal microscopy (RCM). To determine the efficacy of 5-FU 0.5%/salicylic acid 10% as field-directed treatment for subclinical AK lesions using RCM. For inclusion in this subanalysis, patients had to have at least three subclinical AK lesions within a 25 cm 2 area of skin. Subclinical AK lesions were diagnosed according to the presence of three key RCM criteria: architectural disarray; keratinocyte atypia and pleomorphism at the basal, spinous and granular layer. Subclinical AK lesions were evaluated by RCM at baseline, after 4, 6 and 12 weeks of 5-FU 0.5%/salicylic acid 10% treatment or vehicle, and 8 weeks following the end of treatment. Twenty-seven patients were included: 17 [mean age = 72.2 years, standard deviation (SD) = 6.3] received 5-FU 0.5%/salicylic acid 10% treatment and 10 (mean age = 76.4 years, SD = 3.9) received vehicle. Eight weeks following the end of treatment, the mean number of subclinical lesions declined (from 3.0 at baseline) to 0.3 (95% confidence interval [CI] 0.06-0.57) for the 5-FU 0.5%/salicylic acid 10% group and 1.6 (95% CI 0.52-2.68) in the vehicle group (reductions of 90% [95% CI 72.1-107.1] vs. 47% [95% CI 24.8-69.5], respectively; P = 0.005). The proportion of patients receiving 5-FU 0.5%/salicylic acid 10% showing complete clearance of three preselected subclinical AK lesions was numerically greater than in the vehicle group (69% vs. 40%, respectively; P = 0.183). To the best of our knowledge, this is the first randomized, vehicle-controlled

  2. Bioenergy Ecosystem Land-Use Modelling and Field Flux Trial

    Science.gov (United States)

    McNamara, Niall; Bottoms, Emily; Donnison, Iain; Dondini, Marta; Farrar, Kerrie; Finch, Jon; Harris, Zoe; Ineson, Phil; Keane, Ben; Massey, Alice; McCalmont, Jon; Morison, James; Perks, Mike; Pogson, Mark; Rowe, Rebecca; Smith, Pete; Sohi, Saran; Tallis, Mat; Taylor, Gail; Yamulki, Sirwan

    2013-04-01

    Climate change impacts resulting from fossil fuel combustion and concerns about the diversity of energy supply are driving interest to find low-carbon energy alternatives. As a result bioenergy is receiving widespread scientific, political and media attention for its potential role in both supplying energy and mitigating greenhouse (GHG) emissions. It is estimated that the bioenergy contribution to EU 2020 renewable energy targets could require up to 17-21 million hectares of additional land in Europe (Don et al., 2012). There are increasing concerns that some transitions into bioenergy may not be as sustainable as first thought when GHG emissions from the crop growth and management cycle are factored into any GHG life cycle assessment (LCA). Bioenergy is complex and encapsulates a wide range of crops, varying from food crop based biofuels to dedicated second generation perennial energy crops and forestry products. The decision on the choice of crop for energy production significantly influences the GHG mitigation potential. It is recognised that GHG savings or losses are in part a function of the original land-use that has undergone change and the management intensity for the energy crop. There is therefore an urgent need to better quantify both crop and site-specific effects associated with the production of conventional and dedicated energy crops on the GHG balance. Currently, there is scarcity of GHG balance data with respect to second generation crops meaning that process based models and LCAs of GHG balances are weakly underpinned. Therefore, robust, models based on real data are urgently required. In the UK we have recently embarked on a detailed program of work to address this challenge by combining a large number of field studies with state-of-the-art process models. Through six detailed experiments, we are calculating the annual GHG balances of land use transitions into energy crops across the UK. Further, we are quantifying the total soil carbon gain or

  3. External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants?

    Science.gov (United States)

    Saunders, C; Byrne, C D; Guthrie, B; Lindsay, R S; McKnight, J A; Philip, S; Sattar, N; Walker, J J; Wild, S H

    2013-03-01

    To describe the proportion of people with Type 2 diabetes living in Scotland who meet eligibility criteria for inclusion in several large randomized controlled trials of glycaemic control to inform physicians and guideline developers about the generalizibility of trial results. A literature review was performed to identify large trials assessing the impact of glycaemic control on risk of macrovascular disease. Inclusion and exclusion criteria from each trial were applied to data on the population of people with a diagnosis of Type 2 diabetes living in Scotland in 2008 (n = 180,590) in a population-based cross-sectional study and the number and proportion of people eligible for each trial was determined. Seven trials were identified. The proportion of people with Type 2 diabetes who met the eligibility criteria for the trials ranged from 3.5 to 50.7%. Trial participants were younger at age of diagnosis of diabetes and at time of trial recruitment than in the Scottish study population. The application of upper age criteria excluded the largest proportion of patients, with up to 39% of people with Type 2 diabetes ineligible for a trial with the most stringent criteria based on age alone. We found that many of the large trials of glycaemic control among people with Type 2 diabetes have limited external validity when applied to a population-based cohort of people with Type 2 diabetes. In particular, the age distribution of trial participants often does not reflect that of people with Type 2 diabetes in a contemporary British population. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

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

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

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

  5. Design, analysis and presentation of factorial randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Little Paul

    2003-11-01

    Full Text Available Abstract Background The evaluation of more than one intervention in the same randomised controlled trial can be achieved using a parallel group design. However this requires increased sample size and can be inefficient, especially if there is also interest in considering combinations of the interventions. An alternative may be a factorial trial, where for two interventions participants are allocated to receive neither intervention, one or the other, or both. Factorial trials require special considerations, however, particularly at the design and analysis stages. Discussion Using a 2 × 2 factorial trial as an example, we present a number of issues that should be considered when planning a factorial trial. The main design issue is that of sample size. Factorial trials are most often powered to detect the main effects of interventions, since adequate power to detect plausible interactions requires greatly increased sample sizes. The main analytical issues relate to the investigation of main effects and the interaction between the interventions in appropriate regression models. Presentation of results should reflect the analytical strategy with an emphasis on the principal research questions. We also give an example of how baseline and follow-up data should be presented. Lastly, we discuss the implications of the design, analytical and presentational issues covered. Summary Difficulties in interpreting the results of factorial trials if an influential interaction is observed is the cost of the potential for efficient, simultaneous consideration of two or more interventions. Factorial trials can in principle be designed to have adequate power to detect realistic interactions, and in any case they are the only design that allows such effects to be investigated.

  6. Magnetic field control of fluorescent polymer nanorods

    International Nuclear Information System (INIS)

    Kim, Taehyung; He, Le; Bardeen, Christopher J; Morales, Jason R; Beyermann, W P

    2011-01-01

    Nanoscale objects that combine high luminescence output with a magnetic response may be useful for probing local environments or manipulating objects on small scales. Ideally, these two properties would not interfere with each other. In this paper, we show that a fluorescent polymer host material can be doped with high concentrations of 20–30 nm diameter magnetic γ-Fe 2 O 3 particles and then formed into 200 nm diameter nanorods using porous anodic alumina oxide templates. Two different polymer hosts are used: the conjugated polymer polydioctylfluorene and also polystyrene doped with the fluorescent dye Lumogen Red. Fluorescence decay measurements show that 14% by weight loading of the γ-Fe 2 O 3 nanoparticles quenches the fluorescence of the polydioctylfluorene by approximately 33%, but the polystyrene/Lumogen Red fluorescence is almost unaffected. The three-dimensional orientation of both types of nanorods can be precisely controlled by the application of a moderate strength (∼0.1 T) external field with sub-second response times. Transmission electron microscope images reveal that the nanoparticles cluster in the polymer matrix, and these clusters may serve both to prevent fluorescence quenching and to generate the magnetic moment that rotates in response to the applied magnetic field.

  7. Recent developments in radiation field control technology

    International Nuclear Information System (INIS)

    Wood, C.J.

    1995-01-01

    The U.S. nuclear power industry has been remarkably successful in reducing worker radiation exposures over the past ten years. There has been over a fourfold reduction in the person-rem incurred for each MW.year of electric power generated: from 1.8 in 1980, to only 0.39 person-rems in 1991 and 1992. Preliminary data for 1993 are even lower: approximately 0.37 person-rem.MW.year. Despite this substantial improvement, challenges for the industry remain. Individual exposure limits have been tightened in ICRP 60 and there will be increased requirements for special maintenance work as plants age, suggesting that vigorous efforts with be increased requirements for special maintenance work as plants age, suggesting that vigorous efforts will be required to meet the industry goals for 1995. Reducing out-of-core radiation fields offer the best chance of continuing the downward trend in exposures. To assist utilities select the most economic technology for their specific plants, EPRI has published a manual capturing worldwide operating experience with radiation-field control techniques (TR-100265). No one method will suffice, but implementing suitable combinations from this collection will enable utilities to achieve their exposure goals. Radiation reduction is generally cost-effective: outages are shorter, manpower requirements are reduced and work quality is improved. Despite the up front costs, the benefits over the following 1-3 years typically outweigh the expenses

  8. Recent developments in radiation field control technology

    Energy Technology Data Exchange (ETDEWEB)

    Wood, C.J. [Electric Power Research Institute, Palo Alto, CA (United States)

    1995-03-01

    The U.S. nuclear power industry has been remarkably successful in reducing worker radiation exposures over the past ten years. There has been over a fourfold reduction in the person-rem incurred for each MW.year of electric power generated: from 1.8 in 1980, to only 0.39 person-rems in 1991 and 1992. Preliminary data for 1993 are even lower: approximately 0.37 person-rem.MW.year. Despite this substantial improvement, challenges for the industry remain. Individual exposure limits have been tightened in ICRP 60 and there will be increased requirements for special maintenance work as plants age, suggesting that vigorous efforts with be increased requirements for special maintenance work as plants age, suggesting that vigorous efforts will be required to meet the industry goals for 1995. Reducing out-of-core radiation fields offer the best chance of continuing the downward trend in exposures. To assist utilities select the most economic technology for their specific plants, EPRI has published a manual capturing worldwide operating experience with radiation-field control techniques (TR-100265). No one method will suffice, but implementing suitable combinations from this collection will enable utilities to achieve their exposure goals. Radiation reduction is generally cost-effective: outages are shorter, manpower requirements are reduced and work quality is improved. Despite the up front costs, the benefits over the following 1-3 years typically outweigh the expenses.

  9. The maturation of randomised controlled trials in mental health ...

    African Journals Online (AJOL)

    The aims of this paper are: (i) to give an overview of the use and maturation of randomised controlled trials (RCTs) in mental health services research, (ii) to indicate areas in which mental health may present particular challenges, and (iii) to outline necessary steps to strengthen the capacity to conduct better quality ...

  10. Randomized Controlled Trials: The Most Powerful Tool In Modern ...

    African Journals Online (AJOL)

    Randomized controlled trial (RCT) can be said to be one of the simplest but most powerful tool of research. It is the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost effectiveness of a treatment. Through the randomization, bias will be avoided ...

  11. Yoga for High‑Risk Pregnancy: A Randomized Controlled Trial ...

    African Journals Online (AJOL)

    The study was a single‑blind randomized controlled clinical trial. Perceived stress scale (PSS) was measured during the 12th, 20th, and 28th weeks of pregnancy. SPSS version 16.0 (Chicago, IL, USA) was used for all data analysis. When the data were found to be normally distributed,the RMANOVA were used to assess ...

  12. Evaluating the Flipped Classroom: A Randomized Controlled Trial

    Science.gov (United States)

    Wozny, Nathan; Balser, Cary; Ives, Drew

    2018-01-01

    Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

  13. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  14. Asthma Self-Management Model: Randomized Controlled Trial

    Science.gov (United States)

    Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo

    2016-01-01

    Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…

  15. The assessment of field trials in GMO research around the world and their possible integration in field trials for variety registration

    NARCIS (Netherlands)

    Slot, M.M.; Wiel, van de C.C.M.; Kleter, G.A.; Visser, R.G.F.; Kok, E.J.

    2018-01-01

    Most regulations worldwide stipulate that a new genetically modified (GM) crop event has to be compared to its closest non-GM counterpart as a corner stone of the pre-market risk assessment. To this end the GM crop and its comparator should be grown in field trials for a phenotypic comparison as

  16. Treatment of knee osteoarthritis with pulsed electromagnetic fields: a randomized, double-blind, placebo-controlled study

    DEFF Research Database (Denmark)

    Thamsborg, G; Florescu, A; Oturai, P

    2005-01-01

    OBJECTIVE: The investigation aimed at determining the effectiveness of pulsed electromagnetic fields (PEMF) in the treatment of osteoarthritis (OA) of the knee by conducting a randomized, double-blind, placebo-controlled clinical trial. DESIGN: The trial consisted of 2h daily treatment 5 days per...

  17. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

    Science.gov (United States)

    2014-09-26

    SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

  18. CArbon dioxide surgical field flooding and aortic NO-touch off-pump coronary artery bypass grafting to reduce Neurological injuries after surgical coronary revascularisation (CANON): protocol for a randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms

    Science.gov (United States)

    Szwed, Krzysztof; Pawliszak, Wojciech; Serafin, Zbigniew; Kowalewski, Mariusz; Tomczyk, Remigiusz; Perlinski, Damian; Szwed, Magdalena; Tomaszewska, Marta; Anisimowicz, Lech; Borkowska, Alina

    2017-01-01

    Introduction Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offsets survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue is the development of off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved neurological outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques. Methods and analysis In this randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms, a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment arms and one control arm. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG with partial clamp. The primary endpoint will be the appearance of new lesions on control brain MRI 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis. Ethics and dissemination Ethical approval has been granted for this study. Results will be disseminated through peer-reviewed media. Trial registration number NCT03074604; Pre-results. Date and version identifier 10-Mar-2017 Original PMID:28698347

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

    International Nuclear Information System (INIS)

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

    2011-01-01

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

  20. A deworming field trial with ivermectin (MSD in reindeer

    Directory of Open Access Journals (Sweden)

    M. Nordkvist

    1984-05-01

    Full Text Available This paper is to be regarded as a follow-up under field conditions of Nordkvist et al. (1983 as far as ivermectin is concerned. 54 reindeer calves (29 males + 25 females, as far as possible of normal size, were selected November 15th, 1982 from a reindeer herd belonging to Maskaure sameby, Arvidsjaur. The calves were individually branded, by means of ear tags and weighed. 29 calves (15 males + 14 females were treated with ivermectin (Ivomec 1% MSD at a dose rate of 1 ml per calf (roughly corresponding to 200 meg ivermectin per kg body weight, subcutaneous injection. Remaining 25 calves (14 males + 11 females served as untreated controls. The entire group of calves was then returned to the herd for free grazing during winter. During the winter 3 treated calves were found dead, all three of them had been suffering from keratoconjunctivitis. If any of the control animals had succumbed during the same time is not known. On April 21st, 1983 (approx. 150 days post treatment 44 calves (24 treated + 20 controls were weighed. 5 treated and 5 controls were randomly selected for slaughter. Carcasses and organs were thoroughly examined from a parasitological and, as far as lungs were concerned, pathological point of view. The efficacy of the treatment was 100(M> or nearly 100% against Oedemagena tarandi, Cephenemyia trompe, Dictyocaulus viviparus, Elaphostrongylus rangiferi, and nematode eggs in faeces. The efficacy against gastrointestinal nematodes was, probably due to date of treatment, somewhat difficult to judge (Tab 1. A statistical analysis of the weight changes, relative to initial weights, (Tab. 2 supports the statements — that all animals had lost weight — that treated males had lost significantly less of their body weights than control males — That weight change of treated females did not differ significantly from that of control females — that the average weight loss of the entire treated group was significantly less than that of the

  1. The Sentry Autonomous Underwater Vehicle: Field Trial Results and Future Capabilities

    Science.gov (United States)

    Yoerger, D. R.; Bradley, A. M.; Martin, S. C.; Whitcomb, L. L.

    2006-12-01

    The Sentry autonomous underwater vehicle combines an efficient long range survey capability with the ability to maneuver at low speeds. These attributes will permit Sentry to perform a variety of conventional and unconventional surveys including long range sonar surveys, hydrothermal plume surveys and near-bottom photo surveys. Sentry's streamlined body and fore and aft tilting planes, each possessing an independently controlled thruster, enable efficient operation in both near-bottom and cruising operations. Sentry is capable of being configured in two modes: hover mode, which commands Sentry's control surfaces to be aligned vertically, and forward flight mode, which allows Sentry's control surfaces to actuate between plus or minus 45 degrees. Sentry is equipped for full 6-Degrees of freedom position measurement. Vehicle heading, roll, and pitch are instrumented with a TCM2 PNI heading and attitude sensor. A Systron Donner yaw rate sensor instrumented heading rate. Depth is instrumented by a Paroscientific depth sensor. A 300kHz RD Instruments Doppler Sonar provides altitude and XYZ velocity measurements. In April 2006, we conducted our first deep water field trials of Sentry in Bermuda. These trials enabled us to examine a variety of issues, including the control software, vehicle safety systems, launch and recovery procedures, operation at depth, heading and depth controllers over a range of speeds, and power consumption. Sentry employ's a control system based upon the Jason 2 control system for low-level control, which has proven effective and reliable over several hundred deep-water dives. The Jason 2 control system, developed jointly at Johns Hopkins University and Woods Hole Oceanographic Institution, was augmented to manage Sentry-specific devices (sensors, actuators, and power storage) and to employ a high-level mission controller that supported autonomous mission scripting and error detection and response. This control suite will also support the Nereus

  2. Qigong and Fibromyalgia: Randomized Controlled Trials and Beyond

    Directory of Open Access Journals (Sweden)

    Jana Sawynok

    2014-01-01

    Full Text Available Introduction. Qigong is currently considered as meditative movement, mindful exercise, or complementary exercise and is being explored for relief of symptoms in fibromyalgia. Aim. This narrative review summarizes randomized controlled trials, as well as additional studies, of qigong published to the end of 2013 and discusses relevant methodological issues. Results. Controlled trials indicate regular qigong practice (daily, 6–8 weeks produces improvements in core domains for fibromyalgia (pain, sleep, impact, and physical and mental function that are maintained at 4–6 months compared to wait-list subjects or baselines. Comparisons with active controls show little difference, but compared to baseline there are significant and comparable effects in both groups. Open-label studies provide information that supports benefit but remain exploratory. An extension trial and case studies involving extended practice (daily, 6–12 months indicate marked benefits but are limited by the number of participants. Benefit appears to be related to amount of practice. Conclusions. There is considerable potential for qigong to be a useful complementary practice for the management of fibromyalgia. However, there are unique methodological challenges, and exploration of its clinical potential will need to focus on pragmatic issues and consider a spectrum of trial designs. Mechanistic considerations need to consider both system-wide and more specific effects.

  3. U.S. laboratory and field trials of metofluthrin (SumiOne) emanators for reducing mosquito biting outdoors.

    Science.gov (United States)

    Lucas, J R; Shono, Y; Iwasaki, T; Ishiwatari, T; Spero, N; Benzon, G

    2007-03-01

    Metofluthrin (SumiOne is a novel, vapor-active pyrethroid that is highly effective against mosquitoes. Laboratory and field trials were conducted in the United States to evaluate the mosquito repellent activity of metofluthrin-treated paper substrates ("emanators"). Initial studies were conducted to evaluate the field performance of 900-cm(2) paper fan emanators impregnated with 160 mg metofluthrin, where Aedes canadensis was the predominant species. Emanators reduced landing rates on human volunteers by between 85% and 100% compared to untreated controls. Subsequent tests with 4,000-cm(2) paper strip emanators impregnated with 200 mg metofluthrin were conducted in a wind tunnel as a precursor to conducting field trials using human bait and laboratory-reared Aedes aegypti. Paper strips, which were pre-aged in a fume hood to determine duration of protection, gave 89-91% reductions in landing rates compared with controls. Similar reductions in biting activity were also noted. Following these tests, field trials to assess effect on landing rates were conducted with emanators positioned 1.22 m on either side of volunteers protected from biting by Tyvek suits, with pre- and posttreatment counts being made. In Florida (predominantly Ochlerotatus spp.) 91-95% reductions were noted 10-30 min after emanators were deployed, while in Washington State (mostly Aedes vexans) 95-97% reductions were observed. These results demonstrate that metofluthrin-treated emanators are highly effective at repelling mosquitoes.

  4. Research on single-chip microcomputer controlled rotating magnetic field mineralization model

    Science.gov (United States)

    Li, Yang; Qi, Yulin; Yang, Junxiao; Li, Na

    2017-08-01

    As one of the method of selecting ore, the magnetic separation method has the advantages of stable operation, simple process flow, high beneficiation efficiency and no chemical environment pollution. But the existing magnetic separator are more mechanical, the operation is not flexible, and can not change the magnetic field parameters according to the precision of the ore needed. Based on the existing magnetic separator is mechanical, the rotating magnetic field can be used for single chip microcomputer control as the research object, design and trial a rotating magnetic field processing prototype, and through the single-chip PWM pulse output to control the rotation of the magnetic field strength and rotating magnetic field speed. This method of using pure software to generate PWM pulse to control rotary magnetic field beneficiation, with higher flexibility, accuracy and lower cost, can give full play to the performance of single-chip.

  5. Control of the radial electric field shear by modification of the magnetic field configuration in LHD

    International Nuclear Information System (INIS)

    Ida, K.; Yoshinuma, M.; Yokoyama, M.

    2005-01-01

    Control of the radial electric field, E γ , is considered to be important in helical plasmas, because the radial electric field and its shear are expected to reduce neoclassical and anomalous transport, respectively. In general, the radial electric field can be controlled by changing the collisionality, and positive or negative electric field have been obtained by decreasing or increasing the electron density, respectively. Although the sign of the radial electric field can be controlled by changing the collisionality, modification of the magnetic field is required to achieve further control of the radial electric field, especially producing a strong radial electric field shear. In the Large Helical Device (LHD) the radial electric field profiles are shown to be controlled by the modification of the magnetic field by 1) changing the radial profile of the helical ripples, ε h , 2) creating a magnetic island with an external perturbation field coil and 3) changing the local island divertor coil current. (author)

  6. Control of the radial electric field shear by modification of the magnetic field configuration in LHD

    International Nuclear Information System (INIS)

    Ida, K.; Yoshinuma, M.; Yokoyama, M.

    2005-01-01

    Control of the radial electric field, E r , is considered to be important in helical plasmas, because the radial electric field and its shear are expected to reduce neoclassical and anomalous transport, respectively. In general, the radial electric field can be controlled by changing the collisionality, and positive or negative electric fields have been obtained by decreasing or increasing the electron density, respectively. Although the sign of the radial electric field can be controlled by changing the collisionality, modification of the magnetic field is required to achieve further control of the radial electric field, especially to produce a strong radial electric field shear. In the Large Helical Device (LHD) the radial electric field profiles are shown to be controlled by the modification of the magnetic field by (1) changing the radial profile of the effective helical ripples, ε h (2) creating a magnetic island with an external perturbation field coil and (3) changing the local island divertor coil current

  7. Estimating the Magnitude and Field-Size Dependence of Radiotherapy-Induced Mortality and Tumor Control After Postoperative Radiotherapy For Non-Small-Cell Lung Cancer: Calculations From Clinical Trials

    International Nuclear Information System (INIS)

    Miles, Edward F.; Kelsey, Chris R.; Kirkpatrick, John P.; Marks, Lawrence B.

    2007-01-01

    Purpose: To create, on the basis of available data, a mathematical model to describe the tumor stage- and field size-dependent risks/benefits of postoperative radiotherapy (PORT) for non-small-cell lung cancer (NSCLC), and to assess whether this simple model can accurately describe the reported changes in overall survival. Methods and Materials: The increase in overall survival afforded by PORT is assumed equal to the increase in cancer-specific survival minus the rate of RT-induced mortality. The increase in cancer-specific survival is the product of the probabilities of (residual local disease) x (sterilization of residual disease with PORT) x (absence of metastatic disease). Data were extracted from the literature to estimate these probabilities. Different models were considered to relate the RT-induced mortality to field size. Results: The rate of RT-induced mortality seems to be proportional to the cube of the field size. When these mortality rates are included in the model, the predicted changes in overall survival approximate the literature values. Conclusion: Clinical data can be explained by a simple model that suggests that RT-induced mortality is strongly dependent on field size and at least partly offsets the benefit afforded by PORT. Smaller RT fields, tailored to treat the areas most at risk for recurrence, provide the highest therapeutic ratio. The data used do not reflect the impact of chemotherapy, which will reduce the rate of distant metastases and enhance the efficacy of RT

  8. The assessment of field trials in GMO research around the world and their possible integration in field trials for variety registration.

    Science.gov (United States)

    Slot, M M; van de Wiel, C C M; Kleter, G A; Visser, R G F; Kok, E J

    2018-05-04

    Most regulations worldwide stipulate that a new genetically modified (GM) crop event has to be compared to its closest non-GM counterpart as a corner stone of the pre-market risk assessment. To this end the GM crop and its comparator should be grown in field trials for a phenotypic comparison as well as for subsequent detailed analysis of the composition of the two crop varieties. A more in-depth globally harmonised approach for the conduct of these field trials is lacking. Only a few countries have formulated detailed protocols for the set-up of GM field trials. In some countries, commercial non-GM reference varieties need to be included in a field study to compile reliable data that indicate the range of natural variation for the compounds tested at the specific location. Detailed analysis of pre-market assessment reports have so far not shown the added value of including these reference varieties in the field trials. In all cases where specific values were found to be outside of the range of the reference varieties, it proved possible to draw conclusions on the part of the pre-market risk assessment that relates to the compositional analysis, on the basis of already available compositional data. With the increasing quality of several databases on compositional data of a growing number of crop species, it seems unlikely that reference varieties will become more important on future occasions. It was furthermore investigated whether this part of the risk assessment can be related to field trial requirements for variety registration with the explicit intention of reducing the data burden on producers of new GM plant varieties. Field trials for variety registration so far include an assessment of phenotypic characteristics that do not cover safety aspects, with the exception of establishment of the glycoalkaloid content in potatoes in the Netherlands and Sweden. It may, however, under certain conditions be relatively easy to exchange data from compositional

  9. Meteorology and lidar data from the URAHFREP field trials

    DEFF Research Database (Denmark)

    Ott, Søren; Ejsing Jørgensen, Hans

    2002-01-01

    to the HF release. The instrumentation included various types of HF sensors, thermocouple arrays, a fully instrumented release rig, a passive smokemachine, a meteorological mast and a lidar backscatter system. This report deals exclusively with the meteorological data and the lidar data. The trials cover...... a range meteorological conditions. These include neutral conditions with relatively highwindspeed and low humidity as well as unstable conditions with low windspeed and high humidity, the most favorable conditions for lift-off to occur. The lidar was used to scan vertical cross-plume slices 100 meter...

  10. Community-led trials: Intervention co-design in a cluster randomised controlled trial.

    Science.gov (United States)

    Andersson, Neil

    2017-05-30

    In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control.Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies.A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a "male competence".Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the conventional wisdom about how

  11. Community-led trials: Intervention co-design in a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Neil Andersson

    2017-05-01

    Full Text Available Abstract In conventional randomised controlled trials (RCTs, researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control. Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies. A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a “male competence”. Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the

  12. Moxibustion for cephalic version: a feasibility randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Bisits Andrew

    2011-09-01

    Full Text Available Abstract Background Moxibustion (a type of Chinese medicine which involves burning a herb close to the skin has been used to correct a breech presentation. Evidence of effectiveness and safety from systematic reviews is encouraging although significant heterogeneity has been found among trials. We assessed the feasibility of conducting a randomised controlled trial of moxibustion plus usual care compared with usual care to promote cephalic version in women with a breech presentation, and examined the views of women and health care providers towards implementing a trial within an Australian context. Methods The study was undertaken at a public hospital in Newcastle, New South Wales, Australia. Women at 34-36.5 weeks of gestation with a singleton breech presentation (confirmed by ultrasound, were randomised to moxibustion plus usual care or usual care alone. The intervention was administered over 10 days. Clinical outcomes included cephalic presentation at birth, the need for ECV, mode of birth; perinatal morbidity and mortality, and maternal complications. Feasibility outcomes included: recruitment rate, acceptability, compliance and a sample size for a future study. Interviews were conducted with 19 midwives and obstetricians to examine the acceptability of moxibustion, and views on the trial. Results Twenty women were randomised to the trial. Fifty one percent of women approached accepted randomisation to the trial. A trend towards an increase in cephalic version at delivery (RR 5.0; 95% CI 0.7-35.5 was found for women receiving moxibustion compared with usual care. There was also a trend towards greater success with version following ECV. Two babies were admitted to the neonatal unit from the moxibustion group. Compliance with the moxibustion protocol was acceptable with no reported side effects. Clinicians expressed the need for research to establish the safety and efficacy of moxibustion, and support for the intervention was given to

  13. Evaluating the importance of sham controlled trials in the investigation of medical devices in interventional cardiology.

    Science.gov (United States)

    Byrne, Robert A; Capodanno, Davide; Mahfoud, Felix; Fajadet, Jean; Windecker, Stephan; Jüni, Peter; Baumbach, Andreas; Wijns, William; Haude, Michael

    2018-05-22

    Cardiovascular medicine is one of the specialties that has relied most heavily on evidence from randomized clinical trials in determining best practice for the management of common disease conditions. When comparing treatment approaches, trials incorporating random allocation are the most appropriate method for protecting against treatment allocation bias. In order to protect against performance and ascertainment bias, trial designs including placebo control are preferable where feasible. In contrast to testing of medicines, treatments based on procedures or use of medical devices are more challenging to assess, as sham procedures are necessary to facilitate blinding of participants. However, in many cases, ethical concerns exist, as individual patients allocated to sham procedure are exposed only to risk without potential for benefit. Accordingly, the potential benefits to the general patient population must be carefully weighed against the risks of the exposed individuals. For this reason, trial design and study conduct are critically important to ensure that the investigation has the best chance of answering the study question at hand. In the current manuscript, we aim to review issues relating to the conduct of sham-controlled trials and discuss a number of recent examples in the field of interventional cardiology.

  14. A randomized, controlled trial of oral propranolol in infantile hemangioma.

    Science.gov (United States)

    Léauté-Labrèze, Christine; Hoeger, Peter; Mazereeuw-Hautier, Juliette; Guibaud, Laurent; Baselga, Eulalia; Posiunas, Gintas; Phillips, Roderic J; Caceres, Hector; Lopez Gutierrez, Juan Carlos; Ballona, Rosalia; Friedlander, Sheila Fallon; Powell, Julie; Perek, Danuta; Metz, Brandie; Barbarot, Sebastien; Maruani, Annabel; Szalai, Zsuzsanna Zsofia; Krol, Alfons; Boccara, Olivia; Foelster-Holst, Regina; Febrer Bosch, Maria Isabel; Su, John; Buckova, Hana; Torrelo, Antonio; Cambazard, Frederic; Grantzow, Rainer; Wargon, Orli; Wyrzykowski, Dariusz; Roessler, Jochen; Bernabeu-Wittel, Jose; Valencia, Adriana M; Przewratil, Przemyslaw; Glick, Sharon; Pope, Elena; Birchall, Nicholas; Benjamin, Latanya; Mancini, Anthony J; Vabres, Pierre; Souteyrand, Pierre; Frieden, Ilona J; Berul, Charles I; Mehta, Cyrus R; Prey, Sorilla; Boralevi, Franck; Morgan, Caroline C; Heritier, Stephane; Delarue, Alain; Voisard, Jean-Jacques

    2015-02-19

    Oral propranolol has been used to treat complicated infantile hemangiomas, although data from randomized, controlled trials to inform its use are limited. We performed a multicenter, randomized, double-blind, adaptive, phase 2-3 trial assessing the efficacy and safety of a pediatric-specific oral propranolol solution in infants 1 to 5 months of age with proliferating infantile hemangioma requiring systemic therapy. Infants were randomly assigned to receive placebo or one of four propranolol regimens (1 or 3 mg of propranolol base per kilogram of body weight per day for 3 or 6 months). A preplanned interim analysis was conducted to identify the regimen to study for the final efficacy analysis. The primary end point was success (complete or nearly complete resolution of the target hemangioma) or failure of trial treatment at week 24, as assessed by independent, centralized, blinded evaluations of standardized photographs. Of 460 infants who underwent randomization, 456 received treatment. On the basis of an interim analysis of the first 188 patients who completed 24 weeks of trial treatment, the regimen of 3 mg of propranolol per kilogram per day for 6 months was selected for the final efficacy analysis. The frequency of successful treatment was higher with this regimen than with placebo (60% vs. 4%, P<0.001). A total of 88% of patients who received the selected propranolol regimen showed improvement by week 5, versus 5% of patients who received placebo. A total of 10% of patients in whom treatment with propranolol was successful required systemic retreatment during follow-up. Known adverse events associated with propranolol (hypoglycemia, hypotension, bradycardia, and bronchospasm) occurred infrequently, with no significant difference in frequency between the placebo group and the groups receiving propranolol. This trial showed that propranolol was effective at a dose of 3 mg per kilogram per day for 6 months in the treatment of infantile hemangioma. (Funded by

  15. Reported challenges in nurse-led randomised controlled trials

    DEFF Research Database (Denmark)

    Wang Vedelø, Tina; Lomborg, Kirsten

    2011-01-01

    Aims: The purpose of this integrative literature review was to explore and discuss the methodological challenges nurse researchers report after conducting nurse-led randomised controlled trials in clinical hospital settings. Our research questions were (i) what are the most commonly experienced...... and the clinical nursing staff. Two lessons learned from this integrative review can be highlighted. First, we recommend researchers openly to share their experiences of barriers and challenges. They should describe factors that may have inhibited the desired outcome. Second, efforts to improve the collaboration...... between nurse researchers and clinicians, including education, training and support may increase the success rate and quality of nurse-led studies using the randomised controlled trial....

  16. Field-measured drag area is a key correlate of level cycling time trial performance

    Directory of Open Access Journals (Sweden)

    James E. Peterman

    2015-08-01

    Full Text Available Drag area (Ad is a primary factor determining aerodynamic resistance during level cycling and is therefore a key determinant of level time trial performance. However, Ad has traditionally been difficult to measure. Our purpose was to determine the value of adding field-measured Ad as a correlate of level cycling time trial performance. In the field, 19 male cyclists performed a level (22.1 km time trial. Separately, field-determined Ad and rolling resistance were calculated for subjects along with projected frontal area assessed directly (AP and indirectly (Est AP. Also, a graded exercise test was performed to determine $\\dot {V}{O}_{2}$V̇O2 peak, lactate threshold (LT, and economy. $\\dot {V}{O}_{2}$V̇O2 peak ($\\mathrm{l}~\\min ^{-1}$lmin−1 and power at LT were significantly correlated to power measured during the time trial (r = 0.83 and 0.69, respectively but were not significantly correlated to performance time (r = − 0.42 and −0.45. The correlation with performance time improved significantly (p < 0.05 when these variables were normalized to Ad. Of note, Ad alone was better correlated to performance time (r = 0.85, p < 0.001 than any combination of non-normalized physiological measure. The best correlate with performance time was field-measured power output during the time trial normalized to Ad (r = − 0.92. AP only accounted for 54% of the variability in Ad. Accordingly, the correlation to performance time was significantly lower using power normalized to AP (r = − 0.75 or Est AP (r = − 0.71. In conclusion, unless normalized to Ad, level time trial performance in the field was not highly correlated to common laboratory measures. Furthermore, our field-measured Ad is easy to determine and was the single best predictor of level time trial performance.

  17. Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial.

    OpenAIRE

    Jones, D. A.; West, R. R.

    1996-01-01

    OBJECTIVE: To evaluate rehabilitation after myocardial infarction. DESIGN: Randomised controlled trial of rehabilitation in unselected myocardial infarction patients in six centres, baseline data being collected on admission and by structured interview (of patients and spouses) shortly after discharge and outcome being assessed by structured interview at six months and clinical examination at 12 months. SETTING: Six district general hospitals. SUBJECTS: All 2328 eligible patients admitted ove...

  18. Neighborhood Effects in a Behavioral Randomized Controlled Trial

    OpenAIRE

    Pruitt, Sandi L.; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

    2014-01-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5,628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient’s CRC test use. This potentially import...

  19. Establishing vegetation on Kimberlite mine tailings: 2. Field trials. | N ...

    African Journals Online (AJOL)

    A series of field experiments were carried out on Kimberlite mine tailing located at Cullinan in the Transvaal. The most successful species in pure sward were Chloris gayana, Cynodon aethiopicus, Eragrostis curvula, E. tef, Pennisetum purpureum, Melilotus alban and Medicago sativa. Growth of grasses in the absence of ...

  20. Outcomes in registered, ongoing randomized controlled trials of patient education.

    Directory of Open Access Journals (Sweden)

    Cécile Pino

    Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

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

    Directory of Open Access Journals (Sweden)

    Craig Fiona F

    2012-04-01

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

  2. Simulated Field Trials Using an Indoor Aerosol Test Chamber

    National Research Council Canada - National Science Library

    Semler, D. D; Roth, A. P; Semler, K. A; Nolan, P. M

    2004-01-01

    .... In this method, the aerosol chamber control software manipulates circulation fan speeds, chamber vacuum and agent spray times to produce a simulated dynamic cloud within the aerosol test chamber...

  3. Simulated Field Trials Using An Indoor Aerosol Test Chamber

    National Research Council Canada - National Science Library

    Semler, D. D; Roth, A. P; Semler, K. A; Nolan, P. M

    2004-01-01

    .... In this method, the aerosol chamber control software manipulates circulation fan speeds, chamber vacuum and agent spray times to produce a simulated dynamic cloud within the aerosol test chamber...

  4. Should desperate volunteers be included in randomised controlled trials?

    Science.gov (United States)

    Allmark, P; Mason, S

    2006-09-01

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

  5. SUPERFUND TREATABILITY CLEARINGHOUSE: FULL SCALE ROTARY KILN INCINERATOR FIELD TRIAL: PHASE I, VERIFICATION TRIAL BURN ON DIOXIN/HERBICIDE ORANGE CONTAMINATED SOIL

    Science.gov (United States)

    This treatability study reports on the results of one of a series of field trials using various remedial action technologies that may be capable of restoring Herbicide Orange (HO)XDioxin contaminated sites. A full-scale field trial using a rotary kiln incinerator capable of pro...

  6. Teenage pregnancy and social disadvantage: systematic review integrating controlled trials and qualitative studies.

    Science.gov (United States)

    Harden, Angela; Brunton, Ginny; Fletcher, Adam; Oakley, Ann

    2009-11-12

    To determine the impact on teenage pregnancy of interventions that address the social disadvantage associated with early parenthood and to assess the appropriateness of such interventions for young people in the United Kingdom. Systematic review, including a statistical meta-analysis of controlled trials on interventions for early parenthood and a thematic synthesis of qualitative studies that investigated the views on early parenthood of young people living in the UK. 12 electronic bibliographic databases, five key journals, reference lists of relevant studies, study authors, and experts in the field. Review methods Two independent reviewers assessed the methodological quality of studies and abstracted data. Ten controlled trials and five qualitative studies were included. Controlled trials evaluated either early childhood interventions or youth development programmes. The overall pooled effect size showed that teenage pregnancy rates were 39% lower among individuals receiving an intervention than in those receiving standard practice or no intervention (relative risk 0.61; 95% confidence interval 0.48 to 0.77). Three main themes associated with early parenthood emerged from the qualitative studies: dislike of school; poor material circumstances and unhappy childhood; and low expectations for the future. Comparison of these factors related to teenage pregnancy with the content of the programmes used in the controlled trials indicated that both early childhood interventions and youth development programmes are appropriate strategies for reducing unintended teenage pregnancies. The programmes aim to promote engagement with school through learning support, ameliorate unhappy childhood through guidance and social support, and raise aspirations through career development and work experience. However, none of these approaches directly tackles all the societal, community, and family level factors that influence young people's routes to early parenthood. A small but

  7. A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial.

    Science.gov (United States)

    Langhorne, Peter; Wu, Olivia; Rodgers, Helen; Ashburn, Ann; Bernhardt, Julie

    2017-09-01

    Mobilising patients early after stroke [early mobilisation (EM)] is thought to contribute to the beneficial effects of stroke unit care but it is poorly defined and lacks direct evidence of benefit. We assessed the effectiveness of frequent higher dose very early mobilisation (VEM) after stroke. We conducted a parallel-group, single-blind, prospective randomised controlled trial with blinded end-point assessment using a web-based computer-generated stratified randomisation. The trial took place in 56 acute stroke units in five countries. We included adult patients with a first or recurrent stroke who met physiological inclusion criteria. Patients received either usual stroke unit care (UC) or UC plus VEM commencing within 24 hours of stroke. The primary outcome was good recovery [modified Rankin scale (mRS) score of 0-2] 3 months after stroke. Secondary outcomes at 3 months were the mRS, time to achieve walking 50 m, serious adverse events, quality of life (QoL) and costs at 12 months. Tertiary outcomes included a dose-response analysis. Patients, outcome assessors and investigators involved in the trial were blinded to treatment allocation. We recruited 2104 (UK, n  = 610; Australasia, n  = 1494) patients: 1054 allocated to VEM and 1050 to UC. Intervention protocol targets were achieved. Compared with UC, VEM patients mobilised 4.8 hours [95% confidence interval (CI) 4.1 to 5.7 hours; p  pattern of an improved odds of efficacy and safety outcomes in association with increased daily frequency of out-of-bed sessions but a reduced odds with an increased amount of mobilisation (minutes per day). UC clinicians started mobilisation earlier each year altering the context of the trial. Other potential confounding factors included staff patient interaction. Patients in the VEM group were mobilised earlier and with a higher dose of therapy than those in the UC group, which was already early. This VEM protocol was associated with reduced odds of favourable

  8. Mississippi exploration field trials using microbial, radiometrics, free soil gas, and other techniques

    Energy Technology Data Exchange (ETDEWEB)

    Moody, J.S.; Brown, L.R.; Thieling, S.C.

    1995-12-31

    The Mississippi Office of Geology has conducted field trials using the surface exploration techniques of geomicrobial, radiometrics, and free soil gas. The objective of these trials is to determine if Mississippi oil and gas fields have surface hydrocarbon expression resulting from vertical microseepage migration. Six fields have been surveyed ranging in depth from 3,330 ft to 18,500 ft. The fields differ in trapping styles and hydrocarbon type. The results so far indicate that these fields do have a surface expression and that geomicrobial analysis as well as radiometrics and free soil gas can detect hydrocarbon microseepage from pressurized reservoirs. All three exploration techniques located the reservoirs independent of depth, hydrocarbon type, or trapping style.

  9. A deworming field trial with ivermectin (MSD) in reindeer

    OpenAIRE

    Nordkvist, M.; Christensson, D.; Rehbinder, C.

    1984-01-01

    This paper is to be regarded as a follow-up under field conditions of Nordkvist et al. (1983) as far as ivermectin is concerned. 54 reindeer calves (29 males + 25 females), as far as possible of normal size, were selected November 15th, 1982 from a reindeer herd belonging to Maskaure sameby, Arvidsjaur. The calves were individually branded, by means of ear tags and weighed. 29 calves (15 males + 14 females) were treated with ivermectin (Ivomec 1% MSD) at a dose rate of 1 ml per calf (roughly ...

  10. Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Foglia, Elizabeth E; Owen, Louise S; Thio, Marta; Ratcliffe, Sarah J; Lista, Gianluca; Te Pas, Arjan; Hummler, Helmut; Nadkarni, Vinay; Ades, Anne; Posencheg, Michael; Keszler, Martin; Davis, Peter; Kirpalani, Haresh

    2015-03-15

    Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question. This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

  11. Review of Randomized Controlled Trials of Massage in Preterm Infants

    Directory of Open Access Journals (Sweden)

    Anna-Kaisa Niemi

    2017-04-01

    Full Text Available Preterm birth affects about 10% of infants born in the United States. Massage therapy is being used in some neonatal intensive care units for its potential beneficial effects on preterm infants. This article reviews published randomized controlled trials on the effects of massage in preterm infants. Most studies evaluating the effect of massage in weight gain in premature infants suggest a positive effect on weight gain. Increase in vagal tone has been reported in infants who receive massage and has been suggested as a possible mechanism for improved weight gain. More studies are needed on the underlying mechanisms of the effects of massage therapy on weight gain in preterm infants. While some trials suggest improvements in developmental scores, decreased stress behavior, positive effects on immune system, improved pain tolerance and earlier discharge from the hospital, the number of such studies is small and further evidence is needed. Further studies, including randomized controlled trials, are needed on the effects of massage in preterm infants.

  12. A randomised controlled trial of complete denture impression materials.

    Science.gov (United States)

    Hyde, T P; Craddock, H L; Gray, J C; Pavitt, S H; Hulme, C; Godfrey, M; Fernandez, C; Navarro-Coy, N; Dillon, S; Wright, J; Brown, S; Dukanovic, G; Brunton, P A

    2014-08-01

    There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, pUnilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. Difficulties in recruitment for a randomized controlled trial involving hysterosalpingography

    Directory of Open Access Journals (Sweden)

    Helmerhorst Frans M

    2006-06-01

    Full Text Available Abstract Background The usefulness of hysterosalpingography (HSG as routine investigation in the fertility work-up prior to laparoscopy and dye had been assessed in a randomized controlled trial. Recruiting subjects to the study was more difficult than anticipated. The objective of this study was to explore possible reasons for non-participation in the trial. Methods All newly referred subfertile women admitted to the Reproductive Medicine Clinic of Leiden University Medical Centre between 1 April 1997 and 31 December 1999, were eligible for the study. The reasons for non-participation were evaluated by scrutinizing the medical records. Results Out of 759 women, a total of 127 (17% agreed to participate in the trial. The most important reason for non-participation was because of exclusion criteria (73%. Other reasons were inattentive clinicians (3% and patient-associated reasons (24%. Patient refusal and indecisiveness to enroll in the study were the most common patient-associated reasons. The most frequently stated reason for trial refusal was reluctance to undergo laparoscopy and dye mainly due to issues related to anesthesia and scheduling of procedure. Conclusion Almost three-quarters of recruitment difficulties in this study were due to unavoidable reasons. To overcome the remaining avoidable reasons for non-participation, attention should be paid to appropriate instruction of the study protocol to the participating doctors and to provide adequate information, in layman's terms, to the patients. Reminding patients by notes or telephone calls for attending the clinic are helpful. It may be contingent upon tracing the reasons of clinicians and patients for non-participation to improve enrollment during a trial.

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

    Science.gov (United States)

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

    2012-04-28

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

  15. Field-scale multi-phase LNAPL remediation: Validating a new computational framework against sequential field pilot trials.

    Science.gov (United States)

    Sookhak Lari, Kaveh; Johnston, Colin D; Rayner, John L; Davis, Greg B

    2018-03-05

    Remediation of subsurface systems, including groundwater, soil and soil gas, contaminated with light non-aqueous phase liquids (LNAPLs) is challenging. Field-scale pilot trials of multi-phase remediation were undertaken at a site to determine the effectiveness of recovery options. Sequential LNAPL skimming and vacuum-enhanced skimming, with and without water table drawdown were trialled over 78days; in total extracting over 5m 3 of LNAPL. For the first time, a multi-component simulation framework (including the multi-phase multi-component code TMVOC-MP and processing codes) was developed and applied to simulate the broad range of multi-phase remediation and recovery methods used in the field trials. This framework was validated against the sequential pilot trials by comparing predicted and measured LNAPL mass removal rates and compositional changes. The framework was tested on both a Cray supercomputer and a cluster. Simulations mimicked trends in LNAPL recovery rates (from 0.14 to 3mL/s) across all remediation techniques each operating over periods of 4-14days over the 78day trial. The code also approximated order of magnitude compositional changes of hazardous chemical concentrations in extracted gas during vacuum-enhanced recovery. The verified framework enables longer term prediction of the effectiveness of remediation approaches allowing better determination of remediation endpoints and long-term risks. Copyright © 2017 Commonwealth Scientific and Industrial Research Organisation. Published by Elsevier B.V. All rights reserved.

  16. Quality control of radiation therapy in clinical trials

    International Nuclear Information System (INIS)

    Kramer, S.; Lustig, R.; Grundy, G.

    1983-01-01

    The RTOG is a group of participating institutions which has a major interest in furthering clinical radiation oncology. They have formulated protocols for clinical investigation in which radiation therapy is the major modality of treatment. In addition, other modalities, such as chemotherapy, radiation sensitizers, and hyperthermia, are used in combined approach to cancer. Quality control in all aspects of patient management is necessary to insure quality data. These areas include evaluation of pathology, physics, and dosimetry, and clinical patient data. Quality control is both time consuming and expensive. However, by dividing these tasks into various levels and time frames, by using computerized data-control mechanisms, and by employing appropriate levels of ancillary personnel expertise, quality control can improve compliance and decrease the cost of investigational trials

  17. Mapping Field Trials II Mendocino Volcano Field I and II (EX0905, EM302) on NOAA Ship Okeanos Explorer in North Pacific Ocean

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The goals of this field trial cruise are to test use of EX mapping sensors to characterize complex geological areas (i.e. volcanic field) and develop protocols to...

  18. A randomized controlled Alzheimer's disease prevention trial's evolution into an exposure trial: the PREADViSE Trial.

    Science.gov (United States)

    Kryscio, R J; Abner, E L; Schmitt, F A; Goodman, P J; Mendiondo, M; Caban-Holt, A; Dennis, B C; Mathews, M; Klein, E A; Crowley, J J

    2013-01-01

    To summarize the ongoing prevention of Alzheimer's disease (AD) by vitamin E and selenium (PREADViSE) trial as an ancillary study to SELECT (a large prostate cancer prevention trial) and to present the blinded results of the first year as an exposure study. PREADViSE was designed as a double blind randomized controlled trial (RCT). SELECT terminated after median of 5.5 years of exposure to supplements due to a futility analysis. Both trials then converted into an exposure study. In the randomized component PREADViSE enrolled 7,547 men age 62 or older (60 if African American). Once the trial terminated 4,246 of these men volunteered for the exposure study. Demographics were similar for both groups with exposure volunteers having baseline mean age 67.3 ± 5.2 years, 15.3 ± 2.4 years of education, 9.8% African Americans, and 22.0% reporting a family history of dementia. In the RCT men were randomly assigned to either daily doses of 400 IU of vitamin E or placebo and 200 µg of selenium or placebo using a 2x2 factorial structure. In the RCT, participants completed the memory impairment screen (MIS), and if they failed, underwent a longer screening (based on an expanded Consortium to Establish a Registry in AD [CERAD] battery). CERAD failure resulted in visits to their clinician for medical examination with records of these examinations forwarded to the PREADViSE center for further review. In the exposure study, men are contacted by telephone and complete the telephone version of the memory impairment screen (MIS-T) screen. If they fail the MIS-T, a modified telephone interview of cognitive status (TICS-M) exam is given. A failed TICS-M exam also leads to a visit to their clinician for an in-depth examination and forwarding of records for a centralized consensus diagnosis by expert clinicians. A subgroup of the men who pass the MIS-T also take the TICS-M exam for validation purposes. While this ancillary trial was open to all 427 SELECT clinical sites, only 130 (30

  19. A Randomised Controlled Trial of complete denture impression materials

    Science.gov (United States)

    Hyde, T.P.; Craddock, H.L.; Gray, J.C.; Pavitt, S.H.; Hulme, C.; Godfrey, M.; Fernandez, C.; Navarro-Coy, N.; Dillon, S.; Wright, J.; Brown, S.; Dukanovic, G.; Brunton, P.A.

    2014-01-01

    Objectives There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Methods Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Results Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7–67.3%, p alginate as their material of choice for secondary impressions for complete dentures. Trial Registration: ISRCTN 01528038.

 This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. PMID:24995473

  20. CArbon dioxide surgical field flooding and aortic NO-touch off-pump coronary artery bypass grafting to reduce Neurological injuries after surgical coronary revascularisation (CANON): protocol for a randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms.

    Science.gov (United States)

    Krzysztof, Szwed; Wojciech, Pawliszak; Zbigniew, Serafin; Mariusz, Kowalewski; Remigiusz, Tomczyk; Damian, Perlinski; Magdalena, Szwed; Marta, Tomaszewska; Lech, Anisimowicz; Alina, Borkowska

    2017-07-10

    Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offsets survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue is the development of off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved neurological outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques. In this randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms, a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment arms and one control arm. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG with partial clamp. The primary endpoint will be the appearance of new lesions on control brain MRI 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis. Ethical approval has been granted for this study. Results will be disseminated through peer-reviewed media. NCT03074604; Pre-results. 10-Mar-2017 Original. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  1. Teleradiology (TELEACE) system: results of a field trial

    International Nuclear Information System (INIS)

    Lee, Jong Min; Kim, Gi Bum; Seong, Yeung Soon; Suh, Kyung Jin; Kang, Duk Sik

    1993-01-01

    We report the results of field operation of TELEACE system between Kyung-Pook National University Hospital and Ul-Jin Goon Health Care Medical Center from December, 1990 to September, 1991, which had been operated as a kind of Integrated Services Digital Network projects by KOREA TELECOMMUNICATION Inc. Ul-Jin Goon Health Care Medical Center transmitted 414 plain radiographs to our hospital in speed of 9600BPS. Each image was composed of 1024X1024 pixelsX8 bits/pixel. In our hospital, the image flies were displayed on high resolution monitor (1280X1024 pixels). Text files of image interpretations were transmitted to the health care medical center. The two radiologists who had interpreted the transmitted images, went to the health care medical center and read radiographic films with blind test method. We obtained the following results: false negative rate of 6.3%, false positive rate of 2.4%, mean sensitivity of 81.4%, mean specificity of 96.3%, and mean accuracy of 91.3%. In predictive value of 0.05, there was no significant difference between results of these two types of radiographs. In conclusion, TELEACE system was valuable to the clinicians isolated from services of radiologists

  2. Randomized Controlled Trials in Music Therapy: Guidelines for Design and Implementation.

    Science.gov (United States)

    Bradt, Joke

    2012-01-01

    Evidence from randomized controlled trials (RCTs) plays a powerful role in today's healthcare industry. At the same time, it is important that multiple types of evidence contribute to music therapy's knowledge base and that the dialogue of clinical effectiveness in music therapy is not dominated by the biomedical hierarchical model of evidence-based practice. Whether or not one agrees with the hierarchical model of evidence in the current healthcare climate, RCTs can contribute important knowledge to our field. Therefore, it is important that music therapists are prepared to design trials that meet current methodological standards and, equally important, are able to respond appropriately to those design aspects that may not be feasible in music therapy research. To provide practical guidelines to music therapy researchers for the design and implementation of RCTs as well as to enable music therapists to be well-informed consumers of RCT evidence. This article reviews key design aspects of RCTs and discusses how to best implement these standards in music therapy trials. A systematic presentation of basic randomization methods, allocation concealment strategies, issues related to blinding in music therapy trials and strategies for implementation, the use of treatment manuals, types of control groups, outcome selection, and sample size computation is provided. Despite the challenges of meeting all key design demands typical of an RCT, it is possible to design rigorous music therapy RCTs that accurately estimate music therapy treatment benefits.

  3. Barkhausen noise sensor with direct field control

    Czech Academy of Sciences Publication Activity Database

    Stupakov, Oleksandr

    2013-01-01

    Roč. 11, č. 1 (2013), s. 209-212 ISSN 1546-198X R&D Projects: GA ČR GP102/09/P108 Institutional research plan: CEZ:AV0Z10100520 Keywords : Barkhausen noise * field measurement * magnetic non-destructive testing Subject RIV: JB - Sensor s, Measurment, Regulation Impact factor: 0.558, year: 2013

  4. Digital servo control of random sound fields

    Science.gov (United States)

    Nakich, R. B.

    1973-01-01

    It is necessary to place number of sensors at different positions in sound field to determine actual sound intensities to which test object is subjected. It is possible to determine whether specification is being met adequately or exceeded. Since excitation is of random nature, signals are essentially coherent and it is impossible to obtain true average.

  5. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Scherer, Roberta W; Drye, Lea; Mintzer, Jacobo; Lanctôt, Krista; Rosenberg, Paul; Herrmann, Nathan; Padala, Prasad; Brawman-Mintzer, Olga; Burke, William; Craft, Suzanne; Lerner, Alan J; Levey, Allan; Porsteinsson, Anton; van Dyck, Christopher H

    2018-01-18

    Alzheimer's disease (AD) is characterized not only by cognitive and functional decline, but also often by the presence of neuropsychiatric symptoms. Apathy, which can be defined as a lack of motivation, is one of the most prevalent neuropsychiatric symptoms in AD and typically leads to a worse quality of life and greater burden for caregivers. Treatment options for apathy in AD are limited, but studies have examined the use of the amphetamine, methylphenidate. The Apathy in Dementia Methylphenidate Trial (ADMET) found that treatment of apathy in AD with methylphenidate was associated with significant improvement in apathy in two of three outcome measures, some evidence of improvement in global cognition, and minimal adverse events. However, the trial only enrolled 60 participants who were followed for only 6 weeks. A larger, longer-lasting trial is required to confirm these promising findings. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a phase III, placebo-controlled, masked, 6-month, multi-center, randomized clinical trial targeted to enroll 200 participants with AD and apathy. Participants are randomly assigned 1:1 to 20 mg methylphenidate per day prepared as four over-encapsulated tablets or to matching placebo. The primary outcomes include (1) the mean difference in the Neuropsychiatric Inventory Apathy subscale scores measured as change from baseline to 6 months, and (2) the odds of having a given rating or better on the modified AD Cooperative Study Clinical Global Impression of Change ratings at month 6 compared with the baseline rating. Other outcomes include change in cognition, safety, and cost-effectiveness measured at monthly follow-up visits up to 6 months. Given the prevalence of apathy in AD and its impact on both patients and caregivers, an intervention to alleviate apathy would be of great benefit to society. ADMET 2 follows on the promising results from the original ADMET to evaluate the efficacy of methylphenidate as a

  6. COLLABORATIVE TRIAL AND QUALITY CONTROL IN CHEMICAL ANALYSIS

    Directory of Open Access Journals (Sweden)

    Narsito Narsito

    2010-06-01

    Full Text Available Abstract                                                             This paper deals with some practical problems related to the quality of analytical chemical data usually met in practice. Special attention is given to the topic of quality control in analytical chemistry, since analytical data is one of the primary information from which some important scientifically based decision are to be made. The present paper starts with brief description on some fundamental aspects associated with quality of analytical data, such as sources of variation of analytical data, criteria for quality of analytical method, quality assurance in chemical analysis. The assessment of quality parameter for analytical method like the use of standard materials as well as standard methods is given. Concerning with the quality control of analytical data, the use of several techniques, such as control samples and control charts, in monitoring analytical data in quality control program are described qualitatively.  In the final part of this paper, some important remarks for the preparation of collaborative trials, including the evaluation of accuracy and reproducibility of analytical method are also given Keywords: collaborative trials, quality control, analytical data Abstract                                                             This paper deals with some practical problems related to the quality of analytical chemical data usually met in practice. Special attention is given to the topic of quality control in analytical chemistry, since analytical data is one of the primary information from which some important scientifically based decision are to be made. The present paper starts with brief description on some fundamental aspects associated with quality of analytical data, such as sources of variation of analytical data, criteria for quality of

  7. Effects of nattokinase on blood pressure: a randomized, controlled trial.

    Science.gov (United States)

    Kim, Ji Young; Gum, Si Nae; Paik, Jean Kyung; Lim, Hyo Hee; Kim, Kyong-Chol; Ogasawara, Kazuya; Inoue, Kenichi; Park, Sungha; Jang, Yangsoo; Lee, Jong Ho

    2008-08-01

    The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; pnattokinase group compared with the control group (pnattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension.

  8. Encouraging GPs to undertake screening and a brief intervention in order to reduce problem drinking: a randomized controlled trial

    DEFF Research Database (Denmark)

    Hansen, Lars Jørgen; Olivarius, Niels de Fine; Beich, Anders

    1999-01-01

    intervention, problem drinking, randomized controlled trial, family practice, marketing of health services......intervention, problem drinking, randomized controlled trial, family practice, marketing of health services...

  9. Therapeutic effects of antimicrobial treatment during lactation of recently acquired bovine subclinical mastitis: two linked randomized field trials.

    Science.gov (United States)

    van den Borne, B H P; van Schaik, G; Lam, T J G M; Nielen, M

    2010-01-01

    Two linked randomized field trials were performed on 39 herds in the Netherlands to 1) determine therapeutic effects of antimicrobial treatment of recently acquired subclinical mastitis (RASCM) during lactation, 2) evaluate the effect of duration of subclinical mastitis on therapeutic outcome, and 3) identify factors related to the therapeutic success of RASCM. Cows with a first elevated composite somatic cell count (CSCC) after 2 consecutive low CSCC measurements were eligible for enrollment in trial 1 (treatment at the first elevated CSCC). Quarter milk samples were collected to determine bacteriological status for major pathogens and coagulase-negative staphylococci. Cows with one or more culture-positive quarters with a quarter somatic cell count (QSCC) >or=100,000 cells/mL were defined to have RASCM and were randomly assigned treatment or control (no treatment). Untreated cows from trial 1 that had a second elevated CSCC at the next milk recording were eligible for enrollment in trial 2 (treatment at the second elevated CSCC). In trial 2, staphylococci-positive cows (Staphylococcus aureus and coagulase-negative staphylococci) were randomly assigned to treatment or control. Farmers used their own treatment protocols to treat quarters in both trials. Bacteriological cure was defined as absence of the pathogen identified pre-intervention in 2 samples post-intervention; QSCC, CSCC, and milk yield were also analyzed. Hierarchical logistic and linear models were used to determine therapeutic effects and to identify factors related to therapy outcome. Treated quarters had a higher bacteriological cure rate than control quarters for all pathogens in both trials. Treatment resulted in lower QSCC and CSCC, whereas milk yield was not affected by treatment. Bacteriological cure of RASCM was better in quarters with a low QSCC pre-intervention and in coagulase-negative staphylococci-positive quarters. Control quarters with a single culture-positive sample pre

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

    Directory of Open Access Journals (Sweden)

    Zielinski Stephanie M

    2012-01-01

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

  11. Exercise and manual physiotherapy arthritis research trial (EMPART): a multicentre randomised controlled trial.

    LENUS (Irish Health Repository)

    French, Helen P

    2009-01-01

    Osteoarthritis (OA) of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT) found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy.

  12. The Chronic Kidney Disease Water Intake Trial: Protocol of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    William F. Clark

    2017-08-01

    Full Text Available Background: In observational studies, drinking more water associates with a slower rate of kidney function decline; whether the same is true in a randomized controlled trial is unknown. Objective: To examine the 1-year effect of a higher vs usual water intake on estimated glomerular filtration rate (eGFR in patients with chronic kidney disease. Design: Parallel-group randomized controlled trial. Setting: Nine centers in Ontario, Canada. Enrollment and randomization occurred between May 2013 and May 2016; follow-up for the primary outcome will continue until June 2017. Participants: Adults (n = 631 with stage 3 chronic kidney disease (eGFR 30-60 mL/min/1.73 m 2 and microalbuminuria. Intervention: The high water intake group was coached to increase their oral water intake by 1.0 to 1.5 L/day (depending on sex and weight, over and above usual consumed beverages, for a period of 1 year. The control group was coached to maintain their usual water intake during this time. Measures: Participants provided 24-hour urine samples at baseline and at 6 and 12 months after randomization; urine samples were analyzed for volume, creatinine, osmolality, and the albumin-to-creatinine ratio. Blood samples were obtained at baseline and at 3- to 6-month intervals after randomization, and analyzed for creatinine, copeptin, osmolality, and electrolytes. Other measures collected included health-related quality of life, blood pressure, body mass index, and diet. Primary outcome: The between-group change in eGFR from baseline (prerandomization to 12 months after randomization. Secondary outcomes: Change in plasma copeptin concentration, 24-hour urine albumin-to-creatinine ratio, measured creatinine clearance, estimated 5-year risk of kidney failure (using the 4-variable Kidney Failure Risk Equation, and health-related quality of life. Planned analysis: The primary analysis will follow an intention-to-treat approach. The between-group change in eGFR will be compared using

  13. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  14. The VICI-trial: high frequency oscillation versus conventional mechanical ventilation in newborns with congenital diaphragmatic hernia: an international multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van den Hout Lieke

    2011-11-01

    Full Text Available Abstract Background Congenital diaphragmatic hernia (CDH is a severe congenital anomaly of the diaphragm resulting in pulmonary hypoplasia and pulmonary hypertension. It is associated with a high risk of mortality and pulmonary morbidity. Previous retrospective studies have reported high frequency oscillatory ventilation (HFO to reduce pulmonary morbidity in infants with CDH, while others indicated HFO to be associated with worse outcome. We therefore aimed to develop a randomized controlled trial to compare initial ventilatory treatment with high-frequency oscillation and conventional ventilation in infants with CDH. Methods/design This trial is designed as a multicentre trial in which 400 infants (200 in each arm will be included. Primary outcome measures are BPD, described as oxygen dependency by day 28 according to the definition of Jobe and Bancalari, and/or mortality by day 28. All liveborn infants with CDH born at a gestational age of over 34 weeks and no other severe congenital anomalies are eligible for inclusion. Parental informed consent is asked antenatally and the allocated ventilation mode starts within two hours after birth. Laboratory samples of blood, urine and tracheal aspirate are taken at the first day of life, day 3, day 7, day 14 and day 28 to evaluate laboratory markers for ventilator-induced lung injury and pulmonary hypertension. Discussion To date, randomized clinical trials are lacking in the field of CDH. The VICI-trial, as the first randomized clinical trial in the field of CDH, may provide further insight in ventilation strategies in CDH patient. This may hopefully prevent mortality and morbidity. Trial registration Netherlands Trial Register (NTR: NTR1310

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

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  16. ORCHIDS: an Observational Randomized Controlled Trial on Childhood Differential Susceptibility

    Directory of Open Access Journals (Sweden)

    Chhangur Rabia R

    2012-10-01

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

  17. Acupucture as pain relief during delivery - a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    Background: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. Methods: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... to existing pain relief methods. (BIRTH 36:1 March 2009)...

  18. Control of Levitating Particle in Ultrasound Field

    Directory of Open Access Journals (Sweden)

    Sukhanov Dmitry

    2018-01-01

    Full Text Available The experimental setup for ultrasonic controlled levitation in the air has been developed. Two phased arrays made of 91 ultrasonic radiators placed in front of each other are used. Arrays are focused in the region of particle levitation. The length of the focus area allows us to move the particles along it, controlling the standing waves through the phase difference of the two arrays.

  19. Family in Focus: On Design and Field Trial of the Dynamic Collage [DC

    NARCIS (Netherlands)

    René Bakker; Koen van Turnhout; Jasper Jeurens

    2014-01-01

    In this paper we present the design and field trial of the Dynamic Collage. The Dynamic Collage was designed to facilitate and to stimulate participation of family members in the informal care of an elderly person. The Dynamic Collage enabled relatives to update their current activity by sending a

  20. Phytoremediation prospects of willow stands on contaminated sediment : A field trial

    NARCIS (Netherlands)

    Vervaeke, P; Luyssaert, S.; Mertens, J.; Meers, E.; Tack, F. M.G.; Lust, N

    2003-01-01

    Establishing fast growing willow stands on land disposed contaminated dredged sediment can result in the revaluation of this material and opens possibilities for phytoremediation. A field trial was designed to assess the impact of planting a willow stand (Salix viminalis L. 'Orm') on the dissipation

  1. Looking ahead – How field trials can work in iterative and exploratory design of ubicomp systems

    DEFF Research Database (Denmark)

    Korn, Matthias; Bødker, Susanne

    2012-01-01

    . To introduce a sophisticated version of our own prototype in the course of an iterative design process, we conducted a public field trial of the system—a new platform for mobile democratic discussions in municipal planning—that we distributed via the Android Market. However, it turned out to be surprisingly...

  2. Iterative design and field trial of an aphasia-friendly email tool

    NARCIS (Netherlands)

    Al Mahmud, A.; Martens, J.B.O.S.

    2015-01-01

    In this article, we describe the iterative design and field trial of Amail, an email client specifically designed for people with aphasia who have problems expressing themselves verbally. We conducted a 3-month study with eight persons with aphasia to better understand how people with aphasia could

  3. Controlling Charged Particles with Inhomogeneous Electrostatic Fields

    Science.gov (United States)

    Herrero, Federico A. (Inventor)

    2016-01-01

    An energy analyzer for a charged-particle spectrometer may include a top deflection plate and a bottom deflection plate. The top and bottom deflection plates may be non-symmetric and configured to generate an inhomogeneous electrostatic field when a voltage is applied to one of the top or bottom deflection plates. In some instances, the top and bottom deflection plates may be L-shaped deflection plates.

  4. Modelling spatial trends in sorghum breeding field trials using a two-dimensional P-spline mixed model

    NARCIS (Netherlands)

    Velazco, Julio G.; Rodríguez-Álvarez, María Xosé; Boer, Martin P.; Jordan, David R.; Eilers, Paul H.C.; Malosetti, Marcos; Eeuwijk, van Fred A.

    2017-01-01

    Key message: A flexible and user-friendly spatial method called SpATS performed comparably to more elaborate and trial-specific spatial models in a series of sorghum breeding trials. Abstract: Adjustment for spatial trends in plant breeding field trials is essential for efficient evaluation and

  5. Modelling spatial trends in sorghum breeding field trials using a two-dimensional P-spline mixed model

    NARCIS (Netherlands)

    J.G. Velazco (Julio G.); M.X. Rodríguez-Álvarez (María Xosé); M.P. Boer (Martin); D.R. Jordan (David R.); P.H.C. Eilers (Paul); M. Malosetti (Marcos); F. van Eeuwijk (Fred)

    2017-01-01

    markdownabstract_Key message: A flexible and user-friendly spatial method called SpATS performed comparably to more elaborate and trial-specific spatial models in a series of sorghum breeding trials._ __Abstract:__ Adjustment for spatial trends in plant breeding field trials is essential for

  6. A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery.

    Science.gov (United States)

    Voineskos, Sophocles H; Coroneos, Christopher J; Ziolkowski, Natalia I; Kaur, Manraj N; Banfield, Laura; Meade, Maureen O; Chung, Kevin C; Thoma, Achilleas; Bhandari, Mohit

    2016-02-01

    The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently. An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis. The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87). Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.

  7. Effect of Dexmedetomidine and Propofol on Basal Ganglia Activity in Parkinson Disease: A Controlled Clinical Trial.

    Science.gov (United States)

    Martinez-Simon, Antonio; Alegre, Manuel; Honorato-Cia, Cristina; Nuñez-Cordoba, Jorge M; Cacho-Asenjo, Elena; Trocóniz, Iñaki F; Carmona-Abellán, Mar; Valencia, Miguel; Guridi, Jorge

    2017-06-01

    Deep brain stimulation electrodes can record oscillatory activity from deep brain structures, known as local field potentials. The authors' objective was to evaluate and quantify the effects of dexmedetomidine (0.2 μg·kg·h) on local field potentials in patients with Parkinson disease undergoing deep brain stimulation surgery compared with control recording (primary outcome), as well as the effect of propofol at different estimated peak effect site concentrations (0.5, 1.0, 1.5, 2.0, and 2.5 μg/ml) from control recording. A nonrandomized, nonblinded controlled clinical trial was carried out to assess the change in local field potentials activity over time in 10 patients with Parkinson disease who underwent deep brain stimulation placement surgery (18 subthalamic nuclei). The relationship was assessed between the activity in nuclei in the same patient at a given time and repeated measures from the same nucleus over time. No significant difference was observed between the relative beta power of local field potentials in dexmedetomidine and control recordings (-7.7; 95% CI, -18.9 to 7.6). By contrast, there was a significant decline of 12.7% (95% CI, -21.3 to -4.7) in the relative beta power of the local field potentials for each increment in the estimated peak propofol concentrations at the effect site relative to the control recordings. Dexmedetomidine (0.2 μg·kg·h) did not show effect on local field potentials compared with control recording. A significant deep brain activity decline from control recording was observed with incremental doses of propofol.

  8. A controlled trial of renal denervation for resistant hypertension.

    Science.gov (United States)

    Bhatt, Deepak L; Kandzari, David E; O'Neill, William W; D'Agostino, Ralph; Flack, John M; Katzen, Barry T; Leon, Martin B; Liu, Minglei; Mauri, Laura; Negoita, Manuela; Cohen, Sidney A; Oparil, Suzanne; Rocha-Singh, Krishna; Townsend, Raymond R; Bakris, George L

    2014-04-10

    Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension. We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months. A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group (Pdenervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P=0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups. This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. (Funded by Medtronic; SYMPLICITY HTN-3 ClinicalTrials.gov number, NCT01418261.).

  9. Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

    Science.gov (United States)

    Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; DE Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

    2017-12-01

    Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.

  10. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

    Science.gov (United States)

    Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

    2014-01-01

    Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. SLEEP 2014;37(9):1553-1563. PMID:25142566

  11. A study on environmental pollution control in energy field

    Energy Technology Data Exchange (ETDEWEB)

    Min, B.M.; Son, J.E.; Lee, H.K.; Choi, W.K.; Baek, I.H.; Lee, J.S. [Korea Inst. of Energy Research, Taejon (Korea, Republic of)

    1995-12-01

    This report is contained such as following contents; Preparation of the stepwise pollution control strategies to reduce pollutants in energy field, which will be satisfy to tightened emission standard in the future. Analysis of the environmental pollution control technologies level, which related to energy field in domestic and other countries. Visualization of the reduction strategies of domestic carbon dioxide emission in energy field. And, discussion and proposal of the R and D program to improve the domestic environmental pollution control technologies in energy field. (author). 99 refs., 67 figs., 73 tabs.

  12. Antenatal hypnosis training and childbirth experience: a randomized controlled trial.

    Science.gov (United States)

    Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Wu, Chun Sen; Nohr, Ellen A

    2013-12-01

    Childbirth is a demanding event in a woman's life. The aim of this study was to explore whether a brief intervention in the form of an antenatal course in self-hypnosis to ease childbirth could improve the childbirth experience. In a randomized, controlled, single-blinded trial, 1,222 healthy nulliparous women were allocated to one of three groups during pregnancy: A hypnosis group participating in three 1-hour sessions teaching self-hypnosis to ease childbirth, a relaxation group receiving three 1-hour lessons in various relaxation methods and Mindfulness, and a usual care group receiving ordinary antenatal care only. Wijmas Delivery Expectancy/Experience Questionnaire (W-DEQ) was used to measure the childbirth experience 6 weeks postpartum. The intention-to-treat analysis indicated that women in the hypnosis group experienced their childbirth as better compared with the other two groups (mean W-DEQ score of 42.9 in the Hypnosis group, 47.2 in the Relaxation group, and 47.5 in the Care as usual group (p = 0.01)). The tendency toward a better childbirth experience in the hypnosis group was also seen in subgroup analyses for mode of delivery and for levels of fear. In this large randomized controlled trial, a brief course in self-hypnosis improved the women's childbirth experience. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.

  13. Assessing validity of observational intervention studies - the Benchmarking Controlled Trials.

    Science.gov (United States)

    Malmivaara, Antti

    2016-09-01

    Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. To create and pilot test a checklist for appraising methodological validity of a BCT. The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies. Key messages Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies.

  14. Sleep disorders in patients with depression or schizophrenia: A randomized controlled trial using acupuncture treatment

    NARCIS (Netherlands)

    Bosch, M.P.C.; Noort, M.W.M.L. van den; Staudte, H.; Lim, S.; Yeo, S.; Coenen, A.M.L.; Luijtelaar, E.L.J.M. van

    2016-01-01

    Introduction: The purpose of this preliminary clinical trial was to investigate whether acupuncture has a positive influence on sleep and symptomatology in patients with schizophrenia or depression. Methods: A randomized controlled trial was used. One hundred participants were recruited: 40

  15. RF field control for Kaon Factory booster cavities

    International Nuclear Information System (INIS)

    Craig, S.T.; de Jong, M.S.

    1992-08-01

    A conceptual design is developed for control of the Kaon Factory booster rf accelerating fields. This design addresses control of cavity: tuning, voltage amplitude, and voltage phase angle. Time-domain simulations were developed to evaluate the proposed controllers. These simulations indicate that adequate tuning performance can be obtained with the combination of adaptive feed forward and proportional feedback control. Voltage amplitude and voltage phase can be adequately controlled using non-adaptive feed forward and proportional feedback control. (Author) (figs., tabs.)

  16. RF field control for KAON Factory booster cavities

    International Nuclear Information System (INIS)

    Craig, S.T.; de Jong, M.S.

    1990-11-01

    A conceptual design is developed for control of the KAON Factory Booster rf accelerating fields. This design addresses control of cavity: tuning, voltage amplitude, and voltage phase angle. Time-domain simulations were developed to evaluated the proposed controllers. These simulations indicated that adequate tuning performance can be obtained with the combination of adaptive feed-forward and proportional feedback control. Voltage amplitude and voltage phase can be adequately controlled using non-adaptive feedforward and proportional feedback control

  17. Optimising and Evaluating the Characteristics of a Multiple Antigen ELISA for Detection of Mycobacterium bovis Infection in a Badger Vaccine Field Trial

    NARCIS (Netherlands)

    Aznar, I.; Frankena, K.; More, S.J.; Whelan, C.; Martin, W.; Gormley, E.; Corner, L.A.L.; Murphy, D.; Jong, de M.C.M.

    2014-01-01

    A long-term research programme has been underway in Ireland to evaluate the usefulness of badger vaccination as part of the national bTB (bovine tuberculosis) control strategy. This culminated in a field trial which commenced in county Kilkenny in 2009 to determine the effects of badger vaccination

  18. Effect of Playful Balancing Training - A Pilot Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Lund, Henrik Hautop; Jessen, Jari Due

    2013-01-01

    We used the modular playware in the form of modular interactive tiles for playful training of community-dwelling elderly with balancing problem. During short-term play on the modular interactive tiles, the elderly were playing physical, interactive games that were challenging their dynamic balance...... increase in balancing performance (DGI score: 21.3) after short-term playful training with the modular interactive tiles, whereas the control group remained with a score indicating balancing problems and risk of falling (DGI score: 16.6). The small pilot randomized controlled trial suggests...... that the playful interaction with the modular interactive tiles has a significant effect even after a very short time of play. The average total training time to obtain the statistical significant effect amounted to just 2h45m....

  19. A randomized controlled trial of an electronic informed consent process.

    Science.gov (United States)

    Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

    2014-12-01

    A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

  20. (Costeffectiveness of life review for Older Adults: Design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Onrust Simone

    2008-06-01

    Full Text Available Abstract Background Depression in older adults is a serious health problem with a poor prognosis. There is a need for indicated preventive psychological interventions for older adults, that show to be promising in preventing depressive disorders. Methods/design This manuscript describes the design of a study evaluating 'Looking for Meaning', a newly developed prevention course for older adults with depressive symptoms, based on life-review. Both clinical and economic effectiveness are evaluated in a pragmatic randomized controlled trial. The control condition of this 12-session preventive intervention is a 20-minute video movie. The primary outcome is symptoms of depression at post-treatment and follow-up (6 months after post-treatment. Secondary outcomes are symptoms of anxiety, satisfaction with life, mastery, reminiscence styles, quality of life, and health care costs. An additional result of this study is the insight into the working elements of the course, provided by the qualitative study. The qualitative data, mainly based on 20 open-ended interviews with participants, are to be analyzed with an emphasis on newly emerging insight. Discussion This study will add to the existing scientific knowledge in several ways, especially by also including an economic evaluation and a qualitative study to gain insight into the working mechanisms of the course, both rather new in the field of life review. Positive results of this study will make an evidence-based intervention to improve public health among older people available. Trial registration Current Controlled Trials Ltd, ISRCTN66645855

  1. The Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre randomised controlled trial: baseline patient characteristics.

    Science.gov (United States)

    Konstantakopoulou, Evgenia; Gazzard, Gus; Vickerstaff, Victoria; Jiang, Yuzhen; Nathwani, Neil; Hunter, Rachael; Ambler, Gareth; Bunce, Catey

    2018-05-01

    The laser in glaucoma and ocular hypertension (LiGHT) trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open angle glaucoma (POAG) or ocular hypertension (OHT). LiGHT is a prospective unmasked, multicentre, pragmatic, randomised controlled trial (RCT). 718 previously untreated patients with POAG or OHT were recruited at 6 UK centres between 2012 and 2014. Patients were randomised to initial SLT followed by medical therapy or medical therapy without laser. Participants will be monitored for 3 years, according to routine clinical practice. The primary outcome is EQ-5D-5L. Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index (GUI), Glaucoma Symptom Scale, Glaucoma Quality of Life (GQL), pathway effectiveness, visual function, safety and concordance. A total of 555 patients had POAG and 163 OHT; 518 patients had both eyes eligible. The mean age for patients with POAG was 64 years and for OHT 58 years. 70% of all participants were white. Median IOP for OHT eyes was 26 mm Hg and 23 mm Hg for POAG eyes. Median baseline visual field mean deviation was -0.81 dB for OHT eyes and -2.82 dB for POAG eyes. There was no difference between patients with POAG and patients with OHT on the EQ-5D-5DL; the difference between OHT and POAG on the GUI was -0.02 and 1.23 on the GQL. The LiGHT trial is the first RCT to compare the two treatment options in a real-world setting. The baseline characteristics of the LiGHT cohort compare well with other landmark glaucoma studies. ISRCTN32038223, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  2. Neonatal ECMO Study of Temperature (NEST - a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Juszczak Edmund

    2010-04-01

    Full Text Available Abstract Background Existing evidence indicates that once mature neonates with severe cardio-respiratory failure become eligible for Extra Corporeal Membrane Oxygenation (ECMO their chances of intact survival are doubled if they actually receive ECMO. However, significant numbers survive with disability. NEST is a multi-centre randomised controlled trial designed to test whether, in neonates requiring ECMO, cooling to 34°C for the first 48 to 72 hours of their ECMO course leads to improved later health status. Infants allocated to the control group will receive ECMO at 37°C throughout their course, which is currently standard practice around the world. Health status of both groups will be assessed formally at 2 years corrected age. Methods/Design All infants recruited to the study will be cared for in one of the four United Kingdom (UK ECMO centres. Babies who are thought to be eligible will be assessed by the treating clinician who will confirm eligibility, ensure that consent has been obtained and then randomise the baby using a web based system, based at the National Perinatal Epidemiology Unit (NPEU Clinical Trials Unit. Trial registration. Babies allocated ECMO without cooling will receive ECMO at 37°C ± 0.2°C. Babies allocated ECMO with cooling will be managed at 34°C ± 0.2°C for up to 72 hours from the start of their ECMO run. The minimum duration of cooling will be 48 hours. Rewarming (to 37°C will occur at a rate of no more than 0.5°C per hour. All other aspects of ECMO management will be identical. Primary outcome: Cognitive score from the Bayley Scales of Infant and Toddler Development, 3rd edition (Bayley-III at age of 2 years (24 - 27 months. Discussion For the primary analysis, children will be analysed in the groups to which they are assigned, comparing the outcome of all babies allocated to "ECMO with cooling" with all those allocated to "ECMO" alone, regardless of deviation from the protocol or treatment received. For

  3. Fusion bonded epoxy mainline and field joint coatings performance from the X100 field trial – A case study

    International Nuclear Information System (INIS)

    Jadoon, A.N.K.; Thompson, I.

    2012-01-01

    Operating and distribution companies are potentially interested in the use of high and ultra-high strength steels for the transportation of high pressure gas. The ultra-high strength X100 grade steel was commercially developed as a potential option to meet this. However, there has been limited industry wide use of X100 to date. BP carried out a 2 year field trial to demonstrate the operational capacity and integrity of a large diameter (48 inch/1219 mm) high pressure pipeline constructed from X100 grade steel. The 800 m pipeline was buried in a clay backfill and exposed to wet ground conditions associated with the North of England. Flow pressure cycling was carried out, using water, to simulate 40 years of operational service. A 200 m section of the pipeline was exposed to three different potential (cathodic protection) zones for the duration of the trial: zero potential, intermediate potential (−850 to −950 mV) and high potential (−1200 to −1300 mV). This section also had damage and defects induced which are typically associated with bad installation and commissioning. An area of potential concern is the degradation of the mechanical properties (strain ageing) due to the external coating application temperature. Thus, a low coating application temperature is deemed desirable. The mainline and field joint coatings employed for the trial were fusion bonded epoxy (FBE). Both of these have been used in other BP projects, with a good track record. They were applied at a lower application temperature of 220 °C, compared to the more typical 230–240 °C. The lower application temperature was within the manufacturers approved application and curing temperature range. The lower temperature was used to assess the ultimate performance properties of the mainline and field joint FBE coatings. Mainline and field joint coating samples were taken from the three different potential zones and extensive testing and characterisation carried out. This paper presents and

  4. Fusion bonded epoxy mainline and field joint coatings performance from the X100 field trial - A case study

    Energy Technology Data Exchange (ETDEWEB)

    Jadoon, A.N.K., E-mail: ammer.jadoon@bp.com [BP Exploration and Production Technology, Chertsey Road, Sunbury TW16-7LN (United Kingdom); Thompson, I. [GL Industrial Services UK, Holywell Park, Loughborough LE11-3GR (United Kingdom)

    2012-04-15

    Operating and distribution companies are potentially interested in the use of high and ultra-high strength steels for the transportation of high pressure gas. The ultra-high strength X100 grade steel was commercially developed as a potential option to meet this. However, there has been limited industry wide use of X100 to date. BP carried out a 2 year field trial to demonstrate the operational capacity and integrity of a large diameter (48 inch/1219 mm) high pressure pipeline constructed from X100 grade steel. The 800 m pipeline was buried in a clay backfill and exposed to wet ground conditions associated with the North of England. Flow pressure cycling was carried out, using water, to simulate 40 years of operational service. A 200 m section of the pipeline was exposed to three different potential (cathodic protection) zones for the duration of the trial: zero potential, intermediate potential (-850 to -950 mV) and high potential (-1200 to -1300 mV). This section also had damage and defects induced which are typically associated with bad installation and commissioning. An area of potential concern is the degradation of the mechanical properties (strain ageing) due to the external coating application temperature. Thus, a low coating application temperature is deemed desirable. The mainline and field joint coatings employed for the trial were fusion bonded epoxy (FBE). Both of these have been used in other BP projects, with a good track record. They were applied at a lower application temperature of 220 Degree-Sign C, compared to the more typical 230-240 Degree-Sign C. The lower application temperature was within the manufacturers approved application and curing temperature range. The lower temperature was used to assess the ultimate performance properties of the mainline and field joint FBE coatings. Mainline and field joint coating samples were taken from the three different potential zones and extensive testing and characterisation carried out. This paper

  5. Pediatric obesity pharmacotherapy: current state of the field, review of the literature and clinical trial considerations.

    Science.gov (United States)

    Kelly, A S; Fox, C K; Rudser, K D; Gross, A C; Ryder, J R

    2016-07-01

    Despite the increasing number of medications recently approved to treat obesity among adults, few agents have been formally evaluated in children or adolescents for this indication. Moreover, there is a paucity of guidance in the literature addressing best practices with regard to pediatric obesity pharmacotherapy clinical trial design, and only general recommendations have been offered by regulatory agencies on this topic. The purposes of this article are to (1) offer a background of the current state of the field of pediatric obesity medicine, (2) provide a brief review of the literature summarizing pediatric obesity pharmacotherapy clinical trials, and (3) highlight and discuss some of the unique aspects that should be considered when designing and conducting high-quality clinical trials evaluating the safety and efficacy of obesity medications in children and adolescents. Suggestions are offered in the areas of target population and eligibility criteria, clinical trial end-point selection, trial duration, implementation of lifestyle modification therapy and recruitment and retention of participants. Efforts should be made to design and conduct trials appropriately to ensure that high-quality evidence is generated on the safety and efficacy of various medications used to treat pediatric obesity.

  6. Moxibustion for breech version: a randomized controlled trial.

    Science.gov (United States)

    Guittier, Marie-Julia; Pichon, Michelle; Dong, Hongguang; Irion, Olivier; Boulvain, Michel

    2009-11-01

    To estimate the efficacy of moxibustion between 34 and 38 weeks of gestation to facilitate the cephalic version of fetuses in breech presentation and the acceptability of this method by women. We conducted a randomized controlled trial in a Swiss university hospital maternity unit. We proposed to stimulate the acupoint BL 67 by moxibustion daily for 2 weeks for 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation. We did the intervention three times weekly in the hospital and a teaching session and information leaflet on the technique for additional daily therapy at home. The control group received expectant management care. The availability of external cephalic version was maintained for both groups. The main outcome measure was the comparison of the proportion of women with cephalic presentation at delivery. Baseline characteristics were similar between groups, except more nulliparous women were randomized to moxibustion. The percentage of versions was similar between groups: 18% in the moxibustion group compared with 16% in the control group (relative risk 1.12, 95% confidence interval 0.62 to 2.03). Adjustment for the imbalance in parity did not change these results. The frequency of cesarean delivery was similar (64% compared with 58% in the moxibustion group and the control group, respectively). Acceptability of the intervention and women's perceptions of moxibustion were favorable. We observed no beneficial effect of moxibustion to facilitate the cephalic version of fetuses in breech presentation. Despite this lack of proven effectiveness, women had positive opinions on the intervention. ClinicalTrials.gov, www.clinicaltrials.gov,NCT00890474. I.

  7. The INCA trial (Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver Cirrhosis and Ascites): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Casper, Markus; Mengel, Martin; Fuhrmann, Christine; Herrmann, Eva; Appenrodt, Beate; Schiedermaier, Peter; Reichert, Matthias; Bruns, Tony; Engelmann, Cornelius; Grünhage, Frank; Lammert, Frank

    2015-03-08

    Patients with liver cirrhosis have a highly elevated risk of developing bacterial infections that significantly decrease survival rates. One of the most relevant infections is spontaneous bacterial peritonitis (SBP). Recently, NOD2 germline variants were found to be potential predictors of the development of infectious complications and mortality in patients with cirrhosis. The aim of the INCA (Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver Cirrhosis and Ascites) trial is to investigate whether survival of this genetically defined high-risk group of patients with cirrhosis defined by the presence of NOD2 variants is improved by primary antibiotic prophylaxis of SBP. The INCA trial is a double-blind, placebo-controlled clinical trial with two parallel treatment arms (arm 1: norfloxacin 400 mg once daily; arm 2: placebo once daily; 12-month treatment and observational period). Balanced randomization of 186 eligible patients with stratification for the protein content of the ascites (INCA trial is first in the field of hepatology aimed at rapidly transferring and validating information on individual genetic risk into clinical decision algorithms. German Clinical Trials Register DRKS00005616 . Registered 22 January 2014. EU Clinical Trials Register EudraCT 2013-001626-26 . Registered 26 January 2015.

  8. The efficacy of a movement control exercise programme to reduce injuries in youth rugby: a cluster randomised controlled trial

    Science.gov (United States)

    Hislop, M D; Stokes, K A; Williams, S; McKay, C D; England, M; Kemp, S P T

    2016-01-01

    Background Injuries to youth rugby players have become an increasingly prominent health concern, highlighting the importance of developing and implementing appropriate preventive strategies. A growing body of evidence from other youth sports has demonstrated the efficacy of targeted exercise regimens to reduce injury risk. However, studies have yet to investigate the effect of such interventions in youth contact sport populations like rugby union. Objective To determine the efficacy of an evidence-based movement control exercise programme compared with a sham exercise programme to reduce injury risk in youth rugby players. Exercise programme compliance between trial arms and the effect of coach attitudes on compliance will also be evaluated. Setting School rugby coaches in England will be the target of the researcher intervention, with the effects of the injury prevention programmes being measured in male youth players aged 14–18 years in school rugby programmes over the 2015–2016 school winter term. Methods A cluster-randomised controlled trial with schools randomly allocated to either a movement control exercise programme or a sham exercise programme, both of which are coach-delivered. Injury measures will derive from field-based injury surveillance, with match and training exposure and compliance recorded. A questionnaire will be used to evaluate coach attitudes, knowledge, beliefs and behaviours both prior to and on the conclusion of the study period. Outcome measures Summary injury measures (incidence, severity and burden) will be compared between trial arms, as will the influence of coach attitudes on compliance and injury burden. Additionally, changes in these outcomes through using the exercise programmes will be evaluated. Trial registration number ISRTCNN13422001. PMID:27900148

  9. Restoration of a Mediterranean forest after a fire: bioremediation and rhizoremediation field-scale trial.

    Science.gov (United States)

    Pizarro-Tobías, Paloma; Fernández, Matilde; Niqui, José Luis; Solano, Jennifer; Duque, Estrella; Ramos, Juan-Luis; Roca, Amalia

    2015-01-01

    Forest fires pose a serious threat to countries in the Mediterranean basin, often razing large areas of land each year. After fires, soils are more likely to erode and resilience is inhibited in part by the toxic aromatic hydrocarbons produced during the combustion of cellulose and lignins. In this study, we explored the use of bioremediation and rhizoremediation techniques for soil restoration in a field-scale trial in a protected Mediterranean ecosystem after a controlled fire. Our bioremediation strategy combined the use of Pseudomonas putida strains, indigenous culturable microbes and annual grasses. After 8 months of monitoring soil quality parameters, including the removal of monoaromatic and polycyclic aromatic hydrocarbons as well as vegetation cover, we found that the site had returned to pre-fire status. Microbial population analysis revealed that fires induced changes in the indigenous microbiota and that rhizoremediation favours the recovery of soil microbiota in time. The results obtained in this study indicate that the rhizoremediation strategy could be presented as a viable and cost-effective alternative for the treatment of ecosystems affected by fires. © 2014 The Authors. Microbial Biotechnology published by John Wiley & Sons Ltd and Society for Applied Microbiology.

  10. Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

    Science.gov (United States)

    Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

    2010-01-01

    In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

  11. Electroacupuncture treatment for pancreatic cancer pain: a randomized controlled trial.

    Science.gov (United States)

    Chen, Hao; Liu, Tang-Yi; Kuai, Le; Zhu, Ji; Wu, Cai-Jun; Liu, Lu-Ming

    2013-01-01

    Pancreatic cancer is often accompanied by severe abdominal or back pain. It's the first study to evaluate the analgesic effect of electroacupuncture on pancreatic cancer pain. A randomized controlled trial compared electroacupuncture with control acupuncture using the placebo needle. Sixty patients with pancreatic cancer pain were randomly assigned to the electroacupuncture group (n = 30) and the placebo control group (n = 30). Patients were treated on Jiaji (Ex-B2) points T8-T12 bilaterally for 30 min once a day for 3 days. Pain intensity was assessed with numerical rated scales (NRS) before the treatment (Baseline), after 3 treatments, and 2 days follow-up. Baseline characteristics were similar in the two groups. After 3 treatment, pain intensity on NRS decreased compared with Baseline (-1.67, 95% confidence interval [CI] -1.46 to -1.87) in the electroacupuncture group; there was little change (-0.13, 95% CI 0.08 to -0.35) in control group; the difference between two groups was statistically significant (P electroacupuncture group compared with the control group (P Electroacupuncture was an effective treatment for relieving pancreatic cancer pain. Copyright © 2013 IAP and EPC. Published by Elsevier B.V. All rights reserved.

  12. Overlay control methodology comparison: field-by-field and high-order methods

    Science.gov (United States)

    Huang, Chun-Yen; Chiu, Chui-Fu; Wu, Wen-Bin; Shih, Chiang-Lin; Huang, Chin-Chou Kevin; Huang, Healthy; Choi, DongSub; Pierson, Bill; Robinson, John C.

    2012-03-01

    Overlay control in advanced integrated circuit (IC) manufacturing is becoming one of the leading lithographic challenges in the 3x and 2x nm process nodes. Production overlay control can no longer meet the stringent emerging requirements based on linear composite wafer and field models with sampling of 10 to 20 fields and 4 to 5 sites per field, which was the industry standard for many years. Methods that have emerged include overlay metrology in many or all fields, including the high order field model method called high order control (HOC), and field by field control (FxFc) methods also called correction per exposure. The HOC and FxFc methods were initially introduced as relatively infrequent scanner qualification activities meant to supplement linear production schemes. More recently, however, it is clear that production control is also requiring intense sampling, similar high order and FxFc methods. The added control benefits of high order and FxFc overlay methods need to be balanced with the increased metrology requirements, however, without putting material at risk. Of critical importance is the proper control of edge fields, which requires intensive sampling in order to minimize signatures. In this study we compare various methods of overlay control including the performance levels that can be achieved.

  13. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Directory of Open Access Journals (Sweden)

    Marleine Azar

    Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

  14. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Science.gov (United States)

    Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

    2015-01-01

    Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is

  15. PACE - The first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Day Richard O

    2010-07-01

    Full Text Available Abstract Background Clinical practice guidelines recommend that the initial treatment of acute low back pain (LBP should consist of advice to stay active and regular simple analgesics such as paracetamol 4 g daily. Despite this recommendation in all international LBP guidelines there are no placebo controlled trials assessing the efficacy of paracetamol for LBP at any dose or dose regimen. This study aims to determine whether 4 g of paracetamol daily (in divided doses results in a more rapid recovery from acute LBP than placebo. A secondary aim is to determine if ingesting paracetamol in a time-contingent manner is more effective than paracetamol taken when required (PRN for recovery from acute LBP. Methods/Design The study is a randomised double dummy placebo controlled trial. 1650 care seeking people with significant acute LBP will be recruited. All participants will receive advice to stay active and will be randomised to 1 of 3 treatment groups: time-contingent paracetamol dose regimen (plus placebo PRN paracetamol, PRN paracetamol (plus placebo time-contingent paracetamol or a double placebo study arm. The primary outcome will be time (days to recovery from pain recorded in a daily pain diary. Other outcomes will be pain intensity, disability, function, global perceived effect and sleep quality, captured at baseline and at weeks 1, 2, 4 and 12 by an assessor blind to treatment allocation. An economic analysis will be conducted to determine the cost-effectiveness of treatment from the health sector and societal perspectives. Discussion The successful completion of the trial will provide the first high quality evidence on the effectiveness of the use of paracetamol, a guideline endorsed treatment for acute LBP. Trail registration ACTRN12609000966291.

  16. The VICI-trial: high frequency oscillation versus conventional mechanical ventilation in newborns with congenital diaphragmatic hernia: an international multicentre randomized controlled trial.

    Science.gov (United States)

    van den Hout, Lieke; Tibboel, Dick; Vijfhuize, Sanne; te Beest, Harma; Hop, Wim; Reiss, Irwin

    2011-11-02

    Congenital diaphragmatic hernia (CDH) is a severe congenital anomaly of the diaphragm resulting in pulmonary hypoplasia and pulmonary hypertension. It is associated with a high risk of mortality and pulmonary morbidity. Previous retrospective studies have reported high frequency oscillatory ventilation (HFO) to reduce pulmonary morbidity in infants with CDH, while others indicated HFO to be associated with worse outcome. We therefore aimed to develop a randomized controlled trial to compare initial ventilatory treatment with high-frequency oscillation and conventional ventilation in infants with CDH. This trial is designed as a multicentre trial in which 400 infants (200 in each arm) will be included. Primary outcome measures are BPD, described as oxygen dependency by day 28 according to the definition of Jobe and Bancalari, and/or mortality by day 28. All liveborn infants with CDH born at a gestational age of over 34 weeks and no other severe congenital anomalies are eligible for inclusion. Parental informed consent is asked antenatally and the allocated ventilation mode starts within two hours after birth. Laboratory samples of blood, urine and tracheal aspirate are taken at the first day of life, day 3, day 7, day 14 and day 28 to evaluate laboratory markers for ventilator-induced lung injury and pulmonary hypertension. To date, randomized clinical trials are lacking in the field of CDH. The VICI-trial, as the first randomized clinical trial in the field of CDH, may provide further insight in ventilation strategies in CDH patient. This may hopefully prevent mortality and morbidity. Netherlands Trial Register (NTR): NTR1310.

  17. Pressure ulcers: effectiveness of risk-assessment tools. A randomised controlled trial (the ULCER trial).

    Science.gov (United States)

    Webster, Joan; Coleman, Kerrie; Mudge, Alison; Marquart, Louise; Gardner, Glenn; Stankiewicz, Monica; Kirby, Julie; Vellacott, Catherine; Horton-Breshears, Margaret; McClymont, Alice

    2011-04-01

    To evaluate the effectiveness of two pressure-ulcer screening tools against clinical judgement in preventing pressure ulcers. A single blind randomised controlled trial. A large metropolitan tertiary hospital. 1231 patients admitted to internal medicine or oncology wards. Patients were excluded if their hospital stay was expected to be 2 days or less. Participants allocated to either a Waterlow (n=410) or Ramstadius (n=411) screening tool group or to a clinical judgement group (n=410) where no formal risk screening instrument was used. Incidence of hospital acquired pressure ulcers ascertained by regular direct observation. Use of any devices for the prevention of pressure ulcers, documentation of a pressure plan and any dietetic or specialist skin integrity review were recorded. On admission, 71 (5.8%) patients had an existing pressure ulcer. The incidence of hospital-acquired pressure ulcers was similar between groups (clinical judgement 28/410 (6.8%); Waterlow 31/411 (7.5%); Ramstadius 22/410 (5.4%), p=0.44). Significant associations with pressure injury in regression modelling included requiring a dietetic referral, being admitted from a location other than home and age over 65 years. The authors found no evidence to show that two common pressure-ulcer risk-assessment tools are superior to clinical judgement to prevent pressure injury. Resources associated with use of these tools might be better spent on careful daily skin inspection and improving management targetted at specific risks. The trial was registered with the Australian and New Zealand Clinicat Trials Registry (ACTRN 12608000541303).

  18. Preoperative clonidine use in trans-sphenoidal pituitary adenoma surgeries - a randomized controlled trial.

    Science.gov (United States)

    Bajaj, Jitin; Mittal, Radhe Shyam; Sharma, Achal

    2017-02-01

    Pituitary masses are common lesions accounting for about 15-20% of all brain tumours. Oozing blood is an annoyance in microscopic sublabial trans-sphenoidal approach for these masses. There have been many ways of reducing the ooze, having their own pros and cons. To find out the efficacy and safety of clonidine in reducing blood loss in pituitary adenoma surgery through a randomized masked trial. It was a prospective randomized controlled trial done. Total 50 patients of pituitary adenomas were randomized into two groups. Group A (25 patients) was given 200 μg clonidine orally, while Group B (25 patients) was given placebo. Surgeon, anaesthesiologist and patient were blinded for the trial. Sublabial trans-septal trans-sphenoidal approach to sella and excision of mass was performed in each patient. Patients were studied for pre-, intra- and post-operative blood pressure and heart rate, pre- and post-operative imaging findings, intra-operative blood loss, bleeding grading by surgeon, surgeon's satisfaction about condition of specific part and quality of surgical field, operative time and extent of resection. Blood loss during the surgery, operative time and bleeding grading by the surgeon were found significantly less in the clonidine group, while quality of surgical field, condition of the specific part and extent of resection were found significantly better in the clonidine group (p value trans-sphenoidal microscopic pituitary adenoma surgeries.

  19. Acupuncture for dry eye: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Kim Ae-Ran

    2009-12-01

    Full Text Available Abstract Background Dry eye is usually managed by conventional medical interventions such as artificial tears, anti-inflammatory drugs and surgical treatment. However, since dry eye is one of the most frequent ophthalmologic disorders, safer and more effective methods for its treatment are necessary, especially for vulnerable patients. Acupuncture has been widely used to treat patients with dry eye. Our aim is to evaluate the effectiveness and safety of acupuncture for this condition. Methods/Design A randomised, patient-assessor blinded, sham (non-acupuncture point, shallow acupuncture controlled study was established. Participants allocated to verum acupuncture and sham acupuncture groups will be treated three times weekly for three weeks for a total of nine sessions per participant. Seventeen points (GV23; bilateral BL2, GB4, TE23, Ex1 (Taiyang, ST1 and GB20; and left SP3, LU9, LU10 and HT8 for men, right for women have been selected for the verum acupuncture; for the sham acupuncture, points have been selected that do not coincide with a classical acupuncture point and that are located close to the verum points, except in the case of the rim of the eye. Ocular surface disease index, tear film breakup time, the Schirmer I test, medication quantification scale and general assessment of improvement will be used as outcome variables for evaluating the effectiveness of acupuncture. Safety will also be assessed at every visit. Primary and secondary outcomes will be assessed four weeks after screening. All statistical analyses will be performed using analysis of covariance. Discussion The results of this trial will be used as a basis for clarifying the efficacy of acupuncture for dry eye. Trial registration ClinicalTrials.gov NCT00969280.

  20. Treatment of periodontal disease during pregnancy: a randomized controlled trial.

    Science.gov (United States)

    Newnham, John P; Newnham, Ian A; Ball, Colleen M; Wright, Michelle; Pennell, Craig E; Swain, Jonathan; Doherty, Dorota A

    2009-12-01

    To investigate whether treating periodontal disease prevents preterm birth and other major complications of pregnancy. This single-center trial was conducted across six obstetric sites in metropolitan Perth, Western Australia. Pregnant women identified by history to be at risk (n=3,737) were examined for periodontal disease. Approximately 1,000 women with periodontal disease were allocated at random to receive periodontal treatment commencing around 20 weeks of gestation (n=542) or 6 weeks after the pregnancy was completed (controls; n=540). The treatment included mechanical removal of oral biofilms together with oral hygiene instruction and motivation at a minimum of three weekly visits, with further visits if required. There were no differences between the control and treatment groups in preterm birth (9.3% compared with 9.7%, odds ratio [OR] 1.05, 95% confidence interval [CI 0.7-1.58], P=.81), birth weight (3,450 compared with 3,410 g, P=.12), preeclampsia (4.1% compared with 3.4%, OR 0.82, 95% CI 0.44-1.56, P=.55), or other obstetric endpoints. There were four unexplained stillbirths in the control group and no pregnancy losses in the treated group (P=.12). Measures of fetal and neonatal well-being were similar in the two groups, including abnormalities in fetal heart rate recordings (P=.26), umbilical artery flow studies (P=.96), and umbilical artery blood gas values (P=.37). The periodontal treatment was highly successful in improving health of the gums (Pperiodontal disease during pregnancy in this population prevents preterm birth, fetal growth restriction, or preeclampsia. Periodontal treatment was not hazardous to the women or their pregnancies. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00133926. I.

  1. Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial.

    Science.gov (United States)

    Sharara-Chami, Rana; Lakissian, Zavi; Charafeddine, Lama; Milad, Nadine; El-Hout, Yaser

    2017-12-01

    There is no consensus on the most effective pain management for neonatal circumcision. We sought to compare different modalities. This is a double-blinded randomized controlled trial comparing 3 combination analgesics used during circumcision (EMLA + sucrose; EMLA + sucrose + dorsal penile nerve block [DPNB]; EMLA + sucrose + ring block [RB]) with the traditional topical analgesic cream EMLA alone. The trial was set in the normal nursery of a teaching hospital. The sample included 70 healthy male newborns, randomly assigned to intervention and control groups at a 2:1 ratio. Infants were videotaped (face and torso) during the procedure for assessment of pain by 2 blinded, independent reviewers. The primary outcome measure is the Neonatal Infant Pain Scale score. Secondary outcomes include heart rate, oxygen saturation, and crying time. Neonatal Infant Pain Scale scores were significantly lower in the intervention groups (EMLA + sucrose, mean [SD]: 3.1 [1.33]; EMLA + sucrose + DPNB: 3 [1.33]; EMLA + sucrose + RB: 2.45 [1.27]) compared with the control (5.5 [0.53]). Between-group analyses showed RB + EMLA + sucrose to be significantly more effective than EMLA + sucrose; EMLA + sucrose + DPNB ( P = .009 and P = .002, respectively). Interrater reliability was κ = 0.843. Significant increase in heart rate (139.27 [9.63] to 163 [13.23] beats per minute) and crying time (5.78 [6.4] to 45.37 [12.39] seconds) were noted in the EMLA group. During neonatal circumcision in boys, the most effective analgesia is RB combined with oral sucrose and EMLA cream. Copyright © 2017 by the American Academy of Pediatrics.

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

    DEFF Research Database (Denmark)

    Gluud, Christian; Nikolova, Dimitrinka

    2007-01-01

    The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study.......The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study....

  3. Regression Discontinuity and Randomized Controlled Trial Estimates: An Application to The Mycotic Ulcer Treatment Trials.

    Science.gov (United States)

    Oldenburg, Catherine E; Venkatesh Prajna, N; Krishnan, Tiruvengada; Rajaraman, Revathi; Srinivasan, Muthiah; Ray, Kathryn J; O'Brien, Kieran S; Glymour, M Maria; Porco, Travis C; Acharya, Nisha R; Rose-Nussbaumer, Jennifer; Lietman, Thomas M

    2018-08-01

    We compare results from regression discontinuity (RD) analysis to primary results of a randomized controlled trial (RCT) utilizing data from two contemporaneous RCTs for treatment of fungal corneal ulcers. Patients were enrolled in the Mycotic Ulcer Treatment Trials I and II (MUTT I & MUTT II) based on baseline visual acuity: patients with acuity ≤ 20/400 (logMAR 1.3) enrolled in MUTT I, and >20/400 in MUTT II. MUTT I investigated the effect of topical natamycin versus voriconazole on best spectacle-corrected visual acuity. MUTT II investigated the effect of topical voriconazole plus placebo versus topical voriconazole plus oral voriconazole. We compared the RD estimate (natamycin arm of MUTT I [N = 162] versus placebo arm of MUTT II [N = 54]) to the RCT estimate from MUTT I (topical natamycin [N = 162] versus topical voriconazole [N = 161]). In the RD, patients receiving natamycin had mean improvement of 4-lines of visual acuity at 3 months (logMAR -0.39, 95% CI: -0.61, -0.17) compared to topical voriconazole plus placebo, and 2-lines in the RCT (logMAR -0.18, 95% CI: -0.30, -0.05) compared to topical voriconazole. The RD and RCT estimates were similar, although the RD design overestimated effects compared to the RCT.

  4. Variability of pesticide residues in eggplant units collected from a field trial and marketplaces in Greece.

    Science.gov (United States)

    Prodhan, Mohammad Dalower Hossain; Papadakis, Emmanouil-Nikolaos; Papadopoulou-Mourkidou, Euphemia

    2018-04-01

    Variability of pesticide residues among food items is very important when assessing the risks and food safety for the consumers. Therefore, the present study was undertaken to estimate the unit-to-unit residue variability factors for eggplant. In total, 120 samples from a trial field and 142 samples from different marketplaces in Thessaloniki, Greece, were collected to estimate the variability of pesticide residues in eggplant units. They were extracted by the QuEChERS method and the residues were determined by LC-MS/MS. For the field samples, the unit-to-unit variability factors (VFs) obtained for cypermethrin and deltamethrin residues were 2.54 and 2.51, respectively. The mean residue levels of both pesticides were higher in the composite samples than in the individual samples. The average VFs for the marketplace samples was 3.89. The eggplant units exposed to pesticides were higher in residues than the non-exposed units. The variability factors obtained in the marketplace samples were higher than those in the samples collected from the field trial. A default VF value of 3 for field trials is appropriate for use when assessing the acute dietary intake but a VF for the marketplace samples should be reconsidered with a larger data. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

  5. A randomized controlled trial to promote volunteering in older adults.

    Science.gov (United States)

    Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne

    2014-12-01

    Volunteering is presumed to confer health benefits, but interventions to encourage older adults to volunteer are sparse. Therefore, a randomized controlled trial with 280 community-dwelling older German adults was conducted to test the effects of a theory-based social-cognitive intervention against a passive waiting-list control group and an active control intervention designed to motivate physical activity. Self-reports of weekly volunteering minutes were assessed at baseline (5 weeks before the intervention) as well as 2 and 6 weeks after the intervention. Participants in the treatment group increased their weekly volunteering minutes to a greater extent than participants in the control groups 6 weeks after the intervention. We conclude that a single, face-to-face group session can increase volunteering among older community-dwelling adults. However, the effects need some time to unfold because changes in volunteering were not apparent 2 weeks after the intervention. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

  6. The effectiveness of propolis on gingivitis: a randomized controlled trial.

    Science.gov (United States)

    Bretz, Walter A; Paulino, Niraldo; Nör, Jacques E; Moreira, Alexandre

    2014-12-01

    A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days -14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). The 38 persons who completed the study (age 13-22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period.

  7. Reiki for the treatment of fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack; Buchwald, Dedra

    2008-11-01

    Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. The study setting was private medical offices in the Seattle, Washington metropolitan area. The subjects were comprised 100 adults with fibromyalgia. Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.

  8. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

    International Nuclear Information System (INIS)

    Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing; Lee, J. Jack; Heymach, John V.; Swisher, Stephen G.; Welsh, James W.; Zhang, Jianjun; Lin, Steven H.; Gomez, Daniel R.

    2017-01-01

    Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

  9. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

    Energy Technology Data Exchange (ETDEWEB)

    Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lee, J. Jack [Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Heymach, John V. [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Swisher, Stephen G. [Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Welsh, James W. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Zhang, Jianjun [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lin, Steven H. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Gomez, Daniel R., E-mail: dgomez@mdanderson.org [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)

    2017-03-15

    Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

  10. Human EEG responses to controlled alterations of the Earth's magnetic field.

    Science.gov (United States)

    Sastre, Antonio; Graham, Charles; Cook, Mary R; Gerkovich, Mary M; Gailey, Paul

    2002-09-01

    Examine the effects of controlled changes in the Earth's magnetic field on electroencephalogram (EEG) and subjective report. Fifty volunteers were exposed double-blind to changes in field magnitude, angle of inclination, and angle of deviation. Volunteers were also exposed to magnetic field conditions found near the North and South Pole. EEG recorded over temporal and occipital sites was compared across 4s baseline, field exposure, and no-change control trials. No EEG spectral differences as a function of gender or recording site were found. Geomagnetic field alterations had no effect on total energy (0.5-42 Hz), energy within traditional EEG analysis bands, or on the 95% spectral edge. Most volunteers reported no sensations; others reported non-specific symptoms unrelated to type of field change. Three hypothesized field detection mechanisms were not supported: (1) mechanical reception through torque exerted on the ferromagnetic material magnetite; (2) movement-induced induction of an electric field in the body; and (3) enhanced sensitivity due to alterations in the rates of chemical reactions involving electron spin states. Humans have little ability to detect brief alterations in the geomagnetic field, even if these alteration are of a large magnitude.

  11. Exercise Training and Weight Gain in Obese Pregnant Women: A Randomized Controlled Trial (ETIP Trial.

    Directory of Open Access Journals (Sweden)

    Kirsti Krohn Garnæs

    2016-07-01

    .04. Systolic blood pressure was significantly lower in the exercise group (mean 120.4 mm Hg compared to the control group (mean 128.1 mm Hg, with a mean difference of -7.73 mm Hg (95% CI -13.23, -2.22; p = 0.006. No significant between-group differences were seen in diastolic blood pressure, blood measurements, skinfold thickness, or body composition in late pregnancy. In per protocol analyses, late pregnancy systolic blood pressure was 115.7 (95% CI 110.0, 121.5 mm Hg in the exercise group (significant between-group difference, p = 0.001, and diastolic blood pressure was 75.1 (95% CI 71.6, 78.7 mm Hg (significant between-group difference, p = 0.02. We had planned to recruit 150 women into the trial; hence, under-recruitment represents a major limitation of our results. Another limitation to our study was the low adherence to the exercise program, with only 50% of the women included in the intention-to-treat analysis adhering as described in the study protocol.In this trial we did not observe a reduction in GWG among overweight/obese women who received a supervised exercise training program during their pregnancy. The incidence of GDM in late pregnancy seemed to be lower in the women randomized to exercise training than in the women receiving standard maternity care only. Systolic blood pressure in late pregnancy was also apparently lower in the exercise group than in the control group. These results indicate that supervised exercise training might be beneficial as a part of standard pregnancy care for overweight/obese women.ClinicalTrials.gov NCT01243554.

  12. A randomized controlled trial of group Stepping Stones Triple P: a mixed-disability trial.

    Science.gov (United States)

    Roux, Gemma; Sofronoff, Kate; Sanders, Matthew

    2013-09-01

    Stepping Stones Triple P (SSTP) is a parenting program designed for families of a child with a disability. The current study involved a randomized controlled trial of Group Stepping Stones Triple P (GSSTP) for a mixed-disability group. Participants were 52 families of children diagnosed with an Autism Spectrum Disorder, Down syndrome, Cerebral Palsy, or an intellectual disability. The results demonstrated significant improvements in parent-reported child behavior, parenting styles, parental satisfaction, and conflict about parenting. Results among participants were similar despite children's differing impairments. The intervention effect was maintained at 6-month follow-up. The results indicate that GSSTP is a promising intervention for a mixed-disability group. Limitations of the study, along with areas for future research, are also discussed. © FPI, Inc.

  13. Systemic therapy for vulval Erosive Lichen Planus (the 'hELP' trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Simpson, Rosalind C; Murphy, Ruth; Bratton, Daniel J; Sydes, Matthew R; Wilkes, Sally; Nankervis, Helen; Dowey, Shelley; Thomas, Kim S

    2016-01-04

    Erosive lichen planus affecting the vulva (ELPV) is a relatively rare, chronic condition causing painful raw areas in the vulvovaginal region. Symptoms are pain and burning, which impact upon daily living. There is paucity of evidence regarding therapy. A 2012 Cochrane systematic review found no randomised controlled trials (RCTs) in this field. Topically administered corticosteroids are the accepted first-line therapy: however, there is uncertainty as to which second-line treatments to use. Several systemic agents have been clinically noted to show promise for ELPV refractory to topically administered corticosteroids but there is no RCT evidence to support these. The 'hELP' study is a RCT with an internal pilot phase designed to provide high-quality evidence. The objective is to test whether systemic therapy in addition to standard topical therapy is a beneficial second-line treatment for ELPV. Adjunctive systemic therapies used are hydroxychloroquine, methotrexate, mycophenolate mofetil and prednisolone. Topical therapy plus a short course of prednisolone given orally is considered the comparator intervention. The trial is a four-armed, open-label, pragmatic RCT which uses a blinded independent clinical assessor. To provide 80 % power for each comparison, 96 participants are required in total. The pilot phase aims to recruit 40 participants. The primary clinical outcome is the proportion of patients achieving treatment success at 6 months. 'Success' is defined by a composite measure of Patient Global Assessment score of 0 or 1 on a 4-point scale plus improvement from baseline on clinical photographs scored by a clinician blinded to treatment allocation. Secondary clinical outcomes include 6-month assessment of: (1) Reduction in pain/soreness; (2) Global assessment of disease; (3) Response at other affected mucosal sites; (4) Hospital Anxiety and Depression Scale scores; (5) Sexual function; (6) Health-related quality of life using 'Short Form 36' and 'Skindex

  14. Acupuncture as pain relief during delivery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    BACKGROUND: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. METHODS: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... with the intention-to-treat principle. RESULTS: Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin...

  15. [Critical of the additive model of the randomized controlled trial].

    Science.gov (United States)

    Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine

    2008-01-01

    Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect.

  16. Neighborhood effects in a behavioral randomized controlled trial.

    Science.gov (United States)

    Pruitt, Sandi L; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

    2014-11-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient's CRC test use. This potentially important spatially-varying covariate has not previously been considered in a RCT. Our results suggest that future RCTs of health behavior interventions should assess potential social interactions between participants, which may cause intervention arm contamination and may bias effect size estimation. Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. Synthesis of results of randomized controlled trials of contrast media

    International Nuclear Information System (INIS)

    Kinnison, M.L.; Powe, N.R.; Steinberg, E.P.

    1988-01-01

    The authors review 100 randomized controlled trials (RCTs) that examine the safety or efficacy of new low-osmolality contrast media (LOM) and focus on the 43 RCTs judged to be of the highest quality. These RCTs showed no consistent differences in nephrotoxicity between high- and low-osmolality contrast media. Certain cardiovascular parameters were altered less with low-osmolality agents during intracardiac injection, but the clinical significance of these differences in unclear. Heat and pain sensations occurred less often with low-osmolality contrast media. No differences were noted in the incidence of nausea, vomiting, urticaria, or bronchospasm. Even with numerous RCTs comparing these media, physicians still must make economically significant choices about contrast media without sufficient data about their relative safety

  18. Exercise and manual physiotherapy arthritis research trial (EMPART: a multicentre randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Connell Paul

    2009-01-01

    Full Text Available Abstract Background Osteoarthritis (OA of the hip is a major cause of functional disability and reduced quality of life. Management options aim to reduce pain and improve or maintain physical functioning. Current evidence indicates that therapeutic exercise has a beneficial but short-term effect on pain and disability, with poor long-term benefit. The optimal content, duration and type of exercise are yet to be ascertained. There has been little scientific investigation into the effectiveness of manual therapy in hip OA. Only one randomized controlled trial (RCT found greater improvements in patient-perceived improvement and physical function with manual therapy, compared to exercise therapy. Methods and design An assessor-blind multicentre RCT will be undertaken to compare the effect of a combination of manual therapy and exercise therapy, exercise therapy only, and a waiting-list control on physical function in hip OA. One hundred and fifty people with a diagnosis of hip OA will be recruited and randomly allocated to one of 3 groups: exercise therapy, exercise therapy with manual therapy and a waiting-list control. Subjects in the intervention groups will attend physiotherapy for 6–8 sessions over 8 weeks. Those in the control group will remain on the waiting list until after this time and will then be re-randomised to one of the two intervention groups. Outcome measures will include physical function (WOMAC, pain severity (numerical rating scale, patient perceived change (7-point Likert scale, quality of life (SF-36, mood (hospital anxiety and depression scale, patient satisfaction, physical activity (IPAQ and physical measures of range of motion, 50-foot walk and repeated sit-to stand tests. Discussion This RCT will compare the effectiveness of the addition of manual therapy to exercise therapy to exercise therapy only and a waiting-list control in hip OA. A high quality methodology will be used in keeping with CONSORT guidelines. The

  19. INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST: a randomized controlled trial of percutaneous vertebroplasty

    Directory of Open Access Journals (Sweden)

    Stout Lydia

    2007-12-01

    -primary outcomes are the modified Roland score and pain numerical rating scale at 1 month. Discussion Although extensively utilized throughout North America for palliation of pain, vertebroplasty still has not undergone rigorous study. The study outlined above represents the first randomized, controlled study that can account for a placebo effect in the setting of vertebroplasty. Trial Registration Current Controlled Trials ISRCTN81871888

  20. A Randomized Controlled Trial Determining Variances in Ostomy Skin Conditions and the Economic Impact (ADVOCATE Trial).

    Science.gov (United States)

    Colwell, Janice C; Pittman, Joyce; Raizman, Rose; Salvadalena, Ginger

    To compare ostomy-related costs and incidence of peristomal skin complications (PSCs) for ceramide-infused ostomy skin barriers and control skin barriers. The ADVOCATE trial is a multi-centered randomized controlled trial, and double-blinded international study with an adaptive design. The sample comprised 153 adults from 25 sites from the United States, Canada, and Europe. Participants were seen in hospital and outpatient care settings. Data were collected by investigators at each site during face-to-face visits and during telephone check-in calls between visits. Cost of care data were collected using a questionnaire developed specifically for the study. The peristomal skin was assessed using the Ostomy Skin Tool. Health-related quality of life was measured using the SF-12v2. Patient-reported outcomes were collected using a patient-centered study-specific questionnaire. Cost of care was analyzed via analysis of covariance comparing total cost of care for 12 weeks between the 2 groups. The incidence of PSC was analyzed via Barnard's exact test comparing the incidence of PSCs between the control and treatment groups. Tertiary outcomes were exploratory in nature and not statistically powered. Use of the ceramide-infused barrier significantly reduced stoma-related cost of care over a 12-week period, resulting in a $36.46 decrease in cost (14% relative decrease). The adjusted average costs were $223.73 in the treatment group and $260.19 in the control group (P = .017). The overall incidence of PSCs in the study was 47.7%; PSC incidence was 40.5% for the treatment group versus 55.4% for controls (P = .069, 95% confidence interval of the difference: -1.2 to 30.4). Significantly more participants using the ceramide-infused skin barrier were "very satisfied" with barrier performance (75% vs 55%; P = .033), prevention of leakage (63% vs 38%; P < .01), and prevention of itching (53% vs 31%; P = .016). General postoperative improvement in health-related quality of life was

  1. A Randomized, Double-Blind Placebo Controlled Trial of Balapiravir, a Polymerase Inhibitor, in Adult Dengue Patients

    Science.gov (United States)

    Nguyen, Nguyet Minh; Tran, Chau Nguyen Bich; Phung, Lam Khanh; Duong, Kien Thi Hue; Huynh, Huy le Anh; Farrar, Jeremy; Nguyen, Quyen Than Ha; Tran, Hien Tinh; Nguyen, Chau Van Vinh; Merson, Laura; Hoang, Long Truong; Hibberd, Martin L.; Aw, Pauline P. K.; Wilm, Andreas; Nagarajan, Niranjan; Nguyen, Dung Thi; Pham, Mai Phuong; Nguyen, Truong Thanh; Javanbakht, Hassan; Klumpp, Klaus; Hammond, Janet; Petric, Rosemary; Wolbers, Marcel; Nguyen, Chinh Tran; Simmons, Cameron P.

    2013-01-01

    Background. Dengue is the most common arboviral infection of humans. There are currently no specific treatments for dengue. Balapiravir is a prodrug of a nucleoside analogue (called R1479) and an inhibitor of hepatitis C virus replication in vivo. Methods. We conducted in vitro experiments to determine the potency of balapiravir against dengue viruses and then an exploratory, dose-escalating, randomized placebo-controlled trial in adult male patients with dengue with treatment. Conclusions. Although this trial, the first of its kind in dengue, does not support balapiravir as a candidate drug, it does establish a framework for antiviral treatment trials in dengue and provides the field with a clinically evaluated benchmark molecule. Clinical Trials Registration. NCT01096576. PMID:22807519

  2. Acupuncture Improves Peri-menopausal Insomnia: A Randomized Controlled Trial.

    Science.gov (United States)

    Fu, Cong; Zhao, Na; Liu, Zhen; Yuan, Lu-Hua; Xie, Chen; Yang, Wen-Jia; Yu, Xin-Tong; Yu, Huan; Chen, Yun-Fei

    2017-11-01

    To evaluate the short-term efficacy of acupuncture for the treatment of peri-menopausal insomnia (PMI). Design: A randomized, participant-blind, placebo-controlled trial consisted of the acupuncture group (n = 38) and placebo-acupuncture group (n = 38). Setting: A tertiary teaching and general hospital. Participants: 76 peri-menopausal women with insomnia disorder based on the International Classification of Sleep Disorders, Third Edition. Interventions: A 10-session of acupuncture at bilateral Shenshu (BL 23) and Ganshu (BL 18) with unilateral Qimen (LR 14) and Jingmen (GB 25) or Streitberger needles at the same acupoints was performed for over 3 weeks. Measurements: Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with over-night polysomnography (PSG) exam were completed at baseline and post-treatment. After the treatments, the decrease from baseline in PSQI score was 8.03 points in acupuncture group and 1.29 points in placebo-acupuncture group. The change from baseline in ISI score was 11.35 points in acupuncture group and 2.87 points in placebo-acupuncture group. In PSG data, acupuncture significantly improved the sleep efficiency and total sleep time, associated with less wake after sleep onset and lower percent stage 1 after the treatment. No significant differences from baseline to post-treatment were found in placebo-acupuncture group. Acupuncture can contribute to a clinically relevant improvement in the short-term treatment of PMI, both subjectively and objectively. Acupuncture for peri-menopause insomnia: a randomized controlled trial, http://www.chictr.org.cn/showproj.aspx?proj=12118 ChiCTR-IPR-15007199, China. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

  3. Testing the activitystat hypothesis: a randomised controlled trial protocol.

    Science.gov (United States)

    Gomersall, Sjaan; Maher, Carol; Norton, Kevin; Dollman, Jim; Tomkinson, Grant; Esterman, Adrian; English, Coralie; Lewis, Nicole; Olds, Tim

    2012-10-08

    The activitystat hypothesis proposes that when physical activity or energy expenditure is increased or decreased in one domain, there will be a compensatory change in another domain to maintain an overall, stable level of physical activity or energy expenditure. To date, there has been no experimental study primarily designed to test the activitystat hypothesis in adults. The aim of this trial is to determine the effect of two different imposed exercise loads on total daily energy expenditure and physical activity levels. This study will be a randomised, multi-arm, parallel controlled trial. Insufficiently active adults (as determined by the Active Australia survey) aged 18-60 years old will be recruited for this study (n=146). Participants must also satisfy the Sports Medicine Australia Pre-Exercise Screening System and must weigh less than 150 kg. Participants will be randomly assigned to one of three groups using a computer-generated allocation sequence. Participants in the Moderate exercise group will receive an additional 150 minutes of moderate to vigorous physical activity per week for six weeks, and those in the Extensive exercise group will receive an additional 300 minutes of moderate to vigorous physical activity per week for six weeks. Exercise targets will be accumulated through both group and individual exercise sessions monitored by heart rate telemetry. Control participants will not be given any instructions regarding lifestyle. The primary outcome measures are activity energy expenditure (doubly labeled water) and physical activity (accelerometry). Secondary measures will include resting metabolic rate via indirect calorimetry, use of time, maximal oxygen consumption and several anthropometric and physiological measures. Outcome measures will be conducted at baseline (zero weeks), mid- and end-intervention (three and six weeks) with three (12 weeks) and six month (24 week) follow-up. All assessors will be blinded to group allocation. This protocol

  4. A randomized controlled trial of storytelling as a communication tool.

    Directory of Open Access Journals (Sweden)

    Lisa Hartling

    : Current Controlled Trials, ISRCTN39642997 (http://www.controlled-trials.com/ISRCTN39642997.

  5. Effects of the AMPA antagonist ZK 200775 on visual function: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Richard Bergholz

    Full Text Available BACKGROUND: ZK 200775 is an antagonist at the alpha-Amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA receptor and had earned attention as a possible neuroprotective agent in cerebral ischemia. Probands receiving the agent within phase I trials reported on an alteration of visual perception. In this trial, the effects of ZK 200775 on the visual system were analyzed in detail. METHODOLOGY: In a randomised controlled trial we examined eyes and vision before and after the intravenous administration of two different doses of ZK 200775 and placebo. There were 3 groups of 6 probands each: Group 1 recieved 0.03 mg/kg/h, group 2 0.75 mg/kg/h of ZK 200775, the control group received 0.9% sodium chloride solution. Probands were healthy males aged between 57 and 69 years. The following methods were applied: clinical examination, visual acuity, ophthalmoscopy, colour vision, rod absolute threshold, central visual field, pattern-reversal visual evoked potentials (pVEP, ON-OFF and full-field electroretinogram (ERG. PRINCIPAL FINDINGS: No effect of ZK 200775 was seen on eye position or motility, stereopsis, pupillary function or central visual field testing. Visual acuity and dark vision deteriorated significantly in both treated groups. Color vision was most remarkably impaired. The dark-adapted ERG revealed a reduction of oscillatory potentials (OP and partly of the a- and b-wave, furthermore an alteration of b-wave morphology and an insignificantly elevated b/a-ratio. Cone-ERG modalities showed decreased amplitudes and delayed implicit times. In the ON-OFF ERG the ON-answer amplitudes increased whereas the peak times of the OFF-answer were reduced. The pattern VEP exhibited lower amplitudes and prolonged peak times. CONCLUSIONS: The AMPA receptor blockade led to a strong impairment of typical OFF-pathway functions like color vision and the cone ERG. On the other hand the ON-pathway as measured by dark vision and the scotopic ERG was affected as well

  6. The Sandia/Arzamas-16 Magazine-to-Magazine Remote Monitoring Field Trial Evaluation

    International Nuclear Information System (INIS)

    Barkanov, Boris; Blagin, Sergei; Croessmann, Dennis; Damico, Joe; Ehle, Steve; Nilsen, Curt

    1999-01-01

    Sandia National Laboratories and the Russian Federal Nuclear Center-All Russian Research Institute for Experimental Physics (VNIIEF) (also known as Arzamas-16) are collaborating on ways to assure the highest standards of safety, security, and international accountability of fissile material. For these collaborations, sensors and information technologies have been identified as important in reaching these standards in a cost-effective manner. Specifically, Sandia and VNIIEF have established a series of remote monitoring field trials to provide a mechanism for joint research and development on storage monitoring systems. These efforts consist of the ''Container-to-Container'', ''Magazine-to-Magazine'', and ''Facility-to-Facility'' field trials. This paper will describe the evaluation exercise Sandia and VNIIEF conducted on the Magazine-to-Magazine systems. Topics covered will include a description of the evaluation philosophy, how the various sensors and system features were tested, evaluation results, and lessons learned

  7. Behavioral neurocardiac training in hypertension: a randomized, controlled trial.

    Science.gov (United States)

    Nolan, Robert P; Floras, John S; Harvey, Paula J; Kamath, Markad V; Picton, Peter E; Chessex, Caroline; Hiscock, Natalie; Powell, Jonathan; Catt, Michael; Hendrickx, Hilde; Talbot, Duncan; Chen, Maggie H

    2010-04-01

    It is not established whether behavioral interventions add benefit to pharmacological therapy for hypertension. We hypothesized that behavioral neurocardiac training (BNT) with heart rate variability biofeedback would reduce blood pressure further by modifying vagal heart rate modulation during reactivity and recovery from standardized cognitive tasks ("mental stress"). This randomized, controlled trial enrolled 65 patients with uncomplicated hypertension to BNT or active control (autogenic relaxation), with six 1-hour sessions over 2 months with home practice. Outcomes were analyzed with linear mixed models that adjusted for antihypertensive drugs. BNT reduced daytime and 24-hour systolic blood pressures (-2.4+/-0.9 mm Hg, P=0.009, and -2.1+/-0.9 mm Hg, P=0.03, respectively) and pulse pressures (-1.7+/-0.6 mm Hg, P=0.004, and -1.4+/-0.6 mm Hg, P=0.02, respectively). No effect was observed for controls (P>0.10 for all indices). BNT also increased RR-high-frequency power (0.15 to 0.40 Hz; P=0.01) and RR interval (P0.10). In contrast to relaxation therapy, BNT with heart rate variability biofeedback modestly lowers ambulatory blood pressure during wakefulness, and it augments tonic vagal heart rate modulation. It is unknown whether efficacy of this treatment can be improved with biofeedback of baroreflex gain. BNT, alone or as an adjunct to drug therapy, may represent a promising new intervention for hypertension.

  8. Infant Sleep After Immunization: Randomized Controlled Trial of Prophylactic Acetaminophen

    Science.gov (United States)

    Gay, Caryl L.; Lynch, Mary; Lee, Kathryn A.

    2011-01-01

    OBJECTIVE: To determine the effects of acetaminophen and axillary temperature responses on infant sleep duration after immunization. METHODS: We conducted a prospective, randomized controlled trial to compare the sleep of 70 infants monitored by using ankle actigraphy for 24 hours before and after their first immunization series at ∼2 months of age. Mothers of infants in the control group received standard care instructions from their infants' health care provider, and mothers of infants in the intervention group were provided with predosed acetaminophen and instructed to administer a dose 30 minutes before the scheduled immunization and every 4 hours thereafter, for a total of 5 doses. Infant age and birth weight and immunization factors, such as acetaminophen use and timing of administration, were evaluated for changes in infant sleep times after immunization. RESULTS: Sleep duration in the first 24 hours after immunization was increased, particularly for infants who received their immunizations after 1:30 pm and for those who experienced elevated temperatures in response to the vaccines. Infants who received acetaminophen at or after immunization had smaller increases in sleep duration than did infants who did not. However, acetaminophen use was not a significant predictor of sleep duration when other factors were controlled. CONCLUSIONS: If further research confirms the relationship between time of day of vaccine administration, increased sleep duration after immunization, and antibody responses, then our findings suggest that afternoon immunizations should be recommended to facilitate increased sleep in the 24 hours after immunization, regardless of acetaminophen administration. PMID:22123869

  9. Antidepressant Controlled Trial For Negative Symptoms In Schizophrenia (ACTIONS): a double-blind, placebo-controlled, randomised clinical trial.

    Science.gov (United States)

    Barnes, Thomas R E; Leeson, Verity C; Paton, Carol; Costelloe, Céire; Simon, Judit; Kiss, Noemi; Osborn, David; Killaspy, Helen; Craig, Tom K J; Lewis, Shôn; Keown, Patrick; Ismail, Shajahan; Crawford, Mike; Baldwin, David; Lewis, Glyn; Geddes, John; Kumar, Manoj; Pathak, Rudresh; Taylor, Simon

    2016-04-01

    Negative symptoms of schizophrenia represent deficiencies in emotional responsiveness, motivation, socialisation, speech and movement. When persistent, they are held to account for much of the poor functional outcomes associated with schizophrenia. There are currently no approved pharmacological treatments. While the available evidence suggests that a combination of antipsychotic and antidepressant medication may be effective in treating negative symptoms, it is too limited to allow any firm conclusions. To establish the clinical effectiveness and cost-effectiveness of augmentation of antipsychotic medication with the antidepressant citalopram for the management of negative symptoms in schizophrenia. A multicentre, double-blind, individually randomised, placebo-controlled trial with 12-month follow-up. Adult psychiatric services, treating people with schizophrenia. Inpatients or outpatients with schizophrenia, on continuing, stable antipsychotic medication, with persistent negative symptoms at a criterion level of severity. Eligible participants were randomised 1 : 1 to treatment with either placebo (one capsule) or 20 mg of citalopram per day for 48 weeks, with the clinical option at 4 weeks to increase the daily dosage to 40 mg of citalopram or two placebo capsules for the remainder of the study. The primary outcomes were quality of life measured at 12 and 48 weeks assessed using the Heinrich's Quality of Life Scale, and negative symptoms at 12 weeks measured on the negative symptom subscale of the Positive and Negative Syndrome Scale. No therapeutic benefit in terms of improvement in quality of life or negative symptoms was detected for citalopram over 12 weeks or at 48 weeks, but secondary analysis suggested modest improvement in the negative symptom domain, avolition/amotivation, at 12 weeks (mean difference -1.3, 95% confidence interval -2.5 to -0.09). There were no statistically significant differences between the two treatment arms over 48-week

  10. Evaluation of Supercritical Extracts of Algae as Biostimulants of Plant Growth in Field Trials

    OpenAIRE

    Michalak, Izabela; Chojnacka, Katarzyna; Dmytryk, Agnieszka; Wilk, Rados?aw; Gramza, Mateusz; R?j, Edward

    2016-01-01

    The aim of the field trials was to determine the influence of supercritical algal extracts on the growth and development of winter wheat (variety Akteur). As a raw material for the supercritical fluid extraction (SFE), the biomass of microalga Spirulina plantensis, brown seaweed – Ascophyllum nodosum and Baltic green macroalgae was used. Forthial and Asahi SL constituted the reference products. It was found that the tested biostimulants did not influence statistically significantly the plant...

  11. Empowerment Program for People With Prediabetes: A Randomized Controlled Trial.

    Science.gov (United States)

    Chen, Mei-Fang; Hung, Shu-Ling; Chen, Shu-Lin

    2017-04-01

    Practicing a health-promoting lifestyle is believed to be effective for delaying or preventing the onset of diabetes. However, although empowerment interventions have proven effective for encouraging the adoption of a health-promoting lifestyle in people with diabetes, these interventions are rarely promoted to people with prediabetes. The aims of this study were to develop an empowerment program for people with prediabetes and to examine its efficacy in terms of the adoption of a health-promoting lifestyle and improvements in blood sugar, body mass index, and self-efficacy. A randomized controlled trial was conducted between May and December 2013. A convenience sample of people with a fasting blood sugar level of 100-125 mg/dl during the previous 3 months was recruited from the health examination center of a hospital in Kaohsiung, Taiwan. Participants were assigned to either the experimental group or the control group using block randomization with a block size of 8. The experimental group (n = 38) participated in a 4-month empowerment program (the ABC empowerment program), which encouraged participants to practice a health-promoting lifestyle in three phases: awareness raising, behavior building, and results checking. The control group (n = 40) received routine clinical care. Statistical analyses included descriptive statistics, independent t test, paired t test, and generalized estimated equations. After controlling for the differences at baseline and considering the interaction between group and time from baseline to 1 week and 3 months after completing the intervention, the generalized estimating equation showed significantly larger improvements in a health-promoting lifestyle, blood sugar, and self-efficacy in the experimental group than in the control group (p empowerment program was shown to have short-term, positive effects on behavioral, physical, and psychosocial outcomes in a Taiwan population with prediabetes. The results of this study provide a useful

  12. Randomised controlled trial of reflexology for menopausal symptoms.

    Science.gov (United States)

    Williamson, Jan; White, Adrian; Hart, Anna; Ernst, Edzard

    2002-09-01

    Clinical experience suggests that reflexology may have beneficial effects on the symptoms occurring in menopausal women, particularly psychological symptoms. This study aims to examine that effect rigorously. Randomised controlled trial with two parallel arms. School of Complementary Health in Exeter, Devon, UK. Seventy-six women, aged between 45 and 60 years, reporting menopausal symptoms. Women were randomised to receive nine sessions of either reflexology or nonspecific foot massage (control) by four qualified reflexologists given over a period of 19 weeks. The Women's Health Questionnaire (WHQ), the primary measures being the subscores for anxiety and depression. Severity (visual analogue scale, VAS) and frequency of flushes and night sweats. Mean (SD) scores for anxiety fell from 0.43 (0.29) to 0.22 (0.25) in the reflexology group and from 0.37 (0.27) to 0.27 (0.29) in the control group over the course of treatment. Mean (SD) scores for depression fell from 0.37 (0.25) to 0.20 (0.24) in the reflexology group and from 0.36 (0.23) to 0.20 (0.21) in the control (foot massage) group over the same period. For both scores there was strong evidence of a time effect (P 0.2). Similar changes were found for severity of hot flushes and night sweats. In the control group, 14/37 believed they had not received true reflexology. Foot reflexology was not shown to be more effective than non-specific foot massage in the treatment of psychological symptoms occurring during the menopause.

  13. Research note : field control of asphalt concrete paving mixtures.

    Science.gov (United States)

    1995-01-01

    The goal of this study was to develop information and evaluate new methods for controlling quality of the AC mixture in the mat. Specifically, this research project evaluated a gyratory compactor in the field laboratory to determine mix quality. Spec...

  14. Improvement of RFX performances by field and impurity control

    International Nuclear Information System (INIS)

    Buffa, A.; Gnesotto, F.

    1995-01-01

    The Reverse Field Pinch experiment RFX has been operated since 1992 with the principal objective of extending the knowledge of RFP confinement to larger dimensions and higher plasma currents. Experiments have been run between 500 and 900 kA; confinement parameters are mainly determined by magnetic field quality and plasma density behavior. Significant improvements were obtained by feedback controlling the poloidal field configuration and by reducing the impurities produced by plasma-wall interactions

  15. Technical results of Y-12/IAEA field trial of remote monitoring system

    International Nuclear Information System (INIS)

    Corbell, B.H.; Whitaker, J.M.; Welch, J.

    1997-01-01

    A Remote Monitoring System (RMS) field trial has been conducted with the International Atomic Energy Agency (IAEA) on highly enriched uranium materials in a vault at the Oak Ridge Y-12 Plant. The RMS included a variety of Sandia, Oak Ridge, and Aquila sensor technologies which provide containment seals, video monitoring, radiation asset measurements, and container identification data to the on-site DAS (Data Acquisition System) by way of radio-frequency and Echelon LonWorks networks. The accumulated safeguards information was transmitted to the IAEA via satellite (COMSAT/RSI) and international telephone lines. The technologies tested in the remote monitoring environment are the RadCouple, RadSiP, and SmartShelf sensors from the ORSENS (Oak Ridge Sensors for Enhancing Nuclear Safeguards) technologies; the AIMS (Authenticated Item Monitoring System) motion sensor (AMS), AIMS fiber-optic seal (AFOS), ICAM (Image Compression and Authentication Module) video surveillance system, DAS (Data Acquisition System), and DIRS (Data and Image Review Station) from Sandia; and the AssetLAN identification tag, VACOSS-S seal, and Gemini digital surveillance system from Aquila. The field trial was conducted from October 1996 through May 1997. Tests were conducted during the monthly IAEA Interim Inventory Verification (IIV) inspections for evaluation of the equipment. Experience gained through the field trials will allow the technologies to be applied to various monitoring scenarios

  16. Dynamic Artificial Potential Fields for Autonomous Camera Control

    DEFF Research Database (Denmark)

    Burelli, Paolo; Jhala, Arnav Harish

    2009-01-01

    the implementation and evaluation of Artificial Potential Fields for automatic camera placement. We first describe the re- casting of the frame composition problem as a solution to a two particles suspended in an Artificial Potential Field. We demonstrate the application of this technique to control both camera...

  17. NMR magnetic field controller for pulsed nuclear magnetic resonance experiments

    International Nuclear Information System (INIS)

    Scheler, G.; Anacker, M.

    1975-01-01

    A nuclear magnetic resonance controller for magnetic fields, which can also be used for pulsed NMR investigations, is described. A longtime stability of 10 -7 is achieved. The control signal is generated by a modified time sharing circuit with resonance at the first side band of the 2 H signal. An exact calibration of the magnetic field is achieved by the variation of the H 1 - or of the time-sharing frequency. (author)

  18. Field Efficiency Trial of 72% Streptomycin against Konjac Bacterial Soft Rot

    Institute of Scientific and Technical Information of China (English)

    Huang; Yongsheng; Li; Xiaojun; Zhu; Shijin; Ma; Yongsheng; Wang; Li

    2014-01-01

    72% Streptomycin soluble powder was used to control konjac bacterial soft rot in the study. The control efficiency and yield of different treatments were investigated,and the benefit was analyzed. The control scheme against konjac bacterial soft rot was as follows: spraying 72% atreptomycinon twice on rotation fields after all the seedlings were strong and uniform,or irrigating roots with 72% atreptomycinon once and spraying twice on continuous cropping fields.

  19. What can qualitative research do for randomised controlled trials? A systematic mapping review

    Science.gov (United States)

    O'Cathain, A; Thomas, K J; Drabble, S J; Rudolph, A; Hewison, J

    2013-01-01

    Objective To develop an empirically based framework of the aspects of randomised controlled trials addressed by qualitative research. Design Systematic mapping review of qualitative research undertaken with randomised controlled trials and published in peer-reviewed journals. Data sources MEDLINE, PreMEDLINE, EMBASE, the Cochrane Library, Health Technology Assessment, PsycINFO, CINAHL, British Nursing Index, Social Sciences Citation Index and ASSIA. Eligibility criteria Articles reporting qualitative research undertaken with trials published between 2008 and September 2010; health research, reported in English. Results 296 articles met the inclusion criteria. Articles focused on 22 aspects of the trial within five broad categories. Some articles focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356); the design, process and conduct of the trial (15%, 54/356); the outcomes of the trial (1%, 5/356); the measures used in the trial (3%, 10/356); and the target condition for the trial (9%, 33/356). A minority of the qualitative research was undertaken at the pretrial stage (28%, 82/296). The value of the qualitative research to the trial itself was not always made explicit within the articles. The potential value included optimising the intervention and trial conduct, facilitating interpretation of the trial findings, helping trialists to be sensitive to the human beings involved in trials, and saving money by steering researchers towards interventions more likely to be effective in future trials. Conclusions A large amount of qualitative research undertaken with specific trials has been published, addressing a wide range of aspects of trials, with the potential to improve the endeavour of generating evidence of effectiveness of health interventions. Researchers can increase the impact of this work on trials by undertaking more of it at the pretrial stage and being explicit

  20. Process control analysis of IMRT QA: implications for clinical trials

    International Nuclear Information System (INIS)

    Pawlicki, Todd; Rice, Roger K; Yoo, Sua; Court, Laurence E; McMillan, Sharon K; Russell, J Donald; Pacyniak, John M; Woo, Milton K; Basran, Parminder S; Boyer, Arthur L; Bonilla, Claribel

    2008-01-01

    four states with none of the processes in the ideal state. Control charts may be used for IMRT QA in clinical trials to categorize process performance, minimize protocol variation and guide process improvements. For the duration of an institution's participation in a protocol, updated control charts can be periodically sent to the protocol QA center to document continued process performance to protocol specifications

  1. Skin treatment with bepanthen cream versus no cream during radiotherapy. A randomized controlled trial

    International Nuclear Information System (INIS)

    Loekkevik, E.; Skovlund, E.; Oslo Univ.; Reitan, J.B.; Norwegian Radiation Protection Authority, Oslo; Hannisdal, E.; Tanum, G.

    1996-01-01

    In several radiotherapy departments, dexpanthenol cream (Bepanthen 'Roche') has been used extensively to ameliorate acute radiotherapy skin reactions. The evidence base for this practice is obscure as no randomized trials have been performed. In the present clinical prospective study of 86 patients we have compared Bepanthen cream with no topical ointment at all. The cream was applied on randomly selected parts of treatment fields in laryngeal and breast cancer patients, and so each patient acted as his own control. Seven patients were widthdrawn from analysis. Scoring of skin reactions in 16 laryngeal and 63 breast cancer patients was performed without knowledge of which are that had been given cream or not. Endpoints were a modified skin reaction grading according to EORTC/RTOG, and itching/apin in treated fields. The study did not indicate any clinically important benefits of using Bepanthen cream for ameliorating radiogenic skin reactions under the conditions applied. (orig.)

  2. Naturopathic care for anxiety: a randomized controlled trial ISRCTN78958974.

    Directory of Open Access Journals (Sweden)

    Kieran Cooley

    Full Text Available BACKGROUND: Anxiety is a serious personal health condition and represents a substantial burden to overall quality of life. Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial. METHODS: Employees with moderate to severe anxiety of longer than 6 weeks duration were randomized based on age and gender to receive naturopathic care (NC (n = 41 or standardized psychotherapy intervention (PT (n = 40 over a period of 12 weeks. Blinding of investigators and participants during randomization and allocation was maintained. Participants in the NC group received dietary counseling, deep breathing relaxation techniques, a standard multi-vitamin, and the herbal medicine, ashwagandha (Withania somnifera (300 mg b.i.d. standardized to 1.5% with anolides, prepared from root. The PT intervention received psychotherapy, and matched deep breathing relaxation techniques, and placebo. The primary outcome measure was the Beck Anxiety Inventory (BAI and secondary outcome measures included the Short Form 36 (SF-36, Fatigue Symptom Inventory (FSI, and Measure Yourself Medical Outcomes Profile (MY-MOP to measure anxiety, mental health, and quality of life respectively. Participants were blinded to the placebo-controlled intervention. RESULTS: Seventy-five participants (93% were followed for 8 or more weeks on the trial. Final BAI scores decreased by 56.5% (p<0.0001 in the NC group and 30.5% (p<0.0001 in the PT group. BAI group scores were significantly decreased in the NC group compared to PT group (p = 0.003. Significant differences between groups were also observed in mental health, concentration, fatigue, social functioning, vitality, and overall quality of life with the NC group exhibiting greater clinical benefit. No serious adverse reactions

  3. Balancing ballistic protection against physiological strain: evidence from laboratory and field trials.

    Science.gov (United States)

    Taylor, Nigel A S; Burdon, Catriona A; van den Heuvel, Anne M J; Fogarty, Alison L; Notley, Sean R; Hunt, Andrew P; Billing, Daniel C; Drain, Jace R; Silk, Aaron J; Patterson, Mark J; Peoples, Gregory E

    2016-02-01

    This project was based on the premise that decisions concerning the ballistic protection provided to defence personnel should derive from an evaluation of the balance between protection level and its impact on physiological function, mobility, and operational capability. Civilians and soldiers participated in laboratory- and field-based studies in which ensembles providing five levels of ballistic protection were evaluated, each with progressive increases in protection, mass (3.4-11.0 kg), and surface-area coverage (0.25-0.52 m(2)). Physiological trials were conducted on volunteers (N = 8) in a laboratory, under hot-dry conditions simulating an urban patrol: walking at 4 km·h(-1) (90 min) and 6 km·h(-1) (30 min or to fatigue). Field-based trials were used to evaluate tactical battlefield movements (mobility) of soldiers (N = 31) under tropical conditions, and across functional tests of power, speed, agility, endurance, and balance. Finally, trials were conducted at a jungle training centre, with soldiers (N = 32) patrolling under tropical conditions (averaging 5 h). In the laboratory, work tolerance was reduced as protection increased, with deep-body temperature climbing relentlessly. However, the protective ensembles could be grouped into two equally stressful categories, each providing a different level of ballistic protection. This outcome was supported during the mobility trials, with the greatest performance decrement evident during fire and movement simulations, as the ensemble mass was increased (-2.12%·kg(-1)). The jungle patrol trials similarly supported this outcome. Therefore, although ballistic protection does increase physiological strain, this research has provided a basis on which to determine how that strain can be balanced against the mission-specific level of required personal protection.

  4. Novel electronic refreshers for cardiopulmonary resuscitation: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Magura Stephen

    2012-11-01

    Full Text Available Abstract Background Currently the American Red Cross requires that individuals renew their cardiopulmonary resuscitation (CPR certification annually; this often requires a 4- to 8-hour refresher course. Those trained in CPR often show a decrease in essential knowledge and skills within just a few months after training. New electronic means of communication have expanded the possibilities for delivering CPR refreshers to members of the general public who receive CPR training. The study’s purpose was to determine the efficacy of three novel CPR refreshers - online website, e-mail and text messaging – for improving three outcomes of CPR training - skill retention, confidence for using CPR and intention to use CPR. These three refreshers may be considered “novel” in that they are not typically used to refresh CPR knowledge and skills. Methods The study conducted two randomized clinical trials of the novel CPR refreshers. A mailed brochure was a traditional, passive refresher format and served as the control condition. In Trial 1, the refreshers were delivered in a single episode at 6 months after initial CPR training. In Trial 2, the refreshers were delivered twice, at 6 and 9 months after initial CPR training, to test the effect of a repeated delivery. Outcomes for the three novel refreshers vs. the mailed brochure were determined at 12 months after initial CPR training. Results Assignment to any of three novel refreshers did not improve outcomes of CPR training one year later in comparison with receiving a mailed brochure. Comparing outcomes for subjects who actually reviewed some of the novel refreshers vs. those who did not indicated a significant positive effect for one outcome, confidence for performing CPR. The website refresher was associated with increased behavioral intent to perform CPR. Stated satisfaction with the refreshers was relatively high. The number of episodes of refreshers (one vs. two did not have a significant effect

  5. Novel electronic refreshers for cardiopulmonary resuscitation: a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Currently the American Red Cross requires that individuals renew their cardiopulmonary resuscitation (CPR) certification annually; this often requires a 4- to 8-hour refresher course. Those trained in CPR often show a decrease in essential knowledge and skills within just a few months after training. New electronic means of communication have expanded the possibilities for delivering CPR refreshers to members of the general public who receive CPR training. The study’s purpose was to determine the efficacy of three novel CPR refreshers - online website, e-mail and text messaging – for improving three outcomes of CPR training - skill retention, confidence for using CPR and intention to use CPR. These three refreshers may be considered “novel” in that they are not typically used to refresh CPR knowledge and skills. Methods The study conducted two randomized clinical trials of the novel CPR refreshers. A mailed brochure was a traditional, passive refresher format and served as the control condition. In Trial 1, the refreshers were delivered in a single episode at 6 months after initial CPR training. In Trial 2, the refreshers were delivered twice, at 6 and 9 months after initial CPR training, to test the effect of a repeated delivery. Outcomes for the three novel refreshers vs. the mailed brochure were determined at 12 months after initial CPR training. Results Assignment to any of three novel refreshers did not improve outcomes of CPR training one year later in comparison with receiving a mailed brochure. Comparing outcomes for subjects who actually reviewed some of the novel refreshers vs. those who did not indicated a significant positive effect for one outcome, confidence for performing CPR. The website refresher was associated with increased behavioral intent to perform CPR. Stated satisfaction with the refreshers was relatively high. The number of episodes of refreshers (one vs. two) did not have a significant effect on any outcomes

  6. The reporting quality of randomized controlled trials in orthodontics.

    Science.gov (United States)

    Lempesi, Evangelia; Koletsi, Despina; Fleming, Padhraig S; Pandis, Nikolaos

    2014-06-01

    Accurate trial reporting facilitates evaluation and better use of study results. The objective of this article is to investigate the quality of reporting of randomized controlled trials (RCTs) in leading orthodontic journals, and to explore potential predictors of improved reporting. The 50 most recent issues of 4 leading orthodontic journals until November 2013 were electronically searched. Reporting quality assessment was conducted using the modified CONSORT statement checklist. The relationship between potential predictors and the modified CONSORT score was assessed using linear regression modeling. 128 RCTs were identified with a mean modified CONSORT score of 68.97% (SD = 11.09). The Journal of Orthodontics (JO) ranked first in terms of completeness of reporting (modified CONSORT score 76.21%, SD = 10.1), followed by American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) (73.05%, SD = 10.1). Journal of publication (AJODO: β = 10.08, 95% CI: 5.78, 14.38; JO: β = 16.82, 95% CI: 11.70, 21.94; EJO: β = 7.21, 95% CI: 2.69, 11.72 compared to Angle), year of publication (β = 0.98, 95% CI: 0.28, 1.67 for each additional year), region of authorship (Europe: β = 5.19, 95% CI: 1.30, 9.09 compared to Asia/other), statistical significance (significant: β = 3.10, 95% CI: 0.11, 6.10 compared to non-significant) and methodologist involvement (involvement: β = 5.60, 95% CI: 1.66, 9.54 compared to non-involvement) were all significant predictors of improved modified CONSORT scores in the multivariable model. Additionally, median overall Jadad score was 2 (IQR = 2) across journals, with JO (median = 3, IQR = 1) and AJODO (median = 3, IQR = 2) presenting the highest score values. The reporting quality of RCTs published in leading orthodontic journals is considered suboptimal in various CONSORT areas. This may have a bearing in trial result interpretation and use in clinical decision making and evidence- based orthodontic treatment interventions. Copyright

  7. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Magnusson

    2017-04-01

    Full Text Available Background: A pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket. Methods: In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device. Conclusions: POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  8. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Magnusson

    2017-04-01

    Full Text Available BackgroundA pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket.MethodsIn October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device.ConclusionsPOCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  9. Insecticide effect of cyantraniliprole on tomato moth Tuta absoluta Meyrick (Lepidoptera: Gelechiidae larvae in field trials

    Directory of Open Access Journals (Sweden)

    Patricia Larraín

    2014-04-01

    Full Text Available The tomato moth (Tuta absoluta Meyrick, Lepidoptera: Gelechiidae has traditionally been managed in Chile with organophosphate, pyrethroid, and nereistoxin insecticides; all of these have wide action spectra and high toxicity and many of them have developed rapid resistance. It is therefore important to have new molecules which are effective in controlling this pest; how ever, these molecules must have lower toxicity and greater selectivity for beneficial fauna to produce a more sustainable tomato (Solanum lycopersicum L. production. The objective was to evaluate the effectiveness of T. absoluta control with cyantraniliprole insecticide, which has desirable characteristics for programs of integrated pest management of tomato; we thus performed three trials in the 2009-2010 and 2010-2011 seasons in the Coquimbo Region, Chile. These trials evaluated the control of T. absoluta using different doses of two formulations: cyantraniliprole 10 OD (oil dispersion with or without surfactants (Dyne-Amic, Codacide applied to leaves and cyantraniliprole 20 SC (suspension concentrate applied to soil. Trials used a randomized complete block design with four replicates. The effect of treatments was compared with standard insecticides and a control without insecticide. The degree of control was estimated by foliar and fruit damage at harvest. Results indicate a reduction in fruit damage between 75% and 85% for foliar applications and 82% for soil applications of cyantraniliprole. It is concluded that both formulations of cyantraniliprole were effective to reduce damage caused by the tomato moth larva in both the foliage and fruit of tomato.

  10. Psychosocial benefits of workplace physical exercise: cluster randomized controlled trial.

    Science.gov (United States)

    Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Andersen, Lars L

    2017-10-10

    While benefits of workplace physical exercise on physical health is well known, little is known about the psychosocial effects of such initiatives. This study evaluates the effect of workplace versus home-based physical exercise on psychosocial factors among healthcare workers. A total of 200 female healthcare workers (Age: 42.0, BMI: 24.1) from 18 departments at three hospitals were cluster-randomized to 10 weeks of: 1) home-based physical exercise (HOME) performed alone during leisure time for 10 min 5 days per week or 2) workplace physical exercise (WORK) performed in groups during working hours for 10 min 5 days per week and up to 5 group-based coaching sessions on motivation for regular physical exercise. Vitality and mental health (SF-36, scale 0-100), psychosocial work environment (COPSOQ, scale 0-100), work- and leisure disability (DASH, 0-100), control- (Bournemouth, scale 0-10) and concern about pain (Pain Catastrophizing Scale, scale 0-10) were assessed at baseline and at 10-week follow-up. Vitality as well as control and concern about pain improved more following WORK than HOME (all p health remained unchanged. Between-group differences at follow-up (WORK vs. HOME) were 7 [95% confidence interval (95% CI) 3 to 10] for vitality, -0.8 [95% CI -1.3 to -0.3] for control of pain and -0.9 [95% CI -1.4 to -0.5] for concern about pain, respectively. Performing physical exercise together with colleagues during working hours was more effective than home-based exercise in improving vitality and concern and control of pain among healthcare workers. These benefits occurred in spite of increased work pace. NCT01921764 at ClinicalTrials.gov . Registered 10 August 2013.

  11. A Randomized Controlled Trial of an Eczema Care Plan.

    Science.gov (United States)

    Rea, Corinna J; Tran, Katherine D; Jorina, Maria; Wenren, Larissa M; Hawryluk, Elena B; Toomey, Sara L

    2018-03-02

    To test whether an eczema care plan (ECP) would improve provider documentation and management, decrease eczema severity, and increase patient quality of life (QOL) in the pediatric primary care setting. We conducted a randomized controlled trial from June 2015 to September 2016 at a large hospital-based pediatric primary care clinic. Participants included children from 1 month to 16 years of age with a diagnosis of eczema. The intervention group received the ECP and the control group received usual care. Both groups completed a validated eczema severity scale (Patient-Oriented Eczema Measure [POEM]) and a QOL scale (Infant's Dermatitis Quality of Life Index [IDQOL]) or Children's Dermatology Life Quality Index [CDLQI]) before the visit and again ~1 month later. A total of 211 caregivers completed both the pre- and postintervention surveys (100 control group and 111 intervention group [94% completion]). Intervention group providers were more likely to recommend a comprehensive "step-up" plan (88%) vs 28%; P plan to families (80%) vs 2%; P improved between the pre- and postintervention periods. However, there was not a significant difference between the groups on either measure: POEM difference -0.8, 95% confidence interval (CI) -3.2 to 1.7; IDQOL difference -0.1, 95% CI -1.8 to 1.6; CDLQI difference 0.8, 95% CI -0.9 to 2.6. Intervention group providers documented more comprehensive eczema care than control group providers. Although patients improved on all measures in the postintervention period, the ECP did not augment that improvement. Copyright © 2018 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  12. Endurance exercise training in orthostatic intolerance: a randomized, controlled trial.

    Science.gov (United States)

    Winker, Robert; Barth, Alfred; Bidmon, Daniela; Ponocny, Ivo; Weber, Michael; Mayr, Otmar; Robertson, David; Diedrich, André; Maier, Richard; Pilger, Alex; Haber, Paul; Rüdiger, Hugo W

    2005-03-01

    Orthostatic intolerance is a syndrome characterized by chronic orthostatic symptoms of light-headedness, fatigue, nausea, orthostatic tachycardia, and aggravated norepinephrine levels while standing. The aim of this study was to assess the protective effect of exercise endurance training on orthostatic symptoms and to examine its usefulness in the treatment of orthostatic intolerance. 2768 military recruits were screened for orthostatic intolerance by questionnaire. Tilt-table testing identified 36 cases of orthostatic intolerance out of the 2768 soldiers. Subsequently, 31 of these subjects with orthostatic intolerance entered a randomized, controlled trial. The patients were allocated randomly to either a "training" (3 months jogging) or a "control" group. The influence of exercise training on orthostatic intolerance was assessed by determination of questionnaire scores and tilt-table testing before and after intervention. After training, only 6 individuals of 16 still had orthostatic intolerance compared with 10 of 11 in the control group. The Fisher exact test showed a highly significant difference in diagnosis between the 2 groups (P=0.008) at the end of the study. Analysis of the questionnaire-score showed significant interaction between time and group (P=0.001). The trained subjects showed an improvement in the average symptom score from 1.79+/-0.4 to 1.04+/-0.4, whereas the control subjects showed no significant change in average symptom score (2.09+/-0.6 and 2.14+/-0.5, respectively). Our data demonstrate that endurance exercise training leads to an improvement of symptoms in the majority of patients with orthostatic intolerance. Therefore, we suggest that endurance training should be considered in the treatment of orthostatic intolerance patients.

  13. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    OpenAIRE

    Turner, Deborah E; Helliwell, Philip S; Woodburn, James

    2007-01-01

    Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Method...

  14. Pediatric selective mutism therapy: a randomized controlled trial.

    Science.gov (United States)

    Esposito, Maria; Gimigliano, Francesca; Barillari, Maria R; Precenzano, Francesco; Ruberto, Maria; Sepe, Joseph; Barillari, Umberto; Gimigliano, Raffaele; Militerni, Roberto; Messina, Giovanni; Carotenuto, Marco

    2017-10-01

    Selective mutism (SM) is a rare disease in children coded by DSM-5 as an anxiety disorder. Despite the disabling nature of the disease, there is still no specific treatment. The aims of this study were to verify the efficacy of six-month standard psychomotor treatment and the positive changes in lifestyle, in a population of children affected by SM. Randomized controlled trial registered in the European Clinical Trials Registry (EuDract 2015-001161-36). University third level Centre (Child and Adolescent Neuropsychiatry Clinic). Study population was composed by 67 children in group A (psychomotricity treatment) (35 M, mean age 7.84±1.15) and 71 children in group B (behavioral and educational counseling) (37 M, mean age 7.75±1.36). Psychomotor treatment was administered by trained child therapists in residential settings three times per week. Each child was treated for the whole period by the same therapist and all the therapists shared the same protocol. The standard psychomotor session length is of 45 minutes. At T0 and after 6 months (T1) of treatments, patients underwent a behavioral and SM severity assessment. To verify the effects of the psychomotor management, the Child Behavior Checklist questionnaire (CBCL) and Selective Mutism Questionnaire (SMQ) were administered to the parents. After 6 months of psychomotor treatment SM children showed a significant reduction among CBCL scores such as in social relations, anxious/depressed, social problems and total problems (Pselective mutism, even if further studies are needed. The present study identifies in psychomotricity a safe and efficacy therapy for pediatric selective mutism.

  15. On reporting results from randomized controlled trials with recurrent events

    Directory of Open Access Journals (Sweden)

    Sobolev Boris G

    2008-05-01

    Full Text Available Abstract Background Evidence-based medicine has been advanced by the use of standards for reporting the design and methodology of randomized controlled trials (RCT. Indeed, without this information it is difficult to assess the quality of evidence from an RCT. Although a variety of statistical methods are available for the analysis of recurrent events, reporting the effect of an intervention on outcomes that recur is an area that remains poorly understood in clinical research. The purpose of this paper is to outline guidelines for reporting results from RCTs where the outcome of interest is a recurrent event. Methods We used a simulation study to relate an event process and results from analyses of the gamma-Poisson, independent-increment, conditional, and marginal Cox models. We reviewed the utility of regression models for the rate of a recurrent event by articulating the associated study questions, preenting the risk sets, and interpreting the regression coefficients. Results Based on a single data set produced by simulation, we reported and contrasted results from statistical methods for evaluating treatment effect from an RCT with a recurrent outcome. We showed that each model has different study questions, assumptions, risk sets, and rate ratio interpretation, and so inferences should consider the appropriateness of the model for the RCT. Conclusion Our guidelines for reporting results from an RCT involving a recurrent event suggest that the study question and the objectives of the trial, such as assessing comparable groups and estimating effect size, should determine the statistical methods. The guidelines should allow clinical researchers to report appropriate measures from an RCT for understanding the effect of intervention on the occurrence of a recurrent event.

  16. Pulmonary rehabilitation in lymphangioleiomyomatosis: a controlled clinical trial.

    Science.gov (United States)

    Araujo, Mariana S; Baldi, Bruno G; Freitas, Carolina S G; Albuquerque, André L P; Marques da Silva, Cibele C B; Kairalla, Ronaldo A; Carvalho, Celso R F; Carvalho, Carlos R R

    2016-05-01

    Lymphangioleiomyomatosis (LAM) is a cystic lung disease frequently associated with reduced exercise capacity. The aim of this study was to assess safety and efficacy of pulmonary rehabilitation in LAM.This controlled clinical trial included 40 patients with LAM and a low physical activity level. The pulmonary rehabilitation programme comprised 24 aerobic and muscle strength training sessions and education. The primary outcome was exercise capacity (endurance time during a constant work rate exercise test). Secondary outcomes included health-related quality of life (St George's Respiratory Questionnaire (SGRQ)), 6-min walking distance (6MWD), dyspnoea, peak oxygen consumption (V'O2 ), daily physical activity (pedometer), symptoms of anxiety and depression, lung function and peripheral muscle strength (one-repetition maximum).The baseline characteristics were well balanced between the groups. The pulmonary rehabilitation group exhibited improvements in the following outcomes versus controls: endurance time (median (interquartile range) 169 (2-303) s versus -33 (-129-39) s; p=0.001), SGRQ (median (interquartile range) -8 (-16-2) versus 2 (-4-5); p=0.002) and 6MWD (median (interquartile range) 59 (13-81) m versus 20 (-12-30) m; p=0.002). Dyspnoea, peak V'O2 , daily physical activity and muscle strength also improved significantly. No serious adverse events were observed.Pulmonary rehabilitation is a safe intervention and improves exercise capacity, dyspnoea, daily physical activity, quality of life and muscle strength in LAM. Copyright ©ERS 2016.

  17. Biofeedback treatment for Tourette syndrome: a preliminary randomized controlled trial.

    Science.gov (United States)

    Nagai, Yoko; Cavanna, Andrea E; Critchley, Hugo D; Stern, Jeremy J; Robertson, Mary M; Joyce, Eileen M

    2014-03-01

    To study the clinical effectiveness of biofeedback treatment in reducing tics in patients with Tourette syndrome. Despite advances in the pharmacologic treatment of patients with Tourette syndrome, many remain troubled by their tics, which may be resistant to multiple medications at tolerable doses. Electrodermal biofeedback is a noninvasive biobehavioral intervention that can be useful in managing neuropsychiatric and neurologic conditions. We conducted a randomized controlled trial of electrodermal biofeedback training in 21 patients with Tourette syndrome. After training the patients for 3 sessions a week over 4 weeks, we observed a significant reduction in tic frequency and improved indices of subjective well-being in both the active-biofeedback and sham-feedback (control) groups, but there was no difference between the groups in these measurements. Furthermore, the active-treatment group did not demonstrably learn to reduce their sympathetic electrodermal tone using biofeedback. Our findings indicate that this form of biofeedback training was unable to produce a clinical effect greater than placebo. The main confounding factor appeared to be the 30-minute duration of the training sessions, which made it difficult for patients to sustain a reduction in sympathetic tone when their tics themselves were generating competing phasic electrodermal arousal responses. Despite a negative finding in this study, electrodermal biofeedback training may have a role in managing tics if optimal training schedules can be identified.

  18. Effects of Cupping Therapy in Amateur and Professional Athletes: Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Bridgett, Rhianna; Klose, Petra; Duffield, Rob; Mydock, Suni; Lauche, Romy

    2018-03-01

    Despite the recent re-emergence of the process of cupping by athletes, supporting evidence for its efficacy and safety remains scarce. This systematic review aims to summarize the evidence of clinical trials on cupping for athletes. SCOPUS, Cochrane Library, PubMed, AMED, and CNKI databases were searched from their inception to December 10, 2016. Randomized controlled trials on cupping therapy with no restriction regarding the technique, or cointerventions, were included, if they measured the effects of cupping compared with any other intervention on health and performance outcomes in professionals, semi-professionals, and leisure athletes. Data extraction and risk of bias assessment using the Cochrane Risk of Bias Tool were conducted independently by two pairs of reviewers. Eleven trials with n = 498 participants from China, the United States, Greece, Iran, and the United Arab Emirates were included, reporting effects on different populations, including soccer, football, and handball players, swimmers, gymnasts, and track and field athletes of both amateur and professional nature. Cupping was applied between 1 and 20 times, in daily or weekly intervals, alone or in combination with, for example, acupuncture. Outcomes varied greatly from symptom intensity, recovery measures, functional measures, serum markers, and experimental outcomes. Cupping was reported as beneficial for perceptions of pain and disability, increased range of motion, and reductions in creatine kinase when compared to mostly untreated control groups. The majority of trials had an unclear or high risk of bias. None of the studies reported safety. No explicit recommendation for or against the use of cupping for athletes can be made. More studies are necessary for conclusive judgment on the efficacy and safety of cupping in athletes.

  19. Mapping Field Trial IV Habitat Characterization (EX0907, EM302) on NOAA Ship Okeanos Explorer in Cordell Bank & Gulf of the Farallones National Marine Sanctuaries

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The goals of this field trial cruise are more operational than exploratory. Like other field trials, this cruise has primary and secondary goals and objectives....

  20. Accrual and drop out in a primary prevention randomised controlled trial: qualitative study

    Directory of Open Access Journals (Sweden)

    Price Jackie F

    2011-01-01

    Full Text Available Abstract Background Recruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community. Methods Semi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA trial (N = 11, and AAA trial participants who had stopped taking the trial medication (N = 11. A focus group with further participants who had stopped taking the trial medication (N = 6. (Total participants N = 28. Results Explanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating. Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind. Conclusions These results indicate that when planning trials (especially in preventive medicine particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation. Trial registration ISRCTN66587262

  1. A Feasibility Randomised Controlled Trial of the New Orleans Intervention for Infant Mental Health: A Study Protocol

    Directory of Open Access Journals (Sweden)

    Rachel Pritchett

    2013-01-01

    Full Text Available Child maltreatment is associated with life-long social, physical, and mental health problems. Intervening early to provide maltreated children with safe, nurturing care can improve outcomes. The need for prompt decisions about permanent placement (i.e., regarding adoption or return home is internationally recognised. However, a recent Glasgow audit showed that many maltreated children “revolve” between birth families and foster carers. This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. This trial compares an infant's mental health intervention with the new enhanced service as usual for maltreated children entering care in Glasgow. As both are new services, the trial is being conducted from a position of equipoise. The outcome assessment covers various fields of a child’s neurodevelopment to identify problems in any ESSENCE domain. The feasibility, reliability, and developmental appropriateness of all outcome measures are examined. Additionally, the potential for linkage with routinely collected data on health and social care and, in the future, education is explored. The results will inform a definitive randomised controlled trial that could potentially lead to long lasting benefits for the Scottish population and which may be applicable to other areas of the world. This trial is registered with ClinicalTrials.gov (NC01485510.

  2. Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services.

    Science.gov (United States)

    Bonell, Chris; Moore, Graham; Warren, Emily; Moore, Laurence

    2018-04-19

    We have previously proposed that trials of social interventions can be done within a "realist" research paradigm. Critics have countered that such trials are irredeemably positivist and asked us to explain our philosophical position. We set out to explore what is meant by positivism and whether trials adhere to its tenets (of necessity or in practice) via a narrative literature review of social science and philosophical discussions of positivism, and of the trials literature and three case studies of trials. The philosophical literature described positivism as asserting: (1) the epistemic primacy of sensory information; (2) the requirement that theoretical terms equate with empirical terms; (3) the aim of developing universal laws; and (4) the unity of method between natural and social sciences. Regarding (1), it seems that rather than embodying the epistemic primacy of sensory data, randomised controlled trials (RCTs) of social interventions in health embrace an anti-positivist approach aiming to test hypotheses derived deductively from prior theory. Considering (2), while some RCTs of social interventions appear to limit theorisation to concepts with empirical analogues, others examine interventions underpinned by theories engaging with mechanisms and contextual contingencies not all of which can be measured. Regarding (3), while some trialists and reviewers in the health field do limit their role to estimating statistical trends as a mechanistic form of generalisation, this is not an inevitable feature of RCT-based research. Trials of social interventions can instead aim to generalise at the level of theory which specifies how mechanisms are contingent on context. In terms of (4), while RCTs are used to examine biomedical as well as social interventions in health, RCTs of social interventions are often distinctive in using qualitative analyses of data on participant accounts to examine questions of meaning and agency not pursued in the natural sciences. We

  3. Evaluation of Supercritical Extracts of Algae as Biostimulants of Plant Growth in Field Trials.

    Science.gov (United States)

    Michalak, Izabela; Chojnacka, Katarzyna; Dmytryk, Agnieszka; Wilk, Radosław; Gramza, Mateusz; Rój, Edward

    2016-01-01

    The aim of the field trials was to determine the influence of supercritical algal extracts on the growth and development of winter wheat (variety Akteur ). As a raw material for the supercritical fluid extraction, the biomass of microalga Spirulina plantensis , brown seaweed - Ascophyllum nodosum and Baltic green macroalgae was used. Forthial and Asahi SL constituted the reference products. It was found that the tested biostimulants did not influence statistically significantly the plant height, length of ear, and shank length. The ear number per m 2 was the highest in the group where the Baltic macroalgae extract was applied in the dose 1.0 L/ha (statistically significant differences). Number of grains in ear (statistically significant differences) and shank length was the highest in the group treated with Spirulina at the dose 1.5 L/ha. In the group with Ascophyllum at the dose 1.0 L/ha, the highest length of ear was observed. The yield was comparable in all the experimental groups (lack of statistically significant differences). Among the tested supercritical extracts, the best results were obtained for Spirulina (1.5 L/ha). The mass of 1000 grains was the highest for extract from Baltic macroalgae and was 3.5% higher than for Asahi, 4.0% higher than for Forthial and 18.5% higher than for the control group (statistically significant differences). Future work is needed to fully characterize the chemical composition of the applied algal extracts. A special attention should be paid to the extracts obtained from Baltic algae because they are inexpensive source of naturally occurring bioactive compounds, which can be used in sustainable agriculture and horticulture.

  4. Evaluation of supercritical extracts of algae as biostimulants of plant growth in field trials

    Directory of Open Access Journals (Sweden)

    Izabela Michalak

    2016-10-01

    Full Text Available The aim of the field trials was to determine the influence of supercritical algal extracts on the growth and development of winter wheat (variety Akteur. As a raw material for the supercritical fluid extraction (SFE, the biomass of microalga Spirulina plantensis, brown seaweed – Ascophyllum nodosum and Baltic green macroalgae was used. Forthial and Asahi SL constituted the reference products. It was found that the tested biostimulants did not influence statistically significantly the plant height, length of ear and shank length. The ear number per square meter was the highest in the group where the Baltic macroalgae extract was applied in the dose 1.0 L/ha (statistically significant differences. Number of grains in ear (statistically significant differences and shank length was the highest in the group treated with Spirulina at the dose 1.5 L/ha. In the group with Ascophyllum at the dose 1.0 L/ha, the highest length of ear was observed. The yield was comparable in all the experimental groups (lack of statistically significant differences.Among the tested supercritical extracts, the best results were obtained for Spirulina (1.5 L/ha. The mass of 1000 grains was the highest for extract from Baltic macroalgae and was 3.5% higher than for Asahi, 4.0% higher than for Forthial and 18.5% higher than for the control group (statistically significant differences. Future work is needed to fully characterize the chemical composition of the applied algal extracts. A special attention should be paid to the extracts obtained from Baltic algae because they are inexpensive source of naturally occurring bioactive compounds, which can be used in sustainable agriculture and horticulture.

  5. Full Scale Field Trial of the Low Temperature Mercury Capture Process

    Energy Technology Data Exchange (ETDEWEB)

    Locke, James [CONSOL Energy Inc., South Park, PA (United States); Winschel, Richard [CONSOL Energy Inc., South Park, PA (United States)

    2012-05-21

    CONSOL Energy Inc., with partial funding from the Department of Energy (DOE) National Energy Technology Laboratory, designed a full-scale installation for a field trial of the Low-Temperature Mercury Control (LTMC) process, which has the ability to reduce mercury emissions from coal-fired power plants by over 90 percent, by cooling flue gas temperatures to approximately 230°F and absorbing the mercury on the native carbon in the fly ash, as was recently demonstrated by CONSOL R&D on a slip-stream pilot plant at the Allegheny Energy Mitchell Station with partial support by DOE. LTMC has the potential to remove over 90 percent of the flue gas mercury at a cost at least an order of magnitude lower (on a $/lb mercury removed basis) than activated carbon injection. The technology is suitable for retrofitting to existing and new plants, and, although it is best suited to bituminous coal-fired plants, it may have some applicability to the full range of coal types. Installation plans were altered and moved from the original project host site, PPL Martins Creek plant, to a second host site at Allegheny Energy's R. Paul Smith plant, before installation actually occurred at the Jamestown (New York) Board of Public Utilities (BPU) Samuel A. Carlson (Carlson) Municipal Generating Station Unit 12, where the LTMC system was operated on a limited basis. At Carlson, over 60% mercury removal was demonstrated by cooling the flue gas to 220-230°F at the ESP inlet via humidification. The host unit ESP operation was unaffected by the humidification and performed satisfactorily at low temperature conditions.

  6. Genetic test feedback with weight control advice: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Meisel Susanne F

    2012-12-01

    Full Text Available Abstract Background Genetic testing for risk of weight gain is already available over the internet despite uncertain benefits and concerns about adverse emotional or behavioral effects. Few studies have assessed the effect of adding genetic test feedback to weight control advice, even though one of the proposed applications of genetic testing is to stimulate preventive action. This study will investigate the motivational effect of adding genetic test feedback to simple weight control advice in a situation where weight gain is relatively common. Methods/design First-year university students (n = 800 will be randomized to receive either 1 their personal genetic test result for a gene (FTO related to weight gain susceptibility in addition to a leaflet with simple weight control advice (‘Feedback + Advice’ group, FA, or 2 only the leaflet containing simple weight control advice (‘Advice Only’ group, AO. Motivation to avoid weight gain and active use of weight control strategies will be assessed one month after receipt of the leaflet with or without genetic test feedback. Weight and body fat will be measured at baseline and eight months follow-up. We will also assess short-term psychological reactions to the genetic test result. In addition, we will explore interactions between feedback condition and gene test status. Discussion We hope to provide a first indication of the clinical utility of weight-related genetic test feedback in the prevention context. Trial registration Current controlled trials ISRCTN91178663

  7. Control of colloids with gravity, temperature gradients, and electric fields

    CERN Document Server

    Sullivan, M; Harrison, C; Austin, R H; Megens, M; Hollingsworth, A; Russel, W B; Cheng Zhen; Mason, T; Chaikin, P M

    2003-01-01

    We have used a variety of different applied fields to control the density, growth, and structure of colloidal crystals. Gravity exerts a body force proportional to the buoyant mass and in equilibrium produces a height-dependent concentration profile. A similar body force can be obtained with electric fields on charged particles (electrophoresis), a temperature gradient on all particles, or an electric field gradient on uncharged particles (dielectrophoresis). The last is particularly interesting since its magnitude and sign can be changed by tuning the applied frequency. We study these effects in bulk (making 'dielectrophoretic bottles' or traps), to control concentration profiles during nucleation and growth and near surfaces. We also study control of non-spherical and optically anisotropic particles with the light field from laser tweezers.

  8. Control of colloids with gravity, temperature gradients, and electric fields

    Energy Technology Data Exchange (ETDEWEB)

    Sullivan, Matt [Department of Physics, Princeton University, Princeton, NJ (United States); Zhao Kun [Department of Physics, Princeton University, Princeton, NJ (United States); Harrison, Christopher [Department of Physics, Princeton University, Princeton, NJ (United States); Austin, Robert H [Department of Physics, Princeton University, Princeton, NJ (United States); Megens, Mischa [Department of Physics, Princeton University, Princeton, NJ (United States); Hollingsworth, Andrew [Department of Chemical Engineering, Princeton University, Princeton, NJ (United States); Russel, William B [Department of Chemical Engineering, Princeton University, Princeton, NJ (United States); Cheng Zhengdong [ExxonMobil Research, Annandale, NJ (United States); Mason, Thomas [ExxonMobil Research, Annandale, NJ (United States); Chaikin, P M [Department of Physics, Princeton University, Princeton, NJ (United States)

    2003-01-15

    We have used a variety of different applied fields to control the density, growth, and structure of colloidal crystals. Gravity exerts a body force proportional to the buoyant mass and in equilibrium produces a height-dependent concentration profile. A similar body force can be obtained with electric fields on charged particles (electrophoresis), a temperature gradient on all particles, or an electric field gradient on uncharged particles (dielectrophoresis). The last is particularly interesting since its magnitude and sign can be changed by tuning the applied frequency. We study these effects in bulk (making 'dielectrophoretic bottles' or traps), to control concentration profiles during nucleation and growth and near surfaces. We also study control of non-spherical and optically anisotropic particles with the light field from laser tweezers.

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

    Science.gov (United States)

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

    2012-01-01

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

  10. Control of radial electric field in torus plasma

    International Nuclear Information System (INIS)

    Ida, K.; Idei, H.; Sanuki, H.

    1994-09-01

    The radial electric fields is controlled by changing the direction of neutral beam from co to counter to plasma current in tokamak, while it is controlled by the 2nd harmonic ECH and NBI and pellet injection in heliotron/torsatron. (author)

  11. Suppression and control of leakage field in electromagnetic helical microwiggler

    Energy Technology Data Exchange (ETDEWEB)

    Ohigashi, N. [Kansai Univ., Osaka (Japan); Tsunawaki, Y. [Osaka Sangyo Univ. (Japan); Imasaki, K. [Institute for Laser Technology, Osaka (Japan)] [and others

    1995-12-31

    Shortening the period of electromagnetic wiggler introduces both the radical increase of the leakage field and the decrease of the field in the gap region. The leakage field is severer problem in planar electromagnetic wiggler than in helical wiggler. Hence, in order to develop a short period electromagnetic wiggler, we have adopted {open_quotes}three poles per period{close_quotes} type electromagnetic helical microwiggler. In this work, we inserted the permanent magnet (PM) blocks with specific magnetized directions in the space between magnetic poles, for suppressing the leakage field flowing out from a pole face to the neighboring pole face. These PM-blocks must have higher intrinsic coersive force than saturation field of pole material. The gap field due to each pole is adjustable by controlling the leakage fields, that is, controlling the position of each iron screw set in each retainer fixing the PM-blocks. At present time, a test wiggler with period 7.8mm, periodical number 10 and gap length 4.6mm has been manufactured. Because the ratio of PM-block aperture to gap length is important parameter to suppress the leakage field, the parameter has been surveyed experimentally for PM-blocks with several dimensions of aperture. The field strength of 3-5kG (K=0.2-0.4) would be expected in the wiggler.

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

    Science.gov (United States)

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

    2011-10-01

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

  13. Controllability of linear vector fields on Lie groups

    International Nuclear Information System (INIS)

    Ayala, V.; Tirao, J.

    1994-11-01

    In this paper, we shall deal with a linear control system Σ defined on a Lie group G with Lie algebra g. The dynamic of Σ is determined by the drift vector field which is an element in the normalizer of g in the Lie algebra of all smooth vector field on G and by the control vectors which are elements in g considered as left-invariant vector fields. We characterize the normalizer of g identifying vector fields on G with C ∞ -functions defined on G into g. For this class of control systems we study algebraic conditions for the controllability problem. Indeed, we prove that if the drift vector field has a singularity then the Lie algebra rank condition is necessary for the controllability property, but in general this condition does not determine this property. On the other hand, we show that the rank (ad-rank) condition is sufficient for the controllability of Σ. In particular, we extend the fundamental Kalman's theorem when G is an Abelian connected Lie group. Our work is related with a paper of L. Markus and we also improve his results. (author). 7 refs

  14. Telemedical support for prehospital Emergency Medical Service (TEMS trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Stevanovic, Ana; Beckers, Stefan Kurt; Czaplik, Michael; Bergrath, Sebastian; Coburn, Mark; Brokmann, Jörg Christian; Hilgers, Ralf-Dieter; Rossaint, Rolf

    2017-01-26

    Increasing numbers of emergency calls, shortages of Emergency Medical Service (EMS), physicians, prolonged emergency response times and regionally different quality of treatment by EMS physicians require improvement of this system. Telemedical solutions have been shown to be beneficial in different emergency projects, focused on specific disease patterns. Our previous pilot studies have shown that the implementation of a holistic prehospital EMS teleconsultation system, between paramedics and experienced tele-EMS physicians, is safe and feasible in different emergency situations. We aim to extend the clinical indications for this teleconsultation system. We hypothesize that the use of a tele-EMS physician is noninferior regarding the occurrence of system-induced patient adverse events and superior regarding secondary outcome parameters, such as the quality of guideline-conforming treatment and documentation, when compared to conventional EMS-physician treatment. Three thousand and ten patients will be included in this single-center, open-label, randomized controlled, noninferiority trial with two parallel arms. According to the inclusion criteria, all emergency cases involving adult patients who require EMS-physician treatment, excluding life-threatening cases, will be randomly assigned by the EMS dispatching center into two groups. One thousand five hundred and five patients in the control group will be treated by a conventional EMS physician on scene, and 1505 patients in the intervention group will be treated by paramedics who are concurrently instructed by the tele-EMS physicians at the teleconsultation center. The primary outcome measure will include the rate of treatment-specific adverse events in relation to the kind of EMS physician used. The secondary outcome measures will record the specific treatment-associated quality indicators. The evidence underlines the better quality of service using telemedicine networks between medical personnel and medical

  15. Job maintenance through Supported Employment PLUS: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nils-Torge Telle

    2016-09-01

    Full Text Available Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N = 99 employees who reported mental distress due to work-related problems. The intervention group (n = 58 received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group (n = 41 received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention and at a 3-month follow up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.

  16. Job Maintenance through Supported Employment PLUS: A Randomized Controlled Trial.

    Science.gov (United States)

    Telle, Nils-Torge; Moock, Jörn; Heuchert, Sandra; Schulte, Vivian; Rössler, Wulf; Kawohl, Wolfram

    2016-01-01

    Sickness absence from work due to experienced distress and mental health issues has continuously increased over the past years in Germany. To investigate how this alarming development can be counteracted, we conducted a randomized controlled trial evaluating a job coaching intervention to maintain the working capacity of members of staff and ultimately prevent sickness absence. Our sample included N  = 99 employees who reported mental distress due to work-related problems. The intervention group ( n  = 58) received between 8 and 12 individual job coaching sessions in which they worked with a professional job coach to reduce their mental distress. The control group ( n  = 41) received a brochure about mental distress. Data were collected before the start of the study, at the end of the job coaching intervention, and at a 3-month follow-up. These data included the number of sickness absence days as the primary outcome and questionnaire measures to assess burnout indicators, life satisfaction, and work-related experiences and behaviors. Compared with the control group, the results indicated no reduction in sickness absence in the intervention group but fewer depressive symptoms, a heightened ability of the participants to distance themselves from work, more experience of work-related success, less depletion of emotional resources, and a greater satisfaction with life when participants had received the job coaching. Thus, although we could not detect a reduction in sickness absence between the groups, job coaching was shown to be a viable intervention technique to benefit employees by contributing to re-establish their mental health. We discuss the implications of the study and outline future research.

  17. A randomized controlled trial of interim methadone maintenance.

    Science.gov (United States)

    Schwartz, Robert P; Highfield, David A; Jaffe, Jerome H; Brady, Joseph V; Butler, Carol B; Rouse, Charles O; Callaman, Jason M; O'Grady, Kevin E; Battjes, Robert J

    2006-01-01

    Effective alternatives to long waiting lists for entry into methadone hydrochloride maintenance treatment are needed to reduce the complications of continuing heroin dependence and to increase methadone treatment entry. To compare the effectiveness of interim methadone maintenance with that of the usual waiting list condition in facilitating methadone treatment entry and reducing heroin and cocaine use and criminal behavior. Randomized, controlled, clinical trial using 2 conditions, with treatment assignment on a 3:2 basis to interim maintenance-waiting list control. A methadone treatment program in Baltimore. A total of 319 individuals meeting the criteria for current heroin dependence and methadone maintenance treatment. Participants were randomly assigned to either interim methadone maintenance, consisting of an individually determined methadone dose and emergency counseling only for up to 120 days, or referral to community-based methadone treatment programs. Entry into comprehensive methadone maintenance therapy at 4 months from baseline; self-reported days of heroin use, cocaine use, and criminal behavior; and number of urine drug test results positive for heroin and cocaine at the follow-up interview conducted at time of entry into comprehensive methadone treatment (or at 4 months from baseline for participants who did not enter regular treatment). Significantly more participants assigned to the interim methadone maintenance condition entered comprehensive methadone maintenance treatment by the 120th day from baseline (75.9%) than those assigned to the waiting list control condition (20.8%) (Pmethadone maintenance results in a substantial increase in the likelihood of entry into comprehensive treatment, and is an effective means of reducing heroin use and criminal behavior among opioid-dependent individuals awaiting entry into a comprehensive methadone treatment program.

  18. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    Science.gov (United States)

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

  19. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Farah Jindani

    2015-01-01

    Full Text Available Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25. KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

  20. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

    Science.gov (United States)

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

    2015-01-01

    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

  1. Safe household water treatment and storage using ceramic drip filters: a randomised controlled trial in Bolivia.

    Science.gov (United States)

    Clasen, T; Brown, J; Suntura, O; Collin, S

    2004-01-01

    A randomised controlled field trial was conducted to evaluate the effectiveness of ceramic drip filters to improve the microbiological quality of drinking water in a low-income community in rural Bolivia. In four rounds of water sampling over five months, 100% of the samples were free of thermotolerant (faecal) coliforms (TTC) compared to an arithmetic mean TTC count of 1517, 406, 167 and 245 among control households which continued to use their customary sources of drinking water. The filter systems produced water that consistently met WHO drinking-water standards despite levels of turbidity that presented a challenge to other low-cost POU treatment methods. The filter systems also demonstrated an ability to maintain the high quality of the treated water against subsequent re-contamination in the home.

  2. Individual energy use and feedback in an office setting: A field trial

    International Nuclear Information System (INIS)

    Murtagh, Niamh; Nati, Michele; Headley, William R.; Gatersleben, Birgitta; Gluhak, Alexander; Imran, Muhammad Ali; Uzzell, David

    2013-01-01

    Despite national plans to deploy smart meters in small and medium businesses in the UK, there is little knowledge of occupant energy use in offices. The objectives of the study were to investigate the effect of individual feedback on energy use at the workdesk, and to test the relationship between individual determinants, energy use and energy reduction. A field trial is presented, which monitored occupant energy use and provided individual feedback to 83 office workers in a university. The trial comprised pre- and post-intervention surveys, energy measurement and provision of feedback for 18 weeks post-baseline, and two participant focus groups. The main findings were: statistically significant energy reduction was found, but not for the entire measurement period; engagement with feedback diminished over time; no measured individual variables were related to energy reduction and only attitudes to energy conservation were related to energy use; an absence of motivation to undertake energy reduction actions was in evidence. The implications for energy use in offices are considered, including the need for motivations beyond energy reduction to be harnessed to realise the clear potential for reduced energy use at workdesks. -- Highlights: •First study on individual energy use and feedback in offices. •Field trial with 83 office workers, measuring plug load at desks over 18 weeks. •Feedback resulted in energy reduction although not consistently. •Sizeable minority did not engage with the feedback. •Lack of motivation to conserve energy evident in focus groups

  3. Field trial using bone meal amendments to remediate mine waste derived soil contaminated with zinc, lead and cadmium

    International Nuclear Information System (INIS)

    Sneddon, I.R.; Orueetxebarria, M.; Hodson, M.E.; Schofield, P.F.; Valsami-Jones, E.

    2008-01-01

    Bone meal amendments are being considered as a remediation method for metal-contaminated wastes. In various forms (biogenic, geogenic or synthetic), apatite, the principal mineral constituent of bone, has shown promise as an amendment to remediate metal-contaminated soils via the formation of insoluble phosphates of Pb and possibly other metals. The efficacy of commercially available bovine bone meal in this role was investigated in a field trial at Nenthead, Cumbria with a mine waste derived soil contaminated with Zn, Pb and Cd. Two 5 m 2 plots were set up; the first as a control and the second, a treatment plot where the soil was thoroughly mixed with bone meal to a depth of 50 cm at a soil to amendment ratio of 25:1 by weight. An array of soil solution samplers (Rhizon SMS TM ) were installed in both plots and the soil pore water was collected and analysed for Ca, Cd, Zn and Pb regularly over a period of 2 a. Concurrently with the field trial, a laboratory trial with 800 mm high and 100 mm wide leaching columns was conducted using identical samplers and with soil from the field site. A substantial release of Zn, Pb, Cd and Ca was observed associated with the bone meal treatment. This release was transient in the case of the leaching columns, and showed seasonal variation in the case of the field trial. It is proposed that this effect resulted from metal complexation with organic acids released during breakdown of the bone meal organic fraction and was facilitated by the relatively high soil pH of 7.6-8.0. Even after this transient release effect had subsided or when incinerated bone meal was substituted in order to eliminate the organic fraction, no detectable decrease in dissolved metals was observed and no P was detected in solution, in contrast with an earlier small column laboratory study. It is concluded that due to the relative insolubility of apatite at above-neutral pH, the rate of supply of phosphate to soil solution was insufficient to result in

  4. Controlling turbulent drag across electrolytes using electric fields.

    Science.gov (United States)

    Ostilla-Mónico, Rodolfo; Lee, Alpha A

    2017-07-01

    Reversible in operando control of friction is an unsolved challenge that is crucial to industrial tribology. Recent studies show that at low sliding velocities, this control can be achieved by applying an electric field across electrolyte lubricants. However, the phenomenology at high sliding velocities is yet unknown. In this paper, we investigate the hydrodynamic friction across electrolytes under shear beyond the transition to turbulence. We develop a novel, highly parallelised numerical method for solving the coupled Navier-Stokes Poisson-Nernst-Planck equation. Our results show that turbulent drag cannot be controlled across dilute electrolytes using static electric fields alone. The limitations of the Poisson-Nernst-Planck formalism hint at ways in which turbulent drag could be controlled using electric fields.

  5. Theorizing Surveillance in the UK Crime Control Field

    Directory of Open Access Journals (Sweden)

    Michael McCahill

    2015-09-01

    Full Text Available Drawing upon the work of Pierre Bourdieu and Loic Wacquant, this paper argues that the demise of the Keynesian Welfare State (KWS and the rise of neo-liberal economic policies in the UK has placed new surveillance technologies at the centre of a reconfigured “crime control field” (Garland, 2001 designed to control the problem populations created by neo-liberal economic policies (Wacquant, 2009a. The paper also suggests that field theory could be usefully deployed in future research to explore how wider global trends or social forces, such as neo-liberalism or bio-power, are refracted through the crime control field in different national jurisdictions. We conclude by showing how this approach provides a bridge between society-wide analysis and micro-sociology by exploring how the operation of new surveillance technologies is mediated by the “habitus” of surveillance agents working in the crime control field and contested by surveillance subjects.

  6. Complex envelope control of pulsed accelerating fields in superconducting cavities

    CERN Document Server

    Czarski, T

    2010-01-01

    A digital control system for superconducting cavities of a linear accelerator is presented in this work. FPGA (Field Programmable Gate Arrays) based controller, managed by MATLAB, was developed to investigate a novel firmware implementation. The LLRF - Low Level Radio Frequency system for FLASH project in DESY is introduced. Essential modeling of a cavity resonator with signal and power analysis is considered as a key approach to the control methods. An electrical model is represented by the non-stationary state space equation for the complex envelope of the cavity voltage driven by the current generator and the beam loading. The electromechanical model of the superconducting cavity resonator including the Lorentz force detuning has been developed for a simulation purpose. The digital signal processing is proposed for the field vector detection. The field vector sum control is considered for multiple cavities driven by one klystron. An algebraic, complex domain model is proposed for the system analysis. The c...

  7. Evaluation of completeness of selected poison control center data fields.

    Science.gov (United States)

    Jaramillo, Jeanie E; Marchbanks, Brenda; Willis, Branch; Forrester, Mathias B

    2010-08-01

    Poison control center data are used in research and surveillance. Due to the large volume of information, these efforts are dependent on data being recorded in machine readable format. However, poison center records include non-machine readable text fields and machine readable coded fields, some of which are duplicative. Duplicating this data increases the chance of inaccurate/incomplete coding. For surveillance efforts to be effective, coding should be complete and accurate. Investigators identified a convenience sample of 964 records and reviewed the substance code determining if it matched its text field. They also reviewed the coded clinical effects and treatments determining if they matched the notes text field. The substance code matched its text field for 91.4% of the substances. The clinical effects and treatments codes matched their text field for 72.6% and 82.4% of occurrences respectively. This under-reporting of clinical effects and treatments has surveillance and public health implications.

  8. Active management of the third stage of labour without controlled cord traction: a randomized non-inferiority controlled trial

    Directory of Open Access Journals (Sweden)

    Derman Richard

    2009-01-01

    Full Text Available Abstract Background The third stage of labour refers to the period between birth of the baby and complete expulsion of the placenta. Some degree of blood loss occurs after the birth of the baby due to separation of the placenta. This period is a risky period because uterus may not contract well after birth and heavy blood loss can endanger the life of the mother. Active management of the third stage of labour (AMTSL reduces the occurrence of severe postpartum haemorrhage by approximately 60–70%. Active management consists of several interventions packaged together and the relative contribution of each of the components is unknown. Controlled cord traction is one of those components that require training in manual skill for it to be performed appropriately. If it is possible to dispense with controlled cord traction without losing efficacy it would have major implications for effective management of the third stage of labour at peripheral levels of health care. Objective The primary objective is to determine whether the simplified package of oxytocin 10 IU IM/IV is not less effective than the full AMTSL package. Methods A hospital-based, multicentre, individually randomized controlled trial is proposed. The hypothesis tested will be a non-inferiority hypothesis. The aim will be to determine whether the simplified package without CCT, with the advantage of not requiring training to acquire the manual skill to perform this task, is not less effective than the full AMTSL package with regard to reducing blood loss in the third stage of labour. The simplified package will include uterotonic (oxytocin 10 IU IM injection after delivery of the baby and cord clamping and cutting at approximately 3 minutes after birth. The full package will include the uterotonic injection (oxytocin 10 IU IM, controlled cord traction following observation of uterine contraction and cord clamping and cutting at approximately 3 minutes after birth. The primary outcome

  9. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    Science.gov (United States)

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  10. Accrual and drop out in a primary prevention randomised controlled trial: qualitative study.

    Science.gov (United States)

    Eborall, Helen C; Stewart, Marlene C W; Cunningham-Burley, Sarah; Price, Jackie F; Fowkes, F Gerry R

    2011-01-11

    Recruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community. Semi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA) trial (N = 11), and AAA trial participants who had stopped taking the trial medication (N = 11). A focus group with further participants who had stopped taking the trial medication (N = 6). (Total participants N = 28). Explanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating.Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind. These results indicate that when planning trials (especially in preventive medicine) particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation. ISRCTN66587262.

  11. Initial Field Trial of a Coach-Supported Web-Based Depression Treatment.

    Science.gov (United States)

    Schueller, Stephen M; Mohr, David C

    2015-08-01

    Early web-based depression treatments were often self-guided and included few interactive elements, instead focusing mostly on delivering informational content online. Newer programs include many more types of features. As such, trials should analyze the ways in which people use these sites in order to inform the design of subsequent sites and models of support. The current study describes of a field trial consisting of 9 patients with major depressive disorder who completed a 12-week program including weekly coach calls. Patients usage varied widely, however, patients who formed regular patterns tended to persist with the program for the longest. Future sites might be able to facilitate user engagement by designing features to support regular use and to use coaches to help establish patterns to increase long-term use and benefit.

  12. Treatment for symptomatic bacterial vaginosis: a randomized controlled trial

    International Nuclear Information System (INIS)

    Tariq, N.; Basharat, A.; Fahim, A.

    2017-01-01

    Objective: To compare the efficacy of multiple doses of vaginal clindamycin with a single oral dose of secnidazole for the treatment of bacterial vaginosis. Study Design: Double-blinded randomized controlled trial. Place and Duration of Study: Shifa Foundation Community Health Center, from March 2012 till February 2015. Methodology: After obtaining written informed consent, a pelvic examination was performed for the confirmation of symptoms of milky white vaginal discharge on speculum examination, positive Amine test and presence of clue cells on microscopy. Pregnant women, known diabetes or any immunocompromised condition, were excluded. Blinding of the patient, doctor, and the pharmacist was done. Study cohort was then divided into two groups, Group A received medicine pack A which contained active clindamycin and placebo oral preparation, whereas group B was given pack B which contained active 2-gm secnidazole with placebo vaginal cream. Primary outcome and therapeutic success were defined by correction of two out of three (normal Nugent score, negative Amine test, and no milky white discharge) on day 15. Results: At 15th day of treatment, 96.6% participants in vaginal clindamycin group (Group A), recovered from the bacterial vaginosis; whereas, (group B) 23% patients were cured in oral secnidazole group. Conclusion: Multiple doses of vaginal clindamycin are superior to single dose of oral secnidazole for the treatment of bacterial vaginosis. (author)

  13. Dry cupping for plantar fasciitis: a randomized controlled trial.

    Science.gov (United States)

    Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

    2017-05-01

    [Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested.

  14. Prenatal docosahexaenoic acid supplementation and infant morbidity: randomized controlled trial.

    Science.gov (United States)

    Imhoff-Kunsch, Beth; Stein, Aryeh D; Martorell, Reynaldo; Parra-Cabrera, Socorro; Romieu, Isabelle; Ramakrishnan, Usha

    2011-09-01

    Long-chain polyunsaturated fatty acids such as docosahexaenoic acid (DHA) influence immune function and inflammation; however, the influence of maternal DHA supplementation on infant morbidity is unknown. We investigated the effects of prenatal DHA supplementation on infant morbidity. In a double-blind randomized controlled trial conducted in Mexico, pregnant women received daily supplementation with 400 mg of DHA or placebo from 18 to 22 weeks' gestation through parturition. In infants aged 1, 3, and 6 months, caregivers reported the occurrence of common illness symptoms in the preceding 15 days. Data were available at 1, 3, and 6 months for 849, 834, and 834 infants, respectively. The occurrence of specific illness symptoms did not differ between groups; however, the occurrence of a combined measure of cold symptoms was lower in the DHA group at 1 month (OR: 0.76; 95% CI: 0.58-1.00). At 1 month, the DHA group experienced 26%, 15%, and 30% shorter duration of cough, phlegm, and wheezing, respectively, but 22% longer duration of rash (all P ≤ .01). At 3 months, infants in the DHA group spent 14% less time ill (P DHA group experienced 20%, 13%, 54%, 23%, and 25% shorter duration of fever, nasal secretion, difficulty breathing, rash, and "other illness," respectively, but 74% longer duration of vomiting (all P DHA supplementation during pregnancy decreased the occurrence of colds in children at 1 month and influenced illness symptom duration at 1, 3, and 6 months.

  15. Measurement model choice influenced randomized controlled trial results.

    Science.gov (United States)

    Gorter, Rosalie; Fox, Jean-Paul; Apeldoorn, Adri; Twisk, Jos

    2016-11-01

    In randomized controlled trials (RCTs), outcome variables are often patient-reported outcomes measured with questionnaires. Ideally, all available item information is used for score construction, which requires an item response theory (IRT) measurement model. However, in practice, the classical test theory measurement model (sum scores) is mostly used, and differences between response patterns leading to the same sum score are ignored. The enhanced differentiation between scores with IRT enables more precise estimation of individual trajectories over time and group effects. The objective of this study was to show the advantages of using IRT scores instead of sum scores when analyzing RCTs. Two studies are presented, a real-life RCT, and a simulation study. Both IRT and sum scores are used to measure the construct and are subsequently used as outcomes for effect calculation. The bias in RCT results is conditional on the measurement model that was used to construct the scores. A bias in estimated trend of around one standard deviation was found when sum scores were used, where IRT showed negligible bias. Accurate statistical inferences are made from an RCT study when using IRT to estimate construct measurements. The use of sum scores leads to incorrect RCT results. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. Medication reconciliation at patient admission: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mendes AE

    2016-03-01

    Full Text Available Objective: To measure length of hospital stay (LHS in patients receiving medication reconciliation. Secondary characteristics included analysis of number of preadmission medications, medications prescribed at admission, number of discrepancies, and pharmacists interventions done and accepted by the attending physician. Methods: A 6 month, randomized, controlled trial conducted at a public teaching hospital in southern Brazil. Patients admitted to general wards were randomized to receive usual care or medication reconciliation, performed within the first 72 hours of hospital admission. Results: The randomization process assigned 68 patients to UC and 65 to MR. LHS was 10±15 days in usual care and 9±16 days in medication reconciliation (p=0.620. The total number of discrepancies was 327 in the medication reconciliation group, comprising 52.6% of unintentional discrepancies. Physicians accepted approximately 75.0% of the interventions. Conclusion: These results highlight weakness at patient transition care levels in a public teaching hospital. LHS, the primary outcome, should be further investigated in larger studies. Medication reconciliation was well accepted by physicians and it is a useful tool to find and correct discrepancies, minimizing the risk of adverse drug events and improving patient safety.

  17. Validating Obstetric Emergency Checklists using Simulation: A Randomized Controlled Trial.

    Science.gov (United States)

    Bajaj, Komal; Rivera-Chiauzzi, Enid Y; Lee, Colleen; Shepard, Cynthia; Bernstein, Peter S; Moore-Murray, Tanya; Smith, Heather; Nathan, Lisa; Walker, Katie; Chazotte, Cynthia; Goffman, Dena

    2016-10-01

    Background The World Health Organization's Surgical Safety Checklist has demonstrated significant reduction in surgical morbidity. The American Congress of Obstetricians and Gynecologists District II Safe Motherhood Initiative (SMI) safety bundles include eclampsia and postpartum hemorrhage (PPH) checklists. Objective To determine whether use of the SMI checklists during simulated obstetric emergencies improved completion of critical actions and to elicit feedback to facilitate checklist revision. Study Design During this randomized controlled trial, teams were assigned to use a checklist during one of two emergencies: eclampsia and PPH. Raters scored teams on critical step completion. Feedback was elicited through structured debriefing. Results In total, 30 teams completed 60 scenarios. For eclampsia, trends toward higher completion were noted for blood pressure and airway management. For PPH, trends toward higher completion rates were noted for PPH stage assessment and fundal massage. Feedback resulted in substantial checklist revision. Participants were enthusiastic about using checklists in a clinical emergency. Conclusion Despite trends toward higher rates of completion of critical tasks, teams using checklists did not approach 100% task completion. Teams were interested in the application of checklists and provided feedback necessary to substantially revise the checklists. Intensive implementation planning and training in use of the revised checklists will result in improved patient outcomes. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  18. Trapped magnetic field measurements on HTS bulk by peak controlled pulsed field magnetization

    International Nuclear Information System (INIS)

    Ida, Tetsuya; Watasaki, Masahiro; Kimura, Yosuke; Miki, Motohiro; Izumi, Mitsuru

    2010-01-01

    For the past several years, we have studied the high-temperature superconducting (HTS) synchronous motor assembled with melt-textured Gd-Ba-Cu-O bulk magnets. If the single pulse field magnetizes a bulk effectively, size of electrical motor will become small for the strong magnetic field of the HTS magnets without reducing output power of motor. In the previous study, we showed that the HTS bulk was magnetized to excellent cone-shape magnetic field distribution by using the waveform control pulse magnetization (WCPM) method. The WCPM technique made possible the active control of the waveform on which magnetic flux motion depended. We generated the pulse waveform with controlled risetime for HTS bulk magnetization to suppress the magnetic flux motion which decreases magnetization efficiency. The pulsed maximum magnetic flux density with slow risetime is not beyond the maximum magnetic flux density which is trapped by the static field magnetization. But, as for applying the pulse which has fast risetime, the magnetic flux which exceed greatly the threshold penetrates the bulk and causes the disorder of the trapped magnetic distribution. This fact suggests the possibility that the threshold at pulsed magnetization influences the dynamic magnetic flux motion. In this study, Gd-Ba-Cu-O bulk is magnetized by the controlled arbitrary trapezoidal shape pulse, of which the maximum magnetic flux density is controlled not to exceed the threshold. We will present the trapped magnetic characteristics and the technique to generate the controlled pulsed field.

  19. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

    2015-01-01

    To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Multicentre randomised controlled equivalence trial. 15 hospitals in the Netherlands. Women with an intermediate to high obstetric risk with an

  20. Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia : a randomised equivalence trial

    NARCIS (Netherlands)

    Logtenberg, Slm; Oude Rengerink, K; Verhoeven, C J; Freeman, L M; van den Akker, Esa; Godfried, M B; van Beek, E; Borchert, Owhm; Schuitemaker, N; van Woerkens, Ecsm; Hostijn, I; Middeldorp, J M; van der Post, J A; Mol, B W

    OBJECTIVE: To distinguish satisfaction with pain relief using remifentanil patient-controlled analgesia (RPCA) compared with epidural analgesia (EA) in low-risk labouring women. DESIGN: Randomised controlled equivalence trial. SETTING: Eighteen midwifery practices and six hospitals in the

  1. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M; Bloemenkamp, Kitty W; Franssen, Maureen T; Papatsonis, Dimitri N; Hajenius, Petra J; Hollmann, Markus W; Woiski, Mallory D; Porath, Martina; van den Berg, Hans J; van Beek, Erik; Borchert, Odette W H M; Schuitemaker, Nico; Sikkema, J Marko; Kuipers, A H M; Logtenberg, Sabine L M; van der Salm, Paulien C M; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M Elske; le Cessie, Saskia; van Lith, Jan M; Struys, Michel M; Mol, Ben Willem J; Dahan, Albert; Middeldorp, Johanna M; Oude Rengerink, K

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

  2. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Rengerink, Katrien Oude; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

    2015-01-01

    Objective To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Design Multicentre randomised controlled equivalence trial. Setting 15 hospitals in the Netherlands. Participants Women with an

  3. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, L.M.; Bloemenkamp, K.W.; Franssen, M.T.; Papatsonis, D.N.; Hajenius, P.J.; Hollmann, M.W.; Woiski, M.D.; Porath, M.; Berg, H.J. van den; Beek, E. van; Borchert, O.W.; Schuitemaker, N.; Sikkema, J.M.; Kuipers, A.H.; Logtenberg, S.L.; Salm, P.C. van der; Oude Rengerink, K.; Lopriore, E.; Akker-van Marle, M.E. van den; Cessie, S. le; Lith, J.M. van; Struys, M.M.; Mol, B.W.; Dahan, A; Middeldorp, J.M.

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

  4. Predictors of Missed Research Appointments in a Randomized Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Stéphanie J.E. Becker

    2014-09-01

     Younger patients with no college education, who believe their health can be controlled, are more likely to miss a research appointment when enrolled in a randomized placebo injection-controlled trial

  5. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

    DEFF Research Database (Denmark)

    Savović, J; Jones, He; Altman, Dg

    2012-01-01

    The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

  6. Temperature Field-Wind Velocity Field Optimum Control of Greenhouse Environment Based on CFD Model

    Directory of Open Access Journals (Sweden)

    Yongbo Li

    2014-01-01

    Full Text Available The computational fluid dynamics technology is applied as the environmental control model, which can include the greenhouse space. Basic environmental factors are set to be the control objects, the field information is achieved via the division of layers by height, and numerical characteristics of each layer are used to describe the field information. Under the natural ventilation condition, real-time requirements, energy consumption, and distribution difference are selected as index functions. The optimization algorithm of adaptive simulated annealing is used to obtain optimal control outputs. A comparison with full-open ventilation shows that the whole index can be reduced at 44.21% and found that a certain mutual exclusiveness exists between the temperature and velocity field in the optimal course. All the results indicate that the application of CFD model has great advantages to improve the control accuracy of greenhouse.

  7. Using a Control System Ethernet Network as a Field Bus

    CERN Document Server

    De Van, William R; Lawson, Gregory S; Wagner, William H; Wantland, David M; Williams, Ernest

    2005-01-01

    A major component of a typical accelerator distributed control system (DCS) is a dedicated, large-scale local area communications network (LAN). The SNS EPICS-based control system uses a LAN based on the popular IEEE-802.3 set of standards (Ethernet). Since the control system network infrastructure is available throughout the facility, and since Ethernet-based controllers are readily available, it is tempting to use the control system LAN for "fieldbus" communications to low-level control devices (e.g. vacuum controllers; remote I/O). These devices may or may not be compatible with the high-level DCS protocols. This paper presents some of the benefits and risks of combining high-level DCS communications with low-level "field bus" communications on the same network, and describes measures taken at SNS to promote compatibility between devices connected to the control system network.

  8. Efficacy of Exercise for Menopausal Symptoms: A Randomized Controlled Trial

    Science.gov (United States)

    Sternfeld, Barbara; Guthrie, Katherine A.; Ensrud, Kristine E.; LaCroix, Andrea Z.; Larson, Joseph C.; Dunn, Andrea L.; Anderson, Garnet L.; Seguin, Rebecca A.; Carpenter, Janet S.; Newton, Katherine M.; Reed, Susan D.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Roberts, Melanie; Caan, Bette J.

    2013-01-01

    OBJECTIVE To determine efficacy of exercise training for alleviating vasomotor and other menopausal symptoms. METHODS Late-peri and post-menopausal, sedentary women with frequent vasomotor symptoms (VMS) participated in a randomized controlled trial conducted at three sites: 106 to exercise and 142 to usual activity. The exercise intervention consisted of individual, facility-based aerobic exercise training 3 times/week for 12 weeks. VMS frequency and bother were recorded on daily diaries at baseline and weeks 6 and 12. Intent to treat analyses compared between group differences in changes in VMS frequency and bother, sleep symptoms (Insomnia Severity Index, Pittsburgh Sleep Quality Index) and mood (Patient Health Questionnaire-8 and Generalized Anxiety Disorder-7 questionnaire). RESULTS At the end of week 12, changes in VMS frequency in the exercise group (mean change of −2.4/day, 95% CI −3.0, −1.7) and VMS bother (mean change of −0.5 on a 4 point scale, 95% CI −0.6, −0.4) were not significantly different from those in the control group (−2.6 VMS/day, 95% CI −3.2, −2.0, p=0.43; −0.5 points, 95% CI −0.6, −0.4, p=0.75). The exercise group reported greater improvement in insomnia symptoms (p=0.03), subjective sleep quality (p=0.01), and depressive symptoms (p=0.04), but differences were small and not statistically significant when p values were adjusted for multiple comparisons. Results were similar when considering treatment-adherent women only. CONCLUSION These findings provide strong evidence that 12-weeks of moderate-intensity aerobic exercise does not alleviate VMS but may result in small improvements in sleep quality, insomnia and depression in midlife, sedentary women. PMID:23899828

  9. Online Adaptation and Over-Trial Learning in Macaque Visuomotor Control

    Science.gov (United States)

    Braun, Daniel A.; Aertsen, Ad; Paz, Rony; Vaadia, Eilon; Rotter, Stefan; Mehring, Carsten

    2011-01-01

    When faced with unpredictable environments, the human motor system has been shown to develop optimized adaptation strategies that allow for online adaptation during the control process. Such online adaptation is to be contrasted to slower over-trial learning that corresponds to a trial-by-trial update of the movement plan. Here we investigate the interplay of both processes, i.e., online adaptation and over-trial learning, in a visuomotor experiment performed by macaques. We show that simple non-adaptive control schemes fail to perform in this task, but that a previously suggested adaptive optimal feedback control model can explain the observed behavior. We also show that over-trial learning as seen in learning and aftereffect curves can be explained by learning in a radial basis function network. Our results suggest that both the process of over-trial learning and the process of online adaptation are crucial to understand visuomotor learning. PMID:21720526

  10. Guidelines for controlled trials of drugs in tension-type headache: second edition

    DEFF Research Database (Denmark)

    Bendtsen, L; Bigal, M E; Cerbo, R

    2010-01-01

    and chronic tension-type headache have been published, providing new information on trial methodology for this disorder. Furthermore, the classification of the headaches, including tension-type headache, has been revised. These developments support the need for also revising the guidelines for drug treatments......The Clinical Trials Subcommittee of the International Headache Society published its first edition of the guidelines on controlled trials of drugs in tension-type headache in 1995. These aimed 'to improve the quality of controlled clinical trials in tension-type headache', because 'good quality...... controlled trials are the only way to convincingly demonstrate the efficacy of a drug, and form the basis for international agreement on drug therapy'. The Committee published similar guidelines for clinical trials in migraine and cluster headache. Since 1995 several studies on the treatment of episodic...

  11. Sentence retrieval for abstracts of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Chung Grace Y

    2009-02-01

    Full Text Available Abstract Background The practice of evidence-based medicine (EBM requires clinicians to integrate their expertise with the latest scientific research. But this is becoming increasingly difficult with the growing numbers of published articles. There is a clear need for better tools to improve clinician's ability to search the primary literature. Randomized clinical trials (RCTs are the most reliable source of evidence documenting the efficacy of treatment options. This paper describes the retrieval of key sentences from abstracts of RCTs as a step towards helping users find relevant facts about the experimental design of clinical studies. Method Using Conditional Random Fields (CRFs, a popular and successful method for natural language processing problems, sentences referring to Intervention, Participants and Outcome Measures are automatically categorized. This is done by extending a previous approach for labeling sentences in an abstract for general categories associated with scientific argumentation or rhetorical roles: Aim, Method, Results and Conclusion. Methods are tested on several corpora of RCT abstracts. First structured abstracts with headings specifically indicating Intervention, Participant and Outcome Measures are used. Also a manually annotated corpus of structured and unstructured abstracts is prepared for testing a classifier that identifies sentences belonging to each category. Results Using CRFs, sentences can be labeled for the four rhetorical roles with F-scores from 0.93–0.98. This outperforms the use of Support Vector Machines. Furthermore, sentences can be automatically labeled for Intervention, Participant and Outcome Measures, in unstructured and structured abstracts where the section headings do not specifically indicate these three topics. F-scores of up to 0.83 and 0.84 are obtained for Intervention and Outcome Measure sentences. Conclusion Results indicate that some of the methodological elements of RCTs are

  12. Communication: Control of chemical reactions using electric field gradients

    Energy Technology Data Exchange (ETDEWEB)

    Deshmukh, Shivaraj D.; Tsori, Yoav, E-mail: tsori@bgu.ac.il [Department of Chemical Engineering, Ben-Gurion University of the Negev, Beer-Sheva 84105 (Israel)

    2016-05-21

    We examine theoretically a new idea for spatial and temporal control of chemical reactions. When chemical reactions take place in a mixture of solvents, an external electric field can alter the local mixture composition, thereby accelerating or decelerating the rate of reaction. The spatial distribution of electric field strength can be non-trivial and depends on the arrangement of the electrodes producing it. In the absence of electric field, the mixture is homogeneous and the reaction takes place uniformly in the reactor volume. When an electric field is applied, the solvents separate and the reactants are concentrated in the same phase or separate to different phases, depending on their relative miscibility in the solvents, and this can have a large effect on the kinetics of the reaction. This method could provide an alternative way to control runaway reactions and to increase the reaction rate without using catalysts.

  13. Communication: Control of chemical reactions using electric field gradients.

    Science.gov (United States)

    Deshmukh, Shivaraj D; Tsori, Yoav

    2016-05-21

    We examine theoretically a new idea for spatial and temporal control of chemical reactions. When chemical reactions take place in a mixture of solvents, an external electric field can alter the local mixture composition, thereby accelerating or decelerating the rate of reaction. The spatial distribution of electric field strength can be non-trivial and depends on the arrangement of the electrodes producing it. In the absence of electric field, the mixture is homogeneous and the reaction takes place uniformly in the reactor volume. When an electric field is applied, the solvents separate and the reactants are concentrated in the same phase or separate to different phases, depending on their relative miscibility in the solvents, and this can have a large effect on the kinetics of the reaction. This method could provide an alternative way to control runaway reactions and to increase the reaction rate without using catalysts.

  14. FIT for FUNCTION: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Richardson, Julie; Tang, Ada; Guyatt, Gordon; Thabane, Lehana; Xie, Feng; Sahlas, Demetrios; Hart, Robert; Fleck, Rebecca; Hladysh, Genevieve; Macrae, Louise

    2018-01-15

    The current state of evidence suggests that community-based exercise programs are beneficial in improving impairment, function, and health status, and are greatly needed for persons with stroke. However, limitations of these studies include risk of bias, feasibility, and cost issues. This single-blinded, randomized controlled trial (RCT) of 216 participants with stroke will compare the effectiveness of a 12-week YMCA community-based wellness program (FIT for FUNCTION) specifically designed for community-dwelling persons with stroke to persons who receive a standard YMCA membership. The primary outcome will be community reintegration using the Reintegration to Normal Living Index at 12 and 24 weeks. Secondary outcomes include measurement of physical activity level using the Rapid Assessment of Physical Activity and accelerometry; balance using the Berg Balance Scale; lower extremity function using the Short Physical Performance Battery; exercise capacity using the 6-min walk test; grip strength and isometric knee extension strength using hand held dynamometry; and health-related quality of life using the European Quality of Life 5-Dimension Questionnaire. We are also assessing cardiovascular health and lipids; glucose and inflammatory markers will be collected following 12-h fast for total cholesterol, insulin, glucose, and glycated hemoglobin. Self-efficacy for physical activity will be assessed with a single question and self-efficacy for managing chronic disease will be assessed using the Stanford 6-item Scale. The Patient Activation Measure will be used to assess the patient's level of knowledge, skill, and confidence for self-management. Healthcare utilization and costs will be evaluated. Group, time, and group × time interaction effects will be estimated using generalized linear models for continuous variables, including relevant baseline variables as covariates in the analysis that differ appreciably between groups at baseline. Cost data will be treated

  15. When ethics constrains clinical research: trial design of control arms in "greater than minimal risk" pediatric trials.

    Science.gov (United States)

    de Melo-Martín, Inmaculada; Sondhi, Dolan; Crystal, Ronald G

    2011-09-01

    For more than three decades clinical research in the United States has been explicitly guided by the idea that ethical considerations must be central to research design and practice. In spite of the centrality of this idea, attempting to balance the sometimes conflicting values of advancing scientific knowledge and protecting human subjects continues to pose challenges. Possible conflicts between the standards of scientific research and those of ethics are particularly salient in relation to trial design. Specifically, the choice of a control arm is an aspect of trial design in which ethical and scientific issues are deeply entwined. Although ethical quandaries related to the choice of control arms may arise when conducting any type of clinical trials, they are conspicuous in early phase gene transfer trials that involve highly novel approaches and surgical procedures and have children as the research subjects. Because of children's and their parents' vulnerabilities, in trials that investigate therapies for fatal, rare diseases affecting minors, the scientific and ethical concerns related to choosing appropriate controls are particularly significant. In this paper we use direct gene transfer to the central nervous system to treat late infantile neuronal ceroid lipofuscinosis to illustrate some of these ethical issues and explore possible solutions to real and apparent conflicts between scientific and ethical considerations.

  16. Statistical analysis of nitrous oxide emission factors from pastoral agriculture field trials conducted in New Zealand

    International Nuclear Information System (INIS)

    Kelliher, F.M.; Cox, N.; Weerden, T.J. van der; Klein, C.A.M. de; Luo, J.; Cameron, K.C.; Di, H.J.; Giltrap, D.; Rys, G.

    2014-01-01

    Between 11 May 2000 and 31 January 2013, 185 field trials were conducted across New Zealand to measure the direct nitrous oxide (N 2 O) emission factors (EF) from nitrogen (N) sources applied to pastoral soils. The log(EF) data were analysed statistically using a restricted maximum likelihood (REML) method. To estimate mean EF values for each N source, best linear unbiased predictors (BLUPs) were calculated. For lowland soils, mean EFs for dairy cattle urine and dung, sheep urine and dung and urea fertiliser were 1.16 ± 0.19% and 0.23 ± 0.05%, 0.55 ± 0.19% and 0.08 ± 0.02% and 0.48 ± 0.13%, respectively, each significantly different from one another (p 12°, mean EFs were significantly lower. Thus, urine and dung EFs should be disaggregated for sheep and cattle as well as accounting for terrain. -- Highlights: • Nitrous oxide emission factors (EFs) for pastoral soils measured in 185 field trials. • For lowland, the mean (±standard error) urea nitrogen fertiliser EF was 0.5 ± 0.1%. • For lowland, mean dairy cattle urine and dung EFs were 1.2 and 0.2%, respectively. • For lowland, mean sheep urine and dung EFs were 0.6 and 0.1%, respectively. • For pastoral soils in terrain with slopes >12°, mean EFs were significantly lower. -- From 185 field trials, mean nitrous oxide emission factors for pastoral soils were 0.1% for sheep dung up to 1.2% for dairy cattle urine, while that for urea fertiliser was 0.5%

  17. Generation Of Unipolar Field For The Control Of Charges

    Directory of Open Access Journals (Sweden)

    Barnabas Oluwaseyi Alabi

    2017-10-01

    Full Text Available Electric charge is the property of a matter that allow for electric and magnetic forces interaction. These charges can be controlled by unipolar electromagnetic field. In this study such unipolar field that can propagate was generated. This unipolar electromagnetic field was simulated and tested for propagation. To produce a propagating unipolar magnetic field a time-varying unipolar electric current generator was considered. The model considered was simulated in the National Instruments Multisim windows application environment. The generated electric voltage waveform was viewed via the output grapher of the application. Various loads were connected to ensure consistency in the unipolar waveform for different load value on the generator. The result obtained showed that a unipolar field which could propagate can be achievable only when the signal involved was properly rectified. After rectification however the desired waveform and signal was produced. The test for propagation was done using a core of iron and a small solenoid connected to the rectified output and the field produced was magnetic this attracted a metal clip 1.0 cm away and a larger core attracted a hammer from around 10.0 cm away. The study concluded that a propagating magnetic field useful for the control of charges can be generated if the signal involved is made to be unipolar in nature.

  18. Large-scale building integrated photovoltaics field trial. First technical report - installation phase

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2004-07-01

    This report summarises the results of the first eighteen months of the Large-Scale Building Integrated Photovoltaic Field Trial focussing on technical aspects. The project aims included increasing awareness and application of the technology, raising the UK capabilities in application of the technology, and assessing the potential for building integrated photovoltaics (BIPV). Details are given of technology choices; project organisation, cost, and status; and the evaluation criteria. Installations of BIPV described include University buildings, commercial centres, and a sports stadium, wildlife park, church hall, and district council building. Lessons learnt are discussed, and a further report covering monitoring aspects is planned.

  19. Demonstration and field trial of a resilient hybrid NG-PON test-bed

    Science.gov (United States)

    Prat, Josep; Polo, Victor; Schrenk, Bernhard; Lazaro, Jose A.; Bonada, Francesc; Lopez, Eduardo T.; Omella, Mireia; Saliou, Fabienne; Le, Quang T.; Chanclou, Philippe; Leino, Dmitri; Soila, Risto; Spirou, Spiros; Costa, Liliana; Teixeira, Antonio; Tosi-Beleffi, Giorgio M.; Klonidis, Dimitrios; Tomkos, Ioannis

    2014-10-01

    A multi-layer next generation PON prototype has been built and tested, to show the feasibility of extended hybrid DWDM/TDM-XGPON FTTH networks with resilient optically-integrated ring-trees architecture, supporting broadband multimedia services. It constitutes a transparent common platform for the coexistence of multiple operators sharing the optical infrastructure of the central metro ring, passively combining the access and the metropolitan network sections. It features 32 wavelength connections at 10 Gbps, up to 1000 users distributed in 16 independent resilient sub-PONs over 100 km. This paper summarizes the network operation, demonstration and field trial results.

  20. Influence of vitamin E supplementation on glycaemic control: a meta-analysis of randomised controlled trials.

    Directory of Open Access Journals (Sweden)

    Renfan Xu

    Full Text Available Observational studies have revealed that higher serum vitamin E concentrations and increased vitamin E intake and vitamin E supplementation are associated with beneficial effects on glycaemic control in type 2 diabetes mellitus (T2DM. However, whether vitamin E supplementation exerts a definitive effect on glycaemic control remains unclear. This article involves a meta-analysis of randomised controlled trials of vitamin E to better characterise its impact on HbA1c, fasting glucose and fasting insulin. PubMed, EMBASE and the Cochrane Library were electronically searched from the earliest possible date through April 2013 for all relevant studies. Weighted mean difference (WMD was calculated for net changes using fixed-effects or random-effects models. Standard methods for assessing statistical heterogeneity and publication bias were used. Fourteen randomised controlled trials involving individual data on 714 subjects were collected in this meta-analysis. Increased vitamin E supplementation did not result in significant benefits in glycaemic control as measured by reductions in HbA1c, fasting glucose and fasting insulin. Subgroup analyses revealed a significant reduction in HbA1c (-0.58%, 95% CI -0.83 to -0.34 and fasting insulin (-9.0 pmol/l, 95% CI -15.90 to -2.10 compared with controls in patients with low baseline vitamin E status. Subgroup analyses also demonstrated that the outcomes may have been influenced by the vitamin E dosage, study duration, ethnic group, serum HbA1c concentration, and fasting glucose control status. In conclusion, there is currently insufficient evidence to support a potential beneficial effect of vitamin E supplementation on improvements of HbA1c and fasting glucose and insulin concentrations in subjects with T2DM.

  1. Influence of vitamin E supplementation on glycaemic control: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Xu, Renfan; Zhang, Shasha; Tao, Anyu; Chen, Guangzhi; Zhang, Muxun

    2014-01-01

    Observational studies have revealed that higher serum vitamin E concentrations and increased vitamin E intake and vitamin E supplementation are associated with beneficial effects on glycaemic control in type 2 diabetes mellitus (T2DM). However, whether vitamin E supplementation exerts a definitive effect on glycaemic control remains unclear. This article involves a meta-analysis of randomised controlled trials of vitamin E to better characterise its impact on HbA1c, fasting glucose and fasting insulin. PubMed, EMBASE and the Cochrane Library were electronically searched from the earliest possible date through April 2013 for all relevant studies. Weighted mean difference (WMD) was calculated for net changes using fixed-effects or random-effects models. Standard methods for assessing statistical heterogeneity and publication bias were used. Fourteen randomised controlled trials involving individual data on 714 subjects were collected in this meta-analysis. Increased vitamin E supplementation did not result in significant benefits in glycaemic control as measured by reductions in HbA1c, fasting glucose and fasting insulin. Subgroup analyses revealed a significant reduction in HbA1c (-0.58%, 95% CI -0.83 to -0.34) and fasting insulin (-9.0 pmol/l, 95% CI -15.90 to -2.10) compared with controls in patients with low baseline vitamin E status. Subgroup analyses also demonstrated that the outcomes may have been influenced by the vitamin E dosage, study duration, ethnic group, serum HbA1c concentration, and fasting glucose control status. In conclusion, there is currently insufficient evidence to support a potential beneficial effect of vitamin E supplementation on improvements of HbA1c and fasting glucose and insulin concentrations in subjects with T2DM.

  2. Rotor Field Oriented Control with adaptive Iron Loss Compensation

    DEFF Research Database (Denmark)

    Rasmussen, Henrik; Vadstrup, P.; Børsting, H.

    1999-01-01

    It is well known from the literature that iron loses in an induction motor implies field angle estimation errors and hence detuning problems. In this paper a new method for estimating the iron loss resistor in an induction motor is presented. The method is based on a traditional dynamic model...... controlled in a Field Oriented Control scheme. This deviation is used to force a MIT-rule based adaptive estimator. An adaptive compensator containing the developed estimator is introduced and verified by simulations and tested by real time experiments....

  3. Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.

    Directory of Open Access Journals (Sweden)

    Norio Sugawara

    Full Text Available Although the use of placebo in clinical trials of schizophrenia patients is controversial because of medical and ethical concerns, placebo-controlled clinical trials are commonly used in the licensing of new drugs.The objective of this study was to assess the attitudes toward placebo-controlled clinical trials among patients with schizophrenia in Japan.Using a cross-sectional design, we recruited patients (n = 251 aged 47.7±13.2 (mean±SD with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who were admitted to six psychiatric hospitals from December 2013 to March 2014. We employed a 14-item questionnaire specifically developed to survey patients' attitudes toward placebo-controlled clinical trials.The results indicated that 33% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for improvement of disease, a guarantee of hospital treatment continuation, and encouragement by family or friends were associated with the willingness to participate in such trials, whereas a belief of additional time required for medical examinations was associated with non-participation.Fewer than half of the respondents stated that they would be willing to participate in placebo-controlled clinical trials. Therefore, interpreting the results from placebo-controlled clinical trials could be negatively affected by selection bias.

  4. A new controller for the JET error field correction coils

    International Nuclear Information System (INIS)

    Zanotto, L.; Sartori, F.; Bigi, M.; Piccolo, F.; De Benedetti, M.

    2005-01-01

    This paper describes the hardware and the software structure of a new controller for the JET error field correction coils (EFCC) system, a set of ex-vessel coils that recently replaced the internal saddle coils. The EFCC controller has been developed on a conventional VME hardware platform using a new software framework, recently designed for real-time applications at JET, and replaces the old disruption feedback controller increasing the flexibility and the optimization of the system. The use of conventional hardware has required a particular effort in designing the software part in order to meet the specifications. The peculiarities of the new controller will be highlighted, such as its very useful trigger logic interface, which allows in principle exploring various error field experiment scenarios

  5. Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial

    Science.gov (United States)

    Macedo, Luciana G; Latimer, Jane; Maher, Chris G; Hodges, Paul W; Nicholas, Michael; Tonkin, Lois; McAuley, James H; Stafford, Ryan

    2008-01-01

    Background Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25–50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient. Methods This paper describes the protocol of a randomised clinical trial comparing the effects of motor control exercises with a graded activity program in the treatment of chronic non specific low back pain. Further analysis will identify clinical features that may predict a patient's response to each treatment. One hundred and seventy two participants will be randomly allocated to receive either a program of motor control exercises or graded activity. Measures of outcome will be obtained at 2, 6 and 12 months after randomisation. The primary outcomes are: pain (average pain intensity over the last week) and function (patient-specific functional scale) at 2 and 6 months. Potential treatment effect modifiers will be measured at baseline. Discussion This trial will not only evaluate which exercise approach is more effective in general for patients will chronic low back pain, but will also determine which exercise approach is best for an individual patient. Trial registration number ACTRN12607000432415 PMID:18454877

  6. Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    McAuley James H

    2008-05-01

    Full Text Available Abstract Background Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25–50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient. Methods This paper describes the protocol of a randomised clinical trial comparing the effects of motor control exercises with a graded activity program in the treatment of chronic non specific low back pain. Further analysis will identify clinical features that may predict a patient's response to each treatment. One hundred and seventy two participants will be randomly allocated to receive either a program of motor control exercises or graded activity. Measures of outcome will be obtained at 2, 6 and 12 months after randomisation. The primary outcomes are: pain (average pain intensity over the last week and function (patient-specific functional scale at 2 and 6 months. Potential treatment effect modifiers will be measured at baseline. Discussion This trial will not only evaluate which exercise approach is more effective in general for patients will chronic low back pain, but will also determine which exercise approach is best for an individual patient. Trial registration number ACTRN12607000432415

  7. Generalisability of an online randomised controlled trial: an empirical analysis.

    Science.gov (United States)

    Wang, Cheng; Mollan, Katie R; Hudgens, Michael G; Tucker, Joseph D; Zheng, Heping; Tang, Weiming; Ling, Li

    2018-02-01

    Investigators increasingly use online methods to recruit participants for randomised controlled trials (RCTs). However, the extent to which participants recruited online represent populations of interest is unknown. We evaluated how generalisable an online RCT sample is to men who have sex with men in China. Inverse probability of sampling weights (IPSW) and the G-formula were used to examine the generalisability of an online RCT using model-based approaches. Online RCT data and national cross-sectional study data from China were analysed to illustrate the process of quantitatively assessing generalisability. The RCT (identifier NCT02248558) randomly assigned participants to a crowdsourced or health marketing video for promotion of HIV testing. The primary outcome was self-reported HIV testing within 4 weeks, with a non-inferiority margin of -3%. In the original online RCT analysis, the estimated difference in proportions of HIV tested between the two arms (crowdsourcing and health marketing) was 2.1% (95% CI, -5.4% to 9.7%). The hypothesis that the crowdsourced video was not inferior to the health marketing video to promote HIV testing was not demonstrated. The IPSW and G-formula estimated differences were -2.6% (95% CI, -14.2 to 8.9) and 2.7% (95% CI, -10.7 to 16.2), with both approaches also not establishing non-inferiority. Conducting generalisability analysis of an online RCT is feasible. Examining the generalisability of online RCTs is an important step before an intervention is scaled up. NCT02248558. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  8. Rural providers’ access to online resources: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jonathan D. Eldredge

    2016-01-01

    Full Text Available Objective: The research determined the usage and satisfaction levels with one of two point-of-care (PoC resources among health care providers in a rural state. Methods: In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants’ attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA, paired t tests, and Cohen’s d statistic to compare pre- and post-study effects sizes. Results: Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to ‘‘about right amounts of information’’ at the completion of the study. DynaMed users reported a Cohen’s d increase of þ1.50 compared to AccessMedicine users’ reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen’s d. Conclusion: Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine.

  9. Dextrose Prolotherapy for Knee Osteoarthritis: A Randomized Controlled Trial

    Science.gov (United States)

    Rabago, David; Patterson, Jeffrey J.; Mundt, Marlon; Kijowski, Richard; Grettie, Jessica; Segal, Neil A.; Zgierska, Aleksandra

    2013-01-01

    PURPOSE Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis. METHODS Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used. RESULTS No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events. CONCLUSIONS Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises. PMID:23690322

  10. Rural providers' access to online resources: a randomized controlled trial

    Science.gov (United States)

    Hall, Laura J.; McElfresh, Karen R.; Warner, Teddy D.; Stromberg, Tiffany L.; Trost, Jaren; Jelinek, Devin A.

    2016-01-01

    Objective The research determined the usage and satisfaction levels with one of two point-of-care (PoC) resources among health care providers in a rural state. Methods In this randomized controlled trial, twenty-eight health care providers in rural areas were stratified by occupation and region, then randomized into either the DynaMed or the AccessMedicine study arm. Study participants were physicians, physician assistants, and nurses. A pre- and post-study survey measured participants' attitudes toward different information resources and their information-seeking activities. Medical student investigators provided training and technical support for participants. Data analyses consisted of analysis of variance (ANOVA), paired t tests, and Cohen's d statistic to compare pre- and post-study effects sizes. Results Participants in both the DynaMed and the AccessMedicine arms of the study reported increased satisfaction with their respective PoC resource, as expected. Participants in both arms also reported that they saved time in finding needed information. At baseline, both arms reported too little information available, which increased to “about right amounts of information” at the completion of the study. DynaMed users reported a Cohen's d increase of +1.50 compared to AccessMedicine users' reported use of 0.82. DynaMed users reported d2 satisfaction increases of 9.48 versus AccessMedicine satisfaction increases of 0.59 using a Cohen's d. Conclusion Participants in the DynaMed arm of the study used this clinically oriented PoC more heavily than the users of the textbook-based AccessMedicine. In terms of user satisfaction, DynaMed users reported higher levels of satisfaction than the users of AccessMedicine. PMID:26807050

  11. ASSESSMENT OF AMLODIPINE ANTIHYPERTENSIVE EFFECT HOMOGENEITY IN CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    V. M. Gorbunov

    2016-01-01

    Full Text Available Aim. To compare influence of amlodipine and spirapril on ambulatory blood pressure profile, including antihypertensive effect smoothness in patients with arterial hypertension (HT.Methods. 39 patients (aged 53,7±10,0 y.o. with HT were included in the open, randomized, cross-over study, 30 patients completed study. The duration of every therapies was 4 weeks, initial control period and wash-out period between therapies lasted 1 week. The initial daily dose of amlodipine was 5 mg, standard dose of spirapril (6 mg/daily was not changed during the trial. After 1-2 weeks of treatment amlodipine dose was increased up to 10 mg/daily as well as dihydrochlorothiazide was added, if necessary. Ambulatory blood pressure monitoring (ABPM was performed initially and at the end of both therapies.Results. Both drugs demonstrated good antihypertensive effect according to ABPM data. Decrease of systolic/diastolic blood pressure was 11,2±1,8/7,6±1,2 mm Hg in amlodipine therapy and 10,0±1,8/7,1±1,2 in spirapril therapy (p<0,0001. The smoothness indexes (SI were 0,65/0,45 and 0,55/0,45, respectively, differences between two therapies were not significant. However the individual analysis of the SI distribution (with SI=0,5 as a satisfactory criterion, showed that antihypertensive effect smoothness is better in amlodipine therapy than this in spirapril one.Conclusion. Amlodipine has prominent as well as smooth antihypertensive effect, that gives it advantages in the long-term antihypertensive therapy.

  12. Distributed acoustic sensing technique and its field trial in SAGD well

    Science.gov (United States)

    Han, Li; He, Xiangge; Pan, Yong; Liu, Fei; Yi, Duo; Hu, Chengjun; Zhang, Min; Gu, Lijuan

    2017-10-01

    Steam assisted gravity drainage (SAGD) is a very promising way for the development of heavy oil, extra heavy oil and tight oil reservoirs. Proper monitoring of the SAGD operations is essential to avoid operational issues and improve efficiency. Among all the monitoring techniques, micro-seismic monitoring and related interpretation method can give useful information about the steam chamber development and has been extensively studied. Distributed acoustic sensor (DAS) based on Rayleigh backscattering is a newly developed technique that can measure acoustic signal at all points along the sensing fiber. In this paper, we demonstrate a DAS system based on dual-pulse heterodyne demodulation technique and did field trial in SAGD well located in Xinjiang Oilfield, China. The field trail results validated the performance of the DAS system and indicated its applicability in steam-chamber monitoring and hydraulic monitoring.

  13. First field trial of a transmissible recombinant vaccine against myxomatosis and rabbit hemorrhagic disease.

    Science.gov (United States)

    Torres, J M; Sánchez, C; Ramírez, M A; Morales, M; Bárcena, J; Ferrer, J; Espuña, E; Pagès-Manté, A; Sánchez-Vizcaíno, J M

    2001-08-14

    As a novel approach for immunisation of wild rabbits, we have recently developed a transmissible vaccine against myxomatosis and rabbit hemorrhagic disease (RHD) based on a recombinant myxoma virus (MV) expressing the RHDV capsid protein [J. Virol. 74 (2000) 1114]. The efficacy and safety of the vaccine have been extensively evaluated under laboratory conditions. In this study, we report the first limited field trial of the candidate vaccine that was undertaken in an island of 34 Has containing a population of around 300 rabbits. Following administration by the subcutaneous route to 76 rabbits, the vaccine induced specific antibody responses against both myxomatosis and RHDV in all the inoculated rabbits. Furthermore, the recombinant virus exhibited a limited horizontal transmission capacity, promoting seroconversion of around 50% of the uninoculated rabbit population. No evidence of undesirable effects due to the recombinant virus field release was detected.

  14. Field trials of the phenomena of concern for psychiatric/mental health nursing: proposed methodology.

    Science.gov (United States)

    Wilson, H S

    1989-10-01

    An important step in the development of the American Nurses' Association (ANA) Task Force's Classification of Phenomena of Concern for Psychiatric/Mental Health Nursing is a plan for conducting field trials to determine interrater diagnostic reliability using the classification system. The ANA Task Force identified field testing as stage two in a three-stage process for completion of our work. In this article, we identify methodologic directions that will allow us to answer two important questions. First, what is the interrater reliability of the system of psychiatric nursing diagnoses when applied to clients by psychiatric/mental health nurse clinicians in their practice, and second, how do the clinicians who use this system view its usefulness for planning and evaluating nursing care?

  15. A ferrofluid based artificial tactile sensor with magnetic field control

    Energy Technology Data Exchange (ETDEWEB)

    Volkova, T.I., E-mail: tatiana.volkova@tu-ilmenau.de [Technical Mechanics Group, Faculty of Mechanical Engineering, Technische Universität Ilmenau, Ilmenau D-98684 (Germany); Böhm, V., E-mail: valter.boehm@tu-ilmenau.de [Technical Mechanics Group, Faculty of Mechanical Engineering, Technische Universität Ilmenau, Ilmenau D-98684 (Germany); Naletova, V.A., E-mail: naletova@imec.msu.ru [Faculty of Mechanics and Mathematics, Lomonosov Moscow State University, 119991 Moscow (Russian Federation); Kaufhold, T., E-mail: tobias.kaufhold@tu-ilmenau.de [Technical Mechanics Group, Faculty of Mechanical Engineering, Technische Universität Ilmenau, Ilmenau D-98684 (Germany); Becker, F., E-mail: felix.becker@tu-ilmenau.de [Technical Mechanics Group, Faculty of Mechanical Engineering, Technische Universität Ilmenau, Ilmenau D-98684 (Germany); Zeidis, I., E-mail: igor.zeidis@tu-ilmenau.de [Technical Mechanics Group, Faculty of Mechanical Engineering, Technische Universität Ilmenau, Ilmenau D-98684 (Germany); Zimmermann, K., E-mail: klaus.zimmermann@tu-ilmenau.de [Technical Mechanics Group, Faculty of Mechanical Engineering, Technische Universität Ilmenau, Ilmenau D-98684 (Germany)

    2017-06-01

    The paper deals with a tactile sensor inspired by biological hairs of mammals. The working principle is based on the effect of the magnetic force exerted on a paramagnetic body submerged into a ferrofluid volume under the influence of a nonuniform magnetic field. The deflection of the sensor's rod caused by external mechanical stimuli may be unambiguously identified by the distortion of the magnetic field, which occurs due to the motion of the attached body in the ferrofluid. The magnetic force acting on the body is evaluated experimentally and theoretically for the nonuniform magnetic field of a permanent magnet. The controlled oscillations of the rod are realised by applying a nonuniform magnetic field of periodically altering direction. - Highlights: • A design approach of a tactile sensor inspired by special mammalian hairs is presented. • The working principle is based on magnetic properties of a ferrofluid in magnetic fields. • The magnetic force acting on a body submerged into a ferrofluid volume is evaluated. • External mechanical stimuli may be identified by the distortion of the magnetic field. • The controlled whisking-like oscillations of the sensor's rod are realised experimentally.

  16. A ferrofluid based artificial tactile sensor with magnetic field control

    International Nuclear Information System (INIS)

    Volkova, T.I.; Böhm, V.; Naletova, V.A.; Kaufhold, T.; Becker, F.; Zeidis, I.; Zimmermann, K.

    2017-01-01

    The paper deals with a tactile sensor inspired by biological hairs of mammals. The working principle is based on the effect of the magnetic force exerted on a paramagnetic body submerged into a ferrofluid volume under the influence of a nonuniform magnetic field. The deflection of the sensor's rod caused by external mechanical stimuli may be unambiguously identified by the distortion of the magnetic field, which occurs due to the motion of the attached body in the ferrofluid. The magnetic force acting on the body is evaluated experimentally and theoretically for the nonuniform magnetic field of a permanent magnet. The controlled oscillations of the rod are realised by applying a nonuniform magnetic field of periodically altering direction. - Highlights: • A design approach of a tactile sensor inspired by special mammalian hairs is presented. • The working principle is based on magnetic properties of a ferrofluid in magnetic fields. • The magnetic force acting on a body submerged into a ferrofluid volume is evaluated. • External mechanical stimuli may be identified by the distortion of the magnetic field. • The controlled whisking-like oscillations of the sensor's rod are realised experimentally.

  17. Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

    Directory of Open Access Journals (Sweden)

    Rahu Mati

    2008-08-01

    Full Text Available Abstract Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT, originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT on health services utilization. Results After EPHT recruited in 1999–2001 the Women's Health Initiative (WHI in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an (old drug for a new preventive indication? In preventive drug trials companies may

  18. Probe-Hole Field Emission Microscope System Controlled by Computer

    Science.gov (United States)

    Gong, Yunming; Zeng, Haishan

    1991-09-01

    A probe-hole field emission microscope system, controlled by an Apple II computer, has been developed and operated successfully for measuring the work function of a single crystal plane. The work functions on the clean W(100) and W(111) planes are measured to be 4.67 eV and 4.45 eV, respectively.

  19. Environmental Control Plan for the Industrial Hygiene Field Services Facility

    International Nuclear Information System (INIS)

    Donnelly, J.W.

    2000-01-01

    This environmental control plan is for the Hanford Site's Industrial Hygiene Field Services Facility, located in the 100-N Area. This facility is used for the maintenance and storage of respirators, respiratory equipment and testing, calibration and testing of industrial hygiene equipment, and asbestos fiber counting

  20. Evaluation of Kilifi epilepsy education programme: a randomized controlled trial.

    Science.gov (United States)

    Ibinda, Fredrick; Mbuba, Caroline K; Kariuki, Symon M; Chengo, Eddie; Ngugi, Anthony K; Odhiambo, Rachael; Lowe, Brett; Fegan, Greg; Carter, Julie A; Newton, Charles R

    2014-02-01

    The epilepsy treatment gap is largest in resource-poor countries. We evaluated the efficacy of a 1-day health education program in a rural area of Kenya. The primary outcome was adherence to antiepileptic drugs (AEDs) as measured by drug levels in the blood, and the secondary outcomes were seizure frequency and Kilifi Epilepsy Beliefs and Attitudes Scores (KEBAS). Seven hundred thirty-eight people with epilepsy (PWE) and their designated supporter were randomized to either the intervention (education) or nonintervention group. Data were collected at baseline and 1 year after the education intervention was administered to the intervention group. There were 581 PWE assessed at both time points. At the end of the study, 105 PWE from the intervention group and 86 from the nonintervention group gave blood samples, which were assayed for the most commonly used AEDs (phenobarbital, phenytoin, and carbamazepine). The proportions of PWE with detectable AED levels were determined using a standard blood assay method. The laboratory technicians conducting the assays were blinded to the randomization. Secondary outcomes were evaluated using questionnaires administered by trained field staff. Modified Poisson regression was used to investigate the factors associated with improved adherence (transition from nonoptimal AED level in blood at baseline to optimal levels at follow-up), reduced seizures, and improved KEBAS, which was done as a post hoc analysis. This trial is registered in ISRCTN register under ISRCTN35680481. There was no significant difference in adherence to AEDs based on detectable drug levels (odds ratio [OR] 1.46, 95% confidence interval [95% CI] 0.74-2.90, p = 0.28) or by self-reports (OR 1.00, 95% CI 0.71-1.40, p = 1.00) between the intervention and nonintervention group. The intervention group had significantly fewer beliefs about traditional causes of epilepsy, cultural treatment, and negative stereotypes than the nonintervention group. There was no

  1. A general method for handling missing binary outcome data in randomized controlled trials

    OpenAIRE

    Jackson, Dan; White, Ian R; Mason, Dan; Sutton, Stephen

    2014-01-01

    Aims The analysis of randomized controlled trials with incomplete binary outcome data is challenging. We develop a general method for exploring the impact of missing data in such trials, with a focus on abstinence outcomes. Design We propose a sensitivity analysis where standard analyses, which could include ‘missing = smoking’ and ‘last observation carried forward’, are embedded in a wider class of models. Setting We apply our general method to data from two smoking cessation trials. Partici...

  2. Behavioral insights and business taxation: Evidence from two randomized controlled trials

    OpenAIRE

    Biddle, Nicholas; Fels, Katja; Sinning, Mathias

    2017-01-01

    This paper presents the findings of two Randomized Controlled Trials (RCTs) that were conducted in collaboration with the Australian Taxation Office (ATO). The first trial tests the effect of changes to letters (timing, social norms, color, and provision of information about charitable donations) on response rates of businesses, the timing of payments and the amount of tax debt payments. The second trial consists of two parts. The first part aims to raise awareness of the relevance of tax deb...

  3. Participant recruitment into a randomised controlled trial of exercise therapy for people with multiple sclerosis

    OpenAIRE

    Carter, Anouska; Humphreys, Liam; Snowdon, Nicky; Sharrack, Basil; Daley, Amanda; Petty, Jane; Woodroofe, Nicola; Saxton, John

    2015-01-01

    Background The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame. Despite an increase in research into the benefits of exercise in people with multiple sclerosis (PwMS), no trial has reported detailed data on effective recruitment strategies for large-scale randomised controlled trials. The main purpose of this report is to provide a detailed outline of recruitment strategies, rates and estimated costs in the Exercise Intervent...

  4. Field trials of aquifer protection in longwall mining of shallow coal seams in China

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, D.S.; Fan, G.W.; Liu, Y.D.; Ma, L.Q. [State Key Laboratory of Coal Resource & Mine Safety, Xuzhou (China)

    2010-09-15

    The large-scale mining of shallow coal seams has a significant impact on the overlying aquifers and surface ecological environment. To protect the aquifers and maximize the coal resource recovery, field trials were undertaken during the operation of the LW32201 in Bulianta coal mine, Shendong, China. With a severely weathered rock (SWR) layer and two key strata (KS) in the overlying strata, aquifer protection in longwall mining (APLM) relies mainly on the rapid advance. In some localized zones, special measures should be taken to achieve the APLM, including lowering mining height, backfill and slurry injection. To further understand the mechanism and applicable conditions of the APLM and validate the effectiveness of the APLM, variation of the water table in the aquifer was observed as the longwall face passed through the zone. This paper also discusses the mechanism and basic requirements of the APLM and the relationship between the fall of the water table and the surface subsidence. The results of the field trials indicated that APLM in shallow coal seams could be successful under suitable conditions.

  5. An unattended verification station for UF6 cylinders: Field trial findings

    Science.gov (United States)

    Smith, L. E.; Miller, K. A.; McDonald, B. S.; Webster, J. B.; Zalavadia, M. A.; Garner, J. R.; Stewart, S. L.; Branney, S. J.; Todd, L. C.; Deshmukh, N. S.; Nordquist, H. A.; Kulisek, J. A.; Swinhoe, M. T.

    2017-12-01

    In recent years, the International Atomic Energy Agency (IAEA) has pursued innovative techniques and an integrated suite of safeguards measures to address the verification challenges posed by the front end of the nuclear fuel cycle. Among the unattended instruments currently being explored by the IAEA is an Unattended Cylinder Verification Station (UCVS), which could provide automated, independent verification of the declared relative enrichment, 235U mass, total uranium mass, and identification for all declared uranium hexafluoride cylinders in a facility (e.g., uranium enrichment plants and fuel fabrication plants). Under the auspices of the United States and European Commission Support Programs to the IAEA, a project was undertaken to assess the technical and practical viability of the UCVS concept. The first phase of the UCVS viability study was centered on a long-term field trial of a prototype UCVS system at a fuel fabrication facility. A key outcome of the study was a quantitative performance evaluation of two nondestructive assay (NDA) methods being considered for inclusion in a UCVS: Hybrid Enrichment Verification Array (HEVA), and Passive Neutron Enrichment Meter (PNEM). This paper provides a description of the UCVS prototype design and an overview of the long-term field trial. Analysis results and interpretation are presented with a focus on the performance of PNEM and HEVA for the assay of over 200 "typical" Type 30B cylinders, and the viability of an "NDA Fingerprint" concept as a high-fidelity means to periodically verify that material diversion has not occurred.

  6. Phytoremediation prospects of willow stands on contaminated sediment: a field trial

    International Nuclear Information System (INIS)

    Vervaeke, P.; Luyssaert, S.; Mertens, J.; Meers, E.; Tack, F.M.G.; Lust, N.

    2003-01-01

    A field trial indicated increased degradation of mineral oil in sediments planted with willow. - Establishing fast growing willow stands on land disposed contaminated dredged sediment can result in the revaluation of this material and opens possibilities for phytoremediation. A field trial was designed to assess the impact of planting a willow stand (Salix viminalis L. 'Orm') on the dissipation of organic contaminants (mineral oil and PAHs) in dredged sediment. In addition, the accumulation of heavy metals (Cd, Cu, Pb and Zn) in the biomass was determined. After 1.5 years, a significant decrease of 57% in the mineral oil concentration in the sediment planted with willow was observed. Degradation of mineral oil in sediment which was left fallow, was only 15%. The mineral oil degradation under willow was most pronounced (79%) in the root zone of the stand. In the sediment which was left fallow there was a significant reduction of the total PAH content by 32% compared with a 23% reduction in the planted sediment. The moderate and selective metal uptake, measured in this study, limits the prospects for phytoextraction of metals from dredged sediment

  7. Phytoremediation prospects of willow stands on contaminated sediment: a field trial

    Energy Technology Data Exchange (ETDEWEB)

    Vervaeke, P.; Luyssaert, S.; Mertens, J.; Meers, E.; Tack, F.M.G.; Lust, N

    2003-11-01

    A field trial indicated increased degradation of mineral oil in sediments planted with willow. - Establishing fast growing willow stands on land disposed contaminated dredged sediment can result in the revaluation of this material and opens possibilities for phytoremediation. A field trial was designed to assess the impact of planting a willow stand (Salix viminalis L. 'Orm') on the dissipation of organic contaminants (mineral oil and PAHs) in dredged sediment. In addition, the accumulation of heavy metals (Cd, Cu, Pb and Zn) in the biomass was determined. After 1.5 years, a significant decrease of 57% in the mineral oil concentration in the sediment planted with willow was observed. Degradation of mineral oil in sediment which was left fallow, was only 15%. The mineral oil degradation under willow was most pronounced (79%) in the root zone of the stand. In the sediment which was left fallow there was a significant reduction of the total PAH content by 32% compared with a 23% reduction in the planted sediment. The moderate and selective metal uptake, measured in this study, limits the prospects for phytoextraction of metals from dredged sediment.

  8. A critical appraisal of the reporting quality of published randomized controlled trials in the fall injuries.

    Science.gov (United States)

    Asghari Jafarabadi, Mohammad; Sadeghi-Bazrgani, Homayoun; Dianat, Iman

    2018-06-01

    To evaluate the quality of reporting in published randomized controlled trials (RTCs) in the field of fall injuries. The 188 RTCs published between 2001 and 2011, indexed in EMBASE and Medline databases were extracted through searching by appropriate keywords and EMTree classification terms. The evaluation trustworthiness was assured through parallel evaluations of two experts in epidemiology and biostatistics. About 40%-75% of papers had problems in reporting random allocation method, allocation concealment, random allocation implementation, blinding and similarity among groups, intention to treat and balancing benefits and harms. Moreover, at least 10% of papers inappropriately/not reported the design, protocol violations, sample size justification, subgroup/adjusted analyses, presenting flow diagram, drop outs, recruitment time, baseline data, suitable effect size on outcome, ancillary analyses, limitations and generalizability. Considering the shortcomings found and due to the importance of the RCTs for fall injury prevention programmes, their reporting quality should be improved.

  9. Lessons in participant retention in the course of a randomized controlled clinical trial.

    Science.gov (United States)

    Idoko, Olubukola T; Owolabi, Olumuyiwa A; Odutola, Aderonke A; Ogundare, Olatunde; Worwui, Archibald; Saidu, Yauba; Smith-Sanneh, Alison; Tunkara, Abdoulie; Sey, Gibbi; Sanyang, Assan; Mendy, Philip; Ota, Martin O C

    2014-10-09

    Clinical trials are increasingly being conducted as new products seek to enter the market. Deployment of such interventions is based on evidence obtained mainly from the gold standard of randomized controlled clinical trials (RCCT). A crucial factor in the ability of RCCTs to provide credible and generalisable data is sample size and retention of the required number of subjects at completion of the follow-up period. However, recruitment and retention in clinical trials are hindered by prevalent peculiar challenges in Africa that need to be circumvented. This article shares experiences from a phase II trial that recorded a high retention rate at 14 months follow-up at a new clinical trial site. Mothers bringing children less than two months of age to the health facility were given information and invited to have their child enrolled if the inclusion criteria were fulfilled. Participants were enrolled over 8 months. Trial procedures, duration and risks/benefits were painstakingly and sequentially explained to the communities, parents and relevant relatives before and during the trial period. The proportions of participants that completed or did not complete the trial were analyzed including the reasons for failure to complete all trial procedures. 1044 individuals received information regarding the trial of which 371 returned for screening. 300 (81%) of them who fulfilled the inclusion criteria and did not meet any exclusion criteria were enrolled and 94% of these completed the trial. Consent withdrawal was the main reason for not completing the trial largely (75%) due to the father not being involved at the point of consenting or parents no longer being comfortable with blood sampling. Participant retention in clinical trials remains a crucial factor in ensuring generalisability of trial data. Appropriate measures to enhance retention should include continuous community involvement in the process, adequate explanation of trial procedures and risks/benefits; and

  10. Control of thermal therapies with moving power deposition field

    International Nuclear Information System (INIS)

    Arora, Dhiraj; Minor, Mark A; Skliar, Mikhail; Roemer, Robert B

    2006-01-01

    A thermal therapy feedback control approach to control thermal dose using a moving power deposition field is developed and evaluated using simulations. A normal tissue safety objective is incorporated in the controller design by imposing constraints on temperature elevations at selected normal tissue locations. The proposed control technique consists of two stages. The first stage uses a model-based sliding mode controller that dynamically generates an 'ideal' power deposition profile which is generally unrealizable with available heating modalities. Subsequently, in order to approximately realize this spatially distributed idealized power deposition, a constrained quadratic optimizer is implemented to compute intensities and dwell times for a set of pre-selected power deposition fields created by a scanned focused transducer. The dwell times for various power deposition profiles are dynamically generated online as opposed to the commonly employed a priori-decided heating strategies. Dynamic intensity and trajectory generation safeguards the treatment outcome against modelling uncertainties and unknown disturbances. The controller is designed to enforce simultaneous activation of multiple normal tissue temperature constraints by rapidly switching between various power deposition profiles. The hypothesis behind the controller design is that the simultaneous activation of multiple constraints substantially reduces treatment time without compromising normal tissue safety. The controller performance and robustness with respect to parameter uncertainties is evaluated using simulations. The results demonstrate that the proposed controller can successfully deliver the desired thermal dose to the target while maintaining the temperatures at the user-specified normal tissue locations at or below the maximum allowable values. Although demonstrated for the case of a scanned focused ultrasound transducer, the developed approach can be extended to other heating modalities with

  11. Complementary feeding: a Global Network cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Pasha Omrana

    2011-01-01

    Full Text Available Abstract Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months; neurocognitive development (12 and 18 months; and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will

  12. Ensemble control of the Hardhof well field under constraints

    Science.gov (United States)

    Marti, Beatrice; McLaughlin, Dennis; Kinzelbach, Wolfgang; Kaiser, Hans-Peter

    2013-04-01

    Practical control of flow in aquifers has been based on deterministic models, not including stochastic information in the optimization (Bauser et al., 2010 or Marti et al., 2012). Only recently robust ensemble control of aquatic systems has been analyzed in linear and synthetic problems (Lin, B., 2012). We propose a control under constraints, which takes into account the stochastic information contained in an ensemble of realizations of a groundwater flow model with uncertain parameters, boundary and initial conditions. This control is applied to a real life problem setting (the Hardhof well field in Zurich) and analyzed with regard to efficiency of the control compared to a similar control based on a deterministic model. The Hardhof well field, which lies in the city of Zurich, Switzerland, provides roughly 15% of the town's drinking water demand from the Limmat valley aquifer. Groundwater and river filtrate are withdrawn in four large horizontal wells, each with a capacity of up to 48'000 m3 per day. The well field is threatened by potential pollution from leachate of a nearby land fill, possible accidents on the adjacent rail and road lines, and by diffuse pollution from former industrial sites and sewers located upstream of the well field. A line of recharge wells and basins forms a hydraulic barrier against the potentially contaminated water and increases the capacity of the well field. The amount and distribution of the artificial recharge to 3 infiltration basins and 12 infiltration wells has to be controlled on a daily basis to guarantee the effectiveness of the hydraulic barrier in the highly dynamic flow field. The Hardhof well field is simulated with a 2D-real-time groundwater flow model. The model is coupled to a controller, minimizing the inflow of potentially contaminated groundwater to the drinking water wells under various constraints (i.e. keeping the groundwater level between given thresholds, guaranteeing production of the drinking water demand

  13. End-tidal control vs. manually controlled minimal-flow anesthesia: a prospective comparative trial.

    Science.gov (United States)

    Wetz, A J; Mueller, M M; Walliser, K; Foest, C; Wand, S; Brandes, I F; Waeschle, R M; Bauer, M

    2017-11-01

    To ensure safe general anesthesia, manually controlled anesthesia requires constant monitoring and numerous manual adjustments of the gas dosage, especially for low- and minimal-flow anesthesia. Oxygen flow-rate and administration of volatile anesthetics can also be controlled automatically by anesthesia machines using the end-tidal control technique, which ensures constant end-tidal concentrations of oxygen and anesthetic gas via feedback and continuous adjustment mechanisms. We investigated the hypothesis that end-tidal control is superior to manually controlled minimal-flow anesthesia (0.5 l/min). In this prospective trial, we included 64 patients undergoing elective surgery under general anesthesia. We analyzed the precision of maintenance of the sevoflurane concentration (1.2-1.4%) and expiratory oxygen (35-40%) and the number of necessary adjustments. Target-concentrations of sevoflurane and oxygen were maintained at more stable levels with the use of end-tidal control (during the first 15 min 28% vs. 51% and from 15 to 60 min 1% vs. 19% deviation from sevoflurane target, P tidal oxygen (5, IQR 3-6). The target-concentrations were reached earlier with the use of end-tidal compared with manual controlled minimal-flow anesthesia but required slightly greater use of anesthetic agents (6.9 vs. 6.0 ml/h). End-tidal control is a superior technique for setting and maintaining oxygen and anesthetic gas concentrations in a stable and rapid manner compared with manual control. Consequently, end-tidal control can effectively support the anesthetist. © 2017 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  14. Original sound compositions reduce anxiety in emergency department patients: a randomised controlled trial.

    Science.gov (United States)

    Weiland, Tracey J; Jelinek, George A; Macarow, Keely E; Samartzis, Philip; Brown, David M; Grierson, Elizabeth M; Winter, Craig

    2011-12-19

    To determine whether emergency department (ED) patients' self-rated levels of anxiety are affected by exposure to purpose-designed music or sound compositions with and without the audio frequencies of embedded binaural beat. Randomised controlled trial in an ED between 1 February 2010 and 14 April 2010 among a convenience sample of adult patients who were rated as category 3 on the Australasian Triage Scale. All interventions involved listening to soundtracks of 20 minutes' duration that were purpose-designed by composers and sound-recording artists. Participants were allocated at random to one of five groups: headphones and iPod only, no soundtrack (control group); reconstructed ambient noise simulating an ED but free of clear verbalisations; electroacoustic musical composition; composed non-musical soundtracks derived from audio field recordings obtained from natural and constructed settings; sound composition of audio field recordings with embedded binaural beat. All soundtracks were presented on an iPod through headphones. Patients and researchers were blinded to allocation until interventions were administered. State-trait anxiety was self-assessed before the intervention and state anxiety was self-assessed again 20 minutes after the provision of the soundtrack. Spielberger State-Trait Anxiety Inventory. Of 291 patients assessed for eligibility, 170 patients completed the pre-intervention anxiety self-assessment and 169 completed the post-intervention assessment. Significant decreases (all P beats (43; 37) when compared with those allocated to receive simulated ED ambient noise (40; 41) or headphones only (44; 44). In moderately anxious ED patients, state anxiety was reduced by 10%-15% following exposure to purpose-designed sound interventions. Australian New Zealand Clinical Trials Registry ACTRN 12608000444381.

  15. Blinding in randomized control trials: the enigma unraveled.

    Directory of Open Access Journals (Sweden)

    Vartika Saxena

    2016-03-01

    Full Text Available The search for new treatments and testing of new ideas begins in the laboratory and then established in clinical research settings. Studies addressing the same therapeutic problem may produce conflicting results hence Randomised Clinical Trial is regarded as the most valid method for assessing the benefits and harms of healthcare interventions. The next challenge face by the medical community is the validity of such trials as theses tend to deviate from the truth because of various biases. For the avoidance of the same it has been suggested that the validity or quality of primary trials should be assessed under blind conditions. Thus blinding, is a crucial method for reducing bias in randomized clinical trials. Blinding can be defined as withholding information about the assigned interventions from people involved in the trial who may potentially be prejudiced by this knowledge. In this article we make an effort to define blinding, explain its chronology, hierarchy and discuss methods of blinding, its assessment, its possibility, un-blinding and finally the latest guidelines.

  16. Field trials to evaluate effects of continuously planted transgenic insect-resistant cottons on soil invertebrates.

    Science.gov (United States)

    Li, Xiaogang; Liu, Biao; Wang, Xingxiang; Han, Zhengmin; Cui, Jinjie; Luo, Junyu

    2012-03-01

    Impacts on soil invertebrates are an important aspect of environmental risk assessment and post-release monitoring of transgenic insect-resistant plants. The purpose of this study was to research and survey the effects of transgenic insect-resistant cottons that had been planted over 10 years on the abundance and community structure of soil invertebrates under field conditions. During 3 consecutive years (2006-2008), eight common taxa (orders) of soil invertebrates belonging to the phylum Arthropoda were investigated in two different transgenic cotton fields and one non-transgenic cotton field (control). Each year, soil samples were taken at four different growth stages of cotton (seedling, budding, boll forming and boll opening). Animals were extracted from the samples using the improved Tullgren method, counted and determined to the order level. The diversity of the soil fauna communities in the different fields was compared using the Simpson's, Shannon's diversity indices and evenness index. The results showed a significant sampling time variation in the abundance of soil invertebrates monitored in the different fields. However, no difference in soil invertebrate abundance was found between the transgenic cotton fields and the control field. Both sampling time and cotton treatment had a significant effect on the Simpson's, Shannon's diversity indices and evenness index. They were higher in the transgenic fields than the control field at the growth stages of cotton. Long-term cultivation of transgenic insect-resistant cottons had no significant effect on the abundance of soil invertebrates. Collembola, Acarina and Araneae could act as the indicators of soil invertebrate in this region to monitor the environmental impacts of transgenic plants in the future. This journal is © The Royal Society of Chemistry 2012

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

    Directory of Open Access Journals (Sweden)

    Schlitt Hans

    2010-04-01

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

  18. Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions.

    Directory of Open Access Journals (Sweden)

    Stephanie Coronado-Montoya

    Full Text Available A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified.CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses.108 (87% of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88% concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7. Of 21 trial registrations, 13 (62% remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases.The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice.

  19. Maximising the value of combining qualitative research and randomised controlled trials in health research: the QUAlitative Research in Trials (QUART) study--a mixed methods study.

    Science.gov (United States)

    O'Cathain, Alicia; Thomas, Kate J; Drabble, Sarah J; Rudolph, Anne; Goode, Jackie; Hewison, Jenny

    2014-06-01

    Researchers sometimes undertake qualitative research with randomised controlled trials (RCTs) of health interventions. To systematically explore how qualitative research is being used with trials and identify ways of maximising its value to the trial aim of providing evidence of effectiveness of health interventions. A sequential mixed methods study with four components. (1) Database search of peer-reviewed journals between January 2008 and September 2010 for articles reporting the qualitative research undertaken with specific trials, (2) systematic search of database of registered trials to identify studies combining qualitative research and trials, (3) survey of 200 lead investigators of trials with no apparent qualitative research and (4) semistructured telephone interviews with 18 researchers purposively sampled from the first three methods. Qualitative research was undertaken with at least 12% of trials. A large number of articles reporting qualitative research undertaken with trials (n=296) were published between 2008 and 2010. A total of 28% (82/296) of articles reported qualitative research undertaken at the pre-trial stage and around one-quarter concerned drugs or devices. The articles focused on 22 aspects of the trial within five broad categories. Some focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356), the design and conduct of the trial (15%, 54/356), the outcomes of the trial (1%, 5/356), the measures used in the trial (3%, 10/356), and the health condition in the trial (9%, 33/356). The potential value of the qualitative research to the trial endeavour included improving the external validity of trials and facilitating interpretation of trial findings. This value could be maximised by using qualitative research more at the pre-trial stage and reporting findings with explicit attention to the implications for the trial endeavour. During interviews

  20. Acupuncture for treating polycystic ovary syndrome: guidance for future randomized controlled trials

    OpenAIRE

    Wu, Y; Robinson, N; Hardiman, PJ; Taw, MB; Zhou, J; Wang, FF; Qu, F

    2016-01-01

    Objective: To provide guidance for future randomized controlled trials (RCTs) based on a review concerning acupuncture for treating polycystic ovary syndrome (PCOS). Methods: A comprehensive literature search was conducted in October 2015 using MEDLINE, EMBASE, SCISEARCH, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Menstrual Disorders and Subfertility Group trials register, Allied and Complementary Medicine (AMED), China National Knowledge Infrastructure (CNKI), and...

  1. Ipsilateral transversus abdominis plane block provides effective analgesia after appendectomy in children: a randomized controlled trial.

    LENUS (Irish Health Repository)

    Carney, John

    2010-10-01

    The transversus abdominis plane (TAP) block provides effective postoperative analgesia in adults undergoing major abdominal surgery. Its efficacy in children remains unclear, with no randomized clinical trials in this population. In this study, we evaluated its analgesic efficacy over the first 48 postoperative hours after appendectomy performed through an open abdominal incision, in a randomized, controlled, double-blind clinical trial.

  2. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    Science.gov (United States)

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  3. The challenge of recruiting patients into a placebo-controlled surgical trial

    DEFF Research Database (Denmark)

    Hare, Kristoffer B; Lohmander, L Stefan; Roos, Ewa M.

    2014-01-01

    BACKGROUND: Randomized placebo-controlled trials represent the gold standard in evaluating healthcare interventions but are rarely performed within orthopedics. Ethical concerns or well-known challenges in recruiting patients for surgical trials in general have been expressed and adding a placebo...

  4. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    NARCIS (Netherlands)

    O’Cathain, A.; Hoddinott, P.; Lewin, S.; Thomas, K.J.; Young, B.; Adamson, J.; Jansen, J.F.M.; Mills, N.; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full

  5. Field trial of GABA-fortified rice plants and oral administration of milled rice in spontaneously hypertensive rats.

    Science.gov (United States)

    Kowaka, Emi; Shimajiri, Yasuka; Kawakami, Kouhei; Tongu, Miki; Akama, Kazuhito

    2015-06-01

    Hypertension is one of the most critical risk factors accompanying cardiovascular diseases. γ-Aminobutyric acid (GABA) is a non-protein amino acid that functions as a major neurotransmitter in mammals and also as a blood-pressure lowering agent. We previously produced GABA-fortified rice lines of a popular Japonica rice cultivar 'Koshihikari' by genetic manipulation of GABA shunt-related genes. In the study reported here, we grew these same novel rice lines in a field trial and administered the milled rice orally to rats. The yield parameters of the transgenic rice plants were almost unchanged compared to those of untransformed cv. 'Koshihikari' plants, while the rice grains of the transgenic plants contained a high GABA content (3.5 g GABA/kg brown rice; 0.75-0.85 GABA g/kg milled rice) in a greenhouse trial. Oral administration of a diet containing 2.5% GABA-fortified rice, with a daily intake for 8 weeks, had an approximately 20 mmHg anti-hypertensive effect in spontaneous hypertensive rats but not in normotensive Wistar-Kyoto rats. These results suggest that GABA-fortified rice may be applicable as a staple food to control or prevent hypertension.

  6. User experiences with editorial control in online newspaper comment fields

    DEFF Research Database (Denmark)

    Løvlie, Anders Sundnes; Ihlebæk, Karoline Andrea; Larsson, Anders Olof

    2017-01-01

    This article investigates user experiences with editorial control in online newspaper comment fields following the public backlash against online comments after the 2011 terror attacks in Norway. We analyze data from a survey of online news consumers focusing on experiences and attitudes towards...... editorial control set against a spectrum between “interventionist” and “noninterventionist” positions. Results indicate that interventionist respondents rate the quality of online comments as poor, whereas noninterventionist respondents have most often experienced being the target of editorial control...... measures and feel that editorial control has intensified after the terror attacks. We conclude that newspapers should pay attention to the different needs of participants when devising strategies for editorial control. Media professionals should also consider changes to increase the transparency...

  7. A Multiposture Locomotor Training Device with Force-Field Control

    Directory of Open Access Journals (Sweden)

    Jianfeng Sui

    2014-11-01

    Full Text Available This paper introduces a multiposture locomotor training device (MPLTD with a closed-loop control scheme based on joint angle feedback, which is able to overcome various difficulties resulting from mechanical vibration and the weight of trainer to achieve higher accuracy trajectory. By introducing the force-field control scheme used in the closed-loop control, the device can obtain the active-constrained mode including the passive one. The MPLTD is mainly composed of three systems: posture adjusting and weight support system, lower limb exoskeleton system, and control system, of which the lower limb exoskeleton system mainly includes the indifferent equilibrium mechanism with two degrees of freedom (DOF and the driving torque is calculated by the Lagrangian function. In addition, a series of experiments, the weight support and the trajectory accuracy experiment, demonstrate a good performance of mechanical structure and the closed-loop control.

  8. Twenty-year perspective of randomized controlled trials for surgery of chronic nonspecific low back pain: citation bias and tangential knowledge.

    Science.gov (United States)

    Andrade, Nicholas S; Flynn, John P; Bartanusz, Viktor

    2013-11-01

    After decades of clinical research, the role of surgery for chronic nonspecific low back pain (CNLBP) remains equivocal. Despite significant intellectual, human, and economic investments into randomized controlled trials (RCTs) in the past two decades, the role of surgery in the treatment for CNLBP has not been clarified. To delineate the historical research agenda of surgical RCTs for CNLBP performed between 1993 and 2012 investigating whether conclusions from earlier published trials influenced the choice of research questions of subsequent RCTs on elucidating the role of surgery in the management of CNLBP. Literature review. We searched the literature for all RCTs involving surgery for CNLBP. We reviewed relevant studies to identify the study question, comparator arms, and sample size. Randomized controlled trials were classified as "indication" trials if they evaluated the effectiveness of surgical therapy versus nonoperative care or as "technical" if they compared different surgical techniques, adjuncts, or procedures. We used citation analysis to determine the impact of trials on subsequent research in the field. Altogether 33 technical RCTs (3,790 patients) and 6 indication RCTs (981 patients) have been performed. Since 2007, despite the unclear benefits of surgery reported by the first four indication trials published in 2001 to 2006, technical trials have continued to predominate (16 vs. 2). Of the technical trials, types of instrumentation (13 trials, 1,332 patients), bone graft materials and substitutes (11 trials, 833 patients), and disc arthroplasty versus fusion (5 trials, 1,337 patients) were the most common comparisons made. Surgeon authors have predominantly cited one of the indication trials that reported more favorable results for surgery, despite a lack of superior methodology or sample size. Trials evaluating bone morphogenic protein, instrumentation, and disc arthroplasty were all cited more frequently than the largest trial of surgical versus

  9. Time-delay effects and simplified control fields in quantum Lyapunov control

    International Nuclear Information System (INIS)

    Yi, X X; Wu, S L; Wu, Chunfeng; Feng, X L; Oh, C H

    2011-01-01

    Lyapunov-based quantum control has the advantage that it is free from the measurement-induced decoherence and it includes the instantaneous information of the system in the control. The Lyapunov control is often confronted with time delay in the control fields and difficulty in practical implementations of the control. In this paper, we study the effect of time delay on the Lyapunov control and explore the possibility of replacing the control field with a pulse train or a bang-bang signal. The efficiency of the Lyapunov control is also presented through examining the convergence time of the system. These results suggest that the Lyapunov control is robust against time delay, easy to realize and effective for high-dimensional quantum systems.

  10. Lansoprazole for children with poorly controlled asthma: a randomized controlled trial.

    Science.gov (United States)

    Holbrook, Janet T; Wise, Robert A; Gold, Benjamin D; Blake, Kathryn; Brown, Ellen D; Castro, Mario; Dozor, Allen J; Lima, John J; Mastronarde, John G; Sockrider, Marianna M; Teague, W Gerald

    2012-01-25

    Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. Untreated GER has been postulated to be a cause of inadequate asthma control in children despite inhaled corticosteroid treatment, but it is not known whether treatment with proton pump inhibitors improves asthma control. To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER. The Study of Acid Reflux in Children With Asthma, a randomized, masked, placebo-controlled, parallel clinical trial that compared lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment. Three hundred six participants enrolled from April 2007 to September 2010 at 19 US academic clinical centers were followed up for 24 weeks. A subgroup had an esophageal pH study before randomization. Participating children were randomly assigned to receive either lansoprazole, 15 mg/d if weighing less than 30 kg or 30 mg/d if weighing 30 kg or more (n = 149), or placebo (n = 157). The primary outcome measure was change in Asthma Control Questionnaire (ACQ) score (range, 0-6; a 0.5-unit change is considered clinically meaningful). Secondary outcome measures included lung function measures, asthma-related quality of life, and episodes of poor asthma control. The mean age was 11 years (SD, 3 years). The mean difference in change (lansoprazole minus placebo) in the ACQ score was 0.2 units (95% CI, 0.0-0.3 units). There were no statistically significant differences in the mean difference in change for the secondary outcomes of forced expiratory volume in the first second (0.0 L; 95% CI, -0.1 to 0.1 L), asthma-related quality of life (-0.1; 95% CI, -0.3 to 0.1), or rate of episodes of poor asthma control (relative risk, 1.2; 95% CI, 0.9-1.5). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole vs placebo was observed for

  11. DeLLITE Depression in late life: an intervention trial of exercise. Design and recruitment of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Keeling Sally

    2008-05-01

    Full Text Available Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years and older with depressive symptoms. The intervention involves an individualised activity programme based on goal setting and progression of difficulty of activities delivered by a trained nurse during 8 home visits over 6 months. The control group received time matched home visits to discuss social contacts and networks. Baseline, 6 and 12 months measures were assessed in face to face visits with the primary outcome being functional status (SPPB, NEADL. Secondary outcomes include depressive symptoms (Geriatric Depression Scale, quality of life (SF-36, physical activity (AHS Physical Activity Questionnaire and falls (self report. Discussion Due to report in 2008 the DeLLITE study has recruited 70% of those eligible and tests the efficacy of a home based, goal setting physical activity programme in improving function, mood and quality of life in older people with depressive symptomatology. If successful in improving function and mood this trial could prove for the first time that there are long term health benefit of physical activity, independent of social activity, in this high risk group who consume excess health related costs. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12605000475640

  12. Quantum control mechanism analysis through field based Hamiltonian encoding

    International Nuclear Information System (INIS)

    Mitra, Abhra; Rabitz, Herschel

    2006-01-01

    Optimal control of quantum dynamics in the laboratory is proving to be increasingly successful. The control fields can be complex, and the mechanisms by which they operate have often remained obscure. Hamiltonian encoding (HE) has been proposed as a method for understanding mechanisms in quantum dynamics. In this context mechanism is defined in terms of the dominant quantum pathways leading to the final state of the controlled system. HE operates by encoding a special modulation into the Hamiltonian and decoding its signature in the dynamics to determine the dominant pathway amplitudes. Earlier work encoded the modulation directly into the Hamiltonian operators. This present work introduces the alternative scheme of field based HE, where the modulation is encoded into the control field and not directly into the Hamiltonian operators. This distinct form of modulation yields a new perspective on mechanism and is computationally faster than the earlier approach. Field based encoding is also an important step towards a laboratory based algorithm for HE as it is the only form of encoding that may be experimentally executed. HE is also extended to cover systems with noise and uncertainty and finally, a hierarchical algorithm is introduced to reveal mechanism in a stepwise fashion of ever increasing detail as desired. This new hierarchical algorithm is an improvement over earlier approaches to HE where the entire mechanism was determined in one stroke. The improvement comes from the use of less complex modulation schemes, which leads to fewer evaluations of Schroedinger's equation. A number of simulations are presented on simple systems to illustrate the new field based encoding technique for mechanism assessment

  13. Quality control for digital mammography: Part II recommendations from the ACRIN DMIST trial

    International Nuclear Information System (INIS)

    Yaffe, Martin J.; Bloomquist, Aili K.; Mawdsley, Gordon E.

    2006-01-01

    The Digital Mammography Imaging Screening Trial (DMIST), conducted under the auspices of the American College of Radiology Imaging Network (ACRIN), is a clinical trial designed to compare the accuracy of digital versus screen-film mammography in a screening population [E. Pisano et al., ACRIN 6652--Digital vs. Screen-Film Mammography, ACRIN (2001)]. Part I of this work described the Quality Control program developed to ensure consistency and optimal operation of the digital equipment. For many of the tests, there were no failures during the 24 months imaging was performed in DMIST. When systems failed, they generally did so suddenly rather than through gradual deterioration of performance. In this part, the utility and effectiveness of those tests are considered. This suggests that after verification of proper operation, routine extensive testing would be of minimal value. A recommended set of tests is presented including additional and improved tests, which we believe meet the intent and spirit of the Mammography Quality Standards Act regulations to ensure that full-field digital mammography systems are functioning correctly, and consistently producing mammograms of excellent image quality

  14. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Evelim L F D Gomes

    Full Text Available The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma.A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20 or a treadmill group (TG; n = 16. Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO, maximum exercise testing (Bruce protocol and lung function.No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05. Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG.The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation.Clinicaltrials.gov NCT01438294.

  15. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

    Science.gov (United States)

    Gomes, Evelim L F D; Carvalho, Celso R F; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation. Clinicaltrials.gov NCT01438294.

  16. Control of Root Rot and Wilt Diseases of Roselle under Field Conditions

    Science.gov (United States)

    Hassan, Naglaa; Elsharkawy, Mohsen Mohamed; Shimizu, Masafumi

    2014-01-01

    Roselle (Hibiscus sabdariffa L.) is one of the most important medicinal crops in many parts of the world. In this study, the effects of microelements, antioxidants, and bioagents on Fusarium oxysporum, F. solani, and Macrophomina phaseolina, the causal pathogens of root rot and wilt diseases in roselle, were examined under field conditions. Preliminary studies were carried out in vitro in order to select the most effective members to be used in field control trials. Our results showed that microelements (copper and manganese), antioxidants (salicylic acid, ascorbic acid, and EDTA), a fungicide (Dithane M45) and biological control agents (Trichoderma harzianum and Bacillus subtilis) were significantly reduced the linear growth of the causal pathogens. Additionally, application of the previous microelements, antioxidants, a fungicide and biological control agents significantly reduced disease incidence of root rot and wilt diseases under field conditions. Copper, salicylic acid, and T. harzianum showed the best results in this respect. In conclusion, microelements, antioxidants, and biocontrol agents could be used as alternative strategies to fungicides for controlling root rot and wilt diseases in roselle. PMID:25606010

  17. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  18. Recruitment of black and Latina women to a randomized controlled trial.

    Science.gov (United States)

    Martin, Anika; Negron, Rennie; Balbierz, Amy; Bickell, Nina; Howell, Elizabeth A

    2013-08-01

    Minority women are often not adequately represented in randomized controlled trials, limiting the generalizability of research trial results. We implemented a recruitment strategy for a postpartum depression prevention trial that utilized patient feedback to identify and understand the recruitment barriers of black and Latina postpartum women. Feedback on patients' reasons for trial refusal informed adaptations to the recruitment process. We calculated weekly recruitment rates and analyzed qualitative and quantitative data from patient refusals. Of the 668 women who were approached and completed the consent process, 540 enrolled in the trial and 128 declined participation. Over 52-weeks of recruitment, refusal rates decreased from 40% to 19%. A taxonomy of eight reasons for refusal derived from patient responses identified barriers to recruitment and generated targeted revisions to the recruitment message. A recruitment strategy designed to incorporate and respond to patient feedback improved recruitment of Black and Latina women to a clinical trial.

  19. The Paracetamol (Acetaminophen) In Stroke (PAIS) trial : a multicentre, randomised, placebo-controlled, phase III trial

    NARCIS (Netherlands)

    den Hertog, Heleen M.; van der Worp, H. Bart; van Gemert, H. Maarten A.; Algra, Ate; Kappelle, L. Jaap; Van Gijn, Jan; Koudstaal, Peter J.; Dippel, Diederik W. J.

    Background High body temperature in the first 12-24 h after stroke onset is associated with poor functional outcome. The Paracetamol (Acetaminophen) In Stroke (PAIS) trial aimed to assess whether early treatment with paracetamol improves functional outcome in patients with acute stroke by reducing

  20. Randomized, Controlled Trial of CBT Training for PTSD Providers

    Science.gov (United States)

    2015-10-01

    PI, program manager, and two research assistants will guide the mixed-method coding, analysis, and synthesis of the three consultation data sources...A randomized clinical trial of eye movement desensitization and reprocessing (EMDR), fluoxetine , and pill placebo in the treatment of

  1. Beyond Randomized Controlled Trials in Attempted Suicide Research

    Science.gov (United States)

    Hatcher, Simon; Sharon, Cynthia; Coggan, Carol

    2009-01-01

    There is a lack of evidence about what is the best treatment for people who present to hospital after self harm. Most treatment trials have been small and involved unrepresentative groups of patients which result in inconclusive findings. Here we note some of the characteristics of attempted suicide which make it a difficult subject to study. We…

  2. Fractional nonablative 1,540-nm laser resurfacing of atrophic acne scars. A randomized controlled trial with blinded response evaluation

    DEFF Research Database (Denmark)

    Hedelund, Lene; Moreau, Karen Estell R; Beyer, Ditte M

    2010-01-01

    as moderately or significantly improved. No differences were found in skin redness or pigmentation between before and after treatment. Patients experienced moderate pain, erythema, oedema, bullae, and crusts. No adverse effects were seen in untreated control areas. The nonablative 1,540-nm fractional laser......The efficacy of nonablative fractional laser resurfacing of acne scars has been described in case reports and uncontrolled trials. The present study is the first randomized controlled trial in this field. The aim of this study was to examine the efficacy and adverse effects of 1,540-nm nonablative...... fractional laser treatment of acne scars. Ten patients with acne scars were included. Two intraindividual areas of similar size and appearance within contralateral anatomical regions were randomized to (1) 3-monthly laser treatments with a StarLux 1,540-nm fractional handpiece, and (2) no treatment. Blinded...

  3. A quality assessment of randomized controlled trial reports in endodontics.

    Science.gov (United States)

    Lucena, C; Souza, E M; Voinea, G C; Pulgar, R; Valderrama, M J; De-Deus, G

    2017-03-01

    To assess the quality of the randomized clinical trial (RCT) reports published in Endodontics between 1997 and 2012. Retrieval of RCTs in Endodontics was based on a search of the Thomson Reuters Web of Science (WoS) database (March 2013). Quality evaluation was performed using a checklist based on the Jadad criteria, CONSORT (Consolidated Standards of Reporting Trials) statement and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). Descriptive statistics were used for frequency distribution of data. Student's t-test and Welch test were used to identify the influence of certain trial characteristics upon report quality (α = 0.05). A total of 89 RCTs were evaluated, and several methodological flaws were found: only 45% had random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, and 19% were nonblinded designs. Regarding statistics, only 55% of the RCTs performed adequate sample size estimations, only 16% presented confidence intervals, and 25% did not provide the exact P-value. Also, 2% of the articles used no statistical tests, and in 87% of the RCTs, the information provided was insufficient to determine whether the statistical methodology applied was appropriate or not. Significantly higher scores were observed for multicentre trials (P = 0.023), RCTs signed by more than 5 authors (P = 0.03), articles belonging to journals ranked above the JCR median (P = 0.03), and articles complying with the CONSORT guidelines (P = 0.000). The quality of RCT reports in key areas for internal validity of the study was poor. Several measures, such as compliance with the CONSORT guidelines, are important in order to raise the quality of RCTs in Endodontics. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  4. Using Guasha to treat musculoskeletal pain: A systematic review of controlled clinical trials

    Directory of Open Access Journals (Sweden)

    Choi Sun-Mi

    2010-01-01

    Full Text Available Abstract Background Guasha is a therapeutic method for pain management using tools to scrape or rub the surface of the body to relieve blood stagnation. This study aims to systematically review the controlled clinical trials on the effectiveness of using Guasha to treat musculoskeletal pain. Methods We searched 11 databases (without language restrictions: MEDLINE, Allied and Complementary Medicine (AMED, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL, Korean Studies Information (KSI, DBPIA, Korea Institute of Science and Technology Information (KISTI, KoreaMed, Research Information Service System (RISS, China National Knowledge Infrastructure (CNKI and the Cochrane Library. The search strategy was Guasha (OR scraping AND pain. Risk of bias was assessed with the Cochrane criteria (i.e. sequence generation, blinding, incomplete outcome measures and allocation concealment. Results Five randomized controlled trials (RCTs and two controlled clinical trials (CCTs were included in the present study. Two RCTs compared Guasha with acupuncture in terms of effectiveness, while the other trials compared Guasha with no treatment (1 trial, acupuncture (4 trials, herbal injection (1 trial and massage or electric current therapy (1 trial. While two RCTs suggested favorable effects of Guasha on pain reduction and response rate, the quality of these RCTs was poor. One CCT reported beneficial effects of Guasha on musculoskeletal pain but had low methodological quality. Conclusion Current evidence is insufficient to show that Guasha is effective in pain management. Further RCTs are warranted and methodological quality should be improved.

  5. Arthrocentesis as initial treatment for temporomandibular joint arthropathy : A randomized controlled trial

    NARCIS (Netherlands)

    Vos, L. M.; Huddleston Slater, J. J. R.; Stegenga, B.

    Objective: To determine the effectiveness of arthrocentesis compared to conservative treatment as initial treatment with regard to temporomandibular joint pain and mandibular movement. Patients and methods: In this randomized controlled trial, 80 patients with arthralgia of the TMJ (classified

  6. Randomised controlled trial of the efficacy of misoprostol used as a ...

    African Journals Online (AJOL)

    Randomised controlled trial of the efficacy of misoprostol used as a cervical ripening agent prior to termination of pregnancy in the first trimester. Eric T M de Jonge, Rachel Jewkes, Jonathan Levin, Helen Rees ...

  7. Medical prescription of heroin to treatment resistant heroin addicts: two randomised controlled trials

    NARCIS (Netherlands)

    van den Brink, Wim; Hendriks, Vincent M.; Blanken, Peter; Koeter, Maarten W. J.; van Zwieten, Barbara J.; van Ree, Jan M.

    2003-01-01

    OBJECTIVE: To determine whether supervised medical prescription of heroin can successfully treat addicts who do not sufficiently benefit from methadone maintenance treatment. DESIGN: Two open label randomised controlled trials. SETTING: Methadone maintenance programmes in six cities in the

  8. Effect of obstetric team training on team performance and medical technical skills: a randomised controlled trial

    NARCIS (Netherlands)

    Fransen, A.F.; Ven, van de J.; Merién, A.E.R.; Wit-Zuurendonk, de L.D.; Houterman, S.; Mol, B.W.J.; Oei, S.G.

    2012-01-01

    Objective To determine whether obstetric team training in a medical simulation centre improves the team performance and utilisation of appropriate medical technical skills of healthcare professionals. Design Cluster randomised controlled trial. Setting The Netherlands. Sample The obstetric

  9. Randomised Controlled Trial Study of the Effect of TENS and NSAID ...

    African Journals Online (AJOL)

    Randomised Controlled Trial Study of the Effect of TENS and NSAID (Opoid) Drug in the Management of Post Operative Gynaecological Pain. AAG Jimoh, LO Omokanye, GA Salaudeen, ZA Suleiman, K Durowade, EO Adewara ...

  10. Randomized controlled trial of the Pentax AWS, Glidescope, and Macintosh laryngoscopes in predicted difficult intubation.

    LENUS (Irish Health Repository)

    Malik, M A

    2009-11-01

    The purpose of this study was to determine the potential for the Pentax AWS and the Glidescope to reduce the difficulty of tracheal intubation in patients at increased risk for difficult tracheal intubation, in a randomized, controlled clinical trial.

  11. Ursodeoxycholic acid for treatment of primary sclerosing cholangitis: a placebo-controlled trial

    NARCIS (Netherlands)

    Beuers, U.; Spengler, U.; Kruis, W.; AYDEMIR, U.; WIEBECKE, B.; HELDWEIN, W.; WEINZIERL, M.; Pape, G. R.; Sauerbruch, T.; Paumgartner, G.

    1992-01-01

    The efficacy and safety of ursodeoxycholic acid for the treatment of primary sclerosing cholangitis were evaluated in a prospective, randomized, double-blind, placebo-controlled trial. Fourteen patients with primary sclerosing cholangitis documented by cholestatic serum enzyme pattern, liver

  12. Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections: open randomised controlled trial.

    NARCIS (Netherlands)

    Aardweg, M.T. van den; Boonacker, C.W.; Rovers, M.M.; Hoes, A.W.; Schilder, A.G.M.

    2011-01-01

    OBJECTIVE: To assess the effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections. DESIGN: Open randomised controlled trial. SETTING: 11 general hospitals and two academic centres. PARTICIPANTS: 111 children aged 1-6 with recurrent upper respiratory tract

  13. A randomized controlled trial of daily sedation interruption in critically ill children

    NARCIS (Netherlands)

    Vet, N.J.; Wildt, S.N. de; Verlaat, C.W.; Knibbe, C.A.; Mooij, M.G.; Woensel, J.B. van; Rosmalen, J. van; Tibboel, D.; Hoog, M. de

    2016-01-01

    PURPOSE: To compare daily sedation interruption plus protocolized sedation (DSI + PS) to protocolized sedation only (PS) in critically ill children. METHODS: In this multicenter randomized controlled trial in three pediatric intensive care units in the Netherlands, mechanically ventilated critically

  14. A randomized controlled trial of daily sedation interruption in critically ill children

    NARCIS (Netherlands)

    Vet, Nienke J.; de Wildt, Saskia N.; Verlaat, Carin W. M.; Knibbe, Catherijne A. J.; Mooij, Miriam G.; van Woensel, Job B. M.; van Rosmalen, Joost; Tibboel, Dick; de Hoog, Matthijs

    2016-01-01

    To compare daily sedation interruption plus protocolized sedation (DSI + PS) to protocolized sedation only (PS) in critically ill children. In this multicenter randomized controlled trial in three pediatric intensive care units in the Netherlands, mechanically ventilated critically ill children with

  15. The effect of COPD severity and study duration on exacerbation outcome in randomized controlled trials

    NARCIS (Netherlands)

    Eriksson, Goran; Calverley, Peter M.; Jenkins, Christine R.; Anzueto, Antonio R.; Make, Barry J.; Lindberg, Magnus; Fageras, Malin; Postma, Dirkje S.

    2017-01-01

    Background: When discontinuation in COPD randomized controlled trials (RCTs) is unevenly distributed between treatments (differential dropout), the capacity to demonstrate treatment effects may be reduced. We investigated the impact of the time of differential dropout on exacerbation outcomes in

  16. Melodic intonation therapy in chronic aphasia: Evidence from a pilot randomized controlled trial

    NARCIS (Netherlands)

    I. van der Meulen (Ineke); W.M.E. van de Sandt-Koenderman (Mieke); Heijenbrok, M.H. (Majanka H.); E.G. Visch-Brink (Evy); Ribber, G.M. (Gerard M.)

    2016-01-01

    textabstractMelodic Intonation Therapy (MIT) is a language production therapy for severely nonfluent aphasic patients using melodic intoning and rhythm to restore language. Although many studies have reported its beneficial effects on language production, randomized controlled trials (RCT) examining

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

    African Journals Online (AJOL)

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

  18. Sodium Restriction in Patients With CKD : A Randomized Controlled Trial of Self-management Support

    NARCIS (Netherlands)

    Meuleman, Yvette; Hoekstra, Tiny; Dekker, Friedo W.; Navis, Gerjan; Vogt, Liffert; van der Boog, Paul J. M.; Bos, Willem Jan W.; van Montfrans, Gert A.; van Dijk, Sandra

    Background: To evaluate the effectiveness and sustainability of self-managed sodium restriction in patients with chronic kidney disease. Study Design: Open randomized controlled trial. Setting & Participants: Patients with moderately decreased kidney function from 4 hospitals in the Netherlands.

  19. A randomised controlled trial of early initiation of oral feeding after ...

    African Journals Online (AJOL)

    A randomised controlled trial of early initiation of oral feeding after Caesarean ... The outcome measures were rate of ileus symptoms, post operative presence of ... more rapid recovery and expressed their interest in earlier hospital discharge.

  20. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity

    Directory of Open Access Journals (Sweden)

    Birtwhistle Richard

    2003-12-01

    Full Text Available Abstract Background Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results and internal validity (reliability or accuracy of the results needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity. Discussion External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions. Internal validity is maximized by decreasing contamination bias through cluster randomization, and decreasing observer and assessment bias, in these non-blinded trials, through baseline data collection prior to randomization, automating the outcomes assessment with 24 hour ambulatory blood pressure monitors, and blinding the data analysis. Summary Clinical trials conducted in community practices present investigators with difficult methodological choices related to maintaining a balance between internal validity (reliability of the results and external validity (generalizability. The attempt to achieve methodological purity can

  1. A Mock Randomized Controlled Trial With Audience Response Technology for Teaching and Learning Epidemiology.

    Science.gov (United States)

    Baker, Philip R A; Francis, Daniel P; Cathcart, Abby

    2017-04-01

    The study's objective was to apply and assess an active learning approach to epidemiology and critical appraisal. Active learning comprised a mock, randomized controlled trial (RCT) conducted with learners in 3 countries. The mock trial consisted of blindly eating red Smarties candy (intervention) compared to yellow Smarties (control) to determine whether red Smarties increase happiness. Audience response devices were employed with the 3-fold purposes to produce outcome data for analysis of the effects of red Smarties, identify baseline and subsequent changes in participant's knowledge and confidence in understanding of RCTs, and assess the teaching approach. Of those attending, 82% (117 of 143 learners) participated in the trial component. Participating in the mock trial was a positive experience, and the use of the technology aided learning. The trial produced data that learners analyzed in "real time" during the class. The mock RCT is a fun and engaging approach to teaching RCTs and helping students to develop skills in critical appraisal.

  2. Wave field synthesis, adaptive wave field synthesis and ambisonics using decentralized transformed control: Potential applications to sound field reproduction and active noise control

    Science.gov (United States)

    Gauthier, Philippe-Aubert; Berry, Alain; Woszczyk, Wieslaw

    2005-09-01

    Sound field reproduction finds applications in listening to prerecorded music or in synthesizing virtual acoustics. The objective is to recreate a sound field in a listening environment. Wave field synthesis (WFS) is a known open-loop technology which assumes that the reproduction environment is anechoic. Classical WFS, therefore, does not perform well in a real reproduction space such as room. Previous work has suggested that it is physically possible to reproduce a progressive wave field in-room situation using active control approaches. In this paper, a formulation of adaptive wave field synthesis (AWFS) introduces practical possibilities for an adaptive sound field reproduction combining WFS and active control (with WFS departure penalization) with a limited number of error sensors. AWFS includes WFS and closed-loop ``Ambisonics'' as limiting cases. This leads to the modification of the multichannel filtered-reference least-mean-square (FXLMS) and the filtered-error LMS (FELMS) adaptive algorithms for AWFS. Decentralization of AWFS for sound field reproduction is introduced on the basis of sources' and sensors' radiation modes. Such decoupling may lead to decentralized control of source strength distributions and may reduce computational burden of the FXLMS and the FELMS algorithms used for AWFS. [Work funded by NSERC, NATEQ, Université de Sherbrooke and VRQ.] Ultrasound/Bioresponse to

  3. A Shared Compliance Control for Application in High Radiation Fields

    International Nuclear Information System (INIS)

    Ahn, Sung Ho; Jung, Hoan Sung; Lee, Kye Hong; Kim, Young Ki; Kim, Hark Rho

    2005-01-01

    Bilateral control systems present a technical alternative for intelligent robotic systems performing dexterous tasks in unstructured environments such as a nuclear facility, outer space and underwater. A shared compliance control scheme is proposed for application in high radiation fields in which the force sensor can not be installed because of a radiation effect. A position difference between the master system and the slave system is treated as an equivalent contact force and used for an input to the compliance controller. The compliance controller is implemented by a first order low pass filter and it modifies the position of the master to the reference position. Thus the compliance control task is shared by both the human operator's direct manual control and the autonomous compliance control of the slave system. Consequently, the position of a slave system tracks well the reference position and the compliance of the slave system is autonomously controlled in a contact condition. The simulation results show the excellence of the proposed scheme

  4. Trial Application of Pulse-Field Magnetization to Magnetically Levitated Conveyor System

    Directory of Open Access Journals (Sweden)

    Yoshihito Miyatake

    2012-01-01

    Full Text Available Magnetically levitated conveyor system using superconductors is discussed. The system is composed of a levitated conveyor, magnetic rails, a linear induction motor, and some power supplies. In the paper, pulse-field magnetization is applied to the system. Then, the levitation height and the dynamics of the conveyor are controlled. The static and dynamic characteristics of the levitated conveyor are discussed.

  5. Coherent feedback control of multipartite quantum entanglement for optical fields

    Energy Technology Data Exchange (ETDEWEB)

    Yan, Zhihui; Jia, Xiaojun; Xie, Changde; Peng, Kunchi [State Key Laboratory of Quantum Optics and Quantum Optics Devices, Institute of Opto-Electronics, Shanxi University, Taiyuan, 030006 (China)

    2011-12-15

    Coherent feedback control (CFC) of multipartite optical entangled states produced by a nondegenerate optical parametric amplifier is theoretically studied. The features of the quantum correlations of amplitude and phase quadratures among more than two entangled optical modes can be controlled by tuning the transmissivity of the optical beam splitter in the CFC loop. The physical conditions to enhance continuous variable multipartite entanglement of optical fields utilizing the CFC loop are obtained. The numeric calculations based on feasible physical parameters of realistic systems provide direct references for the design of experimental devices.

  6. Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Freeman Liv M

    2012-07-01

    Full Text Available Abstract Background Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. Methods/design The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia. Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief. Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity, mode of delivery and maternal and neonatal side effects. The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. Discussion This study, considering cost

  7. Continuous control of spin polarization using a magnetic field

    Science.gov (United States)

    Gifford, J. A.; Zhao, G. J.; Li, B. C.; Tracy, Brian D.; Zhang, J.; Kim, D. R.; Smith, David J.; Chen, T. Y.

    2016-05-01

    The giant magnetoresistance (GMR) of a point contact between a Co/Cu multilayer and a superconductor tip varies for different bias voltage. Direct measurement of spin polarization by Andreev reflection spectroscopy reveals that the GMR change is due to a change in spin polarization. This work demonstrates that the GMR structure can be utilized as a spin source and that the spin polarization can be continuously controlled by using an external magnetic field.

  8. Continuous control of spin polarization using a magnetic field

    International Nuclear Information System (INIS)

    Gifford, J. A.; Zhao, G. J.; Li, B. C.; Tracy, Brian D.; Zhang, J.; Kim, D. R.; Smith, David J.; Chen, T. Y.

    2016-01-01

    The giant magnetoresistance (GMR) of a point contact between a Co/Cu multilayer and a superconductor tip varies for different bias voltage. Direct measurement of spin polarization by Andreev reflection spectroscopy reveals that the GMR change is due to a change in spin polarization. This work demonstrates that the GMR structure can be utilized as a spin source and that the spin polarization can be continuously controlled by using an external magnetic field.

  9. Continuous control of spin polarization using a magnetic field

    Energy Technology Data Exchange (ETDEWEB)

    Gifford, J. A.; Zhao, G. J.; Li, B. C.; Tracy, Brian D.; Zhang, J.; Kim, D. R.; Smith, David J.; Chen, T. Y., E-mail: tingyong.chen@asu.edu [Department of Physics, Arizona State University, Tempe, Arizona 85287 (United States)

    2016-05-23

    The giant magnetoresistance (GMR) of a point contact between a Co/Cu multilayer and a superconductor tip varies for different bias voltage. Direct measurement of spin polarization by Andreev reflection spectroscopy reveals that the GMR change is due to a change in spin polarization. This work demonstrates that the GMR structure can be utilized as a spin source and that the spin polarization can be continuously controlled by using an external magnetic field.

  10. The ITER poloidal field system: control and power supplies

    International Nuclear Information System (INIS)

    Mondino, P.L.; Benfatto, I.; Gribov, Y.; Matsukawa, M.; Odajima, K.; Portone, A.; Roshal, A.; Bareyt, B.; Bertolini, E.; Bottereau, J.M.; Huart, M.; Maschio, A.; Bulgakov, S.; Kuchinski, V.

    1995-01-01

    The paper reports the preliminary scenario of the ITER Poloidal Field (PF) system operation, the method used to evaluate the installed power, the basic structure of the circuits and finally the concepts of the preliminary design of control and power supply. The superconducting coils are energized from the HV Grid with conventional AC/DC converters. R and D is required for circuit breakers, make switches and resistors, the basic components of both the switching networks and the discharge circuits. (orig.)

  11. Comprehensive geriatric assessment for older adults admitted to hospital: meta-analysis of randomised controlled trials

    OpenAIRE

    Ellis, G.; Whitehead, M.A.; Robinson, D.; O'Neill, D.; Langhorne, P.

    2011-01-01

    Objective - To evaluate the effectiveness of comprehensive geriatric assessment in hospital for older adults admitted as an emergency.\\ud \\ud Search strategy - We searched the EPOC Register, Cochrane’s Controlled Trials Register, the Database of Abstracts of Reviews of Effects (DARE), Medline, Embase, CINAHL, AARP Ageline, and handsearched high yield journals.\\ud \\ud Selection criteria - Randomised controlled trials of comprehensive geriatric assessment (whether by mobile teams or in designat...

  12. Promoting healthful family meals to prevent obesity: HOME Plus, a randomized controlled trial

    OpenAIRE

    Fulkerson, Jayne A.; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y.

    2015-01-01

    Background Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Methods Families (n?=?160 8-12-yea...

  13. Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials

    OpenAIRE

    de Labra, Carmen; Guimaraes-Pinheiro, Christyanne; Maseda, Ana; Lorenzo, Trinidad; Mill?n-Calenti, Jos? C.

    2015-01-01

    Background Low physical activity has been shown to be one of the most common components of frailty, and interventions have been considered to prevent or reverse this syndrome. The purpose of this systematic review of randomized, controlled trials is to examine the exercise interventions to manage frailty in older people. Methods The PubMed, Web of Science, and Cochrane Central Register of Controlled Trials databases were searched using specific keywords and Medical Subject Headings for random...

  14. Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review

    OpenAIRE

    Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

    2009-01-01

    Luke Perraton, Zuzana Machotka, Saravana KumarInternational Centre for Allied Health Evidence, University of South Australia, Adelaide, South Australia, AustraliaAim: Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials.Method: A systematic review of randomized controlled trials was conducted. Onl...

  15. A low-cost repellent for malaria vectors in the Americas: results of two field trials in Guatemala and Peru.

    Science.gov (United States)

    Moore, Sarah J; Darling, Samuel T; Sihuincha, Moisés; Padilla, Norma; Devine, Gregor J

    2007-08-01

    The cost of mosquito repellents in Latin America has discouraged their wider use among the poor. To address this problem, a low-cost repellent was developed that reduces the level of expensive repellent actives by combining them with inexpensive fixatives that appear to slow repellent evaporation. The chosen actives were a mixture of para-menthane-diol (PMD) and lemongrass oil (LG). To test the efficacy of the repellent, field trials were staged in Guatemala and Peru. Repellent efficacy was determined by human-landing catches on volunteers who wore the experimental repellents, control, or 15% DEET. The studies were conducted using a balanced Latin Square design with volunteers, treatments, and locations rotated each night. In Guatemala, collections were performed for two hours, commencing three hours after repellent application. The repellent provided >98% protection for five hours after application, with a biting pressure of >100 landings per person/hour. The 15% DEET control provided lower protection at 92% (p 46 landings per person/hour. The 20% DEET control provided significantly lower protection at 64% (p < 0.0001). In both locations, the PMD/LG repellent provided excellent protection up to six hours after application against a wide range of disease vectors including Anopheles darlingi. The addition of fixatives to the repellent extended its longevity while enhancing efficacy and significantly reducing its cost to malaria-endemic communities.

  16. A low-cost repellent for malaria vectors in the Americas: results of two field trials in Guatemala and Peru

    Directory of Open Access Journals (Sweden)

    Sihuincha Moisés

    2007-08-01

    Full Text Available Abstract Background The cost of mosquito repellents in Latin America has discouraged their wider use among the poor. To address this problem, a low-cost repellent was developed that reduces the level of expensive repellent actives by combining them with inexpensive fixatives that appear to slow repellent evaporation. The chosen actives were a mixture of para-menthane-diol (PMD and lemongrass oil (LG. Methods To test the efficacy of the repellent, field trials were staged in Guatemala and Peru. Repellent efficacy was determined by human-landing catches on volunteers who wore the experimental repellents, control, or 15% DEET. The studies were conducted using a balanced Latin Square design with volunteers, treatments, and locations rotated each night. Results In Guatemala, collections were performed for two hours, commencing three hours after repellent application. The repellent provided >98% protection for five hours after application, with a biting pressure of >100 landings per person/hour. The 15% DEET control provided lower protection at 92% (p 46 landings per person/hour. The 20% DEET control provided significantly lower protection at 64% (p Conclusion In both locations, the PMD/LG repellent provided excellent protection up to six hours after application against a wide range of disease vectors including Anopheles darlingi. The addition of fixatives to the repellent extended its longevity while enhancing efficacy and significantly reducing its cost to malaria-endemic communities.

  17. Nitrates and bone turnover (NABT) - trial to select the best nitrate preparation: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Bucur, Roxana C; Reid, Lauren S; Hamilton, Celeste J; Cummings, Steven R; Jamal, Sophie A

    2013-09-08

    Organic nitrates uncouple bone turnover, improve bone mineral density, and improve trabecular and cortical components of bone. These changes in turnover, strength and geometry may translate into an important reduction in fractures. However, before proceeding with a large fracture trial, there is a need to identify the nitrate formulation that has both the greatest efficacy (with regards to bone turnover markers) and gives the fewest headaches. Ascertaining which nitrate formulation this may be is the purpose of the current study. This will be an open-label randomized, controlled trial conducted at Women's College Hospital comparing five formulations of nitrates for their effects on bone turnover markers and headache. We will recruit postmenopausal women age 50 years or older with no contraindications to nitroglycerin. Our trial will consist of a run-in phase and a treatment phase. We will enroll 420 women in the run-in phase, each to receive all of the 5 potential treatments in random order for 2 days, each with a 2-day washout period between treatments. Those who tolerate all formulations will enter the 12-week treatment phase and be randomly assigned to one of five groups: 0.3 mg sublingual nitroglycerin tablet, 0.6 mg of the sublingual tablet, a 20 mg tablet of isosorbide mononitrate, a 160 mg nitroglycerin transdermal patch (used for 8 h), and 15 mg of nitroglycerin ointment as used in a previous trial by our group. We will continue enrolment until we have randomized 210 women or 35 women per group. Concentrations of bone formation (bone-specific alkaline phosphatase and procollagen type I N-terminal propeptide) and bone resorption (C-telopeptides of collagen crosslinks and N-terminal crosslinks of collagen) agents will be measured in samples taken at study entry (the start of the run in phase) and 12 weeks. Subjects will record the frequency and severity of headaches daily during the run-in phase and then monthly after that. We will use the 'multiple

  18. IAEA workshop and field trial at the Oak Ridge K-25 Site

    International Nuclear Information System (INIS)

    Hembree, D.M. Jr.; Ross, H.H.; Carter, J.A.

    1995-03-01

    In March 1994, members of the International Safeguards Department in the National Security Program Office (NSPO) hosted an environmental monitoring field trial workshop for International Atomic Energy Agency (IAEA) inspectors. The workshop was held at the Oak Ridge K-25 Site and its primary purpose was to train the inspectors in the techniques needed for effective environmental sample collection and handling. The workshop emphasized both sampling theory and practice. First, detailed techniques for swipe, vegetation, soil, biota, and water-associated sampling were covered in the classroom. Subsequently, the inspectors were divided into three groups for actual sample collection in and around the K-25 locale. The collected samples were processed by the Department of Energy (DOE) Network of Analytical Laboratories using established analytical techniques. This activity is part of the IAEA ''Programme 93+2 in. assessment of measures to enhance IAEA safeguards

  19. Public demonstration projects and field trials: Acceler